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A Public Letter to the Health Care Financing Administration with Respect to the December 19, 1997, Proposed Hospital Conditions of Participation in the Medicare and Medicaid Programs

March 31, 1998 

Health Care Financing Administration
Department of Health and Human Services
Attention: HCFA-3745-P
P.O. Box 7517
Baltimore, MD 21207-0517

Consumers, hospitals, health care practitioners, payers, and governmental agencies should collaborate to eliminate medication errors from hospitals. Unfortunately, we believe HCFA’s proposed method for reaching this goal will fall far short of achieving that intent. The current proposal represents poor public policy because it would (a) heighten fear among health care workers of reporting medication errors and (b) create the impression that the federal government sanctions mistakes in 2 out of every 100 doses of medicine administered to hospitalized patients. Consumers expect fail-safe, error-free hospital care, and that must be the aim of public policy. 

Instead of the proposed approach, we urge the agency to adopt a more effective requirement that is consistent with research findings and best practices in quality improvement. The approach we advocate is to require each hospital to establish and conduct an active, interdisciplinary quality-improvement program focused on medication error prevention and elimination. Minimum elements of such a program are the following: 

  1. A standard definition of medication error.      
  2. An ongoing process for measuring medication errors, following up on their root causes, and instituting safety mechanisms to eliminate repeated incidents.      
  3. A periodic, regular, interdisciplinary, and hospital-wide analysis of medication-use safety, coupled with education and training of relevant staff.      
  4. Identification of the inherently most hazardous aspects of medication use in the hospital and systematic efforts to reduce those hazards.      
  5. Reporting of serious medication errors to existing, voluntary national reporting programs in order to foster analyses of root causes of errors and dissemination of information on how to prevent such errors from occurring.
The initiation of active internal monitoring of serious quality problems in hospital care typically leads to an initial finding of more problems than expected. Appropriate follow up actions, however, then lead to sustainable improvements over time. We believe this approach would lead hospital administrators and health care practitioners to adopt the elimination of medication errors (not a 2% threshold) as their goal.

We stand ready to assist HCFA in crafting requirements that embody these principles.


Henri R. Manasse, Jr., Ph.D., Sc.D.
Executive Vice President and CEO
American Society of Health-System Pharmacists
7272 Wisconsin Avenue, Bethesda, MD 20814
Lucian L. Leape, M.D.
Department of Health Policy and Management
Harvard School of Public Health
677 Huntington Avenue, Boston, MA 02115
Donald M. Berwick, M.D.
President and CEO
Institute for Healthcare Improvement
135 Francis Street, Boston, MA 02215
Michael R. Cohen, M.S., FASHP
Institute for Safe Medication Practices
300 West Street Rd, Warminster, PA 18974-3231


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