Download HAAD Standard for Assisted Reproductive Technology Services and

Document Title:
HAAD Standard for Assisted Reproductive Technology Services and Treatment
Document Ref. Number:
HAAD/SD/ART/1.1
Version:
1.1
Approval Date:
04/08/2014
Effective Date:
07/08/2014
Last Reviewed:
December 2009 Version 1
Next Review:
August 2016
Revision History:
HAAD Standard for Regulating Artificial Reproductive Technology
(ART) version 1.0, 2007
Health Regulation Division
Document Owner:
Applies to:
Classification:
Healthcare Facilities and Professionals licensed by HAAD in the Emirate of
Abu Dhabi
 Public
1. Purpose
1.1This standard aims to ensure the delivery of quality and safe clinical care for
Assisted Reproductive Technologies (ARTs). It specifies the following requirements:
1.1.1 The circumstances under which patients will be able to access
ART services and treatment;
1.1.2 The Standards for ART services;
1.1.3 Facilities licensing specifications.
2. Scope
2.1 This standard applies to Healthcare Facilities and Professionals licensed by HAAD in
the Emirate of Abu Dhabi allowed under HAAD licence to provide ART services;
2.2 It replaces the HAAD Standard for Regulating Artificial Reproductive Technology
(ART) version 1.0; and
2.3 This Standard must be read in conjunction to the Federal Law number 11 for
Fertilisation (2008), HAAD Standard for Consent, HAAD Standard for Cultural Sensitivity
and Awareness, HAAD Standard for Adverse Events Management and Reporting, the
Standards of Care Policy, Chapter VIII of the HAAD Healthcare Providers Policy Manual,
Version 1.0 and the Licensing Policy and Professional Duties Policy, Chapters III and IV,
respectively, of the HAAD Healthcare Professionals Policy Manual Version 1.0.
3. Definition
3.1. Infertility: This is defined as the inability of a married, sexually active couple to
achieve pregnancy within one year of unprotected regular intercourse. Infertility
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may be diagnosed prior to one year if there are features or findings indicative of
subfertility. These include:
 Oligo or amenorrhoea;
 Inability to have intercourse;
 Previous adjuvant therapy for cancer in either partner
 History indicating an increased risk of Fallopian tube occlusion (i.e. previous
pelvic infection or previous pelvic surgery)
 Advanced female age (>35 years)
 Oligozoospermia or azospermia
3.2. Assisted Reproductive Techniques (ART): ART includes any treatment offered to
couples experiencing reproductive problems, which require handling of their
gametes extra-corporeally. These treatments include, but are not limited to,
intrauterine insemination, in vitro fertilisation, intracytoplasmic sperm injection,
gamete cryopreservation, gamete intra fallopian transfer (GIFT), all techniques of
surgical sperm extraction for the purpose of ART and all techniques of
cytogenetic analysis of gametes or embryos (including oocyte polar body biopsy,
pre-implantation genetic diagnosis and screening).
4. Duties for healthcare Providers/Payers/Third Party Administrators (TPAs)
4.1. All healthcare providers, including healthcare facilities and professionals, licensed
by HAAD to provide ART services must:
4.1.1. Provide clinical services in accordance with the requirements of this
Standard, and the relevant HAAD Clinical Care Standards and ensure that
their practices reflect internationally recognised evidence based clinical care
pathways, delivered in the context of the UAE culture and laws;
4.1.2. Report and submit e-Claims data in accordance with the Data
Management Policy, Chapter VI, Healthcare Regulator Manual Version 1.0
and as set out in the HAAD Data Standards and Procedures
(www.haad.ae/datadictionary);
4.1.3. Document and monitor quality and safety of clinical care and outcomes of
ART treatment performed on patients, and make these available to HAAD for
auditing, as and when requested to do so (Appendix 1);
4.1.4. Comply with HAAD policies and standards on managing patient medical
records. It is mandatory to have in place a system for effective data
recording, maintaining patient records, maintaining confidentiality, adverse
events management and reporting, and protecting the privacy and security
of patient information;
4.1.5. Ensure the well-being of the patient and unborn child is at the forefront of
decisions that lead to treatment and treatment options;
4.1.6. Comply with the requirements of patient education on the treatment and
associated procedures, the risks and benefits, their suitability for ART
intervention and the likelihood of its success and any needs for treatment
and care pre and post interventions. Patient notes must clearly have
documented:
4.1.6.1
Predicted success rates;
4.1.6.2
Risk of cycle cancellation due to no response or over
response to ovarian stimulation;
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4.1.6.3
Risk of multiple pregnancy and the associated morbidity to
the mother and unborn children;
4.1.6.4
Clear documentation of any alternatives offered.
