Information meeting for KPM users
7-8th October 2015
Ingfrid Slaatto Næss Head of Section, Comparative Medicine Mikael Vestberg
Agenda
1. New Legislation/Provision (Ingfrid) 2. New Routines (Ingfrid)
• a. SOPs available at the homepage (sugggestion for changes can be done until late December)
• b. Biopsies- SOP 7-004 routine for biopsies
• c. Signature for read SOPs and New Legislation before access, 15 November
• d. Routines for Import – approved suppliers, health status accepted, rotation in the departement, delivering of animals (Mikael)
3. Allocation of cages/capasity (Jan)
4. Project going concerning organizational changes (Jan) 5. Moving into MDU (Ingfrid)
6. Labtracks (Mikael) 7. Homepages (Ingfrid)
New Provision and New Legislation
• New provisions to the animal welfare act effective since 1/7-2015 (based on EU-directive 2010-63- EU)
• New provisions will have little impact on the daily performance of animal experiments
• Ethical applications (FOTS-projects) will now be processed by Mattilsynet, not by “lokal ansvarshavende”
• The animal facility is required to have internal control systems and named persons with responsibilities as defined by the provision
• A fee for processing ethical applications is expected to be implemented by end of 2015
• To accommodate new requirements in the provisions, some updates are expected, but FOTS remains largely unchanged as the electronic portal and document format for submitting ethical applications
• Local input from ”person with special responsibility for animal welfare” is still required
• Forsøksansvarlig (applicant)*
• Leder med ansvar for etterfølgelse av forskriften
• Person med særskilt kontrollansvar (PMSK)
• Navngitt veterinær*
• Dyrevelferdsenhet
What’s new?
Responsibilities
• Mattilsynet (MT) is obliged to respond within 40 workingdays from receiving a complete application (practise before = variable processing time)
• Prospective severity category, non-recovery, mild, moderate and severe (practise before = subjective severity scoring)
• Retrospective assessment by performed studies by MT. Users have to submit documentation (practise before = no assessment of performed studies)
• Project summary is required by submission in FOTS
What’s new?
Applications
What’s new?
Implications
• Introduction of a needle in accordance with good veterinary practise and all other procedures causing similar or more stress or harm = procedures require application (practise before = bloodsampling and secretions by simple
techniques and ID-marking = application not required)
• The provision cover breeding of animals with the intent to harvest organs for scientific use
• Killing animals by approved methods with the intent to harvest organs = excempt application (practise before = killing animals with the intent to harvest organs = excempt application)
• Defined list of approved methods for killing animals
Internal Quality Control System KPM
Responsibilities
• KPM head of section: (Ingfrid)
– Leder med ansvar for etterlevelse av forskriften – Person med særskilt kontrollansvar (PMSK) – Navngitt veterinær
– Medlem av dyrevelferdenheten
Internal Quality Control systems KPM
PMSK
– More or less the same responsibilities as «lokal ansvarshavende» had before 1. of July
– Responsibilities:
• Overseing the welfare and care of animals
• Ensure that staff and users are adequately educated, competent and continuously trained
• Registration of all users in FOTS
• Local review of changes-notification of or application for change?
Internal Quality Control systems KPM
Dyrevelferdsenhet
– Responsibilities:
– Advice user/staff on:
• Animal welfare in relation to acquisition, housing and use
• Application and scientific/technical development of 3Rs
• Follow the development and outcome of studies with respect to effects on animal welfare
• Establish and review internal procedures for monitoring, reporting and follow-up on animal welfare
• Meetings at least once a year
• Members: 1 user, 1 employe KPM, PMSK
Internal Quality Control Systems
Applicant responsibilities
– All ethical applications, including changes, must be submitted via FOTS and contain the elements described in §§7-18 – All participants must be qualified and included in the FOTS ID – Study performance in accordance with study authorisation – Unnecessary pain, suffering, distress or lasting harm must be
stopped
– Non compliance with study authorisation must be corrected – Non compliance and corrective measures must be recorded – Schedule project meeting with KPM staff if requested to do so – Submit numbers on annual use of research animals, conf § 36 – Failure to submit annual animal use numbers represents
noncompliance
FOTS application process, 1
• A project summary and severity category classification is required in a FOTS id from 1 July 2015
• A guidance document on how to make good ethical applications in FOTS has been distributed by e-mail 1 September 2015
FOTS application process, 2
• The application will be reviewed locally, using a standardised form
– Is the project technically possible to perform?
– Is formal information missing?
– Is specific information missing (e.g is the technical performance, adverse clinical effects and action plan written clearly and complementary, enabling
objective evaluation of study compliance)?
