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: Through review of Lab Quality Assessment: Quarterly Review reports dated January - March 2023, laboratory daily log sheet, quality control reports, lack of documentation and interview it was determined that the laboratory failed to retain quality control records or background check records for the Pochi Hematology analyzer. Findings follow: A) Review of the Quality Assurance Notes for 2023 revealed the following comments: 1) On the quarterly January - March report "excessive backgrounds on Pochi". 2) On the quarterly April - June report "Pochi out for one month" B) Review of the daily log dated October 23, 2023 revealed "sending Pochi out due to QC issues with various levels". C) Review of daily background counts for March, July and November 2023 revealed no instance when background counts were unacceptable. D) Review of QC results for March, July and November 2023 revealed no instance of quality control results failing to meet criteria for acceptability however no QC results were presented for November 1, 2023 through November 15, 2023. E) In an interview on 12/12/23 at 11:35 a.m., the laboratory staff member (#2 on the CMS 209 form) was asked if records of all QC result reports, including those which were unacceptable, and records of unacceptable background reports on the Pochi analyzer were retained. She stated that print-outs of unacceptable QC and background counts were discarded and were only kept for two weeks in the data files of the Pochi analyzer after that period there was no record. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 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 -- 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: Through review of the CMS 209 form, lack of documentation and interviews with laboratory staff, it was determined the laboratory failed to assess employee competency as directed in personnel requirements. Survey findings follow: A) Review of the CMS 209 form submitted by the laboratory revealed that the laboratory staff member (#2 on the CMS 209 form) was listed as the technical consultant. B) Review of personnel records for laboratory staff member (# 2 on the CMS 209 form) revealed that no competency evaluation for the position of technical consultant was present for calendar year 2023. B) Upon request, the laboratory was unable to provide documentation of competency determinations for calendar year 2023 for the position of technical consultant for the personnel identified above. C) In an interview at 1:31 p. m. on December 12, 2023 the health system staff member (# 2 on the Entrance/Exit Conference Attendance Record) confirmed that competency determinations have not been performed on the personnel designated as technical consultant and that she had served as technical consultant for the full year of 2023. D5783