Department of Health s1

DEPARTMENT OF HEALTH ARSAC Renewal Form DEPARTMENT OF HEALTH (RENEWAL FORM)

APPLICATION FOR RENEWAL OF A CERTIFICATE TO ADMINISTER RADIOACTIVE MEDICINAL PRODUCTS Medicines (Administration of Radioactive Substances) Regulations 1978 (SI 1978 No 1006) Medicines (Radioactive Substances) Order 1978 (SI 1978 No 1004) Medicines (Administration of Radioactive Substances) Amendment Regulations 1995 (SI 1995 No 2147) Medicines (Administration of Radioactive Substances) Amendment Regulations 2006 (SI 2006 No 2806)

Please complete in typescript or black ink and send with original signatures to: ARSAC Support Unit, Centre for Radiation, Chemical and Environmental Hazards Public Health England, Chilton, Didcot, Oxon OX11 0RQ. Telephone: 01235-825006/825007 (administration) 01235-825004/825003 (scientific)

PART A: APPLICANT A

A1 Surname A2 Forenames A3 Post/Position and title A4 Date of Appointment A5 Speciality A6 Address for Correspondence

A7 Telephone Number and Extension A8 Email address A9 Fax Number A10 Name and address of Employer at the site for which the certificate is issued

A11 RPC Number for certificate(s) you / / wish to renew

1 January 2017 DEPARTMENT OF HEALTH ARSAC Renewal Form A12 Has there been any substantial change in your post, speciality or employing authority since the issue of the certificate for which renewal is sought? Yes/No If Yes, PART A of the ARSCAC Full Form must be completed detailing full details of all changes.

2 January 2017 DEPARTMENT OF HEALTH ARSAC Renewal Form PART B: RENEWAL OF CERTIFICATE B

B1 The items included on the existing certificate are listed on the sheet enclosed with this form. Please check the list and cross out any items to be withdrawn, these will not be included on the new certificate.

B2 Maintenance of competence is a Clinical Governance issue and an essential part of modern clinical practice. Certificate holders are expected to be able to show evidence of continuing medical education associated with the nuclear medicine procedures they undertake as part of the appraisal and revalidation processes and if requested to reference this in support of an application for the renewal of their certificate.

I apply for a renewal of my authorisation to administer the radioactive medicinal Yes/No products on the enclosed list.

I confirm that I have undertaken appropriate continuing medical education in Yes/No order to maintain competence in the procedure(s) requested.

I have available to me the supporting services indicated in Part C of the form. Yes/No

I confirm that the information contained in this application is accurate Yes/No

Signature

This signature must be an original Date A1 ☐ Please tick this box if you DO NOT wish to subscribe to our email bulletins 4

3 January 2017 DEPARTMENT OF HEALTH ARSAC Renewal Form

PART C: STAFF, FACILITIES & EQUIPMENT C AVAILABLE TO THE APPLICANT

For the site specified in Part B of this form (the place where diagnosis, treatment or research is to be carried out) please specify:

C1 The name and address of the site:

C2 Equipment Brief details of equipment (e.g. make, model, QA Programme date of installation) Radionuclide dose calibrators Yes/No

Imaging systems Gamma Camera: Yes/No (to include planar, SPECT and SPECT-CT gamma cameras and PET-CT scanners where appropriate)

PET CT Systems:

Sample counters Yes/No (or details of site where counting is performed)

4 January 2017 DEPARTMENT OF HEALTH ARSAC Renewal Form Gamma probes Yes/No (where appropriate)

Other relevant major Yes/No equipment

C3 Facilities Brief details of facility Radionuclide storage

Stock control

Dispensing

Administration of treatment (where appropriate for inpatient or outpatient treatments)

Ward care of patients given treatment (where appropriate)

C4 The Medical Physics Expert should sign below to indicate that the radiation risk estimate associated with this application is accurate, reasonable and can be delivered at the site in question along with the intended clinical outcome. Name

