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 profciency testing (PT) attestation records from American Academy of Family Physicans (AAFP), the CMS-209 testing personnel form and interview with the Technical Consultant on March 10, 2020, the laboratory failed to test proficiency samples by all personnel with the laboratory's regular patient workload. The findings icluded: a. On the CMS-209 laboratory personnel form, the laboratory has listed three individual testing personnel, one (1) Medical Technologist (MT) and two (2) medical assistants. b. According to the AAFP attestation forms for the years 2018 and 2019, each AAFP testing event for waived and non-waived testing,was performed by all three testing personnel on consecutive days prior to the submission cut off dates by the PT organization. c. Review of the AAFP testing event records show that all of the testing for waived and non-waived testing results submitted by the laboratory, indicated that only the one (1) MT testing results, were submitted to the AAFP PT testing organization for the years 2018 and 2019, for all PT tests performed. d. The laboratory technical consultantant affirmed by interview that all three testing personnel performed all the PT testing (waived and nonwaived) and only the (MT) results were submitted for evaluation to the PT organization. e. The laboratory reports performing approximately 2803 nonwaived hematology specimens annually, and approximately 1997 waived tests annually. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the laboratories Quality control quarterly Peer review records from Beckman Coulter for the AC*T DIFF2 Hematology analyzer, and interview with the laboratory technical consultant and testing personnel on March 10, 2020, the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. The findings included: a. The laboratory is enrolled in the Beckman Coulter quarterly interlaboratory Quality Assurance (QA) Program for the AC*T DIFF2 Hematology analyzer. 1. During the years 2017, 2018 and 2019 the analyzer data was not submitted for assessment due to loss of the quality control disc from the analyzer. The laboratory had no documentation of