Oldham County Pediatrics

Summary Statement of Deficiencies D0000 A recertification survey was initiated on 09/02/2025. The facility was found to not be in compliance with the laboratory requirements of 42 CFR Part 493 with standard deficiencies cited. 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 direct observation, review of Sysmex XP-300 Hematology Analyzer instructions for use, laboratory maintenance records, and staff interview, the laboratory failed to document weekly maintenance for 3 of 5 months reviewed. During a tour of the laboratory on 9/2/2025 at 2:40 PM, a Sysmex XP-300 Hematology Analyzer (Serial Number C2776) was observed to be in use. Review of the Sysmex XP-300 instructions for use stated, "to ensure proper functioning of the instrument, it is necessary to periodically clean and service the instrument. Perform maintenance according to the schedule below. And record the results in the Maintenance checklist." The laboratory maintenance logs stated, "Weekly - Clean SRV tray." Further review of the laboratory maintenance records revealed the laboratory failed to document performance of the weekly maintenance for the following: December 2024 - Week 1,2,3,4 March 2025 - Week 1,2,3,4 July 2025 - Week 2,3,4 In an interview on 9/2/2025 at 3:30 PM in the office area, the Testing Personnel 1 (TP1) was asked to provide documentation of weekly maintenance for the Sysmex XP-300. No documentation was provided. This confirmed the findings. 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 -- (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require

Summary Statement of Deficiencies D0000 A Recertification Survey was initiated and concluded on 08/30/2023. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on observation, policy review, and interview, the laboratory failed to document the verification of accuracy for one (1) of one (1) new instruments used (Sysmex XP- 300 hematology analyzer). The findings include: During an observation, on 08/30 /2023 at 9:35 AM, a Sysmex XP-300 hematology analyzer was present and available for use. Review of the undated "Laboratory Policy and Procedure Manual," revealed there was not a procedure that defined how to perform and verify accuracy of the hematology analyzer. In an interview on 08/30/2023 at 9:35 AM, Testing Personnel (TP) #1 and TP #2, as listed on the CMS-209, stated the hematology analyzer had been installed on 05/05/2022 and placed into use for patient testing, effective 05/09 /2022. Approximately 400 CBCs were performed from the date of installation through the date of the survey. In continued interview on 08/30/2023 at 12:35 PM, TP #1 and TP #2 stated they were unaware of the requirement to perform an accuracy study as part of the test method change. 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 --