333-076-0001
Applicability; Referenced Codes and Standards

(1) At the time of initial licensure ambulatory surgical centers (ASC) and extended stay centers (ESC) must meet the physical environment requirements in these rules including any applicable building and specialty codes in effect at the time of initial licensure.

(2) Subsequent modifications to an ASC or ESC after initial licensure must comply with any applicable building or specialty codes in effect at the time of the modification.

(3) The codes and standards referenced in these rules are for informational purposes only, unless a code or standard is specifically adopted by reference.

Statutory/Other Authority: ORS 441.025 & 441.060
Statutes/Other Implemented: ORS 441.025 & 441.060
History:
PH 1-2019, amend filed 01/07/2019, effective 01/07/2019
PH 5-2012, f. 3-30-12, cert. ef. 4-1-12

333-076-0095
Purpose

The purpose of these rules is to establish standards for the licensure of ambulatory surgical centers and extended stay centers to ensure the health and safety of individuals who receive services from these facilities.

Statutory/Other Authority: ORS 441.025
Statutes/Other Implemented: ORS 441.025
History:
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019

333-076-0101
Definitions

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

(1) "Affiliated with" means controlled by or associated with other persons under common ownership or control.

(2) "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.

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

(4) "Authority" means the Oregon Health Authority.

(5) "CMS" means Centers for Medicare and Medicaid Services.

(6) "Certified ambulatory surgical center" means a facility that is licensed by the Authority and is certified by the CMS as meeting the conditions for coverage for ambulatory surgical services, 42 CFR 416, Subpart C.

(7) "Certified Nurse Anesthetist" (CRNA) means a registered nurse certified by the National Board of Certification and Recertification for Nurse Anesthetists and licensed by the Oregon State Board of Nursing (OSBN).

(8) "Certified Nursing Assistant" (CNA) means a person who is certified by the Oregon State Board of Nursing (OSBN) to assist licensed nursing staff in the provision of nursing care.

(9) "Conditions for Coverage" mean the applicable federal regulations that ASCs are required to comply with in order to participate in the federal Medicare and Medicaid programs.

(10) "Conscious sedation" has the same meaning as "moderate sedation".

(11) "Deemed status" means an ASC that has been inspected by a CMS- approved national accrediting organization, has been found to meet or exceed all applicable Medicare conditions, and CMS finds the ASC to be in compliance.

(12) "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 and the patient’s ability to independently and continuously maintain an airway may be impaired.

(13) "Dentist" means a person licensed under ORS chapter 679 to practice dentistry by the Oregon Board of Dentistry.

(14) "Direct ownership" has the meaning given the term ‘ownership interest’ in 42 CFR 420.201.

(15) "Extended stay center" means a facility that provides extended stay services.

(16) "Extended stay services" means post-surgical and post-diagnostic medical and nursing services provided to a patient who is recovering from a surgical procedure performed in an ambulatory surgical center.

(17) "Financial interest" means a five percent or greater direct or indirect ownership interest.

(18) "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.

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

(20) "Health care facility" (HCF) has the meaning given the term in ORS 442.015.

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

(22) "High complexity non-certified" means a facility that is licensed by the Authority, is not CMS certified, and performs surgical procedures involving deep sedation or general anesthesia.

(23) "Hospital" has the meaning given that term in ORS 442.015.

(24) "Indirect ownership" has the meaning given the term ‘indirect ownership interest’ in 42 CFR 420.201.

(25) "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 Authority.

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

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

(28) "Local hospital" means the closest most appropriate hospital that has the capability to treat medical emergencies or other care associated with the type of surgery performed at the affiliated ASC.

(29) "Moderate complexity non-certified" means a facility licensed by the Authority, is not CMS certified, and performs procedures requiring not more than conscious sedation.

(30) "Moderate 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. Formerly referred to as conscious sedation.

(31) "New construction" means a new building or an addition to an existing building.

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

(33) "Nursing staff" means a person licensed by the OSBN as a registered nurse (RN), licensed practical nurse (LPN) or certified as a nursing assistant (CNA).

(34) "Patient audit" means review of the medical record or patient observation including the care provided to a patient from admission to discharge.

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

(36) "Physician" means a person licensed under ORS chapter 677 to practice medicine or osteopathic medicine by the Oregon Medical Board.

(37) "Podiatric physician and surgeon" means a person licensed under ORS chapter 677 to practice podiatry medicine by the Oregon Medical Board.

(38) "Podiatry" has the meaning given that term in ORS 677.010.

(39) "Registered Nurse" (RN) means a person licensed as a Registered Nurse under ORS chapter 678.

(40) "These rules" means OAR 333-076-0001 through 333-076-0270 and OAR 333-076-0800 through 333-076-1100.

Statutory/Other Authority: ORS 441.025
Statutes/Other Implemented: ORS 441.015-ORS 441.065, 441.098 & 442.015
History:
PH 1-2019, amend filed 01/07/2019, effective 01/07/2019
PH 7-2016, f. & cert. ef. 2-24-16
PH 28-2016, f. & cert. ef. 10-6-13
PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
PH 25-2006, f. 10-31-06, cert. ef. 11-1-06
Reverted to 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
HD 3-1990, f. 1-8-90, cert. ef. 1-15-90

333-076-0102
Application for ASC License and Fees

(1) An applicant wishing to apply for a new or renewal license to operate an ASC shall submit an application on a form prescribed by the Authority and pay the applicable nonrefundable fee as specified in ORS 441.020.

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

(4) An ASC must inform the Authority in writing of any changes in ownership, organizational structure, or other information required on the application form within 30 days of the change. Failure to notify the Authority may result in denial or revocation of the license.

Statutory/Other Authority: ORS 441.025
Statutes/Other Implemented: 441.022, 441.025 & ORS 441.020
History:
PH 1-2019, amend filed 01/07/2019, effective 01/07/2019
PH 257-2018, renumbered from 333-076-0106, filed 11/06/2018, effective 11/06/2018
PH 28-2016, f. & cert. ef. 10-6-13
PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
HD 3-1990, f. 1-8-90, cert. ef. 1-15-90

333-076-0103
ASC Application Review

(1) Upon receipt of an application and the license fee, the Authority shall:

(a) Verify compliance with the applicable sections of ORS chapters 441, 442 and 476, these rules, and Oregon Administrative Rules chapter 333, division 675;

(b) Conduct an on-site licensing survey in accordance with OAR 333-076-0117;

(c) Consult with the State Fire Marshal, deputy or approved authority to ensure the applicant has not received a certificate of non-compliance pursuant to ORS 479.215; and

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

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

Statutory/Other Authority: ORS 441.025
Statutes/Other Implemented: ORS 441.020, 441.022 & 441.025
History:
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019

333-076-0104
Approval of ASC License Application

(1) The Authority shall notify an applicant in writing if a license application is approved and shall include the license with the appropriate classification.

(2) A license shall be issued only for the premises and persons or governmental units named in the application and it is not transferrable or assignable.

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

(4) 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 Authority nor shall any service be offered or provided which is not authorized within the scope of the license issued to such person or facility.

Statutory/Other Authority: ORS 441.025
Statutes/Other Implemented: ORS 441.020, 441.022 & 441.025
History:
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019

333-076-0107
Denial of ASC License Application

If the Authority intends to deny a license application, it shall issue a Notice of Proposed Denial of License Application in accordance with ORS 183.411 through 183.470.

Statutory/Other Authority: ORS 441.025
Statutes/Other Implemented: ORS 441.025 & 441.030
History:
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019

333-076-0108
Expiration and Renewal of ASC 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 and pay the required renewal fee at least 30 days prior to the expiration date upon a form prescribed by the Authority as described in OAR 333-076-0102.

Statutory/Other Authority: ORS 441.025
Statutes/Other Implemented: 441.025 & ORS 441.020
History:
PH 1-2019, amend filed 01/07/2019, effective 01/07/2019
PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
HD 3-1990, f. 1-8-90, cert. ef. 1-15-90

333-076-0110
Return of ASC License and ASC Closure

(1) If an ASC license is suspended, revoked, or if a facility decides to permanently close, the license certificate in the licensee's possession shall be returned to the Authority immediately.

(2) If an ASC decides to voluntarily permanently close, it shall issue a multimedia press release at least 24 hours prior to closure, notifying the public of the closure. The press release must include information about how an individual may obtain their medical records.

(3) An ASC that decides to voluntarily permanently close shall notify the Authority at least 14 days prior to the closure and submit plans for the orderly transfer of the patients and the storage and disposal of medical records. Medical records not claimed that are more than seven years old from the last date of discharge may be destroyed. Medical records not claimed that are less than seven years old from the last date of discharge shall be stored until they are more than seven years old from the last date of discharge.

