1. RAISING THE BAR Meeting CSA Guidelines And Preparing for Health Canada
Regulatory Requirements

2. Presentation Overview
Strategies for Preparing
Applicable Standards / Regulations
Program Preparation
Documentation
SOP manual essentials
Worksheets / Forms / Reports
Quality Management
Discussion / Questions

3. Applicable Standards / Regulations
Health Canada – Directive (Jan 2003)
CSA Guidelines (July 2003)
FACT Standards (2nd Edition 2002)
AABB Standards (3rd Edition 2002)
GMP / GLP Guidelines
Most recent standards – may seem intimidating but once reviewed all standards have basic similarities. Difference between standards and regulations. Voluntary vs mandatory (law) / loss of accreditation vs program closure

4. Scope of Standards Policy and procedure requirements
SOP manual
Terminology, definitions
Technical requirements
Quality Management
Quality Control, Quality Assurance, Quality Improvement, Quality Assessment
Safety
Mentioned all standards have similar elements

5. Program Preparation Literature review Senior Management commitment
standards
other facilities
Senior Management commitment
resources / frontline commitment
Workshop
FACT (ISCT / ASBMT)
Some of the steps our facility used to prepare for accreditation

6. Program Preparation Set up regularly scheduled meetings Develop plan
communication link (clinical/collection/laboratory)
action list: who/what/when
Requirement in the standards
Develop plan
Educate staff / commitment from key members
Initial planning steps. Commitment form key members should include some form of quality training

7. Program Preparation Develop an Organizational Chart
Important to establish/formalize reporting
structure
Must identify a single Program Director
All programs clinical, collection and
laboratory programs must report ultimately to the
Program Director
Develop an Organizational Mission
Job Descriptions
Some of the steps our facility used to prepare for accreditation

8. Clinical Program Preparation
Identify and meet with all departments
outside BMT program that are involved in
patient care OR
ICU
Emergency
Inpatient/outpatient areas
Blood Bank
Some of the steps our facility used to prepare for accreditation

9. Safety Recipient Must have identified & adequate stem cell source
available
If Allogeneic Transplant donor suitability must be
documented prior to initiating conditioning regimen
Chemotherapy administration SOP
Pretyped chemotherapy orders
Standard Protocols or REB approval
SOP for product infusion
Some of the steps our facility used to prepare for accreditation

10. Safety Recipient Competent staff
Availability of Emergent/Intensive Care
Protective environment if necessary
24 hour Blood Bank, Pharmacy services
Consent to collect and share information
Some of the steps our facility used to prepare for accreditation

11. Safety Donor Confidentiality Consent to donate, receive growth factors
Written criteria for evaluation and acceptability
Endpoints for donation
Donor follow-up
Consent to collect and share information
Some of the steps our facility used to prepare for accreditation

12. Safety Staff Competency Assessment Orientation with objectives
Adequate staffing ratio
Personal protective equipment
Isolation Policies
Some of the steps our facility used to prepare for accreditation

13. Program Preparation SOP development SOP for SOP writing
map existing SOP against standards (gap analysis)
create / modify SOPs
validate / implement
document control
Major commitment to achieve compliance with any standards – actual compliance inspection will center around SOPs and worksheets to demonstrate compliance

14. Program Preparation Form / Report Development
demonstrate communication link
physician request form
collection report
processing data report
issue request
transport report
infusion report
outcome measurement/engraftment data/performance indicators
Demonstrate communication link – why? Product quality linked to various steps – clinical (patient preparation) collection (incidents during collection might affect product) laboratory (data from lab could affect patient engraftment and future collections)

15. Program Preparation Labels Quality Management / Safety
collection / processing / transport
label release
Quality Management / Safety
procedures/equipment/reagents/personnel
facility program
Labels – national Canadian label process?

16. Program Preparation Data Management Program must keep data
Necessary for outcome evaluation
Database: commercial / in house
Electronic Forms
Build in safety checks
Quality Assurance Audits of Database
Security Issues
Password protected
Report creation / performance indicators
Labels – national Canadian label process?

17. Documentation SOP Essentials
SOP for SOPs – standardized format
Title, version #, effective date
Purpose
Equipment / supplies
Objectives / acceptable end-points
References
Detailed work instruction
Approval / review
Form / worksheet examples
Worksheets / forms / reports
Standardized format, outlined in SOP for SOPs
Document control – keep it simple, especially for smaller Canadian programs (give examples CBS vs hospital)

18. Documentation SOP Essentials
SOP Manual
Technical (ie. HPC-A plasma reduction)
Quality Management (ie. Performance Measurement)
Document control
Copy #, Copy location
Revision process
review process – director / staff

19. Quality Management
Quality Management – an integrated program of Quality Control / Quality Assurance / Continuous Quality Improvement / Quality Assessment
QC – determines accuracy and reliability of a process
QA – describes actions taken to provide confidence process is working
CQI – describes actions taken to review and improve quality
QAssessment – describes actions to evaluate process
Quality buzz words – brief definitions. Smaller programs have to stick to the basics.

20. Quality Management Quality Program – 3 levels
Level 1 - Quality Management Plan
What are we planning to do
Level 2 – Quality Management Operating Procedures
How are we going to accomplish our plan
Detailed work instructions for processes related to quality issues
Level 3 – Quality Documentation
How did we accomplish our plan
Forms / worksheets: documented proof for compliance

21. Quality Management Quality Management Program
Equipment, reagents, procedures, personnel
initial validation, annual verification/certification
demonstrate control/compliance through documentation
Performance Reports (Outcome Measurement)
monitor/analyze data to ensure quality
engraftment/microbial contamination/incidents/
processing endpoints/infusion reactions
Performance reporting – what our lab does. Standards stipulate engraftment data as a minimum. A national standardized system would be beneficial – CBMTG technologist committee / CBMTG registry database. Reviewing data is really not enough – should be able to compare data between facilities.

22. Quality Management Audits Errors/Incidents
process to document/review/analyze/corrective actions
Performance Reports (Outcome Measurement)
monitor/analyze data to ensure quality
engraftment/microbial contamination/incidents/
processing endpoints/infusion reactions
Meetings/minutes
program communication

23. Quality Management Documentation & Record Keeping
Key Element in Quality Management
Activities not documented are considered not to have been performed
Must occur at the time the activity takes place and be kept as part of a permanent record
Must be done by the individual performing the activity

24. Quality Management in the Clinical Program
Validation
Establishes documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes

25. Validating Processes in the Clinical Setting
New processes initiated without established literature reference should be validated
PICC’s in BMT patients
Pumping of cryopreserved products
Sometimes it is prudent to have REB approval

26. Discussion / Questions
Why are we doing this?
Quality improvement – client focus
Canadian regulations
Ensure/improve quality of program
How are we going to do this?
Resources? (financial / staff / expertise)
National initiatives / support
Questions?
Why – patients expectations. Suggestions for national initiatives