STATE OF FLORIDA
DIVISION OF ADMINISTRATIVE HEARINGS
FLORIDA MEDICAL ASSOCIATION, INC.; FLORIDA OSTEOPATHIC MEDICAL ASSOCIATION; AND FLORIDA PODIATRIC MEDICAL ASSOCIATION,
Petitioners,
vs.
DEPARTMENT OF HEALTH, BOARD OF NURSING,
Respondent,
and
FLORIDA ASSOCIATION OF NURSE ANESTHETISTS; AND FLORIDA NURSES ASSOCIATION,
Intervenors.
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SUMMARY FINAL ORDER
This cause is before Administrative Law Judge Lisa Shearer Nelson on Petitioners' Motion for Official Recognition and for Summary Final Order, and Intervenor Florida Association of Nurse Anesthetists' ("FANA") Motion to Dismiss and for Summary Final Order, with which Respondent, the Florida Board of Nursing ("the Board") and Intervenor, Florida Nurses Association ("FNA") have joined. After review of the arguments and documents presented in support of those arguments, no dispute of material fact
remains, and this case is appropriate for disposition by summary
final order.
APPEARANCES
For Petitioner Florida Medical Association:
Jeffery M. Scott, Esquire Holly R. Miller, Esquire
113 East College Avenue Tallahassee, Florida 32301
For Petitioner Florida Osteopathic Medical Association:
Jason Winn, Esquire
119 East Park Avenue Tallahassee, Florida 32301
For Petitioner Florida Podiatric Medical Association:
Wendy Smith Hansen, Esquire 9670 Deer Lake Drive Tallahassee, Florida 32312
For Respondent: Lee Ann Gustafson, Esquire
Office of the Attorney General The Capitol, Plaza One Tallahassee, Florida 32399-1050
For Intervenor Florida Nurses Association:
Cynthia A. Mikos, Esquire Anna G. Small, Esquire
202 South Rome Avenue, Suite 100 Tampa, Florida 33606-1854
For Intervenor Florida Association of Nurse Anesthetists: James W. Linn, Esquire
Glenn E. Thomas, Esquire
Paul H. Amundsen, Esquire Lewis Longman & Walker, P.A.
315 South Calhoun Street, Suite 830 Tallahassee, Florida 32301
STATEMENT OF THE ISSUE
The issue to be determined is whether proposed amendments to Florida Administrative Code Rule 64B9-8.005 (rule 64B9-8.005 or "the proposed rule") constitute an invalid exercise of legislatively delegated authority? Specifically, the Second Amended Petition raises the following issues with respect to the proposed rule: a) whether the Board exceeded its rulemaking authority, citation to which is required by section 120.54(3)(a)1., Florida Statutes; b) whether the proposed rule enlarges, modifies, or contravenes the specific provisions of law implemented, citation to which is required by section 120.54(3)(a)1.; c) whether the proposed rule is vague;
whether the Board has complied with the essential requirements of rulemaking provided in sections 120.54 and 120.541; and e) whether the proposed rule amendments are supported by the necessary facts.
PRELIMINARY STATEMENT
On April 25, 2012, Petitioners, Florida Medical Association ("FMA"), Florida Osteopathic Medical Association ("FOMA"), and Florida Podiatric Medical Association ("FPMA")(collectively, "Petitioners"), filed a Petition for Administrative Determination of Invalidity of Proposed Rule, challenging a proposed amendment to the Board's "Unprofessional Conduct" rule identified as Florida Administrative Code Rule 64B9-8.005.
An Amended Petition was filed the next day. The case was noticed for hearing to commence May 29, 2012.
On May 8, 2012, Petitioners filed an unopposed motion for continuance, due to an upcoming public hearing to be held on the proposed rule, and the case was rescheduled for June 26, 2012.
On May 30 and June 5, 2012, the FANA and the FNA (collectively, "Intervenors"), respectively, filed Petitions to Intervene and by Orders dated June 4, 2012, and June 8, 2012, FANA and FNA were granted intervenor status. On June 13, 2012, Petitioners filed a second Motion for Continuance, citing the need for additional time to complete discovery and for additional time to complete the hearing. Respondent and FANA also indicated that additional hearing time would be necessary. Accordingly, the case was rescheduled for August 28-30, 2012.
Discovery and motion practice has been extensive and is reflected in the docket at the Division of Administrative Hearings. At the final motion hearing held August 24, 2012, the forecasted track of Hurricane Isaac predicted that the storm would make landfall in the Big Bend area during the time scheduled for hearing. Based upon the uncertainty created by this forecast, the hearing was rescheduled for September 10-11, 2012, and on August 27, 2012, an Order Re-scheduling Hearing was issued to that effect. However, after review of FANA's Motion to Dismiss and for Summary Final Order, and Petitioners' Motion
for Official Recognition and for Summary Final Order, it became apparent that no real dispute of material fact exists, and the case could be decided based upon the pleadings, affidavits, depositions and responses to discovery on file. An Order Canceling Hearing was issued September 6, 2012.
The Board submitted a Request to Take Official Notice of 27 Declaratory Statements issued by the Board, as well as a ruling by the Department of Health and Human Services, Food and Drug Administration, Docket No. FDA-2005-059: Response to Petition by the American College of Gastroenterology, August 11, 2010 ("FDA Ruling"). FANA also requested official recognition of the FDA Ruling. No party objected, and official recognition is taken of the FDA Ruling and the Declaratory Statements. The undersigned notes that a copy of the FDA Ruling is also attached to documents provided to the Joint Administrative Procedures Committee ("JAPC"), whose rulemaking file as provided by Petitioners is also officially recognized.1/
All references to the Florida Statutes are to the 2012 codification, unless otherwise indicated.
FINDINGS OF FACT
Based upon the pleadings, depositions, answers to interrogatories, and admissions on file, together with affidavits filed pursuant to section 120.57(1)(h), Florida Statutes, the following facts are found:2/
The Players
Petitioner, FMA, is a professional association of doctors of allopathic and osteopathic medicine in Florida, located in Tallahassee. The FMA is organized and maintained for the benefit of approximately 20,000 licensed Florida physicians, with a primary purpose of acting on behalf of its members by presenting their common interests before various governmental entities of the State of Florida, including the Department of Health ("the Department" or "DOH") and the professional licensing boards under the Department's regulatory umbrella.
Petitioner, FOMA, is the state association for osteopathic physicians in Florida. FOMA also maintains its headquarters in Tallahassee, Florida, and seeks to represent its members' common interests before various governmental entities in the State of Florida, including the Department and the professional licensing boards.
Petitioner, FPMA, is the statewide professional organization for podiatric physicians, and is also located in Tallahassee. A primary purpose of FPMA is to represent the common interests of podiatric physicians before the Florida Legislature and state agencies and boards, including the Department and its regulatory boards, whose rules and enforcement proceedings impact the practice of podiatric medicine and the delivery of podiatric medical care to patients.
Respondent, the Board, is the regulatory body charged with the licensing and regulation of nurses pursuant to section
20.43 and chapters 456 and 464, Florida Statutes.
Intervenor, FANA, comprises approximately 3,500 certified registered nurse anesthetists ("CRNAs") and student nurse anesthetists currently licensed in Florida. A primary purpose of FANA is to represent its members' common interests before government agencies, including the Board.
Intervenor, FNA, is a professional association of registered nurses licensed in the State of Florida, with a primary purpose of serving and supporting all registered nurses through professional development and advocacy. The Association has approximately 5,000 members, and advocates for its members before the Legislature and state agencies, including the boards within the Department.
The History of the Proposed Rule
Proposed Rules 64B9-17.001-.003
At issue in this proceeding is the proposed rule as reflected in the Notice of Change published in the Florida Administrative Weekly ("FAW") on April 6, 2012. In order to place the arguments and responses of the parties and intervenors in context, however, it is necessary to provide the history of the Board's efforts to adopt a rule dealing with the standards for use of conscious sedation.3/
On September 26, 2003, at Volume 29, Number 39, page 3797 of the FAW, Respondent published a Notice of Rule Development for proposed rules 64B9-17.001-.003, entitled "Statement of Intent and Purpose," "Definitions," and "Competency and Knowledge Requirements," respectively. The notice stated that the "Purpose and Effect" of the proposed rules was "to determine the permissible scope of practice of the registered nurse in the administration of new and advanced treatments and medications for conscious sedation." The identified subject area to be addressed specified that the new proposed rules "set forth the definitions of conscious sedation and the competency and knowledge requirements of registered nurses."
The September 26, 2003, Notice listed the specific authority for the rules as section 464.003(3)(a)(which defines the practice of professional nursing) and section 464.006 (the Board's general rulemaking authority). As laws implemented, the Notice listed section 464.003(3)(a); section 464.012(3) (providing that advanced registered nurse practitioners shall perform listed functions within the framework of an established protocol); and section 464.015(1) and (5)(restricting the use of the titles RN and ARNP). Drafts of the proposed rules were published with the notice.
On November 24, 2004, in Volume 30, Number 48, page 4962 of the FAW, the Board published a Notice of Proposed Rulemaking for proposed rules 64B9-17.001-003. The Purpose and Effect for the proposed rules was "[t]o set forth professional and educational standards and requirements for nurses who administer conscious sedation to patients, and to define which types of sedation are within the scope of registered nurses licensed under Chapter 464, F.A.C. [sic]." The specific authority and laws implemented were the same as those identified in the September 26, 2003, Notice of Rule Development.
On March 4, 2005, in Volume 31, Number 9, page 875 of the FAW, the Board published its withdrawal of proposed rules 64B9-17.001-.003.
On March 18, 2005, in Volume 31, Number 11, page 1074 of the FAW, the Board again noticed proposed rules 64B9-17.001-
.003. The Purpose and Effect and Summary were identical to that in the November 24, 2004, Notice, with the exception that the reference to the Florida Administrative Code was corrected to reference Florida Statutes. While the referenced specific authority remained the same, section 464.019(1)(j) and (n) was added to the law implemented. Section 464.019, Florida Statutes (2004)(the version in effect at the time) provided the procedure for the approval of nursing programs; however, there were no subsections (1)(j) and (1)(n).
On November 4, 2005, in Volume 31, Number 44, page 4025 of the FAW, the Board published a Notice of Change with respect to the proposed rules. The Notice of Change stated that the proposed rules were being changed in accordance with section 120.54(3)(d)1. Although not noted as a change, the law implemented listed for the first time section 464.018(1)(h), which makes it a disciplinary violation to commit unprofessional conduct, as defined by Board rule.
On February 9, 2006, Suzanne G. Printy, Chief Attorney for the JAPC, wrote to counsel for the Board, to provide JAPC's review of the rule.4/
On April 14, 2006, in Volume 32, Number 15, page 257843 of the FAW, the Board published a Second Notice of Change related to proposed rules 64B9-17.001-.003. The Notice indicated that "several additional amendments to the proposed rule were made to address concerns expressed by the Joint Administrative Procedures Committee and by parties affected by the proposed rules."
On June 22, 2006, Board counsel provided to JAPC a detailed response to JAPC's comments regarding the proposed rules. The letter stated that a Notice of Change "will be published shortly or has already been published."
On July 11, 2006, Ms. Printy again wrote to Board counsel, expressing continued concerns with the proposed rules. Included in the concerns listed by Ms Printy were the following:
[Re: 64B9-17.001(2)]: This rule states that "the act of administering medications for conscious sedation by a registered nurse without the education and verification of competency outlined in this rule would constitute unprofessional conduct . . ." Subparagraph
464.003(3)(a)2., F.S., defines the practice of nursing as including, "The administration of medications and treatments as prescribed or authorized by a duly licensed practitioner authorized by the laws of this state to prescribe such medications and treatments." No additional training or education is required by that statute cited as law implemented.
Paragraphs 464.018(1)(h) and (n), F.S. do allow the board to define "unprofessional conduct" and to require licensees to engage solely in acts for which the licensee is qualified by training or experience.
Nonetheless, neither of these statutes authorizes the board to establish separate and specific education and training requirements in order to practice professional nursing, i.e., to administer "medications and treatments as prescribed or authorized by a duly licensed practitioner . . . ." Licensees can be trained or educated in the area of anesthesia beyond the level of the basic nursing education programs specified in the rules of the Board of Nursing. If such licensees are then qualified by training or experience to administer such anesthesia, the practice of such licensees would neither constitute unprofessional conduct nor the failure to meet minimal standards of acceptable and prevailing nursing practice. Requiring all nurses to meet the education and verification requirements of
the proposed rules in order to administer anesthesia appears to create an unauthorized level of licensure, thereby enlarging upon the requirements of ss.
464.003, .012 and .018, cited as law implemented.
This rule also prohibits all registered nurses from administering medications for the purpose of any general anesthesia.
Sections 464.003(3)(a)2. and .018(1)(n), F.S., authorize licensees to administer medications and treatments as prescribed or authorized by a duly licensed practitioner authorized by the laws of this state to prescribe such medications and treatments and to engage in acts for which the licensee is qualified by training or experience. If a licensee is both authorized by a practitioner to administer anesthesia, and is trained or educated in that practice, please provide and explain the specific statute authorizing the board to prohibit that licensee from administering general anesthesia without any opportunity to demonstrate competency in that area. This rule appears to contravene the laws being implemented.
