Summary:
Summary Statement of Deficiencies D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Through review of the laboratory's policy and procedure for "General Supervisor Review of High Complexity Testing", review of Daily Slide Quality Control (QC) evaluation log for October through December of 2024, lack of documentation and interview it was determined that the laboratory failed to review data within 24 hours. Findings follow: A) Review of "General Supervisor Review of High Complexity Testing" laboratory policy revealed Section 1.0 "The purpose of the procedure is to describe the process by which high complexity testing (gross examination of biopsy specimens) will be reviewed within 24 hours. Electronic gross logs will be reviewed at the end of each day and noted daily on the Master QC log by the Medical Directory." B) Review of Daily Slide QC Evaluation October through December of 2024, seven days out thirty-nine days failed to review data within 24 hours. C) In an interview on 12/19/2024 at 1:35pm the laboratory manager confirmed seven days out thirty-nine days failed to review data within 24 hours from October through December of 2024. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --