(5) Analytical methods and procedures;
(6) Equipment and maintenance programs;
(7) Personnel training;
(8) Reporting procedures; and
(9) Computers, software, laboratory information management systems
(b) All procedures in the SOP manual must be in compliance with these Guidelines and NLCP Program Documents.
(c) A copy of all procedures that have been replaced or revised and the dates on which they were in effect must be maintained to allow the laboratory to retrieve the procedures that were used to test a specimen.
11.2 What qualifications must the laboratory?s responsible person (RP) have?
A certified laboratory must have at least one individual who can assume the professional, organizational, educational, and administrative responsibilities for the entire drug testing facility. The minimum qualifications for the RP are as follows:
(a) Certified as a laboratory director by the State in forensic or clinical laboratory toxicology; or have a Ph.D. in one of the natural sciences with an adequate undergraduate and graduate education in biology, chemistry, pharmacology, or toxicology; or have training and experience comparable to a Ph.D. in one of the natural sciences with additional training and laboratory/research experience in biology, chemistry, pharmacology, or toxicology; and
(b) Have appropriate experience in analytical forensic toxicology with emphasis on the collection and analysis of biological specimens for drugs of abuse; and
(c) Have 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 which qualify the individual as an expert witness in forensic toxicology.
11.3 What are the responsibilities of the RP?
The RP must fulfill the following responsibilities:
(a) Manage the day-to-day operations of the drug testing laboratory even where another individual has overall responsibility for an entire multi-specialty laboratory.
(b) Ensure that there are enough personnel with adequate training and experience to supervise and conduct the work of the drug testing laboratory. The RP must ensure the continued competency of laboratory personnel by documenting their in-service training, reviewing their work performance, and verifying their skills.
(c) Maintain a complete, current SOP manual that is available for personnel performing tests, and followed by those personnel. The SOP manual must be reviewed, signed, and dated by the RP whenever procedures are first placed into use or changed or when a new individual assumes responsibility for management of the drug testing laboratory.
(d) Maintain a quality assurance program to assure the proper performance and reporting of all test results; monitor acceptable analytical performance for all controls and standards; monitor quality control testing; document the validity, reliability, accuracy, precision, and performance characteristics of each test and test system.
(e) Implement all remedial actions necessary to maintain satisfactory operation and performance of the laboratory in response to quality control systems not being within performance specifications, errors in result reporting or in analysis of performance testing results. This individual must ensure that sample results are not reported until all corrective actions have been taken and he or she can assure that the results provided are accurate and reliable.
(f) Qualify as a certifying scientist for both initial and confirmatory test results.
11.4 What qualifications and training must an individual have to certify a drug test result that is reported by a laboratory?
(a) A certifying scientist (CS) must have the following qualifications:
(1) A bachelor’s degree in the chemical or biological sciences, medical technology, or equivalent;
(2) Training and experience in the analytical methods and procedures used by the laboratory that are relevant to the results that the individual certifies; and
(3) Training and experience in reviewing and reporting test results, maintenance of chain of custody, and understanding proper remedial action in response to problems that may arise.
(b) A laboratory must have at least one individual who is designated as a CS.
(c) There are two types of certifying scientists:
(1) A negative CS who is qualified to certify only results that are negative on the initial test; and
(2) A CS who is qualified to certify results for both initial and confirmatory test results.
11.5 What qualifications and training must other laboratory personnel have?
(a) All laboratory staff (e.g., technicians, administrative staff) must have the appropriate training and skills for the tasks assigned.
(b) Each individual working in a certified laboratory must be properly trained before he or she is permitted to work independently in any area of the laboratory.
(c) The training file for each individual must include, at a minimum, resumes, documentation of training provided, and any applicable professional certifications/licenses. Training files may be maintained separate from personnel files.
11.6 What security measures must a laboratory maintain?
(a) A laboratory must control access to the drug testing facility and ensure that no unauthorized individual can gain access to specimens, aliquots, or records.
(b) A laboratory must maintain a record that documents the dates, time of entry and exit, and purpose of entry of authorized visitors accessing secured areas.
(c) With the exception of personnel authorized to conduct inspections on behalf of Federal, state, or other accrediting agencies for which the laboratory is testing specimens or on behalf of the Secretary or emergency personnel (e.g., firefighters and medical rescue teams), all authorized visitors must be escorted at all times.
11.7 How must a laboratory handle a specimen or an aliquot?
(a) A laboratory must use chain of custody procedures to document the receipt, handling, and transfer of a specimen or an aliquot throughout the testing process and until final disposition.
(b) Chain of custody must be documented by using either hard copy procedures or electronic procedures.
(c) Chain of custody documentation must be completed at the time of the transaction.
11.8 What is an initial test?
(a) An initial test is a test used to differentiate a “negative” specimen from those that require further testing.
(b) An initial test may include, but is not limited to, the following techniques: immunoassay or chromatographic separation coupled with an appropriate detector.
(c) An initial test must be validated by the laboratory before it is used to test donor specimens.
11.9 What must a laboratory do to validate an initial test method?
(a) The validation procedure must demonstrate:
(1) The ability to differentiate positive and negative samples;
(2) The performance of the test around the cutoff concentration; and
(3) The performance of the test results at several concentrations between 0 and 150 percent of the cutoff concentration.
(b) A laboratory may conduct a second initial test prior to the confirmatory test. If the laboratory uses a second initial test, the second initial test is subject to the same requirements as the first initial test.
11.10 Why must the initial test be calibrated?
The initial test must be calibrated to ensure and document the linearity of the assay method over time in the concentration area of the cutoff.
