Infection Prevention

& Control Within the

Physical Environment
4 High Risk Areas Healthcare Facility Managers Need to Know
Introduction

Hospital infection control isn’t solely a responsibility for doctors and

nurses. With the rising concerns surrounding healthcare-associated
infections (HAIs), reducing infections in the physical environment has
become an increasingly more important — and regulated — priority.
Due to high-publicity outbreaks and increased scrutiny from regulatory
agencies, healthcare facility managers are now joining infection control
practitioners on the front lines of patient outcome improvement.

And it doesn’t take much digging to understand just how devastating contracting an infection from their
physical environment can be for a vulnerable or immunocompromised patient. Take Aspergillus infections,
for example. Hospital construction or renovations account for half of all healthcare-associated Aspergillus
outbreaks, with an estimated 5,000 deaths due to construction-related infections occurring each year. In fact,
it’s estimated that transplant patients who suffer from an Aspergillus infection face a mortality rate between 74
to 92 percent.

The risks don’t stop with just one type of fungi, like Aspergillus. Hospital-acquired Legionnaires’ disease
(caused by Legionella bacteria) has a higher than 40 percent mortality rate — which is approximately twice as
deadly as the rate for community-acquired Legionnaires’ disease. While this increased rate is easily explained
by the vulnerable condition of hospital patients, it only further underscores the importance for vigilant
infection prevention.

The most prominent and highly publicized occurrence of infection in recent years caused by failing to maintain
the physical environment is the New England Compounding Center (NECC) fungal meningitis outbreak of 2012.
With more than 800 cases of illness and more than 65 deaths across 19 states, this outbreak was nothing short
of precedent setting — but more on that in Chapter 4.

The consequences of these risks have shed new light on the steps facility managers and infection control
practitioners can take to minimize instances of physical environment-related infections. While there are
concrete processes and actions that need to be put in place, let’s first discuss their responsibilities in
looser terms.

Infection Prevention & Control Within the Physical Environment: 4 High Risk Areas Healthcare Facility Managers Need to Know 2
First and foremost is obtaining a clear and thorough understanding of the infection risks and the role the
physical environment can play. Once these risks are assessed and a mitigation plan is put into place, facility
managers need to help foster communication between departments and individuals responsible for enacting
these processes. Without communication and clear designation of roles and responsibilities, risks cannot be
properly managed.

Next, while patient safety is a top priority of healthcare facilities, maintaining compliance with various
regulatory and accreditation agencies is also front of mind with many facility directors. Luckily, focusing on one
will certainly help with the other.

Now, let’s talk about the specific risks that facility managers need to not only be aware of, but actively helping
to prevent. We’ve identified four critical risk areas that represent the most common instances of infection, pose
the highest risk to patients, and have recently received increased attention from regulatory agencies. These
four areas are:

• Improper pressurization and ventilation

• Construction site isolation

• Legionella growth

• Sterile drug compounding contamination

This guide will delve into why each of these risk areas require awareness, as well as discuss compliance
strategies and what facility managers can do to improve infection prevention and control in the physical
environment of their healthcare facility.

Infection Prevention & Control Within the Physical Environment: 4 High Risk Areas Healthcare Facility Managers Need to Know 3
CHAPTER ONE:

Improper Pressurization and Ventilation

Healthcare-acquired infections aren’t just dangerous to patients — they

can also be very costly for the facilities in question. Since procedures
and processes that are high risk for infection are performed in places like
operating rooms and central processing, ensuring proper pressurization
and ventilation to avoid infection is a matter of life and death.

The current version of the American Society of Heating Refrigerating and Air-Conditioning Engineers (ASHRAE)
standard 170, which has been adopted by the Facility Guidelines Institute (FGI), establishes the minimum
requirements for new construction. Older buildings, however, are subject to the code that was in effect at the
time of construction.

