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Medical Helicopter Standards Proposed

Fri, Oct 22, 2010 — David Evans

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When the Congressional oversight committee issues a blanket statement of support for a proposed rule, one is left with the dismaying feeling the legislators don’t understand or don’t care.

Such is the thought attendant to the Notice of Proposed Rulemaking (NPRM) posted 12 October on the Federal Register. The NPRM is the long-awaited response by the Federal Aviation Administration (FAA) to improve the safety of helicopter emergency medical service (HEMS) operations. The HEMS industry has been plagued by a shocking frequency of accidents.

Sixteen HEMS crewmembers have been killed this year in accidents, an increase that recalls 2008, when a midair collision of medevacs helped drive the death toll to an all-time high of 28 crew members and patients.

Seven people died when two medical helicopters collided in AZ in 2008

FAA Administrator Randy Babbitt hailed the publication of the NPRM:

“We can prevent accidents by preparing pilots and equipping helicopters for all of the unique flying conditions they encounter. These new rules are designed to protect passengers, medical personnel, and pilots.”

Once again, the FAA seems to be plugging holes with frankly leaky regulations that address some issues while remaining silent about big changes that would really affect safety.

Nevertheless, the chairman of the House Committee on Transportation and Infrastructure and the chairman of the Aviation Subcommittee lauded the FAA’s action.

Rep. James Oberstar

Rep. James Oberstar (D-MN), chairman of the full Committee:

“I applaud FAA for this proposed rulemaking. This proposal covers helicopter air ambulance services, which have been of concern to the Committee. This rulemaking is consistent with air ambulance safety language in the FAA reauthorization bill that has won approval in the House.”

(L) Rep. Jerry Costello

Rep. Jerry Costello (D-IL), chairman of the Aviation Subcommittee:

“Today’s proposed rule by the FAA is a positive step to ensure that major safety improvements are made in the helicopter industry. I am pleased to see that the NPRM seeks to address many of the helicopter safety issues that the Subcommittee has outlined in oversight hearings … many of which have been on the National Transportation Safety Board’s [NTSB] ‘Most Wanted’ list for years.”

At least Costello acknowledged that the NPRM covers “many” safety issues, implying not all of them. Even the NTSB recommendations don’t cover all safety issues.

The proposed rule covers what might be called important “tactical” considerations while leaving “strategic” concerns unmentioned.

In terms of “tactical” initiatives, the FAA plan would require terrain warning systems, operation control centers for larger companies, pre-flight risk analysis – particularly regarding inclement weather – and stricter flight rules whenever medical staff – not just patients – are aboard.

Certain “strategic” issues were not discussed.

Divided among 70+ companies and public entities, the U.S. HEMS fleet numbers some 880 air ambulance helicopters. This number marks a 54% increase between 2003-2008, and the number continues to grow.

The reason for this explosive growth is to be found in Medicare boosting its reimbursement rate for HEMS flights. The spigot of new money expanded the market for private operators, who compete ferociously for business.

A typical HEMS flight can generate a payment of $20,000 or more. To garner these payments, operators have a built-in incentive to fly – despite such dangerous factors as marginal weather and night operations. One HEMS pilot described every patient as a golden trout. “We need to get these trout,” he said, because of the generous Medicare reimbursement.

The reimbursement rate is independent of the level of safety built into the operation. One can operate a 20-year old helicopter, with just one pilot, and the Medicare payment is the same as for a patient transported in a state-of-the-art helicopter flown by two pilots. The NTSB has mildly suggested to the Department of Health & Human Services (HHS) that it “If reimbursement rates should differ according to the level of HEMS transport safety provided.”

Reading the NPRM, it is evident that the FAA does not intend to link approval to conduct HEMS flights to any sort of graded HHS reimbursement rate based on safety.

A tiered reimbursement schedule, based on safety programs, would be exceedingly useful, if nothing else as a club to ensure compliance with FAA regulations and optional practices.

It is obvious that the more generous Medicare reimbursement since 2002 has spawned a competitive growth in the industry. The number of companies and helicopters is expanding, and they transport an estimated 400,000 patients and transplant organs each year. The HEMS industry is now about a $2.5 billion activity.

