DEPARTMENT OF HEALTH
Board of NursingRULE NO.: RULE TITLE:
64B9-8.005: Unprofessional ConductNOTICE OF CHANGE
Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 37, No. 40, October 7, 2011 issue of the Florida Administrative Weekly.
The changes are due to concerns by the Joint Administrative Committee in their letter dated October 17, 2011. The changes are as follows:
When 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) 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.
(b) 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 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.
(c) 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.
(d) In order to administer or monitor any pharmacologic agents to achieve deep sedation in accordance with paragraph (a) 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. 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;
2. 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;
3. 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;
4. Ensure that the practice setting has in place a quality assurance and performance improvement process that measures patient, process and structural outcome indicators; and
5. 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) In order to administer or monitor any pharmacologic agents to achieve moderate sedation in accordance with subsection (b) above, a registered nurse must:
1. 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;
2. Ensure that written policies and procedures for managing patients who receive moderate sedation are reviewed periodically and are readily available within the practice setting;
3 Ensure that the practice setting has in place a quality assurance and performance improvement process that measures patient, process and structural outcome indicators; and
4. 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) 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.
(g) 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 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.
7. 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.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Joe Baker, Jr., Executive Director, Board of Nursing, 4052 Bald Cypress Way, Bin #C02, Tallahassee, Florida 32399-3252
