Tissues and cells legislation

As a long-time quality manager in the fertility industry (European Sperm Bank), I have represented an uncompromising approach to quality, safety and compliance with internal and regulatory requirements (incl. the UK and Germany). My primary task has been to develop, implement and continuously improve a comprehensive quality system – incl. to document all processes, train employees, audit depts., manage serious incidents, host government inspections, monitor legal requirements etc.

In addition – managing the tasks of the Responsible Person (Danish Tissue Order §4/5), it has been my job to ensure that all licensed activities were conducted with proper regard for the regulatory framework. This covers 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.

LHR Consult thus offers to provide help to meet and maintain relevant regulatory requirements and standards, when managing human tissues and cells – as well as assisted reproductive technologies.

Services may include the following:

  • Providing advice and consultation on activities such as  procurement, testing, processing, preservation, storage, coding, distribution, import and export of human tissues and cells.
  • Acting as Responsible Person.
  • Establishing quality goals.
  • Preparation and continuous improvement of quality documents (e.g. policies, standard procedures and work instructions) and -systems.
  • Preparation of other documentation, e.g. third party agreements, consent forms, terms & conditions.
  • Evaluation and optimazation of existing processes/systems.
  • Training of employees.
  • Preparation, execution/hosting of- and follow up on audits and government inspections.
  • Registration, assessment and reporting of unintended incidents (incl. medical devices), deviations, complaints etc. – incl. root cause analysis and corrective/preventive actions (CAPAs).
  • Preparation of risk assessments.
  • Qualification (IQ/OQ/PQ), monitoring and maintenance of laboratory-/cryologistic equipment and processes.
  • Assessment of laboratory kits, diagnostic window periods, test results etc.
  • Preparation of safety procedures (e.g. liquid nitrogen, blood sampling, biohazardous waste, general hygiene).
  • Monitoring of legal requirements, guidelines etc. (e.g. lovtidende.dk, EUR-Lex, STPS, ECDC, HFEA, DIMDI, CDC, WHO, GxP).
  • Liaising with regulatory authorities (e.g. related to registrations, applications, reporting and hearings).
  • Start up of new tissue center, donation site etc.
  • Providing advice and consultation on activities such as genetic counselling/matching, storage, known donor, exclusive donor,  donor-donor child contact and communication, home insemination, sperm analysis etc.).

Services related to the processing of personal data and quality management may well be combined with those mentioned above. For more information – see relevant sub-menus under “Services”.

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