Administrative and Hospital-wide Services, Emergency Department, and

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1 HEALTH HEALTH SYSTEMS BRANCH HEALTH FACILITES EVALUATION AND LICENSING DIVISION OFFICE OF CERTIFICATE OF NEED AND HEALTHCARE FACILITY LICENSURE Administrative and Hospital-wide Services, Emergency Department, and Obstetrics in Hospital Licensing Standards Adopted Amendments: N.J.A.C. 8:43G-5.5, 12.2, 12.4, 19.1, 19.2, 19.3, 19.12, 19.14, 19.15, 19.30, 19.31, 19.34, and 36.3 Adopted New Rule: N.J.A.C. 8:43G-19.9 Proposed: February 4, 2013 at 45 N.J.R. 194(a). Adopted: by Mary E. O Dowd, MPH, Commissioner, Department of Health (with the Approval of the Health Care Administration Board). Filed:, 2013 as R d., without change. Authority: N.J.S.A. 26:2H-1 et seq., specifically N.J.S.A. 26:2H-5. Effective Date:, Expiration Date:. Summary of Public Comments and Agency Responses: The New Jersey Department of Health (Department) received written comments from a total of 35 commenters during the 60-day public comment period, which ended on April 5, Comments were received from the following individuals: The official version of any departmental rulemaking activity (notices of proposal or adoption) are published in the New Jersey Register or New Jersey Administrative Code. Should there be any discrepancies between this document and the official version of the proposal or adoption, the official version will govern.

2 1. Fran Gallagher, MEd, and Lori Feldman-Winter, MD, MPH, FAAP, Coordinating Partners, ShapingNJ Healthcare Workgroup, The State Partnership for Nutrition, Physical Activity and Obesity Prevention; 2. Rochelle Evans, Chair, New Jersey Women Infants and Children (WIC) Advisory Council; 3. Susan Mayer, BS, IBCLC, Chairperson, Monmouth/Ocean Breastfeeding Consortium, Belford, NJ; 4. Margaret M. Sheridan, RN, BSN, IBCLC, RLC, Westfield, NJ; 5. Alicia Dermer, Freehold, NJ; 6. Alison Farish, Fort Lee, NJ; 7. Arielle Cheifetz, Teaneck, NJ; 8. Brenda Braun, Ocean City, NJ; 9. Catherine Jones, Vineland, NJ; 10. Cecelia Bejar, Hoboken, NJ; 11. Cornelia Mazzan, Co-leader, New Jersey BirthNetwork, Fair Haven, NJ; 12. Diana Mayer, Freehold, NJ; 13. Diane Procaccini, Pennington, NJ; 14. Elaine Petrowski, Tender Times Postpartum Doula, Bloomingdale, NJ; 15. Elizabeth Otremsky, Collingswood, NJ; 16. Ellen Maughan, New Jersey Breastfeeding Coalition, Highland Park, NJ; 17. Jill Wodnick, New Jersey Maternity Care, Montclair, NJ; 18. Joslyn Crowe, Jersey City, NJ; 2

3 19. Mardi Mountford, MPH, Executive Vice President, International Formula Council, Atlanta, GA; 20. Marijane Lundt, Co-Executive Director, Partnership for Maternal and Child Health of Northern New Jersey, Newark, NJ; 21. Marilyn Hines, Lactation Consultant, IBCLC, MA, Millburn, NJ; 22. Mary Lou Moramarco, IBCLC, Holmdel, NJ; 23. Mary Turbek, Point Pleasant, NJ; 24. Melody Cason, Bellevue, WA; 25. Rebecca Wolfe, Meridian Health, Neptune, NJ; 26. Robyn D Oria, Central Jersey Family Health Consortium, Inc., North Brunswick, NJ; 27. Rose St. Fleur, Neptune, NJ; 28. Samantha Gordano, Cliffwood Beach, NJ; 29. Sarah Chaikin, Southern New Jersey Perinatal Cooperative, Pennsauken, NJ; 30. Sharon Mass, American Congress of Obstetricians and Gynecologists, New Jersey Section, Randolph, NJ; 31. Sherry Nemerofsky, Palm Beach Gardens, FL; 32. Stacy Gregg, New Jersey Maternity Care, Wharton, NJ; 33. Suzanne Bonamo, CLC, Florham Park, NJ; 34. Taryn Edwards, MSN, CRNP, NNP-BC, President, Delaware Valley Association of Neonatal Nurses, Philadelphia, PA; 35. Margaret Stedman, Haddonfield, NJ. 3

