Serial No. 106-112


Printed for the use of the Committee on Education

and the Workforce

Table of Contents *
















Thursday, June 22, 2000

House of Representatives,

Subcommittee on Workforce Protections,

Committee on Education and the Workforce,

Washington, D.C.

The Subcommittee met, pursuant to call, at 10:35 a.m., in Room 2175, Rayburn House Office Building, Honorable Cass Ballenger Chairman of the Subcommittee presiding:

Present: Representatives Ballenger, Goodling, Barrett, Hoekstra, Graham, Boehner, Isakson, Owens, Miller, Woolsey, Sanchez, and Kucinich.

Also present: Representatives Roukema, Andrews, McCarthy, and Wu.

Staff present: Victoria Lipnic, Professional Staff Member; Robert Borden, Professional Staff Member; Molly M. Salmi, Professional Staff Member; Heather Oellermann, Staff Assistant; Becky Campoverde, Communications Director; Rob Green, Workforce Policy Coordinator; Peter Gunas, Workforce Policy Counsel; Patrick Lyden, Professional Staff Member; Deborah Samantar, Office Manager; Jo-Marie St. Martin, General Counsel; Kevin Talley, Staff Director; Michele Varnhagen, Minority Labor Counsel/Coordinator; Peter Rutledge, Minority Senior Legislative Associate/Labor; Maria Cuprill, Minority Legislative Associate/Labor; and Brian Compagnone, Minority Staff Assistant/Investigations.

Chairman Ballenger. A quorum being present, the Subcommittee on Workforce Protections will come to order. The Subcommittee is meeting today to hear testimony on OSHA's Compliance directive on bloodborne pathogens and the prevention of needlestick injuries.

Under Rule 12(b) of the Committee rules, any oral opening statements at the hearings are limited to the chairman and the ranking minority member. This will allow us to hear from our witnesses sooner and help members to keep their schedules. Therefore, if other members have statements, they will be included in the hearing record. Without objection, all member's statements and other material referenced during the hearing will be inserted in the hearing record.



We are here today to discuss OSHA's recently revised compliance directive on bloodborne pathogens, specifically as it relates to a workplace hazard that has gained increasing attention over the past decade, the prevention of needlestick injuries for health care workers. This is the first time our committee has met to examine this issue.

Let me start by thanking the many health care professionals, from nurses to doctors to researchers, who have worked so diligently to bring this issue to light, and I know many are in the room today.

I would also like to take a moment to welcome our witnesses. We appreciate their willingness to take time out of their busy schedules to testify before the Subcommittee. I note that we had many requests to testify at this hearing. Unfortunately, due to time constraints, we were unable to expand the panel.

I thank the manufacturers for providing us with a product display to help educate us, and I thank others for their written testimony, including the Centers for Disease Control, whose testimony I have read. But among our witnesses, I want to thank Karen Daley, who graciously accepted the invitation of Ranking Member Mr. Owens and myself to be here today.

We are here to learn and gain a better understanding of all the important public health problems confronting our health care workers. Over 10 million workers are employed in health care industries, in occupations ranging from doctors to nurses to dental assistants. Nearly 80 percent of the health care work force is female.

I would also like to add that many members have heard from hospitals in their districts over the past year or so about the nursing shortage in our country and the need to recruit and retain more nurses. I dare say, however, that many people, if they are anything like me, prefer not to see a doctor or nurse.



But even for those of us who are not inclined to spend much time in health care settings, we do know there is one problem for the profession that we can't avoid seeing. We know that health care workers are at great risk for occupational exposure to all types of bloodborne pathogens.

Research over the last decade has demonstrated that accidental needlesticks in health care settings not only happen, but when they happen, the consequences can be severe. We know that there are many means used in the workplace to prevent such injuries, and that the development and use of many safe medical devices is one of those means. We expect to hear about all of those today.

We are also aware that many states have been active on this issue. Since 1998, many states have either passed or considered legislation dealing with the use of safe medical devices. But our role today is a federal one.

The most recent federal action addressing this issue has been OSHA's compliance directive on bloodborne pathogens, which was revised in November of last year. We have certainly had our debates over the past few years in this Committee about other OSHA policies, and about the many forms of OSHA's regulations, from letters of interpretation to compliance directives to the content of the regulations themselves.

So today we will look at OSHA's requirement for dealing with bloodborne pathogens in the workplace, and the requirements for employers to make use of new engineering controls, namely safe medical devices. We will also review what employers must do to comply with the actual OSHA standard. We are interested in how the revised compliance directive has been received and how it is being enforced.

I look forward to a thorough and informative discussion today, and I greatly appreciate the cooperation and effort extended by the Ranking Member, Mr. Owens, and indeed by all the members of this Subcommittee in bringing this hearing together today. I appreciate the time that many members on both sides of the aisle have given to this important issue, and I hope that we will in fact learn from our witnesses and educate the public and ourselves about this important public health issue.

And now, Major Owens, it is your turn.








Mr. Owens. Thank you, Mr. Chairman. Let me first begin by taking this opportunity to thank you for calling this hearing on OSHA's compliance directive on bloodborne pathogens and the prevention of needlestick injuries. The subject matter of this hearing is as important as any that the Congress can consider.

It literally involves the life and death of workers such as Carrie Albu. Carrie Albu is an emergency medical technician for the City of New York. She is 35 years old and the mother of two children. Carrie was part of an emergency services team which responded to a call to attend to an individual who had been stabbed multiple times.

During the race to the hospital, the team worked to save the life of the victim. One of the paramedics used a needle on the patient and then placed it on the mattress. Carrie was working alongside this paramedic, and during the efforts to save the patient she was jabbed by the needle.

Today, in addition to being a mother and an EMT, Carrie is also infected with the Hepatitis C virus, a virus that results in chronic infection for 75 to 85 percent of patients, typically leads to acute liver disease, and can result in cirrhosis and liver cancer. As is the case with HIV, no vaccine exists to prevent Hepatitis C infection, nor is there an effective post-exposure immunoglobulin or antiviral therapy yet.

I would like to relate one additional story relevant to this hearing. Dr. Steven Biermann was an emergency room physician for many years. As a result of an accidental needlestick, he was infected with the Hepatitis B virus. That experience led him to develop catheter securement devices designed to replace tape and suture, and to protect doctors and nurses from potentially deadly needlestick injuries.

In 1991, OSHA published its bloodborne pathogens standard. Though controversial at the time, that standard has unquestionably helped to reduce the spread of bloodborne pathogens among health care workers. Since 1991, however, there has been considerable progress in the development of safer medical equipment, particularly as it relates to needles. However, needlesticks continue to account for up to 80 percent of the occupational exposures to blood.

The question we face in this hearing is whether we are doing enough to ensure the use of safe medical equipment. Many states have acted recently to mandate the use of safer medical equipment. Congressmen Pete Stark and George Miller, and Congresswoman Marge Roukema, have joined to introduce H.R. 1899, a bill that establishes a similar federal mandate, and that bill has 185 cosponsors.

OSHA has also acknowledged the need and is taking steps to improve the protection it affords. It has recently revised and publicized its compliance directive for the bloodborne pathogens standard, to ensure that employers are aware of and utilizing the new technologies that are available. It is in the process of revising its reporting requirements to ensure better accounting of needlesticks when they occur. Finally, it is considering reopening the standard.

I want to commend OSHA for its recent revision of the compliance directive. However, the question remains, can we do more? As I stated at the outset, this is a very serious issue. Errors of omission are potentially deadly.


A sound strategy to combat the spread of bloodborne pathogens must ensure that available safe technologies are used. It must ensure that the workers who use those technologies are involved in their selection and are appropriately trained in their use. It must account for all needlesticks. And it must be applied universally to all workers who are at risk, including public employees who are outside of the scope of the Occupational Safety and Health Act.

Again, I want to commend OSHA for the steps it has taken to improve enforcement of the bloodborne pathogens standard. However, there may be an opportunity for the Congress to do even more. I pledge my willingness to work with Chairman Ballenger towards that end.

Finally, I want to thank Lorraine Thiebaud and Karen Daley and all of today's witnesses for taking the time to be here, and I want to note that we have two of our colleagues who are not members of the Subcommittee, who also joined us today. They are members of the Full Committee, Carolyn McCarthy and Mr. Andrews. We welcome them to remain for the hearing.

Mr. Chairman, I also would like to submit for the record, and ask unanimous consent to include in the record a statement of Representative Pete Stark on this issue of protecting health care workers from needlestick injuries, and a statement by a member of the committee, Representative Dennis Kucinich.




Chairman Ballenger. I would also like to say that Mrs. Roukema is with us, and she is not a member of this Subcommittee but she is a member of the Full Committee.

Now I would like to introduce our panel of witnesses.

Mr. Owens. Mr. Chairman, I asked for unanimous consent.

Chairman Ballenger. Oh, yes, sir. Without objection, so ordered.








Chairman Ballenger. First of all we have the Honorable Charles N. Jeffress, the Occupational Safety and Health Administrator of the U.S. Department of Labor. Second, we have Dr. Murray Cohen, Frontline Healthcare Workers Safety Foundation, Ltd; Ms. Karen Daley, testifying on behalf of the American Nurses Association; Ms. Enid Eck, Kaiser Permanente; Ms. Lorraine Thiebaud, testifying on behalf of the Service Employees International Union; and Dr. Tammy Lundstrom, Detroit Medical Center and Wayne State University, testifying on behalf of the American Hospital Association.

And, sadly, as I thought, we have a 15-minute vote, what do you say we just go right now, and that way we won't interrupt anybody's testimony. So we will see you all in about 6 or 7 minutes. I think that is what it takes to get over there and get back.


Chairman Ballenger. We will get started again. For those of you who didn’t know, and I didn't know, that Mrs. McCarthy was a nurse. So on the trip over to vote and the trip back I got a complete education. I am speaking from intelligent thought now.

But let me remind the witnesses that under our Committee rules, they must limit their oral statements to 5 minutes, but their entire written statements will appear in the record. We will also allow the entire panel to testify before questioning the witnesses.

With that said, Mr. Jeffress, you may begin your testimony.



Mr. Jeffress. Thank you, Mr. Chairman. Thank you and Members of the Subcommittee for inviting me to testify about OSHA's compliance directive on bloodborne pathogens.

OSHA published the final standard on bloodborne pathogens in 1991, in response to the significant risk associated with occupational exposure to blood and other potentially infected materials. The diseases caused by bloodborne pathogens, as you have said, Mr. Chairman and Mr. Owens, include Hepatitis B, Hepatitis C, HIV/AIDS. There are others as well. These are three of the most prominent.

