医疗机构合规 12 项
Blood Glucose Point-of-Care Testing (CLIA Waived) Audit
此检查清单为英文版。
Audit of waived blood-glucose point-of-care testing including operator competency, quality control, reagent handling, and result documentation.
CLIA 42 CFR 493 SubpartCAP POC checklistFDA/manufacturer IFU
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Regulatory & Operator Controls
- Is a valid CLIA Certificate of Waiver (or higher) held that covers the glucose testing performed? *
- Are testing personnel trained and competency-assessed on the specific glucose meter? *
- Are manufacturer instructions for use followed without modification, as required for waived tests? *
Quality Control & Reagents
- Is quality control performed at the frequency specified by the manufacturer or facility policy? *
- Are test strips and control solutions stored per manufacturer conditions and used within expiration? *
- Are out-of-range QC results investigated and resolved before patient testing resumes? *
Result Documentation & Correlation
- Are patient results, along with operator ID and meter ID, recorded in the medical record? *
- Are critical glucose values reported to the provider and read back per policy? *
- Is meter-to-laboratory correlation performed at defined intervals?
Oversight & Records
- Is the point-of-care testing program overseen by a laboratory director or POC coordinator? *
- Are QC, maintenance, and competency records retained per CLIA retention requirements? *
- Are lot-to-lot verification and linearity/reportable-range checks performed as applicable?
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