Centers come under tighter scrutiny for infection control practices
Desktop sterilizer that have had no preventive maintenance and calibration, and no spore tests are being done to ensure sterility. Anesthesia staff members who use a manifold device connected to the IV drugs, and the tubing from the manifold to the patient's IV is not changed between patients. Drugs hanging all day, unlabeled. Instruments soaked in glutaraldehyde and then put into the autoclave, which needlessly exposes staff to chemical fumes in an unventilated room. Endoscopes not thoroughly cleaned before soaking, soaking in a solution that was not checked for potency before each use, and scopes that are not leak tested.
These "horror stories" from ambulatory surgery centers (ASCs) point to the need for a specialist in infection control at the facilities, says Marcia Patrick, RN, MSN, CIC, director, infection prevention and control, MultiCare Health System in Tacoma, WA. Patrick is a board member for the Association for Professionals in Infection Control and Epidemiology (APIC).
"The growing number and complexity of minimally invasive procedures and the procedures that are now done in the outpatient setting have led to a need for the same kind of infection prevention oversight that is found in most hospitals," Patrick says. The risks are significant, she says, and in many states there aren't any regulations.
"Physicians can hire someone off the street and teach them to clean scopes or do anything else with no formal training," Patrick says. Physicians often aren't experts in cleaning, disinfection, and sterilization, she maintains. "This is a specialty area that requires a specialist's attention," Patrick says.
There is a growing tide of similar sentiment from government groups, national associations, and researchers. A just-published review of outbreak information revealed 33 outbreaks of hepatitis B virus (HBV) and hepatitis C virus (HCV) in nonhospital health care settings in the past decade, which the authors say is the "tip of the iceberg."1 The study, published in the Annals of Internal Medicine, reported 12 outbreaks in outpatient clinics, including an ambulatory surgery center, multiple endoscopy clinics, and two physician practices. There were six outbreaks in hemodialysis centers and 15 in long-term care facilities. The final result of these outbreaks was 448 people acquiring HBV or HCV infections. The cause? Patient-to-patient transmission through failure to adhere to fundamental principles of infection control and aseptic technique, such as reuse of syringes or lancing devices, the authors say.
"Difficult to detect and investigate, these recognized outbreaks indicate a wider and growing problem as health care is increasingly provided in outpatient settings in which infection control training and oversight may be inadequate," the authors wrote. "A comprehensive approach involving better viral hepatitis surveillance and case investigation, health care provider education and training, professional oversight, licensing, and public awareness is needed to ensure that patients are always afforded basic levels of protection against viral hepatitis transmission."
States are targeted
The concern at the national level is manifesting itself in tighter scrutiny during state surveys. A total of 68 ASCs in Maryland, North Carolina, and Oklahoma participated in a pilot test during summer 2008 that expanded surgery center surveys with changes to the infection control tool. [See copy of the draft infection control survey instrument.] A final report is expected this fiscal year, according to sources at the Centers for Medicare & Medicaid Services (CMS).
The draft tool was intended to allow inspection of basic infection control practices that were not specifically addressed by routine surveys, sources say. "We wanted to get a sense of whether the types of issues that we saw in Nevada might be more generally prevalent in ASCs in other parts of the country," says a CMS official, who isn't identified according to department policy. "At the same time, we also wanted to pioneer some innovations or refinements in our survey methodology to ASCs and evaluate those to see whether those ought to be incorporated permanently, according to our guidance on the survey process for ASCs."
Surveyors in those states were instructed to follow one case from start to finish, if possible, the official says. Surveyors also followed equipment through the sterilization process, says Barbara Fagan, program manager, Office of Health Care Quality within Department of Health and Mental Hygiene in Maryland. Maryland already has adapted CMS' infection control tool in its state survey process, she says.
New survey tool to go nationwide?
Joseph F. Perz, DrPH, MA, health care epidemiologist, team leader, prevention activities, Division of Healthcare Quality Promotion at the Centers for Disease Control and Prevention (CDC), says, "Given the increasing attention, higher expectations in this area, it wouldn't surprise me if we saw broader application of that kind of tool, or including that kind of content in surveys, moving forward." Perz is one of the authors of the recent study in the Annals of Internal Medicine.
As if all of this increased scrutiny wasn't enough to get the attention of outpatient surgery managers, the Oklahoma State Department of Health reports that there is a billboard displaying the words, "Hepatitis C? Call law firm" with the lawyers' phone number listed.
Is such a billboard an indication that hepatitis outbreaks are not isolated incidences? "Some of the misperceptions and practices in question are more widespread than we would have expected," Perz says. "Nonetheless, it really is a wake-up call for us to address this before you have one. We want patients to have confidence in the care they're receiving."
