Common use of Laboratory Procedures Clause in Contracts

Laboratory Procedures. Drug testing laboratories shall be secure at all times and shall have in place sufficient security measures to control access to the premises and to ensure no unauthorized personnel handle the specimens or gain access to the laboratory process or areas where records are stored in accordance with SAMHSA requirements. Laboratories shall use chain of custody procedures to maintain control and accountability of specimens from receipt through completion of testing, reporting of results during storage, and continuing until final disposition of specimens. The date and purpose shall be documented on an appropriate chain of custody form each time a specimen is handled or transferred and every individual in the chain shall be identified. The initial test shall use an immunoassay which meets the requirements of the Food and Drug Administration for commercial distribution. Cutoff levels shall be those in effect by ▇▇▇▇▇▇ at the time the specimen is tested and may change from time to time as determined by ▇▇▇▇▇▇. All specimens identified as positive on the initial test shall be confirmed using gas chromatography/mass spectrometry (GC/MS) techniques at the cutoff levels then in effect by SAMHSA. All confirmations shall be by quantitative analysis. The laboratory shall report test results to the Medical Review Officer (MRO) within an average of 5 working days after receipt of the specimen by the laboratory. Before any test result is reported (the results of initial tests, confirmatory tests, or quality control data), it shall be reviewed and the test certified as an accurate report by the responsible individual. The report shall identify the drugs/metabolites tested for, whether positive or negative and the chain of custody control number. The laboratory shall report as negative all specimens that are negative on the initial test or negative on the confirmatory test. Only specimens confirmed positive shall be reported positive for a specific drug. The MRO may request from the laboratory and the laboratory shall provide quantification of test results. The MRO shall report whether the test is positive or negative to the Personnel Department and may report the drug(s) for which there was a positive test. The laboratory shall send only to the MRO the original or a certified true copy of the drug testing custody and control form, which, in the case of a report positive for drug use, shall be signed (after the required certification block) by the individual responsible for day-to-day management of the drug testing laboratory or the individual responsible for attesting to the validity of the test reports, and attached to which shall be a copy of the test report. Unless otherwise instructed by the City in writing, all records pertaining to a given urine specimen shall be retained by the drug testing laboratory for a minimum of 2 years. The laboratory shall retain and place in properly secured long term frozen storage for a minimum of 1 year all specimens confirmed positive, in their original labeled specimen bottles. Within this 1 year period, the City may request the laboratory to retain the specimen for an additional period of time, but if no such request is received the laboratory may discard the specimen after the end of 1 year, except that the laboratory shall be required to maintain any specimens known to be under legal challenge for an indefinite period. Because some analytes deteriorate or are lost during freezing and/or storage, quantification for a retest is not subject to a specific cutoff requirement but must provide data sufficient to confirm the presence of the drug or metabolite. The drug testing laboratory shall maintain and make available for at least 2 years documentation of all aspects of the testing process. This 2 year period may be extended upon written notification by the Office of Internal Investigation. The required documentation shall include personnel files on all individuals authorized to have access to specimens; chain of custody documents; quality assurance/quality control records; procedure manuals; all test data (including calibration curves and any calculations used in determining test results); reports; performance records on performance testing; performance on certification inspections; and hard copies of computer-generated data. The laboratory shall maintain documents for any specimen known to be under legal challenge for an indefinite period.

