Transcript Session Title – Two Lines if Needed

“Study of Several Well-Publicized InstrumentReprocessing breaches within the
Veterans Health Administration.”
Lawrence F. Muscarella, Ph.D.
Director, Research and Development
Custom Ultrasonics, Inc.
Tennessee SGNA’s
29th Annual Educational Course
Embassy Suites
820 Crescent Centre Drive
Franklin, TN
Build Your
Knowledge
With
Us
Saturday, October 15 -17, 2010
8:15a - 9:15a
Founder: www.MyEndoSite.com and “The Q-Net Monthly.”
THIS LECTURE’S OBJECTIVES:

The primary objectives of this morning’s lecture are to:
1.
Discuss the infection-control breaches identified at three
VA medical centers (VAMCs) located in Murfreesboro, TN;
Augusta, GA; and Miami, FL.
2.
Focus on the clinical significance and root causes
of the breaches identified in Murfreesboro (TN).
3.
Briefly discuss the reprocessing breach identified at the
VAMC located in San Juan, Puerto Rico, and the
VAMC located in St. Louis, MO.
4.
Provide recommendations to prevent infection
during flexible and GI endoscopy.
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BACKGROUND
 In 2008 and 2009, reprocessing breaches involving flexible
endoscopes were identified at 3 different medical centers
within the Veterans Health Administration (VHA).
– These 3 VA medical centers (VAMCs) are located in:
(1) Murfreesboro, TN; (2) Miami, FL; and (3) Augusta, GA.
 Reports note that these breaches may have exposed
more than 10,000 patients to infectious agents –
including HIV and the hepatitis B and C viruses.
› One patient is suing the VA for $10 million, alleging she
contracted hepatitis C at the VA in Augusta (GA) from
an improperly cleaned flexible laryngoscope.*
* Source: The Augusta Chronicle. July 6, 2010.
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1. What happened in Murfreesboro, Tennessee?
A.
In December, 2008, several infection-control breaches
were identified at the VAMC in Murfreesboro, TN
(Alvin C. York Campus).
›

Blood was observed in the auxiliary water system
used during colonoscopy.
Breach: An investigation confirmed that
for as many as 5 years:
›
this VAMC had been misusing the Olympus
MAJ-855 Auxiliary Water Tube such that:
1)
Auxiliary water system
instead of being fitted with the requisite
one-way valve, the MAJ-855 irrigation tubing had been:
— fitted with an improper two-way connector, permitting
the back-flow of blood into the MAJ-855 tubing.
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Enlarged diagram of happened in Murfreesboro, TN
1)
the MAJ-855 Auxiliary
Water Tube
2)
Its one-way valve
3)
The short (“OFP”)
irrigation tube
4)
The Olympus flushing
pump (OFP)
Enlarged: The Olympus auxiliary water system used during colonoscopy. *
* Source: VA Office of Inspector General. Use and Reprocessing of Flexible Fiber-optic Endoscopes
at VA Medical Facilities. Report No. 09-01784-146 June 16, 2009. Washington, DC 20420.
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A 2nd diagram of what happened in Murfreesboro, TN
This is Olympus’s
MAJ-855 Auxiliary
Water Tube used
for irrigation
Note the MH-974’s
single-winged
valve, which allows
bi-directional flow.
This is Olympus’s
MH-974
Washing Tube
Note the MAJ-855’s
correct valve - which
is double-winged and
restricts flow in the
wrong direction.
Note: Ensure that
these two valves
are not being
switched and used
interchangeably.
Images from: VA Patient
Safety Alert. 12-22-08;
AL09-07.
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1. What happened in Murfreesboro, Tennessee?
›
This investigation also determined that for as many as
5 years this VAMC in Murfreesboro had been:
2)
improperly reprocessing the MAJ-855 tubing.
— Specifically, this tubing was cleaned and high-level
disinfected (or steam sterilized)
› only once at the end of the day,
 not after each patient procedure
(whether or not the auxiliary water
system was used during the procedure).*
* Source: Olympus America. Important Safety Notice. February 11, 2009. Pages 1-4.
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1. What happened in Murfreesboro, Tennessee?
3)

And, third, the short OFP irrigation tube - that connects
the MAJ-855 to a OFP flushing pump - was not
discarded at the end of the day,
but was typically reused.
Infection risk: The improper fitting of the MAJ-855 tubing
with the MH-974’s similar-in-appearance two-way
connector (instead of the correct one-way valve)
can facilitate:
›
the “back-flow” of blood and other potentially infectious
debris from the patient’s colon into the MAJ-855
auxiliary water tube.
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1. What happened in Murfreesboro, Tennessee?

