APPLICABILITY

These rules are applicable to patients receiving conscious sedation as follows: Patients from 18 to 60 years old who receive intravenously > 5mg of Versed or > 20 mg. of Valium or any dosage of narcotics

Patients 60 years of age and older who receive intravenously >3.5 mg of Versed or > 10 mg if Valium or any dosage of narcotic

All pediatric patients

Patients receiving any combination of drugs

At the discretion of the physician and/or staff, this policy can be initiated for patients receiving dosages of drugs less than those listed above.

EXCLUSIONS

This policy is not intended nor designed for use in care such as pain control, for sedation of patients on ventilators, or when such agents are used to reduce anxiety.

It is not the purpose of this policy to include reasonable (dosages that are not excessive or contraindicated) oral pre-operative medications.

PROCEDURE FOR PRIVILEGING AND SKILL COMPETENCY

	Physicians who want privileges to administer IV conscious sedation must obtain approval from their department director and be credentialed by the Credentials Committee in accordance with the Medical Staff bylaws.
	Privileges to administer IV conscious sedation will be recommended by the Credentials Committee and granted by the Board of Trustees consistent with the Medical Staff bylaws and the following requirements:

Minimum Credentialing for conscious sedation include:

	Current Advanced Cardiac Life Support (ACLS) Certification
	New members of the Medical Staff must provide documentation that they have been trained in IV Conscious Sedation and have managed at least ten cases within the past five years.

Recredentialing

	Has successfully completed an ACLS course in the previous five years
	Has managed a minimum of five cases per year
	Has demonstrated clinical competency based on Performance Improvement (PI) records
	All IV conscious sedation will be ordered and supervised by a physician credentialed and having approved privileges for the specific procedure and administration of the anesthetic used in conscious sedation.
	The licensed professional nurse (R.N.) Must have the following qualifications to assist physicians with procedures requiring sedation:

Current ACLS or

BCLS as well as Cardiac Emergency Course (CEC)

IV certification

Demonstrated competency and documented evaluation

Satisfactory completion of competency for sedation

All patients requiring IV conscious sedation will have a pre-procedure assessment, a minimal preanesthetic assessment including, but not limited to:

A medical evaluation based on a history and physical performed by a licensed independent practitioner with privileges to perform histories and physicals. (This should include documentation of family history, psycho social history, current medications and a history of any adverse or allergic drug reactions, including anesthesia or sedation, other allergies, NPO status, and an ASA assessment.)

Indications/symptoms for procedure requiring conscious sedation

Assessment of the patient’s ability to tolerate conscious sedation

Laboratory studies as indicated by the patient’s past medical history and present illness

An accurate, valid, signed informed consent for the procedure with documentation of risks/benefits/alternatives, and plan for sedation as discussed with patient/significant other

Age appropriate assessment, including baseline set of vital signs and a pre-procedure SPO2

Patients exhibiting hemodynamic instability, oxygen desaturation, or respiratory depression/failure are not appropriate candidates for IV conscious sedation unless monitored anesthesia care (MAC) can be provided or the procedure is done in a critical care area. Arrangements for MAC should be made as early as possible through the operating room scheduling desk.

IMMEDIATELY PRIOR TO INITIATION OF CONSCIOUS SEDATION

Prior to the initiation of conscious sedation, the following assessments are determined, monitored, and documented:

Level of consciousness and mental status

Vital signs: heart rate, blood pressure, respiratory rate, and oxygen saturation

NPO Status

Pregnancy (as appropriate)

Baseline Aldrete scale (documented by the R.N.)

Peri procedure monitoring, patient care, and treatment including medications administered (documented by the R.N. on the Sedation Record Form).

EQUIPMENT AVAILABILITY AND EMERGENCY MANAGEMENT

The following age appropriate equipment/emergency drugs shall be immediately available (Code Carts) prior to IV conscious sedation being administered:

Oxygen source

Ambu bag

Laryngoscope

Endotracheal Tubes (i.e. sizes 5.0 mm, 6.0 mm, 7.0 mm, 8.0 mm)

Oral and nasal airways

Emergency drugs (Narcan, Romazicon)

Cardiac monitor/defibrillator and suction equipment

Pulse Oximeter

STAFFING

Staffing during conscious sedation includes a minimum of:

One physician or CRNA who has approved privileges to administer conscious sedation with the competencies listed within the following bullet.

One qualified practitioner or registered nurse to monitor the patient. This person must possess and must have demonstrated the following knowledge, skills, and competencies:

Familiarity with proper dosages, administration, adverse reactions, and interventions for adverse reactions and over dosages

Knowledge of how to recognize airway obstruction and demonstrate skills in advance life support

	Ability to assess total patient requirements or parameters, including, but not limited to respiratory rate, oxygen saturation, blood pressure, cardiac rhythm/rate and level of consciousness
	Knowledge and skills to intervene in the event of complications

	Also see above section entitled “PROCEDURE FOR PRIVILEGING AND SKILL COMPETENCY”.
	Additional staffing is based on the patient’s acuity, procedure, and the potential response to the medications being administered.

MEDICATIONS:

A physician with or CRNA with privileges in the administration of conscious sedation selects and orders the medication.

A physician with or CRNA with privileges in the administration of conscious sedation must be present during the initial and continued administration of IV sedation.

An R.N. or anyone not certified in anesthesia may not administer medications classified as anesthetics, including, but not limited to Ketamine, Propofol, Sodium Pentothal and Brevital, except in an emergency situation when requested to do so by a physician privileged to administer such anesthetics or an anesthesiologist or CRNA. In such instances, the physician, anesthesiologist, or CRNA must be physically present at the time of the request and must continue to remain with the patient after the administration of the drug.

