Tryon Medical Partners Central Labortaory

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of laboratory policy, review of laboratory personnel competency assessment records and interview with compliance team 11/20/24, the laboratory competency policy failed to include the frequency and method for performing general supervisor (GS) competency assessments and the laboratory failed to perform GS competency assessments since March of 2020 when testing personnel (TP) #3 was delegated as the GS, approximately 3 years and 6 months in which a GS competency assessment was not performed. Findings: Review of laboratory policy "Training and Competency Assessment" revealed the policy failed to include the frequency and method for performing GS competency assessments. Review of laboratory personnel competency assessment records revealed a delegation of duties for TP #3 for their role as GS signed in March of 2020. The records included competency for TP #3 for their role as testing personnel, but failed to include competency assessments for the duties delegated as GS since March of 2020. Interview with compliance team during exit interview at approximately 3:30 p.m. confirmed the laboratory policy failed to include the frequency and method for performing GS competency assessments. The team also confirmed their was no competency assessment performed for TP #3 for the duties delegated as GS since March of 2020. 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 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of 2019, 2020, 2021, and 2022 hematology records, the absence of records, and interview with TP #4 3/23/22, the laboratory failed to retain daily background counts for the Sysmex XN-2000 hematology analyzers from 3/9/20 to 1 /26/21, a period of approximately 10 months. Findings: Review of hematology records revealed the Sysmex XN-2000 hematology analyzers were installed 11/15/19, and patient testing began 3/9/20. Review of hematology records revealed there were no background counts prior to 1/27/21 available for review. During interview at approximately 2:55 p.m., TP #4 stated that since 1/27/21, backgrounds have been backed up to a USB drive. She confirmed that there were no daily background counts available for the 10 month period 3/9/20 to 1/26/21. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, review of 2020 and 2021 temperature and humidity logs, absence of documentation, and review of temperature