Qualifications, skills and competencies of Clinical Governance Officer
7. For the purposes of section 24(3)(b) of the Act, an individual is suitably qualified to be appointed a Clinical Governance Officer for a human tissue banking service if the individual —
(a)
is registered under section 20(1) or (2) of the Medical Registration Act 1997 as a fully registered medical practitioner;
(b)
holds a valid practising certificate under the Medical Registration Act 1997;
(c)
is registered under section 22 of the Medical Registration Act 1997 as a specialist in any branch of medicine; and
(d)
has at least 5 years of work experience in providing a human tissue banking service, blood banking or cord blood banking service.
Appointment of advising specialist
8. Where —
(a)
a licensee is approved to provide a specified service; and
(b)
the Clinical Governance Officer appointed by the licensee is not, or none of the Clinical Governance Officers appointed by the licensee is, registered under section 22 of the Medical Registration Act 1997 as a specialist in the branch of medicine relevant to the specified service,
the licensee must appoint a medical practitioner who is so registered as a specialist in the branch of medicine relevant to the specified service to advise the licensee’s Clinical Governance Officer or Clinical Governance Officers on the clinical aspects of the specified service.
General requirements relating to personnel
9.—(1) A licensee must ensure all of the following in relation to each personnel:
(a)
each personnel is adequately trained for the work performed by the personnel and attends regular training in accordance with a continuing training programme;
(b)
each personnel is assessed periodically on the personnel’s competencies and work performance;
(c)
each of the following personnel is supervised by an experienced person when performing any task or providing any service in relation to a specified service that the licensee is approved to provide:
(i)
any personnel with less than 2 years of work experience in performing that task or providing that service;
(ii)
any personnel who has not been assessed by an experienced person to be able to perform the task or provide the service competently without supervision.
(2) In this regulation, “experienced person” means —
(a)
a Clinical Governance Officer; or
(b)
another of the licensee’s personnel with at least 5 years of relevant work experience in providing the specified service and who is designated by a Clinical Governance Officer to provide supervision.
Quality management system
10.—(1) A licensee must establish and implement a quality management system in accordance with this regulation for the purposes of quality assessment and assurance of the human tissue banking service, in relation to the following:
(a)
the safety of donors and recipients;
(b)
the safety and quality, and, where applicable, the viability and potency, of human tissue collected, tested, processed, stored and distributed by the licensee;
(c)
the proper collection, testing, processing, storage and distribution of human tissue.
(2) Without limiting paragraph (1), the quality management system mentioned in that paragraph must provide for all of the following:
(a)
investigation of any occurrence or complaint that discloses or may disclose any weakness or inadequacy affecting the quality of the human tissue banking service;
(b)
identification and implementation of appropriate and effective actions to address any weakness or inadequacy mentioned in sub-paragraph (a) and prevent a recurrence;
(c)
measures to ensure that the provision of the human tissue banking service complies with any written law governing the service and licence conditions imposed under section 13(1) of the Act;
(d)
implementation of quality control measures for all human tissue collected, tested, processed, stored and distributed by the licensee, including measures pertaining to the safety and quality, and, where applicable, the viability and potency of the human tissue in relation to —
(i)
where the licensee recruits donors — the recruitment of donors;
(ii)
the collection and transport of the human tissue;
(iii)
the processing (including testing and quarantine) of the human tissue; and
(iv)
the preservation, storage and distribution of the human tissue;
(e)
implementation of appropriate and effective measures to ensure the safety or health of donors in relation to the collection of human tissue, including the detection and management of any finding or observation that has or may have an adverse effect on the safety or health of the donors;
(f)
maintenance of adequate and appropriate documentation on the clinical outcomes of the transplant or other clinical use of all human tissue distributed by the licensee, including documentation relating to any event, finding or observation that —
(i)
adversely affects or may adversely affect the safety or health of any recipient; and
(ii)
relates to or is the result of the collection, testing, processing, storage or distribution of human tissue by the licensee;
(g)
quality control measures for tests performed and equipment used in the provision of the human tissue banking service, including acceptance testing, quality control tests and regular monitoring of equipment performance;
(h)
a system to ensure the appropriate and adequate documentation of the licensee’s policies and processes, including —
(i)
creating, reviewing and updating documentation for the licensee’s quality assurance measures and all personnel’s compliance with those measures; and
(ii)
ensuring proper document control of all such documentation;
(i)
implementation of a system for appropriate accountability, roles and responsibilities of and continuing educational programmes for all personnel;
(j)
identification of key performance indicators for assessing performance outcomes of the human tissue banking service, including mechanisms for periodic monitoring and evaluation of these indicators;
(k)
the conduct of regular risk assessments of every activity conducted as part of the provision of the human tissue banking service and, where necessary, the implementation of appropriate measures to mitigate or manage the risks identified in those assessments.
(3) A licensee must —
(a)
review the effectiveness of the quality management system for the human tissue banking service on an annual basis; and
(b)
ensure that the quality management system is updated periodically.
(4) In addition, a licensee must —
(a)
participate in and perform satisfactorily for the relevant external quality assessment programme for every type of test that the licensee conducts on human tissue as part of the human tissue banking service; and
(b)
ensure that a Clinical Governance Officer or any other suitably qualified personnel designated by a Clinical Governance Officer reviews the results of the quality assessment programmes mentioned in sub‑paragraph (a) and implements appropriate and effective actions to address any weakness or inadequacy in the provision of the human tissue banking service.
