Summary:
Summary Statement of Deficiencies D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a review of laboratory Proficiency Testing (PT) records and an interview with Laboratory Director (LD), the laboratory received an unsatisfactory performance score of 50% for Urine Colony Count in the American Proficiency Institute (API) 2019 Microbiology 3rd testing event. Findings: 1. A review of 2019 API PT records identified an unsatisfactory performance score of 50% for Urine Colony Count in the 2019 API Microbiology 3rd testing event. For sample UR-12 the laboratory reported "No growth", when the correct result was ">100,000 CFU/ml". This resulted in an unsatisfactory performance score of 50%. 2. An interview with the LD, on 11/6/19 at approximately 10:15 AM, confirmed the findings. 3. The laboratory took remedial action for the unsatisfactory performance and documented the action taken. 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 the Laboratory Director (LD), the laboratory received an unsatisfactory performance score of 0% for Vaginal Wet Preparation and an unsatisfactory performance score of 50% for Urine Sediment in American Proficiency Institute 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 -- (API) Hematology testing events of 2018 and 2019. Findings: 1. A review of 2018 API PT records identified an unsatisfactory performance score of 50% for Urine Sediment in the 2018 API Hematology 1st testing event. For sample US-01 the laboratory reported "RBC (Erythrocyte)", when the correct answer was "WBCs (Leukocytes)". This resulted in an unsatisfactory score of 50%. 2. A review of 2019 API PT records identified an unsatisfactory performance score of 0% for Vaginal Wet Preparation in the 2019 API Hematology 1st testing event. For sample VA-01 the laboratory reported "No yeast, Trich, or clue cells", when the correct answer was "Clue cells seen". This resulted in an unsatisfactory score of 0%. 3. An interview with LD, on 11/6/19 at approximately 10:15 AM, confirmed the findings. 4. The laboratory took remedial action for both unsatisfactory performances and documented the action taken. -- 2 of 2 --