Framing the issue:

The United States has about 5,300 Medicare-certified ambulatory surgery centers, which perform more than 25 million procedures a year.

The number of outpatient surgeries in U.S. community hospitals jumped more than 40 percent, from 12.3 million in 1992 to 17.3 million, between 2002 and 1992.

During that same period, inpatient surgeries in community hospitals fell from 10.6 million to 9.5 million.

Growth in ambulatory surgery prompted attention to the quality of care and patient safety in that setting.

The government in 2012 launched an ASC pay-for-reporting program and a project aimed at improving patient safety in participating centers.

Although nearly two-thirds of U.S. surgeries are performed in the ambulatory setting, little is known about patient safety and care quality in this arena. But that’s quickly changing.

The dearth of information prompted studies showing that, although surgical complication rates in ambulatory settings are very low, the best safety practices aren’t always followed and the large volume of procedures — more than 25 million annually — means that in aggregate a substantial number of incidents occur.

Two federal programs, both launched in 2012, aim to make ambulatory surgery safer. One is a Centers for Medicare & Medicaid Services pay-for-reporting program specifically for ambulatory surgery centers. The other is the Agency for Healthcare Research and Quality’s Safety Program for Ambulatory Surgery, which is managed by the AHA’s Health Research & Educational Trust. Its goal is to improve patient safety across all ambulatory surgery settings — ASCs, hospital outpatient surgery departments and physician offices.

The AHRQ/HRET safe-surgery program features a yearlong intervention focused on the effective use of a surgical safety checklist and education on how to prevent infections and promote a culture of safety.

Another purpose of the four-year project is to gather information on where ambulatory surgery providers are in terms of patient safety and where problems might lie, says Mital Mehta, R.N., HRET director of clinical quality. The baseline data for ASCs before the safety program began was practically nonexistent, she says.

The first group of participants began its work in March 2013 and wrapped up in April 2014. That experience confirmed that surgical complication rates in ASCs are very low, Mehta says. However, the level of experience at the participating institutions varied widely. “Some ambulatory surgery centers are just starting to understand quality,” she says.

The first and second waves of participants, mostly ASCs and a few hospital outpatient surgery departments, also showed organizers how different ambulatory settings can be and how much their needs differ. ASCs and hospital outpatient departments have different administrative structures, policies, procedures and access to resources, Mehta notes. ASCs are subject to different regulations and often are certified by the Accreditation Association for Ambulatory Health Care, although some are certified by the Joint Commission.

The differences are evident even when ASCs are partly owned by hospitals, which generally view the centers as investments, says Bill Berry, M.D., chief medical officer at Ariadne Labs, a collaboration between Brigham and Women’s Hospital and Harvard School of Public Health. Unless they fully own the center, hospitals typically are silent partners in ASCs, and leave decision-making about quality and other matters up to physicians, he says.

The potential proliferation of accountable care organizations might change the relationship between hospitals and ASCs, Berry says. “The large institutions that have the wherewithal to assemble these ACOs may or may not want to contract with an ASC, or they might try to make it their own,” he says. “Or they might see themselves as having a real stake in controlling both what’s done at the ASC and the quality of it. Those issues are looming on the horizon.”

ASC quality shouldn’t be managed by a hospital with ownership interest in the surgery center, says Bill Prentice, CEO of the Ambulatory Surgery Center Association, a partner in the AHRQ/HRET program. “Licensed ASCs have to meet the Medicare conditions for coverage and any state licensing requirements, which could be different from the hospital,” he says. “I don’t think you could safely say that the hospital could impose what it does in that area on the ASC because the rules might be different. Regardless of ownership, everyone who has a stake in that center has the same interest at heart, which is to make sure patients get the care they need in the safest way possible.”

Meanwhile, surgical procedures in physician offices are largely unregulated, Berry says. “As far as safety standards around health care, the physician’s office is still kind of the Wild West.”

However, Berry says that a transition is going on in the ambulatory setting and that real attention is being paid to improving care and to showing that the care is good. The AHRQ-funded HRET project is evidence of that, he adds. The Harvard School of Public Health also works with HRET on the project.

The differences in ambulatory settings prompted HRET to begin arranging program participants by facility type. The third cohort of participants, which began work in April, and the fourth, which is set to launch this month, only include ASCs. HRET is planning a hospital outpatient surgery cohort for 2015 and eventually wants to offer programming to physician’s offices, Mehta says.

A not-so-secret agenda

A major focus of the project is effective use of a surgical safety checklist. The CMS quality reporting program requires ASCs to use a checklist. Hospital outpatient surgery departments and physician offices are not mandated to do so.

