THE HEMS PHILOSOPHY
(a) Introduction
This GM outlines the HEMS philosophy. Starting with a description of acceptable risk and introducing a taxonomy used in other industries, it describes how risk has been addressed in this Subpart to provide a system of safety to the appropriate standard. It discusses the difference between HEMS and air ambulance - in regulatory terms. It also discusses the application of operations to public interest sites in the HEMS context.
(b) Acceptable risk
The broad aim of any aviation legislation is to permit the widest spectrum of operations with the minimum risk. In fact it may be worth considering who/what is at risk and who/what is being protected. In this view three groups are being protected:
(1) third parties (including property) - highest protection;
(2) passengers (including patients); and
(3) crew members (including technical crew members) – lowest.
It is for the Legislator to facilitate a method for the assessment of risk - or as it is more commonly known, safety management (refer to Part-ORO).
(c) Risk management
Safety management textbooks83 Reason, J., 1997. Managing the Risks of Organizational Accidents. Ashgate, Farnham. describe four different approaches to the management of risk. All but the first have been used in the production of this section and, if it is considered that the engine failure accountability of performance class 1 equates to zero risk, then all four are used (this of course is not strictly true as there are a number of helicopter parts - such as the tail rotor which, due to a lack of redundancy, cannot satisfy the criteria):
(1) Applying the taxonomy to HEMS gives:
(i) zero risk; no risk of accident with a harmful consequence – performance class 1 (within the qualification stated above) - the HEMS operating base;
(ii) de minimis; minimised to an acceptable safety target - for example the exposure time concept where the target is less than 5 x 10-8 (in the case of elevated final approach and take-off areas (elevated FATOs) at hospitals in a congested hostile environment the risk is contained to the deck edge strike case - and so in effect minimised to an exposure of seconds);
(iii) comparative risk; comparison to other exposure - the carriage of a patient with a spinal injury in an ambulance that is subject to ground effect compared to the risk of a HEMS flight (consequential and comparative risk);
(iv) as low as reasonably practicable; where additional controls are not economically or reasonably practicable - operations at the HEMS operating site (the accident site).
(2) HEMS operations are conducted in accordance with the requirements contained in Annex IV (Part-CAT) and Annex III (Part-ORO), except for the variations contained in SPA.HEMS, for which a specific approval is required. In simple terms there are three areas in HEMS operations where risk, beyond that allowed in Part-CAT and Part-ORO, are identified and related risks accepted:
(i) in the en-route phase, where alleviation is given from height and visibility rules;
(ii) at the accident site, where alleviation is given from the performance and size requirement; and
(iii) at an elevated hospital site in a congested hostile environment, where alleviation is given from the deck edge strike - providing elements of the CAT.POL.H.305 are satisfied.
In mitigation against these additional and considered risks, experience levels are set, specialist training is required (such as instrument training to compensate for the increased risk of inadvertent entry into cloud) and operation with two crew (two pilots, or one pilot and a HEMS technical crew member) is mandated. (HEMS crews and medical passengers are also expected to operate in accordance with good crew resource management (CRM) principles.)
(d) Air ambulance
In regulatory terms, air ambulance is considered to be a normal transport task where the risk is no higher than for operations to the full OPS.CAT and Part-ORO compliance. This is not intended to contradict/complement medical terminology but is simply a statement of policy; none of the risk elements of HEMS should be extant and therefore none of the additional requirements of HEMS need be applied.
To provide a road ambulance analogy:
(1) if called to an emergency: an ambulance would proceed at great speed, sounding its siren and proceeding against traffic lights - thus matching the risk of operation to the risk of a potential death (= HEMS operations);
(2) for a transfer of a patient (or equipment) where life and death (or consequential injury of ground transport) is not an issue: the journey would be conducted without sirens and within normal rules of motoring - once again matching the risk to the task (= air ambulance operations).
The underlying principle is that the aviation risk should be proportionate to the task.
It is for the medical professional to decide between HEMS or air ambulance - not the pilot. For that reason, medical staff who undertake to task medical sorties should be fully aware of the additional risks that are (potentially) present under HEMS operations (and the pre-requisite for the operator to hold a HEMS approval). (For example in some countries, hospitals have principal and alternative sites. The patient may be landed at the safer alternative site (usually in the grounds of the hospital) thus eliminating risk - against the small inconvenience of a short ambulance transfer from the site to the hospital.)
Once the decision between HEMS or air ambulance has been taken by the medical professional, the commander makes an operational judgement over the conduct of the flight.
