DRAFT #4     9/5/2001

MANDATORY GUIDELINES FOR FEDERAL WORKPLACE DRUG TESTING PROGRAMS

(a) Executive Agencies as defined in 5 U.S.C. 105, excluding the testing of persons in the criminal justice system (e.g., arrestees, detainees, probationers, incarcerated persons, parolees);
(b) The Uniformed Services, as defined in 5 U.S.C. 2101(3) (but excluding the Armed Forces as defined in 5 U.S.C. 2101(2));
(c) Any other employing unit or authority of the Federal Government except the United States Postal Service, the Postal Rate Commission, and employing units or authorities in the Judicial and Legislative Branches; and
(d) The Intelligence Community, as defined by Executive Order No. 12333, only to the extent agreed to by the head of the affected Agency.

(a) Executive Order 12564 and Public Law 100-71 require the Department of Health and Human Services (HHS) to establish a Drug-Free Federal Workplace Program.
(b) Within HHS, the Division of Workplace Programs (DWP) in the Center for Substance Abuse Prevention, Substance Abuse and Mental Health Services Administration (SAMHSA), has been delegated the responsibility of providing:

(1) The day-to-day oversight of the Drug-Free Federal Workplace Program; and
(2) The development of comprehensive procedural and scientific standards for all aspects of a drug testing program.

(c) The Division of Workplace Programs provides written interpretations of the provisions in these Guidelines as written or electronic program documents, handbooks, manuals, and Federal Register notices.

(a) A Federal agency may not deviate from the provisions of these Guidelines without the written approval of the Secretary of Health and Human Services.
(b) In requesting approval for a deviation, a Federal agency must petition the Secretary in writing and describe the specific provision or provisions for which a deviation is sought and the rationale for the deviation.

(a) The Secretary of Health and Human Services is responsible for approving and publishing in the Federal Register major changes to these Guidelines. Examples of major changes include, but are not limited to, changes in cutoff concentrations, drugs tested, and scientific methods used.
(b) The Division of Workplace Programs is responsible for making minor changes as a result of improvements in the available science and technology. These minor changes are published as program documents or as Federal Register notices.

• Aliquot  A fractional part of a specimen used for testing. It is taken as a sample representing the whole specimen.
  
  
• Adulterated  A specimen containing either a substance that is not a normal constituent for that type of specimen or containing an endogenous substance at a concentration that is not a normal physiological concentration.
  
  
• Batch  A set of specimens being tested as a group.
  
  
• Blind Sample A sample with a known drug concentration or a certified drug free sample used to evaluate the ability of a laboratory to test a specimen for drugs and/or metabolites. The laboratory does not know either the concentration of the drug or that it is a blind sample
  
  
• Calibrato  A solution of known concentration in the appropriate matrix that is used to define expected outcomes of a measurement procedure or to compare the response obtained with the response of a test specimen aliquot/sample. The concentration of the analyte of interest in the calibrator is known within limits ascertained during its preparation. Calibrators may be used to establish a calibration curve over a range of interest.
  
  
• Canceled test  The MRO determines that the result reported by the laboratory cannot support reporting either a positive or a negative test to the employer.
  
  
• Certifying Scientist  (CS) The individual who is responsible for verifying the chain of custody and scientific reliability of a test result.
  
  
• Chain of Custody  (COC) Procedures to account for the integrity of each specimen or aliquot by tracking its handling and storage from point of specimen collection to final disposition of the specimen and its aliquots.
  
  
• Chain of Custody Document  The form(s) used to document the security of the specimen and all aliquots of the specimens during testing and storage. The form, which may account for an entire test batch, shall include the names and signatures of all individuals who handled the specimens or aliquots and the date and purpose of the access.
  
  
• Collection Site  A place where donors present themselves for the purpose of providing a specimen.
  
  
• Collector  A person who instructs and assists donors at a collection site and receives the specimen provided by the donor.
  
  
• Confirmatory Drug Test  A second analytical procedure performed on a different aliquot of the original specimen to identify and quantify the presence of a specific drug or drug metabolite.
  
  
• Confirmatory Validity Test   A second test performed on a different aliquot of the original specimen to further support a validity test result.
  
  
• Control  A sample used to evaluate whether an analytical procedure or test is operating within predefined tolerance limits.
  
  
• Cutoff  The concentration used to establish and report a specimen as negative or positive.
  
  
• Dilute  Refers to a specimen with less than normal physiological constituents.
  
  
• Donor   The individual from whom a specimen is collected.
  
  
• Failed to Reconfirm  The result reported when a laboratory is unable to corroborate the original result (i.e., positive, adulterated, substituted) reported to the Medical Review Officer.
  
  
• Federal Custody and Control Form  An OMB approved form used to document the collection, transport, security, and test results of the specimen.
  
  
• Follow-up Test  A specimen collected from a donor to ensure that the donor remains drug-free after being reinstated to a testing designated position.
  
  
• HHS  The Department of Health and Human Services or designee of the Secretary of Health and Human Services.
  
  
• HHS-Certified Instrumented Initial Test Facility (IITF)  A location where initial testing, reporting of results, and recordkeeping are performed under the supervision of a responsible technician.
  
  
• HHS-Certified Laboratory  A location where initial and confirmatory testing is performed under the supervision of an RP and where certifying scientists perform the final review and release of test results.
  
  
• Initial Drug Test  The test used to differentiate a negative specimen from one that requires further testing for drugs or drug metabolites.
  
  
• Initial Validity Test  The first test used to determine if a specimen is adulterated, diluted, or substituted.
  
  
• Invalid Result  The result reported when a scientifically supportable test result cannot be established for a specimen.
  
  
• Medical Review Officer (MRO)  A licensed physician who is certified to review, verify, and report test results to the employer.
  
  
• Negative Result  The result reported by an HHS-certified laboratory, IITF, or POCT tester to an MRO when a specimen contains no drug or the concentration of the drug is less than the cutoff concentration for that drug or drug class.
  
  
• Non-Negative ResultThe result reported by an HHS-certified laboratory when a specimen is either adulterated, substituted, or contains a drug or drug metabolite.
  
  
• Point of Collection Test Facility  A collection site where a point of collection test is conducted.
  
  
• Positive Result  The result reported by laboratory when a specimen contains a drug or drug metabolite greater than or equal to the cutoff concentration.
  
  
• Post Accident Test  A specimen collected from a donor after the donor is involved in a job-related accident.
  
  
• Pre-employment Test  A specimen collected from a donor who is applying for a testing designated position.
  
  
• Quality Control Sample  A calibrator, control, or blind sample.
  
  
• Random TestA specimen collected from a donor who is selected at random from a group of individuals who are included in a workplace drug testing program.
  
  
• Reasonable Suspicion/Cause Test  A specimen collected from a donor when there is sufficient evidence to indicate that the donor may have used an illicit substance.
  
  
• Reconfirmed  The result reported when a laboratory is able to corroborate the original result (i.e., positive, adulterated, substituted) reported to the Medical Review Officer.
  
  
• Rejected for Testing  The result reported by a laboratory or test facility when it does not perform any tests on the specimen because of a fatal flaw or an unrecovered correctable error.
  
  
• Responsible Person (RP)  The person who assumes professional, organizational, educational, and administrative responsibility for the day-to-day management of the HHS-certified laboratory.
  
