CHAPTER He-P 3000
MATERNAL AND CHILD HEALTH
PART He-P 3001 – 3007 – EXPIRED
Source. #2407, eff 6-30-83, EXPIRED: 6-30-85
PART He-P 3008 NEWBORN DRIED BLOOD SPOT SCREENING, CRITICAL
CONGENITAL HEART DISEASE SCREENING AND NEWBORN HEARING SCREENING
He-P
3008.01 Purpose. The purpose of this part is to
describe the requirements for the screening of all newborns pursuant to RSA
132:10-a, RSA 132:10-aa, and for newborn hearing screening pursuant to RSA
132:10-b, V.
Source. #8529, eff 12-23-05; ss by #9725, eff 7-1-10; ss by #12632, eff
9-28-18; ss by #13530, eff 1-25-23
He-P
3008.02 Scope. This part shall apply to:
(a) Birth
facilities and laboratories performing newborn dried blood spot screening;
(b) Birth
facilities performing newborn hearing screening;
(c) Birth
facilities performing newborn critical congenital heart disease screening;
(d) Providers,
certified midwives, and nurse midwives performing newborn dried blood spot
screening, newborn hearing screening, and critical congenital heart disease
screening, or providing care to infants or children with abnormal screening
results;
(e) Audiologists
providing pediatric diagnostic audiology services; and
(f) Organizations
and agencies providing intervention and early supports and services to children
between the ages of birth and 3 years with hearing conditions.
Source. #8529, eff 12-23-05; ss by #9725, eff 7-1-10; ss by #12632, eff
9-28-18; ss by #13530, eff 1-25-23
He-P
3008.03 Definitions.
(a) “Birth
facility” means the hospital or birthing center where the infant was born.
(b) “Commissioner”
means the commissioner of the New Hampshire department of health and human
services, or his or her designee.
(c) “Critical
congenital heart disease (CCHD) screening” means screening for 7 different
heart disorders that can be detected via pulse oximetry.
(d) “Department”
means the department of health and human services, state of New Hampshire.
(e) “Diagnostic
hearing evaluation” means comprehensive testing of infants to determine type
and classification of hearing loss.
(f) “Dried
blood spot (DBS)” means a specimen of blood obtained from an infant through the
heel stick procedure, which is then applied to a filter paper and dried.
(g) “Early
hearing detection and intervention (EHDI) program” means a department program,
which oversees the newborn hearing screening process in New Hampshire.
(h) “EHDI
database” means the information collection system used by the department for
the reporting of newborn hearing screening, diagnosis, and treatment
information.
(i) “Filter paper” means the department-approved
specimen collection card which is made specifically for the purpose of collecting
an infant’s blood, and which is used by the laboratory for testing.
(j) “Healthcare
provider” means the licensed medical doctor, licensed doctor of osteopathy,
licensed advanced practice nurse, licensed physician’s assistant, or certified
midwife, providing care to a person.
(k) “Laboratory”
means the testing facility authorized by the state of New Hampshire to conduct
DBS testing on its behalf.
(l) “Newborn
hearing screening” means evaluating the hearing status of infants.
(m) “Newborn
screening” means the DBS testing of infants.
(n) “Newborn
screening program (NSP)” means the department program which has responsibility
for managing all aspects of infant DBS screening pursuant to RSA 132:10-a.
(o) “Out
of range (OOR) result” means a DBS test result that is outside of the reference
range shown on the clinical laboratory report.
(p) “Pediatric
audiologist” means a person who specializes in the assessment and rehabilitation
of hearing loss in infants and children.
(q) “Unsatisfactory
specimen” means a DBS specimen which is unacceptable for issuing a laboratory
result interpretation on the formal laboratory report.
Source. #8529, eff 12-23-05; ss by #9725, eff 7-1-10; ss by #12632, eff
9-28-18; ss by #13530, eff 1-25-23
He-P 3008.04 Newborn DBS Screening.
(a) Newborn screening shall be
required for all infants born in the state of New Hampshire, in accordance with
RSA 132:10-a, unless the parent(s) or guardian(s) object.
(b) The
infant’s health care provider shall inform the infant’s parent or guardian of
their right to opt out of the performance of the DBS testing per RSA 132:10-c.
(c) If
the infant’s parent or guardian objects to the performance of DBS testing, he
or she shall provide a statement of dissent for refusal of newborn screening to the
infant’s healthcare provider or designee, subject to the following:
(1) A statement of dissent for refusal
of newborn screening shall be signed and dated by the infant’s parent or
guardian and include:
a. Name of infant;
b. Birth
date;
c.
Street address, city, state, and zip code;
d. Hospital
of birth;
e. Medical
record number; and
f. The
following understandings:
1. “I refuse to have blood taken from my baby to
determine if he or she might have a disorder that can be detected through
newborn screening.”;
2. “I understand that State Law
requires Newborn Screening for all infants born in New Hampshire.”;
3. “I have been offered the Newborn Screening Brochure
and discussed newborn screening with my baby’s doctor, midwife, a member of the
hospital nursing staff, or other healthcare provider.”;
4. “I understand that newborn
screening is done for the early detection of treatable disorders and that
symptoms sometimes do not appear for several weeks or months.”;
5. “I understand that
if undetected and untreated these disorders can cause permanent damage to my child, including serious intellectual disability, growth failure and, in
some cases, death.”; and
6. “The benefits of
newborn screening and the potential danger of not being screened have been explained
to me. My decision to refuse the testing was made freely without force or encouragement
by my doctor, my baby's doctor, hospital personnel or State officials.”;
(2) The statement of dissent for
refusal of newborn screening shall be included in the infant’s medical record;
(3) The infant’s healthcare provider
or designee shall submit a copy of the statement of dissent for refusal of newborn screening to the NSP; and
(4) A copy of the statement of
dissent for refusal of newborn screening shall be provided to the parent or
guardian.
(d) Newborn screening tests
shall be conducted as follows:
(1) The DBS shall be collected
from the infant through the heel stick procedure and directly applied to an
unexpired filter paper obtained from the NSP; and
(2) If the newborn screening
tests are performed by a laboratory other than that used by the NSP, the infant’s healthcare provider
shall request all tests required by the NSP and provide a copy of these test results to the NSP.
(e) For
homebirths, the
attending physician, advanced practice registered nurse, certified midwife, or
designee shall be responsible for conducting newborn screening, as described in
(a) through (d) above, and the collection of the DBS specimen, as described in
He-P 3008.05(a)-(h) below.
(f) The
department
shall restrict the quantity of filter papers made available to birth facilities
during periods when changes to the program are being made.
Source. #8529, eff 12-23-05; ss by #9725, eff 7-1-10; ss by #12632, eff
9-28-18; ss by #13530, eff 1-25-23
He-P 3008.05 DBS
Collection Procedures.
(a) Except
as allowed by (b)-(i) below, the infant’s healthcare
provider or designee shall collect the DBS between 24 and 48 hours after birth.
(b) The
infant’s healthcare provider or designee shall obtain an initial DBS at time of
discharge from a birth facility for infants discharged prior to the first 24
hours of life.
