Laboratory Reporting of Pregnancy Status for Hepatitis B-positive Women

How can I help stop the spread of hepatitis B virus from mother to child?

Role of Laboratories

Laboratories interested in joining this effort can take the following action steps:

1. Identify Pregnancy Status
   • Clearly indicate pregnancy status when available on all HBsAg-positive test results reported to health departments and ordering clinicians.  These test results include, but are not limited to, the following:
     • Orders originating as obstetric (“OB”) panels or prenatal screening panels that include HBsAg testing as a component
     • Individual HBsAg test orders originating from an OB or prenatal panel performed elsewhere (HBsAg outsourced to a reference lab)  
     • Orders originating as an individual prenatal HBsAg test
     • Orders for a standalone HBsAg test that is not part of an OB or prenatal panel but where pregnancy status is indicated elsewhere on the order (e.g. as a pregnancy-related ICD-9/10 diagnosis code; examples can be found in this file [EXCEL - 33KB].)

2. Client Education
   • Educate clinicians about laboratory testing options for selecting an OB or prenatal panel when screening pregnant women for HBsAg.
   • Encourage clinicians to identify pregnant women when ordering HBsAg tests as a standalone or part of a non-OB/non-prenatal panel. For example, have clinicians provide ICD-9/10 diagnosis codes indicating pregnancy and include these codes in positive reports sent to health departments. 

3. Reporting & Testing
   • Provide timely reports of all HBsAg-positive test results to appropriate health departments. Labs are also encouraged to provide positive test results of known pregnant women directly to local Perinatal Hepatitis B Prevention Programs as feasible.
   • Perform licensed neutralizing confirmatory testing on all HBsAg tests included in OB and prenatal panels or when the ICD-9/10 diagnosis code indicates pregnancy.
   • Include verification of confirmed HBsAg-positive results on the final lab report, if assay is performed on a pregnant woman.

For assistance in establishing a method of identifying HBsAg-positive pregnant women or for any additional questions: Please contact dvhwi@cdc.gov.

Role of Clinicians and Health Departments

Clinicians and Health Departments also play a critical role in laboratory reporting of pregnancy status for Hepatitis B-positive women.

Clinicians:

• Select a test designated as “prenatal” or on a prenatal/obstetric panel when ordering an HBsAg screening test for a pregnant woman to help ensure confirmatory testing is performed on all positive HBsAg screens.  
• Inform selected laboratory of a woman’s pregnancy status to ensure confirmatory testing is performed on all positive HBsAg screens.  
• Include any and all ICD-9/10 diagnosis codes indicating current or recent pregnancy when ordering HBsAg tests.

Screening Pregnant Women for Hepatitis B Virus (HBV) Infection and Screening and Referral Algorithm for Hepatitis B Virus (HBV) Infection among Pregnant Women

Page one of this tool lists newly offered prenatal hepatitis B surface antigen (HBsAg) tests at four major commercial laboratories that indicate pregnancy status on reportable positive HBsAg results. Page two provides a clinical algorithm for screening and referral of pregnant women who are HBsAg-positive.  Tool [PDF- 2 pages]

Health Departments:

• Be aware of how laboratories reporting to your jurisdiction are reporting pregnancy information (e.g. including the word “prenatal”, providing ICD-9/10 codes).
• Pull these prenatal indicators from both paper-based and electronic laboratory reporting (ELR) reports.  
• Ensure prenatal indicators are shared with your Perinatal Hepatitis B Prevention Program Coordinators.  

Please contact dvhwi@cdc.gov for prenatal indicator information for ARUP Laboratories, LabCorp, Mayo Medical Laboratories, and Quest Diagnostics. 

Background

Infants born to women who are hepatitis B surface antigen (HBsAg)-positive are at high risk of hepatitis B virus (HBV) infection.  In the absence of treatment, infants infected with HBV have a 90% risk of progression to chronic hepatitis B and up to 25% of infants who acquire chronic HBV infection will die prematurely from HBV-related hepatocellular carcinoma or cirrhosis.  In 1988, the Advisory Committee on Immunization Practices (ACIP) recommended that all pregnant women should be screened for HBsAg with each pregnancy to ensure that infants born to HBsAg-positive women receive post-exposure prophylaxis, which is up to 95% effective in preventing perinatal HBV infection. 

The Council of State and Territorial Epidemiologists (CSTE) recommends that all HBsAg-positive tests are reported to public health departments in all states in order for perinatal hepatitis B prevention coordinators to follow up and ensure appropriate management of the infants.  Although some screening studies have estimated that about 95% of pregnant women receive prenatal HBsAg testing, fewer than half of the expected births to HBsAg-positive women are identified, indicating not all HBsAg-positive pregnant women are reported to and identified by perinatal hepatitis B coordinators at health departments.

Reasons for health departments missing HBsAg-positive pregnant women include underreporting, improper ordering by healthcare providers, misinterpretation of test results, and importantly, provision of test results without information to identify tests from pregnant women.

As per Clinical Laboratory Improvement Amendment (CLIA) regulations, laboratory reports are only required to have gender and age/date of birth, so pregnancy status is not typically reported to health departments.  To help improve identification of HBsAg-positive pregnant women , CDC and partners from health departments, commercial laboratories, the American College of Obstetricians and Gynecologists (ACOG) and other professional organizations have worked together to include pregnancy status in laboratory test reports sent to health departments.  These efforts were guided by recommendations of CSTE to improve identification of HBsAg-positive pregnant women.   

Four major commercial laboratories are currently participating in this effort: ARUP Laboratories, LabCorp, Mayo Medical Laboratories, and Quest Diagnostics.  Each laboratory now offers designated HBsAg tests for pregnant women as a standalone assay and/or as part of a prenatal/obstetric panel to facilitate reporting HBsAg-positive women to health departments.  When a designated prenatal HBsAg test is ordered from a lab and the result is positive, a Special Laboratory Report (SLR) indicating pregnancy status is automatically sent to the appropriate health department. 

An effort is underway to expand this reporting of pregnancy status and engage all laboratories providing HBsAg-testing services in this public health initiative.

CDC Resources:

• Centers for Disease Control and Prevention (CDC). Recommendations for identification and public health management of persons with chronic hepatitis B virus infection [PDF - 28 pages]. MMWR 2008;57(RR-08).
• Centers for Disease Control and Prevention (CDC). A comprehensive immunization strategy to eliminate transmission of hepatitis B virus infection in the United States. Recommendations of the Advisory Committee on Immunization Practices (ACIP) part 1: immunization of infants, children, and adolescents [PDF - 39 pages]. MMWR 2005;54(RR-16).
• CDC Perinatal Hepatitis B Prevention website
• CDC/ACOG Prenatal HBsAg Test Guide and Referral Algorithm [PDF - 2 pages]
• Memo to US Labs Offering HBsAg Screening Assays [PDF - 2 pages]

Additional Resources:

• The American College of Obstetricians and Gynecologists - Immunization for Women: About Hepatitis B
• American Congress of Obstetricians and Gynecologists
• US Preventive Services Task Force (USPSTF). Screening for Hepatitis B Virus Infection in Pregnancy: U.S. Preventive Services Task Force Reaffirmation Recommendation Statement. Ann Intern Med 2009;150;869-873.
• Clinical Laboratory Improvement Amendment (CLIA), 42 CFR § 493.1241