Technical Guidance for PCRF / PHER

Att 4b_Technical Guidance PCRF_PHER_20151030_v4_OMB.pdf

National HIV Surveillance System (NHSS)

Technical Guidance for PCRF / PHER

OMB: 0920-0573

Document [pdf]
Download: pdf | pdf
National HIV Surveillance System (NHSS)

Attachment 4b.
Technical Guidance of the Pediatric HIV Confidential Case Report Form
Including Supplemental Activity 3: Perinatal HIV Exposure Reporting (PHER)

TG Revised 11/2/2015

Technical Guidance for
HIV Surveillance
Programs
Pediatric HIV Confidential Case
Report Form and Perinatal HIV Exposure
Reporting Form

HIV Incidence and Case Surveillance Branch
Atlanta, Georgia
1

TG Revised 11/2/2015
Technical Guidance for HIV Surveillance Programs — Pediatric HIV Confidential Case Report

Contents — Pediatric HIV Confidential Case Report
Instructions for Completion ................................................................................. 2-3
Purpose of Case Report Form ..........................................................................2-3
The Case Report Form in the Context of Document-Based Surveillance ....... 2-3
Patients for Whom Form is Indicated................................................................ 2-3
Definition of Variable Designators ................................................................... 2-3
Disposition of Form .......................................................................................... 2-4
Section I, Patient Identification.............……………………………..........................2-4
Section II, Health Department Use Only...........................................................2-6
Section III, Facility Providing Information............................................................... 2-7
Section IV, Patient Demographics ................................................................... 2-8
Section V, Residence at Diagnosis...................................................................2-11
Section VI, State/Local Use Only .....................................................................2-11
Section VII, Facility of Diagnosis………………………………………………....2-12
Section VIII, Patient History............................................................................ 2-13
Section IX, Laboratory Data............................................................................. 2-18
Section X, Clinical……………………………………………….......................... 2-23
Section XI, Birth History (for Perinatal Cases Only).........................................2-24
Section XII, Services Referral …...................................................................... 2-28
Section XIII, Comments…………………………................................................ 2-29
Section XIV, Local/Optional Fields………………………………………………..2-29
Appendix: Pediatric HIV Confidential Case Report (CDC 50.42B).................... 2-30
Instructions for Completion ............................................................................... 2-30
Purpose ........................................................................................................... 2-30
Pediatric Cases of Public Health Importance (COPHI) ................................... 2-31
Section IV, Patient demographics.................................................................... 2-31
Section V, Residence of Diagnosis.................................................................. 2-37
Section VII, Facility of Diagnosis………………………………………...………..2-37
Section VIII, Patient history............................................................................... 2-38
Section X, Clinical………................................................................................. 2-39
Section XI, Birth history (for Perinatal Cases Only)........................................... 2-39
Section XII, Services Referral ……………………............................................ 2-41

2

TG Revised 11/2/2015

Technical Guidance for HIV Surveillance Programs — Pediatric HIV Confidential
Case Report
Instructions for Completion
Purpose of Case Report Form
The Pediatric HIV Confidential Case Report (CDC 50.42B) form (PCRF) is designed to collect information that
promotes understanding of HIV infection morbidity and mortality among patients less than 13 years of age at
time of diagnosis. This form reflects data that is required to be collected and some that is recommended or
optional. This guidance applies to all HIV infection data collection even if state or local surveillance programs
use a different form or medium for HIV case surveillance. See Appendix for further guidance.
The Case Report Form in the Context of Document-Based Surveillance
Unlike case-based data management, document-based data management allows all documents to be stored and
retained electronically in their original formats. Instead of completing one form for a reported case, fill out the
applicable part of the form for each data source contributing information to that HIV case.
Patients for Whom Form is Indicated
• Each child less than 13 years of age, who meets the HIV infection or stage 3 (AIDS) case definition
(available at http://wwwn.cdc.gov/nndss/conditions/hiv-infection/).
• In areas with confidential perinatal exposure HIV reporting, all children born to HIV-infected
mothers.
• Includes each child whose infection status has not yet been determined, seroconverters, and those
exposed but determined not to be infected with HIV; inclusion of such patients is for public health
surveillance purposes only.
• Each child with HIV infection progressing from an earlier or unknown stage to stage 3 (AIDS)
diagnosis.
• Each child with HIV infection who has been reported but for whom updated information is available
such as new CD4 or viral load tests reported from a medical provider, additional risk factor
information, updated current address information, or a change in vital status.
If the data is collected electronically and can be imported, recording the information on a hardcopy form is not
necessary. A federal assurance of confidentiality applies to information on children exposed perinatally with or
without consequent infection.
Definition of Variable Designators
• Required: Variables that must be collected by all programs.
• Recommended: Variables that programs are strongly encouraged to collect but are not absolutely
required.
• Optional: Variables that programs may or may not choose to collect.
• System generated: Variables where the value is generated by the Centers for Disease Control and
Prevention (CDC)-supplied software.
Disposition of Form
• The completed form is for state or local health agency use and is not to be sent to the CDC. The
3

TG Revised 11/2/2015
Pacific Islands are the only jurisdictions that send forms to CDC for data entry and all patient
identifiers must be removed before they are sent.
• Data obtained from these forms are entered into standardized computer software provided by the
Division of HIV/AIDS Prevention, National Center for HIV, Viral Hepatitis, STD, and TB
Prevention, CDC, and then transferred without identifiers to CDC by encrypted electronic transfer
via a secure data network.
1. Patient Identification

*Information NOT transmitted to CDC
Patient identifier information is for state and local health department use only and is not transmitted to CDC
if marked with an * on the form. Enter the data below for all children reported with HIV infection.
1.1
1.2
1.3

FIRST NAME (Required, applies to health department & health care providers)
• Enter patient’s first name
MIDDLE NAME (Optional, applies to health department & health care providers)
• Enter patient’s middle name.
LAST NAME (Required, applies to health department & health care providers)
• Enter patient’s last name.

1.2

LAST NAME SOUNDEX (System generated)
• After patient name is entered into CDC-supplied software, the software automatically generates
this variable by using the patient’s last name. After the code is generated, health department staff
should fill in this field on the form.
• This variable is a phonetic, alphanumeric code calculated by converting a surname into an index
letter and a three-digit code. The index letter is the first letter of the surname. The eHARS
Technical Reference Guide describes exactly how the Last Name Soundex is created.
• You can access the eHARS Technical Reference Guide through SharePoint:
https://partner.cdc.gov/CookieAuth.dll?GetLogon?curl=Z2FSitesZ2FNCHHSTPZ2FHICSB&reas
on=0&formdir=6.

1.3

ALTERNATE NAME TYPE (Optional, applies to health department & health care providers)
• If available, write in the alternate name type (e.g., Alias, Birth Name)

1.4

ALTERNATE FIRST NAME (Optional, applies to health department & health care providers)
•

1.5

Enter patient’s alternate first name.

ALTERNATE MIDDLE NAME (Optional, applies to health department & health care providers)
4

TG Revised 11/2/2015
• Enter patient’s alternate middle name.
16

ALTERNATE LAST NAME (Optional, applies to health department & health care providers)
•

Enter patient’s alternate last name.

1.7 ADDRESS TYPE (Required, applies to health department & health care providers)
• Select one of the address types for the patient’s current address.
1.8 CURRENT ADDRESS, STREET (Required, applies to health department & health care providers)
• Enter the patient’s current street address.
1.9

ADDRESS DATE (Required, applies to health department & health care providers)
• Enter the most recent date through which the patient was known to be residing at the current
address specified in 1.10.
• Enter date in mm/dd/yyyy format using ‘..’ for unknown values (e.g., 03/../2011).

1.10 PHONE (Required if patient has a telephone, applies to health department & health care providers)
• Enter patient’s primary area code and telephone number associated with the current address
specified in 1.10.
1.11 CITY (Required, applies to health department & health care providers)
• Enter patient’s current city.
1.12 COUNTY (Required, applies to health department & health care providers)
• Enter patient’s current county.
1.13 STATE/COUNTRY (Required, applies to health department & health care providers)
• Enter patient’s current state and country name.
1.14 ZIP CODE (Required, applies to health department & health care providers)
• Enter patient’s current zip code.
1.15 MEDICAL RECORD NUMBER (Optional, applies to health department & health care providers)
• Enter medical record number of the patient if available.
• This field may be left blank unless patient was hospitalized as an inpatient or treated as an
outpatient in a hospital, community health center, or health department clinic.
• If the patient has more than one medical record number, enter the number of the primary record
that has HIV infection or stage 3 (AIDS) documentation. Additional numbers can be noted in the
Comments section annotating which facility is associated with which record number.
1.16–1.17 OTHER ID TYPE and NUMBER (Optional, applies to health department & health care
providers)
• Enter any additional patient identifier type (such as social security number) and the number of the
other identifier. For a list of ID types, please reference the eHARS Technical Reference Guide.

5

TG Revised 11/2/2015
2. Health Department Use Only

2.1

DATE RECEIVED AT HEALTH DEPARTMENT (Recommended, applies to health department)
• Enter date in mmddyyyy format using ‘..’ for unknown values (e.g., 03/../2011).

2.2

eHARS DOCUMENT UID (System generated)
• Enter UID after CDC-supplied software generates this variable.

2.3

STATE NUMBER (Required, applies to health department)
• Enter the assigned state patient number.
• Each patient should have a unique state number throughout the course of HIV disease in each
state/jurisdiction where they are reported.
• Assigned numbers should not be reused, even if the case is later deleted.
• This variable is used, along with the state of report, to uniquely identify cases
reported to CDC and to merge with state datasets without duplication.

2.4

REPORTING HEALTH DEPARTMENT -CITY/COUNTY (Required, applies to health department)
• Enter name of city and county of the health department that receives the report from providers of
surveillance data.

2.5

CITY/COUNTY NUMBER (Optional, applies to health department)
• Enter the assigned city/county patient number.
• Each patient should have a unique city/county number throughout the course of HIV disease
assigned by the separately funded city in which they are reported.
• Assigned numbers should not be reused, even if the case is later deleted.

2.6

DOCUMENT SOURCE (Required, applies to health department)
• Enter the code for the document source that provided the information for this report (formerly
report source).
• To clearly identify multiple data sources for a given HIV case (all stages), use a separate case
report form for each source.
• Refer to the eHARS Technical Reference Guide for a list of the allowable document source codes.

2.7

SURVEILLANCE METHOD (Required, applies to health department)
• Enter the method the case report was ascertained.
• For definitions of active, passive, follow up, re-abstraction refer to the file Source Data and
Completeness of Reporting.

2.8 DID THIS REPORT INITIATE A NEW INVESTIGATION? (Optional, applies to health
department)
• Enter whether this case report initiated a new investigation by the health department.
6

TG Revised 11/2/2015
2.9 REPORT MEDIUM (Optional, applies to health department)
• Health department staff review medical records at provider facilities (i.e., field visits) or receive
information over the telephone, by fax, US mail, or other method, to establish an HIV case and to
elicit information for HIV case report forms. The health department can also receive HIV case
reports from physicians, laboratories, or other individuals or institutions through electronic transfer
or CD/disks. Enter the medium in which the case report was submitted.
3. Facility Providing Information

3.1

FACILITY NAME (Recommended, applies to health department & health care providers)
• Enter name of the facility providing the information.
• If data was reported from different facilities, enter name of each on separate forms.

3.2

PHONE (Recommended, applies to health department & health care providers)
• Enter facility’s current area code and telephone number.

3.3

STREET ADDRESS (Recommended, applies to health department & health care providers)
• Enter facility’s street address.
CITY (Recommended, applies to health department & health care providers)
• Enter city where facility providing information is located.

3.4

3.5 COUNTY (Recommended, applies to health department & health care providers)
• Enter county where facility providing information is located.
3.6
3.7

STATE/COUNTRY (Recommended, applies to health department & health care providers)
• Enter state and country name where facility providing information is located.
ZIP CODE (Recommended, applies to health department & health care providers)
• Enter ZIP code where facility providing information is located.

3.8

FACILITY TYPE (Required, applies to health department & health care providers)
• Select the type of facility providing information.
• Refer to the eHARS Technical Reference Guide for additional information regarding allowable
facility types.

3.9

DATE FORM COMPLETED (Required, applies to health department & health care providers)
• Enter date in mmddyyyy format using ‘..’ for unknown values (e.g., 03/../2011).

3.10 PERSON COMPLETING FORM (Optional, applies to health department & health care providers)
• Enter the name of the person completing the form who can be contacted to clarify entries and
supply additional information.

7

TG Revised 11/2/2015
3.11 PHONE (Recommended, applies to health department & health care providers)
• Enter the telephone number of the person completing the form.
4. Patient Demographics

4.1

DIAGNOSTIC STATUS AT REPORT (Optional, applies to health department & health care
providers)
• Use one form to capture each event regardless of the interval between diagnostic status dates, and
where the same source of these data reported more than one event.. Fill out suitable number of case
report forms:
• Fill out the first form completely for the first diagnosis.
• Fill out subsequent forms partially, capturing additional or updated data absent from the first
form.
• Forms referred to in the preceding bulleted item must include at least the following data:
Diagnostic Status Report; Residence at Diagnosis (see Residence at Diagnosis below); and Facility
of Diagnosis (see Facility of Diagnosis below).
• Status depends on child’s age, clinical profile, and laboratory findings. Refer to Appendix 4.1.1–
4.1.4 for further guidance.
4.1.1 PERINATAL HIV EXPOSURE
• Select “Perinatal HIV Exposure” if the patient is less than 18 months of age, was born to an
HIV-infected mother, and does not meet the criteria for HIV infection or the criteria for
“Not Infected with HIV.”
• Refer to Appendix 4.1.1 for further guidance.
4.1.2 PEDIATRIC HIV
• Select “Pediatric HIV” if the patient meets the criteria specified in the Revised Surveillance
Case Definition for HIV Infection in children < 13 years of age and does not meet the
current CDC pediatric HIV (stage 3) or AIDS case definition.
• Refer to Appendix 4.1.2 for further guidance.
4.1.3 PEDIATRIC stage 3 or AIDS
• Select “Pediatric AIDS” if patient meets the current HIV infection stage 3 case definition for
children < 13 years of age.
• Refer to Appendix 4.1.3 for further guidance.
4.1.4 PEDIATRIC SEROREVERTER
• Select “Seroreverter” if the perinatally exposed child initially has a positive HIV test but is
found NOT to be HIV-infected through criteria listed in Appendix 4.1.4.
8

TG Revised 11/2/2015
• Of the four diagnostic status categories available on the case report form (CRF), “Pediatric
Seroreverter” is synonymous with “Not Infected with HIV.”
4.2

SEX ASSIGNED AT BIRTH (Required, applies to health department & health care providers)
• Select patient’s sex assigned at birth.
• In addition to “Male” or “Female” sex at birth, CDC-supplied software includes a third choice of
“Unknown.”

4.3

COUNTRY OF BIRTH (Recommended, applies to health department & health care providers)
• Select applicable response.
• For patients born in US minor outlying areas, specify the name of the US dependency from the
following table:
US Dependencies
Baker Island

Midway Islands

Howland Island

Navassa Island

Jarvis Island

Palmyra Atoll

Johnston Atoll

Wake Island

Kingman Reef
•

For patients born in any other area outside of the US and US minor outlying areas, specify the
country/US dependency name.

4.4

DATE OF BIRTH (Required, applies to health department & health care providers)
• Enter patient’s date of birth in mmddyyyy format using ‘..’ for unknown values (e.g., 03/../2011).

4.5

ALIAS DATE OF BIRTH (Optional, applies to health department & health care providers)
• If available, enter the Alias date of birth in mmddyyyy format using ‘..’ for unknown values (e.g.,
03/../2011).

4.6 VITAL STATUS (Required, applies to health department & health care providers)
• Enter vital status at time of this report.
• For further guidance on death ascertainment, see the file Death Ascertainment.
4.7 DATE OF DEATH (Required if applicable, applies to health department & health care providers)
• If patient is deceased, enter date of death in mmddyyyy format using ‘..’ for unknown values (e.g.,
03/../2011).
• For further guidance on death ascertainment, see the file Death Ascertainment.
4.8

STATE OF DEATH (Required, if applicable, applies to health department & health care providers)
• If patient is deceased, enter the state name where the death occurred. If the death occurred
outside of the US, enter “Foreign Country”.

4.9

DATE OF LAST MEDICAL EVALUATION (Optional, applies to health department & health care
providers)
• Enter the date of the child’s last medical evaluation in mmddyyyy format using ‘..’ for unknown
values (e.g., 03/../2011) regardless of reason for exam. This includes emergency room visits.

4.10 DATE OF INITIAL EVALUATION FOR HIV INFECTION (Optional, applies to health department
& health care providers)
9

TG Revised 11/2/2015
• Enter the date of initial evaluation for HIV infection in mmddyyyy format using ‘..’ for unknown
values (e.g., 03/../2011). This is the date when HIV infection was first considered, either clinically
or through laboratory evaluation.
• For a child whose mother is known to be HIV infected at the time of birth and for whom
assessment of HIV is done at birth, use the date of birth. This assessment does not necessarily
include an order for an HIV test, although documentation of an HIV test is often the earliest
evidence that the diagnosis was considered.
• Evidence of HIV infection in a child must be obtained on or after the birth date.
4.11 ETHNICITY (Required, applies to health department & health care providers)
• If search for this datum was completed and ethnicity could not be determined or if ethnicity was
documented to be unknown, select “Unknown”.
• If no search for this datum was completed, leave this field blank.
• Regardless of the availability of data on race, collect data on ethnicity.
• As of January 2003, the US Office of Management and Budget (OMB) required that race and
ethnicity (Hispanic/Latino, Not Hispanic/Latino) for a person be collected as separate variables.
• A wide variety of ethnicities may be selected from values available in CDC-supplied software.
These ethnicities and codes are documented in the eHARS Technical Reference Guide.
4.12 EXPANDED ETHNICITY (Optional if applicable, applies to health department & health care
providers)
•
•

Enter more specific ethnicity information for greater detail such as “Hispanic or Latino - Cuban”
or “Hispanic or Latino - Puerto Rican”.
Refer to the eHARS Technical Reference Guide for listing of expanded ethnicity.

4.13 RACE (Required, applies to health department & health care providers)
• Select patient’s race even if information was submitted for ethnicity.
• Select more than one race if applicable.
• If no race information is available, select “Unknown”.
• As of January 2003, the US Office of Management and Budget (OMB) required that systems
collect multiple races for a person (OMB Policy Directive 15 updated standards); at a minimum,
collect data on the following five categories: American Indian or Alaska Native, Asian, Black or
African American, Native Hawaiian or Other Pacific Islander, and White.
• Refer to the eHARS Technical Reference Guide for further details.
4.14 EXPANDED RACE (Optional, if applicable, applies to health department & health care providers)
•
•

Enter more specific race information for greater detail such as “American Indian or Alaska
Native.Navajo” or “White.Middle Eastern or North African”.
Refer to the eHARS Technical Reference Guide for listing of expanded race.

10

TG Revised 11/2/2015
5. Residence at Diagnosis

•

Refer to Appendix 5.0 for further guidance.
• If patient’s residence at HIV diagnosis and stage 3 (AIDS) diagnosis are different, enter the
address information associated with the stage 3 (AIDS) diagnosis in the Comments section.

5.1

ADDRESS TYPE (Required, applies to health department & health care providers)
• Select the address type for the patient’s residence at diagnosis.
• If the patient’s residence at HIV diagnosis and stage 3 (AIDS) diagnosis was the same, you may
check both.

5.2

STREET ADDRESS (Required, applies to health department & health care providers)
• Enter street address of residence at diagnosis.

5.3

ADDRESS DATE (Required, applies to health department & health care providers)
• Enter the earliest date on or after the date of diagnosis that the patient was known to be residing at
the address specified in 5.2.
• Enter date in mm/dd/yyyy format using ‘..’ for unknown values (e.g., 03/../2011).
CITY (Required, applies to health department & health care providers)
• Enter city of residence at diagnosis.
COUNTY (Required, applies to health department & health care providers)
• Enter county of residence at diagnosis.
STATE/COUNTRY (Required, applies to health department & health care providers)
• Enter the state and country name of residence at diagnosis.
ZIP CODE (Required, applies to health department & health care providers)
• Enter the ZIP code of residence at diagnosis.

5.4
5.5
5.6
5.7

6. State/Local Use Only

The information in this section is not transmitted to CDC and is meant only for state and local health
department use. State and local health departments should develop their own policies for collecting the data
elements within this section. Collection of information within this section is Optional.

11

TG Revised 11/2/2015
7. Facility of Diagnosis

•

If the patient’s HIV diagnosis and stage 3 (AIDS) diagnosis occurred at
different facilities, enter the stage 3 (AIDS) facility information in the
Comments section.

