The Oregon Administrative Rules contain OARs filed through November 15, 2015
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OREGON HEALTH AUTHORITY,
PUBLIC HEALTH DIVISION
DIVISION 76
SPECIAL HEALTH CARE FACILITIES
Ambulatory Surgical Centers ASC
333-076-0001
Referenced Codes and Standards
The codes and standards referenced in these
rules shall be considered part of the requirements of these rules to the prescribed
extent of each such reference. Where differences occur between provisions of these
rules and referenced codes and standards, the provisions of the most restrictive
code shall apply.
(1) 2010 Oregon Structural Specialty
Code (OSSC);
(2) 2010 Oregon Mechanical Specialty
Code;
(3) 2010 Oregon Energy Efficiency
Specialty Code;
(4) 2010 Oregon Electrical Specialty
Code (OESC);
(5) 2011 Oregon Plumbing Specialty
Code;
(6) 2010 Oregon Fire Code (OFC);
(7) National Fire Protection
Association, NFPA 101 Life Safety Code, 2000 Edition;
(8) National Fire Protection
Association, NFPA 99 Standard for Healthcare Facilities, 1999 Edition;
(9) National Fire Protection
Association, NFPA 110 Standard for Emergency and Standby Power Systems, 2002 Edition;
(10) National Fire Protection
Association, NFPA 90A Standard for Installation of Air-Conditioning and Ventilating
Systems, 1996 Edition;
(11) National Fire Protection
Association, NFPA 255 Standard Method of Test of Surface Burning Characteristics
of Building Materials, 2000 Edition;
(12) National Fire Protection
Association, NFPA 801 Standard for Fire Protection for Facilities Handling Radioactive
Materials, 1998 Edition OSHA and radiology;
(13) Illuminating Engineering
Society, IES RP 28, 2007 Edition;
(14) Illuminating Engineering
Society, IES RP 29, 2006 Edition with Errata;
(15) American National Standards
Institute/American Society of Sanitary Engineering, ANSI/ASSE 6000, 2004 edition;
(16) ASHRAE Standard 170-2008 Ventilation of Health Care Facilities;
(17) Underwriters Laboratories,
Inc.; UL 1069 Hospital Signaling and Nurse Call Equipment, 7th edition, revised
January 22, 2009;
(18) National Fire Protection
Association, NFPA 13, Standard for Installation of Sprinkler Systems, 1999 Edition;
(19) National Fire Protection
Association, NFPA 72, Standard for Installation of Sprinkler Systems, 1999 Edition.
Stat. Auth.: ORS 441.025 &
441.060
Stats. Implemented: ORS 441.025
& 441.060
Hist.: PH 5-2012, f. 3-30-12,
cert. ef. 4-1-12
333-076-0101
Definitions
As used in OAR chapter 333, division 76 unless the context requires otherwise, the following definitions apply:
(1) "Ambulatory Surgical Center" (ASC) means:
(a) A facility or portion of a facility that operates exclusively for the purpose of providing surgical services to patients who do not require hospitalization and for whom the expected duration of services does not exceed 24 hours following admission.
(b) Ambulatory surgical center does not mean:
(A) Individual or group practice offices of private physicians or dentists that do not contain a distinct area used for outpatient surgical treatment on a regular and organized basis, or that only provide surgery routinely provided in a physician’s or dentist’s office using local anesthesia or conscious sedation; or
(B) A portion of a licensed hospital designated for outpatient surgical treatment.
(2) "Authentication" means verification that an entry in the patient medical record is genuine.
(3) “CMS” means Centers for Medicare and Medicaid Services.
(4) “Certified ambulatory surgical center” means a facility that is licensed by the Division and is deemed as meeting the Medicare Conditions of Participation for ambulatory surgical services, 42 CFR 416, Subpart C.
(5) "Certified Nurse Anesthetist" (CRNA) means a registered nurse certified by the Council on Certification of Nurse Anesthetists and licensed by the Oregon State Board of Nursing.
(6) “Conditions of Participation” mean the applicable federal regulations that ASCs are required to comply with in order to participate in the federal Medicare and Medicaid programs.
(7) “Conscious sedation” means an induced controlled state of minimally depressed consciousness in which the patient retains the ability to independently and continuously maintain an airway and to respond purposefully to physical stimulation and to verbal command.
(8) “Deemed” means a health care facility that has been inspected by an approved accrediting organization and has been approved by the CMS as meeting CMS Conditions of Participation.
(9) “Deep sedation” means an induced controlled state of depressed consciousness in which the patient experiences a partial loss of protective reflexes, as evidenced by the inability to respond purposefully either to physical stimulation or to verbal command but the patient retains the ability to independently and continuously maintain an airway.
(10) “Direct ownership” has the meaning given the term ‘ownership interest’ in 42 CFR 420.201.
(11) "Division" means the Public Health Division of the Oregon Health Authority.
(12) “Financial interest” means a five percent or greater direct or indirect ownership interest.
(13) “General anesthesia” means an induced controlled state of unconsciousness in which the patient experiences complete loss of protective reflexes, as evidenced by the inability to independently maintain an airway, the inability to respond purposefully to physical stimulation, or the inability to respond purposefully to verbal command.
(14) "Governing body" means the body or person legally responsible for the direction and control of the operation of the facility.
(15) "Health Care Facility" (HCF) has the meaning given the term in ORS 442.015.
(16) "Health Care Facility Licensing Law" means ORS 441.015-441.990 and rules thereunder.
(17) “High complexity non-certified” means a facility that is licensed by the Division, is not deemed as meeting the Medicare Conditions of Participation for ambulatory surgical services, 42 CFR 416, Subpart C, and performs surgical procedures involving deep sedation or general anesthesia.
(18) "Hospital" has the meaning given that term in ORS 442.015.
(19) “Indirect ownership” has the meaning given the term ‘indirect ownership interest’ in 42 CFR 420.201.
(20) "Licensed" means that the person or facility to whom the term is applied is currently licensed, certified or registered by the proper authority to follow his or her profession or vocation within the State of Oregon, and when applied to a health care facility means that the facility is currently and has been duly and regularly licensed by the Division.
(21) "Licensed Nurse" means a Registered Nurse (RN) or a Licensed Practical Nurse (LPN).
(22) "Licensed Practical Nurse" (LPN) means a person licensed under ORS chapter 678 to practice practical nursing.
(23) “Local anesthesia” means the administration of an agent that produces a transient and reversible loss of sensation in a circumscribed portion of the body.
(24) “Moderate complexity non-certified” means a facility licensed by the Division, is not deemed as meeting the Medicare Conditions of Participation for ambulatory surgical services, 42 CFR 416, Subpart C, and performs procedures requiring not more than conscious sedation.
(25) "New construction" means a new building or an addition to an existing building.
(26) "NFPA" means National Fire Protection Association.
(27) "Nursing Assistant" means a person certified as meeting the educational requirements established by the Oregon State Board of Nursing (OSBN). Responsibilities shall be limited to functions included in a course curricula approved by OSBN.
(28) "Patient audit" means review of the medical record and/or physical inspection of a patient.
(29) "Person" means an individual, a trust or estate, or a partnership or corporation (including associations, joint stock companies and insurance companies, a state or a political subdivision or instrumentality including a municipal corporation).
(30) "Physician" means a person licensed under ORS chapter 677 to practice medicine by the Oregon Medical Board.
(31) "Podiatrist" means a person licensed under ORS chapter 677 to practice podiatry.
(32) "Podiatry" means the diagnosis or the medical, physical or surgical treatment of ailments of the human foot, except treatment involving the use of a general or spinal anesthetic unless the treatment is performed in a hospital certified in the manner described in subsection (2) of ORS 441.055 and is under the supervision of or in collaboration with a physician licensed to practice medicine by the Oregon Medical Board. "Podiatry" does not include the administration of general or spinal anesthetics or the amputation of the foot.
(33) "Registered Nurse" (RN) means a person licensed as a Registered Nurse under ORS chapter 678.
Stat. Auth.: ORS 441.025 & 441.057
Stats. Implemented: ORS 441.020, 441.025, 441.057, 441.098, & 442.015
Hist.: HD 3-1990, f. 1-8-90, cert. ef. 1-15-90; PH 4-2006(Temp), f. & cert. ef. 3-2-06 thru 8-1-06; Administrative correction 8-22-06; PH 25-2006, f. 10-31-06, cert. ef. 11-1-06; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
333-076-0106
Issuance of License and Fees
(1) Application for a license to operate an ASC shall be in writing on a form provided by the Division, including demographic, ownership and administrative information. The form shall specify such information required by the Division.
(2) For purposes of determining the correct license fee required under ORS 441.020 and this rule:
(a) “Procedure room” means a room where surgery or invasive procedures are performed; and
(b) “Invasive procedure” means a procedure requiring insertion of an instrument or device into the body through the skin or a body orifice for diagnosis or treatment, and operative procedures in which skin or mucous membranes and connective tissue are incised, or an instrument is introduced through a natural body orifice.
(3) Upon receipt of an application and the license fee as described in ORS 441.020, the Division shall review the application and conduct an on-site inspection of the ASC.
(4) In lieu of an onsite inspection required under section (3) of this rule, the Division may accept:
(a) CMS certification by a federal agency or accrediting organization; or
(b) A survey conducted within the previous three years by an accrediting organization approved by the Division, if:
(A) The certification or accreditation is recognized by the Division as addressing the standards and condition of participation requirements of the CMS and other standards set by the Division and an ASC provides the Division with a letter from CMS indicating its deemed status;
(B) The ASC notifies the Division of any exit interview conducted by the federal agency or accrediting body and permits the Division to participate; and
(C) The ASC provides copies of all documentation concerning the certification or accreditation requested by the Division.
(5) If the deemed status of an ASC changes, the ASC administrator must notify the Division.
(6) No person or ASC licensed pursuant to the provisions of ORS chapter 441, shall in any manner or by any means assert, represent, offer, provide or imply that such person or facility is or may render care or services other than that which is permitted by or which is within the scope of the license issued to such person or facility by the Division nor shall any service be offered or provided which is not authorized within the scope of the license issued to such person or facility.
(7) The Division shall issue a license to an ASC that:
(a) Submits a completed application as described in section (1) of this rule;
(b) Submits the license fee as described in ORS 441.020;
(c) Successfully completes the survey requirements established in this rule or provides documentation acceptable to the Division under section (4) of this rule; and
(d) Is found by the Division to be in compliance with applicable statutes and these rules.
(8) In determining whether to license an ASC pursuant to ORS 441.025, the Division shall consider only factors relating to the health and safety of individuals to be cared for therein and the ability of the operator of the ASC to safely operate the facility, and shall not consider whether the ASC is or will be a governmental, charitable, or other nonprofit institution or whether it is or will be an institution for profit.
(9) The license shall be conspicuously posted in the area where patients are admitted.
(10) A facility license that has been suspended or revoked may be reissued after the Division determines that compliance with HCF laws has been achieved satisfactorily.
Stat. Auth.: ORS 441.025
Stats. Implemented: ORS 441.022 & 441.025
Hist.: HD 3-1990, f. 1-8-90, cert. ef. 1-15-90; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
333-076-0108
Expiration and Renewal of License
Each license to operate an ASC shall expire on December 31 following the date of issue, and if a renewal is desired, the licensee shall make application at least 30 days prior to the expiration date upon a form prescribed by the Division as described in OAR 333-076-0106.
Stat. Auth.: ORS 441.025
Stats. Implemented: ORS 441.025
Hist.: HD 3-1990, f. 1-8-90, cert. ef. 1-15-90; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
333-076-0109
Denial or Revocation of a License
(1) A license for any ASC may be denied, suspended or revoked by the Division when the Division finds that there has been a substantial failure to comply with the provisions of Health Care Facility licensing law.
(2) A person or persons in charge of an ASC shall not permit, aid or abet any illegal act affecting the welfare of the license.
(3) A license shall be denied, suspended or revoked in any case where the State Fire Marshal certifies that there was failure to comply with all applicable laws, lawful ordinances and rules relating to safety from fire.
(4) A license may be suspended or revoked for failure to comply with a Division order arising from an ASC's substantial lack of compliance with the rules or statutes.
Stat. Auth.: ORS 441.025
Stats. Implemented: ORS 441.025 & 441.030
Hist.: HD 3-1990, f. 1-8-90, cert. ef. 1-15-90; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
333-076-0110
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 441.025
Stats. Implemented: ORS 441.025
Hist.: HD 3-1990, f. 1-8-90, cert. ef. 1-15-90
333-076-0111
Classification
(1) Ambulatory surgical centers shall be classified as follows:
(a) Certified;
(b) High complexity non-certified; and
(c) Moderate complexity non-certified.
(2) The classification of each ASC shall be so designated on the license.
(3) ASCs licensed by the Division shall neither assume a descriptive title nor be held out under any descriptive title other than the classification title established by the Division and under which the facility is licensed. This not only applies to the name on the facility but where stationery, advertising and other representations are involved.
(4) No change in the licensed classification of any ASC, as set out in this rule, shall be allowed by the Division unless such facility shall file a new application, accompanied by the required license fee, with the Division. If the Division finds that the applicant and facility comply with HCF laws and the regulations of the Division relating to the new classification for which application for licensure is made, the Division shall issue a license for such classification.
