Summary:
Summary Statement of Deficiencies D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Based on observation of the laboratory, patient test report review, and staff interview, the laboratory failed to provide instructions to clients that collect patient specimens to include patient preparation, specimen collection, specimen labeling, specimen storage, preservation, or conditions for transportation on the date of the survey (12/06/2023) for serum human chorionic gonadotropin (hCG) testing. The findings include: 1. Observation of the laboratory on 12/06/2023 at 10:00 am revealed an OSUM combo test kit in use for serum hCG patient testing. 2. Review of a patient test report revealed a serum hCG reported on 11/16/2023 for patient #C23016 that was collected from an outside client. 3. During an interview with the laboratory director on 12/06 /2023 at 10:30 am, the laboratory director was asked to provide a copy of instructions provided to the outside client(s) that included the requirements for patient preparation, specimen collection, specimen labeling, specimen storage, preservation, or conditions for trasnportation for the serum hCG patient testing. No document was available. This confirmed the survey findings. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --