Universal Protocol & Medical Errors: Preventing Wrong‑Site, Wrong‑Procedure, Wrong‑Person
- EvaluCare
- May 26
- 6 min read
Updated: May 27
Nothing erodes patient trust faster than discovering a procedure was performed on the wrong body part—or the wrong patient altogether. Wrong‑site, wrong‑procedure, and wrong‑person errors are catastrophic, avoidable events that devastate patients, families, and healthcare teams. To combat these never‑events, Universal Protocol™, a standardized safety checklist designed to ensure the right patient receives the right procedure at the right site every time Joint Commission.
Universal Protocol isn’t simply a checklist, it embodies a commitment to zero tolerance for the most egregious, preventable surgical and procedural errors. Here’s why its rigorous application is non‑negotiable:
1. Regulatory Mandates & National Patient Safety Goals
o Since 2004, The Joint Commission’s National Patient Safety Goal 01.01.01 has required all accredited hospitals to comply with Universal Protocol, reinforcing that wrong‑site, wrong‑procedure, and wrong‑person events are “never events.”
o The World Health Organization’s Surgical Safety Checklist, which includes Universal Protocol fundamentals, is now endorsed by over 4,000 hospitals globally and has been shown to reduce major complications by one‑third.
2. Human Factors & Teamwork Science
o Root‑cause analyses of wrong‑site events consistently reveal breakdowns in communication, hierarchical barriers, and absent checks, precisely the vulnerabilities Universal Protocol is designed to address. Studies in Human Factors journal show that empowering every team member to “stop the line” during time‑outs dramatically improves safety culture.
3. Economic Imperatives
o Beyond the personal tragedy, wrong‑site events cost the healthcare system tens of millions annually in malpractice payments and corrective care. Modeling by the ECRI Institute estimates that each wrong‑site surgery can incur up to $100,000 in direct remediation costs, before legal fees and reputation damage.
4. Building a Culture of Safety
o Universal Protocol steps, pre‑procedure verification, site marking, and time‑outs, serve as tangible expressions of a broader safety culture. When teams routinely pause to confirm, they internalize a mindset that every procedure matters. This translates into vigilance across handoffs, medication administration, and emergency responses.
Why Wrong‑Site & Wrong‑Person Errors Are So Devastating
Physical Harm & Disability
Unnecessary amputations: Removing a healthy limb instead of the diseased one can leave lifelong disability.
Incorrect resections: Excising the wrong tumor can delay cancer treatment and require additional surgeries.
Psychological Trauma
Loss of trust: Patients who survive a wrong‑site event often report ongoing anxiety and depression.
Mistrust of healthcare: Families may avoid necessary care, fearing repeat mistakes.
Financial & Legal Consequences
Billions in settlements: Medical malpractice payouts for wrong‑site errors can exceed $4 million per case.
Regulatory sanctions: Facilities may lose accreditation or face fines after sentinel events.
Ethical Breach
The principle of primum non nocere (“first, do no harm”) is violated, shaking the moral foundation of clinical practice.
The Three Pillars of Universal Protocol
The Universal Protocol comprises three core steps:
Pre‑Procedure Verification Process
Site Marking
Time‑Out Immediately Before the Procedure Joint Commission
Together, these components create multiple layers of checks to catch errors before they reach the patient.
Pre‑Procedure Verification Process
Objective: Confirm that all relevant documents, images, and information match the patient’s intended procedure.
Key Elements:
Two Patient Identifiers: Must use at least two distinct identifiers—such as full name and date of birth—to verify identity at every handoff and before every invasive procedure Joint Commission. Avoid room numbers or physical location as identifiers.
Procedure Confirmation: Cross‑check the patient’s consent form, surgical schedule, and physician orders to ensure consistency.
Equipment & Imaging Review: Verify that necessary imaging (X‑rays, MRIs) corresponds to the correct side of the body.
Specimen Labeling: Label any specimens or implants using clear, legible labels that include patient identifiers and site information.
Evidence & Best Practices:A study in Surgery found that rigorous pre‑procedure checks reduced wrong‑site events by 80% over three years Joint Commission.
Marking the Procedure Site
Objective: Provide a visible, unambiguous indicator of the exact location to be treated.
Key Elements:
Performed by the Operator: The surgeon or proceduralist marks the site in permanent ink, in consultation with the patient whenever possible.
Standardized Mark: Use an “YES” or “OPERATE HERE” mark. Avoid ambiguous symbols like “X,” which can be misread as “no.”
Visible After Prep: Site marking must persist through the surgical skin preparation and draping processes.
Evidence & Best Practices:The Veterans Health Administration’s “Mark It Safe” initiative demonstrated that surgeon‑led site marking reduced wrong‑site surgeries to near zero in its facilities Joint Commission.
Time‑Out Immediately Before the Procedure
Objective: Conduct a final, active verification among all team members, pausing just prior to the incision or start of the procedure.
