Articles, Blog

Lessons from an Outbreak Investigation

August 20, 2019


[ Music ]>>Hello and welcome to the Tune in
to Safe Healthcare Webinar Series. Today’s presentation is Lessons from an Outbreak
Investigation: Improving Medication Preparation, Use, and Infection Control
in Outpatient Oncology. This webinar is hosted by the Centers
for Disease Control and Prevention. CDC’s mission is to save lives and protect
the health and safety of Americans. This mission extends to healthcare quality. My name is Dr. Joe Perz. I serve as the team lead for Quality, Standards, and Safety within CDC’s Division
of Healthcare Quality Promotion. The featured speakers on today’s
webinar include Dr. Amber Vasquez, an Epidemic Intelligence Service, or
EIS, officer at CDC, Dr. Joel Acklesberg, a medical epidemiologist with New York City’s
Department of Health and Mental Hygiene, and finally, Dr. Lisa Richardson, Director of
CDC’s Division of Cancer Prevention and Control. Before we get started, we have a
few housekeeping items to cover. First of all, we do welcome
your input, your questions. Please submit any questions or comments you
have via your chat window that’s located on the lower left-hand side
of the webinar screen. You can do that any time
during the presentation. Questions will be addressed after all the
presentations conclude as time allows. To ask for help, please press
the “raise hand” button located on the top, left-hand side of the screen. To hear the audio, please ensure your
speakers are turned on with the volume up. The audio for today’s conference should
be coming through your computer speakers. In addition, a reminder that the slides
from today’s presentation will be provided to participants in a follow-up email. Thank you. Now it’s my pleasure to introduce
our first speaker, Dr. Vasquez.>>Afternoon, everyone. Thanks for joining us. So the investigation began on May 24th,
2016, when an infectious diseases physician at Hospital A notified the New York City
Department of Health and Mental Hygiene of two cases of Exophiola dermatitidis
bloodstream infection that occurred on May 14th and 15th of that month. This prompted review of microbiology
records at Hospital A’s laboratory to search for more cases, and two more were
found from April 8th and 22nd. All four of these case patients had an
underlying cancer and were receiving care from the same physician at an outpatient
oncology clinic, which we’ll call Clinic A. And because all these patients
were linked to the clinic, the provider at Clinic A started
calling other clinic patients back to have blood cultures drawn,
even though they weren’t sick. And on May 27th, a fifth case was found from
one of these surveillance blood cultures. That day, an FDA investigation was requested,
and the CDC team arrived to assist on May 31st. So we’ll start with a little bit of background. Exophiola dermatitidis, formerly
known as Wangiella dermatitidis, is a common environmental fungus found as
a black yeast or mold, and it has been seen in prior associated healthcare
outbreaks, including an outbreak of severe neurologic infections
associated with steroid injections from a compounding pharmacy in 2002. Infections with this fungus are quite
rare and generally affects the nervous or respiratory systems, so bloodstream
infections are extremely rare. But oncology patients are at higher risk
for them since they’re immunosuppressed from chemotherapy as well as their underlying
cancers, and they can also be at higher risk for bloodstream infections due to the
presence of long-term central venous catheters such as implanted port catheters and
peripherally inserted central catheters. And to give you a quick idea
of Clinic A, it’s a small, independently managed clinic that’s
unaffiliated with any hospital. Staff includes a physician, a
nurse, and a phlebotomist as well as a few staff running the front desk. And they do medical evaluations
as well as follow-up visits, phlebotomy and infused chemotherapy. Patients often use Hospital A, a nearby but
separate facility, for some select services such as in-patient admission or
procedures like port placement. So back to our investigation. Since fungal HIA outbreaks are often
associated with multiple types of fungi, we wanted our case definition to include
a broader range of fungal organisms. So a case was defined as any non-Candida
yeast or mold identified on culture of blood or CVC from a patient who received care at Clinic A during January
1st through May 31st, 2016. For case finding, we reviewed microbiology
records at Hospital A’s network laboratory, and we then reviewed Clinic A’s charts for the
January to May study period to identify patients who had a CVC in place or received
an IV medication at the clinic, focusing on IV medications in venous lines,
since these were all bloodstream infections. Since the fifth patient had no symptoms
and was only found because we did a survey on his blood culture, we asked all patients
with a CVC or who received an IV medication at the clinic to have surveillance
blood cultures drawn. And lastly, we reviewed the medical records
and death certificates of deceased patients to determine if a fungal bloodstream infection
might have contributed to their deaths. After the initial five cases were
identified, no additional cases were found after reviewing the micro records at Hospital
A. Review of the clinic records, however, did reveal an additional case from March who
had been seen at a hospital out of state. This patient was infected with another type
of fungus called Rhodoturula mucilaginosa, which is also a common environmental yeast. And after beginning collection of
surveillance blood cultures on patients who received an IV medication at Clinic
A, all further cases were identified by this method, for a total of 17 cases. None of the deceased clinic patients were found to have evidence of fungal
bloodstream infection. So case patients had a median age
of 64 years, and 59% were male, and all 17 case patients had an underlying
malignancy, mostly solid organ disease. All case patients also had a CVC present,
and nearly all of those were port catheters, and most patients were asymptomatic, having only
been identified from surveillance blood culture. Thirteen case patients were found to be
infected with Exophiola dermatitidis, two with Rhodoturula mucilaginosa,
and two were infected with both fungi. All 17 case patients were hospitalized for CVC
removal and to initiate antifungal therapy, including the 12 asymptomatic patients. Ninety-day mortality was 18%, with
three patients dying at 10, 74, and 78 days after diagnosis, respectively. We then performed a cohort investigation
of patients who received an IV medication at Clinic A to identify risk
factors for infection. One hundred fifty-three unique patients were
seen at Clinic A during the study period, and our cohort was just of 38 patients
who were exposed to an IV medication. Nine were excluded, with six deceased
and three declining to be evaluated, leaving 29 patients for subsequent analysis. Seventeen of those were cases, 12 non-cases. Since these were all oncology patients, we first
wanted to look at their chemotherapy exposures as a possible source of infection,
