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Oregon Bulletin

January 1, 2011

 

Department of Human Services,
Public Health Division
Chapter 333

Rule Caption: Changes to hospital and ambulatory surgical center rules in response to passage of SB 158.

Adm. Order No.: PH 26-2010

Filed with Sec. of State: 12-14-2010

Certified to be Effective: 12-15-10

Notice Publication Date: 11-1-2010

Rules Adopted: 333-076-0250, 333-076-0255, 333-076-0260, 333-076-0265, 333-076-0270, 333-500-0031, 333-501-0060

Rules Amended: 333-076-0101, 333-076-0106, 333-076-0108, 333-076-0109, 333-076-0111, 333-076-0114, 333-076-0115, 333-076-0125, 333-076-0130, 333-076-0135, 333-076-0140, 333-076-0145, 333-076-0155, 333-076-0160, 333-076-0165, 333-076-0170, 333-076-0175, 333-076-0180, 333-076-0190, 333-500-0005, 333-500-0010, 333-500-0020, 333-500-0025, 333-500-0030, 333-500-0034, 333-500-0040, 333-500-0065, 333-501-0010, 333-501-0015, 333-501-0035, 333-501-0040, 333-501-0045, 333-501-0055, 333-505-0005, 333-505-0020, 333-505-0030, 333-505-0033, 333-505-0050

Subject: The Oregon Health Authority, Public Health Division is proposing to adopt and amend Oregon Administrative Rules relating to hospitals and ambulatory surgical centers (ASCs) in response to the passage of SB 158 during the 2009 legislative session. These rules address new fees, classification of ASCs, inspections, complaint investigations, disclosure and consent provisions, care of patients, and quality assessment and performance improvement.

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

333-076-0101

Definitions

As used in OAR chapter 333, division 76 unless the context requires otherwise, the following definitions apply:

(1) “Ambulatory Surgical Center” (ASC) means:

(a) A facility or portion of a facility that operates exclusively for the purpose of providing surgical services to patients who do not require hospitalization and for whom the expected duration of services does not exceed 24 hours following admission.

(b) Ambulatory surgical center does not mean:

(A) Individual or group practice offices of private physicians or dentists that do not contain a distinct area used for outpatient surgical treatment on a regular and organized basis, or that only provide surgery routinely provided in a physician’s or dentist’s office using local anesthesia or conscious sedation; or

(B) A portion of a licensed hospital designated for outpatient surgical treatment.

(2) “Authentication” means verification that an entry in the patient medical record is genuine.

(3) “CMS” means Centers for Medicare and Medicaid Services.

(4) “Certified ambulatory surgical center” means a facility that is licensed by the Division and is deemed as meeting the Medicare Conditions of Participation for ambulatory surgical services, 42 CFR 416, Subpart C.

(5) “Certified Nurse Anesthetist” (CRNA) means a registered nurse certified by the Council on Certification of Nurse Anesthetists and licensed by the Oregon State Board of Nursing.

(6) “Conditions of Participation” mean the applicable federal regulations that ASCs are required to comply with in order to participate in the federal Medicare and Medicaid programs.

(7) “Conscious sedation” means an induced controlled state of minimally depressed consciousness in which the patient retains the ability to independently and continuously maintain an airway and to respond purposefully to physical stimulation and to verbal command.

(8) “Deemed” means a health care facility that has been inspected by an approved accrediting organization and has been approved by the CMS as meeting CMS Conditions of Participation.

(9) “Deep sedation” means an induced controlled state of depressed consciousness in which the patient experiences a partial loss of protective reflexes, as evidenced by the inability to respond purposefully either to physical stimulation or to verbal command but the patient retains the ability to independently and continuously maintain an airway.

(10) “Direct ownership” has the meaning given the term ‘ownership interest’ in 42 CFR 420.201.

(11) “Division” means the Public Health Division of the Oregon Health Authority.

(12) “Financial interest” means a five percent or greater direct or indirect ownership interest.

(13) “General anesthesia” means an induced controlled state of unconsciousness in which the patient experiences complete loss of protective reflexes, as evidenced by the inability to independently maintain an airway, the inability to respond purposefully to physical stimulation, or the inability to respond purposefully to verbal command.

(14) “Governing body” means the body or person legally responsible for the direction and control of the operation of the facility.

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

(16) “Health Care Facility Licensing Law” means ORS 441.015-441.990 and rules thereunder.

(17) “High complexity non-certified” means a facility that is licensed by the Division, is not deemed as meeting the Medicare Conditions of Participation for ambulatory surgical services, 42 CFR 416, Subpart C, and performs surgical procedures involving deep sedation or general anesthesia.

(18) “Hospital” has the meaning given that term in ORS 442.015.

(19) “Indirect ownership” has the meaning given the term ‘indirect ownership interest’ in 42 CFR 420.201.

(20) “Licensed” means that the person or facility to whom the term is applied is currently licensed, certified or registered by the proper authority to follow his or her profession or vocation within the State of Oregon, and when applied to a health care facility means that the facility is currently and has been duly and regularly licensed by the Division.

(21) “Licensed Nurse” means a Registered Nurse (RN) or a Licensed Practical Nurse (LPN).

(22) “Licensed Practical Nurse” (LPN) means a person licensed under ORS chapter 678 to practice practical nursing.

(23) “Local anesthesia” means the administration of an agent that produces a transient and reversible loss of sensation in a circumscribed portion of the body.

(24) “Moderate complexity non-certified” means a facility licensed by the Division, is not deemed as meeting the Medicare Conditions of Participation for ambulatory surgical services, 42 CFR 416, Subpart C, and performs procedures requiring not more than conscious sedation.

(25) “New construction” means a new building or an addition to an existing building.

(26) “NFPA” means National Fire Protection Association.

(27) “Nursing Assistant” means a person certified as meeting the educational requirements established by the Oregon State Board of Nursing (OSBN). Responsibilities shall be limited to functions included in a course curricula approved by OSBN.

(28) “Patient audit” means review of the medical record and/or physical inspection of a patient.

(29) “Person” means an individual, a trust or estate, or a partnership or corporation (including associations, joint stock companies and insurance companies, a state or a political subdivision or instrumentality including a municipal corporation).

(30) “Physician” means a person licensed under ORS chapter 677 to practice medicine by the Oregon Medical Board.

(31) “Podiatrist” means a person licensed under ORS chapter 677 to practice podiatry.

(32) “Podiatry” means the diagnosis or the medical, physical or surgical treatment of ailments of the human foot, except treatment involving the use of a general or spinal anesthetic unless the treatment is performed in a hospital certified in the manner described in subsection (2) of ORS 441.055 and is under the supervision of or in collaboration with a physician licensed to practice medicine by the Oregon Medical Board. “Podiatry” does not include the administration of general or spinal anesthetics or the amputation of the foot.

(33) “Registered Nurse” (RN) means a person licensed as a Registered Nurse under ORS chapter 678.

Stat. Auth.: ORS 441.025 & 441.057

Stats. Implemented: ORS 441.020, 441.025, 441.057, 441.098, & 442.015

Hist.: HD 3-1990, f. 1-8-90, cert. ef. 1-15-90; PH 4-2006(Temp), f. & cert. ef. 3-2-06 thru 8-1-06; Administrative correction 8-22-06;PH 25-2006, f. 10-31-06, cert. ef. 11-1-06; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-076-0106

Issuance of License and Fees

(1) Application for a license to operate an ASC shall be in writing on a form provided by the Division, including demographic, ownership and administrative information. The form shall specify such information required by the Division.

(2) For purposes of determining the correct license fee required under ORS 441.020 and this rule:

(a) “Procedure room” means a room where surgery or invasive procedures are performed; and

(b) “Invasive procedure” means a procedure requiring insertion of an instrument or device into the body through the skin or a body orifice for diagnosis or treatment, and operative procedures in which skin or mucous membranes and connective tissue are incised, or an instrument is introduced through a natural body orifice.

(3) Upon receipt of an application and the license fee as described in ORS 441.020, the Division shall review the application and conduct an on-site inspection of the ASC.

(4) In lieu of an onsite inspection required under section (3) of this rule, the Division may accept:

(a) CMS certification by a federal agency or accrediting organization; or

(b) A survey conducted within the previous three years by an accrediting organization approved by the Division, if:

(A) The certification or accreditation is recognized by the Division as addressing the standards and condition of participation requirements of the CMS and other standards set by the Division and an ASC provides the Division with a letter from CMS indicating its deemed status;

(B) The ASC notifies the Division of any exit interview conducted by the federal agency or accrediting body and permits the Division to participate; and

(C) The ASC provides copies of all documentation concerning the certification or accreditation requested by the Division.

(5) If the deemed status of an ASC changes, the ASC administrator must notify the Division.

(6) No person or ASC licensed pursuant to the provisions of ORS chapter 441, shall in any manner or by any means assert, represent, offer, provide or imply that such person or facility is or may render care or services other than that which is permitted by or which is within the scope of the license issued to such person or facility by the Division nor shall any service be offered or provided which is not authorized within the scope of the license issued to such person or facility.

(7) The Division shall issue a license to an ASC that:

(a) Submits a completed application as described in section (1) of this rule;

(b) Submits the license fee as described in ORS 441.020;

(c) Successfully completes the survey requirements established in this rule or provides documentation acceptable to the Division under section (4) of this rule; and

(d) Is found by the Division to be in compliance with applicable statutes and these rules.

(8) In determining whether to license an ASC pursuant to ORS 441.025, the Division shall consider only factors relating to the health and safety of individuals to be cared for therein and the ability of the operator of the ASC to safely operate the facility, and shall not consider whether the ASC is or will be a governmental, charitable, or other nonprofit institution or whether it is or will be an institution for profit.

(9) The license shall be conspicuously posted in the area where patients are admitted.

(10) A facility license that has been suspended or revoked may be reissued after the Division determines that compliance with HCF laws has been achieved satisfactorily.

Stat. Auth.: ORS 441.025

Stats. Implemented: ORS 441.022 & 441.025

Hist.: HD 3-1990, f. 1-8-90, cert. ef. 1-15-90; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-076-0108

Expiration and Renewal of License

Each license to operate an ASC shall expire on December 31 following the date of issue, and if a renewal is desired, the licensee shall make application at least 30 days prior to the expiration date upon a form prescribed by the Division as described in OAR 333-076-0106.

Stat. Auth.: ORS 441.025

Stats. Implemented: ORS 441.025

Hist.: HD 3-1990, f. 1-8-90, cert. ef. 1-15-90; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-076-0109

Denial or Revocation of a License

(1) A license for any ASC may be denied, suspended or revoked by the Division when the Division finds that there has been a substantial failure to comply with the provisions of Health Care Facility licensing law.

(2) A person or persons in charge of an ASC shall not permit, aid or abet any illegal act affecting the welfare of the license.

(3) A license shall be denied, suspended or revoked in any case where the State Fire Marshal certifies that there was failure to comply with all applicable laws, lawful ordinances and rules relating to safety from fire.

(4) A license may be suspended or revoked for failure to comply with a Division order arising from an ASC’s substantial lack of compliance with the rules or statutes.

Stat. Auth.: ORS 441.025

Stats. Implemented: ORS 441.025 & 441.030

Hist.: HD 3-1990, f. 1-8-90, cert. ef. 1-15-90; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-076-0111

Classification

(1) Ambulatory surgical centers shall be classified as follows:

(a) Certified;

(b) High complexity non-certified; and

(c) Moderate complexity non-certified.

(2) The classification of each ASC shall be so designated on the license.

(3) ASCs licensed by the Division shall neither assume a descriptive title nor be held out under any descriptive title other than the classification title established by the Division and under which the facility is licensed. This not only applies to the name on the facility but where stationery, advertising and other representations are involved.

(4) No change in the licensed classification of any ASC, as set out in this rule, shall be allowed by the Division unless such facility shall file a new application, accompanied by the required license fee, with the Division. If the Division finds that the applicant and facility comply with HCF laws and the regulations of the Division relating to the new classification for which application for licensure is made, the Division shall issue a license for such classification.