  
• Responsible Technician (RT)  The person who assumes professional, organizational, educational, and administrative responsibility for the day-to-day management of the HHS-certified instrumented initial test facility.
  
  
• Return to Duty Test  A specimen collected from a donor to ensure that the donor is drug free prior to being reinstated in a testing designated position.
  
  
• Sample  A representative portion of a specimen or quality control material used for testing.
  
  
• Secretary  The Secretary of Health and Human Services or the Secretary's designee (e.g., Administrator, SAMHSA; Director, Division of Workplace Programs; a contractor; or other recognized organization that acts on behalf of the Secretary in implementing these Guidelines).
  
  
• Specimen  Fluid or material derived from the body which may be subdivided, concurrently collected, or two near simultaneously collected (if a split specimen is required).
  
  
• Split Specimen  A specimen collected at the collection site that is fluid or material derived from the body which has been subdivided or concurrently collected and independently sealed in the presence of the donor. For urine, one void that is subdivided. For hair, one "harvest" that is subdivided by strands. For oral fluid, one specimen collected that is subdivided or two near simultaneously collected specimens. For sweat, a patch that is subdivided or two separate patches that are applied and removed simultaneously.
  
  
• Standard  Reference material of known purity or a solution containing a reference material at a known concentration.
  
  
• Substituted  A specimen that could not have been derived from the donor's body at the time of collection.
  
  
  

(a) Hair: 100 mg hair
(b)Oral Fluid: 2 mL collected as a "neat specimen" (divided as follows: at least 1.5 mL for the primary specimen and at least 0.5 mL for the split specimen)
(c) Sweat: 1 FDA cleared "patch" worn for 7 to 14 days
(d) Urine: 45 mL (divided as follows: at least 30 mL for the primary specimen and at least 15 mL for the split specimen)

(a) Any specimen collected from a donor that is suspected to contain a Schedule I or II drug of the Controlled Substances Act (other than the drugs listed in section 3.1) may be tested for that drug on a case by case basis. The Federal agency must request the laboratory to test for that additional drug, ensure that the laboratory has the capability to test for the drug, and provide a justification to test for the drug.
(b) A Federal agency covered by these Guidelines must petition the Secretary in writing for approval to routinely test for any drug class not listed in section 3.1. Such approval shall be limited to the use of the appropriate science and technology and shall not otherwise limit agency discretion to test for any drug tested under paragraph (a) of this section.

(a) Determine the creatinine concentration on every specimen;
(b) Determine the specific gravity on every specimen for which the creatinine concentration is less than 20 mg/dL;
(c) Determine the pH on every specimen;
(d) Perform validity test(s) for substances that are commonly known as oxidizing adulterants; and
(e) Perform additional validity tests when the following conditions are observed:

(1) Abnormal physical characteristics (e.g., color, odor, excessive foaming);
(2) Reactions or responses characteristic of an adulterant obtained during initial or confirmatory drug tests (e.g., non-recovery of standards, unusual response); or
(3) Possible unidentified interfering substance or adulterant. The choice of additional validity tests is dependent on the observed indicators or characteristics as described in (e)(1) to (3).

(a) The nitrite concentration is confirmed to be greater than or equal to 500 mcg/mL;
(b) The pH is less than 3 or greater than or equal to 11;
(c) The specimen contains an exogenous substance (i.e., a substance which is not a normal constituent of urine); or
(d) The specimen contains an endogenous substance at a concentration greater than what is considered a normal physiological concentration.

(a) The creatinine concentration is less than 5 mg/dL; and
(b) The specific gravity is less than 1.002 or greater than or equal to 1.020.

(a) The creatinine concentration is less than 20 mg/dL;
(b) The specific gravity is less than 1.003; and
(c) The creatinine and specific gravity results do not meet the criteria for a substituted or invalid result.

(a) The laboratory detects an adulterant or interferent that it is unable to identify and the analysis has been performed on at least two separate aliquots of specimen;
(b) The laboratory performs only one colorimetric surfactant test on at least two separate aliquots of the specimen;
(c) The laboratory documents an interference with the GC/MS drug confirmation assay on at least two separate aliquots of the specimen;
(d) The laboratory documents incongruent creatinine and specific gravity results (e.g., a creatinine less than 5 mg/dL on both the initial and confirmatory tests and a specific gravity greater than or equal to 1.002 and less than 1.020 on either the initial or confirmatory tests, the laboratory documents a specific gravity of 1.000 on both the initial and confirmatory tests and a creatinine greater than or equal to 5 mg/dL on either the initial or confirmatory tests, or a creatinine greater than or equal to 5 mg/dL and less than 20 mg/dL on either the initial and confirmatory tests and a specific gravity greater than or equal to 1.020 on both the initial and confirmatory tests); or
(e) The laboratory documents a pH less than 4 or greater than or equal to 10 on at least two separate aliquots of specimen and does not meet the criteria for an adulterated specimen.

(a) A specimen may not be used for any other analysis or test unless otherwise authorized by the Guidelines or by the Secretary. (b) These Guidelines are not intended to prohibit any Federal agency specifically authorized by law to test for additional classes of drugs in its workplace drug testing program.

(a) An individual certified to collect specimens.
(b) The direct supervisor of a donor may not act as the collector when that donor is tested.

(a) Instruction on the collection procedure for each type of specimen;
(b) Training on chain of custody and recordkeeping; and
(c) A written examination covering the content of the training.

A collector must be certified by an HHS-approved collector certification program for each type of specimen being collected and must be re-certified every three years.

(a) An organization that wants to become an HHS-approved Collector Certification Program must apply to HHS to become an HHS-approved Collector Certification Program.
(b) The applying organization must:

(1) Establish a program that includes, at a minimum, the following:

(i) Training individuals on the collection of each type of specimen for which they will be certified;
(ii) Training on chain of custody, reporting, and recordkeeping;
(iii) A written examination covering the content of the training;
(iv) A mechanism to ensure that certified collectors are kept current regarding any changes in the collection procedures for each type of specimen; and
(v) A mechanism to track errors made by collectors that cause a test to be canceled in order to identify those that need to be retrained.

(2) Maintain a current list of individuals who have been certified as collectors. The list must be updated on a quarterly basis. The list must be provided to HHS electronically for posting on the HHS website.

a) A collector must be retrained when:

(1) The collection procedure changes significantly (e.g., a new CCF is used); or
(2) The collector makes a mistake that causes a test to be canceled.

(b) The required retraining:

(1) Must be focused in the specific area of collection procedures that changed or on the mistake that caused the test to be canceled; and
(2) Must be documented in writing by HHS-approved Collector Certification Program.

(a) Ensure that the collector has a current collector certification document issued by an HHS-approved collector certification program;
(b) Retain a copy of collector's certification document as long as the person performs collector functions and for 2 years after the collector leaves the organization; and
(c) Provide to the collector the name and telephone number of the agency's representative to contact about problems or issues that may arise during a specimen collection procedure.

(a) A collection site may be a permanent or temporary facility located either at the work site or at a remote site.
(b) The selection of an appropriate collection site will depend on the type of specimen being collected.

(a) A suitable clean surface for handling the specimen and completing the required paperwork;
(b) A secure temporary storage capability to maintain a specimen until it is tested or shipped to the laboratory;
(c) A facility to provide donor privacy appropriate to the specimen being collected;
(d) A facility to restrict access to only authorized personnel during the collection;
(e) Ability to restrict access to collection supplies; and
(f) Ability to store records securely.

