Urology Group Of Western New England Pc

Summary Statement of Deficiencies 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 record review and interview with the Practice Administrator (PA) the laboratory failed to ensure proficiency testing (PT) samples were tested by testing personnel (TP) who routinely perform testing in the specialty of Hematology. Findings Include: 1. Record review on 5/12/2026 of the laboratory's CMS for 209 revealed five TP. 2. Record review on 5/12/2026 of the September through December 2024, all of 2025 and 2026 to date attestation sheets for the laboratory's American Proficiency Institute Hematology/Coag PT Survey revealed all Semen Analysis attestation sheets were signed by the same one of five TP, demonstrating that one individual performed all PT over the reviewed time period. 3. Staff interview with the PA on 5/12/2026 at 10:30 AM confirmed the above PT was performed by only one TP. 4. The laboratory performs 25 Post Vasectomy Semen Analysis tests annually. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: 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 -- Based on record review and staff interview the Practice Administrator (PA) the Technical Consultant (TC) failed to ensure new Testing Personnel (TP) were evaluated twice annually in the first year of patient testing using all six required elements. Findings include: 1. Record review on 5/12/2026 of the laboratory's September through December 2024, all of 2025 and 2026 to date TP competency files revealed one of one new Post Vasectomy Semen Analysis TP did not receive two complete competency evaluations during the first year of patient testing using all six required elements. The initial competency was complete in full, however the second competency evaluation included only one of the six required elements and was limited to one photo identification. 2. Staff interview with the PA on 5/12/2026 at 11:00 AM confirmed the above findings. 3. The laboratory performs 25 Post Vasectomy Semen Analysis tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An initial CLIA certification survey was conducted for the Urology Group of Western New England laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. . D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to perform validation studies to validate all aspects of test performance prior to implementing the urine colony count screening procedure for patient testing and reporting as evidenced by the following: Urine colony count: a) The "List of Laboratory Test Performed On-Site" form indicated that in January of 2018 the laboratory put into place urine culture screens (urine colony counts on bi plate media). b) A review of the validation study for the procedure revealed that the validation of ten (10) patient urine specimens was performed in June of 2018 and signed off by the technical consultant on 7/2/18. c) 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 -- Interview with the technical consultant on 9/6/18 at 9:35 AM confirmed that the laboratory failed to perform validation studies prior to implementing the test for patient sample testing and reporting. -- 2 of 2 --