RENAL TRANSPLANT NATIONAL OPERATING PROCEDURE
NOP005 Activities To Be Performed Under The Guidance Of
A Registered Medical Practitioner in Deceased and
Living Donation and Transplantation
This National Operating Procedure replaces: NEW
Effective: July 2012 Review date: July 2014
Summary of Significant Changes
N/A
Policy
To ensure quality and safety, the European Union Directive 2010/53/EU stipulates that the healthcare personnel involved at all stages of the chain from donation to transplantation, or disposal, are suitably qualified or trained, and competent.
Specific medical activities in the organ donation and transplantation process must be performed under the advice and guidance of a Registered Medical Practitioner (RMP).
The responsibility for the defined medical activities lies with the RMP.
Purpose
The purpose of this document is to outline the medical procurement and transplantation activities that must be performed under the advice and guidance of a RMP, and the responsibilities of non-medical personnel who undertake medical activities.
Text in this document which is underlined is a mandatory requirement under the Quality and safety of organs for transplantation regulations 2012.
Page 1 of 12

RENAL TRANSPLANT NATIONAL OPERATING PROCEDURE
NOP005 Activities To Be Performed Under The Guidance Of
A Registered Medical Practitioner in Deceased and
Living Donation and Transplantation
Responsibilities
Non-medical healthcare personnel To undertake medical activities in accordance with national and local organisational policy and procedures, and adhering to their professional codes of conduct. To seek advice and guidance as required.
Registered Medical Practitioner: To provide advice and guidance when required on specific medical activities .
Definitions
Deceased donation - means organ donation from a deceased donor
EU Directive/European Union Directive - means Directive 2010/53/EU of the European
Parliament and of the Council 7 July 2010 on standards of quality and safety of human organs intended for transplantation
Implanting Surgeon - means the surgeon responsible for performing the transplant operation
Living Donation - means organ donation from a living donor
Living Donor Coordinator (LDC) - means a Specialist Nurse with the relevant knowledge, skills and training in living donation and transplantation
Medical Activities - means procurement or transplantation activities as defined in section
2 of this document
NLDKSS - means National Living Donor Kidney Sharing Schemes, to include paired/pooled donation, altruistic donation and altruistic donor chains
Non-medical personnel - means a member of the healthcare team who is not a registered medical practitioner. This may include, but not be limited to, the Living Donor
Coordinator (LDC), the Recipient Centre Point of Contact (RCPoC), the Specialist Nurse -
Organ Donation (SN-OD), the Scrub Practitioner
Recipient Centre Point of Contact (RCPoC) - means the healthcare professional responsible for communicating information to the implanting surgeon for a final decision to be made on accepting an organ for transplant
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RENAL TRANSPLANT NATIONAL OPERATING PROCEDURE
NOP005 Activities To Be Performed Under The Guidance Of
A Registered Medical Practitioner in Deceased and
Living Donation and Transplantation
Registered Medical Practitioner (RMP) - means a medical practitioner who is registered and with a licence to practice by the General Medical Council
Retrieving surgeon - means the lead retrieval surgeon
Scrub Practitioner - means a healthcare professional who assists the surgeons and facilitates the organ retrieval
Specialist Nurse Organ Donation (SN-OD) - means a Specialist Nurse with the relevant knowledge, skills and training in organ donation, working within NHSBT Organ Donation
Services Teams (ODST)
Applicable Documents
Directive 2010/53/EU of the European Parliament and of the Council 7 July 2010 on standards of quality and safety of human organs intended for transplantation
NOP001 Donor and Organ Characterisation, Assessment and Allocation in Deceased and Living Donation and Transplantation
NOP002 Verification of Donor Identity, Consent/Authorisation and Organ and Donor
Characterisation in Deceased and Living Donation and Transplantation
NOP003 Packaging, Labelling and Transport of Organs for Transplantation in Deceased and Living Donation and Transplantation
NOP004 Management of Procurement Material and Equipment in Deceased and Living
Donation and Transplantation
NOP006 Transfer And Storage Of Donor And Organ Characterisation Information and
Storage Of Traceability Data
Serious adverse event and reaction reporting for organs intended for transplantation -
Guidance for licence holders, 2012, Human Tissue Authority, www.hta.gov.uk
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RENAL TRANSPLANT NATIONAL OPERATING PROCEDURE
NOP005 Activities To Be Performed Under The Guidance Of
A Registered Medical Practitioner in Deceased and
Living Donation and Transplantation
The Quality and Safety of Human Organs Intended for Transplantation - a documentary framework, 2012, Human Tissue Authority, www.hta.gov.uk
1 INTRODUCTION
1.1 Specific activities in the organ procurement and transplantation process are designated medical activities. Medical activities must be performed under the advice and guidance of a registered medical practitioner (RMP). In practice, some medical activities are performed by non-medical personnel. The RMP may or may not be present.
1.2 Working with or without direct supervision, non-medical personnel must

