Contact: Patient Safety Program



Legislation (COMAR 10.07.06) enacted in 2004 requires mandatory hospital reporting of serious adverse events; those that cause death or serious injury, defined as a physical or mental impairment that substantially limits one or more of the major life activities of an individual and lasts more than seven days or is still present at the time of discharge. The Patient Safety Program reviews the events and the submitted root cause analyses and provides feedback to hospitals on individual reports. 

Regulatory Requirements 
COMAR 10.07.06 defines the following requirements:
  1. Hospitals must appoint a patient safety officer.
  2. Patient and/or family must be notified of an adverse event.
  3. Report to Office of Health Care Quality within five days of becoming aware of a preventable medical error causing the death or serious injury of a patient.
  4. Investigation into the root causes or serious contributing factors (a root cause analysis or RCA).
  5. Some less serious events also must be investigated. Hospitals do not need to submit those analyses to the office.
  6. Submission of RCAs to the Office of Health Care Quality within 60 days of reporting.
  7. Inter-hospital notification if one hospital treats a patient believed to have been injured at another hospital.
  8. Confidentiality of patient safety-related hospital and Office of Health Care Quality work products is based on the medical review committee definition under Health Occupations Article, §1-401, Annotated Code of Maryland.  


Reports and Alerts

Information regarding trends, best practices, and lessons learned obtained from the review of reported events and root cause analyses are disseminated to hospitals and to the public via the Patient Safety Program’s Annual Report. The patient safety program also releases periodic Clinical Alerts and/or Clinical Observations on topics of interest. 

Tool Kit

The tools section contains the regulatory language and tools hospitals can use to report and review adverse events, including short forms for pressure ulcers and falls, requests to downgrade events, an event reporting form, and a sample RCA evaluation.