Transcript General

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
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Background, beginning 2001
Needs Assessment
Software Assessment &
Implementation
Future Applications for Quality
System Recommendations
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
Clinical Laboratory & Research Core
OUR DOCUMENTS,
Sept., 2001
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> 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
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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
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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
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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
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Does the laboratory quality improvement
program follow a documented
operational plan? NOTE: Plan may be
based on:
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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
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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.
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Is a complete procedure manual written
substantially in compliance with NCCLS GP2A2 available at the workbench or in the work
area?
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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 again by Francis Sharkey, MD, CAP in 2001
JCAHO Deficiencies
Document control in top 10 of all
deficiencies, nationally
IM.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
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GP26A: A Quality System Model
for Health Care, Approved
Guidelines (October 1999)
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Part 4.6, Quality System
Essentials, Documents and
Records
GP2-A4 Clinical Laboratory
Technical Procedure Manuals; 4th
Edition
International Organization for
Standardization (ISO) Guidelines
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ISO 9001 (Third edition 12-15-2000)
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Section 4. Quality Management System
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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
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College of American Pathologist Standards
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Joint Commission on Accreditation of Healthcare
Organizations Standards
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U.S. Federal Laws, Code of Federal Regulations, Federal
Register, CLIA, FDA, GLP, etc.
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Veterans Health Administration Directive and Handbook
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American Association of Blood Banks Standards
Summary:
The Document Control Needs are:
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Documents (policies, processes
and procedures) must be
identified, reviewed, approved, and
retained
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Records must be created, stored
and archived
Historical Document Control System Did Not Meet
Our Needs
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Paper copies in duplicate locations
Retired copies in manager’s file cabinets
Electronic documents saved in various
locations
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C drives
Common S drive on network server
Floppy disks
Not at all
Reviews performed yearly typically en
masse
Software Assessment
Help 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
Adobe Acrobat
Integrum
SharePoint, Microsoft
Visio
Proquis/All Clear
Documentum
Document Control with Proquis
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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
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Allows related
information to be
displayed
The Document Viewer: Section, Title
Author or Keyword Searches
Document Control, Current Status
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Control
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Access
Distribution
Changes
Authorizations
Confirmations
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Maintains
 History of
changes
 Superseded
documents
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Improves
 Security of
controlled
documents
 Communication
 Retrieval of
archived
documents
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
Software Facilitates Compliance
to NCCLS Guidelines
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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
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Customer
Care
Document
Control 
FMEA/Design
Control
Vendor Control
Equipment
Control 
Customized
Reports 
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Testing House
Fault Log 
Audit &
Management
Review
Health & Safety
Personnel and
Training 
Flow Charting 
Software Links to QSEs
Assessing and grouping each policy or
procedure by the key elements of the
Quality System Essentials
Expansion Processes
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Fault Logs
Equipment Maintenance Logs (limited)
Personnel Training Records
Assessments in Progress
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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 . . .
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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