Summary:
Summary Statement of Deficiencies D2044 MYCOLOGY CFR(s): 493.827(d) (1) For any unsatisfactory testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) Remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Through a review of API (American Proficiency Institute) proficiency test documentation for 2017, a review of the technical consultant reports for 2017, lack of documentation, and interviews with staff, it was determined the laboratory failed to take remedial actions for unsatisfactory testing event scores on Vaginal Wet Prep Examinations. Survey findings follow: A. Through a review of the API Comparative Evaluation forms for the three events in 2017 it was determined the laboratory had unsatisfactory testing event scores on one of three testing events. The laboratory received a 0% score for Wet Prep Examinations on the 1st Proficiency Event of 2017. B. The technical consultant reports for 2017 failed to include documentation of the 0% Wet Prep score or any