10 CFR 26.155, Laboratory Personnel

Laboratory personnel

a

(a) Day-to-day management of the HHS-certified laboratory. HHS-certified laboratories shall have a responsible person to assume professional, organizational, educational, and administrative responsibility for the laboratory's drug testing facilities.

(1) This individual shall have documented scientific qualifications in analytical forensic toxicology. Minimum qualifications are as follows:

(i) Certification by the appropriate State as a laboratory director in forensic or clinical laboratory toxicology; or

(ii) A PhD in one of the natural sciences with an adequate undergraduate and graduate education in biology, chemistry, and pharmacology or toxicology; or

(iii) Training and experience comparable to a Ph.D. in one of the natural sciences, such as a medical or scientific degree with additional training and laboratory/research experience in biology, chemistry, and pharmacology or toxicology; and (iv) In addition to the requirements in paragraphs (a)(1)(i) through (a)(1)(iii) of this section, the responsible person shall also have the following minimum qualifications:

(A) Appropriate experience in analytical forensic toxicology including experience with the analysis of biological material for drugs of abuse; and

(B) Appropriate training and/or experience in forensic applications of analytical toxicology (e.g., publications, court testimony, research concerning analytical toxicology of drugs of abuse, or other factors that qualify the individual as an expert witness in forensic toxicology).

(2) This individual shall be engaged in and responsible for the day-to-day management of the testing laboratory, even if another individual has overall responsibility for an entire multi-specialty laboratory.

(3) This individual shall be responsible for ensuring that there are enough personnel with adequate training and experience to supervise and conduct the work of the drug testing laboratory. He or she shall ensure the continued competency of laboratory personnel by documenting their in-service training, reviewing their work performance, and verifying their skills.

(4) This individual shall be responsible for ensuring that the laboratory has a manual of standard operating procedures that are complete, up-to-date, available for personnel performing tests, and followed by those personnel. The procedures must be reviewed, signed, and dated by this responsible person whenever the procedures are first placed into use or changed or when a new individual assumes responsibility for management of the laboratory. This individual shall ensure that copies of all procedures and records of the dates on which they are in effect are maintained. (Specific contents of the procedures are described in § 26.157.)

(5) This individual shall be responsible for maintaining a quality assurance program to assure the proper performance and reporting of all test results; maintaining acceptable analytical performance for all controls and standards; maintaining quality control testing; and assuring and documenting the validity, reliability, accuracy, precision, and performance characteristics of each test and test system.

(6) This individual shall be responsible for taking all remedial actions that may be necessary to maintain satisfactory operation and performance of the laboratory in response to quality control systems not being within performance specifications, including errors in result reporting or in the analysis of performance testing results. This individual shall ensure that test results are not reported until all corrective actions have been taken and he or she can assure that the test results provided are accurate and reliable.

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(b) Certifying scientist. (1) HHS-certified laboratories shall have one or more certifying scientists who review all pertinent data and quality control results to certify the laboratory's test results.

(2) A certifying scientist shall be an individual with at least a bachelor's degree in the chemical or biological sciences, medical technology, or an equivalent field who reviews all pertinent data and quality control results. The individual shall have training and experience in the theory and practice of all methods and procedures used in the laboratory, including a thorough understanding of chain-of-custody procedures, quality control practices, and analytical procedures relevant to the results that the individual certifies. Relevant training and experience must also include the review, interpretation, and reporting of test results; maintenance of chain of custody; and proper remedial action to be taken in response to aberrant test or quality control results, or a determination that test systems are out of control limits.

(3) A laboratory may designate certifying scientists who only certify results that are reported negative and certifying scientists who certify results that are reported both negative and adulterated, substituted, dilute, or invalid.

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(c) Day-to-day operations and supervision of analysts. HHS-certified laboratories shall assign one or more individuals who are responsible for day-to-day operations and supervision of the technical analysts. The designated individual(s) shall have at least a bachelor's degree in the chemical or biological sciences, medical technology, or an equivalent field. The individual(s) shall also have training and experience in the theory and practice of the procedures used in the laboratory, resulting in his or her thorough understanding of quality control practices and procedures; review, interpretation, and reporting of test results; maintenance of the chain of custody; and proper remedial actions to be taken in response to aberrant test or quality control results, or the finding that test systems are out of control limits.

d

(d) Other personnel. Other technicians or nontechnical staff shall have the necessary training and skills for their assigned tasks.

e

(e) Training. HHS-certified laboratories shall make available continuing education programs to meet the needs of laboratory personnel.

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(f) Files. At a minimum, each laboratory personnel file must include a résumé, any professional certification(s) or license(s), a job description, and documentation to show that the individual has been properly trained to perform his or her job.