At the time the standard was issued, OSHA predicted that each year the standard is complied with would prevent more than 5,000 occupational Hepatitis B virus infections and more than 100 Hepatitis B deaths. I am happy to report to you that the standard has been an enormous success. Since the standard was promulgated in 1991, the rate of occupationally acquired Hepatitis B infection has declined dramatically. In 1987 there were 8,700 cases of Hepatitis B infection among health care workers. In 1995, 4 years after the standard was published, only 800 new cases related to occupational exposure were reported by the CDC.



Despite the standard's success in addressing the Hepatitis B virus, OSHA continues to be concerned about injuries from needles and other sharps that are contaminated with blood or other infected materials. Needlesticks alone account for up to 80 percent of the occupational exposures to blood, and the health research community

estimates 600,000 to 800,000 needlestick injuries occur annually. Because these injuries continue to be the primary source of occupational exposure to bloodborne pathogens, OSHA and other public health agencies are continuing to stress the importance of reducing these risks.

The bloodborne pathogens standard contains provisions which were designed and written to be performance oriented. In other words, the goals of the standard are clearly stated, yet many aspects of the rule give employers considerable flexibility in choosing the methods most feasible for accomplishing those goals. In this way, of course, it is similar to our ergonomics proposal. If you like our bloodborne pathogens standard, you will love our ergonomics proposal, Mr. Chairman.

The standard directs employers to use engineering controls and work practices to eliminate or minimize employee exposure to bloodborne pathogens, but it does not list or specify particular engineering controls that employers must use. This approach allows the rule to take into account the continual progress of medical research and technology, and the diversity of workplaces and workplace operations and processes, and allows the employer to determine which engineering controls will provide the best protection.

A central provision of the bloodborne pathogens standard clearly demonstrates its flexible, performance-oriented nature. Paragraph (c), Part 1910.1030, requires employers to develop a written exposure control plan that addresses, among other things, the site-specific engineering, work practice, and administrative controls the employer will use to prevent exposure to bloodborne pathogens for workers who have an ongoing risk. In other words, the employer creates a plan that is tailored to the conditions of that particular employer's workplace.

In 1998, OSHA developed a request for information to gather information and data from the public about which strategies were being successfully implemented that reduced the transmission of bloodborne pathogens, and about ideas and recommendations on ways to better protect workers from contaminated needles and other sharps. We received 396 responses to that request, including responses from nursing homes and clinics, acute care and rehabilitation facilities, pediatric hospitals, individual health care workers, researchers, unions, educational institutions, professional associations, and manufacturers. There was a wide range of comments.

We learned three critical things from those comments: one, that a variety of safer devices were already being used and effective in a number of workplaces to protect workers from needlesticks and sharp injuries; however, we also learned the devices were not being used widely enough to reduce the overall risk substantially. We learned that training and education in the use of safer medical devices and safer work practices were effective and were being proven effective to prevent exposures in these workplaces. And we learned that employee involvement in the selection process plays an important role in the acceptance and the proper use of medical devices.

In November 1999 we issued our compliance directive. Compliance directives generally guide OSHA compliance officers by providing instruction in how to apply the standard and ensuring that consistent inspection procedures are followed. I want to emphasize that the current directive is a restatement, a clarification, if you will, further explanation of the requirements of the bloodborne pathogens standard. It does not amend the standard. It does not create new legal duties or obligations or defenses.

But while the standard has not changed, control technologies and medical treatments have. In the years since the standard was promulgated, the ability to control exposure to bloodborne pathogens has improved significantly. These developments provided the impetus for OSHA to update our compliance directive.

There are five main areas where additional instruction has been incorporated into our compliance directive. These areas are, and I will mention each of them briefly, an emphasis on the annual review of the exposure control plan; a clarification of how employers must evaluate and implement engineering controls; a description of necessary employee training; new medical recommendations from the CDC; and an explanation of how the standard should be applied in multi-employer workplaces.

Chairman Ballenger. Charles, can you find a break in there somewhere?

Mr. Jeffress. There are these five points to the directive. Let me give you just a word on the exposure control plan, and then I will summarize. That is the most important.

The exposure control plan must identify those tasks and procedures where occupational exposure may occur, and the individual workers who need to receive training, protective equipment, vaccinations, or other protections from the standard. In light of the increased use and acknowledged feasibility of safer medical devices, the plan must document the employer's consideration and implementation of appropriate, commercially available and effective engineering controls. The annual employer review and update of the plan ensures that it reflects changes in technology, such as the use of effective engineering controls, safer medical devices, that can eliminate or minimize employee exposures in the workplace.

This provision, along with the training and engineering control provisions of the plan, Mr. Chairman, the employer assistance that we are providing through OSHA's compliance assistance, through our internet capacity, through our 10 regional bloodborne pathogen coordinators, we believe will make a significant difference in continuing to reduce the workplace exposure to bloodborne pathogens.




Chairman Ballenger. Thank you, Charles.

Dr. Cohen, you may begin your testimony.



Dr. Cohen. Mr. Chairman, honorable members of the committee, I am Murray Cohen, chairman of the Frontline Healthcare Workers Safety Foundation. Previously I served as a Public Health Service scientist for 21 years with the Centers for Disease Control, and I have worked in the area of health care worker safety and needlestick injury prevention since 1981. I sincerely appreciate this opportunity to speak with you today about the underlying epidemiologic basis for the OSHA compliance directive and occupational transmission of bloodborne pathogens.

Please let me open by thanking and congratulating the Subcommittee for your leadership on this important public health issue. Health care worker safety is not a partisan issue. Bloodborne viruses are deadly, equal opportunity pathogens. Safety in hospitals for both workers and patients is good public health, good medicine, and good business.

The emergence of important new bloodborne pathogens over the last 20 years has made needlestick injury prevention a public health priority. I have submitted for the record a more comprehensive history of how our public health and scientific communities rose to these challenges.

Let me just say that on May 27, 1987, the CDC published the first reports of occupational transmission of HIV infection to three health care workers. Health care worker safety and patient safety at once became immediate public health crisis issues. The OSHA bloodborne pathogens standard crafted in this environment required the best practices for prevention of bloodborne pathogen transmission that were known at that time.

Unfortunately, health care workers are still suffering injuries that can transmit bloodborne infections. Although we often refer to these generically as ``needlestick'' injuries, these include all types of sharp object injuries. Causes include broken glassware, hollow-bore needles, solid needles, scalpels, surgical wires, etcetera. Good data suggest that 600,000 of these injuries still occur in the U.S. in hospitals each year.

The care and treatment of workers following high risk needlestick injuries is difficult and costly. These workers endure 6 months of counseling, blood tests at prescribed intervals, safe sex precautions, and the fear that they may become infected during this period of latency or incubation. The employer or insurance company must pay the costs of clinical management, which can include worker compensation, laboratory tests, treatment with anti-HIV drugs and their side effects, and psychological counseling and treatment.

Furthermore, since 1992 we have come to recognize that the Hepatitis C virus may be the bloodborne pathogen of greatest significance for risk of occupational transmission to health care workers. This virus is responsible for 40 percent of all chronic liver disease in the United States. It is the single highest underlying cause of



liver transplants in the United States. HCV exposures can cost worker compensation plans as much as $600,000, and more if a liver transplant is required. And the overall assessment of the risk for occupational transmission for HCV is that it is 40 times greater than that for HIV.

The OSHA bloodborne pathogens standard is a regulation that is effectively preventing injury and disease in the workplace. As Mr. Jeffress just testified, incident new Hepatitis B infections among health care workers declined 95 percent between 1983 and 1995. This remarkable success in disease prevention was due in large part to the requirement by OSHA in 1991 that all health care workers at risk for blood and body fluid exposures be vaccinated against Hepatitis B.

Dozens of scientific studies have demonstrated efficacy of injury surveillance and implementation of safety devices, but there are no absolutes. This problem is a difficult one to solve. Successful injury reduction requires that every facility gather its own

unique surveillance data, target its highest risk areas with multiple intervention strategies, and conduct evaluation trials of safe medical devices that meet the demands of its individual, complex work environment.

Perhaps the most important conclusions from studies of occupational transmission of bloodborne pathogens over the past 20 years are, first, there are really no minor occupational bloodborne pathogen exposures. Even in the absence of transmission of infection, exposures may subject workers to time-consuming, stressful and painful medical follow-up, while employers or insurance companies must pay expensive medical and indemnity claims.

Second, the vast majority of these exposures are preventable with techniques and technologies that are available today.

Third, these are enormously complex problems. Solutions require that every facility conduct surveillance to identify their specific problems. Maximum safety can only be accomplished through comprehensive, multifaceted strategies that include the use of engineered sharps safety devices by interdisciplinary teams of workers and management, working together in each health care institution.

And, finally, the value of needlestick prevention is going up, as the cost of medical management of the injuries that occur will necessarily go up as new drugs are developed for new and existing bloodborne infections.

Thank you.




Chairman Ballenger. Thank you, Dr. Cohen.

Ms. Daley, you may begin your testimony.




Ms. Daley. Thank you, Mr. Chairman. Good morning, Mr. Chairman and Members of this distinguished Subcommittee. I am Karen Daley, a registered nurse and president of the Massachusetts Nurses Association. I appear today on behalf of the American Nurses Association and its 53 constituent state and territorial nurses associations.

ANA appreciates this opportunity to speak to you on an issue of great importance to the 2.6 million registered nurses and other health care workers in the United States who face the risk of potentially lethal needlesticks every day. Health care workers sustain an estimated 600,000 needlestick injuries per year. At least 1,000 of those workers contract serious, potentially life-threatening infections like HIV and Hepatitis C.

Despite the fact that safer devices have been available since the 1970s, and that we know more than 80 percent of these injuries can be prevented through their use, fewer than 15 percent of U.S. hospitals have switched over to these devices, except in states that have enacted laws requiring them. As a result, thousands of health care workers each day are stuck by needles and needlessly exposed to disease. And for some truly unfortunate health care workers, one needlestick can become a devastating source of infection and illness that has a lifelong, life-altering and life-threatening impact.

I am one of those individuals. In July of 1998, while working in a hospital emergency department where I had been a nurse for more than 20 years, I sustained a needlestick. After a routine occupational health follow-up 5 months later, just before New Year's of 1999, I received the horrifying news that I was HIV and Hepatitis C positive. It is impossible for me to describe for you how that one moment, the moment when I reached my gloved hand into a needle box to dispose of the needle with which I had drawn blood, has drastically changed my life.

