Prohealth Medical Group, Inc -

Summary Statement of Deficiencies D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) 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, interview with the technical consultant (staff A), and email communication after the survey was completed, the laboratory director (staff B), who was fulfilling the technical consultant responsibility of performing competency assessments for testing personnel, did not perform semiannual competency assessment evaluation of testing performance for six of six new testing personnel from the class of 2024-2025 interns during the first year the individuals performed patient testing. Findings include: 1. Review of testing personnel competency records for one intern, staff C, from the 2024-2025 intern class, revealed initial competency in July 2024, and annual competency in August 2025. Further review revealed no documentation of a semiannual competency evaluation. 2. Interview with staff A on September 15, 2025, at 10:00 AM, confirmed the semiannual competency records were not available at the time of the survey for staff C, and requested one day to locate the records. 3. Review of an email staff A sent to the state agency one day after the survey, on September 16, 2025, confirmed the semiannual competency evaluation was not available for staff C and revealed the laboratory was "unable to locate the 6 month provider performed microscopy evaluations for interns in academic year 2024-2025". 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 D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on surveyor review of proficiency testing (PT) records and interview with the technical consultant, the laboratory did not evaluate one of one not scored / non- consensus result in the second testing event in 2022. Finding include: 1. Review of the Wisconsin State Laboratory of Hygiene (WSLH) PT results from the miscellaneous quality assurance point of care second event (MISC QA POC2) showed sample PM-4 for urine sediment was resulted by the laboratory as bacteria. The expected result was calcium carbonate crystals. The report showed no evidence of review by the laboratory. 2. Interview with the technical consultant on September 20, 2023, at 10:00 AM confirmed the laboratory did not review the ungraded result to verify the accuracy of the reported result. 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 D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on surveyor review of the CMS (Centers for Medicare and Medicaid Services) Form 209 Laboratory Personnel Report (CLIA) and proficiency testing records and interview with the technical consultant, thirty-two providers that routinely perform provider performed microscopy testing have not tested the proficiency samples with their regular patient workload. Findings include: 1. Review of the CMS Form 209 showed thirty-three individuals identified as testing personnel. 2. Review of proficiency testing records showed the technical consultant, who is also a testing personnel, performed all provider performed microscopy proficiency challenges in 2018 and 2019. 3. Interview with the technical consultant on September 10, 2019 at 10:30 AM confirmed thirty-three testing personnel perform microscopy testing on patient samples. Further interview confirmed the laboratory has not ensured testing personnel other than the technical consultant performed and submitted the proficiency testing challenges with their regular patient workload. 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. 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 -- This STANDARD is not met as evidenced by: Based on surveyor review of laboratory procedures and interview with the technical consultant, the laboratory has not established written policies and procedures to assess testing personnel and technical consultant competency. Findings include: 1. Review of laboratory procedures showed no evidence of a written procedure for the evaluation of testing personnel and technical consultant competency. 2. Interview with the technical consultant on September 10, 2019 at 10:00 AM confirmed the laboratory did not have a procedure for evaluation of testing personnel competency that includes evaluation of providers performing microscopy testing, laboratory testing personnel performing moderate complexity testing, and the technical consultant. -- 2 of 2 --