PATIENT SAFETY AUTHORITY
DEPARTMENT OF HEALTH
Draft Recommendations to Ensure Correct Surgical Procedures and Correct Nerve Blocks
[51 Pa.B. 6740]
[Saturday, October 23, 2021]
This document outlines draft recommendations to hospitals, ambulatory surgery facilities, birthing centers and abortion facilities in this Commonwealth to ensure the correct procedure is performed on the correct site, side and patient. A 30-day public comment period will follow publication.
The Patient Safety Authority (Authority) is responsible for submitting recommendations to the Department of Health (Department) for changes in healthcare practices and procedures, which may be instituted for the purpose of reducing the number and severity of serious events and incidents. Once approved by the Department, the Authority is responsible for issuing recommendations to acute and ambulatory care facilities in this Commonwealth. These draft guidelines were approved by the Authority's Board of Directors and the Acting Secretary of Health.
Instructions for submitting comments are at the end of this document.
Wrong-site surgery (WSS) is a patient safety event that should never occur.
The National Quality Forum (NQF) defines surgery as ''an invasive operative procedure in which skin or mucous membranes and connective tissue is incised or an instrument is introduced through a natural body orifice.''1 ''Surgery begins, regardless of setting, at the point of surgical incision, tissue puncture, or the insertion of an instrument into tissues, cavities, or organs. Surgery ends after counts have concluded, the surgical incision has been closed, and/or operative device(s) such as probes have been removed, regardless of setting.''1 These recommendations apply to all procedures requiring informed consent in this Commonwealth.
In support of the NQF definition of surgery, the Authority affirms that surgery is not limited to those procedures done in an operative room setting. Surgery includes procedures performed in other clinical departments of the healthcare facility including those performed at the bedside.
The Authority has tracked WSS since July 2004. During that third quarter of 2004 (July—September) there was an average of 1.33 WSS events per week across this Commonwealth.2 Fast-forward to the most recent study (2015—2019) and this Commonwealth is still experiencing 1.42 WSS events per week. These 368 events took place in 178 facilities in this Commonwealth.3 As of December 2019, 380 licensed acute care facilities in this Commonwealth had not reported a WSS in the previous 5 years.
Prevention guidelines are well established. The Joint Commission first issued The Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person SurgeryTM in 2003.4 The World Health Organization created the WHO Surgical Safety Checklist in association with the Harvard School of Public Health in 2008 to improve the safety of patients undergoing surgical procedures.5 In September 2011, the Authority identified and published ''Principles for Reliable Performance of Correct-Site Surgery'' based on its findings during its Preventing Wrong-Site Surgery project.6 The Authority published evidence to support each of the principles in the Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person SurgeryTM in 2011 and revised this document in 2017.7 The Authority and the Pennsylvania Society of Anesthesiologists issued a consensus document ''Principles for Reliable Performance of Correct-Site Nerve Blocks'' in 2018.8
The Authority continues to support these prevention guidelines and believes WSS events continue to happen largely due to noncompliance with the established guidelines. The Authority conducted a survey of patient safety officers in this Commonwealth to identify barriers related to the implementation of prevention guidelines.
Barriers largely fell into two categories: noncompliance (including complacency, distractions and lack of buy-in) and time constraints.
The Authority is charged with issuing recommendations to medical facilities on a facility-specific or Statewide basis regarding changes, trends and improvements in healthcare practices and procedures, for the purpose of reducing the number and severity of serious events and incidents. Prior to issuing recommendations, consideration must be given to the expectation of improved quality care; implementation feasibility; other relevant implementation practices; and the cost impact to patients, payors and medical facilities.
The Authority submits that improved quality of care by following the principles it identifies for reliable performance of correct-site surgery is expected due to the supported evidence for each principle first published in 2011. The Authority submits that feasibility of implementation is no longer a consideration, as these practices are well established in the industry and have been implemented by most healthcare organizations across this Commonwealth, the United States and several parts of the world.