My primary care has been taken over by a physician who specializes in infectious diseases, and primarily HIV management. I am also followed by a hepatologist who manages the Hepatitis C. I have had weekly to monthly blood tests drawn, easily totaling hundreds of tubes over the past 18 months. In the first year of my treatment, I took a daily regimen of potent antiviral drugs, a regimen that at one point consisted of 21 pills a day and an injection, and caused a wide range of debilitating side effects.

Mr. Chairman, this injury didn't occur because I wasn't observing the necessary precautions, or because I was careless or distracted or not paying attention to what I was doing. Worst of all, this injury didn't have to happen and would not have happened if a safer needle disposal system had been in place in my own work setting.

We have made some progress. In November 1999, OSHA released a compliance directive to the bloodborne pathogens standard. This directive provides instructions to OSHA inspectors to cite employers for failing to evaluate, purchase and implement safer

devices and needles. While ANA commends OSHA for releasing this directive, we

strongly believe this process should be taken one step further and that, for a number of reasons, these requirements need to be placed into the actual standard through federal legislation.

First, the legislation is needed for public sector employees who are not covered by OSHA. These and all health care workers must be protected. At its current funding level, OSHA has the ability to make one spontaneous visit per facility about every 75 years. We also know that OSHA will increase the number of inspections in response to complaints. In the absence of complaints, however, workers are assuming unnecessary and potentially life-threatening risks in settings where safer devices are not being used, despite the directive and the widespread availability of these safer devices for more than 20 years.

We know the risk for health care workers and the cost to this Nation will only grow over time. As thousands of preventable needlestick injuries continue to occur around this every day, the cost of not requiring the use of safer devices also grows. The

average cost of followup for a high-risk exposure is almost $3,000 per needlestick injury even when no infection occurs. Based on estimates of 600,000 needlesticks a year, the cost for followup alone is $1.8 billion. According to the American Hospital Association, one case of serious infection can soon add up to $1 million or more in expenditures.

The federal legislation is needed for a number of reasons, not the least of which is the fact that the compliance directives are easily subject to change and amending, and that amending the bloodborne pathogens standard itself through regulation is too slow a process, given the unacceptable risks to which hundreds of nurses and other health care workers are exposed to every day. ANA urges Congress to amend the standard by statute so that nurses and other health care workers could be assured expeditious protection.

In offering our strong support for federal legislation, I think it is also important to be clear on what we are and what we are not saying. We are not suggesting an unreasonable or cost-prohibitive approach to what we believe is a preventable and serious public health issue. We are not suggesting that employers use the most expensive devices on the market. We are saying that employers should choose and utilize devices that are found most effective in their own environment. We are saying that the financial resources should be used to prevent injuries and exposures, not simply to follow up workers once they have needlessly been exposed.

Everything possible must be done to protect health care workers from preventable exposure to injury and disease. The legislation is critical to that end. I share my personal story with you today, and I will continue to do so, so that no other nurse, doctor or health care worker has to experience what I am going through. And, as always, ANA remains committed to continuing to work with you and other members of this committee and Congress to ensure safer needle devices become the norm for every health care worker in America.

Thank you for allowing me the opportunity to offer testimony on this important public health and workplace issue.



Chairman Ballenger. Thank you, Ms. Daley, and let me just say that we appreciate your willingness to speak publicly about your experience. It is obvious that what you have been through is very personally and physically devastating, and you have our deepest thanks for participating in today's hearing.

Ms. Daley. Thank you, Mr. Chairman.

Chairman Ballenger. Thank you.

Ms. Eck, you may begin.



Ms. Eck. Good morning, Chairman Ballenger and distinguished members of this Subcommittee. Thank you very much for inviting me to share with you some of our experience in California as we have implemented the recent sharps injury prevention legislation and the Cal-OSHA bloodborne pathogens standard. As the representative from Kaiser Permanente, I will also share with you some important lessons that we have learned, and that I trust will be helpful as you consider the task before you.

Kaiser Permanente is the nation's largest integrated medical care program, providing health care to over 9 million individuals across this country. In California alone, we provide care to more than 6 million members, and have 30 hospitals and 130 medical offices. We employ over 50,000 employees and have 8,000 physicians.

Because of our extensive history of promoting patient and health care worker safety, Kaiser Permanente has established a leadership role in sharps injury prevention. Through the coordination of the organization's Sharps Safety Committee, which I have chaired since 1991, we have been implementing sharps safety devices. And, depending upon the specific device, we have experienced injury reductions; we have experienced no reduction in the targeted injury class; and unfortunately we have experienced some increases in injuries with selected safety devices.

This experience has provided some very important lessons, and verified that there is no simple solution, just as Dr. Cohen said, for this very complicated problem. We support sharps safety legislation, but believe that such legislation should explicitly incorporate specific requirements that address the essential elements of patient safety; the use of a sharps injury log and the data in that log to evaluate and act on product efficacy; reasonable flexibility that permits clinicians to utilize appropriate clinical judgment; and legislation that helps to promote technology development.

Current safety technology does not exist for all of the devices that cause sharps injuries. Despite the number that is on that board, there are literally thousands of devices that can cause injuries to health care workers, and in many cases the alternatives that you see here do not come and are not available in all of the sizes, gauges and lengths that we need. Without specific legislative language that assures the importance of patient safety, health care workers are put in the untenable position of trying to use currently available technology in ways that may reduce patient safety or impair basic health care delivery.

Because the OSHA 200 log contains personal identifying information, including the employee's full name and/or identification number, which in some cases may be their social security number, workers concerned about privacy protection may avoid reporting sharps injuries because of concerns that medical record confidentiality may be breached. The Cal-OSHA sharps injury log provides a better database for sharps injury reduction efforts by including information not currently contained in the OSHA 200 log, and excluding information that is perceived as a barrier to reporting injury. Relying on the OSHA 200 log rather than the sharps injury log would ultimately reduce our ability to prevent injuries, because the information could be incomplete due to employee underreporting and lack of useful data.

In addition to the limitations built in and inherent in our current safety technology and the engineering features of many devices, there are patient-specific issues or procedures that may preclude the use of selected safety devices. These situations are limited, but our most vulnerable patients may be put at increased risk if clinicians are not permitted to utilize their expert clinical judgment in selecting the most appropriate sharps needle device.

Legislative language that specifies limited design types may hamper the free market, competitive development of innovative technology. The more generic description in the Cal-OSHA standard, which is defined as needles or sharps with built-in, engineered safety protection, is more likely to facilitate innovative design and manufacturing, and encourage the kind of breakthrough technology that will ultimately help to solve this problem.

In conclusion, preventing sharps and needle-related injuries is essential, but it is a very complicated challenge with no simple solution. The inclusion of exceptions in legislation that assure patient safety, comprehensive injury surveillance, encourage appropriate clinical judgment, and provide incentives to technology improvement, will effectively protect the public and our very valued health care work force.




Chairman Ballenger. Thank you, Ms. Eck.

Ms. Thiebaud, you may begin.



Ms. Thiebaud. Good morning, Chairman Ballenger and members of the Workforce Protections Subcommittee. My name is Lorraine Thiebaud, and I am a registered nurse at San Francisco General Hospital, where I have worked for over 25 years. I am chapter president for Local 790 of Service Employees International Union.

I very much want to thank the Subcommittee for holding this hearing, and for the opportunity to testify before you about the need to protect our nation's health care

workers from needless needlestick injuries. I am speaking today on behalf of Service Employees International Union, the Nation's largest and fastest growing organization representing health care workers.

You have already heard from Karen Daley. And, Karen, your story has been especially moving to me because it reminds me of many other stories. I want to begin with Peggy Ferro. On February 7, 1992, and using the pseudonym of ``Jean Roe'', Peggy Ferro testified before a congressional committee about how she contracted HIV from a conventional needle. She testified on the need for immediate action to prevent others from contracting this deadly disease.

But here we are, eight years later, and 85 percent of the needles in use in this country are still conventional needles that can kill. Peggy Ferro died on November 4, 1998 from her needlestick injury. If Peggy Ferro had had retractable technology like this, she would be alive today.

Needlesticks are not a small problem; they are an epidemic. Safer technology exists to protect us from needlestick injuries. We must not let any more health care workers needlessly suffer the same tragedy as Peggy.

My coworker, Janet Christensen, testified alongside Peggy in that 1992 congressional hearing. She told the committee how she had accidentally jammed a needle contaminated with both HIV and hepatitis into the palm of a medical student next to her in a crowded preoperative room. She was first worried, and then she was very angry when she discovered that the hospital had purchased safer needle devices but rationed them because they were too expensive.

That is when we decided that we needed to make the campaign for safer needles at our hospital a priority. It took us a year and a lot of work, but our hospital finally agreed to use safer needles.

Six years later, one of my coworkers, while moonlighting at a substance abuse clinic, Ellen Dayton is her name, was stuck with a contaminated needle. She contracted HIV and Hepatitis C. She started immediately on the AZT, but her Hepatitis C infection prevented her from using the medications. She almost died in the first months. She survived with a 60 percent hearing loss and a very poor prognosis. Ellen would be here today in my place, but she is too weak and ill to be here.

After Ellen was stuck, we decided that we had to move on a State level so that all of our coworkers would be protected regardless of where we worked. We worked with local politicians and the SEIU Nurses Alliance in order to bring about groundbreaking legislation in California to protect health care workers by banning unsafe conventional needles except under very limited circumstances, and we won. That was in 1998.

SEIU, along with thousands of health care workers, has helped to build a movement across this country that has resulted in a number of States passing needlestick prevention laws. But there is no question that if Peggy and Ellen were here today, I know


what they would say. A law in California or Texas is good, but it is not enough. We must have a national standard for everyone: for workers, for health systems, and for manufacturers.

A stronger national standard will not only save lives but will save unnecessary cost to the health care system. The cost for safer devices may be more expensive in the short run, but we know from our work in California that in the end it costs more to treat ill and injured needlestick victims.

Today we applaud OSHA for the revised compliance directive. It is a much-needed guide for inspectors that has already resulted in citations for violating the existing bloodborne pathogens standard, but it is not enough. Bill 1899, the Health Care Worker Needlestick Prevention Act, with 185 cosponsors, contains critical elements that are needed to provide stronger protection for health care workers.

Employers must use safety devices. They must allow health care workers to provide information and to participate in the evaluation and selection of safer devices in their institutions. There needs to be a sharps injury log that will require employers to give us all the information necessary to prevent future needlestick injuries. We need to require that current bloodborne pathogen standards be implemented within one year. We have waited too long. And we need to extend these protections to all health care workers in both the public and the private sector.

