Drug Laws Essay, Research Paper
Note: This bill of exchange papers represents a joint attempt by the SAMHSA/CSAP Division of Workplace Programs and members of the SAMHSA Drug Testing Advisory Board ( DTAB ) . It has non been reviewed by all members of the DTAB, by industry working groups, or by other Federal bureaus. This bill of exchange papers is the first release to a wider audience. It will function as the footing for developing the guidelines for Federal Workplace Drug Testing Programs.
All interested parties are invited to notice on the bill of exchange papers. Remarks may be mailed to the Division of Workplace Programs, 5600 Fishers Lane, Rockwall II, Suite 815, Rockville, Maryland 20857, by facsimile ( 301-443-3031 ) , or by electronic mail: wvogl @ samhsa.gov *mailto: wvogl @ samhsa.gov* or clodico @ samhsa.gov *mailto: clodico @ samhsa.gov*
Please subject your remarks by July 12, 2000, to guarantee they are considered prior to the September Drug Testing Advisory Board meeting.
MANDATORY GUIDELINES
for
FEDERAL WORKPLACE DRUG TESTING PROGRAMS
Subpart A & # 8211 ; Applicability
Sec.
1.1 Whom do these Guidelines screen?
1.2 Who is responsible for developing and publishing important readings of the Guidelines?
1.3 How is an freedom granted from these Guidelines?
1.4 How are these Guidelines revised?
1.5 What do the footings used in these Guidelines mean?
Subpart B & # 8211 ; Specimens
2.1 What types of specimens may be collected?
2.2 Under what fortunes can the different types of specimens be collected?
Subpart C & # 8211 ; 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 intents?
3.4 What is the cutoff concentration for each drug by type of specimen collected?
Subpart D & # 8211 ; Collectors
4.1 Who may roll up a specimen?
4.2 What preparation and enfranchisement must a aggregator hold?
4.3 Who can develop and attest a aggregator?
4.4 Under what fortunes must a aggregator be retrained?
4.5 What are the aggregator monitoring and support demands for organisations using aggregators?
Subpart E & # 8211 ; Collection Sites
5.1 Where can a aggregation for a drug trial take topographic point?
5.2 What are the demands for a aggregation site?
5.3 How long must collection site records be stored?
5.4 How does the aggregator guarantee the security of a specimen at the aggregation site?
5.5 What are the privateness considerations when roll uping a specimen?
5.6 What supplies are needed at the aggregation site?
5.7 How make you protect the privateness of a giver at the aggregation site?
Subpart F & # 8211 ; Federal Drug Testing Custody and Control Forms
6.1 What signifier is used to document roll uping a specimen?
6.2 What happens if an sanctioned signifier is non available or is non used?
Subpart G & # 8211 ; Collection Device
7.1 What is a aggregation device?
7.2 Must the aggregation device be cleared by the FDA?
Subpart H & # 8211 ; Specimen Collection Procedure
8.1 What must the aggregator do before get downing the aggregation process?
8.2 What are the basic demands for roll uping any type of specimen?
8.3 Where can I happen the aggregation process for each type of specimen?
Subpart I & # 8211 ; National Laboratory Certification Program
9.1 What is the National Laboratory Certification Program ( NLCP ) ?
9.2 How does a research lab apply to the NLCP?
9.3 What is a public presentation testing ( PT ) sample?
9.4 What are the public presentation testing demands for an applicant research lab?
9.5 What are the public presentation testing demands for a certified research lab?
9.6 What are the review demands for an applicant research lab?
9.7 What are the review demands for a certified research lab?
9.8 Who may inspect a research lab take parting in the NLCP?
9.9 What happens if a research lab does non fulfill the lower limit demands for either the PT plan or the review plan?
9.10 Where is a list of certified research labs published?
Subpart J & # 8211 ; Blind Samples Submitted by an Agency
10.1 What are the demands for a unsighted sample?
10.2 What are the demands for Federal bureaus to subject blind samples?
10.3 How is a unsighted sample submitted to the research lab?
10.4 What happens if an inconsistent consequence is reported on a unsighted sample?
Subpart K & # 8211 ; Laboratory Requirements
11.1 What is a Standard Operating Procedure Manual?
11.2 What makings must the research lab? s responsible individual ( RP ) have?
11.3 What are the duties of the RP?
11.4 What makings and preparation must an person have to attest a drug trial consequence that is reported by a research lab?
11.5 What makings and preparation must other research lab forces have?
11.6 What security measures must a research lab maintain?
11.7 How must a research lab grip a specimen or an aliquot?
11.8 What is an initial trial?
11.9 What must a research lab bash to formalize an initial trial method?
11.10 Why must the initial trial be calibrated?
11.11 What are the quality control demands when carry oning an initial trial?
11.12 What is a collateral trial?
11.13 What must a research lab bash to formalize a collateral trial method?
11.14 Why must the collateral trial be calibrated?
11.15 What are the quality control demands when carry oning a confirmatory trial?
11.16 Is a research lab allowed to carry on any extra trials on a specimen?
11.17 What are the demands for a research lab to describe the trial consequence for a specimen?
11.18 How long must a research lab retain a specimen?
11.19 How long must a research lab retain records?
11.20 Can a laboratory shop records electronically?
11.21 What drumhead study must a research lab provide to a Federal bureau?
11.22 What information is available to the giver?
11.23 What type of relationship is prohibited between a research lab and an MRO?
11.24 What information must a certified research lab provide to its private sector clients?
Subpart L & # 8211 ; Point of Collection Test ( POCT )
