June 27, 2000

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The Senate Health and Human Services Committee met today to discuss "medical errors" and "patient safety." Sen. Connie Stokes presided over the Committee meeting. The discussion of this topic appears to be the result of the National Institute of Medicine’s report on medical errors. The Institute has found that one of the nation’s leading causes of death and injury are medical errors. These errors occur in every health setting – hospitals, ambulatory surgery centers, outpatient clinics, retail pharmacies, nursing homes, and home health care. Many of these errors are the result of medication errors – more than 50%. Sen. Stokes explained that her Committee would be holding additional hearings on this subject, largely to determine whether a mandatory or voluntary reporting system is needed for practitioners and healthcare organizations to report such errors as a means to correct the problem.

The first speaker, Hedy Cohen, was from The Institute for Safe Medication Practices ("ISMP"), a nonprofit organization which works with healthcare practitioners and institutions, regulatory agencies, professional organizations, and the pharmaceutical industry in providing education regarding adverse drug events and the prevention of same. ISMP also provides independent reviews of medication errors which have been submitted voluntarily by healthcare practitioners to a national database known as Medication Errors Reporting Program. This Medication Errors Reporting Program is operated by the United States Pharmacopoeia. Ms. Cohen stressed that ISMP is trying to get practitioners to safely prescribe, prepare and dispense medications. Most errors involving medications occur with older, sicker patients who are already prone to taking a lot of medication. Ms. Cohen also explained that many people have problems with over-the-counter medications. These errors have an impact on not only patients but also healthcare professionals. Ms. Cohen explained that there is a need for a confidential reporting system in order to have an expert analysis of the data collected. Thus, such collection of data would allow sharing of information on errors. She also discussed the concepts of mandatory reporting versus self-reporting of errors as well as a legal obligation versus an altruistic approach. Ms. Cohen stated that she feels that most healthcare professionals actually report to patients, as well as their families, errors which have occurred. She explained that it is believed that 40% of errors can be tied to lack of patient information.

Bill Clark, of the Medical Association of Georgia ("MAG"), also testified before the Committee. MAG is committed to practicing "good medicine." MAG, in partnership with others such as GHA (the Georgia Hospital Association), is looking at medical mistakes. This partnership is preparing a study on patient safety. Clark explained that MAG’s commitment to medical errors and patient safety began before this began developing as a national issue. MAG believes that the actual counting of medical mistakes will do no good.

The National Patient Safety Foundation’s ("NPSF") representative, Donald J. Palmisano, M.D., J.D., also testified. Dr. Palmisano’s organization is committed to improving patient safety, but everyone has to work together – patients, providers, manufacturers, etc. NPSF’s mission is to "identify and create a core body of knowledge; identify pathways to apply the knowledge; develop and enhance the culture of receptivity to patient safety; raise public awareness and foster communications about patient safety; and improve the status of NPSF and its ability to meet its goals." NPSF has held forums across the United States to address the collective actions on reduction of medical errors. These forums look at the development of strategies in the reduction of errors. Prevention of recurrent errors is also an issue. Medication dispensation to children is also being researched. The creation of a "culture of trust" is key as is a new dimension of accountability. Quality issues are also a major concern – this includes misdiagnosis as well as wrong-site surgery. Dr. Palmisano explained that 1) all stakeholders must work together on system problems (hospital CEOs have to embrace safety and this concept will then flow downward); 2) there must be a detection of systemic errors; 3) individual providers cannot be blamed; 4) mandatory or voluntary reporting must occur with an analysis of the data in order to find a solution (he also mentioned here the "hindsight bias"); and 5) support must be given for mandatory reporting and protections must be put into place to protect those making the reports. Dr. Palmisano also discussed accountability versus blame and the importance of discussing mistakes. Independent review and safe harbor provisions for workers who report such mistakes are also key. Dr. Palmisano stressed that the release of names to licensing entities could not occur. Finally, there have to be clear definitions for reporting systems. Dr. Palmisano believes that if providers talk to patients and their families about errors, there is less likelihood that they will sue over such mistakes or errors.

