CLC Laboratory Accreditation & Certification Processes Flashcards
6 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 6 CLC Laboratory Accreditation & Certification Processes flashcards as text
A laboratory consultant reviews proficiency testing (PT) results and finds the lab failed 2 of 5 samples for a regulated analyte. Under CLIA, what is the immediate consequence?
Answer: Required corrective action and possible testing suspension
Failing PT requires the laboratory to investigate and document corrective action; repeated failures can result in CMS suspending testing for that analyte.
Under CLIA regulations, which individual bears the ultimate responsibility for overall laboratory operations and quality of testing?
Answer: Laboratory director
The CLIA-designated laboratory director bears ultimate regulatory responsibility for all aspects of laboratory operations including test quality and personnel oversight.
A consultant recommends that a laboratory implement a Laboratory Information Management System (LIMS) validation protocol before go-live. This recommendation primarily addresses which accreditation requirement?
Answer: Verification and validation of systems affecting test results
Accreditation standards (CAP, TJC, CLIA) require that any system affecting the accuracy of test results, including LIMS, be validated before implementation.
Which element is NOT typically required as part of a laboratory's written quality management plan for accreditation purposes?
Answer: Staff vacation schedules
Staff vacation schedules are administrative HR documents and are not part of a laboratory quality management plan required for accreditation.
A laboratory consultant is preparing a lab for its first CAP survey. How far in advance should the lab conduct an internal mock survey to allow time for corrective actions?
Answer: 1–3 months before
Conducting a mock survey 1–3 months before the actual CAP inspection allows enough time to identify deficiencies and implement corrective actions before inspectors arrive.
Which of the following best describes an 'unannounced' accreditation survey, as used by CAP?
Answer: Inspectors arrive without advance notice to the laboratory
CAP conducts unannounced inspections where surveyors arrive without prior notification to the laboratory to assess day-to-day compliance under normal operating conditions.