(c) When
the initial DBS is obtained prior to the first 24 hours of life due to early
discharge, the infant’s healthcare provider or designee shall obtain a second
DBS within 48 hours of discharge.
(d) For
infants who are sick, premature, less than 1500 grams or receiving a higher
level of care, the infant’s healthcare provider or designee shall obtain:
(1) An initial DBS between 24
and 48 hours of the infant’s life;
(2) A second DBS at 2 weeks of
age;
(3) Additional repeat DBS specimens at 1 month,
and monthly thereafter; and
(4)
A final DBS specimen upon discharge or transfer from the higher level of
care.
(e) Except
as allowed by (f) below, the infant’s healthcare provider shall ensure that a
DBS is obtained prior to transfer to another medical facility.
(f) If
an infant’s medical condition prohibits DBS collection prior to transfer to
another medical facility, the transferring birth facility shall:
(1) Notify the receiving
medical facility that a DBS has not been obtained; and
(2) Submit a completed filter
paper form without the blood specimen and with a comment explaining the
circumstances preventing the collection of blood.
(g) Upon
notice of non-collection from the birth facility, the receiving medical
facility shall obtain a DBS for screening in accordance with He-P 3008.05.
(h) Infants
receiving a blood transfusion shall have DBS collection performed in the
following manner:
(1) For infants receiving blood
transfusions, the infant’s healthcare provider or designee shall obtain a DBS
prior to transfusion, regardless of the infant’s age;
(2) If the first DBS is
obtained prior to 48 hours after transfusion, then a second DBS shall be
obtained 48 hours after transfusion; and
(3) A final DBS shall be
collected by the infant’s healthcare provider 60 days after the final
transfusion.
Source. #8529, eff 12-23-05; ss by #9725, eff 7-1-10; ss by #12632, eff
9-28-18; ss by #13530, eff 1-25-23
He-P 3008.06 Disposition of the DBS.
(a) The
DBS shall be processed by the infant’s healthcare provider or designee as
follows:
(1) The infant’s healthcare
provider shall note in the infant’s medical record the date and time the DBS is
obtained;
(2) The filter paper shall be
filled out completely, including the following information:
a. Whether the DBS is an initial or repeat sample;
b. The name of the birth facility where the
infant was born;
c. The infant’s medical record number;
d. The name of the hospital to which the
infant has been transferred, if applicable;
e. The infant’s mother’s name, date of
birth, address, and telephone number;
f. The name, address, and telephone
number of the infant’s healthcare provider;
g. The infant’s first and last name;
h. The infant’s sex;
i. Whether the infant’s birth was a
single birth or multiple birth, and if multiple, the infant’s birth order;
j. The date and time of infant’s birth;
k. The date and time of DBS collection;
l. The infant’s birth weight and current weight;
m. Whether the infant was less than 24 hours old at the time the DBS was
obtained;
n. Whether the infant has undergone
transfusion preceding DBS collection, and, if so, the date of the most recent
transfusion;
o. Whether the infant is a patient in a neonatal intensive care unit or special
care unit;
p. The infant’s feeding method; and
q. Whether the submitter is the birth
facility, the transfer hospital, or the infant’s healthcare provider; and
(3) The filter paper shall be
sent within 24 hours of collection to the laboratory providing analysis of the
DBS via secure courier service provided by the laboratory.
Source. #8529, eff 12-23-05; ss by #9725, eff 7-1-10; ss by #12632, eff
9-28-18; ss by #13530, eff 1-25-23
He-P
3008.07 DBS Analysis. The laboratory conducting
analysis of the DBS shall provide such analysis which includes, but is not
limited to the following disorders:
(a) Phenylketonuria
(PKU);
(b) Maple
syrup urine disease (MSUD);
(c) Homocystinuria
(HCY);
(d) Galactosemia
(GALT);
(e) Congenital
hypothyroidism;
(f) Toxoplasmosis;
(g) Hemoglobinopathies;
(h) Biotinidase deficiency (BIOT);
(i) Congenital adrenal hyperplasia (CAH);
(j) Medium
chain acyl CoA dehydrogenase deficiency (MCAD);
(k) Cystic
fibrosis (CF);
(l) Argininosuccinic aciduria
(ASA);
(m) Argininemia (ARG);
(n) Carnitine
uptake defect (CUD);
(o) Carnitine palmitoyltransferase II deficiency (CPTII);
(p) Citrullinemia
I, (ASA synthetase def) (CIT);
(q) Cobalamin
A,B (Cbl A,B);
(r) Glutaric
aciduria type I (GAI);
(s) 3-hydroxy-3-methylglutaryl-CoA Lysase deficiency (HMG);
(t) Hyperornithinemia hyperammoninemia, homocitrullinemia syndrome
(HHH);
(u) Isovaleric
acidemia (IVA);
(v) Long
chain 3-hydroxyacyl-CoA dehydrogenase deficiency (LCHAD);
(w) 3-Methylcrotonyl-CoA
carboxylase deficiency (3MCC);
(x) Methylmalonic
acidemia (MUT);
(y) Mitochondrial acetoacetyl-CoA thiolase deficiency
(BKT);
(z) Multiple
acyl-CoA dehydrogenase deficiency (GA2);
(aa) Multiple
carboxylase deficiency (MCD);
(ab) Propionic
acidemia (PROP);
(ac) Severe
combined immunodeficiency disorder (SCID);
(ad) Trifunctional
protein deficiency (TFP);
(ae) Tyrosinemia;
(af) Very long chain
acyl-CoA dehydrogenase deficiency (VLCAD);
(ag)
Spinal muscular atrophy (SMA);
(ah)
Mucopolysaccharidosis Type
1 (MPS1);
(ai)
X-Linked Adrenoleukodystrophy (X-ALD); and
(aj) Pompe Disease
(POMPE).
Source. #8529, eff 12-23-05; ss by #8875, eff 4-25-07; ss by #9725, eff 7-1-10;
ss by #12632, eff 9-28-18; ss by #13530, eff 1-25-23
He-P 3008.08 Procedures for Unsatisfactory
and OOR DBS Screening Results.
(a) A
DBS for re-screening shall be collected by the infant’s healthcare provider or
birth facility of record in the following cases:
(1) When an infant’s DBS was
obtained prior to the first 24 hours of life;
(2) When an infant was
transfused before an initial DBS could be collected; or
(3) When the laboratory deems
any specimen as unsatisfactory or any result as OOR.
(b) Upon
notification by the NSP, the infant’s healthcare provider shall:
(1) Arrange for the repeat DBS
collection or additional testing as requested by the NSP; or
(2) Verify that another
provider performs the requested testing.
(c)
Upon request by the NSP, the healthcare
provider shall report via secure means of transmission such as secure fax to 603-271-4519
or secure file transfer protocol, the following information:
(1) Diagnosis and treatment information for
infants whose newborn screening results warranted diagnostic evaluation for a
newborn screening disorder;
(2) Any suspected or confirmed case of a genetic
condition or metabolic disorder listed on the newborn screening panel; and
(3) Any additional, case follow-up information
regarding these diagnoses as requested by the NSP.
