HFEA-Code of Practice

Covers use and storage of sperm, eggs and embryos for human application as well as research.
Useful reference.

1.-Person Responsible:

- Diploma medical or biological sciences and >2 years of practical experience.
- When PR is unable to carry out their duties must inform the Authority.
- To be PR, individual must complete PR Entry Programme (PREP) assessment.

2.-Staff:

- Documental procedures, annual joint review (improve quality), effective way of
communicating information (receiving suggestions), prepared offer emotional support,
counselling, report promptely all criminal convictions.
- Helthcare scientistsregistrated towards HPC (Health Professions Council).
- Responsible (Andrology or Embryology)Degree+Experience+Registered HPC.

3.-Counselling:

- Not provided any treatment unless proper counselling is done.
- Counselling prior donated gametes/embryos, storage, donation (research, non-medical
fertility services or treatment for others).
- Information given is always confidential.

6.-Legal Parenthood:

- Mothercarrying/carried a child born as result of placing into her an embryo, sperm or
eggs.
- Fathermarriage (unless not consent), consent parenthood or dead (after or before
semen/embryo placed, writing consent and woman <42 days after born).
- Parent of the childcivil partnership (ex. lesbians).
- Surrogacy is permited; mother is who gives birth and intended parents must ask for
parenthood by adoption.
- Sperm and eggs donors not treated as a father or a mother.

7.-Multiple Births:

- Centres must perform a strategy to minimise MB.
- s3 eggs or s2 embryos when own eggs/embryos and <40 years.
- s4 eggs or s3 embryos when own eggs/embryos and >40 years.
- s3 eggs or s2 embryos always when donated eggs/embryos.

8.-Welfare of child:

- No treatment provided unless account of welfare of the child.

9.-PGS:

- Only performed by licensed centres.
- Establish whether embryo has abnormality that may affect capacity of further child.
- Not for sex selection.

10.-Embryo testing and sex selection:

- Only for gender-related disability, ilness or medical condition.
- Not for social reasons.
- PGD for histocompatibility (tissue typing) allowed (must be brother).

11.-Donor recruitment, assesment and screening:

- Screening age, health, medical history, negative for HIV, Hepatitis B, C, Syphilis
- Donors must have <36 years-old for eggs and <41 for sperm.
- Unsuspected heritable conditions must notify Primary Centre+HFEA, pacients born child
and Donor (if required).
- Restriction at 10 children born (donor could ask for sex, number and year of birth).
- Non-identifying information at 16 years-old (physical description, year of birth, ethnic
group)
- Identifying information at 18 years-old (full name, last postal address, date of birth)
- Reasonable payment for donors (35 semen donors and 750 eggs donors). Must be
considered a criminal offence when paying more money.

14.-Surrogacy:

- Permited: child to be treated as the child of the applicants if the child was carried by
another woman, >1 gamete applicant was used, they are married (civil partnership or
living toghether), childs home must be applicants and carrier not payied and freely
understood.

17.-Storage of gametes and embryos:

- s2% cycles use fresh+cryopreserved (eggs or embryos), should inform patients.
- Statutory storage period= 10 years-period of storage (extensions up to 55-years-old). After
Criminal offense.
- 12 months cooling off period since written withdrawal of consent.
- Ovarian and testicular tissue are subjected to the same storage requirements as gametes.

18.-Witnessing and assuring patient and donor identification:

- Cross-check collecting eggs, semen samples, ICSI.all laboratory procedures.

19.-Traceability:

- Identify and locate (gametes, embryos) during any step.

20.-Donor-assisted conception:

- Donor may request information about number, sex and birth year of children born.

21.-ICSI:

- Implications are less number of eggs (immature or embryo damaged) vs IVF.
- Of all ICSI transfers, s2% mixed.
- Not possibility to reinseminate failed to fertilise eggs.

22.-Research:

- Not keep admixed embryos more than 14 days
- Stem cell research permited

23.-Quality Management System:

- Continually improve the Q and effectiveness of service provided.
- QMS=Q manual+SOPs (Standard Operation Protocol)+Guidelines+Training and reference
manuals+Reporting forms.
- Every 12 months (reviews) in order to improve.

26.-Equipment and materials:

- Equipment and technical devices regularly inspected and validated. Also calibrated when
needed.
- Maintenance, cleaning () of all critical equipment performed regularly.
- Reusable instruments validated cleaning and sterilisation procedure has to be in place.
- Only CE marked medical devices must be used (wherever is possible).

27.-Adverse incidents:

- When AI occurred must reprort to HFEA verbal (s12h working) and written (s24h).

30.-Confidentiality and privacy:

- Centre should ensure information provided in confidence is kept confidential and
disclosed only in circumstances permited by law.
- If confidencialy is breached, centre must investigate, deal and submit a fall explanation
to HFEA (criminal offence, must inform police).


WHO 2010



1.-Quality Assurance:

- QC essential to detect and correct systematic errors and highly variability of results.
- Any mesurement has degree of error (magnitude descrived as confidence interval); precise
mesurement limits lie together.
- External QCuseful detecting systematic variation and assessing accuracy.
- Internal QCmesuring variability in procedures within laboratory. Evaluate precission of
day-to-day operations. (Replicate mesurements of sperm concentration, morphology,
motility and vitality).