On August 25, 2006, counsel for the Board responded to JAPC's concerns. Ms. Printy wrote to Board counsel again on September 21, 2006, reiterating some of her ongoing concerns with the proposed rules. A discussion between Ms. Printy, Board counsel and the Executive Director of the Board apparently occurred, which is confirmed by letter dated November 2, 2006.
In that letter, Ms. Printy outlines several changes to the proposed rules that were discussed.
On December 11, 2006, a proposed change to the proposed rules was faxed to JAPC. A Notice of Change was published in Volume 32, Number 51, page 3309172 of the FAW, on December 22, 2006.
On January 2, 2007, Ms. Printy wrote to Board counsel, again expressing concerns about the proposed rules as reflected in the most recent Notice of Change. Her concerns stated in part:
These rules continue to require professional nurses to meet the specific training and education requirements of Rule 64B9-17.003, in order to induce conscious sedation. Please explain how these rules reflect the statutory authorization of s.
464.018(1)(n), F.S., that a nurse may be qualified by "training or experience" to meet the standards of acceptable and prevailing nursing practice to induce conscious sedation.
In addition, Ch. 464, F.S., neither imposes nor authorizes training requirements to administer medications or treatments as prescribed or authorized by a licensed practitioner authorized to prescribe such medications and treatments. These rules, therefore, appear to enlarge upon the law implemented. See, Ortiz v. Department of Health, Board of Medicine, 882 So. 2d 402 (Fla. 4th DCA 2004) and Florida Department of Health & Rehabilitative Services v.
McTigue, 387 So. 2d 454 (Fla. 1st DCA 1980).
On January 10, 2007, the Florida Society of Anesthesiologists and the FMA filed a challenge to the proposed
rules. Florida Soc'ty of Anesthesiologists v. Dep't of Health,
Bd. of Nursing, Case No. 07-0122RP.
On January 30, 2007, Board counsel again wrote to JAPC staff regarding the proposed rules. Among the statements in her letter, counsel cited to section 464.019, Florida Statutes, as giving the Board the authority to establish the minimal education requirements for licensure. She states:
Your analysis confuses two issues:
the minimal education or training required for licensure and (2) the scope of licensure, which is set forth in statutes, including disciplinary provisions. Competency for licensure and competency for disciplinary purposes are not identical. Not every registered nurse who has completed a minimal education may be qualified to administer conscious sedation-
-applicants can achieve license [sic] as a registered nurse after completion of a two year program, or after completion of a four year "BSN" program. The "scope of practice" isn't different for the achievers of the Associate Degree program or the Bachelors Degree program; however, their training programs may prepare the BSN graduate to perform procedures/ treatments/skills at a more advanced level than an AS graduate is qualified to perform. The conscious sedation rules advise licensees that a registered (professional) nurse can administer the medication used to induce conscious sedation if the nurse meets competency requirements.
On February 5, 2007, Ms. Printy advised Board counsel that she was suspending her review of the proposed rules in light of the pending rule challenge at DOAH, referenced above.
On February 14, 2007, JAPC was notified that proposed rules 64B9- 17.001-.003 were being withdrawn. The Notice of Withdrawal was published in Volume 33, Number 8, page 3807558 of the FAW, on February 23, 2007. On March 19, 2007, Petitioners filed a Notice of Voluntary Dismissal in DOAH Case No. 07-0122, and the case was closed.
Proposed Rule 64B9-8.005: December 2008-September 2011
On December 5, 2008, the Board published a Notice of Rule Development in Volume 34, Number 49, page 6495719, in the FAW. The Notice stated that the Purpose and Effect was "to establish professional guidelines for the administration of conscious sedation and to update the instances of unprofessional conduct," citing section 464.006 as specific authority and section 464.018 as the law implemented. No preliminary draft rule was published with the notice.
A Notice of Proposed Rule was published on February 27, 2009, in Volume 35, Number 8, page 6828720 of the FAW. The Notice indicated that the Purpose and Effect of the proposed changes were to "revise the rule title and to eliminate actions that constitute violations of specific provisions of Chapters 464 and 456, F.S." The proposed amendments changed the rule name from "Disciplinary Proceedings" to "Unprofessional Conduct" and eliminated a host of violations previously included in the rule.
The proposed amendment to rule 64B9-8.005 was noticed for a public hearing to be held April 1, 2009, and the rule became effective on April 28, 2009.
Shortly thereafter, on May 1, 2009, the Board published a Notice of Rule Development in Volume 35, Number 17, page 7057834 of the FAW. The Notice indicated that "the Board proposes the development of rule amendments to address unprofessional conduct with regard to nurses." The text of the proposed rule development was not available, and no mention was made of conscious sedation.
In the meantime, the Legislature considered and passed chapter 2009-168, Laws of Florida, amending section 464.019, with respect to the approval of nursing programs. The bill, which was approved by the Governor on June 11, 2009, and became effective July 1, 2009, substantially changed the provisions of section 464.019, and provided in part:
(7) The board does not have any rulemaking authority to administer this section, except that the board shall adopt a rule that prescribes the format for submitting program applications under subsection (1) and submitting summary descriptions of program compliance under paragraph (2)(c). The board may not impose any condition or requirement on an institution submitting a program application, an approved program, or a program on probationary status except as expressly provided in this section. The board shall repeal all rules, or portions thereof, in existence on July 1, 2009, that are inconsistent with this subsection.[5]
On July 2, 2009, in Volume 35, Number 26, page 7320607 of the FAW, the Board published a Notice of Proposed Rule with respect to rule 64B9-8.005. The stated Purpose and Effect of the proposed rule amendment indicated that "the proposed rule is necessary to identify unprofessional conduct as it pertains to nurses." It did not mention the term "conscious sedation."
The proposed rule stated that it was a substantial rewording of the rule text, and provided:
Unprofessional conduct shall include: Practicing beyond the scope of the licensee's license, education preparation or experience, including but not limited to: administration or monitoring the administration of any medication intended to create an altered level of consciousness that is a deeper level than moderate sedation for a surgical diagnostic or therapeutic procedure by a registered nurse or licensed practical nurse, provided:
. . . .
The remainder of the proposed rule amendment contained similar but not identical language to that proposed in the current proposed rule, establishing those circumstances when the administration of conscious sedation by a registered or licensed practical nurse would be acceptable, and establishing training requirements for certain procedures. The proposed rule eliminated all instances of unprofessional conduct previously listed that did not deal with the administration of conscious sedation.
A Notice of Change was published July 17, 2009, to correct some cross-referencing within the proposed rule. A public hearing was noticed for October 9, 2009, and on March 19, 2010, in Volume 36, Number 11, page 8410693 of the FAW, the proposed rule as previously noticed was withdrawn.
That same day, a new version of proposed rule 64B9-
8.005 was noticed as a substantial rewording of the rule.
It listed under the Purpose and Effect and the Summary that "the proposed rule is to establish professional guidelines for the administration of conscious sedation and to update the instances of unprofessional conduct." The Notice changed the name of the rule back to "Disciplinary Proceedings" and again defined unprofessional conduct in terms of practicing beyond the scope of the licensee's license, educational preparation and experience, but providing specifics only with respect to the administration of conscious sedation. The proposed rule: added a restriction that propofol should only be administered by a practitioner experienced in general anesthesia and not by a registered nurse (except when the patient is continuously monitored and mechanically ventilated with a secured, artificial airway); established standards for the administration of prescribed pharmaceutical agents, including standards related to the practice setting; established training requirements; and defined
the terms "deep sedation, "general anesthesia," moderate sedation," and "immediately available."
On April 10, 2010, Marjorie Holloday, a Senior Attorney for JAPC, wrote to Board counsel regarding her review of the proposed rule. Ms. Holloday raised several questions and concerns regarding the proposed rule, including: whether it was the intent of the Board to eliminate conduct previously listed in the rule as bases for discipline as unprofessional conduct; whether the Notice of Rule Development given for the proposed rule provided adequate notice to all those who would be affected by the proposed rule; whether the proposed rule conflicted with rules of other boards; and whether the proposed rule may have an impact on small businesses, such as physicians' offices, hospitals, and surgery centers.
Notice of a public hearing on the proposed rule was published on April 30, 2010, in Volume 36, Number 17, page 8572877 of FAW, to be held June 11, 2010. The Notice indicated that the Board would hold a hearing on proposed rule 64B9-8.005. The general subject matter to be addressed was listed, not as unprofessional conduct or disciplinary proceedings, but as conscious sedation.
The proposed rule as noticed on March 19, 2010, was withdrawn on August 20, 2010. That same day a new Notice of Proposed Rulemaking with respect to rule 64B9-8.005 was
published. This version of the proposed rule changes restored the prior instances of unprofessional conduct, as well as the name of the rule, and added the provisions related to the administration of conscious sedation as section (15). The proposed rule also added to the definitions included in section
the terms "palliative sedation" and "refractory symptoms." The Purpose and Effect and Summary for the rule stated that it was to establish professional guidelines for the administration of conscious sedation and to update the instances of unprofessional conduct.
On September 17, 2010, a public hearing on the proposed rule was noticed for October 8, 2010. The notice listed the subject matter to be considered as "conscious sedation." No mention was made in the Notice of "unprofessional conduct."
On November 4, 2010, Ms. Holloday wrote to counsel for the Board, indicating that she did not agree with some of the analysis previously provided to address concerns with the proposed rule, and that some of her concerns had not been addressed. On November 4, 2010, another Notice of Change was published, correcting the omission of a "strikethrough" in the previous notice.
On November 9, 2010, Ms. Holloday wrote to Board counsel, expressing her understanding that as of November 8, 2010, the Board elected to toll the time for the filing of the
proposed rule for adoption pursuant to section 120.54(3)(e)6.
On November 22, 2010, Ms. Holloday again wrote to Board counsel supplementing her concerns with the proposed rule. Ms. Holloday referenced chapter 2010-279, Laws of Florida, and requested that counsel review the criteria set forth in chapter 2010-279, section 2, and advise whether the rule would need ratification by the Legislature pursuant to section 120.541(3), and whether a statement of estimated regulatory costs was now required.
A public hearing was noticed in the FAW on December 23, 2010, to take place February 4, 2011, listing proposed rule 64B9-
8.005 and the general subject matter, "conscious sedation."
On December 21, 2010, Ms. Holloday notified Board counsel that JAPC staff was considering recommending an objection to the proposed rule at a February 2011 committee meeting.
On February 11, 2011, counsel wrote to Ms. Holloday, notifying her that the Board determined that the rule amendments would not have an adverse impact on small businesses, or directly or indirectly increase regulatory costs in excess of $200,000 in the aggregate within one year of implementation. The letter also notified Ms. Holloday that the Board did not believe that the rule would require legislative ratification.
On March 7, 2011, Ms. Holloday wrote to Board counsel memorializing JAPC's staff's concerns regarding the proposed rule, to which staff anticipated recommending an objection at the
next JAPC meeting. On March 20, 2011, a copy of the JAPC agenda for March 28, 2011, was provided to the Chair of the Board, as well as counsel and other officials at the Department.
On March 29, 2011, the Chair of the Board was notified by letter that JAPC had objected to proposed rule 64B9-8.005(15). The Objection Report was attached to the letter.
After a series of communications between JAPC staff and Board counsel, on September 30, 2011, in Volume 37, Number 39, page 10438963, proposed rule 64B9-8.005, as noticed August 20, 2010, was withdrawn.
The Current Proposed Amendments to Rule 64B9-8.005
On October 7, 2011, the Board noticed proposed rule 64B9-8.005 in Volume 37, Number 40, page 10484359 of the FAW. As noticed, the stated Purpose and Effect of the proposed rule is to "establish professional guidelines for the administration of conscious sedation and to update the instances of unprofessional conduct." The Summary is similar. With respect to the Summary of Statement of Estimated Regulatory Cost, the notice provided:
During discussion of the economic impact of this rule at its Board meeting, the Board, based upon the expertise and experience of its members, determined that a Statement of Estimated Regulatory Cost (SERC) was not necessary and that these rule amendments will not require ratification by the Legislature. No person or interested party submitted additional information regarding the economic impact at that time. The Board has determined that this will not
have an adverse impact on small business, or likely increase regulatory costs in excess of $200,000 in the aggregate within
1 year after implementation of the rule.
Any person who wishes to provide information regarding the statement of estimated costs, or to provide a proposal for a lower regulatory cost alternative must do so in writing within 21 days of this notice.
The Notice identifies the date on which the Notice of Proposed Rule Development was published in the FAW as May 1, 2009. Rulemaking authority is listed as sections 464.006 and 464.018(1)(h), and the law implemented is listed as section 464.018(1)(h).
Section 464.018(1)(h) provides that "unprofessional conduct, as defined by board rule" constitutes grounds for denial of a license or for disciplinary action against a licensee. There is no mention in section 464.018 of conscious sedation.
The text of the proposed rule as noticed on October 7, 2011, is as follows:
64B9-8.005 Unprofessional Conduct.
through (12) No change.
