Health Quality Council of Alberta announces findings and recommendations related to its review of infection prevention and control and CSR sterilization issues in East Central Health Region

    CALGARY, July 25 /CNW/ - The Health Quality Council of Alberta (HQCA)
today released its findings and recommendations related to infection
prevention and control (IPC), including Methicillin Resistant Staphylococcus
aureus (MRSA), and sterilization practices in East Central Health (ECH). The
report also includes findings and recommendations from site visits, interviews
and a review of relevant documentation of the quality and safety practices
related to IPC and sterilization practices at all acute care facilities either
operated by, or under contract to, ECH. While both these infection control
issues culminated in the Order, they were unrelated and occurred parallel to
one another.
    Alberta Health and Wellness requested the review as a result of a
March 16, 2007 Medical Officer of Health Order that identified issues related
to IPC and sterilization practices at St. Joseph's General Hospital (SJGH) in
Vegreville. Under section 13 of the Health Quality Council of Alberta
Regulation, the HQCA is legislated to conduct such inquiries into the safety
and quality of patient services in the province.
    In releasing the report, Dr. John Cowell, chief executive officer of the
Council, said "The findings and recommendations were developed following a
thorough process that included a root cause analysis (an investigative tool to
perform a comprehensive, system-based review of critical incidents) and
interviews that included board members, staff, physicians and administrators
from St. Joseph's Hospital, East Central Health Region and Alberta Catholic
Health Corporation. The process also included a detailed review of relevant
documents and on-site visits. The inquiry was conducted by a highly
experienced and qualified investigative team. We believe the HQCA's
recommendations will result in a safer health system not only for citizens in
East Central Health but for all Albertans."

    Key findings from the report include:

    1.  The root cause of both the Central Sterilization Room (CSR) closure
        and the lack of containment of MRSA was found in legislation and
        agreements that governed operations of ECH Region and SJGH. Voluntary
        (often referred to as faith-based) facilities such as SJGH and the
        Regional Health Authorities (e.g. ECH) had both been given "final
        authority" for operation of health facilities within the region by
        the Master Agreement (1994), which covered Voluntary facilities, and
        the Regional Health Authorities Act (1994), which covered the
        regional health authorities respectively. Lack of agreement on which
        entity had working and governing authority led to lack of
        accountabilities and responsibilities for infection prevention and
        control, quality improvement, patient safety, and risk management.
        This ambiguity allowed unsafe practices to continue.

        HQCA Recommendation: Alberta Health and Wellness immediately review
        the Master Agreement and RHA Act and identify ONE entity to have
        final authority for all matters relating to the operation of the
        health care facilities in a regional health authority. See full
        report for other related recommendations.

    2.  There was a strained working relationship between SJGH and ECH, which
        failed to ensure that best practices in sterilization and IPC were
        implemented in SJGH, despite knowledge that practices there did not
        meet ECH standards. Historically, ECH operated under the
        understanding that they needed to be "invited in" to SJGH to make any
        changes to services and SJGH considered directives from ECH
        "optional".

        HQCA Recommendation: Define the relationship between ECH and SJGH in
        the Service Agreement and ensure that the authority, accountability
        and responsibility of regional managers and senior management is also
        clearly defined for quality and safety. (See full report for other
        related recommendations 2A-2D)

    3.  Lack of a widespread patient safety culture and alignment of
        organizational structure to support patient safety did not allow for
        identification of key safety issues that required immediate action at
        the senior administration and board levels in both ECH and SJGH.

        HQCA Recommendation: Actively define and create a culture of safety
        that empowers all staff, managers, administrators, Board members and
        physicians to improve patient-related care using strategies such as
        regular safety culture surveys of staff, regular quality/safety
        rounds, regular (transparent) performance indicator reports,
        administrative walkabouts, routine addition of patient safety and
        quality topics to all meeting agendas, and any other patient safety
        initiatives that would be appropriate. See full report for other
        related recommendations.

    4.  Chart audits of patients who may have experienced adverse outcomes as
        a result of MRSA or use of surgical instruments that were
        inappropriately cleaned and sterilized in SJGH are in process but are
        proceeding slowly.

        HQCA Recommendation: Chart audits need to be conducted and with a
        greater sense of urgency. See full report for other related
        recommendations.