• Upon completion, the local review will be uploaded to the FOTS id in question
FOTS application process, 3
• Local reviews will be completed within 14 days
• It is the applicants decision to respond to the local review in a manner that he/she finds appropriate, before
submitting the final version of the FOTS id to Mattilsynet
• KPM will not review a FOTS id twice, unless specifially asked to do so by the applicant
• If requested, repeated local reviews of a FOTS id will be performed as soon as possible, dependant upon resource availability
FOTS application process, 4
• Changing a previously approved project requires either notification of, or application for, minor change
• Notification of minor changes is relevant if the required changes are considered to have «no negative impact on animal welfare»
• Applying for minor changes must be used if the required changes are considered to have negative impact on animal welfare
• PMSK will review and decide on the need for notification or application
FOTS application process, 5
• Documentation of training and education, including continuing education, is required
• All users that attend lab animal courses before 1. July 2015 must submit a signed declaration that they have read the new provisions to the animal welfare act. An electronic PDF-copy of the signed document must be submitted to KPM before 15. November 2015
Fees for FOTS submission
• Mattilsynet has suggested the following fees for processing ethical applications for experimental animal studies
• Fees will most likely be effective from late 2015
• The fees are maximum figures, lower fees and less time likely will apply if the application is complementary and well written
Type of study
Fee category Maximum fee (kr)
Pilot study D 3605,-
Main study C 5765,-
Minor change B 1440,-
• Contact KPM to make sure there is space for new cages
• Write FOTS.
• Furnish KPM with contact details to ”export officer” at sending institution.
• (KPM will collect data on health status and routines)
• Contact NTS early on to schedule rederivation of mice
• KPM will rederive rat strains
Importing animals
from collaborators and
repositories
• After exiting the changing room walk to your right as indicated on the wall
• After finishing work, exit through airshower and over disinfection mats.
• When bringing cages out of MDU bring the first with you to the glass door
• A single cage can be placed in the reach through box for a couple of minutes.
• When leaving with several cages, place them on shelves by the glass door.
• Request staff to help you transfer cages to your own trolley waiting in
Rotation in the MDU
Bringing animals out of MDU
Prosjekt for videreutvikling av
Avdeling for komparativ medisin
Bakgrunn
• Avdeling for komparativ medisin har i flere år vært i en krevende omstillingsprosess. Prosessen pågår fremdeles.
• Utfordringene er kartlagt. Brukerforum har bidratt til å konkretisere og tydeliggjøre problemene.
• Instituttet etablerer et organisasjonsutviklingsprosjekt for å sikre at problemene blir løst og at avdelingens muligheter blir utnyttet.
• Prosjektets mandat:
– sikre at arenaer for brukermedvirkning fungerer
– gjennomgang og vurdering av tjenestetilbud, servicenivå og rutiner; iverksette tiltak
– forbedret styring og kontroll innen økonomi, innkjøp og HR; iverksette tiltak
• Sikre at avdelingen har de nødvendige rammebetingelser, strukturer og styringsverktøy for økonomisk bærekraft, effektiv ressursbruk og god kompetanseutnyttelse
• Sikre kostnadseffektiv drift innenfor gjeldende regelverk og rammebetingelser
• Legge til rette for at tjenestetilbudet, forutsigbarheten og servicenivået overfor brukere er tilfredsstillende innenfor tilgjengelige rammer
• Bidra til økt brukertilfredshet og styrket omdømme
Ønskede effekter av prosjektet
Styringsgruppe: Instituttets ledergruppe
Prosjekteier: Avdelingsleder Ingfrid S. Næss Prosjektleder: Adm. nestleder Linda Helgesen
Prosjektgruppe/arbeidsgrupper:
– Økonomi og innkjøp
– Bemanning og kompetanse
– Tjenestetilbud og brukerinvolvering
Referansegruppe:
Representanter fra fagmiljøene og dyrestallsfaglig kompetanse
Organisering, roller og ansvar
• Average over a month
LABTRACKS
Cage counts
• Per diem cost, automatic calculation
•
LABTRACKS
Cage counts- scanning
• Empty cages removed weekly (currently no charge)
LABTRACKS
Cage counts- scanning result
• Sort your Cages List on Rack #
LABTRACKS
Cage counts- scanning result
• KPM will provide ear (/toe) biopsies from weaners without a task
• Start with one group at a time
• Users organise in one breeding group and one experimental group
• Users set up task for breeding such that staff have enough information
• Users set up a task for new back up animals and new breeders
• Users change group for animals to be used in experiments
• Users register animals for experiments with FOTS or Invitro project nr
Improved service
Added responsibilities
• Register animals used in experiments with protocol#
• In vitro projects (A followed by serial nr, e.g. A001- A012)
• Given for five years or until regulations changes
• No limit of animals used
• FOTS projects
• KPM copies approved application from FOTS database
• Users presents relevant data to staff at KPM
• Users register animals used in experiments with relevant FOTS nr
• A report can be generated to help users with yearly use reports
Improved service
Added functionalities
Improved service
Added functionalities
• Animal disposition
Improved service
Added functionalities
LABTRACKS
Follow up
Training
•New users get the basics in about an hour. Contact Mikael
•When Mikael visits Oslo there will be opportunities to discuss around certain topics in colony management and time for general or more specific questions.
