Pediatric Associates, Pc

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on December 19, 2025. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on interview, document review, and laboratory policy review, the laboratory failed to document the names of staff who performed routine testing of proficiency testing (PT) for 4 of 5 PT events reviewed. Findings included: The "Laboratory Director Responsibilities" signed by the Laboratory Director (LD) and dated 12/18 /2017, revealed, "Continued enrollment in approved testing program a. Ensuring that samples are tested in accordance with CLIA [Clinical Laboratory Improvement Amendments] requirements. b. Results are returned within time frame established by program. c. Reports reviewed/signed by lab director. d. Review sampling of patient results ensure samples tested in same manner as patient specimens and cause of patient failure(s) are identified, corrected and documented. e. Ensure that lab staff /management are aware of CLIA requirements." The proficiency tests labeled "AAB- MLE M3 2025" dated 09/09/2025, "AAB-MLE M1 2025" dated 02/03/2025, "Nonchemistry M3 2024" dated 09/09/2024, and "Nonchemistry M2 2024" dated 05 /14/2024 revealed no name(s) or signature(s) of the testing personnel (TP) who performed the PT. During an interview on 12/19/2025 at 10:00 AM, TP #1 confirmed she was aware of the requirement to ensure completion of the PT attestation statements but had not done so. 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 was performed on December 6, 2023. The facility was found to be NOT in compliance with the CLIA conditions and standards for specialties /subspecialties for 42 CFR. Conditions: 493.1230 General Laboratory Systems 493.1441 Laboratory Director D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the American Association of Bioanalysts (AAB) Proficiency Testing (PT) provider documents and staff interview the laboratory failed to receive acceptable scores on the Specialty Hematology, analytes- White Blood Cell, Red Blood Cell, Hemoglobin, Hematocrit, Platelet Count, and differential for 2022 (event 1 and 2). The laboratory must verify the accuracy of any analyte, specialty, or subspecialty performed in the laboratory at least twice a year. REFERENCE: D-5215 D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of the American Association of Bioanalysts (AAB) Proficiency Testing (PT) provider documents and staff interview, the laboratory failed to receive acceptable scores on the Specialty- Hematology, Analytes-White Blood Cell, Red Blood Cell, Hemoglobin, Hematocrit, Platelet Count, and differential in 2022 ( event 1 and 2). The laboratory must verify the accuracy of any analyte, specialty, or subspecialty performed in the laboratory at least twice a year. Findings: 1. Review of 2022 AAB PT (event 1) results revealed the laboratory did not submit results for evaluation due to not receiving PT samples. The laboratory received event 2 samples at an unacceptable temperature. 2. The laboratory received unacceptable results for two consecutive PT events. The laboratory was unable to verify the accuracy of testing for the Speciality, Hematology, in 2022. 3. Staff interview with testing personnel #5, (CMS 209, Testing Personnel List), on December 6, 2023, at approximately 1:20 pm in the file room, confirmed the above aforementioned statements. 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 review of the Quality Control(QC) documentation for months December 2021- November 2023, performed on the Sysmex XP300 hematology analyzer, and staff interview, the Laboratory failed to provide legible printouts for review during the survey. Findings: 1. Review of the QC documents for December 2021- September 2022, revealed the QC printouts were illegible. Observation of the printer revealed the printer was not printing all of the information. The dates and QC results were not legible on the right side of the prinout. 2. Review of QC documents for October 2022 - March 2023 revealed the results were legible and acceptable. 3. Review of the QC documents for April 2023-November 2023 revealed the printouts were illegible. 4. Interview with testing personnel #5 (CMS 209 Testing Personnel Report) on December 6, 2023, at 1:30 pm, in the file room, confirmed the aforementioned statements. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform -- 2 of 4 -- test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on November 23, 2021. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D1002 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 staff interview, the laboratory failed to report SARS-CoV- 2 test results on all patients to the Department of Public Health(DPH). Findings include: 1. Record review revealed that SARS-CoV-2 results were not reported to the DPH, the account was suspended as of October 2021. 2. The CLIA Coordinator stated that results were being sent to the Department of Public Health , but was ceased for a period of time, due to staff shortage. The email was sent to the State on November 12, 2021 to DPH. 2. During an interview with the CLIA Coordinator on November 23, 2021 at approximately 2:00 PM, confirmed the SARS-CoV-2 results were not reported to the DPH. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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. 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 -- This STANDARD is not met as evidenced by: Based on observation and staff interview, the laboratory failed to ensure quality controls not be used after their expiration date as required. Findings include: 1. Observation during the laboratory tour on November 23, 2021 at approximately 10:09 AM, revealed the Hematology Sysmex quality controls expired on 11-17-2021. Observation during the tour on November 23, 2021 revealed there were no replacement controls or stability studies available at the time of survey. It was stated by the CLIA Coordinator that Sysmex was behind with their shipments for the quality controls for Hematology. 2. During an interview with the CLIA Coordinator in the laboratory on November 23, 2021 at approximately 10:09 AM, confirmed the quality controls for the Sysmex Hematology analyzer had expired and there were no replacements or stability studies for continued use of the expired regents. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on November 23, 2021. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D1002 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 staff interview, the laboratory failed to report SARS-CoV- 2 test results on all patients to the Department of Public Health(DPH). Findings include: 1. Record review revealed that SARS-CoV-2 results were not reported to the DPH, the account was suspended as of October 2021. 2. The CLIA Coordinator stated that results were being sent to the Department of Public Health , but was ceased for a period of time, due to staff shortage. The email was sent to the State on November 12, 2021 to DPH. 2. During an interview with the CLIA Coordinator on November 23, 2021 at approximately 2:00 PM, confirmed the SARS-CoV-2 results were not reported to the DPH. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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. 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 -- This STANDARD is not met as evidenced by: Based on observation and staff interview, the laboratory failed to ensure quality controls not be used after their expiration date as required. Findings include: 1. Observation during the laboratory tour on November 23, 2021 at approximately 10:09 AM, revealed the Hematology Sysmex quality controls expired on 11-17-2021. Observation during the tour on November 23, 2021 revealed there were no replacement controls or stability studies available at the time of survey. It was stated by the CLIA Coordinator that Sysmex was behind with their shipments for the quality controls for Hematology. 2. During an interview with the CLIA Coordinator in the laboratory on November 23, 2021 at approximately 10:09 AM, confirmed the quality controls for the Sysmex Hematology analyzer had expired and there were no replacements or stability studies for continued use of the expired regents. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on June 27, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory policy ad procedure manual (SOP) and staff interview, the laboratory failed to establish and follow written policies and procedures to assess testing personnel (TP) competency. Findings include: 1. SOP review revealed there was not a six-procedure CLIA competency policy and procedure to assess TP competency (initial, six-month, and annual thereafter). 2. An interview with Staff #1 (CMS 209) in a conference room on 6/27/2019 at approximately 4:00 p.m. confirmed there was not a six-procedure CLIA competency policy in the laboratory SOP. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step 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 -- performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)