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The Oregon Administrative Rules contain OARs filed through April 15, 2013

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OREGON HEALTH AUTHORITY, OFFICE FOR OREGON HEALTH POLICY AND RESEARCH

DIVISION 23

HOSPITAL REPORTING

Health Care Acquired Infection Reporting and Public Disclosure

409-023-0000

Definitions

The following definitions apply to OAR 409-023-0000 to 409-023-0035:

(1) “Administrator” means the administrator of the Office for Oregon Health Policy and Research as defined in ORS 442.011, or the administrator’s designee.

(2) “ASC” means ambulatory surgical center as defined in ORS 442.015(3) and that is licensed pursuant to ORS 441.015.

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

(4) “CDC” mean the federal Centers for Disease Control and Prevention.

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

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

(7) “CMS” mean the federal Centers for Medicare and Medicaid Services.

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

(9) “Committee” means the Health Care Acquired Infections Advisory Committee as defined in notes following ORS 442.851 relating to Health Care Acquired Infections.

(10) “Dialysis facility” means outpatient renal dialysis facility as defined in ORS 442.015(20).

(11) “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.

(12) “HAI” means health care acquired infection as defined in notes following ORS 442.851 relating to Health Care Acquired Infections.

(13) “Health care facility” means a facility as defined in ORS 442.015(10).

(14) "Hospital" means a facility as defined in ORS 442.015(13) and that is licensed pursuant to ORS 441.015.

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

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

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

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

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

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

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

(22) “LTC facility” means long term care facility as defined in ORS 442.015(16).

(23) “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.

(24) “Medical ICU” means a non-specialty intensive care unit that serves 80% or more adult medical patients.

(25) “Medical/Surgical ICU” means a non-specialty intensive care unit that serves less than 80% of either adult medical, adult surgical, or specialty patients.

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

(27) “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.

(28) “NHSN Manual” means the Patient Safety Component Protocol of the NHSN manual, version March 2009 or its successor, as amended, revised, and updated from time to time.

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

(30) “Office” means the Office for Oregon Health Policy and Research.

(31) “Oregon HAI group” means the NHSN group administered by the Office.

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

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

(34) “Person” has the meaning as defined in ORS 442.015(21).

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

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

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

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

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

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

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

(42) “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).

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

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

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

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

(47) “Specialty ICU” mean an intensive care unit with at least 80% of adults are specialty patients including but not limited to oncology, trauma, and neurology.

(48) “SSI” means a surgical site infection event as defined in the Patient Safety Component Protocol of the NHSN manual, version January 2008.

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

(50) “State agency” shall have the meaning as defined in ORS 192.410(5).

(51) “Surgical ICU” means a non-specialty intensive care unit that serves 80% or more 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

409-023-0005

Review

Unless otherwise directed by the administrator, the committee shall review these rules (OAR 409-023-0000 to 409-023-0035) no later than July 1, 2009 and thereafter at least biennially.

Stat. Auth.: ORS 442.420(3)(d) & 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

409-023-0010

HAI Reporting for Hospitals

(1) Hospitals shall begin collecting data for HAI outcome and process measures for the HAI reporting program for services provided on and after January 1, 2009, except:

(a) NICU shall begin collecting data for HAI outcome and process measures for the HAI reporting program for services provided on and after January 1, 2010.

(b) Hospitals shall report the SCIP-Inf-6 process measure for the HAI reporting program for services provided on and after January 1, 2010.

(c) Hospitals shall report the SCIP-4-Inf and SCIP-10-Inf process measures for services provided on and after January 1, 2011.

(d) Hospitals shall report the NHSN Inpatient COLO, HPRO, HYST, and LAM outcome measures for services provided on and after January 1, 2011.

(e) Hospitals shall report facility-wide NHSN Inpatient CDI data using the Lab-ID method for CDI in NHSN for services provided on or after January 1, 2012.

(f) Hospitals shall report SCIP-Inf-9 performance measures for services provided on or after January 1, 2012.

(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.

(3) The infection control professional (ICP), as defined by the facility, shall actively seek out infections defined in sections (2)(a) and (b) 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;

(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 section (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;

(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. This includes but is 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 Office as necessary for compliance of 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 409-023-0010(1) the following HAI process measures:

(a) SCIP-Inf-1;

(b) SCIP-Inf-2;

(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. This includes but is 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 Office as necessary for compliance with these rules, including but not limited to facility identifiers.

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

(10) Each hospital shall complete an annual survey, as defined by the Office, of influenza vaccination of staff and submit the completed survey to the Office. The survey shall include but not be limited to 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.

(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 & Notes following ORS 442.851
Stats. Implemented: ORS 442.405 & Notes following ORS 442.851
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

409-023-0012

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 Office.

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

(3) Starting with the 2011-2012 influenza season, each ASC shall complete an annual survey, as defined by the Office, of influenza vaccination of staff and submit the completed survey to the Office. The survey shall include but not be limited to 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.

Stat. Auth.: ORS 442.420(3)(d) & 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

409-023-0013

HAI Reporting for Long Term Care Facilities

(1) The HAI Reporting System for outcome measures shall be MDS and reporting will be mandatory for services provided on or after January 1, 2010.

(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. This includes but is 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 Office, of influenza vaccination of staff and submit the completed survey to the Office. The survey shall include but not be limited to 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.

(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(3)(d) & 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

409-023-0015

HAI Reporting for Other Health Care Facilities

Dialysis facilities shall begin collecting data for the HAI reporting program for services provided on and after January 1, 2013 pursuant to rules amended no later than July 1, 2012.

