JPAC Joint United Kingdom (UK) Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee

QMS Specification

OUTLINE SPECIFICATION FOR A QUALITY MANAGEMENT SYSTEM FOR HOSPITAL BLOOD BANKS
   

This outline specification for hospital blood banks has been prepared by the NHS Operational Impact Group (OIG) which represents hospital blood banks and UK Blood Services and was established by the Department of Health to advise on major issues arising from the Blood Safety and Quality Regulations 2005.

It is recommended that this specification be incorporated within a Quality Manual which describes the quality system in the hospital blood bank.

The Blood Safety and Quality Regulations 2005 require hospital blood banks to submit a compliance report to the Competent Authority (MHRA) by 08 November 2005 and annually thereafter. This report needs to confirm whether the blood bank is compliant with the essential requirements of the Regulations and its state of preparedness for a number of other issues. Highlighted text appears within this specification to draw attention to items which MHRA have advised need to be in place by 08 November 2005 (these are shown in bold typeface with grey shading). Those for which the extent of preparedness is to be advised to MHRA are shown in black outline with pale grey shading.

1

PERSONNEL

1.1

There are competent and appropriately qualified personnel, in sufficient number, to ensure an appropriate service is delivered.

1.2

There is an appropriate organisational structure and approved job descriptions.

1.3

There is an individual (the Quality Manager) who has designated responsibility and authority to ensure the effective operation of the Quality Management System.

1.4

Staff are provided with timely, relevant and regularly updated training including an induction programme.

1.5

There are hygiene programmes relating to health and safety; personal hygiene and clothing.

1.6

Regular staff meetings are held to review services.

1.7

There is a staff appraisal system.

2

PREMISES AND EQUIPMENT

2.1

The facility must be provided with premises and equipment that are located, designed, constructed, adapted, validated and maintained to suit the intended operations;

2.2

Lay out, design and operation must be designed to minimise the risk of errors and permit effective cleaning and maintenance;

2.3

There is appropriate office and laboratory space.

2.4

There are adequate, suitably located staff facilities

2.5

Where applicable there are adequate facilities for patients

2.6

There is appropriate space available for specimen reception, handling, despatch and disposal.

2.7

There are appropriate and adequate data storage, retrieval and communication facilities.

2.8

The laboratory equipment meets the demands of the service and is properly validated, maintained and calibrated.

2.9

There is adequate and safe provision of lighting, heating, ventilation, power, gases, water and drainage.

2.10

There are adequate storage facilities for specimens, reagents and records.

2.11

Blood Bank facilities should comply with the current BCSH guidelines and other relevant standards (eg BS 4376). Where relevant, they will also comply with the requirements of Good Manufacturing Practice as laid out in Eudralex Volume 4 contained in the current version of “Rules and Guidance for Pharmaceutical Manufacturers”, the Stationery Office.

2.12

There is a safe working environment in accordance with current legislation.

2.13

There are appropriately sited facilities available to support training and continuing education.

3

DOCUMENTATION

3.1

There is a controlled document system in which written procedures describe the work processes and which are regularly reviewed to keep them error free and up to date. This should include:
  • A summary of the Quality Management System;
  • Records;
  • Worksheets;
  • Labels;
  • SOPs;
  • Incident Management System;
  • Change control system;
  • Personnel documentation; including organisation chart, job descriptions and training records.

3.2

Appropriate records are maintained within Health Boards/ Health Authorities/ Trusts. With regard to records which permit the traceability of blood from donor to patient (or final fate if not transfused) the following data items need to be available and accessible for 30 years:
  • Donation number
  • Component type
  • Blood establishment which provided the blood component
  • Date provided
  • Identity of patient who received the blood component or final fate if not transfused.
Health Boards/ Health Authorities/ Trusts shall determine how this requirement is met eg; by entry into a computer database at ward or in the blood bank or by making a record available which is stored separately from the patients notes, possibly in the blood bank, to facilitate storage for 30 years.

3.3

Compliance with this requirement for traceability will be verified periodically.

