Regular Session 2017-2018 Senate Bill 1263 P.N. 2016

PRINTER'S NO. 2016

THE GENERAL ASSEMBLY OF PENNSYLVANIA

SENATE BILL

No.

1263

Session of

2018

INTRODUCED BY BAKER, SCHWANK, BREWSTER, RAFFERTY, VULAKOVICH,

WHITE, YUDICHAK, TARTAGLIONE, STEFANO, COSTA, BARTOLOTTA AND

BLAKE, SEPTEMBER 25, 2018

REFERRED TO HEALTH AND HUMAN SERVICES, SEPTEMBER 25, 2018

AN ACT

Providing for licensure of milk banks; imposing powers and

duties on the Department of Health; and prescribing

penalties.

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) Mothers' 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, such as those born

prematurely, with low birth weight or congenital or acquired

conditions, derive significant health benefits from receiving

human milk.

(3) Necrotizing enterocolitis, a devastating and

preventable complication that attacks and kills intestinal

tissue, 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 such as those

born prematurely.

(4) Mothers of medically vulnerable babies often face

unique obstacles to producing enough milk for their own

babies. When mothers' own milk is not available, donor human

milk can provide a life saving 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.

(7) The use of donor milk is safe when appropriate

measures are used to screen volunteer donors, and to collect,

store and process the milk for distribution through licensed

milk banks.

(8) Banked donor milk is predominantly pasteurized to

remove pathogens and frozen for storage and shipping.

Volunteer donors are carefully screened and blood-tested to

ensure that they are healthy and their milk is free from any

chemical, disease or substance that could be injurious to

high risk infants.

(9) The Human Milk Banking Association of North America

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(HMBANA) 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" or "(AAP)." An American

professional association of pediatricians that issues clinical

guidelines governing 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 volunteer 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)(3).

"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 an acute care hospital, birth center,

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lactation center, pharmacy, dispensary or medically approved

outpatient by a milk bank licensed in this Commonwealth.

"Donor." A lactating woman with an excess supply of human

milk, who voluntarily contributes milk to a milk bank after

being medically screened and approved for milk donation and who

receives no remuneration for the donation of milk.

"Donor milk." Human milk derived from a properly screened

donor that is voluntarily donated 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 the

provisions of this act.

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

volunteer medically screened human donors and distributes the

donor milk to medically fragile children other than the donor's

own child based on a healthcare 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,

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corporation, institution, agency or other similar type entity.

"Pharmacy." A store where medicinal drugs are dispensed and

sold.

"Processing." The standards and techniques approved by the

department for removing pathogens from donor milk and ensuring

its safety.

"Professional association." A professional association that

establishes and requires member compliance with guidelines for

the operation of human milk banks throughout North America. The

term includes, but is not limited to, HMBANA.

"Professional association guidelines." Guidelines issued by

a professional association that govern the operation of milk

banks in the United States.

"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.

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

process of evaluating prospective volunteer donors by a milk

bank to determine the acceptability of the donor milk based on

past medical history, medication use, present state of health

and indicated laboratory studies and which process has been

approved prior to implementation by the department.

"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.

Section 4. Licensure of milk banks.

(a) General rule.--A milk bank operating or seeking to

operate in this Commonwealth must apply to the department and

obtain a license. The department shall issue a license to a milk

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bank that is certified as a member in good standing by a

professional association subject to the review and approval

process specified in section 6(c) or that is otherwise in

compliance with the requirements of this act.

(b) Suspension or revocation of license.--The department may

suspend or revoke a license issued under subsection (a) for

noncompliance with the provisions of this act.

Section 5. Administration of milk banks.

(a) Licensee requirements.--

(1) A licensee shall develop and ensure the

implementation of policies and procedures consistent with

professional association guidelines or the requirements of

this act.

(2) A licensee shall appoint a person to serve as the

chief operating officer of the licensee. The chief operating

officer shall be responsible for the day-to-day operation of

the licensee.

(3) A licensee shall be managed by a board of directors

or similar body. Among other responsibilities, the board of

directors shall be responsible for the appointment of the

chief operating officer, a medical director and a medical

advisory committee.

(4) The medical director must be a licensed physician

with a minimum of four years' experience in neonatology,

pediatrics, blood banking or a related field. The medical

director shall serve as a member of the board of directors of

the licensee.

(5) The medical advisory committee shall be composed of

physicians and other allied health personnel with experience

in neonatology, blood banking, nutrition and other related

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expertise. At least one member of the medical advisory

committee must have expertise in infectious diseases.

(b) Donor qualifications.--

(1) A person who volunteers to provide donor milk shall

successfully complete the donor screening process.