12.1 What is a point of aggregation trial?
12.2 What types of POCT devices are at that place?
12.3 What are the demands for a POCT device?
12.4 Who may carry on a POCT?
12.5 What are the makings for the individual who performs a POCT?
12.6 What are the duties of a responsible technician?
12.7 Which specimen types may be tested utilizing a POCT?
12.8 What are the cutoff concentrations when utilizing a POCT?
12.9 May the giver observe the POCT being performed?
12.10 What are the demands for carry oning a POCT?
12.11 What are the quality control demands when carry oning a POCT?
12.12 What are the application demands for a POCT supplier?
12.13 What are the qualitative and quantitative specifications for PT samples that are used to measure a POCT supplier?
12.14 What are the review demands for a POCT supplier?
12.15 Who may inspect a POCT supplier?
12.16 What happens if a POCT supplier does non fulfill the minimal review demands?
12.17 Where is a list of & # 8220 ; recognized & # 8221 ; POCT suppliers published?
12.18 Is a POCT supplier allowed to carry on any extra trials on a specimen?
12.19 How long must a POCT supplier retain a specimen?
12.20 How long must a POCT supplier retain records?
12.21 Can a POCT supplier shop records electronically?
12.22 What drumhead study must a Federal bureau receive from a POCT supplier?
12.23 What type of relationship is prohibited between a POCT supplier and a Medical Review Officer?
12.24 What type of relationship can be between a POCT supplier and an HHS certified research lab?
12.25 What security measures must a POCT supplier maintain?
12.26 What information is available to the giver?
12.27 What is the minimal specimen volume for a POCT?
12.28 What action may a Federal bureau take when a POCT is positive?
12.29 How is the POCT consequence reported to the Medical Review Officer?
Subpart M -Instrumented Initial Test Facility
13.1 What is an instrumented initial trial installation?
13.2 Are research labs that perform merely initial trials allowed?
13.3 What is an instrumented initial trial?
13.4 What types of initial trials are at that place?
13.5 What are the demands for an instrumented initial trial installation?
13.6 Why must the instrumented initial trial device be calibrated?
13.7 Who may carry on an instrumented initial trial?
13.8 What are the makings for the individual who performs an instrumented initial trial?
13.9 What are the duties of a responsible technician?
13.10 Which specimen types may be tested utilizing an instrumented initial trial?
13.11 What are the cutoff concentrations when utilizing an instrumented initial trial?
13.12 What are the quality control demands when carry oning an instrumented initial trial?
13.13 What are the application demands for an instrumented initial trial installation?
13.14 What are the qualitative and quantitative specifications for PT samples that are used to measure an instrumented initial trial installation?
13.15 What are the review demands for an instrumented initial trial installation?
13.16 Who may inspect an instrumented initial trial installation?
13.17 What happens if an instrumented initial trial installation does non fulfill the minimal review demands?
13.18 Where is a list of & # 8220 ; recognized & # 8221 ; instrumented initial trial installations published?
13.19 Is an instrumented initial trial installation allowed to carry on any extra trials on a specimen?
13.20 How long must an instrumented initial trial installation retain a specimen?
13.21 How long must an instrumented initial trial installation retain records?
13.22 Can an instrumented initial trial installation shop records electronically?
13.23 What drumhead study must a Federal bureau receive from an instrumented initial trial installation?
13.24 What type of relationship is prohibited between an instrumented initial trial installation and a Medical Review Officer?
13.25 What type of relationship can be between an instrumented initial trial installation and an HHS certified research lab?
13.26 What security measures must an instrumented initial trial installation maintain?
13.27 What is the minimal specimen volume collected for an instrumented initial trial?
13.28 What action may a Federal bureau take when an instrumented initial trial is reported as a non-negative?
13.29 How is the instrumented initial trial consequence reported to the Medical Review Officer?
Subpart N & # 8211 ; Medical Review Officer ( MRO )
14.1 Who may function as an MRO?
14.2 What are the duties of an MRO?
14.3 What type of relationship is prohibited between an MRO and a research lab, POCT supplier, or an instrumented initial trial installation?
Subpart O & # 8211 ; Single Specimen Retests and Split Specimen Trials
15.1 When may a individual specimen or primary specimen be retested?
15.2 When may a split specimen be tested?
15.3 How does a research lab handle the retesting of a individual specimen or the testing of a split specimen?
15.4 Who receives the individual specimen retest consequence or the split specimen ensue?
15.5 What happens when a individual specimen retest or split specimen consequence does non reconfirm the original trial consequence?
15.6 How long must a research lab retain a split specimen?
Subpart P & # 8211 ; Problems with Drug Trials
16.1 What jobs will ever ensue in a research lab non proving a specimen?
16.2 What jobs will ensue in a research lab non describing a drug trial consequence unless the job is corrected?
Subpart Q & # 8211 ; Laboratory Suspension/Revocation Procedures
17.1 When may a certified research lab be suspended?
17.2 When may a research lab? s enfranchisement be revoked?
17.3 What is the process when a research lab is suspended?
17.4 What is the process when there is a proposal to revoke a research lab? s enfranchisement?
17.5 Where are notices of laboratory actions published?
Authority:
Subpart A & # 8211 ; Applicability
1.1 Whom do these Guidelines screen?
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 excepting the Armed Forces every bit defined in 5 U.S.C. 2101 ( 2 ) ) ;
( degree Celsius ) Any other using unit or authorization of the Federal Government except the United States Postal Service, the Postal Rate Commission, and using units or governments in the Judicial and Legislative Branches ; and
( vitamin D ) The Intelligence Community, as defined by Executive Order No. 12333, merely to the extent agreed to by the caput of the affected Agency.
1.2 Who is responsible for developing and publishing important readings of the Guidelines?
( a ) Executive Order 12564 and Public Law 100-71 require the Department of Health and Human Services ( HHS ) to set up 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 duty of providing:
( 1 ) The daily inadvertence of the Drug-Free Federal Workplace Program ; and
( 2 ) The development of comprehensive procedural and scientific criterions for all facets of a drug proving plan.
( degree Celsius ) The Division of Workplace Programs provides written readings of the commissariats in these Guidelines as written or electronic plan paperss, enchiridions, manuals, and Federal Register notices. These readings are the lone functionary and important readings that are valid and binding.
1.3 How is an freedom granted from these Guidelines?
( a ) A Federal bureau may non divert from the commissariats of these Guidelines without the written blessing of the Secretary of Health and Human Services.
( B ) In bespeaking blessing for a divergence, a Federal bureau must petition the Secretary in composing and depict the specific proviso or commissariats for which a divergence is sought and the principle for the divergence.