4 The number in parenthesis that follows each comment identifies the respective commenter listed above. General Support COMMENT 1: A commenter expresses strong support for the proposed amendments, which will provide consistency with national and statewide standards to support breastfeeding as well as provide evidence-based care for childbearing families. The commenter also applaud[s] the efforts of the [Department] to update regulations so that NJ hospitals can adopt policies and practices that afford optimal health outcomes for mothers and infants. (1) COMMENT 2: A commenter fully supports and endorses the proposed amendments... that would require changes in specific hospital operations to support breastfeeding at the time of birth and at the point of care of a breastfeeding mother or child receiving certain health care services offered under the hospital s license. The commenter believes the proposed amendments to the hospital regulations will provide a framework for hospitals to play a key role in promoting healthy lifestyle practices while respecting maternal choice for our NJ mothers and families. (2) COMMENT 3: A commenter fully supports the new proposed amendments... that would require hospitals to have written policies and procedures and mandatory staff training that will promote, support and protect breastfeeding. The commenter also congratulate[s] New Jersey for taking the lead in adopting proposals that protect mothers and babies in our state. (3) 4

5 COMMENT 4: A commenter urges adoption of the proposal, stating, The new proposal would insure both evidence based practice [and] support to the breastfeeding families throughout the state. (4) COMMENT 5: A commenter applaud[s] the proposed amendments and views them as a positive move towards improving hospital practices using evidence-based practices supportive of breastfeeding. The commenter favors the proposal s inclusion of the Joint Commission Perinatal Care Core Measures on Exclusive Breastmilk Feeding (8:43G-19.2, step 9),... staff training (8:43G-19.3, step (d)) and the use of evidence-based, non-commercial training materials (8:43G-19.3, step 1) to promote and support breastfeeding in the hospital. The commenter appreciates that the proposed amendments are respectful of mothers personal choices in infant feeding,... [which] will be helpful to all mothers and babies in New Jersey... and urge[s] the Commissioner... to adopt [the proposal]. (5) COMMENT 6: A commenter applaud[s] the Department s efforts to improve breastfeeding and maternal care in New Jersey hospitals. The commenter notes, [T]he pendulum has swung so far to the right on exclusive breastfeeding... New Jersey is clearly taking a balanced approach to newborn care [and] infant feeding. The commenter believes it is important to assist new mothers with breastfeeding, as the benefits to children are extensive, so long as this approach includes mothers who cannot or do not want to breastfeed exclusively. The commenter supports the amendment, which, regardless of the chosen feeding method, requires hospitals to perform infant feeding evaluations/follow-up assessments and interdisciplinary comprehensive treatment plans that address the recommendations for improvements in 5

6 infant feeding practices. The commenter expressed her support of the proposed amendment, which equally provides for infants who are breastfed, formula fed, and who are given formula supplementation. The commenter provides, This openness to multiple feeding methods shows that NJ is on the forefront of increasing breast-feeding rates statewide without sacrificing the confidence or capability of its new mothers to make the best decisions for their own families. (6) COMMENT 7: A commenter states, I fully support any amendments geared towards incentivizing or requiring that hospitals become more inclined to support breastfeeding. (7) COMMENT 8: A commenter states, This would be a big step in the reduction of obesity, Bravo, NJ!! (8) COMMENT 9: A commenter supports evidence-based maternity care practices in hospitals that significantly impact breastfeeding initiation and duration[.] I wholeheartedly and without hesitation endorse the proposed revision in the hospital licensing regulations... The commenter further states, I look forward to the next 20 years when New Jersey will stand out as a state that concretely addressed the childhood obesity problem, the juvenile diabetes problem and many other health problems that are impacted by the practice of breastfeeding in infancy. (9) COMMENT 10: A commenter commend[s] the Department s efforts to improve breastfeeding and maternal care within its hospitals. The commenter, who states she has the option to deliver her children in New Jersey or Manhattan, is concerned about the New York City Health Department s increased restrictions on formula feeding. The commenter views these restrictions as demonstrating a lack of understanding of, and 6