Stat. Auth.: ORS 441.025 & 441.086

Stats. Implemented: ORS 441.025 & 441.086

Hist.: HD 3-1990, f. 1-8-90, cert. ef. 1-15-90; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-076-0114

Inspections and Complaint Investigations

(1) Complaints:

(a) Any person may make a complaint to the Division regarding violation of health care facility laws or regulations. A complaint investigation will be carried out as soon as practicable and may include but not be limited to, as applicable to facts alleged: interviews of the complainant, patient(s), witnesses, and ASC management and staff; observations of the patient(s), staff performance, patient environment and physical environment; and review of documents and records;

(b) An ASC shall post a notice in the facility, in a prominent place and size that must include, but is not limited to the following: “If you have concerns about this ambulatory surgical center and the services provided here, contact the Public Health Division, Health Care Regulation and Quality Improvement Program: 800 NE Oregon Street, Suite 305, Portland OR 97232; 971-673-0540.”

(c) Information obtained by the Division during an investigation of a complaint or reported violation is confidential and not subject to public disclosure under ORS 192.410 to 192.505. Upon the conclusion of the investigation, the Division may publicly release a report of its findings but may not include information in the report that could be used to identify the complainant or any patient at the ASC.

(d) The Division may use any information obtained during an investigation in an administrative or judicial proceeding concerning the licensing of an ASC, and may report information obtained during an investigation to a health professional regulatory board as defined in ORS 675.160 as that information pertains to a licensee of the board.

(2) Inspections:

(a) The Division will, in addition to any inspections conducted pursuant to complaint investigations, conduct at least one general inspection of each ASC to determine compliance with HCF laws at least once every three years and at such other times as the Division deems necessary. The Division may accept certificates from accrediting organizations approved by the Division as evidence of compliance with acceptable standards in lieu of ASC inspections;

(b) Facilities providing approved accrediting organization certificates as evidence of compliance shall also be required to provide to the Division (or to have previously provided) with each license application (and license renewal application):

(A) All approved accrediting organizations survey and inspection reports; and

(B) Written evidence of all corrective actions underway, or completed, in response to approved accrediting organizations recommendations; including all progress reports.

(c) Inspections will include but not be limited to those procedures stated in subsection (1)(a) of this rule;

(d) The inspection may include a patient audit, the results of which shall be summarized on the licensing survey form;

(e) When documents and records are requested under section (1) or (2) of this rule, the ASC shall make the requested materials available to the investigator for review and copying.

Stat. Auth.: ORS 441.025

Stats. Implemented: ORS 441.025, 441.060 & 441.086

Hist.: HD 3-1990, f. 1-8-90, cert. ef. 1-15-90; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-076-0115

Governing Body Responsibility

The governing body of each ASC shall be responsible for the operation of the facility, the selection of the medical staff and the quality of care rendered in the facility. The governing body shall:

(1) Insure that all health care personnel for whom state licenses or registration are required are currently licensed or registered;

(2) Insure that physicians admitted to practice in the facility are granted privileges consistent with their individual training, experience and other qualifications;

(3) Insure that procedures for granting, restricting and terminating privileges exist and that such procedures are regularly reviewed to assure their conformity to applicable law;

(4) Insure that physicians admitted to practice in the facility are organized into a medical staff insofar as applicable in such a manner as to effectively review the professional practices of the facility for the purposes of reducing morbidity and mortality and for the improvement of patient care; and

(5) Insure that a physician is not denied medical staff membership or privileges at the facility solely on the basis that the physician holds medical staff membership or privileges at another ASC.

Stat. Auth.: ORS 441.025

Stats. Implemented: ORS 441.025 & 441.055

Hist.: HD 11-1980, f. & ef. 9-10-80; HD 25-1983(Temp), f. & ef. 12-21-83; HD 23-1985, f. & ef. 10-11-85; Renumbered from 333-023-0163(1); HD 3-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0100(1)(a) & (b); PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-076-0125

Personnel

(1) As used in this rule, “person” means any:

(a) ASC employee;

(b) ASC contractor;

(c) Health care practitioner granted privileges by the ASC; or

(d) ASC volunteer or student.

(2) The facility shall maintain a sufficient number of qualified personnel to provide effective patient care and all other related services.

(3) There shall be written personnel policies and procedures which shall be made available to personnel.

(4) Provisions shall be made for orientation.

(5) Provisions shall be made for an annual continuing education plan.

(6) There shall be a job description for each position which delineates the qualifications, duties, authority and responsibilities inherent in each position.

(7) There shall be an annual work performance evaluation for each employee with appropriate records maintained.

(8) There shall be an employee health screening program for the purpose of protecting patients and employees from communicable diseases, including but not limited to requiring tuberculosis testing for employees in accordance with section (10) of this rule.

(9) An ASC shall restrict the work of employees with restrictable diseases in accordance with OAR 333-019-0010.

(10) Each ASC shall formally assess the risk of tuberculosis transmission among ASC employees, contractors, health care practitioners granted privileges by the ASC, volunteers or students, and shall comply with the “Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings,” published by the Centers for Disease Control and Prevention (Morbidity and Mortality Weekly Report, vol. 54, number RR-17, December 30, 2005 or by following recommendations otherwise approved by the Division.

(11) An ASC shall obtain documentation that tuberculosis (TB) testing has been conducted in a manner consistent with the CDC guidelines for any person who enters an ASC and who has contact with patients, enters rooms that patients may enter, or who handles clinical specimens or other material from patients or their rooms.

(a) An ASC shall require documentation of baseline TB screening conducted in accordance with the CDC Guidelines, within six weeks of the date of hire, date of executed contract or date of being granted ASC credentials.

(b) For persons hired, contracted with or granted ASC privileges prior to December 15, 2010, an ASC shall obtain documentation of compliance with CDC Guidelines by February 1, 2011.

(12) An ASC that is classified as “potential ongoing transmission” under CDC Guidelines shall consult with the Oregon TB control program within the Division, for guidance on the extent of TB testing required.

(13) If an ASC learns that a person or a patient at the hospital is diagnosed with communicable TB, the ASC shall notify the local public health authority and conduct an investigation to identify contacts. If the Division or local public health authority conducts its own investigation, an ASC shall cooperate with that investigation and provide the Division or local public health authority with any information necessary for it to conduct its investigation.

(14) An ASC shall notify the local public health administrator of its intent to discharge a patient known to have active TB disease.

(15) The actions taken under this rule and all results thereof shall be fully documented for each employee. Such documentation is subject to review by authorized representatives of the Division.

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

Stat. Auth.: ORS 441.025

Stats. Implemented: ORS 433.411, 441.025, 441.057, 441.162, 678.362

Hist.: HD 3-1990, f. 1-8-90, cert. ef. 1-15-90; PH 4-2006(Temp), f. & cert. ef. 3-2-06 thru 8-1-06; Administrative correction 8-22-06; PH 25-2006, f. 10-31-06, cert. ef. 11-1-06; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-076-0130

Policies and Procedures

The governing body shall have a formal organizational plan with written policies, procedures and by-laws that are enforced and that clearly set forth the organizational plan with written responsibilities, accountability and relationships of professional and other personnel including volunteers.

(1) The clinical services of each ASC shall be under the supervision of a manager who shall be an RN or a physician.

(2) The following are written policies and procedures that the ASC shall develop and implement:

(a) Types of procedures that may be performed in the facility;

(b) Types of anesthesia that may be used including storage procedures. Where inhalation anesthetics and medical gases are used there shall be procedures to assure safety in storage and use;

(c) Criteria for evaluating patient before admission and before discharge or transfer;

(d) Nursing service activities;

(e) Infection control;

(f) Visitor’s conduct and control;

(g) Criteria and procedures for admission of physicians, dentists, or other individuals within the scope of his or her license, to the staff;

(h) Content and form of medical records;

(i) Procedures for storage and dispensing of clean and sterile supplies and equipment and the processing and sterilizing of all supplies, instruments and equipment used in procedures unless disposable sterile packs are used;

(j) Procedures for the disposal of pathological and other potentially infectious waste and contaminated supplies. Guidelines established by the Division shall be used in developing these procedures;

(k) Procedures for the procurement, storage and dispensing of drugs;

(l) If the program calls for the serving of snacks or other foods procedures shall be written covering space, equipment and supplies. Arrangements may be made for outside services. All food services shall meet the requirements of the Food Sanitation Rules, OAR 333-150-0000;

(m) Procedures for the cleaning, storage and handling of soiled linen and the storage and handling of clean linen;

(n) Policies and procedures relating to routine laboratory testing;

(o) A policy and procedure which assures at least annual training in emergency procedures, including, but not limited to:

(A) Procedures for fire and other disaster;

(B) Infection control measures; and

(C) For staff involved in direct patient care, procedures for life threatening situations including, but not limited to, cardiopulmonary resuscitation and the life saving techniques for choking;

(p) Policies and procedures for essential life saving measures and stabilization of a patient and arrangements for transfer to an appropriate facility;

(q) Procedures for notifying patients orally and in writing of any financial interest as required by ORS 441.098;

(r) Requirements for informed consent signed by the patient or legal representative of the patient for diagnostic and treatment procedures; such policies and procedures shall address informed consent of minors in accordance with provisions in ORS 109.610, 109.640, 109.670, and 109.675; and

(s) Requirements for identifying persons responsible for obtaining informed consent and other appropriate disclosures and ensuring that the information provided is accurate.

Stat. Auth.: ORS 441.025 & 441.057

Stats. Implemented: ORS 441.025, 441.057, 441.162, & 678.362

Hist.: HD 11-1980, f. & ef. 9-10-80; HD 25-1983(Temp), f. & ef. 12-21-83; HD 23-1985, f. & ef. 10-11-85; Renumbered from 333-023-0163(1); HD 3-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0100(2)(a) & (b)(A)–(Q); PH 4-2006(Temp), f. & cert. ef. 3-2-06 thru 8-1-06; Administrative correction 8-22-06; PH 25-2006, f. 10-31-06, cert. ef. 11-1-06; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-076-0135

Nursing Services

(1) An RN shall be responsible for the nursing care provided to the patients.

(2) The number and types of nursing personnel, including RNs, LPNs and nursing and surgical assistants shall be based on the needs of the patients and the types of services performed.

(3) At least one RN and one other nursing staff member shall be on duty at all times patients are present.

(4)(a) For purposes of this rule, “circulating nurse” means a registered nurse who is responsible for coordinating the nursing care and safety needs of the patient in the operating room and who also meets the needs of operating room team members during surgery.

(b) The duties of a circulating nurse performed in an operating room of a certified or high complexity non-certified ambulatory surgical center shall be performed by a registered nurse licensed under ORS 678.010-678.410.

(c) In any case requiring anesthesia or conscious sedation, a circulating nurse shall be assigned to, and present in, an operating room for the duration of the surgical procedure unless it becomes necessary for the circulating nurse to leave the operating room as part of the surgical procedure. While assigned to a surgical procedure, a circulating nurse may not be assigned to any other patient or procedure.

(d) Nothing in this rule precludes a circulating nurse from being relieved during a surgical procedure by another circulating nurse assigned to continue the surgical procedure.

(5) Nurses who supervise the recovery area shall have current training in resuscitation techniques and other emergency procedures.

Stat. Auth.: ORS 441.025 & 441.057

Stats. Implemented: ORS 441.025, 441.057, 441.162, & 678.362

Hist.: HD 11-1980, f. & ef. 9-10-80; HD 25-1983(Temp), f. & ef. 12-21-83; HD 23-1985, f. & ef. 10-11-85; Renumbered from 333-023-0163(1); HD 3-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0100(4)(a)–(c); PH 4-2006(Temp), f. & cert. ef. 3-2-06 thru 8-1-06; Administrative correction 8-22-06; PH 25-2006, f. 10-31-06, cert. ef. 11-1-06; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-076-0140

Anesthesia Services (If Provided)

(1) General or spinal anesthesia shall be administered only by a physician or a certified nurse anesthetist. Either the physician or the CRNA shall be present for the administration of general or spinal anesthetics, during anesthesia, and the recovery of the patients when any general or spinal anesthesia is used.

(2) In all areas where flammable anesthetics are used, such rooms shall be equipped and maintained in compliance with provisions of the current issue of NFPA 99, Standard for Health Care Facilities, unless the governing body’s written policy forbids the use or storage of flammable anesthetics in the facility.