    5.  Central Sterilization Room reviews in 11 other acute care sites in
        ECH revealed a spectrum of deviation from the Canadian Standards
        Association standards in all sites. Deviations ranged from practices
        that introduce a source of contamination but are readily resolvable
        (e.g., removal of corrugated cardboard, which may harbour
        contaminants such as fungus) to more serious practices such as
        disinfection versus sterilization of foot care instruments. A review
        of documentation revealed re-use of cautery devices intended for
        single use only items.

        HQCA Recommendation: Ensure practices meet CSA standards. See full
        report for detailed listing of required action pages 47, 50-58.

    The report includes over 100 additional recommendations that impact St.
Joseph's Hospital, East Central Health and Alberta Health and Wellness. The
recommendations identify broad scope opportunities for improving system
quality and safety with a focus on infection prevention and control and
sterilization practices throughout the health care system.
    "Our goal was not to lay blame on any one individual or organization but
to look at system-wide issues and opportunities for improvement. Throughout
the course of the HQCA review, we found that some of the recommended practices
identified in the review are now being acted upon," says Cowell. "We are
confident the organizations involved have learned from the situation and will
strengthen existing policies, processes and practices and introduce new ones
based on this review."
    "We expect the results of this review will help inform the whole health
system," adds Cowell. "As an independent organization, the HQCA is committed
to quality and safety improvement at the provincial level. We expect that the
government, health regions and health professions will review the report and
take the appropriate action as relevant within their area of responsibility."
    The findings are being presented to Alberta Health and Wellness. The
Council conducted its inquiry from the point of view of the patient
experience. Its recommendations are aimed at system-wide quality improvement
based on the six dimensions of quality identified in the Alberta Quality
Matrix for Health: Acceptability, accessibility, appropriateness,
effectiveness, efficiency and safety.
    For a copy of the full report go to www.hqca.ca.

    Backgrounder follows: Summary of HQCA recommendations.

                      Health Quality Council of Alberta
     Review of the Infection Prevention and Control and CSR Sterilization
                     Issues in East Central Health Region

                         Summary of Recommendations

                                  July 2007

                                                                Backgrounder

    The Health Quality Council of Alberta (HQCA) has released its findings
and recommendations related to infection prevention and control (IPC),
including Methicillin Resistant Staphylococcus aureus (MRSA), sterilization
practices in East Central Health (ECH). The report was based on a full
investigation including site visits, interviews and a review of relevant
documentation of the quality and safety practices related to IPC and
sterilization practices at all acute care facilities either operated by, or
under contract to, ECH.
    Alberta Health and Wellness requested the review as a result of a
March 16, 2007 Medical Officer of Health (MOH) Order that closed the St.
Joseph's General Hospital in Vegreville to new admissions. Under section 13 of
the Health Quality Council of Alberta Regulation, the HQCA is legislated to
conduct such inquiries into the safety and quality of patient services in the
province.
    The MOH Order was enacted based on evidence of inadequately sterilized
medical equipment and an inability to contain the ongoing spread of MRSA.
While both these infection control issues culminated in the Order, they were
unrelated and occurred parallel to one another.
    Immediate action following the MOH Order was taken by ECH that included
closure of the Central Sterilization Room (CSR), implementation of enhanced
containment strategies to manage the MRSA, establishment of criteria to be
complied with before re-admissions could occur, a look back process to
determine if any patients who had undergone surgery or other procedures had
been infected with Hepatitis B, Hepatitis C and/or Human Immunodeficiency
Virus (HIV), and initiation of a chart audit to assess evidence of adverse
events in patients linked with either CSR sterilization or MRSA transmission.
    An Investigative Team was struck by the HQCA, under the direction of Dr.
John Cowell, CEO, consisting of three experienced individuals with expertise
in the area of patient safety and quality and an Expert Advisory Panel with
expertise in CSR and infectious diseases. All activities of the Investigative
Team and Expert Advisory Panel were conducted under the auspices of the
Quality Assurance Committee of the HQCA and were protected by the Alberta
Evidence Act.

