Michigan Healthcare Professionals, P C

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 record review and interviews, the laboratory failed to have proficiency testing samples tested by personnel who routinely perform patient testing for five (M1 2024, M2 2024, M3 2024, M1 2025, M2 2025) of five events performed in 2024 and 2025 reviewed. Findings include: 1. An interview on 6/2/25 at 9:52 am with testing personnel #3 (TP3) revealed they had been working at the laboratory for the previous six years. When queried about who performs testing of the proficiency testing specimens, TP3 indicated that TP1 performs all proficiency testing including the testing of the samples and entering the results. TP3 confirmed they had never performed proficiency testing. 2. A review of the laboratory's American Association of Bioanalysis Medical Laboratory Evaluation (AAB-MLE) proficiency testing documentation revealed the following events were performed by testing personnel #1 (TP1) or testing personnel #2 (TP2): a. 2024 AAB-MLE M1 2024, submitted 2/23/24, had hematology, blood gases and chemistry events performed by TP2. b. 2024 AAB- MLE M2 2024, submitted 5/31/24, had hematology, blood gases and chemistry events performed by TP1. c. 2024 AAB-MLE M3 2024, submitted 9/27/24, had hematology, blood gases and chemistry events performed by TP2. d. 2025 AAB-MLE M1 2025, submitted 2/18/25, had hematology, blood gases and chemistry events performed by TP1. e. 2025 AAB-MLE M2 2025, submitted 5/23/25, had hematology, blood gases and chemistry events performed by TP1. 3. An interview on 6/2/25 at 12:05 pm with TP1 revealed TP1's duties include overseeing all laboratory departments and testing personnel in the organization. When queried about how often TP1 performs patient 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 -- testing, TP1 stated, "not on a regular basis." When queried about how often TP2, who serves as the manager for the office, performs patient testing, TP1 indicated TP2 is not regularly scheduled to perform testing in the laboratory and that they may perform testing "maybe once or twice a year." -- 2 of 2 --

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 observation and interview with the Technical Consultant (TC), the laboratory failed to retain the chemistry quality control documents stored in the Nova Biochemical CCX instrument that is no longer in use for 2 (June 2019 to June 2021) of 2 years. Findings include: 1. During an observation of the Nova Biochemical CCX instrument, the laboratory was not able to bring the instrument to a working capacity. 2. When queried on 6/29/2021 at 12:30 pm, the TC was not able to provide the surveyor quality control records for 3 (#1 - #3) of 12 patient chemistry testing results as follows: a. #1 - performed on 7/17/2019 b. #2 - performed on 9/04/2019 c. #3 - performed on 11/19/2019 3. An interview on 6/29/2021 at 12:30 pm, the TC confirmed the quality control records were not maintained for 2 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 1 --

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 record review and interview with the Technical Consultant (TC), the laboratory failed to retain the daily hematology Beckman Coulter AcT 5diff CP instrument background count records for 2 (June 2017 to June 2019) of 2 years reviewed. Findings include: 1. Record review revealed the daily background counts were not maintained for 2 years as follows: a. Patient testing on 6/14/17 b. Patient testing on 9/22/17 c. Patient testing on 12/28/17 d. Patient testing on 2/22/18 e. Patient testing on 4/13/18 2. During the interview on 6/12/19 at approximately 11:00 am, TC acknowledged the background counts were not saved and the Beckman Coulter AcT 5diff CP instrument would not retrieve background counts back 2 years. 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. 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 record review and interview with the Technical Consultant (TC) and Testing Personnel #1 (TP1), the laboratory failed to perform quality control as required for the chemistry testing for 2 (medical record number 1043667 and 1042070) of 10 patient charts audited. Findings include: 1. Review of the chemistry quality control records for 2 of 10 patient charts reviewed revealed 2 levels of acceptable control material was not performed and documented prior to patient testing as follows: a. Patient 1043667 performed on 4/13/18 1. chloride testing - controls #4 and #5 failed out of two controls (#4 and #5) 2. Approximately 42 patients were run on 4/13/18 b. Patient 1042070 performed on 1/11/19 1. Total bilirubin testing - controls #7 and #8 failed out of three controls (#7, #8, and #9) 2. Approximately 47 patients were run on 1/11/19 2. During the interview on 6/12/19, 2019 at 12:00 pm, TC and TP1 acknowledged 2 different levels of external controls were not acceptable on the day of testing prior to testing and reporting patient specimens. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: . Based on record review, procedure review, and interview with the Technical Consultant (TC) and Testing Personnel #1 (TP1), the laboratory failed to provide accurate and reliable patient test reports for 1 ("Patient ID" 1039600) of 10 patient charts audited. Findings include: 1. Record review of patient final test reports revealed the laboratory reported multiple (3) results for a complete blood cell count (CBC) on patient 1039600 collected on 6/02/19. 2. On 6/12/19 at approximately 1:31 pm when queried, TP1 stated that "all laboratory testing is generated across the interface and reported into the patient's electronic medical record (EMR)." 3. During the interview on 6/12/19 at approximately 1:31 pm, TP1 acknowledged that all patient testing is generated across the interface into the EMR system and no policy has been established or implemented to prevent multiple results from crossing into the EMR system. -- 2 of 2 --