The trap that providers sometimes fall into, regardless of setting, is using the checklist as a list of processes they must check, rather than as a teamwork and communication tool, says Berry, one of the creators of the World Health Organization surgical safety checklist. The danger is that staff then focus more on checking off boxes than on the tasks they’re performing.

The HRET program “is aimed at helping nurses move surgeons and anesthesiologists from box ticking to having conversations,” Berry says. “It’s hard work because nurses have to talk to surgeons who are often owners of the ASC.” The program gives nurses tools to foster that communication, encourages them to engage in it, and gives guidance about how and where to start. “Culture change is our not-so-secret agenda,” Berry adds.

Although ASCs were required to use a checklist when the project began, the access to subject matter experts and the peer-to-peer learning the program offers helped participating centers to transform it from a mechanical exercise to a communication and teamwork tool.

“One of the changes that we made was insisting that our safety checklist was adhered to — that you actually did take that time out,” says Carol Culbertson, R.N., nursing director at Audubon Surgery Center, which is partially owned by Penrose–St. Francis Health Services in Colorado Springs, Colo. “And then it’s having more than just the physicians involved in the report. The circulator and the scrub techs — all of those people have input, and they shouldn’t be afraid to be able to say anything.”

At the Outpatient Surgery Center at Self Memorial Hospital, Greenwood, S.C., the post-op debriefing portion of the checklist was a particular focus. “We added more to it. It’s not just going over the counts and that type of thing,” says Teka Ward, R.N., staff nurse and education coordinator. “We go over what the procedure was, if any added procedures were necessary, any complications we might have had, any complications we might foresee with recovery, or any concerns that may come up with this patient.” Everyone from the anesthesiologist and the surgeon to techs have a voice.

Participating ASCs also find the project’s data collection and infection prevention components useful.

Some surgery centers in the first cohort continue to use HRET’s data-collection system even though their formal 12-month program has ended. “There were people in Cohort 1 who were collecting their data in notebooks,” Mehta says. “Our comprehensive data system is not just IT support. We have statisticians and data analysts who are there to help them interpret the results, and it’s been a really huge help.”

The staff at the Self Memorial ASC, which is 51 percent hospital-owned, found the infection prevention webinars about equipment sterilization and reprocessing beneficial. “You got a grasp of the issues the other facilities were finding as far as their turnover time or if the number of instrument sets needed to increase to reduce any chances of infection,” says Melanie Leach, R.N., assistant nurse manager and quality assessment and performance improvement committee coordinator. “It did give me a lot of tools to incorporate into my infection control program.”

The access to expertise in infectious diseases and sterile processing is advantageous because there have been outbreaks of infection based on problems with sterile processing of surgical instruments, particularly at ambulatory facilities, notes Dwight Burney III, M.D., a member of the American Academy of Orthopaedic Surgeons’ patient safety committee.

Although retired from practice, Burney remains involved with the New Mexico Orthopaedic Surgery Center in Albuquerque, which has applied to participate in a pilot of the HRET project specific to orthopedic surgery centers and is scheduled to begin this fall.

The differences with hospitals

So far, of the 263 HRET project participants, only 12 are hospital outpatient surgery departments, Mehta says. The curriculum for the future hospital-focused cohort must be adapted to take their differences from ASCs into account, Berry says. “If it’s not, the outpatient cohort will think we don’t know what we’re doing.”

Hospitals typically have personnel dedicated solely to infection prevention, while ASC staff handling those matters have other roles and might not have the same knowledge base. So the curriculum should reflect the extra resources hospital outpatient departments have.

Unlike ASCs, hospital outpatient surgery departments often don’t control equipment sterilization and processing practices because they’re handled by central supply, Berry says. So that part of the program will need adjustment.

Programming also must respect the variability even among hospital surgery departments, Berry says. At some, inpatient and outpatient surgery share the same staff and are managed together; at others, they’re separate.

Although checklist use is not mandated for hospital outpatient surgery departments, it will be part of the HRET program for that cohort. Some hospitals might already use a checklist on the inpatient side and some might not, so efforts to introduce one in outpatient surgery should take the inpatient surgery picture into account, Berry says.

Once participants are finished with the program, it’s important for them to keep the momentum going. “Part of your work is to look at your performance and never stop looking,” Berry says. The patient safety culture should be built into orientation for new staff and physicians.

Although the project ends in September 2016, supporters hope the work will continue. “The fact that we’ve been able to have these first few cohorts go through this program, learn from each other and, hopefully, develop a really good training tool that every ASC, hospital outpatient department and office-based clinic can use … to make sure they’re maintaining that culture of safety is time and energy and money well-spent,” Prentice says.

Geri Aston is a contributing writer for H&HN. 


