DAR File No. 27853

Health, Epidemiology and Laboratory Services, Epidemiology

R386-702-9

Special Measures to Prevent Perinatal and Person-to-Person Transmission of Hepatitis B Infection

NOTICE OF PROPOSED RULE

DAR File No.: 27853
Filed: 05/02/2005, 11:20
Received by: NL

RULE ANALYSIS

Purpose of the rule or reason for the change:

This change is to correct an unintended consequence of a rule amendment that is going into effect at this time.

Summary of the rule or change:

This amendment changes the wording "objects on the basis of religious or moral beliefs" to "...religious or personal beliefs". In the previous amendment, hospitals were required to develop policies to assure that women admitted for delivery or monitoring of pregnancy status were tested for HbsAg before discharge if a test result was not available. In this amendment, those policies will only require that testing prior to discharge be done during admissions for delivery. During admissions for monitoring of pregnancy status, testing prior to discharge will only be required if the women did not have prenatal care prior to the admission. (DAR NOTE: The previous amendment consists of a proposed amendment that was published in the November 1, 2004, Bulletin and the subsequent change in proposed rule (CPR) that was published in the February 1, 2005, Bulletin both under DAR No. 27496. These filings will be effective on 05/16/2005.)

State statutory or constitutional authorization for this rule:

Sections 26-1-30 and 26-6-3

Anticipated cost or savings to:

the state budget:

This rulemaking action requires no additional effort on the state to implement. No additional costs are anticipated.

local governments:

Local governments that operate hospitals may experience some cost savings because unnecessary testing may be avoided.

other persons:

Some reduced costs for hospitals, patients, and third party payers are expected in that unnecessary testing may be avoided.

Compliance costs for affected persons:

This amendment reduces unintended regulatory burden of a previous rule change. No compliance cost is anticipated.

Comments by the department head on the fiscal impact the rule may have on businesses:

These changes respond to public comment and eliminate unnecessary fiscal impact on regulated businesses. David N. Sundwall, MD, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Division of Administrative Rules, or at:

Direct questions regarding this rule to:

Robert Rolfs at the above address, by phone at 801-538-6386, by FAX at 801-538-9923, or by Internet E-mail at rrolfs@utah.gov

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

06/14/2005

This rule may become effective on:

06/15/2005

Authorized by:

David N. Sundwall, Executive Director

RULE TEXT

R386. Health, Community Health Services, Epidemiology.

R386-702. Communicable Disease Rule.

R386-702-9. Special Measures to Prevent Perinatal and Person-to-Person Transmission of Hepatitis B Infection.

(1) A licensed healthcare provider who provides prenatal care shall routinely test each pregnant woman for hepatitis B surface antigen (HBsAg) at an early prenatal care visit. The provisions of this section do not apply if the pregnant woman, after being informed of the possible consequences, objects to the test on the basis of religious or [moral]personal beliefs.

(2) The licensed healthcare provider who provides prenatal care should repeat the HBsAg test during late pregnancy for those women who tested negative for HBsAg during early pregnancy, but who are at high risk based on:

(a) evidence of clinical hepatitis during pregnancy;

(b) injection drug use;

(c) occurrence during pregnancy or a history of a sexually transmitted disease;

(d) occurrence of hepatitis B in a household or close family contact; or

(e) the judgement of the healthcare provider.

(3) In addition to other reporting required by this rule, each positive HBsAg result detected in a pregnant woman shall be reported to the local health department or the Utah Department of Health, as specified in Section 26-6-6. That report shall indicate that the woman was pregnant at time of testing if that information is available to the reporting entity.

(4) A licensed healthcare provider who provides prenatal care shall document a woman's HBsAg test results, or the basis of the objection to the test, in the medical record for that patient.