only undertake medical activities in accordance with national and local organisational policies and procedures

adhere to their professional codes of conduct

only undertake medical activities in line with the roles and responsibilities defined in their job description, and agreed with their line manager

be suitably qualified or trained, and competent to perform the medical activity.
Relevant competencies may be assumed from status as a qualified healthcare professional or as per appendices to this SOP

make limitations to their competence, and any training needs, known to their line manager

seek advice and guidance immediately from a registered medical practitioner in the event of a problem, or other extraordinary circumstances

report any serious adverse event or reaction in accordance with the requirements detailed in Serious adverse event and reaction reporting for organs intended for transplantation - Guidance for licence holders, and their employing authority incident reporting mechanism.
1.3 The person responsible for performing a specific medical activity must be identified and agreed before the activity begins.
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RENAL TRANSPLANT NATIONAL OPERATING PROCEDURE
NOP005 Activities To Be Performed Under The Guidance Of
A Registered Medical Practitioner in Deceased and
Living Donation and Transplantation
1.4 Further guidance on procurement and transplantation activities is provided in the
National Operating Procedures as listed on page 2 of this document.
2 MEDICAL ACTIVITIES TO BE PERFORMED UNDER THE ADVICE AND GUIDANCE
OF A REGISTERED MEDICAL PRACTITIONER - DECEASED DONATION
Medical Activity
Scope of the Activity performed by Non-medical
Personnel
Advice and Guidance to be sought from
Review and interpretation of donor and organ characterisation information and data
The SN-OD collates information and data at the donor hospital to assist donor characterisation
The RCPoC receives information and data from the SN-OD, and from
NHSBT Duty Office, and relays information and data to the implanting surgeon
Implanting surgeon and/or retrieving surgeon
Implanting surgeon and/or retrieving surgeon
Inspection and assessment of the organ at the time of retrieval
Surgical retrieval of an organ
Performed by RMP
Flushing an organ with preservation solution
Packing the organ for transport
Performed by RMP
The Scrub Practitioner or
SN-OD will flush the organ(s) during the retrieval process
The Scrub Practitioner or
SN-OD will package the organ(s) for transport to the recipient centre
Surgical implantation of an organ Performed by RMP
Not applicable
Not applicable
Retrieving surgeon
Retrieving surgeon
Not applicable
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RENAL TRANSPLANT NATIONAL OPERATING PROCEDURE
NOP005 Activities To Be Performed Under The Guidance Of
A Registered Medical Practitioner in Deceased and
Living Donation and Transplantation
3 MEDICAL ACTIVITIES TO BE PERFORMED UNDER THE ADVICE AND GUIDANCE
OF A REGISTERED MEDICAL PRACTITIONER - LIVING DONATION
Medical Activity
Scope of the Activity performed by Non-medical
Personnel
Advice and Guidance to be sought from
The LDC collates information and data to assist donor characterisation
Allocated RMPs for the donor and the recipient
Review and interpretation of donor and organ characterisation information and data
Where organs travel from a donating centre to a recipient centre (e.g. in
NLDKSS, or from an adult to a paediatric facility), the
LDC/RCPoC in each centre will exchange information and data, and relay it to the retrieving and implanting surgeons.
Implanting and/or
Retrieving surgeon
Inspection and assessment of the organ at the time of retrieval
Surgical retrieval of an organ
Performed by RMP Not applicable
Flushing an organ with preservation solution
Packing the organ for transport
Performed by RMP
The LDC or Scrub
Practitioner may flush the organ(s) during the retrieval process
The LDC or Scrub
Practitioner may package the organ(s) for transport to the recipient centre
Not applicable
Retrieving or implanting surgeon
Retrieving surgeon
Surgical implantation of an organ Performed by RMP
4 IMPLEMENTATION AND AUDIT
Not applicable
4.1 The National Operating Procedures (NOPs) are available to download from the Human
Tissue Authority (HTA) website at www.hta.gov.uk
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RENAL TRANSPLANT NATIONAL OPERATING PROCEDURE
NOP005 Activities To Be Performed Under The Guidance Of
A Registered Medical Practitioner in Deceased and
Living Donation and Transplantation
.
4.2 Transplant Units may