(d) If
the infant’s healthcare provider elects to utilize a laboratory service other
than that utilized by the NSP to perform the retesting, the infant’s healthcare
provider shall be responsible for providing the results of this testing to the
NSP.
(e) If
a requested repeat DBS is not received by the NSP within 4 weeks of the notice
in (b) above, the department shall issue a certified letter to the infant’s
healthcare provider and birth facility of record indicating that newborn
screening testing is incomplete.
(f) The
NSP shall cease attempts to obtain the repeat DBS and close its file after
notice in (e) above, indicating the DBS was not received after follow-up.
Source. #8529, eff 12-23-05; ss by #9725, eff 7-1-10; ss by #12632, eff
9-28-18; ss by #13530, eff 1-25-23
He-P
3008.09 Reporting of Results. Upon receipt of a
completed newborn screening report from the department, the birth facility, and
infant’s current healthcare provider shall include a copy of the report in the
infant’s medical record.
Source. #9725, eff 7-1-10; ss by #12632, eff 9-28-18; ss by #13530, eff
1-25-23
He-P
3008.10 Disposal of DBS Residual.
(a) The
testing laboratory shall store DBS specimens in sealed bags of low gas
permeability containing a desiccant and humidity indicator at -20 degrees
Celsius.
(b) The
testing laboratory shall destroy DBS specimens 6 months after the collection
date, in a manner consistent with applicable federal requirements relating to
the disposal of human blood and body fluids per OSHA regulations 29 CFR
1910.1030.
(c) If
the storage environment of any DBS specimen is found to have deviated from the
required conditions described in (a) above, such that the stability of the
specimen is likely to have been affected, the testing laboratory shall first
notify the NSP and shall then destroy the DBS specimen.
Source. #8529, eff 12-23-05; ss by #9725, eff 7-1-10 (from He-P 3008.09);
ss by #12632, eff 9-28-18; ss by #13530, eff 1-25-23
He-P
3008.11 Requests for DBS or Related Records. Residual DBS
specimens and related records may be retrieved for other purposes only with the
written authorization of a parent or guardian.
Source. #8529, eff 12-23-05; ss by #9725, eff 7-1-10 (from He-P 3008.10);
ss by #12632, eff 9-28-18; ss by #13530, eff 1-25-23
He-P
3008.12 Training of Persons Collecting a DBS. All
persons performing DBS collection for newborn screening shall comply with the
proper collection, handling, short-term storage, and transport of DBS in
accordance with the Clinical and Laboratory Standards Institute (CLSI) “NBS 01
Dried Blood Spot Specimen Collection for Newborn Screening, 7th
Edition” (April 2021) available as noted in Appendix A.
Source. #8529, eff 12-23-05; ss by #9725, eff 7-1-10 (from He-P 3008.11);
ss by #12632, eff 9-28-18; ss by #13530, eff 1-25-23
He-P
3008.13 Newborn Screening Advisory Committee.
(a) The commissioner shall
appoint members to a newborn screening advisory committee (NSAC), pursuant to
RSA 132:10-a, III.
(b) The NSAC shall be
comprised of at least one individual from each of the following:
(1) Health
care sub-specialists with expertise relative to newborn screening including,
but not limited to, such specialties as:
a. Endocrinology;
b. Pediatric neurology;
c. Genetics;
d. Hematology;
e. Metabolics;
f. Obstetrics; and
g. Neonatology;
(2) A
member of the health and human services oversight committee, as established by
RSA 126-A:13, appointed by the chair of that committee;
(3) A
genetic counselor;
(4) An
individual with a genetic or metabolic disorder or a parent or caregiver of a
child affected by a genetic or metabolic disorder for which there is a
nationally recommended newborn screening test;
(5) A
midwife practicing outside the hospital setting;
(6) A
representative from the New Hampshire Pediatric Society;
(7) A
nurse with child health experience;
(8) A
representative from the New Hampshire Hospital Association;
(9) A
representative from the department’s public health laboratory;
(10) A
representative from the department’s maternal and child health program;
(11) A
representative from the department’s children with special health care needs
program;
(12) A
representative from the department’s medicaid program;
(13) A
representative from a health insurance provider; and
(14) A
representative from the New Hampshire Academy of Family Physicians.
(c) Additional staff from
the department may participate in the NSAC, but shall not be voting members.
(d) The NSAC shall meet at
least once annually to:
(1) Advise
the department on clinical, educational, and operational aspects of the NSP;
(2) Advise
the department on the inclusion of additional disorders in the current newborn
screening panel based upon the criteria set forth by RSA 132:10-a, I; and
(3) Offer
other advice as requested by the commissioner.
(e) Each member of the NSAC
shall have one vote.
(f) The NSAC shall choose,
by majority vote, 2 new members to serve as co-chairs for a term of 3 years,
including:
(1) One
co-chair employed by the department;
and
(2) One
co-chair not employed by the
department.
(g) A quorum shall consist
of a majority of all voting members.
(h) A quorum shall be
present for a vote to take place.
(i) A
majority vote shall be necessary to pass a motion.
(j) Recommendations by the
NSAC shall be advisory, but not binding.
Source. #8529, eff 12-23-05; ss by #9725, eff 7-1-10 (from He-P 3008.12);
ss by #12632, eff 9-28-18; ss by #13530, eff 1-25-23
He-P
3008.14 Newborn Screening Test Fees.
(a) The
department shall establish fees upon hospitals to be paid directly and entirety
for the newborn screening tests performed.
(b) Fees
for the testing, analysis, and ancillary costs of the newborn screening program
shall be determined by calculating the total yearly costs for program services
divided by the state-wide annual projection of births.
(c) The
department shall re-calculate fee amounts upon commissioner approval of new or
changed newborn screening tests.
(d) Any
change in the fee amount as a result of adding or
changing newborn screening tests shall take effect upon approval by the
commissioner.
(e) The
department shall notify hospitals of any new or increased fee at least 30 days
prior to the fee’s effective date.
Source. #8529, eff 12-23-05; amd by #8875, eff
4-25-07; ss by #9725, eff 7-1-10 (from He-P 3008.13); ss by #12632, eff 9-28-18;
ss by #13530, eff 1-25-23
He-P
3008.15 Reporting of Newborn Hearing Screening Information to
EHDI Program.
(a) Within
2 weeks of testing, individuals conducting newborn hearing screening and
diagnostic hearing evaluation shall report the following information to the
EHDI program via the EHDI database:
(1) Demographic information,
including:
a. The infant’s name;
b. The infant’s sex;
c. The infant’s race;
d. The family of the infant’s
preferred language for communication;
e. The infant’s date of birth;
f. The infant’s medical record
number;
g. The infant’s birth facility;
h. Family contact information; and
i. The infant’s health care provider; and
(2) Results from testing,
including:
a. Birth facility;
b. Testing date;
c. Type of testing;
d. Testing results;
e. Diagnosis; and
f. Risk factors for progressive
hearing loss.