but no more than half of the 17 cases received any
single chemotherapeutic medication, making chemo an unlikely
cause of the infections. We also looked at other IV medications that are
commonly used in conjunction with chemotherapy, such as dexamethasone and ondansetron. But four of those medications were single use
for individual patients, and no more than 12 of the 17 cases received any
one of these medications, making those also unlikely
sources of the infections. However, all the cases as
well as all the non-cases, were exposed to a compounded IV flush
solution that was used to flush CVCs. And I’ll explain this a little
bit more in a couple of slides. Since this was a universal
exposure among cases and non-cases, we used alternative statistical methods to
evaluate if this was a significant risk factor and did so by exploring the dose
response relationship between the number of flushes received and case status. Median flushes for cases was 12, compared to four among non-cases,
yielding a significant P value. So what exactly is this compounded flush. Briefly, this was a solution compounded
at the clinic by taking a one-liter bag of normal saline and adding small amounts of
two antibiotics and a blood thinner to it. The resulting bag of compounded
flush solution was stored in a fridge and accessed multiple times a day with
individual ten-milliliter syringes drawn from the bag over a four- to
eight-week period until it was depleted. And this was a highly unusual practice. And so, we next wanted to see if
we could identify a single bag of fluid that could be the source. This broke down into three different
bags over the study period based on the date the bag was compounded. And bag number two was the only bag
to which all the cases were exposed and had a significant P-value
of less than 0.001. While we ideally could have done
microbiologic testing on flush bag number two, unfortunately bag number two, having
been compounded in February and depleted in April, was unavailable for sampling. Flush bag number three was
still in use in the clinic, but it showed no growth of any organisms. And environmental samples were taken
from areas and equipment at the clinic. They showed some growth of common environmental
fungi, but no Exophiola or Rhodoturula. We also performed whole genome sequencing on 14
case patient E. dermatitidis isolates as well as two other clinical isolates from New York
City that were unrelated to the outbreak, and historical isolates from other
US locations to act as controls. Blue dots on the dendrogram indicate cases, pink dots the two unrelated New
York City clinical isolates, and gray dots historical isolates. All the 14 cases are essentially identical, at 0
to 2% differences, and were not closely related to the other New York City isolates, which
was consistent with single-point source for the outbreak, namely the
compounded IV flush solution. So we performed infection control assessments to determine what might have gone
wrong with this IV flush solution. But before I detail that, there
are a couple of CDC documents that are applicable recommendations
for the outpatient oncology setting, including CDC’s guide to infection
prevention for outpatient settings and the basic infection control and prevention
plan for outpatient oncology settings. I’ll highlight here some of the key
practices that we observed that deviated from the standard recommendation. But this won’t be a comprehensive list of CDC’s
recommendations or what we found at the clinic. Regarding general infection
control practices and procedures, it’s recommended to have written
policies and procedures based on evidence-based guidelines,
regulations, or standards. But no formal or written policies or
procedures were found at Clinic A, nor could we identify an
individual that would be designated to enforce infection control standards. It’s also recommended by CDC that all
healthcare personnel who are involved in direct patient care receive
infection control training upon hire and that this be repeated annually or
any time policies or procedures change. At Clinic A, only one staff member had
reportedly received infection control training four years prior, but no
documentation could be provided. Regarding injection safety, medications
should be drawn up in a designated, clean medication area to avoid contamination
from any nearby unclean or used items. At Clinic A, no designated clean medication
area existed, and IV medications were drawn up in multiple areas of the clinic,
including in the lab area and patient rooms. Clinics should also avoid pre-filling
and storing batch-prepared syringes, but at Clinic A, batches of IV flush syringes from the compounded solution were being
prepared every morning based on the number of patients scheduled for that day, and
this was occurring for weeks at a time with repeated entry allowing
for more opportunities to potentially contaminate the solution. The recommended practice for storage of
medications when they require refrigeration is to do so in a dedicated labeled refrigerator,
but the IV flush solution bag and syringes at Clinic A were stored in a
refrigerator that reportedly was also used for the occasional storage of staff food items. Here is a photo showing the chemotherapy
infusion area at Clinic A. In the back left is where most medications were stored, and
in the back right was the laboratory area, and the nurses standing near the
refrigerator where the flush bag was stored. As you can see, all these areas directly
connect, and there’s no separation between where medications were prepared
and where patients were treated. And in the upper right-hand photo
is the interior of the small fridge where the flush solution was kept. And visible grime can be seen on the bottom. But also in this fridge was
a plastic baggie stuffed with some moldy laboratory
materials and paper towels. In addition, medications should
always be discarded according to the manufacturer’s expiration date, even if
they’re not opened, as this is the final day that the manufacturer guarantees full
potency and safety of a medication. But we found 39 vials of expired medications
at Clinic A, some of them expired for years, though it was unclear how many
may have actually been in use. Before discussing the compounded
flush, I wanted to familiarize you with the standards applicable anywhere
sterile compounding is being done. The United States Pharmacopeia, or USP,
is a scientific nonprofit organization that sets standards for the
quality and purity of medicines. USP Chapter 797 sets practice
standards to help ensure that compounded sterile preparations
are high quality and safety, and these standards can help prevent
the harm that patients suffered as a result of contaminated preparations. Again all those that the standards in
USP 797 that I’ll discuss in the findings at Clinic A are highlights
rather than comprehensive. Some of the USP Chapter 797 standards for
sterile compounding address personnel training in aseptic manipulation skills,
stipulating the need that the personnel doing the
compounding have been trained by expert personnel and passed
a skills assessment. And there’s also standards for
