Safety in the Outpatient Setting

Geoffrey R. Keyes

An unfavorable result in plastic surgery can range from patient dissatisfaction with a surgical outcome to severe morbidity or mortality. Patient satisfaction is not necessarily directly related to the effectiveness of care or patient safety. However, patient-centered care to produce the best possible result is an important goal for surgeons.

In addition to establishing safe standards for surgical care and ensuring the quality of surgical training, a systematic approach to care delivery is necessary. Although assessing unfavorable results is subjective in some instances, the recognition of “never events” as unfavorable is clear. Preventing never events requires a team approach to vigilant documentation of each phase of surgical care.1

Never Events

Ken Kizer, MD, former CEO of the National Quality Forum (NQF), a nonprofit organization, introduced the term never events in 2001 to refer to events that should never occur in surgical practice.¹ The list has been expanded to seven categories¹ (Box 10.1).

Outpatient Surgery

Outpatient surgical procedures have increased dramatically over the last 20 years as a result of the development of safe surgical standards, cost-effectiveness, and convenience. Between 2001 and 2008, there was a greater than 50% increase in the number of Medicare-certified ambulatory surgical centers in the United States. In 2007 these facilities performed more than 6 million procedures.^2,3

The Federal Trade Commission (FTC) changed the course of health care advertising in 1975 when they accused the medical profession of “restraint of trade,” persuading physicians to begin advertising.

California was one of the first states requiring accreditation for ambulatory surgery facilities. Concerned by in creasing commercial advertising for office-based cosmetic surgery, California drafted a bill that required accreditation for those facilities that were not licensed or participating in Medicare. When a pediatric patient died under general anesthesia, the legislature passed Assembly Bill 995 in 1994.⁴

The state favored accreditation because they didn’t have the financial resources to survey the many office-based facilities in existence. This freed the state to invest its time and resources into investigating complaints or adverse incidents. They were then able to inspect fewer facilities and concentrate their efforts on those suspected of being unsafe, providing oversight to the performance of both the surgery facilities and the accrediting associations.

Legislation requiring accreditation or licensure of outpatient surgery facilities has been increasing slowly in most states. More than half of the outpatient facilities operating throughout the United States do not have accreditation or licensure.⁴

American Association for Accreditation of Ambulatory Surgery Facilities

Established in 1980, the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF) developed an accreditation program for outpatient surgery facilities that requires 100% compliance with its standards for surgery center operation. Over the past 30 years, AAAASF has become the largest organization in the United States that accredits outpatient office-based surgery centers.⁵ In addition to accreditation of facilities in the United States, AAAASF is now an international organization that accredits single-specialty and multispecialty facilities that provide care in all of the surgical specialties. It has branched out to include gastroenterology, podiatry, and oral and maxillofacial surgery. With the advent of AB 995, the number of accredited facilities by this organization increased dramatically.

Box 10.1 Never Events

1. Surgical or Invasive Procedure Events

• Surgery or other invasive procedure performed on the wrong site

• Surgery or other invasive procedure performed on the wrong patient

• Wrong surgical or other invasive procedure performed on a patient

• Unintended retention of a foreign object in a patient after surgery or other invasive procedure

• Intraoperative or immediately postoperative or postprocedure death in an ASA class 1 patient

2. Product or Device Events

• Patient death or serious injury associated with the use of contaminated drugs, devices, or biologics provided by the health care setting

• Patient death or serious injury associated with the use or function of a device in patient care, in which the device is used or functions other than as intended

• Patient death or serious injury associated with intravascular air embolism that occurs while being cared for in a health care setting

3. Patient Protection Events

• Discharge or release of a patient or resident of any age who is unable to make decisions to other than an authorized person

• Patient death or serious injury associated with patient elopement (disappearance)

• Patient suicide, attempted suicide, or self-harm that results in serious injury, while being cared for in a health care setting

4. Care Management Events

• Patient death or serious injury associated with a medication error (e.g., errors involving the wrong drug, wrong dose, wrong patient, wrong time, wrong rate, wrong preparation, or wrong route of administration)

• Patient death or serious injury associated with unsafe administration of blood products

• Maternal death or serious injury associated with labor or delivery in a low-risk pregnancy while being cared for in a health care setting; updated: applicable in hospitals, outpatient, and office-based surgery centers

• Death or serious injury of a neonate associated with labor or delivery in a low-risk pregnancy

• Patient death or serious injury associated with a fall while being cared for in a health care setting

• Any stage 3, stage 4, or unstageable pressure ulcers acquired after admission or presentation to a health care setting

• Artificial insemination with the wrong donor sperm or wrong egg

• Patient death or serious injury resulting from the irretrievable loss of an irreplaceable biological specimen

