CHT Laboratory Management & Safety

Question 1

Which accreditation organization specifically accredits histocompatibility laboratories in the United States?

Accepted Answer

American Society for Histocompatibility and Immunogenetics (ASHI)

Answer

College of American Pathologists (CAP) only

Answer

Joint Commission (TJC)

Answer

Clinical Laboratory Improvement Amendments (CLIA) only

Question 2

Under CLIA regulations, which category applies to most HLA typing assays performed in histocompatibility labs?

Accepted Answer

High complexity

Answer

Moderate complexity

Answer

Waived

Answer

Provider-performed microscopy

Question 3

What is the required minimum qualification for a laboratory director of an ASHI-accredited histocompatibility laboratory?

Accepted Answer

PhD or MD with specific training and experience in histocompatibility and immunogenetics

Answer

Any doctoral-level scientist with general laboratory management experience

Answer

MT (ASCP) with 5 years of HLA testing experience

Answer

RN with specialized transplant coordinator certification

Question 4

What does proficiency testing (PT) in a histocompatibility lab serve to demonstrate?

Accepted Answer

Laboratory competency in performing and interpreting HLA testing compared to peer labs

Answer

Technologist personal skill competency only

Answer

Equipment calibration and maintenance records

Answer

Patient result turnaround time compliance

Question 5

Which biological safety level (BSL) is appropriate for routine work with human blood and tissue specimens in a histocompatibility lab?

Accepted Answer

BSL-2

Answer

BSL-1

Answer

BSL-3

Answer

BSL-4

Question 6

What is the purpose of a 'chain of custody' for samples in a histocompatibility laboratory?

Accepted Answer

To document the handling, transfer, and testing of specimens to ensure traceability and integrity

Answer

To authorize test ordering by clinicians

Answer

To record refrigerator temperature logs for specimen storage

Answer

To track reagent lot numbers used for each test