- Email: [email protected]
Chapter 27 Quality assurance in reproductive technologies
Chapter 27 Quality assurance in reproductive technologies BACKGROUND The issue of quality assurance in medical care is not unique to ART. General statutes, state and community medical or hospital boards, and review by professional organizations, seek to provide adequate quality assurance in most instances of medical practice involving treatments for infertility. However, because of the degree of potential impact on individuals and society, the use of ART highlights the reasons why quality assurance is so important. Because of the sensitivity of reproductive decisions and the possibilities for abuse in this area, the importance of quality assurance in medical practice becomes especially evident with the use of ART. For the most part, infertile couples do not have life-threatening disorders; therefore, suboptimal medical treatment does not usually result in overt medical complications. Nevertheless, the emotional and financial costs resulting from this suboptimal care can be enormous. Patients may not be able to judge adequately the quality of a program. It would be possible for a clinic to have no successes without the patients ever realizing it. For example, with respect to IVF, the current average maximum pregnancy rate is below 30% per treatment cycle. Couples who failed to achieve pregnancy might believe that they were among the unlucky 70% and might not recognize that they had not received adequate service. In 1988, the first annual report from United States clinics participating in the IVF-ET Registry was published. The Registry was established by the Society for Assisted Reproductive Technology (SART), an affiliate of The American Fertility Society, and Medical Research International (MRI). The first report (MRI, 1988) presented summary data of the 1985 and 1986 practices and results from 41 U.S. clinics. The second annual report (MRI, 1989) presented results from 119 clinics, and the third annual report from 135 clinics (MRI, 1990). In the most recent report for 1991, 212 clinics reported on 24,671 stimulation cycles for IVF, 21,083 Vol. 62, No.5, November 1994
retrievals, 18,372 transfers, 4,017 clinical pregnancies, 223 ectopic pregnancies, and 3,215 live deliveries, including 965 multiple deliveries. Approximately three-fourths ofthe programs initiated < 100 cycles per year. The live birth rate with fresh preembryos for IVF was 15.2% deliveries per retrieval cycle (SART, 1993). It is not known how many of the nonresponding centers have established pregnancies. Clinics offering DI also vary substantially in their success rates and in the amount of time required to achieve a pregnancy. It is important that the profession undertake measures to enhance the quality of practitioners' skills and the quality of clinics, and to ensure that the public is provided with adequate information so that they can make responsible choices. Reproduction has long been addressed by religious and other traditions; it has been constrained by moral considerations and legal interpretations. It is not surprising that innovative reproductive technologies generate unusual public interest and concern. Consequently, special attention to quality assurance and ethical awareness is imperative to allay public concern. To wit, legislation has been enacted (1) that requires certification of embryo laboratories as well as public reporting of clinic success rates. Implementation is pending.
TRAINING In most ART, specialized training is necessary. For example, The American Fertility Society has, over the last few years, developed standards for the specific training and experience necessary to provide a minimum assurance of quality in an IVF program (Appendix D). Similarly, the American Association of Tissue Banks (1984) has specified the type of training that should be required for a person to serve as a director of a sperm bank. By following these models, the profession should continue to promote and expand similar standards for the training of all practitioners of reproductive techniques in a medical setting. Supplement 1
SIS
Consideration should be given to participation in hands-on training programs in ART. These should be in addition to regular postgraduate education seminars and should be specifically designed to enhance practitioners' skills. There should be procedures developed for continuing assessment of practitioners' skills. For example, separate methods of certification of persons and programs need to be established. Within this certification method, annual assessment of clinical outcome should be mandatory. One approach to accomplish this goal has been taken by SART, which requires its membership to meet certain standards of experience and training (Appendix F). A specific problem that has come to the attention of the Committee is that some new ART programs, such as the IVF clinics, are starting up without the public being informed that they lack adequate experience in these technologies. When a procedure is being done for the first time by a practitioner or for the first time at a particular facility, that procedure should be viewed as an experiment. The clinician should also disclose to the patients his or her level of experience with a particular procedure. In the start-up phase of the procedure, patients should not be charged the same amount as they would be in a clinic with a record of success, which indicates a high level of experience and expertise with the procedure. Indeed, there is merit to the position that charges should be reduced until the clinic has established a reasonable success rate. In fact, some existing programs waived their professional fees while they were in the start-up stage. OPERATIONS
