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What’s New in the Patient Safety World

May 2022

PPSA: Updated Wrong-Site Surgery Recommendations

 

 

The Pennsylvania Patient Safety Authority has updated its “Recommendations to Ensure Correct Surgical Procedures and Correct Nerve Blocks” (PPSA 2022).

 

PPSA really stresses that it’s everyone’s responsibility to ensure correct patient, procedure, and laterality. That includes scheduling staff, registration clerks, ancillary staff, nursing staff, the operating provider, anesthesia provider, and the patient. All have an obligation to speak up if they note a discrepancy in any information on the schedule, consent, history and physical, and any office notes. Reconciliation of discrepancies is the responsibility of the operating provider prior to the procedure.

 

It also stresses the importance of having all relevant documents and imaging studies available. All parties should have reviewed these themselves rather than relying on others. It also stresses active, rather than passive, verification by the patient and others.

 

We’re glad to see an emphasis also on the importance of including site and side of the procedure at the time of initial scheduling. In several of our columns we have lamented that sometimes the scheduling is performed by non-clinical individuals on either side. In our October 30, 2012 Patient Safety Tip of the Week “Surgical Scheduling Errors” we noted the Minnesota Alliance for Patient Safety created a sample booking form that contains a section which must be filled out by the physician performing the surgery (i.e. that cannot be delegated to staff).

 

The PPSA recommendations have a good section on site marking. You may wish to also see our May 14, 2019      Patient Safety Tip of the Week “Wrong-Site Surgery and Difficult-to-Mark Sites” regarding sites that are difficult to mark, such as dental, ocular, or spine sites.

 

There is one area where we think better clarification is due. The recommendations state that “The provider performing the procedure should announce the time-out.” We don’t have a problem with that. But it should not mean that he/she “leads” the timeout. We like the “Minnesota Timeout” concept in which someone other than the surgeon leads the time out process. That helps prevent team members from simply agreeing with the surgeon. The timeout is supposed to be an active rather than passive process and there should not be undue deference to the surgeon. Every member of the team needs to speak up and not be afraid to challenge any aspect.

 

In the Minnesota Timeout, after the surgeon announces the timeout, the circulating Nurse reads from the patient’s informed consent the patient name, procedure, and laterality (or level), and notes the position of the patient. The anesthesia care provider reads patient’s name from the anesthesia record and states shorthand version of procedure. He/she also states antibiotic name, dose, and minutes from administration time. The scrub person states the shorthand version of procedure for which he/she has set up and verbally confirms he/she sees the surgical site marking (if there is a site marking). If an anatomical diagram is used in lieu of physical site marking, the circulating nurse and team use the diagram to verbally acknowledge the surgical site. The surgeon then states the patient’s name, complete procedure, and site—from memory. Discrepancies are resolved before procedure start.

 

What’s missing from the Minnesota Timeout? There is no mention of using the other primary source documents (scheduling form, office or hospital notes, history & physical) and no mention about presence and accuracy of appropriate imaging studies.

 

 

Here’s the full list of the PPSA recommendations:

 

Recommendations to ensure the correct surgical procedure is performed on the correct site, side and patient

 

Preoperative verification and reconciliation

 1. The site and side of procedure should be specified when the procedure is scheduled.

 2. The procedure, site and side should be noted in the medical record on the history and physical exam record or the procedure note.

 3. The procedure, site and side should be discussed and documented on the informed consent form.

 4. The individuals, including scheduling staff, registration clerks, ancillary staff, nursing staff, the operating provider and the patient, have an obligation to speak up if they note a discrepancy in any information on the schedule, consent, history and physical, and any office notes. Reconciliation of discrepancies is the responsibility of the operating provider prior to the procedure.

 5. The information to verify the correct patient, procedure, side and site, including the patient's or family's verbal understanding, when possible, must be verified by the circulating nurse/designee, anesthesia provider and operating provider. This verification shall be documented in a manner determined by the healthcare facility.

 6. Verbal verification with the patient or their representative should be conducted whenever possible.  The verbal verification must be done using questions that require active response of specific information rather than passive agreement. Example: Can you tell me your full name? What is your date of birth? What procedure are you having performed today?

 7. Patient identification must require at least two unique identifiers, for example, name and date of birth.

 8. Discrepancies must be reconciled and documented by the operating provider prior to the procedure.

Site Marking—Site marking recommendations apply to all procedures where there is more than one possible location for the procedure.

