HTL Regulatory Compliance & Accreditation 2

Question 1

Under CLIA regulations, which personnel qualification is required for a high-complexity histology laboratory director?

Accepted Answer

MD, DO, or doctoral degree with appropriate training

Answer

CLIA mandates that high-complexity lab directors hold an MD, DO, or doctoral-level degree with appropriate laboratory training and experience.

Question 2

CAP accreditation checklists require that a laboratory's reagent lot-change records demonstrate which action?

Accepted Answer

Parallel testing comparing old and new lots

Answer

CAP requires documentation of parallel or correlation testing when reagent lots change to ensure consistent staining results.

Question 3

Which federal agency enforces CLIA regulations for clinical laboratories in the United States?

Accepted Answer

CMS

Answer

The Centers for Medicare & Medicaid Services (CMS) is responsible for implementing and enforcing CLIA regulations.

Question 4

A histology laboratory receives an unannounced CAP inspection. The inspector finds no temperature log for the tissue processor. This is most likely cited as a:

Accepted Answer

Phase II deficiency requiring a plan of correction

Answer

CAP uses a Phase I/Phase II citation system; missing required documentation like temperature logs is typically a Phase II deficiency requiring a written plan of correction.

Question 5

Under OSHA's Bloodborne Pathogens Standard, a histotechnologist exposed to a splash of formalin-fixed tissue must primarily follow which plan?

Accepted Answer

Exposure Control Plan

Answer

OSHA's Bloodborne Pathogens Standard requires laboratories to maintain an Exposure Control Plan that outlines procedures following potential exposure incidents.

(HTL) Histotechnology Certification Practice Test

(HTL) Histotechnology Certification Practice Test

HTL Regulatory Compliance & Accreditation 2