beware the risks of office-based surgery...liposuction, breast augmentation or reduction,...

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This publication is not intended to be and should not be used as a substitute for specific legal or risk management advice. Readers should obtain specific legal or risk

management advice in addressing issues discussed in this newsletter

NNEWSLETTEREWSLETTER Volume Five - Number Six June, 2009

Beware the Risks of Office-Based Surgery Each day, patients across the United States undergo surgical procedures in physician offices. In days past, such surgical interventions took place in an ambulatory surgery center or in a hospital day-surgery unit. Although office-based surgery procedures vary, examples include rhinoplasty, herniorrhaphy, liposuction, breast augmentation or reduction, lithotripsy, arthroscopic knee surgery, and face-lifts and other types of cosmetic surgery. Ophthalmologists and dental surgeons have also seen a shift to offering office-based surgical procedures. A number of factors have contributed to the shift to office-based surgery. Access and costs have influenced many patients. For care providers, the ability to control surgical time and maximize reimbursement have been two important factors. Although the setting for such procedures may have shifted to the office setting, the risks associated with the surgeries have not diminished. This includes the risk linked to anesthesia administered in the office setting. The issue is of such import that the American Association of Nurse Anesthetists has cautioned patients that

“Emergency equipment and anesthesia monitoring devices in office facilities should be equivalent to those that would be necessary for the same surgical procedures performed in a hospital or freestanding ambulatory surgery center.”1

BEWARE THE RISKS OF OFFICE BASED SURGERY




A recent New York case2 highlights what can happen when office-based anesthesia support is not equipped to handle an emergent situation. The case sends a cautionary note for those who might be inclined to minimize the risks associated with office-based surgery. It also helps to reinforce the importance of good risk management practices for this growing vista in elective surgery. The New York Case. A 42 year-old woman who lived in Ireland heard publicity about Dr. S. and the plastic surgery he offered in his New York City office. The doctor met with the woman in Ireland and discussed with her procedures he could perform for her. They agreed that Dr. S. would complete five procedures: a face-lift, a nasal septal reconstruction, augmentation of the chin, augmentation of the upper and lower lips, and eyelid blepharaoplasty.3 Dr. S. never informed the woman that in 2004 he had been charged with misconduct by the New York State Department of Health. The charge was based on repeated episodes of negligent practice of medicine between May 1985 and December 1993. The doctor had agreed with the charge and his medical license was placed on probation for three years. Dr. S. never apprised the woman that at the time of the proposed surgery his license was still on probation. Further, he never disclosed to the patient that he had been the subject of 30 lawsuits brought by patients upon whom he had conducted facial surgeries.4 The woman traveled to New York City on March 14, 2007. Surgery was performed on the same day. An anesthesiologist, Dr. M.S., provided anesthesia for the patient. The three-hour operation started at 6:15 PM and it was completed at approximately 9:10 PM. During the procedure bleeding occurred during some of the procedures, including the reconstruction of the nasal septum.5 Shortly after the operation was completed, Dr. S. left the office. Dr. M.S. remained in the office, going in and out of the recovery room until he left at approximately 11:00 PM. Dr. M.S. claimed that before he left for the night, the recovery room nurse, Ms. A-F, told him that the patient was groggy but fine. He also claimed that he gave his telephone numbers to the nurse and told her to call him should she need his assistance. For her part, the nurse said that she did not remember the anesthesiologist giving her any instructions and that she already had his telephone number incorporated into her cell phone.6





The next day at approximately 6:30 AM Nurse A-F was helping the patient to the bathroom when the woman became dizzy. The woman told A-F that she was fainting. Nurse A-F helped the patient lie down on the floor and reconnected her to the monitoring device. Although most of her vital signs were good, the blood oxygen saturation level was down to 70%. The nurse initiated mouth-to-mouth resuscitation. She then removed from a cabinet an Ambu bag and mask. The nurse attached the Ambu Bag to an oxygen canister and placed the mask over the patientʼs mouth and nose and started squeezing the bag. As she did so, she realized that there was resistance. She recognized that this was indicative of an airway obstruction. Using her cell phone, the nurse called the operating room nurse in the office practice, the doorman to the building, the surgeon and the anesthesiologist. The doorman came in and called 911. An ambulance call report indicated that EMS personnel arrived at 6:40 AM and found the patient in cardiac arrest. They intubated the patient and commenced life care. The patient was transported to a local hospital where she arrived at 7:09 AM. The woman was admitted to the ICU and the prognosis was poor. The next day it was determined that the patient did not have any brain stem activity. On the following day, March 17, the patient was declared dead.7 In the lawsuit that followed the plaintiff sued the surgeon, his professional corporation, the anesthesiologist and the recovery room nurse. A judge granted a motion for summary judgment requested by the anesthesiologist. The judge did so on the basis of an expert witnessʼs affirmation that Dr. M.S. had “appropriately left the patient with a nurse in the recovery room.”8 The expert also suggested in the affirmation that the anesthesiologist was not “required to stay with the patient and to monitor her.”9 The judge who granted the defense motion concluded that the anesthesiologist did not have a “duty to ensure that the recovery room nurse was qualified to manage an airway obstruction and to intubate the patient.”10 The court reasoned that since the nurse was an employee of the surgeon, not the anesthesiologist, the latter could not be held accountable for her actions.11 The plaintiff appealed the grant of summary judgment. In overturning the grant of summary judgment, the Appellate Division of the New York Supreme Court found that there were sufficient issues of fact whether or not the anesthesiologist deviated from the accepted standard of care for a jury to determine.12





