Summary:
Summary Statement of Deficiencies 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 a review of laboratory policies and procedures, a direct observation of patient samples and an interview with the laboratory manager on 7/12/2022 the laboratory failed to label two specimen blood tubes to include patient name or unique patient identification. The findings include: 1. The laboratory procedure, "Specimen Labeling and Transporting Procedure" established that specimens must be labeled with two patient identifiers and the collector must initial and put the date and time of collection on the patient specimen. 2. A direct observation during the laboratory tour identified one K2 EDTA specimen tube and one Lithium Heparin specimen tube on the tube rocker that were labeled with only the patient date of birth. 3. The laboratory failed to follow their policy and label the patient specimen blood tubes with two identifiers, collectors initials and date and time of collection. 4. An interview with the laboratory manager on 7/12/2022 at 2:50 pm confirmed that the laboratory failed to label specimens to ensure positive patient identification, following the laboratory procedure. 5. The laboratory reports performing 2300 tests annually. 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 --