Summary:
Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on procedure manual and quality assurance (QA) record review and interview with the clinical coordinator, the laboratory did not follow written procedures for performing chart reviews to ensure that patient results from testing on the Affirm VPIII were documented and entered accurately. Findings: 1. The procedure "Quality Assurance - Affirm Testing" states, "The Clinical Coordinator (Testing Supervisor) will insure that the Affirm Test result log is reviewed for accuracy and proper charting each month." "In general, 5-7 log entries will be reviewed for entry completion, results documented in the EHR, order (by provider) documented in EHR, and the scanned copy of results is present." It also states, "Reviewed entries will be listed on a form and the clinical coordinator will insure any necessary action (procedure reminders, entering missing results, error investigation, etc.) is taken and documented as such." 2. A review of QA logs from July, 2018 to December, 2020 showed that 1 of 26 months, 2 patients were checked; 4 of 26 months, 3 patients were checked; and 10 of 26 months, 4 patients were checked. 3. In September, 2018 1 of 5 patients checked had "No" marked for "Results in OM?" but no