Simplistically, the above type of air ambulance operations could be conducted by any operator holding an Air Operator Certificate (AOC) (HEMS operators hold an AOC) - and usually are when the carriage of medical supplies (equipment, blood, organs, drugs etc.) is undertaken and when urgency is not an issue.
(e) Operating under a HEMS approval
There are only two possibilities: transportation as passengers or cargo under the full auspices of OPS.CAT and Part-ORO (this does not permit any of the alleviations of SPA.HEMS - landing and take-off performance should be in compliance with the performance Subparts of Part-CAT), or operations under a HEMS approval as contained in this Subpart.
(f) HEMS operational sites
The HEMS philosophy attributes the appropriate levels of risk for each operational site; this is derived from practical considerations and in consideration of the probability of use. The risk is expected to be inversely proportional to the amount of use of the site. The types of site are as follows:
(1) HEMS operating base: from which all operations will start and finish. There is a high probability of a large number of take-offs and landings at this HEMS operating base and for that reason no alleviation from operating procedures or performance rules are contained in this Subpart.
(2) HEMS operating site: because this is the primary pick-up site related to an incident or accident, its use can never be pre-planned and therefore attracts alleviations from operating procedures and performance rules, when appropriate.
(3) The hospital site: is usually at ground level in hospital grounds or, if elevated, on a hospital building. It may have been established during a period when performance criteria were not a consideration. The amount of use of such sites depends on their location and their facilities; normally, it will be greater than that of the HEMS operating site but less than for a HEMS operating base. Such sites attract some alleviation under this Subpart.
(g) Problems with hospital sites
During implementation of the original HEMS rules contained in JAR-OPS 3, it was established that a number of States had encountered problems with the impact of performance rules where helicopters were operated for HEMS. Although States accept that progress should be made towards operations where risks associated with a critical engine failure are eliminated, or limited by the exposure time concept, a number of landing sites exist that do not (or never can) allow operations to performance class 1 or 2 requirements.
These sites are generally found in a congested hostile environment:
(1) in the grounds of hospitals; or
(2) on hospital buildings.
The problem of hospital sites is mainly historical and, whilst the authority could insist that such sites are not used – or used at such a low weight that critical engine failure performance is assured – it would seriously curtail a number of existing operations.
Even though the rule for the use of such sites in hospital grounds for HEMS operations attracts alleviation, it is only partial and will still impact upon present operations.
Because such operations are performed in the public interest, it was felt that the authority should be able to exercise its discretion so as to allow continued use of such sites provided that it is satisfied that an adequate level of safety can be maintained - notwithstanding that the site does not allow operations to performance class 1 or 2 standards. However, it is in the interest of continuing improvements in safety that the alleviation of such operations be constrained to existing sites, and for a limited period.
It is felt that the use of public interest sites should be controlled. This will require that a State directory of sites be kept and approval given only when the operator has an entry in the route manual section of the operations manual.
The directory (and the entry in the operations manual) should contain for each approved site:
(i) the dimensions;
(ii) any non-conformance with ICAO Annex 14;
(iii) the main risks; and
(iv) the contingency plan should an incident occur.
Each entry should also contain a diagram (or annotated photograph) showing the main aspects of the site.
(h) Summary
In summary, the following points are considered to be pertinent to the HEMS philosophy and HEMS regulations:
(1) absolute levels of safety are conditioned by society;
(2) potential risk must only be to a level proportionate to the task;
(3) protection is afforded at levels appropriate to the occupants;
(4) this Subpart addresses a number of risk areas and mitigation is built in;
(5) only HEMS operations are dealt with by this Subpart;
(6) there are three main categories of HEMS sites and each is addressed appropriately; and
(7) State alleviation from the requirement at a hospital site is available but such alleviations should be strictly controlled by a system of registration.
[applicable until 24 May 2024 — ED Decision 2012/019/R]
(a) Introduction
This GM outlines the HEMS philosophy. Starting with a description of acceptable risk and introducing a taxonomy used in other industries, it describes how risk has been addressed in this Subpart to provide a system of safety to the appropriate standard. It discusses the difference between HEMS and air ambulance - in regulatory terms. It also discusses the application of operations to public interest sites in the HEMS context.
Following the extension of the definition of HEMS to rescue operations other than search and rescue (SAR), this GM also discusses rescue operations.
Natural disasters can overwhelm well dimensioned HEMS services at either local or national level. It is up to the State to define how State aircraft or civilian aircraft operated under national rules may complement HEMS services in such [extreme] cases. Operations that take place under national regulations are not discussed in this Regulation.
(b) Acceptable risk
The broad aim of any aviation legislation is to permit the widest spectrum of operations with the minimum risk. In fact it may be worth considering who/what is at risk and who/what is being protected. In this view three groups are being protected:
(1) third parties (including property) - highest protection;
(2) passengers (including patients); and
(3) crew members (including technical crew members) – lowest.