 9. The site must be marked by the provider responsible for the procedure, for example, surgeon, proceduralist or interventional radiologist, prior to the patient entering the procedure area. The mark must be confirmed by the attending nurse/designee. The mark must also be confirmed by an alert patient or patient representative when possible. The mark must coincide with the schedule, history and physical, and consent.

 10. The site must be marked with the provider's initials with an indelible marker.

 11. The mark must be made as close to the incision site as possible, so that it is visible in the prepped and draped field.

 

Time-out and intraoperative verification

 12. Prior to the induction of anesthesia, the circulating nurse and the anesthesia provider, verify the patient's identity, procedure, site, side, consent and site marking. The patient is included in this verification whenever possible.

 13. The provider performing the procedure should announce the time-out. This occurs after the patient is prepped and draped, and immediately prior to skin incision/puncture.

 14. Separate formal time-outs must be done for separate procedures, including anesthetic blocks, by the person performing that procedure.

 15. The noncritical activities in the procedure area must stop during the time-out, including music and nonessential talking that could distract team members.

 16. The relevant patient documents should be available and actively confirmed during the time-out process. Relevant documents include a history and physical, consent, operating room schedule and radiographic studies when applicable.

 17. The site mark should be referenced in the prepped and draped field during the time-out.

 18. The members of the surgical team should actively and verbally verify agreement with the surgical site, side and relevant documents. Active participation should be used at all times. For example, ''Which side is the surgery on?'' instead of ''The surgery is on the left side. Do you agree?''

 19. Staff should be engaged in the process and the operating provider should specifically encourage team members to speak up with any concerns during the time-out. The operating provider is responsible for resolving any questions or concerns based on primary sources of information and to the satisfaction of all members of the team before proceeding.

 20. Utilize intraoperative imaging whenever possible for procedures where exact site is not easily determined through external visualization, for example, X-ray and fluoroscopy, to verify spinal level, rib section level or ureter to be stented.

 

Accountability

 21. Incorporate accountability for these recommendations into the facility's quality assurance and formal evaluation process. This includes both individual and team performance evaluations, ongoing professional practice evaluations and focused professional practice evaluations.

 

Recommendations to ensure nerve blocks are performed at the correct site and correct patient

 

Preoperative verification and reconciliation

 1. Confirm patient identity using at least two forms of patient identification.

 2. Reconcile and verify the exact site and laterality of the surgical procedure and the perioperative nerve block site using all forms of available primary and confirmatory patient sources, including surgical consent, patient or representative, or both, operative provider's notes (if available), surgical schedule, and history and physical.

 3. If any sources differ, the process stops and a member from the anesthesia block team notifies the surgeon to resolve the conflicting information.

 

Anesthesia site marking

 4. After confirming the information in the preoperative verification, the responsible anesthesia provider will use a standardized, institutionally approved mark that is distinct from the one used for the surgical site to mark the perioperative nerve block site.

 5. Place the mark close to the injection site to ensure it is visible in the prepped and draped field.

 6. Repeat the marking process when there are multiple injection sites.

 

Time out

 7. Secure a block team consisting of at least two people with independent roles (for example, responsible anesthesia provider and preoperative or holding area nurse or circulating nurse).

 a. Engage the anesthesia provider to initiate the time-out.

 b. The anesthesia provider should be present during the time out and during the nerve block.

 8. Conduct a time-out before:

 a. Sedating the patient, when possible.

 b. Inserting the needle or as close to the procedure as possible.

 c. Each nerve block.

 9. Minimize distractions and stop all unrelated activity before conducting the time-out.

 10. Both the anesthesia provider and block team member verify the procedure that is documented and on the surgical consent (and anesthesia consent if used).

 11. Locate and visibly confirm the anesthesia site mark during the time-out.

 12. Repeat the time-out process when there are changes to:

 a. Block team.

 b. Patient location within the perioperative area.

 c. Patient positioning.

 d. Planned nerve block site.

 

Accountability

 13. Incorporate accountability for these recommendations into the facility's quality assurance and formal evaluation process. This includes both individual and team performance evaluations, ongoing professional practice evaluations and focused professional practice evaluations.

 

 

The PPSA recommendations appear to be aimed at those surgeries and other procedures that are likely performed in an OR or procedural room. Don’t forget that many of the same principles should apply for those procedures done at the bedside (see our columns for June 6, 2011 “Timeouts Outside the OR”, July 2014 “Wrong-Sided Thoracenteses, and February 15, 2022 “Wrong-Side Chest Tubes”).

