Madison Medical Urology

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 surveyor review of American Proficiency Institute (API) proficiency testing (PT) records and interview with the regional director, staff A, the laboratory director and testing personnel did not attest to the routine integration of PT samples into the patient workload using the laboratory's routine methods for five of six urine microscopy events reviewed from event 2 in 2022 through event 1 in 2024. Findings include: 1. Review of API PT records showed no signatures on the attestation forms for the following events: 2022 Hematology/Coagulation-2nd Event and 3rd Event 2023 Hematology/Coagulation- 2nd Event and 3rd Event. 2023 Hematology /Coagulation-1st Event not submitted. 2024 Hematology/Coagulation-1st Event 2. Interview with staff A on June 26, 2024, at 9:50 AM confirmed the laboratory director and testing personnel did not attest to the routine integration of PT samples into the patient workload using the laboratory's routine methods from event 2 in 2022 through event 1 in 2024. D3029 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(2) Test procedures. Retain a copy of each test procedure for at least 2 years after a procedure has been discontinued. Each test procedure must include the dates of initial use and discontinuance. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on surveyor review of laboratory procedures and interview with the regional director, staff A, the laboratory did not retain one of one discontinued procedure with the date the procedure was discontinued. Findings include: 1. Review of laboratory procedures showed the "Quality Assurance Program" procedure had been updated in July 2022. Further review showed no evidence of the previous procedure with a discontinued date. 2. Interview with staff A on June 26, 2024, at 9:58 AM confirmed the laboratory did not retain a copy of the previous quality assurance procedure with date of discontinuance. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory procedures and competency assessments, and interview with the regional director, staff A, the laboratory did not follow their written policies for training and competency evaluation for two of two current testing personnel. Findings include: 1. Review of the "Quality Assurance Program" procedure stated "Personnel performing non-waived testing must have an initial, six month and annual competency check". Further reviewed stated: "v. Compete assessment will include but is not limited to the following elements: 1. Direct observation of routine patient test performance, including patient preparation (if applicable), specimen handling, processing, and testing. 2. Monitoring the recording and reporting of test results. 3. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative maintenance records. 4. Direct observation of performance of instrument maintenance and function checks. 5. Assessment of test performance through testing previously analyzed specimens, internal blinc testing samples or external proficiency testing samples. 6. Assessment of problem solving skills." 2. Review of competency assessment records showed no documentation of annual competency assessment for staff B and staff C in 2023 to include all six elements. 3. Interview with staff A on June 26, 2024, at 9:50 AM confirmed the laboratory did not follow their written policies for competency assessment. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on surveyor review of American Proficiency Institute (API) proficiency testing (PT) records and interview with the regional director, staff A, the laboratory failed to document evaluation and verification activities related to

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and the Centers for Medicare and Medicaid Services (CMS) Form CMS-116 submitted by the laboratory and interview with testing personnel, the laboratory kept none of the urine microscopic intermediate test records for the 1,613 microscopic examinations testing personnel performed annually. Findings include: 1. Review of laboratory records showed no evidence of patient test records other than the test report in the electronic medical record (EMR). 2. Review of Form CMS-116 "Clinical Laboratory Improvement Amendments (CLIA) Application for Certification", Section VIII, Non-Waived Testing, showed the laboratory performed 1,613 non-waived urinalysis tests annually. 3. Interview with testing personnel (staff A) on July 6, 2022 at 1:15 PM revealed testing personnel recorded microscopic test results on the printout from the CLINITEK Status analyzer and confirmed testing personnel discarded the printouts with patient test records after entering the results into the EMR. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on surveyor review of the "Quality Assurance Program" procedure and interview with the clinic manager, the laboratory director did not maintain the quality assurance program since 2010. Findings include: 1. Review of the "Quality Assurance Program" procedure showed the director approved the procedure on March 3, 2010. Further review showed the procedure referenced an accrediting agency (COLA) and identified responsibilities of a Point-of-Care coordinator. Additionally, the procedure included a list of thirteen analyzers and tests. The cover sheet with the procedure showed the procedure was not revised since it was approved. 2. Review of laboratory records showed: COLA, Inc had not accredited the laboratory since December 19, 2019. Competence of testing personnel had not been evaluated as required in the procedure. See D6046. Evidence of review of laboratory records by a POCT Coordinator was not present. The laboratory performed only urine macroscopic & dipstick testing and microscopic analysis. 3. E-mail correspondence with the clinic manager (staff G) on July 21, 2022 at 12:12 PM confirmed the policy did not appear to be current. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on surveyor review of Form CMS-209 (Centers for Medicare and Medicaid Services) and laboratory records and interview with the clinic manager, the laboratory director did not ensure five of five new testing personnel who performed non-waived testing at this location prior to July 6, 2022 had received appropriate training and had demonstrated they could perform urine microscopic evaluations reliably to provide and report accurate results. Findings include: 1. Review of Form CMS-209 "Laboratory Personnel Report (CLIA)" signed by the laboratory director on June 28, 2022 and submitted for this survey showed six new testing personnel. 2. Review of laboratory records showed no training records or evidence that new testing personnel had demonstrated their ability to perform accurate and reliable testing prior to testing patient samples. 3. Interview with the clinic manager (staff G) on July 6, 2022 at 1:10 PM revealed only five of the six new testing personnel listed on Form CMS-209 independently performed testing as of July 6, 2022. Further interview confirmed there was no documentation of training for the five new testing personnel. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of -- 2 of 4 -- 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 surveyor review of laboratory records and interview with the clinic manager, the technical consultant did not evaluate competency of six of six testing personnel to ensure staff maintained competence to perform microscopic urinalysis evaluations. Findings include: 1. Review of personnel records showed completion of a MedTraining Online Urine Sediment module by staff A on October 8, 2020. No other evidence of evaluation of competence in performing urine microscopic analysis during 2021 or 2022 is available for any of the six testing personnel (staff A, B, C, D, E, and F) who perform microscopic urinalysis evaluations. 2. Interview with the clinic manager (staff G) on July 7, 2022 at 1:00 PM confirmed the technical consultant had not completed competence evaluations for testing personnel that performed microscopic urinalysis in 2021 or 2022. D6070 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(1) Each individual performing moderate complexity testing must follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory procedures and proficiency testing (PT) records from 2021 through 2022 and interview with testing personnel and the clinic manager, testing personnel did not follow the laboratory's procedures for testing proficiency samples for four of four events reviewed. Findings include: 1. The "Proficiency Testing" procedure included, "For each survey, a "PROFICIENCY TESTING TRACKING FORM" is completed", and the "Proficiency Testing