4.1.7 Ensure that patients are provided with a written summary of their
diagnosis and planned treatments prior to the commencement of any
ART procedure;
4.1.8 Comply with the requirements of patient informed consent ensuring
that patients have all the required information for each stage of the
intervention explained and document the patients’ consent in
accordance with the HAAD Policy on Consent, and that patients are
treated in accordance with the obligations under the patients’ rights
and responsibilities charter and the HAAD Policy on Cultural Sensitivity
and Awareness in Healthcare Facilities;
4.1.9 Clinicians must ensure healthy patients/couples remain healthy and
are not exposed to any harm during the treatment process;
4.1.10 Have in place policies and procedures that comply with HAAD
Standards and Federal Law number 11 for Fertilisation (2008); and
4.1.11 Comply with HAAD requests to inspect and audit records and
cooperate with HAAD authorised auditors, as required for inspections
and audits by HAAD;
4.2
All Payers and TPAs must:
4.2.1Comply with the provisions and requirements of this Standard in respect
of healthcare services specified in this Standard to be covered under the
health insurance scheme;
4.2.2Ensure that authorization of these healthcare services for the purposes of
coverage under the patients’ health insurance plan are completed within no
more than 4 weeks.
5. Enforcement and Sanctions
5.1. Healthcare providers, payer and TPAs, must comply with the terms and
requirements of this Standard, the HAAD Standard Provider Contract and the
HAAD Data Standards and Procedures. HAAD may impose sanctions in relation to
any breach of requirements under this standard in accordance with the
Complaints, Investigations, Regulatory Action and Sanctions Policy, Chapter IX,
Healthcare Regulator Policy Manual Version 1.0.
6. Standard 1 – Service Specifications
6.1. The Healthcare Provider must comply with the following requirements:
6.1.1Only HAAD licensed facilities (Fertilisation Centre) are eligible to
provide ART treatment. A HAAD license is mandatory for all centres that
provide ART as a purposefully licensed facility (i.e. for ART services only) and
all other facilities in Abu Dhabi which satellite patients into this purposefully
licensed facility (including centres which satellite patients from outside the
Emirate of Abu Dhabi for procedures taking place in a primary centre
located in Abu Dhabi);
6.2. Ensure that the multi-disciplinary teams comprise of all HAAD licensed personnel
necessary to deliver services in accordance with this Standard, and that IVF
Providers and Professionals comply with the requirements of Federal Law number
11 for Fertilisation (2008);
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6.2.1Have in place a nominated Director for ART services;
6.2.2 Have all the necessary equipment and supplies to undertake ART
interventions and procedures in a safe and effective manner in order to
maximise patient outcomes and provide a high quality service;
6.2.3Ensure that adequate levels of supplies are available to serve the
population of patients treated and that equipment are routinely maintained
and serviced in accordance with the manufacturer’s recommendations, and
retain records to evidence this;
6.2.4 Have a formal process for patient assessment, education, counselling,
risk management, treatment and follow up of outcomes.
