Madison Medical Urology

Summary Statement of Deficiencies D0000 An offiste revisit survey was completed on August 17, 2026, for all previous deficiencies cited at the recertification survey performed on June 22, 2026. New noncompliance was found. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory policies, and records, and email communication with the Regional Director of Clinic Operations (Staff B), the laboratory did not identify a problem in the postanalytic system during review of one of one urine microscopic test reports when it was performing chart reviews based on the written quality assessment policy. Findings include: 1. Review of the 'Quality Assurance Program' procedure showed in section C, that the laboratory performed a post analytical review of the patient result report and medical record as follows: "C. Post Analytical 1. Result report contains the following a. Name of test b. Result, units of measure, and reference range c. ID of person performing the test d. Patient names and unique identifier e. Lab name and address f. Date time of specimen collection, receipt and completion g. If applicable, documentation of notification of critical results. This includes who was contacted, date, time, and person performing the notification. Critical values are reported to the ordering Physician, NP, PA, or RN as applicable. 2. Chart review will be accomplished per rotation schedule. a. Requisition present i. Patient name ii. Patient ID iii. Test requested b. Medical record i. Written order for specific test ii. When to perform c. Quality control performed d. Person performing test current with competency e. Result present in medical record i. Patient name ii. Patient ID iii. Result iv. Reference range v. ID person who performed the test 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 -- vi. Specimen collect time vii. Specimen receive time viii. Test completed time ix. Critical value/notification documentation" 2. Review of form, 'Quality Assurance Program Audit Log' provided as evidence for D6020 cited during the laboratory's recertification survey, showed the laboratory reviewed four patient records and findings stated, "Meets QA documentation". A review of the urine microscopic test report provided for Patient 2 showed the following components were missing: -The unit of measure for bacteria, mucus, amorphous elements, -The reference ranges for all urine microscopic components, -The date and time of specimen receipt. 3. The State Agency received an email communication from Staff B on August 11, 2026, at 1: 42 PM confirming that "when performing audits, we are looking for the documentation to include items listed in section C 1 and 2. There is a known deficiency as identified in D5787 where the lab address is incorrect, which is still in the process of being rectified." -- 2 of 2 --

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. 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 of Clinic Operations (Staff A), the laboratory did not review and evaluate the results obtained on proficiency testing performed for two of the last six proficiency testing events. Findings include: 1. Review of API PT records showed the laboratory received PT reports for the following events: 2026 Hematology/Coagulation-1st Event 2025 Hematology /Coagulation-3rd Event 2025 Hematology/Coagulation-2nd Event 2025 Hematology /Coagulation-1st Event 2024 Hematology/Coagulation-3rd Event 2024 Hematology /Coagulation-2nd Event Review of the reports for the 2025 Hematology/Coagulation- 3rd Event and 2025 Hematology/Coagulation-2nd Events showed no evidence the laboratory reviewed and evaluated results for the two events. 2. Interview with Staff A on June 22, 2024 at 1:50 confirmed the laboratory did not document review and evaluation of PT results for the two events. This is a repeat deficiency previously cited on June 26, 2024. D5787 TEST RECORDS CFR(s): 493.1283(a) (a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel 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 -- who performed the test(s). This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with the Regional Director of Clinic Operations (Staff A), the laboratory did not maintain a record system that included the date and time of sample receipt into the laboratory and date and time of sample testing for one of one record reviewed for a patient's urine microscopy test that was reflexed based on the urine macroscopic results. Findings include: 1a. Review of the instrument printout from the Siemens Clinitek Status analyzer for Patient 1 showed the test time for the urine macroscopic test was 12:00 PM. The printout contained handwritten results for the urine microscopic test. Further review of records showed no indication of the date and time of specimen receipt into the laboratory. Further review showed no indication the time the microscopic test was performed. 1b. Review of the patient test report in the electronic medical record, EPIC, showed the clinic collected the urine at 11:25 AM. Further review showed the laboratory resulted the urine macroscopic and microscopic result at 11:25 AM. 2. Interview with Staff A on June 22, 2026, at 3:10 PM confirmed the time on the instrument printout was different from the electronic medical record for the urine macroscopic test and the laboratory did not maintain record of the time of the urine microscopic test. Further interview confirmed the laboratory failed to maintain record systems to document date and time of specimen receipt into the laboratory and records to identify the date and time the laboratory performed the urine microscopic test. D5805 TEST REPORT CFR(s): 493.1291(c) (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 surveyor review of one of one urine microscopic patient test reports in the electronic medical record (EMR) and interview with the Regional Director of Clinic Operations (Staff A), the test report did not indicate the correct name and address of the laboratory location where the test was performed. Findings include: 1a. A urine microscopic test report for Patient 1 showed the Resulting Agency was listed as: "A TEST CLINIC". 2. Interview with Staff A on June 22, 2026, at 3:10 PM confirmed the testing was performed at the surveyed laboratory and that the test report did not indicate the name and address of the laboratory. This is a repeat deficiency previously cited on June 26, 2024 and July 6, 2022. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify -- 2 of 3 -- failures in quality as they occur; This STANDARD is not met as evidenced by: Based on surveyor review of laboratory procedures and records, and interview with the Regional Director of Clinic Operations (Staff A), the laboratory director did not ensure that the one of one quality assessment program was maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. Findings include: 1. Review of the laboratory's 'Quality Assurance Program' approved by the laboratory director on July 29, 2022, revealed, in part, the laboratory performed a post analytical review of the result report, and a chart review. Further review indicated the laboratory monitored specific quality assurance markers. The program document stated, "The records of our quality assurance activities are filed with this plan and are available for review." 2. Review of the laboratory's records revealed no evidence of documentation of the elements described in the quality assurance program. 3. Interview with Staff A on June 22, 2026, at 1:55 PM confirmed the quality assurance program records were not available, confirming the laboratory director did not ensure maintenance of the quality assessment program to assure the quality of laboratory services provided. D6071 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(2) (b)(2) Maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient samples; This STANDARD is not met as evidenced by: Based on surveyor review of proficiency testing (PT) records and interview with the Regional Director of Clinic Operations (Staff A), testing personnel did not maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient samples for two of two PT events reviewed in 2025. Findings include: 1. Review of the PT records for 2025 Hematology/Coagulation - first event and third event revealed form, 'American Proficiency Institute Attestation Statement,' stating, "The undersigned certify that, as closely as possible, these proficiency testing samples were tested in the same manner as patient specimens." The laboratory director and two testing personnel signed and dated each of the forms. The form included a line "Sample Set(s) Tested" for testing personnel to record the samples tested. This line was blank. Further review of the records showed no indication of which testing personnel performed the urine microscopic portion of the proficiency testing for the two events. 2. Interview with Staff A on June 22, 2026, at 1:50 PM confirmed the personnel performing the urine microscopic testing could not be determined from the PT records. -- 3 of 3 --

