The following article appeared in the July 2011 issue of Connection, the e-newsletter from the AAAHC.
Q. On a survey, what exactly will the surveyor be looking for when checking compliance with standard 7.II.N on recalls? How many policies do we need?
Raymond Grundman, MSN, MPA, AAAHC Senior Director, External Relations & AAAHC Surveyor: In order to comply with standard 7.II.N, the organization should have a written policy and procedure to address the recall of items used in direct patient care to the extent that these items are currently used in the organization. The written policy should:
- Identify who in the organization is responsible for monitoring the recalls
- Describe how the responsible individual(s) will identify if the product is present in the organization
- Document the organization's response to the recall, including how the recall item(s) were removed from inventory and disposed of, and any patient notification, if indicated
Compliance with this standard does not require organizations to document the lot number of each and every medication administered to patients being treated in the organization's facility. However, this is a requirement and best practice for vaccines and implantable medical devices.
Maintaining an inventory list of all items used in patient care, sometimes referred to as an "Item Master File," is a desirable best practice. In addition, the organization should be advised to discuss the possibility of items being recalled with their distributors and suppliers and have a plan of action agreed upon in advance of any actual recalls. Vendors should be expected to maintain records of items purchased and supplied to the organization and to notify the organization of any recalls involving these specific items.
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Organizations do not need to rely exclusively on their distributors and suppliers for information on recalls. A common source for up-to-date information on the recall of drugs, vaccines, blood products, medical devices, medical equipment, and food products is the federal Food and Drug Administration. The FDA maintains a web site so that organizations can sign up to receive information on recalls, market withdrawals, and safety alerts on an immediate, daily, or weekly basis. To subscribe to the on-line notification program, click here.
To search for the most recently posted recalls, click here.
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