Best practice for embryology staffing in HFEA licensed assisted conception centres-guidance from Association of Reproductive & Clinical Scientists

Figures & data

Figure 1. Career pathway for scientific staff within a HFEA licensed centre. ARCS recommended and recognised job titles, qualifications, registration (where applicable) and suggested NHS salaries. Based on nationally recognised NHS job profiles for Healthcare Scientists.

*Staff at band 6 and below can only work under the direct supervision (i.e. on-site) of a registered Clinical Scientist.

Note- An MSc or MSc level qualification (e.g. ACE certificate or Diploma) in addition to a BSc is the minimum qualification appropriate for a Clinical Embryologist. Those entering the HCPC register by any route (e.g. the Association of Clinical Scientists, AHCS equivalence) have met this standard. Consultant level staff attain specialist Doctoral level qualifications through completion of the higher specialist training programme and/or attainment of Fellowship of the RCPath via completion of part 2 exams or acknowledgement of equivalence through admission to the AHCS higher specialist register. Whilst a PhD in the field can be used to fulfil some requirements for FRCPath attainment and entrance to the higher specialist register, a PhD cannot be used as a proxy for these qualifications or entrance to the HSS register. Likewise, FRCPath attainment alone may not fulfill all the standards for entry to the higher specialist register.

Staff in supporting roles may be used to assist the clinical scientific workforce, but it is important to note that they cannot be used as a replacement. A state registered Clinical Scientist must always be on-site to supervise clinical procedures. See Appendix A for Reproductive Science Assistant, Associate and Practitioner job roles.

Figure 2. Example chart of Routes to HCPC and HSS Registration.

Table A1. Roles for reproductive science practitioners in HFEA-licensed centres*.

Reproductive science practitioner	Reproductive science practitioner
Scope of Practice One (suggested Band 5)	Scope of Practice Two (suggested Band 6)
Quality management: assist with Quality tasks Including	Duties of Scope of Practice One plus:
validation / revalidation of equipment and procedures	Preparation of materials in advance of embryological procedures such as ICSI or cryopreservation
risk assessment	Preparation of workstations for embryological procedures
key performance indicators	Participate in the processes for collection, collation and monitoring of the clinical outcome of treatment cycles
audit of procedures, processes and cryostored material document control Standard Operating Procedures	Participate in the processes for collection, collation, reporting and analysis of Key Performance Indicators
quality control and quality assurance quality improvement
internal and external incident reporting
Maintenance of the laboratory environment
maintenance and monitoring of air quality microbiological monitoring	Handle human gametes for clinical use in treatment or donation under direct supervision of a Clinical Scientist
maintenance, monitoring and traceability of laboratory equipment	Use gamete and embryo handling devices
effective and efficient stock control and traceability	Undertake IVF insemination Remove cumulus cells from oocytes prior to intra-cytoplasmic sperm injection (ICSI) or cryopreservation
Specialized cleaning and decontamination of the laboratory and its equipment	Assess and record the meiotic status of oocytes
Monitor the effectiveness of the cryopreservation facility: assist with	Remove cumulus cells from Day-1 embryos prior to assessment of pronuclear status
Maintenance and monitoring of equipment, storage vessels and Alarms	Assess and record pronuclear status
Maintenance and surveillance of liquid nitrogen storage vessels Preparation, monitoring and use of a dry shipper Documentation of stored material Audit of stored material Communication with patients regarding stored material	Move embryos between different culture vessels Record accurate observations of embryo morphology and developmental status Move gametes and embryos into and out of cryostorage
checking adherence to statutory storage requirements	Release and receive cryopreserved gametes and embryos to/from other licensed centres
Record, report and audit laboratory activities	Cryopreserve and thaw sperm samples from patients and donors,
Check documentation of consent and screening tests
• Act as a witness for laboratory and clinical procedures • Work using sterile technique • Select and prepare materials for cell culture of gametes and embryos	Cryopreserve oocytes (pre-selected by embryologist) by slow freezing and/or vitrification
Assist in the andrology laboratory	Thaw or warm oocytes
• Identify and instruct males providing semen samples • Receive semen samples prior to assessment or processing • Perform semen assessment prior to licensed fertility treatment	Cryopreserve embryos (pre-selected by embryologist) by slow freezing and/or vitrification Thaw or warm embryos
Handle human gametes for clinical use in treatment or donation (under direct supervision of a Clinical Scientist)
• Prepare sperm samples for clinical use • Participate in surgical sperm retrieval procedures •Process and prepare surgically- retrieved sperm •Participate in oocyte collection procedures • Identify oocytes, cumulus cells, granulosa cells and clinical features such as cystic fluids •Process and prepare oocytes for clinical use (NOT including oocyte denudation) including ejaculated and surgically- retrieved sperm samples.

(Note: unlike the training for Clinical Scientists, where competence in all techniques is a requirement of training, trainee Practitioners are required only to gain practical competence in the cryopreservation techniques that will form part of their job at their workplace).

Table A2. Roles for assistants and associates in HFEA-licensed centres.

Assistant – Band 2	Assistant – Band 3	Associate – Band 4
Assist in audits	Duties of Band 2 plus:	Duties of Band 2 and 3 plus:
Prepare the environment for handling specimens	Check appropriate consents are in place and signed	Use standard laboratory equipment
Identify and instruct males providing semen Samples	Check appropriate blood test results are completed and signed Off	Perform semen assessment prior to licensed fertility treatment (NOT prior to use of the sample for treatment, storage or donation)
Book appointments	Record and keep accurate written and computerized records of all procedures
Answer the telephone and relay messages appropriately
Assist with monitoring and maintaining the liquid nitrogen storage facilities
Charge and use a Dry Shipper Assist with cryobank management Act as a witness for procedures Clean surfaces, equipment and laboratory floor Assist with stock control, traceability and ordering of consumables Receive, unpack and appropriately record consumables Assist with quality control assessments and other routine monitoring of critical laboratory equipment undertaken in the laboratory	Use specialized databases for recording and reporting laboratory activities	Use sterile technique for handling solutions and culture media • Prepare culture vessels for use in embryological procedures • Label dishes, vials, straws and canes • Advise on access to and use of service to patients • Assist in preparation of documentation for transport of gametes and embryos between licensed centres

*For the higher banded jobs this is already clearly detailed in other documents such as the HCPC/AHCS/ACS competencies. For higher specialists (Consultants) this is contained in the RCPath higher specialist curriculum.