May 1, 2013
Volume 77, Number 5
Safety Update: Office-Based Surgery
Fred E. Shapiro, D.O Committee on Patient Safety and Education
Richard D. Urman, M.D., M.B.A., CPE
As a greater number of procedures continue to migrate to the outpatient sector, the complexity of office-based surgery and anesthesia, along with patient population, will increase commensurately. Furthermore, management challenges will be complicated by an aging population with chronic medical conditions. The capacity constraints at office-based practices imply that such facilities may not have the necessary preparation available to handle difficult procedures and patients.
There is an added issue of so-called “practice drift.” This is when clinicians who are board-certified in one specialty attend weekend seminars and training sessions so they can render services out of the scope of their specialty. These medical practitioners who perform office procedures would traditionally not be granted privileges to perform those same procedures in the hospital, especially if they are operating outside their specialty training. Although a hospital-based facility might not acknowledge such credentials, providers are able to practice beyond their scope in private offices. The divergence in credentialing requirements between hospital and ambulatory institutions continues to create uncertainty in the quality of care at office-based settings.
The lack of standardized “best practices” in office procedural and anesthesia workflow constitutes a system defect that makes medical offices vulnerable when dealing with complex patients and procedures. This has led to many adverse events for patients, including deaths. Numerous high-profile incidents have caused states to impose a moratorium on office-based surgery and anesthesia.
A rapid shift toward a more outpatient-driven health care delivery system creates safety risks and potential quality lapses for patient care. Government regulation has not kept up with the rapid growth to address these divergences in quality at office sites. Medical offices are rife with unstandardized procedural and sedative practices, yet the scope of regulation of these private suites is not consistent with those standards maintained in hospitals or ambulatory surgery centers (ASCs). The regulation of medical office suites is under local and state purview as there is no uniform federal oversight of medical office suites. To compound the problem, regulation by state and local entities remains inconsistent. To date, only 28 states have office-based regulations and 27 states recognize or require accreditation of office procedures, according to the latest data from the Accreditation Association for Ambulatory Health Care (AAAHC).
The most recent development to address the issue of office-based facility oversight just occurred in Massachusetts. In January 2013, the Massachusetts State Legislature introduced bill #1942 in an attempt to add oversight to office-based surgery. This bill proposes mandatory accreditation of facilities performing moderate, deep sedation and/or general anesthesia by a nationally recognized accreditation agency beginning in 2014. Interestingly, this legislature was prompted by recent drug contamination by a compounding pharmacy in Massachusetts resulting in many patient deaths around the country, which made national headlines. The state legislature was alerted to the fact that office-based facilities were in need of heightened scrutiny.
At the same time, the Massachusetts Medical Society attempted to take the first step by adopting a non-binding set of guidelines for maintaining a safe, sterile environment in office-based facilities. These new developments demonstrate how the combination of state legislatures, medical boards and state medical societies can collaborate together to create a safer environment.
A July 2012 report from the United States Government Accountability Office (GAO) highlighted the lack of data on the extent and cost of blood-borne pathogen outbreaks related to unsafe injection practices in ambulatory care settings. This report was prompted by recent outbreaks of hepatitis B and C, such as incidents in Nevada in 2008, New Jersey in 2009, and most recently the 2012 outbreak of spinal meningitis around the country due to contaminated drugs. The report also highlighted the fact that while ACS facilities are subject to Centers for Medicare & Medicaid (CMS) oversight and its health and safety standards, some ambulatory facilities such as office-based practices may not be under CMS purview and therefore are not subject to on-site surveys by the major accrediting agencies such as The Joint Commission, AAAHC and the American Association for Accreditation of Ambulatory Surgery Facilities. Therefore, it remains up to the individual states to provide oversight of these office-based facilities. This recent GAO report highlights potentially profound public health consequences of failing to ensure proper oversight and emphasizes the need for developing tighter regulation of office-based facilities that do not meet the ACS definition.
Infection control is becoming increasingly important to ambulatory facilities ever since the implementation of new CMS standards in the 2009 Conditions for Coverage. CMS will be inspecting ASC facilities to ensure that each has an infection control program and that there is a designated qualified professional with infection control training in charge of the facility’s infection control program. It is possible that in the case of office-based facilities, accrediting agencies will play a bigger role in maintaining contamination-free environment.
The fact remains that office-based facilities may not be subject to CMS oversight, do not participate in the Medicare program as do many ACS facilities and therefore do not receive ASC Medicare facility payments. One recent development in the state of New York was the passage of bills regarding reimbursement for a facility fee from insurance companies for office-based surgery. The final outcome of this proposed legislature is likely to be determined this year in the New York Assembly.
In Florida, home to some of the earliest legislation regulating office-based surgery, legislation has been proposed requiring logs to be maintained that document the removal of more than 1,000cc of supernatant fat during liposuction procedures. Facilities in which more than 1,000cc of supernatant fat is removed in liposuction procedures will also be required to register with the Florida Department of Health.
New Jersey is considering similar legislation to limit settings where certain surgeries may be performed. Specifically, it will require accreditation by the AAAHC of any office or facility that performs the following: a liposuction procedure that involves removal of greater than 400cc of fat, a procedure that utilizes breast prosthesis, an aesthetic truncal contouring procedure that involves the non-lesional excision of skin.
In January 2012, CMS mandated utiliza-tion of a surgical safety checklist in all ASC facilities. Although there is no punitive action for noncompliance at this point beyond public reporting, it is a plausible mechanism for adding oversight. Despite the lack of mandate for checklist use in the office, a precedent has been set by CMS in other ambulatory settings. In fact, there is significant evidence from checklist research that these checklists can improve patient mortality and morbidity, can decrease costs and improve the health care team’s ability to respond to crisis situations. Although most evidence about the effectiveness of checklists comes from operating room settings in tertiary care inpatient facilities, there is a clear need to expand their use to outside of the O.R. and ambulatory facilities for use by both surgeons and interventionalists. The Institute for Safety in Office-Based Surgery (ISOBS) has developed a template safety checklist to be adapted by office-based practitioners that fits their specific practice needs. In addition, ISOBS has developed a patient’s safety checklist that is specifically intended for use by patients prior to undergoing a procedure in the office.
In its attempt to address this issue of patient education, the AAAHC Institute for Quality Improvement released its Patient Safety Toolkit #1, addressing ambulatory surgery and perioperative screening for obstructive sleep apnea, with future plans to release Toolkit #2, addressing DVT prophylaxis. This allows for yet another opportunity to develop similar toolkits for use by both practitioners and patients in the office-based surgical and procedural settings.
Fred E. Shapiro, D.O. is Assistant
Professor of Anesthesia,
Harvard Medical School, Beth Israel
Deaconess Medical Center, Boston.
Richard D. Urman, M.D., M.B.A., CPE
is Assistant Professor of Anesthesia, Harvard Medical School, Brigham and Women’s Hospital, Boston.