Breaking Down EMS Rules and Regs

The philosophy behind the regulatory process

 

 
 
 

Howard Rodenberg, MD, MPH | | Wednesday, February 13, 2008


In his previous article. "Philosophies of EMS Paychecks," Howard Rodenberg, MD, MPH, discusses this philosophy behind government regulations, such as salary ranges for public employees. In the case of EMS, the industry and the government ideally have one goal -- keeping patients safe and providing quality care. Why, then, does it seem there is animosity between these two parties?

The most obvious reason, of course, is that one party has the power, often enshrined in statute, to discipline the other. While it s true that ultimately one party (the government) works for the other (the governed), in reality the time frame of regulatory action and the layers of government between regulators and policy makers may make this fact seem irrelevant. However, to those actually in government, recognize this principle nearly every day as they respond to the continual inquiries by legislators and the public.

In looking at the issue of "power" in the regulatory relationship, you might be surprised to find how rarely it s actually used. Like many people, I came to government with the idea that regulators exist to make other people s lives miserable. I can still recall, when I was serving as the medical director of Volusia County (Fla.) EMS, the way that word spread like wildfire when a state EMS regulator was in town, and entire services mobilized around the mere hint of a visit. After all, they never call just to ask you to lunch.

(If you ll pardon a brief aside, this reminds me of some sage advice I received about being an ED physician. Your only other doctor friends will be ER docs, I was told, because any other doctor sees your call only as work. You re never asking them to lunch at three in the morning. And while my best doctor friends are indeed ED docs, the phone call principle even applies in that setting. In a past life, I worked with a group that also staffed an urgent care center that was always transferring patients to the main ED. One day, one of the urgent care gang called about a transfer, and I was in a sour enough mood that I gave him some not-so-good natured ribbing about never calling just to be social. About three days later, I got mine back. Picking up the phone, I heard him say in his high-pitched accent, Hey, let's go have food. I was incredulous and started to make plans when I heard him laugh. "Ha ha ha! Just kidding. I've got a patient for you! )

The perception is far from the truth. Contrary to popular belief, the vast majority of regulators are not out to "get" anybody. Their evaluations, promotions or even their jobs themselves do not depend upon their ability to find fault with those whom they inspect. Although it s probably true that, given an incredibly strict interpretation of the regulations, anyone can find fault with anybody at any time, that s not the name of the game. Much like an EMS continuous quality improvement (CQI) program, the effort is not designed to assign blame or to punish, but to help enhance quality. Most states feature a system of progressive enforcement with a set of warnings, counseling and educational processes before enforcement actions occur (the one exception is when an immediate threat to life and health is present, like when the boa constrictor lives uncaged in the basement of a day care home. You d be amazed). State employees recognize that fining or suspending services not only has an impact upon the service and its employees, but upon the community that depends on that service being present. Their goal is to keep folks not only in compliance, but in business.

Keeping the doors open

I can t attest to the experience of other states, but let me share some Kansas numbers with you to reinforce this point. For example, licensed child care and foster care facilities in Kansas pass their initial and annual inspections more than 70% of the time on the first try. If we look at those that pass after further education and counseling, without any kind of regulatory or enforcement action, it climbs to nearly 95%. And even within this small percentage of providers subject to administrative sanctions, such as fines or suspensions, much more than half of those are related to statutory issues. These include prohibited persons in the home or failure to renew the license in a timely manner.

The Kansas Department of Health and Environment (KDHE) sees similar distributions in the food service program, where more than 90% of the licensed establishments pass their inspections on the first try, and administrative action is taken on less than 2% of the licensees. And even within the regulatory program of the Kansas Board of EMS, only a small minority of services was subjected to administrative action.

Despite these numbers, a very vocal minority still complains loudly and bitterly about the regulatory process. If we discount those complaints that fall into the category of sour grapes, we find some of the other reasons for distrust between government and the regulated community. One is the concern for consistency. If we re all to live by rules and regulations, so the argument goes, then we need consistent enforcement across the board. What gets a mark in one county shouldn t get a wink and a nod in another. And everyone has the they got me, but let them go story to tell.

Consistency is key

The need for consistency in regulatory enforcement is critical. The regulations are constant and don t change from day to day. What may change is the way they re interpreted by individual inspectors. It s therefore incumbent upon the regulatory agency to do all it can to maintain consistency in the interpretation of rules. The agency can do so through statements of policy interpreting and explaining the regulations, through training of surveyors and inspectors, and through quality management programs such as "shadow surveying" and senior-level review of contemplated actions against a standardized enforcement matrix. But as the system is human-based, some degree of variability is to be expected. (I recall hearing once that if a biological system reaches a correlation level of 80%, it s doing pretty well. Humans are about the most complex biologic system I know.) I seriously doubt if we d be any better served by a bunch of robots who have an absolutely rigid basis of determining compliance with rules and regulations and who are unable to account for the unusual situation or circumstance. It s incumbent upon government to build in measures to enhance consistency, but it s similarly incumbent upon the community to recognize that as long as our systems are person-based, slight disparities in the process will exist.

If there s a better way to ensure consistency short of simply doing away with the regulating body (if there are no regulators at all, then there s no problem with consistency) while maintaining the preventive and quality aspects of regulation, I m open to it. Nonetheless, I suspect all but a few truly radical libertarians would support the need for some kind of regulation of society, just as law enforcement systems "regulate" criminal behavior. Until then, we ll do our best, and hope -- mostly in vain, to be frank -- for some understanding.

