AAOS Bulletin - February, 2005

Patient safety in office-based surgery

New preoperative and postoperative checklists available

By David A. Wong, MD, and Steven S. Fountain, MD

Today, about 70 percent of surgeries are performed in outpatient settings, including physician offices. But even though as many as 1.2 million office-based procedures are performed each year, only 10 states have regulations governing these procedures.

States that provide oversight for office-based surgery (OBS) have generally taken one of two approaches. One option is to regulate OBS through statutes or regulations that have the force of law.

Noncompliance may be punishable by disciplinary proceedings against a health care professional’s license. Another option is to issue voluntary guidelines or position statements based on the recommendations of a task force or study committee. Although these guidelines or statements are not intended to result in licensure discipline, they may be used to establish the standard of care in medical liability actions.

States may apply different regulations to physicians’ offices depending on the magnitude of the procedure (e.g. minor) and the level of analgesia/anesthesia. As with all state regulations, the exact application of the rules depends on the specific language. The agency responsible for enforcing the rules, usually the state medical board, will generally respond to individual inquiries. Other sources for information include state and national specialty societies, state medical societies and national accrediting bodies.

The number of office-based surgeries will likely continue to increase, as will public scrutiny and a patchwork of regulations. New data on patient safety and technological advances will force states to consider more regulation.

The surgeon’s responsibilities

A patient scheduled for 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. This is a misperception that neither the patient nor the surgeon should have. A surgeon who performs an 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.

Orthopaedic surgeons who perform OBS can improve patient safety by addressing the following 11 issues:

1. Facility accreditation

2. Physician training and competency

3. Patient selection

4. Informed consent criteria

5. Anesthesia guidelines

6. General recommendations for preventing drug name mix-up

7. Facility maintenance

8. Training in emergency procedures and resuscitative techniques

9. Emergency transfer protocols

10. Reporting adverse events

11. Disclosure of adverse outcomes

Facility accreditation

Whether accreditation is required for OBS or not, the quality of surgical services should meet nationally established standards. For example, there should be written policies and procedures covering governance and ensuring compliance with local, state and federal regulations. The health care practitioners should be licensed or certified, and qualified to perform services consistent with their education, training and experience. Credentialing should be established by written policy.

In addition, the organization should have a quality assurance program that strives for continuous quality improvement and risk management. It should maintain legible, complete medical records for each patient and have policies that address retention, storage and privacy of the records. Finally, the facility should comply with all governmental laws, codes and regulations, including those pertaining to construction, occupancy, fire safety, accommodations for the disabled, OSHA and disposal of medical and hazardous waste.

Physician competency

As mentioned above, surgeons should be board-certified or board-eligible and perform only procedures that are within their scope of training and practice. Surgeons should maintain core privileges at an accredited hospital or ASC for the procedures they perform in the office.

Patient selection

Patients selected for OBS should meet specific criteria to ensure their safety and maximize the potential for a satisfactory outcome. Criteria should include the American Society of Anesthesiologists’ (ASA) Physical Status Classification System and the levels of sedation or anesthesia required by the procedure.

Patients should have a history and physical examination appropriate to the procedure and level of analgesia/anesthesia, and clearance by the primary care physician as well as appropriate laboratory and cardiopulmonary tests.

OBS on pediatric patients requires appropriate personnel, equipment and medication for infants and children. The American Academy of Pediatrics has a policy statement on monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures, available at http://aappolicy.aappublications.org/cgi/reprint/pediatrics;89/6/1110

Informed consent criteria

Standard informed consent criteria should be met, including discussion and documentation of the risks, complications, benefits and alternative treatments; the nature and objectives of planned anesthesia and surgery; and the discharge process and postsurgical care. The patient should be given a 24-hour telephone number for questions.

Sedation guidelines

The level of anesthesia should be appropriate for the patient, surgical procedure, clinical setting, education and training of personnel and the equipment available. Those who administer anesthesia should be licensed, qualified and working within their scope of practice, and physically present during and after the procedure, and until the patient is discharged from anesthesia care. Additionally, each patient should be assigned to an ASA Physical Status Classification System category, and intra-operative monitoring—appropriate to the patient and type of anesthesia—should be used. A reliable source of oxygen, suction, resuscitative equipment and emergency drugs should be immediately available.

