PRINTER'S NO. 1126
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No.
1001
Session of
2019
INTRODUCED BY OBERLANDER, YOUNGBLOOD, TOEPEL, KINSEY,
SCHLOSSBERG, KAUFFMAN, SCHLEGEL CULVER, SIMMONS, OTTEN, SIMS,
HILL-EVANS, STRUZZI, T. DAVIS, MULLINS, MARKOSEK, TOOHIL,
FITZGERALD, ULLMAN, DONATUCCI, SNYDER AND DALEY,
MARCH 27, 2019
REFERRED TO COMMITTEE ON HEALTH, MARCH 27, 2019
AN ACT
Regulating milk banks that provide donor human milk in this
Commonwealth.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. Short title.
This act shall be known and may be cited as the Keystone
Mothers' Milk Bank Act.
Section 2. Legislative intent.
The General Assembly finds and declares as follows:
(1) A mother's own milk is the optimal nutrition for
newborn infants and is a public health goal for the delivery
of food to all infants.
(2) Medically vulnerable infants, including those born
prematurely, with low birth weights or with congenital or
acquired conditions, derive significant health benefits from
receiving human milk.
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(3) Necrotizing enterocolitis is a devastating
complication that may result in partial or complete
destruction of the intestinal lining and may lead to both
short-term and life-long health consequences, including
premature death. An all-human-milk diet can significantly
lower the risk of necrotizing enterocolitis in medically
vulnerable infants, including those born prematurely.
(4) Mothers of medically vulnerable babies often face
unique obstacles to producing enough milk for their babies.
When a mother's own milk is not available, donor human milk
can provide a lifesaving health benefit for high-risk infants
as a supplement or bridge when determined to be medically
necessary.
(5) The American Academy of Pediatrics is a strong and
vocal proponent of the use of donor human milk for medically
fragile newborns when provided through properly regulated
milk banks.
(6) Children with a wide range of congenital or acquired
conditions may benefit from the use of donor human milk as a
component of treatment for their medical conditions when
their mother's own milk is unavailable or cannot meet all of
their needs.
(7) The use of donor milk is safe when appropriate
measures are used to screen donors and collect, store and
process the milk for distribution through milk banks licensed
by the Department of Health.
(8) Banked donor milk is predominantly pasteurized to
inactivate pathogens, tested for chemicals or substances that
could be injurious to high-risk infants and frozen for
storage and shipping. Human milk donors are carefully
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medically screened and blood tested to ensure they are
healthy and that the milk is free from any infectious
diseases or substances that could be harmful to high-risk
infants.
(9) The Human Milk Banking Association of North America
is a professional association that establishes and maintains
current, rigorous guidelines for the operation of human milk
banks throughout North America.
Section 3. Definitions.
The following words and phrases when used in this act shall
have the meanings given to them in this section unless the
context clearly indicates otherwise:
"Act." This act and any rule or regulation adopted under
this act.
"American Academy of Pediatrics." An American professional
association of pediatricians that issues clinical guidelines
regarding the use of donor milk in the delivery of medically
necessary care to newborns and babies.
"Batch." A limited quantity or grouping of donor milk
sharing a common characteristic as further defined by the
department.
"Birth center." A freestanding health care facility for
childbirth where care is provided in the midwifery and wellness
model.
"Collection." The obtaining of donor milk from medically
screened donors by a milk bank licensed in this Commonwealth.
"Committee." The medical advisory committee established by a
milk bank in accordance with section 5(a).
"Department." The Department of Health of the Commonwealth.
"Dispensary." A center that has an agreement with a milk
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bank for the distribution of milk from the milk bank by
prescription.
"Distribution." The delivery of medically ordered or
prescribed donor milk to a licensed acute care hospital, birth
center, lactation center, pharmacy, dispensary or medically
approved outpatient facility by a milk bank licensed in this
Commonwealth.
"Donor." A lactating woman with an excess supply of human
milk who:
(1) voluntarily contributes milk to a milk bank after
being medically screened and approved for milk donation; and
(2) receives no remuneration for the donation of milk.
"Donor milk." Human milk derived from a medically screened
donor that is voluntarily donated to a milk bank and processed
for distribution.
"HMBANA." The Human Milk Banking Association of North
America.
"Lactation center." A center whose sole or main purpose is
to provide support for and education about breastfeeding.
"License." A license issued by the department under this
act.
"Licensed acute care hospital." A hospital that is licensed
by the department under the act of July 19, 1979 (P.L.130,
No.48), known as the Health Care Facilities Act, and is equipped
and staffed for the treatment of medical or surgical conditions,
or both, in the acute or chronic stages, on an inpatient basis
of 24 or more hours.