Statutory/Other Authority: ORS 441.025
Statutes/Other Implemented: ORS 441.025
History:
PH 1-2019, amend filed 01/07/2019, effective 01/07/2019
HD 3-1990, f. 1-8-90, cert. ef. 1-15-90

333-076-0111
ASC Classification

(1) ASCs 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) An ASC licensed by the Authority shall neither assume a descriptive title nor be held out under any descriptive title other than the classification title established by the Authority and under which the ASC 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 Authority unless the ASC files a new application in accordance with OAR 333-076-0102. The Authority shall review the application in accordance with OAR 333-076-0103 and if the Authority finds that the applicant is in compliance with health care facility licensing laws and the regulations relating to the new classification for which application for licensure is made, the Authority shall issue a license for such classification.

Statutory/Other Authority: ORS 441.025 & 441.086
Statutes/Other Implemented: ORS 441.025 & 441.086
History:
PH 1-2019, amend filed 01/07/2019, effective 01/07/2019
PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
HD 3-1990, f. 1-8-90, cert. ef. 1-15-90

333-076-0114
ASC Complaints

(1) Any person may make a complaint verbally or in writing to the Authority regarding an allegation against an ASC of a violation of health care facility licensing laws or regulations.

(2) The identity of a person making a complaint and any personally identifiable information, as that is defined in ORS 432.005, is confidential and not subject to disclosure under ORS 192.311 to 192.478.

(3) An investigation will be carried out as soon as practicable after receipt of a complaint in accordance with OAR 333-076-0116.

(4) 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 Oregon Health Authority, Health Care Regulation and Quality Improvement Program: 800 NE Oregon Street, Suite 465, Portland OR 97232; 971-673-0540."

Statutory/Other Authority: ORS 441.025 & 441.057
Statutes/Other Implemented: ORS 441.025, 441.086 & 441.057
History:
PH 1-2019, amend filed 01/07/2019, effective 01/07/2019
PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
HD 3-1990, f. 1-8-90, cert. ef. 1-15-90

333-076-0116
ASC Investigations

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

(2) An ASC shall permit Authority staff access to the facility during an investigation.

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

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

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

(c) Review of documents and records.

(4) Information obtained by the Authority during an investigation of a complaint or reported violation under this rule is confidential and not subject to public disclosure under ORS 192.410 to 192.505. Upon the conclusion of the investigation, the Authority 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. The Authority 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 676.160 as that information pertains to a licensee of the board.

Statutory/Other Authority: ORS 441.025
Statutes/Other Implemented: ORS 441.025 & 441.057
History:
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019

333-076-0117
ASC Surveys

(1) The Authority shall, in addition to any investigations conducted under OAR 333-076-0116, conduct at least one on-site licensing survey of each ASC every three years to determine compliance with health care facility licensing laws and at such other times as the Authority deems necessary.

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

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

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

(A) The certification or accreditation is recognized by the Authority as addressing the standards and Condition for Coverage requirements of the CMS and other standards set by the Authority;

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

(C) The ASC provides copies of all documentation concerning the certification or accreditation requested by the Authority including:

(i) Written evidence of all corrective actions underway, or completed, in response to approved accrediting organizations recommendations;

(ii) All progress reports; and

(iii) The letter from CMS indicating its deemed status.

(3) If the deemed status of an ASC changes, the ASC administrator must notify the Authority.

(4) An ASC shall permit Authority staff access to the facility during a survey.

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

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

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

(c) Review of documents and records; and

(d) Patient audits.

(6) An ASC shall make all requested documents and records available to the surveyor for review and copying.

(7) Following a survey, Authority staff may conduct an exit conference with the ASC administrator or the administrator's designee. During the exit conference Authority staff shall:

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

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

(8) Following the survey, Authority staff shall prepare and provide the ASC administrator or the administrator's designee specific and timely written notice of the findings.

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

(10) If no deficiencies are found during a survey, the Authority shall issue written findings to the ASC administrator indicating that fact.

(11) If deficiencies are found, the Authority shall take informal or formal enforcement action in accordance with OAR 333-076-0255 or OAR 333-076-0260.

Statutory/Other Authority: ORS 441.025 & 441.062
Statutes/Other Implemented: ORS 441.025, 441.062 & 441.060
History:
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019

333-076-0118
ASC Health Care Practitioner Credentialing

Each ASC shall comply with the health care practitioner credentialing requirements in accordance with OAR chapter 409, division 045.

Statutory/Other Authority: ORS 441.223 & 441.233
Statutes/Other Implemented: ORS 441.226 & 441.228
History:
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019

333-076-0119
ASC 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) Ensure that all health care personnel for whom state licenses or registration are required are currently licensed or registered;

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

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

(4) Ensure that physicians and dentists 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) Ensure that a physician or dentist is not denied medical staff membership or privileges at the facility solely on the basis that the physician or dentist holds medical staff membership or privileges at another ASC.

Statutory/Other Authority: ORS 441.025
Statutes/Other Implemented: ORS 441.025 & 441.055
History:
PH 1-2019, amend filed 01/07/2019, effective 01/07/2019
PH 257-2018, renumbered from 333-076-0115, filed 11/06/2018, effective 11/06/2018
PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
HD 11-1980, f. & ef. 9-10-80; HD 25-1983(Temp), f. & ef. 12-21-83; HD 23-1985, f. & ef. 10-11-85; Renumbered from 333-023-0163(1); HD 3-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0100(1)(a) & (b)

333-076-0120
ASC Medical Staff

(1) The physicians and dentists organized into a medical staff pursuant to OAR 333-076-0119 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 and dentists admitted to practice in the facility to organize into a medical staff;

(b) Procedures for ensuring that physicians and dentists 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 ensuring that physicians and dentists admitted to practice in the facility are currently licensed by the Oregon Medical Board or the Oregon Board of Dentistry;

(e) Procedures for ensuring 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 ensuring that physicians and dentists 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.

Statutory/Other Authority: ORS 441.025
Statutes/Other Implemented: ORS 441.055
History:
PH 1-2019, amend filed 01/07/2019, effective 01/07/2019
HD 3-1990, f. 1-8-90, cert. ef. 1-15-90

333-076-0125
ASC Personnel

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

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

(3) Provisions shall be made for orientation.

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

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

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

(7) 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 Authority.

Statutory/Other Authority: ORS 441.025
Statutes/Other Implemented: ORS 441.025
History:
PH 1-2019, amend filed 01/07/2019, effective 01/07/2019
PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
PH 25-2006, f. 10-31-06, cert. ef. 11-1-06
Reverted to 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
HD 3-1990, f. 1-8-90, cert. ef. 1-15-90

333-076-0130
ASC Policies and Procedures

(1) The governing body of an ASC 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.

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

(3) 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) Patient care;

(e) Nursing service activities;

(f) Infection control;

(g) Visitor's conduct and control;

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

(i) Content and form of medical records;

(j) Release of medical record information;

(k) 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;

(L) Disposal of pathological and other potentially infectious waste and contaminated supplies that meet the requirements in OAR chapter 333, division 56;

(m) Procurement, storage and dispensing of drugs;

(n) 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 chapter 333, division 150;

(o) Cleaning, storage and handling of soiled linen and the storage and handling of clean linen;

(p) Routine laboratory testing;

(q) Annual training, at a minimum, 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;

(r) Essential life saving measures and stabilization of a patient and arrangements for transfer to an appropriate facility;

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

(t) 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 109.640, 109.670, and 109.675; and

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

Statutory/Other Authority: ORS 441.025
Statutes/Other Implemented: ORS 441.025, 441.057, 441.055 & 441.086
History:
PH 34-2023, minor correction filed 09/08/2023, effective 09/08/2023
PH 1-2019, amend filed 01/07/2019, effective 01/07/2019
PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
PH 25-2006, f. 10-31-06, cert. ef. 11-1-06
PH 4-2006(Temp), f. & cert. ef. 3-2-06 thru 8-1-06
HD 3-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0100(2)(a) & (b)(A) - (Q)
HD 23-1985, f. & cert. ef. 10-11-85; Renumbered from 333-023-0163(1)
HD 25-1983(Temp), f. & cert. ef. 12-21-83
HD 11-1980, f. & cert. ef. 9-10-80

333-076-0135
ASC Nursing Services

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

(2) The number and types of nursing staff and surgical technologists 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 or medical assistant shall be on duty at all times patients are present.

