Pearland Pediatrics Pa

Summary Statement of Deficiencies D0000 A recertified onsite survey was completed on 05/02/2025. Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions in the CLIA program, and recertification is recommended. D6066 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) (b)(6)(ii) Have documentation of laboratory training appropriate for the testing performed prior to analyzing patient specimens. Such training must ensure that the individual has- (b)(6)(ii)(A) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation, and storage of specimens; (b)(6)(ii) (B) The skills required for implementing all standard laboratory procedures; (b)(6)(ii) (C) The skills required for performing each test method and for proper instrument use; (b)(6)(ii)(D) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(6)(ii) (E) A working knowledge of reagent stability and storage; (b)(6)(ii)(F) The skills required to implement the quality control policies and procedures of the laboratory; (b) (6)(ii)(G) An awareness of the factors that influence test results; and (b)(6)(ii)(H) The skills required to assess and verify the validity of patient test results through the evaluation of quality control sample values prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on the review of the laboratory's CMS 209 form, the personnel's training records, and confirmed in an interview, the laboratory failed to have a training documentation prior to patient testing for 2 of 12 testing personnel performing moderate complexity testing on Medonic hematology analyzer. The findings were: 1. Review of the laboratory's submitted CMS 209 form, Laboratory Personnel Report (CLIA), signed by the laboratory direction on 05/01/2025, revealed the laboratory 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 -- identified 12 testing personnel performed moderate complexity testing on 1 of 1 Medonic hematology analyzer (SN:24071). 2. Review of the testing personnel's training record revealed no training documentation on Medonic hematology analyzer prior to patient testing. Testing personnel #4: Hired Date: 06/06/2023 Testing personnel #9: Hired Date: 08/19/2024 3. An interview on 05/02/2025 at 11:00 am in the conference room, the technical consultant (as indicated on the CMS 209 form) confirmed the above findings. Key: CMS=Center for Medicare and Medicaid Services -- 2 of 2 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions in the CLIA program, and recertification is recommended. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document 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 the review of the manufacturer's CDS/Medonic M-series maintenance, the laboratory's records in 2022, CMS 116 application and confirmed in an interview, the laboratory failed to have documentation of required maintenance on Medonic M- series hematology analyzer for 12 of 12 months in 2022 The findings were: 1. Review of the manufacturer's CDS/Medonic M-Series Maintenance (207054B 03.19.12) revealed the required maintenance as follows: Daily Maintenance Monthly cleaning procedures Six month cleaning procedures 2. Review of the laboratory's records in 2022 revealed the laboratory did not have documentation of required maintenance on Medonic M-series hematology analyzer (SN: 24071) for 12 of 12 months in 2022. 3. Review of the CMS 116 application signed by the laboratory director on 4/18/2023 revealed the hematology annual volume was 1905. 4. An interview with the technical consultant and a LVN on 4/21/2023 at 11:39 am in the conference room confirmed the above findings. Key: CMS=Center of Medicare and Medicaid Services 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 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of the laboratory policy, College of American Pathologists (CAP) proficiency testing (PT) records from 2020-2021, and confirmed in interview, the laboratory failed to analyze proficiency testing materials the same as patient samples for Complete Blood Count (CBC) analysis for six of six testing events in 2020 and 2021. Findings were: 1. Review of the laboratory policy Medonic M Series CBC testing (SOP #1, Revision #2) under Result Interpretation/Troubleshooting revealed "do not report flagged results to the physician. If a flag appears, run prime cycle if needed, let specimen sit for 5 minutes, mix specimen well, and repeat testing if enough sample allows for repeat." 2. Review of the CAP proficiency testing records from 2020 and 2021 revealed the following TM flags (too many WBC populations 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 -- found; slide review advised) for 6 of 6 testing events with no documentation of the repeat analysis. FH2-A 2020 FH2-3 "TM" FH2-B 2020 FH2-08 "TM" FH2-C 2020 FH2-11 "TM"; FH2-13 "TM"; FH2-14 "TM" FH2-A 2021 FH2-02 "TM"; FH2-03 "TM" FH2-B 2021 FH2-06 "TM" FH2-C 2021 FH2-12 "TM" 3. An interview with lab coordinator and technical consultant on 12/7/21 at 1030 hours in the break room confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. D5781

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --