Policies and Guidelines
General Guidelines for Office Procedures Where Procedural Sedation is Required
Note re. Guidelines and Policies
This document is a physician guideline approved by the Council of the College of Physicians and Surgeons of Nova Scotia.
Guidelines contain recommendations endorsed by the College of Physicians and Surgeons of Nova Scotia. The College encourages its members to be familiar with and to follow its guidelines whenever possible and appropriate. Note that guidelines may contain references to College policies.
Policies reflect the position of the College of Physicians and Surgeons of Nova Scotia. Physicians licensed with the College are expected to be familiar with and to comply with College policies.
Acknowledgments
The College consulted with the following organizations in the preparation of these guidelines:
Canadian Anesthesiologists' Society
Section Of Surgery, Doctors Nova Scotia
Section Of Anaesthesiology, Doctors Nova Scotia
Canadian Association of General Surgeons
Department of Emergency Medicine, Dalhousie University
Department Of Surgery, Dalhousie University
Department Of Anesthesia, Dalhousie University
Queen Elizabeth II Health Sciences Centre TPU
Preamble
It is anticipated that because of changes in health care delivery the demand for office procedures which utilize sedation will increase in the future. The College of Physicians and Surgeons of Nova Scotia has the legislative mandate "to establish, maintain and develop standards of knowledge and skill amongst its members" and "standards of qualification and practice for the practice of medicine
in order that the public interest may be served and protected." The College has been asked by physicians to endorse guidelines for non-hospital based procedures which require sedation. As a result of this request and because there is a general need for such guidelines, the College's Council has decided to produce generic guidelines for office-based procedures where sedation is utilized. It is anticipated that this template will be used to ensure that office-based procedures which utilize sedation are carried out safely.
These general guidelines are intended to be broad in scope and general in their application. For greater clarity, physicians are referred to Appendix 3: ASA Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologists.
Definitions
Anxiolysis (Minimal Sedation) is a drug-induced state during which patients respond normally to verbal commands. Although cognitive function and coordination may be impaired, ventilatory and cardiovascular functions are unaffected.
Procedural Sedation (Moderate Sedation/Analgesia) is a deeper level of sedation/analgesia than anxiolysis (Minimal Sedation). It (Moderate Sedation/Analgesia) is defined as a drug-induced depression of consciousness during which patients respond purposefully (reflex withdrawal from a painful stimulus is not considered a purposeful response) to verbal commands, either alone or accompanied by light tactile stimulation. The medically controlled state of depressed consciousness:
allows protective reflexes to be maintained:
retains the patient's ability to maintain a patent airway independently and continuously;
The goals of procedural sedation are to:
facilitate the performance of a procedure;
control behaviour, including anxiety; and
return the patient to a state in which safe discharge is possible.
Candidates for Procedural Sedation in the Office Setting
Only those who are considered ASA PS 1 or ASA PS 2 should be candidates for office procedures using procedural sedation. (See Appendix 1: American Society of Anesthesiology Physical Status (PS) Classification System). Special care and consideration must be taken into account for pediatric patients and those over 65 years.
ASA PS 1
Normal healthy patients
No organic, physiologic, or psychiatric disturbance; excludes the very young and very old; healthy with good exercise tolerance
ASA PS 2
Patients with mild systemic disease
No functional limitations; has a well-controlled disease of one body system; controlled hypertension or diabetes without systemic effects, cigarette smoking without chronic obstructive pulmonary disease (COPD); mild obesity, pregnancy.
Patients undergoing procedural sedation should not eat solids or drink liquids for a period of time that is sufficient to allow for gastric emptying prior to the procedure. For further information, see Appendix 2: Fasting and Emergency Department Procedural Sedation and Analgesia: A Consensus-Based Clinical Practice Advisory from the American College of Emergency Physicians.
Physician Qualifications and Experience
Office-based procedures and procedural sedation should only be performed by physicians who have been adequately trained in these procedures and in airway and ventilatory support management. The same standards of training and experience are expected of these physicians as would generally qualify them for privileges in a Nova Scotia hospital. At the least, there should be a statement from a qualified physician mentor at the completion of training which states explicitly the procedures in which the physician is competent.
