Florida Hospice & Palliative Care Association



DEPARTMENT OF HEALTH

FLORIDA BOARD OF NURSING MEETING

Radisson WorldGate Resort

3011 Maingate Lane

Kissimmee, Florida 32301

Friday, October 9, 2009

In re: Rules Hearing on 64B9-8.005

BOARD MEMBERS:

DR. JESSIE COLIN, R.N. Chairman

MARY JANE HERRERA, L.P.N.

RITA MUNOZ, LPN Member

LAVIGNE ANN KIRKPATRICK, R.N. (Not present)

MARIA KOLB, L.P.N.

BARBARA KEMP, Consumer Member

STEPHEN BOWEN, Consumer Member

DULCE CUETARA, R.N. (Not present)

DR. JOHN McDONOUGH, CRNA Member

DR. LINDA HORTON, RN Member

DR. ANN-LYNN DENKER, ARNP Member

DR. JODY NEWMAN, Consumer Member

STAFF PRESENT:

RICK GARCIA, M.S., R.N., C.C.M., Executive Director

TERRI SUE ALDRIDGE-RUSSELL, Operations Analyst II

WILLIAM SPOONER

VIKIE BOYD

EDUCATION COMMITTEE PRESENT:

PATRICIA SEABROOK, Director of Education

ERIN PIERCE

MICHELLE YOUNG

KATHY G. WHEELER

SHERRY SUTTON-JOHNSON

MARY BETH VICKERS

ATTORNEY GENERAL’S OFFICE:

LEE ANN GUSTAFSON, ESQUIRE, Board Counsel

RACHAEL CLARK, ESQUIRE, Board Counsel

PROSECUTION SERVICES:

WILLIAM MILLER, ESQUIRE, Prosecution Services

MEGAN BLANCHO, ESQUIRE, Prosecution Services

WALTER WIDENER, ESQUIRE, Prosecution Services

ANNIE POWELL, Staff

(Whereupon, the meeting was called to order

by the Chair, after which the following occurred:)

DR. COLIN: Good morning, everyone. My name is Jesse Colin and I serve as Chair of the Board of Nursing, and I’m from Fort Lauderdale. I’d like members from the Board to please introduce themselves, starting on my left.

DR. HORTON: Dr. Linda Horton, RN member, Lakeland, Florida.

DR. NEWMAN: Dr. Jodie Newman, consumer member, Clermont, Florida.

MR. BOWEN: Steve Bowen, consumer member, Tallahassee, Florida.

DR. DENKER: Dr. Ann-Lynn Denker, Miami.

DR. McDONOUGH: Dr. John McDonough, Jacksonville.

MS. HERRERA: Good morning. Mary Jane Herrera, LPN member, from the LaBelle Fort Myers area.

MS. KOLB: Good morning. Maria Kolb from Jacksonville, LPN member.

MS. KEMP: Good morning. Barbara Kemp, Tallahassee, Florida, consumer member.

MS. MUNOZ: Good morning. Rita Munoz, LPN member, Fort Myers.

DR. COLIN: Staff?

MS. SEABROOK: Patricia Seabrook, Director of the Education Unit, Board staff.

MR. GARCIA: Good morning. My name is Rick Garcia. I’m the Executive Director of the Florida Board of Nursing, and I would request that if you have anything with an on or off switch, if you could take it out of your coat pocket, purse, or brief case and set it to ‘silent’ or ‘stun’. Thank you and welcome.

MR. SPOONER: William Spooner, Board staff.

MS. RUSSELL: Terri Sue Aldridge Russell, Board staff.

MS. BOYD: Good morning, Vickie Boyd, Board staff.

A VOICE: (Inaudible, off microphone.)

DR. COLIN: You need to speak into the microphone. It’s not on. I’ll go to IPN for the time being.

Oh, that’s not on, either.

MS. WHEELER: Kathy Wheeler, nursing education consultant.

MS. SUTTON-JOHNSON: Sherry Sutton-Johnson, nursing education consultant.

MS. VICKERS: Mary Beth Vickers, nursing education consultant.

MS. PIERCE: Erin Pierce, nursing education consultant.

DR. COLIN: IPN?

MS. DUPREE: I’m Jean Dupree and IPN is the Intervention Project for Nurses. We were established as a result of legislation passed in 1983 and have two major roles. One, as you will hear today, is to assist the Board of Nursing in protecting Florida citizens from any nurse or CNA whose practice may be impaired as a result of alcohol and drugs, mental health issues, or physical health issues; and two, to assist nurses and CNA’s in obtaining treatment and rehabilitation.

If you are referred here today, please come to our table for more information. Thank you, Madam Chair.

DR. COLIN: Department?

MR. MILLER: William Miller, attorney with the Department of Health Prosecution Services.

MR. WIDENER: Walter Widener, Prosecution Services Unit.

MS. BLANCHO: Megan Blancho, attorney with the Department of Health.

MS. POWELL: Annie Powell, Department of Health staff.

DR. COLIN: We also have an officer from this area. If you would please introduce yourself?

DEPUTY BRYANT: Deputy Marcus Bryant, Osceola County Sheriff’s Office.

DR. COLIN: Thank you. Let’s stand for the Pledge of Allegiance.

(Whereupon, the Pledge of Allegiance was recited.)

DR. COLIN: This morning we’re going to be starting with the rule hearings, and the first one is on unprofessional conduct. I’m going to call on Ms. Gustafson.

MS. GUSTAFSON: You’ve had several requests for a public hearing on the amendments to Rule 8.005 with regard to the administration of conscious sedation and the standards of practice for RN’s who are doing that, and you need to have the public input from the people who have requested the hearing, and anyone else here who wants to comment on the rule.

You’ve also received in your packages a letter from the Joint Administrative Procedures Committee attorney, Marjorie Holiday. It’s rather lengthy. It was written on September 15th and it’s here at this time for your information. I’ll be working on a response to it and I will bring that back to the December meeting before I send it to Ms. Holiday. Since it’s a lot of substantive issues, I want to make sure that I’ve got your input and I’m telling her the correct thing. So that’s for your information; and if any of the Board members want to provide me any information with regard to that letter in between times, you can call me. Just don’t talk to each other about it.

The first requester is the Florida Society of Oral and Maxillofacial Surgeons. It is 32731. Is there a representative here from that organization? Okay. Come on up.

WHEREUPON,

LANNY GARVER, M.D.,

a witness herein, after having been first duly sworn to tell the truth, was examined and testified as follows, to-wit:

DR. GARVER: Good morning. I’m Dr. Lanny Garver, a practicing oral and maxillofacial surgeon from the greater Fort Lauderdale area, and sitting next to me is Mike Huey, our counsel.

