Summary:
Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. . D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the review of the laboratory's records, patient results, and confirmed in an interview found the laboratory failed to perform two quantitative QC materials with different concentrations prior to patient testing for moderate complexity tests, PT /INR, for one of one Abott i-STAT. The findings were: 1. Reviewed ot the laboratory's records revealed the i-STAT (SN: 399160) currently in-use was installed on 9/15/22. 2. Reviewed the the laboratory's patient results revealed 10 patients had PT /INR testing performed on i-STAT, SN:399160 after 9/15/22. 9/19/22 Sample ID: Q00053267342 9/23/22 Sample ID: Q00053277877 9/27/22 Sample ID: Q00053287404 9/29/22 Sample ID: Q00053019024 9/29/22 Sample ID: Q00053115805 9/29/22 Sample ID: Q00053292592 10/13/22 Sample ID: Q00053334093 10/21/22 Sample ID:Q00053357932 10/25/22 Sample ID: Q00053367821 10/27/22 Sample ID:Q00053373772 3. Review of the laboratory's QC records for the above dates revealed no documentation of two quantitative QC materials with different concentrations. 4. An interviiew with the Point-of-care coordinator (POCC) on 12/13/2022 at 11:40 am in a small conference room confirmed 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 -- the above findings. Key: QC=Quality Control PT=Prothrobim time INR=International normalized ratio -- 2 of 2 --