Summary:
Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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 record review of API (American Proficiency Institute) Chemistry proficiency testing and interview with the Laboratory Supervisor, the laboratory failed to score at least 80% for the 2nd event of 2018. Findings Included: Review of API proficiency testing showed a score of 60% in the 2nd testing event of 2018 for the following analytes: Albumin, Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Direct Bilirubin, Total Bilirubin, Total Calcium, Chloride, Total High-density Lipoprotein Cholesterol, Total Cholesterol, Carbon Dioxide, Creatinine, Glucose, Low-density Lipoprotein Cholesterol, Phosphorus, Potassium, Sodium, Total Protein, Triglycerides, and Blood Urea Nitrogen. During an interview on 5/28/19 at 12:03pm the Laboratory Supervisor confirmed the failed proficiency testing scores. D2099 ENDOCRINOLOGY CFR(s): 493.843(b) 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 record review of API (American Proficiency Institute) Endocrinology proficiency testing and interview with the Laboratory Supervisor, the laboratory failed to score at least 80% for the 2nd event of 2018. Findings Included: Review of API 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 -- proficiency testing showed a score of 60% in the 2nd testing event of 2018 for the following analyte: Thyroid Stimulating Hormone. During an interview on 5/28/19 at 12:03pm the Laboratory Supervisor confirmed the failed proficiency testing score. 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 record review of API (American Proficiency Institute) Hematology proficiency testing and interview with the Laboratory Supervisor, the laboratory failed to score at least 80% for the 1st event of 2019. Findings Included: Review of API proficiency testing showed a score of 60% in the 1st testing event of 2019 for the following test: Blood Cell Identification. During an interview on 5/28/19 at 12:03pm the Laboratory Supervisor confirmed the failed proficiency testing score. -- 2 of 2 --