Dr Soos Pediatrics Pc

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification Survey was completed on November 21, 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: D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: A review of 2023 - 2025 AAB Proficiency Testing Records confirmed that the laboratory failed two out of three ( 2 out of 3) consecutive proficiency testing challenges. THE FINDINGS INCLUDE: 1. A review of 2023 - 2025 AAB Proficiency Testing Records confirmed that the laboratory received the scores below: - AAB-MLE M1 2025 event - Erythrocyte Count score of 60% - AAB-MLE M3 2025 event - Erythrocyte Count score of 40% 2. An exit interview, with Laboratory Staff, on November 21, 2025, at 1:00pm confirmed that the laboratory failed two out of three ( 2 out of 3) consecutive proficiency testing challenges. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of 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 -- results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on November 9, 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: D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on Testing Personnel (TP) competencies, and staff interview, the Laboratory Director (LD) performing the duties of the Technical Consultant, failed to provide competencies for all testing personnel in 2020 and 2021. Findings: 1. Review of the Testing Personnel competency records, revealed there was one competency performed (initial)out of eight employees that were employed for the year 2020. For the year 2021, there was four competencies performed out of 13 employees listed on the Laboratory Personnel Report (CMS 209). 2. Staff interview with #12 (CMS 209 form) on November 9, 2021, at approximately 1:30 pm in the conference room, confirmed the above aforementioned statement. 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 Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on July 30, 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: D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the American Association of Bioanalysts(AAB) proficiency testing (PT) records for 2018 and staff interview, the Laboratory Director (LD) failed to sign the attestation statement for 2018 QA, and QB. Findings: 1. Based on review of the AAB PT documents, the LD failed to attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. The testing personnel did sign the attestation statement. 2. Interview with staff #13 and #14(CMS form 209), on July 30, 2019 at approximately 1:30pm in the conference room, confirmed that the attestation statements for 2018 QA and QB, were signed by the testing personnel but not by the LD. 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 proficiency testing desk review was completed on August 27, 2018. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: The laboratory failed to maintain satisfactory proficiency testing (PT) performance for automated red blood cell count (RBC) and hematocrit (HCT) in 2017 event two, 2018 event one and 2018 event two, resulting in the second unsuccessful occurrence for RBC and HCT. (Refer to D2130). 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 -- D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the laboratory's 2017 and 2018 proficiency testing (PT) evaluation reports, the laboratory failed to maintain satisfactory performance for three of four consecutive proficiency testing events for automated red blood cell count (RBC) and hematocrit (HCT) resulting in the second unsuccessful PT occurrence for RBC and HCT. The findings include: 1. Review of the 2017 event two evaluation report from the American Academy of Family Physicians (AAFP) revealed unacceptable scores for RBC and HCT on for sample numbers HD 7, 8 and 10 resulting in scores of 40% for both analytes. 3. Review of the 2018 event one evaluation report from the American Association of Bioanalysts (AAB) revealed unacceptable scores for RBC and HCT on sample numbers 1 ,2,3,4 & 5, resulting in scores of 0% for both analytes. 4. Review of the 2018 event two evaluation report revealed unacceptable scores for RBC on samples numbers 1,3,4 &5 resulting in a score of 20 % and unacceptable scores on HCT for sample numbers 1,2,3,4 & 5, resulting in a score of 0 % . D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: The laboratory director failed to maintain compliance with successful RBC and HCT proficiency testing (PT) for three of four consecutive events, resulting in the second unsuccessful PT occurrence for RBC and HCT. (Refer to D6019) D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform 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)(iv) Ensure that an approved