Applicability and compliance FAQs
- Is the "Universal Protocol" a requirement or just advice to be considered?
- In the Guidelines for Implementing the Universal Protocol, the word "must" is used in some places and "should" is used in others? Is that intentional? What is the difference?
- How does the Universal Protocol relate to the NPSGs that currently address wrong site surgery?
- Are there any differences between the NPSG requirements and the Protocol requirements?
- What procedures fall within the scope of the Universal Protocol?
Preop verification FAQs
- Isn't this preoperative checklist thing just another onerous Joint Commission documentation requirement?
Site Marking FAQs
- Does the site need to be marked for all procedures or is it just for right/left procedures?
- In the FAQs for the NPSGs, there was a site-marking exemption for procedures done through a natural body orifice. Does that still apply? What if the incision/insertion site is midline but the organ to be operated on is right or left?
- What about dental procedures? I understand there have been several cases of extraction of the wrong teeth.
- Does the site have to be marked if there is an obvious wound or lesion?
- Is marking of the site necessary for bedside procedures such as chest tube insertion?
- Some of these cases may be done as emergency procedures. What then?
- Who should mark the site?
- When should the site be marked?
- What if the patient cannot participate in the marking process?
- What if the patient refuses site marking?
- How should the site be marked (an "X," the word "Yes," the surgeon's initials)?
- What happens to the site marked when a patient requires multiple surgeries during their hospital stay? [Added 5/24/04]
For "right/left" cases, is it acceptable to mark the opposite site with a "NO" rather than marking the intended operative site? [Updated 5/5/04]
- Do you need to mark the site for laparoscopic procedures? [Added 5/5/04]
- What is the recommended procedure for marking spinal surgery cases?
- Our surgeons are concerned about an increased risk of wound infection from marking the surgical site. Is this a valid concern?
What kind of marker or pen should be used to mark the site? [Added 5/5/04]
- Are adhesive site markers permitted under the Protocol?
- If site marking is not required for particular procedure, are the other provisions of the Protocol still required?
- What specific surgical procedures require marking of the site? [Added 12/16/04]
Time Out FAQs
- When should the "time out" occur?
- Who should participate in the "time out" process?
- What is meant by "active communication" as part of the "time out" process?
- What if there is only one person involved in doing the procedure?Is a time out still expected? Should someone else be brought in to do the time out?
Applicability and compliance FAQs
Is the "Universal Protocol" a requirement or just advice to be considered?
Effective July 1, 2004, compliance with the Universal Protocol For Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery will be required of all Joint Commission accredited organizations, to the extent that these requirements are relevant to the services provided by the organization.
In the Guidelines for Implementing the Universal Protocol, the word "must" is used in some places and "should" is used in others? Is that intentional? What is the difference?
The use of "must" and "should" is intended to distinguish between requirements (those steps that must be done as stated in the Guidelines) and preferred approaches that should be done as stated whenever possible but that allow some degree of flexibility to accommodate the unique characteristics of a particular organization. For example, refer to the FAQ (later in this document) on who should mark the surgical site.
How does the Universal Protocol relate to the NPSGs that currently address wrong site surgery?
The 2004 NPSGs include three requirements that relate directly to wrong site surgery (1b, 4a, and 4b). These three NPSGs requirements will remain in effect—that is, will be surveyed and scored—until the Universal Protocol is officially implemented as an accreditation requirement on July 1, 2004. At that time, survey of compliance with these separate requirements of the NPSGs will be discontinued. NPSG compliance will still be displayed on organization Quality Reports.
Are there any differences between the NPSG requirements and the Protocol requirements?
Yes. Although the two sets of requirements are quite similar, the Protocol is more specific in the following respects:
- Non-operative sites must NOT be marked.
- The site should be marked by the person who will do the procedure.
- Adhesive markers ("stickies") should NOT be used as the sole means of marking the surgical site.
- In addition to patient, procedure and site, the "time out" must include verification of correct patient position and availability of correct implants and any necessary special equipment.
- The "time out" must be documented.
What procedures fall within the scope of the Universal Protocol?
This Protocol and its Implementation Guidelines apply to all operative and other invasive procedures that expose patients to more than minimal risk, including procedures done in settings other than the operating room such as a special procedures unit, endoscopy unit, or interventional radiology suite. Certain routine "minor" procedures such as venipuncture, peripheral IV line placement, insertion of NG tube, or Foley catheter insertion are not within the scope of the Protocol. However, most other procedures that involve puncture or incision of the skin, or insertion of an instrument or foreign material into the body, including, but not limited to, percutaneous aspirations, biopsies, cardiac and vascular catheterizations, and endoscopies are within the scope of this Protocol.