7.1

DIAGNOSIS TYPE (Recommended, applies to health department & health care providers)
• Enter the diagnosis type that corresponds to the facility of diagnosis being
reported.

7.2

FACILITY NAME (Recommended, applies to health department & health care providers)
• Enter name of the facility where patient was first diagnosed which
corresponds with the “Diagnosis Type” reported in 7.1.
• Refer to Appendix 7.2 for further details.

7.3

PHONE (Recommended, applies to health department & health care providers)
• Enter area code and telephone number of the facility of diagnosis.

7.4

STREET ADDRESS (Recommended, applies to health department & health care providers)
• Enter street address of the facility of diagnosis.

7.5

CITY (Recommended, applies to health department & health care providers)
• Enter city of the facility of diagnosis.

7.6

COUNTY (Recommended, applies to health department & health care providers)
• Enter county of the facility of diagnosis.

7.7

STATE/COUNTRY (Recommended, applies to health department & health care providers)
• Enter state and country name of the facility of diagnosis.

7.8

ZIP CODE (Recommended, applies to health department & health care providers)
• Enter ZIP code where the facility of diagnosis is located.
7.9 FACILITY TYPE (Required applies to health department & health care
providers)
• Select the type of facility of diagnosis.
• Refer to the eHARS Technical Reference Guide for listing of facility types.

7.10 PROVIDER NAME (Recommended, applies to health department & health care providers)
• Enter provider’s name where the patient was first diagnosed which
12

TG Revised 11/2/2015
corresponds with the “Diagnosis Type” reported in 7.1.
7.11 PROVIDER PHONE (Recommended, applies to health department & health care
providers)
• Enter area code and telephone number for provider selected in 7.10.
7.12 SPECIALTY (Optional, applies to health department & health care providers)
• Enter provider’s specialty for provider selected in 7.10.

8. Patient History

These data yield information about how patients may have acquired their infection.
Respond to each risk factor, selecting “Yes” for all factors that apply; “No” for those that do not apply
(only select “No” if medical record specifically states this is not a risk factor); and “Unknown” for those
for which investigation failed to yield an answer. If an investigation for a particular item was not
performed, then you should leave it blank. Collect data about risk factors that occurred before the earliest
known diagnosis of HIV infection. For further guidance, see the file Risk Factor Ascertainment.
Information on the child refers to circumstances or behaviors that were thought to have exposed the child
13

TG Revised 11/2/2015
to HIV, not to treatments since the child became HIV infected. For example, if the child received a blood
transfusion after the documentation of HIV infection, do not enter that information on the form.
The state or local Cases of Public Health Importance (COPHI) coordinator should contact the CDC
COPHI coordinator as soon as possible if any unusual transmission circumstances are suspected. COPHI
is covered in Technical Guidance, Risk Factor Ascertainment.
8.1

CHILD’S BIOLOGICAL MOTHER’S HIV INFECTION STATUS (Required, applies to
health department & health care providers)
• If mother was diagnosed with HIV infection, select from boxes 3–8 (i.e., box “Known HIV+
before pregnancy” to box “HIV+, time of diagnosis unknown”), depending on information
available to determine the timing of her diagnosis. Where date of mother’s first positive HIV
confirmatory test is available, select the appropriate box by comparing the date of birth to
the date of the mother’s diagnosis.
• Refer to Appendix 8.1 for further guidance.

8.2

DATE OF MOTHER’S FIRST POSITIVE HIV CONFIRMATORY TEST (Optional, applies
to health department & health care providers)
•
•

Where mother is known to be HIV infected, enter month, day, and year of the first positive
HIV confirmatory test in mmddyyyy format using ‘..’ for unknown values (e.g., 03/../2011).
Refer to Appendix 8.2 for further guidance.

8.3

WAS THE BIOLOGICAL MOTHER COUNSELED ABOUT HIV TESTING DURING THIS
PREGNANCY, LABOR, OR DELIVERY? (Optional, applies to health department & health
care providers)
• Complete this question for all mothers regardless of whether they were diagnosed with HIV
infection before this pregnancy.
• Select “Yes” if mother was counseled at any time during this pregnancy, labor, or delivery
by a health care provider (private or public) about the risks of HIV in pregnancy and the
risks, benefits, and meaning of HIV testing.
• If not, select “No.”
• If no information in the medical chart is available regarding counseling, then select
“Unknown”.

8.4

AFTER 1977, AND BEFORE THE EARLIEST KNOWN DIAGNOSIS OF HIV INFECTION,
THIS CHILD’S BIOLOGICAL MOTHER HAD:
8.4.1 PERINATALLY ACQUIRED HIV INFECTION (Required, applies to health
department & health care providers)
• Select applicable response.
8.4.2 INJECTED NON-PRESCRIPTION DRUGS (Required, applies to health department &
health care providers)
• Select applicable response.

8.5

BIOLOGICAL MOTHER HAD HETEROSEXUAL RELATIONS WITH ANY OF THE
FOLLOWING:
• This section relates to ascertainment of risk among heterosexual sex partners of the
biological mother of the case patient.
• Verification of sex partner’s HIV infection status is not necessary.
14

TG Revised 11/2/2015
8.5.1 INTRAVENOUS/INJECTION DRUG USER (Required, applies to health department &
health care providers)
• Select applicable response.
8.5.2 BISEXUAL MALE (Required, applies to health department & health care providers)
• Select applicable response.
8.5.3 PERSON WITH HEMOPHILIA/COAGULATION DISORDER WITH DOCUMENTED
HIV INFECTION (Required, applies to health department & health care providers)
• “Coagulation disorder” or “hemophilia” refers only to a disorder of a clotting factor,
which is any of the circulating proteins named Factor I, Factor II, Factor III, etc.,
through Factor XII. These disorders include Hemophilia A and Von Willebrand’s
disease (Factor VIII disorders) and Hemophilia B (a Factor IX disorder).
• Refer to Appendix 8.5.3 for further guidance.
• If yes, alert the state/local Cases of Public Health Importance (COPHI) coordinator.
8.5.4 TRANSFUSION RECIPIENT WITH DOCUMENTED HIV INFECTION (Required,
applies to health department & health care providers)
• Consider documenting the reason for transfusion in the comments section.
• Refer to Appendix 8.5.4 for further guidance.
• If yes, alert the state/local Cases of Public Health Importance (COPHI) coordinator.
8.5.5 TRANSPLANT RECIPIENT WITH DOCUMENTED HIV INFECTION (Required,
applies to health department & health care providers)
• Consider documenting the reason for transfusion/transplant in the Comments section.
• If yes, alert the state/local Cases of Public Health Importance (COPHI) coordinator.
8.5.6 PERSON WITH DOCUMENTED HIV INFECTION, RISK NOT SPECIFIED
(Required, applies to health department & health care providers)
• Select “Yes” only if male partner is known to be HIV-positive and that partner’s risk
for HIV is unknown.
8.5.7 RECEIVED TRANSFUSION OF BLOOD/BLOOD COMPONENTS (OTHER THAN
CLOTTING FACTOR) (each element Required, applies to health department & health
care providers)
• ‘Blood,’ is defined as a circulating tissue composed of a fluid portion (plasma) with
suspended formed elements (red blood cells, white blood cells, platelets).
• ‘Blood components’ that can be transfused, include erythrocytes, leukocytes, platelets,
and plasma.
• If “Yes,” specify the month, day, and year of the first and last transfusion before the
child’s biological mother received a diagnosis of HIV infection (stage 1,2, unknown)
or stage 3 (AIDS). Enter date in mmddyyyy format using ‘..’ for unknown values
(e.g., 03/../2011).
• Consider documenting the reason for transfusion/transplant in the Comments section.
• If the last transfusion was after March 1985, alert the state/local Cases of Public
Health Importance (COPHI) coordinator.
8.5.8 FIRST DATE RECEIVED (Required, applies to health department & health care
providers)
• Enter date in mmddyyyy format using ‘..’ for unknown values (e.g., 03/../2011).
8.5.9 LAST DATE RECEIVED (Required, applies to health department & health care
providers)
15

TG Revised 11/2/2015
• Enter date in mmddyyyy format using ‘..’ for unknown values (e.g., 03/../2011).
8.5.10 RECEIVED TRANSPLANT OF TISSUES/ORGANS OR ARTIFICIAL
INSEMINATION (each element Required, applies to health department & health care
providers)
• If this is the only risk factor present and the biological mother did not have a
diagnosis of HIV infection at the time of child’s birth, the transmission mode will be
initially classified as “risk not reported/identified” pending outcome of the COPHI
investigation.
• If yes, alert the state/local Cases of Public Health Importance (COPHI) coordinator.
If the biological mother is known to be HIV infected and this is the only maternal risk, then the case
patient will initially be classified as “mother has HIV infection, risk not specified”.
8.6 BEFORE THE DIAGNOSIS OF HIV INFECTION, THIS CHILD HAD
• Alert state/local COPHI coordinator if the child had one or more of the risk factors
documented in this section.
8.6.1 INJECTED NON-PRESCRIPTION DRUGS (Required, applies to health department &
health care providers)
• Select applicable response.
8.6.2 RECEIVED CLOTTING FACTOR FOR HEMOPHILIA/COAGULATION DISORDER
(Required, applies to health department & health care providers)
• “Coagulation disorder” or “hemophilia” refers only to a disorder of a clotting factor;
factors are any of the circulating proteins named Factor I through Factor XII. These
disorders include Hemophilia A and Von Willebrand’s disease (Factor VIII disorders)
and Hemophilia B (a Factor IX disorder).
• This risk factor is generally documented in the history and physical section of the
patient’s medical chart.
• They do not include other bleeding disorders, such as thrombocytopenia, treatable by
platelet transfusion.
• If only a transfusion of platelets, other blood cells, or plasma was received by the
partner, then select “No.”
• Alert state/local COPHI coordinator if child was born after March 1998 and receipt of
clotting factor is the suspected mode of HIV transmission.
8.6.3 SPECIFY CLOTTING FACTOR (Required, applies to health department & health care
providers)
• If “Yes” to 8.6.2, above, then enter the specific clotting factor.
• Enter the date the clotting factor was received in mmddyyyy format using ‘..’ for
unknown values (e.g., 03/../2011).
8.6.4 RECEIVED TRANSFUSION OF BLOOD/BLOOD COMPONENTS (OTHER THAN
CLOTTING FACTOR) (Required, applies to health department & health care providers)
• If child received a transfusion of blood cells (red cells, white cells, and platelets) or
plasma, specify month, day, and year of first and last transfusion before the patient
was infected with HIV or received a diagnosis of stage 3 or AIDS. Enter date in
mmddyyyy format using ‘..’ for unknown values (e.g., 03/../2011).
• It is often helpful to document the reason for the transfusion in the Comments section.
16

TG Revised 11/2/2015
8.6.7 RECEIVED TRANSPLANT OF TISSUE/ORGANS (Required, applies to health
department & health care providers)
• The case will be initially classified as “risk not reported/identified” pending outcome
of the no identified risk (NIR) investigation.
• If yes, alert the state/local Cases of Public Health Importance (COPHI) coordinator.
8.6.8 SEXUAL CONTACT WITH A MALE (Required, applies to health department & health
care providers)
• If child is known to have had sexual contact/abuse, mark the appropriate box.
• If this is the only risk history, the case will be initially classified as “risk not
reported/identified” pending outcome of NIR investigation.
• Alert state/local COPHI coordinator.
8.6.9 SEXUAL CONTACT WITH A FEMALE (Required, applies to health department &
health care providers)
• If the child is known to have had sexual contact/abuse, mark the appropriate box.
• If this is the only risk history, the case will be initially classified as
“risk not reported/identified” pending outcome of NIR investigation.
• Alert state/local COPHI coordinator.
8.6.10 OTHER DOCUMENTED RISK (Alert State/Local NIR Coordinator) (Required, applies
to health department & health care providers)
• Include detail in Comments section.

