A. COLLECTION SITE

(Permanent/temporary facility used to collect a specimen)

1. Preparation of Collection Site

An appropriate site can be established to permit the collection of a valid specimen and ensure confidentiality

Restrict access to collection site personnel and restrict access to specimens, collection materials, supplies, and records

Facility constructed to ensure the privacy of the donor during specimen collection

Capability to observe donor during specimen collection if there is any suspicion that the donor may attempt to tamper with or adulterate the specimen

B. COLLECTOR

(Individual who obtains the specimen from the donor)

Can document appropriate training has been given to the collector

A certification program can be established to ensure that a collector is fully trained to properly collect and handle the specimen

C. COLLECTION DEVICE

Allows for collection of a valid specimen, safe handling of specimen, and integrity and identity of specimen during transport

Able to prevent/indicate unauthorized access to specimen

Container/kit cleared by FDA

Device alters or affects the specimen/drug/metabolite

D. SPECIMEN

(Hair, saliva, sweat, urine)

Identify a specific body site to collect valid specimen

Volume/size of specimen is sufficient to conduct several tests

Single specimen can be divided into two identical (split) specimens

Effects of environment, storage, and shipment on specimen have been evaluated

E. COLLECTION PROCEDURE

(Procedure used to collect specimen)

Procedure to ensure identification of donor

Procedure to ensure that a valid specimen can be collected

Can document the handling of the specimen from the time that the donor provides the specimen until the collector sends the specimen to the laboratory

Standard form can be designed to properly document all essential information (i.e, specimen custody, validity, and identity)

Procedure/tests available to ensure that a valid specimen is provided by the donor

Procedures to prevent donor from tampering with or adulteration the specimen

Can be packaged to protect specimen from damage/loss during transit

F. ON-SITE TESTING

(Refers to initial tests of urine specimens performed at collection site)

The test kit has been cleared by the FDA

The test kit has documented specificity for the drug class of interest

Procedure allows appropriate documentation of specimen collection (see specimen collection A, B, C, D, and E)

Procedure allows documenting the test result and chain of custody during testing

A procedure can be established to document test result

Uses HHS testing levels

Detects HHS target analytes

Test provides an objective discrimination between positive and negative results

Controls available to ensure on-site test is working correctly

Procedure available to train and certify analysts

Individual conducting on-site test is unable to determine donor identity

Ability to have results confirmed by a second analyst on-site

Ability to determine if the specimen has been adulterated and ability to determine if the test is effected by the adulterant

G. LABORATORY TESTING

Can appropriate criteria be established to determine the acceptability of specimens received by the laboratories

Specimens can be stored to ensure that analytes are not affected by environmental or physical factors during normal handling procedures

Tests are available to determine the presence of adulterants and/or if the specimen is a valid specimen

(First test conducted to identify presumptive positive specimens for each drug class tested)

a. FDA cleared test

The test kit should be cleared by the FDA as a diagnostic medical device

b. Detect HHS target analytes

The test kit detects the target analyte

c. Use HHS established testing levels

The test kit performance has been optimized around the HHS testing cutoff level

d. Acceptable performance around the cutoff

Test kit performance around the cutoff is acceptable, i.e., samples 25% above and below the cutoff can be discriminated and are correctly reported as positive or negative

e. Ability to repeat initial test

Procedure allows the initial test to be repeated

(A chemical test using a principle differing from the initial test that can uniquely identify a specific analyte)

a. Uses mass spectrometry for identification and quantitation

The technique provides a positive identification of a specific analyte (if present) and an accurate quantitative result of the analyte

b. Use HHS established testing levels

Capable of calibrating the procedure around the HHS testing cutoff level

c. Acceptable performance around the cutoff

Procedure is linear around the cutoff

The cutoff can be related to drug use while minimizing potential endogenous, chemical, and electronic interferences

An internal quality control program can be established that includes calibrators, drug-free controls, and blind samples

H. QUALITY CONTROL AND QUALITY ASSURANCE

A certification program can be established for laboratories conducting the testing

Performance testing samples can be prepared that challenge the ability of the laboratories to identify analytes and determine their concentration

An inspection program can be established to inspect and evaluate all aspects of a laboratory

Possible to submit negative/positive samples as if they were donor specimens

I. REPORTING

(Refers to the laboratory reporting results to the Medical Review Officer)

A comprehensive final review can be conducted by one individual who reviews the technical data, chain of custody, and all other records associated with the specimens before the results are reported to the MRO

Laboratory report can list results for each specific drug detected

There is a reasonable turn-around-time to report results and results are reported such that the identity of the donor and the results are kept confidential

A standard report form can be used to ensure that results are reported as required

J. MEDICAL REVIEW OFFICER

(Refers to a physician reviewing a laboratory result, discussing positive results with donor, and making a final determination regarding substance abuse)

Scientific information is available to allow an MRO to properly interpret a positive test result

Alternative medical explanations been properly described/established

Appropriate training is available to ensure that MROs can properly interpret drug test results

K. MISCELLANEOUS ISSUES

Concentration of drug/metabolite related to the time and dose when drug use occurred

Specimen may contain drug from external exposure rather than through metabolic process