1. RADIATION SOURCE REGISTERS IN PORTUGAL
INTERNATIONAL WORKSHOP ON NATIONAL registers OF RADIATION SOURCES
CONTRIBUTORS
Pedro Horta Rosário
Environmental and Occupational Health Division
Directorate-General of Health (DGS)
A. Baptista
Instituto Superior Técnico (IST/CTN)
University of Lisbon
A. S. Fonseca
Regulatory Commission for the Safety of Nuclear Installations (COMRSIN)

2. SUMMARY Regulatory framework Registers: at DGS at IST/CTN at COMRSIN
Overview of data from all three registries
Challenges
Conclusions

3. regulatory framework Medical practices DGS Industrial practices DRE
AUTHORIZATION
INSPECTION
Medical practices
DGS
ARS e autoridades de saúde
Industrial practices
DRE
Portugal does not have a single regulatory authority. However, regulatory duties are assigned to different institutions that, together, constitute the regulatry body.
Research and teaching
IST/CTN
Nuclear installations
COMRSIN
COMRSIN
Spent Fuel and Radioactive Waste
Sealed Radioactive Sources
IST/CTN
IST/CTN

4. regulatory framework Directive 96/29/EURATOM Directive 97/43/EURATOM
Decree-Law 165/2002 (regulatory system)
Decree-Law 180/2002 (medical practices)
Decree-Law 38/2007 (sealed sources)
Decree-Law 156/2013 (radioactive waste management)

5. Authorization process
regulatory framework
Authorization process
For all radiation sources
For sealed sources
For radioactive waste
Import
Holding
Transport
Transfer
Management
Disposal
Clearance
This diagram presents na overview of the existing authorization processes.
First of all, in order to use any radiation source, including radiation generators, this practice must be authorized by DGS.
Import authorizations for radiation generators or unsealed sources are also required and handled by DGS.
If the practice involves sealed sources, then each of them needs its own authorization, that is handled by IST. These authorizations are required for import, holding, transport and transfer of sealed sources, and apply to all sources with activity above exemption level.
More recently, new regulation was passed concerning radioactive waste. This requires an authorization to perform waste management operations and to send radioactive waste to disposal.
Use
Import
Export
DGS
IST/CTN
COMRSIN

6. register at dgs
Register of authorizations for use of (all) radiation sources.
All information was originally stored (and counted!) on paper.
First digital index of authorizations was created in 2005, in use ever since.

7. register at dgs RAIS3.0 was used in tandem from 2007 to 2012.
IAEA support in migrating database from Excel through an expert mission.
Migration was done in less than a week.
Later limitations with Windows7/Office updates and restricted output possibilities (issuing licenses) prevented further use.

8. register at dgs Based on MS-Excel. 3 main tables: Applicants
Authorizations
“Administrative history”
VBA code to issue licenses and other documents.
Adapted to the administrative processes through templates.
Still keeps the data structure from previous migration to RAIS (generator number, asso numbers, etc.)
Easily maintained and upgraded with new features.
Not very robust, limited connectivity, few simultaneous accesses.

9. register at dgs Entities Authorizations History
Process number (Primary key)
License number, year, issue date
Type of practice
Type of radiation generator, manufacturer, model, generator ID
RPO name, Medical Physicist, IDnumbers
Workload for x-ray generators
Sealed sources included in the practice
Un-sealed sources included in practice
Process number (primary key)
Name
Address, Zip code, City
Contacts
VAT Number
History
Process number (Primary key)
Name
Action date
Action type
Input Number
Output Number

10. register at dgs
When a authorization is issued, all the data on it are automatically stored on the database.
Issuing the authorization adds the radiation source to the inventory list.

11. register at dgs VBA Multiple templates (…)
We currently use this system to generate all relevant documents through templates.
This applies to licenses, checklists for evaluating applications and other correspondence with applicants.
Multiple templates
(…)

12. register at dgs
Identification of sealed sources provides a link between the registries at DGS and at IST/CTN.
This is what our current authorizations look like.
Each authorization has its own individual number.
For radiation generator, the maxmimum allowed workload is also specified.
If the practice uses unsealed sources, maximum allowed activity is specified, which then relates to authorized discharge limits.
If sealed sources are included in the practice, the authorization identifies them specifically, by isotope and maximum activity allowed.
The associated equipament is also specified.