Laboratory Procedures. a. Drug testing laboratories shall be secure secured at all times and shall have in place sufficient security measures to control access to the premises and to ensure that no unauthorized personnel handle the specimens or gain access to the laboratory process or areas have access to where records are stored in accordance with SAMHSA requirements. stored. b. Laboratories shall use chain of custody procedures to maintain control and accountability of specimens from receipt through completion of testing, reporting of results during storage, and continuing until final disposition of specimens. The date and purpose shall be documented on an appropriate chain Chain of custody form Custody Form each time a specimen is handled or transferred and every individual in the chain shall be identified. The initial test shall use an immunoassay which meets the requirements of the Food and Drug Administration for commercial distribution. Cutoff levels Accordingly, authorized technicians shall be responsible for each urine specimen or aliquot in their possession and shall sign and complete Chain of Custody Forms for those in effect by ▇▇▇▇▇▇ at specimens or aliquots as they are received. (1) When a shipment of specimens is received, laboratory personnel shall inspect each package for evidence of possible tampering and compare information on specimen bottles within each package to the time the specimen is tested and may change from time to time as determined by ▇▇▇▇▇▇. All specimens identified as positive information on the initial test accompanying Chain of Custody Forms. Any direct evidence of tampering or discrepancies in the information on specimen bottles and the Department’s Chain of Custody Forms attached to the shipment shall be confirmed using gas chromatographyimmediately reported to the Department Head or his/mass spectrometry (GC/MS) techniques at the cutoff levels then in effect by SAMHSA. All confirmations her designee and shall be by quantitative analysis. The laboratory shall report test results to the Medical Review Officer (MRO) within an average of 5 working days after receipt of the specimen by noted on the laboratory. Before any test result is reported (’s Chain of Custody Form which shall accompany the results of initial tests, confirmatory tests, or quality control data), it shall be reviewed and the test certified as an accurate report by the responsible individual. The report shall identify the drugs/metabolites tested for, whether positive or negative and the chain of custody control number. The laboratory shall report as negative all specimens that while they are negative on the initial test or negative on the confirmatory test. Only specimens confirmed positive shall be reported positive for a specific drug. The MRO may request from the laboratory and the laboratory shall provide quantification of test results. The MRO shall report whether the test is positive or negative to the Personnel Department and may report the drug(s) for which there was a positive test. The laboratory shall send only to the MRO the original or a certified true copy of the drug testing custody and control form, which, in the case of a report positive for drug use, shall be signed laboratory’s possession. (after the required certification block2) by the individual responsible for day-to-day management of the drug testing laboratory or the individual responsible for attesting to the validity of the test reports, and attached to which shall be a copy of the test report. Unless otherwise instructed by the City in writing, all records pertaining to a given urine specimen Specimen bottles generally shall be retained within the laboratory’s accession area until all analyses have been completed. Aliquots and the laboratory’s Chain of Custody Forms shall be used by the drug testing laboratory personnel for a minimum conducting initial and confirmatory tests. d. Specimens that do not receive an initial test within seven (7) days of 2 years. The laboratory shall retain and place in properly secured long term frozen storage for a minimum of 1 year all specimens confirmed positive, in their original labeled specimen bottles. Within this 1 year period, the City may request the laboratory to retain the specimen for an additional period of time, but if no such request is received the laboratory may discard the specimen after the end of 1 year, except that arrival at the laboratory shall be required to maintain any specimens known to be under legal challenge for an indefinite periodplaced in secure refrigeration units. Because some analytes deteriorate or are lost during freezing and/or storage, quantification for a retest is Temperatures shall not subject to a specific cutoff requirement but must provide data sufficient to confirm the presence of the drug or metabolite. The drug testing laboratory shall maintain and make available for at least 2 years documentation of all aspects of the testing process. This 2 year period may be extended upon written notification by the Office of Internal Investigation. The required documentation shall include personnel files on all individuals authorized to have access to specimens; chain of custody documents; quality assurance/quality control records; procedure manuals; all test data (including calibration curves and any calculations used in determining test results); reports; performance records on performance testing; performance on certification inspections; and hard copies of computer-generated data. The laboratory shall maintain documents for any specimen known to be under legal challenge for an indefinite period.exceed six

