Public Health_333

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The Oregon Administrative Rules contain OARs filed through January 15, 2010

DEPARTMENT OF HUMAN SERVICES, PUBLIC HEALTH DIVISION

DIVISION 76

SPECIAL HEALTH CARE FACILITIES

Ambulatory Surgical Centers ASC

333-076-0101

Definitions

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

(1) "Health Care Facility" (HCF) has the meaning given the term in ORS 442.015, and includes but is not limited to the following classifications:

(a) "Hospital" means an establishment with an organized medical staff with facilities that include inpatient beds, and with medical services, including physician services and continuous nursing services under the supervision of registered nurses, to provide diagnosis and medical or surgical treatment primarily for, but not limited to, acutely ill patients and accident victims, or to provide treatment for the mentally ill or to provide treatment in special inpatient care facilities. "Special Inpatient Care Facilities" are facilities with inpatient beds and other facilities designed and utilized for special health care purposes, to include but not be limited to: rehabilitation center, college infirmary, chiropractic facility, facility for the treatment of alcoholism or drug abuse, or inpatient care 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;

(b) "Long Term Care Facility" (LTCF) means an establishment with permanent facilities that include inpatient beds, providing medical services, including nursing services but excluding surgical procedures except as may be permitted by the rules of the Director of the Department of Human Services, to provide treatment for two or more unrelated patients. "Long term care facility" includes the terms "skilled nursing facility" and "intermediate care facility" but such definition shall not be construed to include facilities licensed and operated pursuant to ORS 443.400-443.455; and

(c) "Ambulatory Surgical Center" (ASC) means a health care facility which performs outpatient surgery not routinely or customarily performed in a physician's or dentist's office, and is able to meet health facility licensure requirements:

(A) In the case of outpatient surgery involving termination of pregnancy, procedures routinely and customarily done in physician's offices are the following:

(i) Dilation and curettage;

(ii) Suction curettage;

(iii) Sharp curettage; and

(iv) Dilation and evacuation.

(B) A freestanding birthing center means a health care facility licensed for the primary purpose of performing low risk deliveries.

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

(3) "Certified Nursing Assistant" (CNA) means a person who is certified by an Oregon State Board of Nursing approved training program to assist licensed nursing personnel in the provision of nursing care.

(4) "Certified Nurse Anesthetist" (CRNA) means a registered nurse certified by the American Association of Nurse Anesthetists.

(5) "Certified Nurse Midwife" (CNMW) means a registered nurse certified by the Oregon State Board of Nursing as a nurse practitioner midwife.

(6) "Chiropractor" means a person licensed under ORS Chapter 684 to practice chiropractic.

(7) "Division" means the Public Health Division of the Oregon Department of Human Services.

(8) "Governing Body" means the body or person legally responsible for the direction and control of the operation of the facility.

(9) "Governmental Unit" means the state, or any county, municipality, or other political subdivision, or any related department, division, board or other agency.

(10) "Health Care Facility Licensing Law" means ORS 441.015-441.990 and rules thereunder.

(11) "Inpatient Beds" means a bed in a facility available for occupancy by a patient who will or may be cared for and treated on an overnight basis.

(12) "Institutional Health Services" means health services provided in or through health care facilities and includes the entities in or through which such services are provided.

(13) "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.

(14) "Licensed Nurse" means a Registered Nurse (RN) or a Licensed Practical Nurse (LPN).

(15) "Licensed Practical Nurse" (LPN) means a person licensed under ORS Chapter 678 to practice practical nursing.

(16) "Major Alteration" means changes other than repair or replacement of building materials and equipment with materials and equipment of a similar type.

(17) "Naturopath" means a person licensed under ORS Chapter 685 to practice naturopathy.

(18) "New Construction" means a new building or an addition to an existing building.

(19) "NFPA" means National Fire Protection Association.

(20) "Nurse Practitioner" means a registered nurse who has been certified by the Board of Nursing as qualified to practice in an expanded specialty role within the practice of nursing.

(21) "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.

(22) "Oregon Sanitary Code" means the Food Sanitation Rules, OAR 333-150-0000.

(23) "Patient Audit" means review of the medical record and/or physical inspection of a patient.

(24) "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).

(25) "Physician" means a person licensed under ORS Chapter 677 to practice medicine by the Board of Medical Examiners.

(26) "Physician's Assistant" means a person who is registered as a physician's assistant in accordance with ORS Chapter 677.

(27) "Podiatrist" means a person licensed under ORS Chapter 677 to practice podiatry.

(28) "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 Board of Medical Examiners for the State of Oregon. "Podiatry" does not include the administration of general or spinal anesthetics or the amputation of the foot.

(29) "Registered Nurse" (RN) means a person licensed as a Registered Nurse under ORS Chapter 678.

Stat. Auth.: ORS 441.030, 441.057, 441.160-441.192
Stats. Implemented: ORS 441.030, 441.057, 441.160, 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

333-076-0106

Issuance of License

(1) Application for a license to operate a health care facility 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) No person or health care facility 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.

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

(4) No license shall be issued or renewed for any Health Care Facility (HCF) that offers or proposes to develop a new health service, unless a certificate of need has first been issued under Sections (2) or (9) of Chapter 1034, Oregon Laws, 1989.

(5) 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 & ORS 442
Stats. Implemented: ORS 441 & ORS 442
Hist.: HD 3-1990, f. 1-8-90, cert. ef. 1-15-90

333-076-0108

Expiration and Renewal of License

Each license to operate a health care facility 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 & ORS 442
Stats. Implemented: ORS 441 & ORS 442
Hist.: HD 3-1990, f. 1-8-90, cert. ef. 1-15-90

333-076-0109

Denial or Revocation of a License

(1) A license for any health care facility 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 a health care facility 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 a health care facility's substantial lack of compliance with the rules or statutes.

Stat. Auth.: ORS 441 & ORS 442
Stats. Implemented: ORS 441 & ORS 442
Hist.: HD 3-1990, f. 1-8-90, cert. ef. 1-15-90

333-076-0110

Return of Facility License

Each license certificate in the licensee's possession shall be returned to the Division immediately on the suspension or revocation of the license, failure to renew the license by December 31, or if operation is discontinued by the voluntary action of the licensee.