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

Stat. Auth.: ORS 441.025

Stats. Implemented: ORS 441.025

Hist.: HD 11-1980, f. & ef. 9-10-80; HD 25-1983(Temp), f. & ef. 12-21-83; HD 23-1985, f. & ef. 10-11-85; Renumbered from 333-023-0163(1); HD 3-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0100(5)(a) & (b); PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-076-0145

Storage, Disposal and Dispensing of Drugs

(1) In an ASC that does not have a pharmacy on the premises, stock quantities of prescription drugs, including local anesthetics shall be stored on the premises only when such drugs have been obtained for dispensation or administration to his/her respective patients by a physician, dentist, podiatrist or other person authorized within the scope of his/her license to so dispense or administer such drugs. Prescribed drugs already prepared for patients in the ASC may also be stored on the premises.

(2) Old medications, including special prescriptions for patients who have left the facility, shall be disposed of by incineration or other equally effective method, except narcotics and other drugs under the drug abuse law, which shall be handled in the manner prescribed by the Drug Enforcement Administration of the United States Department of Justice.

(3) Drugs shall not be administered to patients unless ordered by a physician, dentist, podiatrist or individual authorized within the scope of his or her professional license to prescribe drugs; and such order shall be in writing over the physician’s or other authorized individual’s signature or authentication.

(4) Prescription drugs dispensed by a physician shall be personally dispensed by the physician. Nonjudgmental dispensing functions may be delegated to staff assistants when the accuracy and completeness of the prescription is verified by the physician.

(5) The dispensing physician shall label prescription drugs with the following information:

(a) Name of patient;

(b) The name and address of the dispensing physician;

(c) Date of dispensing;

(d) The name of the drug. If the dispensed drug does not have a brand name, the prescription label shall indicate the generic name of the drug dispensed along with the name of the drug distributor or manufacturer, its quantity per unit and the directions for its use stated in the prescription. However, if the drug is a compound, the quantity per unit need not be stated;

(e) Cautionary statements, if any, as required by law; and

(f) When applicable, and as determined by the Oregon Board of Pharmacy, an expiration date after which the patient should not use the drug.

(6) Prescription drugs shall be dispensed in containers complying with the federal Poison Prevention Packaging Act unless the patient requests a noncomplying container.

(7) Pharmacist and pharmacy personnel providing services to the ASC are subject to ORS chapter 689 and the rules thereunder.

Stat. Auth.: ORS 441.025

Stats. Implemented: ORS 441.025

Hist.: HD 11-1980, f. & ef. 9-10-80; HD 25-1983(Temp), f. & ef. 12-21-83; HD 23-1985, f. & ef. 10-11-85; Renumbered from 333-023-0163(1); HD 3-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0100(6); PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-076-0155

Laboratory Services

(1) Laboratory services shall be available for every patient either through the use of a licensed clinical laboratory in the facility or a written contract with a licensed clinical laboratory.

(2) Any tissue removed during surgery except those exempted under OAR 333-076-0165, shall be submitted for histological examination by a pathologist. A written report of findings shall be filed in the patient’s record in accordance with 333-076-0165.

(3) OAR 333-024-0005 through 333-024-0350 shall also apply.

Stat. Auth.: ORS 441.025

Stats. Implemented: ORS 441.025

Hist.: HD 11-1980, f. & ef. 9-10-80; HD 25-1983(Temp), f. & ef. 12-21-83; HD 23-1985, f. & ef. 10-11-85; Renumbered from 333-023-0163(1); HD 3-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0100(8)(a) & (b); PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-076-0160

Care of Patients

(1) Each patient shall be evaluated for all risk factors before a surgical procedure may be performed in accordance with 42 CFR 416.42 and 416.52.

(2) Each patient shall be observed for post-operative complications under the direct supervision of a licensed registered nurse. Patients shall be observed for post-procedure complications until their conditions are stable.

(3) No medications or treatments shall be given without the order of a physician or other individual authorized within the scope of his/her license.

(4) At the time of discharge from the ASC, each patient must be evaluated by a physician, or by an anesthetist as defined by 45 CFR 410.69(b) for proper anesthesia recovery.

(5) Written instruction shall be given to patients on discharge covering signs and symptoms of complications as well as any necessary follow-up instructions for routine and/or emergency care.

(6) Each facility shall adopt and observe written patient care policies.

(7) Patient care policies shall be evaluated annually and rewritten as needed. Documentation of the evaluation is required.

Stat. Auth.: ORS 441.025

Stats. Implemented: ORS 441.025 & 441.086

Hist.: HD 11-1980, f. & ef. 9-10-80; HD 25-1983(Temp), f. & ef. 12-21-83; HD 23-1985, f. & ef. 10-11-85; Renumbered from 333-023-0163(1); HD 3-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0100(9)(a)–(e); PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-076-0165

Medical Records

(1) A medical record shall be maintained for every patient admitted for care.

(2) A legible reproducible medical record shall include at least the following (if applicable):

(a) Admitting identification data including date of admission;

(b) Chief complaint;

(c) Pertinent family and personal history;

(d) History and physical. This history and physical shall be completed no more than 30 days prior to the initiation of any procedure. Sufficient time shall be allowed between examination and the initiation of any procedure, to permit review of tests;

(e) Clinical laboratory reports as well as reports on any special examinations. (The original report shall be authenticated and recorded in the patient’s medical record.);

(f) X-ray reports shall be recorded in the medical record and shall bear the identification (authentication) of the originator of the interpretation;

(g) Signed or authenticated report of consultant when such services have been obtained;

(h) All entries in patient’s medical record must be dated, timed, and authenticated:

(A)Verification of an entry requires use of a unique identifier, i.e., signature, code, thumbprint, voice print or other means, which allows identification of the individual responsible for the entry;

(B) Verbal orders may be accepted by those individuals authorized by law and by medical staff rules and regulations and shall be countersigned or authenticated within two business days by the ordering health care practitioner or another health care practitioner who is responsible for the care of the patient;

(C) A single signature or authentication of the physician, dentist, podiatrist or other individual authorized within the scope of his or her professional license on the medical record does not suffice to cover the entire content of the record.

(i) Records of assessment and intervention, including but not limited to preprocedure vital sign records, graphic charts, medication records and appropriate personnel notes;

(j) Anesthesia record including records of anesthesia, analgesia and medications given in the course of the operation and postanesthetic condition, signed or authenticated by the person making the entry;

(k) A record of operation dictated or written immediately following surgery and including a complete description of the operation procedures and findings, postoperative diagnostic impression, and a description of the tissues and appliances, if any, removed;

(l) Postanesthesia Recovery (PAR) progress notes including but not limited to vital sign records and other appropriate clinical notes;

(m) Pathology report on tissues and appliances, if any, removed at the operation. The following tissues and appliances may be exempted from pathology exam:

(A) Specimens that, by their nature or condition, do not permit fruitful examination, including but not limited to a cataract, orthopedic appliance, foreign body, or portion of rib removed only to enhance operative exposure;

(B) Therapeutic radioactive sources, the removal of which shall be guided by radiation safety monitoring requirements;

(C) Traumatically injured members that have been amputated and for which examination for either medical or legal reasons is not deemed necessary;

(D) Specimens known to rarely, if ever, show pathological change, and the removal of which is highly visible postoperatively, including but not limited to the foreskin from circumcision of a newborn infant;

(E) Placentas that are grossly normal and have been removed in the course of operative and nonoperative obstetrics;

(F) Teeth, provided that the number, including fragments, is recorded in the medical record.

(n) Summary including final diagnosis;

(o) Date of discharge and discharge note;

(p) Autopsy report if applicable;

(q) Informed consent forms that document:

(A) The name of the ASC where the procedure or treatment was undertaken;

(B) The specific procedure or treatment for which consent was given;

(C) The name of the health care practitioner performing the procedure or administering the treatment;

(D) That the procedure or treatment, including the anticipated benefits, material risks, and alternatives was explained to the patient or the patient’s representative or why it would have been materially detrimental to the patient to do so, giving due consideration to the appropriate standards of practice of reasonable health care practitioners in the same or a similar community under the same or similar circumstances;

(E) The manner in which care will be provided in the event that complications occur that require health services beyond what the ASC has the capability to provide. If the ASC has entered into agreements with more than one hospital, the patient must be provided with the most likely possible option, but that the transfer hospital may be dependent on the type of problem encountered.

(F) The signature of the patient or the patient’s legal representative; and

(G) The date and time the informed consent was signed by the patient or the patient’s legal representative;

(r) Documentation of the disclosures required in ORS 441.098;

(s) Such signed documents as may be required by law.

(3) The completion of the medical record shall be the responsibility of the attending physician:

(a) Medical records shall be completed by the physician, dentist, podiatrist or other individual authorized within the scope of his or her professional license within four weeks following the patient’s discharge;

(b) If a patient is transferred to another health care facility, transfer information shall accompany the patient. Transfer information shall include but not be limited to facility from which transferred, name of physician to assume care, date and time of discharge, current medical findings, current nursing assessment, current history and physical, diagnosis, orders from a physician for immediate care of the patient, operative report, if applicable; TB test, if applicable; other information germane to patient’s condition. If discharge summary is not available at time of transfer, it shall be transmitted as soon as available.

(4) Diagnoses and operations shall be expressed in standard terminology.

(5) The medical records shall be filed in a manner which renders them easily retrievable. Medical records shall be protected against unauthorized access, fire, water and theft.

(6) Medical records are the property of the ASC. The medical record, either in original, electronic or microfilm form, shall not be removed from the institution except where necessary for a judicial or administrative proceeding. Authorized personnel of the Division shall be permitted to review medical records. When an ASC uses off-site storage for medical records, arrangements must be made for delivery of these records to the health care facility when needed for patient care or other health care facility activities. Precautions must be taken to protect patient confidentiality.

(7) All medical records shall be kept for a period of at least 10 years after the date of last discharge. Original medical records may be retained on paper, microfilm, electronic or other media.

(8) If an ASC changes ownership all medical records in original, electronic or microfilm form shall remain in the ASC or related institution, and it shall be the responsibility of the new owner to protect and maintain these records.

(9) If any ASC shall be finally closed, its medical records may be delivered and turned over to any other health care facility in the vicinity willing to accept and retain the same as provided in section (7) of this rule.

(10) All original clinical records or photographic or electronic facsimile thereof, not otherwise incorporated in the medical record, such as x-rays, electrocardiograms, electroencephalograms, and radiological isotope scans shall be retained for seven years after patient’s last discharge if professional interpretations of such graphics are included in the medical records.

(11) A current written policy on the release of medical record information including patient access to his/her medical record shall be maintained in the facility.

(12) The Division may require the facility to obtain periodic and at least annual consultation from a qualified medical records consultant, RHIA/RHIT. The visits of the medical records consultant shall be of sufficient duration and frequency to review medical record systems and assure quality records of the patients. Contract for such services shall be available to the Division upon request.

Stat. Auth.: ORS 441.025

Stats. Implemented: ORS 441.025

Hist.: HD 3-1990, f. 1-8-90, cert. ef. 1-15-90; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-076-0170

Quality Assessment and Performance Improvement

(1) The governing body of an ASC must ensure that there is an effective, facility-wide quality assessment and performance improvement program that demonstrates measurable improvement in patient health outcomes, and improves patient safety by using quality indicators or performance measures associated with improved health outcomes and by the identification and reduction of medical errors.

(2) The ASC must measure, analyze, and track quality indicators, adverse patient events, infection control and other aspects of performance that includes care and services furnished in the ASC. Written documentation of quality assessment and performance improvement activities shall be recorded at least quarterly.

(3) After an analysis of the causes for adverse events, the ASC must develop and implement facility-wide preventive strategies and ensure that staff are trained in and familiar with these strategies.

(4) The ASC must set priorities for its performance improvement activities that:

(a) Focus on high risk, high volume and problem prone areas;

(b) Consider incidence, prevalence and severity of problems in those areas; and

(c) Affect health outcomes, patient safety and quality of care.

(5) An ASC already in operation and not certified by CMS on December 15, 2010 must be in compliance with this section by June 15, 2011.