6.3. Healthcare facilities may seek to provide ART services by applying for a new
facility under New HAAD licence application;
6.3.1Application for New Licence for ART services is available under the
Facility Category “Fertilization Centre”
(http://www.haad.ae/haad/tabid/854/www.haad.ae/haad/tabid/127/Default.aspx );
6.3.2 Applicants approved to provide ART services will be issued with a HAAD
licence specific for the ART services type(s);
6.4. Healthcare providers - Eligibility criteria for HAAD Licensure to provide ART
Services in the Emirate of Abu Dhabi comprises of the following elements:
6.4.1 satisfying the HAAD requirements for healthcare facility licensure
[http://www.haad.ae/haad/tabid/857/Default.aspx ];
6.4.2 satisfying the technical conditions and specifications, with specific
focus on Articles 6-16 of Cabinet Decision No. (36) of 2009 Issuing
the Implementing Regulation of Federal Law No. (11) of 2008
Concerning the Licensing of Fertilization Centres in the State. HAAD
will assess applications for IVF centres against the requirements of
this decision taking into account provisions for site, content and
design, equipment and devices and the requisite specialized HAAD
licensed professionals;
6.4.3 satisfying the specifications of this Standard in terms of ability to
demonstrate evidence of having in place policies, standard
operating procedures and clinical care pathways and quality
governance structures to support compliance with the licensing
requirements.
6.4.4 Policy requirements include:
6.4.4.1 Standard operating protocols for all clinical treatments
offered;
6.4.4.2 Written patient information on any treatments offered;
6.4.4.3 Written patients information on any risks associated with
treatments;
6.4.4.4 Standard operating protocols for management of adverse
outcomes;
6.4.4.5 A policy for reduction of high order multiple pregnancies.
6.5 Clinical Laboratories: All ART laboratories licensed by HAAD must have:
6.5.1 Standard operating protocols for all laboratory procedure;
6.5.2 Risk assessments for laboratory procedures.
6.6 Healthcare professionals - The licensed Healthcare facility must meet the
following:
6.6.1 All healthcare professionals are licensed by HAAD;
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6.6.2 Satisfy the mix of specialised healthcare professionals stipulated by
Article 8 of the Cabinet Decision No. (36) of 2009 Issuing the
Implementing Regulation of Federal Law No. (11) of 2008
Concerning the Licensing of Fertilization Centres in the State;
6.6.3 The ART service is provided by a HAAD licenced Consultant
accredited by a HAAD recognised body specialising in the field of
assisted reproductive technologies (ARTs);
6.6.4 Specialist Physicians with specialisation in assisted reproductive
technologies may provide IVF services under the following
conditions:
6.6.4.1
The Specialist possesses evidence in support of their
specialisation in ART treatment;
6.6.4.2
the Specialist is supervised by a HAAD licensed Consultant
specialising in ARTs;
6.6.4.3
the Specialist does not treat patients that have been
identified as high risk; and
6.6.4.4
the Specialist undergoes a quarterly performance review
by the supervising Consultant;
6.6.4.5
The ART service is provided by a HAAD licenced
Consultant/Specialist and embryologist specialising in the
field of assisted reproductive technologies (ARTs);
6.6.4.6
Providers are required to present evidence to HAAD, when
requested, on achieving quality and safety through
records on the number of ART cases performed per
licensed embryologist per day, and demonstrate that
these are comparable to international evidence based
best practice;
6.6.5 All healthcare professionals must practise within the specified scope
of services of their facility, the job duties assigned to them by their
employing facility and the privileges granted in accordance with the
requirements of the HAAD Clinical Privileging Framework Standard.
6.7 Provision of ongoing care
6.7.1 The centre will have in place a written agreement with a named
gynaecologist and admitting hospital for admission of all cases that
require hospital assessment, treatment or admission as a result of
treatment carried out in the IVF centre.
7. Standard 2 – Storage of Gametes
7.1. Facilities and documented procedures
7.1.1. The HAAD licensed facility must establish documented procedures to
ensure that all storage and handling of gametes comply with licenced
conditions, Federal Regulations, and relevant patient consent as per section
9;
7.1.2. The centre should ensure that the storage facilities for gametes are
7.1.3. are dedicated for the purpose, and adequate for the volume and types of
activities;
7.1.4. are designed to avoid proximity to ionising radiation (radioactive material),
any known potential source of infection, or chemical or atmospheric
contamination;
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7.1.5. have a storage-location system that minimises the amount of handling
required to retrieve gametes; and
7.1.6. have a system in place for specimen tracing.
