Westchester Pediatric Llc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at WESTCHESTER PEDIATRIC LLC from December 10, 2025, to December 16, 2025. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. Standard deficiencies cited are as follows: D5427 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(c) (c) Documentation. The laboratory must document all activities specified in this section. This STANDARD is not met as evidenced by: Based on record review and staff interview, the Laboratory failed to have documentation that the Laboratory Director reviewed and approve the Medonic M Series Complete Blood Counter (CBC) analyzer verification of performance study conducted on 11/18/2025. Findings included: 1-Review of the Method Validation for the Medonic M series CBC analyzer study performed on 11/18/2025 revealed that the study failed to have the acceptance signature of the Laboratory Director. The laboratory tested 130 patients from 11/18/2025 to 12/10/2025. 2-Review of the Medonic M Series Complete Blood Counter (CBC) analyzer New Instrument Validation Instructions PN 203129A stated "All validation information must be signed by the Laboratory Director and must be saved for the life of the instrument but no less than 2 years." 3-During an interview on 12/10/2025 at approximately 11:41 AM, Testing Personnel #1 confirmed that the laboratory failed to have documentation that the Laboratory Director reviewed and approved the verification performance study for the hematology analyzer. D6047 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b(8)(i) 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 -- (b)(8)(i) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; This STANDARD is not met as evidenced by: Based on record review and staff interview, the Technical Consultant (TC) or a designee failed to do direct observation of Patient testing during competency evaluation for testing personnel (TP) on four (4) out five (5) in 2025. Findings included: 1- Review of FORM CMS 209 signed by the Laboratory Director on 12/01 /2025, revealed the following: Laboratory Director (LD) was also the Clinical Consultant (CC) and the Technical Consultant (TC) for the Hematology specialty. The laboratory had five testing personnel (TP1, TP2, TP3, TP4, and TP5). 2- Review of Quality Assurance Plan under the section for PERSONNEL TRAINING AND QUALIFICATIONS stated that "Laboratory Director will use personal observation to perform ongoing assessment of all employees of the laboratory to ensure competence of the job performance." 3- Review of competency assessments records titled "LABORATORY PERSONNEL EVALUATION" for TP2 (04/02/2025), TP3 (04/02 /2025), TP4 (04/02/2025), and TP5 (01/06/2025) revealed that direct observations of patient testing were observed and signed by TP1, who had no delegation letter to do personnel competency. 4- During interview on 12/10/2025 at approximately 1:26 PM, the LD/TC admitted that she did not performed direct observation of patient testing in 2025 during personnel competency evaluations for TP2, TP3, TP4 and TP5 D6050 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iv) (b)(8)(iv) Direct observation of performance of instrument maintenance and function checks; This STANDARD is not met as evidenced by: Based on record review and staff interview, the Technical Consultant (TC) or a designee failed to do direct observation of performance of instrument and function check of the MEDONIC Hematology analyzer during competency evaluation for testing personnel (TP) on four (4) out five (5) in 2025. Findings included: 1- Review of FORM CMS 209 signed by the Laboratory Director on 12/01/2025, revealed the following: Laboratory Director (LD) was also the Clinical Consultant (CC) and the Technical Consultant (TC) for the Hematology specialty. The laboratory had five testing personnel (TP1, TP2, TP3, TP4, and TP5). 2- Review of Quality Assurance Plan under the section for PERSONNEL TRAINING AND QUALIFICATIONS stated that "Laboratory Director will use personal observation to perform ongoing assessment of all employees of the laboratory to ensure competence of the job performance. 3- Review of competency assessments records titled "LABORATORY PERSONNEL EVALUATION" for TP2 (04/02/2025), TP3 (04/02/2025), TP4 (04/02 /2025), and TP5 (01/06/2025), revealed that direct observations for the performance of instrument and function check of the MEDONIC Hematology analyzer were observed and signed by TP1, who had no delegation letter to do personnel competency. 4- During interview on 12/10/2025 at approximately 1:26 PM, the LD /TC admitted that she did not perform direct observation in 2025 for the performance of instrument and function check during personnel competency evaluations for TP2, TP3, TP4 and TP5. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Westchester Pediatrics LLC on 04/26/2022. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Conditions were cited: D3000 Facility Administration 493.1100 D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to report SARS-Co-V-2 test results as required since testing began on 11/03/2021. Findings Included: During a tour of the laboratory on 04/26/22 at 10:00 AM revealed the laboratory was using Becton, Dickinson and Company BD Veritor System for Rapid Detection of SARS- CoV-2 (Lot# 2007152 Expiration 10/16/2022) antigen testing. Review of the SARS- COV-2 log revealed that there were 333 test performed since testing started on 11/03 /2021. There were 26 positive tests performed on 04/25/22, 04/18/22, 04/19/22, 04/07 /22, 03/01/22, 01/28/22, 01/24/22, 01/19/22 (2 Patients), 01/12/22, 01/07/22, 01/05/22 (3 Patients), 12/30/21, 12/28/21, 12/27/21, 12/23/21 (3 Patients), 12/21/21, 12/17/21 (4 Patients), and 12/16/21. Interview on 04/26/22 at 11:55 AM the Office Manager confirmed that no SARS-Cov-2 results to the Department of Health. 