Michigan Healthcare Professionals P C

Summary Statement of Deficiencies 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 record review and interview with the Medical Assistant (MA), the laboratory failed to indicate the laboratory location on the patient test report for 8 of 8 patients reviewed. Findings include: 1. A record review of patient test reports revealed the name and address of the laboratory was not listed for the following reports: a. Patient 1: 04/30/2025 b. Patient 2: 12/31/2024 c. Patient 3: 09/30/2024 d. Patient 4: 06 /28/2024 e. Patient 5: 02/29/2025 f. Patient 6: 11/30/2023 g. Patient 7: 08/31/2023 h. Patient 8: 06/30/2023 2. An interview on 05/15/2025 at 11:23 am with the MA confirmed the location of the laboratory was not listed on the patient test reports. 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 D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: . Based on record review, lack of documentation, and interview with Testing Personnel (TP) #1, the laboratory failed to perform and document the hematology Beckman Coulter DxH 520 series hematology analyzer maintenance for 7 (August 23, 2022, to 3/28/2023) of 7 months the new instrument was put into use. Findings include: 1. Record review of the Beckman Coulter DxH520 Operator's Manual revealed a "DxH 520 Instrument Maintenance Checklist." 2. Record review of all monthly tasks revealed a lack of documentation for the Beckman Coulter DxH 520 instrument maintenance for 7 of 7 months the new instrument was put into use. 3. On 3 /28/2023 at 10:42 am when queried, TP#1 was unable to provide the surveyor documentation for the required daily, monthly, and as needed maintenance. 4. An interview on 3/28/2023 at 10:42 am, TP#1 confirmed the laboratory did not perform and document the required maintenance by the manufacturer. 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 D5777 COMPARISON OF TEST RESULTS CFR(s): 493.1281(b)(c) (b) The laboratory must have a system to identify and assess patient test results that appear inconsistent with the following relevant criteria, when available: (b)(1) Patient age. (b)(2) Sex. (b)(3) Diagnosis or pertinent clinical data. (b)(4) Distribution of patient test results. (b)(5) Relationship with other test parameters. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: . Based on record review and interview with testing personnel #1 (TP1), the laboratory failed to document the comparison studies for the sampling of the patient specimen in the open mode versus the closed mode methods on the Beckman Coulter Act diff 2 hematology analyzer for three (2nd six months in 2017 and 2018) of four twice a year comparisons. Findings included: 1. Record review revealed the laboratory lacked the documentation to show the comparison studies were performed and documented twice a year for the following: a. 2nd comparison in 2017 b. 1st and 2nd comparisons in 2018 2. During the interview on August 19, 2019 at 10:15 a.m., TP1 confirmed the laboratory failed to perform and document the comparison studies twice a year. 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 --