In 2018, the regular cycle of NFPA 99 brings us the newest edition. Naturally, this will also trigger the ASSE Series 6000, Professional Qualifications Standard for Medical Gas Systems Personnel, into its new edition – a process that is underway as this is published.
Of course, the question is always “What’s new?” and “Does anybody need to care?” We could answer as we have always answered, with a recitation of the changes (a booklet detailing the changes is available) and a loyally snappy “of course you need to care,” which is really just a matter of form anyway. But in truth, the answer is a bit more complicated this cycle. There has been no change as such at NFPA (more on this later), but the general mood in the industry and among our clients has changed because of the actions of the Centers for Medicare and Medicaid Services (CMS). Two actions in particular are of great importance: First, in 2016, the CMS wrenched the whole industry from its moorings and moved from enforcing the 1999 edition of NFPA 99 to enforcing the 2012 edition. Second, the CMS updated their enforcement protocol with the introduction of their “K Tags,” which have even modified the point of departure for JCAHO and other accreditation bodies during their survey work.
A little more clarity: in moving from the 1999 to the 2012 edition, CMS crossed from one “generation” of the 99 document to its next “generation.” Connoisseurs of the document will recall that the 2002 edition represents the watershed rewrite, where it was entirely rewritten from the ground up to be easier to read and enforce. A lot of things that were in the 1999 edition became more obvious in the 2002. 1999 to 2012 is a three edition jump and, of course, every edition moved the document on. There are allowances in the 2012 edition that were explicitly prohibited in 1999, which can be challenging for a user comfortable in what they understood were the rules.
As an additional complication, while many engineers and facilities moved to newer editions by choice, compliance is not quite as relaxed. The K Tag system lists specific sections of the 2012 standard that facilities must consider. Because the accreditation bodies (JCAHO, DNS, CMS itself, or any other) now have first responsibility to evaluate these, this does crowd facilities on compliance. On top of this, CMS has made changes in other editions of standards, so facilities are dealing with a good deal besides medical gas at the moment.
Needless to say, all of this has diminished any enthusiasm for new editions of the standard, so the uptake on the 2015 and 2018 editions has been somewhat slow.
Inside the NFPA there is movement, also seen at other standards writing bodies, towards performance standards, which will have great influence on where the industry will go in the future. In the past, we might have described this as, “If it can do the job, you must permit it.” Such an oafish statement will never satisfy the cognoscenti of standards, so to describe it more elegantly, compare the prescriptive standard, which tells us exactly how a thing must be done, and the performance standard, which only tells us what must be accomplished, and perhaps how that might be evaluated. In all standards, the ideal is a performance requirement that will not restrict technology or ingenuity. A prescriptive requirement should only be applied when the risk is unacceptably high and only a proven method can be accepted, which in turn must be thoroughly described.
In the new NFPA, there are several examples of this. The most obvious is the new allowance for valves. In previous editions, a full port ball valve was prescribed for all medical gas valves. However, that was done in reaction to early use of gate and globe valves, which gave facilities a lot of trouble. But in fact, there is not a lot of magic in a ball valve. What is wanted is a field-serviceable valve with an indicating handle that does not restrict flow. In the 2015 edition, and even more in the 2018, the prescriptive ball valve requirement is gone in favor of a performance requirement stating all of this. Does that mean a ball valve can’t be used anymore? Of course not – they can meet the performance criteria and can therefore be used, but they are no longer the only technology that could be considered.
In the 2018 edition, several examples of this philosophy can be found. Pressure regulators and compressor and pump controls are two other places where the 99 moves from prescriptive to performance language, and there are others. It is this change that will unleash future developments in the industry and what makes the 2018 edition an important step forward.
However, changes like this are not always welcome in the user community. Many users like their standards nice and prescriptive because that makes life very easy – no thinking required. Performance standards put a premium on knowing what you’re doing and why. Evolution towards performance standards places a greater emphasis on being able to intelligently evaluate your options. In truth, the 99 has always been pretty disobliging about this and, as it evolves, things won’t get easier.
Here is where the ASSE Series 6000 standard fills in the education and qualifications that help underpin the 99. As the options open up in the 99, the work of the ASSE Series 6000 Working Group becomes an even more necessary complement that keeps the two effective.
The ASSE Series 6000 is now open and the working group is discussing the next edition, so it’s too early to know what will transpire or how the 6000 will change to adapt to the 2018 edition of NFPA 99. Watch this magazine – you’ll hear it about it here first.
Beyond that essentially philosophical evolution, there are some other interesting additions to the standard. The greatest impact will probably come from the introduction of mandatory vacuum filtration at the central plant. Surprisingly, this has been the “standard of care” in other major standards for decades, and only now has NFPA elected to go down the same road.
The change is not without controversy. NFPA held out for a very good reason, which is that there is not much evidence to prove that these filters do a great deal. It’s not the filters themselves – HEPA and ULPA filters are widely understood, proven, and accepted for the role. The question is whether there is much, if anything, for them to filter. There is no question that “bugs” are introduced into the system at the vacuum inlet. But then, between the desiccation inherent in a vacuum, the fact that in a vacuum there is little air pressure to move anything along the pipe, and the fact that the pipeline is built of that excellent bactericide copper, does anything viable really get all the way down the pump? There is no proof that it does, and none that proves that it does not either.
The academic argument is interesting, but maybe not really the issue. What do you think would be the reaction of the general public if they knew that unfiltered vacuum exhaust was being discharged into the wind off the hospital roof? How do you feel about it? Most people’s gut reaction is “ugh,” or maybe worse, and that is really the issue. After seeing the way the general public reacted to the few well-controlled Ebola cases that came to the U.S., it is clear that this is an extremely emotive issue. The wise thing is to be ahead of it. Being that a standard of care is already well established, it makes sense to employ it. In that way, the public health and the public mental health are both best served.
Also new in this edition are rules for applying oxygen concentrators as central oxygen sources in medical facilities. The technology for concentration is now very well understood and the number of installations around the world continues to grow. While concentrator use in the lower 48 tends to be restrained by economics, they are already in use there, and of course can be found in Hawaii and Alaska. Now that NFPA has clarified how to install them, they can be more readily applied and we can expect them to become more common.
The four classic indications that a concentrator may be a good idea are: remoteness, exposure to risk of interrupted deliveries, cost of the oxygen (whether in liquid or cylinder form), and the most interesting, the “urban island,” where there is simply nowhere to safely locate the bulk oxygen tank or to allow it to be filled. All of these exist in the U.S. and more so internationally, so the addition should be a useful one.
In the scale of NFPA 99’s history, the 2018 cycle can’t be called the most earth shaking, but the new document offers important options and new solutions, and deserves to be seen as a significant improvement to the standard.