(b) Birth
facilities shall fax to the EHDI program within 48 hours the hearing screening
and diagnostic hearing in (a) above for any infant who does not pass the final
newborn hearing screening.
(c) Newborn
screen and diagnostic hearing information shall be reported via secure means of
transmission such as secure fax to 603-271-4519 or secure file transfer
protocol.
(d) In
addition to the information in (a), above, New Hampshire audiologists providing
diagnostic hearing evaluation shall submit to the department the following
information:
(1) Referral information for
medical, genetic, and early support services; and
(2) Hearing follow-up
information, such as post-referral disposition.
(e) In
addition to the information in (a) above, New Hampshire organizations and
agencies providing intervention and early supports and services to children
between the ages of birth and three years with hearing conditions shall submit
to the department the following information:
(1) Early supports and
services, individual family service plan, start date and discharge date; and
(2) Nature of the services
provided and post referral disposition date.
Source. #8529, eff 12-23-05; ss by #9725, eff 7-1-10 (from He-P 3008.14);
ss by #12632, eff 9-28-18; ss by #13530, eff 1-25-23
He-P
3008.16 Critical Congenital Heart Disease (CCHD) Screening.
(a) Newborn
CCHD screening shall be required for all infants born in the state of New
Hampshire in accordance with RSA 132:10-aa.
(b) CCHD
screening shall be accomplished by pulse oximetry following the American
Academy of Pediatrics (AAP) guidelines and screening algorithm “Strategies for
Implementing Screening for Critical Congenital Heart
Disease,” (November 2011) available as noted in Appendix A.
Source. #8529, eff 12-23-05; ss by #9725, eff 7-1-10 (from He-P 3008.15);
ss by #12632, eff 9-28-18; ss by #13530, eff 1-25-23
He-P
3008.17 Reporting of CCHD Screening Results. Within
24 hours of screening completion, facilities and individuals performing the
screening shall report the results to the NSP, via secure means of transmission
such as secure fax to 603-271-4519 or secure file transfer protocol, the following
demographic information:
(a) The
infant’s name;
(b) The
infant’s sex;
(c) The
infant’s date of birth;
(d) The
infant’s medical record number;
(e) The
infant’s birth facility;
(f) Mother’s
name and address;
(g) Screening
date;
(h) Screening
results following AAP guidelines “Strategies for Implementing Screening for
Critical Congenital Heart Disease,” (November 2011) available as noted in
Appendix A;
(i) Further testing completed for infants with
positive screening results; and
(j) Referral
and transfer information.
Source. #8529, eff 12-23-05; ss by #9725, eff 7-1-10 (from He-P 3008.16);
ss by #12632, eff 9-28-18; ss by #13530, eff 1-25-23
He-P
3008.18 Complaints and Non-Compliance. Upon receiving a
complaint that an individual or facility listed in He-P 3008.02(a)-(f) is not
practicing in accordance with this part, the department shall:
(a) Investigate
the complaint; and
(b) If
founded, refer the complaint to a relevant disciplinary body, such as the New
Hampshire board of medicine.
Source. #8529, eff 12-23-05; ss by #9725, eff 7-1-10 (from He-P 3008.17);
ss by #12632, eff 9-28-18 (formerly He-P 3008.16); ss by #13530, eff 1-25-23
He-P
3008.19 Confidentiality and Security of Records.
(a) All
records maintained by the NSP and EHDI or its contractors, including paper
files, facsimile transmissions, or electronic data transfers, shall be strictly
confidential.
(b) All
confidential information shall be kept in a secured area at
all times as follows:
(1) Paper records and external
electronic storage media shall be kept in locked file cabinets;
(2) All electronic files shall
be password protected; and
(3) All confidential notes or other
materials that do not require storage shall be shredded immediately after use.
Source. #12632, eff 9-28-18 (formerly He-P 3008.17); ss by #13530, eff
1-25-23
He-P
3008.20 Quality Assurance.
(a) Birth
facilities shall allow periodic reviews of their newborn screening, CCHD, and
newborn hearing screening activities by department staff for quality assurance
purposes.
(b) Reviews
shall include, but not be limited to:
(1) The
review of policies and procedures regarding newborn screening, CCHD,
newborn hearing screening, and diagnostic hearing evaluation;
(2) Interviews with staff
performing any aspect of newborn screening, CCHD, and newborn hearing
screening; and
(3) The on-site review of
medical records.
(c) The
NSP shall provide upon request:
(1) Information regarding
acceptable procedures for the collection, handling, short-term storage, and
transport of a DBS;
(2) Information regarding
newborn screening that shall be given to and reviewed with the parent or guardian
of each infant prior to testing; and
(3) Text to be used in
statements of dissent for refusal of newborn screening described in He-P
3008.04(c).
(d) The
NSP and the EHDI program shall compare the data sets of infants screened with
New Hampshire birth certificate files, in order to
ensure that every infant born in New Hampshire is screened, or had the
opportunity to be screened, for hearing, CCHD, and for those conditions that
are determined by DBS testing.
Source. #12632, eff 9-28-18 (formerly He-P 3008.18); ss by #13530, eff
1-25-23
PART He-P 3009 – 3010 – EXPIRED
Source.
#2407, eff 6-30-83, EXPIRED: 6-30-85
PART He-P 3011 BICYCLE PROTECTIVE HEADGEAR REGULATIONS
Statutory Authority – RSA 126-A:5, XIII
He-P
3011.01 Purpose. The purpose of this part is to set forth
rules relative to approved protective headgear as required by RSA 126-A:5,
XIII.
Source. #8524, eff 1-1-06; ss by #10529, eff 2-27-14
He-P
3011.02 Definitions.
(a) “Label” means a sticker with information
identifying the protective headgear as compliant with 16 Code of Federal
Regulations (C.F.R.) Part 1203 by the Consumer Product Safety Commission
(CPSC).
(b) “Protective headgear” means a bicycle helmet
that adheres to the appropriate safety standard set forth in 16 C.F.R. Part
1203 by the CPSC.
Source. #8524, eff 1-1-06; ss by #10529, eff 2-27-14
He-P
3011.03 Safety Standards for
Protective Headgear. All protective
headgear shall have a label as required by the CPSC safety standards.
Source. #8524, eff 1-1-06; ss by #10529, eff 2-27-14
He-P
3011.04 Wear of Protective Headgear. All individuals under the age of 16 shall
wear protective headgear pursuant to RSA 265:144, X.
Source. #8524, eff 1-1-06; ss by #10529, eff 2-27-14
PART He-P
3012 BIRTH CONDITIONS PROGRAM
Statutory
Authority RSA 141-J:9
He-P
3012.01 Purpose. The purpose of this part is to establish the
requirements of a statewide population-based public health surveillance program
on birth conditions. The surveillance
program shall carry out the provisions established in RSA 141-J.
