As a long-time quality manager in the fertility industry, I was responsible for ensuring that company activities, products, services and other assets (e.g. sensitive information) met the necessary set of standards based on regulatory/company requirements and customer expectations (DK, UK and DE).
My primary task was to develop, implement and maintain a comprehensive quality management system/information security management system (modelled on ISO 900X/2700X), identify risks and apply relevant controls, document all policies/processes, train and audit employees, manage complaints and incidents, monitoring of compliance etc.
In addition – managing the tasks of the Responsible Person (Danish Tissue Order §4/5), I had to ensure that all licensed activities were conducted with proper regard for the regulatory framework. This covered traceability, consents and contracting, tissue establishment permits, employee qualifications and training, record keeping, reporting and submissions, quality assurance, as well as processes such as procurement, testing, processing, storage, distribution, export and import etc.
Based on this, LHR Consult offers the following services to help meet and maintain the necessary requirements, when managing human tissues/cells and gamete donors – and applying assisted reproductive technologies (ART):
- Providing legal advice on the procedures of sample collection/procurement, acceptance, analysis, processing, coding, preservation, storage, release, sale, distribution/export, import, assisted reproduction technologies, scientific research, recall etc. (DPSA, SSI, Scientific Ethics Commitees, HFEA, BfG, ECDC, EU/GxP, OECD, WHO etc.).
- Acting as Responsible Person (Tissue Order §4/5).
- Mapping of data/dataflows, systems, processes, risks, quality controls and indicators etc.
- Risk management – assessment, analysis, minimization etc. (EU/GxP, ICH, ISO 27005/31000).
- Preparation and management of quality documents/systems – e.g. quality manual, policies, SOPs etc. (EU/GxP, ICH, ISO 2700X/900X etc.).
- Evaluation and optimazation of existing processes/systems (e.g. digitisation/automation of processes and integration of quality controls).
- Providing advice and consultation on donor enrolment, identification, interview, screening, qualification/disqualification, compensation etc.
- Education and continuous training of employees and other stakeholders.
- Preparation, execution/hosting of- and follow up on internal/external audits and government inspections.
- Registration, assessment and reporting of incidents, deviations, complaints etc. – incl. root cause analysis, corrective/preventive actions (CAPAs), trend analyses etc.
- Contract management – preparation, conclusion and maintenance of third party agreements (general practitioners, test laboratories and other service providers).
- Qualification, monitoring and maintenance of laboratory/cryogenic equipment (EU/GxP, OECD, WHO).
- Advice and consultation on blood, urine and semen sampling, analyses, screening (infectious- and genetic carrier diseases, blood chemistry, morphology etc.), laboratory kits, test methods, diagnostic window periods, test results, accreditations etc.
- Monitoring of threats from infectious diseases (e.g. SSI, ECDC, WHO).
- Advice and consultation on relevant safety procedures (liquid nitrogen, blood sampling, biohazardous waste etc.), requirements regarding cleaning, hygiene and sanitation etc.
- Liaising and sparring with fertility clinics, sperm banks, service providers and other stakeholders (product quality/safety, equipment and articles used, processing of incidents, accreditations and legal issues).
- Liaising with regulatory authorities (e.g. registrations, applications, reporting, hearings, notifiable diseases, scientific research and interpretation of legal requirements).
- Start up of new tissue centers, donation sites etc.
- Providing advice and consultation on products and services such as genetic counselling/matching, known/exclusive donor, donor child requests and verification, donor-donor child contact and communication, home insemination etc.
Services related to data protection and quality management may well be combined with those mentioned above. For more information – see relevant sub-menus under “Services”.