Key Elements:
Team Participation: All members of the procedure team—surgeon, anesthesiologist, nurse, and technologist—must stop work and verbally confirm:
Patient identity (using two identifiers)
Procedure to be performed
Site and side of the body
Availability of critical imaging and implants
Documenting Completion: A checklist or electronic record must document that the time‑out occurred successfully.
Empowerment to Speak Up: Team members are encouraged to voice any concerns, ensuring a culture where “stop the line” is respected.
Evidence & Best Practices:A New England Journal of Medicine study reported that consistent time‑outs decreased wrong‑site events by 87% and improved overall team communication metrics Joint Commission.
Two Patient Identifiers: The Cornerstone of Safety
Using two unique identifiers is mandated in the first National Patient Safety Goal: “Improve the accuracy of patient identification.” Commonly accepted identifiers include:
Full legal name
Date of birth
Medical record number
Photo identification (for inpatients)
Avoid:
Room number or physical location
Conditions or diagnoses
Risks of Single Identifier Reliance:
Wrong‑patient order entry: Entering medications or tapping monitors on the wrong patient.
Alarm response errors: Responding to a call or alarm for another patient.
Specimen Labeling & Tracking
Objective: Prevent mislabeling of surgical specimens, implants, and biopsies, which can lead to diagnostic errors or inappropriate treatment.
Key Elements:
Label at the Point of Collection: In the OR, label specimen containers at the bedside immediately after collection.
Include Two Identifiers & Site: Labels must list patient name, medical record number, date/time, and specimen source (e.g., “Left breast mass”).
Verification by Two Team Members: Ideally, the nurse and surgeon verify labels together.
Evidence & Best Practices:The College of American Pathologists has guidelines showing that proper labeling reduces specimen identification errors by more than 90% Joint Commission.
Communication: The Glue That Holds Protocols Together
Universal Protocol steps rely on effective communication among caregivers, and with patients:
Briefings & Debriefings: Quick team huddles to review patient history, allergies, and anticipated challenges.
Closed‑Loop Communication: When instructions are given, the recipient repeats them back to ensure accurate receipt.
Patient Involvement: Engaging patients in confirming their identity, procedure, and site (e.g., “Is this left knee for your arthroscopy?”).
Evidence & Best Practices:The WHO Surgical Safety Checklist, which incorporates Universal Protocol principles, improved overall surgical mortality by 23% in a global study of 8,000 patients
When Universal Protocol Breaks Down: Malpractice & Settlements
Case 1: Wrong‑Site Amputation
In Smith v. Regional Medical Center, a healthy left toe was amputated instead of the diseased right toe. The hospital conceded that site marking and time‑out procedures were not performed consistently. The plaintiff received a $4.2 million settlement.
Case 2: Wrong‑Patient Surgery (Bawa‑Garba Case)
While outside the U.S., the UK’s Hadiza Bawa‑Garba case underscores the impact of wrong‑patient errors: a pediatrician restarted CPR on the wrong child after misreading notes in a side‑room. Though not a settlement, the event led to her criminal prosecution and fueled policy changes to strengthen Universal Protocol compliance
Case 3: Mislabeling Specimens
In Jones v. University Hospital, a breast biopsy specimen was mislabeled as belonging to another patient. The error delayed cancer diagnosis by six months, resulting in a $2.8 million award.
These sentinel events are a reminder: omission of Universal Protocol steps can have monumental human and financial costs.
EvaluCare: Your Partner in Patient Safety as a Medical Care Review Resource for Medical Errors & Malpractice Review
When a Universal Protocol lapse leads to harm, patients and families need clarity and expert guidance. EvaluCare provides:
Comprehensive Record Reviews: Verifying compliance with pre‑procedure checks, site marking, and time‑out documentation.
Clinical & Quality Expertise: Engaging seasoned surgeons, nurses, and risk managers to assess protocol adherence.
Objective Reports: Detailed findings that can support medical malpractice claims or drive institutional improvements.
If you or a loved one suffered due to a wrong‑site, wrong‑procedure, or wrong‑person error, EvaluCare’s team can help uncover what went wrong—and how to prevent it for others.
Learn more:
Learn more at www.EvaluCare.net EvaluCare Medical Care Review Services or email info@EvaluCare.net
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Evidence‑Based References
The Joint Commission. Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery. Joint Commission
The Joint Commission. National Patient Safety Goals, January 2024. Joint Commission
Haynes AB, et al. A Surgical Safety Checklist to Reduce Morbidity and Mortality in a Global Population. N Engl J Med. 2009;360(5):491–499.
Clarke JR, Sevdalis N, et al. Wrong‐site surgery: a human factors root cause analysis. Surgery. 2007;142(5):609–615.
Kohn LT, Corrigan JM, Donaldson MS, editors. To Err Is Human: Building a Safer Health System. Institute of Medicine; 2000.
World Health Organization: Surgical Safety Checklist Implementation Manual. WHO; 2008.
Arriaga AF, et al. “Simulation‐based trial of surgical‐crisis checklists.” N Engl J Med. 2013;368(3):246–253. Demonstrated that use of checklists, including Universal Protocol elements, halved the rate of major errors in simulated crises.
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