Source. #9404, eff 3-5-09, EXPIRED: 3-5-17
New. #12333,
INTERIM, eff 7-22-17, EXPIRES: 1-18-18; ss by #12448,
eff 1-9-18
He-P
3012.02 Definitions.
(a) “Birth condition” means “birth condition” as
defined in RSA 141-J:2, I namely, “one or more of the birth conditions
recommended by the National Birth Defects Prevention Network and/or the Centers
for Disease Control and Prevention.”
(b) “Commissioner” means the commissioner of the
New Hampshire department of health and human services, or his or her designee.
(c) “Confirmed case” means confirmation by a
medical record abstractor that an individual with a birth condition meets the
criteria for case definition as defined by the National Birth Defects
Prevention Network or Centers for Disease Control and Prevention, or both.
(d) “Department” means the New Hampshire
department of health and human services.
(e) “Facilities” means health care facilities,
clinics, imaging centers, laboratories, medical records departments, and
state offices, agencies, and departments, which have information relating to
the occurrence of birth conditions in children, infants, or stillborn fetuses.
(f) “Health care professional” means a:
(1) Medical
doctor;
(2) Doctor of
osteopathy;
(3) Doctor of
naturopathic medicine;
(4) Advanced
registered nurse practitioner;
(5) Registered
nurse;
(6) Physician’s
assistant;
(7) New
Hampshire certified midwife;
(8) Doctor of
audiology or licensed audiologist; or
(9) Optometrist
or orthopist.
(g) “Health information” means “health
information” as defined in RSA 141-J:2, IV.
(h) “Individually identifiable health
information” means “individually identifiable health information” as defined in
RSA 141-J:2, V.
(i) “Medical records
abstractor” means a staff person from the New Hampshire birth conditions
program, its contractor, or designee who reviews medical information to confirm
the presence of a birth condition.
(j) “New Hampshire birth conditions program
(NHBCP)” means the entity assigned the responsibility for managing the program
pursuant to RSA 141-J under the supervision of the department.
(k) “Opt-out” means the procedure an individual
follows to elect not to participate in the NHBCP program, pursuant to RSA 141-J:5
and RSA 141-J:6.
Source. #9404, eff 3-5-09, EXPIRED: 3-5-17
New. #12333, INTERIM, eff
7-22-17, EXPIRES: 1-18-18; ss by #12448, eff 1-9-18
He-P
3012.03 Program Access to Health
Information.
(a) In accordance with RSA 141-J:3 and this
section, health care providers and facilities shall allow the NHBCP access to
health information and individually identifiable health information relating to
the occurrence of birth conditions in children, infants, and stillborn fetuses.
(b) At least annually, the NHBCP shall direct
health care providers and facilities to generate a list of presumed cases of
birth conditions. This list shall
include only the information allowed by (d)(1) below.
(c) The NHBCP medical records abstractor shall be
allowed to conduct on-site reviews of medical records to determine which cases
identified in (b) above are confirmed cases as recommended by the National
Birth Defects Prevention Network or the Centers for Disease Control and
Prevention or both.
(d) For confirmed cases determined in accordance
with (c) above, the medical records abstractor shall collect:
(1) The diagnosis, the health care provider’s name and
address, and only the following individually identifiable information about the
child, infant, or stillborn fetus:
a. Name; and
b. Address,
including town or city, state, and postal code at the time of birth; and
(2) Additional
non-individually identifiable health information about the child, infant, or
stillborn fetus as recommended by the National Birth Defects Prevention Network
or the Centers for Disease Control and Prevention or both.
(e) If the NHBCP has not received a completed
opt-out form “Birth Conditions Program Registry Form” (12/2017) form from the
individual in accordance with He-P 3012.04, the medical records abstractor
shall return to the health care provider or facility to conduct a second
on-site visit and perform on-site medical record abstraction to collect only
that information described in (f) through (i)
below. This visit shall be conducted no
earlier than 60 days after the opt-out packet was mailed.
(f) For those cases allowed under (e) above, the
following additional individually identifiable health information shall be
collected for the child, infant, or stillborn fetus:
(1) Date of birth
and death, if applicable;
(2) Results of
any genetic testing related to the birth condition; and
(3) Medical
record number.
(g) For those cases allowed under (e) above, the
following individually identifiable information shall be collected for the
mother:
(1) First,
middle, and last name; and
(2) Date of
birth.
(h) For those cases allowed under (e) above, the
following individually identifiable health information shall be collected for the father:
(1) First,
middle, and last name; and
(2) Date of
birth.
(i) If the pregnancy
was voluntarily terminated:
(1) No opt-out
package shall be sent;
(2) No
individually identifiable health information shall be collected; and
(3)
Non-individually identifiable health information may be collected except
that the following shall not be collected:
a. Physician or
other health care provider; and
b. Health care
facility.
(j) The NHBCP shall collect health information
and individually identifiable health
information relating to New
Hampshire residents who meet the criteria for confirmed cases as defined in
He-P 3012.02(c) only from those health care facilities, birth conditions
surveillance programs, or other sources in other states with which the
department has entered into an interstate memorandum of agreement in accordance
with RSA 141-J:3.
(k) The NHBCP shall collect individually
identifiable health information for confirmed cases of birth conditions defined
by He-P 3012.02(c). When a child meets
the criteria for a confirmed case, but a specialist is evaluating the birth
condition further, the program shall maintain the child’s information for up to
2 years while monitoring the outcome of the specialist evaluation. If the
outcome of the specialist evaluation indicates the child no longer meets the
criteria for a confirmed case, all information on the child shall be expunged.
Source. #9404, eff 3-5-09, EXPIRED: 3-5-17
New. #12333, INTERIM, eff
7-22-17, EXPIRES: 1-18-18; ss by #12448, eff 1-9-18
He-P
3012.04 Election Not to Participate
in the NHBCP.
(a) If an individual, or the parent or guardian
of a minor or an individual who is legally
incompetent, objects to the
collection of individually identifiable health information by the NHBCP,
the individual, or a parent or guardian of a minor or an individual who is
legally incompetent, may elect not to participate in the NHBCP program, by
completing and submitting an opt-out form “Birth Conditions Program Registry
Form” (12/2017) , as defined by He-P 3012.03(e) in accordance with RSA 141-J:5
and RSA 141-J:6, I.
(b) Within 7 business days of case confirmation
per He-P 3012.03(d), the NHBCP shall send an opt-out information packet which
shall include:
(1) A letter to
the individual, or the parent or guardian of a minor or an individual who is legally incompetent, explaining
the collection of the birth condition data by the NHBCP under RSA 141:J;
(2) A NHBCP
fact sheet about the nature and purpose of the program including the telephone
number, fax number, mailing address, and email address of the NHBCP;
(3) Information
about state-supported early intervention and prevention services; and
(4) An opt-out
form “Birth Conditions Program Registry Form”
(12/2017) with:
a. A statement
that the failure to complete and return the opt-out form “Birth Conditions
Program Registry Form” (12/2017) within 60 calendar days of the date of the
letter means that their individually identifiable health information as listed
in He-P 3012.03 shall be collected by the NHBCP;
b. A statement
that the individual, or the parent or guardian of a minor or an individual who is legally incompetent, may
elect not to participate at any time in the future in accordance with RSA
141-J:6, I and He-P 3012.06(a);
c. Information
on what will occur as a result of opting out of the
program; and
d. Information
on the possible risks and benefits of participating in the program.
