CHT Laboratory Management & Safety 2

Question 1

What is the primary purpose of running a negative control in a Luminex SAB HLA antibody assay?

Accepted Answer

To establish baseline non-specific background fluorescence for result interpretation

Answer

To verify the positive control exceeded the MFI threshold

Answer

To confirm bead lot number accuracy

Answer

To test for complement activation in normal serum

Question 2

What action should be taken when a reagent lot number changes for a critical assay in a histocompatibility laboratory?

Accepted Answer

Perform parallel testing with the old and new lot to verify equivalent performance before clinical use

Answer

Immediately discard the old lot and begin using the new lot

Answer

Report the lot change to the accrediting body before use

Answer

Request a waiver from CLIA before implementing the new lot

Question 3

Which document describes the step-by-step procedure for performing a test, including safety precautions, reagents, and interpretation criteria?

Accepted Answer

Standard Operating Procedure (SOP)

Answer

Quality Management Plan (QMP)

Answer

Laboratory Developed Test (LDT) validation report

Answer

Corrective Action Report (CAR)

Question 4

What is the significance of turnaround time (TAT) monitoring in a deceased donor histocompatibility laboratory?

Accepted Answer

Rapid TAT is critical because organs have limited viability and allocation decisions cannot wait

Answer

TAT is only important for elective living donor workups

Answer

TAT standards are set by individual labs with no external requirements

Answer

TAT monitoring is only used for billing purposes

Question 5

What is 'delta check' monitoring in the histocompatibility laboratory?

Accepted Answer

Comparing a current patient result to a previous result to flag unexpected changes that may indicate an error

Answer

Checking instrument delta calibration before each run

Answer

Comparing laboratory results to peer group means

Answer

Monitoring room temperature changes that exceed delta thresholds

Question 6

Which regulation requires clinical laboratories to maintain records for a minimum number of years to allow review and audit?

Accepted Answer

CLIA 88 (42 CFR Part 493) record retention requirements

Answer

OSHA bloodborne pathogen standard

Answer

FDA 21 CFR Part 820 quality system regulation

Answer

HIPAA privacy rule minimum necessary standard