Risk and opportunity management within SANBS

SANBS embraces risk as an essential enabler for setting and achieving its strategic objectives and purpose of being ‘Trusted to Save Lives’

Risk Governance

How SANBS manages risk and opportunity

SANBS has established risk management as an integral component of business processes.

Risk management is governed by an Enterprise Risk Management (ERM) Framework which provides a solid foundation to guide the organisation in embedding structured risk management processes to deliver sustained value.

Through the ERM process, risks and opportunities, which could affect the achievement of our iHEALTh strategy, are identified and managed within defined risk appetite and tolerance levels set by the Board. Management decisions to tolerate, treat, terminate or share risks and opportunities are taken based on these parameters.

As an essential health service provider of blood products and services, it is prudent that SANBS protects its donors and stakeholders from the potential adverse effects of risk and has therefore adopted a conservative risk approach.

SANBS follows an iterative and dynamic risk management process to ensure ongoing identification and evaluation of risks and opportunities in response to a continually evolving and rapidly changing internal and external environment. Risks and opportunities are also identified through stakeholder engagement.

Oversight of risk management is the responsibility of the Risk, Technology and Information Governance Committee. See our RTIG Committee.

Notable for 2021

Our material matters are reflected in our key risks and opportunities and represent the issues that have the most impact on our ability to create sustainable value for our stakeholders and influence our business model. Read more about our Material Matters page.

Of significance, as reported during the previous reporting period and until the date of this report, is the management of the risks associated with the Covid-19 pandemic, as well as the management of the impact on blood supply during the recent unrest in KZN.

Risk management continued to play a major role to ensure continuity of operations in response to these events by:

  • Continuing with the use of the crisis communication plan to communicate responsibly to SANBS staff and external stakeholders
  • Monitoring and managing risks and opportunities associated with execution of the iHEALTh strategy, in these unprecedented circumstances
  • Maintaining a Covid-19, and recently an unrest risk monitoring dashboard, for oversight and monitoring by the identified task team, Executive and Board

See focus of Risk, Technology and Information Governance Committee on the link and details of Risk and Opportunity Management below:

Managing our risks and opportunities to ensure we manage what matters most

BENEFITS DERIVED FROM PRACTISING GOOD RISK MANAGEMENT

NAVIGATING THROUGH A YEAR OF CRISIS AND CONFIDENTLY PAVING THE WAY INTO THE FUTURE

Our ERM framework is premised on global practical risk management practices including ISO31000 and King IVTM, and includes the identification, analysis, evaluation, treatment and monitoring of risks and opportunities from a position where we understand the context of our internal and external business environment and impact on our iHEALTh strategy.

Figure 1, demonstrates how the effort is driven by the Board, senior and middle management to manage and report on risks.

Figure 1

Figure 2: Risk management and risk reporting process

In addition, all lines of assurance are included (» See link), as part of the Board Committee oversight to ensure that roles, responsibilities and accountabilities for risk are clearly defined. See Figure 2.

CURRENT AND ONGOING FOCUS AREAS

Pre-empting and managing impacts caused by the Covid-19 pandemic

Two external events that initiated additional risk identification included:

  • Current supply chain controls were enhanced to mitigate any negative impacts on the critical consumables and equipment supply chain, especially where suppliers were situated in China
  • Management recognised that the lack of an overarching business continuity management process could negatively affect sustainability and resulted in the formalisation of a crisis communication plan, which was timeously implemented at the start of the pandemic
Implementation of iHEALTh
  • This included management’s continued monitoring and management of changes to the risks in the context of SANBS’ operating environment while implementing iHEALTh strategies to digitalise and improve personalised donor care using artificial intelligence and other operational improvement opportunities. Changes in the work environment were implemented using a risk based approach for work-from-home practices, as well as Infection Prevention and Control (IPC) measures, remote learning and remote monitoring of compliance to Covid-19 regulations
Blood establishment computer system project management
  • A key step in the management of the Blood Establishment Computer System (BECS) implementation continues to be the monitoring of risks and opportunities that may impact the successful implementation of the new system
SANBS RISK PROFILE (RISK HEATMAP OF TOP RISKS)

The residual risk level of strategy level risks currently identified and managed is depicted in the heatmap below:

Likelihood

RISK PROFILE TREND

FY2021 TOP RISKS

STRATEGY LEVEL RISK/OPPORTUNITY KEY CAUSES, CONTROLS AND RISK TREATMENTS
Year-on-year fluctuation Increase Decrease Same New
Risk
Key Causes
Key Controls