Address and Telephone Number

Signature

Date 5 January 2017 DEPARTMENT OF HEALTH ARSAC Renewal Form C5 The healthcare professional responsible locally for the delivery of unsealed radioactive medicinal products should sign below to indicate that he/she is satisfied with the quality of the radioactive medicinal products. Sealed sources for therapy: the healthcare professional responsible for the receipt and safe storage of sealed sources should sign this section. Name Qualifications Post Relevant experience Signature

Date C6 The scientist or other healthcare professional responsible locally for the scientific support to maintain the equipment and facilities should sign below to indicate that he/she is satisfied with the arrangements for which he/she is responsible. Name Qualifications Post Relevant experience Signature

Date C7 The Radiation Protection Adviser should sign below to acknowledge that they have been informed of this application for this site Name Address

Signature

Date All the above signatures must be originals – photocopies are not acceptable

6 January 2017 DEPARTMENT OF HEALTH ARSAC Renewal Form NOTES ON THE COMPLETION OF THE APPLICATION FORM TO ADMINISTER RADIOACTIVE MEDICINAL PRODUCTS – RENEWAL FORM

Your application for a certificate to administer radioactive medicinal products will be dealt with more quickly if all the information requested is given accurately and completely at the time of application. Some common problem areas which lead to delay are noted below.

i. Applications should be made by those practitioners who have responsibility for the administration of radioactive medicinal products and carrying out procedures, rather than by those requesting them. ii. Before completing this form please read carefully the additional guidance provided in the ARSAC Notes for Guidance (available at www.gov.uk/arsac) iii. Please complete in typescript or black ink and send with original signatures to: ARSAC Support Unit, Centre for Radiation, Chemical and Environmental Hazards Public Health England, Chilton, Didcot, Oxon OX11 0RQ. Telephone: 01235-825006/7 (administration) 01235-825003/4 (scientific) iv. If you wish to add procedures (for diagnosis or treatment) to an existing ARSAC certificate, the additions form should be used v. All signatures must be originals – photocopied signatures are not acceptable

PART C Signatures The persons who sign Part C must be properly qualified and have sufficient experience. Full details of qualifications and relevant experience must be given. Photocopied signatures are not acceptable.

C4 The MPE should sign to indicate that they are satisfied that the radiation risk estimate associated with the application is accurate, reasonable and can be delivered at the site in question along with the intended clinical outcome. The availability and proximity of the MPE should bear a direct relation to the radiation risk involved with the procedures listed in part B of the application. For example, an MPE for a diverse therapy service should be readily available and normally employed at the site listed in the application. An MPE for an application including low dose procedure(s) in a research lab could be offsite and at some distance from the site. The MPE should be satisfied with the local control arrangements for external sites.

C5 Radiopharmaceuticals: There are different models for provision of radiopharmacy services across the UK and different staff groups from a variety of backgrounds may be involved. Para 5 should be signed by a healthcare professional based on site who is locally responsible for the delivery of radioactive medicinal products at the site listed in the application. This person should sign to indicate that they are satisfied with the quality of the radioactive medicinal products in use at the site. There is no need to obtain signatures from external suppliers of radiopharmaceuticals.

C6 The local scientist undertakes to ensure that the site maintains the standard of the listed equipment and facilities to execute the procedures listed in Part B of the application consistent with the risk estimate provided by the MPE. This will include QC, fault finding, ensuring compliance with EA permits etc. In most cases, this person should be 7 January 2017 DEPARTMENT OF HEALTH ARSAC Renewal Form a physicist, particularly in departments providing a wide range of imaging and non- imaging procedures and/or radiotherapy. It is possible that a non-physicist could be responsible for a site where a limited range of low dose procedures are performed.

C7 The RPA should sign to acknowledge that they have been informed of this application for this site. The RPA is responsible for advising the employer on any relevant radiation risks associated with the procedures listed in part B of the application. The RPA does not have to be based at the site listed in the application.

8 January 2017