In 2003, the Joint Commission implemented a Universal Protocol to prevent wrong site surgeries.1 Since that time, this Protocol has evolved numerous times to not only include prevention of wrong site surgeries, but also to prevent the wrong procedure on the wrong person. The Joint Commission’s 2016 National Patient Safety Goals for hospitals address prevention of surgical mistakes in UP.01.01.01 (applicable to the pre-procedure verification process), UP.01.02.01 (marking the procedure site), and UP.01.03.01 (describes the timeout that is performed before the procedure). The Universal Protocol is applicable and required for those procedures that place a patient at risk, including procedures that are invasive in nature and involve anesthesia or deep sedation.2
At our facility, the title “Safe Procedure Review” is synonymous with the Universal Protocol. Physicians and colleagues in our department understood that this process was a requirement, so rather than just going through the motions, we agreed that as long as we were required to do it, we would make it meaningful and worthwhile. We didn’t just want automatic behaviors from the team — we wanted active participation and communication that would improve the safety of our patients as well as reduce errors. The review is completed multiple times during the immediate pre-, intra-, and post-operative period, and all members of the team participate.
Nursing colleagues start the review in the holding area upon the patient’s arrival. Here we identify the patient using two identifiers, most often name and birthdate. The procedure to be done is confirmed with the patient. Pre-procedure lab and x-ray results are reviewed, NPO status is verified, and allergies are identified. If allergies are noted, especially to contrast materials or antibiotics, orders can be obtained for the appropriate medication regimen. It is important that both the patient and family are actively involved in the process. Not only are we validating information for the upcoming procedure, but we are reviewing and confirming the patient’s understanding of what will be happening to them during that procedure. Education and clarification of expectations can be done if discrepancies are noted.
Holding area colleagues also confirm that there is a history and physical present on the chart. This document can be done up to 30 days prior to the procedure, but must contain an addendum describing an updated assessment of the patient performed on the day of the procedure. When there are no changes to the patient assessment and condition, an example of accepted standard verbiage is “patient examined and assessment unchanged.” This must be signed, dated, and timed by the physician to be considered valid.
Presence of a signed consent is also verified during this pre-procedure period. Informed consent must be obtained by the physician. This must include the procedure to be done as well as an explanation of the risks and benefits. In our facility, this document can also include a consent for blood products. Signatures must be obtained from the patient or patient representative, a witness, and the physician performing the procedure. Again, date and time are an absolute must on this document. We work with our colleagues to recognize that all “blanks” must be filled in on the consent for it to be valid. In order to maintain efficiency and patient flow, we are working with the clinics so that the consent can be obtained during the office visit where the procedure is discussed. This is an ideal time for the informed consent process as the physician and patient are face to face, and all pertinent discussions can take place and signatures can then be obtained. This consent is then scanned into the electronic medical record so that it is available the day of the procedure. Holding area personnel verify the patient’s signature and understanding, and confirm that consent has been given for the planned procedure.
The last step in the process for the holding area is to confirm that the appropriate equipment, devices, implants, and/or industry representatives are scheduled for the upcoming procedure. Because of the nature of our procedures in the EP lab, we are exempt from site marking as there are no laterality issues. This is outlined in the general hospital policy for the Universal Protocol.
The next phase of the review begins when the anesthesiologist arrives in the holding area to assess the patient. In addition to repeated verification of information described above, assessment of the airway is done. If there is noted to be a difficult airway or aspiration risk, measures are taken at this point to alleviate those issues. Additional medication may be given or a GlideScope (Verathon, Inc.) is obtained for the intubation process. Risk of blood loss is assessed and special medications are ordered based on the patient assessment. Measures for normothermia are discussed, such as use of Bair Hugger therapy (3M) and appropriate temperature settings for the patient. During this phase, a discussion is also held between the proceduralist and the anesthesiologist to determine the level of sedation required for the specific procedure — whether general anesthesia is needed at the onset of the procedure, or just light sedation until arrhythmic testing can be completed. The anesthesiologist then performs designated safety checks of the equipment and for the presence of the appropriate medications. Confirmation of all information is noted between the anesthesiologist and the nurse caring for the patient.
The third timeout occurs in the procedure room after the patient has been prepped and immediately before the incision or stick is made. The RN in the control room initiates the timeout, but we have found that when this part of the review is made conversational, all members of the team participate. It is required that everyone stop what they are doing and pay attention to the information given. Everyone in the room is introduced so that everyone knows who is “behind the mask,” especially industry representatives that are not familiar with the usual members of the team. Again, the patient and procedure are identified. Allergies are reviewed. The physician confirms the procedure. The circulator reports information such as potassium levels, last dose of blood thinner or antiarrhythmic medications, or other pertinent information. The scrub person verifies that appropriate sterilization indicators are present on both the equipment and the supplies to be utilized. The anesthesiologist reports time of administration of the antibiotic, the sedation plan, or confirmed placement of an esophageal probe when appropriate. The industry representative confirms that the appropriate devices and/or leads, catheters, or sheaths are available. Any critical steps in the procedure are discussed. If a device is to be implanted, a fire risk assessment is done and a discussion is held on what to do in case of a fire.
