Initial Test Each Batch Of Specimens example essay topic

NOTE: This draft document represents a joint effort by the SAMHSA / CSAP Division of Workplace Programs and members of the SAMHSA Drug Testing Advisory Board (DTAB). It has not been reviewed by all members of the DTAB, by industry working groups, or by other Federal agencies. This draft document is the first release to a wider audience. It will serve as the basis for developing the guidelines for Federal Workplace Drug Testing Programs. All interested parties are invited to comment on the draft document. Comments may be mailed to the Division of Workplace Programs, 5600 Fishers Lane, Rockwall II, Suite 815, Rockville, Maryland 20857, by fax (301-443-3031), or by email: mailto: or mailto: Please submit your comments by July 12, 2000, to ensure they are considered prior to the September Drug Testing Advisory Board meeting.

MANDATORY GUIDELINES for FEDERAL WORKPLACE DRUG TESTING PROGRAMS Subpart A - Applicability Sec. 1.1 Whom do these Guidelines cover 1.2 Who is responsible for developing and issuing authoritative interpretations of the Guidelines 1.3 How is an exemption granted from these Guidelines 1.4 How are these Guidelines revised 1.5 What do the terms used in these Guidelines mean Subpart B - Specimens 2.1 What types of specimens may be collected 2.2 Under what circumstances can the different types of specimens be collected Subpart C - Drugs 3.1 For which drugs can a specimen be tested 3.2 Can a specimen be tested for other drugs 3.3 Can a specimen be used for other purposes 3.4 What is the cutoff concentration for each drug by type of specimen collected Subpart D - Collectors 4.1 Who may collect a specimen 4.2 What training and certification must a collector have 4.3 Who can trai and certify a collector 4.4 Under what circumstances must a collector be retrained 4.5 What are the collector monitoring and support requirements for organizations employing collectors Subpart E - Collection Sites 5.1 Where can a collection for a drug test take place 5.2 What are the requirements for a collection site 5.3 How long must collection site records be stored 5.4 How does the collector ensure the security of a specimen at the collection site 5.5 What are the privacy considerations when collecting a specimen 5.6 What supplies are needed at the collection site 5.7 How do you protect the privacy of a donor at the collection site Subpart F - Federal Drug Testing Custody and Control Forms 6.1 What form is used to document collecting a specimen 6.2 What happens if an approved form is not available or is not used Subpart G - Collection Device 7.1 What is a collection device 7.2 Must the collection device be cleared by the FDA Subpart H - Specimen Collection Procedure 8.1 What must the collector do before starting the collection procedure 8.2 What are the basic requirements for collecting any type of specimen 8.3 Where can I find the collection procedure for each type of specimen Subpart I - National Laboratory Certification Program 9.1 What is the National Laboratory Certification Program (NLCP) 9.2 How does a laboratory apply to the NLCP 9.3 What is a performance testing (PT) sample 9.4 What are the performance testing requirements for an applicant laboratory 9.5 What are the performance testing requirements for a certified laboratory 9.6 What are the inspection requirements for an applicant laboratory 9.7 What are the inspection requirements for a certified laboratory 9.8 Who may inspect a laboratory participating in the NLCP 9.9 What happens if a laboratory does not satisfy the minimum requirements for either the PT program or the inspection program 9.10 Where is a list of certified laboratories published Subpart J - Blind Samples Submitted by an Agency 10.1 What are the requirements for a blind sample 10.2 What are the requirements for Federal agencies to submit blind samples 10.3 How is a blind sample submitted to the laboratory 10.4 What happens if an inconsistent result is reported on a blind sample Subpart K - Laboratory Requirements 11.1 What is a Standard Operating Procedure Manual 11.2 What qualifications must the laboratorys responsible person (RP) have 11.3 What are the responsibilities of the RP 11.4 What qualifications and training must an individual have to certify a drug test result that is reported by a laboratory 11.5 What qualifications and training must other laboratory personnel have 11.6 What security measures must a laboratory maintain 11.7 How must a laboratory handle a specimen or an aliquot 11.8 What is an initial test 11.9 What must a laboratory do to validate an initial test method 11.10 Why must the initial test be calibrated 11.11 What are the quality control requirements when conducting an initial test 11.12 What is a confirmatory test 11.13 What must a laboratory do to validate a confirmatory test method 11.14 Why must the confirmatory test be calibrated 11.15 What are the quality control requirements when conducting a confirmatory test 11.16 Is a laboratory allowed to conduct any additional tests on a specimen 11.17 What are the requirements for a laboratory to report the test result for a specimen 11.18 How long must a laboratory retain a specimen 11.19 How long must a laboratory retain records 11.20 Can a laboratory store records electronically 11.21 What summary report must a laboratory provide to a Federal agency 11.22 What information is available to the donor 11.23 What type of relationship is prohibited between a laboratory and an MRO 11.24 What information must a certified laboratory provide to its private sector clients Subpart L - Point of Collection Test (POCT) 12.1 What is a point of collection test 12.2 What types of POCT devices are there 12.3 What are the requirements for a POCT device 12.4 Who may conduct a POCT 12.5 What are the qualifications for the person who performs a POCT 12.6 What are the responsibilities of a responsible technician 12.7 Which specimen types may be tested using a POCT 12.8 What are the cutoff concentrations when using a POCT 12.9 May the donor observe the POCT being performed 12.10 What are the requirements for conducting a POCT 12.11 What are the quality control requirements when conducting a POCT 12.12 What are the application requirements for a POCT provider 12.13 What are the qualitative and quantitative specifications for PT samples that are used to evaluate a POCT provider 12.14 What are the inspection