The purpose of this amendment is to establish professional guidelines for the administration of conscious sedation and to update the instances of unprofessional conduct.

 

DEPARTMENT OF HEALTH
Board of Nursing

RULE NO.: RULE TITLE:
64B9-8.005: Unprofessional Conduct

PURPOSE AND EFFECT: The purpose of this amendment is to establish professional guidelines for the administration of conscious sedation and to update the instances of unprofessional conduct.

SUMMARY: The purpose of this amendment is to establish guidelines for the administration of conscious sedation and to update the instances of unprofessional conduct in the nursing occupation.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COST:

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.

RULEMAKING AUTHORITY: 464.006, 464.018(1)(h) FS.
LAW IMPLEMENTED: 464.018(1)(h) FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FLORIDA ADMINISTRATIVE WEEKLY.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Joe R. Baker, Jr., Executive Director, Board of Nursing, 4052 Bald Cypress Way, Bin #C02, Tallahassee, Florida 32399

 

THE FULL TEXT OF THE PROPOSED RULE IS:

64B9-8.005 Unprofessional Conduct.

(1) 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) 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.

(b) 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.

(c) 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.

(d) In order to administer or monitor any pharmacologic agents in accordance with subsection (a) or (b) above, a registered nurse must:

1. 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;

2. 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;

3. 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.

4. 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;

5. Ensure that written policies and procedures for managing patients who receive moderate sedation are reviewed periodically and are readily available within the practice setting;

6. Ensure that the practice setting has in place a quality assurance and performance improvement process that measures patient, process and structural outcome indicators; and

7. 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.

(e) 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.

(f) The following definitions apply for purposes of this rule:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

Rulemaking Authority 464.006, 464.018(1)(h) FS. Law Implemented 464.018(1)(h) FS. History–New 11-28-79, Amended 3-16-81, 10-8-81,9-11-83, Formerly 210-10.05, Amended 4-21-86, 2-5-87, 8-2-90, 3-12-91, 9-16-91, 4-8-92, 9-29-92, Formerly 210-10.005, Amended 9-7-93, Formerly 61F7-8.005, Amended 11-6-94, 5-1-95, 11-16-95, Formerly 59S-8.005, Amended 2-18-98, 3-23-00, 2-17-02, 7-5-06, 12-11-06, 4-28-09,________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Nursing

NAME OF SUPERVISOR OR PERSON WHO APPROVED THE PROPOSED RULE: Board of Nursing

DATES PROPOSED RULE APPROVED BY AGENCY HEAD: February 4 and April 8, 2011

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: May 1, 2009