Chilton Medical Associates

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 a review of the environmental records, policy and procedure records, and an interview with Testing Personnel #1 and #2, the Laboratory failed to ensure humidity in the room in which the Sysmex XP 300 Hematology analyzer was operated was within the manufacturer's acceptable limits. Humidity was noted below acceptable ranges for 15 days from 2023 to 2024. The findings include: 1. A review of the Sysmex XP 300 Hematology temperature records revealed Humidity was below the manufacturer's acceptable parameters (30-85%) for a total of 15 days as follows: a) 2023: 1/16, 3/20, 12/11, 12/20, 12/21 b) 2024: 1/2-1/5, 1/17, 1/18, 1/20, 12/2-12/4 2. A review of the Policies and Procedure manual and specifications of the CBC analyzer, Sysmex XP-300, revealed a proper relative Humidity during operation to be 30-85%. 3. During the exit conference on March 11, 2025, at 1:30 PM, Testing Personnel #1 and #2 confirmed the above findings. 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 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 -- specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of the Hematology Sysmex XP-300 maintenance records, a review of the Sysmex XP-300 Instructions for Use, and an interview with the Testing Personnel (TP) 1 and 2, the laboratory failed to perform the analyzer's quarterly maintenance. The surveyor noted three out of six quarterly maintenances had no documentation from 2023-2024. The findings include: 1. A review of the Hematology maintenance records revealed a place to document quarterly (every 3 months) maintenance on the Sysmex XP-300 Maintenance Log, but the only documentation of performance was from the Sysmex Service Engineer when the preventive maintenance was performed. 2. A review of the Sysmex XP-300 Instructions for Use revealed in section 12 page 12-12 under Clean SRV "... if either the counter value exceeds 4,500, or if 3 months have passed since the last maintenance, a message will appear prompting the operator to perform periodic maintenance (SRV cleaning) ..." 3. During the exit conference on 03-11-2025 at 1:30 PM, the TP #1 and #2 confirmed the above findings. They both agreed quarterly maintenance was not performed by the TP because they did not know where the procedure can be found and was never trained on how to do it. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the Accutest proficiency testing records and an interview with Testing Personnel (TP) #2 (Laboratory Supervisor), the surveyor determined the testing personnel and/or the Laboratory Director (LD) failed to sign the attestation statement for each testing event in 2018 - 2020. This affected 14 of 16 events, reviewed by the surveyor. The finding include: 1. The following attestation statements for Hematology and Microscopy proficiency testing were not signed by the Laboratory Director (LD) and/or the testing personnel: a) Hematology Event #2, 2018 (no signature by LD); Microscopy Event #2, 2018 (no signature by LD nor TP). b) Hematology Event #3, 2018 (no signature by LD nor TP) c) Hematology Event #1, 2019 (no signature by LD nor TP); Microscopy Event #1 2019 (not signed by TP) d) Hematology Event #2, 2019 (no LD signature); Microscopy Event #2 2019 (not signed by the TP) e) Hematology Event #3, 2019 (no signature by LD nor TP) f) Hematology Event #1, 2020 and Microscopy Event #1, 2020 (no signature by LD) g) Hematology Event #2, 2020 and Microscopy Event #2, 2020 (no signature by LD) h) Hematology Event #3, 2020 and Microscopy Event #3, 2020 (no signature by LD) 2. In an interview on April 13, 2021 at 10:58 AM, TP # 2 confirmed the above noted findings. At 1:30 PM, during the exit interview, proficiency testing requirements were discussed with TP #2 (Laboratory Supervisor) and the Office Manager. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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 -- The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of personnel records, policy and procedure manual, and interview with Testing Personnel (TP) #1, the surveyor determined that the Technical Consultant (TC) failed to performed a semi-annual evaluation during the first year of employment for one of three TP. The findings include: 1. A review of the personnel records revealed there was no documentation of a semi-annual evaluation performed for TP #1, who was originally hired on 7/17/2017 and intially trained on 10/2/2017. 2. The policy entitled " Personnel Assessment" states "...The evaluations, which are based on job descriptions, should be done between the third, sixth, and twelfth month following initial employment and annually thereafter. ... ." 3. In an interview on 07/05 /2018 at 9:48 AM, TP #1 confirmed she did not have an semi-annual evaluation performed. Jeremy Westry, BS, MT (ASCP) Licensure and Certification Surveyor 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 --