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been completed. Aliquots and the lab- drug. All confirmations shall be by oratory's chain of custody forms shall quantitative analysis. Concentrations be used by laboratory personnel for that exceed the linear region of the conducting initial and confirmatory standard curve shall be documented in tests.

the laboratory record as “greater than (c) Short-term refrigerated storage. highest standard curve value.” Specimens that do not receive an ini. tial test within 7 days of arrival at the

Confirmatory test laboratory shall be placed in secure re

cutoff levels (ng/ frigeration units. Temperatures shall not exceed 6°C. Emergency power equipment shall be available in case of Marijuana metabolite

Cocaine metabolite?

150 prolonged power failure.

Opiates: (d) Specimen processing. Laboratory Morphine. facilities for urine drug testing will Codeine..

Phencyclidine. normally process specimens by group

Amphetamines: ing them into batches. The number of

Amphetamine.. specimens in each batch may vary sig- Methamphetamine. nificantly depending on the size of the

Delta-9-tetrahydrocannabinol-9-carboxylic acid. laboratory and its workload. When

2 Benzoylecgonine. conducting either initial or confirmatory tests, every batch shall contain an (2) These cutoff levels are subject to appropriate number of standards for change by the Department of Health calibrating the instrumentation and a and Human Services as advances in minimum of 10 percent controls. Both technology or other considerations quality control and blind performance

warrant identification of these subtest samples shall appear as ordinary stances at other concentrations. samples to laboratory analysts.

(g) Reporting results. (1) The labora(e) Initial test. (1) The initial test tory shall report test results to the shall use an immunoassay which employer's Medical Review Officer meets the requirements of the Food within an average of 5 working days and Drug Administration for commer- after receipt of the specimen by the cial distribution. The following initial laboratory. Before any test result is recutoff levels shall be used when ported (the results of initial tests, conscreening specimens to determine firmatory tests, or quality control whether they are negative for these data), it shall be reviewed and the test five drugs or classes of drugs:

certified as an accurate report by the

responsible individual. The report Initial test cutoff

shall identify the drugs/metabolites levels (ng/ml)

tested for, whether positive or nega

tive, the specimen number assigned by Marijuana metabolites...

the employer, and the drug testing Cocaine metabolites

300

laboratory specimen identification Opiate metabolites. Phencyclidine....

number (accession number). Amphetamines..

1,000 (2) The laboratory shall report as

negative all specimens that are nega25 ng/ml if immunoassay specific for free morphine.

tive on the initial test or negative on (2) These cutoff levels are subject to the confirmatory test. Only specimens change by the Department of Health confirmed positive shall be reported and Human Services as advances in positive for a specific drug. technology or other considerations (3) The Medical Review Officer may warrant identification of these sub- request from the laboratory and the stances at other concentrations.

laboratory shall provide quantitation (f) Confirmatory test. (1) All speci- of test results. The MRO shall report mens identified as positive on the ini- whether the test is positive or negatial test shall be confirmed using gas tive, and may report the drug(s) for chromatography/mass spectrometry which there was a positive test, but (GC/MS) techniques at the cutoff shall not disclose the quantitation of levels listed in this paragraph for each test results to the employer. Provided,

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*300

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that the MRO may reveal the quanti- (A) Number of specimens received for contation of a positive test result to the

firmation; employer, the employee, or the deci

(B) Number of specimens confirmed posisionmaker in a lawsuit, grievance, or

tive for: other proceeding initiated by or on

Marijuana metabolite behalf of the employee and arising

Cocaine metabolite from a verified positive drug test.

