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Oregon Bulletin

February 1, 2014

Oregon Health Authority, Public Health Division, Chapter 333

Rule Caption: Health Care Acquired Infection Reporting and Public Disclosure

Adm. Order No.: PH 13-2013

Filed with Sec. of State: 12-26-2013

Certified to be Effective: 1-1-14

Notice Publication Date: 11-1-2013

Rules Ren. & Amend: 409-023-0000 to 333-018-0100, 409-023-0005 to 333-018-0105, 409-023-0010 to 333-018-0110, 409-023-0012 to 333-018-0115, 409-023-0013 to 333-018-0120, 409-023-0015 to 333-018-0125, 409-023-0020 to 333-018-0130, 409-023-0025 to 333-018-0135, 409-023-0030 to 333-018-0140, 409-023-0035 to 333-018-0145

Subject: The Oregon Health Authority, Public Health Division is permanently amending and renumbering OAR 409-023-0000 through 409-023-0035 to 333-018-0100 through 333-018-0145 pertaining to health care acquired infection reporting and public disclosure. The HAI Reporting Program used to be housed in the Office for Oregon Health Policy and Research (chapter 409) but has since been moved to the Public Health Division (chapter 333). HB 2094, passed during the 2013 legislative session, was a technical fix bill for the Public Health Division and one of the provisions of the bill was to amend statutes regarding the HAI Reporting Program to reference the Oregon Health Authority instead of the Office for Oregon Health Policy and Research. The renumbering of the rules from chapter 409 to chapter 333 is a result of this legislative change. Other minor housekeeping amendments are also being made to the rules.

   In addition, the amendments update references and add two new health care acquired infections (HAIs) to the list of reportable conditions - namely, catheter-associated urinary tract infections (CAUTIs) and methicillin-resistant Staphylococcus aureus infections (MRSAs) as defined in the National Healthcare Safety Network (NHSN) Manual.

Rules Coordinator: Brittany Sande—(971) 673-1291

333-018-0100

Definitions

The following definitions apply to OAR 333-018-0100 through 333-018-0145:

(1) “ASC” means an ambulatory surgical center as defined in ORS 442.015 and that is licensed pursuant to ORS 441.015.

(2) “Authority” means the Oregon Health Authority.

(3) “CBGB” means coronary bypass graft surgery with both chest and graft incisions, as defined in the NHSN Manual.

(4) “CAUTI” means catheter-associated urinary tract infection as defined in the NHSN Manual.

(5) “CDC” means the federal Centers for Disease Control and Prevention.

(6) “CDI” means Clostridium difficile infection as defined in the NHSN Manual.

(7) “CLABSI” means central line associated bloodstream infection as defined in the NHSN Manual.

(8) “CMS” means the federal Centers for Medicare and Medicaid Services.

(9) “COLO” means colon procedures as defined in the NHSN Manual.

(10) “Committee” means the Health Care Acquired Infections Advisory Committee as defined in section 4, chapter 838, Oregon Laws 2007.

(11) “Dialysis facility” means outpatient renal dialysis facility as defined in ORS 442.015.

(12) “Follow-up” means post-discharge surveillance intended to detect CBGB, COLO, HPRO, HYST, KRPO, and LAM surgical site infection (SSI) cases occurring after a procedure.

(13) “HAI” means health care acquired infection as defined in section 2, chapter 838, Oregon Laws 2007.

(14) “Health care facility” means a facility as defined in ORS 442.015.

(15) “Hospital” means a facility as defined in ORS 442.015 and that is licensed pursuant to ORS 441.015.

(16) “Hospital Inpatient Quality Reporting Program” means the initiative administered by CMS and formerly referred to as RHQDAPU.

(17) “HPRO” means hip prosthesis procedure as defined in the NHSN Manual.

(18) “HYST” means abdominal hysterectomy procedure as defined in the NHSN Manual.

(19) “ICU” means an intensive care unit as defined in the NHSN Manual.

(20) “KPRO” means knee prosthesis procedure as defined in the NHSN Manual.

(21) “Lab ID” means laboratory-identified event as defined in the NHSN Manual.

(22) “LAM” means laminectomy procedure as defined in the NHSN Manual.

(23) “LTC facility” means long term care facility as defined in ORS 442.015.

(24) “MDS” mean the Centers for Medicare and Medicaid Services’ minimum data set nursing home resident assessment and screening tool, version 2.0 or its successor, including but not limited to manuals, forms, software, and databases.

(25) “Medical ICU” means a non-specialty intensive care unit in which at least 80 percent of patients served are adult medical patients.

(26) “Medical/Surgical ICU” means a non-specialty intensive care unit in which less than 80 percent of patients served are adult medical, adult surgical, or specialty patients.

(27) “MRSA” means methicillin-resistant Staphylococcus aureus as defined in the NHSN Manual.

(28) “NHSN” means the CDC’s National Healthcare Safety Network.

(29) “NHSN Inpatient” means a patient whose date of admission to the healthcare facility and the date of discharge are different days as defined in the NHSN Manual.

(30) “NHSN Manual” means the Patient Safety Component Protocol of the NHSN manual, version January 2013.

(31) “NICU” means a specialty intensive care unit that cares for neonatal patients.

(32) “Oregon HAI group” means the NHSN group administered by the Authority.

(33) “Overall-facility wide” means data are collected for the entire facility as defined in the NHSN Manual.

(34) “Patient information” means individually identifiable health information as defined in ORS 179.505.

(35) “Person” has the meaning given that term in ORS 442.015.

(36) “Procedure” means an NHSN operative procedure as defined in the NHSN Manual.

(37) “Provider” means health care services provider as defined in ORS 179.505.

(38) “QIO” means the quality improvement organization designated by CMS for Oregon.

(39) “RHQDAPU” means the Reporting Hospital Quality Data for Annual Payment Update initiative administered by CMS.

(40) “SCIP” means the Surgical Care Improvement Project.

(41) “SCIP-Inf-1” means the HAI process measure published by SCIP defined as prophylactic antibiotic received within one hour prior to surgical incision.

(42) “SCIP-Inf-2” means the HAI process measure published by SCIP defined as prophylactic antibiotic selection for surgical patients.

(43) “SCIP-Inf-3” means the HAI process measure published by SCIP defined as prophylactic antibiotics discontinued within 24 hours after surgery end time (48 hours for cardiac patients).

(44) “SCIP-Inf-4” means the HAI process measure published by SCIP defined as cardiac surgery patients with controlled 6 a.m. postoperative serum glucose.

(45) “SCIP-Inf-6” means the HAI process measure published by SCIP defined as surgery patients with appropriate hair removal.

(46) “SCIP-Inf-9” means urinary catheter removed on postoperative day 1 or postoperative day 2 with day of surgery being day zero.

(47) “SCIP-Inf-10” means the HAI process measure published by SCIP defined as surgery patients with perioperative temperature management.

(48) “Specialty ICU” means an intensive care unit in which at least 80 percent of adult patients served are specialty patients, including but not limited to oncology, trauma, and neurology.

(49) “SSI” means a surgical site infection event as defined in the Patient Safety Component Protocol of the NHSN manual, version January 2013.

(50) “Staff” means any employee of a health care facility or any person contracted to work within a health care facility.

(51) “State agency” has the meaning given that term in ORS 192.410.

(52) “Surgical ICU” means a non-specialty intensive care unit in which at least 80 percent of patients served are adult surgical patients.

Stat. Auth.: ORS 442.420 & OL 2007, Ch. 838 ¦ 1-6 & 12

Stats. Implemented: ORS 179.505, 192.410, 192.496, 192.502, 441.015, 442.011, 442.400, 442.405, & OL 2007, Ch. 838 ¦ 1-6 &12

Hist.: OHP 1-2008, f. & cert. ef. 7-1-08; OHP 1-2009, f. & cert. ef. 7-1-09; OHP 4-2010, f. 6-30-10, cert. ef. 7-1-10; OHP 4-2011(Temp), f. 7-28-11, cert. ef. 8-1-11 thru 1-25-12; OHP 7-2011, f. 9-30-11, cert. ef. 10-1-11; Renumbered from 409-023-0000 by PH 13-2013, f. 12-26-13, cert. ef. 1-1-14

333-018-0105

Review

Unless otherwise directed by the Authority, the committee shall review these rules (OAR 333-018-0100 through 333-018-0145) at least biennially.

Stat. Auth.: ORS 442.420 & 2007 OL Ch. 838 ¦ 1–6 & 12

Stats. Implemented: 2007 OL Ch. 838 ¦ 1–6 & 12

Hist.: OHP 1-2008, f. & cert. ef. 7-1-08; Renumbered from 409-023-0005 by PH 13-2013, f. 12-26-13, cert. ef. 1-1-14

333-018-0110

HAI Reporting for Hospitals

(1) All hospitals shall collect data for HAI outcome and process measures for the HAI reporting program in accordance with these rules, except:

(a) Hospitals shall report facility-wide inpatient MRSA bacteremia data using the Lab-ID method for MRSA bacteremia in the NHSN MDRO and CDI Module protocol for services provided in hospitals on or after January 1, 2014.

(b) Hospitals shall report NHSN inpatient CAUTI events in adult and pediatric ICUs for services provided on or after January 1, 2014.

(2) Reportable HAI outcome measures are:

(a) SSIs for NHSN Inpatient CBGB, COLO, HPRO, HYST, KPRO, and LAM procedures.

(b) CLABSI in medical ICUs, surgical ICUs, and combined medical/surgical ICUs.

(c) NHSN Inpatient CDI facility-wide.

(d) NHSN Inpatient MRSA bacteremia facility-wide.

(e) CAUTI in adult and pediatric ICUs.

(3) The infection control professional (ICP), as defined by the facility, shall actively seek out infections defined in subsections (2)(a) and (e) of this rule during a patient’s stay by screening a variety of data that may include but is not limited to:

(a) Laboratory;

(b) Pharmacy;

(c) Admission;

(d) Discharge;

(e) Transfer;

(f) Radiology;

(g) Imaging;

(h) Pathology; and

(i) Patient charts, including history and physical notes, nurses and physicians notes, and temperature charts.

(4) The ICP shall use follow-up surveillance methods to detect SSIs for procedures defined in subsection (2)(a) of this rule using at least one of the following:

(a) Direct examination of patients’ wounds during follow-up visits to either surgery clinics or physicians’ offices;

(b) Review of medical records, subsequent hospitalization records, or surgery clinic records;

(c) Surgeon surveys by mail or telephone;

(d) Patient surveys by mail or telephone; or

(e) Other facility surveys by mail or telephone.

(5) Others employed by the facility may be trained to screen data sources for these infections, but the ICP must determine that the infection meets the criteria established by these rules.

(6) The HAI reporting system for HAI outcome measures shall be NHSN. Each Oregon hospital shall comply with processes and methods prescribed by CDC for NHSN data submission. These include but are not limited to definitions, data collection, data reporting, and administrative and training requirements. Each Oregon hospital shall:

(a) Join the Oregon HAI group in NHSN.

(b) Authorize disclosure of NHSN data to the Authority as necessary for compliance with these rules, including but not limited to summary data and denominator data for all SSIs, the annual hospital survey and data analysis components for all SSIs, and summary data and denominator data for all medical ICUs, surgical ICUs, and combined medical/surgical ICUs.

(c) Report its data for outcome measures to NHSN no later than 30 days after the end of the collection month. The NHSN field “Discharge Date” is mandatory for all outcome measures.

(7) Each hospital shall report on a quarterly basis according to OAR 333-018-0110(1) the following HAI process measures:

(a) SCIP-Inf-1;

(b) SCIP-Inf-2;

(c) SCIP-Inf-3;

(d) SCIP-Inf-4;

(e) SCIP-Inf-6;

(f) SCIP-Inf-9; and

(g) SCIP-Inf-10.

(8) The reporting system for HAI process measures shall be the Hospital Inpatient Quality Reporting Program, formerly referred to as the RHQDAPU program as configured on July 1, 2008. Each Oregon hospital shall:

(a) Comply with reporting processes and methods prescribed by CMS for the RHQDAPU program. These include but are not limited to definitions, data collection, data reporting, and administrative and training requirements; and

(b) Report data quarterly for HAI process measures. Data must be submitted to and successfully accepted into the QIO clinical warehouse no later than 11:59 p.m. central time, on the 15th calendar day, four months after the end of the quarter.

(9) For NICUs, the HAI reporting system for outcome measures shall be NHSN. Each Oregon hospital with a NICU shall comply with processes and methods prescribed by NHSN for the CLABSI reporting, including but not limited to definitions, data collection, data submission, and administrative and training requirements. Each Oregon hospital shall:

(a) Authorize disclosure of NHSN data to the Authority as necessary for compliance with these rules, including but not limited to facility identifiers.

(b) Submit NICU data to NHSN according to the NHSN Manual.

(10) Each hospital shall complete an annual survey, as defined by the Authority, of influenza vaccination of staff and submit the completed survey to the Authority. The survey shall include but not be limited to the following questions regarding influenza vaccine coverage of facility staff:

(a) Number of staff with a documented influenza vaccination during the previous influenza season;

(b) Number of staff with a documented medical contraindication to influenza vaccination during the previous influenza season;

(c) Number of staff with a documented refusal of influenza vaccination during the previous influenza season; and

(d) Facility assessment of influenza vaccine coverage of facility staff during the previous influenza season and plans to improve vaccine coverage of facility staff during the upcoming influenza season.

Stat. Auth.: ORS 442.420 & 2007 OL Ch. 838 ¦ 1–6 & 12

Stats. Implemented: ORS 442.405 & 2007 OL Ch. 838 ¦ 1–6 & 12

Hist.: OHP 1-2008, f. & cert. ef. 7-1-08; OHP 1-2009, f. & cert. ef. 7-1-09; OHP 4-2010, f. 6-30-10, cert. ef. 7-1-10; OHP 4-2011(Temp), f. 7-28-11, cert. ef. 8-1-11 thru 1-25-12; OHP 7-2011, f. 9-30-11, cert. ef. 10-1-11; Renumbered from 409-023-0010 by PH 13-2013, f. 12-26-13, cert. ef. 1-1-14

333-018-0115

HAI Reporting for Ambulatory Surgery Centers

(1) Each ASC shall complete a survey of evidenced-based elements of patient safety performance as defined by the Authority.

(2) The survey shall be submitted annually by each ASC to the Authority no later than 30 days after receipt of the survey.

(3) Each ASC shall complete an annual survey, as defined by the Authority, of influenza vaccination of staff and submit the completed survey to the Authority. The survey shall include but not be limited to the following questions regarding influenza vaccine coverage of facility staff:

(a) Number of staff with a documented influenza vaccination during the previous influenza season;

(b) Number of staff with a documented medical contraindication to influenza vaccination during the previous influenza season;

(c) Number of staff with a documented refusal of influenza vaccination during the previous influenza season; and

(d) Facility assessment of influenza vaccine coverage of facility staff during the previous influenza season and plans to improve vaccine coverage of facility staff during the upcoming influenza season.

Stat. Auth.: ORS 442.420 & OL 2007, Ch. 838 ¦ 1-6 and 12

Stats. Implemented: ORS 442.405 & OL 2007, Ch. 838 ¦ 1-6 and 12

Hist.: OHP 1-2009, f. & cert. ef. 7-1-09; OHP 4-2011(Temp), f. 7-28-11, cert. ef. 8-1-11 thru 1-25-12; OHP 7-2011, f. 9-30-11, cert. ef. 10-1-11; Renumbered from 409-023-0012 by PH 13-2013, f. 12-26-13, cert. ef. 1-1-14

333-018-0120

HAI Reporting for Long Term Care Facilities

(1) The HAI Reporting System for outcome measures shall be MDS.

(2) Reportable HAI outcome measures are from MDS and include the data element, “urinary tract infection in the last 30 days.”

(3) Each LTC facility shall comply with reporting processes and methods prescribed by CMS for MDS. These include but are not limited to definitions, data collection, data submission, and administrative and training requirements.

(4) Each LTC facility shall complete an annual survey, as defined by the Authority, of influenza vaccination of staff and submit the completed survey to the Authority. The survey shall include but not be limited to the following questions regarding influenza vaccine coverage of facility staff:

(a) Number of staff with a documented influenza vaccination during the previous influenza season;

(b) Number of staff with a documented medical contraindication to influenza vaccination during the previous influenza season;

(c) Number of staff with a documented refusal of influenza vaccination during the previous influenza season; and

(d) Facility assessment of influenza vaccine coverage of facility staff and volunteers during the previous influenza season and plans to improve vaccine coverage of facility staff during the upcoming influenza season.

Stat. Auth.: ORS 442.420 & 2007 OL Ch. 838 ¦ 1–6 & 12

Stats. Implemented: ORS 442.405 & 2007 OL Ch. 838 ¦ 1–6 & 12

Hist.: OHP 1-2009, f. & cert. ef. 7-1-09; Renumbered from 409-023-0013 by PH 13-2013, f. 12-26-13, cert. ef. 1-1-14

333-018-0125

HAI Reporting for Other Health Care Facilities

Dialysis facilities shall submit data for the HAI reporting program for services provided on or after January 1, 2013 Dialysis facilities that report events data to the Centers for Medicare and Medicaid (CMS) shall be considered to comply with HAI reporting requirements if these dialysis facilities provide the same data to the Authority, or permits the Authority to have access to the same data, as is reported to CMS.

Stat. Auth.: ORS 442.420 & OL 2007, Ch. 838 ¦ 1-6 and 12

Stats. Implemented: ORS 442.405 & OL 2007, Ch. 838 ¦ 1-6 and 12

Hist.: OHP 1-2008, f. & cert. ef. 7-1-08; OHP 1-2009, f. & cert. ef. 7-1-09; OHP 4-2011(Temp), f. 7-28-11, cert. ef. 8-1-11 thru 1-25-12; OHP 7-2011, f. 9-30-11, cert. ef. 10-1-11; Renumbered from 409-023-0015 by PH 13-2013, f. 12-26-13, cert. ef. 1-1-14

333-018-0130

HAI Public Disclosure

(1) The Authority shall disclose to the public updated facility-level and state-level HAI rates at least quarterly.

(2) The Authority may disclose state-level and facility-level HAI data, including but not limited to observed frequencies, expected frequencies, proportions, and ratios.

(3) The Authority shall summarize HAI data by facilities subject to this reporting in an annual report. The Authority shall publish the annual report no later than April 30 of each calendar year.

(4) The Authority shall disclose data and accompanying explanatory documentation in a format that facilitates access and use by the general public and health care providers.

(5) The Authority may use statistically valid methods to make comparisons by facility, and to state, regional, and national statistics.

(6) The Authority shall provide a maximum of 30 calendar days for facilities to review facility-reported data prior to public release of data.

(7) The Authority shall provide facilities the opportunity to submit written comments and may include any submitted information in the annual report.

(8) Pending recommendations from the committee, the Authority may publish additional reports intended to serve the public’s interest.

Stat. Auth.: ORS 442.420 & 2007 OL Ch. 838 ¦ 1–6 & 12

Stats. Implemented: ORS 442.405, 192.496, 192.502, 192.243, 192.245 & 2007 OL Ch. 838 ¦ 1–6 & 12

Hist.: OHP 1-2008, f. & cert. ef. 7-1-08; Renumbered from 409-023-0020 by PH 13-2013, f. 12-26-13, cert. ef. 1-1-14

333-018-0135

HAI Data Processing and Security

(1) The Authority shall obtain hospital outcome measure data files directly from NHSN at least quarterly.

(2) The Authority shall obtain hospital process measure data files from the CMS hospital compare website at least quarterly.

(3) The Authority shall calculate state-level and facility-level statistics to facilitate HAI public disclosure. These statistics may include but are not limited to observed frequencies, expected frequencies, proportions, rates, and ratios. The Authority shall make public the methods used to calculate statistics and perform comparisons.

(4) The Authority shall use statistically valid risk adjustment methods recommended by the committee including but not limited to NHSN methodology.

(5) The Authority shall undertake precautions to prevent unauthorized disclosure of the raw data files. These precautions include but are not limited to:

(a) Storing the raw data files on the internal storage hardware of a password-protected personal computer that is physically located within the Authority;

(b) Restricting staff access to the raw data files;

(c) Restricting network access to the raw data files; and

(d) If applicable, storing patient information within a strongly-encrypted and password-protected virtual drive or using other methods to reliably achieve the same level of security.

Stat. Auth.: ORS 442.420 & 2007 OL Ch. 838 ¦ 1–6 & 12

Stats. Implemented: ORS 192.496, 192.502 & 2007 OL Ch. 838 ¦ 1–6 & 12

Hist.: OHP 1-2008, f. & cert. ef. 7-1-08; Renumbered from 409-023-0025 by PH 13-2013, f. 12-26-13, cert. ef. 1-1-14

333-018-0140

Prohibited Activities

Unless specifically required by state or federal rules, regulations, or statutes, the Authority is prohibited from:

(1) Disclosing individually identifiable patient, health care professional, or health care facility employee information;

(2) Intentionally linking or attempting to link individual providers to individual HAI events; and

(3) Providing patient-level or provider-level reportable HAI data to any state agency for enforcement or regulatory actions.

Stat. Auth.: ORS 442.420 & 2007 OL Ch. 838 ¦ 1–6 & 12

Stats. Implemented: ORS 192.496, 192.502 & 2007 OL Ch. 838 ¦ 1–6 & 12

Hist.: OHP 1-2008, f. & cert. ef. 7-1-08; Renumbered from 409-023-0030 by PH 13-2013, f. 12-26-13, cert. ef. 1-1-14

333-018-0145

Compliance

(1) Health care facilities that fail to comply with these rules or fail to submit required data shall be subject to civil penalties not to exceed $500 per day per violation.

(2) The Authority shall annually evaluate the quality of data submitted, as recommended by the committee.

Stat. Auth.: ORS 442.445 & 442.420

Stats. Implemented: ORS 442.445

Hist.: OHP 1-2008, f. & cert. ef. 7-1-08; Renumbered from 409-023-0035 by PH 13-2013, f. 12-26-13, cert. ef. 1-1-14


Rule Caption: Edits, amendments, and adoption of rules related to Radiation Protection Services

Adm. Order No.: PH 14-2013

Filed with Sec. of State: 12-26-2013

Certified to be Effective: 1-1-14

Notice Publication Date: 11-1-2013

Rules Adopted: 333-106-0735

Rules Amended: 333-116-0660, 333-116-0680, 333-116-0683, 333-116-0687, 333-116-0690, 333-116-0700, 333-116-0715, 333-118-0040, 333-119-0010, 333-119-0090, 333-119-0110

Subject: The Oregon Health Authority, Public Health Division, Center for Health Protection is permanently amending and adopting Oregon Administrative Rules related to the programs within the Radiation Protection Services.

   The Radiation Materials Licensing program is amending rules to comply with the Nuclear Regulatory Commission’s (NRC) 10 CFR Parts 1-50 by correcting rule cross referencing pertaining to the training requirements for the medical use of radioactive materials. OAR 333-118-0040 is being revised to correct an omission within the rule allowing physicians to transport radioactive materials. Rule amendments do not impact current practices, but provides for clarity regarding rule referencing.

   The X-ray program is adopting rules relating to the passage of Senate Bill 420 by the 2013 Legislative Assembly which requires facilities that perform mammography to notify the patient and healthcare provider if results identify the presence of dense breast tissue and to inform the patient of the possibility of unrecognized breast cancer. The rule also recommends the appropriateness of supplemental testing.

   The Tanning program is adopting rules relating to the passage of House Bill 2896 by the 2013 Legislative Assembly. House Bill 2896 prohibits tanning facilities from allowing a person who is under 18 years of age to use a tanning device owned or operated by the facility except as directed by a licensed physician and to post a notice in a conspicuous space that communicates that persons under the age of 18 are not allowed to use a tanning device.

Rules Coordinator: Brittany Sande—(971) 673-1291

333-106-0735

Breast Density Notification

(1) As used in this rule:

(a) “Breast Density” refers to the relative amount of different tissues present in the breast. A dense breast has less fat than glandular and connective tissue. Mammogram films of breasts with higher density are harder to read and interpret than those of less dense breasts. (Source: National Cancer Institute).

(b) “Facility” has the meaning given that term in 42 U.S.C. 263b and includes but is not limited to a hospital, outpatient department, clinic, radiology practice, or mobile unit, an office of a physician, or other facility that conducts breast cancer screening or diagnosis through mammography activities. “Facility” does not include a facility of the Department of Veterans Affairs.

(c) “Mammography activities” means the operation of equipment to produce a mammogram, the processing of the film, the initial interpretation of the mammogram and the viewing conditions for that interpretation.

(2) In all cases where a mammogram shows a patient has extreme breast density, the facility shall incorporate the following notification within the lay summary mammography report provided to the patient. When a mammogram shows a patient has heterogeneous breast density, the decision of whether or not to incorporate the patient notification is left to the interpreting radiologist’s discretion:

DENSE BREAST TISSUE NOTIFICATION

Your mammogram shows that your breast tissue is dense. For most women, breast density decreases with age, but in some women, there is little change. Dense breast tissue is common and is not abnormal. However, dense breast tissue can make it harder to find cancer on a mammogram and may also be associated with an increased risk of breast cancer. This information is provided to you by Oregon State Law to raise your awareness and to promote discussion with your health care provider about your own risk for breast cancer. Together, you can decide if additional breast imaging tests such as a breast ultrasound, Magnetic Resonance Imaging (MRI) or Breast-Specific-Gamma-Imaging (BSGI) would be beneficial based on your risk factors and physical examinations. A report of your results was sent to your health care provider.

(3) The Dense Breast Tissue Notification statement and guidelines shall be included in the facility’s policy on how they communicate mammography results to the patient and their health care providers.

Stat. Auth.: ORS 413.042 & 2013 OL Ch. 411

Stats. Implemented: 2013 OL Ch. 411

Hist.: PH 14-2013, f. 12-26-13, cert. ef. 1-1-14

333-116-0660

Training for Uptake, Dilution or Excretion Studies

Except as provided in OAR 333-116-0740, the licensee shall require the authorized user of a radiopharmaceutical listed in 333-116-0300 to be a physician who:

(1) Is certified by a medical specialty board whose certification process has been recognized by the Nuclear Regulatory Commission or an Agreement State and who meets the requirements in section (4) of this rule (The names of board certifications recognized by the NRC or an Agreement State are posted on the NRC’s website). To have its certification process recognized, a specialty board shall require all candidates for certification to:

(a) Complete 60 hours of training and experience in basic radionuclide handling techniques applicable to the medical use of unsealed byproduct material for uptake, dilution, and excretion studies. The training and experience must include paragraphs (3)(a)(A) through (3)(b)(F) of this rule; and

(b) Pass an examination administered by diplomats of the specialty board that assesses knowledge and competence in radiation safety, radionuclide handling and quality control; or

(2) Is an authorized user under OAR 333-116-0670, 333-116-0680, or equivalent Nuclear Regulatory Commission or Agreement State requirements; or

(3) Has completed 60 hours of training and experience, including a minimum of eight hours of classroom and laboratory training, in basic radionuclide handling techniques and radiation safety applicable to the medical use of unsealed byproduct material for uptake, dilution, and excretion studies. The training and experience must include:

(a) Classroom and laboratory training in the following areas:

(A) Radiation physics and instrumentation;

(B) Radiation protection;

(C) Mathematics pertaining to the use and measurement of radioactivity;

(D) Chemistry of byproduct material for medical use; and

(E) Radiation biology; and

(b) Work experience, under the supervision of an authorized user who meets the requirements in OAR 333-116-0660, 333-116-0670, 333-116-0680 and 333-116-0740 or Nuclear Regulatory Commission or equivalent Agreement State requirements, involving:

(A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

(B) Performing quality control procedures on instruments used to determine the activity of dosages and performing checks for proper operation of survey meters;

(C) Calculating, measuring and safely preparing patient or human research subject dosages;

(D) Using administrative controls to prevent a medical event involving the use of unsealed byproduct material;

(E) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures; and

(F) Administering dosages of radiopharmaceutical drugs to patients or human research subjects; and

(4) Has obtained written attestation, signed by a preceptor authorized user who meets the requirements, in OAR 333-116-0740, 333-116-0660, 333-116-0670, or 333-116-0680, or Nuclear Regulatory Commission or equivalent Agreement State requirements, that the individual has satisfactorily completed the requirements in subsection (1)(a) or section (3) of this rule and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under 333-116-0300.

Stat. Auth.: ORS 453.635

Stats. Implemented: ORS 453.605 - 453.807

Hist.: HD 1-1991, f. & cert. ef. 1-8-91; PH 3-2003, f. & cert. ef. 3-27-03; PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05; PH 36-2004, f. & cert. ef. 12-1-04; PH 5-2005, f. & cert. ef. 4-11-05; PH 12-2006, f. & cert. ef. 6-16-06; PH 4-2007, f. & cert. ef. 3-1-07; PH 14-2008, f. & cert. ef. 9-15-08; PH 4-2010, f. & cert. ef. 2-16-10; PH 10-2011, f. 9-30-11, cert. ef. 10-1-11; PH 4-2013, f. & cert. ef. 1-29-13; PH 14-2013, f. 12-26-13, cert. ef. 1-1-14

333-116-0680

Training for Therapeutic Use of Radiopharmaceuticals

Except as provided in OAR 333-116-0740, the licensee must require an authorized user of unsealed byproduct material for the uses authorized under 333-116-0360 to be a physician who:

(1) Is certified by a medical specialty board whose certification process has been recognized by the Commission or an Agreement State and who meets the requirements in paragraph (2)(b)(F) and subparagraph (2)(b)(F)(ii) of this rule. (Specialty boards whose certification processes have been recognized by the Nuclear Regulatory Commission or an Agreement State will be posted on the Nuclear Regulatory Commission’s webpage). To be recognized, a specialty board shall require all candidates for certification to:

(a) Successfully complete residency training in a radiation therapy or nuclear medicine training program or a program in a related medical specialty. These residency training programs must include 700 hours of training and experience as described in section (2) and subsection (2)(b). Eligible training programs must be approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education, the Royal College of Physicians and Surgeons of Canada, or the Committee on Post-Graduate Training of the American Osteopathic Association; and

(b) Pass an examination, administered by diplomats of the specialty board, which tests knowledge and competence in radiation safety, radionuclide handling, quality assurance, and clinical use of unsealed byproduct material for which a written directive is required; or

(2) Has completed 700 hours of training and experience, including a minimum of 200 hours of classroom and laboratory training in basic radionuclide handling techniques applicable to the medical use of unsealed byproduct material requiring a written directive. The training and experience must include:

(a) Classroom and laboratory training in the following areas:

(A) Radiation physics and instrumentation;

(B) Radiation protection;

(C) Mathematics pertaining to the use and measurement of radioactivity;

(D) Chemistry of byproduct material for medical use; and

(E) Radiation biology; and

(b) Work experience, under the supervision of an authorized user who meets the requirements in OAR 333-116-0740, and sections (1) and (2) of this rule, or Nuclear Regulatory Commission or equivalent Agreement State requirements. A supervising authorized user, who meets the requirements in section (2) of this rule, must have experience in administering dosages in the same dosage category or categories as given in 333-116-0680(2)(b)(F) as the individual requesting authorized user status. The work experience must involve:

(A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

(B) Performing quality control procedures on instruments used to determine the activity of dosages, and performing checks for proper operation of survey instruments;

(C) Calculating, measuring, and safely preparing patient or human research subject dosages;

(D) Using administrative controls to prevent a medical event involving the use of unsealed byproduct material;

(E) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures; and

(F) Administering dosages of radiopharmaceutical drugs to patients or human research subjects involving a minimum of three cases in each of the following categories for which the individual is requesting authorized user status:

(i) Oral administration of less than or equal to 1.22 Gigabecquerels (33 millicuries) of sodium iodide I-131;

(ii) Oral administration of greater than 1.22 Gigabecquerels (33 millicuries) of sodium iodide I-131;

NOTE: Experience with at least three cases in Category (vii)(2) also satisfies the requirement in Category (vii)(A).

(iii) Parenteral administration of any beta emitter or a photon-emitting radionuclide with a photon energy less than 150 keV; or

(iv) Parenteral administration of any other radionuclide; and

(c) Has obtained written attestation that the individual has satisfactorily completed the requirements in sections (1) and (2) and (2)(b)(F) of this rule, and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under OAR 333-116-0360. The written attestation must be signed by a preceptor authorized user who meets the requirements in 333-116-0740, 333-116-0680 or equivalent Nuclear Regulatory Commission or Agreement State requirements. The preceptor authorized user, who meets the requirements in section (2) of this rule, must have experience in administering dosages in the same dosage category or categories as given in 333-116-0680(2)(b)(F)(i), (ii), (iii), or (iv) as the individual requesting authorized user status.

Stat. Auth.: ORS 453.635

Stats. Implemented: ORS 453.605 - 453.807

Hist.: HD 1-1991, f. & cert. ef. 1-8-91; PH 3-2003, f. & cert. ef. 3-27-03; PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05; PH 36-2004, f. & cert. ef. 12-1-04; PH 5-2005, f. & cert. ef. 4-11-05; PH 12-2006, f. & cert. ef. 6-16-06; PH 4-2007, f. & cert. ef. 3-1-07; PH 14-2008, f. & cert. ef. 9-15-08; PH 10-2011, f. 9-30-11, cert. ef. 10-1-11; PH 4-2013, f. & cert. ef. 1-29-13; PH 14-2013, f. 12-26-13, cert. ef. 1-1-14

333-116-0683

Training for the Oral Administration of Sodium Iodide I-131 Requiring a Written Directive in Quantities Less Than or Equal to 1.22 Gigabecquerels (33 millicuries)

Except as provided in OAR 333-116-0740, the licensee shall require an authorized user for the oral administration of sodium iodide I-131 requiring a written directive and the total treatment quantity is less than or equal to 1.22 Gigabecquerels (33 millicuries), to be a physician who:

(1) Is certified by a medical specialty board whose certification process includes all of the requirements in section (3) of this rule and whose certification has been recognized by the Nuclear Regulatory Commission or an Agreement State and who meets the requirements in subsection (3)(c) of this rule. (The names of board certifications which have been recognized by the Nuclear Regulatory Commission or an Agreement State are posted on the Nuclear Regulatory Commission’s webpage); or

(2) Is an authorized user under OAR 333-116-0680 for uses listed in 333-116-0680(2)(b)(F)(i) or (ii) or 333-116-0687, or equivalent Agreement State requirements; or

(3) Has successfully completed 80 hours of classroom and laboratory training, applicable to the medical use of sodium iodide I-131 for procedures requiring a written directive.

