Evaluating Standards and Policies Used In Assuring Quality

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In the context of this report, standards are documents produced by a 'standards organisation', which is 'any entity whose primary activities are developing, coordinating, revising and amending, standards that address the interests of a wide base of users outside the standards development organisation'. They can guide and support the processes of clinical and service change. Standards are in essence and essential part of every-day life, without them we would encounter many practical problems in performing routine tasks. We are usually unaware of the role played by standards in ensuring quality, safety, reliability, efficiency and interchangeability but when there is an absence of standards, problems become immediately apparent. For example, purchasers or users of a product will soon notice if it is of poor quality, incompatible with equipment, unreliable or dangerous, all at an economical cost. The adoption of standards of production and testing provides economies of scale in terms of raw material required and the use of standard documentation will lead to a reduction in overheads in terms of training and of linking to legal or regulatory standards.

2.0 Introduction

Before1993 there were 14 Blood centres in England which all collected, tested, processed and distributed blood products. Each centre was autonomous which meant that they each produced specific blood products tailored to the individual requirements of its own local hospitals. In times of shortage customer needs often could not be met because not only were the products of a slightly different specification, but they were produced using different types of machines and methods, there was no uniform barcode labelling, and most of all there was no defined mechanism to transfer between centres. In 1993 the blood service became a truly National Blood Service whereby National policies procedures and specifications were developed to provide a uniformity of approach for all centres.

In October 2005, following a consolidation of numerous NHS department and functions under the umbrella of the Arms length Bodies Review of 2003, the service became established as a Special Health Authority and was re-named The National Health Service - Blood and Transplant (NHSBT) [1] . It had been identified that there were clear opportunities to remove duplication of numerous activities by merging UK Transplant with the National Blood Service and thus reduce costs to the NHS. The newly established NHSBT had three key disciplines:-

The National Blood Service - Collection, Testing, Processing and Issue of blood products.

Organ Donation and Transplantation - Collection, Testing, Processing and Distribution of organs for transplantation, and other Tissue Services.

Bio Products Laboratory - Established as a Pharmaceutical wing of the organisation to fractionate plasma into its component therapeutic parts to supply the NHS and any other heath organisation.

The NHSBT is accountable to the Department of Health for the standard of products and services provided. It is also subject to the Healthcare Commission's 'Annual Health Check' against the Department of Health's 'Standards for Better Health' - the national process by which performance is measures and assessed. HPA core Standards Declaration 2008/2009 [2] 

The NHSBT is subject to regulation by the Medicines and Healthcare Regulatory Authority (MHRA) through the Blood Safety and Quality Regulations 2005 (SI 2005 No. 50) [3] and through various other guidelines including Guidelines for the Blood Transfusion Services in the United Kingdom [4] , the "Rules and Guidance for Pharmaceutical Manufacturers and Distributors [5] and Code of Practice for Tissue Banks [6] which governs the provision of tissues of human origin for therapeutic purposes. These regulations set standards for quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and apply to 'blood establishments' in the UK Blood Services and Hospital Blood Banks.

Within the NHSBT there are also several departments that fall under the description of Specialist Services and each of these disciplines has its own regulatory and accreditation body. Examples of some of these specialist Services would be, the Stem Cell department which deals with new technologies to harvest and store progenitor cells to assist in the treatment of blood related cancer, the Red Cell Investigation department which investigates compatibility issues with blood transfusions, and the Histocompatibility & Immunogenetics department who work to ensure compatibility between recipient and donor organs.

How Standards and Policies Add Value to the Service

The Range of Standards

When the agreed guidelines and legislations were introduced, it facilitated the move to standardise products and practices between the centres. A National Management was created which consisted of a Chairman, Executive Board of directors and Chief Executive answerable to the government. With the implementation of this national management structure, decisions were made and enforced across the 14 centres, this would ensure that at all times the same level of service would be provided, and identical products available all over the country. For the hospitals it would mean that they could be assured that the product would be of the same specification and level of quality, with the same labelling and bar-coded information, wherever the unit of blood came from.