To reinforce this point, the court noted:

“Even if defendant had met his prima facie burden, the strength of the affidavit of plaintiffs' expert was sufficient to establish the existence of factual issues. He opined, with compelling logic, that a doctor is required to ensure that a patient who has undergone “major airway and facial surgery” be “left in the hands of properly trained medical and/or nursing staff who are qualified to assess and manage an airway obstruction and qualified to intubate patients,” and that it was particularly “crucial” in a nonhospital setting that the nurse be so qualified… .. It makes eminent sense that certain precautions would be necessary in the event that such a situation arose.”13

The latter point merits particular attention. In this case it was disputed whether or not the nurse had received training on intubation. Even if she had received such training, it may not have mattered in this case. The longer the time frame between training and actual application of a skill set, the greater the opportunity to lose proficiencies in completing a task. This is as true for a person managing complex computer programming as it is a nurse handling without assistance the intubation of a patient with an apparent airway obstruction. Here it was not made clear the length of time between training and the emergent situation in the office-based surgery practice. Moreover, left unanswered was whether or not the training provided was appropriate for a nurse handling an intubation unassisted and without the ability to obtain rapid back up from qualified care providers. The point is that in office-based surgery situations – like the present case – training alone is not the issue. Rather, it is whether or not the training was appropriate for the setting, whether the nurse received regular refresher training and whether she demonstrated the clinical competency to complete an intubation in such a circumstance. Such issues may be resolved if the case does proceed to trial. At the same time, the case offers a good “lesson learned” for those involved in office-based surgery programs.





Observations on the New York Case. The facts of the case are in dispute between the plaintiff and defense. Reading the ruling in depth, it is apparent that the anesthesiologist and the nurse disagreed upon what each other said and assumed about the recovery room nurseʼs ability to intubate the patient. Indeed the nurse admitted that she did not know how to intubate patients.14 The court ruling is quite narrow. It focused on a motion granted for summary judgment. Should the case proceed to trial, a jury would have to sort through the evidence to decide whether or not the anesthesiologist was culpable for negligence. What is of interest here is the courtʼs description of the situation and the emphasis on the “nonhospital” nature of the case. The court went to some length to describe the background of the surgeon and his disciplinary encounters with the New York State Board of Health. It offers what might be seen as a telling perspective on an egregious office-based surgery practice. Some might suggest that surely most office-based practices have some level of oversight and accountability. However, absent some type of regulatory framework that is enforced by state authorities, it is possible that complications can result in catastrophic outcomes. Proponents of office-based surgery are apt to point out that even in the most sophisticated hospitals and ambulatory surgery centers, untoward outcomes may occur with equally bad results. While this may be true, the fact remains that in hospitals and ambulatory surgery centers, backup is readily available on premises. Thus when patients experience post-operative complications, there are apt to be experienced, credentialed, and trained care providers available to initiate immediate life-saving care. This is in contrast to office-based surgery practices with limited staffing and back-up resources. The New Wave of Legal and Accreditation Standards Recognizing the growth potential in office-based surgery, some states have decided to enact laws and promulgate regulations to address patient safety in such settings. Although the laws vary in design, the intact is similar: to set minimum requirements in order to maintain patient well-being.





A number of states have used their legal authority to set forth position statements as guidance for office-based surgery practices.15 North Carolina has taken this approach.16 Examples of such laws can be found in Florida,17 New York,18 and New Jersey.19 The Joint Commission,20 the American Association for Accreditation of Ambulatory Surgery Facilities,21 and the American Association for Ambulatory Health Care22 all offer office-based surgery accreditation. State laws that set accreditation as a requirement reinforce the relevance of accreditation for the office-based surgery setting. For example, in New York,

“Pursuant to Public Health Law section 230-d, "Licensees" (physicians, physician assistants and specialist assistants) who perform invasive or surgical procedures using more than minimal sedation must practice in an accredited setting. The Commissioner of Health designated The Joint Commission, the American Association for the Accreditation of Ambulatory Surgical Facilities (AAAASF) and the Accreditation Association for Ambulatory Health Care (AAAHC) as the organizations which are authorized to perform the accreditation of practices which meet the definition of Office Based Surgery. A licensee who fails to practice in an accredited setting after July 14, 2009 may be guilty of professional misconduct.”23 [Emphasis added]