(a) The training must include:

(A) Radiation physics and instrumentation;

(B) Radiation protection;

(C) Mathematics pertaining to the use and measurement of radioactivity;

(D) Chemistry of byproduct material for medical use; and

(E) Radiation biology; and

(b) Has work experience, under the supervision of an authorized user who meets the requirements in OAR 333-116-0680, 333-116-0683, 333-116-0687, 333-116-0740 or equivalent Nuclear Regulatory Commission or Agreement State requirements. A supervising authorized user who meets the requirements in 333-116-0680(2) must have experience in administering dosages as specified in 333-116-0680(2)(b)(F)(i) or (ii). The work experience must involve:

(A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

(B) Calibrating instruments used to determine the activity of dosages and performing checks for proper operation for survey meters;

(C) Calculating, measuring, and safely preparing patient or human research subject dosages;

(D) Using administrative controls to prevent a medical event involving the use of byproduct material;

(E) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures; and

(F) Administering dosages to patients or human research subjects, that includes at least three cases involving the oral administration of less than or equal to 1.22 Gigabecquerels (33 millicuries) of sodium iodide I-131; and

(c) Has obtained written attestation that the individual has satisfactorily completed the requirements in subsections (3)(a) and (3)(b) of this rule and has achieved a level of competency sufficient to function independently as an authorized user for medical uses authorized under OAR 333-116-0360. The written attestation must be signed by a preceptor authorized user who meets the requirements in 333-116-0740, 333-116-0680, 333-116-0683, 333-116-0687 or equivalent Nuclear Regulatory Commission or Agreement State requirements. A preceptor authorized user, who meets the requirement in 333-116-0680(2), must also have experience in administering dosages as specified in 333-116-0680(2)(b)(F)(i) and (ii).

Stat. Auth.: ORS 453.635

Stats. Implemented: ORS 453.605 - 453.807

Hist.: PH 12-2006, f. & cert. ef. 6-16-06; PH 4-2007, f. & cert. ef. 3-1-07; PH 14-2008, f. & cert. ef. 9-15-08; PH 4-2010, f. & cert. ef. 2-16-10; PH 10-2011, f. 9-30-11, cert. ef. 10-1-11; PH 4-2013, f. & cert. ef. 1-29-13; PH 14-2013, f. 12-26-13, cert. ef. 1-1-14

333-116-0687

Qualifications for Authorized User for Oral Administration When a Written Directive is Required

Except as provided in OAR 333-116-0740, the licensee must require an authorized user for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 Gigabecquerels (33 millicuries), to be a physician who:

(1) Is certified by a medical specialty board whose certification process includes all of the requirements in subsection (3)(a) and (3)(b) of this rule and whose certification has been recognized by the Commission or an Agreement State, and who meets the requirements in subsection (3)(c) of this rule. (The names of board certifications which have been recognized by the Nuclear Regulatory Commission or an Agreement State are posted on the Nuclear Regulatory Commission webpage); or

(2) Is an authorized user under OAR 333-116-0680 for uses listed in 333-116-0680(2)(b)(F)(ii), or equivalent Nuclear Regulatory commission or Agreement State requirements; or

(3) Has successfully completed 80 hours of classroom and laboratory training, applicable to the medical use of sodium iodide I-131 for procedures requiring a written directive.

(a) The training must include:

(A) Radiation physics and instrumentation;

(B) Radiation protection;

(C) Mathematics pertaining to the use and measurement of radioactivity;

(D) Chemistry of byproduct material for medical use; and

(E) Radiation biology; and

(b) Has work experience, under the supervision of an authorized user who meets the requirements in OAR 333-116-0680, 333-116-0687, 333-116-0740, or equivalent Nuclear Regulatory Commission or Agreement State requirements. A supervising authorized user, who meets the requirements in 333-116-0680(2), must have experience in administering dosages as specified in 333-116-0680(2)(b)(F)(ii). The work experience must involve:

(A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

(B) Calibrating instruments used to determine the activity of dosages and performing checks for proper operation for survey meters;

(C) Calculating, measuring, and safely preparing patient or human research subject dosages;

(D) Using administrative controls to prevent a medical event involving the use of byproduct material;

(E) Using procedures to contain spilled byproduct material safely and using proper decontamination procedures; and

(F) Administering dosages to patients or human research subjects, that includes at least three cases involving the oral administration of greater than 1.22 Gigabecquerels (33 millicuries) of sodium iodide I-131; and

(c) Has obtained written attestation that the individual has satisfactorily completed the requirements in subsections (3)(a) and (3)(b) of this rule, and has achieved a level of competency sufficient to function independently as an authorized user for medical uses authorized under OAR 333-116-0360. The written attestation must be signed by a preceptor authorized user who meets the requirements in 333-116-0680, 333-116-0687, 333-116-0740, or equivalent Agreement State requirements. A preceptor authorized user, who meets the requirements in 333-116-0680(2), must have experience in administering dosages as specified in 333-116-0680(2)(b)(F)(ii).

Stat. Auth.: ORS 453.635

Stats. Implemented: ORS 453.605 - 453.807

Hist.: PH 12-2006, f. & cert. ef. 6-16-06; PH 4-2007, f. & cert. ef. 3-1-07; PH 14-2008, f. & cert. ef. 9-15-08; PH 4-2010, f. & cert. ef. 2-16-10; PH 10-2011, f. 9-30-11, cert. ef. 10-1-11; PH 4-2013, f. & cert. ef. 1-29-13; PH 14-2013, f. 12-26-13, cert. ef. 1-1-14

333-116-0690

Training for Therapeutic Use of Brachytherapy Source

Except as provided in OAR 333-116-0740, the licensee must require the authorized user using manual brachytherapy sources specified in 333-116-0420 for therapy to be a physician who:

(1) Is certified by a medical specialty board whose certification process includes all of the requirements in section (2) of this rule. (The names of board certifications which have been recognized by the Commission or an Agreement State are posted on the NRC’s webpage.) To have its certification process recognized, a specialty board shall require all candidates for certification to:

(a) Successfully complete a minimum of three years of residency training in a radiation oncology program approved by the Residency Review Committee of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Committee on Post-Graduate Training of the American Osteopathic Association; and

(b) Pass an examination, administered by diplomates of the specialty board, that tests knowledge and competence in radiation safety, radionuclide handling, treatment planning, quality assurance, and clinical use of manual brachytherapy; or

(2) Has completed a structured educational program in basic radionuclide handling techniques applicable to the use of manual brachytherapy sources that includes:

(a) 200 hours of classroom and laboratory training in the following areas:

(A) Radiation physics and instrumentation;

(B) Radiation protection;

(C) Mathematics pertaining to the use and measurement of radioactivity; and

(D) Radiation biology; and

(b) 500 hours of work experience, under the supervision of an authorized user who meets the requirements in this rule, OAR 333-116-0740 or equivalent Nuclear Regulatory Commission or Agreement State requirements at a medical institution, involving:

(A) Ordering, receiving, and unpacking radioactive materials safely and performing the related radiation surveys;

(B) Checking survey meters for proper operation;

(C) Preparing, implanting, and removing brachytherapy sources;

(D) Maintaining running inventories of material on hand;

(E) Using administrative controls to prevent a medical event involving the use of byproduct material; and

(F) Using emergency procedures to control byproduct material; and

(c) Has completed three years of supervised clinical experience in radiation oncology, under an authorized user who meets the requirements in OAR 333-116-0740, 333-116-0690, or equivalent Nuclear Regulatory Commission or Agreement State requirements, as part of a formal training program approved by the Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education, or the Royal College of Physicians and Surgeons of Canada, or the Committee on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required by paragraph (2)(b) of this rule; and

(d) Has obtained written attestation, signed by a preceptor authorized user who meets the requirements in OAR 333-116-0740, 333-116-0690, or equivalent Nuclear Regulatory Commission or Agreement State requirements, that the individual has satisfactorily completed the requirements in subsection (1)(a), or subsections (2)(a), (2)(b) and (2)(c) of this rule and has achieved a level of competency sufficient to function independently as an authorized user of manual brachytherapy sources for the medical uses authorized under 333-116-0420.

Stat. Auth.: ORS 453.635

Stats. Implemented: ORS 453.605 - 453.807

Hist.: HD 1-1991, f. & cert. ef. 1-8-91; PH 12-2006, f. & cert. ef. 6-16-06; PH 4-2007, f. & cert. ef. 3-1-07; PH 14-2008, f. & cert. ef. 9-15-08; PH 4-2010, f. & cert. ef. 2-16-10; PH 4-2013, f. & cert. ef. 1-29-13; PH 14-2013, f. 12-26-13, cert. ef. 1-1-14

333-116-0700

Training for Ophthalmic Use of Strontium-90

Except as provided in OAR 333-116-0740, the licensee must require the authorized user using only strontium-90 for ophthalmic radiotherapy to be a physician who:

(1) Is an authorized user under OAR 333-116-0690 or equivalent Nuclear Regulatory Commission or Agreement State requirements; or

(2) Has completed 24 hours of classroom and laboratory training applicable to the medical use of strontium-90 for ophthalmic radiotherapy.

(a) The training must include:

(A) Radiation physics and instrumentation;

(B) Radiation protection;

(C) Mathematics pertaining to the use and measurement of radioactivity; and

(D) Radiation biology; and

(b) Supervised clinical training in ophthalmic radiotherapy under the supervision of an authorized user at a medical institution that includes the use of strontium-90 for the ophthalmic treatment of five individuals. This supervised clinical training must involve:

(A) Examination of each individual to be treated;

(B) Calculation of the dose to be administered;

(C) Administration of the dose;

(D) Follow up and review of each individual’s case history; and

(E) Has obtained written attestation, signed by a preceptor authorized user who meets the requirements in OAR 333-116-0740, 333-116-0690, 333-116-0700, or equivalent Nuclear Regulatory Commission or Agreement State requirements, that the individual has satisfactorily completed the requirements in section (2) of this rule and has achieved a level of competency sufficient to function independently as an authorized user of strontium-90 for ophthalmic use.

Stat. Auth.: ORS 453.635

Stats. Implemented: ORS 453.605 - 453.807

Hist.: HD 1-1991, f. & cert. ef. 1-8-91; PH 12-2006, f. & cert. ef. 6-16-06; PH 4-2007, f. & cert. ef. 3-1-07; PH 14-2008, f. & cert. ef. 9-15-08; PH 4-2010, f. & cert. ef. 2-16-10; PH 4-2013, f. & cert. ef. 1-29-13; PH 14-2013, f. 12-26-13, cert. ef. 1-1-14

333-116-0715

Training for the Parenteral Administration of Unsealed Byproduct Material Requiring a Written Directive

Except as provided in OAR 333-116-0740, the licensee shall require an authorized user for the parenteral administration requiring a written directive, to be a physician who:

(1) Is an authorized user under OAR 333-116-0680 for uses listed in 333-116-0680(2)(b)(F)(iii) or 333-116-0680(2)(b)(F)(iv) or equivalent Agreement State requirements; or

(2) Is an authorized user under OAR 333-116-0690 or 333-116-0720, or equivalent Agreement State or Nuclear Regulatory Commission requirements and who meets the requirements in section (4) of this rule; or

(3) Is certified by a medical specialty board whose certification process has been recognized by the Nuclear Regulatory Commission or an Agreement State under OAR 333-116-0690 or 333-116-0720, and who meets the requirements in section (4) of this rule.

(4) Has successfully completed 80 hours of classroom and laboratory training, applicable to parenteral administrations, for which a written directive is required, of any beta emitter, or any photon-emitting radionuclide with a photon energy less than 150 keV, or parenteral administration of any other radionuclide for which a written directive is required.

(a) The training must include:

(A) Radiation physics and instrumentation;

(B) Radiation protection;

(C) Mathematics pertaining to the use and measurement of radioactivity;

(D) Chemistry of byproduct material for medical use; and

(E) Radiation biology; and

(b) Has work experience, under the supervision of an authorized user who meets the requirements in OAR 333-116-0680, 333-116-0715, 333-116-0740 or equivalent Nuclear Regulatory Commission or Agreement State requirements, in the parenteral administration, for which a written directive is required, of any beta emitter, or any photon-emitting radionuclide with a photon energy less than 150 keV, or parenteral administration of any other radionuclide for which a written directive is required. A supervising authorized user who meets the requirements in 333-116-0680 must have experience in administering dosages as specified in 333-116-0680(2)(b)(F)(iii) or 333-116-0680(2)(b)(F)(iv). The work experience must involve:

(A) Ordering, receiving, and unpacking radioactive materials safely, and performing the related radiation surveys;

(B) Performing quality control procedures on instruments used to determine the activity of dosages, and performing checks for proper operation of survey meters;

(C) Calculating, measuring, and safely preparing patient or human research subject dosages;

(D) Using administrative controls to prevent a medical event involving the use of unsealed byproduct material;

(E) Using procedures to contain spilled byproduct material safely, and using proper decontamination procedures; and

(F) Administering dosages to patients or human research subjects, that include at least three cases involving the parenteral administration, for which a written directive is required, of any beta emitter, or any photon-emitting radionuclide with a photon energy less than 150 keV and at least three cases involving the parenteral administration of any other radionuclide, for which a written directive is required; and

(c) Has obtained written attestation that the individual has satisfactorily completed the requirements in sections (2) or (3) of this rule, and has achieved a level of competency sufficient to function independently as an authorized user for the parenteral administration of unsealed byproduct material requiring a written directive. The written attestation must be signed by a preceptor authorized user who meets the requirements in OAR 333-116-0680, 333-116-0715, 333-116-0740 or equivalent Agreement State requirements. A preceptor authorized user, who meets the requirements in 333-116-0680, must have experience in administering dosages as specified in 333-116-0680(2)(b)(F)(iii) or 333-116-0680(2)(b)(F)(iv).

Stat. Auth.: ORS 453.635

Stats. Implemented: ORS 453.605 - 453.807

Hist.: PH 12-2006, f. & cert. ef. 6-16-06; PH 4-2007, f. & cert. ef. 3-1-07; PH 14-2008, f. & cert. ef. 9-15-08; PH 10-2011, f. 9-30-11, cert. ef. 10-1-11; PH 4-2013, f. & cert. ef. 1-29-13; PH 14-2013, f. 12-26-13, cert. ef. 1-1-14

333-118-0040

Exemptions

(1) Common and contract carriers, freight forwarders, and warehouse workers that are subject to the requirements of the U.S. Department of Transportation in 49 CFR 170 through 189 or the U.S. Postal Service in the U.S. Postal Service Manual Domestic Mail Manual, (DMM), section C-023.9.0 are exempt from the rules in chapter 333, divisions 102, 105, 113, 115, 116, 117, and 121 and the requirements for a license to the extent that they transport or store radioactive material in the regular course of their carriage for others or storage incident thereto. Common and contract carriers who are not subject to the requirements of the U.S. Department of Transportation or U.S. Postal Service are subject to OAR 333-118-0030 and other applicable requirements of these rules.

(2) Any licensee is exempt from the requirements of this division to the extent that the licensee delivers to a carrier for transport a package containing radioactive material having a specific activity not greater than (0.002 microcurie per gram 70 Becquerels per gram (Bq/g).

(3) Any physician licensed under division 116 or by an Agreement State or the Nuclear Regulatory Commission to dispense radiopharmaceuticals in the practice of medicine, is exempt from OAR 333-118-0050 with respect to transporting licensed material for use in the practice of medicine.

Stat. Auth.: ORS 453.635

Stats. Implemented: ORS 453.605 - 453.807

Hist.: HD 1-1991, f. & cert. ef. 1-8-91; PH 3-2003, f. & cert. ef. 3-27-03; PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05; PH 36-2004, f. & cert. ef. 12-1-04; PH 4-2007, f. & cert. ef. 3-1-07; PH 14-2013, f. 12-26-13, cert. ef. 1-1-14

333-119-0010

Definitions

(1) “Authority” means the Oregon Health Authority.

(2) “Customer” means any member of the public who is provided access to a tanning device in exchange for a fee or other compensation, or any individual who, in exchange for a fee or other compensation, is afforded use of a tanning device as a condition or benefit of membership or access.

(3) “Employee” means any individual, including a minor whether lawfully or unlawfully employed, who engages to furnish services for remuneration, financial or otherwise, subject to the direction and control of an employer and includes any individual who is required to have workers’ compensation coverage.

(4) “EPA” means the U.S. Environmental Protection Agency.

(5) “FDA” means the U.S. Food and Drug Administration.

(6) “Formal Training” means a course of instruction reviewed and approved by the Authority and which is conducted or presented under formal classroom conditions or online by a qualified expert possessing adequate knowledge and experience to offer a curriculum, associated training, and certification testing pertaining to and associated with the correct use of tanning equipment. Operator training shall cover ultraviolet radiation and effects on the skin, photosensitivity, FDA and State of Oregon regulations, eye protection, and equipment maintenance.

(7) “Handrails” means a suitable physical aid that will help to maintain proper exposure distance.

(8) “Identification” means:

(a) A government-issued photo identification that displays the individual’s date of birth; or

(b) A government or non-government issued photo identification when submitted with a completed Oregon Underage Tanning Medical Recommendation form.

(9) “Individual” means any human being.

(10) “Minor” means any individual under the age of 18 years old.

(11) “Operator” means the person who is an employee (defined by the Oregon Occupational Safety and Health Division, OAR 437-003-0011(2)) or contractor of the tanning facility who has received a certificate from an approved formal training course and who is responsible for:

(a) Determining customer’s skin type;

(b) Determining the suitability for use of a tanning device;

(c) Providing information regarding the dangers of ultraviolet radiation exposure including photoallergic reactions and photosensitizing agents;

(d) Assuring that all required forms are understood and properly signed by the customer;

(e) Maintaining required exposure records;

(f) Recognizing and reporting injuries or alleged injuries to the registrant;

(g) Determining the customer’s exposure schedule;

(h) Setting timers which control the duration of exposure; and

(i) Instructing the customer in the proper use of protective eyewear.

(12) “Other Compensation” means the payment or exchange of goods, services or anything of value for use of the tanning device or devices.

(13) “Person” means any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, agency, political subdivision of this state, any other state or political subdivision or agency thereof, and any legal successor, representative, agent or agency of these entities.

(14) “Phototherapy Device” means equipment that emits Ultraviolet radiation used by a health care professional in the treatment of disease or illness.

(15) “Program” means the Radiation Protection Services section of the Public Health Division.

(16) “Protective Eyewear” means suitable eyewear that protects the eye from Ultraviolet radiation and allows adequate vision.

(17) “Public Places” means the area where members of the public may assemble and are not directly affected by tanning operations.

(18) “Recommendation” means a written directive using a form provided by the Authority and signed by a licensed physician.

(19) “Registrant” means a tanning facility registered with the Authority as required by provisions of this division.

(20) “Registration” means registration with the Authority in accordance with provisions of this division.

(21) “Safe Level” means not more than 50 colonies of microorganisms per four square inches of equipment surface.

(22) “Sanitize” means the effective bactericidal treatment of surfaces of equipment and devices by an EPA or FDA registered product that provides a sufficient concentration of chemicals, and enough time to reduce the bacterial count, including pathogens, to a safe level. Chemical germicides that are registered with EPA as hospital disinfectants when used at recommended dilutions and directions may be approved for sanitizing of tanning devices.

(23) Skin Types:

(a) “Type 1” means skin burns easily and severely (painful burn); tans little or none and peels.

(b) “Type 2” means skin burns easily and severely (painful burn); tans minimally or lightly and also peels.

(c) “Type 3” means skin burns moderately and tans about average.

(d) “Type 4” means skin burns minimally, tans easily and above average with each exposure; exhibits immediate pigment darkening reaction.

(e) “Type 5” means skin rarely burns, tans easily and substantial; always exhibits immediate pigment darkening reaction

(24) “Tanning Device” means any equipment used for tanning of the skin, that emits electromagnetic radiation with wavelengths in the air between 200 and 400 nanometers including, but not limited to, a sunlamp, Ultraviolet Lamp, tanning booth, facial unit, UVA wand, or tanning bed. “Tanning device” also means any accompanying equipment, including, but not limited to, protective eyewear, timers, ballasts, starters, lamps, reflectors, cooling fans, acrylics, comfort pillows and handrails.

(25) “Tanning Facility” means any location, place, area, structure, or business that provides persons access to any tanning device.

(26) “Timer” means a device provided to terminate the exposure at a preset time interval.

(27) “Ultraviolet Radiation” means radiation that has a wavelength between two hundred nanometers and four hundred nanometers.

Stat. Auth.: ORS 431.925 - 431.955

Stats. Implemented: ORS 431.925 - 431.955

Hist.: HD 15-1991, f. & cert. ef. 10-1-91; HD 15-1994, f. & cert. ef. 5-6-94; PH 14-2008, f. & cert. ef. 9-15-08; PH 4-2010, f. & cert. ef. 2-16-10; PH 20-2010, f. & cert. ef. 9-1-10; PH 5-2011(Temp), f. & cert. ef. 7-1-11 thru 12-27-11; PH 10-2011, f. 9-30-11, cert. ef. 10-1-11; PH 14-2013, f. 12-26-13, cert. ef. 1-1-14

333-119-0090

Protection of Consumers

The registrant shall establish and use a procedure manual that will aid in the protection of the customer to excessive or unnecessary exposure to Ultraviolet Light. This manual shall include, but not be limited to, the following instructions:

(1) Only one customer may occupy the tanning room. In the case of a customer using a tanning device who may need the aid or assistance from another person, that individual must also be provided with and wear protective eyewear.

(2) No customer under the age of 18 years shall be allowed to use a tanning device without a completed Oregon Underage Tanning Medical Recommendation form completed by a licensed physician and identification. The recommendation:

(a) Must identify the physician and client and describe the recommended tanning session frequency(s) and duration(s);

(b) Must identify dates for starting and ending of the tanning sessions; and

(c) Cannot exceed the exposure scheduled per OAR 333-119-0100(14)(b).

(3) A sign shall be posted in conspicuous view at or near the reception area with the following text in a minimum of at least 36 point type:

“PERSONS UNDER AGE 18 ARE NOT ALLOWED TO USE A TANNING DEVICE WITHOUT A WRITTEN RECOMMENDATION FROM A LICENSED PHYSICIAN”

(4) Each person using a tanning device shall be instructed by the operator on the maximum exposure time and proper exposure distance, as recommended by the manufacturer of the device. The operator shall also instruct the customer as to the location and proper operation of the tanning device’s emergency shut off switch.

(5) Infants and minors are not permitted to be in the tanning device room during exposure by parents or guardians.

(6) Tanning operators shall limit exposure time to the exposure time recommendation provided by the device manufacturer on the tanning device or in the device operating manual. The maximum exposure time recommended by the manufacturer of the device shall not be exceeded in any 24-hour period.

(7) Tanning facilities shall post the following signs visible to the customer:

(a) “In Case Of An Emergency, Dial 911”;

(b) “Oregon Radiation Protection Services at (971) 673-0490”.

(8) Tanning operators shall maintain a list of the common photosensitizing agents as provided by the Public Health Division, FDA, or other appropriate authorities, available for review by customers.

(9) Tanning facilities are prohibited from controlling the use of tanning devices solely with token timer systems or a mechanical timer system.

Stat. Auth.: ORS 431.925 - 431.955

Stats. Implemented: ORS 431.930

Hist.: HD 15-1991, f. & cert. ef. 10-1-91; HD 15-1994, f. & cert. ef. 5-6-94; PH 3-2003, f. & cert. ef. 3-27-03; PH 31-2004(Temp), f. & cert. ef. 10-8-04 thru 4-5-05; PH 36-2004, f. & cert. ef. 12-1-04; PH 14-2008, f. & cert. ef. 9-15-08; PH 4-2010, f. & cert. ef. 2-16-10; PH 10-2011, f. 9-30-11, cert. ef. 10-1-11; PH 14-2013, f. 12-26-13, cert. ef. 1-1-14

333-119-0110

Records and Reports

(1) The registrant shall maintain a record of each customer’s total number of tanning visits, dates and durations of tanning exposures.

(2) The registrants shall maintain a record of each customer’s signature and acknowledgement that they understand the potential risks involved with exposure to Ultraviolet radiation and overexposure, and that they have reviewed a photosensitizing drug list.

(3) The registrant shall maintain and have available when requested by the Authority, all completed Oregon Underage Tanning Medical Recommendation forms with copies of the identification used for each minor allowed to use a tanning device.

(4) Any tanning client who appears to be under the age of 26 years shall be required to show identification. The type of identification, identification number, client’s name, and date of birth shall be recorded by the registrant. When requested by the Authority, records shall be available for review.

(5) The registrant shall submit to the Authority a written report of injury for which medical attention was sought or obtained from the use of registered tanning devices within five working days after occurrence. The report shall include:

(a) The name, address and phone number of the affected individual;

(b) The name, location and phone number of the tanning facility involved;

(c) The nature of the actual or alleged injury; and

(d) Any other information relevant to the actual or alleged injury to include the date and duration of exposure and any documentation of medical attention sought or obtained.

(6) The registrant shall maintain records showing the results of annual timer tests.

(7) The registrant shall maintain a record of operator training as required in OAR 333-119-0080(4).

(8) The registrant shall maintain the following information for each tanning device:

(a) Manufacturer’s equipment manual and any other service related material or instruction; and

(b) The exposure schedule developed by the manufacturer; and

(c) Records of surveys, inspections, maintenance, and modifications performed on the tanning device with names of persons performing such services, the date of service, and the hour meter reading of the device serviced.

(9) Records shall be maintained showing the receipt, transfer, repair and disposal of all tanning devices and lamps.

(10) All required records shall be maintained until inspected by the Authority and shall be so filed as to be readily available for review.

Stat. Auth.: ORS 431.925 - 431.955

Stats. Implemented: ORS 431.925 - 431.955

Hist.: HD 15-1991, f. & cert. ef. 10-1-91; HD 15-1994, f. & cert. ef. 5-6-94; PH 14-2008, f. & cert. ef. 9-15-08; PH 14-2013, f. 12-26-13, cert. ef. 1-1-14


Rule Caption: Procedures and criteria for the certification, suspension and decertification of school-based health centers

Adm. Order No.: PH 15-2013

Filed with Sec. of State: 12-26-2013

Certified to be Effective: 1-1-14

Notice Publication Date: 11-1-2013

Rules Adopted: 333-028-0200, 333-028-0210, 333-028-0220, 333-028-0230, 333-028-0240, 333-028-0250

Subject: The Oregon Health Authority, Public Health Division is permanently adopting rules pertaining to the procedures and criteria for the certification, suspension and decertification of school-based health centers (SBHCs) as mandated by the passage of House Bill 2445 (OL 2013, ch. 683) by the 2013 Legislature. The rules are intended to fulfill the mandates by prescribing certification requirements used for clinics to qualify as SBHCs, the reporting requirements for SBHCs, and the process to become a certified SBHC.

Rules Coordinator: Brittany Sande—(971) 673-1291

333-028-0200

Purpose

The school-based health center (SBHC) program supports communities in promoting the health and well-being of the school-age population through the evidence-based best practice within a public health framework. These rules (OAR 333-028-0200 through 333-028-0250) establish the procedure and criteria the Oregon Health Authority shall use to certify, suspend and decertify SBHCs. Certification of a SBHC by the SBHC state program is voluntary; an operating clinic is free to choose not to participate in certification and still operate. Only certified SBHCs are eligible for funding from the Oregon Health Authority.

Stat. Auth.: 2013 OL Ch. 683

Stats. Implemented: 2013 OL Ch. 683 & ORS 413.225

Hist.: PH 15-2013, f.12-26-13, cert. ef. 1-1-14

333-028-0210

Definitions

(1) “Authority” means the Oregon Health Authority.

(2) “Certification year” means a one-year period beginning on July 1 and ending on June 30.

(3) “Electronic health record (EHR)” means an electronic record of an individual’s health-related information that conforms to nationally recognized interoperability standards and that can be created, managed and consulted by authorized clinicians and staff across more than one health care provider.

(4) “Electronic medical record (EMR)” means a digital version of a paper chart that contains all of the patient’s medical history from one practice. An EMR is mostly used by providers for diagnosis and treatment.

(5) “Program” means the Oregon Health Authority, Public Health Division, school-based health center program.

(6) “School-based health center” (SBHC) has the meaning given the term in ORS 413.225.

(7) “SBHC system” is one or more SBHCs that operate under the same sponsoring agency.

(8) “Sponsoring agency” is an entity that provides the following services for a SBHC or contracts with another entity to provide one or more of the following:

(a) Funding;

(b) Staffing;

(c) Medical oversight;

(d) Liability insurance; and

(e) Billing support.

Stat. Auth.: 2013 OL Ch. 683

Stats. Implemented: 2013 OL Ch. 683 & ORS 413.225

Hist.: PH 15-2013, f.12-26-13, cert. ef. 1-1-14

333-028-0220

Certification Requirements

In order to be certified as a SBHC, a SBHC must meet all requirements for certification in the following sections of the 2013 SBHC Standards for Certification Manual, incorporated by reference.

(1) Sponsoring agency, section B.1;

(2) Facility, section B.2;

(3) Hours of operation, section C.1;

(4) Staffing, section C.2;

(5) Eligibility for services, section C.3;

(6) Policies and procedures, section C.4;

(7) Laboratory/Diagnostic services, section D;

(8) Comprehensive Services, section E.1;

(9) Equipment, section E.2;

(10) Medication, section E.3;

(11) Data collection/reporting, section F; and

(12) Billing, section G.

[Publications: Publications referenced are available from the agency.]

Stat. Auth.: 2013 OL Ch. 683

Stats. Implemented: 2013 OL Ch. 683 & ORS 413.225

Hist.: PH 15-2013, f.12-26-13, cert. ef. 1-1-14

333-028-0230

Application and Certification Process

(1) An individual with legal authority to act on behalf of the entity that administers a SBHC may apply for certification of a SBHC by submitting a SBHC Certification Application to the Authority via electronic mail to the program’s electronic mail address posted on the program’s website or by mail to the mailing address posted on the program’s website, www.healthoregon.org/sbhc. Instructions and criteria for submitting a SBHC Certification Application is posted on the program’s website.

(2) An individual may submit an application for more than one SBHC provided that each SBHC will be administered by the same entity and each SBHC individually meets the certification requirements.

(3) The program shall review the application within 30 days of receiving the application to determine whether it is complete.

(4) If the program determines that the application is not complete, it will be returned to the applicant for completion and resubmission.

(5) If the program determines that the application is complete it will be reviewed to determine if it meets certification requirements described in OAR 333-028-0210. If the program determines that on the face of the application and in reviewing any other applicable documents that the SBHC meets the certification requirements the program shall:

(a) Inform the applicant in writing that the application has been approved;

(b) Request the applicant complete the program’s online Operational Profile forms prior to the on-site verification review; and

(c) Schedule an on-site verification review.

(6) If a SBHC does not meet certification requirements in their certification application, the Authority may choose one of the following actions:

(a) The program may deny SBHC certification if the SBHC does not meet the requirements of these rules. The program will provide the applicant with a clear description of reasons for denial based on the certification requirements in the denial letter. An applicant may request that the program reconsider the denial of SBHC certification. A request for reconsideration must be submitted in writing to the program within 90 days of the date of the denial letter and must include a detailed explanation of why the applicant believes the program’s decision is in error along with any supporting documentation. The program shall inform the applicant in writing whether it has reconsidered its decision; or

(b) The program may approve the applicant’s SBHC certification based on an agreed upon timeline for a corrective action plan for the non-compliant requirements. The site must submit a waiver to the program that includes an explanation of the non-compliant requirements, a plan for corrective action and date for meeting compliance.

(7) Once a SBHC is certified, the certification status is effective for the following certification year.

(8) A certified SBHC must renew its certification no later than October 1 each year via the program’s online Operational Profile forms in order to remain certified.

(9) The program will notify SBHCs of their certification renewal status by November 1 each year.

Stat. Auth.: 2013 OL Ch. 683

Stats. Implemented: 2013 OL Ch. 683 & ORS 413.225

Hist.: PH 15-2013, f.12-26-13, cert. ef. 1-1-14

333-028-0240

Verification

(1) The program shall conduct one on-site verification review of each approved SBHC within one year of application approval to determine compliance with SBHC certification requirements.

(2) After the initial on-site verification review, the program shall conduct an on-site verification review every two years for a representative sample of certified SBHCs in each SBHC system.

(3) A SBHC will be notified, in writing, no less than 30 days before its scheduled verification review.

(4) A SBHC must permit program staff access to the site’s place of business during the review.

(5) The verification review must include, but is not limited to:

(a) Review of documents, policies and procedures, and records;

(b) Review of electronic medical record systems, review of electronic health records systems, and review of practice management systems;

(c) Review of data reports from electronic systems or other patient registry and tracking systems;

(d) Interviews with practice management, clinical and administrative staff;

(e) On-site observation of practice staff with at a minimum two patients, with the consent of the patient; and

(f) On-site observation of patient environment and physical environment.

(6) Following a review, program staff may conduct an exit interview with SBHC representative(s). During the exit interview the program staff shall:

(a) Inform the SBHC representative(s) of the preliminary findings of the review; and

(b) Give the SBHC representatives(s) a reasonable opportunity to submit additional facts or other information to the program staff in response to the findings.

(7) Within two weeks of the on-site visit program staff must prepare and provide the SBHC with a written report of the findings from the on-site review.

(8) If no certification deficiencies are found during the review, the program shall issue written findings to the SBHC indicating no deficiencies were found.

(9) If certification deficiencies are found during the on-site review, the program may take action in compliance with OAR 333-028-0250.

(10) The program may conduct a review of a certified SBHC without prior notice of any or all selected certification requirements for compliance and perform a verification on-site review of a certified SBHC if the program is made aware of issues of compliance from any source.

(11) At any time, a SBHC may request an administrative review of compliance, which includes one on-site visit. The review will be considered a “no penalty” review with the exception of gross violation or negligence that may require site closure or temporary suspension of services.

Stat. Auth.: 2013 OL Ch. 683

Stats. Implemented: 2013 OL Ch. 683 & ORS 413.225

Hist.: PH 15-2013, f.12-26-13, cert. ef. 1-1-14

333-028-0250

Compliance

(1) A SBHC must notify the program within 20 days of any change that brings the SBHC out of compliance with the certification requirements. A SBHC must submit a waiver to the program that includes an explanation of the non-compliant requirement, a plan for corrective action and date for meeting compliance.

(2) The program will review the waiver request and inform the SBHC of approval or denial of the waiver within two weeks of submission.

(3) If the waiver is approved the SBHC must comply with certification requirements by the proposed date of compliance.

(4) If a waiver is denied; a SBHC does not come into compliance by the date of compliance stated on the waiver; or a SBHC is out of compliance with certification requirements and has not submitted a waiver, based on the program’s discretion, the program may:

(a) Require the SBHC to complete an additional waiver with an updated plan for corrective action and updated date for meeting compliance; or

(b) Require the SBHC to complete a waiver to satisfy the requirements in section (1) of this rule; or

(c) Issue a written warning with a timeline for corrective action; or

(d) Issue a letter of non-compliance with the notification of a suspension or decertification status.

(5) A SBHC that had been decertified may be reinstated after reapplying for certification.

(6) A SBHC with its certification status suspended may have its suspension lifted once the program determines that compliance with certification requirements has been achieved satisfactorily.

(7) If there are updates to the current rules that require a SBHC to make any operational changes, the program will allow the SBHC until the beginning of the next certification year or a minimum of 90 days to come into compliance.

