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Section 126.96.36.199.5 (q) on page 2 needs to make reference to a standard to be meaningful. A standard exists. This standard should be referenced as follows: Where applicable, gametes (sperm, eggs or embryos) should be acquired, stored and used in compliance with CAN/CSA-Z900.2.1: Tissues for assisted reproduction.
Reference could also be made on Page 3 under items 5 and/or 6
For stand alone IUI/ICI units, Section 188.8.131.52.5 needs to be replicated in the Standards, again with reference to the CSA standard.
If these standards become part of federal regulations, is there anyplace in the document that refers to compliance with federal regulations. Currently the only federal regulations are the semen regulations, but this is about to change.
There have to be clearer measures of success for IVF that are universally shared among clinics, recognized as credible by patients, and reflective of the outcomes patients’ desire and the ultimate goals of the reproductive journey they embark on (i.e., a healthy baby [cumulative live birth rate] not just live birth rate per cycle or whether they got pregnant [clinical pregnancy rate]). Absent standardization of these metrics the CPSO will find it difficult to compare outcomes across clinics and ultimately to assess quality of practice. The same need applies to ART trials and was a recommendation made in a recent Cochrane review.
Abuzeid MI, Bolonduro O, La Chance J, et al. Cumulative live birth rate and assisted reproduction: impact of female age and transfer day. Facts, Views & Vision in ObGyn. 2014;6(3):145-149.
Pandian Z, Gibreel A, Bhattacharya S. In vitro fertilisation for unexplained subfertility. Cochrane Database Syst Rev 2012;4:CD003357.
At some point it is necessary for the CPSO and the people it represents to trust physicians that they are doing the best they can. Inspecting for gynecological procedures (of which an IUI is one of ) is as unncessary as checking for IUI and PAPs. Isn’t the money better allocated to other important areas?
BORN OntarioThank you for inviting commentary on the proposed OHPIP standards related to Fertility Clinics. [Names redacted] from BORN Ontario reviewed the document. Our feedback is as follows:
• P ii, b.1 – we think that this should be expanded to include fertility preservation for medical and non-medical purposes
• P. 2 – in the first text box under 184.108.40.206.1 e) – this doesn’t seem grammatically correct
• P. 20 – it talks about BORN data but the context isn’t quite correct. Perhaps it would be more accurate every time this point is raised in the document to say the following:
• The clinic is expected to submit standardized data for each IVF cycle to BORN.
• BORN data (either standardized reports or dashboard data) available in the BORN reporting portal should be available for inspection if requested
Similarly, the idea that an IVF clinic has the option to not to submit all cycle data is not really correct. In Ontario, clinics who receive funding are compelled to submit data to BORN and in fact, all were submitting anyway in advance of this initiative as they recognize the importance of measuring outcomes and peer comparison. However, we do think the standard should be that CPSO should require all IVF clinics in Ontario to submit data to BORN, regardless of funding status. This would be important as new clinics decide to set up in allowing us to monitor all outcomes in Ontario.
• P. 21 specifically point 3c relates to IUI. As you know we don’t currently collect this, nor have we been given any direction from the MOHLTC that they have reached any consensus on this. However we believe it is important to have a mechanism to report and monitor data for IUI. This will require a partnership between CPSO, the MOHLTC, BORN and individual care providers and clinics.
• In the IUI section (p. 37) where quality is discussed, again refer to the point above. We do not currently have dashboard indicators or data collection to this point for IUI, but believe it would be valuable.
If you have any questions about our feedback, feel free to contact us.
College of Nurses of OntarioThank you for providing the College of Nurses of Ontario (CNO) the opportunity to provide feedback on the draft document titled Applying the Out-of-Hospital Premises Inspection Program (OHPIP) Standards in Fertility Services Premises.
We would like to share with you the following suggestions which pertain specifically to content related to nurses:
Page 3: The document references four CFAS position statements by title, but these position statements are not available on the “position statements” section of the CFAS website:
If the intent is that these documents will be included as an appendix to the nursing manual, you may wish to direct readers to where they can be found.
Page 9: The clarification for Standard 5.6.1 (for “nurse qualifications”) refers to “delegated medical acts (if appropriate, e.g., donor or partner sperm insemination and/or IUI)”. CNO suggests either removing the term “delegated” from this statement or changing the example in parentheses to reflect a controlled act for which a nurse would need delegation to perform.
If a procedure falls under one of the four controlled acts that are authorized to RNs and RPNs through the Nursing Act, 1991, (e.g., the insertion of a hand, finger, or instrument beyond the labia majora), an RN or RPN does not require delegation to perform the procedure. In this case, the RN or RPN would only require an order (e.g., from a physician).