1.4 How are these Guidelines revised?
( a ) The Secretary of Health and Human Services is responsible for O.K.ing and printing in the Federal Register major alterations to these Guidelines. Examples of major alterations include, but are non limited to, alterations in cutoff concentrations, drugs tested, and scientific methods used.
( B ) The Division of Workplace Programs is responsible for doing minor alterations as a consequence of betterments in the available scientific discipline and engineering. These minor alterations are published as plan paperss or as Federal Register notices.
1.5 What do the footings used in these Guidelines mean?
The undermentioned definitions are adopted:
Aliquot A fractional portion of a specimen used for proving. It is taken as a sample stand foring the whole specimen.
Adulterated A specimen is considered to be adulterated if it either contains a substance that is non a normal component for that type of specimen or contains an endogenous substance at a concentration that is non 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 measure the ability of a research lab to prove a specimen for drugs and/or metabolites. The research lab does non cognize either the concentration of the drug or that it is a unsighted sample
Calibrator A solution of known concentration that is used to specify a measurement process or to compare the response obtained with the response of a trial specimen aliquot/sample. The concentration of the analyte of involvement in the calibrator is known within bounds ascertained during its readying. Calibrators may be used to set up a standardization curve over a scope of involvement.
Canceled trial The MRO determines that the consequence reported by the research lab or the POCT supplier can non back up describing either a positive nor a negative trial to the employer.
Attesting Scientist The person who is responsible for verifying the forensic and scientific supportability of a trial consequence.
Chain of Detention Procedures to account for the unity of each specimen or aliquot by tracking its handling and storage from point of specimen aggregation to concluding temperament of the specimen.
Chain of Custody Document The signifier ( s ) used by the research lab to document the security of the specimen and all aliquots of the specimens during proving and storage by the research lab. The signifier, which may account for an full trial batch, shall include the names and signatures of all persons who accessed the specimens or aliquots and the day of the month and intent of the entree.
Collection Site A topographic point where givers present themselves for the intent of supplying a specimen to be analyzed for the presence of drugs.
Collector A individual who instructs and assists givers at a aggregation site and receives the specimen provided by the giver.
Confirmatory Test An analytical process performed on a separate aliquot of the specimen to place the presence of a specific drug or metabolite.
Control A sample used to measure whether or non the analytical process is runing within predefined tolerance bounds.
Cut-off The concentration used to describe a specimen as negative or positive.
Dilute Refers to a specimen with less than normal components.
( TO BE DETERMINED FOR EACH SPECIMEN )
Donor The person from whom a specimen is collected.
Failed to Reconfirm The consequence reported when a research lab is unable to observe the drug or metabolite that was antecedently reported from the original analysis.
Federal Custody and Control Form An OMB approved signifier used to document the aggregation, security, and trial consequences of the specimen.
Follow-up Test A specimen collected from a giver to guarantee that the giver remains drug-free after being returned to a testing designated place.
HHS The Department of Health and Human Services or designee of the Secretary, Department of Health and Human Services.
Initial Test The trial used to distinguish a negative specimen from one that requires farther testing.
Invalid Result The consequence reported when a research lab is unable to obtain a scientifically bearable drug trial consequence.
HHS Certified Instrumented Initial Test Facility A location where initial testing, coverage of consequences, and recordkeeping is performed under the supervising of a responsible proficient ( RT ) .
HHS Certified Laboratory A location where initial and verification testing is performed under the supervising of an RP and Certifying Scientists are used for concluding reappraisal and release of drug proving consequences.
HHS Certified Point of Collection Test Facility A location where specimen aggregation, initial testing, coverage of consequences, and record maintaining is performed under the supervising of a responsible technician ( RT ) .
Medical Review Officer ( MRO ) A accredited doctor who receives, reappraisals, verifies, and reports the drug trial consequences.
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 category.
Non-Negative Result Result for a specimen from an initial trial that must travel to verification for a concluding study.
Positive Result Laboratory consequence for a specimen that contains a drug or metabolite greater than or equal to the cutoff concentration.
Post Accident Test A trial performed on a specimen collected from a giver after the giver is involved in a job-related accident.
Pre-employment Test A trial performed on a specimen collected from a giver who is using for a testing designated place.
Quality Control Sample A calibrator, control, and/or blind sample.
Random Test A trial performed on a specimen collected from a giver who is selected at random from the persons working in proving designated places.
Reasonable Suspicion/Cause Test ( TO BE DETERMINED )
Reconfirmed The consequence reported when a research lab is able to observe the drug or metabolite that was antecedently reported from the original analysis.
Rejected for Testing Result for a specimen for which the research lab or the point of aggregation trial device supplier does non execute any trials on the specimen.
Responsible Person ( RP ) The individual who assumes professional, organisational, educational, and administrative duty for the daily direction of the HHS certified research lab.
Responsible Technician ( RT ) The individual who assumes professional, organisational, educational, and administrative duty for the daily direction of the HHS certified
point of aggregation trial installation or the HHS certified instrumented initial trial installation.
Tax return to Duty Test A trial performed on a specimen collected from a giver prior to being reinstated in a testing designated place.
Sample A representative part of a specimen or quality control stuff used for proving.
Secretary The Secretary of Health and Human Services or the Secretary & # 8217 ; s designee ( e.g. , Administrator, SAMHSA ; Director, Division of Workplace Programs ; a contractor ; or other recognized organisation which acts on behalf of the Secretary in implementing these Guidelines ) .
Specimen Fluid or stuff derived from the organic structure and which may be subdivided or concomitantly collected ( if a split specimen is required ) .
Split Specimen A specimen collected at the aggregation site that is unstable or material derived from the organic structure which has been subdivided or concomitantly collected and independently sealed in the presence of the giver. For urine, one nothingness that is subdivided. For hair, one & # 8220 ; harvest & # 8221 ; that is subdivided by strands. For unwritten fluid, one specimen collected that is subdivided or two at the same time collected specimens. For perspiration, a perspiration spot that is subdivided or two separate spots that are applied and removed at the same time.
Standard Reference stuff of known pureness or a solution incorporating a mention stuff at a known concentration.
Substituted A specimen that could non hold been provided by a giver.
