Part 3: Ensuring that blood and blood products are safe

New Zealand Blood Service: Managing the safety and supply of blood products.

3.1
In this Part, we discuss how the Blood Service manages the safety of blood and blood products by:

Our overall finding

3.2
Safety is the cornerstone of the Blood Service's operations. The Blood Service has systems and controls to manage the safety of donated blood and processed blood products in all aspects of its operations.

Assessing and managing risks

The Blood Service uses a suitable framework to assess and manage risks to the supply of blood and blood products.

3.3
As part of its policy7 for assessing significant risks, the Blood Service uses a matrix to help work out how likely an adverse event is and what its consequences might be. The policy sets out the governance structure for managing risks. It also assigns responsibilities and accountabilities within the Blood Service for assessing and mitigating identified risks.

3.4
The Blood Service's framework for managing risks has five components. These are:

  • the policy – setting out how to define, report on, and monitor risks;
  • assessing risks – in line with "Safety is our cornerstone", with a formal process throughout the Blood Service's operations for reporting and dealing appropriately with significant incidents;
  • defining and ranking risks – scoring risks against how likely they are, their consequences, whether they are strategic or operational, and whether they concern safety, supply, or the sustainability of the business;
  • monitoring, managing, and controlling risks – using a risk register and regularly monitoring compliance with policies, standards, and legislative and regulatory requirements; and
  • reporting and review – including the Blood Service Executive Team's formal quarterly review of the risk register and the Blood Service Board's quarterly review of the "top 10" risks and all identified "high" or "very high" risks in the risk register.

3.5
The Blood Service's framework for managing risks is particularly strong in dealing with significant incidents that have the potential to become major risks. Every quarter, the Blood Service's Executive Team and Board receive a summary report of incidents that have been escalated for their attention. Relevant managers consider how to mitigate the risks. The Blood Service adds recurring escalated incidents to its risk register.

Screening donors

The Blood Service effectively screens all prospective blood donors.

Safety standards

3.6
Screening prospective donors is the first line of defence in managing blood safety. Screening helps to assess whether prospective donors are healthy and fit to donate blood, and helps to protect patients from infections, diseases, and adverse reactions to donated blood. The Blood Service identifies low-risk donors by learning about their behavioural and medical history.

3.7
The Blood Service uses strict standards to collect blood and guide how it screens people who donate blood. Appropriately, the Blood Service focuses on the safety of donors and the blood that it collects.

Screening process

3.8
A standard Donor Session Record form must be filled in every time a person presents to donate blood. A registered nurse interviews all prospective donors. The Donor Session Record contains a clear and detailed questionnaire about the interviewee's eligibility to donate blood and appropriate requirements for donors to confirm that they understand the session record's content. Prospective donors must sign a declaration stating that the information they provide is correct and accurate. The criteria that the Blood Service uses to assess eligibility to donate follow international best practice.

3.9
Effective checks identify donors and ensure that the Blood Service correctly links session records to donors and to blood products resulting from donations. For example, staff at collection sites:

  • ask to see appropriate forms of personal identification; and
  • interview donors to verify information in the donor's session records.

3.10
It is important to interview people preparing to donate blood. Staff at collection sites must have effective interpersonal skills because they must sometimes ask sensitive questions or explain tactfully to some would-be donors why they cannot donate blood. Effective interviewing skills are an important part of competency training for staff at collection sites. We observed that the training for donor selection interviews emphasises the importance of ensuring safety and making people feel at ease about donating blood (or being turned down). A rigorous competency assessment requires new staff at collection sites to successfully complete 15 interviews while an assessor watches.

Collecting blood safely

The Blood Service uses detailed and thorough procedures to ensure the safety and care of donors when it collects blood.

Procedures for collecting blood safely

3.11
These Blood Service's procedures for collecting blood include:

  • training the registered nurses, enrolled nurses, and registered donor technicians who collect blood to observe donors during and after collecting blood, and to deal with any adverse reactions or events;
  • using a reporting system to record all serious incidents; and
  • enforcing strict hygiene standards and procedures while collecting blood.

Quality control

3.12
The Blood Service exercises strong internal and external quality control to safeguard the collecting and manufacturing of blood and blood products and to reduce the risk of unsafe blood products reaching patients. This quality control includes:

  • the Blood Service's Quality Systems staff auditing the activities of all the Blood Service's departments, blood banks that the Blood Service runs, and aspects of manufacturing blood products from collecting to delivering (including testing, storing, and transporting);
  • Medsafe auditing the Blood Service's manufacturing and collections against internationally developed standards and the Code of Good Manufacturing Practice; and
  • IANZ auditing the Blood Service's laboratories and blood banks.

3.13
In paragraphs 3.15, 3.23-3.27, and 3.31, we discuss how Medsafe and IANZ assess and regulate the Blood Service.

Testing blood donations

The Blood Service tests all the blood donated to ensure that it is free of infectious diseases.

3.14
Blood is a biological resource. The Blood Service cannot eliminate all risks to recipients from infection, contamination, or adverse reaction. As discussed in paragraph 3.6, the Blood Service seeks to use only low-risk donors, whom it identifies through screening. Another vital measure to minimise risks is to test blood donations for infectious diseases.

3.15
The Blood Service tests every blood donation to confirm blood type, check for red cell antibodies, and screen for infectious diseases, including HIV, hepatitis B and C, and syphilis. The Blood Service tests donations in line with the Blood Service's manufacturing standards, which Medsafe approves.

