Wrong-site surgery (WSS), encompasses surgery performed on the wrong side or site of the body, wrong surgical procedure performed, and surgery performed on the wrong patient.
It includes invasive procedures that exposes patients to more than minimal risk, including procedures performed in settings other than the OR, such as a special procedures unit, an endoscopy unit, and an interventional radiology suite.
It is also defined as a sentinel event, an unexpected occurrence involving death or serious physical or psychological injures, or the risk thereof) by the Joint Commission.
State licensure boards are imposing penalties on surgeons for WSS,
Some insurers have decided to no longer pay providers for WSS or wrong-person surgery, nor for leaving a foreign object in a patient’s body after surgery.
Surgery performed on the wrong site or wrong person has also often been compensable under malpractice claims.
Indeed, 79 percent of wrong-site eye surgery and 84 percent of wrong-site orthopedic claims resulted in malpractice awards.
It could be that only 10 percent of actual WSSs are reported.
Joint Commission’s numbers are low, finding wide variations in the number of WSSs: 1 out of 27,686 cases, or 1 out of every 112,994 surgeries, or 1 in 5 hand surgeons during their career, or 1 out of 4 orthopedic surgeons with 25 years’ experience.
They are preventable medical error if certain steps are taken and standardized procedures are implemented in the perioperative setting.
Most WSSs occur most commonly in orthopedic or podiatric procedures, general surgery, and urological and neurosurgical procedures.
National Patient Safety Goals to target wrong-site surgery:
Goal 1—to improve the accuracy of patient identification by using two patient identifiers and a “time-out” procedure before invasive procedures.
Goal 2–to eliminate wrong-site, wrong-patient, and wrong-procedure surgery using a preoperative verification process to confirm documents, and to implement a process to mark the surgical site and involve the patient/family.
Its generally caused by a lack of a system to verify the site of surgery or a breakdown of the system that verifies the correct site of surgery.
Joint Commission found the top root causes of WSS to be communication failure, 70 percent of the time, procedural noncompliance, 64 percent, and leadership 46 percent.
Risk factors associated with WSS: emergency cases, multiple surgeons, multiple procedures, obesity, deformities, time pressures, unusual equipment or setup, and room changes.
Process Factors include:
Lack of institutional controls/formal system to verify the correct site of surgery
Lack of a checklist to make sure every check was performed
Exclusion of certain surgical team members
Reliance solely on the surgeon for determining the correct surgical site
Unusual time pressures
Pressure to reduce preoperative preparation time
Procedures requiring unusual equipment or patient positioning
Patient characteristics, such as obesity or unusual anatomy, that require alterations in the usual positioning of the patient
Inadequate patient assessment
Inadequate care planning
Inadequate medical record review
Miscommunication among members of the surgical team and the patient
More than one surgeon involved in the procedure
Multiple procedures on multiple parts of a patient performed during a single operation.
Failure to include the patient and family or significant others when identifying the correct site.
Failure to mark or clearly mark the correct operation site
Incomplete or inaccurate communication among members of the surgical team
Noncompliance with procedures
Failure to recheck patient information before starting the operation
Protocols to prevent wrong surgical site procedures call for ”sign your site” programs calling for marking the exact site with a radiopaque indicator, and put forth a checklist for patient and procedure verification.
A requirement for site marking should focus on cases involving right/left distinction, multiple structures such as fingers, toes. or levels such as the spine.
Adding an additional warning such as “No” on the incorrect site and having the surgical team work together to verify the correct site helped the Sign Your Site program to be effective.
Such protocols should be used in ambulatory care, hospitals, critical access hospitals, and office-based settings.
Adherence to such protocols should eliminate WSS errors that can be attributable to interruptions, distractions, and too many forms or procedures.
These protocol elements are included in the accreditation process for health care organizations.
The goal of preventing wrong site, wrong procedure, wrong person surgery can and should be achieved.
Preoperative verification of all of the relevant documents and studies are available prior to the start of the procedure.
Preoperative verification process includes verification of the correct person, procedure, and site should occur.
The time the surgery/procedure is scheduled.
At the time of admission or entry into the facility.
Before the patient leaves the preoperative area or enters the procedure/surgical room.
A preoperative verification checklist to review:
Relevant documentation such as history and physical, consent form, relevant imaging, required implants and special equipment, marking the operative site unambiguously,, the mark must be positioned to be visible after the patient is prepped and draped, the marker must remain visible after completion of the skin prep, adhesive site markers should not be used as the sole means of marking the site.
Mark all cases involving laterality, multiple structures such as fingers, toes, lesions, multiple levels.
The person performing the procedure should do the site marking, with the patient involved, awake, and aware, if possible.
Final verification of the site mark must take place during the “time out.”
Time out includes:
Correct patient identity.
Correct side and site.
Agreement on the procedure to be done.
Correct patient position.
Availability of correct implants and any special equipment or special requirements
When a practitioner erroneously performs a particular surgical or other invasive procedure intended for a different patient on a Medicare beneficiary who does not need that procedure, Medicare will not cover that particular surgical or other invasive procedure.
A surgical procedure is considered to have been performed on the wrong patient if that procedure is not consistent with the correctly documented informed consent for that patient.
Surgical and other invasive procedures are defined as procedures in which skin or mucous membranes and connective tissue are incised or an instrument is introduced through a natural body orifice.
Invasive procedures include: minimally invasive dermatological procedures to extensive multi-organ transplantation.
All procedures described by the codes in the surgery section of the Current Procedural Terminology (CPT) and other invasive procedures such as percutaneous transluminal angioplasty and cardiac catheterization are included.
Minimally invasive procedures involving biopsies or placement of probes or catheters requiring the entry into a body cavity through a needle or trocar, are also included.
The Centers for Medicare and Medicaid Services (CMS) has determined that when a healthcare professional erroneously performs a surgical or other invasive procedure that was intended for a different patient on a Medicare beneficiary who does not need that procedure, it will not cover that particular surgical or other invasive procedure because it is not a reasonable and necessary treatment for the Medicare beneficiary’s medical condition.
An incorrect informed consent that is not accurate is considered performing a surgical procedure on the wrong patient.
Adverse events that are serious, largely preventable and of concern to both the public and health care providers: known as “never events.”
Among surgical events on the never events list is surgical procedures performed on the wrong patient.
It is unnecessary to determine that performing a surgical or invasive procedure on the wrong patient will not improve health outcomes but harms the patient.
A 2006 study reviewing 10 years of 2.8 million procedures, reported an incidence of 1 in 112994 operations of non-spine wrong site operations (Kwaan).
The incidence of wrong site surgery is not known, but might be expected to occur once each year in a 300-bed hospital and surgeons who work on symmetrical structures may have a 1 in 4 chance to be involved in a wrong-site error during their careers (Clarke et al.).
The definition of wrong surgery is appropriately based upon informed consent, which should be accurately completed before surgery.
Informed consent should include possible procedures that can be foreseen.
Evidence of harm or lack of of benefit is not necessary to determine that a surgical procedure on the wrong patient does not improve health care outcomes.