And while becoming compliant is an ongoing effort and significant investment for healthcare facilities to make,
failing to follow FGI guidelines for pressurization or making the fixes after a Joint Commission survey (when
only allowed 60 days to do so), could leave your hospital vulnerable to even costlier outbreaks. Yet, despite the
importance of proper pressurization and ventilation, statistics from The Joint Commission revealed that more
than half of hospitals weren’t compliant with ventilation system requirements.

Depending on the purpose of the room and the condition of the patient, airflow needs to be directed either
into or out of the room. For example, if a patient is immunocompromised, the airflow needs to be directed out
of the room to prevent infection from spreading to the patient during their weakened state. The same goes
for rooms where invasive procedures are occurring, like operating rooms, which also require 20 air changes
per hour under the current version of the code. (However, this number is less for older construction, so it’s
important to note the year of construction and manage appropriately.)

On the other hand, when the patient is the actual source of infection and needs to be in an isolation room, the
airflow needs to be directed into the room to protect others and keep the infection from spreading. Another
reason a space will need negative pressurization is to control odors, such as soiled utility rooms. Airborne
isolation rooms require 12 air changes per hour.

Infection Prevention & Control Within the Physical Environment: 4 High Risk Areas Healthcare Facility Managers Need to Know 4
Think of it this way: positive pressurization is for the protection of the patient, while negative pressurization is
for the protection of the caregivers or odor control. The goal is to either keep infection causing aerosols out or
keep them in.

How to Ensure Your Pressurization and Ventilation Process is Compliant

Aside from the safety of patients, caregivers and hospital patrons, ensuring proper pressurization is also a
significant compliance concern. The Joint Commission has made pressurization an increasingly important area
of focus in recent years. An often made and incorrectly held assumption is that a hospital’s existing mechanical
system is configured for proper ventilation and pressurization, simply because it was at the time of design.
Unfortunately, even if the initial design met the standard, that doesn’t mean it remains in compliance. That’s
why having an effective ongoing compliance monitoring strategy is so important.

So, what can facility managers do to keep patients and hospital workers safe from airborne infections spread by
improper ventilation and pressurization? Here are four key aspects to a strong compliance strategy:

Updated inventory of pressure dependent spaces

The areas of your healthcare facility requiring specialized ventilation are likely to change over time due to
changes in space usage. Or, guidelines will change over time, requiring different guidelines for different areas.
For instance, the regulations for pressurization in endoscopy rooms have changed in each of the last three
iterations of the FGI guidelines — which means your processes need to change, too. By keeping an updated
inventory, you can ensure that no space ever gets overlooked during your testing or monitoring processes. It’s
also good practice to have a regular schedule for assessing and updating your inventory.

Routine monitoring and inspections

High-risk areas, like your hospital’s operating rooms, need to have pressure validated routinely. While less risky
spaces — like a soiled utility room — can be tested on a less frequent basis (like quarterly or semi-annually),
it’s still best to have routine monitoring systems in place for quick check-ups. Whether you use a ball in tube
system, digital manometer or wireless pressure sensor technology, you’ll need some way for staff to complete
routine checks.

Staff education

Which brings us to the third key aspect to a strong compliance strategy: educating your staff. Every
person involved in monitoring and ensuring proper pressurization of sensitive areas needs to have a clear
understanding of the reasons and risks behind the procedures. Make sure to designate responsibilities clearly
and communicate effectively.

Infection Prevention & Control Within the Physical Environment: 4 High Risk Areas Healthcare Facility Managers Need to Know 5
It’s also important not to overlook the smaller details. For instance, a door remaining closed is essential to
maintaining the necessary negative pressurization. Your staff should understand the importance and severity
of this instruction to prevent careless mistakes.