The physician and staff should attempt to standardize the ongoing operations of the faculty. The clinic or practice should have standards for hiring and training personnel. It should employ informed consent forms and procedures, and a fee schedule for its services; these materials should be provided to patients on a routine basis. In the operation of the clinic or practice, it is important that donors (of sperm, oocytes, or preembryos) and surrogate mothers be screened for assurance that they do not pass on a genetic defect or an infectious disease. Screening should be done in compliance with the guidelines set forth in chapter 15 and in Appendices B and C. Specific guidelines have lieen developed under the Clinical Laboratory Improvement Act (CLIA) for monitoring the equipment and procedures so 828
Supplement 1
that quality is maintained. For example, there exist provisions for periodically having the liquid nitrogen tanks in a DI clinic and the incubation equipment in an IVF program checked. In IVF clinics, use of animal embryo quality controls is mandatory for testing the culture media and the toxicity of equipment and incubation systems. Each laboratory performing a specific function, such as cryopreservation, may have its own quality control standards. Therefore, it is important that the standardization of quality control be carried out along with the development of each technique. In this way, the expertise of those performing the procedure can be assured, the facilities can be standardized, and the extent of use of the technologies in patient care can be determined. FOLLOW-UP
An important tenet of medical practice is that practitioners be aware of the outcome of treatments that they prescribe, so that they can make better decisions in the future. Careful follow-up of patients-and particularly of offspring-is important for monitoring the impact of ART (Morin, 1989). Most of these technologies have come into use within the past 10 years, so resulting children have not been followed on a long-term basis. The Committee is concerned that even DI, which has been in widespread use for a much longer time, has not been studied sufficiently for its effects on the psychological well-being o{the couple, the donor, and the child conceived. Follow-up studies on the physical and psychological well-being of participants in ART are necessary. Even if physicians do not wish to engage in research, they should follow their patients in a way that enables them to make better use of these treatments in the future, and they should keep records that can be used by others who are interested in research. To this end, SART was developed to provide a formal, independent data collection system to recover data from all centers in the group, to be analyzed and published annually. RECORD KEEPING
Physicians should keep confidential records on the patients who use ART. This record-keeping system should include a mechanism for later identification of donors and surrogates, so that if a child is born with a genetic defect or other problem resulting from a donor's sperm or oocyte, it would be Fertility and Sterility
possible to bar the donor from future use and discard any frozen gametes. Such records should be maintained in a confidential manner in accord with current state law. If records include research data, then a certificate of confidentiality should be obtained from the Public Health Service within the U.S. Department of Health and Human Services. Such records have not served as the basis for any type of paternity suit against a donor or surrogate. The reluctance of physicians to keep records in the past has been due to their unwillingness to expose donors to financial liability. Ifthe parties have knowingly donated gametes or preembryos and have agreed that the donor would have no rearing obligations, financial obligations are not likely to be imposed. Record keeping should extend beyond the clinical setting to include precise follow-up of all gametes or preembryos for research or other purposes. These records should be maintained by scientists in a fashion similar to clinical record keeping. In the effort to standardize record keeping, The American Fertility Society and other organizations continue to encourage the collection of compatible data on both a local and national basis.
DISCLOSURE TO PATIENTS
One of the most important mechanisms for quality assurance is providing patients with information that will help them judge the quality of the clinics. In the past, some practitioners may not have been entirely forthright in their presentation of information to patients (chapter 7). Patients should be informed of the guidelines for operation of standard practices. Clinics offering untried technologies should disclose this fact. Prospective patients should be fully aware of the risks and benefits of the proposed procedures, as well as given the pregnancy and abortion rates and the live birth rates of these procedures. Data should include the national averages and the rates of that particular practice or clinic. Patients should be informed of up-to-date success rates and feasibility of alternative procedures. They should be advised of other resources and support groups that can assist them during treatment for infertility. Couples should be told the cost of services, which are often not covered by health insurance. Patients should also be told of the nature of the organization offering the infertility services: whether it is part of an academic center, a private practice, a commercial organization, etc.
