ARA.MED.120 Medical assessors

EXPERIENCE AND KNOWLEDGE Medical assessors should:

(a)have considerable experience of aero-medical practice, having held AME privileges and having undertaken a minimum of 200 class 1 or class 3 medical examinations or equivalent;

(b)undergo specific training on the regulatory processes and aero-medical certification of referred cases; and

(c)maintain their medical professional competence in aviation medicine. The following should count towards maintaining medical professional competence:

(1)undertaking regular refresher training;

(2)participating in international aviation medicine conferences;

(3)undertaking research activities, including publication of results of the research.

TASKS Medical assessors’ tasks include:

(a)approving and overseeing lectures in basic, advanced and refresher training courses for aero-medical examiners (AMEs) and aero-medical centres (AeMCs). Medical assessors may also deliver lectures during those training courses provided that a procedure is in place to avoid conflict of interest;

(b)carrying out supervision and audits of AeMCs, AMEs and AME training facilities;

(c)performing the aero-medical assessment of applicants for, or holders of, medical certificates in the case of consultation, referral or secondary review, or when medical certificates have been issued by non-compliant AMEs;

(d)certifying and overseeing AeMCs and AMEs, including review of medical files submitted by them to the competent authority;

(e)managing medical files including transfers of medical files in the case of a change of state of licence issue;

(f)assisting AMEs and AeMCs, on their request, regarding aero-medical fitness assessments in borderline and difficult cases or cases not regulated in Part-MED or Part-ATCO.MED of Regulation (EU) 2015/340, as applicable; and

(g)issuing a medical certificate if a case is referred or if corrections to the information of a medical certificate are necessary.

DELEGATION OF MEDICAL ASSESSOR TASKS The medical assessor may delegate certain tasks to other staff designated by the competent authority or other persons contracted by the competent authority. The competent authority should ensure that such person has relevant training and experience for the delegated task and that the entire process is properly documented.

DELEGATION OF MEDICAL ASSESSOR TASKS Properly qualified medical assessors are essential for maintaining flight safety and an efficient and functional aero-medical system. Medical assessors, like any inspector of the competent authority, should, by their qualifications and competencies, command the professional respect of the personnel and organisations they inspect, authorise or oversee. These guidelines aim to establish possible solutions to optimise the use of qualified medical assessors as well as temporary solutions until properly qualified medical assessors are readily available. These guidelines should be interpreted and implemented only to the extent that they provide for sound and effective oversight in accordance with the principles of safety risk management. For all of the medical assessor tasks, the support staff may provide administrative support with regard to the paperwork and preparation work. Furthermore, some tasks may be partially delegated to other staff members of the competent authority or other persons contracted by the competent authority. The medical assessor should select to whom the tasks are delegated based on their qualifications in order to ensure that the entire performance is in line with the applicable provision both in the field of aviation and in the medical field and is properly documented. The compliance monitoring system of the competent authority should ensure that delegation of certain tasks has no negative impact on flight safety and data protection. In order to maintain their medical proficiency, medical assessors may act as an AME subject to a proper procedure being in place to avoid conflict of interest. The following steps may be considered when required:

(a)Employment of a not fully qualified medical assessor When recruiting a fully qualified medical assessor is not possible, the competent authority may employ a medical doctor to be trained and nominated as a medical assessor once the training is finalised. The performance of these doctors should be supervised by a qualified medical assessor from the pool of experts.

(b)Assignment of the role of a team member to qualified inspectors (e.g. assessing the SMS system of an AeMC) In this context, the qualified inspectors performing duties within the inspection/oversight team are expected to document their work and to report to the medical assessor as the accountable person for the process.

(c)Use of appropriately qualified medical assessors or AMEs from a pool of experts The use of AMEs or medical assessors from a pool of experts should be limited to the sharing of experts to cover unplanned activity or temporary/transitional shortage of expertise rather than a consistent long-term use. The following types of pools of experts may be considered: qualified AMEs; medical assessors from the NCAs of other Member States or from EASA; medical assessors/AMEs from military aviation. The following issues should be assessed and the associated risks mitigated in the case of using a pool of experts: assessment and oversight of the expert’s performance as well as enforcement in case of non-compliance; authorisation of the expert to access medical practices, investigate, conduct interviews and collect evidence; financial, contracting and administrative aspects; recurrent training on administrative procedures; ability of the nominated expert to write reports and findings; avoidance of conflict of interest; sustainability (i.e. to avoid relying permanently on the pool of experts); commercial sensitivity of AMEs/AeMCs, cultural issues; data protection issues; language barriers; recognition between Member States, including the right to practice medicine in a different State and medical indemnity/liability insurance. Bilateral sharing of experts is convenient when: the requesting authority is aware of the resources available in the resource provider; the agreement between the NCAs exists or is easy to establish; the planning for the availability of the resources can easily be managed. Whether the sharing of medical assessors is concluded directly between two NCAs or through a sharing platform, sustainability can only be ensured if all stakeholders are willing to consider global optimisation as a priority. The challenge is that the management system of each NCA may systematically reduce its resources so that all qualified medical assessors are occupied at all times. Such planning strategy does not provide any extra margin for contingencies and may easily drift towards understaffing. It is always difficult to swiftly adjust the number of permanently employed experts to the short-term oversight needs. Therefore, while attempting to ‘optimise’ its own resources, each NCA may rely more and more on the experts from other NCAs and further reduce its staff. While this may work for a limited period of time, in the long run the sharing of experts may simply become impossible as all NCAs will be requesting qualified medical assessors while no NCA would be able to provide any. A similar reasoning applies when experts from the industry are shared. The concept of sharing implies availability of resources. Availability means extra capacity. Therefore all stakeholders involved in the sharing are expected to coordinate their staffing strategies globally. This ensures global optimisation by reallocating resources so that no expert is underused and that the costs are shared based on the level of support obtained. Additionally, it is expected that activity planning is coordinated among all involved stakeholders.