Rural Health and General Systems Theory

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Despite having unparalleled technology and resources, the US healthcare system has room for improvement. Impressive advancements in medical knowledge have accelerated at a mind-boggling rate, but knowledge and information distribution are ineffective and not readily available to the majority of providers. Innovative surgical procedures using advanced technology diagnostic equipment offer a sophisticated understanding of a patient's condition, but information distribution and communication is hampered by the manual, paper-based patient charts in most hospitals. The multiple people, departments, and processes that are an integral component of effective and efficient patient-centered care are typically lacking. Handwritten medication orders are error prone. Indeed, deciphering handwriting is frequently a challenge for those processing orders. Medications with similar names, but different action classes, effects, and dose ranges further complicate the medication management process.

The good news is that there are technologies available to rectify these challenges. Decision support systems offer the latest recommended clinical knowledge to assist clinicians as they evaluate, diagnose, and treat patients. Integrated, enterprise-level electronic medical records offer real-time access to clinical notes, procedures, test data, vital signs, allergies, medication history, and other medical information to the entire gamut of caregivers. Computerized physician

order entry (CPOE), combined with sophisticated alerts, can detect potential negative drug interaction dosage irregularities, conflicts with other medical problems, etc., and can greatly reduce errors.

Computerization in the clinical setting has focused on single- purpose applications. The proliferation of computerized clinical applications created an awkward collection of systems wherein pieces of patient data were stored in a variety of silos. As technology advancements occurred, new systems were often stacked on top of the old. Although this was originally intended to preserve familiar work processes, adding layers of functionality to already cumbersome and isolated legacy systems was similar to building a house of sticks — under the weight of additional layers the system began to crumble and collapse. The work processes related to these systems became burdensome and enhanced the potential for errors.

It is time for hospitals to take stock of their technology and applications and evaluate clinical workflow. If technology is applied to an inefficient manual process, it will retain its inefficiencies when automated. Technology, combined with clinical process transformation, holds the most promise for improvement.

Given the expense of an electronic medical record system, which includes physician order entry, medication administration records, and decision support systems, funding from the hospital supplemented by the federal government is needed. The events of September 11, 2001, and the subsequent threats of bioterrorism, have placed a spotlight on the inability of our nation's local healthcare delivery model to rapidly move patient-specific and organism/treatment-related

A Technological Approach to Enhancing Patient Safety

Kathleen Covert Kimmel, RN, MHA, CHE Joyce Sensmeier, MS, RN, BC, CPHIMS

KEYWORDS Electronic Medical Record

Computerized Physician Order Entry

Clinical Decision Support Systems

Clinical Workflow Processes

Adverse Drug Events

Patient-Centered Care

Bar Code Technology

Hand-held and Wireless Devices

The Institute of Medicine

The Leapfrog Group

data between and among hospitals and private physician practices. Just as the government built the national highway system after World War II because the existing road system was inadequate to move large numbers of troops rapidly across the country, the government needs to create a national health information infrastructure as a medical communication highway to protect its citizens.

DESCRIPTION OF THE ISSUE Processes to detect and reduce medical errors in hospitals and healthcare systems have been hampered by the lack of integrated technology and decision support applications. So, for many years, the extent of medical errors was unknown. Uncovering the degree of the problem was fueled by the medical error-related death of Boston Globe health columnist Betsy Lehman in 1994. Her death triggered a landslide of government hearings, meetings, and reports. Lehman, who was being treated for breast cancer at Boston's Dana Farber Cancer Institute, mistakenly received the cumulative dose of the cancer drug Cisplatin, instead of the daily dose for four days. The overdose caused heart failure. Post-event findings and analysis culminated in the release of the Institute of Medicine's (IOM) first report.1 In November 1999, the Committee on the Quality of Care in America produced a report titled "To Err is Human: Building a Safer Health System." This report shocked the nation by exposing a quality crisis, stating that between 44,000 and 98,000 hospital deaths each year are related to preventable medical errors.

The report concluded that: • the extent of harm that results from medical errors is

great; • errors result from system failures, not people failures; • achieving acceptable levels of patient safety will require

major systems changes; and • a concerted national effort is needed to improve patient

safety.