(13)(14) Using force against a patient, striking a patient, or throwing objects at a patient;
(14)(15) Using abusive, threatening or foul language in front of a patient or directing such language toward a patient;
(15)(13) Practicing beyond the scope of the licensee's license, educational
preparation or nursing experience;, including but not limited to: administration or monitoring the administration of any medication intended to create an altered level of consciousness that is a deeper level than moderate sedation for a surgical, diagnostic or therapeutic procedure by a registered nurse or licensed practical nurse; provided:
A registered nurse may, pursuant to a duly authorized practitioner's order, administer or monitor the administration of medications to achieve deep sedation: a) to a patient as part of a life or limb threatening situation when a practitioner who has demonstrated competence in emergency airway management is physically present with the patient; or b) to a patient who is continuously monitored and mechanically ventilated with a secured, artificial airway. Examples of medications used for deep sedation in this situation include, but are not limited to, propofol, pentothal and etomidate. Due to the potential for rapid, profound changes in sedative/anesthetic depth and the lack of antagonist medications, even if moderate sedation is intended, patients receiving propofol should receive care consistent with that required for deep sedation. Therefore the administration of propofol should only be performed by a practitioner qualified by training and education in the administration of general anesthesia or in a hospital licensed under Chapter 395, Florida Statutes by a duly authorized practitioner credentialed by that hospital to administer deep sedation and not by a registered nurse, with the exception of those limited instances outlined in this rule. When a physician is actively managing a patient's sedation, a registered nurse may monitor the patient under circumstances that may include both moderate and deep sedation.
A registered nurse may administer prescribed pharmacologic agents to non- mechanically ventilated patients for the
purpose of moderate sedation in anticipation of anxiety and or discomfort during a time- limited surgical, diagnostic or therapeutic procedure. The registered nurse must continuously monitor the patient throughout the procedure and have no other responsibilities that would require leaving the patient unattended or would compromise continuous monitoring during the procedure. The registered nurse must document the patient's level of consciousness at least every five minutes during the procedure. In the event a deeper level of sedation (such as deep sedation or general anesthesia) unintentionally results from the administration of prescribed pharmacologic agents, the procedure must be stopped and the level of sedation returned to moderate sedation with the assistance of the prescribing physician or credentialed anesthesia provider.
A registered nurse or licensed practical nurse may, pursuant to duly authorized practitioner order, administer or monitor the administration of medications for palliative sedation in a hospice program.
In order to administer or monitor any pharmacologic agents in accordance with subsection (a) or (b) above, a registered nurse must:
Prior to any administration or monitoring of any pharmacologic agents, successfully demonstrate competence which reflects the extent of privileges requested, including a criteria-based competency evaluation. At a minimum, the competency demonstration will include: education in pharmacology and physiology, physical assessment and monitoring techniques, airway anatomy, airway management techniques and an opportunity for skill development. The evaluative criteria will cover knowledge and psychomotor skills in assessment and monitoring, principles of pharmacodynamics and pharmacokinetics (onset, duration, distribution, metabolism, elimination,
intended and adverse effects, interactions, dosages and contraindications), basic and difficult airway management, mechanical ventilation, and cardiopulmonary resuscitation. The registered nurse must also be certified in advanced cardiac life support;
Complete a patient assessment and ensure that the practice setting requires that the physician prescribing the pharmacologic agent has evaluated the patient based on established criteria;
Pharmacologic agents that may be administered by a registered or practical nurse pursuant to paragraphs (b) and (c) shall not include medications that are intended to result in loss of consciousness such as propofol, penthothal, dexmedetomidine, or any medication which the manufacturer's package insert states should be administered only by individuals trained in the administration of general anesthesia.
Ensure that the practice setting requires that the prescribing practitioner, or in a hospital licensed under Chapter 395, Florida Statutes, a practitioner who has demonstrated competence in emergency airway management is physically present throughout the procedure and immediately available during the recovery period unless the patient is mechanically ventilated;
Ensure that written policies and procedures for managing patients who receive moderate sedation are reviewed periodically and are readily available within the practice setting;
Ensure that the practice setting has in place a quality assurance and performance improvement process that measures patient, process and structural outcome indicators; and
Evaluate the patient for discharge readiness based on specific discharge criteria and ensure that the practice setting requires that the physician approves of the patient discharge.
Administration or monitoring of the administration of medication to achieve sedation at any level under the circumstances set forth in this rule is beyond the scope of practice of licensed practical nurses.
The following definitions apply for purposes of this rule:
Deep sedation means a medication- induced depression of consciousness that allows patients to respond purposefully only after repeated or painful stimulation. The patient cannot be aroused easily, and the ability to maintain a patent airway independently may be impaired with spontaneous ventilation possibly inadequate. Cardiovascular function usually is adequate and maintained.
General anesthesia means the patient cannot be aroused, even by painful stimulation, during this medication-induced loss of consciousness. Patients usually require assistance in airway maintenance and often require positive pressure ventilation due to depressed spontaneous ventilation or depression of neuromuscular function.
Cardiovascular function may also be impaired.
Moderate sedation means a minimally depressed level of consciousness that allows a surgical patient to retain the ability to maintain a patent airway independently and continuously and respond appropriately to verbal commands and physical stimulation.
Immediately available means having a health care provider trained in advanced cardiac life support and resuscitation skills available to assist with patient care within five minutes.
Palliative sedation means the use of medications intended to provide relief of intractable or refractory symptoms by inducing varying degrees of unconsciousness in imminently dying patients.
Refractory symptoms means symptoms that cannot be adequately controlled in a tolerable time frame despite use of
alternate therapies, and seem unlikely to be controlled by further invasive or noninvasive therapies without excessive or intolerable acute or chronic side effects or complications.
On October 21, 2011, in Volume 37, Number 42, page 10545566 of the FAW, the proposed rule was noticed for a public hearing to be conducted on December 2, 2011, in Dania Beach, Florida. The notice identified the rule number and rule title as rule 64B9-8.005: Unprofessional Conduct, and provided that the general subject matter to be considered was conscious sedation.
On October 17, 2011, Ms. Holloday wrote to Board counsel regarding her review of the proposed rule as noticed October 7, 2011. Her review included the following statements regarding the rule:
Please explain whether education in the topics enumerated in this rule text is the exclusive method of demonstrating competence to administer or monitor pharmaceutical agents to achieve deep or moderate sedation. If so, this language, like the language in the rule to which the Committee objected on March 28, 2011, does not appear to allow a registered nurse to demonstrate competency by training or experience. This may, in effect, establish separate and specific education and training requirements to practice professional nursing, creating an unauthorized level of licensure for registered nurses, thereby enlarging upon the provisions of the Nurse Practice Act by requiring educational courses not otherwise required by subsection 464.003(2), Florida Statutes. See § 120.52(8)(c), Fla. Stat.
Further, section 464.018, Florida Statutes, is entitled "Disciplinary actions," and paragraph 464.018(1)(h), Florida Statutes, provides that acts of "unprofessional conduct," as provided by board rule may subject a licensee to disciplinary action. Requiring an unauthorized level of licensure, by board rule, is not "unprofessional conduct," which could subject registered nurses to disciplinary action. It does not appear that rule subparagraph [(15)](d)1. is necessary to accomplish the apparent or expressed objectives of paragraph 464.018(1)(h), Florida Statutes, cited as the law implemented. See § 120.545(1)(g), Fla.
Stat.
Paragraph (15)(d)3. of the proposed rule as noticed October 7, 2011, prohibits registered or licensed practical nurses from administering pharmacological agents that are intended to result in loss of consciousness, such as propofol, penthothal, dexmedetomidine, or any medication which the manufacturer's package insert states should be administered only by individuals trained in the administration of general anesthesia. With respect to this paragraph, Ms. Holloday's review stated:
As you are aware, similar language was contained in the proposed rule to which the Committee voted an objection on March 28, 2011.
Your letter dated September 21, 2011, stated, "[T]he Board will not amend the rule with regard to the prohibitions of administration of identified medications.
The Board respectfully disagrees with the
Committee's interpretation of Sections 464.003(20) and 458.303(2), Florida
Statutes." Please explain how the Board disagrees with the Committee's interpretation of Section 464.003(20), Florida Statutes.
* * *
As subsection 464.003(20) establishes the registered nurse's statutory scope of practice, it appears this prohibition is not consistent with the expressed legislative intent stated in subsection 456.003(6), Florida Statutes, which states:
Unless expressly and specifically granted in statute, the duties conferred on the boards do not include the enlargement, modification, or contravention of the lawful scope of practice of the profession regulated by the boards. This subsection shall prohibit the boards, or the department when there is no board, from taking disciplinary action or issuing a declaratory statement.
Changing the statutory scope of practice of a registered nurse by rule is not "unprofessional conduct" and is not consistent with the legislative intent of sections 456.003(6) and 464.018(1)(h), Florida Statutes. See § 120.545(1)(f), Fla. Stat.
On December 21, 2011, counsel for the Board wrote Ms. Holloday to advise her that the Board had considered her comments at its public hearing on December 2, 2011. Counsel advised that some changes would be made to the rule to address
some of the objections stated, but that the Board disagreed with
her conclusion that the rule was requiring an unauthorized level of licensure, and that registered nurses who administer the identified drugs should not be subject to disciplinary action.
On December 16, 2011, in Volume 37, Number 50, page 10781567 of the FAW, the Board published a Notice of Public Hearing, scheduled for February 3, 2012, identifying rule 64B9-
8.005. The general subject matter to be considered was listed as "unprofessional conduct."
On March 22, 2012, Ms. Holloday again wrote to Board counsel regarding proposed amendments to rule 64B9-8.005, asking about whether several identified changes had been made to the rule and whether the Board still intended to make those changes. Ms. Holloday also questioned the Board's conclusion that a statement of estimated regulatory costs was unnecessary,
stating:
The rule requires registered nurses, who administer medications to achieve sedation, to demonstrate competency pursuant to the provisions of rule subparagraph (15)(d)1.
That rule subparagraph requires the registered nurse to successfully demonstrate competence which reflects the extent of privileges requested, including a criteria- based competency evaluation. The competency demonstration, at a minimum, includes certain educational requirements. The registered nurse is also required to be certified in advanced cardiac life support.
* * *
The costs of this competency demonstration and the certification in advanced cardiac life support will be incurred by someone. The nurse, the nurse's employer, and/or a facility, will be required to cover the costs of this education, training, evaluation, and certification. It appears that the economic impact of this rule should include consideration of the number of persons and entities that will be impacted financially. Likewise, it appears that the economic impact of this rule should take into consideration how much this education, training, evaluation, and certification will cost. Please explain whether the Board considered the direct and indirect increased regulatory costs imposed by this rule.
The letter also reiterated that the rule amendments did not appear to be appropriate in a rule defining "unprofessional conduct."
On April 6, 2012, in Volume 38, Number 14, page 11336310 of the FAW, the Board published a Notice of Change with respect to the proposed rule, stating that the changes were proposed due to concerns by JAPC in its letter dated October 17, 2011. The Notice published changes to paragraph (15), but did not identify what specific changes were made. The Notice provided that, "[w]hen changed, the proposed subsection (15)
shall read:"
(15) Practicing beyond the scope of the
licensee's license, educational preparation or nursing experience, including but not limited to: administration or monitoring by a registered nurse or licensed practical nurse of the administration of any medication intended to create moderate or
deep sedation for a surgical, diagnostic or therapeutic procedure; provided:
A registered nurse may, pursuant to a duly authorized practitioner's order, administer or monitor the administration of medications to achieve deep sedation: 1) to a patient as part of a life or limb threatening situation when a practitioner who has demonstrated competence in emergency airway management is physically present with the patient; or 2) to a patient who is continuously monitored and mechanically ventilated with a secured, artificial airway. Examples of medications used for deep sedation in this situation include, but are not limited to, propofol, penthothal and etomidate. Due to the potential for rapid, profound changes in sedative/anesthetic depth and the lack of antagonist medications, even if moderate sedation is intended, patients receiving propofol shall receive care consistent with that required for deep sedation. Therefore the administration of propofol shall not be performed by a licensee who is not a duly authorized practitioner with the exception of those limited instances outlined in this rule. When a duly authorized practitioner is actively managing a patient's sedation, a registered nurse may monitor the patient under deep sedation.
A registered nurse may administer prescribed pharmacologic agents to mechanically ventilated and non-mechanically ventilated patients for the purpose of moderate sedation in anticipation of anxiety and or discomfort during a time-limited surgical, diagnostic or therapeutic procedure. The registered nurse must continuously monitor the patient throughout the procedure and have no other responsibilities that would require leaving the patient unattended or would compromise continuous monitoring during the procedure. The registered nurse must document the non- mechanically ventilated patient's level of consciousness at least every five minutes
during the procedure. In the event a deeper level of sedation (such as deep sedation or general anesthesia) unintentionally results from the administration of prescribed pharmacologic agents to the non-mechanically ventilated patient, the registered nurse must immediately notify the duly authorized practitioner and document the actions taken until the patient's level of sedation returned to moderate sedation with the assistance of the duly authorized practitioner. Pharmacologic agents that may be administered by a registered nurse pursuant to this subsection shall not include medications that [are] intended to result in loss of consciousness such as propofol, penthothal, etomidate, or any medication which the manufacturer's package insert states should be administered only by individuals trained in the administration of general anesthesia. When a duly authorized practitioner is actively managing a patient's sedation, a registered nurse may monitor the patient under moderate sedation.
A registered nurse or licensed practical nurse may, pursuant to duly authorized practitioner's order, administer or monitor the administration of medications for palliative sedation in a hospice program.
