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Is Your Document Control… Out of Control?

Is Your Document Control… Out of Control?. Donna M. Wolk, Ph.D., D(ABMM) Southern Arizona VA Health Care System / Tucson & University of Arizona 4/6/2006. Overview. Background, beginning 2001 Needs Assessment Software Assessment & Implementation

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Is Your Document Control… Out of Control?

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  1. Is Your Document Control… Out of Control? Donna M. Wolk, Ph.D., D(ABMM) Southern Arizona VA Health Care System / Tucson & University of Arizona 4/6/2006

  2. Overview • Background, beginning 2001 • Needs Assessment • Software Assessment & Implementation • Future Applications for Quality System Recommendations

  3. BACKGROUND: Laboratory Medicine and Pathology provides support for: CLINICAL SERVICES VA Hospital plus Comprehensive Health Care Service to 8 Counties (Community-Based Outreach Clinics) RESEARCH VA Research Service Line and Biomedical Research Foundation of Southern Arizona

  4. Clinical Laboratory & Research Core

  5. OUR DOCUMENTS, Sept., 2001 • > 800 documents in 35 manuals • Hundreds of gov’t policies & memos, paper and web-based • 6 research protocols • Educational modules • Records

  6. Personnel: Training, competency, qualifications, job/position descriptions Organization: Organizational charts, definitions, responsibilities & relationships, inspection and accreditation records, Provision of Service Plan, Quality Plan Safety: Accidents reports, Chemical Hygiene Plan, Biohazardous Waste Disposal Plan, Shipping and Handling of Biologicals, Infection Control Plan Audits: Internal and external Performance: Quality assurance records, performance improvement records, faults, reporting errors and accidents, root cause analysis records and corrective action plans Supplies and Equipment: Identification, inventory list, validation records, operation/maintenance checks, and quality control records Manuals: Policies, processes and standard operating procedures Research Protocols Misc. Records Types of Documents Found

  7. Internal Assessment Concerns • Development of the new Molecular Lab Program and Clinical Research Core • Rapid changes in the lab and increased training requirements • Future compliance to quality systems regulations, especially document control • Research issues (GLP)

  8. Main Trigger for Concerns: CAP Checklist Item, GEN 13806 • Does the laboratory quality improvement program follow a documented operational plan? NOTE: Plan may be based on: • NCCLS GP-26 • ISO • JCAHO • AABB • Lab’s own design • Quality Plan Info. has strong emphasis on document control, our # 1 CAP deficiency (1996-2001)

  9. Benchmarking: National Regulatory Compliance by Review of Inspection Deficiencies • Region 6, VA Regional Commissioner’s Office • CAP, JCAHO, VA

  10. Benchmark 2001: We are not alone….. NATIONALLY:Most Frequent CAP Deficiencies in Clinical Laboratory Inspections Continually Relate to Document Control Issues

  11. Among top five CAP deficiencies, 1996. • Is a complete procedure manual written substantially in compliance with NCCLS GP2-A2 available at the workbench or in the work area? • Is there documentation of at least annual review of all procedures in the <section> laboratory by the current laboratory director or designee? (Information from CAP Advanced Inspectors Training 1996)

  12. Most Common CAP Deficiencies 1998-2001# 1:Procedure Manuals: Annual review and date/sign each procedure.# 2:Procedure Manual Format: in NCCLS format; personalize manufacturer’s manuals/inserts. Reported by Albert Rabinovitch, MD, PhD, CAP in 1998 and Reported again byFrancis Sharkey, MD, CAP in 2001

  13. JCAHO DeficienciesDocument control in top 10 of all deficiencies, nationallyIM.7.10 The laboratory has current descriptions and instructions for all analytical methods and procedures.For entire VA (Also among most common deficiency, mainly in CBOCs)(Most frequently cited standards in laboratory inspections of Jan-Dec.1997, as published by JCAHO)

  14. Search for Information, Helpful Resources

  15. NCCLS, now CLSI • GP26A: A Quality System Model for Health Care, Approved Guidelines (October 1999) • Part 4.6, Quality System Essentials, Documents and Records • GP2-A4 Clinical Laboratory Technical Procedure Manuals; 4th Edition

