The Compliance Binder is a pharmacy best practice that will really make your life easier. While not legally required, the compliance binder has everything you could ever be asked for by an inspector (with the exception of documents that are filed).
For the documents that are filed, it has a list of all of the documents and the locations of each one. This should, of course, also coincide with your filing cabinet labels that are taped on the front of each drawer and list the drawer number/letter and contents.
What are the advantages of a compliance binder? Here are a few:
1. Easier on your staff: You just have to show them one location for your records. No matter who comes in, "give them the compliance binder" can take care of everything.
2. Easier on you: In addition to making it easier to educate your staff on the locations of all pertinent records, the compliance binder allows you to more easily track your licenses, permits, policies, etc. You can quickly review everything to be sure you are on-track for your renewals and that you are not missing any records.
3. Easier on the inspector: The absolute best thing you can do when you are going through an inspection is to make it:
Very easy for them to find the records they need, and
Present the pharmacy as well-organized, clean, and completely in order.
There is a tendency for auditors as a whole to spend less time looking around a place that looks like there is less to find. Not only should you be the pharmacy where there is less to find, but you should give that impression as well.
How can you get started putting together a compliance binder?
First up - you need a list of records to put in it. Here's a template to help you with both your compliance binder and your filing cabinet records:
Now, some tips on compiling the compliance binder:
Start with at least a 2-3" Binder
It's going to take a big binder to fit everything. After all, this should include licenses, certificates, policies and procedures, required documentation for third parties, and more.
Be sure to add records required by state law too
For example, in Florida where I practice, the Board of Pharmacy requires quarterly Continuous Quality Improvement meetings; in fact, they're required in many states. The meetings notes are a common item inspectors ask for, so I have a tab dedicated just for my CQI notes. Because of so much variation between states the template does NOT include these types of records.
Update it regularly
An important note is that you will want to be sure to update your binder regularly as records expire or a more current record is produced (ex. licenses, the regular controlled substances inventory, etc.).
Use it for third-party compliance too
For example, DMEPOS accreditation requires proof of policies and procedures, an organizational chart, etc. A Board of Pharmacy inspector would never ask for these things but the Medicare inspector might. The compliance binder can also help with third party on-site inspections.
Keywords: record keeping