Applying Donabedian's Theory as a Framework for Bariatric Surgery Accreditation

Structure

The first dimension of Donabedian's SPO model—structure—is defined as the setting where care takes place. The primary premise of the structure component is that given the right setting, high-quality medical care will exist. ⁵ The structure or setting of an organization is multi-faceted, including material and human resources, and organizational factors, such as leadership and safety culture, all of which influence the delivery of healthcare.

Material resources include facility layout, number of licensed beds, supply and equipment inventory, and the availability of specialty equipment. Human resources include staffing numbers, as well as staff qualities such as educational level, board certification, and specialty certification. Organizational factors refer to the type of facility (e.g., academic medical center, community hospital, critical access hospital), as well as the organizational practices within the facility, such as the mechanism for peer review, reimbursement, leadership support, safety culture, and medical staff organization. ³

When considering the bariatric accreditation requirements, the standards require that hospitals demonstrate a structure that adequately supports caring for the bariatric patient. The accreditation programs require that facilities provide appropriate accommodation for the bariatric population. Material resources that must be considered include furniture, specialty equipment, and building structures. While preparing for the COE accreditation process, an assessment of the current state of these structural resources must be completed. The areas to be considered include building entries and waiting areas, treatment and procedure rooms, patient rooms and bathrooms, elevators, availability of wheelchairs, and availability of beds and other furniture that can accommodate the bariatric patient.

The American Disabilities Act (ADA) and American Institute of Architects (AIA) do not provide bariatric guidelines for building or design; ⁶ however, special attention should be given during the design of doors, such as designing hallways with revolving-door style entrances, to accommodate the bariatric population. Another area to consider is the structural foundation and configuration of patient bathrooms. The traditional wall-mounted toilets can accommodate 300 lbs, while floor-mounted toilets can accommodate up to 5000 lbs. ⁶

The prevalence of obesity in the United States is 26.7%, ⁷ which suggests that at least 25% of the hospital's furniture should accommodate the needs of the bariatric patient. Use of love seats or chairs without arms is one way to meet the demand for accommodating furniture in waiting areas and throughout the hospital. Today, most hospital beds have a capacity of 500 lbs. However, beds with a capacity of 1000 lbs are available for purchase or lease.

The operating room (OR) equipment must also meet the needs of the bariatric patient. This includes specialized OR beds and tables, and specially sized instruments that are appropriate for the population, such as larger endotracheal tubes, larger retractors, larger stapling instruments, and longer surgical instruments. Hospitals undergoing the accreditation process must ensure sufficient quantities of wheelchairs, lifts, transfer boards, and weighing scales that can accommodate the size of a bariatric patient.

Staff credentialing is another element that is included in the structure of care. The surgeons must be licensed and board certified from the American Board of Surgery (ABS) or the American Osteopathic Board of Surgery (AOBS). Evidence of continuing education, as mandated by ABS and AOBS certification criteria, may need to be provided during the accreditation review process.^8,9Although not required for certification, another element of an organization's structure as it relates to bariatric care is the number of nurses who are credentialed as certified bariatric nurses. This certification establishes the competence of practitioners of bariatric nursing in conjunction with standards recognized for safe and effective patient care. This certification is the only specialty certification available for nurses who take care of bariatric surgical patients.

Process

The second dimension of Donabedian's conceptual framework—process—is described as the intervention or service that provides patients with an improved outcome. This is commonly referred to as the “actual provision of care”. ⁵ Process is essential to the theoretical framework because process is what allows an organization to apply the high-quality medical care that is widely accepted and has been validated in the literature as influencing a specific outcome. Process characteristics are considered more proximal indicators of quality outcomes than structural characteristics because they are the actual activities performed by an organization. ¹⁰ While process is thought to have the biggest impact on outcome, ³ it also offers relevant feedback about the structure mechanisms already in place.

In order to be seamless and successful, process elements rely on structural attributes. When a healthcare organization is deficient in its structural components, such as leadership, safety culture, or human capital, it risks compromising quality and the quality-improvement process, which in turn, compromises the potential for quality improvement.

In the bariatric COE accreditation, demonstrating effective processes is imperative. In this instance, processes refer to both clinical practice processes for the delivery of care, as well as to the office management processes. Clinical practice, based on the best available evidence, ensures effective care of the bariatric surgical patient. Examples of clinical practice processes include the use of best-practice guidelines, and the development and implementation of care delivery policies and procedures that are evidence-based. These processes guide staff in providing care for patients during both the preoperative and postoperative phases. Healthcare organizations should create their own specific practice guidelines, policies, and procedures based on recommendations set forth by organizations such as the American Society for Metabolic and Bariatric Surgery (ASMBS) and/or other literature and guidelines that support best bariatric practice. An example of a best-practice guideline that can be used in healthcare organizations would be the ASMBS Integrated Health Nutritional Guidelines for the Surgical Weight Loss Patient. ¹¹ One of the best-practice recommendations included in the ASMBS guidelines is the diet and texture progression recommendation. This recommendation states that for all non-complicated post-bariatric surgery cases the patient's diet should consist of clear liquids for 2 days and then a full liquid diet for 10–14 days. ¹¹

Another important aspect of program development and maintenance includes the organization's criteria for both patient selection and discharge readiness. All program criteria should be based on available guidelines and recent research. Best-practice guidelines for bariatric surgery patients are intended to assure a coordinated effort and seamless patient care delivery throughout the care continuum, including the preoperative phase, the inpatient phase, discharge, and the post-acute care phase. Best-practice guidelines ensure standardized, safe, and effective care delivery by a multidisciplinary team.

