Summary:
Summary Statement of Deficiencies D0000 The laboratory was surveyed on October 18, 2018. The facility was not in compliance with the following CLIA Conditions at 42 CFR part 493: D5400 - 42 C.F.R. 493.1250 Condition: Analytic Systems 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 review of the laboratory's submitted Form CMS-209, review of the laboratory's American Proficiency Institute's proficiency testing records from 2015 and 2016, and staff interview, it was revealed the laboratory failed to have documentation of rotating proficiency testing among all testing personnel. The findings were: 1. This is a repeat deficiency from the survey dated September 7, 2016. 2. A review of the laboratory's submitted Form CMS-209, signed by the laboratory director on October 16, 2018, revealed the laboratory identified 2 testing personnel. 3. A review of the laboratory's American Proficiency Institute's proficiency testing records from 2017 (events 1, 2, and 3) and 2018 (events 1 and 2) revealed testing personnel #1 as listed on Form CMS-209 performed proficiency testing for 5 of 5 testing events. 4. An interview with testing personnel one (as listed on Form CMS 209) on 10/18/2018 at 14:30 hours in the physician's office confirmed the findings. Key: CMS - Centers for Medicare and Medicaid Services D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic 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 -- systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on direct observations, review of laboratory policies, review of calibration records, review of maintenance records, and confirmed in interview of facility personnel, the laboratory failed to provide monitor and evaluate the overall quality of its analytic systems as evidenced by: 1. The laboratory failed to resolve flags on CBCs prior to their release to the healthcare provider (this is a repeat deficiency). (refer to D5405) 2. The laboratory failed to ensure centrifuge calibrations were performed at the designated times and failed to ensure the centrifuge was calibrated according the laboratory's policy (this is a repeat deficiency). (refer to D5435) 3. The laboratory failed to ensure calibrations on the Abbott Cell-Dyn 1800 hematology analyzer were performed according to manufacturer's instructions. (refer to D5437) D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, CELL DYN 1800 System Operator's Manual, random review of patient test records, and staff interview, it was revealed the laboratory failed to follow the manufacturer's instructions for assessing flags on hematology results. The findings were: 1. This is a repeat deficiency from the survey dated November 7, 2016. 2. Review of the laboratory's policies revealed a laboratory policy approved by the laboratory director on January 8, 2016 stated: "The director of the laboratory approves the use of the entire contents of the Cell-Dyn System Operator's Manual provided by Abbott Laboratories, as the procedure used for performing all hematology procedures." 3. A review of the CELL DYN 1800 System Operator's Manual (9140390A, March 2003) Section 10 "Troubleshooting and Diagnostics" within the table titled "DATA Problems" listed the following flags and required