Atmore Urgent Care

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 reviews of the environmental logs, Sysmex XN-330 operator's manual, and an interview the Technical Consultant (TC), the laboratory failed to record the Room Temperature (RT) and Humidity in the room where the analyzer was operated were within the manufacturer's acceptable limits. The surveyor noted no documentation of the RT and Humidity for 2 out of the 12 months in 2023. The findings include: 1. A review of the environmental logs revealed the June-July 2023 RT and Humidity records were missing during the survey. 2. A review of the Sysmex XN-330 General Information Manual revealed the manufacturer's operating environment requirements on Chapter 5 to be: A) Ambient temperature: 15-35 degrees Celsius B) Relative Humidity: 20-85 percent 3. The TC confirmed the above findings during the exit conference on 04-30-2025 at 2:30 PM. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. 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 -- This STANDARD is not met as evidenced by: Based on a review of the Hematology maintenance logs for the Sysmex XN-300, and an interview with the Technical Consultant (TC), the laboratory failed to perform and document the analyzer's required maintenance. The surveyor noted maintenance documenattion were missing for 2 of the 12 months in 2023. The findings include: 1. A review of the Sysmex XN-300 maintenance logs revealed the daily, weekly, and as needed maintenance were not performed and documented from June-July 2023. 2. The TC confirmed the above findings during the exit conference on 04-30-2025 at 2: 30 PM. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) (a )Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (a)(1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (a)(2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (a)(2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (a) (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (a)(3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on reviews of the Hematology calibration records, laboratory's policy and procedure manual for the Sysmex XN-300 analyzer and an interview with the Technical Consultant (TC), the laboratory failed to perform calibration at least every six months. This was noted for three of the four possible calibrations from 2023-2025. The findings include: 1. A review of the Hematology calibration records revealed the Sysmex XN-300 was not calibrated according to the laboratory's established policy of at least every six months. Laboratory's calibration records revealed the following: A) The calibration due on 02-21-2023 was not performed and completed until 5-10- 2023, approximately three months later. B) The calibration due on 11-08-2023 was not performed and completed until 1-18- 2024, approximately two months later. C) The calibration due on 07-18-2024 was not performed and completed until 1-15- 2025, approximately six months later. 2. The TC confirmed the above findings on 04- 30-2025 at 2:30 PM during the exit conference. -- 2 of 2 --

Summary Statement of Deficiencies D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a review of Proficiency Testing (PT) records and an interview with the Technical Consultant, the laboratory failed to attain a score of at least 80% for each analyte submitted for Hematology 1st Event 2023. This was noted for one out of one Proficiency Testing event reviewed. The finding include: 1. A review of the American Proficiency Institute (API) PT records revealed the following failing scores for analytes on the Hematology 1st Event 2023 survey: a) Leukocyte Count - 0% b) White Blood Cell Differential - 7% 2. The surveyor further noted calculated indices for the RBC's (Red Blood Cells) also yielded failing scores, as follows: a) Mean Corpuscular Hemoglobin Concentration (MCHC) - 20% b) Mean Corpuscular Volume (MCV) - 40% c) Red Cell Distribution Width (RDW) - 0% 3. During an interview on 4/25/2023 at 11:00 AM, the Technical Consultant explained the laboratory received the failing scores due to enrollment in the wrong Proficiency Testing program for their Hematology instrument. 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- Based on a review of the Policies and Procedures and an interview with the Technical Consultant, the laboratory failed to establish and follow written policies and procedures to assess the competency of employees. This was noted from the implementation of the Policy and Procedure Manual, 8/30/2022, to the date of the current survey, 4/25/2023. The findings include: 1. A review of the Policies and Procedures revealed no procedure on performance of competency assessments for testing personnel. 2. During an interview on 4/25/2023 at 12:30 PM, the Technical Consultant confirmed no other policies were available to review. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on a review of Policies and Procedures and an interview with the Technical Consultant, the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems. This was noted from the implementation of the Policy and Procedure Manual, 8/30/2022, to the date of the current survey, 4/25/2023. The findings include: 1. A review of Policies and Procedures revealed no evidence of a Quality Assurance plan for the facility. 2. During an interview on 4/25/2023 at 12:30 PM, the Technical Consultant confirmed the above findings. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)