Appendix A FIGURE A-1. SAMPLE SEVERITY AND LIKELIHOOD CRITERIA Severity of Consequences Likelihood of Occurrence Severity Level Definition Value Likelihood Level Definition Value Catastrophic Equipment destroyed, multiple deaths 5 Frequent Likely to occur many times 5 Hazardous Large reduction in safety margins, physical distress or a workload such that operators cannot be relied upon to perform their tasks accurately or completely. Serious injury or death. Major equipment damage.
4 Occasional Likely to occur sometimes 4 Major Significant reduction in safety margins, reduction in the ability of operators to cope with adverse operating conditions as a result of an increase in workload, or as result of conditions impairing their efficiency. Serious incident. Injury to persons.
3 Remote Unlikely, but possible to occur 3 Minor Nuisance. Operating limitations. Use of emergency procedures.
Minor incident.
2 Improbable Very unlikely to occur 2 Negligible Little consequence 1 Extremely Improbable Almost inconceivable that the event will occur 1
Appendix A A-3. RISK ACCEPTANCE.
a. Risk Acceptance. In the development of risk analysis criteria, HAA operators are expected to develop risk acceptance procedures, including: acceptance criteria and designation of authority/responsibility for decisionmaking.
b. Acceptability of Risk. The acceptability of risk can be evaluated using a risk matrix such as those illustrated in Figure A-2. Figure A-3 shows areas with an alphanumeric scale and is an example of how risk matrices may be color-coded: unacceptable (red), acceptable with mitigation (yellow) and acceptable (green).
(1) Unacceptable (Red). Where combinations of severity and likelihood cause risk to fall into the red area, the risk would be assessed as unacceptable. A flight should not be authorized under unacceptable conditions until further controls are developed which eliminate the associated hazard or which would control the factors that lead to higher risk likelihood or severity.
(2) Acceptable with Mitigation (Yellow). When the risk analysis falls into the yellow area, risk may be accepted under defined conditions. Risk mitigation may also include consideration of alternate routes/destinations. A decision to initiate an operation should be elevated to a person responsible for Operational Control decisionmaking prior to conducting the flight. For example, landings and takeoffs at high altitude or high density altitude Landing Zones (LZ) present risks resulting from marginal aircraft performance. Risk mitigation could include load reduction or selecting a LZ at a lower altitude where aircraft performance would not be affected as significantly.
(3) Acceptable (Green). Where the assessed risk falls into the green area, it may be accepted without further action and the flight dispatched. The objective should always be to reduce risk to as low as practicable regardless of whether or not the analysis shows that it can be initially accepted.
A-4. SAFETY RISK MATRIX EXAMPLES. The operator should have written policies that define (in numerical terms) acceptable levels of risk, procedures for determining risk acceptability and steps to be taken for a given level of assessed risk, including risk control strategies. § 135.617 requires HAA operators have a documented procedure for elevating the management level required for flight approval when risk exceeds predetermined levels.
Appendix A FIGURE A-2. SAMPLE "STOP LIGHT" DECISIONMAKING MATRIX Severity Higher Likelihood Lower More Acceptable with Mitigation Unacceptable Less cceptable FIGURE A-3. SAMPLE RISK LIKELIHOOD/RISK SEVERITY MATRIX Risk Severity Risk Likelihood Catastrophic Hazardous B Major C Minor D Negligible E Frequent 5 5A 5B 5C 5D SE Occasional 4 4A 4B 4C 4D 4Е Remote ЗА ЗВ 3D ЗЕ Improbable 2 2A 2B 2C 2D 2E Extremely 1 1A 1B 1C 1D 1E Improbable NOTE: The direction of higher scales on a matrix to represent the direction of likelihood and severity are at the discretion of the organization.
Appendix A A-S. RISK ANALYSIS MATRIX EXAMPLE. The definitions and design of a risk analysis matrix is left to the HAA operator. This ensures each of the operator's decision tools is relevant to its specific needs and requirements. An example of a two-sided paper form used by one HAA operator is shown in two figures below. Note that the numbers associated with each option do not represent universal best practices, but rather represent an analysis of their meaning for that specific operator. Not only the value assigned to each factor, but the factors selected, reflect the operator's needs. For example, as in this example, an operator in an inland area would not have to consider quantification of overwater flights, while one operating on an island would have to do so.
