Point-of-care testing (POCT) brings its own set of challenges in regard to regulatory compliance. Those laboratories that are inspected and certified by the College of American Pathologists (CAP) are likely quite familiar with the CAP checklists for different laboratory areas and departments. For a great refresher and summary of CAP inspection priorities for POCT, review the Whitehat Communications webinar, CAP is Coming – What do I do now? given by Kathleen David, MT(ASCP), POCT Manager at TriCore Reference Laboratories.
In the May webinar, David discusses how to prepare for a CAP inspection, what you need to do when the inspector arrives, and she reviews the most common CAP citations specific to POCT. She shares great advice for planning ahead, preparing for the actual inspection day, and other tips to ensure you have a quality POCT program that easily meets CAP accreditation requirements.
David’s stellar advice is to maintain your POCT program in a continually ready state, prepared for inspection at any time. At TriCore, the staff prepares a notebook with a helpful checklist that crosswalks their answers to the CAP checklists and is available to whomever assists the inspector. David also advises labs to perform their own internal interim inspections to help uncover any issues prior to the actual inspection day.
Important Inspection Tips
The webinar provides a great review of documents that need to be prepared and available for the inspector, such as:
- Personnel list
- Technical consultant documents
- Updated policies and procedures
- Signed proficiency testing
- Validations and calibrations
Throughout the presentation, David describes the most common CAP inspection citations. For example, she discusses red flags in the following areas:
- Personnel educational requirements and proof of education, by complexity
- Competency assessments (with all six CLIA elements)
- Individualized Quality Control Plan (IQCP) – needs to follow all phases of testing
- Safety concerns
- Reagent labeling and storage
- Documentation of corrective actions
David also discusses the importance of understanding the difference between requirements for POCT training versus competency assessment.
The CAP website is a valuable resource with helpful documents related to POCT inspection readiness.
- CAP POCT Checklist
- Inspecting POC
- Inspecting All Common (AC)
- Compliance Decision Flowchart
- Technical Consultant Qualification & Assessment Form
Whitehat POCT Webinars as an Educational Resource
Orchard Software is an ongoing sponsor of the Whitehat Communications POCT webinar series. Whitehat produces free, educational webinars for laboratories and POCT managers that:
- Provide a wide range of educational and practical topics
- Are delivered by respected experts
- Offer one P.A.C.E.® continuing education contact hour
Orchard is committed to keeping you informed and being a trusted resource you can turn to for industry-related education. As always, we welcome your feedback. Follow us on Twitter at @OrchardSoftware, and feel free to respond to this post by emailing us at firstname.lastname@example.org.