Baptist Eastpoint-Clinical Laboratory

Summary Statement of Deficiencies D0000 A recertification survey was conducted on 03/14/2023 and the facility was found not to be in substantial compliance with the laboratory requirements at 42 CFR Part 493, with deficiencies cited. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, proficiency testing documents, personnel documentation and interview, the laboratory failed to ensure testing personnel, who routinely performed Hematology and Chemistry testing in the laboratory, routinely processed proficiency testing (PT) samples for 6 of 6 events for 2021 and 2022. The findings include: Review of the laboratory's policy titled, "Proficiency Testing," signed by the Laboratory Director (LD) and dated 05/10/2020, specified, "2. Receive proficiency samples and insurers they are performed with the regular workload, rotated through personnel on all shifts and tested in the same manner as patient testing." Review of the PT records for Hematology and Chemistry events for 2021 and 2022, revealed Testing Personnel (TP) #2 performed the PT for all Hematology and Chemistry events for 2021 and 2022. Review of the "Annual Competency" forms and the "Job Specific Competencies/Skills Tracking Record (CTR)" for TP #1, #3, and #4, revealed they were assessed for their competency to perform Hematology and Chemistry testing in 2021 and 2022. During an interview on 03/14/2023 at 3:10 PM, TP #2 stated three (3) additional individuals, TP #1, #3, and #4, routinely performed patient testing in Hematology and Chemistry, but did not participate in PT. During an interview on 03/14/2023 at 3:50 PM, the General Supervisor confirmed TP #2 performed all PT for Hematology and Chemistry tests for 2021 and 2022. 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 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. This STANDARD is not met as evidenced by: Based on staff interview and record review on 07/26/2018, the facility failed to monitor and document the percent humidity for the laboratory where the testing was performed. Percent humidity was not recorded from July 8, 2016, through July 25, 2018. Findings include: Review of the Manufacturer's Operation Manuals for the Sysmex XN 1000 Hematology Analyzer and Roche Cobas Chemistry Analyzer revealed the operating range for percent humidity should be between thirty percent (30%) and eighty-five percent (85%). Review of the Maintenance Log, revealed there was no documented evidence the percent humidity had been monitored from September 29, 2016, through August 15, 2018. Testing personnel acknowledged in an interview on 08/16/2018 at 12:35 PM, the laboratory failed to have a system in place to ensure the percent humidity was monitored and documented daily in accordance with manufacturer's recommendation for the Sysmex XN 1000 Hematology Analyzer and Roche Cobas Chemistry Analyzer. 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 --