It has been over 3 years since Ellen lost her health, and it has been 2 years since my friend Peggy died. This epidemic can be solved, but not simply through science. It must be solved through political will. Today behind me there are doctors and nurses and other health care workers who have their own stories about the toll that needlestick injuries have taken in their lives. Today I am here for my friends, Peggy, Mary, Paula, and for Cindy, who can't be here. We need to do something now to protect millions of health care workers around this country from needless needlestick injuries.

Thank you.




Chairman Ballenger. Thank you, Ms. Thiebaud.

Dr. Lundstrom, please begin.



Dr. Lundstrom. Mr. Chairman, I am Dr. Tammy Lundstrom. I am the medical director for epidemiology at the Detroit Medical Center, and also an assistant professor of medicine in the Division of Infectious Diseases at Wayne State University's Medical School in Detroit. The DMC operates seven hospitals, two nursing centers, and more than 100 outpatient facilities, and cared for approximately 1.9 million patients last year.

I am here today representing the American Hospital Association and its 5,000 hospitals and health systems, in support of OSHA's bloodborne pathogens standard. As director of epidemiology for the Detroit Medical Center, I manage the clinical aspects of our sharps injury prevention program. I am responsible for investigating and analyzing sharps injuries that occur within our hospital system. I personally provide on the spot and followup counseling to any injured health care worker in our system. We also conduct a thorough analysis of how, when and why the injury took place, and recommend procedural and safety device changes to prevent a recurrence.

In addition to my work at the Detroit Medical Center, I am a practicing HIV/AIDs physician in Detroit's inner city. I see and care almost exclusively for HIV-infected and AIDS patients in my clinical practice, and I understand firsthand how critical bloodborne pathogen standards and sharps injury prevention programs are for patients, and especially for health care workers.

Mr. Chairman, AHA and its members have a profound commitment to ensuring the safety of patients and health care workers. In 1989, the AHA provided hospitals and health systems with our guide ``Sharps Injury Prevention: A Step-by-Step Guide.'' We will continue to advocate sharps safety and injury prevention.

We are especially proud of our collaboration with OSHA when the agency developed the 1991 bloodborne pathogens standard and its compliance directive. The standard revolutionized safety for approximately 5.6 million health care workers at risk of exposure to bloodborne pathogens such as HIV.

Based on this key standard, hospitals and health systems across the country developed and implemented sharps injury prevention programs. Many adopted needleless systems and engineered devices, where appropriate, for their patients and their health care workers. All are deeply committed to patient and health care worker safety.

In 1998, OSHA reviewed its compliance directive and requested information from hospitals across the Nation about their sharps injury prevention programs. AHA members, alerted by a special AHA membership advisory, provided detailed information about their programs and use of engineered devices.

The results prompted OSHA to update its compliance directive for the bloodborne pathogens standard. Consistent with the wider array of devices available in the marketplace, the directive now explicitly includes safety needles and other engineering devices in its definition of engineering controls, and also requires their use. The AHA issued a membership advisory outlining OSHA's changes.

Mr. Chairman, we believe OSHA's 1999 directive provides enforcement guidelines that are comprehensive, clear-cut and decisive, but flexible enough to allow evaluation of new and existing devices. Many devices that are less traumatic to patients,



more accurate and safer for workers, are in use today, while others are being developed and tested. We believe this flexibility is essential. The engineered devices that are effective for patients and employees in one hospital may not be effective for those in another.

At the Detroit Medical Center we have had a sharps injury prevention program in place since 1989. Our program covers all seven facilities. Each facility has a slightly different plan and may evaluate different devices, depending upon the patient and employee population and the procedures performed.

More than half of our Sharps Injury Prevention Committee is made up of frontline health care workers, including myself, who chairs the committee. This committee selects devices for testing based on our needs and the recommendations from the National Institute for Occupational Safety and Health at the CDC. Then we conduct limited clinical testing within each of our hospitals.

During the limited trials we monitor the use of the device and collect detailed evaluations from those health care workers testing it: Is the device easy to use? Is it intuitive? What training will be required to use it correctly? Is it effective for patients? Is it effective for health care worker safety?

Based on answers to these questions, the committee selects the appropriate devices to implement throughout the facility and conducts intensive training sessions for employees on the correct use, disposal and handling of the device. After the device is in use in the clinical setting, we continue to monitor its effectiveness and provide additional education and training sessions.

In addition to our device-specific education sessions, our health care workers participate in mandated annual competencies. This is a comprehensive overview of our entire sharps injury prevention and bloodborne pathogens education program. This evaluation and training takes place every time we change a task, procedure or device within our hospital system. It ensures safety for our patients and safety for our health care workers.

Let me conclude this morning by saying that the Detroit Medical Center and its practices are just one example of what hospitals across the country are doing to ensure the safety or their patients and health care workers. The current OSHA standard and its revised 1999 compliance directive mandate the critical elements which must be included in sharps injury prevention programs, while leaving the specifics to the health care professionals.

Thank you.




Chairman Ballenger. Thank you, Dr. Lundstrom.

I would like to remind members that Committee Rule No. 2 imposes a 5-minute limit on our questions, and I think I will be a little stricter on ourselves than I was on our witnesses. It is unfair to bring you this far and not give you the chance to testify thoroughly.

Mr. Jeffress, let me just say I think I like this one better than I did ergo, just to let you know. Mr. Jeffress, I want to make sure that I understand something clearly for the record, up front, and in so doing I want to direct your attention to the exact language in your compliance directive which we have highlighted on the board here in the room.

Now, you talk a lot in your compliance directive about the use of safe medical devices, and you go on to say, ``where engineering controls will reduce employee exposure either by removing, eliminating or isolating the hazard, they must be used,'' and that is in quotations. Now, as I read that language, it is a clear mandate from OSHA that hospitals must evaluate and use safe medical devices. Is that true?

Mr. Jeffress. Yes, sir, that is an accurate reading of our language.

Chairman Ballenger. But let me ask you a question. Did you pick that up? I just wondered if, say, what they have done in Detroit. You questioned a whole bunch of hospitals on what they were doing and so forth, when you put this together, did you not?

Mr. Jeffress. Yes. We got nearly 400 responses from people about what practices they had with respect to safer devices. It was clear from those responses that there are safer devices on the market and they do make a difference. So in our writing of the directive, we made it clear that employers had to use those safer devices where they found them to be safer.

As Ms. Eck pointed out, it is not every case where a safer device is currently available, but in nearly every case we believe, based on the information we received, that there are safer devices available, and so this directive instructs employers to use them.

Chairman Ballenger. Now, let me just get this straight for the record. So for any hospital or other institution out there that may be thinking that they do not have to currently be looking at and using safety devices, they are kidding themselves?

Mr. Jeffress. Certainly from OSHA's point of view they are. I would have to footnote that, Mr. Chairman, by acknowledging what has been pointed out by members of this panel, that the OSHA directive only applies to private employers and to public employers in those states with state plans, so more than half the states in this country, public employees and public hospitals are not covered by our directive.

Chairman Ballenger. Well, if an OSHA inspector showed up at the hospital, what is it that he would have to be looking for, according to your directive?

Mr. Jeffress. Our compliance officer will look for the exposure control plan, which we believe to be the most important part of the program that the hospital or nursing home would have in place, and that plan would specify where their exposures are, what types of devices are found to be effective. We would review that plan and interview employees to see whether devices are in fact being used.

Chairman Ballenger. Now, as both you and I know, North Carolina is an OSHA state, an OSHA state plan state.

Mr. Jeffress. Yes.

Chairman Ballenger. I wonder if you might take a minute to explain the effect of the compliance directive, in particular use of safety devices, for a state like yours and mine.

Mr. Jeffress. For those states with state OSHA programs, they are required to adopt standards as effective as ours. Every state has adopted the bloodborne pathogens

standard. The directive, the instructions we give to our compliance officer, is not mandatory for states. Most states do adopt those same instructions and pass them along to their employees. Some states, such as California, that might have different rules which they view to be more effective, will have different instructions.

But in North Carolina the directive has been adopted. The state there is using these same requirements. Compliance officers in North Carolina, when they go into public or private hospitals, are asking these same questions, assuring that safer devices are being used.

Chairman Ballenger. Well, why in public hospitals in non-state plan states is it that--

Mr. Jeffress. The OSHA Act does not apply to public employees, so Federal OSHA has no jurisdiction over public employees except for federal employees. We do cover federal employees. State and local employees are not covered. However, should a state choose to operate its own state plan, we insist that that state plan cover public employees in those states.

Chairman Ballenger. There is kind of a gap there, it seems like.

Mr. Jeffress. There is a bit of a gap, yes.

Chairman Ballenger. I would like to address a question to Ms. Eck or Dr. Lundstrom. Can you explain to me what is involved in evaluating any one device and putting it in use in a hospital? You have got an acre of devices over there, and I know there are a bunch more than that. Ms. Eck, you go first.

Ms. Eck. Certainly. We have a similar committee to what Dr. Lundstrom described, and it includes frontline workers. We identify a series of potential devices, get feedback on whether those devices may be used and would be effective, and then actually evaluate those for a period of time in various health care settings to determine clinical acceptability, and do they work with all of the other kinds of equipment that employees have to use.

Based on those evaluations, which are objective, there is a form that employees have to fill out, devices are selected, and then employees are trained on how to use them, and those are implemented. And to the degree to which we can eliminate conventional products, we do.

One of the problems, as I mentioned in my testimony, is that even with the safety devices that we have now, which are substantially better than a few years ago, they don't come in all of the sizes and lengths that we would need. So, for example, with a premature infant that would fit in the palm of your hand, you need particularly small devices to be able to use on babies like that. And most of the manufacturers, because the market is such, they will go for the highest use.

Chairman Ballenger. Let me just ask Dr. Lundstrom, if you can give me a short answer, somewhat similar to what she is doing.

Dr. Lundstrom. Yes, we have an evaluation committee, and first we look at every device available in the category. Then, through the committee, with frontline health care workers, we try to narrow it down. Some of the devices that purport to be safer require you to pull the safety device towards you or pull the needle towards you, or there are a variety of different criteria to evaluate devices.

We try to choose three or four of the things that we think in the committee are going to be most safe, and then trial them in our institutions with an evaluation form; bring that back to the committee, decide on a product; do education for 20,000 health care workers which are in a constant turnover, constant flux of medical students, medical residents, physicians, nurses, etcetera; bring the device in. And then it is not just a matter of bringing the device in, it is a matter of trying to remove all the old devices, which is not always possible.

Chairman Ballenger. I don't want to cut you off, but if I am not being fair to everybody else by letting myself run too long, I will be in trouble.

Major, it is your turn.

