MCHB/EPI Miami Conference — December 7 - 9, 2005

Toward Improving the Outcome of Pregnancy — Transcript

LILLIAN BLACKMON: Thank you, George, for setting the thoughts for what I'm going to be talking about. First, I want to express my thanks to Dr. Barfield for asking me to come and present this information and some of what I'm going to talk about has some overlap with what you have just heard. I'm going to speak on an effort to try to define or to collate and evaluate existing regulatory language in states around the country relative to neonatal levels of care and you've heard about TIOP One and the work that they did and they had three named and defined levels of care. Interestingly enough there is not a great deal of detail in the language of the actual kinds of problems that they anticipated would be appropriate to each of the levels of care. Level one was normal newborn care and included the ability to handle the sick infants, stabilize and transfer but really didn't provide for any illness care at level one. Level two was at the first point where illness care was mentioned and in TIOP One it basically suggests that not ventilatory support would occur there beyond initial bag and mask respiration and then in level three just illness care at the highest level. And I am going to speak only to neonatal aspects of this, though. It really was a parinatal in their obstetric components but my charge is to deal with the neonatal part and TIOP Two took it a bit further but they revised the terminology and I bring this out because it did have an impact of what was found when we looked at what's happening at state levels and instead of level one it was basic. Level two was considered specialty and level three sub specialty and the expansion that occurred with that talked a bit more about personal capabilities and credentials and talked a bit more about the kinds of infants who could be cared for at those levels.

Then George has mentioned guidelines for parinatal care and guidelines one and two came out after TIOP One and they used TIOP One terminology. I would challenge you a bit in that I think guidelines did become a bit more specific as time went on but did have their shortcomings. In guidelines three and four the TIOP One terminology changed to TIOP Two in '93 and their units were named. That is, individual hospital functional units were named and specifications were given but if you look carefully the units are not tied to the levels. The discussion of levels was broad. General discussions and units got into more specific so there was nothing that said you couldn't have a NICU at a level two, for example, in guidelines.

Guidelines for parinatal care fifth edition that came in 2002 added two things. It did mention units in free standing children's hospitals because in many areas of the country that was where the concentration of pediatric expertise, particularly sub specialties of pediatric surgery and the other point was to bring out that there were obviously circumstances where level three units did not serve as regional parinatal care centers and so there was specific language about what distinguished center in terms of being a regional center and having responsibilities for outreach education, transport, data collection, et cetera.

The AAP section on parinatal pediatrics which is the group in the academy that are basically neonatologists but anyone who wants to consider himself as a specialty interest in parinatology can be a member of that section began to try to do some quantification of what is available in the country. The first directory of neonatologists came out in 1997. It was just (inaudible) neonatologist, the big effort in 1998 was to add in a listing of the neonatal intensive care units in the country and the process that was followed to do that was to ask the neonatologist where they worked and so the numbers of neonatal intensive care units then came to be devolved from that report.

In 1998 I was involved in the task force work group within NCHS and the updating of the standard certificates for birth, fetal death and death and in that I was asked to come up with a definition for a neonatal intensive care unit and when I went to look for that there was no standardized definition anywhere around. I went to the section. I went to the committee on fetus and newborn of which I was then a member and we got some consensus though not unanimity in saying that it was a unit with a capacity for providing full life support for more than 24 hours and out of that became a big push to try to find out how units identified themselves around the country.

The Vermont Oxford Network that George mentioned has a sub categorization of neonatal intensive care unites based upon the birth weights and gestational ages of babies admitted. The ventilatory support capabilities, the presence of pediatric surgeons and the presence of the ability to do ECMO and that was how they were sub categorizing their information. After the first attempt which was just to ask the directors of units to write back and tell us what they considered themselves we had almost all level three circumstances but those of us who knew what was going on in our individual states and who were looking at this data said this can't be correct because we know, you know, place X does not have the capability to do this. They shouldn't be considering themselves a level three, et cetera. So a formal survey was done in 2002 and used categorizations that were based somewhat on the Vermont Oxford sub categories and out of that some 880 NICU's were identified in the country and of those about two-thirds would have been what were considered level three. I'm going to have to speed along here.

