Infection Control Practices in Ambulatory Surgical Centers

Since the establishment of the first ambulatory surgical centers (ASCs) in 1970, the number of these facilities and the volume of procedures physicians perform in them have increased substantially. In parallel, during this time, there has been a marked shift to the outpatient setting for many common, low-risk operations that do not require hospitalization or a postoperative stay of more than 24 hours. Since 1991, according to the Ambulatory Surgery Center Association, more surgical procedures have been performed in the outpatient than the inpatient setting in the United States, and outpatient procedures now represent more than three-quarters of all operations performed.¹ Putative advantages of ASCs include more convenient scheduling, increased patient and surgeon satisfaction, and lower costs.¹

The number of Medicare-certified ASCs increased from 2786 in 1999 to 4506 in 2005, an average annual growth rate of 8.3%.² In 2008, ASCs numbered 5174,³ although the rate of increase of new ASCs may be moderating (6.3% annually from 2001-2008).³ Between 1999 and 2005, Medicare payments (facility fees) to ASCs increased from $1.2 billion to $2.8 billion, an annualized rate of growth of 15.3%,² reflecting a more than 3-fold increase in the number of procedures performed in the outpatient setting. Some evidence also suggests that cases of higher complexity are now being performed in the ASC setting^{4 - 5} and involving patients with greater comorbidities.⁶ However, total Medicare payments to ASCs increased by only 4.6% between 2007 and 2008 ($3 billion in 2008), in part due to a provision in the Deficit Reduction Act of 2005, which capped the ASC rate for each service at the outpatient prospective payment rate.³ Among ASCs, 61% are exclusively physician-owned, and 96% operate on a for-profit basis.¹ Today, however, the market may be saturated, and margins may be under pressure.

As important as ASCs are for provision of surgical care in the United States, relatively little is known about the quality of care at these facilities. Although ASCs are subject to the same regulatory requirements for Medicare participation as inpatient facilities for similar services provided, most aspects of monitoring of regulatory compliance are left to individual states, and direct observation has not been required. Reporting mechanisms are disjointed and extant quality-related data are sparse, particularly in the realm of postoperative infection. For instance, only 20 ASCs reported data to the National Healthcare Safety Network (NHSN) of the US Centers for Disease Control and Prevention (CDC) for 2006 through 2008, compared with data reported by 1545 hospitals.⁷

The incidence of surgical site infection (SSI) is not as low as might be anticipated following clean surgery (operations that do not enter the aerodigestive or genitourinary tracts either inadvertently or by volition). Data reported by the NHSN indicate that the median SSI rates following “herniorrhaphy” are 0.74% to 2.42% for low-risk operations and 5.25% for high-risk procedures, whereas for “breast surgery” the median SSI rates are even higher, 0.95% to 2.95% for low-risk and 6.36% for high-risk cases, respectively.⁷ The limited data from procedures at ASCs are unreliable for comparison; for example, only 7 ASCs reported data for “breast surgery” for patients with no risk factors. The literature is mixed as to whether infection rates are lower for ASCs,^{8 - 9} but the incidence is almost certainly underreported, reflecting sampling bias, patient selection, and poor compliance with voluntary reporting by surgeons of events (ie, infections) that occur long after the ASC no longer has contact with the patient.

Strict adherence to multifaceted infection control best practices is inherent to the operation of any surgical facility and the performance of any operation, regardless of magnitude or risk. Risk is adjudged in the preoperative assessment (and reduced preoperatively insofar as possible; eg, nutrition, smoking cessation). Standards for sterilization, disinfection, medication administration, and aseptic technique must be adhered to with rigor. For all personnel, proper hand hygiene is the single most effective infection control practice. Skin preparation must be meticulous for both patient and surgical team. Antibiotic prophylaxis must be timely and judicious, including nonadministration when not or no longer indicated.¹⁰

Concern about infection control practices in ASCs was heightened in 2008 with the occurrence of a major outbreak of hepatitis C virus infection that was traced to 2 Nevada ASCs.¹¹ The estimated number of potential infectious contacts exceeded 63 000, and the infections ascribed to or possibly related to the outbreak numbered 115 (9 confirmed), making this the largest reported outbreak of health care–associated infection (HAI) caused by hepatitis C in US history. During the investigation, unsafe injection practices (reuse of syringes for individual patients, reuse of single-use vials of propofol for multiple patients [despite clear language in the package insert to the contrary¹² and published reports of fatal bacteremia associated with this practice¹³ ]), and poor hand hygiene practices were directly observed. The cost of investigation, testing, counseling, and medical care for those affected was estimated between $16.3 million and $21.9 million.¹¹ Subsequently, a statewide survey of all 51 Nevada ASCs, using an infection control tool developed by the Centers for Medicare & Medicaid Services (CMS) and CDC, identified infection control lapses in 28 of them.¹⁴

