Sacred Obligation: Restoring Veteran Trust and Patient Safety

May 3, 2011

Testimony Before the Committee on Veterans Affairs U.S. House of Representatives

Good morning Chairman Miller, Ranking Member Filner and other distinguished Members of the Committee. I am Dr. Michael Bell, Deputy Director of the Division of Healthcare Quality Promotion at the Centers for Disease Control and Prevention (CDC). I am pleased to be here to discuss the prevention of healthcare-associated infections (HAIs) and ensuring safe healthcare nationwide.

Healthcare associated infections are infections that patients acquire while receiving care. They include a variety of infections ranging from those related to specialized intensive care procedures to infections caused by lapses in basic safe practices, like re-using disposable syringes or inappropriate reprocessing of equipment. CDC estimates that approximately 1 in 20 hospital patients have HAIs. These infections are associated with increased mortality and greater cost of care; and can occur in any healthcare setting -- hospitals, long-term care, dialysis clinics, ambulatory surgical centers, and even doctors’ offices. As complex care is increasingly delivered in non-hospital settings, we are seeing a concomitant increase in potentially life-threatening infections related to care outside of hospitals. Infections caused by lapses in basic infection control are unacceptable. We know how to protect patients from these events; they can and must be prevented.

Based on CDC data, the four most frequent infections related to specialized care procedures accounting for approximately three quarters of HAIs are: 1) urinary tract infections; 2) surgical site infections; 3) bloodstream infections; and 4) pneumonia. These infections are caused by both common pathogens such as Staphylococcus aureus, including Methicillin-resistant Staphylococcus aureus (MRSA), and by emerging pathogens such as drug-resistant Klebsiella pneumoniae. In addition, we continue to see egregious failures in basic infection control and safety practices (e.g., using the same syringe to administer medication to more than one patient) that have resulted in transmission of bloodborne and other pathogens (i.e., hepatitis C virus, [HCV], hepatitis B virus [HBV]). HAIs in hospitals alone result in excess healthcare costs of an estimated $26 to $33 billion each year. Yet, most HAIs are preventable. HHS and its public and private sector partners are working together to eliminate these costly and deadly infections. HHS recently launched the Partnership for Patients: Better Care, Lower Costs, a new public-private partnership that will help improve the quality, safety and affordability of health care for all Americans. The Partnership for Patients brings together leaders of major hospitals, employers, health plans, physicians, nurses, and patient advocates along with State and Federal governments in a shared effort to make hospital care safer, more reliable, and less costly.

The Centers for Disease Control and Prevention, working with several other agencies in the U.S. Department of Health and Human Services, has taken a lead role in addressing the important public health challenge of preventing HAI’s by identifying and implementing prevention strategies, providing guidelines for prevention, monitoring HAIs and tracking prevention progress, and detecting and responding to emerging threats.

The HHS Action Plan to Prevent HAIs sets specific targets for monitoring and preventing HAIs nationally and represents a national blueprint for promoting HAI prevention. CDC has played an integral role in the HHS led effort to develop and implement the HHS Action Plan, including chairing the Prevention and Implementation working group and co-chairing the Information Systems and Technology working group. Since the release of the initial HHS Action Plan, CDC has collaborated closely with the HHS Assistant Secretary for Health, the Agency for Healthcare Research and Quality (AHRQ), the Centers for Medicare and Medicaid Services (CMS), the Department of Veterans Affairs (VA), and other federal agencies to expand and implement the HHS Action Plan to include ambulatory surgical centers and hemodialysis centers.

There has been significant progress in several areas; however more work is needed to ensure that appropriate infection control practices are adhered to in all healthcare settings. The VA has been an important partner in implementing HHS HAI prevention initiatives. However, recent infection control lapses, such as those at VA facilities in Dayton OH, St. Louis MO, and Miami FL, demonstrate the need for constant vigilance.

Today, I will focus my remarks on 3 specific areas: 1) the issue of basic infection control in healthcare, including CDC’s efforts to prevent them; 2) CDC’s collaborations with the VA related to HAIs; and 3) recommended strategies to halt improper practices when they are identified and to notify patients that were exposed to those practices.