Testing Designated Position An employment place within a Federal bureau that has been designated for random testing.
Subpart B & # 8211 ; Specimens
2.1 What types of specimens may be collected?
A Federal bureau may roll up the undermentioned types of specimens as portion of its workplace drug proving plan:
( a ) Urine
( B ) Oral Fluid ( Saliva )
( degree Celsius ) Perspiration
( vitamin D ) Hair
2.2 Under what fortunes can the different types of specimens be collected?
Recommended grounds for specimen type selected are as follows:
Type of Specimen Reason For Test
Urine Pre-employment, random, sensible suspicion/cause,
station accident, return to responsibility, follow-up
Oral Fluid sensible suspicion/cause, station accident
Sweat Return to duty, follow-up
Hair Pre-employment, random, followup
Subpart C & # 8211 ; Drugs
3.1 For which drugs can a specimen be tested?
The Executive Order 12564 defines & # 8220 ; illegal drugs & # 8221 ; as those included in Schedule I or II of the Controlled Substances Act ( CSA ) , but non when used pursuant to a valid prescription or when used as otherwise authorized by jurisprudence. Federal bureau drug proving plans must prove all specimens for marihuana and cocaine usage and may prove for usage of opiates, pep pills, and PCP.
3.2 Can a specimen be tested for extra drugs?
( a ) Reasonable suspicion/cause, or station accident specimens may be tested for any drug listed in Schedule I or II of the CSA.
( B ) A Federal bureau covered by these Guidelines must petition the Secretary in composing for blessing to routinely prove for any drug category non listed in subdivision 3.1. Such blessing shall be limited to the usage of the appropriate scientific discipline and engineering and shall non otherwise bound bureau discretion to prove for any drug tested under paragraph ( a ) of this subdivision.
3.3 Can a specimen be used for other intents?
( a ) Specimens collected pursuant to these Guidelines may be used to prove merely for those drugs included in the Agency workplace drug proving plan. They may non be used to carry on any other analysis or trial unless otherwise authorized by the Guidelines.
( B ) A specimen that tests negative by initial or collateral testing may, nevertheless, be pooled for usage in a research lab & # 8217 ; s internal quality control plan.
( degree Celsius ) These Guidelines are non intended to forbid any Federal bureau specifically authorized by jurisprudence to prove for extra categories of drugs in its workplace drug proving plan.
3.4What is the cutoff concentration for each drug by type of specimen collected?
Urine
Initial Test Cutoff Concentration
( ng/mL )
Marijuana metabolites & # 8230 ; & # 8230 ; & # 8230 ; ..50
Cocaine metabolites & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; ..150
Opiate metabolites & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; ..2000
Phencyclidine & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; 25
Amphetamines & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; .500 Screening must significantly cross-react w/MDMA ( Roughly equal cross-reactivity )
Collateral Test Cutoff Concentration
( ng/mL )
Marijuana metabolite1 & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; ..15
Cocaine metabolite2 & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; ..100
Opiates
Morphine & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; . ? ..2000
Codeine & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; ? & # 8230 ; 2000
6-acetylmorphine & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; ? ..10
Phencyclidine & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; . ? ..25
Amphetamines
d-Amphetamine & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; ..150 & # 8211 ; 250
d-Methamphetamine3 & # 8230 ; & # 8230 ; & # 8230 ; ..150 & # 8211 ; 250
MDMA & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; .. ? ? ? ? ..150 & # 8211 ; 250
MDA & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; . ? ? ? ..150 & # 8211 ; 250
MDEA & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; .. ? ? ? .150 & # 8211 ; 250
1 Delta-9-tetrahydrocannabinol-9-carboxylic acid
2 Benzoylecgonine
3 Specimens must besides incorporate Amphetamine at a concentration * 100 ng/mL
Hair
Initial Test Cutoff Concentration
( pg/mg )
Marijuana metabolites & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; 1.0
Cocaine metabolites & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; 500
Opiate metabolites & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; ..200
Phencyclidine & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; .300
Amphetamines & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; 500 Screening must cross-react w/MDMA
Collateral Test Cutoff Concentration
( pg/mg )
Marijuana metabolite1 & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; 0.05
Cocaine metabolite2 & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; 100
Cocaine & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; .1000
BE/COC ratio *= 0.1
Opiates
Morphine & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; .200
Codeine & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; 200
6-acetylmorphine & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; ..200
Hair 6-AM regulation ( TO BE DETERMINED )
Phencyclidine & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; ..300
Amphetamines
d-Amphetamine & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; . ? 300
d-Methamphetamine & # 8230 ; .. ? ? 300
Hair A regulation & # 8230 ; & # 8230 ; & # 8230 ; ? ? ? ? 50
Methylenedioxymethamphetamine
MDA
MDEA
1 Delta-9-tetrahydrocannabinol-9-carboxylic acid
2 Benzoylecgonine
Perspiration
Initial Test Cutoff Concentration Target Analyte
( ng/ 2.5 mL eluate )
Marijuana metabolites & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; 1.5THC
Cocaine metabolites & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; 10Benzoylecgonine
Opiate metabolites & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; ..10Morphine
Phencyclidine & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; 7.5Phencyclidine
Amphetamines & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; .10d-Methamphetamine
( Amp testing must cross-react w/MDMA )
Collateral Test Cutoff Concentration
( ng/2.5 milliliter eluate )
THC parent drug & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; ..0.5
Cocaine parent drug & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; .. ? 10
Cocaine metabolite2 & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; ? .10
Opiates
Morphine & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; .10
Codeine & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; 10
6-acetylmorphine & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; ..10
Phencyclidine & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; ..7.5
Amphetamines
d-Amphetamine & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; 10
d-Methamphetamine3 & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; 10
Methylenedioxymethamphetamine
MDA
MDEA
2 Benzoylecgonine
3 Specimens must besides incorporate Amphetamine at a
concentration * ( TO BE DETERMINED ) ng/mL
Oral Fluid
Initial Test Cutoff Concentration
( ng/mL )
Marijuana metabolites & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; 4
Cocaine metabolites & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; 20
Opiate metabolites & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; ..40
Phencyclidine & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; . ? 4
Amphetamines & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; .160 Screening must cross-react w/MDMA
Collateral Test Cutoff Concentration
( ng/mL )
THC Parent drug & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; . ? ? ? 2
Cocaine metabolite2 & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; ? & # 8230 ; .8
