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Closing the gap: Interim steps toward NAPRA compliance for Canadian hospital pharmacies

April 08, 2022

By Steve Black

Don’t wait for construction to make changes to comply with the new standards. Focus on short-term solutions regarding your process—here are 6 steps.

If you own or operate a hospital pharmacy in Canada, you’re likely aware of the standards published by the National Association of Pharmacy Regulatory Authorities (NAPRA). In 2016, NAPRA unveiled the Model Standards for Compounding Non-Hazardous and Hazardous Sterile Preparations. Since then, Canadian provinces have adopted these standards. They’ve put compliance deadlines in place. And the consequences for noncompliance could include shutting down your pharmacy.

Many hospitals are struggling through protracted capital redevelopment processes within their organizations and jurisdictions. They’re trying to get projects off the ground so they can upgrade their pharmacy facilities—and ensure those facilities can continue to operate. 

Incremental steps toward closing the “compliance” gap, often at little or no capital cost, can go a long way to improving outcomes in the short-term.

Time is passing. But there’s a lot of work that hospital pharmacies can do now—without waiting for full renovations—to move sterile compounding practice towards NAPRA compliance and improve desired outcomes. Examples include:

  • Protection of the medication (e.g., contamination, accuracy, error)
  • Protection of the personnel (e.g., exposure to hazardous substances)

NAPRA compliance includes hard functional parameters related to air quality. It also has softer process aspects, such as the storage of supplies and gowning/garbing. These “softer” processes can have a more significant impact on quality and desired outcomes. You can take straightforward steps—right now—to identify and implement process improvement in anticipation of a capital redevelopment project.

So, you don’t need to take an all-or-nothing mindset. Incremental changes, focused on process, can go a long way toward NAPRA compliance. Don’t just sit and wait for capital upgrades. Before we explore some valuable short-term solutions for hospital pharmacies, let’s dive into a bit of background.

NAPRA compliance: Air quality and process improvement

What’s the purpose of renovating to meet NAPRA standards? Renos to meet these standards will be designed to improve compounding outcomes in two basic ways:

  1. Creating a passive “state of control” through high levels of air cleanliness and reducing and preventing particulate generation.
  2. Shaping and supporting the processes and activities taking place within the pharmacy.

How are proper processes and best practices supported by renovations? This might include:

  • Reducing the opportunity for contamination, inaccuracy, and error
  • Supporting comfort and safety of compounding personnel
  • Minimizing activity detrimental to maintaining air quality (e.g., turbulence and disruptive airflows near the clean air device)

This support may be direct (e.g., creating a logical and intuitive workflow, selecting building materials that support effective cleaning and disinfection). It can also be indirect (e.g., reducing ambient stress like heat/noise/ergonomics, or reducing distraction and diverted attention of compounding personnel).

I believe we need to put more emphasis on the process. You can act now to fix process before you even get a construction project in place. Perhaps you tweak processes to anticipate new construction—or maybe your changes have nothing to do with construction. Do it anyway. Maybe you relocate a piece of equipment. Perhaps you change the path your personnel walk on the floor. I’ll elaborate below. 

There’s no excuse not to explore and develop short-term/stop gap process improvements as part of an ongoing quality improvement program.

Time for a reality check

Let’s consider an important fact: Process and the actions of compounding personnel are the top causes of clinically significant microbial contamination. Not air quality.

As the CSHP Compounding Guidelines for Pharmacies mentions in the 2014 edition, “It is commonly understood that most contamination is related to the actions of compounding personnel compared to other sources.”

So, you can achieve the most significant impact on quality through improving process. These improvements aren’t contingent on capital redevelopment.

Let’s not put all our eggs into the capital redevelopment basket. You won’t be able to achieve your air quality improvements today—whether it’s the HEPA filtration, or room pressurization, or something else—but that’s OK. There’s a lot you can do to fix process. And those changes might include minor tweaking of the physical environment—or not changing the physical environment at all.

Interim opportunities for improvement

Let’s recap. I’ll focus on the bad news first.

The bad news: The capital redevelopment process takes a long time. Creating those physical changes at your facility can be slow. Business cases, competing for limited resources, internal/organizational approvals, feasibility studies, ministry approvals, consultant selection, planning, yet more planning, design, construction documentation … it’s a lot. And it means that it’s going to take a while to realize the mandated NAPRA compliance upgrades at your facility.

