Changing the Roles – Change Theory and PAMS (Week 10)

In the last 80+ years, the role of families surrounding infant feeding have been systematically changed as a result of urbanized populations, specialized medical practice, and commercialization (profitized) infant feeding. In the last 5 years, there has been unprecedented support for breastfeeding from all levels of government, professional organizations, consumer rights groups, and from parents themselves. This change is auspicious as background making PAMS growth and establishment possible, driven almost exclusively by participants as consumers and change agents. This change in the way that breastfeeding and the provision of human milk are seen throughout the socio-political spectrum provides some interesting observations and poses some unique challenges. I have the pleasure again this week of including observations and considerations from Elizabeth Brooks JD, IBCLC, FILCA.

Lewin’s Theory of Change

Kurt Lewin Change Model. Graphic from Alchemy for Managers

Kurt Lewin Change Model. Graphic from Alchemy for Managers

Lewin proposes that everything exists in a field of opposing forces. In the case of PAMS-

Driving Forces – Consumers of healthcare policy and professional guidance, i.e. infant families choosing to participate in milk sharing by private arrangement. Milksharing networks and advocates are also driving forces, however, within the context of policy entrepreneurship the personal interest of networks must be taken into consideration in addition to the value of contributions to change supporting consumer demands (Kingdon, 2010).

Opposing Forces – Profit seeking entities (milk cooperatives and for-profit milk banks), the the Human Milk Banking Association of North America, United States Food and Drug Administration, and individual healthcare providers are just a few of the major opposing forces of PAMS. Self interests must again be considered. Lack of knowledge and consideration of the practice not only on merit of the practice of PAMS, but as a result of marginalization of the personally identified importance of agency and autonomy in infant feeding decisions contribute to these opposing forces (Kingdon, 2010; Akre et al., 2013).

Movement

Policy regarding PAMS is currently in the Movement phase of Lewin’s model. It is during this phase that the nature of change is defined, and the abilities of change agents challenged. The consumer driven infant feeding intervention of PAMS puts individual participants as consumers of healthcare in a difficult position at the curl of the wave of change. In speaking with Brooks about the unique aspects of  the consumer-turned-change-agent in individual decisions and more broad social change, it was made clear that there is no singular way of making change. “They [effective change agents] look like folks who can persuade decision-makers to come to the result the change agent seeks. In healthcare, the needs and wishes of the patient/client (“consumer”) are supposed to drive informed decision-making and care planning.”

Difficulty arises when this foundation of consumer driven healthcare and individualized evidence informed practice fail to be realized in reality. Participants have found themselves in precarious positions where they are expected to be consultants and educators to their healthcare providers regarding their decision to participate in PAMS. Media and even recent academic coverage of alternative sources of human milk have only raised the difficulty in navigating the movement and continuing to drive forces of change toward acceptance of PAMS as part of the infant feeding spectrum of choices.  According to Brooks,  “[T]he consumer is often the least empowered to see this happen. Any issue that the mainstream media or healthcare establishment perceives as “risky” will add extra layers of difficulty in getting to a well informed discussion and decision.” This, I believe, is the proverbial cue for research and academia to contribute in the way of evidence to bolster and clearly define merits and challenges of future policy development and change (Kindon, 2010).

Criteria for Survival

Per Kingdon, the primary criteria for survival of a new policy (Refreeze) is a test of public acceptance (2010). Considering the relatively minor number of families currently participating in PAMS, this test is likely going to be a long one. Government at all levels and agencies of the private and public sector are priding themselves on innovative solutions and meeting the needs of consumers, as the consumer defines those needs when and where evidence supports change (Liebman, 2013). Commitments have been made in adapting funding for research into initiatives, programs, innovations, and solutions originating in a variety of sources, and with scalable implications (Liebman, 2013). PAMS has demonstrated a moderate degree of scalability since its inception, and certainly fills a need expressed by consumers for a source of human milk that is immediately and realistically obtained. Support for the provision of human milk exists in policy, practice, and evidence in formalized contexts. The critical gap with PAMS in relation to Liebman’s position and exemplars regarding recognition and funding for viability is the current insufficient evidence regarding specific characteristics of the practice to evaluate efficacy in bridging a gap created by other complex inequities in access to support for lactation and provision of human milk.

Closing Thoughts

Progress is being made in defining the practice, resources, and realities of PAMS by myself and others in academia in many contexts related to PAMS. As these pieces come together, it is my sincere belief that a case will be made for PAMS as a viable option for families seeking to provide human milk in the absence of sufficient milk from a biological parent. Participants as consumers of healthcare and agents of change in PAMS health policy are likely to blaze their own trails in creating solutions to their individual infant feeding needs and beliefs. I applaud the commitment and dedication that it takes for donors and recipients alike to contribute so meaningfully to a practice that creates such an opportunity for dialogue regarding the role of policy and agency in healthcare.

References

Brooks, E. (2014). Personal Correspondence.

