Is Your Document Control… Out of Control?
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Transcript of 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 Future Applications for Quality
System Recommendations
BACKGROUND: Laboratory Medicine and Pathology provides support for:
CLINICAL SERVICESVA Hospital plus Comprehensive Health Care Service to 8 Counties (Community-Based Outreach Clinics)
RESEARCHVA Research Service Line andBiomedical Research Foundation of Southern Arizona
Clinical Laboratory & Research Core
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
Types of Documents Found
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
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)
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)
Benchmarking: National Regulatory Compliance by Review of Inspection Deficiencies
Region 6, VA Regional Commissioner’s Office
CAP, JCAHO, VA
Benchmark 2001: We are not alone….. NATIONALLY:Most Frequent CAP Deficiencies in Clinical Laboratory Inspections Continually Relate to Document Control Issues
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)
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 by Albert Rabinovitch, MD, PhD, CAP in 1998 and Reported again byReported again by Francis Sharkey, MD, CAP in 2001Francis Sharkey, MD, CAP in 2001
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)
Search for Information, Helpful Resources
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
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
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
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
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
Software AssessmentHelp for controlling documents
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
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
Proquis DEMO!!!!!
Access on PC & Thin Client Desktop
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
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
The Document Viewer: Section, Title Author or Keyword Searches
Document Control, Current Status
Control Access Distribution Changes Authorizations Confirmations
Maintains History of changes Superseded
documents
Improves Security of
controlled documents
Communication Retrieval of
archived documents
Automated warningsDocument review date
Unauthorized change request
Change notification unconfirmed
Documents can be linked or cross-referencedFacilitates 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
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
Other Software Modules at SAVAHCS
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
Software Links to QSEsAssessing and grouping each policy or procedure by the key elements of the Quality System Essentials
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
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.
Thank you