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 DISORDER 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

 

          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 disorder screening;

 

          (d)  Providers, certified midwives, and nurse midwives performing newborn dried blood spot screening, newborn hearing screening, and critical congenital heart disorder screening;

 

          (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

 

          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 Disorder (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)  “Infant’s healthcare provider” means the licensed medical doctor, licensed doctor of osteopathy, licensed advanced practice nurse, licensed physician’s assistant, or certified midwife,  responsible for the care of the newly born infant.

 

          (k)  “Informed dissent” means the written refusal by an infant’s parent or guardian to participate in newborn screening as defined in this rule.

 

          (l)  “Laboratory” means the testing facility authorized by the State of New Hampshire to conduct DBS testing on its behalf.

 

          (m)  “Newborn hearing screening” means evaluating the hearing status of infants.

 

          (n)  “Newborn screening” means the DBS testing of infants.

 

          (o)  “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.

 

          (p)  “Out of range (OOR) result” means a DBS test result that is inconclusive.

 

          (q)  “Pediatric audiologist” means a person who specializes in the assessment and rehabilitation of hearing loss in infants and children.

 

          (r)  “Unsatisfactory specimen” means a DBS specimen which is unacceptable for testing.

 

Source.  #8529, eff 12-23-05; ss by #9725, eff 7-1-10; ss by #12632, eff 9-28-18

 

          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 informed dissent to the infant’s healthcare provider or designee, subject to the following:

 

(1)  A statement of dissent for testing shall be signed and dated by the infant’s parent or guardian;

 

(2)  The statement of dissent 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 to the NSP; and

 

(4)  A copy of the statement of dissent 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)-(i) 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

 

          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)  When the infant’s birth weight is less than 1500 grams, the infant’s healthcare provider or designee shall obtain additional DBS for repeat testing at 2, 6, and 10 weeks of age, and monthly thereafter, until the infant reaches 1500 grams  body weight.

          (e)  For infants who are sick, premature, or in an intensive care unit, the infant’s healthcare provider or designee shall obtain:

 

(1)  An initial DBS between 24 and 48 hours of the infant’s life; and

 

(2)  A second DBS at 2 weeks of age or at birth facility discharge, whichever is earlier.

 

          (f)  Except as allowed by (g) below, the infant’s healthcare provider shall ensure that a DBS is obtained prior to transfer to another medical facility.

 

          (g)  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.

 

          (h)  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.

 

          (i)  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

 

          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/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.

 

          (b)  The DBS shall be transported to the laboratory by:

 

(1)  Courier service provided by the laboratory, or

 

(2)  Posted by overnight mail, in accordance with U.S. Postal Service regulations, within 24 hours of collection.

 

Source.  #8529, eff 12-23-05; ss by #9725, eff 7-1-10; ss by #12632, eff 9-28-18

 

          He-P 3008.07  DBS Analysis.  The laboratory conducting analysis of the DBS shall provide such analysis with respect 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; and

 

          (af)  Very long chain acyl-CoA dehydrogenase deficiency (VLCAD).

 

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

 

          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)  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.  

 

          (d)  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.

 

          (e)  The NSP shall cease attempts to obtain the repeat DBS and close its file 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

 

          He-P 3008.09  Reporting of Results.  Upon receipt of a completed newborn screening report from the department, the birth facility 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

 

          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

 

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

 

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-A6, Blood Collection on Filter Paper for Newborn Screening Programs, Approved Standard-Sixth Edition,” (July 2013) 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

 

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)  A parent of a child affected by a 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 Chapter of the March of Dimes;

 

(9)  A representative from the New Hampshire Hospital Association;

 

(10)  A representative from the department’s public health laboratory;

 

(11)  The department’s medical director or designee;

 

(12)  A representative from the department’s maternal and child health program;

 

(13)  A representative from the department’s children with special health care needs program;

 

(14)  A representative from the department’s medicaid program;

 

(15)  A representative from a health insurance provider; and

 

(16)  A representative from the New Hampshire Academy of Family Practitioners.

 

(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 members to serve as co-chairs, 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

 

He-P 3008.14  Newborn Screening Test Fees.

 

(a)  The department shall establish and impose fees upon hospitals 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

 

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 faxed via secure fax line at 603 271 4519.

 

(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 3 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

 

          He-P 3008.16  Critical Congenital Heart Disorder (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

 

          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 fax line at 603 271 4519 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

 

He-P 3008.18  Complaints and Non-Compliance. Upon receiving a complaint that an individual or facility listed in He-P 3008.02(a)-(e) 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)

 

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)

 

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 informed dissent.

 

(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)

 

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

NBS 01-A6

“Blood Collection on Filter Paper for Newborn Screening Programs; Approved Standard” – Sixth Edition

(July 2013)

Available Clinical and Laboratory Standards Institute (CLSI)

950 West Valley Road, Suite 2500, Wayne, PA 19087 at a cost of $140.

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)

Available free of charge from the American Academy of Pediatrics website at www.pediatrics.aapublications.org/content/128/5/e1259.

 

 

 

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 164.524

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