Action plan for non-compliant pressure dependent spaces

Once you finalize a comprehensive inventory of pressure dependent spaces, it is nearly inevitable that
deficiencies will exist. It is, therefore, critical to develop an action plan for non-compliant pressure dependent
spaces. Most actions involve making the room tighter (e.g., filling penetrations, door sweeps) or balancing
rooms (e.g., changing the offsets between supply and exhaust flow rates) to make most rooms compliant. That
said, some non-compliant rooms will require (potentially expensive) upgrades to HVAC and controls systems,
so it’s important that you communicate the infection control and compliance concerns for non-compliant
pressure dependent spaces. With this approach, you can make the business case for HVAC and controls system
upgrades, where needed.

Complex environments, aging infrastructure, changing codes, and balancing one area only to unbalance
another are all challenges to maintaining proper pressurization. For these reasons, having a clearly
established inventory and monitoring plan is essential.

Infection Prevention & Control Within the Physical Environment: 4 High Risk Areas Healthcare Facility Managers Need to Know 6
CHAPTER TWO:

Healthcare Construction Site Contamination

Construction is an inevitability of healthcare facilities. Improvements

and updates need to be made and construction can be a complex —
and potentially dangerous — process within hospitals. Any size
construction project can risk exposing patients to dust and mold spores,
noise, vibrations, odors or chemicals.

Luckily, by planning ahead and taking necessary precautions, you can protect vulnerable patients and still allow
healthcare construction projects to move forward. Isolating large-scale projects and utilizing a relative negative
pressure for construction sites can reduce many of the risks. However, where hospitals tend to make mistakes
is by failing to take into consideration the specific needs of the adjacent areas, which could potentially have
unique complexities.

To help minimize the dangers of hospital contamination, the Joint Commission requires hospitals to perform an
Infection Control Risk Assessment (ICRA) and a Preconstruction Risk Assessment (PCRA). While ICRA identifies
the risks of patient exposure and the impact to adjacent areas, PCRA assesses fire safety, air quality, and noise
impact, etc.

However, despite the best intentions of these risk assessments, deficiencies in the process still happen. Let’s
examine the types of problems that occur and how facility managers can handle them.

Common Problems to Ensuring Healthcare Construction Site Infection Safety

1. COMMUNICATION BREAKDOWNS

Successful compliance requires cooperation from a diverse and multidisciplinary group. In addition to facility
managers and infection control practitioners, construction sites also have engineers, construction crews, and
environmental health and safety officials. Each person involved has a different job and different priorities, so
keeping everyone on track with the importance of infection prevention can be a difficult task.

Infection Prevention & Control Within the Physical Environment: 4 High Risk Areas Healthcare Facility Managers Need to Know 7
2. FAILURE TO CONSIDER ADJACENCIES

As mentioned above, this is a common mistake hospitals make. The pressurization of areas adjacent to, above,
and below a construction site should be considered carefully to ensure monitoring goes beyond the corridor
and extends to all potentially affected areas.

3. LACK OF MONITORING

It’s easy to get caught up in projects and fall out of a routine monitoring schedule. However, just like general
pressurization is important to track and review, construction site pressurization also requires routine checks to
stay compliant.

What Facility Managers Can Do to Reduce Healthcare Construction Infection Risks

Now that the key problems have been identified, let’s go over the behaviors and practices facility managers can
implement to avoid or solve them.

• Checklists:
Compile a standardized checklist ranked by risk and make sure every member of your team has the
information they need to address each potential risk before a problem occurs.

• Contractor “report cards”:

Help your contractor know exactly what to expect before stepping foot in your hospital. If at all
possible, hire a construction crew with experience working in sensitive areas. Setting expectations up
front and following up with periodic “report cards” will help keep everyone on the same page.

• Holding meetings, acquiring permits, documenting:

Be vigilant about communicating with your team and keep documentation of all necessary paperwork
and processes.

• Routine audits:
Plan to do at least weekly audits of the construction site to ensure ICRA standards are met and
additional problems haven’t occurred.

• Automated monitoring:
With 24/7 automated monitoring, there are multiple control measures put into place to contain and
minimize contaminants. By providing advanced warning of a problem, an automated monitoring
system can help your team respond and fix an issue before it negatively impacts patients, while also
avoiding construction shut downs.

