Summary:
Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) record's attestation statements for 2018 and an interview with the contract consultant, the laboratory failed to ensure the laboratory director signed the attestation statements in the first, second, and third events for complete blood count (CBC) of 2018. Findings include: 1. There were no laboratory director's signatures on attestation statements for the first, second, and third PT events for CBC specimens from 2018 available to review. 2. In an interview, November 7, 2018, at 2:30pm, the contract consultant confirmed the missing laboratory director signatures on the attestation statements for first, second, and third PT events for CBC specimens from 2018 available to review. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 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 daily Hematology quality control records and interview with the contract consultant determined that the laboratory failed to retain daily Hematology quality control records for the Coulter AcTdiff complete blood count (CBC) analyzer for November 7 until December 31, 2016. The findings include: 1. Lack of review of daily Hematology quality control records determined that the laboratory failed to retain daily Hematology quality control records for the Coulter AcTdiff CBC analyzer for November 7 until December 31, 2016. 2. Interview with the contract consultant on November 7, 2018 at 1:00pm confirmed that the laboratory failed to retain daily Hematology quality control records for the Coulter AcTdiff CBC analyzer for November 7 until December 31, 2016. 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 a review of the laboratory's procedure manual revealed no panic or alert values for the complete blood count (CBC) for 2016-2018 (Refer to D5403) and review of hematology calibration verification records for 2016 and 2018, a review of the manufacturer's instructions, the laboratory failed to perform hematology calibration verifications when due every six months in 2017 (Refer to D5439). 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)