practice of Medicine
Orthopedic Surgery Toolkit
Failure to conduct pre-procedure verification has been cited as a root cause of serious surgical adverse events. The Joint Commission (TJC) has emphasized this important process as one of its National Patient Safety Goals.
TJC has published the Universal Protocol for preventing wrong site, wrong procedure, and wrong person surgery™ which we outline in this Advisory.
Verify the correct procedure, for the correct patient, at the correct site.
- When possible, involve the patient in the verification process.
- Identify the items that must be available for the procedure.
- Use a standardized list to verify the availability of items for the procedure. (It is not necessary to document that the list was used for each patient.) At a minimum, these items include:
- Relevant documentation:Examples: history and physical, signed consent form(s), pre-anesthesia assessment
- Labeled diagnostic and radiology test results that are properly displayed:Examples: radiology images and scans, pathology reports, biopsy reports
- Any required blood products, implants, devices, special equipment
- Match and then double check each of the items that are to be available in the procedure area to the patient.
Mark the procedure site
The site does not need to be marked for bilateral structures.
Examples: tonsils, ovaries
For spinal procedures: Mark the general spinal region on the skin. Special intra-operative imaging techniques may be used to locate and mark the exact vertebral level.
Mark the site before the procedure is commenced.
If possible, involve the patient in the site marking process.
The site is marked by a licensed independent practitioner who is ultimately accountable for the procedure, and will be present when the procedure is performed.
Ultimately, the licensed independent practitioner is accountable for the procedure – even when delegating site marking.
- The mark should be unambiguous and used consistently throughout the organization.
- The mark is made at or near the procedure site.
- The mark shall be sufficiently permanent to be visible after skin preparation and draping.
- Adhesive markers are not the sole means of marking the site.
- For patients who refuse site marking or when it is technically or anatomically impossible or impractical to mark the site, use your organization’s written, alternative process to ensure that the correct site is operated on.
Perform a time-out
Conduct a time-out immediately before starting the invasive procedure or making the incision.
- A designated member of the team starts the time-out.
- The time-out is standardized.
- The time-out involves all of the immediate members of the procedure team: the individual performing the procedure, anesthesia providers, circulating nurse, operating room technician, and others who are participating in the procedure from the beginning.
- All relevant members of the procedure team actively communicate during the time-out.
- During the time-out, the team members agree, at a minimum, on (1) correct patient identity; (2) correct site; and (3) procedure to be performed.
- When the same patient has two or more procedures, another time-out needs to be performed before starting each procedure.
- Document the completion of the time-out. The organization determines the amount and type of documentation.
Address missing information or discrepancies before starting the procedure. At a minimum, mark the site when there is more than one possible location for the procedure and when performing the procedure in a different location could harm the patient. The procedure is not started until all questions or concerns are resolved.
Ultimately, it is up to each organization to decide when this pre-procedure information is collected and by which team member. It is always best to involve the patient directly in the process.
MagMutual Risk Management and Patient Safety Consultants invite our policyholders’ questions. If you wish to discuss issues related to this article, or have other questions please call us at 1-800-282-4882, and ask for Risk Management.
This document has been adapted with TJC’s permission from the full Universal Protocol. For specific requirements of the Universal Protocol see The Joint Commission standards.
Recruit claims her military career cut short by wrong-site surgery
This patient injured her back during training. Thereafter, she was unable to perform all of her job duties. She was referred to an orthopedic surgeon who performed a L4-5 laminotomy and diskectomy due to disk herniation. Although the surgeon had been hesitant to perform the diskectomy, the patient was adamant that she did not want fusion surgery, as she felt it would end her military career.
Despite therapy, exercise, and epidural injections, the patient continued to have moderate back pain and sciatica. She returned to the surgeon eight months later. The surgeon explained that she was a candidate for spinal fusion or artificial disk replacement surgery. A repeat MRI did not show a recurrent disk herniation which meant that diskogenic pain was the most likely diagnosis. The surgeon explained that the failure rate for these operations is in the 20-25% range. The other risks of the surgery were explained in detail. The patient had done her own research, as well, and was ready to “participate in whatever was necessary”. The patient was primarily interested in disk replacement surgery.
The disk replacement procedure involved a two part procedure. The general surgeon nicked the patient’s vena cava during the anterior approach and the operative area had to be packed. When the orthopedic surgeon arrived in the operating room for the second part of the procedure, he took radiographic localization to confirm they were at the L4-5 level. But, shortly thereafter, he determined that he was at L5-S1, the wrong level. He stopped the procedure and tried to mobilize the vessels to get exposure to L4-5. This was not possible because the bifurcation of the iliac vein was just inferior to the L4-5 level. The bifurcation is usually just above the area. Initially, they were going to attempt disk replacement at both levels, but once they realized they could not make an anterior approach to L4-5, the orthopedic surgeon elected to perform an anterior lumbar interbody fusion at L5-S1. The patient was subsequently discharged from the military with a 20% medical impairment, but continued to work. She complained of chronic pain and limited mobility.
