No. 27496 (Amendment): R386-702. Communicable Disease Rule

DAR File No.: 27496
Filed: 10/15/2004, 03:07
Received by: NL

 

RULE ANALYSIS

Purpose of the rule or reason for the change:

This amendment is intended to prevent perinatal transmission and transmission to household and close family contacts of hepatitis B.

 

Summary of the rule or change:

The amendments are: 1) requiring testing for hepatitis B surface antigen (HBsAg) during prenatal care and documentation of results in the provider record; 2) requiring that hospitals and birthing facilities develop policies to prevent transmission. Those policies should assure that women have been tested, that positive results are reported to public health (required in current rule), and that infants born to infected mothers are treated appropriately; 3) directing local health departments to provide case management for babies born to HBsAg positive mothers, and case management for persons with chronic HBsAg infection; and 4) requiring that pregnancy status be reported with HBsAg positive results in pregnant women when that information is available to the reporting entity.

 

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.

 

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 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. Scott D. Williams, MD

 

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

Health
Epidemiology and Laboratory Services, Epidemiology
CANNON HEALTH BLDG
288 N 1460 W
SALT LAKE CITY UT 84116-3231

 

Direct questions regarding this rule to:

Robert Rolfs at the above address, by phone at 801-538-6386, by FAX at 801-538-6694, or by Internet E-mail at [e-mail]

 

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:

12/01/2004

 

This rule may become effective on:

12/02/2004

 

Authorized by:

Scott D. Williams, 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.

(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) 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 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 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) if the woman's test result is not available, the mother is tested for HBsAg as soon as possible, but before discharge from the hospital;

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

(c) 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) infants born to mothers whose HBsAg status is unknown receive hepatitis B vaccine within 12 hours of birth, 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).

(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).

(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).

(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) 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) 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.

 

R386-702-10. Public Health Emergency.

(1) Declaration of Emergency: With the Governor's and Executive Director's or in the absence of the Executive Director, his designee's, concurrence, the Department or a local health department may declare a public health emergency by issuing an order mandating reporting emergency illnesses or health conditions specified in sections R386-702-3 for a reasonable time.

(2) For purposes of an order issued under this section and for the duration of the public health emergency, the following definitions apply.

(a) "emergency center" means:

(i) a health care facility licensed under the provisions of Title 26, Chapter 21, Utah Code, that operates an emergency department; or

(ii) a clinic that provides emergency or urgent health care to an average of 20 or more persons daily;

(b) "encounter" means an instance of an individual presenting at the emergency center who satisfies the criteria in section R386-702-3(2); and

(c) "diagnostic information" means an emergency center's records of individuals who present for emergency or urgent treatment, including the reason for the visit, chief complaint, results of diagnostic tests, presenting diagnosis, and final diagnosis, including diagnostic codes.

(3) Reporting Encounters: The Department shall designate the fewest number of emergency centers as is practicable to obtain the necessary data to respond to the emergency.

(a) Designated emergency centers shall report using the process described in R386-702-4.

(b) An emergency center designated by the Department shall report the encounters to the Department by:

(i) allowing Department representatives or agents, including local health department representatives, to review its diagnostic information to identify encounters during the previous day; or

(ii) reviewing its diagnostic information on encounters during the previous day and reporting all encounters by 9:00 a.m. the following day, or

(iii) identifying encounters and submitting that information electronically to the Department, using a computerized analysis method, and reporting mechanism and schedule approved by the Department; or

(iv) by other arrangement approved by the Department.

(4) For purposes of epidemiological and statistical analysis, the emergency center shall report on encounters during the public health emergency that do not meet the definition for a reportable emergency illness or health condition. The report shall be made using the process described in 702-9(3)(b) and shall include the following information for each such encounter:

(a) facility name;

(b) date of visit;

(c) time of visit;

(d) patient's age

(e) patient's sex

(f) patient's zip code for patient's residence;

(5) If either the Department or a local health department collects identifying health information on an individual who is the subject of a report made mandatory under this section, it shall destroy that identifying information upon the earlier of its determination that the information is no longer necessary to carry out an investigation under this section or 180 days after the information was collected. However, the Department and local health departments shall retain identifiable information gathered under other sections of this rule or other legal authority.

(6) Reporting on encounters during the public health emergency does not relieve a reporting entity of its responsibility to report under other sections of this rule or other legal authority.

 

R386-702-1[0]1. Penalties.

Any person who violates any provision of R386-702 may be assessed a penalty not to exceed the sum of $5,000 or be punished for violation of a class B misdemeanor for the first violation and for any subsequent similar violation within two years for violation of a class A misdemeanor as provided in Section 26-23-6.

 

R386-702-1[1]2. Official References.

All treatment and management of individuals and animals who have or are suspected of having a communicable or infectious disease that must be reported pursuant to this rule shall comply with the following documents, which are adopted and incorporated by reference:

(1) American Public Health Association. "Control of Communicable Diseases Manual". 17th ed., Chin, James, editor, 2000.

(2) Centers for Disease Control and Prevention. Recommendation of the Immunization Practices Advisory Committee (ACIP): Human rabies Prevention - United States, 1999. "Morbidity and Mortality Weekly Report." 1999; 48: RR-1, 1-21.

(3) The National Association of State Public Health Veterinarians, Inc., "Compendium of Animal Rabies Prevention and Control, 2004, Part II."

(4) American Academy of Pediatrics. "Red Book: 2003 Report of the Committee on Infectious Diseases" 26th Edition. Elk Grove Village, IL, American Academy of Pediatrics; 2003.

 

KEY: communicable diseases, rules and procedures

[June 11, ]2004

Notice of Continuation August 20, 2002

26-1-30

26-6-3

26-23b