The contamination of the MAJ-855 tubing,
›
coupled with the failure to clean and
high-level disinfect (or sterilize) it
after each patient procedure
—

can result in the patient-to-patient transmission of such
infectious agents as the hepatitis C virus.
Further, failure to throw out the short OFP irrigation tube
at the end of each day similarly poses an increased
risk of its contamination and of patient infection.
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2. What happened in Miami, Florida?
B.
Infection-control breaches were also identified the next
month at the VAMC in Miami, FL, in January, 2009
(Bruce W. Carter VAMC).
›

As a result of the publicized breaches in TN,
an inspection was performed at this VAMC
in FL, to certify compliance with the VHA’s
procedures for endoscope reprocessing.
Breach: During this inspection, this VAMC discovered
that for as many as 5 years:
1)
it, too, had not been reprocessing the Olympus MAJ-855
auxiliary water tube after each procedure.
—
Rather, this VAMC had been merely rinsing the
MAJ-855 tubing with (sterile) water; further …
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2. What happened in Miami, Florida?
2)
This VAMC often connected the MAJ-855 tubing
to the colonoscope after the procedure
had already began;
3)
it did not discard the short OFP irrigation tube
at the end of each day. (Remember that this
short tube connects the MAJ-855 tubing
to the OFP flushing pump). And,
4)
during this inspection, potentially infectious “debris” was
identified in the auxiliary water channel of ostensibly
“reprocessed” and “patient-ready” colonoscopes,
indicating their improper reprocessing.
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2. What happened in Miami, Florida?

Infection risk: The failure:
a.
to clean and high-level disinfect the (or steam sterilize)
the MAJ-855 auxiliary water tube after
each patient procedure;
b.
to connect the MAJ-855 tubing to the colonoscope,
with the auxiliary water system primed,
prior to the procedure;
c.
to discard the short OFP irrigation tube at the
end of each day; and
d.
to clean and high-level disinfect the colonoscope
thoroughly, including its auxiliary water
channel, after each procedure;
›
poses an increased risk of disease transmission.
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3. What happened in Augusta, Georgia?
C.
And, third, infection-control breaches were identified
at the VAMC in Augusta, GA, in November, 2008
(Charlie Norwood VAMC).
›

A patient in the “ENT” clinic questioned the method by
which a nurse reprocessed a flexible laryngoscope.
Breach: For almost a year, this VAMC had been:
›
improperly cleaning and high-level disinfecting
flexible laryngoscopes between uses.
›
Specifically, staff were merely wiping the external
surfaces of the laryngoscope with a disposable
“sanitizing” cloth - which achieves, at best,
intermediate-level disinfection.
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3. What happened in Augusta, Georgia?

Infection risk: The failure to clean and, at a minimum,
to high-level disinfect flexible endoscopes have been
causally linked to disease transmission, with
associated patient morbidity and mortality.

Briefly, flexible endoscopes, such as
›
GI endoscopes and bronchoscopes
—
›
are semi-critical instruments that require high-level
disinfection or sterilization after each use.
The use of a low-level or intermediate-level disinfectant
is permitted only for non-critical items, such as
bed pans and environmental surfaces.
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A root cause analysis (RCA) of the breach in TN
 Let’s now focus on the VAMC in Murfreesboro, TN, and the
root cause analysis (RCA) it performed and published.
› This RCA considers all of the factors that this VAMC
concluded could have potentially contributed to,
or caused, this VAMC’s identified breaches.
 Some of the notable factors that this published RCA
concludes contributed to this VAMC’s breaches include:
›
that the design of the MAJ-855 tubing’s one-way valve
(which is not permanently sealed in place) is too
similar in shape, size, color, and appearance …
—
… to the MH-974’s improper two-way connector,
facilitating confusion, their interchangeable use,*
and the contamination of the MAJ-855 tubing.
* Source: Root Cause Analysis (RCA) Form. Case ID: JP0141. pp. 1-4 (Dated 1/20/09)
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A root cause analysis (RCA) of the breach in TN
 Some additional notable factors that this published RCA
concluded contributed to the reprocessing breaches
at this VAMC include:
›
Manufacturer instructions that did not clearly elucidate:
— how
often the MAJ-855 tubing is to
be reprocessed;* and
— when
the short OFP irrigation tubing
is to be discarded.*

For example, after every procedure;
once a day or week?
* Source: Root Cause Analysis (RCA) Form. Case ID: JP0141. pp. 1-4 (Dated 1/20/09)
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4. What happened in San Juan, Puerto Rico?

