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Womack Army Medical Center, Fort Bragg, NC. “Committed to Those We Serve”. Quality System Essentials. Quality Control – provides feedback to operational staff about the state of the process that is in progress. Acceptable – continue with process
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Womack Army Medical Center, Fort Bragg, NC “Committed to Those We Serve”
Quality System Essentials • Quality Control – provides feedback to operational staff about the state of the process that is in progress. • Acceptable – continue with process • Unacceptable – stop until a problem is resolved • Quality Assurance – activities that are not tied to the actual performance of the process. • Retrospective review and evaluation of operational performance • Quality Management – interrelated processes in the context of the organization • Leadership role in commitment to quality • Encompasses the quality systems approach
Quality System Essentials • Documents and Records • Organization • Personnel • Equipment • Purchasing and Inventory • Process Control • Information Management • Occurrence Management • Internal and External Assessment • Process Improvement • Customer Service • Facilities and Safety
Quality System Essentials • Quality Management as an Evolving Science • The principles and tools in use today will change as research provides new knowledge of organizational behavior, as technology provides new solutions, and as the field of laboratory medicine presents new challenges • AABB Technical Manual – 15th ed
Quality System Essentials QSE ToolsMonthly QA Checklists • Submitted monthly by section supervisors • Summary of their QA activities • QC/QC reviews • Preventive Maintenance • Timed activities • Weekly, monthly, quarterly, semi-annual, annual • Corrective actions taken • Reviewed by Quality Manager • Reviewed by section’s Medical Director • Which QSE does this address??
Quality System Essentials Document Control • Document Control Standard Operating Procedure (SOP) • Standard format for SOPs and Forms • Matches up with items on the control logs • Only the current version in use • Document Control Logs • Location, version, reviews • Forms Control Logs • What QSE does this represent?
QUALITY ASSURANCE CHECKLIST Body of Form HEM FORM 39 December 12, 2007
Quality System Essentials Forms Control Log
Quality System Essentials Audit Tool • Audit schedule – annual • Cross reference monthly QA Checklist to make sure original documents reflect the items listed on the QA Checklist • Spot check document control accuracy • Annual/Semi annual Competency audit • Quality Control records and corrective action documentation • Phlebotomy Area – Patient identifiers, safety, HIPAA • Unannounced audits – based on observation • Which QSE does this address?
Quality System Essentials Occurrence Management • DA4106 (Incident report) • Log item and resolution • Interdepartmental • Lab generated • Generated Outside Dept of Pathology • Quality Management report • Internal to Department of Pathology • Errors caught prior to release of results • What QSE does this represent?
Quality System Essentials Proficiency Testing • Is your testing process in control? • Measuring system • Technical competence • Clerical • Investigation of failed proficiency testing • Use a comprehensive form • Determine root cause • Prove you can obtain the correct result • What QSE does this address?
Quality System Essentials Personnel • Gains and Losses • New Employee Orientation • Learning methods • AV- Audiovisual • V- Verbal • R-Review of Documents • I-In service • Training • Competency assessment • 6 month • Annual
Quality System Essentials QI Monitor ESTABLISHED THRESHOLD <3% Which QSE is addressed?
Quality System Essentials Integration into QI Program/Minutes • QI Worksheet • Broken down by QSE • Submitted monthly • By section supervisors • One week prior to QI meeting • Collated by Quality Manager • Presented at QI meeting • Submitted as the QSE attachment to the minutes
Quality System Essentials The Final Product • QSE attachment to Department of Pathology monthly QI minutes • All 12 QSEs addressed during QI meeting • Opportunity for discussions • Add/correct items • Laboratory Director and Laboratory manager as well as staff are aware of all quality activities at that snapshot in time