In November 2009, the secretary of the US Department of Health and Human Services announced the availability of up to $9 million in funding from the American Recovery and Reinvestment Act (ARRA) for state survey agencies, targeted at reducing HAIs in ASCs.¹⁵ Several ASC-related communicable disease outbreaks (not limited to the Nevada outbreak), related to failure to use basic infection control practices, led CMS to identify HAI prevention in ACSs as an area for additional oversight. Surveyors in 43 states are surveying approximately 1300 ASCs nationwide using the CMS/CDC infection control tool.¹⁵

In this issue of JAMA, Schaefer et al¹⁴ report the further use of the infection control tool by CDC-trained state surveyors as part of full, unannounced assessments of randomly selected ASCs in Maryland (n = 32), North Carolina (n = 16), and Oklahoma (n = 20). Staff were notified that an inspection was being conducted. Identified deficiencies were reported to ASCs by CMS, and seriously noncompliant facilities faced reinspection and possible sanctions for failure to address and correct all deficiencies, including termination of the facility from Medicare participation. Overall, nearly 68% of ASCs had a lapse of infection control practices noted under direct observation (18% in ≥3 domains). More than 19% had observed lapses in hand hygiene and use of personal protective equipment (eg, gloves). More than 28% of ASCs were observed to have lapses in injection safety and medication handling, including single-dose medications used for more than 1 patient. Additionally, errors of equipment reprocessing were observed in 28% of facilities, of environmental cleaning in 18% of ASCs, and of blood glucose monitoring in nearly one-half. Fifty-seven percent of surveyed ASCs were cited ultimately for deficiencies in infection control.

The Hawthorne effect, although perhaps given more credence by generalists than professional social scientists,¹⁶ suggests that knowingly being observed can improve task-oriented performance, even if only transiently (as in the case of a relatively brief ASC facility inspection). Poor performance or compliance with even the basics of infection control while aware of being under direct observation becomes all the more astonishing in context. Moreover, strikingly similar observations between the Nevada ASC’s infection control practices and the results reported by Schaefer et al¹⁴ suggest that these problems may be pervasive. If the findings by Schaefer et al are generalizable, then among the estimated more than 6 million patients who undergo procedures in ASCs annually in the United States,¹⁵ it is possible that several million patients could be at potential risk for HAI each year. This risk is not acceptable and must be corrected immediately and definitively.

Federal regulatory intervention is already occurring.¹⁵ Ambulatory surgical centers must now maintain infection control programs directed by a designated health care professional with training in infection control, and audited adherence will be conducted through a modified infection control tool, but programmatic sustainability after fiscal year 2010 is not assured when ARRA funding expires. Regardless, ASCs and practitioners are not absolved of individual and collective responsibility to do the right thing.

In 1847, when Ignaz Semmelweis was employed as assistant (analogous to today's chief resident) to the professor of the maternity clinic at the Vienna General Hospital, he introduced hand washing with chlorinated lime solutions for interns who had performed autopsies. This immediately reduced the incidence of fatal puerperal fever (postpartum endometritis, caused by Streptococcus pyogenes) by 80% to 90%, from about 10% to about 1% to 2%.¹⁷ Semmelweis' hypothesis, that there was only 1 cause of infection and that all that mattered was cleanliness, was extreme at the time and was widely rejected (and ridiculed). Dismissed from the hospital and ostracized and harassed by the medical community in Vienna, he was forced to move to Budapest. Outraged, he authored a series of open and increasingly angry letters to prominent European obstetricians, causing his mental state to be questioned. He died in 1865 within days of being committed to an asylum.¹⁸

Semmelweis' meticulously documented observations,¹⁷ a classic of applied science, only earned widespread acceptance years after his death, after Louis Pasteur developed the germ theory of disease and Sir Joseph Lister demonstrated the effectiveness of surgical antisepsis with a spray of carbolic acid (phenol). With the approach of the sesquicentennial of Semmelweis' death, perhaps the lessons of his personal tragedy can be taken to heart to remedy this tragic systems failure. It is not difficult to imagine how Semmelweis, Pasteur, Lister, and William Stewart Halsted (who, among many accomplishments, introduced rubber gloves to surgical attire) would respond to learning of the unacceptable infection control practices in ASCs.