Regular Session 2019-2020 Senate Bill 0811 P.N. 1118

PRINTER'S NO. 1118

THE GENERAL ASSEMBLY OF PENNSYLVANIA

SENATE BILL

No.

811

Session of

2019

INTRODUCED BY BAKER, SCHWANK, ARGALL, BARTOLOTTA, KILLION,

STEFANO, J. WARD, COSTA, HUGHES, BREWSTER, BLAKE, YUDICHAK,

TARTAGLIONE, LEACH, HAYWOOD AND FONTANA, AUGUST 7, 2019

REFERRED TO HEALTH AND HUMAN SERVICES, AUGUST 7, 2019

AN ACT

Regulating milk banks that provide human donor 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.

(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.

(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. Milk donors are carefully screened and

blood tested to ensure the donors are healthy and that the

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donor milk is free from any infectious diseases or substances

that could be harmful to high-risk infants.

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.

"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 formed by a milk

bank in accordance with section 5(a)(6).

"Department." The Department of Health of the Commonwealth.

"Dispensary." A center that has an agreement with a milk

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, medically

approved outpatient facility or directly to an outpatient by a

milk bank licensed in this Commonwealth.

"Donor." Subject to the provisions of section 10, a

lactating woman with an excess supply of human milk who

voluntarily and without remuneration contributes milk to a milk

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bank after being medically screened and approved for milk

donation.

"Donor milk." Subject to the provisions of section 10, human

milk derived from a properly screened donor that is voluntarily

donated without remuneration to a milk bank and processed for

distribution.

"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.

"Milk bank." An entity that collects donor milk from

properly screened human donors and distributes the donor milk to

medically fragile children, other than a donor's own child,

based on a health care provider's order or prescription, using

storage, processing and shipping methods required by the

department.

"NICU." The neonatal intensive care unit of a licensed acute

care hospital.

"Person." A natural person, 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

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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.

"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 licensee to collect and store donor milk for

shipping to the licensee.

"Screening donors" or "donor screening process." The process

of evaluating prospective donors by a milk bank to determine the

acceptability of donor milk based on a donor's past medical

history, medication use, current state of health and indicated

laboratory studies through a process as approved by the

department.

"Secretary." The Secretary of Health of the Commonwealth.

"Storage." The method of holding and freezing donor milk as

approved by the department in connection with the donor milk's

collection or processing prior to distribution.

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

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section 7(d).

(2) The entity meets one of the following requirements:

(i) is certified as a member in good standing of a

nationally recognized professional association for the

operation of milk banks; or

(ii) is otherwise determined to be in compliance

with the requirements of this act.

(1) Prior to the issuance of a license, the department

shall perform an inspection in accordance with section 7(e).

(2) Notwithstanding the requirement of paragraph (1),

the department need not inspect the facility if:

(i) the facility has a valid license or

accreditation from another state and the department is

satisfied that the other state's license addresses

appropriate health and safety concerns; or

(ii) the facility is registered and in good standing

with the United States Food and Drug Administration, and

the department has received confirmation that the

facility has satisfactorily addressed all observations

raised in previous inspections.

(d) Denial.--

(1) If the department denies an application, the

department shall provide the applicant with a written

explanation of the reason for the denial.

(2) An applicant that is denied a license is entitled to

a hearing if the applicant requests a hearing within 30 days

of the receipt of the denial.

(e) Fee.--The department shall charge the following fees for

the administration and implementation of this act:

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(1) An applicant 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 shall expire two years after the

date of the issuance of the license.

(g) Renewal.--A license 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 if

the department determines that, in accordance with section

7(h), the licensee is not in compliance with this act.

(2) The department shall provide written notification

and a hearing in accordance with section 7(h) prior to the

suspension or revocation of a license.

(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 the milk bank's

application or pending a decision on whether the exemption

specified in section 10 applies, if the application is made

within 120 days of the later of the effective date of this

section or the date that applications for licenses are first

made available to prospective licensees under this act.

Section 5. Operation of milk bank.

(a) Licensee requirements.--

(1) Each milk bank shall develop and ensure the

implementation of policies and procedures consistent with the

requirements of this act.

(2) No donor milk or donor-milk-derived product may be

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distributed by a milk bank without:

(i) testing to address associated risks as

identified by the guidelines of the milk bank under

section 7(c); and

(ii) otherwise satisfying the provisions of section

(3) Each milk bank shall be operated by a managing

director responsible for the day-to-day operations of the

milk bank.

(4) A board of directors or similar body shall oversee

the milk bank's operating, regulatory and compliance efforts

and the work of the managing director, the medical director

and the medical advisory committee.

(5) 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.

(6) A milk bank shall have a medical advisory committee

to consult on milk bank operations, which advisory committee

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 medical advisory committee must have experience

in the field of infectious diseases or biologics

manufacturing.

(b) Record retention.--A licensee shall maintain the

following records in a manner determined by the department in an

easily accessible location:

(1) An individual file on each milk donor, including the

donor's consent to participate in the program and the result

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of each laboratory test performed prior to donation and

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 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 that is separately recorded and maintained.

(5) Bacteriological testing and dates for each batch of

donor milk.

(6) Refrigeration and freezer temperatures.

(7) Tracking and shipment information for the

distribution of donor milk by facility or by specific

outpatient use.

the department within 10 days of establishing a relationship

with a dispensary or satellite milk depot.

