Considerations for the assistant

Trends in health care predict increased use of assistants, or advanced practice providers (APPs), by physicians in the treatment and care of patients. For the urologist in the operating room, the use of these nonphysician providers to help with surgery can come with an increased unease because of liability from errors that cause harm to patients or staff. Although these concerns have not been supported by evidence at this time, suggestions have been made about how to address this apprehension, and there are some recommendations on how to use the skills of the assistant while increasing safety in the operating room.

Indications for the present and near future of minimally invasive urologic surgery forecast that urologists will be increasingly likely to use assistants at the bedside in the operating room. The forces outside the operating room creating these conditions are the result of three trends for urologic health care in the United States. First, according to projections from the US Census Bureau ( www.census.gov/content/dam/Census/library/publications/2014/demo/p25-1140.pdf ), over 55 million Americans will be older than age 65 by 2020, and that number will increase annually to 80 million by 2050. Before 2030, people older than 65 years will constitute over 20% of the entire population and will continue to do so through at least 2050. As the population ages, urologic care will increasingly be required. Next, the Congressional Budget Office estimates that the expansion of health care under the Affordable Care Act will increase the number of persons with insurance by an additional 32 million by 2017. Last, paralleling the aging population of the United States, data from the American Urological Association (AUA) predict that the number of urologists retiring from practice or decreasing the number of patients they see owing to semiretirement is projected to increase through 2025. Furthermore, owing to the 1997 Balanced Budget Act, the number of Accreditation Council for Graduate Medical Education (ACGME) urology residency slots remains fixed at 170; therefore the AUA reports that the number of graduates who achieve American Board of Medical Specialties (ABMS) certification will not be able to compensate for those retiring or for the increased demands for care placed on urologists. Measures to compensate for the coverage gap in urologic care will be manifold, including the decrease in prostate-specific antigen screening, an increase in watchful waiting for prostate and kidney cancers, and increasing use of outside specialties such as primary care and interventional radiology for treatment of urologic conditions. Health professionals assisting the urologist in the operating room will vary in their roles and responsibilities and may include not only a urology resident or fellow but a physician assistant (PA) or advanced practice registered nurse (APRN). For the remainder of this chapter, both PAs and APRNs are referred to as APPs.

In December 2014, the AUA released the Consensus Statement on Advanced Practice Providers ( www.auanet.org/common/pdf/advocacy/advocacy-by-topic/AUA-Consensus-Statement-Advanced-Practice-Providers-Full.pdf ), which outlines the professional organization’s support and guidelines for use of APPs. The remarks in the AUA statement are largely for the use of APPs by urologists in general; however, the application of practices and principles influencing their use should be extended into the operating room. The document states that “The official position of the AUA is that APPs work in a closely and formally defined alliance with a urologist that serves in a supervisory role. This physician-led, team-based approach provides the highest quality urologic care. As the physician-led, team-based approach evolves, so do the definitions of supervisory and collaborative models of care between physicians and APPs.”

APPs are professionals with national certification and state licensing who usually fall into two groups. PAs are professionals who have become nationally certified and subsequently licensed by the state to practice under the supervision of a physician. An APRN is a nursing professional who, after completing a Bachelor of Science degree program, has some advanced training and becomes independently licensed by the state under the regulation of that state’s board of nursing. Once national certification is obtained, an APP is allowed to assist the urologist in the operating room. The specific tasks that APPs are allowed to do are governed by state licensing and hospital operating room or surgical center bylaws. Surgeons and APPs are strongly encouraged to have a copy of applicable regulations and be familiar with them. The AUA Consensus Statement on APPs provides a well-written guide on the educational background, training, and certification required for each profession, in addition to links to related state-specific regulations.

The AUA Consensus Statement states “The role of the APP in a urology practice is dependent on many factors, including academic versus private practice, large versus small group, APP experience, physician comfort level, and state laws. The supervisory/collaborative model in urology may be described as delegated autonomy. This autonomy process has a natural growth over time as the physician and the APP become accustomed to working together, which leads the team to provide the highest level of quality urological care.” This is also the case in the operating room with minimally invasive urologic surgery. Exercise of privileges will vary according to practice setting, regulation by agencies, and surgeon and APP dynamics. Although the questions of liability and coverage for urology residents and fellows are well defined, they are not as clearly defined for APPs.

The foremost concern when working with APPs is legal liability. The AUA frames the concern for urologists using an APP as follows: “The greatest risk for malpractice arises when practitioners engage in practice beyond their competency base either because of a lack of protocol, disregard for protocol, or inability to secure adequate collaboration or oversight. It is also important to remember that in any given environment, APPs are held to the same standards of practice as physicians; there are no separate guidelines for care outcomes that apply only for APPs.” The Consensus Statement provides a discussion addressing whether use of an APP to provide care resulted in any increase in legal liability and concluded that it did not, nor did it increase the costs of providing care or negatively affect the quality of care. However, as APPs are increasingly used, it can be expected that the rates of legal action will increase correspondingly. More important, the document makes general recommendations about how to reduce legal liability risks to the urologist, along with suggestions specific to the PA and APRN professions. Again, it is strongly recommended that this document be read and its suggestions followed. With regard to legal liability, APPs need to know explicitly what they are allowed to do and not allowed to do according to the surgeon and federal, state, local, and operating room requirements.

Understanding of the federal, state, and hospital regulations that apply to assisting in the operating room is key to properly using the skills of an assistant. When operating room safety is truly the first priority, anxieties about legal liability, injury, and accidents and other concerns return to their proper proportions and places.

