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 observation of the laboratory, review of the laboratory's policy, and staff interviews, the laboratory failed to follow its policy for specimen labeling (one of one patient's urine specimen) on the survey date (01.16.2025). The findings include: 1. Observation of the laboratory on 01.16.2025 at 9:50 a.m. revealed one patient's urine specimen on the counter containing no identifying and collection information. 2. A review of the laboratory's policy titled "Specimen Collection" revealed the following statement, "All specimens will be labeled with the patient's name, medical record number or date of birth, along with the date and time of collection." 3. An interview with the technical consultant and lead testing person on 01.16.2025 at 9:55 a.m. confirmed the above survey findings. 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 --