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 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

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

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

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

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

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

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

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

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

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

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

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)

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?

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?

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)

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

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.

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 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.

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? Why – patients expectations. Suggestions for national initiatives