Stat. Auth.: ORS 441.025 & 441.086
Stats. Implemented: ORS 441.025 & 441.086
Hist.: HD 3-1990, f. 1-8-90, cert. ef. 1-15-90; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
333-076-0112
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 183.410 to 183.500 shall be granted by the Division.
Stat. Auth.: ORS 441.025
Stats. Implemented: ORS 183.413 - 183.500 & 441.037
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 441.025
Stats. Implemented: ORS 441.025
Hist.: HD 3-1990, f. 1-8-90, cert. ef. 1-15-90
333-076-0114
Inspections and Complaint Investigations
(1) Complaints:
(a) Any person may make a complaint to the Division regarding violation of health care facility laws or regulations. A complaint investigation will be carried out as soon as practicable and may include but not be limited to, as applicable to facts alleged: interviews of the complainant, patient(s), witnesses, and ASC management and staff; observations of the patient(s), staff performance, patient environment and physical environment; and review of documents and records;
(b) An ASC shall post a notice in the facility, in a prominent place and size that must include, but is not limited to the following: "If you have concerns about this ambulatory surgical center and the services provided here, contact the Public Health Division, Health Care Regulation and Quality Improvement Program: 800 NE Oregon Street, Suite 305, Portland OR 97232; 971-673-0540."
(c) Information obtained by the Division during an investigation of a complaint or reported violation is confidential and not subject to public disclosure under ORS 192.410 to 192.505. Upon the conclusion of the investigation, the Division may publicly release a report of its findings but may not include information in the report that could be used to identify the complainant or any patient at the ASC.
(d) The Division may use any information obtained during an investigation in an administrative or judicial proceeding concerning the licensing of an ASC, and may report information obtained during an investigation to a health professional regulatory board as defined in ORS 675.160 as that information pertains to a licensee of the board.
(2) Inspections:
(a) The Division will, in addition to any inspections conducted pursuant to complaint investigations, conduct at least one general inspection of each ASC to determine compliance with HCF laws at least once every three years and at such other times as the Division deems necessary. The Division may accept certificates from accrediting organizations approved by the Division as evidence of compliance with acceptable standards in lieu of ASC inspections;
(b) Facilities providing approved accrediting organization certificates as evidence of compliance shall also be required to provide to the Division (or to have previously provided) with each license application (and license renewal application):
(A) All approved accrediting organizations survey and inspection reports; and
(B) Written evidence of all corrective actions underway, or completed, in response to approved accrediting organizations recommendations; including all progress reports.
(c) Inspections will include but not be limited to those procedures stated in subsection (1)(a) of this rule;
(d) The inspection may include a patient audit, the results of which shall be summarized on the licensing survey form;
(e) When documents and records are requested under section (1) or (2) of this rule, the ASC shall make the requested materials available to the investigator for review and copying.
Stat. Auth.: ORS 441.025
Stats. Implemented: ORS 441.025, 441.060 & 441.086
Hist.: HD 3-1990, f. 1-8-90, cert. ef. 1-15-90; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
333-076-0115
Governing Body Responsibility
The governing body of each ASC shall be responsible for the operation of the facility, the selection of the medical staff and the quality of care rendered in the facility. The governing body shall:
(1) Insure that all health care personnel for whom state licenses or registration are required are currently licensed or registered;
(2) Insure that physicians admitted to practice in the facility are granted privileges consistent with their individual training, experience and other qualifications;
(3) Insure that procedures for granting, restricting and terminating privileges exist and that such procedures are regularly reviewed to assure their conformity to applicable law;
(4) Insure that physicians admitted to practice in the facility are organized into a medical staff insofar as applicable in such a manner as to effectively review the professional practices of the facility for the purposes of reducing morbidity and mortality and for the improvement of patient care; and
(5) Insure that a physician is not denied medical staff membership or privileges at the facility solely on the basis that the physician holds medical staff membership or privileges at another ASC.
Stat. Auth.: ORS 441.025
Stats. Implemented: ORS 441.025 & 441.055
Hist.: HD 11-1980, f. & ef. 9-10-80; HD 25-1983(Temp), f. & ef. 12-21-83; HD 23-1985, f. & ef. 10-11-85; Renumbered from 333-023-0163(1); HD 3-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0100(1)(a) & (b); PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
333-076-0120
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 Oregon Medical Board;
(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 441.025
Stats. Implemented: ORS 441.055
Hist.: HD 3-1990, f. 1-8-90, cert. ef. 1-15-90
333-076-0125
Personnel
(1) As used in this rule, “person” means any:
(a) ASC employee;
(b) ASC contractor;
(c) Health care practitioner granted privileges by the ASC; or
(d) ASC volunteer or student.
(2) The facility shall maintain a sufficient number of qualified personnel to provide effective patient care and all other related services.
(3) There shall be written personnel policies and procedures which shall be made available to personnel.
(4) Provisions shall be made for orientation.
(5) Provisions shall be made for an annual continuing education plan.
(6) There shall be a job description for each position which delineates the qualifications, duties, authority and responsibilities inherent in each position.
(7) There shall be an annual work performance evaluation for each employee with appropriate records maintained.
(8) There shall be an employee health screening program for the purpose of protecting patients and employees from communicable diseases, including but not limited to requiring tuberculosis testing for employees in accordance with section (10) of this rule.
(9) An ASC shall restrict the work of employees with restrictable diseases in accordance with OAR 333-019-0010.
(10) Each ASC shall formally assess the risk of tuberculosis transmission among ASC employees, contractors, health care practitioners granted privileges by the ASC, volunteers or students, and shall comply with the "Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings," published by the Centers for Disease Control and Prevention (Morbidity and Mortality Weekly Report, vol. 54, number RR-17, December 30, 2005 or by following recommendations otherwise approved by the Division.
(11) An ASC shall obtain documentation that tuberculosis (TB) testing has been conducted in a manner consistent with the CDC guidelines for any person who enters an ASC and who has contact with patients, enters rooms that patients may enter, or who handles clinical specimens or other material from patients or their rooms.
(a) An ASC shall require documentation of baseline TB screening conducted in accordance with the CDC Guidelines, within six weeks of the date of hire, date of executed contract or date of being granted ASC credentials.
(b) For persons hired, contracted with or granted ASC privileges prior to December 15, 2010, an ASC shall obtain documentation of compliance with CDC Guidelines by February 1, 2011.
(12) An ASC that is classified as "potential ongoing transmission" under CDC Guidelines shall consult with the Oregon TB control program within the Division, for guidance on the extent of TB testing required.
(13) If an ASC learns that a person or a patient at the hospital is diagnosed with communicable TB, the ASC shall notify the local public health authority and conduct an investigation to identify contacts. If the Division or local public health authority conducts its own investigation, an ASC shall cooperate with that investigation and provide the Division or local public health authority with any information necessary for it to conduct its investigation.
(14) An ASC shall notify the local public health administrator of its intent to discharge a patient known to have active TB disease.
(15) The actions taken under this rule and all results thereof shall be fully documented for each employee. Such documentation is subject to review by authorized representatives of the Division.
[Publications: Publications referenced are available from the agency.]
Stat. Auth.: ORS 441.025
Stats. Implemented: ORS 433.411, 441.025, 441.057, 441.162, 678.362
Hist.: HD 3-1990, f. 1-8-90, cert. ef. 1-15-90; PH 4-2006(Temp), f. & cert. ef. 3-2-06 thru 8-1-06; Administrative correction 8-22-06; PH 25-2006, f. 10-31-06, cert. ef. 11-1-06; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
333-076-0130
Policies and Procedures
The governing body shall have a formal organizational plan with written policies, procedures and by-laws that are enforced and that clearly set forth the organizational plan with written responsibilities, accountability and relationships of professional and other personnel including volunteers.
(1) The clinical services of each ASC shall be under the supervision of a manager who shall be an RN or a physician.
(2) The following are written policies and procedures that the ASC shall develop and implement:
(a) Types of procedures that may be performed in the facility;
(b) Types of anesthesia that may be used including storage procedures. Where inhalation anesthetics and medical gases are used there shall be procedures to assure safety in storage and use;
(c) Criteria for evaluating patient before admission and before discharge or transfer;
(d) Nursing service activities;
(e) Infection control;
(f) Visitor's conduct and control;
(g) Criteria and procedures for admission of physicians, dentists, or other individuals within the scope of his or her license, to the staff;
(h) Content and form of medical records;
(i) Procedures for storage and dispensing of clean and sterile supplies and equipment and the processing and sterilizing of all supplies, instruments and equipment used in procedures unless disposable sterile packs are used;
(j) Procedures for the disposal of pathological and other potentially infectious waste and contaminated supplies. Guidelines established by the Division shall be used in developing these procedures;
(k) Procedures for the procurement, storage and dispensing of drugs;
(l) If the program calls for the serving of snacks or other foods procedures shall be written covering space, equipment and supplies. Arrangements may be made for outside services. All food services shall meet the requirements of the Food Sanitation Rules, OAR 333-150-0000;
(m) Procedures for the cleaning, storage and handling of soiled linen and the storage and handling of clean linen;
(n) Policies and procedures relating to routine laboratory testing;
(o) A policy and procedure which assures at least annual training in emergency procedures, including, but not limited to:
(A) Procedures for fire and other disaster;
(B) Infection control measures; and
(C) For staff involved in direct patient care, procedures for life threatening situations including, but not limited to, cardiopulmonary resuscitation and the life saving techniques for choking;
(p) Policies and procedures for essential life saving measures and stabilization of a patient and arrangements for transfer to an appropriate facility;
(q) Procedures for notifying patients orally and in writing of any financial interest as required by ORS 441.098;
(r) Requirements for informed consent signed by the patient or legal representative of the patient for diagnostic and treatment procedures; such policies and procedures shall address informed consent of minors in accordance with provisions in ORS 109.610, 109.640, 109.670, and 109.675; and
(s) Requirements for identifying persons responsible for obtaining informed consent and other appropriate disclosures and ensuring that the information provided is accurate.
Stat. Auth.: ORS 441.025 & 441.057
Stats. Implemented: ORS 441.025, 441.057, 441.162, & 678.362
Hist.: HD 11-1980, f. & ef. 9-10-80; HD 25-1983(Temp), f. & ef. 12-21-83; HD 23-1985, f. & ef. 10-11-85; Renumbered from 333-023-0163(1); HD 3-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0100(2)(a) & (b)(A) - (Q); PH 4-2006(Temp), f. & cert. ef. 3-2-06 thru 8-1-06; Administrative correction 8-22-06; PH 25-2006, f. 10-31-06, cert. ef. 11-1-06; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
333-076-0135
Nursing Services
(1) An RN shall be responsible for the nursing care provided to the patients.
(2) The number and types of nursing personnel, including RNs, LPNs and nursing and surgical assistants shall be based on the needs of the patients and the types of services performed.
(3) At least one RN and one other nursing staff member shall be on duty at all times patients are present.
(4)(a) For purposes of this rule, "circulating nurse" means a registered nurse who is responsible for coordinating the nursing care and safety needs of the patient in the operating room and who also meets the needs of operating room team members during surgery.
(b) The duties of a circulating nurse performed in an operating room of a certified or high complexity non-certified ambulatory surgical center shall be performed by a registered nurse licensed under ORS 678.010-678.410.
(c) In any case requiring anesthesia or conscious sedation, a circulating nurse shall be assigned to, and present in, an operating room for the duration of the surgical procedure unless it becomes necessary for the circulating nurse to leave the operating room as part of the surgical procedure. While assigned to a surgical procedure, a circulating nurse may not be assigned to any other patient or procedure.
(d) Nothing in this rule precludes a circulating nurse from being relieved during a surgical procedure by another circulating nurse assigned to continue the surgical procedure.
(5) Nurses who supervise the recovery area shall have current training in resuscitation techniques and other emergency procedures.
Stat. Auth.: ORS 441.025 & 441.057
Stats. Implemented: ORS 441.025, 441.057, 441.162, & 678.362
Hist.: HD 11-1980, f. & ef. 9-10-80; HD 25-1983(Temp), f. & ef. 12-21-83; HD 23-1985, f. & ef. 10-11-85; Renumbered from 333-023-0163(1); HD 3-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0100(4)(a) - (c); PH 4-2006(Temp), f. & cert. ef. 3-2-06 thru 8-1-06; Administrative correction 8-22-06; PH 25-2006, f. 10-31-06, cert. ef. 11-1-06; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
333-076-0140
Anesthesia Services (If Provided)
(1) General or spinal anesthesia shall be administered only by a physician or a certified nurse anesthetist. Either the physician or the CRNA shall be present for the administration of general or spinal anesthetics, during anesthesia, and the recovery of the patients when any general or spinal anesthesia is used.
(2) In all areas where flammable anesthetics are used, such rooms shall be equipped and maintained in compliance with provisions of the current issue of NFPA 99, Standard for Health Care Facilities, unless the governing body's written policy forbids the use or storage of flammable anesthetics in the facility.
[Publications: Publications referenced are available from the agency.]
Stat. Auth.: ORS 441.025
Stats. Implemented: ORS 441.025
Hist.: HD 11-1980, f. & ef. 9-10-80; HD 25-1983(Temp), f. & ef. 12-21-83; HD 23-1985, f. & ef. 10-11-85; Renumbered from 333-023-0163(1); HD 3-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0100(5)(a) & (b); PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
333-076-0145
Storage, Disposal and Dispensing of Drugs
(1) In an ASC that does not have a pharmacy on the premises, stock quantities of prescription drugs, including local anesthetics shall be stored on the premises only when such drugs have been obtained for dispensation or administration to his/her respective patients by a physician, dentist, podiatrist or other person authorized within the scope of his/her license to so dispense or administer such drugs. Prescribed drugs already prepared for patients in the ASC may also be stored on the premises.
