electronic documentation for policies and procedures_final2.pdf
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Electronic Documentation for
Policies and Procedures
Document Management in the Modern Laboratory
Pathology Informatics 2011
J. Mark Tuthill, MD
Division Head, Pathology Informatics
Department of Pathology & Laboratory Medicine
Henry Ford Hospital
Detroit, MI
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J. Mark Tuthill, MD, Henry Ford Hospital
Goal and Objectives Define document management
Understand requirements for document management
Review process for selection of documentmanagement software
Describe requirements for selection
Discuss implementation process
ISO 15189 Show software
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What is Document Management? Somewhat confused term currently
Many vendors are focused on document scanning
software, not electronic policy and procedureworkflow management
Generic: a defined process for managing documentsrelated to business processes
What I will discuss is software for computer basedmanagement of laboratory policies and procedures
Our labs have a huge number of such documents!
How about Yours?
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Why do you Need Document
Management? The process of managing documents is daunting and
time consuming
Clinical laboratories have thousands of policies andprocedures
Electronic systems provide efficient, effective, costsaving approach
CAP accreditation requires a document management
process/policy to handle laboratory policies andprocedures
Not yet an electronic requirement
A key component of ISO 15189 accreditation focuses onhighly controlled management of documents
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What is Document Management?
Paper Procedure and policy binders
Annual review of policy and procedures
Complicated process of circulating paper documents
Keeping them up to date
Documenting review and understanding by staff
Manual sign off of each policy and procedure
Access to paper binders across laboratories
Updates by inserting new document versions tobinders
A policy governing how this will all be managed
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What is Document Management?
Electronic Procedures and policies managed online in organizers
Annual review managed online
Electronic creation and sign-off
Updates by electronic versioning Simplified process for circulating documents and keeping them up
to date
Email notification
On line quizzes to documenting review and understanding by
staff Access to online documents for laboratory and non-laboratory
personnel
PDFs, Word Documents
Inherent electronic governance, dating and naming enforces
document management policies
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System Selection
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Selection Process
RFI and RFP Process
Formal RFI and RFP process
Used the Internet and personal references to identify10-15 systems that may be applicable
Formed lab working group to indentify requirements
Submitted RFI (Request for Information) to these vendors
Based on responses we identified 4 vendors that were
most feasible Submitted an RFP (Request for Proposal) based on system
selection criteria developed by the working group
Defined an evaluation form to rate the various proposal
Carefully reviewed offerings
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Selection Process Evaluated possible vendors who responded to the RFP
Demonstrations
Live and web based Product literature and specifications
Cost
Contract review
Ratings and outcomes were reviewed and vetted withthe workgroup, laboratory leadership team, andinformatics leadership
This took months!
Well worth the effort and wait based on the final
selection
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Selection Analysis Vendor list
Specification Analysis Excel
Assessment of Finalists
http://localhost/var/www/apps/conversion/tmp/scratch_8/List%20of%20Document%20Management%20Systems%20Identified.dochttp://localhost/var/www/apps/conversion/tmp/scratch_8/PALM_DMS_SPECS.xlshttp://localhost/var/www/apps/conversion/tmp/scratch_8/DMS_SPECS_ANALYSIS_v6_jmt.xlshttp://localhost/var/www/apps/conversion/tmp/scratch_8/DMS_SPECS_ANALYSIS_v6_jmt.xlshttp://localhost/var/www/apps/conversion/tmp/scratch_8/PALM_DMS_SPECS.xlshttp://localhost/var/www/apps/conversion/tmp/scratch_8/List%20of%20Document%20Management%20Systems%20Identified.dochttp://localhost/var/www/apps/conversion/tmp/scratch_8/List%20of%20Document%20Management%20Systems%20Identified.doc -
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Vendor list Policy Technologies
http://www.policytech.com
Policy Medical
http://www.policymedical.com/
Zequel, Dynamic Policy 4.0
http://www.zequel.com
Soft Tech Health
http://www.softtechhealth.com/DM_PolicyMgmtOverview.asp
EZ Content Manager
http://www.acom.com/document_management/index.html?utm_id=1008
J. Mark Tuthill, MD, Henry Ford Hospital
http://www.policytech.com/http://www.policymedical.com/http://www.zequel.com/http://www.softtechhealth.com/DM_PolicyMgmtOverview.asphttp://www.softtechhealth.com/DM_PolicyMgmtOverview.asphttp://www.acom.com/document_management/index.html?utm_id=1008http://www.acom.com/document_management/index.html?utm_id=1008http://www.acom.com/document_management/index.html?utm_id=1008http://www.acom.com/document_management/index.html?utm_id=1008http://www.softtechhealth.com/DM_PolicyMgmtOverview.asphttp://www.softtechhealth.com/DM_PolicyMgmtOverview.asphttp://www.zequel.com/http://www.policymedical.com/http://www.policytech.com/ -
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Vendor list Knowledge tree
http://www.knowledgetree.com
Master Control Documents
http://www.mastercontrol.com/solutions/document_control_fb.html
Chem SW
http://www.chemsw.com/12197.htm