Whenever propofol is used for sedation/anesthesia, it should be administered only by persons trained in the administration of general anesthesia, and who are not simultaneously involved in these surgical or diagnostic procedures. Further information is available in Appendix 4, AANA-ASA Joint Statement Regarding Propofol Administration. Similar concerns apply when other intravenous induction agents are used for sedation, such as thiopental, methohexital or etomidate.
Non-Physician Office Staff Qualifications and Experience
The duties and responsibilities of the non-physician office staff assisting with sedation should be in accordance with their training, education and experience and should be under the direct supervision of the medical practitioner. These staff should not be assigned duties or responsibilities that require medical licensure.
There should be a designated person, other than the practitioner who performs the procedure, present to monitor the patient throughout the procedure performed under procedural sedation. This person may assist with minor, interruptible tasks.
Facilities and Equipment
Facilities
There should be an adequate space for interviewing patients and a space for doing the procedure that is large enough to contain the necessary procedural and resuscitation equipment, if needed. This space should also be large enough to permit easy access to the patient in an emergency and should be readily accessible by emergency personnel if the need arises.
The recovery space should be adequate for the patient to rest following the procedure and should allow the patient to lie down if necessary, rather than sitting in a waiting room. The recovery area should be monitored under the supervision of an appropriately trained and certified person. This person cannot simultaneously assist during procedures.
Equipment
The procedure should not be compromised because of lack of equipment required for the proposed procedure. Guard-rails, wide procedure tables and restraining straps should be used, if necessary, to prevent falls and mechanical injuries during procedures. Protective clothing and equipment for staff and patients should be used as needed and there should be emergency backup power sufficient to ensure patient protection.
Automated blood pressure and cardiac monitoring should be available. Pulse oximetry should be used during and after the procedure until the patient has recovered. Adequate cardiac and respiratory resuscitation equipment should be readily available and should include oxygen, bag/mask ventilator, oral and nasopharyngeal airways, appropriate drugs and suction. If hypoxemia is anticipated or occurs during procedural sedation, supplemental oxygen should be given. Drugs to reverse benzodiazepine and opioid induced sedation should be available.
Where the patient receives sedation by the intravenous route, vascular access should be maintained until the patient is no longer at risk of cardio-pulmonary depression. Where procedural sedation is given by non-intravenous routes, or where the intravenous line becomes dislodged or blocked, it should be determined on a case-by-case basis whether to establish or re-establish intravenous access. In all cases, a person with the skills to establish intravenous access should be immediately available.
Maintenance of equipment
All equipment used in the procedure (including monitoring and emergency equipment) should have periodic preventive maintenance and testing by a qualified person.
Disinfection and infection prevention
There should be standard protocols for protection of both patients and staff from infectious diseases, for example, body fluid isolation, proper specimen handling and proper instrument cleaning and disinfection. All staff should be trained in infection control practices and the implementation of universal precautions. Where disinfection is carried out using chemicals (e.g. glutaraldehyde) there should be adequate venting to the outside of the building. There should never be recirculation in a closed building system. Adequate measures should be in place to prevent injury to staff using chemicals.
Documentation
Records must be maintained on site and available for review. The records should contain a brief history and physical examination by a physician. Cardiopulmonary or other diseases should be excluded by appropriate evaluation. There should be documentation of the indications for the procedure and an informed consent documented-in the case of minors the consent of the parent or legal guardian. Compliance with dietary precautions consistent with accepted norms of anesthesia should be documented. A description of the procedure and the findings should be documented, as well as the status on discharge and plans for follow-up care.
Vital signs, including heart rate, respiratory rate, blood pressure and oxygen saturation, throughout the procedure should be documented, as well as any medication used and its route of administration.
Discharge and patient information
Patients should be sufficiently recovered from the procedure and sedation before discharge, and on discharge should be accompanied by a reasonable adult. Patients should be given written instructions regarding:
the procedure performed
common complications that may arise
telephone numbers to be used by the patient should complications or questions arise
instructions for medications prescribed, if any
date, time and location of follow-up return appointment
designated place to go for treatment in event of an emergency
Caution should also be given about continued functional impairment for many hours following procedural sedation. For example, patients should not drive home on discharge. In the case of children, parents should be warned about this functional impairment with regard to such motor skills as bicycle riding and climbing stairs.