(2) Old medications, including special prescriptions for patients who have left the facility, shall be disposed of by incineration or other equally effective method, except narcotics and other drugs under the drug abuse law, which shall be handled in the manner prescribed by the Drug Enforcement Administration of the United States Department of Justice.
(3) Drugs shall not be administered to patients unless ordered by a physician, dentist, podiatrist or individual authorized within the scope of his or her professional license to prescribe drugs; and such order shall be in writing over the physician's or other authorized individual's signature or authentication.
(4) Prescription drugs dispensed by a physician shall be personally dispensed by the physician. Nonjudgmental dispensing functions may be delegated to staff assistants when the accuracy and completeness of the prescription is verified by the physician.
(5) The dispensing physician shall label prescription drugs with the following information:
(a) Name of patient;
(b) The name and address of the dispensing physician;
(c) Date of dispensing;
(d) The name of the drug. If the dispensed drug does not have a brand name, the prescription label shall indicate the generic name of the drug dispensed along with the name of the drug distributor or manufacturer, its quantity per unit and the directions for its use stated in the prescription. However, if the drug is a compound, the quantity per unit need not be stated;
(e) Cautionary statements, if any, as required by law; and
(f) When applicable, and as determined by the Oregon Board of Pharmacy, an expiration date after which the patient should not use the drug.
(6) Prescription drugs shall be dispensed in containers complying with the federal Poison Prevention Packaging Act unless the patient requests a noncomplying container.
(7) Pharmacist and pharmacy personnel providing services to the ASC are subject to ORS chapter 689 and the rules thereunder.
Stat. Auth.: ORS 441.025
Stats. Implemented: ORS 441.025
Hist.: HD 11-1980, f. & ef. 9-10-80; HD 25-1983(Temp), f. & ef. 12-21-83; HD 23-1985, f. & ef. 10-11-85; Renumbered from 333-023-0163(1); HD 3-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0100(6); PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
333-076-0150
Emergency Services
The facility shall provide services, equipment and staff necessary to implement emergency medical care protocols.
Stat. Auth.: ORS 441.025
Stats. Implemented: ORS 441.025
Hist.: HD 11-1980, f. & ef. 9-10-80; HD 25-1983(Temp), f. & ef. 12-21-83; HD 23-1985, f. & ef. 10-11-85; Renumbered from 333-023-0163(1); HD 3-1990, f. 1-8-90, cert. ef. 1-15-90; Renumbered from 333-076-0100(7)(a) - (c)
333-076-0155
Laboratory Services
(1) Laboratory services shall be available for every patient either through the use of a licensed clinical laboratory in the facility or a written contract with a licensed clinical laboratory.
(2) Any tissue removed during surgery except those exempted under OAR 333-076-0165, shall be submitted for histological examination by a pathologist. A written report of findings shall be filed in the patient's record in accordance with 333-076-0165.
(3) OAR 333-024-0005 through 333-024-0350 shall also apply.
Stat. Auth.: ORS 441.025
Stats. Implemented: ORS 441.025
Hist.: HD 11-1980, f. & ef. 9-10-80; HD 25-1983(Temp), f. & ef. 12-21-83; HD 23-1985, f. & ef. 10-11-85; Renumbered from 333-023-0163(1); HD 3-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0100(8)(a) & (b); PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
333-076-0160
Care of Patients
(1) Each patient shall be evaluated for all risk factors before a surgical procedure may be performed in accordance with 42 CFR 416.42 and 416.52.
(2) Each patient shall be observed for post-operative complications under the direct supervision of a licensed registered nurse. Patients shall be observed for post-procedure complications until their conditions are stable.
(3) No medications or treatments shall be given without the order of a physician or other individual authorized within the scope of his/her license.
(4) At the time of discharge from the ASC, each patient must be evaluated by a physician, or by an anesthetist as defined by 45 CFR 410.69(b) for proper anesthesia recovery.
(5) Written instruction shall be given to patients on discharge covering signs and symptoms of complications as well as any necessary follow-up instructions for routine and/or emergency care.
(6) Each facility shall adopt and observe written patient care policies.
(7) Patient care policies shall be evaluated annually and rewritten as needed. Documentation of the evaluation is required.
Stat. Auth.: ORS 441.025
Stats. Implemented: ORS 441.025 & 441.086
Hist.: HD 11-1980, f. & ef. 9-10-80; HD 25-1983(Temp), f. & ef. 12-21-83; HD 23-1985, f. & ef. 10-11-85; Renumbered from 333-023-0163(1); HD 3-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0100(9)(a) - (e); PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
333-076-0165
Medical Records
(1) A medical record shall be maintained for every patient admitted for care.
(2) A legible reproducible medical record shall include at least the following (if applicable):
(a) Admitting identification data including date of admission;
(b) Chief complaint;
(c) Pertinent family and personal history;
(d) History and physical. This history and physical shall be completed no more than 30 days prior to the initiation of any procedure. Sufficient time shall be allowed between examination and the initiation of any procedure, to permit review of tests;
(e) Clinical laboratory reports as well as reports on any special examinations. (The original report shall be authenticated and recorded in the patient's medical record.);
(f) X-ray reports shall be recorded in the medical record and shall bear the identification (authentication) of the originator of the interpretation;
(g) Signed or authenticated report of consultant when such services have been obtained;
(h) All entries in patient's medical record must be dated, timed, and authenticated:
(A)Verification of an entry requires use of a unique identifier, i.e., signature, code, thumbprint, voice print or other means, which allows identification of the individual responsible for the entry;
(B) Verbal orders may be accepted by those individuals authorized by law and by medical staff rules and regulations and shall be countersigned or authenticated within two business days by the ordering health care practitioner or another health care practitioner who is responsible for the care of the patient;
(C) A single signature or authentication of the physician, dentist, podiatrist or other individual authorized within the scope of his or her professional license on the medical record does not suffice to cover the entire content of the record.
(i) Records of assessment and intervention, including but not limited to preprocedure vital sign records, graphic charts, medication records and appropriate personnel notes;
(j) Anesthesia record including records of anesthesia, analgesia and medications given in the course of the operation and postanesthetic condition, signed or authenticated by the person making the entry;
(k) A record of operation dictated or written immediately following surgery and including a complete description of the operation procedures and findings, postoperative diagnostic impression, and a description of the tissues and appliances, if any, removed;
(l) Postanesthesia Recovery (PAR) progress notes including but not limited to vital sign records and other appropriate clinical notes;
(m) Pathology report on tissues and appliances, if any, removed at the operation. The following tissues and appliances may be exempted from pathology exam:
(A) Specimens that, by their nature or condition, do not permit fruitful examination, including but not limited to a cataract, orthopedic appliance, foreign body, or portion of rib removed only to enhance operative exposure;
(B) Therapeutic radioactive sources, the removal of which shall be guided by radiation safety monitoring requirements;
(C) Traumatically injured members that have been amputated and for which examination for either medical or legal reasons is not deemed necessary;
(D) Specimens known to rarely, if ever, show pathological change, and the removal of which is highly visible postoperatively, including but not limited to the foreskin from circumcision of a newborn infant;
(E) Placentas that are grossly normal and have been removed in the course of operative and nonoperative obstetrics;
(F) Teeth, provided that the number, including fragments, is recorded in the medical record.
(n) Summary including final diagnosis;
(o) Date of discharge and discharge note;
(p) Autopsy report if applicable;
(q) Informed consent forms that document:
(A) The name of the ASC where the procedure or treatment was undertaken;
(B) The specific procedure or treatment for which consent was given;
(C) The name of the health care practitioner performing the procedure or administering the treatment;
(D) That the procedure or treatment, including the anticipated benefits, material risks, and alternatives was explained to the patient or the patient’s representative or why it would have been materially detrimental to the patient to do so, giving due consideration to the appropriate standards of practice of reasonable health care practitioners in the same or a similar community under the same or similar circumstances;
(E) The manner in which care will be provided in the event that complications occur that require health services beyond what the ASC has the capability to provide. If the ASC has entered into agreements with more than one hospital, the patient must be provided with the most likely possible option, but that the transfer hospital may be dependent on the type of problem encountered.
(F) The signature of the patient or the patient’s legal representative; and
(G) The date and time the informed consent was signed by the patient or the patient’s legal representative;
(r) Documentation of the disclosures required in ORS 441.098;
(s) Such signed documents as may be required by law.
(3) The completion of the medical record shall be the responsibility of the attending physician:
(a) Medical records shall be completed by the physician, dentist, podiatrist or other individual authorized within the scope of his or her professional license within four weeks following the patient's discharge;
(b) If a patient is transferred to another health care facility, transfer information shall accompany the patient. Transfer information shall include but not be limited to facility from which transferred, name of physician to assume care, date and time of discharge, current medical findings, current nursing assessment, current history and physical, diagnosis, orders from a physician for immediate care of the patient, operative report, if applicable; TB test, if applicable; other information germane to patient's condition. If discharge summary is not available at time of transfer, it shall be transmitted as soon as available.
(4) Diagnoses and operations shall be expressed in standard terminology.
(5) The medical records shall be filed in a manner which renders them easily retrievable. Medical records shall be protected against unauthorized access, fire, water and theft.
(6) Medical records are the property of the ASC. The medical record, either in original, electronic or microfilm form, shall not be removed from the institution except where necessary for a judicial or administrative proceeding. Authorized personnel of the Division shall be permitted to review medical records. When an ASC uses off-site storage for medical records, arrangements must be made for delivery of these records to the health care facility when needed for patient care or other health care facility activities. Precautions must be taken to protect patient confidentiality.
(7) All medical records shall be kept for a period of at least 10 years after the date of last discharge. Original medical records may be retained on paper, microfilm, electronic or other media.
(8) If an ASC changes ownership all medical records in original, electronic or microfilm form shall remain in the ASC or related institution, and it shall be the responsibility of the new owner to protect and maintain these records.
(9) If any ASC shall be finally closed, its medical records may be delivered and turned over to any other health care facility in the vicinity willing to accept and retain the same as provided in section (7) of this rule.
(10) All original clinical records or photographic or electronic facsimile thereof, not otherwise incorporated in the medical record, such as x-rays, electrocardiograms, electroencephalograms, and radiological isotope scans shall be retained for seven years after patient's last discharge if professional interpretations of such graphics are included in the medical records.
(11) A current written policy on the release of medical record information including patient access to his/her medical record shall be maintained in the facility.
(12) The Division may require the facility to obtain periodic and at least annual consultation from a qualified medical records consultant, RHIA/RHIT. The visits of the medical records consultant shall be of sufficient duration and frequency to review medical record systems and assure quality records of the patients. Contract for such services shall be available to the Division upon request.
Stat. Auth.: ORS 441.025
Stats. Implemented: ORS 441.025
Hist.: HD 3-1990, f. 1-8-90, cert. ef. 1-15-90; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
333-076-0170
Quality Assessment and Performance Improvement
(1) The governing body of an ASC must ensure that there is an effective, facility-wide quality assessment and performance improvement program that demonstrates measurable improvement in patient health outcomes, and improves patient safety by using quality indicators or performance measures associated with improved health outcomes and by the identification and reduction of medical errors.
(2) The ASC must measure, analyze, and track quality indicators, adverse patient events, infection control and other aspects of performance that includes care and services furnished in the ASC. Written documentation of quality assessment and performance improvement activities shall be recorded at least quarterly.
(3) After an analysis of the causes for adverse events, the ASC must develop and implement facility-wide preventive strategies and ensure that staff are trained in and familiar with these strategies.
(4) The ASC must set priorities for its performance improvement activities that:
(a) Focus on high risk, high volume and problem prone areas;
(b) Consider incidence, prevalence and severity of problems in those areas; and
(c) Affect health outcomes, patient safety and quality of care.
(5) An ASC already in operation and not certified by CMS on December 15, 2010 must be in compliance with this section by June 15, 2011.
Stat. Auth.: ORS 441.025
Stats. Implemented: ORS 441.025
Hist.: HD 3-1990, f. 1-8-90, cert. ef. 1-15-90; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
333-076-0175
Infection Control
(1) Each ASC shall establish and maintain an active facility-wide infection control program for the control and prevention of infection. The program shall be managed by a qualified individual and overseen by a multi-disciplinary committee which shall be responsible for investigating, controlling and preventing infections in the facility.
(2) Each ASC shall be responsible for developing written policies and for annual review of such policies, relating to at least the following:
(a) Identification of existing or potential infections in patients, employees, medical staff, and health care practitioners with ASC privileges;
(b) Control of factors affecting the transmission of infections and communicable diseases;
(c) Provisions for orienting and educating all employees, medical staff, health care practitioners with ASC privileges and volunteers on the cause, transmission, and prevention of infections;
(d) Collection, analysis, and use of data relating to infections in the ASC.
(3) Each ASC shall be responsible for the development, implementation and annual review of policies under section (2) of this rule.
(4) An ASC shall comply with all rules of the Division for the control of communicable diseases.