Stat. Auth.: 2013 OL Ch. 683

Stats. Implemented: 2013 OL Ch. 683 & ORS 413.225

Hist.: PH 15-2013, f.12-26-13, cert. ef. 1-1-14


Rule Caption: New definitions and new disease reporting requirements

Adm. Order No.: PH 16-2013

Filed with Sec. of State: 12-26-2013

Certified to be Effective: 1-1-14

Notice Publication Date: 11-1-2013

Rules Adopted: 333-019-0052, 333-056-0045

Rules Amended: 333-017-0000, 333-018-0005, 333-018-0010, 333-018-0015, 333-018-0018, 333-018-0020, 333-018-0035, 333-019-0010, 333-019-0014, 333-019-0031, 333-056-0020, 333-056-0030, 333-056-0040, 333-056-0050

Rules Repealed: 333-019-0046

Subject: The Oregon Health Authority, Public Health Division is permanently amending, adopting and repealing rules in chapter 333, divisions 17, 18, 19 and 56 relating to reportable diseases and infectious waste. The changes will: add clarifying language regarding definitions in division 17; add Vibrio spp, Grimontia spp, and nontuberculous mycobacteria (NTM) to the list of reportable diseases in division 18; simplify Typhoid restrictions, add mumps to imposition of restrictions, and adopt a new rule regarding communication during patient transfer of multidrug-resistant organisms in division 19; and adopt a rule in division 56 to implement HB 2612 (Oregon Laws 2013, chapter 109), which entitles post-partum mothers, or their designees if they are incapacitated, to take their placentas with them after discharge from the health care facility wherein the mother had given birth if certain criteria are met.

Rules Coordinator: Brittany Sande—(971) 673-1291

333-017-0000

Definitions

For purposes of OAR chapter 333, divisions 17, 18, and 19, unless the context requires otherwise or a rule contains a more specific definition, the following definitions shall apply.

(1) “AIDS”: AIDS is an acronym for acquired immunodeficiency syndrome. An individual is considered to have AIDS when their illness meets criteria published in Morbidity and Mortality Weekly Report, Volume 41, Number RR-17, pages 1–4, December 18, 1992.

(2) “Animal Suspected of Having Rabies”: An animal is suspected of having rabies when:

(a) It is a dog, cat, or ferret not known to be satisfactorily vaccinated against rabies (as defined in OAR 333-019-0017), or it is any other mammal; and

(b) It exhibits one or more of the following aberrant behaviors or clinical signs: unprovoked biting of persons or other animals, paralysis or partial paralysis of limbs, marked excitation, muscle spasms, difficulty swallowing, apprehensiveness, delirium, or convulsions; and it has no other diagnosed illness that could explain the neurological signs.

(3) “Approved Fecal Specimen” means a specimen of feces from a person who has not taken any antibiotic orally or parenterally for at least 48 hours prior to the collection of the specimen. Improper storage or transportation of a specimen, or inadequate growth of the culture suggestive of recent antibiotic usage can, at the discretion of public health microbiologists, result in specimen rejection.

(4) “Authority” means the Oregon Health Authority.

(5) “Bite, Biting, Bitten”: The words bite, biting, and bitten refer to breaking of the skin by the teeth of an animal, or mouthing a fresh abrasion of the skin by an animal.

(6) “Case” means a person who has been diagnosed by a health care provider as having a particular disease, infection, or condition, or whose illness meets defining criteria published in the Authority’s Investigative Guidelines.

(7) “Child Care Facility” means any facility as defined in ORS 657A.250 where care is provided to three or more children.

(8) “Control” has the meaning given that term in ORS 433.001.

(9) “Disease outbreak” has the meaning given that term in ORS 431.260.

(10) “Enterobacteriaceae family” means the family of bacteria that includes but is not limited to the following genera and taxonomic groups:

(a) Budvicia;

(b) Buttiauxella;

(c) Cedecea;

(d) Citrobacter;

(e) Edwardsiella;

(f) Enteric Group 58;

(g) Enteric Group 59;

(h) Enteric Group 60;

(i) Enteric Group 63;

(j) Enteric Group 64;

(k) Enteric Group 68;

(l) Enteric Group 69;

(m) Enteric Group 137;

(n) Enterobacter;

(o) Escherichia;

(p) Ewingella;

(q) Hafnia;

(r) Klebsiella;

(s) Kluyvera;

(t) Leclercia;

(u) Leminorella;

(v) Moellerella;

(w) Morganella;

(x) Obesumbacterium;

(y) Pantoea;

(z) Photorhabdus;

(aa) Plesiomonas;

(bb) Pragia;

(cc) Proteus;

(dd) Providencia;

(ee) Rahnella;

(ff) Salmonella;

(gg) Serratia;

(hh) Shigella;

(ii) Tatumella;

(jj) Trabulsiella;

(kk) Xenorhabdus;

(ll) Yersinia;

(mm) Yokenella.

(11) “Food Handler” means any business owner or employee who handles food utensils or who prepares, processes, handles or serves food for people other than members of their immediate household, for example restaurant, delicatessen, and cafeteria workers, caterers, and concession stand operators.

(12) “Food Service Facility” means an establishment that processes or serves food for sale.

(13) “Health Care Facility” has the meaning given that term in ORS 442.015.

(14) “Health Care Provider” has the meaning given that term in ORS 433.443.

(15) “HIV” means the human immunodeficiency virus, the causative agent of AIDS.

(16) “HIV Test” means a Food and Drug Administration (FDA)-approved test for the presence of HIV (including RNA testing), or for antibodies or antigens that result from HIV infection, or for any other substance specifically associated with HIV infection and not with other diseases or conditions.

(17) “HIV Positive Test” means a positive result on the most definitive HIV test procedure used to test a particular individual. In the absence of the recommended confirmation tests, this means the results of the initial test done.

(18) “Lead Poisoning” means a blood lead level of least 10 micrograms per deciliter.

(19) “Licensed Laboratory” means a medical diagnostic laboratory that is inspected and licensed by the Authority or otherwise licensed according to the provisions of the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. ¦ 263a). Any laboratory operated by the U.S. Centers for Disease Control and Prevention shall also be considered a Licensed Laboratory.

(20) “Licensed Physician” means any physician who is licensed by the Oregon Medical Board or the Board of Naturopathic Medicine.

(21) “Licensed Veterinarian” means a veterinarian licensed by the Oregon Veterinary Medical Examining Board.

(22) “Local Public Health Administrator” has the meaning given that term in ORS 431.260.

(23) “Local Public Health Authority” has the meaning given that term in ORS 431.260.

(24) “Non-Susceptible to any Carbapenem Antibiotic” means the finding of any of the following:

(a) Gene sequence specific for carbapenemase;

(b) Phenotypic test (e.g., Modified Hodge) positive for production of carbapenemase; or

(c) Resistance to all third-generation cephalosporin antibiotics tested, along with any of the following elevated minimum inhibitory concentrations (MIC) for a carbapenem antibiotic:

(A) MIC for imipenem greater than or equal to 2 ?g/ml; or

(B) MIC for meropenem greater than or equal to 2 ?g/ml.

(25) “Novel Influenza” means influenza A virus that cannot be subtyped by commercially distributed assays.

(26) “Onset”: Unless otherwise qualified, onset refers to the earliest time of appearance of signs or symptoms of an illness.

(27) “Pesticide Poisoning” means illness in a human that is caused by acute or chronic exposure to:

(a) Any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest; or

(b) Any substance or mixture of substances intended for use as a plant regulator, defoliant, or desiccant as defined in ORS 634.006.

(28) “Public Health Division (Division)” means the Public Health Division within the Oregon Health Authority.

(29) “Suspected Case” means a person whose illness is thought by a health care provider to have a significant likelihood of being due to a reportable disease, infection, or condition, based on facts such as but not limited to the patient’s signs and symptoms, possible exposure to a reportable disease, laboratory findings, or the presence or absence of an alternate explanation for the illness.

(30) “Uncommon Illness of Potential Public Health Significance”: These illnesses include:

(a) Any infectious disease with potentially life-threatening consequences that is exotic to or uncommon in Oregon, for example, variola (smallpox) or viral hemorrhagic disease;

(b) Any illness related to a contaminated medical device or product; or

(c) Any acute illness suspected to be related to environmental exposure to any infectious or toxic agent or to any household product.

(31) “Veterinary Laboratory” means a laboratory whose primary function is handling and testing diagnostic specimens of animal origin.

[Publications: Publications referenced are available from the Agency.]

Stat. Auth.: ORS 413.042, 433.004, 437.010, 616.745 & 624.080

Stats. Implemented: ORS 433.004, 433.360, 437.030, 616.745 & 624.380

Hist.: HD 15-1981, f. 8-13-81, ef. 8-15-81; HD 12-1983, f. & ef. 8-1-83; HD 4-1987, f. 6-12-87, ef. 6-19-87; HD 13-1990(Temp), f. 3-25-90, cert. ef. 8-1-90; HD 5-1991, f. 5-29-91, cert. ef. 4-1-91; HD 10-1991, f. & cert. ef. 7-23-91; HD 9-1992, f. & cert. ef. 8-14-92; HD 29-1994, f. & cert. ef. 12-2-94; OHD 2-2002, f. & cert. ef. 3-4-02; PH 11-2005, f. 6-30-05, cert. ef. 7-5-05; PH 5-2010, f. & cert. ef. 3-11-10; PH 7-2011, f. & cert. ef. 8-19-11; PH 16-2013, f. 12-26-13, cert. ef. 1-1-14

333-018-0005

To Whom Reports Shall Be Made

(1) In general, if the patient is an Oregon resident, reports shall be made to the local public health administrator for the patient’s place of residence.

(2) In lieu of reporting to the local public health administrator, with the consent of the local public health administrator and the Authority, reports may be made directly to the Authority (for example, via electronic reporting).

(3) In urgent situations when local public health staff are unavailable, case reports shall be made directly to the Authority.

(4) Where the case is not an Oregon resident, reports shall be made either to the patient’s local public health authority (if the patient resides in the United States) or directly to the Authority.

(5) In lieu of reporting to the local public health administrator, with the consent of the local public health administrator, licensed laboratories shall report directly to the Authority’s HIV Program:

(a) All tests indicative of and specific for HIV infection as required by OAR 333-018-0015;

(b) All CD4+ T-lymphocyte counts; and

(c) All HIV viral load tests.

Stat. Auth.: ORS 431.110, 433.001, 433.004, 433.006

Stats. Implemented: ORS 431.110, 433.001, 433.004, 433.006, 433.106

Hist.: HD 15-1981, f. 8-13-81, ef. 8-15-81; HD 20-1985(Temp), f. & ef. 9-30-85; HD 4-1987, f. 6-12-87, ef. 6-19-87; HD 15-1988, f. 7-11-88, cert. ef. 9-1-88; HD 13-1990(Temp), f. 5-25-90, cert. ef. 8-1-90; HD 5-1991, f. 3-29-91, cert. ef. 4-1-91; HD 10-1991, f. & cert. ef. 7-23-91; HD 29-1994, f. & cert. ef. 12-2-94; OHD 22-2001, f. & cert. ef. 10-19-01; OHD 3-2002, f. & cert. ef. 3-4-02; PH 11-2005, f. 6-30-05, cert. ef. 7-5-05; PH 1-2007, f. & cert. ef. 1-16-07; PH 7-2011, f. & cert. ef. 8-19-11; PH 16-2013, f. 12-26-13, cert. ef. 1-1-14

333-018-0010

Form of the Report

(1) A health care provider required to report reportable diseases under ORS 433.004 and these rules shall submit to the local public health administrator a report that includes but is not limited to:

(a) The identity, address, and telephone number of the person reporting;

(b) The identity, address, and telephone number of the attending health care provider, or other treating health care provider if any;

(c) The name of the person affected or ill, that person’s current address, telephone number, and date of birth;

(d) The diagnosed or suspected disease, infection, or condition; and

(e) The date of illness onset.

(2) A licensed laboratory required to report reportable diseases under ORS 433.004 and these rules shall submit to the local public health administrator a report that includes but is not limited to:

(a) The name and telephone number of the reporting laboratory;

(b) The name, gender, age or date of birth, the address and county of residence of the person from whom the laboratory specimen was obtained, if known;

(c) The date the specimen was obtained;

(d) The name, address and telephone number of the health care provider of the person from whom the laboratory specimen was obtained;

(e) The name or description of the test;

(f) The test result; and

(g) Information required by the Authority’s Manual for Mandatory Electronic Laboratory Reporting, if electronic reporting is required under OAR 333-018-0013.

(3) Reportable disease reports shall be made in the following manner:

(a) Reports for diseases or suspected diseases that are immediately reportable under OAR 333-018-0015 shall be submitted orally, by telephone, with a follow-up written report via facsimile.

(b) Reports for diseases or suspected diseases that are required to be reported within one to seven days under OAR 333-018-0013 shall be submitted in writing via facsimile or by other means approved by the local public health administrator, consistent with the need for timely reporting as provided in OAR 333-018-0015.

(c) Electronically, if required by OAR 333-018-0013.

(4) If requested by a local public health administrator or the Oregon Public Health Division, health care providers and licensed laboratories shall provide additional information of relevance to the investigation or control of reportable diseases or conditions (for example, reported signs and symptoms, laboratory test results (including negative results), potential exposures, contacts, and clinical outcomes).

Stat. Auth.: ORS 413.042 & 433.004

Stats. Implemented: ORS 433.004

Hist.: HD 15-1981, f. 8-13-81, ef. 8-15-81; HD 4-1987, f. 6-12-87, ef. 6-19-87; HD 13-1990(Temp), f. 5-25-90, cert. ef. 8-1-90; HD 5-1991, f. 3-29-91, cert. ef. 4-1-91; HD 10-1991, f. & cert. ef. 7-23-91; HD 29-1994, f. & cert. ef. 12-2-94; OHD 3-2002, f. & cert. ef. 3-4-02; PH 11-2005, f. 6-30-05, cert. ef. 7-5-05; PH 5-2010, f. & cert. ef. 3-11-10; PH 7-2011, f. & cert. ef. 8-19-11; PH 16-2013, f. 12-26-13, cert. ef. 1-1-14

333-018-0015

What Is to Be Reported and When

(1) Health care providers shall report all human cases or suspected human cases of the diseases, infections, microorganisms, and conditions specified below. The timing of health care provider reports is specified to reflect the severity of the illness or condition and the potential value of rapid intervention by public health agencies.

(2) When local public health administrators cannot be reached within the specified time limits, reports shall be made directly to the Authority, which shall maintain an around-the-clock public health consultation service.

(3) Licensed laboratories shall report all test results indicative of and specific for the diseases, infections, microorganisms, and conditions specified below for humans. Such tests include but are not limited to: microbiological culture, isolation, or identification; assays for specific antibodies; and identification of specific antigens, toxins, or nucleic acid sequences.

(4) Human reportable diseases, infections, microorganisms, and conditions, and the time frames within which they must be reported are as follows:

(a) Immediately, day or night: Bacillus anthracis (anthrax); Clostridium botulinum (botulism); Corynebacterium diphtheriae (diphtheria); novel influenza; Yersinia pestis (plague); poliomyelitis; rabies (human); measles (rubeola); Severe Acute Respiratory Syndrome (SARS) and infection by SARS coronavirus; rubella; variola major (smallpox); Francisella tularensis (tularemia); Vibrio cholerae O1, O139, or toxigenic; hemorrhagic fever caused by viruses of the filovirus (e.g., Ebola, Marburg) or arenavirus (e.g., Lassa, Machupo) families; yellow fever; intoxication caused by marine microorganisms or their byproducts (for example, paralytic shellfish poisoning, domoic acid intoxication, ciguatera, scombroid); any known or suspected common-source outbreaks; any uncommon illness of potential public health significance.

(b) Within 24 hours (including weekends and holidays): Haemophilus influenzae (any invasive disease; for laboratories, any isolation or identification from a normally sterile site); Neisseria meningitidis (any invasive disease; for laboratories, any isolation or identification from a normally sterile site); pesticide poisoning.

(c) Within one local public health authority working day: Bordetella pertussis (pertussis); Borrelia (relapsing fever, Lyme disease); Brucella (brucellosis); Campylobacter (campylobacteriosis); Chlamydophila (Chlamydia) psittaci (psittacosis); Chlamydia trachomatis (chlamydiosis; lymphogranuloma venereum); Clostridium tetani (tetanus); Coxiella burnetii (Q fever); Creutzfeldt-Jakob disease and other transmissible spongiform encephalopathies; Cryptococcus (cryptococcosis), Cryptosporidium (cryptosporidiosis); Cyclospora cayetanensis (cyclosporosis); bacteria of the Enterobacteriaceae family found to be non-susceptible to third-generation cephalosporins and to carbapenem antibiotic (other than ertapenem); Escherichia coli (Shiga-toxigenic, including E. coli O157 and other serogroups); Giardia (giardiasis); Grimontia spp.; Haemophilus ducreyi (chancroid); hantavirus; hepatitis A; hepatitis B (acute or chronic infection); hepatitis C; hepatitis D (delta); hepatitis E; HIV infection (does not apply to anonymous testing) and AIDS; death of a person <18 years of age with laboratory-confirmed influenza; lead poisoning; Legionella (legionellosis); Leptospira (leptospirosis); Listeria monocytogenes (listeriosis); mumps; Mycobacterium tuberculosis and M. bovis (tuberculosis); nonrespiratory infection with nontuberculous mycobacteria; Neisseria gonorrhoeae (gonococcal infections); pelvic inflammatory disease (acute, non-gonococcal); Plasmodium (malaria); Rickettsia (all species: Rocky Mountain spotted fever, typhus, others); Salmonella (salmonellosis, including typhoid); Shigella (shigellosis); Taenia solium (including cysticercosis and undifferentiated Taenia infections); Treponema pallidum (syphilis); Trichinella (trichinosis); Vibrio spp.; Yersinia (other than pestis); any infection that is typically arthropod vector-borne (for example: babesiosis, California encephalitis, Colorado tick fever, dengue, Eastern equine encephalitis, ehrlichiosis, Heartland virus infection, Kyasanur Forest disease, St. Louis encephalitis, West Nile fever, Western equine encephalitis, etc.); a human bitten by any other mammal; and hemolytic uremic syndrome.

(d) Within seven days: Any blood lead level tests including the result.

(5) Licensed laboratories shall report, within seven days, the results of all tests of CD4+ T-lymphocyte absolute counts and the percent of total lymphocytes that are CD4 positive, and HIV nucleic acid (viral load) tests.

Stat. Auth.: ORS 413.042, 433.004 & 433.006

Stats. Implemented: ORS 433.004 & 437.010

Hist.: HD 15-1981, f. 8-13-81, ef. 8-15-81; HD 20-1985(Temp), f. & ef. 9-30-85; HD 4-1987, f. 6-12-87, ef. 6-19-87; HD 15-1988, f. 7-11-88, cert. ef. 9-1-88; HD 13-1990(Temp), f. 5-25-90, cert. ef. 8-1-90; HD 5-1991, f. 3-29-91, cert. ef. 4-1-91; HD 10-1991, f. & cert. ef. 7-23-91; HD 9-1992, f. & cert. ef. 8-14-92; HD 29-1994, f. & cert. ef. 12-2-94; OHD 22-2001, f. & cert. ef. 10-19-01; OHD 3-2002, f. & cert. ef. 3-4-02; PH 11-2005, f. 6-30-05, cert. ef. 7-5-05; PH 7-2006, f. & cert. ef. 4-17-06; PH 13-2006(Temp), f. 6-27-06, cert. ef. 7-1-06 thru 12-27-06; PH 19-2006, f. & cert. ef. 9-13-06; PH 11-2007(Temp), f. & cert. ef. 8-22-07 thru 2-18-08; PH 13-2007, f. & cert. ef. 11-7-07; PH 8-2009(Temp), f. & cert. ef. 9-1-09 thru 2-26-10; PH 5-2010, f. & cert. ef. 3-11-10; PH 7-2011, f. & cert. ef. 8-19-11; PH 16-2013, f. 12-26-13, cert. ef. 1-1-14

333-018-0018

Submission of Isolates to the Public Health Laboratory

Licensed laboratories are required to forward aliquots or subcultures of the following to the Oregon State Public Health Laboratory:

(1) Suspected Neisseria meningitidis and Haemophilus influenzae from normally sterile sites.

(2) Suspected Shiga-toxigenic Escherichia coli (STEC), including E. coli O157; Salmonella spp., Shigella spp., Vibrio spp., Grimontia spp., Listeria spp., Yersinia spp.; Mycobacterium tuberculosis and M. bovis from any source.

(3) Serum that tests positive for IgM antibody to hepatitis A virus.

(4) Serum that tests positive for IgM core antibody to hepatitis B virus.

(5) All cryptococcal isolates.

(6) All isolates of the Enterobacteriaceae family resistant to third-generation cephalosporins and non-susceptible to any carbapenem antibiotic other than ertapenem.

(7) For persons under the age of 18 who died with laboratory-confirmed influenza: respiratory specimens or viral isolates, any Staphylococcus aureus isolates, and, after consulting with the Oregon Public Health Division, autopsy specimens.

Stat. Auth.: ORS 413.042, 433.004 & 438.450

Stats. Implemented: ORS 433.004 & 438.310

Hist.: HB 248, f. 6-30-70, ef. 7-25-70; HD 28-1988, f. & cert. ef. 12-7-88; HD 20-1994, f. & cert. ef. 7-20-94; HD 6-1995, f. & cert. ef. 9-13-95; OHD 11-2001, f. & cert. ef. 5-16-01, Renumbered from 333-024-0050(5); OHD 3-2002, f. & cert. ef. 3-4-02; PH 11-2005, f. 6-30-05, cert. ef. 7-5-05; PH 28-2006, f. 11-30-06, cert. ef 12-18-06; PH 5-2010, f. & cert. ef. 3-11-10; PH 7-2011, f. & cert. ef. 8-19-11; PH 16-2013, f. 12-26-13, cert. ef. 1-1-14

333-018-0020

Reports from Local Public Health Administrators

(1) The local public health administrator shall notify the Authority immediately of any reported cases of the following diseases and conditions: anthrax, botulism (foodborne), cholera, diphtheria, marine intoxications, measles, pesticide poisoning, plague, poliomyelitis, rabies; any uncommon illness of potential public health significance; any outbreak of disease.

(2) Animal bites that have been investigated by the local public health administrator and for which testing of the biting animal for rabies has been deemed unnecessary need not be reported to the Authority.

(3) For other reportable diseases and conditions, the local public health administrator shall notify the Authority no later than the end of each business week of all cases reported during that week. Reports shall be made by means approved by the Authority and in a format approved by the Authority.

Stat. Auth.: ORS 431.110, 431.120, 433.004, 437.010, 616.010 & 624.005

Stats. Implemented: ORS 433.004 & 437.010

Hist.: HD 15-1981, f. 8-13-81, ef. 8-15-81; HD 12-1983, f. & ef. 8-1-83; HD 4-1987, f. 6-12-87, ef. 6-19-87; HD 29-1994, f. & cert. ef. 12-2-94; OHD 3-2002, f. & cert. ef. 3-4-02; PH 7-2011, f. & cert. ef. 8-19-11; PH 16-2013, f. 12-26-13, cert. ef. 1-1-14

333-018-0035

Procedures Involving Emergency Response Employees

(1) Each person or local government employing persons to render emergency care shall designate a contact person or “designated officer” to receive reports from the local public health administrator made under ORS 433.006. The employer shall assure that the designated officer has sufficient training to carry out the duties as described below, which shall include appropriate procedures for follow-up after occupational exposures to specific diseases as specified below in section (2) and section (6).

(2) Sections (3) through (5) apply only to the following subset of reportable diseases: meningococcal disease, infectious pulmonary or laryngeal tuberculosis, diphtheria, plague (Yersinia pestis), rabies, hemorrhagic fevers (for example, Lassa, Marburg, and Ebola).

(3) Health care providers and health care facilities shall, when reporting this subset of diseases, determine and include as part of their report whether or not an emergency care provider was involved in pre-hospital care for this disease.

(4) Health care providers and facilities shall report to the local public health administrator and may relay the diagnosis of these diseases directly to the emergency care providers or the designated officer specified below in section (5), but shall not disclose the identity or addresses of the person having the disease or otherwise refer specifically to the person.

(5) Upon receiving a report of a reportable disease as defined in section (2) above, the designated officer shall notify all out-of-hospital caregivers, including but not limited to: first responders, emergency medical technicians, paramedics, firefighters, law enforcement officers, corrections officers, probation officers, or other current or former personnel of the employer who may have been exposed to the reportable disease. The designated officer shall inform the personnel only of the reportable disease and the fact of possible exposure and the appropriate follow-up procedures. The designated officer shall not inform the personnel of the identity or addresses of the individual having the reportable disease or otherwise refer specifically to the individual having the reportable disease.

(6) In the event of an occupational exposure to a bloodborne pathogen as defined by ORS 433.060, the designated officer shall also assist the exposed worker as defined in ORS 433.060 in implementing the provisions of ORS 433.065 through ORS 433.080 and associated Authority rules (chapter 333, division 22). These rules include provisions for determining HIV, hepatitis B and hepatitis C status of the source patient and soliciting HIV testing after an occupational exposure.

Stat. Auth.: ORS 433.045 - 433.080 & 431.110

Stats. Implemented: ORS 433.006 & 433.065

Hist.: HD 15-1981, f. 8-13-81, ef. 8-15-81; HD 12-1983, f. & ef. 8-1-83; HD 4-1987, f. 6-12-87, ef. 6-19-87; HD 29-1994, f. & cert. ef. 12-2-94; HD 8-1997, f. & cert. ef. 6-26-97; OHD 15-2001, f. & cert. ef. 7-12-01, Renumbered from 333-018-0023; OHD 3-2002, f. & cert. ef. 3-4-02; PH 7-2011, f. & cert. ef. 8-19-11; PH 16-2013, f. 12-26-13, cert. ef. 1-1-14

333-019-0010

Imposition of Restrictions

(1) To protect the public health, persons who attend or work at schools or child care facilities or who work at health care facilities or food service facilities shall not attend or work at these facilities whilst in a communicable stage of any restrictable diseases unless authorized to do so as hereunder specified.

(2) At all such facilities, restrictable diseases include: diphtheria, measles, Salmonella enterica serotype Typhi infection, shigellosis, Shiga-toxigenic Escherichia coli (STEC) infection, hepatitis A, tuberculosis, open or draining skin lesions infected with Staphylococcus aureus or Streptococcus pyogenes, and any illness accompanied by diarrhea or vomiting.

(3) At schools, child care, and health care facilities, such restrictable diseases shall also include: chickenpox, mumps, pertussis, rubella, and scabies. Children in the communicable stages of hepatitis B infection may be excluded from attending school or child care if, in the opinion of the local health officer, the child poses an unusually high risk to other children (for example, exhibits uncontrollable biting or spitting).

(4) At the discretion of local school authorities or the local public health authority, pediculosis may be considered a school-restrictable condition.

(5) Nothing in these rules prohibits the adoption of more stringent rules regarding exclusion from schools or child care facilities. Such additional restrictions shall require formal certification that the disease or condition in question presents a significant public health risk in that setting. For schools, this action may be taken by the local public health authority or the local school governing body. For child care facilities, this action may be taken by the local public health authority.

(6) The infection control committee at all health care facilities shall adopt policies to restrict the work of employees with restrictable diseases in accordance with recognized principles of infection control. Nothing in these rules prohibits health care facilities or the local public health authority from adopting additional or more stringent rules for exclusion from these facilities.

Stat. Auth.: ORS 413.042, 431.110, 433.004, 433.329, 433.332, 616.750, & 624.005

Stats. Implemented: ORS 433.260, 433.407, 433.411 & 433.419

Hist.: HD 15-1981, f. 8-13-81, ef. 8-15-81; OHD 4-2002, f. & cert. ef. 3-4-02; PH 11-2005, f. 6-30-05, cert. ef. 7-5-05; PH 7-2011, f. & cert. ef. 8-19-11; PH 16-2013, f. 12-26-13, cert. ef. 1-1-14

333-019-0014

Removal of Restrictions

(1) Worksite, child care, and school restrictions can be removed by statement of the local public health administrator that the disease is no longer communicable to others or that adequate precautions have been taken to minimize the risk of transmission.

(2) School or child care restrictions for chickenpox, scabies, staphylococcal skin infections, streptococcal infections, diarrhea, or vomiting may also be removed by a school nurse or health care provider.

(3) Restrictions at health care facilities for chickenpox, scabies, staphylococcal skin infections, streptococcal infections, diarrhea, or vomiting may also be removed by the facility’s infection control committee when sufficient measures have been taken to prevent or minimize the transmission of disease, in accordance with written procedures approved by the committee.

(4) In general, restrictions on persons diagnosed with shigellosis or Shiga-toxigenic Escherichia coli (STEC) infection, including E. coli O157 infection shall not be lifted until no pathogens are identified by a licensed laboratory in two consecutive approved fecal specimens collected not less than 24 hours apart. Such restrictions may be waived or modified at the discretion of the local public health administrator.

(5) Individuals infected with Salmonella enterica serotype Typhi (with or without symptoms), hereinafter referred to as “typhoid cases,” must, before having a restriction removed, submit fecal specimens and one urine specimen to a licensed laboratory for testing on a schedule specified by the local public health administrator.

(6) A restriction on a typhoid case who is not a chronic carrier must be lifted by the local public health administrator when Salmonella enterica serotype Typhi is not identified by a licensed laboratory in any of four successive approved fecal specimens, collected at least 24 hours apart and not earlier than one month after illness onset, and one urine specimen.

(7) A “chronic carrier” is an individual who has fecal specimens test positive for Salmonella enterica serotype Typhi more than one year after onset or first diagnosis or on two occasions at least one year apart. A restriction on a chronic carrier may only be removed when Salmonella enterica serotype Typhi is not identified by a licensed laboratory in any of six successive approved fecal specimens, collected at least 72 hours apart, and one urine specimen.

Stat. Auth.: ORS 413.042, 431.110, 433.004, 616.010 & 624.005

Stats. Implemented: ORS 433.004, 433.260 & 433.273

Hist.: OHD 4-2002, f. & cert. ef. 3-4-02; PH 7-2011, f. & cert. ef. 8-19-11; PH 16-2013, f. 12-26-13, cert. ef. 1-1-14

333-019-0031

Acquired Immunodeficiency Syndrome/Human Immunodeficiency Virus

Investigation of cases of HIV infection or AIDS. Investigations of HIV infection or AIDS shall be conducted to the extent that resources permit. The Authority, or the local public health administrator, will ensure that each identified case is offered prevention, care, and partner counseling and referral services.

NOTE: Specific rules regarding reporting requirements for HIV and AIDS may be found in OAR 333-018-0015. Rules regarding informed consent for HIV testing and confidentiality of HIV test results may be found in OAR 333-022-0200 through 333-022-0315.

Stat. Auth.: ORS 431.110, 433.004

Stats. Implemented: ORS 431.110, 433.004

Hist.: HD 4-1987, f. 6-12-87, ef. 6-19-87; HD 15-1988, f. 7-11-88, cert. ef. 9-1-88; HD 29-1994, f. & cert. ef. 12-2-94; OHD 13-2001, f. & cert. ef. 7-12-01, Renumbered from 333-019-0223; OHD 22-2001, f. & cert. ef. 10-19-01; OHD 4-2002, f. & cert. ef. 3-4-02; PH 7-2006, f. & cert. ef. 4-17-06; PH 7-2011, f. & cert. ef. 8-19-11; PH 16-2013, f. 12-26-13, cert. ef. 1-1-14

333-019-0052

Communication during Patient Transfer of Multidrug-Resistant Organisms

(1) As used in this rule:

(a) “Facility” means:

(A) A healthcare facility as that term is defined in ORS 442.015;

(B) An infirmary (for example, in a jail or prison);

(C) A residential facility or assisted living facility as those terms are defined in ORS 443.400;

(D) An adult foster home as that term is defined in ORS 443.705;

(E) A hospice program as that term is defined in ORS 443.850; and

(F) Any other facility that provides 24-hour patient care.

(b) “Multidrug-resistant organism” (MDRO) means an organism causing human disease which has acquired antibiotic resistance, as listed and defined in the Centers for Disease Control and Prevention’s Antibiotic Resistance Threats in the United States, 2013 (Atlanta, GA; 2013). MDROs include but are not limited to:

(A) Methicillin-resistant Staphylococcus aureus (MRSA);

(B) Vancomycin-resistant Enterococcus (VRE);

(C) Carbapenem-resistant Enterobacteriaceae (CRE), as that term is defined in OAR 333-017-0000 sections (10) and (24);

(D) Multidrug-resistant Acinetobacter baumannii;

(E) Multidrug-resistant Pseudomonas aeruginosa;

(F) Drug-resistant Streptococcus pneumoniae;

(G) Other Gram-negative bacteria producing extended-spectrum beta-lactamases (ESBL); and

(H) Toxin-producing Clostridium difficile.

(c) “Receiving facility” means the facility receiving or admitting the case patient into their care from another facility’s care.

(d) “Referring facility” means the facility transferring or discharging the case patient out of its care and into another facility’s care.

(e) “Standard Precautions” means the minimum infection prevention measures that apply to all patient care, regardless of suspected or confirmed infection status of the patient, in any setting where healthcare is delivered. Standard Precautions include:

(A) Hand hygiene;

(B) Use of personal protective equipment (for example, gloves, gowns, facemasks), depending on the anticipated exposure;

(C) Respiratory hygiene and cough etiquette;

(D) Safe injection practices; and

(E) Safe handling of potentially contaminated equipment or surfaces in the patient environment.

(f) “Transmission Based Precautions” means infection control practices that are implemented in addition to Standard Precautions in patients with known or suspected colonization or infection of highly transmissible or epidemiologically important infectious pathogens (for example, CRE, norovirus, Neisseria meningitidis) or syndromes (for example, diarrhea) when there is strong evidence that the pathogen or syndrome may be transmitted from person to person via droplet, contact, or airborne routes in healthcare or non-healthcare settings (Siegel JD, Rhinehart E, Jackson M, Chiarello L, and the Healthcare Infection Control Practices Advisory Committee. Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings, 2007).

(2) When a referring facility transfers or discharges a patient who is infected or colonized with a multidrug-resistant organism (MDRO) or pathogen which warrants Transmission Based Precautions, it must include written notification of the infection or colonization to the receiving facility in transfer documents. The referring facility must ensure that the documentation is readily accessible to all parties involved in patient transfer (for example, referring facility, medical transport, emergency department, receiving facility).

(3) When a facility becomes aware that it received in transfer one or more patients with an MDRO or pathogen that warrants Transmission Based Precautions, and that was isolated from a patient specimen collected within 48 hours after transfer, it must notify the referring facility.

(4) When a facility becomes aware that it transferred or discharged one or more patients who have an MDRO or pathogen that warrants Transmission Based Precautions, the referring facility must notify the receiving facility.

(5) If a facility transfers or discharges a patient with laboratory-confirmed, carbapenemase-producing Enterobacteriaceae, the facility must notify the local health department communicable disease staff within one working day of the date and destination of the transfer or discharge.

Stat. Auth.: ORS 413.042, 431.110, 433.004, 433.010

Stats. Implemented: ORS 433.004, 433.006, 433.010, 433.110, 442.015, 443.400, 443.705, 443.850

Hist.: PH 16-2013, f. 12-26-13, cert. ef. 1-1-14

333-056-0020

Definitions Relating to Infectious Waste

As used in OAR 333-056-0010 through 333-056-0050, unless the context requires otherwise, the following definitions apply:

(1) “Act” means chapter 763, Oregon Laws, 1989, codified as ORS 459.386 to 459.405.

