The Office of Certificate of Need and Healthcare Facility Licensure in the Health Facilities and Licensing Division of the Senior Services and Health Systems Branch of the Department of Health and Senior Services (Department) proposes to amend N.J.A.C. 8:43G-7A.6, Primary Stroke Center Continuous Quality Improvement.

The proposal would require all general hospitals licensed by the Department and designated as either comprehensive or primary stroke centers to submit patient-level stroke data to the Department in order to establish an Acute Stroke Data Registry.    The proposal would require the submission of patient-level data that are consistent with other stroke data registries.  These registries include the American Heart Association/American Stroke Association’s Get with the Guidelines, the Centers for Disease Control and Prevention’s Paul Coverdell’s National Acute Stroke Registry, and Beacon Health Informatics’ Qualworx Stroke Registry.

The Department would act as the repository for the stroke data.  The data that is submitted would contain medical information collected on patients evaluated for stroke and patients who receive acute stroke interventional therapy, including:  hospital identification and patient demographic data;  pre-hospital emergency medical system data; hospitalization data;  imaging information;  symptom timeline;  thrombolytic treatment;  non-treatment with thrombolytics;  medical history;  in-hospital procedures and treatment; other in-hospital complications; and discharge status.

The stroke data submitted to the Department would be kept confidential and would be used by the Department to evaluate the treatment of stroke patients and to improve the quality of care for stroke patients.

The stroke data would be submitted on a quarterly basis by both the State’s designated comprehensive and primary stroke centers.    The proposal requires that the patient-level data be submitted by e-mail as an encrypted electronic file, or on a computer disk mailed to the Office of Health Care Quality Assessment.    

         The proposal appears in February 2, 2009 issue of the New Jersey Register.

       The public has until April 3, 2009 to comment on the proposal.  Persons wishing to comment on the proposal must submit their comments in writing to Ruth Charbonneau, Director, Office of Legal and Regulatory Affairs, New Jersey Department of Health and Senior Services, PO Box 360, Trenton, NJ 08625.  Written comments on the proposal must be postmarked on or before April 3, 2009, which is the close of the 60-day public comment period for the proposal.