 

 

We should also mention that a recent article in Outpatient Surgery (Gapinski-Kloiber 2022) described use of a mobile software application that might help avoid wrong site surgery. “Surgeons can use the platform to record their discussions with patients in the clinic about the planned procedure, including the site and laterality. This cloud-based statement of the intended surgical plan and verbal confirmation by the patient is accessible leading up to the procedure, including just before the time out, to help providers confirm the correct patient and site. The platform also has a visual cue component, which uses alliteration and colors to help staff identify the correct site of the surgery. A member of the pre-op team uses the platform’s app to listen to the recording of the surgeon-patient statement and scans the proper procedure card into the system. In the OR, members of the surgical team also listen to the statement before conducting the safety time out, which is recorded by the app.“ 

 

“In a study involving use of this technology, researchers found no incidences of wrong-site surgery in 487 orthopedic procedures. However, the tool did catch 17 near misses. The researchers were surprised by how many seemingly small errors occurred, including misspelled names and laterality mistakes, and that they were caught at various points of care between surgeons’ offices and operating rooms. The technology can track these close calls and advance staff education and communication by reporting them objectively to surgical leadership.”

 

 

Some of our prior columns related to wrong-site surgery:

 

  September 23, 2008 Checklists and Wrong Site Surgery

  June 5, 2007              Patient Safety in Ambulatory Surgery

  July 2007                  Pennsylvania PSA: Preventing Wrong-Site Surgery

  March 11, 2008         Lessons from Ophthalmology

  July 1, 2008              WHO’s New Surgical Safety Checklist

  January 20, 2009       The WHO Surgical Safety Checklist Delivers the Outcomes  

  September 14, 2010 Wrong-Site Craniotomy: Lessons Learned

  November 25, 2008 Wrong-Site Neurosurgery

  January 19, 2010       Timeouts and Safe Surgery

  June 8, 2010              Surgical Safety Checklist for Cataract Surgery

  December 6, 2010     More Tips to Prevent Wrong-Site Surgery

  June 6, 2011              Timeouts Outside the OR

  August 2011             New Wrong-Site Surgery Resources

  December 2011         Novel Technique to Prevent Wrong Level Spine Surgery

  October 30, 2012      Surgical Scheduling Errors

  January 2013             How Frequent are Surgical Never Events?

  January 1, 2013         Don’t Throw Away Those View Boxes Yet

  August 27, 2013       Lessons on Wrong-Site Surgery

  September 10, 2013 Informed Consent and Wrong-Site Surgery

  July 2014                  Wrong-Sided Thoracenteses

  March 15, 2016         Dental Patient Safety

  May 17, 2016            Patient Safety Issues in Cataract Surgery

  July 19, 2016            Infants and Wrong Site Surgery

  September 13, 2016 Vanderbilt’s Electronic Procedural Timeout

  May 2017                  Another Success for the Safe Surgery Checklist

  May 2, 2017              Anatomy of a Wrong Procedure

  June 2017                  Another Way to Verify Checklist Compliance

  March 26, 2019         Patient Misidentification

  May 14, 2019            Wrong-Site Surgery and Difficult-to-Mark Sites

  May 2020                  Poor Timeout Compliance: Ring a Bell?

  September 14, 2021 Wrong Eye Injections

  October 5, 2021        Wrong Side Again

  November 9, 2021    Ensuring Safe Site Surgery

  February 15, 2022     Wrong-Side Chest Tubes

 

 

References:

 

 

Patient Safety Authority/Department of Health. Final Recommendations to Ensure Correct Surgical Procedures and Correct Nerve Blocks. Pennsylvania Bulletin 2022; 52(12): 1591-1724 March 19, 2022

https://www.pacodeandbulletin.gov/Display/pabull?file=/secure/pabulletin/data/vol52/52-12/448.html

 

 

Minnesota Alliance for Patient Safety. Sample booking form

https://mnpatientsafety.org/sites/default/files/uploads/attachments/surgery-scheduling-form-example.pdf

 

 

Harder KA. Safe Surgery Process Steps (including the Minnesota Time Out) to Prevent Wrong Surgery. Minnesota Department of Health

https://www.health.state.mn.us/facilities/patientsafety/adverseevents/publications/safesurgery.pdf

 

 

Gapinski-Kloiber K. Why Does Wrong-Site Surgery Keep Happening? Put policies in place to make sure surgeons always cut where they should. Outpatient Surgery 2022; April 7, 2022

https://www.aorn.org/outpatient-surgery/articles/outpatient-surgery-magazine/2022/april/wrong-site-surgery

 

 

 

 

 

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