REGULATION IMPROVING PATIENT SAFETY?
D ARLENE G HAVIMI*
In fact, hot dog vendors on the street are more regulated than office surgeons. At least their carts have to be inspected to see if they are meeting public safety cod es.1
Surgery in an outpatient setting has grown enormously over the last several decades. 2 Convenience, improved technology, and advanced techniques have made surgery outside the hospital a feasible and less costly alternative.3 Over eight million outpatient surgeries were performed in 2000,4 and by 2 005 it is estimated that eighty percent of all surgeries will be performed in an outpatient facility.5 One quarter of those outpatient surgeries will be performed in the private physician’s office.6
While surgery has migrated to the doctor’s office, oversight and regulation have not followed.7 Private physician offices are not subject to the same state and federal regulatory oversight as hospitals and freestanding surgical centers (an outpatient setting).8 A doctor’s medical license establishes the authority to perform a procedure of any scope and c omplexity in a private office, regardless of the level of training, certification, and experience of the physician.9 The on ly
* Third year law student and Manuscript Editor of the Widener Law Review at Widener
University School of Law. Second-place winner of Epstein, Becker and Green, P.C. Eighth
Annual Health Law Writing Competition.
1. NEW YORK STATE SENATE COMMITTEE ON INVESTIGATIONS, TAXATION, AND
GOVERNMENT OPERATIONS, PROBLEMS OF OFFICE SURGERY (1999), available at http://www.senate.state.ny.us/Docs/surgery.htm [hereinafter NEW YORK STATE SENATE
2. Elizabeth M. Lapetina & Elizabeth M. Armstrong, Preventing Errors in the Outpatient Setting:
A Tale of Three States, HEALTH AFF., July/Aug. 2002, at 27.
3. Id. at 27 (Noting that the cost of a surgical procedure outside the hospital is sixty to seventy-five percent less than in the hospital). A freestanding surgical center has two or more operating rooms, several physicians, surgeons, anesthesiologists, and nursing staff, and many states require accreditation of these facilities. Id. at 27-28. Types of procedures performed in an office setting include cancer screening, biopsies, colonoscopy, arthroscopy, cataract removal, microlaparoscopy, pregnancy termination, liposuction, and cosmetic augmentation/reduction.
Adrian Hochstadt, How States Regulate Office Surgery - A Primer, 22 PLASTIC SURGICAL NURSING 133,
4. Lapetina & Armstrong, supra note 2, at 27.
5. Rod J. Rohrich & Paul F. White, Safety of Outpatient Surgery: Is Mandatory Accreditation of
Outpatient Surgery Centers Enough? 107 PLASTIC & RECONSTRUCTIVE SURGERY 189, 189 (2001).
7. Robert del Junco et. al., Report of the Special Committee on Outpatient (Office-based) Surgery, 88
J. MED. LICENSURE & DISCIPLINE 160, 162 (2002).
9. COMMITTEE ON QUALITY ASSURANCE IN OFFICE-BASED SURGERY, A REPORT TO: NEW
YORK STATE PUBLIC HEALTH COUNCIL & NEW YORK STATE DEPARTMENT OF HEALTH, ix (2000)
Widener Law R eview
oversight of physicia ns who practice o utside a hospital o ccurs through the licensing and disciplinary functions performed by either a state’s Board of
Medicine or Department of Health.
The current standard for private physicians is that “[t]he care delivered in such offices is expected to meet prevailing standards of care for the licensed profession .” 10 Without the benefit of uniform guidelines that specify the standard of care, for the patient seeking surgery in a private physician’s office, the rule of caveat emptor prevails.11 The federal government held hearings in the 1990s to discuss regulation of outpatient settings, but no legislation resulted.12 States have been left to respond to public pressure concerning safety in the office setting.
While some states have created