Medical facilities face nonpayment penalties for WSSs, as well as the cost of litigation when these events occur. Negative cost implications for medical facilities may include the cost of training and the administrative cost related to quality assurance programs. The Authority does not believe that a cost will be incurred related to lost operating room time, as a time-out is already an accepted standard practice. The Authority is not recommending the length of the time-out be extended, but rather a concerted focus on the quality of the time spent during the time-out. There is no negative cost implication for patients or payors. While direct costs associated with wrong-site surgeries are not reimbursed by most payors, there may be indirect long-term costs incurred with resulting health issues. Patients may experience out-of-pocket expenses for long-term effects of WSS and working individuals may experience a longer than expected absence from the workforce or be unable to return to the workforce at all.
Recommendations to ensure the correct surgical procedure is done 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.9, 10
2. The procedure, site and side should be noted in the medical record on the history and physical exam record.9, 10
3. The procedure, site and side should be discussed and documented on the informed consent form.9, 10
4. Verification and reconciliation of information on the schedule, consent, history and physical, and any office notes are the responsibility of all staff members—including scheduling staff, registration clerks, ancillary and nursing staff, and operating provider—and the patient themselves.9—15
5. All information to verify the correct patient, procedure, side and site, including the patient's or family's verbal understanding, must be verified by the circulating nurse, anesthesia provider and operating provider.9, 10 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. All 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?9, 10
7. Patient identification must require at least two unique identifiers, for example, name and date of birth.9, 10
8. Discrepancies must be reconciled and documented by the operating provider prior to the procedure.9—12, 14—16
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 or interventional radiologist, prior to the patient entering the procedure area. The mark must be confirmed by the attending nurse and an alert patient or patient representative. The mark must coincide with the schedule, history and physical, and consent.9—11, 14—18
10. The site must be marked with the provider's initials with an indelible marker.9—11, 14—21
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.9—11, 15—18
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.5
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.9, 10, 17, 20, 21
14. Separate formal time-outs must be done for separate procedures, including anesthetic blocks, by the person performing that procedure.9—11, 17, 21
15. Noncritical activities in the procedure area must stop during the time-out, including music and nonessential talking that could distract team members.9—11, 14, 17
16. Relevant patient documents should be available and actively confirmed during the time-out process.9—11 Relevant documents include a history and physical, consent, operating room schedule, radiographic studies when applicable, and office notes.
17. The site mark should be referenced in the prepped and draped field during the time-out.9, 10, 21
18. 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?''9, 10, 14, 17, 19, 20—22
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.9—11, 14, 19—22
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.9, 10, 14, 17, 23
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.8
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.8
3. If any sources differ, the process stops and a member from the anesthesia block team notifies the surgeon to resolve the conflicting information.8
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.8
5. Place the mark close to the injection site to ensure it is visible in the prepped and draped field.8
6. Repeat the marking process when there are multiple injection sites.8 Time-Out.
7. Secure a block team consisting of at least two people with independent roles (for example, responsible anesthesia provider and pre-operative or holding area nurse or circulating nurse):8
a. Engage the anesthesia provider to initiate the time out.8
b. The anesthesia provider should be present during the time-out and during the nerve block.8
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.8
9. Minimize distractions and stop all unrelated activity before conducting the time-out.8
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).8
11. Locate and visibly confirm the anesthesia site mark during the time-out.8
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 site8 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.
Instructions for Submitting Comments
Comments will be accepted for 30 days following the publication of this document. Comments may be submitted to the Patient Safety Authority, Attention: Bulletin Response, 333 Market Street, Lobby Level, Harrisburg, PA 17101, or by e-mail to email@example.com, include Bulletin Response in the subject line.
Both the Authority and the Department have a common goal of reviewing the public comments to this document, making selected changes in response to those comments and issuing final recommendations.
REGINA M. HOFFMAN, MBA, BSN, RN, CPPS,
Patient Safety Authority
Department of Health
1. National Quality Forum. Patient Safety Terms and Definitions. National Quality Forum, Washington D.C., 2009.
2. J. R. Clarke. Quarterly Update on Wrong Site Surgery. Pa Patient Saf Advis. 2014; 172-5.
3. Yonash, R., & Taylor, M. Wrong-Site Surgery in Pennsylvania During 2015—2019: A Study of Variables Associated With 368 Events From 178 Facilities. Patient Saf. 2020;2(4):24—39, 98. https://doi.org/10.33940/data/2020.12.2.