17

TG Revised 11/2/2015
9. Laboratory Data

Throughout this section, “Collection Date” refers to the date when the specimen was collected or
drawn. Enter collection dates in mm/dd/yyyy format using ‘..’ for unknown values (e.g., 03/../2011).
Record all laboratory tests. Include all diagnostic, viral load, and CD4 tests where possible. Where
number of tests exceeds the number of fields available on the form, record such results in the
Comments section. In the absence of lab tests, record HIV infection or stage 3(AIDS) diagnostic
evidence documented in the chart by a physician.
9.1

HIV IMMUNOASSAYS (NON-DIFFERENTIATING)
•
•

Assuming active case finding, review patient’s chart and lab reports for the earliest date of
documented HIV positivity. “Indeterminate” refers to Indeterminate HIV antibody test
results.
Enter results and collection dates for all tests that are part of the first diagnostic testing
18

TG Revised 11/2/2015
algorithm whose overall interpretation is positive (that the patient is HIV-infected).
• Enter specimen collection date in mm/dd/yyyy format using ‘..’ for unknown values (e.g.,
03/../2011).
• Check the Rapid Test box if the test is rapid.
• Enter the brand name of the test and/or its manufacturer.
9.1.1 HIV-1 IA (each element Required, applies to health department & health care providers)
• Enter result and collection date of first HIV-1 IA.
• “Positive IA” means repeatedly reactive tests on a single sample.
9.1.2 HIV-1/2 IA (each element Required, applies to health department & health care
providers)
• Enter result and collection date of first HIV-1/2 combination IA test.
9.1.3 HIV-1/2 AG/AB (each element Required, applies to health department & health care
providers)
• Enter results and collection date of combined p24 antigen and anti HIV1/2 antibody
screening assay.
9.1.4 HIV-1 WESTERN BLOT (each element Required, applies to health department & health
care providers)
• Enter the result and collection date of first HIV-1 Western blot.
• Western blot banding patterns should be interpreted according to the
CDC/Association of State and Territorial Public Health Laboratory Directors
(ASTPHLD) recommendations “Human Immunodeficiency Virus Type 1 Infections”
(MMWR, 1989:38:No.S-7).
9.1.5 HIV-1 IFA (each element Required, applies to health department & health care
providers)
• Enter the result and collection date of first HIV-1 IFA.
9.1.6 HIV-2 IA (each element Required, applies to health department & health care providers)
• Enter result and date of first HIV-2 IA.
• “Positive IA” means repeatedly reactive tests on a single sample.
9.1.7 HIV-2 WESTERN BLOT (each element Required, applies to health department & health
care providers)
• Enter the result and collection date of first HIV-2 Western blot.
9.2

HIV IMMUNOASSAYS (DIFFERENTIATING) (each element Required, applies to health
department & health care providers)
• Assuming active case finding, review patient’s chart and lab reports for the earliest date of
documented HIV positivity.
• Enter results and collection dates for all tests that are part of the first diagnostic testing
algorithm whose overall interpretation is positive (that the patient is HIV-infected).
• Enter specimen collection date in mm/dd/yyyy format using ‘..’ for unknown values (e.g.,
03/../2011).
• Check the Rapid Test box if the test is rapid.
• Enter the brand name of the test and/or its manufacturer.
9.2.1 HIV-1/2 TYPE-DIFFERENTIATING (each element Required, applies to health
19

TG Revised 11/2/2015
department & health care providers)
• Enter result and collection date of first HIV-1/2 Type Differentiating IA.
• If reports indicate HIV-1 and HIV-2 results separately, verify with the laboratory that
a type-differentiating test was performed, and enter appropriate results for a typedifferentiating test (i.e., not separate HIV-1 and HIV-2 IAs).
• If the result is HIV-1 reactive and HIV-2 reactive, check the box for “Both
(undifferentiated)” on the ACRF. This indicates that antibodies to both HIV-1 and
HIV-2 were detected.
9.2.2 HIV-1/2 AG/AB-DIFFERENTIATING (each element Required, applies to health
department & health care providers)
• Enter result and collection date of first HIV-1/2 Ag/Ab-Differentiating IA.
• If the result is HIV Ab reactive or HIV-1 Ag reactive and HIV Ab reactive, check the
box for “Ab reactive” or “Both (Ag and Ab reactive)”, respectively, on the ACRF.
These indicate that antibodies to HIV-1 or HIV-2 were detected.
9.2.3 HIV-1/2 AG/AB and TYPE-DIFFERENTIATING (each element Required, applies to
health department & health care providers)
• Enter result and collection date of first HIV-1/2 Ag/Ab and Type-Differentiating IA.
• Record the result for both HIV-1 Ag and HIV Ab. (That is, one result should be
recorded for HIV-1 Ag, and one result should be recorded for HIV Ab.)
9.3

HIV DETECTION TESTS (QUALITATIVE) (each element Required, applies to health
department & health care providers)
•
•
•
•

All varieties of such tests establish the presence of the pathogen, HIV. By contrast, HIV tests
such as the IA or Western blot establish the presence of the immune system’s response to the
pathogen (i.e., HIV antibodies).
Assuming active case finding, review patient’s chart and lab reports for the earliest date of
documented HIV positivity.
Enter results and collection dates for all tests that are part of the first diagnostic testing
algorithm whose overall interpretation is positive (that the patient is HIV-infected).
Enter specimen collection date in mm/dd/yyyy format using ‘..’ for unknown values (e.g.,
03/../2011).

9.3.1 HIV-1 RNA/DNA NAAT (QUAL) (each element Required, applies to health department
& health care providers)
•

Enter result and collection date of earliest NAAT.

9.3.2 HIV-1 CULTURE (each element Required, applies to health department & health care
providers)
• Enter result and collection date of earliest test by culture.
9.3.3 HIV-2 RNA/DNA NAAT (QUAL) (each element Required, applies to health department
& health care providers)
•

Enter result and collection date of earliest NAAT.

9.3.4 HIV-2 CULTURE (each element Required, applies to health department & health care
providers)
• Enter result and collection date of earliest test by culture.
20

TG Revised 11/2/2015
9.4 HIV DETECTION TESTS (QUANTITATIVE VIRAL LOAD) (each element Required,
applies to health department & health care providers)
•
•

•

9.5

Indicate if results are “Detectable” or “Undetectable”. Viral load tests with undetectable
results should also be entered.
Enter results in units of viral copies per milliliter (mL) and Log. Where detectable results are
reported with log data only, enter “greater than detection limits for this assay” under the
copies/mL field. Because undetectable results are typically reported as below the detection
limits of the assay rather than by a specific quantitative value, enter “fewer than detectable
by this assay” under the copies/mL field.
Enter specimen collection date in mm/dd/yyyy format using ‘..’ for unknown values (e.g.,
03/../2011).

9.4.1

HIV-1 RNA/DNA NAAT (QUANTITATIVE VIRAL LOAD) (each element Required,
applies to health department & health care providers).
• Enter result and collection date of earliest test.

9.4.2

HIV-2 RNA/DNA NAAT (QUANTITATIVE VIRAL LOAD) (each element Required,
applies to health department & health care providers).
• Enter result and collection date of earliest test.

IMMUNOLOGIC TESTS (CD4 COUNT AND PERCENTAGE) (each element Required,
applies to health department & health care providers)
•
•

Whenever CD4 count and percentage are both available for the same specimen collection
date, record both.
Enter specimen collection date in mm/dd/yyyy format using ‘..’ for unknown values (e.g.,
03/../2011).

9.5.1 CD4 AT OR CLOSEST TO DIAGNOSIS
This is the first CD4 result closest to the date of initial HIV infection diagnosis,
regardless of stage of disease at diagnosis.
9.5.1.1 CD4 COUNT (each element Required, applies to health department & health
care providers)
• Record the CD4 count closest to the time when the patient was determined
to be HIV infected. If this information is not available when the initial case
report is completed, it may be entered later.
• Enter result and specimen collection date of first CD4 count.
9.5.1.2 CD4 PERCENTAGE (each element Required, applies to health department &
health care providers)
• Record the CD4 percentage closest to the time when the patient was
determined to be HIV infected. If this information is not available when the
initial case report is completed, it may be entered later.
• Record result and specimen collection date of first CD4 percentage.
9.5.2 FIRST CD4 RESULT < 200 cells/μL or < 14%
This is the first CD4 result indicative of stage 3 (AIDS). The stage is based primarily on
the CD4 count; the CD4 count takes precedence over the CD4 percentage, and the
percentage is considered only if the count is missing.
9.5.2.1 CD4 COUNT (Required, applies to health department & health care providers)
21

TG Revised 11/2/2015
•

9.5.2.2

Record results and specimen collection date of first CD4 indicative of stage
3 (i.e., < 200 cells/μL).
CD4 PERCENTAGE (Required, applies to health department & health care
providers)
• Record results and specimen collection date if:
o The CD4 percentage was from a specimen collected on the same
date as the first CD4 count indicative of stage 3 (see section 9.5.2.1
above) or
o The first CD4 percentage indicative of stage 3 (i.e., <14%) was from
a specimen collected on an earlier date than the first CD4 count
indicative of stage 3 and was not accompanied by a CD4 count for
the same date.

