Similar to the often used phrase “be sure this is included in your policy and procedures”, auditors get the same satisfaction by telling folks that “this needs to be included as part of your routine self-auditing”. It is easy to assume clean sites don’t need much attention in this area because of their very nature – they are a clean site (340B only with physical 340B inventory) and all covered outpatient drugs within them are considered eligible for 340B. While this set-up can seem much more straight forward than managing a mixed-use location, its simplicity should not be construed as a ‘set it and forget it’ type situation; proper oversight and auditing practices are still essential to ensuring a compliant 340B Program, even in a clean site. I would like to share a few considerations to set your clean site up for success.

The first consideration is to make sure you are treating your clean site like any other area of your program where medications are administered to patients. That means you need to make sure you have proper documentation supporting the administration of the medication. A monthly review of clean site transactions is critical to make sure documentation is readily available and diversion risk is mitigated. These records should include a documented order, documented administration, and documentation supporting the medication was administered at an eligible location per your Medicare Cost Report or scope of grant. This first step is important because without these records, we can’t pass GO. The expectation of auditable records goes beyond a simple “administered on 1/1/21 at 14:40 in the Raney Clinic and verbal order by Dr. Nate”. You need to be able to produce utilization data (e.g., what was administered or wasted/expired) and purchase data. Anytime a 340B product moves, you should be able to account for its final destination in the utilization data. This process isn’t the same for everyone. For example, some sites may rely on patient-specific medication administration records for utilization data, while others may rely on detailed inventory records, or even accumulation records so long as they are used solely to track charged medications and not for purchasing. As the old adage goes, “When you have seen one 340B Program, you have seen only one 340B Program.” No two programs are the same and as long as you are able to produce comprehensive auditable records, your way is the right way.

Moving right along into another self-audit consideration, and arguably one that isn’t done as often as it should, is an inventory reconciliation audit of your clean site. Reviewing utilization and purchase data to ensure what is on the shelf is what is expected by taking total purchases minus other variances in inventory (administrations, waste, expired, etc.) and reviewing inventory on hand. Basically, such a review mitigates the risk of diversion. This is why it is important to ALWAYS document medication waste and expired medications to ensure you can track and trace all 340B physical inventory. Regular self-auditing (e.g., quarterly) of a reasonable number of individual medication utilization records (e.g., 5 drugs) should be completed for internal use to ensure that clean site 340B purchases are consistent with utilization in light of current inventory on hand. The completion of these audits should be documented for internal use, issue identification, and reconciliation, while a blank audit log table showing the headers/elements reviewed can be provided during an external audit (if warranted). An example of the process is demonstrated in the sample audit log table below.

Moral of the story? Get as excited as auditors do when self-auditing is mentioned. It will not only set your covered entity up for success but will also make you good stewards of the 340B Program and, if you are like me, come with the added bonus of allowing you to sleep better knowing your program is as compliant as you can make it!