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MARYLAND BOARD OF NURSING DECLARATORY RULING TUESDAY

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MARYLAND BOARD OF NURSING DECLARATORY RULING TUESDAY Powered By Docstoc
					  REPLACES        DR 96-1
                  DR-93-3
                  DR-02-2
                               MARYLAND BOARD OF NURSING

                                 DECLARATORY RULING 2003-3

                                               TUESDAY
                                            OCTOBER 28, 2003

  RE: REGISTERED NURSE ADMINISTRATION OF PROCEDURAL SEDATION FOR
  OPERATIVE, INVASIVE AND DIAGNOSTIC PROCEDURES AND FOR EPISODIC
 TREATMENTS OR THERAPIES FOR THE ADULT AND PEDIATRIC PATIENT,
 (E.G. INTRAVENOUS, INTRAMUSCULAR, INHALATION, ORAL, RECTAL, AND
 INTRANASAL)

The Board of Nursing received a petition from Johns Hopkins Hospital, Baltimore, Maryland and

additional telephone calls from the community requesting the Board=s recommendation to permit

the Certified Registered Nurse Practitioner (CRNP) and the Certified Registered Nurse

Midwife (CRNM) to prescribe procedural sedation when the CRNP or CRNM is performing

a client procedure or diagnostic test which is part of the CRNP or CRNM=s collaborative

agreement. The questions to be answered by this document included but were not limited to:

1. May a registered nurse administer conscious sedation at the direction of a physician assistant,

certified registered nurse practitioner (CRNP), or certified registered nurse midwife (CRNM)

licensed dentist, or licensed podiatrist?

  2.    May a registered nurse administer conscious sedation to a patient whose pre-anesthesia

        assessment is classified as ASA III or ASA IV?



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3.      May a registered nurse administer procedural sedation for a operative, invasive and

        diagnostic procedure exceeding two hours in length extending to possibly eight hours

        in length?

4.      Is the administration of chloral hydrate by oral route to the pediatric patient considered

        conscious sedation?

5.      Are there patient conditions or circumstances which require the patient to be assessed by a

        licensed qualified anesthesia provider (e.g., licensed physician who has substantial

        specialized knowledge, judgment and skill related to anesthesia or a certified registered

        nurse anesthetist)?

6.      May a registered nurse monitor a patient receiving procedural sedation induced by a

        medication the registered nurse is not permitted to administer and when the medication is

        administered by the licensed physician or CRNP or CRNM performing the procedure?

7.      May a registered nurse administer Ketamine, an anesthetic agent, intramuscularly to a

        patient, for purposes of procedural sedation?

8.      May a registered nurse administer Propofol or Ketamine, both anesthetic agents,

        intravenously to patient requiring analgesia for pain treatments such as burn dressing

        changes?

9.      May the registered nurse obtain the patient=s informed consent for procedural sedation?




The Board is authorized to issue declaratory rulings pursuant to State Government Article



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10-301 et seq. and the Maryland Board of Nursing Regulations Governing Issuance of Petitions

for   a Declaratory Ruling COMAR 10.27.08.

         For the purpose of clarity, the following terms have been defined to mean:

 1. AProcedural sedation@ also known as conscious sedation or moderate sedation or sedation

 analgesia is produced by the administration of a single pharmaceutical agent, or a combination of

 pharmacological agents, by one of several common routes: intravenous, intramuscular,

 inhalation, oral, rectal and intranasal. A patient under procedural sedation has a depressed level

 of consciousness but retains the ability to: maintain protective reflexes, independently and

 continuously maintain a patent airway, and respond appropriately to physical stimulation and/or

 verbal command. Procedural sedation may be easily converted into a state of deep sedation

 and/or loss of consciousness because of the unique characteristics of the medication or

 combination of medications used, as well as other factors indicating the physical status and

 medication sensitivities of the individual patient. The administration of procedural sedation

 requires continuous monitoring of the patient and the ability to respond immediately to any

 deviation from normal.

 2. ADeep Sedation@ is a drug induced depression of consciousness during which the patient

 cannot be easily aroused and may not respond purposefully following repeated or painful

 stimulation. The ability to independently maintain ventilatory function may be impaired.

 Patients may require assistance to maintain a patent airway and spontaneous ventilation may be

 inadequate. Cardiovascular functioning is usually maintained.

 3. ARescuing@ means the competency to manage a compromised airway, provide adequate

 oxygenations and ventilation, and prescribe or administer reversal agents per the licensee=s scope



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  of practice until the patient recovers the ability to maintain a patent airway and ventilate to

  adequate oxygenation or is transferred to a higher level of care.

 4. AASA Pre-Anesthesia Assessment@ the American Society of Anesthesiologists define each of

 the ASA classifications to be:

          $ Class I       A normal healthy patient other than surgical pathology-without systemic

                         disease.

          $ Class II     A patient with mild systemic disease - no functional limitations.

          $ Class III    A patient with moderate to severe symptoms disturbance due to medical or

                         surgical disease - some functional limitation but not incapacitating.

          $ Class IV     A patient with severe systemic disturbance which poses a constant threat to

                         life and is incapacitating.

          $ Class V      A moribund patient not expected to survive 24 hours with or without

                         surgery.