I represent the Florida Society of Oral and Maxillofacial Surgeons and our 230-plus members. We appreciate that it is not within the purview of the Florida Board of Nursing to have any particular interest in other professional boards under the direction of the Division of Medical Quality Assurance. However, we hope that an understanding of the Board of Dentistry’s rules governing the administration of deep sedation and general anesthesia will help to clarify the duties of the registered nurse in the oral and maxillofacial surgery office where anesthesia is administered and convince the Board of Nursing that these duties are within the scope of the practice of the registered nurse and do not constitute unprofessional conduct.

Under the rules of Florida Board of Dentistry, only a dentist who has completed a minimum of one year of advanced training in anesthesiology or an oral and maxillofacial surgeon is eligible to apply for a permit to administer general anesthesia. I might add that the use of IV sedation general anesthesia is not granted by the presence of a license in the state of Florida but rather the permit, which is an additional accomplishment and obtained by proof of training.

This eligibility is based on the OMS education and training, which includes a distinct and specific curriculum in anesthesia, clinical medicine, and surgery, a minimum of four to six months rotation on the anesthesia service where the OMS resident functions at the level of the anesthesia resident with a commensurate level of responsibility and a longitudinal and progressive experience in the administration of outpatient deep sedation and general anesthesia in the oral surgery clinics of that hospital throughout the four year hospital-based residency.

In the oral and maxillofacial surgery office, it is the oral and maxillofacial surgeon who administers the anesthetic and is responsible for the assessment and care of the patient, the adequacy of the office, the equipment and drugs and the competency of the team to assist during administration of anesthetics and performance of the surgical procedure. These offices have to be examined and reviewed before they’re granted their permit, and have to be re-examined every five years in order to maintain their permit, and I might add in order to maintain membership in our parent organization, the American Association of Oral and Maxillofacial Surgeons.

Our members are advanced cardiac life support, ACLS, certified every two years, maintain basic life support, and all of the assistants have basic life support.

The role of the registered nurse in such cases as I’ve described to assist the oral and maxillofacial surgeon, which assistance may include the injection of a pre-determined anesthetic dosage under the oral and maxillofacial surgeon’s direct instruction and supervision, is the role of the registered nurse including helping monitoring the patient. The Florida Society of Oral and Maxillofacial Surgeons supports the delivery of surgical and anesthesia services at the highest possible level and urges the Board of Nursing not to diminish the ability of registered nurses to continue to assist oral and maxillofacial surgeons in the delivery of quality based surgical procedures, or to consequently decrease employment opportunities for registered nurses.

This synergy between the quality training and experience of the registered nurses and the oral and maxillofacial surgeon has worked well over the years, and there is no convincing or compelling evidence that there has been any detrimental effects on the health of the citizens of Florida. Quite the contrary, it has been proven to be safe, convenient, and a cost-effective technique.

Thank you very much and I would introduce Mike Huey who wants to give additional testimony.

MR. HUEY: Madam Chair, my name is Mike Huey. I’m an attorney in Tallahassee, Florida, with the firm of Gray Robinson.

DR. COLIN: You may want to pull the mic a little closer to you.

MR. HUEY: Okay. Is that better?

DR. COLIN: Yes.

MR. HUEY: I just wanted to point out a couple of things and I think you’re going to have plenty of testimony from more lawyers than you want to hear from this morning probably.

I would tell you as is pointed out in the letter from the Joint Administrative Procedures Committee, I do believe that the rule runs head long into conflict with existing statutes, not the least of which is your own statute, but also with the Medical Practice Act, the Osteopathic Medical Practice Act, and the –

MS. GUSTAFSON: Excuse me, sir. You need to speak directly into the microphone. It’s difficult for the Board to understand if you’re not speaking directly into the microphone.

MR. HUEY: I apologize for that. Is that better?

MS. GUSTAFSON: Yes.

MR. HUEY: I think it does run into conflict with existing statutes in the Medical Practice Act and certainly runs into conflict with regard to the dental practice team as authorized under the Dental Practice Act. I think the other comments we would just echo and urge you to read carefully the comments that were provided by the Joint Administrative Procedures Committee. We believe not only is their conflict in the statute, but we believe that there’s also many violations of Chapter 120 in terms of the vagueness and ambiguity in the rule as currently presented. We applaud all of you on trying to make sure that medicine and nursing is delivered safely. There are certain legal requirements required when you develop these rules. We don’t think this rule meets those requirements as required under 120. We would urge you to reconsider this rule very carefully and certainly would urge you on behalf of the Oral and Maxillofacial Surgeons not to do anything to upset the existing highly successful dental team approach in the oral and maxillofacial surgery offices and in the dental offices. I’ll be glad to answer any questions.

DR. COLIN: Board members, do you have any questions?

(No response.)

DR. COLIN: Thank you. Oh, Dr. McDonough?

DR. McDONOUGH: Is it your contention that the Board of Dentistry somehow is empowered to delineate standards of practice for registered nurse licensees in Florida?

MR. HUEY: No, sir. It is not. That was not the point that was made. I think the point that was made was the conflict that starts running into when you start dealing with the utilization of personnel, which is also spoken to in the medical and dental practice acts, and trying to ferret out that conflict I’m not suggesting that we can dictate the practice model for nursing. I am suggesting that when people are operating under the direct supervision of a medical practitioner that you start running into a conflict between what the legislative statutes provide.

DR. McDONOUGH: Thank you.

DR. COLIN: Any other questions from Board members? Okay. Thank you.

MS. GUSTAFSON: Next on your disk is the request from the Florida Gastroenterological Society. 32733 is a letter from attorney Christopher Newland.

WHEREUPON,

PHILLIP STEIN, M.D.,

a witness herein, after having been first duly sworn to tell the truth, was examined and testified as follows, to-wit:

MR. NEWLAND: Good morning. On behalf of the Florida Gastroenterological Society, my name is Chris Newland. I’m the attorney for the organization. The FGS supports the Board’s efforts to improve safety and is in full support of most of this rule, including training requirements, but does have a few reservations mostly related to the explicit references to Propofol which as Dr. Stein on my left will tell you is probably the preferred drug for colonoscopies to achieve conscious sedation.

The GI’s have always supported the Board of Medicine’s approach to defining levels of surgery not based upon the drug used but by the level of sedation achieved. Even with the best of intentions, it appears the Board of Nursing here is creating some sort of conflict with office surgery rule and medical statutes, much like Mr. Huey said just a few moments ago.

Secondly, I want to address the potential enormous economic impact that this rule would have. Managed care companies have put GI’s on notice that they will not pay for anesthesia providers for colonoscopies. Therefore, implementation of this rule would force GI’s to either pass the cost of anesthesia care directly to the patient or to take the money out of their own pocket. This would have a significant impact on these physician practices, which qualify as small businesses, especially those that perform colonoscopies. To the best of our knowledge, no statement of estimated regulatory cost has yet been prepared that addresses this concern.

