What can be done to boost surgery safety in offices?
While a recently published review of Florida surgeries said that death or injury is 10 times more likely in the physician office setting,1 another recently published report indicates a high level of safety in physician offices, at least with oral and maxillofacial procedures.2 (For more information on the Florida study, see Same-Day Surgery, October 2003, "Analysis examines surgery in physician offices," p. 119.)
Of 34,000 patients who received office-based anesthesia for oral and maxillofacial procedures between January 2001 and December 2001, there were 24,000 patients who received deep sedation or general anesthesia. A surgeon aided by two to three anesthesia assistants, rather than an anesthesiologist, provided anesthesia services for 96% of the patients. Complications were experienced by 13 patients per 1,000 who received deep sedation/ general anesthesia. According to the authors, these were minor side effects, such as nausea, that often are associated with anesthesia.
The bottom line, however, is that all same-day surgery programs, whether in an office, surgery center, or hospital, want to reduce the risk of injuries and deaths. Consider these suggestions:
• Become accredited.
Fewer than 10% of physicians offices are accredited by accrediting bodies, estimates Michael Kulczycki, executive director of the Ambulatory Care Accreditation Program at the Joint Commission on Accreditation of Healthcare Organizations.
The Florida study said that less than half of office-based practices in that state were accredited.
However, under state regulatory reform of office surgery oversight, that number has now risen to almost 90%, says Maureen Doherty, spokeswoman for the Tallahassee-based Florida Board of Medicine. Under new state regulations, the number of deaths has dropped from 13 in a two-year period (April 1, 2000, to April 1, 2002) to three in the past year, Doherty says. Also, the number of injuries has decreased from 93 in the two-year period to 18 in the past year, she says.
The regulatory changes include a rule, implemented in 2002, that anesthesia must be administered by an MD or DO, not a nurse anesthetist or other provider. Also, office-based practices must be inspected and accredited by a national organization, and they face training and risk management requirements.
• Define the scope of your practice, and be prepared for the unexpected.
One of the critical elements of safe office-based practice is selecting the right patient for that setting, says David Shapiro, MD, president of the Johnson City, TN-based American Association of Ambulatory Surgery Centers and senior vice president of medical affairs for Surgis, a Nashville, TN-based company that owns and manages ambulatory surgery centers with physicians and hospitals. "That includes the surgeons selecting patients for procedures and making sure the patients are suitable and at a low risk of complications," he says.
Also, a "safety net" of an adequate number of competent and trained ancillary staff and an appropriately equipped facility is critical, he adds.
Referring to the deaths and injuries reported in the Florida study, Shapiro says, "I don’t think anything intentionally was done to put patients in harm’s way, but from hearing about cases and learning about them through the board of medicine hearings, it was a combination of a lack of real preparation to anticipate and treat any complications arriving from the procedure."
Staff coordination is a key step, he says. "From the preadmission staff to the circulating staff to the recovery area, when that team is working together, that safety net is there for that patient," Shapiro says.
In such an environment, complications can be avoided, or at least recognized, he says. "It requires constant vigilance and constant contact, and that was lacking in some offices [in the Florida study]."
• Provide the same level of care, regardless of setting.
Shapiro and other leaders in outpatient surgery maintain that the patient should receive the same level of care whether he or she is in an office, surgery center, or hospital.
"If you adhere to good medical practices and all the ancillary issues, such as personnel and equipment and precautions, then the patient should be able to get good care in any setting," Shapiro says.
Instead of rewriting state regulations for office-based practices, states should hold practices to the same level of care as surgery centers and hospitals, he says. In the meantime, states do continue to boost their regulation of office-based practices.
Twenty-two states have laws or regulations covering office surgery, according to the Florida study. Many limit the length of surgery or the number of procedures that can be done on a patient at one time.
Six more states are reviewing proposed regulations and may implement new ones in the next six months, Kulczycki says. They are Alabama, Arkansas, Arizona, Georgia, Tennessee, and Washington, he adds.
"One element may be requiring Joint Commission accreditation or accepting that accreditation in lieu of another inspection by the state, Kulczycki says. [For more on safety in physician offices, see Same-Day Surgery, November 2000, "Number of office-based surgeries rivals surgery centers; are they safe?" p. 133, "What led Florida board to pass moratorium?" p. 137, and SDS, December 1999, p. 137, "Long arm of regulation reaches out from states and anesthesia society."]
1. Vila H, Soto R, Cantor AB et al. Comparative outcomes analysis of procedures performed in physician offices and ambulatory surgery center. Arch Surg 2003; 138:991-995.
2. Perrott DH, Yuen JP, Andresen RV. Office-based ambulatory anesthesia: Outcomes of clinical practice of oral and maxillofacial surgeons. J Oral Maxillofac Surg 2003; 61:983-995.
For more information, contact:
- Michael Kulczycki, Executive Director, Ambulatory Care Accreditation Program, Joint Commission on Accreditation of Healthcare Organizations, Oakbrook Terrace, IL. E-mail: email@example.com.
- David Shapiro, MD, Surgis, 30 Burton Hills Blvd., Suite 450, Nashville, TN 37215. Tele-phone: (615) 665-3012.