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 surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to ensure that all TP who performed Hematology and Chemistry tests participated in the Academy of Family Physician (AAFP) PT events in the calendar years 2020 and 2021. The finding includes: 1. A review of all PT events revealed that only two out of seventeen TP performed PT for all events in 2020 and 2021. 2. The TP #3 listed on CMS form 209 confirmed on 12/7 /21 at 11:33 am that PT events were not rotated between TP. 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 surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to attain at least 80% or more for Hematology test performed on the Horiba ABX Micros 60 analyzer with the Academy of Family Physician (AAFP) in the 2021-A event. The finding includes: 1. The laboratory scored as follows in AAFP event 2021-A: a. 20% for Lymphocyte in percent, and Granulocyte Abs #. b. 40% for Lymphocyte Abs #. c. 60% Monocyte Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- /Mixed in percent. 2. The TP #3 listed on CMS form 209 confirmed on 12/7/21 at 11: 30 am the laboratory failed to achieve at least 80% for Hematology testing. D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to undertake appropriate training and employ technical assistance necessary to correct problems associated with PT failures performed on the Horiba ABX Micros 60 analyzer with the Academy of Family Physician (AAFP) in the 2021-A. The findings include: 1. There was no remedial action taken and documented for unacceptable Hematology results in event 2012-A with AAFP as follows: a. 20% for Lymphocyte in percent, and Granulocyte Abs #. b. 40% for Lymphocyte Abs #. c. 60% Monocyte/Mixed in percent. 2. The TP #3 listed on CMS form 209 confirmed on 12/7/21 at 11:30 am that