9.5.3 Other CD4 RESULT
9.5.3.1 CD4 COUNT (Required, applies to health department & health care providers)
• Enter results and specimen collection date of other CD4 count.
9.5.3.2 CD4 PERCENTAGE (Required, applies to health department & health care
providers)
• Record results and specimen collection date of other CD4 percentage.
9.6

DOCUMENTATION OF TESTS
9.6.1 DID DOCUMENTED LABORATORY TEST RESULTS MEET APPROVED HIV
DIAGNOSTIC ALGORITHM CRITERIA? (Required if applicable, applies to health
department & health care providers)
• This section captures diagnoses through novel algorithms, and should only be
completed if none of the following were positive: HIV-1 Western blot; IFA, culture,
viral load; or qualitative NAAT (RNA or DNA).
• “Approved HIV diagnostic algorithm criteria” means any criteria that satisfy the HIV
surveillance case definition, regardless of whether approved for other purposes such
as laboratory-based HIV testing or point-of-care HIV screening.
• If “Yes”, enter date of earliest positive test for this algorithm in mm/dd/yyyy format
using ‘..’ for unknown values (e.g., 03/../2011).
9.6.2 IF HIV LABORATORY TESTS WERE NOT DOCUMENTED, IS HIV DIAGNOSIS
DOCUMENTED BY A PHYSICIAN? (Required if applicable, applies to health
department & health care providers)
• If laboratory evidence of an HIV test is unavailable in the patient’s medical or other
record and written documentation of lab evidence of HIV infection consistent with the
HIV case definition is noted by the physician, enter “Yes”; otherwise enter “No” or
“Unknown.”
• IF “YES” TO 9.6.2, PROVIDE DATE OF DIAGNOSIS BY PHYSICIAN (Required
in the absence of lab results, applies to health department & health care providers)
• Date of diagnosis is defined as the date (at least the year) of diagnosis reported in the
content of the medical record. If the diagnosis date was not reported in the note, the
date when the note was written can be used as a proxy. For example, if a health care
provider writes a note in a medical chart on 4/10/2010 stating the patient had positive
HIV EIA and WB on 2/11/2010, this should be recorded as 2/11/2010 as the date of
diagnosis by the physician.
22

TG Revised 11/2/2015
9.6.3 IF “YES” (TO 9.6.2) PROVIDE DATE OF DOCUMENTATION BY PHYSICIAN
(Required in the absence of lab results, applies to health department & health care
providers).
•

Date of diagnosis is defined as the date (at least the year) of diagnosis reported in the
content of the medical record. If the diagnosis date was not reported in the note, the
date when the note was written can be used as a proxy. For example, if a health care
provider writes a note in a medical chart on 4/10/2010 stating the patient had positive
HIV EIA and WB on 2/11/2010, this should be recorded as 2/11/2010 as the date of
diagnosis by the physician..

10. Clinical

10.1 CLINICAL
10.1.1–10.1.24 (Optional, applies to health department & health care providers)
• Select all that apply and enter diagnosis dates in mmddyyyy format using ‘..’ for
unknown values (e.g., 03/../2011).
• Refer to Appendix 10.1 for further details.
10.2 HAS THIS CHILD BEEN DIAGNOSED WITH PULMONARY TUBERCULOSIS?
(Optional, applies to health department & health care providers)
10.2.1

IF “YES,” INITIAL DIAGNOSIS (Optional, applies to health department & health
care providers)
• Select applicable response and enter date of diagnosis in mmddyyyy format using
‘..’ for unknown values (e.g., 03/../2011).

10.2.2

RVCT CASE NUMBER (Optional, applies to health department & health care
providers)
• If this patient has a verified case of tuberculosis (TB), health department staff enter
the nine-digit alphanumeric code from the TB case report or TB data management
system. Providers in the private and public sectors diagnosing tuberculosis in their
stage 3 (AIDS) patients may get this number from TB surveillance staff.
23

TG Revised 11/2/2015

11. Birth History (for Perinatal Cases Only)

11.1

BIRTH HISTORY AVAILABLE (Optional, applies to health department & health care
providers)
• If birth history is not available, proceed to next section.
• Enter the street address, city, county, state, country name, and zip code of the patient’s
residence at time of birth.

11.2

FACILITY OF BIRTH (Optional, applies to health department & health care providers)
• Check if same as facility providing information.
• Enter name, address, phone, city, county, state/country and zip code of the hospital/clinic
of birth.
• Sites should uniformly record hospital names, including abbreviations.
• If this child was born at home, enter “home birth”.

11.4

BIRTH HISTORY
11.4.1

BIRTH WEIGHT (Optional, applies to health department & health care providers)
• Enter the birth weight in pounds and ounces, or grams.
24

TG Revised 11/2/2015
• If recorded only in pounds and ounces, convert to grams.

11.5

11.4.2

TYPE (Optional, applies to health department & health care providers)
• Select applicable response. If unknown, select “9.”

11.4.3

DELIVERY (Optional, applies to health department & health care providers)
• Elective cesarean section refers to a cesarean section that occurs before rupture of
membranes and before the onset of labor.
• Elective cesarean section has been demonstrated to reduce perinatal transmission
of HIV, if performed before the onset of labor.
• It will be important to monitor the trends in the use of elective cesarean section for
the prevention of perinatal HIV.
• Notes in the child’s records are acceptable even if no birth records are available.

11.4.4

BIRTH DEFECTS (Optional, applies to health department & health care providers)
• If “Yes,” specify type.
• Refer to Appendix 11.4.4 for further guidance and an abbreviated list of birth
defects.

NEONATAL STATUS (Optional, applies to health department & health care providers)
• Select applicable response and record the child’s gestational age, if known, in the boxes
provided.
• “Full term” is defined as gestational age greater than or equal to 37 weeks.
• “Premature” is defined as gestational age less than 37 weeks.
• If search for gestational age was unsuccessful, then enter “99” for unknown number of
weeks.
• Post mature neonatal status (after 40 weeks) should be recorded as full term.
11.5.1

11.6

NEONATAL GESTATIONAL AGE IN WEEKS
• Enter weeks of gestation.

PRENATAL CARE (Optional, applies to health department & health care providers)
• Prenatal care is defined as any care for the pregnancy beyond pregnancy testing and before
delivery, even if no regular follow-up ensued.
11.6.1

GESTATIONAL MONTH PRENATAL CARE BEGAN (Optional, applies to health
department & health care providers)
• Record the gestational month of pregnancy (01 to 09) that the mother began her
prenatal care.
• If any fraction of a month is reported, round to the next whole month.
• In the absence of prenatal care, enter “00.”
• If search for this datum was unsuccessful, then enter “99” for month of first visit.
• Refer to Appendix 11.6.1 for further guidance.

11.6.2

TOTAL NUMBER OF PRENATAL CARE VISITS (Optional, applies to health
department & health care providers)
• Record the total number of times the mother went to the clinic or doctor for her
25

TG Revised 11/2/2015
prenatal care; exclude visits unrelated to prenatal care.
• In the absence of prenatal care visits, enter “00”.
• In the presence of prenatal care and search for this datum was unsuccessful, then
enter “99” for number of prenatal visits.
• Where data source reports a range of visits (e.g., “10–13”), enter the lowest
number (e.g., “10”).
11.7

DID MOTHER RECEIVE ANTIRETROVIRALS (ARVs) PRIOR TO THIS PREGNANCY?
(Recommended, applies to health department & health care providers)
• ‘Pregnancy’ is defined as: The condition of having a developing embryo or fetus in the
body after union of an ovum and spermatozoon. Labor and delivery occur after this
interval, so they are not considered part of the ‘pregnancy’.
• If a woman did not receive ARVs, do not assume it was because she refused.
• Select “Refused” only if explicit documentation in the medical record indicates that the
patient was offered the drug, but the patient declined.
• Select “Unknown” after an unsuccessful search for this datum.
11.7.1

11.8

IF “YES,” PLEASE SPECIFY ALL

DID MOTHER RECEIVE ARVs DURING PREGNANCY? (Recommended, applies to
health department & health care providers)
• Select “Yes” if information is available that states that the mother used ARVs any time
during pregnancy
• Select “No” if mother did not use ARVs during pregnancy.
• Select “Unknown” if it is unknown whether the mother ever used ARVs during pregnancy.
11.8.1 IF “YES,” PLEASE SPECIFY ALL
• For a list of antiretroviral therapies currently available and link to treatment
guidelines, refer to Appendix 11.8.

11.9

DID MOTHER RECEIVE ARVs DURING LABOR/DELIVERY? (Recommended, applies to
health department & health care providers)
• Select “Yes” if information is available that states that the mother used ARVs any time
during labor/delivery.
• Select “No” if mother did not use ARVs during labor/delivery.
• Select “Unknown” if it is unknown whether the mother ever used ARVs during
labor/delivery.
11.9.1

IF “YES,” PLEASE SPECIFY ALL

11.10 MATERNAL INFORMATION
11.10.1 MATERNAL DATE OF BIRTH (DOB) (Optional, applies to health department &
health care providers)
• Enter the biological mother’s date of birth in mmddyyyy format using ‘..’ for
unknown values (e.g., 03/../2011).
11.10.2 MATERNAL LAST NAME SOUNDEX (Optional, applies to health department)
• Enter maternal soundex here.
• After patient name is entered into CDC-supplied software, the software
26

TG Revised 11/2/2015
automatically generates this variable by using the patient’s last name. After the
code is generated, health department staff should fill in this field on the form.
• This variable is a phonetic, alphanumeric code calculated by converting a surname
into an index letter and a three-digit code. The index letter is the first letter of the
surname. The eHARS Technical Reference Guide describes exactly how the Last
Name Soundex is created. You can access the eHARS Technical Reference Guide
through Sharepoint:
https://partner.cdc.gov/CookieAuth.dll?GetLogon?curl=Z2FsitesZ2FNCHHSTPZ
2FHICSB&reason=0&formdir=5
• Refer to Appendix 11.10.2 for further guidance.
11.10.3 MATERNAL STATENO. (Optional, applies to health department)
• Enter assigned state patient number if the biological mother is known to be HIV
infected.
• State patient numbers should not be reused.
11.10.4 MATERNAL COUNTRY OF BIRTH (Optional, applies to health department &
health care providers)
• Select applicable response.
• For mothers born in US minor outlying areas, specify the name of the US dependency from
the following table:
US Dependencies
Baker Island

Midway Islands

Howland Island

Navassa Island

Jarvis Island

Palmyra Atoll

Johnston Atoll

Wake Island

Kingman Reef

•
•

For mothers born in any other area outside of the US and US minor outlying areas, specify
the country name.
If this information is not available in the child’s records, it can be left blank and updated
on follow-up.