    Objectives of the Review

    Alberta Health and Wellness identified the following objectives for the
    HQCA:

    1.  Identify the factors impacting IPC at St. Joseph's Hospital that led
        up to the Medical Officer of Health Order to St. Joseph's Hospital
        dated March 16, 2007.
    2.  Assess the adequacy and appropriateness of the response by St.
        Joseph's Hospital, East Central Health Region and Alberta Health and
        Wellness to the identified IPC issues outlined in the MOH Order.
    3.  Make recommendations to ensure the contributing factors and root
        cause(s) of infection control practices, including transmission of
        MRSA, identified are addressed within the St. Joseph's General
        Hospital, the East Central Health Region and the provincial health
        system.
    4.  Review all facilities operated under contract (Voluntaries) within
        the East Central Health Region, as well as facilities operated by
        East Central Health, in terms of infection prevention and control
        procedures and practices and risk management.

    Methodology

    Part 1 of the investigation and final report used interviews, analysis of
documentation, and a root cause analysis process (an investigative tool to
perform a comprehensive, system-based review of critical incidents) to
identify the factors and root causes leading up to the MOH Order and make
relevant recommendations addressing the IPC and sterilization issues at SJGH
and ECH and within the provincial health system.
    Part 2 assessed the adequacy and appropriateness of response to the MOH
Order by SJGH, ECH and AHW through interviews, observations and analysis of
relevant documentation.
    Part 3 of the final report and investigation reviewed all acute care
facilities operated by ECH (both Voluntary and Non-Voluntary facilities) in
terms of infection prevention and control procedures and practices and risk
management, and was completed through visits to all 11 acute care facilities
within ECH with a focus on the operation of the CSR as well as through
interviews and analysis of documentation. Reports from other relevant external
reviews were also reviewed. Recommendations relevant to ECH and the provincial
health system are made.

    Recommendations

    Part 1: Root Cause Analysis Report

    Theme: Governance and Administration: Legislation and agreements
governing regional health authorities and Voluntary facilities, coupled with
poor working relationships, resulted in unclear accountabilities and
responsibilities and presented patient safety hazards.

        Finding: The root cause of both the Central Sterilization Room (CSR)
        closure and the lack of containment of MRSA was found in legislation
        and agreements that governed operations of East Central Health (ECH)
        Region and St. Joseph's General Hospital (SJGH). Voluntary (often
        referred to as faith-based) facilities such as SJGH and the Regional
        Health Authorities (e.g. ECH) had both been given "final authority"
        for operation of health facilities within the region by the Master
        Agreement (1994), which covered Voluntary facilities, and the
        Regional Health Authorities Act (1994), which covered the regional
        health authorities respectively. Lack of agreement on which entity
        had working and governing authority led to lack of accountabilities
        and responsibilities for infection prevention and control, quality
        improvement, patient safety, and risk management. This ambiguity
        allowed unsafe practices to continue.

        Recommendation: Alberta Health and Wellness must immediately review
        the Master Agreement and RHA Act and identify ONE entity to have
        final authority for all matters relating to the operation of the
        health care facilities in a regional health authority.

        (See also causes and recommendations 1, 1A, 1B, 1G, 3, 3A, 3B, 6, 6A,
        6B in the full report)

        Finding: The resulting strained working relationship between SJGH and
        ECH failed to ensure that best practices in sterilization and IPC
        were implemented in SJGH, despite knowledge that practices there did
        not meet ECH standards. Historically, ECH operated under the
        understanding that they needed to be "invited in" to SJGH to make any
        changes to services and SJGH considered directives from ECH
        "optional".

        Recommendation: Define the relationship between ECH and SJGH in the
        Service Agreement and ensure that the authority, accountability and
        responsibility of regional managers and senior management is also
        clearly defined for quality and safety. (See full report for other
        related recommendations 2A-2D)

    Theme: Pervasive patient safety culture, patient safety advocacy and
organizational alignment of safety, quality, risk management and IPC

        Finding: Lack of a widespread patient safety culture and alignment of
        organizational structure to support patient safety did not allow for
        optimal identification of key safety issues that required immediate
        action at the senior administration and Board levels in both ECH and
        SJGH.

        Recommendation: Actively define and create a culture of safety that
        empowers all staff, managers, administrators, Board members and
        physicians to improve patient-related care using strategies such as
        regular safety culture surveys of staff, regular quality/safety
        rounds, regular (transparent) performance indicator reports,
        administrative walkabouts, routine addition of patient safety and
        quality topics to all meeting agendas, and any other patient safety
        initiatives that would be appropriate. See full report for more
        detail on related recommendations listed below.