labeling and storage of medications, handwashing, and the use of sterile gloves. And there are many standards for environmental
quality and control, including separation of the compounding area from any other
areas by a buffer or a clean room, routine environmental monitoring, such
as air particle and surface testing, and detailed procedures for cleaning
and sanitizing the compounding area. At Clinic A, compounding was performed by
a nurse who had no pharmaceutical training or performance assessment, and no pharmacist or pharmacy-trained staff
was providing supervision. There were no formal protocols
for compounding the flush, and these are the nurse’s handwritten
notes that she used for reference. Compounded bags of IV flush were also improperly
labeled, and then flush syringes were aliquoted over four to eight weeks
until the bag was depleted. And storage times for compounded medications
can vary depending on the medications used and the conditions under
which they are compounded, but prolonged storage time
will increase the potential for microbial growth in the
event of contamination. The flush was compounded underneath
the biological safety cabinet. Now this would be appropriate
for protecting personnel from hazardous medications being handled
and protect the product from contamination. However, the photo on the right
shows the contents of the area after the compounding process was demonstrated,
with potentially contaminated materials in the critical sterile area, such
as the outside plastic covering to the normal saline bag and
the use of nonsterile gloves. There should also be annual inspections
of the biological safety cabinet to ensure its meeting regulations, but the
last time it had been inspected at Clinic A was in 2014 when it was rejected for failure
to meet appropriate airflow patterns. The location of the biological
safety cabinet was also an issue. To the right is the photo I showed you earlier
of the infusion area, and on the left adjacent to the medication storage area is the
biological safety cabinet with no separation from the other areas of the clinic,
like the sink being very close nearby, and there was also no environmental
monitoring that was done or cleaning protocols for this area, which was just wiped down
at the end of the day with sani-wipes. So let’s discuss. There are a number of contributing
factors to this outbreak. One is substandard compounding
of the IV flush solution, which was the only common exposure
among all the case patients, and there was a dose/response relationship,
as increasing numbers of exposures to the flush was associated
with greater risk of infection. Bag number two was the most
likely bag that was contaminated, and whole genome sequencing was consistent
with the single point source for this outbreak. But unsafe injection practices and improper
medication storage were also issues, as the compounded flush bag was accessed
multiple times a day for many weeks and was stored in an unlabeled refrigerator
that was not exclusive for medication storage, all of these leading to opportunities
for contamination. More importantly, though, was a
lack of awareness and adherence to basic infection control and prevention
practices, which led to a failure to meet minimum safety standards for
infection control and patient safety. There was also a failure to be aware of and meet
standards for compounding of sterile medications as well as a lack of oversight and
enforcement of these standards. So we recommended an infection control
training for clinic staff and an assessment of the oncology practice by an infection
control professional who could assist with ongoing remediation efforts. And it was paramount that Clinic A
become compliant with CDC’s guidance for infection prevention and control
and to either apply the safe, sterile compounding standards outlined by
USP 797 or to cease further compounding and utilize a specialized
compounding pharmacy if needed. During the investigation on May
31st, a commissioner’s order to cease and desist practices at Clinic A was sent to the
provider by the New York City Health Department, and this was amended on June
22nd with specific expectations of clinic practices before medication
preparation or delivery could resume. On October 5th, the order was lifted after the clinic had undergone
extensive remediation guided by a consulting infection control
practitioner and pharmacist. It was also necessary that the
clinic demonstrate the ability to safely prepare and deliver medications. However, medication compounding is
no longer occurring at the clinic. But unfortunately, these types of outbreaks are
not uncommon to outpatient oncology clinics, and this is in fact just the latest in a series
of outbreaks we’ve assisted with investigating. And the two shown here were associated
with poor injection safety practices and improper medication preparation,
respectively. However, while oncology clinics serve a
vulnerable patient population and have a scope of medical practice that usually includes the
prescribing and delivery of IV medications, issues of poor infection control and medication
safety are not unique to oncology clinics. Challenges exist across many outpatient
healthcare settings, such as pain management and orthopedic clinics, where
injections often occur. There are likely more outpatient
facilities performing similar medication and injection services. So what is it about outpatient clinics
that makes their practices concerning? First, few outpatient healthcare
facilities are licensed or accredited. And as a result, many facilities are
opened and operated without being able — without being held to minimum safety
standards for infection control or other aspects of patient care. Outpatient facilities can
also offer invasive procedures without being subject to onsite inspections. And there’s no clearly established authority
for monitoring adherence to infection control and sterile compounding standards
in these settings. For example, many state boards of pharmacy
only have authority to regulate compounding by pharmacies and pharmacists, rather than
compounding at a clinic by a nurse or physician. And while the FDA has the authority to enforce
applicable federal law over compounding, states maintain primary jurisdiction
in these settings. There is often a lack of infrastructure
and resources to support infection control in sterile compounding, and the latter may be
conducted in the absence of pharmacy controls. Personnel are often inadequately trained
with continuing education requirements and other training varying greatly amongst
states and other healthcare professionals. Providers may be unaware that
their practices are crossing over into complex medication
preparation that is subject to federal and state sterile compounding
laws and standards. And there are highly variable
requirements for monitoring and reporting of HAIs and other adverse events. This can lead to delayed identification and
response to outbreaks, which are often reported by someone other than the practice
provider, such as a laboratory or an astute physician at a hospital. Such was the case in this outbreak. So there’s been a tremendous investment
by CDC to address these issues. In October of last year, CDC released
