Par 7-1 Page 55 CHAPTER 7. MANUALS, DOCUMENTATION, AND RECORDS
7-1. GENERAL. Title 14 of the Code of Federal Regulations (14 CFR) part 135 certificate holders conducting helicopter air ambulance (HAA) operations are subject to generally the same documentation and recordkeeping requirements as are other part 135 certificate holders, with a few additions.
7-2. MANUALS AND DOCUMENTATION. Part 135 certificate holders conducting HAA operations are required to compile and maintain Federal Aviation Administration (FAA)-approved procedures for preflight risk analysis (part 135, § 135.617) and visual flight rules (VFR) flight planning (§ 135.615). The following are subject matter areas which, due to either regulatory requirements or industry best practices, should be included in approved/acceptable documentation in a manual (or other accepted format) that goes beyond those required of other part 135 operations. The list below does not relieve the certificate holder from including other items in their operations manual as required.
a. General Operations Manual (GOM). It is recommended that each single-pilot and basic part 135 certificate holder conducting HAA operations, develop a GOM that covers the subject matter contained in §§ 135.23, 135.615, and 135.617. This manual should be available in each helicopter and at each location where flights are initiated.
b. Accident Incident Plan/Post-Accident Incident Plan (AIP/PAIP). All HAA operators, regardless of size, must establish accident and incident notification procedures, to include the local FAA office, National Transportation Safety Board (NTSB) and FAA certificate-holding district office (CHDO) telephone numbers. This is a requirement shared with other part 135 operations. Due to the nature of the distributed base operation generally conducted by HAA operators, this requirement may be somewhat more complex than a response plan for a single base non-HAA part 135 operation. (Refer to § 135.23(d).)
c. Rapid Refueling Procedures. Refueling with the engine(s) running, rotors turning, and/or passengers on board can be hazardous and must be accomplished in accordance with appropriate documented procedures and by trained personnel.
d. Fuel Quality. Due to the nature of HAA operations, many bases are at locations other than airports. It is recommended that operator-developed documentation define a program for determining and maintaining fuel quality. The operator may choose to procure fuel from commercial fixed base operator sources and/or maintain fuel quality within their own system throughout the chain of custody from receipt (from the distributor) to delivery (into the helicopter). It is recommended that the operator consult International Civil Aviation Organization (ICAO) Doc 9977 AN/489 Manual on Civil Aviation Jet Fuel Supply and the current edition of Advisory Circular (AC) 150/5230-4, Aircraft Fuel Storage, Handling, and Dispensing on Airports.
e. Procedures for Medical Equipment Installation and Removal. Removal and replacement of medical equipment items may have to be performed on a frequent basis. If the operation is simple, does not require tools, and can be done in accordance with approved data and procedures contained in the operator’s manual, any person trained by the certificate holder
Par 7-2 Page 56 may be authorized to remove or replace such equipment. If the operator chooses this option, they must include this training in their FAA-approved training and checking program. The HAA operator must document who is authorized to remove and replace equipment on its helicopters. If personnel other than certified mechanics will be removing or replacing equipment, they must do so in accordance with documented instructions and training provided.
f. Flight Authorization and Flight Locating Procedures and Operations Control Personnel Duties and Responsibilities. These should be well considered and be documented in the operations manual. For those operators with an Operations Control Center (OCC), a description of the duties and responsibilities of Operations Control Specialists (OCS) should appear in documentation (refer to § 135.619(c)). Operators not establishing an OCC should document procedures for comparable functions.
g. Local Flying Area (LFA) Documentation. Procedures for developing LFAs should be documented in accordance with § 135.611(a)(2). If any LFAs are proposed and accepted, a list of LFAs and a description of the examination that is given to pilots by the certificate holder enabling the use of alternative minima in these LFAs must be provided to the principal operations inspector (POI) for acceptance. (Refer to § 135.609 and Operations Specification (OpSpec) A021, Helicopter Air Ambulance Operations.)
h. Instrument Flight Rules (IFR) Operating Procedures. The FAA intends to facilitate use of the IFR system by HAA operations through developing approaches and departures to and from heliports that are not served by weather reporting and in accordance with Instrument Approach Procedures (IAP) and departure procedures Standard Instrument Departures (SID) and Obstacle Departure Procedures (ODP) that are developed specifically to serve these heliports.
