Madison Healthcare Services

Summary Statement of Deficiencies D0000 The Madison Healthcare Services laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F. R. part 493) upon completion of the proficiency testing desk review survey performed on June 12, 2025. The following condition-level deficiencies were cited: 493.803 Successful Participation The following standard-level deficiencies were cited: 493.863 Compatibility testing . . 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) reports from the Center for Medicare and Medicaid Services (CMS) and the American Proficiency Institute (API), the 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 -- laboratory failed to successfully participate in Compatibility Testing PT under specialty of Immunohematology in 2024 and 2025. Findings are as follows: 1. The CMS CASPER Report 0155D and the API 2024 Immunohematology/Immunology - 2nd Event Performance Summary and Comparative Evaluation and the API 2025 Immunohematology/Immunology - 1st Event Performance Summary and Comparative Evaluation were reviewed on June 12, 2025. 2. The reports indicated the laboratory failed to achieve satisfactory performance for Compatibility Testing in two of three consecutive testing events from 2024 and 2025, resulting in unsuccessful performance of the analyte (see D2181). . D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) (e) Failure to achieve an overall testing event score of satisfactory for 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 proficiency testing (PT) scores from the American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance for Compatibility Testing in two out of three consecutive testing events in 2024 and 2025, constituting unsuccessful participation for the analyte. Findings are as follows: 1. API Performance Summary and Comparative Evaluation PT reports from the 2024 Immunohematology/Immunology 2nd Event and the 2025 Immunohematology /Immunology 1st Event were reviewed on June 16, 2025. 2. The reports indicated the laboratory had unsatisfactory performance for Compatibility Testing in two out of three consecutive events, leading to unsuccessful participation. See below. Unsatisfactory Compatibility Testing PT Events: Event Score 2024 2nd Event 80% 2025 1st Event 80% . -- 2 of 2 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to follow the established quality control (QC) requirements in the Profile-V MEDTOXScan procedure in 2022, 2023, and 2024. Findings are as follows: 1. The laboratory performed moderate complexity Urine Drugs of Abuse testing which falls under the sub-specialty of Toxicology under the specialty of Chemistry testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 11:55 a.m. on April 10, 2024. 2. A MEDTOXScan Profile-V Drugs of Abuse test system was observed as present and available for use during the tour. 3. The Profile V MEDTOXScan Positive or High Positive and MEDTOXScan Negative Control Solutions were listed as materials required but not provided by the test system in the laboratories established Profile V MEDTOXScan procedure found in PolicyStat electronic procedure manual. Section 9 of the established procedure, goes on to indicate the QC material to be used are urine-based control materials. 4. QC performance records were reviewed for the third quarter of 2022, July, August and September 2022. These records indicated the QC material used for the negative control by the laboratory was DI (distilled) water. 5. The PV MEDTOXScan 2X Pos control (lot # CC01651, Expiration Date 10-31-2021) was observed in the laboratory at 9:15 a.m. on April 11, 2024 as the positive QC material used for the MEDTOXScan Profile-V test system. A urine-based negative MEDTOXScan control was not observed. 6. During an interview at 9:15 a.m. on April 11, 2024, the GS confirmed the laboratory has used distilled water as the negative control for the previous two years. . 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 -- D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to perform minimum quality control activities as established by the manufacturer of a Chemistry test for 13 of 22 months reviewed in 2022, 2023, and 2024. Findings are as follows: 1. The laboratory performed moderate complexity Urine Drugs of Abuse testing which falls under the sub-specialty of Toxicology under the specialty of Chemistry testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 11:55 a.m. on April 10, 2024. 2. A MEDTOXScan Profile- V Drugs of Abuse test system was observed as present and available for use during the tour. 3. MEDTOXScan quality control (QC) performance was required weekly as established in the manufacturer's Profile-V MEDTOXScan Reader System Quick Reference Instructions, Revision 06/21, found in the current Test Kit used by the laboratory. 4. The laboratory's Individualized Quality Control Plan (IQCP) for the MEDTOXScan Profile -V test system established two levels of external liquid QC must be analyzer prior to using a new lot number or new shipment of cassette devices, as well as once per month. The IQCP did not include weekly QC performance, as required by the manufacturer. This IQCP had been revised in April 2023 to reduce external QC frequency from the manufacturers required weekly QC performance to monthly QC performance. 5. QC performance records indicated QC was performed weekly until May 2023, at which time the laboratory began performing two levels of external QC monthly. See below for QC dates beginning May 2023: QC date 05/01 /2023 06/01/2023 07/03/2023 08/01/2023 09/01/2023 10/01/2023 11/01/2023 12/01 /2023 01/01/2024 02/05/2024 03/01/2024 04/01/2024 6. Patient testing records indicated 152 patients had been tested on the MEDTOXScan Profile test system since the laboratory had reduced the QC frequency to once per month. 7. During an interview at 9:20 a.m. on April 11, 2024, the GS confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies 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 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)

