HTL Regulatory Compliance & Accreditation 2 — Questions and Answers
Question 1: Under CLIA regulations, which personnel qualification is required for a high-complexity histology laboratory director?
- Associate degree in biological sciences
- MD, DO, or doctoral degree with appropriate training (Correct answer)
- Bachelor's degree with 2 years lab experience
- HTL(ASCP) certification only
Correct answer: MD, DO, or doctoral degree with appropriate training
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?
- Disposal of the old lot within 24 hours
- Parallel testing comparing old and new lots (Correct answer)
- Director signature on each new lot label
- Submission to the FDA before use
Correct answer: Parallel testing comparing old and new lots
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?
- FDA
- OSHA
- CMS (Correct answer)
- CDC
Correct answer: CMS
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:
- Phase I deficiency requiring immediate corrective action
- Phase II deficiency requiring a plan of correction (Correct answer)
- Observation with no formal citation required
- Critical deficiency requiring immediate suspension
Correct answer: Phase II deficiency requiring a plan of correction
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?
- Chemical Hygiene Plan
- Exposure Control Plan (Correct answer)
- Hazard Communication Plan
- Emergency Action Plan
Correct answer: Exposure Control Plan
OSHA's Bloodborne Pathogens Standard requires laboratories to maintain an Exposure Control Plan that outlines procedures following potential exposure incidents.
Question 6: Proficiency testing (PT) specimens in a CLIA-certified laboratory must be tested:
- Using only validated reference methods
- In the same manner as patient specimens without special handling (Correct answer)
- By the most experienced technologist only
- After all patient work is complete each day
Correct answer: In the same manner as patient specimens without special handling
CLIA requires that PT samples be integrated into routine workflow and tested identically to patient specimens to ensure valid performance assessment.
Question 7: Which document must a CAP-accredited laboratory have in place to describe actions taken when test results fall outside acceptable limits?
- Standard operating procedure manual
- Corrective action policy (Correct answer)
- Quality management plan
- Competency assessment record
Correct answer: Corrective action policy
CAP requires a formal corrective action policy that specifies how the laboratory responds when QC or PT results are out of acceptable range.
HTL Regulatory Compliance & Accreditation 2
Under CLIA regulations, which personnel qualification is required for a high-complexity histology laboratory director?