Stat. Auth.: ORS 441 & ORS 442
Stats. Implemented: ORS 441 & ORS 442
Hist.: HD 3-1990, f. 1-8-90, cert. ef. 1-15-90

333-076-0111

Classification

(1) The various types of health care facilities within the provisions of ORS Chapter 441 are classified as follows:

(a) Hospital Classifications:

(A) General Hospital;

(B) Mental Hospital or Psychiatric Hospital;

(D) Special Inpatient Care Facility Classifications:

(i) Chiropractic Facility;

(ii) Facility for the Treatment of Alcoholism and/or Substance Abuse;

(iii) Infirmary: College Infirmary or Student Health Center;

(iv) Rehabilitation Center;

(v) Christian Science Facility;

(vi) Infirmary for the Homeless;

(vii) Freestanding Hospice Facility.

(b) Ambulatory Surgical Center;

(2) The classification of each health care facility shall be so designated on the license.

(3) Health care facilities 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. General Hospitals may be described as hospitals without modifications by the term "general".

(4) No change in the licensed classification of any health care facility, 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 & ORS 442
Stats. Implemented: ORS 441 & ORS 442
Hist.: HD 3-1990, f. 1-8-90, cert. ef. 1-15-90

333-076-0112

Hearings

Upon written notification by the Division of revocation, suspension or denial to issue or renew a license, a written request by the facility for a hearing in accordance with ORS 183.310 to 183.500 shall be granted by the Division.

Stat. Auth.: ORS 441 & ORS 442
Stats. Implemented: ORS 441 & ORS 442
Hist.: HD 3-1990, f. 1-8-90, cert. ef. 1-15-90

333-076-0113

Adoption by Reference

All rules, standards and publications referred to in Oregon Administrative Rules, Division 76 are made a part thereof. Copies are available for inspection in the Division during office hours. Where publications are in conflict with the rules, the rules shall govern.

Stat. Auth.: ORS 441 & ORS 442
Stats. Implemented: ORS 441 & ORS 442
Hist.: HD 3-1990, f. 1-8-90, cert. ef. 1-15-90

333-076-0114

Division Procedures

Inspections and investigations:

(1) Complaints:

(a) Any person may make a complaint to the Health 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 HCF management and staff; observations of the patient(s), staff performance, patient environment and physical environment; and review of documents and records;

(b) Copies of all complaint investigations, will be available from the Division provided that the identity of any patient referred to in an investigation will not be disclosed without legal authorization.

(2) Inspections:

(a) The Division may, in addition to any inspections conducted pursuant to complaint investigations, conduct at least one general inspection of each HCF to determine compliance with HCF laws during each calendar year and at such other times as the Division deems necessary. The Division may accept certificates by the Joint Commission on Accreditation of Health Care Organizations (JCAHO) or the Committee on Hospitals of the American Osteopathic Association as evidence of compliance with acceptable standards in lieu of health care facility inspections;

(b) Facilities providing Joint Commission on Accreditation of Health Care Organizations (JCAHO) or Committee on Hospitals of the American Osteopathic Association (CHAOA) 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 JCAHO (or CHAOA, as appropriate) survey and inspection reports; and

(B) Written evidence of all corrective actions underway, or completed, in response to JCAHO (or CHAOA, as appropriate) recommendations; including all progress reports.

(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 HCF shall make the requested materials available to the investigator for review and copying.

Stat. Auth.: ORS 441 & ORS 442
Stats. Implemented: ORS 441 & ORS 442
Hist.: HD 3-1990, f. 1-8-90, cert. ef. 1-15-90

333-076-0115

Governing Body Responsibility

The governing body of each health care facility 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; and

(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.

Stat. Auth.: ORS 441 & ORS 442
Stats. Implemented: ORS 441 & ORS 442
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)

333-076-0120

Medical Staff

(1) The physicians organized into a medical staff pursuant to OAR 333-076-0115 shall propose medical staff bylaws to govern the medical staff. The bylaws shall include, but not be limited to the following:

(a) Procedures for physicians admitted to practice in the facility to organize into a medical staff;

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

(c) Provisions establishing a framework for the medical staff to nominate, elect, appoint or remove officers and other persons to carry out medical staff activities with accountability to the governing body;

(d) Procedures for insuring that physicians admitted to practice in the facility are currently licensed by the Board of Medical Examiners for the State of Oregon;

(e) Procedures for insuring that the facility's procedures for granting, restricting and terminating privileges are followed and that such procedures are regularly reviewed to assure their conformity to applicable law; and

(f) Procedures for insuring that physicians provide services within the scope of the privileges granted by the governing body.

(2) Amendments to medical staff bylaws shall be accomplished through a cooperative process involving both the medical staff and the governing body. Medical staff bylaws 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 repeal, 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.

Stat. Auth.: ORS 441 & ORS 442
Stats. Implemented: ORS 441 & ORS 442
Hist.: HD 3-1990, f. 1-8-90, cert. ef. 1-15-90

333-076-0125

Personnel

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

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

(3) Provisions shall be made for orientation.

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

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

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

(7) There shall be an employee health program for the protection of patients:

(a) Pursuant to OAR 333-019-0010:

(A) To protect the public health, a person who works in an ambulatory surgery center may not attend or work at the center while in a communicable stage of any restrictable diseases unless authorized in accordance with section (7)(b) of this rule.

(B) At an ambulatory surgery center, restrictable diseases include: diphtheria, measles, Salmonella Typhi infection, shigellosis, Shiga-toxigenic Escherichia coli (STEC) infection, hepatitis A, tuberculosis, open or draining skin lesions infected with Staphylococcus aureus or Streptococcus pyogenes and any illness accompanied by diarrhea or vomiting.

(b) The infection control committee of the health care facility shall adopt policies to restrict the working of employees with health care facility restrictable diseases. When measures have been taken to prevent the transmission of disease and these measures are in accordance with written procedures approved by the infection control committee of the facility after consultation with the local health officer, infectious employees may work in a health care facility. Nothing in these rules prohibits health care facilities and local health departments from adopting additional or more stringent rules for exclusion from these facilities.

(A) Each ambulatory surgery center shall formally assess the risk of tuberculosis transmission among staff following the recommendations outlined in "Guidelines for preventing the transmission of Mycobacterium tuberculosis in Health-Care Facilities," published by the Centers for Disease Control and Prevention (Morbidity and Mortality Weekly Report, vol. 43, number RR-13, October 28, 1994) or by following recommendations otherwise approved by the Division.

