Universal Protocol in Interventional Radiology
Rathachai Kaewlai
Hani H. Abujudeh
Wrong site, wrong procedure, and wrong patient (WSWPWP) interventions result in devastating injuries to the patient. They are generally rare (1 in 50,000 to 100,000 procedures) but more prevalent in procedures associated with laterality (1,2) and probably occur equally in nonsurgical interventions and surgical disciplines (3). Medical errors attract negative media attention, undermine public confidence in the health care system, and devalue and demoralize physicians. These preventable errors are frequently caused by a failure in communication and poor operating physician leadership (4). Organizational culture and steep hierarchical structures in the procedure room also play a role (2,5). To prevent such errors and improve patient safety, The Joint Commission (JC; effective 2004) requires the establishment of a Universal Protocol at all hospitals, ambulatory care, and office-based surgery facilities seeking accreditation. In 2008, the Society of Interventional Radiology (SIR) published supplemental guidelines for fulfilling this requirement (6). The JC’s latest revision of the Universal Protocol was effective January 1, 2010 (7). However, even in the Universal Protocol era, prevalence of WSWPWP is still significant and unacceptable. Multifaceted strategy (Universal Protocol, WHO surgical safety checklist, medical team training) is required to eliminate these errors (8).
Universal Protocol
1. The Universal Protocol, a three-step process, includes multiple strategies to prevent WSWPWP errors:
a. Preprocedure verification
b. Site marking
c. Time-out
2. Each step in the Universal Protocol is complementary to the other and is intended to introduce redundancy to the practice of confirming the correct site, procedure, and patient (5).
3. Any step used alone is unlikely to reduce the incidence of WSWPWP errors (5).
Indications
All surgical and nonsurgical invasive procedures that expose patients to more than minimal risk must have an indication (9).
1. JC defines “invasive procedures” as those involving “the puncture or incision of the skin, insertion of an instrument, or insertion of foreign material into the body. Invasive procedures may be performed for diagnostic or treatment-related purposes.”
2. Common procedures such as peripherally inserted central catheters (PICC) line insertion, as well as all central line and chest tube insertions, must fulfill the Universal Protocol requirement.
Exemptions to Universal Protocol
a. Puncture of small peripheral veins
b. Peripheral intravenous line placement
c. Insertion of a nasogastric tube or urinary bladder catheter
d. Lithotripsy
e. Performance of dialysis (does not include insertion of dialysis catheter)
f. Minor procedure, posing minimal patient risk, whose need is discovered during a routine clinic visit, for example, drainage of a newly discovered seroma/cyst
2. Patient-related
a. Profoundly medically unstable patient
b. Patient in cardiopulmonary arrest
Preprocedure Verification
1. Essentials
a. The purposes of preprocedure verification are to ensure (a) availability of all relevant documents, information, and equipment prior to the start of the procedure; (b) understanding of the patient about the procedure to be performed; and (c) correct identification of the patient and procedure to be performed by all members of the operating or procedure area.
b. Confirmation of correct site, procedure, and patient is made at every stage from the time of decision to perform the procedure to the time the patient undergoes the procedure. The verification may occur at more than one time and place before the procedure is performed.
c. Verification should be performed with patient involvement, being awake and aware of the process, as much as possible.
d. A standardized list can be used in the verification process. The list helps verify that all information, relevant documents, and necessary equipment are:
(1) Available prior to the start of the procedure
(2) Correctly identified, labeled, and matched to the patient’s identifiers
(3) Reviewed and consistent with the patient’s expectations and with the team’s understanding of the intended patient, procedure, and site
2. When
a. At the time the procedure is scheduled
b. At the time of preadmission testing and assessment
c. At the time of admission or entry to the facility for the procedure, whether elective or emergent
d. Before the patient leaves the preprocedural area or enters the procedure room
e. At any time, responsibility for care is transferred to any other member of the care team.
3. How
a. Patient identification (hospital wristband), proper labeling of patientrelated items, and cross-confirmation by checking patient records, including imaging studies. This is done using a standardized list (previously called “checklist”).