(c) If information packets described in (b) above
are returned to the NHBCP as undeliverable, the program shall contact the individual’s
health care provider for the individual’s most current address. The provider
shall disclose that information solely for the purpose of the NHBCP contacting
the individual regarding the opt-out procedures. Should the information packets described in
(b) above be returned undeliverable a second time, the NHBCP shall not retain
any information other than that allowed by (e) below.
(d) The NHBCP shall send letters to acknowledge
the individual’s decision to opt-out of the NHBCP within 7 business days of
receipt of the completed opt-out form.
(e) The NHBCP shall develop a list of individuals
who have confirmed birth conditions but who have elected to opt-out of the
program, including the dates of such elections, which shall be used only as a
means of verifying that the individual or the parent, or guardian of a minor or
an individual who is legally incompetent, has opted out in the event that
individual’s record is encountered again through routine case finding. This list shall not be disclosed to any
entity or individual outside of the NHBCP and shall be purged after 2 years
from the date the case was confirmed.
Source. #9404, eff 3-5-09, EXPIRED: 3-5-17
New. #12333, INTERIM, eff
7-22-17, EXPIRES: 1-18-18; ss by #12448, eff 1-9-18
He-P
3012.05 Confidentiality and Security
of Records.
(a) All records maintained by the NHBCP,
including paper files, facsimile transmissions, or electronic data transfers,
shall be strictly confidential except as allowed by RSA 91-A.
(b) All confidential information shall be kept in
a secured area or safely stored electronically at all times
as follows:
(1) Paper
records and computer discs shall be kept in locked, cabinets or a medical
record room;
(2) All
individually identifiable health information stored in electronic files shall
be password protected; and
(3) All
confidential notes or other materials entered into the
NHBCP database, which are not required to be stored, shall be shredded
immediately after use.
(c) All staff members of NHBCP and any other
persons given access to individually identifiable health information in the
records maintained by the NHBCP shall sign a confidentiality agreement
specified by the department requiring adherence to this part and the provisions
pursuant to RSA 141-J:8, I.
(d) In accordance with RSA 141-J:8, II, the
department shall maintain a list of any persons other than NHBCP staff given
access to individually identifiable health information.
Source. #9404, eff 3-5-09, EXPIRED: 3-5-17
New. #12333, INTERIM, eff
7-22-17, EXPIRES: 1-18-18; ss by #12448, eff 1-9-18
He-P
3012.06 Rights of Individuals.
(a) Requests to exercise any or all of the rights listed in RSA 141-J:6 shall be put in
writing and sent to:
Department of Health and Human Services
Division of Public Health Services
Maternal and Child Health Section
29 Hazen Dr.
Concord, NH 03301
(b) The department shall respond to those
requests within 10 business days from the receipt of the written request.
Source. #9404, eff 3-5-09, EXPIRED: 3-5-17
New. #12333, INTERIM, eff
7-22-17, EXPIRES: 1-18-18; ss by #12448, eff 1-9-18
He-P
3012.07 Program Ability to Share Data.
(a) Health information, including individually
identifiable health information available to the NHBCP under He-P 3012.03, shall
be used to determine the prevalence and trends of birth conditions, to develop
and assess prevention strategies, and to promote scientific collaboration
through analyses, investigations, and epidemiological studies on the public
health impact and possible causes of birth conditions.
(b) Pursuant to RSA 141-J:3, I, the NHBCP shall
not provide individually identifiable health information relating to New
Hampshire residents to any similar program operated by any other state or the
federal government.
(c) The NHBCP shall maintain the confidentiality
of all individually identifiable health information collected, except as allowed
pursuant to RSA 141-J:4 and RSA 141-J:7 and in accordance with (d) below.
(d) Health information and individually
identifiable health information that is made available to the NHBCP concerning
an individual, and any other information maintained by the NHBCP, which,
because of a personal identifier, can be readily associated with an individual,
shall only be released:
(1) To the
individual upon receipt of:
a. A written
request which shall be signed by the individual;
b. A certified
copy of the birth certificate of the individual; and
c. A copy of
the individual’s identification, such as a driver’s license;
(2) If the individual
is a minor, to a parent of the individual upon receipt of:
a. A written
request, which shall be signed by the parent;
b. A certified
copy of the birth certificate of the individual; and
c. A copy of
the parent’s identification, such as a driver’s license by the parent;
(3) If the
individual has a court-appointed guardian or if the individual is deceased, to
the court-appointed guardian or to the executor or administrator of the
individual’s estate upon receipt of:
a. A written
request, which shall be signed by the court-appointed guardian, executor, or
administrator of the estate;
b. A certified
copy of the order or decree which appoints the guardian, executor, or
administrator; and
c. A copy of
identification, such as a driver’s license, of the guardian, executor, or
administrator;
(4) To an
attorney or other person designated by the individual upon receipt of a written
medical release request which shall be signed by the individual;
(5) Pursuant to
RSA 141-J:7, relative to a legal proceeding upon receipt of a written
authorization from the person about whom the information relates; and
(6) To persons
conducting health related research upon receipt and approval of a written
request to the department pursuant to He-P 3012.08, which shall be signed by
the requestor and include:
a. The
following information about the principal investigator:
1. Name,
address, and phone number;
2.
Organizational affiliation;
3. Professional
qualification; and
4. Name and
phone number of principal investigator’s contact person, if any;
b. The
following information about the data or record copies being requested:
1. Type of
event or record copies;
2. Time period
of the data or record copies;
3. Specific
data items required, if applicable;
4. Medium in
which the data or record copies are to be supplied; and
5. Any special
format or layout of data required by the principal investigator;
c. A research
protocol containing the following:
1. A summary of
the background and origin of the research;
2. A statement
of the health-related problem or issue to be addressed by the research;
3. The primary
research hypothesis to be tested;
4. The research
design, which shall include:
(i) Case definition;
(ii) Method of
case selection; and
(iii) Method of
data analysis;
5. The research
methodology, including:
(i) The way in which the requested data will be
used; and
(ii) The
procedures for follow-back to any persons or facilities named in records, if
applicable;
6. Procedures to
obtain informed consent from the research participants, if applicable;
7. The
procedures that will be followed to maintain the confidentiality and security
of any data or copies of records provided to the requester; and
8. The intended
completion date;
d. A written
statement signed by the principal investigator agreeing to the following:
1. “I am the
person in charge of the health-related research project, as described in the
written request. I am the custodian of
the data responsible for the observance of all conditions of use and for
establishment and maintenance of security arrangements to prevent unauthorized
use of the data and copies of records obtained”;
2. “I
acknowledge that the department is the source of the data in any and all public
reports, publications, or presentations generated by me or the written research
request from this data”;
3. “I acknowledge and specify that the analyses,
conclusions, and recommendations drawn from the data are solely my own or those
developed as part of the health related research and are not necessarily those
of the department”;
4. “I agree that any copies of data or records
provided during the health related research shall not be used for any purpose
other than that described in the written request”;
5. “I shall not disclose the identity of
individuals revealed in the data or record copies to any persons except as is
necessary to perform the research described in the written request”;
6. “I agree to
have a procedure in place to require research staff to agree not to disclose
the identity of individuals revealed in the data or record copies to any
persons except as is necessary to perform the research described in the written
request”;
7. “I agree
that the data record shall not be further released to any other person or
organization without the written consent of and under the terms specified by
the commissioner or his designee”; and
8. “I agree
that no form of information derived from the data or record copies that
identifies any individuals shall be made public.”;
e. A written
statement signed by the principal investigator stating: “I agree to indemnify
the department accepting all responsibility on behalf of the research project
if I or a member of the research staff cause an unauthorized disclosure of individually
identifiable health information”; and
f.