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 Westchester Pediatrics LLC clinical laboratory is in compliance with the 42 CFR Part 493, Requirements for Laboratories. A CLIA recertification survey was conducted 04 /26/2022. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to report SARS-Co-V-2 test results as required since testing began on 11/03/2021. Findings Included: During a tour of the laboratory on 04/26/22 at 10:00 AM revealed the laboratory was using Becton, Dickinson and Company BD Veritor System for Rapid Detection of SARS- CoV-2 (Lot# 2007152 Expiration 10/16/2022) antigen testing. Review of the SARS- COV-2 log revealed that there were 333 test performed since testing started on 11/03 /2021. There were 26 positive tests performed on 04/25/22, 04/18/22, 04/19/22, 04/07 /22, 03/01/22, 01/28/22, 01/24/22, 01/19/22 (2 Patients), 01/12/22, 01/07/22, 01/05/22 (3 Patients), 12/30/21, 12/28/21, 12/27/21, 12/23/21 (3 Patients), 12/21/21, 12/17/21 (4 Patients), and 12/16/21. Interview on 04/26/22 at 11:55 AM the Office Manager confirmed that no SARS-Cov-2 results to the Department of Health. 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 announced CLIA recertification survey was conducted at Westchester Pediatrics LLC on 01/30/2020. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Conditions were cited: D6064 - Testing Personnel Qualifications - 493.1423(a) D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview with the Lab Manager the laboratory failed to monitor quality control (QC) over time for shifts and trends for 2 (2018-2020) out of 2 years reviewed. Findings Included: Review of QC records revealed only daily QC. There was no documentation of monitoring the shifts and trends of the QC over time. Interview on 01/30/20 at 12:07 PM the Lab Manager confirmed that they did not have a system in place to monitor shifts and trends of the QC over time. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 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 laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on record review and interview with the Lab Manager the laboratory failed to verify the education of 1(#E) out of 5 (#A-E) Testing Personnel (See D6065). D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on record review and interview with the Lab Manager the laboratory failed to verify the education of 1(#E) out of 5 (#A-E) Testing Personnel. Findings Included: Review of the CMS 209 signed and dated by the Laboratory Director on 01/29/2020 revealed that there were 5 Testing Personnel. Review of employee files revealed only a Medical Assistant certificate in Testing Personnel #E's file. There were no diplomas for review. Interview on 01/30/20 at 12:00 PM the Lab Manager confirmed that the certificate was all that they had for review. -- 2 of 2 --

Summary Statement of Deficiencies D1000 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(c) Certificate of waiver tests. A laboratory may qualify for a certificate of waiver under section 353 of the PHS Act if it restricts the tests that it performs to one or more of the following tests or examinations (or additional tests added to this list as provided under paragraph (d) of this section) and no others: (1) Dipstick or Tablet Reagent Urinalysis (non-automated) for the following: (i) Bilirubin; (ii) Glucose; (iii) Hemoglobin; (iv) Ketone; (v) Leukocytes; (vi) Nitrite; (vii) pH; (viii) Protein; (ix) Specific gravity; and (x) Urobilinogen. (2) Fecal occult blood; (3) Ovulation tests-visual color comparison tests for human luteinizing hormone; (4) Urine pregnancy tests - visual color comparison tests; (5) Erythrocyte sedimentation rate-non-automated; (6) Hemoglobin- copper sulfate-non-automated; (7) Blood glucose by glucose monitoring devices cleared by the FDA specifically for home use; (8) Spun microhematocrit; and (9) Hemoglobin by single analyte instruments with self-contained or component features to perform specimen/reagent interaction, providing direct measurement and readout. This STANDARD is not met as evidenced by: Based on observation, record review and interview with laboratory manager, laboratory failed to follow manufacturer's instructions to check and record quality controls for blood glucose test using TRUEresult blood glucose monitoring system. The findings include: On 5/10/18 at 11:30 AM, surveyor observed that TRUEresult blood glucose monitoring system did not have quality control materials to perform control tests. Record review from June 2016 to May 10, 2018 showed no quality control records for blood glucose test as explained in manufacturer's instructions for TRUEresult blood glucose monitoring system. On 5/10/18 at 2:45 PM, laboratory manager confirmed that laboratory did not follow the manufacturer's instructions and did not test the quality control materials for glucose test for TRUEresult blood glucose monitoring system. 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 -- D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of