6.1 What form is used to document a specimen collection?
(a) An Office of Management and Budget (OMB) approved Federal Drug Testing Custody and Control Form (CCF) must be used to document the collection of a specimen at the collection site.
(b) The form is used to document chain of custody from the time a donor gives the specimen to the collector until the specimen is received for testing.
(c) The CCF used for each type of specimen collected is available from a number of different sources. A sample of the OMB approved CCF for each type of specimen is available at the following website:
(d) Federal agencies and employers regulated by the Department of Transportation (DOT) are required to use the OMB approved Federal CCF for their workplace drug testing programs.
6.2 What happens if an approved form is not available or is not used?
(a) When the collector either by mistake or as the only means to conduct a test under difficult circumstances (e.g., post accident test with insufficient time to obtain the CCF) uses a non-Federal form for a regulated collection, the use of a non-Federal form is not a reason for the laboratory to reject the specimen for testing or for the MRO to cancel the test.
(b) If the testing facility or the MRO discovers the use of the incorrect form, a signed statement must be obtained from the collector stating the reason why the Federal CCF was not used for the regulated collection.
Subpart G – Collection Device
7.1 What is a collection device?
(a) A collection device is considered to be the following for each type of specimen collected:
(1) For urine, it is the single-use plastic specimen container and/or bottle.
(2) For hair, it is the foil and single-use plastic bag in which the hair sample is placed.
(3) For oral fluid, it is the applicator, pad, or aspirator placed in the oral cavity.
(4) For sweat, it is the patch that is placed on the skin.
(b) A collection device must not affect or alter the specimen collected. The supplier of a collection device must evaluate the device to ensure that it does not affect the specimen collected.
(c) A collection device must have the capability of being sealed by the collector to prevent unauthorized access to the specimen while at the collection site.
7.2 Must the collection device be cleared by the FDA?
(a) If the collection device is a unique and integral part of the collection procedure and the analytical testing procedure, it must be cleared by the FDA as a medical device.
(b) Single-use items (such as, plastic bottles, plastic bags, foil) are not unique collection devices and, therefore, are not required to be cleared by the FDA.
(c) The sweat patch (sweat) and applicator, pad, or aspirator (oral fluid) are unique and integral to collecting a valid specimen and must be FDA cleared.
Subpart H – Specimen Collection Procedure
8.1 What must the collector do before starting the collection procedure?
The collector must do the following before starting the collection procedure:
(a) Verify the donor?s identification;
(b) Provide your identification to the donor if the donor asks;
(c) Explain the basic collection procedure to the donor;
(d) Request the donor to read the instructions on the back of the CCF; and
(e) Answer any questions the donor may have regarding the collection procedure.
8.2 What are the basic requirements for collecting any type of specimen?
The basic requirements are as follows:
(a) The donor removes any unnecessary outer garments (such as, a coat or jacket).
(b) The donor washes and dries his or her hands prior to handling the collection device. After washing hands, the donor must remain in the presence of the collector and must not have access to anything that could be used to affect the specimen.
(c) The collector and donor observe the selection and opening of the collection device used to collect the specimen.
(d) After a specimen is collected, the collector inspects the specimen for signs of tampering.
(e) A specimen suspected of being tampered with is sent to the laboratory for testing.
(f) The collector must get permission to immediately collect another specimen when a tampered specimen is collected. This second specimen must also be sent to the laboratory.
(g) The collector and donor must keep the specimen in view at all times prior to sealing the collection device.
(h) A tamper-evident label/seal must be used to secure the collection device.
(i) The donor must initial the label and the collector must date the label after it is used to secure the collection device.
(j) The collector must complete the CCF and distribute each copy as required.
8.3 Where can I find the collection procedure for each type of specimen?
(a) A complete description of the collection procedure used to collect each type of specimen is in the HHS Specimen Collection Handbook for Federal Workplace Drug Testing Programs.
(b) The handbook is available on the following website:
Subpart I – National Laboratory Certification Program
9.1 What is the National Laboratory Certification Program (NLCP)?
(a) The National Laboratory Certification Program (NLCP) is the program established by HHS to certify laboratories before they are permitted to test specimens that are collected for Federal agency or federally regulated workplace drug testing programs. The NLCP includes a performance testing (PT) program and a laboratory inspection program.
(b) An applicant laboratory is required to pass 3 consecutive sets of initial PT samples and an initial inspection before becoming HHS certified.
(c) An HHS certified laboratory is required to test quarterly sets of maintenance PT samples, undergo an inspection 3 months after being certified, and undergo semiannual maintenance inspections thereafter.
