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Drug Testing

The document outlines the requirements and procedures for drug testing in laboratories, including facility specifications, specimen collection protocols, and personnel qualifications. It details the parameters for specimen validity, tampering issues, analytical methods for screening and confirmatory tests, and specimen retention guidelines. Additionally, it emphasizes the importance of proper documentation and lab records for maintaining quality and compliance in drug testing practices.

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Akire Sayara
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24 views20 pages

Drug Testing

The document outlines the requirements and procedures for drug testing in laboratories, including facility specifications, specimen collection protocols, and personnel qualifications. It details the parameters for specimen validity, tampering issues, analytical methods for screening and confirmatory tests, and specimen retention guidelines. Additionally, it emphasizes the importance of proper documentation and lab records for maintaining quality and compliance in drug testing practices.

Uploaded by

Akire Sayara
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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DRUG TESTING IN THE

LABORATORY
Drug Testing
• Facilities
• Screening: at least 20 sq.m. floor area with a 10
sq.m. working area
• Confirmatory: at least 60 sq.m. floor area with a 30
sq.m. working area
• can accommodate at least 5 patients at one time
• handwashing area, toilet stalls
Specimen Collection
• Must be at a permanent drug testing facility except for
remote collection which is allowed in the following:
• Workplace/school/jail or prison/rehabilitation center for:
• Random
• Follow-up
• Reasonable suspicion/cause
• Crime scene and post-accident
• Persons who are critically-ill or disabled
• In these cases, sample validity tests must be performed
Parameters for Validity Test
• Color
• Appearance: clear
• Odor: aromatic
• Volume: 30-60 mL
• Temperature: 32-38 degrees C
• pH: 4.0-9.0
• Specific Gravity: 1.003-1.030
Tampering of Specimens
• ADULTERATION
• with a substance not normally present in the test
specimen
• Addition of juice, illicit drugs
• Taking of drug screens like aspirin, niacin, and zinc sulfate
which interfere with drug analysis
• ‘doping samples’: adding chemicals to urine
• e.g. bleach, ammonia/liquid soap/table salt, hydrogen peroxide,
vinegar
Tampering of Specimens
• DILUTION
• less than normal physiological constituents
• Internal dilution: plenty of water, diuretics
• External dilution: adding water to specimen

• SUBSTITUTION: submission of switched or replaced sample


Personnel
• HEAD OF THE LAB (Screening)
• Clinical Pathologist or any licensed physician w/ certification
in Clinical Laboratory Management by the DOH
• 10: maximum screening labs a physician can handle (within
5 km radius)
• HEAD OF THE LAB (Confirmatory)
• physician/pathologist with 2 years experience in analytical
toxicology
• chemist with a master's degree and 2 years experience in
analytical chemistry
Personnel
• ANALYST (Screening)
• either a chemist, med tech, pharmacist, or chemical engineer with
training
• ANALYST (Confirmatory)
• Required: full-time chemist with training in chromatography and mass
spectroscopy and either a med tech, pharmacist, or chemical engineer
with training in screening
• The personnel verify chain of custody, perform test, certify results,
perform QA
• AUTHORIZED SPECIMEN COLLECTOR: instructs, assists, and
receives/inspects specimens
Documents
• Custody and Control Form • Chain of Custody Document
• A BHFS-approved form • The form/s used to document the
security of the specimen and all
used to document the aliquots of the specimen during
collection, transport, testing and storage
security, and test results of • Includes the names and signatures
the specimen of all individuals who handled the
• donor's info specimen and the date and purpose
of access
• CoC document
• status of specimen:
temperature, appearance
• drug test requested
• result of test
Drug Testing Specimens
• URINE: most common
• 60 mL is needed
• prolonged storage at (-20 degrees C)
• collected in a 30-60 mL polyethylene specimen container
• Saliva
• 2 mL of saliva collected in a 30 mL polyethylene specimen
container
Drug Testing Specimens
• Blood
• most expensive, most accurate
• plain test tube, 10 mL (sample: minimum of 5 mL)
• No standardized procedure available
• Sweat
• FDA-approved sweat patch (worn 1-2 weeks)
• Hair
• 100 mg hair in 200 mg capacity self-sealing transparent plastic bag
• expensive and tedious
• detects chronic substance abuse
Specimen Handling
• Observed specimen collection
• Ensure the integrity of urine specimen
• Coloring agents in toilet bowl
• Removal of unnecessary outer garments, body search
• Washing and drying of hands prior to urination
• Checking urine volume, temperature, color, and appearance
• Labeling of the specimen
• Date/time of collection, signature of client and ASC, and specimen
ID number
Specimen Retention
• Negative: 5 days after receipt of result
• Positive, adulterated, substituted, or invalid: minimum of 15
days upon receipt of result; may be extended for up to a year
upon request
Analytical Methods
• Screening test: presence or absence of a drug
• Presumptive positive (at or above the cutoff level)
• Presumptive negative (below cutoff level, drug may be
absent or present)
• TAT: 30 minutes
• Confirmatory test: presence or absence, identity of
the metabolite, concentration of the drug
• TAT: 15 days

• RESULTS ARE VALID FOR ONE YEAR


Analytical Methods
• Screening
• FDA-DOH-approved testing kits using
immunoassay
• Instrumented screening method
• Immunoassay: ELISA, fluorescence
polarization immunoassay
• Chromatographic: TLC, HPLC
Analytical Methods
• Confirmatory
• Gold standard: gas chromatography-mass spectrometry (GC-MS)
• Qualitative chemical characterization
• Quantitation and determination of concentration of analyte
Drug Testing
• Re-test
• lab satisfaction for quality validation
• replicate test to check the initial test result of same sample
• Challenge test
• replicate test when confirmatory results are legally questioned
• complainant will pay the test fee
Drug Testing
Drug Testing
• Lab Records
• training records
• custody and control form
• info on the specimen, date/time of collection, name of lab, chain of custody form
• QA records
• reports
• calculations in test results
• License validity
• Screening Lab: 1 year
• Confirmatory Lab: 2 years

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