(5) Every hospital and birthing facility shall develop a policy to assure that:

(a) when a pregnant woman is admitted for delivery, or for monitoring of pregnancy status, the result from a test for HBsAg performed on that woman during that pregnancy is available for review and documented in the hospital record ;

(b) when a pregnant woman is admitted for delivery[, or for monitoring of pregnancy status] if the woman's test result is not available to the hospital or birthing facility, the mother is tested for HBsAg as soon as possible, but before discharge from the hospital or birthing facility;

(c) if a pregnant woman who has not had prenatal care during that pregnancy is admitted for monitoring of pregnancy status only, if the woman's test result is not available to the hospital or birthing facility, the mother is tested for HBsAg status before discharge from the hospital or birthing facility;

(d) positive HBsAg results identified by testing performed or documented during the hospital stay are reported as specified in this rule;

([d]e) infants born to HBsAg positive mothers receive hepatitis B immune globulin (HBIG) and hepatitis B vaccine, administered at separate injection sites, within 12 hours of birth;

([e]f) infants born to mothers whose HBsAg status is unknown receive hepatitis B vaccine within 12 hours of birth, and if the infant is born preterm with birth weight less than 2,000 grams, that infant also receives HBIG within 12 hours; and

([f]g) if at the time of birth the mother's HbsAg status is unknown and the HBsAg test result is later determined to be positive, that infant receives HBIG as soon as possible but within 7 days of birth.

(6) Local health departments shall perform the following activities or assure that they are performed:

(a) Infants born to HBsAg positive mothers complete the hepatitis B vaccine series as specified in Table 3.18, page 328 and Table 3.21, page 333 of the reference listed in subsection (9).

(b) Children born to HBsAg positive mothers are tested for HBsAg and antibody against hepatitis B surface antigen (anti-HBs) at 9 to 15 months of age (3-9 months after the third dose of hepatitis B vaccine) to monitor the success of therapy and identify cases of perinatal hepatitis B infection.

(i) Children who test negative for HBsAg and do not demonstrate serological evidence of immunity against hepatitis B when tested as described in (b) receive additional vaccine doses and are retested as specified on page 332 of the reference listed in subsection (9).

(c) HBsAg positive mothers are advised regarding how to reduce their risk of transmitting hepatitis B to others.

(d) Household members and sex partners of HBsAg positive mothers are evaluated to determine susceptibility to hepatitis B infection and if determined to be susceptible, are offered or advised to obtain vaccination against hepatitis B.

(7) The provisions of subsections (5) and (6) do not apply if the pregnant woman or the child's guardian, after being informed of the possible consequences, objects to any of the required procedures on the basis of religious or moral beliefs. The hospital or birthing facility shall document the basis of the objection.

(8) Prevention of transmission by individuals with chronic hepatitis B infection.

(a) An individual with chronic hepatitis B infection is defined as an individual who is:

(i) HBsAg positive, and total antibody against hepatitis B core antigen (anti-HBc) positive (if done) and IgM anti-HBc negative; or

(ii) HBsAg positive on two tests performed on serum samples obtained at least 6 months apart.

(b) An individual with chronic hepatitis B infection should be advised regarding how to reduce the risk that the individual will transmit hepatitis B to others.

(c) Household members and sex partners of individuals with chronic hepatitis B infection should be evaluated to determine susceptibility to hepatitis B infection and if determined to be susceptible, should be offered or advised to obtain vaccination against Hepatitis B.

(9) The Red Book, 2003 Report of the Committee on Infectious Diseases, as referenced in R386-702-12(4) is the reference source for details regarding implementation of the requirements of this section.

KEY: communicable diseases, rules and procedures

2005

Notice of Continuation August 20, 2002

26-1-30

26-6-3

26-23b

ADDITIONAL INFORMATION

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For questions regarding the content or application of this rule, please contact Robert Rolfs at the above address, by phone at 801-538-6386, by FAX at 801-538-9923, or by Internet E-mail at rrolfs@utah.gov

For questions about the rulemaking process, please contact the Division of Administrative Rules (801-538-3764). Please Note: The Division of Administrative Rules is NOT able to answer questions about the content or application of these administrative rules.