ENETS-CERT

ENETS-CERT has been commissioned by the European Neuroendocrine Tumor Society ENETS to build up and organize the certification of CoEs – Centers of Excellence.
The content of the certification procedure has been determined in the course of an international interdisciplinary consensus conference.
Compliance with the requirements catalogue is being evaluated in regular audits.
For any further information please contact us via e-mail.

info@enets-cert.com

European Neuroendocrine Tumor Society ENETS
The European Neuroendocrine Tumor Society ENETS, founded in 2004, focuses on the issues mentioned before.
The founding members sought to unify neuroendocrine tumor disease research among European medical professionals. The primary aim was to integrate basic and clinical research with teaching and to establish guidelines for the diagnosis and therapy of gastroenteropancreatic neuroendocrine tumors (GEP NETs). In 2004 and 2005, the „Guidelines for the Diagnosis and Treatment of Neuroendocrine Gastrointestinal Tumours“ were developed and, in April 2005, was published in the journal Neuroendocrinology. Revised Guidelines followed in 2006 and 2007, along with TNM classifications and again 2010 /2012

ENETS‘ goals

  • improving the diagnosis and therapy of patients with neuroendocrine tumors in an international, interdisciplinary and scientific context
  • the coordination of research at European hospitals and health research institutes, with emphasis on basic and clinical research for the diagnosis and treatment of NETs
  • the education and training of physicians and scientists via annual scientific and educational meetings communicating with and informing patients and patient self-help groups
  • the updating of treatment and standards of care guidelines which are to be made public through conferences and the ENETS website
  • establishment of a European database of gastroenteropancreatic neuroendocrine tumors

ENETS centres of Excellence initiative
In 2008 ENETS executive committee started an initiative to implement a voluntary certification procedure to build up and accredit ENETS Centres of Excellence to promote ENETS goals and support its Europe-wide realisation within daily work to assure patient- and quality-focussed diagnostic and therapy of NET-patients.

GSG ENETS-CERT
The ENETS executive committee commissioned GSG Consulting GmbH/ENETS-CERT to handle the certification procedure:

Duties

  • Support in implementation of the certification procedure
  • Support in drafting a requirements catalogue
  • Qualification and support of specialist auditors
  • Maintenance and further development of the certification procedure
  • independent organisation of audits

Centre of Excellence Certification:
What are the benefits?
ENETS with GSG ENETS CERT aim to analyse overall certification benefits prospectively and the process of recertification allows a degree of comparative
Benefits reported by Certified Centers include:

  • Improved recognition (in-house and external)
  • More NET/NEN patients
  • Improved structured cooperation
  • Improved MDT Meetings (more in-depth discussions and consistent specialist participation)
  • Improved patient documentation
  • Improved patient follow-up, quality control and statistics
  • Improved research and more patients in clinical trials
  • Fruitful discussions with external peers during the audit
  • Possibility of recognizing affiliated referral partners

The most important open question at the moment:
Is there a benefit for patients?
It is likely that patients will benefit from implementation of this rigorous process applied to NET healthcare management, as well as the additional education and research. Tangible benefits are difficult to assess, but accumulated data during recertification, coupled with data from the ENETS European Registry should provide important information.

Centre of Excellence Certification
Who can apply?
The applicant has to be an ENETS member and applying Centers should consider whether they fulfil the requirements. The overall accreditation process requires dedication, work and time. Centers should take this into account prior to embarking on this process. Please note the general threshold for application, which is 80 NEW GEP NET patients per year. The application contains information on both quantitative and qualitative issues pertaining to the individual centres and assessment is independent of ENETS, i.e. review is by external auditors).

Center training:
Applying Centers and Centers considering application in the following year(s) are invited to attend a training day to be held in connection with the ENETS Annual Conference March. The CoE training day will be free of charge for two people max/center.

Please note that passing the center training is mandatory for applying centers

Certification Period
A certification period lasts three years, starting at the date of the awarding of the certificate (e.g., awarding date 03.03.2014– elapse date: 03.03.2017) respectively a shortened period, if a major deviation was identified during the onsite audit.

Costs
Applying centers must be willing to sign a contract with GSG ENETS CERT:

Each Center pays GSG a non-recurring fee of 2.500,00 EUR, plus travel costs for the
GSG-auditor.
The certification fee covers for a regular 3-year-period, respectively a shortened period, if a major deviation was identified during the onsite audit.
Each consecutive recertification is billed by GSG ENETS CERT in the same manner.
Currently ENETS supports the procedure by covering the travel costs of the ENETS auditor

Application/Contracting:
Applying Centers are required to submit their application via ENETS on-line application which is available on the member protected part of the ENETS website from March to April.

DEADLINE: 30. April
GSG ENETS CERT will return an acknowledgement of receipt, a certification contract and invoice to the applying Center.
Once GSG has received the signed contract and the certification fee, GSG ENETS CERT
will pre- evaluate the Center’s application.
Then all data is forwarded to the Certification Commission. The Certification Commission decides on enrolment in May. GSG ENETS-CERT informs the Center about the decision.

Kindly note:
In the event of rejection, the certification fee will not be refunded.

DEADLINE: 30. April

Since ENETS is limited to accrediting 15 new centers per year, applications will be handled in the order of their receipt and scoring according to the application form. All consecutive numbers of incoming applications > # 15 will be put on a waiting list.

Those Centers which had to be put on the waiting list will be informed by 31 July whether they can be included in the current procedure.

Centers can reapply to join the accreditation process the subsequent year(s) via the same application procedure.