In order to administer or monitor any pharmacologic agents to achieve deep sedation in accordance with paragraph (a) above, a registered nurse must:
Prior to any administration or monitoring of any pharmacologic agents, successfully demonstrate competence which reflects the extent of privileges requested, including a criteria-based competency evaluation. The evaluative criteria for the competency demonstration will cover knowledge and psychomotor skills in physical assessment and monitoring of sedated patients, principles of pharmacodynamics and pharmacokinetics (onset, duration, distribution, metabolism, elimination, intended and adverse effects, interactions,
dosages and contraindications) of the pharmacologic agents being administered or monitored, basic and difficult airway management, mechanical ventilation, and cardiopulmonary resuscitation. The registered nurse must also be certified in advanced cardiac life support that is appropriate for the patient's age;
Complete a patient assessment and ensure that the practice setting requires that the duly authorized practitioner prescribing the pharmacologic agent has evaluated the patient based on established criteria;
Ensure that the practice setting requires that the prescribing practitioner, or in a hospital licensed under Chapter 395, Florida Statutes, a practitioner who has demonstrated competence in emergency airway management is physically present throughout the procedure and immediately available during the recovery period unless the patient is mechanically ventilated;
Ensure that the practice setting has in place a quality assurance and performance improvement process that measures patient, process and structural outcome indicators; and
Evaluate the patient for discharge readiness based on specific discharge criteria and ensure that the practice setting requires that the physician approves of the patient discharge.
In order to administer or monitor any pharmacologic agents to achieve moderate sedation in accordance with subsection (b) above, a registered nurse must:
Ensure that the practice setting requires that the prescribing practitioner, or in a hospital licensed under Chapter 395, Florida Statutes, a practitioner who has demonstrated competence in emergency airway management is physically present throughout the procedure and immediately available during the recovery period unless the patient is mechanically ventilated;
Ensure that written policies and procedures for managing patients who receive moderate sedation are reviewed periodically and are readily available within the practice setting;
Ensure that the practice setting has in place a quality assurance and performance improvement process that measures patient, process and structural outcome indicators; and
Evaluate the patient for discharge readiness based on specific discharge criteria and ensure that the practice setting requires that the physician approves of the patient discharge.
Administration or monitoring of the administration of medication to achieve moderate or deep sedation is beyond the scope of practice of licensed practical nurses, except as described in paragraph (c) above.
The following definitions apply for purposes of this rule:
Deep sedation means a medication- induced depression of consciousness that allows patients to respond purposefully only after repeated or painful stimulation. The patient cannot be aroused easily, and the ability to maintain a patent airway independently may be impaired with spontaneous ventilation possibly inadequate. Cardiovascular function usually is adequate and maintained.
General anesthesia means the patient cannot be aroused, even by painful stimulation, during this medication-induced loss of consciousness. Patients usually require assistance in airway maintenance and often require positive pressure ventilation due to depressed spontaneous ventilation or depression of neuromuscular function. Cardiovascular function may also be impaired.
Moderate sedation means a minimally depressed level of consciousness that allows a patient to retain the ability to maintain a patent airway independently and
continuously and respond appropriately to verbal commands and physical stimulation.
Immediately available means having a health care provider trained in advanced cardiac life support and resuscitation skills available to assist with patient care within five minutes.
Palliative sedation means the use of medications intended to provide relief of intractable or refractory symptoms by inducing varying degrees of unconsciousness in imminently dying patients.
Refractory symptoms means symptoms that cannot be adequately controlled in a tolerable time frame despite use of alternate therapies, and seem unlikely to be controlled by further invasive or noninvasive therapies without excessive or intolerable acute or chronic side effects or complications.
Duly authorized practitioner means a physician licensed under Chapter 458 or Chapter 459, a dentist licensed under Chapter 466 who is authorized to order and administer anesthesia or sedation, a podiatrist who is authorized under Chapter 461, a certified registered nurse anesthetist authorized under Chapter 464, and by protocol to order and administer anesthesia or sedation, or a certified nurse midwife authorized under Chapter 464 and by protocol to order or administer anesthetics.
As stated, the Notice of Change as published contains no "strike through" or underlining to delineate the changes to the proposed rule, which is required pursuant to Florida Administrative Code Rule 1-1.011(5)(f). However, a comparison of the rule as published October 7, 2011, compared to the Notice of Change published April 6, 2012, reveals the following:
(15)(13) Practicing beyond the scope of the licensee's license, educational preparation or nursing experience;, including but not limited to: administration or monitoring by a registered nurse or licensed practical nurse of the administration of any medication intended to create an altered level of consciousness that is a deeper level than moderate or deep sedation for a surgical, diagnostic or therapeutic procedure by a registered nurse or licensed practical nurse; provided:
A registered nurse may, pursuant to a duly authorized practitioner's order, administer or monitor the administration of medications to achieve deep sedation: a) to a patient as part of a life or limb threatening situation when a practitioner who has demonstrated competence in emergency airway management is physically present with the patient; or b) to a patient who is continuously monitored and mechanically ventilated with a secured, artificial airway. Examples of medications used for deep sedation in this situation include, but are not limited to, propofol, pentothal and etomidate. Due to the potential for rapid, profound changes in sedative/anesthetic depth and the lack of antagonist medications, even if moderate sedation is intended, patients receiving propofol should receive care consistent with that required for deep sedation. Therefore the administration of propofol shall not be should only be performed by a licensee who is not a duly authorized practitioner practitioner qualified by training and education in the administration of general anesthesia or in a hospital licensed under Chapter 395, Florida Statutes by a duly authorized practitioner credentialed by that hospital to administer deep sedation and not by a registered nurse, with the exception of those limited instances outlined in this rule. When a physician is actively managing a patient's sedation, a registered nurse may
monitor the patient under circumstances that may include both moderate and deep sedation.
A registered nurse may administer prescribed pharmacologic agents to non- mechanically ventilated patients for the purpose of moderate sedation in anticipation of anxiety and or discomfort during a time- limited surgical, diagnostic or therapeutic procedure. The registered nurse must continuously monitor the patient throughout the procedure and have no other responsibilities that would require leaving the patient unattended or would compromise continuous monitoring during the procedure. The registered nurse must document the non- mechanically ventilated patient's level of consciousness at least every five minutes during the procedure. In the event a deeper level of sedation (such as deep sedation or general anesthesia) unintentionally results from the administration of prescribed pharmacologic agents to the non-mechanically ventilated patient, the registered nurse must immediately notify the duly authorized practitioner and document the actions taken until , the procedure must be stopped and the level of sedation returned to moderate sedation with the assistance of the prescribing physician or credentialed anesthesia provider duly authorized practitioner. Pharmacologic agents that may be administered by a registered nurse pursuant to this subsection shall not include medications that intended to result in loss of consciousness such as propofol, penthathol, etomidate, or any medication which the manufacturer's package insert states should be administered only by individuals trained in the administration of general anesthesia. When a duly authorized practitioner is actively managing a patient's sedation, a registered nurse may monitor the patient under moderate sedation.
A registered nurse or licensed practical nurse may, pursuant to duly authorized practitioner order, administer or monitor the administration of medications
for palliative sedation in a hospice program.
In order to administer or monitor any pharmacologic agents to achieve deep sedation in accordance with paragraph(a) subsection (a) or (b) above, a registered nurse must:
Prior to any administration or monitoring of any pharmacologic agents, successfully demonstrate competence which reflects the extent of privileges requested, including a criteria-based competency evaluation. At a minimum, the competency demonstration will include: education in pharmacology and physiology, physical assessment and monitoring techniques, airway anatomy, airway management techniques and an opportunity for skill development. The evaluative criteria for the competency demonstration will cover knowledge and psychomotor skills in assessment and monitoring of sedated patients, principles of pharmacodynamics and pharmacokinetics (onset, duration, distribution, metabolism, elimination, intended and adverse effects, interactions, dosages and contraindications) of the pharmacologic agents being administered or monitored, basic and difficult airway management, mechanical ventilation, and cardiopulmonary resuscitation. The registered nurse must also be certified in advanced cardiac life support that is appropriate for the patient's age;
Complete a patient assessment and ensure that the practice setting requires that the duly authorized practitioner physician prescribing the pharmacologic agent has evaluated the patient based on established criteria;
Pharmacologic agents that may be administered by a registered or practical nurse pursuant to paragraphs (b) and (c) shall not include medications that are intended to result in loss of consciousness such as propofol, penthothal, dexmedetomidine, or any medication which the
manufacturer's package insert states should be administered only by individuals trained in the administration of general anesthesia.
Ensure that the practice setting requires that the prescribing practitioner, or in a hospital licensed under Chapter 395, Florida Statutes, a practitioner who has demonstrated competence in emergency airway management is physically present throughout the procedure and immediately available during the recovery period unless the patient is mechanically ventilated;
Ensure that written policies and procedures for managing patients who receive moderate sedation are reviewed periodically and are readily available within the practice setting;
46. Ensure that the practice setting has in place a quality assurance and performance improvement process that measures patient, process and structural outcome indicators; and
Evaluate the patient for discharge readiness based on specific discharge criteria and ensure that the practice setting requires that the physician approves of the patient discharge.
In order to administer or monitor any pharmacologic agents to achieve moderate sedation in accordance with subsection (b) above, a registered nurse must:
Ensure that the practice setting requires that the prescribing practitioner, or in a hospital licensed under Chapter 395, Florida Statutes, a practitioner who has demonstrated competence in emergency airway management is physically present throughout the procedure and immediately available during the recovery period unless the patient is mechanically ventilated;
Ensure that written policies and procedures for managing patients who receive moderate sedation are reviewed periodically and are readily available within the practice setting;
Ensure that the practice setting has in place a quality assurance and performance
improvement process that measures patient, process and structural outcome indicators; and
Evaluate the patient for discharge readiness based on specific discharge criteria and ensure that the practice setting requires that the physician approves of the patient discharge.
(f)(e) Administration or monitoring of the administration of medication to achieve moderate or deep sedation at any level under the circumstances set forth in this rule is beyond the scope of practice of licensed practical nurses, except as described in paragraph (c) above..
(g)(f) The following definitions apply for purposes of this rule:
Deep sedation means a medication- induced depression of consciousness that allows patients to respond purposefully only after repeated or painful stimulation. The patient cannot be aroused easily, and the ability to maintain a patent airway independently may be impaired with spontaneous ventilation possibly inadequate. Cardiovascular function usually is adequate and maintained.
General anesthesia means the patient cannot be aroused, even by painful stimulation, during this medication-induced loss of consciousness. Patients usually require assistance in airway maintenance and often require positive pressure ventilation due to depressed spontaneous ventilation or depression of neuromuscular function. Cardiovascular function may also be impaired.
Moderate sedation means a minimally depressed level of consciousness that allows a surgical patient to retain the ability to maintain a patent airway independently and continuously and respond appropriately to verbal commands and physical stimulation.
Immediately available means having a health care provider trained in advanced cardiac life support and resuscitation
skills available to assist with patient care within five minutes.
Palliative sedation means the use of medications intended to provide relief of intractable or refractory symptoms by inducing varying degrees of unconsciousness in imminently dying patients.
Refractory symptoms means symptoms that cannot be adequately controlled in a tolerable time frame despite use of alternate therapies, and seem unlikely to be controlled by further invasive or noninvasive therapies without excessive or intolerable acute or chronic side effects or complications.
Duly authorized practitioner means a physician licensed under Chapter 458 or Chapter 459, a dentist licensed under Chapter 466 who is authorized to order and administer anesthesia or sedation, a podiatrist who is authorized under Chapter 461, a certified registered nurse anethestist authorized under Chapter 464, and by protocol to order and administer anesthesia or sedation, or a certified nurse midwife authorized under Chapter 464 and by protocol to order or administer anesthetics.
On April 18, 2012, notice of a rules hearing to be conducted May 11, 2012, was forwarded to JAPC.
On April 25, 2012, Petitioners filed the Petition for Administrative Determination of Invalidity of Proposed Rule at the Division of Administrative Hearings, which gave rise to these proceedings.
On April 27, 2012, in Volume 38, Number 17, page 11418954 of the FAW, the Board published the Notice of Public Hearing, referenced in paragraph 58 above, scheduling a public hearing on proposed rule 64B9-8.005, as noticed on October 7,
2011, for May 11, 2012, in Fort Lauderdale. The subject matter to be considered was listed as "Unprofessional Conduct."
Although Petitioners submitted the documents from JAPC regarding the adoption process, the rulemaking record of the Board has not been submitted by any participant in this proceeding.
No evidence was submitted suggesting that any party submitted a lower cost regulatory alternative to proposed rule 64B9-8.005.
Standing
Petitioners are substantially affected by the proposed rule. Licensed allopathic, osteopathic, and podiatric physicians, whose interests Petitioners represent, are specifically defined as duly-authorized practitioners in the April changes to the proposed rule. The rule, as proposed, affects the safety of patients treated by allopathic, osteopathic, and podiatric physicians when moderate to deep sedation is required. Patient safety is also the basis asserted for standing by FANA. As an example, with respect to patient safety, Dr. Joshua Lenchus, D.O. (a member of both the FMA or the FOMA), was asked how the rule would affect him, and he referred specifically to paragraph (15)(e), saying:
. . . . It has an effect on me as a registered nurse insuring that the practice setting requires, et cetera. I don't know
how that would be logistically implemented or operationalized.
That could potentially cause a delay in the performance of a procedure on a patient, or the cancellation of a procedure on a patient, or untoward harm on a patient due to the lack of provision of that level of sedation.