For clarification, the fire risk assessment3 is utilized when a procedure site or incision is above the xiphoid, when there is an open oxygen source such as a face mask, cannula, LMA, or ET tube and an ignition source such as unipolar cautery. A score from 1 to 3 will be assessed based on the above, with 1 being low risk and 3 being high risk.
If a risk is identified, the following will be implemented:
- A minimum of 3 minutes of drying time will be utilized with alcohol-based prep materials. A minimal amount of solution is to be used, and the patient is not to be draped until the prep is fully dried. No pooling of prep solution under the patient should be allowed and all prep solutions should be removed from the sterile field as soon as possible. (For identified risk of 1-2)
- All equipment should be checked prior to the case. Cautery should be stored in the holster when not in use. Activation and de-activation of the heat source must be timed appropriately by the physician. (For identified risk of 1-2)
- A CO2 fire extinguisher must be readily available either inside the procedure room or just outside. (For identified risk of 1-2)
- Wet sponges and a basin of sterile water or saline must be available on the field for fire suppression. (For identified risk of 3)
- Conversations must be had between the physician and anesthesiologist concerning use of cautery so that oxygen administration can be handled appropriately. (For identified risk of 3)
After all components of the safe procedure are reviewed, the final commentary is made by the physician. The team is asked if they have any concerns that have not been discussed, and they are encouraged to speak up if they see something that concerns them during the case. The team has been empowered to question the situation if something is concerning; examples of this include asking about blood pressure and the administration of medications, lead or catheter placement, increased fluoroscopy time, or decreased urinary output.
Lastly, the final phase of the review is done after the procedure is completed and before the physician leaves the room. The physician confirms that the procedures were performed. At this time, sharp and sponge counts are reviewed, and specimens are accounted for (if any). The physician then discusses any equipment problems or issues noted during the case. Of most importance, the key concerns for patient management in the post-operative period are reviewed.
The Joint Commission does not require that all elements of the Protocol be documented in the patient record. It is left up to the facility to determine the amount and type of documentation needed. In some facilities, a simple phrase such as “timeout procedure completed successfully” can be documented to meet the standards.
In our department, we felt that we could ensure appropriate utilization of the review by including the appropriate forms in our hemodynamic monitoring system. All elements were incorporated into easy-to-use forms with drop-down options and macros. These included the Safe Procedure Review in the holding area, and Pre-induction, Procedural, and Post-procedural assessments. A separate form was built for the Surgical Site Fire Risk Assessment. When utilized appropriately, all elements are present in the final report of the procedure.
In order to ensure that all elements are discussed, visuals are also encouraged. This can be as simple as a laminated checklist that is utilized in every case (Figure 1). In our facility, large posters outlining the process were hung on the walls in all procedural areas for reference (Figure 2). These have been placed close to the procedure table so that all team members can readily see it. The poster is a great tool that outlines all the components that must be addressed, and has been used frequently by medical staff and colleagues.
Elements of Performance
During a Joint Commission survey, there will be certain elements of performance related to the Universal Protocol that will be assessed.4 For UP.01.01.01, surveyors will review the process in place to verify the correct procedure, patient, and site. They will evaluate the presence of relevant documentation such as the history and physical, informed consent, and assessments by nursing and anesthesia. They will check appropriate labeling of specimens or test results, and check to see if all needed equipment and implants were available. At this point, the surveyor will look for consistency in the pre-procedure verification and if it is done in a repetitive manner.
For UP.01.03.01, standardization and consistency are again key. Surveyors will want to see that all members of the team are communicating during this segment, and that the procedure is not started until all issues are resolved. Standard flow of the Protocol review will be assessed. Agreement on the correct patient site and procedure must be achieved. Documentation of the completed process will be evaluated.
I know that the subject of the Universal Protocol can be a very unpopular subject on days when the schedule is very heavy, when the department is understaffed, or when physicians are pushing to complete more procedures in a shorter amount of time. However, these are the times that the Protocol is needed the most and must be taken seriously. As caregivers, we need to step back and review what we are doing, as the mistakes that we may potentially make can have a devastating impact on the lives of the patients we care for. We need to anticipate and detect problems early, so we can prevent harm to our patients. The foundation of the Universal Protocol assists us in this task. Reasons for completing the Protocol should not be because the Joint Commission tells us to — it should be because we want to make procedures safer for patients.
Disclosure: The author has no conflicts of interest to report regarding the content herein.
- Feldman DL. The Inside of a Time Out. AHRQ Patient Safety Network. Published May 2008. Available online at https://psnet.ahrq.gov/webmm/case/177/the-inside-of-a-time-out. Accessed September 23, 2016.
- Hospital: 2016 National Patient Safety Goals. The Joint Commission. Published November 5, 2015. Available online at https://www.jointcommission.org/hap_2016_npsgs/. Accessed September 23, 2016.
- Universal Protocol and Fire Risk Assessment. Christiana Care Health Services. Available online at https://www.christianacare.org/documents/firesafety/Universal%20Protocol-Fire%20Risk%20Assessment%20%20Bedside%20Procedure%20-%20firesafety.pdf. Accessed September 23, 2016.
- National Patient Safety Goals. Elements of Performance. The Joint Commission. Available online at http://www.jointcommission.org/assets/1/6/2016_NPSG_HAP.pdf. Accessed September 23, 2016.