HTL Regulatory Compliance & Accreditation 3 — Questions and Answers
Question 1: The Joint Commission's Laboratory Accreditation Program uses which framework to organize its laboratory standards?
- ISO 15189 technical requirements
- NPSG and EC chapters (Correct answer)
- CLIA complexity categories
- CAP checklist phases
Correct answer: NPSG and EC chapters
The Joint Commission organizes its laboratory standards under chapters including National Patient Safety Goals (NPSG) and Environment of Care (EC), among others.
Question 2: Under OSHA's Hazard Communication Standard (HazCom), Safety Data Sheets (SDS) must be accessible to employees:
- Only during normal business hours at the supervisor's desk
- At all times during each work shift in the work area (Correct answer)
- Within 24 hours of a written request
- Electronically only via a central server
Correct answer: At all times during each work shift in the work area
OSHA HazCom requires that SDS be readily accessible to employees in their work area at all times during their work shift.
Question 3: A histology lab's QC chart shows that hematoxylin staining intensity has trended downward over 10 consecutive days without crossing a control limit. This pattern is best described as:
- Random error requiring no action
- Systematic shift indicating a trend requiring investigation (Correct answer)
- Acceptable variation within reference range
- Instrument calibration failure
Correct answer: Systematic shift indicating a trend requiring investigation
Ten consecutive points moving in one direction is a recognized trend rule (Westgard rule 10x) indicating systematic error requiring investigation even before a control limit is breached.
Question 4: Which CLIA certificate is required for a laboratory that performs only Pap smear screening without any other moderate- or high-complexity tests?
- Certificate of Waiver
- Certificate of Compliance (Correct answer)
- Certificate of Accreditation
- Provider-Performed Microscopy certificate
Correct answer: Certificate of Compliance
Pap smear screening is classified as high-complexity under CLIA, requiring a Certificate of Compliance or Accreditation, making Certificate of Compliance the appropriate standard CLIA certificate for such labs.
Question 5: CAP requires that competency assessment for histotechnology staff be performed at which minimum frequency after the initial evaluation period?
- Monthly for the first year, then quarterly
- Annually (Correct answer)
- Every 6 months indefinitely
- Only when a new procedure is introduced
Correct answer: Annually
CAP requires that competency assessments be performed at least annually for all laboratory personnel performing patient testing.
Question 6: Under HIPAA, a histotechnologist who inadvertently views a patient's surgical pathology report while printing QC logs has a primary obligation to:
- Report the incident to the patient directly
- Not disclose the information and follow the laboratory's privacy policy (Correct answer)
- Immediately notify the laboratory's legal counsel
- File a breach report with HHS within 24 hours
Correct answer: Not disclose the information and follow the laboratory's privacy policy
HIPAA requires that employees who inadvertently access PHI must maintain confidentiality and comply with the facility's established privacy and breach notification policies.
Question 7: A CAP inspector requests documentation of the laboratory's analytical measurement range (AMR) for a quantitative IHC assay. This record demonstrates:
- The cost-effectiveness of the assay
- The interval of values over which results have been shown to be accurate (Correct answer)
- The turnaround time performance metric
- The number of cases processed per instrument run
Correct answer: The interval of values over which results have been shown to be accurate
The AMR defines the range of analyte concentrations over which a quantitative method has been validated to produce accurate results.
HTL Regulatory Compliance & Accreditation 3
The Joint Commission's Laboratory Accreditation Program uses which framework to organize its laboratory standards?