Laboratory Procedures. a. Drug testing laboratories shall be secure secured at all times and shall have in place sufficient security measures to control access to the premises and to ensure that no unauthorized personnel handle the specimens or gain access to the laboratory process or areas have access to where records are stored in accordance with SAMHSA requirements. stored. b. Laboratories shall use chain of custody procedures to maintain control and accountability of specimens from receipt through completion of testing, reporting of results during storage, and continuing until final disposition of specimens. The date and purpose shall be documented on an appropriate chain Chain of custody form Custody Form each time a specimen is handled or transferred and every individual in the chain shall be identifiedidenti fied. Accordingly, authorized technicians shall be responsible for each urine specimen or aliquot in their possession and shall sign and complete Chain of Custody Forms for those specimens or aliquots as they are received. (1) When a shipment of specimens is received, laboratory personnel shall inspect each package for evidence of possible tampering and compare information on specimen bottles within each package to the information on the accompanying Chain of Custody Forms. Any direct evidence of tampering or discrepancies in the information on specimen bottles and the Department's Chain of Custody Forms attached to the shipment shall be immediately reported to the Colonel and shall be noted on the laboratory's Chain of Custody Form which shall accompany the specimens while they are in the laboratory's possession. (2) Specimen bottles generally shall be retained within the laboratory's accession area until all analyses have been completed. Aliquots and the laboratory's Chain of Custody Forms shall be used by laboratory personnel for conducting initial and confirmatory tests. d. Specimens that do not receive an initial test within seven (7) days of arrival at the laboratory shall be placed in secure refrigeration units. Temperatures shall not exceed s ix (6) degrees Celsius. Emergency power equipment shall be available in case of prolonged power failure. e. Laboratory facilities for urine drug testing will normally process specimens by grouping them into batches. When conducting either initial or con firmatory tests, every batch shall contain an appropriate number of standards for calibrating the instrumentation and a minimum of ten percent (10%) controls. Both quality control and blind performance test samples shall appear as ordinary samples to laboratory analysts. (1) The initial test shall use an immunoassay which meets the requirements of the Food and Drug Administration for commercial distribution. Cutoff The following initial cutoff levels shall be those in effect by ▇▇▇▇▇▇ at the time the specimen is tested and may change from time used when screening specimens to time as determined by ▇▇▇▇▇▇. All specimens identified as positive on the initial test shall be confirmed using gas chromatography/mass spectrometry (GC/MS) techniques at the cutoff levels then in effect by SAMHSA. All confirmations shall be by quantitative analysis. The laboratory shall report test results to the Medical Review Officer (MRO) within an average of 5 working days after receipt of the specimen by the laboratory. Before any test result is reported (the results of initial tests, confirmatory tests, or quality control data), it shall be reviewed and the test certified as an accurate report by the responsible individual. The report shall identify the drugs/metabolites tested for, whether positive or negative and the chain of custody control number. The laboratory shall report as negative all specimens that determine whethe r they are negative on the initial test for these five drugs or negative on the confirmatory test. Only specimens confirmed positive shall be reported positive for a specific drug. The MRO may request from the laboratory and the laboratory shall provide quantification classes of test results. The MRO shall report whether the test is positive or negative to the Personnel Department and may report the drug(s) for which there was a positive test. The laboratory shall send only to the MRO the original or a certified true copy of the drug testing custody and control form, which, in the case of a report positive for drug use, shall be signed drugs: Initial Test Cutoff Levels (after the required certification block) by the individual responsible for day-to-day management of the drug testing laboratory or the individual responsible for attesting to the validity of the test reports, and attached to which shall be a copy of the test report. Unless otherwise instructed by the City in writing, all records pertaining to a given urine specimen shall be retained by the drug testing laboratory for a minimum of 2 years. The laboratory shall retain and place in properly secured long term frozen storage for a minimum of 1 year all specimens confirmed positive, in their original labeled specimen bottles. Within this 1 year period, the City may request the laboratory to retain the specimen for an additional period of time, but if no such request is received the laboratory may discard the specimen after the end of 1 year, except that the laboratory shall be required to maintain any specimens known to be under legal challenge for an indefinite period. Because some analytes deteriorate or are lost during freezing and/or storage, quantification for a retest is not subject to a specific cutoff requirement but must provide data sufficient to confirm the presence of the drug or metabolite. The drug testing laboratory shall maintain and make available for at least 2 years documentation of all aspects of the testing process. This 2 year period may be extended upon written notification by the Office of Internal Investigation. The required documentation shall include personnel files on all individuals authorized to have access to specimens; chain of custody documents; quality assuranceng/quality control records; procedure manuals; all test data (including calibration curves and any calculations used in determining test results); reports; performance records on performance testing; performance on certification inspections; and hard copies of computer-generated data. The laboratory shall maintain documents for any specimen known to be under legal challenge for an indefinite period.ml)3 Marijuana metabolites 100 Cocaine metabolites 300 Opiates metabolites 3004 Phencyclidine 25 Amphetamines 1000 3 ng = nanograms ml = milliliters

