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