See other bills
under the
same topic
PRINTER'S NO. 3740
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No.
2516
Session of
2018
INTRODUCED BY OBERLANDER, YOUNGBLOOD, READSHAW, SCHLOSSBERG,
KLUNK, V. BROWN, TOOHIL, MURT, CHARLTON, NEILSON,
CALTAGIRONE, HILL-EVANS, KINSEY, DALEY, JAMES, MENTZER, FEE,
CUTLER, GROVE, TOEPEL, R. BROWN, SCHLEGEL CULVER, ENGLISH,
BOBACK, HAHN, GILLEN, BARBIN, WARD, CEPHAS, BRADFORD AND
CRUZ, JUNE 19, 2018
REFERRED TO COMMITTEE ON HEALTH, JUNE 19, 2018
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 weight or with congenital or
acquired conditions, derive significant health benefits from
receiving human milk.
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
(3) Necrotizing enterocolitis, a devastating
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, including those born
prematurely.
(4) Mothers of medically vulnerable babies often face
unique obstacles to producing enough milk for their babies.
When 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.
(7) The use of donor milk is safe when appropriate
measures are used to screen volunteer donors and 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 the volunteers are healthy and that the milk is
free from any chemicals, diseases or substances that could be
damaging to high-risk infants.
20180HB2516PN3740 - 2 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
(9) The Human Milk Banking Association of North America
is a professional association that established 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:
"Department." The Department of Health of the Commonwealth.
"HMBANA." The Human Milk Banking Association of North
America.
"Hospital." A hospital licensed by the department under the
act of July 19, 1979 (P.L.130, No.48), known as the Health Care
Facilities Act.
"Milk bank." An entity which collects and stores donated
human milk for distribution in accordance with an order or
prescription from a health care provider.
"Satellite milk depot." An entity that regularly collects
and stores donor milk for a licensed milk bank for the purposes
of holding and shipping.
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 has submitted a completed application
developed by the department and including all the information
required in section 7.
(2) The entity is:
20180HB2516PN3740 - 3 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
(i) certified as a member in good standing of the
HMBANA;
(ii) certified as a member in good standing of a
nationally recognized accrediting organization for the
operation of milk banks; or
(iii) 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.
(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
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
20180HB2516PN3740 - 4 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
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, 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 prior to the suspension or
revocation.
(i) Operation prior to effective date.--If an application is
submitted within 180 days of the effective date of this section,
an entity operating as a milk bank prior to the effective date
of this section may continue to operate without a license until
the department approves or denies the application.
Section 5. Operation of milk bank.
(a) Duties of director.--Each milk bank shall be operated by
a director who shall do all of the following:
(1) Develop and implement policies and procedures
consistent with the HMBANA guidelines and the requirements of
this act.
(2) Appoint a medical director who is a licensed
physician with a minimum of four years' experience in
neonatology, pediatrics, blood banking or a related field.
(3) Appoint a medical advisory committee for the milk
bank which shall include physicians and other allied health
personnel who have experience in neonatology, blood banking,
nutrition and other related expertise. At least one member
must have experience in the field of infectious diseases. The
committee shall be consulted on the appointment of the
20180HB2516PN3740 - 5 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
medical director and shall oversee the operation of the milk
bank and develop governing policies.
(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
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 shall also be separately recorded and
maintained.
(5) Bacteriological testing and dates for each batch of
donor milk.
(6) Refrigerating and freezer temperatures.
20180HB2516PN3740 - 6 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
(7) Tracking and shipping organization for the operation
of milk banks, within 30 days of each inspection and
accreditation of the milk bank.
(c) License display.--A licensed milk bank shall display the
license in a prominent place at the milk bank's main location.
Section 6. Process of donation and distribution.
(a) Donor qualifications.--Potential donors who volunteer to
provide donor milk, 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 do harm to the donor herself.
(2) Provide consent for the milk bank to contact her
health care providers, who can grant approval for the donor
and her baby to be medically screened and blood tested to
ensure the health of the potential donor and her 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 permanently excluded from donation for a history
of or current behavior that puts her at an increased risk for
bloodborne pathogens or other acute or chronic infectious
diseases.
(4) Be temporarily precluded from donating milk if the
donor:
(i) Uses medications, tobacco, alcohol or other
substances.
(ii) Has a systemic chronic disease or nutritional
deficiency.
(iii) Has been exposed to possible environmental
contaminants.
20180HB2516PN3740 - 7 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
(iv) Lacks the ability to understand and follow
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 pasteurization method or another method
approved by the HMBANA, shall be used to remove pathogens
from 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) Packaging of processed milk must be documented using
Bisphenol A and phthalate-free containers that are approved
by the United States Food and Drug Administration as food
safe vessels for both heating and freezing. 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. Labeling on
each container shall be made compatible with hospital donor
milk inventory and feeding systems.
(6) Donor milk shall be stored and transported at a
proper temperature to protect the milk from contamination,
thawing and refreezing.
(7) Donor milk shall be shipped in clean, insulated
20180HB2516PN3740 - 8 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
containers using packing material to minimize contamination
of the outside of the bottles during transportation. Clean
techniques shall be used to pack the milk in order to ensure
the milk remains frozen.
(c) Storage.--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.
Section 7. Duties of department.
(a) Oversight of milk banks.--The department shall regulate
the operation of milk banks that handle and distribute donor
milk in this Commonwealth.
(b) Review of HMBANA guidelines.--The HMBANA guidelines
shall be reviewed every other year to determine if the current
guidelines maintain the necessary requirements and standards of
review for the operation and certification of milk banks in this
Commonwealth. After review, the department may continue to
accept the certification or develop the department's own
standards and requirements for licensure.
(c) Review of American Academy of Pediatrics guidelines.--
The department shall continually review the American Academy of
Pediatrics clinical guidelines on the assessment and
determination of medical necessity for the use of donor milk to
treat medically fragile infants and children.
(d) Application requirements.--The department shall develop
a standard written application for use by an entity applying to
operate a milk bank. The application shall at least include the
20180HB2516PN3740 - 9 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
following:
(1) The name and location of the milk bank.
(2) The name and address of the director and 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 other information required by the department.
(e) Inspection.--The department shall inspect each milk
bank's physical facilities and 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
following information:
(1) The name and address of the milk bank and each
affiliated satellite milk depot.
(2) The name and address of the director and medical
director of the milk bank.
(3) The signature of the Secretary of Health.
(g) 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.
20180HB2516PN3740 - 10 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
(a) Prohibitions.--The following shall be prohibited:
(1) The operation of a milk bank by an unlicensed
individual or entity.
(2) The direct or indirect sale of human milk by an
individual or entity not licensed under this act.
(3) Remuneration of value provided to milk donors.
(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, the milk may be procured from an out-of-State milk
bank which is approved by HMBANA or another nationally
recognized accrediting organization for the operation of milk
banks.
Section 10. Reports.
Starting 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 licensed milk banks in this
Commonwealth.
(ii) The address, including the county, for each
licensed milk bank.
20180HB2516PN3740 - 11 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
(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. 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 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:
(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.
20180HB2516PN3740 - 12 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26