Fulton County Medical Center

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 review of the American Proficiency Institute (API) proficiency testing (PT) records and interview with the Technical Consultant (TC), the Laboratory Director (LD) failed to sign 1 of 8 API PT attestation statements for Blood Gas testing performed from 5/8/2023 to 6/25/2025. 1. The API PT instructions stated, "For all PT results, an attestation statement must be signed by testing personnel and the laboratory director and retained for a minimum of 2 years." 2. On the day of the survey, 6/25 /2025 at 10:30 am, the laboratory failed to provide an attestation statement signed by the LD/designee for 1 of 8 API Chem Core PT Events (API 3-2023) performed from 5 /8/2023 to 6/25/2025. 3. The TC confirmed the findings above on 6/25/2025 at 11:30 am. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on observation in the laboratory, lack of documentation, and interview with the Technical Consultant (TC), the laboratory failed to monitor the humidity of the blood gas laboratory to ensure proper operating conditions were met for 1 of 1 Werfen GEM 5000 blood gas analyzer used for chemistry testing from 8/5/2023 to 6/25/2025. Findings include: 1. On the day of survey, 4/14/2025, at 10:00 am, review of the laboratory's GEM Premier 5000 Requirements procedure stated: "GEM Premier 5000 machine: Relative Humidity - 15% to 85%." 2. The laboratory failed to provide documentation of humidity monitoring for 1 of 1 Werfen GEM 5000 blood gas analyzer from 8/5/2023 to 6/25/2025. 3. The laboratory performed 348 blood gas examinations in 2024 (CMS 116 estimated annual volume). 4. The TC confirmed the findings above on 6/25/2025 at 12:30 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. This STANDARD is not met as evidenced by: Based on observation of the laboratory, lack of documentation, and interview with the Technical Consultant (TC), the laboratory failed to perform and document the maintenance and function checks as defined by the manufacturer for 1 of 1 Traceable thermometer used for monitoring refrigerator temperatures in the Blood Gas laboratory from 08/5/2023 to 6/25/2025. Findings include: 1. On the day of the survey, 06/25/2025 at 12:30 pm, observation of the laboratory revealed the following thermometer used for refrigerator temperature monitoring in the Blood Gas laboratory was due for maintenance: - 1 of 1 Traceable Thermometer (S/N 160145507) due 1/22 /2018. 2. The laboratory failed to provide maintenance/functions checks records for the Traceable thermometer from 08/5/2023 to 06/25/2025. 3. The laboratory performed 348 blood gas examinations in 2024 (CMS 116, estimated annual volume). 4. The TC confirmed the findings above on 06/25/2025 at 12:30 pm. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to-- This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the Technical Consultant (TC), the TC failed to assess the competency of 5 of 13 testing personnel (TP) that performed blood gas examinations on the Werfen Gem Premier 5000 analyzer from 8 /5/2023 to 6/25/2025. Findings include: 1. On the day of survey, 6/55/2025 at 11:30 am, the laboratory failed to provide competency assessment records for the following 5 of 13 TP (CMS 209 TP #7-10 and 12) that performed blood gas analyses from 8/5 /2023 to the date of the survey: -TP #7 missing initial competency -TP #8 missing -- 2 of 3 -- 2023 and 2024 annual competency -TP #9 missing 2024 and 2025 annual competency -TP #10 missing 2023 annual competency -TP # 12 missing 2024 annual competency 2. The laboratory performed 348 blood gas analyses in 2024 (CMS 116, estimated annual volume). 3. The TC confirmed the findings above on 6/55/2025 at 1:30 pm. -- 3 of 3 --

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory procedures and interview with Testing Personnel (TP #1) ,the laboratory failed to ensure that the 1 of 1 laboratory procedure manual in use for the GEM Premier 5000 blood gas analyzer was approved, signed and dated by the current laboratory director (LD) from 06/22/2021 to 05/08/2023. Findings include: 1.The laboratory procedure manual in use for the GEM Premier 5000 blood gas analyzer reviewed at the time of inspection on 05/08/2023 at 11:45am, revealed the procedures were not approved,signed and dated by the current LD. 2. The laboratory's annual volume for Routine Chemistry is 307 (CMS-116). 3. TP #1 confirmed the above findings on 05/08/2023 around 11:50am. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of the Laboratory Personnel Report (CMS-209), the laboratory's competency assessment records and interview with Testing Personnel (TP #1), the Technical Consultant (TC) failed to evaluate the competency of 10 of 14 testing personnel in 2022 and 9 of 14 testing personnel in 2023. Findings include: 1. Based 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 -- on review of CMS-209 and the laboratory's competency assessment records on 05/08 /2023 at 11:20 a.m, the TC failed to evaluate the competency of 10 of 14 testing personnel in 2022 and 9 of 14 testing personnel in 2023. a. TP #1 who is not qualified under 493.1411 performed the competency assessment of 7 of 14 testing personnel in 2022 (CMS 209 TP#2,#4,#6, #9,#11, #13, and #14) and 8 of 14 testing personnel in 2023 (CMS 209 TP#3,#4,#5,#6,#7,#9,#10, and #12). b. TP #2 who is not qualified under 493.1411 performed the competency assessment of 1 out of 14 testing personnel in 2022 CMS TP#5). c. TP #3 who is not qualified under 493.1411 performed the competency assessment of # 1out of 14 testing personnel in 2022 CMS 209 TP#7). d. TP #5 who is not qualified under 493.1411 performed the competency assessment of 1 out of 14 testing personnel in 2022 (CMS209 #12) and 2023 (CMS 209 TP#1). 2. Testing Personnel #1 confirmed the findings above on 05/08/2023 around 1:45pm. -- 2 of 2 --

Summary Statement of Deficiencies D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of laboratory records and interview with the lead respiratory therapist, the laboratory failed to establish a maintenance policy to assess the maintenance/function for 1 of 1 Tru Temp NSF #3507 thermometer used to monitor the temperature of reagents for the GEM Premier 5000 blood gases analyzer from 2019 to the day of survey. Findings Include: 1. On the day of survey, 06/22/2021, the surveyor observed 1 of 1 Tru Temp NSF #3507 thermometer in use to monitor the temperatures of reagents for the GEM Premier 5000 blood gases analyzer. 2. The laboratory could not provide a maintenance policy or maintenance records for the thermometer. 3. The lead respiratory therapist confirmed the findings above on 06/22/2021 around 09:00 am. 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 --