Questions and Answers

• What is Clostridium difficile (C.difficile)?
• What are the risk factors for Clostridium difficile infection (CDI)?
• Why is it important to look at hospital-acquired infections?
• Why are hospitals adopting a monitoring and reporting system for hospital-acquired infections?

• What are the expectations for public reporting C.difficile?
• Does public reporting of CDI apply to all hospitals or just all acute hospitals?
• Are multi-site hospitals required to report CDI data by corporation or by site?
• What criteria will be used to determine comparator sites?
• What data are hospitals required to report publicly?
• How are CDI rates calculated?
• How does the hospital send the C. difficile data to the MOHLTC?
• What should hospitals be doing if their CDI rates are high?
• Will CDI rates vary from hospital to hospital depending on the type of patients served by the hospital?
• Is data to be collected on both acute and chronic patients?

• How is a CDI outbreak declared?
• When a hospital has an outbreak of CDI, what are the reporting and outbreak management requirements?

C.difficile is a spore-forming bacteria that is widely distributed in the environment and can colonize up to 3-5% of adults in the community without causing symptoms. C.difficile produces spores that are resistant to destruction by many environmental influences. The spread of C.difficile occurs due to inadequate hand hygiene and environmental cleaning. C.difficile as been a known cause of healthcare associated diarrhea for about 30 years.

The case definition for Clostridium difficile infection (CDI) can be found in the glossary.

Certain people are at increased risk for acquiring CDI. These risk factors include :

• History of antibiotic usage
• Bowel surgery
• Chemotherapy
• Prolonged hospitalization
• Being elderly
• Serious underlying illness or debilitation

Hospital-acquired infections have a direct impact on patient safety and health care quality. They may be life-threatening and are costly to the healthcare system.

The main objective of the monitoring and reporting system is to track trends in CDI in each of the province’s hospitals in order to adopt control measures appropriate to each hospital facility. Reporting allows a hospital to measure its performance.

On the last day of each month, beginning September 26, 2008, all Ontario hospitals will be required to publicly report on :

• rates of new nosocomial CDI cases associated with the reporting facility, separately for each hospital site, and
• the number of new nosocomial CDI cases associated with the reporting facility (count) separately for each hospital site.

The Ministry of Health and Long-Term Care will also report on its own website :

• rates of new nosocomial CDI cases associated with the reporting facility, separately for each hospital site, and
• the number of new nosocomial CDI cases associated with the reporting facility (count) separately for each hospital site.

For the first public report, the Minister will be releasing the hospital CDI reported information on the ministry web site on September 26, 2008. Hospitals are encouraged to post their information on the same day.

Before reporting the data on the hospital website, hospitals are required to send their CDI data to the MOHLTC for review and validation. The MOHLTC will require this data by the 15th of every month to meet monthly posting requirements.

The requirement to report to the public on CDI applies to all Ontario public hospitals. All hospitals are also required to report an outbreak to their public health unit.

Hospitals with multi-sites should be measuring, collecting, and reporting data for each site rather than providing an overall rate as these can vary widely between sites.

The ministry web site will report on hospitals by individual sites. Hospitals are requested to post their CDI rates by hospital site.

Hospital data will be reported by hospital type groups.

All hospitals are required to report rates, patient days and case counts.

NOTE : Please see the glossary section for definitions of the technical terms used below

The CDI count is the number of new nosocomial cases of CDI by month.

The rate of CDI is calculated as follows :

The number of new nosocomial cases of CDI associated with the reporting facility multiplied by 1000, then divided by the number of patient days.

The denominator, patient days data, should be sourced from the hospital’s daily bed census data.

This rate represents the incidence rate of nosocomial CDI associated with the reporting facility per 1000 patient days.

Exclusion criteria for data: children under 1 year should be excluded from numerator and denominator. All other patients (e.g. mental health and rehab) should be included.

Starting September 15, 2008 and by the 15th of every month, hospitals will be required to provide CDI data using the Web Enabled Reporting System (WERS) database to the MOHLTC.

Hospitals that identify a high rate of CDI should review their infection prevention and control practice to ensure that it aligns with what has been provided to them, including the PIDAC documents; ‘Best Practices for the Management of Clostridium difficile in all health care settings’, ‘Best Practices for Hand Hygiene in all health care settings’ and the MOHLTC ‘Just Clean Your Hands’ program.

In addition, they should review their environmental cleaning practices to ensure that they are following the PIDAC C. diffiicile best practice document. Hospitals should also consult with their local public health unit to identify any further action that is required.

Rates may vary. For example, if there are large regional cancer centers attached to a hospital, there might be elevated rates of C. difficile. Hospitals must know their baseline rates, as well as how they compare to similar hospitals. They will then be able to identify when rates are rising. It is useful to stratify unique settings by size and risk.

Data (numerator and denominator) must be collected on all patients (e.g., acute, chronic, rehab, mental health), with the exception of patients under 1 year of age.

CDI outbreak definitions incorporate the concept of notification thresholds that optimally trigger action and dialogue between public health and hospitals to determine if an outbreak is occurring. CDI notification thresholds replace the existing outbreak definitions that were issued on September 1, 2008.

Notification thresholds are more sensitive than outbreak definitions and are defined as :

1. For wards/units with ≥ 20 beds, 3 cases of nosocomial CDI identified on one ward/unit within a seven day period or 5 cases within a 4 week period; OR
2. For wards/units with < 20 beds, 2 cases of nosocomial CDI identified on one ward/unit within a seven day period or 4 cases within a 4 week period; OR
3. Hospitals that have a baseline CDI rate for two months that is at or above the 80th percentile for comparator hospitals; OR
4. Hospitals that have a facility rate that is greater than or equal to 2 standard deviations above their baseline.

Note : This does not apply to small hospitals with a single case of nosocomial CDI which artificially elevates the facility rate

Following consultation between the institution and the Medical Officer of Health (MOH), decisions on the declaration of an outbreak will be made based on the following two criteria :

• Significant* (as determined by the facility and health unit) increase in CDI numbers or rate compared to own baseline and/or that of comparator institutions
• Epidemiologic evidence of ongoing nosocomial transmission within the ward/unit or facility

*Significance may be determined by reviewing :

• Number of new nosocomial cases associated with the reporting ward/unit or facility;
• Historic level of CDI activity of the ward/unit or facility;
• Current trend in ward/unit CDI activity or facility rate;
• Location of current cases and possible epidemiologic links between cases;
• Current control measures (and evidence that they are being implemented).

It should be noted that exceeding a threshold does not necessarily imply that an outbreak will be declared. Declaration of an outbreak can be made by either the institution or the MOH.

As of September 1, 2008, CDI outbreaks in hospitals became a reportable disease. Therefore, all hospitals are required to report an outbreak to their local Public Health Unit (PHU) to inform them of the outbreak.

An Outbreak Management Team, consisting of members of the hospitals infection prevention and control program, affected departments and Senior Management and representation from the local public health unit, is formed.

This group provides the day-to-day management of the outbreak and is the liaison between the hospital and public health. At the end of the outbreak, this group will review all aspects of the outbreak and provide recommendations to the hospital to assist in preventing future outbreaks.

Hospitals are encouraged to post on their web sites when their hospital is in an outbreak, the exact units and when the outbreak is over.

The ministry, starting with the October 31st posting on the ministry web site, will list hospitals that have been in outbreak for the previous month (ie, September). The public will be encouraged to contact the hospital directly for additional information.