Stat. Auth.: ORS 441.025

Stats. Implemented: ORS 441.025

Hist.: HD 3-1990, f. 1-8-90, cert. ef. 1-15-90; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-076-0175

Infection Control

(1) Each ASC shall establish and maintain an active facility-wide infection control program for the control and prevention of infection. The program shall be managed by a qualified individual and overseen by a multi-disciplinary committee which shall be responsible for investigating, controlling and preventing infections in the facility.

(2) Each ASC shall be responsible for developing written policies and for annual review of such policies, relating to at least the following:

(a) Identification of existing or potential infections in patients, employees, medical staff, and health care practitioners with ASC privileges;

(b) Control of factors affecting the transmission of infections and communicable diseases;

(c) Provisions for orienting and educating all employees, medical staff, health care practitioners with ASC privileges and volunteers on the cause, transmission, and prevention of infections;

(d) Collection, analysis, and use of data relating to infections in the ASC.

(3) Each ASC shall be responsible for the development, implementation and annual review of policies under section (2) of this rule.

(4) An ASC shall comply with all rules of the Division for the control of communicable diseases.

(5) Written isolation procedures in accordance with current Universal Precautions for Prevention of Transmission of HIV and Other Bloodborne Infections shall be established and followed by all ASC personnel for control and prevention of cross-infection. Guidelines can be obtained from U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Atlanta, GA 30333. Any guidelines published and distributed by the Division shall also be taken into consideration.

Stat. Auth.: ORS 441.025

Stats. Implemented: ORS 441.025

Hist.: HD 3-1990, f. 1-8-90, cert. ef. 1-15-90; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-076-0180

Inservice Training for Nurses

(1) Each year the inservice training agenda for nurses shall include at least the following:

(a) Infection control measures;

(b) Emergency procedures including, but not limited to, procedures for fire and other disaster;

(c) Procedures for life-threatening situations including, but not limited to, cardiopulmonary resuscitation and the life-saving techniques for choking victims; and

(d) Other special needs of the patient population.

(2) The facility shall assure that each licensed/certified employee is knowledgeable of the laws/rules governing his/her performance and that employees function within those performance standards.

(3) Documentation of such training shall include the date, content, duration and names of attendees.

Stat. Auth.: ORS 441.025

Stats. Implemented: ORS 441.025

Hist.: HD 3-1990, f. 1-8-90, cert. ef. 1-15-90; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-076-0190

Emergency Preparedness

(1) The ASC shall develop, maintain, update, train and exercise an emergency plan for the protection of all individuals in the event of an emergency, in accordance with the regulations as specified in Oregon Fire Code (Oregon Administrative Rules chapter 837, division 40).

(a) The ASC shall conduct at least two drills every year that document and demonstrate that employees have practiced their specific duties and assignments, as outlined in the emergency preparedness plan.

(2) The emergency plan shall include the contact information for local emergency management. Each facility shall have documentation that the local emergency management office has been contacted and that the facility has a list of local hazards identified in the county hazard vulnerability analysis.

(3) The summary of the emergency plan shall be sent to the Division within one year of the filing of this rule. New facilities that have submitted licensing documents to the state before this provision goes into effect will have one year from the date of license application to submit their plan. All other new facilities shall have a plan prior to licensing. The Division shall request updated plans as needed.

(4) The emergency plan shall address all local hazards that have been identified by local emergency management that may include, but is not limited to, the following:

(a) Chemical emergencies;

(b) Dam failure;

(c) Earthquake;

(d) Fire;

(e) Flood;

(f) Hazardous material;

(g) Heat;

(h) Hurricane;

(i) Landslide;

(j) Nuclear power plant emergency;

(k) Pandemic;

(l) Terrorism; or

(m) Thunderstorms.

(5) The emergency plan shall address the availability of sufficient supplies for staff and patients to shelter in place or at an agreed upon alternative location for a minimum of two days, in coordination with local emergency management, under the following conditions:

(a) Extended power outage;

(b) No running water;

(c) Replacement of food or supplies is unavailable;

(d) Staff members do not report to work as scheduled; and

(e) The patient is unable to return to the pre-treatment shelter.

(6) The emergency plan shall address evacuation, including:

(a) Identification of individual positions’ duties while vacating the building, transporting, and housing residents;

(b) Method and source of transportation;

(c) Planned relocation sites;

(d) Method by which each patient will be identified by name and facility of origin by people unknown to them;

(e) Method for tracking and reporting the physical location of specific patients until a different entity resumes responsibility for the patient; and

(f) Notification to the Division about the status of the evacuation.

(7) The emergency plan shall address the clinical and medical needs of the patients, including provisions to provide:

(a) Storage of and continued access to medical records necessary to obtain care and treatment of patients, and the use of paper forms to be used for the transfer of care or to maintain care on-site when electronic systems are not available.

(b) Continued access to pharmaceuticals, medical supplies and equipment, even during and after an evacuation; and

(c) Alternative staffing plans to meet the needs of the patients when scheduled staff members are unavailable. Alternative staffing plans may include, but is not limited to, on-call staff, the use of travelers, the use of management staff, or the use of other emergency personnel.

(8) The emergency plan shall be made available as requested by the Division and during licensing and certification surveys. Each plan will be re-evaluated and revised as necessary or when there is a significant change in the facility or population of the ASC.

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

Stat. Auth.: ORS 441.025

Stats. Implemented: ORS 441.025

Hist.: PH 13-2008, f. & cert. ef. 8-15-08; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-076-0250

Violations

In addition to non-compliance with any health care facility licensing law or condition of participation, it is a violation to:

(1) Refuse to cooperate with an investigation or survey, including but not limited to failure to permit Division staff access to the ASC, its documents or records;

(2) Fail to implement an approved plan of correction;

(3) Fail to comply with all applicable laws, lawful ordinances and rules relating to safety from fire;

(4) Refuse or fail to comply with an order issued by the Division;

(5) Refuse or fail to pay a civil penalty; or

(6) Fail to comply with rules governing the storage of medical records following the closure of an ASC.

Stat. Auth.: ORS 441.025

Stats. Implemented: ORS 441.015, 441.025 & 441.030

Hist.: PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-076-0255

Informal Enforcement

(1) If, during an investigation or survey Division staff document violations of health care facility licensing laws or conditions of participation, the Division may issue a statement of deficiencies that cites the law alleged to have been violated and the facts supporting the allegation.

(2) A signed plan of correction must be received by the Division within 10 business days from the date the statement of deficiencies was mailed to the ASC. A signed plan of correction will not be used by the Division as an admission of the violations alleged in the statement of deficiencies.

(3) An ASC shall correct all deficiencies within 60 days from the date of the exit conference, unless an extension of time is requested from the Division. A request for such an extension shall be submitted in writing and must accompany the plan of correction.

(4) The Division shall determine if a written plan of correction is acceptable. If the plan of correction is not acceptable to the Division, the Division shall notify the ASC administrator 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 to the administrator.

(5) If the ASC does not come into compliance by the date of correction reflected on the plan of correction or 60 days from date of the exit conference, whichever is sooner, the Division may propose to deny, suspend, or revoke the ASC license, or impose civil penalties.

Stat. Auth.: ORS 441.025

Stats. Implemented: ORS 441.015 & 441.025

Hist.: PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-076-0260

Formal Enforcement

(1) If, during an investigation or survey Division staff document substantial failure to comply with health care facility licensing laws, conditions of participation or if an ASC fails to pay a civil penalty imposed under ORS 441.170, the Division may issue a Notice of Proposed Suspension or Notice of Proposed Revocation in accordance with ORS 183.411 through 183.470.

(2) The Division may issue a Notice of Imposition of Civil Penalty for violations of health care facility licensing laws.

(3) At any time the Division may issue a Notice of Emergency License Suspension under ORS 183.430(2).

(4) If the Division revokes an ASC license, the order shall specify when, if ever, the ASC may reapply for a license.

Stat. Auth.: ORS 441.025

Stats. Implemented: ORS 441.015, 441.025, 441.030 & 441.037

Hist.: PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-076-0265

Civil Penalties, Generally

(1) A licensee that violates a health care facility licensing law, including OAR 333-076-0250 (violations), is subject to the imposition of a fine not to exceed $500 per day per violation.

(2) In addition to the penalties under section (1) of this rule, civil penalties may be imposed for violations of ORS 441.015 to 441.063, 441.086 or program rules.

(3) In determining the amount of a civil penalty the Division shall consider whether:

(a) The Division made repeated attempts to obtain compliance;

(b) The licensee has a history of noncompliance with health care facility licensing laws;

(c) The violation poses a serious risk to the public’s health;

(d) The licensee gained financially from the noncompliance; and

(e) There are mitigating factors, such as a licensee’s cooperation with an investigation or actions to come into compliance.

(4) The Division shall document its consideration of the factors in section (3) of this rule.

(5) Each day a violation continues is an additional violation.

(6) A civil penalty imposed under this rule shall comply with ORS 183.745.

Stat. Auth.: ORS 441.025

Stats. Implemented: ORS 441.030 & 441.990

Hist.: PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-076-0270

Approval of Accrediting Organizations

(1) An accrediting organization must request approval by the Division to ensure that ASCs meet state licensing standards.

(2) An accrediting organization shall request approval in writing and shall provide, at a minimum:

(a) Evidence that it is recognized as a deemed accrediting organization by CMS; or

(b) If the accrediting organization is not a deemed organization under CMS, provide:

(A) Documentation of program policies and procedures that its accreditation process meets state licensing standards;

(B) Accreditation history; and

(C) References from a minimum of two health care facilities currently receiving services from the organization.

(3) If the Division finds that an accrediting organization has the necessary qualifications to certify that state licensing standards have been met, the Division will enter into an agreement with the accrediting organization permitting it to accredit ASCs in Oregon.

Stat. Auth.: ORS 441.025

Stats. Implemented: ORS 441.062

Hist.: PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-500-0005

Applicability

Unless a specific rule provides otherwise, OAR 333-500 through 535 apply to a hospital classified as general, low occupancy acute care, orthopedic, or psychiatric or mental and do not apply to a hospital classified as a special inpatient care facility.

Stat. Auth.: ORS 441.025

Stats. Implemented: ORS 441.025

Hist.: PH 11-2009, f. & cert. ef. 10-1-09; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-500-0010

Definitions

As used in OAR chapter 333, divisions 500 through 535, unless the context requires otherwise, the following definitions apply:

(1) “Assessment” means a complete nursing assessment, including:

(a) The systematic and ongoing collection of information to determine an individual’s health status and need for intervention;

(b) A comparison with past information; and

(c) Judgment, evaluation, or a conclusion that occurs as a result of subsections (a) and (b) of this definition.

(2) “Authentication” means verification that an entry in the patient medical record is genuine.

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

(4) “Certified Nursing Assistant” (CNA) means a person who is certified by the Oregon State Board of Nursing (OSBN) to assist licensed nursing personnel in the provision of nursing care.

(5) “Chiropractor” means a person licensed under ORS chapter 684 to practice chiropractic.

(6) “Conditions of Participation” mean the applicable federal regulations that hospitals are required to comply with in order to participate in the federal Medicare and Medicaid programs.

(7) “Deemed” means a health care facility that has been inspected by an approved accrediting organization and has been approved by the Centers for Medicare and Medicaid Services (CMS) as meeting CMS Conditions of Participation.

(8) “Discharge” means the release of a person who was an inpatient of a hospital and includes:

(a) The release and transfer of a newborn to another facility, but not a transfer between acute care departments of the same facility;

(b) The release of a person from an acute care section of a hospital for admission to a long-term care section of a facility;

(c) Release from a long-term care section of a facility for admission to an acute care section of a facility;

(d) A patient who has died; and

(e) An inpatient who leaves a hospital for purposes of utilizing non-hospital owned or operated diagnostic or treatment equipment, if the person does not return as an inpatient of the same health care facility within a 24-hour period.

(9) “Direct ownership” has the meaning given the term ‘ownership interest’ in 42 CFR 420.201.

