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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

Is Your Document Control… Out of Control?

Donna M. Wolk, Ph.D., D(ABMM)

Southern Arizona VA Health Care System / Tucson


University of Arizona



  • Background, beginning 2001

  • Needs Assessment

  • Software Assessment & Implementation

  • Future Applications for Quality System Recommendations

Background laboratory medicine and pathology provides support for

BACKGROUND: Laboratory Medicine and Pathology provides support for:


VA Hospital plus Comprehensive Health Care Service to 8 Counties (Community-Based Outreach Clinics)


VA Research Service Line and

Biomedical Research Foundation of Southern Arizona

Our documents sept 2001
OUR DOCUMENTS, Sept., 2001 support for:

  • > 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: support for: 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

Internal assessment concerns
Internal Assessment Concerns support for:

  • 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
Main Trigger for Concerns: CAP Checklist Item, GEN 13806 support for:

  • 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
Benchmarking: support for:National Regulatory Compliance by Review of Inspection Deficiencies

  • Region 6, VA Regional Commissioner’s Office


Is your document control out of control

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

Is your document control out of control

Among top five CAP deficiencies, 1996. support for:

  • 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)

Is your document control out of control

Most Common CAP Deficiencies 1998-2001 support for:# 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

Is your document control out of control

JCAHO Deficiencies support for:Document 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)

Nccls now clsi
NCCLS, now CLSI support for:

  • 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
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
Regulations and Regulatory Agency Requirements Guidelines

  • 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
Summary: GuidelinesThe 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
Historical Document Control System Did Not Meet Our Needs Guidelines

  • 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 assessment

Software Assessment Guidelines

Help for controlling documents

Software resources review
Software Resources Review Guidelines

Examples of Software Solutions

MS Office Suite & Front Page Visio

Adobe Acrobat Proquis/All Clear

Integrum Documentum

SharePoint, Microsoft

Document control with proquis
Document Control with Proquis Guidelines

  • 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

Proquis DEMO!!!!! Guidelines

Is your document control out of control

Access on PC & Thin Client Guidelines Desktop

Is your document control out of control

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
PROQUIS User Interface Example: Documents Module Login’ window appears:

Uses the tabbed notebook style

  • Allows user to view details without having to open lots of windows

  • Allows related information to be displayed

Document control current status

Control Searches







History of changes

Superseded documents


Security of controlled documents


Retrieval of archived documents

Document Control, Current Status

Automated warnings
Automated warnings Searches

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
Software Facilitates Compliance to NCCLS Guidelines Searches

  • 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 Searches

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

Is your document control out of control
Software Links to QSEs SearchesAssessing and grouping each policy or procedure by the key elements of the Quality System Essentials

Expansion processes
Expansion Processes Searches

  • 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
Summary: Why must we control documents? To ensure . . . Searches

  • 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
Thank you Searches