11.10.5 OTHER MATERNAL ID-LIST TYPE (Optional, applies to health department &
health care providers).
• Enter any other maternal ID type (such as social security number) and the number
of the other ID.

27

TG Revised 11/2/2015
12. Service Referrals

This section should be completed by the person initially notifying the health department of the HIV
case. Where health department staff populated fields in the Services Referrals section through chart
abstraction, providers of surveillance data may defer this task to public health workers.
This information should be updated for each child when there is a change in diagnostic status,
whenever possible.
12.1 NEONATAL ANTIRETROVIRALS FOR HIV PREVENTION (Recommended, applies to
health department & health care providers)
• Record whether child received any neonatal (first 6 weeks of life) ARVs to prevent
perinatal HIV infection.
• If “Yes,” record the date the child was started on antiretrovirals as prophylaxis during the
first 6 weeks of life. Enter date in mmddyyyy format using ‘..’ for unknown values (e.g.,
03/../2011).
• Refer to Appendix 12.1 for further guidance.
12.2 IF “YES,” PLEASE SPECIFY (Recommended, applies to health department & health care
providers)
• If “Yes,” write in the type of medication received.
• Examples include Didanosine (ddI, dideoxyinosine, Videx), Dideoxycytidine (ddC, HIVID,
Zalcitabine), Lamivudine (3TC, Epivir), Stavudine (d4t, Zerit), Nevirapine, Indinavir
(Crixivan), Ritonavir, and Saquinavir (Invirase).
12.3 ANTI-RETROVIRAL THERAPY FOR HIV TREATMENT (Recommended, applies to health
department & health care providers)
• Select applicable response.
• If “Yes,” record date the child started on any antiretroviral therapy for treatment of
confirmed HIV infection in mmddyyyy format using ‘..’ for unknown values (e.g.,
03/../2011).
• Please refer to the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV
Infection http://aidsinfo.nih.gov/Guidelines/GuidelineDetail.aspx?GuidelineID=8.
12.4 PCP PROPHYLAXIS (Optional, applies to health department & health care providers)
• If nothing in the medical chart indicates the use of any of these drugs or refers to the
prophylactic treatment of PCP, then select “No.”
• If “Yes,” enter the date the child was started on therapy to prevent the occurrence of PCP in
mmddyyyy format using ‘..’ for unknown values (e.g., 03/../2011).
28

TG Revised 11/2/2015
• “Unknown” is used if treatment information in the medical chart is unclear or was
unavailable.
• Refer to Appendix 12.4 for further guidance.
12.5

WAS THIS CHILD BREASTFED? (Optional, applies to health department & health care
providers)
• If there is suspicion that the child’s only exposure to HIV was through breast milk, the
local/state NIR coordinator should be alerted.
• Refer to Appendix 12.5 for further guidance.

12.6

THIS CHILD’S PRIMARY CARETAKER IS (Optional, applies to health department &
health care providers)
• Select the person who provides the majority of care for the child.
• Refer to Appendix 12.6 for further guidance.

13. Comments (Optional, applies to health department & health care providers)

•

This section can be used for information not requested on the form or for information requested
but where there might not be room in the space provided.
•

Information entered into the “Comments” tab on the PCRF of the CDC-supplied software will
not be transmitted to CDC.

14. Local/Optional Fields (Optional, applies to health department)

•
•

This section is for collection of data that is not on the form at the state and local level.
This information is not sent to CDC.

29

TG Revised 11/2/2015
Appendix: Pediatric HIV Confidential Case Report Form (CDC 50.42B)
Instructions for Completion
Purpose
•

Information captured on the Pediatric HIV Confidential Case Report Form (PCRF) provides
population-based data on diagnostic testing and initiation of prophylaxis and treatment, as well as
HIV-related morbidity and mortality among children (CARE Amendments [Section 2626]) to
support states with prevention activities.

•

CDC’s Division of HIV/AIDS Prevention (DHAP) needs initial reports and updates to reflect the
earliest dates that children meet each reporting criteria (i.e., perinatal exposure, HIV infection,
stage 3 or AIDS, seroreverter), as well as changes in diagnostic or vital status.

•

When a child who was previously reported as HIV infected has progressed to stage 3 (AIDS) or
has died, state/reporting area personnel update the National HIV Surveillance System (NHSS)
accordingly.

•

After programs receive initial reports of evidence of HIV exposure or infection among children,
surveillance staff follow up to determine whether diagnostic status of the child changes. For
example, staff updates reports of children with perinatal exposure after 6 months of age to confirm
or refute HIV infection and again at 18 months of age.

•

The PCRF can accommodate updated information including immunologic markers and diagnoses
of opportunistic infections.

•

CDC updated the PCRF and related software in 2000 to:
• evaluate the implementation and impact of the Public Health Service (PHS) recommendations
on the prevention of transmission of HIV from mother to child;
• accommodate surveillance requirements of the Ryan White CARE Act Amendments of 1996;
and
• accommodate the revised 2000 HIV case definition for perinatal HIV exposure, pediatric
infection, and those perinatally exposed but not infected with HIV.

•

In 1995, CDC added variables on receipt of maternal ARVs during pregnancy and labor/delivery
and neonatal ARV.

•

Maternal HIV counseling and testing, prenatal care, and refusal of ARV treatment were added in
1996.

•

Viral load tests, receipt of additional antiretroviral (ARV) therapy during labor/delivery for the
newborn and elective cesarean were added to the pediatric reporting form in 1999.
• These additions enable reporting areas to identify possible reasons for failures in preventing
HIV transmission related to childbirth (i.e., receipt of maternal HIV testing, prenatal care, and
antiretroviral treatment).
• As states move toward pediatric HIV exposure reporting, information on receipt of prenatal,
intrapartum, and neonatal ARV and receipt of other antiretroviral therapy can be collected for
all children born to HIV-infected women. Timely follow-up of these children to determine
infection status will aid in evaluating the impact of these recommendations most effectively.
• For evolution of the pediatric case definition, please refer to the 1987 pediatric AIDS case
definition (MMWR 1987;36(suppl):1–15S), the 1994 revised classification system for HIV
infection in children less than 13 years of age (MMWR 1994;43:(No. RR-12):1–10), and the
30

TG Revised 11/2/2015
2000 HIV case definition in the CDC Guidelines for National Human Immunodeficiency
Virus Case Surveillance, Including Monitoring for Human Immunodeficiency Virus Infection
and Acquired Immunodeficiency Syndrome (MMWR 1999;48(RR-13):1–31), available at
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr4813a1.htm, the 2008 case definition
(MMWR 2008; 57 (RR-10) 1-12 at
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5710a1.htm, and the Revised Surveillance
Case Definition for HIV Infection — United States, 2014 (MMWR 2014;63 (RR03);1-10 at
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6303a1.htm?s_cid=rr6303a1_e.
Pediatric Cases of Public Health Importance (COPHI)
Reporting area staff should continue to discuss certain priority cases directly with CDC
surveillance staff. These include HIV infection in a health care setting, HIV-2 infection, HIV
infection attributed to tissue or organ transplantation, suspected transmission due to sexual
contact, mother-to-infant transmission due to breast feeding, transfusions after March 1985, or any
other unusual transmission circumstances. This direct communication will ensure the timeliest
technical support. COPHI is covered in the Technical Guidance, Risk Factor Ascertainment.
4. PATIENT DEMOGRAPHICS
4.1

DIAGNOSTIC STATUS AT REPORT
4.1.1 PERINATAL HIV EXPOSURE
• The “Perinatal HIV Exposure” category is composed of “Presumptively Not
Infected,” “Definitively Not Infected,” and “Indeterminate.”
• A child aged less than 18 months born to an HIV-infected mother will be categorized
as having perinatal exposure to HIV infection if the child does not meet the criteria
for HIV infection or the criteria for “not infected with HIV.”
4.1.2 PEDIATRIC HIV
• Among children <18 months old whose mothers were not infected and all children
aged ≥18 months, a reportable case of HIV infection must meet at least one of the
following criteria:
1.1.1: Laboratory Evidence
Laboratory criteria require reporting of the date of the specimen collection for
tests in a multi-test algorithm or a stand-alone virologic test, and enough
information about the test(s) to determine that they meet any of the following
criteria:
1) A multi-test algorithm consisting of
o a positive result on an initial HIV antibody or combination
antigen/antibody test
and
o an accompanying or subsequent positive result on a supplemental HIV
test different from the initial test (4).
The initial HIV antibody or antigen/antibody test and the supplemental HIV
test that is used to verify the result of the initial test may be of any type used as
an aid to diagnose HIV infection. For surveillance purposes, supplemental
31

TG Revised 11/2/2015
tests may include some not approved by the FDA for diagnosis (e.g., viral load
test, HIV-2 Western blot/immunoblot antibody test, HIV-2 nucleic acid test
[NAT]). However, the initial and supplemental tests must be “orthogonal”
(i.e., have different antigenic constituents or use different principles) to
minimize the possibility of concurrent nonspecific reactivity. Because the
antigenic constituents and test principles are proprietary information that may
not be publicly available for some tests, tests will be assumed to be orthogonal
if they are of different types. Examples:
o one test is a combination antigen/antibody test and the other an
antibody-only test
o one test is an antibody test and the other a nucleic acid test (NAT)
o one test is a rapid immunoassay (a single-use analytical device that
produces results in less than 30 minutes) and the other a conventional
immunoassay
o one test is able to differentiate between HIV-1 and HIV-2 and the other
is not able to do so.
Tests will also be assumed to be orthogonal if they are of the same type (e.g.,
two conventional immunoassays) but made by different manufacturers. The
type of HIV antibody test that verifies the initial test may be one formerly used
only as an initial test (e.g., conventional or rapid immunoassay, HIV-1/2 typedifferentiating immunoassay), or it may be one traditionally used as a
supplemental test for confirmation (e.g., Western blot, immunofluorescence
assay).
or
2) Positive result of a multi-test HIV antibody algorithm from which only the
final result was reported, including a single positive result on a test used only
as a supplemental test (e.g., HIV Western blot, immunofluorescence assay) or
on a test that may be used as either an initial test or a supplemental test (e.g.,
HIV-1/2 type-differentiating rapid antibody immunoassay) when it may
reasonably be assumed to have been used as a supplemental test (e.g., because
the algorithm customarily used by the reporting laboratory is known).
or
3) Positive result or report of a detectable quantity (i.e., within the established
limits of the laboratory test) from any of the following HIV virologic (i.e.,
non-antibody) tests:
o Qualitative HIV nucleic acid (DNA or RNA) test (NAT)
o Quantitative HIV NAT (viral load assay)
o HIV p24 antigen test
o HIV isolation (viral culture)
o HIV nucleotide sequence (genotype)
1.1.2: Clinical (Non-Laboratory) Evidence
Clinical criteria for a confirmed case (i.e., a “physician-documented” diagnosis
32