The safety of the patient and the team is the first priority. Culture drives behaviors, and behaviors determine outcomes. The operating room is a culture of safety, and as such it is locally owned and driven, with guidelines and recommendations in mind. I recognize that the goal of zero harm to patients or staff in the operating room is technically impossible while performing any surgery; however, it is the progress toward the perfection of zero harm that will help improve the culture, behavior, and outcomes. Safety for the patient often translates into safety for the rest of the surgical team in many areas, including improving communication among surgical team members, decreasing staff concerns over previously unidentified problems, and strengthening the operating room organizational culture. The surgeon should encourage the APP to spearhead the effort to maintain safety in the operating room. The desired outcome of delegating this to the APP is to allow the surgeon to concentrate his or her energies on taking care of the patient and functioning to the greatest degree as a team leader in the operating room. The assistant should become integrated into existing efforts of institutional “second-order” problem-solving—identifying current problems and creating methods to avoid future harm. Some groups meet on a regular schedule to evaluate problems with the “Three W’s and How”: (1) What happened? (2) Why did it happen? (3) What can be done to reduce the risk? and (4) How is it proved that the risk was reduced? Safety groups that examine questions such as these benefit from input from diverse groups of professionals and patients. An example of a scientific safety system that is becoming widely used and accepted is a comprehensive unit-based safety program (CUSP). It is likely that where you operate already has a safety program such as CUSP in place. A CUSP program in the operating room, as in other health care units, uses all stakeholders in safety, including patients, their families, and care administrators. The idea behind use of a broad-based group is to include, to the greatest degree possible, those involved in care of the patient by drawing on the strengths of the varied perspectives. CUSP should do the following:

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Educate on the scientific approach to safety.
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Charge members with finding areas for improvement by asking questions that presume risk, such as “How will the next patient be harmed?”
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Incorporate a senior administrative member who has the authority and ability to unite different units such as sterile processing, the preoperative unit, the postoperative unit, and the nursing floor.
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Regularly review data to monitor safety problems, study and identify defects, and create safer systems for delivery of care. It is important that these recommendations come with a priority designation so that those with the greatest influence on safety and the most practicable can be implemented first.
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Execute recommendations by using techniques and technologies for effective deployment of safety measures.

What a CUSP chooses to focus attention on depends on its members, and it may choose to incorporate outside safety guidelines, for example, those of The Joint Commission (TJC; formerly The Joint Commission on Accreditation of Healthcare Organizations [JCAHO]). Under its mission “to improve healthcare for the public,” TJC established the National Patient Safety Goals (NPSGs) program in 2002 ( https://www.jointcommission.org/the_joint_commission_mission_statement/ ). The NPSGs were established to help accredited organizations, such as hospitals and surgical centers, address specific areas of concern regarding patient safety. In the past, some goals have included areas of focus specifically affecting safety in the operating room. Examples of these include targeting the spread of infection secondary to multidrug-resistant organisms (MDROs), catheter-related bloodstream infections (CRBSIs), and surgical site infections (SSIs). TJC’s new regulations for CRBSI and SSI prevention apply not only to hospitals but also to ambulatory care and ambulatory surgery centers and affect accreditation of those sites surveyed. The NPSGs now also include patient engagement efforts as well. Recommendations are based on feedback received by TJC and are updated on a routine basis in an effort to constantly improve safety. All current NPSG recommendations have direct bearing on minimally invasive urologic surgery. The NPSGs for 2015 are available at www.jointcommission.org/assets/1/6/2015_HAP_ NPSG_ER.pdf .

One of the most important safety measures that can improve every laparoscopic and robotic-assisted surgical case is use of a checklist. A checklist is more than just a time-out to confirm the patient’s name and date of birth. When used in a format similar to the United Nations World Health Organization (WHO) outline for a surgical safety checklist, it is a comprehensive three-phase safety check ( Fig. 6.1 ). The first phase, “Sign In,” lists tasks that are to be completed before the induction of anesthesia. More important, the patient is actively involved in this phase to confirm his or her identity, if applicable. Tasks also include site marking with indelible ink, confirming the surgical procedure, and providing surgical and anesthesia consent. Other risks are measured with the patient awake, such as allergies, airway, and blood loss. The second phase, “Time Out,” is performed before incision. This phase includes an introduction of staff and roles and an agreement by all present on the patient identification, procedure, and site. It should also cover the administration of appropriate antibiotics for prophylaxis and anticipated problems from the anesthesia, surgical, and nursing teams. The third and final phase is “Sign Out. “ This important phase records what procedure was performed, the number and names of the specimens, and instrument and sponge counts. Also included are reports of postoperative concerns for the patient from the surgical, nursing, and anesthesia teams. Notes should be made of any equipment problems and priority assigned for a safety concern to be addressed before the next case. This last item should also be reported to the CUSP team along with any other notes so that trends may be identified and tracked and safety process solutions found. After the publication in 2008 of the WHO recommendations, the use of checklists in the operating room has been validated by many retrospective studies, notably reducing the frequency of wrong-site surgeries. There is also a subjective feeling that nursing staff are the most compliant of all the groups in using the checklist. Song and colleagues published their findings in a frequently cited article, “The second ‘time-out’: a surgical safety checklist for lengthy robotic surgeries” ( www.ncbi.nlm.nih.gov/pmc/articles/PMC3689613 ). The study was designed to function as “a checklist conducted three to four hours after the start of surgery” for the purpose of assessing safety and increasing communication among the operating room staff to address their specific concerns. It is a good example of what the WHO operating room checklist guidelines ( Fig. 6.1 ) recommend for adapting a checklist to fit the purposes of a specific venue.