FIGURE A-4. SAMPLE RISK ASSESSMENT MATRIX SHOWING
QUANTIFICATION OF FACTORS (FIRST PAGE OF A TWO-PAGE FORM)
RISK ASSESSMENT WORKSHEET "SHORT FORM" Pilot: Base:
Date Mission #:
EXPERIENCE:
HAA EXPERIENCE: (Choose all that apply) Less than 1 year +10 points 1-3 years +5 points 3-5 years +2 points p5 years 0 points Homebase: 0 points Unfamiliar Area: +10 points SPECIFIC TYPE EXPERIENCE:
Less than 100 hours +10 points More than 100 hours 0 points Unfamiliar Aircraft +5 points WEATHER: (Choose all that apply) DAY: NIGHT:
Jagged / Mountainous Terrain +5 points +10 points Ceiling between 1000' AND 1500" AGL +3 points +7 points Ceiling less then 1000° AGL +7 points +15 points Visibility between 3 - 5 miles +3 points +5 points Visibility less then 3 miles +7 points +15 points emperature and Dew Pt spread less than 5 +3 points +7 points Wind in excess of 15 Knots +3 points +5 points Storms along route of flight +5 points +10 points MISSION: (Choose one) DAY: NIGHT:
All within local area 0 points +5 points Any or all Cross Country +5 points +10 points TOTAL If total is less than 35, flight is at your discretion!
For totals 35 or greater, fill out worksheet on reverse CONSULT FDA ON RISK ASSESSMENTS 35 & ABOVE Page 5
Appendix A FIGURE A-5. SAMPLE RISK ASSESSMENT MATRIX SHOWING
QUANTIFICATION OF FACTORS (SECOND PAGE OF A TWO-PAGE FORM) Risk Assessment Worksheet "Long Form" IF SHORT FORM IS 35 OR GREATER - WORK THIS SHEET.
Do not carry over numbers from other side!!
EVENT ASSESSMENT VALUES Score 2 4 Shift 1st 1/2 day shift 2nd 1/2 day shiff 1st 1/2 nite shift 2nd 1/2 nite shift Time with company ≥2 years ≥1.5 years >1 уваг < 1 year Days on duty 1 to 2 3 to 4 5 to 6 More than 68 R/W EMS Experience 22 years > 1.5 years ≥ 1 year < 1 year Familiarty with area & 2 years 1 year to 2 years 6 months to 1year < 6 month Experience in type > 500 hours 100 - 500 hours 25 - 100 hours < 25 hours Length of longest leg < 25 nm 25 - 50 nm 50 - 70 nm > 70 nm Pre-mission planning > 30 min 10 - 30 min 5 - 10 min < 5 min Mission number today 2nd 3rd 4th 1st or >4 Last min changes none minimal some major Pilots attitude calm alert. excited angry / frustrated Personal life factors Normal Elevated Stress Prolonged Stress Life Changing Event Physiological factors well rest/good diet good rest/ fair diet marginal rest/diet minimum rest/diet Time of Day moming aftemoon night dawn / dusk Weather CAVU VMC MVMC MVVIC > Imc Turbulence smooth Light chop moderate mod to severe Wind calm 5 - 10 knots 10 - 20 knots >20 knots Gust Spread 0 - 5 kts 5 - 10 kts > 10 kts spread Precipitation none light moderate heavy Temperature 70 - 40 F 30-40 For 70/60 F 10-30 For 80-90 F < 10 F or > 90 F probablity of unforcast wx none small maybe likely Density Altitude sea leval 3-5K 5-8K high Terrain flat roling jagged mountainous High obstructions none tew occassional frequent Forced landing sites frequent some few none Take off area Heliport large open area somewhat confined sma area Landing area Heliport large open area somewhat confined sma area Tempo of operations easy normal too slow too fast Fuel on board 1hr more than needed 30-59 more than need 15-29 more than need minimum MEL equipment inop None/Accessory Comm nav lights instrument Loaded weight operational light moderate max gross TOTAL EXERCISE CAUTION !!
