The Royal Marsden
Nursing and Service Aspects of
Extracorporeal Photopheresis
( ECP)
Janet Baker (Sister-Haem-Onc Daycare/Outpts/Apheresis)
Royal Marsden NHS Foundation Trust
1
EBMT NAP UK
5/10/2012
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The Royal Marsden
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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The Royal Marsden
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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The Royal Marsden
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
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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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The Royal Marsden
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
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Baseline GvHD assessment and I/S medication review
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Patient Consent / Information
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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
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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?
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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.
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Questions?
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References
 FACT-JACIE International Standards for Cellular
Therapy Product Collection, Processing, and
Administration. 5th edition. JACIE