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 direct observation as well as interview with Processing Personnel (PP), the laboratory failed to ensure urine specimens were labeled with distinct identifying indicators including patient name or unique identifier to distinguish between specimens. FINDINGS: 1. The PP informed the surveyor that patient urine specimen containers were labelled in ink with patient's first name, last initial, and no other unique identifiers. Urine specimen containers were subsequently decanted into Aptima tubes featuring a printed label including unique patient identifiers. 2. It was observed that urine container label patient information was smudged or illegible for several of the specimens and the patient's name could not be positively identified. 3. The PP confirmed the findings on February 25th, 2025, at 12:00 P.M. D5393 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(b)(c) (b) The preanalytic systems assessment must include a review of the effectiveness of