January 9t", 2011

fraserhealth Better health.Best in health care.

Executive Summary: Clinically unacceptable rates of nosocomialClostridium difficile infection at Burnaby Hospital,

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

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

Correcting these problems will not only improve patient safety, but address theFraser Health Authority's own quality initiatives of increased efficiency and costeffectiveness, such as the "350 Challenge".

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

At the

II

local level of Burnaby Hospital:

Immediate institution of enhanced cleaning of hospital unitsshowing high endemic rates of CDAD until further notice.

• Review of the adequacy of local Infection Control Practitioner andunit 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, medicalmicrobiology and pharmacy services as they pertain to stewardshipof antibiotic and PPI usage and support of best medical practicesfor infection control practitioners.

• Immediate and personal responsibility of the local Site Director incoordinating these activities and ensuring their effectiveness.

• Establishment of specific timelines for review of the implementationof these changes, review of their effectiveness and institution offurther changes as required.

• Aggressive implementation of the recommendations of Dr. MichaelGardam as to CDAD control measures, once the final report isavailable.

Burnaby HospitalFraser Health Authority

3935 Ktncaid StreetBurnaby BCVSG 2X6 Canada

At the regional level of the Fraser Health Authority:

Review of the contractual definition as to-the roles of the MedicalDirector of Infection Control and the adequacy of the current FTEfunding for that duty.

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

• Resolution of the responsibility of the vadous arms of the FraserHealth Authority Executive for management and funding of on-callcoverage of infection control services.

• Establishment of an authoritative regional triage system to controlCDAD and other infection control outbreaks, as per.the Ontariomodel.

• Review of the currently used laboratory methodology for CDADdetection in the Fraser Health Authority.

• Review of the adequacy of current Infection Control Practitionerstaffing at the various medical facilities within the Health Authority.

• Review of the adequacy of currently existing contracts for hospitalcleaning operations.

• Establishment of specific timelines for review of the implementationof these changes, review of their effectiveness and institution offurther changes as required.

• Aggressive implementation of the recommendations of Dr. MichaelGardam as to CDAD control measures, once the final report isavailable.

January 9th, 2012

fraserheaith Beffer healfh.Best in health care,

Dr. Nigel Murray, CEO, Fraser Health Authority

Dear Nigei,

We are writing to you as rePresentatives of the Burnaby Hospital InfectionControl Committee and concerned medical staff to ensure your awareness of thescope of the continuing issues in regards to Clostridium difficile associateddiarrhea (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 twoyÿ,ÿrÿ--(mean 1.95 cases per t000 patient days; national/provincial averageestimate 0.8 cases per 1000 patient days). These rates are reminiscent of theCDAD issues impacting Nanaimo General Hospital in 2008 (see appendeddocument), which prompted external review by the BC Center for DiseaseControl (BCCDC). They are also equivalent to the rates of CDAD in the hospitalsof the Niagara Region, which resulted in subsequent media frenzy andgovernmental led reviews and changes in CDAD reporting and management inOntario.

To give you a sense of raw numbers, epidemiologic infection and preventioncontrol data i requested compiled this past December show that over the periodof the last two and a half years (2009 to mid-2011ÿ&tBurnaby Hospital alonewithin the Fraser Health Authority, there have beenj47ÿerio#s cases of CDADcolitis, 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 promptedunprecedented unit closures in late 2011. I assure you, these latter numbers willbe high.

This mortality statistic recorded by the Fraser Health Authority is patient deathwithin 30 days of a positive C. difficile test. Of course, this raises the question asto how many of these deaths are directly attributable rather than simplyassociated with CDAD colitis, it would be of interest to you that Dr. MichaelGardam, an internationally recognized authority on CDAD infection controlmanagement, was recently invited to perform an impromptu review of infectioncontrol management at Burnaby and Royal Columbian Hospitals in November2011. He has recently published an article currently in press which directlyaddresses this issue. Retrospective review of this 30-day mortality statistic, alsorecorded in Ontario hospital CDAD outbreaks, demonstrated 80% of these

Burnaby HospitalFraser Health Authority

3935 Kincaid StreetBurnaby BCVSG 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 inhibitorusage.

• 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 andexcessively costly to rectify. There is little that can be done on a local facilitybasis to control patient numbers or their predisposition to acquiring CDAD colitis.However, under medical management and infection control measures, there is asignificant gap in both local and regional administrative support and resources inBurnaby Hospital and the Fraser Health Authority. This is a problem that can berapidly 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 thepositions of local Medical Directors, replacing them by non-clinicianadministrative Site Directors. This was ostensibly a cost savings measure. Thelocal Medical Director was typically an experienced physician with intimateknowledge of both local medical staff and local facility issues and representedthe mechanism by which local hospital medical issues may be resolved.

