Document Number: OMD-E-006-2
Authorised: Beryl Armstrong, Programmes Director, Africa Society for Blood Transfusion
AFRICA SOCIETY
FOR BLOOD TRANSFUSION /
ASSESSMENT OF PREPAREDNESS FOR ACCREDITATION
STEP-WISE ACCREDITATION PROGRAMME
[Name of Blood Transfusion Service]
[Name and email address of contact person]
Introduction
This assessment tool has been designed to assist the management of the Blood Transfusion Service in assessing their preparedness for certification or accreditation in terms of the Africa Society for Blood Transfusion’s Step-Wise Accreditation Programme, and to assist in determining the Step at which to seek such certification or accreditation.
The content in theAssessment of Preparedness for Accreditation(Content), with the exception of Section 1, which is licensed from AABB, is copyrighted by the Africa Society for Blood Transfusion (AfSBT), and remains the intellectual property of AfSBT. All rights reserved. AfSBT and AABB specifically disclaim any and all legal responsibility for Content used by any third party. In no event shall AfSBT or AABB be liable for damages or claims arising from use of the Content.
For the sake of convenience in recording assessment findings, theAssessment of Preparedness for Accreditationis made available in an editable format. AfSBT and AABB specifically disclaim any and all legal responsibility for any changes that may be made to the Content by any third party.
In the following tables, the requirements for certification at Step 1 are shown in black, those for Step 2 in red and the requirements for accreditation at Step 3 in blue.
Important Note – Conducting an assessment is an exercise that requires trained and competent assessors who have a very good understanding of the meaning and the intent of each of the Standards, and of the evidence of compliance that is required during a formal accreditation assessment. Inadequate understanding of the Standards may lead to a completely erroneous evaluation of the state of preparedness of the facility, resulting in a misuse of valuable resources and a sense of frustration on the part of the facility which received the inaccurate assessment. Assessments may be conducted by facility staff (a self-assessment or first party assessment) or by a competent organization contracted to perform the task on the facility’s behalf (a third party assessment).
Facilities contemplating certification or accreditation by AfSBT are strongly encouraged to submit the completed “Assessment of Preparedness for Accreditation (OMD-E-006)” electronically to the Management Office of AfSBT for evaluation as soon as possible following the assessment. This will enable AfSBT to provide assistance and advice on preparing for the formal assessment.
Guidance for performing an assessment
· Review the AfSBT Step-Wise Accreditation Standards (OMD-E-001), the AfSBT Standards Guidance Document (OMD-E-002), and the AfSBT Chart of Evidence of Compliance for Standards (OMD-E-003). Make sure that you understand the intent of each standard, and the evidence of compliance that will be expected during a formal assessment. The AfSBT assessors recognise that there may be more than one way to meet the requirements of each standard, and that it is meeting the intent of the standard that is important.
· Evaluate the current practices at your Service and determine the level of compliance with each standard. It is important to record compliance in terms of current practices and not to record responses in terms of “future plans”. If a document is required in terms of a standard and if this document is not currently available, answer “No”, even if you plan to write such a document in the near future.
· Document your response to each of the standards in the right-most column of the assessment table. If your Service complies with the standard, record the policy or procedure number (if applicable), or a give a brief explanation of how the standard is met.
· If your Service is not in compliance with a standard relating to the Step at which you would like to seek certification/accreditation, record the changes that need to be made in order to achieve compliance with that particular standard. If it is felt that it is not necessary for your Service to comply with a Standard that does not affect quality and /or safety, you may apply for a variance using form FRM-E-009 clearly stating the reasons for the request, and any supporting data that may be available. This application will be considered by the AfSBT Standards Committee and the variance permitted at their discretion.