requirements for a POCT provider 12.15 Who may inspect a POCT provider 12.16 What happens if a POCT provider does not satisfy the minimum inspection requirements 12.17 Where is a list of "recognized" POCT providers published 12.18 Is a POCT provider allowed to conduct any additional tests on a specimen 12.19 How long must a POCT provider retain a specimen 12.20 How long must a POCT provider retain records 12.21 Can a POCT provider store records electronically 12.22 What summary report must a Federal agency receive from a POCT provider 12.23 What type of relationship is prohibited between a POCT provider and a Medical Review Officer 12.24 What type of relationship can exist between a POCT provider and an HHS certified laboratory 12.25 What security measures must a POCT provider maintain 12.26 What information is available to the donor 12.27 What is the minimum specimen volume for a POCT 12.28 What action may a Federal agency take when a POCT is positive 12.29 How is the POCT result reported to the Medical Review Officer Subpart M -Instrumented Initial Test Facility 13.1 What is an instrumented initial test facility 13.2 Are laboratories that perform only initial tests allowed 13.3 What is an instrumented initial test 13.4 What types of initial tests are there 13.5 What are the requirements for an instrumented initial test facility 13.6 Why must the instrumented initial test device be calibrated 13.7 Who may conduct an instrumented initial test 13.8 What are the qualifications for the person who performs an instrumented initial test 13.9 What are the responsibilities of a responsible technician 13.10 Which specimen types may be tested using an instrumented initial test 13.11 What are the cutoff concentrations when using an instrumented initial test 13.12 What are the quality control requirements when conducting an instrumented initial test 13.13 What are the application requirements for an instrumented initial test facility 13.14 What are the qualitative and quantitative specifications for PT samples that are used to evaluate an instrumented initial test facility 13.15 What are the inspection requirements for an instrumented initial test facility 13.16 Who may inspect an instrumented initial test facility 13.17 What happens if an instrumented initial test facility does not satisfy the minimum inspection requirements 13.18 Where is a list of "recognized" instrumented initial test facilities published 13.19 Is an instrumented initial test facility allowed to conduct any additional tests on a specimen 13.20 How long must an instrumented initial test facility retain a specimen 13.21 How long must an instrumented initial test facility retain records 13.22 Can an instrumented initial test facility store records electronically 13.23 What summary report must a Federal agency receive from an instrumented initial test facility 13.24 What type of relationship is prohibited between an instrumented initial test facility and a Medical Review Officer 13.25 What type of relationship can exist between an instrumented initial test facility and an HHS certified laboratory 13.26 What security measures must an instrumented initial test facility maintain 13.27 What is the minimum specimen volume collected for an instrumented initial test 13.28 What action may a Federal agency take when an instrumented initial test is reported as a non-negative 13.29 How is the instrumented initial test result reported to the Medical Review Officer Subpart N - Medical Review Officer (MRO) 14.1 Who may serve as an MRO 14.2 What are the responsibilities of an MRO 14.3 What type of relationship is prohibited between an MRO and a laboratory, POCT provider, or an instrumented initial test facility Subpart O - Single Specimen Retests and Split Specimen Tests 15.1 When may a single specimen or primary specimen be retested 15.2 When may a split specimen be tested 15.3 How does a laboratory handle the retesting of a single specimen or the testing of a split specimen 15.4 Who receives the single specimen retest result or the split specimen result 15.5 What happens when a single specimen retest or split specimen result does not reconfirm the original test result 15.6 How long must a laboratory retain a split specimen Subpart P - Problems with Drug Tests 16.1 What problems will always result in a laboratory not testing a specimen 16.2 What problems will result in a laboratory not reporting a drug test result unless the problem is corrected Subpart Q - Laboratory Suspension / Revocation Procedures 17.1 When may a certified laboratory be suspended 17.2 When may a laboratorys certification be revoked 17.3 What is the procedure when a laboratory is suspended 17.4 What is the procedure when there is a proposal to revoke a laboratorys certification 17.5 Where are notices of laboratory actions published Authority: Subpart A - Applicability 1.1 Whom do these Guidelines cover These guidelines apply to: (a) Executive Agencies as defined in 5 U.S.C. 105; (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. 1.2 Who is responsible for developing and issuing authoritative interpretations of the Guidelines (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 of 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. These interpretations are the only official and authoritative interpretations that are valid and binding. 1.3 How is an exemption granted from these Guidelines (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. 1.4 How are these Guidelines revised (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. 1.5 What do the terms used in these Guidelines mean The following definitions are adopted: Aliquot A fractional part of a specimen used for testing. It is taken as a sample representing the whole specimen. Adulterated A specimen is considered to be adulterated if it either contains a substance that is not a normal constituent for that type of specimen or contains 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 blind sample is a sample with a known drug concentration or a negative 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 Calibrator A solution of known concentration that is used to define 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 or the POCT provider cannot support reporting either a positive nor a negative test to the employer. Certifying Scientist The individual who is responsible for verifying the forensic and scientific supportability of a test result.

