You asked if federal Medicare and Medicaid regulations require hospitals to report medical errors. You also want to know if national accrediting bodies for hospitals require such reporting.

SUMMARY

Federal Medicare and Medicaid regulations do not specifically require hospitals to report medical errors. Program regulations do address certain "conditions of participation" by hospitals in these programs that include quality assurance programs and remedial actions to address deficiencies. The regulations also require hospitals to have policies and procedures to minimize drug errors.

The Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) requires the reporting of "sentinel events. " Such an event is an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. The JCAHO, which is an independent, not-for-profit organization that evaluates and accredits hospitals and other healthcare organizations, recently approved a new set of patient safety standards.

MEDICARE AND MEDICAID

Medicare and Medicaid program regulations do not specifically require hospitals to report medical errors. Acute care hospitals must meet general quality standards in order to participate in Medicare and Medicaid (42 Code of Federal Regulations (CFR) Sec. 482). The "conditions of participation" for these programs require that hospitals "protect and promote each patient's rights," including the "right to receive care in a safe setting" and `to be free from all forms of abuse or harassment" (42 CFR § 482. 13). Also, each patient has the right to "access information contained in his or her clinical records within a reasonable time" (42 CFR § 482. 13).

Hospitals participating in these programs must also "ensure that there is an effective, hospital-wide quality assurance program and take appropriate remedial action to address deficiencies" that are identified (42 CFR § 482. 21). Additionally, hospital medical staff must develop policies and procedures to minimize drug errors, assure that errors and adverse drug reactions are reported to the attending physician, and make drug safety information available to hospital safety personnel (42 CFR § 482. 25).

JCAHO STANDARDS

In July 2001, the JCAHO approved a new set of hospital patient safety standards that address a number of patient safety issues. These include implementation of patient safety programs; the responsibility of organization leadership to create a "culture of safety; " the prevention of medical errors through the prospective analysis and re-design of vulnerable patient systems (e. g. the ordering, preparation, and dispensing of medications); and the hospital's responsibility to tell a patient if he or she has been harmed by the care provided. JCAHO is considering implementing similar patient safety standards throughout its accreditation programs for other types of healthcare facilities.

These new standards substantially expand on existing JCAHO requirements that healthcare organizations (including hospitals) report "sentinel events," which are unexpected occurrences involving death or serious physical or psychological injury, or the risk thereof. "Serious injury" specifically includes the loss of limb or function. These events are called "sentinel" according to JCAHO, because they signal the need for immediate investigation and response.

JCAHO reviews the organization's activities in response to sentinel events in its accreditation process, including all full accreditation surveys and random unannounced surveys. Anytime a sentinel event occurs, the healthcare organization is expected to complete a thorough credible "root cause analysis," implement improvements to reduce risk, and monitor the effectiveness of those improvements.

Connecticut Public Act 02-125 (sHB 5715, "An Act Creating a Program for Quality in Health Care") references this "sentinel event" reporting. The act requires hospitals and outpatient surgical facilities to report adverse events to the Department of Public Health. "Adverse event" is defined to include "those sentinel events for which remediation plans are required by the JCAHO" (Sec. 3 of PA 02-125).

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