Patient Safety in Office-Based Surgery

Patient Safety Committee's Project Team on Ambulatory Surgery Center/Practitioner Office Errors

1. Office-Based Surgery Today

   For most of the twentieth century, surgical procedures were performed in hospitals; and patients were frequently admitted at least overnight. As the century came to a close, free-standing ambulatory surgery centers (ASCs) were accepted as safe, less expensive locations to deliver high quality service. By the 1990's, over half of surgeries were performed in ASCs.¹ According to a draft report of the Federation of State Medical Boards (FSMB), 70% of surgeries are now performed in outpatient settings, and 20-25% of these are performed in physician offices.² An American Medical Association (AMA) report predicts that outpatient surgery may make up 85% of surgical procedures by 2005. As the ASCs assumed a greater percentage of the caseload, they came under increasingly stringent accreditation oversight, which required them to collect data that established ASCs as safe and economically effective.

   Within a few years, the physician's office became an increasingly important supplier of surgical services (as seen in the FSMB statistics referred to above). However, physicians' offices, unlike ASCs, were not felt to require regulation and oversight. As long as most procedures had taken place in hospitals, this was probably true because hospitals provided a "safety net" for poor outcomes, and few states had significant regulatory oversight laws on their books. Those that did frequently did not provide for effective enforcement. The federal government became involved briefly, holding hearings in the early 1990s to highlight the lack of oversight in many office-based facilities³. The hearings did not produce federal oversight, and thus this responsibility fell to the states.

   Although office-based procedures are now estimated to number up to 1.2 million annually many state boards are still studying the matter, and as of 2003 only 10 had adopted actual regulations¹. As a result, unlike the ASCs, there are very little data on the safety of office-based procedures; such data as there are, are not comforting.

   For most states, reliable data on surgical risk do not exist, or are very limited in scope. Morello,et al⁴, studying all procedures performed in accredited office-based facilities, found a mortality rate of 1.7 per 100,000. Grazer and de Jong⁵ found a mortality rate of 19 per 100,000 in their study of office-based procedures limited to liposuction. In their analysis of relative risk for procedures in Florida, Vila et al found a ten-fold increase of both adverse events and deaths in the office versus ASC setting.¹ Extrapolated nationally, they state that mortality in office as opposed to ASC venues could result in 96 additional deaths annually.

   The only study of office errors limited to orthopaedists was conducted by the Professional Liability Committee of the AAOS (unpublished data) in 2003. The study consisted of a census of all claims against orthopaedists insured by a large West Coast insurance company, and detailed review of those claims incurred in the ASC or office setting. In this study, all claims were assigned to one of three categories depending on where the event occurred: ASC, office, and "all other," which was assumed to represent primarily hospital-based claims. The study examined claims based on incidents that occurred between 1986 and 1996.

   Due to varying number of orthopaedists insured by the company from year to year (276 to 516), this is expressed as number of claims per 100 insured orthopaedists. There has been a gradual decrease in the rate of these "other" claims at an average rate of 3.5% per year.

   During the first three years, outpatient categories represented one claim or fewer per year per 100 orthopaedists. Thereafter they began to increase, and by the latest two years the combined total of claims based on ASC and office errors has exceeded that for "traditional" hospital-based claims and accounted for over half of all claims.

   Chart 1 displays the data for claims originating from hospital, ASC, and offices and illustrates the growth in the percentage of claims arising from ASCs and offices.

   

   It is not clear whether the increase in claims in outpatient settings is based solely on an increase in the number of procedures performed in outpatient settings. This increase may also be due in part to an increased rate of claims; an increased complexity of cases now done in outpatient settings, and/or other system factors.

   If U. S. orthopaedists (currently estimated at 17,000) generally incur professional liability claims at the same rate as those in this study, the annual number of claims by category is:

   Hospital-based	884
   Office-based	816
   ASC-based	272

2. Regulation and Accreditation Issues in OBS⁶

   State regulation

   States that provide oversight for office-based surgery have generally taken one of two approaches. One is to regulate through statutes or regulations that have the force of law. Noncompliance may be punishable by disciplinary proceedings against a health care professional's license. Other states have elected a less sweeping model by issuing voluntary guidelines or position statements, typically adopting the recommendations of a task force or committee appointed to study the issue. While these guidelines or statements are not intended to result in licensure discipline, they may be used to establish the standard of care in medical liability actions.

   The issue of training and qualification of the surgeon can generate a lot of debate in drafting of rules. Commensurate with the level of anesthesia used for a given procedure, state regulations may require that the physician have staff privileges at a licensed hospital within reasonable proximity and that he or she be able to document completion of training such as board certification or eligibility by a board approved by ABMS or that he or she have comparable background, training, or experience. For some high-risk procedures, the physician may be required to have staff privileges to perform the same procedure in a licensed hospital.