Morphine, codeine (4) The laboratory may transmit re

Phencyclidine sults to the Medical Review Officer by

Amphetamine

Methamphetamine various electronic means (for example, teleprinters, facsimile, or computer) in Monthly reports shall not include data a manner designed to ensure confiden- from which it is reasonably likely that tiality of the information. Results may information about individuals' tests not be provided verbally by telephone. can be readily inferred. If necessary, The laboratory and employer must in order to prevent the disclosure of ensure the security of the data trans- such data, the laboratory shall not mission and limit access to any data send a report until data are sufficienttransmission, storage, and retrieval ly aggregated to make such an infersystem.

ence unlikely. In any month in which (5) The laboratory shall send only to a report is withheld for this reason, the Medical Review Officer the origi- the laboratory will so inform the emnal or a certified true copy of the drug ployer in writing. testing custody and control form (part (7) The laboratory shall make avail2), which, in the case of a report posi- able copies of all analytical results for tive for drug use, shall be signed (after

employer drug testing programs when the required certification block) by

requested by DOT or any DOT agency the individual responsible for day-to

with regulatory authority over the emday management of the drug testing ployer. laboratory or the individual responsi

(8) Unless otherwise instructed by ble for attesting to the validity of the

the employer in writing, all records test reports, and attached to which

pertaining to a given urine specimen shall be a copy of the test report. shall be retained by the drug testing (6) The laboratory shall provide to

laboratory for a minimum of 2 years. the employer official responsible for

(h) Long-term storage. Long-term coordination of the drug testing pro

frozen storage (-20°C or less) ensures gram a monthly statistical summary

that positive urine specimens will be of urinalysis testing of the employer's

available for any necessary retest employees and shall not include in the

during administrative or disciplinary summary any personal identifying in

proceedings. Drug testing laboratories formation. Initial and confirmation

shall retain and place in properly sedata shall be included from test re

cured long-term frozen storage for a sults reported within that month. Nor

minimum of 1 year all specimens conmally this summary shall be forward

firmed positive, in their original laed by registered or certified mail not

beled specimen bottles. Within this 1more than 14 calendar days after the

year period, an employer (or other end of the month covered by the sum

person designated in a DOT agency mary. The summary shall contain the

regulation) may request the laboratofollowing information:

ry to retain the specimen for an addi. (i) Initial Testing;

tional period of time, but if no such re(A) Number of specimens received;

quest is received the laboratory may (B) Number of specimens reported out;

discard the specimen after the end of and

1 year, except that the laboratory (C) Number of specimens screened posi

shall be required to maintain any tive for:

specimens known to be under legal Marijuana metabolites Cocaine metabolites

challenge for an indefinite period. Opiate metabolites

(i) Retesting specimens. Because Phencyclidine

some analytes deteriorate or are lost Amphetamine

during freezing and/or storage, quan(ii) Confirmatory Testing:

titation for a retest is not subject to a

specific cutoff requirement but must shall include personnel files on all inprovide data sufficient to confirm the dividuals authorized to have access to presence of the drug or metabolite. specimens; chain of custody docu

(j) Subcontracting. Drug testing lab- ments; quality assurance/quality conoratories shall not subcontract and trol records; procedure manuals; all shall perform all work with their own test data (including calibration curves personnel and equipment. The labora- and any calculations used in determintory must be capable of performing ing test results); reports; performance testing for the five classes of drugs records on performance testing; per(marijuana, cocaine, opiates, phency- formance on certification inspections; clidine and amphetamines) using the and hard copies of computer-generatinitial immunoassay and confirmatory ed data. The laboratory shall maintain GC/MS methods specified in this part. documents for any specimen known to This paragraph does not prohibit sub

be under legal challenge for an indeficontracting of laboratory analysis if nite period. specimens are sent directly from the

(n) Additional requirements for cercollection site to the subcontractor,

tified laboratories.-(1) Procedure the subcontractor is a laboratory certi

manual. Each laboratory shall have a fied by DHHS as required in this part,

procedure manual which includes the the subcontractor performs all analy

principles of each test preparation of sis and provides storage required

reagents, standards and controls, caliunder this part, and the subcontractor

bration procedures, derivation of reis responsible to the employer for com

sults, linearity of methods, sensitivity pliance with this part and applicable

of methods, cutoff values, mechanisms DOT agency regulations as if it were

for reporting results, controls criteria the prime contractor.

