CHT Laboratory Management & Safety 1 — Questions and Answers
Question 1: Which accreditation organization specifically accredits histocompatibility laboratories in the United States?
- American Society for Histocompatibility and Immunogenetics (ASHI) (Correct answer)
- College of American Pathologists (CAP) only
- Joint Commission (TJC)
- Clinical Laboratory Improvement Amendments (CLIA) only
Correct answer: American Society for Histocompatibility and Immunogenetics (ASHI)
ASHI provides specialty accreditation for histocompatibility laboratories, setting standards specific to HLA testing, crossmatching, and transplant immunology beyond CLIA requirements.
Question 2: Under CLIA regulations, which category applies to most HLA typing assays performed in histocompatibility labs?
- High complexity (Correct answer)
- Moderate complexity
- Waived
- Provider-performed microscopy
Correct answer: High complexity
HLA typing assays require specialized training, complex interpretation, and quality oversight, placing them in the high complexity category under CLIA 88 regulations.
Question 3: What is the required minimum qualification for a laboratory director of an ASHI-accredited histocompatibility laboratory?
- PhD or MD with specific training and experience in histocompatibility and immunogenetics (Correct answer)
- Any doctoral-level scientist with general laboratory management experience
- MT (ASCP) with 5 years of HLA testing experience
- RN with specialized transplant coordinator certification
Correct answer: PhD or MD with specific training and experience in histocompatibility and immunogenetics
ASHI standards require the laboratory director to hold a doctoral degree (PhD or MD) with documented training and competency specifically in histocompatibility and immunogenetics.
Question 4: What does proficiency testing (PT) in a histocompatibility lab serve to demonstrate?
- Laboratory competency in performing and interpreting HLA testing compared to peer labs (Correct answer)
- Technologist personal skill competency only
- Equipment calibration and maintenance records
- Patient result turnaround time compliance
Correct answer: Laboratory competency in performing and interpreting HLA testing compared to peer labs
PT programs like those from CAP or ASHI send unknown samples to labs; correct results compared to peer laboratory consensus demonstrate ongoing testing proficiency as required by CLIA.
Question 5: Which biological safety level (BSL) is appropriate for routine work with human blood and tissue specimens in a histocompatibility lab?
- BSL-2 (Correct answer)
- BSL-1
- BSL-3
- BSL-4
Correct answer: BSL-2
BSL-2 practices are standard for clinical labs handling human blood and tissues with potential exposure to bloodborne pathogens like HIV and HBV.
Question 6: What is the purpose of a 'chain of custody' for samples in a histocompatibility laboratory?
- To document the handling, transfer, and testing of specimens to ensure traceability and integrity (Correct answer)
- To authorize test ordering by clinicians
- To record refrigerator temperature logs for specimen storage
- To track reagent lot numbers used for each test
Correct answer: To document the handling, transfer, and testing of specimens to ensure traceability and integrity
Chain of custody documentation tracks every person who handled a specimen and every step from collection to result, ensuring traceability and defending result integrity.
CHT Laboratory Management & Safety 1
Which accreditation organization specifically accredits histocompatibility laboratories in the United States?