HT Histology Laboratory Management 2 — Questions and Answers
Question 1: Which regulatory body establishes the standards for laboratory quality systems under the Clinical Laboratory Improvement Amendments (CLIA)?
- Centers for Medicare & Medicaid Services (CMS) (Correct answer)
- Food and Drug Administration (FDA)
- Occupational Safety and Health Administration (OSHA)
- College of American Pathologists (CAP)
Correct answer: Centers for Medicare & Medicaid Services (CMS)
CMS is the federal agency responsible for administering CLIA regulations that establish quality standards for all laboratory testing performed on humans in the US.
Question 2: A histology lab is implementing a new tissue processor. Which document must be completed FIRST before the instrument goes into routine service?
- Validation protocol demonstrating acceptable performance (Correct answer)
- Preventive maintenance schedule
- User training log
- Reagent inventory log
Correct answer: Validation protocol demonstrating acceptable performance
Validation must be performed and documented before a new instrument enters routine use to confirm it produces acceptable results for patient testing.
Question 3: Under OSHA's Bloodborne Pathogen Standard, which engineering control BEST reduces needlestick injuries in a histopathology laboratory?
- Self-sheathing needles or sharps with injury protection (Correct answer)
- Posting warning signs near sharps containers
- Providing nitrile gloves to all staff
- Requiring annual bloodborne pathogen training
Correct answer: Self-sheathing needles or sharps with injury protection
Self-sheathing or safety-engineered sharps devices are the preferred engineering control under the Bloodborne Pathogens Standard to eliminate or minimize exposure risk.
Question 4: A laboratory receives a proficiency testing (PT) failure for H&E staining. What is the REQUIRED first step?
- Perform root cause analysis and document corrective actions (Correct answer)
- Immediately suspend H&E testing until the cause is identified
- Contact the accrediting body to request a re-grade
- Reprocess the PT samples using a different staining protocol
Correct answer: Perform root cause analysis and document corrective actions
CLIA requires that laboratories investigate PT failures through root cause analysis and implement documented corrective actions within a specified timeframe.
Question 5: Which temperature range is required for long-term paraffin block storage to preserve antigenicity for future immunohistochemistry?
- Room temperature (20–25°C) in a cool, dark area (Correct answer)
- Refrigerator (2–8°C)
- Freezer (−20°C)
- Deep freezer (−80°C)
Correct answer: Room temperature (20–25°C) in a cool, dark area
Paraffin blocks are best stored at room temperature in a cool, dark environment; refrigeration can cause moisture condensation that degrades block quality.
Question 6: A laboratory manager notices that xylene consumption has doubled over the past month without a corresponding increase in caseload. What is the MOST likely cause?
- Leaking valves or tubing on the tissue processor (Correct answer)
- Increased use of xylene-substitute clearing agents
- Higher tissue thickness on sections cut
- Staff using xylene for additional cleaning tasks
Correct answer: Leaking valves or tubing on the tissue processor
Leaking valves or tubing cause continuous loss of reagent and are the most common mechanical explanation for unexplained reagent overuse on automated processors.
Question 7: Which component of a laboratory quality management system is responsible for defining the acceptable range of results for a given test before it is reported?
- Establishment of reference intervals and reportable ranges (Correct answer)
- Proficiency testing program
- Corrective action log
- Personnel competency assessment
Correct answer: Establishment of reference intervals and reportable ranges
Reference intervals and reportable ranges define the clinically acceptable result boundaries and must be established and documented before patient results are reported.
HT Histology Laboratory Management 2
Which regulatory body establishes the standards for laboratory quality systems under the Clinical Laboratory Improvement Amendments (CLIA)?