Reducing Medical Errors: A Review of Innovative Strategies to Improve Patient Safety.

Subcommittee on Health
May 8, 2002
10:00 AM
2123 Rayburn House Office Building 

Mr. Ken Freeman
Chairman & CEO
Quest Diagnostics Incorporated
One Malcolm Avenue
Teterboro, NJ, 07608

Mr. Chairman, thank you for the opportunity to speak with you this morning about a subject near and dear to my heart - improving patient safety in America.

I'm Chairman and Chief Executive Officer of Quest Diagnostics, the nation's leading provider of diagnostic testing, information and services. We operate 30 full-service laboratories across the country and in Mexico and the U.K., as well as more than 1,350 conveniently located patient service centers, where doctors send patients to have specimens collected, employing more than 30,000 people.

Today I am testifying on behalf of Quest Diagnostics as well as the Healthcare Leadership Council, or HLC. HLC is a coalition of chief executives from all disciplines within the healthcare system that meets to jointly develop policies, plans and programs to achieve our vision of an effective 21st century healthcare system. I will briefly describe the HLC's patient safety initiative and then describe what my company-Quest Diagnostics-is doing to reduce errors, thereby improving quality and safety.

The Healthcare Leadership Council's Chief Executive Task Force on Patient Safety was created so that all sectors of the healthcare industry could work together to help elevate public confidence in the safety of the nation's healthcare system. HLC members have been active in seeking to improve safety for a long time and their efforts represent a broad range of ongoing programs. I have attached to my statement a brief description of some of these programs, as well as HLC's principles on patient safety, which I would like to submit for the record.

Coming from all facets of healthcare, each HLC member company is addressing different safety needs in the healthcare system, while adhering to a common set of guiding principles. For example, we believe that solutions should be developed collaboratively and with senior executive responsibility and leadership. If the CEO isn't the most passionate advocate of a patient safety initiative, it simply will not happen.

We believe that a holistic quality assessment system must be developed and adopted for use in healthcare, because errors are caused by bad processes, not bad individuals. Improving quality requires that we improve processes, based on facts and data that are not always easy to collect. Safe practice standards should be evidence-based, and appropriately flexible. Again, we must analyze the data to identify ways to improve practice standards - the "processes" - that are causing the errors. Finally, HLC members strive to establish a culture of awareness-NOT blame-to drive sharing information about healthcare errors in an open manner. It all starts with acknowledging the opportunity for improvement.

At my own company, Quest Diagnostics, we have incorporated these concepts into our own Six Sigma initiative to help take us to the next level in improving quality and safety. The Six Sigma approach has paid dividends for countless manufacturing companies during the past twenty or more years, including General Electric, Texas Instruments, and Motorola.

We are the first major company in healthcare services to pursue Six Sigma, and have been underway for more than two years. Six Sigma is already changing Quest Diagnostics, and I am absolutely convinced that it will ultimately change the world of healthcare quality and safety for the better, forever.

During today's hearing, you will learn about many fascinating and important technology solutions that will reduce errors and improve safety. But technology can only be as effective as the processes that employ it. The Six Sigma approach is a philosophy and a type of analytic thinking that can permeate an organization and drive behavioral change. Quality, safety, effectiveness and efficiency go hand-in-hand. Improving quality and safety is not only a moral imperative for us, it also makes solid business sense.

We have made a significant investment to provide foundation training for virtually all of our employees, and we have extensively trained almost 200 Six Sigma experts called Black Belts. These experts are leading more than 200 distinct defect-reduction projects, with several dozen having been completed. Six Sigma is a statistical measure representing virtual perfection, defined as 99.9997% quality, or no more than 3.4 errors per million opportunities. Our pursuit of Six Sigma quality is in its early stages and we also have much more to achieve. But we are making great progress.

One of our most successful Six Sigma projects has focused on improving the effectiveness of our specimen-handling process, to reduce the number of misplaced specimens for testing. When we started, this process already reflected a high level of quality. Now, in our business units that have implemented the new process, it nears perfection.

In another Six Sigma project we collaborated with hospital customers to reduce specimen collection errors that were causing nurses to re-draw blood from premature infants in neo-natal intensive care units. These errors delayed diagnoses and subjected fragile, tiny patients to needless trauma. The root cause or reason was that the ICU nurses had never been properly trained in sample collection. Designing and implementing a simple training course to standardize on the best procedures for the draw made an enormous difference for premature infants and their families.