   States may apply different regulations to physicians' offices depending on the magnitude of the procedure (e.g. minor) and the level of analgesia/anesthesia. As with all state regulations, the exact application of the rules depends on the specific language. The agency responsible for enforcing the rules, usually the state medical board, will generally respond to individual inquiries. Other sources for information include state and national specialty societies, state medical societies and national accrediting bodies.

   The future
   

   Indications are that growth in office-based surgery will continue. Public scrutiny and a patchwork of regulations will follow. New data on patient safety and technological advances will likely force states to consider more regulation.

3. Responsibilities of the Surgeon in OBS: Communication and System Responsibilities
   

   Performing operative procedures in the practitioner's office creates a false impression that the procedure is minor, carries minimal or no risk, a good outcome is assured, and the problem will be fixed and the patient on his or her way in a matter of minutes. This perception is a misperception; and it is important that neither the patient nor the surgeon fall into this way of thinking. In performing office-based surgery, it is the surgeon's responsibility to manage all processes and implement all safeguards that are typically the responsibility of others in the ASC or hospital OR.

4. Best Practices in Office-Based Surgery
   

   Orthopaedic surgeons who perform office-based surgery can improve patient safety by addressing the following eleven issues:

   1. Facility Accreditation
   2. Physician Training and Competency
   3. Patient Selection
   4. Informed Consent Criteria
   5. Anesthesia Guidelines
   6. General Recommendations for Preventing Drug Name Mix-Up
   7. Facility Maintenance
   8. Physician and Office Personnel Training in Emergency Procedures and Resuscitative Techniques
   9. Emergency Transfer Protocols
   10. Reporting Adverse Events
   11. Disclosure of Adverse Outcomes
   1. Facility Accreditation

      While accreditation is not usually required for OBS, the accreditation process ensures that the quality of surgical services meets nationally established standards. In the absence of accreditation, the following principles should be followed:

      • Governance: A physician or governing body should establish written policies and procedures. He/she is responsible for activities of the facility and its staff and for ensuring compliance with local, state and federal regulations.
      • Credentialing: Health care practitioners will have appropriate licensure or certification and be qualified to perform services consistent with their education, training and experience. Credentialing will be established by written policy.
      • Quality Control: The organization should develop a quality assurance program that strives for continuous quality improvement (CQI) and risk management.
      • Medical Records: The organization should maintain legible, complete medical records for each patient and have policies that address retention, storage and privacy of the records.
      • Environment: The facility should comply with all governmental laws, codes and regulations, including those pertaining to construction, occupancy, fire safety, accommodations for the disabled, OSHA and disposal of medical and hazardous waste.

   2. Physician Competency and Training
      • Surgeons should be board-certified or board-eligible.
      • Procedures performed should be in the scope of training and practice of the surgeon.
      • Surgeons should maintain core privileges at an accredited hospital or ambulatory surgery center for the procedures they perform in the OBS.

   3. Patient Selection
      • Perform a history and physical examination appropriate to the procedure and level of analgesia/anesthesia. Consider routine clearance by the primary care physician.
      • Order appropriate laboratory and cardio-pulmonary tests.
      • Select patients by criteria that include the American Society of Anesthesiologists (ASA) Physical Status Classification System⁷ and the levels of sedation or anesthesia⁸ required by the procedure.
      • Choose procedures appropriate for an OBS and of duration and level of complexity that allows the patient to recover and be discharged in a timely manner.
      • If treating pediatric patients, assure appropriate personnel, equipment and medication is available for infants and children. Please refer to the American Academy of Pediatrics' policy statement on monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures.⁹

   4. Informed Consent Criteria
      • Discuss and document in the medical record the risks, complications, benefits and alternative treatments.
      • Discuss and document the nature and objectives of planned anesthesia and surgery.
      • Discuss and document the discharge process and post-surgical care. Provide a 24-hour telephone number.

   5. Anesthesia/Analgesia/Sedation Guidelines
      • The level of anesthesia should be appropriate for the patient, surgical procedure, clinical setting, education and training of personnel and the equipment available.
      • The person who administers anesthesia should be licensed, qualified and working within his/her scope of practice. This person should be physically present during and after the procedure, and until the patient is discharged from anesthesia care.
      • Assign each patient to an ASA Physical Status Classification System category.
      • Use intra-operative monitoring, appropriate to the patient and type of anesthesia. Consider use of a pulse oximeter and ECG monitor.
      • A reliable source of oxygen, suction, resuscitative equipment and emergency drugs should be immediately available.

   6. General Recommendations for Preventing Drug Name Mix-Up

      A common system failure is confusing drug names which leads to potentially harmful medication errors. The Joint Commission for Accreditation of Healthcare Organizations (JCAHO) published a sentinel event alert in 2001¹⁰ and the Institute for Safe Medication Practice (ISMP) published a medication safety alert in 2002¹¹ on look-alike and sound-alike drug names. Orthopaedic surgeons need to be aware of measures for preventing drug name mix-ups in office-based surgery.

