The South African Society for Reproductive medicine and Gynecological Endoscopy (SASREG) is a society that promotes quality fertility care in South Africa. It aims to serve and protect the interest of the patients undergoing assisted reproductive treatment (ART), specifically through in vitro fertilization (IVF) treatment.
The society recognizes the multi-disciplinary nature of reproductive science and medicine, and its members include andrologists, counsellors, social workers, embryologists, nurses, and reproductive specialists.
These disciplines are all subjected to the Ethical Code of conduct set out by the Health Professions Council of South Africa (HPCSA) and governed by the Regulations of the Health Act. As a society of professional peers, SASREG does not hold any statutory powers.
A multi-disciplinary task team was established to compile this South African-specific standards document. This process was drafted with the guidance of an internationally recognized expert and advisor on accreditation standards, Dr David Mortimer, from an ART-focused consultation company Oozoa Biomedical Inc.
The Standards aim to provide a framework and set criteria for SASREG accreditation. The most important perspective of this new accreditation scheme is that it does not aim to simply checkboxes but rather reviews the monitoring and control systems that an IVF facility has in place to ensure that good quality care is provided at every phase of treatment. Therefore, certain Required Operational Procedures (ROP) establish a minimum standard that needs full compliance to receive accreditation.
SASREG will ensure that the surveying process is carried out independently, non-adversarial and constructively. The accreditation process remains voluntary. The Standards remain a living document and will develop over the coming accreditation cycles to ensure the scheme remains relevant and current as our field advances and our quality services of ART care progress and expands.
Special thanks to all the contributors for compiling these standards during 2021.
SASREG Accreditation Sub-Committee
- Chairperson: Ms Lydia Els-Smit
- Vice-Chairperson: Dr Chris Venter
- Committee Members: Dr Jack Biko, Mr Gerhard Boshoff, Dr Yusuf Dasoo, Ms Marisa Marais, Prof Igno Siebert
SASREG Presidency
- President: Dr Jack Biko
- Vice-President: Dr Chris Venter
Compilation of the Standards
The compilation process took place over the course of 2021. Our contributors were colleagues from our country and several IVF clinics and institutions under the guidance of an internationally well-known expert to ensure we applied accreditation principles to the South African context for ART in our country.
| Clinical | Nursing | Laboratory | Counselling |
|---|---|---|---|
| Dr Jack Biko | Sr Hanlie Monnery | Mr Gerhard Boshoff | Mandy Rodrigues |
| Dr Ysuf Dasoo | Sr Cyndi Nel | Ms Lydia Els-Smit | Daksha Hargovan |
| Dr Gerhard Hanekom | Sr Izaan Venter | Mr Neville Moodley | |
| Dr Johannes van Waart | Dr Michelle Rijsdijk | ||
| Dr Chris Venter | Ms Marisa Slabbert |
Standards and Accreditation Documentation
The Accreditation Process and Standards consist of three (3) important documents.
- Accreditation Standards for IVF Centres 2023-2026. This document includes information regarding interpreting the Standards and the accreditation process and outcome.
- SASREG Application Requirements. This includes information on how to self-assess the standards and requirements for the application.
- A Resource Page containing the articles in PDF format of the reading list referenced in the Standards document. These documents are available for print/download without any copyright infringement. These documents require the attention of all staff in the organization to understand the process and relevant staff involved in each department.
SASREG members can contact Lethisha at Turners to receive a password to access the Resource Page.
Interpretation of the Standards
The Standards are divided into the functional departments of the organization, i.e., Clinical Services, Nursing Services, Laboratory Services and Counselling. The document also includes a section dedicated to the overarching aspects related to the management of the facility.
Some sections might not apply to every organization and thus should be indicated as such in the Self-Assessment.
The Standards aim not to delve into details of what is done or how but instead seeks an explanation of monitoring or quality control system that are in place and evidence that they are being followed.
Each department has been sub-divided to cover six main areas, namely,
- Facility, Planning and Design
- Qualifications and Staff structure
- Equipment and Consumable Management
- Processes and Procedures
- Information, Communication and Feedback
- Risk and Emergency Management
- Informative/Authoritative References
The list of Informative or Authoritative References allows the organization to refer to the guidelines and regulations relevant to that section. Each of the sections has been compiled by our own colleagues from several ART clinics across South Africa. Having our own contributors ensured that our Standards were in line with most international guidelines and according to our country’s context. Thus, the references are also a reading list aiming to expand knowledge. Electronic versions of the South African government gazettes and guidelines are available on Resource Page.
