Laboratory Management & Safety Flashcards
6 cards from real CHT practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 Laboratory Management & Safety flashcards as text
What is the primary purpose of running a negative control in a Luminex SAB HLA antibody assay?
Answer: To establish baseline non-specific background fluorescence for result interpretation
Negative controls (normal human serum or buffer) establish the background MFI level; patient MFI values must exceed this background to be considered true positive signals.
What action should be taken when a reagent lot number changes for a critical assay in a histocompatibility laboratory?
Answer: Perform parallel testing with the old and new lot to verify equivalent performance before clinical use
Lot-to-lot verification ensures that the new reagent lot performs equivalently to the current lot on known samples before being used for clinical testing.
Which document describes the step-by-step procedure for performing a test, including safety precautions, reagents, and interpretation criteria?
Answer: Standard Operating Procedure (SOP)
SOPs provide detailed, validated instructions for performing laboratory procedures consistently and are required by CLIA and accreditation standards.
What is the significance of turnaround time (TAT) monitoring in a deceased donor histocompatibility laboratory?
Answer: Rapid TAT is critical because organs have limited viability and allocation decisions cannot wait
Deceased donor typing, crossmatching, and antibody results must be reported rapidly because organ ischemia time is limited and allocation is time-critical.
What is 'delta check' monitoring in the histocompatibility laboratory?
Answer: Comparing a current patient result to a previous result to flag unexpected changes that may indicate an error
Delta checks compare current test results against a patient's prior results; unexpected changes (e.g., new HLA allele appearing) trigger investigation for specimen mix-up or error.
Which regulation requires clinical laboratories to maintain records for a minimum number of years to allow review and audit?
Answer: CLIA 88 (42 CFR Part 493) record retention requirements
CLIA requires laboratories to retain test records, quality control data, and procedural documentation for defined periods (generally 2 years for test records, longer for some categories).