In the absence of a Medical Director, this responsibility has fallen to the SiteDirector. I make note of the fact that our local Site Director has been absent forall of the Burnaby Hospital Infection Control Committee meetings of 2011,including the emergency meetings convened to manage the unprecedentedCDAD outbreaks and resulting unit closures in the latter half of the year. Therehas also been no senior administrative representation to the Burnaby HospitalInfection 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 ofintractable CDAD colitis earlier in 20111

Indeed, we are informed that technically the local Infection Control Committee nolonger exists under Program Management as, under this system, it has no formalintegration or reporting structure within the Fraser Health Authority. As a result,the Committee has been reduced to a role of documenting problems, with nomechanism to report or address such issues to any authority. Should you wish,the Bumaby Hospital Infection Control Committee is prepared to cease itsactivities and dissolve the Committee.

We would also like to point out the minimization of the scope of the BurnabyHospital CDAD problem by our local Site. Director, which illustrates the lack ofemphasis on improved and sustained infection control measures. In the meetingFebruary 1st, 2011 between the Site Director, local infection control practitionersand myself convened to address concern in regards to the excessive rates ofCDAD, our Site Director expressed the opinion that "the problem is getting better"an opinion also recorded in the minutes of the Burnaby Hospital MultidisciplinaryHealthcare Coordination Committee (MHCC) in the spring of last year. We notethat as of December 2011 our local Site Director has moved on to a different rolewithin the Fraser Health Authority. One would hope that the role of Site Directorwill not become a revolving door, as it is difficult to envision how this will lead toquality management; this CDAD issue a case in point.

As we hope you are aware, shortly thereafter were two subsequent and locallyunprecedented outbreaks of CDAD colitis at Bumaby Hospital in the latter half of2011, 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. Suchwas the concern in regards to patient care and overflow within the ED, thequestion was raised at the last meeting of the Infection Control CommitteeNovember 30th, 2011 whether the ED could overturn unit closurerecommendations out of medical necessity.

It has been the practice of infection control management that individual patientadmission to a closed unit will be considered based on medical necessity on acase-by-case basis. However, should the need arise to open entire closed unitsto admissions, both Dr. Fred Roberts and I are in agreement that such decisionshould only be undertaken by the highest executive within the Fraser HealthAuthority. 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 "fecaltransplantation" is a poor idea at Burnaby Hospital for a multitude of reasons, which has beendocumented in the minutes of the Infection Control Committee.

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

However, Program Management only represents part of the lack of coordinatedor organized administrative management of infection control in this HealthAuthority at either the local or regional level. Other notable examples including:

The fact that the Fraser Health Authority relies on Dr. Fred Roberts, theRegional Medical Director of Infection Control to manage on a part time0.7 FTE basis, a health care operation roughly the size of Belgium.The fact that Dr. Fred Roberts has indicated he would prefer to step downfrom this role in 2012 rather than accept the currently proposedcontractual roles of Regional Medical Director of Infection Control.The fact that the Fraser Health Authority has yet to identify any successorfor the role of Regional Medical Director of Infection Control, should thattake place.That specific request at Burnaby Hospital for enhanced cleaning of highCDAD rate medical units, made at the behest of the Infection ControlCommittee to manage the latest outbreak in November 2011 has still notbeen implemented over a month later.That temporary one-year funding from local administration for the uniteducational role of "C. difficile Infection (CDI) Champion" has beenallowed 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 frustratingand possibly ineffectual, given the time constraints and degree of nursingunderstaffing on the medical nursing units.That proposals are currently underway to close the microbiologylaboratory at Burnaby Hospital, under the auspices of Regional LaboratoryConsolidation, despite the lack of evidence that such actions will reducecosts or maintain quality of care.That the Burnaby Hospital Pathologists participate in the local InfectionControl Committee as well as accept on-call responsibility for infectioncontrol 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 minutesof the Infection Control Committee, and reiterate again for yournotification, that their participation in these services will immediately endupon decision to close the microbiology laboratory at Burnaby Hospital.That, to my knowledge, no contingency plans are currently in place tomaintain on-call continuity of care for infection control management,should this come to pass.

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

In summary, we would characterize current CDAD infection control managementat Burnaby Hospital, at best, as a serious hazard to the patient population servedby the Fraser Health Authority and describe the coordination of this activity atboth the local and regional levels, at best, as chaotic.

Such is the degree of the CDAD problem and the ineffectual response to it, thatwe believe it could objectively be considered medical negligence. As such, webelieve 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 thelack of public transparency as to the extent of the problem. This raises a verydisturbing ethical question to the extent that there has been full disclosure toaffected patients and families, in that damages endured were not random orunpredictable events, but the consequence of a persistent lack of coordinatedcontrol over an extended period of time.