(5) Written isolation procedures in accordance with current Universal Precautions for Prevention of Transmission of HIV and Other Bloodborne Infections shall be established and followed by all ASC personnel for control and prevention of cross-infection. Guidelines can be obtained from U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Atlanta, GA 30333. Any guidelines published and distributed by the Division shall also be taken into consideration.
Stat. Auth.: ORS 441.025
Stats. Implemented: ORS 441.025
Hist.: HD 3-1990, f. 1-8-90, cert. ef. 1-15-90; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
333-076-0180
Inservice Training for Nurses
(1) Each year the inservice training agenda for nurses shall include at least the following:
(a) Infection control measures;
(b) Emergency procedures including, but not limited to, procedures for fire and other disaster;
(c) Procedures for life-threatening situations including, but not limited to, cardiopulmonary resuscitation and the life-saving techniques for choking victims; and
(d) Other special needs of the patient population.
(2) The facility shall assure that each licensed/certified employee is knowledgeable of the laws/rules governing his/her performance and that employees function within those performance standards.
(3) Documentation of such training shall include the date, content, duration and names of attendees.
Stat. Auth.: ORS 441.025
Stats. Implemented: ORS 441.025
Hist.: HD 3-1990, f. 1-8-90, cert. ef. 1-15-90; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
333-076-0185
Physical Environment
(1) Applicability. OAR 333-076-0185
shall apply to:
(a) An ambulatory surgical center
not licensed on April 1, 2012; or
(b) A major alteration to an
ambulatory surgical center for which plans were not submitted to the Division on
or before April 1, 2012; provided, however, that OAR 333-076-0185 shall apply only
to the major alteration and shall not apply to any other area of the ambulatory
surgical center.
(2) For the purpose of this
rule the following definitions apply:
(a) “Major alteration”
means any structural change to the foundation, floor, roof, or exterior or load
bearing wall of a building, or the extension of an existing building to increase
its floor area, where such structural change or extension affects patient care or
safety. “Major alteration” also means the modification of an existing
building that results in a change in use, even if the modification does not include
any structural change to the building, where such modification affects patient care
or safety. “Major alteration” does not include cosmetic upgrades to
the interior or exterior of an existing building, including but not limited to changes
to wall finishes, floor coverings and casework.
(b) “Change in use”
means altering the purpose of an existing room. “Change in use” does
not include the sale of an ASC if the new owner provides services in the same class
of operating rooms pursuant to section (15) of this rule.
(3) Notification of Alteration:
If an ASC proposes any of the following alterations the ASC must notify the Division.
The Division shall determine, on a case-by-case basis, whether such alterations
constitute a “change in use”. If an alteration affects patient care,
patient safety, is a change of use, or includes any of the following, the alteration
is subject to this rule:
(a) Addition of surgical services,
to the extent the additional surgical services can not be performed in the class
of operating rooms existing in the ASC pursuant to section (15) of this rule;
(b) Replacement of equipment
in the ASC that is permanently connected to major building components, such as:
power, heating, ventilation, air conditioning, plumbing or medical gas; and
(c) Addition of doors to pre-operative
holding areas or post-anesthesia care units.
(4) Functional Program.
(a) An ASC shall provide a description
of its functional program when plans are submitted for review, along with additional
requirements found in OAR 333-675-0000.
(b) The functional program describes
in detail the purpose of the project, department relationships and flow of patients,
staff, visitors and supplies as applicable, size and function of each space, description
of those services necessary for the complete operation of the ASC, type of anesthesia
used, average recovery time, special design feature(s), occupant load, numbers of
staff and patients, visitors and vendors, issue of privacy/confidentiality for patients,
level of medical gas system per NFPA 99, and type of central electrical system.
(5) Location. Building entrances
used to reach outpatient services shall be at grade level, clearly marked, and located
so patients need not go through other activity areas. Travel patterns shall preclude
unrelated traffic within the unit.
(6) Mixed Uses. An ASC is a
distinct entity and must be separate and distinguishable from any other health care
facility or office-based physician practice, but the ASC may share a reception area,
waiting room and public toilet rooms with the other health care facility or office-based
physician practice. Medicare-certified ASCs are subject to specific requirements
related to sharing spaces with another health care facility or office-based physician
practice. An ASC that is Medicare-certified must be distinct from any other health
care facility or office-based physician practice as required in 42 CFR 416.2 and
42 CFR 416.44(a)(2) and (b).
(7) Conformance to Building
and Fire and Life Safety Codes. ASCs shall conform to the editions of the Oregon
State Building Code, as defined in ORS 455.010(8), under which they were constructed.
ASCs to be certified for Medicare reimbursement shall meet standards of the National
Fire Protection Association (NFPA) #101 and #99 Codes.
(8) Administrative and Public
Areas. An ASC shall have:
(a) An entrance sheltered from
inclement weather and accessible to the disabled. If a separate door is provided
for the discharge of patients, it must be sheltered from inclement weather and shall
be accessible to the disabled;
(b) A reception counter or desk;
(c) Toilet(s) for public use
conveniently accessible from the waiting area without passing through patient care
or staff work areas or suites;
(d) Telephone access for local
phone calls for patients;
(e) Conveniently accessible
drinking water;
(f) Conveniently accessible
wheelchair storage;
(g) Space(s) for private interviews
relating to financing and credit discussions;
(h) Space for business transactions,
records storage and administrative and professional staff to work, including but
not limited to space designated for computers, printers, fax machines, and copiers
if required by the functional program;
(i) Secure and safe storage
for medical records of all media type, located to maintain the confidentiality of
records and either restricted to staff
movement or remote from treatment and public areas. Space required shall be defined
by the functional program;
(j) Special storage for staff personal
effects with locking drawers or cabinets; and
(k) General storage for supplies
and equipment as identified in the functional program.
(9) Environmental Services Room
(Housekeeping Closet). An ASC shall have an environmental services room that contains
a floor receptor or service sink and storage space for housekeeping supplies and
equipment, and that is at least 16 square feet.
(10) Layout. An ASC shall provide
three areas — unrestricted, semi-restricted, and restricted — that are
defined by the physical activities performed in each area.
(a) Unrestricted area. For the
purpose of this rule, unrestricted areas shall include a central control point established
to monitor the entrance of patients, personnel, and materials into the restricted
areas. (Street clothes are permitted in this area, and traffic is not limited.)
(b) Semi-restricted area. For
the purpose of this rule, semi-restricted areas shall include the peripheral support
areas of the surgical suite, where traffic is limited to authorized personnel and
patients, and where personnel are required to wear surgical attire and hair coverings.
A semi-restricted area includes but is not limited to:
(A) Storage areas for clean
and sterile supplies;
(B) Work areas for storage and
processing of instruments;
(C) Corridors leading to the
restricted areas of the surgical suite; and
(D) Scrub sink areas.
(c) Restricted area. For the
purpose of this rule, restricted areas are areas where surgical attire and hair
coverings are required, and where masks are required due to the presence of open
sterile supplies or scrubbed people. A restricted area includes but is not limited
to:
(A) Operating and other procedure
rooms; and
(B) The clean core (if required
by the functional program).
(d) Signs shall be provided
at all entrances to restricted areas indicating surgical attire required.
(11) Special Patient Care Rooms.
In ASCs with a functional program that includes treatment of patients with known
infectious disease or populations with known compromised or suppressed immune systems,
the need for and number of airborne infection isolation rooms and protective environment
rooms shall be determined by an infection control risk assessment (ICRA).
(a) Airborne Infection Isolation
(AII) Room. For the purpose of this rule, Airborne Infection Isolation refers to
the isolation of patients infected with organisms spread by airborne droplet nuclei
and shall have:
(A) Only one bed and a hand-washing
station (placement of an additional hand-washing station outside the room entrance
shall be permitted);
(B) An area for gowning and
storage of clean and soiled materials located either directly outside or inside
the entry door to the patient room;
(C) A separate room with a toilet
and hand-washing station;
(D) Perimeter walls, a ceiling,
and floor, including penetrations, that are sealed tightly so that air does not
infiltrate the environment from the outside or from other spaces;
(E) Self-closing devices on
all room exit doors;
(F) Doors with edge seals;
(G) Window treatments and privacy
curtains:
(i) Window treatments and privacy
curtains shall be smooth-surfaced, easy-to-clean, wipeable, and non-pleated;
(ii) Fabric drapes and curtains
shall not be used for window treatments;
(iii) Use of fabric privacy
curtains shall be permitted if they are washable. A wipeable fabric with a smooth
surface is preferable.
(b) Anteroom. An anteroom to
a patient isolation room is not required; however, if an anteroom is part of the
design concept, it shall meet the following requirements:
(A) Space for persons to don
personal protective equipment before entering the patient room; and
(B) Doors with self-closing
devices.
(c) Protective Environment (PE)
Rooms. For the purpose of this rule, Protective Environment Room refers to a patient
room that is designed to protect a high risk, immunocompromised patient from human
and environmental airborne pathogens.
(A) When determined by an Infection
Control Risk Assessment (ICRA) and the functional program, special design considerations
and ventilation shall be required to ensure the protection of patients who are highly
susceptible to infection; and
(B) The room(s) shall meet the
requirements of subsection (11)(a) except for paragraph (C).
(12) Non-invasive Procedure
& Consultation Room. A non-invasive procedure and consultation room is not a
"procedure room" for purposes of ORS 441.020. A non-invasive procedure and consultation
room shall have:
(a) A minimum clear floor area
of 120 square feet with a minimum room dimension of 10 feet;
(b) A room arrangement that
permits a minimum clear dimension of 3 feet at each side and at the foot of the
bed;
(c) A hand-washing station;
(d) A counter or shelf space
for writing or electronic documentation; and
(e) Visual and acoustical privacy
for private medical consultations and confidential communication with patients and
their families/legal guardians.
(13) Sterilization Facilities:
An ASC shall have space and a system for sterilizing equipment and supplies either
on-site or off-site. If located on site, sterilization facilities shall be located
in a semi-restricted area and shall include a separate area for cleaning and decontamination
of instruments prior to sterilization. Sterilization facilities shall include, but
are not limited to, a high-speed sterilizer or other sterilizing equipment for immediate
or emergency use, as required by the functional program.
(a) When sterilization is provided
off-site, a room for the adequate handling (receiving and distribution) and on-site
storage of sterile supplies, that meet paragraph (13)(c)(C) of this rule shall be
provided.
(b) Provisions shall be made
for sanitizing clean and soiled carts or vehicles consistent with the needs of the
particular transportation system.
(c) An on-site processing facility
shall include:
(A) A decontamination room for
the exclusive use of the surgical suite. If the room has a door or pass through
opening for decontaminated instruments between the decontamination room and a clean
workroom it shall have a self closing door, but it may not have a direct connection
with an operating room. A decontamination room shall include:
(i) A flushing-rim clinical
sink or equivalent flush-rim fixture unless the decontamination room is used only
for temporary holding of soiled material;
(ii) A hand-washing station;
and
(iii) A work counter unless
the decontamination room is used only for temporary holding of soiled material.
(B) A clean assembly/workroom
that is physically separated from soiled work areas that has adequate space for
the designated number of work areas as defined in the functional program as well
as space for storage of clean supplies, sterilizer carriages (if used), and instrumentation.
Access to this area shall be restricted. A clean/assembly workroom shall contain:
(i) A hand-washing station;
(ii) Workspace; and
(iii) Equipment for terminal
sterilizing of medical and surgical equipment and supplies.
(C) Storage for sterile supplies
and packs, including provisions for ventilation, humidity, and temperature control.
(i) The sterile supply storage
area shall have a floor area as required per the functional program.
(ii) As described in paragraph
(13)(c)(B) of this rule, location of the sterile supply storage in an area within
the clean assembly/workroom shall
be permitted if it is a permanently designated area.
(14) Linen Services. Designated space in
the post-anesthesia recovery area(s) shall be provided for clean and soiled linen.
(a) On-site Processing Area.
If the functional program requires linen to be processed on site, the area shall:
(A) Be large enough to accommodate
a washer, a dryer, and any plumbing equipment needed to meet the temperature requirements
of 160 degrees;
(B) Be divided into distinct
soiled (sort and wash) and clean (dry and fold) areas;
(C) Have storage for laundry
supplies and clean linen; and
(D) Have a hand-washing station
within 10 feet without passing through a door.
(b) Off-site Laundry Service
Areas. If the functional program requires linen to be processed off site, the area
within the ASC shall have a:
(A) Soiled linen holding area
or designated and dedicated area for a soiled laundry cart; and
(B) Clean linen storage area
that protects linen from soil or damage.
(15) Operating Rooms. The size
and location of the operating rooms shall depend on the level of care and equipment
specified in the functional program.
(a) Class A Operating Room.
For the purpose of this rule, a Class A operating room is for surgery and other
procedures that require minimal sedation including but not limited to minor surgical
procedures performed under topical and local infiltration blocks with or without
oral or intramuscular preoperative sedation. A surgical procedure performed in a
Class A operating room could also be performed in a Class B or C operating room.
(A) Space requirements. Class
A operating rooms shall have a minimum clear floor area of 150 square feet within
a minimum clear dimension of 12 feet.
(B) Clearances. There shall
be a minimum clear distance of 3 feet 6 inches at each side, the head, and the foot
of the operating table.
(C) Location. Class A operating
rooms may be accessed from the semi-restricted corridors of the surgical suite or
from an unrestricted corridor adjacent to the surgical suite.
(b) Class B Operating Room.