the outpatient settings policy options for improving infection prevention, which
outlines possible effective strategies to improve oversight of outpatient settings. This document focuses on four keys elements,
facility licensing and accreditation, provider level training, licensing and
certification, reporting requirements for HAIs, and effective application of
investigative authorities. CDC continues to partner with state, local, and
territorial health departments to identify gaps in oversight and enforcement of standards
and are involving medical specialty boards and professional organizations
to help raise awareness. So to summarize, this was an outbreak
of 17 cases of Exophiola dermatitidis or Rhodoturula mucilaginosa
bloodstream infections associated with a single oncology clinic and provider. Multiple lapses in infection control and
prevention practices were noted at the clinic as well as substandard sterile
compounding, storage and handling of an IV flush solution,
which was the likely source. And finally in conclusion, oversight
of infection control practices and medication compounding in
outpatient oncology settings is an issue of great public health importance
and is probably occurring with greater frequency than we are aware. This is especially disconcerting since oncology
clinics serve a vulnerable patient population, and we’re working with public health partners
to close the gap in awareness and enforcement of infection control and compounding
sterile standards in outpatient settings. And I just want to quickly thank the many
people who were critical to the investigation, especially those at the New York City
and New York State Health Departments and the Mycotic Diseases Branch here at
the CDC for helping lead the investigation. Thanks.>>Thank you, Dr. Vasquez. It might not have been clear to the
audience, but you served as a part of the investigation team in what capacity?>>Yeah. I was the lead EIS — EIS officer. So I led the field team as we, you know,
did our epidemiologic investigation, infection control assessments,
and made our recommendations.>>Okay. Well, thank you again for a really
excellent summary of a complex investigation, a very unfortunate outbreak, as you pointed out. This harm was preventable. We’ll turn next to the lead of the New York
City component of the investigation team, Dr. Acklesberg, for further comment.>>Okay. Thank you, Dr. Perz. My presentation is titled “The Wild, Wild
West: Public Health Options to Expand Oversight of Outpatient Oncology Practices. And I think — are you hearing
some feedback there?>>Unfortunately, yes.>>Okay. Let me see if I can address that.>>Yeah, feel free to take a moment.>>How’s that?>>Much better.>>Okay, great.>>Thank you.>>All right, well, the Wild, Wild West
was a term used multiple times during this investigation to describe the likely ground
truth practice reality throughout the outpatient oncology terrain. Over the past ten years, public health
agencies have become increasingly familiar with the risks emanating
from compounding pharmacies. However, compounding pharmacies like the
New England Compounding Center are fairly recent phenomena. Before getting into the federal and
state regulatory issues that we will look at in a few minutes, it’s worthwhile
to very briefly review some of the underlying circumstances
that led to the emergence of these medication preparation entities. Next slide please. Just — you can just go through these quickly,
quickly, the next one, next slide please. Thanks. For the first half of the 20th century,
community pharmacists often prepared medications from components kept in their establishments. Physicians would order medications,
and pharmacists would prepare them by mixing components, that is compounding
medications — next slide, please — before dispensing them to individual patients. It is estimated that in the 1930s and 1940s, approximately 6% of the medications
dispensed by pharmacists was compounded. In 2006, it was estimated that fewer than 1% of community pharmacies did
any medication compounding. Next slide, please. I wanted to note here much of the
material in this next set of slides comes from an excellent historical review by
Charles Meyers that was published in 2013 by the American Journal of
Health Systems Pharmacy. Hospital pharmacies in the first decades of the 20th century were
similar to community pharmacies. Medications for patients often
were individually compounded by a pharmacist in the hospital dispensary. Into the 1950s, large volume sterile IV
solutions, which could include medications, and sterile irrigation solutions were compounded
in central sterile surface departments. Vitamins and minerals were
added on nursing stations for individual patients as deemed necessary. By the 1960s, because of growing
concerns about drug safety, this admixture function slowly
shifted to hospital pharmacies. This was the time when the field of
clinical pharmacy began to flourish. In the 1970s, new IV delivery systems,
including piggybacking of medications, enhanced the flexibility of parenteral
and medication of the administration. With the advent of individualized
chemotherapeutic regimens of the 1980s, medication admixture became
centralized in hospital pharmacies. The invent — the invention of the
laminar flow hood of the 1960s, and then the biological safety cabinet were
major advances in medication preparation safety. These technical advances also had
the impact of increasing the use of a centralized hospital pharmacy for
medication preparation and admixture. With the advent of total parenteral nutrition
in the 1970s and then cardioplegia in the 1980s, extremely complex procedures for compounding
sterile preparations became necessary at hospital pharmacies. But technologic improvements such
as automated medication compounding and medical reimbursement pressures led to hospitals identifying new
approaches for treating patients. More and more patients have
procedures and surgery conducted in pre-standing ambulatory care settings
and patient had home infusion of medications that had previously been
administered in hospitals, demonstrating that medication compounding
could be done outside of the hospital setting. Next slide, please. Next slide. By 2001, shortages of drugs manufactured by generic manufacturers became
frequent and long-lasting. The Medicare Prescription Drug
Improvement Monetarization Act of 2003 may have produced profit margins — may have reduced profit margins
for drug manufacturers, causing some of them to drop
out of the marketplace. By 2012, injection drug shortages
were commonplace. Compounding pharmacies became a more
frequent source for injected medications. It was during this period that outbreaks
were periodically linked to contamination of parenteral medications
in compounding pharmacies. It took some time before regulatory authorities
were given the tools to put into place standards for sterile medication compounding
that facilities of all sizes should be expected to follow. US Pharmacopeia Chapter 797 for compounding
sterile preparations was published in 2004, and this was followed by Chapter 800, handling
of hazardous drugs in healthcare settings, which is scheduled to be implemented