7 respect for, parental choice. The commenter believes New Jersey is taking a more balanced approach to newborn care [and] infant feeding. (10) COMMENT 11: A commenter wholeheartedly supports and endorses the proposal, recognizing the hard work and negotiations [that] have gone into the development of these new regulations. The commenter states the adoption of the proposal will support maternal-child health in New Jersey. (11) COMMENT 12: A commenter expresses agreement with the proposal. (12) COMMENT 13: A commenter appreciates the Department s efforts to improve breastfeeding success in New Jersey. The commenter is particularly supportive of the amendments set forth at N.J.A.C. 8:43G-19.12, stating, Mandating that hospital staff who come in contact with the newborn/mother dyad receive evidence-based breastfeeding education and then prove competency will go a long way to improving the success rate for initiating and maintaining breastfeeding in New Jersey and improving the long-term health of NJ s children. (14) COMMENT 14: A commenter supports the proposed amendments. The commenter hopes that mandating hospitals to provide staff education and develop policies that continuously support breastfeeding will be beneficial. (15) COMMENT 15: A commenter enthusiastically endorses the proposed amendments to the Hospital Licensing Standards and strongly urges the Commissioner of the Department of Health to adopt them. The commenter states that the proposed amendments would update the chapter by incorporating current evidence-based practices in infant feeding and ensure that the state s maternity hospitals develop the necessary policies and practices to enable them to provide mothers the information and 7

8 assistance they need to exclusively breastfeed... Significantly, the amendments recognize the importance of staff training and demonstration of core competencies that will improve perinatal care and health outcomes for all mothers and babies. (16) COMMENT 16: Two commenters submitted identical statements noting the length of time required to develop the proposal, stating, The policy changes towards improving breastfeeding in NJ are supported in all sections in its entirety. NJ Maternity Care is SUPPORTIVE of N.J.A.C. 8:43G-19.12(d). (17 and 32) COMMENT 17: A commenter states, I applaud the State of NJ for taking a balanced approach to newborn care, infant feeding, and maternal care than recently evidenced in the state of New York. The commenter disagrees with New York s one size fits all approach and commends New Jersey for implementing policies to increase breastfeeding rates without ostracizing women who cannot or choose not to breastfeed. The commenter also supports the proposed amendments that leave the option open to supplementation and formula for those of us mothers who were not able to successfully breastfeed from the outset. Empowering mothers to do what is best for themselves and their families and teaching healthy and safe feeding practices whether breastfeeding or formula preparation supports mothers during those critical post-partum weeks. (18) COMMENT 18: A commenter agrees that breastfeeding is ideal and offers specific infant and maternal health benefits The commenter regards a mother s decision about how to feed her infant as a personal choice. Towards that end, the commenter commends the Department for supporting all mothers in their choice of method of infant feeding through the proposed amendments and addition of a new rule 8

9 to the State s Hospital Licensing Rule. The commenter notes the Department understands both sides of the infant feeding debate because the proposal honors the rights of breastfeeding and formula feeding mothers. The commenter agrees that more can be done to increase breastfeeding rates in hospitals and maintains that mothers need to be supported in whatever infant feeding decisions are made. Specifically, the commenter supports the provisions set forth at N.J.A.C. 8:43G-19.2, 19.3, 19.9, 19.14(b) and 19.14(c). (19) COMMENT 19: A commenter supports the proposed amendments and new rule without reservations and applaud[s] the Department s proactive regulations that promote breastfeeding through education, support, and community resources. The commenter states, Requiring hospitals to establish policies that encourage breastfeeding is consistent with the most recent evidence-based research that directly links the long-lasting health benefits that result from exclusive breastfeeding from birth to at least six months. (20) COMMENT 20: A commenter hopes that the new hospital regulations are approved. The commenter notes that the proposal would help hospitals achieve BFHI [World Health Organization (WHO)/United Nations Children s Fund (UNICEF) Baby Friendly Hospital Initiative (BFHI)] initiatives. (21) COMMENT 21: A commenter applaud[s] and wholeheartedly endorse[s] the proposal. The commenter considers the proposal long overdue and believes the amendments would ensure that NJ s hospitals provide evidence-based practices in infant feeding. (22) 9