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

(11) “Emergency Medical Services” means medical services that are usually and customarily available at the respective hospital and that must be provided immediately to sustain a person’s life, to prevent serious permanent disfigurement or loss or impairment of the function of a bodily member or organ, or to provide care to a woman in labor where delivery is imminent if the hospital is so equipped and, if the hospital is not equipped, to provide necessary treatment to allow the woman to travel to a more appropriate facility without undue risk of serious harm.

(12) “Financial interest” means a five percent or greater direct or indirect ownership interest.

(13) “Full compliance survey” means a survey conducted by the Division following a complaint investigation to determine a hospital’s compliance with the CMS Conditions of Participation.

(14) “Governing body” means the body or person legally responsible for the direction and control of the operation of the hospital.

(15) “Governmental unit” has the meaning given that term in ORS 442.015.

(16) “Health care facility” (HCF) has the meaning given the term in ORS 442.015.

(17) “Health Care Facility Licensing Laws” means ORS 441.005 through 441.990 and its implementing rules.

(18) “Hospital” has the meaning given that term in ORS 442.015.

(19) “Indirect ownership” has the meaning given the term ‘indirect ownership interest’ in 42 CFR 420.201.

(20) “Licensed” means that the person to whom the term is applied is currently licensed, certified or registered by the proper authority to follow his or her profession or vocation within the State of Oregon, and when applied to a hospital means that the facility is currently licensed by the Authority.

(21) “Licensed nurse” means a nurse licensed under ORS chapter 678 to practice registered or practical nursing.

(22) “Licensed Practical Nurse” means a nurse licensed under ORS chapter 678 to practice practical nursing.

(23) “Major alteration” means any structural change to the foundation, roof, floor, or exterior or load bearing walls of a building, or the extension of an existing building to increase its floor area. Major alteration also means the extensive alteration of an existing building such as to change its function and purpose, even if the alteration does not include any structural change to the building.

(24) “Manager” means a person who:

(a) Has authority to direct and control the work performance of nursing staff;

(b) Has authority to take corrective action regarding a violation of law or a rule or a violation of professional standards of practice, about which a nursing staff has complained; or

(c) Has been designated by a hospital to receive the notice described in ORS 441.174(2).

(25) “Minor alteration” means cosmetic upgrades to the interior or exterior of an existing building, such as but not limited to wall finishes, floor coverings and casework.

(26) “Mobile satellite” means a MRI, CAT Scan, Lithotripsy Unit, Cath Lab, or other such modular outpatient treatment or diagnostic unit that is capable of being moved, is housed in a vehicle with a vehicle identification number (VIN), and does not remain on a hospital campus for more than 180 days in any calendar year.

(27) “NFPA” means National Fire Protection Association.

(28) “Nurse Midwife/Nurse Practitioner” means a registered nurse certified by the OSBN as a nurse midwife/nurse practitioner.

(29) “Nurse Practitioner” has the meaning given that term in ORS 678.010.

(30) “Nursing staff” means a registered nurse, a licensed practical nurse, or other assistive nursing personnel.

(31) “OB Unit” means a dedicated obstetrical unit that meets the requirements of OAR 333-535-0120.

(32) “On-call” means a scheduled state of availability to return to duty, work-ready, within a specified period of time.

(33) “Oregon Sanitary Code” means the Food Sanitation Rules in OAR 333-150-0000.

(34) “Patient audit” means review of the medical record and/or physical inspection and/or interview of a patient.

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

(36) “Physician” has the meaning given that term in ORS 677.010.

(37) “Physician Assistant” has the meaning given that term in ORS 677.495.

(38) “Plan of correction” means a document executed by a hospital in response to a statement of deficiency issued by the Division that describes with specificity how and when deficiencies of health care licensing laws or conditions of participation shall be corrected.

(39) “Podiatrist” has the same meaning as “podiatric physician and surgeon” in ORS 677.010.

(40) “Podiatry” means the diagnosis or the medical, physical or surgical treatment of ailments of the human foot, except treatment involving the use of a general or spinal anesthetic unless the treatment is performed in a licensed hospital or in a licensed ambulatory surgical center and is under the supervision of or in collaboration with a physician. “Podiatry” does not include the administration of general or spinal anesthetics or the amputation of the foot.

(41) “Public body” has the meaning given that term in ORS 30.260.

(42) “Registered Nurse” means a person licensed under ORS chapter 678 to practice registered nursing.

(43) “Respite care” means care provided in a temporary, supervised living arrangement for individuals who need a protected environment, but who do not require acute nursing care or acute medical supervision.

(44) “Retaliatory action” means the discharge, suspension, demotion, harassment, denial of employment or promotion, or layoff of a nursing staff person directly employed by the hospital, or other adverse action taken against a nursing staff person directly employed by the hospital in the terms or conditions of employment of the nursing staff person, as a result of filing a complaint.

(45) “Satellite” means a building or part of a building owned or leased by a hospital, and operated by a hospital, through which the hospital provides outpatient diagnostic, therapeutic, or rehabilitative services in a geographically separate location from the hospital, with a separate physical address from the hospital, but that is within 35 miles from the hospital.

(46) “Special Inpatient Care Facility” means a facility with inpatient beds and any other facility designed and utilized for special health care purposes that may include but is not limited to a rehabilitation center, a facility for the treatment of alcoholism or drug abuse, a freestanding hospice facility, or an inpatient facility meeting the requirements of ORS 441.065, and any other establishment falling within a classification established by the Division, after determination of the need for such classification and the level and kind of health care appropriate for such classification.

(47) “Stable newborn” means a newborn who is four or more hours postdelivery and who is free from abnormal vital signs, color, activity, muscle tone, neurological status, weight, and maternal-child interaction.

(48) “Stable postpartum patient” means a postpartum mother who is four hours or more postpartum and who is free from any abnormal fluctuations in vital signs, has vaginal flow within normal limits, and who can ambulate, be independent in self care, and provide care to her newborn infant, if one is present.

(49) “Statement of deficiencies” means a document issued by the Division that describes a hospital’s deficiencies in complying with health care facility licensing laws or conditions of participation.

(50) “Survey” means an inspection of a hospital to determine the extent to which a hospital is in compliance with health facility licensing laws and conditions of participation.

Stat. Auth.: ORS 441.025

Stats. Implemented: ORS 441.025

Hist.: HB 183, f. & ef. 5-26-66; HB 209, f. 12-18-68; HD 11, f. 3-16-72, ef. 4-1-72; HD 11-1980, f. & ef. 9-10-80, HD 8-1985, f. & ef. 5-17-85; Renumbered from 333-023-0114; HD 13-1987, f. 9-1-87, ef. 9-15-87; HD 23-1987(Temp), f. 11-27-87, ef. 10-15-87 through 4-15-88; HD 10-1988, f. & cert. ef. 5-27-88; HD 29-1988, f. 12-29-88, cert. ef. 1-1-89, Renumbered from 333-070-0000; HD 21-1993, f. & cert. ef. 10-28-93; HD 30-1994, f. & cert. ef. 12-13-94; OHD 2-2000, f. & cert. ef. 2-15-00; OHD 20-2002, f. & cert. ef. 12-10-02; PH 11-2009, f. & cert. ef. 10-1-09; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-500-0020

Application for Hospital License

(1) An applicant wishing to apply for a license to operate a hospital shall submit an application on a form prescribed by the Division and pay the applicable fee as specified in OAR 333-500-0030.

(2) A single hospital license may cover more than one building if the applicant meets the requirements in OAR 333-500-0025.

(3) If the applicant is proposing a new hospital the applicant shall also submit evidence of plans review approval as required by OAR chapter 333, division 675.

(4) An applicant that has a certificate of accreditation and deemed status for Medicare certification from the Joint Commission or an accrediting organization approved by the Division shall provide the certificate to the Division with its license application, and shall include:

(a) All Joint Commission or approved accrediting organization survey and inspection reports; and

(b) Written evidence of all corrective actions underway, or completed, in response to Joint Commission or approved accrediting organization recommendations, including all progress reports.

(5) No license shall be issued for any hospital for which a certificate of need is required, unless a certificate of need has first been issued under ORS 442.315.

Stat. Auth.: ORS 441.025

Stats. Implemented: ORS 441.020

Hist.: HB 183, f. & ef. 5-26-66; HB 222, f. 8-26-69, ef. 8-26-69; HD 11, f. 3-16-72, ef. 4-1-72; HD 11-1980, f. & ef. 9-10-80; Renumbered from 333-023-0116; HD 21-1985, f. & ef. 10-4-85; HD 29-1988, f. 12-29-88, cert. ef. 1-1-89, Renumbered from 333-070-0005; HD 21-1993, f. & cert. ef. 10-28-93; OHD 2-2000, f. & cert. ef. 2-15-00; PH 11-2009, f. & cert. ef. 10-1-09; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-500-0025

Indorsement of Satellite Operations

(1) The Division may indorse, under a hospital’s license, a satellite or mobile satellite of a hospital.

(2) In order for a satellite to be indorsed under a hospital’s license, the applicant or licensee shall pay the appropriate fee and provide evidence to the Division that:

(a) The satellite meets the requirements in OAR 333-500 – 535;

(b) The services at the satellite are integrated with the hospital;

(c) The financial operations of the satellite are integrated with the hospital;

(d) The hospital and the satellite have the same governing body;

(e) The satellite is under the ownership and control of the hospital;

(f) Staff at the satellite have privileges at the hospital; and

(g) Medical records of the satellite are integrated with the hospital into a unified system.

(3) A satellite shall be subject to a plans review and must pass life safety code requirements.

(4) In order for a mobile satellite to be indorsed under a hospital’s license, the applicant or licensee shall pay the appropriate fee and provide evidence to the Division that:

(a) The mobile satellite is operated in whole or in part by the hospital through lease, ownership or other arrangement;

(b) The services at the mobile satellite are integrated with the hospital;

(c) The financial operations of the mobile satellite are integrated with the hospital;

(d) The mobile satellite is physically separate from the hospital and other buildings on the hospital campus by at least 20 feet; and

(e) It meets the 2000 NFPA 101 Life Safety Code for mobile units.

(5) A mobile satellite shall keep and provide to the Division and the Fire Marshal upon request, a log that shows where the mobile satellite is located every day of the year, and its use. A copy of the log shall be kept in the mobile satellite at all times.

(6) A hospital that has a satellite that provides inpatient services that is indorsed under its license as of October 1, 2009, may continue to have that satellite indorsed under its license. After October 1, 2009, as is consistent with the definition of satellite and mobile satellite, only a satellite or mobile satellite that provides outpatient services shall be eligible for indorsement.

Stat. Auth.: ORS 441.025

Stats. Implemented: ORS 441.020

Hist.: PH 11-2009, f. & cert. ef. 10-1-09; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-500-0030

Annual License Fee

(1) The annual license fee for a hospital is as specified in ORS 441.020.

(2) If a hospital license covers a satellite or mobile satellite approved by the Division under OAR 333-500-0025, the applicable license fee shall be the sum of the license fees which would be applicable if each location or unit was separately licensed.

(3) The Authority may charge a reduced hospital fee or hospital satellite fee if the Division determines that charging the standard fee constitutes a significant financial burden.

Stat. Auth.: ORS 441.025

Stats. Implemented: ORS 441.020

Hist.: HD 11, f. 3-16-72, ef. 4-1-72; HD 143(Temp), f. & ef. 8-4-77; HD 147, f. & ef. 12-2-77; HD 15-1978(Temp), f. 11-17-78, ef. 1-1-79; HD 3-1979 f. & ef. 2-26-79; HD 11-1980, f. & ef. 9-1-80; HD 22-1982(Temp), f. & ef. 11-9-82; HD 4-1984, f. & ef. 2-16-84; Renumbered from 333-023-0117; HD 23-1987 (Temp), f. 11-27-87, ef. 10-15-87 thru 4-15-88; HD 10-1988, f. & cert. ef. 5-27-88; HD 29-1988, f. 12-29-88, cert. ef. 1-1-89; Renumbered from 333-070-0010; HD 21-1993, f. & cert. ef. 10-28-93; OHD 2-2000, f. & cert. ef. 2-15-00; OHD 12-2001, f. & cert. ef. 6-12-01; PH 11-2009, f. & cert. ef. 10-1-09; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-500-0031

Fees for Complaint Investigations and Compliance Surveys

(1) In addition to an annual fee, the Division may charge a hospital a fee for:

(a) A complaint investigation, in an amount not to exceed $850;

(b) A full compliance survey, in an amount not to exceed $7,520;

(c) An on-site follow-up survey to verify compliance with a plan of correction, in an amount not to exceed $225; and

(d) An off-site follow-up survey to verify compliance with a plan of correction, in an amount not to exceed $85.