Finally, we ask if the rule is even necessary. According to the Board of Medicine’s Office Surgery or Office Statistics, there have been no reports of Propofol related adverse incidents in GI offices for at least seven years, meaning that this rule may not even be necessary. With all that being said, the FGS is in full support of high safety standards; however, standards that increase costs and decrease the accessibility to quality health care such as colonoscopies should be carefully considered before they’re enacted.

With that, I’d like to defer to Dr. Stein, a GI at Florida Hospital, to address the medical issues.

DR. STEIN: Good morning. Thank you for the opportunity to speak to the Board this morning. My name is Dr. Phillip Stein; I’m a gastroenterologist. I’ve been practicing GI for 30 years. I’m board certified in internal medicine and gastroenterology. I’m on two medical school faculties. I’m the medical director of digestive health for Florida Hospital’s 2,100-bed system with seven endoscopy units. Unless there’s another gastroenterologist in the room or an endoscopy nurse, I would say that I have done more moderate sedation than anybody in the room, including any anesthesiologists. Over the years, doing procedural sedation we’ve seen a number of changes. There have been a number of changes in monitoring. There have been a number of changes in medications.

The drugs which we regularly use nowadays for procedural endoscopy, including Versed and Fentanyl, can produce any level of sedation that’s desired, including minor, moderate, and deep sedation. So separating out Propofol specifically as the drug that’s meant for deep sedation I don’t think is appropriate. Propofol can be used for all those different levels of sedation. Propofol has many uses and has been used in many ways around the US and around the world. There are many places in the United States where Propofol is regularly administered by nurses. It has a very high satisfaction rate with both physicians and patients, and there is at least one study that shows Propofol sedated colonoscopy has a more accurate outcome.

I respectfully suggest that the Board of Medicine – the Board of Nursing, I’m sorry, the Board of Nursing not get into a turf battle between physicians about who should use Propofol. I think trying to regulate specific medications is not the way to go in terms of safety. Level of sedation is what should be appropriately addressed.

DR. COLIN: Board members, do you have any questions?

DR. McDONOUGH: Is it the contention of the witnesses that the administration of Propofol to induce sedation by registered nurses is an appropriate practice?

MR. NEWLAND: I think that the administration of Propofol at the direction of a physician where the nurse is the one who is actually pushing the medicine, giving the medicine intravenously is appropriate, yes.

DR. McDONOUGH: Are you aware that there’s a declaratory statement that’s years and years old issued by the Board of Nursing stating that that is not appropriate practice for a registered nurse?

MR. NEWLAND: I am not aware of that, no.

DR. McDONOUGH: There is. I guess the point I would make is the practice that you’re describing is already clearly prohibited by declaratory ruling of this Board and it’s been standing for years.

DR. COLIN: Any other comments from Board members?

I just want to remind everyone this issue is really about nursing practice and what the Board of Nursing sees in terms of the regulation of professional practice by registered nurses.

Any other comments?

(No response.)

DR. COLIN: Thank you.

MS. GUSTAFSON: The next on the agenda is a letter from Ethicon Endo-Surgery, Inc.

DR. COLIN: That letter is on page 32736.

MS. HANSEN: Good morning, Madam Chairman. My name is Wendy Hansen. I’m an attorney in Tallahassee, Florida, and with me today is Marcia McKenna. We’re today on behalf of Ethicon Endo-Surgery, which is a Johnson & Johnson company.

We’ve been before this Board multiple times through your advisory committee. We participated in the prior rule making that this Board undertook many years ago. We participated in your rule development workshop, so you’ve heard a lot from us. So I’m not going to re-address those points, those specific points about the technology, but I just want to make a few comments and then I have some written comments to share with you.

Ethicon Endo-Surgery has developed a computerized assisted personalized sedation system, which is known as the SEDASYS System, for the administration of Propofol by a registered nurse under the supervision of a physician for the purpose of mild to moderate sedation. When FDA approved, the SEDASYS System will be an on-label alternative to provide a safe and effective way for physician-RN teams to sedate patients undergoing the cancer screening procedures, such as colonoscopy and upper endoscopy. Using Propofol, as you’ve heard, is the preferred sedative of most physicians.

You have heard testimony from four of our expert witnesses that have come before you at various points: Dr. Kai Matthes, who is a gastroenterologist as well as an anesthesiologist from the Harvard Medical School, Keith Denning who is a CRNA, Marsha McKenna who is here with us today, as well as Cindy Westmoreland who was involved in the pivotal and clinical studies that were done.

A common barrier that we’ve found for increasing patient compliance with colorectal cancer screening is the fear of pain and the unpleasant experience. Approximately half of all patients who receive a referral for a colonoscopy do not follow through with the doctor’s order to obtain that particular procedure. Our clinical data as previous submitted to this Board demonstrates a high satisfaction for both clinicians and patients when sedated with the SEDASYS System for colonoscopy and the EGD procedures. This proposed rule language prohibiting the administration of Propofol by non-anesthetists for moderate sedation would limit the scope of practice for Florida physician-RN teams that the FDA panel would view as safe and effective, thereby eliminating one of the alternatives to treatment of care.

The proposed rule as you’ve heard from Mr. Huey we believe exceeds the delegated legislative authority of this Board by narrowing the legislatively determined scope or practice for a professional nurse. We don’t believe that there is any evidence that has been presented at the Advisory Committee or at any of your rule development workshops that would support this particular rule.

The FDA panel’s recommendation, their labeling, which is designed specifically to enable physician-RN teams to administer Propofol with the SEDASYS System would be in contradiction to this Florida Board of Nursing rule. We believe the proposed rule fails to recognize the FDA’s role in determining the safety and efficacy of the SEDASYS System, the potential cost savings to be achieved by the health care system in the State of Florida through the use of this state of the art emergent technology and the resultant expansion of colonoscopy and upper endoscopy procedures for cancer detection, colorectal cancer screening rates remain well below the American Cancer Society’s goal of 2015 for seventy-five percent of the eligible population.

Specifically, the Propofol labeling states that it is an IV sedative, hypnotic agent for use in the induction and maintenance of anesthesia or sedation. The warning on the Propofol labeling states that for general anesthesia or monitored anesthesia care, Propofol should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical diagnostic procedures. This is often what you’ll be told is the manufacturer’s labeling that prevents Propofol being used by a non-anesthetist.

However, max sedation is very different from moderate sedation since that type of sedation can require at any time that the health professional may have to deliver general anesthesia to the patient. The American Society of Anesthesiology clearly defines this differentiation in a paper called Distinguishing Monitored Anesthesia Care from Moderate Sedation Analgesia, and that was dated October 27, 2004.

