Janet Baker - EBMT UK NAP
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Transcript Janet Baker - EBMT UK NAP
The Royal Marsden
Nursing and Service Aspects of
Extracorporeal Photopheresis
( ECP)
Janet Baker (Sister-Haem-Onc Daycare/Outpts/Apheresis)
Royal Marsden NHS Foundation Trust
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EBMT NAP UK
5/10/2012
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Background
Opportunity to deliver ECP at RMH
Commercially sponsored clinical trial: ECP for 1st line
Chronic GvHD
Provision of CellEx™ Photopheresis system
Charity funded programme for Acute GvHD
Development of an ECP service
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Discussion Points
Clinical Governance Issues
Management, Organisation, and Personnel
Training and Supervision
Premises-Space-Storage
Key Documentation
Quality Assurance/ Standards
Patient Management
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Clinical Governance Issues
Service Objectives / Outcome
Service Agreements/ Maintenance
New Equipment User Group
Drug and Therapeutics Committee-Approval for 8Methoxypsoralen (Uvadex™)
Risk Assessment
Incident Reporting System
Procurement
Finance Reporting- updates to Charity Fund
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Management, Organisation, and Personnel
? Extension / Integration of Apheresis service
Inpatient / outpatient service
Designated leads/ Keyworkers: Nursing and Medical
Accountability / Responsibility
Skill mix / Experience: Apheresis + Transplant
Resources: Nursing Staff and Time
Institutional / Department support
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Training Requirements
Technical Competency Certificate from Company Trainer –
‘water treatment’ and patient treatments
Theoretical component- workbook
Arranged observational visit to Nottingham -ECP
Strasbourg- Company HQ, and clinical observational visit
On- the – job training / learning….ongoing
Instruction Manual
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Premises – Space - Storage
CellEx™
Location of procedure – Inpt/ Outpt/ Apheresis
Therapeutic environment
Service is portable
Storage of kits
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Key Documentation
Standard Operating Procedure ( SOP) for ECP
Patient Consent Form
Patient Information Leaflet
Photopheresis Procedure record
Prescription/ Proforma -Uvadex™ / Heparin
GvHD monitoring/ assessment form
FACT-BMT Quality of Life questionnaire
Reporting forms for System failures/Incidents
Maintenance and Cleaning records
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Quality Assurance / Standards
SOP policy for ECP and associated policies
JACIE accredited centre
JACIE 5th edn standards B7.2 acknowledge:
- “Inspectors are encountering ECP processes
during inspection-if part of therapy for GvHDmust comply with JACIE standards-performed
according to policies for safe administration of
ECP”
UK Photopheresis Society (UKPS) advocates ECP
accreditation in UK / Europe by external assessment
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Patient Management
Patient selection / Eligibility for treatment – SOP
‘ to ECP or not to ECP?’
Further consensus guidelines for acute GvHD needed
Scheduling –treatment efficacy -Acute –twice weekly-8 wks
- Chronic- per trial / 2x week every 2 weeks
- logistics and practicalities
Clinical pre-assessment criteria-blood values (Fbc, Coag,
U&es, Lfts, lipids) / Weight
Baseline GvHD assessment and I/S medication review
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Patient Consent / Information
Commitment / Compliance
Repeat hospital visits
Inpt/ Outpt
Realistic aims and timeframes- not ‘quick fix’
Support / Reassurance
Low fat diet- ( lipids)
UVA protection skin / eyes - dark glasses
Contraception – (Uvadex ™)
Good oral hydration
Acute/ Chronic GvHD pts… different needs
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Side –effect profile
Fatigue
Hypotension / dizziness/ syncope - ECV
Increased sensitivity to sunlight- skin / eyes
Pain, anxiety, bruising – peripheral cannulation
Infection- central access lines
Bleeding/ bruising – anticoagulation
Metallic taste in mouth , ‘sparkly’ sensation in eyes
during re-infusion
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Venous access - vein assessment
Peripheral Access– Kimal needle size 16/17
- 17/18 g cannula
Return - 18/ 20 g cannula
Central Line –Double lumen
- LTS line(long term silicone,tunnelled)
- 12 French ( 5.5 mm per lumen)
- > 3 French per lumen
- provide flow rates > 15 ml/ min
CellEx™ - Single or Double lumen procedure
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Transfusion Requirements pre ECP
Institutional Parameters
Hct > 27 %
Platelets > 25,ooo
Blood results < 48 hours pre procedure
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Anticoagualtion
System licensed for Heparin not Citrate
? Anticoagulant not anti-platelet clumping activity
10,ooo units Heparin in 500 mls / AC ratio 10:1
Adjust for high/ low platelet counts
Watch for Platelet Clumping
Assess for bleeding, bruising - haematuria
Patient anti-coag history- INR
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Technical problems
CellEx™ Alarms
Problem solving
Technical support - Hotline / UK trainer
Kits - Reimbursement if problems
Smart Cards- send for analysis
Reporting / Documenting System and kit problems
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Assessment, Monitoring, Evaluation
Efficacy v toxicity of treatment - ECP good safety
profile
GvHD assessments - who should complete these?
Record Clinical Outcomes - ? National ECP database
Quality of Life information
Financial Outcomes - Commissioners / Reimbursement
and future funding
Evidence -based and cost- effective service
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Our experience so far…….
3 AGvHD patients treated- 1 in treatment
CGvHD Trial - 1 pt enrolled- not randomised to ECP
? Future after funding/ trial complete
Challenging / time-consuming
Great opportunity for us and our patients
Collaboration and networking with other ECP centres
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Acknowledgement / Thanks
Regina De Jesus - Joint ECP Key- worker
- Sister, Transplant Unit, RMH
Nurses on Bud Flanagan Ambulatory Care ( BFAC)
ECP experts, esp - Emma Luke at Nottingham
- Tracy Maher and Maggie Foster at
Rotherham
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Thank You for listening.
–
Questions?
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References
FACT-JACIE International Standards for Cellular
Therapy Product Collection, Processing, and
Administration. 5th edition. JACIE