Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Through review of proficiency testing attestation forms and interview it was determined that the laboratory director did not attest that the proficiency testing was performed in the same manner as patient testing in two of eleven events reviewed. Survey findings follow: A) Review of API proficiency testing Chemistry Core second event 2018 and API proficiency testing Chemistry Miscellaneous second event 2018 revealed the laboratory director or designee did not sign the statement attesting that testing was performed in the same manner as patient testing . B) In an interview at approximately 10:35 AM on 1/17/20, the laboratory staff member, identified as number two on the CMS 209 form, confirmed that the laboratory director or designee signature was not present on the proficiency testing events attestation identified above. 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: Through a review of the Architect c4000 and Architect i1000 Monthly Maintenance Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Logs for January 2019, March 2019, July 2019 and November 2019, lack of documentation, and interviews with laboratory staff, it was determined the laboratory failed to document maintenance with the frequency specified by the manufacturer in three of three months reviewed. Survey findings include: A) The Architect c4000 Montly Maintenance Log for March 2019, July 2019 and November 2019 has monthly maintenance requirements listed namely; "clean cuvette washer nozzles", "check syringes and valves", "clean ICT drain tip" and "check dispense components". The status record states "not performed" for all three months reviewed. . B) The Architect i1000 Monthly Maintenance Log for January March 2019, July 2019 and November 2019 has monthly maintenance requirements namely, "air filter cleaning" and the status record states "not performed" for all three months reviewed. C) Upon request the laboratory could not produce documentation that monthly maintenance had been performed on the Architect c4000 and Architect i1000 for the months identified above. D) In an interview at 4:15 p.m. on 1/16/20, the laboratorystaff member, identified as number 2 on the CMS 209 form, confirmed the lack of monthly maintenance documentation for the analyzers identified above.. D5783