The IOM report recommendations set a 50 percent reduction in medical errors as a goal within five years, which could be achieved by:

• creating a Center for Patient Safety; • mandating a reporting system for medical errors; • encouraging voluntary reporting; • providing greater legal protection for data collected for

patient safety and quality improvement purposes; • promoting performance standards (people and

organizations) that emphasize safety; and • emphasizing safe use of drugs through the FDA.

In March 2001, the Committee on the Quality of Care in America produced a second report, "Crossing the Quality Chasm: A New Health System for the 21st Century." This report presents a call for action to improve the US healthcare delivery system.2

The Public Sector's Response to the First IOM Report Although there continues to be great debate about the actual number of errors, this report galvanized strong reaction from both the private and public sector. Within two weeks after the release of the first IOM report, the US Congress began a series of hearings. President Clinton ordered a government- wide feasibility study, which was followed in February 2000 by a presidential mandate to implement the IOM recommendations—specifically to reduce medical errors by 50 percent in the next five years. The President's mandate requires all 6,000 hospitals participating in the Medicare program to implement patient-safety initiatives, including medications and safety-oriented approaches.3 A Medicare Patient Advisory Commission report suggested that the Centers for Medicare and Medicaid Services (CMS), formerly known as HCFA, consider providing financial incentives to hospitals that adopt CPOE systems.4 The Agency for Healthcare Research and Quality (AHRQ) received $50 million to fund error-reduction research, including information-related strategies. The AHRQ produced a report, "Making Healthcare Safer: A Critical Analysis of Patient Safety Practices" in July 2001, which represented a first effort to approach the field of patient safety through the lens of evidence-based medicine.5

State governments have also responded to the IOM report. For example, the State of California passed a bill mandating that all non-rural hospitals implement CPOE by 2005.6

In the almost two years since the first report, the government has continued to address the problem. In May 2001, Senators Bob Graham (D-Fla.) and Olympia Snowe (R-Maine) introduced legislation to provide grants to hospitals and nursing facilities to implement technology that reduces medication errors. The Medication Errors Reduction Act of 2001 calls for nearly $1 billion in grants during the next 10 years, with $93 million available to hospitals and $4.5 million to skilled-nursing facilities each year. Under the bill, individual hospitals will be eligible for grants of up to $750,000, with grants for nursing facilities capped at $200,000.

A Technological Approach to Enhancing Patient Safety

The Fiscal Year '02 Appropriations Bill includes a 10 percent increase in funding for the Department of Health and Human Services, with $55 million set aside for AHRQ to determine ways to reduce medical errors. Additionally, $15 million has been appropriated for rural hospitals and designated for medical errors reduction and systems improvement to comply with provisions of the Health Insurance Portability and Accountability Act.7

The Food and Drug Administration (FDA) is implementing changes for the labeling of existing drugs, as well as testing new drugs before they hit the market.8 Mix-ups with look- alike or sound-alike drug names are a major source of medication-caused injuries and death. It is hoped that using a combination of eye-catching changes, including a mix of upper- and lower-case as well as different colored letters, will get the attention of pharmacists. In addition, FDA workers will begin testing groups of volunteer physicians, nurses, and pharmacists about potential confusion of new drug names before the drugs hit the market.

The Private Sector Response to the First IOM Report In addition to government agencies, the private sector has also responded to the first IOM report. The Leapfrog Group, a coalition of many of the nation's leading companies sponsored by the Business Roundtable, seeks to create meaningful, marketplace incentives to encourage the healthcare sector to adopt systemic quality improvement processes. The employer marketplace is responding to Leapfrog's message. In fact, the Leapfrog Group, joined recently by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), has grown from an original membership of 60 purchasers to more than 90 and now represents 25 million beneficiaries.

The Leapfrog Group has identified three initial patient safety standards as the focus for consumer education and information and hospital recognition and reward:

• reduce medication prescribing errors using CPOE; • refer patients undergoing certain high-risk procedures to

high volume hospitals); and • staff ICUs with intensivists (i.e., physicians certified in

critical care medicine).

