Okla. Admin. Code § 310:638-5-2

Current through Vol. 42, No. 7, December 16, 2024

Section 310:638-5-2 - Personnel

The drug screen testing facility shall contract with, or employ, the following personnel to perform, supervise, and report drug screen tests:

(1)Director. The drug screen testing facility shall have a qualified individual to assume professional, organizational, educational, and administrative responsibility for the drug screen testing facility. The director shall possess the following minimum qualifications:

(A) A bachelor's degree from an accredited institution in the chemical, biological, or physical sciences or medical laboratory science; and two (2) or more years of full-time drug testing experience; or

(B) Abachelor's degree from an accredited institution; and four (4) or more years of full-time drug testing experience; or

(C) An associate's degree from an accredited institution in the chemical, biological, or physical sciences or a medical laboratory science; and three (3) or more years of full-time drug testing experience.

(2)Director responsibilities. The director shall be engaged in, and be responsible for, the management of the drug screen testing facility even where another individual has overall responsibility for an entire multispecialty testing facility.

(A) The director shall be responsible for ensuring that there are sufficient personnel with adequate training and experience to supervise and conduct the work of the drug screen testing facility. The director shall ensure the continued competency of drug screen testing facility personnel by documenting their inservice training, reviewing their work performance, and verifying their skills.

(B) The director shall be responsible for the drug screen testing facility having a procedure manual which is complete, up-to-date, available for personnel performing tests, and followed by those personnel. The procedure manual shall be reviewed, signed, and dated by the director whenever procedures are first placed into use, or changed, or when a new individual assumes responsibility for direction of the drug screen testing facility. Copies of all procedures and dates on which they are in effect shall be maintained.

(C) The director shall be responsible:

(i) for maintaining a quality assurance program to ensure the proper performance and reporting of all test results:

(ii) for maintaining acceptable analytical performance for all controls and standards;

(iii) for maintaining quality control testing; and

(iv) for assuring and documenting the validity, reliability, accuracy, precision, and performance characteristics of each test and test system.

(D) The director shall be responsible for assuring all necessary action is taken to maintain satisfactory operation and performance of the drug screen testing facility in response to quality control systems not being within performance specifications, errors in result reporting or in analysis of performance testing results. The director shall ensure that sample results are not reported until all corrective actions have been taken and he or she can ensure that the test results provided are accurate and reliable.

(3)General supervisor. A qualified general supervisor shall be on the premises during all hours in which tests are performed. The general supervisor shall be responsible for day-to-day operations and supervision of analysts. The general supervisor shall possess the following minimum qualifications:

(A) A high school diploma or equivalent and documented training by the manufacturer, or other qualified person, in the operation and maintenance of the test system utilized, to include the instrumentation, test reagents, calibration and quality control materials, and any other equipment or supplies required in the performance of the drug screen testing procedure; and

(B) Have training and experience in the theory and practice of the procedures used in the drug screen testing facility, resulting in a thorough understanding of:

(i) quality control practices and procedures;

(ii) the review, interpretation, and reporting of test results;

(iii) maintenance of chain of custody; and

(iv) proper remedial actions to be taken in response to test systems being out of control limits or detecting aberrant test or quality control results.

(4)Test validation. The drug screen testing facility shall have a qualified individual(s) who reviews all pertinent data and quality control results in order to attest to the validity of the drug screen testing facility's test reports. A drug screen testing facility may designate more than one person to perform this function. This individual(s) shall be any employee who is qualified as director or general supervisor.

(5)Other personnel. Other technical or nontechnical staff shall have the necessary training and skills for the tasks assigned, and shall perform only those procedures that require a degree of skill commensurate with their training, education, and technical ability.

(6)Training. The drug screen testing facility shall make available continuing education programs to meet the needs of facility personnel.

(7)Personnel records. Personnel records shall include at least the following:

(A) verification of education;

(B) initial skills orientation program;

(C) resume of training and experience;

(D) documentation of continuing education;

(E) certification or license, if any;

(F) references;

(G) job descriptions;

(H) records of performance evaluation and advancement;

(I) incident reports; and

(J) results of tests which establish employee competency.

Okla. Admin. Code § 310:638-5-2

Added at 11 Ok Reg 4339, eff 7-14-94 (emergency); Added at 12 Ok Reg 517, eff 12-12-94 (emergency); Added at 12 Ok Reg 3069, eff 7-27-95; Amended at 24 Ok Reg 1183, eff 4-2-07 (emergency); Amended at 25 Ok Reg 2436, eff 7-11-08

Amended by Oklahoma Register, Volume 37, Issue 24, September 1, 2020, eff. 9/11/2020