Adopt the NOPs fully

Adopt the NOPs with local adaptation

Write their own procedural documents
4.3 If the NOPs are not fully adopted, Transplant Units must ensure that local procedures are compliant with the requirements of the EU Directive and in accordance with the regulatory framework of the HTA: The Quality and Safety of Human Organs Intended for Transplantation - a documentary framework.
4.4 Accountability for the NOPs and their implementation will lie with each individual
Transplant Unit.
4.5 Transplant Units will be responsible for

Implementation of the NOPs according to local Trust/Board policy

Document review according to local Trust/Board policy, and in response to developments in organ donation and transplantation practice, or changes in national policy or guidance

Document control

Staff training
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RENAL TRANSPLANT NATIONAL OPERATING PROCEDURE
NOP005 Activities To Be Performed Under The Guidance Of
A Registered Medical Practitioner in Deceased and
Living Donation and Transplantation
Transplant surgery

TS1 All Surgical consultant staff who are registered medical practioners, on the UK specialist register for general surgery and/or transplant surgery, appointed on a locum or substantive basis and subject to NHS GG&C appraisal/revalidation processes are assumed to be competent in all roles of the Registered medical practitioner as applied to transplantation and organ donation activity taking place within NHS GG&C. Specifically this includes living donation surgery, deceased donation surgical activity, living and deceased donor transplantation in adults and children. NHSGG&C appraisal includes formal assessment and documentation of clinical training, operative procedures performed, outcomes, complications, complaints and continuous professional development.
Satisfactory appraisal (SOAR) constitutes a formal demonstration of competency and CPD.

TS2 All Surgical trainee-grade staff who are registered medical practioners, in general surgery and/or transplant surgery, appointed on a locum or substantive basis and subject to NHS GG&C and or deanery appraisal/in-training assessment processes are assumed to be competent to undertake roles of the Registered medical practitioner as applied to transplantation and organ donation activity taking place within NHS GG&C under the clinical supervision (direct or remote) of RMP’s meeting the criteria set out in TS1. Specifically this includes living donation surgery, deceased donation surgical activity, living and deceased donor transplantation in adults and children.

TS3 A list of staff fulfilling the criteria for TS1 will be maintained in NOP005 Supplement 2: Log of
Qualified staff for the purposes of organ donation and transplantation activity.
Page 8 of 12

RENAL TRANSPLANT NATIONAL OPERATING PROCEDURE
NOP005 Activities To Be Performed Under The Guidance Of
A Registered Medical Practitioner in Deceased and
Living Donation and Transplantation
Anaesthesia of the transplant patient or organ donor

ANAES1 All Anaesthetic consultant staff who are registered medical practioners, on the UK specialist register for anaesthesia, appointed on a locum or substantive basis, subject to NHS
GG&C appraisal/revalidation processes and who regularly perform anaesthesia for transplantation or organ donation are assumed to be competent in all roles of the anaesthetist as applied to transplantation and organ donation activity taking place within NHS GG&C. Specifically this includes anaesthesia for living donation surgery, deceased donation surgical activity, living and deceased donor transplantation in adults and children. NHSGG&C appraisal includes formal assessment and documentation of clinical training, clinical performed, outcomes, complications, complaints and continuous professional development. Satisfactory appraisal (SOAR) constitutes a formal demonstration of competency and CPD.

Anaesthetic training is competence-based, in line with other specialties. Competencies are achieved and assessed throughout training. At the end of training, doctors are accredited and able to apply for consultant posts. A detailed description of this process can be found in the attached document from the Royal College of Anaesthetists (TRG-CU-CCT Anaes 2010.pdf).
Anaesthesia for renal transplantation is specifically designated as an area in which competence must be achieved, usualy during Intermediate Level Training which comprises ST years 3 and 4. Details can be found in attached document TRG-CCT Annex C, which covers the period of Intermediate
Training. In that document, the relevant applied physiology and biochemistry are discussed on page
66 and the relevant clinical competencies and assessment process on page 23.
All consultant anaesthetists covering the Western Infirmary emergency rota are accredited by the
Royal College of Anaesthetists. Their accreditation documents confirm their competence in anaesthetising patients for renal transplants. Overnight trainee cover of that rota is always by a Senior or Intermediate Level trainee. These trainees are supervised by consultants when they anaesthetise patients for renal transplants initially and then progress to managing suitable patients unsupervised.
This is as per the Royal College recommendations about "spiral learning". Detailed records of trainee progress (and assessments) are kept by College Tutors in the Western Department of Anaesthetics.