Mr. Owens. For further clarification that Mr. Jeffress was asked, the bloodborne pathogens standard was completed in '91, and that required engineering and work practice controls to prevent exposures. But I see that Secretary Herman issued a letter last year which supports the goals of H.R. 1899, which are consistent with the Department goals regarding this same issue.

Do you agree that we still need to amend the bloodborne pathogens standard, and do we need a law to make this happen? I think you were asked that, but I just want to make it clear. I didn't get your answer quite clear. A law means for all, to cover all states.

Mr. Jeffress. The letter from Secretary Herman indicated support for the intent of the bill for several reasons. One is the coverage of public employees obviously is something that OSHA cannot do by itself, so to cover public employees around the country, congressional action would be necessary.

The bill also has in it a log which not only would specify who is having injuries, where the injuries are occurring, where the problems are, but the log proposed in the law specifies the type of device that is being used. Manufacturers and purchasers might be interested in that kind of information. OSHA does not mandate that kind of information.

We are looking at our bloodborne pathogens standard. We have promised to reopen that and address issues that remain, that we could not address simply through a directive but would have to address through a change in the standard itself. So there are still improvements that are needed here, Mr. Owens.

Mr. Owens. Ms. Thiebaud, do you think that without California's needlestick law, that you would have been able to have safer devices in your hospital? Is there some way workers could have bargained and gotten the same benefit?

Ms. Thiebaud. In 1991 we started our fight for safer needles in my hospital, and through the agreements procedure we were able to get safer needles. That process took over a year. By the mid-90's we saw the interest that our administration had in one of the best AIDS hospitals in the United States wane under the pressure of economics,

In 1997 I saw my coworker, Ellen Dayton, moonlighting at another hospital, a substance abuse clinic where 80 to 90 percent of the patients or client population was known to be HIV or Hepatitis C infected, stuck by a needle. She was working on city property at the time. In that instance a researcher, a doctor, was offered a nonsafety device for free, or he could pay 47 cents for a safety device. He chose to save 47 cents. He didn't consider the impact of that cost on my friend Ellen, on her daughter, on her family.

I do not think that, without federal legislation, that all workers in this country in the health care field will be adequately protected. And I don't think that other workers have the opportunity or we should expect them to have the leisure to go through the process we went through at San Francisco General.

Mr. Owens. So, despite that impressive set of safety devices over there, we still have, I think somebody said 600,000 to 800,000 needlesticks per year, which means that something has to happen to make them make use of all these various devices in greater numbers.

Ms. Thiebaud. We were shocked to discover that only about 15 percent of the devices used in this country are safety devices, even today, over 15 years after the beginning of the AIDS epidemic.

Mr. Owens. You mean some of those devices might be put up as safety devices but they are really not safety devices?

Ms. Thiebaud. Some are better, some are worse. What we need is direct worker participation to give feedback to the industry, to decide what is better, what is worse, and how do we get new stuff in. It will take time, but it is only through utilizing the wisdom of health care workers across the United States that we are going to get the kind of technology we really need to prevent all needlestick injuries.

Mr. Owens. From your experience, do you think the fear of needlestick injuries has affected large numbers of nurses' attitudes, and do you find more nurses are eager to retire or leave for other jobs, or is it more difficult to recruit nurses?

Ms. Thiebaud. We are in a period of very large nursing shortage. I can't speak in general. I can speak very specifically to myself. I have, since 1981, many times questioned my own wisdom in staying in this industry. I love my job.




I have been cornered by my mother, my husband, my brother, my aunts and uncles, all of whom say, ``Why are you doing this?'' Or ``Why at least do you not stop working in a public hospital? Why don't you go to one of those nice hospitals where people don't have these dreaded diseases?''

I don't know where those nice hospitals are. I have moonlighted in a few of what people consider to be nice hospitals, and I try to convince my family that it is scarier to work there, where people are in denial about the fact that people who have HIV and Hepatitis C look exactly like me, and that they would not recognize my friend Mary or my friend Ellen as someone who looked like they could give them a needlestick injury that would threaten their lives.

So I think it is very important for health care workers across this country, and for the recruitment of new nurses, to know that they have a safer industry to work in; that the health care industry currently is not a safe place to work, but it can be made safer through federal legislation.

Mr. Owens. Thank you.

Ms. Thiebaud. Thank you.

Chairman Ballenger. Mr. Boehner?

Mr. Boehner. Well, thank you, Mr. Chairman, and let me begin by congratulating you for having this hearing on this very important subject. I think that the issues that affect our society deserve to be aired in our Nation's Capital, in front of this Congress. And the fact that you were willing to have this hearing and to bring this important issue to light I think is an important step, and I want to congratulate you for that.

This is, as Dr. Cohen said, and I will quote, ``a difficult problem to solve.'' Clearly, in hospitals and other settings where needles and other sharp objects are used, it is difficult to eliminate all hazards.

But from the testimony we have heard, Mr. Jeffress, I think it is clear that the bloodborne pathogens standard requires employers to evaluate and use safety devices, but it also appears to me to be clear that this requirement is not well known of hospitals and of a lot of health care workers, of what OSHA in fact, what the requirements are. What, if anything, is OSHA doing to inform hospitals and health care workers about your requirements?

Mr. Jeffress. Dr. Lundstrom mentioned the American Hospital Association is working in partnership with OSHA to try to get information out to hospitals on the requirements of the bloodborne pathogens standard and the directive. We use trade associations; we work with unions to try to get information to their members about this.

We have it on our web site, an educational piece on our web site about the requirements of the OSHA bloodborne pathogens standard. We actually are working in partnership with the Joint Commission on Accreditation of Health Care Organizations to talk about OSHA requirements generally. This one to some extent we can work into those training sessions, as well.

We have 10 coordinators, one in each region of the country, that are specialists in bloodborne pathogens, that work with people who have questions, that go out and do training and seminars. So we are trying to reach out. You are right, Mr. Boehner, we have not penetrated every hospital yet, we have not penetrated every health care worker yet, but it is a part of our outreach to attempt to do that.

Mr. Boehner. Dr. Cohen, you indicated in your testimony that every health care facility has unique problems that need to be addressed by each facility. Could you explain why a one-size-fits-all solution to the problem of sharps injuries fails? And, if you could, give us your opinion as to whether OSHA's compliance directive gives the health care facilities the necessary flexibility to deal with their unique problems.

Dr. Cohen. Mr. Congressman, the health care industry or any hospital setting is as complex a workplace as we have anywhere in this country. There are so many things happening simultaneously. We know from studies in other industries of techniques that

we call the sequence of events analysis, such as you would use to investigate a train wreck, when injuries occur they usually are not a simple violation of, as Karen Daley testified, being careless or some other simple problem. It is usually convergence of lots of problems happening at the same time. That is why we call them accidents.

Because of that, a one-size-fits-all regresses to the mean. There will be plenty of circumstances where a particular device will not be designed or cannot be used to cover the particular circumstances that will cause a particular injury to occur.

My opinion, and so far the early reports are in, studies that have been presented at scientific meetings recently are that the strategy used, the methodologies used in the OSHA compliance directive do indeed provide the flexibility, as Dr. Lundstrom testified, for health professionals and facility managers to try multiple different devices under multiple different circumstances, using management and workers together to pick devices that will be effective in a specific setting.

Mr. Boehner. Ms. Eck, beyond the testing requirements of these new devices, and I think you suggested that there aren't safety devices to replace all of the sharps in health care facilities, but beyond the testing and the decision about which of these may be appropriate for your settings, what else does a health care facility need to do in order to introduce these new safety devices in the workplace?

Ms. Eck. There is a substantial amount of education that needs to be provided to any employee who is going to be using the device, and there is a need to, after the device has been in for a period of time, to go back and ensure that in fact it is being used appropriately and is effective in reducing injuries.

I mentioned in my testimony the sharps injury log, and it is very important to be very explicit in that log, so that if you know a certain particular device is causing a number of injuries, you put a safety device in, did the injuries actually be reduced as a result of that device? So there is a lot of followup that needs to be done after the device goes in.

Mr. Boehner. Thank you.

Thank you, Mr. Chairman.

Chairman Ballenger. Mr. Miller?

Mr. Miller. Thank you, Mr. Chairman.

Mr. Jeffress, in your testimony you said you found three things as a result of the comment period, and one of them was the need to involve employees in the process. I think, Dr. Cohen, you testified essentially to the same thing in your testimony, saying that

there need to be interdisciplinary teams of workers and management working together in these institutions. Ms. Daley, you testified also on the need for the employees to be involved in this.

I just wondered, since that is a requirement, as I understand it, of the California provision, if, Ms. Thiebaud, you and Ms. Eck would like to tell us how that is working.

Ms. Eck. From our perspective it is working extremely well. We actually had included frontline workers on our sharps committee long before anybody told us we had to. We found that their insight and understanding of the tasks and the convergence of things that can occur was invaluable in helping us choose devices, so it was very helpful.

Mr. Miller. Has that led to modifications, I mean, where--

Ms. Eck. Oh, absolutely, in terms of which devices we would even consider evaluating. It was very helpful.

Mr. Miller. Do you find employees more willing to try out different devices if they are involved in--

Ms. Eck. If they are involved in helping to select, yes, they are generally more willing to try out devices and follow through with it, yes.

Mr. Miller. Ms. Thiebaud?

Ms. Thiebaud. I was on the first needlestick prevention committee in 1991, prior to the passage of the California legislation, and we found that maintaining workers on these worker-management committees was extremely difficult. Due to time constraints, people were unwilling to allow workers to truly participate in these committees, and by 1995, I believe, our committee was unilaterally disbanded by management.

It was only subsequent to the passage of the California legislation that mandated worker participation in these committees that we found a new attitude on the part of management, and we now have a 16-member committee, 8 management, 8 union, which work together. It is co-chaired, and we actually get our release time to participate.

I think it is invaluable in convincing our members that the safety devices that we bring in are the ones that are the best for them. They have a say in what they are. It is very difficult for all of us to adapt to changes in technology, but I think by having workers participate that you get the best compliance. Thank you.




Mr. Miller. Ms. Thiebaud, thank you. Thank both of you. Ms. Thiebaud, what is the situation with respect to extended care facilities, nursing home facilities, and compliance here in usage? Obviously SEIU is involved in a number of those facilities. What do you know about that?

Ms. Thiebaud. I am unfamiliar, although I would be willing to get you the information, with compliance in the state of California in non-acute care settings.

Mr. Miller. Because we have a declining number of AIDS/HIV patients in those facilities but we still have a significant number of patients who may be, in some cases for a short period of time, but the law obviously applies to them.

Ms. Thiebaud. Yes.

