Safety Recommendation A-06-013

We are aware that, in section 135.617, the February 21, 2014, final rule requires all helicopter air ambulance operators to establish and document, in their operations manual, an FAA-approved preflight risk analysis that includes management approval whenever a predetermined risk level is exceeded. Accordingly, Safety Recommendation A-06-13 is classified CLOSED—ACCEPTABLE ACTION.

The FAA’s proposed revision to 14 CFR Part 135 to require an FAA-approved procedure for conducting pre-flight risk analyses when helicopter air ambulance operations are being conducted would satisfy the intent of this safety recommendation, if enacted. This requirement, combined with the proposal to mandate briefings by the pilot in command or designated crewmember to medical personnel prior to each helicopter air ambulance operation and the proposed requirement for an operations control center and operations control specialists for helicopter air ambulance operations, would improve the safety of helicopter emergency medical services (HEMS) operations.

Accordingly, pending the expeditious issuance of a final rule as proposed, Safety Recommendation A-06-13 is classified OPEN—ACCEPTABLE RESPONSE.

-From Michael P. Huerta, Acting Administrator: On October 12, 2010, the FAA issued Notice of Proposed Rulemaking (NPRM), Air Ambulance and Commercial Helicopter Operations, Part 91 Helicopter Operations, and Part 135 Aircraft Operations; Safety Initiatives and Miscellaneous Amendments. The comment period closed on January 10, 2011. The FAA received the comments submitted by the Board and is reviewing those comments as part of the rulemaking process. The NPRM proposes to add requirements for: • A load manifest for all aircraft operated under part 135 (§ 135.63(c)); • Radio altimeters for all helicopters operated under part 135 (§ 135.160);

• Initial and recurrent pilot testing to include procedures for aircraft handling in flat-light, whiteout, and brownout conditions (§ 135.293(a)(9)); • Competency checks that include a demonstration of the pilot's ability to maneuver solely by reference to instruments (§ 135.293(c)

Notation 8272: The National Transportation Safety Board (NTSB) has reviewed the Federal Aviation Administration's (FAA) Notice of Proposed Rulemaking (NPRM) titled "14 CFR [Code of Federal Regulations] Parts 1, 91, 120, and 135 Air Ambulance and Commercial Helicopter Operations, Part 91 Helicopter Operations, and Part 135 Aircraft Operations; Safety Initiatives and Miscellaneous Amendments; Proposed Rule," which was published at 75 Federal Register 62640 on October 12, 2010. The FAA proposes requiring HEMS certificate holders to implement preflight risk assessment programs.

All HEMS operators would be required to conduct a formal preflight risk assessment before each HEMS mission and consider the risks associated with each leg of the mission. The FAA also proposes that the risk assessment procedures be documented and included in the certificate holder’s operations manual. The goal of this proposed rule is to ensure that standard preflight risk assessment guidelines are used. The NTSB notes that this proposed change, if adopted, would be responsive to Safety Recommendation A-06-13.

While the NTSB supports this rule change, it does not believe that this requirement should be a substitute for the additional safety benefits that would be provided by OCCs. The NTSB believes that preflight risk assessment and support from OCCs are complementary activities. Safety Recommendation A-06-13 asks the FAA to “require all emergency medical services (EMS) operators to develop and implement flight risk evaluation programs that include training all employees involved in the operation, procedures that support the systematic evaluation of flight risks, and consultation with others trained in EMS flight operations if the risks reach a predefined level.”

The recommendation is currently classified “Open—Acceptable Response” and is on the NTSB’s Most Wanted List.

Over the years, the FAA has developed and published guidance that addresses decisionmaking skills and flight risk evaluation programs for HEMS operators, including, most recently, the inclusion of this information into FAA Order 8900.1. The NTSB has reviewed this guidance and found it to be valuable; however, this recommendation is for the FAA to establish a requirement for the use of these plans for all HEMS operations. During 2008, the FAA met on several occasions with the HEMS industry, and the industry agreed to voluntarily implement flight risk assessment programs. The FAA reported that as of February 2009, the industry had achieved 94-percent compliance with the guidance.

The FAA had previously informed the NTSB that it planned to mandate flight risk evaluation plans through revisions to the OpSpecs covering HEMS operators. In lieu of an OpSpec revision, the FAA has now decided to pursue rulemaking to ensure 100-percent compliance. The FAA stated that the NPRM for air ambulance and commercial helicopter operations will propose a requirement for use of a formalized flight risk evaluation plan for HEMS operations.

Although the NTSB believes that a regulation is needed and that an NPRM is the first step in implementing a regulation, we are concerned that often FAA regulatory development projects require considerable time to issue the NPRM and to enact the final rule. A requirement for the development and use of formalized flight risk evaluation plans should have minimal implementation costs and, given the widespread voluntary compliance the FAA has reported, should encounter little opposition. We hope that this requirement will be implemented in a timely manner. The NTSB looks forward to the opportunity to review the NPRM when it is issued.

At the February 18, 2010, meeting, Safety Recommendation A-06-013 remained classified OPEN -- UNACCEPTABLE RESPONSE. Pending timely enactment of a final rule that includes a requirement for the development and use of flight risk evaluation programs by all EMS operators.

Safety recommendation A-06-013 was reiterated in the accident report: Crash during approach to Landing of Maryland State Police Aerospatiale SA365N1, N92MD, in District Heights, Maryland on September 27, 2008. (adopted 11/13/2009, AAR-09-07). The FAA has provided guidance on the development and use of flight risk evaluation programs by EMS operators but has not required that all EMS operators implement flight risk evaluation programs. As a result, Safety Recommendation A-06-13 was classified OPEN -- UNACCEPTABLE RESPONSE. The NTSB believes that this accident demonstrates evaluation programs. Therefore, the NTSB reiterates Safety Recommendation A-06-13.

