Summary:
Summary Statement of Deficiencies D2127 HEMATOLOGY CFR(s): 493.851(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 reviews of 2017: 2nd event proficiency testing reports from CMS (report 155D, Individual laboratory profile) and API (American Proficiency Institute), laboratory proficiency testing records, and patients test reports; and interview with the Technical Consultant, the laboratory failed to return proficiency testing results within the time frame specified by API; and thus, attained a score of 0%, consituting unsatisfactory hematology performance. Findings include: a. CMS and API reported no scores for 2017: event 2 for all hematology testing: RBC (Red Blood Cell count) HGB (Hemoglobin) HCT (Hematocrit) Platelets WBC (White Blood Cell count) WBC Differential b. Laboratory proficiency testing records revealed 5 out of 5 samples were tested on 7/12/17; however, the laboratory failed to report the results to API. c. The Technical Consultant affirmed (3/20/18) the aforementioned failure to report results to API by their specified deadline. d. The reliability and quality of results reported could not be assured. Based on the stated estimated annual test volume, the laboratory reported approximately 3,325 hematology results each month during the timeframe July to October 2017. A few examples are as follows: Date (number of patients tested) ...one ID ---------------------------------------------------------- 7 /11/17 (39) ............................ S, J 8/18/17 (17) ............................ K, P 9/13/17 (34) ............................ D, J 10/26/17 (28) .............................T, H 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 --