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- 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.
Level of instruction: Basic
Intended audience: Medical laboratory scientists, medical technologists, and technicians. This course is also appropriate for medical laboratory science students and pathology residents.
Author information: Sheryl A. Whitlock, MA.Ed, MT(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 to include management, education, and hands-on bench experience. She has written and published textbooks and laboratory manuals as well as having contributed to numerous online and print articles in the field of laboratory medicine.
Reviewer information: Cynthia Clawson, BSMT(ASCP), MBA, HCA received her Masters degree from Wilmington College, in Wilmington Delaware and a Bachelor of Science degree in medical technology from Salisbury State University in Salisbury, Maryland. She began her career as a bench technologist at then Kent and Queen Anne’s Hospital in Chestertown, Maryland. Currently, she is a Clinical Specialist for Point-of-Care testing, Quality Assurance, and Regulatory Compliance at the same facility, now called the University of Maryland Shore Regional Health at Chestertown.
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.