(2) During one calendar year, the Division may charge to all hospitals a total amount not to exceed:

(a) $91,000 for complaint investigations;

(b) $15,000 for full compliance surveys; and

(c) $6,700 for follow-up surveys.

(3)(a) The Division shall apportion the total amount charged under section (2) of this rule among hospitals at the end of each calendar year based on the number of complaint investigations, full compliance surveys and follow-up surveys performed at each hospital during the calendar year.

(b) The Division may not include investigations of employee complaints in a hospital’s total number of complaint investigations.

(c) A hospital that was licensed in 2008 may not be charged fees under this subsection for more complaint investigations than the number of complaint investigations that occurred at the hospital in 2008.

(d) A hospital that was not licensed in 2008 may be charged fees under this subsection for an unlimited number of complaint investigations.

Stat. Auth.: ORS 441.025

Stats. Implemented: ORS 441.021

Hist.: PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-500-0034

Application Review

(1) In reviewing an application for a new hospital the Division shall:

(a) Verify compliance with the applicable sections of ORS chapters 441 and 476, and OAR 333-500 through 535, 675, and chapter 837;

(b) Determine whether a certificate of need is required and was obtained;

(c) Conduct an on-site licensing survey in coordination with the State Fire Marshal’s Office; and

(d) Verify compliance with conditions of participation if the applicant has requested Medicare or Medicaid certification.

(2) In determining whether to license a hospital the Division shall consider factors relating to the health and safety of individuals to be cared for at the hospital and the ability of the operator of the hospital to safely operate the facility, and may not consider whether the hospital is or shall be a governmental, charitable or other nonprofit institution or whether it is or shall be an institution for profit.

Stat. Auth.: ORS 441.025

Stats. Implemented: ORS 441.022, 441.025

Hist.: PH 11-2009, f. & cert. ef. 10-1-09; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-500-0040

Expiration and Renewal of License

(1) Each license to operate a hospital shall expire on December 31 following the date of issue, and if a renewal is desired, the licensee shall make application and pay the appropriate fee at least 30 days prior to the expiration date upon a form prescribed by the Division.

(2) For emergency preparedness planning and licensing purposes, a licensee shall provide, in its application for license renewal:

(a) The number of beds currently in use or capable of being used;

(b) The total number of beds that could be used with only minor alterations, taking into consideration existing equipment, the ancillary service capability of the facility, and the physical environment required by OAR 333-500 through 535, as applicable; and

(c) The number of beds to be licensed.

(3) A single hospital license may cover more than one location if the licensee meets the requirements in OAR 333-500-0025.

(4) An applicant that has a certificate of accreditation and deemed status for Medicare certification from the Joint Commission or an accrediting organization approved by the Division shall provide the certificate to the Division with its renewal application, and shall include:

(a) All Joint Commission or approved accrediting organization survey and inspection reports; and

(b) Written evidence of all corrective actions underway, or completed, in response to Joint Commission or approved accrediting organization recommendations, including all progress reports.

(5) If an applicant wishes to renew its license and increase the number of beds licensed from the previous licensing year, the applicant shall include:

(a) Evidence of plans review approval as required by OAR 333-535 and 675 as applicable; and

(b) Evidence that a certificate of need was obtained, or is not required.

(6) The Division may not renew a license for any hospital if a certificate of need is required and has not been obtained pursuant to ORS 442.315.

(7) If the Division intends to deny a license renewal application, it shall issue of Notice of Proposed Denial of License Renewal Application in accordance with ORS 183.411 through 183.470.

Stat. Auth.: ORS 441.025

Stats. Implemented: ORS 441.025

Hist.: HB 183, f. & ef. 5-26-66; HD 11, f. 3-16-72, ef. 4-1-72; HD 150(Temp), f. & ef. 12-15-77; HD 4-1978, f. & ef. 3-31-78; HD 11-1980, f. & ef. 9-2-80; Renumbered from 333-023-0118; HD 29-1988, f. 12-29-88, cert. ef. 1-1-89, Renumbered from 333-070-0015; PH 11-2009, f. & cert. ef. 10-1-09; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-500-0065

Waivers

(1) While all hospitals are required to maintain continuous compliance with the Division’s rules, these requirements do not prohibit the use of alternative concepts, methods, procedures, techniques, equipment, facilities, personnel qualifications or the conducting of pilot projects or research. A request for a waiver from a rule must be:

(a) Submitted to the Division in writing;

(b) Identify the specific rule for which a waiver is requested;

(c) The special circumstances relied upon to justify the waiver;

(d) What alternatives were considered, if any and why alternatives (including compliance) were not selected;

(e) Demonstrate that the proposed waiver is desirable to maintain or improve the health and safety of the patients, to meet the individual and aggregate needs of patients, and shall not jeopardize patient health and safety; and

(f) The proposed duration of the waiver.

(2) Upon finding that the hospital has satisfied the conditions of this rule, the Division may grant a waiver.

(3) A hospital may not implement a waiver until it has received written approval from the Division.

(4) During an emergency the Division may waive a rule that a hospital is unable to meet, for reasons beyond the hospital’s control. If the Division waives a rule under this section it shall issue an order, in writing, specifying which rules are waived, which hospitals are subject to the order, and how long the order shall remain in effect.

Stat. Auth.: ORS 441.025

Stats. Implemented: ORS 441.025

Hist.: PH 11-2009, f. & cert. ef. 10-1-09; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-501-0010

Investigations

(1) As soon as practicable after receiving a complaint, taking into consideration the nature of the complaint, Division staff will begin an investigation.

(2) A hospital shall permit Division staff access to the facility during an investigation.

(3) An investigation may include but is not limited to:

(a) Interviews of the complainant, patients of the hospital, patient family members, witnesses, hospital management and staff;

(b) On-site observations of patients, staff performance, and the physical environment of the hospital; and

(c) Review of documents and records.

(4) Except as otherwise specified in 42 CFR ¦ 401, Subpart B, information obtained by the Division during an investigation of a complaint or reported violation under this section is confidential and not subject to public disclosure under ORS 192.410 to 192.505. Upon the conclusion of the investigation, the Division may publicly release a report of its findings but may not include information in the report that could be used to identify the complainant or any patient at the health care facility. The Division may use any information obtained during an investigation in an administrative or judicial proceeding concerning the licensing of a health care facility, and may report information obtained during an investigation to a health professional regulatory board as defined in ORS 676.160 as that information pertains to a licensee of the board.

Stat. Auth.: ORS 441.025

Stats. Implemented: ORS 441.057

Hist.: PH 11-2009, f. & cert. ef. 10-1-09; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-501-0015

Surveys

(1) The Division shall, in addition to any investigations conducted under OAR 333-501-0010, conduct at least one on-site licensing survey of each hospital every three years to determine compliance with health care facility licensing laws and at such other times as the Division deems necessary.

(2) In lieu of an onsite inspection required under section (1) of this rule, the Division may accept:

(a) CMS certification by a federal agency or an approved accrediting organization; or

(b) A survey conducted within the previous three years by an accrediting organization approved by the Division, if:

(A) The certification or accreditation is recognized by the Division as addressing the standards and condition of participation requirements of the CMS and other standards set by the Division. Health care facilities must provide the Division with the letter from CMS indicating its deemed status;

(B) The health care facility notifies the Division to participate in any exit interview conducted by the federal agency or accrediting body; and

(C) The health care facility provides copies of all documentation concerning the certification or accreditation requested by the Division.

(3) A hospital shall permit Division staff access to the facility during a survey.

(4) A survey may include but is not limited to:

(a) Interviews of patients, patient family members, hospital management and staff;

(b) On-site observations of patients, staff performance, and the physical environment of the hospital facility;

(c) Review of documents and records; and

(d) Patient audits.

(5) A hospital shall make all requested documents and records available to the surveyor for review and copying.

(6) Following a survey Division staff may conduct an exit conference with the hospital administrator or his or her designee. During the exit conference Division staff shall:

(a) Inform the hospital representative of the preliminary findings of the inspection; and

(b) Give the person a reasonable opportunity to submit additional facts or other information to the surveyor in response to those findings.

(7) Following the survey, Division staff shall prepare and provide the hospital administrator or his or her designee specific and timely written notice of the findings.

(8) If the findings result in a referral to another regulatory agency, Division staff shall submit the applicable information to that referral agency for its review and determination of appropriate action.

(9) If no deficiencies are found during a survey, the Division shall issue written findings to the hospital administrator indicating that fact.

(10) If deficiencies are found, the Division shall take informal or formal enforcement action in compliance with OAR 333-501-0025 or 333-501-0030.

Stat. Auth.: ORS 441.025 & 441.062

Stats. Implemented: ORS 441.060 & 441.062

Hist.: PH 11-2009, f. & cert. ef. 10-1-09; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-501-0035

Nurse Staffing Audit Procedure

(1) The Division shall annually conduct random audits of not less than seven percent of all hospitals, to determine compliance with the requirements of ORS 441.162, 441.166 and 441.192.

(2) During an audit, the Division shall review:

(a) The hospital’s written hospital-wide staffing plan for nursing services to ensure that the staffing plan addresses all the requirements in OAR 333-510-0045(3);

(b) The job descriptions and personnel files of the nursing staff, which includes the documentation of required licensure and indicates the specialized qualifications and competencies of the nursing staff;

(c) The list of qualified, on-call nursing staff and staffing agencies the hospital contacts for replacement staff;

(d) The hospital’s process for obtaining replacement nursing staff, including efforts made to obtain replacement staff using all available resources;

(e) Documentation described in OAR 333-510-0045(2) and (4) through (7);

(f) The hospital’s process for evaluating and initiating limitation on admission or diversion of patients to another acute care facility;

(g) The hospital’s policy regarding mandatory overtime and the documentation of mandatory overtime pursuant to OAR 333-510-0045(9);

(h) The hospital’s policy regarding education and training to ensure that hospital-mandated hours are included in time worked;

(i) The hospital’s policy on maintenance, use and access to the on-call list for seeking replacement staff; and

(j) Documentation of the hospital’s efforts to seek replacement staff when needed.

(3) In conducting an audit, the Division may interview:

(a) Appropriate hospital staff regarding:

(A) Implementation and effectiveness of the nurse staffing plan for nursing services;

(B) Input, if any that was provided to the nurse staffing plan committee;

(C) Whether the hospital has a formal procedure for admission and diversion of patients to another acute care facility when, in the judgment of the direct care registered nurses, there is an inability to meet patient care needs or a risk of harm to existing and new patients; or

(D) Any other subject or fact relating to hospital nursing services that is subject to the review of the Division under this rule.

(b) Hospital staff that does not voluntarily come forward for an interview during an audit; and

(c) Patients or family members regarding concerns or complaints with regard to nurse staffing in the hospital.

(4) Following an audit, if the Division finds a provision of ORS 441.162 or 441.168 has been violated, the Division may issue either or both:

(a) A notice of violation requiring corrective action;

(b) A notice of civil penalty pursuant to ORS 441.170 and OAR 333-501-0045.

(5) A statement of deficiencies will be issued for all violations in addition to any civil penalty levied, in accordance with OAR 333-501-0035.

(6) The identity of witnesses providing evidence during an audit will be kept confidential to the extent permitted by state law. However, in the event witness testimony is needed in a hearing concerning a violation of a health care facility licensing law, the identity of a witness may be required to be disclosed.

Stat. Auth.: ORS 413.042 & 441.170

Stats. Implemented: ORS 441.160–441.192

Hist.: PH 11-2009, f. & cert. ef. 10-1-09; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-501-0040

Investigation Procedures for Investigation of Nurse Staffing Complaints

(1) As soon as possible after receiving a nurse staffing complaint, the Division shall interview the complainant and gather as much information as possible about the allegations.