Our point in bringing this to your attention is that the level of intended sedation, as you’ve heard this morning, is paramount. Any sedative or narcotic currently used in clinical practice can result in the over-sedation of a patient if the health care professional is not properly trained in the delivery of that particular drug for the purposes of sedation. When Propofol is given for minimal or moderate sedation, stopping the drug administration will result in the reversing of the effects of the drug due to its short half-life. Propofol is considered a self-reversing agent that is rapidly eliminated from the body when administered in an appropriate manner for minimal to moderate sedation.

Also, as you have heard from Dr. Stein and Chris Newland, the majority of colonoscopies commonly performed today are already done without an independent anesthesia provider. They are done with a physician-nurse care team performing the colonoscopy and providing the sedation ordered by the physician. The RN practices under the direct supervision of the physician when administering a monitoring sedation. We already know that there is a shortage of anesthesia providers in the state of Florida, so requiring an anesthesiologist or a CRNA to be present for moderate sedation with Propofol will impact the availability of colonoscopy procedures. When FDA approved, the SEDASYS System would allow an on-label administration of Propofol by a nurse under the supervision of the physician for minimal to moderate sedation.

On May 28, 2009, the FDA Review Panel recommended that the SEDASYS System be approved. For these reasons, we request that the proposed rule either be withdrawn in its entirety or amended to allow Propofol to be administered by physician-RN teams when used with FDA-approved technology. Thank you.

DR. COLIN: Thank you. Board members, do you have any questions, comments?

(No response.)

DR. COLIN: Thank you.

MS. GUSTAFSON: Next on the agenda is Shands Health Care. The letter is on page 32737, begins on that page. Is there anyone here from Shands, a representative of Shands?

(No response.)

MS. GUSTAFSON: All right. They’re apparently relying on their written submission.

Next is the Florida Osteopathic Medical Association.

MR. WINN: Good morning. My name is Jason Winn. I’m the general counsel for the Florida Osteopathic Medical Association. I appreciate the opportunity to appear before you this morning. I wanted to bring to the Board of Nursing’s attention that should the Board of Nursing promulgate this rule and pass this rule, the Florida Osteopathic Medical Association will file a rules challenge based upon our belief that it exceeds the scope of the Board of Nursing’s authority. Also, that there are current osteopathic rules for office-based surgery and rules for office-based surgery for medical doctors that already are in place that restrict or put into place protocols that allow for the doctors to supervise directly, and we believe that the promulgation by the Board of Nursing of this rule will be in direct conflict with the rule of the Board of Medicine and the Board of Osteopathic Medicine. Thank you.

DR. COLIN: Board members, do you have any questions?

(No response.)

MR. WINN: Thank you for the opportunity to address you.

DR. COLIN: I believe Dr. McDonough has a question.

MR. WINN: Yes?

DR. McDONOUGH: Counselor, once again I would proffer the question that I raised with the representatives of the Oral-Maxillofacial Surgery group, which is, is it your contention that the Florida Board of Osteopathic Medicine for whom I have great respect having been a faculty member at an osteopathic medical school for fifteen years – is it your contention that rules promulgated by the Board of Osteopathic Medicine in Florida are binding upon the practice of registered nurses in setting standards?

MR. WINN: I believe the Florida Legislature allowed for the Board of Osteopathic Medicine and the Board of Medicine to promulgate rules based upon office-based surgery. In those rules, the legislature allowed the Board of Medicine and the Board of Osteopathic Medicine to regulate how they interact with other personnel, including licensed practical nurses and registered nurses. So, yes.

DR. McDONOUGH: How they interact with nurses, not how nurses act or don’t act, but how they interact; is that correct?

MR. WINN: How they supervise and interact with those nurses, yes. The Florida Legislature allowed the individual boards to promulgate office-based surgery rules on that.

DR. COLIN: I’d like to call on Ms. Gustafson.

MS. GUSTAFSON: I’d like to point out to the Board that I was counsel to the Board of Medicine during the promulgation of the office surgery rules and the Legislature didn’t allow them to do anything. The Board of Medicine decided that it was necessary to promulgate office surgery rules because of the death rate resulting from office surgeries in Florida. The Legislature has chosen not to amend their statute to take away their authority to regulate that area, but the Legislature was not consulted and did not allow the Board to do anything.

DR. COLIN: Thank you. Any other questions? Dr. McDonough?

DR. McDONOUGH: Further for the record, we’ve been hearing people come forward and give testimony about registered nurses administering Propofol and other sedative drugs under the direct supervision of a provider authorized to administer those drugs, such as an oral maxillofacial surgeon or a physician. I would like to point out that this question was actually settled, I believe, in 2002 by a declaratory statement that was issued by this Board on the 20th of February when a position statement was requested by a practitioner who asked whether it was appropriate for a registered nurse to administer Propofol intravenously under the direct supervision of an anesthesiologist who remained physically present in the room the entire time or to monitor patients who had received Propofol given by an anesthesiologist or to give subsequent doses of Propofol after the initial dose had been given by an anesthesiologist, and I quote to you in part the result of that request.

It says, “Based upon the foregoing, the petition is answered in the following manner: It is not within the scope of practice of a registered nurse who is not a nurse anesthetist to administer Propofol pursuant to the verbal or written orders of an anesthesiologist who remains in the procedure room during the entire process. Further, it is not within the scope of practice of a registered nurse who is not a nurse anesthetist to inject an additional dose of Diprovan through an IV port after the anesthesiologist administered the original Diprovan dose. It is not within the scope of practice of a registered nurse who is not a nurse anesthetist to monitor a patient who has received Diprovan when an RN had administered the Diprovan pursuant to a verbal or written order given by an anesthesiologist who remains physically present in the room throughout the procedure. It is not the scope of practice of a registered nurse who is not a nurse anesthetist to monitor a patient who has received Diprovan, even if the anesthesiologist remains in the room physically present throughout the procedure. It is not within the scope of practice of a registered nurse who is not a nurse anesthetist to monitor a patient who has received Diprovan administered by an anesthesiologist who then performs a block, even if the anesthesiologist remains in the room the entire time. This order becomes effective upon filing with the clerk 20 February 2002.”

My point being the proposed rule regarding the administration of Diprovan does nothing but put into rule the declaratory ruling that has been in effect in this state as promulgated by this Board seven years ago. So if there are people who are doing as has been suggested by people who are providing testimony, the Board would clearly decide as they did previously that that is not within the lawful practice of nursing as defined by this Board. So I would contend that we are doing nothing but attempting to memorialize in rule what has already been stated in an individual case regarding a declaratory statement.

DR. COLIN: Thank you.

MS. GUSTAFSON: Next is the Florida Emergency Nurses Association. Is there anyone here from the Florida Emergency Nurses Association? All right. The Board will consider the written submission of that organization.

The Society of Plastic Surgeons. Is there someone here from the Society of Plastic Surgeons?

MR. NEWLAND: Chris Newland on behalf of the Florida Society of Plastic Surgeons. We’d like to rely upon the written record and support the testimony given by other medical groups.

