The entire country except So Carolina and Virginia have permits to practice sedation and/or general anesthesia. So Carolina is in the process of developing its permit which would leave Va the ONLY state that does not have a permitting system. If Virginia would at least talk with the other states and find out why they have decided to institute a permit, it would certainly be a plus for our state, and the public,  in knowing what practitioner, has what training. The reasons to have a permit system have already been hashed out by the other 48 states and it probably would be best if the Board did the inquires rather than I go into the reasons in this short comment session.

Secondly, the use of a "blue ribbon" panel of anesthesia experts to help the Board sift through the difficulties of investigating a morbidity or mortality HELPS the Board and the public both. California does it and although not perfect, it does help the Board get an indepth insite into the intricacies of some of these cases. Va has had 17 deaths since 1972 about one every two to three years and who knows how many reported or unreported morbidities.

The costs of developing an ad hoc blue ribbon panel would more than be offset by the fees generated by the permits issued and would help defray the costs of "targeted" office inspections that might be needed and experts' fees to review cases for the Board. 

Several years ago the status and issue of anesthesia, sedation, licensing, permits, etc. was brought before the Board of Dentistry and settled. There were individuals at that time who were proponents of making changes similar to Mr. Haddad, the personal injury attorney who is currently petitioning for changes to the regulations. The previous evaluation of similarly proposed  regulation changes proved such changes to be overly burdensome to dentists providing anesthesia/sedation services. It was also determined that the public interest was being served well by the status quo. Again, at that time there were self serving claims of numerous patient deaths at the hands of dentists using sedation/anesthesia, but like the current claims, there was no substantiating evidence, other than 2 or 3 cases over many decades and those cases were associated with oral surgeons, and one oral surgeon in particular.  A request for governing agencies to provide for public perusal, statements of basis, purpose, and substance, to consider any issue of proposed changes of the current regulations on sedation/anesthesia, would show the same results. No doubt such investigation would show little or no public benefit, and only again show that the cost benefit ratio for such rule changes would be onerous. Practicing dentists are struggling to pay ever increasing mandated taxes, fees, and financial levies mandated by state and local bureaucracies that are ever growing even in the current climate of recessionary depression. I propose we see proof demonstrating a verifiable public need for change, or leave well enough alone. We don't need to rehash this issue, and yoke small business with any additional burdens. R.S. Mayberry DDS

DRAFT:

Comments from VANA to Virginia Board of Dentistry

Elaine J. Yeatts

Agency Regulatory Coordinator

9960 Mayland Drive

Suite 300

Richmond, VA  23233

elaine.yeatts@dhp.virginia.gov

Dear Ms. Yeatts,

On behalf of the Virginia Association of Nurse Anesthetists (VANA), I would like to submit comments regarding a proposal to Amend 18 VAC 60-20, Regulations Governing the Practice of Dentistry and Dental Hygiene submitted by Robert J. Haddad and open for public comment until July 22, 2009.

This proposal is “To amend regulations to: 1) eliminate the distinction between conscious sedation and deep sedation since deep sedation is a likely result; 2) institute a permitting process with inspection of dental offices to ensure they are appropriately equipped to handle an emergency situation; and 3) create an Anesthesia Review Committee to assist the profession and the public with issues relating to anxiety/pain control/sedation in dentistry.”

VANA is the professional association representing Certified Registered Nurse Anesthetists (CRNAs) in Virginia.  As you are aware, CRNAs provide more than 65% of anesthesia care in Virginia, and in the United States, in all patient care settings, from hospitals to ambulatory surgery centers to office based practices.  The safety record of CRNAs and the importance of anesthesia care was recognized by the Board of Medicine in its regulations on Office Based Anesthesia (18 VAC85-20-310 through 390), in which personnel, equipment and procedural requirements were delineated for management of different levels of sedation and general anesthesia for procedures conducted in office settings.  The foundation of the Virginia’s legislature’s requirement for these regulations was concern over patient safety in physician office practice in Virginia.  These regulations required that sedation and/or general anesthesia in an office based practice could not be provided by the operating physician, and that the personnel providing this care had to be appropriately trained and licensed.  In this, the Board of Medicine diverged directly from current practice in dental offices.

