2009 Universal Protocol FAQs . . . finally here

Accreditation Monthly

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November 14, 2008

I'm sure you have all been waiting with bated breath for the 2009 Universal Protocol (UP) FAQs. Seldom have I seen such confusion or lack of clarity around a standard. I'll discuss some of the more controversial or less understood points. You can find the full FAQs at www.jointcommission.com.

What procedures fall within the scope?
The definition has not changed: "All operative and other invasive procedures that expose patients to more than minimal risk."

The FAQs provide some clarity around the phrase "puncture or incision of the skin, insertion of an instrument, or insertion of foreign material into the body." The FAQs state that "…certain routine ‘minor’ procedures" such as the following, are NOT within the scope of the protocol:

• Venipuncture
• Peripheral intervenous line placement
• Insertion of a nasogastric tube
• Urinary catheter placement
• ECT
• Closed reduction
• Radiation oncology
• Lithotripsy (this does have laterality, but the stone is visualized during the procedure)
• Dialysis (except insertion of the dialysis catheter)

Examples of procedures that ARE covered by the UP include:

• PICC line
• Central line insertion
• Chest tubes and other similar types of common procedures

The FAQs go on to state that "each organization is expected to clearly define those procedures that fall within the protocol". Although this statement references the term "procedures," it seems that they could be defined in groups, such as "all procedures performed in the OR suite", "all procedures performed in special procedure areas", etc rather than a list of individual procedures. Procedures done at the bedside require some thought and some decision as to what puts the patient at "more than minimal risk".

Is a preprocedure checklist now required?
Yes, and it needs to be completed PRIOR to moving the patient into the OR or procedure room. The checklist should include:

• All relevant documents present
• Blood products, if ordered
• Implants
• Special equipment

If the staff in the preprocedure area do not have access to some of the information (e.g., blood, special equipment, implants), the organization would be expected to implement a communication process between the two areas ensuring the required elements are available and ready for use. They go on to say: "In those unusual circumstances when this verification cannot be performed during the preop verification process, the confirmation may be done at the time out … this should be based on individual circumstances, and should not be routine practice."

Must all procedures be marked?
The intent of site marking has not changed. It still must be performed for laterality, levels, and multiples. The mark must be visible after prepping and draping, etc. Exemptions to site marking include:

• Midline, single organ procedures
• Endoscopies without laterality
• When there is no predetermined insertion site such as cardiac catheterization and other interventional procedures

If the site cannot be marked, will not be visible after draping, or the patient refuses site marking, an alternative process must be clearly identified (such as a wristband with description of site, a mark on the same side as the procedure, etc). This needs to be defined in the policy.

Time Out
You may have noted some contradictions about time outs.

• On one hand, the FAQ requires one, and only one, time out for most surgeries: either before anesthesia, or after anesthesia and prior to incision. On the other hand, the FAQ seems to require two time outs when a spinal or regional block is involved: prior to the block, and again prior to incision. (hmmmm …?)
• On one hand the FAQ indicates that only one time out is necessary when the same team will perform all portions of a multipart procedure. On the other hand it requires a separate time out when the various parts of the procedure require separate consent forms.

The bottom line: "Each organization defines under which situations the time out is required to be performed prior to anesthesia or when it is preferable to do so immediately prior to the procedure/incision; or when flexibility may be considered …". One way to interpret this is to ask "does the anesthesia have laterality where an error could be made?" Also, the proceduralist may not be present during the anesthesia, therefore, define who is responsible to conduct the timeout? (Anesthesia staff introducing the anesthesia and procedural assistants seems reasonable).

Documentation
All aspects of the universal protocol must now be documented (UP.01.03.01 EP.6). However, some parts of the protocol do not lend themselves to documentation, such as verification of the procedure during scheduling or a checklist that is on a wallboard instead of a form.

Question of the Month | Expert Advice & Guidance

•  I've heard that medication containers have to be labeled in areas other than procedural locations or the operating room. Is this true?

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