How to Identify and Analyze a

Hospital Risk Assessment

Posted by Jason Di Marco on May 04, 2017

NFPA and other certifying agencies have narrowed their philosophy for the
inspection and certification of hospitals from an occupancy-based code to a
Risk Based philosophy. This requires the hospital to identify potential dangers
and faults in all their systems and have on hand a written policy to handle
equipment maintenance and failures.

This plan is Risk Assessment.

Bonus Content: Download our free PDF on Risk Assessment. Easily save it
to your computer or print for reference.

Risk Management Part of the Higher Plan

“Risk management is a structured approach to managing uncertainty related
to a threat, through a sequence of human activities including risk assessment,
strategy development to manage risk and mitigation of risk using managerial
resources.

The strategies could include transferring the risk, to another party, avoiding
the risk, reducing the negative effect and accepting some or all of the
consequences of a particular risk.” Nadeem Baig, HSE

Several surveyors are asking for or requiring Risk Assessment plans as

part of their inspection routine. Other than the general principles outlined
here, specific detailed guidelines for equipment, processes or buildings are
still being formulated.

In general, risk assessment asks:

 What can go wrong?

 How bad could it be?
 What action should be taken?
 How often might it happen?
 How do we avoid this problem in the future?

6 Steps to Provide a Remedy for an Identified Risk

Step 1: Research - Identify what failures or incidents can cause damage.

Step 2: Identify who or what could be injured or displaced by such a failure or

event: patients, staff or the public.

Step 3: How critical would the damage be if the defect took place.

Step 4: How likely is this problem to happen?

Step 5: Create a remedy or procedure to work around the adverse event and
identify the responsible parties.

Step 6: Review the corrective action plan with staff to make sure they
understand and can fulfill their responsibilities in the event of a defect
occurring.

The events you identify should be filtered through a grid like the one below
that clarifies the importance and urgency of action to remedy the problem and
value the risk of a bad outcome.

Immediate Threat to Life

source: The Joint Commission

List Equipment to Prepare for Remedies

ASHE provides a spreadsheet to list equipment and areas of the hospital that
are important to patient care and from there you can individually plan the
remedies for failures that may occur at these sites.

NFPA, CMS and TJC require an inventory of equipment to be available during

inspection and for medical gas purposes that would be the starting point of
filling out the equipment grid from ASHE below.

Risk Assessment Form Example

Those hospitals using the CHx software should be able to get the inventory
identification information directly from the program. (i.e. Asset description,
manufacturer, model #, all historical inspection data).
Hospital Risk Assessment Defined by Risk to Patient
Risk based assessment assigns a value to each asset by their use and their
potential to be harmful to the patients or staff. For example, an oxygen outlet
in an emergency room would have the highest urgency while the outlet in the
storeroom would have the lowest priority.

The hospital in conjunction with the inspecting company following NFPA

guidelines would establish an urgency level to each device and then set an
inspection and repair schedule for the assets based on the risk rating to
patients rather than the date on the calendar.

Building System Categories Defined by Threat

The categories are broken down into harm to patients, staff and visitors.

1. Failure may cause death or serious injury

2. Failure limited to minor injuries

3. Failure may cause discomfort

4. No impact on patients or caregivers

source: whea.com

Category 1 - The system must always be highly functional. An example in

this category would be a medical gas system in an ICU.

Category 2 - A system failure would not involve risk to life. High

dependability is expected in this category.

Category 3 - Failure would cause discomfort but not likely to cause injury.

Category 4 - Patients are not adversely affected.

All building system categories will be driven by ensuing the risk assessment
procedures.

Maintenance Programs and Risk Assessment

The Joint Commission identifies the activities and frequencies for maintaining,
inspecting, and testing for all operating components of utility systems.

Various maintenance strategies may be used to ensure reliable performance

(for example, predictive maintenance, reliability-centered maintenance,
interval-based inspections, corrective maintenance, or metered maintenance).
Defined intervals may be based on criteria such as manufacturers’
recommendations, risk levels, and current organization experience.

