Q. What area of accreditation takes the most amount of time and should be started early?
A. The amount of time it takes to complete all segments of accreditation preparation will differ between providers. But one problem area is a provider’s ability to track HME items and medical supplies with lot numbers or serial numbers.
The goal of this standard is for the provider to find equipment and supplies that they have furnished to their patients in the event of a manufacturer or Food and Drug Administration (FDA) recall. This can only be accomplished if the provider first identifies these products and begins logging all items with lot numbers, manufacturer’s serial numbers or their company’s internal inventory control numbers. Examples of items with lot numbers could include diabetic test strips, oxygen cylinders, urological items and enteral food products.
If you have a limited number of patients using a specific item, the “shotgun” approach might be acceptable to the surveyor. The “shotgun” approach entails auditing patient files to find an item with a recalled lot number or serial number. This will work in instances where you have a master list of patients using a specific item and shouldn’t include auditing all patient files to find a recalled item. HME items are prioritized by the FDA into categories. Your policy and procedure manual should list items within these categories.
The only reasonable way you can comply with this standard is to have this information documented during delivery and enter these identification numbers into a workable process for possible future recall. If you do not currently log these numbers, it may take you a long period of time to audit patient files or contact your patients directly and identify the items that they have in their possession. If the provider waits until the end, they may find that they do not have enough time to complete this task and are deficient with this standard.