Opiates
Morphine & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; .. ? 40
Codeine & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; . ? 40
6-acetylmorphine & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; ? ..4
Phencyclidine & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; ? ..2
Amphetamines
d-Amphetamine & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; 160
d-Methamphetamine3 & # 8230 ; & # 8230 ; & # 8230 ; & # 8230 ; 160
Methylenedioxymethamphetamine
MDA
MDEA
2 Benzoylecgonine
3 Specimens must besides incorporate Amphetamine at a
concentration * ( TO BE DETERMINED ) ng/mL
Subpart D & # 8211 ; Collectors
4.1 Who may roll up a specimen?
( a ) An single trained or certified to roll up specimens.
( B ) The direct supervisor of giver may non move as the aggregator when that giver is tested, unless no other aggregator is available.
4.2 What preparation and enfranchisement must a aggregator hold?
( a ) HHS has non established a formal enfranchisement plan for aggregators. However, private sector organisations are encouraged to develop the needed enfranchisement plan. This will assist to guarantee that aggregators have, in fact, been decently trained and certified to roll up specimens as required by the Guidelines.
( B ) To be a aggregator, you must make the followers:
( 1 ) Read and go familiar with the aggregation processs in these Guidelines ;
( 2 ) Read and go familiar with the HHS Specimen Collection Handbook for the specimen being collected ; and
( 3 ) Attain enfranchisement through a recognized aggregator enfranchisement plan for the type ( s ) of specimen ( s ) you are traveling to roll up.
( degree Celsius ) As a aggregator, you must be recertified one time every two old ages to guarantee that you are familiar with current HHS specimen aggregation policies and processs.
( vitamin D ) As a aggregator, you must keep all certification of certification/recertification every bit long as you serve as a aggregator.
4.3 Who can develop and attest aggregators?
( TO BE DETERMINED )
4.4 Under what fortunes must a aggregator be retrained?
( a ) A aggregator needs to be retrained when:
( 1 ) The aggregation process alterations significantly ( e.g. , a new CCF is used ) ; or
( 2 ) The aggregator makes errors that cause trials to be canceled. This will take to a & # 8220 ; aggregator? s cancellation rate & # 8221 ; being an index of public presentation.
( B ) The needed retraining:
( 1 ) Must be focused in the specific country of aggregation processs that caused the trials to be canceled ; and
( 2 ) Be documented in authorship by a trainer.
4.5 What are the aggregator monitoring and support demands for organisations using aggregators?
An organisation ( e.g. , Federal bureau, contractor, wellness clinic ) using the aggregator must make the followers:
( a ) Have an official enfranchisement statement documenting that the aggregator is certified ;
( B ) Retain these official enfranchisement statements every bit long as the individual performs collector maps and for 2 old ages after the aggregator leaves the organisation ; and
( degree Celsius ) Provide to a aggregator the name and telephone figure of the Federal bureau? s representative to reach about jobs or issues that may originate during a specimen aggregation process.
Subpart E & # 8211 ; Collection Sites
5.1 Where can a aggregation for a drug trial take topographic point?
( a ) A aggregation site may be a lasting or impermanent installation located either at the work site or at a distant site.
( B ) The choice of an appropriate aggregation site will depend on the type of specimen being collected.
5.2 What are the demands for a aggregation site?
A aggregation site must hold the followers:
( a ) A suited clean surface for managing the specimen and finishing the needed paperwork ;
( B ) A secure impermanent storage capableness to keep a specimen until it is tested or shipped to the research lab ;
( degree Celsius ) Ability to curtail entree to merely authorised forces during the aggregation ;
( vitamin D ) Ability to curtail entree to aggregation supplies ; and
( vitamin E ) Ability to hive away records firmly.
5.3 How long must collection site records be stored?
Collection site records must be stored for a lower limit of 2 old ages.
5.4 How does the aggregator guarantee the security of a specimen at the aggregation site?
A aggregator must make the following to keep the security of a specimen:
( a ) Do non let unauthorised forces to come in the aggregation site during the aggregation ;
( B ) Perform merely one specimen aggregation at a clip ;
( degree Celsius ) Restrict entree to aggregation supplies before and during the aggregation ;
( vitamin D ) Ensure that you are the lone individual other than the giver to manage the specimen ; and
( vitamin E ) Immediately seal the specimen.
5.5 What are the privateness considerations when roll uping a specimen?
The demands for specimen aggregation are as follows depending on the type of specimen being collected:
( a ) For piss, the giver must hold ocular privateness while supplying the specimen unless:
( 1 ) There is a ground to believe that the giver may change or replace the specimen to be provided ; or
( 2 ) A direct ascertained aggregation was authorized.
( B ) For hair, caput hair is collected unless it is non available. Collection of hair from other countries of the organic structure must be approved in conformity with Agency processs before the aggregation and must be collected utilizing appropriate privateness.
( degree Celsius ) For perspiration, the perspiration spot will be applied by the aggregator to the giver? s upper arm, thorax, or back. The giver must be allowed privateness during the application and remotion of the spot by the aggregator.
( vitamin D ) For unwritten fluid, the aggregation device must be inserted into and removed from the giver? s oral cavity by the giver in the presence of the aggregator. The giver will be observed by the aggregator during this full procedure.
( vitamin E ) A complete description of aggregation processs for each specimen are in the HHS Specimen Collection Handbook for Federal Workplace Drug Testing Programs.
5.6 What supplies are needed at the aggregation site?
( a ) A complete list of the supplies needed to roll up each type of specimen is in the HHS Specimen Collection Handbook for Federal Workplace Drug Testing Programs.
( B ) The enchiridion is available on the undermentioned web site:
Subpart F & # 8211 ; Federal Drug Testing Custody and Control Forms
6.1 What signifier is used to document a specimen aggregation?
( a ) An Office of Management and Budget ( OMB ) approved Federal Drug Testing Custody and Control Form ( CCF ) must be used to document the aggregation of a specimen at the aggregation site.
