Summary:
Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's specimen labeling discrepancy records, and interview with the laboratory testing person on February 26, 2025, at 12:00 pm, the laboratory failed to label specimen correctly during the collection and subsequent processing. The findings include: 1. The laboratory received GI biopsy specimen from its surgery center next door. In many instances, the laboratory switched the specimen labeling due to possible mislabel during collection. For example, on 11/19/2024, the laboratory switched the labeling bottle 1 to 2; on 11/25/2024, the laboratory switched the labeling bottle 4 to 5; on 11/27/2024, the laboratory switched the labeling bottle 1 to 2. The testing person said that the reason for switching the bottle label was mismatch of writing on the bottle cap and the body, and the switching was done after discussion with the specimen collection staff. Although, sometime mislabeled specimen can be correctly identified by a pathologist at microscopic observation due to the tissue architecture, tissue taken from proximity would be difficult. Therefore, the accuracy of the specimen labeling and patients' test results rendered by the laboratory cannot be assured and may have harmed patient. 2. The laboratory testing person on February 26, 2025, at 12:00 pm, affirmed that the laboratory switched the specimen labeling on many occasions. 3. The laboratory's testing declaration form, signed by the laboratory director on 2/3/2025, stated that the laboratory performed approximately 9,000 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 3 -- D5393 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(b)(c) (b) The preanalytic systems assessment must include a review of the effectiveness of