VANA believes that, as the Board of Dentistry considers the petition submitted by Mr. Haddad, it carefully consider not whether different requirements for administration of conscious sedation vs. deep sedation are appropriate, and that a “permitting process with inspection of dental offices to ensure they are appropriately equipped to handle an emergency situation”, but, even more important, that regulations require that emergency situations can be avoided, whenever possible, by requiring appropriately trained and licensed personnel are required to be responsible for the administration of sedation and anesthesia, specifically other than the operating dentist.  Only when patients have the protection of knowledgable, skilled and appropriately licensed anesthesia personnel solely dedicated to their anesthesia care when they are undergoing procedures, can they be assured of the safest possible care.

VANA agrees with the petitioner that the Board should “create an Anesthesia Review Committee to assist the profession and the public with issues relating to anxiety/pain control/sedation in dentistry.” VANA stands ready to assist in elucidating the critical issues that will determine how to best assure the anesthesia safety of all patients in Virginia.

If we can be of assistance, please do not hesitate to contact me.

H.M. (Mike) Black, CRNA, President

I do not have a problem with the idea of development of an inspection and approval process for conscious sedation or creation of an anesthesia review committee.   Assuming both are intelligently developed by individuals with a background in anesthesia and sedation, they are good ideas and probably inevitable anyway.  Those who resist the notion might keep in mind that this will ultimately improve patient safety and possibly keep malpractice insurance rates and liability low. We might as well start working on this now while we have time, as opposed to resisting it until some sort of  knee-jerk reactive policy becomes necessary.  My one strenuous objection is the manner in which Mr. Haddad is presenting the petition to the Board, ie under the premise that conscious sedation is "likely" to lead to deep sedation.  I know of no studies, literature articles, or consensus statements to support this.  To preface the proposal with such a statement is irresponsibly inflammatory, and it makes me want to tell Mr. Haddad to go back, re-write the petition and resubmit it to the Board.  At the very least, the Board should go on record as rejecting such a rationale for development of an inspection process and review committee. 

I'm reading the petition to consider changes of the current sedation regulations and would ask that the parties that will be deciding this important matter to consider the implications of this petition carefully.  Thank you for reviewing my response.

First, Mr. Haddad's request to eliminate the distinction between conscious sedation and deep sedation "since deep sedation is a likely result" does not agree with the training I received, the research I have reviewed or the clinical experience of the dentists in my practice.  I would ask that the Board of Dentistry do a thorough review of the research to verify the truth of this claim by Mr. Haddad.  I am not sure it can be scientifically supported.  Additionally, my training and my specialty board define deep sedation as a category of conscious sedation, not a separate form of sedation.  Mr. Haddad appears to be comparing to a level of conscious sedation to conscious sedation, not a logical comparison.  A truer comparison would consider relatable categories; these are not since deep sedation is indeed a distinct level within conscious sedation. 

Second, I would be in favor of some sort of permit process as long as a large financial burden is not placed on the practitioner and this inspection process can be completed in a timely fashion, neither of which I am certain a bureacratic agency can guarantee.  I would hate to have to give up my ability to perform mild and moderate sedation to benefit so many pediatric patients in my area because I couldn't afford the cost of yet another license or renewal fee.  The costs associated with practicing dentistry already are high, particularly for a practice such as mine that accepts Medicaid.  Adding an additional fee makes it extremely difficult to justify the service, even though conscious sedation is greatly needed. 

Third, isn't the Board of Dentistry already tasked with assisting the profession and the public with issues relating to anxiety/pain control/sedation in dentistry?  The Board has published guidelines and requirements, they review cases related to these subjects and have access to qualified expert witnesses as needed.  What additional benefits would Mr. Haddad expect another committee to provide?