(B) All personnel working in an ambulatory surgery center shall within 30 days prior to or following employment have an examination, as provided in OAR 333-026-0015, to determine whether an employee has transmissible tuberculosis.

(C) An employee whose employment never requires him/her to be in a room where patients or residents might enter, and who does not handle clinical specimens or other material from patients or their rooms, may be exempted from the requirements of section (7)(c)(B) of this rule. An example of such an employee would be an administrative person or research worker whose place of work is remote from patient or residential care areas and who does not come in contact with clinical specimens.

(D) In the event that a case of communicable tuberculosis is diagnosed in an employee or patient of a health care facility, the facility shall conduct an investigation to identify contacts. The local health department shall assist in the investigation.

(E) The actions taken under sections (7)(c)(A)-(D) of 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.]

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 which may be performed in the facility;

(b) Types of anesthesia which 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;

(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; and

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

Stat. Auth.: ORS 441.030, 441.057, 441.160-441.192
Stats. Implemented: ORS 441.030, 441.057, 441.160, 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

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 Type I 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 441.030, 441.057, 441.160-441.192
Stats. Implemented: ORS 441.030, 441.057, 441.160, 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

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 56A, Standards for Use of Inhalation Anesthetics, unless the governing body's written policy forbids the use or storage of flammable anesthetics in the facility.

[Publications: The publication(s) referred to or incorporated by reference in this rule are available from the agency.]

333-076-0145

Storage, Disposal and Dispensing of Drugs

(1) In an ASF 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 ASF 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;

(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 State 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 health care facility are subject to ORS Chapter 689 and the rules thereunder.

333-076-0150

Emergency Services

The facility shall provide services, equipment and staff necessary to implement emergency medical care protocols.

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. See 333-076-0165.

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

333-076-0160

Care of Patients

(1) 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.

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

(3) At the time of discharge from the ASF, each patient must be evaluated by a physician for proper anesthesia recovery.

(4) 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.

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

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

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;

(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)(A) All entries in patient's medical record must be dated, timed, and authenticated. 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 by the prescriber;

(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 every, 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) 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 ten 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 hospital 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 Health Division may require the facility to obtain periodic and at least annual consultation from a qualified medical records consultant, RRA/ART. 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 & ORS 442
Stats. Implemented: ORS 441 & ORS 442
Hist.: HD 3-1990, f. 1-8-90, cert. ef. 1-15-90

333-076-0170

Quality Assurance

The governing body of a health care facility must ensure that there is an effective, written, facility-wide quality assurance program to evaluate and monitor the quality and appropriateness of patient care, including contracted services. Written documentation of quality assurance activities shall be recorded at least quarterly.

Stat. Auth.: ORS 441 & ORS 442
Stats. Implemented: ORS 441 & ORS 442
Hist.: HD 3-1990, f. 1-8-90, cert. ef. 1-15-90

333-076-0175

Infection Control

(1) Each Health Care Facility shall establish an active facility-wide infection control program. The program shall be under the direction of a multi-disciplinary committee which shall be responsible for investigating, controlling and preventing infections in the facility. Each Health Care Facility 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 and employees;

(b) Control of factors affecting the transmission of infections;

(c) Provisions for orienting and educating all employees and volunteers on the cause, transmission, and prevention of infections;

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

(2) Each Health Care Facility shall be responsible for the implementation of policies under section (1) of this rule.

(3) All Health Care Facilities shall maintain compliance with the rules of the Division for the control of communicable diseases.

(4) Written isolation procedures in accordance with current Center for Communicable Disease Control Guidelines for universal precautions shall be established and followed by all Health Care Facility personnel for control and prevention of cross-infection. Guidelines can be obtained from U.S. Department of Health and Human Services, Public Health Center for Disease Control, Atlanta, GA 30333. Any guidelines published and distributed by the Division shall also be taken into consideration.

Stat. Auth.: ORS 441 & ORS 442
Stats. Implemented: ORS 441 & ORS 442
Hist.: HD 3-1990, f. 1-8-90, cert. ef. 1-15-90

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;

(d) Other special needs of the facility 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 and names of attendees.

Stat. Auth.: ORS 441 & ORS 442
Stats. Implemented: ORS 441 & ORS 442
Hist.: HD 3-1990, f. 1-8-90, cert. ef. 1-15-90

333-076-0185

Physical Environment

(1) Facility Types: Facility Types for purposes of construction standards are as follows:

(a) Type I centers perform invasive procedures involving higher relative infection control considerations including but not limited to cholesystectomy, tonsillectomy, urologic procedures and D & C or provide general anesthesia;

(b) Type II centers are limited to procedures involving less infection risk, including but not limited to eyes, extremities, epidermis or diagnostic workups with local anesthesia or conscious sedation.

(2) Location: The outpatient surgical facility shall be arranged to preclude movement of unrelated traffic through the operating room suite and recovery area.

(3) Mixed facilities: When the ASC is connected to or a part of another facility, support facilities such as waiting areas, public toilets and exam rooms may be shared insofar as practical, but must conform to rules of the Division.

(4) Conformance to Building and Fire and Life Safety Codes: Facilities shall conform to the editions of the Oregon State Building Code, as defined in ORS 455.010(8), under which they were constructed. Newly licensed facilities and those to be certified for Medicare reimbursement shall meet standards of the National Fire Protection Association (NFPA) #101 and #99 Codes.

(5) Administrative and Public Areas: The following shall be provided:

(a) A waiting room or area and information and reception desk or counter;

(b) Access to public toilet facilities;

(d) Space(s) for private interviews relating to social services, credit and admission;

(e) Office space(s) for business transactions, records and administrative and professional staff;

(f) Space and facilities for medical records dictating, recording, storage and retrieval;

(g) Secure storage for staff clothing and personal effects;

(h) General storage for administrative supplies.

(6) Sterilizing Facilities: A sterilizing facility which shall contain an autoclave(s) large enough to sterilize all necessary instruments and materials for the day's entire schedule. Where only disposable supplies, instruments and equipment are used, this section will not apply.

