CLC Regulatory Compliance & Safety Standards 2

Question 1

Under OSHA's Bloodborne Pathogens Standard (29 CFR 1910.1030), how often must employers offer the hepatitis B vaccine to at-risk laboratory employees?

Accepted Answer

At time of initial assignment to tasks involving potential exposure

Answer

The standard requires the hepatitis B vaccine series to be offered at no cost to employees within 10 working days of initial assignment to tasks with occupational exposure risk.

Question 2

Which regulatory body enforces the Clinical Laboratory Improvement Amendments (CLIA) in the United States?

Accepted Answer

Centers for Medicare & Medicaid Services (CMS)

Answer

CMS is responsible for CLIA program oversight, which regulates laboratory testing on human specimens to ensure accuracy, reliability, and timeliness of patient test results.

Question 3

A laboratory receives a new chemical with an unfamiliar hazard profile. Under OSHA's Hazard Communication Standard (HazCom), what must be present before lab personnel use the chemical?

Accepted Answer

A Safety Data Sheet (SDS) accessible in the work area

Answer

HazCom requires that an SDS be readily accessible to employees during each work shift for every hazardous chemical in the workplace before use begins.

Question 4

Under CAP accreditation requirements, what is the minimum retention period for quality control records in a clinical laboratory?

Accepted Answer

2 years

Answer

CAP requires that QC records be retained for at least 2 years, though some specific records (e.g., transfusion records) have longer retention requirements.

Question 5

When a laboratory's CLIA certificate of waiver is expired, what is the laboratory legally permitted to do?

Accepted Answer

Perform no testing until the renewed certificate is received

Answer

A laboratory must not perform any testing after its CLIA certificate expires; testing must cease until a valid certificate is issued.

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CLC Regulatory Compliance & Safety Standards 2