The recommended dosages are as follows:

Fentanyl (Sublimaze) 1-2 meg/kg 1meg/kg

Care is taken to assure that the total dose does not obtund protective pharyngeal reflexes or render the patient unresponsive to verbal stimuli.

INTRA-PROCEDURE MONITORING AND CARE

The physician will order the sedation medication and administer the initial dose. The Registered Nurse may administer subsequent medication, except as noted above.

Cardiac monitoring and oxygen saturation are to be monitored continuously and documented every 5 minutes.

Blood pressure, pulse, respiration, heart rate/rhythm will be taken and documented at least every five minutes, or more frequently depending upon changes in the patient’s condition.

The patient will also be monitored for potential adverse reactions to the medications being administered. Any signs or symptoms of adverse reactions are to be reported immediately to the attending physician.

Level of consciousness will be monitored and documented.

Supplemental oxygen will be administered if oxygen saturation is less than 95%.

Administered drugs should be recorded, including route, time, and dosage.

If patient demonstrates persistent oxygen desaturation

(SaO2 less than 90%) despite the use of supplemental oxygen, or requires airway support, the case should be terminated unless an anesthesiologist is available to provide monitored anesthesia care.

IV access must be maintained at all times.

IMMEDIATE POST PROCEDURE MANAGEMENT

Patients should go to an appropriate post-anesthesia care area, transported by a physician and a registered nurse.

Vital signs (which include: heart rate, blood pressure, respiratory rate, level of consciousness, and oxygen saturation) will be taken every five to fifteen minutes until the patient reaches the defined discharge criteria. Heart rate/rhythm will be monitored by a cardiac monitor. Post sedation assessment shall also include patient’s orientation.

Significant variations in physiologic parameters are to be reported to the physician immediately. These shall include, but not be limited to:

A variation of plus or minus 20% in vital signs

Serious arrhythmia

Oxygen saturation greater than 5% below baseline

Dyspnea, apnea, or hypoventilation

Diaphoresis, inability to arouse patient, or the need to maintain the patient’s airway

Other untoward or unexpected patient responses

The decision for discharge will be guided by the following criteria and the order will be written by a physician when the patient reaches a score of seven (7) on the Aldrete scale:

Discharge to original nursing unit or routine monitoring:

Patient is able to be aroused

Blood pressure, heart rate, and respiration are stable for at least two sets (q 15 min.) and have returned to pre-procedure status

Oxygen saturation is back to or near baseline

Minimum of two minutes since last dose of medication

Discharge to home:

All of the above criteria are met.

Patient is oriented times 3 and ambulates without difficulty.  (If these were skills prior to procedure)

Patient is able to verbalize appropriately; stands and dresses self. (If these were skills prior to procedure)

Patient has minimal/tolerable pain level

Patient has no nausea, vomiting, or bleeding.

Patient must have a responsible adult to accompany him home. In no case should the patient be allowed to drive himself/herself home. For the purpose of this section, a cab or bus driver is not considered a responsible adult.

Patient has received written discharge instructions related to procedure, limitations, etc.

POST PROCEDURE MANAGEMENT

Patient is not discharged without a designated driver, if any sedation has been given.

Patient is to be instructed not to drive, sign legal documents, or operate dangerous machinery for 24 hours after the procedure.

Discharge instructions are to be provided both verbally and in writing to the outpatient and/or responsible person regarding diet, medications, not using alcohol, activities, and signs and symptoms of complications with the course of action to take if any complications arise. If the procedure is done in the Emergency Department, a copy of the emergency room record and the Emergency Room physician's dictation which includes the discharge instructions are to be forwarded to the physician involved in follow-up care of the patient.

MEDICAL RECORD DOCUMENTATION

Allergies

Level of consciousness

Monitoring devices or equipment used

Physiologic data from continuous monitoring, documented at defined intervals (no less than every 15 min. unless otherwise, as noted above) and at any significant event

Dosage, route, time, and effects of sedative medications

Any interventions, such as oxygen or intravenous therapy, and the patient’s response

Any untoward or significant reactions and resolutions

Patient/family instructions and education provided

Area to which patient is transferred, mode of transfer, and nurse receiving report

Circumstances of discharge home: who accompanied patient, time, discharge instructions given, vital signs upon discharge

PERFORMANCE IMPROVEMENT METHODS

The Director of each clinical department wherein physicians administer or direct the administration of IV conscious sedation is responsible for the individual monitoring and evaluation of its use.

The Chairman of Anesthesia or designee is responsible to oversee the overall monitoring and evaluation of conscious sedation use at this Hospital.

There will be a program of performance improvement for IV conscious sedation integrated into the Hospital’s Performance Improvement Program.

Findings from the monitoring and evaluation of IV conscious sedation shall be included in the Performance Improvement process as appropriate within each clinical department that uses conscious sedation.

Adverse outcomes, (any patient requiring admission to the hospital, any patient suffering cardiac or respiratory arrest, any death), associated with the use of IV conscious sedation will be reviewed as part of the systematic ongoing Performance Improvement Program in each department where IV conscious sedation is administered.

It is the responsibility of the physician who administers conscious sedation to complete an occurrence report whenever there is an adverse event. The original report must be forwarded to the Risk Manager within 24 hours. Copies of the report must also be sent to the Chairperson of his/her department and to the Chairperson of Anesthesiology.

Deaths and/or unexpected intraoperative or postoperative events or outcomes related to conscious sedation in any anesthetizing location must be reported to the Director of Anesthesiology and to the Vice President of Medical Affairs who will assure that any reporting that may be required under state law is addressed.