Stat. Auth.: ORS 442.420(3)(d) & 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

409-023-0020

HAI Public Disclosure

(1) The Office shall disclose to the public updated facility-level and state-level HAI rates at least biannually beginning in January 2010 and at least quarterly beginning in January 2011.

(2) The Office may disclose state-level and facility-level HAI data including but not limited to observed frequencies, expected frequencies, proportions, and ratios beginning in January 2010.

(3) The Office shall summarize HAI data by facilities subject to this reporting in an annual report beginning in January 2010. The Office shall publish the annual report no later than April 30 of each calendar year.

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

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

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

(7) The Office 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 Office may publish additional reports intended to serve the public’s interest.

Stat. Auth.: ORS 442.420(3)(d) & 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

409-023-0025

HAI Data Processing and Security

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

(2) The Office shall obtain hospital process measure data files from the CMS hospital compare web site at least quarterly.

(3) The Office 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 Office shall make public the methods used to calculate statistics and perform comparisons.

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

(5) The Office 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 Office;

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

(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(3)(d) & 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

409-023-0030

Prohibited Activities

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

(1) Disclosing of patient 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(3)(d) & 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

409-023-0035

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 Office shall annually evaluate the quality of data submitted, as recommended by the committee.

Stat. Auth.: ORS 442.445 & 442.420(3)(d)
Stats. Implemented: ORS 442.445
Hist.: OHP 1-2008, f. & cert. ef. 7-1-08

Community Benefit Reporting Program

409-023-0100

Definitions

The following definitions apply to OAR 409-023-0100 to 409-023-0105:

(1) “Charity care” means free or discounted health services provided to persons who cannot afford to pay and from whom a hospital has no expectation of payment. Charity care does not include bad debt, contractual allowances, or discounts for quick payment. Charity care is reported on the basis of cost, not gross charges by adjusting charges by a ratio of cost to charges (RCC).

(2) “Community” means the geographic service area and patient population that the health care institution serves as defined by the hospital.

(3) “Community benefits” mean programs or activities that provide treatment or promote health and healing as a response to identified community needs. They are not provided primarily for marketing purposes or to increase market share.

(a) Community benefit must meet at least one of the following criteria:

(A) Generate negative margin;

(B) Improve access to health services;

(D) Advance knowledge;

(E) Demonstrate charitable purpose.

(b) Community benefit activities must be counted in only one of the following categories:

(A) Charity care;

(B) Losses related to Medicaid, Medicare, State Children’s Health Insurance Program, or other publicly funded health care program shortfalls;

(D) Health professionals’ education;

(E) Subsidized health services;

(F) Research;

(G) Financial and in-kind contributions to the community;

(H) Community building activities;

(I) Community benefit operations.

(4) “Cost” means the total expense incurred by the hospital minus any offsetting revenue (e.g. grants, payments).

(5) “Hospital” has the meaning provided in ORS 442.015.

(6) “Office” means the Office for Oregon Health Policy and Research.

Stat. Auth.: ORS 442.205
Stats. Implemented: ORS 442.205, 442.011, 442.200, 442.425 & 442.445
Hist.: OHP 2-2008, f. & cert. ef. 7-1-08

409-023-0105

Reporting

(1) Hospital reporting required pursuant to this rule shall begin with hospital fiscal years beginning on or after January 1, 2008 and must be consistent with generally accepted accounting principles.

(2) The hospital must submit a community benefit report to the Office within 240 days from the close of the hospital’s fiscal year. The report will be deemed submitted as of the date the report is postmarked or electronically delivered to the Office, whichever is first.

(3) Hospitals may submit an amended report after submission of original report to the Office within 30 days of the report submittal deadline. The amended report must include a written explanation for the reason for the amendment.

(4) Hospitals that are part of a multi-hospital system may submit reports for all system hospitals in one submission, but each hospital must be separately reported and clearly identified in any submission. Nothing in this section removes the requirement that hospitals report their individual community benefit report.

(5) If the ownership of the hospital changes during the reporting year, each hospital owner shall be required to submit a community benefit report for the hospital for the portion of the year owned.

(6) Each hospital must submit, on an annual basis, a community benefit report on form CBR-1 as defined by the Office. The report must be completed in accordance with instructions published in the Community Benefit Reporting Guidelines (CBR-2). The Office shall inform each hospital subject to reporting of any changes for the subsequent year by July 1.

(a) Reporting only includes activities under the direct control and management of hospital management and occurring during the fiscal year of the report.

(b) Hospitals must not include a community benefit cost in more than one category as defined by the Community Benefit Reporting Guidelines (CBR-2). These guidelines shall be posted on the Office web site. The Office must inform each hospital subject to this reporting of any changes in guidelines for the subsequent year by July 1.

(7) A hospital may submit, in addition to the reporting required in section (6), its financial assistance policy or any additional qualitative documents it deems appropriate. Any submission should be clearly identified for explanation of one of the community benefit categories defined in CBR-1.

(8) A parent company or academic health center may submit quantitative and qualitative information about the community benefit provided by the parent company or academic health center and should comply with the definition of community benefit as defined in this rule. Any information provided should clearly identify the hospitals included.

(9) Any information provided to the Office pursuant to this reporting will be publicly available and may be included in the annual report produced by the Office.

(10) The Office shall produce and publicly report, by hospital, an annual report of the community benefit information submitted to the Office.

(11) A hospital that fails to report as required in these rules may be subject to a civil penalty not to exceed $500 per day.

Stat. Auth.: ORS 442.205
Stats. Implemented: ORS 442.205, 442.011, 442.200, 442.425 & 442.445
Hist.: OHP 2-2008, f. & cert. ef. 7-1-08

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