Mr. Miller. So I just wondered, in terms of their ability to provide the kind of training necessary, and again they have such a high turnover rate of employees. If you have any information on that, I think it would be important for us to take a look at it in consideration of this.

Thank you very much, and Mr. Jeffress, thank you. I think OSHA should be commended for this compliance directive. Thank you all for your testimony.

Chairman Ballenger. Mr. Barrett?

Mr. Barrett. Thank you, Mr. Chairman, and I too want to thank the panel for the excellent testimony that has been presented here today. I am interested, of course, in the work that specifically you have done in California, and Ms. Eck and Ms. Thiebaud in particular. A lot of states, including my own in Nebraska, have introduced or passed bills in this area, and I think California is certainly among the 20 or more states that have done it already.

I guess in listening to your testimony, and especially because I have three manufacturing entities in my district that produce millions and billions of the needles that we are talking about today, and then in listening to Mr. Jeffress and his testimony a moment ago, the question that was answered about the gap between the federal regs and the state regs or lack thereof, it just occurred to me with the work that you have done in California, and Mr. Jeffress' answer, perhaps a far-out question, but is this in your opinion, this whole issue, a public health issue, or is it a states' rights issue? Ms. Eck?

Ms. Eck. Oh, I was wondering who you were going to ask that question.

Mr. Barrett. Then we will go to Ms. Thiebaud. I think she answered it a moment ago, but go ahead, please.

Ms. Eck. I believe it probably is a public health issue. There is definitely a concern on the part of not only the work force but I think the general public. But again, as with any public health issue, there is not a simple solution. It is complex. There are a lot of pieces, and it takes a lot of people working together to try to address those.



Mr. Barrett. Would any panelist disagree with that answer, that it is a federal?

[Panelists shake heads negatively.]

Ms. Thiebaud. I think that actually, if I can speak to that issue, that making it a health care issue rather than a states' rights issue, you actually make it easier for national manufacturers and national health organizations to implement policies, rather than confronting a broad variety of regulations. It is much easier. And of course my goal ultimately is to see all health care workers provided with safety devices, and I think it makes it easier for all of us to work if it is seen as a federal issue.

Mr. Barrett. Thank you.

Dr. Cohen, as an expert in occupational hazards, I am wondering if you have done

any work in terms of costs versus benefits in this area that we are talking about, of implementing a needlestick prevention program. Are there any numbers, any figures available, in your opinion?

Dr. Cohen. Mr. Congressman, that is actually a very controversial question for a number of reasons. First, very often when the term "cost" is used, it is being misused, and the reference is to price. Price of a product or a safety intervention is merely one component of overall cost.

Cost-benefit is often controversial because not so much of what is the cost or what is the benefit, but who is paying on either the numerator or the denominator side of that question. So the motivations to make a decision may be imbalanced according to the equation, if I may.

That being said, it is very difficult in an individual hospital or facility to have large enough numbers to see a very specific price, cost and benefit, particularly for a disease that may manifest many of its costs years later after the exposure, such as Hepatitis C. On the other hand, there are a number of models, they have been presented, I am not aware of any that have been published yet, I am aware of a lot of research, and we expect publication soon, that are demonstrating nationally, across national scope, that indeed safety in this industry, and specifically with respect to prevention of bloodborne pathogen exposures, will prove to be good business in a fashion that probably can be described as cost and benefit.

Mr. Barrett. Thank you.

Dr. Lundstrom, in your experience in California, when these precautionary measures are taken, do you have any idea whether or not insurance costs are lowered? Does this have any effect on insurance premiums?

Dr. Lundstrom. Not that I don't feel qualified to answer that question, but if I could speak for a minute, I would like to stress the fact that even with safer needle technology, the CDC estimates that about a third of injuries are not preventable with current technology, and that is because we need to have a sharp to penetrate the skin. About a



third of the injuries in the CDC's data base occur during the process of penetrating the skin, before activation of the safety feature would be recommended, so that even adopting all of the technology that is available, we will not with current technology be able to completely eliminate the risk to health care workers.

In addition, the procedure that I perform most frequently other than blood drawing is a spinal tap, which requires a long needle with an inner solid needle inside the hollow needle. I have to insert that in the patient's spinal cord, pull out the inner solid needle, allow the fluid to drip into tubes, reinsert into and then remove the entire device. There is no safety feature available with current technology, so technology is lagging behind in our ability to totally eliminate sharp injuries from the workplace.

Mr. Barrett. After that description, let's leave it right there, shall we? Thank you, doctor. Thank you, Mr. Chairman. My time is up.

Chairman Ballenger. Ms. Woolsey?

Ms. Woolsey. Thank you, Mr. Chairman.

Just a thought. I guess for prevention we better start investing in AIDS research, so that we don't have this in the first place to be worried about, and Hepatitis C.

Mr. Jeffress, your budget, did you say that you had 10 trainers and staff available nationwide to help with the questions and training on these issues? Or what did you say?

Mr. Jeffress. We have one person in each region who is a bloodborne pathogen coordinator, whose primary responsibility is to deal with bloodborne pathogens. Now, we have many more of our 1,000 person inspection staff that are trained to do inspections when they go into hospitals, but there are 10 specialists in this field.

Ms. Woolsey. So in a perfect world, how many would you like to have in order to get the message out? I mean, we are talking about how do we get everybody involved in this.

Mr. Jeffress. Thank you for this opportunity.

Ms. Woolsey. You can always count on me.

Mr. Jeffress. It is true that, as someone said, we do about 2 percent of the nation's workplaces every year. Hospitals have a large number of injuries. As a matter of fact, there are so many injuries in hospitals that we have added them to our special survey that we are doing this year in order to identify which hospitals have the highest injury rates, so we can increase the number of inspections.

But with current resources, we are still limited to about 2 percent of the workplaces. If we could double the number of resources, it would still only be 4 percent. We at least need to do that.

Ms. Woolsey. Well, and we are talking about prevention also.

Mr. Jeffress. Yes.

Ms. Woolsey. To be called in to help be a resource and not just be the police.

In California, with Cal-OSHA, correct me if I am wrong, now, if Cal-OSHA standards are stronger, then the state can stay with their standards. If OSHA standards are tougher, then they have to go with the national standards, right?

Mr. Jeffress. That is correct. States can have more rigorous standards than federal OSHA has. California in a number of areas has tougher standards, and this is one.

Ms. Woolsey. Thank you very much.

Dr. Lundstrom, in your hospital association, do you have hospitals outside of California?

Dr. Lundstrom. No, all of our hospitals are in southeastern Michigan. We have seven hospitals, all of which are in southeastern Michigan. In the American Hospital Association, which I am representing today, there are hospitals throughout the country. In my particular facility, Detroit Medical Center, all of our facilities are in southeastern Michigan.

Ms. Woolsey. Well, that is what I meant, the American Hospital Association that you are representing.

Is there a way to track the difference between California hospitals that have mandatory standards versus the other hospitals in the country, to see the difference that these mandatory standards make? Have you done that, as an association?

Dr. Lundstrom. There are two national databases in the United States that are in use, the EPI Net data from the University of Virginia and also the CDC's NASH data that are used. And all of the hospitals that I know, especially in the Michigan Hospital Association, use that data which is freely available to try to compare themselves to the national standard.

Ms. Woolsey. And is there a difference that you know of between, for instance, California or Texas hospitals that are under--

Dr. Lundstrom. I believe most of the California information, and maybe Ms. Eck can correct me if I am wrong, because it is a relatively new initiative and it takes some time to develop data, that we don't really have any published information yet with which to compare other AHA hospitals with California hospitals.

Ms. Woolsey. I was going to ask Ms. Eck the same thing because I know Kaiser has hospitals other than in California.

Ms. Eck. To my knowledge, there has not really been a thorough analysis of that. The sharps injury log that was mandated by the Cal-OSHA standard actually began, the first part of it, in January of '99, and then was fully implemented July 1st of 1999, so we don't even really have a full year of data across the State. Within our organization we have a standardized database, but that certainly is not as broad-based as AHS.

Ms. Woolsey. And do you apply the high California standards to your Arizona facilities, so that everybody is--don't you have facilities in Arizona?

Ms. Eck. Not in Arizona, we don't, no. But in all of the areas where Kaiser does exist, yes, the same standards have been applied.

Ms. Woolsey. Thank you very much.

Chairman Ballenger. Mr. Isakson?

Mr. Isakson. Thank you, Mr. Chairman.

Mr. Jeffress, I believe in your testimony you stated since the first publication in 1991 there has been a significant decline, particularly in hepatitis and other transmissions from needlestick. Is that correct?

Mr. Jeffress. Yes, in Hepatitis B. Dr. Cohen indicated, the vaccinations required for Hepatitis B are a significant reason for that decline.

Mr. Isakson. And your regulation only applies to private, not public, hospital facilities. Is that correct?

Mr. Jeffress. Except in those states with state plans, where they apply.

Mr. Isakson. I understand.

Mr. Jeffress. But in Georgia, Ohio, Nebraska, others, it does not apply to public hospitals.

Mr. Isakson. Out of curiosity, has there been any research done, and maybe Dr. Cohen may know the answer to this, on the difference between the number of instances of needlestick problems in public versus private institutions?

Mr. Jeffress. I am not aware of any research on that.

Mr. Isakson. Dr. Cohen, are you aware?

Dr. Cohen. Yes, and I can refer to the EPI Net data set that Dr. Lundstrom mentioned, that is collected and published out of the University of Virginia. They have found that the average rates of sharp object injuries in teaching hospitals are higher than the average rates in non-teaching hospitals. Many of the teaching hospitals are in fact community or public hospitals, so they would not be covered.

It is generally believed that the explanation for the different rate, the higher risk, if you will, in the teaching hospitals, first, you have patients who are sicker, so they may be in a facility longer and have more procedures accomplished. And also you have got a lot of klutzy medical trainees there.




Mr. Isakson. Thank you. I would like to repeat what the Chairman said for Ms. Daley. We want to thank you very much for being here today. It is only when people like yourself are willing to come forward, obviously in a difficult circumstance, to help us to do better work, and we want to thank you for being here.

And I wanted to ask you a question, because I think you are the most appropriate person to answer this question. OSHA has stated that some of the difficulty has been on the part of some medical and health care professionals' reluctance to change practices in terms of what they use or don't use. And being a skilled nurse and a health care professional, and one who is as close to this issue as anybody, have you seen evidence of occupational resistance on the part of those who use needles to change and use safer types of devices?