          $ Class E      If the case is an emergency, the physical status is followed by the AE@-

                         e.g.?IIE@.

 5. ANitrous oxide 50% or less@ means the administration of a fixed concentration of 50% nitrous

 oxide and 50% oxygen.

6. ANitrous oxide 50% or less for procedural sedation@ means the administration of nitrous oxide

50% or less without any other sedative narcotics or other depressant drug before or concurrent with

the nitrous oxide 50% or less to an otherwise healthy ASA Class I or II patient.

7. APediatric Patient@ means a patient who is a full term infant of at least six weeks to twelve years

of age.



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8. AEpisodic Treatments or Therapies@ means prescribed actions such as dressing changes or

debridement etc. that may occur once or on an ongoing basis that may cause the patient to become

agitated or increase the patient=s discomfort or alter the patient=s hemodynamic status.

9. AImmediately available@ means physically present, on site, in the unit of care and not otherwise

engaged in any other uninterruptable procedure or task.

GENERAL DISCUSSION:

       The administration of procedural sedation by specially trained registered nurses other than

the Certified Registered Nurse Anesthetist (CRNA) requires thorough and comprehensive

assessment and evaluation of six critical elements which comprise the environment under which

.procedural sedation is administered. These six critical elements to be considered by the specially

trained registered nurse are:

1.     The specialized education and training required for the registered nurse to administer,

monitor, and rescue the patient. The nurse=s considerations would include but not be limited to

patient assessment and potential interaction with or reaction to: the procedure to be performed; the

patient=s morbidity/co-morbidity factors; and the medication or combination of medications utilized

to induce and reverse procedural sedation.

 2.      The licensed physician or CRNP or CRNM prescribing the procedural sedation for the

 procedure he or she is performing has been credentialed by the facility to prescribe procedural

 sedation. Factors to be considered in the credentialling process include but may not be limited to:

 the medication or combination of medications utilized to induce and maintain the patient in a state

 of procedural sedation including dosage ranges, effects, side effects, contraindications, and

 reversal agents; standardized nationally recognized patient anesthesia assessment guides; airway



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classification and management; Dysrhythmia recognition; and knowledge and skills required to

rescue a patient.

3.         Clinical status of the patient receiving procedural sedation including but not limited to:

procedure to be performed; current prescribed and over-the-counter medications, including

herbals; current clinical status including ability to cooperate; and morbidity/co-morbidity. A

significant factor for consideration concerns the administration of procedural sedation in an

emergency, when there has not been an opportunity to assess and prepare the patient for the

procedure.

4.         The requirements of the clinical setting in which the procedural sedation is to be




administered include but are not limited to: sufficient knowledge, skill, and availability of

personnel to respond to an emergency; and sufficient technology and emergency equipment

available (including the resources necessary to rescue a patient receiving procedural sedation). It

is noted that in the free standing ambulatory clinical setting, which may be comprised of one

primary physician who performs the procedure and also prescribes the procedural sedation and

one registered nurse administering and monitoring the patient during procedural sedation, these

identified elements are of a greater significance. When the clinical setting has limited resources

and those personnel resources have limited knowledge, skill and abilities, then there is a greater

risk for the patient. The registered nurse as a patient advocate has the obligation to evaluate these

factors prior to agreeing to assume responsibility for administering procedural sedation in this

setting.



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 7.     Monitoring the patient receiving procedural sedation includes but is not limited to: the

 activities which the registered nurse must perform to monitor the patient while simultaneously

 administering the procedural sedation and the technical equipment required to perform the

 monitoring and rescue activities.

 8.     The prescribing physician or CRNP or CRNM and the registered nurse administering the

 procedural sedation have a dependent and inter-dependent relationship. Examples of this

 dependent/inter-dependent relationship include but are not limited to:

                1) the prescribing physician or CRNP or CRNM is depending upon the specially

                trained registered nurse to possess the requisite knowledge, judgement and skill to

                administer procedural sedation, safely monitor the patient, and practice in

                compliance with the practice setting or facility=s written policies and procedures.

                2) The registered nurse is depending on the prescribing physician or CRNP or

                CRNM to be knowledgeable about how to appropriately assess the patient=s status

                in anticipation of procedural sedation, the medication(s) the physician is

                prescribing to induce procedural sedation and the practice setting or facility=s

                written policies and procedures.

                3) The inter-dependence of the relationship is reflected throughout the process of

                performing the procedure, administering sedation, monitoring and Arescuing@ a

                patient. An example of the inter-dependence may be Arescuing@ which may



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                include but is not limited to each individual=s knowledge, skill and judgment to

                manage the patient=s airway, select or administer reversal agents and other

                emergency medications etc.

 BOARD RULING:

        Given the above definitions and description of the critical elements , the Board has

 determined that it is within the scope of practice of a specially trained registered nurse to

 administer and monitor procedural sedation for a defined patient population (e.g. pediatric or

 adult) undergoing an operative, invasive and/or diagnostic procedure and for episodic treatments

 or therapies given specific conditions/circumstances. For a specially trained registered nurse to

 administer procedural sedation, all of the following specific conditions must be met:

 1.     Medication(s) must be ordered only by the licensed physician or CRNP or CRNM who is

 performing the procedure or caring for the patient during the diagnostic test, and who is:

                A. credentialed by the facility to prescribe procedural sedation; and

                B. immediately available.

 Immediately available as used in this document means physically present on site, in the unit of

 care and not otherwise engaged in any other uninterruptible procedure or task.

