Document Development and Document Control Quality Essentials for Safe Transfusion K' Gagliardi

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Document Development and Document
ControlQuality Essentials for Safe
TransfusionK. Gagliardi
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Overview

• Introduction and QUEST model
• Models from Literature
• Top 20 Questions
• Related Standards Requirements
• Questions we cant answer
• Conclusions/Lessons Learned

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Your questions about Documents
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What is the QUEST project?

• A 2 to 3 year research project
• Funded by the MOH - LTC
• Developing a quality system model in Transfusion
  Medicine based on new Health Canada standards
• Model will provide Ontario TM labs with validated
  templates
• Two Ontario locations Hamilton/Niagara and
  Ottawa

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Total Quality System
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Hamilton/Niagara-Current Activities

• Develop and pilot
• Laboratory processes and SOPs
• System for Document Control
• Blood administration guidelines
• Education training
• Non-conformance management (MERS-TM) and
  surveillance
• Centralized inventory,storage/transport/wastage

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TOPS-Transfusion Ontario Programs

• Blood conservation initiative by
• Ontario MOH LTC and OBSRG
• (Ontario Blood System reference Group)
• QUEST is found under The Programs at
  http//www.transfusionontario.org/
• Other programs ONTraC, Physician Education,
  Autologous, CIDP study, THJA and Turnkey Blood
  Conservation Program

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Model for Process ControlBerte and Lupo

• Identify Procedures
• Draft SOPs
• Validate Process
• Finalize SOPs
• Train, Assess competence
• Monitor process

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Model for Document DevelopmentModel Quality
System for Transfusion Medicine

• Decide if SOP/document required
• Draft SOP/Training Guides
• Determine relationship to process overview (are
  other SOPs affected? New ones needed)
• User Input/Interview/Shadowing
• Identify practice changes training

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Model for Document Development

• Training Communication Plan
• Approval formal signatures
• Distribution of new
• Archiving old
• Destruction of unnecessary copies

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Introducing..

• TOP
• 20
• Questions

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Question 1 What are Documents?

• SOP (e.g. Crossmatch)
• Method
• Policy (e.g. Indications Policy for Irradiated
  Products)
• Forms

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Policies, Processes, Procedures
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Question 2 What is a Quality Policy Statement?

• Forms the top of the document pyramid
• Forms the beginning of the documentation process
• Gives direction to the laboratory service quality
  operations
• Meaningful when reinforced and modeled to staff
• Best developed by a group involving all staff

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Quality Policy Transfusion Medicine October 2000

• Our purpose is to meet the needs and expectations
  of health care providers, patients and community
  in providing exemplary transfusion medicine
  service, education and research.
• Our commitment includes a quality management
  system using performance measures that are
  visible, challenging, and understandable and will
  provide for
• A continuous improvement process
• Front line staff involvement
• Safe, effective transfusion products and service
• Collaboration, coordination and advocacy

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Question 3Have you conducted a process analysis?

• What is a process analysis?
• A business oriented way to analyze operations and
  document the work activities
• Suited to identify SOP that are required
• Increases understanding of linkages with other
  departments
• Crosses traditional department and functional
  lines

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Process Analysis

• Flowcharting
• Input output
• Transfusion HRLMP example
• Incoming Blood Delivery (3 SOPs)
• Receiving of Inventory and Storage (6 SOPs)
• Manipulation of Components (gt10 SOPs)
• Transport and Issuing (4 SOPs)

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Question 4 Where do I start writing?

• Critical Control Points (CCPs)
• Process analysis will probably reveal lots of
  SOPs that need writing.. If not good!
• FDA e.g. identifies Compatibility testing as a
  system
• Sample collection is a CCP under that system
• Sample identification is a Key element ..
• Visual check is a control

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Question 5Any other issues to consider before
writing SOP starts?

• Existing procedures in the lab or other
  departments that are impacted by this SOP?
• Standards relevant to an SOP?
• Best practices that need to be implemented?
• New information of any kind regarding a product?
• LIS changes that need to be made

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Question 6How do I keep track of everything
involved?

• Change control process Z902 4.4.2.5
• a system shall be established and maintained to
  identify, document, review and approve all
  process changes
• Transitional planning a form
• Title Number Source documents, including
  original SOP LIS changes, communication
• Distribution locations orientation locations

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Question 7Help! Long list of SOPswhere do I
start again?