Preop verification FAQs
Isn't this preoperative checklist thing just another onerous Joint Commission documentation requirement?
The requirement is for a "preoperative verification process." The checklist is an example of one approach—the most common one. The intent of the requirement is to ensure that all of the relevant documents are available prior to the start of the procedure and that they have been reviewed and are consistent with each other and with staffs' understanding of the intended patient, procedure and site. It is the process that is important, not the documentation. Surveyors will evaluate the consistency with which the preoperative verification process is performed, without mandating the use of a checklist if the organization has decided to use a different approach.
Site Marking FAQs
Does the site need to be marked for all procedures or is it just for right/left procedures?
Marking the site is required for procedures involving right/left distinction, multiple structures (such as fingers and toes), or levels (as in spinal procedures). Site marking is not required (nor is it prohibited) for other procedures. These may include mid-line sternotomy, Cesarean section, laparotomy and laparoscopy, cardiac catheterization and other interventional procedures for which the site of insertion is not predetermined. For those procedures in which site marking is not required, the other requirements for preventing wrong site, wrong procedure, wrong person surgery still apply.
In the FAQs for the NPSGs, there was a site-marking exemption for procedures done through a natural body orifice. Does that still apply? What if the incision/insertion site is midline but the organ to be operated on is right or left?
Our original advice concerning "orifices" was that site marking was not required for procedures done through or immediately adjacent to "natural body orifices." This was intended to include mid-line orifices such as mouth, anus, urethra. However, many procedures done through a mid-line orifice are intended to treat an organ that is "right" or "left" and therefore subject to a lateralization error. Similarly, many "open" or endoscopic procedures are done through a mid-line incision or insertion site but are intended to treat an organ that is "right" or "left." Based on the above and the requirement for marking all cases involving lateralization, organizations must establish procedures for marking the skin at or near the proposed incision/insertion site to indicate the correct side of the proposed procedure, even when the proposed incision/insertion site is in the mid-line or through a natural body orifice. This mark, as for other site marks, must be positioned to be visible after the patient is prepped and draped unless it is technically or anatomically impossible or impractical to do so. In such technically difficult cases, an alternative method for visually identifying the correct side should be used (e.g., a temporary unique wrist band or other similar device).
What about dental procedures? I understand there have been several cases of extraction of the wrong teeth.
The American Dental Association (ADA) has been very supportive of efforts to eliminate wrong site surgery, including wrong dental extractions. However, the ADA acknowledges that there does not appear to be a practical or reliable method to actually mark the teeth that are intended for extraction. Therefore, dental procedures will be considered exempt from the site marking requirement. In lieu of directly marking the teeth, the ADA recommends—and the Joint Commission concurs with—the following:
- Review the dental record including the medical history, laboratory findings, appropriate charts and dental radiographs. Indicate the tooth number(s) or mark the tooth site or surgical site on the diagram or radiograph to be included as part of the patient record.
- Ensure that radiographs are properly oriented and visually confirm that the correct teeth or tissues have been charted.
- Conduct a "time out" to verify patient, tooth and procedure with assistant present at the time of the extraction (two person rule).
Does the site have to be marked if there is an obvious wound or lesion?
In general, site marking is not required if there is an obvious wound or lesion that is the site of the intended procedure. However, if there are multiple wounds or lesions and only some of them are to be treated, and the decision and direction for which ones are to be treated is determined at some time prior to the procedure itself, then the sites to be treated should be marked as soon as possible after the decision is made.
Is marking of the site necessary for bedside procedures such as chest tube insertion?
Some of these "bedside" procedures do carry significant risk with respect to the consequences of a "wrong site" or "wrong patient" procedure. Our position on this situation takes into consideration the timing and continuity of contact between the patient and the practitioner performing the procedure. For cases that would otherwise require site marking (see above), if the practitioner performing the procedure remains with the patient continuously from the time the decision is made to do the procedure (and consent is obtained from the patient) up to the time of the procedure itself, then site marking is not required. However, if the person performing the procedure leaves the presence of the patient for any amount of time during that interval, then the site should be marked (before leaving the patient).
Some of these cases may be done as emergency procedures. What then?
