Maintaining Compliance with Point-of-Care Testing

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Author: Sheryl A. Whitlock, MA.Ed, MLS(ASCP)BB
Reviewer: Laurie Bjerklie, MA, MLS(ASCP)CM

This course will differentiate between the terms point-of-care testing (POCT) and waived testing, which is instrumental for the proper application of regulations needed to ensure compliance with state and federal requirements and accreditation regulations. It will outline the necessary components that must be in place to ensure POCT compliance, including specific requirements for POCT policies and procedures, staff training, competency testing, and proficiency testing.

Continuing Education Credits

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
      • Emergency Use Authorization
      • A children's hospital has urine chemistry testing in four locations. Which of the following locations qualify as POCT sites?
      • True or False: All POCT is waived, but not all waived testing is 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...
      • True or False: An accreditation agency surveys a POCT site. The survey results in compliance, and this facility will receive a certificate of registra...
      • A test kit received by the laboratory has an 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 laboratory educator is working with a group of new hires who will perform POCT at different locations on a rotating basis. All locations do not us...
      • True or False: Training an employee on a new test method may be performed by any co-worker who performs a similar method.
  • Competency Assessment Requirements for Point-of-Care Testing
      • Competency Assessment for POCT
      • Competency Assessment Requirements
      • 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.
      • True or False: Technical consultants are the only personnel who 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 are being written. For compliance, the qualified laboratory director will perform competenc...
  • Procedure Manual Requirements for Point-of-Care Testing
      • Procedure Manual Requirements
      • True or False: A POCT location in the hospital performs only CLIA-waived testing. CLIA regulations do not require test procedures for testing personne...
      • 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
      • A new laboratory has enrolled in a commercial proficiency program and has used it for three months. A new, non-waived test has been added to the menu,...
      • 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 were added to the test menu ...
      • Corrective Action for Proficiency Testing
      • The laboratory supervisor is reviewing complete blood count (CBC) PT results. Which of the following results requires corrective action?
      • Match the following corrective action step with a specific activity included in the review.
  • References
      • References

Additional Information

Level of Instruction: Basic
Intended Audience: This course is designed for point-of-care testing personnel, coordinators, medical laboratory scientists, medical laboratory technicians, laboratory supervisors, and laboratory managers. It is also appropriate for MLS and MLT students and pathology residents.
Author Information: Sheryl A. Whitlock, MA.Ed, MLS(ASCP)BB, is the owner of ARK Laboratory Consulting, LLC, and a part-time technical consultant for McKesson. Sheryl served as the laboratory coordinator for the Student Health Services Laboratory at the University of Delaware for 15 years. Sheryl received her Master’s degree in Education from Arcadia University in Glenside, Pennsylvania. She has more than 35 years of experience in laboratory science, including management, education, and hands-on bench experience. She has written and published textbooks and laboratory manuals, as well as contributed to numerous online and print articles in the field of laboratory medicine.
The author has no conflict of interest to disclose.
Reviewer Information: Laurie Bjerklie, MA, MLS(ASCP)CM, is a Lead Education Developer. She earned a B.S. in Medical Laboratory Science from the University of North Dakota and an M.A. in Curriculum and Instruction from Saint Xavier University. She has over 15 years of experience in higher education and has held program director and faculty positions in both MLT and MLS programs.
Course Description: This course will differentiate between the terms point-of-care testing (POCT) and waived testing, which is instrumental for the proper application of regulations needed to ensure compliance with state and federal requirements and accreditation regulations. It will outline the necessary components that must be in place to ensure POCT compliance, including specific requirements for POCT policies and procedures, staff training, competency testing, and proficiency testing.

This course is part of:
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