- Thompson ND, Perz JF, Moorman AC, et al. Nonhospital health care-associated hepatitis B and C virus transmission: United States, 1998-2008. Ann Int Med 2009; 150:33-39.
National groups take a closer look at infections
The Government Accountability Office (GAO) has conducted a nationwide study to determine what role ambulatory facilities play in the spread of health care-acquired infections (HAIs). At press time, the study was expected to be completed by February.
If the GAO determines that ambulatory facilities play a role in the spread of infections, many changes may be forthcoming, says Kathleen B. Stoessel, RN, BSN, MS, senior manager, clinical education at Kimberly-Clark Health Care, Atlanta. "These changes might include more stringent infection prevention oversight; emphasis on staff training, compliance monitoring, government reporting of HAIs; impact on reimbursement from [the Centers for Medicare & Medicaid Services] and private insurers; and pay-for-performance mandates," she says.
Also at the national level, the Steering Commission for Prevention of Healthcare-Associated Infections, part of the Department of Health and Human Services (HHS), has been formed to address the concerns raised in a 2008 GAO report that criticized HHS for "needless suffering and death" caused by health care infections. The Commission will work with the Healthcare Practices Advisory Committee (HICPAC) at the Centers for Disease Control and Prevention (CDC). The committee is charged with developing an HHS action plan to reduce HAIs, including the development of prevention guidelines, data collection and analysis, and outreach and education. The committee will concentrate on the leading HAIs, including surgical-site infections.
Additionally, The Joint Commission and all the major infection prevention associations are creating a compendium that is essentially a synthesis of established prevention guidelines to prevent the major HAIs. Also, under the 2009 National Patient Safety Goals, ambulatory surgery programs will be required to implement best practices on prevention of surgical-site infection.
2 more incidents raise questions
Are you handling scopes correctly?
There's another investigation under way to determine whether patients might have been exposed to infection from colonoscopies at the York Veterans Administration (VA) Hospital in Murfreesboro, TN.
One volunteer who said she's seen instruments delivered in the women's and dental clinics for 20 years, was quoted in a news report as saying they're often dirty.1 She said they were supposed to have been sterilized more than 30 miles away.
There are two ways to clean and disinfect the scopes used for colonoscopies: manually and with an automated reprocessor, says Marcia Patrick, RN, MSN, CIC, director, infection prevention and control, MultiCare Health System in Tacoma, WA. Patrick is a board member for the Association for Professionals in Infection Control and Epidemiology (APIC). "In both cases, the scope must be manually wiped off externally, then the lumens — scopes are tubes within a tube — scrubbed with a brush and an enzymatic cleaner to physically remove all the debris," she says. "This step is critical."
In another incident, Nevada officials have completed an investigation of a Las Vegas outpatient surgery center after the center reported improperly setting machines to reprocess endoscopes.
"The facility self-reported that its automatic endoscope reprocessor had been incorrectly set at one minute vs. the manufacturer's recommended time of five minutes," says Marla McDade-Williams, MPH, bureau chief of the Bureau of Health Care Quality and Compliance, State Health Division, in Carson City. Because the facility self-reported, there will not be any sanction, but the bureau released a formal statement of deficiencies that said the facility failed to ensure employees followed the equipment manufacturer's instructions and failed to ensure employees received annual training on the instructions.
In an unrelated incident publicized last year in Las Vegas, public health officials urging about 50,000 patients to be tested for hepatitis C virus (HCV), hepatitis B virus, and HIV. The practices under investigation then included alleged reuse of syringes and re-entry into single-dose vials of pain medication for different patients undergoing colonoscopies. Nine HCV infections have been linked to the outbreak, and another 101 are being investigated as possible cases.
A state law has been proposed in Nevada to include periodic inspections by infection prevention consultants. "The proposal is to require the bureau to conduct some type of review process at doctor's offices where certain levels of sedation are performed," says McDade-Williams.
To avoid problems, ensure that you are following manufacturing guidelines for reprocessing of equipment, such as endoscopes, says Joseph F. Perz, DrPH, MA, health care epidemiologist, team leader, prevention activities, Division of Healthcare Quality Promotion at the Centers for Disease Control and Prevention (CDC). Don't reprocess or reuse equipment if you don't have the equipment to do it properly, he says.
Also, check the soak time each time an item is placed in the processor, Patrick
Be proactive, Perz says. "Be able to say, 'We have checks in place. We're doing everything correctly in terms of reprocessing equipment and using equipment the way it was intended,'" he says.
- Lambert D. VA Volunteer calls hospital tools dirty, sterilization occurs more than 30 miles from hospital. WSMV-TV. Jan. 5, 2009. Accessed at http://www.wsmv.com/health/18401863/detail.html.
Educate, train, and ensure it translates into practice
One of the critical steps to avoiding health care-acquired infections is to educate and train staff.