STANDARDSection 1: Quality System / Compliance Requirement
Step 1 – Black / Step 2- Red / Step 3 - Blue / Record Evidence of Compliance in this Column /
1.1 ORGANIZATION AND STRUCTURE
The blood service or facility shall have a structure that clearly defines the parties responsible for the activities covered by these Standards. This organizational structure shall be captured in writing or electronically.1.1.1 ORGANIZATION
Responsibility for the activities detailed in these Standards shall be assigned to individuals and these individuals may be responsible for more than one activity. Some activities may be delegated to another entity provided the terms of delegated authority and responsibility are clearly defined. / 1.1.1 Organogram exists. /
Reference number of Organogram:
1.1.1 Delegation authority is defined as well as those that may be designees. /Yes / No
1.1.1.1 There shall be an organogram that shows a clear delineation of responsibilities, accountability and inter-relationships / 1.1.1.1 Organogram shows clear delineation of responsibilities, accountability and interrelationships. /Yes / No
1.1.1.2 The organogram shall be reviewed at facility defined intervals and updated as required. / 1.1.1.2 Organogram is reviewed at defined intervals. /State the interval:
1.1.1.2 Organogram is updated as required. /Yes / No
1.1.2 Top ManagementThe facility shall be under the direction of a designated person(s) qualified by training and/or experience who shall be responsible and accountable for ensuring that all operations are carried out properly and competently as required by the relevant laws, regulations and standards.
. / 1.1.2 Top management is defined. /
Reference number of document:
1.1.2 Top management is defined and qualified by training and/or experience. / Job Descriptions / Qualifications / CVs are available.Yes / No
1.1.2.1 Top management shall be responsible for the quality policy and shall provide support to the development, implementation and maintenance of the quality system. / 1.1.2.1 Defined and documented support from top management to the development, implementation and maintenance of the quality system. /Reference number of document:
1.1.3 Medical DirectorThe facility shall The facility shall have a medical director qualified by education, training and/or experience in a scientific or medical field. The medical director shall have responsibility and authority for all medical matters and for the consultative and support services that relate to the care and safety of donors and/or patients. The medical director may delegate these responsibilities to another qualified individual; however, the medical director shall retain ultimate responsibility for the delegated duties. / 1.1.3 Medical Director is qualified. / Job Description / Qualifications / CV are available.
Yes / No
1.1.3 Delegation of Medical Director duties is defined. / Reference number of document:
1.1.3.1 Exceptions to procedures warranted by clinical situations shall require justification and pre-approval by the medical director on a case-by-case basis. / 1.1.3.1 There is documentation of all exceptions to procedures warranted by clinical situations and their pre-approval by the transfusion director. / Reference number of document:
1.1.4 Quality Manager
A designated individual, with training and experience in quality management, shall be appointed with overall responsibility for quality within the facility. This individual shall be responsible for the implementation and maintenance of the quality system. This individual shall report directly to the top management, or to another designated individual who has no direct managerial or supervisory role in collection, processing, testing or distribution of blood. / 1.1.4 An individual (or individuals) who have as part of their assigned duties, the function of carrying out quality tasks. / Job Descriptions / Qualifications / CVs are available.
Yes / No
1.1.4 A quality manager is appointed. / Job Descriptions / Qualifications / CVs are available.Yes / No
1.1.4 There is a quality manager with defined responsibility for quality within the facility.The quality manager reports to the top management. / Job Descriptions / Qualifications / CVs are available.
Yes / No
1.2 QUALITY SYSTEMThe facility shall develop, implement and maintain a quality system, including a quality policy, to address the requirements of section 1 of these Standards. / 1.2 Defined elements of a quality plan are in place. / Document Reference number of Quality Policy:
1.2 Quality policy is implemented. / Yes / No
1.2 The facility develops and implements and maintains a quality system. / Yes / No
1.2.1 The quality system shall be communicated within the facility so that all personnel understand their role in ensuring quality. / 1.2.1 Key personnel are provided with information on quality in the facility. / Yes / No
1.2.1 There is evidence that all personnel understand their role in ensuring quality. / Reference number of document where this is recorded:
1.2.2 Top management shall review and evaluate the quality system at planned intervals and take action to ensure its continuing suitability, adequacy and effectiveness. / 1.2.2 There is evidence that top management has reviewed the quality policy. / Reference number of document where this is recorded:
1.2.2 There is evidence that top management has reviewed the quality policy and system and that there are documented actions to ensure continuing suitability, / Reference number of document where this is recorded:
1.2.3 The facility shall maintain a quality manual that explains how the elements of the quality system apply or have been implemented in the facility. The elements that shall be included are:
1.2.3.1 Organization and Structure
1.2.3.2 The Quality System
1.2.3.3 Resources
1.2.3.4 Documents and Records
1.2.3.5 Suppliers and Service Providers
1.2.3.6 Incoming Receipt, Inspection and Testing
1.2.3.7 Equipment
1.2.3.8 Work Environment and Safety
1.2.3.9 Internal and External Audits
1.2.3.10 Non-conformances
1.2.3.11 Continual Improvement
1.2.3.12 Process Control / 1.2.3 The facility has a quality manual that addresses all elements of these Standards. / Document Reference number of Quality Manual:
1.2.4 Quality system standards shall apply to all activities performed. / 1.2.4 Quality system standards apply to all activities performed. / Document Reference number of Quality Manual:
1.3 RESOURCES
There shall be adequate financial and human resources allocated to meet the requirements of these Standards.
