The council met to discuss the status of Neonatal Care Level rules, HB 2131 “Centers of Excellence,” and present the model for Maternal Levels of Care
Neonatal Designation Update
Jane Guerrero
- Health Services reviewed neo-natal rules on Sept. 10th, will be published in the Tex. Reg. Nov. 6th, followed by 30 day comment period, rules will be reviewed by HHSC on Feb. 2, 2016
- Steve Woerner asks when hospitals will be able to submit applications
- Not until rules are effective, levels which require surveys must submit survey results with application
- Allen Harrison asks after intent to not harm hospitals in designation, some hospitals will be functioning at lower levels until higher level designations are made
- Nothing in rule prevents hospitals from continuing to care for higher level infants
- Surveys will confirm that certain levels of care can be continued
- Dr. Speer comments that hospitals will not have designation until designation process has been decided upon
- Question as to whether current designations could be continued in interim or if designations could be pending
- Current designations are self-declared and rule does not allow this
- Not suggesting that hospitals self-designate, but that current designations be continued until deadline for survey results
- Dr. Toy comments that this is a complex issue and will be discussed later
Neonatal L2 Medical Director
- Rules allow for “board-certified” neonatologist or pediatrician, concern is that recent graduates with no substantive medical director training could fill these spots
- Dr. Toy proposes a strike of the “board-certified” language, leaving requirements in for experienced neonatologists or pediatricians
- Dr. Harvey comments that medical director training for recent students is not sufficient
- Dr. Cho concurs, wonders after rural facilities
- Dr. Briggs comments that experience qualification will allow rural facilities who do not have board-certified personal to maintain their programs, should cover all scenarios
HB 2131 – Legislative Update
Jane Guerrero
- Creates “Centers of Excellence for Fetal Diagnosis and Therapy,” directs PAC to have a subcommittee to discuss qualifications
- Bill provides guidelines for members, but does not recommend a specific number, Guerrero asks PAC to give recommendations as to composition
- Dr. Briggs comments that care is the highest priority and that PAC is designed to accommodate stakeholder concerns
Children’s Memorial Herman, Dr. Kenneth Moise
- Worked with bill authors to establish field guidelines
- Timely access to risk-appropriate care has been shown to reduce mortality and improve outcomes
- Centers would designate facilities with the best fetal care possible
- Dr. Saade comments that fetal care is a large field with many categories of care and bill does not address most of this
- Bill is meant to target the highest level of care
- Woerner asks how out-of-state referrals affect care and how facilities inform providers
- Out-of-state facilities are not good with follow-up care and it is important to inform patients of outcomes
- Harrison asks why this issue was taken to the state rather than being left to hospitals
- Patients should know where they can receive the best care
- Harrison asks why bill requires academic and research capabilities to receive designation
- Fetal care field is rapidly changing, academic and research facilities are best able to keep up with this
- Dr. Cho asks if there are existing legislative standards for fetal care
- No, Texas is the first state to look at this
- Dr. Saade comments that diagnosis should be split from therapy, therapy is often not needed
Texas Children’s
- Field has expanded and knowledge of outcomes is lacking, HB 2131 has the potential to address this
- Intent of the bill is to highlight the highest level of care
- Opportunity exists for Texas to lead
- Dr. Harvey comments that accelerated timeline puts this ahead of NICU and maternal care, most patients will not need fetal surgery
- The North American Fetal Therapy Network and International Fetal Medicine and Surgery Society
- Christina Stelly comments that nurse input would be very valuable
- Dr. Saade comments that subcommittee should have broad representation
UT Southwestern, Dr. Patricia Santiago
- Multidisciplinary expert care is the most important factor of excellent care for patients
- Holistic care should be the focus of the PAC
- Primary care providers should be included in care
- Harrison asks what the ultimate outcome of designation is? Is it a “badge” or a “funnel” for patients
- Should be a “badge,” hospitals should not be able to funnel patients and limit access to care
- Dr. Harvey asks after timeline
- Timeline should largely be left to PAC
- Would be ideal for centers to collaborate to with each other
- Dr. Harvey comments that is important to care for mothers and infants and then attach guidelines on fetal care
- Dr. Saade asks after opinion on PAC and subcommittee, how can you prevent “Centers” from stacking the subcommittee
- If the only people who are making the decisions are the ones who stand to benefit, situation is clearly unfair
- Woerner comments that this process will take time and asks if there is a plan amongst the “Centers” to develop standards
Dr. Alex Kenton
- Quality of care and outcome depends on resources available to patients
Dr. Sovani
- Care varies greatly from center to center
- HB 2131 gives possibility of care standards and opens door for more development
- Collaboration between high level care facilities and other facilities is vital
Dr. Briggs