Mark Crafton of the Joint Commission on Accreditation of Healthcare Organizations ("JCAHO") also presented testimony. JCAHO is committed to safe delivery of care; thus, patient safety and medical errors are of great concern to his organization. JCAHO reviews incidents involving patient suicides, patient errors, post-operative complications, and wrong-site surgeries. The reason for under-reporting of events, according to Mr. Crafton, is fear. The fear of providers of job loss, ‘shunning’ by other professionals, regulatory issues, monetary fines, and litigation. Peer review and sharing of information is key. Protected reporting by way of state and federal legislation will help. States such as Louisiana and North Carolina have addressed these issues. JCAHO has 567 standards and 243 of these standards have directly relate to patient safety. JCAHO also sees the issue of no retribution or blame to ensure a pro-active program on safety. Thus, there must be the creation of a system which is a blame-free system; a credible system with follow-up monitoring; a system which allows dissemination of information; and a system that has the establishment of safety standards which must be met.

Commissioner Russ Toal of the Georgia Department of Community Health also spoke to the Committee. DCH is looking at human as well as financial costs associated with errors. DCH is reviewing data systems and looking at what healthcare the State is purchasing. DCH has restructured the way Georgia purchases healthcare as well as administrates certain programs such as the Composite State Board of Medical Examiners. Computer systems have been upgraded to keep up with credentialing of providers. Toal has been to Washington, D.C. to discuss patient safety and is also working on a workgroup within the Health Care Financing Administration on patient safety concerns. New Medicare regulations will be forthcoming for hospitals in an effort to reduce errors. Toal is also working with a group known as Leap Frog (made up of large corporations) which has no tolerance for error. Toal explained that there will always be adverse events and outcomes – but preventable error reduction is the goal. Toal expressed that the partnering with GHA and MAG by DCH is a good way to improve practices – it is also a volunteer effort with "teeth." Measuring data collected by DCH will also be key. Toal pointed to the State’s new PPO Network for State Merit employees which has quality oversight and disease management initiatives which will be forthcoming. Toal agrees that systems cannot cause doctors' reluctance to report - reasonable standards of participation are the key. HMOs must take on error reduction practices before they can contract to do business with the State.

Holly Bates Snow with the Georgia Hospital Association ("GHA") spoke to the Committee as well. Ms. Snow stated that "hospitals do not provide care – people provide care." Outcomes should focus on quality. Public and private initiatives are needed. If a system of reporting should be undertaken, either mandatory or voluntary, it should be done with caution. Ms. Snow also had with her representatives from DeKalb Medical Center, Floyd Medical Center, the Medical College of Georgia ("MCG"), and Morehouse School of Medicine.

Dr. Daniel Rahn with MCG pointed out that it is looking at restraint-related events as well as infection-related events. MCG also participates in a program known as MedMar. MCG is taking steps to improve quality but that requires all stakeholders’ participation. There are usually multiple causes to an adverse event. There should be an open sharing of lessons learned – across organizational lines. Dr. Rahn also believes that there is a need for a blame-free environment for professionals who report as well as a legally protected framework for dissemination of information.

The Georgia Pharmacy Association’s Wayne Oliver also testified. Oliver stated that 98,000 patients die each year in hospitals. Deaths in outpatient centers and nursing homes are not included in this number. There are approximately 7,000 deaths annually associated with medication errors. The costs associated with drug mortality is $76 billion. Oliver reminded the Committee that the cornerstone of healthcare delivery is drugs. Oliver alluded to the fact that patient safety and their investigations were already being conducted. This raises the question for the need for further mandatory or voluntary reporting of errors. Oliver did explain that there were certain things which could be done to impact patient safety such as more care given in the naming of drugs, patients having a better understanding of their role in treatment which will lower risks, requiring a medical diagnosis to be placed on the prescription, and improving or preventing handwriting questions on prescriptions (perhaps require typewritten prescriptions). Oliver also pointed out the positives of collaborative practice agreements which have been instituted for mid-level practitioners in prescribing.

David Tibble spoke to the Committee on behalf of the Georgia Society for Healthcare Risk Management. This group is a national organization with 145 members. Its goal is the reduction of medical malpractice claims. Thus, such reduction would then reduce the overall costs of providing healthcare.

Sen. Stokes explained that the next meeting on this issue would probably be sometime in September.