The committee on fetus in newborn in about 2001 became very interested in trying to develop some language that could be applied uniformly and our final statement on this was published in 2004. You see there level one is normal newborn care. We subdivided level two based upon the ability to provide ventilatory support to larger preterm infants and subdivided levels three between progressively smaller infants, the ability to do pediatric surgery and particularly cardiac surgery and ECMO or extra (inaudible) oxygenation for those of you who are not into our jargon. In that effort we tried to find out what was going on around the country, what other efforts have been made to come up with uniform definitions and there have been two previous reviews on this. Donna Straveno and others from John's Hopkins and a HRSA grant evaluated this in 11 states. They did a structured interview with MCH staff usually the director and found again wide variation in how units identified themselves and then Ellen Schafer under contract to March of Dimes did a review in 2001. In her review she had information on only 40 states. Hers was a formal questionnaire sent to the MCH and then some follow up in getting information on other sources. So some of us set out to do a study to try to get information from all 50 states and particularly to get operational status on what regulatory mechanisms there were about applying the various standards or definitions. The data collection started out with (inaudible) from the section requesting from resident neonatologists in each state to send him a copy of whatever state regulations applied. We thought those people who were functioning in the state ought to know what they were being asked to comply with. We did not get 100 percent response on that, so we next sent a request to the state health departments of various states and here I think our survey went a bit awry because it did not always go to the maternal child health component of the health department but again we still did not get a complete reporting. And so I embarked on a systematic search of state government web sites for the regulatory documents. I can tell you that is was on average about ten hours per state in order to be sure that I had exhausted the possibilities of finding information there and if I didn't find it I then tried to contact an appropriate person in the state who could tell me where I could find it. The data that was collected was the terminology that was used, what functional criteria that is population differentiation and what care capabilities differentiated the various levels, utilization criteria and I'll show you details on that, what mechanisms of compliance enforcement were in place and the specific source citation in controlling state agency. The criteria that we used for whether there was a defined level of service required designation as a service, not as a unit or physical space and a description of graduated complexity of care requirement or an intensity of care capability. Now, in other words the regs couldn't say just that we have a normal nursery and intensive care nursery. They had to say much more than that. Thirty-two states have defined levels of hospital newborn services that I could locate. Seven states had named units or physical facility descriptions and 11 states had neither and if you look at the little state map that I have up in the corner of each of these slides the red states have defined levels, the yellow states are those states with named units or physical facilities and the purple states are those with neither. Nineteen states do this through hospital licensure. Twenty states I found it in at least one source and in 12 states in two or more sources, certificate of need for construction, expansion and renovation are specifics within the state health plan where another source and that is a mechanism used in ten states. In 19 states either through the state health department or some equivalent agency, it's not called a health department in every state, or an affiliate program that has some connection with the state health department or equivalent agency account for 19 and then the next one shows the breakdown and the overlap. If you will read from left to right licensure covers up through all sources then the CONSHP you can see where they fall in and finally those that are state health department and affiliates. So there's tremendous overlap and as noted in four states all sources had information there. The numbers of designations varied from two to six and those that had four or more generally the highest level was the regional parinatal care center and I want to just flip through these next ones. The lowest level there were 18 different terms that were used.

There was some stratification that is more than one level of normal newborn care with limited illness care. Then the mid levels 19 different terms used some with stratification and here we begin to see some language about illness care. Higher levels of these would be in the states that had more than three levels. Fewer designations, beginning appearance (inaudible) who had multiple stratifications. I have one state written on these two slides but it's incorrect. There's more than one and then finally the highest level where we see the words of parinatal center, regional or comprehensive or (inaudible) unit and at the highest level obviously there would be no stratification and here language included information about regional responsibilities. In functional criteria 16 states listed birth weight or gestational age.

There was a trend for the highest level of care to be designated for the smallest infants. The limit was most frequently stated for the mid level of services and it spoke to mechanical ventilation either non-beyond initial stabilization, a maximum hour limit or a lowest birth weight limit for ventilatory support. Four states had supplemental oxygen limits and in some states I think five states included language limiting cardiac surgery and eight states limiting where pediatric surgery is done.

Interestingly and this is a very hot topic for people who are doing work in this are about the importance of volume or size in terms of outcome and utilization criteria were in the language of 18 states. The minimum number of intensive care beds ranged from six to 25 and the breakdown whether they talked about capacity by unit or by live birth in an area the volume as in service deliveries or live births within a region discharges or ventilatory days per year, occupancy either as percent beds occupied or average daily census and then (inaudible) of case mix. The compliance enforcement varied obviously by the source from where we found the information. In 26 states use one or more options to regulate parinatal services either licensure, approval for expansion, renovation or construction that has a limitation that it occurs only at the time that that particular event takes place and then funding mechanisms. If I can just finish the last thought on this. There were eight states that allowed self-designation within their regulations or language but in two of those states there had to be review and approval but that was a paper work type review. Nineteen states had language that allowed for onsite inspection. That is implied in all licensing but in many states licensing occurs for the hospital in toto and onsite inspection occurs only if there is a complaint that requires investigation.

Lastly, in terms of funding linkage I found information from 11 states. I do not offer that as being conclusive because it was virtually impossible to track down whether or not Medicaid funding was tied to levels in most states. It's very difficult to get into Medicaid regulations via the Internet. Thank you.