DAR File No. 27496

Health, Epidemiology and Laboratory Services, Epidemiology

R386-702

Communicable Disease Rule

NOTICE OF CHANGE IN PROPOSED RULE

DAR File No.: 27496
Filed: 01/12/2005, 10:46
Received by: NL

RULE ANALYSIS

Purpose of the rule or reason for the change:

Public comments led to these changes.

Summary of the rule or change:

The option for parents to object to testing and vaccination was added. Occurrence of hepatitis B in the household or close family contact was added as a risk factor for testing. Organization of the rule was altered to improve readability. (DAR NOTE: This change in proposed rule has been filed to make additional changes to a proposed amendment that was published in the November 1, 2004, issue of the Utah State Bulletin, on page 13. Underlining in the rule below indicates text that has been added since the publication of the proposed rule mentioned above; strike-out indicates text that has been deleted. You must view the change in proposed rule and the proposed amendment together to understand all of the changes that will be enforceable should the agency make this rule effective.)

State statutory or constitutional authorization for this rule:

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

Anticipated cost or savings to:

the state budget:

The activities required under these amendments can be handled under existing communicable disease and immunizations programs in the Department of Health. No additional costs are anticipated.

local governments:

These activities are currently performed by local health departments and additional costs, if any, should be minimal.

other persons:

The clinical activities required in these amendments are currently standard of practice and should result in minimal increased costs. There will be some costs to implement policies in facilities where such policies do not yet exist. These costs will be transient and minimal but are not easily quantified. Laboratories that implement collection of pregnancy status might incur costs for changes in forms or data submission systems, but the rule is permissive allowing these to occur as systems are upgraded. By expressly allowing parents the option to object to testing or vaccination, facilities will not be caught between a rule mandate and the wishes of the parent. This may avoid some administrative and legal costs.

Compliance costs for affected persons:

Doctors, hospitals, and local health departments indicate that the activities required are standard of practice. Thus, these changes should result in few if any costs not now being experienced. If these rule changes result in hepatitis B surface antigen (HBsAg) testing of persons who would otherwise not have been tested, despite it being the standard of practice, either that person's insurance plan or the individual might incur a cost of $10 - $15 for hepatitis B testing.

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

Preventing perinatal transmission and transmission to household and close family contacts of hepatitis B is a critical public health mandate. This rule will impose minimal cost on the health care industry, since this practice is already the standard of care. David N. Sundwall, MD, Acting 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:

03/03/2005

This rule may become effective on:

03/04/2005

Authorized by:

Richard Melton, Deputy 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 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;[or]

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

([d]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 [when]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,[

(i) ] the result from a test for HBsAg performed on that woman during that pregnancy is available for review and documented in the hospital record[, or] ;

[(ii)](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;

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

([c]d) 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;

([d]e) 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

[ (i) if the mother's HBsAg test result is positive, that infant should receive HBIG as soon as possible but within 7 days of birth; and

(ii) if the infant was born preterm with birth weight less than 2,000 grams, that infant should receive HBIG within 12 hours of birth as specified on page 333 of the reference listed in (8).

] (f) 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 [(8)]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 [(8)]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.

([7]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.

([8]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

[2004]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.