Written testimony by Evelyn McKnight, AuD
President/Founder, Hepatitis Outbreaks National Organization for Reform (HONOReform)
415 E 23rd Street, Suite A
Fremont, Nebraska 68025
Phone: (402) 721-8960
Submitted on June 17, 2010 to the US House Committee on
Oversight and Government Reform
2157 Rayburn House Office Building
Washington, DC 20515
"Viral Hepatitis: The Secret Epidemic"
Mr. Chairman and Members of the Subcommittee:
In the last decade, more than 150,000 patients in the United States were notified of potential exposure to hepatitis B virus (HBV), HCV, and HIV due to lapses in basic infection control practices in healthcare settings. The majority of these cases derive from the re-use of syringes, the misuse of single-dose or single-use vials, and the re-entry into a multi-dose medication vial or other infusion containers with a previously used needle and/or syringe. Most recently, a notification was issued to 350 Cerebral palsy patients at Children's Hospital of Pittsburgh. The notification was issued upon learning that a physician had been reusing syringes on multiple patients to administer Botox injections over the course of five years. Earlier this year, 8 patients were confirmed to have contracted HCV while seeking care in a holistic medical clinic in Brandon, FL. This outbreak occurred when an employee failed to follow standard procedures for preparing and administering intravenous therapies.
From coast to coast, no part of this country is immune to such outbreaks. Between 1998 and 2008, there were five reported outbreaks in outpatient facilities across the state of New York that resulted in 70 confirmed cases of HBV and HCV transmission. The 2010 report "US Outbreak Investigations Highlight the Need for Safe Injection Practices and Basic Infection Control" in the Clinics in Liver Disease citied the increased prevalence of such outbreaks occurring the outpatient settings which have less oversight than inpatient hospitals.
There are measures that can be taken to combat this growing public health problem. The authors of the 2009 report "Nonhospital Health Care–Associated Hepatitis B and C Virus Transmission: United States, 1998–2008", as published in the Annals of Internal Medicine, noted that "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." I believe this comprehensive approach can be implemented across all healthcare settings to ensure that no other family goes through the pain and confusion that my family felt after my diagnosis of HCV.
My malpractice litigation took almost four years. When it ended, my husband, Tom (a local family physician), and I made the decision to use my settlement award to establish a nonprofit patient advocacy organization – Hepatitis Outbreaks National Organization for Reform, or HONOReform. Our efforts are focused on advocating for comprehensive injection safety reforms at the state and national levels. HONOReform seeks to eliminate healthcare transmission of hepatitis C and other bloodborne pathogens. This should NEVER occur. We are working to improve oversight and adherence to best practices, educate healthcare professionals about evidence-based guidelines they can use to create a safer environment for their patients, and inform the public about the serious threats posed by improper injection safety practices, especially in ambulatory care settings.
When I first learned of my diagnosis, I was mad, scared, and in search of answers. I confronted a number of challenges along the way including living with chronic HCV – which for me is analogous to having the flu each day of my life. I endured hurtful and untrue stigmas associated with my condition.
When I share the story about what has happened to me and thousand of other Americans, most people react by asking me, "Isn't this Nursing 101?" Don't all physicians and nurses know not to do this? The answer, as we now know, is that "No, basic safe injection practices are not understood and applied across healthcare practices." This must and will change. With the migration of care from the hospital to the nonhospital setting coupled with the rise in baby boomers with hepatitis seeking healthcare for preventive services, I am afraid these outbreaks will continue to occur. HONOReform established a three-pronged policy platform to address specific areas of improving patient safety.
Safety by Incentives – In order to ensure health care providers follow the necessary precautions and protocols to ensure the patient's safety is put first in any health care setting, there must be appropriate mechanisms and incentives in place to guide health care workers.
Safety by Design – Improve the safety of our current system by implementing system change to ensure mistake proofing changes are made in the physical design of healthcare processes and by reducing human error.
Safety by Culture and Empowerment – Through education, outreach, and grassroots initiatives,
influence the culture of patient safety.
Over the few years, HONOReform has been collaborating closely with many different entities around the issue of healthcare transmission of hepatitis C, hepatitis B, and HIV. Together with the Centers for Disease Control and Prevention (CDC), we have formed the Safe Injection Practices Coalition. This coalition of stakeholders, including healthcare providers, industry partners, and patient advocates, created the One & Only Campaign focused on providing education and awareness to patients and healthcare providers about safe injection practices.
Sadly, the root causes underlying these outbreaks of hepatitis B, hepatitis C, HIV, and other blood-borne diseases appear to be a lack of adherence to basic safe practices (you never re-use a syringe), combined with a sobering, misguided attempt to save time and pennies at the margin at the risk of patients' lives.
In June 2007, the CDC and the Healthcare Infection Control Practices Advisory Committee (HICPAC) updated and released their Guidelines for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings. The guidelines take into account the fact that over the last 25 years healthcare services have migrated from hospitals to outpatient ambulatory care facilities. The CDC Guidelines are quite clear when it comes to injection safety. However, these straightforward guidelines are routinely not adhered to in outpatient facilities and private physicians' offices. Simply stated, the Guidelines affirm the following:
1) Use aseptic techniques to avoid contamination of sterile injection equipment;
2) Use single-dose vials for parenteral medications whenever possible;
3) Recognize that needles, cannulae and syringes are sterile, single-use items and should not be reused for another patient nor to access a medication or solutions that might be used for a subsequent patient; and
4) Do not use bags or bottles of Intravenous solution as a common source of supply for multiple patients.
I close with the hope that no more patients will receive a letter like the more than 150,000 Americans, and the one letter I received informing me that I have contacted hepatitis due to the simple act of seeking healthcare from a licensed oncologist for my breast cancer treatment. Healthcare should not be a high-risk behavior. When considering a comprehensive approach to address the hepatitis epidemic, I urge the Committee to address the issue of healthcare transmission of hepatitis as a major contributor to the rise in incident of hepatitis across the country.
Thank you for the opportunity to submit written comments. I look forward to working with all of you in the weeks, months, and years ahead as we move to save lives and ensure patient safety by preventing the spread of hepatitis in healthcare settings.