In another Six Sigma project we developed a new standardized medical report using the Six Sigma process - starting by listening to the voices of our physician clients. The report is easier to read, lets a doctor identify abnormal results more readily, and shortens the time required to review reports, reducing the likelihood that a doctor will misinterpret a test result.

We provide a critical healthcare service. Diagnostic test results drive more than 70% of healthcare decisions, but represent only about 4% of total healthcare spending in the U.S. Every day, doctors and hospitals order diagnostic tests to diagnose, treat or monitor the treatment of millions of patients - tests that are performed by the nation's 10,000-plus independent and hospital laboratories. Early detection not only saves lives, it also saves money.

There is no looking back. The patient quality movement is gaining momentum among healthcare services providers. More companies and institutions are starting to discuss quality improvement in healthcare. And it's about time - this is the megatrend that we collectively must act on - for the sake of patients.

In closing, I am confident that together the healthcare industry, including my fellow members of the Healthcare Leadership Council, is rising to the challenge, recognizing the opportunity to drive quality improvement, and taking action by measuring defects and analyzing and improving the many processes that cause them. This is the right thing to do for patients and their families, and it is also good business practice.

Once again, thank you for the opportunity to speak with you this morning.

he Healthcare Leadership Council's Chief Executive Task Force on Patient Safety was created so that all sectors of the health care industry could work together to help elevate public confidence in the safety of the nation's health care system. We are accomplishing this by uniting behind a self-initiated protocol for addressing patient safety in the health care system responsibly, positively, and tangibly. The HLC task force is guided by the following principles:

Solutions should be developed collaboratively and with executive responsibility and leadership. A zero error medical environment will require devoted, thoughtful and creative collaboration of ALL STAKEHOLDERS: Care givers must increase awareness of the potential for errors, administrators must facilitate systems of improvement, patients must be committed to complying with treatment programs, industry executives must make patient safety improvement a declared and serious aim by establishing programs with defined executive responsibility, and lawmakers and regulators must resist mandates that could stifle innovative problem solving.

A holistic quality assessment system must be developed and adopted for use in health care. Individuals are not the true source of errors in health care or any other industry. Systemic review of processes, practices and policies to uncover sources of error so the source of those errors can be eliminated is essential for improving safety in the health system. The health care system should incorporate the lessons learned in other industries that have greatly reduced their error rates.

Safe practice standards should be evidence-based, flexible and feasible. Nationally recognized safe-practice standards should be developed only through analysis of conclusive data on broad-based effectiveness and feasibility, and should consider evolving science. In addition to recognizing broad-based safe practices, health care organizations should be encouraged to and should be recognized for adopting tailored safe practice programs unique to their specific risk points, specialties, and patient populations.

Healthcare organizations, lawmakers, and other policy officials should support the automation of patient safety systems to the greatest extent possible. The Institute of Medicine is urging a new generation of patient safety systems that are automated, information system-based, and technologically driven. A voluntary health system information technology infrastructure should be encouraged and facilitated as broadly and rapidly as possible to help reduce incidence of human error in the practice of medicine.

Establish a culture of awareness-NOT blame-to drive health care errors into the open. Improving patient safety depends heavily on the ability to collect and analyze patient safety data, and to use that information to develop safer systems. Laws that perpetuate litigation are antithetical to the goal of transforming medical adverse events and "near misses" to permanent and pervasive systems improvements. Lawmakers should carefully consider any new laws or regulations that could actually do damage to the current health care system by making errors and "near misses" even harder to identify. Peer review protections should be instituted to protect organizations from the fear of litigation which will prevent the sharing of information.

A system of incentives is the key to patient safety. Using positive incentives to encourage health care organizations and all care providers to swiftly report health care delivery problems and to develop processes and procedures to prevent further errors in the area is the key to improving the safety of health care system.

Focus on prevention instead of errors. Instead of devoting major efforts to medical errors after the fact, develop a system focused on studying near misses, to prevent adverse events in the first place. This focus should be firmly impressed early on in graduate medical education programs as well as training programs for all types of health care professionals.