( B ) The signifier is used to document concatenation of detention from the clip a giver gives the specimen to the aggregator until the specimen is received for proving.
( degree Celsius ) The CCF used for each type of specimen collected is available from a figure of different beginnings. A sample of the OMB approved CCF for each type of specimen is available at the following web site:
( vitamin D ) Federal bureaus and employers regulated by the Department of Transportation ( DOT ) are required to utilize the OMB approved Federal CCF for their workplace drug proving plans.
6.2 What happens if an sanctioned signifier is non available or is non used?
( a ) When the aggregator either by error or as the lone means to carry on a trial under hard fortunes ( e.g. , station accident trial with deficient clip to obtain the CCF ) uses a non-Federal signifier for a regulated aggregation, the usage of a non-Federal signifier is non a ground for the research lab to reject the specimen for proving or for the MRO to call off the trial.
( B ) If the proving installation or the MRO discovers the usage of the wrong signifier, a signed statement must be obtained from the aggregator saying the ground why the Federal CCF was non used for the regulated aggregation.
Subpart G & # 8211 ; Collection Device
7.1 What is a aggregation device?
( a ) A aggregation device is considered to be the following for each type of specimen collected:
( 1 ) For piss, 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 unwritten fluid, it is the applier, tablet, or aspirator placed in the unwritten pit.
( 4 ) For perspiration, it is the spot that is placed on the tegument.
( B ) A aggregation device must non impact or change the specimen collected. The provider of a aggregation device must measure the device to guarantee that it does non impact the specimen collected.
( degree Celsius ) A aggregation device must hold the capableness of being sealed by the aggregator to forestall unauthorised entree to the specimen while at the aggregation site.
7.2 Must the aggregation device be cleared by the FDA?
( a ) If the aggregation device is a alone and built-in portion of the aggregation process and the analytical testing process, it must be cleared by the FDA as a medical device.
( B ) Single-use points ( such as, plastic bottles, plastic bags, foil ) are non alone aggregation devices and, hence, are non required to be cleared by the FDA.
( degree Celsius ) The perspiration spot ( perspiration ) and applier, tablet, or aspirator ( unwritten fluid ) are alone and built-in to roll uping a valid specimen and must be FDA cleared.
Subpart H & # 8211 ; Specimen Collection Procedure
8.1 What must the aggregator do before get downing the aggregation process?
The aggregator must make the followers before get downing the aggregation process:
( a ) Verify the giver? s designation ;
( B ) Supply your designation to the giver if the giver asks ;
( degree Celsius ) Explain the basic aggregation process to the giver ;
( vitamin D ) Request the giver to read the instructions on the dorsum of the CCF ; and
( vitamin E ) Answer any inquiries the giver may hold sing the aggregation process.
8.2 What are the basic demands for roll uping any type of specimen?
The basic demands are as follows:
( a ) The donor removes any unneeded outer garments ( such as, a coat or jacket ) .
( B ) The giver washes and dries his or her custodies anterior to managing the aggregation device. After rinsing custodies, the giver must stay in the presence of the aggregator and must non hold entree to anything that could be used to impact the specimen.
( degree Celsius ) The aggregator and giver observe the choice and gap of the aggregation device used to roll up the specimen.
( vitamin D ) After a specimen is collected, the aggregator inspects the specimen for marks of fiddling.
( vitamin E ) A specimen suspected of being tampered with is sent to the research lab for proving.
( degree Fahrenheit ) The aggregator must acquire permission to instantly roll up another specimen when a tampered specimen is collected. This 2nd specimen must besides be sent to the research lab.
( g ) The aggregator and giver must maintain the specimen in position at all times prior to sealing the aggregation device.
( H ) A tamper-evident label/seal must be used to procure the aggregation device.
( I ) The giver must initial the label and the aggregator must day of the month the label after it is used to procure the aggregation device.
( J ) The aggregator must finish the CCF and administer each transcript as required.
8.3 Where can I happen the aggregation process for each type of specimen?
( a ) A complete description of the aggregation process used to roll up each type of specimen is in the HHS Specimen Collection Handbook for Federal Workplace Drug Testing Programs.
( B ) The enchiridion is available on the undermentioned web site:
Subpart I & # 8211 ; National Laboratory Certification Program
9.1 What is the National Laboratory Certification Program ( NLCP ) ?
( a ) The National Laboratory Certification Program ( NLCP ) is the plan established by HHS to attest research labs before they are permitted to prove specimens that are collected for Federal bureau or federally regulated workplace drug proving plans. The NLCP includes a public presentation testing ( PT ) plan and a laboratory review plan.
( B ) An applicant research lab is required to go through 3 back-to-back sets of initial PT samples and an initial review before going HHS certified.
( degree Celsius ) An HHS certified research lab is required to prove quarterly sets of care PT samples, undergo an review 3 months after being certified, and undergo biannual care reviews thenceforth.
( vitamin D ) A research lab must run into all the pertinent commissariats of these Guidelines in order to measure up for and keep enfranchisement. The Secretary has wide discretion to take appropriate action to guarantee the full dependability and truth of drug testing and coverage, to decide jobs related to drug testing, and to implement all criterions set Forth in these Guidelines. The Secretary has the authorization to publish directives to any research lab suspending the usage of certain analytical processs when necessary to protect the unity of the proving procedure ; telling any research lab to set about disciplinary actions to react to material lacks identified by an review or through proficiency testing ; telling any research lab to direct aliquots of specimens to another research lab for retesting when necessary to guarantee the truth of proving under these Guidelines ; telling the reappraisal of consequences for specimens tested under the Guidelines for private sector clients to the extent necessary to guarantee the full dependability of drug proving for Federal bureaus ; and telling any other action necessary to turn to lacks in drug testing, analysis, specimen aggregation, concatenation of detention, coverage of consequences, or any other facet of the enfranchisement plan.
9.2 How does a research lab apply to the NLCP?
( a ) A research lab interested in going an HHS certified research lab must subject an NLCP application signifier.