It is for the Legislator to facilitate a method for the assessment of risk - or as it is more commonly known, safety management (refer to Part-ORO).
(c) Risk management
Safety management textbooks84 Reason, J., 1997. Managing the Risks of Organizational Accidents. Ashgate, Farnham. describe four different approaches to the management of risk. All but the first have been used in the production of this section and, if it is considered that the engine failure accountability of performance class 1 equates to zero risk, then all four are used (this of course is not strictly true as there are a number of helicopter parts - such as the tail rotor which, due to a lack of redundancy, cannot satisfy the criteria):
(1) Applying the taxonomy to HEMS gives:
(i) zero risk; no risk of accident with a harmful consequence – performance class 1 (within the qualification stated above) - the HEMS operating base;
(ii) de minimis; minimised to an acceptable safety target - for example the exposure time concept where the target is less than 5 x 10-8 (in the case of elevated final approach and take-off areas (elevated FATOs) at hospitals in a congested hostile environment the risk is contained to the deck edge strike case - and so in effect minimised to an exposure of seconds);
(iii) comparative risk; comparison to other exposure - the carriage of a patient with a spinal injury in an ambulance that is subject to ground effect compared to the risk of a HEMS flight (consequential and comparative risk);
(iv) as low as reasonably practicable; where additional controls are not economically or reasonably practicable - operations at the HEMS operating site (the accident site).
(2) HEMS operations are conducted in accordance with the requirements contained in Annex IV (Part-CAT) and Annex III (Part-ORO), except for the variations contained in SPA.HEMS, for which a specific approval is required. In simple terms there are three areas in HEMS operations where risk, beyond that allowed in Part-CAT and Part-ORO, are identified and related risks accepted:
(i) in the en-route phase, where alleviation is given from height and visibility rules;
(ii) at the accident site, where alleviation is given from the performance and size requirement; and
(iii) at an elevated hospital site in a congested hostile environment, where alleviation is given from the deck edge strike - providing elements of the CAT.POL.H.305 are satisfied.
In mitigation against these additional and considered risks, experience levels are set, specialist training is required (such as instrument training to compensate for the increased risk of inadvertent entry into cloud) and operation with two crew (two pilots, or one pilot and a HEMS technical crew member) is mandated. (HEMS crews and medical passengers are also expected to operate in accordance with good crew resource management (CRM) principles.)
(d) Additional mountain-specific considerations including high altitudes and rescue operations other than search and rescue (SAR)
It was considered necessary to enable sling load operations under HEMS, in addition to the hoist. Environmental, equipment or organisational conditions may lead operators to choose either the external hoist or cargo hook operation, based on a risk assessment.
In order to enable HEMS operations at all altitudes, HEMS operations under performance class 3 have been authorised under the following conditions: operations over a hostile environment should only be conducted when a HEMS operating site used for take-off, landing or HEMS HEC operations is located above 7 000 ft altitude.
The use of category A or equivalent helicopters improves safety during the entire mission, not only in respect of risk of engine failure, but also because of the available system redundancies. Operation in performance class 3 with helicopters not certified as category A or equivalent remains possible under a defined set of conditions and risk mitigations.
(e) Air ambulance
In regulatory terms, air ambulance is considered to be a normal transport task where the risk is no higher than for commercial air transport operations under Part-CAT and Part-ORO. This is not intended to contradict/complement medical terminology but is simply a statement of policy; none of the risk elements of HEMS should be extant and therefore none of the additional requirements of HEMS need to be applied.
To provide a road ambulance analogy:
(1) if called to an emergency: an ambulance would proceed at great speed, sounding its siren and proceeding against traffic lights - thus matching the risk of operation to the risk of a potential death (= HEMS operations);
(2) for a transfer of a patient (or equipment) where life and death (or consequential injury of ground transport) is not an issue: the journey would be conducted without sirens and within normal rules of motoring - once again matching the risk to the task (= air ambulance operations).
The underlying principle is that the aviation risk should be proportionate to the task.
It is for the medical professional to decide between HEMS or air ambulance - not the pilot. For that reason, medical staff who undertake to task medical sorties should be fully aware of the additional risks that are (potentially) present under HEMS operations (and the pre-requisite for the operator to hold a HEMS approval). (For example in some countries, hospitals have principal and alternative sites. The patient may be landed at the safer alternative site (usually in the grounds of the hospital) thus eliminating risk - against the small inconvenience of a short ambulance transfer from the site to the hospital.)