3.4

Additionally, it is highly desirable that the record keeping dataset be extended to include information about the transfusion. ie:

 

  • The identity of the person who prescribed the blood component - GMC number (or name);
  • Details of the ‘consent to transfusion’;
  • The reason for the transfusion;
  • The identity of the person who collected the blood (from Blood Bank or Blood Fridge) and the date and time of collection;
  • The identity of the person(s) who undertook the pre-transfusion checks;
  • The date and time of the transfusion;
  • Any adverse events related to the transfusion.

 

This data capture would best be achieved using a computerised system.

3.5

When electronic, photographic or other data processing systems are used instead of typed/ written documents, the system shall have been validated to demonstrate the data will be appropriately stored and can be accessed throughout the period of storage. Electronic data shall be protected against loss or damage of data during storage.

4

PROCEDURES

4.1

Procedures will be carried out according to pre-established and documented instructions in accordance with good practice.

4.2

All test methodology should be validated to demonstrate reliable performance before introduction. Tests must be performed by trained staff, using in-date reagents and appropriate controls. Acceptance criteria should be established for all test methods. If acceptance criteria are not met, then test results should not be reported.

4.3

There is a formal, documented system for change control.

4.4

There is a formal, documented system in which management regularly reviews the performance of the Quality Management System.

4.5

As a minimum, documented procedures should exist for the following key activities:

4.5.1

There is an up to date user manual.

4.5.2

Request forms for laboratory investigations and specimen labels include provision for unique patient identification and adequate supporting information.

4.5.3

Reports of laboratory results are validated prior to despatch, are timely, accurate and comprehensive. They must include unique patient identity, date of testing/reporting and name and location of requesting clinician.

4.5.4

Interpretative reports are unambiguous, comprehensive and clinically relevant.

4.5.5

There are written procedures relating to specimen collection, handling, retention, despatch and disposal. This includes clear instructions on how to deal with incorrectly labelled specimens and/or improperly completed request documents.

4.5.6

If the hospital where the department is sited is a potential receiving centre for a major accident, there is a readily accessible document within the department instructing staff on procedure.

4.5.7

There is a record of all reagents, calibration and quality control material.

4.5.8

There is a standard operating procedure for the performance of each test.

4.5.9

There is a standard operating procedure for oral transmission of results.

4.5.10

There are standard operating procedures for the regular maintenance of equipment.

4.5.11

There is a standard operating policy describing any out of hours service.

4.5.12

In hospitals, a nominated consultant in the microbiology department is responsible for infection control.

4.5.13

There are standard operating procedures for the storage, distribution and transport of blood and blood components within and outwith the Hospital.

4.5.14

There are standard operating procedures for the clinical transfusion process.

4.5.15

There are standard operating procedures to ensure the safety of transfusion in all settings.

4.5.16

There are standard operating procedures covering temperature controlled storage, its monitoring and management of the “cold chain”.

4.5.17

There are standard procedures for the validation and calibration of processes and equipment.

4.5.18

There are standard operating procedures for the notification of serious adverse events and reactions that satisfy the requirements of the Blood Safety and Quality Regulations 2005.

4.5.19

There are standard operating procedures that allow Blood Banks to accurately, efficiently and verifiably withdraw blood and blood components involved in serious adverse events or reactions or that are judged to have the potential to cause harm to patients.

5

SERIOUS ADVERSE EVENT AND REACTION REPORTING

5.1

Serious adverse events and serious adverse reactions must be notified to the competent authority, or an agency approved by the competent authority, in a timely and efficient manner

5.2

There are procedures that allow Blood Banks to accurately, efficiently and verifiably withdraw blood and blood components involved in serious adverse events or reactions or that are otherwise judged to have the potential to cause harm to patients.

6

SELF INSPECTION

6.1

There is an ongoing programme of self inspections (audit) which includes periodic audit of compliance with the “traceability” requirements of the Blood Safety and Quality Regulations 2005.

6.2

There is a programme of external inspection/ accreditation.

6.3

Blood Banks participate in appropriate external proficiency testing schemes.

6.4

Blood Banks must have a formal policy for internal quality control

6.5

Where appropriate, the performance in quality assessment schemes is widely publicised in the department with regular formal review.

6.6

There is a programme of quality assurance evaluation which includes continuing audit of the service provided.