DR. COLIN: Thank you.

MS. GUSTAFSON: Next on your disk is GI Physicians and Nurses. Is there a representative of that group? GI Physicians and Nurses?

(No response.)

MS. GUSTAFSON: All right. Those are the letters that have been received about this to make written comments.

Is there anyone else here who is attending to make comments regarding the rule?

Okay. Would you come and sit closer in the front rows there and then the Board will call on you to speak.

WHEREUPON,

ERNEST PAGE, M.D.,

a witness herein, after having been first duly sworn to tell the truth, was examined and testified as follows, to-wit:

DR. PAGE: Good morning to you all.

DR. COLIN: Good morning. My name is Dr. Ernest Page. I am here representing the Florida College of Emergency Physicians, and we did submit a letter and also a request for a public hearing, also. I am here representing the Florida College of Emergency Physicians. I am the immediate past president of the college by about six or seven weeks, and we are one of the largest chapters of the American College of Emergency Physicians having approximately 1,300 members and there are over seven million patients that visit the emergency departments in the state of Florida every year. We are here and we do have some concerns about the proposed rule that we are discussing today about conscious sedation.

In the emergency department, the emergency physicians and the nurses work closely together, and as some of you sometimes in very difficult and very hectic environments. We as emergency physicians have extensive training in moderate and in deep sedation through our training and many years of practice. We are well trained in advance airway management, intubation, and ventilatory support, and we have an excellent record in all of those. We have that excellent record not only because of our training but because of the excellent nurses that we work with on a daily basis, excellent well trained nurses, your colleagues, that we work with on a daily basis.

The American College of the Emergency Physicians and the Emergency Nurses Association developed a joint statement entitled, “The Delivery of Agents for Procedural Sedation and Analgesia by Emergency Nurses”, and this statement supports the delivery of medications used for procedural sedation and analgesia by credentials – which is important – excuse me, yes?

MS. GUSTAFSON: I don’t mean to interrupt you, Dr. Page, but did you send that with your letter, that statement?

DR. PAGE: We did. We sent our consensus statement and a statement, yes.

MS. GUSTAFSON: Okay. I thought you did send it, and if I didn’t find it on the disk, the Board will definitely be given that to consider in their decision making.

DR. PAGE: I appreciate that. This joint statement said that the emergency nurse should be able to give this medication, administer this medication, under the direct supervision of the emergency physician who is trained in moderate and deep sedation. These agents include but are not limited to Etomidate, Propofol, Ketamine, Fentanyl, and Medazolam.

There is a significant body of evidence that supports the safe and efficient delivery of these medications by registered nurses under the direct supervision of an emergency physician. The Joint Commission in Standards PC 12.20 and 13.20 also support nurses being able to administer these medications. And as I was preparing for this, I just came in from out of the country, so I did a little kind of perusing of the internet to see what other boards of nursing had done and obviously I could not go through all fifty states, but I found it interesting that several boards of nurses have found that this is within the scope of a registered nurse.

In 2005, the Minnesota board determined that it is within the scope of practice of RN’s to give medications classified as anesthetics for the purpose other than anesthesia. The board also stated that nursing practice includes both independent and delegated medical functions which may be performed in collaboration with other health team members.

South Dakota in 2004 restricted the use of Propofol and they reversed themselves one year later because they determined that it was safe, that particular medication.

In 2005, the North Dakota Board of Nursing determined that it was within the scope of the RN’s practice to administer these medications; and in 2008, the Wyoming Board of Nursing adopted the actual procedural sedation consensus statement which you all have in your packets, which was endorsed by the American College of Emergency Physicians, ENA, ANA, and others.

Patients come to the emergency department with multiple complaints. They expect safe and timely care when they present to the emergency department. These are our family members, our friends, and our neighbors.

The Florida College respectfully requests that the State Board of Nursing – the Florida State Board of Nursing make provisions in their regulations to allow nurses to administer sedation in the emergency department under the direct supervision of an emergency physician who is credentialed in conscious sedation. The focus should really be on the management of the patient after they receive these medications.

If I were a patient coming through the

emergency department, I would prefer that an RN that has been practicing for 20 years and administering medications to administer my medication, as opposed to the physician who does it on a very irregular basis. Many times it’s just not practical for the physician to administer this medication given the situation with an unstable, critical or even a trauma patient.

So I would argue to you that one size does not fit all, and you have to understand what the unintended consequences may be to patients that seek care, not only in the emergency department but outside of the emergency department, and I appreciate the doctor who has mentioned the declaratory statement in 2002. Just because that statement is in place does not mean that this Board cannot revisit that and see if that rule makes sense today. That was seven years ago. This is 2009, and as other boards have done, they have looked at this and have reversed themselves. We feel that it is safe for an RN who is properly trained, and I think that should be emphasized, properly trained and has done minimum training to administer this medication under the supervision of a physician that is trained in airway critical care management of pediatrics and adults. Thank you.

DR. COLIN: It’s great to hear your position about the role of nursing and the education of nursing and how you support what other states do. I would hope you would take that same position when it comes to advance practice nurses administering controlled drugs.

DR. DENKER: Dr. Colin?

DR. COLIN: Dr. Denker.

DR. DENKER: Along with Dr. Colin’s comment, I am pretty amazed here today that we talk about other states and Wyoming and all the rural states where there’s fewer physicians available to practice, and so they are more apt to promote the appropriate scope of practices for nurses, but following up on Dr. Colin’s statement, we come with the reverse argument when we have the – we come forward with advance practices and their right to prescribe controlled substances. I know that’s not the topic we’re discussing right now , but I think it’s very crucial for all of our physician colleagues in the audience in particular to hear that when it’s appropriate they’re opposed to that. You should know that there are only two states in the country that do not allow advance practice nurses to prescribe controlled substances and that’s Florida and Alabama. So I hope that you can take that lesson today. Thank you.

DR. COLIN: Any other comments from Board members? Dr. McDonough.

DR. McDONOUGH: Doctor, with the exception of the administration of anesthetic drugs to facilitate the emergency intubation or rapid sequence induction process in a patient being resuscitated or who is in extremis in the ER, and I would certainly personally support a clear statement in the rule that that type of procedure should be exempt.

What other types of procedural sedation do you see as being required in the emergency room that would not permit securing an anesthesia provider to administer the sedation.

DR. PAGE: We do a lot of procedural sedation, fracture reductions, shoulder reductions, knee/hip reductions, and as I mentioned there are over seven million people that seek emergency care every year. One of the things, I actually work in the Florida Hospital System here locally and one of the problems that our hospital has is that they came to us as the emergency group of 100 physicians and asked us if we would be in charge of procedural sedation on patients that were transferred in from outlying campuses. We had fractures that needed to be reduced and the reason being is that the anesthesiologist and the CRNAs were not interested in it and they didn’t have the manpower to do it. So the hospital came to us and asked us if we would be willing to do it. I think that if you don’t think we have a manpower issue as far as this goes, we really do.