Inability to attract and retain appropriately skilled and competent people at the right place and at the right time

iHEALTh
Capital
  • Loss of business imperative staff to local and international healthcare organisations
  • Certain areas where leadership skills not fully developed
  • Staff injuries
  • Poor performance management and succession planning
  • Changes in staff requirements due to an automated work environment
  • Unions, and misaligned expectations
  • Changing staff expectations
  • Staff shortage due to Covid-19
  • Staff compliment is per approved organisational structure with business imperative roles are prioritised and appointments are made on a Fixed Term Contract basis, when required
  • Talent Management and succession planning to ensure suitably qualified employees are readily available
  • Accelerated recruitment and rapid redeployment processes, to ensure timely recruiting
  • Performance management to ensure fit-for-purpose development of staff
  • Health and wellness incidents monitored by the Occupational Health Department
  • Competitive remuneration through benchmarking
  • Impact analysis and planning for staff and skills requirements are integrated into process change and process automation projects
Key risk treatment actions
  • Continue monitoring staff availability through the Covid-19 Reaction Unit to ramp up re-deployment when required
  • Monitor DNA formula culture change after initial launch to ensure negative indicators reduce and positive indicators increase
  • Succession planning and talent management linked to the 360° assessment
  • Finalise immersive leadership training including key improvement elements identified during 360 review
  • Finalise organisational realignment project
  • Improve flexible working environment, specifically focusing on work-life-balance
Covid-19 impact
  • Critical/business imperative staff and staff wellness monitoring by the Covid-19 Reaction Unit
  • Plans to ensure continued operations and donor safety by sufficiently qualified/trained/retrained staff
STRATEGY LEVEL RISK/OPPORTUNITY KEY CAUSES, CONTROLS AND RISK TREATMENTS
Year-on-year fluctuation Increase Decrease Same New
Risk
Key Causes
Key Controls

Inability to meet all demand for all blood products

iHEALTh
Capital
  • An ever increasing SA population and high numbers of euthemecia/cancer patients who require large volumes of blood
  • Prolonged procurement process
  • Lockdowns which prevented donor centres from operating effectively
  • SANBS’ decentralised business model across SA to ensure availability of required blood stocks
    • Supported by monitoring demand and collection targets set and managed at Executive and Board level
  • PBM, demand management and clinical trials to improve donor and patient care
  • Procure and implement Smart Fridges to improve coverage of blood availabilty
  • 'Project #IronStrong' to decrease deferrals and offering of iron tablets to eligible donors
  • Optimising of donor return rate through #DonorOptimisation and integration/conversion of Groups A and AB donors into sourced plasma donors to assist NBI with their plasma supply requirements
Key risk treatment actions
  • Research into cell salvaging to reduce the need for blood
  • Digitalisation of personalised donor care including implementation of a modernised BECS
  • Further development of the predictive Blood Demand Model
  • Further improvements to PBM and donor mobility to enhance donor and doctor engagement
  • Drone programme to transport emergency blood products
Covid-19 impact
  • Collections are closely monitored and 'Day’s cover' is holding steady
  • Possible increase in requirements for blood is closely monitored to ensure timely planning when an increased demand is expected
STRATEGY LEVEL RISK/OPPORTUNITY KEY CAUSES, CONTROLS AND RISK TREATMENTS
Year-on-year fluctuation Increase Decrease Same New
Risk
Key Causes
Key Controls

Inability to remain financially sustainable

iHEALTh
Capital
  • Revenue collection continues to be challenging as both Public and Private hospitals are under severe budgetary pressure
  • A Debtors Collection Task Team expedites collections through continual engagement with stakeholders
Key risk treatment actions
  • Improvement of invoice submission processes to ensure accurate first submission
  • Automation of a number of processes to simplify reconciliations of accounts between SANBS and its debtors
  • Focus on further development of additional revenue streams
Covid-19 impact
  • Focus on costs; reduction in total collections from R3.83bn to R3.58bn (7% decrease YoY)
STRATEGY LEVEL RISK/OPPORTUNITY KEY CAUSES, CONTROLS AND RISK TREATMENTS
Year-on-year fluctuation Increase Decrease Same New
Risk
Key Causes
Key Controls