Letter Mail Controlled 8/31/2009 10:34:54 AM MC# 2090543: - From J. Randolph Babbitt, Administrator: 09 The FAA has developed and published a number of initiatives to address decision making skills and flight risk evaluation programs for HEMS operators. January 28, 2005, the FAA published Notice 8000.293, Helicopter Emergency Medical Services Operations, providing guidance for safety inspectors to help operators review pilot and mechanic decision-making skills, procedural adherence, and crew resource management practices (concepts now found in Safety Alert for Operators 06001);

August 1, 2005, the FAA published Notice 8000.301, Operational Risk Assessment Programs for Helicopter Emergency Medical Services (previously provided) providing guidance to inspectors promoting improved risk assessment, risk management tools and training to all flight crews, including medical staff; January 28, 2006, the FAA published Safety Alert for Operators 06001, Helicopter Emergency Medical Services Operations, which included the information from these Notices as well as additional information to operators (enclosure 3); and May 1, 2008, the FAA incorporated the risk assessment information into FAA Order 8900.1, FSIMS (enclosures 4 & 5).

After several FAA and HEMS industry meetings, the industry has agreed to voluntarily implement risk assessment programs. As of February 2009, the industry had a 94 percent compliance with this agreement. In lieu of an OpSpec, as indicated in our initial response, the FAA is pursuing rulemaking to ensure 100 percent compliance. We plan to complete work on the NPRM for air ambulance and commercial helicopter operations in January 2010. Publication of the NPRM will occur after clearance from DOT and OMB.

The National Transportation Safety Board met on October 28, 2008, to consider our list of Most Wanted Safety Improvements issued to Federal agencies. At this meeting, the issue Improve the Safety of Emergency Medical Services (EMS) Flights was added to the list, as were Safety Recommendations A-06-12 through -15, stated below. The Safety Board also reclassified three (A-06-12, -13, and -15) of the four recommendations.

All four recommendations were issued to the Federal Aviation Administration (FAA) as a result of the Safety Board’s special investigation of a number of aviation accidents between January 2002 and January 2005 involving aircraft performing EMS operations. In May 2006, the FAA indicated that it planned to add a specific requirement for a risk assessment program to OpSpecs A021 and 024. The FAA stated that these revisions would be completed by September 2006.

At the end of December 2006, the Board verified that the revisions had not yet been incorporated into the OpSpecs; nevertheless, on April 3, 2007, Safety Recommendation A-06-13 was classified Ope Acceptable Response, pending the addition of this requirement to the OpSpecs. As of the date of this letter, the FAA has still not completed this action.

In August 2005, the FAA issued Notice N8000.301, Operational Risk Assessment Programs for Helicopter Emergency Medical Services, which provided detailed guidance on the development and use of flight risk evaluation plans by EMS operators. This notice expired in August 2006, without further action for almost 2 years. In May 2008, the guidance within the expired notice was incorporated into FAA Order 8900.1, Flight Standards Information Management Systems.

Although guidance is valuable, Safety Recommendation A-06-13 asks for a requirement, such as an OpSpec, that all EMS operators develop and use flight risk evaluation programs. The Safety Board continues to investigate a number of accidents involving EMS flights and believes that the FAA’s failure to take action is not acceptable. Pending incorporation of a specific requirement into OpSpecs A021 and 024 to develop and use a flight risk assessment program, Safety Recommendation A-06-13 is classified OPEN -- UNACCEPTABLE RESPONSE.

Letter Mail Controlled 10/7/2008 1:08:49 PM MC# 2080609: - From Steven B. Wallace, FAA: On May 5, 2008, the FAA issued Advisory Circular (AC) 120-96, Integration of Operations Control Centers into Helicopter Emergency Medical Services Operations.

Letter Mail Controlled 7/2/2008 11:28:41 AM MC# 2080390: - From Steven B. Wallace, FAA: On May 5, 2008, the FAA issued Advisory Circular (AC) 120-96, Integration of Operations Control Centers into Helicopter Emergency Medical Services Operations.

In its May 30, 2006, letter, the FAA indicates that it plans to add a specific requirement for a risk assessment program to Operations Specifications (OpSpecs) A021 and 024 Emergency Medical Service in the next revision of these OpSpecs, scheduled for later this year; however, as of December 11, 2006, it has not been issued or added. Pending the addition of this requirement to the OpSpecs, Safety Recommendation A-06-13 is classified OPEN -- ACCEPTABLE RESPONSE.

Letter Mail Controlled 6/14/2006 10:24:44 AM MC# 2060276: - From Marion C. Blakey, Administrator: 5/30/06 On August 1, 2005, the FAA published Notice 8000.301, Operational Risk Assessment Programs for Helicopter Emergency Medical Services. I have enclosed a copy of the notice for the Board's information. The notice highlights the requirement cited in 14 CFR 119.69 for the qualified management and technical person to ensure the safety of its operations.

The person must be qualified through training, experience, and expertise; must have a full understanding of the aviation safety standards and safe operating practices; and be able to discharge their duties to meet applicable legal requirements and to maintain safe operation. The specific requirement to have a risk assessment program will be added to Operations Specification (OpSpec) A021 and 024 (Emergency Medical Service) in its next revision scheduled to be completed by September 2006. I believe that the FAA has satisfactorily responded to this safety recoinmendation, and I look forward to your response.

At the October 25, 2008 Board meeting addressing the NTSB’s Federal Most Wanted List of Transportation Safety Improvements (MWL), the Board voted to place Safety Recommendations A-06-12 through A-06-015 on the Federal MWL under the issue category “Improve the Safety of Emergency Medical Services (EMS) Flights.”