Kingdon. (2010). Agendas, Alternatives, and Public Policies, Update Edition (2nd ed.). London: Longman Publishing Group.

Liebman, J.B. (2013). Building on recent advances in evidence based policy making. Brookings. Washington, DC. Retrieved 3/2014 from http://www.brookings.edu/research/papers/2013/04/17-liebman-evidence-based-policy

 

 

 

 

 

 

Protecting PAMS Participants’ Privacy – Group Asks Participants to Share Private Information (Week 9)

Foundation of Privacy Rights Image

The establishment of protections for personally identifiable information security in healthcare and human subjects research through the Health Insurance Portability and Accountability Act (HIPAA) establishes rights of control, disclosure, and informed consent for the collection and use of said information for the person the information pertains to (United States Department of Health and Human Services [HHS], 2013). Protection of this information becomes increasingly more complicated when electronic records are involved, transmission or sharing of protected information occurs, or when the use of information is for purposes secondary to the collecting practitioner use in treatment (Schweitzer, 2011). Difficulty or complexity in maintaining the integrity of personally identifiable information is accepted as a challenge, however, sanctions against violation of rights concerning health and personal information exist and are a significant financial and criminal liability with additional liabilities potentially levied on a state by state basis (Schweitzer, 2011; Pritts, 2007). In order to ensure that every effort is made to protect both the subject of the information and the organization or researcher collecting the information for use in research or providing care, Institutional Review Boards Human Subjects Committees (IRBs) and specific requirements for Risk Analysis and Management within all health organizations, programs, and clinics (Nass et al., 2009).

How is PAMS affected?

Private Arrangement Milk Sharing (PAMS) is a complex practice. Part of that complexity arises from the frequent nature of the agreements being “Contract Implied in Fact” arrangements involving individually identifiable information and/or the exchange of health information. A Contract Implied in Fact “Consists of obligations arising from a mutual agreement and intent to promise where the agreement and promise have not been expressed in words. Such contracts are implied from facts and circumstances showing a mutual intent to contract, and may arise by the conduct of the parties. A contract implied in fact is a true contract” and is entered into upon exchange of milk in a PAMS relationship. The exchange of milk in PAMS fulfills requirements of conduct illustrating “an unambiguous offer, unambiguous acceptance, mutual intent to be bound, and consideration.” A critical part of this contract obligation is the use of the donated milk and information regarding health and lifestyle of the donor obtained during screening be used for the purpose of providing for the recipient infant/family and that infant/family alone, and this is supported by the claims of each of the major PAMS networks.

All of the major milksharing networks make clear their stance to be uninvolved in the specific between party agreements involved in PAMS including questionnaires and screening tools (Eats On Feets), asserting that all individuals take complete responsibility for outcomes of milksharing as individuals (Human Milk 4 Human Babies). This explicit maintenance of non-participation ensures that as networks, they are not included in provisions requiring adherence to HIPAA. These organizations provide description of their belief that information collected for research or analysis should not be undertaken by the networks, presumably for both philosophical and practical conflict of interest reasons. Encouragement to violate this foundation of expectation by soliciting third party information is counter productive to the specified intent and spirit of milk sharing as a private arrangement strictly between the donor and recipient, and undermines the security in providing information confidentially. So who is intentionally asking that this expectation and potentially contractual obligation to honor privacy in the PAMS agreement be violated?

MIDAS

The Milksharing Incident Database and Survey (MIDAS) is described on their website as “…a grassroots public health program created by World Milksharing Week.”* Neither the survey nor the incident reporting options provides an informed consent document, indication of data security, intended use, authority to collect such data, de-identification procedures, or information regarding data security and storage. There is no IRB approval for any of the actions undertaken by this organization. In the frequently asked questions tab of the website, it is stated that there is absolutely no follow up on any information provided, and that all information is provided anonymously. On the same page, follow up is discussed as occurring in “severe and very severe” instances, with a medical professional that MIDAS chooses. No information is provided regarding vetting of medical professionals, authority for them to contact respondents, and certainly not to contact individuals who’s personal information was obtained through a third party without consent. So, if the reporting is anonymous, how does the follow up occur? The answer is likely that this website is an integrated WordPress account, as it is hosted by Bluehost, and WordPress has the capability of tracking the IP addresses of users who interact with websites. Not particularly anonymous, or secure.

Necessity?

No evidence or foundation based on the current level of knowledge concerning PAMS is provided by the creators of MIDAS. The efforts are redundant, as my own research and that of several other teams operating in the US and Canada are collecting practice information and participant beliefs. These research endeavors are being conducted under approved IRB circumstances, and with full disclosure to all participants. Considering this information is being collected in such a way that it cannot be used for legitimate research, it is likely that such a site poses more harmful potential than benefit for any efforts to generate policy and evidence regarding PAMS.