Healthcare-Associated Infections Related to Failure to Maintain Basic Infection Control

CDC has worked with state and local health departments to identify numerous breaches in basic infection control practices in recent years. Infections acquired through lapses in basic infection control practices are generally through an intermediate device or material. A medical device (e.g., syringe, needle, lancet) or medication becomes contaminated with an infectious agent and the infectious agent is then passed to a previously uninfected patient through inappropriate exposure to the contaminated material. Examples of improper practices include:

• Using the same syringe to administer medication to more than one patient;
• Accessing a shared medication vial with a syringe that has already been used to administer medication to a patient; and
• Performing finger stick blood sampling with a reused lancing device or checking blood glucose levels with a blood-contaminated glucose meter.
• Improper reprocessing (i.e., cleaning and disinfection) of endoscopes
• Improper reprocessing and sterilization of medical equipment (e.g., surgical equipment)
• Improper reuse of medical devices (e.g., syringes, prostate biopsy needle guides)

These unacceptable practices put patients at risk of infectious and non-infectious adverse events and have been associated with a wide variety of procedures. Unfortunately, these practices are occurring across the healthcare spectrum and in non-acute care settings outside of hospitals, where infection control capacity is often less extensive and oversight more limited.

Healthcare should never be a conduit for transmission of infections. Basic infection control practices have long been established as part of the evidence-based and common sense precautions that are necessary to prevent transmission of pathogens.

CDC’s Efforts to Prevent HAIs Due to Failure to Maintain Basic Infection Control

Leading the nation’s efforts to protect patients from transmission of pathogens due to lapses in infection control during healthcare delivery, CDC is engaged in a number of efforts to eliminate these events, including:

• development and implementation of HAI prevention guidelines,
• development of survey tools to evaluate facilities’ adherence to infection control practices,
• identifying and responding to new and emerging threats to patient safety,
• educating healthcare providers and patients in basic infection control, and
• promoting development of safer medical devices.

Development and Implementation of Infection Prevention Recommendations

CDC, working with the HHS Healthcare Infection Control Practices Advisory Committee (HICPAC), develops evidence-based guidelines for HAI prevention. Key existing guidelines include: (1) the Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, presenting evidence-based recommendations on the preferred methods for cleaning, disinfection and sterilization of medical equipment and for cleaning and disinfecting the healthcare environment, (2) the Guidelines for Environmental Infection Control in Health-Care Facilities, 2003, a compilation of recommendations for the prevention and control of infectious diseases that are associated with healthcare environments, and (3) the 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings. CDC and HICPAC also developed summary recommendations specifically for ambulatory care targeting basic infection control practices that should be used in all healthcare settings. CDC has worked with professional associations to reach out to healthcare professionals and is collaborating with CMS to incorporate CDC guidelines into CMS practice requirements.

Tools to Improve Basic Infection Control

CDC develops tools to translate CDC and HICPAC guidelines into practice. For example, CDC is improving basic infection control practices through collaborations with CMS to expand survey and oversight capacity of non-acute healthcare settings. CDC and CMS worked together to develop a new tool that state inspectors can use to better ensure the quality of care in ambulatory surgical centers (ASCs); use of the tool has been expanded nationwide. In a 2008 federal survey of ASCs, 68 percent of 68 surveyed had noncompliance with the infection control requirements in the Medicare ASC health and safety standards. CMS has found infection control problems in ASCs to be both common and egregious, ranging from failure to clean equipment between patients and re-use of single-dose vials of medication for multiple patients. CDC is working with CMS to expand incorporation of basic infection control content into CMS interpretive guidance for their conditions of coverage. The tool has now been adapted for use in nursing homes and used to assess infection control practices in Nevada nursing homes. CDC continues to work with CMS to develop similar tools for use in acute care and other healthcare settings.