3.2 Product Standardisation

Under EU regulations the Blood donor is the raw material in the process. The standard of the blood can vary enormously depending on the lifestyle and age of the 'raw material' unlike raw material for a pharmaceutical product. The regulations are similar to ISO 9001:2008 [7] in that:-

"The organisation shall preserve the conformity of the product during internal processing and delivery to the intended destination. This preservation shall include identification, handling, packaging, storage and protection. Preservation shall also apply to the constituent part of the product."

The impetus for standardisation was the EU directive 85/374/EEC [8] which binds member states to product liability. Human blood, and components derived from it, is defined as 'products' in terms of the directive, and guidelines against which manufacturers could be inspected were now needed. Standardisation relied firstly upon agreement on what blood products are provided and with this the 'Red Book', (Guidelines for the Blood Transfusions Services in the United Kingdom) was compiled and published. These guidelines are compiled by the Standing Advisory Committee which consists of people from a wide range of different disciplines both within and outside of the Blood Service, and covers all blood services throughout the UK. It is administered by JPAC, the Joint UKBTS/NIBSV Professional Advisory Committee.

All aspects of the Quality System, from donor selection through to the issue of products to the hospital, are covered by standards which have quality built into the whole process and therefore don't rely on quality control at the end of the process. Working with the regulatory bodies and experts within the service to create the guidelines has benefits to the NHSBT. 'Companies can influence the shape of legislation, if they act soon enough, the better informed officials are in the early stages of negotiations, the more effective their influence will be on the direction in which the legislation takes'. [9] 

The NHSBT has a Quality system based on ISO9000 standards. The standards are controlled by both regulations and legislations. The legislation is set as European Standard Directive 2002/98/EC [10] . There are three sub directives to cover technical requirement for standards for blood and blood components (2005/33/EC) 10, Quality Systems (2005/61/EC) 10 and Traceability (2005/61/EC).10. The Blood Safety and Quality Regulations 2005 transpose these directives into UK law whilst the European (EN) Standards contain the detail and define precisely what must be done to comply with the legislation. .

Because of its monopoly on supply the NHSBT main focus is not towards maintaining the market share but works towards compliance with regulation and legislation. Likewise the NHSBT does not work towards gaining accreditation to standards for sustainability and Health & Safety. The organisation is however, audited by ROSPA against BS18001 and has stated that the organisation meets the required standards but is not accredited against the standard.

Whilst professional guidelines are not legally binding they do reflect 'best practice' and may be taken into consideration by the UK judiciary. When the EU directives are formulated, national guidelines are taken into account and then the EU directives are written into UK law,

3.3 Standardisation of Communication - Products and Software

In order to 'trade' from one centre to another the initial focus was to ensure that a standard labelling format was used. In this case, ISBT 128 [11] with standard symbology. [12] 

The installation of a national IT system, PULSE, allowed the transfer of products from one centre to another and the standard for reading the data communicated to NHS hospitals. In addition to product data the NHSBT also defined a product portfolio [13] to inform customers of each product available and specification, linked to the 'Red Book' reference guidelines.

The single computer system, PULSE, was designed to cover the core service of collection, processing, testing and issue of products to customer hospital. Controls to safeguard the product standards was incorporated into the computer system to ensure that only products fit for purpose and meeting all the criteria were released. The system would not allow for example underweight, untested or incorrect blood grouped products to be released for issue. A separate national computer system had to be designed and installed to cover patient related diagnostic services as their guidelines governing these activities are different.

3.4 Standardisation of Measuring and Calibration

The 'Red Book' defines the criteria for acceptance of a blood donation. How this is achieved and measured is outlined in the Rules and Guidance for Pharmaceutical Manufacturers and Distributor (known as the 'Orange Guide') which states that equipment that is critical for assuring the quality of a product must be calibrated in accordance with written procedures and an established schedule. Calibration should be performed using standards that are traceable to certified UKAS standards. Auditing of the manufacture of blood and blood products is usually done against the BSQR, the 'Red Book' and the 'Orange Guide'.