1.3.1 Financial Resources
The facility shall identify financial resource requirements adequate to perform, verify and manage its activities. / 1.3.1 Budget exists. / Yes / No
1.3.1.1 The facility shall develop a budget to ensure its ongoing operation. / 1.3.1.1 There is evidence that financial resources are adequate to perform, verify and manage the activities performed in the facility (via audits or financial assessments). / Yes / No
1.3.2 Human Resources
The facility shall have sufficient, trained personnel, working under supervision, to perform its activities. Personnel performing specific assigned tasks shall be qualified on the basis of education, training and/or experience. / 1.3.2 Personnel are qualified on the basis of education, training and/or experience, and work under supervision until they are qualified to work independently. / Job Descriptions / Qualifications / CVs available for all staff.
Yes / No
1.3.2 There is evidence that the facility has sufficient numbers of qualified and trained personnel. / Organograms available for each work area.
Yes / No
1.3.3 Job Descriptions
The facility shall retain job descriptions, which are required for all personnel, and outline key responsibilities and duties to be performed. Personnel shall have access to their job descriptions. / 1.3.3 Jobs are defined / Yes / No
1.3.3 Jobs are defined and documented.
Job descriptions are accessible to personnel. / Yes / No
1.3.3.1 Job descriptions shall be reviewed at facility defined intervals and updated as required. / 1.3.3.1 There is evidence that job descriptions are reviewed and updated as required. / Yes / No
1.3.3.2 Job title and reporting structure as detailed in each individual’s job description shall correlate with the pertinent information in the facility’s organogram(s). / 1.3.3.2 Jobs are documented to correctly correlate with information in the facility’s organogram. / Yes / No
1.3.4 Training and Competence
There shall be a training policy and programme to ensure all personnel are trained and competent to perform their assigned activities. / 1.3.4 Evidence of employee training exists / Yes / No
1.3.4 There is a training policy. / Reference number of training policy:
1.3.4 There is a defined and documented training programme for all key personnel. / Reference number of document where this is recorded:
1.3.4.1 There shall be a system for competence assessment of individual personnel at facility defined intervals. / 1.3.4.1 There is evidence that competency assessment of personnel is performed. / Reference number of document where this is recorded:
1.3.4.1 There is a defined and documented competency programme for all key personnel. / Reference number of document where this is recorded:
1.4 DOCUMENTS AND RECORDS
The facility shall develop, implement and maintain a document control system that addresses document creation, identification, review, approval, revision, and retention. The document control system shall define procedures for making changes to documents./
1.4 The facility has a defined document control system that includes document creation, identification, review, approval, revision and retention.
/ Reference Number of document:1.4 Documents are removed from use when obsolete or invalid and archived according to a defined documented retention policy. There is a defined procedure which is used to make changes to documents. / Reference Number of document:
1.4.1 Documents shall be:
1.4.1.1 Uniquely identified. / 1.4.1.1 Documents are uniquely identified / Yes / No
1.4.1.2 In a standardized format (additional procedures may be referenced, e.g., manufacturer’s instructions). / 1.4.1.2 Documents are in a standardized format. / Yes / No
1.4.1.3 Current and dated to prevent the use of invalid or obsolete documents. / 1.4.1.3 Documents are current and updated. / Yes / No
1.4.1.4 Reviewed and approved by authorized personnel prior to use. / 1.4.1.4 Operational documents are in writing and approved by authorized personnel prior to use. / Yes / No