Patient Care & Safety

Pre-Procedure Assessment	Personnel & Equipment
Herbal Supplements	Airway Management
Patient Monitoring	RASS
Ramsey Scoring System	Recovery & Discharge
Risks & Complications	Sources

Pre-procedure Moderate Sedation Assessment (Pediatric, Adult and Geriatric)

A comprehensive pre-procedure preparation is essential to safe endoscopic moderate sedation. Standardized nursing assessment and interventions before, during and following a procedure should be included:

Physical status (review of systems, vital signs, airway and cardiopulmonary reserve – i.e. Obstructive Sleep Apnea; did patient bring CPAP equipment to procedure?)
Medication history/allergies – e.g.. cardiac, hypertensive, diabetic, anticoagulants and narcotics; Did patient take and hold AM medications as instructed? (See also Patient Safety Issues with Herbal Supplements)
dverse reactions with sedation and analgesia – i.e. conscious, monitored anesthesia care, regional and/or general anesthesia. Is there a family history of anesthesia complications, i.e. malignant hypertension, and does today’s sedation seem appropriate given patient’s medical, ASA 3 and 4: Consider anesthesia and medical clearance
Relevant diagnostic studies – e.g. H & H, platelet count, INR
History of tobacco, alcohol and substance abuse – is patient actively using illicit drugs?
Verification of NPO status and bowel preparation adherence
Discharge instructions – responsible person and transportation need to be been verified
Immediately prior to sedation/informed consent and time out should be verified

Summary of American Society of Anesthesiologists Pre-procedure Fasting Guidelines

Ingested Material: Clear Liquids
Minimum Fasting Period: 2 hours

Ingested Material: Breast Milk
Minimum Fasting Period: 4 hours

Ingested Material: Instant Formula
Minimum Fasting Period: 6 hours

Ingested Material: Nonhuman Milk
Minimum Fasting Period: 6 hours

Ingested Material: Light Meal
Minimum Fasting Period: 6 hours

These recommendations apply to healthy patients who are undergoing elective procedures. They are not intended for women in labor. Following the guidelines does not guarantee complete gastric emptying
The fasting periods noted above apply to all ages
Examples of clear liquids include: water, fruit juices without pulp, carbonated beverage, clear tea and black coffee
Since non-human milk is similar to solids in gastric emptying time, the amount ingested must be considered when determining an appropriate fasting period
light meal typically consists of toast and clear liquids. Meals that include fried or fatty foods or meat may prolong gastric emptying time. Both the amount and type of foods ingested must be considered when determining appropriate fasting period

Personnel and Equipment

For more information, please view the following position statements:

Before sedating a patient, the appropriate personnel should be present:

A registered nurse with appropriate training in endoscopic sedation should be dedicated to administering sedative drugs and monitoring the patient throughout the procedure. During moderate sedation, this individual may assist with minor interruptible tasks. When deep sedation is planned, this person should be dedicated exclusively to observation and monitoring. This individual should possess:
An understanding of the levels of sedation
The ability to monitor and interpret the patient’s physiologic parameters
Current certification in basic or advanced life support
Skills to initiate the proper intervention in the case of a complication related to sedation
At least one individual with training in advanced cardiac life support (tracheal intubation, defibrillation, use of resuscitation mediation, ACLS) that is capable of establishing an airway and providing positive-pressure ventilation
See also the American Society of Anesthesiologists document, Granting Privileges for Administration of Moderate Sedation to Practitioners Who Are Not Anesthesia Professionals, Statement on (2011).

Emergency equipment must be immediately available whenever sedation and analgesia are being performed

The equipment should be appropriate for the practice environment (i.e. size-appropriate equipment where pediatric endoscopy is being performed) and for the training of the sedation team
It is strongly recommended that a cardiac defibrillator be available onsite
Equipment for providing positive airway pressure must be immediately available (see below)

Emergency Resuscitative Equipment

Assorted syringes, tourniquets, adhesive tape
Intravenous access equipment including fluids
Basic airway management equipment
- Oxygen supply
- Suction machine and catheter
- Nasal cannulae and face masks*
- Bag-mask ventilation device
- Oral and nasal airways (all sizes)
Advanced airway management equipment
- Laryngoscope handles and blades*
- Endotracheal tubes and stylets*
- Laryngeal mask airway (LMA)*
Cardiac Equipment
- Pulse oximeter
- Cardiac defibrillator
- Emergency medications
- Atropine
- Diphenhydramine
- Epinephrine
- Ephedrine
- Flumazenil
- Glucose, 50%
- Hydrocortisone
- Lidocaine
- Naloxone
- Sodium bicarbonate

