Summary:
Summary Statement of Deficiencies D0000 The laboratory was surveyed on September 19, 2018 and found to be out of compliance with the CLIA regulations at: D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems; Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of laboratory policy, review of the laboratory's American Proficiency Institute (API) proficiency test records, review of patient test results, and confirmed in interview of facility personnel, the laboratory failed to test PT (proficiency testing) samples the same number of times it tests patient samples. The findings were: 1. Review of the laboratory's policy titled, "Proficiency Testing" approved by the laboratory director on January 1, 2004 stated, "PT specimens are to be treated the same as patient samples ..." 2. Review of the laboratory's policy titled, "Policy for Repeating CBC Tests" approved by the laboratory director on November 18, 2011, stated, "In an effort to ensure accuracy in patient CBC testing, it is the policy of this laboratory to repeat tests when patient results are outside the following ranges: RBC less than 3.5 or greater than 7.00 million WBC less than 3.5 or greater than 20.00 thousand HCT less than 30% or greater than 46% HGB less than 10 or greater than 18MG% PLT less than 100 or greater than 450 thousand 3. Review of API proficiency testing records from 2016 (event 3), 2017 (events 1, 2, and 3), and 2018 (event 1) revealed the following PT samples did not meet the laboratory's repeat criteria but were repeated: 2016 (event 3) ID: HEM-15 Tested: 11-17-16 @ 10:42 11- Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 17-16 @ 10:48 2017 (event 3) ID: HEM-12 Tested: 11-17-17 @ 12:35 11-17-17 @ 12:38 2018 (event 1) ID: HEM-02 Tested: 03-15-18 @ 10:31 03-15-18 @ 10:32 4. The findings were confirmed in interview with the technical consultant on 09/19/2018 at 0930 hours in the office. Key: CBC - complete blood count D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic 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 review of the laboratory's policies, manufacturer's instructions, surveyor observation, review of patient test records, and staff interview, it was revealed the laboratory failed to have documentation of a policy that ensured the verification of CBC (complete blood counts) results with flags. (refer to D5403) D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)