(2) Following the review of the complaint and interview of the complainant, the Division will determine whether the allegations, if true, would constitute a violation of ORS 441.162 through 441.168. If the allegations constitute a violation of ORS 441.162 through 441.168, the Division will proceed with an on site complaint investigation.

(3) During an onsite complaint investigation, the Division may, as appropriate:

(a) Review any documentation described in OAR 333-501-0035(2) or any other documentation that may be relevant to the complaint, including a review of patient files;

(b) Interview any person described in OAR 333-501-0035(3) or any other person who may have information relevant to the type of complaint received; and

(c) Review any current waivers of the nurse staffing rules that the hospital has been granted.

(4) In conducting interviews during a complaint investigation under section (3) of this rule, the Division shall interview both direct care nurses and nurse managers and hospital staff that did not come forward voluntarily for an interview during an investigation, but who may have information relevant to the complaint.

(5) The Division shall determine whether the notice required under ORS 441.180 is posted in a conspicuous place on the premises of the hospital. The notice must be posted where notices to employees and applicants for employment are customarily displayed.

(6) In deciding whether there is a violation of ORS 441.162 through 441.168, the Division shall consider:

(a) Whether there is objective evidence discovered during the investigation to substantiate a complaint;

(b) The number of witnesses, and the credibility of the witnesses who will attest to an alleged violation of ORS 441.162 through 441.168; and

(c) Whether witness statements are corroborated or refuted by other evidence.

(7) Nothing in section (6) of this rule requires that witness statements be corroborated in order for the Division to find a violation of ORS 441.162 or 441.166.

(8) Following an investigation, if the Division finds a provision of ORS 441.162 or 441.168 has been violated, the Division may issue either or both:

(a) A notice of violation requiring corrective action;

(b) A notice of civil penalty pursuant to ORS 441.170 and OAR 333-501-0035.

(9) A statement of deficiencies will be issued for all violations in addition to any civil penalty levied.

(10) The identity of witnesses providing statements to the Division during an investigation will be kept confidential to the extent permitted by law. However, in the event witness testimony is needed in a hearing concerning a violation of ORS 441.162 through 441.168, the identity of a witness may be required to be disclosed.

(11) If during a complaint investigation, the Division has evidence that a hospital has engaged in a retaliatory act prohibited by ORS 441.174, the Division will advise the registered nurse, licensed practical nurse or certified nursing assistant to contact the Bureau of Labor and Industries regarding the concern.

Stat. Auth.: ORS 413.042 & 441.025

Stats. Implemented: ORS 441.160–441.192

Hist.: PH 11-2009, f. & cert. ef. 10-1-09; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-501-0045

Civil Penalties for Violations of Nurse Staffing Laws

(1) For the purposes of this rule, “safe patient care” has the meaning given the term in OAR 333-510-0002.

(2) The Division may impose civil penalties in the manner provided in ORS 441.170 for a violation of any provision of ORS 441.162 or 441.166 if there is reasonable belief that safe patient care has been or may be negatively impacted.

(3) Each violation of a nursing staff plan shall be considered a separate violation.

(4) Civil penalties may be imposed for violations of ORS 441.162 and 441.166 in accordance with Table 1 in this rule.

(5) The Division shall consider all evidence in determining a violation of the hospital nurse staffing rule including but not limited to witness testimony, written documents and observations.

(6) A civil penalty imposed under this rule shall comply with ORS 183.745.

(7) The Division shall maintain for public inspection records of any civil penalties imposed on hospitals penalized under this rule.

[ED. NOTE: Tables referenced are available from the agency.]

Stat. Auth.: ORS 413.042 & 441.170

Stats. Implemented: ORS 441.162, 441.166 & 441.170

Hist.: PH 11-2009, f. & cert. ef. 10-1-09; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-501-0055

Civil Penalties, Generally

(1) This rule does not apply to civil penalties for violations of ORS 441.162, 441.166, 441.815, or 435.254 or rules adopted to implement these statutes.

(2) A licensee that violates a health care facility licensing law, including OAR 333-501-0020 (violations), is subject to the imposition of a civil penalty not to exceed $500 per day per violation.

(3) In addition to the penalties under section (2) of this rule, civil penalties may be imposed for violations of ORS 441.030 or 441.015(1).

(4) In determining the amount of a civil penalty the Division shall consider whether:

(a) The Division made repeated attempts to obtain compliance;

(b) The licensee has a history of noncompliance with health care facility licensing laws;

(c) The violation poses a serious risk to the public’s health;

(d) The licensee gained financially from the noncompliance; and

(e) There are mitigating factors, such as a licensee’s cooperation with an investigation or actions to come into compliance.

(5) The Division shall document its consideration of the factors in section (4) of this rule.

(6) Each day a violation continues is an additional violation.

(7) A civil penalty imposed under this rule shall comply with ORS 183.745.

Stat. Auth.: ORS 441.025

Stats. Implemented: ORS 441.990

Hist.: PH 11-2009, f. & cert. ef. 10-1-09; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-501-0060

Approval of Accrediting Organizations

(1) An accrediting organization may request approval by the Division to ensure that hospitals meet state licensing standards.

(2) An accrediting organization shall request approval in writing and shall provide, at a minimum:

(a) Evidence that it is recognized as a deemed organization by CMS; or

(b) If the accrediting organization is not a deemed organization under CMS, provide:

(A) Documentation of program policies and procedures that its accreditation process meets state licensing standards;

(B) Accreditation history; and

(C) References from a minimum of two facilities currently receiving services from the organization.

(3) If the Division finds that an accrediting organization has the necessary qualifications to certify that state licensing standards have been met, the Division will enter into an agreement with the accrediting organization.

Stat. Auth.: ORS 441.062

Stats. Implemented: ORS 441.062

Hist.: PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-505-0005

Governing Body Responsibility

(1) The governing body of a hospital shall be responsible for the operation of the hospital, the selection of the medical staff and the quality of care rendered in the hospital. The governing body shall ensure that:

(a) All health care personnel for whom a state license or registration is required are currently licensed or registered;

(b) Qualified individuals allowed to practice in the hospital are credentialed and granted privileges consistent with their individual training, experience and other qualifications;

(c) Procedures for granting, restricting and terminating privileges exist and that such procedures are regularly reviewed to assure their conformity to applicable law;

(d) It has an organized medical staff responsible for reviewing the professional practices of the hospital for the purpose of reducing morbidity and mortality and for the improvement of patient care;

(e) A physician is not denied medical staff privileges at the facility solely on the basis that the physician holds medical staff membership or privileges at another health care facility;

(f) Licensed podiatric physicians and surgeons are permitted to use the hospital in accordance with ORS 441.063;

(g) All hospital employees and health care practitioners granted hospital privileges have been tested for tuberculosis in compliance with OAR 333-505-0080; and

(h) A notice, in a form specified by the division, summarizing the provisions of ORS 441.162, 441.166, 441.168, 441.174, 441.176, 441.178, 441.192 is posted in a place where notices to employees and applicants are customarily displayed.

(2) A hospital may grant privileges to nurse practitioners in accordance with ORS 441.064 and subject to hospital rules governing admissions and staff privileges. The hospital may refuse to grant privileges to nurse practitioners only upon the same basis that privileges are refused to other licensed health care practitioners.

(3) A hospital shall require that every patient admitted shall be and remain under the care of a member of the medical staff as specified under the medical staff by-laws.

Stat. Auth: ORS 441.025

Stats. Implemented: ORS 441.055

Hist.: HD 11-1980, f. & ef. 9-10-80; Renumbered from 333-023-0125; HD 29-1988, f. 12-29-88, cert. ef. 1-1-89, Renumbered from 333-070-0050; HD 21-1993, f. & cert. ef. 10-28-93, Renumbered from 333-505-0000; HD 2-2000, f. & cert. ef. 2-15-00; OHD 20-2002, f. & cert. ef. 12-10-02; PH 11-2009, f. & cert. ef. 10-1-09; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-505-0020

Medical Staff

(1) The medical staff is responsible for reviewing the professional practices of the hospital for the purpose of reducing morbidity and mortality and for the improvement of patient care, and is accountable to the governing body.

(2) The hospital’s medical staff organized pursuant to OAR 333-505-0005(1) shall include Medical Doctors and Doctors of Osteopathy, and may include other licensed health care practitioners as permitted by the governing body.

(3) The medical staff shall adopt and enforce by-laws, medical staff policies, and medical staff rules and regulations to carry out its responsibilities. The by-laws, medical staff policies, and medical staff rules and regulations must be approved by the governing body.

(4) By-laws, medical staff policies, and medical staff rules and regulations shall include but are not limited to:

(a) The organization of the medical staff, including qualifications for serving on the medical staff, nominations, election, appointment or removal of officers, and periodic review of its members;

(b) Criteria for credentialing health care practitioners and the process for applying for credentials;

(c) Criteria for restricting or terminating hospital privileges and the process for restricting or terminating hospital privileges;

(d) A process for periodically reviewing the procedures for granting, restricting, or terminating hospital privileges to ensure that procedures are being followed;

(e) Procedures for insuring that licensed health care practitioners with hospital privileges are acting within their scope of practice and acting consistent with the privileges granted;

(f) Procedures for the acceptance of verbal orders by those individuals authorized by law or their scope of practice to accept verbal orders;

(g) Criteria for tissue specimens and appliances that are subject to a macroscopic or microscopic pathology examination;

(h) Procedures for responding to medical emergencies, including contacting at least one physician in the event of a medical emergency; and

(i) Procedures for notifying patients orally and in writing of any financial interest as required by ORS 441.098.

(5) Amendments to medical staff by-laws shall be accomplished through a cooperative process involving both the medical staff and the governing body. Medical staff by-laws shall be adopted, repealed or amended when approved by the medical staff and the governing body. Approval shall not be unreasonably withheld by either. Neither the medical staff nor the governing body shall withhold approval if such appeal, amendment or adoption is mandated by law, statute or regulation or is necessary to obtain or maintain accreditation or to comply with fiduciary responsibilities or if the failure to approve would subvert the stated moral or ethical purposes of this institution.

(6) Physicians and all other health care practitioners with individual admitting privileges are subject to applicable provisions of the medical staff by-laws and rules governing admission and staff privileges.

Stat. Auth.: ORS 441.025

Stats. Implemented: ORS 441.055, 441.064 & 441.098

Hist.: HD 29-1988, f. 12-29-88, cert. ef. 1-1-89; HD 21-1993, f. & cert. ef. 10-28-93; HD 30-1994, f. & cert. ef. 12-13-94; PH 11-2009, f. & cert. ef. 10-1-09; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-505-0030

Organization, Hospital Policies

(1) A hospital’s internal organization shall be structured to include appropriate departments and services consistent with the needs of its defined community.

(2) A hospital shall adopt and maintain clearly written definitions of its organization, authority, responsibility and relationships.

(3) A hospital shall adopt, maintain and follow written patient care policies that include but are not limited to:

(a) Admission, transfer and discharge policies that address:

(A) Types of clinical conditions not acceptable for admission;

(B) Constraints imposed by limitations of services, physical facilities or staff coverage;

(C) Emergency admissions;

(D) Requirements for informed consent signed by the patient or legal representative of the patient for diagnostic and treatment procedures; such policies and procedures shall address informed consent of minors in accordance with provisions in ORS 109.610, 109.640, 109.670, and 109.675;

(E) Requirements for identifying persons responsible for obtaining informed consent and other appropriate disclosures and ensuring that the information provided is accurate and documented appropriately in accordance with these rules and ORS 441.098;

(F) A process for the internal transfer of patients from one level or type of care to another;

(G) Discharge and termination of services; and

(H) Planning for continuity of patient care following discharge.

(b) Patient rights;

(c) Housekeeping;

(d) All patient care services provided by the hospital; and

(e) Maintenance of the hospital’s physical plant, equipment used in patient care and patient environment.