• Prioritization model HRLMP
• Need for standardization of practice, meeting
  standards
• (Transport/packing of blood coolers)
• Risk to patient
• (NAIT platelet production WB collection-Irradiat
  ion)
• Risk to staff
• (Emergency preparedness)
• New Methodology/instrumentation
• (Change in antibody detection method)
• Training

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Question 8 How do I organize my table of
contents? Keep track of old and new procedures?

• Table of contents path of workflow
• Patient, Specimen requirements
• Compatibility Testing SOPs and other Routine
  Methods
• Transfusion Reactions
• Quality Assurance

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Question 8Table of Contents? Master Index?

• Keep track of old and new procedures?
• Master index/list input all current titles using
  alphabetical listing (see example)
• Location (site specific or new), number important
• Key word locator or Software solution using
  Search type function
• Master file contains copies of new approved
  version of SOP, previous versions of drafts,
  transitional planning form

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Question 8 Numbering of procedures (training
unit)

• Grading Reactions 08 -345-200
• Preparing Red Cell Suspensions 08 345 201
• ABO Cell Testing 08 345 202
• ABO Plasma/Serum Testing 08 345 203
• ABO Grouping using Patients plasma at 4C
• 08 345 204
• ABO Discrepancy Workflow 08 345 205
• Saline Replacement 08 345 206
• ABO Discrepancies due to Acriflavin 08 345 207
• Subgroup of A with Anti-A1 08 345 208

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Question 9What Formats are acceptable?

• Okay, I know what Im going to write about what
  format should I use, what standards apply?
• Draft Z902 4.2.2.1 Check HRLMP for
• Name of facility
• Title and purpose of procedure
• Unique number identifying the document and
  revision
• Implementation date

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Question 9What Formats are acceptable?

• Signature of authorizing person and date of
  authorization
• Page number/pagination (e.g. page 5 of 9)
• Clear outline of steps and instructions which
  shall match the details in records
• Do you need to change? .Listen to users, staff
• Prepare templates to ease prep time
• Use of 2 templates Technical, Operating

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Question 10What are Standard Language
Guidelines?

• Do rules exist for certain expressions? Are
  styles used consistent?
• Consistency name of game
• Develop your guidelines, e.g., under Purpose
  short clear statement to describe steps required
  to wash RCC
• Train anyone who writes SOPs with guidelines
• Standards may provide helpful definitions

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Question 11Should SOP be long or short?

• Long or short SOPs should we be making these
  lengthy and include all (less titles)?
• Short many SOPs highly specific titles
  breakdown by process steps
• Short many titles to keep track of many SOPs
  impacted by change
• Training Units/Related procedures
• LIS steps in or out?

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Question 12Is the SOP ready to go?

• Do you think everyone will like it?
• No, youre not ready, and no, they will not like
  it
• User Input suffices for individual SOP
• If you are implementing an entire new Process
  however, Validation is more complex
• Definition Ensuring that a new method or
  instrument repeatedly does what you want it to
  under pre-defined conditions, using your process
• Validation perform Prior to implementation

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Question 12Is the SOP ready to go? Validation

• Validation Checklist -partial
• Purpose
• Description of System to be validated
• Responsibilities Installation qualification,
  Maintenance and calibration, support services
• Requirements SOPs, Personnel, equipment, other
  materials
• Test samples required, conditions, data,
  acceptance criteria
• Conclusions Acceptability of results

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Question 13What is Test Phase/User Input?

• No, really, how do you validate?
• Try to collect input from peers at draft stages
• Document the feedback
• SOP Improvement Form - suggestions on wording,
  related to specific steps
• Validation Documents a Mirror Copy of SOP final
  version signed off by individuals in the
  laboratory performing test runs

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Question 13 - Validation

• Validation of Implementing New Technology
• -Checking equipment and testing it under all
  conditions
• -Parallel testing using multiple scenarios
• -Planned, systematic approach

• Validation of a single SOP
• Documentation of responsible staff members
  piloting through each step by signing and dating
• Suggestions, corrections
• can be documented as well and implemented in
  Implementation Version SOP

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Question 14What are distribution locations?