Q. Do you believe that this paragraph one requires something more than someone there who has demonstrated competency in airway management?
A. As I read paragraph one, the first four words indicate that a registered nurse must do these things. If a registered nurse must insure what the practice setting requires, that seems to me that it is not sufficient enough that the setting has a practitioner who has demonstrated competence, but that the registered nurse is going to be held to insure that the practice setting requires that.
* * *
So the way that I read it -- you asked about me, personally, -- the way that I interpret that is that could cause a significant delay, revision of policies, hiring of different staff, creation of a different policy and procedure manual. It can ensue in a host of things that can lead to patient delay, harm the provision of services, et cetera.
Nurses do not perform the functions described in the rule in a vacuum. Examples of physicians whose specialties would be substantially affected by the proposed rule are gastroenterologists, pulmonologists, hospitalists, internists, pediatricians, critical care physicians, and emergency room
physicians. These specialists, among others, would be affected by the provisions of the proposed rule because these fields have the ability to use moderate sedation in the performance of procedures in the normal clinical context of their daily practice. Prohibiting or restricting registered nurses from being involved in the administration or monitoring of sedative agents would affect who these practitioners would be able to employ and/or what procedures could be performed with the use of existing staff. Whether they currently use CRNAs as opposed to registered nurses is beside the point: their present and future practices clearly would be affected by the scope of practice that could be performed by employees involved in the administration of conscious sedation.
According to Dr. Lenchus, based upon those members of the FMA that indicate a specialty, at least one third of the FMA's members are in specialty areas that routinely would use sedation in their practices. With respect to FOMA, the top four areas of specialty, all of which routinely use conscious sedation, comprise approximately 50 percent of the organization's membership. Mr. Schwartz testified that, with respect to the FPMA, approximately 50-70 percent of its members have practices with a surgical component that would put them in a position to utilize conscious sedation.
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction over the subject matter and the parties to this action in accordance with sections 120.56, 120.569 and 120.57(1), Florida Statutes.
Standing
Petitioners and both Intervenors have standing to participate in this case. Section 120.56 allows a person who is substantially affected by a rule or agency statement to initiate a challenge. To establish standing under the "substantially affected" test, generally a party must demonstrate that: 1) the rule will result in a real and immediate injury in fact, and
2) the alleged interest is within the zone of interest to be protected or regulated. Jacoby v. Fla. Bd. of Med., 917 So. 2d
358 (Fla. 1st DCA 2005); see also Fla. Bd. of Med. v. Fla. Acad. of Cosmetic Surgery, 808 So. 2d 243, 250 (Fla. 1st DCA 2002), superseded on other grounds, Dep't of Health v. Merritt, 919
So. 2d 561 (Fla. 1st DCA 2006).
Petitioners and Intervenors are all professional associations. With respect to associational standing, the Supreme Court of Florida has stated that to meet the requirements of section 120.56(1), an association must demonstrate that a substantial number of its members, although not necessarily a majority, are "substantially affected" by the
challenged rule. The subject matter of the rule must be within the association's general scope of interest and activity, and the relief requested must be of the type appropriate for a trade association to receive on behalf of its members. NAACP, Inc. v. Bd. of Regents, 863 So. 2d 294, 298 (Fla. 2003); Florida Home
Builders Ass'n v. Dep't of Labor and Emp. Sec., 412 So. 2d 351 (Fla. 1982). That standard has been met here. All five associations represent licensees, either of physicians of different types, or nurses, in Florida. The physicians Petitioners represent are identified as authorized providers in the proposed rule. They are the providers who order the administration of the sedation in question, and whose patients are receiving the sedation. The subject matter is within the Petitioners' general scope of interest and the relief sought is appropriate.
In Rosenzweig v. Department of Transportion, 979 So.
2d 1050, 1054 (Fla. 1st DCA 2008), a group of cyclists challenged a DOT decision not to include cycling lanes on a state road project. The Department determined that the cyclists did not have standing to challenge its interpretation of section 335.065, Florida Statutes, and the First District disagreed,
stating,
Considering the APA's policy, the supreme court's decision in NAACP, and the factors enunciated in Agrico [Chemical Co. v.
Department of Environmental Regulation, 406 So. 2d 478, 482 (Fla. 2d DCA 1981)], it is
clear that if anyone has the ability to challenge the Department's interpretation of section 335.065, which specifically relates to bicycle lanes, it would be those seriously involved in bicycling.
The same can be said here. Proposed rule 64B9-8.005 clearly establishes standards for the administration of conscious sedation. Petitioners represent the authorized providers specifically listed in the proposed rule as those authorized to order the administration of conscious sedation. Other than nurses, if anyone has standing to challenge the Board's proposed rule it would be those authorized to order the administration of conscious sedation for which the Board is creating these standards.
FANA's Motion to Dismiss and for Summary Final Order
FANA argues, and the Board and FNA agree, that Petitioners' challenge ought to be dismissed for lack of jurisdiction, or in the alternative, should be limited to those changes to the proposed rule noticed on April 6, 2012. FANA bases its argument on the undisputed fact that the Petition in this case was filed within 20 days of the Notice of Change published April 6, 2012, as opposed to within 21 days of the publication of the Notice of Proposed Rule in October 2011.
Section 120.56(2)(a), provides:
(a) A substantially affected person may seek an administrative determination of the invalidity of a proposed rule by filing a petition seeking such a determination with the division within 21 days after the date of publication of the notice required by s. 120.54(3)(a); within 10 days after the final public hearing is held on the proposed rule as provided by s. 120.54(3)(e)2.; within 20 days after the statement of estimated regulatory costs or revised statement of estimated regulatory costs, if applicable, has been prepared and made available as provided in s. 120.541(1)(d); or within 20 days after the date of publication of the notice required by s. 120.54(3)(d). The petition must state with particularity the objections to the proposed rule and the reasons that the proposed rule is an invalid exercise of delegated legislative authority. The petitioner has the burden of going forward. The agency then has the burden to prove by a preponderance of the evidence that the proposed rule is not an invalid exercise of delegated legislative authority as to the objections raised. A person who is substantially affected by a change in the proposed rule may seek a determination of the validity of such change. A person who is not substantially affected by the proposed rule as initially noticed, but who is substantially affected by the rule as a result of a change, may challenge any provision of the rule and is not limited to challenging the change of the proposed rule. (emphasis added).
Respondent and Intervenors do not believe Petitioners have standing to challenge the rule at all: however, assuming standing, they believe that if Petitioners are substantially affected by the proposed rule, that was true when the rule was
originally published. Given that Petitioners did not challenge the proposed rule within 21 days of publication of the proposed rule in October 2011, Respondents assert that Petitioners' challenge, if any, is limited to the changes published in the Notice of Change. They rely on the last sentence of section 120.56(2)(a).
Respondent and Intervenors acknowledge that Petitioners filed the Petition before the expiration of the time period for filing a challenge after the last public hearing. In fact, the Petition was filed between the time that JAPC received notice that a public hearing would be noticed, and notice of the final public hearing was published in the FAW, and before the public hearing itself. Respondent and Intervenors assert that the same limitation contained in section 120.56(2)(a) with respect to challenges based on a notice of change should be read into the authorization to challenge a proposed rule within 10 days after the final public hearing. In other words, they contend that the challenge should be limited to those issues addressed at the final public hearing.
Petitioners contend, on the other hand, that the final sentence in section 120.56(2)(a) should be read as an expansion of the scope of the proceedings as opposed to a limitation. In any event, Petitioners contend that the Petition was filed prior
to the deadline for filing within 10 days after the final public hearing.
Respondent and Intervenors are correct in asserting that generally, a person who is substantially affected by a proposed rule and who only challenges that rule after a notice of proposed change is limited to challenging the proposed change. As an initial inquiry, it must be determined whether Petitioners' members would have been substantially affected by the notice of rule 64B9-8.005 as originally noticed. Clearly, Petitioners' members were authorized practitioners under the rule as noticed, whether or not the rule defined them as such at the time, and they would have been substantially affected by the proposed rule before it was changed.
Given that Petitioners were substantially affected by the rule as noticed in October 2011, Petitioners would normally be limited to challenging those changes published in April 2012. However, two additional issues must be resolved: first, whether there is any distinction caused by the publication of the Notice of Change as a substantial rewording; and second, whether the normal Notice of Change limitation is affected by the fact that the final public hearing was held after the Notice of Change.
Nothing in section 120.56(2) addresses the scope of a rule challenge in the event that an agency undertakes a substantial rewording of a proposed rule in a Notice of Change.
Absent some indication by the Legislature that a different result is intended, the scope of any challenge must be interpreted based on the existing language of section 120.56(2). Given its current wording, the undersigned concludes that the scope of a challenge would have to be interpreted based upon whether the substantial rewording of the rule has the effect of converting the proposed rule into a new and different proposal or whether individual changes can be discerned from the new language. If individual changes can in fact be identified, then a person who was substantially affected by the original notice of proposed rulemaking would be limited to challenging those changes.
In this case, such an interpretation would lead to a somewhat tortured analysis of the rule to determine what is new and what is not, because some provisions are truly changed and some are simply rearranged. It is sufficient to state that the changes to the rule are woven throughout its fabric. However, an attempt to determine whether the Notice of Change is so substantial as to leave everything open to challenge is unnecessary.
Petitioners contend that the limitation in section 120.56(2)(a) is an extension rather than a restriction of the scope of what may be challenged. Such an interpretation would simply ignore the last sentence of the subsection, which is
impermissible. However, Petitioners are free to challenge the entire proposed rule, including those changes initiated in the October publication of the Notice of Proposed Rule, because they filed the rule challenge prior to the expiration of the 10-day period after the final public hearing on the rule.
Respondent and Intervenors contend that the restriction in the final sentence of section 120.56(2)(a) should also apply to the final public hearing, i.e., that the issues subject to challenge should be restricted to those discussed at the final public hearing. However, the Legislature did not provide the same limitation to the deadline for filing a challenge following the final public hearing as it did to challenges based on notices of proposed rule changes. "It is a general canon of statutory construction that, when the legislature includes particular language in one section of a statute but not in another section of the same statute, the omitted language is presumed to have been excluded intentionally." L.K. v. Dep't of Juv. Just., 917 So. 2d 919, 920 (Fla. 1st DCA 2005)(citations omitted). This principle applies here. To interpret section 120.56(2)(a) as Respondent and Intervenors suggest would be to add language to the statute that the Legislature did not include.
Even assuming that Respondent and Intervenors' interpretation were permissible, it could not be applied in this case. The notice of the public hearing did not limit the scope of issues related to the rule that could be discussed at the public hearing. It simply listed the subject matter as "unprofessional conduct." Further, there is no evidence in this proceeding to indicate what was discussed during the public hearing. In any event, absent the final public hearing, Petitioners would be limited to challenging the revisions reflected in the Notice of Change. However, Petitioners benefit from the scheduling and conduct of the final public hearing, and are free to challenge the proposed rule in its entirety, as reworded in the Notice of Change published April 6, 2012. Accordingly, FANA's Motion to Dismiss is denied.
Petitioner's Motion for Summary Final Order
Section 120.56(1)(a) provides that any person substantially affected by a proposed rule may seek an administrative determination that the rule is an invalid exercise of delegated authority. Rule challenges are de novo in nature, and while Petitioners have the burden of going forward, the agency has the burden to prove that the proposed rule is not an invalid exercise of delegated legislative authority. The standard of proof is by the preponderance of the evidence.
§ 120.56(2)(a). Proposed rules are not presumed to be valid or invalid. § 120.56(2)(c), Fla. Stat.
Section 120.52(8) defines "invalid exercise of delegated legislative authority." It provides:
"Invalid exercise of delegated legislative authority" means action that goes beyond the powers, functions, and duties delegated by the Legislature. A proposed or existing rule is an invalid exercise of delegated legislative authority if any one of the following applies:
The agency has materially failed to follow the applicable rulemaking procedures or requirements set forth in this chapter;
The agency has exceeded its grant of rulemaking authority, citation to which is required by s. 120.54(3)(a)1.;
The rule enlarges, modifies, or contravenes the specific provisions of law implemented, citation to which is required by s. 120.54(3)(a)1.;
The rule is vague, fails to establish adequate standards for agency decisions, or vests unbridled discretion in the agency;
The rule is arbitrary or capricious. A rule is arbitrary if it is not supported by logic or the necessary facts; a rule is capricious if it is adopted without thought or reason or is irrational; or
The rule imposes regulatory costs on the regulated person, county, or city which could be reduced by the adoption of less costly alternatives that substantially accomplish the statutory objectives.
A grant of rulemaking authority is necessary but not sufficient to allow an agency to adopt a rule; a specific law to be implemented is also required. An agency may adopt only rules that implement or interpret
the specific powers and duties granted by the enabling statute. No agency shall have authority to adopt a rule only because it is reasonably related to the purpose of the enabling legislation and is not arbitrary and capricious or is within the agency's class of powers and duties, nor shall an agency have the authority to implement statutory provisions setting forth general legislative intent or policy. Statutory language granting rulemaking authority or generally describing the powers and functions of an agency shall be construed to extend no further than implementing or interpreting the specific powers and duties conferred by the enabling statute.