 2.     The registered nurse has the right and the responsibility to REFUSE to administer any




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                medication(s) that may induce procedural sedation when in the professional

                judgement of the registered nurse, the medication or combination of medications,

                the dosages prescribed, or frequency of administration may produce a state of deep

                sedation or place the patient at risk for complication.

                3.     The practice setting or facility must have in place an educational and

                credentialing mechanism which includes a process for evaluating and documenting

                the registered nurse's demonstration of the knowledge, skills, and abilities related

                to the management of patients receiving procedural sedation. Evaluation and

                documentation of ongoing competency should occur on an annual basis.

                4. In order for the RN to be able to administer procedural sedation the practice

                setting or facility must have policies and procedures detailing:

                A) dosing parameters for each drug or combinations of drugs which the registered

                nurse may administer for procedural sedation;

                B) reversal agents and dosages of each for the agents utilized to reverse the effects

                of procedural sedation and evaluation criteria to determine the continuation or

                discontinuation of the procedural sedation.

                C) a pre-anesthesia patient classification system.

                D) an airway classification system.

                E) fasting protocol



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                F) a patient discharge criteria.




                G) provisions for backup personnel who possess proficiency in airway

                management including endotracheal intubation and pharmacological interventions

                including Advanced Cardiac Life Support (ACLS) Pediatric Advanced Life

                Support (PALS) or substantially equivalent training.

                H) the critical elements that must be documented when these dosing parameters

                have been exceeded.

                I) The registered nurse=s right to refuse to administer and monitor procedural

                sedation (congruent with this declaratory ruling) and the action the registered nurse

                is to take when the right to refuse is exercised.

 5. To be qualified to administer procedural sedation and to monitor the patient receiving

 procedural sedation, the registered nurse must possess knowledge, skill and educational

 preparation which would include but is not limited to:

        A. Basic anatomy and physiology specific to the defined patient population.

        B. Pharmacology of the medications given during procedural sedation including:

                1. Dosage parameters appropriate to the age and weight of the patient and over

                what period of time these drugs should be administered;



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F\shared\practice\scope\declrlgs\2003-3proceduralsed.dr
                2. Mechanism of action of commonly prescribed procedural sedation

                medication(s);

                3. Contraindications(s) to the administration of each procedural sedation

                medication and the appropriate interventions;




                4. The effects of procedural sedation medication(s) on the patient=s pre-existing

                conditions.

                5. Side effects and complications associated with each procedural sedation

                medication and the appropriate reversal agents(s).

                6. Mechanism of action and use of appropriate reversal agents.

        C. Considerations relative to common therapeutic, diagnostic or surgical procedures and

        the administration of procedural sedation, (an example is the prone positioning for

        Endoscopic Retrograde Cholangio Pancreatography (ERCP).

        D. Familiarity/or orientation to the practice setting in which the registered nurse would be

        administering the procedural sedation.

        E. Principles of oxygen delivery.

        F. Knowledge regarding resuscitation, airway management, and life threatening

        dysrhythmia recognition.



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F\shared\practice\scope\declrlgs\2003-3proceduralsed.dr
        G. Completion of Basic Life Support (BLS) for the Health Care Provider or substantially

        equivalent education.

        H. Completion of a supervised clinical practicum to obtain competency prior to

        performing procedural sedation.

        I. Knowledge of medical and legal implications, responsibilities and ramifications of

        administration of procedural sedation.




 6.     The registered nurse administering the procedural sedation must have the primary

 responsibilities for monitoring the patient during the procedure and may not leave the patient

 unattended or engage in uninterruptible tasks that would compromise continuous monitoring.

 7.     All patients receiving INTRAVENOUS procedural sedation must have a patent

 intravenous access maintained from the beginning of medication administration until recovery

 from procedural sedation.

 8.     Supplemental oxygen and appropriate delivery equipment must be available to all patients

 receiving procedural sedation.

 9.     All patients receiving procedural sedation must be CONTINUOUSLY MONITORED

 THROUGHOUT THE PROCEDURE with respect to by the following elements and according to

 currently recognized national nursing professional specialty standards:



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F\shared\practice\scope\declrlgs\2003-3proceduralsed.dr
        A. Continuous pulse oximetry.

        B. Continuous cardiac monitoring for patients with hypertension, cardiovascular disease

        or known dysrhythmia.

        C. Intermittent blood pressure monitoring, heart rate, and respiratory rate.

        D. Behavioral indicators for level of pain i.e. crying, moaning, etc.

        E. Airway patency to assure ventilatory adequacy.

        F. Level of consciousness or response to stimuli.

 10.     Recommended patient elements to be monitored include but are not limited to:

        A. Continuous cardiac monitoring in all patients;

        B. Monitoring of body temperature;




                                                             C. Monitoring of intake and output;

                                                             and,

        D. Monitoring of the skin which include the color, temperature, turgor, etc.

 11.    All patients receiving procedural sedation must be MONITORED THROUGHOUT THE

 RECOVERY PHASE:

        A. according to currently recognized national nursing professional specialty standards;

        B. by continuous pulse oximetry; and



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F\shared\practice\scope\declrlgs\2003-3proceduralsed.dr
        C. by intermittent monitoring of blood pressure, heart rate and respiratory rate.