7.1.7. The HAAD licensed facility must have emergency management procedures
to deal with damage to storage vessels, failure of storage conditions or both;
7.1.8. The HAAD licensed facility must have documented procedures to ensure:
7.1.8.1. gametes are stored under controlled conditions that are validated
and monitored;
7.1.8.2. gametes are packaged for storage in a way that:
7.1.8.2.1.
prevents any adverse effects on the material;
7.1.8.2.2.
minimises the risk of contamination;
7.1.8.2.3.
records are kept indicating every occasion when gametes
are handled during storage and release, and by whom
records are kept indicating that gametes meet
requirements for safety and quality before release; and
7.1.8.3. risk assessments (approved by the director of the ART facility) are
done to determine the fate of all stored material whenever any of the
following is introduced:
7.1.8.3.1.
a new processing step to enhance safety, quality or both;
and
7.1.8.3.2.
a new procedure for appropriate disposal of gametes.
7.2. Safety of equipment used to store cryopreserved gametes.
7.2.1. The HAAD licenced Facility must store gametes in a designated area;
7.2.2. Access to this area must be limited to staff authorised under the terms of
the facility’s licence. Cryopreservation dewars should be fitted with local
alarms and be linked to an auto-dial or similar facility, (e.g. a link to a fire
alarm board) to alert staff to non-conformities outside normal working hours;
7.2.3. The facility must have adequate staff for an ‘on-call’ system for responding
to alarms out of hours, and adequate spare storage capacity to enable
transfer of samples if a dewar fails;
7.2.4. A Facility storing gametes s for patients whose future fertility may be
impaired by a medical condition or procedure must divide individual
patients’ samples into separate storage vessels, in case of dewar failure.
7.3. Information, screening and storage of specimens to prevent cross contamination.
Centres must:
7.3.1. assess the risks of cross-contamination during the quarantine period;
7.3.2. put procedures in place to minimise these risks; and
7.3.3. document the rationale for the chosen quarantine procedures;
7.3.4. If the treatment involves the creation of embryos in vitro, the centre must
inform the patients that embryo freezing is not permissible under UAE law
under any circumstances;
7.3.5. If there is an intention to store gametes, or where this possibility arises
during treatment, in addition to relevant information about treatment, the
centre must give those providing the gametes relevant information about:
7.3.5.1. the possible deterioration or loss of viability of gametes as a result
of storage, and the potential risk of cross-contamination between
samples;
7.3.5.2. Federal regulations for statutory storage periods for gametes;
7.3.5.3. the likelihood of a live birth resulting from previously cryopreserved
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gametes; and
screening tests to be done, the cost of these, the reason for them
and the implications of the tests for the gamete providers.
7.3.6. The HAAD Licenced facility must provide specific information tailored to
the needs and circumstances of oncology patients and other patients
requiring long-term storage. Where relevant, this should include information
appropriate to minors.
7.3.7. The HAAD Licenced facility must ensure that, before a couple consents to
gametes being stored, they are informed of:
7.3.7.1. the options available if a person providing gametes or resulting
embryos dies or becomes mentally incapacitated;
7.3.7.2. that it may be possible to register a deceased partner as the parent
of a child resulting from treatment, and the conditions for doing so
subject to completion of form 2&3 in the fertilisation law; and
7.3.7.3. that it is unlawful to store gametes beyond the period of five years,
the centre having a legal obligation to dispose of them once this
timeframe has expired.
7.4. Treatment using cryopreserved eggs
7.4.1. Embryos created from cryopreserved oocytes may not be cryopreserved as
per UAE law;
7.4.2. Patients must be given data on oocyte survival rates and fertilisation rates
from the individual centre.
7.5. Consent to storage and cases where consent is not required for storage.
7.5.1. The law requires the centre to obtain written informed consent from a
person before it stores their gametes; and
7.5.2. Gametes stored following the application of ART may be used only if the
couple gives written effective consent to their use (and has sufficient
capacity and competence to do so);
7.5.3. HAAD recommends that providers licensed to provide ART undertake yearly
recall and re-consent for storage of gametes.
