Summary:
Summary Statement of Deficiencies D2081 GENERAL IMMUNOLOGY CFR(s): 493.837(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on a review of laboratory American Proficiency Institute (API) proficiency testing (PT) records and an interview with Technical Consultant 1 (TC1), the laboratory failed to submit PT results to API for the 2019 Immunology 2nd testing Event within the time frame specified. Findings: 1. A review of PT records for 2019 identified an unsatisfactory performance with a result of 0% for the API 2019 Immunology 2nd testing event. 2. An interview with TC1, on 9/25/19 at approximately 9:15 AM, confirmed that the laboratory failed to return the PT results to API before the deadline for the 2019 Immunology 2nd testing Event. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a review of laboratory Proficiency Testing (PT) records and an interview with Technical Consultant 1 (TC1), the laboratory received an unsatisfactory score of 0% for Vaginal Wet Preparation in the American Proficiency Institute (API) 2018 Hematology 2nd testing event. Findings: 1. A review of 2018 API PT records identified an unsatisfactory performance of 0% for Vaginal Wet Preparation in the 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 -- 2018 Hematology 2nd testing event. For sample VA-02 the laboratory reported "clue cells seen", when the correct answer was "no yeast, Trich, or clue cells". This resulted in an unsatisfactory score of 0%. 2. An interview with TC1, on 9/25/19 at approximately 9:15 AM, confirmed the findings. 3. The laboratory took remedial action and documented the remedial action taken. -- 2 of 2 --