PROFESSIONAL DISCLOSURE
COMMITTEE RECOMMENDATIONS
Data on ART should be collected and disseminated so that professionals can better understand the technologies and how to use them. Currently, many IVF practitioners publish their results in the medical literature so that other professionals in the field can assess the safest and most efficacious ways to perform these procedures. However, physicians involved with surrogate motherhood, which has been controversial and not widely accepted, have not published their data in scientific journals. Thus, it is difficult to know the success rate in that area and develop quality approaches to attempting surrogacy. When data are collected on a regional or national basis, statistics should be published in the professional journals. For each technology, there should be published the number of retrievals, the number of resulting pregnancies, the health status of the child, and any follow-up information. As an example, the data collected from SART are summarized annually in Fertility and Sterility. Similar approaches should be taken for the other technologies such as DI and surrogacy.
The Committee recommends that The American Fertility Society, in conjunction with other public and professional groups, continue to take the initiative in encouraging professional and public oversight of ongoing reproductive technologies. Moreover, the Committee recommends that before a practitioner or clinic first offers a service, that practitioner or clinic submit the procedure to an Institutional Review Board and/or other ethical boards that can render an opinion on whether the procedure will be offered in an appropriate manner and whether the informed consent procedure is properly in place. As the practitioner or clinic gains experience, this experience should be reported periodically to the Institutional Review Board until such time as the Board determines that continuing review is ·no longer needed. The American Fertility Society has provided professional organizations with the design of a minimum dataset to serve as a guideline for physicians and other professionals concerning the types of clinical records they should keep. In the use of this minimum dataset, attention should be given to
Vol. 62, No.5, November 1994
Supplement 1
838
establishing standard terms regarding what an attempt is, what a pregnancy is, etc. SART has made substantial progress in data collection and reporting. In addition, laboratory accreditation and licensing has improved quality control in culture methods. These trends should be expanded. Failure to adhere to such standards is deemed ethically unacceptable. The Committee recommends that individual practitioners and clinics prepare annual reports, the most recent of which will be available to patients and other interested persons. This report should include the number of attempts at the various reproductive procedures, pregnancy and spontaneous abortion rates, and live birth rates, reported in a uniform manner as indicated above, and any follow-up information, such as problems that may occur. With an area as central to their lives as
848
Supplement 1
reproductive technology, people should make decisions about whether or not to use a given technique -and practitioners should make decisions about offering it-only on the basis of the most thorough and reliable information possible. Many procedures have recently been developed which have demonstrated usefulness (e.g., microtechniques and surrogate gestational motherhood). Although short-term efficacy may have been proved, the Committee is concerned about longterm effects of these procedures. The Committee therefore recommends that the physician should encourage and participate in long-term follow-up of the offspring and other parties involved. REFERENCE 1. Pub Law 102.493 (HR 4773) 24 Oct 1992
Fertility and Sterility
retrievals, 18,372 transfers, 4,017 clinical pregnancies, 223 ectopic pregnancies, and 3,215 live deliveries, including 965 multiple deliveries. Approximately three-fourths ofthe programs initiated < 100 cycles per year. The live birth rate with fresh preembryos for IVF was 15.2% deliveries per retrieval cycle (SART, 1993). It is not known how many of the nonresponding centers have established pregnancies. Clinics offering DI also vary substantially in their success rates and in the amount of time required to achieve a pregnancy. It is important that the profession undertake measures to enhance the quality of practitioners' skills and the quality of clinics, and to ensure that the public is provided with adequate information so that they can make responsible choices. Reproduction has long been addressed by religious and other traditions; it has been constrained by moral considerations and legal interpretations. It is not surprising that innovative reproductive technologies generate unusual public interest and concern. Consequently, special attention to quality assurance and ethical awareness is imperative to allay public concern. To wit, legislation has been enacted (1) that requires certification of embryo laboratories as well as public reporting of clinic success rates. Implementation is pending.