7.6. Extension of storage. Before the HAAD licensed facility obtains consent from
anyone wishing to store gametes up to 5 years, it should ensure that the
conditions for storage as per Federal Law number 11 for Fertilisation (2008) are
satisfied;
7.7. Disputes involving the withdrawal of consent to storage
7.7.1. if one of the gamete providers withdraws consent to the continued
storage of gametes intended for treatment (created from their gametes),
the healthcare facility must take all reasonable steps to notify both
recipient(s) prior to disposal;
7.7.2. If the marriage status of the gamete providers is no longer valid, the law
requires the centre to take and evidence all reasonable steps to notify
both recipient(s) prior to disposal.
7.8. Storage review. The centre should establish documented procedures to ensure
that:
7.8.1. reviews of stored gametes are done at least once every year to:
7.8.1.1. reconcile the centre’s records with material in storage;
7.8.1.2. review the purpose and duration of storage; and
7.8.1.3. identify any action needed.
7.8.2. The HAAD licensed facility must operate a bring-forward system in order to
7.3.5.4.
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ensure sufficient advance notice of the end of the statutory storage period
(or such shorter period as specified by a person who provided the
gametes) for gametes in storage.
7.9. The end of storage
7.9.1. No HAAD licensed facility shall store gametes after the expiry of the legal
maximum storage period of 5years, or the period specified when the
gametes were stored, if shorter;
7.9.2. The centre should make efforts to stay in contact with patients who have
gametes in storage for their own treatment. The centre should also explain to
gamete providers and current patients the importance of informing the
centre of any change in their contact details;
7.9.3. Centres should inform patients who have gametes in storage for their own
treatment when the end of the permitted storage period is approaching.
Patients must be provided with information about the options available to
them as the end of their permitted storage period approaches. They should
be given enough notice to enable them to consider those options, and to
access appropriate advice.
7.10. Disposal of Gametes. A written consent by both husband and wife will be
obtained prior to the disposal of gametes.
8. Standard 3 – Service Model
8.1. Healthcare providers must ensure that their services and management systems:
8.1.1. Underpin a drive for continuous improvement in clinical quality, and are
capable of tracking performance, including trends in clinical
quality/outcomes for patients by documenting the detailed reporting
specifications provided at Appendix 1;
8.1.2. Ensure monitoring data are maintained for audit purposes as per
Appendix 2;
8.1.3. Provide seamless care in partnership with other providers, including
primary care and hospitals, as required for holistic patient care; and
8.1.4. Facilities and professionals licensed by HAAD to undertake ART must
evidence, on an annual basis, their commitment to adopt and work toward
international best practice, such as that established by The Human
Fertilization and Embryology Authority (HFEA), whilst maintain compliance
with Federal Law number 11 for Fertilisation (2008) and this Standard.
9. Standard 4 – Principles of Care
9.1. Couples experiencing fertility problems must be seen together as decisions
surrounding investigations and treatment will affect both partners;
9.2. Patients must be offered information leaflets, which must be available in the
clinic, regarding the nature of investigations, diagnosis and treatment likely to be
required. These must be available in both English and Arabic as a minimum;
9.3. The clinic must provide a supportive environment that recognises the personal
and cultural sensitivities associated with infertility and couples’ needs for privacy,
confidentiality and quiet areas for counselling in order to minimise psychological
stress is;
9.4. The clinic must provide access to both English and Arabic qualified healthcare
professionals and staff that can support decision making process and provide the
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needed guidance and information on treatment, care and follow up procedures
and resources;
9.5. Couples must be given a clear diagnosis prior to fertility treatment;
9.6. Couples must be given a “cooling off” period of at least a week between
diagnosis and initiation of treatment so that they have the ability to read the
investigations and information sheets provided to them. Treatment specific
consent forms must be given to the couples to take away and read;
9.7. Consent must be undertaken at each decision making point (treatment and/or
storage) and must be clearly documented by the treating physician in the
patient notes; evidence of patient/couple written consent must also be
documented.