As always, the overarching goal is patient safety, so none of these precautions should interfere with the timely care of the patient in an emergency situation. In most of these cases, when invasive procedures are performed under emergency or urgent conditions, the practitioner performing the procedure will be in continuous attendance of the patient from the point of decision to do the procedure. Under those circumstances, marking the site would not be necessary, although the "time-out" to verify the correct patient, procedure, and site would still be appropriate (unless it was such an emergency that even the time out would add more risk than benefit). In a more elective situation, marking the site is expected for "right/left," multiple structure, multiple level procedures that carry significant risk if performed on the wrong patient or at the wrong site.
Who should mark the site?
The Protocol states, "The person performing the procedure should do the site marking." The word "should" is in contrast to the more definitive term "must," which is used elsewhere in the Protocol. It recognizes the need for flexibility to accommodate the logistical and procedural realities of the full range of surgical facilities. When it is not feasible for the person performing the procedure to mark the site, another member of the surgical team who is fully informed about the patient and the intended procedure must do the marking. In this context, the preoperative registered nurse is considered a member of the surgical team. Any delegation of responsibility for marking the surgical site must be consistent with applicable law and regulation (we are advised that some states may prohibit nurses from marking the surgical site). The organization must ensure that whenever the responsibility for site marking is delegated to someone other than the person who will be doing the procedure, the safety of the patient will not be compromised. Note that while the Protocol requires that the patient be involved in the process, it is not expected, or even recommended, that the patient mark his/her own surgical site.
When should the site be marked?
Site marking should be done prior to moving the patient into the room where the procedure will be done. Part of the requirement is that the site marking be done "with the involvement of the patient." For this to be done in a meaningful way, it should happen before the patient is significantly sedated. Participation may be precluded by a disease state or heavy sedation. However, sedation by itself does not necessarily prevent the patient from participating in the site marking process. The patient's capacity to participate must be based on an individual assessment.
What if the patient cannot participate in the marking process?
In cases of non-speaking, comatose, or incompetent patients, or children, the "patient involvement" in the site marking process should be handled in the same way that you handle the informed consent process. Whoever has authority to provide informed consent for the patient to undergo the procedure would, as appropriate, participate in the site marking process.
What if the patient refuses site marking?
The patient always has the right to refuse. This situation should be handled the same way as for any other refusal by a patient offered care, treatment or services. The organization's responsibility is to provide the patient with information to understand why site marking is appropriate and desirable, and the implications of refusing the site marking. Then the patient can make an informed decision. The Protocol does not require that the procedure be cancelled because the patient refuses site marking. Organization policy should describe the related procedural and documentation requirements.
How should the site be marked (an "X," the word "Yes," the surgeon's initials)?
The Protocol does not specify the type of mark—that is left to the organization to decide—but whatever the decision on this, the mark must be unambiguous and the process should be consistent throughout the organization. Consideration should be given to aligning the site marking procedures with those of other surgical facilities in the same geographic area, since surgeons are frequently on multiple medical staffs. Use of "X" is discouraged since this may be ambiguous: Does "X" mean operate here or do not operate here? A line indicating the intended site of incision, the surgeon's initials, or the word "yes" are all preferable ways to mark the site.
What happens to the site mark when a patient requires multiple surgeries during their hospital stay?
The site mark should be removed at the end of the procedure, unless the surgical procedure will continue on the same site.[Added 5/24/04]
For "right/left" cases, is it acceptable to mark the opposite site with a "NO" rather than marking the intended operative site?
No, that is not acceptable. The Protocol specifies marking the intended site of the procedure. Marking the non-operative site instead of or in addition to the operative site is explicitly prohibited by the Protocol unless necessary for some other aspect of care (such as to warn against using a particular extremity for venous access because of a prior surgical procedure). [Updated 5/5/04]
Do you need to mark the site for laparoscopic procedures?
If the target site is for organs that are paired, site marking is required to indicate the intended side, even though the site of insertion of the instrument is in the midline. [Added 5/5/04]
What is the recommended procedure for marking spinal surgery cases?
For spinal surgery, we advise a two-stage marking process. First, the general level of the procedure (cervical, thoracic or lumbar) must be marked preoperatively. If the approach involves anterior versus posterior, or right versus left, then the mark must indicate this. Then, intraoperatively, the exact interspace(s) to be operated on should be precisely marked using the standard intraoperative radiographic marking technique. The requirement for the preoperative marking is based on reported cases in which a patient intended for a cervical procedure had a lumbar procedure started, and vice versa.