3.5 Standardisation of Documentation

NHSBT follows a similar regulatory route as the Food and Drug Administration (FDA) [14] and ISO9001:2000, in that National Standard Operating Procedures (SOPs) have been put in place to ensure that the same process is followed irrespective of who is performing the procedure. These are controlled similar to ISO9001:2000 [15] to make sure that the only the most current document is in use and obsolete version is withdrawn. Each procedure has to be process mapped and then generic SOPs written to ensure standardisation. The use of local documents had ceased as these allowed variations and local interpretation which may not have been linked to national standards.

Unlike ISO the NHSBT do not have a single Organisational Quality Manual although many aspects, such as product recall and traceability, are addressed.

3.6 Standardisation of Suppliers and Access to External Engineers

Facilities management are responsible for the building, its maintenance, security and they control access. Suppliers are audited and engineers vetted before being allowed to work on site. Building management is regulated in the Orange Guide and the Red Book.

There are also standards for the removal clinical waste. [16] It is segregated by colour coding and clear labelling to comply with safe management of healthcare waste, also covered by SI 1993 No 566 The Controlled Waste (amendment) Regulations 1993.

Under WEEE regulations [17] any electrical equipment has to be disposed of by a licensed carrier.

3.7 Standardisation of Equipment, Consumables and Testing

A reduction in the range of products available and the subsequent reduction in product variety that was agreed by all centres has benefitted the organisation in terms of raw materials required. With regard to consumables and diagnostic kits there is considerable effort involved in the specification, evaluation and validation of test kits before they are accepted onto an approved list. A national procurement department defines standards for providers to tender business. Similarly, equipment and computer systems are validated before installation and a full change control programme is followed to ensure that they will perform as expected and any errors noted and rectified before products are released onto the market.

The effect of regulatory standards on stakeholders is beneficial in that customers, ie Hospital Blood Banks, and Consultants Haematologists, together with the Department of Health and European Directive drive the service to meet customer demands while ensuring that the product meets quality standards

3.8 Standardisation of CA/PA and Event Management

If a Quality Incident occurs, the NHSBT follow a standard approach. Investigation of the incident provides detailed documented corrective action and the implementation of preventive action is monitored to prevent any repetition of the incident. Incidents are categorised as Critical, Major or Other. Any Critical or Major events require a root cause analysis to be performed.

Standardisation of Training and Competency

Structured training programmes are developed and staff are trained to enable them to perform quality tasks They are required to demonstrate competence in the task before they can carry it out. The training increases the skills base within an organisation and gives greater flexibility within the workforce. Continuous development of the staff gives them greater opportunities .for advancement and increases their portfolio.

3.10 How Standards/Policies Contribute to the Quality Process

The culture of the NHSBT is still focused to some extent on local systems. Whilst the national policies and procedures are in place there is still room for local interpretation which is compounded because the centres do not yet have the same equipment, work space etc which influence and encourage deviation. The culture in the service is often a barrier to standardisation as in order to obtain agreement to replace local SOPs with national documents it was necessary to produce generic documents which although linked to standards are still open to interpretation.

3.11 How Standards/Policies Add Value to an organisation

The standards and policies utilised by any organisation including the NHSBT can benefit them in many ways. Management systems standards in particular will streamline processes and make an organisation more efficient. This will often have the effect of reducing operating costs, eg by reducing materials costs and minimising wastage. Standards can also take a lot of the costs out of R&D work because the work will have already been done before the standard was approved. Standards are tried and tested, so adopting a standard reduces errors and the cost of errors and by providing a straight-forward route to compliance with regulatory requirements, particularly on safety, building and environmental regulations, they can also reduce exposure and the cost of compliance. [18] The organisation is then able to satisfy the customer's needs by their ability to produce a quality product in an efficient, timely and economic manner.

4.0 Conclusion

It is clear that a lack of regulation and standardisation can lead to a serious effect on customers.

Standards are designed to achieve the highest possible levels of quality and efficiency but they are only as good as the investment an organisation makes towards staff skills and training, costs, operating systems, relationships with end users. Different people interpret things in different ways even if they are in the same field of work. While standards may be fixed they are in a changeable environment so any standards policy that is implemented interacts with others within an organisation and that needs to be considered when formulating the implementation within an organisation. "... Neither standards nor monitoring of performance are ends in themselves; the key test is whether they are leading to sustained improvements...." [19]