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  VA Medical Center                   Memorandum XXX

                                      Date
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Subject: SEDATION AND ANESTHESIA CARE POLICY

1\. PURPOSE

To provide guidelines for personnel who administer sedation or
anesthesia to patients undergoing surgical or diagnostic procedures or
treatments, regardless of the location where the surgery, procedure or
treatment occurs.

2\. POLICY

a\. Anesthesia care is defined by four levels of sedation and anesthesia
(minimal, moderate sedation/analgesia, deep sedation/analgesia, and
anesthesia).

b\. Anesthesia care will be provided by qualified individuals with
appropriate credentials. Because it is not always possible to predict
how an individual patient receiving medication with the intent to
achieve moderate or deep sedation will respond, qualified individuals
will be trained in professional standards and techniques

\(1\) to administer pharmacologic agents to predictably achieve desired
levels of sedation, and

\(2\) to monitor patients carefully in order to maintain them at the
desired level of sedation.

c\. Individuals administering moderate sedation, deep sedation or
anesthesia will be qualified and have the appropriate credentials to
manage patients at whatever level of sedation or anesthesia is achieved,
either intentionally or unintentionally.

3\. DEFINITIONS

a\. LEVEL 1 - Minimal sedation (anxiolysis) -- a drug-induced state
during which patients respond normally to verbal command. Although
cognitive function and coordination may be impaired, ventilatory and
cardiovascular functions are unaffected.

b\. LEVEL 2 - Moderate sedation/analgesia (previously termed \"conscious
sedation\") -- a drug-induced depression of consciousness during which
patients respond purposefully to verbal commands, either alone or
accompanied by light tactile stimulation. (Note: reflex withdrawal from
a painful stimulus is not considered a purposeful response.) No
interventions are required to maintain a patent airway, and spontaneous
ventilation is adequate. Cardiovascular function is usually maintained.

c\. LEVEL 3 - Deep sedation/analgesia -- a drug-induced depression of
consciousness during which patients cannot be easily aroused but respond
purposefully following repeated or painful stimulation. The ability to
independently maintain ventilatory function may be impaired. Patients
may require assistance in maintaining a patent airway and spontaneous
ventilation may be inadequate. Cardiovascular function is usually
maintained.

d\. LEVEL 4 - Anesthesia -- consists of general anesthesia and spinal or
major regional anesthesia. It does not include local anesthesia. General
anesthesia is a drug-induced loss of consciousness during which patients
are not arousable, even by painful stimulation. The ability to
independently maintain ventilatory function is often impaired. Patients
often require assistance in maintaining a patent airway, and positive
pressure ventilation may be required because of depressed spontaneous
ventilation or drug-induced depression of neuromuscular function.
Cardiovascular function may be impaired.

e\. Advanced Life Support - Advanced life support is defined as the
ability to maintain a patent airway in an unconscious patient, the
ability to ventilate an unconscious patient, and the ability to diagnose
and initiate treatment for life threatening arrhythmias and/or cardiac
arrest.

4\. PROCEDURE

a\. Level 1, minimal sedation, as addressed in this policy will refer to
the use of drugs with anxiolytic effects in doses below those reasonably
expected to affect ventilatory and cardiovascular functions. Level 1
sedation may be administered by any practitioner with appropriate
clinical privileges. No special monitoring or facilities are required
other than maintaining verbal or visual contact with the patient until
the effects of the medication have reached their peak.

b\. Level 2, moderate sedation/analgesia as defined here, specifically
excludes administration of sedative-hypnotic or analgesic medication
under emergency conditions, postoperative analgesia, or when not
associated with a specific medical procedure or treatment. Moderate
sedation will be administered under the immediate direct supervision of
***a physician or dentist (Local facility must decide if other providers
can supervise and/or perform moderate sedation)*** who is clinically
privileged to perform moderate sedation. Moderate sedation will be
administered ONLY in areas of the medical center where trained,
qualified staff and appropriate equipment are present. The decision to
use moderate sedation and the selection of drugs to be used will be made
only by appropriately privileged providers.

c\. Level 3, deep sedation/analgesia and Level 4, anesthesia, will be
administered only by an anesthesiologist holding appropriate clinical
privileges, or a certified registered nurse anesthetist (CRNA) working
in conjunction with an appropriately credentialed anesthesiologist.
***Note: Facilities without anesthesiologists will need to modify this
section to reflect the local practice, such as CRNA in conjunction with
a physician. You need to be aware of the State license held by your CRNA
to be sure appropriate supervision is being offered.***

d\. Patients throughout the Medical Center will receive a comparable
level of care, regardless of the level of anesthesia care administered.

e\. Individuals administering, monitoring, and/or supervising moderate
sedation must have documented competency-based education, training, and
experience in, at a minimum, the following:

\(1\) Evaluating patients before performing moderate sedation.

\(2\) Performing the moderate sedation, including rescuing patients who
slip into deep sedation. This must include the ability to manage a
compromised airway and to provide adequate oxygenation and ventilation.