Federal Register

[[[FR::http://frwebgate.access.gpo.gov/cgi-bin/getpage.cgi?dbname=2008_register&page=17209&position=1%7C 73 FR 17209 Mar. 31, 2008]]]

External Links

[[URL::http://www.nrc.gov/reading-rm/doc-collections/cfr/part026/part026-0155.html%7CNRC website 10 CFR 26.155]]

v t e Code of Federal Regulations
Title 10 Part 26 - FITNESS FOR DUTY PROGRAMS
10 CFR: 1 2 4 5 7 9 10 11 12 13 14 15 16 19 20 21 25 26 30 31 32 33 34 35 36 37 39 40 50 51 52 54 55 60 61 62 63 70 71 72 73 74 75 76 81 95 100 140 150 160 170 171
1, Administrative Provisions, Purpose 3, Scope 4, FFD program applicability to categories of individuals 5, Definitions 7, Interpretations 8, Information collection requirements: OMB approval 9, Specific exemptions 11, Communications 21, Program Elements, Fitness-for-duty program 23, Performance objectives 25, Reserved 27, Written policy and procedures 29, Training 31, Drug and alcohol testing 33, Behavioral observation 35, Employee assistance programs 37, Protection of information 39, Review process for fitness-for-duty policy violations 41, Audits and corrective action 51, Granting and Maintaining Authorization, Applicability 53, General provisions 55, Initial authorization 57, Authorization update 59, Authorization reinstatement 61, Self-disclosure and employment history 63, Suitable inquiry 65, Pre-access drug and alcohol testing 67, Random drug and alcohol testing of individuals who have applied for authorization 69, Authorization with potentially disqualifying fitness-for-duty information 71, Maintaining authorization 73, Management Actions and Sanctions To Be Imposed, Applicability 75, Sanctions 77, Management actions regarding possible impairment 81, Collecting Specimens for Testing, Purpose and applicability 83, Specimens to be collected 85, Collector qualifications and responsibilities 87, Collection sites 89, Preparing to collect specimens for testing 91, Acceptable devices for conducting initial and confirmatory tests for alcohol and methods of use 93, Preparing for alcohol testing 95, Conducting an initial test for alcohol using a breath specimen 97, Conducting an initial test for alcohol using a specimen of oral fluids 99, Determining the need for a confirmatory test for alcohol 101, Conducting a confirmatory test for alcohol 103, Determining a confirmed positive test result for alcohol 105, Preparing for urine collection 107, Collecting a urine specimen 109, Urine specimen quantity 111, Checking the acceptability of the urine specimen 113, Splitting the urine specimen 115, Collecting a urine specimen under direct observation 117, Preparing urine specimens for storage and shipping 119, Determining "shy" bladder 121, Licensee Testing Facilities, Purpose 123, Testing facility capabilities 125, Licensee testing facility personnel 127, Procedures 129, Assuring specimen security, chain of custody, and preservation 131, Cutoff levels for validity screening and initial validity tests 133, Cutoff levels for drugs and drug metabolites 135, Split specimens 137, Quality assurance and quality control 139, Reporting initial validity and drug test results 151, Laboratories Certified by the Department of Health and Human Services, Purpose 153, Using certified laboratories for testing urine specimens 155, Laboratory personnel 157, Procedures 159, Assuring specimen security, chain of custody, and preservation 161, Cutoff levels for validity testing 163, Cutoff levels for drugs and drug metabolites 165, Testing split specimens and retesting single specimens 167, Quality assurance and quality control 168, Blind performance testing 169, Reporting Results 181, Determining Fitness-for-Duty Policy Violations and Determining Fitness, Purpose 183, Medical review officer 185, Determining a fitness-for-duty policy violation 187, Substance abuse expert 189, Determination of fitness 201, Managing Fatigue, Applicability 203, General provisions 205, Work hours 207, Waivers and exceptions 209, Self-declarations 211, Fatigue assessments 401, FFD Programs for Construction, General 403, Written policy and procedures 405, Drug and alcohol testing 406, Fitness monitoring 407, Behavioral observation 409, Sanctions 411, Protection of information 413, Review process 415, Audits 417, Recordkeeping and reporting 419, Suitability and fitness evaluations 709, Recordkeeping and Reporting Requirements, Applicability 711, General provisions 713, Recordkeeping requirements for licensees and other entities 715, Recordkeeping requirements for collection sites, licensee testing facilities, and laboratories certified by the Department of Health and Human Services further results Appendices:

10 CFR 26.155, Laboratory Personnel

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10 CFR 26.155, Laboratory Personnel

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