"Licensee." A milk bank that holds a valid license under
this act.
"Medically screened." The process of or relating to the
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process of evaluating prospective donors by a milk bank to
determine the acceptability of the donor milk based on the
donor's past medical history, medication use, current state of
health and indicated laboratory studies through a process as
approved by the department.
"Milk bank." An entity that collects donor milk from
medically screened human donors and distributes the donor milk
to medically fragile children other than the donor's own child
based on a health care provider's order or prescription, using
storage, processing and shipping methods required by the
department.
"Person." An individual, partnership, association,
corporation, institution, agency or other similar entity.
"Processing." The standards and techniques approved by the
department for inactivating pathogens in donor milk and ensuring
the safety of donor milk.
"Professional association." A professional association that
establishes and requires member compliance with satisfactory
guidelines for the operation of human milk banks as designated
by the department. The term includes HMBANA.
"Professional association guidelines." Guidelines issued by
a professional association that govern the operation of milk
banks belonging to the professional association.
"Satellite milk depot." An entity that has an ongoing
relationship with a licensed milk bank to collect and store
donor milk for shipping to the licensed milk bank.
"Secretary." The Secretary of Health of the Commonwealth.
"Storage." The method of holding and freezing donor milk
approved by the department in connection with the donor milk's
collection or processing prior to the distribution.
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Section 4. Milk banks.
(a) Licensure.--An entity operating or seeking to operate as
a milk bank in this Commonwealth must apply to and be licensed
by the department.
(b) Application.--The department shall issue a license to an
applicant if:
(1) The applicant is in compliance with this act and has
submitted a completed application as developed by the
department that includes all the information required in
section 7.
(2) The entity meets one of the following requirements:
(i) Is certified as a member in good standing of
HMBANA.
(ii) Is certified as a member in good standing of a
nationally recognized professional organization for the
operation of milk banks.
(iii) Is determined to be in compliance with the
requirements of this act.
(c) Initial inspection.--Prior to the issuance of a license,
the department shall perform an inspection in accordance with
section 7(e).
(d) Denial.--
(1) An application that has not been approved within six
months of the date of the application shall be deemed denied.
(2) If the department denies an application, or the
application is deemed denied, the department shall provide
the applicant with a written explanation of the reason for
the denial.
(3) An applicant which is denied is entitled to a
hearing if the applicant requests a hearing within 30 days of
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the receipt of the denial or within 30 days of the deemed
denial if no written explanation is received.
(e) Fee.--The department shall charge the following fees for
the administration and implementation of this act:
(1) An entity shall pay a $1,000 fee for an initial
license.
(2) A licensee shall pay a $250 fee for each license
renewal.
(f) Expiration.--A license issued under this act shall
expire two years after the date of the issuance of the license.
(g) Renewal.--A license issued under this act may be renewed
in accordance with the regulations promulgated by the department
and upon the payment of a renewal fee.
(h) Suspension and revocation.--
(1) The department may suspend or revoke a license
issued under this act if the department determines that, in
accordance with section 7, the licensee is not in compliance
with this act.
(2) Written notification and a hearing shall be provided
in accordance with section 7(h) prior to the suspension or
revocation.
(i) Operation prior to effective date.--A milk bank in
operation prior to the effective date of this section may
continue to operate pending a decision on its application if an
application is made within 120 days of the later of the
following:
(1) The effective date of this section.
(2) The date that an application for a license is first
made available to prospective licensees under this act.
Section 5. Operation of milk bank.
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(a) Licensee requirements.--
(1) Each milk bank shall develop and ensure the
implementation of policies and procedures consistent with
professional association guidelines or the requirements of
this act.
(2) Each milk bank shall be operated by a managing
director responsible for the day-to-day operations of the
milk bank.
(3) A milk bank shall establish a medical advisory
committee to consult on milk bank operations, which shall be
composed of physicians and other allied health personnel with
experience in neonatology, blood or tissue banking, nutrition
and other related expertise. At least one member of the
committee must have experience in the field of infectious
diseases or biologics manufacturing.
(4) A milk bank shall have a medical director who is a
licensed physician with a minimum of four years' experience
in neonatology, pediatrics, blood banking, infectious disease
or a related field.
(5) A milk bank shall be overseen by a board of
directors or similar body, which shall be responsible for the
oversight of the milk bank's operating, regulatory and
compliance efforts and the work of the managing director, the
medical director and the committee.
(b) Record retention.--Each licensed milk bank shall
maintain the following records in a manner determined by the
department in an easily accessible location at the milk bank:
(1) An individual file on each milk donor, including the
donor's consent to participate in the program and the result
of each laboratory test performed prior to donation and
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during the duration of the donation. Direct or indirect
identifying information for an individual donor may not be
disclosed except with the written consent of the individual
donor.