Consider the larger context. The cause of -- and solutions for -- adverse medical events must be considered in full context beyond the individual incidents that result in medical errors:

A hyper-regulated health care environment is not conducive to patient safety. Coping with more than 111,000 pages of complex Medicare rules, guidelines and instructions reduces the amount of time and attention left for providers to focus on their patients.

A litigious health care environment is not conducive to the promotion of awareness and information sharing necessary to understand and avoid medical errors.

A price-controlled health care environment reduces the ability for health care organizations and systems to implement the necessary technology that can positively affect patient safety.

Abbott is helping to reduce medication errors through continued innovation in drug products. Abbott helped pioneer the availability of premixed solutions and prefilled syringes to minimize mixing and handling errors. Abbott also has developed numerous design and safety improvements for medication administration, including a pre-filled bar-coded syringe which automatically programs infusion pumps, helping to avoid medication errors caused by manual programming. Abbott also develops and continually improves products that protect against needlestick injuries.

In addition, Abbott has a error-reducing label enhancement program that includes color coding to help differentiate between products, printing on the backside of IV containers to ensure clinicians see all appropriate information, and machine readable industry standard bar codes on unit-of-use products.

Using Abbott's own clinical nurse consultants and partnerships with independent third parties, Abbott's support has made it possible for hundreds of health care professionals to complete continuing medical education programs developed by Abbott in cooperation with the Institute for Safe Medication Practices.

Ascension Health, the nation's largest non-profit hospital system, has numerous hospitals nation-wide which have implemented patient safety programs unique to their specific needs. Examples include:

Columbia-St. Mary's Hospital of Milwaukee, Wisconsin asked all clinical staff to complete a survey on medical errors. Over 400 responses offered many narrative comments on areas where the hospital excels in safety as well as areas in need of improvement. The survey prompted increased organizational communication with all clinical staff which is providing valuable information on how to improve the hospital's culture of safety. One project resulting from the survey is a leadership patient safety rounds pilot program to assess safety throughout the hospital.

St. Vincent's Medical Center of Bridgeport, Connecticut conducts a similar leadership rounds program to speak with front-line staff in a non-punitive way to discover "near misses" and to rapidly initiate changes to prevent recurrences.

Western Maryland Health System of Cumberland, Maryland has adopted several new medication-related programs, which include a non-punitive computerized medication event-reporting system, a computerized adverse drug reaction surveillance system, a patient Warfarin education program conducted by pharmacists, and computerized, patient-specific physician alerts for "black box" and other FDA-related drug warnings.

St. Agnes Hospital of Baltimore, Maryland has established the MICROMEDEX system on their Intranet which provides detailed monographs on drugs, alternative medicines, toxicological management, reproductive risks, and interactions, among others. This system is used extensively by medical and pharmacy staff to reduce medication errors. In addition, St. Agnes invested $1 million in state-of-the-art patient beds which have alarms to prevent patients from falling, allow patients to sit up in bed to avoid bed sores, and allow patients to be weighed in bed by built-in scales.

The AUTROS Point of Care System, developed by Baxter, is the first automated medication management system that combines medication bar-coding and wireless technology to link physicians, pharmacy and nursing at the point of care. This solution set integrates drug delivery products with the information required to ensure safe and effective delivery of medication. The clinical decision supports and accompanying alerts and warnings of the system is delivered through a wireless network, which supplies data in a way that improves clinician workflow, as it supports the clinicians as they deliver patient care under increasing time and cost pressures.

This integrated patient management solution provides instantaneous decision support at the bedside to ensure the five rights of patient safety: the right patient, the right medication, the right dose, the right time, and the right route; together, these facilitate the right outcome.

BD (Becton, Dickinson and Company) is well known for its health care worker safety initiatives designed to reduce the incidence of sharps injuries. In addition to these initiatives, BD takes a systems approach to two key and highly interrelated processes that directly impact patient safety: the pre-analytical laboratory specimen process and the medication administration process.

Accurate Lab Specimens: The majority of erroneous laboratory results - which can lead to the prescribing and administration of inappropriate and perhaps harmful treatments - are caused by mis-identification of specimens at the point of collection. BD helps eliminate these errors by providing an affordable and comprehensive system that includes process analysis and redesign, root cause error analysis, a unique line of bar coded specimen containers, hand-held and bar code enabled computer technology, and management reports that allow hospitals to track and measure the results achieved with the system. These components have demonstrated specimen error reduction by an average of 79 percent, and have improved safety through the reduction of medication, transfusion, and other errors.

