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 record review and an interview, the laboratory failed to rotate proficiency testing specimens among the personnel who routinely perform testing from 2016 through 2017. All patients tested at this laboratory have the potential to be affected. Findings include: 1. Review of proficiency testing documentation found that Testing Personnel #1 had participated in every proficiency testing event from 2016 through 2017. 2. An interview with the Performance Improvement Coordinator, on 3/12/18 at 9:32 am, confirmed that Testing Personnel #1 routinely performed proficiency testing activities from 2016 through 2017. 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 record review and interviews, the laboratory failed to retain quality control test records documenting analytic systems activities for at least two years. All patients tested at this laboratory have the potential to be affected. Findings include: 1. Review of quality control data, on 3/12/18 at 1:30 pm, found it was printed from the 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 -- instrument on thermal paper. 2. An interview with the Performance Improvement Coordinator and Testing Personnel #1 , on 3/12/18 at 1:30 pm, confirmed that neither electronic, nor hard copies were made from quality control instrument printouts, on thermal paper that fades over time, to ensure that they are retrievable and legible for at least two years. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review the laboratory failed to establish and follow written policies and procedures to assess and document the competency of the Technical Consultant based on the responsibilities of the position. All patients tested at this laboratory have the potential to be affected. Findings Include: 1. Review of the laboratory's competency documentation, on 3/12/18 at 10:40 am, found no completed competency assessment for the Technical Consultant based on responsibilities of that position. 2. Review of policies and procedures, on 3/12/18 at 10:40 am, found that the laboratory failed to establish a policy and procedure to determine Technical Consultant competency based on responsibilities of that position. 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)