SMA-163 Application for Approval as Accreditation Body Under 42

DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION
CENTER FOR SUBSTANCE ABUSE TREATMENT

Application for Approval as Accreditation Body
Under 42 CFR § 8.3(b)

Note:

Form Approved: OMB Number 0930-0206
Expiration Date: 09/30/2006
See OMB Statement on Reverse
DATE OF SUBMISSION

This form is required by 42 CFR §8.3(b) pursuant to Sec. 303, Controlled Substances Act (21 USC 823) and the Drug Abuse Prevention and
Control Act of 1970 (42 USC 275 (a)). Failure to report may result in the suspension or revocation of the accreditation body approval.

1. NAME OF ACCREDITATION BODY

2. PURPOSE OF APPLICATION
New G Renewal G

3. ADDRESS OF ACCREDITATION BODY (Include Zip Code)

4. TELEPHONE NUMBER (Include Area Code)
5. FAX NUMBER (Include Area Code)

6. NAME AND ADDRESS OF RESPONSIBLE OFFICIAL (Include
Zip Code)

7. TELEPHONE NUMBER (Include Area Code)
8. FAX NUMBER (Include Area Code)

9. Application
Substance Abuse and Mental Health Services Administration
Division of Pharmacologic Therapies
Attention: OTP Certification Program
Rockwall II Building, Suite 740
5600 Fishers Lane
Rockville, MD 20857
Dear Sir/Madam
As the official responsible for the accreditation body, I submit this
application in triplicate for approval to serve as an accreditation body
under 42 CFR Part 8.
A. I have a copy of, or access to 42 CFR Part 8, Certification of
Opioid Treatment Programs, including 42 CFR §8.4, Accreditation
Body Responsibilities. I have read, understand and will comply with
these regulations which address the accreditation of opioid treatment
programs (OTPs) that treat narcotic addiction with approved opioid
drugs.
B. I have a copy of, or access to 42 CFR Part 2, Confidentiality of
Alcohol and Drug Abuse Patient Records. I have read and understand
the requirements to maintain the confidentiality of alcohol and drug
abuse treatment patient records. I agree to protect the identity of all
patients in accordance with the regulations and agree to maintain
records of accreditation activities for 5 years from the creation of the
record.
C. Attached is evidence of the accreditation body’s nonprofit status
(i.e., of fulfilling Internal Revenue Service requirements as a nonprofit
organization) if the accreditation body is not a State governmental
entity or political subdivision.

E. Attached is a detailed description of the accreditation body’s decision
making process, including: procedures for initiating and performing onsite
accreditation surveys of OTPs, procedures for assessing OTP personnel
qualifications; copies of an application for accreditation, guidelines, instructions,
and other materials that the accreditation body will send to OTPs during the
accreditation process; policies and procedures for notifying OTPs of deficiencies
and for suspending or revoking an OTP’s accreditation; policies and procedures
for ensuring the timely processing of accreditation applications, and a
description of the accreditation body’s’s appeals process to allow OTPs to
contest adverse accreditation decisions.
F. Attached are the policies and procedures established by the accreditation
body to avoid conflicts of interest, or the appearance of conflicts of interest, by
the accreditation body’s’s board members, commissioners, professional
personnel, consultants, administrative personnel, and other representatives.
G. Attached is a description of the education, experience, and training
requirements for the accreditation body’s professional staff, accreditation
survey team membership, and the identification of at least one licensed
physician on the accreditation body’s staff, along with a description of the
accreditation body’s training policies and survey fee schedules with supporting
cost data.
H. Attached is an assurance that the accreditation body will comply with the
accreditation body responsibilities set forth under 42 CFR §8.4, including a
contingency plan for investigating complaints under 42 CFR §8.4 (e)
I. Attached are the policies and procedures that the accreditation body has
established to protect confidential information that the accreditation body will
collect or receive in its role as an accreditation body.
I, as the responsible official, certify that the information submitted in this
application is truthful and accurate.

D. Attached is a set of accreditation elements and a detailed
discussion showing how the proposed accreditation elements will ensure
that each OTP surveyed by the accreditation body is qualified to meet
or is meeting each of the Federal opioid treatment standards set forth
under 42 CFR § 8.12.
RESPONSIBLE OFFICIAL (Signature)

DATE

Please send three copies of this form and all attachments to:
Substance Abuse and Mental Health Services Administration
Attention: OTP Certification Program
Center for Substance Abuse Treatment, Division of Pharmacologic Therapies
Rockwall II Building, Suite 740
5600 Fishers Lane
Rockville, MD 20857
If submitting this form electronically, please submit electronic copies of all attachments by e-mail to [email protected] or submit three copies of all
attachments to the mailing address above.
FORM SMA-163 (revised 2002) (FRONT)

(Submit in triplicate)
Paperwork Reduction Act Statement

Public reporting burden for this collection of information is estimated to average 2 hours per response, including the time for reviewing instructions,
searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments
regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to SAMHSA Reports
Clearance Officer; Paperwork Reduction Project (0930-0206); Room 16-105, Parklawn Building; 5600 Fishers Lane, Rockville, MD 20857. An agency
may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control
number. The OMB control number for this project is 0930-0206.
FORM SMA-163 (revised 2003) (BACK)