Summary:
Summary Statement of Deficiencies 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 direct observation, review of humidity monitoring records, humidity manufacturer's requirements, review of Labcorp Technical Bulletin documentation, and interviews with the Facilities Manager and Quality Manager, the laboratory failed to set the humidity alarm limits in accordance with the manufacturer's required operating conditions for 7 out of 7 months reviewed (November 2025 June 2026) for the instrumentation in use. Findings: 1. On 06/17/2026 at approximately 9:30 AM, during a tour of the main laboratory room, the following analyzers were observed in use: - Roche Cobas (2) c 502, (6) c 701, (11) e 801 analyzers - All units carry a manufacturer-specified operating requirement of 30% - 85% relative humidity (RH). 2. On 06/18/2026 at approximately 10:00 AM, a review of the main laboratory room humidity records for November 2025 revealed the following: - From November 1 through November 12, 2025, the humidity alarm limits were set at 20% - 85% RH, with recorded humidity values falling below the 20% lower threshold. - On November 12, 2025, the low alarm limit was changed to 0% RH, establishing alarm limits of 0% - 85% RH, which remained in effect through the date of survey, 06/18/2026. 3. Review of Labcorp Technical Bulletin TB26-034 stated: "Roche Diagnostics informs Labcorp that, based on the results of recent studies, the cobas pro and cobas pure 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 -- integrated solutions can be operated safely down to an environmental relative humidity of 20%." 4. On 06/18/2026 at approximately 10:45 AM, an interview with the Facilities Manager and Quality Manager confirmed that the low humidity alarm limit has been set to 0% RH since 11/12/2025, which is outside the manufacturer's specified operating conditions. It was further stated that the facilities department is actively working to identify a solution for the low humidity conditions periodically experienced in the laboratory. D5805 TEST REPORT 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 final microbiology test reports and interview with the Technical Supervisor (TS #3), the laboratory failed to include the specimen source on 2 of 6 applicable microbiology test reports. Findings: 1. On 06/17/2026 at approximately 2: 30 PM, a review of six (6) microbiology final test reports was conducted. The review revealed that two (2) anaerobic and aerobic culture with sensitivity reports lacked documentation of the specimen source: - Specimen ID 103-861-0128-0, reported on 04 /17/2026 - Specimen ID 104-166-0347-0, reported on 04/18/2026 2. On 06/17/2026 at approximately 2:35 PM, an interview with TS #3 confirmed that the aforementioned test reports lacked the specimen source. TS #3 further stated that the specimen source must be manually entered as a comment in the laboratory information system (LIS) in order for it to appear on the final test report. -- 2 of 2 --