Petitioners challenge proposed rule 64B9-8.005 as an invalid exercise of delegated legislative authority on the following grounds: 1) whether the Board complied with the applicable rulemaking procedures in chapter 120, as defined in section 120.52(8)(a); 2) whether the Board exceeded its grant of rulemaking authority, as defined in section 120.52(8)(b); 3) whether the proposed rule enlarges, modifies, or contravenes the specific provisions of law implemented, as defined in section 120.52(8)(c); and 4) whether the proposed rule is vague, in violation of section 120.52(8)(d).
Petitioners' Second Amended Petition also asserts that the proposed rule is not supported by the necessary facts. While section 120.52(8)(e), Florida Statutes (2002), defined "invalid exercise of delegated legislative authority" in part as a rule "not supported by competent substantial evidence," that
provision of the definition was deleted in 2003. See § 1, ch. 2003-94, Laws of Fla.; Dep't of Health v. Merritt, 919 So. 2d 561, 564 (Fla. 1st DCA 2006). In that same bill, the Legislature defined the term "arbitrary" for the purposes of section 120.52(8)(e) as "if [the rule] is not supported by logic or the necessary facts." However, Petitioners have stated repeatedly, both in documents and at motion hearings in this case, that they are not challenging the proposed rule as arbitrary and capricious. Given Petitioners' adamant disclaimer of such a claim, no conclusions with respect to the factual basis for the proposed rule will be made in this Final Order.
The decision not to challenge the rule as arbitrary and capricious is significant, because this challenge is not about whether the Board's goal of establishing standards for the administration of conscious sedation is laudable or ludicrous. It may well be that the Board's proposed rule is a step forward in protecting the health, safety and welfare of the public. It may not. The threshold question, however, is not the wisdom of the rule, but whether the Legislature has delegated to the Board the authority to adopt it.
Compliance with Rulemaking Procedures of Sections 120.54 and 120.541
Petitioners assert that the Board did not comply with rulemaking procedures in sections 120.54 and 120.541 in the
following respects: 1) the Board did not prepare a Statement of Estimated Regulatory Costs ("SERC") or consider lower cost regulatory alternatives; 2) the proposed rule is not readable, as required by section 120.54(2)(b); 3) the proposed rule contains more than one subject, in violation of 120.54(1)(g); and 4) the Board did not give appropriate notice as required in section 120.54(2)(a).
1. SERCs and Lower Cost Regulatory Alternatives
With respect to SERCs and lower cost regulatory alternatives, chapter 120 provides the following:
120.54(1)
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(d) In adopting rules, all agencies must, among the alternative approaches to any regulatory objective and to the extent allowed by law, choose the alternative that does not impose regulatory costs on the regulated person, county, or city which could be reduced by the adoption of less costly alternatives that substantially accomplish the statutory objectives.
* * *
ADOPTION PROCEDURES
Notices.--
1. Prior to the adoption, amendment, or repeal of any rule other than an emergency rule, an agency, upon approval of the agency head, shall give notice of its intended action, setting forth a short, plain explanation of the purpose and effect of the proposed action; the full text of the proposed rule or amendment and a summary thereof; a reference to the grant of
rulemaking authority pursuant to which the rule is adopted; and a reference to the section or subsection of the Florida Statutes or the Laws of Florida being implemented or interpreted. The notice must include a summary of the agency's statement of the estimated regulatory costs, if one has been prepared, based on the factors set forth in s. 120.541(2); a statement that any person who wishes to provide the agency with information regarding the statement of estimated regulatory costs, or to provide a proposal for a lower cost regulatory alternative as provided by s. 120.541(1), must do so in writing within 21 days after publication of the notice; and a statement as to whether, based on the statement of the estimated regulatory costs or other information expressly relied upon and described by the agency if no statement of regulatory costs is required, the proposed rule is expected to require legislative ratification pursuant to s. 120.541(3). The notice must state the procedure for requesting a public hearing on the proposed rule. Except when the intended action is repeal of a rule, the notice must include a reference to both the date on which and to the place where the notice of rule development that is required by subsection
appeared.
* * *
Special matters to be considered in rule adoption.--
Statement of estimated regulatory costs.-- Before the adoption, amendment, or repeal of any rule other than an emergency rule, an agency is encouraged to prepare a statement of estimated regulatory costs of the proposed rule, as provided by s.
120.541. However, an agency must prepare a statement of estimated regulatory costs of the proposed rule, as provided by s. 120.541, if:
The proposed rule will have an adverse impact on small business; or
The proposed rule is likely to directly or indirectly increase regulatory costs in excess of $200,000 in the aggregate in this state within 1 year after the implementation of the rule.
Small businesses, small counties, and small cities.--
Each agency, before adoption, amendment, or repeal of a rule, shall consider the impact of the rule on small businesses as defined by s. 288.703 and the impact of the rule on small counties or small cities as defined by s. 120.52. Whenever practicable, an agency shall tier its rules to reduce disproportionate impacts on small businesses, small counties, or small cities to avoid regulating small businesses, small counties, or small cities that do not contribute significantly to the problem the rule is designed to address. An agency may define "small business" to include businesses employing more than 200 persons, may define "small county" to include those with populations of more than 75,000, and may define "small city" to include those with populations of more than 10,000, if it finds that such definition is necessary to adapt a rule to the needs and problems of small businesses, small counties, or small cities. The agency shall consider each of the following methods for reducing the impact of the proposed rule on small businesses, small counties, and small cities, or any combination of these entities:
Establishing less stringent compliance or reporting requirements in the rule.
Establishing less stringent schedules or deadlines in the rule for compliance or reporting requirements.
Consolidating or simplifying the rule's compliance or reporting requirements.
Establishing performance standards or best management practices to replace design or operational standards in the rule.
Exempting small businesses, small counties, or small cities from any or all requirements of the rule.
b.(I) If the agency determines that the proposed action will affect small businesses as defined by the agency as provided in sub- subparagraph a., the agency shall send written notice of the rule to the rules ombudsman in the Executive Office of the Governor at least 28 days before the intended action.
Each agency shall adopt those regulatory alternatives offered by the rules ombudsman in the Executive Office of the Governor and provided to the agency no later than 21 days after the council's receipt of the written notice of the rule which it finds are feasible and consistent with the stated objectives of the proposed rule and which would reduce the impact on small businesses. When regulatory alternatives are offered by the rules ombudsman in the Executive Office of the Governor, the 90-day period for filing the rule in subparagraph (e)2. is extended for a period of 21 days.
If an agency does not adopt all alternatives offered pursuant to this sub- subparagraph, it shall, before rule adoption or amendment and pursuant to subparagraph (d)1., file a detailed written statement with the committee explaining the reasons for failure to adopt such alternatives. Within 3 working days after the filing of such notice, the agency shall send a copy of such notice to the rules ombudsman in the Executive Office of the Governor. (Emphasis supplied.)
120.541 Statement of estimated regulatory costs.--
(1)(a) Within 21 days after publication of the notice required under s. 120.54(3)(a), a substantially affected person may submit to an agency a good faith written proposal for a lower cost regulatory alternative to a proposed rule which substantially accomplishes the objectives of the law being implemented. The proposal may include the alternative of not adopting any rule if the proposal explains how the lower costs and objectives of the law will be achieved by not adopting any rule. If such a proposal is submitted, the 90-day period for filing the rule is extended 21 days. Upon the submission of the lower cost regulatory alternative, the agency shall prepare a statement of estimated regulatory costs as provided in subsection (2), or shall revise its prior statement of estimated regulatory costs, and either adopt the alternative or provide a statement of the reasons for rejecting the alternative in favor of the proposed rule.
If a proposed rule will have an adverse impact on small business or if the proposed rule is likely to directly or indirectly increase regulatory costs in excess of
$200,000 in the aggregate within 1 year after the implementation of the rule, the agency shall prepare a statement of estimated regulatory costs as required by s. 120.54(3)(b).
The agency shall revise a statement of estimated regulatory costs if any change to the rule made under s. 120.54(3)(d) increases the regulatory costs of the rule.
At least 21 days before filing the rule for adoption, an agency that is required to revise a statement of estimated regulatory costs shall provide the statement to the person who submitted the lower cost regulatory alternative and to the committee
and shall provide notice on the agency's website that it is available to the public.
Notwithstanding s. 120.56(1)(c), the failure of the agency to prepare a statement of estimated regulatory costs or to respond to a written lower cost regulatory alternative as provided in this subsection is a material failure to follow the applicable rulemaking procedures or requirements set forth in this chapter.
An agency's failure to prepare a statement of estimated regulatory costs or to respond to a written lower cost regulatory alternative may not be raised in a proceeding challenging the validity of a rule pursuant to s. 120.52(8)(a) unless:
Raised in a petition filed no later than
1 year after the effective date of the rule; and
Raised by a person whose substantial interests are affected by the rule's regulatory costs.
A rule that is challenged pursuant to s. 120.52(8)(f) may not be declared invalid unless:
The issue is raised in an administrative proceeding within 1 year after the effective date of the rule;
The challenge is to the agency's rejection of a lower cost regulatory alternative offered under paragraph (a) or s. 120.54(3)(b)2.b.; and
The substantial interests of the person challenging the rule are materially affected by the rejection.
* * *
If the adverse impact or regulatory costs of the rule exceed any of the criteria established in paragraph (2)(a), the rule shall be submitted to the President of the Senate and Speaker of the House of Representatives no later than 30 days prior to the next regular legislative session, and
the rule may not take effect until it is ratified by the Legislature.
Petitioners' challenge to the Agency's failure to prepare a SERC is based upon the provisions of section 120.52(8)(a), as opposed to a challenge under section 120.52(8)(f). Therefore, no statement of lower cost regulatory alternative had to be offered in order for Petitioners to raise this challenge. Compare § 120.541(1)(f) and (g), Fla. Stat.
A review of the October 7, 2011, Notice of Proposed Rule demonstrates that the Board: a) gave notice of its intended action; b) set forth a short, plain explanation of the purpose and affect of the proposed action; c) provided the full text of the proposed rule and a summary of the rule; d) provided a reference to the grant of rulemaking authority and a reference to the law it purports to implement; e) stated the procedure for requesting a hearing; and f) gave a reference to date and place where the Notice of Rule Development appeared. It is not disputed that the Board did not prepare a SERC. The question to be resolved is whether the Board provided "a statement as to whether, based on the statement of the estimated regulatory costs or other information expressly relied upon and described
by the agency if no statement of regulatory costs is required, the proposed rule is expected to require legislative
ratification pursuant to s. 120.541(3)." § 120.54(3)(a)1., Fla. Stat.
The Board's explanation, as stated in the findings of fact, was as follows:
During discussion of the economic impact of this rule at its Board meeting, the Board, based upon the expertise and experience of its members, determined that a Statement of Estimated Regulatory Cost (SERC) was not necessary and that these rule amendments will not require ratification by the Legislature. No person or interested party submitted additional information regarding the economic impact at that time. The Board has determined that this will not have an adverse impact on small business, or likely increase regulatory costs in excess of $200,000 in the aggregate within
1 year after implementation of the rule.
Section 120.54(3)(a)1., by its plain language, requires the agency to describe "other information expressly relied upon and described by the agency" to determine that legislative ratification is not expected to be required. It is not enough to say that the Board determined that no SERC or ratification was required. The Board must explain why its decision was made and the information relied upon to make that decision. While the Board is certainly invested with expertise and experience, the reference to this expertise is not "other information" as contemplated under the statute. This conclusory statement does not provide information that would shed light on the economic impact of the rule.
The proposed rule clearly contemplates additional training for any registered nurse who may be called upon to administer conscious sedation, including certification in advanced cardiac life support. As stated by Ms. Holloday, the costs related to this additional training have to be borne by someone. While the Board members may have information to which they could apply their knowledge and expertise to explain and support the conclusion that these costs do not meet the threshold for preparing a SERC or for requiring legislative ratification, that information is not included in the Notice of Proposed Rulemaking.
It must be concluded under these circumstances that the Board erred in not preparing a SERC, or providing sufficient information to justify the decision not to do so. The same can be said for the lack of explanation as to why legislative ratification will not be required. Consistent with section 120.541(1)(e), it is found that in noticing the proposed rule, the Board committed a material failure to follow the applicable rulemaking procedures in section 120.54.6/
2. Plain, Simple and Singular
Petitioners also assert that the rule does not comply with section 120.54 because it is too complicated, or is unreadable. Section 120.54(2)(b) requires that all rules should be written in "readable" language, which means the rule avoids
the use of obscure words and unnecessarily long or complicated constructions, and avoids the use of unnecessary technical or specialized language that is only understood by members of particular trades or professions.
It is not the way the proposed rule is constructed, but its content, that Petitioners find truly objectionable. The undersigned has read the proposed rule several times. While it could be simplified, it does not use "obscure" words, and is not so complicated that it cannot be understood.
While it is found that the proposed rule is drafted in readable language, as required by section 120.54(2)(b), the same cannot be said for the requirement in section 120.54(1)(g) that it contain only one subject.
The Notice of Proposed Rule on October 7, 2011, listed the purpose and effect of the rule as being "to establish professional guidelines for the administration of conscious sedation and to update instances of unprofessional conduct." (emphasis added). The rule as it exists without the amendment, including the listing of its authority, law implemented, and amendment history, consists of 22 lines with 15 examples of unprofessional conduct, such as inaccurate recording; misappropriating drugs, supplies or equipment; stealing from a patient; testing positive for any drugs under chapter 893 without a valid prescription; and practicing beyond the scope of
a licensee's license, educational preparation or nursing experience.