(7) Operating and Recovery Facilities:

(a) At least one room usable for examination and testing of patients prior to surgery;

(b) One or more operating rooms shall be provided in Type I facilities, the minimum room size, exclusive of cabinets and shelves, shall be 250 sq. ft. with a minimum dimension of 14 feet. In Type II facilities, the minimum size shall be 200 sq. ft. with a minimum dimension of 12 feet. At least one film illuminator shall be provided, except where the procedures performed do not require use of x-rays. An emergency communication system connected with the surgical control station shall be provided in all operating rooms;

(c) Room(s) for recovery of outpatients shall be provided in Type I facilities and in Type II facilities when procedures require postanesthesia recovery. At least three feet shall be provided at each side of each bed or recovery lounge chair and at the foot of each bed as needed for circulation;

(d) Separately dedicated recovery spaces or a dedicated recovery lounge shall be provided in facilities when the surgical program includes patients who do not require postanesthesia recovery, but need additional time for observation by staff prior to leaving the facility.

(8) Support Facilities: The following shall be provided when applicable to the service types offered:

(a) A control station, located to permit surveillance of all traffic entering each operating suite;

(b) A drug distribution station, with sink, for storage and preparation of medications;

(d) Soiled workroom, which shall contain a clinical sink or equivalent flushing type fixture, work counter, sink for handwashing and waste receptacle(s). The clinical sink may be eliminated when the surgical program does not require disposal of liquid or solid wastes;

(e) A separate clean workroom or a clean supply room. A clean workroom is required when clean materials are assembled within the facility prior to use; it shall contain a work counter, sink equipped for handwashing, and space for clean and sterile supplies. A clean supply room may be provided when the narrative program defines a system for the storage and distribution of clean and sterile supplies that does not require the assembling of materials;

(f) Anesthesia storage facilities shall be provided in Type I facilities and Type II facilities when the program includes anesthesia use;

(g) Medical gas supply and storage shall be provided in all facilities where central oxygen or nitrous oxide systems are installed and shall meet requirements of Article 74, Division 2 of the Oregon Fire Code, and National Fire Protection Association 99, Chapter 4.

(h) Equipment storage room or space for all equipment and supplies used in the surgical suite;

(i) In Type I facilities, staff clothes change areas shall be provided for staff working within the surgical suite and shall be arranged to provide one-way traffic so that personnel entering from outside can change and move directly into the surgical suite. In Type II facilities, staff clothes change areas shall be provided, but a one-way traffic flow is not required. Staff toilet facilities shall be provided convenient to clothes change areas;

(j) Outpatient surgery change areas shall be provided where outpatients can change from street clothing to hospital gowns and be prepared for surgery;

(k) Toilet facilities shall be provided for patients;

(l) Janitors' closet. Space containing a floor receptor or service sink and storage space for housekeeping supplies and equipment shall be provided exclusively for surgical areas. Cleaning preparations shall be accurately labeled and safely stored;

(m) In new facilities, storage of at least one wheelchair convenient to waiting area and entry;

(n) Provisions for convenient access to and use of emergency equipment at both surgical and recovery areas;

(o) Telephone communication to summon help in case of fire or other emergency shall be available.

(9) Details and Finishes:

(a) In new construction, the minimum public corridor width shall be five feet in width and minimum staff corridor four feet in width;

(b) In new construction, the minimum door width for patient use shall be 2 feet 10 inches, except where patients will be transported in a bed or gurney; these doors shall be a minimum 3 feet 8 inches in width;

(c) In new construction, handwash sinks shall be equipped with wristblade handles, single lever mixing valve, knee control or other devices which allow operation without use of the hands;

(d) Provisions for hand drying shall be included at all handwashing facilities except scrub sinks;

(e) If x-ray or gamma ray installations are included, they shall be licensed and approved by the Health Division, Radiation Control Section, prior to use;

(f) In new construction, ceiling heights shall be a minimum of 7 feet 10 inches except when overhead exam lights or other equipment require a higher ceiling;

(g) Floor materials shall be readily cleanable and appropriately wear-resistant. In all areas subject to wet cleaning, floor materials shall not be physically affected by liquid germicidal and cleaning solutions. Floors subject to traffic while wet, including showers and bath areas, shall have a nonslip surface;

(h) Wall finishes in clinically related areas shall be washable, and shall be smooth and moisture resistant in operating rooms and in close proximity to plumbing fixtures;

(i) In new construction, wall bases in areas subject to frequent wet cleaning methods and in operating rooms shall be monolithic, coved with the floor, and constructed without voids.

(10) Elevators: In new construction, elevators serving operating and recovery areas on floor without a horizontal exit to grade, shall be sized to accept a gurney or stretcher plus an attendant.

(11) Mechanical Standards: The following requirements apply:

(a) In new construction, the mechanical system shall be designed and constructed for overall efficiency in accord with the Oregon Mechanical Specialty Code and Chapter 53 of the Oregon Structural Specialty Code, as enforced by the Oregon Building Codes Division or local jurisdictions having authority;

(b) Facility design may include consideration of recognized procedures such as variable-air-volume systems, load shedding, programmed controls for unoccupied periods (nights and weekends, etc.), and use of natural ventilation, site and climatic conditions permitting;

(c) Prior to acceptance of a new or remodeled facility all mechanical systems shall be tested, balanced, and operated to demonstrate to the design engineer and the Division that the installation and performance of these systems conform to design intent. Test results shall be documented for maintenance filed;

(d) In new construction, duct linings shall not be installed in new systems serving operating and recovery rooms unless they are Mylar or Teflon lined and meet the Erosion Test Method described in Underwriters Laboratory Publication No. 181;

(e) In new construction, fans serving exhaust systems shall be located at the discharge end and be located for service access;

(f) In new construction, fresh air intakes shall be located at least 25 feet from exhaust outlets of ventilating systems, combustion equipment stacks, medical-surgical vacuum systems, plumbing vents, or areas that may collect vehicular exhaust or other noxious fumes;

(g) New ventilation system installations shall be designed and balance at project completion to provide directional flow as shown in Table 1. A log shall be prepared showing actual ventilation rates at each supply, return and exhaust grill, and be made available to the facility and inspecting agencies on request;

(h) In new construction, operating room supply shall be from ceiling outlets near the center of the work area for effective air movement control. Return air shall be from near the floor level. Each operating room shall have at least two return inlets located as remotely from each other as practical;

(i) Each space routinely used for administering inhalation anesthesia shall be equipped with a scavenging system to vent waste gases. If a central vacuum system is used, the gas-collecting system shall be arranged so that it does not disturb patients' respiratory systems. Gases from the scavenging system shall be exhausted directly to the outside and not be part of the recirculation system. Separate scavenging systems are not required for areas where gases are used only occasionally, such as operatories for routine dental work;

