Corewell Health W Beaumont Univ Hosp

Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on record review and an interview with the Technical Consultant (TC), the laboratory failed to perform and document maintenance for the hematology analyzer for 18 (August 2023 - January 2025) of 24 months reviewed. Findings include: 1. A record review of the laboratory maintenance records for the Beckman Coulter DxH 520 hematology analyzer revealed that documentation for maintenance was not present for 18 months (August 2023 - January 2025). 2. A review of the Beckman Coulter CxH 520 product manual revealed the Beckman Coulter DxH 520 hematology '.... requires daily, weekly, and periodic maintenance to ensure optimal performance and accurate results." 3. An interview conducted on July 9, 2025, at 11: 30 am with the Technical Consultant (TC) in which the surveyor requested the laboratory's Beckman Coulter DxH 520 maintenance records from August 2023 to July 2025 and the TC confirmed that maintenance records for the hematology analyzer were not available for the period in question. 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 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 and interview with the Technical Consultant (TC), the laboratory failed to establish a system to ensure the manually transcribed hematology complete blood cell count (CBC) test values were accurately entered into the patient's electronic medical record (EMR) system for 4 (2596607, 7022389,1554825, and 233007) of 10 patient charts audited. Findings include: 1. Record review revealed for 4 of 10 patient charts audited the manually transcribed results for the CBC did not match the instrument generated report as follows: a. 2596607 i. Absolute (Abs) Lymphocytes a. instrument report - 1.09 b. manually transcribed - 18.54. ii. Abs Monocytes a. instrument report - 0.55 b. manually transcribed - 9.29. iii. Abs Granulocytes a. instrument report - 4.14 b. manually transcribed - 70.12. iv. Lymphocytes a. instrument report - 18.54 b. manually transcribed - 1.09. v. Monocytes a. instrument report - 9.29 b. manually transcribed - 0.55. vi. Granulocytes a. instrument report - 70.12 b. manually transcribed - 4.14. b. 7022389 i. Absolute Lymphocytes a. instrument report - 0.93 b. manually transcribed - nothing reported. ii. Abs Monocytes a. instrument report - 0.65 b. manually transcribed - nothing reported. iii. Abs Granulocytes a. instrument report - 4.12 b. manually transcribed - nothing reported. iv. Lymphocytes a. instrument report - 15.35 b. manually transcribed - 0.93. 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 -- v. Monocytes a. instrument report - 10.74 b. manually transcribed - 0.65. vi. Granulocytes a. instrument report - 68.22 b. manually transcribed - nothing reported. vii. Hemoglobin a. instrument report - 10.66 b. manually transcribed - 34.6. c. 1554825 i. Absolute Granulocytes a. instrument report - 3.22 b. manually transcribed - nothing reported. ii. Monocytes a. instrument report - 7.61 b. manually transcribed - 0.40. iii. Granulocytes a. instrument report - 61.04 b. manually transcribed - Nothing reported. d. 233007 i. instrument report - scanned into EMR ii. manually transcribed report - nothing reported. 2. An interview on 7/19/2023 at 10:38 am, the TC confirmed the transcribed results in the EMR did not match the results generated from the analyzer report and a system is not in place to monitor. -- 2 of 2 --