Corewell Health Beaumont Troy Hospital

Summary Statement of Deficiencies D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Consultant, the laboratory failed to ensure reference intervals for its Complete Blood Count testing were available to patients viewing their test results via the patient portal for 17 (May 2022 to October 2023) of 17 months reviewed. Findings include: 1. A review of patient test reports from May 2022 to October 2023 revealed patients lacked reference intervals for their Complete Blood Count testing on their test reports entered into the laboratory's electronic medical record. 2. An interview on 10/17/23 at 11:00 am with the Technical Consultant revealed the providers use the test report generated from the hematology analyzer and the results entered in the electronic medical record are there to be sent to the patient portal. The Technical Consultant confirmed the results given to patients in the patient portal lacked reference intervals. 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 and interview with the Technical Consultant (TC), the laboratory failed to perform and document the semi-annual Sysmex Emerald hematology analyzer maintenance for 1 (2020) of 2 years reviewed. Findings include: 1. A record review of the monthly Sysmex Emerald hematology analyzer "Maintenance Log" revealed for 1 (2020) of 2 years reviewed there was a lack of documentation. 2. When queried on 2/07/2022 at 10:16, the TC was unable to provide the surveyor the documentation requested. 3. An interview on 2/07/2022 at 10:16 am, the TC confirmed the laboratory failed to perform and document the semi-annual lubricate the pistons for the Sysmex Emerald hematology analyzer in 2020. ***Repeat Deficiency from the 8/29/2017 survey*** 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 D5803 TEST REPORT CFR(s): 493.1291(b) Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Consultant #1 (TC1), the laboratory failed to ensure 1) for 1 (#9) of 11 patient charts audited the manually resulted complete blood cell (CBC) and 2) for 3 (#4, #9, and #11) of 11 patient charts audited the scanned hematology instrument printout was available in the patient's electronic medical record (EMR). Finding include: 1. Record review revealed the following results were not available in the EMR system and available to the surveyor on the day of the survey: a. 1 (#9) of 11 patient charts audited - the manually entered CBC results were not in the EMR system. b. 3 (#4, #9, and #11) of 11 patient charts audited - the scanned CBC instrument printout were not in the EMR system. 2. During the interview on 11/26/19 at 11:10 am, TC1 acknowledged the final manually entered and scanned CBC results were not in the EMR system. 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 --