An RN or RPN would only need delegation if she/he were to perform a controlled act that is not authorized to RNs and RPNs through the Nursing Act, 1991. For example, an RN or RPN would need delegation if she/he were going to perform the controlled act of applying a form of energy. For more information, please see CNO’s Authorizing Mechanisms practice guideline:
Page 12: The text on the left-hand side of the page states that “…a Nurse or Physician may be responsible for the requirements listed in table 06” but the far-right column in table 06 (labelled “Responsibility”) states “Physician performing procedure” which suggests that a physician, not a nurse, is responsible for the requirements in Table 06.
Additionally, point #4 in Table 06 states that “The physician is responsible for obtaining informed consent and a procedure consent form signed by the patient or substitute decision maker and witnessed.” If any or all of the requirements in Table 06 are
intended to be the responsibility of a physician, and not a nurse, the statement on the left-hand side of page 12 should be revised so it does not state that a nurse may be responsible for these requirements.
Page 17: The following sentence requires consideration for revision: “An anesthesiologist or another physician is responsible for writing the discharge order. However, the actual decision for discharge from the recovery area must be based on discharge criteria using an objective scoring system; the decision can be delegated to recovery-area staff (such as RNs).”
Delegation refers to the transfer of authority to perform controlled acts. Discharging a client is not a controlled act, so it does not require delegation in order to be performed by an RN. However, it is unclear why a physician would be responsible for writing a discharge order if that discharge order is separate from the decision to discharge, which is identified as something that could be the responsibility of an RN. If the decision to discharge is the responsibility of the RN, what is the purpose of the physician’s discharge order and to what extent is the physician who wrote the order accountable for the discharge? If the RN is responsible for the decision to discharge, why is she/he not also responsible for the discharge order?
To ensure clear accountability among the individual care providers, we recommend that the responsibility for the decision to discharge and the responsibility for the discharge order not be separated. If the client should not be discharged without a physician’s order and if the client should not be discharged before the criteria in the objective scoring system have been met, then you may consider stipulating that the physician write a discharge order after he/she has made a decision to discharge based on the result of the objective scoring system.
Page 30: See comments for content on page 9 (re: “delegated”).
Page 34: See comments for content on page 17 (re: discharge order).
If you have any questions or if you require any further clarification, please feel free to contact me.
I have participated in CPSO assessments of physicians’ care for fertility patients and I laud the introduction of a robust quality and safety framework for fertility services. However, I am concerned that the CPSO, an organization that regulates clinical medicine, does not have the required intrinsic expertise or the relevant experience in the key area of embryology laboratory specific metrics. Provision of quality embryology lab services should be treated as the independent skill set that those of us in the field know it to be. We IVF providers respect our laboratory colleagues for an expertise that we do not expect to attain as physicians The CPSO can help physician fertility service providers by providing standards and best practices for medical services, but it is out of the scope of the CPSO to address laboratory quality. This is out of the domain of the physician and thus the physician regulators. Furthermore, while there are differences in out of hospital and in hospital units, it would be shortsighted to have a focus on inspection-assessments based on OHPIP Standards, which were developed for vastly different patient populations, procedures and purpose. To this point, comments by others have highlighted many errors and omissions of fertility specific details. It would not serve patients in Ontario or the CPSO if it were seen to be controlling areas of care beyond its range.
Professional Association of Residents of OntarioResponse in PDF format.
Thank you for inviting commentary on the proposed standards.
Page 8 OHP physical standards – embryology
In addition to provide clean air (low particles level), the ventilation system of the embryology laboratory should be designed to reduce volatile organic compounds (VOCs) detrimental to gametes and embryos.
Page 10 OHP staff qualifications – laboratory staff qualification
To note that in an unionized environment, the manager (lab director) is not allowed to do the work of a unionized employee (embryologist). It would therefore be important to add flexibility to the proposed standard to reflect this reality. I would refer CPSO to the guidelines published by CFAS where the Scientific Director or an “hands-on” Lab Director is the person responsible for the services provided by the Laboratory. Other (unionized) leadership positions, such as Laboratory Supervisor, Coordinator or Lead might be required depending on the volume of activities performed by the laboratory as well as the diversity and complexity of those activities. Some laboratories might focus on routine procedures where other laboratories might include more experimental procedures as well as participating in clinical trials or collaborating in basic science research projects. The various levels of leadership might not be necessary in smaller laboratories or laboratories focused on routine procedures.
CFAS Guidelines for qualifications and responsibilities for each ART laboratory professional position in Canada, 2009.
Page 18 procedure standards for embryology
“The use of all biological material should be verified by two witnesses prior to their use”. It is assumed that this means the person using the material and one witness. Such an approach might not be feasible in all situations (e.g. weekend shift, small laboratories). The standard could include the use of an electronic witnessing system as an appropriate witnessing protocol.
