MCN Healthcare: Policy Management and Compliance Tools

The Commission on Accreditation of Rehabilitation Facilities (CARF) 2013 accreditation manual for Behavioral Health defines a sentinel event as:

"an unexpected occurrence that results in death or serious physical or psychological injury or serious physical or  physiological injury or the risk thereof.  Serious injury specifically includes loss of limb or function.  The phrase "or the risk thereof" includes any process variation for which a reoccurrence would carry a significant chance of a serious adverse outcome."

Behavioral Health organizations accredited by CARF are expected to have written policies and procedures in place to respond to critical incidents, including sentinel events.  Policies should address:

• Prevention
• Reporting
• Remedial Action

Accredited organizations are expected to provide CARF with information about the event within 30 days of its occurrence.

CARF standards allow organizations to develop policies and procedures that are specific to the needs and characteristics of their own organizations.  Included with today's StayAlert Notice is an example policy and procedure that address responding to sentinel events in the Behavioral Healthcare setting.  Use this tool as a starting point to customize and implement your own organization-specific sentinel event response policy.

The U.S. Food and Drug Administration (FDA) is working closely with the Centers for Disease Control and Prevention and Tennessee Board of Pharmacy to investigate reports of seven adverse events associated with steroid injections compounded by Main Street Family Pharmacy, LLC (Main Street) of Newbern, Tenn.

Out of an abundance of caution, the FDA recommends that health care providers not administer any products labeled as sterile from Main Street and quarantine them until further guidance is provided.

The reports of adverse events are all from patients who received preservative free methylprednisolone acetate (80 mg/mL) by injection. To date, the FDA has received seven reports. Clinical information about these patients is pending; at least one of these infections appears to be fungal in nature.
 
An investigation into the exact source of these adverse events is still ongoing, but these cases are associated with a potentially contaminated medication. As part of the ongoing investigation, the FDA will continue to work closely with the CDC and state authorities to thoroughly review the sterile practices at Main Street.

The US Food and Drug Administration (FDA) is informing health care providers that Cook Medical has received a small number of complaints that the delivery system of the Zilver PTX Drug-Eluting Peripheral Stent had separated at the tip of the inner catheter. Potential adverse events that may occur in cases where the inner deliver catheter breakage occurs include possible surgery to remove the catheter tip, vascular occlusion due to an unretrieved catheter tip, thrombosis, amputation, possible cardiac arrest, and death. This recall includes all sizes, diameters and lot numbers prior to April 16, 2013.

The Zilver PTX Drug-Eluting Peripheral Stent is a self-expanding, small metal, mesh tube with the outer surface coated with the drug Paclitaxel that is implanted in an artery of the thigh. The Paclitaxel coating helps prevents the artery from narrowing again. The Zilver PTX Drug-Eluting Peripheral Stent acts as a scaffold to hold open a narrowed artery caused by Peripheral Artery Disease in the legs and to improve blood flow.

The Zilver PTX Drug-Eluting Peripheral Stent was manufactured from Dec. 1, 2012 through April 16, 2013 and distributed from Dec. 13, 2012 through April 16, 2013.

Cook Medical sent an Urgent Medical Device Recall letter dated April 24, 2013 to all affect customers. The letter identified the affected products, description of the problem, and actions to be taken. The letter instructed customers to stop use, quarantine, and return all affected products for credit to Cook Medical.

Read the MedWatch safety alert including links to the Recall Notice and Press Release, at the link below.