Ms. Daley. Thank you. I think that is a very important question to ask, and I think it is a natural expectation actually in terms of what we are going to accomplish as a nation hopefully, as we convert these systems over, that people will resist. I think there are a couple of reasons for that resistance.

One is just a level of discomfort with a new technology that they are not accustomed to, but I think also it has to do with adequate training. I think many of the panelists have spoken in terms of the importance of selection, and involvement of the frontline health care worker in that process of selection and evaluation. And we know, based on research to date, that clearly that involvement is key in terms of reducing that resistance. It is the first tool we have to reduce that resistance to converting these systems over.

So it is a natural, I think as a toddler is awkward when it learns to walk, I think there is no difference in terms of a system that has used these unsafe devices for as long as it has been in place. But I think as these technologies become available and as they are used on a greater basis, we will see more innovation and a greater development of a comfort level, I think, in terms of the technologies themselves.

Mr. Isakson. Thank you. One last question. Ms. Eck, I think you are a part of the review process in California, where there are exceptions to the law, where the physician or the nurse can actually make a decision in terms of which type of device to use. Everybody up here I think testified, particularly the medical professionals, at one time or another as to the complexity of the hospital environment.

And just sitting up here thinking about the difference between an EMT in an ambulance going 60 miles an hour giving an injection, versus someone drawing a serum from one vial to another that never in fact is used invasively on the human body, to the operational environment, to an HIV patient, tell me just briefly, because I think my time is running out, I take it, being familiar with that, that flexibility is absolutely essential in being able to do the right thing both for the patient as well as for the health care provider. Is that a correct statement?

Ms. Eck. Absolutely. I think if we can trust the clinicians to make wise choices in terms of patient care, we should be able to trust them to choose what needs to be done with the patient. It is rare that they would need to choose to use something that was not a safety device, but there are times when it needs to be done that way.

Mr. Isakson. And I take it, based on that vivid description of a spinal tap, that is one of those exceptions?

Dr. Lundstrom. Yes.

Mr. Isakson. Thank you.

Thank you, Mr. Chairman.

Ms. Eck. We could probably give you some others.

Chairman Ballenger. Thanks a lot.

Mrs. McCarthy?

Mrs. McCarthy. Thank you, Mr. Chairman, and I thank you for having this hearing. I have to tell you, sitting here, I just thought of my whole nursing career, and I don't think there is anyone at the table, or maybe, you look really good, then, when I started nursing, one of the first things we learned in nursing school was taking the needle and actually taking a nail file and burring it down. That is how far we have come. We also used glass encasements which broke all the time. So we have come and innovation has come. And as a nurse who has gone through many, many different changes in care, as far as the different needles and everything else, I understand where we are today.

But one of the things that I think is most interesting is, when you have 85 percent of our hospitals not using the correct needles, immediately I say, well, obviously if we do this on the federal level, innovation will have to come with it, because then the demand will be there. We know the competition will be there.

And I probably was the only one sitting at this hearing that did not get upset when you were talking about a spinal, only because I have assisted in many of them, and I understand the complications of that. But also, which was brought up here, I also know all the different circumstances. I worked in ICU for many, many years, and came through the emergency room and worked there. We know as nurses what we have to deal with with different patients. Someone that might seem extremely calm, at any moment could have a sudden jerk, certainly be uncooperative, and unfortunately that is when we end up getting stuck with needles.

I was lucky. I got stuck with a lot of needles in my day, but going back into the '60s, I didn't have to worry about many of the diseases that we are facing today. In the '90s, I did, and it was scary, because now all of a sudden you were faced with, ``I could die,'' and I have faced that because I did start taking care of AIDS patients, and it really changes your whole attitude, and you want to make sure that you are doing the right thing.

I think through this committee hopefully we will have federal legislation, with the understanding, of course, with the flexibility that needs to be done with the hospitals. You know, our hospitals are not getting enough reimbursement as it is, to take care of the patients that they need to take care of and to the health care workers. So I am hoping that this Committee will be able to do something, with all of your input, certainly.

But do you agree with me, as we go with innovation and have the technology that will come to the future, because we will force them to go into that technology so that we can cover all the different situations that are in the hospital? Dr. Lundstrom?

Dr. Lundstrom. Thank you. I will restrain myself from describing any further medical procedures. But I believe that OSHA's compliance directive is very comprehensive, and the fact that both the AHA document, which is very comprehensive and helps hospitals to set up their safety program, and OSHA's compliance directive, which mandates an annual review of the bloodborne pathogens standard to update your standard and your devices according to developing technology, is really critical. And I think that the mandate is already there with OSHA's compliance directive.

I also don't want to get to involved in disputing over numbers. I personally believe, and Premier Safety Institute has numbers to suggest that up to 80 percent of hospitals are implementing some types of safety procedures, safety devices, I think that getting into a numbers game distracts us from what our common goal is, which is to improve health care and patient safety. But I believe that the numbers of hospitals using safety devices are higher than that, and I believe that the OSHA compliance directive will increase that further.

Mrs. McCarthy. My concern--go ahead, Dr. Cohen.

Mr. Cohen. Congresswoman, if I might, the record has already clearly demonstrated, just as you suggested, over the last 10 years since the OSHA bloodborne pathogens regulation was promulgated, it drove the development of the technologies that we are seeing now. I believe it was Ms. Eck who testified that some of the earlier devices were much less effective or a lot more clumsy than the second and third and fourth generation devices we see now, so clearly that regulation drove technology.

It is not just in safety devices. What we are also seeing now is a virtual explosion, at least if you look at the number of patents being filed in the areas of safety broadly defined, new diagnostic procedures that use so much less blood or body fluid that the need for as many blood draws in fact is reduced; medical procedures that are in fact being developed, that are minimally invasive or noninvasive, so that it reduces the number of times that you have a clinical circumstance where a needlestick injury could even occur.

So I think it is important to consider the very profound and positive effect on development of technology that any such federal action takes, based on what we have seen from the federal action that was taken in 1991.

Mrs. McCarthy. Thank you. I will just say one thing, to Lorraine and Karen and to the nurses out there. I need help here, so if you would like to run for Congress, we would really appreciate it. You are doing a great job. Thank you.

Thank you, Mr. Chairman.

Chairman Ballenger. Thank you.

Congressman Graham?

Mr. Graham. Thank you, Mr. Chairman. I am not a nurse, I am a lawyer, so I do know about sticking people every now and then.

In terms of needles, no one hates them more than I do, so if we can make them safe, and if you can do what Dr. McCoy does on Star Trek, I am all for that, too, so nobody has to be stuck.

But getting back to the legal aspects of this, I think everybody is on board with the idea we need to make the practice of medicine as safe as possible for nurses and everybody else who takes care of us, and count me in that crowd. But I am trying to find out, the best I can, the difference between the regulation and the bill legally, and make sure that we make some good policy decisions here that, you know, if necessary force the industry to comply, without overly regulating things to the point it gets to be absurd.

Let's just sort of compare the regulation and the bill. One difference, it seems that the OSHA regulations leave out a lot of people. Is that correct, Mr. Jeffress?

Mr. Jeffress. OSHA regulations only apply in the private sector, and in the public sector in certain states. South Carolina is covered, but 21 states have no coverage for public employees.

Mr. Graham. Would the bill fix that? Would the bill apply to every one?

Mr. Jeffress. Of course you could amend the OSHA statute to apply to folks. The bill as proposed, that Mr. Stark and Mrs. Roukema proposed, would apply to all hospitals, so that bill would also cover public employees for this particular health and safety issue. It would not cover them for other health and safety issues.

Mr. Graham. Okay, but that is one thing the bill would do that the regulation doesn't do. Is that correct?

Mr. Jeffress. That is correct.

Mr. Graham. Now, as I go down the bill, I am trying to find out, it basically says the same thing as the regulation, that people shall use needleless systems and control sharp instruments the best they can, and it has an exception that basically is the flexibility exception in the regulation. But the statute also has an exception that says if you can show us where it doesn't make sense, you are compromising the safety of the patient, then we will give you a pass. That is basically what the regulation says also, isn't it?

Mr. Jeffress. That is correct. Yes, sir.

Mr. Graham. Okay, so in that regard they are the same.

The exposure control plan, the sharps injury log, does OSHA have a counterpart to that? Is there a tracking system in this country that details these type of injuries?

Mr. Jeffress. The log that the bloodborne pathogens standard requires tracks the injuries. The OSHA 200 log only tracks the needlesticks or other sharps injuries that seroconvert, where someone has to have medical treatment because of the injury. The

sharps log that is proposed here in the bill would not only talk about tracking people who have the needlesticks, it would also track which devices are being used when the injury occurs.

Mr. Graham. Would that be helpful?

Mr. Jeffress. I think it would be helpful to purchasers to know what kinds of devices are causing problems, to manufacturers to know what kinds of devices they need to modify.

Mr. Graham. Okay, so that would be of benefit, you think?

Mr. Jeffress. Yes, I believe it would.

Mr. Graham. Over the existing regulation, in the bill. Okay. Now, back to the cost of the technology and the implementation of the legislation. Could anyone tell me the difference in cost between the regulation that mandates safety devices and the bill that mandates safety devices? Is there a cost estimate out there, what one would cost over the other?

Mr. Jeffress. We have not done such an estimate in the Labor Department.

Ms. Thiebaud. I have only one comment, which is that in the year following the passage of the legislation in California, Cal-OSHA did an estimate that said that over $100 million would be saved in California alone on a yearly basis through the implementation of the legislation, and that includes the costs of testing, of treating, and of workmen's compensation. That does not even include treating people who have HIV or need liver transplants subsequently. But I believe the cost advantages are very great in terms of its benefit from the legislation.

Mr. Graham. Now, is the cost saving because of the bill or the regulation? I mean, what is the difference between the cost savings of the legislation and the regulation? Do we know?

[No response.]

Mr. Graham. I guess the point I am trying to make is that when you look at the regulation and you look at the bill, there are very small differences. But one of the differences is the people it would apply to, and there seems to be a more detailed tracking system in the bill. But it all comes back to OSHA. The bill mandates you to do this.

Mr. Jeffress. Yes.

Mr. Graham. So we are having the same problem as with the regulation, and I just want to make sure that we make a good decision here and not create a hybrid piece of legislation that mucks things up, because the trends are right. The trends are going well. I mean, due to a lot of reasons, due to Ms. Daley and other things, we are having the trends break our way in terms of safety. I don't want to do anything legislatively that is going to break these trends the other way because of some hidden cost that we don't know about. But if you could get me any information on that, I would appreciate it, and I am very open-minded about what to do here, so--

Chairman Ballenger. I don't want to cut everybody off completely, but we are going to have a vote coming up and there are two people more that would like to have a say.