Once the decision between HEMS or air ambulance has been taken by the medical professional, the commander makes an operational judgement over the conduct of the flight.
Simplistically, the above type of air ambulance operations could be conducted by any operator holding an Air Operator Certificate (AOC) (HEMS operators hold an AOC) — and usually are conducted when the carriage of medical supplies (equipment, blood, organs, drugs, etc.) is undertaken and when urgency is not an issue.
Regarding other than SAR rescue operations, if a person without a medical condition is endangered by the environment, then a helicopter may be needed. Such danger may arise, for instance, from temperature, wind, or snow. The same principles as for air ambulance operations should apply when the person’s life is not immediately endangered by the situation, however action is required. In that case, the flight is considered to be a normal transport task where the risk is not higher than for commercial air transport operations under Part-CAT and Part-ORO. None of the additional requirements of HEMS need to be applied. Such a rescue operation may also be conducted by a HEMS operator.
When the medical condition of the person is not known in advance, in a situation of time pressure, then this rescue operation is part of the definition of HEMS.
(f) Operating under a HEMS approval
There are only two possibilities: transportation as passengers or cargo under the full auspices of OPS.CAT and Part-ORO (this does not permit any of the alleviations of SPA.HEMS - landing and take-off performance should be in compliance with the performance Subparts of Part-CAT), or operations under a HEMS approval as contained in this Subpart.
(g) HEMS operational sites
The HEMS philosophy attributes the appropriate levels of risk for each operational site; this is derived from practical considerations and in consideration of the probability of use. The risk is expected to be inversely proportional to the amount of use of the site. The types of site are as follows:
(1) HEMS operating base: from which all operations will start and finish. There is a high probability of a large number of take-offs and landings at this HEMS operating base and for that reason no alleviation from operating procedures or performance rules are contained in this Subpart.
(2) HEMS operating site: because this is the primary pick-up site related to an incident or accident, its use can never be pre-planned and therefore attracts alleviations from operating procedures and performance rules, when appropriate.
(3) Additional HEMS operating site: each HEMS mission is different, especially in mountainous areas where the crew and helicopter need to adapt to different conditions. High altitude, unstable wind conditions, degraded vision, and difficult terrain are some of the characteristics of HEMS operations. Sometimes, the mission requires an additional HEMS operating site to be used, due to performance issues (weight reduction by unloading equipment), for hook preparation and stowage, or for dispatching ground rescue units when the accident or rescue site is not reachable.
(4) The hospital site: is usually at ground level in hospital grounds or, if elevated, on a hospital building. It may have been established during a period when performance criteria were not a consideration. The amount of use of such sites depends on their location and their facilities; normally, it will be greater than that of the HEMS operating site but less than for a HEMS operating base. Such sites attract some alleviation under this Subpart.
(h) Problems with hospital sites are described in GM1 CAT.POL.H.225.
(i) Summary
In summary, the following points are considered to be pertinent to the HEMS philosophy and HEMS regulations:
(1) absolute levels of safety are conditioned by society;
(2) potential risk must only be to a level proportionate to the task;
(3) protection is afforded at levels appropriate to the occupants;
(4) this Subpart addresses a number of risk areas and mitigation is built in;
(5) only HEMS operations are dealt with by this Subpart;
(6) there are three main categories of HEMS sites and each is addressed appropriately; and
(7) State alleviation from the requirement at a hospital site is available but such alleviations should be strictly controlled by a system of registration.
[applicable from 25 May 2024 — ED Decision 2023/007/R]
SPA.HEMS.125 Performance requirements for HEMS operations
(a) Performance class 3 operations shall not be conducted over a hostile environment.
(b) Take-off and landing
(1) Helicopters conducting operations to/from a final approach and take-off area (FATO) at a hospital that is located in a congested hostile environment and that is used as a HEMS operating base shall be operated in accordance with performance class 1.
(2) Helicopters conducting operations to/from a FATO at a hospital that is located in a congested hostile environment and that is not a HEMS operating base shall be operated in accordance with performance class 1, except when the operator holds an approval in accordance with CAT.POL.H.225.
(3) Helicopters conducting operations to/from a HEMS operating site located in a hostile environment shall be operated in accordance with performance class 2 and be exempt from the approval required by CAT.POL.H.305(a), provided compliance is shown with CAT.POL.H.305(b)(2) and (b)(3).
(4) The HEMS operating site shall be big enough to provide adequate clearance from all obstructions. For night operations, the site shall be illuminated to enable the site and any obstructions to be identified.