(a) Do not allow unauthorized personnel to enter the collection site during the collection;
(b) Perform only one specimen collection at a time;
(c) Restrict access to collection supplies before and during the collection;
(d) Ensure that you are the only person other than the donor to handle the unsealed specimen; and
(e) Immediately seal the specimen container in the presence of the donor.

(a) For urine, the collector must give the donor visual privacy while providing the specimen unless:

(1) A previous drug test was reported either positive for a drug, adulterated, substituted, unsuitable for testing, or canceled because the split specimen was not tested;
(2) The drug test is a return-to-duty or a follow-up test;
(3) The agency/employer believes that the donor may alter or substitute the specimen to be provided; or
(4) During a routine collection, the temperature of the specimen collected is outside the acceptable range, the collector observed materials brought to the collection site or donor conduct indicated a possible attempt to adulterate or substitute a specimen, or the collector believes that the specimen has been adulterated (e.g., the specimen is blue, exhibits excessive foaming when shaken, has smell of bleach).

(b) For hair, the collector collects head hair from the donor unless it is not available. The donor must be allowed privacy while the collector obtains the hair sample. The policy for collecting hair from other areas of the body is described in the HHS Specimen Collection Handbook.
(c) For sweat, the sweat patch is applied to the donor's upper arm, chest, or back by the collector. The donor must be allowed privacy during the application and removal of the patch by the collector.
(d) For oral fluid, the "neat" oral fluid is provided directly into an appropriate container by the donor under the direct observation of the collector. Only the collector may be present while the donor provides the "neat" oral fluid specimen.

(a) A complete list of the supplies needed 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: workplace.samhsa.gov

(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 Federal CCF used for each type of specimen collected is available from a number of different sources. A sample of the OMB-approved Federal CCF for each type of specimen is available at the following website: workplace.samhsa.gov
(d) Federal agencies and employers regulated by the Department ofTransportation (DOT) are required to use the OMB-approved Federal CCF for their workplace drug testing programs.

(a) When the collector either by mistake or as the only means to document a collection 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.

(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.
(2) For hair, it is the foil or other specimen guide and single-use plastic bag or other container in which the specimen is placed.
(3) For oral fluid, it is the single-use plastic specimen container.
(4) For sweat, it is the patch placed on the skin.

(b) A collection device must not affect or alter the specimen collected.
(c) The supplier of a collection device must evaluate the device to ensure that it does not affect the specimen collected.

(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 (e.g, the sweat patch).
(b) Single-use items (such as, plastic bottles, containers, plastic bags, foil) are not unique collection devices and, therefore, are not required to be cleared by the FDA.

(a) Verify the donor's identification;
(b) Provide 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 reasonable and appropriate question the donor may have regarding the collection procedure.

(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, if such handling is part of the collection procedure. 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 (refer to 12.12 if conducting a POCT).
(d) After a specimen is collected, the collector inspects the specimen for signs of tampering.
(e) A tampered specimen is sent to the laboratory for testing and the collector documents the tampering on the Federal CCF.
(f) When a tampered specimen is collected, the collector immediately collects another specimen. This second specimen must also be sent to the laboratory.
(g) Once collected, the collector and donor must keep the specimen in view at all times prior to sealing the specimen container.
(h) A tamper-evident label/seal must be used to secure the specimen container.
(i) The donor must initial the label and the collector must date the label after it is used to secure the specimen container.
(j) The collector must complete the CCF and distribute each copy as required.

(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: workplace.samhsa.gov

(a)The HHS National Laboratory Certification Program (NLCP) is the program established 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 maintenance inspections every 6 months 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 performance testing; ordering any laboratory to send specimens or specimen aliquots 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.
(e) A laboratory is prohibited from stating or implying certification for matrix (ces) unless it holds such certification for each type of specimen it wants to test for federally regulated programs.

(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: workplace.samhsa.gov

(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; or
(2) 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 are:

(1) At least 50 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, an adulterant, or a specimen that meets the criteria for a substituted specimen.
(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.

(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.

(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.

(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.
(d) The applicant laboratory must be separately inspected for each specimen matrix for which it has applied. The inspection may be conducted concurrently, but the inspectors must review all appropriate data in distinct audits.

(a) A certified laboratory must undergo an inspection 3 months after becoming certified and then inspected every 6 months 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 for that specimen matrix.

(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 performs acceptably as a trainee inspector on an inspection.

(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.

(a) A list of HHS-certified laboratories and the specimen matrix they are certified to perform, is published monthly in the Federal Register and is also available on the following website: workplace.samhsa.gov
(b) An applicant laboratory is not included on the list.

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 between 1.5 and 2 times the initial drug test cutoff concentration.
(d) If the blind sample is adulterated or substituted, its characteristics must clearly show that it is an adulterated or substituted sample when validated by the supplier.

(a) Each Federal agency is required to have both negative and non-negative 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 3 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 1 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 non-negative.
(e) Each drug positive sample must be spiked only with those drugs for which the Federal agency is testing its specimens.

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 OMB-approved Federal 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 label/seal. 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.

(a) The MRO must contact the blind sample supplier and determine if the supplier may have made a mistake when preparing the blind sample;
(b) The MRO must contact the collector and determine if the collector made an error when preparing the blind sample for shipment to the laboratory;
(c) If there is no obvious reason for the inconsistent result, the MRO must notify both the Federal agency for which the blind sample was submitted and the Federal office responsible for maintaining the NLCP; and
(d) The Federal office responsible for the NLCP will investigate the blind sample error and send a report to the MRO and the Federal agency describing the investigation and corrective action taken.

(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.
(b) 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;
(5) Analytical methods and procedures;
(6) Equipment and maintenance programs;
(7) Personnel training;
(8) Reporting procedures; and
(9) Computers, software, laboratory information management systems

(c) All procedures in the SOP manual must be in compliance with these Guidelines and NLCP Program Documents.
(d) 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.

(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 in the drug testing laboratory, and followed by those personnel. The SOP manual must be reviewed, signed, and dated by the RP(s) 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; verify and 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, and deficiencies identified during inspections. 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 positive, adulterated, and substituted test results.

(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.

(a) The individual (i.e., the certifying scientist) who certifies a positive, adulterated, or substituted test result must have:

(1) A bachelor's degree in the chemical or biological sciences, medical technology, or similar field;
(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) The individual (i.e., the certifying technician) who certifies a negative test result must have:

(1) Training and experience in the analytical methods and procedures used by the laboratory that are relevant to the results that the individual certifies; and
(2) 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.

(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 with regulated specimens.

(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) 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.
(c) A laboratory must maintain a record that documents the dates, time of entry and exit, and purpose of entry of authorized escorted visitors accessing secured areas.

(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.

(a) A test used to differentiate a negative specimen from a specimen that requires further testing for drugs.
(b) An immunoassay test or test that combines a chromatographic separation coupled with an appropriate detector.
(c) An initial test must be validated before it is used to test donor specimens.
(d) Commercially distributed initial tests must have FDA clearance.
(e) 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.

(a) The laboratory must demonstrate and document:

(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) Performance of new lots must be verified prior to being placed into service.

(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; and
(3) At least one control that has the concentration of the drug or metabolite at 25 percent below the cutoff concentration.

(b) At least 10 percent of the batch must be calibrators and controls.
(c) A laboratory must document that any carryover that might occur between aliquots during the initial testing is detectable and corrected.