(d) A laboratory must meet all the pertinent provisions of these Guidelines in order to qualify for and maintain certification. The Secretary has broad discretion to take appropriate action to ensure the full reliability and accuracy of drug testing and reporting, to resolve problems related to drug testing, and to enforce all standards set forth in these Guidelines. The Secretary has the authority to issue directives to any laboratory suspending the use of certain analytical procedures when necessary to protect the integrity of the testing process; ordering any laboratory to undertake corrective actions to respond to material deficiencies identified by an inspection or through proficiency testing; ordering any laboratory to send aliquots of specimens to another laboratory for retesting when necessary to ensure the accuracy of testing under these Guidelines; ordering the review of results for specimens tested under the Guidelines for private sector clients to the extent necessary to ensure the full reliability of drug testing for Federal agencies; and ordering any other action necessary to address deficiencies in drug testing, analysis, specimen collection, chain of custody, reporting of results, or any other aspect of the certification program.
9.2 How does a laboratory apply to the NLCP?
(a) A laboratory interested in becoming an HHS certified laboratory must submit an NLCP application form.
(b) The application form requires the applicant laboratory to provide detailed information on both the administrative and analytical procedures the laboratory proposes to use for testing regulated specimens after it is certified.
(c) The NLCP application form is available at the following website:
9.3 What is a PT sample?
(a) A PT sample is a sample that may contain:
(1) The drugs and/or metabolites in the drug classes that each laboratory must have the capability to test for;
(2) Both the parent drug and/or its major metabolite(s); or
(3) More than one drug class (but generally no more than two drug classes) to imitate real donor specimens.
(b) The concentration of the drugs and/or metabolites in a PT sample may be:
(1) At least 20 percent above the cutoff concentration for either the initial test or the confirmatory test (depending on which is to be evaluated);
(2) As low as 40 percent of the cutoff concentration when the PT sample is designated as a retest sample; or
(3) At another concentration for a special purpose.
(c) A negative PT sample may not contain a measurable amount of a target drug and/or metabolite.
(d) A PT sample may contain an interfering substance(s).
(e) For each PT cycle, the set of PT samples going to each laboratory will vary but, within each calendar year, each laboratory will have analyzed the same total set of samples.
(f) The laboratory must, to the greatest extent possible, handle, test, and report a PT sample in a manner identical to that used for a donor specimen, unless otherwise specified.
9.4 What are the performance testing requirements for an applicant laboratory?
An applicant laboratory must satisfy the following criteria on 3 consecutive sets of initial PT samples:
(a) No false positive results;
(b) Correctly identify and confirm 90 percent of the total drug challenges on the 3 sets of samples;
(c) The quantitative values for at least 80 percent of the total drug challenges must be within ?20 percent of the calculated reference group mean;
(d) No quantitative value on a drug concentration may differ by more than 50 percent from the calculated reference group mean; and
(e) For an individual drug, correctly detect and quantify at least 50 percent of the total drug challenges.
9.5 What are the performance testing requirements for a certified laboratory?
A certified laboratory must satisfy the following criteria on the maintenance PT samples to maintain its certification:
(a) Correctly identify and confirm 90 percent of the total drug challenges over two consecutive PT cycles;
(b) Correctly quantify 80 percent of the total drug challenges within ?20 percent of the appropriate reference or peer group mean as measured over two consecutive PT cycles;
(c) Have no more than one quantitative result differ more than 50 percent from the target value over two consecutive PT cycles; and
(d) For any individual drug, correctly detect and quantify at least 50 percent of the total drug challenges.
9.6 What are the inspection requirements for an applicant laboratory?
(a) An applicant laboratory is inspected by a team of at least two inspectors.
(b) Each inspector conducts an independent evaluation and review of all aspects of the laboratory?s procedures and facilities using the guidance provided by the Secretary and the National Laboratory Certification Program inspection checklist.
(c) To become certified, an applicant laboratory must satisfy the minimum requirements as stated in these Guidelines.
9.7 What are the inspection requirements for a certified laboratory?
(a) It must undergo an inspection 3 months after becoming certified and then inspected semiannually thereafter.
(b) A certified laboratory is inspected by a team of at least two inspectors. The number of inspectors required is dependent on the workload of the laboratory.
(c) Each inspector conducts an independent evaluation and review of all aspects of the laboratory?s procedures and facilities using the guidance provided by the Secretary and the National Laboratory Certification Program inspection checklist.
(d) To remain certified, a laboratory must continue to satisfy the minimum requirements as stated in these Guidelines.