(2) Records providing for the tracing of each donated
milk container from donor to distribution shall include the
following:
(i) Each donor identified by an identification
number.
(ii) The information from each container's affixed
identification tag.
(iii) If used, the identity of the satellite milk
depot, the time and date of receipt by the satellite milk
depot and the information relating to the transportation
of the milk.
(3) The dates that the donor milk was pasteurized,
distributed and used.
(4) Identifying information for milk pooled from
multiple donors, which shall also be separately recorded and
maintained.
(5) Bacteriological testing and dates for each batch of
donor milk.
(6) Refrigeration and freezer temperatures.
(7) Tracking and shipping information for the
distribution of donor milk by facility or by specific
outpatient use.
(c) Disclosure of relationships.--A licensed milk bank
shall notify the department within 10 days of establishing a
relationship with a dispensary or satellite milk depot.
(d) License display.--A licensed milk bank shall display the
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license in a prominent place at the milk bank's main location.
Section 6. Donation, processing and distribution of donor milk.
(a) Donor qualifications.--Potential donors of donor milk
shall:
(1) Be medically screened initially and periodically
reassessed to determine conditions and behaviors that may
affect the quality or nutritional value of the donor's milk
or do harm to the donor herself.
(2) Provide consent for the milk bank to contact the
donor's health care providers, who can grant approval for the
donor and the donor's baby to be medically screened and blood
tested to ensure the health of the potential donor and the
donor's baby and to ensure the donor milk is free of any
chemical, disease or substance that could injure an infant
receiving the milk.
(3) Be excluded from donation for a documented infection
by a bloodborne pathogen or for other acute or chronic
infectious diseases.
(4) Be temporarily precluded from donating milk if the
donor:
(i) Uses medications contraindicated during
breastfeeding or tobacco or other substances as may be
identified by the department.
(ii) Has a systemic chronic disease or nutritional
deficiency as identified by the donor's or the donor's
infant's health care provider.
(iii) Has a history of exposure to possible
environmental contaminants, including lead or mercury.
(iv) Lacks the ability to understand and follow
directions regarding the sanitary collection and storage
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of donor milk.
(b) Donor milk processing.--Donor milk shall be processed in
accordance with the following:
(1) An approved pasteurization or processing method,
including the Holder pasteurization method or another method
approved by the department, the United States Food and Drug
Administration or a professional organization, shall be used
to inactivate pathogens in donor milk.
(2) Post-pasteurization bacteriologic cultures shall be
performed.
(3) Containers of unprocessed donor milk shall be
labeled with the donor's identification number and the date
of collection.
(4) Frozen, unprocessed donor milk held at a satellite
milk depot shall identify the location, along with the date
and time of receipt and transportation.
(5) Each container of processed donor milk shall be
properly labeled with the expiration date, batch number and
name of the milk bank specific to the milk contained in the
bottle.
(c) Storage.--Donor milk shall be stored in accordance with
the following:
(1) Proper refrigeration and freezer capability shall be
available at each milk bank, with appropriate thermometer
calibration performed no less frequently than annually. The
thermometer on each refrigerator and freezer used for the
storage of donor milk shall be visually or mechanically
monitored daily for possible fluctuations in temperature that
could impact the quality of the donor milk.
(2) Packing of processed milk shall be documented using
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containers that are approved by the United States Food and
Drug Administration as food safe vessels for both heating and
freezing.
(3) Donor milk shall be stored and transported frozen at
a proper temperature and under conditions that protect the
milk from contamination, thawing and refreezing.
(4) Donor milk shall be shipped in clean, insulated
containers using packing material to minimize contamination
of the outside of the bottles during transportation.
Section 7. Duties of department.
(a) Licensure of milk banks.--The department shall:
(1) Regulate the operation of milk banks that handle and
distribute donor milk in this Commonwealth.
(2) Issue licenses to milk banks deemed compliant with
this act.
(b) Review of professional association guidelines.--
(1) The department shall review and approve professional
association guidelines to ensure that the guidelines in use
maintain the necessary requirements and standards of review
for the safe operation and certification of licensees in this
Commonwealth. If, at any time, the department determines that
the professional association guidelines do not maintain
necessary requirements and standards of review for the safe
operation and certification of licensees, licensees must
satisfy the requirements under paragraph (2).
(2) The department shall adopt standards and
requirements for licensure separate from those of the
professional association guidelines referenced in paragraph
(1) which the department determines are sufficient to
maintain the safe operation and certification of licensees.
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(c) Milk bank compliance.--To be licensed by the department,
a milk bank must satisfy the professional association guidelines
referenced in subsection (b)(1) or the standards and
requirements established by the department under subsection (b)
(2), as applicable.