(a) A confirmatory drug 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.

(a) The linear range of the analysis;
(b) The limit of detection;
(c) The limit of quantitation;
(d) The accuracy and precision at the cutoff concentration;
(e) The accuracy and precision at 40 percent of the cutoff concentration; and
(f) The potential for interfering substances.

(a) Each batch of specimens must contain, at a minimum, 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 within 25 percent above the cutoff concentration; and
(4) At least one control in every batch must be blind.

(b) At least 10 percent of each batch must be calibrators and controls.
(c) On a retest/reconfirmation challenge, the batch must have one control that has the concentration of the drug or metabolite at or below 40 percent of the cutoff concentration.
(d) The linear range, limit of detection, and limit of quantitation must be documented and periodically re-evaluated for each confirmatory drug test.
(e) A laboratory must document that any carryover that might occur between aliquots/extracts in the confirmatory batch is detectable and corrected.

(a) A validity test result for a specimen shall be based on performing an initial (first) validity test on one aliquot and a confirmatory (second) validity test on a second aliquot. In some cases, both validity tests may use the same procedure, instrument, and/or method.
(b) The performance characteristics (e.g., accuracy, precision, LOD, LOQ, linearity, specificity) shall be documented for each validity test as appropriate.
(c) The LOD shall be determined for those adulterants that do not have a cutoff otherwise specified in these Guidelines (e.g., glutaraldehyde, halogens, chromates).
(d) Each analytical run of specimens for which an initial or confirmatory validity test is being performed shall include the appropriate calibrators and controls.

(a) Specific requirements for measuring creatinine concentration are:

(1) The creatinine concentration shall be measured to one decimal place on both the initial test and the confirmatory test.
(2) The initial creatinine test shall have a calibrator at either 5 mg/dL or at 20 mg/dL.
(3) The initial creatinine test shall have a control in the range of 2 mg/dL to 4 mg/dL, a control in the range of 5 mg/dL to 20 mg/dL, and a control in the range of 21 mg/dL to 25 mg/dL.
(4) The confirmatory creatinine test (performed on those specimens with a creatinine concentration less than 5 mg/dL on the initial test) shall have a calibrator at 5 mg/dL or at 20 mg/dL, a control in the range of 2 mg/dL to 4 mg/dL, and a control in the range of 6 mg/dL to 8 mg/dL.

(b) Specific requirements for measuring specific gravity are:

(1) The specific gravity shall be measured using a refractometer on both the initial and confirmatory specific gravity tests in order to report a specimen as substituted. Dilute specimens may, however, be reported based on refractometer results from the initial test. The refractometer shall be capable of reading in increments of at least 0.001 or less.
(2) The initial and confirmatory specific gravity tests shall have a calibrator at 1.000.
(3) The initial and confirmatory specific gravity tests shall have the following controls:

(i) For the cutoff of less than 1.002, one control at 1.001 and one control in the range of 1.002 to 1.010.
(ii) For the cutoff of greater than or equal to 1.020, one control greater than or equal to 1.020 but not greater than 1.025, and one control in the range of 1.015 to 1.020.

(c) Specific requirements for measuring pH are:

(1) Dipsticks, pH paper, and spectrophotometric/colorimetric tests that have a narrow dynamic range and lack the accuracy necessary to support the specified program cutoffs may be used only to determine if the initial and confirmatory pH validity tests must be performed.
(2) Spectrophotometric/colorimetric tests which have the dynamic range and accuracy necessary to support the specified program cutoffs and which are capable of measuring pH to one decimal place may be used as an initial test.
(3) A pH meter capable of measuring the pH to at least one decimal place may be used to perform the initial test and shall be used to perform the confirmatory test.
(4) The initial and confirmatory pH meter tests shall have the following controls:

(i) For the cutoff of less than 3, one control in the range of 2 to 2.9 and one control in the range of 3.1 to 4.
(ii) For the cutoff of greater than or equal to 11, one control in the range of 10 to 10.9 and one control in the range of 11.1 to 12.

(5) Spectrophotometric/colorimetric initial pH tests shall have the following controls:

(i) For the cutoff of less than 3, one control in the range of 2 to 2.9.
(ii) For the cutoff of greater than or equal to 11, one control in the range of 11.1 to 12.

(d) Specific requirements for performing oxidizing adulterant tests are:

(1) At a minimum, the initial test(s) for oxidizing adulterants shall be capable of detecting nitrites, chromates, and halogens (e.g., bleach, iodine). The detection of these adulterants may be achieved by using either a general oxidizing adulterant test or by using specific tests for each category of these adulterants. If an initial test for oxidizing adulterants simultaneously tests for all oxidizing adulterants, the assay shall be able to detect at least the activity equivalent to 20 mcg/mL of chromate (chromium VI) or 200 mcg/mL of nitrite as an LOD. Each analytical run of specimens shall include a control without the compound of interest (i.e., a certified negative control) and at least one positive control with one of the compounds of interest at a concentration which exhibits an oxidizing activity above the documented LOD of the procedure.
(2) A confirmatory test for a specific oxidizing adulterant shall use a different analytical principle or chemical reaction than that used for the initial test unless a recognized reference method is used for both the initial and confirmatory tests. Each analytical run of specimens shall include a control without the compound of interest (i.e., a certified negative control) and a positive control with the compound of interest at a concentration above the documented LOD of the procedure.

(e) Specific requirements for measuring the nitrite concentration are:

(1) Dipsticks may only be used to determine if initial and confirmatory nitrite tests shall be performed.
(2) A nitrite specific initial test shall have a calibrator at the cutoff concentration, a negative control (i.e., certified negative urine), one control in the range of 200 mcg/mL to 500 mcg/mL, and one control in the range of 500 mcg/mL to 625 mcg/mL
(3) The confirmatory nitrite test shall have a calibrator at the cutoff concentration, a negative control (i.e., certified negative urine), one control in the range of 200 mcg/mL to 500 mcg/mL, and one control in the range of 500 mcg/mL to 625 mcg/mL.

(f) Specific requirements for performing other validity tests (e.g., glutaraldehyde, surfactants) are:

(1) Each analytical run of specimens shall include a control without the compound of interest (i.e., a certified negative control) and a positive control with the compound of interest at a concentration above the documented LOD of the procedure.
(2) A confirmatory test for a specific adulterant shall use a different analytical principle or chemical reaction than that used for the initial test unless a recognized reference method is used for both the initial and confirmatory tests.
(3) The initial and confirmatory tests for anionic surfactants shall be able to detect at least the activity equivalent to 100 mcg/mL of dodecylbenzene sulfonate.

(a) A laboratory must report a test result within 5 (on average) working days after receipt of the specimen.
(b) A positive drug test result must be based on an initial drug test and a confirmatory drug test.
(c) An adulterated or substituted test result must be based on an initial validity test and a confirmatory validity test.
(d) A laboratory must report the concentration of the drug or metabolite for a positive result.
(e) A laboratory must report the specific validity test result(s) for a specimen that is reported adulterated or substituted.
(f) A test result must be reported directly to an MRO.
(g) A laboratory may report all test results using the HHS standard electronic laboratory report. The electronic report must be transmitted to the MRO in a manner that ensures the confidentiality and security of the information.
(h) A laboratory must fax, mail, or transmit a scanned image of a completed Copy 1 of the CCF to the MRO when the result is reported as either positive for a specific drug, adulterated, substituted, rejected for testing, or invalid result.
(i) The HHS standard electronic laboratory report is sufficient to report a negative result to the MRO.
(j) A test result may not be provided telephonically; however, the MRO may call the laboratory to discuss a result.
(k) A laboratory must use its own form to report the result when retesting a single specimen.