in 2018 and is particularly germane for outpatient oncology settings. The Food, Drug, and Cosmetic Act, first
passed in 1938, was periodically amended to address the changing medication
preparation terrain. It was most recently changed in 2013 in response
to the fungal meningitis outbreak caused by the New England Compounding Center. Note that the relevant language in the
act covers both pharmacists and physicians who engage in compounding
medications and that they are mandated to follow US Pharmacopeia standards. The Food, Drug, and Cosmetic
Act — next slide, please — sets the legal safety standards
that drug manufacturers must follow. It also provides the Food and
Drug Administration, or the FDA, with the legal authority to
inspect drug manufacturers. This now includes outsourcing facilities, a
new designation for compounding pharmacies that was included in the
2013 amendment to the act. Importantly, outsourcing facilities
are now required to follow current, good manufacturing practices that drug
manufacturers are required to use. State boards of pharmacy are charged
with enforcing the drug safety provisions of the Food, Drug, and Cosmetic
Act in their local jurisdictions. Most of the outbreaks involving sterile
drug preparation and certainly those that have caused the most public health
impacts and professional concern — next slide, please — have involved breaks
in asepsis within compounding pharmacies. Next slide, please. Moreover, the federal and state laws
and regulations that have evolved over time have been directed largely at
hospital pharmacies and compounding pharmacies that conduct business that more
resembles drug manufacturing than hospital-based clinical pharmacy. However, this outbreak of fungal bloodstream
infections was caused by improper preparation of compounded sterile preparations in an
outpatient oncologist’s private office. An IV flush solution that was
stored in a refrigerator for up to two months was improperly prepared
in a biological safety cabinet. That was last tested and failed inspection
in 2014 in which was situated next to a refrigerator and in which
improper technique was used to prepare parenteral medications. The refrigerator contained chemotherapeutics
that had expired years beforehand, loose needles, and unsecured narcotics. Multiple partially used IV
bags were also found on shelves with their administration set still attached. The New York State Board of Pharmacies’
contention during the management of this outbreak was that the
oncologist’s pharmacy practices fell outside of their jurisdiction. After speaking with the New York State
Department of Health, which has an office that addresses clinical misconduct, it became
clear that there was considerable regulatory gap in regard to pharmacy-related and
infection prevention practices by outpatient physicians,
specifically oncologists. They could rescind the provider’s license
if an investigation uncovered malfeasance, but there was no ongoing oversight of outpatient
provider settings other than a requirement for them to take an online infection
control course every four years. The New York State Department of Health
regulates hospitals, nursing homes, diagnostic and treatment centers, such as dialysis
services, and large outpatient clinics. They do not regulate solo practices
and other small outpatient settings. By default, most outpatient
physicians’ offices fall under the purview of local health departments. But the New York City health code doesn’t
authorize New York City health code — New York City Health Department to regulate
physicians not regulated by the state. However, the health department does
have broad powers that include abatement of public nuisances, which was the basis
of the commissioner’s order that shut down the oncology practice, pending sufficient
remediation of the problems that were identified by investigations — investigators from
CDC, the New York City Health Department, and the New York State Department of Health. I’ve never heard the word “egregious”
used so many times by so many people to describe the conditions
found in this provider’s office. In a highly unusual move, inspectors from the
FDA’s district office spent two days looking into the medication preparation and administration practices
in the oncologist’s office. This actually begged the question. Was this an anomaly, or the chance detection by
an astute ICU clinician of a more common event that typically flies under
the public health radar? Dr. Vasquez already noted that the 2011 to 2012
outbreak of Tsukamurella bloodstream infections in another outpatient oncologist’s
office that also was caused by improper preparation of IV flushes. Is it the Wild, Wild West out there in regard to
outpatient oncology practice with a significant but undetermined public health burden? Ideally, to answer this question, we would
need to identify the universe of solo practice like New York City oncologists who
do not practice under the aegis of an academic medical center or hospital and
their distribution across the Five Burroughs. An oncology colleague suggested to us a strategy for characterizing this terrain
that we have started to explore. The Centers for Medicare and Medicaid Services
publishes Medicare provider utilization and payment public use files, or PUF
files, that are available publicly. The data contain all requests by providers for
reimbursement from Medicare Fee for Service, for clinical services and medical
products dispensed to patients. The data are aggregated by provider in that
the total number of reimbursement requests for particular services and products
are listed in each provider record, which also includes the mailing address of the
provider, by filtering for chemotherapeutics and services used by oncologists by providers
who self-identify as oncologists and by those who practice in small outpatient settings that are not associated with
academic medical centers. We can arrive at a rough estimate
of the universe and distribution of the independent outpatient
oncologists of interest. Once we have the information just described,
we will be able to devise a sampling strategy to survey outpatient oncologists by phone
and to directly observe a subset of them. In this way, we can determine how wildly
wild and egregious it truly is out there. With those data, we will be in a stronger
position to consider regulatory options with the New York State Department of
Health, such as requiring a separate level of accreditation of outpatient oncologists,
as is currently required of providers who conduct office-based surgery. Professional organizations
such as the American Society of Clinical oncologists also
might consider enhancement of the professional standards expected
in these outpatient oncology settings. We have scheduled ongoing discussions with
New York State to explore these options. Thank you. Thank you very much, Dr. Acklesberg. Personally, I’d like to commend you
and your team not only for organizing and managing this investigation,
but for looking farther upstream and helping us understand better the
regulatory landscape and the conditions that might have been concerted or overly
permissive in this case as far as resulting in the risks to patients that Dr.