*All appropriate sizes should be available

Patient Safety Issues with Use of Herbal Supplements

Herbals are just one type of dietary supplements as defined by the Food and Drug Administration (FDA). According to the FDA, a dietary supplement is defined as a product that contains one or more dietary ingredient such as:

a vitamin or a mineral
an herb or other botanical
an amino acid
a dietary substance intended to increase the total dietary intake
a concentrate, metabolite, constituent, extract
a combination of the above ingredients

Risks of Herbal Supplements

There is no systematic scientific methodology to evaluate possible interactions between herbal supplements and medications that might be prescribed by a physician. As a result, information and recommendations are largely based on the aggregate of animal studies, case reports, historical contraindications, extrapolation from basic pharmacology data and the occasional clinical trial. Much of the information on adverse effects related to herbal supplements has focused around the following problems:

Liver toxicity from pyrrolizidine alkaloid compounds found in some plants
Nephrotoxity induced by some Chinese herbs, in particular aristolochia, which may also be associated with urothelial cancers
Cardiac events have been associated with ephedra alkaloids. Ephedra has been banned by the FDA and is no longer legally available in the USA. Nevertheless, all clinicians should be aware of its risks, as patients may acquire ephedra when abroad

Warfarin is the most common physician prescribed pharmaceutical cited to have negative interactions with herbals. St. John's Wort is the most frequent herbal product reported as being associated with adverse interaction effect with drugs.

In addition, herbal supplements that are not known to cause adverse effects when taken at the recommended doses may have toxic effects if extremely high doses are used. Licorice and ginseng in particular have been associated with toxicities from overuse.

(FDA) has classified the following supplements as high risk and therefore need be avoided by all patients:

Ephedra or ephedrine
Chaparral
Comfrey
Gamma butyrolactone

Perioperative Concerns

Preprocedure assessment of herbals should commence in the primary care setting before the patient is actually referred to gastroenterology for a procedure. By the time the patient arrives to his/her procedure, it may already be too late to stop potential drug-to-drug interactions with herbals.

The assessment of the patient scheduled to undergo sedation for a procedure includes a history and physical exam. Many patients do not tell their doctor about dietary supplements they may be taking, in part because physicians may not be as knowledgeable about supplements, and patients may fear the physician will be unhappy about the patient using nonconventional therapy. However, doctors and nurses need to know if the patient is taking any supplements because the risk of complications from herbal supplements may be elevated in the perioperative period. This is because of potential interactions between herbals the patient is taking and the anesthesia drugs and other medications that may be administered during the procedure. Also, herbs may contain contaminants and/or other unknown ingredients.

Rare complications that might in part be due to supplements include myocardial infarction and stroke (i.e. ephedra) liver injury (i.e., echinacea,kava), ineffective anticoagulation and bleeding (i.e. garlic and gingko), prolonged or inadequate anesthesia (i.e. kava) and rejection of organ transplant (i.e. St. John’s wort). As a result it is generally recommended to avoid herbal supplements for 2 weeks prior to a surgical procedure and anesthesia.

The following is a list of common supplements that are of particular concern with regard to the perioperative period.

Most commonly used by US adults in 2002 National Health Interview Survey (NHIS) and known to affect surgical outcomes:
- Echinacea
- Ephedra
- Feverfew
- Garlic
- Ginger
- Ginseng
- St. John’s Wort
Other supplements of concern:
- Chondroitin
- Glucosamine
- Fish oil
- Ginkgo biloba
- Goldenseal
- Kava
- Licorice
- Milk thistle
- Saw Palmetto
- Valerian
- Vitamin E

Medication Effect	Drug	Herb	Interaction
Stimulants	caffeine, decongestants (Sudafed, Actifed, etc.)	ephedra, yohimbine, guarana, ginseng	Potentiate stimulation
Sedatives	alcohol, benzodiazepines, barbituates	valerian, kava, St. John's wort	Potentiate sedation
Platelet aggregation	warfarin, aspirin, clopidogrel, dipyridamole, ticlopidine	garlic, ginger, gingko, feverfew, ginseng	Potentiate anticoagulant effect
Antidepressant	SSRI drugs, phenelzine sulfate, sertraline, citalopram, bupropion, tranylcypromine sulfate	St. John's wort	Serotonin syndrome, Monoamine oxidase inhibitors (MAOI) interaction potentially leading to mental effects such as confusion, as well as shivering, sweating, fever, muscle twitching
Hypoglycemics	insulin, all antidiabetics	bilberry, bitter melon, dandelion, garlic	Potentiates lowering of glucose levels
Immunostimulant	anabolic steroids, amiodarone, HIV drugs	echinacea, astragalus	Decrease action of corticosteroids; may interfere with immunosuppression