Having a plan in place — and ensuring that all parties involved are on board with that plan — will help keep
your facility safe and your patients unharmed.

Infection Prevention & Control Within the Physical Environment: 4 High Risk Areas Healthcare Facility Managers Need to Know 8
CHAPTER THREE:

Legionella Growth

Between 2011 and 2014, 29 patients at the Veterans Administration

hospital in Pittsburgh, PA were diagnosed with Legionnaires’ disease,
with confirmation of at least five of the cases acquired at the hospital.
The Veterans Affairs Office of Inspector General later tied the deadly
outbreak to deficiencies in the water system.

Records show that not only did the hospital water not contain enough disinfectant to prevent Legionella bacteria
from spreading, but the system was also not maintained properly, despite evidence that the hospital was well
aware of the problem.

As if the deadly consequences of Legionella growth weren’t motivation enough, Centers for Medicare &
Medicaid Services (CMS) recently announced that, effective immediately, Medicare-certified healthcare facilities
are expected to have water management policies and procedures to reduce the risk of Legionella and other
opportunistic pathogens in building water systems. This means that The Joint Commission will also scrutinize
waterborne pathogens and water management programs during accreditation surveys to ensure they follow
CMS requirements. Facilities that cannot demonstrate measures to minimize the risk of Legionnaires’ disease
are at risk of citation for non-compliance.

Luckily, with the right Legionnaires’ disease prevention techniques, the spread of this harmful bacteria is wholly
preventable and the risks can be easily managed.

How Does Legionella Bacteria Occur and Why is it Dangerous?

Legionella bacteria is ubiquitous, and growth is common in utility and potable water systems — like cooling
towers, condenser water systems, tanks, showers, faucets and air conditioning units. It grows in stagnant
water that is between 68 and 124 degrees F. This can become a problem in healthcare facilities when water
systems experience underuse; for example, a shower in the ICU may not receive enough use to ward off
Legionella growth.

Infection Prevention & Control Within the Physical Environment: 4 High Risk Areas Healthcare Facility Managers Need to Know 9
If the growth of Legionella bacteria goes undetected, hospital patients could become susceptible to breathing in
airborne mist from water droplets containing the bacteria, which can lead to the development of Legionnaires’
disease. As mentioned in the introduction, this form of pneumonia is generally deadly in about 10 to 20 percent
of cases when it is acquired out in the community. However, this number jumps to 40 percent for hospital
patients who may already be immunocompromised.

What Can Facility Managers Do to Comply With Legionella Regulations?

ASHRAE 188, a national consensus standard for Legionella risk assessment and risk mitigation was finalized in
2015 (enforceable by CMS and The Joint Commission in 2017) and establishes best practice recommendations
that building owners and facility managers must adhere to in order to remain compliant. Here are the four key
steps healthcare facility managers need to take in order to protect vulnerable patients and remain compliant
with ASHRAE 188.

• Conduct a building-wide survey and risk assessment.

You won’t know how to fully protect the inhabitants of your
... with the right Legionnaires’
hospital from the potential growth and spread of Legionella
bacteria unless you are knowledgeable about your water systems
disease prevention techniques,

and of the areas in which growth could occur. A building-wide the spread of this harmful
survey can help identify these areas so you’ll know sources that bacteria is wholly preventable
result in amplification of Legionella and the processes your water and the risks can be easily
management team will need to put into place. You’ll need to managed.
look for dead legs in your plumbing — which are areas where
water easily collects, but becomes stagnant with low usage —
as well as water features and cooling towers. You will want to
include your water treatment vendors in the process since pH,
residual disinfectant levels, and temperature are critical factors to
understanding the risk assessment.

• Build a knowledgeable water management team.

