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fraserhealth

Better health.

Best in health care.

January 9t", 2011

Executive Summary: Clinically unacceptable rates of nosocomial

Clostridium difficile infection at Burnaby Hospital,

There is a significant, serious and sustained problem with nosocomial CDAD rates at Burnaby Hospital, which exceeds regional, provincial and national averages. This has.resulted in significant morbidity and mortality.

There are significant problems with the organization, integration and management of local and regional administrative structures of infection control in the Fraser Health Authority.

Correcting these problems will not only improve patient safety, but address the Fraser Health Authority's own quality initiatives of increased efficiency and cost

effectiveness, such as the "350 Challenge".

Summary recommendations based on discussions with medical staff and the Infection Control Committee include:

At the

local level of Burnaby Hospital:

II Immediate institution of enhanced cleaning of hospital units showing high endemic rates of CDAD until further notice.

• Review of the adequacy of local Infection Control Practitioner and unit nursing staffing levels.

• Renewal of funding for the role of"lCP Champion".

• Review and coordination of staffing and funding levels for medical epidemiology, internal medicine, infectious disease, medical microbiology and pharmacy services as they pertain to stewardship of antibiotic and PPI usage and support of best medical practices

for infection control practitioners.

• Immediate and personal responsibility of the local Site Director in

coordinating these activities and ensuring their effectiveness.

• Establishment of specific timelines for review of the implementation of these changes, review of their effectiveness and institution of

further changes as required. • Aggressive implementation of the recommendations of Dr. Michael Gardam as to CDAD control measures, once the final report is available.

Burnaby Hospital

Fraser Health Authority

3935 Ktncaid Street Burnaby BC

VSG 2X6 Canada

At the regional level of the Fraser Health Authority:

Review of the contractual definition as to-the roles of the Medical

Director of Infection Control and the adequacy of the current FTE funding for that duty.

• Review of the integration, reporting, authority and responsibility of infection control management between the local and regional levels of the Fraser Health Authority.

• Resolution of the responsibility of the vadous arms of the Fraser

Health Authority Executive for management and funding of on-call

coverage of infection control services.

• Establishment of an authoritative regional triage system to control

CDAD and other infection control outbreaks, as per.the Ontario

model.

• Review of the currently used laboratory methodology for CDAD

detection in the Fraser Health Authority.

• Review of the adequacy of current Infection Control Practitioner

staffing at the various medical facilities within the Health Authority.

• Review of the adequacy of currently existing contracts for hospital

cleaning operations.

• Establishment of specific timelines for review of the implementation

of these changes, review of their effectiveness and institution of further changes as required.

• Aggressive implementation of the recommendations of Dr. Michael

Gardam as to CDAD control measures, once the final report is available.

fraserheaith

Beffer healfh. Best in health care,

Dr. Nigel Murray, CEO, Fraser Health Authority

Dear Nigei,

January 9th, 2012

We are writing to you as rePresentatives of the Burnaby Hospital Infection

Control Committee and concerned medical staff to ensure your awareness of the

scope of the continuing issues in regards to Clostridium difficile associated diarrhea (CDAD) management impacting Burnaby Hospital.

The sustained endemic rates of CDAD at Burnaby Hospital have ranged between

~ 2 to 3 times the national and provincial averages for more than the last two yÿ,ÿrÿ--(mean 1.95 cases per t000 patient days; national/provincial average estimate 0.8 cases per 1000 patient days). These rates are reminiscent of the

CDAD issues impacting Nanaimo General Hospital in 2008 (see appended document), which prompted external review by the BC Center for Disease

Control (BCCDC). They are also equivalent to the rates of CDAD in the hospitals

of the Niagara Region, which resulted in subsequent media frenzy and

governmental led reviews and changes in CDAD reporting and management in Ontario.

To give you a sense of raw numbers, epidemiologic infection and prevention control data i requested compiled this past December show that over the period

of the last two and a half years (2009 to mid-2011ÿ&tBurnaby Hospital alone

within the Fraser Health Authority, there have beenj47ÿerio#s cases of CDAD

colitis, of which there were 7 resulting total colectÿmies and!ÿ}4ÿ-pÿtiÿnt-iJeÿhÿs °-°ÿ (Appendix 1). This data doÿh-6t-iSÿliJÿthÿTÿitÿtÿ]5ÿatr6nt'ddhhb-ers relÿ,tirig t-6

the two subsequent CDAD outbreaks at Burnaby Hospital, which prompted unprecedented unit closures in late 2011. I assure you, these latter numbers will be high.