Chain of Custody 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. Chain of Custody Document The form (s) used by the laboratory to document the security of the specimen and all aliquots of the specimens during testing and storage by the laboratory. The form, which may account for an entire test batch, shall include the names and signatures of all individuals who accessed 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 to be analyzed for the presence of drugs. Collector A person who instructs and assists donors at a collection site and receives the specimen provided by the donor. Confirmatory Test An analytical procedure performed on a separate aliquot of the specimen to identify the presence of a specific drug or metabolite.

Control A sample used to evaluate whether or not the analytical procedure is operating within predefined tolerance limits. Cut-off The concentration used to report a specimen as negative or positive. Dilute Refers to a specimen with less than normal constituents. (TO BE DETERMINED FOR EACH SPECIMEN) Donor The individual from whom a specimen is collected.

Failed to Reconfirm The result reported when a laboratory is unable to detect the drug or metabolite that was previously reported from the original analysis. Federal Custody and Control Form An OMB approved form used to document the collection, 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 returned to a testing designated position. HHS The Department of Health and Human Services or designee of the Secretary, Department of Health and Human Services. Initial Test The test used to differentiate a negative specimen from one that requires further testing. Invalid Result The result reported when a laboratory is unable to obtain a scientifically supportable drug test result.

HHS Certified Instrumented Initial Test Facility A location where initial testing, reporting of results, and recordkeeping is performed under the supervision of a responsible technical (RT). HHS Certified Laboratory A location where initial and confirmation testing is performed under the supervision of an RP and Certifying Scientists are used for final review and release of drug testing results. HHS Certified Point of Collection Test Facility A location where specimen collection, initial testing, reporting of results, and record keeping is performed under the supervision of a responsible technician (RT). Medical Review Officer (MRO) A licensed physician who receives, reviews, verifies, and reports the drug test results. Negative Result Result for a specimen that either contains no drug or the concentration of the drug is less than the cutoff concentration for that drug or drug class. Non-Negative Result Result for a specimen from an initial test that must go to confirmation for a final report.

Positive Result Laboratory result for a specimen that contains a drug or metabolite greater than or equal to the cutoff concentration. Post Accident Test A test performed on a specimen collected from a donor after the donor is involved in a job-related accident. Pre-employment Test A test performed on a specimen collected from a donor who is applying for a testing designated position. Quality Control Sample A calibrator, control, and / or blind sample. Random Test A test performed on a specimen collected from a donor who is selected at random from the individuals working in testing designated positions. Reasonable Suspicion / Cause Test (TO BE DETERMINED) Reconfirmed The result reported when a laboratory is able to detect the drug or metabolite that was previously reported from the original analysis.

Rejected for Testing Result for a specimen for which the laboratory or the point of collection test device provider does not perform any tests on the specimen. 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 point of collection test facility or the HHS certified instrumented initial test facility. Return to Duty Test A test performed on a specimen collected from a donor 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 which acts on behalf of the Secretary in implementing these Guidelines).

Specimen Fluid or material derived from the body and which may be subdivided or concomitantly 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 concomitantly 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 simultaneously collected specimens. For sweat, a sweat 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 provided by a donor. Testing Designated Position An employment position within a Federal agency that has been designated for random testing. Subpart B - Specimens 2.1 What types of specimens may be collected A Federal agency may collect the following types of specimens as part of its workplace drug testing program: (a) Urine (b) Oral Fluid (Saliva) (c) Sweat (d) Hair 2.2 Under what circumstances can the different types of specimens be collected Recommended reasons for specimen type selected are as follows: Type of Specimen Reason For Test Urine Pre-employment, random, reasonable suspicion / cause, post accident, return to duty, follow-up Oral Fluid reasonable suspicion / cause, post accident Sweat Return to duty, follow-up Hair Pre-employment, random, follow-up Subpart C - Drugs 3.1 For which drugs can a specimen be tested The Executive Order 12564 defines "illegal drugs" as those included in Schedule I or II of the Controlled Substances Act (CSA), but not when used pursuant to a valid prescription or when used as otherwise authorized by law.

Federal agency drug testing programs must test all specimens for marijuana and cocaine use and may test for use of opiates, amphetamines, and phencyclidine. 3.2 Can a specimen be tested for additional drugs (a) Reasonable suspicion / cause, or post accident specimens may be tested for any drug listed in Schedule I or II of the CSA. (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. 3.3 Can a specimen be used for other purposes (a) Specimens collected pursuant to these Guidelines may be used to test only for those drugs included in the Agency workplace drug testing program. They may not be used to conduct any other analysis or test unless otherwise authorized by the Guidelines. (b) A specimen that tests negative by initial or confirmatory testing may, however, be pooled for use in a laboratory's internal quality control program. (c) 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.

3.4 What is the cutoff concentration for each drug by type of specimen collected Urine Initial Test Cutoff Concentration (ng / m L) Marijuana metabolites... 50 Cocaine metabolites... 150 Opiate metabolites... 2000 Phencyclidine... 25 Amphetamines... 500 Screening must significantly cross-react w / MDMA (Roughly equal cross-reactivity) Confirmatory Test Cutoff Concentration (ng / m L) Marijuana metabolite 1...

15 Cocaine metabolite 2... 100 Opiates Morphine... 2000 Codeine... 2000 6-acetylmorphine... 10 Phencyclidine... 25 Amphetamines d-Amphetamine...

