Summary:
Summary Statement of Deficiencies D0000 The Central Plains Laboratories, DBA Quest Diagnostics was found in compliance with 42 CFR Part 493 requirements for laboratories as a result of a validation survey on 04/02/26. Standard level deficiencies cited. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for 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: Based on laboratory's written procedure, environmental records, and interview with the Director of Laboratory Operations, the laboratory failed to ensure room temperature followed the laboratory's written procedure for one of one month. Findings included: 1. A review of the laboratory's written procedure titled, "Policy for Temperature/Humidity Monitoring" stated, "3. When the manufacturer states to store or run at Room Temperature, the acceptable range is 20 to 25C based on CLSI guidance." 2. A review of the laboratory's room temperature records for October 2025 revealed the laboratory's acceptable room temperature of 19-25C, exceeding the lower limits of the laboratory's own written procedure. 3. In an interview on 04/02/26 at 2: 15 pm, the Director of Laboratory Operations, confirmed the findings above. Word key CLSI = Clinical & Laboratory Standards Institute D5805 TEST REPORT Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of a patient test report and interview with the Director of Laboratory Operations, the laboratory failed to ensure a patient test report included the full address of the laboratory's location for one of one patient. Findings included: 1. On 04 /01/26 at 10:00 am, during the laboratory tour, the Director of Laboratory Operations, confirmed the laboratory performed Histopathology, Oral Pathology, and Cytology testing. 2. A review of one patient report (patient V00073977761) revealed the address of the performing site as "2220 CANTERBURY, HAYS, KS 67601-2296", which did not match the address on the CLIA certificate (2220 Canterbury Drive, Hays, KS 67601-2296). 3. Interview on 04/01/26 at 10:55 am with the Director of Laboratory Operations, confirmed the patient test report did not include the laboratory's full address. -- 2 of 2 --