Risk management and quality improvement style theme are commonplace among the laws, regulations, accreditation requirements and position statements. Central to these requirements are policies, procedures, and practices that address:

Patient reception Patient screening Anesthesia Clinical competency of personnel Patient safety Credentialing Consent to treatment Management and reporting of adverse events Infection control Peer review Performance improvement





Nuances do exist. Thus some state requirements apply to those care providers who do not hold staff privileges at a hospital. The New Jersey rule takes this approach.24 The underlying premise seems to be that without monitoring and oversight exerted under a hospitalʼs medical staff bylaws, having an “alternate privileging” approach operated by the New Jersey Medical Board provides some degree of quality review for licensed physicians operating an office-based surgery practice. Viewed against the backdrop of these legal, regulatory and accreditation standards the New York case seems to reinforce the importance of such requirements. The trend toward hospitals purchasing physician practices – some of which may continue to offer office-based surgery – demonstrates the importance of healthcare facilities extending risk management services to such medical groups. It is an important consideration in terms of addressing potential liability exposures in office-base surgery programs. Risk Management Strategies for Office Based Surgery Practices A number of practical enterprise risk management strategies can help address office-based surgery practices. These strategies are applicable to both hospital-owned and independent office-practice programs and include more than those that offer cosmetic procedures. Hence, the strategies are useful for dental surgery offices and those who engage in restorative and interventional treatment programs. These strategies include the following:

1. Complete a GAP Analysis of Current Practices. Conduct a complete review of clinical practices in the office-based surgery practice that takes into consideration patient screening, preparation, anesthesia, recovery, and documentation practices. Develop a plan to modify those practices are in need of improvement.

2. Use a Comprehensive GAP Assessment Tool.

Take into consideration applicable state law and regulation requirements as well as accreditation requirements when designing the GAP assessment tool. Incorporate into the tool relevant federal requirements that address accessibility (Americans with Disabilities Act), HIPAA, and provisions that address the need for assistance with language interpretation. Recognize that state and federal requirements set minimum standards. Building in practice criteria can





help facilitate good risk management and patient safety for the delivery of office-based surgical procedures.

3. Establish Clear Guidelines for Patient Selection for Office-Based

Surgery. Follow guidance from respected, national professional groups in the selection of patients who want to undergo elective surgical procedures in the office-based setting. In taking such an approach consider important guidance from anesthesia providers such as the American Association for Nurse Anesthetists (www.aana.org). Implement a process for careful screening and good “drill down” questions to identify those patients for whom it may be prudent to consider procedures in an ambulatory surgery center or an acute care facility.

4. Follow Good Practices for Staffing. Make certain that office policies, procedures and protocols follow prudent methods for staff hiring, training and demonstrated competencies for the office-based surgery practice. Build into contracts with staffing agencies or agreements with anesthesia providers appropriate requirements for demonstrated competencies in the office-based surgery practice.

5. Stress the Importance of Team Management Training. Recognize that intra-operative and post-operative care management is important in terms of patient safety and risk management. Reinforce this point with team on team training and requiring demonstrated proficiencies for all involved in the clinic care of office-based surgery patients. Address identified opportunities for improvement.

6. Utilize Good Patient Communication and Informed Consent Practices. Implement effective comprehensive communication practices with patients. Offer clear instructions on how to prepare for the procedure, what to do if the patient becomes ill prior to elective surgery, and what to bring and not to bring on the day of surgery. Follow established state requirements on informed consent to surgery. Build into the consent process information about the choice to have the procedure done in a healthcare facility rather than an office-based setting. Make certain that the consent process is documented in accordance with state requirements, and, when relevant, applicable accreditation standards.





7. Emphasize the Importance of Complication Management.

Anticipate the potential for complications to occur at any stage of a patientʼs office-based surgery experience. Provide clear and concise guidance for managing complications. Include in this approach immediate access to cardiac resuscitation, rescue medication from anesthesia-induced malignant hyperthermia, rescue kits for allergic reactions and other essential approaches to avoid permanent untoward outcomes in the office-based surgery practice.

8. Have a Dedicated Transfer Agreement. Work with legal counsel on implementing a transfer agreement for

prompt transfer of patients with complications to an acute care facility. 9. Follow Effective Infection Control Procedures. Make certain there is in place a comprehensive infection control

program for the environment of care in which surgical procedures are performed in the office based setting. Include in this plan specifications for sterilization, cleaning and disinfecting equipment. Encourage use of a quality control audit for infection control. Address identified opportunities for improvement.

