Infection Connection

CS departments feel heat from regulatory, liability pressures

by Julie E. Wilaimson

It isn’t easy being a sterile processing professional. While that statement is hardly a revelation, it seems especially accurate in today’s challenging climate. Not only are sterile processing personnel being plagued by age-old indignations that never seem to go away, such as lack of respect, inadequate staffing levels and insufficient support for ongoing education, today’s central service professionals are also being saddled with more responsibility and the unrelenting pressure that comes with having to do more with less. 

Adding to the burden, CS departments are facing more regulatory scrutiny than ever, and are struggling to stay abreast of evolving standards aimed at promoting quality and patient safety and limiting liability related to sterile processing duties – all the while being asked to meet the demands of increased caseloads and faster turnaround times, despite mounting resource constraints.

“It’s never been an easy job, but there are now so many factors weighing on CS that are making the job even more difficult,” 
said Charles Hancock, president, Charles O. Hancock Associates, Fairport, NY. 

Unfortunately, when inspectors come knocking, those trying circumstances he refers to are rarely taken into consideration. In fact, more than ever, inspectors are expecting all departments – including sterile processing – to show they are following current standards of practice, documenting their tasks, and establishing and adhering to policies and procedures that limit patient risk and improve overall quality. 

Raising red flags
Since the release of the seminal 1999 report on medical errors from the Institute of Medicine, all eyes have been on healthcare practices and so-called preventable mistakes. And CS has certainly been no stranger to controversy and glaring headlines. 

Over the last year, disinfection and sterilization practices have come under fire amid reports of patient infections stemming from contaminated instruments. Two pulmonary patients at Baltimore’s Johns Hopkins Medical Center, for example, died of pneumonia allegedly after being exposed to bronchoscopes that were recalled months prior to the procedures, and 100 others tested positive for Pseudomonas aeruginosa. Although a design flaw in the scopes was partially blamed for the infections, improper maintenance of an automatic endoscope reprocessor also came into question. As a result, the Joint Commission on Accredi-tation of Healthcare Organizations issued a Sentinel Event Alert warning of the incidents and recommended practices to reduce the like-lihood for cross-contamination during procedures. 

Of course, along with that Sentinel Event Alert came a sharper focus by inspectors on processing protocols. JCAHO inspectors, who may not have ventured down to CS departments in the past other than for routine “walk-through” visits, are now taking a much greater interest in policies and procedures aimed at reducing cross-contamination and improving overall sterile processing practices.

“We are looking to see that departments are following hospital policies and procedures, as well as whether standards of practice are up-to-date and being used as the basis for those policies and procedures,” said Patricia Staten, associate director of standards interpretation for JCAHO. “Facilities that can’t show us their practices are being guided by policies and procedures based on those standards and recommendations may face [deficiencies].”

One sterile processing director said she’s felt the pressure mount in recent years in light of problems her department had with inadequately cleaned instruments that may have led to patient infections – problems that in some cases resulted in costly lawsuits. Although the cases were settled out of court and no CS staff member had to testify, she said she remains on her toes and is “very concerned” about the possibility of future problems and citations, despite her department’s hard-fought efforts in improving practices and preventing similar events from occurring.

One industry consultant believes such concerns are justified. C. Kay Watson, a Houston-based sterile processing consultant, said the IOM study and a more educated, “aggressive public” have boosted the chances of CS professionals being called to testify as witnesses in court. Although the facilities, not workers, will usually be named as defendants, it’s understandable that CS professionals feel that they are under even greater pressure than before, she said. 

The FDA steps in
Some CS departments can expect even more pressure, particularly if they remain involved in reprocessing single-use devices. The Food and Drug Administration has already begun inspecting facilities that earlier registered their reprocessing practices with the agency, and the agency is poised to pay visits to those facilities suspected of engaging surreptitiously in that controversial practice.

According to Larry Spears, the FDA’s acting director of the office of compliance, Center for Devices and Radiological Health, hospitals officially registered as reprocessors are already undergoing FDA inspections, and that the agency plans to inspect “many more throughout 2003.” While the FDA had considered using JCAHO or state surveyors as outsourced third-party inspectors, the agency has for now decided to tackle the process itself, Spears added. And if an FDA telephone survey is any indication, more hospitals may be facing inspections than one might expect. 

According to that survey, 24 percent of hospital respondents said they reuse SUDs that have been used on patients, with the most commonly reused SUDs being sequential compression devices, drill bits, saws, blades or burrs, biopsy forceps and snares, endoscopic accessories, such as scissors or graspers, and electrophysiology catheters. The survey also revealed that large hospitals (those with more than 250 beds) are more likely to reuse SUDs than smaller facilities, and that 84 percent of hospitals that reuse rely on the services of a third party reprocessor. That would leave about 16 percent who engage in that practice themselves.

Another aspect of reprocessing under the regulatory microscope is the practice of reprocessing opened but unused single-use medical devices – a somewhat gray area the FDA has so far excluded from its regulation. In August 2002, the FDA requested comments on the practice to determine whether hospitals should have a written policy or procedure for handling sterile SUDs that are opened but unused, how hospitals determine whether an SUD that has been opened but unused is contaminated, and which types of SUDs are resterilized because they are opened but unused.

