Health Codes for Newborn Care

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VOLUME 80 . JULY 1987 . NUMBER 1

Pec

Ics

Health

Codes

for Newborn

Care

Salvatore J. Caravella, MD, David A. Clark, MD, and

Harry S. Dweck, MD

From the Division of Neonatal-Perinatal Medicine, Department of Pediatrics, New York Medical College, Westchester Medical Center, Valhalla

ABSTRACT. A survey was conducted of the health

de-partments in each ofthe 50 states, Washington, DC, and

the Commonwealth of Puerto Rico to determine the present legal mandates for newborn care. Each of the 52 health departments were queried regarding birth certifi-cates, identification procedures, prophylactic eye care, umbilical cord care, use of vitamin K, Apgar scoring, and metabolic screening. In each category, the departments were asked whether the procedures were mandatory or optional. Birth certificates are uniformly required within the health codes of all states. Although in-hospital iden-tification of newborns is required in most states, four states specifically require arm banding, and only New York State requires footprinting. Eye prophylaxis with silver nitrate is required in 49 states, with erythromycin or tetracycline allowed as topical alternatives in 42 states. Clamping of the umbilical cord is addressed by eight states. Parenteral vitamin K administration is mandated by only five states. Apgar scoring is addressed by 25 states. Newborn metabolic screening is available in every

health department, although significant variations exist in the tests available. Pediatrics 1987;80:1-5; eye

prophy-laxis, metabolic screening, newborn care, vitamin K.

The

Guidelines for Perinatal Care,hPhu of the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists, provide

specific recommendations for the general care of all

Received for publication Aug 27, 1986; accepted Oct 20, 1986.

Presented, in part, at the American Pediatric Society-Society for Pediatric Research meeting, Washington, DC, May 1986. Reprint requests to (S.J.C.) Westchester Medical Center, Re-gional Neonatal Intensive Care Unit, Valhalla, NY 10595.

newborns. The guidelines are not “a body of rigid

rulesht)hh but are general and serve as a basis from

which codes and regulations can be devised.)u1

Many innovations in neonatal-perinatal

medi-cine have transpired since the publication of the guidelines. With medical liability creating cautious and defensive pediatric practice,2 newborn health codes should legally support the standards for health care that physicians deliver.

The purpose of this study was to establish and report a detailed summary of the present legal mandates assuring the quality of newborn care.

MATERIALS AND METHODS

The practices considered were the standards of general newborn care that are routine and

custom-ary in the United States. Evaluation was done by questionnaire to each of 52 health departments of the 50 states, the District of Columbia, and the Commonwealth of Puerto Rico.

Health departments that did not respond were

sent a follow-up questionnaire 3 to 4 months later. When responses required clarification, the respon-sible individual in each health department was con-tacted by telephone.

The questionnaire focused on three general areas of newborn care: infant identification (birth certif-icates, footprinting, arm banding practices), pro-phylactic newborn care (prophylactic eye care, care of the umbilical cord including clamping and topical antiseptics, administration ofvitamin K), and eva!-uation of the newborn (Apgar scoring, screening procedures for metabolic and other disorders).

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iden-tify the statutes and regulations regarding each of

these areas of newborn care, report whether the

procedures were mandatory or optional, and supply a copy of the specific laws and regulations.

RESULTS

Compliance/Concordance

Thirty-seven health departments fully answered

the questionnaire on the first mailing with an

ad-ditional six by the second mailing. The remaining

nine required direct telephone contact to ensure

completion of the questionnaire.

Inconsistencies were discovered among 34 of the

52 returned questionnaires and the accompanying copies of statutes and regulations. Direct telephone

confirmation was made for clarification of these

incompatibilities.

Infant Identification

Birth certificates are required by every health

department surveyed. Many states report that the

source used for revising and updating required data is the standard birth certificate of the National Center for Health Statistics.t

Of the 52 health departments, only 19 states

mandate identification of newborns in a hospital

setting. Fifteen health departments do not specify the type of identification required. Four states

(Ar-kansas, New Jersey, New York, and Ohio) specify

arm banding. New York is the only state that

requires footprinting.

Prophylactic Newborn Care

Topical prophylaxis against gonococcal

ophthal-mia neonatorum is required by law in 49 of 52

health departments surveyed. Prophylactic eye care is not addressed in the health codes of Nebraska, North Dakota, and Vermont, although it was re-ported that it is widely practiced in these states.

Eight departments provide for parental refusal of

prophylaxis (three based on religion and five based on personal beliefs).

Forty-two of the health departments allow for

erythromycin or tetracycline as alternatives to sil-ver nitrate. Five of the 42 permit any proven effec-tive prophylaxis. Mississippi allows only

erythro-mycin, and Pennsylvania allows only tetracycline as alternatives. In the states of Alaska and

Mary-land, topical eye prophylaxis is waived when

par-enteral antibiotics are given. The specified interval

of time for prophylaxis varies from immediately to

three hours after birth.

Several states, in an attempt to avoid code revi-sions by legislative action, require that all current

recommendations and future revisions should

re-flect those provided by the Centers for Disease

Control.

