How prepared is your lab? Can it handle infectious diseases like Ebola? MD Buyline recommends certain instruments and pricing for point of care systems for bedside testing. View the full article at http://www.mdbuyline.com/blog/contained-laboratory-ebola-infectious-disease-preparedness/.

1. Ebola Preparedness in the
Laboratory
In light of the Ebola cases seen in Texas, Nebraska and now
New York, hospitals in the U.S. are reviewing their infectious
disease preparedness plans. The Centers for Disease Control
and Prevention (CDC) recommends risk assessments are
conducted by each laboratory director, biosafety officer or other
responsible personnel to determine exposure risk and course of
action that best fits the facility. For the laboratory, this includes
procuring dedicated equipment (preferably disposable) that can
be used for routine laboratory testing of infectious patients
separate from those used in the main lab.

2. Dedicated Bedside Lab Instruments
Since the lab is a highly regulated area of the hospital, shifting
routine testing from the lab to the bedside will require equipment
that can meet those same regulatory requirements.
MD Buyline has gathered instrument recommendations and
pricing for systems that meet these needs in the table below.
These point of care (POC) instruments offer ease of use and
portability for bedside testing, allowing testing to be performed by
non-lab personnel.

3. Dedicated Bedside Lab Instruments
This eliminates the need to send routine tests (e.g., Complete
Blood Count, Chemistry Panel) to the main laboratory, minimizes
potential infectious disease exposure to lab personnel and
reduces laboratory downtime for infectious disease cleaning and
maintenance. POC testing can also be set up in a confined space,
such as a containment area. The low cost of these instruments
allows them to be disposal at end of use.

4. Dedicated Bedside Lab Instruments
In the table, the asterisk identifies the top instrument choices for
the various disciplines. These were selected based on their ease
of use, quality of results, cost to purchase and maintain and
portability. They are also the disposable systems of choice by top
hospitals. Please note, this list is not meant to be exhaustive and
includes optional instruments to meet the various needs of a
hospital. Consumable considerations for all instruments can vary
based on the volume and type of testing done.

5. Dedicated Bedside Lab Instruments
The i-STAT in particular is unique in that it is a multi-function POC
instrument that can run limited chemistry, blood gas, coagulation
and hematological parameters.

6. Dedicated Laboratory Equipment
Recommendations & Pricing

7. Dedicated Laboratory Equipment
Recommendations & Pricing
When considering bedside or POC testing, laboratory personnel
should consider the waived testing options that are available.
These offer less stringent accreditation requirements compared to
those that are non-waived and meet the following criteria:
• Simple laboratory procedures
• Insignificant risk of erroneous result
• FDA approved for home use
• Pose no reasonable harm if performed incorrectly

8. Dedicated Laboratory Equipment
Recommendations & Pricing
Performing tests at the bedside does not exclude the instruments
from having to meet regulatory requirements, nor does it include
testing for the Ebola virus which is only performed by the CDC.
The recommendation is solely to provide hospitals preparing for
infectious disease treatment with options for dedicated
instrumentation that can meet their immediate needs to test
infected patient blood and bypass the main laboratory process.

9. Instrument Procurement Recommendations
A direct purchase may be the best option for infectious disease
preparedness. An agreement such as lease, reagent rental or cost
per test may not be the best option for this situation as the
likelihood of prolonged testing and use is minimal. Minimizing
extended costs will make the instrument more disposable than
committing to a long-term agreement. Vendors may be able to
provide free samples of some of the equipment for a limited
amount of testing at the time of purchase.

10. Instrument Procurement Recommendations
Consumable agreements can be for a 12-month term rather than
the standard five years. In the event that an infectious patient is
admitted, additional products can be ordered at that time to meet
the demands. Keep in mind that some instruments require daily
start-up and shut-down procedures that will need reagents to
function.
For facilities that already have these instruments in use, we
recommend shifting older instruments for the infectious disease
involvement and using newly purchased equipment for daily use.

11. Instrument Procurement Recommendations
Discuss what options are available with vendors to shift service
and reagent agreements already in place with older equipment to
find extra savings. A service agreement past the 12-month
warranty may not be necessary. Some instruments listed come
with a 36-month warranty, negating the need to purchase
additional service. Additional reagent and service needs can
always be revisited at the end of the contract, although we always
recommend negotiating reagent and service needs at the time of
purchase even if they are to be purchased after contract
expiration.

12. Instrument Procurement Recommendations
Be sure to have a laboratory technical procedure or Standard
Operating Procedure (SOP) for each dedicated instrument
available at the testing site. If an existing technical procedure is
not available, vendors may be able to provide a sample procedure
that can be customized and used by testing personnel. The
procedures may include appropriate infectious disease warnings
for non-lab testing personnel.

13. Instrument Procurement Recommendations
Non-lab personnel performing testing on dedicated instruments
should be trained in the proper use and maintenance of these
instruments by a qualified individual. The technical procedure
should be readily available in the event that questions arise, but it
should not be a substitute for hands-on training.

14. Funding and Grant Opportunities
On October 16, the House Energy and Commerce Subcommittee
on Oversight and Investigations held a hearing in which members
expressed concern that budget cuts to the CDC and National
Institutes of Health (NIH) as well as other public health programs
hampered the nation’s progress in stopping the disease and
impacted the development of an Ebola vaccine. Rep. Peter Welch
requested a hearing for the subcommittee to focus on the funding
needs of the NIH and CDC, as well as the nation’s infrastructure.
It was noted by Chairman Murphy that the subcommittee will hold
a follow-up hearing in November 2014, although no specifics were
provided on the topics of discussion.

15. Funding and Grant Opportunities
Historically, the Hospital Preparedness Program (HPP) and Public
Health Emergency Preparedness provide funding through grants
and cooperative agreements to states, territories and eligible
municipalities to improve surge capacity and enhance community
and hospital preparedness in the event of a public health
emergency. The U.S. Department of Health and Human Services’,
Office of the Assistant Secretary for Preparedness and Response
and CDC provide instructions for Preparing an Interim Progress
Report, which outlines the eligibility and application submission
process.

16. Funding and Grant Opportunities
Facilities seeking funding from the state or federal programs may
need to provide pricing information for cost-based or charge-
based reimbursement for instruments used in infectious disease
preparedness. More information on grants can be found at
www.grants.gov.
It is unknown at this time how much (if any) reimbursement will be
available for hospitals participating in Ebola preparedness.

17. Funding and Grant Opportunities
In the past, the HPP along with state and local health departments
have purchased healthcare facility based equipment and supplies,
trained and collaborated to address situations like Ebola and other
infectious diseases. In the meantime, hospitals can focus on
preparedness logistics until the details on funding availability
become clear.

18. Moving Forward
Every department in the hospital will face unique challenges in
establishing and managing preparedness for possible infectious
disease cases. In the laboratory setting, providers will need to
determine if they want to continue current processes which would
include routing testing through the laboratory and utilizing either
primary or backup equipment or if they want to test at the beside.
In either case, laboratory personnel should stay informed on
current CDC recommendations for evaluating Ebola patients in
the lab and managing the continued care of patients with
confirmed cases.