      • Maintain awareness of look-alike and sound-alike drug names as published by various safety agencies (e.g. epinephrine and ephedrine, fentanyl and sufentanil, hydromorphine and morphine)
      • When telephone/verbal orders are necessary, encourage readback and spelling of the product name and state its indication.
      • Encourage patients to questions medications that are unfamiliar, or look or sound different than expected.

   7. Facility Maintenance
      • Back-up power, sufficient to ensure patient safety, should be immediately available.
      • All equipment, appropriate to the procedure, should be maintained, tested and inspected to the manufacturer's recommendations.
      • Antiseptic environment and sterile supplies appropriate to the procedure should be maintained.

   8. Personnel Training In Emergency Procedures and Resuscitative Techniques
      • Written protocols should be developed for cardio-pulmonary emergencies and other internal/external disasters. All facility personnel should be trained in these protocols.
      • Consider having at least one physician credentialed in advanced resuscitation (e.g. ATLS, ACLS) available, with appropriate resuscitative equipment.
      • Consider having office personnel with direct patient contact trained in Basic Life Support (BLS).
      • Written protocols, medications and equipment should be immediately available to treat malignant hyperthermia when triggering agents are used.

   9. Emergency Transfer Protocol
      • Develop a written protocol for the safe and timely transfer of patients to a pre-specified alternate care facility, when extended or emergency services are needed for the patient's health and safety.
      • Protocols must include a written transfer agreement with a convenient (nearby) hospital, or all surgeons at the OBS facility should have admitting privileges at a convenient (nearby) hospital.
      • Assure that the local ambulance or emergency response team can respond in a timely manner.

   10. Reporting Adverse Events

       The reporting of certain unexpected adverse events will improve the safety of patients who are treated in an OBS. Patient safety reporting systems often include documenting/reporting:

       • Patient death within 30 days of a procedure.
       • Unscheduled transport of patients to a hospital for observation or treatment for a period in excess of 24 hours.
       • Unscheduled hospital admission of patients within 72 hours of discharge from an OBS.
       • Wound infection.

   11. Disclosure of Adverse Outcomes

       Although errors are unexpected, adverse clinical events are a difficult part of medical practice. They do not necessarily warrant a claim or litigation. Timing of the disclosure is very important. Once it is clear that a complication or adverse event has occurred, the physician should arrange to communicate this with the patient, family, or significant other as soon as possible. The physician who is aware of medical errors should understand that admitting the error may not mean admitting liability.

       • A sincere expression of empathy will convey to the patient that you care about what has happened. Explain all the facts.
       • Any delays increases difficulty of explaining the circumstances in a way patient can accept.
       • Delays also contribute to patient's feelings of distress, blame, and anger.
       • Be straightforward, telling what physician knows at that point in time, without attributing blame or guilt.
       • "I don't know" or "I don't know yet" may be honest answers to a patient's specific question.
       • Reassure patient that you will share more information as soon as you learn it.

5. Patient Safety Checklists (Pre-Operative and Post-Operative)

   The AAOS is dedicated to improving patient safety by implementing programs to ensure that patient safety is a cornerstone of orthopaedic practice. In order to assist physicians' efforts to improve patient safety in the practitioner's office, the AAOS has developed concise patient safety checklists to be used pre-operatively and post-operatively. These checklists are best clipped directly to the patient chart, and completed and signed by the orthopaedic surgeon. The pre-operative checklist ensures that the surgeon has considered issues related to this particular patient's safety for the specific procedure and that certain safety-related processes have been performed prior to surgery. The post-operative checklist ensures that the surgeon considers issues related to the safety of her/his patient at discharge. These checklists are available to be downloaded free of charge on the AAOS website at www.aaos.org.

1. Vila, H, et al, Comparative Outcomes Analysis of Procedures Performed in Physician Offices and Ambulatory Surgery Centers. Arch. Surg. 2003, 138. 991-995.
2. Report of the Special Committee on Outpatient (Office-Based) Surgery, Federation of State Medical Boards, April 2002.
3. Regulators Look at Ways to Control Office-Based Surgery, Linda Prager, American Medical News, Nov. 13, 2000, p. 13.
4. Morello, DC, et al, Patient safety in accredited office surgical facilities. Plast. Reconstr. Surg. 1997, 99. 1496-1499.
5. Grazer, FM, and de Jong, RH, Fatal outcomes from liposuction; census survey of cosmetic surgeons. Plast. Reconstr. Surg. 2000, 105. 436-446.
6. Office Surgery Accreditation and Regulation, AAAHC, 2001.
7. ASA Physical Status Classification System. American Society of Anesthesiologists.
8. ASA Continuum of Depth of Sedation.
9. Guidelines for Monitoring and Management of Pediatric Patients During and After Sedation For Diagnostic and Therapeutic Procedures. American Academy of Pediatrics.
10. Sentinel Event Alert, JCAHO. Issue 19, May 2001.
11. What's in a name? Ways to prevent dispensing errors linked to name confusion, Medication Safety Alert. Institute for Safe Medication Practices, June 12, 2002.