150-250d-Methamphetamine 3... 150-250 MDMA... 150-250 MDA... 150-250 MDEA... 150-250 1 Delta-9-tetrahydrocannabinol-9-carboxylic acid 2 Benzoylecgonine 3 Specimen must also contain Amphetamine at a concentration 100 ng / m L Hair Initial Test Cutoff Concentration (pg / mg ) Marijuana metabolites... 1.0 Cocaine metabolites...

500 Opiate metabolites... 200 Phencyclidine... 300 Amphetamines... 500 Screening must cross-react w / MDMA Confirmatory Test Cutoff Concentration (pg / mg ) Marijuana metabolite 1...

0.05 Cocaine metabolite 2... 100 Cocaine... 1000 BE / COC ratio = 0.1 Opiates Morphine... 200 Codeine... 200 6-acetylmorphine... 200 Hair 6-AM rule (TO BE DETERMINED) Phencyclidine...

300 Amphetamines d-Amphetamine... 300d-Methamphetamine... 300 Hair amp rule... 50 MDMA MDA MDEA 1 Delta-9-tetrahydrocannabinol-9-carboxylic acid 2 Benzoylecgonine Sweat Initial Test Cutoff Concentration Target Analyte (ng/ 2.5 mL eluate) Marijuana metabolites... 1.5 THC Cocaine metabolites...

10 Benzoylecgonine Opiate metabolites... 10 Morphine Phencyclidine... 7.5 Phencyclidine Amphetamines... 10d-Methamphetamine (Amp screening must cross-react w / MDMA) Confirmatory Test Cutoff Concentration (ng/2.5 mL eluate) THC parent drug... 0.5 Cocaine parent drug... 10 Cocaine metabolite 2...

10 Opiates Morphine... 10 Codeine... 10 6-acetylmorphine... 10 Phencyclidine... 7.5 Amphetamines d-Amphetamine...

10d-Methamphetamine 3... 10 MDMA MDA MDEA 2 Benzoylecgonine 3 Specimen must also contain Amphetamine at a concentration (TO BE DETERMINED) ng / m L Oral Fluid Initial Test Cutoff Concentration (ng / m L) Marijuana metabolites... 4 Cocaine metabolites... 20 Opiate metabolites...

40 Phencyclidine... 4 Amphetamines... 160 Screening must cross-react w / MDMA Confirmatory Test Cutoff Concentration (ng / m L) THC Parent drug... 2 Cocaine metabolite 2... 8 Opiates Morphine...

40 Codeine... 40 6-acetylmorphine... 4 Phencyclidine... 2 Amphetamines d-Amphetamine... 160d-Methamphetamine 3... 160 MDMA MDA MDEA 2 Benzoylecgonine 3 Specimen must also contain Amphetamine at a concentration (TO BE DETERMINED) ng / m L Subpart D - Collectors 4.1 Who may collect a specimen (a) An individual trained or certified to collect specimens. (b) The direct supervisor of donor may not act as the collector when that donor is tested, unless no other collector is available.

4.2 What training and certification must a collector have (a) HHS has not established a formal certification program for collectors. However, private sector organizations are encouraged to develop the required certification program. This will help to ensure that collectors have, in fact, been properly trained and certified to collect specimens as required by the Guidelines. (b) To be a collector, you must do the following: (1) Read and become familiar with the collection procedures in these Guidelines; (2) Read and become familiar with the HHS Specimen Collection Handbook for the specimen being collected; and (3) Attain certification through a recognized collector certification program for the type (s) of specimen (s) you are going to collect. (c) As a collector, you must be recertified once every two years to ensure that you are familiar with current HHS specimen collection policies and procedures. (d) As a collector, you must maintain all documentation of certification / recertification as long as you serve as a collector. 4.3 Who can train and certify collectors (TO BE DETERMINED) 4.4 Under what circumstances must a collector be retrained (a) A collector needs to be retrained when: (1) The collection procedure changes significantly (e. g., a new CCF is used); or (2) The collector makes mistakes that cause tests to be canceled. This will lead to a "collectors cancellation rate" being an index of performance. (b) The required retraining: (1) Must be focused in the specific area of collection procedures that caused the tests to be canceled; and (2) Be documented in writing by a trainer. 4.5 What are the collector monitoring and support requirements for organizations employing collectors An organization (e. g., Federal agency, contractor, health clinic) employing the collector must do the following: (a) Have an official certification statement documenting that the collector is certified; (b) Retain these official certification statements as long as the person performs collector functions and for 2 years after the collector leaves the organization; and (c) Provide to a collector the name and telephone number of the Federal agencys representative to contact about problems or issues that may arise during a specimen collection procedure.

Subpart E - Collection Sites 5.1 Where can a collection for a drug test take place (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. 5.2 What are the requirements for a collection site A collection site must have the following: (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) Ability to restrict access to only authorized personnel during the collection; (d) Ability to restrict access to collection supplies; and (e) Ability to store records securely. 5.3 How long must collection site records be stored Collection site records must be stored for a minimum of 2 years. 5.4 How does the collector ensure the security of a specimen at the collection site A collector must do the following to maintain the security of a specimen: (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 specimen; and (e) Immediately seal the specimen. 5.5 What are the privacy considerations when collecting a specimen The requirements for specimen collection are as follows depending on the type of specimen being collected: (a) For urine, the donor must have visual privacy while providing the specimen unless: (1) There is a reason to believe that the donor may alter or substitute the specimen to be provided; or (2) A direct observed collection was authorized. (b) For hair, head hair is collected unless it is not available. Collection of hair from other areas of the body must be approved in accordance with Agency procedures before the collection and must be collected using appropriate privacy. (c) For sweat, the sweat patch will be applied by the collector to the donors upper arm, chest, or back.