(2) “Disposal” means the final placement of treated infectious waste in a disposal site operating under a permit issued by a state or federal agency.

(3) “Disposal site” means land and facilities used for the disposal, handling or transfer of, or resource recovery from solid wastes, including but not limited to dumps, landfills, sludge lagoons, sludge treatment facilities, disposal sites for septic tank pumping or cesspool cleaning service, transfer stations, resource recovery facilities, incinerators for solid waste delivered by the public or by a solid waste collection service, composting plants and land and facilities previously used for solid waste disposal at a land disposal site. “Disposal site” does not include:

(a) A facility subject to the permit requirements of ORS 468.740 [468B.050];

(b) A landfill site which is used by the owner or person in control of the premises to dispose of soil, rock, concrete or other similar non-decomposable materials, unless the site is used by the public either directly or through a solid waste collection service; or

(c) A site operated by a wrecker issued a certificate under ORS 822.110.

(4) “Division” means the Oregon Health Authority, Public Health Division.

(5) “Incineration” means the reduction in volume and weight of waste by combustion.

(6) “Infectious waste” means:

(a) “Biological waste”, which includes blood and blood products, excretions, exudates, secretions, suctionings and other body fluids that cannot be directly discarded into the municipal sewer system, and waste materials saturated with blood or body fluids, but does not include diapers soiled with urine or feces. In addition, biological waste does not include articles contaminated with fully absorbed or dried blood, such as gauze, paper towels, and sanitary napkins;

(b) “Cultures and stocks”, which includes etiologic agents and associated biologicals, including specimen cultures and dishes and devices used to transfer, inoculate and mix cultures, wastes from production of biologicals, and serums and discarded live and attenuated vaccines. “Cultures” does not include throat and urine cultures;

(c) “Pathological waste”, which includes biopsy materials and all human tissues, anatomical parts that emanate from surgery, obstetrical procedures, autopsy and laboratory procedures and animal carcasses exposed to pathogens in research and the bedding and other waste from such animals. “Pathological waste” does not include teeth or formaldehyde or other preservative agents;

(d) “Sharps”, which includes needles, IV tubing with needles attached, scalpel blades, lancets, glass tubes that could be broken during handling and syringes that have been removed from their original sterile containers.

(7) “Landfill” means a facility for the disposal of solid waste involving the placement of solid waste on or beneath the land surface.

(8) “Noninfectious” means a state in which a disease causing agent is not capable of causing an infection to occur.

(9) “Saturated Waste” means waste that contains enough body fluid that it would cause dripping of the body fluid from the waste container, with or without compaction.

(10) “Sterilization” means, for purposes of these rules, any process which changes infectious waste so that disease causing agents contained within it are rendered non-infectious at the time the process is completed.

(11) “Storage” means the temporary containment of infectious waste in a manner that does not constitute treatment or disposal of such waste.

(12) “Transportation” means the movement of infectious waste from the point of generation over a public highway to any intermediate point, to the point of final treatment, and to the point of final disposal.

(13) “Treatment” means incineration, sterilization or other method, technique or process approved by the Oregon Health Authority, Public Health Division that changes the character or composition of any infectious waste so as to render the waste noninfectious. Treatment also includes methods of rendering waste noninfectious, which are approved by the Environmental Quality Commission.

Stat. Auth.: ORS 431.110, 433.004 & 459.395

Stats. Implemented: ORS 431.110, 433.004 & 459.395

Hist.: HD 15-1990, f. 6-5-90, cert. ef. 7-1-90; OHD 15-2001, f. & cert. ef. 7-12-01, Renumbered from 333-018-0050; PH 16-2013, f. 12-26-13, cert. ef. 1-1-14

333-056-0030

Infectious Waste Treatment

(1) Pathological wastes shall be treated by incineration in an incinerator that provides complete combustion of waste to carbonized or mineralized ash. However, if the Department of Environmental Quality determines that incineration is not reasonably available within a wasteshed, pathological wastes may be disposed of in the same manner provided for cultures and stocks.

(2) Cultures, stocks, sharps and biological wastes must be treated using one of the following methods, as delineated in subsections (2)(a), (b) and (c) of this rule:

(a) Treated via incineration. If incineration is utilized, it shall be done in compliance with all applicable rules established by the Environmental Quality Commission;

(b) Sterilization with saturated steam in a pressurized vessel. If this method is employed, a vessel dedicated to infectious waste treatment must be utilized. Operating procedures which must be developed and implemented shall include at least the following:

(A) Adoption of standard written operating procedures for each steam sterilizer including time, temperature, pressure, type of waste, type of container(s), type of closure on container(s), pattern of loading, and maximum load quantity. The manufacturer’s recommendations shall be taken into account;

(B) Methods for monitoring recording or temperature measuring devices during each complete cycle to ensure that the manufacturer’s recommended temperature is attained for the recommended amount of time in order to achieve sterilization of the entire load. Temperature measuring devices shall be checked for calibration at least annually;

(C) Methods for using heat sensitive tape or other device designed to indicate attainment of adequate sterilization conditions, for each container;

(D) Methods for at least monthly use of the biological indicator Bacillus stearothermophilus, or equivalent, placed at the center of a load processed under standard operating conditions, to confirm the attainment of adequate sterilization conditions;

(E) Methods for maintenance of records pertaining to paragraphs (2)(a)(A), (B) and (D) of this rule. These records shall be maintained and available for Division review for a period of not less than one year.

(c) Treated by other methods that meet the following criteria:

(A) The specific processes of the method have been tested under the conditions in which the method would be used in Oregon for the treatment of infectious waste. Such testing has demonstrated that the method is effective in rendering infectious agents non-infectious by showing bactericidal efficacy against at least spore-forming bacteria and a Mycobacterium. The testing methodology, test results, and documentation thereof must be considered scientifically valid by the Division. The determination of validity requires, but is not limited to:

(i) The testing methodology follows basic scientific principles or objectivity and is fully documented;

(ii) The results of the testing are fully documented. Raw data are made available to the Division if they are requested by the Division;

(iii) The testing has been done by a scientist(s) with an advanced degree in microbiology and with a record of having published scientific research results in a peer reviewed journal;

(iv) The report of the testing methodology and results, together with the statement “This report is an accurate and complete account of the test methods I performed and the test results I obtained” have been signed by the scientist(s) who performed the testing; and

(B) Any discharges into air or water and any solid waste resulting from the method meet the requirements of the laws and administrative rules of the Oregon Department of Environmental Quality; or

(C) The Environmental Quality Commission has approved the method and has accepted that method by administrative rule.

(3) Liquid or soluble semi-solid biological wastes may be discharged into a sewage treatment system that provides secondary treatment of waste.

(4) After treatment approved by the Division or the Environmental Quality Commission, sharps may be disposed of directly into a permitted land disposal site only if the sharps are in a red, leak-proof, rigid, puncture-resistant container which is taped closed or tightly lidded to prevent loss of the contents. The containers may not be compacted or otherwise broken before placement in the landfill. They must be placed in a segregated area of the landfill.

(5) Methods of treatment which have not been delineated in this rule or approved by the Division or the Environmental Quality Commission, as applicable, are not permitted.

Stat. Auth.: ORS 431.110, 433.004 & 459.395

Stats. Implemented: ORS 431.110, 433.004 & 459.395

Hist.: HD 15-1990, f. 6-5-90, cert. ef. 7-1-90; HD 20-1991(Temp), f. & cert. ef. 11-8-91; HD 13-1992(Temp), f. & cert. ef. 12-23-92 (and corrected 12-30-92); HD 29-1994, f. & cert. ef. 12-2-94; OHD 15-2001, f. & cert. ef. 7-12-01, Renumbered from 333-018-0060; PH 16-2013, f. 12-26-13, cert. ef. 1-1-14

333-056-0040

Infectious Waste Storage Times and Temperature

(1) Infectious waste shall be segregated from other wastes by separate containment at the point of generation.

(2) Enclosures used for storage of infectious waste shall be secured to prevent access by unauthorized persons and marked with prominent warning signs.

(3) Pathological waste, biological waste and cultures/stocks shall be treated or disposed of pursuant to OAR 333-056-0010 through 333-056-0030 within seven days of generation, unless it is refrigerated (between 33 and 48 degrees Fahrenheit) or frozen (less than 32 degrees Fahrenheit). Refrigerated or frozen infectious waste may be stored 30 days prior to treatment or disposal.

(4) Prior to being treated pursuant to OAR 333-056-0010 through 333-056-0030, sharps contained in a leak proof, rigid, puncture resistant container which is taped closed or tightly lidded to prevent loss of the contents may be stored indefinitely.

(5) Generators that produce 50 pounds or less of infectious waste in any calendar month shall be exempt from the requirements pertaining to storage times and temperatures.

Stat. Auth.: ORS 431.110, 433.004 & 459.395

Stats. Implemented: ORS 431.110, 433.004 & 459.395

Hist.: HD 15-1990, f. 6-5-90, cert. ef. 7-1-90; OHD 15-2001, f. & cert. ef. 7-12-01, Renumbered from 333-018-0070; PH 16-2013, f. 12-26-13, cert. ef. 1-1-14

333-056-0045

Exemption for Placenta Removal from a Health Care Facility

(1) Notwithstanding any other provision in these rules, a health care facility or freestanding birthing center, as those terms are defined in ORS 442.015, may release a placenta to the woman from whom the placenta originated, or to her designee, if:

(a) The facility or birthing center has a written policy and procedure to ensure the safe management and transport of placentas;

(b) The woman tested negative for infection by hepatitis B and human immunodeficiency viruses by testing obtained since the beginning of the pregnancy; and

(c) The woman, or her designee, and the woman’s health care provider sign a form that contains at least the following:

(A) The woman’s name, date of birth, address and the name of the health care provider;

(B) An attestation by the woman or her designee that the placenta will not be used for commercial purposes; and

(C) An attestation by the health care provider that:

(i) Since the beginning of the pregnancy the woman tested negative for infection by hepatitis B and human immunodeficiency viruses;

(ii) The woman either tested negative for hepatitis C virus since the beginning of the pregnancy or is not at risk for hepatitis C; and

(iii) To the health care provider’s knowledge, the woman has no infection that poses a threat to persons who handle the placenta.

(2) The health care facility or freestanding birthing center must keep a copy of the signed release form described in subsection (1)(c) of this rule in the mother’s medical record.

(3) Health care facilities and freestanding birthing centers shall make policies and procedures developed in accordance with subsection (1)(a) of this rule available to the Division upon request.

(4) Nothing in this rule prohibits a health care facility or freestanding birthing center from having additional requirements for the removal of a placenta from the facility or center.

Stat. Auth.: ORS 431.110, 433.004, 459.400

Stats. Implemented: ORS 431.110, 433.004, 459.400

Hist.: PH 16-2013, f. 12-26-13, cert. ef. 1-1-14

333-056-0050

Prevention of Disease Transmission by Blood-Contaminated Sharp Objects

Any person using sharp instruments (for example, needles, lancets, scalpels) for purposes of drawing blood, administering medication, or medical/surgical procedures on humans, shall dispose of such items in a manner that will protect any other handlers of this waste from injury. The disposal of such waste shall be in accordance with current recommendations of the U.S. Centers for Disease Control and Prevention, and shall include the use of impervious, rigid, puncture-proof containers. This rule applies to but is not limited to blood banks, plasmapherisis centers, medical clinics, dental offices, outpatient care centers, inpatient care facilities, hospitals, and home health agencies.

Stat. Auth.: ORS 431.110, 433.004 & 459.395

Stats. Implemented: ORS 431.110, 433.004 & 459.395

Hist.: HD 4-1987, f. 6-12-87, ef. 6-19-87; OHD 15-2001, f. & cert. ef. 7-12-01, Renumbered from 333-019-0212; PH 16-2013, f. 12-26-13, cert. ef. 1-1-14


Rule Caption: Vital records modernization

Adm. Order No.: PH 17-2013

Filed with Sec. of State: 12-26-2013

Certified to be Effective: 1-1-14

Notice Publication Date: 11-1-2013

Rules Adopted: 333-011-0205, 333-011-0210, 333-011-0215, 333-011-0220, 333-011-0225, 333-011-0230, 333-011-0235, 333-011-0240, 333-011-0245, 333-011-0250, 333-011-0255, 333-011-0260, 333-011-0265, 333-011-0270, 333-011-0280, 333-011-0285, 333-011-0300, 333-011-0305, 333-011-0310, 333-011-0320, 333-011-0325, 333-011-0330

Rules Repealed: 333-011-0006, 333-011-0011, 333-011-0016, 333-011-0021, 333-011-0043, 333-011-0048, 333-011-0061, 333-011-0067, 333-011-0072, 333-011-0073, 333-011-0096, 333-011-0116, 333-011-0155

Rules Ren. & Amend: 333-011-0047 to 333-011-0275, 333-011-0200 to 333-011-0290, 333-011-0076 to 333-011-0295, 333-011-0110 to 333-011-0315, 333-011-0101 to 333-011-0335, 333-011-0106 to 333-011-0340

Subject: The Oregon Health Authority, Public Health Division is permanently amending rules in chapter 333, division 11 pertaining to vital records. The rules are being revised to align with House Bill 2093 (Oregon Laws 2013, chapter 366), the vital records modernization bill, passed by the Oregon legislature in June 2013. House Bill 2093 reorganized and updated Oregon vital records and vital statistics law. The reorganization and modernization of the law was based on a model law that was written between 2009 and 2011 by the National Center for Health Statistics in collaboration with the National Association for Public Health Statistics and Information Systems. The last model law was in 1992, and Oregon implemented that model in 1997. House Bill 2093 updated laws to account for changes in technology, security and parentage.

   The new law takes effect January 1, 2014 and requires additional rules as well as updates to current rules. The subjects of the rules includes reports of live birth, reports of death, reports of fetal death, marriages, Oregon registered domestic partnerships, dissolutions of marriage or domestic partnerships, amendments of records, and county vital records offices. The goal of these rules is to implement the new laws.

Rules Coordinator: Brittany Sande—(971) 673-1291

333-011-0205

County Vital Records Services

A county registrar may only sell certified copies of records with authorization by the state registrar. A county registrar may apply to the state registrar for authorization to sell certified copies of death records or certified copies of birth records and death records. The application shall specify the county need and interests that the sale of certified copies would serve, types of records to be issued, and hours of service available. The state registrar shall review the application and authorize the county registrar to sell certified copies if such action is supported by local needs and resources.

(1) If approved for birth records, the county registrar may issue certified copies of registered birth records from the state vital records system for a period not to exceed six months from the date of birth.

(2) If approved for death records, the county registrar may accept after review paper death records for deaths occurring in the county prior to registration at the state office. The county registrar shall forward death records that have been filed at the county to the state registrar within three business days of the date filed by the county registrar.

(a) County registrars may issue certified copies from the original record while the original record is in the possession of the county. County registrars may maintain a copy of the completed death record for a period up to 14 calendar days from the date the record is forwarded to the state and within that time period may issue from that copy until the record is registered in the state vital records system.

(b) After the death record is registered in the state vital records system, whether originally a paper record or an electronic record, the county registrar may issue only from the state vital records system for a period not to exceed six months from the date of death.

Stat Auth: 2013 OL Ch. 366, Sec. 7

Stats. Implemented: 2013 OL Ch. 366, Sec. 7

Hist.: PH 17-2013, f. 12-26-13, cert. ef. 1-1-14

333-011-0210

Prenatal Care Information

(1) The physician, institution or other person providing prenatal care shall transfer the prenatal care information including but not limited to pregnancy history, date of first visit, number of visits, pregnancy risk factors, and cigarette use as required in Oregon Laws 2013, chapter 366, section 10 to the institution where the delivery is expected to occur not less than 30 calendar days and not more than 45 calendar days prior to the expected delivery date.

(2) If the institution where the delivery is expected to occur has direct access to the prenatal care information, the physician, institution or other person providing prenatal care may authorize direct access to the information.

(3) If the institution where the delivery is expected to occur does not have direct access to the prenatal care information or direct access is not authorized by the physician, institution or other person providing prenatal care, the prenatal care provider shall send by facsimile or otherwise electronically transmit in a secure manner the prenatal care information on a form prescribed by the State Registrar of the Center for Health Statistics.

Stat Auth: 2013 OL Ch. 366, Sec. 10

Stats. Implemented: 2013 OL Ch. 366, Sec. 10

Hist.: PH 17-2013, f. 12-26-13, cert. ef. 1-1-14

333-011-0215

Registering Live Births that Occur Outside of a Facility with a Licensed Birth Attendant or Non-licensed Midwife within One Year of the Date of Birth

(1) For purposes of this rule, attendant means:

(a) A physician;

(b) A nurse practitioner as defined in ORS 678.010;

(c) A direct entry midwife licensed under ORS 687.405 to 687.495; or

(d) A person not required by law to be licensed to practice midwifery who is registered with the Center for Health Statistics to submit reports of live birth.

(2) Any individual listed in subsections (1)(a) through (d) of this rule who attends a birth that occurred outside a health care facility must register the birth with the Center for Health Statistics.

(a) Information regarding the birth may be submitted through the state electronic vital records system or through a paper report of live birth. All information required in the report of live birth must be received by the Center for Health Statistics prior to registration.

(b) Reports of live birth submitted within one year from the date of birth shall not be marked “Delayed.”

(c) The attendant may submit the report of live birth based on existing medical records.

(A) Personal information, such as the name of the child, can be completed from information provided by the parent at the time of birth.

(B) If the birth cannot be confirmed through other public health sources including but not limited to newborn metabolic screening, first dose immunization records, or early hearing test, the state registrar may require the parents to submit additional documents that support the birth of the child in Oregon or present the child at the county vital records office.

(d) The state registrar may request additional documentation from the attendant or explanation of the delay in submitting the report of live birth for reports submitted more than 10 days after the date of birth.

(e) The state registrar shall review and register reports of live birth submitted within one year from the date of birth using the same process for reviewing and registering reports of births submitted within five days from the date of birth.

(3) An attendant who attends the birth of their own child, grandchild, niece or nephew must submit the application and documentation required under OAR 333-011-0220 if the birth does not occur in a licensed medical facility.

Stat Auth: 2013 OL Ch. 366, Sec. 10

Stats. Implemented: 2013 OL Ch. 366, Sec. 10

Hist.: PH 17-2013, f. 12-26-13, cert. ef. 1-1-14

333-011-0220

Registering Live Births that Occur Outside of a Facility and Without a Licensed Attendant within One Year of the Date of Birth

When a birth occurs outside a licensed health care facility, the birth attendant is not an attendant described in OAR 333-011-0215 and a report of live birth has not been submitted to the state registrar, the mother, the father if the father’s relationship to the child is legally established, the legal guardian, or a state agency with physical custody shall fill out a form prescribed by the state registrar to report the live birth and provide additional evidence to the state register if the birth occurred within one year of the report being submitted to the Center for Health Statistics.

(1) The individual submitting the report of live birth must also submit evidence to establish the following facts:

(a) The mother was pregnant at the time relevant to the birth. If the birth cannot be confirmed through other public health sources, the parents must submit additional documents that support the birth of the child in Oregon. Evidence of the pregnancy can include but is not limited to:

(A) Prenatal record or a statement from a physician or other health care provider qualified to determine pregnancy who examined the mother during the pregnancy; or

(B) Chart notes from a home visit by a public health nurse or other health care provider that include observation of the pregnancy.

(b) A live birth resulted from the pregnancy. Evidence that the infant was born alive can include but is not limited to:

(A) A statement from a physician, naturopathic doctor, nurse practitioner, or registered nurse who saw or examined the infant within three months of the birth; or

(B) Chart notes of an observation of the infant during a home visit by a public health nurse within three months of the birth; or

(C) Presentation of the child at the state or county vital records office.

(c) The mother was present in Oregon at the time of birth. Evidence of the mother’s presence in this state within 30 days of the date of the live birth and inclusive of the date of birth can include but is not limited to:

(A) A rent receipt that includes the mother’s name and address; or

(B) A utility, telephone, or other bill that includes the mother’s name and address.

(d) Information on the identity of the mother and information on the identity of the father if the father is to be listed on the record of live birth. Evidence of the identity of the mother or the father shall include:

(A) An official identification document from a government agency that includes a photograph of the mother or of the father; and

(B) A certified copy of the mother’s or father’s birth record; or

(C) Other official documents acceptable to the state registrar.

(2) If a parent’s current legal name does not match the name on his or her birth record, evidence of the legal name change through court order, marriage or other legal process must be provided.

(3) If the father is listed on the record of live birth because the mother and father are married, a certified copy of a marriage record for the mother and the father must be submitted.

(4) After the application is received and evidence has been submitted, the state registrar shall review the documents and application, and verify any documentation at the state registrar’s discretion.

(5) The state registrar shall determine if a previously registered record of live birth exists for the registrant. If no previously registered record is identified and the submitted application and evidence appear valid, the record may be registered.

(6) Reports of live birth filed within one year from the date of birth shall not be marked “Delayed.”

Stat Auth: 2013 OL Ch. 366, Sec. 10

Stats. Implemented: 2013 OL Ch. 366, Sec. 10

Hist.: PH 17-2013, f. 12-26-13, cert. ef. 1-1-14

333-011-0225

Registering Live Births that Occur in a Licensed Medical Facility More Than One Year after the Date of Birth

All reports of live birth for births occurring in licensed medical facilities certified more than one year from the date of live birth are to be submitted by hospital staff through the electronic system and registered on the current form in use.

(1) Births may be matched to newborn screening records for the purpose of confirming the birth occurred.

(2) Reports of live birth submitted more than one year from the date of birth shall be marked “Hospital Delayed” and include a footnote that the record was filed based on the medical facility’s record of the live birth.

(3) The facility administrator or designee shall submit the report of live birth based on existing medical or business records related to the birth if all facts of birth appear in the medical or business records. Personal information, such as the name of the child, can be completed from information provided by the parent at the time of birth.

(4) The facility administrator or designee shall include an explanation of the delay in submitting the report of live birth and the facility records on which the report of live birth is based.

(5) The state registrar shall determine if a previously registered record of live birth exists for the registrant and may inspect the medical facility’s medical and business records prior to registration. If no previously registered record is identified and the submitted record appears valid, the record may be registered.

Stat Auth: 2013 OL Ch. 366, Sec. 14

Stats. Implemented: 2013 OL Ch. 366, Sec. 14

Hist.: PH 17-2013, f. 12-26-13, cert. ef. 1-1-14

333-011-0230

Registering Live Births that Occur Outside a Facility More Than One Year after the Date of Birth

(1) When a live birth that occurred outside a licensed medical facility has not been registered within one year from the date of birth, an application for a delayed registration of live birth may be submitted. The applicant shall complete a delayed report of live birth application form prescribed by the state registrar, pay the delayed filing fee, and shall provide additional documentation described in this rule.

(a) If the proposed registrant is age 18 or older, the proposed registrant must file the application unless the proposed registrant has a legal guardian due to incapacity. If the proposed registrant is age 18 or older and has a legal guardian due to incapacity, the legal guardian may file the application on behalf of the proposed registrant.

(b) If the proposed registrant is less than age 18, the mother, the father if legal relationship is established, the legal guardian, or a state agency with physical custody may file the application.

(c) No delayed report of live birth shall be registered for a deceased person.

(2) A delayed registration of birth application form shall be signed by the person authorized to request a delayed registration of birth as described in subsections (1)(a) and (b) of this rule and sworn to before an official authorized to administer oaths, swearing to the accuracy of the facts stated therein.

(3) In addition to completing the delayed registration of live birth application, the applicant must submit documents to establish the facts of birth including:

(a) The full name of the proposed registrant at the time of birth;

(b) The date of birth;

(c) The place of birth within Oregon;

(d) The mother’s full name at birth and current full legal name; and

(e) Proof that a record does not currently exist in Oregon.

(4) If the mother was not married either at the time of conception or birth or within 300 days prior to the birth, the state registrar shall not enter the name of the father on the delayed record of live birth for a minor child except upon receipt of a voluntary acknowledgment of paternity as provided in OAR 333-011-0270 or upon receipt of a court order establishing paternity.

(5) A delayed registration of birth application completed and submitted to the state registrar within 10 years of the birth of the proposed registrant must include three pieces of documentary evidence that support the facts of birth.

(a) One of the three documents must establish the mother’s residence address in Oregon within 30 days of the date of the live birth and inclusive of the date of birth. A personal affidavit cannot be used to establish residence.

(b) One document other than a personal affidavit must have the full name at birth of the proposed registrant, the date of birth, and the full legal name or the full name at birth of the mother. This document must be dated either:

(A) Before the first birthday of the proposed registrant; or

(B) At least one year prior to the date of the application.

(c) One of the documents may be a personal affidavit. To be accepted, a personal affidavit must be signed by a person who is at least 18 years of age and is at least 10 years older than the proposed registrant. That person must have personal knowledge of the facts of birth and not be a family member of either parent.

(d) In addition to the facts of birth, information on the identity of the mother and father is required.

(A) Evidence of the identity of the mother shall include:

(i) An official identification document from a government agency that includes a photograph of the mother; and

(ii) A certified copy of the mother’s record of birth; or

(iii) Other official documents acceptable to the state registrar.

(B) Evidence of the identity of the father if the father is to be listed on the record of live birth shall include:

(i) An official identification document from a government agency that includes a photograph of the father; and

(ii) A certified copy of the father’s record of birth; or

(iii) Other official documents acceptable to the state registrar.

(C) If a parent’s current legal name does not match the name on his or her record of birth, evidence of the legal name change through court order, marriage or other legal process must be provided.

(e) If the father is listed on the birth report because the mother and father are married, a certified copy of a marriage record for the mother and the father must be submitted.

(6) If a delayed registration of live birth application is completed and submitted to the state registrar 10 years or later after the date of birth of the proposed registrant, at least three pieces of documentary evidence shall be submitted with the application for delayed record of live birth.

(a) All documents must have been established:

(A) Prior to the proposed registrant’s 10th birthday and at least one year prior to the date of application; or

(B) At least 10 years prior to the date of application.

(b) One document must have the full name at birth of the proposed registrant, the date of birth or age, the place of birth within Oregon, and the mother’s first and last name prior to marriage.

(c) The remaining two documents must have the name of the proposed registrant, the date of birth or age, and place of birth. One document of the three must include the registrant’s first and last name, date of birth and place of birth within Oregon.

(d) The father will be included on the record of live birth if the proposed registrant is age 18 or older and the evidence submitted documents the identity and relationship.

(e) Documents in addition to the three required may include first and last names only and do not need to include the date of birth and place of birth if sufficient information appears in the document to clearly identify the proposed registrant as the subject of the document. These documents may be used to correct the spelling of a name or to add information missing from the three documents required, such as a parent’s place of birth.

Stat Auth: 2013 OL Ch. 366, Sec. 14

Stats. Implemented: 2013 OL Ch. 366, Sec. 14

Hist.: PH 17-2013, f. 12-26-13, cert. ef. 1-1-14

333-011-0235

Documentation in Support of an Application to Register a Delayed Report of Live Birth

(1) The following documents shall be considered by the state registrar to meet the documentation requirements for delayed registration of live birth described in OAR 333-011-0230 if the documents contain sufficient information to identify the proposed registrant as the subject of the document and support the facts of birth as reported by the applicant. Documents may include:

(a) Licensed medical facility records of the proposed registrant;

(b) A certified copy of an accepted application for a Social Security card for the proposed registrant;

(c) The proposed registrant’s mother’s medical record if the proposed registrant’s name, date of birth and place of birth are included in the record;

(d) A certified copy of school records of the proposed registrant;

(e) A certified copy of census records;

(f) Military records of the proposed registrant;

(g) A certified copy of marriage record;

(h) A certified copy of birth record of the proposed registrant’s child;

(i) Voter registration records for the proposed registrant; or

(j) Other official documents acceptable to the state registrar.

(2) All documents submitted in support of an application for delayed registration of live birth must be original documents or certified copies of original documents. Certified copies must be authenticated by the official custodian of the record.

Stat Auth: 2013 OL Ch. 366, Sec. 14

Stats. Implemented: 2013 OL Ch. 366, Sec. 14

Hist.: PH 17-2013, f. 12-26-13, cert. ef. 1-1-14

333-011-0240

Review and Filing of Delayed Registration of Live Birth

(1) The state registrar shall review the application for delayed registration of birth and documents in support of the application for authenticity, relevance and content required by OAR 333-011-0230. If the application cannot be approved as submitted, the applicant will be notified by correspondence or electronic mail of the deficiencies and provided an opportunity to submit additional documentation.

(2) The state registrar shall review the delayed registration of live birth application and the documents submitted, and shall search to confirm there is no existing birth record for the proposed registrant in Oregon. If the state registrar finds no such records and finds that the documents submitted are adequate to establish that the proposed registrant was born in Oregon on the date specified, the state registrar or the state registrar’s designated representative shall register the record and include on the record of delayed registration of live birth an abstract of the evidence supporting the delayed report of live birth.

(3) If the application and evidence is accepted, the state registrar shall send the delayed report of live birth, including the abstract of evidence, to the applicant for notarized signature.

(4) When the notarized delayed report of live birth with the applicant’s notarized signature is received, the state registrar shall create the delayed record of live birth. The record of live birth shall be marked ‘Delayed’ and shall include a description of each document submitted to support the facts shown on the delayed birth record. This description shall include:

(a) The title or description of the document;

(b) The name of the affiant, if the document is an affidavit of personal knowledge, or of the custodian, if the document is an original or certified copy of a record or a signed statement from the custodian;

(c) The date of the original filing of the document being abstracted; and

(d) The information regarding the birth facts contained in the document.

(5) The state registrar shall return all original documents other than personal affidavits submitted in support of the application for delayed registration of live birth and received directly from the applicant to the applicant after review. A copy of the personal affidavit shall be provided to the applicant. Copies of documents and application will be maintained for delayed registrations of live birth that are accepted for registration.

Stat Auth: 2013 OL Ch. 366, Sec. 14

Stats. Implemented: 2013 OL Ch. 366, Sec. 14

Hist.: PH 17-2013, f. 12-26-13, cert. ef. 1-1-14

333-011-0245

Denial of Application for Delayed Registration of Live Birth after Two Years

(1) An application for an out of facility record of live birth or delayed record of live birth which is not completed through the submission of required evidence of all facts to be established as identified in rule within two years of application shall be denied. The applicant shall be notified of the right to appeal the decision of the state registrar under ORS 183.484. The applicant may request denial for the purpose of seeking a court order prior to two years.

(2) Any applicant that has had a previous application denied must file a new application for the proposed registrant including the fee if choosing to submit a new application for delayed registration of birth.

(3) Copies of the application and submitted documentation will be maintained according to the agency’s retention schedule and may be used if a subsequent application indicates contradictory information.

Stat Auth: 2013 OL Ch. 366, Sec. 14

Stats. Implemented: 2013 OL Ch. 366, Sec. 14

Hist.: PH 17-2013, f. 12-26-13, cert. ef. 1-1-14

333-011-0250

Court Ordered Birth Records

A certified copy of each order to establish a record of birth shall be forwarded to the State Registrar from the court clerk by the 5th and 15th working day of each month. The order shall be in the form specified by the State Registrar and shall be suitable for issuing certified copies of the birth record on a single sheet.

Stat Auth: ORS 432.142

Stats. Implemented: ORS 432.142

Hist.: PH 17-2013, f. 12-26-13, cert. ef. 1-1-14

333-011-0255

Infants of Unknown Parentage

(1) A report for a minor child of unknown parentage found in Oregon shall be registered in the current format for births.

(2) If the minor child is less than one year of age, the hospital where the child is examined shall submit the report of live birth in the state’s electronic reporting system.

(3) If the minor child is more than one year of age, the agency who has assumed custody of the child shall submit a request to locate birth record to the state registrar. The request shall include:

(a) A statement that the child is a possible foundling;

(b) All information available on the identity of the child and parents for the purpose of identifying the birth record;

(c) Whether the agency will be able to locate evidence to support a delayed record of birth if a birth record is not identified;

(d) Whether an expedited denial is requested for the purpose of obtaining a court order to register the birth.

(4) If the agency requests expedited denial, the state registrar shall review the information available and determine whether a birth record can be identified. If no birth record can be identified based on the information provided by the agency and the agency cannot provide additional documentation to support a delayed record of birth, the state registrar shall issue a denial of the request.

(5) If the agency later identifies the child’s parents, the agency shall notify the state registrar within 10 days of the additional information. If a previously registered record is identified with the child’s information, the record registered under this rule shall be voided. If no registered record with the parent information is found, the agency shall amend the court order to register the birth to include the names, dates of birth and places of birth of the parents.

Stat Auth: 2013 OL Ch. 366, Sec. 13

Stats. Implemented: 2013 OL Ch. 366, Sec. 13

Hist.: PH 17-2013, f. 12-26-13, cert. ef. 1-1-14

333-011-0260

Amendment of the Same Item More than Once

Once an amendment of an item is made on a vital record, except for cause and manner of death to be amended by the medical certifier or Medical Examiner or clerical error on the part of the reporting source or the state registrar, that item shall not be amended again except upon receipt of an appropriate order which, depending on the nature of the order, shall be from either a court of competent jurisdiction or a court with competent jurisdiction over the state agency.

Stat Auth: 2013 OL Ch. 366, Sec. 29

Stats. Implemented: 2013 OL Ch. 366, Sec. 29

Hist.: PH 17-2013, f. 12-26-13, cert. ef. 1-1-14

333-011-0265

Amending Birth Records

(1) All amendments. Unless otherwise provided in these rules or in statute, all amendments to vital records shall be supported by:

(a) An affidavit setting forth:

(A) Information to identify the record;

(B) The incorrect data as it is listed on the record; and

(C) The correct data as it should appear.

(b) One or more original items of documentary evidence which support the alleged facts and which were established at least five years prior to the date of application for amendment or within seven years of the date of the event and one year prior to the date of the requested amendment.

(2) The state registrar shall evaluate the evidence submitted in support of any amendment, and when the state registrar finds reason to doubt its validity or adequacy the amendment may be rejected and the applicant advised of the reasons for this action.

(3) Who may apply:

(a) To change the date of birth, time of birth or sex of the registrant, only the facility where the birth occurred or the individual who submitted the report of birth may apply to amend unless the medical record is no longer available at the facility. If the medical record is no longer available, other individuals, including the parents and the registrant, shall submit an application for amendment under section (1) of this rule. If the evidence is not sufficient, the applicant must present a certified copy of a court order ordering such amendment.

(b) To amend a record of live birth for items other than date of birth, time of birth or sex, application may be made by one of the parents, the legal guardian, the registrant if 18 years of age or over, or the individual responsible for filing the report of live birth.

(c) To amend the sex of a registrant on a record of live birth following the completion of sexual reassignment, an individual must submit documentation under OAR 333-011-0275.