Canadian Fertility and Andrology SocietyComments on CPSO standards for Fertility Services
As a national Society, the Canadian Fertility and Andrology Society (CFAS) represents over 700 medical, scientific, and allied health professionals across the country who work in the field of assisted reproduction. As a Society, we support programs that promote quality and safety in fertility services delivered in Ontario and the rest of Canada. We are also pleased to see an organization like the CPSO take the lead on this initiative. The CFAS has a vested interest in ensuring Canadians receive the highest quality of care and that the health of children born of reproductive technologies remains at the forefront of any standards or regulations. For this reason, we maintain a keen interest in how the standards are developed, applied, and implemented by the College.
The CFAS and its many members are continually engaged in activities that enhance the practice and quality of services delivered through fertility centres. One of our key strategic priorities is to develop standards that guide the safe and effective practice of assisted reproduction in Canada. Some of the ways we have achieved this include:
• Development of Clinical Practice Guidelines for physicians
• Development of standards of practice for counselling of patients who use assisted reproductive technologies
• Publication of competencies and qualifications for embryologists, andrologists, and lab directors
• Development of competency exams for embryologists and andrologists (in progress)
• Development of competency guidelines for fertility nursing (in progress)
• Establishment of standards of care for fertility nurses (in progress)
• Publication of guidelines for lab processes such as transportation of frozen gametes
• Establishment of recommendations for the standardized presentation of clinical pregnancy rates from IVF
In addition to our efforts within the Society, many of our members are actively engaged as advisors on various committees and expert panels, including the Canadian Standards Association which recently published standards on “Tissues for Assisted Reproduction” (Z900.2.1).
In short, the CFAS is uniquely positioned to offer evidenced based and objective support for development of guidelines and standards pertaining to delivery of fertility services. As a multidisciplinary Society focused solely on fertility care, we can provide resources and expertise not readily available from other sources. We are also able to facilitate the adoption and application of standards within the field, especially as standards will affect all specialties and allied health professionals working in assisted reproduction. Therefore, with this correspondence, we respectfully submit our feedback, but also request an opportunity to work directly with the College as it delves into developing an inspection program. Our input and support for this initiative would be valuable to the College, fertility centres, the MOHLTC, and the public especially given the pace of change within the field of assisted reproduction. Further, we will endeavour to support programs in other provinces while ensuring consistency across the country.
Feedback on Adapted OHPIP Standards
The commitment of the Ontario Fertility Program, as described on the Government of Ontario web site (www.health.gov.on.ca/en/public/programs/ivf/), is to ensure proper safety and oversight of fertility services in Ontario. Specifically, the government has made the following commitment:
“To establish a stronger quality and safety framework for the fertility services sector, the government is working with the College of Physicians and Surgeons of Ontario (CPSO) to ensure the highest-quality fertility services.”
The CFAS feels strongly that a simple adaptation of the OHPIP program for fertility services will be inadequate to meet those goals. In its report to the MOHLTC in June 2015, the expert advisory panel specifically highlighted the importance of implementing a comprehensive quality assurance framework as a means to protect the patient and resulting offspring. The CFAS agrees and would therefore like to see standards that clearly identify quality assurance in all areas related to the delivery of fertility care. While additional Quality Assurance (QA) requirements are sited in the manual (after Section 8.1), more detail is required to ensure consistent QA measures exist among all fertility centres in Ontario. Currently, quality assurance standards for the lab are too vague.
While the CPSO has considerable experience in those areas related to medical procedures and infection control, we appreciate that developing quality standards for embryology and andrology lab services for assisted reproduction is a new endeavour. Standards must do more than ensure a minimum safety standard in the lab environment (infection control procedures, safety of medical devices), but serve to ensure quality output of the lab itself. To this end, lab standards already exist for Assisted Reproduction as developed by Accreditation Canada. These standards have already been successfully applied by many fertility centres across the country and are used as the basis for licensing fertility clinics in Quebec. They have been developed and tested over many years and serve as an effective program to guide safety and quality practices in a lab environment. We strongly encourage the College to work with Accreditation Canada and the CFAS to incorporate standards of interest to the College with those already developed by Accreditation Canada. We believe this is in the best interest of patients and that it reflects a responsible and accountable model.
We appreciate that the College has made some important changes to the OHPIP based on its past experience with fertility centres. However, extension of the OHPIP to fertility clinics without modification is not optimal. Application of standards that are well-suited to other out of hospital premises may inadvertently be detrimental to quality of fertility care. For instance, as human reproductive material and in vitro embryos are particularly susceptible to environmental conditions and volatile organic compounds and chemicals, some standards that are appropriate for operating rooms would be detrimental for fertility clinic procedure rooms and embryology laboratories. The CFAS has the requisite expertise and can assist the College in the development of appropriate standards for fertility clinics.
