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 representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory procedures and laboratory records and confirmed in an interview, the laboratory failed to document at least twice annually the accuracy of 1 of 3 tests. (Mart-1 stain) Findings were: 1. Review of the laboratory procedure 2. Review of the proficiency testing records available for 2016-2018 revealed no documentation of the laboratory verifying at least twice annually the accuracy of Mart- 1 stain. 3. An interview with the laboratory director on 12/3/18 at 0940 hours in the laboratory confirmed the above findings. He acknowledged that the laboratory should include the Mart-1 stain for their proficiency testing. 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 --