7%. They also reported the 37.4% of medication errors were caused by wrong dose or frequency, which is not far away from our result of 50.5%. (Hui, Colombia Univ. no date given) The Harvard Medical Practice Study reported that adverse events occurred in 3.7% of hospitalizations in New York in 1984, and 69% of these injuries were caused by errors" (Kuperman, et al. 1998 as cited by Hui, Colombia University no date given) There were found to be more than 250 laboratory results that contained errors although generally there were not serious consequences resulting from the errors. A few did however cause serious problems as exampled by the instance in which the "patient was started tuberculosis medication due to wrong report of positive AFB" (Hui, Colombia University nd) This error was harmful on a potential basis due to the fact that an incorrect diagnoses or mediations given to the patient could have been harmful if not fatal to that individual. The cause for wrong results or errors in lab work may be due to one of the following: Pre-analytical: Samples from a patient in which there is a mixing up of the specimens with that of another individual.

Analytical: Map-operation of the devices; or Post-Analytical: The mixing up of patient data.

Stakeholders

Stakeholders are naturally concerned about patient safety as well as the development of strategies for identification and addressing threats to patient safety. The concern starts at the federal government and goes through the state and local governments and impacts public and private providers as well. State governments are able to "address the problem in a variety of roles, as purchasers, providers, and regulators, and others as well. Regulation of private health insurance, purchase significant amounts of health care as well as assuming responsibility for protecting the health and safety of the public.

A study published in 2000 by The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) summarizes the adverse events that are surgery linked over the past four years. There were 64 events that occurred in acute-care hospitals with 84% of the events resulting in the death of the patient and 16% resulted in the patient sustaining some type of serious injury. Ninety percent of these cases were of the nature of non-emergent type procedures. The majority of complications were found to have occurred during the 'post-operative period' with almost 25% during intra-operative procedures. The most frequent complications are inclusive of the following:

Naso-gastric feeding tube insertion into the trachea or a bronchus

Massive fluid overload from absorption of irrigation fluids

Acute respiratory failure during open orthopedic procedures

Endoscopic procedures with perforation of adjacent organs

Central venous catheter insertion into an artery

Liver laceration, peritonitis or respiratory arrest during imaging directed percutaneous biopsy or tube placement

Burns from electrocautery with a flammable prep solution

Eight 'root causes' for the problems were identified by the medical institutions. Incomplete communication was found to blame in nearly 2/3 of the cases as the 'root cause' with over 1/2 resulting from failure to adhere to procedures established in the hospitals. Other factors that were stated to be 'contributing factors' of:

1. Necessary personnel not available when needed incomplete pre-operative assessment inconsistent post-operative monitoring failure to question inappropriate orders inadequate supervision of house staff deficiencies in credentialing and privileging; and

2. Children and the elderly have been shown in the study to be much more vulnerable to medication errors than those of other age groups. An effective system to assist in the prevention of errors has been on the forefront of the minds of medical professionals since the release of the Institute of Medicine's 1999 report.

Each health care setting should have designated healthcare workers within its' institution that are in charge of the tasks of: 'Identifying and monitoring the occurrence of errors, and developing an understanding of their root causes, especially those that are preventable through,

1) Analyzing, interpreting, and disseminating data to clinicians and others in a position to effect changes within the organization;

2) Implementing error reduction strategies based on analysis and restructuring of health care systems; and

3) Seeking input as needed from experts with clinical, epidemiological, and management as well as, "

4) Training and experience for technical support and investigatory assistance; and finally evaluating the impact of these programs on patient safety.

There are several databases that are currently in use for the collection of information on specific errors. Examples of these are the Center for Disease Control and Prevention's hospital acquired infections reporting systems, The Food and

Also included are the Veterans Health administration and facilities within some states. Under reporting of events has been a problem which renders the system ineffective in reductions of medical errors. Stated in the report is the fact that: Effective programs need to incorporate protection from legal discovery and liability, which cause errors to be concealed." (Goulding, 2003)
Solution One: Mandatory Reporting Systems

Benefits

Original envisioning of mandatory reporting systems have not culminated with the heretofore dreamed of success. The Mandatory reporting system, while it certain has its potential in the production of useful data, as well as compliance with requirements of reporting systems. However, released data shows that there has been an inconsistency in the reports from the mandatory system has been 'inconsistent' (Institute for Safe Medical Practices, 2000) Benefits of the Mandatory reporting system are in two main areas. First the improvement or enhancing of patient safety is a very important benefit of this type of reporting system and secondly the awareness that this brings to the mind of healthcare providers ensures that they will be responsible in their provision of healthcare rather than suffer the consequences, or it is at least hoped that this is so.

Challenges

Challenges in the Mandatory reporting system are quickly acknowledged by any individual giving consideration to the system for error reporting since there are many questions of privacy matters.

Legal Protection of Error Information

Adverse consequences for those reporting errors exist creating a demand for systems that "incorporate incentives and safeguards" which are "likely to receive more and better data if the system is perceived as trustworthy and safe (OAHHS, 2000) Offering "confidentiality and some level of evidentiary protection for the information submitted" to these systems is suggested as being significant in terms of incentives. (OAHHS, 2000) Patient safety data would not be subject to any of the following:

A civil or administrative subpoena;

Discovery in connection with a civil or administrative proceeding;

Disclosure pursuant to a Freedom of Information Act request; or Admission as evidence or disclosure in any civil or administrative proceeding. (House Report 108-031, Part I: Patient Safety Improvement Act of 2003)

There is no proposal for the establishment of a national voluntary system of reporting medical errors in the IOM report. The Center for Patient Safety is a proposed center that has been "charged with oversight of this process." (OAHHS, 2000)

There are several options are available for voluntary system general design, recommends for ISMP as well as establishing or enhancing mini-systems targeted toward selected health areas stated to be "surgical events, anesthesia events, medication events, and pediatric events." Framework for the 'mini-systems' should be national in scope and voluntary in nature, as well as being confidential. The framework should be non-punitive towards those who report such errors and in relation to regulatory or accreditation entities the system should be independent of these. The framework of the 'mini-systems should be objective in terms of findings as well as using objectivity in recommendations in order to be embraced and receive support of the full healthcare community. The framework should be of a nature that is effective and credible in analysis and utilization of the information and should be timely and cover a large area through communications about errors and the prevention of errors. The framework should be of the nature that encourages "unrestricted practitioner reporting and should be able to receive reports of events that are either serious or fatal and caused by error, "near misses" as well as hazardous error-potential situations. The framework should last of all "encourage universal acknowledgment, adoption, and implementation of proven safety practices; and offer a level of evidentiary protection for the error information reported to it." (OAHHS)

Public Disclosure of Errors and Provider Accountability

As pointed out in the Institute of Medicine report, "healthcare providers have a moral and ethical obligation to disclose medical errors honestly and promptly" however this is not always the case. If disclosure were handled in a prompt manner then the financial risk taken on by organizations such as hospitals and clinics would be greatly reduced. The report states that:

"Providers and other participants in the healthcare process should be held accountable for the successful implementation of selected safety strategies that grow out of expert analysis of reported adverse events and scientific research. Reporting systems should not have the power to mandate implementation of recommendations that arise from analysis of adverse events." (OAHHS, 2000)

According to the Joint Commission on Accreditation of Healthcare Organizations, "meaningful improvement in…