Summary:
Summary Statement of Deficiencies D5433 Based on review of laboratory documents and laboratory personnel interview, the laboratory failed to perform microscope maintenance once per year according to the established maintenance protocol for two of two laboratory documents reviewed. Findings include: 1. Review of maintenance documentation titled, "Microscope Maintenance Log 2022.07" shows that microscope maintenance was performed on 09- 02-20 and 06-27-22. The document did not contain a microscope maintenance entry for the 2021 calendar year. 2. Review of document tilted, "Procedure for Dermatopathology Slide Interpretation 2022.07-RLB-POT 001" states the following under item 5-Microscope Maintenance, "Microscope maintenance will be performed once a year by the technician from Biomedical Maintenance Service, Institut Curie, or by a technician from the manufacturer, or by a certified technical service hired by the Director. The date and maintenance activity will be recorded on the Microscope Maintenance Log." 3. Laboratory personnel, RB, in an e-mail communication dated August 30, 2022 at 06:52 AM, stated the following, "Microscope maintenance was not performed once each year as written in the procedure manual. The routine maintenance in Institut Curie was approximately every two years." D5805 Based on review of laboratory documents and laboratory personnel interview, the laboratory failed to include the address of the laboratory location where testing is performed for 7 of 7 laboratory documents reviewed. Findings include: 1. Review of the CLIA Laboratory Improvement Amendments (CLIA) Application for Certification (CMS-116) dated 07/31/2022, under Section 1-General Information, Facility Address, lists a facility address as follows: Department of Translational Research Institut Curie 26 rue d'Ulm Paris France, 75005 2. Review of 6 of 6 patient laboratory test reports contains the following laboratory address: RAYMOND BARNHILL CONSULTATION SERVICE PROFESSOR OF PATHOLOGY INSTITUT CURIE PARIS, FRANCE 3. Laboratory personnel, RB, in an e-mail communication dated August 30, 2022 at 06:52 AM, stated the following, "It is correct that 26 rue d'Ulm was not listed as part of the physical laboratory address on these six 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 --