We have rural emergency departments here in Florida who absolutely would not be able to get an anesthesia provider to come in for any type of procedural sedation and any type of reduction. As you know, this is a time-sensitive – these are time-sensitive injuries. When you have your shoulder that’s dislocated and you don’t have time to wait for the anesthesiologist to make it there in 60 minutes or an hour-and-a-half. So when I made my statement about the one size fits all –

DR. McDONOUGH: Counselor – excuse me - Doctor, we’re not accustomed to taking an hour-and-a-half to get to the hospital. People need Caesarian sections in moments, so my point is if you’re in a hospital that does operative deliveries, I could promise you that you’ve got an anesthesia provider a whole lot more available than an hour away, surely you’ll admit.

DR. PAGE: I work in a hospital that has 2,100 beds and our anesthesiology providers do not have any interest in coming to the emergency department to help out with any type of procedural sedation or any type of airway management. As a matter of fact, one of our hospitals which is a rural hospital, does not do surgery, does not have labor and delivery, and I can guarantee you that no anesthesiologist in Orlando even knows the address of where that hospital is. That particular hospital would probably not be able to get an anesthesiologist or a CRNA in in time to do a procedural sedation.

As you know, there are vascular concerns if somebody has a dislocation and there’s a vascular compromise and things of that nature, so one size does not fit all. There are hospitals out there that do not surgery, who do not have labor and delivery, and one of those hospitals we staff as a group, and our emergency physicians have to do all of those procedures and have to do the sedation, and that is just the realities that we do not have enough CRNA anesthesiologists that will do these procedures and are willing to come to the emergency department, and God forbid the patient not be insured, you know.

DR. McDONOUGH: Oh, my. I don’t believe anybody is suggesting that the ER physicians in your rural hospitals are not permitted to give these medicines or do these procedures.

DR. PAGE: Right.

DR. McDONOUGH: You guys can give whatever you want.

DR. COLIN: Let me just say we only have 15 minutes. There are a few more people who want to talk.

DR. PAGE: Okay.

DR. McDONOUGH: I’m through. Thank you.

DR. COLIN: Dr. Seabrook?

DR. SEABROOK: Thank you. For the physician who’s there and the others who have come, I’m curious. Did you bring the nurses with you who would like to do these procedures when you train them? Are they available to give some testimony as to how important it is for them to assume the additional risk and responsibility for this procedure?

DR. PAGE: Our Florida Emergency Nurses Association were really the ones that brought this issue to us and asked us to get involved, and they were supposed to have someone here today but there was a conference they were having of some nature, but they were the ones that really brought the issue to us and asked us if we would help them out on this particular issue.

DR. COLIN: We do have a letter from the Florida Emergency Nurses Association. But as I said before, I hope that you will use the same passion that you have about this issue to support nursing in controlled substances, advance practice nurses. Thank you.

MR. GARCIA: If I may, Dr. Page, you referenced in the letter that was sent to the Board office an addendum. That addendum did not make it into the envelope that was submitted, so the content was only the letter.

DR. PAGE: Okay. Well, we can certainly get you that information.

MR. GARCIA: Thank you.

DR. COLIN: Do you have it with you?

DR. PAGE: I do have some copies of it with me.

MS. GUSTAFSON: I think I have that and I’ll get it to you, and if not, I’ll contact Dr. Page.

DR. COLIN: Thank you. Dr. Denker?

DR. DENKER: I would like to comment on the purpose of the Board of Nursing’s deliberations on this issue. I believe I can speak for the Board in saying that our interest is in the safety of the patients. Much of this discussion tends to revolve sometimes around the convenience of other providers and physicians, according to the schedule. I have experienced issues in my facility and clinical practice where often times the request for nurses to administer this drug are based on the need to have somebody there when the physician either is not convenient for them to be there. I think that our rule making should be based on exactly the needs of the patient.

Partly what you’re saying is perhaps an emergency situation or whatever, but it seems that often nurses are prohibited from doing certain things when physicians see them as turf issues however they’re asked to do them when they provide convenience, and I hope that we really can take that into consideration in making these decisions.

DR. COLIN: Thank you.

DR. PAGE: Could I make one more comment to that? As I mentioned in my statement about the one size does not fit all in the emergency department, the emergency department is one of the few places where you do have a physician 24 hours a day seven days a week, and so it is a safe environment.

DR. COLIN: Thank you. You guys want to shoot for it?

MS. GUSTAFSON: Why don’t you all come and sit down?

Good morning and welcome. Yes?

MS. HANSEN: Good morning. I’m Jennifer Hansen. I’m regulatory affairs counsel with the Florida Medical Association.

MS. GUSTAFSON: You need to bring the microphone closer to you and speak directly into it. I don’t know why the population of Florida doesn’t like to talk into microphones, but the Board cannot understand you if you’re not talking directly into the microphone.

MR. GARCIA: And if you could all turn and face the court reporter so she can swear you in for the testimony. Thank you.

(Whereupon, the remaining speakers were sworn in by the court reporter.)

DR. COLIN: Thank you.

MS. HANSEN: Jennifer Hansen with the FMA. I would like to echo all the concerns that have been raised by the interested parties so far this morning. We don’t feel that this regulation is necessary. Nurses and physicians have been doing this for years.

DR. COLIN: Can you give us your name, please?

MS. HANSEN: Sure. Jennifer Hansen. Physicians and nurses have been doing this for years without incident –

DR. COLIN: Jennifer, I’m sorry; I don’t think the rest of the Board knew what group you are with. I believe you said the Florida Medical Association.

MS. HANSEN: The Florida Medical Association. DR. COLIN: Okay. Thank you.

MS. HANSEN: There are not any patient safety issues that have arisen. I think current law both the allopathic, the osteopathic, the Dental Practice Act, and the Nursing Practice Act adequately provide protections for safety. I think this regulation interferes with the physician’s relationship with his nursing team. I think everybody in this room agrees that that’s a very vital relationship in the practice of medicine.

And from a legal perspective, the effect of this proposed rule will be to regulate the practice of medicine and as such if this rule is adopted the Florida Medical Association will have no choice but to file a rule challenge.

DR. COLIN: Thank you. Is there anyone else?

Is there anyone else with you who is going to – yes.

A VOICE: I have some comments, but I heard you folks say – (inaudible, off microphone).

MS. GUSTAFSON: Are you all with Ms. Hansen? Okay.

MR. NEWELL: Good morning. Can you hear me?

DR. COLIN: Yes.