In her lawsuit against the orthopedic surgeon, the plaintiff alleged that the orthopedic surgeon failed to perform a disk replacement at L4-5 for which she had given informed consent, negligently failed to obtain informed consent for disk removal at L5-S1, negligently failed to identify the location of L4-5, and negligently removed the L5-S1 disk. As a result, the plaintiff alleged that she had suffered a permanent back injury and interference with her ability to move and ambulate. She contended that her back condition was made worse. The lawsuit was settled for a moderate amount of money.
Risk Management Commentary:
How might this orthopedic surgeon have prevented the wrong-site surgery?
- The orthopedic surgeon testified that had he done fluoroscopy immediately prior to the operation at L5-S1, he probably would have realized he was at the wrong level.
- One of the defense experts indicted that disk replacement surgery was a fairly new procedure in the United States at the time it was performed on this patient. In order to do the disk replacement, he explained one must use an anterior approach. He stated that you are performing two operations: the exposure of the area by a vascular surgeon and then the actual orthopedic surgery at the disk space. This expert believed that a laminectomy would have been more effective and the surgeon would have been less likely to have operated at the wrong level.
“Wrong-site surgery is the sentinel event most frequently reported to The Joint Commission,” said Bradford Currier, M.D., Professor of Orthopedics at the Mayo Clinic in Rochester, Minnesota. during a presentation at the 2012 Cervical Spine Research Society Annual Meeting.[i]
According to Dr. Currier, “approximately 30 percent of wrong-site surgeries reported in Minnesota are wrong-level spine procedures“. Dr. Currier also stated that, “despite its frequency and substantial health and medico legal ramifications, wrong-site spine surgery (WSSS) is poorly defined and consequently has ambiguous and variable reporting requirements.”
There are several factors inherent to spine surgery that increase the risk of WSSS compared with other types of surgery. Not only can a surgeon potentially operate on the wrong side of the spine or the wrong level, but there are unique issues related to spinal localization that can be challenging for even the most experienced clinician. Strategies to avoid wrong-site spinal surgery are discussed in the article, Strategies to avoid wrong-site surgery during spinal procedures by Wesley Hsu, MD et al[ii]. The authors provide a detailed review of the following areas:
- Preoperative verification of surgery
- Intraoperative localization
- Localization in the Cervical Spine
- Localization in the Thoracic Spine
- Localization in the Lumbar Spine
- Prevention of WSSS using 3D Intraoperative Imaging
Wrong-site surgery should be viewed as a preventable complication. Verification of the intended surgical site preoperatively is critical; standardized checklists can help facilitate this process. Recognition of the unique challenges in spinal localization should be acknowledged and there are strategies discussed in the literature that are safe and easy to implement to help to ensure accurate intraoperative localization.
Managing office-based surgery emergencies
Prior to administering anesthesia in the office-based setting, anesthesia providers verify appropriate resources are available to manage an emergency situation. Providers are to ensure that a written protocol is in place that addresses medical emergencies, as well as internal and external disasters. Personnel are to be properly trained on steps to take during an emergent event. Regular review of the protocol and procedures for handling emergencies is recommended.
According to The American Society of Anesthesiologists (ASA) Guidelines for Office-Based Anesthesia1, the anesthesia provider in the office setting is to ensure measures are in place to manage emergency situations that may arise. These measures include:
- All facility personnel are appropriately trained and regularly review the facility’s written emergency protocols.
- There are written protocols for cardiopulmonary emergencies and other internal and external disasters such as fire.
- The facility has medications, equipment and written protocols available to treat malignant hyperthermia when triggering agents are used.
- The facility has a written protocol in place for the safe and timely transfer of patients to a pre-specified alternate care facility when extended, or emergency services are needed to protect health or well-being of the patient.
The American Association of Nurse Anesthetists (AANA) has developed minimum guidelines for providing anesthesia services in the office-based practice setting.2
These guidelines include the following available emergency equipment:
- Basic adult airway equipment, including pediatric, if necessary
- Nasal and oral airway
- Face mask (appropriate for patient)
- Laryngoscopes, endotracheal tubes (adult and pediatric)
- Ambu bag or other positive pressure ventilation device
- Difficult airway equipment (laryngeal mask airway, light wand, cricothyrotomy kit) Defibrillator
- Supplemental O2, emergency drugs, compression board, suction equipment (suction catheter, Yankaur type), drugs and equipment to treat malignant hyperthermia on site
- Back-up power
Errors in diagnosis
Failure to diagnose, a misdiagnosis or a delayed diagnosis are common allegations in a medical professional liability claim. In today’s litigious society, it is imperative that physicians become more aware of situations contributing to these types of allegations. The following are frequently found in cases alleging an error in diagnosis:
- Incomplete medical history.