Sedation Airway Management

Introduction:

The drugs used for sedation and analgesia can interfere with a patient's ventilation both by relaxing the airway muscles and suppressing the urge to breathe
The primary risk related to sedation is respiratory complications
Ability to maintain a patent airway is an essential prerequisite for administration of sedation
Airway obstruction can be either total or partial

Symptoms of Partial Airway Obstruction

Snoring
Rocking motion of the chest not in sync with respiratory effort
Harsh, high-pitched sound upon inspiration (stridor)
Hypoxemia
Hypercarbia

Symptoms of Complete Airway Obstruction

Lack of any air movement perceived by feeling with the hand over the mouth or placing the ear over the mouth
Lack of breath sounds while listening with stethoscope to lung fields
Retraction of the sternum and rib cage
Rocking motion of the chest not in sync with respiratory effort
Hypoxemia
Hypercarbia

Airway Anatomy

Normal respiration relies on a series of structures that conduct air into and out of the lungs. An understanding of the functional anatomy of this region is critical to airway management.

Upper airway

The upper airway consists of the structures above the vocal cords. It is divided into the following regions:

Nose and oral cavity
Pharynx – The pharynx is divided into three sections:
- Nasopharynx
- Oropharynx
- Laryngopharynx
Trachea
Bronchial tree
Lungs

Basic Airway Management

Immediate action must be taken at the first signs of compromised respiratory function.

If initial attempts to relieve airway obstruction through verbal and tactile stimulation are unsuccessful, the following techniques can be employed to restore effective ventilation:

Manual Maneuvers

When the muscles of the tongue and mouth floor relax, the tongue lies close to or on the back wall of the oropharynx
The epiglottis may obstruct the glottic opening or seal against the back wall of the pharynx, as well
The following positioning maneuvers can be performed to relieve the soft tissue obstruction and improve airflow.
- Jaw thrust
  - This maneuver moves the tongue forward with the mandible which reduces the tongue's ability to obstruct the airway
  - Stand at the head of the bed
  - The middle finger of the right hand is placed at the angle of the patient's jaw on the right
  - The middle finger of the left hand is similarly placed at the angle of the jaw on the left
  - An upward pressure is applied to elevate the mandible which will lift the tongue from the posterior pharynx.

Artificial airway devices

Both devices maintain a patent airway by preventing the tongue from resting against the posterior pharyngeal wall
- Oropharyngeal airway (OPA)
  - Curved, firm, hollow tube used to maintain a conduit between the mouth and the glottis and to prevent obstruction by the tongue
  - Should be used in unconscious (unresponsive) patients as they are quite stimulating and generate a gag reflex
  - In responsive patients OPAs can cause vomiting and aspiration
    Incorrect insertion of an airway can push the tongue into the back of the throat causing airway obstruction
  - To select the proper size OPA, place it against the side of the face. When the tip of the OPA is at the corner of the mouth, the phalange is at the angle of the mandible
- Nasopharyngeal airway (NPA)
  - Also called a "nasal trumpet," is a soft rubber or plastic hollow tube that is passed through the nose into the posterior pharynx just above the epiglottis
  - Are better tolerated by patients compared to OPA
  - Can be used when OPA placement is difficult, such as when the patient's jaw is clenched or the patient is semiconscious and cannot tolerate an OPA.
  - The length of the NPA should be the same as the distance from the tip of the patient’s nose to the earlobe.