( B ) The application signifier requires the applicant research lab to supply elaborate information on both the administrative and analytical processs the research lab proposes to utilize for proving regulated specimens after it is certified.
( degree Celsius ) The NLCP application signifier is available at the following web site:
9.3 What is a PT sample?
( a ) A PT sample is a sample that may incorporate:
( 1 ) The drugs and/or metabolites in the drug classes that each research lab must hold the capableness to prove for ;
( 2 ) Both the parent drug and/or its major metabolite ( s ) ; or
( 3 ) More than one drug category ( but by and large no more than two drug categories ) to copy existent giver specimens.
( B ) The concentration of the drugs and/or metabolites in a PT sample may be:
( 1 ) At least 20 per centum above the cutoff concentration for either the initial trial or the collateral trial ( depending on which is to be evaluated ) ;
( 2 ) Equally low as 40 per centum of the cutoff concentration when the PT sample is designated as a retest sample ; or
( 3 ) At another concentration for a particular intent.
( degree Celsius ) A negative PT sample may non incorporate a mensurable sum of a mark drug and/or metabolite.
( vitamin D ) A PT sample may incorporate an interfering substance ( s ) .
( vitamin E ) For each PT rhythm, the set of PT samples traveling to each research lab will change but, within each calendar twelvemonth, each research lab will hold analyzed the same entire set of samples.
( degree Fahrenheit ) The research lab must, to the greatest extent possible, handle, trial, and describe a PT sample in a mode indistinguishable to that used for a donor specimen, unless otherwise specified.
9.4 What are the public presentation testing demands for an applicant research lab?
An applicant research lab must fulfill the undermentioned standards on 3 back-to-back sets of initial PT samples:
( a ) No false positive consequences ;
( B ) Correctly identify and confirm 90 per centum of the entire drug challenges on the 3 sets of samples ;
( degree Celsius ) The quantitative values for at least 80 per centum of the entire drug challenges must be within? 20 per centum of the deliberate mention group mean ;
( vitamin D ) No quantitative value on a drug concentration may differ by more than 50 per centum from the deliberate mention group mean ; and
( vitamin E ) For an single drug, right detect and quantify at least 50 per centum of the entire drug challenges.
9.5 What are the public presentation testing demands for a certified research lab?
A certified research lab must fulfill the undermentioned standards on the care PT samples to keep its enfranchisement:
( a ) Correctly identify and confirm 90 per centum of the entire drug challenges over two back-to-back PT rhythms ;
( B ) Correctly quantify 80 per centum of the entire drug challenges within? 20 per centum of the appropriate mention or peer group mean as measured over two back-to-back PT rhythms ;
( degree Celsius ) Have no more than one quantitative consequence differ more than 50 per centum from the mark value over two back-to-back PT rhythms ; and
( vitamin D ) For any single drug, right detect and quantify at least 50 per centum of the entire drug challenges.
9.6 What are the review demands for an applicant research lab?
( a ) An applicant research lab is inspected by a squad of at least two inspectors.
( B ) Each inspector conducts an independent rating and reappraisal of all facets of the research lab? s processs and installations utilizing the counsel provided by the Secretary and the National Laboratory Certification Program review checklist.
( degree Celsius ) To go certified, an applicant research lab must fulfill the lower limit demands as stated in these Guidelines.
9.7 What are the review demands for a certified research lab?
( a ) It must undergo an review 3 months after going certified and so inspected biyearly thenceforth.
( B ) A certified research lab is inspected by a squad of at least two inspectors. The figure of inspectors required is dependent on the work load of the research lab.
( degree Celsius ) Each inspector conducts an independent rating and reappraisal of all facets of the research lab? s processs and installations utilizing the counsel provided by the Secretary and the National Laboratory Certification Program review checklist.
( vitamin D ) To stay certified, a research lab must go on to fulfill the lower limit demands as stated in these Guidelines.
9.8 Who may inspect a research lab take parting in the NLCP?
( a ) The Secretary, a Federal bureau utilizing a certified research lab, or the contractor awarded the HHS NLCP contract may inspect a research lab at any clip.
( B ) An person may function as an NLCP inspector if he or she satisfies the undermentioned standards:
( 1 ) Has experience and an educational background similar to that required for either the responsible individual or the certifying scientist as described in subpart K ;
( 2 ) Has read and exhaustively understands the policies and demands contained in these Guidelines and in other NLCP paperss ;
( 3 ) Submits a sketch and certification of makings to HHS ;
( 4 ) Attends NLCP approved preparation ; and
( 5 ) Submits an acceptable review study and has acceptable public presentation as a trainee on an review.
9.9 What happens if a research lab does non fulfill the lower limit demands for either the PT plan or the review plan?
( a ) If an applicant research lab fails to fulfill the demands established for the initial enfranchisement procedure, the applicant research lab must get down the initial enfranchisement procedure from the beginning.
( B ) If a certified research lab fails to fulfill the lower limit demands, the research lab is given a period of clip ( e.g. , 5 or 30 on the job yearss depending on the nature of the issue ) to supply any account for its public presentation and grounds that any lack has been corrected.
( degree Celsius ) A research lab & # 8217 ; s enfranchisement may be revoked, suspended, or no farther action taken depending on the earnestness of the mistakes and whether there is grounds that any lack has been corrected and that current public presentation meets the demands for a certified research lab.
( vitamin D ) A certified research lab may be required to undergo a particular review or to prove extra PT samples, depending on the nature of the public presentation, to verify that any lack has been corrected.
( vitamin E ) If a research lab & # 8217 ; s enfranchisement is revoked or suspended, the research lab is non permitted to prove specimens for Federal bureaus or federally regulated employers until the suspension is lifted or the research lab has successfully completed the enfranchisement demands as a new applicant research lab.
9.10 Where is a list of certified research labs published?
( a ) A list of HHS certified research labs is published monthly in the Federal Register.
( B ) Applicant research labs are non included in the list.
Subpart J & # 8211 ; Blind Samples Submitted by an Agency
10.1 What are the demands for a unsighted sample?
( a ) A unsighted sample must be validated as to its content by the provider utilizing initial and collateral trials.