The donor must be allowed privacy during the application and removal of the patch by the collector. (d) For oral fluid, the collection device must be inserted into and removed from the donors mouth by the donor in the presence of the collector. The donor will be observed by the collector during this entire process. (e) A complete description of collection procedures for each specimen are in the HHS Specimen Collection Handbook for Federal Workplace Drug Testing Programs. 5.6 What supplies are needed at the collection site (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: Subpart F - Federal Drug Testing Custody and Control Forms 6.1 What form is used to document a specimen collection (a) An Office of Management and Budget (OMB) approved Federal Drug Testing Custody and Control Form (CCF) must be used to document the collection of a specimen at the collection site. (b) The form is used to document chain of custody from the time a donor gives the specimen to the collector until the specimen is received for testing. (c) The CCF used for each type of specimen collected is available from a number of different sources. A sample of the OMB approved CCF for each type of specimen is available at the following website: (d) Federal agencies and employers regulated by the Department of Transportation (DOT) are required to use the OMB approved Federal CCF for their workplace drug testing programs. 6.2 What happens if an approved form is not available or is not used (a) When the collector either by mistake or as the only means to conduct a test under difficult circumstances (e. g., post accident test with insufficient time to obtain the CCF) uses a non-Federal form for a regulated collection, the use of a non-Federal form is not a reason for the laboratory to reject the specimen for testing or for the MRO to cancel the test. (b) If the testing facility or the MRO discovers the use of the incorrect form, a signed statement must be obtained from the collector stating the reason why the Federal CCF was not used for the regulated collection. Subpart G - Collection Device 7.1 What is a collection device (a) A collection device is considered to be the following for each type of specimen collected: (1) For urine, it is the single-use plastic specimen container and / or bottle.

(2) For hair, it is the foil and single-use plastic bag in which the hair sample is placed. (3) For oral fluid, it is the applicator, pad, or aspirator placed in the oral cavity. (4) For sweat, it is the patch that is placed on the skin. (b) A collection device must not affect or alter the specimen collected. The supplier of a collection device must evaluate the device to ensure that it does not affect the specimen collected. (c) A collection device must have the capability of being sealed by the collector to prevent unauthorized access to the specimen while at the collection site. 7.2 Must the collection device be cleared by the FDA (a) If the collection device is a unique and integral part of the collection procedure and the analytical testing procedure, it must be cleared by the FDA as a medical device. (b) Single-use items (such as, plastic bottles, plastic bags, foil) are not unique collection devices and, therefore, are not required to be cleared by the FDA. (c) The sweat patch (sweat) and applicator, pad, or aspirator (oral fluid) are unique and integral to collecting a valid specimen and must be FDA cleared. Subpart H - Specimen Collection Procedure 8.1 What must the collector do before starting the collection procedure The collector must do the following before starting the collection procedure: (a) Verify the donors identification; (b) Provide your identification to the donor if the donor asks; (c) Explain the basic collection procedure to the donor; (d) Request the donor to read the instructions on the back of the CCF; and (e) Answer any questions the donor may have regarding the collection procedure.

8.2 What are the basic requirements for collecting any type of specimen The basic requirements are as follows: (a) The donor removes any unnecessary outer garments (such as, a coat or jacket). (b) The donor washes and dries his or her hands prior to handling the collection device. After washing hands, the donor must remain in the presence of the collector and must not have access to anything that could be used to affect the specimen. (c) The collector and donor observe the selection and opening of the collection device used to collect the specimen. (d) After a specimen is collected, the collector inspects the specimen for signs of tampering. (e) A specimen suspected of being tampered with is sent to the laboratory for testing. (f) The collector must get permission to immediately collect another specimen when a tampered specimen is collected. This second specimen must also be sent to the laboratory. (g) The collector and donor must keep the specimen in view at all times prior to sealing the collection device. (h) A tamper-evident label / seal must be used to secure the collection device. (i) The donor must initial the label and the collector must date the label after it is used to secure the collection device. (j) The collector must complete the CCF and distribute each copy as required. 8.3 Where can I find the collection procedure for each type of specimen (a) A complete description of the collection procedure used to collect each type of specimen is in the HHS Specimen Collection Handbook for Federal Workplace Drug Testing Programs. (b) The handbook is available on the following website: Subpart I - National Laboratory Certification Program 9.1 What is the National Laboratory Certification Program (NLCP) (a) The National Laboratory Certification Program (NLCP) is the program established by HHS to certify laboratories before they are permitted to test specimens that are collected for Federal agency or federally regulated workplace drug testing programs.