• Do you place your SOPs in multiple locations?
• Distribution (controlled) locations must be
  identified in a quality environment
• Nursing stations HIS Laboratory reception
  Research studies
• Electronic systems helpful --- Paper a reality
• Version control - implementation date
• Uncontrolled copies
• Post Locations

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Question 14 Distribution Locations Example

• Number 7, 15, 23, 33, and 47 designated numbers
  for 5 Transfusion locations
• Stem Cell lab Procedure Operating the Control
  Rate Freezer 2 Supplied from Liquid Nitrogen
  Dewar 08 348 516 placed in Binder 47.5 (see
  Transitional Planning Form)
• Post Locations numbered separately need to
  display authorized copy of SOP in highly
  specific, designated locations

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Question 15Are SOP ready to circulate? Approval

• Has your SOP been formally approved?
• Decide who needs to approve -early
• Medical Director Transfusion Director
• Manager
• Other Technical representative Clinical
  representative
• Keep list to minimum

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Question 16What do I do with old procedures?

• Once new SOP placed in lab collect old ones
• Store in a designated location and system
• Paper or electronic
• Must be retrievable in reasonable time
• Memo used to communicate to
• Document control coordinator
• placing new documents and retrieving old ones for
  archiving

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Question 17What happens if brand new SOP needs
changes?

• Urgent or non urgent change
• Non urgent Collection of feedback for next
  version
• Urgent Immediate changes for critical omissions,
  errors, or change to product information
• Procedure Amendment form
• Produce a new version

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Question 18What roles do we need?

• Quality Manager/Coordinator puts Quality System
  plan in place
• Discipline Procedure Coordinator keeps one
  department procedure development going
• Document Control Coordinator places new
  documents in specified location, retrieves old
• Transfusion Technologist does all this and
  crossmatches too

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Question 19 What structures do we need?

• Transfusion Operations Committee review Ops,
  practice issues requiring clinical input
• Transfusion Committee subcommittee of MAC,
  clinical stakeholders
• Quality Council Laboratory wide representation
  advise on directions for Quality Plan
• TM Procedure team staff, Tech Spec, Manager

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Question 20What references are helpful?

• Draft Z902 CSA National Standards for Blood
  Safety
• Berte L., Lupo B. Quality in Blood Banking in
  Modern Blood Banking and Transfusion Practices,
  4th Edition (Harmening D.)
• A Model Quality System for Transfusion Medicine
  - AABB Ortho 1997
• AABB Standards 21st edition
• Nevalainen D., Berte L., Callery M. Quality
  Systems in the Blood Bank Environment, 2nd
  edition, 1998

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Related Z902 Standards

• Development/Approval and Distribution 4.2.2
• Change Control/Document Control process 4.2.3
• Distribution lists/locations 4.2.3.2
• Archiving - 4.2.4.1
• Process Validation - 4.4.2.3, 4.4.2.4
• Critical control points, SOP (implied Each
  activity that affects the quality and safety of a
  product) 4.2.1.1

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Relevant OLA Requirements

• Change Control IIA.2
• Document Control II.F, including Master Index
  II.F.4, Archiving II.F.6
• Process Validation II.A.2
• Process Analysis II.A.2
• Quality Policy Statement II.B.1 tp .5

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Questions we cant answer

• Should a whole region have the same system?
• How many dollars are available to implement a
  sustainable system? A system that meets
  standards?
• What roles will work in all laboratory services?
• Should typing be done by typists or
  technologists?
• What is the best software system to support all
  of this?

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Lessons Learned

• Titles are very important
• Master file tracking of where things are
  vital!
• Master Index staff must have this to deal with
  locating SOPs in a purely paper system
• Release training units of SOPs not one here,
  one there
• Constant change a challenge
• Communicate with staff, clinical contacts
  constantly

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Summary

• Document Development
• -Critical Control points
• -Process Analysis
• -Training concerns
• -User input
• -Validation
• -Approval

• Document Control
• -Numbering/identification
• -Version identification
• -Change Control
• -Master File
• -Master Index
• -Distribution system
• -Archiving

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Acknowledgements

• Diana Boye and Silvia Sunesen Quality
  Associates, QUEST - Hamilton
• Cathie McCallum, Quality Manager, HRLMP
• Beth Harriman (HRLMP) and Angela Fiorillo (QUEST)
  Administrative Coordinators
• Rosanne Frassetto and Sharon McMillan, Quality
  Associates, QUEST Niagara
• Pam OHoski, Connie Lester, Julie DiTomasso and
  Denise Evanovitch fellow Tech Specialists
• Nancy Heddle, Project Advisor, QUEST and Duane
  Boychuk, Manager, Transfusion Medicine HRLMP

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Total Quality System