Failure to provide and maintain stable information management systems

iHEALTh
Capital
  • Failure of information security (including Cyber-attacks, etc)
  • Prolonged downtime of critical systems
  • Insufficient computing resources to enable operations
  • Failure of operational systems, including medical equipment software components interfacing with IT systems
  • Non-compliance with information governance policies and related legislation
  • ISMS to ensure that only authorised access is provided to people/systems
  • Regular review and improvement of IT solutions to ensure continued availability, integrity and sufficient protection of sensitive information, and to stay abreast of technology that will improve business processes
  • Information management system lifecycle management including updating in terms of threats (viruses) to solutions
  • Disaster recovery plans that include a fixed schedule for continuous monitoring
  • Information governance policies and processes to ensure continued compliance with legislation regulating to use of information
Key risk treatment actions
  • Implement a modernised BECS system
  • Information governance process improvements throughout the organisation
Covid-19 impact
  • IT systems are performing well under the stressed situation and a remote working environment is in place and performing well during Covid-19
STRATEGY LEVEL RISK/OPPORTUNITY KEY CAUSES, CONTROLS AND RISK TREATMENTS
Year-on-year fluctuation Increase Decrease Same New
Risk
Key Causes
Key Controls

Ability to maintain R&D leading to new products/new solutions and new income streams (Opportunity)

iHEALTh
Capital
  • Increased healthcare possibilities that involve blood and blood derived products
  • Increased requirements from market
  • Increased research globalisation
  • Increased need for collaborations across varied field
  • Lack of skilled, experienced staff
  • Lack of Rewards and Recognition programme
  • Lack of protected time for research
  • Insufficient budget allocation
  • SANBS’ Research Policy and Governance Framework
  • SANBS Research Agenda
  • Dual Career Pathway Policy
  • Translational Research Office
  • SANBS Grants Management Office (needs further development)
  • SANBS Graduate Support Programme
  • Scientific Review Committee
  • Human Research Ethics Committee
Key risk treatment actions
  • JACIE FACT accreditation for Cellular Therapy and ASHI/EFI accreditation for Tissue Immunology. JTFAEC course offered across sector
  • Increase staff with clinical trial level research knowledge and experience
  • EFI accreditation
  • Implement Dual Career Pathway policy
  • Implement Graduate Support Programme
  • Ensure sufficient funding for research related activities in SANBS
Covid-19 impact
  • Covid-19 stunted growth of our alternative revenue stream but strong recovery is likely once the pandemic abates
  • Capacity building over the years enabled SANBS to meaningfully contribute to the national and international research efforts aimed at better understanding and managing Covid -19
  • SANBS, Western Cape Blood Service and DSI-NRF Centre of Excellence in Epidemiological Modelling and Analysis performed a sero-surveillance study where 17 000 blood donors were tested to estimate the prevalence of antibodies to SARS-COV-2 indicating past exposure to the virus
STRATEGY LEVEL RISK/OPPORTUNITY KEY CAUSES, CONTROLS AND RISK TREATMENTS
Year-on-year fluctuation Increase Decrease Same New
Risk
Key Causes
Key Controls

Compromised safety and quality of blood products

iHEALTh
Capital
  • Donor health and wellness issues
  • Lack of transfusion medicine and PBM knowledge of doctors
  • New and re-emerging pathogens that are not tested for
  • Breakdown or failure in QMS
  • IPC management
  • Insufficient medical oversight of the Core value chain
  • Inability to influence private sector stakeholders

To note: Currently there is no proof that Covid-19 is transfusable

  • Strong and robust QMS continually monitored by Quality Department
  • Strong Compliance management processes
  • IPC & PPE measures introduced at all collections sites
  • Donor health and wellness programmes
  • Education and hospital support programmes
  • PBM initiatives
  • Socio-economic/skills development initiatives including health care and public stakeholders and SANBS staff
  • Automated processes (limited)
  • Business continuity process (in the process of being improved)
Key risk treatment actions
  • Develop revised platelet strategy in line with decision to postpone possible implementation of PRT by 2 years (deferred for cost reasons)
  • TTI risk monitoring
  • Finalise implementation of the #IronStrong project
  • Quality management monitoring
  • Improve BCM in the Reagents lab
  • Lead PBM implementation in South Africa
  • Lobby private healthcare funders to influence private sector HCW
  • Plan and roll out Healthcare worker education
Covid-19 impact
  • Continued monitoring of global research by the Covid-19 Reaction Unit to monitor effects and to put plans in place if any changes occur
  • Covid-19 team and other SANBS staff monitor research into Covid-19 effects continuously
STRATEGY LEVEL RISK/OPPORTUNITY KEY CAUSES, CONTROLS AND RISK TREATMENTS
Year-on-year fluctuation Increase Decrease Same New
Risk
Key Causes
Key Controls

