Summary:
Summary Statement of Deficiencies D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based on review of the procedure manual and interview with the laboratory director (LD), the laboratory did not have a procedure for verifying the accuracy of the multiplex oral fluid SARS-CoV-2 IgG assay at least twice annually as required in 493.1236(c)(1). During the onsite survey on 12/14/2023 at 3:30 PM, the LD confirmed that there was no procedure to verify the accuracy of the multiplex oral fluid assay at least twice annually. 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 procedure manual and interview with the laboratory director (LD), the laboratory failed to provide a client service manual with written pre- Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- analytical instructions for clients to follow when collecting, storing, and submitting specimens for analysis. Findings: 1. Review of the policies and procedure manuals showed that the laboratory did not have written instructions available to their clients that included patient preparation, specimen collection, specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source, specimen storage and preservation, conditions for specimen transportation, specimen processing, specimen acceptability and rejection, specimen referral and how to maintain the patient log book at the offices. 2. During the survey on 12/14/2022 at 3: 30 PM the LD confirmed that the laboratory did not have written pre-analytical instructions available to their clients for the collection and transportation of the specimens to the reference laboratory. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)