(a) A laboratory must retain a specimen that was reported either positive, adulterated, substituted, 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.

(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.

(a) An HHS-certified laboratory may store and archive all records electronically.
(b) The laboratory must validate that the method used to create the electronic records provides an accurate representation of the original records.
(c) The method used to create the electronic records must prevent the alteration of any stored information and/or data.
(d) The method used must allow easy retrieval and re-creation of the original records.

(a) A laboratory must send on a semiannual basis to the Division of Workplace Programs the number of Federal agency and the number of DOT regulated specimens:

(1) Reported
(2) The number grouped by reason for test as follows:

(i) Random
(ii) All others reasons combined

(3) The number that were:

(i) Positive for each drug (listed separately)
(ii) Adulterated
(iii) Substituted
(iv) Rejected for Testing
(v) Invalid Result

(b) The report must be submitted to the Division of Workplace Programs by mail, fax, or email within 10 working days after the end of the quarter.

(a) A Federal employee who is the subject of a drug test may, upon written request through the MRO and the Federal agency, have access to a documentation package.
(b) The documentation package is limited to copies of the analytical data for the donor's specimen and associated quality control samples, chain of custody records, and other administrative documents generated during the handling and testing of the donor's specimen that support the test result reported by the laboratory.

(a) Non-instrumented for which the endpoint result is obtained by visual evaluation (i.e., read by human eye); or
(b) Instrumented for which the result is obtained by instrumental evaluation (e.g., densitometer, spectrophotometer, fluorometer).

(a) The POCT device must be cleared by the FDA.
(b) The POCT device must be included on the HHS Conforming Products List.

(a) Oral fluid (saliva)
(b) Urine

(a) The collection site (mobile or permanent) must satisfy all the requirements for a collection site; and
(b) Appropriate supplies and manuals must be available.

(a) The manufacturer/organization managing the POCT tester certification program must apply to HHS to become an HHS-approved POCT tester certification program.
(b) The applying manufacturer/organization must:

(1) Establish a program that includes, at a minimum, the following:

(i) Instruction on the use of the POCT that the tester will be using;
(ii) Instruction on the interpretation of POCT results;
(iii) Training on chain of custody procedures, reporting, and recordkeeping;
(iv) A written examination covering the content of the training;
(v) A mechanism to ensure that certified POCT testers are kept current regarding any changes in the POCT test for each type of specimen; and
(vi) A mechanism to identify testers that would need to be retrained because of errors associated with incorrect use of the POCT.

(2) Maintain a current list of individuals who have been trained to use the POCT. The list must be updated on a quarterly basis. The list must be provided to HHS electronically for posting on the HHS website.

(a) A donor must not have access to the testing device.
(b) A POCT must be conducted on an aliquot of the specimen before the specimen is sealed for shipment to a testing laboratory or after the entire specimen is transferred to an integrated specimen collection container/POCT device.
(c) Chain of custody must be maintained and documented for the specimen and any aliquot used for the POCT.
(d) A specimen that tests negative must be discarded unless it is submitted as part of the quality assurance program.
(e) A non-negative specimen is resealed using a tamper-evident label/seal, sent with the split specimen to an HHS-certified laboratory for testing, and the POCT result is indicated on the transmittal chain of custody document.
(f) The POCT tester must complete a POCT before beginning another POCT.

(a) For drug POCTs:

(1) Each day testing is performed, at least one negative control (i.e., certified to contain no drug or drug metabolite) and one positive control (i.e., the concentration of the drugs or metabolites in the range of 25 percent above the cutoff concentration) must be tested; or
(2) The positive control described above must be tested immediately after each presumptive positive donor specimen.

(b) For validity POCTs:

(1) Each day testing is performed, at least one control that is normal for the specific validity test and one control that is abnormal must be tested; or
(2) An abnormal control must be tested immediately after each adulterated or substituted donor specimen.

(c) At least 1 specimen out of every twenty specimens that are tested negative must be submitted to an HHS-certified laboratory as part of a Quality Assurance Program.

(a) For option (a)(1) in section 12.13, the failed quality control sample must be sent to an HHS-certified laboratory. The POCT tester must continue testing QC samples until acceptable results are obtained before testing donor specimens. If acceptable QC results cannot be obtained, donor specimens must be sent directly to the HHS-certified laboratory.
(b) For option (a)(2) in section 12.13, the POCT tester must send both the failed QC sample and the presumptive positive, adulterated, or substituted donor specimen to the HHS-certified laboratory. The POCT tester must immediately test a negative QC sample before any donor specimens are tested.

(a) A PT sample is a sample that may contain:

(1) The drugs and/or metabolites in the drug classes that each POCT must have the capability to test for; or
(2) 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 are:

(1) At least 50 percent above the cutoff concentration for the initial test; or
(2) 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, an adulterant, or a specimen that meets the criteria for a substituted specimen.
(e) For each PT cycle, the set of PT samples going to each POCT manufacturer will vary but, within each calendar year, each POCT manufacturer will have analyzed the same total set of samples.

(a) The Secretary, a Federal agency using a POCT, or the contractor awarded the HHS inspection contract may inspect a POCT manufacturer at any time.
(b) An individual may serve as an inspector of a POCT manufacturer 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; and
(4) Attends NLCP approved training.

(a) Each POCT manufacturer is inspected annually by at least one inspector under an HHS contract.
(b) The inspector conducts an evaluation and review of all aspects of the POCT manufacturer's procedures and facilities using HHS guidance.

(a) HHS will give the POCT manufacturer thirty days to complete appropriate corrective action.
(b) If corrective action has not been completed within 30 days, the POCT will be removed from the HHS Conforming Products List until the manufacturer can return the POCT to compliance.

(a) Each presumptive positive, adulterated, or substituted specimen is sent to an HHS-certified laboratory for additional testing.
(b) A POCT tester must send 1 of every 20 negative specimens to an HHS-certified laboratory to be tested. Other negative specimens are discarded.

(a) All POCT records may be stored electronically.
(b) The POCT tester must validate that the method used to create the electronic records provides an accurate representation of the original records.
(c) The method used to create the electronic records must prevent the alteration of any stored information and/or data.
(d) The method used must allow easy retrieval and re-creation of the original records.

(a) A POCT tester must send on a semiannual basis to the Division of Workplace Programs the number of Federal agency and the number of DOT regulated specimens:

(1) Tested
(2) The number grouped by reason for test as follows:

(i) Random
(ii) All others reasons combined

(3) The number that were:

(i) Screened positive for each drug (listed separately)
(ii) Screened as adulterated
(iii) Screened as substituted
(iv) Invalid Result (i.e., unsuitable for testing)

(4) The total number of quality control samples tested

(i) The number of acceptable QC sample results
(ii) The number of failed QC sample results

(b) The report must be submitted to the Division of Workplace Programs by mail, fax, or email within 10 working days after the end of the semiannual period.

