DEPARTMENT OF HEALTH
Board of NursingRULE NO: RULE TITLE
64B9-17.001: Statement of Intent of Purpose
64B9-17.002: Definitions
64B9-17.003: Competency and Knowledge RequirementsSECOND NOTICE 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.31,No.11, March 18, 2005 issue of the Florida Administrative Weekly.
The changes reflect several additional amendments to the proposed rule that have been made since a Notice of Change was published in Vol. 31, No. 34 of the November 4, 2005 issue of the Florida Administrative Weekly. These additional changes were made to address concerns expressed by the Joint Administrative Procedure Committee and by parties affected by the proposed rules. The additional changes were approved by the Board at its February 8, 2006 meeting. After the changes are made to the affected parts of the rule, those parts of the rule will read as follows:
Subsection (2) of rule 64B9-17.001 will now read as follows:
(2) The purpose of this rule is to protect the public by ensuring that competent registered nurses administer conscious sedation and deep sedation. The rule sets out the education and/or competency verification necessary to administer medications for conscious sedation and deep sedation under specific conditions. Pursuant to Section 464.018(1)(h), F.S., 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 and would also be a violation of Section 464.018(1)(j) and (n), F.S. Further, this role is beyond the scope of practice for the licensed practical nurse or the tasks allowed for unlicenced assistive personnel. The administration of medications via any route for the purpose of general anesthesia or medications that the manufacturer package insert indicates should be administered only by persons trained in the administration of anesthesia is not within the scope of registered nursing or licensed practical nursing practice.
Subsections (2), (4) and (5) of rule 64B9-17.002 will now read as follows:
(2) For purposes of this rule, institution means a hospital or ambulatory surgery center licensed under provisions of Chapter 395 F.S., a physician office setting, clinic, or any other setting in which conscious sedation is utilized. A hospice is a program which is licensed under Part VI of Chapter 400, F.S. and which may provide palliative care using conscious sedation. It would be a violation of this rule for any registered nurse to administer medications for conscious sedation in any other setting that is not appropriately licensed or registered, to the extent required by state law, to enable surgical procedures to take place in that setting.
(4) The manufacturer package insert is a document required and approved by the Food and Drug Administration in accordance with 21 CFR 201-1-201-317. The purpose of the insert is to advise the practitioner of the conditions under which the drug should be prescribed; the disorders it is recommended to relieve; the precautionary measures which should be observed, and warnings of adverse effects that may result.
(5) Medications used to achieve conscious sedation include benzodiazepines, opioids, dissociative agents, sedatives, and hypnotics and should be given, in accordance with the manufacturer package insert, in small, incremental doses that are titrated to the desired endpoints of analgesia and sedation. Sufficient time must elapse between doses to allow the effect of each dose to be assessed before subsequent drug administration. The administration of these medications alone or in combination may produce profound synergistic effects.
Subsections (1)(c), (d), (i) and (j) of rule 64B9-17.003 will now read as follows:
(c) The registered nurse must have successfully completed a program in conscious sedation developed by the institution or by an approved continuing education provider. The content of that program must, at a minimum, be four hours in length, contain information on the definitions, knowledge, education and competency requirements in this rule, including the continuum of levels of sedation, and on drugs used during conscious sedation, including reversal agents, their actions, side-effects and untoward effects, manufacturer package insert, and assessment and monitoring of the patient receiving the medication. The program must also address recognition of emergency situations, institution of appropriate nursing interventions, and evaluation of physiologic measurements, such as respiratory rate, oxygen saturation, blood pressure, cardiac rate and rhythm, and the patient's level of consciousness.
(d) The registered nurse administers medications to achieve conscious sedation by executing the order of a qualified anesthesia provider or physician licensed under Chapter 458 or 459, F.S. Although the determination of medical dosage and the patient’s medical status is a medical decision, the registered nurse has the right and the obligation to question orders and decisions which are contrary to acceptable standards of nursing practice, to refuse to participate in procedures which may result in harm to the patient, and to refuse to administer or continue to administer medications in amounts that may induce general anesthesia or that may lead to respiratory or cardiovascular compromise.
(i) The institution must have written protocols in place to include, but not be limited to: patient monitoring and devices to be utilized, drug administration, location and availability of manufacturer package inserts for medication to be used in conscious sedation, directions for dealing with potential complications or emergency situations, and availability of a physician. These protocols must be reviewed at frequent intervals to assure that they are within current and accepted standards of practice. The frequency of review should be consistent with review of other policies in the institution or practice setting.
(j) The institution must have a mechanism for determining and documenting education/training, clinical competency, and a process for documenting the individual's demonstration of knowledge, skills, and ability related to management of patients during conscious sedation. Both evaluation and documentation of competence shall be done on an annual basis and within current and expected standards of nursing practice and within parameters established in manufacturer package inserts for medications used for conscious sedation.
A newly added Subsection (2) will read as follows:
(2) In a hospice program, a registered nurse may administer medications to achieve conscious sedation for palliative care provided the registered nurse has completed the knowledge, education and competency requirements in this rule and may manage patients who are receiving conscious sedation.
(a) The registered nurse administers medications only in dosages titrated to achieve conscious sedation for palliative care.
(b) The registered nurse must have successfully completed a program in conscious sedation developed by the institution or by an approved continuing education provider. The content of that program must, at a minimum, be four hours in length, contain information on the definitions, knowledge, education and competency requirements in this rule, including the continuum of levels of sedation, and on drugs used during conscious sedation, including reversal agents, their actions, side-effects and untoward effects, manufacturer package insert, and assessment and monitoring of the patient receiving the medication. The program shall be appropriate to palliative care and must also address recognition of emergency situations, institution of appropriate nursing interventions, and evaluation of physiologic measurements, such as respiratory rate, oxygen saturation, blood pressure, cardiac rate and rhythm, and the patient's level of consciousness.
(c) The registered nurse administers medications to achieve conscious sedation by executing the order of a qualified anesthesia provider or physician licensed under Chapter 458 or 459, F.S. Although the determination of medical dosage and the patient’s medical status is a medical decision, the registered nurse has the right and the obligation to question orders and decisions which are contrary to acceptable standards of nursing practice, to refuse to participate in procedures which may result in harm to the patient, and to refuse to administer or continue to administer medications in amounts that may induce general anesthesia or that may lead to respiratory or cardiovascular compromise.
(d) The institution must have written protocols in place to include, but not be limited to: drug administration, location and availability of manufacturer package inserts for medication to be used in conscious sedation, and availability of a physician. These protocols must be reviewed at frequent intervals to assure that they are within current and accepted standards of practice. The frequency of review should be consistent with review of other policies in the institution or practice setting.
(e) The institution must have a mechanism for determining and documenting education/training, clinical competency, and a process for documenting the individual's demonstration of knowledge, skills, and ability related to management of patients during conscious sedation. Both evaluation and documentation of competence shall be done on an annual basis and within current and expected standards of nursing practice and within parameters established in manufacturer package inserts for medications used for conscious sedation.
Subsections (2), (3) and (4) shall be renumbered as Subsections (3), (4) and (5).
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Joe Baker, Jr., Acting Executive Director, Board of Nursing, 4052 Bald Cypress Way, Bin C07, Tallahassee, Florida 32399-3259.
