[Code of Federal Regulations]

[Title 42, Volume 1]

[Revised as of October 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR8.6]



[Page 61-62]

 

                         TITLE 42--PUBLIC HEALTH

 

    CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 

                                SERVICES

 

PART 8_CERTIFICATION OF OPIOID TREATMENT PROGRAMS--Table of Contents

 

                         Subpart A_Accreditation

 

Sec. 8.6  Withdrawal of approval of accreditation bodies.



    If SAMHSA determines that an accreditation body is not in 

substantial compliance with this subpart, SAMHSA shall take appropriate 

action as follows:

    (a) Major deficiencies. If SAMHSA determines that the accreditation 

body has a major deficiency, such as commission of fraud, material false 

statement, failure to perform a major accreditation function 

satisfactorily, or significant noncompliance with the requirements of 

this subpart, SAMHSA shall withdraw approval of that accreditation body.

    (1) In the event of a major deficiency, SAMHSA shall notify the 

accreditation body of the agency's action and the grounds on which the 

approval was withdrawn.

    (2) An accreditation body that has lost its approval shall notify 

each OTP that has been accredited or is seeking accreditation that the 

accreditation body's approval has been withdrawn. Such notification 

shall be made within a time period and in a manner approved by SAMHSA.

    (b) Minor deficiencies. If SAMHSA determines that the accreditation 

body has minor deficiencies in the performance of an accreditation 

function, that are less serious or more limited than the types of 

deficiencies described in paragraph (a) of this section, SAMHSA will 

notify the body that it has 90 days to submit to SAMHSA a plan of 

corrective action. The plan must include a summary of corrective actions 

and a schedule for their implementation. SAMHSA may place the body on 

probationary status for a period of time determined by SAMHSA, or may 

withdraw approval of the body if corrective action is not taken.

    (1) If SAMHSA places an accreditation body on probationary status, 

the body shall notify all OTPs that have been accredited, or that are 

seeking accreditation, of the accreditation body's probationary status 

within a time period and in a manner approved by SAMHSA.

    (2) Probationary status will remain in effect until such time as the 

body can demonstrate to the satisfaction of SAMHSA that it has 

successfully implemented or is implementing the corrective action plan 

within the established schedule, and the corrective actions taken have 

substantially eliminated all identified problems.

    (3) If SAMHSA determines that an accreditation body that has been 

placed on probationary status is not implementing corrective actions 

satisfactorily or within the established schedule, SAMHSA may withdraw 

approval of the accreditation body. The accreditation body shall notify 

all OTPs that have been accredited, or are seeking accreditation, of the 

accreditation body's loss of SAMHSA approval within a time period and in 

a manner approved by SAMHSA.

    (c) Reapplication. (1) An accreditation body that has had its 

approval withdrawn may submit a new application for approval if the body 

can provide information to SAMHSA to establish that the problems that 

were grounds for withdrawal of approval have been resolved.

    (2) If SAMHSA determines that the new application demonstrates that 

the



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body satisfactorily has addressed the causes of its previous 

unacceptable performance, SAMHSA may reinstate approval of the 

accreditation body.

    (3) SAMHSA may request additional information or establish 

additional conditions that must be met before SAMHSA approves the 

reapplication.

    (4) SAMHSA may refuse to accept an application from a former 

accreditation body whose approval was withdrawn because of fraud, 

material false statement, or willful disregard of public health.

    (d) Hearings. An opportunity to challenge an adverse action taken 

regarding withdrawal of approval of an accreditation body shall be 

addressed through the relevant procedures set forth in subpart C of this 

part, except that the procedures in Sec. 8.28 for expedited review of 

an immediate suspension would not apply to an accreditation body that 

has been notified under paragraph (a) or (b) of this section of the 

withdrawal of its approval.