- Subcommittee should have PAC members and interested consulting hospital members
- Stelly requests that a nurse be on the subcommittee
- Dr. Harvey suggest 7 members including nurse
- Dr. Saade comments it is important to have wide range of opinions
- Dr. Cho highlights importance of input from stakeholders
- Dr. Hollier wonders where standards will come from
- Dr. Sovani suggest amendment that allows for an extended timeline
- Dr. Toy asks when recommendation needs to come from this committee
- Jan. to Feb. of 2016
- Dr. Toy comments that PAC might need two plans, one that allows for extended timelines and one that works with timeline as planned
- Dr. Briggs moved to establish a subcommittee to determine numbers and recommendations for HB 2131 subcommittee, Dr. Cho to chair
- Dr. Sovani recommends Centers each have more than one member on the subcommittee
- Dr. Saade asks for clarification on member make-up from HB 2131
- Dr. Toy comments that Dr. Cho’s subcommittee will look at this
- Subcommittee to investigate and advise on formation of HB 2131 subcommittee membership: Dr. Cho (Chair), Dr. Saade, Woerner, 3 Center consultants, Stelly
Maternal Levels of Care
https://www.hhsc.state.tx.us/news/meetings/2015/pac/6.pdf
- Dr. Toy Presents the Obstetric Care Consensus document, which includes discussion of care and model Levels
- Dr. Speer comments that OB care has long been established and subject to standards
- Dr. Toy comments that this must be a good system for all patients and hospitals
- Levels should provide for risk-appropriate transportation, very low-weight babies should be born at appropriate facilities
- Dr. Toy comments that Levels must look not just at volume, but at quality as well, each hospital should have the ability to transfer based upon need, US is currently 60th in the world for maternal mortality
Birthing Centers
- Dr. Harvey comments on water birth and the fact that they require IRB protocols, most of these happen at birthing centers
- Stelly comments that these are occurring, wonders if including references would be wise
- Dr. Toy comments that PAC cannot recommend things regarding water births or birthing centers, but can raise the issue with appropriate regulatory authority
- Dr. Saade suggests that designation levels include “evidence-based practices” requirement, Dr. Speer suggest molding this into the rules
Level I
- Dr. Toy comments that transfer is very important
- Dr. Cho brings up lactation
- Dr. Toy comments listing is not all-inclusive
- Harrison wonders what feedback has been reviewed from TORCH
- Dr. Toy comments that Sheffield authored bill which allowed for extension on rulemaking decision
- PAC is engaged directly with TORCH and rural facilities
- Stelly comments that transfusion regulations would be helpful
- Dr. Sovani implores PAC to link neonatal and maternal care levels
- Dr. Toy responds HB 15 allows only a one level difference of care in facilities
Level II
- Dr. Toy comments that “ideally” language present in model designation must be changed to more concrete terms
- Stelly comments that examples and evidence would be helpful to incorporate special equipment for obese patients
- Dr. Briggs responds evidence exists
- Dr. Speer asks if joint committee regulations have been implemented
- Stelly answers no
Level III
- Dr. Sovani highlights the importance of blood bank support and blood product availability
- Dr. Saade mentions that transfusion support is included in Level I
- Fetal anomaly support is highlighted
- Stelly raises concern for in-transport care for patients, transport generally does not have standards of care support
- Dr. Harvey comments that the PAC does not want to “reinvent the wheel” and include duplicate language between neonatal care and maternal care, but coordination language is important
- Dr. Cho agrees, transfer and coordination language should be wrapped into the basic Levels of care
- Dr. Sovani suggests that transfer care should be described in hospital program plans
- Dr. Saade comments that on-site care was preferred generally as off-site consultation is less effective in emergency situations and that Levels are designed to accommodate all patients including emergencies
- Dr. Speer asks after emergency C-section language
- Dr. Toy responds that all hospitals should have this capability regardless of designation
- Dr. Hollier points to C-section language in Level I
Level IV
- Harrison asks for clarification of difference in Level III and Level IV ICU care
- Level IV must have obstetric service comfortable with managing critical care, basically a collaboration requirement and is designed to care for extremely fragile patients
Public Comment
Dr. Kenton
- This is an opportunity to improve outcomes and would be good to have something in levels that networks with diverse care
Dr. Sovani
- Important to have robust data to define outcomes
- Perhaps a joint maternal and neonatal database could be prepared and utilized
- Dr. Toy comments that this was requested, but fiscal note stalled the project
Dr. Robert Watson, Baylor, Scott, and White Health
- Wants clarity over availability “at all times” language
- Harrison comments that this was specifically left a little vague, “at all times” does not imply “on-site”
Dr. Briggs
- Would like language including “delivering family physicians” to appropriate care providers going forward
- Dr. Hollier comments that obstetrician requirements are an “and” not an “or”
Dr. Toy
- Having care regions defined under Trauma regions will not lead to mandates on care and operations
- Maternal rules presented are only a “starting point”
Next meeting on November 17