Report of the Investigation Into Northfield Vaccination Incident

Report of the Investigation into Northfield Vaccination Incident

Final

5th June 2007

Distribution

1. Aberdeen City CHP Clinical Governance Group
2. Northfield/Mastrick Medical Practice
3. NHS Grampian Clinical Governance Committee
4. Aberdeen City CHP Senior Operational Management Team
5. Aberdeen City CHP Risk Management Operations Group
6. NHS Grampian Operational Management Team
7. Aberdeen City CHP Committee

The Aberdeen City CHP and NHS Grampian Groups/Committees are asked to:

• Note the content of this report.
• Accept the report.
• Influence the recommendations through the identification of how actions will be implemented and by whom.

Contents

Executive Summary Page 3

Methodology of the Investigation Page 4

Analysis Page 5

Root Causes and Contributory Factors Page 5

Good Practice Page 6

Recommendations Page 6 / 7

1. Executive Summary

On the 26th September 2006 it was brought to the attention of senior nursing and administration staff within the Northfield/Mastrick Medical Practice that there was a problem with the storage temperature of vaccines. The World Health Organisation (WHO) states that vaccines must be stored between 2 and 8C to maintain their potency.

An initial assessment of the incident by the Practice staff identified a potential malfunction of the fridge within the Treatment room on the Northfield site. As a precaution and following advice given, the Practice returned the vaccines stored in this fridge to Pharmacy due to their unknown potency. The vaccines were subsequently destroyed. Following escalation of the incident and further investigation by NHS Grampian, the vaccination programme was subsequently suspended. A plan to assess the need for re-vaccination for more than 800 patients was initiated. Whilst the failure of the fridge was a precipitating factor, the decision to re-vaccinate was made due to temperature recordings being incomplete and outside acceptable limits on a significant number of dates over the preceding two years providing no assurance of maintenance of the cold chain.

A root cause analysis approach was used for the investigation of this incident. This was to ensure a systems-based approach to identifying root causes as advocated by the National Patient Safety Agency and NHS Quality Improvement Scotland.

Interviews were conducted with clinical and senior administration staff at the Practice to establish the factual events surrounding the occurrence. The investigation team then considered the root causes and has made recommendations to reduce the risk of recurrence.

Key Finding

It is the considered view of the investigation team that the root causes of this incident are a combination of systematic failures.

None of these failures were in isolation the main cause of this incident; however a lack of understanding of the significance of the temperature control processes was evident.

2. Terms of Reference for the Investigation Team

An investigation was commissioned by Heather Kelman, General Manager of Aberdeen City Community Health Partnership (CHP) on the 20th November 2006 to identify actual events, the root causes and any recommendations required.

The Chief Pharmacist through the establishment of a NHS Grampian (NHSG) Vaccine Storage Action Group is directing revisions to NHS Grampian's procedures for vaccine storage in light of this incident. This group has developed a programme of actions including the need for training for both pre-registration and registered practising nurses that will improve the safe storage and handling of vaccines.

The investigation team's remit did not extend to the re-vaccination programme.

3. Membership of the Investigation Team

A team was established to undertake the investigation. This comprised senior managers with a clinical background who had no direct involvement with the management of the Northfield/Mastrick Medical Practice. The team was supported by the Clinical Governance and Risk Management Support Units of NHSG who are trained in Root Cause Analysis provided by the National Patient Safety Agency (NPSA) and organised by NHS Quality Improvement Scotland (NHS QIS). A root cause analysis approach was used for the investigation to ensure a systems-based approach was used in identifying the root causes.

4. Nature of the Incident

On the 26th September 2006 it was brought to the attention of senior nursing and administration staff within the Northfield/Mastrick Medical Practice that there was a problem with temperature control of vaccines. The World Health Organisation (WHO) states that vaccines must be stored between 2 and 8°C to maintain their potency.

An initial assessment of the incident by the Practice staff identified a potential malfunction with the Treatment room fridge on the Northfield site which led to the destruction of vaccines due to their unknown potency. The failure of the fridge was a precipitating factor. Of greater significance however, was the discovery of incomplete temperature recordings, which were also outside acceptable limits from October 2004 to the time of the incident. Stored records were able to identify a period (two years previous to October 2004) when the fridge temperatures had been consistently within the approved range.

5. Consequences of the Incident

Following further investigation by NHS Grampian into the unknown vaccine potency, the vaccination programme at the Practice was suspended and advice sought from the Public Health Department Health Protection Team leading to the formation of an Incident Management Team (IMT). The IMT subsequently directed a plan to re-vaccinate more than 800 patients as a precautionary health protection measure.

6. Nature of the Investigation – Root Cause Analysis Tools Used

Interviews were conducted as recommended by the National Patient Safety Agency.

An initial working document of the report was distributed to those interviewed for comment on factual accuracy.

7. Analysis

1. At the time of the incident there were a range of relevant NHS Grampian Patient Group Directives (PGD) and the current Vaccine Policy available at the Practice.

2. There was a robust system in place for ensuring all staff administering vaccines signed up to the PGDs on an annual basis. Exceptions to compliance are flagged up to the relevant Service Manager.

