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(b) The Federal CSAT SAMHSA,as required by 42 C.F.R. Part 8 for certification as an opioid treatment <br /> program; and <br /> (c)The federal Drug Enforcement Administration. <br /> (4)An agency must ensure that opiate substitution treatment is provided to an individual in <br /> compliance with the applicable requirements in 42 C.F.R. Part 8 and 21 C.F.R. Part 1301. <br /> (5)The department may deny an application for certification when: <br /> (a)There is not a demonstrated need in the community where the applicant proposes to locate the <br /> program. <br /> (b)There is sufficient availability, access,and capacity of other certified programs near the area <br /> where the applicant is proposing to locate the program. <br /> (c)The applicant has not demonstrated in the past,the capability to provide the appropriate <br /> services to assist individuals using the program to meet goals established by the legislature. <br /> [Statutory Authority: RCW 70.02.290,70.02.340,70.96A.040(4),71.05.560,71.24.035 (5)(c), 71.34.380, <br /> and 2014 c 225. WSR 16-13-087, §388-877B-0405,filed 6/15/16,effective 7/16/16.Statutory Authority: <br /> Chapters 70.02,70.96A,71.05,71.24,71.34,74.50 RCW, RCW 74.08.090,43.20A.890, and 42 C.F.R. Part <br /> 8.WSR 13-12-053, §388-877B-0405,filed 5/31/13,effective 7/1/13.] <br /> WAC 388-877B-0410 <br /> Substance use disorder opiate substitution treatment services—Agency staff requirements. <br /> In addition to meeting the agency administrative and personnel requirements in WAC 388-877-0400 <br /> through 388-877-0530, an agency providing substance use disorder opiate substitution treatment <br /> services must: <br /> (1)Appoint a program sponsor, as defined in 42 C.F.R. Part 8,who is responsible for notifying the <br /> federal Center for Substance Abuse Treatment(CSAT),Substance Abuse and Mental Health Services <br /> Administration (SAM HSA),the federal Drug Enforcement Administration (DEA),the department,and the <br /> Washington State board of pharmacy of any theft or significant loss of a controlled substance. <br /> (2) Ensure there is an appointed medical director who: <br /> (a) Is licensed by department of health (DOH)to practice medicine and practices within their scope <br /> of practice. <br /> (b) Is responsible for all medical services performed.See the program physician responsibilities in <br /> WAC 388-877B-0440. <br /> (c) Ensures all medical services provided are in compliance with applicable federal,state, and local <br /> rules and laws. <br /> (3) Ensure all medical services provided are provided by an appropriate DOH-credentialed medical <br /> provider practicing within their scope of practice. <br /> 6 <br />