Laboratory Procedures. a. Drug testing laboratories shall be secure secured at all times and shall have in place sufficient security measures to control access to the premises and to ensure that no unauthorized personnel handle the specimens or gain access to the laboratory process or areas have access to where records are stored in accordance with SAMHSA requirements. stored. b. Laboratories shall use chain of custody procedures to maintain control and accountability of specimens from receipt through completion of testing, reporting of results during storage, and continuing until final disposition of specimens. The date and purpose shall be documented on an appropriate chain Chain of custody form Custody Form each time a specimen is handled or transferred and every individual in the chain shall be identified. Accordingly, authorized technicians shall be responsible for each urine specimen or aliquot in their possession and shall sign and complete Chain of Custody Forms for those specimens or aliquots as they are received. (1) When a shipment of specimens is received, laboratory personnel shall inspect each package for evidence of possible tampering and compare information on specimen bottles within each package to the information on the accompanying Chain of Custody Forms. Any direct evidence of tampering or discrepancies in the information on specimen bottles and the Department’s Chain of Custody Forms attached to the shipment shall be immediately reported to the Department Head or his/her designee and shall be noted on the laboratory’s Chain of Custody Form which shall accompany the specimens while they are in the laboratory’s possession. (2) Specimen bottles generally shall be retained within the laboratory’s accession area until all analyses have been completed. Aliquots and the laboratory’s Chain of Custody Forms shall be used by laboratory personnel for conducting initial and confirmatory tests. d. Specimens that do not receive an initial test within seven (7) days of arrival at the laboratory shall be placed in secure refrigeration units. Temperatures shall not exceed six (6) degrees Celsius. Emergency power equipment shall be available in case of prolonged power failure. e. Laboratory facilities for urine drug testing will normally process specimens by grouping them into batches. When conducting either initial or confirmatory tests, every batch shall contain an appropriate number of standards for calibrating the instrumentation and a minimum of ten percent (10%) controls. Both quality control and blind performance test samples shall appear as ordinary samples to laboratory analysts. (1) The initial test shall use an immunoassay which meets the requirements of the Food and Drug Administration for commercial distribution. Cutoff The following initial cutoff levels shall be used when screening specimens to determine whether they are negative for these five drugs or classes of drugs: Marijuana metabolites 100 Cocaine metabolites 300 Opiates metabolites 3004 Phencyclidine 25 Amphetamines 1000 (2) These cutoff levels are subject to change by the DHHS as advances in technology or other considerations warrant identification of these substances at other concentrations. For drugs not listed in (f)(1) above, cutoff levels to be used shall, when available, be those in effect then specified by ▇▇▇▇▇▇ at the time the specimen is tested and may change from time to time as determined by ▇▇▇▇▇▇. DHHS. (1) All specimens identified as positive on the initial test shall be confirmed using gas chromatography/mass spectrometry (GC/MS) techniques at the cutoff levels then listed in effect by SAMHSAthis paragraph for each drug. All confirmations shall be by quantitative analysis. Marijuana metabolite5 15 Cocaine metabolite6 150 Opiates Morphine 300 Codeine 300 Phencyclidine 25 Amphetamines Amphetamine 500 Methamphetamines 500 (2) These cutoff levels are subject to change by the DHHS as advances in technology or other considerations warrant identification of these substances at other concentrations. For drugs not listed in (g)(1) above, cutoff levels to be used shall, when available, be those then specified by the DHHS. (1) The laboratory shall report test results to the Medical Review Officer (MRO) MRO within an average of 5 five (5) working days after receipt of the specimen by the laboratory. Before any test result is reported (the results of initial tests, confirmatory tests, or quality control data), it shall be reviewed and the test certified as an accurate report by the responsible individual. The report shall identify the drugs/metabolites tested for, whether positive or negative and the chain of custody control number. The laboratory shall report as negative all specimens that are negative on the initial test or negative on the confirmatory test. Only specimens confirmed positive shall be reported positive for a specific drug. The MRO may request from the laboratory and the laboratory shall provide quantification of test results. The MRO shall report whether the test is positive or negative to the Personnel Department and may report the drug(s) for which there was a positive test. The laboratory shall send only to the MRO the original or a certified true copy of the drug testing custody and control form, which, in the case of a report positive for drug use, shall be signed (after the required certification block) by the individual responsible for day-to-day management of the drug testing laboratory or the individual responsible for attesting to the validity of the test reports, and attached to which shall be a copy of the test report. Unless otherwise instructed by the City in writing, all records pertaining to a given urine specimen shall be retained by the drug testing laboratory for a minimum of 2 years. The laboratory shall retain and place in properly secured long term frozen storage for a minimum of 1 year all specimens confirmed positive, in their original labeled specimen bottles. Within this 1 year period, the City may request the laboratory to retain the specimen for an additional period of time, but if no such request is received the laboratory may discard the specimen after the end of 1 year, except that the laboratory shall be required to maintain any specimens known to be under legal challenge for an indefinite period. Because some analytes deteriorate or are lost during freezing and/or storage, quantification for a retest is not subject to a specific cutoff requirement but must provide data sufficient to confirm the presence of the drug or metabolite. The drug testing laboratory shall maintain and make available for at least 2 years documentation of all aspects of the testing process. This 2 year period may be extended upon written notification by the Office of Internal Investigation. The required documentation shall include personnel files on all individuals authorized to have access to specimens; chain of custody documents; quality assurance/quality control records; procedure manuals; all test data (including calibration curves and any calculations used in determining test results); reports; performance records on performance testing; performance on certification inspections; and hard copies of computer-generated data. The laboratory shall maintain documents for any specimen known to be under legal challenge for an indefinite period.The