4. The Joint Commission. Joint Commission Saves Lives Timeline. Available: https://www.jointcommission.org/resources/news-and-multimedia/joint-commission-saves-lives/timeline/. (Accessed 31 December 2020).
5. World Health Organization. Patient Safety. Available: https://www.who.int/news/item/24-06-2008-new-checklist-to-help-make-surgery-safer. (Accessed 31 December 2020).
6. ECRI Institute on behalf of the Patient Safety Authority. Principles for Reliable Performance of Correct-Site Surgery. September 2011. Available: http://patientsafety.pa.gov/pst/Pages/Wrong%20Site%20Surgery/principles.aspx.
7. ECRI Institute on behalf of the Patient Safety Authority. Wrong-Site Surgery Principles. 13 October 2017. Available: http://patientsafety.pa.gov/pst/Documents/Wrong%20Site%20Surgery/u_principles.pdf. (Accessed 31 December 2020).
8. Arnold, T. & Martin, D. Peer Driven Principles Promote Correct Site Nerve Blocks. ASRA News. American Society of Regional Anesthesia and Pain Medicine. August 2018. Available: https://www.asra.com/news-publications/asra-updates/blog-landing/asra-news/2018/07/30/peer-driven-principles-promote-correct-site-nerve-blocks. (Accessed 31 December 2020).
9. J. R. Clarke. Quarterly Update: What Might Be the Impact of Using Evidence-Based Best Practices for Preventing Wrong-Site Surgery? Pa Patient Saf Advis. 2011:109-13.
10. Patient Safety Authority. Principles for Reliable Performance of Correct-Site Surgery. Preventing Wrong Site Surgery Project. Available: http://patientsafety.pa.gov/pst/Documents/Wrong%20Site%20Surgery/principles.pdf.
11. The Joint Commission. National Patient Safety Goals Effective July 2020 for the Hospital Program. Oakbrook Terrace, 2020.
12. J. R. Clarke, J. Johnston & E. Finley. Getting Surgery Right. Ann Surg. 2007;246(3):395—405.
13. J. R. Clarke. Is Your Office Helping You Prevent Wrong-Site Surgery? Bull Am Coll Surg. 2014;99(4):28—31.
14. Association of Perioperative Registered Nurses (AORN). Actions to Prevent Wrong-Patient, Wrong-Site, Wrong-Procedure Events. Wrong Site Surgery Resources. Available: https://www.aorn.org/education/staff-development/prevention-of-sentinel-events/wrong-site-surgery.
15. S. Ludwick. Surgical Safety: Addressing the JCAHO Goals for Reducing Wrong-Site, Wrong-Patient, Wrong-Procedure Events. Advances in Patient Safety. 2005:483-92.
16. M. R. Kwaan, D. M. Studdert, M. J. Zinner & A. A. Gawande. Incidence, Patterns, and Prevention of Wrong-Site Surgery. Arch Surg. 2006;141(4):353-8.
17. D. A. Wong et al. Sign, Mark & X-Ray. Prevention of Wrong-Site Spinal Surgery. North America Spine Society, Burr Ridge, IL, 2014.
18. Minnesota Hospital Association. Site Marking Recommendations and Guidance. Patient Safety: Call to Action. 2010.
19. V. Hanchanale, A. R. Rao, H. Motiwala & O. A. Karim. Wrong Site Surgery! How Can We Stop It? Urol Ann. 2014;6(1):57—62.
20. K. Chrouser, F. Foley, M. Goldenberg, J. Hyder, F. J. Kim, J. Maranchie et al. Optimizing Outcomes in Urologic Surgery: Intraoperative Considerations. American Urological Association. 2018.
21. The American Academy of Orthopaedic Surgeons. Information Statement: Surgical Site and Procedure Confirmation. 2015.
22. Patient Safety Authority. The Role of Empowerment in Patient Safety. Pa Patient Saf Advis. 2004;1(4):1-2.
23. J. DeVine, N. Chutkan, D. C. Norvell & J. R. Dettori. Avoiding Wrong-Site Surgery: A Systematic Review. Spine. 2010;35(9S):S28—S36.
[Pa.B. Doc. No. 21-1784. Filed for public inspection October 22, 2021, 9:00 a.m.]
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