[applicable until 24 May 2024 — Regulation (EU) No 965/2012]
(a) Performance class 3 operations over a hostile environment shall only be conducted provided one of the following conditions are met:
(1) The HEMS operating site used for take-off, landing or HEMS HEC operations is located above 7000-ft altitude and the helicopter is certified as Category A or equivalent, as determined by the Agency;
(2) The planned HEMS operation does not require the transportation of medical personnel, medical supplies or ill or injured persons, and either the helicopter is certified as Category A or equivalent, as determined by the Agency, or all the following conditions are met:
(i) the helicopter is equipped with crash-resistant fuel systems;
(ii) the helicopter is equipped with a safety belt with upper torso restraint system for use on each passenger seat for each passenger aged 24 months or more;
(iii) the altitude of at least one of the HEMS operating sites used during the HEMS operation is not lower than 3 000 ft;
(iv) the operator has been granted an approval by the competent authority in accordance with point CAT.POL.H.420 of Annex IV;
(3) At least one HEMS operating site used for take-off, landing or HEMS HEC operations during the HEMS operation is located at or above 8 000-ft altitude and all the following conditions are met:
(i) the helicopter is equipped with crash-resistant fuel systems;
(ii) the helicopter is equipped with a safety belt with upper torso restraint system for use on each passenger seat for each passenger aged 24 months or more;
(iii) a helicopter certified as Category A or equivalent, as determined by the Agency, is not available or not suitable for the operation due to either of the following reasons:
(A) insufficient performance margins to operate at the HEMS operating site, or no capability to conduct HEMS HEC operations, if applicable;
(B) helicopters certified as Category A or equivalent, as determined by the Agency, and that might otherwise be dispatched, are on a HEMS mission or not yet ready for the next mission, leading to a delay in the intervention incompatible with the emergency;
(iv) the operator has established a procedure to achieve compliance with point (iii);
(v) the operator has been granted an approval by the competent authority in accordance with point CAT.POL.H.420 of Annex IV;
(vi) the operator shall record all missions flown with a helicopter that is not certified as Category A or equivalent, as determined by the Agency.
(b) By way of derogation from point CAT.POL.H.400(d)(2) of Annex IV, if the criteria of point (a)(1) are met, then helicopter night operations may be conducted in performance class 3.
(c) Take-off and landing
(1) Helicopters that conduct operations to or from a final approach and take-off area (FATO) at a hospital that is located in a congested hostile environment and that is used as a HEMS operating base shall be operated in accordance with performance class 1.
(2) Helicopters that conduct operations to or from a FATO at a hospital that is located in a congested hostile environment and that is not a HEMS operating base shall be operated in accordance with performance class 1 except when the operator holds an approval in accordance with point CAT.POL.H.225.
(3) Helicopters that conduct operations to or from a HEMS operating site located in a hostile environment shall be:
(i) operated in accordance with performance class 2, or if the conditions defined in point (a) are met, in performance class 3;
(ii) exempt from the approval required by point CAT.POL.H.305(a) of Annex IV, provided compliance is shown with point CAT.POL.H.305(b)(2) and (b)(3) of Annex IV.
(4) The HEMS operating site features shall provide adequate clearance from all obstructions, and shall provide for safe operations. For night operations, the helicopter lighting system shall adequately illuminate the landing site and surrounding obstacles.
[for HEMS operations covered by point (61)(a) of Annex I to Regulation (EU) No 965/2012
applicable from 25 May 2024 — Implementing Regulation (EU) 2023/1020
for HEMS operations covered by point (61)(b) of Annex I to Regulation (EU) No 965/2012
applicable from 25 May 2028 — Implementing Regulation (EU) 2023/1020]
PERFORMANCE CLASS 2 OPERATIONS AT A HEMS OPERATING SITE
As the risk profile at a HEMS operating site is already well known, operations without an assured safe forced landing capability do not need a separate approval and the requirements does not call for the additional risk assessment that is specified in CAT.POL.H.305(b)(1).
TAKE-OFF AND LANDING PERFORMANCE — HEMS OPERATING SITES USED FOR TRAINING AND CHECKING
The operator’s risk assessment required under CAT.POL.H.305(b)(1) may take into consideration the following elements pertaining to take-off and landing performance when defining such HEMS operating sites, for the purpose of compliance with SPA.HEMS.125(c)(3)(ii):
(a) altitude;
(b) direction of the approach to the operating site;
(c) prevalent winds;
(d) site weather conditions and operating limitations;
(e) whether there are safe forced landing options, the helicopter has flyaway capability, or none of these;
(f) performance margins regarding hover out of ground effect (HOGE) capability, considering the expected average temperature for exercise;
(g) any defined escape routes during operations;
(h) the maximum number of people on board during manoeuvres in addition to the flight crew and technical crew members.