TRAINING In most ART, specialized training is necessary. For example, The American Fertility Society has, over the last few years, developed standards for the specific training and experience necessary to provide a minimum assurance of quality in an IVF program (Appendix D). Similarly, the American Association of Tissue Banks (1984) has specified the type of training that should be required for a person to serve as a director of a sperm bank. By following these models, the profession should continue to promote and expand similar standards for the training of all practitioners of reproductive techniques in a medical setting. Supplement 1
SIS
Consideration should be given to participation in hands-on training programs in ART. These should be in addition to regular postgraduate education seminars and should be specifically designed to enhance practitioners' skills. There should be procedures developed for continuing assessment of practitioners' skills. For example, separate methods of certification of persons and programs need to be established. Within this certification method, annual assessment of clinical outcome should be mandatory. One approach to accomplish this goal has been taken by SART, which requires its membership to meet certain standards of experience and training (Appendix F). A specific problem that has come to the attention of the Committee is that some new ART programs, such as the IVF clinics, are starting up without the public being informed that they lack adequate experience in these technologies. When a procedure is being done for the first time by a practitioner or for the first time at a particular facility, that procedure should be viewed as an experiment. The clinician should also disclose to the patients his or her level of experience with a particular procedure. In the start-up phase of the procedure, patients should not be charged the same amount as they would be in a clinic with a record of success, which indicates a high level of experience and expertise with the procedure. Indeed, there is merit to the position that charges should be reduced until the clinic has established a reasonable success rate. In fact, some existing programs waived their professional fees while they were in the start-up stage. OPERATIONS
The physician and staff should attempt to standardize the ongoing operations of the faculty. The clinic or practice should have standards for hiring and training personnel. It should employ informed consent forms and procedures, and a fee schedule for its services; these materials should be provided to patients on a routine basis. In the operation of the clinic or practice, it is important that donors (of sperm, oocytes, or preembryos) and surrogate mothers be screened for assurance that they do not pass on a genetic defect or an infectious disease. Screening should be done in compliance with the guidelines set forth in chapter 15 and in Appendices B and C. Specific guidelines have lieen developed under the Clinical Laboratory Improvement Act (CLIA) for monitoring the equipment and procedures so 828
Supplement 1
that quality is maintained. For example, there exist provisions for periodically having the liquid nitrogen tanks in a DI clinic and the incubation equipment in an IVF program checked. In IVF clinics, use of animal embryo quality controls is mandatory for testing the culture media and the toxicity of equipment and incubation systems. Each laboratory performing a specific function, such as cryopreservation, may have its own quality control standards. Therefore, it is important that the standardization of quality control be carried out along with the development of each technique. In this way, the expertise of those performing the procedure can be assured, the facilities can be standardized, and the extent of use of the technologies in patient care can be determined. FOLLOW-UP
An important tenet of medical practice is that practitioners be aware of the outcome of treatments that they prescribe, so that they can make better decisions in the future. Careful follow-up of patients-and particularly of offspring-is important for monitoring the impact of ART (Morin, 1989). Most of these technologies have come into use within the past 10 years, so resulting children have not been followed on a long-term basis. The Committee is concerned that even DI, which has been in widespread use for a much longer time, has not been studied sufficiently for its effects on the psychological well-being o{the couple, the donor, and the child conceived. Follow-up studies on the physical and psychological well-being of participants in ART are necessary. Even if physicians do not wish to engage in research, they should follow their patients in a way that enables them to make better use of these treatments in the future, and they should keep records that can be used by others who are interested in research. To this end, SART was developed to provide a formal, independent data collection system to recover data from all centers in the group, to be analyzed and published annually. RECORD KEEPING
Physicians should keep confidential records on the patients who use ART. This record-keeping system should include a mechanism for later identification of donors and surrogates, so that if a child is born with a genetic defect or other problem resulting from a donor's sperm or oocyte, it would be Fertility and Sterility
possible to bar the donor from future use and discard any frozen gametes. Such records should be maintained in a confidential manner in accord with current state law. If records include research data, then a certificate of confidentiality should be obtained from the Public Health Service within the U.S. Department of Health and Human Services. Such records have not served as the basis for any type of paternity suit against a donor or surrogate. The reluctance of physicians to keep records in the past has been due to their unwillingness to expose donors to financial liability. Ifthe parties have knowingly donated gametes or preembryos and have agreed that the donor would have no rearing obligations, financial obligations are not likely to be imposed. Record keeping should extend beyond the clinical setting to include precise follow-up of all gametes or preembryos for research or other purposes. These records should be maintained by scientists in a fashion similar to clinical record keeping. In the effort to standardize record keeping, The American Fertility Society and other organizations continue to encourage the collection of compatible data on both a local and national basis.