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

Statutory/Other Authority: ORS 441.025
Statutes/Other Implemented: ORS 441.025
History:
PH 266-2018, minor correction filed 11/28/2018, effective 11/28/2018
PH 7-2016, f. & cert. ef. 2-24-16
PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
PH 25-2006, f. 10-31-06, cert. ef. 11-1-06
PH 4-2006(Temp), f. & cert. ef. 3-2-06 thru 8-1-06
HD 3-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0100(4)(a) - (c)
HD 23-1985, f. & cert. ef. 10-11-85, Renumbered from 333-023-0163(1)
HD 25-1983(Temp), f. & cert. ef. 12-21-83
HD 11-1980, f. & cert. ef. 9-10-80

333-076-0137
ASC Surgery Services

(1) For purposes of this rule:

(a) "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 the operating room team members during surgery.

(b) "Rural or medically underserved community" means a geographic area of Oregon that is 10 or more miles from the geographic center of a population center of 40,000 or more individuals.

(c) "Surgical technology" means intraoperative surgical patient care that involves:

(A) Preparing an operating room for surgical procedures by ensuring that surgical equipment is functioning properly and safely;

(B) Preparing an operating room and the sterile field for surgical procedures by preparing sterile supplies, instruments and equipment using sterile techniques;

(C) Anticipating the needs of a surgical team based on knowledge of human anatomy and pathophysiology and how those fields relate to the surgical patient and the patient’s surgical procedure; and

(D) Performing tasks as directed in an operating room, including:

(i) Passing instruments, equipment or supplies;

(ii) Sponging or suctioning of an operative site;

(iii) Preparing and cutting suture material;

(iv) Transferring fluids or drugs;

(v) Handling specimens;

(vi) Holding retractors and other equipment;

(vii) Applying electrocautery to clamps on bleeders;

(viii) Connecting drains to suction apparatus;

(ix) Applying dressings to closed wounds; and

(x) Assisting in counting supplies and instruments, including sponges and needles.

(2) An ASC, regardless of classification, shall comply with this rule.

(3) An ASC shall have operating rooms that conform to the applicable requirements in OAR 333-076-0185.

(4) An ASC’s operating rooms must be supervised by an experienced registered nurse or physician.

(5) The duties of a circulating nurse performed in an operating room of an ASC shall be performed by a registered nurse licensed under ORS chapter 678. In all cases requiring general anesthesia, 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.

(6) Nothing in section (5) precludes a circulating nurse from being relieved during a surgical procedure by another circulating nurse assigned to continue the surgical procedure.

(7) An ASC governing body may only permit individuals to practice surgical technology if they have satisfied the following requirements:

(a) Completion of a training program for surgical technologists in a branch of the armed forces of the United States or in the United States Public Health Service Commissioned Corp and completion of 16 hours of continuing education as described in section (14) of this rule every two years;

(b) Completion of a surgical technology education program accredited by the Commission on Accreditation of Allied Health Education Program (CAAHEP) or the Accrediting Bureau of Health Education Schools (ABHES) and certification as a surgical technologist or certification as a subspecialty surgical assistant or surgical technologist issued by the:

(A) National Board of Surgical Technology and Surgical Assisting (NBSTSA);

(B) National Center for Competency and Testing (NCCT); or

(C) International Joint Commission on Allied Health Personnel in Ophthalmology (IJCAHPO);

(c) Practice of surgical technology at least two years between January 1, 2014 and January 1, 2017 in a hospital, ambulatory surgical center or as an employee of a federal government agency or institution and completion of 16 hours of continuing education as described in section (14) of this rule every two years; or

(d) Completion of and is certified by a registered surgical technology apprenticeship program that:

(A) Is approved under ORS 660.002 to 660.210;

(B) Meets the requirements for, and requires participants to receive, certification by the National Center for Competency Testing or its successor organization;

(C) Upon completion awards certification accredited by the National Commission for Certifying Agencies or its successor organization; and

(D) Is approved by the Oregon Health Authority (Authority) in section (8) of this rule.

(8) Authority approval of a registered apprenticeship program:

(a) For approving under this rule, the Authority shall review registered surgical technology apprenticeship programs that have been approved under ORS 660.002 to 660.210 and listed on the Bureau of Labor and Industries’ (BOLI) website. The Authority shall review the occupational standards submitted to BOLI and available at https://www.oregon.gov/boli/apprenticeship/Pages/apprenticeship-opportunities.aspx.

(b) In reviewing the apprenticeship program, the Authority shall:

(A) Only approve a registered apprenticeship program that satisfies the requirements in paragraphs (7)(d)(A) through (C) of this rule.

(B) Consider whether the program’s occupational standards submitted to BOLI implements satisfactory education and training curriculum and requirements to protect health and safety of apprentices and patients, including but not limited to:

(i) Whether the curriculum meets or exceeds the core curriculum standards established by the Association of Surgical Technologists in its Core Curriculum for Surgical Technology, Seventh Edition available at www.ast.org/educators/core curriculum.

(ii) Whether the program requires that the apprentice be supervised when performing surgical technology duties by a surgical technologist who:

(I) Is certified by one of the certifying organizations specified in paragraphs (7)(b)(A) through (C) of this rule;

(II) Is assigned to, and present in, the operating room or procedure room for the duration of the surgical procedure unless it becomes necessary for the supervising surgical technologist to leave the room as part of the surgical procedure;

(III) While acting in a supervisory role, is not assigned to any other patient or procedure; and

(IV) Personally directs delegated tasks and is available to personally respond to any emergency until the patient is removed from the operating room or procedure room.

(9) Prior to permitting any individual to practice surgical technology at the ASC, the ASC governing body must ensure that the individual’s qualifications to practice surgical technology as required by this rule are documented in the individual’s personnel file.

(10) Notwithstanding subsection (7)(b), an ASC may allow a person who is not certified by the NBSTSA, NCCT, or IJCAHPO to practice surgical technology at the ASC for 12 months after the person completes an educational program accredited by the CAAHEP or ABHES.

(11) Notwithstanding subsection (7)(d) of this rule, an ASC may allow an apprentice who does not hold a certification described in paragraph (7)(d)(B) of this rule to practice surgical technology at the ASC if it is a requirement of the surgical technologist apprenticeship program that the apprentice obtain training while on-the-job and the apprentice is at all times while performing surgical technology provided adequate direct supervision as required by the standards for the registered apprenticeship program in which the person is enrolled.

(12) A person not meeting the requirements specified in subsection (7)(b) of this rule may work at an ASC in a rural or medically underserved community for three years from the date that the person began practicing at the ASC as long as the person is actively enrolled in a surgical technology educational program accredited by the CAAHEP or ABHES.

(13) These rules do not prohibit a licensed practitioner from performing surgical technology if the practitioner is acting within the scope of the practitioner’s license and an ASC allows the practitioner to perform such duties.

(14)(a) The continuing education requirements described in subsections (7)(a) and (7)(c) shall:

(A) Consist of 16 hours every two years;

(B) Be tracked by the surgical technologist and is subject to audit by the ASC in which the person is practicing; and

(C) Be relevant to the medical-surgical practice of surgical technology.

(b) Continuing education may include but is not limited to:

(A) Continuing education credits approved by the Association for Surgical Technologist;

(B) Healthcare sponsored conferences, forums, seminars, symposiums or workshops;

(C) Online distance learning courses;

(D) Live lectures at national conferences; or

(E) College courses.

(15) An ASC shall conduct a random audit of a representative sample of the surgical technologists employed by the ASC every two years to verify compliance with educational requirements.

Statutory/Other Authority: ORS 441.025 & ORS 676.890
Statutes/Other Implemented: ORS 441.025, 676.870 – 676.890 & 678.362
History:
PH 49-2023, amend filed 10/23/2023, effective 10/23/2023
PH 5-2023, amend filed 01/24/2023, effective 01/24/2023
PH 1-2019, amend filed 01/07/2019, effective 01/07/2019
PH 28-2016, f. & cert. ef. 10-6-13
PH 7-2016, f. & cert. ef. 2-24-16

333-076-0140
ASC Anesthesia Services (If Provided)

(1) General or regional anesthesia shall be administered only by a physician, dentist or a certified nurse anesthetist. Either the physician or the CRNA shall be present for the administration of general or regional anesthetics, during anesthesia, and the recovery of the patients when any general or regional 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 2012 NFPA 99, Health Care Facilities Code, adopted by reference, unless the governing body's written policy forbids the use or storage of flammable anesthetics in the facility.

Statutory/Other Authority: ORS 441.025
Statutes/Other Implemented: ORS 441.025
History:
PH 1-2019, amend filed 01/07/2019, effective 01/07/2019
PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
HD 3-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0100(5)(a) & (b)
HD 23-1985, f. & cert. ef. 10-11-85, Renumbered from 333-023-0163(1)
HD 25-1983(Temp), f. & cert. ef. 12-21-83
HD 11-1980, f. & cert. ef. 9-10-80

333-076-0145
ASC 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 respective patients by a physician, dentist, podiatrist or other person authorized within the scope of his or 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. Dispensing functions may be delegated to staff assistants when the accuracy and completeness of the prescription is verified by the physician and where no independent judgement of the staff assistant is required.