(d) License display.--A licensee shall display the license

in a prominent place at the licensee's main location.

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Section 6. Donation, processing and distribution of donor milk.

(a) Donor qualifications.--A potential donor shall:

(1) Undergo an initial medical screening and be

periodically reassessed to determine conditions and behaviors

that may affect the quality or nutritional value of the

donor's milk or that may do harm to the potential donor.

(2) Provide consent for the milk bank to contact:

(i) the donor's health care providers and medically

screen and blood test the potential donor to ensure the

health of the potential donor and to ensure the donor

milk is free of any chemical, disease or substance that

could injure an infant receiving the milk; and

(ii) the health care providers of the donor's

biological baby to verify that the baby is achieving

adequate growth, except in cases of bereavement,

surrogacy or adoption.

(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 and mercury.

(iv) Lacks the ability to understand and follow

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directions regarding the sanitary collection and storage

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 and Vat pasteurization methods or

another method approved by the department, the United States

Food and Drug Administration or a professional association,

shall be used to inactivate pathogens in donor milk.

(2) Postpasteurization 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 or the bar code that supplies this information.

(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.

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.

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(2) Packing of processed donor milk shall be done using

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

donor 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) General rule.--The department shall regulate the

operation of milk banks that handle and distribute donor milk in

this Commonwealth and issue licenses to milk banks in compliance

with the requirements of this act.

(b) Review of milk bank 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 guidelines in use by a professional association do not

maintain necessary requirements and standards of review for

the safe operation and certification of licensees, licensees

must satisfy the requirements of paragraph (2).

(2) The department shall adopt standards and

requirements for licensure separate from those of the

professional association guidelines under paragraph (1) which

the department determines are sufficient to maintain the safe

operation and certification of licensees.

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a milk bank must satisfy either the guidelines of the

professional association under 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.--

(1) The department shall inspect a milk bank's physical

facilities and the physical facilities of any dispensary or

milk depot with which the licensee has a relationship and

shall examine all required documentation maintained by the

milk bank prior to licensure and when deemed necessary by the

department.

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(2) Notwithstanding the requirement of paragraph (1),

the department need not inspect the facility if:

(i) the facility has a valid license or

accreditation from another state and the department is

satisfied that the other state's license addresses

appropriate health and safety concerns; or

(ii) the facility is registered and in good standing

with the United States Food and Drug Administration, and

the department has received confirmation that the

facility has satisfactorily addressed all observations

raised in previous inspections.

(f) Contents of license.--A license shall display the

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 day-to-day operations of the milk bank

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

must notify the department within 72 hours if membership in a

professional association is terminated for any reason.

(h) Revocations.--Before the department suspends or revokes

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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 milk bank not licensed under this act.

(3) Remuneration of value provided to a milk donor by a

milk bank, except as permitted under section 10.

(4) The sale or distribution of donor milk or any donor-

milk-derived product in violation of section 5(a)(2).

(b) Penalties.--A violation of this section shall constitute

a misdemeanor of the third degree.

Section 9. Exceptions.

(a) Hospitals.--A milk bank located in this Commonwealth and

regulated by the department through a licensure process as a

hospital is exempt from this act if the hospital distributes

donor milk solely within the hospital to inpatients or

outpatients, or both.

(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 accredited by a professional association or approved

by the department.

Section 10. Exemptions.

(a) General rule.--Notwithstanding the definitions of

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"donor" and "donor milk" under section 3, the department may

exempt a milk bank from the requirement that donors provide

donor milk voluntarily and for no remuneration. In order to be

granted this exemption, the milk bank must satisfy the

following:

(1) The milk bank may not sell, donate or distribute

donor milk and donor-milk-derived products for which the

donor has been remunerated without testing for controlled

substances as determined by the department. The department

may, at any time, require additional testing for donor milk

and donor-milk-derived products.

(2) The milk bank may not sell, donate or distribute

donor milk and donor-milk-derived products for which the

donor has been remunerated without obtaining medical

verification that the donor's biological infant is achieving

adequate growth.

(3) The milk bank must meet or exceed any additional

standards required by the department reasonably necessary to

protect public health and the recipient of the donor milk,

the donor and the donor's baby.

(b) Construction.--If the milk bank is exempt under

subsection (a), the donor of the human milk shall be considered

a "donor" as defined in section 3 and the human milk provided by

the donor shall be considered "donor milk" as defined in section

a misdemeanor of the third degree.

(d) Applicability.--The provisions of subsection (a)(1) and

(2) shall not apply to milk banks that do not remunerate donors.

Section 11. Reports.

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Beginning in the second odd-numbered year after the effective

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 licensees in this Commonwealth.

(ii) The address, including the county, for each

licensee.

(iii) A summary of the amount of milk donated,

processed and distributed by each licensee 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 12. Licensure application.

Upon the effective date of this section, the department shall

create an application for the licensure of milk banks. The

department shall begin accepting applications for licensure of

milk banks 120 days after the effective date of this section.

Section 13. Regulations.

The department may promulgate rules and regulations to

administer and enforce this act.

Section 14. Effective date.

This act shall take effect as follows:

(1) This section and sections 12 and 13 shall take

effect immediately.

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(2) The remainder of this act shall take effect in 120

days.

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