3.16
The Blood Service has appropriate controls to ensure that it tests all donated blood. The Blood Service's computer system stops blood products from being labelled and released until it has completed all testing and has electronically collated and validated the results and medical information.

Tracking blood donations

The Blood Service can readily track all blood components (such as red blood cells or plasma) and blood products from donor to recipient.

3.17
The Blood Service uses Progesa, a comprehensive computer system, to manage blood donations by:

  • storing all data about donors, donations, and patients, including donation history;
  • recording the results of donation and cross-matching tests;
  • tracking and controlling the movement of blood product stock;
  • recording when it supplies blood components and products to patients; and
  • providing the data it needs to recruit donors and correctly invoice hospitals for the blood products they receive.

3.18
By using Progesa in all its operations, the Blood Service can trace and recall any donated blood or blood product at any stage of the processing if there are concerns about safety.

Being prepared for disruptions to operations

The Blood Service has adequate contingency plans to protect and maintain its operations in the event of a major disruption to its system for managing blood.

3.19
Relying on Progesa throughout all stages of the vein-to-vein service means that it is vital that the Blood Service has plans to continue business when there are unplanned disruptions to its operation (for example, major malfunctions or natural disasters).

3.20
The Blood Service has adequate contingency plans to protect its operations in the event of major problems with Progesa. These include being able to switch to other computer servers in different parts of the country if its server were to fail. In addition, as part of standard operating protocols with district health boards (DHBs), the Blood Service regularly distributes an antibody database to hospitals. Therefore, hospital blood banks would have historical information about patient antibodies if Progesa were unavailable.

3.21
If there is a disaster or major malfunction of Progesa, the Blood Service has documented manual processes for:

  • collecting, processing, and testing donations of blood components; and
  • cross-matching and issuing blood and blood products to patients.

Quality control, accreditation, and compliance with regulations

The Blood Service has effective systems and quality control to ensure that it safely converts blood into blood products. Blood Service staff and external agencies regularly scrutinise the operations of the Blood Service, which consistently maintains the accreditation it requires and complies with regulations.

3.22
The Blood Service uses National Collection and Manufacturing Standards to specify the technical requirements for the collecting, making, distributing, and storing of blood components and products. An internal Quality Systems team, which conducts regular audits across all operations of the Blood Service, monitors how the Blood Service adheres to the standards.

3.23
The Blood Service has ensured that it complies with good manufacturing practice by consistently maintaining Medsafe licences. The Blood Service is required to maintain these licences at all its sites where blood is processed and made into blood products. Every year, Medsafe audits each site against the Code of Good Manufacturing Practice.

3.24
We reviewed a small sample of Medsafe site audit reports and found that the results were highly favourable towards the Blood Service. Medsafe had identified only minor problems that, in our view, had no material bearing on how safe operations at the sites were.

3.25
Each year, International Accreditation New Zealand (IANZ) issues accreditation certificates to the Blood Service's diagnostic laboratories after its assessors survey the laboratories and the Blood Service carries out any corrective actions required. The Blood Service has met all the requirements for maintaining IANZ certificates for its laboratories.

3.26
The Blood Service has high operating standards in its diagnostic laboratories. In recent years, IANZ has identified few corrective actions for the Blood Service to take, at only a couple of sites. Since 2009, IANZ has not required the Blood Service to take any corrective action.

3.27
The Blood Service responds well to the findings of external quality assurance scrutiny. It formally responds to all Medsafe and IANZ recommendations, detailing the action it has taken or stating reasons for not acting. The Blood Service notes any concerns that IANZ has about its system for managing quality and assigns staff to address those concerns. This shows that, where relevant, the Blood Service acts on the recommendations of independent quality assurance inspectors to improve how it operates.

Best practice and safety in transfusion medicine

The Blood Service contributes to good transfusion medicine practices and the safe use of blood products.

Analysing adverse reactions

3.28
The Blood Service collects reports on adverse reactions in donors and recipients as part of a national haemovigilance programme. Haemovigilance means detecting, gathering, and analysing information about adverse and unexpected effects of blood transfusion. Under the haemovigilance programme, DHBs voluntarily report transfusion-related adverse events to the Blood Service.

3.29
The Blood Service's transfusion medicine specialists analyse and summarise adverse events related to transfusion and publish the findings each year in a haemovigilance report. This is in line with international best practice and is a valuable way for the Blood Service and DHBs to promote awareness of risks and best practice and safety in blood transfusion. It helps the Blood Service to identify ways to improve its internal systems and monitor the effects of using different blood products.

3.30
There are few transfusion-related adverse events. In 2011, there were only three life-threatening transfusion-related adverse events reported to the national haemovigilance programme and no transfusion-related deaths recorded.

Systems and processes for district health boards

3.31
The Blood Service has appropriate systems and processes in place to help DHBs to provide suitable transfusion services, including:

  • a 24-hour transfusion medicine clinical advice service for DHB staff and blood banks;
  • yearly oversight review visits of DHB-run blood banks to help them meet and maintain all the requirements to get IANZ accreditation; and
  • working with Hospital Transfusion Committees to improve prescribing and how blood products are used.

Communicating with district health boards

3.32
The Blood Service uses a single main contact – a lead DHB chief executive – to plan and communicate with all DHBs. In our view, this is an efficient way to collaborate and helps the Blood Service to work consistently with DHBs.

7: The policy has been aligned to Risk Management Standard AS/NZS ISO 31000:2009 Risk management – Principles and guidelines and AS/NZS Handbook HB266:2010 – Guide for managing risk in not-for-profit organisations.

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