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 review of testing personnel (TP) records, review of review of 2018 and 2019 American Proficiency Institute (API) hematology proficiency testing (PT) records and interview with testing personnel (TP) 8/28/19, the laboratory failed to ensure all testing personnel who routinely perform patient testing participated in the hematology proficiency testing events. Review of laboratory TP records revealed the laboratory employs 2 TP. TP #1 began employment prior to 2017 and TP #2 began employment in April of 2018. Review of 2018 and 2019 API PT records revealed that TP #2 did not sign attestation statements for any of the API PT testing events. All attestation statements were signed by TP #1. Interview with TP #1 at approximately 12:00 p.m. confirmed TP #2 did not participate in any API PT testing events for 2018 and 2019. She stated she was planning to have her participate in the next upcoming PT event. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of laboratory quality control records, review of laboratory calibration Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- records and interview with testing personnel (TP) 8/28/19, the laboratory failed to retain manufacturer's quality control and calibration assay sheets for the Medonic M- series hematology analyzer for at least 2 years. Review of laboratory quality control records revealed no quality control assay sheets were retained for the hematology testing performed. Review of laboratory calibration records revealed only the calibration assay sheet from the 8/10/17 initial set-up of the hematology analyzer was retained. Interview with TP#1 at approximately 11:00 a.m. confirmed the laboratory had not retained the manufacturer's quality control assay sheets and had only retained the manufacturer's calibration assay sheet from the initial calibration of the hematology analyzer. 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)