The Patient Safety Act, (N.J.S.A. 26:2H-12.23-12.25) establishes the statutory framework for a new mandatory reporting system for certain adverse events that occur in any New Jersey health care facility licensed pursuant to N.J.S.A. 26:2H-1, et. seq. The New Jersey Department of Health and Senior Services (the “Department”) is in the process of developing rules and new reporting procedures to implement this Act. Nevertheless, the Department has required hospitals to begin using the Act’s mandatory reporting standards on an interim basis, effective February 1, 2005. The new standards require New Jersey general hospitals to report every “Serious Preventable Adverse Event”. The Department has expanded upon the types of events that must be reported, and has changed the reporting system for such events. The Department now requires the initial report of a Serious Preventable Adverse Event, and a follow-up report of a Root Cause Analysis. The new standards and interim procedures apply to every New Jersey general hospital, including its main campus as well as all ambulatory care and satellite facilities that are on the hospital’s license.

The Department’s mandate to use the Patient Safety Act’s reporting standards and the new interim process, in advance of the adoption of new rules, has caused some confusion among health care facilities throughout New Jersey. Some of our clients have requested guidance on the Act, and their duties and responsibilities under the new reporting standards and procedures. Some of the frequently asked questions and answers are as follows:

Q: If final rules have not been adopted, then how can the Department require hospitals to comply with the reporting standards?

A: Hospitals have been required by rule for a number of years to report a wide range of events. The Department is revising the reporting system, consistent with The Patient Safety Act, but it has implemented an interim process based on its regulatory authority for oversight of hospitals. The Interim Mandatory Patient Safety Reporting Requirements for general hospitals became effective February 1, 2005.

Q: How do the interim reporting requirements affect the already existing reporting requirements?

A: The new reporting process will replace the Department’s already existing guidance as set forth in a Memorandum dated May 5, 2003, from then Commissioner Lacy to hospital CEOs, only as it relates to Serious Preventable Adverse Events. Other types of reportable events covered in the Memorandum, which are not subject to the Patient Safety Act, must continue to be reported according to existing procedures previously established by the Department. Those events include interruptions of physical plant or operations, communicable diseases, and alleged criminal activities.

Q: What is a “Serious Preventable Adverse Event”?

A: A “Serious Preventable Adverse Event” means a negative consequence of care that could have been anticipated and prepared against, but occurs because of an error or other system failure, and results in patient death, loss of body part, disability, or loss of bodily function lasting for more than seven days or is still present at the time of discharge.

Q: What are some examples of Serious Preventable Adverse Events?

A: Serious Preventable Adverse Events include, but are not limited to, certain care management related events such as medication errors, hemolytic reactions due to the administration of ABO-incompatible blood or blood products, maternal death/harm associated with labor or delivery in a low-risk pregnancy, hypoglycemia which occurs while the patient is in the hospital, and stage three or four pressure ulcers acquired after admission. Others are related to environmental events such as a patient death/harm from electric shock, burn, fall, or the use of restraints. Product or device related events, include death/harm resulting from contraindicated drugs/devices/biologics, misuse or malfunction of a device, or due to intravascular air embolism. Also reportable are certain surgery-related events and patient-protection related events, such as infant discharge to the wrong person, patient death/harm due to patient elopement, patient suicide or attempted suicide.

Q: How is a Serious Preventable Adverse Event reported?

A: The Department has prepared a form called “The Report of Serious Preventable Adverse Event in a New Jersey General Hospital”. The form must be completed and faxed to the Department within two (2) business days of the discovery of the Serious Preventable Adverse Event, but in no case later than five (5) days after the occurrence of the event. Reports are to be submitted to the Health Care Quality Assessment Program, not the Acute Care Survey Program, as in the past.

Q: Is the hospital required to follow-up on the report of a Serious Preventable Adverse Event? A: Yes. The hospital is required to submit a Root Cause Analysis on the reported event within 45 days following the initial report to the Department. The Root Cause Analysis is to be submitted on a form provided by the Department, and must include the facts of the event, causality, and corrective action plan.

Q: Who performs the Root Cause Analysis?

A: The Root Cause Analysis is to be performed by a multi-disciplinary team of the hospital or system to which the hospital belongs.

Q: Will the final rules be different than the interim mandatory patient safety reporting requirements?

A. Yes. Based upon our review of the Act and the Department’s draft of the rules, it appears that the final rules will be more expansive and will apply to the other health care facilities such as Special Hospitals, Rehabilitation Hospitals, Long Term Care Facilities, and Assisted Living Facilities. It is anticipated that the final rules will require each facility to establish a Patient Safety Plan and Patient Safety Committee that meet certain prescribed standards. The final rules will also implement a system for voluntary disclosure of less serious preventable adverse events and “near misses”. It is expected that the rules will be proposed in mid-year 2005. Nevertheless, the interim mandatory patient safety reporting requirements are effective February 1, 2005 for all New Jersey general hospitals.

For more information on the Patient Safety Act, or any other health care law related issues, please contact Brian M. Foley or any member of our Health Care Law Practice Group.