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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 Page 1 of 18 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; Page 2 of 18 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); Page 3 of 18 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; Page 4 of 18 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; Page 5 of 18 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 Page 6 of 18 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. Page 7 of 18 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 Page 8 of 18 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; Page 9 of 18 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. Page 10 of 18 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. Page 11 of 18 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 Page 12 of 18 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………………………………………. Page 13 of 18 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) Page 14 of 18 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………………………………………. Page 15 of 18 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: 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. Page 16 of 18 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. Page 17 of 18 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