9.7.1. Separate consent for Treatment must be obtained for the following:
9.7.1.1. Consent to undergo ART treatment and treatment type (couples);
9.7.1.2. Consent from the wife to use her eggs for her treatment;
9.7.1.3. Consent to use husband’s sperm for his wife; and
9.7.1.4. Couples consent to transfer embryo(s) into the Uterus or Fallopian
tube.
9.7.2. Separate consent for Storage must be obtained for the following:
9.7.2.1. Consent to the storage of wife’s eggs;
9.7.2.2. Consent to the storage of husband’s sperm;
9.7.2.3. Consent for using husband’s sperm following storage;
9.7.2.4. Consent for using the wife’s eggs following storage;
9.7.2.5. Consent to extending the storage of your sperm (maximum 5years);
and
9.7.2.6. Consent to extending the storage of your eggs (maximum 5years).
9.8. Couples must be given information on IVF treatment options and associated risks
and the likelihood of successful pregnancy;
9.9. Couples must be provided with clear information on diagnosis and management
options. This information must also include the associated risks (Appendix 3). The
most effective and least risk associated procedure must always be offered as a
first line treatment option;
9.10.Multiple pregnancies should not be regarded as the ideal outcome of IVF
treatment and this must be explained to the patient prior to treatment. High order
multiple pregnancies (i.e. triplets and above) must be reported to HAAD as a serious
untoward incident (Appendix 4);
9.11 Where ovarian hyperstimulation syndrome is proposed, a risk assessment must be
undertaken before treatment starts and women identified to be at risk must have a
clear treatment plan that outlines the risk reduction strategies;
9.12.Couples must be given advice on their fertility potential in line with evidence
based practice;
9.13. Investigations and interventions must be based on the latest evidence and
guidelines;
9.14. Patients must be offered counselling prior, during and after assessment or
treatment. This must be undertaken by a HAAD licensed clinician specialised in
ARTs independent of the treatment team;
9.15. Couples must be informed of any procedures that are likely to affect their
fertility and the option to preserve the sperm and/or unfertilised ova by
freezing must be offered;
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9.16. If the woman is aged 35 years or under at the time of transfer, the physician
must not transfer more than two embryos. If a decision is taken to transfer
three of more embryos in women <35 years old, then this must be
documented, stating the rationale and evidence base supporting the decision,
and reported to HAAD (Appendix 1);
9.17. Patients who have a good prognosis for pregnancy (i.e. women <30 years old
or couples with unexplained infertility), a single embryo transfer should be
considered;
9.18. When used in ART, frozen unfertilised ova must not exceed 5 years;
9.19. Labs licenced by HAAD must have in place a written procedure approved by
the nominated Director to manage the ICSI cases and ensure quality and
patient safety are prioritised. Providers are required to present evidence to
HAAD, when requested, on achieving quality and safety through records on
the number of ICSI cases performed per licensed embryologist per day, and
demonstrate that these are comparable to international evidence based best
practice;
9.20. The treating physician must take account of potential adverse obstetric
outcomes and complications, such as early pregnancy failure, hyper
stimulation syndrome, and neonatal complications;
9.21. Clinical staff must make clear to patients considering treatment that the
interests of the prospective child are of major importance;
9.22. Both husband and wife must be screened for HIV, Hepatitis B and Hepatitis C
prior to handling of their gametes for ART.
10. Standard 5 - Patient Eligibility Criteria for ART treatment
10.1
The provider must ensure that ART treatment is only provided to patients
who meet the following criteria:
10.1.1 The couple have been trying for pregnancy for at least 1 year or there is
an identifiable factor contributing to infertility;
10.1.2 The couple have undertaken all the necessary lifestyle interventions for at
least one year, with unsuccessful fertility outcomes;
10.1.3 One or both individuals have been diagnosed with fertility problems;
10.1.4 There is a known clinical cause of infertility or a history of predisposing
factors for infertility;
10.1.5 Both husband and wife have consented for IVF treatment;
10.1.6 Both husband and wife commit to undertake the necessary follow up by
an ART Consultant/Specialist;
10.1.7 The wife has a body mass index of between at 19 and up to and
including 35; Women with a BMI of <19 or >35 must be informed of the
increased risk of fertility treatment and risk to pregnancy and child as a
direct result of their physical condition. These women should be referred
for weight management and treatment started only when BMI is between
19 and 35;
10.2. Where patients do not meet the eligibility criteria, clinicians must ensure
patients are given adequate information on the reasons and clinical decision. This
must also be documented in the patients’ medical file;
10.3. Where a couple does not meet the eligibility criteria, a treating Consultant may
request for exceptional cases to be reviewed by an independent expert nominated
by HAAD.