(j) In new construction, the bottoms of ventilation (supply/return) openings shall be at least three inches above the floor;

(k) All ventilation systems serving operating and recovery rooms shall be equipped with high efficiency filters having an efficiency rating of at least 90 percent, based on ASHRAE 52-76. In new construction of Type I facilities, a separate prefilter with a minimum 25 percent rating shall also be installed upstream of the air conditioning equipment, and the high efficiency filter shall be located downstream of all fans or blowers. In Type I facilities, bag type filters shall be used and a manometer shall be installed across each high efficiency filter bed. In Type II facilities, electronic filters meeting efficiency rating requirements may be substituted. A service log book shall be maintained for all electronic filter installations with a copy of the manufacturer's recommended service instructions; service shall be performed in accord with these instructions and the log book fully maintained;

(l) Where ethylene oxide is used for sterilization, provisions shall be made for complete exhaust of gases to the exterior. Provisions shall be made to insure that when the sterilizer door is open, gases are pulled away from the operator. Provisions shall also be made for appropriate aeration of supplies. Aeration cabinets shall be vented to the outside. Where aeration cabinets are not used in ethylene oxide processing, an isolated area for mechanically venting gases to the outside shall be provided;

(m) Gas and Vacuum Systems: When provided, piped in oxygen, vacuum and medical air systems shall be installed and tested prior to use in accord with NFPA 99, Chapter 4. When additions or modifications are made to a system, the entire system shall be retested.

(12) Electrical Standards: The following standards shall apply:

(a) Emergency power shall be provided to allow for continued completion of surgery or diagnostic procedures and the safe discharge of patients and conform to requirements of the Oregon Electrical Specialty Code and Chapter 3 of NFPA 99;

(b) All spaces occupied by people, machinery, or equipment within buildings, approaches to buildings, and parking lots shall have lighting;

(d) Duplex grounded-type receptacles (convenience outlets) shall be installed in all areas in sufficient quantities for tasks to be performed as needed without use of extension cords or special taps. Each examination and work table shall have access to a minimum of two duplex receptacles.

(13) Submission of Plans and Exceptions to Rules:

(a) Any party proposing to make certain alterations or additions to an existing health care facility or to construct new facilities shall, before commencing such alteration, addition or new construction, submit plans and specifications to the Office of Health Policy, Department of Human Services for preliminary inspection and approval or recommendations with respect to compliance with Health Division rules and for compliance to National Fire Protection Association standards when the facility is also to be Medicare or Medicaid certified. Submissions shall be in accord with rules of the Office of Health Policy, OAR Chapter 409, Division 17. Plans should also be submitted to the local building division having authority for review and approval in accordance with state building codes;

(b) While all Health Care Facilities 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. Requests for exceptions to the rules must be:

(A) Submitted to the Division in writing; and

(B) Identify the specific rule for which an exception is requested; and

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

(E) demonstrate that the proposed exception is desirable to maintain or improve the health and safety of the patients, and will not jeopardize patient health and safety; and

(F) The proposed duration of the exception.

(d) The facility may implement an exception only after written approval from the Health Division.

[ED. NOTE: The Table(s) referenced in this rule is not printed in the OAR Compilation. Copies are available from the agency.]

[Publications: The publication(s) referred to or incorporated by reference in this rule are available from the agency.]

333-076-0190

Emergency Preparedness

(1) The health care facility 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 health care facility 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 Department 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 Department 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;

(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;

(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;

(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 Department 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 Department 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 health care facility.

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

Stat. Auth.: ORS 441.020, 442.015
Stats. Implemented: ORS 441.020, 442.015
Hist.: PH 13-2008, f. & cert. ef. 8-15-08

Birthing Centers

333-076-0450

Definitions

(1) "Free Standing Birth Center" ("Birthing Center" or "Center") means any health care facility (HCF), licensed for the primary purpose of performing low risk deliveries that is not a hospital, or in a hospital, and where births are planned to occur away from the mother's usual residence following normal, uncomplicated pregnancy.

(2) "Division" means the Oregon Department of Human Services, Public Health Division.

(3) "Low Risk Pregnancy" means a normal, uncomplicated prenatal course as determined by documentation of adequate prenatal care, and anticipation of a normal uncomplicated labor and birth, as defined by reasonable and generally accepted criteria of maternal and fetal health.

(4) "Absolute risk factors" are those conditions that, if present, prohibit care in a birthing center.

(5) "Patient audit" means review of the clinical record and/or physical inspection of a client.

(6) "Reasonable and generally accepted criteria" means criteria or standards of care adopted by professional groups for maternal, fetal and neonatal health care, and generally accepted and followed by the care providers to whom they apply, and accepted by the Division as reasonable.

Stat. Auth.: ORS 441 & 442
Stats. Implemented: ORS 441 & 442
Hist.: HD 26-1985, f. & ef. 10-28-85; HD 2-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0400; PH 15-2006, f. & cert. ef. 6-27-06

333-076-0470

Licensing

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

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

(3) The Birthing Center license must be conspicuously posted in the area where clients are admitted.

(4) A license that has been suspended or revoked may be reissued after the Division determines that compliance with Health Care Facility laws has been achieved satisfactorily.

Stat. Auth.: ORS 441 & 442
Stats. Implemented: ORS 441 & 442
Hist.: HD 2-1990, f. 1-8-90, cert. ef. 1-15-90; PH 15-2006, f. & cert. ef. 6-27-06

333-076-0490

Submission of Plans

(1) Any party proposing to make certain alterations or additions to an existing health care facility or to construct new facilities must, before commencing such alteration, addition or new construction, submit plans and specifications to the Division for preliminary inspection and approval of recommendations with respect to compliance with Division rules. Submissions shall be in accord with, OAR 333-675-0000. Plans should also be submitted to the local building division having authority for review and approval in accordance with state building codes.

(2) Centers must keep the Division informed of any changes in ownership, organizational structure, procedures performed and privileges permitted and any information requested on the application form, in writing within 30 days of the change. Failure to notify the Division may result in revocation of license.