Vasquez described in her presentation. With that, we’ll turn to Dr. Lisa Richardson.>>Thank you, Dr. Perz. And thank you, Dr. Vasquez and
Acklesberg, for your presentations. As co-lead of CDC’s Preventing Cancer
Infections in Cancer Patients Program, I’d like to add some further
evidence we have found as to why this is a growing
public health concern. As providers, I know you
understand the risk associated with cancer and chemotherapy treatment. Each year, 660,000 cancer patients receive
outpatient chemotherapy, which puts them at risk for one of the deadliest side effects of
chemotherapy, neutropenia, or low white count. Sixty thousand cancer patients are hospitalized
for chemotherapy-induced neutropenia and infections, and one patient dies
every two hours from this complication. They may not be aware of their risk
for developing a low white count and actions they can take to
lower their risk of infection. As Dr. Vasquez and Acklesberg talked about, some outpatient oncology facilities lack written
information on infection control and prevention and are not routinely inspected or
routine — inspected at all really. Likewise, patients may be overwhelmed with
the amount of information they are bombarded with at the time of cancer diagnosis,
making it almost impossible for patients to remember all the information they receive. Together, these two factors can
contribute to unnecessary infections. For this reason, the CDC developed
the Preventing Cancer Infections in Cancer Patients Program to raise
awareness among patients, caregivers, and healthcare providers
about steps they can take to prevent infections during
cancer chemotherapy. To meet this objective, several strategies
were implemented, including developing improved and consistent infection control information
for outpatient oncology providers, as we heard, and creating user-friendly resources to
help patients better understand their risk of developing neutropenia and
infections during treatment. As mentioned in Dr. Vasquez’s presentation, CDC
developed or created the basic infection control and prevention plan for outpatient
oncology settings. The plan was created to standardize and
improve infection prevention practices, by providing essential elements to meet
minimal expectations of patient safety which are all based on guidelines
from CDC and professional societies. The plan is broken down into
several main sections. The first section I’d like to
mention is on education and training. It encourages ongoing education and training of
clinic staff, to maintain competency and ensure that infection prevention policies and
procedures are understood and followed. This should be done at orientation, and repeated
at least annually, and any time policies or procedures are updated,
or new staff are hired. Regular audits should also be performed
to ensure staff adherence and competency in infection prevention practices such as
proper hand hygiene, and environmental cleaning. The second important component deals
with surveillance and reporting. Routine performance of surveillance
activities is important to case findings, outbreak detections, and quality
improvement, and health care practices. All facilities should conduct surveillance
for healthcare-associated infections such as central line associated bloodstream
infections, and process measures, such as proper hand hygiene technique. And all staff should adhere to local state, and
federal requirements for outbreak reporting. The third component covers standard precautions. These are a set of infection control practices,
used to prevent transmission of diseases that can be acquired by contact with
blood, body fluids, non-contact — non-intact skin including
rashes, and mucous membranes. These are the basic infection control
precautions which are to be used, at a minimum, in the care of all patients. Not just oncology patients. The next section covers transmissent —
sorry, transmission based precautions, which are implemented in special situations. You should use contact precautions
when you have a case of known, or suspected infectious diarrhea, draining
wounds, skin lesions, droplet precautions when you have a patient with a potential
or confirmed respiratory infections, and airborne precautions for patients known
or suspected to be infected with a pathogen that can be transmitted by the airborne-route
such as tuberculosis, chicken pox, or measles. And the last section pertains
to access and maintenance of long-term central venous catheters. This plan recommends practices for
general maintenance and access procedures, which include the use of aseptic technique
for accessing central venous catheters, blood draws from catheters,
proper flushing techniques, and changing catheter site
dressings and injection cap. The plan also outlines catheter-specific
recommendations for peripherally inserted, central catheters, tunneled
catheters, and implanted ports. The plan also includes additional resources,
appendix A is meant to be completed and tailored to any facility that would like to have one
document that lists the person responsible for implementing the plan,
as well as their roles and responsibilities in infection prevention. As we saw from the presentation
by Dr. Vasquez and Acklesberg, most places do not have an infection
prevention checklist in their setting, and as Dr. Acklesberg said, this is not
unique to outpatient oncology settings, this is all ambulatory settings, I believe. The checklist should be used to ensure that your facility has appropriate infection
prevention policies and procedures in place, as well as the proper supplies for
staff to implement these policies. It can also be used to assess
personnel adherence to standardized infection prevention
practices, such as hand washing. And lastly, the final appendix
is a list of additional resources and links to national guidelines. My hope for all of you listening today, is that if your clinic doesn’t have
an infection control plan in place, that you start using the plan
and further supplement as needed. If your facility has an existing protocol,
you can use the plan as a guide to ensure that the essential elements are included. I’d like to spend the last few minutes talking
about how we achieved our second strategy of creating user-friendly resources to