(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.

Statutory/Other Authority: ORS 441.025
Statutes/Other Implemented: ORS 441.025
History:
PH 1-2019, amend filed 01/07/2019, effective 01/07/2019
PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
HD 3-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0100(6)
HD 23-1985, f. & cert. ef. 10-11-85, Renumbered from 333-023-0163(1)
HD 25-1983(Temp), f. & cert. ef. 12-21-83
HD 11-1980, f. & cert. ef. 9-10-80

333-076-0150
ASC Emergency Services

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

Statutory/Other Authority: ORS 441.025
Statutes/Other Implemented: ORS 441.025
History:
PH 267-2018, minor correction filed 11/28/2018, effective 11/28/2018
HD 3-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0100
HD 23-1985, f. & cert. ef. 10-11-85, Renumbered from 333-023-0163(1)
HD 25-1983(Temp), f. & cert. ef. 12-21-83
HD 11-1980, f. & cert. ef. 9-10-80

333-076-0155
ASC 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.

Statutory/Other Authority: ORS 441.025
Statutes/Other Implemented: ORS 441.025
History:
PH 268-2018, minor correction filed 11/28/2018, effective 11/28/2018
PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
HD 3-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0100(8)(a) & (b)
HD 23-1985, f. & cert. ef. 10-11-85, Renumbered from 333-023-0163(1)
HD 25-1983(Temp), f. & cert. ef. 12-21-83
HD 11-1980, f. & ef. 9-10-80

333-076-0160
Care of ASC 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 their 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 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.

(8) A patient who prefers to communicate in a language other than English shall be provided health care interpreter services in accordance with ORS 413.559 and OAR 950-050-0160.

Statutory/Other Authority: ORS 441.025
Statutes/Other Implemented: ORS 441.025, 441.086, ORS 413.559 & 413.561
History:
PH 22-2023, minor correction filed 04/18/2023, effective 04/18/2023
PH 197-2022, amend filed 09/07/2022, effective 09/21/2022
PH 1-2019, amend filed 01/07/2019, effective 01/07/2019
PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
HD 3-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0100(9)(a) - (e)
HD 23-1985, f. & cert. ef. 10-11-85, Renumbered from 333-023-0163(1)
HD 25-1983(Temp), f. & cert. ef. 12-21-83
HD 11-1980, f. & cert. ef. 9-10-80

333-076-0165
ASC 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, for example, 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 considered 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; and

(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 Authority 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 or her medical record shall be maintained in the facility.

(12) The Authority may require the facility to obtain periodic and at least annual consultation from a qualified medical records consultant, Registered Health Information Administrator (RHIA) or Registered Health Information Technician (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 Authority upon request.

Statutory/Other Authority: ORS 441.025
Statutes/Other Implemented: ORS 441.025
History:
PH 1-2019, amend filed 01/07/2019, effective 01/07/2019
PH 28-2016, f. & cert. ef. 10-6-16
PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
HD 3-1990, f. 1-8-90, cert. ef. 1-15-90

333-076-0170
ASC 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.

Statutory/Other Authority: ORS 441.025
Statutes/Other Implemented: ORS 441.025
History:
PH 1-2019, amend filed 01/07/2019, effective 01/07/2019
PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
HD 3-1990, f. 1-8-90, cert. ef. 1-15-90

333-076-0175
ASC 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 Authority for the control of communicable diseases.

(5) Written isolation procedures in accordance with the 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings, incorporated by reference, 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 (https://www.cdc.gov/infectioncontrol/guidelines/isolation/). Any guidelines published and distributed by the Authority shall also be taken into consideration.

(6) 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 (8) of this rule.

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

(8) Each ASC shall have a tuberculosis infection control plan that includes provisions for employee assessment and screening for protecting patients and employees from tuberculosis in accordance with OAR 333-019-0041.

Statutory/Other Authority: ORS 441.025
Statutes/Other Implemented: ORS 441.025, ORS 433.004 & 433.411
History:
PH 14-2020, amend filed 03/24/2020, effective 03/24/2020
PH 1-2019, amend filed 01/07/2019, effective 01/07/2019
PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
HD 3-1990, f. 1-8-90, cert. ef. 1-15-90

333-076-0180
In-service Training for ASC Nurses

(1) Each year the in-service 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 or certified employee is knowledgeable of the laws and rules governing his or 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.

Statutory/Other Authority: ORS 441.025
Statutes/Other Implemented: ORS 441.025
History:
PH 1-2019, amend filed 01/07/2019, effective 01/07/2019
PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
HD 3-1990, f. 1-8-90, cert. ef. 1-15-90

333-076-0185
ASC Physical Environment

(1) On and after January 7, 2019, any person proposing to construct a new ASC, or proposing to make certain alterations or additions to an existing ASC, must, before commencing new construction, alterations, or additions, comply with OAR chapter 333, division 675 and these rules.

(2) Only the portion of an existing ASC that is being altered or renovated and any impacted ancillary areas required to ensure full functionality of the ASC must meet the requirements in section (3) of this rule.

(3) An applicant or a licensed ASC must comply with Chapter 2.7 and Chapter 2.9 of the 2018, Facilities Guidelines Institute (FGI), Guidelines for Design and Construction of Outpatient Facilities, adopted by reference including all references to part, subpart, sections, subsections, paragraphs, subparagraphs and appendices except as specified in sections (4) and (5) of this rule. To the extent that other FGI chapters are referenced in Chapter 2.7 and Chapter 2.9, a facility must also comply with the referenced chapters. References in FGI to "and/or" mean "or".

(4) The chapters, sections, subsections, paragraphs, subparagraphs or appendices of the 2018, FGI, Guidelines for Design and Construction of Outpatient Facilities specified in OAR 333-535-0015(6)(a) through (g) and (i) are not adopted by reference and do not apply under this rule.

(5) The amendments made to the 2018, FGI, Guidelines for Design and Construction of Outpatient Facilities, as adopted and incorporated by reference, specified in OAR 333-535-0015(7)(a) through (tt), and (sss) through (uuu) shall apply under this rule.

(6) The Authority may, upon written request, allow minor variations from these requirements (other than fire and life safety requirements) when conditions make certain changes to ASCs impractical to accomplish, as long as the intent of the requirement is met and the care and safety of patients will not be jeopardized. An applicant or ASC must obtain written approval of the Authority in accordance with OAR 333-076-0246, for any minor variation.

(7) An ASC is a distinct entity and must be separate and distinguishable from any 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).

(8) An ASC 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 2012, National Fire Protection Association (NFPA) #101 and #99 Codes.

(9) An ASC must continue to meet all applicable building and physical environment standards, including but not limited to structural, mechanical, electrical, plumbing, fire and life safety codes as required by this rule that were in effect at the time of license, or the standards that applied at the time of a major alteration or new construction. Each instance of non-compliance with a building or physical environment standard or code is a separate violation.

Statutory/Other Authority: ORS 441.025 & 441.060
Statutes/Other Implemented: ORS 441.025 & 441.060
History:
PH 18-2019, amend filed 10/01/2019, effective 01/01/2020
PH 1-2019, amend filed 01/07/2019, effective 01/07/2019
PH 5-2012, f. 3-30-12, cert. ef. 4-1-12
HD 3-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0100(11)(a)-(k)
HD 23-1985, f. & cert. ef. 10-11-85, Renumbered from 333-023-0163(1)
HD 25-1983(Temp), f. & cert. ef. 12-21-83
HD 11-1980, f. & cert. ef. 9-10-80

333-076-0190
ASC Emergency Preparedness

(1) An ASC shall establish and maintain an emergency preparedness program that complies with 42 CFR 416.54 and in accordance with the Oregon Fire Code, Oregon Administrative Rules chapter 837, division 40.

(2) If an ASC is affiliated with an ESC, the ASC shall ensure that its emergency preparedness program integrates the ESC into its planning.

Statutory/Other Authority: ORS 441.025
Statutes/Other Implemented: ORS 441.025
History:
PH 1-2019, amend filed 01/07/2019, effective 01/07/2019
PH 26-2010, f. 12-14-10, cert. ef. 12-15-10
PH 13-2008, f. & cert. ef. 8-15-08

333-076-0246
Waivers

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

(a) Be submitted to the Authority in writing;

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

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

(d) Explain why the ASC is unable to be in compliance, what alternatives were considered if any, and why alternatives (including compliance) were not selected;

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

(f) Include the proposed duration of the waiver.

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

(3) An ASC may not implement a waiver until it has received written approval from the Authority.

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

Statutory/Other Authority: ORS 441.025
Statutes/Other Implemented: ORS 441.025
History:
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019

333-076-0250
ASC Violations

In addition to non-compliance with any health care facility licensing law or conditions for coverage, it is a violation to:

(1) Refuse to cooperate with an investigation or survey, including but not limited to failure to permit Authority 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 Authority;

(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.