(4) In addition to the policies described in section (3) of this rule, a hospital shall, in accordance with the Patient Self-Determination Act, 42 CFR ¦ 489.102, adopt policies and procedures that require (applicable to all capable individuals 18 years of age or older who are receiving health care in the hospital):

(a) Providing to each adult patient, including emancipated minors, not later than five days after an individual is admitted as an inpatient, but in any event before discharge, the following in written form, without recommendation:

(A) Information on the rights of the individual under Oregon law to make health care decisions, including the right to accept or refuse medical or surgical treatment and the right to execute directives and powers of attorney for health care;

(B) Information on the policies of the hospital with respect to the implementation of the rights of the individual under Oregon law to make health care decisions;

(C) A copy of the directive form set forth in ORS 127.531, along with a disclaimer attached to each form in at least 16-point bold type stating “You do not have to fill out and sign this form.”; and

(D) The name of a person who can provide additional information concerning the forms for directives.

(b) Documenting in a prominent place in the individual’s medical record whether the individual has executed a directive.

(c) Compliance with Oregon law relating to directives for health care.

(d) Educating the staff and the community on issues relating to directives.

(5) A hospital’s transfer agreements or contracts shall clearly delineate the responsibilities of parties involved.

(6) Patient care policies shall be evaluated triennially and rewritten as needed, and presented to the governing body or a designated administrative body for approval triennially. Documentation of the evaluation is required.

(7) A hospital shall have a system, described in writing, for the periodic evaluation of programs and services, including contracted services.

Stat. Auth.: ORS 441.025

Stats. Implemented: ORS 441.025

Hist.: HD 29-1988, f. 12-29-88, cert. ef. 1-1-89; PH 11-2009, f. & cert. ef. 10-1-09; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-505-0033

Patient Rights

A hospital shall comply with the requirements for patients rights set out in 42 CFR ¦ 482.13.

Stat. Auth.: ORS 441.025

Stats. Implemented: ORS 441.025

Hist.: PH 11-2009, f. & cert. ef. 10-1-09; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-505-0050

Medical Records

(1) A medical record shall be maintained for every patient admitted for care in a hospital.

(2) A legible reproducible medical record shall include, but is not limited to (as applicable):

(a) Admitting identification data including date of admission.

(b) Chief complaint.

(c) Pertinent family and personal history.

(d) Medical history, physical examination report and provisional diagnosis as required by OAR 333-510-0010.

(e) Admission notes outlining information crucial to patient care.

(f) All patient admission, treatment, and discharge orders.

(A) All patient orders shall be initiated, dated, timed and authenticated by a licensed health care practitioner in accordance with section (7) of this rule.

(B) Documentation of verbal orders shall include:

(i) The date and time the order was received;

(ii) The name and title of the health care practitioner who gave the order; and

(iii) Authentication by the authorized individual who accepted the order, including the individual’s title.

(C) Verbal orders shall be dated, timed, and authenticated within 48 hours by the ordering health care practitioner or another health care practitioner who is responsible for the care of the patient.

(D) For purposes of this rule, a verbal order includes but is not limited to an order given over the telephone.

(g) Clinical laboratory reports as well as reports on any special examinations. (The original report shall be recorded in the patient’s medical record.)

(h) X-ray reports bearing the identification of the originator of the interpretation.

(i) Consultation reports when such services have been obtained.

(j) Records of assessment and intervention, including graphic charts and medication records and appropriate personnel notes.

(k) Discharge summary including final diagnosis.

(l) Discharge order.

(m) Autopsy report if applicable.

(n) Such signed documents as may be required by law.

(o) Informed consent forms that document:

(A) The name of the hospital where the procedure or treatment was undertaken;

(B) The specific procedure or treatment for which consent was given;

(C) The name of the health care practitioner performing the procedure or administering the treatment;

(D) That the procedure or treatment, including the anticipated benefits, material risks, and alternatives was explained to the patient or the patient’s representative or why it would have been materially detrimental to the patient to do so, giving due consideration to the appropriate standards of practice of reasonable health care practitioners in the same or a similar community under the same or similar circumstances;

(E) The manner in which care will be provided in the event that complications occur that require health services beyond what the hospital has the capability to provide;

(F) The signature of the patient or the patient’s legal representative; and

(G) The date and time the informed consent was signed by the patient or the patient’s legal representative.

(p) Documentation of the disclosures required in ORS 441.098.

(3) A medical record of a surgical patient shall include, in addition to other record requirements, but is not limited to:

(a) Preoperative history, physical examination and diagnosis documented prior to operation.

(b) Anesthesia record including preanesthesia assessment and plan for anesthesia, records of anesthesia, analgesia and medications given in the course of the operation and postanesthetic condition.

(c) A record of operation dictated or written immediately following surgery and including a complete description of the operation procedures and findings, postoperative diagnostic impression, and a description of the tissues and appliances, if any, removed. When the dictated operative report is not placed in the medical record immediately after surgery, an operative progress note shall be entered in the medical record after surgery to provide pertinent information for any individual required to provide care to the patient.

(d) Postanesthesia recovery progress notes.

(e) Pathology report on tissues and appliances, if any, removed at the operation.

(4) An obstetrical record for a patient, in addition to the requirements for medical records, shall include but is not limited to:

(a) The prenatal care record containing at least a serologic test result for syphilis, Rh factor determination, and past obstetrical history and physical examination.

(b) The labor and delivery record, including reasons for induction and operative procedures, if any.

(c) Records of anesthesia, analgesia, and medications given in the course of delivery.

(5) A medical record of a newborn or stillborn infant, in addition to the requirement for medical records, shall include but is not limited to:

(a) Date and hour of birth; birth weight and length; period of gestation; sex; and condition of infant on delivery (Apgar rating is recommended).

(b) Mother’s name and hospital number.

(c) Record of ophthalmic prophylaxis or refusal of same.

(d) Physical examination at birth and at discharge.

(e) Progress and nurse’s notes including temperature; weight and feeding data; number, consistency and color of stools; urinary output; condition of eyes and umbilical cord; condition and color of skin; and motor behavior.

(f) Type of identification placed on infant in delivery room;

(g) Newborn hearing screening tests in accordance with OAR 333-020-0130.

(6) A patient’s emergency room, outpatient and clinic records, in addition to the requirements for medical records, shall be maintained and available to the other professional services of the hospital and shall include but are not limited to:

(a) Patient identification.

(b) Admitting diagnosis, chief complaint and brief history of the disease or injury.

(c) Physical findings.

(d) Laboratory and X-ray reports (if performed), as well as reports on any special examinations. The original report shall be authenticated and recorded in the patient’s medical record.

(e) Diagnosis.

(f) Record of treatment, including medications.

(g) Disposition of case with instructions to the patient.

(h) Signature or authentication of attending physician.

(i) A record of the pre-hospital report form (when patient is brought in by ambulance) shall be attached to the emergency room record.

(7) All entries in a patient’s medical record shall be dated, timed and authenticated.

(a) Authentication of an entry requires the use of a unique identifier, including but not limited to a written signature or initials, code, password, or by other computer or electronic means that allows identification of the individual responsible for the entry.

(b) Systems for authentication of dictated, computer, or electronically generated documents must ensure that the author of the entry has verified the accuracy of the document after it has been transcribed or generated.

(8) The following records shall be maintained and kept permanently in written or computerized form:

(a) Patient’s register, containing admissions and discharges;

(b) Patient’s master index;

(c) Register of all deliveries, including live births and stillbirths;

(d) Register of all deaths;

(e) Register of operations;

(f) Register of outpatients (seven years);

(g) Emergency room register (seven years); and

(h) Blood banking register (20 years).

(9) The completion of the medical record shall be the responsibility of the attending qualified member of the medical staff. Any licensed health care practitioner responsible for providing or evaluating the service provided shall complete and authenticate those portions of the record that pertain to their portion of the patient’s care. The appropriate individual shall authenticate the history and physical examination, operative report, progress notes, orders and the summary. In a hospital using interns, such orders must be according to policies and protocols established and approved by the medical staff. An authentication of a licensed health care practitioner on the face sheet of the medical record does not suffice to cover the entire content of the record:

(a) Medical records shall be completed by a licensed health care practitioner and closed within four weeks following the patient’s discharge.

(b) If a patient is transferred to another health care facility, transfer information shall accompany the patient. Transfer information shall include but is not limited to:

(A) The name of the hospital from which they were transferred;

(B) The name of physician or other health care practitioner to assume care at the receiving facility;

(C) The date and time of discharge;

(D) The current medical findings;

(E) The current nursing assessment;

(F) Current medical history and physical information;

(G) Current diagnosis;

(H) Orders from a physician or other licensed health care practitioner for immediate care of the patient;

(I) Operative report, if applicable;

(J) TB test, if applicable; and

(K) Other information germane to patient’s condition.

(c) If the discharge summary is not available at time of transfer, it shall be transmitted to the new facility as soon as it is available.

(10) Diagnoses and operations shall be expressed in standard terminology. Only abbreviations approved by the medical staff may be used in the medical records.

(11) Medical records shall be filed and indexed. Filing shall consist of an alphabetical master file with a number cross-file. Indexing is to be done according to diagnosis, operation, and qualified member of the medical staff, using a system such as the International or Standard nomenclature systems.

(12) Medical records are the property of the hospital. The medical record, either in original, electronic or microfilm form, shall not be removed from the hospital except where necessary for a judicial or administrative proceeding. Treating and attending physicians shall have access to medical records. When a hospital uses off-site storage for medical records, arrangements must be made for delivery of these records to the hospital when needed for patient care or other hospital activities. Precautions must be taken to protect patient confidentiality.

(13) Authorized personnel of the Division shall be permitted to review medical records and patient registers as necessary to determine compliance with health care facility licensing laws.

(14) Medical records shall be kept for a period of at least 10 years after the date of last discharge. Original medical records may be retained on paper, microfilm, electronic or other media.

(15) Medical records shall be protected against unauthorized access, fire, water and theft.

(16) If a hospital changes ownership, all medical records in original, electronic or microfilm form shall remain in the hospital and it shall be the responsibility of the new owner to protect and maintain these records.

(17) If a hospital closes, its medical records and the registers required under section (8) of this rule may be delivered and turned over to any other hospital in the vicinity willing to accept and retain the same as provided in section (12) of this rule. A hospital which closes permanently shall follow the procedure for Division and public notice regarding disposal of medical records under OAR 333-500-0060.

(18) All original clinical records or photographic or electronic facsimile thereof, not otherwise incorporated in the medical record, such as X-rays, electrocardiograms, electroencephalograms, and radiological isotope scans shall be retained for seven years after a patient’s last discharge if professional interpretations of such graphics are included in the medical records.

(19) If a qualified medical record practitioner, RHIT (Registered Health Information Technician) or RHIA (Registered Health Information Administrator) is not the Director of the Medical Records Department, periodic and at least annual consultation must be provided by a qualified medical records consultant, RHIT/RHIA. The visits of the medical records consultant shall be of sufficient duration and frequency to review medical record systems and assure quality records of the patients. The contract for such services shall be made available to the Division.

(20) A current written policy on the release of medical record information including a patient’s access to his or her medical record shall be maintained in the medical records department.

(21) A hospital is not required to keep a medical record in accordance with this rule for a person referred to a hospital ancillary department for a diagnostic procedure or health screening by a private physician, dentist, or other licensed health care practitioner acting within his or her scope of practice.

(22) Pursuant to ORS 441.059, the rules of a hospital that govern patient access to previously performed X-rays or diagnostic laboratory reports shall not discriminate between patients of chiropractic physicians and patients of other licensed health care practitioners permitted access to such X-rays and diagnostic laboratory reports.

(23) Nothing in this rule is meant to prohibit or discourage a hospital from maintaining its records in electronic form.

Stat. Auth: ORS 441.025

Stats. Implemented: ORS 441.025

Hist.: HB 183, f. & ef. 5-26-66; HB 235, f. 2-5-70, ef. 2-25-70; HB 253, f. 7-22-70, ef. 8-25-70; HB 255, f. 9-15-70, ef. 10-11-70; HD 11-1980, f. & ef. 9-10-80; HD 8-1984, f. & ef. 5-7-84; Renumbered from 333-023-0190; HD 29-1988, f. 12-29-88, cert. ef. 1-1-89, Renumbered from 333-070-0055; HD 21-1993, f. & cert. ef. 10-28-93; 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 26-2010, f. 12-14-10, cert. ef. 12-15-10

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, 2010.

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