NOTE: Free essay sample provided on this page should be used for references or sample purposes only. The sample essay is available to anyone, so any direct quoting without mentioning the source will be considered plagiarism by schools, colleges and universities that use plagiarism detection software. To get a completely brand-new, plagiarism-free essay, please use our essay writing service.
One click instant price quote
... 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 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: (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: (b) Correctly identify and confirm 90 percent of the total drug challenges on the 3 sets of samples; (c) The quantitative values for at least 80 percent of the total drug challenges must be within 20 percent of the calculated reference group mean; (d) No quantitative value on a drug concentration may differ by more than 50 percent from the calculated reference group mean; and (e) For an individual drug, correctly detect and quantify at least 50 percent of the total drug challenges. 9. 5 What are the performance testing requirements for a certified laboratory? A certified laboratory must satisfy the following criteria on the maintenance PT samples to maintain its certification: (a) Correctly identify and confirm 90 percent of the total drug challenges over two consecutive PT cycles; (b) Correctly quantify 80 percent of the total drug challenges within 20 percent of the appropriate reference or peer group mean as measured over two consecutive PT cycles; (c) Have no more than one quantitative result differ more than 50 percent from the target value over two consecutive PT cycles; and (d) For any individual drug, correctly detect and quantify at least 50 percent of the total drug challenges. 9. 6 What are the inspection requirements for an applicant laboratory? (a) An applicant laboratory is inspected by a team of at least two inspectors. (b) Each inspector conducts an independent evaluation and review of all aspects of the laboratory's procedures and facilities using the guidance provided by the Secretary and the National Laboratory Certification Program inspection checklist. (c) To become certified, an applicant laboratory must satisfy the minimum requirements as stated in these Guidelines. 9. 7 What are the inspection requirements for a certified laboratory? (a) It must undergo an inspection 3 months after becoming certified and then inspected semiannually thereafter. (b) A certified laboratory is inspected by a team of at least two inspectors. The number of inspectors required is dependent on the workload of the laboratory. (c) Each inspector conducts an independent evaluation and review of all aspects of the laboratory's procedures and facilities using the guidance provided by the Secretary and the National Laboratory Certification Program inspection checklist. (d) To remain certified, a laboratory must continue to satisfy the minimum requirements as stated in these Guidelines. 9. 8 Who may inspect a laboratory participating in the NLCP? (a) The Secretary, a Federal agency using a certified laboratory, or the contractor awarded the HHS NLCP contract may inspect a laboratory at any time. (b) An individual may serve as an NLCP inspector if he or she satisfies the following criteria: (1) Has experience and an educational background similar to that required for either the responsible person or the certifying scientist as described in subpart K; (2) Has read and thoroughly understands the policies and requirements contained in these Guidelines and in other NLCP documents; (3) Submits a resume and documentation of qualifications to HHS; (4) Attends NLCP approved training; and (5) Submits an acceptable inspection report and has acceptable performance as a trainee on an inspection. 9. 9 What happens if a laboratory does not satisfy the minimum requirements for either the PT program or the inspection program? (a) If an applicant laboratory fails to satisfy the requirements established for the initial certification process, the applicant laboratory must start the initial certification process from the beginning. (b) If a certified laboratory fails to satisfy the minimum requirements, the laboratory is given a period of time (e.
g. , 5 or 30 working days depending on the nature of the issue) to provide any explanation for its performance and evidence that any deficiency has been corrected. (c) A laboratory's certification may be revoked, suspended, or no further action taken depending on the seriousness of the errors and whether there is evidence that any deficiency has been corrected and that current performance meets the requirements for a certified laboratory. (d) A certified laboratory may be required to undergo a special inspection or to test additional PT samples, depending on the nature of the performance, to verify that any deficiency has been corrected. (e) If a laboratory's certification is revoked or suspended, the laboratory is not permitted to test specimens for Federal agencies or federally regulated employers until the suspension is lifted or the laboratory has successfully completed the certification requirements as a new applicant laboratory. 9. 10 Where is a list of certified laboratories published? (a) A list of HHS certified laboratories is published monthly in the Federal Register. (b) Applicant laboratories are not included in the list. Subpart J - Blind Samples Submitted by an Agency 10. 1 What are the requirements for a blind sample? (a) A blind sample must be validated as to its content by the supplier using initial and confirmatory tests. (b) The supplier must provide information regarding the shelf life of the blind sample. (c) If the blind sample is positive, the concentration of the drug it contains must be at least 25 percent above the cutoff concentration for that drug. 10. 2 What are the requirements for Federal agencies to submit blind samples? (a) Each Federal agency is required to have both negative and positive blind samples submitted with its donor specimens. (b) During the initial 90 -day period of any new Federal agency drug testing program, the agency must ensure that at least 5 percent of the total number of donor specimens submitted are blind samples. (c) After the initial 90 -day period, the Federal agency must ensure that a minimum of 3 percent of the total number of donor specimens are blind samples. (d) Approximately 80 percent of the blind samples may be negative (i. e. , certified to contain no drug) and the remaining positive for one or more drugs. (e) Each positive sample must be spiked only with those drugs for which the Federal agency is testing. 10. 3 How is a blind sample submitted to the laboratory? (a) A blind sample is either purchased by the Federal agency and given to the collector or the collector purchases the blind sample from a supplier and submits the blind sample with the Federal agency's donor specimens. (b) A blind sample is always submitted using the same CCF as used for a donor specimen. The collector provides the required information to ensure that the CCF has been properly completed as well as providing fictitious initials on the specimen bottle label / seal . Since there is no donor, the collector must indicate that the sample is a "blind sample" on the MRO copy where the donor would normally provide a signature. (c) Each Federal agency must ensure that the required blind samples are distributed throughout the total number of donor specimens rather than submitted as a single group of samples. 10. 4 What happens if an inconsistent result is reported on a blind sample?