 12.    In order for the registered nurse to administer procedural sedation, the setting must have

 the capabilities for rescuing the patient. The emergency equipment (sized to the patient

 population) that is required to be immediately accessible to every patient receiving procedural

 sedation includes but is not limited to:

        A. Ambu bag, and source for 100% O2,

        B. Suction equipment and machine;

        C. Airway and intubation equipment;

        D. Defibrillator or an automatic external defibrillator and cardiac monitor;

        E. Emergency medications and reversal medications;

        F. Cricothyroidotomy kit, (i.e. 14 gauge needle, scalpel, kelly clamp, and cricothryroid

        tube).

 13.    In order for the registered nurse to administer procedural sedation there must be access




 to designated higher level care providers who possess proficiency in airway management,

 including endotracheal intubation and pharmacological interventions and ACLS/PALS or

 substantially equivalent education. Access is to be defined by the facility=s policies and

 procedures which is discussed in item four (4).



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F\shared\practice\scope\declrlgs\2003-3proceduralsed.dr
 14.    When the registered nurse is administering procedural sedation, the registered nurse is

 expected to consider the potential risk factors, that singly or in combination could increase the risk

 of complications associated with procedural sedation. These include but are not limited to:

                A.      The frail patient and the patient with extremes of age.

                B.      Inability to communicate or cooperate as in compromised mental status or

                language barrier.

        C.      Significantly developmentally delayed.

        D.      Severe morbidity or co-morbidity (e.g. cardiac, pulmonary, hepatic, hematological,

                renal, central nervous system, musculoskeletal, endocrine and, or multiple

                medications).

        E.      Morbid obesity.

        F.      History of sleep apnea.

        G.      History of drug, alcohol, tobacco use or abuse.

        H.      Pregnancy.

        I.      Emergency procedure with lack of patient preparation.

        J.      Airway anomalies.

        K.      Previous adverse experience with sedation, analgesia or anesthesia.

        L.      Unstable vital signs (low blood pressure, tachycardia, or bradycardia).

        M.      Pulse oximetry of 94 or below on room air.



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F\shared\practice\scope\declrlgs\2003-3proceduralsed.dr
N.    Implantable devices (i.e. epidural pumps, pacemakers, etc).

O.    Use of narcotics within 24 hours of procedure.

P.    Recent colds, flu or fever.

      These risks may be reduced by consultation with the appropriate specialist or anesthesia provider

     or both. The patient=s morbidity or co-morbidity may also indicate the need for pre-procedure

     testing or diagnostic studies or both, which can reduce the risk of complications. When, in the

     professional judgment of the registered nurse, the patient=s risk factors are such that the registered

     nurse believes there is substantial jeopardy to the patient, the registered nurse has the right and the

     obligation to REFUSE to administer the procedural sedation.

     15.     The practice setting or facility requires that the Performance Improvement or

      Risk Management Review Process includes a review of the prescribing, administration and

      monitoring of patients receiving procedural sedation including but not limited to:

             A) Frequency of patient complications;

             B) Type of patient complication;

             C) Appropriate identification and management of the patient=s complication; and,




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     F\shared\practice\scope\declrlgs\2003-3proceduralsed.dr
        D) Review and modification of the practice setting or facility policies, procedures,

        protocols and the training program as dictated by the Performance Improvement or Risk

        Management Review outcomes.

16.     FOR THE PEDIATRIC PATIENT receiving procedural sedation the following applies:

        A. All previously stated conditions relative to the registered nurses knowledge, skill and

        educational preparation apply.




        B. All previously stated conditions relative to the practice setting or facility=s policies,

        procedures and education and credentialing mechanism apply.

        C. All previously stated conditions relative to the monitoring of the patient during the

        procedure, apply to the pediatric patient EXCEPT the monitoring of the blood pressure

        which may be omitted during the procedure if the performance of the blood pressure

        reading would interfere with the procedure (an example may be a Magnetic Resonance

        Imaging).

        D. All previously stated conditions relative to post procedure monitoring apply.

        E. Special considerations regarding the pediatric patient includes knowledge of the

        metabolism and elimination of the specific medication by age and weight. The registered

        nurse administering procedural sedation to the pediatric patient must have specialized



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F\shared\practice\scope\declrlgs\2003-3proceduralsed.dr
        knowledge of the medications utilized to induce procedural sedation and Rescue of the

        pediatric patient. Medication which are frequently recognized and utilized to induce

        procedural sedation by oral or rectal route may include oral fentanyl lollipop, morphine,

        chloral hydrate, phentobarbitol, valium, ativan, versed and demerol.

