Madison Medical Affiliates, Inc

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 surveyor review of laboratory records and interview with the regional director, staff A, the laboratory did not verify the accuracy of potassium hydroxide (KOH) testing for two of two events in 2023. Findings include: 1. Review of laboratory records showed no evidence of twice annual accuracy checks of KOH testing in 2023. 2. Interview with the staff A on September 13, 2024, at 11:25 AM confirmed the laboratory had not verified the accuracy of the KOH test twice annually in 2023. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation of reagents, review of laboratory records and interview with the regional director, staff A, the laboratory used expired reagents to perform potassium hydroxide (KOH) testing for eleven of thirteen patients tested in 2024. Findings include: 1. Observation of KOH reagent on September 13, 2024, at 11:05 AM showed 10 vials of Microbiologics KOH 10% 2.4 milliliter bottles, Lot# 23032302, expiration date 01/31/2024, available for patient testing 2. Review of patient testing logs showed 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 -- eleven KOH patient tests had been performed between February 1, 2024 and August 20, 2024. 3. Interview with the staff A on September 13, 2024, at 11:15 AM confirmed the laboratory used expired reagents to perform KOH testing. 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 surveyor review of testing personnel competency records and laboratory records and interview with the regional director, staff A, the technical consultant did not perform a semiannual evaluation of the performance for one of one new testing personnel during the first year the individual performed patient testing. Findings include: 1. Review of testing personnel competency records for staff B showed initial competency on September 12, 2023, for potassium hydroxide (KOH) testing. Further review showed no documentation of a semiannual competency evaluation. 2. Review of the KOH patient testing log showed staff B had performed KOH testing between September 12, 2023 and September 13, 2024. 3. Interview with staff A on September 13, 2024, at 10:08 AM confirmed the technical consultant did not perform a semiannual evaluation of the performance for one of one new testing personnel during the first year the individual performed patient testing. 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 surveyor review of new employee training records and interview with the regional director, staff A, the technical supervisor did not document initial training and competency for one of one new testing personnel who performs high complexity testing in the Mohs laboratory. Finding include: 1. Review of new employee training records showed no documentation of initial training and competency for staff C. 2. Interview with staff A on September 13, 2024, at 10:08 AM confirmed staff C had performed high complexity laboratory testing and the technical supervisor did not document initial training and competency for testing personnel. -- 2 of 2 --

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 the submitted Centers for Medicare and Medicaid Services (CMS) Form 116 Application for Certification, laboratory procedures, and interview with the Assistant Director Operations, the procedure for evaluating testing personnel competence does not address competence evaluation for testing personnel performing potassium hydroxide (KOH) testing in one of the two specialty areas of testing. Findings include: 1. Review of the CMS Form 116 submitted for the survey showed the laboratory performed PPM (provider performed microscopy) testing and showed the laboratory performed testing in Microbiology and Pathology. 2. Review of laboratory procedures for competence evaluation showed the procedures addressed testing performed in the Pathology specialty. The procedure did not address evaluation of providers performing KOH testing. 3. Interview with the Assistant Director Operations (staff A) on February 24, 2023 at 3:20 PM confirmed the laboratory had not established procedures to evaluate competence of providers who performed KOH testing. 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. 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 -- This STANDARD is not met as evidenced by: Based on surveyor review of laboratory procedures and interview with the Assistant Director Operations, the laboratory did not have a procedure for potassium hydroxide (KOH) testing, one of two test systems performed in the laboratory. Findings include: 1. Review of the laboratory procedure manual showed no evidence of a procedure for KOH testing. 2. Interview with the Assistant Director Operations (staff A) on February 24, 2023 at 3:20 PM confirmed the laboratory did not have a procedure in place for KOH testing. 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)