Breaches in basic infection control practices have put greater focus on the authorities and role of state and local health departments in ensuring patient safety. State licensure boards can promote ongoing training and certification as a part of licensure requirements for healthcare professionals. State health departments play critical public health roles in preventing harm due to incorrect practices, including issuance of cease and desist notices when necessary.

Identifying and Responding to New and Emerging Threats

CDC serves as a national and global leader in the investigation and control of HAI outbreaks. Through its investigations, CDC identifies problems, develops new prevention strategies, and works with partner agencies such as the Food and Drug Administration (FDA) to implement policy changes. Investigation of single suspect cases has in many instances led to the detection of sizable outbreaks, highlighting the point that recognized outbreaks are usually only the tip of the iceberg. Outbreaks often reveal unsafe practices and can require large scale patient notifications (as described below). Countless infections were prevented because of interventions that were implemented in collaboration with FDA and other partners to stop these outbreaks, including the identification and recall of contaminated or defective products, changes in device construction, revised recommendations for device use, closure of non-compliant facilities, and recommendation of new practices to prevent additional infections.

CDC deploys experts including healthcare epidemiologists, infectious disease physicians, and laboratory scientists to assess healthcare settings, collect and analyze data, evaluate practices, and perform microbiologic testing in response to a recognized outbreak or problem. CDC has assisted with laboratory testing of patients put at risk for hepatitis. Information from these investigations not only serves to control the immediate problem, but also has a direct impact on future HAI prevention nationwide. Experience from outbreak investigations also contributes to refinement of infection control guidelines and improvements in HAI tracking.

Viral hepatitis is a reportable condition in all states, but our ability to detect transmission in healthcare settings through this routine surveillance is limited because the system relies on passive reporting and in many cases we cannot evaluate how patients became infected. Therefore, CDC provides funding to several states to conduct enhanced viral hepatitis surveillance through the Emerging Infections Program (EIP). A case control study was conducted as part of the EIP activity to examine the role of healthcare exposures among older adults with acute hepatitis B and C. Results of this study indicate that viral hepatitis infections transmitted to individual patients in healthcare settings represent a significant but under-recognized problem.

Promotion of Infection Control through Education

CDC is working with partners through the Safe Injection Practices Coalition (SIPC), a partnership of healthcare-related organizations, professional organizations, and patient advocacy groups, that promote safe injection practices in healthcare settings. Through CDC funding, the SIPC developed the One & Only Campaign—a public health education and awareness campaign —aimed at both healthcare providers and patients to advance and promote safe injection practices and implemented the campaign in Nevada, New York, and New Jersey. In addition, CDC has disseminated almost 5,000 DVDs and logged over 20,000 online views of a 10 minute educational video for healthcare providers on safe injection practices launched in collaboration with the SIPC.

Promoting Development of Safer Medical Devices

CDC is working to promote innovation and development of product and marketing improvements to protect patients. For example after the identification of several outbreaks of viral hepatitis resulting from shared use of fingerstick (lancing) devices and point of care blood testing devices for glucose monitoring, in August 2011, the FDA, CDC, and CMS issued clinical reminders and public health notifications highlighting the risk of transmission of disease from these devices. FDA is working with manufacturers to ensure that adequate labeling and instructions for use are provided to healthcare personnel so that they can adhere to recommended practices.

CDC’s Collaborations with the VA to Prevent Infections

CDC’s efforts to eliminate HAIs are amplified through close collaborations with a range of federal agencies, including the VA. The VA has been directly involved with CDC in many of the efforts outlined above. A senior representative from the VA serves as an ex-officio member of HICPAC, and as such is engaged in the ongoing development of infection prevention guidelines and strategies for surveillance and prevention of HAIs. The VA is also engaged in HHS inter-agency initiatives to improve and expand HAI prevention efforts, including the HHS Steering Committee for the Prevention of Healthcare-Associated Infections, of which the VA is an active member. CDC has worked with the VA in the investigation and response to lapses in basic infection control at VA medical facilities.