        F. The registered nurse MAY administer procedural sedation to a pediatric patient who is

        ASA I and ASA II. The registered nurse may not administer procedural sedation to a

        pediatric patient whose pre-anesthesia assessment is classified as an ASA III or IV except

        in clinical practice settings that are in acute care institutions AND when the consultation

        and recommendations of the certified registered nurse anesthetist or physician with

        specialized knowledge, judgment, and skill related to anesthesia are followed.




        G. The registered nurse MAY administer nitrous oxide 50% or less to the pediatric patient

        in compliance with the American Academy of Pediatrics Guidelines for Monitoring and

        Management for Pediatric Patients During and After Sedation for Diagnostic &

        Therapeutic Procedures and according to the facility=s waste gas evacuation policies. At a

        minimum, the following conditions with regard to the administration of nitrous oxide 50%

        or less shall exist:




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F\shared\practice\scope\declrlgs\2003-3proceduralsed.dr
              1. The pediatric patient is able to maintain verbal communication throughout

               the procedure

               2. The registered nurse administering nitrous oxide 50% or less must have

               the primary responsibility for monitoring the patient during the procedure and may

               not leave the patient unattended or engage in uninterruptible tasks that would

               compromise continuous monitoring.

              3. Pulse oximetry is strongly recommended but not required.

        H. The registered nurse MAY administer Ketamine for procedural sedation in critical care

        practice settings that are in acute care institutions and when the consultation and

        recommendations of the certified registered nurse anesthetist or licensed physician who

        has been credentialed by the facility as a qualified anesthesia provider are followed.

        I. The registered nurse may NOT administer a combination of demerol, phenergan and

        thorazine (i.e. DPT cocktail) intramuscularly to a pediatric patient for the purpose of

        sedation, procedural sedation or analgesia.




 17.    The registered nurse MAY administer procedural sedation as prescribed by a Board

        Certified Registered Nurse Practitioner (CRNP) or Certified Registered Nurse Midwife

        (CRNM) when the CRNP or CRNM:



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F\shared\practice\scope\declrlgs\2003-3proceduralsed.dr
                A) has an approved collaborative agreement which designates prescription of

                procedural sedation is a part of the individual=s practice.

                B) is providing care and prescribing procedural sedation to the client population

                addressed in the individual=s collaborative agreement.

                C) has received additional training to act as the resource for the registered nurse

                who is administering the procedural sedation, including Arescuing@ the client.

18.     The following situations are NOT considered procedural sedation and are NOT considered

        under this declaratory ruling.

         A) patients who are sedated for the purpose of immediate intubation such as a patient

         receiving Ketamine or Etomidate for emergent intubation.

         B) patients who receive sedation for tolerance of mechanical

                 ventilation, such as an intensive care patient receiving a propofol infusion to

                 tolerate the ventilator.

         C) patients who are receiving sedation solely for the purpose of managing altered

         mental status, such as patients receiving haldol or ativan.

         D) patients receiving continuous or intermittent analgesia for pain control without

         sedatives, i.e., topical, intravenous or implanted ports/pumps.

19.     The registered nurse may NOT administer procedural sedation utilizing medications

        classified as an anesthetic agent to include but not limited to propofol, diprivan,


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F\shared\practice\scope\declrlgs\2003-3proceduralsed.dr
        ketamine or inhalation anesthetics ( see exceptions in item 16 addressing the pediatric

        patient).

 20.    The registered nursed may NOT administer procedureal sedation to a patient who se pre-

        anesthesia assessment is classified as an ASA IV except:

                A) in clinical practice settings that are in acute care institutions; and

                B) when the consultation and recommendations of the certified registered nurse

                anesthetist or licensed physician who has been credentialed by the facility as a

                qualified anesthesia provider are followed.

  21.    The registered nurse may NOT administer procedural sedation prescribed by a physician

         assistant, licensed podiatrist or licensed dentist (for further information regarding the

         dentist prescribing please contact the Maryland Board of Dentistry).

  22.    The registered nurse may NOT administer procedural sedation to the patient (including

  pediatric and adult) whose pre-anesthesia assessment is classified as a ASA V.

  23.    Prior to the procedure beginning, the nurse has the right and responsibility to REFUSE to

         administer the medication for procedural sedation when:

                    A) the medication is one the nurse is prohibited from administering;

                    B) in the registered nurse's professional judgment the patient's clinical status is

         compromised and proceeding would place the patient a unnecessary risk.

                    C) the initial prescribed dose of the medication is outside the recommended



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F\shared\practice\scope\declrlgs\2003-3proceduralsed.dr
                 dosage parameters and may place the patient at risk of deep sedation.

24.     When the registered nurse REFUSES to administer procedural sedation given the

        circumstances enumerated in item 22, and when the physician performing the procedure

        assumes responsibility for administering of the medications, the registered nurse has the

        right and the responsibility to REFUSE to monitor the patient and should attempt to

        transfer the patient=s care to a certified registered nurse anesthetist or licensed physician

        who has been credentialed by the facility as a qualified Anesthesia provider while

        continuing to monitor the patient until relieved.

25.     During the course of the procedure, the registered nurse has the right and the responsibility

        to REFUSE to administer subsequent doses of procedural sedation in amounts that may

        convert the patient=s state to deep sedation or cause decompensation of the patient=s vital

        signs. In this instance, the registered nurse should attempt to transfer the patient=s care to a

        certified registered nurse anesthetist or licensed physician who has been credentialed by the

        facility as a qualified anesthesia provider while continuing to monitor the patient until

        relieved or until the procedure is completed.

