Ghcscw Madison College Community Clinic

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 surveyor review of laboratory records and interview with the technical consultant, the laboratory did not retain documentation of the hematology differential stain quality control (QC) for two of two patients in 2022. Findings include: 1. Review of hematology records in the laboratory's SoftTotalQC program showed no documentation of quality control for hematology differentials stain in 2022. 2. Review of patients report print outs from the Sysmex XS1000 hematology analyzer showed no documentation of hematology differentials stain QC for two of two patients in 2022. 3. Interview with the technical consultant on April 13, 2023, at 2:17 PM confirmed the laboratory did not retain documentation of hematology differential stain QC in 2022. 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 --

Summary Statement of Deficiencies D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on surveyor review of personnel records and interview with the Technical Consultant, the Technical Consultant could not provide semiannual competence evaluation documentation for one of one new testing personnel for testing on the Sysmex hematology analyzer during the first year the individual tested patient specimens. Findings include: 1. Review of personnel records showed one new testing person (Staff A) had been testing patient specimens for more than one year. Records showed an initial competence evaluation for the Sysmex hematology analyzer in April 2019 and an annual competence evaluation in 2020. No additional competence records for Staff A for the Sysmex hematology analyzer in 2019 or 2020 were available. 2. Email correspondence from the Technical Consultant on June 28, 2021 at 4:08 PM confirmed documentation of the semiannual competence evaluation for staff A for testing on the Sysmex hematology analyzer could not be located. 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 --