Policy Manual sample

MDT Home Health Care Agency, Inc. CERTIFICATE OF WAIVER CLIA (WAIVED TEST) Policy MDT Home Health Care Agency, Inc. shall file application, submit fees for a 'Certificate of Waiver'' every two years for performing only those laboratory examinations or procedure that have been recognized as waived tests by DHHS under Section 353(d)(3) Public Health Services Act. Purpose MDT Home Health Care Agency, Inc. must meet the requirements of Federal Public Law 100-578, Clinical Laboratory Improvement Amendments of 1988 (CLIA 1988). CLIA 1988 applies to all agencies with laboratories that examine human specimens for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. MDT Home Health Care Agency, Inc. may accept human specimens for the purpose of performing only those laboratory examinations or procedures that have been recognized as waived test by the Department of Health and Human Services (DHHS) under Section 535 (d)(3) of the Public Health Service Act. MDT Home Health Care Agency, Inc. maintains a current effective certificate issued by DHHS Health Service Care Financing Administration CLIA ID# . The certificate shall be renewed every two years. Procedure 1. The Certificate of Waiver allows the agency to participate in local health fairs or screening clinics offered to the general public; however, this only applies to glucose measuring devices and not to cholesterol screening at public fairs or clinics, then a higher level of complexity testing certificate must be applied for an all quality assurance (proficiency testing) and proper personnel requirements must be met. 2. A photocopy of the completed application requesting a Certificate of Waiver is maintained on file. Home Health Agency. - - Personnel/Operations Policies B-92