Maybe not all “golden trout” ought to be transported by helicopter. Ground transport would be adequate for many patients not suffering life-threatening time-sensitive illnesses or injuries.

The Canadian experience is instructive. The Canadian HEMS industry totals 20 helicopters covering the entire country. Contracts are awarded to the four companies providing the flights based on a request for proposal (RFP) process, and managed through Provincial Health departments.

In Canada, 20 helicopter ambulances cover the entire country.

In Canada, medical evacuation helicopters fly to prepared landing zones; from the scene of the accident, patients are transported by ground ambulance to the landing zone. A minimum of 5 miles visibility is required in mountainous regions. The list of requirements goes on. Suffice to say, there is no mad competition for “golden trout” in Canada. The entire populated area of the country is covered by the four companies operating a grand total of 20 helicopters.

The safety record is commendable. The Canadians have never had a fatal accident involving a medical helicopter.

Now consider the state of Missouri, which has some 33 helicopters serving the sate. The number is up from 9 helicopters in 1985, largely as a result of the economic incentive provided by the Medicare reimbursement formula. In other words, one state has more helicopter ambulances than the entire country of Canada.

hems-2

The payment scheme may contribute to a phenomenon known as “press on” regardless, in which the evacuation flight may be launched and continued under marginal weather conditions to realize payment. Not to put too fine a point on it, but this is a scheme where the decision to fly is market driven. Medical necessity is frequently a second order (or lower) consideration.

The unparalleled growth in the HEMS industry has diluted safety, as evidenced by the accident record. Rather than looking for ways to increase the safety of America’s large fleet of market-driven air ambulance helicopters, the Canadian model should be examined with a view to emulation. This course might drive some marginal operators out of the business of transporting patients by helicopter. The counter argument is that if standards were codified to the level really needed to operate these flights safely, some companies would not be able to support the costs (especially if Medicare payments were linked to safety programs) and would be driven out of business anyway. A return to the fleet size prior to 2002 would not necessarily be a bad thing; market growth has been stimulated by the method of payment, not be a huge increase in patients requiring time-sensitive aeromedical transport.

If the U.S. adopted the same ratio of HEMS machines to population as the Canadians, the U.S. fleet would number about 350 helicopters. This total would mark a reduction of at least 500 helicopters (almost 60%) from the 850 now competing for “golden trout.”

In addition to method of payment independent of safety, the second “strategic” issue is the fact that HEMS operations are flown by just one pilot.

Helicopter ambulances are authorized by the FAA to be flown by one pilot, although helicopters are generally designed for two-pilot operations. Military medical evacuation helicopters are flown by two pilots. In Canada, which has not suffered a single fatal HEMS accident, two-pilot operation is required.

In the U.S., HEMS flights are routinely conducted by one pilot, often with a medical technician occupying the co-pilot’s seat to relieve the pilot’s workload by operating the radios, maintaining an external watch for obstacles, and so forth.

It should be noted that no commercial airline flight would be undertaken by a single pilot. The airplanes and air traffic control procedures are based on two pilots sharing the workload. And these flights are conducted from one airport to another, under radar coverage from the ground while en route overland and in the vast majority of terminal areas. Moreover, commercial airline flights are conducted with installed safety systems where two pilots can enhance the response. These systems include TCAS (Traffic Alert Collision Avoidance System) and TAWS (Terrain Alert Warning System).

By contrast, HEMS flights are conducted to remote landing zones that may be a school parking lot or a highway, at low altitude, in precipitation, fog, hilly terrain and/or man-made obstacles (e.g. transmission towers and their guy wires). The HEMS flights are often conducted at night, without benefit of continuous air traffic control and surveillance, under extreme time pressure to retrieve a patient. How these operations were authorized to be flown by one pilot is a mystery.

The FAA says these helicopter ambulances, although designed for two-pilot operation, have been cleared for handling by just one pilot. The agency has declined to divulge information justifying this decision (such as reports of test flights, the risk matrices used, the problems attendant to one-pilot operation and how they are supposed to be handled).

If one were to ponder why the FAA is so circumspect about single-pilot operation – and willing to authorize same – the cost to operators lies darkly in the spectral background. Having to train and keep current two pilots, and pay their salaries, would probably render many of the proliferating operations non-viable.