Developing specific patient selection criteria contributes to the bariatric program's success. These criteria vary between healthcare facilities, but are typically based upon the levels of bariatric surgery centers. ⁸ For example, a bariatric facility at a tertiary care center may accommodate high-risk bariatric patients, while other centers, not equipped for such patients, might narrow their selection to include patients with less co- morbid conditions. ⁸

Office-management processes are an important aspect that contributes to streamlined care of the bariatric patient. Office-management processes need to include policies and procedures that ensure safe, effective, and standardized workflow within the bariatric office practice. Some examples of these processes include approval of insurance coverage, standardized telephone triage of information, scheduling of appointments by guided scripting with personnel trained in customer service, establishing preoperative workshops, assistance with scheduling endoscopy and other procedures, and the development and scheduling of community-based educational offerings and seminars. Personnel guidelines may assist in providing role delineation and responsibilities for each employee, which can potentially help clarify expectations, improve patient satisfaction and education, and/or addresses bias related to bariatric care. Existence of these guidelines may help to improve work flow and ensure efficiency in the care delivery process of bariatric patients.

Outcome

The final dimension of Donabedian's conceptual model—outcome—is the explicit result that occurs from the antecedents of structure and process. Outcomes are the ultimate indicator of care provided. ⁵ Outcomes not only provide concrete measurements of individual performance, but collectively they also can serve as benchmarks for quality performance. Benchmarks establish a target for performance, which allows an organization to compare and judge the effectiveness of the care provided. Great structures and processes alone cannot validate quality care; instead, an organization must excel in all three areas to demonstrate success.

Outcomes reflect the results of service quality and can assist healthcare organizations to identify potential areas of risk, non-compliance, and underachievement, as well as provide guidance for quality-improvement opportunities. Comparing outcomes across organizations can often become a catalyst for change within an organization. Outcomes also offer data to frontline care providers, which allow them to initiate improvement projects or evidence-based practice projects to enhance the care or services provided in their individual areas. This, in turn, promotes continuous quality improvement and allows for the SPO model to be set in motion yet again.

Reporting the results and outcomes of the bariatric surgery program is an important part of the bariatric accreditation process. The reporting process may vary with the level of bariatric surgery accreditation the facility has, but overall the most important outcomes reviewed by the credentialing body are 30-day mortality rate, 30-day morbidity rate, and 30-day readmission rate. ⁸

ACS and SRC collect data from bariatric surgical programs for benchmarking purposes, as well as to track and verify patient outcomes after surgery. The National Surgical Quality Improvement Program (NSQIP), sponsored by ACS, is the gold-standard source for bariatric surgery outcomes. The NSQIP database collects data about patient factors and characteristics, as well as patient outcomes, including preoperative risk factors, intra-operative variables, and 30-day postoperative mortality and morbidity. Examples of NSQIP outcomes include the existence of wound events, such as wound category, wound dehiscence, date of occurrence, and treatment provided, as well as respiratory events such as pneumonia, unplanned intubation, pulmonary embolism, and ventilator use greater than 48 h. ⁸ A multitude of other postoperative complications and outcomes are also tracked. NSQIP conducts inter-rater reliability of the data, ensuring the quality of collected data, ⁸ and provides risk-adjusted outcome rates for each center. ¹²

In addition to morbidity, mortality, and readmissions, NSQIP collects and tracks other patient characteristics that are specific to the bariatric population. These measures include height, weight, BMI, and co-morbidities, such as sleep apnea, GERD, hyperlipidemia, hypertension, diabetes, and musculoskeletal parameters. ⁸ At each follow-up visit these parameters are assessed and documented in the NSQIP database. The risk-adjusted report can be generated in real time by the hospital organization and is distributed every six months from the accreditation agency. In addition to providing each organization with a summary of its outcomes, these reports also allow for benchmarking against similar hospitals.

The SRC's Bariatric Surgery Center of Excellence (BSCOE) program also tracks outcome data. The SRC collects patient data during all phases of care through the Bariatric Outcomes Longitudinal Database (BOLD). ⁹ Reported outcome data from this database includes: readmission within 30 days of discharge, inpatient mortality, post-discharge 30-day mortality, and 31–90-day mortality. ¹³ These national databases provide both bariatric programs and accreditation agencies with information to evaluate the quality and safety of care provided objectively.

A recent study concluded that bariatric programs should also focus on psychosocial, nutritional, and functional outcomes. ¹⁴ Examples of these outcomes include a patient's physical functioning, mental functioning, and vitality after bariatric surgery. In addition, the use of a holistic approach when caring for post-surgical patients may also be helpful in the recovery process. ¹⁴ Although these outcomes are not tracked by any current national surgical databases, individual organizations could very easily monitor and track these outcomes in their own program via spreadsheets, databases, or computer applications and programs used for such monitoring purposes.