For the purposes of this rule a Class B operating room is for surgery and other
procedures that require conscious sedation. A procedure performed in a Class B operating
room could also be performed in a Class C operating room.
(A) Space requirements. Class
B operating rooms shall have a minimum clear floor area of 250 square feet with
a minimum clear dimension of 15 feet.
(B) Clearances. Room arrangement
shall permit a minimum clear dimension of 3 feet 6 inches at each side, the head,
and the foot of the operating table.
(C) Location. Class B operating
rooms shall be accessed from the semi-restricted corridors of the surgical suite.
(c) Class C Operating Room.
For the purpose of this rule a Class C operating room is for surgery and procedures
that require general anesthesia or deep sedation.
(A) Space requirements. Class
C operating rooms shall have a minimum clear floor area of 400 square feet and a
minimum clear dimension of 18 feet.
(B) Clearances. Room arrangement
shall permit a minimum clear dimension of 4 feet at each side, the head, and the
foot of the operating table.
(C) Location. Class C operating
rooms shall be accessed from the semi-restricted corridors of the surgical suite.
(d) Each operating room shall
have access to at least one medical image viewer located as required by the functional
program.
(e) All operating rooms shall
be equipped with an emergency communication system designed and installed to effectively
summon additional qualified staff support with no more than push activation of an
emergency call switch.
(f) An operating room is considered
a procedure room for the purposes of determining the appropriate fee under ORS 441.020.
(16) Pre-operative Support Areas.
(a) Location. Pre-operative
holding areas shall be under direct visual control of the nursing staff. Pre-operative
holding can be shared with post-operative if the functional program defines patient
management.
(A) For a Class A operating
room the minimum number of patient stations within the pre-operative holding areas
is as follows:
(i) At least one patient station
if the operating room is accessed from the semi-restricted area.
(ii) None if the operating room
is accessed from an unrestricted area and the functional program allows for pre-operative
care to be carried out in the operating room.
(B) For a Class B operating
room, at least one patient station within the pre-operative holding areas is required.
A patient station may consist of a bed, chair or stretcher.
(C) For Class C operating room,
at least one patient station per Class C operating room is required.
(D) In an ASC with Class B and
Class C operating rooms, area shall be provided to accommodate stretcher and chair
space.
(b) Area. Each pre-operative
holding area shall provide a minimum clear floor area of 80 square feet for each
patient station.
(c) Clearances. Each pre-operative
holding area shall have a minimum clear dimension of 5 feet between patient and
4 feet between patient and adjacent walls (at the stretcher’s or chair’s
side and foot).
(d) Patient privacy. Provisions
such as cubicle curtains shall be made for patient privacy.
(e) Hand-washing station. Hands-free
or wrist blade-operable controls shall be available, with at least one station for
every six positions or fewer and for each major fraction thereof. Hand-washing stations
shall be uniformly distributed to provide convenient access from each patient position.
Travel distance to a hand-washing station shall not exceed 20 feet, and shall be
located without passing through a door. Travel distances shall be calculated from
the foot of the patient station to the hand-washing station.
(f) Documentation space. A counter,
table, area for a desk, or storage for a movable table shall be provided.
(g) Change Area. A separate
area(s) shall be provided for outpatients to change from street clothing to hospital
gowns and prepare for surgery. If the ASC has four or fewer operating rooms, the
change area can also be a holding area(s). The change area shall include the following:
(A) Lockers, or acceptable provisions
made for securing patients’ personal effects; and
(B) Toilet(s). The patient toilet
room(s) shall be separate from public use toilet(s) and located to permit access
from pre- and post-operative holding areas.
(17) Recovery Areas.
(a) When determining the number
of recovery positions required, an ASC shall take into consideration the types of
surgery and procedures performed in the ASC, the types of anesthesia used, average
recovery periods, and anticipated staffing levels.
(b) Recovery areas shall be
accessible directly from the semi-restricted area. If pre-operative holding areas,
Phase 2 areas and recovery areas are required per the functional program, these
spaces may be shared if the number of patient positions meet the most restrictive
requirements of both pre and post operative areas.
(c) Nurse Control Station. The
nurse control station shall have direct sightline to patients in acute recovery
stations.
(d) If pediatric surgery is
practiced, the functional program and physical environment design shall address
the following:
(A) Locations of pediatric recovery
stations;
(B) Space for parents;
(C) Sound attenuation; and
(D) Proximity of patient stations
to a nursing station.
(e)(A) Post-anesthesia
recovery positions. Room(s) for post-anesthesia recovery in an ASC shall be provided
in accordance with the functional program;
(B) Number. A minimum of one recovery station
per operating room shall be provided. A recovery area analysis shall determine the
need for additional recovery stations. In the absence of a recovery area analysis
approved by the Division, the minimum number of post-anesthesia recovery positions
shall be as follows:
(i) Three recovery positions
for each Class C operating room;
(ii) Two recovery positions
for each Class B operating room;
(iii) One recovery position
for each Class A operating room.
(f) Area. When a patient cubicle
is used for each patient care station, a minimum clear floor area of 80 square feet
shall be provided. Space shall also be provided for additional equipment described
in the functional program.
(g) Clearances. Each post-anesthesia
recovery area shall provide a minimum clear dimension of 5 feet between patient
stretchers or beds, 4 feet between patient stretchers or beds and adjacent walls
(at the stretcher’s sides and foot), and at least 3 feet from the foot of
the stretcher or bed to the closed cubicle curtain.
(h) Patient privacy. Provisions
for patient privacy such as cubicle curtains shall be made.
(i) Hand-washing station. Hands-free
or wrist blade-operable controls shall be available, with at least one station for
every six positions or fewer and for each major fraction thereof. Hand-washing stations
shall be uniformly distributed to provide convenient access from each patient position.
Travel distance to a hand-washing station shall not exceed 20 feet, and shall be
located without passing through a door. Travel distances shall be calculated from
the foot of the patient station to the hand-washing station.
(j) Patient toilet room(s).
In an ASC with three or more operating rooms, a dedicated patient toilet room shall
be provided in the recovery area.
(k) Support areas for post-anesthesia
recovery rooms. If the post-anesthesia recovery room(s) is located immediately adjacent
to the surgical suite, sharing of these support areas shall be permitted;
(A) Supply storage. Storage
space shall be determined by the functional program, however, at least 15 cubic
feet needs to be provided.
(B) Receptacles for soiled linen
and waste holding shall be provided and meet the requirements of NFPA 101, 20.7.5.5.
(C) Documentation space. A counter,
table, area for a desk, or storage for a movable table shall be provided.
(D) Drug distribution station.
Each recovery area shall have a drug distribution station that includes:
(i) An area for the storage
and preparation of medications administered to patients;
(ii) A refrigerator for pharmaceuticals
and double-locked storage for controlled substances if required by the functional
program; and
(iii) Convenient access to a
hand-washing station without passing through a door.
(E) Nourishment facilities within
a recovery area shall have:
(i) A sink, work counter, refrigerator,
storage cabinets, and equipment for serving nourishment as required by the functional
program; and
(ii) A hand-washing station
that is located in the nourishment area or adjacent to the nourishment area.
(18) Phase 2 Recovery.
(a) A Phase 2 recovery area
shall be provided if required by the functional program.
(b) Location of the Phase 2
recovery area within the post-anesthesia recovery area shall be permitted, but the
Phase 2 area shall be an identifiably separate and distinct part of the post-anesthesia
recovery area. Phase 2 recovery stations can be shared with recovery stations if
the functional program defines patient management.
(c) Area. When a patient cubicle
is used for each patient care station, the design shall provide a minimum of 50
square feet for each patient in a lounge chair with space for additional equipment
described in the functional program.
(d) Clearances.
(A) The design shall provide
a minimum clear dimension of 4 feet between the sides of adjacent lounge chairs
and between the foot of the lounge chairs and the nearest obstruction.
(B) When permanent partitions
(full or partial height or width) are used to partially define the patient care
station (rather than cubicle curtains), a minimum clear dimension of 3 feet shall
be provided on the side of the lounge chair.
(e) Patient privacy. Provisions
for patient visual privacy such as cubicle curtains shall be made.
(f) Hand-washing station. Hands-free
or wrist blade-operable controls shall be available, with at least one station for
every six positions or fewer and for each major fraction thereof. Hand-washing stations
shall be uniformly distributed to provide convenient access from each patient position.
Travel distance to a hand-washing station shall not exceed 20 feet, and shall be
located without passing through a door. Travel distances shall be calculated from
the foot of the patient station to the hand-washing station;
(g) Patient toilet room(s).
In an ASC with two or fewer operating rooms, a patient toilet room shall be provided
in or adjacent to the Phase 2 recovery area. In an ASC with three or more operating
rooms, a patient toilet room shall be provided in the Phase 2 recovery area.
(h) Support areas for Phase
2 recovery (if provided) shall provide the following:
(A) Clear sightlines and easy
access from the post-anesthesia recovery area to the nurse control station;
(B) Storage space for supplies
and equipment;
(C) Documentation space. A counter,
table, area for a desk, or storage for a movable table; and
(D) Space for family members.
(19) Support for the Surgical
Service Areas: The following shall be provided in the surgical service areas:
(a) Visual surveillance by nursing
staff of all traffic entering the semi-restricted corridor (the passage used to
access operating rooms and ancillary semi-restricted areas) per the functional program;
(b) Medication storage. Drug
storage shall be provided. A refrigerator for pharmaceuticals and double-locked
storage for controlled substances shall be provided if required by the functional
program;
(c) Scrub facilities. With the
exception of ASCs providing exclusively gastrointestinal endoscopy services, an
ASC shall have a scrub station(s) trimmed with foot, knee, or electronic controls.
Single-lever wrist blades shall not be permitted. Scrub station(s) shall be provided
at the entrance to each operating room. A scrub station may serve two operating
rooms if it is located on the same wall, and between the two entrances. Scrub stations
shall be arranged to minimize splatter on nearby personnel or supply carts. A dedicated
hand wash station with hands-free controls shall be provided in each room used for
gastrointestinal endoscopy services.
(d) Equipment and supply storage.
Equipment storage room(s) shall be provided for equipment and supplies used in the
surgical service areas. The combined area of equipment and clean clinical supply
storage room(s) shall have a minimum floor area of 50 square feet for each operating
room(s) up to two and an additional 25 square feet per additional operating room.
Equipment storage room(s) shall be located within the semi-restricted area;
(e) Anesthesia supply storage.
An area shall be provided for storing anesthesia equipment and supplies, as defined
by the functional program. This space shall be located within the semi-restricted
area;
(f) Medical gas storage. An
area shall be provided for the storage of medical gas(es) used in the ASC, including
adequate space for reserve cylinders. Such space shall meet National Fire Protection
Association 99 standards;
(g) Stretcher storage area.
In an ASC that provides Class B and C operating rooms, a stretcher storage area
for at least one stretcher shall be
provided. This storage area shall be convenient for use and located outside the
required width of the exit access corridor;
(h) Staff lounge and toilet facilities.
Staff lounge toilet facilities shall be provided in an ASC with three or more operating
rooms. The toilet room shall be near the recovery area;
(i) Staff lockers. Appropriate
change area(s) shall be provided for male and female staff working within the surgical
suite (a unisex locker area with one or more private changing rooms shall be permitted.)
For an ASC that provides services in Class B and C operating rooms, this area(s)
shall be designed to effect a one-way traffic pattern so that personnel entering
from outside the surgical suite can change and move directly into the suite’s
semi-restricted corridor. As least one staff shower shall be provided that is conveniently
accessible to the surgical suite and recovery areas;
(j) Environmental services room
(housekeeping closet). An environmental services room shall be provided exclusively
for the surgical suite. This room shall contain a floor receptor or service sink
and storage space for housekeeping supplies and equipment and shall be at least
16 square feet;
(k) Emergency equipment/supply
storage. Provisions shall be made for access to and use of emergency resuscitation
equipment and supplies (crash cart(s) and anesthesia carts) within 60 feet and at
least one per floor of patient care areas;
(l) Fluid waste disposal. Fluid
waste disposal facilities shall be provided and shall be located so that they are
convenient to the operating rooms and recovery areas. A clinical sink or equivalent
equipment in a soiled workroom shall meet this requirement in the operating room
area, and a toilet equipped with a bedpan-cleaning device or a separate clinical
sink shall meet the requirement in the recovery area.
(20) Details and Finishes:
(a) Corridor width. Public corridors
shall have a minimum width of 5 feet, except that corridors connecting the operating
room section and the post anesthesia care unit and at least one ambulance transfer
exit, where patients are transported on stretchers or beds, shall have a minimum
width of 6 feet. The semi-restricted corridor shall have a minimum width of 8 feet
in areas used to transport patients on gurneys between pre-operative, procedure,
and post-anesthesia recovery areas. Passages and corridors used exclusively for
staff access shall be a minimum of 3 feet 8 inches in clear width. Items such as
provisions for drinking water, telephone booths, vending machines, etc., shall not
restrict corridor traffic or reduce the corridor width below the required minimum.
In-corridor storage or parking space for portable equipment shall not overlap required
corridor widths. Width shall also meet OFC 1018.2.
(b) Doors and door hardware.