Our surgeons are concerned about an increased risk of wound infection from marking the surgical site. Is this a valid concern?
There is no evidence in the literature that suggests an increased risk of infection from this process. The surgical site should be prepared in the usual manner. Special surgical marking pens that will not be washed off by the surgical prep are available.
What kind of marker or pen should be used to mark the site?
A marker that is sufficiently permanent to remain visible and will not wash off when the site is prepped may be used for marking the site. Surgical markers or pens are available for purchase from several manufacturers. [Added 5/5/04]
Are adhesive site markers permitted under the Protocol?
Under the Universal Protocol, adhesive site markers are permitted as an adjunct to directly marking the skin. While the Protocol does not explicitly prohibit the use of adhesive markers, it does state, "Adhesive site markers should not be used as the sole means of marking the site." This means that when site marking is required, it must be done by directly marking the skin. Surgical marking pens and other direct skin marking methods are available that will allow marking of the skin such that the mark will remain visible after the skin prep is done, but can be removed following the procedure.
If site marking is not required for a particular procedure, are the other provisions of the Protocol still required?
Yes. Even if site marking is not required by this Protocol or by organization policy, the other requirements for a preoperative verification process and a "time out" still apply.
What specific surgical procedures require marking of the site? [Added 12/16/04]
Site marking is required by national patient safety goal 1b and is one requirement of the Universal protocol. In addition standard PC.13.20 EP 9 requires "the site, procedure, and patient are accurately identified and clearly communicated using active communication techniques, during a final verification process such as a time-out before the start of any surgical or invasive procedure."
As noted in our FAQs on the Joint Commission website, the Universal protocol requirements are applicable to all operative and other invasive procedures that expose patients to more than minimal risk, including procedures done in settings other than the operating room such as a special procedures unit, endoscopy unit, or interventional radiology suite. Certain routine "minor" procedures such as venipuncture, peripheral IV line placement, insertion of NG tube, or Foley catheter insertion are not within the scope of the protocol. In addition, marking the site is required for procedures involving right/left distinction, multiple structures (such as fingers and toes), or levels (as in spinal procedures). Site marking is not required (nor is it prohibited) for other procedures. These may include mid-line sternotomy, Cesarean section, laparotomy and laparoscopy, cardiac catheterization and other interventional procedures for which the site of insertion is not predetermined. However, most other procedures that involve puncture or incision of the skin, or insertion of an instrument or foreign material into the body, including, but not limited to, percutaneous aspirations, biopsies, cardiac and vascular catheterizations, and endoscopies are within the scope of the Universal Protocol.
Each organization will need to utilize this website explanation and identify which procedures that are being performed at their organization would expose the patient to more than minimal risk.
Beyond the FAQ explanations the Joint Commission cannot make that decision for organizations. Surveyors will use the organization's definition in evaluating compliance with the national patient safety goal, the universal protocol and the element of performance at PC.13.20.
Additionally, recognizing that Universal Protocol requirements promote safe patient care, treatment, and services, organization are certainly free to use any of the components of the protocol for any other type of procedure it so chooses.
Time Out FAQs
When should the "time out" occur?
The "time out," or immediate preoperative pause, must occur in the location where the procedure is to be done (for example, when the patient is on the operating table). Given this restriction, the "time out" may precede induction of anesthesia or may occur after the patient is anesthetized (participation by the patient is not expected) but just before starting the procedure.
Who should participate in the "time out" process?
The "time out" must involve the entire surgical team. At a minimum, this includes active participation by the surgeon, anesthesia provider, and circulating nurse. Participation by the other members of the team, as appropriate to their involvement in the procedure, is also encouraged. In particular, there should be no barrier to anyone speaking up if there is concern about a possible error. To include some members of the team but not others sends the wrong message.
What is meant by "active communication" as part of the "time out" process?
"Active communication" doesn't necessarily mean everyone has to repeat the same information. The members of the team may signal their agreement by a brief oral acknowledgement, a nod or some other gesture. The point is, absence of a response should not be interpreted as agreement.
What if there is only one person involved in doing the procedure, such as for some bedside procedures? Is a time out still expected? Should someone else be brought in to do the time out?
Even when there is only one person doing the procedure, a brief pause to confirm the correct patient, procedure, and site is appropriate. It is not necessary to engage others in this verification process if they would not otherwise be involved in the procedure.