Policy Manual sample

MDT Home Health Care Agency, Inc. LABORATORY TESTING: CLIA WAIVER POLICY: Laboratory specimens obtained by Agency staff will be referred to a certified facility for those services. A certificate of waiver will be maintained by Agency for laboratory specimen collection and analysis done in the home setting with equipment owned by the agency, client, or a staff member. Agency nursing staff will perform only waived testing procedures that meet Clinical Laboratory Improvement Amendment of 1988 (CLIA88) Requirements. Tests performed by agency nursing staff will be for screening purposes only. Laboratory services. (1) If our HHA engages in laboratory testing outside of the context of assisting an individual in self - administering a test with an appliance that has been cleared for that purpose by the Food and Drug Administration, the testing must be in compliance with all applicable requirements. Our HHA will not substitute its equipment for a patient’s equipment when assisting with self - administered tests. (2) If our HHA refers specimens for laboratory testing, the referral laboratory must be certified in the appropriate specialties and subspecialties of services in accordance with the applicable requirements. PURPOSE To ensure compliance with federal and state regulations concerning laboratory testing outside the context of assisting an individual in self-administering a test. To ensure agency nursing staff who performed waived testing are qualified. To ensure that waived tests are performed accurately and appropriately. SPECIAL INSTRUCTIONS 1. Waived tests are simple, stable, and require a minimal degree of judgement and interpretation. 2. Agency will identify when waived tests are to be completed by agency nursing personnel and which nursing personnel may provide each test. 3. Agency will provide training to agency nursing personnel performing waived tests and determine clinical competencies for those tests. Also will be instructed in the frequency of conducting equipment calibration, cleaning, testing and maintenance, and Quality Control Procedures. 4. The use of equipment in the performance of conducting waived tests include: • Instructions for using the equipment • The frequency of conducting equipment calibration, cleaning, testing and maintenance • Quality control procedures These items should be addressed for each piece of equipment nursing staff use to perform waived testing, for example: glucometers, PTI/NR, etc. 5. Only tests on waived list may be performed by agency nursing personnel. These tests include those listed here. (A complete list is maintained by CDC and changes rapidly). This complete list can be found on the internet at: www.phppo.cdc.gov/dis/clia/waived.htm NOTE: Bold cap print represents tests performed by the agency at this time a. Dipstick or tablet reagent urinalysis (non-automated) for: • Bilirubin Home Health Agency Policies A-157