Emergency Care and Transfer Plan
As the need for emergency care may arise at any time during a procedure utilizing procedural sedation, emergency transport to an acute care facility that is willing to accept patients from the office should be guaranteed. There should be a plan for the provision of emergency care in the office and for the timely transfer of the patient to a nearby emergency care facility. There should be appropriate training and equipment for the care of children if they are to be patients. All staff should be trained in emergency care and cardiopulmonary resuscitation, and should be familiar with the plan and procedures to be followed in an emergency and be able to take any action as needed. At least one member of the team should have an up-to-date Advanced Cardiovascular Life Support (ACLS) certificate. The emergency and transfer plan and procedure should be documented.
Continuous Quality Improvement (CQI) Program
All facilities should participate in a continuous quality improvement program and should be subject to periodic reviews and audits. The following would be acceptable for such a program:
an internal CQI program
a cooperative agreement with a hospital CQI program
a cooperative agreement with another practice to jointly conduct a CQI program
a cooperative agreement with a peer review organization, specialty society or other like organization
CQI programs should include (but not be limited to):
review of mortalities
review of complications, including postoperative infections
review of direct patient transfers to an acute care facility
review of complaints and patient satisfaction surveys
There should be a job description for all staff and their performance should be continually assessed and improved where necessary.
Appendix 1: American Society of Anesthesiology Physical Status (PS) Classification System
ASA PS 1
Normal healthy patients
No organic, physiologic, or psychiatric disturbance; excludes the very young and very old; healthy with good exercise tolerance
ASA PS 2
Patients with mild systemic disease
No functional limitations; has a well-controlled disease of one body system; controlled hypertension or diabetes without systemic effects, cigarette smoking without chronic obstructive pulmonary disease (COPD); mild obesity, pregnancy
ASA PS 3
Patients with severe systemic disease
Some functional limitation; has a controlled disease of more than one body system or one major system; no immediate danger of death; controlled congestive heart failure (CHF), stable angina, old heart attack, poorly controlled hypertension, morbid obesity, chronic renal failure; bronchospastic disease with intermittent symptoms
ASA PS 4
Patients with severe systemic disease that is a constant threat to life
Has at least one severe disease that is poorly controlled or at end stage; possible risk of death; unstable angina, symptomatic COPD, symptomatic CHF, hepatorenal failure
ASA PS 5
Moribund patients who are not expected to survive without the operation
Not expected to survive > 24 hours without surgery; imminent risk of death; multiorgan failure, sepsis syndrome with hemodynamic instability, hypothermia, poorly controlled coagulopathy
ASA PS 6
A declared brain-dead patient whose organs are being removed for donor purposes
Appendix 2: Fasting and Emergency Department Procedural Sedation and Analgesia: A Consensus-Based Clinical Practice Advisory from the American College of Emergency Physicians
© 2006 by the American College of Emergency Physicians.
http://www.acep.org/NR/rdonlyres/6FF6A276-E14E-4C00-B9C7-083FDDDDDE3E/0/cpSedAnalg2Feb05.pdf
Appendix 3: ASA Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologists
Further information about office-based procedural sedation is contained in the following document on the website of the American Society of Anesthesiologists:
http://www.asahq.org/publicationsAndServices/sedation1017.pdf
Appendix 4: AANA-ASA Joint Statement Regarding Propofol Administration
The College of Physicians and Surgeons of Nova Scotia and the Canadian Anesthesiologists' Society encourage physicians to be aware of the following joint statement regarding Propofol administration from the American Society of Anesthesiologists and the American Association of Nurse Anesthetists:
http://www.asahq.org/news/propofolstatement.htm
Document Approval and History
Approved by Council: March 9, 2007
Replaces General Guidelines for Office Procedures Where Conscious Sedation is Required, approved by Council
March 23, 2001