We would point out a recent Canadian example of the consequences ofuncontrolled C. difficile management, in the form of the recently certified $50million dollar class action lawsuit filed against Joseph Brant Memorial Hospital inOntario. We include the summary findings of Stutts& Strosberg LLP representingthis case:

The law firms of Stanley M. Tick & Associates and Sutts, Strosberg LLP are counsel in aclass action commenced by statement of claim on July 9, 2008 on behalf of all patientswho 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 fromdiarrhea, nausea, vomiting, weight loss, fever, colitis, and in some cases, death. It ishighly contagious.

, Between May 1, 2006 and December 31, 2007, approximately 225 patients at BrantHospital 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 anddisinfected 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 currentcircumstances.

There is no shortage of available management recommendations as to theproper course of action to obtain control of this problem. We include copies ofreview articles from the CMAJ to that effect, a copy of the BCCDC review ofNanaimo Hospital from 2008 which we believe could apply equally well toBurnaby Hospital, and a copy of the raw data as to Fraser Health AuthorityCDAD numbers. Of course, close attention to Dr. Michael Gardam's preliminaryand finalized reports, when completed, is recommended.

I also include a copy of the latest report of the Provincial Infection ControlNetwork of British Columbia, again demonstrating Burnaby Hospital having theworst rates of CDAD in the province. Within that document, we would furtheraddress your attention to page 13 of the report under "Laboratory. Methodology".The Fraser Health Authority currently uses an older method of C. difficile antigendetection, significantly less sensitive then nucleic acid detection technology,reportedly by up to 35%. This may actually result in under-reporting of CDADrates 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 bedinitiative", the purpose of which to free up the equivalent of 350 patient bed-daysper year through discovery of hospital efficiencies within the Health Authority withno additional provincial funding. We understand the intent to be to decreaseaverage in-patient stay from the current 8.3 days to 7.2 days by fiscal year2013/14. We would point out the recently published article by Forster et aL whichshows that the average increase in length of stay for inpatients with nosocomialCDAD is 6 days. Given the numbers of serious CDAD cases, that would be theequivalent of approximately 2,800 patient bed-days over the last two and a halfyears at Burnaby Hospital alone. We would also point out that is also likely asignificant underestimate, as we have only given you the number of seriousCDAD cases at Burnaby Hospital, not the total number of cases.

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

Sincerely,

Dr. Shane Kirby, PhD, MD, FRCPC

General Pathologist, Burnaby HospitalCommittee

Dr. Pat Zaidel

Department Head, Internal Medicine, Burnaby Hospital

Dr. Farzad Saberi

Department Head, Acute Medicine, Burnaby Hospital

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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

tDr. Elizabeth Earle

Department Head, Laboratory, Burnaby Hospital

Infectious Disease Consultant, Burnaby Hospital/Richmond Hospital

cc/

Dr. Andrew WebbDr. Fred RobertsDr. Arun GargDr. David JonesDr. Michael Gardam

Mr. Marc PelletierMs. Petra WelshMs. Cathy HeritageMs. Sheila FinamoreMs. Elizabeth FindleyMs. Noorsallah EsmailMs. Patricia SmidMs. Sandy DanielsMs. Valerie Schall

VP Medicine, Fraser Health AuthorityRegional Medical Director, Infection Control, Fraser Health AuthorityRegional Medical Director, Laboratory, Fraser Health AuthorityFormer Medical Director, Burnaby HospitalInfectious Diseases Consultant, Medical Director, Infection Preventionand Control, University Health Network and Women's College HospitalMedical Director, Tuberculosis Clinic, TorontoVP Clinical Operations and Clinical Support, Fraser Health AuthorityRegional Executive Director, Infection Control, Fraser Health AuthorityExecutive Director, Bumaby HospitalSite Director, Bumaby HospitalFormer Site Director, Burnaby HospitalInfection Prevention and Control Practitioner, Burnaby HospitalManager, Emergency Department, Burnaby HospitalManager, Infection Prevention and Control, Fraser Health AuthorityManager, 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 andMichael A. Gardam. 2012. Comparison of 3 methods for determining attributable mortality inpatients with Clostridium difflcile infection (CDI), In press, Emerging Infectious Disease.

Alan J. Forster, Monica Taljaard, Natalie Cake, Kumanan Wilson, Virginia Roth, Carl vanWalraven. 2011. The effect of hospital-acquired infection with Clostridium difficile on length ofstay in hospital. Canadian Medical Association Journal Accelerated article published on-lineprior 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.

(1Ca&adian Medical Association Journal. 171numbers.