Regulations in the real world

A second issue concerns the regulations themselves. Regulations are often thought of as rules set in stone. It s easier to maintain consistency in interpretation and application if they don t change, and the rulemaking process itself is cumbersome. But there s little question that written regulations don't always accurately reflect reality. Try as we might, the practical application of rules is complicated regulations that should work great in theory don t do so in practice. Any one who s done any disaster planning is well aware of this, as is anyone who s tried to apply their clinical care protocols regarding the use of head blocks and a backboard for spinal immobilization to the elderly lady with severe kyphoscoliosis who fell at the nursing home). So the regulatory process has to be fluid, and regulations need to be adapted to fit the world.

Just as a disaster plan on paper can rarely be followed once the real world intrudes, changes in the natures of our communities means that the regulatory environment needs to be flexible as well. This flexibility is different than flexibility in interpreting individual regulations; that kind of flexibility promotes inconsistency, the exact opposite of the regulatory program s intent. Instead, I m referring to the willingness to revisit regulations to ensure they reflect current science and thought. Many of the complaints about regulatory programs refer to regulations that need to be changed. In some cases, regulators couldn t agree more.

Although it s true that regulations need to be updated periodically, how often that should be will differ between programs, and between rates of scientific advances and social changes, in the regulated communities. The "magic number" of years between regulatory revisions is really unknown. I would simply offer the caveat that there is more danger, I think, in changing regulations too quickly in response to short-term needs or complaints than in offering a reasonable period of time to see the long-term benefit or challenge posed.

When regulations are developed, it s critical the regulatory body seek the input of the regulated community. "Seeking input" is different than "getting consent," and the two ideas are necessarily separate and distinct. Although I believe that the vast majority of EMS providers want to, and would, do the right thing even in the absence of regulation, many of them would be perfectly happy without it. "Getting consent," especially where regulated entities are formally organized, often means "backing off," which is contrary to the mission of the regulatory process. (This is, of course, assuming that you can get uniformity of opinion within the regulatory community itself. Requiring input, but not consent, is a way to keep competing interests balanced and focus the effort on the greater good. That, and there s a reason why it s called herding cats.) But a regulatory agency must hear from the "real-world" providers in order to understand the effect that the regulatory words have for the licensees. Kansas officials have used a process of bringing together a multidisciplinary group of professionals to review the latest knowledge and take public input before assembling revisions to a regulatory code. They ve successfully used this concept to draft foster care home regulations and are using the same process to begin our work on child care regulation.

It s also important to remember that, as previously mentioned, regulations are a creation of statute, which creates binds regulatory agencies to processes and procedures that may be in conflict with the community s needs. In these instances, the regulatory agency and the regulated community should persuade legislators that a better course exists. Further, it should be noted that regulations cannot cover every eventuality, just as EMS policies and protocols are always challenged by new, unusual and unforeseen circumstances. To expect the regulatory process to anticipate every challenge is illogical and unfair. These folks have a tough enough job without being seers.

The issue of attitude

Finally, there s always the issue of attitude. This problem comes from both sides of the aisle. But just as my overall attitude toward government regulation has changed over time, so has my knowledge of those involved in the process. By and large, and especially at higher levels of management, perceptions of obstructionist behavior seem to me to be signs of a professional commitment to the job. These folks truly believe that what they are doing, they do for the greater good. The challenge for management and the regulated community is to not perpetuate any existent "us versus them" mentality and to find better ways of doing things. Many times, the government folks themselves have great ideas that will decrease the burden on providers and services while still maintaining quality and safety standards. They look to have these ideas facilitated into reality. Unfortunately, the adversarial mindset kicks in far too often on both sides, and progress grinds to a halt.

I m far from saying that everyone involved in the regulatory process is a Pollyanna in disguise. Some people wield that inspector s badge like a club, and they do so to the detriment of the entire process. Even I ve been known to go into a restaurant and grumble under my breath that an inspection in imminent when the service is bad. (Never actually did it, and never will, unless I get food poisoning. There s also no truth to the rumor that when I get mad at people, I holler NO BIRD FLU VACCINE FOR YOU! in true Soup Nazi style). But, the majority of the time the regulatory process does the right thing, which is to help others do the right thing.

There s one other thing I want to mention about attitude. I think that where folks sometimes see rigidity and obstinance in regulatory programs and program staff, what they re actually seeing is passion. The staff members who run these programs, at long hours and low pay, do so out of a true belief that what they re doing is right and good. Their public and private flagellation only makes them dig in more, especially if those making the charges also have issues with compliance. Because these people want to do the right thing, they re surprisingly adaptable and forward-thinking. It s unfortunate that decreases in federals support of many regulatory programs in conjunction with increasing workload and the ability to respond quickly to problems precludes much of the long-term planning for change.

I d like to leave this discussion with one last challenge for you. I d like to propose that the regulated community is itself a regulator. This is not some kind of government "bait-and-switch" used to shift the problem. If you think about it, EMS regulates the prehospital care for a community. Local EMS ordinances and internal agency policies and protocols determine who can answer a 9-1-1 call, where the call for help is directed, who responds to the alert and to what degree the response occurs, what kind of care is delivered on scene, what is the appropriate patient disposition, and what supplies and materials are required to perform that response. Perhaps with a bit of introspection, you might find that those things you find difficult about outside regulators are those very processes you ve committed to within your own agency -- maintaining the safety of the community and insuring the optimal quality of care. Turns out that we re all in this together. Maybe that s our new philosophy.

Click here to read the first part of this discussion.




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