(2) In addition to any other provisions of the donor

screening process, the following shall apply:

(i) A donor shall authorize a milk bank to contact

both her health care provider and the health care

provider for the donor's baby so that the donor and the

donor's baby may be medically screened and blood-tested

to ensure the health of the potential donor and her baby

and to ensure that the donor milk is free from any

chemical, disease or substance that could be injurious to

an infant receiving it.

(ii) A person who is at high risk for bloodborne

pathogens or other acute and chronic infectious diseases

shall be excluded from serving as a donor.

(iii) Donations may be precluded for:

(A) Use of medications not approved by the

department, tobacco, alcohol or other substances

identified by the department.

(B) Systemic chronic diseases or nutritional

deficiencies.

contaminants.

(D) The inability or failure to follow

directions regarding sanitary collection and storage

of donor milk or other relevant contraindications to

donation established by the department.

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of the following requirements for donor milk processing:

(1) Pasteurization or processing methods approved by the

department shall be used to remove pathogens from donor milk,

including the Holder pasteurization method.

(2) Post-pasteurization bacteriologic cultures shall be

performed.

(3) Containers holding unprocessed donor milk shall be

labeled with the donor's identification number and collection

date. Unprocessed donor milk stored at a satellite milk depot

shall be labeled with the location of the milk depot and the

date and time of receipt by the milk depot and, after

transport of the milk to the milk bank, the date of such

transport.

(4) Processed milk shall be documented and packaged in

Bisphenol-A and phthalate-free containers that are FDA-

approved food safe vessels for heating and freezing. Each

container shall be labeled with the expiration date, batch

number and licensee name. Labeling shall be compatible with

hospital donor milk inventory and feeding systems, as

appropriate.

(5) Donor milk shall be stored and transported at a

temperature safe from contamination, thawing and refreezing.

(6) Donor milk shall be shipped in clean, insulated

containers and packed to minimize contamination of the

outside of the bottle during transport. Techniques shall be

used in packing to ensure the product remains frozen.

(d) Donor milk storage.--

(1) Proper refrigeration and freezer capability shall be

used by a licensee, with thermometer calibration performed at

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least annually.

(2) Refrigerators and freezers used to store donor milk

shall be visually or mechanically monitored daily for

temperature fluctuations that could affect the donor milk

quality.

(e) Maintenance of records.--A licensee shall maintain the

information required under this subsection in a manner

determined by the department for inspection:

(1) An individual file for each milk donor, including

the donor's consent for participation in the milk bank

program and the results of all clinical laboratory tests

performed prior to approval as a donor and during

participation in the program. Information that would directly

or indirectly identify the donor may not be disclosed by the

licensee to any person, other than authorized agents of the

department, without the written consent of the donor.

(2) Records of milk donation filed by donor

identification number, including information from container

identification tags as provided by subsection (c). All

distributed milk shall be capable of being traced back to the

individual donors.

(3) The pasteurization date of the donor milk and the

date the donor milk was distributed or used. Identifying

information for donor milk pooled from multiple donors shall

be separately recorded and maintained by the donor.

(4) Bacteriological testing results and dates for each

batch of donor milk.

(5) Tracking and shipment information regarding the

distribution of donor milk by facility or specific outpatient

use.

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(6) Refrigeration and freezer temperature records for at

least one year after distribution or disposal by the

licensee.

(7) Licensee operating policies and procedures.

(f) Submission of professional association accreditation.--

(1) A licensee shall submit professional association

certification information to the department within 30 days of

each professional association inspection and accreditation of

the licensee, as applicable.

(2) A licensee shall notify the department within 72

hours when membership in a professional association is

terminated for any reason.

(g) Display of license.--A licensee shall display the

license in a prominent place at the main facility of the

licensee.

(h) Disclosure of relationships.--A licensee shall notify

the department within seven days of establishing a relationship

with a dispensary or satellite milk depot.

Section 6. Duties of department.

(a) General rule.--The department shall regulate the

operation of licensees that handle and distribute donor milk in

this Commonwealth.

(b) License required.--The department shall issue licenses

in accordance with the requirements of this act.

(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

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the guidelines in use by the professional association do not

maintain necessary requirements and standards of review for

the safe operation and certification of licensees, licensees

must satisfy the requirements provided for in 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.

(3) Licensees may satisfy either the standards and

requirements established by the department or the standards

of the professional association referenced in paragraph (1).

(d) Application requirements.--The department shall develop

a standard written application for a license, which shall

provide for all of the following:

(1) The name and location of the applicant.

(2) The name and address of the chief operating officer

and medical director of the applicant.

(3) The education and experience history of all persons

having supervisory or technical duties related to the

operation of the applicant.