All staff must know the principles of asepsis, cleaning, disinfection and sterilization processes, hand hygiene, and instrument management, says Marcia Patrick, RN, MSN, CIC, director, infection prevention and control, MultiCare Health System in Tacoma, WA. Marcia is a board member for the Association for Professionals in Infection Control and Epidemiology (APIC).
Injection safety is an overlooked area, says Joseph F. Perz, DrPH, MA, health care epidemiologist, team leader, prevention activities, Division of Healthcare Quality Promotion at the Centers for Disease Control and Prevention (CDC). Perz recently published a study on hepatitis outbreaks in the Annals of Internal Medicine.
"Where we've seen problems include reuse of medications or flush solutions that are intended for single-patient use," Perz says. Examples include a single-use vial of propofol, he says. "Some providers don't realize that's provided in a vial that is not actually a multidose vial," he says. "Even though you can order a large vial, and it may look outwardly like your other multidose vials, it's not."
Additionally, some providers use bags of saline solution for multiple patients, which is a risky practice, he says. "If microbes are introduced, there's a growth opportunity," Perz says.
Multidose vials also are a concern, he says. "The risks we identified in many outbreaks were related to health care workers going back to a vial with a syringe that already had been used," Perz says. Often providers needed an additional dose for a patient, but they don't realize that they could be contaminating the vial, he says. "Subsequent patients could be exposed to hepatitis C or other bloodborne pathogens," Perz adds.
Review practices at your facility to ensure such practices aren't happening, he says. Train new employees in standard precautions, including injection safety, and review infection control procedures at least annually thereafter, Perz advises. (An infection control Q&A is included.)
Establish a mechanism through which anyone can report a concern, Patrick says, "and know that there is someone who is looking at these to ensure all the items needed for safe care are available, that staff and patients are safe."
Take the next step, says Kathleen B. Stoessel, RN, BSN, MS, senior manager, clinical education at Kimberly-Clark Health Care, Atlanta. Stoessel says "knowledge does not necessarily lead to compliance with recommended guidelines and best practice policies and procedures. Therefore, ongoing monitoring of actual practice and embedding reliability of performance within the system are critical to ensure adherence to evidence-based care."
One of the reasons that problems have cropped up in ambulatory care is that inspections are often inadequate or nonexistent, Patrick maintains. When Patrick first started working in infection control, she had to learn every step of the process. "I learned to look for a small metal pipe with four to six nipples coming off the cold water supply pipe in the soiled utility room," she says., "That meant the staff was flushing and reusing cardiac catheters to save money." These catheters are labeled "single patient use," Patrick says.
"With no oversight, staff can be doing anything," she emphasizes. "Most are not willfully trying to hurt someone, but bad practices are very dangerous."
Have someone responsible for ensuring daily cleaning and disinfection is occurring and that every item has a designated person to clean and disinfect it, Patrick says. Managers should meet with the janitorial service and be very clear about who is responsible for cleaning each item, she says.
"Often, ambulatory staff think the janitorial service is cleaning and disinfecting exam tables, gurneys, countertops, etc., when all they are really doing is emptying trash, mopping floors, and vacuuming rugs," Patrick says.
Educational resources are abundant, sources say
Use materials as basis for policies
When looking at infection control resources, the "foundation for infection prevention" is the standard precautions from the Centers for Disease Control and Prevention (CDC), says Joseph F. Perz, DrPH, MA, health care epidemiologist, team leader, prevention activities, Division of Healthcare Quality Promotion at the Centers for Disease Control and Prevention (CDC). (Editor's note: These precautions are available at www.cdc.gov/ncidod.)
"No matter what setting you're in, these are essentially universal recommendations," Perz says. This document could be the basis for educational materials and outreach, he says.
Also, the Association for Professionals in Infection Control and Epidemiology (APIC) has infection preventionists available for consulting, Perz points out. (Editor's note: This information is available at www.apicconsulting.com.)
"Strong collegial relationships with other facilities in the community to discuss best practices, to look at quality measures, and to ensure best practice are also helpful," Perz says.
Have written policies and procedures that comply with those from national organizations, including the CDC, says Marcia Patrick, RN, MSN, CIC, director, infection prevention and control, MultiCare Health System in Tacoma, WA. Patrick is a board member for the Association for Professionals in Infection Control and Epidemiology (APIC). Policies must include the following, she says:
- management of patients and staff with an infectious condition;
- operation of sterilizers;
- cleaning of instruments;
- high-level disinfection;
- medication management;
- storage of sterile and nonsterile supplies;
- sharps safety and management of sharps;
- infectious waste;
- hand hygiene;
- dress code;
- employee screening requirements.
Always be mindful of your state requirements, Perz adds.
The following infection control resources are available from the Centers for Disease Control and Prevention (CDC):