Summary:
Summary Statement of Deficiencies D0000 An onsite validation survey was conducted on 03/05/2026, and standard level deficiencies were cited. 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 an interview with staff, and a review of the laboratory's policies and procedures, the laboratory failed to establish policies and procedures for the proper storage and transport of specimens for two of two years (2024-2025). a. An interview with the Associate Vice President of Clinical Services on 03/05/206 at 11:59 AM, in the conference room, revealed that specimens are collected from across the state and transported to the laboratory via courier for deceased donor ABO and HLA phenotyping testing. b. The laboratory was asked to provide policies and procedures for the storage and transport of specimens. No documentation was provided. c. An interview with the Laboratory Director, the General Supervisor, and the Associate Vice President of Clinical Services on 03/05/2026 at 3:45 PM, in the conference room, confirmed the findings. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: I. Based on direct observation, manufacturers' instructions, the laboratory's documentation, and interviews with staff, the laboratory failed to define acceptable humidity ranges and to monitor and document humidity according to the manufacturers' instructions for two years (2024-2025). a. A tour of the laboratory at 10:26 AM revealed 1 Qiagen EZ1 Advanced XL in the pre-amplification room and two QuantStudios instruments in the post-amplification room. b. A review of the manufacturers' instructions revealed: "EZ1 Advanced XL User Manual", November 2017, page 90, Appendix A, "Operating conditions ...Relative humidity 15-17% (noncondensing)"; and "QuantStudio 6 and 7 Flex Real-Time PCR Systems User Guide", Revision: B, page 168, "Environmental requirements ...Humidity 15-80% (noncondensing)". c. The laboratory was asked to provide documentation it defined and monitored humidity ranges. No documentation was provided. d. An interview with the Laboratory Director, the General Supervisor, and the Associate Vice President of Clinical Services on 03/05/2026 at 3:45 PM in the conference room confirmed that the laboratory did not define acceptable humidity ranges or monitor and document laboratory humidity. II. Based on a review of the laboratory's procedure, temperature records, and interviews with staff, the laboratory failed to define an acceptable temperature range for buffy coat storage for three of three months. a. A review of the laboratory's procedure DP-IGTP406.14 "DNA Isolation- Automated Robot", page 1, "2. Specimen Collection: ...The buffy coat can be stored at 4[degrees Celsius] for up to 7 days." The procedure did not define an acceptable temperature range. b. A review of the temperature records from 12/01/2025 to 03/05 /2026 for the refrigerator where buffy coat is stored revealed the temperature was approximately 10 [degrees Celsius], refer to D5785. c. An interview with the Laboratory Director, the General Supervisor, and the Associate Vice President of Clinical Services on 03/05/2026 at 3:45 PM, in the conference room, confirmed the findings. D5781