Closing Thoughts

The PAMS community and participants are operating under very biased and intensive scrutiny from existing health authorities. Concerns about the cavalier attitude of those participating and the presumed ignorance of those involved is frequently discussed. A site clearly not manned by an experienced researcher or data manager, seeking information from third parties without any right to do so and potentially in violation of individual state and federal regulations regarding protected information and contract law, and without recourse for those who may be seriously wronged in this process certainly does not refute these views of PAMS. It is deeply disturbing to me, personally, to see otherwise well respected researchers who would certainly be expected to understand their inability to be associated with such an undertaking per their involvement with research institutions already are being named as partners in this endeavor through World Milksharing Week.

* The milksharing network Human Milk 4 Human Babies and Modern Milksharing are included in the committee responsible for the creation of MIDAS. This involvement and endorsement is in direct opposition to stated intentions to stay removed from involvement and to support individual accountability of participants on their networks and sites.

References

Nass, S. J., Levit, L. A., Gostin, L. O. (2009). Beyond the HIPAA privacy rule: Enhancing privacy, improving health through research. Washington, D.C: National Academies Press.

Pritts, J.L. (2007) Federal efforts to impose uniformity on state healthcare laws. Health Law and Policy. Vol. 20 (2). Pp 20-23.

Schweitzer, E. J. (2012). Reconciliation of the cloud computing model with US federal electronic health record regulations. Journal of the American Medical Informatics Association : JAMIA, 19(2), 161-165. doi:10.1136/amiajnl-2011-000162

Advancing Policy from the Private Sector (Week 8)

Why Private Sector?

With respect to PAMS, the advancement of legislative policy is not likely to be desired by those who choose to participate. When legislative efforts to support lactation fall short, or do not survive the policy process, and in light of the general mistrust and lack of understanding of the nuances of lactation, it isn’t any wonder. Where many involved with PAMS would like to see policy is at the level of the private sector professional organization, particularly those representing lactation consulting, lactation and human milk medical research and education, nursing, and obstetrics. Private organizations aligned with these specialties are uniquely positioned to support families in making informed decisions regarding specific practices associated with PAMS.

The realities of implementation of policy, no matter the source, are that private sector organizations have a significant role to play. Longest (2013) breaks the selection of an organization as the conduit for policy implementation into two steps (1) goals and objectives of the policy in question should find sympathy within the target organization and (2) the necessary resources (from authority to financial means) exist within the selected sympathetic organization. Due to the dedication of the American Academy of Nursing’s reputation, National driving of policy regarding breastfeeding in a professional and consultative role, and a significant commitment of time and resources to lactation and human milk policy, this organization fits well within the criteria established by Longest.

PAMS Policy Implications for Lactation Professionals

Lactation and by extension PAMS support frequently intersect with care providers wearing multiple hats while executing their practice and providing support. It is my great fortune and pleasure to have the opportunity to discuss intersection of private policies regarding lactation support and PAMS with Elizabeth Brooks, JD, IBCLC, FILCA. Brooks has been involved in policy making and implementation in leadership roles for the International Lactation Consultants Association (currently as President), as well as the United States Breastfeeding Counsel.

Most of the front-line, first contact lactation support persons are Internationally Board Certified Lactation Consultants (IBCLC), operating under the private guidelines for conduct and accreditation of the International Lactation Consultants Association (ILCA). Because many IBCLCs are also registered nurses frequently working within hospital systems, understanding the significance of policy from the American Academy of Nursing (AAN), the ultimate goal of the labors of this blog, on the practice of IBCLCs is important.

According to Brooks, “No IBCLC “needs” a policy to tell them how to work with clients or patients.  They have the International Board of Lactation Consultant Examiners (IBLCE) Code of Professional Conduct, IBLCE Scope of Practice , IBLCE Clinical Comptenices and ILCA Standards of Practice that are authoritative practice-guiding documents.  We can add in the International Code [for marketing breastmilk substitutes] if they are in a country where it is legislated, or works in a facility seeking to obtain/retain Baby Friendly designation.  If the practice or facility where an IBCLC works has a policy on any aspect of clinical care or decision-making [such as a policy from the AAN adopted by a facility], then the IBCLC will be bound by those “extra” practice-guiding documents that spring from conditions of employment.” Specific to IBCLCs in private practice faced with how to address PAMS, it is a matter of maintaining sensibilities surrounding liability of finance, legal, and professional natures. “Private practitioners — even solos — ought to have a policy and procedure manual guiding all aspects of their work as allied health care providers.”

Closing Thoughts

It is evident that IBCLCs, due to diverse practice settings, are likely to require tailored support for individual implementation of any polices regarding PAMS. Bearing this in mind, the recommendations entered into the policy development regarding PAMS have been selected and worded specifically to provide clarity of purpose and intention. This, it is sincerely hoped, will facilitate the adoption and dissemination of the policy even in light of the already existing complexity of IBCLC and RN practice.

References

Longest, B. B. (2010). Health policymaking in the United States (5th Ed.). Chicago, IL: Health Administration Press.

E. Brooks. Personal communication March 3, 2014.