J D C Pediatrics

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: A. Based on record review, lack of documentation, and interview with the Office Coordinator (OC), the laboratory failed to ensure Quality Control (QC) was performed as required per manufacturers (Siemens Multistix) and laboratory requirements when dipstick urinalysis examinations were performed for 2 of 2 years from 01/31/2024 to 12/09/2025. Findings include: 1. Manufacturer instructions for the Siemens Multistix 10SG urine dipstick stated, "Quality Control: Test known negative and positive specimens or controls whenever a new bottle is first opened". 2. The laboratory's Quality Assurance Policy for CLIA waived Testing stated, "For all other CLIA waived test kits, manufacturers recommendations are followed for quality controls." 3. On the day of survey, 12/09/2025 at 9:51 am, review of the laboratory's Urinalysis quality control (QC) records revealed the laboratory failed to perform a known negative control on the Siemens Multistix 10SG dipstick for 2 of 2 years from 1/31/2024 to 12/09/2025. 4. The laboratory performed 58 urine dipstick examinations from 1/31/2024 to 12/09/2025. (from OC, dated 12/19/2025). 5. The OC confirmed the above findings on 12/09/2025 at 1:00 pm. B. Based on lack of documentation and interview with the Office Coordinator (OC), the laboratory failed to monitor and document room temperature to ensure reagent storage conditions were met for 2 of 2 years when urinalysis testing was performed from 1/31/2024 to 12/09/2025. Findings include: 1. On the day of the survey, 12/05/2025 at 11:15 am, the laboratory failed to provide documentation for the room temperature readings performed to ensure storage conditions were met for the following reagent kits used for urinalysis testing for 2 of 2 years from 1/31/2024 to 12/09/2025: - Siemens Multistix 10SG dipstick (manufacturer storage temperature 15 to 30 Celsius). 2. The laboratory performed 58 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 -- urine dipstick examinations from 1/31/2024 to 12/09/2025. (from OC, dated 12/19 /2025). 3. The OC confirmed the above findings on 12/09/2025 at 1:00 pm. 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 observation in the laboratory, review of laboratory temperature records, and interview with the Office Coordinator (OC), the laboratory failed to monitor and document temperatures to ensure acceptable reagent storage temperatures were maintained on weekends and holidays for EMB Uricult reagents stored for 203 of 678 days from 01/31/2024 to 12/09/2025. Findings include: 1. On the day of survey, 12/09 /2025, at 9:51 am, during the tour of the laboratory, the surveyor observed the following reagents stored in the laboratory: - EMB Uricult paddles, manufacturer storage requirements 45F to 77F. 2. Review of the laboratory's temperature records revealed the laboratory failed to monitor and document temperatures to ensure acceptable reagent storage temperatures were maintained for 203 of 678 days from 01 /31/2024 to 12/09/2025 when the laboratory was closed. 3. The laboratory performed 77 urine culture examinations in 2024 (CMS 116, estimated annual volume, dated 12 /03/2025). 4. The OC confirmed the above findings on 12/09/2025 at 1:00 pm. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) (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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview with the Office Coordinator (OC), the laboratory failed to follow established written policies for an ongoing mechanism to monitor, assess and when indicated, correct problems identified in the postanalytic systems specified in 493.1291 for 1 of 1 Testing Personnel (TP) that performed urine culture (colony count) testing in 2025. Findings include: 1. The laboratory's Quality Assessment Procedures stated, "All new staff will have monthly chart audits every 30 days for the first 90 days of employment to include lab documentation and performance, then quarterly if documentation is accurate." 2. On the day of survey, 12/09/2025 at 10:56 am, the laboratory failed to provide documentation for the monthly chart audits of urine culture (colony count) testing performed for the first 90 days of employment for TP #11 (CMS 209, dated 12 -- 2 of 3 -- /03/2025) in 2025. 3. The laboratory performed 77 urine culture examinations in 2024 (CMS 116, estimated annual volume, dated 12/03/2025). 4. The OC confirmed the above findings on 12/09/2025 at 1:00 pm. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; and This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview with the Office Coordinator (OC), the laboratory failed to ensure established procedures for the twice annual verification of accuracy for urine culture (colony count) testing were followed for 38 of 100 peer review evaluations performed from 1/31/2024 to day of survey. Findings include: 1. The laboratory's Urine Colony Count Proficiency Testing policy stated "After the incubation period one physician will read a paddle and write the results. A second physician will read the same paddle and write the results. The lab director, the assistant director or the clinical supervisor will compare results to ensure results are the same". 2. On day of survey, 12/09/2025 at 9:56 am, review of the laboratory's urine colony count proficiency testing records revealed the laboratory failed to provide documentation for the review of 38 of 100 peer review evaluation records by a second physician for the twice annual verification of accuracy for urine culture (colony count) testing performed from 1/31/2024 to 12/09/2025. 3. The OC confirmed the above findings on 12/09/2025 at 1:00 pm. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview with the Office Coordinator (OC), the Technical Consultant (TC) failed to assess the competency of 10 of 10 Testing Personnel (TP) that performed urine culture (colony count) examinations in 2024. Findings Include: 1. The laboratory's Quality Assurance Policy stated, "7. Personnel Competency, Assessment: Conduct competency reassessments 6 months after hire and annually thereafter, or whenever there is a change in procedures." 2. On the day of survey, 12/09/2025 at 9:30 am, the laboratory failed to provide competency assessment records for 10 of 10 TP (CMS 209, TP#1, TP#2, TP#3, TP#4, TP#5, TP#6, TP#7, TP#8, TP#9, TP#10, dated 12/03/2025), that performed urine culture examinations in 2024. 3. The laboratory performed 77 urine culture (colony count) examinations in 2024 (CMS 116, estimated annual volume, dated 12/03/2025). 4. The OC confirmed the above findings on 12/09/2025 at 1:00 pm. -- 3 of 3 --