The minimum door width for patient use shall be 3 feet. Door openings requiring
gurney/stretcher access shall have a minimum clear width of 3 feet 8 inches;
(c) Hand-washing stations. Hand
sanitation dispensers shall be provided in addition to hand-washing stations. The
number and location of both hand-washing stations and hand sanitation dispensers
shall be determined by ICRA;
(A) Hand-washing stations used
by medical and nursing staff, patients, and food handlers shall be trimmed with
valves that can be operated without hands. Single-lever or wrist blade devices shall
be permitted. Sensor-regulated water fixtures shall meet user need for temperature
and length of time the water flows. Electronic faucets shall be capable of functioning
during loss of normal power. Knee control, foot pedal, electronic or other devices
that allow operation without use of the hands are acceptable.
(B) Sinks in hand-washing stations
shall be designed with deep basins to prevent splashing to areas where direct patient
care is provided, particularly those surfaces where sterile procedures are performed
and medications are prepared.
(C) The area of the basin shall
not be less than 144 square inches with a minimum 9 inch width or length.
(d) Clinical sinks.
(A) Handles on clinical sinks
shall be at least 6 inches long.
(B) Clinical sinks shall have
an integral trap wherein the upper portion of the water trap provides a visible
seal.
(e) Provisions for hand drying
shall be required at all hand-washing stations except scrub sinks.
(A) Hand-washing stations shall
include a hand-drying device that does not require hands to contact the dispenser.
(B) If provided, hand towels
shall be directly accessible to sinks.
(f) Cleansing agents. Hand-washing
stations shall include liquid or foam soap dispensers.
(g) Toilet rooms for patient
use in surgery and recovery areas shall be equipped with doors and hardware that
permit access from the outside in emergencies. When such rooms have only one opening,
the doors shall open outward or be otherwise designed to open without pressing against
a patient who may have collapsed within the room.
(h) Radiation protection requirements
for X-ray and gamma ray installations shall conform with National Council on Radiation
Protection and Measurements (NCRP) reports 102, 147, and 151 and all applicable
state requirements. Testing is to be coordinated with the Division’s Radiation
Protection Services program to prevent duplication of test observations or construction
inspections. Provision shall be made for testing completed installations before
use. All defects shall be corrected before approval.
(i) The minimum ceiling height
of an ASC shall be 7 feet 10 inches, with the following exceptions:
(A) Ceiling height in corridors,
storage rooms, toilet rooms, and other minor rooms shall not be less than 7 feet
8 inches;
(B) Radiographic and other rooms
containing ceiling-mounted equipment shall have ceilings of sufficient height to
accommodate the equipment and fixtures; and
(C) Boiler rooms shall have
ceiling clearances not less than 2 feet 6 inches above the main boiler header and
connecting pipe.
(j) Ceilings. Ceiling finishes
shall be appropriate for the areas in which they are located and shall be as follows:
(A) Semi-restricted areas.
(i) Ceiling finishes in semi-restricted
areas such as clean corridors, central sterile supply spaces, specialized radiographic
rooms, and Class A operating rooms shall be smooth, scrubbable, nonabsorptive, nonperforated,
capable of withstanding cleaning with chemicals, and without crevices that can harbor
mold and bacteria growth.
(ii) Perforated, tegular, serrated,
or highly textured tiles shall not be used.
(B) Restricted areas.
(i) Ceilings in restricted areas
such as operating rooms shall be monolithic, scrubbable, and capable of withstanding
chemicals. Cracks or perforations in these ceilings are not allowed.
(ii) All access openings in
ceilings in restricted areas shall be gasketed.
(C) Mechanical and electrical
rooms. Suspended ceilings may be omitted in mechanical and electrical rooms/spaces
unless required for fire safety purposes.
(k) Floor finishes shall be
appropriate for the areas in which they are located and shall:
(A) Be easy to maintain, readily
cleanable and appropriately wear-resistant;
(B) In all areas such as clean
corridors, central sterile supply spaces, specialized radiographic rooms, and Class
A operating rooms, be washable, smooth and able to withstand chemical cleaning;
(C) In areas such as operating
rooms, environmental services rooms, and soiled holding or utility rooms, be scrubbable,
able to withstand chemical cleaning, and monolithic, with an integral base of at
least 6 inches;
(D) In clinical areas, be constructed
of materials that allow the easy movement of all required wheeled equipment;
(E) Provide smooth transitions
between different flooring materials;
(F) Allow for ease of ambulation
and self-propulsion. Carpet and carpet with padding in patient areas shall be glued
down or stretched taut and free of
loose edges or wrinkles that might create hazards or interfere with the operation
of lifts, wheelchairs, walkers, wheeled carts, or patients utilizing orthotic devices;
(G) In all areas subject to wet cleaning
methods, not be physically affected by germicidal or other types of cleaning solutions;
(H) Be slip-resistant for flooring
surfaces in wet areas (e.g., kitchens, showers and baths), ramps, entries from exterior
to interior space, and areas that include water for patient services; and
(I) Joints for flooring openings
for pipes, ducts, and conduits shall be tightly sealed to minimize entry of pests.
Joints of structural elements shall be similarly sealed.
(l) Wall finishes shall be cleanable
and washable. In the vicinity of plumbing fixtures, wall finishes shall be smooth
and moisture resistant.
(A) Wall finishes in areas such
as clean corridors, central sterile supply spaces, specialized radiographic rooms,
and minor surgical procedure rooms shall be washable, smooth, and able to withstand
chemical cleaning.
(B) Wall finishes in areas such
as operating rooms, delivery rooms, and trauma rooms shall be scrubbable, able to
withstand chemical cleaning, and monolithic.
(C) Wall finish treatments shall
not create ledges or crevices that can harbor dust and dirt.
(D) Wall surfaces in wet areas
(e.g. environmental services rooms) shall be monolithic and all seams shall be covered
or sealed.
(E) Wall bases in areas routinely
subjected to wet cleaning shall be monolithic and coved with the floor, tightly
sealed to the wall, and constructed without voids.
(F) Wall areas penetrated by
pipes, ducts, and conduits shall be tightly sealed to minimize the entry of rodents
and insects. Joints of structural elements shall be similarly sealed.
(G) Sharp, protruding corners
shall be avoided.
(H) Wall protection devices
and corner guards shall be durable and scrubbable.
(21) Elevators. Electric or
hydraulic elevators are required if the ASC has patient spaces located on other
than the grade-level entrance floor. The elevator shall be sized to accept a gurney
or stretcher plus an attendant.
(a) Dimensions. Cars shall have
a minimum inside floor dimension of not less than 5 feet.
(b) Leveling device. Elevators
shall be equipped with a two-way automatic level-maintaining device with an accuracy
of ±one-half inch.
(c) Elevator controls:
(A) Elevator call buttons and
controls shall not be activated by heat or smoke. Light beams, if used for operating
door reopening devices without touch, shall be used in combination with door-edge
safety devices and shall be interconnected with a system of smoke detectors so the
light control feature will be overridden or disengaged should it encounter smoke
at any landing.
(B) Elevator controls, alarm
buttons, and telephones shall be accessible to wheelchair occupants and usable by
the blind.
(d) Emergency power must comply
with NFPA 99 requirements.
(22) Mechanical system design.
(a) In new construction, the
mechanical system shall be designed and constructed for overall efficiency in accord
with the Oregon Mechanical Specialty Code and the Oregon Energy Efficiency
Specialty Code, as enforced by the Oregon Building Codes Division or local jurisdictions
having authority.
(b) Efficiency. The mechanical
system shall be designed for overall efficiency and appropriate life-cycle cost.
(c) Use of recognized energy-saving
mechanisms such as variable-air-volume (VAV) systems, load shedding, programmed
controls for unoccupied periods (nights and weekends, etc.), and use of natural
ventilation may be considered.
(d) Air-handling systems shall
be designed with an economizer cycle where appropriate to use outside air.
(e) VAV systems. The energy-saving
potential of VAV systems is recognized, and the standards herein are intended to
maximize appropriate use of such systems. Any system used for occupied areas shall
include provisions to avoid air stagnation in interior spaces where thermostat demands
are met by temperatures of surrounding areas. Reference Table 1 contains minimum
ventilation and airflow requirements.
(f) Recirculating rooms units
(such as induction unit and unit ventilators) may be used in individual rooms for
heating and cooling purposes except as noted in Table 1. Outdoor air requirements
shall be met by separate air handling systems with proper filtration. Reference
Table 2 contains the filtration requirements.
(g) Vibration isolators. Mechanical
equipment, ductwork, and piping shall be mounted on vibration isolators.
(h) System valves. Supply and
return mains and risers for cooling, heating, and steam systems shall be equipped
with valves to isolate the various sections of each system. Each piece of equipment
shall have valves at the supply and return ends.
(i) Testing and documentation.
(A) Prior to licensure of an
ASC, all systems shall be tested and operated to demonstrate to the owner or its
designated representative that the installation and performance of these systems
conform to design intent. Test results shall be documented for maintenance files.
(B) Upon completion of the installation,
the owner of an ASC shall ensure that a complete set of manufacturer’s operating,
maintenance, and preventive maintenance instructions; a parts list; and complete
procurement information, including equipment numbers and descriptions, has been
obtained.
(C) An ASC shall ensure that
staff who operate the systems shall be provided with instructions for proper operation
of systems and equipment. Required information shall include all safety or code
ratings as needed.
(23) Ventilation and space-conditioning
requirements. All rooms and areas used for patient care shall have ventilation per
Table 1. Although natural ventilation shall be permitted, mechanical ventilation
shall be provided in all patient care rooms and areas in an ASC.
(24) HVAC Requirements for Specific
Locations.
(a) Airborne infection isolation
(AII) rooms. These special ventilation areas have an inward air movement relationship
to adjacent areas where a patient with airborne infectious diseases may be a risk
to the surrounding area. If AII rooms are required per the functional program, the
HVAC design must meet the requirements of OAR 333-535-0300.
(b) Protective environment (PE)
rooms. These special ventilation areas have an outward air movement relationship
to adjacent areas where the patient may be at risk from the surrounding areas. If
PE rooms are provided per the functional program, the PE rooms must meet the requirements
of OAR 333-535-0300.
(c) Operating rooms.
(A) Air distribution.
(i) Operating room air supply
shall be from ceiling outlets near the center of the work area for effective air
movement control. Laminar flow design diffusers shall be used in Class B and C operating
rooms as required by the functional program.
(ii) Each operating room shall
have a minimum of two air inlets located as remotely from each other as possible.
The return air inlets shall be located near the floor level in Class B and C operating
rooms.
(B) Ventilation rates.
(i) The ventilation systems
for Class B and C operating rooms shall operate at all times, except during maintenance
and conditions requiring shutdown by the building’s fire alarm system.
(ii) During unoccupied hours,
operating room air change rates may be reduced, provided that the positive room
pressure is maintained as required and the required air changes are automatically
re-established any time the space is being utilized.
(iii) Ventilation systems serving
Class A Operating Rooms and Class B Operating Rooms used for Endoscopy may be shut
off during unoccupied periods if these areas will not have an inward air pressure
relationship to adjacent areas.
(C)
Humidity and smoke venting requirements in anesthetizing locations shall be designed
per NFPA 99.
(d) Anesthesia storage rooms. The ventilation
systems for inhalation anesthesia storage rooms shall conform to the requirements
for medical gas storage as described in NFPA 99.
(e) ETO sterilizer space. The
space that houses ethylene oxide (ETO) sterilizers shall be designed per OAR 333-535-0300.
(25) Thermal Insulation and
Acoustical Provisions. Insulation shall be provided within the building to conserve
energy, protect personnel, prevent vapor condensation, and reduce noise.
(a) Renovation.
(A) Existing accessible insulation
within areas of ASCs to be modernized shall be inspected, then repaired, or replaced,
as determined by inspection.
(B) If existing lined ductwork
is reworked in a renovation project, the liner seams and punctures shall be resealed.
(b) Duct linings exposed to
air movement shall not be used in ducts serving operating rooms, recovery rooms,
central sterile processing, and protective environment rooms. This requirement shall
not apply to terminal units and sound attenuators that have coverings over such
lining meeting ASTM C1071.
(26) HVAC Air Distribution.
(a) Return air systems. For
all areas in Table 1, return air shall be via ducted systems. The bottoms of ventilation
openings shall be at least 6 inches above the floor.
(b) Humidifiers, if provided,
shall meet the requirements of OAR 333-535-0300.
(c) Construction requirements.
Ducts that penetrate construction intended to protect against X-ray, magnetic, RFI,
or other radiation shall not impair the effectiveness of the protection.
(d) Exhaust systems.
(A) To enhance the efficiency
of recovery devices required for energy conservation, combined exhaust systems shall
be permitted unless otherwise noted.
(B) Local exhaust systems shall
be used whenever possible in place of dilution ventilation to reduce exposure to
hazardous gases, vapors, fumes, or mists.
(C) Fans serving exhaust systems
shall be located at the discharge end and shall be readily serviceable.
(D) Airborne infection isolation
rooms and other rooms containing contaminated exhaust such as bronchoscopy, decontamination,
and sterilizer equipment rooms shall not be served by exhaust systems incorporating
air to air heat recovery such as heat wheels. Heat recovery systems are acceptable
if there is complete isolation of air streams, such as run-around loops.
(e) 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. Plumbing vents that terminate
above the level of the top of the air intake may be located as close as 10 feet.
(f) New and remodeled ventilation
system installations shall be designed and balanced 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 Division
on request.
(g) Ventilation Hoods. If lab
exhaust hoods, safety cabinets or fume hoods are required per the functional program,
these systems shall meet the requirements of OAR 333-535-0300.