I would suggest that the Board rather than deleting the distinction between conscious sedation and deep sedation spend time more clearly defining the definitions of the varying levels of conscious sedation since conscious sedation has varying levels from mild to moderate to deep rather than eliminating the class of procedures currently defined as conscious sedation.  Deep sedation is a level of conscious sedation and needs to be considered within the confines of conscious sedation.  Deep sedation is currently placed alongside general anesthesia in the Virginia guidelines which is confusing to many people.  Conscious sedation by the AAPD guidelines is broken into 3 levels (minimal:  drug induced state in which patients respond normally to verbal commands, ventilatory and cardiovascular functions are unaffected; moderate:  drug induced depression of consciousness with the ability to maintain a patent airway, maintain purposeful response to stimulation and spontaneous ventilation is adequate;  deep: drug induced depression of consciousness during which patients cannot be easily aroused but respond purposefully after repeated verbal of painful stimulation, ability to maintain ventilatory function may be impaired and patient may require assistance in maintaining a patent airway).  If Virginia is going to allow practitioners to perform conscious sedation, then all 3 levels of sedation should be listed and considered within the criteria/requirements for conscious sedation and general anesthesia should be considered separately with its criteria/requirements (even if they are the same as general anesthesia) to reduce the confusion.  Something as simple as changing the title of section 18VAC60-20-120 from "Requirements to administer conscious sedation" to "Requirements to administer mild or moderate conscious sedation" along with the definitions that set a standard for this category would be most helpful.  Change the title of 18VAC60-20-110 from "Requirements to administer deep sedation/general anesthesia" to "requirements to adminster deep conscious sedation/general anesthesia" would keep these sections parallel in content and definition.  It would hopefully help reduce confusion as well.

I appreciate the opportunity to comment. 

DOCS Education supports reasonable oral sedation regulations that carefully and thoughtfully balance patient safety with access to care. Having a permit/inspection process and an anesthesia committee are certainly reasonable. Most state boards have anesthesia committees, and 39 of 50 states require conscious sedation permits (3 more will by next year). However, please keep in mind that the recession has stripped away the ability of most states to fund the manpower necessary to hold office inspections quickly AND the inspection process (in other states) was already slower than molasses in January anyway. We believe that a self-inspection by affidavit with the threat of random Board inspections is just as effective (CA, ID, WA, WI do this). However, if the board does adopt an inspection process, then we would recommend peer review by experienced oral sedation volunteer dentists (MD, ME, WV will be doing this). These options will preserve a healthy balance between patient safety and access to care.

As for eliminating the distinction between conscious sedation and deep sedation because deep sedation is a likely result, this is asinine and should be denied outright. While my fellow commentors and I may disagree as to the training that should be required for oral conscious sedation, I doubt any of them believe that the level of sedation known as "conscious sedation" doesn't exist in the spectrum of sedation. Otherwise, there would be a gap between anxiolysis and deep sedation such that a patient went straight from wide awake to practically unconscious without exhibiting the oxymoron we call "conscious sedation" along the way. No state has such an onerous regulation and none are considering it.

Thank you for your time and consideration.

Most states have implemented a ‘permit’ program and many also have a facility inspection requirement for anesthesia services provided to dental patients.  It is noteworthy that most states have set requirements similar to those in place in Virginia right now (albeit without a permit process).  It would seem prudent to determine to what degree patient safety is greater in those states versus Virginia, a state with similar requirements but without a certificate.  It may, also, be of interest to find out if access is in some amount reduced versus our state.  Safety trumps all else and if there is a measure of gain by having permits, or increasing the requirements needed to provide the various levels of service beyond what is now in place, we should all be for it.  Possibly, this is a place for the proposed “Anesthesia Review Committee” to start to work.  If we believe our current requirements for providing anesthesia services to dental patients are prudent, the objective is reached already. 

The same argument can be used for facility inspections.   If gains in safety can be demonstrated, and without placing onerous barriers to the services, we should proceed.  The proposed “Anesthesia Review Committee” will likely find from other state’s experience, that implementation of state wide inspections by qualified persons, timely and fairly done is a real challenge.  A challenge most states have not been able to meet.