Statement of Matthew Miller, M.D., Vice President, Medical Affairs,
Danbury Hospital, Danbury, Connecticut,
on behalf of the American Hospital Association

Testimony Before the Subcommittee on Health
of the House Committee on Ways and Means

Hearing on Health Quality and Medical Errors

March 7, 2002

Madame Chairman, I am Matthew Miller, M.D., Vice President for Medical Affairs at Danbury Hospital in Danbury, Connecticut.  I am here today on behalf of the American Hospital Association’s (AHA) nearly 5,000 hospital, health system, network, and other health care provider members.  We are pleased to have the opportunity to testify today on an issue of critical importance for hospitals and the patients and communities they serve: improving health quality by developing strategies to ensure patient safety and reduce medical errors.

Danbury Hospital is the primary diagnostic and treatment center for approximately 361,000 residents in western Connecticut and adjacent counties in New York State.  We are a major teaching facility with a highly skilled staff and state-of-the-art technological capabilities, which include: a Level II trauma center; magnetic resonance imaging (MRI); laser, laparoscopic, and endovascular surgery; two linear accelerators; interventional radiology; a neonatal Level II nursery; and a state-of-the-art cancer center.  The hospital is recognized as a regional referral center and as the community health center for Danbury and the surrounding areas.

I have spent most of my 30-year career in health care as a practicing pulmonologist and physician executive.  As Vice President for Medical Affairs I have administrative responsibility for clinical quality and safety, utilization of clinical resources, risk management, medical staff credentialing, regulatory compliance, and medical staff liaison functions.  It is with this experience that I come before you today to discuss medical errors, how technology can help reduce those errors, and the role that hospitals play in improving patient safety through these initiatives.

Madame Chairman, I would like to state, on behalf of the entire hospital community, how proud we are of the initiatives that hospitals and our staffs have already adopted to improve patient safety.  We look forward to working with you in the future as we continue to enhance our safety policies so that we minimize errors and continuously improve our care.  This hearing gives all of us testifying before you today an opportunity to share our insights with you, and with each other, so that together we can reduce medical errors.  As I’m sure my colleagues will agree, improving health quality and patient care is a team effort and we stand ready to do our part.

CREATING A CULTURE OF SAFETY

Hundreds of times a day, every day in today’s hospitals, health care is provided through a complex system that involves people, technology, medical devices, and pharmaceuticals.  This complexity has mushroomed in the past decade.  Preventing and reducing errors is therefore a very complicated task that never ceases.  Every medical error, whether or not it causes harm to a patient, must be detected and analyzed systematically in order to improve our ability to prevent these errors.

To prevent errors, we must create a culture of safety.  Most of what has been learned in recent years about how to reduce errors and improve patient safety is based on two guiding principles.  First, human beings, by their very nature, are vulnerable to error.  Although the individuals involved are sometimes the focus after an error occurs, we know that errors most often occur because of failures in the systems in which individuals work.  As a result, reducing medical errors will require us to develop and re-design the delivery of health care to build in error-resistant systems.

Second, we must create an environment in which we learn from our mistakes.  As a first step, we have to develop effective mechanisms for candid discussion of errors, something that cannot be achieved in an environment of punishment or fear.  Physicians, nurses, and other caregivers should not be penalized for stepping forward after a mistake has been made to report their error or an error they observed.  We need to create supportive systems both within health care organizations and through specific legal reforms.

Today, when health care providers share confidential internal information with health care oversight agencies, other hospitals, or outside experts, they may jeopardize the protection that state laws provide to internal quality analysis discussions and expose the institution and caregivers to crushing legal liabilities.  This legal “Catch 22” impedes efforts to share critical safety and quality information and analysis to prevent similar events from happening.  It is essential that carefully constructed federal confidentiality and evidentiary legal protections be developed to encourage a culture of safety based on candor and learning.  Further, reporting must be standardized and carefully defined.

The AHA continues to support federal legislation to address this issue.   In the Senate, there is an effort underway to address how the Congress could create an improved system for the voluntary sharing of patient safety information both with external experts and across health care delivery sites with adequate confidentiality protections.  We hope that this subcommittee will consider a similar approach in addressing health care safety issues.  It is vital that the Congress enact legislation that protects the analysis and sharing of adverse event and other patient safety information so that caregivers can uncover, analyze, and share their experiences and learning, without fear of reprisal.

At Danbury Hospital, we are committed to creating a culture of safety.  We have put in place a non-punitive reporting system that relies on intensive safety, education, and quality training.  We scrutinize any adverse event to understand the cause so that we can change our systems to prevent similar occurrences.  Further, we are committed to using new technologies that will improve patient care.

