Summary:
Summary Statement of Deficiencies 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 2018, 2019, 2020, and 2021 QC(quality control) records and the absence of documentation 3/16/21, the laboratory failed to retain all required QC records for the Triage Meter Cardiac Panel and D-Dimer testing performed. Findings: Review of the Triage Meter Cardiac Panel and D-Dimer QC records 3/16/21 revealed the laboratory failed to retain copies of the Triage Total 5 control assay sheets with the quality control material acceptable ranges for the following lot numbers: 1. Level 1 lot # C3450, expiration date 6/13/19; 2. Level 1 lot # C3498, expiration date 9/14 /19; 3. Level 1 lot # C3452, expiration date 11/17/19; 4. Level 1 lot # C3454, expiration date 1/7/20; 5. Level 1 lot # C3532, expiration date 1/27/20; 6. Level 1 lot # C3534, expiration date 2/10/20; 7. Level 1 lot # C3535, expiration date 2/24/20; 8. Level 1 lot # C3536, expiration date 3/13/20; 9. Level 1 lot # C3537, expiration date 3 /22/20; 10. Level 2 lot # C3492, expiration date 7/25/19; 11. Level 2 lot # C3494, expiration date 9/5/19; 12. Level 2 lot # C3460, expiration date 11/15/19; 13. Level 2 lot # C3463, expiration date 1/5/20; 14. Level 2 lot # C3555, expiration date 1/19/20; 15. Level 2 lot # C3558, expiration date 2/9/20; 16. Level 2 lot # C3559, expiration date 2/22/20; 17. Level 2 lot # C3562, expiration date 3/30/20. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require