According to Standard EC.02.04.01, the organization manages medical

equipment risks. Also in agreement under the Elements of Performance for
EC.02.04.01 A 2, the organization maintains either a written inventory of all
medical equipment or a written inventory of selected equipment categorized
by physical risk associated with use (including all life-support equipment)
and equipment incident history.

The organization evaluates new types of equipment before initial use to

determine whether they should be included in the inventory.

Alternative Equipment Maintenance Programs

TJC and CMS allow Alternative Equipment Maintenance programs (which
deviate from the manufacturer’s suggested intervals) if the hospital can prove
with historical and industry data that the alternative program will keep up
equipment performance. These alternative programs must be supported by
the Risk Assessment that has become the standard philosophy to assess
hospitals.

“The Joint Commission standards are not prescriptive with regard to tasks and
frequencies for piped medical gas and vacuum systems. In accordance with
EC.02.05.09, for each piped medical gas and vacuum system, the source,
distribution, inlets/outlets, and the alarms that protect the systems are to be
maintained in a safe and reliable condition. These are considered high-risk
utility systems.

In accordance with EC.02.05.01, the organization is to develop a maintenance

strategy based upon manufacturer's recommendation or an alternative
equipment maintenance (AEM) strategy. Issues such as system complexity,
system age/condition, patient acuity, etc. are to be used to assess
maintenance strategies.
NFPA 99 Appendix C can be used as a guide for establishing a maintenance
strategy, but appendix material are not requirements unless adopted by a
controlling authority. The survey process will evaluate the maintenance
strategy assessment process for effectiveness, and validate that it has been
properly implemented. [EC.02.05.09]

Release of TJC Elements of Performance

TJC-accredited hospitals, for example, now face an even more important
reason for having an effective AEM-inclusion risk assessment
process since the official 1-9-2017 release of TJC’s updated Elements of
Performance. The broad utility system inspection, testing & maintenance
(ITM) Standard EC.02.05.05 contains newly changed language concerning
required utility ITM completion rates.

The impacts of the updated EP language issued on 1-9-2017 basically

require:

In EC.02.05.05 EP-4: 100% on-time compliance for all High Risk utility system
components, whether done through the Alternative Equipment Maintenance
(AEM) program or done in accordance with manufacturer’s
recommendations;

In EC.02.05.05 EP-5: 100% on-time compliance for all Infection Control utility
system components, whether done through the AEM program or done in
accordance with manufacturer’s recommendations;

In EC.02.05.05 EP-6: down to not less than 90% on-time compliance for other
Non-High Risk components done through the AEM program only if the
organization’s policy (presumed to be the utility systems equipment AEM
Program policy) permits such deferral.

In other words, TJC accredited hospitals have some flexibility to mandated

100% on-time Inspection, Testing and Maintenance compliance only for their
non-high-risk and non-infection control utility system components that are
managed through an acceptable Alternative Equipment Maintenance
Program.

Critical Factors to Consider When Evaluating Risks

Associated With Equipment
Whether equipment is critical (TJC high-risk) equipment is one of the tests. It
may even be the most important factor to consider, but it is not the only
factor.

Within The State Operations Manual, Appendix A – Survey Protocol,

Regulations and Interpretive Guidelines for Hospitals, A-0724 (Rev.);
Interpretive Guidelines §482.41(c)(2), CMS states “Factors for a hospital to
consider when evaluating the risks associated with a particular type of
equipment include, but are not limited to:

 "How the equipment is used and the likely consequences of equipment

failure or malfunction – would failure or malfunction of the equipment
hospital-wide or in a particular setting be likely to cause harm to a patient
or a staff person?”
 “How serious is the harm likely to be?”
 “How widespread is the harm likely to be?”
 “Information, if available, on the manufacturer’s equipment maintenance
recommendations, including the rationale for the manufacturer’s
recommendations;”

Maintenance requirements of the equipment:

 Are they simple or complex?