This mortality statistic recorded by the Fraser Health Authority is patient death within 30 days of a positive C. difficile test. Of course, this raises the question as to how many of these deaths are directly attributable rather than simply associated with CDAD colitis, it would be of interest to you that Dr. Michael Gardam, an internationally recognized authority on CDAD infection control

management, was recently invited to perform an impromptu review of infection control management at Burnaby and Royal Columbian Hospitals in November

2011. He has recently published an article currently in press which directly

addresses this issue. Retrospective review of this 30-day mortality statistic, also

recorded in Ontario hospital CDAD outbreaks, demonstrated 80% of these

Burnaby Hospital

Fraser Health Authority

3935 Kincaid Street

Burnaby BC VSG 2X6 Canada

deaths were directly attributable to the complications of CDAD colitis (Hota et al.,

in press).

The etiology of this problem at Burnaby Hospital is multifactorial, and includes:

• Infrastructure

• Aged hospital infrastructure, with insufficient numbers and

inadequate localization of sinks.

• Patient volume and demographics

• Hospital overcrowding, consistently above census.

,, The busiest emergency department in the province.

• A predisposed and susceptible elderly patient population. • Medical Management

• Lack of coordinated management with internal medicine and

pharmacy as to stewardship of antibiotic and proton pump inhibitor

usage.

• Infection control measures

• Inadequacy of hospital maintenance and cleaning.

• Inadequacy of infection control practitioner and nursing staffing. • Lack of administrative organization, emphasis or support for excellence in infection control management.

Some of these issues, such as facility infrastructure problems, are difficult and excessively costly to rectify. There is little that can be done on a local facility basis to control patient numbers or their predisposition to acquiring CDAD colitis. However, under medical management and infection control measures, there is a

significant gap in both local and regional administrative support and resources in Burnaby Hospital and the Fraser Health Authority. This is a problem that can be

rapidly corrected, should the Executive decision be made to do so.

Part of this problem relates to changes resulting from implementation of

"Regional Program Management". As you are aware, this eliminated the

positions of local Medical Directors, replacing them by non-clinician

administrative Site Directors. This was ostensibly a cost savings measure. The

local Medical Director was typically an experienced physician with intimate

knowledge of both local medical staff and local facility issues and represented the mechanism by which local hospital medical issues may be resolved.

In the absence of a Medical Director, this responsibility has fallen to the Site

Director. I make note of the fact that our local Site Director has been absent for

all of the Burnaby Hospital Infection Control Committee meetings of 2011,

including the emergency meetings convened to manage the unprecedented

CDAD outbreaks and resulting unit closures in the latter half of the year. There has also been no senior administrative representation to the Burnaby Hospital Infection Control Committee, despite the very active and public PR role that Dr.

Andrew Webb assumed in response to the interest some Burnaby Hospital

physicians expressed in regards to "fecal transplantation" in treatment of

intractable CDAD colitis earlier in 20111

Indeed, we are informed that technically the local Infection Control Committee no longer exists under Program Management as, under this system, it has no formal integration or reporting structure within the Fraser Health Authority. As a result, the Committee has been reduced to a role of documenting problems, with no mechanism to report or address such issues to any authority. Should you wish,

the Bumaby Hospital Infection Control Committee is prepared to cease its

activities and dissolve the Committee.

We would also like to point out the minimization of the scope of the Burnaby

Hospital CDAD problem by our local Site. Director, which illustrates the lack of emphasis on improved and sustained infection control measures. In the meeting February 1st, 2011 between the Site Director, local infection control practitioners and myself convened to address concern in regards to the excessive rates of CDAD, our Site Director expressed the opinion that "the problem is getting better"

an opinion also recorded in the minutes of the Burnaby Hospital Multidisciplinary Healthcare Coordination Committee (MHCC) in the spring of last year. We note that as of December 2011 our local Site Director has moved on to a different role within the Fraser Health Authority. One would hope that the role of Site Director will not become a revolving door, as it is difficult to envision how this will lead to quality management; this CDAD issue a case in point.

As we hope you are aware, shortly thereafter were two subsequent and locally

unprecedented outbreaks of CDAD colitis at Bumaby Hospital in the latter half of 2011, both resulting in prolonged unit closures:

• Unit 3D: 9 days of unit closure, July 21st- July 29th, 2011. ° Unit 5A: 12 days of unit closure, Nov. 21st- Dec. 2nd, 2011.

As you would expect, this had significant impact on hospital operations. Such was the concern in regards to patient care and overflow within the ED, the question was raised at the last meeting of the Infection Control Committee

November 30th, 2011 whether the ED could overturn unit closure recommendations out of medical necessity.

It has been the practice of infection control management that individual patient admission to a closed unit will be considered based on medical necessity on a

case-by-case basis. However, should the need arise to open entire closed units to admissions, both Dr. Fred Roberts and I are in agreement that such decision

should only be undertaken by the highest executive within the Fraser Health

Authority. Consequently, the ED has been directed to address personal

1. For the record, both Dr. Fred Roberts and I are in agreement with Dr. Webb that "fecal transplantation" is a poor idea at Burnaby Hospital for a multitude of reasons, which has been documented in the minutes of the Infection Control Committee.

responsibility for such decision in any future circumstances specifically to yourself or to Dr. Andrew Webb.