All we know officially is that these operations are approved for single pilot conduct, medical technicians are frequently taking up en route flying workload, that the NPRM contains many initiatives that increase pilot workload, and that neither the U.S. military nor other countries operate these “angels of mercy” flights with just one pilot.

“Safety demands a requirement for two pilots,” asserts former NTSB Chairman James Hall. “While this NPRM is a step forward, it still leaves a single pilot with too many tasks to provide the safety margin necessary in the emergency care of human life.”

Moreover, Congress has abetted the “tactical” vice “strategic” approach reflected in the NPRM that the committee and subcommittee chairman now hail as a great leap forward. From its FAA reauthorization bill (H.R. 916) has provided loopholes galore. For example, matters to be addressed include “devices that perform the function of flight data recorders and cockpit voice recorders to the extent feasible…” The words “to the extent feasible” relegate flight data and cockpit voice recorders (FDR/CVR) – which the NTSB deems essential – to the “too hard, too expensive” pile of unrequited safety recommendations. Sure enough, the NPRM discusses a Light-weight Aircraft Recording System (LARS) to avoid the cost of fully functional and crash hardened FDRs/CVRs.

Congress seems to be abetting the status quo. The reality of the NPRM is being papered over with enthusiastic committee press releases. The situation in the medevac community is reminiscent of a proliferation of tow-truck drivers haunting known accident scenes and actively touting for business.

What needs to be addressed and changed, but isn’t in this NPRM, is the current payment formula, the excessive number of competing helicopter ambulances, allowing flights with only one pilot, and the need to establish a central operations center at least at the state level to suppress the operator’s fervent hunt for “golden trout.”

Over the years, the NTSB has issued numerous recommendations for heightening the safety of HEMS flights. The NTSB is now examining the NPRM to determine the extent and thoroughness of the FAA’s proposed actions. Herewith, a synopsis of NTSB recommendations, the current status of each proposal, and the extent to which the NPRM satisfies the intent of each recommendation:

Recommendation number A-06-12

Conduct all HEMS flights with medical personnel on board under Part 135 rules, which are more stringent than those under Part 91.

Classified “OPEN – Acceptable Response” based on FAA assurance the issue will be addressed in the NPRM. Note that the recommendation was issued four years ago, the NPRM was just issued; it will be at least a year before a final rule is issued, so it may take fully seven years to implement this minor change,

In the NPRM, the FAA says:

“This proposal should not require helicopter air ambulance certificate holders to make major operational changes because their operations generally include a Part 135 on each flight. Nevertheless, the FAA calls for comments on measures that it could take to address this proposed rule’s impact on the availability of air ambulance services.”

Comment: is the FAA trolling for a reason NOT to implement this rule?

Recommendation number A-06-13

Require HEMS operators to implement flight risk evaluation programs that include training all employees involved in the operation.

Classified “OPEN – Acceptable Response” with the hope of “timely enactment of a final rule.” As the recommendation was issued in 2006, “timely” seems debatable at this point.

In the NPRM, the FAA says:

“Certificate holders would be required to develop a method to determine whether the flight request had been offered to another company. This provision is intended to combat the practice of ‘helicopter shopping’ in which a flight request turned down by one company will be offered to another. If another company had been offered and refused the flight, it is important to understand why the flight was refused.”

The FAA believes its proposed actions are fully responsive to NTSB recommendation A-06-13 and partially responsive to recommendation A-09-89 below.

Comment: a statewide dispatch center could actively suppress the practice of “helicopter shopping” and pursuit of the proverbial “golden trout.”

Recommendation number A-06-14

Require EMS operators to use formalized dispatch and flight-monitoring procedures that include up-to-date weather and assistance in flight risk assessment decisions.

Classified “OPEN – Acceptable Response” despite the long awaited NPRM. The NTSB noted, “After the FAA completes drafting of the NPRM, the document will need to be reviewed and approved by the Office of the Secretary of Transportation, followed by review and approval by the Office of Management and Budget.”

The FAA asserts that this requirement will be implemented for all operators with 10 or more ambulance helicopters, thereby covering 620 of the 884 helicopters engaged in medevac operations. Regarding the flight risk assessments, the FAA proposes that the pilot in command complete and sign a formalized worksheet (the NTSB found that some pilots were conducting a “mental risk assessment”). Of genuine benefit as a check and balance, the FAA requires a company operations control specialist to countersign the worksheet. The FAA is rather vague about what happens when the pilot and the flight control specialist disagree on the risk assessment.

