In July 2003, The Joint Commission Board of Commissioners approved the Universal Protocol for Preventing Wrong Site, Wrong Procedure and Wrong Person Surgery™. The Universal Protocol was created to address the continuing occurrence of these tragic medical errors in Joint Commission accredited organizations. The Universal Protocol became effective July 1, 2004 for all accredited hospitals, ambulatory care and office-based surgery facilities. The Universal Protocol drew upon, and expanded and integrated, a series of requirements under The Joint Commission’s 2003 and 2004 National Patient Safety Goals. It is applicable to all operative and other invasive procedures. The principal components of the Universal Protocol include: 1) the pre-operative verification process; 2) marking of the operative site; 3) taking a ‘time out’ immediately before starting the procedure; and 4) adaptation of the requirements to non-operating room settings, including bedside procedures. The protocol is endorsed by 51 professional health care associations and organizations (see below).
Wrong site, wrong procedure and wrong person surgeries are sentinel events (an unexpected occurrence involving death or serious physical or psychological injury) that are tracked through The Joint Commission sentinel event database. The Joint Commission has issued two Sentinel Event Alert newsletters on the subject of wrong site surgery; the first was published August 28, 1998, and the follow-up issue was published December 5, 2001. In response to continuing reports of wrong site, wrong procedure and wrong person surgery, Joint Commission leadership agreed that it was necessary to get key organizations involved in efforts to prevent wrong site, wrong procedure and wrong person surgery.
Development of the Universal Protocol
On May 9, 2003, The Joint Commission hosted a Wrong Site Surgery Summit, with the goal of obtaining consensus on the adoption of a “universal protocol” for preventing wrong site, wrong procedure and wrong person surgery. The Summit was hosted by The Joint Commission in collaboration with: American Medical Association, American Hospital Association, American College of Physicians, American College of Surgeons, American Dental Association, and American Academy of Orthopedic Surgeons. The leaders of more than 30 other professional groups participated in the Summit. Summit participants agreed that a universal protocol would help prevent the occurrence of wrong site, wrong procedure and wrong person surgery; that the protocol should be specific, so as to eliminate confusion about site marking and facilitate communication among surgical team members; and that it should provide the flexibility needed for unique surgical situations.
The Joint Commission pursued broad consensus on the draft of the Universal Protocol in order to make it valuable and useful to the majority of surgical situations and staff. The public comment period generated more than 3,000 responses from surgeons, nurses and other health care professionals, which were overwhelmingly in support of the Universal Protocol. The comments also provided the basis for a number of refinements to the Protocol. The final Universal Protocol and its Implementation Guidelines are available at http://www.jointcommission.org/Patient Safety/UniversalProtocol. Following approval by the Board, The Joint Commission sought endorsement of the Universal Protocol from leading professional associations and organizations. Approximately 51 professional associations and organizations have endorsed the Universal Protocol (see list below).
A follow-up Summit focuses on refinements
Wrong site, wrong procedure and wrong person surgeries are sentinel events that persist as a problem at the rate of five to eight new cases each month and recently became the most frequently reported sentinel event in The Joint Commission’s Sentinel Event database. On February 23, 2007, The Joint Commission convened a second Wrong Site Surgery Summit to address the concerns raised by a number of professional organizations and a continued increase in the occurrences of reported wrong site surgery cases to The Joint Commission. Overall, participants agreed that the current Universal Protocol is effective if properly implemented and consistently followed. Consensus was also achieved on a number of important points, including:
- Further refinements to, and elaboration of, the Universal Protocol will likely be required to make the protocol consistently successful across all health care organizations.
- There should be “zero tolerance” for failure to follow the Universal Protocol as a short-term goal, and that the long-term goal should be zero tolerance for occurrence of these events.
- Explicitly state that the Universal Protocol applies to all types of procedures in all types of procedure areas. These include the administration of regional anesthetics and radiologic interventions.
Currently, The Joint Commission is continuing with the follow-up activity based on input from this second Summit. Any potential future revisions to the current Universal Protocol would be vetted externally and would require approval from The Joint Commission governance committees and The Joint Commission’s Board of Commissioners prior to any revisions being released.
The original Universal Protocol remains unchanged at this time.
Endorsers of the Universal Protocol
Accreditation Council for Graduate Medical Education
Agency for Healthcare Research & Quality
American Academy of Ambulatory Care Nursing
American Academy of Cosmetic Surgery
American Academy of Facial Plastic and Reconstructive Surgery
American Academy of Family Physicians
American Academy of Ophthalmology
American Academy of Orthopedic Surgeons
American Academy of Otolaryngology-Head & Neck Surgery
American Academy of Pediatrics
American Association of Ambulatory Surgery Centers
American Association of Eye & Ear Hospitals
American Association of Neurological Surgeons
American Association of Nurse Anesthetists
American Association of Oral & Maxillofacial Surgeons
American College of Cardiology
American College of Chest Physicians
American College of Emergency Physicians
American College of Foot and Ankle Surgeons
American College of Obstetricians & Gynecologists
American College of Physicians
American College of Radiology
American College of Surgeons
American Dental Association
American Hospital Association
American Medical Association
American Medical Group Association
American Nurses Association
American Organization of Nurse Executives
American Pediatric Surgical Association
American Radiological Nurses Association
American Society for Surgery of the Hand
American Society of Anesthesiologists
American Society of General Surgeons
American Society of Ophthalmic Registered Nurses
American Society of PeriAnesthesia Nurses
American Society of Plastic Surgeons
American Society of Plastic Surgical Nurses
American Urological Association
Association of American Medical Colleges
Association of periOperative Registered Nurses
Association of Surgical Technologists
Congress of Neurological Surgeons
Federated Ambulatory Surgery Association
Federation of American Hospitals
Medical Group Management Association
National Association Medical Staff Services
National Patient Safety Foundation
North American Spine Society
Radiological Society of North America
Society of Thoracic Surgeons
For more information, contact the Standards Interpretation Group at (630) 792-5900, or submit your question at http://www.jointcommission.org/Standards/OnlineQuestionForm.
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