Statutory/Other Authority: ORS 441.025
Statutes/Other Implemented: ORS 441.015, 441.025 & 441.030
History:
PH 276-2018, minor correction filed 11/28/2018, effective 11/28/2018
PH 269-2018, minor correction filed 11/28/2018, effective 11/28/2018
PH 28-2016, f. & cert. ef. 10-6-13
PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-076-0255
ASC Informal Enforcement

(1) If, during an investigation or survey Authority staff document violations of health care facility licensing laws or conditions for coverage, the Authority 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 Authority 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 Authority 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 Authority. A request for such an extension shall be submitted in writing and must accompany the plan of correction.

(4) The Authority shall determine if a written plan of correction is acceptable. If the plan of correction is not acceptable to the Authority, the Authority 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 Authority may propose to deny, suspend, or revoke the ASC license, or impose civil penalties.

Statutory/Other Authority: ORS 441.025
Statutes/Other Implemented: ORS 441.015 & 441.025
History:
PH 270-2018, minor correction filed 11/28/2018, effective 11/28/2018
PH 28-2016, f. & cert. ef. 10-6-13
PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-076-0260
ASC Formal Enforcement

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

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

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

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

Statutory/Other Authority: ORS 441.025
Statutes/Other Implemented: ORS 441.015, 441.025, 441.030 & 441.037
History:
PH 271-2018, minor correction filed 11/28/2018, effective 11/28/2018
PH 28-2016, f. & cert. ef. 10-6-13
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, 676.870 to 676.890 or program rules.

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

(a) The Authority 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 Authority 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.

Statutory/Other Authority: ORS 441.025 & 676.890
Statutes/Other Implemented: ORS 441.030, 441.990 & 676.890
History:
PH 1-2019, amend filed 01/07/2019, effective 01/07/2019
PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-076-0270
Approval of ASC Accrediting Organizations

(1) An accrediting organization must request approval by the Authority 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 a nationally recognized Medicare accreditation program approved by CMS; or

(b) If the accrediting organization is not approved by 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 Authority finds that an accrediting organization has the necessary qualifications to certify that state licensing standards have been met, the Authority will enter into an agreement with the accrediting organization permitting it to accredit ASCs in Oregon.

Statutory/Other Authority: ORS 441.025
Statutes/Other Implemented: ORS 441.062
History:
PH 272-2018, minor correction filed 11/28/2018, effective 11/28/2018
PH 28-2016, f. & cert. ef. 10-6-13
PH 26-2010, f. 12-14-10, cert. ef. 12-15-10

333-076-0450
Birthing Centers: 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.

Statutory/Other Authority: ORS 441.025 & 442.015
Statutes/Other Implemented: ORS 441.086 & 442.015
History:
PH 15-2006, f. & cert. ef. 6-27-06
HD 2-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0400
HD 26-1985, f. & ef. 10-28-85

333-076-0470
Birthing Centers: 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.

Statutory/Other Authority: ORS 441.015 & 442.015
Statutes/Other Implemented: ORS 441.015 & 442.015
History:
PH 15-2006, f. & cert. ef. 6-27-06
HD 2-1990, f. 1-8-90, cert. ef. 1-15-90

333-076-0490
Birthing Centers: 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.

Statutory/Other Authority: ORS 441.060 & 442.015
Statutes/Other Implemented: ORS 441.060 & 442.015
History:
PH 15-2006, f. & cert. ef. 6-27-06
HD 2-1990, f. 1-8-90, cert. ef. 1-15-90

333-076-0510
Birthing Centers: 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.

Statutory/Other Authority: ORS 441.025 & 442.015
Statutes/Other Implemented: ORS 441.025 & 442.015
History:
PH 15-2006, f. & cert. ef. 6-27-06
HD 2-1990, f. 1-8-90, cert. ef. 1-15-90

333-076-0530
Birthing Centers: 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.

Statutory/Other Authority: ORS 441.030 & 442.015
Statutes/Other Implemented: ORS 441.030 & 442.015
History:
PH 15-2006, f. & cert. ef. 6-27-06
HD 2-1990, f. 1-8-90, cert. ef. 1-15-90

333-076-0550
Birthing Centers: 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.

Statutory/Other Authority: ORS 441.086 & 442.015
Statutes/Other Implemented: ORS 441.086 & 442.015
History:
PH 15-2006, f. & cert. ef. 6-27-06
HD 2-1990, f. 1-8-90, cert. ef. 1-15-90

333-076-0560
Birthing Centers: 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.

Statutory/Other Authority: ORS 441.025 & 442.015
Statutes/Other Implemented: ORS 441.025 & 442.015
History:
PH 15-2006, f. & cert. ef. 6-27-06
HD 2-1990, f. 1-8-90, cert. ef. 1-15-90

333-076-0570
Birthing Centers: 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.

Statutory/Other Authority: ORS 441.037 & 442.015
Statutes/Other Implemented: ORS 441.037 & 442.015
History:
PH 15-2006, f. & cert. ef. 6-27-06
HD 2-1990, f. 1-8-90, cert. ef. 1-15-90

333-076-0590
Birthing Centers: 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.

Statutory/Other Authority: ORS 441.025 & 442.015
Statutes/Other Implemented: ORS 441.086 & 442.015
History:
PH 15-2006, f. & cert. ef. 6-27-06
HD 2-1990, f. 1-8-90, cert. ef. 1-15-90

333-076-0610
Birthing Centers: 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.

Statutory/Other Authority: ORS 441.025 & 442.015
Statutes/Other Implemented: ORS 441.086 & 442.015
History:
PH 15-2006, f. & cert. ef. 6-27-06
HD 2-1990, f. 1-8-90, cert. ef. 1-15-90

333-076-0630
Birthing Centers: 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.

Statutory/Other Authority: ORS 441.025 & 442.015
Statutes/Other Implemented: ORS 441.086 & 442.015
History:
PH 15-2006, f. & cert. ef. 6-27-06
HD 2-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0410
HD 26-1985, f. & ef. 10-28-85

333-076-0650
Birthing Centers: 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.]

Statutory/Other Authority: ORS 441.025 & 442.015
Statutes/Other Implemented: ORS 441.025 & 442.015
History:
PH 15-2006, f. & cert. ef. 6-27-06
HD 2-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0415
HD 26-1985, f. & ef. 10-28-85

333-076-0670
Birthing Centers: 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.

Statutory/Other Authority: ORS 441.025 & 442.015
Statutes/Other Implemented: ORS 441.025 & 442.015
History:
PH 18-2014, f. & cert. ef. 6-17-14
PH 18-2013(Temp), f. 12-31-13, cert. ef. 1-1-14 thru 6-29-14
PH 15-2006, f. & cert. ef. 6-27-06
HD 2-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0420
HD 26-1985, f. & ef. 10-28-85

333-076-0690
Birthing Centers: 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.

Statutory/Other Authority: ORS 441.025 & 442.015
Statutes/Other Implemented: ORS 441.025 & 442.015
History:
PH 15-2006, f. & cert. ef. 6-27-06
HD 2-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0425
HD 26-1985, f. & ef. 10-28-85

333-076-0710
Birthing Centers: 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 (OAR 837-040).

(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.

Statutory/Other Authority: ORS 441.020 & 442.015
Statutes/Other Implemented: ORS 441.020 & 442.015
History:
PH 13-2008, f. & cert. ef. 8-15-08
PH 15-2006, f. & cert. ef. 6-27-06
HD 2-1990, f. 1-8-90, cert. ef. 1-15-90, Renumbered from 333-076-0430
HD 26-1985, f. & ef. 10-28-85

333-076-0800
Extended Stay Center (ESC) Applicability

Effective January 7, 2019, an extended stay center (ESC) licensed in accordance with OAR 333-076-0820 may provide post-surgical and post-diagnostic medical and nursing services to a patient who is recovering from a surgical procedure performed in an affiliated ambulatory surgical center (ASC).

Statutory/Other Authority: ORS 441.025 & OL 2018 Chapter 50
Statutes/Other Implemented: ORS 441.015 & OL 2018 Chapter 50
History:
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019

333-076-0805
Application for ESC License and Fees

(1) An applicant wishing to apply for a new or renewal license to operate an ESC shall submit an application on a form prescribed by the Authority and pay the nonrefundable fee.

(a) The fee for an initial application is $20,000.

(b) The annual renewal fee is $4,100.

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

(3) An ESC must inform the Authority in writing of any changes in ownership, organizational structure, or other information required on the application form within 30 days of the change. Failure to notify the Authority may result in denial or revocation of the license.