10 COMMENT 22: A commenter applaud[s] the proposal s inclusion of formula feeding as an alternative to breastfeeding, especially the support HOW to formula feed. The commenter appreciates that the amendments acknowledge not every woman can, or wants to, breastfeed and in this country [a mother] should be able to formula feed if she wants to, no questions asked. The commenter states hospital staff failed to provide literature on formula feeding after her baby was born. Furthermore, the commenter describes feeling hospital staff looked down upon [her]... for even considering formula feeding her firstborn child. (24) COMMENT 23: A commenter states, We are pleased to see that the New Jersey Department of Health is developing regulations in support of breastfeeding initiatives. (25) COMMENT 24: A commenter support[s] and endorses the proposed breastfeeding regulations, specifically citing the amendments would provide a framework for birth hospital policy and procedure development. The commenter also recognized the proposal would allow flexibility for each hospital to individualize their written policies. (26) COMMENT 25: A commenter strongly supports the Department s proposal. The commenter notes recent research demonstrates increased breastfeeding rates associated with evidence-based lactation practices and decreased rates without such support. In addition, the commenter regards education in basic lactation management as a means to correcting hospital practices that significantly impede successful breastfeeding. Furthermore, the commenter believes changes in lactation practices are both necessary and attainable. (27) 10

11 COMMENT 26: A commenter thanks the Department for not going the New York route, stating the proposal was right to support women provide education and information not guilt, shame and rhetoric. A woman needs to make the correct choice for herself and her family. (28) COMMENT 27: A commenter enthusiastically supports the proposed amendments, and believes the amendments will improve health outcomes for new mothers and infants as well as help contain healthcare costs. The commenter characterizes the proposal as vital because the increased support to new mothers at a critical time in their infants lives will improve maternal and child health outcomes. The commenter agrees with the proposal s respect for a mother s choices with regard to infant feeding and believes the additional education and support will serve to help women to make informed decisions with confidence. The commenter also states that the proposal will have longer term health impacts such as a reduction in chronic disease related to obesity and may help contain health care costs. (29) COMMENT 28: A commenter commends the proposal requiring hospitals to implement policies that support breastfeeding. The American Congress of Obstetricians and Gynecologists strongly supports breastfeeding and calls upon its Fellows, other health care professionals caring for women and their infants, hospitals and employers to support women in choosing to breastfeed their infants. The commenter indicates it is critical that women make an informed choice in deciding what is best for them, their families and their babies. The commenter considers breastfeeding as the preferred method of infant feeding, noting, Practices that support breastfeeding in the immediate postpartum period, specifically hospital practices, can 11

12 have a significant impact on both the rates of initiation and continuation of exclusive breastfeeding, the gold standard. (30) COMMENT 29: A commenter stresses the importance of education in the amendments, stating, It is vital for emotional, mental and physical health for the mother and baby to be aware of options... and to have a plan of action. The commenter further states that the choice of feeding method is very personal, and it is key to have the support of the medical staff, pediatricians, and obstetricians in each situation. (31) COMMENT 30: A commenter strongly support[s] the proposed amendments... and urge[s] the Commissioner... to adopt them. The commenter believes successful breastfeeding relationships are influenced by a number of factors, including education from healthcare professionals, community and family support, and healthcare system practices. The commenter concludes there needs to be stronger laws in NJ that aim to educate and support nursing mothers and create a more healthful and accepting environment for all. (33) COMMENT 31: A commenter expresses full support of the proposed amendments and urges their serious consideration in light of our country s serious health epidemics, like childhood obesity. The commenter also notes the proposal is necessary to impact women and infant care in New Jersey. (34) COMMENT 32: A commenter states she is thrilled with the changes and wholly support[s] them. (35) RESPONSE TO COMMENTS 1-32: The Department acknowledges the commenters support of the proposal. Clarification 12