Originally Leapfrog focused on encouraging providers to voluntarily adopt their recommendations. In June 2001, Leapfrog began taking action by using its economic clout to influence provider acceptance of the three recommendations. Approximately 900 hospitals in seven targeted markets

around the country (Atlanta, California, Eastern Tennessee, Michigan, Minnesota, Seattle, and St. Louis), are being asked how they process medication orders, staff their ICUs, and how many open heart surgeries they perform each year. The information will be available to millions of hospital-seeking beneficiaries via the Leapfrog Web site.9

The Leapfrog Group and First Consulting Group have released two new reports on CPOE. The first report is a guide to help hospitals assess the effectiveness of their CPOE systems in intercepting erroneous medication orders. The second report provides starter-set information for hospital decision makers to help them organize their CPOE effort and launch the search for an appropriate CPOE solution.10

Leapfrog's report card-like summary of a hospital's IT infrastructure is expected to help spark action by many providers. Financial analysts are anticipating a profound impact to healthcare IT spending as employers begin to shift market share toward providers who adopt Leapfrog's patient safety standards.11

The Leapfrog Group's efforts to impose economic sanctions to drive compliance are coming to fruition. In fact, by year- end 2001, General Motors was to have rewritten all of their payer contracts to require them to include patient safety requirements within their hospital provider contracts.12 This action puts the onus of responsibility of obtaining provider compliance with the health plans. Recently, a major health plan began attempting to encourage compliance by presenting financial rewards to providers who meet the safety standards. Three Fortune 500 companies joined Empire Blue Cross to recognize and reward hospitals that achieve the Leapfrog safety standards. As of January 1, 2002, hospitals in Empire Blue Cross and Blue Shield's networks receive a four-percent bonus for meeting two quality standards — CPOE and ICU staffing with intensivists. Hospitals that meet this standard beginning in 2003 willreceive a three-percent bonus, and those that wait until 2004 will receive a two-percent bonus.13

The Second IOM Report: Crossing the Quality Chasm The second IOM report decries a medical system where physician groups, hospitals, and other organizations "operate as silos, often providing care without the benefit of complete information about the patient's condition, medical history, services provided in other settings, or medications prescribed by other physicians."14 Harking back to their first report, this report again addresses patient safety problems, stating that the cause is a system that "relies on outmoded systems of work."

A Technological Approach to Enhancing Patient Safety

The solution for safer, high-quality care is to "redesign systems of care, including the use of information technology to support clinical and administrative processes.”

Recommendations on Restructuring the US Healthcare System The report includes 13 recommendations for restructuring the US healthcare system. While some recommendations pertain to quality of care, others discuss funding for monitoring and tracking existing solutions for quality of care. Also included are recommendations for mutual efforts between payers and providers to work toward a care system where patients and providers cooperate, collaborate, and share information that is current and evidence-based. Additionally, because 40 percent of all care is directed toward chronically ill patients, there are recommendations to identify at least 15 of the most prevalent chronic diseases and to develop strategies for improving quality of care for each.

The report also requests the AHRQ to facilitate further thinking by convening workshops designed to promote guidelines in specific topic areas. These areas include redesigning care practices, using information technologies to improve access to clinical information, supporting clinical decision making in an electronic environment, and coordinating care across patient conditions, services, and settings over time.

The Centers for Disease Control and Prevention (CDC) recently announced a collaborative effort with the E-Health Initiative to develop a much needed information technology infrastructure to combat bioterrorism. The initiative joins the CDC with a consortium of healthcare IT vendors and organizations that will link legacy IT systems in hospitals, pharmacies, and labs with the CDC National Electronic Disease Surveillance System (NEDSS). This effort is an important first step in facilitating the capture of critical data at the point of initial contact and transmitting disease surveillance information to the government.15

DISCUSSION/ANALYSIS

Medical Error Statistics The IOM's first report not only highlighted the number of deaths in hospitals due to medical errors, it also estimated the costs generated by those errors. National healthcare costs attributable to those deaths were estimated to be $8 billion annually.16 How extensive are medical errors? The National Committee on Vital and Health Statistics (NCVHS) reports

the following statistics: • One in 25 hospital admissions results in an injured

patient. • Three percent of adverse effects cause permanent

disabling injury; of these, one in seven leads to a patient death.

