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

1
Document Development and Document
ControlQuality Essentials for Safe
TransfusionK. Gagliardi
2
Overview

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

3
Your questions about Documents
4
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

5
Total Quality System
6
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

7
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

8
Model for Process ControlBerte and Lupo

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

9
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

10
Model for Document Development

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

11
Introducing..

• TOP
• 20
• Questions

12
Question 1 What are Documents?

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

13
Policies, Processes, Procedures
14
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

15
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

16
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

17
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)

18
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

19
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

20
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

21
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

22
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

23
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

24
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

25
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

26
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

27
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

28
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?

29
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

30
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

31
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

32
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

33
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

34
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

35
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

36
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

37
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

38
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

39
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

40
Question 20What references are helpful?

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

41
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

42
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

43
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?

44
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

45
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

46
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

47
Total Quality System