MR. NEWELL: Good. Madam Chair and members of the Board, good morning. I’m Robert Newell; I’m an attorney. My office is in Tallahassee, Newell, Terry & Douglas. I represent three not-for-profit full service community hospices in the state of Florida. I would pause at this moment to ask whether or not you have received, and Mr. Garcia stepped away, a letter from the Florida Hospice and Palliative Care Association with attachments that was dispatched on October 2nd. You have that in your possession. Is it in your agenda book today?

DR. COLIN: Yes.

MR. NEWELL: Thank you for that confirmation. My remarks are corollary to that. I invite your attention to the Florida Hospice and Palliative Care Association’s work product. It represented an effort of a number of hospices to confirm for you that palliative sedation, a form of conscious sedation, when delivered in a hospice program to imminently dying patients is a form of sedation that should not be prohibited by your rule either because it is neglected to be mentioned expressly and appropriately in the rule or because by implication it could be inferred from the rule you eventually put together. The current reference to hospice in the rule, the proposed rule, appears to suggest that it is up in subsection one, which appears to really talk more about procedural sedations and sedations in other venues besides hospice.

Hospice, as you know, is an end of life program; it is largely nurse led. There are medical directors assigned to each interdisciplinary team, but it is a very nurse driven program and has been since its inception. It was started many years ago by the Visiting Nurses Associations who got together and saw a need for unique and different end of life care built around palliation rather than curative effort. It is in that context that palliative sedation is infrequently but nonetheless occasionally used. It’s an important tool in the tool chest of helping patients who are entering the essentially active dying process to have comfort and to treat refractory symptoms, symptoms that can’t be addressed any other way.

The Florida Hospice and Palliative Care Association has an effort to be – we leave to others and to this Board to determine the necessity of this rule. That’s what you advertised in your notice this workshop to be about in the procedural context and in a surgical context, so on and so forth. That’s your business.

To the extent you are going to promulgate a rule, though, we would ask that you expressly consider defining palliative sedation as a type of sedation, and we included a proposed definition in that regard for you and that you define refractory symptoms, and that you provide a permissive provision. We thought that more appropriate than trying to carve out some exception. We thought a permissive provision would be more consistent with the work product that you already have worked on and that the clarifying permissive provision would say a registered nurse or licensed practical nurse may pursuant to physician order administer or monitor the administration of medications for palliative sedation in a hospice program. So we respectfully suggest an effort has been made to narrow it down and keep it tight and keep it focused to the palliative venue. So I commend that work product to your attention on behalf of my specific clients who need that tool in this special setting, whereby definition death is a very time-sensitive situation to achieve patient comfort.

Accompanying me today is Mary McElroy. She’s the chief nursing office. She is not here at the table, but she is in the audience. She is available to answer any specific questions you have about how protocols for palliative sedation might differ from procedural sedation in an acute care venue. She is the chief nursing officer for Community Hospice of Northeast Florida.

I think that concludes my comments. I’d be happy to answer questions for you.

DR. COLIN: Board members, do you have any questions?

DR. McDONOUGH: I would just like to state that I think your argument is extremely well stated. It makes perfect sense and I can only speak for myself as one Board member, but we would certainly support the role that you would like us to take in terms of writing permissive language for palliative sedation. That’s absolutely totally appropriate.

DR. COLIN: Thank you. Next?

MR. NEWELL: Thank you for your courtesy and attention.

DR. COLIN: Thank you.

MS. SALIMONE: Good morning, Madam Chair. I am Shannon Hartsfield Salimone. I am an attorney for Holland & Knight. We are general counsel to the Florida Society of Anesthesiologists and we thank you for the work that the Board has done over the past six years to try to get a rule passed to address the role of registered nurses in conscious sedation. We fully support the Board of Nursing’s commitment to patient safety and also would support the Board in dealing with the issues raised by the Joint Administrative Procedures Committee. We believe that this rule does conform to past concerns raised by JAPC. JAPC has stated that the Board of Nursing has the authority under statute to define unprofessional conduct and that is what this rule attempts to do.

I believe that the testimony given today illustrates very clearly the need for this rule. There was mention in the testimony of the fact that there haven’t been any gastro-procedure related deaths in the past seven years. I don’t think it’s any coincidence that the Board of Nursing passed a declaratory statement regarding the role of registered nurses in administering Propofol seven years ago. That declaratory statement promoted patient safety, and we think the time has come for a rule to do the same thing. If I may, I’d like to introduce Dr. Hector Vila who is representing the Florida Society of Anesthesiologists. He is on their Board of Directors and he would like to speak briefly if he may.

DR. COLIN: Thank you.

WHEREUPON,

HECTOR VILA, M.D.,

a witness herein, after having been first duly sworn to tell the truth, was examined and testified as follows, to-wit:

DR. VILA: Madam Chair and members of the Board, I’m Hector Vila. I’m an anesthesiologist. I think you probably know me. We’ve been through this journey for some time together and I know the time is constrained here, so I’ll be brief in my comments.

Just observations about the testimony thus far this morning. What’s striking to me is how similar this is to what the Board of Medicine went through in the late ‘90s and early 2000, and I was at many of those meetings and the testimony was very similar. The testimony from individuals who were economically affected and the lack of testimony from, for instance, patients who may be – their health may be affected. So there’s testimony here about folks that are economically affected. There has been a striking lack of specific testimony about what words it is they don’t like, if you notice. So I think your rule is pretty close and you’ve worked on it for six years.

But let me tell you, the journey through the Board of Medicine was exactly similar. There was this testimony by streams of folks who didn’t like it and then there was a stream, a following stream of some of the legal challenges, and that rule survived. It’s fortunate that that rule survived because now patients have survived, and if you look back at the statistics, and I have with me the meeting materials from the Surgical Quality Assurance Committee of the Board of Medicine, which met October 1, 2009, and there’s tables in here and data. You can see that the numbers of deaths have steadily declined in Florida offices. They’ve steadily declined.

Now the reason that Florida office surgery rules are important is because this is the area where there were no rules before. Remember, hospitals and surgery centers have existing rules that oversee what nurses can do or what physicians can do, but in the office there were no rules. So this is where your rule is going to be important is in the physician office where there are no rules.

In the offices there were a lot of deaths until the Board of Medicine enacted their rules. The rules will survive. You have done the right thing. You’ve done your job. You’ve set the clinical target. That’s our job as clinicians is to set the clinical target. Let the legal folks hash out exactly how it sees its way through, but the clinical targets are important, and so I encourage you to be strong. I encourage you to persist. I think the lack of testimony today about the specifics of the language they’d like to be changed indicate you’re probably pretty close on the language. I’m okay with the ER physicians because those patients are going to be intubated. So in rapid sequence induction I’m okay; the intent there is to intubate the patient.

For the procedural sedation, that’s not the intent. So I’m okay with that. Okay with the hospice language. In fact, I think the hospice language is in your rule already. If they want to add more to it, that’s fine.