Stat. Auth.: ORS 441 & 442
Stats. Implemented: ORS 441 & 442
Hist.: HD 2-1990, f. 1-8-90, cert. ef. 1-15-90; PH 15-2006, f. & cert. ef. 6-27-06

333-076-0510

Expiration and Renewal of License

Each license to operate a Birthing Center will expire on December 31 following the date of issue, and if a renewal is desired, the licensee must make application at least 30 days prior to the expiration date upon a form prescribed by the Division as described in OAR 333-076-0470.

Stat. Auth.: ORS 441 & 442
Stats. Implemented: ORS 441 & 442
Hist.: HD 2-1990, f. 1-8-90, cert. ef. 1-15-90; PH 15-2006, f. & cert. ef. 6-27-06

333-076-0530

Denial or Revocation of a License

(1) A license for any Birthing Center 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 a Birthing Center must not permit, aid or abet any illegal act affecting the welfare of the license.

(3) A license will 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 a Center's substantial lack of compliance with the rules or statutes.

Stat. Auth.: ORS 441 & 442
Stats. Implemented: ORS 441 & 442
Hist.: HD 2-1990, f. 1-8-90, cert. ef. 1-15-90; PH 15-2006, f. & cert. ef. 6-27-06

333-076-0550

Return of Facility License

Each license certificate in the licensee's possession must be returned to the Division immediately on the suspension or revocation of the license, failure to renew the license by December 31, or if operation is discontinued by the voluntary action of the licensee.

Stat. Auth.: ORS 441 & 442
Stats. Implemented: ORS 441 & 442
Hist.: HD 2-1990, f. 1-8-90, cert. ef. 1-15-90; PH 15-2006, f. & cert. ef. 6-27-06

333-076-0560

Classification

(1) Health care facilities licensed by the Division may neither assume a descriptive title or be held out under any descriptive title other than the classification title established by the Division and under which the facility is licensed.

(2) No change in the licensed classification of any health care facility, as set out in this rule, may be allowed by the Division unless such facility files a new application, accompanied by the required license fee, with the Division. If the Division finds that the applicant and facility comply with Health Care Facility laws and the regulations of the Division relating to the new classification for which application for licensure is made, the Division may issue a license for such classification.

Stat. Auth.: ORS 441 & 442
Stats. Implemented: ORS 441 & 442
Hist.: HD 2-1990, f. 1-8-90, cert. ef. 1-15-90; PH 15-2006, f. & cert. ef. 6-27-06

333-076-0570

Hearings

Upon written notification by the Division of revocation, suspension or denial to issue or renew a license; a written request by the Center for a hearing in accordance with ORS 183.310 to 183.500 may be granted by the Division.

Stat. Auth.: ORS 441 & 442
Stats. Implemented: ORS 441 & 442
Hist.: HD 2-1990, f. 1-8-90, cert. ef. 1-15-90; PH 15-2006, f. & cert. ef. 6-27-06

333-076-0590

Adoption by Reference

All rules, standards and publications referred to in this division are made a part thereof. Copies are available for inspection at the Division during office hours. Where publications are in conflict with the rules, the rules govern.

Stat. Auth.: ORS 441 & 442
Stats. Implemented: ORS 441 & 442
Hist.: HD 2-1990, f. 1-8-90, cert. ef. 1-15-90; PH 15-2006, f. & cert. ef. 6-27-06

333-076-0610

Division Procedures

Inspections and 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:

(A) Interviews of the complainant, client(s), witnesses, and Center management and staff;

(B) Observations of the client(s), staff performance, client environment and physical environment; and

(b) Copies of all complaint investigations will be available from the Division provided that the identity of any complainant and any client referred to in an investigation will not be disclosed without legal authorization.

(2) Inspections:

(a) The Division may, in addition to any inspections conducted pursuant to complaint investigations, conduct at least one general inspection of each Center to determine compliance with Health Care Facility laws during each calendar year and at such other times as the Division deems necessary;

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

(d) When documents and records are requested under sections (1) or (2) of this rule, the Center must make the requested materials available to the investigator for review and copying.

Stat. Auth.: ORS 441 & 442
Stats. Implemented: ORS 441 & 442
Hist.: HD 2-1990, f. 1-8-90, cert. ef. 1-15-90; PH 15-2006, f. & cert. ef. 6-27-06

333-076-0630

Administration

Each Center must have a governing body or person clearly identified as being legally responsible for setting of policies and procedures, and assuring that they are implemented.

Stat. Auth.: ORS 441 & 442
Stats. Implemented: ORS 441 & 442
Hist.: HD 26-1985, f. & ef. 10-28-85; HD 2-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0410; PH 15-2006, f. & cert. ef. 6-27-06

333-076-0650

Service Restrictions

(1) Procedures permitted, including surgical procedures, must be limited to those directly pertaining to pregnancy, labor and delivery care of women experiencing low risk pregnancy. Procedures performed will be consistent with the individual practitioner's licensure and/or scope of practice. Tubal ligation and abortion must not be performed. Table I outlines absolute risk factors that, if present on admission to the birthing center for labor and delivery, would prohibit admission to the birthing center. Table II outlines absolute risk factors that, if they develop during labor and delivery, require transfer of the client to a higher level of care. Table III outlines absolute risk factors that, if they develop during the postpartum period in the mother or infant, would require transfer to a higher level of care.

(2) General, spinal, caudal, and/or epidural anesthesia must not be administered in the Center.

(3) Labor shall not be induced, stimulated, or augmented with chemical agents during the first or second stages of labor.

(4) Chemical agents may be administered within the individual practitioner's scope of practice to inhibit labor, as a temporary measure, until referral/transfer of the client is complete.

Stat. Auth.: ORS 441 & 442
Stats. Implemented: ORS 441 & 442
Hist.: HD 26-1985, f. & ef. 10-28-85; HD 2-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0415; PH 15-2006, f. & cert. ef. 6-27-06

333-076-0670

Policies and Procedures

Each Center must have a detailed Policies and Procedures Manual in easily accessible form, that has been approved by the governing body or person. In order to be approved by the Division for licensing purposes, these policies and procedures must meet North American Registry of Midwives (NARM) standards. All the above noted policies must be made available to representatives of the Division on request, and subject to their approval. Failure of approval will be adequate reason for the finding of deficiencies that must be corrected for continuation of licensure. The policies must be implemented as applicable, and there must be documented evidence of implementation of the above noted policies. The policies and procedures that will be developed as applicable and implemented include:

(1) A detailed organizational chart that shows the governing body or person, and clearly delineates lines of authority, responsibility and accountability for each position included in the organization, including volunteers.