Certificate holders should document procedures for IFR operations at locations without weather reporting (refer to § 135.611). The operator should document procedures for IFR operations using publicly available published IAPs or per privately developed, FAA approved special instrument procedures, point in space (PinS) approach procedures and SIDs/ODPs.
i. VFR Flight Planning Procedures. VFR flight planning procedures must, by regulation, be documented in accordance with § 135.615(d.) As part of the VFR planning process, operators must document their procedures for determining and documenting the highest obstacles and minimum obstacle clearance altitudes along intended routes of flight (including any contingency routes) prior to departure.
j. FAA-Approved Preflight Risk Analysis Procedures. Risk analysis procedures must be documented in accordance with § 135.617. These procedures are discussed in paragraph 3-4 and Appendix A of this AC.
7-3. RECORDS. Part 135 certificate holders conducting HAA operations are subject to recordkeeping requirements above those required of other part 135 operators not engaged in such operations. Records required by § 135.63 should be kept at an operator’s principal business office or other location(s) approved by the Administrator.
Par 7-3 Page 57 (and 58)
a. Pilot Training Records.
(1) LFA(s) Familiarity Verifications. A record of the 12-month local area demonstration or examination given to each pilot for each LFA assigned. (Refer to § 135.609.)
b. Non-Pilot Training Records. Also, see Chapter 4, Training Program.
(1) Preflight Risk Analysis Worksheets. Preflight risk analysis worksheets completed by pilots and OCS in compliance with § 135.617 are subsequently maintained in compliance with §§ 135.617 and 135.619.
(2) OCS. Training records are kept at least for the duration of that individual’s employment and for 90 days thereafter. Training records are required by § 135.619(e) to include a chronological log for each course, including the number of hours and the examination dates and results as well as copies of such examinations. Development of a record of OCS duty times would facilitate tracking.
(3) Maintenance Personnel. A recordkeeping system should be used allowing supplemental training to be verified and tracked.
(4) Medical Personnel. Each HAA operator must maintain a record of training for each medical crewmember that contains the individual’s name, the most recent training completion date and a description, copy or reference to training materials used to meet the training requirement. This must be maintained for 24 calendar-months following the individual’s completion of training.
c. Administrative Records.
(1) OCS Personnel. OCS personnel are among those employees for whom drug and alcohol testing program records must be maintained in accordance with 14 CFR part 120, §§ 120.105 and 120.215.
(2) Timekeeping. Each operator must maintain flight time and duty records for flightcrews. It is recommended that it do the same for OCS personnel to demonstrate compliance with duty time requirements.
Par 8-1 Page 59 CHAPTER 8. SAFETY
8-1. GENERAL. This chapter is intended to make current and potential operators aware of considerations underlying the safety culture that is central to best practices throughout helicopter air ambulance (HAA) operations. An effective safety program should be developed considering all aspects of the operator’s policies and procedures essential to the safe completion of a HAA flight. Best safety culture practices, even where they are not an explicit part of the regulations, facilitate compliance and enhance safety. Examples of ways to foster the safety culture are presented in greater detail in Appendix B of this advisory circular (AC).
8-2. SAFETY CONSIDERATIONS FOR HAA OPERATIONS.
a. Safety Commitment. Commitment to safety should start at the top of an organization.
The single most important element of a successful safety program is the commitment of senior management. Safety cannot be dictated; it should be practiced. Managers should lead by example and display a safety-conscious attitude including being involved in safety activities. Operators should conduct regular base safety meetings for all affected base and flight personnel.
b. Safety Management System (SMS). Establishment of an effective SMS helps implement a safety culture to address safety considerations unique to HAA operations. Examples of the use of a SMS are provided in Appendix B of this document.
c. Safety Personnel. The HAA operator should designate a safety officer. This individual should be familiar with each aspect of an HAA operation with particular emphasis on safety requirements unique to helicopters. This individual should plan, organize and disseminate information about the safety program to all involved persons. The safety officer should make an effort to reach out to relevant helicopter information sources and organizations such as the International Helicopter Safety Team (IHST), U.S. Helicopter Safety Team (USHST), and Helicopter Association International (HAI) and carefully review the wide range of fact sheets and toolkits available for applicability to their own operations.