 Are the manufacturer’s instructions and procedures available in the
hospital, and if so can the hospital explain how and why it is modifying the
manufacturer’s instructions?
 If the manufacturer’s instructions are not available in the hospital, how does
the hospital assess whether the AEM uses appropriate maintenance
strategies?
 How readily can the hospital validate the effectiveness of AEM methods for
particular equipment? For example, can the hospital explain how it ensures
there is no reduction in the quality of the performance of biomedical
equipment subjected to alternate maintenance methods?”
 “The timely availability of alternate devices or backup systems in the event
of equipment failure or malfunction”
 “Incident history of identical or very similar equipment”

CMS also stated “Generally multiple factors must be considered, since

different types of equipment present different combinations of severity of
potential harm and likelihood of failure. The hospital is expected to be able to
demonstrate to a surveyor the factors it considered in its risk assessment
for equipment placed in its AEM program.”
"Legacy computerized maintenance management systems (CMMS) generally
do not adequately address these AEM inclusion risk assessment
requirements with their original risk assessment programming. This situation
appears to be because the newly required risk assessment factors are
generally not the same as the more commonly-used factors that hospitals
have used in past utility system risk assessments. A new risk assessment
framework appears to be required to support AEM-inclusion decisions.”

Suggested CMS Checklist to Identify Risks and Their

Protections and Remedies
source: CMS.gov

For general hospitals performing anesthesia the risk level for medical gas
equipment is always high as they sustain life and their interruption would likely
cause death or serious harm to patients and perhaps other equipment, except
in Category 3 or 4 facilities.

The default inspection and testing regime for medical gas equipment has
been the Manufacturer’s suggested frequency. This usually means: annually
for equipment like outlets, inlets, valves and alarms and quarterly for active
source equipment like pumps and compressors and monthly for power
changeover test systems.

Emergency Operations Planning

One other area that has gained current attention is emergency planning for
larger scale shutdowns that will mean unusually large numbers of patients and
damaged utility systems that will strain hospital normal operations.

Here are the suggested questions from one agency:

Emergency Operations Planning

 Life Supporting Equipment

o Oxygen, Medical Air, Vacuum (Potential Systems)
 How will you ensure systems are available during an emergency?
 What is the protocol for monitoring systems during the emergency?
 How will the Emergency Operations Plan be activated / deactivated?
 Will the plan meet the (96) Hour Sustainability Requirement?
 Staff must be educated on their specific duties and responsibilities.
 Some Options for Contingencies:
o Cylinders available for critical care patients
o Temporary back feed of all critical care portions of the system
o Portable vacuum systems available for critical care areas
o Suppliers temporary bulk oxygen trailer (Might not be practical)

Conclusion
As the various agencies collaborate on their reporting standards and methods
the responsibility of the hospital to identify and maintain equipment is
paramount.
The surveyors may well ask for an inventory of any or all equipment in the
hospital including its maintenance history for at least the past two years. Any
equipment failures that lead to serious harm to patients or staff are likely to be
scrutinized as the process evolves. Detailed records of defective parts and
adjustments need to be recorded as well.

An exhaustive study by John Collins, FASHE, HFDP done for ASHE

Monograph determined the most frequently failing devices leading to patient
injury were circuit boards. Assuming this holds true for your hospital, the piped
medical gas system should be very reliable as the only circuit boards are in
the source equipment control panels and alarm panels.

This could mean more scrutiny on the activation and calibration of alarm
systems for medical gas. Motors and wear parts were far behind in terms of
creating failures, but many of these potential failures can be anticipated with
a regular preventive maintenance program.

The CHx program for medical gas systems provides the statistical history
base for your risk assessment program. With the asset identity details and
historical inspection data in hand, it is easier to fill in the grid above to satisfy
the inspecting agencies.

Please feel free to contact your CHT representative to answer questions

about your specific Risk Assessment plan.

Note: The ideas, words and illustrations in this article are a compilation of the
wisdom drawn from CMS, TJC, ASHE, NFPA and the NHS.

Topics: MEDICAL GAS COMPLIANCE

AUTHOR

Jason Di Marco
President at Compliant Healthcare Technologies, LLC
Jason Di Marco has been intimately involved with helping hospitals protect and improve their
medical piped gas systems from CHT's beginnings. He is certified by ASSE, NITC, and NFPA as an
inspector and installer and has worked with major institutions from construction to risk assessment
planning.