And, unlike pilots, the FAA wonders if these operations specialists should be licensed, a notion that would seem to be self-evident:

“Although not specifically proposed here, the FAA seeks comment on whether to require operations control specialists to obtain a certificate of demonstrate proficiency from the FAA. The FAA is considering this requirement because it would enable the agency to suspend or revoke an operation control specialist’s certificate of demonstrated proficient, thereby ensuring that person could not continue to hold the … position if his or her actions merited such a response. Individuals would not be permitted to serve as an operations control specialist without obtaining a certificate of demonstrated proficiency.”

Elsewhere in the NPRM, the FAA puts the onus on the pilot:

“The pilot … would be required to sign the completed risk analysis worksheet, and provide the date and time of signing. Though this requirement, the FAA intends to highlight that the pilot is responsible for accurately completing this worksheet.”

The role of the operations control specialist is not mentioned. In airline operations, the decision to conduct a particular flight is made jointly by the pilot in command and the dispatcher.

Recommendation number A-06-15

Install terrain awareness and warning systems (TAWS) on helicopters and provide training in their use.

HTAWS provides the pilot with warning of terrain and man-made obstacles along the flight path.

Classified “OPEN – Unacceptable Response” and the NTSB “remained concerned about the time required to develop and issue this requirement.”

In the NPRM, the FAA says:

“HTAWS [Helicopter TAWS] has particular relevance to helicopter air ambulance operations, which often are conducted at night and into unimproved landing sites … Under the proposal, the FAA would give certificate holders 3 years from the effective date of the final rule to install HTAWS … a 3-year compliance period will permit certificate holders to spread out the cost of compliance over that period of time.”

Comments: note the concern about costs, but no mention about the imperative to improve safety. The installation timeline proposed by the FAA mans the last EMS helicopter will be outfitted with HTAWS in 2014, or about 8 years after the NTSB recommendation.

Recommendation number A-09-87

Develop training for pilots that covers inadvertent flight from visual meteorological conditions (VMC) to instrument meteorological conditions (IMC) and determine how frequently such training is needed for proficiency.

No official NTSB classification of this recent 2009 recommendation.

In the NPRM, the FAA says it is proposing:

1. An increase in VFR weather minimums,

2. To allow IFR operations at locations without weather reporting.

3. To specify procedures for VFR transition to IMC.

The FAA explains why it proposes allowing IFR at locations without weather reporting:

“The proposed rule would allow certificate holders to obtain operations specifications permitting IFR operations into and out of locations without a weather reporting facility located within 15 NM of the destination landing area. The FAA believes that this provision would increase the use of IFR by helicopter air ambulance operators and result in more aircraft operating in a positively controlled environment, thereby increasing safety.”

But there is no requirement for pilots certified on instrument flight to maintain IFR currency.

Recommendation number A-09-89

Require HEMS operators to implement a safety management system (SMS).

Classified “OPEN – Initial Response Received.” The NTSB has not released the FAA response, pending evaluation of its adequacy.

The FAA maintains in its NPRM:

“This proposed regulation would partially address NTSB Safety Recommendation A-09-89 regarding the implementation of sound risk management practices, could contribute to a certificate holders overall safety program … In particular, an operations control specialist would provide additional input on proposed operations and be able to monitor flights, potentially helping pilots avoid dangerous situations.”

Comment: the NTSB has in mind a more generalized, total SMS addressing all areas of operation than the NPRM addresses.

Recommendation number A-09-90

Install flight data and voice recorders (FDR/CVR) in HEMS and establish a flight data monitoring program that reviews data to identify deviations from established norms.

Classified “OPEN – Initial Response Received.”

In the NPRM, the FAA says:

“The costs of … the CVR and the FDR equipment could prove to be prohibitive for this applications … The FAA acknowledges that LARS does not have the same crash survivability as CVRs and FDRs … Nevertheless, the FAA believes that LARS will yield beneficial data when used in helicopter air ambulances … LARS could provide precise technical data regarding the flight, such as heading, altitude, and attitude that may otherwise be unavailable. The FAA asks for comments on whether LARS will provide data that is valuable in an accident investigation.