(4) Amendment of registrant’s first, middle or last names on records of live birth within the first year. Until the registrant reaches the age of one year, first, middle, or last names of the registrant may be amended upon written request of:

(a) Both parents; or

(b) The mother if no father or second parent appears on the record or if the father or second parent is deceased or incapacitated; or

(c) The father or second parent if the mother is deceased or incapacitated; or

(d) The legal guardian or agency having legal custody of the registrant.

(5) Amendment of registrant’s first, middle or last names on records of live birth after the first year:

(a) After one year from the date of birth the provisions of section (1) of this rule must be followed to amend a first, middle or last name if the name was misspelled on the birth record.

(b) A legal change of name order must be submitted from a court of competent jurisdiction to change a first, middle or last name that appears on the birth record after one year from date of birth.

(6) Addition of first, middle or last name of a registrant on a record of live birth:

(a) Until the registrant’s seventh birthday, first, middle and last names, for a child whose birth was registered without such names, may be added to the record of live birth upon written request of:

(A) Both parents; or

(B) The mother if no father appears on the record or if the father is deceased or incapacitated; or

(C) The father if the mother is deceased or incapacitated; or

(D) The legal guardian or agency having legal custody of the registrant.

(b) After seven years the provisions of section (1) of this rule must be followed to add a first, middle or last name.

(7) Amendment of parents’ information on birth records. When a requested amendment to an item, in combination with previous amendments or concurrent requests for amendment, would appear to change the identity of the parent through cumulative changes to name, date of birth, or place of birth, the state registrar shall only make such an amendment upon receipt of a court order from a court of competent jurisdiction.

(8) Original evidence documents submitted to correct errors in the spelling of a parent name, parent date of birth, or parent place of birth must be dated prior to the birth of the child.

(9) Birthing facilities may correct typographical errors on birth records within the first year. After one year, only errors in the child’s date of birth, time of birth or sex will be accepted directly from the birthing facility. The birthing facility must have access to the medical record when submitting the correction.

(10) For births occurring outside a birthing facility, medical certifiers may only correct typographical errors within the first year with evidence from the medical record or the birth worksheet.

(11) Amendment of minor errors on birth records. Amendment of obvious errors, transposition of letters in words of common knowledge, or omissions may be made by the state registrar either upon the state registrar’s observation or upon request of one of the parents, the legal guardian, or the birthing facility or by the individual responsible for filing the report of live birth. The record shall not be marked “Amended”. Corrections to names will not be considered minor errors.

(12) In all cases where the record is amended, there shall be inserted on the record a statement identifying the affidavit or documentary evidence used as proof of the correct facts, the date the amendment was made, and the initials of the person making the change. As required by statute or rule, the record shall be marked “Amended”.

Stat Auth: 2013 OL Ch. 366, Sec. 29

Stats. Implemented: 2013 OL Ch. 366, Sec. 29

Hist.: PH 17-2013, f. 12-26-13, cert. ef. 1-1-14

333-011-0270

Voluntary Acknowledgment of Paternity

(1) Any voluntary acknowledgment paternity form establishes paternity, and the establishment of paternity shall be a rebuttable presumption. Forms must contain all information necessary to comply with existing federal and state laws and regulations for determination and recording of paternity including but not limited to:

(a) The current full names of mother, father and child;

(b) The social security numbers of mother and father if available;

(c) The dates of birth for mother, father and child;

(d) The address(es) of the mother and of the father;

(e) The birthplace of the child;

(f) A brief explanation of the legal significance of signing a voluntary paternity affidavit and a statement that both parents have 60 days to rescind the paternity acknowledgment affidavit;

(g) A statement signed by both parents indicating they understand that signing the paternity acknowledgment is voluntary and that they understand the rights, responsibilities, alternatives to signing, and consequences of signing;

(h) Signature lines for the mother and the father; and

(i) Signature lines for witnesses or notaries.

(2) The witnessed voluntary acknowledgment of paternity form is established for completion in a health care facility where births occur. This form can be used by unwed biological parents if:

(a) The mother was not married at conception, at birth, or within 300 days prior to the birth;

(b) The form is completed:

(A) After the birth; and

(B) While the mother is admitted for this birth; and

(c) The form is witnessed by a member of the hospital staff; and

(d) The form is submitted to the Center for Health Statistics within five days after the birth.

(e) This form will not be accepted and the father’s information will not be placed on this record of live birth if any of these conditions are not met.

(3) Completion of a voluntary acknowledgment of paternity form and returning the form to the hospital staff for submission is the responsibility of the biological parents.

(4) The notarized voluntary acknowledgment of paternity form can be used by unwed biological parents if:

(a) The mother was not married at conception, at birth, or within 300 days prior to the birth;

(b) The form is completed after the birth; and

(c) Signatures of each biological parent are notarized.

(d) This form will not be accepted and the father’s information will not be placed on this record of live birth if any of these conditions are not met.

(5) The State Registrar of the Center for Health Statistics shall consult the Division of Child Support on the language in the rights and responsibility statement for voluntary acknowledgment of paternity forms to ensure compliance with state and federal law and regulations.

(6) All questions regarding acceptability of a completed form are determined by the State Registrar for the Center for Health Statistics. Appeals of decisions of determination of the state registrar will be made under ORS 183.484.

Stat Auth: 2013 OL Ch. 366, Sec. 12

Stats. Implemented: 2013 OL Ch. 366, Sec. 12

Hist.: PH 17-2013, f. 12-26-13, cert. ef. 1-1-14

333-011-0275

New Record of Birth Following Adoption, Legitimation, Paternity Determination, and Paternity Acknowledgement or Sexual Reassignment

(1) The state registrar shall amend a record of live birth and establish a replacement record of live birth for a person born in this state upon receipt of the following:

(a) Legitimation. If the mother is unmarried at the time of birth and the biological parents marry after the birth of a child, a new record of live birth shall be prepared by the state registrar for a child born in this state upon receipt of a sworn acknowledgement of paternity signed by the biological parents of said child together with a certified copy of the parents’ marriage record. The mother’s legal name can be amended to the name taken at marriage on the child’s record of live birth if requested.

(b) Determination of paternity. A new record of live birth shall be prepared by the State Registrar for a child born in this state upon receipt of a certified copy of a court determination of paternity. If the mother’s marital status was not unmarried at the time of birth or if another man is listed as the father, the court order must disestablish paternity as well as establish the new father. If the surname of the child is not decreed by the court, the request for the new record received with the certified copy of the court determination shall specify the surname requested by both parents to be placed on the record.

(c) Acknowledgement of paternity. A new record of live birth shall be prepared by the state registrar for a child born to an unmarried mother in this state upon acceptance of a notarized voluntary acknowledgement of paternity signed by both parents if no father appears on the record. The child’s surname may be changed through the voluntary acknowledgment of paternity.

(d) Adoption. A certified copy of a report of adoption as provided in ORS 432.415 or a certified copy of the decree of adoption, together with the information necessary to identify the original record of live birth and to establish a replacement record of live birth, except that a replacement record of live birth shall not be established if so requested by the court decreeing the adoption.

(e) Sexual reassignment. A certified copy of an order of a court of competent jurisdiction indicating that an individual born in this state has completed sexual reassignment and that the sex on the record of live birth shall be changed.

(2) The mother’s marital status is unmarried at the time of birth if she was not married at conception, at birth, or within 300 days prior to the birth.

(3) New record:

(a) The new record of live birth prepared after adoption, legitimation, determination of paternity, or acknowledgment of paternity, or sexual reassignment shall be on the form in use at the time of its preparation and shall include the following items and such other information necessary to complete the certification:

(A) The name of the child;

(B) The date and place of birth as transcribed from the original record;

(C) The full names, dates of birth and places of birth of the adoptive parents or the biological parents whichever is appropriate;

(D) The name of the attendant;

(E) The state file number assigned to the original birth record; and

(F) The original filing date.

(b) The information necessary to locate the existing record and to complete the new record shall be submitted to the state registrar on forms prescribed or approved by the state registrar.

(4) Existing record to be placed in a special file. After preparation of the new record, the existing record and the evidence upon which the new record was based are to be placed in a special file. Such file shall not be subject to inspection except upon order of a court of competent jurisdiction or by the state registrar for purposes of properly administering the vital statistics program. A court order is not required before the release of a Voluntary Acknowledgment of Paternity form to any government agency responsible for the administration of child support enforcement programs created under Title IV-D of the Social Security Act, to a parent who signed the form or to the registrant if age 18 or older.

Stat. Auth.: ORS 432.230, 432.287 & 432.289

Stats. Implemented: ORS 432.230, 432.287 & 432.289

Hist.: HD 24-1981, f. & ef. 11-17-81; PH 2-2003(Temp), f. & cert. ef. 2-20-03 thru 8-19-03; PH 11-2003, f. & cert. ef. 7-31-03; Renumbered from 333-011-0047 by PH 17-2013, f. 12-26-13, cert. ef. 1-1-14

333-011-0280

Extension of Time for Submission of Report of Death or Fetal Death

(1) Upon written request by the funeral service practitioner, person acting as a funeral service practitioner, or Medical Examiner, the state registrar may extend the period to file a report of death, not to exceed 60 days.

(2) Upon written request by the facility administrator or the Medical Examiner, the state registrar may extend the period to file a report of fetal death, not to exceed 60 days.

(3) The request shall include the date of event, name of the decedent if a report of death or name of the mother if a report of fetal death, and an explanation of why the extension of time is required.

(4) The state registrar shall respond to such request within two business days of receipt. The request may be faxed or otherwise transmitted electronically, but must include a signature of the person requesting the extension.

Stat Auth: 2013 OL Ch. 366, Sec. 21

Stats. Implemented: 2013 OL Ch. 366, Sec. 21

Hist.: PH 17-2013, f. 12-26-13, cert. ef. 1-1-14

333-011-0285

Report of Fetal Death Which Occurred Outside a Licensed Medical Facility

When a fetal death occurs outside a licensed medical facility, the report of fetal death must be submitted by the Medical Examiner or physician who attended at or immediately after the delivery through the electronic reporting system.

Stat Auth: 2013 OL Ch. 366, Sec. 19

Stats. Implemented: 2013 OL Ch. 366, Sec. 19

Hist.: PH 17-2013, f. 12-26-13, cert. ef. 1-1-14

333-011-0290

Commemorative Certificate of Stillbirth

(1) The Certificate of Stillbirth shall be suitable for display and shall feature an attractive design with calligraphy-like font, high quality paper, a State of Oregon seal, and signature of the state registrar.

(2) Information on the Certificate of Stillbirth shall be prepared using information from the “Report of Fetal Death” submitted to the Center for Health Statistics. The text of the certificate shall contain the name of the child, date and place of birth, names of parent(s), date of issuance, state file number from the fetal death record, and a statement that the certificate is not proof of a live birth. The word deceased would be included after the name of the child.

Stat. Auth.: ORS 432.266

Stats. Implemented: ORS 432.266

Hist.: PH 27-2006, f. 11-30-06, cert. ef. 12-1-06; Renumbered from 333-011-0200 by PH 17-2013, f. 12-26-13, cert. ef. 1-1-14

333-011-0295

Authorization for Final Disposition

(1) Removal of body. Before removing a dead body or fetus from the place of death, the funeral director or person acting as such shall:

(a) Obtain assurance from the attending physician that death is from natural causes and that the physician will assume responsibility for certifying to the cause of death or fetal death and receive permission to remove the body from the place of death; or

(b) Notify the medical examiner, if the case comes within the medical examiner’s jurisdiction and obtain authorization to remove the body.

(2) Authorization for disinterment and reinterment. An authorization for disinterment and reinterment of human remains shall be issued by the state registrar upon receipt of a written application signed by the next of kin and the person who is in charge of the disinterment or upon receipt of an order of a court of competent jurisdiction directing such disinterment:

(a) Upon receipt of such a court order or signed permission of the next of kin, the state registrar may issue one authorization to permit disinterment and reinterment of all human remains in a mass disinterment provided that, insofar as possible, the remains of each body be identified and the place of disinterment and reinterment specified. The authorization shall be permission for disinterment, transportation, and reinterment;

(b) Human remains properly prepared by an embalmer and deposited in a receiving vault shall not be considered a disinterment when removed from the vault for final reinterment within the same cemetery.

Stat. Auth.: ORS 432.317

Stats. Implemented: ORS 432.317

Hist.: HB 169, f. & ef. 10-16-63; HD 24-1981, f. & ef. 11-17-81; Renumbered from 333-011-0076 by PH 17-2013, f. 12-26-13, cert. ef. 1-1-14

333-011-0300

Amendments to Death Records

(1) To amend a death record, application may be made by the informant, the next of kin of the decedent, person acting as the funeral service practitioner who signed the report of death, or a funeral service practitioner employed by the licensed funeral establishment that submitted the report of death.

(a) Next of kin is, in order of preference:

(A) Spouse of the decedent;

(B) A son or daughter age 18 or older of the decedent;

(C) The mother or the father of the decedent;

(D) A brother or sister age 18 or older of the decedent;

(E) The guardian of the decedent at the time of death;

(F) The personal representative of the estate of the decedent; or

(G) The person nominated as the personal representative of the decedent in the decedent’s will.

(b) Applications to amend the medical certification of cause of death shall be made only by the physician who signed the medical certification or the medical examiner.

(c) A completed and signed affidavit in a format prescribed by the state registrar is required for all amendments.

(2) When the marital/partnership status is shown as married/partnered and a surviving spouse/partner is listed on the death record of the decedent then the marital/partnership status shall be changed to:

(a) Widowed and the spouse/partner removed if a certified copy of a death record for the spouse/partner documenting that the spouse/partner died prior to the death of the decedent is submitted by the informant.

(b) Divorced or never married and the spouse/partner removed if a certification of divorce/dissolution/annulment documenting that the event occurred prior to the death of the decedent is submitted by the informant.

(3) If the marital/partnership status is shown as married/partnered and surviving spouse/partner is listed as unknown or is blank on the death record, then a certified copy of the record of marriage/partnership must be provided to add the name of the surviving spouse/partner.

(4) If the marital/partnership status is shown as married/partnered and the surviving spouse/partner is listed on the death record then an order from a court of competent jurisdiction will be needed to change that spouse/partner to a different person.

(5) When the marital/partnership status is shown as divorced, widowed, or never married and no surviving spouse/partner is listed on the death record of the decedent then the marital/partnership status shall be amended to married/partnered and the surviving spouse/partner added upon receipt of notarized affidavits from both the informant and from the alleged surviving spouse/partner stating that an error was made and stating the correct information, and either:

(a) A certified copy of the marriage/partnership record showing that the person to be listed as the surviving spouse/partner was married to/partnered with the decedent prior to death is submitted by the informant; or

(b) An order from a court of competent jurisdiction issued in a legal action indicating that the person was in a common-law marriage with the decedent at the time of the decedent’s death.

(6) Other changes to marital/partnership status and surviving spouse/partner will be made only upon the finding of a court of competent jurisdiction in an order that determined the marital/partnership status of the decedent and identifies the surviving spouse/partner, if appropriate.

(7) For sections (2) through (5) of this rule, in addition to documentation required, the informant listed on the death record shall be notified of the requested change and given the opportunity to respond prior to the state registrar amending the death record. If the informant disagrees with the change, marital status and surviving spouse can only be changed upon receipt of an order from a court of competent jurisdiction.

(8) Amendment to other items on the death record:

(a) Signatures may not be amended.

(b) Other personal and statistical items on the death record may be amended by the funeral services practitioner based on a correction affidavit.

(c) Other personal and statistical items on the death record shall be amended by the informant or next of kin only if supported by an affidavit and documentary evidence that is acceptable to the state registrar.

(d) An order from a court of competent jurisdiction may be used to amend any item except signatures, the date of registration, or to amend the date of death to a date that is after the date of registration.

(9) Notwithstanding sections (2) through (7) of this rule, any item may be amended except signatures if the amendment is required because of clerical error by the facility, institution or individual responsible for submitting the report. The request for amendment shall be supported by a written statement explaining the error.

Stat Auth: 2013 OL Ch. 366, Sec. 29

Stats. Implemented: 2013 OL Ch. 366, Sec. 29

Hist.: PH 17-2013, f. 12-26-13, cert. ef. 1-1-14

333-011-0305

Marriage and Oregon Registered Domestic Partnership Records

(1) The state registrar shall register Declaration of Oregon Registered Domestic Partnership forms that have been completed, notarized, and filed with an Oregon county clerk.

(a) The form shall be considered complete when all items not identified as optional or statistical have been completed.

(b) If the item “legal name taken after domestic partnership” is not completed, the form may be accepted for registration. A partner not completing the item will retain the legal name prior to the declaration as their sole legal name.

(2) The state registrar shall register the Application, License, and Record of Marriage forms that have been completed by the officiant and filed with the Oregon county clerk who issued the license.

(a) The form shall be considered complete when all items not identified as statistical have been completed. Affidavit of age may be blank if not required by the county clerk under ORS 109.050.

(b) If the item “legal name taken after marriage” is not completed, the form may be accepted for registration. A party not completing the item will retain the legal name prior to the marriage as their sole legal name.

Stat Auth: 2013 OL Ch. 366, Sec. 22

Stats. Implemented: 2013 OL Ch. 366, Sec. 22

Hist.: PH 17-2013, f. 12-26-13, cert. ef. 1-1-14

333-011-0310

Record of Dissolution

(1) The state registrar shall register Record of Dissolution of Marriage, Annulment or Domestic Partnership forms that have been completed and certified by an Oregon clerk of the court. The form shall be considered complete when the following minimal information has been completed:

(a) Husband/Partner A legal name, date of birth and birthplace;

(b) Wife/Partner B legal name, date of birth and birthplace;

(c) Date of marriage or filing of registered domestic partnership, place of marriage or registered domestic partnership;

(d) Date marriage or registered domestic partnership was dissolved, date judgment becomes effective, county of decree; and

(e) Signature, either physical or electronic, of court official, title of official and date signed.

(2) The clerk of the court shall complete and submit reports of dissolution of marriage or dissolution of domestic partnership for cases where final judgment has been entered on the 5th working day and the 15th working day of each month.

Stat Auth: 2013 OL Ch. 366, Sec. 25

Stats. Implemented: 2013 OL Ch. 366, Sec. 25

Hist.: PH 17-2013, f. 12-26-13, cert. ef. 1-1-14

333-011-0315

Disposition of Reports of Induced Termination of Pregnancy

(1) Reports of induced termination of pregnancy are statistical reports only and are not to be incorporated into the official records of the Vital Statistics Section. The state registrar is authorized to dispose of such reports when all statistical processing of the records has been accomplished. However, the state registrar may establish a file of such records so they will be available for future statistical and research projects provided such file is not made a part of the official records and the reports are not made available for the issuance of certified copies. Such file shall be retained for as long as the state registrar deems necessary and it shall then be destroyed. The file may be maintained by photographic, electronic, or other means as determined by the state registrar, in which case the original report from which the photographic, electronic, or other file was made shall be destroyed.

(2) The provisions of this regulation shall also apply to all records of induced termination of pregnancy filed prior to the adoption of this regulation.

Stat. Auth.: ORS 432.337

Stats. Implemented: ORS 432.337

Hist.: HB 228, f. 11-5-69; HD 24-1981, f. & ef. 11-17-81; Renumbered from 333-011-0110 by PH 17-2013, f. 12-26-13, cert. ef. 1-1-14

333-011-0320

Preservation of Vital Records

(1) When an authorized reproduction of a vital record has been properly prepared by the state registrar and when all steps have been taken to provide for the continued preservation of the information, the record from which such authorized reproduction was made may be disposed of by the state registrar. Such record may not be disposed of until:

(a) The quality of the authorized reproduction has been tested to ensure that acceptable certifications can be issued;

(b) A permanent copy of such record has been placed in a secure location removed from the building where the authorized reproduction is housed; and

(c) The original records have been offered to the State Archives.

(2) Such permanent copy described in section (1) shall be maintained in such a manner to ensure that it can replace the authorized reproduction should the authorized reproduction be lost or destroyed.

(3) The state registrar shall offer the original documents from which the authorized reproductions are made to the State Archives. The State Archives shall retain permanently such records and shall adhere to the restrictions in the vital statistics law related to access to such records. If the State Archives declines to place such records in its files the state registrar shall be authorized to destroy the documents. Such destruction shall be in accordance with generally accepted methods for disposition of confidential or sensitive documents.

(4) Microfilm used for preservation shall be manufactured and stored in accordance with the standards established by the State Archives by rule. Redundant copies shall be stored at one or more sites distant from the master copies. Mechanisms for retrieving copies from distant sites shall be documented and periodically tested.

(5) Electronic images of vital record documents shall be indexed for ease of retrieval. Long-term archiving of electronic documents shall follow standards established by the State Archives by rule. The index shall allow for linking of amended or corrected images to the original image. The images shall be stored in a tamper resistant manner and media. The preservation management program shall include the refreshment of storage media to assure integrity and prevent obsolescence on a periodic basis into new formats as they become accepted.

(6) Vital event information stored as electronic data shall be stored in a manner that is both tamper resistant and tamper evident. All changes to information shall be tracked, including the item changed, the user who made the change, the date of the change, and the justification for the change. Back-ups of electronic data shall be made at regular intervals, and copies shall be stored at one or more sites distant from the master copy. Mechanisms and procedures for retrieving copies from distant sites shall be documented and periodically tested.

(7) The preservation management program shall provide for the periodic refreshment of electronic data, to include hardware, software, and coding standards. The program must include documentation of changes in coding structures, provide for testing of converted files to assure data quality, and address associated costs.

Stat Auth: 2013 OL Ch. 366, Sec. 32

Stats. Implemented: 2013 OL Ch. 366, Sec. 32

Hist.: PH 17-2013, f. 12-26-13, cert. ef. 1-1-14

333-011-0325

Confidentiality and Disclosure of Information from Vital Records or Vital Reports

To protect the confidentiality and security of vital records and vital reports:

(1) The state registrar shall not permit access to or disclosure of personally identifiable information contained in vital records, or issue a copy of all or part of any such record unless the applicant is authorized to obtain such record for a proper purpose under Oregon Laws 2013, chapter 366, section 33, or is authorized to obtain such record under Oregon Laws 2013, chapter 366, section 36.

(a) Access to or disclosure of information contained in vital records for sale or release to the public, for direct or indirect marketing of goods or services, for other non-research solicitation of registrants or families of registrants, or for other commercial or speculative purposes shall not be deemed a proper purpose.

(b) The state registrar may impose reasonable conditions as to the use and re-disclosure of information, and may limit access to the minimum necessary to fulfill the purpose for which information is requested.

(2) Requests for personally identifiable information contained in vital records for health research purposes shall be submitted in writing to the state registrar.

(a) Each request shall contain at a minimum:

(A) Name, title, organizational affiliation and contact information (mailing address, telephone number, and electronic mail address) of the requestor and the organizational official authorized to execute agreements;

(B) Title, objectives and description of the proposed research study;

(C) Institutional Review Board approval of study protocol if any contact with study subjects including children or parents listed on live birth records or next-of-kin or informants of decedents is proposed;

(D) Physical and electronic storage and security measures to be taken to assure confidentiality and security of identifying information, and provision for return or destruction of the information at the conclusion of the research study;

(E) Time frame of the research study;

(F) Names of all persons on the research study team who will have access to the personally identifiable information;

(G) Plan for dissemination of the results.

(b) Each request for personally identifiable information from vital records to be used for health research purposes shall be reviewed to determine compliance with at least the following:

(A) Contains all elements required by this rule;

(B) Adequately justifies the need for the requested information;

(C) Compliance with past data use agreements;

(D) The requested information can be provided within the time frame set forth in the request; and

(E) The state registrar has adequate resources with which to comply with the request.

(3) Requests by government agencies for any identifiable information contained in the state’s vital records maintained pursuant to ORS chapter 432, or for verifications thereof, shall specify in writing the official use to which the requested information will be put and why the information is necessary in accordance with Oregon Laws 2013, chapter 366, section 33. The request may be granted only if the state registrar agrees that the requested information is necessary for a proper purpose.

(a) Each request shall contain at a minimum:

(A) Name, title, agency, and contact information (mailing address, telephone number, and electronic mail address) of the requestor and the agency official authorized to execute agreements;

(B) Purpose or intended use of the data or vital records being requested;

(C) Physical and electronic storage and security measures to be taken to assure confidentiality and security of identifying information, and provision for return or destruction of the information at the conclusion of the intended use;

(D) Time frame of intended use; and

(E) Names of all persons who will have access to the personally identifiable information being requested.

(b) Each request from a government agency for personally identifiable information from vital records shall be reviewed to determine compliance with at least the following:

(A) Contains all elements required by this rule;

(B) Adequately justifies the need for the requested information;

(C) Compliance with past data use agreements;

(D) The requested information can be provided within the time frame set forth in the request; and

(E) The state registrar has adequate resources with which to comply with the request.

(4) The state registrar shall enter into data use agreements for all approved health research and government agency requests for personally identifiable information from vital records. Each data use agreement shall include but not be limited to:

(a) Specification of exactly what information will be disclosed to the requestor, the purpose for which it is provided, and the manner in which the data will be used;

(b) The charges or fees, if any, to be paid by the requestor to the state registrar for use of the data;

(c) A prohibition of re-release by the requestor of any information that may identify any person or any individual case record, whether identifiable or not, without the prior written approval of the state registrar;

(d) The requestor’s acknowledgment and agreement that ownership of all information provided by the state registrar shall remain exclusively that of the state registrar and that the data use agreement constitutes a license to use the data provided only for the purpose and in the manner set forth in the agreement;

(e) The requestor’s agreement neither to attempt to link nor to permit others to attempt to link the data set with individually identifiable records from any other data set without the prior written approval of the state registrar;

(f) The requestor’s agreement neither to use nor to allow anyone else to use the information to attempt to learn the identity of any person included from the information provided without the prior written approval of the state registrar;

(g) Agreement that if the identity of any person is discovered inadvertently, the recipient:

(A) Will not make use of this knowledge;

(B) Will immediately notify the state registrar; and

(C) Will safeguard or destroy the information which led to the identification of the individual as requested by the state registrar;

(h) Acknowledgment and agreement that the requestor shall be responsible for any breach of security, including but not limited to any notifications to affected persons required by law or by the state registrar, and any fines, penalties or other sanctions that may be imposed pursuant to applicable law.

(i) Agreement to prohibit the use of data provided for any purpose not explicitly identified and approved in the signed data use agreement.

Stat Auth: 2013 OL Ch. 366, Sec. 33

Stats. Implemented: 2013 OL Ch. 366, Sec. 33

Hist.: PH 17-2013, f. 12-26-13, cert. ef. 1-1-14

333-011-0330

Authentication of Applicant

(1) An authentication quiz shall be used for each application received by telephone, Internet, or through a kiosk. The authentication quiz shall be based on publicly available information and must be information requiring personal knowledge not available from reviewing current information typically found in a wallet.

(a) For applications received by telephone or Internet, successful completion of the authentication quiz shall serve as identification of the applicant and additional documentation shall not be required.

(b) For applications received by telephone or Internet and the authentication quiz is not successfully completed, the applicant shall be instructed to send additional identity documentation to support the application.

(c) For applications received by kiosk and the authentication quiz is not successfully completed, the applicant must show identification documents before receiving a certified copy in person or by mail.

(2) All applicants applying in person must show identification regardless of authentication quiz completion.

(3) Applicants for records for events occurring more than 50 years for death, fetal death, marriage, Oregon registered domestic partnerships or dissolution of marriage or registered domestic partnerships or 100 years for birth, shall be submitted on the same form and in the same manner, including the authentication quiz, as records for current events.

Stat Auth: 2013 OL Ch. 366, Sec. 36

Stats. Implemented: 2013 OL Ch. 366, Sec. 36

Hist.: PH 17-2013, f. 12-26-13, cert. ef. 1-1-14

333-011-0335

Copies of Vital Records

(1) Full or short form certified copies of vital records may be made by mechanical, electronic, or other reproductive processes, except that the information contained in the “Information for Medical and Health Use Only” section of the record of live birth shall not be included.

(2) When a certified copy is issued, it shall be certified as a true representation of the facts of the event by an authorized agent and shall include the date issued, the name of the state registrar, the state registrar’s signature or an authorized facsimile thereof, and the seal of the state and agency authorized under ORS 432.010.

(3) Confidential verification of the facts contained in a vital record may be furnished by the state registrar to any federal, state, county, or municipal government agency or to any other agency representing the interest of the registrant, subject to the limitations as indicated in section (1) of this rule. Such confidential verifications shall be on forms prescribed and furnished by the state registrar or on forms furnished by the requesting agency and acceptable to the state registrar; or, the state registrar may authorize the verification in other ways when it shall prove in the best interests of his or her office.

(4) The state registrar may authorize certification or verification of fact of death to an institution when the institution has demonstrated to the satisfaction of the state registrar that such information is necessary for a determination of or protection of a personal or property right of the institution.

(5) When the state registrar finds evidence that a record was registered through misrepresentation or fraud, he or she shall have authority to withhold the issuance of a certified copy of such record until a court determination of the facts has been made.

(6) The state registrar shall determine the minimum information needed to locate and identify a particular record within the files.

(7) Subject to the penalties of ORS 432.993, no person is authorized to photograph, photostat, duplicate, or issue what purports to be a certified copy, certification, or record of birth, death, or fetal death except authorized employees of the Public Health Division, county registrars, or their deputies, acting in accordance with directives, regulations, or law governing their official duties.

(8) Certified copies of records of death or records of fetal death issued to an employee or agent of a funeral home or a person acting as a funeral service practitioner shall be transferred only to persons eligible to receive certified copies if applying individually.

(9) The county registrar shall forward any completed original birth records received to the state registrar immediately for registration at the state.

(10) Certified copies of death records used to record the transfer of property in Oregon must not include cause of death information if:

(a) The death occurred after 1977;

(b) The death occurred in Oregon; and

(c) The certified copy is issued after January 1, 2014.

Stat. Auth.: ORS 432.010, 432.085, 432.121 & 432.180

Stats. Implemented: ORS 432.010, 432.085, 432.121 & 432.180

Hist.: HB 169, f. & ef. 10-16-63; HD 24-1981, f. & ef. 11-17-81; HD 3-1986, f. & ef. 2-5-86; PH 16-2011, f. 12-28-11, cert. ef. 1-1-12; Renumbered from 333-011-0101 by PH 17-2013, f. 12-26-13, cert. ef. 1-1-14

333-011-0340

Fees

(1) The fee for a certified copy of a vital statistics record or for an abbreviated birth or death record shall be $20. Additional copies of each record ordered at the same time shall have a fee of $15 per certified copy.

(2) The fee for a Commemorative Certificate of Stillbirth shall be $20. Additional copies of each record ordered at the same time shall have a fee of $15 per certificate.

(3) The fee for any search of the files and records shall be $20. The fee shall include the issuing, when requested, of one certified copy.

(4) The $20 fee shall cover the cost of a five year search for death, marriage and divorce records. If more than a five year search is requested, an additional fee of $1 per year shall be charged.

(5) The fee for a certified copy of a recorded court order registering an unrecorded birth under ORS 432.142, to be furnished by the clerk of the circuit court or the state registrar shall be $20.

(6) Overpayment of a required fee received in the office of the state registrar shall be refunded if in excess of $6 and any overpayment less than $6 shall be refunded upon written request of the applicant within one year.

(7) A fee of $50 shall be paid to the state registrar for the preparation of a new or supplemental record of live birth to amendment, correction, adding the father’s name to the birth record or filing of adoption orders and delayed and court registered birth records. The fee shall include the charge for one certified copy of the new or supplementary record of live birth. If a certified copy is not requested at the time of amendment or creation of the supplementary record, the amendment fee shall be $30.

(a) The $30 amendment fee may be waived to correct an error or omission by a reporting source if a birth record is corrected within the first year from the date of the event.

(b) The $30 amendment fee may be waived at any future time to correct an error on a record of live birth by a reporting source for date of birth, time of birth or gender of registrant.

(8) A fee of $50 shall be paid to the state registrar for the preparation of an amended death record, if amendments are filed more than one year after the date of death. However, no fee shall be paid for amendments to the cause of death filed by the physician or medical examiner that signed the report of death.

(9) A fee of $5.50 shall be paid to expedite the search and filling of an order for a certified copy when the order is placed by telephone or the Internet, billed to a credit card and processed the same or the next working day. This fee is in addition to the fee charged by a subcontractor providing computer, prepayment, billing and collection services for orders processed using the subcontractor’s services.

(10) A fee of $45 shall be paid for heirloom birth certificates.

(11) A fee of $5 per year shall be charged for duplicate copies of microfiche cards containing index information for death, marriage and divorce records.

(12) A fee of $8.50 per reel shall be charged for duplicate copies of microfilm containing index information of death, marriage and divorce records.

(13) Persons requesting special services or specific data sets shall be charged actual time and material costs of producing the data.

(14) The fee for certified copies to be used in research approved by the state registrar shall be $20 for quantities less than 100 certified copies. If the quantity is 100 or more the following scale shall apply:

(a) If a listing is supplied which provides year and state file number, or name, date, and place of event, the fee shall be $10 per copy;

(b) If a listing is supplied which provides name and year of event, the fee shall be $15 per copy;

(c) Listings supplying less information shall be at the regular fee.

(15) A fee of $20 shall be paid for making certified copies of documents from sealed files.

(a) A fee of $20 shall be paid for making certified copies of affidavits and supplemental reports.

(b) A fee of $2 per page shall be charged for uncertified copies of affidavits and supplemental reports that can be issued without opening sealed files.

(16) A fee of $25 may be charged for each check returned for non-payment.

(17) A flat fee of $20 shall be paid for the replacement of certified copies when the original documents are returned within a year of issuance with an acceptable correction document and appropriate amendment fee. This fee may be waived when fewer than four certified copies are being replaced.

(18) A fee of $8 shall be paid for each manual verification of a vital event for each government agency or subdivision of a government agency requesting over 10 verifications per month.

(19) A fee not to exceed $4 shall be paid for each electronic verification of a vital event. This fee is in addition to the fee charged by a subcontractor providing computer system, billing and collection services for verifications processed using the subcontractor’s services.

Stat. Auth.: ORS 432.015, 432.121, 432.146 & 432.266 & 2013 OL Ch. 366, Sec. 3, 33 & 41

Stats. Implemented: ORS 432.146 & 432.266 & 2013 OL Ch. 366, Sec. 3, 33 & 41

Hist.: HB 169, f. & ef. 10-16-63; HD 13-1979(Temp), f. & ef. 10-1-79; HD 18-1979, f. & ef. 12-12-79; HD 2-1985, f. & ef. 2-19-85; HD 1-1987, f. 1-20-87, ef. 2-2-87; HD 10-1990, f. 5-3-90, cert. ef. 7-1-90; HD 4-1992(Temp), f. & cert. ef. 4-28-92; HD 8-1992, f. & cert. ef. 6-22-92; HD 19-1993(Temp), f. & cert. ef. 10-27-93; HD 21-1994, f. & cert. ef. 8-15-94; PH 17-2003, f. 10-31-03, cert. ef. 12-1-03; PH 3-2010, f. & cert. ef. 2-3-10; Renumbered from 333-011-0106 by PH 17-2013, f. 12-26-13, cert. ef. 1-1-14


Rule Caption: Pulse oximetry screening for newborns at hospitals and birthing centers

Adm. Order No.: PH 18-2013(Temp)

Filed with Sec. of State: 12-31-2013

Certified to be Effective: 1-1-14 thru 6-29-14

Notice Publication Date:

Rules Amended: 333-076-0670, 333-520-0060

Subject: The Oregon Health Authority (Authority), Public Health Division is amending rules in chapter 333, divisions 76 and 520 related to pulse oximetry screening for newborns at hospitals and birthing centers. These rules implement SB 172 passed during the 2013 legislative session, which directs the Authority to adopt rules requiring birthing facilities to perform pulse oximetry screening on each newborn delivered at the birthing facility before discharging the newborn. The screening requirement applies to hospitals that provide services related to the delivery of newborns and birthing centers. The rules require hospitals and birthing centers to perform pulse oximetry screening on every newborn born at the facility on or after March 1, 2014, to notify parents and the infant’s health care provider of the results, to provide any necessary follow-up services or treatment in accordance with the applicable standard of care, or provide a referral for such services or treatment, and to document the screening in the infant’s medical record. The screening is to be done in a manner consistent with recommendations published in Strategies for Implementing Screening for Critical Congenital Heart Disease, AR Kemper et al.,Pediatrics 2011;128(5): 1267.