The VA hospital system has been a leader in implementing CDC and HICPAC infection prevention recommendations. CDC has directly partnered with the VA to implement prevention initiatives resulting in a 60 percent reduction of MRSAin VA facilities over a 32 month period, initially as a pilot project at the local level and ultimately translated into regional and national programs. CDC is working with several groups to assess the effectiveness of several other successful implementation strategies. These and other prevention implementation examples demonstrate the savings in lives and healthcare costs that can result from national implementation of evidence-based HAI prevention programs.

When Infections Occur

The ultimate goal is to ensure that all healthcare is delivered safely across the spectrum of healthcare delivery; however, when an infection control failure is identified, there is a need to notify patients who might have been exposed and to protect other patients from harm. During the past decade, over 120,000 patients had to be notified of the need to seek testing in the context of two dozen incidents and outbreaks involving unsafe injections; additional patients have been notified of risks associated with other errors, such as improper sterilization of equipment. In addition to federal oversight and payment policies to drive prevention of unsafe practices, local and state authorities are necessary to temporarily or permanently halt unsafe medical practices. Once halted, strategies for identifying exposed individuals are needed so that those put at risk by incorrect practices can be notified and provided care.

Patient Notifications

When failures of infection control result in a need to notify patients who were put at risk, such notifications and the accompanying diagnostic testing can be resource- and labor intensive and are not without potential harm to patients notified. Decisions regarding notification of exposed patients when there is no evident disease transmission are challenging. CDC has engaged diverse partners that include state and local health departments, patient advocates, public health professionals, ethicists, healthcare industry representatives, and the Safe Injection Practices Coalition to discuss and obtain input on the ethical and communication issues related to such patient notification. CDC also hosted six focus groups in New York and Atlanta to identify best practices for notification. CDC’s Public Health Ethics Committee also informed the process.

Based on the process described, CDC has developed recommendations for determining whether patient notification should be initiated and how best to do so. This includes evaluation of the problem in order to classify it as Category A: a gross error or demonstrated high-risk practice (e.g., reuse of needles or syringes between patients or use of contaminated syringes to access shared medication vials), or Category B: an error with lower likelihood of blood exposure (e.g., endoscope reprocessing errors). Patient notifications are indicated for Category A. When an error is classified as Category B and there is no known transmission of bloodborne or other pathogens, decisions should be based on several factors, including the risk of infection, the duty to warn versus the potential harm to patients from the notification, and addressing public concerns.

CDC is currently developing a patient notification communications toolkit based on the information gathered through the process above. The toolkit will contain resources for developing documents for patient notification (e.g., sample notification letters, sample patient test results letter, resources for risk communication); establishing communication resources (e.g., setting up a call center); planning media and communication strategies (e.g., sample press release); and best practices for patient notification (e.g. planning the release of media and notification letters, communicating with key stakeholders and partners).

CDC has met with and continues to work with the VA to share CDC’s recommended practices for patient notifications.

Conclusion

Ensuring that appropriate infection control practices are adhered to in all healthcare settings is a priority for CDC. Public health plays an important role in ensuring a unified approach through systematic implementation of prevention practices, monitoring to detect problems, outbreak investigation and control, oversight, education, and research. As healthcare continues to grow in complexity and is increasingly provided in outpatient settings such as ambulatory surgical centers, dialysis centers, and nursing homes, where infection control programs and oversight are generally less rigorous, outbreaks from transmission of pathogens through lapses in basic infection control practices have grown. As a result, CDC has undertaken a number of efforts to evaluate the problem and develop prevention strategies so that these errors do not recur. Many of these efforts are in collaboration with diverse partners, including the VA, allowing for broad implementation of recommended practices.

As we continue to work toward elimination of HAIs, new healthcare settings and changing technology will create new challenges and will require continued vigilance. CDC continues to strive to address those challenges and ensure that patients are safe in every healthcare setting. Infections caused by lapses in basic infection control are unacceptable. We know how to protect patients from these events; they can and must be prevented.

Thank you for the opportunity to testify today; I am happy to take any questions you may have.