However, Program Management only represents part of the lack of coordinated

or organized administrative management of infection control in this Health Authority at either the local or regional level. Other notable examples including:

The fact that the Fraser Health Authority relies on Dr. Fred Roberts, the Regional Medical Director of Infection Control to manage on a part time 0.7 FTE basis, a health care operation roughly the size of Belgium.

The fact that Dr. Fred Roberts has indicated he would prefer to step down from this role in 2012 rather than accept the currently proposed contractual roles of Regional Medical Director of Infection Control. The fact that the Fraser Health Authority has yet to identify any successor for the role of Regional Medical Director of Infection Control, should that

take place.

That specific request at Burnaby Hospital for enhanced cleaning of high CDAD rate medical units, made at the behest of the Infection Control Committee to manage the latest outbreak in November 2011 has still not

been implemented over a month later. That temporary one-year funding from local administration for the unit

educational role of "C. difficile Infection (CDI) Champion" has been

allowed to lapse, despite the current environment.

That those individuals who have been in the rote of "C. difficile Infection

(CDI) Champion" have indicated that they find the position both frustrating

and possibly ineffectual, given the time constraints and degree of nursing

understaffing on the medical nursing units. That proposals are currently underway to close the microbiology

laboratory at Burnaby Hospital, under the auspices of Regional Laboratory Consolidation, despite the lack of evidence that such actions will reduce

costs or maintain quality of care.

That the Burnaby Hospital Pathologists participate in the local Infection

Control Committee as well as accept on-call responsibility for infection control management at this facility despite the fact they are:

• Not remunerated for this service.

• Not allocated time to manage this service.

• Not contractually obligated to perform this service. That the Burnaby Hospital Pathologists have made record in the minutes

of the Infection Control Committee, and reiterate again for your

notification, that their participation in these services will immediately end upon decision to close the microbiology laboratory at Burnaby Hospital.

That, to my knowledge, no contingency plans are currently in place to maintain on-call continuity of care for infection control management, should this come to pass.

• That a longstanding stalemate in regards to funding for Infection Control on-call coverage continues to persist between Mr. Marc Pelletier and Dr. Andrew Webb.

In summary, we would characterize current CDAD infection control management at Burnaby Hospital, at best, as a serious hazard to the patient population served

by the Fraser Health Authority and describe the coordination of this activity at both the local and regional levels, at best, as chaotic.

Such is the degree of the CDAD problem and the ineffectual response to it, that

we believe it could objectively be considered medical negligence. As such, we

believe the Fraser Health Authority has placed itself at significant risk of medical- legal action based on generally accepted principles of medical litigation:

• There was a medical-legal duty to care.

• This duty was breached based on failure to conform to accepted standards of care.

• This breach in duty resulted in injuries.

• Significant damages have been incurred by affected patients and families.

We believe the only reason that such action has not already taken place is the

lack of public transparency as to the extent of the problem. This raises a very

disturbing ethical question to the extent that there has been full disclosure to affected patients and families, in that damages endured were not random or unpredictable events, but the consequence of a persistent lack of coordinated control over an extended period of time.

We would point out a recent Canadian example of the consequences of

uncontrolled C. difficile management, in the form of the recently certified $50 million dollar class action lawsuit filed against Joseph Brant Memorial Hospital in Ontario. We include the summary findings of Stutts& Strosberg LLP representing

this case:

The law firms of Stanley M. Tick & Associates and Sutts, Strosberg LLP are counsel in a class action commenced by statement of claim on July 9, 2008 on behalf of all patients who contracted ClostrJdium difficile ("C. difficile") at Joseph Brant Memorial Hospital ("Brant Hospital") between May 1, 2006 and December 31, 2007.

, C. difficile is a bacteria which infects the intestines and causes illness ranging from diarrhea, nausea, vomiting, weight loss, fever, colitis, and in some cases, death. It is highly contagious.

, Between May 1, 2006 and December 31, 2007, approximately 225 patients at Brant

Hospital were diagnosed with C. difficile. At least 91 patients who were diagnosed with C. difficile died.

, The class action names Brant Hospital as the defendant. It alleges, among other things,

that the defendant was negligent in the manner in which it cleaned, maintained and disinfected Brant Hospital.

5. On October 4,2011, this action was certified as a class action by Justice Baltman.

We are certain it is apparent that these findings could equally apply to the current

circumstances.