Documentation of Institutional Review Board (IRB) approval for the study
by an IRB formed in accordance with the requirements of the U.S. Department of
Health and Human Services Code of Federal Regulations for Protection of Human
Subjects, 45 CFR 46.
(e) Persons who fraudulently request data shall
be subject to the penalty for unsworn falsifications in accordance with RSA
641:3.
Source. #9404, eff 3-5-09, EXPIRED: 3-5-17
New. #12333, INTERIM, eff
7-22-17, EXPIRES: 1-18-18; ss by #12448, eff 1-9-18
He-P
3012.08 Approval Criteria for Release
of Confidential Data for Research Purposes.
(a) The commissioner shall review and approve
requests for the use of confidential NHBCP data, based on the following
criteria:
(1)
Completeness of written request, pursuant to He-P 3012.07(d)(6);
(2)
Documentation of adequate measures to insure confidentiality of
patients, and security of data pursuant to He-P 3012.07(d)(6);
(3)
Determination of whether the study, if carried out according to the
written request submitted pursuant to He-P
3012.07(d)(6) will be able to answer the research hypothesis as stated in the
written request; and
(4)
Qualifications of principal investigator(s) and research staff, as indicated
by submission of:
a.
Documentation of training and previous research, such as peer reviewed
publications, in the proposed or related area; and
b.
Documentation of an affiliation with a university, medical center or other institution, which will provide sufficient
research resources.
(b) The commissioner shall deny a written request
in accordance with RSA 541-A:29, II(a), when it has been determined that one or
more of the requirements of He-P 3012.07(d)(6) or any of the criteria in
(a) above have not been met.
(c) Upon
approval by the commissioner, the principal investigator or responsible party
shall execute an “NHDHHS Division of Public Health Services Data Use Agreement”
(11/1/17) which describes the permitted uses of the data.
Source. #9404, eff 3-5-09, EXPIRED: 3-5-17
New. #12333, INTERIM, eff
7-22-17, EXPIRES: 1-18-18; ss by #12448, eff 1-9-18
He-P
3012.09 Release of Aggregate Data.
(a) Statistics derived from the NHBCP data shall be considered to be aggregate data if published by towns
with a population of 5,500 or more.
(b) Population estimates shall be derived from
the most recent decennial census.
(c) If there are 4 or fewer confirmed cases in
towns with populations of less than 5,500, then the data at the town level
shall not be released, to prevent constructive identification of individuals.
(d) The age-adjusted rates and age-specific rates
shall:
(1) Not be calculated for cases fewer than 10;
and
(2) Be provided with confidence intervals.
Source. #9404, eff 3-5-09, EXPIRED: 3-5-17
New. #12333, INTERIM, eff
7-22-17, EXPIRES: 1-18-18; ss by #12448, eff 1-9-18
PART He-P
3013 MATERNAL MORTALITY REVIEW PANEL
Statutory
Authority: RSA 132:30, VII
He-P
3013.01 Purpose. The purpose of this part is to establish the
requirements of a maternal mortality review panel in order to
carry out the provisions established in RSA 132:30, VII.
Source. #10287, eff 3-16-13
He-P
3013.02 Definitions.
(a) “Abstraction team” means a team of
professionals designated by the Northern New England Perinatal Quality
Improvement Network (NNEPQIN), which abstracts medical information to review
and analyze the public health implications of a maternal death.
(b) “Commissioner” means the commissioner of the
New Hampshire department of health and human services, or his or her designee.
(c) “Department” means the New Hampshire
department of health and human services.
(d) “Individually identifiable information” means
information relating to the occurrence of a maternal death, as described in RSA
132:31, II.
(e) “Maternal death” means any of the following,
as defined in RSA 132:29, I–III:
(1)
“Pregnancy-associated death” means the death of a woman while pregnant
or within one year of the end of pregnancy, irrespective of cause;
(2) “Pregnancy-associated,
but not pregnancy-related” means the death of a woman while pregnant or within
one year of the end of pregnancy due to a cause unrelated to pregnancy; and
(3)
“Pregnancy-related death” means the death of a woman while pregnant or
within one year of the end of pregnancy, irrespective of the duration and site
of the pregnancy, from any cause related to or aggravated by her pregnancy or
its management, but not from accidental or incidental causes.
(f) “Medical records” means any related
healthcare and mental health record of the mother, including, but not be
limited to, audio and video recordings, vital records, hospital discharge data,
prenatal, fetal, pediatric, or infant medical records, hospital, medical
office, or clinic records, laboratory reports, records of fetal deaths or
induced termination of pregnancies, autopsy reports, and emergency response
records.
(g) “Northern New England Perinatal Quality
Improvement Network (NNEPQIN)” means the entity designated by the department,
through a business associates agreement, to oversee
the review and abstraction of medical information to review and analyze the
public health implications of a maternal death.
(h) “Panel” means the maternal mortality review
panel as established and described in RSA 132:30.
Source. #10287, eff 3-16-13
He-P
3013.03 Identification and Reporting
of Maternal Deaths.
(a)
Facilities, as described in RSA 132:31, II, shall identify and report maternal deaths to
the department.
(b) Maternal deaths may be identified and
reported to the department through the following sources:
(1) Direct
report from a hospital, non-emergency walk-in care center, ambulatory surgical
center, or birthing center;
(2) Data
linkage through a death certificate;
(3) Case
finding from a panel member and reported to the department;
(4) Medical
examiner’s report; and
(5) Other Source.
(c) For maternal deaths identified and reported
in (b)(1) above, the hospital, non-emergency walk-in care center, ambulatory
surgical center, or birthing center shall complete and send a “Maternal
Mortality Initial Report” form (2/2013) to the department either by secure fax,
electronic, or paper format within 10 business days of a maternal death.
(d) Upon receipt of the initial report form in
(c) above, the department shall send the CEO of the hospital or birthing
center:
(1) A “Maternal
Mortality Case Information Sheet” which includes the identified patient’s name
and date of birth; and
(2) A data collection letter which shall include
information on the review process to be conducted by the abstraction team.