Innovative Data Solutions (IDS): PowerDMS http://www.imagineids.com/products/powerDMS.aspx
J. Mark Tuthill, MD, Henry Ford Hospital
http://www.knowledgetree.com/http://www.mastercontrol.com/solutions/document_control_fb.htmlhttp://www.mastercontrol.com/solutions/document_control_fb.htmlhttp://www.chemsw.com/12197.htmhttp://www.imagineids.com/products/powerDMS.aspxhttp://www.imagineids.com/products/powerDMS.aspxhttp://www.chemsw.com/12197.htmhttp://www.mastercontrol.com/solutions/document_control_fb.htmlhttp://www.mastercontrol.com/solutions/document_control_fb.htmlhttp://www.knowledgetree.com/ -
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Vendor List Policy IQ
http://www.policyiq.com
Intelex http://www.intelex.com/document_control/index.h
tm
Policy Manager
http://www.mcnhealthcare.com/solutions/Policy-Manager-Software.html
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Specification Analysis
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Specification Analysis
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Specification Analysis
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Specification Analysis
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Selection of Finalists
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Selection of Finalists
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0.0
1.0
2.0
3.0
4.0
5.0
TechnologyPlatform
Security
Administrative
Documentation Features
Versioncontrol
Finance
CompanyInformation
Radar Summary
Policy Technologies
Zequel Technologies
SoftTech Health-CMSMaster Control
Intelex
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Final Selection
MasterControl Document Management Suitev. 6.0
Salt Lake City, UT
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MasterControlFeatures
Suite of applications for laboratory management
Uses MS Word as text editor and all of Words features
Tightly integrated with MS office applications includingPowerPoint, Excel, Visio etc.
Web based (Thin Client) workflow application managesinteraction with documents
Hardware requirements within our limitations
Email notification
Flexible document management process Organizers
Info Cards
Allowed sharing of documents between user groups
Flexible workflow
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MasterControlFeatures
Ease of document import
External web publication to non lab users
Documents can be hyperlinked and provided tonon lab users
PDF publishing module
Vendor responsiveness
User group
Updates/enhancements
We have driven several modifications
Binder
Version 8.2 is now implemented
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MasterControlFeatures
Training Module
Verification and documentation of employeereview of documents
Uses quizzes to assure understanding of documentcontent
Meets CAP and ISO 15189 requirements forannual employee review
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Implementation
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How to Get Started
Go slow
This is a project that runs over years
Select correct vendor
Purchase and implement system
Import current documents
Design a new template that will address ISO/CAP requirements
CLSI standard is a good point of departure
Examine current file, document nomenclature to assess whetherredesign
Examine inspection cycle relevant to implementation timeline
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Technical Requirements
Technical requirements link
Hardware and software requirements
Implemented on VM cluster Web server MS Internet Information server
Combined with PDF publisher
Polyserve MS SQL cluster
Supported on HFHS data center Tape Backup, snapshots, EMC NAS storage
http://localhost/var/www/apps/conversion/tmp/scratch_8/v7.0.x%20Hardware%20&%20Software%20Recommendations.dochttp://localhost/var/www/apps/conversion/tmp/scratch_8/v7.0.x%20Hardware%20&%20Software%20Recommendations.doc -
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Current Status at Henry Ford
Most documents have been imported in their originalform (over 3000)
Some laggards of course! Standard template for documents designed and
implemented
A standard nomenclature for document naming and
numbering has been designed and implemented Imported documents are now being place into
organizers
This is the first step to activating a division or
customer group
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Current Status at Henry Ford
Training for customers has been accomplished withlaboratory divisions
Now proceeding across other hospital locations
Documents for each completed organizer are placedon our intranet replacing prior document
Migrated to enterprise hardware
Upgraded to version 8.2 Implemented ISO compliant templates
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Current Status at Henry Ford
Backup systems in place
Networked PC in core lab area
Documents in MasterControl linked to our intranetwebsite
Controlled copies implemented
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ISO 15189 Document Process
Link to ISO Naming Conventions
Template Example
Document Structure:
http://localhost/var/www/apps/conversion/tmp/scratch_8/DOCUMENT%20CONTROL%20ORGTEMPLAT%20ES%20NAMING%205-13-10.pdfhttp://localhost/var/www/apps/conversion/tmp/scratch_8/temp_PolPro_combo.dochttp://localhost/var/www/apps/conversion/tmp/scratch_8/temp_PolPro_combo.dochttp://localhost/var/www/apps/conversion/tmp/scratch_8/DOCUMENT%20CONTROL%20ORGTEMPLAT%20ES%20NAMING%205-13-10.pdf -
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Document Structure:Relationship of Quality Documents
Document Type(Click on individual link to view document template) Description
Policy Statement of intent Derived from
- Established requirements, or
- organizational mandate
Describes what is done
Process Description of who does what and whenProvides information on how it happens
here. Typically a flow chart or table.