Summary Statement of Deficiencies 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 one of one 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 in 2023 to include all six elements. 3. Interview with staff A on June 26, 2024, at 1:15 PM confirmed the laboratory did not follow their written policies for competency assessment. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) 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 -- The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. 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 did not review and evaluate the results obtained on proficiency testing performed for four of six events reviewed. Findings include: 1. Review of API PT records show the no documentation of review and evaluatation of PT results for the following events: 2022 Hematology/Coagulation-3rd Event 2023 Hematology/Coagulation-2nd Event and 3rd Event 2024 Hematology/Coagulation-1st Event 2. Interview with staff A on June 26, 2024 at 1:18 PM confirmed the laboratory did not review and evaluate PT results. 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 surveyor review of a urine microscopic patient test report in the electronic medical record (EMR) and interview with the regional director, staff A, the test report did not show the name and address of the laboratory where the test was performed for two of two patients reviewed. Findings include: 1. Review of the urine microscopic test report for patient 1 and patient 2 in the EMR showed no evidence of the location of testing. The only location reference was to "a test clinic". 2. Interview with staff A on June 26, 2024, at 1:20 PM confirmed the test report did not show the name and address of the laboratory. This is a repeat deficiency from July 6, 2022. 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 survey review of laboratory procedures and patient urinalysis test reports and interview with the regional director, staff A, the reference ranges were not available to authorized personnel who ordered the test for two of two patient reviewed. Findings include: 1. Review of the "PPM-Microscopic Urinalysis Examination (POC)" procedure showed the approved reference ranges to include: "A. Red Blood Cell (RBC): 0-2/high powered field (hpf) B. White Blood Cell (WBC): 0.5 /hpf C. Bacteria: None Seen D. Epithelial Cells: None-Few E. Mucus: None-Present -- 2 of 3 -- F. Amorphous Crystals: None-Present G. Hyaline Cast: 0.1/low power field (lpf) H. Other elements: None seen." 2. Review of patient 1 and patient 2 in the Electronic Health Record (EHR) showed no reference ranges listed on the report. 3. Interview with staff A on June 26, 2024, at 1:20 PM confirmed the reference ranges for urine microscopic results were not available to authorized personnel in the EHR. 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 competency assessment records and interview with the regional director, staff A, the technical consultant did not document competency assessment for one of one testing personnel responsible for urine microscopy testing in the laboratory in 2023. Findings include: 1. Review of competency assessments for the laboratory showed no documentation of competency assessment for urine microscopy testing in the laboratory for 2023. 2. Interview with staff A on June 26, 2024, at 1:15 PM, confirmed the technical consultant did not document competency assessment for testing personnel performing urine microscopy testing in 2023. This is a repeat deficiency from July 6, 2022 -- 3 of 3 --

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 retained none of the urine microscopic intermediate test records for the 1,204 microscopic examinations testing personnel performed in 2021. 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 1,204 non-waived urinalysis tests in 2021. 3. Interview with testing personnel (staff A) on July 6, 2022 at 10:35 AM 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. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)