Wellmed At East Forest

Summary Statement of Deficiencies D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of proficiency testing records for 2018 , 2019 and 2020, and interview of facility personnel, the laboratory failed to participate in 1 of 8 proficiency testing events for the specialty of hematology. The findings include: 1. A review of the American Proficiency Institute (API) proficiency testing records found the laboratory failed to submit the results for the 2020 Hematology 2nd testing event. a. Review of the 2020 Hematology 2nd event Performance Summary found no scores for the analytes Erythrocytes, Hematocrit, Hemoglobin, Leukocyte Count, MCH, MCHC, MCV, Platelet count,, for the hematology analyzer QBC 2. Interview of the Testing person 1 and 2 from the form 209 conducted on 9/23/2020 at 14;00 hrs confirmed that the laboratory failed to test specimens and submit results . 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 --

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's Individualized Quality Control Plan (IQCP) procedure and interview with facility personnel, the laboratory failed to identify the history in the laboratory's Risk Assessment (RA) for the QBC hematology analyzer. The findings included: a. At the time of the survey June 26, 2018 the laboratory failed to produce documentation for the history of Quality Control assessment of the Quality Control b. In an interview at 11:00 hours on 06/26/2018 in the office, the Testing person #1 from the CMS from 209 stated that the laboratory performed the Q C once every 3 weeks part of the IQCP risk assessment. 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 --