TG Revised 11/2/2015
rather than a laboratory-test-documented diagnosis) are met by the combination
of:
• A note written by a physician or other qualified medical-care provider that
does not meet the laboratory criteria described above but states that the patient
has HIV infection,
and
• One or both of the following:
o The laboratory criteria for a case were met based on tests done after the
physician’s note was written (validating the note retrospectively)
or
o Circumstantial evidence of HIV infection (e.g., receipt of HIV
antiretroviral therapy, prophylaxis for an opportunistic infection), an
otherwise unexplained low CD4+ T-lymphocyte count (or
percentage), or an otherwise unexplained diagnosis of an opportunistic
illness indicative of stage 3 [see Table 1])
• Among children aged less than 18 months, a reportable case of HIV infection must
meet at least one of the following criteria:
1.2: Children Aged <18 Months Born to Mothers Who Have an Unknown
Infection Status or were Known to be Infected
1.2.1: Laboratory Evidence
A child aged <18 months is categorized for surveillance purposes as HIV infected if
all of the following criteria are met:
• Positive results on at least one specimen (not including cord blood) from any of
following HIV virologic tests
o HIV nucleic acid (DNA or RNA) test (NAT)
o HIV p24 antigen test, including neutralization assay, for a child aged >1
month
o HIV isolation (viral culture)
o HIV nucleotide sequence (genotype)
and
• Reporting of the date of the test (at least the year and month; this should be the
date of specimen collection, if known)
and
• One or both of the following:
o Confirmation of the first positive result by another positive result on one
of the above virologic tests from a specimen obtained on a different date
and/or
o Both of the following:
 No subsequent negative result on an HIV antibody test
and
 No subsequent negative result on an HIV NAT before 18 months of
age
33

TG Revised 11/2/2015
1.2.2: Clinical Evidence
• The same criteria as for persons aged 18 months through adult (section 1.1.2
above)
or
• The following alternative criteria
o Evidence of perinatal exposure to HIV infection before 18 months of age:
 A mother with documented HIV infection
or
 A confirmed positive test for HIV antibody (e.g., a positive initial
antibody test confirmed by a supplemental antibody test) and a
mother whose infection status is unknown or undocumented
and
o Diagnosis of a stage-3-indicative opportunistic illness (Appendix A)
and
o No subsequent negative result on an HIV antibody test
4.1.3 PEDIATRIC AIDS
• Children who are HIV infected and exhibit any of the following AIDS-defining
clinical conditions should be reported as Stage 3 (AIDS) cases; although most of these
conditions appear among adult AIDS diagnostic criteria, asterisked conditions apply
only to aged <6 years, and conditions with a dagger footnote symbol apply only to
children aged ≥6 years and adults.

34

TG Revised 11/2/2015
• Candidiasis, esophageal
• Cervical cancer, invasive*
• Coccidioidomycosis, disseminated or extrapulmonary
• Cryptococcosis, extrapulmonary
• Cryptosporidiosis, chronic intestinal (>1 month’s duration)
• Cytomegalovirus disease (other than liver, spleen, or nodes)
• Cytomegalovirus retinitis (with loss of vision)
• Encephalopathy, HIV related
• Herpes simplex: chronic ulcer(s) (>1 month’s duration); or bronchitis, pneumonitis, or
esophagitis
• Histoplasmosis, disseminated or extrapulmonary
• Isosporiasis, chronic intestinal (>1 month’s duration)
• Kaposi’s sarcoma
• Lymphoma, Burkitt’s (or equivalent term)
• Lymphoma, immunoblastic (or equivalent term)
• Lymphoma, primary, of brain
• Multiple recurrent bacterial infections†
• Mycobacterium avium complex or M. kansasii, disseminated or extrapulmonary
• Mycobacterium tuberculosis of any site, pulmonary*, disseminated, or extrapulmonary
• Mycobacterium, other species or unidentified species, disseminated or extrapulmonary
• Pneumocystis pneumonia
• Pneumonia, recurrent*
• Progressive multifocal leukoencephalopathy
• Salmonella septicemia, recurrent
• Toxoplasmosis of brain
• Wasting syndrome due to HIV
*Only among adults and children aged ≥6 years.
†

Only among children aged <6 years.

4.1.4 PEDIATRIC SEROREVERTER
• Virtually all children less than 18 months of age born to HIV-infected mothers are
antibody positive at birth.
• A child aged < 18 months born to an HIV-infected mother will be categorized for
surveillance purposes as “not infected with HIV” if the child does not meet the criteria
for HIV infection but meets the following criteria:
3.1: Uninfected
35

TG Revised 11/2/2015
A child aged <18 months who was born to an HIV-infected mother or had a
positive HIV antibody test result is classified for surveillance purposes as not
infected with HIV if the following criteria are met:
• Laboratory criteria for HIV infection are not met (see section 1.2.1)
and
• No diagnosis of a stage-3-defining opportunistic illness (see Appendix A)
attributed to HIV infection
and
• Either laboratory or clinical evidence as described below

3.1.1: Laboratory Evidence
Definitively Uninfected
• No positive HIV NAT (RNA or DNA nucleic acid tests)
and
• At least one of the following two criteria:
o At least two negative HIV NATs from specimens obtained on
different dates, both of which were at age ≥ 1 month and one of
which was at age ≥ 4 months
or
o At least two negative HIV antibody tests from specimens obtained
on different dates at age ≥ 6 months
or
Presumptively Uninfected
• Criteria for definitively uninfected with HIV are not met
and
• At least one of the following four laboratory criteria are met:
o At least two negative NATs from specimens obtained on different
dates, both of which were at age ≥ 2 weeks and one of which was at
age ≥ 4 weeks
or
o One negative nucleic acid (RNA or DNA) test (NAT) from a
specimen obtained at age ≥ 8 weeks
or
o One negative HIV antibody test from a specimen obtained at age ≥ 6
months
or
o If criteria for HIV infection had initially been met by one positive
HIV NAT test then it must have been followed by at least two
negative tests from specimens obtained on different dates, one of
which is
 a NAT test from a specimen obtained at age ≥ 8 weeks or
 an HIV antibody test from a specimen obtained at age ≥ 6
months
36

TG Revised 11/2/2015
•

and
No subsequent positive NAT

3.1.2: Clinical Evidence
• A note written by physician or other qualified medical-care provider states
that the patient is not infected with HIV.

5. RESIDENCE AT DIAGNOSIS
•
•
•
•
•

For reports of HIV infection or perinatal HIV exposure, enter the patient’s city, county,
state/country, and ZIP code of residence at the time of the first confirmatory test for HIV infection
or when HIV infection was first considered, either clinically or through laboratory evaluation.
Documentation of an HIV test is often the earliest evidence that HIV diagnosis was considered,
however, an HIV test may not have been ordered at that time.
If the patient’s residence changes between diagnosis of perinatal HIV exposure and confirmed
HIV infection, record new address.
If laboratory slips are not available, enter the patient’s residence at the date of physician diagnosis
of HIV infection.For HIV, stage 3 (AIDS) case reports, enter patient’s residence at the date of the
first stage 3 (AIDS) diagnosis based on the applicable case definition.
For further guidance about residency assignment, see the file Date and Place of Residence .

7. FACILITY OF DIAGNOSIS
7.2

FACILITY NAME
• For reports of perinatal HIV exposure, enter the name of the facility where child was first
evaluated for HIV infection, either clinically or through laboratory evaluation.
• The hospital where the mother obtained prenatal care should not be used to answer this
question unless it was also the facility where the child was born and HIV infection was
considered as a diagnosis at the time of the child’s birth or at the time of subsequent
physician/clinic visits.
• For reports of confirmed HIV infection, enter the name of the facility where the child was
confirmed to be HIV-infected.
• If test results were not in the medical record, enter the name of the facility where the child’s
HIV infection was diagnosed and documented by the health care provider.Enter facility
uniformly to prevent the occurrence of multiple names for a given facility.
• For HIV, stage 3 (AIDS) case reports, enter the name of the facility where the patient was
first diagnosed with stage 3 (AIDS) based on the applicable case definition.
• These fields strictly apply to facility where HIV or HIV infection stage 3 (AIDS) was
diagnosed. Where chart abstraction is conducted at a facility other than the Facility of
Diagnosis (Section 4), document report source.

8. PATIENT HISTORY
•

This information is often found in the mother’s chart in the discharge summary, history and
physical, social service notes, counseling and testing notes, and STD diagnosis notes.
37

TG Revised 11/2/2015
• Where not explicitly annotated, contact the child’s provider about maternal/child risk factor
information.
• See the file Risk Factor Ascertainment for further guidance on risk factor data collection.This
information can be difficult to find, particularly if the patient has not been interviewed. States
should have risk factor ascertainment procedures tailored to their jurisdictions.
8.1

CHILD’S BIOLOGICAL MOTHER’S HIV INFECTION STATUS
• “Refused HIV testing” should be selected if mother’s refusal is documented in the medical
chart.
• If the biological mother has been tested for HIV and found to be uninfected at or after the
child’s birth, then perinatal transmission is not the presumed mode of exposure to HIV
infection.
• If mother-to-infant transmission through breast-feeding is considered to be the only mode of
transmission, please alert the state or local NIR coordinator, check “Yes” in the “Other
documented Risk”, and provide detail in the Comments section.
(MOTHER) DIAGNOSED WITH HIV INFECTION or Stage 3, AIDS
• If dates are not available, please review medical charts to determine when maternal HIV
diagnosis occurred in relationship to the child’s birth and select:
Known HIV+ before pregnancy;
Known HIV+ during pregnancy;
Known HIV+ sometime before birth;
Known HIV+ at delivery;
Known HIV+ after child’s birth; or
HIV+, time of diagnosis unknown.
• If no information is available regarding maternal HIV status, please select:
HIV status unknown.

8.2

DATE OF MOTHER’S FIRST POSITIVE HIV CONFIRMATORY TEST
• Enter the date of the mother’s first positive test that confirmed HIV infection in mmddyyyy
format using ‘..’ for unknown values (e.g., 03/../2011).

