Wichita Urology Group

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) from the provider American Association of Bioanalysts (AAB) performed in 2021 and interview with Laboratory Manager revealed that the Laboratory Director (LD) or approved designee failed to attest and sign evaluations on three events that proficiency testing samples were handled in the same manner as patient samples at time of survey. Findings: 1. Review of the attestation and evaluation pages for PT from AAB revealed no signature of the LD or approved designee was present on AAB 2021 events: a. Urinalysis Q3 b. I-Stat Chemistry Q3 c. Special Chemistry Q3 2. Interview with the Laboratory Manager on 5 /19/2022 at 10:45 a.m. confirmed, the laboratory director (LD) or approved designee failed to attest and sign evaluations on three events that proficiency testing samples were handled in the same manner as patient samples at time of 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 1 --

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 proficiency testing (PT) records, the laboratory failed to successfully participate in PT from American Association of Bioanalysts (AAB) under the specialties: 1. Routine Chemistry for the regulated analytes: Chloride (CL), Creatinine, Glucose (non waived), Potassium (K), Sodium (NA) and Blood Urea Nitrogen (BUN). See D2096. 2. Hematology for the regulated analytes: Hematocrit (HCT) and Hemoglobin (HGB). See D2130. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of PT from the provider AAB under Routine Chemistry for the regulated analytes: CL, Creatinine, Glucose (non waived), K, NA and BUN revealed the following performance scores for PT: 1 .First testing event 2021 revealed a score of 20% for CL, Creatinine, Glucose (non waived), K, NA and BUN. 2. Second testing event 2021 revealed a score of 0% for CL, Creatinine, Glucose (non waived), K, NA and BUN. 3. Phone interview with the lab manager on 8/9/21 at 9:05 a.m. confirmed, the laboratory failed to achieve an acceptable score of 80% or higher for two of three consecutive testing events on the regulated analytes of CL, Creatinine, Glucose (non waived), K, NA and BUN. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of PT from the provider AAB under Hematology for the regulated analytes of HCT and HGB revealed the following performance scores for PT: 1. First testing event 2021 revealed a score of 20% for HCT and HGB. 2. Second testing event 2021 revealed a score of 0% for HCT and HGB. 3. Phone interview with the lab manager on 8/9/21 at 9:05 a.m. confirmed, the laboratory failed to achieve an acceptable score of 80% or higher for two of three consecutive testing events on the regulated analytes of HCT and HGB. -- 2 of 2 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on a review of manufacturer's instructions, temperature monitoring records and interview, the laboratory failed to ensure that chemistry controls were stored at the required temperature. Findings: 1. A review of the manufacturer's instructions for Bio- Rad Immunoassay Plus Control revealed that the proper unopened storage requirement was -20 degrees Celsius (C). to -70 degrees C. 2. A review of the temperature monitoring system records from 1/01/19 to 1/21/21 for the lab freezer showed temperatures recorded during this period failed to maintain consistent manufacturuer's required temperature. The 2 year period of daily temperatures recorded for the freezer showed only 7 days when temperatures were within the acceptable range to meet the manufacturer's requirements. Temperature log sheets listed a range of -10 C to -30 C. 3. Interview with General Supervisor (GS) 1/21/21 at 10:40 a.m. confirmed, the laboratory failed to ensure that chemistry controls were stored at the required temperature. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for 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; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain 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 -- their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on a review of competency assessment records and interview, the technical supervisor failed to evaluate the competency for one of three testing personnel (TP). Findings: 1. No competency assessment records on TP #1 for the years 2019 and 2020 were made availible at the time of survey. 2. Interview with GS on 1/21.21 at 10:05 a. m. confirmed, the technical supervisor failed to evaluate the competency for one of three testing personnel (TP). -- 2 of 2 --