Maintaining Compliance with Point-of-Care Testing

Continuing Education Credits

• P.A.C.E.® Contact Hours: 1 hour(s)
• Florida Board of Clinical Laboratory Science CE Credit Hours -
  Supervision/Administration, Quality Control/Quality Assurance, and Safety: 1 hour(s)

Objectives

• Define and differentiate point-of-care and waived testing.
• Outline staff training requirements for point-of-care testing (POCT).
• Describe staff competency testing required for compliance for POCT.
• Specify policy and procedure requirements for POCT.
• Discuss proficiency testing requirements for POCT.

Course Outline

• Definitions of Waived Testing and Point-of-Care Testing
• Definitions: Point-of-Care Testing and Waived Testing
• Emergency Use Authorizations
• ABC Children's hospital has urine chemistry testing in four locations. Which of the following locations qualify as POCT sites?
• All POCT is waived, but all waived testing is not POCT.
• A POCT site performs some moderately complex testing and some waived testing. Which of the following would be a true statement about compliance requir...
• CLIA Certificates Differentiated
• A POCT site has a certificate of waiver. The facility has applied to perform non-waived testing. Which of the following certificates will be issued wh...
• A POCT site is surveyed by an accreditation agency. The survey results in compliance. A certificate of registration will be issued to this facility.
• A test kit received by the laboratory has a EUA designation. Which of the following is a correct statement?
• Training Requirements for Point-of-Care Testing
• Training Requirements for POCT
• At the local hospital, the staff member responsible for training in laboratory testing methods was not on-site during the orientation for two emergenc...
• The educator for the laboratory is working with a group of new hires who will be performing POCT at different locations on a rotating basis. All locat...
• Training an employee on a new test method may be performed by any co-worker that performs a similar method.
• Competency Assessment Requirements for Point-of-Care Testing
• Competency Assessment for POCT
• In a recent survey, the laboratory manager was cited for not assessing all six required CLIA procedures. Which of the following is NOT a required CLIA...
• As per federal regulations, the technical consultant must assess competency for POCT for which of the following scenarios?
• The laboratory manager is developing a six-month and annual competency assessment for a new test method. Which of the following would not be a necessa...
• Personnel Requiring Competency Assessment
• Match the personnel to either competency assessment required or competency assessment not required.
• Which of the following personnel require annual competency assessment?
• Technical consultants are the only personnel that do NOT require competency assessment annually.
• Personnel Qualified to Perform Competency Assessment
• Choose the best tool for each competency being assessed.
• A new laboratory is being structured and job descriptions written. For compliance, the qualified laboratory director will perform competency assessmen...
• Procedure Manual Requirements for Point-of-Care Testing
• Procedure Manual Requirements
• A POCT location in the hospital performs only CLIA-waived testing. CLIA regulations do not require test procedures for testing personnel use.
• The point-of-care coordinator has organized a policy and procedure manual for POCT. Package inserts have been incorporated as procedures for some test...
• Match each statement related to point-of-care (POC) policy and procedure as compliant or non-compliant.
• Proficiency Testing Requirements for Point-of-Care Testing
• Proficiency Testing Requirements for Point of Care Testing
• A new laboratory has enrolled in a commercial proficiency program and has used this program for three months. A new, non-waived test is added to the m...
• Proficiency Testing Procedures
• The new POC manager is assigning proficiency job responsibilities at a remote testing location. He has assigned all PT to the general supervisor to co...
• A POC site is reviewing records in preparation for an inspection. Which of the following can be discarded?
• The laboratory is registering for annual proficiency testing. During the previous year, three new, non-waived POC methods have been added to the test ...
• Corrective Action for Proficiency Testing
• The laboratory supervisor is reviewing complete blood count (CBC) PT results. Which of the following results require corrective action?
• Match the following corrective action step with a specific activity included in the review.
• References
• References

Additional Information