help your patients understand their risk of developing a low white blood cell count,
how to understand the signs and symptoms of a possible infection, and what they can do
to lower their risk of getting an infection. The website includes a suite of
educational fact sheets, posters, blogs, and more on
http://www.preventcancerinfections.org/. Users have two options, they may complete
a brief risk assessment questionnaire, and receive tailored information — sorry,
information — infection control messages, based on their risk for a low white count,
or users can simply explore the website and download materials as they wish. So if you scroll down past
the risk level message, you will see a grid of health tip sheets. Topics include, how to care for your
catheter, food and kitchen safety, signs and symptoms of infection, and more. One thing we heard from our focus
groups in our early development stage, was not everyone would utilize
the risk assessment questionnaire, some would just be able to access
information without answering any questions. For this reason the website also
includes a resource page where educational and other resources can be downloaded. Thank you for your time today, and now
I’d like to turn it back over to Dr. Perz.>>Thank you very much, Dr. Richardson. Yes, I think we’re reminded that while unsafe
medication preparation practices may very well be occurring with perhaps even
increasing frequency in a wide variety of outpatient settings, that cancer
patients are especially vulnerable. I think that, you know, this really
is an example for us to take to heart. Because, you know, I can’t think of a patient
population, you know, for whom, you know, our obligation to provide safe care
could be any greater, you know. This is a patient population that’s,
you know, seeking to improve, or at least preserve its
health, and to suffer setbacks because of preventable infection
risks is really a tragedy. We are going to transition
now to the Q and A section. I want to remind folks that they can
submit their questions, you know, through the web, the webinar interface. There were a few questions that came in, so I’ll be trying to address those
with the help of our presenters. But first I had a question having to do
with outbreak detection and reporting. Dr. Richardson mentioned in her presentation
that the materials that CDC has developed and made available include guidance on
monitoring for infections and reminders about the obligation to report
potential outbreaks. I wondered if Dr. Acklesberg, or perhaps
Dr. Vasquez could speak a little bit about how this outbreak in New York City
came to light, and perhaps any sense of whether this is just the tip of the iceberg. Dr. Acklesberg, would you like to go first?>>Sure. That really is the main question. And it’s, you know, to the
end of answering that question that we’re doing what I just briefly
described at the end of the presentation. One thing, you know, it’s unclear to what
extent the comprehensive practice guidelines that have been developed by CDC have
actually penetrated into the ongoing practice of ambulatory care medicine in general and in
the oncology community, you know, specifically. I can tell you that this practice, in this practice there certainly was not a
systematic method of surveilling for bloodstream or other infections, as Dr. Vasquez mentioned,
there was no written practice protocol that included procedures to notify local public
health when clusters of illness were detected, as required by the New York City health code. So it’s quite possible that this is, you
know, a fairly common situation in, you know, all outpatient settings, let
alone in oncology practices. We heard about this outbreak because it
was noticed in an ICU where two patients from the same provider were hospitalized
in, you know, at the same time. So you know, it was good
fortune that we heard about it. It was also good fortune I
think that a more virulent and pathogenic mold wasn’t
involved in this outbreak. So I think it’s really a cautionary tale
that is probably more of this going on, or at least the potential for it that
needs to be looked at as possible in cities and state public health jurisdictions.>>Yeah thank you very much for
those, for making those points. Yeah again, a reminder that outbreak
detection is currently really quite haphazard, and as you put it, we were
fortunate that this was detected and reported apparently somewhat early. So that leads to a question for Dr. Vasquez. Can you talk about the decision regarding
advising removal of catheters and any sense of what effect that had in terms
of the burden of illness here?>>Yeah absolutely, one of the remarkable things
about this outbreak that I didn’t get to touch on in the presentation, is the
fact that it was found early. Even if it was somewhat lucky, you know,
that there was a report from an ID physician to the health department that
prompted the investigation. Our active case findings through surveillance
blood cultures identified 12 patients who were very vulnerable. They were undergoing chemotherapy,
they were immuno-suppressed, and they could have suffered
much more dire complications. But in fact, they never even had symptoms. So we identified them early but a
handful of them, two or three of them, were actually identified because we
took out their central venous catheter, even though we’d done a blood
culture and it was negative. So it sort of happened at that
point in the investigation that we were already pretty confident that
we had found the likely source of this, and we consulted with some experts
at local academic institutions and the New York City Health Department, as well
as the experts at the Mycotic Diseases Branch to sort of come up with treatment
recommendations to guide Hospital-A in helping to manage these patients. I mean Hospital-A really shouldered a
large burden of caring for these patients as we identified them and had them go in
for cultures, had their CVC’s removed, have them seen by an infectious disease
physician to start fungal therapy, even if they weren’t having symptoms, and in fact many of those patients
were identified via that method.>>Thank you.>>Dr. Perz –>>If I can just add to that,
Dr. Perz just for a second.>>Sure.>>I would just, I would just like to underscore that Hospital-A really just performed