(a) An employee tested under a federally regulated workplace drug testing program may, upon written request through the Agency and the MRO, have access to a documentation package.
(b) The documentation package is limited to copies of the analytical data for the donor's specimen and associated quality control samples, chain of custody records, and other administrative documents generated during the handling and testing of the donor's specimen that support the test result reported by the POCT tester.

(a) A negative result is reported directly to an MRO within 3 (on average) working days after the test is conducted.
(b) A POCT tester may report a negative test result using the HHS standard electronic laboratory report for a negative result. The electronic report must be transmitted to the MRO in a manner that ensures the confidentiality and security of the information.
(c) A POCT tester may not report test results telephonically.

(a) A facility at a permanent location that conducts only instrumented initial drug and validity tests (as described for an HHS-certified laboratory in subpart K);
(b) Has satisfied the certification requirements for each type of specimen the IITF wants to test;
(c) Passed 3 consecutive sets of PT samples for each type of specimen to be tested and an initial inspection before becoming HHS-certified;
(d) Participates in a quarterly maintenance PT sample program and is inspected every 6 months; and
(e) Managed by a full-time responsible technician (RT).

(a) Hair
(b) Oral fluid (saliva)
(c) Sweat (patch) (d) Urine

(a) An HHS-certified IITF must have a standard operating procedure (SOP) manual that describes, in detail, all IITF operations. When followed, it ensures that all specimens are tested using the same procedures and in a consistent manner.
(b) 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;
(5) Analytical methods and procedures;
(6) Equipment and maintenance programs;
(7) Personnel training;
(8) Reporting procedures; and
(9) Computers, software, laboratory information management systems

(c) All procedures in the SOP manual must be in compliance with these Guidelines and NLCP Program Documents.
(d) 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 IITF to retrieve the procedures that were used to test a specimen.

(a) A bachelor's degree in the chemical or biological sciences, medical technology, or similar field;
(b) Training and experience in the analytical methods and procedures used by the IITF that are relevant to the results; and
(c) Training and experience in reviewing and reporting test results, maintenance of chain of custody, recordkeeping, and understanding proper remedial action in response to problems that may arise.

(a) Manage the day-to-day operations of the IITF.
(b) Ensure that there are enough personnel with adequate training and experience to conduct and operate the work of the IITF. The RT must ensure the continued competency of testing facility 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 at the IITF, and followed by those personnel. The SOP manual must be reviewed, signed, and dated by the RT whenever procedures are first placed into use or changed or when a new individual assumes responsibility for management of the IITF.
(d) Verify and 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 device/system used at that testing facility.
(e) Implement all remedial actions necessary to maintain satisfactory operation and performance of the testing facility 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 an operator of the initial test analyzers used at the IITF.

(a) Training and experience in the analytical methods and procedures used by the IITF that are relevant to the results that the individual certifies; and
(b) 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.

(a) All IITF staff (e.g., technicians, administrative staff) must have the appropriate training and skills for the tasks assigned.
(b) Each individual working in a certified IITF must be properly trained before he or she is permitted to work independently in any area of the facility with regulated specimens.
(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.

(a) An IITF must control access to the facility and ensure that no unauthorized individual can gain access to specimens, aliquots, or records.
(b) With the exception of personnel authorized to conduct inspections on behalf of Federal, state, or other accrediting agencies for which the IITF 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.
(c) An IITF must maintain a record that documents the dates, time of entry and exit, and purpose of entry of authorized visitors and authorized escorts to accessing secured areas.

(a) An IITF 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 using either hard copy or electronic procedures.
(c) Chain of custody documentation must be completed at the time of the transaction.

(a) Submit an application to the designated HHS contractor.
(b) Furnish detailed information on both the administrative and analytical procedures the IITF proposes to use for testing regulated specimens after it is certified.
(c) The application form is available at the following website: workplace.samhsa.gov

(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 are:

(1) At least 50 percent above the cutoff concentration for the initial test; or
(2) 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, an adulterant, or a specimen that meets the criteria for a substituted specimen.
(e) For each PT cycle, the set of PT samples going to each initial test facility will vary but, within each calendar year, each IITF will have analyzed essentially the same total set of samples.
(f) The IITF must, to the greatest extent possible, handle and test a PT sample in a manner identical to that used for a donor specimen, unless otherwise specified.

(a) An applicant IITF is inspected by at least one inspector.
(b) The inspector conducts an evaluation and review of all aspects of the IITF.
(c) An IITF becomes certified after satisfying the minimum requirements as stated in these Guidelines.
(d) Maintenance inspections of certified IITFs will be conducted by at least one inspector every 6 months.

(a) The Secretary, a Federal agency using a certified IITF, or the contractor awarded the HHS NLCP contract may inspect an IITF at any time.
(b) An individual may serve as an inspector if he or she satisfies the following criteria:

(1) Has experience and an educational background similar to that required for the Responsible Technician;
(2) Has read and thoroughly understands the policies and requirements contained in these Guidelines and in other program documents;
(3) Submits a resume and documentation of qualifications to HHS;
(4) Attends an HHS-approved inspector training program; and
(5) Submits an acceptable inspection report and has acceptable performance as a trainee on an inspection.

(a) If an applicant IITF fails to satisfy the requirements established for the initial certification process, the applicant IITF must start the initial certification process from the beginning.
(b) If a certified IITF fails to satisfy the minimum requirements, the IITF is given a period of time (e.g., 5 or 30 working days depending on the nature of the issue) to furnish any explanation for its performance and evidence that any deficiency has been corrected.
(c) An IITF'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 instrumented initial test facility.
(d) A certified IITF 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 an IITF's certification is revoked or suspended, the IITF is not permitted to test specimens for Federal agencies or federally regulated employers until the suspension is lifted or the instrumented initial test facility has successfully completed the certification requirements as a new applicant.

(a) A specimen that is negative on initial drug tests and/or initial validity tests is discarded after batch requirements are met as specified in section 13.12.
(b) A non-negative specimen is immediately forwarded to an HHS-certified laboratory for confirmatory testing.

(a) An IITF must retain all records generated to support test results for at least 2 years.
(b) A Federal agency may request the IITF to maintain records associated with a particular specimen under legal challenge for an indefinite period.

(a) An HHS-certified IITF may store and archive all records electronically.
(b) The IITF must validate that the method used to create the electronic records provides an accurate representation of the original records.
(c) The method used to create the electronic records must prevent the alteration of any stored information and/or data.
(d) The method used must allow easy retrieval and re-creation of the original records.

(a) An IITF must send on a semiannual basis to the Division of Workplace Programs the number of Federal agency and the number of DOT regulated specimens:

(1) Tested
(2) The number grouped by reason for test as follows:

(i) Random
(ii) All others reasons combined

(3) The number that were:

(i) Screened positive for each drug (listed separately)
(ii) Screened as adulterated
(iii) Screened as substituted
(iv) Rejected for Testing
(v) Invalid Result

(b) The report must be submitted to the Division of Workplace Programs by mail, fax, or email within 10 working days after the end of the quarter.

(a) A certified negative test result is reported directly to an MRO within 3 (on average) working days after receipt of the specimen.
(b) An IITF may report negative test results using the HHS standard electronic laboratory report. The electronic report must be transmitted to the MRO in a manner that ensures the confidentiality and security of the information.
(c) An IITF may not report test results telephonically; however, an MRO may call the IITF to discuss a result.