Eight states address clamping of the umbilical

cord. Five (Georgia, Massachusetts, New Jersey,

Pennsylvania, and South Carolina) specify that the

cord must be clamped, although the technique and

timing are not addressed. The remaining three

(Michigan, Nebraska and Utah) simply state that

equipment required for cord clamping must be

available in the delivery room. Topical care of the umbilical cord is not addressed by any health code. The administration of parenteral vitamin K as

prophylaxis against hemorrhagic disease of the

newborn is required by five health departments

(Georgia, Illinois, Maryland, Oregon, and

Wyo-ming). Only one state, Oregon, allows administra-tion of vitamin K orally, as an acceptable alterna-tive.

Evaluation of the Newborn

Although the Apgar score4’#{176}is an established

standard of newborn assessment, only six states

specifically require its use. Nineteen states report inclusion of the score in the “medical and health use” section of the birth certificate but not within the mandatory health codes.

Metabolic screening programs are available in

every state and territory. Participation is manda-tory in all but six states. However, 29 of the 46

health departments that mandate participation

provide for parental refusal (17 based on religion and 12 based on personal beliefs).

Thirty-five health departments enumerate the

specific diseases tested for in their newborn meta-bolic screening program. Alternatively, 11 health departments specify testing for phenylketonuria

and “other forms of preventable mental

retarda-tion.” In the latter group of states, agencies exist to promulgate regulations to modify the screening pro-grams without additional legislative approval.

Screening for phenylketonuria is the only meta-bolic test uniformly available in all 50 states,

Wash-ington, DC, and Puerto Rico. The number of health

departments that provide screening tests for other

metabolic diseases include: galactosemia (34

states), maple syrup urine disease (19 states), hom-ocysteinuria (14 states), tyrosinemia (four states) hypermethioninemia (three states) ,

hyperleucine-mia (2 states), histidinemia (one state), and aden-osine deaminase deficiency (one state). The follow-ing nonmetabolic screening tests are also available: congenital hypothyroidism (50 states),

hemoglobi-nopathies (11 states), and hearing risk registry

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poi-soning in Missouri, screening for cystic fibrosis in

Wisconsin, and screening for congenital adrenal

hyperplasia in Washington State. Testing for

tub-erous sclerosis was previously required in Massa-chusetts but has been rescinded because of its Un-reliability. Presently, legislation is being considered

to remove histidinemia and adenosine deaminase

deficiency from the New York State screening

pro-gram because these tests are not cost effective. No

health department offers all of the above cited

screening tests in one metabolic screening program.

DISCUSSION

Infant Identification

Since 1900, the standard for birth certificates has

been provided by the National Center for Health

Statistics.t It is revised periodically and, as of 1984, will be revised every 4 years. Even with revisions,

completeness and accuracy are persistent

prob-lemst,t Simplification of birth certificate design

facilitates reporting of data. When Washington

State changed from the “open-ended” format to the

“check-box” format in 1980, completeness and

ac-curacy increased from less than 50% to greater than

8O%. Despite

this

finding, in 1982, 87% of health

departments were still using the open-ended

de-sign.t A health official in Alaska reported a dra-matic increase in the registering of newborns after a yearly cash award for each registered resident was instituted.

Hospital identification by arm banding is an easy

and reliable method of identifying newborns and is

supported by the American Academy of Pediatrics

and the American College of Obstetricians and

1 I p75)

If footprinting were appropriately performed, it

would be a reliable form of identification7’8; how-ever, as many as 89% of footprints are unidentifi-able because of unsatisfactory technique.9”#{176} The

practice is no longer recommended because of its

unreliability and lack of cost effectiveness.’78t

Prophylactic Newborn Care

Prophylaxis against gonococcal ophthalmia has

been widely practiced since Cred#{233}’soriginal report

in 1881.h113 Of all the children in institutions for

the blind at the time, an estimated 20% to 79% of

the children were blind because of gonococcal

12

Controversy about the use of silver nitrate for

prophylaxisLtS has focused on the lack of complete effectiveness against Neisseria gonorrhea’ (p262), 13,15,16

or Chiamydia trachomatis’2633’52’ and also the high incidence (up to 90%22) of chemical conjunc-tivitis associated with silver nitrate.

The Centers for Disease Control currently rec-ommend the choice of instilling 1% silver nitrate

solution, 1% tetracycline ointment (or drops), or

0.5% erythromycin ointment (or drops) into the

eyes of all newborns within one hour after

birth’26”,2’,24 This has been endorsed by the

American Academy of Pediatrics, American College

of Obstetricians and Gynecologists, and the

Na-tional Society to Prevent Blindness Committee on

Ophthalmia Neonatorum.

In countries where the incidence of gonorrhea is

low or when prenatal diagnosis and treatment

places the infant at low risk,’t”4,’7 the necessity for

prophylaxis has been questioned. In the United

States, however, the recent increase in gonococcal

disease and the emergence of resistant strains’6

justifies the present recommendation.