 26. The registered nurse must REPORT when he or she has refused to administer or monitor the

      patient and document all circumstances of the refusal in accordance with the Performance

      Improvement or Risk Management Review Process.

 27. Given that all conditions and requirements of this declaratory ruling are met, there is no limit



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       on the length of time the registered nurse may administer procedural sedation.




 28.   The registered nurse may NOT obtain informed consent for the administration of procedural

       sedation.

 EPISODIC TREATMENTS OR THERAPIES

 29.   The registered nurses may NOT administer Propofol, an anesthetic agent, except as described

       in the Declaratory Ruling addressing the Registered Nurse Administration of Medications

       Classified as Anesthetic Agents.

 30.   In acute care settings a registered nurse MAY administer Ketamine, an anesthetic agent, by

       intravenous solution to pediatric patients requiring treatment for bronchospasms when all

       conditions and requirements enumerated in the Declaratory Ruling Addressing Administration

       of Medication Classified as Anesthetic Agents are met.

 31.   A registered nurse may NOT administer Ketamine, an anesthetic agent intramuscularly or

       intravenously to an adult patient for purposes of procedural sedation.

CONCLUDING STATEMENT:

       When procedural sedation is administered by a qualified, specially trained registered nurse




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F\shared\practice\scope\declrlgs\2003-3proceduralsed.dr
  it can NOT be assumed that this registered nurse possesses the same degree of knowledge, skill,

   and judgment as that of a certified registered nurse anesthetist or licensed physician or CRNP or

CRNM who has been credentialed by the facility as a qualified anesthesia provider. Therefore, the

critical factors which create the opportunity for the specially trained registered nurse to administer

procedural sedation must be thoroughly and comprehensively assessed and evaluated by the

registered nurse prior to taking action OR no action on the licensed physician or CRNP or CRNM=s

prescriptive order. These critical factors include but are not limited to: the knowledge and skill of

the registered nurse and the prescribing physician regarding medication(s) to induce and reverse the

procedural        sedation; the knowledge and skills of the registered nurse and the prescribing

physician to evaluate and monitor the patient during procedural sedation; the knowledge and skill of

the registered nurse and the prescribing physician or CRNP or CRNM to Arescue@ the patient; the

available technology and personnel available within the facility to monitor and rescue the patient; and

the patient=s clinical status, including morbidity, co-morbidity and potential effects of the procedural

sedation medication(s) in relation to these factors and the procedure to be performed.

       The registered nurse is responsible and accountable for all actions or lack of action that he or s

   he takes when administering an anesthetic or monitoring the patient receiving procedural sedation

   or both. In addition, the registered nurse is always held to the fundamental principle of nursing

   which is, do no harm.

       The registered nurse is required to have the same knowledge base for the medication(s)



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F\shared\practice\scope\declrlgs\2003-3proceduralsed.dr
 administered to induce procedural sedation as for any other medication that he or she administers.

 This knowledge base includes but is not limited to:

      1)      Effects, side effects, and contraindications of each drug to be administered.

      2)      The amount of the medication to be administered at any one time (including initial

              dose, subsequent doses and total amount of the medication(s) administered for the

              procedure).

      3)      Ability to anticipate and recognize potential complications of each drug and

      combination of drugs.

      4)      Ability to recognize emergency situations and institute appropriate nursing

      interventions.




     Should all of the Board=s stipulated conditions contained in this Board ruling NOT be

 met, then the registered nurse has the right and responsibility to REFUSE to administer medication

 and/or monitor the patient receiving procedural sedation or both prior to the initiation of the

 procedure.

     Because this specialized procedure requires specialized education, training and nursing judgment,

 the registered nurse is held accountable to REFUSE to perform this specialized act or any other act

  of nursing which is beyond the parameters of the licensee's education, capabilities and experience.



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                                           REFERENCES

 Written:

     1.      Association of Operating Room Nurses. Standards, Recommended Practices, and

     Guidelines: Managing the Patient Receiving Conscious Sedation/Analgesia. 1998,

     pp 165-170.

     2.      American Academy of Pediatrics. Guidelines for Monitoring and Management of

     Pediatric Patients During and After Sedation for Diagnostic and Therapeutic Procedures. January

     2001.

     3.      American Society of Peri-Anesthesia Nurses Standards. Advanced Life Support (ACLS)

     Pediatric Life Support/PALS and ACLS/PALS Equivalent Programs.

     4.      Nechyba, Christian, MD and Gunn, Veronica L. MD, Editors. The Harriet Lane

     Handbook: A Manual For Pediatric House Officers. 16th Edition. C.V. Mosby. St. Louis 2002.

     5.      American Society for Gastroentestinal Endoscopy:




             A) Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologist. February

             1996.

             B) Technology Assessment Status Evaluation - Monitoring Equipment for Endoscopy.



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            November 1994.

            C) Guidelines for Training in Patient Monitoring and Sedation and Analgesia. October

            2000.

            D) Sedation and Monitoring of Patients Undergoing Gastrointestinal Endoscopic

            Procedures. October 2000.