Once you’ve conducted your building-wide survey, it’s time to bring together the members of your
water management team. While the specific members may vary depending on your unique facility,
some common members may include: the director of engineering, the director of infection control,
the medical direct of epidemiology, a senior-level support services director, a member from public
affairs, a representative from critical labs, and the facility manager. Within your water management
team, you’ll need to specifically assign clear rules and responsibilities. Every member will need to work
together to ensure the risk of Legionella growth is fully mitigated, so clear roles and responsibilities and
communication is a must.

Infection Prevention & Control Within the Physical Environment: 4 High Risk Areas Healthcare Facility Managers Need to Know 10
 • Develop an action plan to address the risks identified during the building wide survey:
After you conduct a building-wide survey and risk assessment, there are bound to be various risks
from dead legs, to tweaks needed to your preventative maintenance program. Once you identify those
risks, you must put an action plan in place to mitigate the risks, then measure the effectiveness of
the change.

• Establish a consistent maintenance program.

Your maintenance program is made up of the regular tasks required to keep Legionella from growing.
You’ll need to determine a cleaning and maintenance schedule for your cooling towers and pH and
residual disinfectant levels, as well as establish a temperature monitoring protocol. Then, you can
determine if you will conduct monitoring for Legionella bacteria.

With all of these processes, it’s essential to have complete buy-in from each of the staff members involved
— from the directors on your water management team, all the way down to the cleaning crew responsible
for the flushing program. Make sure you’re clear with everyone about why following Legionella management
procedures is important to the health and safety of hospital patients.

Infection Prevention & Control Within the Physical Environment: 4 High Risk Areas Healthcare Facility Managers Need to Know 11
CHAPTER FOUR:

Sterile Drug Compounding Contamination

Our final risk area for facility-related infection prevention is the

contamination of sterile drug compounds. Like Legionnaires’ disease,
outbreaks related to this risk have also recently made headlines —
leading to a changing landscape for pharmacy compliance.

The most widely publicized contamination outbreak was traced back to the New England Compounding Center
in 2012. As mentioned previously, this outbreak led to more than 800 cases and 64 deaths. The direct cause
of these infections was fungal contamination of methylprednisolone that led to the development of fungal
meningitis. Perhaps the most shocking detail of the NECC case is that the investigation revealed the company
knowingly distributed drugs that were potentially contaminated for nearly six years.

This case is a perfect example of why environmental monitoring alone isn’t enough for pharmacies — corrective
actions MUST occur when environmental monitoring indicates there are potential contamination problems.
That’s why it’s essential for facility managers to have a strong understanding of the national consensus
standards USP 797 — which sets forth guidelines for sterile drug compounding — and USP 800 — which deals
specifically with hazardous drug compounding. The Joint Commission and CMS have since adopted both of
these standards as a requirement for compliance.

The Problem with Sterile Drug Compounding Compliance

Guidelines for improving pharmacy quality have been around for years, but USP 797 has only been official
since 2004. Many pharmacies — particularly hospital pharmacies — were designed before such stringent
requirements were put into place. This means many pharmacies are now scrambling to catch up and become
compliant. In fact, we conducted a survey about USP 797 and USP 800 compliance and found that only about
half of respondents were currently in full compliance with 797 and less than 10 percent were in full compliance
with 800.

Infection Prevention & Control Within the Physical Environment: 4 High Risk Areas Healthcare Facility Managers Need to Know 12
Given the changes that need to be made in order to reach compliance, this shouldn’t come as much of a
surprise. Many of the respondents to the EH&E survey indicated they had updates and renovations in effect
that would increase their compliance. When asked what was their biggest current challenge to achieving
compliance, respondents listed financial and budgetary concerns as the top challenge, with limitations to the
sterile compounding physical plant coming in a close second.

While these challenges aren’t surprising, they are problematic. As compliance requirements with USP 797
and USP 800 become more and more stringent, facility managers of compound drug centers and hospital
pharmacies need to be aware of the steps to full compliance and have a plan in place to meet requirements
sooner rather than later.