(4) A description of the physical facilities, location,

equipment, sources of materials and methods of processing,

storage and distribution of donor milk.

(5) A description of all technical procedures used in

the routine operations of the applicant.

(6) Any relationship between the applicant and either a

dispensary or satellite milk depot.

(7) Such additional information as the department may

require.

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(e) Inspection.--

(1) Prior to issuing a license to an applicant, the

department shall inspect the applicant's physical facilities

and, at the department's discretion, the physical facilities

of any dispensary or milk depot with which the licensee has a

relationship, shall examine all required documentation.

(2) The department may subsequently inspect a licensee

at any time deemed appropriate by the department upon

reasonable notice.

(f) Issuance of license.--

(1) The department shall issue a license if the

department is satisfied that the applicant has complied with

the provisions of this act and applicable rules and

regulations adopted by the department.

(2) 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 effective date of this section or the date

that an application for a license is first made available to

prospective licensees pursuant to this act.

(g) Expiration of license.--A license shall expire two years

after the date of issuance unless renewed. A license may be

renewed in the same manner as the issuance of the original

license and upon payment of a renewal application fee as

specified in section 7.

(h) Contents and signing of license.--A license issued by

the department shall include:

(1) The name and address of the licensee and the

location of all facilities, dispensaries and affiliated

satellite milk depots authorized under the license.

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(2) The name and address of the chief operating officer

and medical director.

(3) The signature of the secretary.

(i) Statement of grounds for denial of license.--If the

department does not issue a license to an applicant within six

months after the filing of an application, the license shall be

deemed denied. When an application is denied or deemed denied,

the department shall, within seven days, state the grounds and

reason for its refusal, in writing, with a copy to the

applicant.

(j) Hearings and appeals.--If an applicant is denied a

license, the applicant may request and receive a hearing before

the secretary, if the hearing request is made within 30 days

after receiving notice of denial.

(k) Revocation of license.--

(1) A license may be suspended or revoked by the

department for a violation of any provision of this act.

(2) Before the department suspends or revokes a license,

written notification shall be provided to the licensee. The

notification shall specify the reason for revocation or

suspension and indicate a time and place for a hearing on the

matter, to be held within 30 days of notification.

(l) Ongoing review.--The department shall conduct an ongoing

review of the clinical guidelines issued by the American Academy

of Pediatrics regarding the assessment and determination of

medical necessity for the use of donor milk to treat medically

fragile infants and children.

Section 7. Licensure fees.

In order to obtain licensure by the department, an applicant

shall submit an initial licensure fee of $1,000, with a $250 fee

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for each renewal thereafter. All money derived from the payment

of licensure fees under this act shall be used for the

administration of this act.

Section 8. Exceptions.

(a) General rule.--A milk bank located in this Commonwealth

and otherwise regulated by the department through its hospital

licensure process shall not be subject to the requirements of

this act, provided the milk bank's distribution of donor milk is

confined to the hospital and the outpatients of the hospital.

(b) Milk banks outside this Commonwealth.--In the event a

licensee lacks access to donor milk or a specific type of donor

milk prescribed to an individual residing in this Commonwealth,

a milk bank located outside of Pennsylvania that is a member of

a professional association may distribute donor milk within this

Commonwealth at the specific direction and in accordance with

the instructions of a licensee.

Section 9. Prohibitions and penalty.

(a) License required.--No person may operate a milk bank in

this Commonwealth unless licensed by the department in

accordance with the provisions of this act.

(b) Prohibited practices.--The following practices shall be

prohibited in this Commonwealth:

(1) The direct or indirect sale of donor milk for profit

by an entity not licensed in this Commonwealth.

(2) Monetary remuneration or any other remuneration of

value provided to an individual for the donation of donor

milk.

(1) A violation of subsection (b)(1) shall be a

misdemeanor of the third degree.

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(2) A violation of subsection (b)(2) shall be a summary

offense.

Section 10. Biennial report.

(a) Duty to prepare and file.--The department shall prepare

a biennial report by July 1 in odd-numbered years regarding the

operation of milk banks in this Commonwealth. The report shall

be filed with the chairman and minority chairman of the Health

and Human Services Committee of the Senate and the chairman and

minority chairman of the Health Committee of the House of

Representatives.

(b) Contents.--The report shall include:

(1) The number, location and county of licensees.

(2) A summary of the amount of donor milk donated,

processed and distributed by each licensee by type of medical

facility.

(3) Any other information the department may deem

necessary.

Section 11. Regulations.

The department may promulgate regulations for the

implementation of this act.

Section 12. Effective date.

This act shall take effect in 120 days.

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