13 COMMENT 33: A commenter states, How compelling that New Jersey is leading the nation with legislation that supports evidence-based maternity care practices in hospitals... I... applaud the legislature for embracing the profound impact of breastfeeding on the health of individuals, our society, the economy and environment. (9) RESPONSE TO COMMENT 33: As explained in the Summary to the proposal, the Department notes this rulemaking represents agency-initiated changes, not those mandated by legislative action. (45 N.J.R. 194(a).) Lactation staff-to-patient ratios COMMENT 34: A commenter states at proposed N.J.A.C. 8:43G There needs to be a specific ratio of patients to lactation staff and recommends, 1 full time lactation consultant, or IBCLC, for every 800-1,000 deliveries. The smaller ratio is for hospitals that are a level 3 NICU and perinatal centers (this is directed by ILCA and AWHONN) [The Association of Women s Health, Obstetric and Neonatal Nurses]. (13) RESPONSE TO COMMENT 34: Regarding the needs for staffing ratios, the proposal would permit facilities to decide how to best allocate resources to effectively comply with the proposed amendments. Moreover, the commenter s recommendation for establishing lactation staff-to-patient ratios by regulation falls outside the scope of this rulemaking. Based on the foregoing, the Department will make no change on adoption in response to this comment. Impact of breastfeeding on childhood obesity and chronic illness COMMENT 35: The commenter does not support some of the information presented in the aim of the proposed rulemaking, specifically the potential 13

14 overstatement about the benefits of breastfeeding. Chronic conditions such as obesity are based on many factors and the risk is not solely dependent upon the presence or absence of exclusive breastfeeding. The commenter states, [A] recently published, large, cluster-randomized controlled trial found that improved duration and exclusivity of breastfeeding did not prevent childhood overweight or obesity. The commenter also refers to the AAP s concerns about the limitations of breastfeeding research. (19) RESPONSE TO COMMENT 35: The Department disagrees that the proposal overstated the impact of breastfeeding on chronic disease. While the commenter does not identify the trial to which she alludes, the Department is aware of similar findings published in a recent study conducted on an infant population in Belarus whose authors received support from the Nestle Nutrition Institute. JAMA. 2013;309(10): doi: /jama The Department does not disagree that many factors contribute to obesity and observes the considerable body of literature that reinforces the positive correlation between breastfeeding and reduced rates of obesity. Most notably, in its February 27, 2012 policy statement, Breastfeeding and the Use of Human Milk, the AAP acknowledged a host of influences may affect the outcome of obesity research. Ultimately, the AAP determined to maintain its position that breastfeeding during infancy relates to a significantly lower incidence of obesity later in life. Because rates of obesity are significantly lower in breastfed infants, national campaigns to prevent obesity begin with breastfeeding support. Although complex factors confound studies of obesity, there is a 15% to 30% reduction in adolescent and adult obesity rates if any breastfeeding occurred in 14

15 infancy compared with no breastfeeding. ( Accessed August 14, 2013.) For the foregoing reasons, the Department will make no change on adoption in response to this comment. Baby-Friendly Hospital Initiative COMMENT 36: A commenter states the proposed amendments should be consistent with the WHO/UNICEF s BFHI to support and encourage exclusive breastfeeding, the biological norm. Exclusive breastfeeding, combination feeding and formula feeding in this document are treated as equals; they are not. The commenter also states, Anything less than endorsing exclusive breastfeeding is abdicating the responsibility of the Department. Breastfeeding is the recognized way to promote health and maternal child bonding in infancy. It has been endorsed by all major health organizations as the recommended way to nourish a baby. The commenter recommends establishing in regulation the following BFHI: 1. No food or drink to be given to any breastfed baby unless there is a medical necessity; 2. No use of pacifiers because they interfere with normal breastfeeding; 3. No discharge packs with formula should be given because it is a tacit endorsement of formula feeding; 4. WHO breastfeeding training of hospital staff should be mandatory and not discretionary; and 5. Every maternity hospital should be required to hire IBCLCs, who should be regarded as the experts that they are. The commenter states that the Department has a responsibility to promote health and to create an environment in which a woman can successfully breastfeed her baby... and the proposed [amendments] do not go far 15