     6.     American Association of Nurse Anesthetist:

            A) The Certified-Registered Nurse Anesthetist in Alternative Practice Settings. Policy

            No. 2.1. May 1988.

            B) Qualified Providers of Conscious Sedation. Policy No. 2.2. June 1996.

            C) The Separation of Operator/Anesthetist Responsibilities. Policy No 2.3.

            May 1998.

            D) Suggested Guidelines for Registered Professional Nurses Engaged in The

            Administration of IV Conscious Sedation. Addendum to Policy No. 2 .2.

            April 1991.

            E) Administration of Nitrous Oxide by Qualified Anesthesia Providers. Policy No. 2.4.

            June 1989.

            F) Scope and Standards For Nurse Anesthesia Practice. October 1999.

            G) Standards For Office Based Anesthesia Practice. October 1999.




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            H) Code of Ethics. October 1999.

            I) Preparedness For Treatment of Malignant Hyperthermia. October, 1999.

            J) Latex Allergy Protocol. October 1999

     7.     American Society of Anesthesiologist:

            A) Basic Standards for Pre-Anesthesia Care. October 1987.

            B) Standards For Basic Anesthesia Monitoring: October 1986 and Amended/Revised

            October 1998.

     C) Standards For Post Anesthesia Care. October 1988 and Amended/Revised October 1994.

     D) Guidelines for Ambulatory Anesthesia and Surgery. October 1973 and Amended/Revised

     October 1998.

     E) Guidelines for Non-Operating Room Anesthesiology Locations. October 1994.

     F) Practice Guidelines For Sedation and Analgesia by Non-Anesthesiologists: Report of Task

     Force. October 1999. pp. 1-8.

     8.     Vanderbilt Medical Center, Anesthesiology Educational Guide:

            A) The Patient Evaluation Process. October 1999.

            B) Laboratory Tests and Their Preoperative Indications. October 1999.

     C) Guidelines for Perioperiative ElectroCardiology. October 1999.

            D) Guidelines for Preoperative Chest Radiography. October 1999.



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F\shared\practice\scope\declrlgs\2003-3proceduralsed.dr
            E) Guidelines On Pulmonary Function Tests. October 1999.

     9.     Joint Commission on Accreditation of Hospitals and Organizations:

            A) Standards of Conscious Sedation. January 1999.




            B) Standards and Intents for Sedation and Anesthesia Care. January 2001.

     10.    How to Comply with TX. 8, the New Resuscitation Standard. Briefings on JCAHO.

            Vol. 11, No 8. August, 2000.

     11.    ________, The Practice of Anesthesiology. Chapter One.

     12.    ______, Nurses Uneasy about IV Sedation for Long Cases. OR Manager. March, 2000.

     13.    Health Occupations Article, Title 8, The Nurse Practice Act.

     14.    Declaratory Ruling 96-1, Re: Registered Nurse Administration of Conscious Sedation For

     Short Term Therapeutic, Diagnostic, and Surgical Procedures.

     15.    Advisory Opinion-Conscious Sedation. Arizona State Board of Nursing, October, 1997.

     16.    Position Statement-Registered Nurse Management of Patients Receiving IV Conscious

     Sedation for Short Term Therapeutic, Diagnostic or Surgical Procedures. Arkansas Board of

     Nursing, November, 1994.

     17.    Position Statement-Registered Nurse Administration of Medication for the Purpose of

     Induction of Conscious Sedation for Short Term Therapeutic, Diagnostic or Surgical



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     Procedures. California Registered Nurse Board of Nursing, 1995.

     18.    Guidelines-Registered Nurse Administration, Management and Monitoring of the Patient

     Receiving IV Conscious Sedation During Therapeutic, Diagnostic or Surgical Procedures.

     Connecticut Board of Nursing

     19.    Guidelines-Registered Nurse Administration, Management and Monitoring of the Patient

     Receiving Conscious Sedation During Therapeutic, Diagnostic or Surgical Procedures.

     Delaware Board of Nursing.




     20.    Advisory Opinion-Role of the Registered Nurse in the Management of Patients Receiving

     IV Conscious Sedation for Short Term, Therapeutic, Diagnostic or Surgical Procedures.

     Kentucky Board of Nursing

     21.    Declaratory Ruling regarding Registered Nurse Administration Management and

     Monitoring of the Patient Receiving IV Conscious Sedation. Louisiana Registered Nurse Board

     of Nursing.

     22.    Position Statement-Role of the Registered Nurse in the Administration of IV Conscious

     Sedation During Short Term, Therapeutic, Diagnostic or Surgical Procedures. Massachusetts

     Board of Nursing, November 1999.

     23.    Position Statement-Role of the Registered Nurse in the Administration, Monitoring of IV



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     Conscious Sedation. Mississippi Board of Nursing. April, 2000.

      24.    Position Statement-Registered Nurse Administration, Management and Monitoring of

     Patients Receiving IV Conscious Sedation. Missouri Board of Nursing.

