Sherwood Urgent Care-Lonoke

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 review of manufacturer's instruction, temperature and humidity logs, and interview with staff, the laboratory failed to follow manufacturer's instructions for operational environment relative humidity for Sysmex XP-300. Findings follow: A) Review of the Sysmex XP-300 instrument manual (Automated Hematolgoy Analyzer XP Series XP-300 Instruction for Use (North American Edition), Code No. Au553517, rev. Feb 2013), revealed the operating environment for relative humidity is "30 to 85% ". B) Review of the laboratory humidity log revealed a target range of "20-80%." C) Review of the laboratory humidity log revealed humidity below 30% on 24 of 110 days of operation in January, February, March, and November of 2025. D) During an interview on 11/20/25 at 10:36 am the lab director confirmed the operation of the Sysmex XP-300 below 30% humidity and the incorrect range stated on the humidity log. 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 D5805 TEST REPORT CFR(s): 493.1291(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: Through a review of five final patient reports, Sysmex daily run logs and interview with laboratory staff it was determined that five of five results reviewed did not have the date received and did not have the reported date completed. Findings follow: A) Review of ten laboratory final reports revealed that five of five of the reports stated "Received: " and the "Reported: " section of the final report no documented received date/time and no documented reported date/time. B) Review of the Sysmex daily run logs revealed that five of five of the complete blood count (CBC) reports reviewed were completed the same day "Received: " and the "Reported: ". No documented date /time for the following CBC samples on the final report: Sample 30082 on 3/14/2022, Sample 66682 on 3/6/2023, Sample 53762 on 7/28/2023, Sample 52574 on 11/24 /2024, and Sample 20082 on 3/14/2024. C) In an interview on 3/14/2024 at 11:48 am, the laboratory directory on the CMS 209 form confirmed that the date and time were not documented on "Received: "section and the "Reported:" section on the final 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 1 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Through a review of the laboratory policy titled, "Error Flags for the Sysmex XP 300", instrument data logs for January through April 2022, and through interviews with laboratory staff, it was determined the laboratory failed to follow manufacturer's instructions for error flags generated by the complete blood count (CBC) instrumentation. Survey findings include: A. A review of the policy "Error Flags for the Sysmex XP 300" revealed that an AG flag is caused by "Presence of nucleated red blood cells, increase of large platelets, platelet aggregation or agglutination, precipitation of fibrin, presence of proteins or lipids, etc." and the manufacturer correction is listed as "Warm the Sample and repeat analysis". Other instructions listed in this policy state, "Above are the common flags and their causes generated by the Sysmex XP 300. When these flags are generated by the instrument: 1. Check the specimen for clots or agglutination. Recollect if clots are found!; 2. If no clots are detected, the specimen will be re-mixed and re-tested; 3. If flag persists, at the discretion of the physician, send the sample to the reference laboratory for a manual differential." B. The surveyor reviewed ten randomly selected patient test results listed on the instrument data logs for January through April 2022. Nine of ten patients selected had AG flags documented on the platelet portion of the CBC. Six of the nine flagged results had no documentation that the sample had been repeated or sent to the reference laboratory for a manual differential. C. In an interview, at 11:17 on 5/12 /2022 the laboratory director (as listed on the form CMS-209) confirmed the laboratory did not repeat the CBC testing on six of nine samples with flagged results. 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 D5805 TEST REPORT CFR(s): 493.1291(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: Through a review of eight Laboratory Results reports and interviews with laboratory personnel it was determined the laboratory test reports failed to include the address of the laboratory location where the test was performed. Survey findings include: A. Eight of eight patient Laboratory Results reports reviewed failed to include the address of the laboratory location where testing was performed. All eight reports for testing done in this laboratory (1306 North Cedar in Lonoke Arkansas) stated that the performing laboratory was located at 123 Audubon Drive in Maumelle Arkansas. B. In an interview at 11:15 on 2/27/2020 the laboratory director (as listed on the form CMS-209) confirmed the performing laboratory listed on the reports was not the laboratory that performed the testing on the samples. 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 --