“Although CVRs provide excellent post-accident information, the CVR data alone dos not provide adequate information for an accident prevention program.”

Comment: The last FAA assertion may have merit, but real insight comes when CVR recordings are overlaid on FDR data. The NTSB has used both CVR and FDR data in accident investigations. The suggestion that LARS will suffice seems driven entirely by the cost of retrofit.

Of the seven NTSB recommendations, it seems fair to say that three of them will not be satisfied through this NPRM, over and above delays in implementing any of the seven.

Some additional observations are provided in the summary of the NPRM provided below.

Federal Register

12 October 2010                Federal Aviation Administration (FAA)

FR Doc 2010-24862             Docket No. FAA-2010-0982

NPRM, Air Ambulance and Commercial Helicopter Operations, Part 91 Helicopter Operations, and Part 135 Aircraft Operations; Safety Initiatives and Miscellaneous Amendments

The rationale for the 58-page NPRM is stated plainly:

“From 1992 through 2009, there were 135 helicopter air ambulance accidents, including one midair collision with another helicopter engaged in air ambulance operation. These helicopter air ambulance accidents resulted in 126 fatalities ….

“This proposal, if adopted, would implement new regulations, and revise existing regulations, to address the causes and factors of commercial and helicopter air ambulance accidents identified by the FAA and the NTSB.”

Among the provisions in the proposed regulation:

“The FAA is not proposing that a helicopter air ambulance pilot maintain instrument proficiency.” Comment: with only one pilot, and the propensity for VFR conditions to degrade to IMC conditions, instrument rated pilots would seem to be de rigueur.

“The FAA recognizes that the current rule permits helicopters to travel long distances from shore without carrying safety equipment other than flotation devices and life preservers, as long as they remain within 50 miles of an offshore heliport. In the Gulf of Mexico, for example, some offshore oil platforms are located 150 NM from the shoreline … the FAA believes that this change would increase safety by eliminating the ability to hopscotch from heliport to heliport at great distances from shore without carrying water survival safety equipment.” Comment: Amen.

“The estimated mean benefit value for the air ambulance provision is $270 million … The FAA estimates the cost of this proposed rule for the air ambulance provisions would be approximately $210 million.” Comment: these costs and benefits are spread over 10 years. Thus, the costs average $21 million per year. One wonders if a favorable cost-benefit ratio would still prevail if operators with less than 10 helicopters were included in all provisions.

The NPRM does not cover “public use” operations such as the Maryland State Police Helicopter fleet. These operators could be regulated by the FAA if they have a Part 135 certificate, but the Maryland police operation presently does not.

Recall that a Maryland State Police helicopter on a medevac mission crashed in September 2008. The pilot, two medical technicians and one of two patients on board were killed. The other patient suffered serious but not life threatening injuries. The helicopter was not equipped with HTAWS, among other shortcomings. (See Aviation Safety Journal, November 2009, “Helicopter Accident Reveals That ‘Safe’ Operation Was Shot Full of Holes”)

The scene of the Maryland State Police crash.

A spokesman for the Maryland State Police said the department is now pursuing Part 135 certification. This option is not addressed in the NPRM; given the sloppiness that surrounded the Maryland State Police flight operations, and the need for FAA oversight, this option should have been spelled out in the NPRM. The pilot of the crashed helicopter, by the way, was instrument rated but had only about 1.9 hours of actual instrument time in the two years preceding the accident.

The NPRM has no separate section dealing with autopilots, as it does for HTAWS, LARS and radio altimeters. The FAA said there are other NTSB recommendations for medevac helicopters, but it has determined they are “not ready for rulemaking at this time.” The NPRM does contain the notice that instrument flight rules approaches require that the helicopter be equipped with an autopilot. But the overall integration of HTAWS, radio altimeters, and such, with the autopilot is nowhere discussed.

The NTSB has recommended that HEMS operators install autopilots “if a second pilot is not available.” This recommendation subtly equates autopilots (as boosting safety) to adding a second pilot. It should be noted that two pilots and an autopilot is the norm for airliners.

Comments to the NPRM are due by 10 January 2011.

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