Dyersburg Family Walk-In Clinic, Llc

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 observation of the laboratory, review of the Sysmex XP 300 operator's manual, the laboratory's environmental records, patient test reports, staff interview, and follow-up electronic communication, the laboratory failed to monitor room temperature in the area where the Sysmex XP300 Complete Blood Count with automated White Blood Cell Differential (CBC w/Diff) instrument was used from 03 /01/24 to the date of the survey on 06/26/24. The findings include: 1. Observation of the laboratory on 06/26/24 at 8:15 a.m. revealed the Sysmex XP300 (serial number B6600) used for performing patient testing for CBC w/Diff. 2. A review of the Sysmex XP 300 operator's manual revealed that the instrument required a room temperature of 15 to 30 degrees Celsius during operation. 3. A review of environmental records revealed that room temperatures were not monitored from 03 /01/24 to 06/26/24 (the survey date). 4. A review of patient test reports revealed a CBC w/Diff reported on patient number three on 04/01/24. 5. The technical consultant confirmed the survey findings during an interview on 06/26/24 at 11:30 a.m. 6. The technical consultant stated during an electronic message received on 06/27/24 at 12:47 p.m. that 860 patient CBCs were reported from 03/01/24 to 06/26/24 (date of survey) during the period when room temperatures were not monitored. 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 -- D5461 CONTROL PROCEDURES CFR(s): 493.1256(d)(6)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Perform control material testing as specified in this paragraph before resuming patient testing when a complete change of reagents is introduced; major preventive maintenance is performed; or any critical part that may influence test performance is replaced. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on laboratory observation and staff interviews, the laboratory failed to perform quality control (QC) after changing reagents on the Sysmex XP 300 CBC instrument. The findings include: 1. Observation of the laboratory on 06/26/24 at 8:15 a.m. revealed the Sysmex XP300 (serial number B6600) used for performing patient testing for CBC w/Diff. During observation, testing person three was asked to describe the protocol for performing quality control. When asked if the laboratory performed QC after reagent changes, she stated they did not. 2. The technical consultant confirmed the survey findings during an interview on 06/26/24 at 11:30 a. m. -- 2 of 2 --

Summary Statement of Deficiencies D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D2005 ENROLLMENT CFR(s): 493.801(a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: Based on review of the 2017 and 2018 proficiency testing (PT) records, the Centers for Medicare and Medicaid Services (CMS), the ASPEN WEB CLIA 116 records and interview with technical consultant number one, the laboratory failed to ensure the PT program released results to Health and Human Services (HHS) using the correct CLIA number. The findings include: 1) Review of the 2017 and 2018 PT records revealed the incorrect CLIA number (44D1022379) was in use. 2) Review of the CMS 155 report for this laboratory revealed no scores for 2017 events one, two, three and 2018 event one. 3) Review of the ASPEN WEB CLIA 116 records revealed the following for CLIA number 44D1022379: expiration date 10-12-17 with Term Code 01 Voluntary-Merger, Closure 4) Interview on May 23, 2018 at 12:15 p.m. with technical consultant number one confirmed the incorrect CLIA number was in use for the PT agency. 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 --