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

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  • RAISING THE BARMeeting CSA GuidelinesAndPreparing for Health CanadaRegulatory Requirements

  • Strategies for PreparingApplicable Standards / RegulationsProgram PreparationDocumentationSOP manual essentialsWorksheets / Forms / ReportsQuality ManagementDiscussion / Questions

    Presentation Overview

  • Applicable Standards / RegulationsHealth Canada Directive (Jan 2003)CSA Guidelines (July 2003)FACT Standards (2nd Edition 2002)AABB Standards (3rd Edition 2002)GMP / GLP Guidelines

  • Scope of StandardsPolicy and procedure requirementsSOP manualTerminology, definitionsTechnical requirementsQuality ManagementQuality Control, Quality Assurance, Quality Improvement, Quality AssessmentSafety

  • Program PreparationLiterature reviewstandardsother facilitiesSenior Management commitmentresources / frontline commitmentWorkshopFACT (ISCT / ASBMT)

  • Program PreparationSet up regularly scheduled meetingscommunication link (clinical/collection/laboratory)action list: who/what/whenRequirement in the standardsDevelop planEducate 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

  • SafetyRecipient 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 PreparationSOP developmentSOP for SOP writingmap existing SOP against standards (gap analysis)create / modify SOPs validate / implementdocument control

  • Program PreparationForm / Report Developmentdemonstrate communication linkphysician request formcollection reportprocessing data reportissue requesttransport reportinfusion reportoutcome measurement/engraftment data/performance indicators

  • Program PreparationLabelscollection / processing / transportlabel releaseQuality Management / Safetyprocedures/equipment/reagents/personnelfacility program

  • Program PreparationData ManagementProgram must keep data Necessary for outcome evaluationDatabase: commercial / in houseElectronic Forms Build in safety checksQuality Assurance Audits of DatabaseSecurity Issues Password protectedReport creation / performance indicators

  • SOP for SOPs standardized formatTitle, version #, effective datePurposeEquipment / suppliesObjectives / acceptable end-pointsReferencesDetailed work instructionApproval / reviewForm / worksheet examplesWorksheets / forms / reportsStandardized format, outlined in SOP for SOPs

    DocumentationSOP Essentials

  • DocumentationSOP Essentials

    SOP ManualTechnical (ie. HPC-A plasma reduction)Quality Management (ie. Performance Measurement)Document controlCopy #, Copy locationRevision processreview process director / staff

  • Quality Management

    Quality Management an integrated program of Quality Control / Quality Assurance / Continuous Quality Improvement / Quality AssessmentQC determines accuracy and reliability of a processQA describes actions taken to provide confidence process is workingCQI describes actions taken to review and improve qualityQAssessment describes actions to evaluate process

  • Quality Management

    Quality Program 3 levelsLevel 1 - Quality Management PlanWhat are we planning to doLevel 2 Quality Management Operating ProceduresHow are we going to accomplish our planDetailed work instructions for processes related to quality issuesLevel 3 Quality DocumentationHow did we accomplish our planForms / worksheets: documented proof for compliance

  • Quality Management

    Quality Management ProgramEquipment, reagents, procedures, personnelinitial validation, annual verification/certificationdemonstrate control/compliance through documentationPerformance Reports (Outcome Measurement)monitor/analyze data to ensure qualityengraftment/microbial contamination/incidents/ processing endpoints/infusion reactions

  • Quality Management

    AuditsErrors/Incidentsprocess to document/review/analyze/corrective actionsPerformance Reports (Outcome Measurement)monitor/analyze data to ensure qualityengraftment/microbial contamination/incidents/ processing endpoints/infusion reactionsMeetings/minutesprogram communication

  • Quality Management

    Documentation & Record KeepingKey Element in Quality ManagementActivities not documented are considered not to have been performedMust occur at the time the activity takes place and be kept as part of a permanent recordMust be done by the individual performing the activity

  • Quality Management in the Clinical Program

    ValidationEstablishes 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 validatedPICCs in BMT patientsPumping of cryopreserved productsSometimes it is prudent to have REB approval

  • Discussion / QuestionsWhy are we doing this?Quality improvement client focusCanadian regulationsEnsure/improve quality of programHow are we going to do this?Resources? (financial / staff / expertise)National initiatives / supportQuestions?

    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 closureMentioned all standards have similar elementsSome of the steps our facility used to prepare for accreditationInitial planning steps. Commitment form key members should include some form of quality trainingSome of the steps our facility used to prepare for accreditationSome of the steps our facility used to prepare for accreditationSome of the steps our facility used to prepare for accreditationSome of the steps our facility used to prepare for accreditationSome of the steps our facility used to prepare for accreditationSome of the steps our facility used to prepare for accreditationMajor commitment to achieve compliance with any standards actual compliance inspection will center around SOPs and worksheets to demonstrate complianceDemonstrate 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)Labels national Canadian label process?Labels national Canadian label process?Document control keep it simple, especially for smaller Canadian programs (give examples CBS vs hospital)Quality buzz words brief definitions. Smaller programs have to stick to the basics.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.Why patients expectations. Suggestions for national initiatives