The proposed rule keeps those listed examples of unprofessional conduct, but then sets elaborate standards for the administration of conscious sedation, including seven definitions, levels of administration, and criteria for registered nurses to demonstrate competency to administer the sedation. The notices related to the proposed rule sometimes listed unprofessional conduct, sometimes conscious sedation, and sometimes both as the subject matter to be addressed. The inescapable conclusion is that both subjects are addressed in one rule, in violation of section 120.54(1)(g).
3. Appropriate Notice
Finally, with respect to rulemaking requirements in section 120.54, Petitioners assert that the Board failed to comply with notice requirements because the description of the subject matter in the Notice of Rule Development on May 1, 2009, and the one in the Notice of Proposed Rule on October 7, 2011, do not match.
The Notice of Rule Development stated that the Board "proposes the development of rule amendments to address unprofessional conduct with regard to nurses." It identified the rule number and title as rule 64B9-8.005, "Unprofessional Conduct." The Notice of Proposed Rule, published on October 7,
2011, also identified the rule by name and number, but the Purpose and Effect and the Summary both indicated that the proposed rule was "to establish professional guidelines for the administration of conscious sedation and to update the instances of unprofessional conduct." For the public hearing scheduled for December 2, 2011, the subject matter was listed as "conscious sedation," while for the public hearing on
February 3, 2012, the subject matter to be discussed was "unprofessional conduct."
There is no question that the Board was not always consistent with its description of the subject matter of the proposed rule. However, the name and rule number were always identified correctly, and with the exception of the Notice of Rule Development, the text was available. Prior iterations of the rule, with the proposed regulation of the administration of conscious sedation, had been noticed. While the inconsistent description of the subject matter of the rule in the notice may have caused some confusion, none has been demonstrated on the record in this proceeding. Moreover, there is no requirement in section 120.54 that the description of the rule in the development stage and the description contained in the notice of proposed rule actually match. Indeed, in many cases, it is conceivable that the description could and should change as a result of public input in the development of a rule. Material
noncompliance with the requirements of section 120.54 has not been demonstrated with respect to notice.
Whether the Proposed Rule Violates Section 120.52(8)(b)
Petitioners assert that proposed rule 64B9-8.005 is invalid because it "exceeds [the Board's] grant of rulemaking authority, citation to which is required by Section 120.54(3)(a)1., Florida Statutes, by attempting to shoehorn a rule regulating the administration of conscious sedation into a rule defining the term 'unprofessional conduct' since the board lacks statutory authority to regulate the administration of conscious sedation."
The crux of Petitioners' argument with respect to section 120.52(8)(b), is that the grant of rulemaking authority pursuant to section 464.018(1)(h), is not sufficient authority to establish the elaborate standards related to conscious sedation in the proposed rule. Respondent and Intervenors, on the other hand, insist that there is "ample statutory authority" for the rule as noticed.
In order to determine the merits of Petitioners' argument, an examination of the cases interpreting sections 120.52(8) and 120.536 since the 1999 amendments to those sections is necessary. In Southwest Florida Water Management District v. Save the Manatee Club, Inc., 773 So. 2d 594 (Fla. 1st DCA 2000), the First District affirmed the invalidation of
portions of Florida Administrative Code Rule 40D-4.051, because the exemptions from permitting requirements created within the rule had no specific authority. The court determined that the question to be answered is "whether the statute contains a specific grant of authority for the rule, not whether the grant is specific enough. Either the enabling statute authorizes the rule at issue or it does not." Id. at 599. The First District concluded that the challenged rule was invalid because it did not implement or interpret any specific power or duty granted by the enabling statute.
In Board of Trustees of the Internal Improvement Trust Fund v. Day Cruise Association, Inc., 794 So. 2d 696 (Fla. 1st DCA 2001), the Trustees had noticed a proposed rule that would prohibit "cruises to nowhere." The proposed rule cited to section 253.03(7), Florida Statutes, as its rulemaking authority, and sections 253.001, .03, .04 and .77, Florida Statutes (1999), and Article X, section 11, Florida Constitution, as the laws to be implemented. The First District stated:
It is now clear, agencies have rulemaking authority only where the Legislature has enacted a specific statute, and authorized the agency to implement, and then only if the (proposed) rule implements or interprets specific powers or duties, as opposed to improvising in an area that can be said to fall only generally within some class or
powers or duties the Legislature has conferred on the agency.
794 So. 2d at 700; see also Lamar Outdoor Advert. v. Fla. Dep't of Transp., 17 So. 3d 799, 801 (Fla. 1st DCA 2009).
In Department of Children and Family Services v.
I.B., 891 So. 2d 1168 (Fla. 1st DCA 2005), the Department had adopted a rule exempting its decisions with respect to the selection of an adoptive home for a particular child from administrative hearings. The rule was challenged as unauthorized, and the First District agreed with the administrative law judge that no statutes, collectively or individually, provided the necessary specific legislative authority to exempt the selection of adoptive homes from chapter
120. The court also held that after adoption of a rule, an agency may not rely on statutory provisions not cited in the proposed rule as statutory authority for it. Id. at 1172.
The First District also considered the Board of Orthotists' authority to define the term "direct supervision" in Hanger Prosthetics and Orthotics, Inc. v. Department of Health, 948 So. 2d 980 (Fla. 1st DCA 2007). The Board cited section 468.802, Florida Statutes, as its authority, which directed the Board to implement the provisions of the practice act, including by adopting rules relating to standards of practice. The court found that a licensed professional's "direct supervision"
qualified as a standard of practice, and that that the Board acted within its grant of rulemaking authority.
Finally, in Smith v. Department of Corrections, 920 So. 2d 638, 641 (Fla. 1st DCA 2005), the court considered a rule that allowed the Department to charge inmates for copying services and found it to be invalid for lack of specific authority. The court offered the following:
"[A]n administrative rule must certainly fall within the class of powers and duties delegated to the agency, but that alone will not make the rule a valid exercise of legislative power." [Save the Manatee] at
599. "The question is whether the statute contains a specific grant of authority for the rule, not whether the grant of authority is specific enough." Id. (emphasis in original). "Either the enabling statute authorizes the rule or it does not." Id. In addition, under the standard set forth in section 120.52(8), the Department's arguments as to the wisdom of the challenged portions of the rule in light of past experience . . . cannot save the challenged portions of the rule in the absence of specific statutory authority for those provisions.
See also Dep't of Highway Safety and Motor Vehicles v. JM Auto, Inc., 977 So. 2d 733 (Fla. 1st DCA 2008).
With these cases in mind, the question to be answered is whether the grant of authority in section 464.018(1)(h), relied upon by the Board, provides specific authority for proposed rule 64B9-8.005's standards for the administration of conscious sedation. Section 464.018(1)(h) authorizes
disciplinary action for "unprofessional conduct as defined by board rule." The undersigned concludes that statute does not provide the specific authority necessary for this rule consistent with the analysis in Save the Manatee.
This conclusion is further buttressed by section 456.003, Florida Statutes, which provides in pertinent part:
Legislative intent; requirements.—
It is the intent of the Legislature that persons desiring to engage in any lawful profession regulated by the department shall be entitled to do so as a matter of right if otherwise qualified.
* * *
(6) Unless expressly and specifically granted in statute, the duties conferred on the boards do not include the enlargement, modification, or contravention of the lawful scope of practice of the profession regulated by the boards. This subsection shall not prohibit the boards, or the department when there is no board, from taking disciplinary action or issuing a declaratory statement.[7/] (emphasis added).
The Legislature has established the scope of practice for nurses through several sections of chapter 464. In section 464.003, the definitional statute for the Nurse Practice Act, the "practice of practical nursing" is defined as
the performance of selected acts, including the administration of treatments and medications, in the care of the ill, injured, or infirm and the promotion of wellness, maintenance of health, and prevention of illness of others under the
direction of a registered nurse, a licensed physician, a licensed osteopathic physician, a licensed podiatric physician, or a licensed dentist. A practical nurse is responsible for and accountable for making decisions that are based upon the individual's educational preparation and experience in nursing.
§ 464.003(19), Fla. Stat.
Similarly, the "practice of professional nursing" is defined in section 464.003(20) as:
The performance of those acts requiring substantial specialized knowledge, judgment, and nursing skill based upon applied principles of psychological, biological, physical, and social services which shall include, but not be limited to:
The observation, assessment, nursing diagnosis, planning, intervention, and evaluation of care; health teaching and counseling of the ill, injured, or infirm; and the promotion of wellness, maintenance of health, and prevention of illness of others.
The administration of medications and treatments as prescribed or authorized by a duly licensed practitioner authorized by the laws of this state to prescribe such medications and treatments.
The supervision and teaching of other personnel in the theory and performance of any of the acts described in this subsection.
A professional nurse is responsible and accountable for making decisions that are based upon the individual's educational preparation and experience in nursing.
Chapters 458 and 459, Florida Statutes, dedicated to the licensing and regulation of allopathic and osteopathic physicians, respectively, recognize the scope of practice for
registered and licensed practical nurses. For example, section 458.303(2) provides:
Nothing in s. 458.301, s. 458.303, s. 458.305, 458.307, s. 458.309, s. 458.311, s.
458.313, s. 458.319, s. 458.321, s. 458.327,
s. 458.329, s. 458.331, s. 458.337, s.
458.339, s. 458.341, s. 458.343, s. 458.345,
or s.458.347 shall be construed to prohibit any service rendered by a registered nurse or a licensed practical nurse, if such service is rendered under the direct supervision and control of a licensed physician who provides specific direction for any service to be performed and gives final approval to all services performed.
. . .
A similar provision is contained in section 459.002(2), Florida Statutes.
The Legislature has also provided for an expanded role for nurses in certain situations, and has been very specific with respect to the authority to adopt rules concerning the scope of those expanded roles. In section 464.003(2), the Legislature defined "advanced or specialized nursing practice" and provided the following:
(2) "Advanced or specialized nursing practice" means, in addition to the practice of professional nursing, the performance of advanced-level nursing acts approved by the board which, by virtue of postbasic specialized education, training, and experience, are appropriately performed by an advanced registered nurse practitioner. Within the context of advanced or specialized nursing practice, the advanced registered nurse practitioner may perform acts of nursing diagnosis and nursing
treatment of alterations of the health status. The advanced registered nurse practitioner may also perform acts of medical diagnosis and treatment, prescription, and operation which are identified and approved by a joint committee composed of three members appointed by the Board of Nursing, two of whom must be advanced registered nurse practitioners; three members appointed by the Board of Medicine, two of whom must have had work experience with advanced registered nurse practitioners; and the State Surgeon General or the State Surgeon General's designee. . .
. The Board of Nursing shall adopt rules authorizing the performance of any such acts approved by the joint committee. Unless otherwise specified by the joint committee, such acts must be performed under the general supervision of a practitioner licensed under chapter 458, chapter 459, or chapter 466 within the framework of standing protocols which identify the medical acts to be performed and the conditions for their performance. The department may, by rule, require that a copy of the protocol be filed with the department along with the notice required by s. 458.438. (emphasis added).
Section 464.018(1)(h) allows rulemaking for one purpose: to define unprofessional conduct. Prior to the attempts to establish standards for conscious sedation, rule 64B9-8.005 did just that, identifying conduct such as stealing from patients, diverting drugs, testing positive for controlled substances, and similar wrongful acts.
The launching point for the establishment of standards for administering conscious sedation is the inclusion of "practicing beyond the scope of the licensee's license,
educational preparation, or nursing experience" as a form of "unprofessional conduct." While included in the proposed rule, this conduct is addressed separately as one of the statutory grounds for disciplinary action. See § 464.018(1)(n), (authorizing discipline for "failing to meet minimal standards of acceptable and prevailing nursing practice, including engaging in acts for which the licensee is not qualified by training or experience.").
Given that performing acts for which a licensee is not qualified by training or experience is already prohibited by statute, while Petitioners do not challenge it, it is questionable whether this prohibition should even be included in the proposed rule. Section 120.74 requires agencies to review their rules every two years and delete those that are redundant of statutes. § 120.74(1)(d), Fla. Stat. This provision in the proposed rule is unnecessarily duplicative of section 464.018(1)(n), which confirms that the provision is misplaced in a rule implementing section 464.018(1)(h). Even assuming its inclusion in the rule defining unprofessional conduct is permissible, it does not expand the Board's authority to define unprofessional conduct to also permit the Board to promulgate standards for the administration of conscious sedation.
The Board is granted rulemaking authority in a number of areas: in section 464.008 (to establish guidelines for
remedial courses for those who fail the nursing examination three times); section 464.0115 (to administer certification of clinical nurse specialists); section 464.012 (to administer the certification of advanced registered nurse practitioners, including the appropriate requirements for advanced registered nurse practitioners in the categories of certified registered nurse anesthetists, certified nurse midwives, and nurse practitioners); section 464.013 (to establish a procedure for the biennial renewal of licenses and to prescribe continuing education requirements for renewal of licenses); section 464.014 (to provide application procedures for inactive status, for the biennial renewal of inactive licenses, and for the reactivation of licenses, including applicable fees); and section 464.018(5) (to establish disciplinary guidelines). However, the Legislature did not grant express rulemaking authority to the Board to promulgate nursing standards of practice. Save the
Manatee, supra.