Audit Organization
Independent auditors
Qualification of ENETS expert auditors

  • Leading function in the health sector
  • Experience and substantial skills in at least one area of NET
  • Experience in research
  • International reputation
  • Personal attributes, including the ability to communicate effectively

ENETS expert auditors will not conduct audits in countries of their own origin.
ENETS expert auditors conduct at least two consecutive audits in one center. (e.g initial audit and one re-certification audit) For the following re-certification audits the expert auditor has to change.

Qualification of GSG ENETS CERT auditors

  • Occupation/ degree in the health sector
  • Qualification as an auditor (e.g. for ISO 9001 or other standards)

Each on-site audit is conducted by two auditors, one (or two) ENETS expert auditors and one GSG ENETS CERT auditor.

Information on Audit Date
Centers receive their audit date in July. In order to keep travel expenses at a minimum by early booking it is necessary that the centers confirm the audit date by 15 August.

Deadlines
The Centers selected for the accreditation process (initial as well as re-certification) are obliged to send in the completed CoE documentation by 15 October, thus allowing auditing to take place between November and February.

Meeting the deadlines is the Center’s responsibility. Missing the deadlines means in effect quitting the procedure. Fees will not be refunded and disbursed travel expenses must be borne by the individual Center.

What has to be sent in?

  • The catalogue, filled in with individual Center information in the right column
  • Contracts as PDFs
  • Certificates of expertise, i.e. PDFs of CV, with the focus on GEP NET
  • (e.g. for pathologists: Senior pathologist (5 years experience) Participation in a course in NET pathology or similar as proof of expertise , proof of Participation in ENETS or similar meetings
  • Task descriptions (data manager / quality manager / head of the center and all others mentioned in the catalogue)
  • Detailed information on patient flow (who sees the patient first)
  • Detailed information about the tumor board
  • SOP as far as available (Octreoscan / PRRT / Pathology reporting etc)
  • Data (Chapter 14 requirements catalogue)
  • Updated anonymized patient list

Audit Plan
The audit plan will be sent to the individual center four weeks prior to the scheduled audit date.

On site Audit (6-7 h for initial certification procedure, 5 h for re-certification procedure)
Each audit is conducted by at least two auditors, one ENETS expert auditor and one GSG auditor.
The audit allows some flexibility and the audit plan, if necessary, will be arranged either in accordance with the Center’s preference or with the auditors once they are on-site.
Standard audit schedule:

  • Opening session (Head of Center/Network and at least one specialist from each core discipline, including data manager and patient coordinator) must be present
  • random sample of ten patient files (selected out of the list of anonymous NEW GEP NET patients)
  • Presentation of the Center (e.g. power point)
  • Structure and management of the Network (Introduction of the specialist team in each discipline, Case flow / work flow: who sees the patient first, who decides about, diagnostics, therapeutics, when and where as well as Follow –up. How is the, F-U- organized, Patient satisfaction and patient involvement, Research projects, Brief information on risk-management / Information on health and safety protection)
  • Multidisciplinary Tumor Board Meeting (Centers /Networks arrange for one of their regular multidisciplinary tumor board meetings)
  • Inspection of the initially selected patient files
  • Visitation of departments
  • The auditors meet NET specialized experts and their staff; they inspect the
  • department location, the designated rooms, the equipment and discuss the SOPs
  • Patient registry and follow- up: The auditors meet the data manager and the center coordinator to discuss technical equipment, the registry organization, procedures of follow-up and outcome measurement.
  • Consideration of the auditors
  • Feedback on major and minor deviations, recommendations and closing meeting

Major and minor deviations
There are definitions of major and minor deviations for initial certification and re- certification.
If there are
≥ 2 major deviations –> no certificate, new initial certification necessary
1 major deviation –> certificate with shortened validity, if declaration of
commitment or proven solution of the identified problem is given within 4 weeks after the audit date. A re-audit is to be run after one year,

All minor deviations –> declaration of commitment and next audit in 3 years,
in the meantime no monitoring by GSG ENETS CERT required.
Identified deviations are object of special attention in the re-certification audit.

Audit Report
The center will receive the audit report within six weeks and has the opportunity to formulate clarifications or an appeal, if necessary.

Decision
In February, the Certification Commission discusses the audit findings and clarifications of the individual centers and gives a recommendation to the ENETS Executive Committee.

If the center cannot accept the decision of the ENETS Certification Commission, the center has to formulate an appeal. This will be finally discussed by the ENETS Certification Commission and the ENETS Executive Board.

The Committee finally decides on the awarding of the certificate. Centers will be informed via e-mail of the final decision by GSG ENETS Cert.

Preparation of Certificates
The individual Center will be asked to send its logo, names and addresses of the Center in order to accurately prepare the Center’s official certificate.

Presentation of the Certificate
The ENETS CoE Certificates will be distributed during the ENETS Annual Conference. If a Center representative cannot be present, the certificates will be sent to the Center by post.

Key figures and Benchmark
Chapter 14 of the requirements catalogue includes the key data each center has to collect.
There will be an online tool starting in 2014 on the member protected part of the ENETS website which has to be filled in annually.
Anonymised results of the benchmark will be published/presented on an ENETS meeting.

Re-Certification
Re-certification is programmed 3 years after initial certification (or earlier see conditions mentioned above) Centers receive a reminder via e-mail in March.
Centers receive an up-date about CoE requirements and procedures per e-mail in March and invoices (re-certification fee) are sent out subsequently.
Centers are obliged to send in the updated CoE documentation by 15 October, thus allowing auditing to take place between November and February.
ENETS expert auditors conduct at least two consecutive audits in one center. (e.g initial audit and one re-certification audit) For the following re-certification audits the expert auditor has to change.

Evaluation of the Certification procedure
In February the audited Centers receive a questionnaire to assess the procedure.
The results are evaluated by the certification commission and lead to further improvement.