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 review of laboratory's temperature records, observation of the laboratory, and interview with the office coordinator (OC), the laboratory failed to monitor and document room temperatures to ensure operating conditions were met for the proper storage of reagents for bacteriology testing from 5/24/2022 to the day of survey. Findings Include: 1. On the day of the survey, 01/31/2024 at 11:40 am, review of laboratory's temperature logs revealed the laboratory failed to monitor and document room temperature for weekends and holidays from 5/24/2022 to the day of survey. 2. During observation of the laboratory following reagent was found to be stored at room temperature in the laboratory. 1 of 1 Uricult-CLED EMB No 1000- Temperature requirements 7-25-degree Celsius. 3. The hours of laboratory testing per the CMS 116 are Monday-Friday 08:00 am to 05:00 pm. 4. The OC confirmed the findings above on 1/31/2024 at 12:30 pm. * Repeated deficiency 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 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 -- 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, laboratory's temperature record review, and interview with the office coordinator (OC), the laboratory failed to establish a maintenance protocol that ensures equipment performance for 1 of 1 thermometer used for Room Temperature (RT) monitoring for storage of reagent for bacteriology testing from 5/24/2022 to the day of the survey. Findings include: 1. At the time of survey, 01/31/2024 at 12:00 pm, the laboratory failed to provide a maintenance protocol for 1 of 1 thermometer (Thermco S/N 83695) used for RT monitoring from 5 /24/2024 to the day of survey. 2. The following reagent was found to be stored at room temperature in the laboratory. 1 of 1 Uricult-CLED EMB No 1000- Temperature requirements 7-25-degree Celsius. 3. The OC confirmed the findings above on 01/31/2024 at 12:30 pm. -- 2 of 2 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of peer review record and interview with the office coordinator, the laboratory failed to verify twice a year the accuracy of urine culture for 11 of 11 testing personnel (TP) from 5/24/2020 to 5/24/2022. Findings include: 1. On the day of survey, 05/24/2022 at 09:32 AM, review of the peer review record revealed the laboratory could not provide biannual verification of accuracy performance for 11 of 11 TP (CMS 209 Personnel # 1,2,3,4,5,6,7,8,9,10, and 11) from 5/24/2020 to 5/24 /2022. 2. The office coordinator confirmed the above findings on 05/24/2022 at 10:40 AM. 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, lack of temperature record, and interview with 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 office coordinator at the time of inspection, the laboratory failed to document and monitor the refrigerator temperature for the storage of Urinalysis and Alere Cholesterol LDX quality controls (QC) from 05/24/2020 to 05/24/2022. Findings include: 1. Observation of the laboratory on 05/24/2022 at 10:15 AM, showed the following QC were stored in refrigerator as per manufacturer's instructions (2-8 degree Celsius). 1 of 1 box of Microbiologic Urine Control Kit LOT#22108103, EXP- 4/03/2023 1 of 1 box of Abbott Cholestatic LPX HDL Control LOT#429474, EXP-10 /31/2022 2. Laboratory failed to provide temperature record for the refrigerator. 3. Interview with office coordinator confirmed the findings above on 05/24/2022 at 10: 40 AM. -- 2 of 2 --

Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) 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: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on observation of the laboratory and interview with the office coordinator, the laboratory failed to establish and perform maintenance and function check protocols for 2 of 2 thermometers used to monitor the room and incubator temperatures for Uricult media from 2017 to the date of survey. Findings Include: 1. On the day of survey, 01/07/2020, observation of the laboratory revealed the following 2 thermometers were is use to monitor the room and incubator temperatures for uricult media from 11/16/2017 to 01/07/2020: - 1 of 1 Habor thermometer (laboratory room thermometer). - 1 of 1 CLIA Temp NIST Traceable thermometer (incubator thermometer). 2. The office coordinator could not provide maintenance or function check records for the thermometers in use. 3. The office coordinator could not provide maintenance or function check procedures for the thermometers in use. 4. The office coordinator confirmed the findings above on 01/07/2020 around 10:35 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 --