Now, let’s discuss similar reprocessing breaches that were
identified during the summer of 2009 at a few medical
facilities within the VA Caribbean Healthcare System.
–

These medical facilities include a VAMC in San Juan (PR).
These reprocessing breaches at these several facilities
included, among others:

faulty reprocessing of transvaginal
ultrasound transducers;

failure to leak test colonoscopes; and

improper reprocessing of flexible endoscopes.
To read this article, visit: www.MyEndSite.om/articles/SanJuanWeekly.pdf
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4. What happened in San Juan, Puerto Rico?
 The “San Juan Weekly” * (June 24-30, 2010) reports that,
as a consequence of these reprocessing breaches:
“thousands (of patients could)
be at risk (of infection) in
Puerto Rico and the
Virgin Islands.”
 Let’s focus on the infectioncontrol breach identified at the
VAMC in San Juan, PR, during
the summer of 2009.
›
A complaint was
filed alleging that
flexible
laryngoscopes were
not being properly
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4. What happened in San Juan, Puerto Rico?

Breach: For possibly as many as 9 months, this VAMC’s
radiotherapy department had been improperly
cleaning its flexible laryngoscopes after
each procedure.*
›
Specifically, it “cleaned” its flexible laryngoscopes
by merely rinsing them with running water
(followed by drying with a clean gauze pad) …
— without using a detergent.
* Source: Department of Veterans Affairs Office of Inspector General. Healthcare
Inspection: Patient Safety Issues VA Caribbean Healthcare System San Juan,
Puerto Rico. Report No. 09-03055-103 March 16, 2010. Washington, DC
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4. What happened in San Juan, Puerto Rico?

Infection risk: As we have discussed, the improper cleaning
(and/or high-level disinfection) of flexible endoscopes have
been causally associated with disease transmission.
›
Further, the VAOIG investigating this breach acknowledged
in its report the potential for infection whenever a
flexible endoscope is improperly cleaned, stating:
—
“without proper pre-cleaning, adequate (high-level)
disinfection cannot be ensured.” *

I agree, and my assessment of the risk of infection
associated with this specific breach is discussed
in this “San Juan Weekly” front-page article.
* Source: Department of Veterans Affairs Office of Inspector General. Healthcare
Inspection: Patient Safety Issues VA Caribbean Healthcare System San Juan,
Puerto Rico. Report No. 09-03055-103 March 16, 2010. Washington, DC
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4. What happened in San Juan, Puerto Rico?

Let’s compare and recognize the striking similarities between
this reprocessing breach identified at the VAMC in San Juan
(PR) and the breach identified at the VAMC in Augusta (GA).
—
In fact, the VAOIG confirmed the same breach at both VAMCs:
›
—
namely the improper cleaning of flexible laryngoscopes.
Yet, whereas the VHA notified 1069 patients of the
breach in Augusta, it inexplicably did not notify any
of the patients in San Juan of the same breach.
›
In short, the VHA concluded that improper reprocessing
of flexible laryngoscopes in Augusta posed an
increased, if significant, risk of infection, …

while the VHA dissimilarly concluding that this same
breach in San Juan pose a “negligible” risk.
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4. What happened in San Juan, Puerto Rico?
›
These two incongruous assessments of risk are puzzling
and have important public-health and
quality-assurance implications.
›
These two risk assessments led the “San Juan Weekly”
to ask: “Why were patients in Puerto Rico not notified?”
›
As I was quoted as saying in this newspaper article:
›
“Based on the available data, the risk of infection
associated with (this specific breach in San Juan)
would (not) be negligible,” and would be “sufficiently
significant to warrant the notification of veterans
and other patients of the potential for their
exposure to infectious agents.”
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5. The VAMC in St. Louis – what happened?
›
That the patients at the VAMC in San Juan were not notified of
its failure to use a detergent to “clean” its flexible
laryngoscopes and the associated risk of infection …
›
›
is that much more surprising, when viewed in the context,
not just of the breach in Augusta, but also of the recent
breach at the dental clinic of the VAMC in St. Louis (MO).
Briefly, the VAMC in St. Louis this past July (2010) notified 1812
patients of the potential risk of infection associated with the
failure to use a detergent to “clean” dental instruments, rinsing
them only with water prior to sterilization.
›
According to the VHA: “Because we weren't using the
detergent, this might reduce the efficiency of
sterilization. We just don't know.“
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Recommendations to prevent disease transmission:
Recommendations to prevent the risk of disease transmission
during flexible and GI endoscopy will be presented during the lecture.
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The End
Thank you for your attention to
and interest in these topics.
For questions or a list of this lecture’s references,
please contact me directly at:
[email protected]
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