(2) Staffing -- The governing body or person must ensure, through the policies and procedures, that there are adequate numbers of qualified and, where required, licensed or registered personnel on duty and immediately available to provide services intended for mothers and families, and to provide for safe maintenance of the Center.

(3) Detail of procedures to be permitted, and by whom, and method of determining the qualifications and privileges of all personnel. Staff will be required to provide documented evidence of such qualifications. Such evidence must be maintained by the Center.

(4) System for ensuring 24-hour coverage of the Center, including constant attendance by qualified attendants while a client is in the Center.

(5) System for training and for continuing education for all personnel according to their assigned duties and evaluation of skills consistent with the individual practitioners' scopes of practice. All personnel providing direct client care must be trained in cardiopulmonary resuscitation (CPR) and there must be a record of current CPR certification. In addition there must be present at each birth one practitioner trained in care and resuscitation of the newborn.

(6) System delineating how and when the Center will seek consultation with clinical specialists in obstetrics and pediatrics in order to ensure that all services, policies, and procedures meet North American Registry of Midwives (NARM) standards.

(7) Protocol for referral or transfer to appropriate health care facilities all clients whose risk status exceeds that for "low risk pregnancy."

(8) Procedures by which risk status will be assessed during the antepartal, intrapartal, and post partum period, and the identification of medical and social factors which exclude women, fetuses and newborns from the low-risk group; and for the annual review of these methods. Documentation of such assessments must be maintained in client's clinical records. Only those clients for whom prenatal and intrapartum history, physical examination, and laboratory screening procedures have demonstrated a low risk pregnancy and labor will be accepted into the Center for childbirth.

(9) System by which the Center will ensure the presence and continuing maintenance, as recommended by the manufacturer(s), of equipment needed to provide low risk maternity care, and to initiate emergency procedures in life-threatening events to the mother or baby.

(10) Plan and protocols for ensuring that emergency situations in either the mother or newborn are recognized in a timely fashion, and care is provided within the limits of the practitioner's scope of practice.

(11) System delineating how emergency transportation will be promptly available for transport of the mother and/or newborn to a health care facility with the capacity for emergency care of women, in all the stages of labor, and newborns. The written policy must include a listing of situations for the mother and/or newborn that would have the potential to necessitate emergency transfer. The policy must also include the requirement that a transfer plan for each patient be developed.

(12) Systems for ensuring the orientation and education of women and families registering for care at the Center so that they will be informed as to the benefits and risks of the services available to them at the Center and the qualifications and licensure status of practitioners at the Center. They must be fully informed of the risk criteria as defined in OAR 333-076-0650 and provide written consent. The client, as a part of the informed consent, must also agree in advance to transfer to another clinician or appropriate health care facility, should the need occur due to the development of unexpected risk factors after admission to the Center. The client must be informed of the benefits and risks of such a transfer.

(13) System for the sterilization of equipment and supplies, unless only pre-packaged and pre-sterilized items are used.

(14) System to ensure the performance of appropriate laboratory studies and to ensure that the results are available in a timely manner.

(15) System for the storage and administration of drugs. All medications must be prescribed and/or administered within the individual practitioner's licensure and/or scope of practice.

(16) System to ensure the timely administration of Rh immune globulin to the mother, where applicable.

(17) System to ensure the timely appropriate administration of Vitamin K to the newborn, according to rules of the Division.

(a) The purpose of ORS 433.303 to 433.314 is to protect newborn infants against hemorrhagic disease of the newborn.

(b) The Vitamin K forms suitable for use are forms of Vitamin K1 (Phytonadione), available in injectable or oral forms: as Mephyton for oral use, or as aquamephyton or konakion for injectable use. The Vitamin K dose is to be administered within the first 24 hours of delivery. Menadione (Vitamin K3) is not recommended for prophylaxis and treatment of hemorrhagic disease of the newborn.

(c) The dose of any of the Vitamin K1 forms to be administered is one dose of 0.5 to 1.0 mg., if given by injection, or one dose of 1.0 to 2.0 mg. if given orally.

(d) A parent may, after being provided a full and clear explanation, decline to permit the administration of Vitamin K based on religious tenets and practices. In this event, the parent must sign a form acknowledging his/her understanding of the reason for administration of Vitamin K and possible adverse consequences in the presence of a person who witnessed the instruction of the parent, and who must also sign the form. The form must become a part of the clinical record of the newborn infant.

(18) System to ensure the timely and appropriate collection of blood from the newborn for testing by the State Laboratory, Newborn Screening Program, for the Metabolic Diseases listed in 333-024-0210.

(19) Protocol delineating the steps to ensure the prompt and safe evacuation of the Center in the event of emergency situations, such as fire. The Center must ensure the evaluation of staff in managing such situations by periodic drills for fire, and/or other emergencies. Such drills must be documented.

(20) System of infection control to address the prevention and early recognition of the possibility of infection, and timely and acceptable methods of control. This includes written documentation of the problem, and measures taken for control, and must at least meet the requirements of the rules of the Division. Documentation must also include methods for the control and prevention of cross-infection between clients and services in accordance with 2003 Center for Disease Control and Prevention "Guidelines for Environmental Infection Control in Health-Care Facilities."

(21) System to be used for the prevention of Ophthalmia Neonatorum in the newborn OAR 333-019-0036(2). Prophylaxis for Gonococcal Ophthalmia Neonatorum:

(a) The practitioner attending the birth of an infant must, after evaluating the infant as being at risk and within two hours of delivery, instill appropriate prophylactic antibiotic ointment from single patient use applicators into each eye of the newborn infant;

(b) Parent(s) refusing to allow prophylaxis for their infant(s) must be informed, by the attending Health Care Provider, of the risks attendant to such action and must sign a witnessed affidavit to testify that they have been so informed and nonetheless refuse to allow prophylaxis.

(c) If Vitamin K and/or Gonococcal Ophthalmia Neonatorum Prophylaxis cannot be administered by the individual delivering the newborn, methods must be described to ensure that these services are arranged by referral.

(22) System to ensure that appropriate vital records are filed according to the rules of the Division.

(23) System for a semi-annual clinical record audit to evaluate the care process and outcome.