3.There was a fundamental lack of understanding of the importance of the cold chain, why temperatures have to be recorded and the importance of the minimum/maximum re-setting process.

4.It was clear that not all clinical staff involved in the provision of immunisation had seen or achieved a practical understanding of the Vaccine Policy.

5. There was no evidence of action taken to ascertain whether any changes to existing practice were required in light of Vaccine Policy revision issued in July 2005.

6.There was delay in submitting the Occurrence Recording form due to collating more details; lack of knowledge regarding assessment of significance of the event.

7.The current management arrangements for salaried practices in NHS Grampian do not provide clear lines of accountability and responsibility particularly between staff disciplines.

8 Root Causes Identified

“A root cause is the cause or causes that, if addressed, will prevent or minimise the chances of an incident recurring. Though the term can imply there is a single root cause, typically there are often a number of aspects to the incident which, if they were rectified, may have prevented the incident from occurring.” (Reference; National Patient Safety Agency; Seven Steps to Patient Safety for Primary Care September 2005)

1. Lack of understanding of the significance of PGDs and the Vaccine Policy in relation to the cold chain and their implications for current practice.

2.Failure to act on temperatures recorded out-with the limits that would call into question the potency of the vaccines as per the PGDs/Policy.

9. Good Practice Identified

Some of the nursing staff referred to what they felt was a thorough process regarding the peer observation of the actual procedure of giving vaccinations.

There is evidence of a high level of childhood vaccination compliance rates - especially given the socially deprived nature of the Practice catchment area.

Staff referred to an excellent level of communication regarding patient specific case management within the Practice team – this process could be built upon to address issues of education and policy implementation.

There is evidence of good clinical outcomes in an area of socio-economic deprivation as evidenced by the recent Quality and Outcomes Framework (QOF)[*].

Following the establishment of the Incident Management Team, the Practice took steps to develop an internal policy for vaccine storage that included the identification in each patient record of the source of any vaccine administered in order that the cold chain is fully traceable.

10. Recommendations

Some of the recommendations made are not only relevant to Northfield/Mastrick Medical Practice but to all areas within NHS Grampian. It should be noted that some of these recommendations have been further developed through the review of the Vaccine Policy and the work of the NHSG Vaccine Storage Action Group.

1. Develop guidance / templates, directly involving front line experienced staff that include safety and quality aspects relevant to their area of work for local induction for all staff. The links to Knowledge and Skills Framework should be considered as part of this and on an ongoing basis thereafter.

1. Review and update the PGDs and Vaccine Policy to include greater profile given to the temperature requirement, frequency of recording, necessity to re-set minimum/maximum thermometer and transportation of vaccines by NHSG staff. Consider need to record visual verification of within limits temperature logs prior to vaccination.

1. Review the temperature recording template within the Vaccine Policy to include the necessity for daily recording, specify the minimum and maximums, requirement to re-set minimum/maximum device and specify action to be taken if the minimum/maximum is exceeded. (This links to the work of the NHSG Vaccine Storage Action Group)

1. A process to be designed to ensure designated senior staff (e.g. Practice Manager, specified GP and Team Leader) are disseminating, implementing, monitoring and reviewing to ensure compliance with agreed policies and procedures.

1. Staff attending meetings need to disseminate relevant information to those staff that they represent to ensure staff are adequately informed and all staff rely on those attending to raise important issues with other members of the practice.

1. PGDs and new policies relevant to the area of practice should be introduced at team meetings to evidence discussion and understanding of the content and implications for practice and to raise training issues/needs where these arise.

1. Individual performance appraisal should happen on a regular basis to ensure concordance with required standards. Senior nursing and administration managers within the CHP should directly oversee this. By this means and in conjunction with active performance review, proactive management and leadership skills can be developed for key personnel within the Practice to ensure effective management of a dispersed staff group.

1. Actively manage recovery of the Practice from the incident ensuring remedial actions are implemented and confidence restored within the staff group.

1. CHP to consider development of patient safety audits to spot check on a rolling basis issues arising from and being informed by the relevant Clinical Governance and Risk Management structures within NHSG e.g. from incidents reported, complaints received.

1. Process to be designed to ensure designated senior staff (e.g. Practice Manager, specified GP, and Team Leader) are monitoring and reviewing to ensure compliance with agreed policies and procedures.

1. Review the management arrangements for salaried practices ensuring clear lines of accountability between medical staff, admin/practice staff and nursing staff with clear schemes of delegated authority. This applies both within the Practice and between the Practice and NHS Grampian (Aberdeen City CHP).

1. NHSG to consider preparation for clinical policy development that can evidence front line staff involvement in the process. This should be extended to include front line staff in the review and updating of policies.

1. Risk Management to consider as part of imminent re-launch of the Occurrence Recording system the ability to report early and add details as they become available, the necessity to consider escalation to senior management for significant events and quarantining of equipment to allow investigation.

1. Having a Clinical Governance team attached to each CHP will assist an audit of policy dissemination and understanding.

1

[*]QOF is a measure of clinical and organisational achievements in medical practices