< 35 low nSk Pilots Choice 35 - 60 low to mod risk Exercise Caution 81 - 99 mod to high risk Exercise Extreme Caution 100 & above high risk NO GO
FDA CONSULTATION REQUIRED FOR ALL RISK LEVELS ON LONG FORM Pilot: Base:
Date Mission #:
START WITH OTHER SIDE !!
Appendix B APPENDIX B. SAFETY MANAGEMENT SYSTEMS (SMS) B-1. PURPOSE OF THIS APPENDIX. The information in this appendix is provided to give a helicopter air ambulance (HAA) operator information concerning the current state of safety management through an overview of safety management systems (SMS). Additional information and resources on SMS can be found in the current edition of Advisory Circular (AC) 120-92, Safety Management Systems for Aviation Service Providers. The Federal Aviation Administration’s (FAA) SMS Program Office (SMSPO) provides tools to assist with implementation of the SMS Voluntary Program (SMSVP). These are intended for use by operators to achieve compliance with the safety assessment requirements of Title 14 of the Code of Federal Regulations (14 CFR) part 135, § 135.617 through implementing a formal SMS within their organization. The SMSPO can be contacted at the following Web link:
http://www.faa.gov/about/office_org/headquarters_offices/avs/offices/afs/afs900/sms/.
B-2. OVERVIEW. One of the primary goals of an effective SMS is the development of a mature and positive safety culture. Internal and external audits provide assurance that processes are working as designed and continuing to be effective. While it is possible to have a positive safety culture without a formal SMS, a strong safety culture can be fostered by the implementation of an effective SMS. The constant attention, commitment, and visible involvement provided by all levels of management, combined with continuing data analysis, Safety Assurance (SA) activities and daily application of risk analysis and control techniques drive the organization toward safety culture maturity.
a. Confidential Employee Reporting Systems. Are essential components in assuring safety. They provide employee feedback for identifying new hazards and revising procedures.
b. Safety Management is a Learned Skill. Organizations do not simply adopt a software program or a set of posters and buzzwords, attend an hour of slide presentations and instantly install an effective SMS. As with any skill, it takes time, practice, repetition, the appropriate attitudinal approach and good coaching.
c. The Safety Culture Matures as Safety Management Skills are Learned and Practiced. The safety culture becomes second nature across the entire organization as trust builds and the organization functions as a team. The mature safety culture should have the following conditions to flourish.
(1) Openness. The organization encourages and even rewards individuals for providing essential safety-related information which will improve the operation.
(2) Justness. The organization takes a proactive approach toward error disclosure yet demands accountability on the part of employees and management alike. The organization engages in identification of systemic errors through root cause analysis and implements preventative corrective action. It exhibits intolerance of undesirable behavior (i.e., recklessness and willful disregard for established procedures).
(3) Involvement of All Levels of Management. This is demonstrated by:
Appendix B
• Formal risk analysis and resource allocation, as needed to assure mitigation of high consequence, high probability risks;
• Management action beyond rhetoric, actively involved in the decisionmaking processes and participate in safety activities; and
• Strong SA, combined with safety data analysis processes, yielding information, are used to drive risk reduction. An informed organization can take appropriate action to prevent accidents.
(4) Training. This includes training in threat recognition, error management and SMS, SA and Safety Risk Management (SRM) techniques.
(5) Flexibility. The organization uses information effectively to adjust and change in an effort to reduce risk. All aspects of the organization are under constant review and adjustment to meet changing demands.
(6) Learning. The organization learns from its own failures and those of similar operations. The organization uses acquired data to feed analysis processes, which yield information that can be, and is, acted upon to improve safety. Organizational behavior is modified accordingly. Actual practices are based upon accurate and validated information.
d. Accountability. To foster the development of a mature organization with a positive safety culture, an accountable executive must be in place.