- Inadequate inquiries regarding issues associated with a patient’s primary complaints and symptoms.
- Inadequate review of or failure to review the chart for information recorded by other healthcare workers.
- Inadequate physical examination and failure to record all positive and negative findings.
- Failure to recognize dangerous signs, symptoms or complaints such as:
- Abnormal bleeding
- Abdominal pain
- Chest pain
- Changes in neurovascular status
- Fever of unknown origin
- Unexplained weight changes
- Unexplained changes in mental status
- Failure to review laboratory and x-ray results.
- Failure to perform indicated or baseline studies.
- Failure to document rationale for ruling out a diagnosis of an acute condition.
- Failure to warn patients of the potential consequences of refusing diagnostic treatment.
- Failure to recommend follow-up care or hospital admission.
- Inadequate follow-up with patients who missed appointments for chronic or potentially serious conditions.
- Failure to communicate with the consulting or the referring physician.
A patient scheduled for office-based surgery (OBS) may believe that the procedure is minor, carries minimal or no risk, generally has a good outcome, and fixes the problem in a matter of minutes. Neither the patient nor the surgeon should have this misperception. A surgeon who performs OBS must manage all processes and implement all safeguards that are typically the responsibility of others in the ambulatory surgery center (ASC) or hospital operating room, in order to keep their patients safe and healthy.
Key areas of concern include:
- Failure to become accredited by the JCAHO, the American Association for Accreditation of Ambulatory Healthcare or the American Association for Accreditation of Ambulatory Surgical Facilities. Accreditation indicates that the facility at least meets minimum national standards for policies.
- Use of antiquated anesthesia equipment that may not meet the ASA (American Society of Anesthesiologists) basic standard for intraoperative monitoring.
- Failure to ensure routine preventive maintenance for all equipment.
- A pharmacy that may be inadequate to treat unexpected complications including cardiac arrhythmia and brochospasm.
- Absence of prearranged transfer protocols in the event that an emergency requires hospital admission.
- Inadequately trained personnel especially in the area of monitoring the sedated patient, airway management and resuscitation techniques.
- Polypharmacy (the simultaneous or sequential use of multiple pharmacological agents) is a common problem in prolonged procedures performed under “conscious sedation.” The additive or synergistic effects of multiple sedative/opioid drugs may result in lifethreatening respiratory depression. Additionally, polypharmacy may also lead to the inappropriate use of “reversal agents” which typically have a shorter pharmacological half-life than that of the depressant drug. When reversal agents are employed, the patient may return to a sedated state in an unmonitored environment.
- Inadequate skills in patient assessment for anesthesia.
- Failure to adhere to national standards, including the ASA’s “Guidelines for Office-Based Anesthesia,” the ASA “Statement on Qualification of Anesthesia Providers in the Office-Based Setting,” and the ASA “Standard for Basic Anesthetic Monitoring.”
- Lastly, and most importantly, good equipment and effective drugs are safe only in the hands of well-trained professional personnel. The surgeon operating in an office environment must recognize that he/she assumes multiple responsibilities that are assumed by the institution and/or the anesthesiology department in a hospital or ambulatory surgery center. Broadly, these responsibilities are to ensure that facilities, policies, procedures and personnel are adequate and appropriate for the type of surgery performed. In particular, absent an anesthesiologist, the supervising physician should be especially trained in sedation, anesthesia and rescue techniques appropriate to the type of sedation or anesthesia being provided.
Whenever patients have elective surgery and anesthesia, they should be afforded a level of safety equal to that in the hospital environment. Patients deserve no less, and we physicians must provide no less.
Risk Management Discussion Points for Office-Based Surgery
One of the biggest and most recent changes in healthcare environment with the advent of managed care has been the move of many surgical procedures out of the hospital and ambulatory surgical centers and into doctor’s offices. With this change, there are more physicians with little experience in handling powerful sedating drugs and little or no emergency equipment available to save patients who experience complications. There are only a few states that have addressed guidelines and requirements for the protection of the patient during in-office procedures.