(a) The specimen that was tested is resealed using a tamper-evident label/seal;
(b) The individual resealing the specimen initials and dates the tamper-evident label/seal;
(c) The resealed specimen and split specimen are sent to an HHS-certified laboratory for confirmatory testing; and
(d) The IITF provides the test result on the transmittal chain of custody document.

(a) A list of current HHS-certified IITFs is published monthly in the Federal Register and is also available on the following website: workplace.samhsa.gov
(b) An applicant IITF is not included on the list.

(a) A licensed physician holding either a Doctor of Medicine (M.D.) or Doctor of Osteopathy (D.O.) degree.
(b) The physician must be certified by an HHS-approved MRO certification board.
(c) The MRO may be either an employee of the Federal agency or a contractor for the Federal agency.

(a) Instruction on the collection procedures for each type of specimen;
(b) Training on chain of custody, reporting, and recordkeeping;
(c) Interpretation of test results; and
(d) Federal workplace regulations policies.

(a) An organization that wants to become an HHS-approved MRO certification board must apply to HHS to become an HHS-approved MRO Certification Board.
(b) The applying organization must:

(1) Establish a program that includes, at a minimum, the following:

(i) A thorough review of the collection procedures for each type of specimen;
(ii) A thorough review of the procedures for conducting POCT tests;
(iii) A thorough review on interpreting test results;
(iv) Training on chain of custody, reporting, and recordkeeping;
(v) A written examination covering the content of the training; and
(vi) A mechanism to ensure that certified MROs are kept current regarding any changes in the guidelines/regulations for each type of specimen.

(2) Maintain a current list of individuals who have been certified as MROs. The list must be updated on a quarterly basis. The list must be provided to HHS electronically for posting on the HHS website.

(a) The MRO must:

(1) Review the information on the MRO copy of the Federal CCF that was received from the collector and the report received from the laboratory, IITF, or POCT site;
(2) Interview the donor when required;
(3) Make a determination regarding the test result;
(4) Report the verified result to the Federal agency; and
(5) Maintain the records (for a minimum of 2 years) and the confidentiality of the information.

(b) The review of a non-negative test result shall be performed by the MRO before the result is transmitted to the agency's designated representative. Staff under the direct, personal supervision of the MRO may review and report a negative test result to the agency's designated representative. The MRO shall cancel the result for any agency's urine specimen that is not collected or tested in accordance with these Guidelines.
(c) Before an MRO verifies a specimen positive for opiates, the MRO must determine that there is clinical evidence of illegal use by the donor of an opium, opiate, or opium derivative (e.g., morphine/codeine) listed in Schedule I or II of the Controlled Substances Act. This requirement does not apply if the confirmatory procedure for opiates confirms the presence of 6-acetylmorphine since the presence of this metabolite is proof of heroin use.
(d) The MRO review process is described in detail in the HHS/DOT MRO Manual. It is available at the following website: workplace.samhsa.gov

(a) Prior to making a final decision on a specimen that was reported positive, adulterated, substituted, or an invalid test result by the laboratory, the MRO shall give the donor an opportunity to explain the test result. In carrying out this responsibility, an MRO shall evaluate alternative medical explanations for the positive, adulterated, substituted, or invalid test result. This action should include conducting an interview with the donor, review of the donor's medical history, or review of any other biomedical factors. The MRO shall review medical records made available by the donor when a result could have resulted from taking legally prescribed medication. Following verification of the laboratory test result, the MRO reports the verified result to the agency's designated representative.
(b) When a laboratory reports an invalid result due to the possible presence of an unidentified interfering substance/adulterant, the MRO:

(1) May direct the laboratory to send the specimen to another HHS certified laboratory to possibly identify the interfering substance/adulterant;
(2) Shall report the result as "Test Cancelled" and an immediate direct observed collection is not required if the explanation provided by the donor is acceptable; or
(3) Shall report the result as "Test Cancelled" and indicates that an immediate direct observed collection is required if the explanation provided by the donor is not acceptable.

(a) For a positive, adulterated, or substituted result reported on a primary specimen, a donor may request through the MRO that the split specimen be tested by a second HHS-certified laboratory to verify the result reported by the first laboratory.
(b) The donor has 72 hours (from the time the MRO notified the donor that his or her specimen was reported positive, adulterated, or substituted) to request a test of the split specimen.

(a) Ensure that the physician has a current MRO certificate issued by an HHS-approved MRO certification board; and
(b) Retain a copy of the certificate as long as the physician performs MRO functions and for 2 years after the MRO ceases to perform services for the Federal agency.

(a) An MRO must not be an employee, agent of, or have any financial interest in a laboratory, POCT tester, or IITF for which the MRO is reviewing drug test results.
(b) An MRO must not derive any financial benefit by having an agency use a specific drug testing laboratory, POCT tester, or instrumented initial test facility or have any agreement with the laboratory, POCT tester, or IITF that may be construed as a potential conflict of interest.

(a) After a primary specimen has been reported to the agency, a donor has the right to request through the MRO that the split specimen be tested at an HHS-certified laboratory to confirm the same positive, adulterated, or substituted result that was reported by the laboratory for the primary specimen.
(b) A donor has 72 hours to initiate the request after being informed of the result by the MRO. The donor must document this request in writing to the MRO.

(a) The testing of a split specimen for a drug or metabolite is not subject to the testing cutoff concentrations established for the original testing of a specimen.
(b) The laboratory is only required to provide data that is sufficient to confirm the presence of the drug or metabolite that was reported present in the primary specimen.
(c) If the second laboratory fails to reconfirm the presence of the drug or drug metabolite that was reported by the first laboratory, the second laboratory shall conduct validity tests in an attempt to determine the reason for being unable to reconfirm the presence of the drug or drug metabolite. The second laboratory should conduct the same validity tests as it would conduct on a primary specimen and reports those results to the MRO. If the second laboratory fails to determine that the split specimen is adulterated or substituted, the MRO may request the second laboratory to transmit the split specimen to another HHS-certified laboratory for further testing. If the second laboratory determines that the split specimen is adulterated or substituted, the MRO must direct the primary laboratory to test the primary specimen for the adulterant or substitution that was identified by the second laboratory for the split specimen.

(a) A second laboratory shall use one of the following criteria to reconfirm an adulterated result when testing a split (Bottle B) specimen:

(1) pH shall be measured using the laboratory's confirmatory pH test with the appropriate cutoff (i.e., either less than 3 or greater than or equal to 11);
(2) Nitrite shall be measured using the laboratory's confirmatory nitrite test with a cutoff concentration of greater than or equal to 500 mcg/mL; or
(3) For adulterants without a specified cutoff (e.g., glutaraldehyde, surfactant, chromate, pyridine, halogens (such as, bleach, iodine), peroxidase, peroxide, other oxidizing agents), the laboratory shall use its confirmatory validity test at an established limit of detection (LOD)/limit of quantitation (LOQ) to reconfirm the presence of the adulterant.

(b) The second laboratory may only conduct the confirmatory validity test(s) needed to reconfirm the adulterant result reported by the primary laboratory.

(a) A second laboratory shall use the following criteria to reconfirm a substituted result when testing a split (Bottle B) specimen:

(1) The creatinine shall be measured using the laboratory's confirmatory creatinine test with a cutoff concentration of less than 5 mg/dL; and
(2) The specific gravity shall be measured using the laboratory's confirmatory specific gravity test with the specified cutoffs of less than 1.002 or greater than or equal to 1.020.