The good news: Current wisdom says the most significant impact of a capital redevelopment project will be on process improvement. Much of this improvement can be accommodated and/or anticipated in the current workspace before the renovations. You can do something now. 

Tour as many facilities as possible and visit the good, the bad, and the ugly.

So, why wait? There’s no excuse not to explore and develop short-term/stop-gap process improvements as part of an ongoing quality-improvement program. To that end, I’d recommend the following steps:

  • Know the standards/guidelines
  • Know your existing condition
  • Start process mapping
  • Do a gap analysis
  • Define opportunities and prioritize
  • Execute/follow through/follow up

Let’s explore each of these six steps below.

Step 1: Know the current standards

The first step? Educate yourself on the standards. Learn about their intricacies. And take these two actions: 

Appoint a champion: If I managed a pharmacy department, I’d tap the newest and youngest pharmacist or pharmacy technician to be the “owner” of current and emerging standards and guidelines. I’d also give them authority for final interpretation. This knowledge isn’t contingent on practical experience. That same practical experience can be an obstacle to correct application of the standards.

Connect with peer facilities: Tour as many facilities as possible and visit the good, the bad, and the ugly. Using a critical eye, try to understand their interpretation and application of the standards.

Step 2: Know your existing condition

Document and learn as much as you can about your existing facility. Talk with facilities and maintenance staff. What building services are located above your cleanroom (e.g., are you dealing with plumbing leaks)? When was the facility constructed, and what standards were in place at that time? Where is the building intake for the air supplied to your cleanroom located? What types of activities are taking place around the air intake that could impact air quality?

Step 3: Start process mapping

Now it’s time to map your process. There are two parts to this: What are we doing now? And what should we be doing, ideally?

I think of process mapping as the development of discrete activities to account for all the steps needed, and the resources involved with completing a given activity properly and effectively. Where are the checkpoints that signal something isn’t going right? Where is there latent deviance or “creative compliance” that could undermine positive results?

Current wisdom says the most significant impact of a capital redevelopment project will be on process improvement.

Step 4: Do a gap analysis

It’s surprisingly difficult to do gap analysis well, as you compare your current performance with your desired performance. Ideally, gap analysis should be painfully comprehensive, outcomes-focused, and articulated in terms of flows identified in process mapping. Those flows include the flow of people, product and supplies, equipment, waste, information, etc.

Step 5: Define opportunities and prioritize

How can you find the biggest bang for your buck? What can you do—today—to close the gap toward where you intend to be after a NAPRA compliance upgrades project?

Looking at the range of process gaps, it should be a straightforward approach to identify opportunities to improve activity and/or to tweak the physical environment to enable workflow adjustments. Maybe you:

  • Install a full-length mirror to support gowning/garbing
  • Organize workflow to reduce number of times your cleanroom door is opened
  • Remove the sink from the cleanroom
  • Consider printing labels outside the controlled work area, or …
  • … decide not to compound

As an example, let’s look at the disruptive airflow around a clean bench or biological safety cabinet (BSC). What can you tweak today? Here’s the rule of thumb: As cross drafts and disruptive airflows approach the face velocity of the clean bench or BSC—at 80 to 100 feet per minute—bad things happen. You don’t have to be walking very quickly—1.5 feet per second—to create air displacement in front of and around you at a rate detrimental to the effectiveness of these devices.

Is there a way to redirect traffic and/or reposition the clean bench/BSC toward supporting better quality outcomes?

Step 6: Execute/follow through/follow up

It’s so important that change be informed by purpose. You can succeed in process improvement by constantly emphasizing why the change is being made, repeatedly educating staff and users, and revisiting the change in 6 to 12 months to confirm the change stuck and the purposes—aka the desired outcomes—are being achieved.

Incremental steps go a long way

NAPRA compliance upgrades are not ends in themselves. They certainly don’t need to be applied in an all-or-nothing mindset. Incremental steps toward closing the “compliance” gap, often at little or no capital cost, can go a long way to improving outcomes in the short term. Do something—and do it now.

  • Steve Black

    Steve has played a key role in the programming, planning, and designing of healthcare facilities across Canada and the world. He has subject matter expertise in infection prevention and control and is experienced in facilitating Lean planning.

    Contact Steve
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