Assessment Governance and Integrity

This framework explains how applications are evaluated, how conflicts are managed, how decisions are separated from advisory services, and how applicants can raise an appeal or complaint. It applies to every Centre of Excellence application and designation scope.

Status of the programme

The EUSTM Centre of Excellence is a professional-society quality-recognition programme operated by the European Society for Translational Medicine. It is not:

• A statutory accreditation
• A healthcare licence
• A government approval
• A substitute for national or international accreditation
• A guarantee of clinical or commercial outcomes

EUSTM assesses only the organisation, service and scope identified in the application and assessment agreement.

Governance principles

Every assessment is guided by six principles.

• Evidence. Decisions must be supported by relevant and verifiable evidence.
• Impartiality. Assessors and decision-makers must be free from interests that could improperly influence their judgement.
• Proportionality. Assessment depth and verification methods reflect the size, complexity, services and risks of the applicant.
• Traceability. Findings must be connected to the evidence reviewed and documented in the assessment record.
• Consistency. Comparable requirements and decision principles are applied across applicants within the same assessment scope.
• Continuing standing. An award remains valid only while the organisation continues to satisfy the applicable conditions.

Roles and responsibilities

Programme Secretariat. The Programme Secretariat manages eligibility enquiries, applications, assessment scheduling, document administration, formal communications, maintenance submissions, verification requests and administrative records. The Secretariat does not independently award a designation.

Assessment Team. The Assessment Team examines the application, evidence and verification findings.

Assessors are selected according to the clinical, governance, quality, educational or research expertise needed for the specific scope. A whole-hospital or complex assessment should normally involve more than one assessor.

Decision Panel. The Decision Panel reviews the assessment findings and determines the outcome. Decision-makers must not have provided substantial advisory or preparation services to the applicant during the preceding three years and must disclose any relevant relationship or interest.

Appeal Reviewer or Appeal Panel. An appeal is considered by an individual or panel that did not participate in the original designation decision and has no disqualifying conflict of interest.

Assessment requirements

Before entering a full assessment, the applicant receives or is given access to:

• The applicable assessment scope
• The relevant quality domains
• Mandatory requirements
• Evidence guidance
• Assessment stages
• Expected verification method
• Applicable fees
• Possible outcomes
• Maintenance conditions
• Appeals and complaints information
• Designation and brand-usage requirements

Evidence review

Assessors may consider policies and procedures, governance structures, committee records, clinical audit, quality and safety data, staff training and competency records, patient feedback, regulatory and licensing information, research and ethics documentation, institutional agreements, interviews with leadership and staff, direct observation where applicable, and other evidence relevant to the requested designation.

Written policies alone are not sufficient where implementation is required. Assessors consider whether systems are operating, monitored, understood and improved in practice. EUSTM may request additional evidence where submitted information is incomplete, inconsistent or cannot be verified.

Assessment findings

Each applicable requirement is recorded using the approved assessment framework. Findings distinguish between:

• Verified — the submitted and verified evidence demonstrates that the applicable requirement is implemented.
• Improvement Required — the requirement is partly demonstrated, but additional evidence, clarification or corrective action is required.
• Not Verified — the available evidence does not demonstrate that the applicable requirement is implemented.
• Not Applicable — the requirement does not apply to the approved assessment scope. The reason must be documented.

Mandatory requirements cannot be treated as Not Applicable without a documented scope-based justification. A strong result in one area cannot compensate for failure to meet an applicable mandatory requirement.

Decision outcomes

• Awarded — the applicable mandatory requirements have been verified and the overall evidence supports the requested designation.
• Further Evidence Required — the application is close to meeting the requirements, but specified evidence or corrective action remains outstanding. The applicant receives the outstanding requirements, the evidence or action required, the permitted response period and the method of re-review. No designation is issued until all applicable mandatory requirements are verified.
• Not Yet Ready — the evidence does not currently support the requested designation. The applicant receives a written explanation and may submit a future application following an appropriate development period.

Impartiality and conflicts of interest

Before participating, assessors and decision-makers must declare interests that may affect — or reasonably appear to affect — their impartiality.

Relevant interests may include current or recent employment, consultancy or advisory relationships, financial relationships, research collaboration, close professional relationships, competitive interests, personal relationships, and other circumstances capable of influencing judgement.

Where a material conflict exists, the individual is recused and replaced. An individual who has provided substantial advisory or preparation services to an applicant must not assess, decide or hear an appeal concerning that applicant for three years after that engagement.