Mr. Graham. Thank you, Mr. Chairman.

Chairman Ballenger. Mr. Andrews?

Mr. Andrews. Thank you, Mr. Chairman. I first want to thank you and Mr. Owens for your graciousness in permitting us to participate in this hearing. I am a proud cosponsor of the legislation introduced by my friend from New Jersey, Mrs. Roukema, and by Mr. Stark, and I appreciate it.

Ms. Daley, I just wanted to say to you I am sorry I didn't hear your testimony personally. I was detained at something else. But I am sorry for what happened to you, and I know that doesn't mean very much, but for you to be able to come here and talk about this today is uncommonly courageous and shows great integrity, and I really do appreciate it.

And I wanted to ask you some questions about this cost issue that we are batting about. You have been under significant medical care now, I assume, for seven months?

Ms. Daley. Actually about 18 months.

Mr. Andrews. About 18 months. I'm sorry. How many different medications are you on right now, if you care to tell us?

Ms. Daley. I have been on three separate, different regimens for the HIV because I have developed complications intermittently with the HIV regimens, so I have had to change my medicine. What I described in the testimony was probably the worst point in my life, when I was up to 21 pills a day and an injection.

Mr. Andrews. Do you have any idea how much that has cost?

Ms. Daley. I did. I actually added up the cost of my drugs for the first year, and it was over $30,000.

Mr. Andrews. And you see a specialist on a regular basis?

Ms. Daley. I do.

Mr. Andrews. Obviously she is not in an HMO. She gets to see a specialist.

Ms. Daley. Actually, for the first seven months I was seeing my primary care, who is now an infectious disease attending.

Mr. Andrews. And do you have any idea what the fees for those followup visits have been?

Ms. Daley. Actually, some of it has been absorbed by workmen's comp, some of it has been picked up. Some of it I have paid privately, actually.

Mr. Andrews. Do you have a guess as to what the sum total of it is?

Ms. Daley. No, I don't have that. I can get that information.

Mr. Andrews. There have been other treatment regimes and so forth. Could you give us just a ball park guess of how much has been spent on your care in the last 18 months?

Ms. Daley. I don't think it would be unreasonable to say, in terms of blood work, meds, and the physicians' visits, over $100,0000.

Mr. Andrews. Now, we had earlier testimony that the cost of one of these devices in California is 47 cents a needle. Is that right? I'm sorry, Ms. Thiebaud?

Ms. Thiebaud. My name is Lorraine Thiebaud. Yes, that is correct.

Mr. Andrews. Does anyone here dispute that that is an accurate estimate of the cost of one of these safe products? Does anybody think it is more than that? You can buy a lot of needles, 47-cent needles, for $100,000. I mean, I think that Ms. Daley's story is really dramatic evidence, unfortunately, of the point that Ms. Thiebaud is making about the $100 million in savings. Here is a situation where an expenditure of 47 cents for a needle would have avoided $100,000 in costs, not to mention the unbelievable personal anxiety and suffering that she and her family have suffered.

I am all for flexibility. I think that the work that Ms. McCarthy talks about, that is done in a pediatric ward, is very different than the work in the emergency room. She knows about that and I listen to her.

But I also understand this. In this country, improvements don't get made unless they are required. We can be as voluntary as we want, as cooperative as we want. We would still have leaded gasoline if we didn't pass a law 30 years ago that said you have to have unleaded gasoline. And I just believe that we need a clear, definitive statutory standard that says that every employer, public and private, needs to do the very best they can do as soon as they can do it.

And I must say this to you, too, and some of my friends on the other side I think betray an unusual lack of faith in the dynamics of the marketplace. I believe that if we made this a strong and clear mandate, there would be such an incentive for the pharmaceutical companies and the other medical equipment manufacturers to rush in and sell in this marketplace, I think that cost would come down. I think it wouldn't be 47 cents a needle anymore. It would be a lot less than that. And I think that the smart worker's comp carriers and health carriers would insist that research be done and that purchases be done, because they are the ones who are paying a large piece of the $100,000 that Ms. Daley just talked about.

So I am fully sympathetic with the idea of flexibility, but we shouldn't let that be an excuse not to act. And I think Mr. Ballenger deserves credit for assembling us today to have this hearing. I would urge him, with all due respect, to take the next step and let us take a vote on this bill, and move it along and do the things that ought to be done.

I thank the panel, and yield back the balance of my time.

Chairman Ballenger. At long last, Mrs. Roukema.

Mrs. Roukema. Thank you. Technically, I am not a member of this Subcommittee, but I am a member of the full committee. However, I am a cosponsor of that famous or infamous bill that has been referenced here, 1899, and I want you to know that my mantra has always been ``health and safety first,'' and I think this particular subject that we are discussing right now is a good example of why it should be.

And to put it another way, not only ``health and safety first'' for my mantra, but I think for all of us here on this panel, we should understand that what we are discussing today is not the question of inflexibility or mandates or anything else. We are talking about good medicine and good business for everybody.

And so I appreciate what I have heard on this panel. One of our friends indicated that she thought, the nurse, Enid Eck, I believe, and someone else said that there are no simple solutions but that we do need a modification of the statute. Maybe Ms. Eck didn't say that but others did say it, and I think we do need a modification of the statute, without making inflexibility.

By the way, if 1899 were implemented, there wouldn't be that gap with public employees or public hospitals. It covers everybody that is on Medicare or Medicaid. But

I am concerned about how we close the gaps here. For example, one simple thing I would like you to amplify, one simple thing would be adding a compliance date to what OSHA is doing in terms of the compliance directive.

It seems to me that that is so obvious, and I don't think I heard anyone mention that as one of the statutory changes. In fact, maybe it could be a regulatory change. I don't know, but it seems to me that would be an elementary statutory change that we should make, and not get mixed up in this whole question of who has the most advanced new technologies. Those new technologies will take care of themselves, I believe, as we go through, both cost factors as well as implementation.

But I would like to hear what our OSHA director has to say on that, and then down the line with other statutory requirements that should be addressed here.

Mr. Jeffress. The OSHA bloodborne pathogens standard, of course, is already in effect, and people are already to be in compliance. Although many are not yet in compliance, it is required. But the advantage--

Mrs. Roukema. Excuse me. You are not implying that there is a directive as to a final date. It is open-ended, is it not? Unless the state, like California and the other states, have acted upon it. I am talking about a federal standard. Do I misunderstand?

Mr. Jeffress. Well, the standard we adopted in 1991 is in effect. Should we adopt a new regulation, there would be an extended period of time. One of the advantages of your bill, Mrs. Roukema, is that by Congress making a finding that this is a hazard and that there are feasible solutions, you would greatly expedite OSHA rulemaking, which at times is known to go on at great length.

Mrs. Roukema. So, in other words, you are saying that we do need the statute that would get us to that rulemaking standard that would be demanded of OSHA; that right now you have the discretion but you can't implement it?

Mr. Jeffress. Yes, ma'am. The statute would greatly expedite that. If the bill required that the rule be produced by a certain time, we would produce it by a certain time.

Mrs. Roukema. Thank you. Other comments on that aspect? Do you agree or disagree, or don't know? No, in principle, aren't you in agreement that there has to be an implementation of the program and not wait for it state-by-state?

Ms. Daley. I think that is why we are all here.

Mrs. Roukema. Dr. Cohen is not shaking his head yes or no.

Dr. Cohen. I am a public health person with a foundation that has 501(c)(3) status.

Mrs. Roukema. Oh, I see.

Dr. Cohen. I am not sure I want to comment on a specific piece of legislation.

Mrs. Roukema. All right. Doctor?

Dr. Lundstrom. I believe that OSHA's compliance directive is an enhancement of the 1991 standard, so the engineering controls mandate is already in effect and has been in effect since--

Mrs. Roukema. No, it is not really in effect until there is a date certain for compliance.

Mr. Jeffress. It is in effect for the standard that was adopted in 1991, but for the enhancements that this bill proposes, an action by Congress to give us a date to adopt it would enhance our ability to do it.

Mrs. Roukema. All right. Yes, other comments?

Ms. Thiebaud. I wholeheartedly agree. I fought in California, along with Enid, for a 1-year time line for the legislation. I mean, our slogan, our pins, have always said, ``No more Peggys, no more Ms. Daleys, no more Jane Doe 1's.'' It needs to happen now. We can't wait any longer.

Ms. Daley. And I have to say--

Mrs. Roukema. Yes, I wanted to hear from you, Ms. Eck.

Ms. Daley. If I could just add--

Mrs. Roukema. Yes, please.

Ms. Daley. --the Hepatitis C virus, which Dr. Cohen talked about, is expected to triple in terms of its prevalence in the next 20 years. We currently are estimated to have about 4 million cases of Hepatitis C in this country. Many of them are currently undiagnosed, so they are non-identified individuals, and if we talk about 12 million in a short 20-year time



span, and with Hepatitis C as the leading cause of liver transplant and significant morbidity associated with it, as well as mortality, I think that presents an additional urgency to acting in terms of moving this issue beyond waiting for a standard to go through the normal steps to be--

Mrs. Roukema. I thank you, and I apologize. I addressed you by the wrong name. Nurse Daley.

Ms. Daley. Yes.

Mrs. Roukema. Yes. Thank you very much.

Any other final comments?

Ms. Eck. I would just say that we in principle would support the legislation, but within the concerns that I identified in my testimony as far as the flexibility and patient safety.

Mrs. Roukema. I don't think the flexibility is a problem. It seems to me--

Chairman Ballenger. Marge?

Mrs. Roukema. Yes. Go ahead.

Chairman Ballenger. I just got a note that we have a vote.

Mrs. Roukema. Well, I would just invite any further comments that you might have as to how the enforcement--I don't think the flexibility is a problem. I think the question is whether or not we can get reasonable enforcement of the standards nationwide. And any further comments you have, if you would submit them in writing, we would appreciate it. Thank you.

Chairman Ballenger. Very good.

Mr. Owens. Mr. Chairman?

Chairman Ballenger. Yes, sir.

Mr. Owens. Mr. Chairman, I ask unanimous consent that a statement of the American Federation of State, County and Municipal Employees be inserted in the record, along with an item entitled ``Victim Stories.''

Chairman Ballenger. Without objection.

I want to thank you all for being witnesses and for your valuable testimony, and the members for their questions. We approached this hearing hoping to be educated on a very important issue, and I am sure we did get a great deal of education, in spite of some of it that scared me. You have all given us a great deal to think about today.

If there is no further business, the Subcommittee is adjourned.






[Whereupon, at 12:38 p.m., the Subcommittee was adjourned.]