Summary:
Summary Statement of Deficiencies D0000 Entrance and exit conferences were held with the laboratory representative. The survey process was discussed and survey forms were provided. An opportunity for questions and comments was given. Noted deficiency and plans of correction were discussed with the laboratory representative at the exit conference. The facility representative was given an opportunity to provide evidence of compliance with the noted deficiency, 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 staff interview and review of the laboratory records from 2018 and 2019, it was revealed the laboratory failed to have documentation of performing twice annual accuracy assessments for histopathology slide interpretations for 2018 and 2019. Findings include: 1. In an interview on 01/21/2019 at 1000 hours in the breakroom, the facility Practice Manager explained that the laboratory did NOT perform any sort of specimen processing or staining. Patient specimens were submitted to a reference laboratory for processing, staining, and evaluation. Results were digitally transmitted back to the facility. These results included a diagnosis and a digital image of the prepared slide. The facility laboratory director reviewed the digital image of the slide. 2. Review of laboratory records from 2018 and 2019 revealed the laboratory failed to have documentation of performing twice annual accuracy assessments for histopathlogy slide interpretations. The laboratory was asked to provide documentation of twice annual accuracy assessment. No documentation was provided. This confirmed the 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 --