The NLCP includes a performance testing (PT) program and a laboratory inspection program. (b) An applicant laboratory is required to pass 3 consecutive sets of initial PT samples and an initial inspection before becoming HHS certified. (c) An HHS certified laboratory is required to test quarterly sets of maintenance PT samples, undergo an inspection 3 months after being certified, and undergo semiannual maintenance inspections thereafter. (d) A laboratory must meet all the pertinent provisions of these Guidelines in order to qualify for and maintain certification. The Secretary has broad discretion to take appropriate action to ensure the full reliability and accuracy of drug testing and reporting, to resolve problems related to drug testing, and to enforce all standards set forth in these Guidelines. The Secretary has the authority to issue directives to any laboratory suspending the use of certain analytical procedures when necessary to protect the integrity of the testing process; ordering any laboratory to undertake corrective actions to respond to material deficiencies identified by an inspection or through proficiency testing; ordering any laboratory to send aliquots of specimens to another laboratory for retesting when necessary to ensure the accuracy of testing under these Guidelines; ordering the review of results for specimens tested under the Guidelines for private sector clients to the extent necessary to ensure the full reliability of drug testing for Federal agencies; and ordering any other action necessary to address deficiencies in drug testing, analysis, specimen collection, chain of custody, reporting of results, or any other aspect of the certification program. 9.2 How does a laboratory apply to the NLCP (a) A laboratory interested in becoming an HHS certified laboratory must submit an NLCP application form. (b) The application form requires the applicant laboratory to provide detailed information on both the administrative and analytical procedures the laboratory proposes to use for testing regulated specimens after it is certified. (c) The NLCP application form is available at the following website: 9.3 What is a PT sample (a) A PT sample is a sample that may contain: (1) The drugs and / or metabolites in the drug classes that each laboratory must have the capability to test for; (2) Both the parent drug and / or its major metabolite (s); or (3) More than one drug class (but generally no more than two drug classes) to imitate real donor specimens. (b) The concentration of the drugs and / or metabolites in a PT sample may be: (1) At least 20 percent above the cutoff concentration for either the initial test or the confirmatory test (depending on which is to be evaluated); (2) As low as 40 percent of the cutoff concentration when the PT sample is designated as a retest sample; or (3) At another concentration for a special purpose. (c) A negative PT sample may not contain a measurable amount of a target drug and / or metabolite. (d) A PT sample may contain an interfering substance (s). (e) For each PT cycle, the set of PT samples going to each laboratory will vary but, within each calendar year, each laboratory will have analyzed the same total set of samples. (f) The laboratory must, to the greatest extent possible, handle, test, and report a PT sample in a manner identical to that used for a donor specimen, unless otherwise specified. 9.4 What are the performance testing requirements for an applicant laboratory An applicant laboratory must satisfy the following criteria on 3 consecutive sets of initial PT samples: (a) No false positive results; (b) Correctly identify and confirm 90 percent of the total drug challenges on the 3 sets of samples; (c) The quantitative values for at least 80 percent of the total drug challenges must be within 20 percent of the calculated reference group mean; (d) No quantitative value on a drug concentration may differ by more than 50 percent from the calculated reference group mean; and (e) For an individual drug, correctly detect and quantify at least 50 percent of the total drug challenges. 9.5 What are the performance testing requirements for a certified laboratory A certified laboratory must satisfy the following criteria on the maintenance PT samples to maintain its certification: (a) Correctly identify and confirm 90 percent of the total drug challenges over two consecutive PT cycles; (b) Correctly quantify 80 percent of the total drug challenges within 20 percent of the appropriate reference or peer group mean as measured over two consecutive PT cycles; (c) Have no more than one quantitative result differ more than 50 percent from the target value over two consecutive PT cycles; and (d) For any individual drug, correctly detect and quantify at least 50 percent of the total drug challenges.

9.6 What are the inspection requirements for an applicant laboratory (a) An applicant laboratory is inspected by a team of at least two inspectors. (b) Each inspector conducts an independent evaluation and review of all aspects of the laboratorys procedures and facilities using the guidance provided by the Secretary and the National Laboratory Certification Program inspection checklist. (c) To become certified, an applicant laboratory must satisfy the minimum requirements as stated in these Guidelines. 9.7 What are the inspection requirements for a certified laboratory (a) It must undergo an inspection 3 months after becoming certified and then inspected semiannually thereafter. (b) A certified laboratory is inspected by a team of at least two inspectors. The number of inspectors required is dependent on the workload of the laboratory. (c) Each inspector conducts an independent evaluation and review of all aspects of the laboratorys procedures and facilities using the guidance provided by the Secretary and the National Laboratory Certification Program inspection checklist. (d) To remain certified, a laboratory must continue to satisfy the minimum requirements as stated in these Guidelines. 9.8 Who may inspect a laboratory participating in the NLCP (a) The Secretary, a Federal agency using a certified laboratory, or the contractor awarded the HHS NLCP contract may inspect a laboratory at any time. (b) An individual may serve as an NLCP inspector if he or she satisfies the following criteria: (1) Has experience and an educational background similar to that required for either the responsible person or the certifying scientist as described in subpart K; (2) Has read and thoroughly understands the policies and requirements contained in these Guidelines and in other NLCP documents; (3) Submits a resume and documentation of qualifications to HHS; (4) Attends NLCP approved training; and (5) Submits an acceptable inspection report and has acceptable performance as a trainee on an inspection. 9.9 What happens if a laboratory does not satisfy the minimum requirements for either the PT program or the inspection program (a) If an applicant laboratory fails to satisfy the requirements established for the initial certification process, the applicant laboratory must start the initial certification process from the beginning. (b) If a certified laboratory fails to satisfy the minimum requirements, the laboratory is given a period of time (e. g., 5 or 30 working days depending on the nature of the issue) to provide any explanation for its performance and evidence that any deficiency has been corrected. (c) A laboratory's certification may be revoked, suspended, or no further action taken depending on the seriousness of the errors and whether there is evidence that any deficiency has been corrected and that current performance meets the requirements for a certified laboratory. (d) A certified laboratory may be required to undergo a special inspection or to test additional PT samples, depending on the nature of the performance, to verify that any deficiency has been corrected. (e) If a laboratory's certification is revoked or suspended, the laboratory is not permitted to test specimens for Federal agencies or federally regulated employers until the suspension is lifted or the laboratory has successfully completed the certification requirements as a new applicant laboratory.