Bag-mask ventilation

Bag-mask ventilation is a basic but critical airway management skill
Successful bag-mask ventilation depends on three things:
- Patent airway. Airway patency can be established using airway maneuvers and airway conduits described above.
- Adequate mask seal
  - In order to secure a good seal, the mask must be placed and held correctly
  - The nasal portion of the mask should be spread slightly and placed on the bridge of the patient's nose
  - The body of the mask is then placed onto the patient's face covering the nose and mouth
  - The provider's wrists or the mask cushion should not rest on the patient's eyes during bag-mask ventilation
- Proper ventilation (i.e., proper volume, rate, and cadence)
  - The three key errors to avoid when performing bag-mask ventilation are:
    - Excessive tidal volumes: A volume just large enough to cause chest rise
      - During cardiopulmonary resuscitation (CPR), even smaller tidal volumes are adequate (5 to 6cc/kg) due to the reduced cardiac output of such patients
    - Forcing air too quickly: The bag should not be squeezed explosively. It should be squeezed steadily over approximately one full second
    - Ventilating too rapidly. The ventilatory rate should not exceed 10 to 12 breaths per minute

Advanced Airway Management

Cases where non-invasive means are insufficient to provide adequate oxygenation and ventilation, a clinician may need to use one of the following advanced airways:

Endotracheal tube (ETT)
- Indicated for airway protection in a comatose patient for example, for mechanical ventilation, and if pulmonary toilet is necessary
- It is the definitive method to secure a compromised airway, prevent aspiration, and initiate mechanical ventilation
- Placement typically requires laryngoscopy

Physical Assessment

The pre-procedure physical examination should include the following assessments to evaluate the patient’s airway and uncover physical traits that could contribute to respiratory complications:

Oral cavity inspection – The patient's oral cavity should be carefully inspected for the following abnormalities prior to sedation. Findings should be documented in the patient's record

Small mouth opening (less than 3cm in an adult)
Protruding incisors
Loose or capped teeth
Enlarged tongue
Missing teeth
Dental appliances such as crowns, bridges, and dentures
Enlarged tonsils
Non-visible uvula
Tumor that could obstruct air flow
Document Mallampati score base on the following:
- Mallampati Airway Classification System:
  - This system is a method for quantifying the degree of difficulty of endotracheal intubation based on amount of posterior pharynx that can be visualized
  - The exam is performed with the patient sitting with the head in a neutral position and the mouth open as wide as possible

Class I: soft palate, fauces, uvula, pillars visible. No difficulty.
Class II: soft palate, fauces, portion of the uvula visible. No difficulty.
Class III: soft palate, base of uvula visible. Moderate difficulty.
Class IV: hard palate only. Severe difficulty.

Neck mobility

Assessment of the movement through flexion, extension, and side to side is necessary before sedation is initiated
Significant obesity especially in the region of the neck and face
Short, immobile neck
Recessed or protruding jaw

Medical History

The following factors may contribute to a potentially higher risk for airway difficulties. If any of these conditions are present, the clinician will determine the patient’s level of risk on an individual basis:
- Previous problems with anesthesia, sedation or airway management
- Stridor, snoring, or sleep apnea
- Advanced rheumatoid arthritis
- Abnormal anatomy in head/neck such as tumors
- Obese patients
- Congenital syndromes that involve the airway
- Radiation therapy or previous surgery to head/neck may distort airway and complicate airway manipulations
- Large beard such that mask ventilation is more difficult
- A short, thick, muscular neck

The ASA score is a subjective assessment of a patient’s overall health that is based on five classes (I to V). It is a risk index classification of the American Society of Anesthesiology (ASA).

I. Patient is a completely healthy fit patient.

II. Patient has mild systemic disease.

III. Patient has severe systemic disease that is not incapacitating.

IV. Patient has incapacitating disease that is a constant threat to life.

V. A moribund patient who is not expected to live 24 hour with or without surgery.

E. Emergency surgery, E is placed after the Roman numeral.

Patient Monitoring

Monitoring should be in place and clinicians should always be prepared to rescue patients who move to the next, deeper level of sedation.

Standard Monitoring

The standard monitoring parameters for sedated patients specified in the ASGE Guidelines for
Conscious Sedation and Monitoring during Gastrointestinal Endoscopy include measurement and recording of:

Oxygenation saturation
Heart rate
Respiratory frequency and ventilation
Blood pressure

Physiological Monitoring

Level of consciousness:
- Patient response to verbal commands and stimuli is a guide to the level of consciousness
  - Apatient under moderate sedation should be able to respond to verbal commands and light tactile stimuli.
- Scoring systems (see RASS and Ramsey examples) can help detect adverse drug responses so they can be treated in a timely manner, thus reducing risks for both moderate and deep sedation

