Summary:
Summary Statement of Deficiencies D0000 Based on a CLIA recertification survey performed on April 05, 2021 this facility was found to be in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual and interviews with the laboratory Coordinator and center manager, the laboratory failed to have a written protocol for sending specimens to outside reference laboratories for testing. The findings include: 1. The laboratory's procedure manual did not have a written policy and procedure (to include collection, preservation, storage, pick-up times and transport schedules) for staff to follow when sending specimens to reference laboratories (LabCorp, Quest, and Wellstar Health System) from June 2020 to April 2021. 2. Interviews with the laboratory Coordinator and center manager on 4/5/2021 at approximately 12:40 pm in the break room confirmed that the laboratory did not have a written protocol for staff to follow when sending specimens to a reference laboratories from June 2020 to April 2021. 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 --