La. Admin. Code tit. 40 § I-1507

Current through Register Vol. 50, No. 11, November 20, 2024

Section I-1507 - Laboratory Analysis Procedures

A. Receiving/Preparation

1. The laboratory must be secured at all times; procedures to control access by unauthorized personnel shall be in place. Upon receipt of specimens, accession personnel shall inspect packages for evidence of possible tampering and compare information on specimen containers with that on chain of custody forms. Any discrepancies shall be properly noted and described. Any direct evidence of tampering shall be reported immediately to the employer and shall also be noted on the chain of custody form which must accompany all specimens during laboratory possession.

2. Specimen containers and original chain of custody forms will normally be retained within the accession area until all analyses have been completed. Aliquots and intralaboratory chain of custody forms shall be used by laboratory personnel for conducting the initial and confirmatory tests.

B. Initial Test. If the initial drug test is negative, there shall be no confirmation test. The initial testing shall use an immunoassay which meets the requirements of the Food and Drug Administration for commercial distribution. The following initial cutoff levels shall be used when screening specimens to determine usage of these drugs or classes of drugs.

	Initial Test Level (ng/ml)
Marijuana Metabolite	50
Cocaine Metabolites	300
Morphine/Codeine	300
Phencyclidine	25
Amphetamines/Methamphetamines	1000
Alcohol/Ethanol	0.05 gram %/ml

1. These test levels are subject to change by the Office of Workers' Compensation, as advances in technology or other considerations may permit identification and quantification of these substances at lower concentrations.

2. The laboratory will use scientifically accepted initial cutoff levels when screening specimens for other drugs in 21 U.S.C. 812, Schedules I, II, III, IV and V.

3. Some specimens may be subjected to initial testing by methods other than immunoassays, where the latter are unavailable for the detection of specific drugs of special concern. These methods are thin layer, high pressure liquid, and/or gas chromatography. Alternate initial test methods and testing levels shall be submitted for written approval to the director of the Office of Workers' Compensation, or his designee.

C. Confirmary Test. All specimens identified as positive on the initial test shall be confirmed using gas chromatography for alcohol (ethanol) and gas chromatography/mass spectrometry (GC/MS) techniques for drugs in 21 U.S.C. 812, Schedules I, II, III, IV and V at the following cutoff values.

	Confirmatory Test Level (ng/ml)
Marijuana Metabolite*	10
Cocaine Metabolites**	150
Morphine/Codeine	150
Phencyclidine	25
Amphetamines	300
	* Delta-9-tetrahydrocannabinol-9-carboxylic acid ** Benzoylecgonine

1. These test levels are subject to change by the Office of Workers' Compensation as advances in technology or other considerations may permit identification and quantification of these substances at lower concentrations.

2. Confirmation methods and levels for other drugs tested shall be submitted by the employer to the director of the Office of Workers' Compensation, or his designee, for approval. In the absence of an accepted quantitative GC/MS assay procedure, preference will be given to a confirmation of qualitative identification by means of full-scan GC/MS analysis and quantification by an alternate chromatographic method. All methods shall meet commonly accepted analytical standards.

3. Proper chain of custody controls shall always be enforced during confirmation testing. Authorized confirmation technicians shall sign the chain of custody forms and be responsible for each specimen to be tested. The laboratory shall include sufficient safeguards to ensure that unauthorized personnel are prevented from gaining access to the confirmation laboratory.

D. Reporting Results

1. Test results shall be reported to the employer within an average of five working days of receipt of the specimens. The report should contain the specimen number assigned by the submitting employer, the drug testing laboratory accession number, and results of the drug tests. All specimens negative on the initial test or negative on the confirmatory test shall be reported as negative. Only specimens confirmed positive shall be reported positive for a specific drug. Results may be transmitted to the employer by various electronic means (e.g., teleprinter, facsimile, or computer) in a manner consistent with maintaining confidentiality. It is impermissible to provide results verbally by telephone. A certified copy of the original chain of custody form, signed by the laboratory director or laboratory certifying officer, shall be sent to the employer. Certified copies of all analytical results shall be available from the laboratory when requested by appropriate authority.

2. All records pertaining to a given specimen shall be retained by the drug testing laboratory for a minimum of two years.