( B ) The provider must supply information sing the shelf life of the unsighted sample.
( degree Celsius ) If the blind sample is positive, the concentration of the drug it contains must be at least 25 per centum above the cutoff concentration for that drug.
10.2 What are the demands for Federal bureaus to subject blind samples?
( a ) Each Federal bureau is required to hold both negative and positive blind samples submitted with its giver specimens.
( B ) During the initial 90-day period of any new Federal bureau drug proving plan, the bureau must guarantee that at least 5 per centum of the entire figure of giver specimens submitted are unsighted samples.
( degree Celsius ) After the initial 90-day period, the Federal bureau must guarantee that a lower limit of 3 per centum of the entire figure of giver specimens are unsighted samples.
( vitamin D ) Approximately 80 per centum of the blind samples may be negative ( i.e. , certified to incorporate no drug ) and the staying positive for one or more drugs.
( vitamin E ) Each positive sample must be spiked merely with those drugs for which the Federal bureau is proving.
10.3 How is a unsighted sample submitted to the research lab?
( a ) A unsighted sample is either purchased by the Federal bureau and given to the aggregator or the aggregator purchases the unsighted sample from a provider and submits the unsighted sample with the Federal bureau? s giver specimens.
( B ) A unsighted sample is ever submitted utilizing the same CCF as used for a donor specimen. The aggregator provides the needed information to guarantee that the CCF has been decently completed every bit good as supplying fabricated initials on the specimen bottle label/seal. Since there is no giver, the aggregator must bespeak that the sample is a & # 8220 ; blind sample & # 8221 ; on the MRO transcript where the giver would usually supply a signature.
( degree Celsius ) Each Federal bureau must guarantee that the needed blind samples are distributed throughout the entire figure of donor specimens instead than submitted as a individual group of samples.
10.4 What happens if an inconsistent consequence is reported on a unsighted sample?
The Medical Review Officer ( MRO ) is by and large the person who finds that a research lab has reported an inconsistent consequence on a unsighted sample. When such a consequence is identified:
( a ) The MRO must advise both the Federal bureau and the Federal office responsible for keeping the NLCP ; and
( B ) The Federal office responsible for the NLCP will originate an probe to find the cause of the mistake and direct a study to the MRO and the Federal bureau depicting the probe and disciplinary action taken.
Subpart K & # 8211 ; Laboratory Requirements
11.1 What is a Standard Operating Procedure Manual?
( a ) An HHS certified research lab must hold a standard operating process ( SOP ) manual that describes, in item, all laboratory operations. When followed, it ensures that all specimens are tested utilizing the same processs and in a consistent mode. The SOP manual must include, but is non limited to, a elaborate description of the followers:
( 1 ) Chain-of-custody processs ;
( 2 ) Accessioning ;
( 3 ) Security ;
( 4 ) Quality control/quality confidence plans ;
( 5 ) Analytical methods and processs ;
( 6 ) Equipment and care plans ;
( 7 ) Personnel preparation ;
( 8 ) Coverage processs ; and
( 9 ) Computers, package, research lab information direction systems
( B ) All processs in the SOP manual must be in conformity with these Guidelines and NLCP Program Documents.
( degree Celsius ) A transcript of all processs that have been replaced or revised and the day of the months on which they were in consequence must be maintained to let the research lab to recover the processs that were used to prove a specimen.
11.2 What makings must the research lab? s responsible individual ( RP ) have?
A certified research lab must hold at least one person who can presume the professional, organisational, educational, and administrative duties for the full drug proving installation. The minimal makings for the RP are as follows:
( a ) Certified as a research lab manager by the State in forensic or clinical research lab toxicology ; or have a Ph.D. in one of the natural scientific disciplines with an equal undergraduate and alumnus instruction in biological science, chemical science, pharmacological medicine, or toxicology ; or have preparation and experience comparable to a Ph.D. in one of the natural scientific disciplines with extra preparation and laboratory/research experience in biological science, chemical science, pharmacological medicine, or toxicology ; and
( B ) Have appropriate experience in analytical forensic toxicology with accent on the aggregation and analysis of biological specimens for drugs of maltreatment ; and
( degree Celsius ) Have appropriate preparation and/or experience in forensic applications of analytical toxicology, e.g. , publications, tribunal testimony, research refering analytical toxicology of drugs of maltreatment, or other factors which qualify the person as an expert informant in forensic toxicology.
11.3 What are the duties of the RP?
The RP must carry through the undermentioned duties:
( a ) Manage the daily operations of the drug proving research lab even where another person has overall duty for an full multi-specialty research lab.
( B ) Ensure that there are adequate forces with equal preparation and experience to oversee and carry on the work of the drug proving research lab. The RP must guarantee the continued competence of research lab forces by documenting their in-service preparation, reexamining their work public presentation, and verifying their accomplishments.
( degree Celsius ) Maintain a complete, current SOP manual that is available for forces executing trials, and followed by those forces. The SOP manual must be reviewed, signed, and dated by the RP whenever processs are foremost placed into usage or changed or when a new single assumes duty for direction of the drug proving research lab.
( vitamin D ) Maintain a quality confidence plan to guarantee the proper public presentation and coverage of all trial consequences ; monitor acceptable analytical public presentation for all controls and criterions ; supervise quality control proving ; document the cogency, dependability, truth, preciseness, and public presentation features of each trial and trial system.
( vitamin E ) Implement all remedial actions necessary to keep satisfactory operation and public presentation of the research lab in response to quality control systems non being within public presentation specifications, mistakes in consequence coverage or in analysis of public presentation proving consequences. This single must guarantee that sample consequences are non reported until all disciplinary actions have been taken and he or she can guarantee that the consequences provided are accurate and dependable.
( degree Fahrenheit ) Qualify as a certifying scientist for both initial and collateral trial consequences.
11.4 What makings and preparation must an person have to attest a drug trial consequence that is reported by a research lab?
( a ) A attesting scientist ( CS ) must hold the undermentioned makings:
( 1 ) A unmarried man & # 8217 ; s grade in the chemical or biolog
