Summary:
Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) 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 the lack of Maintenance Records (MR) for the Linistat Linear Stainer (LLS), surveyor review of the LLS operators guide and interview with the General Manager (GM), the laboratory failed to perform and document maintenance defined by the manufacturer for the LLS used for Histopathology tests from 3/11/24 to 2/19/25. The findings include: 1. There was no documented evidence maintenance was performed on the LLS. 2. The GM confirmed on 2/19/25 at 1:45 pm, there were no MR available for review for the LLS. D6173 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495 The testing personnel are responsible for specimen processing, test performance and for reporting test results. This STANDARD is not met as evidenced by: Based on surveyor review of Mohs Maps (MM), Electronic Medical Records (EMR) and interview with General Manager (GM), Testing Personnel (TP) failed to document accurate test results for Histopathology tests from 1/30/25 to 2/19/25. The finding includes: 1. The MM for case number R25-74 performed on 1/30/25 did not have a documented Pre Op or Post Op sizes on the MM. 2. The EMR stated a Pre-op 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 -- size of 1 cm x 0.8 cm and a final defect size of 1.4 cm x 1.1 cm 3. The MM and EMR for case number R25-74 did not correlate. 4. The GM confirmed on 2/19/25 at 1:50 pm, TP did not document accurate Histopathology test results. -- 2 of 2 --