ANAES2 All Anaesthetic trainee-grade staff who are registered medical practioners, in anaesthesia, appointed on a locum or substantive basis and subject to NHS GG&C and or deanery appraisal/in-training assessment processes are assumed to be competent to undertake roles of the
Registered medical practitioner as applied to anaesthesia for transplantation and organ donation activity taking place within NHS GG&C under the clinical supervision (direct or remote) of RMP’s meeting the criteria set out in ANAES1. Specifically this includes anaesthesia for living donation surgery, deceased donation surgical activity, living and deceased donor transplantation in adults and children.
Page 9 of 12

RENAL TRANSPLANT NATIONAL OPERATING PROCEDURE
NOP005 Activities To Be Performed Under The Guidance Of
A Registered Medical Practitioner in Deceased and
Living Donation and Transplantation
Theatre nursing care of the transplant patient or organ donor

NURS1 All Theatre nursing or recipient co-ordinator staff who are registered with the Nursing and Midwifery Council, appointed to NHS GG&C on a locum or substantive basis, subject to NHS
GG&C EKSF policy and regularly perform nursing duties relevant to transplantation and organ donation are assumed to be competent in all roles of the theatre nurse or recipient co-ordinator as applied to transplantation and organ donation activity taking place within NHS GG&C. NHSGG&C annual assessment/EKSF incorporates assessment and documentation of clinical training, practical procedures performed, complaints and continuous professional development. Satisfactory EKSF assessment constitutes a formal demonstration of competency and CPD.

NURS 2 Other Theatre nursing or recipient co-ordinator staff who registered with the
Nursing and Midwifery Council, appointed to NHS GG&C on a locum or substantive basis, subject to
NHS GG&C EKSF policy and who less regularly perform nursing duties relevant to transplantation and organ donation may be certified as competent in all roles of the anaesthetist as applied to transplantation and organ donation activity taking place within NHS GG&C by individuals defined as competent by ANAES1.

NURS 3 A list of staff fulfilling the criteria for NURS1 and NURS2 will be maintained in
NOP005 Supplement 2: Log of Qualified staff for the purposes of organ donation and transplantation activity.
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RENAL TRANSPLANT NATIONAL OPERATING PROCEDURE
NOP005 Activities To Be Performed Under The Guidance Of
A Registered Medical Practitioner in Deceased and
Living Donation and Transplantation
Transplantation Surgery TS1
Name GMC No
Marc Clancy
Enric Murio
4123949
6081340
David Kingsmore 3585009
Vlad Shumeyko
John Asher
Hany Riad
5207432
4615949
2884075
Latest GG&C
Appraisal
2012/13
2012/13
2012/13
2012/13
2012/13
2012/13
Revalidation date Specialist
January 2013
January 2013
2014
2014
January 2013
Register
General surgery
From 29 Oct
2007
General surgery
From 17 Oct
2003
General surgery
From 03 Jun
2005
General surgery
From 20 Jan
2009
General surgery
From 31 Mar
2012
Transplant
Surgery From 10
May 1996
Anaesthesia ANAES1
Name GMC No Appraisal date
Nick Pace
Mark Steven
2592538
3613142
2012/13
2012/13
Revalidation date Specialist
Register
Anaesthetics
From 12 Jun
1996
Anaesthetics
From 31 Jan
2005
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RENAL TRANSPLANT NATIONAL OPERATING PROCEDURE
NOP005 Activities To Be Performed Under The Guidance Of
A Registered Medical Practitioner in Deceased and
Living Donation and Transplantation
NURS 1
Name
Mary McKenzie
Rachel Walker
Jennifer Hall
P Kirkwood
J Gardner
J Binnie
F Carthy
NURS 2
Name
A MacLennan
M McCaskey
F Hill
J Boyd
C Toner
C McWilliams
B Kaur
M Sharp
A McGuire
K Reed
M Gallagher
J Wardhaugh
S Anderson
E Allan
A Craig
A Ford
M Henderson
J McCourt
NMC No
EKSF Signoff
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
EKSF signoff yes yes yes
Yes
Yes
Yes
Yes
Coordinator/Scrub
Certified by/date Signature
20 th June 2013 PK
20 th June 2013
20 th June 2013
PK
PK
20 th June 2013
20 th June 2013
20 th June 2013
20 th June 2013
20 th June 2013
20 th June 2013
20 th June 2013
20 th June 2013
20 th June 2013
20 th June 2013
20 th June 2013
20 th June 2013
20 th June 2013
20 th June 2013
20 th June 2013
PK
PK
PK
PK
PK
PK
PK
PK
PK
PK
PK
PK
PK
PK
PK
Page 12 of 12