Section 440IAC10-3-2. Requirements for facility certification

   (a) Before commencing services, an OTP applicant shall have the opioid treatment facility and, if applicable, a maximum of one (1) addiction treatment facility certified by the division.

  (b) An OTP applicant shall file an application with the division. The application shall contain the following:

(1) The legal name of the OTP applicant.

(2) A description of the following:

(A) The organizational structure.

(B) The applicant's mission statement.

(C) The services to be provided.

(D) The population to be served.

(3) The location of the following:

(A) The opioid treatment facility.

(B) The addiction treatment facility, if applicable.

(C) The county where both clauses (A) and (B) are located.

(4) Documentation showing that the applicant is accredited by an accreditation body approved by the division and by the United States Department of Health and Human Services, Substance Abuse and Mental Health Services Administration (SAMHSA), including a copy of the following:

(A) The accreditation report.

(B) Any response to the report required by the accreditation body.

(C) The final disposition issued by the accreditation body.

(5) Documentation of any license and inspection for each facility, including the following:

(A) Any business license, certificate of occupancy, zoning permit, or any other documentation required by local laws for the facility and location.

(B) A periodic inspection of security equipment.

(C) A periodic inspection of emergency equipment.

(D) The applicant's procedures for emergency or disaster preparation.

(E) The most recent annual fire inspection report from the appropriate department of jurisdiction.

(6) Documentation showing the following:

(A) The applicant has met the requirements of SAMHSA.

(B) The applicant has a current certification from SAMHSA.

(C) The applicant has the most current federal notification form or forms on file with SAMHSA specifying the names of the following:

(i) The current sponsor.

(ii) The current medical director of the OTP.

(7) Documentation showing the following:

(A) The applicant has met the requirements of the federal Drug Enforcement Agency (DEA).

(B) The applicant has a current controlled substances registration certificate from the DEA.

(C) The applicant's medical director has met the DEA requirements.

(D) The applicant's medical director has a current controlled substances registration certificate from the DEA.

(8) Documentation showing the following:

(A) The applicant has a current controlled substances registration certificate issued by the Indiana board of pharmacy.

(B) The applicant's medical director is a licensed physician.

(C) The applicant's medical director has a current license issued by the medical licensing board of Indiana.

(D) The applicant's medical director has a current controlled substances registration issued by the Indiana board of pharmacy.

(9) Any other materials required by statute.

(Division of Mental Health and Addiction; 440 IAC 10-3-2; filed Dec 30, 2009, 2:00 p.m.: 20100127-IR-440080412FRA; readopted filed May 10, 2016, 11:24 a.m.: 20160608-IR-440160134RFA)