• Preventable medical errors account for 12 to 15 percent of hospital costs.

• About 23,000 hospital patients die each year from injuries linked to medication use.

• 80 percent of nurses calculate dosages incorrectly 10 percent of the time, and 40 percent of nurses make mistakes more than 30 percent of the time.

• Approximately 180,000 unnecessary deaths and 1.3 million injuries occur from medical treatment in the United States.17

Besides the IOM and the NCVHS, The Advisory Board Company in Washington, D.C., is another source for information on medical errors. The Advisory Board divides adverse effects into several categories. Each category is listed along with the number of times they occur per 1,000 hospital visits:

• 65 incidents are due to adverse drug events; • 60 incidents are due to nosocomial (hospital-acquired)

infections; • 51 incidents are due to procedural complications; and • 15 incidents are due to falls.

Adverse drug events (ADEs) top the list in frequency of occurrences. ADEs have a wide range of causes and careful measurement is a complex process.18 The second and third categories, nosocomial infections and procedural complications, may be related to provider training or experience and hospitals' infection control policies and procedures. The final category, falls, is usually related to unstable patients, including elderly patients, and can be traced to policies and procedures.

The average cost of an ADE is $4,700 per admission. When ADEs, which account for more than 25 percent of all adverse hospital incidents, are studied, the following results are found:

• 56 percent are attributed to physicians; • 34 percent are attributed to nurses; • six percent are attributed to unit secretaries; and • four percent are attributed to pharmacy staff.19

ADEs, the largest single category of medical errors, can be

A Technological Approach to Enhancing Patient Safety

immediately influenced by information technology. CPOE and bar code medication administration are two proven technology-supported work processes that can reduce medical errors in three of the categories listed above.20

While technology is a critical component to patient safety management, it should also be a part of an organization-wide strategy that includes workflow process redesign. Decreasing the number of ADEs requires the combination of clinical workflow transformation along with selective implementation of technology. Systems can be integrated and processes automated without solving the problem. Traditional workflows must be re-evaluated to harness technology and assist in information capture, flow, analysis, transmission, and trending.

CONCLUSIONS/RECOMMENDATIONS/POSITION STATEMENT

The Role of Technology A common theme throughout the IOM reports is the critical role information technology plays in reducing medical errors. In his statement before the subcommittee on Labor, Health and Human Services, and Education of the Senate Committee on Appropriations, Dennis O'Leary, president of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), stated, "Medical error reduction is fundamentally an information problem. The solution to reducing the number of medical errors resides in developing mechanisms for collecting, analyzing, and applying existing information. If we are going to make significant strides in enhancing patient safety, we must think in terms of the information we need to obtain, create, and disseminate."21 The Healthcare Information and Management Systems Society (HIMSS) is advocating for the use of information technology including point-of-care, unit-of-use bar coding to reduce medical errors and improve productivity.22 Evidence of the impact of technology is demonstrated by the Veterans Health Administration, which has seen a system-wide 75 percent reduction in medication errors since implementing bar code medication administration software.23 The American Medical Informatics Association also contends that errors can be prevented by computer systems that provide electronic patient records, physician order entry, practice standards, medical vocabularies, and computerized decision support.24

Economic Justification for Information Systems Technology Given the significant capital restraints now burdening healthcare organizations, purchasing this technology requires

a demonstrable return on investment. The good news for hospitals is that positive return-on-investment data related to some of these technologies already exists. An early study at an academic medical center estimated that CPOE generated savings of $5 to $10 million annually on a $500 million budget.25 A more recent study presented at the 2001 Annual HIMSS Conference and Exhibition provides evidence from Montefiore Medical Center, a 1,100-bed academic health system, of tremendous savings for CPOE and medication administration record — roughly $6 million annually. This figure combines the time savings for nurses, unit secretaries, and pharmacists.26