Uncertainty as to the impact of the National Health Insurance (NHI) implementation on SANBS operations

iHEALTh
Capital
  • Legislative compliance required
  • Not all SANBS processes may be aligned with potential legislative requirements
  • Cost structures not able to absorb possible pricing requirements
  • Inability to cost different pricing models
  • Input and guidance is provided to developers of the legislation by Board and Management team, where appropriate
  • Continuous review of requirements to timely align SANBS’ business model
Key risk treatment actions
  • Board and management provide, through ongoing engagement and where appropriate, input and guidance to developers with the National Department of Health and other stakeholders
  • In anticipation of requirements, implementation of ‘ISO 15189:2012 Medical Laboratories – Requirements for Quality and Competence’ is underway
Covid-19 impact
  • No significant impact on the key risk treatment actions used to manage the risk
STRATEGY LEVEL RISK/OPPORTUNITY KEY CAUSES, CONTROLS AND RISK TREATMENTS
Year-on-year fluctuation Increase Decrease Same New
Risk
Key Causes
Key Controls

Internal and external events may compromise the SANBS brand

iHEALTh
Capital
  • People elements such as historical issues negatively affecting staff morale and poor communications, such as:
    • Stakeholders sharing unconfirmed information
    • Data breaches
    • Patient/doctor/ hospital dissatisfaction, leading to negative media coverage
    • Dissatisfaction of external stakeholders
    • Legal action
    • Inefficient handling of incidents or crises
  • Use of external reputation management service provider when specialist support needs arise (VUMA)
  • Automated, continuous scanning of social media environment to ensure: any comments negative comments are mitigated and positive comments are capitalised on
  • Proactive identification of stakeholders at planning and during projects to ensure sufficient change management takes place
  • SANBS strives for a strong ethical environment
Key risk treatment actions
  • Continued implementation of an organisational culture renewal initiative (DNA) through which staff identified issues and developed actions to improve morale » Go to link
  • Implementation of the Ethics Institute’s recommendations after their review of the ethical environment in SANBS
Covid-19 impact
  • Covid-19 communication to staff and stakeholders is closely monitored to ensure blood and blood products’ supply is maintained
STRATEGY LEVEL RISK/OPPORTUNITY KEY CAUSES, CONTROLS AND RISK TREATMENTS
Year-on-year fluctuation Increase Decrease Same New
Risk
Key Causes
Key Controls

Non-compliance with regulatory requirements

iHEALTh
Capital
  • Legislative Compliance
    • Onerous and changing national legal system
    • Insufficient knowledge
    • Insufficient resources
    • Increased instances in society of litigation against organisations and management
  • Medico legal compliance
    • Medico legal risks where SA is rapidly becoming a more litigious society which makes SANBS vulnerable even when every effort is made to follow policy and procedures to ensure safety
  • Human error remains a key cause
  • Approved Compliance Framework developed in line with the General Accepted Compliance Principles Framework (GACP)
  • Compliance office staffed with a qualified Compliance Officer and formally appointed compliance champions in all departments, meet monthly, to ensure that legislation relevant to individual business areas is updated and continually complied with
  • SANBS employs medical practitioners that oversee operational compliance
  • Monitoring of the regulatory landscape to identify new/changing requirements impacting the established compliance universe
  • Exclaim compliance management software solution, populated and continually updated with pre-identified legislation/regulations that SANBS is required to comply with, is used to facilitate monitoring of compliance
  • Non-conformance identification process allowing stakeholders to log non-conformances whereafter consequent management is done and improvement steps are identified and implemented
  • Compliance reviews by SANBS’ Compliance Function to ensure continued compliance
  • Internal Quality Department performs quality control audits to monitor compliance
  • SANAS compliance reviews with implementation of improvement recommendations
  • Medmal insurance with reporting of possible claims through a lookback process on any event that could result in possible non-compliance claims
Key risk treatment actions
  • Continued monitoring of the SAHPRA environment to ensure early identification of possible impacts on SANBS
  • Increase Haemovigilance / surveillance by reducing Hospital Clerical Error Rate
  • Finalise the formalisation of the Information Governance process
  • Finalise the review of the compliance universe included in the Exclaim solution to include all core and secondary legislation
Covid-19 impact
  • Frequently changing Covid-19 regulatory requirements are monitored by the Covid-19 Reaction Unit lead by the Medical Director