Pulmonary ventilation

Drug-induced respiratory depression is the primary cause of morbidity associated with sedation and analgesia
The risk of adverse outcomes can be reduced by monitoring ventilatory function through:
- Observation or auscultation (including thoracic palpation, observation of abdominal/chest excursions and sensation of exhaled air)
Monitoring via capnography may reduce risks during moderate and deep sedation

Oxygenation

The risk of adverse events such as cardiac arrest and death can be decreased through the use of pulse oximetry with appropriate alarms for the early detection of hypoxia
Pulse oximetry has been shown to be more effective in detecting oxygen desaturation and hypoxemia during sedation/analgesia than clinical assessment alone

Hemodynamics

Regular monitoring of vital signs reduces the likelihood of adverse outcomes
Sedative and analgesic agents may interfere with the appropriate autonomic compensation for hypovolemia and procedure-related stressors
Inadequate sedation or analgesia, on the other hand, may result in patients developing dangerous autonomic stress responses such as tachycardia and hypertension
The risk of these complications may be reduced with early detection of changes in heart rate and blood pressure that lead to interventions to avert serious problems
Vital signs should be monitored every 3-5 minutes once a stable level of sedation has been established
Continuous electrocardiogram monitoring can be used to reduce risks during deep sedation and for high-risk patients (significant cardiovascular disease or dysrhythmias) during moderate sedation.
There is no clear opinion supporting the use of electrocardiography in normal-risk patients during moderate sedation

Capnography

Continuous analysis and recording of carbon dioxide (CO2) concentrations in respiratory gases throughout respiration
The measurement of end-tidal carbon dioxide (ETCO2) offers the clinician a useful adjunct to other monitoring methods in determining if hypercarbia is present
Capnography may be able to detect hypoventilation before pulse oximetry indicates oxygen desaturation
It has also been shown to be a more sensitive gauge of hypoventilation than visual observation.

Richmond Agitation and Sedation Scale (RASS)

+4	Combative	Violent, immediate danger to staff
+3	Very Agitated	Pulls or removes tube(s) or catheter(s); aggressive
+2	Agitated	Frequent non-purposeful movement, fights ventilator
+1	Restless	Anxious, apprehensive but movements not aggressive or vigorous
0	Alert & Calm
-1	Drowsy	Not fully alert, but has sustained awakening to voice (eye opening & contact ≥ 10 sec)
-2	Light Sedation	Briefly awakens to voice (eye opening & contact < 10 sec)
-3	Moderate Sedation	Movement or eye-opening to voice (but no eye contact)
-4	Deep Sedation	No response to voice, but movement or eye opening to physical stimulation
-5	Unarousable	No response to voice or physical stimulation
Source: Pain Management Nursing ©2009 W.B. Saunders

Ramsey Scoring System

Value	Description (level of sedation)	Test to follow
1	Awake: Patient is anxious and agitated, or restless, or both.	Observe the patient.
2	Awake: Patient is cooperative, oriented and tranquil.	Observe the patient. Does the patient make eye contact and respond to commands?
3	Awake: Patient responds to commands only.	Talk to the patient. Does the patient make eye contact and respond to commands?
	Asleep: Patient reacts with a brisk response to a light glabellar tap or a loud auditory stimulus.	Physically stimulate the patient by shaking the shoulder while speaking loudly. Does the patient respond within 10 seconds?
5	Asleep: Patient reacts with a sluggish response to a light glabellar tap or a loud auditory stimulus.	Physically stimulate the patient by shaking the shoulder while speaking loudly. Does the patient respond after 10 seconds?
6	Asleep: Patient does not respond to pain.	Use painful stimuli. No response.

Response during deep sedation will require more profound stimuli
A patient whose only response is reflex withdrawal from painful stimuli are deeply sedated, bordering on general anesthesia

Recovery & Discharge

The purpose of post-sedation monitoring is to ensure that the patient has returned to an acceptable level of functioning as described below before being discharged.
The time needed for recovery prior to discharge will vary depending on:
- Type and length of the procedure that was performed
- Types of sedation/analgesic agents used and the quantity administered
- The presence of procedural complications
- Age and physiologic condition of the patient
Consciousness level, hemodynamic parameters, oxygenation, and pain level should be measured at regular intervals until all values have returned to baseline. Vital signs should be documented every 5 minutes at the minimum.
Since the effects of naloxone and flumazenil are of shorter duration than those of the benzodiazepines and opioids they reverse, a more extended monitoring period (up to 2 hours) may be required if these reversal agents have been used.
A standardized score discharge scoring system such as the Aldrete Score should be employed to determine the patient’s recovery.