Table 1 uses data from the 2001 Hospitals & Health Networks third annual survey. The results indicate that the "most wired" hospitals, namely hospitals that have embraced technology solutions, have better control of expenses, higher

productivity, and more efficient utilization management than their peers.28 According to a report from Cerner Corporation, Samaritan Regional Medical Center saved $3 million annually and avoided 36 deaths by using a computerized data repository that was populated with medication rules.29 A 1998 study by the Gartner Group estimated a positive return on investment for ambulatory computer-based patient records. This report produced a formula for calculating the amount of savings per year/per physician by multiplying $41,400 per year/per practitioner to calculate the savings in an ambulatory environment.30

Technology is rapidly progressing. Electronic medical records with decision support at the time of order entry are improving each year in their features, functions, and capabilities. These

A Technological Approach to Enhancing Patient Safety

Table 1. Return on Investment Data Substantiates the Value of Investing in Technology 27

Attribute Technologically Other Hospitals Advanced Hospitals

Average length of stay 3.24 days 3.73 days

Highest AA credit rating 35% 15%

FTEs per occupied bed 3.3 3.8

Paid hours per 90.3 113.9 adjusted discharge

Net patient revenue $423,780 $164, 241 per discharge per discharge

Expenses per adjusted $3,995 $4,511 facility discharge

Annual increase in 0.6% 2.8% expenses

systems are justifying themselves in saving lives and money. Accessibility to mobile computing devices at the point of care is evolving. Wireless computing devices enable physicians, other ordering clinicians, and nurses to enter patient data at the patient bedside. Use of bar coding in combination with decision support assures that patients are receiving the correct medication or treatment. Utilizing CPOE, physicians are able to review up-to-date patient test results and other pertinent data prior to writing orders, as well as receive decision support while processing them.

Now is the time for a call to action for all healthcare stakeholders. Health plans need to provide the ordering physician with information on disease state management, efficacy of various drugs, and treatments at various stages of the clinical condition. The reference laboratory must supply results that offer guidance in the interpretation of the test and

support the physician in selecting additional tests or proper treatment. A four-way cooperative alignment between the ordering physician and the three major purveyors of information — the health plan, the reference laboratory, and pharmaceutical companies — is required. This can only be achieved when this information is available through decision support capabilities at the time of order entry. Orders may be entered using a hand-held device, wireless tablet, laptop, or desktop PC. Orders and results need to be immediately available to the physician, as well as to the entire treatment team at the hospital. This patient care team also needs to include the patient. Patients must be informed decision makers and active participants in their care. When all healthcare stakeholders recognize their responsibility and work together to address the patient safety issues, healthcare in this nation and all over the world will be vastly improved.