  16. International Organization for Standardization (ISO) Guidelines • ISO 9001 (Third edition 12-15-2000) • Section 4. Quality Management System • 4.2 Document requirements • 4.2.1 General; documented procedures to control all documents and data • 4.2.2 Quality manual • 4.2.3 Control of documents • 4.2.4 Control of records

  17. Regulations and Regulatory Agency Requirements • College of American Pathologist Standards • Joint Commission on Accreditation of Healthcare Organizations Standards • U.S. Federal Laws, Code of Federal Regulations, Federal Register, CLIA, FDA, GLP, etc. • Veterans Health Administration Directive and Handbook • American Association of Blood Banks Standards

  18. Summary:The Document Control Needs are: • Documents (policies, processes and procedures) must be identified, reviewed, approved, and retained • Records must be created, stored and archived

  19. Historical Document Control System Did Not Meet Our Needs • Paper copies in duplicate locations • Retired copies in manager’s file cabinets • Electronic documents saved in various locations • C drives • Common S drive on network server • Floppy disks • Not at all • Reviews performed yearly typically en masse

  20. Software Assessment Help for controlling documents

  21. Software Resources Review www.qualitydigest.com/feb01/html/docbg.html www.documantmanagement.org.uk/pages/vendors.htm www.pdmic.com/vendors/docimage1.html Examples of Software Solutions MS Office Suite & Front Page Visio Adobe Acrobat Proquis/All Clear Integrum Documentum SharePoint, Microsoft

  22. Document Control with Proquis • Keeps all the details of the documents, including the documents (.doc, .xls., .pdf, etc) themselves. • Maintains the controls and security levels (authorship, authorization, etc.) to be applied to each document. • Details distribution and access of each document • Records change requests • Records approvals and confirmations of changes • Archives documents and keeps history

  23. Proquis DEMO!!!!!

  24. Access on PC & Thin Client Desktop

  25. When you open PROQUIS, the complete application, the ‘User Login’ window appears: User number decided locally: e.g., IEN, commonly known as the VISTA “tech code”) Security is maintained by using passwords that are chosen by each individuals

  26. PROQUIS User Interface Example: Documents Module Uses the tabbed notebook style • Allows user to view details without having to open lots of windows • Allows related information to be displayed

  27. The Document Viewer: Section, Title Author or Keyword Searches

  28. Control Access Distribution Changes Authorizations Confirmations Maintains History of changes Superseded documents Improves Security of controlled documents Communication Retrieval of archived documents Document Control, Current Status

  29. Automated warnings Document review date Unauthorized change request Change notification unconfirmed Documents can be linked or cross-referenced Facilitates ease of access to related documents Microsoft Access Based Integrated database system: changes in one section trigger any required updates of other areas of the system automatically

  30. Software Facilitates Compliance to NCCLS Guidelines • Standardized formats for all documents • Document identification including version • Change Control for documents • Distribution Lists • Master file of all documents with current and historical versions • Master index of documents • Documentation of approval and review • Use of only current documents • Identification, archiving and retreival

  31. Customer Care Document Control  FMEA/Design Control Vendor Control Equipment Control  Customized Reports  Testing House Fault Log  Audit & Management Review Health & Safety Personnel and Training  Flow Charting  Other Software Modules at SAVAHCS

  32. Software Links to QSEsAssessing and grouping each policy or procedure by the key elements of the Quality System Essentials

  33. Expansion Processes • Fault Logs • Equipment Maintenance Logs (limited) • Personnel Training Records Assessments in Progress • Staff’s Feedback after Training and Hands-on • Supervisor and Manager’s Review as SOP Review Dates are Automatically Generated • Expectation/Preparation for CAP Inspection • Web-links in process • Encryption for signatures/GLP in process • Outlook e-mail is easist, not compatible with VISTA

  34. Summary: Why must we control documents? To ensure . . . • regulatory requirements are satisfied. • provision of adequate personnel to perform, verify, and manage all activities. • performance of calibration, maintenance, and monitoring of equipment. • provision of consistent high quality critical materials and services from contracted suppliers. • provision of safe and adequate environmental conditions in the work place. • control of processes.

  35. Thank you

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