The Medical Review Officer (MRO) is generally the individual who finds that a laboratory has reported an inconsistent result on a blind sample. When such a result is identified: (a) The MRO must notify both the Federal agency and the Federal office responsible for maintaining the NLCP; and (b) The Federal office responsible for the NLCP will initiate an investigation to determine the cause of the error and send a report to the MRO and the Federal agency describing the investigation and corrective action taken. 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: (4) Quality control / quality assurance programs; (5) Analytical methods and procedures; (6) Equipment and maintenance programs; (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 laboratory's 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. (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. (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; (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) 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 at 25 percent above the cutoff concentration; (4) At least one control that has the concentration of the drug or metabolite at 40 percent of the cutoff concentration; and (5) At least one control in every batch must be blind. (b) The linear range, limit of detection, and limit of quantitation must be documented and periodically re-evaluated for each confirmatory test. (c) A laboratory must establish a procedure to ensure that any carryover that might occur between aliquots in the confirmatory batch is detectable and corrected. 11. 16 Is a laboratory allowed to conduct any additional tests on a specimen? (a) A laboratory is permitted to conduct additional tests to determine the validity of a specimen. (b) The validity tests that may be used will depend on the type of specimen being tested. (c) Specific guidance on conducting validity tests is described in NLCP program documents. (d) No further testing of a negative specimen for drugs is permitted and the specimen must either be discarded or pooled for use in the laboratory's internal quality control program. 11. 17 What are the requirements for a laboratory to report the test result for a specimen? (a) The laboratory must report the test result within 5 (on average) working days after receipt of the specimen. (b) A specimen identified as positive for a drug or metabolite on an initial test must be confirmed positive before a positive result can be reported to the MRO. (c) The laboratory may report only that a specimen is positive without including the concentration of the drug unless the MRO specifically requests the concentration. (d) The laboratory can only report a test result to an MRO. (e) The laboratory may transmit results to the MRO by various electronic means (e. g. , facsimile, computer) in a manner designed to ensure the confidentiality of the information, the security of the data transmission, and limit access to any data transmission, storage, and retrieval system. (f) A hard copy of the CCF must be sent to the MRO when the result is reported as either positive for a specific drug, adulterated, substituted, rejected for testing, or invalid result. (g) A facsimile or electronic report is sufficient to report a negative result. (h) A test result may not be provided telephonically; however, the MRO may call the laboratory to discuss a result. (i) The laboratory may also send the MRO a separate laboratory report that gives additional information (e.
g. , cutoffs) for the specimen tested. (j) A laboratory must use its own form to report the results for the retesting of a single specimen. 11. 18 How long must a laboratory retain a specimen? (a) A laboratory must retain a specimen that was reported either positive, adulterated, substituted, diluted, rejected for testing, 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. 11. 19 How long must a laboratory retain records? (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. 11. 20 Can a laboratory store records electronically? 11. 21 What summary report must a laboratory provide to a Federal agency? (a) A laboratory must provide a semi-annual summary report to a Federal agency for which it tests specimens, but must not include any personal identifying information for the specimens tested. (b) The summary report must contain the following information: (1) Total number of specimens reported (2) Number of specimens grouped by reason for test (3) Number of specimens rejected for testing NOTE: We are currently evaluating the need for this report. 11. 22 What information is available to the donor? (a) A Federal employee who is the subject of a drug test 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 donors specimen and associated quality control samples, chain of custody records, and other administrative documents generated during the handling and testing of the donors specimen that support the test result reported by the laboratory. 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? When a certified laboratory uses procedures that are different from those for which it is certified to test private sector client specimens, it must inform the private sector client that its specimens are not being tested under the Guidelines and are not subject to review by the NLCP. Subpart L - Point of Collection Test (POCT) 12. 1 What is a Point of Collection Test?
A point of collection test (POCT) is an initial test conducted at the collection site for either the presence of drugs or to determine specimen validity. 12. 2 What types of POCT devices are there? (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 endpoint result is obtained by instrumental evaluation (e. g. , densitometer, spectrophotometer). 12. 3 What are the requirements for a POCT device? (a) The POCT device must be cleared by the FDA. (b) Validation studies must be completed prior to placing a new lot in service. (c) The POCT device must be included on the SAMHSA/HHS Conforming Products List. (a) A certified collector must collect the specimen. The specimen may be transferred under chain of custody if the specimen is going to be tested by another individual. (b) A trained tester under the supervision of a Responsible Technician must perform the test. 12. 5 What are the qualifications for the person who performs a POCT? (a) The person who performs the POCT must be a certified collector. (b) Additionally, this person must be trained in the use of the specific device / system used to perform the POCT. (c) This training must be documented in the testers personnel file. 12. 6 What are the responsibilities of a Responsible Technician? The Responsible Technician (RT) must fulfill the following responsibilities: (a) Manage the day-to-day operations of the POCT facility 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 conduct the work of the POCT facility. 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
Free research essays on topics related to: laboratory, federal agency, testing, workplace drug testing, specimen
Research essay sample on Workplace Drug Testing Federal Agency