Modified Aldrete Scoring System

Activity

Able to move four extremeties voluntarily on comand

Able to move two extremeties voluntarily on command

Unable to move

Respiration

Able to deep breathe and cough freely

Dyspneic or limited breathing

Apneic

Circulation

BP and HR ± 20% of preanesthetic level

BP and HR ± 20% to 50% or preanesthetic level

BP and HR + 50% of preanesthetic level

Consciousness

Fully awake (able to answer questions)

Arousable on calling (arousable only to calling)

Unresponsive

Oxygenation

Able to maintain O₂ saturation > 92% on room air

Needs O₂ inhalation to maintain saturation > 90%

O₂ saturation < 90% even with O₂ supplement

A patient can be deemed suitable for discharge when the physiologic criteria are met and he or she is able to dress and walk independently
The patient does not need to be evaluated for tolerance of fluids or solids before being discharged home
Upon discharge, all patients need to receive verbal and written:
- Instructions outlining diet
- Activity
- Medication
- Follow-up recommendations
- A 24-hour contact number should be provided to the patient in the event of complications
The patient must be released only into the care of a responsible adult who can accompany him home

Risks & Complications

Cardiopulmonary complications (intra- and post-procedural)

Cardiopulmonary events related to sedation and analgesia is the most frequent cause of GI endoscopy-related morbidity/mortality. These complications range in severity from transient, minor oxygen desaturation, to life threatening events such as apnea, shock/hypotension and myocardial infarction.

Elderly (older than age 65)
Comorbidities
- Preexisting cardiopulmonary disease
- Morbidly obese
- Uncontrolled Diabetes (Pre-procedure glucoses <80 or >300)
Potential Perioperative Risks: ASA 3 or greater – consider anesthesia assistance

Difficult airways	Sleep apnea; obesity; short neck; reduced mouth opening; large tongue Mallampati score of 3 or 4; anatomical abnormalities
Risks of aspiration	Acute upper gastrointestinal bleeding; gastric outlet obstruction; delayed gastric emptying; achalasia
Reuced tolerance / paradoxical reactions to standard sedatives	Tobacco, alcohol, or substance abuse; previous adverse experience with sedation; neuropsychiatric disorder; allergies; drug interactions

Respiratory depression
Cardiac complications
Paradoxical reactions – i.e. excessive talkativeness, movement and emotional release. Precipitated by benzodiazepines. Predisposing patient characteristics for paradoxical reaction:
- Young and advanced age
- Genetic predisposition
- Alcoholism or drug abuse
- Psychiatric and/or personality disorders
- Methemoglobinemia – precipitated by topical anesthesia

Sedation Guidelines and Policies

The appropriate guidelines and policies governing sedation at the hospital or ambulatory surgical facility where it is performed should be maintained at all times. The American Society of Anesthesiologists Guidelines for Ambulatory Anesthesia and Surgery specifies that at minimum:

A licensed physician should be in attendance in the facility at all times during patient treatment, recovery, and discharge
The facility must be established, equipped, constructed, and operated in accordance with applicable federal, state, and local laws
Staff in attendance should be adequate to meet patient and facility needs and must consist of:
- Professional staff including physicians, nurses, and other practitioners who are duly licensed and qualified
- Administration staff
- Housekeeping and maintenance staff

The physicians who provide medical care in the facility should be organized into a medical staff. This group will assume responsibility for credential review, delineation of privileges and responsibilities, quality assurance and peer review. There must be adequate personnel and equipment available to manage emergencies. The facility must have established policies and procedures to handle unanticipated patient transfer to an acute care hospital.

According to the American Society of Anesthesiologists Guidelines for Ambulatory Anesthesia and Surgery, patient care shall include:

Preoperative instructions and patient preparation
An appropriate history and physical exam by a physician prior to sedation
Preprocedure studies as outlined in the American Society for Gastrointestinal Endoscopy Position Statement on Laboratory Testing Before Ambulatory Elective Endoscopic Procedures
Procedural sedation shall be administered by or under the direction of a qualified physician
General anesthesia shall be administered by the appropriate anesthesiology personnel
The physician is responsible for directing discharge criteria
Patients must be provided with written postoperative and follow-up instructions
Medical records must be accurate, confidential and current

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