Monitoring and Equipment Recommendations
While surgical procedures are increasingly being moved out of the hospital and ambulatory surgical centers and into doctor’s offices, there are no Federal requirements for the protection of the patient during in-office procedures. Only a few states have addressed this and implemented some requirements for office-based surgery. The American Society of Anesthesiologists (ASA) and The American College of Surgeons (ACS) have addressed this issue. The ASA has published Guidelines for Office-Based Anesthesia, and the ACS has published Guidelines for Optimal Office-Based Surgery. According to some of the ASA guidelines:
- All facilities should have, at a minimum, a reliable source of oxygen, suction and resuscitation equipment and emergency drugs. When using IV sedation, it is recommended that pulse oximetry be used.
- All equipment should be maintained, tested and inspected according to the manufacturer’s specifications.
- Backup power sufficient to ensure patient protection in the event of an emergency should be available.
Healthcare Professionals Involved in Monitoring and Treatment
It is extremely important for the facility to have written policies and procedures. These should include policies related to the credentialing of the personnel along with the procedures to be followed for monitoring patients during surgical intervention.
According to the ASA:
- All healthcare practitioners and nurses should hold a valid license or certificate to perform their assigned duties (a copy of the current license should be in their personnel file).
- All operating room personnel who provide clinical care in the office should perform services commensurate with their levels of education, training and experience.
Surgeon’s Responsibility and Liability/Anesthesiologist/Certified Nurse Anesthetists / Anesthesia PAs
According to the ASA Guidelines for Office-Based Settings, anesthesiologists should participate in all office-based surgery as an important anesthesia safety standard. The ASA also recommends that if the regulatory requirements do not specifically state that an anesthesiologist must be involved in the care of the patient, then the supervising physician should be specifically trained in sedation, anesthesia and rescue techniques appropriate to the type of sedation or anesthesia being provided and to the office-based surgery being performed.
Familiarity with the effects and contraindications of the pharmacological agents being used is very important.
The supervising physician must recognize that no matter whether there is an RN, an anesthesia PA or a CRNA administering and monitoring a patient’s sedation, they are all performing a delegated medical function under the direct supervisory responsibility of the physician. The ACS’ Optimal Guidelines for Office-Based Surgery states that general or spinal anesthesia must be supervised by a board-certified anesthesiologist, a physician eligible to take the anesthesiology board examination or a registered CRNA under physician supervision.
It is recommended that physicians who use the services of CRNAs should require the CRNA to have an ongoing quality assurance relationship with an anesthesiologist to provide regular review of their anesthesia practices.
Response to Emergencies
All facilities that are performing office-based surgery should have written policies and procedures for all emergencies including cardiopulmonary emergencies and other internal or external disasters such as fire. All surgical personnel must be trained in basic life support (CPR) and must be recertified as required.
There should be a cardiopulmonary resuscitative cart available for emergencies, and at a minimum it should include an Ambu bag, a laryngoscope and a medication kit. The medication kit should include appropriate medications for treatment of anaphylaxis, cardiac arrhythmias and CPR.
Both the ASA and ACS recommend that every facility have written protocol for on-site recovery, arrangements for safe and timely transfer of patients to a prearranged acute care hospital when extended or emergency services are needed to protect the health of the patient and for patient discharge home.
When a patient is discharged home after a procedure, it is the responsibility of the physician to make sure the patient is recovered sufficiently to function independently. The patient should have stable vital signs and be fully oriented and able to move all extremities. When any type of sedation has been used, the patient should have a responsible adult take him/her home. Discharge instructions should be given verbally and in writing.
While only a few states have imposed regulations and guidelines for office-based surgery, the American Society of Anesthesiologists, the American College of Surgeons and other organizations that are involved with outpatient surgery are excellent resources. With so many bad outcomes being reported by the press lately, coupled with MAG Mutual’s experiences, we feel office-based surgery safety is something that needs to be brought to the attention of all physicians performing surgery in the office environment.
American Society of Plastic Surgery (ASPS), R. Iverson, MD and the ASPS Task Force on Patient Safety in Office-based Surgery Facilities, http://www.plasticsurgery.org/Documents/medical-professionals/health-policy/key-issues/Procedures-in-the-Office-based-Surgery-Setting.pdf Accessed October 2012
American Academy of Orthopedic Surgeons (AAOS); D. Wong, MD, S. Fountain, MD; Patient Safety in Office-Base Surgery. http://www2.aaos.org/bulletin/feb05/fline1.asp
American Society of Anesthesiologists, Publications, https://ecommerce.asahq.org/default.aspx?
American Society of Anesthesiologists, Guidelines for Office-Based Anesthesia, http://www.asahq.org/for-members/advocacy/state-legislative-and-regulatory-issues/office-based-surgery.aspx
The information provided in this resource does not constitute legal, medical or any other professional advice, nor does it establish a standard of care. This resource has been created as an aid to you in your practice. The ultimate decision on how to use the information provided rests solely with you, the PolicyOwner.