Stat. Auth.: ORS 441 & 442
Stats. Implemented: ORS 441 & 442
Hist.: HD 26-1985, f. & ef. 10-28-85; HD 2-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0420; PH 15-2006, f. & cert. ef. 6-27-06

333-076-0690

Health and Medical Records

Health and Clinical Records must be developed according to procedures outlined in the Policy and Procedures Manual as a legal record and an instrument for the continuity of care and must include:

(1) Contents -- The records of each client must contain:

(a) Demographic data, initial prenatal physical examination, laboratory tests and evaluation of risk status;

(b) Continuous periodic prenatal examination and evaluation of risk status;

(d) History, physical examination and risk assessment on admission to the Center in labor (including assessment of mother and fetus);

(e) Continuous assessment of the mother and fetus during labor and delivery;

(f) Labor summary;

(g) The emergency transport plan for the client;

(h) Physical assessment of newborn, including Apgar scores and vital signs;

(i) Post partum evaluation of the mother;

(j) Discharge summary for mother and newborn;

(k) Documentation of consultation, referral, and/or transfer;

(l) Signed documents as may be required by law; and

(m) Records of newborn and stillborn infants must include, in addition to the requirement for medical records, the following information:

(A) Date and hour of birth, birth weight and length of infant, period of gestation, sex, and condition of infant on delivery;

(B) Mother's name;

(D) Progress notes including:

(i) Temperature, weight and feeding data;

(ii) Number, consistency and color of stools;

(iii) Urinary output;

(iv) Condition of eyes and umbilical cord;

(v) Condition and color of skin; and

(vi) Motor behavior.

(2) All entries in a client's labor record must be dated, timed, and authenticated. Verification of an entry requires use of a unique identifier, i.e., signature, code, thumbprint, voice print or other means, that allows identification of the individual responsible for the entry.

(3) A single signature or authentication of the responsible practitioner on the clinical record does not suffice to cover the entire content of the record.

(4) The completion of the clinical record must be the responsibility of the attending practitioner.

(5) The Center will ensure that the prenatal and intrapartal records are available at the time of admission and in the event of transfer to the care of another clinician or health care facility.

(6) Storage -- The records will be stored in such a way as to minimize the chance of their destruction by fire or other source of loss or damage and to ensure prevention of access by unauthorized persons.

(7) Records are the property of the Center, and will be kept confidential unless released by the permission of the client. An exception is that they may be reviewed by representatives of the Division, and will be provided in copy form to such representatives on request.

(8) All clinical records must be kept for a period of at least twenty-one years after the date of last discharge. Original clinical records may be retained on paper, microfilm, electronic or other media.

(9) If a Center changes ownership all clinical records in original, electronic, or microfilm form must remain in the Center, and it must be the responsibility of the new owner to protect and maintain these records.

(10) If a Birthing Center must be closed, its clinical records may be delivered and turned over to any other health care facility in the vicinity willing to accept and maintain the same as provided in section (8) of this rule.

(11) If a qualified clinical record practitioner, RHIA (Registered Health Information Administrator) or RHIT (Registered Health Information Technician) is not the Director of the Clinical Records Department, the Division may require the Center to obtain periodic and at least annual consultation from a qualified clinical records consultant, RHIA/RHIT. The visits of the clinical records consultant must be of sufficient duration and frequency to review clinical record systems and assure quality records of the clients. Contract for such services must be available to the Division.

Stat. Auth.: ORS 441 & 442
Stats. Implemented: ORS 441 & 442
Hist.: HD 26-1985, f. & ef. 10-28-85; HD 2-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0425; PH 15-2006, f. & cert. ef. 6-27-06

333-076-0710

Physical Facility

(1) Design -- The Center may be an adaptation of a house. It must include birthing rooms of adequate size to meet the needs to accomplish the procedures specified in the Policies and Procedures and must meet applicable codes for ordinary construction and for water supply and sewage disposal. The building and equipment must be kept clean and in good repair. The Center must include:

(a) Toilet facilities for staff, mothers and families;

(b) Bath facilities;

(c) Hand washing facilities and single use towel dispensers adjacent or closely available to all examining or birth rooms;

(d) Examination areas;

(e) Laundry facilities (unless laundry is done elsewhere);

(f) Kitchen facilities;

(g) Adequate storage areas for emergency equipment;

(h) Separate storage for clean/sterile supplies and equipment;

(i) Storage areas for laboratory equipment and sterilizing, if applicable;

(j) Space for resuscitation of the newborn; and

(k) Reception and family facilities.

(2) Client Environment:

(a) There must be provided for each client a good bed, mattress and pillow with protective coverage, and necessary bed coverings;

(b) No towels, wash cloths, bath blankets, or other linen which comes directly in contact with the client will be interchangeable from one client to another unless it is first laundered;

(d) After the discharge of any client, the bed, bed furnishings, bedside furniture and equipment must be thoroughly cleaned and disinfected prior to reuse. Mattresses must be professionally renovated when necessary.

(3) Provision must be made for the safe disposal of any bodily wastes that result from procedures performed in accordance with Centers for Disease Control and Prevention recommendations and state law.

(4) Fire and Safety -- State and local fire and life-safety codes apply with specific attention to demonstration of adequate ingress and egress of occupants, placement of smoke alarms, emergency lighting, fire extinguishers or sprinkler systems, fire escape routes, and fire reporting plans. The Center must have an emergency plan in effect on premises available to all staff. There must be evidence of an annual fire inspection.

(5) Emergency Access -- Hallways and doorways must be so sized and arranged as to ensure the reasonable access of equipment in the event of the need for emergency transport.

(6) Emergency preparedness:

(a) The health care facility 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 health care facility 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.

(b) 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.

(c) The summary of the emergency plan shall be sent to the Department 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 Department shall request updated plans as needed.

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

(A) Chemical emergencies;

(B) Dam failure;

(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.

(e) 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;

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

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

(f) 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;

(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 Department about the status of the evacuation.

(g) 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, or the use of other emergency personnel.

(h) The emergency plan shall be made available as requested by the Department 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 health care facility.

Stat. Auth.: ORS 441.020 & 442.015
Stats. Implemented: ORS 441.020 & 442.015
Hist.: HD 26-1985, f. & ef. 10-28-85; HD 2-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0430; PH 15-2006, f. & cert. ef. 6-27-06; PH 13-2008, f. & cert. ef. 8-15-08

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