DISCLOSURE TO PATIENTS
One of the most important mechanisms for quality assurance is providing patients with information that will help them judge the quality of the clinics. In the past, some practitioners may not have been entirely forthright in their presentation of information to patients (chapter 7). Patients should be informed of the guidelines for operation of standard practices. Clinics offering untried technologies should disclose this fact. Prospective patients should be fully aware of the risks and benefits of the proposed procedures, as well as given the pregnancy and abortion rates and the live birth rates of these procedures. Data should include the national averages and the rates of that particular practice or clinic. Patients should be informed of up-to-date success rates and feasibility of alternative procedures. They should be advised of other resources and support groups that can assist them during treatment for infertility. Couples should be told the cost of services, which are often not covered by health insurance. Patients should also be told of the nature of the organization offering the infertility services: whether it is part of an academic center, a private practice, a commercial organization, etc.
PROFESSIONAL DISCLOSURE
COMMITTEE RECOMMENDATIONS
Data on ART should be collected and disseminated so that professionals can better understand the technologies and how to use them. Currently, many IVF practitioners publish their results in the medical literature so that other professionals in the field can assess the safest and most efficacious ways to perform these procedures. However, physicians involved with surrogate motherhood, which has been controversial and not widely accepted, have not published their data in scientific journals. Thus, it is difficult to know the success rate in that area and develop quality approaches to attempting surrogacy. When data are collected on a regional or national basis, statistics should be published in the professional journals. For each technology, there should be published the number of retrievals, the number of resulting pregnancies, the health status of the child, and any follow-up information. As an example, the data collected from SART are summarized annually in Fertility and Sterility. Similar approaches should be taken for the other technologies such as DI and surrogacy.
The Committee recommends that The American Fertility Society, in conjunction with other public and professional groups, continue to take the initiative in encouraging professional and public oversight of ongoing reproductive technologies. Moreover, the Committee recommends that before a practitioner or clinic first offers a service, that practitioner or clinic submit the procedure to an Institutional Review Board and/or other ethical boards that can render an opinion on whether the procedure will be offered in an appropriate manner and whether the informed consent procedure is properly in place. As the practitioner or clinic gains experience, this experience should be reported periodically to the Institutional Review Board until such time as the Board determines that continuing review is ·no longer needed. The American Fertility Society has provided professional organizations with the design of a minimum dataset to serve as a guideline for physicians and other professionals concerning the types of clinical records they should keep. In the use of this minimum dataset, attention should be given to
Vol. 62, No.5, November 1994
Supplement 1
838
establishing standard terms regarding what an attempt is, what a pregnancy is, etc. SART has made substantial progress in data collection and reporting. In addition, laboratory accreditation and licensing has improved quality control in culture methods. These trends should be expanded. Failure to adhere to such standards is deemed ethically unacceptable. The Committee recommends that individual practitioners and clinics prepare annual reports, the most recent of which will be available to patients and other interested persons. This report should include the number of attempts at the various reproductive procedures, pregnancy and spontaneous abortion rates, and live birth rates, reported in a uniform manner as indicated above, and any follow-up information, such as problems that may occur. With an area as central to their lives as
848
Supplement 1
reproductive technology, people should make decisions about whether or not to use a given technique -and practitioners should make decisions about offering it-only on the basis of the most thorough and reliable information possible. Many procedures have recently been developed which have demonstrated usefulness (e.g., microtechniques and surrogate gestational motherhood). Although short-term efficacy may have been proved, the Committee is concerned about longterm effects of these procedures. The Committee therefore recommends that the physician should encourage and participate in long-term follow-up of the offspring and other parties involved. REFERENCE 1. Pub Law 102.493 (HR 4773) 24 Oct 1992
Fertility and Sterility