\(3\) The pharmacokinetics of the drugs typically used for moderate
sedation as well as the potential effects of the drugs on vital
functions.

\(4\) Cardiopulmonary resuscitation (CPR), airway management, and
management of cardiac arrhythmias. This requirement may be satisfied by
successful completion of Advanced Cardiac Life Support (ACLS) training
or equivalent training.

\(a\) Periodic re-training or renewal of this training must be obtained
as recommended by the American Heart Association or other training
entity.

\(b\) New providers that administer, monitor, or supervise moderate
sedation or perform procedures that require moderate sedation must have
had, or must complete, this training within 90 days of employment with
VA.

\(c\) As of September 30, 2006, current VA providers must complete this
training by the time of reappraisal for privileging, if they administer,
monitor, or supervise moderate sedation, or perform procedures that
require moderate sedation.

f\. The moderate sedation training and competency will be documented and
reflected in the individual's privileges or scope of practice. Further,
as part of a clinician's re-privileging or updating of his/her Scope of
Practice, the clinician must show evidence of understanding of current
CPR standards and techniques.

g\. Assessment and Monitoring of Patient

\(1\) Pre-procedure

\(a\) Staff privileged to provide moderate sedation will be involved in
planning for and providing moderate sedation care to the patient. The
patient chart needs to include an appropriate history and a physical
done, or updated, within 30 days of the procedure. All assessments of
patients undergoing moderate sedation must be signed by a licensed
independent practitioner (LIP) prior to sedation. A pre-sedation
assessment must be performed (which may include the relevant history and
physical). The combination of the history and physical along with the
pre-sedation assessment must, at a minimum, include:

[1]{.underline}. a review of abnormalities of the major organ systems,
with a focused physical examination including vital signs, auscultation
of the heart and lungs, and assessment of the airway.

[2]{.underline}. a review of any previous adverse experience with
sedation/analgesia as well as regional and general anesthesia.

[3]{.underline}. a review of drug allergies, current medications and
potential drug interactions.

[4]{.underline}. a review of tobacco, alcohol or substance use or abuse.

[5]{.underline}. time and nature of last oral intake.

[6]{.underline}. an assessment of risk such as the American Society of
Anesthesiologists Physical Status.

\(b\) The plan developed and the patient\'s sedation or anesthesia care
needs will be communicated among care providers.

\(c\) Immediately before the induction of sedation or anesthesia,
re-evaluate the patient, review the medical record and determine the
patient is an appropriate candidate to undergo the planned sedation or
anesthesia. This re-evaluation must be documented in the patient's
record. The re-evaluation must include documentation of pre-procedure
vital signs.

\(d\) For any location in which moderate sedation is administered, the
following equipment must be available in the immediate area and
functioning:

[1]{.underline}. blood pressure monitoring device

[2]{.underline}. pulse oximeter

[3]{.underline}. source of supplemental oxygen and apparatus for
delivery

[4]{.underline}. suction apparatus with appropriate suction catheters

[5]{.underline}. defibrillator and code cart immediately available to
procedure room

[6]{.underline}. equipment to administer IV fluids and drugs, including
blood and blood components, as needed

\(e\) Informed Consent will be obtained, after discussing with the
patient the risks, benefits, potential complications, any alternative
options associated with the planned procedure, and the need to
administer blood or blood components.

\(f\) For patients undergoing outpatient procedures, a responsible adult
will be identified beforehand and be present to escort the patient home.
Or if necessary the patient may be sent to lodging. The patient may not
be discharged home on their own recognizance.

\(g\) Sedation or anesthesia will be administered under the immediate
direct supervision of a physician or dentist ***(Local facility must
decide if other providers can supervise moderate sedation)*** who has
been specifically privileged to administer and manage the level of
sedation achieved.

\(h\) Baseline information which at a minimum includes level of
consciousness, oxygen saturation, respiratory rate, heart rate, blood
pressure, and weight, will be obtained and recorded prior to
administration of medication for sedation or anesthesia.

\(2\) Intra-procedure

\(a\) A sufficient number of qualified staff ([in addition to the
individual performing the procedure]{.underline}) must be present to
evaluate the patient, help with the procedure, provide the sedation,
monitor, and recover the patient. The person performing the procedure
cannot be the primary individual monitoring the patient.

\(b\) During moderate sedation, drugs that are anesthetic agents (e.g.
propofol, thiopental, methohexital, ketamine, etomidate, etc.) must be
administered by an anesthesiologist, nurse anesthetist or by a licensed
independent practitioner with the training and ability to rescue a
patient from general anesthesia.

\(c\) The patient\'s physiological status will be monitored intra- and
post-sedation or anesthesia administration. Requirements include:
continuous monitoring of respiratory rate, adequacy of pulmonary
ventilation, and pulse oximetry; measurement of heart rate and blood
pressure at regular intervals. For patients with significant
cardiovascular disease or when dysrhythmias are anticipated or detected,
cardiac monitoring by EKG or use of continuous cardiac monitoring
device.

