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RAISING THE BAR

RAISING THE BAR. Meeting CSA Guidelines And Preparing for Health Canada Regulatory Requirements. Strategies for Preparing Applicable Standards / Regulations Program Preparation Documentation SOP manual essentials Worksheets / Forms / Reports Quality Management Discussion / Questions.

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RAISING THE BAR

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

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

  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

  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

  5. Program Preparation • Literature review • standards • other facilities • Senior Management commitment • resources / frontline commitment • Workshop • FACT (ISCT / ASBMT)

  6. 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

  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

  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

  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

  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

  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

  12. Safety • Staff • Competency Assessment • Orientation with objectives • Adequate staffing ratio • Personal protective equipment • Isolation Policies

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

  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

  15. Program Preparation • Labels • collection / processing / transport • label release • Quality Management / Safety • procedures/equipment/reagents/personnel • facility program

  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

  17. 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

  18. 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

  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

  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

  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?

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