The proposed rule is to establish professional guidelines for the administration of conscious sedation and to update the instances of unprofessional conduct.  


  • RULE NO: RULE TITLE
    64B9-8.005: Unprofessional Conduct
    PURPOSE AND EFFECT: The proposed rule is to establish professional guidelines for the administration of conscious sedation and to update the instances of unprofessional conduct.
    SUMMARY: The proposed rule 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 COSTS: No Statement of Estimated Regulatory Cost was prepared.
    Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
    SPECIFIC 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 FAW.
    THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Rick Garcia, Executive Director, Board of Nursing/MQA, 4052 Bald Cypress Way, Bin #C02, Tallahassee, Florida 32399-3252

    THE FULL TEXT OF THE PROPOSED RULE IS:

    (Substantial rewording of Rule 64B9-8.005, F.A.C. See Florida Administrative Code for present text.)

    64B9-8.005 Disciplinary Proceedings Unprofessional Conduct.

    Unprofessional conduct shall include: 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:

    (1) A registered nurse may, pursuant to physician order, administer or monitor the administration of medications to achieve deep sedation to a patient who is continuously monitored and mechanically ventilated with a secured, artificial airway, or to a patient for end of life care, including hospice patients. Examples of medications used for deep sedation in this situation include, but are not limited to, propofol, pentothal and dexmedetomidine. 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 experienced in general anesthesia and not by a registered nurse, with the exception of a patient who is continuously monitored and mechanically ventilated with a secured, artificial airway.

    (2) 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) 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.

    (3) A registered nurse or licensed practical nurse may administer prescribed pharmacologic agents to patients for the relief of existing pain and anxiety, but not for the purpose of deep sedation for a surgical, diagnostic or therapeutic procedure.

    (4) In order to administer or monitor any pharmacologic agents in accordance with subsection (1) or (2) above, a registered nurse must:

    (a) Prior to any administration or monitoring of any pharmacologic agents, successfully complete a program of study which reflects the extent of privileges requested and which will include a criteria-based competency evaluation. At a minimum, course content will include: 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;

    (b) 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;

    (c) Ensure that the practice setting requires that the prescribing physician is immediately available throughout the procedure and recovery period;

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

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

    (f) 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.

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

    (a) 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.

    (b) 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.

    (c) 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.

    (d) 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.

    (6) Pharmacologic agents that may be administered by a registered nurse or licensed practical nurse pursuant to subsections (2) and (3) 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.

    Rulemaking Specific 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 21O-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 21O-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 AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Nursing
    DATE PROPOSED RULE APPROVED BY AGENCY HEAD: June 3, 2009
    DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: May 1, 2009

Document Information

Comments Open:
3/19/2010
Summary:
The proposed rule is to establish guidelines for the administration of conscious sedation and to update the instances of unprofessional conduct in the nursing occupation.
Purpose:
The proposed rule is to establish professional guidelines for the administration of conscious sedation and to update the instances of unprofessional conduct.
Rulemaking Authority:
464.006, 464.018(1)(h) FS.
Law:
464.018(1)(h) FS.
Contact:
Rick Garcia, Executive Director, Board of Nursing/MQA, 4052 Bald Cypress Way, Bin #C02, Tallahassee, Florida 32399-3252
Related Rules: (1)
64B9-8.005. Disciplinary Proceedings