By contrast, in chapters 458 and 459, the Boards of Medicine and of Osteopathic Medicine were given specific rulemaking authority to define standards of practice. For example, section 458.331(1)(v) makes it a violation for "[p]racticing or offering to practice beyond the scope permitted by law or accepting and performing professional responsibilities which the licensee knows or has reason to know that he or she is
not competent to perform." With respect to that violation, the Legislature has provided very specific rulemaking authority:
The board may establish by rule standards of practice and standards of care for particular practice settings, including, but not limited to, education and training, equipment and supplies, medications including anesthetics, assistance of and delegation to other personnel, transfer agreements, sterilization, records, performance of complex or multiple procedures, informed consent, and policy and procedure manuals.
The same authority is given to the Board of Osteopathic Medicine in section 459.015(1)(z), Florida Statutes.
While these provisions are in different practice acts, chapters 458, 459 and 464 all govern health-care professionals regulated within the Department. The prohibitions in each chapter with respect to practicing beyond what the licensee is capable of performing are quite similar. Yet the authority to define scope of practice is noticeably absent in section 464.018.
The doctrine of in pari materia "is a principle of statutory construction that requires that statutes relating to the same subject or object be construed together to harmonize the statutes and to give effect to the Legislature's intent." Lamar Outdoor Advert. v. Dep't of Transp., 17 So. 3d 799, 803- 804 (Fla. 1st DCA 2009)(quoting Fla. Dep't of State v. Martin, 916 So. 2d 763, 768 (Fla. 2005)); Ortiz v. Dep't of Health, Bd.
of Med., 882 So. 2d 402, 404 (Fla. 1st DCA 2004). Given the Legislature's express and specific grants of authority to establish standards of practice to other Boards, and the absence of this same grant to the Board of Nursing, it must be concluded that the rulemaking authority to establish standards of practice with regard to conscious sedation has not been granted to the Board. This is especially apparent in this instance where the Legislature has expressly stated in section 464.019 that the Board has no rulemaking authority with respect to nursing education programs, and the Legislature has expressly prohibited the Board from modifying practice standards, in section 456.003(6).
Moreover, the rulemaking grant in section 464.018(1)(h), to define unprofessional conduct, does not give the Board the authority to define other terms. Yet in the proposed rule, the Board seeks to define the terms "deep sedation," "general anesthesia," "moderate sedation," "immediately available," "palliative sedation," "refractory symptoms," and "duly authorized practitioner." The fact that the Board felt the need to define other terms in order to establish standards for administration of conscious sedation, only solidifies the conclusion that the true intent of the proposed rule is to establish those standards, and not to define unprofessional conduct. Section 464.018(1)(h) simply does not
give the Board that authority, and the proposed rule exceeds the grant of rulemaking to define unprofessional conduct, as defined in section 120.52(8)(b).
Whether the Proposed Rule Violates Section 120.52(8)(c)
The proposed rule also violates section 120.52(8)(c), because it both enlarges the scope of section 464.018(1)(h) and contravenes other restraints on rulemaking. As previously stated, section 456.003(6) expressly limits the ability of the Board to modify or contravene the lawful scope of practice of the practice of a profession regulated by the boards. "Where the section cited as the ground for rulemaking is specifically limited by another statute, interpretation of the specific powers and duties conferred upon the agency is required. Where rulemaking is granted in one statute, it should not be read in such a way as to negate restrictions on rulemaking authority set out in a different section." Ortiz, 882 So. 2d at 405. Given the restriction in section 456.003(6) on the Board's authority, the grant in section 464.018(1)(h) must be strictly construed. "Otherwise, specific legislative directives could be eliminated through the Board's exercise of its rulemaking authority." Id.
Whether the Proposed Rule is Vague
Finally, Petitioners challenge the proposed rule's definition of "duly authorized practitioner," as vague. The definition contained in the proposed rule is as follows:
Duly authorized practitioner means a physician licensed under Chapter 458 or Chapter 459, a dentist licensed under Chapter 466 who is authorized to order and administer anesthesia or sedation, a podiatrist who is authorized under Chapter 461, a certified registered nurse anethestist authorized under Chapter 464, and by protocol to order and administer anesthesia or sedation, or a certified nurse midwife authorized under Chapter 464 and by protocol to order or administer anesthetics.
A rule is considered vague in violation of section 120.52(8)(d) if it requires performance of an act in terms that are so vague that men of common intelligence must guess as to its meaning. S.W. Fla. Water Mgmt. Dist. v. Charlotte Cnty., 774 So. 2d 903, 915 (Fla. 2d DCA 2001).
Petitioners' contention is two-fold: 1) that the rule refers to a "podiatrist" as opposed to a "podiatric physician," which is the statutory phrase for identifying a podiatric physician; and 2) that by identifying a "podiatrist who is authorized under Chapter 461" immediately after identifying "a dentist licensed under Chapter 466 who is authorized to order and administer anesthesia or sedation," the proposed rule leaves the impression that there are podiatric physicians who are not authorized to administer anesthesia or sedation.
Prior to 1998, podiatric physicians were statutorily identified as podiatrists. The name was changed to podiatric
physicians during the 1998 legislative session. §§ 200-209, Ch. 98-166, Laws of Fla. While the correct statutory term is certainly preferable, use of the less-favored term does not render the proposed rule so vague as to make a reasonable person confused as to its meaning.
However, identifying a duly authorized practitioner in part as a "podiatrist who is authorized under Chapter 461" immediately after identifying "a dentist licensed under Chapter
466 who is authorized to order and administer anesthesia or sedation," presents a different issue. Not all dentists are authorized to administer anesthesia. § 466.017, Fla. Stat. The listing of podiatric physicians in the manner identified in the proposed rule may lead to the conclusion that not all podiatric physicians are authorized to order or administer conscious sedation, and may cause a licensee to be unsure whether the particular podiatric physician is an authorized practitioner within the definition of the rule. To that limited extent, the proposed rule is vague.
Petitioners have requested attorneys' fees and costs pursuant to section 120.595(2). Inasmuch as this Final Order determines that the proposed rule is an invalid exercise of delegated legislative authority as defined in section 120.52(8)(a),(b), (c), and (d), Petitioners are entitled to a
hearing as to entitlement and, if entitled, the amount of any
reasonable fees and costs.
ORDER
Based on the foregoing Findings of Fact and Conclusions of Law, it is ORDERED that proposed rule 64B9-8.005 is an invalid exercise of legislatively delegated authority. Jurisdiction is retained for the purpose of determining reasonable attorney's fees and costs. Any motion to determine fees and costs shall be filed within 60 days of the issuance of this Final Order.
DONE AND ORDERED this 2nd day of November, 2012, in Tallahassee, Leon County, Florida.
LISA SHEARER NELSON
Administrative Law Judge
Division of Administrative Hearings The DeSoto Building
1230 Apalachee Parkway
Tallahassee, Florida 32399-3060
(850) 488-9675
Fax Filing (850) 921-6847 www.doah.state.fl.us
Filed with the Clerk of the Division of Administrative Hearings this 2nd day of November, 2012.
ENDNOTES
1/ Official recognition of the FDA Ruling, however, does not make the statements contained therein automatically admissible. As stated by Professor Ehrhardt:
Taking judicial notice of a fact does not dispense with the evidence meeting the
requirements of the other exclusionary rules. . . . Generally, judicial notice may not be used as a method of avoiding the application of the hearsay rule which excludes other out-of-court statements that are offered to prove the truth of the matter asserted. For example, factual findings in evaluative reports of public agencies are not admissible under the public record exception, section 90.803(8). The
policy of the hearsay rule should not be circumvented by counsel persuading the court that it is appropriate to take judicial notice of the truth of facts asserted in hearsay documents. Although the cases are not clear, the better reasoned cases hold that while it may be appropriate to take judicial notice that a document exists it is not appropriate to take judicial notice of the truth of the facts asserted in the document.
C. Ehrhardt, Florida Evidence § 201.1 (2011 Edition)(quoting Wright & Graham, Federal Practice and Procedure: Evidence § 6337 ("For example, it is commonly said that a court may take judicial notice of its own records, . . .. But as appellate courts frequently state, this does not mean that the court can take judicial notice of every hearsay statement that appears in court records . . .. The distinction between noticing the contents of a record and noticing the truth of the contents resembles the distinction in the hearsay doctrine between offering an out-of-court statement simply to show it was said, and offering it for the truth of the matter asserted.")).
2/ Petitioners' Motion for Official Recognition recites facts 57-99, which they represent are admitted in Respondent's responses to Petitioners' Second Request for Admissions served on Petitioners, by electronic mail on Friday, August 17, 2012. However, those responses to Requests for Admissions are not on file with the Division, and notwithstanding Petitioners' assertion that the responses with which they were served were not filed with the Division, they did not file them in support of their motion. Respondent and the Intervenors, in their Joint Response to the Motion for Official Recognition and Motion for Summary Final Order, did not specifically object to any proposed finding of fact in the Motion as being in dispute, and did not take issue with the Petitioners' statement that the findings
were taken from Respondent's Response to Petitioners' Second Request for Admissions. In any event, to the extent that any of those proposed findings are reflected in the Findings of Fact in this Final Order, they were taken from the JAPC correspondence, of which the undersigned takes official recognition.
3/ To be clear, however, any perceived flaws in prior iterations of the rule are not at issue in this proceeding. It is the current language of the proposed rule as noticed in the Notice of Change that is subject to challenge.
4/ Reference to the comments of JAPC staff are not meant to convey an endorsement or rejection of the positions taken by JAPC or its staff, but simply to indicate that the Board was on notice of the specific concerns stated. See note 1, supra.
5/ This subsection has since been renumbered as subsection 464.019(9).
6/ Petitioners also assert in their Motion for Summary Final Order that the Board has failed to comply with the rulemaking requirements of section 120.54(1)(a) because the proposed rule does not address the lack of anesthesia providers in small counties and cities, and other anesthesia-provider shortage areas, and does not address small physician businesses and small ambulatory surgical centers that may not be able to afford the more expensive providers or training required by this proposed rule. Other failures with regard to the requirements to consider the costs to small businesses are catalogued by Petitioners. While it does not appear that the Board considered these things, no finding can be made to that effect because the rulemaking record is not in the record in this proceeding.
Given that void, it cannot be determined whether the Board considered those factors and did not believe the impact to be significant, or simply did not consider them at all.
7/ References to the Department are to the Department of Health. The boards referred to are boards or other statutorily created entities authorized to exercise regulatory or rulemaking functions within the Division of Medical Quality Assurance.
§ 456.001(1), (3), Fla. Stat.
COPIES FURNISHED:
Wendy Smith Hansen, Esquire
Wendy Smith Hansen, Attorney at Law 9670 Deer Valley Drive Tallahassee, Florida 32312
Holly Randall Miller, Esquire Florida Medical Association
113 East College Avenue Tallahassee, Florida 32301
Jason David Winn, Esquire Jason D. Winn, P.A.
Suite 2-C
119 East Park Avenue Tallahassee, Florida 32301 jwinn@jwinnlaw.com
Jeffery M. Scott, Esquire Florida Medical Association
113 East College Avenue Tallahassee, Florida 32301
Lee Ann Gustafson, Esquire Department of Legal Affairs The Capitol, Plaza Level 01 Tallahassee, Florida 32399
leeann.gustafson@myfloridalegal.com
James W. Linn, Esquire
Lewis, Longman and Walker, P.A.
315 South Calhoun Street Tallahassee, Florida 32301
Cynthia A. Mikos, Esquire Allen Dell, P.A.
Suite 100
202 South Rome Avenue Tampa, Florida 33606
Anna Gay Small, Esquire Allen and Dell
Suite 100
202 South Rome Avenue Tampa, Florida 33606
Paul H. Amundsen, Esquire Lewis, Longman and Walker, P.A. Suite 830
315 South Calhoun Street Tallahassee, Florida 32301
Liz Cloud, Program Administrator Administrative Code
Department of State
R. A. Gray Building, Suite 101 Tallahassee, Florida 32399 (eServed)
Ken Plante, Coordinator
Joint Administrative Procedures Committee Room 680, Pepper Building
111 West Madison Street Tallahassee, Florida 32399-1400 (eServed)
Joe Baker, Jr., Executive Director Board of Nursing
Department of Health
4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1703 (eServed)
NOTICE OF RIGHT TO JUDICIAL REVIEW
A party who is adversely affected by this Final Order is entitled to judicial review pursuant to section 120.68, Florida Statutes. Review proceedings are governed by the Florida Rules of Appellate Procedure. Such proceedings are commenced by filing the original notice of administrative appeal with the agency clerk of the Division of Administrative Hearings within
30 days of rendition of the order to be reviewed, and a copy of the notice, accompanied by any filing fees prescribed by law, with the clerk of the District Court of Appeal in the appellate district where the agency maintains its headquarters or where a party resides or as otherwise provided by law.
| Issue Date | Document | Summary |
|---|---|---|
| Feb. 28, 2014 | Mandate | |
| Feb. 12, 2014 | Opinion | |
| Nov. 02, 2012 | DOAH Final Order | Proposed rule 64B9-8.005 is an invalid exercise of degelated legislative authority as defined in section 120.52(8)(a)(b)(c) and (d). |