Medication errors are a critical concern for health care. We know from the research that roughly two-thirds of medication errors, those that reach or don’t reach the patient, occur in physician ordering and administration.[1]  We must have systems in place to make sure that important clinical information is available to physicians and pharmacists at the time drugs are prescribed.  Further, we must build systems that make sure the right patient is getting the right medication and dose at the right time.

There is extraordinary promise in reducing medication errors by using technology such as Computerized Physician Order Entry Systems (CPOE), bar-code technology, and drug administration systems, and through the development of standardized electronic medical records.  However, there are very important issues surrounding their availability and implementation.  Allow me to focus on CPOE and bar-coding as examples.

One way patient safety can be improved by information technology is through the use of machine-readable symbols such as bar-codes in a standardized format on all quantities of medication matching the right drug to a patient bar-coded identification.  Bar-code technology can enhance patient safety by ensuring there is real-time verification of the correct patient, medication, dose, and time.  The AHA is very supportive of efforts underway at the Food and Drug Administration (FDA) to promulgate regulations that would require human drug products and biologics to be bar-coded.  This effort will promote code standardization, which will successfully enable information systems that rely on the availability of bar-coded drug information.

In the area of medication ordering, CPOE systems have great potential to reduce prescription-based errors.  As you know, CPOE is a computerized system that allows physician orders to be entered directly into a computer, which simultaneously provides vital patient data and guidelines that give the physician valuable information as these orders are entered.  CPOE centralizes critical information, such as: the patient’s vulnerability to allergies, interaction with other drugs, standard dosing, recent pertinent laboratory data, prescribing tips, and standard or customized order sets.

At Danbury Hospital, I have spent considerable time carefully examining CPOE systems and, while I firmly believe that CPOE can reduce errors, reduce unnecessary variations in care, and improve staff efficiency, it is important to also recognize that these systems do not provide a single, “silver bullet” solution to drug prescribing errors.   We are committed to implementing CPOE over the next two to three years, but it will be an expensive and arduous road.  Let me share with you what I have learned about these systems.

The science of CPOE is still very new, except for the handful of larger academic institutions with home-grown systems developed over many years.  While about a dozen commercial systems are available today, many of these systems have not been tested widely and have not been tested in what would be considered a prototypical community hospital.  Although most of these health care organizations report significant quality and safety gains, in many instances, the cost savings are elusive, or at least difficult to quantify.  Further, CPOE systems are not standardized – there is no off-the-shelf system that can be purchased tomorrow and operated immediately.   It is important that the vendor community speed-up its efforts to create standardized systems that can be readily adopted so that hospitals can be assured that their investment will result in the care improvements anticipated.  This is also an area where there may be a role for federal research through the Agency for Healthcare Research and Quality.

It is essential that CPOE systems effectively interface with other information systems in use at the hospital.  Specifically, it is critical that these systems work with the pharmacy, laboratory, radiology, and medication administration systems already in place.  At Danbury Hospital, we have identified a problem with the interface between our CPOE vendor’s system and our current pharmacy computer system.  As a result, we will have to completely replace the pharmacy system at an additional cost of $500,000, adding six to nine months to our implementation plan.

In addition, the cost to implement such systems can be overwhelming.  For Danbury Hospital alone, we estimate putting in a CPOE system will cost $2.5 million over the next two-and-a-half years, a relatively low estimate because we have already purchased the software. Nor does this figure take into consideration annual maintenance costs of about $500,000.  For other comparable hospitals starting from scratch, the literature estimates a cost from  $5 to $10 million to fully implement an effective CPOE system

Hospitals face many challenges when it comes to implementing a CPOE system.  This is a massive undertaking, which for Danbury Hospital will require a significant amount of clinical and technical manpower over the next two years to successfully achieve our objective.  It is critical to the success of a CPOE system to have the commitment and active involvement of pharmacy, nursing, and medical staff.  Without the buy-in and participation of physicians and others, CPOE systems will remain unused or misused, and potentially create new sources of error.  This commitment means many hours of planning by key personnel, as well as massive education for the entire hospital staff.

In order to realize all of the goals of CPOE, be they reduced costs, improved quality, or most particularly improved safety, hospitals will need to redesign the work processes of their physicians, nurses, pharmacists, and technicians.  Short of embarking on CPOE, there are multiple other medication management strategies that hospitals can, and must, implement first, such as standardized orders, practice guidelines, formulary control, and computerized access to clinical information.  These strategies begin the consensus building process.  Suffice it to say that although we are committed to CPOE, it has been a tough decision to proceed, carefully weighed, and one that will occupy a great deal of our time and resources over the next two years.

