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 review of the ThinPrep Pap Test PreservCyt Solution Manufacturer's Instructions (TPMI), review of the laboratory's Specimen Collection Policy and Shipment Logs, lack of documentation, and interview with the General Supervisor (GS), the laboratory failed to follow temperature requirements for Gynecological Cytology samples during March through May 2025. Findings include: 1. Review of the TPMI indicated specimens are stable between 15 Celcius (C) and 30 C. 2. Review of the laboratory's Specimen Collection Policy did not indicate transport temperature storage requirements for gynecological samples. 3. A review of the laboratory's Shipment Logs indicated gynecological samples are shipped to the laboratory from separate locations. 4. The laboratory failed to provide requested documentation demonstrating temperature requirements for gynecological samples are maintained during transit. 5. During an interview with the GS on 8/20/2025 at 12:21 pm, the GS indicated that the laboratory does not monitor sample temperatures during transit or upon receipt. 6. The laboratory reported 4858 Gynecological Cytology tests transported from separate locations in March through May 2025. 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 --