        -   Lack of evidence of a strong patient safety culture, patient
            safety advocacy and use of patient safety criteria for making
            decisions in both ECH and SJGH.

            (See also causes and recommendations 4, 4A, 16, 16A, 16B, 16C,
            21, 21A, 21B, 21C, 22B, 22C, 22D)

        -   Lack of alignment of processes and structure to support patient
            safety in ECH.

            (See also causes and recommendations 17, 17A, 18A, lesser extent
            10, 10A-E, 5, 5A-E, 12, 12A, 12B)

        -   Additional knowledge required of SJGH and ECH Boards to
            understand their fiduciary responsibility in patient safety.

            (See also cause and recommendations 18, 18A-G, 18I)

        -   Minimal involvement of SJGH and ECH physicians to influence
            patient safety.

            (See also causes and recommendations 19, 19A, 20, 20B-E)

        -   Lack of engagement of SJGH physicians to communicate the
            seriousness of the MRSA situation and CSR breaches and advocate
            for change perpetuated the continuation of unsafe practices.

            (See also causes and recommendations 19, 19A, 20, 20A)

    Theme: Organizational structure and change management

        Finding: Lack of consistent processes to operationalize policies,
        procedures, directives in SJGH and ECH.

        Recommendation: Develop processes and procedures that utilize
        checklists and feedback mechanisms to communicate and implement new
        and revised policies, procedures and directives and ensure compliance
        to same.

            (See also cause and recommendations 8, 8A-C)

    Theme: Provincial standards including possible legislation

        Finding: Lack of provincial standards in MRSA screening and
        surveillance and other broader infection control best practices,
        standards and guidelines. This is an issue also under serious
        consideration in other provinces - see BC Auditor General's Report,
        March 2007.

        Recommendation: Develop provincial standards for MRSA screening and
        surveillance so all RHAs have consistent practice.

            (See also causes and recommendations 13, 13A, 13B, 15, 15A, 15B);
            See Part 3 for "sterilization" needs.

    Theme: Duty to act on knowledge that may negatively impact patient safety

        Finding: Previous knowledge by ECH dating back to 2004 about
        deviations from standard disinfection methods for endoscopes in the
        SJGH CSR and failure to act resulted in continuation of unsafe
        practices. An internal recommendation to review all endoscopic
        cleaning practices within ECH was not acted upon.

        Recommendation: Any individual who becomes aware of a potential
        safety hazard or probable risk to patient safety is duty bound to
        take appropriate and timely action such as reporting the situation to
        their supervisor or taking appropriate action to resolve the
        situation.

            (See cause and recommendation 22, 22A)

    Part 2: Evaluation of Follow Up Action

        Finding: Chart audits of patients who may have experienced adverse
        outcomes as a result of MRSA or use of surgical instruments that were
        inappropriately cleaned and sterilized in SJGH are in process but
        proceeding slowly.

        Recommendation: Chart audits need to be conducted and with a greater
        sense of urgency. See full report for other related recommendations.

        Additional findings:

        -   A well planned look back for patients potentially at risk for
            infections from inadequately sterilized instruments has
            successfully contacted more than 50% of all patients. A second
            phase of the look back is underway to contact the balance of the
            patients. Infectious disease consultants from Capital Health have
            been involved in the planning phases and will assist in follow up
            of patients identified with communicable disease. (See findings
            and recommendations page 34)

        -   Alberta Health and Wellness and/or the Department of Public
            Health should consider providing leadership and support to
            regions requiring specialized expertise in dealing with critical
            infectious disease incidents. (See findings and recommendations
            page 36)

    Part 3: Tour of ECH Acute Care Sites and Incidental Findings

    A large number of the findings and recommendations support those provided
in Part 1.

    Theme: Leadership and advocacy for IPC and CSR and other safety issues

        Finding: Central Sterilization Room reviews in 11 other acute care
        sites in ECH revealed a spectrum of deviation from the Canadian
        Standards Association standards in all sites. Deviations ranged from
        practices that introduce a source of contamination but are readily
        resolvable (e.g., removal of corrugated cardboard, which may harbour
        contaminants such as fungus) to more serious practices such as
        disinfection versus sterilization of foot care instruments. A review
        of documentation revealed re-use of cautery devices intended as
        single use only items.