(d) Application requirements.--The department shall develop
a standard written application for a license, which shall
include at least the following:
(1) The name and location of the milk bank.
(2) The name and address of the managing director
responsible for the milk bank's day-to-day operations and of
the medical director of the milk bank.
(3) The education and experience of each person in a
supervisory or technical role in the operation of the milk
bank.
(4) A description of the physical facilities, locations,
equipment, sources of materials and methods of processing,
storage and distribution of donor milk.
(5) A description of each technical procedure used in
the routine operation of the milk bank.
(6) Any relationship between the applicant and either a
dispensary or satellite milk depot.
(7) Any other information required by the department.
(e) Inspection of facilities and documentation.--The
department shall inspect a milk bank's physical facilities and
the physical facilities of a dispensary or satellite milk depot
with which the licensee has a relationship and shall examine
all required documentation maintained by the milk bank prior to
licensure and at any time deemed necessary by the department.
(f) Contents of license.--A license shall display the
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following information:
(1) The name and address of the licensee and the
location of all facilities, dispensaries and affiliated
satellite milk depots authorized under the license.
(2) The name and address of the managing director
responsible for the milk bank's day-to-day operations and of
the medical director of the milk bank.
(3) The signature of the secretary.
(g) Submission of professional association accreditation.--
(1) A licensee belonging to a professional association
shall submit the licensee's professional association
certification information to the department within 30 days of
each inspection and accreditation by the professional
association.
(2) A licensee belonging to a professional association
shall notify the department within 72 hours when membership
in a professional association is terminated for any reason.
(h) Revocations.--Before the department suspends or revokes
a license issued under this act, the department shall provide
written notification to the licensee specifying the reasons for
the revocation or suspension and indicating a time and place for
a hearing to be held within 30 days of the notification.
Section 8. Violations.
(a) Prohibitions.--The following shall be prohibited:
(1) The operation of a milk bank in this Commonwealth by
a person not licensed under this act.
(2) The direct or indirect sale of human milk for profit
or a service fee by a person not licensed under this act.
(3) Remuneration of value provided to a milk donor by an
entity, except as permitted under section 9(c).
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(b) Penalties.--A violation of this section shall constitute
a misdemeanor of the third degree.
Section 9. Exceptions.
(a) Hospital.--A milk bank located in this Commonwealth and
regulated by the department through a hospital licensure process
shall be exempt from this act if the entity distributes donor
milk solely within that hospital to inpatients or outpatients.
(b) Availability of milk.--If facilitated by a milk bank
licensed under this act which lacks access to donor milk or a
specific type of milk ordered or prescribed to a Pennsylvania
resident, that donor milk may be procured from an out-of-State
milk bank approved by a professional organization or, if
necessary, by the department.
(c) Donor remuneration.--Notwithstanding the definitions of
"donor" and "donor milk" under section 3, the department may
exempt a milk bank from the requirement that donors provide milk
voluntarily for no remuneration. In determining whether to grant
this exception, the milk bank must demonstrate to the department
that:
(1) the exemption based on this limited circumstance was
sought prior to remunerating donors in this Commonwealth;
(2) the practices are satisfactorily maintained to
protect public health and the safety of the donor milk
recipient, the donor and the donor's baby, based on commonly
accepted medical standards; and
(3) any additional standards required by the department
reasonably necessary to ensure compliance with paragraph (2)
are implemented.
Section 10. Reports.
Starting in the second odd-numbered year after the effective
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date of this section, and each odd-numbered year thereafter, the
department shall prepare a report on the operation of milk banks
in this Commonwealth in accordance with the following:
(1) The report shall include the following information:
(i) The number of licensed milk banks in this
Commonwealth.
(ii) The address, including the county, for each
licensed milk bank.
(iii) A summary of the amount of milk donated,
processed and distributed by each milk bank organized by
facility type.
(iv) Any other information deemed necessary by the
department.
(2) The report shall be provided to:
(i) The chairperson and minority chairperson of the
Health and Human Services Committee of the Senate.
(ii) The chairperson and minority chairperson of the
Health Committee of the House of Representatives.
Section 11. Licensure application and regulations.
(a) Application.--
(1) Upon the effective date of this subsection, the
department shall create an application for the licensure of
milk banks.
(2) The department shall begin accepting applications
for the licensure of milk banks 120 days after the effective
date of this subsection.
(b) Regulations.--The department may promulgate rules and
regulations to administer and enforce this act.
Section 12. Effective date.
This act shall take effect as follows:
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(1) This section and section 11 of this act shall take
effect immediately.
(2) The remainder of this act shall take effect in 120
days.
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