Matthew Taub Md Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at MATTHEW TAUB MD PA on August 19, 2025. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiency: D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation, record review and staff interview, the laboratory used Sysmex CELL CLEAN AUTO expired since 07/01/2025 on the Sysmex XN-430 Complete Blood Cell analyzer. Findings Included: 1-During laboratory tour on 08/19/2025 at 10: 30 AM, the surveyor found the laboratory had in use CELLCLEAN AUTO with lot number A4102 expired since 07/01/2025. The laboratory do the Cleaning every Friday, based on this the laboratory used the expired CELL CLEAN AUTO six times. 2-Review of the Procedure Manual signed by the Laboratory Director on 12/10/2024, revealed that in the policy "Quality Control for Sysmex XN-L Analyzers", on page 5 listed the "CLEANING AGENT", "CELLCLEAN AUTO and on page 6 stated "Unopened, it is stable until expiration date printed on the container." 3-Review of instrument records, revealed that the laboratory performed 341 tests in the period of reference. 4-During an interview on 08/19/2025 at 10:40 am the Laboratory Consultant confirmed that the laboratory used the expired cleaning agent. 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 A recertification survey conducted on 02/22/2022 found that MATTHEW TAUB MD PA clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and staff interview, the laboratory received an unsatisfactory score in second event of 2021 for the specialty of Hematology. Findings include: Review of American Proficiency Institute (API) PT records revealed a score of 76 % for White Blood Cell Differential, 20% for Red Blood Cells, 20 % Hematocrit, 0% Hemoglobin, 0 % White Blood Cells, 20 % Platelets tests resulting in an overall score of 22 % in the second event of 2021. During an interview on 02/22/2022 at 11:30 AM, Technical Consultant B confirmed the proficiency testing failure. 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 An initial certification survey conducted at Matthew Taub MD PA on 5/28/2020 found that the laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on calibration record review and interview with Technical Consultant # A (TCA), the laboratory failed to have calibration documentation for the Complete Blood Cell Analyzer XN-430 after the expiration of the initial calibration on March 27th, 2020. Findings include: Review of the Calibration Certificate for analyzer XN- 430 serial number 11244, showed a calibration on 9/27/2019, the certificate states that this calibration expired on 3/27/2020. No documentation of further calibration available after the expiration of the initial calibration. The laboratory performed testing on 5/21/2020, 5/14/2020, 4/23/2020, 4/09/2020, and 4/02/2020, in total the laboratory tested 29 patients during this time. During an interview on 5/28/2020 at 11: 00 AM, the TCA confirmed that the laboratory failed to have documentation of the analyzer calibration after March 27th, 2020. 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 --