for unacceptable specimens and re(k) Laboratory facilities. (1) Labora

sults, remedial actions to be taken tory facilities shall comply with appli

when the test systems are outside of cable provisions of any State licensing

acceptable limits, reagents and expirarequirements.

tion dates, and references. Copies of (2) Laboratories certified in accord

all procedures and dates on which ance with DHHS Guidelines shall

they are in effect shall be maintained have the capability, at the same labo

as part of the manual. ratory premises, of performing initial and confirmatory tests for each drug

(2) Standards and controls. Laboraor metabolite for which service is of

tory standards shall be prepared with

pure drug standards which are properfered. (1) Inspections. The Secretary, a

ly labeled as to content and concentraDOT agency, any employer utilizing

tion. The standards shall be labeled

with the following dates: when rethe laboratory, DHHS or any organization performing laboratory certifica

ceived; when prepared or opened; tion on behalf of DHHS reserves the

when placed in service; and expiration

date. right to inspect the laboratory at any time. Employer contracts with labora

(3) Instruments and equipment. (i) tories for drug testing, as well as con

Volumetric pipettes and measuring detracts for collection site services, shall

vices shall be certified for accuracy or permit the employer and the DOT

be checked by gravimetric, colorimetagency of jurisdiction (directly or ric, or other verification procedure. through an agent) to conduct unan- Automatic pipettes and dilutors shall nounced inspections.

be checked for accuracy and reproduc(m) Documentation. The drug test

ibility before being placed in service ing laboratories shall maintain and and checked periodically thereafter. make available for at least 2 years doc

(ii) There shall be written proceumentation of all aspects of the test- dures for instrument set-up and ing process. This 2 year period may be normal operation, a schedule for extended upon written notification by checking critical operating charactera DOT agency or by any employer for istics for all instruments, tolerance which laboratory services are being limits for acceptable function checks provided. The required documentation and instructions for major trouble

shooting and repair. Records shall be available on preventive maintenance.

(4) Remedial actions. There shall be written procedures for the actions to be taken when systems are out of acceptable limits or errors are detected. There shall be documentation that these procedures are followed and that all necessary corrective actions are taken. There shall also be in place systems to verify all stages of testing and reporting and documentation that these procedures are followed.

(5) Personnel available to testify at proceedings. A laboratory shall have qualified personnel available to testify in an administrative or disciplinary proceeding against an employee when that proceeding is based on positive urinalysis results reported by the laboratory.

$ 40.31 Quality assurance and quality con

trol. (a) General. Drug testing laboratories shall have a quality assurance program which encompasses all aspects of the testing process including but not limited to specimen acquisition, chain of custody security and reporting of results, initial and confirmatory testing and validation of analytical procedures. Quality assurance procedures shall be designed, implemented and reviewed to monitor the conduct of each step of the process of testing for drugs.

(b) Laboratory quality control requirements for initial tests. Each analytical run of specimens to be screened shall include:

(1) Urine specimens certified to contain no drug;

(2) Urine specimens fortified with known standards; and

(3) Positive controls with the drug or metabolite at or near the cutoff level.

In addition, with each batch of samples a sufficient number of standards shall be included to ensure and document the linearity of the assay method over time in the concentration area of the cutoff. After acceptable values are obtained for the known standards, those values will be used to calculate sample data. Implementation of procedures to ensure the carryover does not contaminate the testing of an individual's specimen shall be docu

mented. A minimum of 10 percent of all test samples shall be quality control specimens. Laboratory quality control samples, prepared from spiked urine samples of determined concentration shall be included in the run and should appear as normal samples to laboratory analysts. One percent of each run, with a minimum of at least one sample, shall be the laboratory's own quality control samples.

(c) Laboratory quality control requirements for confirmation tests. Each analytical run of specimens to be confirmed shall include:

(1) Urine specimens certified to contain no drug;

(2) Urine specimens fortified with known standards; and

(3) Positive controls with the drug or metabolite at or near the cutoff level. The linearity and precision of the method shall be periodically documented. Implementation of procedures to ensure that carryover does not contaminate the testing of an individual's specimen shall also be documented.

