RAISING THE BAR

Meeting CSA Guidelines

And

Preparing for Health Canada

Regulatory Requirements

Presentation Overview

• Strategies for Preparing– Applicable Standards / Regulations– Program Preparation

• Documentation– SOP manual essentials– Worksheets / Forms / Reports

• Quality Management• Discussion / Questions

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

Scope of Standards

• Policy and procedure requirements– SOP manual

• Terminology, definitions• Technical requirements• Quality Management

– Quality Control, Quality Assurance, Quality Improvement, Quality Assessment

• Safety

Program Preparation

•Literature review–standards–other facilities

•Senior Management commitment–resources / frontline commitment

•Workshop–FACT (ISCT / ASBMT)

Program Preparation

• Set up regularly scheduled meetings– communication link (clinical/collection/laboratory)– action list: who/what/when– Requirement in the standards

• Develop plan• Educate staff / commitment from key members

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

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

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

SafetyRecipient

– Competent staff– Availability of Emergent/Intensive Care– Protective environment if necessary– 24 hour Blood Bank, Pharmacy services– Consent to collect and share information

SafetyDonor

– 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

SafetyStaff

– Competency Assessment– Orientation with objectives– Adequate staffing ratio– Personal protective equipment– Isolation Policies

Program Preparation

• SOP development– SOP for SOP writing– map existing SOP against standards (gap analysis)– create / modify SOPs – validate / implement– document control

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

Program Preparation

• Labels– collection / processing / transport– label release

• Quality Management / Safety– procedures/equipment/reagents/personnel– facility program

Program PreparationData 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

DocumentationSOP 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

DocumentationSOP 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

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 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

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

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

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

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

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

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?