A membership survey conducted collaboratively by the American Hospital Association, the American Society for Healthcare Central Service Professionals and the Association for Professionals in Infection Control and Epidemiology revealed that approximately 25 percent of hospital respondents resterilize the devices, and most either have their own written policies and procedures for handling opened but unused SUDs or rely on the policies of third-party reprocessors. 

Of hospitals that resterilize the items, more than half (56 percent) rely on third-part reprocessors, with only 16 percent engaging in the practice in-house. No respondent indicated an adverse patient outcome as a result of using the opened but unused SUDs. What’s more, the survey data indicated that very few hospitals would resterilize devices opened within a sterile field and which there was visible contamination. In fact, it showed “most hospitals are willing to resterilize only devices that were opened outside the sterile field or within a sterile field without visible contamination,” according to a letter commenting on the survey results from the American Hospital Association to the FDA. 

The FDA has yet to issue a definitive decision on reprocessing opened but unused SUDs, but the agency has fielded many comments from groups like the FDA, ASHCSP and APIC, among others, that urge against regulating the practice.

More standard guidance
Sterile processing departments have more issues to follow than reuse. A number of standards revisions are either on the table or the drawing board, and guidance documents new to the practice of disinfection and sterilization are on the horizon. 
Although many CS professionals may not necessarily view additional standards as a positive development, particularly because they often struggle to stay on top of standards already in place, sources assured many of these standards could actually ease some of the burdens common to the department.

In January, AAMI announced it had approved a new national standard for hospital steam sterilization, which not only provided everyday guidance for performing steam sterilization in hospitals, but also includes new, detailed information on integrating 
chemical and biological indicators with enzyme-based early-readout capability. The association is also in the process of developing a compilation steam sterilization document that groups all standards in one place, reduces redundancies and includes the most current information related to the practice.

“It’s often difficult for the user community to keep up with all the individual documents, so this resource should really come in handy,” explained Judith Veale, J.V. Biomedical Consultants, Rehoboth, MA, adding that AAMI intends to some day have one document for all methods of sterilization, from steam and ethylene oxide to dry heat and chemical sterilants. Veale said the steam sterilization document should be completed within the next two years.

For the first time ever, CS professionals will also have available a guidance document specific to disinfection and sterilization from the Healthcare Infection Control Practices Advisory Committee. The document, authored by Professor William A. Rutala of the University of North Carolina Healthcare System in Chapel Hill, will function as detailed performance guidelines for sterile processing staff by expanding and updating the now-antiquated 1995 APIC guidelines for disinfection and sterilization, and will outline new types of sterilization methods and best practices. 

“This document will be important for several reasons. First of all, it will provide much-needed guidance that is current and more detailed than [documents] of the past,” explained consultant Robert Sharbaugh, Ph.D, CIC, of ICP Associates, Charleston, SC. “Surveyors will also be looking at the HICPAC document from an infection control standpoint and expecting facilities to be using the guidance as a basis for their policies, procedures and practices.”

 Sharbaugh said the document will feature detailed information related to Creutzfeldt-Jakob disease and may even include information on the newly discovered lethal respiratory illness Severe Acute Respiratory Syndrome or SARS. 

CS staffers may not, however, welcome one guidance document that appears to be picking up steam. According to Sharbaugh, who sits on some AAMI standards committees, the issue of microbial biofilms – otherwise known as trace elements and endotoxins that develop as a result of poor water quality – is gaining attention from industry associations. Although AAMI currently does not address biofilms in its current standards he said a draft form is in the works which aims to more carefully define proper water quality in the context of reprocessing reusable devices. 

Biofilms will become a very big issue in CS because a standard will require a lot of [steps] for CS to go through, such as culturing and testing of the water at least weekly,” he said, adding that such a standard is “at least a year down the road.”

On the record
Regardless of any new standards or regulations that surface, one thing remains certain: sterile processing departments will have to keep meticulous records of their processes if they want to stay out of trouble with inspectors and help clear themselves in the event of an adverse outcome or lawsuit.

“Documentation of processes is absolutely critical because in the inspector’s eyes, if it isn’t documented, you didn’t do it,” said Sharbaugh.

David Wise, a processing technician at Saint Mary’s Health Services, Grand Rapids, MI, agreed, adding that his facility is carefully documenting, tracking and identifying loaner instrumentation that comes from other facilities to ensure that sets and trays have enough time to be sterilized prior to a procedure. “Flash sterilization is something we’re really trying to get away from. The JCAHO is looking more closely at that and wants to see whether facilities have policies and procedures in place to minimize [the practice].” 

According to Staten, inspectors are also looking for – and encouraging – more productive relationships between CS, the OR and infection control. While there’s no decree that facilities must have a more coordinated effort, the Joint Commission does require facilities to designate an infection control coordinator and include disinfection and sterilization processes in overall infection control efforts.

“We like to see who’s involved in the process and encourage working together as a team,” Staten noted. “Cleaning and sterilization need to be included in the infection control process.” 

HPN

May