Rules Coordinator: Brittany Sande—(971) 673-1291

333-076-0670

Policies and Procedures

Each Center must have a detailed Policies and Procedures Manual in easily accessible form, that has been approved by the governing body or person. In order to be approved by the Division for licensing purposes, these policies and procedures must meet North American Registry of Midwives (NARM) standards. All the above noted policies must be made available to representatives of the Division on request, and subject to their approval. Failure of approval will be adequate reason for the finding of deficiencies that must be corrected for continuation of licensure. The policies must be implemented as applicable, and there must be documented evidence of implementation of the above noted policies. The policies and procedures that will be developed as applicable and implemented include:

(1) A detailed organizational chart that shows the governing body or person, and clearly delineates lines of authority, responsibility and accountability for each position included in the organization, including volunteers.

(2) Staffing — The governing body or person must ensure, through the policies and procedures, that there are adequate numbers of qualified and, where required, licensed or registered personnel on duty and immediately available to provide services intended for mothers and families, and to provide for safe maintenance of the Center.

(3) Detail of procedures to be permitted, and by whom, and method of determining the qualifications and privileges of all personnel. Staff will be required to provide documented evidence of such qualifications. Such evidence must be maintained by the Center.

(4) System for ensuring 24-hour coverage of the Center, including constant attendance by qualified attendants while a client is in the Center.

(5) System for training and for continuing education for all personnel according to their assigned duties and evaluation of skills consistent with the individual practitioners’ scopes of practice. All personnel providing direct client care must be trained in cardiopulmonary resuscitation (CPR) and there must be a record of current CPR certification. In addition there must be present at each birth one practitioner trained in care and resuscitation of the newborn.

(6) System delineating how and when the Center will seek consultation with clinical specialists in obstetrics and pediatrics in order to ensure that all services, policies, and procedures meet North American Registry of Midwives (NARM) standards.

(7) Protocol for referral or transfer to appropriate health care facilities all clients whose risk status exceeds that for “low risk pregnancy.”

(8) Procedures by which risk status will be assessed during the antepartal, intrapartal, and post partum period, and the identification of medical and social factors which exclude women, fetuses and newborns from the low-risk group; and for the annual review of these methods. Documentation of such assessments must be maintained in client’s clinical records. Only those clients for whom prenatal and intrapartum history, physical examination, and laboratory screening procedures have demonstrated a low risk pregnancy and labor will be accepted into the Center for childbirth.

(9) System by which the Center will ensure the presence and continuing maintenance, as recommended by the manufacturer(s), of equipment needed to provide low risk maternity care, and to initiate emergency procedures in life-threatening events to the mother or baby.

(10) Plan and protocols for ensuring that emergency situations in either the mother or newborn are recognized in a timely fashion, and care is provided within the limits of the practitioner’s scope of practice.

(11) System delineating how emergency transportation will be promptly available for transport of the mother and/or newborn to a health care facility with the capacity for emergency care of women, in all the stages of labor, and newborns. The written policy must include a listing of situations for the mother and/or newborn that would have the potential to necessitate emergency transfer. The policy must also include the requirement that a transfer plan for each patient be developed.

(12) Systems for ensuring the orientation and education of women and families registering for care at the Center so that they will be informed as to the benefits and risks of the services available to them at the Center and the qualifications and licensure status of practitioners at the Center. They must be fully informed of the risk criteria as defined in OAR 333-076-0650 and provide written consent. The client, as a part of the informed consent, must also agree in advance to transfer to another clinician or appropriate health care facility, should the need occur due to the development of unexpected risk factors after admission to the Center. The client must be informed of the benefits and risks of such a transfer.

(13) System for the sterilization of equipment and supplies, unless only pre-packaged and pre-sterilized items are used.

(14) System to ensure the performance of appropriate laboratory studies and to ensure that the results are available in a timely manner.

(15) System for the storage and administration of drugs. All medications must be prescribed and/or administered within the individual practitioner’s licensure and/or scope of practice.

(16) System to ensure the timely administration of Rh immune globulin to the mother, where applicable.

(17) System to ensure the timely appropriate administration of Vitamin K to the newborn, according to rules of the Division.

(a) The purpose of ORS 433.303 to 433.314 is to protect newborn infants against hemorrhagic disease of the newborn.

(b) The Vitamin K forms suitable for use are forms of Vitamin K1 (Phytonadione), available in injectable or oral forms: as Mephyton for oral use, or as aquamephyton or konakion for injectable use. The Vitamin K dose is to be administered within the first 24 hours of delivery. Menadione (Vitamin K3) is not recommended for prophylaxis and treatment of hemorrhagic disease of the newborn.

(c) The dose of any of the Vitamin K1 forms to be administered is one dose of 0.5 to 1.0 mg., if given by injection, or one dose of 1.0 to 2.0 mg. if given orally.

(d) A parent may, after being provided a full and clear explanation, decline to permit the administration of Vitamin K based on religious tenets and practices. In this event, the parent must sign a form acknowledging his/her understanding of the reason for administration of Vitamin K and possible adverse consequences in the presence of a person who witnessed the instruction of the parent, and who must also sign the form. The form must become a part of the clinical record of the newborn infant.

(18) System to ensure the timely and appropriate collection of blood from the newborn for testing by the State Laboratory, Newborn Screening Program, for the Metabolic Diseases listed in 333-024-0210.

(19) System to ensure that pulse oximetry screening is performed on every newborn infant delivered at the birthing center on and after March 1, 2014, before discharging the newborn infant. Screening should be done in a manner consistent with the recommendations found in Strategies for Implementing Screening for Critical Congenital Heart Disease, AR Kemper et al., Pediatrics 2011;128(5): e1259–1267.

(a) A center must have policies and procedures or protocols based on nationally recognized recommendations for newborn infant pulse oximetry screening and follow-up care, for determining what is considered a positive screen result and the follow-up services, treatment, or referrals that must be provided if a newborn infant has a positive screen result.

(b) In addition, there must be a system to ensure that:

(A) The health care provider responsible for the newborn infant and the infant’s primary care provider are notified of the results of the screening;

(B) The parent or legal representative of the newborn infant is notified of the results of the screening;

(C) In accordance with the applicable standard of care, any appropriate follow-up services or treatment for the newborn infant is provided, if necessary; or that a referral to a parent or legal representative of the newborn infant is provided for follow-up services or treatment if necessary; and

(D) There is documentation in the infant’s medical record that screening was performed, the results, the names of the health care providers who were notified of the results, and any follow-up services or treatment or referral for services or treatment.

(c) A parent or legal representative of a newborn infant may decline testing and if testing is declined the declination must be documented in the medical record.

(20) Protocol delineating the steps to ensure the prompt and safe evacuation of the Center in the event of emergency situations, such as fire. The Center must ensure the evaluation of staff in managing such situations by periodic drills for fire, and/or other emergencies. Such drills must be documented.

(21) System of infection control to address the prevention and early recognition of the possibility of infection, and timely and acceptable methods of control. This includes written documentation of the problem, and measures taken for control, and must at least meet the requirements of the rules of the Division. Documentation must also include methods for the control and prevention of cross-infection between clients and services in accordance with 2003 Center for Disease Control and Prevention “Guidelines for Environmental Infection Control in Health-Care Facilities.”

(22) System to be used for the prevention of Ophthalmia Neonatorum in the newborn OAR 333-019-0036(2). Prophylaxis for Gonococcal Ophthalmia Neonatorum:

(a) The practitioner attending the birth of an infant must, after evaluating the infant as being at risk and within two hours of delivery, instill appropriate prophylactic antibiotic ointment from single patient use applicators into each eye of the newborn infant;

(b) Parent(s) refusing to allow prophylaxis for their infant(s) must be informed, by the attending Health Care Provider, of the risks attendant to such action and must sign a witnessed affidavit to testify that they have been so informed and nonetheless refuse to allow prophylaxis.

(c) If Vitamin K and/or Gonococcal Ophthalmia Neonatorum Prophylaxis cannot be administered by the individual delivering the newborn, methods must be described to ensure that these services are arranged by referral.

(23) System to ensure that appropriate vital records are filed according to the rules of the Division.

(24) System for a semi-annual clinical record audit to evaluate the care process and outcome.

Stat. Auth.: ORS 441.025 & 442.015

Stats. Implemented: ORS 441.025 & 442.015

Hist.: HD 26-1985, f. & ef. 10-28-85; HD 2-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0420; PH 15-2006, f. & cert. ef. 6-27-06; PH 18-2013(Temp), f. 12-31-13, cert. ef. 1-1-14 thru 6-29-14

333-520-0060

Maternity Services

(1) General hospitals are required to comply with this rule. A low occupancy acute care hospital shall comply with this rule if it offers maternity services.

(2) A hospital that provides maternity services shall have separate maternity facilities and a maternity care department that:

(a) Has labor, delivery, recovery, postpartum, and nursery rooms that conform to the applicable requirements of OAR chapter 333, division 535;

(b) Requires every person in the delivery room during a delivery to be appropriately attired according to the hospital’s Infection Control Policy;

(c) Has appropriate resuscitation equipment immediately available to rooms where deliveries are planned and where newborn infants are kept;

(d) Has a warmed blanket or incubator for newborns to prevent thermal loss;

(e) Has incubators for premature infants equipped with a governor to control the flow of oxygen at 40 percent or under, and an oxygen analyzer;

(f) Has an accurate scale for weighing of infants; and

(g) Includes a nursery and a separate bassinet for each infant with a clean mattress covered with suitable sheeting, washable pads, and bed linen that is kept clean at all times.

(3) A health care practitioner attending the birth of a newborn shall evaluate and treat a newborn at risk for chlamydial or gonococcal ophthalmia neonatorum in accordance with OAR 333-019-0036.

(4) A parent or legal representative that refuses to allow prophylaxis for an infant shall be informed by the attending health care practitioner of the risks of the refusal and must sign a witnessed affidavit that attests they have been so informed and nonetheless refuse to allow prophylaxis.

(5) A hospital shall ensure that all newborns are given Vitamin K at birth as required by ORS 433.303 through 433.314.

(a) A physician or midwife attending the mother at the birth of the child shall be responsible for ensuring that the newborn infant receives Vitamin K within 24 hours of birth to protect the infant against hemorrhagic disease of the newborn.

(b) The Vitamin K forms suitable for use are:

(A) Vitamin K 1 (Phytonadione) for oral or injectable use;

(B) Mephyton for oral use; or

(C) Aquamephyton or konakion for injectable use.

(c) A parent may, after being provided a full and clear explanation, decline to permit the administration of Vitamin K based on religious tenets and practices. If a parent or legal representative declines Vitamin K, the parent shall sign a form acknowledging his or her understanding of the reason for administration of Vitamin K and possible adverse consequences in the presence of a person who witnessed the instruction of the parent, who shall also sign the form. The form shall become a part of the medical record of the newborn infant.

(6) A hospital shall ensure that every newborn infant born in the hospital is tested for Metabolic Diseases as required by OAR 333-024-0210 through 333-024-0235 and instructions to the parents or legal representative regarding the testing that be documented in the medical record.

(7) A hospital shall ensure that every newborn infant born in the hospital receives a Newborn Hearing Screening Test as required by ORS 433.321 and OAR chapter 333, division 020.

(8) On and after March 1, 2014, a hospital must perform pulse oximetry screening on every newborn infant delivered at the hospital before discharging the newborn infant. Screening should be done in a manner consistent with the recommendations found in Strategies for Implementing Screening for Critical Congenital Heart Disease, AR Kemper et al.,Pediatrics 2011;128(5): e1259–1267.

(a) A hospital must have policies and procedures or protocols based on nationally recognized recommendations for newborn infant pulse oximetry screening and follow-up care, for determining what is considered a positive screening result and the follow-up services, treatment, or referrals that must be provided if a newborn infant has a positive screening result.

(b) Following the screening a hospital must:

(A) Notify the health care provider responsible for the newborn infant and the infant’s primary care provider of the results of the screening;

(B) Notify a parent or legal representative of the newborn infant of the results of the screening;

(C) In accordance with the applicable standard of care, provide any appropriate follow-up services or treatment for the newborn infant if necessary or provide a referral to a parent or legal representative of the newborn infant for follow-up services or treatment if necessary; and

(D) Document in the newborn infant’s medical record that the screening was performed, the results, the names of the health care providers who were notified of the results, and any follow-up services or treatment or referral for services or treatment.

(c) A parent or legal representative of a newborn infant may decline testing and if testing is declined, the declination must be documented in the medical record.

(9) Every infant born in a hospital shall be marked for identification before the infant is removed from the place of delivery and such identification shall not be removed from the infant until the infant is discharged.

(10) A hospital shall not admit visitors to a delivery room, maternity rooms, wards, units, or the nursery except in accordance with the hospital’s visiting policy.

(11) A hospital shall ensure that persons entering the nursery are attired according to the hospital infection control policy and that hands are washed before touching an infant.

(12) A hospital shall follow its infection control policy when handling and storing linens.

(13) Formula feedings and any other feedings shall be given only as prescribed in writing by the physician or certified nurse midwife.

(14) A hospital shall maintain and preserve a log of births giving date of birth, name of newborn, and mother’s name and chart number, in addition to complying with the requirements of the Authority’s Center for Health Statistics.

(15) A hospital may use a part of the maternity department for selected, non-communicable non-obstetrical patients as defined by hospital policy and approved by the hospital’s infection control program under the following conditions:

(a) Patients admitted or transferred to the maternity department shall be instructed by appropriate maternity service personnel as to their responsibilities regarding use of the facility.

(b) Patients admitted to the maternity department shall be limited to obstetrical patients admitted for delivery, patients with obstetric complications, and selected non-communicable, non-obstetrical patients.

(c) Obstetrical patients and medical/surgical patients shall not occupy the same room.

(d) If necessary, one or more medical/surgical patients shall be transferred to another service in order to admit obstetrical patients.

(16) A hospital shall adhere strictly to the guidelines for standard precautions developed by the Hospital Infection Control Practices Advisory Committee (HICPAC) when caring for obstetrical patients with infectious conditions. Patients with infectious conditions requiring strict isolation according to the above guidelines shall be transferred out of the maternity department following delivery, and given care in an area of the hospital where that isolation can be provided. If a maternity patient is found to have an infectious condition during surgery or delivery, the patient shall be returned to the maternity department and isolated according to hospital infection control policy.

(17) A delivery room suite may be used for surgical procedures on non-obstetrical patients if approved by the Chief of Obstetrics in accordance with medical staff rules and regulations.

(18) A hospital with maternity services may place stable postpartum patients and stable newborns, as those terms are defined in OAR 333-500-0010, on another acute care unit on a periodic basis under the following conditions:

(a) When a postpartum patient or newborn to be transferred out of the OB unit meet the hospital’s criteria for care on another unit as described in this rule;

(b) Where the decision to place a postpartum patient or newborn on another unit is based on currently accepted postpartum and newborn care standards and the ability of that unit to meet the needs of the patient; and

(c) When nursing staff on the non-OB unit have received training required by this rule and have demonstrated continuing competence.

(19) A hospital that provides care to postpartum patients and newborns on non-OB units shall:

(a) Develop and implement policies and procedures that include but are not limited to:

(A) The transfer of postpartum patients and newborns to non-OB units including a delineation of the authority for medical, clinical and administrative nursing staff, and, when applicable, nurse practitioner staff to make the decision;

(B) Staffing guidelines for the nursing care of postpartum patients and newborns on the non-OB unit;

(C) Provision of information to maternity patients of possible or intended placement on a non-OB unit;

(D) Provision of consumer information related to the availability and location of specialty maternity services;

(E) Infection control practices including the use of standard precautions;

(F) Procedures for patient placement, privacy, and safety that prohibit postpartum patients and newborns from occupying the same room as non-obstetrical patients;

(G) Protocols for the placement of newborns without mothers;

(H) Procedures to assure the inclusion of the care of postpartum patients and newborns on non-OB units in the hospital’s quality assurance program; and

(I) Delineation of hospital protocols for the return of postpartum patients and newborns to the OB unit, including addressing situations when safe care can no longer be provided on the non-OB unit.

(b) Develop and implement staff training, continuing education, and continuing competency program that includes but is not limited to:

(A) Postpartum nursing care;

(B) Nursing care of the newborn;

(C) Newborn resuscitation;

(D) Newborn feeding;

(E) Maternal and family education;

(F) Infection control practices including the use of standard precautions; and

(G) Maternity services policies and procedures including those required in subsection (19)(a) of this rule.

Stat. Auth.: ORS 441.055

Stats. Implemented: ORS 441.055 & 442.015

Hist.: HB 183, f. & ef. 5-26-66; HB 209, f. 12-18-68; HB 252, f. 7-22-70, ef. 8-25-70; HD 25, f. 10-20-72, ef. 11-1-72; HD 72, f. 11-7-74, ef. 12-11-74; HD 7-1979, f. & ef. 7-17-79; HD 11-1980, f. & ef. 9-10-80; Renumbered from 333-023-0126; HD 29-1988, f. 12-29-88, cert. ef. 1-1-89, Renumbered from 333-072-0005(12), (13), & (14); HD 21-1993, f. & cert. ef. 10-28-93; HD 30-1994, f. & cert. ef. 12-13-94; HD 2-2000, f. & cert. ef. 2-15-00; OHD 3-2001, f. & cert. ef. 3-16-01; PH 11-2009, f. & cert. ef. 10-1-09; PH 17-2012, f. 12-20-12, cert. ef. 1-1-13; PH 18-2013(Temp), f. 12-31-13, cert. ef. 1-1-14 thru 6-29-14


Rule Caption: Updating rules for Medical Marijuana pertaining to registration fees and adding a new medical condition

Adm. Order No.: PH 1-2014

Filed with Sec. of State: 1-13-2014

Certified to be Effective: 1-13-14

Notice Publication Date: 12-1-2013

Rules Amended: 333-008-0010, 333-008-0020, 333-008-0045

Rules Repealed: 333-008-0020(T)

Subject: The Oregon Health Authority, Public Health Division, Oregon Medical Marijuana Program (OMMP) is permanently amending OAR 333-008-0010 relating to a new medical condition, and OAR 333-008-0020 and 333-008-0045 relating to registration for medical marijuana use.

   In 2013 the Legislature approved medical marijuana fee reductions for individuals that are eligible for Oregon Health Plan (OHP) benefits or are receiving food stamp benefits through the Oregon SNAP program. In addition, the passage of SB 281 added Post Traumatic Stress Disorder (PTSD) as a new medical condition. The fee reductions were implemented beginning October 1, 2013 with a temporary rulemaking that expires on March 30, 2014. This rulemaking will make those fee changes in rule permanent.

   The Oregon Medical Marijuana Act (OMMA) mandates the Authority to adopt a fee structure in rule. In order to comply with the OMMA and legislative direction, the OMMP must amend its rules to reduce the application fee for OHP clients and SNAP recipients, and to add PTSD as a qualifying medical condition. Additionally, the Authority is simplifying the proof of residency requirements for those individuals submitting a reduced application fee, and clarifying that the replacement card fee is non-refundable in order to be consistent with other fees.

Rules Coordinator: Brittany Sande—(971) 673-1291

333-008-0010

Definitions

For the purposes of OAR 333-008-0000 through 333-008-0120, the following definitions apply:

(1) “Act” means the Oregon Medical Marijuana Act.

(2) “Applicant” means a person applying for an Oregon Medical Marijuana registry identification card on a form prescribed by the Authority.

(3) “Attending physician” means a Doctor of Medicine (MD) or Doctor of Osteopathy (DO), licensed under ORS Chapter 677, who has primary responsibility for the care and treatment of a person diagnosed with a debilitating medical condition.

(4) “Authority” means the Oregon Health Authority.

(5) “Debilitating medical condition” means:

(a) Cancer, glaucoma, agitation incident to Alzheimer’s disease, positive status for human immunodeficiency virus or acquired immune deficiency syndrome, or a side effect related to the treatment of these medical conditions;

(b) A medical condition or treatment for a medical condition that produces, for a specific patient, one or more of the following:

(A) Cachexia;

(B) Severe pain;

(C) Severe nausea;

(D) Seizures, including but not limited to seizures caused by epilepsy; or

(E) Persistent muscle spasms, including but not limited to spasms caused by multiple sclerosis;

(c) Post-traumatic stress disorder; or

(d) Any other medical condition or side effect related to the treatment of a medical condition adopted by the Authority by rule or approved by the Authority pursuant to a petition submitted under OAR 333-008-0090.

(6) “Delivery” means the actual, constructive or attempted transfer, other than by administering or dispensing, from one person to another of a controlled substance, whether or not there is an agency relationship, but does not include transfer of marijuana from one patient to another patient if no consideration is paid for the transfer.

(7) “Designated primary caregiver” means an individual 18 years of age or older who has significant responsibility for managing the well-being of a person who has been diagnosed with a debilitating medical condition and who is designated as such on that person’s application for a registry identification card or in other written notification to the Authority. “Designated primary caregiver” does not include the person’s attending physician.

(8) “Food stamps” means the Supplemental Nutrition Assistance Program as defined and governed by ORS 411.806 through 411.845.

(9) “Grow site” means a specific location used by the grower to produce marijuana for medical use by a specific patient.

(10) “Grow site registration card” means the card issued to the patient and displayed at the grow site.

(11) “Grower” has the same meaning as “person responsible for a marijuana grow site.”

(12) “Immature plant” has the same meaning as “seedling or start.”

(13) “Marijuana” means all parts of the plant Cannabis family Moraceae, whether growing or not; the resin extracted from any part of the plant; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant or its resin. It does not include the mature stalks of the plant, fiber produced from the stalks, oil or cake made from the seeds of the plant, any other compound, manufacture, salt, derivative, mixture, or preparation of the mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of the plant which is incapable of germination.

(14) “Mature plant” means a marijuana plant that does not fall within the definition of a seedling or a start.

(15) “Medical use of marijuana” means the production, possession, delivery, or administration of marijuana, or paraphernalia used to administer marijuana, as necessary for the exclusive benefit of a person to mitigate the symptoms or effects of his or her debilitating medical condition.

(16) “Oregon Health Plan (OHP)” means the medical assistance program administered by the Authority under ORS chapter 414.

(17) “OMMP” refers to the office within the Authority that administers the provisions of the OMMA, and all policies and procedures pertaining thereto, as set forth in these rules.

(18) “Parent or legal guardian” means the custodial parent or legal guardian with responsibility for health care decisions for the person under 18 years of age.

(19) “Patient” has the same meaning as “registry identification cardholder.”

(20) “Person responsible for a marijuana grow site” means a person who has been selected by a patient to produce medical marijuana for the patient, and who has been registered by the Authority for this purpose.

(21) “Primary responsibility” as that term is used in relation to an attending physician means that the physician:

(a) Provides primary health care to the patient; or

(b) Provides medical specialty care and treatment to the patient as recognized by the American Board of Medical Specialties; or

(c) Is a consultant who has been asked to examine and treat the patient by the patient’s primary care physician licensed under ORS chapter 677, the patient’s physician assistant licensed under ORS chapter 677, or the patient’s nurse practitioner licensed under ORS chapter 678; and,

(d) Has reviewed a patient’s medical records at the patient’s request and has conducted a thorough physical examination of the patient, has provided or planned follow-up care, and has documented these activities in the patient’s medical record.

(22) “Production” includes the manufacture, planting, cultivation, growing or harvesting of a controlled substance.

(23) “Registry identification card” means a document issued by the Authority that identifies a person authorized to engage in the medical use of marijuana, and the person’s designated primary caregiver, if any.

(24) “Registry identification cardholder” means a person who has been diagnosed by an attending physician with a debilitating medical condition and for whom the use of medical marijuana may mitigate the symptoms or effects of the person’s debilitating medical condition, and who has been issued a registry identification card by the Authority.

(25) “Replacement registry identification card” means a new card issued in the event that a registry identification cardholder’s card, designated primary caregiver identification card, grower identification card, or grow site registration card is lost or stolen, or if a registry identification cardholder’s designation of primary caregiver, grower, or grow site has changed.

(26) “Seedling or start” means a marijuana plant that has no flowers, is less than 12 inches in height, and less than 12 inches in diameter. A seedling or start that does not meet all three criteria shall be considered a mature plant.

(27) “Supplemental Security Income (SSI)” means the monthly benefit assistance program administered by the federal government for persons who are age 65 or older, or blind, or disabled and who have limited income and financial resources.

(28) “Usable marijuana” means the dried leaves and flowers of the plant Cannabis family Moraceae and any mixture or preparation thereof, that are appropriate for medical use. “Usable marijuana” does not include the seeds, stalks and roots of the plant.

(29) “Written documentation” means a statement signed and dated by the attending physician of a person diagnosed with a debilitating medical condition or copies of the person’s relevant medical records, maintained in accordance with standard medical record practices.

Stat. Auth.: ORS 475.338

Stats. Implemented: ORS 475.300 - 475.346

Hist.: OHD 15-1998(Temp), f. & cert. ef. 12-24-98 thru 6-22-99; OHD 3-1999, f. & cert. ef. 4-29-99; OHD 13-2000(Temp), f. & cert. ef. 12-21-00 thru 6-15-01; OHD 18-2001, f. & cert. ef. 8-9-01; OHD 19-2001(Temp), f. & cert. ef. 8-10-01 thru 1-31-02; Administrative correction 3-14-02; OHD 6-2002, f. & cert. ef. 3-25-02; PH 9-2003, f. 6-26-03, cert. ef. 7-1-03; PH 18-2005, f. 12-30-05, cert. ef. 1-1-06; PH 15-2007, f. 12-19-07, cert. ef. 1-1-08; PH 21-2010, f. & cert. ef. 9-13-10; PH 5-2011(Temp), f. & cert. ef. 7-1-11 thru 12-27-11; PH 8-2011, f. 9-30-11, cert. ef. 10-1-11; PH 1-2014, f. & cert. ef. 1-13-14

333-008-0020

New Registration Application and Verification

(1) A person may apply for a registry identification card on forms prescribed by the Authority. In order for an application to be considered complete, an applicant must submit the following:

(a) An application form signed and dated by the applicant;

(b) Copies of legible and valid U.S. state or federal issued photographic identification that includes last name, first name, and date of birth from the applicant, the designated primary caregiver, and grower, as applicable. Acceptable forms of current U.S. state or federal issued photographic identification include but are not limited to:

(A) Driver’s license;

(B) State identification card;

(C) Passport; or

(D) Military identification card.

(c) Written documentation, which may consist of relevant portions of the applicant’s medical record, signed by the applicant’s attending physician within 90 days of the date of receipt by the Authority, which describes the applicant’s debilitating medical condition and states that the use of marijuana may mitigate the symptoms or effects of the applicant’s debilitating medical condition;

(d) If applicable, a completed and notarized “Declaration of Person Responsible for Minor” form for any person under 18 years of age, signed and dated by the person responsible for the minor;

(e) The name of a designated primary caregiver, if any, and one designated grower (either the patient or another person) and the location of the grow site; and

(f) An application fee and grow site registration fee, if applicable, in the form of cash, bank check, money order, or personal check.

(2) The Authority shall process an application prior to issuing registry identification cards to assure that the application is complete and information provided has been verified.

(a) The Authority shall only accept applications that are mailed or are hand-delivered.

(b) If an applicant does not provide all the information required and the application is considered incomplete, the Authority shall notify the applicant of the information that is missing, and shall allow the applicant 14 days to submit the missing information.

(c) If an applicant does not provide the information necessary to declare an application complete, or to complete the verification process within the timelines established in subsections (2)(b) and (3)(e) of this rule, the application shall be rejected as incomplete. An applicant whose application is rejected as incomplete may reapply at any time. If an applicant submits an application fee and the application is subsequently denied or rejected, the application fee may be applied toward a new application submitted within one year of the denial or rejection date.

(d) The Authority may reject an application if the application or supporting documents appear to be altered (for example, writing is whited out). An application shall be denied in accordance with OAR 333-008-0030 if an application or supporting documents are determined to have been falsified.

(e) The Authority may verify information on each application and accompanying documentation, including:

(A) Contacting each applicant by telephone or by mail. If proof of identity is uncertain, the Authority may require a face-to-face meeting and may require the production of additional identification materials;

(B) Contacting a minor’s parent or legal guardian;

(C) Contacting the Oregon Medical Board to verify that an attending physician is licensed to practice in the state and is in good standing;

(D) Contacting the attending physician to request further documentation to support a finding that the physician is the applicant’s attending physician. The Authority shall notify the applicant of the intent to review the medical records and request the applicant’s authorization to conduct the review. Failure to authorize a review of medical records may result in the application being declared incomplete, or denial of an application. If the Authority is unable to verify that the applicant’s attending physician meets the definition under OAR 333-008-0010(3) the applicant will be allowed 30 days to submit written documentation or a new attending physician’s declaration from a physician meeting the requirements of these rules. Failure to submit the required attending physician documentation is grounds for denial under ORS 475.309 and OAR 333-008-0030;

(E) Contacting the Division of Medical Assistance Programs, Department of Human Services-Self Sufficiency, or the Social Security Administration (SSA) to verify eligibility for benefits; and

(F) Conducting a criminal records check under ORS 181.534 of any person whose name is submitted as a grower.

(3) Application fees.

(a) A non-refundable application fee of $200 is required at the time of application.

(b) If applicable as specified in OAR 333-008-0025, a non-refundable grow site registration fee of $50 is required at the time of application.

(c) An applicant who can demonstrate current receipt of SSI benefits, current eligibility for OHP benefits or current receipt of food stamp benefits through the Oregon SNAP program qualifies for a reduced non-refundable application fee.

(A) An applicant demonstrating receipt of SSI benefits by providing a copy of a current monthly SSI benefit card showing dates of coverage is entitled to a reduced application fee of $20.

(B) An applicant demonstrating current eligibility for OHP benefits by providing a copy of the applicant’s current eligibility statement is entitled to a reduced application fee of $50.

(C) An applicant demonstrating receipt of current food stamp benefits, verified by enrollment in Oregon’s Food Stamp Management Information System database system and by providing current proof of his or her food stamp benefits, is entitled to a reduced application fee of $60.

(d) The Authority shall place a 10-day hold on the issuance of a registry identification card for an application accompanied by a personal check. Upon receipt by the Authority of a notice of non-sufficient funds (NSF) or stop payment, an applicant will be allowed 14 days to submit payment in the form of a bank check or cash. Application fees paid in the form of cash must be hand-delivered. Applicants are advised not to make payments in cash through the United States mail or private delivery services. The Authority will not accept responsibility for payments of cash that are lost in the mail or stolen in transit.

(e) The Authority shall notify an applicant who submits a reduced application fee for which the applicant is not eligible and will allow the applicant 14 days from the date of notice to pay the correct application fee and submit a current valid proof of eligibility.

(f) The application fees established in paragraphs (3)(c)(B) and (C) of this rule are effective for applications received on or after October 1, 2013.

(4) The application forms referenced in this rule may be obtained by contacting the Oregon Medical Marijuana Program (OMMP) at PO Box 14450, Portland, OR 97293-0450 or by calling 971-673-1234.

Stat. Auth.: ORS 475.338

Stats. Implemented: ORS 475.300 - 475.346

Hist.: OHD 3-1999, f. & cert. ef. 4-29-99; OHD 13-2000(Temp), f. & cert. ef. 12-21-00 thru 6-15-01; OHD 18-2001, f. & cert. ef. 8-9-01; OHD 19-2001(Temp), f. & cert. ef. 8-10-01 thru 1-31-02; Administrative correction 3-14-02; OHD 6-2002, f. & cert. ef. 3-25-02; PH 9-2003, f. 6-26-03, cert. ef. 7-1-03; PH 38-2004, f. 12-22-04, cert. ef. 1-1-05; PH 17-2005, f. 11-25-05, cert. ef. 12-1-05; PH 18-2005, f. 12-30-05, cert. ef. 1-1-06; PH 15-2007, f. 12-19-07, cert. ef. 1-1-08; PH 14-2010(Temp), f. & cert. ef. 7-6-10 thru 12-31-10; PH 27-2010, f. & cert. ef. 12-28-10; PH 8-2011, f. 9-30-11, cert. ef. 10-1-11; PH 9-2013(Temp), f. & cert. ef. 10-2-13 thru 3-30-14; PH 1-2014, f. & cert. ef. 1-13-14

333-008-0045

Interim Changes

(1) A patient shall notify the Authority within 30 calendar days of any change in the patient’s name, address, telephone number, attending physician, designated primary caregiver, grower or grow site address.

(2) A patient shall notify the designated primary caregiver and the grower of any changes in status including, but not limited to:

(a) The assignment of another individual as the designated primary caregiver for the patient;

(b) The assignment of another individual as a grower for the patient; or

(c) The end of eligibility of the patient to hold a registry identification card.

(3) If the Authority is notified by the patient that a designated primary caregiver or a grower has changed, the Authority shall notify the designated primary caregiver or the grower by mail at the address of record confirming the change in status and informing the caregiver or grower that their card is no longer valid and must be returned to the Authority within seven calendar days.

(4) A patient who has been diagnosed by an attending physician as no longer having a debilitating medical condition or whose attending physician has determined that the medical use of marijuana is contraindicated for the patient’s debilitating medical condition shall return the registry identification card and all associated OMMP cards to the Authority within 30 calendar days of notification of the diagnosis or notification of the contraindication. If, due to circumstances beyond control of the patient he or she is unable to obtain a second medical opinion about the patient’s continuing eligibility to use medical marijuana before the 30-day period has expired, the Authority may grant the patient additional time to obtain a second opinion before requiring the patient to return the registry identification card and all associated cards.

(5) Change forms may only be submitted to the Authority via mail or in person at the OMMP office.

(6) If a patient’s designated primary caregiver, grower or grow site has changed, the non-refundable fee to receive a replacement card is $100. If the patient qualifies for the reduced application fee of $20, the non-refundable fee to receive a replacement card is $20.

(7) If a patient is registering a new grow site at any time other than when submitting a new application or a renewal application, a grow site registration fee will not be charged.

