Laboratory Operations & Quality Management Flashcards
7 cards from real CLC practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Laboratory Operations & Quality Management flashcards as text
A laboratory QC chart shows a trend of six consecutive QC values progressively increasing toward the upper control limit. Which Westgard rule has been violated?
Answer: 6x trend rule
The 6x trend rule (also called the 6T rule) is violated when six consecutive QC values move progressively in one direction, indicating a systematic trend.
When validating a quantitative assay's linearity, which CLSI guideline should the laboratory follow?
Answer: EP6-A
CLSI EP6-A provides the protocol for evaluating the linearity of quantitative measurement procedures across the analytical measurement range.
A laboratory director is implementing a quality indicator program. Which metric best monitors the pre-analytical phase of the testing process?
Answer: Rate of hemolyzed specimens rejected per 1,000 specimens received
Hemolysis rejection rate is a pre-analytical quality indicator that monitors specimen collection and handling quality before testing begins.
A CLC is conducting a gap analysis before an accreditation inspection. The most efficient approach is to compare the laboratory's current practices against:
Answer: The applicable accreditation standards and regulatory requirements checklist
A gap analysis measures current practice against the specific requirements of the applicable accreditation standards to identify non-conformances before inspection.
Under the HITECH Act, a laboratory must notify affected individuals of a breach involving unsecured PHI within:
Answer: Without unreasonable delay and no later than 60 days after discovery
HITECH requires notification without unreasonable delay and within 60 calendar days of discovery of a breach of unsecured PHI.
A reference laboratory reports a critical potassium value of 6.8 mEq/L on a specimen submitted by a satellite clinic. Who is ultimately responsible for ensuring the critical value is communicated to the treating clinician?
Answer: The ordering laboratory or clinic that submitted the specimen
The ordering (sending) laboratory or clinic bears responsibility for critical value communication to the treating clinician when specimens are referred to a reference laboratory.
A laboratory uses a lot-to-lot validation approach when changing QC material lots. The primary goal of this process is to:
Answer: Establish new mean and SD target values appropriate for the new lot before patient testing resumes
Lot-to-lot validation establishes laboratory-specific mean and SD values for the new QC lot by running it concurrently with the old lot before it becomes the primary QC material.