Grand River Medical Group Urgent Care Warren Plaza

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(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 review of patient test reports, hematology instrument printouts, and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 10:40 am on 04/26/2023, the laboratory failed to include all units of measure for three out of three patient test reports (patient identifiers A, B, and C) reviewed from February 2023. The findings include: 1. Patient A had a complete blood count (CBC) with automated differential performed on 02/15/2023. 2. Patient B had a CBC with automated differential performed on 02/16/2023. 3. Patient C had a CBC with automated differential performed on 02/20/2023. 4. The electronic health record (EHR) test reports for Patients A, B, and C did not include units of measure for the following CBC parameters: white blood cell count, red blood cell count, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), platelets, red blood cell distribution width (RDW-CV), absolute neutrophil count, neutrophil percentage, absolute lymphocyte count, lymphocyte percentage, absolute monocyte 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 -- count, monocyte percentage, absolute eosinophil count, eosinophil percentage, absolute basophil count, basophil percentage, absolute immature granulocyte count, and immature granulocyte percentage. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manual and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 11: 30 am on 04/26/2023, the laboratory director failed to ensure the laboratory established and maintained a quality assessment program which covered the four quality systems: general, pre-analytic, analytic, and post-analytic. At the time of the survey the laboratory did not have a written quality assessment policy/procedure which covered the four quality systems. -- 2 of 2 --

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 review of hematology instrument maintenance records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 11:00 am on 11/03/2021, the laboratory failed to document weekly maintenance for 14 out of 22 weeks and monthly maintenance for five out of five months of patient testing on the Sysmex KX-21N hematology instrument from 06/01 /2021- 10/31/2021. The findings include: 1. According to the Sysmex K-Series Maintenance Log, the manufacturer requires the laboratory to perform and document cleaning of the SRV tray weekly. 2. The Sysmex K-Series Maintenance Logs from June- October 2021 indicated that the laboratory did not document weekly maintenance during the following weeks: 06/01/2021, 06/06/2021, 06/13/2021, 06/20 /2021, 06/27/2021, 07/04/2021, 07/11/2021, 07/18/2021, 07/25/2021, 08/01/2021, 09 /26/2021, 10/03/2021, 10/10/2021, and 10/24/2021. 3. The Sysmex K-Series Maintenance Log also indicated that the manufacturer requires the laboratory to perform and document the following monthly maintenance: clean transducer and clean waste chamber. 4. The Sysmex K-Series Maintenance Logs indicated that the laboratory did not document monthly maintenance from June 2021- October 2021. 5. At the time of the survey, personnel identifier #1 confirmed that the laboratory failed to document weekly and monthly maintenance on the The Sysmex KX-21N hematology instrument as required by the manufacturer. D5805 TEST REPORT 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 -- CFR(s): 493.1291(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 review of patient test reports, instrument printouts, and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 11:00 am on 11/03/2021, the laboratory failed to include all units of measure for three out of three patient test reports reviewed (patient identifiers A, B, and C). The findings include: 1. Patient A had complete blood count (CBC) testing performed on 08/05/2021. 2. Patient B had complete blood count (CBC) testing performed on 08/12/2021. 3. Patient C had complete blood count (CBC) testing performed on 08/23/2021. 4. The electronic health record (EHR) test report for patients A, B, and C did not include units of measure for the following CBC parameters: white blood cell count, red blood cell count, hematocrit, hemoglobin, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, mean corpuscular volume, red cell distribution width, lymphocyte percentage, absolute lymphocyte count, neutrophil percentage, and absolute neutrophil count. 5. At the time of the survey, personnel identifier #1 confirmed that the EHR test reports for patients A, B, and C did not include the units of measure listed above. -- 2 of 2 --