Hazardous Drugs and USP 800

Though USP 800 only became its own consensus standard recently (effective July 1, 2018), many of the same
requirements have been written into other guidelines in the past (such as NIOSH). However, the USP expert
committee determined that risk from hazardous drugs warranted the creation of an entirely separate standard,
and therefore published USP 800.

For healthcare workers who handle hazardous drugs, there is no real known safe exposure — which is why
limiting exposure as much as possible is important. Since hazardous drug safety focuses as much on employee
health and safety as it does on the protection of the patient, all healthcare workers who handle hazardous
drugs should first go through hazardous drug training.

As with many physical environment infection prevention strategies, both pressurization and containment are
key to control the risk. Negative pressure provides a safeguard for employee protection and is crucial at each
stage of the hazardous drug handling process — from receiving, unpacking, and storing. USP 800 also requires
that pharmacies have a separate room for storing hazardous drugs with a separate refrigerator, in order to
keep them away from non-hazardous drugs and avoid contamination.

Achieving Compliance Under USP 797 and USP 800

Much of sterile drug compounding compliance comes down to pharmacy layout. Since pressure relationships
will change based on what types of drugs are being prepared and where, layout and careful consideration of
adjacencies is essential.

Unfortunately, for many pharmacies, this means undertaking renovation projects, particularly to create
cleanrooms that may not have existed prior to regulation changes. In a “State of the Industry Survey” from the
April 2016 issue of Pharmacy Purchasing and Products Magazine found that more than half of respondents had
cleanroom renovations planned within the next three years.

Infection Prevention & Control Within the Physical Environment: 4 High Risk Areas Healthcare Facility Managers Need to Know 13
For many facility managers who may be overwhelmed with the process of becoming compliant, seeking out an
audit specific to USP could help provide some valuable insight on how to improve compliance without incurring
unnecessary costs.

Typical layout of a Cleanroom and antreroom.

Environmental Monitoring

While USP 797 has always required environmental monitoring, the frequency of sampling will increase in the
proposed revisions to USP 797. For example, while viable air sampling and surface sampling were required to
be completed semi-annually, the proposed updates have this requirement increasing to at least monthly.

In addition to having proper monitoring processes in place, it’s also crucial for pharmacies and sterile drug
compounding companies to understand the root causes of contamination issues. Studies have shown that
more than 50 percent of contamination is caused by people — with surfaces, equipment, air pressure, and
water quality also contributing.

Since increased sampling leads to increased data volume, hospital pharmacies need to establish a
system that allows for automated processing and data interpretation. In order to ensure that data can be
interpreted in an accurate and timely manner to prevent issues, automating these processes and enlisting
the help of experts to fully determine risks and appropriate corrective actions is highly recommended. With
the right processes in place, environmental monitoring efficiency and compliance can be greatly improved.

Infection Prevention & Control Within the Physical Environment: 4 High Risk Areas Healthcare Facility Managers Need to Know 14
Conclusion

When vulnerable patients come to hospitals, they have enough to worry

about without considering infections from sources within their physical
environment. By positioning themselves as a frontline of defense against
these infection risks, facility management working closely with infection
prevention teams can help ensure their hospital mitigates these
important infection risks that can lead to HAIs.

Prioritizing the understanding and assessment of infection risks is now a key responsibility for facility
managers. From there, facility managers can establish programs to mitigate risks and facilitate communication
between departments to avoid compliance breakdowns. And speaking of compliance, having a deep knowledge
of the various regulatory standards and agencies will help get your hospital on the way to full, continuous
compliance across the board.

Above all, healthcare facility managers and the rest of an institution’s leadership team need to be proactive
in their efforts to reduce facility-related infections. While obtaining compliance is a complex process
requiring time and resources, it is well worth the effort to safeguard patients, control costs, and reduce
institutional risks.

Infection Prevention & Control Within the Physical Environment: 4 High Risk Areas Healthcare Facility Managers Need to Know 15