2.-Reference Values:

- Volume=1,5ml (vs 2ml)
- Sperm Concentration=15 (vs 20)
- Total Sperm number=39
- Progress Motility=32 (vs 25+++ or 50 +++/++)
- Total Motility=40
- Vitality=58% (vs 50%)
- Morphology=4%
- pH=7,2
- Leukocytes <1.10
6
/ml
- MAR Test <50%
- Fructose >13mol/ejaculate

3.-Other:

- Rapid staining procedure for sperm morphology (Diff-Quick)
- Good semen samples used testing containers (during 4hours at 37C)
- Delayed liquefaction or viscosity may use equal Vol of physiological medium or Bromelain.
- Volume is a product of seminal vesicles+prostate gland; |inflamation and +obstruction
ejaculatory duct or bilateral absence vas deferents.
- pH<7,0 (++V ++sperm number) also obstruction or bilateral absence.
- D=V/A where D=depth of chamber and A=area of coverslip. (D=20m)
- Aggregation (debris, immotile) and aglutination (stick together; suggest presence
antisperm antiobodies).
- Motility=PR+NP+IM; counting 200z in, at least, 5 fields.
- Vitality should be performed in all samples but very important when s40% PR; when | IM
alive, suggest structural deffects of the flagellum; and when |IM non-viable, suggest
epididymal patology.
- Cells: testicular damage (immature germ cells), pathology efferent ducts (ciliary tufts) or
inflamatory accesory glands (leukocytes).
C=S(N/400) where S is [Sperm] and N is cell number.
- Morfology: place dragging slide (ange 45), move it into contact with aliquot of semen
(runs along edge slide). Bring dragging slide slowly back along lenght of slide to produce
smear.
- MAR-test: mix semen+red blood cells coated human IgG-A+antihuman IgG or IgA.

EUROPEAN UNION TISSUES AND CELL DIRECTIVES

1.-Definitions:

- Tissue means all constituent parts of the body formed by cells.
- Donor means every human source of human cells or tissues.
- Serious Adverse Event: any adverse occurrence associated with processing of T+C.
- Serious Adverse Reaction: unintended response.

2.-Supervision of human T+C procurement:

- Ensure human T+C are of comparable quality and safety.
- T+C procurement and testing carried out by appropiate person and places.
- All tissue establishments have been accreditated, designated and licensed by competent
authority.
- Appropiate control mesures and inspections (establishments, procedures and examination
of records); not exceed 2 years between them.

3.-Traceability:

- All T+C must be traced from donor to acceptor (viceversa) and products and materials
used.
- Implementation of donor identification system (unique code).
- Data required for traceability shall be kept for at least 30 years after clinical use.

4.-Register of T establishments and reporting obligations:

- Keep a record of their activities (shall submit an annual report).

5.-Quality Management:

- Put in place and update a Q system based on the principles of good practise.
- QS= SOPs+guidelines+training+reference manuals+reporting forms+donor records+
information of final destination of T+CDocumentation available for inspection.

6.-Others:

- Volutary and unpaid donations of T+C (compensation accepted).
- All data rendered anonimous (neither recipients nor donors identificable).
- The identify of recipient not disclosed to donor and his family.
- SOPs include all processes that may affect quality and safety (under control conditions).
- The information must be given by a trained person able to transmit in an appropiate and
clear manner, using terms that are easily understood by the donor (pacient).

COMISSION DIRECTIVE 02/2006

1.-Definitions:

- Quality Systems means organisational structure, defined responsabilities, procedures,
processes and resources for implementing Qualitiy Management and includes all activities
which contribute to quality.
- Standard Operating Procedures means written instructions descriving the steps in a specific
process, including materials and methods to be used and the expected end product.

2.-Select criteria for Tissues and Cells Donors:

- Donors selected on basis at age, health and medical history (questionnaire and personal
interivew).
- Must be negative for HIV, HVB, HVC and Syphilis. Semen donors also Chlamydia. Additional
testing depending on donors history (malaria).
- Genetic screening for autosomal recessive genes if prevalent due to ethnics background.
- Sperm donations (no partners) must quarantined >180 days (repeat testing is required).
- Blood sample required at the time of donation.



COMISSION DIRECTIVE 10/2006


1.-Notification of serious adverse reactions and events:

- Need to have procedures to notify the competent authority all relevant available
information about SAR/E. Also the conclusion of the investigation.
- Embryo misidentification or mix-up shall be considered SAE.


IRISH LEGISLATION


AHR services are carried out in Ireland in the absence of any legislative provisions, and with only
very general guidance from the Irish Medical Council. The Minister for Health set up the
Commission on Assisted Human Reproduction (CAHR) in 2000, and a report from that
Commission was published in 2005.

1.-The Guide to Professional Conduct and Ethics for registred medical practitioners: (2009)
- IVF used after torough investigation shown no other treatment is no effective.
- Appropiate counselling and informed consent given before any treatment
- AR services provided by suitable professionals in appropiate facilities (regular clinic audit)
- Donor programes accepted (altruistic and non-commercial)
- No creation for experimental purposes (human reporductive cloning prohibited)

2.-Report The Comission on Assisted Human Reproduction: (2005)