York Urologic Uropartners

Summary Statement of Deficiencies D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review laboratory policies and procedures, laboratory records, patient testing records, lack of documentation, laboratory test volume worksheet and interview with laboratory representative, the laboratory failed to perform bi-annual method accuracy evaluations for qualitative semen analysis testing in 2023 through the survey date of 11 /20/2025 (See D5217), the laboratory failed to outline all components of a test procedure for qualitative semen analysis (See D5403), the laboratory failed to establish quality control procedures to monitor quality performance of qualitative semen analysis for 46 of 46 patients tested in 2024 and 2025 (See D5441), D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on lack of documentation, and interview with the laboratory representative; the laboratory failed to perform bi-annual method accuracy evaluations for qualitative semen analysis testing in 2023 through the survey date of 11/20/2025. Findings include: 1. Review of laboratory records found no documented bi-annual method accuracy evaluations for qualitative semen analysis testing in 2023 through the survey Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- date of 11/20/2025. 2. Interview with the laboratory representative on 11/20/2025, at 10:32 am, confirmed that the laboratory failed to perform bi-annual method accuracy evaluations for qualitative semen analysis testing. 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 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 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: Based on review of the CASPER Report 0096D, review of American Proficiency Institute (API) proficiency testing records, and interview with office manager (OM); the laboratory failed to successfully participate in proficiency testing (PT) for bacteriology during events two of 2022 and event one of 2023. Refer to D2028. D2028 BACTERIOLOGY CFR(s): 493.823(e) Failure to achieve an overall testing event score of satisfactory performance for two 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 -- consecutive testing 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 CASPER Report 0096D, review of American Proficiency Institute (API) proficiency testing records, and interview with office manager (OM); the laboratory failed to successfully participate in proficiency testing (PT) for bacteriology during events two of 2022 and event one of 2023. Findings include: 1. Review of the CASPER Report 0096D ran on 03/31/2023 and API PT documentation identified unsuccessful PT performances for the sub-specialty of bacteriology. a. BACTERIOLOGY Bacteriology - EVENT- 2, 2022 = 78% - Unsatisfactory b. BACTERIOLOGY Bacteriology - EVENT- 1, 2023 = 75% - Unsatisfactory 2. On 04 /03/2023 at 11:00 a.m., OM confirmed finding one. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of the CASPER Report 0096D, review of American Proficiency Institute (API) proficiency testing records, and interview with office manager (OM); the laboratory director failed to meet the requirements of this condition. The laboratory director failed to ensure test methods were performed as required to provide accurate and reliable results for the sub-specialty of bacteriology in 2022 through 2023. Refer to D6087. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on review of the CASPER Report 0096D, review of American Proficiency Institute (API) proficiency testing records, and interview with office manager (OM); the laboratory director failed to ensure test methods were performed as required to provide accurate and reliable results for the sub-specialty of bacteriology in 2022 through 2023. Findings Include: 1. The laboratory failed to ensure successful participation in proficiency testing for the sub-specialty of bacteriology for event two of 2022 and event one of 2023. Refer to D2028. -- 2 of 2 --