Wichita Urology Group West

Summary Statement of Deficiencies 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 the lack of documentation of accuracy checks from 1/1/22 to 2/23/23 and interview with testing personnel (TP) #1, the laboratory failed to establish means to verify the accuracy of urine sediment and post vasectomy semen testing twice a year for 2022 and to date of survey 2023. Findings: 1. Request was made for documentation of accuracy checks for urine sediment and post vasectomy semen testing during 2022, and 2023. No documentation for this request was made available at the time of survey. 2. Interview with TP #1 on 2/23/23 at 8:15 a.m. confirmed, the laboratory failed to establish means to verify the accuracy of urine sediment and post vasectomy semen testing twice a year for 2022 and to date of survey 2023. 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 D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of patient test reports and interview, the laboratory failed to include the address of the laboratory location were the test was performed on the patient report. Findings: 1. Review of selected patient test reports showed the laboratory address where the test was perform was missing. 2. Interview with the Director of Operations on 6/7/21 at 3:00 p.m. confirmed the laboratory failed to include the address of the laboratory location were the test was performed on the 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 --

Summary Statement of Deficiencies D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: Based on review of competencies and interview with the technical consultant #2 on March 15, 2019 at 10:00 AM confirmed, the technical consultant failed to evaluate and document the initial competency for testing personnel #4. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for 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: Based on review of competencies and interview with the technical consultant #2 on March 15, 2019 at 10:00 AM confirmed, the technical consultant failed to evaluate and document competency semiannually during the first year of laboratory testing for testing personnel #2. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) 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 -- The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of competencies and interview with the technical consultant #2 on March 15, 2019 at 10:00 AM confirmed, the technical consultant failed to evaluate and document the annual competency for testing personnel #1 for 2017 and failed to evaluate and document the annual competency for testing personnel #3 for 2017 and 2018. -- 2 of 2 --