By James N. Phillips Jr.
I have written before about the sanctity of the medical supply chain (MSC). I want to share a piece on the devastating and deleterious effects of work-arounds on MSC integrity.
The supply system of a hospital is the gatekeeper of quality entering the facility from a very diverse collection of suppliers. Everything from gloves and gauze to stents and pacemakers are registered within the MSC.
The reason that the MSC is the gatekeeper is simple — the protection of patients from harm. The MSC stands on the watchtower looking out and in to see if the system is performing its role protecting patients from harm. Looking outward is simple, as notifications from FDA or the manufacturer send alerts to review. However, looking internally is an area of threat!
For example, a sterile surgical pack is received into the MSC; because it is a sterile pack, the only way to determine if there is a deficiency is to open it. But opening the pack outside the confines of a sterile area, such as the OR suite, renders the pack unusable for the purpose for which it was purchased. This is a destructive test and not the normal course of action; however, when opened in the proper environment and the sterile pack is non-conforming, this is a problem.
To compound the problem, the surgical suite personnel create work-arounds for things such as:
- Opening another pack with the hopes that the new pack will be conforming.
- Supplementing the pack with other items, to satisfy what was missing.
- Contacting the manufacturer or sales representative to get a replacement.
The proper response to any non-conforming product is to work with the facility’s product recall coordinator to identify the problem, describe the deficiency, and assess the impact.
This work-around has a cost in time spent to “fix” the problem and additional product used to “supplement” a deficient tray. If this is a hospital in a system of many hospitals, then the likelihood of a systemwide problem exists, thus compounding the problem.
So does the problem affect patient safety? Yes it does — by diminishing the reliability of the product purchased. For instance, what if the sterile surgical pack must have RFID or XR gauze, and the tray included non-XR gauze? Does the introduction of nonconforming material affect the integrity of the tray? What is the impact on the OR of such things? What is the impact on the MSC system? Is it unreasonable to expect suppliers of sterile surgical packs to provide what we asked and paid for?
Often the kneejerk reaction is to contact the manufacturer of the item, with a close second being the purchasing department; yet neither meets the needs of the facility. Only the MSC and its recall coordinator can aggregate the problem, assess the problem, and then work with the purchasing department to remedy the problem. Failing to collect and aggregate information related to nonconformation material diminishes the integrity of the MSC and potentially introduces a threat to patient safety.
Dr. James N. Phillips Jr., PMP, CFCM, FELLOW, is acquisition chief, Department of Veterans Affairs, National Center for Patient Safety, Ann Arbor, Mich. He may be reached at 734.930.5934.