Specific Standards have been drawn up to address these main areas within each department. Each Standard is in a table format and is laid out into the following headings to describe it:
- Standard name
- Standard Statement or Goal: To give a clear aim of the Standard.
- Intent: What the Standard intends to achieve and/or reason for the importance of the standard.
- Interpretation Guidelines: Explanatory details on what the Standard entails, practical aspects, and examples.
- Supporting Information: The information that will be needed as evidence for achieving the goal of the Standard. Information provided as part of the self-assessment and evidence reviewed during the survey will be used to assess compliance with each Standard.
Several Standards were identified as essential for accreditation and have been marked as “Required Operational Practices” (ROPs). This is indicated in the top right of each Standard table and the table of contents before each section. These ROP Standards will require full compliance to achieve accreditation. Some of these are related to regulatory requirements, while others are related to the health and safety of staff and/or patients. Non-ROP Standards may become ROPs in future accreditation cycles.
Compliance with the Standards
Each organization will need to comply with the Standards.
There are four (4) levels of compliance that can be reached per Standard at assessment. These are as follows with their interpretations:
- Fully compliant: All aspects met according to the supporting information assessment.
- Largely compliant: Minor aspects need attention, but no ‘must’ actions need to be remedied.
- Partially compliant: Requires at least one “must” action recommendation that will need to be dealt with to be accredited.
- Non-compliant: One or more “must” actions are required that must be resolved quickly for accreditation to be considered; if there are too many “non-compliant” items, then accreditation could be withheld.
The organization must achieve at least ≥90% Fully and Largely compliance ratings to ROP Standards and
≥70% Fully and Largely Compliant ratings for non-ROP Standards for successful full accreditation.
Application & Fees
The organization can apply for accreditation by following the application steps in the Application Process.
The application will entail the completed Self-Assessment Document and payment of prescribed accreditation fees.
The fee for accreditation will be divided across the period of four (4) years from application.
The fees include the travel and accommodation expenses of the surveyor team for the survey visit and their remuneration.
- Year 1: R10 000 payable at the time of 1st application,
- Year 2: R5 000 payable after 12 months from the 1st application date
- Year 3: R5 000 payable after 24 months from the 1st application date.
The fees are irrespective of the accreditation status awarded since the accreditation process will be ongoing to achieve compliance for full accreditation.
Surveys & Surveyors
The survey will take place over at least one full day at the organization, depending on the ease of seeing the supportive information. At the end of the survey, the surveyors will have a feedback session with the clinic as an exit meeting to briefly discuss their most important observations.
The survey will be performed by an appointed team of surveyors consisting of a clinician, an embryologist, a counsellor, and maybe a nurse. The Nursing section will typically be surveyed by the clinical surveyor, with an off-site nurse surveyor available for consultation if required.
There are currently a few of our expert colleagues that are willing to act as surveyors for this accreditation term. However, their availability may change, and thus the surveyor team may change. The Accreditation Sub-Committee nominates and formally invites surveyors to ensure the pool of surveyors is sufficient. Surveyors are volunteers and are remunerated for their survey work as per agreed by the committee.
| Clinical & Nursing | Laboratory | Counselling |
|---|---|---|
| Dr Paul Dalmeyer | Mr Gerhard Boshoff | Daksha Hargovan |
| Prof Silke Dyer | Dr Marie-Lena De Beer | Mandy Rodrigues |
| Dr Malika Patel | Prof Carin Huyser | Tania Rubin |
| Sr Cyndi Nel | Ms Marisa Marais | Leanne van der Westhuizen |
The Accreditation Outcome
The final outcome of the accreditation survey will be a result of a process where the survey is reviewed by the Accreditation Committee, and a final report is submitted for approval by the SASREG Board. The Accreditation certificate will be issued accordingly. Any complaints from the organization regarding the survey should be addressed to the Chair of the Accreditation Committee.
In case of Provisional Accreditation being awarded, the indicated required supporting information and evidence must be submitted on time per the survey final report to receive full accreditation.
Full accreditation is valid for four years, after which the survey process will be repeated according to updated Standards that will apply to the following accreditation term.