(b) The second laboratory may only conduct the confirmatory validity test(s) needed to reconfirm the validity test result(s) reported by the primary laboratory.

(a) The MRO must cancel the test and inform the agency that an immediate collection of another specimen is permitted in order to obtain a valid test result.
(b) The MRO or agency contacts the appropriate regulatory office with details of the failure to reconfirm that are needed by the regulatory office to conduct an investigation into the cause of the failure to reconfirm.

(a) The following problems are considered to be fatal flaws:

(1) The specimen ID number on the specimen received by the laboratory does not match the number on the CCF;
(2) There is no specimen ID number on the specimen received by the laboratory;
(3) There is no printed collector's name and no collector's signature on the CCF;
(4) The tamper-evident seal on the specimen is received broken; or
(5) There is insufficient specimen to conduct the required analyses.

(b) A specimen received with a fatal flaw must not be tested and the reason is reported to the MRO.

(a) The following problems are considered to be correctable errors:

(1) The collector failed to sign the CCF; or
(2) The collector failed to check the specimen temperature box and the "Remarks" line did not have a comment regarding the temperature being out of range.

(b) When either error occurs, the laboratory must request the collector to provide a written memorandum for record (MFR) attesting to the fact that he or she inadvertently forgot to properly document the CCF.
(c) If the collector's signature cannot be corrected by an MFR, the laboratory must report the specimen rejected for testing and provide a reason on the report.
(d) If the collector cannot provide an MFR to attest to the fact that he or she did measure the specimen temperature, the laboratory may report the test result for the specimen but indicate that the collector could not provide an MFR to recover the omission.

(a) The following errors, omissions, and discrepancies on the CCF that is received by the laboratory are considered insignificant and should not cause a laboratory to reject a specimen or cause an MRO to cancel a test:

(1) An incorrect laboratory name and address appears at the top of the form;
(2) Incomplete/incorrect/unreadable employer name or address;
(3) MRO name is missing;
(4) Incomplete/incorrect MRO address;
(5) A transposition of numbers in the donor's SSN;
(6) A phone number is missing/incorrect;
(7) A fax number is missing/incorrect;
(8) A "reason for test" box is not marked;
(9) A "drug tests to be performed" box is not marked;
(10) A specimen collection box is not marked;
(11) The observed box is not marked (if applicable);
(12) The collection site address is missing;
(13) The time of collection is not indicated;
(14) The date of collection is not indicated;
(15) Incorrect name of delivery service; or
(16) The donor's name inadvertently appears on the laboratory copy of the CCF or on the tamper-evident labels used to seal the specimen bottles.

(b) The following errors, omissions, and discrepancies on the CCF that are made at the laboratory are considered insignificant and should not cause an MRO to cancel a test:

(1) The testing laboratory fails to indicate the correct name and address in the results section when a different laboratory name and address is printed at the top of the CCF;
(2) The accessioner fails to print his or her name;
(3) The certifying scientist fails to print his or her name;
(4) The certifying scientist accidently initials the CCF rather than providing a signature for a non-negative result (CS initials are acceptable for a negative result);
(5) The accessioner fails to mark one of the "primary specimen bottle seal intact" boxes, but the laboratory reported a "rejected for testing" result with an appropriate comment on the "Remarks" line.

(c) The above errors, omissions, and discrepancies are considered insignificant only when they occur less than one percent of the time. The expectation is that each trained collector and certified laboratory will make every effort to ensure that the CCF is properly completed and that all the information is correct. When an error occurs more than one percent of the time, the MRO must direct the collector or laboratory (whichever is responsible for the error) to immediately take corrective action to prevent the recurrence of the error.

(a) An MRO must attempt to correct the following errors:

(1) The donor's signature is missing on the MRO copy of the CCF and the collector failed to provide a comment that the donor refused to sign the form;
(2) The certifying scientist failed to sign the hard copy (Copy 1) of the CCF for a specimen being reported drug positive, adulterated, substituted, rejected for testing, or invalid test result; or
(3) The electronic report provided by the laboratory does not contain all the data elements required for the HHS standard electronic laboratory report for a specimen being reported drug positive, adulterated, substituted, rejected for testing, or invalid test result.

(b) If error (a)(1) occurs, the MRO must contact the collector to obtain a statement to verify that the donor refused to sign the MRO copy. If the collector cannot provide such a statement, the MRO must cancel the test.
(c) If error (a)(2) occurs, the MRO must obtain a statement from the CS that he or she inadvertently forgot to sign the CCF, but did, in fact, properly conduct the certification review.
(d) If error (a)(3) occurs, the MRO must contact the laboratory and require the laboratory to modify its electronic reports and to retransmit a corrected electronic report.

(a) When there is reason to believe that immediate action is necessary to protect the interests of the United States and its employees (i.e, imminent harm).
(b) The existence of imminent harm may be identified through PT programs, inspection programs, blind samples, or information obtained by an MRO.

(a) When there is evidence that the laboratory or IITF is unable to ensure either the reliability and accuracy of drug tests or the accurate reporting of test results.
(b) The following reasons may be considered in revoking a laboratory's or IITF's certification:

(1) Unsatisfactory performance in analyzing and reporting a donor drug test result;
(2) Unsatisfactory participation in the HHS certification program;
(3) Violation of a Federal agency contract;
(4) Conviction of a criminal offense; or
(5) Any other cause which affects the ability of the laboratory to ensure the full reliability and accuracy of donor drug test results.

(a) The Administrator, SAMHSA, or the Administrator's designee (e.g., Director, Division of Workplace Programs) notifies a laboratory or IITF in writing that its certification is suspended and it must cease testing regulated specimens.
(b) The laboratory or IITF has 5 calendar days from the date of the notification to respond in writing with a plan to take corrective action to prevent the recurrence of the error that caused the laboratory or IITF to be suspended.
(c) The laboratory's or IITF's plan of corrective action will be reviewed and a determination made as to its acceptability in correcting the problem.
(d) The laboratory or IITF will be required to submit revised plans of corrective action until a plan is determined to be acceptable.
(e) After the approved corrective action plan has been completed, the laboratory must submit in writing a letter, including appropriate supporting documents.
(f) If the supporting documents and corrective action are complete, the Administrator's designee will recommend lifting the laboratory's suspension.

(a) The Administrator, SAMHSA, or the Administrator's designee (e.g., Director, Division of Workplace Programs) notifies a laboratory or IITF in writing that there is a proposal to revoke its certification.
(b) The laboratory or IITF has 30 calendar days from the date of the notification to respond in writing with a plan to take corrective action to prevent the recurrence of the error(s) that caused the proposal to revoke the laboratory's or IITF's certification.
(c) The laboratory's or IITF's plan of corrective action will be reviewed and a determination made as to its acceptability in correcting the error(s).
(d) The laboratory or IITF will be required to submit revised plans of corrective action until a plan is determined to be acceptable.
(e) After the approved corrective action plan has been completed, the laboratory or IITF must submit in writing a letter, including appropriate supporting documents.
(f) If the supporting documents and corrective action are complete, the Administrator's designee will recommend removing the proposal to revoke the laboratory's or IITF's certification.
(g) If a laboratory or IITF refuses to submit a plan of corrective action, the laboratory's or IITF's certification will be revoked immediately.

(a) A notice is published in the Federal Register listing the name and address of any certified laboratory or IITF 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.