11.11 What are the quality control requirements when conducting an initial test?
(a) Each batch of specimens must contain the following types of QC samples:
(1) At least one control certified to contain no drug or metabolite;
(2) At least one control that has the concentration of the drug or metabolite at 25 percent above the cutoff concentration;
(3) At least one control that has the concentration of the drug or metabolite at 25 percent below the cutoff concentration; and
(4) At least one blind control (or a minimum of 1 percent) inserted to appear as a donor specimen to the laboratory analysts.
(b) At least 10 percent of the batch must be calibrators and controls.
(c) A laboratory must establish a procedure to ensure that any carryover that might occur between aliquots during the initial testing is detectable and corrected.
11.12 What is a confirmatory test?
(a) A confirmatory test is an analytical procedure performed on a separate aliquot of the specimen to identify the presence of a specific drug or metabolite.
(b) The procedure used must combine chromatographic separation and mass spectrometric identification in the same procedure (e.g., GC/MS, LC/MS, GC/MS/MS, LC/MS/MS).
(c) A confirmatory test must be validated before it can be used to test specimens.
11.13 What must a laboratory do to validate a confirmatory test method?
To validate a confirmatory test, the laboratory must demonstrate:
(1) The linear range of the analysis;
(2) The limit of detection;
(3) The limit of quantitation;
(4) The accuracy and precision at the cutoff concentration;
(5) The accuracy and precision at 40 percent of the cutoff concentration; and
(6) The potential for interfering substances.
11.14 Why must the confirmatory test be calibrated?
The confirmatory test must be calibrated to ensure and document the linearity of the assay method over time in the concentration area of the cutoff.
11.15 What are the quality control requirements when conducting a confirmatory test?
(a) Each batch of specimens must contain the following types of QC samples:
(1) A single-point calibrator at the cutoff;
(2) At least one control certified to contain no drug or metabolite;
(3) At least one control that has the concentration of the drug or metabolite at 25 percent above the cutoff concentration;
(4) At least one control that has the concentration of the drug or metabolite at 40 percent of the cutoff concentration; and
(5) At least one control in every batch must be blind.
(b) The linear range, limit of detection, and limit of quantitation must be documented and periodically re-evaluated for each confirmatory test.
(c) A laboratory must establish a procedure to ensure that any carryover that might occur between aliquots in the confirmatory batch is detectable and corrected.
11.16 Is a laboratory allowed to conduct any additional tests on a specimen?
(a) A laboratory is permitted to conduct additional tests to determine the validity of a specimen.
(b) The validity tests that may be used will depend on the type of specimen being tested.
(c) Specific guidance on conducting validity tests is described in NLCP program documents.
(d) No further testing of a negative specimen for drugs is permitted and the specimen must either be discarded or pooled for use in the laboratory’s internal quality control program.
11.17 What are the requirements for a laboratory to report the test result for a specimen?
(a) The laboratory must report the test result within 5 (on average) working days after receipt of the specimen.
(b) A specimen identified as positive for a drug or metabolite on an initial test must be confirmed positive before a positive result can be reported to the MRO.
(c) The laboratory may report only that a specimen is positive without including the concentration of the drug unless the MRO specifically requests the concentration.
(d) The laboratory can only report a test result to an MRO.
(e) The laboratory may transmit results to the MRO by various electronic means (e.g., facsimile, computer) in a manner designed to ensure the confidentiality of the information, the security of the data transmission, and limit access to any data transmission, storage, and retrieval system.
(f) A hard copy of the CCF must be sent to the MRO when the result is reported as either positive for a specific drug, adulterated, substituted, rejected for testing, or invalid result.
(g) A facsimile or electronic report is sufficient to report a negative result.
(h) A test result may not be provided telephonically; however, the MRO may call the laboratory to discuss a result.
(i) The laboratory may also send the MRO a separate laboratory report that gives additional information (e.g., cutoffs) for the specimen tested.
(j) A laboratory must use its own form to report the results for the retesting of a single specimen.
11.18 How long must a laboratory retain a specimen?
(a) A laboratory must retain a specimen that was reported either positive, adulterated, substituted, diluted, rejected for testing, or invalid result for a minimum of 1 year.
(b) A retained specimen must be kept in a secured location that is appropriate for that type of specimen (e.g., frozen storage for urine) to ensure its availability for any necessary retesting during an administrative or judicial proceeding.
(c) Within the 1-year storage period, a Federal agency may request a laboratory to retain a specimen for an additional period of time. If no such request is received, a specimen may be discarded.
11.19 How long must a laboratory retain records?
(a) A laboratory must retain all records generated to support test results for at least 2 years.
(b) A Federal agency may request the laboratory to maintain records associated with a particular specimen under legal challenge for an indefinite period.
11.20 Can a laboratory store records electronically?
(TO BE DETERMINED)
11.21 What summary report must a laboratory provide to a Federal agency?
(a) A laboratory must provide a semi-annual summary report to a Federal agency for which it tests specimens, but must not include any personal identifying information for the specimens tested.
(b) The summary report must contain the following information:
(1) Total number of specimens reported
(2) Number of specimens grouped by reason for test
A. Random
B. All others combined
(3) Number of specimens rejected for testing
(4) Number of specimens reported:
(a) Positive for each drug
(b) Adulterated
(c) Substituted
NOTE: We are currently evaluating the need for this report.
11.22 What information is available to the donor?
(a) A Federal employee who is the subject of a drug test may, upon written request through the Agency and the MRO, have access to a documentation
46c
(a) A notice is published in the Federal Register listing the name and address of any certified laboratory that has its certification suspended or revoked.
(b) The notice will state the reason for the immediate suspension or revocation.
(c) A notice is published in the Federal Register when the suspension is lifted.