Statutory/Other Authority: ORS 441.025 & OL 2018 Chapter 50
Statutes/Other Implemented: ORS 441.020, 441.022, 441.025 & OL 2018 Chapter 50
History:
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019

333-076-0810
ESC Application Review

(1) Upon receipt of an application and the license fee, the Authority shall:

(a) Verify compliance with the applicable sections of ORS chapters 441, 442 and 476, these rules, and Oregon Administrative Rules chapter 333, division 675; and

(b) Conduct an on-site licensing survey in accordance with OAR 333-076-0860 and in coordination with the State Fire Marshal's Office.

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

Statutory/Other Authority: ORS 441.025 & OL 2018 Chapter 50
Statutes/Other Implemented: ORS 441.020, 441.022, 441.025 & OL 2018 Chapter 50
History:
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019

333-076-0820
Approval of ESC License Application

(1) For purposes of this rule, "operating room" means a room designated and equipped for performing invasive procedures and includes procedure rooms where surgical procedures that do not required a sterile environment are performed.

(2) The Authority shall notify an applicant in writing if a license application is approved and shall include the license with the appropriate information.

(3) A license shall be issued only for the premises and persons or governmental units named in the application and it is not transferrable or assignable.

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

(5) No person or ESC 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 Authority nor shall any service be offered or provided which is not authorized within the scope of the license issued to such person or facility.

(6) An ESC must not be located within a rural area as defined by the Office of Rural Health.

(7) In order to be licensed and to maintain a license, an ESC must be affiliated with an Oregon licensed ASC whose license is in good standing. The affiliated ASC:

(a) May not be affiliated with any other ESC;

(b) Must be physically contiguous with the ESC;

(c) Must be certified by the CMS as participating in the ASC quality reporting program administered by CMS;

(d) Must be accredited by an accrediting organization approved by CMS in accordance with 42 CFR 488.4; and

(e) Must have demonstrated safe operating procedures in an outpatient surgery setting located in Oregon for no less than 24 consecutive months. Safe operating procedures are demonstrated by the absence of any condition level deficiency pursuant to the CMS, Conditions for Coverage for Ambulatory Surgery Centers that has not been corrected.

(8) An ESC may be affiliated with only one ASC.

(9) An ESC may have no more than two recovery beds for each operating room that is in its affiliated ASC and shall have no more than 10 recovery beds total.

Statutory/Other Authority: ORS 441.025 & OL 2018 Chapter 50
Statutes/Other Implemented: ORS 441.022, 441.025 & OL 2018 Chapter 50
History:
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019

333-076-0830
Denial of ESC License Application

If the Authority intends to deny a license application, it shall issue a Notice of Proposed Denial of License Application in accordance with ORS 183.411 through 183.470.

Statutory/Other Authority: ORS 441.025 & OL 2018 Chapter 50
Statutes/Other Implemented: ORS 441.025, 441.030 & OL 2018 Chapter 50
History:
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019

333-076-0840
Expiration and Renewal of ESC License

Each license to operate an ESC shall expire on December 31 following the date of issue, and if a renewal is desired, the licensee shall make application and pay the required renewal fee at least 30 days prior to the expiration date upon a form prescribed by the Authority as described in OAR 333-076-0805.

Statutory/Other Authority: ORS 441.025 & OL 2018 Chapter 50
Statutes/Other Implemented: ORS 441.020, 441.025 & OL 2018 Chapter 50
History:
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019

333-076-0850
Return of ESC License and ESC Closure

(1) If an ESC license is suspended, revoked, or if an ESC decides to permanently close, the license certificate in the licensee's possession shall be returned to the Authority immediately.

(2) If an ESC decides to voluntarily permanently close, it shall issue a multimedia press release at least 24 hours prior to closure, notifying the public of the closure. The press release must include information about how an individual may obtain their medical records.

(3) An ESC that decides to voluntarily permanently close shall notify the Authority at least 14 days prior to the closure and submit plans for the orderly transfer of the patients and the storage and disposal of medical records. Medical records not claimed that are more than seven years old from the last date of discharge may be destroyed. Medical records not claimed that are less than seven years old from the last date of discharge shall be stored until they are more than seven years old from the last date of discharge.

Statutory/Other Authority: ORS 441.025 & OL 2018 Chapter 50
Statutes/Other Implemented: ORS 441.025 & OL 2018 Chapter 50
History:
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019

333-076-0860
ESC Surveys

(1) The Authority shall, in addition to any investigations conducted under OAR 333-076-0880, conduct at least one on-site licensing survey of each ESC every three years to determine compliance with health care facility licensing laws and at such other times as the Authority deems necessary.

(2) An ESC shall permit Authority staff access to the facility during a survey.

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

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

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

(c) Review of documents and records, including documents and records of the affiliated ASC if necessary; and

(d) Patient audits.

(4) An ESC shall make all requested documents and records available to the surveyor for review and copying.

(5) Following a survey, Authority staff may conduct an exit conference with the ESC administrator or the administrator's designee. During the exit conference Authority staff shall:

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

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

(6) Following the survey, Authority staff shall prepare and provide the ESC administrator or the administrator's designee specific and timely written notice of the findings.

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

(8) If no deficiencies are found during a survey, the Authority shall issue written findings to the ESC administrator indicating that fact.

(9) If deficiencies are found, the Authority shall take informal or formal enforcement action in compliance with OAR 333-076-1080 or OAR 333-076-1090.

Statutory/Other Authority: ORS 441.025 & OL 2018 Chapter 50
Statutes/Other Implemented: ORS 441.025, 441.060 & OL 2018 Chapter 50
History:
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019

333-076-0870
ESC Complaints

(1) Any person may make a complaint verbally or in writing to the Authority regarding an allegation against an ESC of a violation of health care facility licensing laws or regulations.

(2) The identity of a person making a complaint and any personally identifiable information, as that is defined in ORS 432.005, is confidential and not subject to disclosure under ORS 192.311 to 192.478.

(3) An investigation will be carried out as soon as practicable after receipt of a complaint in accordance with OAR 333-076-0880.

(4) An ESC 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 extended stay center and the services provided here, contact the Oregon Health Authority, Health Care Regulation and Quality Improvement Program: 800 NE Oregon Street, Suite 465, Portland OR 97232; 971-673-0540."

Statutory/Other Authority: ORS 441.025 & OL 2018 Chapter 50
Statutes/Other Implemented: ORS 441.025, 441.057 & OL 2018 Chapter 50
History:
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019

333-076-0880
ESC Investigations

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

(2) An ESC shall permit Authority staff access to the facility during an investigation.

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

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

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

(c) Review of documents and records, including documents and records of the affiliated ASC.

(4) Information obtained by the Authority during an investigation of a complaint or reported violation under this rule is confidential and not subject to public disclosure under ORS 192.410 to 192.505. Upon the conclusion of the investigation, the Authority 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 ESC. The Authority may use any information obtained during an investigation in an administrative or judicial proceeding concerning the licensing of an ESC, and may report information obtained during an investigation to a health professional regulatory board as defined in ORS 676.160 as that information pertains to a licensee of the board.

Statutory/Other Authority: ORS 441.025 & OL 2018 Chapter 50
Statutes/Other Implemented: ORS 441.025, 441.057 & OL 2018 Chapter 50
History:
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019

333-076-0890
ESC Health Care Practitioner Credentialing

Each ESC shall comply with the health care practitioner credentialing requirements in accordance with OAR chapter 409, division 045.

Statutory/Other Authority: ORS 441.223 & 441.233
Statutes/Other Implemented: ORS 441.226 & 441.228
History:
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019

333-076-0900
ESC Governing Body

(1) The governing body of each ESC 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:

(a) Establish in writing the ESC's scope of services and qualifications for an administrator;

(b) Designate an administrator, in writing, who is directly responsible for the daily operations of the ESC;

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

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

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

(f) Ensure that physicians and dentists 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

(g) Ensure that a physician or dentist is not denied medical staff membership or privileges at the facility solely on the basis that the physician or dentist holds medical staff membership or privileges at another ESC.

(2) The governing body for an ESC may be the same governing body as the affiliated ASC. All actions of the ESC governing body must be separate and distinct from the ASC governing body.

(3) The administrator for an ESC may be the same administrator as the affiliated ASC. An administrator responsible for the daily operations of both the ESC and the affiliated ASC may have clinical responsibilities in either the ASC or ESC but shall not have clinical responsibilities in both facilities at the same time.

(4) An ESC must keep its own records that are separate and distinct from the affiliated ASC.