Hospitals must also “own” and manage the system, which requires hands-on, expert information technology (IT) staff.  But it is important to understand the reality of hospitals’ financial situation.  Many smaller hospitals simply can’t afford to make the large financial commitment that maintaining such a level of IT staff support.  For hospitals that may have the available IT resources, many are currently over-taxed attempting to meet the obligations and deadlines set forth in the Health Insurance Portability and Accountability Act (HIPAA).

CPOE is just one example of a promising technology where stakeholders need to work together before widespread implementation is a reality.  But in many cases, successful implementation of new technologies will require further scientific advancement of the technology, worker buy-in, and capital to purchase needed technologies.  Hospitals are committed to using the best available technology within their resources to improve patient care and reduce medical errors.  Overcoming these obstacles will be critical to realizing the substantial benefits CPOE has to offer hospitals and the health delivery system as a whole.  We look forward to working with the Congress, the vendor community, and others to address these issues so that we may truly improve patient safety and save lives.

OTHER HOSPITAL CONSTRAINTS

While I know that the focus of today’s hearing is on how to improve patient care and safety, it is important to understand this issue against the backdrop of the larger health care context.  As this subcommittee is well aware, hospitals are facing unprecedented pressures that, when put together, threaten to erode the community hospital’s foundation.   Let me just touch on a few.

There is an alarming health care workforce shortage nationwide, with 168,000 open positions in hospitals alone.  Critical shortages in nursing and pharmacy positions hurt hospitals’ ability to successfully adopt new technologies, such as CPOE systems, which rely on the availability and expertise of pharmacy staff in particular.

Hospitals are also facing soaring pharmaceutical prices, with annual double-digit increases in cost.  Further, changes taking place in the legal system mean that hospitals and caregivers face considerable increases in professional liability coverage costs.  And, as you know, we are working to provide new equipment and training so that our hospitals will be prepared for any emergency, including the threat of bioterrorism.

In Connecticut last year, only a minority of hospitals had a positive operating margin.  Throughout the United States, one-third of all hospitals are operating in the red and another third are teetering on the edge financially.  It is vital that hospitals have adequate resources to meet the needs of their communities.  This means not allowing “budget-neutral” spending decisions to further reduce Medicare and Medicaid payments to hospitals.  And it means making improvements, such as the full Medicare inpatient inflation update, which will help us continue to meet the soaring demands being placed on us.

Further, teaching hospitals, such as Danbury, are facing a significant cut in our graduate medical education funds.  This scheduled cut must be eliminated if we are to continue providing sufficient resources to train the next generation of caregivers in the practices, and use of potential technologies, that can improve patient quality and safety for years to come.

Finally, there are nearly 40 million people living in the United States who do not have health insurance at all.  Medical studies demonstrate that the uninsured live sicker and die younger because they are forced to go without the medical help they need.  The men and women of America’s hospitals see every day the devastation and pain that are caused when people do not have coverage, causing them to come to us much sicker than they should.

CLOSING

For thousands of years, healers have lived by the motto “primum non nocere” – first do no harm.  The nurses, doctors, and others on the hospital patient care team strive every day to deliver safe, efficient, and compassionate care.  But in today’s complex, high-tech world of medicine, despite our best efforts, we can have unwanted and unintended consequences.  As good as our systems are for preventing and reducing medical errors of all kinds, we can and must do better.

It is important that we continue to focus on what it means to promote a culture of safety.  At AHA, and at Danbury Hospital, we are committed to these important issues.

You have heard testimony about creating a culture of safety at the Veterans’ Administration (VA) and received a statement regarding the airline safety reporting system run by the National Aeronautic and Space Administration (NASA).  There is much to learn from their successes in promoting a culture of safety, in particular through the creation of non-punitive systems for the reporting and sharing of adverse event information.

In our efforts to create a culture of safety, there is a role for technology, and in particular CPOE systems, to help prevent medical errors and improve care.  But we must be cognizant of technological, cultural, financial, and other challenges as we strive to provide the best possible health care to every patient that comes through our doors.  Again, it is important to remember that there is not one solution or one activity that will make our systems error proof.

We look forward to working with Congress, our colleagues, and the vendor community to address head-on the financial, technological, legal, and cultural issues that can help us cross what has been called a “quality chasm.”

[1] Leape LL, Bates DW, Cullen DJ et all. Systems Analysis of Adverse Drug Events.  JAMA 1995; 274:35-43.