     25.    Advisory Opinion-Analgesia/Conscious Sedation. Nebraska Board of Nursing.

     26.    Advisory Opinion-Conscious Sedation. New Mexico Board of Nursing.

     27.    Guidelines-Administration, Management and Monitoring of IV Conscious Sedation by

     Non-Anesthetists RNs. New York Board of Nursing.

     28.    Position Statement-The Role of the Registered Nurse in the Management of Patients

     Receiving IV Conscious Sedation. North Carolina Board of Nursing, June, 2000.




     29.    Position Statement-The Role of the Registered Nurse in the Management of Patients

     Receiving Conscious Sedation/Analgesia. For Therapeutic, Diagnostic or Surgical Procedures.

     North Dakota Board of Nursing, May 2000.

     30.    Guidelines-Administration, Management and Monitoring of IV Conscious Sedation.

     Oklahoma Board of Nursing.

     31.    Position Statement-Registered Nurse Administration of Conscious Sedation During

     Therapeutic, Diagnostic or Surgical Procedures. Oregon Board of Nursing, November, 1997.

     32.    Position Statement-Role and Scope of Responsibilities of the RN to administer



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          medications fore Pre-Operative Sedation and Conscious Sedation as Ordered by a Licensed

          Physician or Dentist. South Carolina Board of Nursing.

          33.    Position Statement-The Role of the Registered Nurse in the Management of Clients

          Receiving IV Conscious Sedation for the Short Term, Therapeutic, Diagnostic or Surgical

          Procedure. South Dakota Board of Nursing.

          34.    Position Statement-Administration of IV Conscious Sedation by the Registered Nurse.

          Texas Board of Registered Nurse Examiners.

          35.    Policy Statement-Registered Nurses Performing Procedural Sedation. The Nursing Care

          Quality Assurance Commission, State of Washington.

Personnel:

1.        Laura Kress, RN, MAS, Nurse Manager, Inpatient and Outpatient Endoscopy Units, Johns

          Hopkins Hospital, Baltimore, Maryland.

2.        JoAnn Walker, RN, BS, CNOR, St. Agnes Health Care, Department of Education and

          Development, Baltimore, Maryland.




3.        Mary Ann Smith, RN, CGRN, Clinical Coordinator, Shore Health System, Digestive Health

          Center, Easton, Maryland.

4.        Mary Ann Sipple, RN, Nurse Manager, PACU & Endoscopy Units, Western Maryland Health



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          Systems, Memorial Hospital and Medical Center, Cumberland, Maryland.

5.        Marijo Cosmas, RN, MS, CRNP, Vascular and General Surgical Services, Calvert Memorial

          Hospital, Prince Frederick, Maryland.

6.        John Hitchens, CRNA, Jarrettsville, Maryland,

7.        Robin Mattheiss, CRNA, Lutherville, Maryland.

8.        Noel McElwee, CRNA, Baltimore, Maryland..

9.        Lisa LaCivita, BSN, CRNA, Annapolis, Maryland.

10.       Mary A. Rogers, BSN, RN, Nurse Manager, CGRN, Endoscopy, North Arundel Hospital, Glen

          Burnie, Maryland.

11.      Ann Sessoms, RN, MSN, CCRN, Clinical Specialist/Critical Care, Peninsula Regional Medical

         Center, Salisbury, Maryland.

12.      Barbara Christensen, RN, Nurse Manager-Cardiac Cath Lab, Washington Adventist Hospital,

         Takoma Park, Maryland.

13.      Kathleen Shiring, RN, CRN, Clinical Nurse III-Educator for Interventional Radiology, Anne

         Arundel Medical Center, Annapolis, Maryland.

14.      Karen Carlson, RN, CRN, Nurse Manager Radiology, Suburban Hospital, Bethesda, Maryland.

15.      Kathy Reisig, RNC, Pediatric Patient Care Coordinator, St. Joseph Medical Center, Towson,

         Maryland.

16.      Betty Nethkin, RN, Director of Nursing MCH, St. Joseph Medical Center, Towson, Maryland.



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      17.       Elizabeth Lins RN, Assistant Unit Manager, Surgical Intensive Care Unit, Johns Hopkins Hospital,

                Baltimore, Maryland.

      18.       Deborah Cowell RN, MSN, Clinical Nurse Specialist, Critical Care, North Arundel Hospital, Glen

                Burnie, Maryland.

      19.       Deborah Timms, RN, Clinical Nurse Coordinator, Emergency Department, Shore Health System,

                Easton, Maryland.

      20.       Margaret Garrett, RN, Esq. Senior Counsel, Johns Hopkins Hospital, Baltimore, Maryland.

      21.       Deborah Dang RN, MS, Director of Nursing Practice, Education and Research, Johns Hopkins

                Hospital, Baltimore, Maryland.

      22.       Julie Stanik-Hutt, CRNP, Assistant Professor of Nursing, Johns Hopkins University, School

                of Nursing, CRNP Program, Baltimore, Maryland.

      23.       Carol Ann Huff, M.D. , Assistant Professor, Medicine - Oncology, John Hopkins University and

                 Director of Hemotologic Malignancy Program, Johns Hopkins Hospital, Baltimore, Maryland.

24.    Sandra Dearholt, RN, MS, Coordinator of Nursing Practice, Johns Hopkins Hospital, Baltimore,

                 Maryland.




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