Stat. Auth.: ORS 475.309 & 475.312

Stats. Implemented: ORS 475.309 & 475.312

Hist.: PH 27-2010, f. & cert. ef. 12-28-10; PH 8-2011, f. 9-30-11, cert. ef. 10-1-11; PH 1-2014, f. & cert. ef. 1-13-14


Rule Caption: Medical Marijuana Facilities

Adm. Order No.: PH 2-2014(Temp)

Filed with Sec. of State: 1-14-2014

Certified to be Effective: 1-15-14 thru 7-13-14

Notice Publication Date:

Rules Adopted: 333-008-1000, 333-008-1010, 333-008-1020, 333-008-1030, 333-008-1040, 333-008-1050, 333-008-1060, 333-008-1070, 333-008-1080, 333-008-1090, 333-008-1100, 333-008-1110, 333-008-1120, 333-008-1130, 333-008-1140, 333-008-1150, 333-008-1160, 333-008-1170, 333-008-1180, 333-008-1190, 333-008-1200, 333-008-1210, 333-008-1220, 333-008-1230, 333-008-1240, 333-008-1250, 333-008-1260, 333-008-1270, 333-008-1280, 333-008-1290

Rules Amended: 333-008-0010, 333-008-0020, 333-008-0025, 333-008-0045, 333-008-0050, 333-008-0120

Subject: The Oregon Health Authority (Authority), Public Health Division is temporarily amending and adopting administrative rules in chapter 333, division 8 pertaining to medical marijuana facilities. HB 3460 was passed during the 2013 legislative session directing the Authority to establish by rule a medical marijuana facility registration system to authorize the transfer of usable marijuana and immature marijuana plants. The rules also establish fees for applying and registering and renewing registration for a medical marijuana facility.

Rules Coordinator: Brittany Sande—(971) 673-1291

333-008-0010

Definitions

For the purposes of OAR 333-008-0000 through 333-008-0120, the following definitions apply:

(1) “Act” means the Oregon Medical Marijuana Act.

(2) “Applicant” means a person applying for an Oregon Medical Marijuana registry identification card on a form prescribed by the Authority.

(3) “Attending physician” means a Doctor of Medicine (MD) or Doctor of Osteopathy (DO), licensed under ORS Chapter 677, who has primary responsibility for the care and treatment of a person diagnosed with a debilitating medical condition.

(4) “Authority” means the Oregon Health Authority.

(5) “Debilitating medical condition” means:

(a) Cancer, glaucoma, agitation incident to Alzheimer’s disease, positive status for human immunodeficiency virus or acquired immune deficiency syndrome, or a side effect related to the treatment of these medical conditions;

(b) A medical condition or treatment for a medical condition that produces, for a specific patient, one or more of the following:

(A) Cachexia;

(B) Severe pain;

(C) Severe nausea;

(D) Seizures, including but not limited to seizures caused by epilepsy; or

(E) Persistent muscle spasms, including but not limited to spasms caused by multiple sclerosis;

(c) Post-traumatic stress disorder; or

(d) Any other medical condition or side effect related to the treatment of a medical condition adopted by the Authority by rule or approved by the Authority pursuant to a petition submitted under OAR 333-008-0090.

(6) “Delivery” means the actual, constructive or attempted transfer, other than by administering or dispensing, from one person to another of a controlled substance, whether or not there is an agency relationship, but does not include transfer of marijuana from one patient to another patient if no consideration is paid for the transfer.

(7) “Designated primary caregiver” means an individual 18 years of age or older who has significant responsibility for managing the well-being of a person who has been diagnosed with a debilitating medical condition and who is designated as such on that person’s application for a registry identification card or in other written notification to the Authority. “Designated primary caregiver” does not include the person’s attending physician.

(8) “Food stamps” means the Supplemental Nutrition Assistance Program as defined and governed by ORS 411.806 through 411.845.

(9) “Grow site” means a specific location registered by the Authority used by the grower to produce marijuana for medical use by a specific patient.

(10) “Grow site registration card” means the card issued to the patient and displayed at the grow site.

(11) “Grower” has the same meaning as “person responsible for a marijuana grow site.”

(12) “Immature plant” has the same meaning as “seedling or start.”

(13) “Marijuana” means all parts of the plant Cannabis family Moraceae, whether growing or not; the resin extracted from any part of the plant; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant or its resin. It does not include the mature stalks of the plant, fiber produced from the stalks, oil or cake made from the seeds of the plant, any other compound, manufacture, salt, derivative, mixture, or preparation of the mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of the plant which is incapable of germination.

(14) “Mature plant” means a marijuana plant that does not fall within the definition of a seedling or a start.

(15) “Medical marijuana facility” is a facility, registered by the Authority, under OAR 333-008-1050.

(16) “Medical use of marijuana” means the production, possession, delivery, or administration of marijuana, or paraphernalia used to administer marijuana, as necessary for the exclusive benefit of a person to mitigate the symptoms or effects of his or her debilitating medical condition.

(17) “Oregon Health Plan (OHP)” means the medical assistance program administered by the Authority under ORS chapter 414.

(18) “OMMP” refers to the office within the Authority that administers the provisions of the OMMA, and all policies and procedures pertaining thereto, as set forth in these rules.

(19) “Parent or legal guardian” means the custodial parent or legal guardian with responsibility for health care decisions for the person under 18 years of age.

(20) “Patient” has the same meaning as “registry identification cardholder.”

(21) “Person responsible for a marijuana grow site” means a person who has been selected by a patient to produce medical marijuana for the patient, and who has been registered by the Authority for this purpose.

(22) “Person responsible for a medical marijuana facility” has the meaning given that term in OAR 333-008-1010.

(23) “Primary responsibility” as that term is used in relation to an attending physician means that the physician:

(a) Provides primary health care to the patient; or

(b) Provides medical specialty care and treatment to the patient as recognized by the American Board of Medical Specialties; or

(c) Is a consultant who has been asked to examine and treat the patient by the patient’s primary care physician licensed under ORS chapter 677, the patient’s physician assistant licensed under ORS chapter 677, or the patient’s nurse practitioner licensed under ORS chapter 678; and,

(d) Has reviewed a patient’s medical records at the patient’s request and has conducted a thorough physical examination of the patient, has provided or planned follow-up care, and has documented these activities in the patient’s medical record.

(24) “Production” includes the manufacture, planting, cultivation, growing or harvesting of a controlled substance.

(25) “Registry identification card” means a document issued by the Authority that identifies a person authorized to engage in the medical use of marijuana, and the person’s designated primary caregiver, if any.

(26) “Registry identification cardholder” means a person who has been diagnosed by an attending physician with a debilitating medical condition and for whom the use of medical marijuana may mitigate the symptoms or effects of the person’s debilitating medical condition, and who has been issued a registry identification card by the Authority.

(27) “Replacement registry identification card” means a new card issued in the event that a registry identification cardholder’s card, designated primary caregiver identification card, grower identification card, or grow site registration card is lost or stolen, or if a registry identification cardholder’s designation of primary caregiver, grower, or grow site has changed.

(28) “Seedling or start” means a marijuana plant that has no flowers, is less than 12 inches in height, and less than 12 inches in diameter. A seedling or start that does not meet all three criteria shall be considered a mature plant.

(29) “Supplemental Security Income (SSI)” means the monthly benefit assistance program administered by the federal government for persons who are age 65 or older, or blind, or disabled and who have limited income and financial resources.

(30) “Usable marijuana” means the dried leaves and flowers of the plant Cannabis family Moraceae and any mixture or preparation thereof, that are appropriate for medical use. “Usable marijuana” does not include the seeds, stalks and roots of the plant.

(31) “Written documentation” means a statement signed and dated by the attending physician of a person diagnosed with a debilitating medical condition or copies of the person’s relevant medical records, maintained in accordance with standard medical record practices.

Stat. Auth.: ORS 475.338

Stats. Implemented: ORS 475.300 - 475.346

Hist.: OHD 15-1998(Temp), f. & cert. ef. 12-24-98 thru 6-22-99; OHD 3-1999, f. & cert. ef. 4-29-99; OHD 13-2000(Temp), f. & cert. ef. 12-21-00 thru 6-15-01; OHD 18-2001, f. & cert. ef. 8-9-01; OHD 19-2001(Temp), f. & cert. ef. 8-10-01 thru 1-31-02; Administrative correction 3-14-02; OHD 6-2002, f. & cert. ef. 3-25-02; PH 9-2003, f. 6-26-03, cert. ef. 7-1-03; PH 18-2005, f. 12-30-05, cert. ef. 1-1-06; PH 15-2007, f. 12-19-07, cert. ef. 1-1-08; PH 21-2010, f. & cert. ef. 9-13-10; PH 5-2011(Temp), f. & cert. ef. 7-1-11 thru 12-27-11; PH 8-2011, f. 9-30-11, cert. ef. 10-1-11; PH 1-2014, f. & cert. ef. 1-13-14; PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14

333-008-0020

New Registration Application and Verification

(1) A person may apply for a registry identification card on forms prescribed by the Authority. In order for an application to be considered complete, an applicant must submit the following:

(a) An application form signed and dated by the applicant;

(b) Copies of legible and valid U.S. state or federal issued photographic identification that includes last name, first name, and date of birth from the applicant, the designated primary caregiver, and grower, as applicable. Acceptable forms of current U.S. state or federal issued photographic identification include but are not limited to:

(A) Driver’s license;

(B) State identification card;

(C) Passport; or

(D) Military identification card.

(c) Written documentation, which may consist of relevant portions of the applicant’s medical record, signed by the applicant’s attending physician within 90 days of the date of receipt by the Authority, which describes the applicant’s debilitating medical condition and states that the use of marijuana may mitigate the symptoms or effects of the applicant’s debilitating medical condition;

(d) If applicable, a completed and notarized “Declaration of Person Responsible for Minor” form for any person under 18 years of age, signed and dated by the person responsible for the minor;

(e) The name of a designated primary caregiver, if any;

(f) The name of a designated grower (either the patient or another person), if any and the location of the grow site; and

(g) An application fee and grow site registration fee, if applicable, in the form of cash, bank check, money order, or personal check.

(2) The Authority shall process an application prior to issuing registry identification cards to assure that the application is complete and information provided has been verified.

(a) The Authority shall only accept applications that are mailed or are hand-delivered.

(b) If an applicant does not provide all the information required and the application is considered incomplete, the Authority shall notify the applicant of the information that is missing, and shall allow the applicant 14 days to submit the missing information.

(c) If an applicant does not provide the information necessary to declare an application complete, or to complete the verification process within the timelines established in subsections (2)(b) and (3)(e) of this rule, the application shall be rejected as incomplete. An applicant whose application is rejected as incomplete may reapply at any time. If an applicant submits an application fee and the application is subsequently denied or rejected, the application fee may be applied toward a new application submitted within one year of the denial or rejection date.

(d) The Authority may reject an application if the application or supporting documents appear to be altered (for example, writing is whited out). An application shall be denied in accordance with OAR 333-008-0030 if an application or supporting documents are determined to have been falsified.

(e) The Authority may verify information on each application and accompanying documentation, including:

(A) Contacting each applicant by telephone or by mail. If proof of identity is uncertain, the Authority may require a face-to-face meeting and may require the production of additional identification materials;

(B) Contacting a minor’s parent or legal guardian;

(C) Contacting the Oregon Medical Board to verify that an attending physician is licensed to practice in the state and is in good standing;

(D) Contacting the attending physician to request further documentation to support a finding that the physician is the applicant’s attending physician. The Authority shall notify the applicant of the intent to review the medical records and request the applicant’s authorization to conduct the review. Failure to authorize a review of medical records may result in the application being declared incomplete, or denial of an application. If the Authority is unable to verify that the applicant’s attending physician meets the definition under OAR 333-008-0010(3) the applicant will be allowed 30 days to submit written documentation or a new attending physician’s declaration from a physician meeting the requirements of these rules. Failure to submit the required attending physician documentation is grounds for denial under ORS 475.309 and OAR 333-008-0030;

(E) Contacting the Division of Medical Assistance Programs, Department of Human Services-Self Sufficiency, or the Social Security Administration (SSA) to verify eligibility for benefits; and

(F) Conducting a criminal records check under ORS 181.534 of any person whose name is submitted as a grower.

(3) Application fees.

(a) A non-refundable application fee of $200 is required at the time of application.

(b) If applicable as specified in OAR 333-008-0025, a non-refundable grow site registration fee of $50 is required at the time of application.

(c) An applicant who can demonstrate current receipt of SSI benefits, current eligibility for OHP benefits or current receipt of food stamp benefits through the Oregon SNAP program qualifies for a reduced non-refundable application fee.

(A) An applicant demonstrating receipt of SSI benefits by providing a copy of a current monthly SSI benefit card showing dates of coverage is entitled to a reduced application fee of $20.

(B) An applicant demonstrating current eligibility for OHP benefits by providing a copy of the applicant’s current eligibility statement is entitled to a reduced application fee of $50.

(C) An applicant demonstrating receipt of current food stamp benefits, verified by enrollment in Oregon’s Food Stamp Management Information System database system and by providing current proof of his or her food stamp benefits, is entitled to a reduced application fee of $60.

(d) The Authority shall place a 10-day hold on the issuance of a registry identification card for an application accompanied by a personal check. Upon receipt by the Authority of a notice of non-sufficient funds (NSF) or stop payment, an applicant will be allowed 14 days to submit payment in the form of a bank check or cash. Application fees paid in the form of cash must be hand-delivered. Applicants are advised not to make payments in cash through the United States mail or private delivery services. The Authority will not accept responsibility for payments of cash that are lost in the mail or stolen in transit.

(e) The Authority shall notify an applicant who submits a reduced application fee for which the applicant is not eligible and will allow the applicant 14 days from the date of notice to pay the correct application fee and submit a current valid proof of eligibility.

(f) The application fees established in paragraphs (3)(c)(B) and (C) of this rule are effective for applications received on or after October 1, 2013.

(4) The application forms referenced in this rule may be obtained by contacting the Oregon Medical Marijuana Program (OMMP) at PO Box 14450, Portland, OR 97293-0450 or by calling 971-673-1234.

Stat. Auth.: ORS 475.338

Stats. Implemented: ORS 475.300 - 475.346

Hist.: OHD 3-1999, f. & cert. ef. 4-29-99; OHD 13-2000(Temp), f. & cert. ef. 12-21-00 thru 6-15-01; OHD 18-2001, f. & cert. ef. 8-9-01; OHD 19-2001(Temp), f. & cert. ef. 8-10-01 thru 1-31-02; Administrative correction 3-14-02; OHD 6-2002, f. & cert. ef. 3-25-02; PH 9-2003, f. 6-26-03, cert. ef. 7-1-03; PH 38-2004, f. 12-22-04, cert. ef. 1-1-05; PH 17-2005, f. 11-25-05, cert. ef. 12-1-05; PH 18-2005, f. 12-30-05, cert. ef. 1-1-06; PH 15-2007, f. 12-19-07, cert. ef. 1-1-08; PH 14-2010(Temp), f. & cert. ef. 7-6-10 thru 12-31-10; PH 27-2010, f. & cert. ef. 12-28-10; PH 8-2011, f. 9-30-11, cert. ef. 10-1-11; PH 9-2013(Temp), f. & cert. ef. 10-2-13 thru 3-30-14; PH 1-2014, f. & cert. ef. 1-13-14; PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14

333-008-0025

Marijuana Grow Site Registration

(1) A patient may register a marijuana grow site with the Authority. The address of a medical marijuana facility may not be listed by a patient on the grow site application as the location of the marijuana grow site. The Authority will register only one grow site per patient, and will only register grow sites in Oregon.

(2) To register a marijuana grow site, an applicant or patient must submit to the Authority an application, prescribed by the Authority, that includes:

(a) The name of the grower;

(b) The date of birth of the grower;

(c) The physical address of the marijuana grow site where marijuana is to be produced;

(d) The mailing address of the grower;

(e) The registry identification card number of the patient, if known, for whom the marijuana is being produced; and

(f) A non-refundable grow site registration fee of $50 in the form of cash, bank check, money order, or personal check. If the grower is the applicant, he or she is not required to pay the grow site registration fee. The Authority shall place a 10-day hold on the issuance of a registry identification card for an application accompanied by a personal check. Upon receipt by the Authority of a notice of non-sufficient funds (NSF) or stop payment, an applicant will be allowed 14 days to submit payment in the form of a bank check or cash. Application fees paid in the form of cash must be hand-delivered. Applicants are advised not to make payments in cash through the United States mail or private delivery services. The Authority will not accept responsibility for payments of cash that are lost in the mail or stolen in transit.

(3) The Authority shall conduct a criminal background check on the grower as authorized under ORS 475.304.

(a) A person convicted of a Class A or Class B felony under ORS 475.752 to 475.920 for the manufacture or delivery of a controlled substance in Schedule I or Schedule II, if the offense occurred on or after January 1, 2006, may not be issued a marijuana grow site registration card or produce marijuana for a registry identification cardholder for five years from the date of conviction.

(b) A person convicted more than once of a Class A or Class B felony under ORS 475.752 to 475.920 for the manufacture or delivery of a controlled substance in Schedule I or Schedule II, if the offenses occurred after January 1, 2006, may not be issued a marijuana grow site registration card or produce marijuana for a registry identification cardholder.

(c) The Authority shall notify a patient by certified mail that the grower is ineligible and the patient will be allowed the opportunity to identify another grower.

(4) The Authority shall issue a marijuana grow site registration card to a patient who has met the requirements of section (2) of this rule, unless the grower is disqualified under section (3) of this rule.

(5) A grower must display a marijuana grow site registration card for each patient for whom marijuana is being produced, at the marijuana grow site at all times.

(6) All usable marijuana, plants, seedlings and seeds, associated with the production of marijuana for a patient by a grower, are the property of the patient and must be provided to the patient, or, if the marijuana is usable marijuana or an immature marijuana plant, transferred to a registered medical marijuana facility, upon request.

(7) All marijuana produced for a patient must be provided to the patient or designated primary caregiver when the grower ceases producing marijuana for the patient.

(8) A grower must return the grow site registration card to the patient to whom the card was issued when requested to do so by the patient or when the grower ceases producing marijuana for the patient.

(9) A patient or the designated primary caregiver of the patient may reimburse the grower for the costs of supplies and utilities associated with production of marijuana for patient. No other costs associated with the production of marijuana for the patient, including the cost of labor, may be reimbursed.

(10) A grower may produce marijuana for no more than four patients or designated primary caregivers concurrently.

(11) The Authority may not register a grow site if the location of the grow site is the same location as a medical marijuana facility.

Stat.Auth.: ORS 475.338

Stats. Implemented: ORS 475.300 - 475.346

Hist.: PH 18-2005, f. 12-30-05, cert. ef. 1-1-06; PH 15-2007, f. 12-19-07, cert. ef. 1-1-08; PH 8-2011, f. 9-30-11, cert. ef. 10-1-11; PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14

333-008-0045

Interim Changes

(1) A patient shall notify the Authority within 30 calendar days of any change in the patient’s name, address, telephone number, attending physician, designated primary caregiver, grower or grow site address.

(2) A patient shall notify, as applicable, the designated primary caregiver, the grower, and the person responsible for a medical marijuana facility of any changes in status including, but not limited to:

(a) The assignment of another individual as the designated primary caregiver for the patient;

(b) The assignment of another individual as a grower for the patient;

(c) The revocation of an Authorization to Transfer form under OAR 333-008-1230; or

(d) The end of eligibility of the patient to hold a registry identification card.

(3) If the Authority is notified by the patient that a designated primary caregiver or a grower has changed, the Authority shall notify the designated primary caregiver or the grower by mail at the address of record confirming the change in status and informing the caregiver or grower that their card is no longer valid and must be returned to the Authority within seven calendar days.

(4) A patient who has been diagnosed by an attending physician as no longer having a debilitating medical condition or whose attending physician has determined that the medical use of marijuana is contraindicated for the patient’s debilitating medical condition shall return the registry identification card and all associated OMMP cards to the Authority within 30 calendar days of notification of the diagnosis or notification of the contraindication. If, due to circumstances beyond control of the patient he or she is unable to obtain a second medical opinion about the patient’s continuing eligibility to use medical marijuana before the 30-day period has expired, the Authority may grant the patient additional time to obtain a second opinion before requiring the patient to return the registry identification card and all associated cards.

(5) Change forms may only be submitted to the Authority via mail or in person at the OMMP office.

(6) If a patient’s designated primary caregiver, grower or grow site has changed, the non-refundable fee to receive a replacement card is $100. If the patient qualifies for the reduced application fee of $20, the non-refundable fee to receive a replacement card is $20.

(7) If a patient is registering a new grow site at any time other than when submitting a new application or a renewal application, a grow site registration fee will not be charged.

Stat. Auth.: ORS 475.309 & 475.312

Stats. Implemented: ORS 475.309 & 475.312

Hist.: PH 27-2010, f. & cert. ef. 12-28-10; PH 8-2011, f. 9-30-11, cert. ef. 10-1-11; PH 1-2014, f. & cert. ef. 1-13-14; PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14

333-008-0050

Confidentiality

(1) The Authority shall create and maintain either paper or computer data files of patients, designated primary caregivers, growers, and grow site addresses. The data files shall include all information collected on the application forms or equivalent information from other written documentation, plus a copy of OMMP registry identification cards, effective date, date of issue, and expiration date. Except as provided in section (2) of this rule, the names and identifying information of registry identification cardholders and the name and identifying information of a pending applicant for a card, a designated primary caregiver, a grower, and a marijuana grow site location, shall be confidential and not subject to public disclosure.

(2) Names and other identifying information made confidential under section (1) of this rule may be released to:

(a) Authorized employees of the Authority as necessary to perform official duties of the Authority, including the production of any reports of aggregate (i.e., non-identifying) data or statistics;

(b) Authorized employees of state or local law enforcement agencies when they provide a specific name or address. Information will be supplied only as necessary to verify:

(A) That a person is or was a lawful possessor of a registry identification card;

(B) That a person is or was a person responsible for a registered medical marijuana facility;

(C) That the address is or was a documented grow site, and how many people are authorized to grow at that grow site;

(D) How many people a person was or is authorized to grow for; or

(E) That an address is or was the location of a registered medical marijuana facility.

(c) Other persons (such as, but not limited to, employers, lawyers, family members) upon receipt of a properly executed release of information signed by the patient, the patient’s parent or legal guardian, designated primary caregiver or grower. The release of information must specify what information the Authority is authorized to release and to whom.

Stat. Auth.: ORS 475.338

Stats. Implemented: ORS 475.300 - 475.346

Hist.: OHD 3-1999, f. & cert. ef. 4-29-99; OHD 18-2001, f. & cert. ef. 8-9-01; OHD 19-2001(Temp), f. & cert. ef. 8-10-01 thru 1-31-02; Administrative correction 3-14-02; OHD 6-2002, f. & cert. ef. 3-25-02; PH 18-2005, f. 12-30-05, cert. ef. 1-1-06; PH 15-2007, f. 12-19-07, cert. ef. 1-1-08; PH 21-2010, f. & cert. ef. 9-13-10; PH 8-2011, f. 9-30-11, cert. ef. 10-1-11; PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14

333-008-0120

System to Allow Verification of Data at All Times

(1) The Authority shall establish an interactive method to allow authorized employees of state and local law enforcement agencies to use the Oregon State Police Law Enforcement Data System (LEDS) to query an OMMP data file in order to verify at any time whether a particular patient, designated primary caregiver, grower, person responsible for a medical marijuana facility, grow site location, or medical marijuana facility is listed or registered with the Authority.

(2) LEDS access will only allow a yes or no answer to the query and the information obtained may not be used for any other purpose other than verification.

(3) The Authority may allow the release of reports related to verification if it is without identifying data.

(4) The Authority shall have staff available by phone to verify law enforcement agency employee questions during regular business hours in case the electronic verification system is down, and in the event the system is expected to be down for more than two business days, the Authority shall ensure program staff are available by phone for verification purposes.

Stat. Auth.: ORS 475.338

Stats. Implemented: ORS 475.300 – 475.346

Hist.: PH 18-2005, f. 12-30-05, cert. ef. 1-1-06; PH 15-2007, f. 12-19-07, cert. ef. 1-1-08; PH 8-2011, f. 9-30-11, cert. ef. 10-1-11; PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14

333-008-1000

Applicability

(1) A person may not establish, conduct, maintain, manage or operate a facility on or after March 1, 2014, unless the facility has been registered by the Authority under these rules.

(2) Nothing in these rules exempts a PRF, an employee of a registered facility, or a registered facility from complying with any other applicable state or local laws.

(3) Registration of a facility does not protect a PRF or employees from possible criminal prosecution under federal law.

Stat. Auth.: ORS 475.314 & 475.338

Stats. Implemented: ORS 475.314

Hist.: PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14

333-008-1010

Definitions

For the purposes of OAR 333-008-1000 through 333-008-1290 the following definitions apply:

(1) “Agricultural land” means land that is located within an exclusive farm use zone as that term is described in ORS 215.203.

(2) “Attended primarily by minors” means that a majority of the students are minors.

(3) “Authority” means the Oregon Health Authority.

(4) “Batch” means a quantity of usable marijuana or a number of immature plants transferred at one time to a facility by a person authorized by a patient to transfer usable marijuana to a registered facility.

(5) “Career school” means any private proprietary professional, technical, business or other school instruction, organization or person that offers any instruction or training for the purpose or purported purpose of instructing, training or preparing persons for any profession at a physical location attended primarily by minors.

(6) “Conviction” means an adjudication of guilt upon a verdict or finding entered in a criminal proceeding in a court of competent jurisdiction.

(7)(a) “Designated primary caregiver” means an individual 18 years of age or older who has significant responsibility for managing the well-being of a person who has been diagnosed with a debilitating medical condition and who is designated as such on that person’s application for a registry identification card or in other written notification to the Authority.

(b)”Designated primary caregiver” does not include the person’s attending physician.

(8) “Domicile” means the place of abode of an individual where the person intends to remain and to which, if absent, the individual intends to return.

(9) “Edible” means a product made with marijuana that is intended for ingestion.

(10)(a) “Employee” means any person, including aliens, employed for remuneration or under any contract of hire, written or oral, express or implied, by an employer.

(b) “Employee” does not include a person who volunteers or donates services performed for no remuneration or without expectation or contemplation of remuneration as the adequate consideration for the services performed for a religious or charitable institution or a governmental entity.

(11) “Facility” means a medical marijuana facility.

(12) “Farm use” has the meaning given that term in ORS 215.203.

(13) “Finished product” means a product infused with usable marijuana that is intended for use, ingestion or consumption other than by smoking, including but not limited to edible products, ointments, and tinctures.

(14) “Grower” has the same meaning as “person responsible for a marijuana grow site.”

(15) “Grow site” means a specific location registered by the Authority and used by the grower to produce marijuana for medical use by a specific patient.

(16)(a) “Immature marijuana plant or immature plant” means a marijuana plant that has no flowers, is less than 12 inches in height, and less than 12 inches in diameter.

(b) A seedling or start that does not meet all three criteria in subsection (16)(a) is a mature plant.

(17) “Macroscopic screening” means visual observation without the aid of magnifying lens(es).

(18) “Microscopic screening” means visual observation with a minimum magnification of 40x.

(19) “Minor” means an individual under the age of 18.

(20) “Oregon Medical Marijuana Program or OMMP” means the program operated and administered by the Authority that registers patients, designated primary caregivers, and growers.

(21) “Patient” has the same meaning as “registry identification cardholder.”

(22) “Person” means an individual.

(23) “Person responsible for a marijuana grow site” means a person who has been selected by a patient to produce medical marijuana for the patient, and who has been registered by the Authority for this purpose and has the same meaning as “grower”.

(24) “Person responsible for a medical marijuana facility or PRF” means an individual who owns, operates, or otherwise has legal responsibility for a facility and who meets the qualifications established in these rules and has been approved by the Authority.

(25) “Pesticide” means any substance or mixture of substances, intended to prevent, destroy, repel, or mitigate any pest.

(26) “Premises” means a location registered by the Authority under these rules and includes all areas at the location that are used in the business operated at the location, including offices, kitchens, rest rooms and storerooms, including all public and private areas where individuals are permitted to be present.

(27) “Primary school” means a learning institution containing any combination of grades Kindergarten through 8 or age level equivalent.

(28) “Random sample” means an amount of usable marijuana taken from a batch in which different fractions of the usable marijuana have an equal probability of being represented.

(29) “Registry identification cardholder” means a person who has been diagnosed by an attending physician with a debilitating medical condition and for whom the use of medical marijuana may mitigate the symptoms or effects of the person’s debilitating medical condition, and who has been issued a registry identification card by the Authority.

(30) “Remuneration” means compensation resulting from the employer-employee relationship, including wages, salaries, incentive pay, sick pay, compensatory pay, bonuses, commissions, stand-by pay, and tips.

(31) “Resident” means an individual who has a domicile within this state.

(32) “Safe” means a metal receptacle with a locking mechanism capable of storing all usable marijuana at a registered facility that is rendered immobile by being securely anchored to a permanent structure of the building, or a “vault”.

(33) “Secondary school” means a learning institution containing any combination of grades 9 through 12 or age level equivalent and includes those institutions that provide junior high schools which include 9th grade.

(34) “These rules” means OAR 333-008-1000 through 333-008-1290.

(35) “Usable marijuana” has the meaning given that term is ORS 475.302 and includes “finished product”.

(36) “Valid testing methodology” means a scientifically valid testing methodology described in a published national or international reference and validated by the testing laboratory.

(37) “Vault” means an enclosed area that is constructed of steel-reinforced or block concrete and has a door that contains a multiple-position combination lock or the equivalent, a relocking device or equivalent, and a steel plate with a thickness of at least one-half inch.

Stat. Auth.: ORS 475.314 & 475.338

Stats. Implemented: ORS 475.314

Hist.: PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14

333-008-1020

Application for Medical Marijuana Facility Registration

(1) Beginning on March 3, 2014, at 8:30 a.m. Pacific Standard Time (PST), the Authority shall begin accepting applications for the registration of a facility. An application may be submitted at any time on or after March 3, 2014, at 8:30 a.m., PST.

(2) A PRF wishing to apply to register a facility must provide to the Authority:

(a) An application on a form prescribed by the Authority;

(b) Any additional documentation required by the Authority in accordance with these rules;

(c) The applicable fee as specified in OAR 333-008-1030; and

(d) Information and fingerprints required for a criminal background check in accordance with OAR 333-008-1130.

(3) An application for the registration of a facility must be submitted by a PRF electronically via the Authority’s website, http://mmj.oregon.gov. The documentation required in subsection (2)(b) of this rule and the information and fingerprints described in subsection (2)(d) of this rule may be submitted electronically to the Authority or may be mailed but must be postmarked within five calendar days of the date the application was submitted electronically to the Authority or the application will be considered to be incomplete. Applicable fees must be paid online at the time of application.

(4) The Authority must review each application received to ensure the application is complete, that the required documentation has been submitted, and the fee paid. The Authority shall return an incomplete application to the person that submitted the application. A person may re-submit an application that was returned as incomplete at any time.

(5) Applications will be reviewed in the order they are received by the Authority. An application that is returned as incomplete must be treated by the Authority as if it was never received.

(6) A PRF who wishes to register more than one location must submit a separate application and application fee for each location.

(7) At the time of application the PRF will be asked, by the Authority, to sign an authorization permitting the Authority to publish the location of the facility if the facility is registered.

Stat. Auth.: ORS 475.314 & 475.338

Stats. Implemented: ORS 475.314

Hist.: PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14

333-008-1030

Fees

(1) The initial fees for the registration of a facility are:

(a) A non-refundable application fee of $500; and

(b) A $3,500 registration fee.

(2) The annual renewal fees for the registration of a facility are:

(a) A $500 non-refundable renewal fee; and

(b) A $3,500 registration fee.

(3) The Authority must return the registration fee if:

(a) An application is returned to the applicant as incomplete;

(b) The Authority denies an application; or

(c) An applicant withdraws an application.

Stat. Auth.: ORS 475.314 & 475.338

Stats. Implemented: ORS 475.314

Hist.: PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14

333-008-1040

Application Review

(1) Once the Authority has determined that an application is complete it must review the application to determine compliance with ORS 475.314 and these rules.

(2) The Authority may, in its discretion, prior to acting on an application:

(a) Contact the applicant and request additional documentation or information; and

(b) Inspect the premises of the proposed facility.

(3) Prior to making a decision whether to approve or deny an application the Authority must:

(a) Ensure that the criminal background check process has been completed and review the results;

(b) Contact the OMMP and obtain documentation of whether the location of the facility is the same location as a registered grow site under OAR 333-008-0025;

(c) Review available records and information to determine whether the proposed facility is located within 1,000 feet of the real property comprising a public or private elementary, secondary or career school; and

(d) Review the list of registered facilities to determine whether any registered facilities are within 1,000 feet of the proposed facility.

(4) If during the review process the Authority determines that the application or supporting documentation contains intentionally false or misleading information the Authority must return the application to the applicant as incomplete.

Stat. Auth.: ORS 475.314 & 475.338

Stats. Implemented: ORS 475.314

Hist.: PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14

333-008-1050

Approval of Application

(1) If the proposed facility appears to be in compliance with ORS 475.314 and these rules, and the PRF has passed the criminal background check and is determined to reside in Oregon, the Authority must notify the applicant in writing that the application has been approved, that the facility is registered, and provide the applicant with proof of registration that includes a unique registration number.

(2) A facility that has been registered must display proof of registration in a prominent place inside the facility so that proof of registration is easily visible to individuals authorized to transfer usable marijuana and immature plants to the facility and individuals who are authorized to receive a transfer of usable marijuana and immature plants from the facility at all times when usable marijuana or immature plants are being transferred.

(3) A registered facility may not post any signs at the facility that use the Authority or the OMMP name or logo except to the extent that information is contained on the proof of registration.

(4) A facility’s registration is only valid for the location indicated on the proof of registration and is only issued to the PRF that is listed on the application or subsequently approved by the Authority.

(5) A facility’s registration may not be transferred to another location.

(6) If a proposed facility appears to be in compliance with ORS 475.314 and these rules except that the proposed facility does not yet have a security system installed and other security requirements in place, the Authority may issue a provisional registration that is valid for 60 days.

(a) In order to receive provisional registration a PRF must submit to the Authority at the time of application a floor plan of the facility that has marked and labeled all points of entry to the facility, all secure areas required by these rules and the proposed placement of all video cameras.

(b) The provisionally registered facility may not receive transfers of usable marijuana or immature plants or transfer usable marijuana or immature plants until the security system and other security requirements are in place and the Authority has approved the provisionally registered facility to begin operating.

(c) When the security system and other security requirements are in place the PRF must notify the Authority and if the Authority determines that the provisionally registered facility is in full compliance with these rules, the Authority must approve the facility for operation.

Stat. Auth.: ORS 475.314 & 475.338

Stats. Implemented: ORS 475.314

Hist.: PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14

333-008-1060

Denial of Application

(1) The Authority must deny an application if:

(a) An applicant fails to provide sufficient documentation that the proposed facility meets the qualifications for a facility in these rules; or

(b) The PRF has been:

(A) Convicted for the manufacture or delivery of a controlled substance in Schedule I or Schedule II within five years from the date the application was received by the Authority; or

(B) Convicted more than once for the manufacture or delivery of a controlled substance in Schedule I or Schedule II; or

(C) Prohibited by a court from participating in the OMMP.