Bedside Identification: The last opportunity to halt medication errors is at the point of administration, or the patient's bedside. Designed to halt medication errors at the point of administration, the BD Rx System uses hand-held and bar code enabled computer technology to identify the system user, the patient, and the drug prior to administration. This ensures compliance with the clinician's order and safe medical practice.

The Cleveland Clinic's widely acclaimed "POEMs" (Prevention of Errors in Medicine) Initiative is based on the premise that each specialty and practice group understands error-prone links in its own clinical work better than any administrative body. The Cleveland Clinic's POEMs task force has had each component within the Clinic contemplate medical errors encountered in that specialty's duties, or "near misses" experienced or heard about in its specialty. As part of this process, each department chairman was directed to discuss the issue and the project at all staff meetings and to encourage the solicitation of specific activities and procedures that represent potential error-prone processes germane to that department or specialty.

Each department determined and ranked its top 2-3 specific error-prone processes. An internal departmental working group then developed appropriate interventions and strategies to mitigate potential errors.

A group of hospitalists at Our Lady of the Lake Regional Medical Center in Baton Rouge, Louisiana, led by Dr. Richard Slataper, has developed a tracking and reporting tool to promote evidence-based treatment. This is a hybrid system of paper and computer technology. It uses a customized data collection program from Pendragon Forms written for hand-held computers. This tool has already been successful in improving the use of ACE inhibitor therapy in patients with chronic heart failure. Current plans are to expand to other areas such as coronary artery disease, stroke, diabetes, hypertension, vaccinations, code status and living wills, pain assessment, restraint use, smoking cessation, and deep venous thrombosis prophylaxis.

Merck has undertaken several initiatives to reduce medication errors in both the inpatient and outpatient settings. Examples include:

Inpatient: Merck has introduced color-coded unit dose blisters to aid clinicians in distinguishing different doses of the same medication and to minimize dispensing errors. Merck also has voluntarily placed National Drug Code bar codes on virtually all hospital unit-of-use products to aid hospitals choosing to use drug identification technologies.

Outpatient: Because patient under- or over-dosing is an important source of medication errors, Merck has developed innovative packaging for some products that includes a simple calendar that can be personalized to help patients remember when they should take their next dose. The special pack also contains a user-friendly patient leaflet (in addition to the more technical leaflet for pharmacists and doctors) to help inform patients about their medicine and their condition to improve compliance with treatment.

Premier's Clinical Performance Initiatives (CPI) seek to improve the quality and safety of health care and reduce costs at its more than 1,800-member nonprofit hospitals. This is done through the use of evidence-based best practices that are implemented for widespread use. Each year-long collaborative effort between the CPI staff and representatives from Premier hospitals includes: face-to-face meetings and conference calls with CPI project directors, medical experts, and statistical analysts who guide Premier hospitals through clinical improvement processes; site visits by Premier's CPI staff to learn the specific needs of hospitals; networking among hospitals to overcome barriers and share successes; and analysis of data submitted by each hospital to Premier's Perspective^TM database, a national warehouse of clinical data. Premier experts analyze this data to help hospitals identify ways to improve health services while reducing costs.

VHA offers its member hospitals Patient Safety Team Training, a product focused on improving patient safety, patient satisfaction, and performance in the emergency or labor delivery departments. VHA's Patient Safety Team Training uses proven methods based on aviation crew resource management techniques employed in that industry. Grounded in two decades of research and development, this training process was evaluated at 12 leading health care organizations over two years. Effectiveness results included fewer observed clinical errors, minimized litigation costs, and enhanced ability to achieve compliance with patient safety standards of the Joint Commission for Accreditation of Healthcare Organizations as well as with the IOM's 1999 patient safety recommendations.

Under this program, a VHA physician and nurse who have expertise in team training implementation in the high-performance, high-stress care environment first conduct an on-site assessment of an organization's readiness. They then conduct "train the trainer"sessions where select physicians and nurses in the organization learn to present the core curriculum to all staff members, bring about a culture change in their department, and reinforce team work behaviors using facilitated leadership and coaching.

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