heroically in this outbreak, you know. We see that often here, in the Big Apple. But they were asked to do a lot,
and they shouldered a heavy burden, and we’re very grateful for the efforts of
that particular health care institution.>>Yeah, thank you for highlighting that –>>Dr. Perz, this is Dr. Richardson, yeah.>>it’s really essential that in these
situations that we get good cooperation between our health care, our health
care partners and public health. Lisa, was that you adding a comment?>>Yeah it was, I just wanted to make a
comment about the central venous catheters. I’m an oncologist by training, and I think other
physicians as well that we’ve become complacent when these devices are in place, and we
forget that these are foreign bodies, and that if there are issues
or problems that, you know, the more conservative thing you can do is
to remove them regardless of what, you know, what the problem is or what the organism is. Because it’s still going to be
there, and it’s very difficult to treat a foreign body like
that while it’s still in.>>Thank you very much. There’s a question which came in Lisa, which
I don’t know if you’ll be able to help address or not, but let’s have a go at it. Well actually, while I’m trying to locate
that one, here’s one that’s jumping out at me and it has to do with outside of the, the
hoods that were being used for med-prep in this clinic, considering the more general
patient care environment were there other concerns in terms of cleanliness,
areas of contamination?>>Right yeah, thank you for asking that
question, because it’s absolutely critical. We did evaluate, you know, the
environment, not just inside the clinic but in the hallways outside the
clinic, in the areas out on the street, and it’s almost a given, maybe not
in outstanding clinics but certainly in hospitals these days, you
hear about construction going on. There was some, sort of adjacent
to the building. But not really in direct
communication to the clinic. There wasn’t a window nearby or anything. And so there wasn’t something that was sort of directly communicating
with the outside environment. There was a back door that went
to a hallway that, you know, you wouldn’t want to eat
off the floor or anything. I mean it was a hallway that lead
to, you know, an apartment complex and it was cement floor, et cetera. So but nevertheless we sampled
quite a bit of the environment, and as you might expect there
was some organisms that we found. I mean it’s not completely sterile
in any outpatient clinic like this, so unfortunately we just didn’t find any
Exophiola or Rhodoturula, but in any — as patients are coming back to that
area, I mean this was not a clean, sterile area where these
medications were being prepared. Patients were coming through, and they’re coming in in their street clothes,
and shoes, et cetera. And even if you’re just, you know, you know
cleaning the floors on a regular basis, there’s still — you’re directly
communicating medication-preparation with where there’s high traffic,
and patients are being cared for. So there’s still going to be opportunity
for contamination of medications.>>Okay, thank you for that. Yeah, I’m realizing that we’re coming up on
time, we unfortunately won’t be able to get to every question that’s been submitted. As part of the follow up, you know,
the slides and additional information, archiving this presentation will be presented, or placed on the CDC website
to the extent possible. We’ll try to summarize some of the
additional questions, and provide responses. One question — a couple of the
questions are getting at standards. For example, construction standards
for outpatient clinics of this type. I know that the, you know, the Facility
Guidelines Institute is a cross-cutting body that includes input from
infection preventionists, but more so from health care
architects and others. I think, you know, clearly more attention to
thoughtful, purposeful design of these types of facilities is something that’s required. There’s a question here about does CMS, the
Centers for Medicaid and Medicare Services, have rules in place for following USP 797 and other relevant standards
in these private clinics? Lisa jump in if you know
more about that than I do. My sense is that that’s probably a
policy lever that could be explored. Medicare of course is paying for
a lot of outpatient cancer care, and whereas on the inpatient side, or other
facility types like dialysis, nursing homes, there’s a lot of attention to
CMS conditions for participation that spell out infection control standards. I don’t think that’s the case for
independent, outpatient oncology.>>I think you’re right, Joe. That does not currently exist. But you know, the hopeful sign that I heard, and
Dr. Acklesberg’s presentation is that, you know, CMS may get involved in New York City. And it is a great lever, because they pay
for most of the cancer care in this country. So that would be a way to go
as a policy lever, definitely.>>Okay thank you. We’ve come up, almost on the end of time, and to
make this official we need to review information for our participants to obtain
their continuing education credits. So you should be seeing a slide
onscreen, I’ll just summarize that to receive your educational credit
you need to pass the post-test activity. You need to get a 66% minimum score for that. When you close out of the webinar,
a post-meeting web page will appear. That will have detailed instructions about
completing the post-test and evaluation. For folks who are perhaps
listening on the phone, but aren’t logged into Ready Talk please
go to http://www.CDC.gov/tceonline, the access code for the webinar is “WC0418”. Again, a follow up email will be sent out later
this afternoon with more detailed instructions. So everybody who’s registered should
have access to those instructions. And with that, as the clock strikes
three o’ clock eastern here in Atlanta, I’d like to thank all of our speakers
as well as all of you who tuned in today for taking the time, and for your
commitment to keeping patients safe. Thank you very much.

2 Comments

  • Reply Cynthia Reyes August 2, 2017 at 3:32 am

    how can a regular person report an outbreak

  • Reply Fufa Hunduma November 30, 2018 at 12:37 pm

    the sound is poor

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