9.10 Where is a list of certified laboratories published (a) A list of HHS certified laboratories is published monthly in the Federal Register. (b) Applicant laboratories are not included in the list. Subpart J - Blind Samples Submitted by an Agency 10.1 What are the requirements for a blind sample (a) A blind sample must be validated as to its content by the supplier using initial and confirmatory tests. (b) The supplier must provide information regarding the shelf life of the blind sample. (c) If the blind sample is positive, the concentration of the drug it contains must be at least 25 percent above the cutoff concentration for that drug. 10.2 What are the requirements for Federal agencies to submit blind samples (a) Each Federal agency is required to have both negative and positive blind samples submitted with its donor specimens. (b) During the initial 90-day period of any new Federal agency drug testing program, the agency must ensure that at least 5 percent of the total number of donor specimens submitted are blind samples. (c) After the initial 90-day period, the Federal agency must ensure that a minimum of 3 percent of the total number of donor specimens are blind samples. (d) Approximately 80 percent of the blind samples may be negative (i. e., certified to contain no drug) and the remaining positive for one or more drugs. (e) Each positive sample must be spiked only with those drugs for which the Federal agency is testing. 10.3 How is a blind sample submitted to the laboratory (a) A blind sample is either purchased by the Federal agency and given to the collector or the collector purchases the blind sample from a supplier and submits the blind sample with the Federal agencys donor specimens. (b) A blind sample is always submitted using the same CCF as used for a donor specimen. The collector provides the required information to ensure that the CCF has been properly completed as well as providing fictitious initials on the specimen bottle label / seal. Since there is no donor, the collector must indicate that the sample is a "blind sample" on the MRO copy where the donor would normally provide a signature. (c) Each Federal agency must ensure that the required blind samples are distributed throughout the total number of donor specimens rather than submitted as a single group of samples.

10.4 What happens if an inconsistent result is reported on a blind sample The Medical Review Officer (MRO) is generally the individual who finds that a laboratory has reported an inconsistent result on a blind sample. When such a result is identified: (a) The MRO must notify both the Federal agency and the Federal office responsible for maintaining the NLCP; and (b) The Federal office responsible for the NLCP will initiate an investigation to determine the cause of the error and send a report to the MRO and the Federal agency describing the investigation and corrective action taken. Subpart K - Laboratory Requirements 11.1 What is a Standard Operating Procedure Manual (a) An HHS certified laboratory must have a standard operating procedure (SOP) manual that describes, in detail, all laboratory operations. When followed, it ensures that all specimens are tested using the same procedures and in a consistent manner. The SOP manual must include, but is not limited to, a detailed description of the following: (1) Chain-of-custody procedures; (2) Accessioning; (3) Security; (4) Quality control / quality assurance programs; (5) Analytical methods and procedures; (6) Equipment and maintenance programs; (7) Personnel training; (8) Reporting procedures; and (9) Computers, software, laboratory information management systems (b) All procedures in the SOP manual must be in compliance with these Guidelines and NLCP Program Documents. (c) A copy of all procedures that have been replaced or revised and the dates on which they were in effect must be maintained to allow the laboratory to retrieve the procedures that were used to test a specimen.

11.2 What qualifications must the laboratorys responsible person (RP) have A certified laboratory must have at least one individual who can assume the professional, organizational, educational, and administrative responsibilities for the entire drug testing facility. The minimum qualifications for the RP are as follows: (a) Certified as a laboratory director by the State in forensic or clinical laboratory toxicology; or have a Ph. D. in one of the natural sciences with an adequate undergraduate and graduate education in biology, chemistry, pharmacology, or toxicology; or have training and experience comparable to a Ph. D. in one of the natural sciences with additional training and laboratory / research experience in biology, chemistry, pharmacology, or toxicology; and (b) Have appropriate experience in analytical forensic toxicology with emphasis on the collection and analysis of biological specimens for drugs of abuse; and (c) Have appropriate training and / or experience in forensic applications of analytical toxicology, e. g., publications, court testimony, research concerning analytical toxicology of drugs of abuse, or other factors which qualify the individual as an expert witness in forensic toxicology. 11.3 What are the responsibilities of the RP The RP must fulfill the following responsibilities: (a) Manage the day-to-day operations of the drug testing laboratory even where another individual has overall responsibility for an entire multi-specialty laboratory. (b) Ensure that there are enough personnel with adequate training and experience to supervise and conduct the work of the drug testing laboratory. The RP must ensure the continued competency of laboratory personnel by documenting their in-service training, reviewing their work performance, and verifying their skills. (c) Maintain a complete, current SOP manual that is available for personnel performing tests, and followed by those personnel. The SOP manual must be reviewed, signed, and dated by the RP whenever procedures are first placed into use or changed or when a new individual assumes responsibility for management of the drug testing laboratory. (d) Maintain a quality assurance program to assure the proper performance and reporting of all test results; monitor acceptable analytical performance for all controls and standards; monitor quality control testing; document the validity, reliability, accuracy, precision, and performance characteristics of each test and test system. (e) Implement all remedial actions necessary to maintain satisfactory operation and performance of the laboratory in response to quality control systems not being within performance specifications, errors in result reporting or in analysis of performance testing results. This individual must ensure that sample results are not reported until all corrective actions have been taken and he or she can assure that the results provided are accurate and reliable. (f) Qualify as a certifying scientist for both initial and confirmatory test results.

