Summary:
Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) record review and an interview with the laboratory director and technical consultant, the laboratory failed to retain instrument data from the Beckman Coulter AU 480 chemistry analyzer and the Stago prothrombin time instrument for the American Proficiency Institute (API) events in 2017 and 2018. Findings: 1. An API record review revealed the laboratory failed to retain the AU480 chemistry analyzer data printouts for the API chemistry 2017 events 2 and 3 and 2018 events 1 and 2. 2. An API record review revealed the laboratory failed to retain the Stago prothrombin time instrument data printout for the API hematology 2018 event 1. 3. An interview on June 12, 2018 at 8:00 AM, with the laboratory director and technical consultant, confirmed the instrument printouts for proficiency testing in chemistry and prothrombin time were not retained with the proficiency testing records. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. 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 -- This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory director and technical consultant, the laboratory failed to establish and document a maintenance program for scheduled and unscheduled maintenance activities for the Beckman Coulter AU 480 chemistry analyzer, Stago prothrombin time instrument, and the Beckman Coulter AcT Diff 2 since the last survey on August 8, 2016. Findings: 1. A record review of the laboratory maintenance records, revealed the laboratory failed to document