The issue today before us is whether or not the rule is necessary. It’s my understanding you received a letter from a parent of a patient that died in an office surgery death. I hope that you’ll consider that, and there have been deaths, and if you look again at the Board of Medicine documents – in fact, if you look at just the first page of deaths that occurred in Florida, there’s a number of these deaths that involved RN’s administering the sedation. Just on this first page there’s five deaths in which an RN is listed as the anesthesia provider, so the rule is necessary. You have the reason to do it. The data is here.

I’m not coming before you and saying in my opinion, I’m coming before you and unfortunately I’m citing actual deaths that have occurred.

Secondly with regard to Propofol, there’s been some specific testimony this morning about Propofol, and again I want to provide data for you. The most recent data that’s come before anesthesiologists is the article, a current opinion in Anesthesiology, 2009, volume 22, page 502, “Risk Analysis of Anesthesia at Remote Locations from our Closed Claims”.

This is where anesthesiologists’ closed claims or lawsuits are evaluated. The findings here are striking. There has been an increasing proportion of deaths occurring in sedation anesthesia, not in general anesthesia but in sedation anesthesia. This is administered by anesthesiologists and the deaths involve older and sicker patients. The proportion of these deaths as I said is increasing. They’re mostly involved with respiratory events, and Propofol was the drug administered in 78 percent of these deaths. So as a result, the Board of – the American Society of Anesthesiologists will consider next week at its annual meeting actual increase in the standards for which Propofol is administered, not decreased, but increasing the standards.

So at a time when even the anesthesiologists are looking to make it more strict in the way that patients are monitored that are receiving Propofol, I encourage you please don’t weaken the standards. I mean, Propofol already has specific language in the prescribing information as testified by Ethicon that it should only be administered by individuals trained in general anesthesia. Now they’re sort of splitting hairs here saying well, we’re going to administer it in moderate sedation doses. I’ve got to tell you, that device is fraught with issues. It hasn’t passed the FDA. It’s tied up in a committee. The device administers 200 micrograms per kilogram per minute of Propofol, which the prescribing information for Propofol lists as a general anesthetic dose. So there’s a million problems with that device. Please don’t alter your course on a device that’s not even approved.

So Propofol is an issue, there are deaths out there, you’re doing the right thing, be strong.

DR. COLIN: Thank you. Board members, do you have any questions or comments?

Thank you.

Is there anyone else in the audience?

WHEREUPON,

JIM LYNN, Esquire,

a witness herein, after having been first duly sworn to tell the truth, was examined and testified as follows, to-wit:

MR. LYNN: Good morning. My name is Jim Lynn. I’m the attorney for the Florida Association of Nurse Anesthetists, and sitting with me is John McFadden, the past president of the Association. I’m not going to spend a whole lot of time, but I just did want to comment that it is not often that the Florida Association of Nurse Anesthetists and the Florida Society of Anesthesiologists come together on an issue, but this is one of those occasions. We certainly support the efforts of this Board in putting together a rule on what is becoming a very critical issue of concern. As has been pointed out several times, your role in this is protecting the public, protecting the patients. Those are the folks that you haven’t heard from today, but I know that this Board takes that role very seriously. So without saying any more, I’d like Dr. McFadden to provide his comments.

DR. COLIN: Thank you.

DR. McFADDEN: Good morning. I am Dr. McFadden. I am Associate Dean of the College of Health Sciences at Barry University. I am a certified registered nurse anesthetist, past president of the Florida Association of Nurse Anesthetists, a former hospital nurse administrator. My master’s degree and doctoral degrees are in nursing; and most importantly I am a 25 year veteran registered nurse licensed in the state of Florida who has provided procedural sedation in the critical care units, in the emergency room, and also has provided sedation for endoscopy in an outpatient surgery center in Florida since 1999.

I will not speak as eloquently as some of the attorneys who have commented on nursing practice; however, I do believe I am well qualified based on my education and experience to comment on what is professional versus unprofessional clinical nursing practice.

Like the profession of nursing, this Board has a long standing history of supporting rules and policies that foremost serve to protect our patients, the public. This proposed rule is consistent with that goal and all the structure provided by multiple groups to guide safe nursing practice. It is consistent with your previous declaratory statement. It is consistent with the FDA and DEA approved manufacturer’s label for the administration of many drugs, which for Propofol – a drug whose name has become a household word earlier this summer – states and I quote, “...should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical or diagnostic procedure.”

Propofol because it has been mentioned many times this morning is a unique drug with properties that create an anesthetized state in a manner in which we’re not quite clear how that works, but we also know it results in numerous physiological, cardiovascular, and respiratory changes. Again, I defer to the Michael Jackson case to make my point.

It is also consistent with the prevailing standard of practice in the state of Florida. I do not believe this rule conflicts with previous rules. It certainly is necessary as we’re hearing this morning. It is clear to me that this rule provides a mechanism for Florida RN’s like me to administer these drugs in a fashion consistent with this structure. I agree that RN’s should be able to perform acts and administer medications in a manner consistent with their level of education and experience. This Board of Nursing provides for that. It recognizes that RN’s trained in emergency and critical care and hospice nursing may administer these drugs in certain situations.

It also recognizes that appropriately trained and experienced RN’s, that is, those prepared as certified registered nurse anesthetists may administer these drugs in certain situations. That is to create sedation, which we all know is a dynamic state and can lead to a dangerous outcome.

CRNA’s are the Florida RN’s with the level of education and experience necessary to safely administer these drugs for their intended purpose. It is for that reason that I speak in support of this proposed rule. Thank you.

DR. COLIN: Thank you. Board members, any questions or comments? Thank you.

I believe we have reached our time. I’m just going to ask, is there anyone else in the audience who wished to speak on that issue?

(No response.)

DR. COLIN: Great. Seeing none, thank you for your comments and we appreciate the opportunity to interact with the public and we will be continuing with our efforts to make sure that we continue to protect the patients, the public in the state of Florida.

* * * * *

(Whereupon, this concludes the excerpted portion of the record.)

C E R T I F I C A T E

THE STATE OF FLORIDA, )

COUNTY OF WAKULLA, )

I, Suzette A. Bragg, Court Reporter and Notary Public, State of Florida at Large,

DO HEREBY CERTIFY that the above-entitled and numbered cause was heard as herein above set out; that I was authorized to and did transcribe the proceedings of said matter, and that the foregoing and annexed pages, numbered 1 through 61, inclusive, comprise a true and correct transcription of the proceedings in said cause.

I FURTHER CERTIFY that I am not related to or employed by any of the parties or their counsel, nor have I any financial interest in the outcome of this action.

IN WITNESS WHEREOF, I have hereunto subscribed my name and affixed my seal, this 20TH day of October, 2009.

________________________________

SUZETTE A. BRAGG, Notary Public

State of Florida at Large

My Commission Expires: 2/21/2013

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