Okla. Admin. Code § 40:15-1-3 - Forensic drug analysis laboratories
(a)
Approval. Any laboratory in
which analysis for drugs and other intoxicating substances in specimens of
blood, hereafter termed "forensic drug analysis," is performed under the
provisions of Title 47or 3 O.S., Section 303 or 63 O.S., Section 4210A ,
Oklahoma Statutes, shall possess at least the following qualifications and
shall meet the following requirements. Any laboratory complying with such
qualifications and requirements shall be deemed by this Board to be a Forensic
Drug Laboratory approved by the Board of Tests for Alcohol and Drug Influence
and shall be entitled to issuance of a Forensic Drug Laboratory Permit. Such
Laboratory shall continue to satisfy such qualifications and requirements as a
condition of the continued validity of such Permit.
(1)
Qualifications.
Qualifications for forensic drug analysis laboratories (initial permits) are as
follows:
(A) All forensic laboratories and
facilities that are ISO/IEC (International Organization of
Standards/International Electrotechnical Commission) 17025 accredited, or as
defined in 74 O.S. § 150.37 (Forensic Laboratory Accreditation Act), or
permitted by the Board of Tests, may perform testing regardless of
location.
(B) Possession of all
current and valid Federal, State, and local licenses and permits required to
engage in the activities and operations carried out by or in the laboratory,
and compliance with all current Federal, State, and local requirements for such
activities and operations.
(C) The
laboratory shall be at least one (1) of the following:
(i) A clinical laboratory located within and
operated and controlled by an institution which is currently licensed by the
Oklahoma State Department of Health as a general hospital, and which is
currently accredited as a general hospital by the Joint Commission on
Accreditation of Healthcare Organizations. Such clinical laboratory shall be
directed by a qualified doctoral-level director.
(ii) A clinical laboratory which is currently
Federally licensed and/or approved under the implementing Federal regulations
applicable to laboratories pursuant to the Federal Clinical Laboratory
Improvement Amendments of 1988 (P.L. No. 100-578), for the performance of
clinical chemistry and/or toxicology procedures, Title 42, Part 405 et al.,
Code of Federal Regulations, adopted in this Section by reference. Such
clinical laboratory shall be directed by a qualified doctoral-level
director.
(iii) A central or branch
forensic laboratory operated and controlled by the Oklahoma State Bureau of
Investigation.
(iv) A forensic
laboratory operated and controlled by a county or municipal law enforcement
agency.
(v) The Toxicology/Forensic
Science Laboratories of The University of Oklahoma Health Sciences
Center.
(D) The
laboratory shall regularly employ or have on its permanent staff as least one
(1) person holding a currently valid Forensic Drug Analysis Permit issued by
the Board of Tests for Alcohol and Drug Influence.
(E) The laboratory shall have space,
facilities, equipment, and apparatus adequate and appropriate for the
performance of forensic drug analysis.
(2)
Requirements. Requirements
for forensic drug analysis laboratories (initial permits) are as follows:
(A) Submission of a properly completed
application form for Initial Approval, obtainable from the Board, together with
all supporting documentation specified therein.
(B) Maintenance of an adequate and
appropriate quality assurance program and activities in forensic drug analysis,
meeting nationally-recognized standards.
(C) Regular and satisfactory participation
and performance in any program of proficiency testing in forensic drug analysis
conducted by or on behalf of the Board of Tests for Alcohol and Drug Influence,
or required by the Board.
(D)
Regular and satisfactory participation and performance in any program of
proficiency testing in clinical chemistry or toxicology in which the laboratory
is voluntarily enrolled or required to be enrolled as a condition of Federal or
state licensure or approval.
(b)
Renewal of approval.
Laboratories which have been approved by the Board of Tests for Alcohol and
Drug Influence for performance of forensic drug analysis and which hold a
current valid Forensic Drug Laboratory Permit shall be eligible for renewal of
such Permit upon satisfying the following qualifications and requirements as a
condition of the continued validity of such Permit.
(1)
Qualifications.
Qualifications for forensic drug laboratories (renewal permits) are as follows:
(A) Possession of all qualifications
stipulated in this Rule for Initial Approval as a Forensic Drug Laboratory.
(B) Possession of a valid Forensic
Drug Laboratory Permit issued by authority of the Board of Tests for Alcohol
and Drug Influence within the preceding twelve (12) months upon compliance with
the Qualifications and Requirements then in force for Initial Approval or for
Renewal of Approval as a Forensic Drug Laboratory.
(2)
Requirements. Requirements
for forensic drug analysis laboratories (renewal permits) are as follows:
(A) Submission of a properly completed
application form for Renewal of Approval, obtainable from the Board, together
with all supporting documentation specified therein.
(B) Continued satisfactory participation and
performance in the quality assurance and proficiency testing programs and
activities stipulated in this Section as requirements for Initial Approval.
(c)
General conditions of approval. The following general and
continued conditions of Approval apply to every Forensic Drug Laboratory.
(1) Every such Laboratory may be inspected
periodically, during its normal hours, by the State Director of Tests for
Alcohol and Drug Influence or by the State Director's duly authorized
representative(s). Such inspection may include examination of the Laboratory's
pertinent files and records, as well as its facilities.
(2) Every such Laboratory shall maintain a
current file of all methods and procedures employed in such Laboratory for
forensic drug analysis.
(3) Every
such Laboratory shall maintain and retain at least the following records for a
period of at least three (3) years from the date of origin of such records:
(A) An up-to-date record of persons in its
employ or on its staff who are or were engaged in the performance of forensic
drug analysis. Such records shall include, at least, the inclusive employment
dates, qualifications of each such person, and any continuing education or
training pertinent to forensic drug analysis received by each such person
within or outside of the Laboratory.
(B) Records of specimens received by and
subjected to forensic drug analysis within the Laboratory under the provisions
of Title 47 or Title 3 or Title 63, Oklahoma Statutes, including all pertinent
dates and times, identification of such specimens, results obtained and
reported, and the identity of the person(s) who performed each
analysis.
(C) Records of the
internal and external quality assurance programs and proficiency testing
activities and results, in or pertinent to forensic drug analysis,
(4) Every such Laboratory shall be
operated and shall perform its forensic drug activities in substantial
compliance with applicable nationally-recognized standards of good laboratory
practice.
(5) In every such
Laboratory, forensic drug analysis shall be performed only by methods and
procedures approved by the Board of Tests for Alcohol and Drug Influence, and
only by persons holding valid Forensic Drug Analysis Permits.
(d)
Period of
validity. Forensic Drug Laboratory Approval and Forensic Drug Laboratory
Permits shall be valid for one (1) year from the date of Approval or the date
of Permit issuance, respectively, and shall be subject to earlier suspension,
termination, or revocation at the discretion of the Board.
Notes
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