Assisted conception service

Assisted conception service

Assisted Conception Service

The assisted conception service operates within an approved scope of practice as required by the national regulatory authority and is delivered by qualified and competent personnel with due regard to the confidentiality and sensitivity of this treatment. This standard is designed to be used by services who are required to work within European Union Directives 2004/23/EC, 2006/17/EC, and 2006/86/EC. In the absence of national regulatory requirements, the service is provided to an agreed standard, for example the European Society of Human Reproduction and Embryology (ESHRE) or similar. Please note that your service must remain in line with the on-going changes for this healthcare sector as countries review, for example, storage, consent and surrogacy amendments. Furthermore, an award of CHKS accreditation (including ISO 9001:2015 Certification if included in the Contract) does NOT confer regulatory certification for the service nor does it confer either ISO 17025 (Testing and Calibration) or ISO 15189 (Medical Laboratories) status for the service. This standard includes the following:

• Licensing and regulation
• Management and staffing
• Assessment and pre-procedure
• Clinical guidelines
• Confidentiality and information
• Environment
• Laboratory processes
• Traceability
• Laboratory environment
• Quality improvement

The CHKS Standards criteria address these elements through succinct criteria statements that are supported by guidance which helps the organisation understand the intent of the criteria, so that it can be applied in the local context.

Additionally, references are provided to direct further reading on the relevant topic.

Throughout the standards the criteria are linked to key assessment frameworks including ISO 9001, the Care Quality Commission, Quality Statements and the Health Information and Quality Authority, (Ireland) National Standards.