(d) Employer blind performance test procedures.

(1) Each employer covered by DOT agency drug testing regulations shall use blind testing quality control procedures as provided in this paragraph.

(2) Each employer shall submit three blind performance test specimens for each 100 employee specimens it submits, up to a maximum of 100 blind performance test specimens submitted per quarter. A DOT agency may increase this per quarter maximum number of samples if doing so is necessary to ensure adequate quality control of employers or consortiums with very large numbers of employees.

(3) For employers with 2000 or more covered employees, approximately 80 percent of the blind performance test samples shall be blank (i.e., containing no drug or otherwise as approved by a DOT agency) and the remaining samples shall be positive for one or more drugs per sample in a distribution such that all the drugs to be tested are included in approximately equal frequencies of challenge. The positive samples shall be spiked only with those drugs for which the employer is testing. This paragraph shall not be

construed to prohibit spiking of other laboratory to submit all quality con(potentially interfering) compounds, trol data from the batch of specimens as technically appropriate, in order to which included the false positive speciverify the specificity of a particular men to the DOT agency concerned. In assay.

addition, the laboratory shall retest all (4) Employers with fewer than 2000 specimens analyzed positive for that covered employees may submit blind drug or metabolite from the time of performance test specimens as provid- final resolution of the error back to ed in paragraph (d)(3) of this section. the time of the last satisfactory perSuch employers may also submit only formance test cycle. This retesting blank samples or may submit two sep- shall be documented by a statement arately labeled portions of a specimen signed by the individual responsible from the same non-covered employee. for day-to-day management of the lab

(5) Consortiums shall be responsible oratory's urine drug testing. The DOT for the submission of blind samples on agency concerned may require an onbehalf of their members. The blind site review of the laboratory which sampling rate shall apply to the total

may be conducted unannounced number of samples submitted by the during any hours of operation of the consortium.

laboratory. Based on information pro(6) The DOT agency concerned shall

vided by the DOT agency, DHHS has investigate, or shall refer to DHHS for

the option of revoking or suspending investigation, any unsatisfactory per- the laboratory's certification or recomformance testing result and, based on

mending that no further action be this investigation, the laboratory shall

taken if the case is one of less serious take action to correct the cause of the

error in which corrective action has alunsatisfactory performance test result.

ready been taken, thus reasonably asA record shall be made of the investi

suring that the error will not occur gative findings and the corrective

again. action taken by the laboratory, and that record shall be dated and signed 8 40.33 Reporting and review of results. by the individual responsible for the

(a) Medical review officer shall day-to-day management and operation

review confirmed positive results. (1) of the drug testing laboratory. Then

An essential part of the drug testing the DOT agency shall send the document to the employer as a report of

program is the final review of conthe unsatisfactory performance test

firmed positive results from the laboing incident. The DOT agency shall

ratory. A positive test result does not ensure notification of the finding to

automatically identify an employee/ DHHS.

applicant as having used drugs in vio(7) Should a false positive error

lation of a DOT agency regulation. An occur on a blind performance test

individual with a detailed knowledge specimen and the error is determined

of possible alternate medical explanato be an administrative error (clerical,

tions is essential to the review of resample mixup, etc.), the employer

sults. This review shall be performed shall promptly notify the DOT agency

by the Medical Review Officer (MRO) concerned. The DOT agency and the prior to the transmission of the results employer shall require the laboratory to employer administrative officials. to take corrective action to minimize

The MRO review shall include review the occurrence of the particular error

of the chain of custody to ensure that in the future, and, if there is reason to

it is complete and sufficient on its believe the error could have been sys

face. temic, the DOT agency may also re

(2) The duties of the MRO with require review and reanalysis of previ- spect to negative results are purely adously run specimens.

ministrative. (8) Should a false positive error (b) Medical review officer-qualificaoccur on a blind performance test tions and responsibilities. (1) The specimen and the error is determined MRO shall be a licensed physician to be a technical or methodological with knowledge of substance abuse error, the employer shall instruct the disorders and may be an employee of a

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