Statutory/Other Authority: ORS 441.025 & OL 2018 Chapter 50
Statutes/Other Implemented: ORS 441.025, 441.055 & OL 2018 Chapter 50
History:
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019

333-076-0910
ESC Medical Staff

(1) The physicians and dentists organized into a medical staff pursuant to OAR 333-076-0900 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 and dentists admitted to practice in the ESC to organize into a medical staff;

(b) Procedures for ensuring that physicians and dentists admitted to practice in the ESC 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 ensuring that physicians and dentists admitted to practice in the ESC are currently licensed by the Oregon Medical Board or the Oregon Board of Dentistry;

(e) Procedures for ensuring that the ESC’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 ensuring that physicians and dentists 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.

Statutory/Other Authority: ORS 441.025 & OL 2018 Chapter 50
Statutes/Other Implemented: ORS 441.055 & OL 2018 Chapter 50
History:
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019

333-076-0920
ESC Personnel

(1) Each ESC shall maintain a sufficient number of qualified personnel to provide effective patient care and all other related services that are separate and distinct from the affiliated ASC.

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

(3) Provisions shall be made for initial orientation.

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

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

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

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

(8) 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 Authority.

Statutory/Other Authority: ORS 441.025 & OL 2018 Chapter 50
Statutes/Other Implemented: ORS 441.025 & OL 2018 Chapter 50
History:
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019

333-076-0930
ESC Policies and Procedures

(1) The governing body of an ESC 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 that are separate and distinct from the affiliated ASC.

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

(3) An ESC shall develop and implement written policies and procedures including but not limited to:

(a) Admission and discharge criteria. Such policies shall be evaluated annually and rewritten as needed. Documentation of the policy evaluation is required;

(b) Patient care;

(c) Transfer criteria that meets the requirements in OAR 333-076-0950;

(d) Patient notification requirements including but not limited to:

(A) Oral and written notification about financial interest as required by ORS 441.098;

(B) Oral and written notification that services are not covered by Medicare;

(C) The manner in which care will be provided in the event that complications occur beyond what the ESC has the capability to provide; and

(D) The manner in which patients may express concerns regarding the ESC and the services provided. The information must include contact information for the Authority;

(e) Nursing service activities;

(f) Infection control;

(g) Visitor's conduct and control;

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

(i) Content and form of medical records that includes the requirements in OAR 333-076-1010;

(j) Release of medical record information including patient access to his or her medical record;

(k) 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;

(L) Disposal of pathological and other potentially infectious waste and contaminated supplies that meets the requirements in OAR chapter 333, division 56;

(m) Procurement, storage and dispensing of drugs;

(n) Provision of dietary services that conforms to Food Sanitation Rules, OAR chapter 333, division 150 and OAR 333-076-1000.

(o) Cleaning, storage and handling of soiled linen and the storage and handling of clean linen;

(p) Routine laboratory testing;

(q) Annual training, at a minimum, in emergency procedures, including, but not limited to:

(A) Procedures for fire and other disasters;

(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;

(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 109.640, 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.

Statutory/Other Authority: ORS 441.025 & ORS 441.026
Statutes/Other Implemented: ORS 441.025 & ORS 441.026
History:
PH 39-2023, minor correction filed 09/08/2023, effective 09/08/2023
PH 35-2023, minor correction filed 09/08/2023, effective 09/08/2023
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019

333-076-0940
ESC Admission Criteria, Patient Care and Discharge

(1) A patient may only be admitted to an ESC if the patient:

(a) Was discharged from the affiliated ASC where the procedure was performed in accordance with these rules;

(b) Will require a stay of not more than 48 hours from the time the patient was admitted to the affiliated ASC;

(c) Falls within the American Society of Anesthesiologists, Physical Status Classification System: ASA I or ASA II, or ASA III with only mild to moderate systematic disease but medically stable; and

(d) Is physiologically stable at the time of admission and has experienced no intraoperative or postoperative complications that would cause the patient to be ineligible for admission based on these rules.

(2) After admission to the ESC, if a patient is no longer physiologically stable, the patient shall be transferred to a local hospital.

(3) A patient is not eligible for admission to an ESC if the patient requires:

(a) Intensive care services, coronary care services or critical services;

(b) Administration of blood;

(c) Continuous monitoring due to instability of vital signs;

(d) Continuous IV pain medications; or

(e) Has an active or acute infectious condition.

(4) The following must be entered into a patient's ESC medical record at the time of admission:

(a) A current medical history and physical examination performed or approved by a member of the ESC medical staff;

(b) Patient diagnosis;

(c) A discharge summary from the affiliated ASC including the surgical procedure performed, type of anesthesia used, medications given, recovery events and any other pertinent information regarding the patient's status;

(d) Physician orders;

(e) Documentation concerning advance directives; and

(f) Any other underlying medical condition that could be relevant to the patient's care.

(5) A patient may only be admitted to an ESC by a physician who has clinical privileges at the ESC.

(6) 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.

(7) No medications or treatments shall be given without the order of a physician or other individual authorized to give such an order within the scope of their license.

(8) A physician must evaluate each patient for discharge from the ESC and must sign a discharge order.

(9) Each patient shall be given written instructions upon discharge covering signs and symptoms of complications as well as any necessary follow-up instructions for routine or emergency care.

(10) A patient must be discharged from the ESC within 48 hours from the time of admission to the affiliated ASC.

(11) A patient who prefers to communicate in a language other than English shall be provided health care interpreter services in accordance with ORS 413.559 and OAR 950-050-0160.

Statutory/Other Authority: ORS 441.025 & 441.026
Statutes/Other Implemented: ORS 441.025, 441.026, ORS 413.559 & 413.561
History:
PH 23-2023, minor correction filed 04/18/2023, effective 04/18/2023
PH 197-2022, amend filed 09/07/2022, effective 09/21/2022
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019

333-076-0950
ESC Patient Transfer

(1) An ESC shall have a policy for essential life saving measures and stabilization of a patient and immediate transfer, to a local hospital, of a patient requiring medical care that exceeds the capabilities of the ESC or when care extends beyond the 48-hour time frame from admission to the affiliated ASC. The policy must address the following:

(a) Circumstances warranting transfer, including the person responsible for making the transfer decision;

(b) Documentation that must accompany the patient being transferred including but not limited the requirements identified in OAR 333-076-0165(3)(b) and the name of the affiliated ASC; and

(c) Arrangement for immediate emergency transport of the patient including communication with the local receiving hospital.

(2) A written transfer agreement must be in place with at least one local hospital or the ESC must be affiliated with an ASC in which all of the physicians performing surgeries have admitting privileges at a local hospital that has the capability to treat patients requiring medical care that exceeds the capability of the ESC.

Statutory/Other Authority: ORS 441.025 & OL 2018 Chapter 50
Statutes/Other Implemented: ORS 441.025 & OL 2018 Chapter 50
History:
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019

333-076-0960
ESC Nursing Services

(1) In an ESC, a registered nurse with experience in post-operative care shall be responsible for the direction of nursing services and for the nursing care provided to patients.

(2) The number and types of nursing staff necessary for an ESC shall be based on the number of patients and the health care needs of each patient.

(a) At least one registered nurse and one of the following employees shall be on duty at all times patients are present in the ESC:

(A) Nursing staff;

(B) Health care professional licensed by a health care professional licensing board defined in ORS 676.160; or

(C) Unlicensed assistive personnel.

(b) A registered nurse shall be assigned to each patient in the ESC for the duration of the patient's stay.

(c) A registered nurse shall be responsible for completing a nursing assessment of each patient which addresses patient care needs.

(d) There shall be at least one registered nurse with specialized training or experience in emergency care on the premises and immediately interruptible to be able to respond rapidly to provide emergency treatment whenever there is a patient in the ESC.

(3) Each year the nursing staff of an ESC shall receive in-service training on 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.

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

Statutory/Other Authority: ORS 441.025 & OL 2018 Chapter 50
Statutes/Other Implemented: ORS 441.025 & OL 2018 Chapter 50
History:
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019

333-076-0970
ESC Pharmacy Services

(1) In an ESC 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 respective patients by a physician, dentist, podiatrist or other person authorized within the scope of his or her license to so dispense or administer such drugs. Prescribed drugs already prepared for patients in the ESC 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 and the Oregon Board of Pharmacy.

(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. 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. Dispensing functions may be delegated to staff assistants when the accuracy and completeness of the prescription is verified by the physician and where no independent judgement of the staff assistant is required.

(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 ESC are subject to ORS chapter 689 and the rules thereunder.

Statutory/Other Authority: ORS 441.025 & OL 2018 Chapter 50
Statutes/Other Implemented: ORS 441.025 & OL 2018 Chapter 50
History:
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019

333-076-0980
ESC Laboratory Services

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

(2) Notwithstanding section (1) of this rule, an affiliated ASC may provide laboratory services for the ESC if:

(a) The ASC is able to provide the laboratory services and complies with OAR 333-076-0155;

(b) There is a written agreement between the affiliated ASC and the ESC to provide laboratory services; and

(c) All patient records for laboratory services are kept separate and distinct from the ASC.

