Did you know that at least one hazardous drug policy or process made the Top Five USP <800> requirements being reviewed by State Boards of Pharmacy, Accreditors, and Centers for Medicare and Medicaid1?
- Hazardous Standard Operating Procedures (SOPs) made the State Boards of Pharmacy top five.
- Garbing procedures and product wiping/disinfection procedures were two of the top five with accreditors.
- Documentation was number one for the Centers for Medicare and Medicaid while nursing processes also made the top five.
This tells us that the written policies are just as important to USP <800> compliance and healthcare worker safety as the follow-through.
With this in mind, our final blog in the series expanding on our most popular blog in 2021 - “From Our Customers: The Top 8 Questions To Expect In Joint Commission Inspections” gets down to what the Joint Commission and other accrediting institutions will be looking for when it comes to policies and procedures, a vital piece of the USP <800> compliance process.
Policies and procedures are nothing new to a healthcare system but what has been unusual with USP <800> is that the Pharmacy is now generally responsible for creating, documenting, communicating and also ensuring SOPs are followed. The Pharmacy now must ensure USP <800> compliance, which means that the Pharmacy is also responsible for protecting all health system employees from exposure to hazardous drugs. It really is remarkable that this heavy lift is placed on the shoulders of the Pharmacy director and staff. We’re here to help!
Here’s a handy list of policies you must put in place and follow:
- Is your list of HDs and their dosage forms available and reviewed every 12 months?
- What is your policy around Assessments of Risk? While USP <800> does not officially require each hazardous drug to have an AoR, clients say that inspectors expect some AoR language for each drug. Is your healthcare system’s AoR language established? Do you review AoRs every 12 months?
- Is your Designated Person in place and are they qualified and trained? Do you have a succession plan if - or more likely when - your Designated Person leaves?
- As required by the USP <800> Hazard Communications policy, do all healthcare workers who come into contact with hazardous drugs understand the risks? Is this documented?
- What is your policy around Medical Surveillance for both routine exposure to hazardous drugs and also for when acute exposure occurs?
- Personnel training policies cover the gamut including compounding; proper use of PPE; overview of SOPs available to employees; proper use of equipment and devices; and spill management. This is just a start.
- Along with personnel training comes the policies around the equipment and facilities such as spill management; receiving and unpacking; storage; nonsterile and sterile compounding; proper use of PPE? Also, is equipment such as C-PEC and C-SEC certified, and is there a plan for an uninterrupted power source for the negative pressure ventilation system?
- Personnel is also responsible for the understanding of fundamental exposure precautions; ways to minimize exposure to employees and contamination of the work and patient care environment; and the documentation of training and competence. Do you have these policies in place and are they being followed?
- Do you have policies for signs alerting employees to Hazardous Drugs areas as well as restricted areas?
This just touches the surface but gives you an overview of policies expected by inspectors from any of the accreditors. Check out our blog for more details on Assessment of Risk, Designated Person requirements and responsibilities, Medical surveillance, and key components of an Effective Hazardous Drug Communication Plan - Part 1 and Part 2.
We’ve been compiling the Top USP <800> Questions for 2022 and will be sharing that with you soon!
1Pharmacy Purchasing and Products Magazine, USP <800> Compliance Updates, 7-14-2022