16 enough to accomplish these goals. The commenter calls for the Commissioner to make all New Jersey hospitals Baby Friendly. (23) Another commenter also advocates the State s endorsement of the WHO/UNICEF BFHI. (13) RESPONSE TO COMMENT 36: The Department strongly disagrees that the proposal fails to support and encourage exclusive breastfeeding. As the Department indicated in the Summary statement to the proposal, the overarching goal of the proposed amendments and new rule is to improve maternal-infant health outcomes by establishing healthy practices in a manner that respects maternal choice beginning in the hospital at the time of birth. (45 N.J.R. 194(a).) Working with a broad range of external stakeholders to develop this proposed rulemaking, the Department also noted in the proposal s Summary that the initiatives promoting the health benefits of exclusive breastfeeding developed by such entities as the WHO, U.S. Department of Health and Human Services, and United States Breastfeeding Commission informed the development of this rulemaking and represent a coordinated effort to assist the Department in achieving its stated goal. (Id.) Furthermore, the proposed amendments would enable New Jersey to become one of only four states, including New York, California and Massachusetts, to require hospitals to establish policies that support breastfeeding practices. The proposed amendments and new rule have received the support of the State s leading professionals in breastfeeding for representing innovation and leadership to improve exclusive breastfeeding rates. While the proposal provides minimum standards for licensing purposes, the Baby Friendly Hospital status conferred by the WHO/UNICEF is an aspirational designation that hospitals may seek voluntarily outside of the regulatory scheme. WHO/UNICEF s BFHI represents a global 16

17 effort to protect, promote and support optimal infant and young child feeding. Baby Friendly Hospital Initiative: Revised, Updated and Expanded for Integrated Care. Section 1. World Health Organization and UNICEF pp. p. 1. ( Accessed August 20, 2013.) Moreover, the proposed amendments would not restrict facilities from adopting BFHI at their election. Based on the foregoing, the Department will make no change on adoption in response to this comment. Assessment of breastfeeding mothers in hospital emergency departments COMMENT 37: A commenter questions whether hospitals should determine if women presenting to the Emergency Department (ED) are breastfeeding without consideration of relevance to clinical treatment is excessive Having to document on an issue when it is unrelated to the clinical reason for presenting in the ED is unnecessary. The commenter suggests, instead, that at proposed N.J.A.C. 8:43G- 12.2(j)1.i., [H]ospitals initiate ways to educate patients, when clinically related to the ED visit, about the support available for breastfeeding. (25) RESPONSE TO COMMENT 37: The Department disagrees that the proposed amendment at N.J.A.C. 8:43G-12.2(j)1.i. to determine whether a woman who presents for treatment at the emergency department is breastfeeding, is either excessive or unnecessary. Specifically, the Department considers this determination as essential in the clinical evaluation of a nursing mother and may have implications for treatment in the ED. The commenter s suggested alternative language would be sufficiently vague and overly broad as a standard for the regulated community that likely would impede 17

18 uniform application and enforcement. For the foregoing reasons, the Department will make no change on adoption in response to this comment. Evidenced-based source materials COMMENT 38: A commenter expresses concern about the exclusion of commercial materials because she believes there is very little information on the differences between formulas or how to prepare them differently. (10) COMMENT 39: A commenter states that there are differing uses, forms and characteristics of infant formulas and information describing different products is essential to ensuring proper nutrition and handling. For these important reasons, we disagree that obstetrics staff should not use information from the companies who manufacture the infant formula products. Each infant formula product has its own preparation instructions, thus generic instructions may not provide important product distinctions and this may negatively impact both product safety and infant health. The commenter also disagrees with using current, evidence-based source materials free of commercial interests for staff education and training as set forth at N.J.A.C. 8:43G- 19.3(d) because infant formula companies have provided breastfeeding support and educational materials to healthcare professionals and such materials are simply not available from other sources. (19) RESPONSE TO COMMENTS 38 AND 39: The proposed amendments would not prohibit or in any way restrict hospitals to use product label information for the preparation and use of distinct commercially prepared infant food products. Proposed N.J.A.C. 8:434G-19.3(d) does not contemplate using product labels as source materials for education and training. Therefore, the Department finds concerns about product 18