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

Statutory/Other Authority: ORS 441.025 & OL 2018 Chapter 50
Statutes/Other Implemented: ORS 441.025 & OL 2018 Chapter 50
History:
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019

333-076-0990
ESC Radiologic Services

(1) An ESC may provide radiologic services directly or under a contract with the affiliated ASC or other party.

(2) All radiologic services must meet hospital radiologic service requirements at 42 CFR 482.26(b), (c)(2) and (d)(2), regardless of whether the service is provided directly or under contract.

Statutory/Other Authority: ORS 441.025 & OL 2018 Chapter 50
Statutes/Other Implemented: ORS 441.025 & OL 2018 Chapter 50
History:
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019

333-076-1000
ESC Dietary Services

(1) An ESC shall provide dietary services to admitted patients that conforms to Food Sanitation Rules, OAR chapter 333, division 150.

(2) An ESC may contract with an external vendor to prepare and deliver food to the ESC. The ESC must:

(a) Have a written contract between the food service vendor and the ESC;

(b) Have a copy of the food service vendor's license; and

(c) Be able to store, refrigerate and reheat food to meet the dietary needs of a patient.

Statutory/Other Authority: ORS 441.025 & OL 2018 Chapter 50
Statutes/Other Implemented: ORS 441.025 & OL 2018 Chapter 50
History:
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019

333-076-1010
ESC Medical Records

(1) An ESC medical record shall be maintained for every patient admitted to the ESC for care that is separate and distinct from the affiliated ASC.

(2) Each ESC patient medical record shall be legible, reproducible and include at a minimum:

(a) A copy of the patient's medical record from the affiliated ASC meeting the requirements of OAR 333-076-0165(2);

(b) Laboratory and radiology test results;

(c) Medication and medical treatments;

(d) Progress notes;

(e) Nursing observation and assessment;

(f) Treatment plans;

(g) Discharge instructions and condition at discharge;

(h) Transfer documentation, if applicable;

(i) Documentation concerning advance directives, if any; and

(j) Signed discharge summary.

(3) ESC medical records shall be filed in a manner that renders them easily retrievable and shall be protected against unauthorized access, fire, water and theft.

(4) Medical records are the property of the ESC. The medical record, either in original, electronic or microfilm form, shall not be removed from the facility except where necessary for a judicial or administrative proceeding. Authorized personnel of the Authority shall be permitted to review medical records. When an ESC 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.

(5) 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, electronic or other media.

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

(7) If any ESC 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 (5) of this rule.

(8) 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.

(9) The Authority may require the facility to obtain periodic and at least annual consultation from a qualified medical records consultant, Registered Health Information Administrator (RHIA) or Registered Health Information Technician (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 Authority upon request.

Statutory/Other Authority: ORS 441.025 & OL 2018 Chapter 50
Statutes/Other Implemented: ORS 441.025 & OL 2018 Chapter 50
History:
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019

333-076-1020
ESC Quality Assessment and Performance Improvement

(1) The governing body of an ESC 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 ESC 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 ESC. 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 ESC must develop and implement facility-wide preventive strategies and ensure that staff are trained in and familiar with these strategies.

(4) The ESC 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.

Statutory/Other Authority: ORS 441.025 & OL 2018 Chapter 50
Statutes/Other Implemented: ORS 441.025 & OL 2018 Chapter 50
History:
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019

333-076-1030
ESC Infection Control

(1) Each ESC 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 ESC 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 ESC 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 ESC privileges and volunteers on the cause, transmission, and prevention of infections;

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

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

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

(5) Written isolation procedures in accordance with the 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings, incorporated by reference, shall be established and followed by all ESC 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 (https://www.cdc.gov/infectioncontrol/guidelines/isolation/). Any guidelines published and distributed by the Authority shall also be taken into consideration.

(6) 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 (8) of this rule.

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

(8) Each ESC shall have a tuberculosis infection control plan that includes provisions for employee assessment and screening for protecting patients and employees from tuberculosis in accordance with OAR 333-019-0041.

Statutory/Other Authority: ORS 441.025 & OL 2018 Chapter 50
Statutes/Other Implemented: ORS 433.004, 433.411, 441.025 & OL 2018 Chapter 50
History:
PH 14-2020, amend filed 03/24/2020, effective 03/24/2020
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019

333-076-1040
ESC Data Collection and Reporting

Data collection and reporting shall be conducted pursuant to OAR chapter 409, division 22 and in accordance with Oregon Laws 2018, chapter 50, section 2.

Statutory/Other Authority: ORS 441.025 & OL 2018 Chapter 50
Statutes/Other Implemented: ORS 441.025 & OL 2018 Chapter 50
History:
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019

333-076-1050
ESC Physical Environment

(1) On and after January 7, 2019, any person proposing to construct a new ESC, or proposing to make certain alterations or additions to an existing ESC, must, before commencing new construction, alterations, or additions, comply with:

(a) OAR chapter 333, division 675 and these rules; and

(b) The 2018, FGI, Guidelines for Design and Construction of Outpatient Facilities and the 2018, FGI, Guidelines for Design and Construction of Hospitals, as amended and set out in Appendix 1, both of which are adopted by reference, unless otherwise specified in this rule.

(2) An ESC must meet the requirements of any applicable state building and specialty codes in effect at the time of initial licensure.

(3) The Authority may, upon written request, allow minor variations from these requirements (other than fire and life safety requirements) when conditions make certain changes to ESC impractical to accomplish, as long as the intent of the requirement is met and the care and safety of patients will not be jeopardized. An applicant or ESC must obtain written approval of the Authority, in accordance with OAR 333-076-1065, for any minor variation.

(4) An ESC must continue to meet all applicable building and physical environment standards, including but not limited to structural, mechanical, electrical, plumbing, fire and life safety codes as required by this rule that were in effect at the time of license, or the standards that applied at the time of a major alteration or new construction. Each instance of non-compliance with a building or physical environment standard or code is a separate violation.

[ED. NOTE: To view attachments referenced in rule text, click here to view rule.]

Statutory/Other Authority: ORS 441.025, 441.060 & OL 2018 Chapter 50
Statutes/Other Implemented: ORS 441.025, 441.060 & OL 2018 Chapter 50
History:
PH 18-2019, amend filed 10/01/2019, effective 01/01/2020
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019

333-076-1065
ESC Waivers

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

(a) Submitted to the Authority in writing;

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

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

(d) Why the ESC is unable to be in compliance, the alternatives considered and why the alternatives were not selected;

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

(f) The proposed duration of the waiver.

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

(3) An ESC may not implement a waiver until it has received written approval from the Authority.

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

Statutory/Other Authority: ORS 441.025 & OL 2018 Chapter 50
Statutes/Other Implemented: ORS 441.025 & OL 2018 Chapter 50
History:
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019

333-076-1070
ESC Violations

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

(1) Refuse to cooperate with an investigation or survey, including but not limited to failure to permit Authority staff access to the ESC, 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 Authority;

(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 ESC.

Statutory/Other Authority: ORS 441.025 & OL 2018 Chapter 50
Statutes/Other Implemented: ORS 441.015, 441.025, 441.030 & OL 2018 Chapter 50
History:
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019

333-076-1080
ESC Informal Enforcement

(1) If, during an investigation or survey Authority staff document violations of health care facility licensing laws, the Authority 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 Authority within 10 business days from the date the statement of deficiencies was mailed to the ESC. A signed plan of correction will not be used by the Authority as an admission of the violations alleged in the statement of deficiencies.

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

(4) The Authority shall determine if a written plan of correction is acceptable. If the plan of correction is not acceptable to the Authority, the Authority shall notify the ESC 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 ESC 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 Authority may propose to deny, suspend, or revoke the ESC license, or impose civil penalties.

Statutory/Other Authority: ORS 441.025 & OL 2018 Chapter 50
Statutes/Other Implemented: ORS 441.015, 441.025 & OL 2018 Chapter 50
History:
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019

333-076-1090
ESC Formal Enforcement

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

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

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

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

Statutory/Other Authority: ORS 441.025 & OL 2018 Chapter 50
Statutes/Other Implemented: ORS 441.015, 441.025 & OL 2018 Chapter 50
History:
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019

333-076-1100
ESC Civil Penalties

(1) An ESC that violates a health care facility licensing law, including OAR 333-076-1070 (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 Authority shall consider whether:

(a) The Authority 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 Authority 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.

Statutory/Other Authority: ORS 441.025 & OL 2018 Chapter 50
Statutes/Other Implemented: ORS 441.030, 441.025, 441.990 & OL 2018 Chapter 50
History:
PH 1-2019, adopt filed 01/07/2019, effective 01/07/2019