(27) HVAC Filters.
(a) Filter requirements. Air
handling system filtration shall meet the requirements of Table 2.
(b) Filter frames. Filter frames
shall be durable and proportioned to provide an airtight fit with the enclosing
ductwork. All joints between filter segments and enclosing ductwork shall have gaskets
or seals to provide a positive seal against air leakage.
(28) Plumbing Systems.
(a) Standards. Unless otherwise
specified herein, all plumbing systems shall be designed and installed in accordance
with the Oregon Plumbing Specialty Code.
(b) Testing and documentation.
(A) All plumbing systems shall
be tested to demonstrate that equipment installation and operation is appropriate
and functional. Test results shall be documented for maintenance files.
(B) Upon completion of the installation,
the owner shall be furnished with a complete set of manufacturer’s operating,
maintenance, and preventative maintenance instructions; a parts list; and complete
procurement information, including equipment numbers and descriptions.
(C) Operating staff persons
shall be provided with instructions for proper operation of systems and equipment.
Required information shall include all safety or code ratings as needed.
(29) Plumbing and Other Piping
Systems.
(a) General piping and valves.
(A) All piping, except control-line
tubing, fire sprinkler, sanitary waste, vent, and condensate drain shall be identified.
(B) All valves shall be tagged,
and a valve schedule shall be developed for permanent record and reference.
(b) Potable water supply systems.
The following standards shall apply to potable water supply systems:
(A) Valves. Each water service
main, branch main, riser, and branch to a group of fixtures shall have valves.
(i) Stop valves shall be provided
for each fixture.
(ii) Appropriate panels for
access shall be provided at all valves where required.
(B) Dead-end piping (risers
with no flow, branches with no fixture) shall not be installed. In renovation projects,
dead-end piping shall be removed. Empty risers, mains, and branches installed for
future use shall be permitted and shall be valved at the connection to the main.
(c) Hot water systems. The following
standards shall apply to hot water systems. These requirements do not apply to ASCs
that do not perform invasive operations or procedures.
(A) Hot water distribution systems
serving patient care areas shall be under constant recirculation to provide continuous
hot water at each hot water outlet. Non-recirculated fixture branch piping shall
not exceed 25 ft in length.
(B) Provisions shall be included
in the domestic hot water system to limit Legionella bacteria and opportunistic
waterborne pathogens.
(C) Domestic hot water system
in an ASC with Class C operating rooms shall provide backup equipment for hot water
and sterilizer needs.
(d) Plumbing Fixtures.
(A) Hand-washing stations used
by medical and nursing staff, patients, and food handlers shall be trimmed with
valves that can be operated without hands. Single-lever or wrist blade devices shall
be permitted. Sensor-regulated water fixtures shall meet user need for temperature
and length of time the water flows. Electronic faucets shall be capable of functioning
during loss of normal power when the ASC is required to have an emergency generator.
(B) Clinical sinks shall have
an integral trap wherein the upper portion of the water trap provides a visible
seal. Handles on clinical sink faucets shall be at least 6 inches long.
(30) Hemodialysis piping. Where
the functional program includes hemodialysis, the requirements of OAR 333-700-0130
shall be met.
(31) Drainage systems.
(a) Piping.
(A) Drain lines from sinks used
for acid waste disposal shall be made of acid-resistant material. Drain lines from
automatic blood-cell counters using sodium azide shall be made of copper and lead
free materials.
(B) Drainage piping shall not
be installed within the ceiling or exposed in Class B and C operating rooms. Where
exposed overhead drain piping in these areas is unavoidable, special provisions
such as FM 1680 fittings or drain pans shall be made to protect the space below
from leakage, condensation, or dust particles.
(b) Floor drains.
(A) Floor drains shall not be
installed in operating rooms, except as permitted in dedicated cystoscopy rooms.
(B) If a floor drain is installed in a dedicated cystoscopy
room, it shall contain a non-splash, horizontal-flow flushing bowl beneath the drain
plate.
(c) Plaster traps. Where plaster traps
are used, provisions shall be made for appropriate access and cleaning.
(32) Medical Gas and Vacuum
Systems. Station outlets shall be provided per Table 3. The use of portable medical
gas systems shall be considered for ASCs with Class A operating rooms per the functional
program.
(a) Medical gas and vacuum systems.
When provided, piped in medical gas and vacuum systems shall be installed, tested,
and verified prior to use in accordance with NFPA 99, Gas and Vacuum System Chapter
and Other Health Care Facility Chapter. When additions or modifications are made
to a system, the new and existing components in the immediate zone or area located
upstream (for vacuum systems) and downstream (for medical gas systems) of the altered
section shall be tested and verified.
(b) Anesthesia scavenging system.
Each space routinely used for administering inhalation anesthesia shall be served
by a scavenging system to vent waste gases. Gases from the scavenging system shall
be exhausted directly to the outside. If the medical vacuum system is used, the
gas collecting system shall be arranged so that it does not interfere with the patient’s
respiratory system. The anesthesia evacuation system may be a dedicated air exhaust
system, provided the part used for anesthesia gas scavenging exhausts directly to
the outside and is not part of the recirculation system.
(33) Communications Systems.
(a) Locations for terminating
telecommunications and information system devices shall be provided.
(b) A space shall be provided
for central equipment locations. Special air conditioning and voltage regulation
shall be provided when recommended by the manufacturer.
(34) Electronic Safety and Security
Systems and Fire Alarm System. Any fire alarm system shall be as required by NFPA
101 and installed per NFPA 72.
(35) Electrical Systems.
(a) Applicable standards.
(A) All electrical material,
systems, and equipment, including conductors, controls, and signaling devices, shall
be installed in compliance with applicable sections of OESC and NFPA 99. In addition,
an ASC must meet the specific ambulatory health care requirements found at NFPA
99 (Other Health Care Facilities Chapter).
(B) All electrical material
and equipment shall be listed as complying with available standards of listing agencies
or other similar established standards where such standards are required.
(b) Testing and documentation.
(A) Electrical installations,
including alarm and communication systems, shall be tested to demonstrate that equipment
installation and operation is appropriate and functional. Test results shall be
documented for maintenance files.
(B) Upon completion of the installation,
a complete set of manufacturer’s operating, maintenance, and preventative
maintenance instructions; a parts list; and complete procurement information, including
equipment numbers and descriptions shall be available on site.
(C) Operating staff persons
shall be provided with instructions for proper operation of systems and equipment.
Required information shall include all safety or code ratings as needed.
(D) Essential electrical system,
grounding system, and receptacles shall be tested per NFPA 99.
(36) Electrical Distribution
and Transmission.
(a) Switchboards.
(A) Main switchboards shall
be located in an area separate from plumbing and mechanical equipment and shall
be accessible to authorized persons only.
(B) Switchboards shall be convenient
for use and readily accessible for maintenance.
(C) Switchboards shall be located
in dry, ventilated spaces free from corrosive or explosive fumes or gases or any
flammable material.
(b) Panelboards.
(A) Panelboards serving normal
lighting and appliance circuits shall be located on the same floor as the circuits
they serve.
(B) Panelboards serving critical
branch emergency circuits shall be located on each floor.
(C) Panelboards serving life
safety emergency circuits may also serve one floor above and/or below.
(c) Ground-fault circuit interrupters.
(A) Ground-fault circuit interrupters
(GFCIs) shall comply with OESC.
(B) When GFCIs are used in critical
care areas, provisions shall be made to ensure that other essential equipment is
not affected by activation of one interrupter.
(37) Power Generating and Storing
Equipment.
(a) Emergency electrical service.
Emergency lighting and power shall be provided in accordance with NFPA 99, NFPA 101, and NFPA 110.
(b) Emergency generator systems
are required in an ASC that administers inhalation anesthetics and where a patient
requires electrical life support equipment as part of the surgical protocol. An
ASC that is required to have an emergency generator system must also meet the specific
ambulatory health care requirements found at NFPA 99 (Other Health Care Facilities
Chapter).
(38) Lighting.
(a) Lighting shall conform to
the recommended lighting standards for public buildings contained in the OSSC (Means
of Egress Illumination), Illuminating Engineering Society (IES) RP-29 Hospitals
and Health Care Facilities. Approaches to buildings and parking lots, and all occupiable
spaces within the building shall have illuminated fixtures as necessary.
(b) Procedure rooms. A portable
or fixed examination light shall be provided for procedure rooms.
(c) Operating rooms. Operating
rooms shall have general lighting in addition to special lighting units provided
at surgical tables. General lighting and special lighting shall be on separate circuits.
(39) Receptacles (Convenience
Outlets).
(a) Duplex grounded-type receptacles
(convenience outlets) shall be installed in all areas in sufficient quantities for
tasks to be performed as needed. Duplex receptacles shall be provided per Table
4.
(b) Emergency system receptacles.
Electrical receptacle cover plates or electrical receptacles supplied from the emergency
systems shall be distinctively colored or marked for identification. If color is
used for identification purposes, the same color shall be used throughout the ASC.
(40) Call Systems.
(a) General. Signaling and nurse
call equipment shall be provided in an ASC with Class B and C operating rooms and
shall include the following types of call stations: patient stations, staff assist,
bath stations, and code call stations.
(A) Call station locations shall
be as required in Table 5.
(B) Call stations shall report
to an attended location with electronically supervised visual and audible annunciation.
(C) Call system master stations
shall be located at the nurse control station and shall provide audible/visual prompting
and display all pending calls.
(D) In addition to these rules,
call systems shall meet the requirements of Underwriters Laboratory (UL) 1069: Standards
for Hospital Signaling and Nurse Call Equipment and state and local requirements.
(E) Alternate technologies including
radio frequency systems, shall be permitted for call systems in an ASC with Class
A operating rooms.
(b) Patient stations. Patient
stations shall be provided to allow each patient to summon assistance from the nursing
staff. Use of a dual call station shall be permitted when beds are located adjacent
to each other.
(A) The patient station
shall be equipped with the following:
(i) A visible signal once it has been activated.
An indicator light or call assurance lamp that remains lighted until a call is cancelled
shall be provided. In rooms containing two or more patient stations, call assurance
lamps shall be provided at each station; and
(ii) A reset switch for canceling
a call.
(B) The patient station shall
activate a visible signal in the corridor at the patient’s door or at the
nurse station within the room with the patients under constant visual surveillance
and at the master station.
(c) Bath stations. Bath stations
shall be located to the side of toilets within 12 inches of the front of the toilet
bowl and 3 to 4 feet above the floor. A bath station with a pull string that can
be activated by a patient lying on the floor shall be provided at each room containing
a patient water closet, tub, or shower. An alarm in these areas shall be able to
be turned off only at the bath station where it is initiated.
(d)(A) Code call stations. Commonly
referred to as a “Code Blue,” code call stations are meant for use during
a life-threatening situation to summon assistance from others throughout the unit
or department.
(B) The code call station shall
be equipped with a continuous audible or visual confirmation to the person who initiated
the code call.
(e) Staff assist call stations.
Staff assist call stations are meant for use during a non-life threatening situation
to summon assistance from others throughout the unit or department.
[ED. NOTE:
Tables referenced are not included in rule text. Click here for PDF copy of table(s).]
Publications: Publications referenced are available fro mthe agency.
Stat. Auth.: ORS 441.025 &
441.060
Stats. Implemented: ORS 441.025
& 441.060
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(11)(a)-(k); PH 5-2012, f. 3-30-12, cert. ef. 4-1-12
Ambulatory Surgical Centers ASC
333-076-0190
Emergency Preparedness
(1) The ASC shall develop, maintain, update, train and exercise an emergency plan for the protection of all individuals in the event of an emergency, in accordance with the regulations as specified in Oregon Fire Code (Oregon Administrative Rules chapter 837, division 40).
(a) The ASC shall conduct at least two drills every year that document and demonstrate that employees have practiced their specific duties and assignments, as outlined in the emergency preparedness plan.
(2) The emergency plan shall include the contact information for local emergency management. Each facility shall have documentation that the local emergency management office has been contacted and that the facility has a list of local hazards identified in the county hazard vulnerability analysis.
(3) The summary of the emergency plan shall be sent to the Division within one year of the filing of this rule. New facilities that have submitted licensing documents to the state before this provision goes into effect will have one year from the date of license application to submit their plan. All other new facilities shall have a plan prior to licensing. The Division shall request updated plans as needed.
(4) The emergency plan shall address all local hazards that have been identified by local emergency management that may include, but is not limited to, the following:
(a) Chemical emergencies;
(b) Dam failure;
(c) Earthquake;
(d) Fire;
(e) Flood;
(f) Hazardous material;
(g) Heat;
(h) Hurricane;
(i) Landslide;
(j) Nuclear power plant emergency;
(k) Pandemic;
(l) Terrorism; or
(m) Thunderstorms.
(5) The emergency plan shall address the availability of sufficient supplies for staff and patients to shelter in place or at an agreed upon alternative location for a minimum of two days, in coordination with local emergency management, under the following conditions:
(a) Extended power outage;
(b) No running water;
(c) Replacement of food or supplies is unavailable;
(d) Staff members do not report to work as scheduled; and
(e) The patient is unable to return to the pre-treatment shelter.