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11 Standard 6 – Access to Care
11.1. There are a number of situations where treatment before one year may be
appropriate:
11.1.1 Pre-disposing factors: Where a woman is 35 years or over or there is a
history of predisposing factors e.g. amenorrhoea, oligomenorrhoea,
pelvic inflammatory disease or with men undescended testes. In these
circumstances earlier investigation and treatment must be offered;
11.1.2 Patient History: Where there is evidence that the couple have already met
the requirements set forth in section 10;
11.1.3 Cancer treatment: Where there is a known reason for infertility (e.g. prior
treatment for cancer) early specialist referral must be offered.
11.1.4 Chronic viral infections: People who are known to have chronic viral
infection (e.g. HIV, Hepatitis B or Hepatitis C) must be referred to HAAD
licensed facilities that have appropriate expertise and facilities to provide
investigation and specialised treatment. Facilities offering treatment for
these couples must have a standard operating protocol in place for
handling specimens from these couples. In general, these couples should
only be treated in a HAAD licensed centre that has facilities, or access, to
specialised ART physicians and specialists in infectious diseases.
12 Standard 7 – Clinical Governance
12.1.The healthcare provider must establish and implement a medical oversight
program that consists of the following as a minimum:
12.1.1 Appointing a Director, who will be responsible to ensure clinical
governance is achieved and will be required to oversee and authorise the
collection, monitoring and reporting of the quarterly KPIs for audit and
payment purposes as per Appendix 1; and oversee a system of continuous
quality and safety improvement;
12.1.2 Ensure monitoring data is reviewed and action plans are developed to
address low performance as per Appendix 2;
12.1.3 Ensuring appropriate and effective mechanisms to coordinate patient
treatment and care with other healthcare providers where required;
12.1.4 Ensuring availability of appropriate mix of multidisciplinary team, its
members possessing the requisite levels of knowledge and skills in
accordance with their role in ARTs, and that staff receive appropriate and
up to date training to support effective patient care;
12.1.5 Ensuring that the facility has standard operating procedures and clinical
practice guidelines/care pathways for the services provided and that
these are effectively implemented and updated;
12.1.6 Ensuring compliance with the HAAD stipulated reporting requirements,
including on KPIs and serious untoward incidents (Appendix 3) associated
with ART treatments (in addition to the requirements for HAAD Standard
for Adverse Events Management and Reporting in the emirate of Abu
Dhabi);
12.1.7 Ensuring that patient complaints are handled as per the HAAD Standard
for Complaints management in Healthcare Facilities.
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Appendix 1 - Clinical Key Performance Indicators and reporting data for IVF/ICSI and PGD
Criteria
Q1
Q2
Q3
Q4
Total
1) Number of couples
starting IVF or ICSI
(including satellite
centres)
2) Number of women
reaching oocyte
retrieval
3) Number of women
reaching embryo
transfer
4) Number of women
having single embryo
transfer
5) Number of women
having 2 embryos
transfer
6) Number of women
having ≥ 3 embryos
transferred
7)OHSS rate
8) Ectopic pregnancy
rate
9) Cycle cancellation
before egg collection
10) Multiple pregnancy
rate
11) High order multiple
pregnancy rate (triplets
and above)
12) Pregnancy rate
13) Clinical pregnancy
rate
14) Live birth rate
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Clinical Key Performance Indicators and reporting data for PGD
1) Number of couples
starting PGD/PGS
2) Number of women
reaching egg collection
for PGD/PGS
3) Number of women
reaching embryo
transfer for PGD/PGS
4) Number of couples
with embryos
transferred
5) Number of women
having single embryo
transfer
6) Number of women
having 2 embryos
transfer
7) Number of women
having ≥ 3 embryos
transferred
8) Pregnancy rate
9) Clinical pregnancy
rate
10) Live birth rate
Facility Name:…………………………………………
Signature ART Director:……………………………….
