Summary:
Summary Statement of Deficiencies 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 the surveyor's review of the laboratory's records for evaluation of proficiency testing performance from the CMS 96 Report, laboratory proficiency reporting from API (American Proficiency Institute), and an interview with the LP (laboratory personnel) on 12/16/2021 between 3:30 p.m. and 4:30 p.m., it was determined that there were two unacceptable (below 80 %) proficiency testing (PT) results for Hematology in cycle 2, 2021. Findings include: 1. On 12/16/2021, an inspection was conducted between 3:30 p.m. and 4:30 p.m. 2. During a review of the laboratory documentation from API , it was noted at approximately 4:00 p.m. that there were two unacceptable PT results for Hematology. The laboratory utilizes the Abbott Cell-Dyn instrument for Hematology testing. The LP recognized these atypical results. 3. The findings and acceptable ranges were as follows: Cycle 2 Hematology Analyte: MCH (2/5 unacceptable) Sample Actual Result Expected Result (range) HEM-09 29.1 22.0-25.8 HEM-10 34.4 27.1-30.7 Analyte: MCV (2/5 unacceptable) Sample Actual Result Expected Result (range) HEM-09 99.8 75.4-81.5 HEM-10 98.5 87.6-93.7 4. The LP affirmed the unacceptable results listed above. 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 --