E. Long-Term Storage. Specimens confirmed positive shall be retained and placed in properly secured long-term frozen storage for at least 365 days. Within this 365-day period, an employer, employee, or the director of the Office of Workers' Compensation Administration may request the laboratory to retain the specimen for additional periods of time. This ensures that the specimen will be available for a possible retest during any administrative or legal proceeding. If the laboratory does not receive a request to retain the specimen during the initial 365-day period, the specimen may be discarded.

F. Retesting Specimens. Should specimen reanalysis be required as a result of challenge or litigation, the quantitation of a drug or metabolite in a specimen may not be subject to the same testing level criteria that were used during the original analysis; some analytes deteriorate or are lost during freezing and/or storage.

G. Subcontractors. The drug testing laboratory shall perform all work with its own personnel and equipment, unless otherwise authorized by the employer or director of the Office of Workers' Compensation Administration. Subcontractors shall follow all procedures and regulations as set out in these rules.

H. Laboratory Facilities. Laboratories must comply with applicable provisions of any state licensure requirements. Laboratories must be able to perform, at the same facility, screening and/or confirmation tests for each drug or metabolite for which service is offered.

I. Laboratory Personnel

1. The scientific director of the drug testing laboratory shall meet the following criteria. He or she must hold a B.S. in pharmacology, toxicology, or analytical chemistry and have at least two years experience in analytical toxicology (the analysis of biological materials for drugs of abuse) and appropriate training and/or forensic applications of analytic toxicology (court testimony, research and publications in analytic toxicology of drug abuse, etc.). The director is responsible for ensuring that there are sufficient personnel with adequate training and experience to supervise and conduct the work of the drug testing laboratory.

2. A key individual in the laboratory is the certifying scientist (who may also be the laboratory scientific director); this individual reviews the standards, control specimens, and quality control of the data, together with the screening and confirmation test results. After having assured that all results are acceptable, this individual certifies the test results. The certifying scientist must have sound training in the sciences, specific training in the theory and practice of the procedures used, including the recognition of aberrant results, and familiarity with quality control procedures.

3. Supervisors of analysts must possess a B.S. degree in chemistry, or at least the education and experience comparable to a Medical Technologist certified by the American Society of Clinical Pathologists, MT(ASCP), or its equivalent. These individuals, also, must have training in the theory and practice of the procedures used, and understanding of quality control concepts. Periodic verification of their skills must be documented. Other technicians or nontechnical staff must possess the necessary training and skills for the task assigned. Inservice continuing education programs to meet the needs of all laboratory personnel are desirable. Personnel files must include resume of training and experience; certification or license, if any; references; job descriptions; health records; records of performance evaluation and advancement; incident reports; and results of tests for color blindness.

4. Laboratory screening personnel performing initial tests shall comply with personnel requirements to provide reasonable assurance of accuracy of test results.

J. Quality Assurance and Quality Control. Drug testing laboratories shall have a quality assurance program which encompasses all aspects of the testing process: specimen acquisition, chain of custody, security, and reporting of results, in addition to the screening and confirmation of analytical procedures. Quality control procedures will be designed, implemented, and reviewed to monitor the conduct of each step of the process.

K. Documentation. Documentation of all aspects of the testing process must be available. This documentation will be maintained for at least two years and shall include personnel files on analysts, supervisors, directors, and all individuals authorized to have access to specimens; chain of custody documents; quality assurance/quality control records; all test data; reports; performance records on proficiency testing; performance records on accreditation inspections; and hard copies of computer-generated data.

L. Reports. All positive test results, including screening, confirmation, and quality control data must be reviewed by the certifying scientist or laboratory director before a test result is certified as accurate. The report shall identify the drugs/metabolites tested for, whether positive or negative, and the threshold concentration for each.

M. Judicial Proceedings. The laboratory must have qualified personnel available to testify in an administrative or legal proceeding against an employee which is based on a positive drug or alcohol result reported.

La. Admin. Code tit. 40, § I-1507

Promulgated by the Department of Employment and Training, Office of Workers' Compensation, LR 16:853 (October 1990), repromulgated LR 17:774 (August 1991).

AUTHORITY NOTE: Promulgated in accordance with R.S. 23:1081(9).