REVEALING DATA

Much of the attention to patient safety at ambulatory surgery centers can be traced to a 2007 outbreak of hepatitis C infections at a licensed center in Las Vegas caused when single-use medication vials were used on multiple patients. In the wake of the event, Nevada used a Centers for Disease Control and Prevention tool to audit all 51 ASCs in the state. The audit found that 28 centers had lapses in infection control.

Those findings prompted the Centers for Medicare & Medicaid Services in 2008 to conduct a similar audit in three other states — Maryland, North Carolina and Oklahoma. Sixty-eight ASCs were assessed for compliance in five areas — hand hygiene, injection safety and medication handling, equipment reprocessing, environmental cleaning, and handling of blood glucose monitoring equipment, according to a June 9, 2010, Journal of the American Medical Association report on the study.

The audit found that 46 of the 68 centers had at least one lapse in infection control and 12 had lapses in three or more of the five categories. As a result, CMS now requires all states to use the infection control audit tool for ASC inspections. Centers with deficient practices must correct them, and ASCs that don’t fix problems risk termination from Medicare.

Another study, published in JAMA in February put the spotlight on hospital-owned ASCs and outpatient surgery departments.

The retrospective analysis of 2010 data from eight states found that three out of every 1,000 patients who had surgery in a hospital outpatient surgery department or a hospital-owned ASC had a surgical-site infection that required at least one ambulatory surgery visit or hospitalization within 14 days of surgery. That figure rose to almost five patients per 1,000 at 30 days post-surgery.

The findings show that the rate of clinically important infections following ambulatory surgery is relatively low. However, the large number of such surgeries — nearly 19 million in 2010 — means a substantial number of patients develop post-operative infections, the study’s authors note.


Want to be paid? Better report

This year, for the first time, ambulatory surgery centers face a Medicare payment penalty if they don’t successfully report measures in the Centers for Medicare & Medicaid Services ASC quality reporting program.

The program began in 2012 with five quality measures — patient burns; patient falls; wrong-site, wrong-patient surgeries; hospital transfers/admissions; and prophylactic intravenous antibiotic timing. Reporting on those first measures will determine whether an ASC will get a 2 percent reduction in its Medicare payment update this year.

The number of measures has increased each year and is now up to 10. CMS in July proposed an 11th mandatory measure and one voluntary measure for 2015. ASCs get two years to report measures before their payment level is at stake for failure to report properly.

Payment penalties seem unlikely. Ninety-eight percent of Medicare-certified surgery centers successfully reported in the first year of reporting, the Ambulatory Surgery Center Association says.

The ASC community asked for a quality-reporting program, says Bill Prentice, CEO of the ASCA. “We felt we had a good story to tell, and we knew the only way anyone would believe it is if we were reporting it directly to the government.”

Although the association welcomed the reporting initiative, it’s not happy with some of the measures. For the seventh measure, ASCs must report the volume of selected surgical procedures. Utilization of services, while important, doesn’t belong in a quality-reporting program, Prentice asserts.

In addition, the eighth and ninth measures deal with the appropriate follow-up interval for colonoscopies. These two measures are an indication of physician quality, not facility quality, Prentice says. “Our program should be focused on what the facilities are doing to serve patients appropriately; the quality of care they’re providing,” he says.

The expectation is the pay-for-reporting program will evolve in the near future into public reporting of ASC quality and eventually could shift to pay for performance, Prentice says.

“That’s always out there looming,” he says. “We all need to be prepared for it. Quality reporting is a good first step."


Executive Corner

The World Health Organization introduced its surgical safety checklist in 2009, created with inpatient surgery in mind. A government-funded Health Research & Educational Trust project is spreading the checklist’s use into the ambulatory surgery setting. Here are some thoughts from Bill Berry, M.D., one of the WHO checklist creators.

Hospitals that participate in the pending arm of the HRET project aimed specifically at hospital outpatient surgery departments can use checklist deployment in the ambulatory setting as a door to the inpatient surgery department’s adopting the tool. “For recalcitrant surgeons, it’s good to have a checklist in both places so, no matter where they go, they can’t hide.”

The checklist can be used as a patient-engagement tool in the ambulatory setting because patients often are under regional anesthetic. The staff can explain the checklist and its importance to the patient. “You tell them that they’ll see people reading from it, and that’s not because they don’t know what to do, but because they’re making you safe.” Checklist use can be a selling point for the facility.

Use of a checklist and effective use of a checklist are two different things. Effective use of a checklist means that the operating room team is not just checking off boxes on the list, but using it as a communication and teamwork tool.

Feedback from six ASCs in South Carolina led to slight modifications of the checklist template for ambulatory surgery providers. ASCs and hospital outpatient surgery departments should feel free to adjust the checklist to further meet their needs. “We want the facility to own it,” Berry says.