(e) For deaths identified in (b)(2)–(5) the
department shall complete the “Maternal Mortality Initial Report” form (2/2013)
and send it and the following to the CEO of the appropriate hospital,
non-emergency walk-in care center, ambulatory surgical center, or birthing
center where the patient received care:
(1) A “Maternal
Mortality Case Information Sheet” which includes the identified patient’s name
and date of birth; and
(2) A data
collection letter which shall include information on the review process to be
conducted by the abstraction team.
(f) Reporting under this part shall not preclude
the requirement for a hospital or ambulatory surgical center to report an
adverse event under RSA 151:37–40 and He-P 802 and He-P 812, respectively, and
for a birthing center to report an unusual incident under He-P 810.
Source. #10287, eff 3-16-13
He-P
3013.04 Program Access to Health
Information.
(a) In accordance with RSA 132:31, II, the
commissioner through NNEPQIN shall have access to individually identifiable
health information relating to the occurrence of a maternal death on a
case-by-case basis where public health is at risk, as follows:
(1) Upon receipt
of the “Maternal Mortality Initial Report” form (2/2013) from the department,
NNEPQIN shall assign an abstraction team to the hospital, non-emergency walk-in
care center, ambulatory surgical center, or birthing center to conduct a review
of medical records within 60 days of receipt of the initial report; and
(2) The
hospital, non-emergency walk-in care center, ambulatory surgical center, or
birthing center shall make available all medical records relating to the
maternal death to NNEPQIN by a secure fax, electronic, or paper method within
60 days of contact by NNEPQIN.
(b) After the completion of the abstraction
process, NNEPQIN shall send the analysis to the department, no later than one
week prior to the semiannual maternal mortality review panel meeting, by
completing and sending the following forms:
(1) “Maternal
Mortality Review Panel Case Abstraction” form (2/2013);
(2) “Maternal
Mortality Review Panel Staffing Questions” form (2/2013); and
(3) “Maternal
Mortality Review Panel Submission Checklist” (2/2013).
Source. #10287, eff 3-16-13
He-P
3013.05 Contact with Families.
(a) The department shall contact families after
the death of the mother to invite them to participate in an interview except
when the department determines such an interview would not assist in the root
cause analysis of a maternal mortality event.
The results and findings of the interview may be included in the case
summary presented to the panel per He-P 3013.06.
(b) Initial family contact shall occur through a
letter from the department to include the following information:
(1) An
invitation for the family to participate in a home interview through a
voluntary process;
(2) The
information obtained shall be used to determine and understand the significant
social, economic, cultural, safety, and health care delivery system factors
that are associated with maternal mortality;
(3) The
information obtained shall be confidential, and the name of the deceased mother
and her family and any other individually identifying information shall not be
released; and
(4) A family
may refuse participation in the home interview
(c) In the event of documented family refusal to
participate, or indication of unwillingness to participate, in an interview,
the department shall not conduct the interview.
Source. #10287, eff 3-16-13
He-P
3013.06 Panel Access to Health
Information.
(a) The department
shall prepare and present to the panel a de-identified case summary of each
maternal death reported or identified based on the following:
(1) NNEPQIN review;
(2) Family interview as applicable; and
(3) The facility’s root cause analysis of the event
if one has been completed.
(c) All members of the panel shall sign a
confidentiality agreement regarding case review conduct and assurances of
confidentiality.
(d) After each case has been reviewed, the
department shall collect all summaries from panel members and shred them
immediately after the meeting.
(e) The panel shall provide the hospital, non-emergency
walk-in care center, ambulatory surgical center, or birthing center a written
copy of the maternal mortality review panel’s general recommendations and
conclusions.
Source. #10287, eff 3-16-13
Appendix
A: Incorporation by Reference Information
Rule |
Title |
Obtain at: |
He-P 3008.12 |
The Clinical and
Laboratory Standards Institute (CLSI), “NBS 01 Dried Blood Specimen
Collection for Newborn Screening, 7th Edition” (April 2021) |
Publisher:
Clinical and Laboratory Standards Institute Cost:
Members $54-$170/Nonmembers $200 The incorporated document
is available at: https://clsi.org/standards/products/newborn-screening/documents/nbs01/ |
He-P 3008.16(b) and
He-P 3008.17(h) |
American
Academy of Pediatrics (AAP), “Strategies
for Implementing Critical Congenital Heart Disease” (November 2011) |
Publisher:
American Academy of Pediatrics (AAP) Cost:
Free of Charge The
incorporated document is available at: |
APPENDIX B
RULE |
STATUTE |
|
|
He-P 3008.01 |
RSA 132:10-a, III; RSA
132:10-b, V |
He-P 3008.02 |
RSA 132:1; RSA 132:10-a |
He-P 3008.03 |
RSA 132:1 |
He-P 3008.04 |
RSA 132:10-a, I;
RSA132:10-c |
He-P 3008.05 |
RSA 132:10-a |
He-P 3008.06 |
RSA 132:10-a |
He-P 3008.07 |
RSA 132:10-a |
He-P 3008.08 |
RSA 132:10-a |
He-P 3008.09 |
RSA 132:10-a |
He-P 3008.10 |
29 CFR 1910.1030 |
He-P 3008.11 |
45 CFR 164.524 |
He-P 3008.12 |
RSA 132:10-a, I(c) |
He-P 3008.13 |
RSA 132:10-a, III |
He-P 3008.14 |
RSA 132:10-a, II; RSA 541-A |
He-P 3008.15 |
RSA 132:10-b, V; RSA 132:12 |
He-P 3008.16 and He-P
3008.17 |
RSA 132:10-aa |
He-P 3008.18 |
RSA 132:3 |
He-P 3008.19 |
45 CFR 160 and 45 CFR 164 |
He-P 3008.20 |
RSA 132:3 |
|
|
He-P 3011.01 - He-P 3011.04 |
RSA 126-A:5; RSA
265:144, X |
|
|
He-P 3012.01 |
RSA 141-J:1; RSA 141-J:9 |
He-P 3012.02 |
RSA 141-J:2; RSA 141-J:9 |
He-P 3012.03 |
RSA 141-J:3; RSA 141:J-5; RSA 141:J-9. |
He-P 3012.04 |
RSA 141-J:5: RSA 141:J-6; RSA 141:J-9. |
He-P 3012.05 |
RSA 141-J:7; RSA 141:J-8; RSA 141:J-9 |
He-P 3012.06 |
RSA 141-J:6; RSA 141:J-9 |
He-P 3012.07 |
RSA 141-J:3; RSA 141:J-4; RSA 141:J-8; RSA 141:J-9. |
He-P 3012.08 |
RSA 141-J:4; RSA 141:J-8; RSA 141:J-9 |
He-P 3012.09 |
RSA 141-J:4; RSA 141:J-8; RSA 141:J-9 |
|
|
He-P 3013.01 |
RSA 132:29-31 |
He-P 3013.02 |
RSA 132:29-31 |
He-P 3013.03 |
RSA 132:31 |
He-P 3013.04 |
RSA 132:30, IV; RSA 132:31 |
He-P 3013.05 |
RSA 132:30, VII(c) |
He-P 3013.06 |
RSA 132:30, VII(d); RSA 132:31 |