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 a review of Center for Medicare and Medicaid Services reports and American Proficiency Institute (API) proficiency testing reports, the laboratory failed to successfully participate in proficiency testing (PT) in 2022 for Partial Pressure of Oxygen (PO2) under the specialty of Chemistry. Findings include: 1. The CASPER Report 0155D, reviewed on April 1, 2022, indicated the the laboratory failed to successfully participate in PO2 PT in 2022. Unsatisfactory PT performance in PO2 testing was obtained in the following events as verified with API proficiency testing 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 -- reports. -2021 2nd event 60% -2022 1st event 60% See D2087. 2. The CASPER Report 0155D indicated the laboratory failed to obtain a PO2 PT score of at least 80 percent in two out of three consecutive testing events in 2021 and 2022. See D2096. . D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: . Based on a review of Center for Medicare and Medicaid Services reports and American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to attain satisfactory PT scores for Partial Pressure of Oxygen (PO2) testing. Findings are as follows: 1. The laboratory failed to attain PT scores for PO2 testing of at least 80 percent in one event in 2021 and one event in 2022. Scores less than 80 percent resulted in unsatisfactory performance for the analyte. 2. API PT reports listed the following unsatisfactory PO2 scores. - 2021 2nd event: 60% - 2022 1st event: 60% . D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 review of Center for Medicare and Medicaid Services reports and American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to achieve successful PT performance for Partial Pressure of Oxygen (PO2) testing. Findings are as follows: 1. The laboratory failed to attain satisfactory PO2 PT scores in two out of three consecutive PT events. Two out of three consecutive unsatisfactory PT scores for the same analyte constituted unsuccessful performance. 2. API PT reports listed the following unsatisfactory PO2 scores. - 2021 2nd event: 60% - 2022 1st event: 60% -- 2 of 2 --

Summary Statement of Deficiencies 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 their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the Technical Supervisor (TS) failed to ensure 1 of 3 new testing personnel (TP) received documented training for microscopic examinations. In addition, the TS failed to ensure the competency assessment included a Microbiology test in 2018 and 2019. Findings are as follows: 1. The laboratory performed microscopic examinations (Fern Test, Urine Sediment, Manual Differential, Saline and Potassium Hydroxide Wet Preparation) and Throat Cultures as confirmed by the General Supervisor (GS) during a tour of the laboratory at 8:10 a.m. on 09/17/20. 2. Testing Personnel 2 (TP2) was hired and received initial training in December 2019 as indicated in laboratory records. Documentation of microscopic examination training was not found during review of TP2's personnel records. The laboratory was unable to provide the missing document upon request. 3. Competency assessment documents for 3 of 3 TP in 2018 and 4 of 4 TP in 2019 did not include an evaluation of Throat Cultures. 4. In an interview at 10:25 a.m., the Technical Consultant confirmed the above finding. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the 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 -- performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the Technical Supervisor failed to ensure 1 of 3 new testing personnel received a competency evaluation at least semiannually during the first year of patient specimen testing. Findings are as follows: 1. The laboratory performed the Fern Test and Saline and Potassium Hydroxide Wet Preparation microscopic examinations as confirmed by the General Supervisor (GS) during a tour of the laboratory at 8:10 a.m. on 09/17/20. 2. Testing Personnel 2 (TP2) was hired and received initial training in December 2019 as indicated in laboratory records. Documentation of microscopic examination training was not found in TP2's personnel records. See D6120 3. A semiannual competency assessment for the Fern Test and Saline and Potassium Hydroxide Wet Preparation microscopic examinations was not found for TP2 during review of laboratory personnel records. The laboratory was unable to provide the missing semiannual competency assessments upon request. 4. In an interview at 10:25 a.m. on 09/17/20, the Technical Consultant confirmed the above finding -- 2 of 2 --

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 a review of Center for Medicare and Medicaid Services reports and American Proficiency Institute (API) proficiency testing reports, the laboratory failed to successfully participate in proficiency testing (PT) in 2019 for Compatibility Testing under the specialty of Immunohematology. Findings include: 1. The CASPER Report 0155D, reviewed on March 9,2019, indicated the the laboratory failed to successfully participate in Compatibility Testing in 2019. Unsatisfactory PT performance in Compatibility Testing was obtained in the following events. -2019 3rd 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 -- event 60% -2019 1st event 60% 2. The CASPER Report 0155D indicated the laboratory failed to obtain a Compatibility Testing PT score of at least 100 percent in two out of three consecutive testing events in 2019. See D2173 and D2181 D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: . Based on a review of proficiency testing (PT) reports from the American Proficiency Institute (API), the laboratory failed to obtain a PT score in Compatibility Testing of at least 100 percent which resulted in unsatisfactory performance. Unsatisfactory PT performance of Compatibility Testing was obtained in the following events. -2019 1st event 60% -2019 3rd event 60% D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for 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 proficiency testing scores from the American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance for Compatibility Testing in two out of three consecutive testing events, constituting unsuccessful participation for the analyte. API results indicated the laboratory had unsatisfactory performance for Compatibility Testing in two out of three consecutive events, leading to unsuccessful participation. Unsatisfactory PT performance of Compatibility Testing was obtained in the following events. -2019 1st event 60% -2019 3rd event 60% -- 2 of 2 --