19 safety, infant health and lack of distinction among formula preparations to be unfounded. With respect to the availability of non-commercial source materials, the Department disagrees that proposed N.J.A.C. 8:43G-19.3(d) would limit information available for staff training. To the contrary, the Department finds an abundance of evidenced-based, commercial-free information on infant feeding methods that is readily available to health care professionals and the public at large. Such well-respected organizations as the New Jersey Department of Health, the American Academy of Pediatrics, The Joint Commission, the Children s Hospital of Philadelphia, the Mayo and Cleveland Clinics, among many others, offer a wealth of informative, commercial-free, readily available, evidence-based materials that cover the spectrum of infant care and feeding. Based on the foregoing, the Department will make no change on adoption in response to these comments. Training for physicians and other providers COMMENT 40: A commenter questions why the proposed amendments at N.J.A.C. 8:43G-19.3 fail to require hospitals to educate providers, specifically, MDs, DOs, NPs. A large portion of problems associated with unnecessary supplementation of newborns involves direct misinformation by providers to patients. There needs to be an ongoing education requirement for providers, [that is, three] hours initially, and then at least yearly to work in conjunction with hospital staff. (13) Another commenter suggests, Physicians should also be included along with the nursing staff and lactation specialists to educate and support the families. (31) RESPONSE TO COMMENT 40: With regard to the commenters recommendations to include training for physicians and other independent providers, 19

20 proposed N.J.A.C. 8:43G-19.3 would require hospitals to educate all obstetrics staff who provide breastfeeding care and consultation regardless of professional affiliation. The Department notes that the length of time for such training is outside the scope of the proposed rulemaking. The proposed amendments would enable hospitals to tailor training to the needs of their health care professionals. Moreover, existing licensing standards require hospitals to regularly self-identify problems in operations, so that facilities may customize their quality improvement activities to achieve desired patient outcomes without additional regulation. For the foregoing reasons, the Department will make no change on adoption in response to this comment. Formula supplementation COMMENT 41: A commenter states, with respect to the proposed amendment at N.J.A.C. 8:43G-19.14(b), Combination feeding from birth (unless medically necessary) is not a method of feeding that will support breastfeeding increase. Breastfeeding with formula supplementation implies that the supplement is necessary. (13) RESPONSE TO COMMENT 41: The Department included the language in the proposed amendment at N.J.A.C. 8:43G-19.14(b) because breastfeeding supplemented by formula is an option available to mothers, irrespective of whether it supports increased breastfeeding or whether it is medically necessary. As stated in the Summary to the proposal, the Department s overarching goal with this rulemaking is to support maternal choice. (45 N.J.R. 194(a).) Based on the foregoing, the Department will make no change on adoption in response to these comments. Hand expression or pumping of breast milk 20

21 COMMENT 42: A commenter expressed concern about the proposed four-hour time frame within which to teach or assist mothers with manual extraction of breast milk and considers proposed N.J.A.C. 8:43G to be inconsistent with the literature which states pumping should begin at no less than six hours. (13) RESPONSE TO COMMENT 42: The Department adopted the recommendation of its stakeholder group for proposed N.J.A.C. 8:43G-19.14(b)1., which would require hospitals to teach or assist a mother with manual extraction of breast milk within four hours of being separated from her infant or having experienced ineffective breastfeeding. The Department notes the commenter fails to provide the context in which this purported six hour time period exists or identify the literature that supports her position, which limits the Department s ability to respond accordingly. For the foregoing reasons, the Department will make no change on adoption in response to this comment. Federal Standards Statement There are no federal standards regarding the support of breastfeeding in general hospitals. Full text of the adoption follows. 21