9.8 Who may inspect a laboratory participating in the NLCP?
(a) The Secretary, a Federal agency using a certified laboratory, or the contractor awarded the HHS NLCP contract may inspect a laboratory at any time.
(b) An individual may serve as an NLCP inspector if he or she satisfies the following criteria:
(1) Has experience and an educational background similar to that required for either the responsible person or the certifying scientist as described in subpart K;
(2) Has read and thoroughly understands the policies and requirements contained in these Guidelines and in other NLCP documents;
(3) Submits a resume and documentation of qualifications to HHS;
(4) Attends NLCP approved training; and
(5) Submits an acceptable inspection report and has acceptable performance as a trainee on an inspection.
9.9 What happens if a laboratory does not satisfy the minimum requirements for either the PT program or the inspection program?
(a) If an applicant laboratory fails to satisfy the requirements established for the initial certification process, the applicant laboratory must start the initial certification process from the beginning.
(b) If a certified laboratory fails to satisfy the minimum requirements, the laboratory is given a period of time (e.g., 5 or 30 working days depending on the nature of the issue) to provide any explanation for its performance and evidence that any deficiency has been corrected.
(c) A laboratory’s certification may be revoked, suspended, or no further action taken depending on the seriousness of the errors and whether there is evidence that any deficiency has been corrected and that current performance meets the requirements for a certified laboratory.
(d) A certified laboratory may be required to undergo a special inspection or to test additional PT samples, depending on the nature of the performance, to verify that any deficiency has been corrected.
(e) If a laboratory’s certification is revoked or suspended, the laboratory is not permitted to test specimens for Federal agencies or federally regulated employers until the suspension is lifted or the laboratory has successfully completed the certification requirements as a new applicant laboratory.
9.10 Where is a list of certified laboratories published?
(a) A list of HHS certified laboratories is published monthly in the Federal Register.
(b) Applicant laboratories are not included in the list.
Subpart J – Blind Samples Submitted by an Agency
10.1 What are the requirements for a blind sample?
(a) A blind sample must be validated as to its content by the supplier using initial and confirmatory tests.
(b) The supplier must provide information regarding the shelf life of the blind sample.
(c) If the blind sample is positive, the concentration of the drug it contains must be at least 25 percent above the cutoff concentration for that drug.
10.2 What are the requirements for Federal agencies to submit blind samples?
(a) Each Federal agency is required to have both negative and positive blind samples submitted with its donor specimens.
(b) During the initial 90-day period of any new Federal agency drug testing program, the agency must ensure that at least 5 percent of the total number of donor specimens submitted are blind samples.
(c) After the initial 90-day period, the Federal agency must ensure that a minimum of 3 percent of the total number of donor specimens are blind samples.
(d) Approximately 80 percent of the blind samples may be negative (i.e., certified to contain no drug) and the remaining positive for one or more drugs.
(e) Each positive sample must be spiked only with those drugs for which the Federal agency is testing.
10.3 How is a blind sample submitted to the laboratory?
(a) A blind sample is either purchased by the Federal agency and given to the collector or the collector purchases the blind sample from a supplier and submits the blind sample with the Federal agency?s donor specimens.
(b) A blind sample is always submitted using the same CCF as used for a donor specimen. The collector provides the required information to ensure that the CCF has been properly completed as well as providing fictitious initials on the specimen bottle label/seal. Since there is no donor, the collector must indicate that the sample is a “blind sample” on the MRO copy where the donor would normally provide a signature.
(c) Each Federal agency must ensure that the required blind samples are distributed throughout the total number of donor specimens rather than submitted as a single group of samples.
10.4 What happens if an inconsistent result is reported on a blind sample?
The Medical Review Officer (MRO) is generally the individual who finds that a laboratory has reported an inconsistent result on a blind sample. When such a result is identified:
(a) The MRO must notify both the Federal agency and the Federal office responsible for maintaining the NLCP; and
(b) The Federal office responsible for the NLCP will initiate an investigation to determine the cause of the error and send a report to the MRO and the Federal agency describing the investigation and corrective action taken.
Subpart K – Laboratory Requirements
11.1 What is a Standard Operating Procedure Manual?
(a) An HHS certified laboratory must have a standard operating procedure (SOP) manual that describes, in detail, all laboratory operations. When followed, it ensures that all specimens are tested using the same procedures and in a consistent manner. The SOP manual must include, but is not limited to, a detailed description of the following:
(1) Chain-of-custody procedures;
(2) Accessioning;
(3) Security;
(4) Quality control/quality assurance programs;