11.4 What qualifications and training must an individual have to certify a drug test result that is reported by a laboratory (a) A certifying scientist (CS) must have the following qualifications: (1) A bachelor's degree in the chemical or biological sciences, medical technology, or equivalent; (2) Training and experience in the analytical methods and procedures used by the laboratory that are relevant to the results that the individual certifies; and (3) Training and experience in reviewing and reporting test results, maintenance of chain of custody, and understanding proper remedial action in response to problems that may arise. (b) A laboratory must have at least one individual who is designated as a CS. (c) There are two types of certifying scientists: (1) A negative CS who is qualified to certify only results that are negative on the initial test; and (2) A CS who is qualified to certify results for both initial and confirmatory test results. 11.5 What qualifications and training must other laboratory personnel have (a) All laboratory staff (e. g., technicians, administrative staff) must have the appropriate training and skills for the tasks assigned. (b) Each individual working in a certified laboratory must be properly trained before he or she is permitted to work independently in any area of the laboratory. (c) The training file for each individual must include, at a minimum, resumes, documentation of training provided, and any applicable professional certifications / licenses. Training files may be maintained separate from personnel files. 11.6 What security measures must a laboratory maintain (a) A laboratory must control access to the drug testing facility and ensure that no unauthorized individual can gain access to specimens, aliquots, or records. (b) A laboratory must maintain a record that documents the dates, time of entry and exit, and purpose of entry of authorized visitors accessing secured areas. (c) With the exception of personnel authorized to conduct inspections on behalf of Federal, state, or other accrediting agencies for which the laboratory is testing specimens or on behalf of the Secretary or emergency personnel (e. g., firefighters and medical rescue teams), all authorized visitors must be escorted at all times. 11.7 How must a laboratory handle a specimen or an aliquot (a) A laboratory must use chain of custody procedures to document the receipt, handling, and transfer of a specimen or an aliquot throughout the testing process and until final disposition. (b) Chain of custody must be documented by using either hard copy procedures or electronic procedures. (c) Chain of custody documentation must be completed at the time of the transaction. 11.8 What is an initial test (a) An initial test is a test used to differentiate a "negative" specimen from those that require further testing. (b) An initial test may include, but is not limited to, the following techniques: immunoassay or chromatographic separation coupled with an appropriate detector. (c) An initial test must be validated by the laboratory before it is used to test donor specimens.

11.9 What must a laboratory do to validate an initial test method (a) The validation procedure must demonstrate: (1) The ability to differentiate positive and negative samples; (2) The performance of the test around the cutoff concentration; and (3) The performance of the test results at several concentrations between 0 and 150 percent of the cutoff concentration. (b) A laboratory may conduct a second initial test prior to the confirmatory test. If the laboratory uses a second initial test, the second initial test is subject to the same requirements as the first initial test. 11.10 Why must the initial test be calibrated The initial test must be calibrated to ensure and document the linearity of the assay method over time in the concentration area of the cutoff. 11.11 What are the quality control requirements when conducting an initial test (a) Each batch of specimens must contain the following types of QC samples: (1) At least one control certified to contain no drug or metabolite; (2) At least one control that has the concentration of the drug or metabolite at 25 percent above the cutoff concentration; (3) At least one control that has the concentration of the drug or metabolite at 25 percent below the cutoff concentration; and (4) At least one blind control (or a minimum of 1 percent) inserted to appear as a donor specimen to the laboratory analysts. (b) At least 10 percent of the batch must be calibrators and controls. (c) A laboratory must establish a procedure to ensure that any carryover that might occur between aliquots during the initial testing is detectable and corrected. 11.12 What is a confirmatory test (a) A confirmatory test is an analytical procedure performed on a separate aliquot of the specimen to identify the presence of a specific drug or metabolite. (b) The procedure used must combine chromatographic separation and mass spectrometric identification in the same procedure (e. g., GC / MS, LC / MS, GC / MS/MS, LC / MS/MS). (c) A confirmatory test must be validated before it can be used to test specimens. 11.13 What must a laboratory do to validate a confirmatory test method To validate a confirmatory test, the laboratory must demonstrate: (1) The linear range of the analysis; (2) The limit of detection; (3) The limit of quantitation; (4) The accuracy and precision at the cutoff concentration; (5) The accuracy and precision at 40 percent of the cutoff concentration; and (6) The potential for interfering substances.

11.14 Why must the confirmatory test be calibrated The confirmatory test must be calibrated to ensure and document the linearity of the assay method over time in the concentration area of the cutoff. 11.15 What are the quality control requirements when conducting a confirmatory test (a) Each batch of specimens must contain the following types of QC samples: (1).