Qualifications of personnel involved in the delivery of fertility care
The current OHPIP document does not identify qualifications for non-medical personnel working in the field of assisted reproduction. Hence, we are uncertain how this standard will be developed and applied. Currently, no national or provincial standards exist that identify qualifications of non-medical personnel working in assisted reproduction. Furthermore, there are no national training programs designed to train people working in andrology, embryology, or fertility nursing. The CFAS has developed competencies and qualifications for embryology and andrology personnel and is currently working on competency guidelines for fertility nurses. The CFAS can assist the College in adopting standards for these and other non-medical personnel to ensure greater consistency among fertility clinics. Again, such an initiative would go a considerable way to supporting the goals of the Ontario Ministry of Health with respect to the Ontario Fertility Program.
Quality assurance and safety are not reasonable objectives without a robust framework for measuring outcomes. The CPSO companion document does reference the Canadian Reproductive Technologies Registry (CARTR) – Better Outcomes Registry & Network (BORN) Ontario, which is currently the best source for data on IVF outcomes. As has already been noted by BORN, a database does not currently exist for Intrauterine insemination procedures. Therefore, it is unclear what resources, if any, will be made available to broaden the scope of BORN. Until then, there remains no way to analyze data beyond the data tracked by individual clinics. We support development of a national (or provincial) database for IUI outcomes and recommend that the province, CPSO, CARTR-BORN, and CFAS establish a taskforce to determine how to achieve this without causing undue financial burden for BORN and the fertility clinics.
While the College has referenced CARTR-BORN in its companion document, it is unclear how it will reference the database in the licensing process. Will the College set outcome targets for IVF? As a Society, clinics have been working collaboratively to share data with the aim of improving outcomes – including negative outcomes such as multiple pregnancy rates. We strongly encourage the CPSO to work with the CFAS, CARTR-BORN and the MOHLTC to better define the role of data collection and outcomes. Furthermore, we believe that there must be a mechanism to ensure the integrity of the database itself before making it a critical aspect of the inspection program.
Any inspection program must consider the multifaceted aspects of fertility treatment. We hope that we have made a strong argument in support of developing appropriate laboratory standards prior to implementation of the program. It is also important to consider who performs inspections. To this end the CFAS advocates for inspectors who have been trained in the field of assisted reproduction, particularly as it pertains to all activities outside of the scope of the physician, namely the embryology and andrology labs. We highly recommend using trained fertility nurses and lab directors to participate in the inspection program, in addition to trained fertility specialists. The model of using experts within the field has worked well with Accreditation Canada and we advise the College to adopt a similar model in its inspection program. Prior to implementation of the new inspection program, there must be a process to educate clinics and to allow for feedback on the standards themselves.
CFAS and its multidisciplinary resources are well positioned to assist the College in its development of an inspection program. As an organization, we strive for excellence in the field of assisted reproduction and we feel strongly that the provincial licensing program can be an important part of this effort. However, if the inspection program remains solely focused on minimum safety standards, the College and the province will miss a prime opportunity to ensure Ontario – and Canada – remains at the forefront of quality care in assisted reproduction.
Through the voluntary efforts of Canadian fertility centres, physician leaders, lab scientists and other allied health professionals across the country, Canada has become among the best and safest places to receive fertility care. After all, it is in our collective best interest to ensure optimal quality and safety for patients. To maintain the high level of care, an inspection program must be able to adapt to rapid changes occurring in the field whether they be related to adoption of new technologies or potential public health crises, such as experienced in 2016 with the Zika virus. The CFAS can easily assist the College in adapting the inspection program to accommodate and account for change. We strongly encourage the College to use all available resources to develop a meaningful inspection and quality assurance program for fertility services in Ontario by engaging experts within the CFAS. Finally, we recommend the College re-examine the benefits of using standards developed by Accreditation Canada for assisted reproduction. The CFAS prefers the adoption of national standards, which already exist through Accreditation Canada.
Canadian Fertility and Andrology Society
On behalf of the CFAS Board of Directors
I believe the Canadian Fertility & Andrology Society would be better suited to accrediting fertility clinics, as the CPSO may not have the necessary experience or expertise in determining whether clinics are meeting the standards of complex fertility care.
College of Physicians and Surgeons of British ColumbiaResponse in PDF format.
I would first like to echo the sentiments of another physician who put it very clearly when, on Jan 11, they stated:
“We IVF providers respect our laboratory colleagues for an expertise that we do not expect to attain as physicians The CPSO can help physician fertility service providers by providing standards and best practices for medical services, but it is out of the scope of the CPSO to address laboratory quality.”
Additionally, I stand strongly behind the CFAS’s statement that “Standards must do more than ensure a minimum safety standard in the lab environment (infection control procedures, safety of medical devices), but serve to ensure quality output of the lab itself.”
I share in the concern of many of my colleagues that ensuring quality in embryology and andrology laboratories is beyond the scope and expertise of the CPSO.