As speculation and uncertainty swirl around the final version of USP 797 and USP 800 — the standards for non-hazardous and hazardous drug compounding — due out in December 2019, hospital pharmacies are weighing the options and benefits of upgrading their pharmacy now versus waiting for the final standard adoption. The challenge of hitting this moving target may seem daunting, so where do you start? By asking the right questions.
Why should I start now instead of waiting until the regulation is finalized?
Regulatory compliance for USP 797 and USP 800 is a moving target that won’t come to a stop for nearly two years. However, once the standards are final, pharmacies must comply as of that date. Though immediate noncompliance may not be accompanied by specific citations, you will need to show a plan for any discrepancies found — and it could throw your accreditation with Medicare and Medicaid into question. Beginning the process now can provide flexibility in the allotted time frame to evaluate your options and make this required compliance fit your specific facility, processes, budget and constraints.
Does regulatory compliance mean a complete overhaul of my facility and procedures?
Not necessarily. From large and small to retail and in-patient, every hospital pharmacy has different procedures that will require a tailored solution. The processes for receiving, storing, unpacking, transferring, compounding, storing again and administering can be done in many ways. The design of these rooms and the type of equipment used are all dependent on your procedures — and your facility design should be customized around them.
One way we accomplish this tailored fit with our clients is by performing a gap analysis to understand how they operate now and compare that process, facility and equipment to the anticipated future standard. If gaps exist, rather than starting from scratch or overhauling rooms, we may be able to design solutions that change equipment, alter processes or shorten the time frame for storing drugs — all to minimize cost, complexity and downtime for the renovation.
For example, during a recent renovation project for Liberty Hospital in Liberty, Missouri, the pharmacy needed to add a new air handling unit to meet anticipated airflow requirements for the quantity and quality of airflow, as well as the pressurizations between rooms. Unfortunately, the pharmacy didn’t have space for the unit, so our team suggested relocating an adjacent breakroom and turning that space into a mechanical room for the equipment. This design change provided Liberty with the equipment it needed in a new area that will be easy to access and maintain moving forward while minimizing the disruption to the existing pharmacy operations.
How long will renovations take?
Depending on the scope of the renovations required, it is not uncommon for a traditional design-bid-build project delivery to take up to a year to complete just one pharmacy. To streamline this process and get pharmacies online faster, we recommend a design-build approach. Design-build for hospitals can compress that time frame by more than 50 percent by bringing everyone to the table to guide the design from day one, including the design and construction teams, USP certification personnel and equipment procurement professionals. This allows a clear path forward for the renovation without losing time on the front end waiting for equipment or on the back end if the final constructed product doesn’t meet certification requirements.
How many contracts and teams will I have to work with to complete the renovation?
Those numbers can balloon quickly if you’re not careful. By selecting a full-service firm that can offer a design-build, turnkey solution with planning, design, procurement, construction and certification all under one roof, you can narrow that potentially large number to one contract with one team.
Can I operate while renovations occur?
Yes, it’s possible. Another benefit of design-build construction is the ability to plan a phased schedule. Of course, a room under renovation cannot be used for drug compounding, but by using careful coordination and planning, you can still be allowed the space to conduct your critical work. For example, our project with Liberty Hospital required renovating the drug compounding rooms with their dedicated ventilation hoods. To keep the pharmacy running, Liberty is renting glove boxes for several weeks and installed them in an available room within the pharmacy until the compounding rooms are complete and functional.
How will I know if renovations will fit into my hospital’s budget?
The design-build delivery model allows your project team to establish guaranteed maximum pricing during schematic design. This approach asks and answers all questions about the renovation and certification requirements up front before completing a design, streamlining the process and making the budget more sound for your hospital’s fiscal plan.
What if I renovate now and the regulation changes?
Engraining flexibility into the design of your facility is key for any changes, as well as partnering with a firm that has intimate knowledge of the development of the USP standards. For example, we partner with Healthcare Solutions, whose personnel attend USP committee meetings. This hands-on experience with the standards provides the kind of detailed guidance necessary to select the right solution for you that also mitigates risk.
Get more details on how Liberty Hospital is planning its USP 797 and USP 800 compliance.