Associated Urologists, Pa

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 the lack of documentation and interview with the laboratory director (LD), the technical consultant failed to evaluate and document competency on five of five testing personnel for all of 2020, 2021 and to date 1/19/22. Findings: 1. Request was made for competency documentation for all testing personnel. No documentation of competency assessment for five of five testing personnel was made available at the time of survey. 2. Interview with the LD on 1/19/22 at 1:40 p.m. confirmed, the technical consultant failed to evaluate and document competency on five of five testing personnel for all of 2020, 2021 and to date 1/19/2022. 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 D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on review of approved reference ranges in the laboratory procedure manual and interview with the Technical Consultant #1, the laboratory failed to ensure the test report included pertinent normal ranges as determined by the laboratory. Two of the nine parameters for microscopic urinalysis listed on the laboratory information system (LIS) report differed from those in the approved procedure manual. Findings: 1. Review of the patient reports from the LIS system revealed two of the nine parameters for microscopic urinalysis exams on the LIS report did not match the procedure manual. LIS patient report ranges Procedure ranges Bacteria none/HPF 0-5/HPF Crystals none/HPF 0-3/HPF 2. Interview with the Technical Consultant #1 on October 10, 2019 @1:30 PM confirmed the laboratory failed to ensure correct reference ranges approved in the procedure manual were included on the LIS patient report. 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 --