Preventing drug name mix-up

A common system failure is confusing drug names leading to potentially harmful medication errors. Orthopaedic surgeons need to take steps to prevent drug name mix-ups in office-based surgery. These measures include: maintaining awareness of look-alike and sound-alike drug names as published by various safety agencies (e.g. epinephrine and ephedrine, fentanyl and sufentanil, hydromorphine and morphine); encouraging read back and spelling of the product name and its indication when using telephone/verbal orders; and encouraging patients to question medications that are unfamiliar, or look or sound different than expected.

Facility maintenance

The facility should be properly maintained with an antiseptic environment, sterile supplies and back-up power sufficient to ensure patient safety. All equipment appropriate to the procedure should be maintained, tested and inspected to the manufacturer’s recommendations.

Trained personnel

Written protocols should be developed for cardiopulmonary emergencies and other internal/external disasters, and all facility personnel should be trained in these protocols. Consider having at least one physician credentialed in advanced resuscitation and appropriate resuscitative equipment on site. Office personnel with direct patient contact should be trained in Basic Life Support. Written protocols, medications and equipment should be immediately available to treat malignant hyperthermia when triggering agents are used.

Emergency transfer protocols

Physicians who perform OBS should develop a written protocol for the safe and timely transfer of patients to a pre-specified alternate care facility when extended or emergency services are needed for the patient’s health and safety. Protocols must include either a written transfer agreement with a nearby hospital, or all surgeons at the OBS facility should have admitting privileges at the hospital. Local ambulance or emergency response teams must respond in a timely manner.

Reporting adverse events

The reporting of certain unexpected adverse events will improve the safety of patients who are treated in an OBS. Patient safety reporting systems often include the documenting/reporting of: patient death within 30 days of a procedure; unscheduled transport of patients to a hospital for observation or treatment for a period in excess of 24 hours; unscheduled hospital admission of patients within 72 hours of discharge from an OBS; and wound infection.

Disclosure of adverse outcomes

Although errors are unexpected, adverse clinical events are a difficult part of medical practice. They do not necessarily warrant a claim or litigation. Once it is clear that a complication or adverse event has occurred, the physician should promptly communicate this with the patient, the family or a significant other. The physician should understand that acknowledging the occurrence of an adverse event is not the same as admitting liability.

A sincere expression of empathy will convey to the patient that you care about what has happened. Explain all the facts. Do not delay in discussing an adverse event. Delays increase the difficulty of explaining the circumstances in a way that patients can accept, and contribute to feelings of distress, blame and anger. Be straightforward, telling the patient what you know without attributing blame or guilt. Be honest, even if you must say, “I don’t know” or “I don’t know yet.” Reassure the patient that you will share information as you learn it.

Patient safety checklists

The AAOS is dedicated to improving patient safety by implementing programs to ensure that patient safety is a cornerstone of orthopaedic practice. To assist physicians’ efforts to improve patient safety in the practitioner’s office, the AAOS has developed both preoperative and postoperative patient safety checklists for office-based surgery. These checklists are best clipped directly to the patient chart, and completed and signed by the orthopaedic surgeon.

The preoperative checklist ensures that the surgeon has considered issues related to the patient’s safety for the specific procedure and that certain safety-related processes have been performed prior to surgery. The postoperative checklist ensures that the surgeon considers issues related to the patient’s safety at discharge. These checklists can be downloaded from the patient safety section of the AAOS Web site: http://www.patientsafety.aaos.org/

David A. Wong, MD, is chair of the AAOS Patient Safety Committee. He can be reached at ddaw@denverspine.com

Steven S. Fountain, MD, chaired the task force on Office-Based Surgeries and currently serves as a member of the AAOS Patient Safety Committee. He can be reached at sfountain@norcalmutual.com

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