Procedure
Detailed procedure
Policy/procedure combo
Instructions for how to do a task within the
larger process
Forms/ Records Data, information, or results captured from performing aprocedure, recorded on a form, label, or tag, or entered
into a computer
Standard Work The current one best way to safely complete an activitywith the proper outcome and the highest quality
Each step in the process should be defined and must be
performed repeatedly in the same manner identifying
work components: Content, Sequence, Timing, Locationand Outcome
http://pathology.hfhs.org/train/templates/temp_policy.dochttp://pathology.hfhs.org/train/templates/temp_process.dochttp://pathology.hfhs.org/train/templates/temp_procedure.dochttp://pathology.hfhs.org/train/templates/temp_detailed%20procedure.dochttp://pathology.hfhs.org/train/templates/temp_polpro_combo.dochttp://pathology.hfhs.org/train/templates/temp_standardWork.dochttp://pathology.hfhs.org/train/templates/temp_standardWork.dochttp://pathology.hfhs.org/train/templates/temp_polpro_combo.dochttp://pathology.hfhs.org/train/templates/temp_detailed%20procedure.dochttp://pathology.hfhs.org/train/templates/temp_procedure.dochttp://pathology.hfhs.org/train/templates/temp_process.dochttp://pathology.hfhs.org/train/templates/temp_policy.doc -
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Quality System
Essential (QSE)PALM or
Hospital Division or
Medical
Center
Number Type Name + Suffix
LABEL (prefix) NAME
DOCUMENT
TITLE
:
TYPE OF DOCUMENTABBREVIATION
Policy pol
Process prs
Procedure pro
Standard Work stw
Checklist chk
Flow chart flcForm frm
Photograph pho
Power point ppt
Screen shot scr
Scanned document scn
Table tab
Video Vid
Quality
System
Essentials (QSE)
Abbreviation QSE
Number
Organization ORG 1.0
Personnel PER 2.0
Equipment EQM 3.0
Purchasing and Inventory PUR 4.0
Process Control PRC 5.0
Documents and Records DOC 6.0
Information Management INF 7.0
Occurrence Management OCC 8.0
Assessments:
External And Internal
ASM 9.0
Process Improvement PRI 10.0
Customer Service CUS 11.0
Facilities and Safety SAF 12.0
ISO Document Naming Convention
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ABBREVIATIONS IN DOCUMENT CONTROLHospital & Division Level Detail
HOSPITAL DIVISION ABBREVIATION
PALM = System-wide PALM PALM
Anatomic Pathology ANP
HFH
Henry Ford Hospital
Clinical Pathology CLP
HFMCT
Macomb Clinton
Point of Care Testing POC
HFMWC
Warren Campus
Microbiology MIC
HFWBH
West Bloomfield
Transfusion Medicine TRM
HFWH
Wyandotte Hospital
Chemistry CHM
HFCH
Cottage Hospital
Coagulation COA
HFMG
HF Medical Group
Core Lab COR
Cytopathology CYP
Hematology HEM
Immunology- Transplant IMM
Laboratory Service Center LSC
Laboratory Support Services LSS
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Demonstration
Screen shots from master control
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Questions?