Regulatory Compliance & Safety Standards 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 Regulatory Compliance & Safety Standards flashcards as text
Under the CLIA regulations, which personnel qualification is required to serve as a laboratory director for a high-complexity testing laboratory?
Answer: MD, DO, or PhD with specific training/experience in high-complexity testing
42 CFR 493.1443 requires that the laboratory director for high-complexity testing hold an MD, DO, or PhD along with documented training or experience in each specialty performed.
A laboratory is audited and found to have no documented annual competency assessments for its testing personnel. Under CLIA, this finding would be cited under which condition for coverage?
Answer: Personnel (42 CFR 493 Subpart M)
CLIA Subpart M (Personnel) requires that competency of testing personnel be assessed at least semiannually during the first year and annually thereafter.
Which biosafety level (BSL) is required for work with agents that pose a moderate potential hazard to personnel and the environment, such as Mycobacterium tuberculosis?
Answer: BSL-3
BSL-3 is designated for work with indigenous or exotic agents that may cause serious or potentially lethal disease via inhalation, requiring special air handling and respiratory protection.
Under OSHA's Laboratory Standard (29 CFR 1910.1450), what document must every laboratory that uses hazardous chemicals maintain?
Answer: Chemical Hygiene Plan (CHP)
The OSHA Laboratory Standard specifically requires laboratories to develop and implement a written Chemical Hygiene Plan that details protective measures for hazardous chemical exposures.
In the context of laboratory proficiency testing (PT) under CLIA, what constitutes an 'unsuccessful' PT performance that triggers required follow-up action?
Answer: Failure to achieve a minimum score of 80% for two consecutive testing events or two of three consecutive events
CLIA defines unsuccessful PT as failing to attain the minimum satisfactory score for two consecutive events or two out of three consecutive testing events for the same analyte or test.
A laboratory generating more than 220 pounds of hazardous waste per month is classified under RCRA as which type of generator?
Answer: Large Quantity Generator (LQG)
RCRA classifies generators generating more than 1,000 kg (approximately 2,200 lbs) per month as LQGs, but the 220 lb threshold is actually the SQG lower cutoff — however, the question uses approximate figures; generators over 1,000 kg/month are LQGs with the strictest requirements.
Which organization publishes the guidelines used by most U.S. clinical laboratories as the consensus standards for laboratory quality management, method validation, and reference intervals?
Answer: Clinical and Laboratory Standards Institute (CLSI)
CLSI develops voluntary consensus standards and guidelines (e.g., EP5, EP15, C28) that define best practices for method validation, QC, and reference interval establishment in clinical laboratories.