(1) The accountable executive is the person who is the final authority over operations, controls, financial and human resources and retains ultimate responsibility for safety performance of the operation.
(2) All of the management staff, at all levels, should convey, enhance and emphasize the organization’s safety policy through exemplifying the policy in their daily work and in their one-on-one leadership styles. Decisionmaking should be kept at the lowest level appropriate to the complexity and criticality of the decision. Line managers are the people that own the process.
They are in the best position to make appropriate changes. Senior management, including the accountable executive, should monitor actions and provide guidance.
B-3. SAFETY MANAGEMENT SYSTEM (SMS) TOOLS.
a. SMS. The FAA has developed tools for implementing a SMS that are scalable and customizable to operators’ size, scope and environment. Two key components of a SMS are SRM and SA. Refer to the current edition of FAA Order 8040.4, Safety Risk Management Policy, for more information. An operator that implements safety management practices using a SMS will have these components integrated into its operations. While current regulations do not require implementation of an SMS, voluntary implementation is encouraged.
b. Risk Analysis. Risk analysis is how an operator provides each pilot-in-command (PIC), Operations Control Specialist (OCS) and others involved in the decisionmaking process with a shared set of documented processes that have been the subject of training to identify conditions (hazards), which if not addressed could foreseeably cause an aircraft accident. This allows an
Appendix B Page 3 (and 4) informed process to reduce associated risks by implementing appropriate processes and controls.
Risk analyses should also be performed under the following conditions:
(1) Implementation of new systems.
(2) Revision of existing systems.
(3) Development of operational procedures.
(4) Identification of hazards or ineffective risk controls through audits conducted through SA processes.
c. Systems.
(1) In the context of this AC, “systems” are limited to those processes and their associated personnel, facilities, tools, documentation and other resources that are needed to accomplish HAA-related functions.
(2) Every part 135 operator has a number of aviation-related “systems” such as flight operations, maintenance and inspection (frequently called “technical operations”), operational control and dispatch, medical and ground operations. Within these systems, many lower level processes and ancillary systems exist, such as training, fueling, biohazard decontamination, individual station operations and others.
d. Changes to Operations.
(1) Changes to a HAA operators operation could include the addition of new routes, opening or closing of line stations, adding or changing contractual arrangements for services, the addition of new aircraft types or major modifications to existing aircraft, addition of different types of operations such as night vision goggles (NVG) usage or any one of many different types of operations.
(2) Any of these additions or changes would trigger the use of an SRM process to determine if new hazards appear that would require incorporation of mitigations to reduce risk.
In many, if not most, cases, those controls will entail revision or addition of procedures and training for personnel engaged in the operation of the systems. For example, if a HAA certificate holder intends to implement NVG operations, they will need to organize their flight operations, maintenance, training and operational control systems to comply with the applicable regulations and guidance to ensure the NVGs are safely integrated into operations. They will also need to develop and document procedures for employees involved in those systems’ activities.
(3) In most cases, these procedures will be documented in the service provider’s manual system. The baseline for determining acceptable levels of safety for all service providers should be the existing regulatory standards, as applicable. Some mitigations and changes to the operation may require approval or acceptance by the FAA. The SA component provides processes for validation of the organizational processes and effectiveness of risk controls, once they have been implemented as the result of a risk analysis.
Appendix C APPENDIX C. HAA OPERATOR PILOT TRAINING PROGRAM AND
CHECKING EXAMPLES C-1. GENERAL. This appendix addresses, by providing examples, recommended approaches to the thorough ground and flight training and checking essential in the preparation of a pilot to safely assume the duties of a pilot in command (PIC) of a helicopter air ambulance (HAA). As in the other appendices, these are included as examples rather than being prescribed as an optimal solution. Following are some of the subjects that best practices of HAA operators have indicated should be addressed.
C-2. PILOT GROUND TRAINING – SAMPLE CURRICULUM OUTLINE. The focus of this curriculum is to outline topics specific to HAA operations.