Clamping of the umbilical cord is addressed by

only seven health departments, but no method is

specified. In a healthy term infant the incidence of

bleeding without clamping is less than 1% if the

cord is allowed to stop pulsating prior to cutting.25 Timing of cord clamping is controversial because it is unclear whether a transfusion of placental blood is advantageous.26

In the Guidelines for Perinatal Care, it is stated

that “no single method of cord care has proven

superior in preventing colonization and

dis-ease.””’’20t The most commonly used topical agents are alcohol, triple dye, and bacitracin. Although reduction of colonization has been demonstrated with each of these agents,2729 no single superior

topical agent has been established. Perhaps, appro-priately, no state addresses topical cord care.

Hemorrhagic disease of the newborn was first described by Townsend in 1894.t0 The relationship of vitamin K deficiency to this disease was

estab-lished in the 19305.30 In the 1950s and 1960s, an

estimated 1% to 2% of breast-fed infants

mani-fested the disease by the second or third day of

life.” By 1962, Welfring’2 reported that the admin-istration of oral or parenteral preparations of

vita-mm K improved vitamin K-dependent coagulation

factors. Recently, O’Connor and Addiego33

demon-strated that oral administration of vitamin K is as effective as IM administration.

The reported incidence of hemorrhagic disease of

the newborn without vitamin K prophylaxis is one

in 200 to one in 400. Recent cases of hemorrhagic

disease of the newborn have been reported in

in-fants who have been primarily breast-fed and have

not received prophylaxis.354#{176} Even with the admin-istration of vitamin K, there are still infants at risk

for hemorrhagic disease of the newborn. These

include infants with prenatal exposure to

anticon-vulsants, rifampin or isoniazid, liver disease, and

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in-fants are potentially at risk because human milk has little vitamin K.

The Committee on Nutrition of the Academy of

Pediatrics recommends the administration of 0.5 to

1.0 mg of parenteral vitamin K, oxide (phytona-dione) within one hour after birth.’’5t’42

Only five of the 52 health departments mandate

the use of vitamin K prophylaxis, even though

prophylaxis is widely practiced. Without legal man-date, parents have the right to refuse the adminis-tration ofvitamin K. Parents who refuse parenteral vitamin K prophylaxis should be offered an alter-native of oral prophylaxis rather than no prophy-laxis.

Health departments should be aware of the

pos-sible legal ramifications produced by not addressing vitamin K prophylaxis in their health code.

Evaluation of the Newborn

Apgar scoring is recommended for the evaluation of the newborn.’#{176}#{176}Soon after its introduction in

i953, it became the standard for the immediate assessment of the newborn infant. It is useful in

helping to identify the depressed infant who may

require some form of resuscitation.

The Apgar score was incorporated into the stan-dard national birth certificate in 1978.’ As of 1986,

only 25 health departments have regulations

en-couraging Apgar scoring. Despite its potential

lim-itations,4’t4 we recommend that the Apgar score be

included as part of newborn care, until a better

rapid assessment technique is developed.

Newborn-screening programs have been

recom-mended for all newborns.4t “ Every state provides for metabolic screening; however, there is wide

var-iability not only in the diseases screened but in

provision for parental consent or refusal, genetic

counseling, and professional and public

educa-tion.52St Even if an exact program is outlined in the health care code, lack of funding may prohibit full implementation. Variability in neonatal screening programs is also based on cost effectiveness. “The

differences between the jurisdictions exceed the

similarities and serve to underscore the complexity

of the many unresolved issues which are central to

the development of screening programs and

poli-cies.”5’

Metabolic screening programs of individual

health departments may be based on local and

regional incidence- and prevalence-specific disor-ders as well as specific available resources.

The difference in availability of screening tests from state to state may generate confusion,

contro-versy, and medical liability for the practicing phy-sician. The Task Force on Medical Liability of the

American Academy of Pediatrics2 has reported that

newborn screening has become routine throughout the

country for certain metabolic and endocrine causes of

mental retardation.

..

. Failure to detect one of these disorders because of omission may be considered

negli-gent.

The Task Force also stated that2

it was formerly held by most jurisdictions that a

pedia-trician could be held accountable only for the standard

of care in the community where the practice was located. Now, however, pediatricians will be held to a level of

competency thought to he universal among pediatricians in the United States.

Hearing-risk screening5 is important, especially

for graduates of newborn intensive care units, be-cause in this population, the reported incidence of

hearing impairment is “Thirty-nine

per-cent of closed claims involved errors in diagnosis,

delay in diagnosis, and failure to diagnose.”2 At

least 5% of these “involved premature or newborn infants,” and the largest claims were in the category of “blindness” and “impairment of hearing.”2

Recommendations

1. The Guidelines for Perinatal Care is the

refer-ence of choice for standards of newborn care. It

should not be viewed as a body of rigid rules that

impedes the implementation of appropriate

ad-vances in newborn care.

2. The standards of’ newborn care should be cre-ated by the medical community and communicated to the responsible governmental agencies.

3. Physicians responsible for newborns must ac-tively participate with the appropriate and respon-sible governmental authorities to implement appro-priate standards to assure quality newborn care.

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1987;80;1

Pediatrics

Salvatore J. Caravella, David A. Clark and Harry S. Dweck