\(d\) All monitoring will be documented on a written record prior to
administration of medication, and at least every five minutes thereafter
throughout the procedure (Exceptions to this requirement and the reason
for such exceptions must be documented). In the recovery phase,
monitoring will continue at least every 15 minutes, for a minimum of 30
minutes, after the last drug administration for sedation or anesthesia.
Monitoring will continue for a minimum of 90 minutes if the patient has
required naloxone or flumazenil.

\(e\) The patient\'s response to care provided throughout the procedure
will be documented in the patient\'s medical record. Intra-procedure
documentation will include:

[1]{.underline}. dosage, route, drugs and agents utilized

[2]{.underline}. evidence of continuous monitoring

[3]{.underline}. record of any unusual occurrence(s) during
sedation/anesthesia

\(f\) The patient's status must be assessed immediately after the
procedure is completed. The assessment, which must be documented, is to
include monitoring physiological status, mental status and pain level.

\(g\) Immediate post-procedure monitoring, including during transport to
the recovery area, is at a level consistent with the status of the
patient and the potential effect of the procedure or sedation.

\(3\) Post-procedure

\(a\) The patient\'s post-procedure status will be assessed on admission
to and before discharge from the post-sedation or post-anesthesia
recovery area. Post-procedure documentation will include:

[1]{.underline}. Status of patient on admission to post-sedation or
post-anesthesia recovery area

[2]{.underline}. Vital signs and level of consciousness

[3]{.underline}. Unusual events or post-procedure complications during
post-sedation/anesthesia management of care

\(b\) The patient will be discharged from the post-sedation or
post-anesthesia recovery area upon the written order from a qualified
licensed independent practitioner or using objective criteria such as
the Aldrete Score (attachment A) rigorously applied to the patient's
status. When approved criteria are used, compliance with the criteria
will be fully documented in the patient\'s medical record. Once a
patient meets clinical discharge criteria, the patient may be discharged
home (outpatient) in the care of a responsible adult, or discharged to
lodging (overnight stay), or transferred to the ward (inpatient).

h\. Monitoring and Evaluation of Care

\(1\) Outcomes of patients undergoing moderate or deep sedation will be
collected, aggregated and analyzed to enhance patient safety and
performance. ***(Note: The local policy may want to specify how the data
is collected and to which local body it is reported, as well as a
statement that the responsible local body will use the data to enhance
patient safety and performance)*** Monitoring and evaluation activities
will include:

\(a\) Evaluation of documentation compliance

\(b\) Review of all cases requiring unplanned ventilator assistance
post-procedure

\(c\) Review of all unanticipated hospital admissions or admission to
ICU from a ward after a procedure

\(d\) Review of all cardiac or respiratory arrests as related to
moderate or deep sedation and anesthesia

\(e\) Review of all cases of moderate or deep sedation requiring
reversal of narcotic or sedative medication with naloxone or flumazenil.
Use of a reversal agent is not considered de facto evidence of an
adverse outcome.

\(2\) Moderate sedation adverse events must be reported, reviewed,
trended and analyzed in conjunction with OR anesthesia adverse events
and the data used to improve performance.

\(3\) Suspected adverse drug events will be documented. Pharmacy will be
notified as per local policy.

5\. RESPONSIBILITIES

a\. Chief, Anesthesia Service ***(or Section) -- Potential
responsibilities are: responsible for oversight of the Sedation and
Anesthesia Care policy and assures Anesthesiology staff are available
for consultation regarding moderate sedation. Assists services in
monitoring and evaluating sedation and anesthesia care practices.
Assists in providing training for persons involved in physiologic
monitoring of sedated patients.***

b\. Chiefs of Services using Moderate Sedation - responsible for
assuring that service-specific procedures are developed for all areas
within their service in which moderate sedation is carried out. Provide
regular review and appropriate quality improvement activities with
respect to moderate sedation monitoring and practices. Determine
necessary credentials for privileging of moderate sedation providers
within the service.

c\. Individual Practitioners Providing Sedation or Anesthesia --
responsible for overall supervision of the administration and rendering
of sedation or anesthesia in compliance with the policy and procedures
for sedation and anesthesia care. Specifically, responsible for
preoperative evaluation of the patient, including the determination that
the patient is an appropriate candidate to undergo the planned
procedure. Responsible for discharging patients from the post-sedation
or post-anesthesia recovery area. Responsible for the accuracy and
completion of documentation pre-, intra-, and post-sedation management.

d\. Chief of Staff -- responsible for the quality of sedation and
anesthesia care provided to patients throughout the Medical Center.

e\. Medical Center Director -- responsible for approving privileges of
individuals providing sedation and anesthesia care.

6\. REFERENCES

7\. RESCISSION:

8\. EXPIRATION DATE: XXX

9\. FOLLOW-UP RESPONSIBILITY: Chief, Anesthesia

// signed//