A Technological Approach to Enhancing Patient Safety

References

1 Committee on Quality of Health Care in America, Institute of Medicine, To Err is Human, National Academy Press, 2000. 2 Committee on Quality of Health Care in America, Institute of Medicine, Crossing the Quality Chasm: A New Health System for the 21st Century, National Academy Press, 2001. 3 The White House Office of the Press Secretary, Press Briefing by Senior Administrative Officials on President's Initiative to Reduce Medical Errors, February 22, 2000. www.pub.whitehouse.gov 4 Medicare Payment Advisory Commission. Report to Congress: Selected Medical Issues, June 1999. 5 Shojannia KG, Duncan BF, McDonald KM, Wachter RM. Making Health Care Safer: A Critical Analysis of Patient Safety Practices. AHRQ Publication 01-E058, July 20, 2001. 6 California Senate Bill No. 1875. Chapter 816, Statutes of 2000. 7 Healthcare Information and Management Systems Society. 2001 Congressional Review. Advocacy Dispatch, January 18, 2001. www.himss.org/about/advocacy.asp. 8 Daily Dose E-Mail. FDA implementing changes with new labels. Modern Healthcare, January 2, 2002. 9 Lovern E. Minding hospitals' business: Purchasing coalition pushes hospitals to improve patient safety through process measures, but industry says standards are too expensive. Modern Healthcare. May 28, 2001. 10 Kilbridge P, Welebob E, Classen D. Overview of the Leapfrog Group Evaluation Tool for Computerized Physician Order Entry. Leapfrog Group and First Consulting Group, 2001. 11 Falci RG, Steward RT, Weinberger A. An Update on the Leapfrog Movement: A Macro Catalyst is Maturing into a Fundamental Change Agent. Bear Stearns Equity Research White Paper, September 6, 2001. 12 Ibid. 13 Media Release Three fortune 500 companies join Empire Blue Cross and Blue Shield to recognize and reward hospitals that achieve Leapfrog safety standards. Empire BCBS, October 19, 2001. 14 Ibid. 15 Healthcare Information and Management Systems Society. CDC's ongoing push to create a national bioterrorism early warning system. HIMSS NewsBreak, December 24, 2001. 16 Beers JB, Berger MA. Medical Errors: Sources and solutions. Proceedings of 2001 Annual HIMSS Conference and Exhibition, session 17, 2001. 17 National Committee on Vital and Health Statistics. Testimony, June 23-24, 1999. 18 Bates DW, Leape LL, Cullen DJ, Laird N, Petersen LA, Teich JM, Burdick E, Hickey M, Kleefield S, Shea B, Vander Vliet M, and Seger DL. Effect of computerized physician order entry and a team intervention on prevention of serious medication errors. Journal of the American Medical Association. 1998; 280:1311-1316. 19 Clinical Initiatives Center Prescription for Change, Best Practices for Medication Management, Washington, D.C., The Advisory Board Company, (202) 672-5290. 20 Beers JB, Berger MA. Medical Errors: Sources and solutions. Proceedings of 2001 Annual HIMSS Conference and Exhibition, Session 17, 2001. 21 O'Leary D. Statement of the Joint Commission on Accreditation of Healthcare Organizations before the U.S. Senate and the Subcommittee on Labor, Health and Human Services and Education of the Senate Committee on Appropriations, February 22, 2001. www.jcaho.org/govt/oleary_02220.html. 22 Simpson N. Advocacy White Paper: Bar Coding for Patient Safety. Healthcare Information and Management Systems Society, December 2001. http://www.himss.org/advocacy/about/advocacy.asp

A Technological Approach to Enhancing Patient Safety

23 Johnson CL, Carlson RA, Tucker CL, Willette C. Using BCMA software to improve patient safety in Veterans Administration Medial Centers. Journal of Healthcare Information Management. 2002; 16:1, 46-51. 24 Bates DW, Cohen M, Leape LL, Overhage JM., Shabot MM, Sheridan, T. Reducing the frequency of errors in medicine using information tech- nology. Journal of the American Informatics Association, August 2001, 299-308. 25 Glaser J, Teich JM, Kumperman G. Impact of information events on medical care. Proceedings of the 1996 Annual HIMSS Conference and Exhibition, 1996. 26 Manzo J, Taylor RG, Cusick D. Measuring medication related ROI an process improvement after implementing POE. HIMSS News, February 2001. 27 Solovy A. The big payback: 2001 survey shows a healthy return on investment for into tech. Hospitals & Health Networks, July 2001, 40-50. 28 lbid. 29 Dennings EH. Healthcare Management Consultants. Cerner Corporation, June 22, 2001. 30 Duncan M. A simplified financial ROI for an ambulatory CPR. Gartner Group, October 1998.

Author Biographies

Kathleen Covert Kimmel, RN, MHA, is a consultant with IBM's Global Services, Healthcare Industry. She has a BS in nursing from the University of Massachusetts and an MHA from Duke University. She is a board-certified healthcare executive with the American College of Healthcare Executives. She currently serves as chair of the HIMSS Outcomes special interest group.

Joyce Sensmeier, MS, RN, BC, is the Director of Professional Services at the Healthcare Information and Management Systems Society (HIMSS). She is responsible for HIMSS advocacy efforts, certification, advancement, and the Integrating the Healthcare Enterprise initiative. Sensmeier is also a faculty member at Loyola University Chicago.

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