Proposed Rules Released December 19, 2008
On December 19, 2008 the Illinois Department of Public Health (“IDPH”) published in the Illinois Register the proposed rules to the Illinois Adverse Healthcare Events Reporting Law of 2005 (the “Never Events Law”). Interested persons may submit to IDPH comments concerning the proposed rules through Monday, February 2, 2009. The Never Events Law was scheduled to take effect January 1, 2008; however, both publication of the rules and appointment of the mandated statewide advisory committee were delayed. In April 2008, IDPH appointed the committee, which assisted with writing the rules and will assist in administering the Never Events Law.
Requirements of the New Reporting System
The Illinois legislature passed the Never Events Law as part of the Hospital Assessment Act of 2005. The stated purpose of the Never Events Law is to educate both health care providers and consumers about the weaknesses of the health care system. Ultimately, the new reporting system established under the Never Events Law is intended to facilitate medical error identification, error analysis, and reduction of medical errors.
Specifically, the Never Events Law requires hospitals and ambulatory surgical treatment centers to report to IDPH any of the 24 adverse events enumerated in the rules within 30 days of discovering the event. The rule organizes adverse events into six categories: (1) surgical events, such as surgery performed on the wrong body part; (2) product or device events, such as the use of contaminated drugs or devices; (3) patient protection events, including an infant discharged to the wrong person; (4) care management events, such as patient death due to inappropriate medication administration or dosage; (5) environmental events, including patient death or disability associated with a burn incurred while being cared for at the facility; and (6) physical security events, such as any instance of care ordered by a person impersonating a physician, nurse, pharmacist, or other licensed healthcare provider.
Under the Never Events Law, when a defined adverse event occurs within a covered facility, that facility will be required to self-report the adverse event. It must disclose the facility’s identity, but not the identity of the health care professionals, facility employees, or any patient associated with the adverse event. IDPH will publish the facility’s name and the reported event in an annual report, discussed further below. The proposed rules state, however, that no documentation submitted to IDPH may be discoverable or admissible in any civil, criminal, or administrative proceeding and no disclosure under the Never Events Law may contain identifiable information of a patient, employee, or licensed professional.
The Never Events Law also requires facilities to conduct a root cause analysis of the adverse event and implement a corrective action plan to address the findings of the analysis or, alternatively, report to IDPH the reasons for not taking corrective action. The root cause analysis and a copy of the corrective action plan must be filed with IDPH either at the time the adverse event is reported to IDPH (i.e., within 30 days of discovering the event) or within 90 days of reporting the adverse event to IDPH. Further, the facility must submit follow-up reports to IDPH both four and eight months following initiation of the facility’s corrective action plan.
IDPH Responsibilities and Annual Reports
The Never Events Law requires IDPH to collect and analyze data from the health care facilities’ adverse events reports and provide prevention recommendations to Illinois health care facilities. Additionally, the Never Events Law requires IDPH to publish an annual report for the public that describes the adverse health care events reported by each facility. The annual report will also summarize, in the aggregate, all submitted corrective action plans and findings of root cause analyses. Further, IDPH must describe in its annual report recommendations for quality improvement practices.
Six-Month Pilot Program
Once the public comment period ends and the rules are adopted and effective, IDPH is required to conduct a pilot reporting program for at least six months during which health care facilities will report adverse events to IDPH under the new reporting system. IDPH will not publish information reported and analyzed during the testing program. The pilot program is intended to test the new reporting system and identify any problems or deficiencies before IDPH fully implements the reporting system. IDPH may modify the reporting system once the pilot program has ended and must give at least 30 days written notice to healthcare facilities prior to full implementation of the new reporting system.
Enforcement
A health care facility that fails to comply with the requirements of the Never Events Law may be found in violation of the Illinois Hospital Licensing Act and, thus, may have its licensed denied, suspended, or revoked. An ambulatory surgical treatment center that fails to comply with the Never Events Law may be issued a fine.
If you have any questions about the new regulation or how it might impact you or your facility, please contact us.