Volume:   43-5

Author:   Roger J. Leslie

Categories:  Medical Negligence, Ambulatory Facilities, Legislation and Legislature

Over the past 30 years, surgery in the United States has shifted from hospital inpatient surgery to outpatient surgery in doctor’s offices and in ambulatory surgical centers. The shift from inpatient to outpatient surgery was stimulated both by Medicare’s coverage of ambulatory surgery beginning in 1982 and from improvements in medical technology. Today, about 60% of all surgeries performed in the U.S. are performed in ambulatory surgical facilities. Outpatient surgery is most common in the disciplines of ophthalmology, gastroenterology, plastic surgery, dermatology, urology, ENT, and gynecology.

Patient safety is a top concern for surgery conducted outside the safety net provided by a hospital’s emergency department, medical specialists, medical services, and intensive care unit. A patient undergoing plastic surgery that lasts several hours may develop deep vein thrombosis during her recovery. A patient receiving liposuction or breast implants may suffer a punctured lung (pneumothorax). Anesthesia provided during a variety of procedures can lead to respiratory arrest or to life- threatening allergic reactions.

Nationally, ambulatory surgical facilities have low frequencies of adverse outcomes for patients because the facilities select for low risk patients. By definition, a patient who does not need hospitalization and who can be admitted and discharged in one day will be at low risk for a bad result. For example, patients seeking plastic surgery are typically healthy when they enter the ambulatory surgical facility. In light of the lower risk, a surgery that results in death or injury is particularly tragic.

The State of Washington does not license ambulatory surgical facilities. That will change in July of 2009 when ESHB 1414 signed by the Governor in May of 2007 takes effect and requires the State Department of Health to license ambulatory surgical facilities. Interest groups will submit reports to the Department of Health (DOH or the Department) by December 15, 2007. The rule making process is expected to be completed by late Spring of 2009.

Under the new law, an ambulatory surgical facility is any distinct entity that admits and discharges a patient within 24 hours, with the primary purpose of providing outpatient surgical services. The statutory definition does not include hospital outpatient clinics, dentists, or physicians’ offices that do not require the use of general anesthesia.

Each ambulatory surgical facility must be certified by Medicare or accredited by organizations that are approved by the Department of Health. Medicare currently certifies 220 ambulatory surgical facilities in the State of Washington. Under the new law, a survey of each facility must be completed at 18 month intervals and will be based on quality data submitted to the Department. A survey by Medicare or by one of the approved organizations may substitute for a survey by the Department.

The new State law focuses on patient safety through requirements for emergency preparedness and quality review. The steady diet of low risk patients can cause surgeons, nurses, and other staff at ambulatory surgical facilities to lose the edge needed to treat a patient in an emergency. The staff at ambulatory surgical facilities may not be prepared with materials or experience. Under the new law, each ambulatory surgical facility is required to have (1) a safety and emergency training program; (2) a written transfer agreement with a local hospital, and (3) a procedural plan for handling medical emergencies.

The statute does not define the parameters of the transfer agreement between the hospital and the ambulatory surgical facility. Little is known about how the Department of Health will implement these provisions during the rule making process. If hospitals and ambulatory surgical centers are allowed to bargain freely, the hospitals could require payments and services from the facility in consideration for the transfer agreement.

Each ambulatory surgical facility must have a quality improvement program that will be implemented by a committee within the facility. The program will include an education program, maintenance of information about individual practitioners, review of incident reports, and a procedure for resolution of patient grievances.

Documents prepared by or for the committee will not be discoverable; however, the Department of Health, the medical quality assurance commission, the board of osteopathic medicine and surgery, or the podiatric medical board may audit the records of committee decisions. The discovery ban is focused on the content of a committee meeting or documents prepared specifically for the committee. The statute does not preclude the discovery of (1) the identity of person involved in the medical care, (b) the testimony by any person with independent personal knowledge relevant to the civil action, (c) testimony regarding the restriction or revocation of an individual’s staff privileges, (d) disclosure of the fact that staff privileges were terminated or restricted including disclosure of the specific restrictions and the reasons for the restrictions, or (e) discovery of the patient’s medical records required to be made regarding the care and treatment received.

Review procedures that have proved to be effective in hospitals in the past may not be as effective in ambulatory surgical facilities. While hospitals have the staff and resources to assemble committees and implement quality improvement programs, an ambulatory surgical facility with a limited number of staff may not be equipped to implement an effective program.

Ambulatory surgical facilities must report adverse actions that they take against a health care provider regarding unprofessional conduct. Before receiving privileges to operate at an ambulatory surgical facility, a physician must disclose any associations with hospitals or other ambulatory surgical facilities and any pending actions for misconduct or for medical malpractice.

The facility must provide patients or their families with information about unanticipated outcomes. A notification to a patient under the statute is not an admission of liability and no apology may be admitted in a civil trial. The statute is silent as to the length of the period that falls under the protection of this statute. Would an apology a year after an adverse event be inadmissible at trial? Hopefully the regulations adopted by the Department of Health will clarify this issue. The regulations require that each facility post the phone number of the Department of Health where a complaint may be filed.

The Washington statutes do not go as far as similar laws in other states to protect patient safety. In Illinois, all surgeons operating in an ambulatory surgical facility must also have privileges to practice at a hospital in Illinois. This provision ensures that a physician will not become isolated from the variety of experiences and intellectual ferment of a hospital practice. A physician must submit to a review by the hospital’s quality assurance committee each time his or her privileges come up for renewal. The requirement for hospital privileges also prevents ambulatory surgical facilities from being refuges for surgeons who have lost their hospital privileges because of substandard performance. Hospitals in Washington require physicians with privileges to carry professional liability insurance. Ambulatory surgical facilities may have no such requirement.

Other states and Medicare limit surgeries at ambulatory surgical facilities to 90 minutes or less and allow a recovery period of four hours or less. These requirements are intended to prevent the nebulous and dangerous practice of performing all day complex surgeries in doctors’ offices. The Washington statute does not have such requirements. A surgery could last four or more hours during the 24 hours between admission and discharge allowed in Washington. While facilities that are certified under the more restrictive Medicare statutes will be subject to the 90 minute surgery and four hour recovery limitations, facilities that perform elective surgeries often do not accept Medicare and are governed by the State limitations only.

Another problem spot in ambulatory surgical facilities is the provision of anesthesia without an anesthesiologist present. Many facilities employ certified registered nurse anesthetists (CRNAs) instead of anesthesiologists. In Illinois and in New York, each nurse anesthetist must be supervised by a physician who is qualified by law, regulation or hospital appointment to supervise the administration of anesthesia.

The new Washington statutes are a good start at protecting patients from substandard practices at ambulatory surgical facilities. They do not go far enough in some very important patient safety issues such as regulating the administration of general anesthesia and it is too soon to know how the Department of Health or the Courts will interpret the statutes. Anyone can follow the rule making process for ESHB 1414 by requesting updates from the Department of Health through an e-mail to byron.plan@doh.wa.gov.

Roger Leslie

is an EAGLE member of WSTLA and he practices in the areas of Medical Malpractice and Products Liability. He was a bio-medical research scientist and he has a Ph.D. in biology. He is of counsel at Chemnick Moen Greenstreet.