        Recommendation: Ensure practices meet CSA standards. See full report
        for detailed listing of required action pages 47, 50-58.

        Additional Findings:

        -   Staffing levels of IPC require review for number and allocation
            to meet current needs of region. ECH should also consider
            formalizing the IPC role by incorporating the expectations into a
            position rather than making it an add-on to an existing full-time
            position. (See findings and recommendations page 46)

        -   IPC and sterilization issues require leadership from both senior
            management and physicians to ensure issues are dealt with at the
            senior level of decision-making. The Region is encouraged to
            identify structure and processes to ensure IPC and sterilization
            issues are aligned and addressed by individuals with relevant
            expertise and authority for action. (See findings and
            recommendations pages 46, 47)

        -   AHW IPC survey revealed self-reported deficiencies in IPC in ECH.
            Survey requires more in-depth review and analysis by ECH and
            Associate facilities to identify an implementation plan for
            addressing deficiencies. (See findings and recommendations pages
            47, 48)

        -   Review of CSR practices acknowledged strengths:

            -   Everyone interviewed was very co-operative and forthcoming,
                and deserves and requires the appropriate ongoing regional
                support.
            -   St. Mary's Hospital in Camrose has accessed a number of
                consultants, uses the Grey Nuns expertise as a resource, and
                has an experience and skill set level among their staff
                resulting in the required knowledge for safe CS practices.
            -   Vermilion has a high level of expertise and has kept up with
                recent practice changes and requirements.
                (See findings and recommendations on page 48)

        -   Standards and best practices in CSR, training of CSR staff and
            CSR training programs are not standardized within the province or
            country and provincial leadership is necessary to ensure safer
            practices. Qualifications of CS processors need to be confirmed
            and accreditation of training programs may be an option to be
            explored. (See associated findings (Part 1) page 15 and findings
            and recommendations (Part 3) page 59)

    Theme: Organizational structure and change management

        Finding: Lack of clarity of roles and lack of input of local sites
        into regional planning.

        Recommendation: Opportunities exist to enhance the regional approach
        to services in ECH. ECH should clarify roles and include input of
        local sites into regional planning using a population-based approach
        and have clear understanding of allocation of services and use of
        relevant resources. The role of St. Mary's Hospital in Camrose with
        respect to clinical leadership needs to be clarified. (See findings
        and recommendations page 42)

        Additional Findings:

        -   Appropriate orientation, application of external education and
            training, and ongoing support must be provided to individuals in
            management and supervisory positions to ensure knowledge of
            expectations and responsibilities and their ability to meet those
            expectations. (See findings and recommendations page 43)

        -   Comparative data on safety and quality needs to be shared across
            the region to address required improvements. (See findings and
            recommendation page 44)

        -   Communication style of ECH requires review to ensure adequate
            input in decision-making, feedback for confirmation of
            understanding of message and required follow up, appropriate
            delegation of authority and use of change management strategies.
            (See findings and recommendations page 45)

    Theme: Role of and implications for external quality and safety reviews

        -   External reviews of safety and quality practices have a spectrum
            of value depending on approach, expertise and processes used.
            Health Facilities Review Committee process lacks the depth
            required to make generalized assessments of quality. Canadian
            Council on Health Services Accreditation (CCHSA) report
            underscores the importance of confirming self report with
            evidence. While there is significant value in the self-assessment
            process, evidence for compliance with standards at each site in
            the region must be provided or looked for by the surveyors. CSR
            may be considered as an area for mandatory review by the
            surveyors. Relevant findings from the SJGH Operational Review
            (Blackwell & Associates) aligned with this investigation. (See
            findings pages 59-65)

    Theme: Role of the Medical Officer of Health

        -   There is a need to review the role of the Medical Officer of
            Health as it relates to patient safety. At what point does
            patient safety, normally an operational responsibility, become a
            public safety issue and require the legislative authority of the
            Public Health Act to achieve immediate attention? (See associated
            findings (Part 1 page 15 and findings (Part 3) page 66)

For further information: Pam Brandt, Communications Lead, Health Quality
Council of Alberta, (403) 297-8162, (403) 850.5067 (cell)