CLIA Safety & Risk Management in Clinical Labs 5 — Questions and Answers
Question 1: CLIA requires that patient test results with critical values be reported to the authorized person within a specified timeframe. The PRIMARY purpose of this requirement is to:
- Reduce laboratory liability for malpractice claims
- Enable prompt clinical intervention to prevent patient harm (Correct answer)
- Satisfy accreditation body documentation standards
- Allow billing codes to be assigned more quickly
Correct answer: Enable prompt clinical intervention to prevent patient harm
Critical value reporting requirements exist to ensure clinicians receive life-threatening results in time to intervene and prevent patient harm.
Question 2: A laboratory receives a corrected patient report after discovering a transcription error in the original result. Under CLIA, the corrected report must:
- Replace the original report with no record of the change
- Clearly identify it as a corrected report and include the original result for comparison (Correct answer)
- Be sent only to the ordering physician, not added to patient records
- Be submitted to CMS within 24 hours of discovery
Correct answer: Clearly identify it as a corrected report and include the original result for comparison
CLIA requires corrected reports to be clearly identified as corrections and to include sufficient information (such as the original result) to allow the corrected report to be differentiated from the original.
Question 3: In the context of laboratory safety, the term 'universal precautions' means treating which specimens as potentially infectious?
- Only specimens from patients with known HIV or hepatitis diagnoses
- All human blood and certain other body fluids, regardless of patient diagnosis (Correct answer)
- Only specimens with biohazard labels attached
- Specimens from ICU and emergency department patients only
Correct answer: All human blood and certain other body fluids, regardless of patient diagnosis
Universal precautions require treating all human blood and specified body fluids as potentially infectious, regardless of the patient's known diagnosis.
Question 4: A laboratory conducting high-complexity testing must have a technical supervisor who meets which minimum CLIA qualification?
- High school diploma plus 10 years of laboratory experience
- Earned doctoral, master's, or bachelor's degree in a chemical, physical, or biological science with specific experience requirements (Correct answer)
- Any ASCP certification regardless of degree level
- Completion of an accredited medical assistant program
Correct answer: Earned doctoral, master's, or bachelor's degree in a chemical, physical, or biological science with specific experience requirements
CLIA specifies that technical supervisors for high-complexity testing must hold at least a bachelor's degree in a relevant science field with defined years of laboratory training and experience.
Question 5: A laboratory's root cause analysis (RCA) of a specimen labeling error reveals that the collection tube rack design allows mix-ups between patient tubes. The MOST effective corrective action based on the hierarchy of controls is:
- Retrain all phlebotomists on proper labeling procedures
- Redesign the rack to physically prevent tube mix-ups (engineering control) (Correct answer)
- Post reminder signs at collection stations (administrative control)
- Require phlebotomists to wear color-coded PPE per patient (PPE control)
Correct answer: Redesign the rack to physically prevent tube mix-ups (engineering control)
Engineering controls are higher on the hierarchy of controls than administrative controls or PPE, making redesigning the physical environment the most effective long-term corrective action.
Question 6: Which CLIA provision requires laboratories to retain patient testing records, including all QC data and instrument maintenance logs, for a minimum of 2 years?
- The proficiency testing enrollment requirement
- The record retention requirement under CLIA 42 CFR 493.1105 (Correct answer)
- The personnel file maintenance standard
- The physical plant inspection guideline
Correct answer: The record retention requirement under CLIA 42 CFR 493.1105
CLIA at 42 CFR 493.1105 mandates a minimum 2-year retention period for test records, QC data, and maintenance logs to support quality oversight and investigation.
Question 7: During a CLIA inspection, a surveyor finds that the laboratory has no documented procedure for verifying instrument function after a significant repair. This finding represents a deficiency in which quality system essential?
- Proficiency testing
- Process improvement through corrective action and preventive action (CAPA)
- Equipment maintenance and function checks (Correct answer)
- Personnel competency assessment
Correct answer: Equipment maintenance and function checks
Failure to document and verify instrument function after significant repairs is a deficiency in the equipment maintenance and function check quality system essential under CLIA.
CLIA Safety & Risk Management in Clinical Labs 5
CLIA requires that patient test results with critical values be reported to the authorized person within a specified timeframe.
The PRIMARY purpose of this requirement is to: