SECTION 310:615-1-3. General considerations and incorporations by reference

(a)   The following national standards are incorporated by reference:

(1)   Facility Guidelines Institute (FGI): Guidelines for Design and Construction of Outpatient Facilities, 2018 Edition; and

(2)   National Fire Protection Association (NFPA)101: Life Safety Code (LSC), 2012 Edition, and 2012 LSC Tentative Interim Amendments (TIA) 12-1, 12-2, 12-3, and 12-4; and NFPA99 Health Care Facilities Code (HCFC), 2012 Edition, excluding chapters 7, 8, 12 and 13, and 2012 HCFC TIA 12-2, 12-3, 12-4, 12-5 and 12-6 adopted in 81 Federal Register 26871 by the Centers for Medicare & Medicaid Services on July 5, 2016.

(b)   Oklahoma statutes prevail if there is conflict between the FGI Guidelines and Oklahoma statutes. For Medicare-certified ambulatory surgical centers, the Life Safety Code adopted by the Centers for Medicare & Medicaid Services prevails if there is a conflict between the Life Safety Code and this Chapter.

(c)   An ambulatory surgical center may submit a request for exception or temporary waiver if the FGI Guidelines create an unreasonable hardship, or if the design and construction for the ambulatory surgical center property offers improved or compensating features with equivalent outcomes to the FGI Guidelines.

(d)   The Department may permit exceptions and temporary waivers of the FGI Guidelines if the Department determines that such exceptions or temporary waivers comply with the requirements of 63 O.S. Section 2657 et seq., this Chapter, and the following:

(1)   Any ambulatory surgical center requesting an exception or temporary waiver shall apply in writing on a form provided by the Department and pay the exception to or temporary waiver of FGI Guidelines fee set in OAC 310:615-1-3.1. The form shall include:

(A)   The FGI Guidelines section(s) for which the exception or temporary waiver is requested;

(B)   Reason(s) for requesting an exception or temporary waiver;

(C)   The specific relief requested; and

(D)   Any documentation which supports the application for exception.

(2)   In consideration of a request for exception or temporary waiver, the Department shall consider the following:

(A)   Compliance with 63 O.S. Section 2657 et seq.;

(B)   The level of care provided;

(C)   The impact of an exception on care provided;

(D)   Alternative policies or procedures proposed; and

(E)   Compliance history with provisions of the FGI Guidelines, Life Safety Code and this Chapter.

(3)   The Department shall permit or disallow the exception or waiver in writing within forty-five (45) calendar days after receipt of the request.

(4)   If the Department finds that a request is incomplete, the Department shall advise the ambulatory surgical center in writing and offer an opportunity to submit additional or clarifying information. The applicant shall have thirty (30) calendar days after receipt of notification to submit additional or clarifying information in writing to the Department of Health, or the request shall be considered withdrawn.

(5)   An ambulatory surgical center which disagrees with the Department's decision regarding the exception or temporary waiver may file a written petition requesting relief through an individual proceeding pursuant to OAC 310:2 (relating to Procedures of the State Department of Health).

(6)   The Department may revoke an exception or temporary waiver through an administrative proceeding in accordance with OAC 310:2 and the Oklahoma Administrative Procedures Act upon finding the ambulatory surgical center is operating in violation of the exception or temporary waiver, or the exception or temporary waiver jeopardizes patient care and safety or constitutes a distinct hazard to life.

(7)   The Department shall publish decisions on requests for exceptions and waivers and make them available to facilities and the public.

(e)   Documentation of the ambulatory surgical center governing body's approval of the functional program shall be sufficient to meet the requirements in this Chapter relating to Department approval of the functional program.

[Source: Revoked and reenacted at 9 Ok Reg 2021, eff 6-11-92; Amended at 34 Ok Reg 1293, eff 10-1-17; Amended at 36 Ok Reg 1710, eff 9-13-19]