(2) If the Authority intends to deny an application for registration it must issue a Notice of Proposed Denial in accordance with ORS 183.411 through 183.470.

Stat. Auth.: ORS 475.314 & 475.338

Stats. Implemented: ORS 475.314

Hist.: PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14

333-008-1070

Expiration and Renewal of Registration

(1) A facility’s registration expires one year following the date of application approval.

(2) If a PRF wishes to renew the facility’s registration, the person must submit to the Authority within 60 days of the registration’s expiration:

(a) An application renewal form prescribed by the Authority;

(b) The required renewal fees;

(c) Forms required for the Authority to do a criminal background check on the PRF.

Stat. Auth.: ORS 475.314 & 475.338

Stats. Implemented: ORS 475.314

Hist.: PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14

333-008-1080

Notification of Changes

(1) A PRF must notify the Authority within 10 calendar days of any of the following:

(a) The person’s conviction for the manufacture or delivery of a controlled substance in Schedule I or Schedule II;

(b) The issuance of a court order that prohibits the person from participating in the OMMP;

(c) A decision to change the PRF;

(d) A decision to permanently close the facility at that location;

(e) A decision to move to a new location;

(f) A change in the person’s residency; and

(g) The location of an elementary, secondary or career school attended primarily by minors within 1,000 feet of the facility.

(2) The notification required in section (1) of this rule must include a description of what has changed and any documentation necessary for the Authority to determine whether the facility is still in compliance with ORS 474.314 and these rules including but not limited to, as applicable:

(a) A copy of the criminal judgment or order;

(b) A copy of the court order prohibiting the PRF from participating in the OMMP;

(c) The location of the school that has been identified as being within 1,000 feet of the facility; or

(d) The information required in OAR 333-008-1120 and 333-008-1130 to determine the residency of the new PRF and to perform the criminal background check.

(3) Failure of the PRF to notify the Authority in accordance with this rule may result in revocation of a facility’s registration.

Stat. Auth.: ORS 475.314 & 475.338

Stats. Implemented: ORS 475.314

Hist.: PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14

333-008-1090

Required Closures

A facility may not receive transfers of usable marijuana or immature plants or transfer usable marijuana or immature plants if:

(1) The PRF is convicted for the manufacture or delivery of a controlled substance in Schedule I or Schedule II;

(2) The PRF changes and the Authority has not:

(a) Performed a criminal background check on the proposed PRF in accordance with OAR 333-008-1130;

(b) Determined whether the individual is a resident of Oregon; and

(c) Provided written approval that the new PRF meets the requirements of ORS 475.314.

(3) The PRF has been ordered by the court not to participate in the OMMP; or

(4) An elementary, secondary or career school attended primarily by minors is found to be within 1,000 of the registered facility.

Stat. Auth.: ORS 475.314 & 475.338

Stats. Implemented: ORS 475.314

Hist.: PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14

333-008-1100

Business Qualifications for Medical Marijuana Facility Registration

(1) A facility must be registered as a business or at the time of applying to register a facility have filed a pending application to register as a business with the Office of the Secretary of State.

(2) The Authority may not approve an application until it has verified that the facility is registered as a business with the Office of the Secretary of State.

Stat. Auth.: ORS 475.314 & 475.338

Stats. Implemented: ORS 475.314

Hist.: PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14

333-008-1110

Locations of Medical Marijuana Facilities

(1) In order to be registered a facility must be located in an area that is zoned by the local governing agency for commercial, industrial or mixed use or as agricultural land.

(2) Registration by the Authority is not a guarantee that a facility is permitted to operate under applicable land use or other local government laws where the facility is located.

(3) A facility may not be located:

(a) At the same address as a registered marijuana grow site;

(b) Within 1,000 feet of the real property comprising a public or private elementary, secondary or career school attended primarily by minors; or

(c) Within 1,000 feet of another medical marijuana facility;

(4) In order for the Authority to ensure compliance with this rule a PRF must submit with an initial application documentation that shows the current zoning for the location of the proposed facility.

(5) For purposes of determining the distance between a facility and a school referenced in subsection (3)(b) of this rule, “within 1,000 feet” means a straight line measurement in a radius extending for 1,000 feet or less in every direction from any point on the boundary line of the real property comprising an existing public or private elementary, secondary or career school primarily attended by minors.

(6) For purposes of determining the distance between a facility and another registered facility “within 1,000 feet” means a straight line measurement in a radius extending for 1,000 feet or less in every direction from any point on the boundary line of the real property compromising a registered facility.

(7) In order to be registered a facility must operate at a particular location as specified in the application and may not be mobile.

Stat. Auth.: ORS 475.314 & 475.338

Stats. Implemented: ORS 475.314

Hist.: PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14

333-008-1120

Person Responsible for a Medical Marijuana Facility (PRF)

(1) A PRF must:

(a) Be a resident of Oregon. Residency may be proved by submitting to the Authority:

(A) An Oregon driver’s license, an Oregon identification card that includes a photograph of the person, or a military identification card that includes a photograph of the person; and

(B) Copies of utility bills, rental receipts, mortgage statements or similar documents that contain the name and address of the domicile of the PRF.

(b) Have legal authority to act on behalf of the facility; and

(c) Be responsible for ensuring the facility complies with applicable laws, if registered.

(2) A PRF may not:

(a) Have been convicted in any state for the manufacture or delivery of a controlled substance in Schedule I or Schedule II within five years from the date of application; or

(b) Have been convicted more than once in any state for the manufacture or delivery of a controlled substance in Schedule I or Schedule II.

(3) At the time of application a PRF must submit to the Authority a copy of the information described in paragraphs (1)(a)(A) and (B) of this rule.

(4) A PRF is accountable for any intentional or unintentional action of its owners, officers, managers, employees or agents, with or without the knowledge of the PRF, who violate ORS 475.314 or these rules.

(5) If a PRF no longer meets the criteria of a PRF the Authority shall inform the PRF and the owner of the facility if different that:

(a) The PRF may no longer serve in that capacity;

(b) In order to remain certified, a change of PRF form must be submitted; and

(c) The facility may not operate until the Authority has approved a new PRF.

(6) If the Authority is notified that a change of PRF is needed, the current PRF is no longer able to serve as the PRF, or the PRF has been or will be removed by the owner of a facility, the owner of the facility must submit a change of PRF form to Authority within 10 business days of the notification or the Authority will begin proceedings to revoke the certification of the facility.

(7) If the PRF of record for the facility is no longer serving in that capacity the facility may not operate until a new PRF has been approved by the Authority.

Stat. Auth.: ORS 475.314 & 475.338

Stats. Implemented: ORS 475.314

Hist.: PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14

333-008-1130

Criminal Background Checks

(1) A PRF must, at the time of application, provide to the Authority:

(a) A criminal background check request form, prescribed by the Authority that includes but is not limited to:

(A) First, middle and last name;

(B) Any aliases;

(C) Date of birth;

(D) Driver’s license information; and

(E) Address and recent residency information.

(b) Fingerprints in accordance with the instructions on the Authority’s webpage: http://mmj.oregon.gov.

(2) The Authority may request that the PRF disclose his or her Social Security Number if notice is provided that:

(a) Indicates the disclosure of the Social Security Number is voluntary; and

(b) That the Authority requests the Social Security Number solely for the purpose of positively identifying the PRF during the criminal records check process.

(3) The Authority shall conduct a criminal records check in order to determine whether the PRF has been convicted of the manufacture or delivery of a controlled substance in Schedule I or Schedule II in any state.

(4) The Authority must conduct a criminal background check in accordance with this rule on a PRF every year at the time of application renewal.

(5) If a PRF wishes to challenge the accuracy or completeness of information provided by the Department of State Police, the Federal Bureau of Investigation and agencies reporting information to the Department of State Police or Federal Bureau of Investigation, those challenges must be made through the Department of State Police, Federal Bureau of Investigation or reporting agency and not through the contested case process specified in OAR 333-008-1060(2).

Stat. Auth.: ORS 475.314 & 475.338

Stats. Implemented: ORS 475.314

Hist.: PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14

333-008-1140

Security for Registered Facilities

(1) The PRF must ensure that a registered facility complies with OAR 333-008-1140 through 333-008-1180.

(2) The PRF is responsible for the security of all usable marijuana and immature plants in the registered facility, including providing adequate safeguards against theft or diversion of usable marijuana and immature plants and records that are required to be kept.

(3) The PRF must ensure that commercial grade, non-residential door locks are installed on every external door at a registered facility prior to opening for business and used while a facility is registered.

(4) During all hours when the registered facility is open for business, the PRF must ensure that:

(a) All usable marijuana and immature plants received and all usable marijuana and immature plants available for transfer to a patient or a designated primary caregiver are kept in a locked, secure area that can only be accessed by authorized personnel.

(b) All areas where usable marijuana or immature plants are received for transfer by a registered facility are identified as a restricted access area by posting a sign not less than 12 inches wide and 12 inches long, composed of letters not less than one-half inch in height that reads, “Restricted Access Area — Authorized Personnel Only”.

(c) All areas where usable marijuana or immature plants are available for transfer to a patient or designated primary caregiver are:

(A) Identified as a restricted access area and clearly identified by the posting of a sign not less than 12 inches wide and 12 inches long, composed of letters not less than one-half inch in height that reads “Restricted Access Area — No Minors Allowed”;

(B) Supervised by the PRF or an employee of the registered facility at all times when a patient or designated primary caregiver is present; and

(C) Separate from any area where usable marijuana or immature plants are being transferred to a registered facility.

(5) During all hours when the registered facility is not open for business the PRF must ensure that:

(a) All entrances to and exits from the facility are securely locked and any keys or key codes to the facility remain in the possession of the PRF or authorized employees;

(b) All usable marijuana is kept in a safe; and

(c) All immature plants are in a locked room.

(6) The PRF must ensure that:

(a) Electronic records are encrypted, and securely stored to prevent unauthorized access and to ensure confidentiality;

(b) There is an electronic back-up system for all electronic records; and

(c) All video recordings and archived required records not stored electronically are kept in a locked storage area. Current records may be kept in a locked cupboard or desk outside the locked storage area during hours when the registered facility is open.

Stat. Auth.: ORS 475.314 & 475.338

Stats. Implemented: ORS 475.314

Hist.: PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14

333-008-1150

Alarm System for Registered Facilities

(1) Prior to opening for business, a PRF must ensure that a registered facility has a security alarm system, installed by an alarm installation company, on all facility entry or exit points and perimeter windows.

(2) At the time of application a PRF must submit to the Authority documentation of the:

(a) Alarm system that is installed or proposed for installation;

(b) Company that installed the system or plans to install the system;

(c) Features of the system that meet the criteria of this rule.

(3) A PRF must ensure that the facility is continuously monitored by the alarm system.

(4) The security alarm system for the registered facility must:

(a) Be able to detect movement inside the registered facility;

(b) Be programmed to notify a security company that will notify the PRF or his or her designee in the event of a breach; and

(c) Have at least two “panic buttons” located inside the registered facility that are linked with the alarm system.

Stat. Auth.: ORS 475.314 & 475.338

Stats. Implemented: ORS 475.314

Hist.: PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14

333-008-1160

Video Surveillance Equipment for Registered Facilities

(1) Prior to opening for business, a PRF must install a fully operational video surveillance recording system.

(2) At the time of application a PRF must submit to the Authority documentation of the:

(a) Video surveillance system that is installed or proposed for installation;

(b) Company or person that installed the system or plans to install the system;

(c) Features of the system that meet the criteria of this rule.

(3) Video surveillance equipment must, at a minimum:

(a) Consist of:

(A) Digital or network video recorders;

(B) Cameras capable of meeting the requirements of OAR 333-008-1170 and this rule;

(C) Video monitors;

(D) Digital archiving devices; and

(E) A color printer capable of producing still photos.

(b) Be equipped with a failure notification system that provides prompt notification to the PRF or employees of any prolonged surveillance interruption or failure; and

(c) Have sufficient battery backup to support a minimum of one hour of recording time in the event of a power outage.

(4) All video surveillance equipment and recordings must be stored in a locked secure area that is accessible only to the PRF, authorized employees of the registered facility and the Authority.

Stat. Auth.: ORS 475.314 & 475.338

Stats. Implemented: ORS 475.314

Hist.: PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14

333-008-1170

Required Camera Coverage and Camera Placement for Registered Facilities

(1) A PRF must ensure that a registered facility has camera coverage for:

(a) All secure and restricted access areas described in OAR 333-008-1140;

(b) All point of sale areas;

(c) All points of entry to or exit from secure and restricted access areas; and

(d) All points of entry to or exit from the registered facility.

(2) A PRF must ensure that camera placement is capable of identifying activity occurring within 15 feet of all points of entry to the registered facility and exit from the registered facility and shall allow for the clear and certain identification of any individual and activities on the facility premises.

Stat. Auth.: ORS 475.314 & 475.338

Stats. Implemented: ORS 475.314

Hist.: PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14

333-008-1180

Video Recording Requirements for Registered Facilities

(1) The PRF must ensure that all camera views of all secure and restricted access areas and points of entry to or exit from the registered facility are continuously monitored by motion sensor video equipment or similar technology 24 hours a day.

(2) A PRF must ensure that:

(a) All surveillance recordings are kept for a minimum of 30 days and are in a format that can be easily accessed for viewing;

(b) The surveillance system has the capability to produce a color still photograph from any camera image;

(c) The date and time is embedded on all surveillance recordings without significantly obscuring the picture;

(d) Video recordings are archived in a format that ensures authentication of the recording as a legitimately-captured video and guarantees that no alterations of the recorded image has taken place; and

(e) Video surveillance records and recordings are available upon request to the Authority for the purpose of ensuring compliance with ORS 475.314 and these rules.

Stat. Auth.: ORS 475.314 & 475.338

Stats. Implemented: ORS 475.314

Hist.: PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14

333-008-1190

Testing

(1) A PRF must ensure that usable marijuana and immature plants are tested for pesticides, mold and mildew in accordance with this rule prior to the usable marijuana or immature plants being transferred to a patient or a designated primary caregiver.

(2) Upon usable marijuana being transferred to a registered facility in accordance with OAR 333-008-1230, the PRF must ensure the usable marijuana is segregated into batches, that each batch is placed in an individual container or bag, and that a label is attached to the container or bag that includes at least the following information:

(a) A unique identifier;

(b) The name of the person who transferred it; and

(c) The date the usable marijuana was received by the registered facility.

(3) Sampling. A PRF must ensure that random samples from each batch are taken in an amount necessary to conduct the applicable test, that the samples are labeled with the batch’s unique identifier, and submitted for testing.

(4) Testing. A PRF must ensure that each sample is tested for pesticides, mold, and mildew and for an analysis of the levels of tetrahydrocannabinol (THC) and Cannabidiol (CBD).

(a) Immature Plants. An immature plant may be tested for pesticides, mold or mildew by conducting a macroscopic or microscopic screening to determine if the plant has visible pesticide residue, mold or mildew.

(b) Flowers or other usable marijuana plant material. Usable marijuana in the form of flowers or other plant material must be:

(A) Tested for pesticides, mold and mildew using valid testing methodologies and macroscopic or microscopic screening may not be used;

(B) Tested for pesticides by testing for the following analytes:

(i) Chlorinated Hydrocarbons;

(ii) Organophosphates;

(iii) Carbamates; and

(iv) Pyrethroids; and

(C) Analyzed, using valid testing methodologies, to determine the levels of THC and CBD.

(c) Edibles, Liquids and Solid Extracts. If the usable marijuana used in the edible, liquid or solid extract has been tested in accordance with this rule and tested negative for pesticides, mold or mildew, the edible, liquid or solid extract does not need to be tested for pesticides, mold and mildew but does need to be tested for an analysis of the levels of THC and CBD. If the usable marijuana used in the edible, liquid, or solid extract was not tested in accordance with this rule, the edible, liquid or solid extract must be tested for pesticides, mold or mildew in accordance with subsection (4)(b) of this rule.

(5) Laboratory Requirements. A PRF must ensure that all testing, except for testing of immature plants, is done by a third party or in-house laboratory that:

(a) Uses valid testing methodologies; and

(b) Has a Quality System for testing of pesticides, mold and mildew that is compliant with the:

(A) 2005 International Organization for Standardization 17025 Standard; or

(B) 2009 National Environmental Laboratory Accreditation Conference Institute TNI Standards.

(6) Macroscopic or microscopic screening of immature plants must be conducted by a person who has a minimum of a bachelor’s degree in horticulture, botany, plant pathology, microbiology, or an equivalent degree but is not required to be done by a laboratory.

(7) Testing Results. A laboratory must provide testing results to the PRF signed by an official of the laboratory who can attest to the accuracy of the results, and that includes the levels of pesticides, mold or mildew detected and the levels of THC and CBD.

(a) If an immature plant has visible pesticide residue, mold or mildew it must be deemed to test positive and must be returned to the person who transferred the immature plant to the registered facility.

(b) A sample of usable marijuana shall be deemed to test positive for mold and mildew if the sample has levels that exceed the maximum acceptable counts in the Pharmacopeia, Section 1111 (May 1, 2009), incorporated by reference.

(c) A sample of usable marijuana shall be deemed to test positive for pesticides with a detection of more than 0.1 parts per million of any pesticide.

(8) If an immature plant or sample of usable marijuana tests positive for pesticides, mold or mildew based on the standards in this rule the PRF must ensure the entire batch from which the sample was taken is returned to the person who transferred the immature plant or usable marijuana to the registered facility and must document how many or how much was returned, to whom, and the date it was returned.

(9) A registered facility may perform its own testing as long as the testing complies with this rule.

(10) The PRF may permit laboratory personnel or other persons authorized to do testing access to secure or restricted access areas of the registered facility where usable marijuana or immature plants are stored. The PRF must log the date and time in and out of all such persons.

Stat. Auth.: ORS 475.314 & 475.338

Stats. Implemented: ORS 475.314

Hist.: PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14

333-008-1200

Operation of Registered Facilities

(1) A PRF must ensure that a registered facility does not permit:

(a) A minor to be present in any area of a registered facility where usable marijuana or immature plants are present, even if the minor is a patient or an employee; and

(b) Consumption, ingestion, inhalation or topical application of usable marijuana anywhere on the premises of the registered facility, except that an employee of a registered facility who is a patient may consume usable marijuana during their work shift as necessary for his or her medical condition, in a closed room, alone if the usable marijuana is being smoked, not visible to the public or to patients or caregivers on the premises of the registered facility to receive a transfer of usable marijuana or an immature plant.

(2) A PRF must ensure that a registered facility uses an Oregon Department of Agriculture approved scale to weigh all usable marijuana.

(3) The following persons are the only persons permitted in any area of a registered facility where usable marijuana or immature plants are present, and only in accordance with these rules, as applicable:

(a) A PRF;

(b) An owner of a registered facility;

(c) An employee of the registered facility;

(d) Laboratory personnel in accordance with OAR 333-008-1190;

(e) A contractor authorized by the PRF to be on the premises of a registered facility;

(f) A patient, designated primary caregiver, or growers;

(g) An authorized employee or authorized contractor of the Authority; and

(h) Other government officials that have jurisdiction over some aspect of the registered facility or that otherwise have authority to be on the premises of the registered facility.

(4) A PRF must have written detailed policies and procedures and training for employees on the policies and procedures that at a minimum, cover the following:

(a) Security;

(b) Testing;

(c) Transfers of usable marijuana and plants to and from the facility;

(d) Operation of a registered facility;

(e) Required record keeping;

(f) Labeling; and

(g) Violations and enforcement.

Stat. Auth.: ORS 475.314 & 475.338

Stats. Implemented: ORS 475.314

Hist.: PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14

333-008-1210

Record Keeping

(1) A PRF must ensure that the following information is documented and maintained electronically in a manner that can easily be shared with the Authority or accessed by the Authority:

(a) All Authorization to Transfer forms, including the date on which a form was received;

(b) Any written notifications from a patient with regard to any change in status as required by ORS 475.309(7)(a)(B) or (10)(a);

(c) Any revocation of an Authorization to Transfer form;

(d) All transfer information required in OAR 333-008-1230 and 333-008-1240;

(e) Documentation of the costs of doing normal and customary business used to establish the reimbursement amounts for transfers of usable marijuana or immature plants, including costs related to transferring, handling, securing, insuring, testing, packaging and processing usable marijuana and immature marijuana plants and the cost of supplies, utilities and rent or mortgage.

(f) The amount of money paid by a registered facility to a grower for each transfer of usable marijuana or immature plants;

(g) The amount of money paid by each patient or designated primary caregiver for a transfer of usable marijuana or an immature plant;

(h) The laboratory reports of all testing and other information required to be documented in OAR 333-008-1190; and

(i) All other information required to be documented and retained in these rules.

(2) The PRF must ensure that information required to be documented pursuant to section (1) of this rule is maintained in a safe and secure manner that protects the information from unauthorized access, theft, fire, or other destructive forces, and is easily retrievable for inspection by the Authority upon request, either at the registered facility or online.

(3) A PRF must ensure that a registered facility uses an electronic data management system for the recording of transfers of usablel marijuana and immature plants. The system must meet the following minimum requirements:

(a) Record the information required to be documented in this rule and OAR 333-008-1230 and 333-008-1240;

(b) Provide for off-site or secondary backup system;

(c) Assign a unique transaction number for each transfer to or from the registered facility;

(d) Monitor date of testing and testing results;

(e) Track products by unique transaction number through the transfer in, testing and transfer out processes;

(f) Generate transaction and other reports requested by the Authority viewable in PDF format;

(g) Produce reports, including but not limited to inventory reports; and

(h) Provide security measures to ensure patient and grower records are kept confidential.

(4) Documents and information required to be maintained in these rules must be retained by the PRF for at least one year.

(5) A PRF must provide the Authority with any documentation required to be maintained in these rules upon request, in the format requested by the Authority, or permit the Authority access to such documentation on-site.

Stat. Auth.: ORS 475.314 & 475.338

Stats. Implemented: ORS 475.314

Hist.: PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14

333-008-1220

Labeling

(1) Prior to transferring usable marijuana a PRF must ensure that a label is affixed to the usable marijuana that includes but is not limited to:

(a) The amount of THC and CBD in the usable marijuana;

(b) If pre-packaged, the weight or volume of the packaged usable marijuana in metric units;

(c) The amount of usable marijuana in a finished product in metric units;

(d) Potency information; and

(e) Who performed the testing.

(2) If the registered facility transfers usable marijuana in a form that is edible, the PRF must ensure that the usable marijuana has a warning label on the outside of the packaging that includes the following: “WARNING: MEDICINAL PRODUCT — KEEP OUT OF REACH OF CHILDREN” in bold capital letters, in a font size that is larger than the type-size of the other printing on the label such that it is easy to read and prominently displayed on the product.

Stat. Auth.: ORS 475.314 & 475.338

Stats. Implemented: ORS 475.314

Hist.: PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14

333-008-1230

Transfers to a Registered Facility

(1) A patient may authorize usable marijuana or immature marijuana plants to be transferred to a registered facility by signing an Authorization to Transfer form prescribed by the Authority. A patient may authorize transfers to more than one registered facility. A separate form must be provided for each registered facility. The Authorization must include, but is not limited to, the following information:

(a) The patient’s name, OMMP card number and expiration date and contact information;

(b) The name and contact information of the individual who is authorized to transfer the usable marijuana or immature marijuana plants to the registered facility and that individual’s OMMP card number and expiration date;

(c) The name and address of the registered facility that is authorized to receive the usable marijuana or immature marijuana plants; and

(d) The date the authorization expires, if earlier than the expiration date of the patient’s OMMP card.

(2) Only a patient, the patient’s designated primary caregiver, or the patient’s grower may be authorized to transfer usable marijuana or immature plants to a registered facility.

(3) The original Authorization to Transfer form must be provided to the registered facility to which a transfer may be made by the patient or person authorized to transfer the usable marijuana or immature plants. The patient should retain a copy of the Authorization to Transfer form for his or her records and provide a copy to the person authorized to transfer the usable marijuana or immature plants.

(4) An Authorization to Transfer form automatically expires on the date the patient’s OMMP card expires, unless the patient has specified an earlier expiration date. If the patient renews his or her OMMP card the patient may execute a new Authorization to Transfer form in accordance with this rule.

(5) Once usable marijuana or an immature plant is transferred to a registered facility pursuant to a valid Authorization to Transfer form, the usable marijuana or immature plant is no longer the property of the patient unless the usable marijuana or immature plants are returned by the registered facility.

(6) Prior to a registered facility accepting a transfer of usable marijuana or immature plants the PRF must ensure that:

(a) It has a valid Authorization to Transfer form on file that authorizes the individual that is transferring the usable marijuana or immature plants to make the transfer; and

(b) The individual transferring the usable marijuana or immature plants is the individual authorized to make the transfer.

(7) A PRF must ensure that when a registered facility accepts a transfer of usable marijuana or an immature plant the batch of usable marijuana and each immature plant are segregated in accordance with the testing rule, OAR 333-008-1190 and that the following information is documented, as applicable:

(a) The unique identifier;

(b) The weight in metric units of all usable marijuana received by the registered facility;

(c) The number of immature plants received by the registered facility;

(d) The amount of a finished product received by the registered facility, including, as applicable, the weight in metric units, or the number of units of a finished product;

(e) A description of the form the usable marijuana was in when it was received, for example, oil or an edible product;

(f) Who transferred the usable marijuana or the immature plant, the individual’s OMMP card number and expiration date of the card, a copy of the individual’s picture identification, the date the usable marijuana or an immature plant was received, and the name of the patient who authorized the transfer; and

(g) The amount of reimbursement paid by the registered facility.

(8) Nothing in these rules requires a PRF or a registered facility to accept a transfer of usable marijuana or immature plants.

(9) A PRF must ensure that:

(a) From the time that a batch or plant has been received by the registered facility until it is tested in accordance with these rules, the usable marijuana and immature plants are segregated, withheld from use, and kept in a secure location so as to prevent the marijuana or plants from becoming contaminated or losing efficacy, or from being tampered with or transferred except that samples may be removed for testing; and

(b) No usable marijuana or immature plants are transferred to a patient or designated primary caregiver until testing has been completed, the registered facility has received a written testing report, and the usable marijuana and immature plants have tested negative for pesticides, mold and mildew.

(10) Usable marijuana and immature plants must be kept on-site at the facility. The Authority may cite a PRF for a violation of these rules if during an inspection it cannot account for its inventory or if the amount of usable marijuana at the registered facility is not within five percent of the documented inventory.

Stat. Auth.: ORS 475.314 & 475.338

Stats. Implemented: ORS 475.314

Hist.: PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14

333-008-1240

Transfers to a Patient or Designated Primary Caregiver

(1) Prior to a registered facility transferring usable marijuana or an immature plant to a patient or a designated primary caregiver the PRF must ensure that:

(a) The usable marijuana or an immature plant has not tested positive for mold, mildew or pesticides as specified in OAR 333-008-1190; and

(b) The identity and cardholder status of the person requesting usable marijuana or an immature plant is verified by viewing the person’s OMMP card and picture identification and making sure the two match.

(2) The PRF must ensure that for each transfer of usable marijuana or an immature plant to a patient or a designated primary caregiver the following information is documented:

(a) The name, OMMP card number and expiration date of the card of each person to whom the registered facility transfers usable marijuana or an immature plant;

(b) A copy of the person’s picture identification;

(c) The amount of usable marijuana transferred in metric units, if applicable;

(d) The number of immature plants transferred, if applicable;

(e) The amount of a finished product transferred in metric units, or units of the finished product, if applicable;

(f) A description of what was transferred;

(g) The date of the transfer; and

(h) The amount of money paid by a patient or a designated primary caregiver to a registered facility for the transfer of usable marijuana or an immature plant.

(3) The PRF must ensure that a registered facility does not transfer at any one time more usable marijuana or immature plants than a patient or designated primary caregiver is permitted to possess under ORS 475.320(1)(a). A PRF is not responsible for determining whether a patient or designated primary caregiver is limited in the amount of usable marijuana he or she can possess under 475.320(1)(b).

Stat. Auth.: ORS 475.314 & 475.338

Stats. Implemented: ORS 475.314

Hist.: PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14

333-008-1250

Inspections

(1) The Authority must conduct an initial inspection of every registered facility within six months of approving an application to ensure compliance with these rules, and must conduct a routine inspection of every registered facility at least every year.

(2) The Authority may conduct a complaint inspection at any time following the receipt of a complaint that alleges a registered facility is in violation of ORS 475.314 or these rules.

(3) The Authority may conduct an inspection at any time if it believes, for any reason, that a registered facility or a PRF is in violation of ORS 475.314 or these rules.

(4) A PRF and any employees, contractors, or other individuals working at a registered facility must cooperate with the Authority during an inspection.

(5) If an individual at a registered facility fails to permit the Authority to conduct an inspection the Authority may seek an administrative warrant authorizing the inspection pursuant to ORS 431.262.

Stat. Auth.: ORS 431.262, 475.314 & 475.338

Stats. Implemented: ORS 431.262 & 475.314

Hist.: PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14

333-008-1260

Violations

(1) A registered facility is in violation of ORS 475.314 or these rules for:

(a) A PRF or an employee of a facility failing to cooperate with an inspection;

(b) The submission by a PRF of false or misleading information to the Authority in support of an application or in seeking to retain registration;

(c) Transferring usable marijuana or immature plants to an individual who is not a patient or a designated primary caregiver;

(d) Accepting a transfer of usable marijuana or immature plants without a valid authorization from the patient;

(e) Possessing a mature marijuana plant at the registered facility;

(f) Failing to document and maintain information in the manner required by these rules;

(g) Failing to account for usable marijuana or immature plants on the premises of the registered facility, taking into account a five percent loss;

(g) Failing to submit a plan of correction in accordance with OAR 333-008-1270;

(h) Failing to comply with a final order of the Authority, including failing to pay a civil penalty; or

(i) Failing to comply with ORS 475.314 or any of these rules.

(2) It is a violation of ORS 475.314 and these rules to operate a facility without being registered by the Authority.

Stat. Auth.: ORS 475.314 & 475.338

Stats. Implemented: ORS 475.314

Hist.: PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14

333-008-1270

Enforcement

(1)(a) Informal Enforcement. If, during an inspection the Authority documents violations of ORS 475.314 or any of these rules, the Authority may issue a written Notice of Violation to the PRF that cites the laws alleged to have been violated and the facts supporting the allegations.

(b) The PRF must submit to the Authority a signed plan of correction within 10 business days from the date the Notice of Violation was mailed to the person. A signed plan of correction will not be used by the Authority as an admission of the violations alleged in the Notice.

(c) A PRF must correct all deficiencies within 10 days from the date of the Notice, unless an extension of time is requested from the Authority. A request for such an extension shall be submitted in writing and must accompany the plan of correction.

(d) The Authority must determine if a written plan of correction is acceptable. If the plan of correction is not acceptable to the Authority it must notify the PRF in writing and request that the plan of correction be modified and resubmitted no later than 10 working days from the date the letter of non-acceptance was mailed.

(e) If the registered facility does not come into compliance by the date of correction reflected on the plan of correction, the Authority may propose to revoke the registration of the facility or impose civil penalties.

(f) The Authority may conduct an inspection at any time to determine whether a registered facility has corrected the deficiencies in a Notice of Violation.

(2) Formal Enforcement. If, during an inspection or based on other information the Authority determines that a registered facility or PRF is in violation of ORS 475.314 or these rules the Authority may issue:

(a) A Notice of Proposed Revocation in accordance with ORS 183.411 through 183.470; or

(b) A Notice of Imposition of Civil Penalties in accordance with ORS 183.745. Civil penalties may be issued for any violation of 475.314 and these rules, not to exceed $500 per violation per day.

(3) The Authority must determine whether to use the informal or formal enforcement process based on the nature of the alleged violations, whether there are mitigating or aggravating factors, and whether the PRF or the registered facility has a history of violations.

(4) The Authority must issue a Notice of Proposed Revocation if the:

(a) Facility no longer meets the criteria in ORS 475.314(3)(a) to (d); or

(b) PRF is not a resident of Oregon, has disqualifying criminal convictions as described in OAR 333-008-1120, or a court has issued an order that prohibits the PRF from participating in the OMMP under ORS 475.300 through 475.346 unless a new PRF is approved by the Authority.

(5) The Authority may maintain a civil action against a facility that is operating but not registered in accordance with ORS 475.314 and these rules.

(6) The Authority must post a final order revoking the registration of a facility on the Authority’s website and provide a copy of the final order to the OMMP.

(7) To the extent permitted by law, if the Authority discovers violations that may constitute criminal conduct or conduct that is in violation of laws within the jurisdiction of other state or local governmental entities, the Authority may refer the matter to the applicable agency.

(8) If the registration of a facility is revoked the PRF must make arrangements to return the usable marijuana and immature plants in amounts still possessed by the facility, to the person who transferred the usable marijuana or immature plants and must document the same.

Stat. Auth.: ORS 431.262, 475.314 & 475.338

Stats. Implemented: ORS 431.262 & 475.314

Hist.: PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14

333-008-1280

Confidentiality

(1) Any criminal background information received by the Authority about a PRF during the criminal background check process is confidential and is not subject to disclosure without a court order.

(2) The name of a PRF and the address of a registered facility is confidential and is not subject to disclosure without a court order, except as provided in section (5) of this rule, or unless a PRF has authorized disclosure.

(3) If an application has been denied, the information submitted to the Authority in an application for registration of a facility is not confidential and may be subject to disclosure under ORS 192.410 through 192.505.

(4) A final order revoking the registration of a facility is not confidential and may be posted on the Authority’s website or otherwise made public by the Authority.

(5) Authorized employees of state and local law enforcement agencies may verify with the Authority at all times whether:

(a) A location is the location of a registered facility; or

(b) A person is listed as the PRF of a registered facility.

Stat. Auth.: ORS 475.314 & 475.338

Stats. Implemented: ORS 475.314 & 475.331

Hist.: PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14

333-008-1290

Change of Location

(1) A registered facility that changes location must submit a new application that complies with OAR 333-008-1020.

(2) A facility may not operate at a new location unless it is registered by the Authority.

Stat. Auth.: ORS 475.314 & 475.338

Stats. Implemented: ORS 475.314

Hist.: PH 2-2014(Temp), f. 1-14-14, cert. ef. 1-15-14 thru 7-13-14

Notes
1.) This online version of the OREGON BULLETIN is provided for convenience of reference and enhanced access. The official, record copy of this publication is contained in the original Administrative Orders and Rulemaking Notices filed with the Secretary of State, Archives Division. Discrepancies, if any, are satisfied in favor of the original versions. Use the OAR Revision Cumulative Index found in the Oregon Bulletin to access a numerical list of rulemaking actions after November 15, 2013.

2.) Copyright Oregon Secretary of State: Terms and Conditions of Use

Oregon Secretary of State • 136 State Capitol • Salem, OR 97310-0722
Phone: (503) 986-1523 • Fax: (503) 986-1616 • oregon.sos@state.or.us

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