• Patient death or serious injury resulting from failure to follow up regarding or communicate laboratory, pathology, or radiology test results

5. Environmental Events

• Patient or staff death or serious injury associated with an electric shock in the course of a patient care process in a health care setting

• Any incident in which systems designated for oxygen or other gas to be delivered to a patient contains no gas or the wrong gas or are contaminated by toxic substances

• Patient or staff death or serious injury associated with a burn incurred from any source in the course of a patient care process in a health care setting

• Patient death or serious injury associated with the use of physical restraints or bed rails while being cared for in a health care setting

6. Radiological Events

• Death or serious injury of a patient or staff member associated with the introduction of a metallic object into the MRI area

7. Potential Criminal Events

• Any instance of care ordered by or provided by someone impersonating a physician, nurse, phar macist, or other licensed health care provider

• Abduction of a patient or resident of any age

• Sexual abuse or assault on a patient or staff member within or on the grounds of a health care setting

• Death or serious injury of a patient or staff member resulting from a physical assault (i.e., battery) that occurs within or on the grounds of a health care setting

Abbreviations: ASA, American Society of Anesthesiologists; MRI, magnetic resonance imaging.
Source: Reproduced from Never Events. AHRQ Patient Safety Network. 2014. Available at https://psnet.ahrq.gov/primers/primer/3/never-events.

AAAASF has promoted mandatory accreditation or licensure for all surgery centers throughout the United States, championing safe surgical care. Safety and improvement in patient care is their mission.4

In 2001, recognizing the importance of accreditation, the American Society of Plastic Surgeons (ASPS) and the American Society for Aesthetic Plastic Surgery (ASAPS) established a mandate that all of the members from each society must operate only in accredited facilities to maintain membership, regardless of state requirements.⁴

A variety of surgical procedures, performed by all surgical specialties, are now performed on an outpatient basis. The outpatient surgery setting offers convenience, patient privacy and comfort, increased efficiency, and lower costs.

Facilities that are licensed or accredited must adhere to standards established by both their state and accrediting associations. Although monitoring outpatient facility compliance with these standards is necessary to confirm patient safety, assessing the quality of care delivered is a difficult task.

With this concept in mind, I created the first Internet-based quality assurance program (IBQUA) for AAAASF in 1999. This was the first Internet-based outpatient surgery data collection system that used the concept of checklists for ensuring specific quality assurance processes were conducted in a surgical case. This database has provided information for previously published papers on outpatient surgery outcomes.^6,7

The aerospace industry has used checklists for safety since 1935. Standardized procedures were developed after the crash of the Boeing 299 Flying Fortress. Analysis of the crash revealed the cause to most likely be failure to recognize that the elevator locks were still engaged during the takeoff. This would have been noticed if a checklist had been used before takeoff. The complexity of preparation of a plane for flight and this incident inspired the creation of checklists to document compliance with vital functions necessary for flight.⁸

Taking a lead from the aerospace industry, I developed the first compliance management program for outpatient surgery⁴ in 2002. The program was designed to monitor nine modules of outpatient surgery center management to facilitate compliance with necessary standards. Physician and staff credentialing; patient routing through the preoperative, intraoperative, and postoperative phases of care; vendor agreements; and formulary, incident, and pathology reports and reports to satisfy accrediting associations and states were all covered using the checklist concept for ensuring completion.

Expanding upon this idea, my colleagues and I developed a peer-review program⁹ that integrates the surgical process with outcomes. Included in the program documentation is a checklist for collection of data pertinent to patient routing through preoperative, intraoperative, and postoperative care; the American Society of Anesthesiologists (ASA) Physical Status Classification System; the Caprini Risk Assessment Model checklist; and comorbidity fields. Through analyzing the diagnosis, procedure, and perioperative management in concert with outcomes, there is an opportunity to determine the efficacy of the entire care process and improve its delivery. Use of this program at the time of surgery, either through a printout of the checklists or on a computer or tablet, documents compliance with accepted standards for patient care and provides clinical data that may help better define evidence-based medicine (EBM).⁹

Data Collection

Data collected on morbidity and mortality in the AAAASF mandated peer-review system (IBQUA) has been previously reported through 2008. An updated report was published in 2013 and is the basis for the statistics in this review.^9,10

Analysis of Sequelae

Overview

There were 5,525,225 plastic surgery procedures performed on 3,918,599 patients, with the average number of procedures per case being 1.41. Breast augmentation, abdominoplasty, mastopexy and reduction mammoplasty, liposuction, and facelift and related procedures were the five most commonly performed procedures² (Fig. 10.1). The total number of sequelae reported was 21,994. There was an incidence of 0.40% sequelae, or 1 in 251 plastic surgery procedures, and 0.56% sequelae, or 1 in 178 cases.²