CPC CPC Quality Assurance & Laboratory Procedures

Question 1

What certification must a laboratory hold to perform federally regulated workplace drug testing under DOT?

Accepted Answer

HHS (SAMHSA) certification as a National Laboratory Certification Program (NLCP) certified laboratory

Answer

CAP (College of American Pathologists) accreditation only

Answer

CLIA (Clinical Laboratory Improvement Amendments) certification only

Answer

ISO 15189 international laboratory accreditation

Question 2

What is the primary testing method used by certified laboratories as the initial screen for drug metabolites in urine?

Accepted Answer

Immunoassay

Answer

Gas chromatography-mass spectrometry (GC-MS)

Answer

High-performance liquid chromatography (HPLC)

Answer

Enzyme-linked immunosorbent assay (ELISA) with mass confirmation

Question 3

What confirmatory testing method is required under HHS guidelines when an initial immunoassay screen is positive?

Accepted Answer

Gas chromatography-mass spectrometry (GC-MS) or liquid chromatography-mass spectrometry (LC-MS/MS)

Answer

A second immunoassay using a different antibody reagent

Answer

A point-of-care device test at the collection site

Answer

A breathalyzer confirmation for all drug classes

Question 4

Why is a split specimen collected under DOT regulations?

Accepted Answer

To allow the donor to request independent retesting of the B specimen if they dispute the primary result

Answer

To provide a backup specimen in case the primary vial breaks during shipping

Answer

To allow two different laboratories to test the same specimen simultaneously

Answer

To ensure there is sufficient specimen volume for all required validity tests

Question 5

How long must a laboratory retain a confirmed positive specimen before it may be discarded?

Accepted Answer

At least one year from the date of the laboratory report

Answer

At least 30 days from the date of the laboratory report

Answer

At least five years from the date of the laboratory report

Answer

At least six months from the date of the laboratory report

Question 6

What is the purpose of a laboratory's quality control (QC) samples in the drug testing process?

Accepted Answer

To verify that the analytical equipment and procedures are performing accurately and within acceptable limits

Answer

To train new laboratory technicians on specimen handling procedures

Answer

To provide reference samples for the MRO when reviewing results

Answer

To test donors who are unable to provide a urine specimen