There is no shortage of available management recommendations as to the proper course of action to obtain control of this problem. We include copies of

review articles from the CMAJ to that effect, a copy of the BCCDC review of Nanaimo Hospital from 2008 which we believe could apply equally well to

Burnaby Hospital, and a copy of the raw data as to Fraser Health Authority CDAD numbers. Of course, close attention to Dr. Michael Gardam's preliminary and finalized reports, when completed, is recommended.

I also include a copy of the latest report of the Provincial Infection Control

Network of British Columbia, again demonstrating Burnaby Hospital having the worst rates of CDAD in the province. Within that document, we would further address your attention to page 13 of the report under "Laboratory. Methodology".

The Fraser Health Authority currently uses an older method of C. difficile antigen

detection, significantly less sensitive then nucleic acid detection technology,

reportedly by up to 35%. This may actually result in under-reporting of CDAD

rates in the Fraser Health Authority relative to other regions of the province.

We would close by making note of the Fraser Health Authority's recent "350 bed

initiative", the purpose of which to free up the equivalent of 350 patient bed-days

per year through discovery of hospital efficiencies within the Health Authority with

no additional provincial funding. We understand the intent to be to decrease average in-patient stay from the current 8.3 days to 7.2 days by fiscal year

2013/14. We would point out the recently published article by Forster et aL which shows that the average increase in length of stay for inpatients with nosocomial

CDAD is 6 days. Given the numbers of serious CDAD cases, that would be the equivalent of approximately 2,800 patient bed-days over the last two and a half years at Burnaby Hospital alone. We would also point out that is also likely a significant underestimate, as we have only given you the number of serious CDAD cases at Burnaby Hospital, not the total number of cases.

The prompt and much delayed intervention by yourself and the senior local and regional administration in addressing these significant problems is needed. The summary of our immediate recommendations are included in the preceding executive summary.

Sincerely,

Dr. Shane Kirby, PhD, MD, FRCPC

General Pathologist, Burnaby Hospital

Dr. Pat Zaidel

Committee

Department Head, Internal Medicine, Burnaby Hospital

Dr. Farzad Saberi

Department Head, Acute Medicine, Burnaby Hospital

.J, ./,.,4

7-/./

Dr. Gary Baxendale

Department Head, Emergency Medicine, BurnabyHospital

Dr. j cÿjUÿ/.ÿ'ÿÿ ÿ

Department Head, Hospitalists, Bumaby Hospital

Di*, Jÿ

Department Head, Surgery, Burnaby Hospital

t

Dr. Elizabeth Earle

Department Head, Laboratory, Burnaby Hospital

Infectious Disease Consultant, Burnaby Hospital/Richmond Hospital

cc/

Dr. Andrew Webb

VP Medicine, Fraser Health Authority

Infectious Diseases Consultant, Medical Director, Infection Prevention

Dr. Fred Roberts Dr. Arun Garg Dr. David Jones Dr. Michael Gardam

Regional Medical Director, Infection Control, Fraser Health Authority Regional Medical Director, Laboratory, Fraser Health Authority Former Medical Director, Burnaby Hospital

Mr. Marc Pelletier Ms. Petra Welsh Ms. Cathy Heritage Ms. Sheila Finamore Ms. Elizabeth Findley Ms. Noorsallah Esmail Ms. Patricia Smid Ms. Sandy Daniels Ms. Valerie Schall

and Control, University Health Network and Women's College Hospital Medical Director, Tuberculosis Clinic, Toronto

VP Clinical Operations and Clinical Support, Fraser Health Authority

Regional Executive Director, Infection Control, Fraser Health Authority Executive Director, Bumaby Hospital Site Director, Bumaby Hospital Former Site Director, Burnaby Hospital Infection Prevention and Control Practitioner, Burnaby Hospital Manager, Emergency Department, Burnaby Hospital Manager, Infection Prevention and Control, Fraser Health Authority Manager, Infection Prevention and Control, Fraser Health Authority

All Medical Department Heads, Burnaby Hospital

References:

Susy S. Hota, Camille Achonu, Natasha S. Crowcroft, Bart J, Harvey, Albert Lauwers and

Michael A. Gardam. 2012. Comparison of 3 methods for determining attributable mortality in patients with Clostridium difflcile infection (CDI), In press, Emerging Infectious Disease.

Alan J. Forster, Monica Taljaard, Natalie Cake, Kumanan Wilson, Virginia Roth, Carl van Walraven. 2011. The effect of hospital-acquired infection with Clostridium difficile on length of stay in hospital. Canadian Medical Association Journal Accelerated article published on-line prior to print. DOI: 10.1503/cmaj. 1 !0543

Susan M. Poutanen, Andrew E. Simor. 2004. Clostridium difficile-associated diarrhea in adults. Canadian Medical Association Journal. 171 (11 ): 51-58.

Ca&adian Medical Association Journal. 171

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