(6) The emergency plan shall address evacuation, including:
(a) Identification of individual positions’ duties while vacating the building, transporting, and housing residents;
(b) Method and source of transportation;
(c) Planned relocation sites;
(d) Method by which each patient will be identified by name and facility of origin by people unknown to them;
(e) Method for tracking and reporting the physical location of specific patients until a different entity resumes responsibility for the patient; and
(f) Notification to the Division about the status of the evacuation.
(7) The emergency plan shall address the clinical and medical needs of the patients, including provisions to provide:
(a) Storage of and continued access to medical records necessary to obtain care and treatment of patients, and the use of paper forms to be used for the transfer of care or to maintain care on-site when electronic systems are not available.
(b) Continued access to pharmaceuticals, medical supplies and equipment, even during and after an evacuation; and
(c) Alternative staffing plans to meet the needs of the patients when scheduled staff members are unavailable. Alternative staffing plans may include, but is not limited to, on-call staff, the use of travelers, the use of management staff, or the use of other emergency personnel.
(8) The emergency plan shall be made available as requested by the Division and during licensing and certification surveys. Each plan will be re-evaluated and revised as necessary or when there is a significant change in the facility or population of the ASC.
[Publications: Publications referenced are available from the agency.]
Stat. Auth.: ORS 441.025
Stats. Implemented: ORS 441.025
Hist.: PH 13-2008, f. & cert. ef. 8-15-08; PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
333-076-0250
Violations
In addition to non-compliance with any health care facility licensing law or condition of participation, it is a violation to:
(1) Refuse to cooperate with an investigation or survey, including but not limited to failure to permit Division staff access to the ASC, its documents or records;
(2) Fail to implement an approved plan of correction;
(3) Fail to comply with all applicable laws, lawful ordinances and rules relating to safety from fire;
(4) Refuse or fail to comply with an order issued by the Division;
(5) Refuse or fail to pay a civil penalty; or
(6) Fail to comply with rules governing the storage of medical records following the closure of an ASC.
Stat. Auth.: ORS 441.025
Stats. Implemented: ORS 441.015, 441.025 & 441.030
Hist.: PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
333-076-0255
Informal Enforcement
(1) If, during an investigation or survey Division staff document violations of health care facility licensing laws or conditions of participation, the Division may issue a statement of deficiencies that cites the law alleged to have been violated and the facts supporting the allegation.
(2) A signed plan of correction must be received by the Division within 10 business days from the date the statement of deficiencies was mailed to the ASC. A signed plan of correction will not be used by the Division as an admission of the violations alleged in the statement of deficiencies.
(3) An ASC shall correct all deficiencies within 60 days from the date of the exit conference, unless an extension of time is requested from the Division. A request for such an extension shall be submitted in writing and must accompany the plan of correction.
(4) The Division shall determine if a written plan of correction is acceptable. If the plan of correction is not acceptable to the Division, the Division shall notify the ASC administrator in writing and request that the plan of correction be modified and resubmitted no later than 10 working days from the date the letter of non-acceptance was mailed to the administrator.
(5) If the ASC does not come into compliance by the date of correction reflected on the plan of correction or 60 days from date of the exit conference, whichever is sooner, the Division may propose to deny, suspend, or revoke the ASC license, or impose civil penalties.
Stat. Auth.: ORS 441.025
Stats. Implemented: ORS 441.015 & 441.025
Hist.: PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
333-076-0260
Formal Enforcement
(1) If, during an investigation or survey Division staff document substantial failure to comply with health care facility licensing laws, conditions of participation or if an ASC fails to pay a civil penalty imposed under ORS 441.170, the Division may issue a Notice of Proposed Suspension or Notice of Proposed Revocation in accordance with ORS 183.411 through 183.470.
(2) The Division may issue a Notice of Imposition of Civil Penalty for violations of health care facility licensing laws.
(3) At any time the Division may issue a Notice of Emergency License Suspension under ORS 183.430(2).
(4) If the Division revokes an ASC license, the order shall specify when, if ever, the ASC may reapply for a license.
Stat. Auth.: ORS 441.025
Stats. Implemented: ORS 441.015, 441.025, 441.030 & 441.037
Hist.: PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
333-076-0265
Civil Penalties, Generally
(1) A licensee that violates a health care facility licensing law, including OAR 333-076-0250 (violations), is subject to the imposition of a fine not to exceed $500 per day per violation.
(2) In addition to the penalties under section (1) of this rule, civil penalties may be imposed for violations of ORS 441.015 to 441.063, 441.086 or program rules.
(3) In determining the amount of a civil penalty the Division shall consider whether:
(a) The Division made repeated attempts to obtain compliance;
(b) The licensee has a history of noncompliance with health care facility licensing laws;
(c) The violation poses a serious risk to the public's health;
(d) The licensee gained financially from the noncompliance; and
(e) There are mitigating factors, such as a licensee's cooperation with an investigation or actions to come into compliance.
(4) The Division shall document its consideration of the factors in section (3) of this rule.
(5) Each day a violation continues is an additional violation.
(6) A civil penalty imposed under this rule shall comply with ORS 183.745.
Stat. Auth.: ORS 441.025
Stats. Implemented: ORS 441.030 & 441.990
Hist.: PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
333-076-0270
Approval of Accrediting Organizations
(1) An accrediting organization must request approval by the Division to ensure that ASCs meet state licensing standards.
(2) An accrediting organization shall request approval in writing and shall provide, at a minimum:
(a) Evidence that it is recognized as a deemed accrediting organization by CMS; or
(b) If the accrediting organization is not a deemed organization under CMS, provide:
(A) Documentation of program policies and procedures that its accreditation process meets state licensing standards;
(B) Accreditation history; and
(C) References from a minimum of two health care facilities currently receiving services from the organization.
(3) If the Division finds that an accrediting organization has the necessary qualifications to certify that state licensing standards have been met, the Division will enter into an agreement with the accrediting organization permitting it to accredit ASCs in Oregon.
Stat. Auth.: ORS 441.025
Stats. Implemented: ORS 441.062
Hist.: PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
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 Health Authority, 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 441.025 & 442.015
Stats. Implemented: ORS 441.086 & 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 333-076-0400; 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 441.015 & 442.015
Stats. Implemented: ORS 441.015 & 442.015
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 441.060 & 442.015
Stats. Implemented: ORS 441.060 & 442.015
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 441.025 & 442.015
Stats. Implemented: ORS 441.025 & 442.015
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 441.030 & 442.015
Stats. Implemented: ORS 441.030 & 442.015
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 441.086 & 442.015
Stats. Implemented: ORS 441.086 & 442.015
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 441.025 & 442.015
Stats. Implemented: ORS 441.025 & 442.015
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 441.037 & 442.015
Stats. Implemented: ORS 441.037 & 442.015
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 441.025 & 442.015
Stats. Implemented: ORS 441.086 & 442.015
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
(C) Review of documents and records.
(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;
(c) The inspection may include a client audit;
(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 441.025 & 442.015
Stats. Implemented: ORS 441.086 & 442.015
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 441.025 & 442.015
Stats. Implemented: ORS 441.086 & 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 333-076-0410; 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. [Tables not included. See ED. NOTE.]
(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.
[ED. NOTE: Tables referenced are available
from the agency.]
Stat. Auth.: ORS 441.025
& 442.015
Stats. Implemented: ORS 441.025
& 442.015
Hist.: HD 26-1985, f. &
ef. 10-28-85; HD 2-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0415;
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 Oregon
State Public Health Laboratory, Newborn Screening Program, for the Metabolic Diseases
listed in 333-024-0210.
(19) System to ensure that
pulse oximetry screening is performed on every newborn infant delivered at the Birthing
Center before the infant is discharged in conformance with the following requirements:
(a) The pulse oximetry screening
must be performed using evidence-based guidelines such as those recommended by Strategies
for Implementing Screening for Critical Congenital Heart Disease, AR Kemper et al.,
Pediatrics 2011;128(5): e1259–1267.
(b) The Birthing Center must
have policies and procedures based on the guidelines required by subsection (a)
of this section for:
(A) Determining what is considered
a positive screening result; and
(B) Determining what follow-up
services, treatment or referrals must be provided if a newborn infant has a positive
screening result.
(c) A Federal Drug Administration
(FDA) approved motion tolerant pulse oximeter must be used.
(d) The pulse oximetry screening
must be performed no sooner than 24 hours after birth or as close to discharge of
the newborn infant as possible.
(e) Before performing pulse
oximetry screening on newborn infants, individuals must have received training on
how to correctly operate the pulse oximeter and the policies and procedures associated
with the screening. The Birthing Center must document this training.
(f) If a newborn infant is
admitted to a hospital as the result of a transfer from the Birthing Center before
a pulse oximetry screening is performed, the hospital from which the newborn infant
is discharged to home is responsible for performing the screening.
(g) The Birthing Center must
provide the following notifications and document them in the newborn infant’s
medical record:
(A) Prior to the pulse oximetry
screening, notify a parent or legal representative of the newborn about the reasons
for the screening and the risks and consequences of not screening.
(B) Following the pulse oximetry
screening, notify the health care provider responsible for the newborn infant and
the infant’s primary care provider of the results of the screening.
(C) Following the pulse oximetry
screening and prior to discharge, notify a parent or legal representative of the
newborn infant of the screening result, an explanation of its meaning and, if it
is a positive screening result, provide information about the importance of timely
diagnosis and intervention.
(h) A parent or legal representative
of a newborn infant may decline pulse oximetry screening and, if screening is declined,
the Birthing Center must document the declination in the newborn infant’s
medical record.
(i) Following the pulse oximetry
screening, the Birthing Center, in accordance with the applicable standard of care,
must provide any appropriate follow-up services or treatment for the newborn infant
if necessary or provide a referral to a parent or legal representative of the newborn
for follow-up services or treatment if necessary.
(j) The Birthing Center must
document in the newborn infant’s medical record that the screening was performed,
the screening result, the names of the health care providers who were notified of
the screening result, and any follow-up services or treatment or referral for services
or treatment.
(k) No newborn infant may
be refused screening because of the inability of a parent or legal representative
to pay for the screening.
(20) Protocol delineating
the steps to ensure the prompt and safe evacuation of the Center in the event of
emergency situations, such as fire. The Center must ensure the evaluation of staff
in managing such situations by periodic drills for fire, and/or other emergencies.
Such drills must be documented.
(21) System of infection
control to address the prevention and early recognition of the possibility of infection,
and timely and acceptable methods of control. This includes written documentation
of the problem, and measures taken for control, and must at least meet the requirements
of the rules of the Division. Documentation must also include methods for the control
and prevention of cross-infection between clients and services in accordance with
2003 Center for Disease Control and Prevention "Guidelines for Environmental Infection
Control in Health-Care Facilities."
(22) System to be used for
the prevention of Ophthalmia Neonatorum in the newborn OAR 333-019-0036(2). Prophylaxis
for Gonococcal Ophthalmia Neonatorum:
(a) The practitioner attending
the birth of an infant must, after evaluating the infant as being at risk and within
two hours of delivery, instill appropriate prophylactic antibiotic ointment from
single patient use applicators into each eye of the newborn infant;
(b) Parent(s) refusing to
allow prophylaxis for their infant(s) must be informed, by the attending Health
Care Provider, of the risks attendant to such action and must sign a witnessed affidavit
to testify that they have been so informed and nonetheless refuse to allow prophylaxis.
(c) If Vitamin K and/or Gonococcal
Ophthalmia Neonatorum Prophylaxis cannot be administered by the individual delivering
the newborn, methods must be described to ensure that these services are arranged
by referral.
(23) System to ensure that
appropriate vital records are filed according to the rules of the Division.
(24) System for a semi-annual
clinical record audit to evaluate the care process and outcome.
Stat. Auth.: ORS 441.025 & 442.015
Stats. Implemented: ORS 441.025
& 442.015
Hist.: HD 26-1985, f. &
ef. 10-28-85; HD 2-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0420;
PH 15-2006, f. & cert. ef. 6-27-06; PH 18-2013(Temp), f. 12-31-13, cert. ef.
1-1-14 thru 6-29-14; PH 18-2014, f. & cert. ef. 6-17-14
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;
(c) A signed informed consent (refer also to OAR 333-076-0670(12));
(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;
(C) Record of ophthalmic prophylaxis and Vitamin K administration or refusal of same; and
(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 441.025 & 442.015
Stats. Implemented: ORS 441.025 & 442.015
Hist.: HD 26-1985, f. & ef. 10-28-85; HD 2-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0425; 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;
(c) The use of torn or unclean bed linen is prohibited; and
(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 Authority 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 Authority 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;
(C) Earthquake;
(D) Fire;
(E) Flood;
(F) Hazardous material;
(G) Heat;
(H) Hurricane;
(I) Landslide;
(J) Nuclear power plant emergency;
(K) Pandemic;
(L) Terrorism; or
(M) Thunderstorms.
(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;
(C) Replacement of food or supplies is unavailable;
(D) Staff members do not report to work as scheduled; and
(E) The patient is unable to return to the pre-treatment shelter.
(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;
(C) Planned relocation sites;
(D) Method by which each patient will be identified by name and facility of origin by people unknown to them;
(E) Method for tracking and reporting the physical location of specific patients until a different entity resumes responsibility for the patient; and
(F) Notification to the Authority 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 Authority 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
The official copy of an Oregon Administrative Rule is
contained in the Administrative Order filed at the Archives Division,
800 Summer St. NE, Salem, Oregon 97310. Any discrepancies with the
published version are satisfied in favor of the Administrative Order.
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