Date……………………………………….
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Appendix 2 –Monitoring data (quality assurance data)
Criteria
Q1
Q2
Q3
Q4
Total
1) Number of new
patients
2) Number of patients
with unexplained
infertility
3) Number of complaints
4) High order multiple
pregnancy (i.e. triplets
and above)
5) ICSI cycles
7) IUI cycle
8) OHSS
9) Cancelled cycles
10) IVF fertilisation rate
11) ICSI fertilisation rate
12) Blastocyst transfer
rate
13) Survival rate of frozen
thawed oocytes
14) Average waiting
times (weeks)
15) Minor Incidents rate
(number and Percentage)
16) Patient Complaints
rate (number and
Percentage)
17) Infection rate
(number and Percentage)
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18) Method of disposing
surplus ova or unfertilised
ova that are not viable
for implantation
19) Serious Untoward
Incident rate (number
and Percentage)
Facility Name:…………………………………………
Signature ART Director:……………………………….
Date……………………………………….
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Appendix 3 - The potential problems associated with ART.
1. Drug reaction
Most women will have some reaction to the drugs. Most of the time the side effects are
mild and include:

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



hot flushes
feeling down or irritable
headaches
restlessness
nausea and vomiting
shortage of breath
abdominal bloating due to an accumulation of fluid
ovarian hyperstimulation (excessive ovarian response to the gonadotrophins, with
abdominal pain and swelling, shortage of breath and enlargement of the ovaries).
It may be necessary to cancel the cycle and restart with a lower dose of
gonadotrophin.
The treating physician must be informed immediately if you experience any of the above,
especially if you have abdominal pain and swelling.
2. Multiple births
If more than one ova is replaced in the womb as part of IVF treatment, there's an
increased chance of producing twins or triplets.
Having more than one baby may not seem like a bad thing, but it significantly increases
the risk of complications for you and your babies:



Multiple pregnancy can raise your blood pressure significantly.
You're two to three times more likely to develop diabetes during pregnancy if
you're carrying more than one baby.
Around half of all twins and 90% of triplets are born prematurely or with a low
birth weight. The risk of your baby dying in the first week of life is five times higher
for twins than for a single baby. For triplets, the risk is nine times higher.
3. Ovarian hyper-stimulation syndrome
The ovarian hyper-stimulation syndrome (OHSS) is a rare complication of IVF. It occurs in
women who are very sensitive to the fertility drugs that are taken to increase egg
production. Too many eggs develop in the ovaries, which become very large and painful.
OHSS is more common in women under 30 and in women who have polycystic ovary
syndrome. OHSS generally develops in the week after egg collection. The symptoms of
OHSS are pain and bloating low down in your abdomen, nausea or vomiting. Severe cases
can be dangerous. Contact your clinic if you have any of these symptoms.
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4. Ectopic pregnancy
If you have IVF, you have a slightly higher risk of an ectopic pregnancy, where the
fertilised egg implants in the fallopian tubes rather than in the womb. This can cause
vaginal bleeding or bleeding into the abdomen. If you have a positive pregnancy test,
you'll have a series of hormone tests and a scan at six weeks to make sure that the embryo
is growing properly. The treating physician must be informed if you experience vaginal
bleeding or stomach pain after having IVF and a positive pregnancy test.
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Appendix 4 – Reporting Form for Serious Untoward Incidents Related to ART Reporting form
Reporting Facility Name:
Reporting Physician Name:
1) Patient ID
2) Date of referral
3) Source of referral and referrers/clinicians details
4) Patient Date of Birth
5) Patient Address
6) Date(s) of egg collection
7) Number of egg collection
8) Period of egg collection
9) Date of frozen cycle (where appropriate)
10) Patient Outcome(s)
11) Prognosis
12) Additional comments
Page 18 of 18