13. register at ist/CTN
This brings us to authorizations for sealed sources, which can be seen here.
Each authorization for sealed source, issued by IST is specifically linked to the authorization for the practice issued by DGS.
You can see examples for holding and transport authorizations here
Source: IST/CTN

14. register at ist/CTN IST uses a custom-made solution.
Based on MS Access.
Separate tables for registry of Entities, Sources, Authorizations,…
Traces EURATOM documents.
Source: IST/CTN

15. Register at ist/ctn
Authorizations issued by IST/CTN (import, holding, transport, transfer) always include a reference to the authorization of use issued by DGS.
Multiple authorizations are traceable to each source and holder.
This image is a screenshot from the system used by IST. It shows, for a particular Entity, each source that it holds and which authorization for practice it has.
If the applicant doesnt have an authorization to carry out the practice issued by DGS, they cannot apply to import or to hold sealed sources.
Source: IST/CTN

16. register at COMRSIN Dedicated platform for tracking radioactive waste.
Allows external user-logins and viewing of application status.
Streamlined to the administrative process, allows issuing of all relevant documents.
Tables for:
Entities
Transporters of radioactive waste
Authorizations for waste management activities
Disposal authorizations
The latest addition is an accounting system for radioactive waste.
This was developed by COMRSIN, as an online platform where waste producers can log on and report or apply for disposal or waste management operations.
Rest of the slide.

17. register at comrsin
Like before, both the system and the authorizations issued by COMRSIN are always referencing the authorization for practice issued by DGS.
Source: COMRSIN

18. register at COMRSIN
This system is built-in with some reports and is still being adjusted.
Source: COMRSIN

19. New law for Dental Offices
overview of data
Additional HR
New law for Dental Offices

20. overview of data
Source: DGS

21. Authorizations for practice issued per year, per type
overview of data
Authorizations for practice issued per year, per type
(includes renewals)
2012
2013
2014
2015
2016
2017*
TOTAL
(IO+Ceph+CBCT)
2418
1237
904
1489
512
262
6822
Diagnostic and Interventional Radiology
321
376
383
479
170
108
1837
Nuclear Medicine 7 8 4 11 2 36
External Beam Radiotherapy 15 10 3 14 9 53
Brachytherapy (LDR+HDR+PDR) 5 20 13 61
Veterinary radiology 86 82 58
158 30
475
Industrial Radiology
319
171
151
281
189 72
1183
Research and teaching 19 52
3196
1897
1516
2461
969
480
10519
Source: DGS

22. overview of data
Source: DGS

23. Top 5 most common manufacturers
overview of data
Top 5 most common manufacturers
Dental radiology
Industrial radiology
External Beam Radiotherapy
TROPHY
TROXLER
VARIAN
KODAK
HEIMANN
ELEKTA
GENDEX
SMITHS
SIEMENS
SATELEC
ENDRESS HAUSER
ACCURAY
VILLA
BERTHOLD
LEKSELL
Source: DGS

24. overview of data
Source: IST/CTN

25. Radioactive Waste Disposal requests in 2016
Overview of data
Radioactive Waste Disposal requests in 2016
Source: COMRSIN

26. Overview of data
Source: COMRSIN

27. Data sharing List of authorized users available on the DGS website.
Sectoral information shared yearly with Inspection authorities.
Information regarding sealed sources (picture) shared with Civil Protection, for EP&R purposes.
Source: DGS

28. challenges Few resources available. Lack of dedicated IT-support.
How to handle bankrupcy situations (and associated authorizations)?
Keeping track of all Annual Source Declarations (IST) and Annual Reports (DGS).
Connectivity between existing registers is not automatic.
Keeping track of un-sealed sources.

29. challenges
Unsealed sources?

30. Conclusions
The regulatory system in Portugal is distributed through several institutions.
Dedicated registers exist that keep track of radiation sources.
Registers are custom-made solutions by each institution.
Although its not automatic, multiple cross-checks are in place between systems.

31. Thank you! prosario@dgs.pt Pedro Rosário
Special thanks to Mr. A. Baptista (IST/CTN) and Mr. A. S. Fonseca (COMRSIN)