10. Implement Effective Post-Operative Recovery Plans. Follow national standards, guidelines and “good practices” in the design and implementation of post-operative, office-based surgery recovery plans. Examine carefully staffing, equipment requirements as well as the propriety of patients “boarding” overnight in the office-based practice. Built into the plan “safe practices” for ambulation following conscious sedation and anesthesia.

11. Close the Loop on Discharge Instructions. Implement a patient-oriented discharge process for patients who have undergone office-based surgical procedures. Consider a number of practical issues such as:

• Medication • Diet • Level of activity • Return to work • Possible complications • What to do if a complication occurs





• Scheduling follow-up visits • Who to call regarding questions • Teach –back on information provided • Health literacy level of written information

Documentation of the discharge process is important, including who completed it, the time, date, and staff memberʼs name and signature. Identifying who was the responsible person with the patient at the time of discharge is important as it helps to reinforce the process in most office-based surgery practices that the patient has an identified individual accompanying him or her home.

12. Address the Issue of Security for Office-Based Surgery.

Develop a process for secure storage of patient belongings in the office-based surgery setting. Take into consideration wallets, watches, handbags, cell phones, hearing aids, eyeglasses and dentures. Consider lockers and documentation of the “safe storage” process.

13. Education for Office Personnel. Provide orientation and in-service education to office staff personnel on their respective roles and responsibilities. Include in this process reception personnel and administrative support staff. Give them guidance on how to handle patient or family calls or requests, especially with respect to questions about postponing the procedure or post-operative complaints and complications.

14. Close the Loop with Follow-Up Calls. Develop a set of questions for designated personnel to use when calling post-procedure patients. Use the calls to identify possible complications or side effects that mitigate to encouraging a visit to the practice or encouragement to seek emergency medical attention. Build in an “escalate call” process for complications, side effects complaints or expressions of dissatisfaction. Document the date and time of the call, and the name of the person with whom the staff member communicated.





Conclusion. Office-based surgery is part of a realignment in the delivery of healthcare services. While it may offer patients more rapid, cost-effective access to treatment, it is not without risks. Designing a risk management program for office-based surgery practices is important in terms of meeting a growing array of state laws and regulations, and also, accreditation standards. It is also a good approach in terms of risk prevention and risk reduction while at the same time providing patient safe care.

If you would like assistance with developing an office-based risk

management program, please contact us at (860) 242-1302.





1 “Fact Sheet Office Based Anesthesia and Surgery at a Glance.” AANA, 2009. Accessible at: http://www.aana.com/ForPatients.aspx?ucNavMenu_TSMenuTargetID=68&ucNavMenu_TSMenuTargetType=4&ucNavMenu_TSMenuID=6&id=301

2 L.C. v. M.S., 879 NYS2d. 440 (A.D. 2009). 3 Id. at 441. 4 Id. 5 Id., at 442. 6 Id. 7 Id., at 443. 8 Id. at 444. 9 Id. 10 Id. 11 Id. 12 Id. at 447. 13 Id at 445. 14 Id. 15 For a state-by-state compilation of laws and regulations, on office-based surgery and

ambulatory surgery facility requirements, see, “All States Governing Entity for Ambulatory Surgery Facilities and Office based Surgery Facilities,” accessible at: www.aaaasf.org.

16 N.C. Medical Board, Position Statement on Office-Based Procedures, January 1, 2003, accessible at: http://www.ncmedboard.org/position_statements/detail/office-based_procedures/

17 Board of Osteopathic Medicine, Florida Administrative Code 64B15-14.007 Standard of Care for Office Surgery, effective June 6, 2009. See also, Board of Medicine, Florida Administrative Code, 64B8-9.009 Standard of Care for Office Surgery, effective 9/3/2007. Note that on June 19, 2009, the Florida Board of Medicine Issued a Notice of Proposed Rule-Making “64B8-9.009: Standard of Care for Office Surgery to develop rule amendments to address additional requirements for physician office surgery settings.

18 New York State Public Health Law § 230-d Office-Based Surgery and New York State Public Health Law § 2998-e Reporting of Adverse Events in Office-Based Surgery.

19 Surgery, Special Procedures, And Anesthesia Services Performed In An Office Setting N.J. Administrative Code 13:35-4a.12. (2003). 20 The Joint Commission accessible at:

http://www.jointcommission.org/AccreditationPrograms/Office-BasedSurgery/ 21 American Association for Accreditation of Ambulatory Surgery Facilities at www.aaaasf.org 22 Accreditation Association for Ambulatory Health Care,www.aaahc.org 23 http://www.health.state.ny.us/professionals/office-based_surgery/. 24 Surgery, Special Procedures, And Anesthesia Services Performed In An Office Setting N.J. Administrative Code 13:35-4a.12. (2003).

beware the risks of office-based surgery...liposuction, breast augmentation or reduction,...

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