A. Airman:
1. PIC Responsibility.
2. PIC Authority.
3. Flight and Duty Time.
B. General:
1. Definitions.
2. Hours of Operation.
3. Authorized Passengers.
4. Infection Control.
5. Cameras.
C. Preflight/Departure:
1. Visual Flight Rules (VFR) Flight Planning.
2. Base Flight Planning Documents and Material.
3. Weather Minimums – General.
4. Weather Minimums – Area of Operations Considerations.
5. Minimum Safe Cruising Altitudes (Operations Specification (OpSpec) A021).
6. Operations in High Wind Conditions.
7. Wind Requirements.
8. Local Flying Areas (LFAs).
9. LFA Pilot Testing/Examination Procedure.
10. Use of (Night Vision Imaging System (NVIS)) aided Minimums.
12. Weather.
13. Turndowns by Other Operators (and identifications of reason).
14. Routes of Flight - Single-Engine Helicopters.
15. Instrument Flight Rules (IFR) Operations (HAA-Specific Rules).
D. Operations Control Center (OCC):
1. Risk Matrix.
E. Refueling:
1. Engine(s) Off/Rotors Stopped.
2. Helicopter Rapid Refueling (HRR).
Appendix C F. Safety Briefing of Passengers/Medical Crew Members.
G. Initial Medical Crewmember Training:
1. General.
2. Training Program Contents/Requirements.
H. Crew Resource Management (CRM):
1. Crew Concept.
2. Pilot in Command (PIC).
3. Medical Crew.
I. Flightcrew Member Duties:
1. Pre-Launch Walk-Around.
2. Sterile Cockpit.
3. Engine Start.
5. Takeoff.
6. En Route/Cruise.
7. Before Landing (Prior to 2-Minute Estimated Time of Arrival (ETA)).
8. Arrival at the Intended Point of Landing.
9. Crew Callouts.
10. Aircraft Emergencies.
J. Crew Change:
1. Crew Change Operational Briefing Subjects.
2. Safety Precautions.
K. Patient Safety:
1. Loading and Unloading (engines running/secured).
2. Children/Infants.
L. Use of Seat Belts and Restraints:
1. Seat Belts and Shoulder Harnesses.
2. Infants and Pediatric Patients.
3. Aircraft Doors.
M. En Route:
1. Flight Plans and Flight Locating.
2. Position Reports.
3. Remote Area Communications.
4. Obstacles (including Wind Turbine Farms Wake Turbulence).
N. Arrival:
1. Landing Site Requirements.
2. Unimproved Landing Sites.
O. Equipment Familiarization (Securing, Storage, Weight and Balance (W&B), Loading):
1. Stretchers.
2. Isolettes.
3. Portable O2.
Appendix C
4. Balloon Pumps.
5. Ventilators.
6. Miscellaneous Equipment.
P. Emergency Procedures:
1. Emergency Evacuation Duties.
2. Hazardous Material Operations.
Q. Hazardous Patient Transport.
R. Public Relations Events:
1. Crew Duties – PR Events.
2. Landing Zone (LZ) Safety and Security.
C-3. PILOT FLIGHT TRAINING – SAMPLE CURRICULUM OUTLINE.
A. Module 1:
1. Preflight Procedures:
a. Med Crew Briefing.
b. Noise Abatement.
c. Hover/Ground Taxi Operations.
2. Takeoff and Departure Phase:
a. Normal/Crosswind.
b. Sidestep.
c. Maximum Performance.
d. PC2 (If Applicable).
3. Cruise:
a. Navigation.
b. Communication.
c. Severe Weather Avoidance.
d. Maintaining Situational Awareness.
e. Helicopter Terrain Awareness and Warning System (HTAWS).
4. Approach and Landing:
a. High Reconnaissance.
b. Low Reconnaissance.
c. Ground/Hazard Recognition.
d. Normal/Crosswind.
e. Sidestep.
f. Confined Area/Steep Approach.
g. PC2 (if applicable).
h. Special Conditions (including Flat Light/Brownout/Whiteout Ops and Multi-Aircraft Situations).
5. Emergency and Abnormal Situations.
6. Post-Flight Procedures:
a. Crew Debriefing.
b. Post-Flight Inspection.