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 a review of the laboratory's polices, a review of the laboratory's American Society of Dermatopathology proficiency testing records from 2020, and staff interview, it was revealed the laboratory failed to have documentation of verifying the accuracy of tissue pathology (grossing) at least twice annually in 2020. Findings include: 1. A review of the laboratory's policy titled 'Quality Control' revealed the following: "This laboratory participates in the diagnostic quality control and laboratory proficiency testing service of the American Society of Dermatopathology. Our laboratory receives slides from the service to diagnose periodically. In addition, we receive tissue specimens to process according to specific techniques." 2. A review of the laboratory's American Society of Dermatopathology proficiency testing records revealed no documentation of proficiency testing being performed at least twice annually in 2020. 3. An interview with testing person #2 (as indicated on the CMS 209 form) on 3/29/21 at 9:40 a.m. in the laboratory, after review of the records, confirmed the above findings. 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 --