Healthcare Express-Midwest City

Summary Statement of Deficiencies D0000 The recertification survey was performed on 11/12/2020. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the director of laboratory operations and the technical consultant at the conclusion of the survey. 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 a review of records, manufacturer's instructions, and interview with the director of laboratory operations and the technical consultant, the laboratory failed to perform maintenance procedures as required by the manufacturer. Findings include: (1) On 11/12/2020 at 09:45 am, the director of laboratory operations stated to the surveyor CBC (Complete Blood Count) testing was performed on the Sysmex XP300 analyzer; (2) The surveyor reviewed the manufacturer's weekly maintenance requirement for the analyzer, as stated on the manufacturer's maintenance log titled "XP-300 Maintenance Log", which was: (a) Clean SRV Tray (3) Maintenance records were reviewed by the surveyor for 9 months (January 2020 through September 2020). The weekly maintenance had not been documented as performed between: (a) 08/03 /2020 and 09/01/2020 (4) The surveyor reviewed the records with the director of laboratory operations and the technical consultant. Both stated on 10/12/2020 at 11:55 am, there was no evidence the above maintenance had been performed as required. 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 D0000 The findings were reviewed with the technical consultant, director of laboratory operations, and assistant to the director of laboratory operations at the conclusion of the survey. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant and director of laboratory operations, the laboratory failed to have a policy for monitoring the effectiveness of their IQCP. Findings include: (1) At the beginning of the survey, the technical consultant stated the following to the surveyor: (a) The laboratory performed CKMB and Troponin I testing using the Quidel Triage Meter Pro analyzer; (b) An IQCP (Individualized Quality Control Plan) had been developed for the test system. (2) The surveyor reviewed the IQCP (dated as approved on 06/06/16). The QA (Quality Assessment) portion of the IQCP did not include a schedule for evaluating the QCP (Quality Control Plan) to ensure it continued to provide accurate and reliable results. There was no evidence of QA reviews since the IQCP effective date; (3) The surveyor reviewed the records with the technical consultant and director of laboratory operations, and asked if there was a policy to address how the laboratory will monitor the IQCP, including the frequency of the reviews and if QA reviews had been performed since the IQCP had been implemented. Both stated a policy had not been written and QA reviews had not been performed. 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 --