Urology Assoc Pc-Skyline Medical Ctr

Summary Statement of Deficiencies D0000 The Urology Associates, P.C.-Skyline laboratory was found to be in compliance with the requirements at 42 CFR, Part 493, 'Requirements for Laboratories' as a result of an onsite survey on June 18, 2025. 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 D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of laboratory policy, proficiency testing (PT) records, and staff interview, the laboratory failed to follow it's own policy for PT record retention in 2021 and 2022 for two of six events reviewed. The findings include: 1. Review of laboratory policy titled "CLINICAL QUALITY ASSURANCE/NOTIFICATION OF LABORATORY CHANGES AND LABORATORY CLOSURE POLICIES" revealed the following: "Urology Associates, P.C. has set the following minimum retention times..." "Proficiency Testing Results and Associated Worksheets" with a minimum retention requirement of two years. 2. Review of the laboratory's American Proficiency Institute (API) PT records revealed the following: Attestation statements provided by the PT program for events 2021 Event 3 and 2022 Event 3 were not retained. Performance evaluation review documentation was not retained for API PT 2022 Event 3. 3. Interview on 06/01/2023 at 11:00 am with the technical consultant confirmed the laboratory failed to follow it's own policy for PT record retention in 2021 and 2022. 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 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 review of employee personnel records for 2018-19 and interview with the Technical Consultant (TC) , the laboratory's technical consultant failed to document 4 of the six required criteria for assessing personnel competency. The findings include: 1) Review of employee personnel records for 2018-19 did not reveal documentation of 4 of the six required criteria of competency that include: direct observation of routine patient test performance; monitoring the recording and reporting of test results; review of intermediate test results or worksheets, and, assessment of problem solving skills. 2) An interview with the TC on September 11, 2019 at 12:30am confirmed testing person 1 of 3 evaluated during 2018 and 2019 were not evaluated using all of the six criteria for competency required by Centers for Medicare and Medicaid (CMS). 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 --