Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on January 21, 2020. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 Policy and Procedure manual, and staff interview, the laboratory failed to have an acceptable Policy for labeling specimens collected in the facility, and failed to provide proper labeling on Urine samples. Findings: 1. During a tour of the laboratory, a urine specimen was observed sitting on the counter with only patient initials on the outside of the cup. Review of the policy for labeling specimens for fingerstick indicate that patients names only were required for labeling. No other labeling information was in the policy. 2. Interview with staff #3 (CMS 209), on January 21, 2020, at approximately 1:40 pm, in the storage room, confirmed the urine specimen sitting on the counter only had the patients name on the sample container. There was not a policy for labeling specimens with two unique identifiers, as required, in the policy and procedure manual. 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 --