Summary:
Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on two year (2017 and 2018) CAP proficiency testing record review and interview with testing person #1, the laboratory failed to rotate proficiency testing (PT) events to include all testing personnel who routinely performed patient testing for - 6 out of 6 testing events for chemistry and hematology. - 4 out of 4 testing events for urinalysis-microscopy. The findings include: CAP proficiency testing record review on 11/30/18 2:00pm for two-years 2017 and 2018 for A- Chemistry tests Direct bilirubin, total bilirubin, calcium, chloride, CO2 (carbon dioxide), creatinine, glucose, potassium, sodium, urea nitrogen, ALT (alanine aminotransferase), albumin, alkaline phosphatase, AST (aspartate aminotransferase), magnesium, phosphorus, total protein B- Hematology tests Cell identification/ flow differential Erythrocyte count (red blood cells) Hematocrit Hemoglobin Leucocyte count (white blood cells) Platelet count PTT (partial thromboplastin time) Prothrombin time C- Microscopy- urinalysis Showed that testing person #2 (1 out of 3 testing personnel) had participated for (I)- 6 out of 6 CAP proficiency-testing events for chemistry and Hematology tests for year 2017 and 2018. (II)- 4 out of 4 testing events for microscopy- urinalysis for year 2017 and 2018. During an interview on November 30, 2018, at 3:00pm, the testing person #1 confirmed that the laboratory did not rotate proficiency testing (PT) events to include testing personnel #1 and #3 for any testing events for year 2017 and 2018, who routinely performed (A, B and C) chemistry , hematology, and microscopy- urinalysis tests. 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 --