8-3. ROLE OF COMPANY PHILOSOPHY AND EXECUTIVE/SENIOR MANAGEMENT.
a. Management Commitment. The regulatory requirement for some HAA operators to establish an Operations Control Center (OCC) (and the recommendation that those not so required carry out OCC functions) is likely to require the commitment of management to be effective. Many existing communication centers have evolved and operated mostly autonomously since their inception. HAA operators may experience difficulty transitioning from the previously autonomous communication centers as an OCC comes online. Management should plan to overcome these issues through education and communication.
b. Philosophy. In is important that an HAA operator’s entire organization embrace and promote a cohesive operational philosophy that provides direction for an OCC (or its functions) and the enhanced operations control procedures described in this AC. The instillation of a company philosophy that enhanced flight operations described in this AC are a team effort. They are not simply a matter of a flightcrew receiving basic flight request information and then it being the flightcrew’s responsibility to complete the flight.
Par 8-4 Page 60
8-4. EMERGENCY OPERATIONS. The longer that an OCC and enhanced operations control procedures described in this AC are used, the more the organization relies upon their availability.
This may result in increasing impact on the ability of the organization to continue functioning if these are interrupted.
a. Documentation. It is recommended that HAA operators prepare emergency procedures that most effectively leverage resources available to the operator, including the OCC. This will include, but may not be limited to those procedures documented by the applicable Accident Incident Plan/Post-Accident Incident Plan (AIP/PAIP). Such procedures should be prepared to provide guidance on how to carry out HAA operations in emergency or degraded capability situations and to manage the partial or total loss of critical capabilities such as OCC and enhanced operations control functions.
b. Training and Drills. It is recommended that an HAA operator conduct regular refresher training and drills to maintain the organization’s ability to follow these procedures.
Drills should be conducted annually at minimum; more often is preferred.
Appendix A APPENDIX A. SAMPLE RISK ANALYSIS TOOLS A-1. PURPOSE OF THIS APPENDIX. The information in this appendix is provided to assist in developing a risk analysis process. It provides examples of approaches that may be used by a helicopter air ambulance (HAA) operator to assess, mitigate, and manage risk. Additional information on risk analysis management can be found in the current edition of Advisory Circular (AC) 120-92, Safety Management Systems for Aviation Service Providers.
a. Background. Title 14 of the Code of Federal Regulations (14 CFR) part 135, § 135.617 requires preflight risk analysis to be conducted as part of the overall risk analysis and, where applicable, be supported by an operator’s Operations Control Center (OCC). These requirements should be implemented within a broader framework of organizational systems, including policies, procedures, training and supervision that have been developed based on assessment of day-to-day HAA operational risks.
b. Risk Assessment. The risk assessment process should produce a quantitative result.
The process involves identifying hazards associated with a proposed operation and assessing risks associated with each hazard. After risks are assessed, risk mitigation strategies can be identified, developed and implemented. If mitigations will not reduce risk to an acceptable level, a flight should not be authorized.
c. Risk Analysis Components. Risk analysis has two components that are assessed:
severity (what is the worst probable outcome) and likelihood (of occurrence). Severity refers to the consequences of an event resulting from the hazard. Likelihood is an estimate of how likely the event is to occur. If the likelihood of an event is estimated to be high, and the consequences potentially severe, the risk analysis would indicate that the flight should not be operated until the identified hazards are eliminated or suitable mitigations have reduced the risk to an acceptable level.
A-2. SEVERITY AND LIKELIHOOD CRITERIA. This appendix provides some examples of one effective tool that has been used by several HAA operators and is intended to be functional for everyday operations without being cumbersome. As throughout the AC, the focus of this appendix is on the results it yields to inform regulatory required actions and it is not intended to prescribe the use of a particular methodology of process. The definitions and design of the final matrix is left to the HAA operator. The definitions of each level of severity and likelihood will be expressed in terms realistic for the individual operational environment and operator’s profile. This ensures the relevance of decision tools to the operator’s specific needs.
An example of severity and likelihood definitions is shown in the table below.
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 !!