Maintaining Compliance with Point-of-Care Testing
Continuing Education Credits
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.
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 requirements?
- 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 while awaiting a survey by the state CLIA compliance office?
- True or False: An accreditation agency surveys a POCT site. The survey results in compliance, and this facility will receive a certificate of registration.
- 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 emergency department (ED) personnel. These persons would be performing POCT as part of their daily job requirements. While training on ED protocols, the medical resident requested that a rapid strep test be performed on a patient. One of the new hires had pe
- 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 use the same brands of test kits. Since the group is large, the educator observes each employee testing with only one of the four different types of test kits used for testing at the remote locations. Following the completion of one test, each employee
- 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 assessment procedure?
- 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 necessary component of the assessment process?
- 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 competency assessments of all employees. Personnel who meet the minimum requirements for which of the following positions may also perform competency assessments for moderately complex testing as a job duty?
- 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 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 methods. Which of the following represents compliant use of package inserts?
- 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, and the laboratory must address proficiency testing (PT). The commercial program does not have PT for one analyte. Which of the following is an appropriate action for PT compliance in this situation?
- 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 complete. How do the assigned tasks align with regulatory requirements?
- 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 for POCT locations. Which of the following represents compliant practices reflective of federal guidelines?
- 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.