Separation of advisory and assessment services

EUSTM advisory services are optional and separate from the Centre of Excellence decision. The following safeguards apply:

• Purchasing advisory services is never a condition of applying.
• Advisory personnel do not guarantee assessment outcomes.
• Advisory records and assessment records are maintained separately.
• The applicant is not advantaged or disadvantaged because it did or did not purchase advisory support.
• Individuals involved in preparation are excluded from the assessment and decision in accordance with the conflict-of-interest requirements.
• Membership in any EUSTM programme does not influence the designation decision.

Assessment fees

Fees pay for eligibility and scope administration, assessor preparation, evidence review, verification activity, assessment reporting, decision administration, and programme records and designation administration.

Appeals

An applicant may appeal within 30 calendar days of receiving the formal assessment decision. An appeal may be based on:

• A material failure to follow the applicable assessment procedure
• Evidence submitted within the permitted period not being considered adequately
• A material factual error in the assessment record
• An undisclosed conflict of interest affecting the assessment or decision

Disagreement with professional judgement alone is not sufficient unless connected to one of the permitted grounds.

The appeal is reviewed by an individual or panel that had no role in the original decision, has no material conflict of interest, and has access to the relevant application and assessment record.

EUSTM acknowledges an appeal promptly and provides the appeal outcome, with reasons, in writing. An upheld appeal results in reconsideration of the affected part of the assessment; it does not automatically result in an award.

Complaints

A complaint may concern assessor conduct, administrative handling, confidentiality, conflict-of-interest management, communication, use of information, or other aspects of programme administration. Complaints about the technical assessment outcome are handled through the appeals process.

EUSTM should acknowledge a complaint within five business days and normally provide a written response within 30 business days.

Where more time is required, the complainant is informed of the reason and expected response date. No applicant is disadvantaged for submitting a good-faith complaint or appeal.

Annual maintenance

During the three-year designation period, the designated organisation must provide the required annual maintenance confirmation.

This may include confirmation of continued licensing and regulatory standing, significant organisational changes, updated quality or safety information, progress on agreed improvement actions, confirmation of continued activity, appropriate use of the designation, and any evidence specifically required in the award letter.

Failure to provide maintenance information may result in suspension.

Material changes and reporting

The organisation must inform EUSTM of material changes relevant to the designation.

These may include a change of ownership or legal entity, change of location, significant change in clinical scope, loss, restriction or suspension of a relevant licence, serious regulatory action, closure or restructuring of the assessed service, material patient-safety concerns, misleading use of the designation, or information demonstrating that the original basis of the award may no longer apply.

Notification should be made without unreasonable delay. EUSTM may request additional evidence or conduct a focused review.

Suspension, withdrawal and expiry

A designation may be suspended or withdrawn where:

• Mandatory requirements are no longer satisfied
• The organisation provides materially false or misleading information
• A relevant licence is suspended or withdrawn
• Serious regulatory or patient-safety concerns remain unresolved
• Annual maintenance requirements are not completed
• The designation or mark is used misleadingly
• The organisation refuses reasonable verification
• Required corrective action is not completed
• Fees properly due under the assessment agreement remain unpaid
• Continued recognition would materially undermine the integrity of the programme

Before withdrawal, the organisation is normally informed of the concern and given an opportunity to respond, except where immediate action is reasonably required to protect patients, the public or programme integrity.

An expired, suspended or withdrawn designation must no longer be displayed as current.

Verification

EUSTM can confirm the designated organisation, the approved designation title, the assessed scope, the award date, the expiry date, and whether the designation is current, suspended, withdrawn or expired.

Verification does not disclose confidential assessment evidence. EUSTM should maintain a reliable verification route so patients, institutions, partners and other stakeholders can confirm the standing of a designation.

Confidentiality and data protection

Assessment information is used only for eligibility review, assessment, decision-making, quality assurance, maintenance, appeals and complaints, programme verification, and legal and regulatory obligations.

Access is limited to authorised personnel and contracted experts with relevant responsibilities.

Applicants should not submit patient-identifiable information unless expressly required through an approved secure process. Where examples are necessary, information should be anonymised or appropriately redacted.

Personal and institutional data are processed in accordance with EUSTM’s Privacy & Cookies Policy and applicable data-protection requirements.

Programme quality assurance

EUSTM periodically reviews assessment consistency, assessor performance, appeals and complaints, conflict-of-interest declarations, applicant feedback, verification processes, use of the designation, programme risks, and opportunities for improvement.

Changes to requirements are version-controlled and communicated appropriately.

Questions, appeals, complaints and verification

Contact EUSTM if you wish to ask a question about assessment governance, confirm which assessment framework applies, submit an appeal, raise a complaint, report potentially misleading use of a designation, or verify whether a designation is current.