ASCLS

Medical Errors and Patient Safety

DOCUMENT: Medical Errors and Patient Safety
CLASSIFICATION: Position Paper
STATUS: Current (Approved by the ASCLS House of Delegates, August 2, 2001)

INTRODUCTION

In November 1999, the Institute of Medicine (IOM) released a report " To Err is Human: Building a Safer Health System ". The report estimated that 98,000 Americans die each year as a result of preventable errors. Death due to medical errors is higher than motor vehicle accidents (43,458), breast cancer (42,297) or AIDS (16,516). Approximately 7,000 patients are estimated to die from medication errors alone which is 16 % higher than deaths attributed to work related injuries. Even when conservative estimates are used, medical errors are the eighth leading cause of death.

BACKGROUND

Most of the evidence presented in the IOM report is not new data. However, the newly compiled information has heightened the public’s awareness of medical errors. According to IOM report, medical errors manifest themselves in an imperfectly designed system where mistakes are easily made. While the entire health care team must share responsibility for reducing errors and addressing safety issues, ASCLS has taken opportunity to provide leadership in this endeavor.

In its report, the IOM outlined four initiatives to prevent errors and improve patient safety:

RATIONALE

The parts of the testing process that occur within the walls of the laboratory have been the subject of quality control and quality improvement efforts for many years. Improvements in reliability of automated systems and careful attention to analytical procedures for both automated and non- automated analysis have reduced errors within the laboratory. Clinical laboratory scientists are the single group of health care professionals who are educated in the areas of quality control and can take a leading role in the development of positive error management. Laboratorians are responsible to collaborate with other health care professionals to look for ways to reduce errors and improve processes in the pre-analytical and post analytical portions of laboratory testing. This will involve collaboration with other health care professionals who may collect samples for laboratory and/or be the recipient of results.

This position paper reflects ASCLS commitment and interest in reducing the number of medical errors by supporting the IOM initiatives.

TERMS AND DEFINITIONS

The following terms and definitions were adopted by the IOM report:

Error: The failure of a planned action to be completed as intended or the use of a wrong plan of action. This definition was expanded during the First International Summit on Medical Errors and Patient Safety to "the failure of a plan of action to be completed as intended or the use of a wrong plan to achieve an aim." Errors can include problems in practice, products, procedures and systems.

Patient Safety: Patient safety applies to initiatives designed to prevent adverse outcomes from medical errors. An enhancement of patient safety includes activities in preventing errors known and visible, and mitigate the effect of errors.

Adverse Event: Unintended incidents in care that may result in adverse outcomes and may require additional care efforts.

Near Miss: Events in which unwanted consequences were prevented.

Sentinel Event: Event in which death or serious harm to a patient has occurred.

POSITION

ASCLS supports IOM’s recommendation for a nationwide reporting system of both mandatory and voluntary components.

A nationwide Mandatory Reporting System that provides gathering of standardized documentation of Adverse or Sentinel events could be linked to a system of accountability and made available to the public. A Mandatory Reporting System could be regulated at the state level, or could be responsible to the DHHS (Department of Health and Human Services).

A Voluntary Reporting system would complement the Mandatory Reporting System to identify precursors to errors. Information from the Voluntary Reporting System should be collected by an independent entity and used to identify patterns of errors. Peer review protection should be extended to the data collected related to patient safety and quality improvements.

ASCLS supports voluntary reporting systems and will serve to provide assistance in the planning, implementation and evaluation of programs addressing medical errors reduction and producing directives for the future.

ASCLS supports the establishment of coalitions at the state level designed to study medical errors within the state in order to provide recommendations to improve patient safety. A Clinical Laboratory Scientist should be seated on the committee.

ASCLS supports IOM's recommendation to raise the standards for health care professionals.

As a means of improving safety in the practice field, ASCLS collaborates with certifying, accrediting, and licensing bodies to review current information on medical errors in the context of current practice requirement. ASCLS formulates strategies for enhancing clinical laboratory science professional education in the area of error prevention. ASCLS supports the inclusion of error management education in the curriculum of health care professionals.

ASCLS supports collaboration with industry in the design and development of positive patient identification systems.

Positive patient identification will address a significant aspect of pre-analytic errors. A system of specimen identification, e.g., bar coding to be initiated at the time of first visit or admission, would reduce the clerical and identification errors associated with laboratory tests.

ASCLS supports collaboration with healthcare professionals to develop strategies to raise awareness in preventing errors in pre-analytical and post analytical testing processes.

Mechanisms should be designed to study the scope of medical errors within the laboratory setting and would identify and reduce such incidents. These tools should reflect scientific evidence-based information as well as personal experiences. Only by addressing all phases of the testing process will medical errors be reduced.

ASCLS supports provision of an environment that is conducive to the production of accurate, precise and timely laboratory results.

This environment should include adequate space, instrumentation, supplies, support staff, ergonomically sound design, and personal protective equipment.

ASCLS supports the development of new job classification in health care institution: Patient Safety Managers.

These managerial positions would be the resource for safe practices in patient care and would advocates for the clinical laboratory in the prevention of medical errors.

REFERENCES

1. To Err is Human: Building a Safer Health Care System. National Academy Press. 1999

2. Proceedings of the First International Summit on Medical Errors and Patient Safety. Washington, D. C. 2000

3. Governors Commission on Patient Safety. Michigan House of Representatives. 2000

CONTRIBUTORS TO THE MEDICAL ERRORS AND PATIENT SAFETY POSITION PAPER:

Brenda Bouchard

Karen Chandler

Bonnie Gum

Kathy Hansen

Myra Johnson

Shellie Smith

Leticia J. San Diego, Co- Chair

Donna Wright, Co-Chair