8.5.3 HETEROSEXUAL RELATIONS WITH PERSON WITH HEMOPHILIA/COAGULATION
DISORDER WITH DOCUMENTED HIV INFECTION
• Do not include other bleeding disorders, such as thrombocytopenia, treatable by platelet
transfusion.
• If a transfusion of only platelets, other blood cells, or plasma was received by the partner,
then code “No” and see question 8.5.4 below.
8.5.4 HETEROSEXUAL RELATIONS WITH TRANSFUSION RECIPIENT WITH
DOCUMENTED HIV INFECTION
• Refers to someone with documented HIV infection who received a transfusion of blood cells
(red cells, white cells, platelets) or plasma.
10. CLINICAL
• 10.1.1–10.1.26 (Optional, applies to health department & health care providers)
• Select all that apply and enter diagnosis dates. Enter date in mm/dd/yyyy format using
38

TG Revised 11/2/2015
‘..’ for unknown values (e.g., 03/../2011).
• For additional information, refer to the most recent case definition for HIV infection
(available at http://wwwn.cdc.gov/nndss/conditions/hiv-infection/).
• RVCT CASE NUMBER (Optional, applies to health department & health care
providers).
o If this patient has a verified case of tuberculosis (TB), health department staff
enter the nine-digit alphanumeric code from the TB case report or TB data
management system. Providers in the private and public sectors diagnosing
tuberculosis in their stage 3 (AIDS) patients may get this number from TB
surveillance staff.

11. BIRTH HISTORY (FOR PERINATAL CASES ONLY)
11.4.4 BIRTH DEFECTS
• Data collected will be used to evaluate changes in incidence or other unusual patterns
of serious birth defects among children exposed to zidovudine in utero compared with
those who were not exposed and with the general population.
• Approximately 3%–4% of all babies will have serious birth defects (e.g., neural tube
defects, congenital heart defects, esophageal atresia, and cleft lip/palate).
• The methods and definitions used were developed by the CDC National Center on
Birth Defects and Developmental Disabilities and are currently used in the
Metropolitan Atlanta Congenital Defects Program, an active surveillance system for
birth defects in the Atlanta metropolitan area.
• Select “Yes” if the child meets the case definition for birth defects as defined by the
CDC National Center on Birth Defects and Developmental Disabilities as listed below.
Criteria for Inclusion as Reportable Birth Defect:
• The child must have a structural or genetic birth defect or other specified birth
outcome that can adversely affect his or her health and development;
• The structural or genetic birth defect must be diagnosed or its signs or symptoms
recognized within the first year of life;
• The infant must have a gestational age of at least 20 weeks or a birth weight of
at least 500 grams; and
• A case must be abstracted by the child’s sixth birthday.
Criteria for Exclusion:
• Defects such as normal variants or minor anomalies are considered excludable.
Diagnoses that may be normal variants or minor anomalies may be included
only if associated with another reportable defect.
•

•

Imprecise diagnoses (probable, possible, compatible with, consistent with, suspected,
questionable, suggestive of, etc.) should be abstracted and coded as such and follow-up
conducted to ascertain true status.
For children with possible birth defects, please review newborn and hospital records
including the face sheet; history and physical; discharge summary; operative,
39

TG Revised 11/2/2015
laboratory, x-ray, cardiac catheterization, and autopsy reports; and notes and
consultations by physicians, nurses, and social and psychological services.
• In addition, birth defect (i.e., congenital anomalies) information is also collected on the
standard US birth certificate.
• Hospital records should be reviewed to determine if a reportable defect is present. Each
reportable condition is coded separately according to the birth defect code (see below).
These codes are based on ICD-9 codes but provide more specific diagnostic
information.
• If reportable birth defects are diagnosed, select “Yes” and abstract all diagnoses onto
the case report form.
• Include discrepant diagnoses. Also include diagnoses appearing in the chart that have
not been ruled out by an expert or lab test.
• If the infant is diagnosed with a syndrome, record the name and code of the syndrome
as well as the individual defects.
•

•

•

If there is a question about whether a diagnosis is reportable or how to code any
diagnosis, please call the CDC HIV Incidence and Case Surveillance Branch (HICSB)
at (404) 639-2050. BIRTH DEFECTS CODE
The 6-digit defect codes are based on 3- to 5-digit ICD-9-CM or ICD-10-CM codes
from a birth certificates or medical records (or ICD-9 or ICD-10 codes from death
certificates). The shorter codes may be used in place of the 6-digit codes. Enter the
code for the birth defect given in the birth certificate, medical record, or death
certificate. If the code is not available in those places, but the birth defect is described
using medical terminology, then look up the corresponding code in the ICD-9-CMbased list (downloadable from http://www.cdc.gov/ncbddd/birthdefects/macdp.html) if
the record was from before October 1, 2014, or in the ICD-10-CM-based list
(downloadable from
ftp://ftp.cdc.gov/pub/Health_Statistics/NCHS/Publications/ICD10CM/2014/) if the
record was from October 1, 2014 or later.
If defects exist, list all on the case report form and enter in the Comments section.

11.6.1 GESTATIONAL MONTH PRENATAL CARE BEGAN
• Enter “09” if care began in the ninth month or later.
• If entry is reported in weeks, convert to appropriate months as follows:
Weeks

Months

Weeks

Months

1–4

1

23–26

6

5–9

2

27–30

7

10–13

3

31–35

8

14–17

4

36+

9

18–22

5

11.8 DID MOTHER RECEIVE ANY OTHER ANTIRETROVIRAL MEDICATION DURING
40

TG Revised 11/2/2015
PREGNANCY?
• Clinicians initiating antiretroviral regimens in the HIV-1-infected pregnant patient should
refer to Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected
Women for Maternal Health and Interventions to Reduce Perinatal HIV-1 Transmission in
the United States at https://aidsinfo.nih.gov/guidelines/html/3/perinatal-guidelines/0.
11.10.2

MATERNAL LAST NAME SOUNDEX
• If not already complete, enter the name and date of birth of the patient’s biological
mother in the CDC-supplied software. The SOUNDEX CODE will automatically be
generated based on the biological mother’s surname.
• Retrieve the soundex code from the database and enter here.

12. SERVICES REFERRALS
12.1 NEONATAL ARVs FOR HIV PREVENTION
•
To monitor the implementation and impact of neonatal prophylactic ARV therapy, we
collect the day, month, and year a child was first started on ARV for prophylaxis and the
date of last use.
12.3 ANTI-RETROVIRAL THERAPY FOR HIV TREATMENT
•
Please refer to the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV
Infection https://aidsinfo.nih.gov/guidelines/html/2/pediatric-treatment-guidelines/0#.
12.4 PCP PROPHYLAXIS
•
Please refer to MMWR 1995;44(RR-4):1–11 for the 1995 Revised Guidelines for
Prophylaxis Against Pneumocystis carinii Pneumonia (PCP) for Children Infected with or
Perinatally Exposed to HIV. Examples of PCP prophylaxis include
Trimethoprim/sulfamethoxazole (TMP/SMX, Bactrim, Septra), Pentamidine, and
Dapsone.
•
TMP/SMX (Bactrim, Septra) can be used to treat infections other than HIV but is usually
used for a shorter period. For example, TMP/SMX is used for 2–3 weeks to treat otitis
media and would NOT be recorded as “Yes” in this field.
•
Include as PCP prophylaxis if it is clearly noted as such in the medical chart or given for a
period of 2 weeks or longer.
12.5

WAS THIS CHILD BREASTFED?
• Avoidance of breast-feeding to prevent postpartum transmission of HIV has been
recommended for HIV-infected mothers in the United States.

12.6

THIS CHILD’S PRIMARY CARETAKER IS
• “Other relative” refers to children living with an aunt, grandmother, etc. in an informal
arrangement, and the relative does not receive a stipend for providing care.
•

If a child lives with a relative and that relative is paid a stipend for caring for the child,
“Foster/Adoptive parent, relative” should be selected.

•

A child is in “foster/adoptive parent, unrelated” if living with someone other than a
relative.
41

TG Revised 11/2/2015
• “Adoptive parent, relative” refers to child who has been legally adopted by a relative. This
includes children with deceased parents whose legal custody has been transferred to a
relative.
•

If the adoptive parent is unrelated please select “foster/adoptive parent, unrelated.” This
includes children with deceased parents whose legal custody has been transferred to a
person who is unrelated to the child.

•

“Social service agency” refers to children whose primary caretaker is a social service
agency, which usually refers to children living in group home situations.

•

For children being cared for in situations not described above, select “other” and specify in
this section.

42

TG Revised 11/2/2015
Contents — The Perinatal HIV Exposure Reporting (PHER) form
Purpose of Perinatal HIV Exposure Reporting (PHER) form..................................... 2-44
The exposure reporting form in the context of document-based surveillance .............2-44
Definition of variable designators………………………………………………………….2-44
Disposition of data collection form.............................................................................. 2-44
Chart abstraction guidance…………………………………………………………..……2-44
Qualification of Abstractors………………………………………………………………...2-44
Records to be Abstracted……………..............……………………………..........................2-45
Abstraction of Mother’s Records………………............................................................ 2-45
Abstraction of Infant’s Record............................................................................................. 2-45
Follow-up Chart Review………………… ................................................................... 2-46
Indicating ‘Unknown’……………………….....................................................................2-46
Not Documented……………………….. ..................................................................... 2-46
Dates……………………………….............................................................................. 2-46
Records that are ‘Not Available’….............................................................................. 2-46
Conflicting Information………………………………………………….......................... 2-46
Required Fields………………………………………………………...............................2-46
Questions on the PHER form…….. …...................................................................... 2-47

43

TG Revised 11/2/2015

Technical Guidance for HIV Surveillance Programs — Perinatal HIV
Exposure Reporting (PHER) Form
Instructions for Completion
Purpose of Perinatal HIV Exposure Reporting (PHER) form
The Perinatal HIV Exposure Reporting (PHER) form is used to collect information on perinatal exposure
cases. The form facilitates collection of additional standardized data on HIV-exposed children. This
guidance applies to data collection even if surveillance sites use a different form or medium for HIV case
surveillance. Information on children who are perinatally exposed to HIV or who have HIV stage 3
(AIDS) is protected under a federal assurance of confidentiality.
The exposure reporting form in the context of document-based surveillance
Unlike case-based data management, document-based data management allows all documents to be
stored and retained electronically in their original formats. Instead of completing one form for a given
reported case, fill out the applicable part of the form for each data source contributing to that case.
Definition of variable designators
• Required: Variables that must be collected by all programs.
• Recommended: Variables that programs are strongly encouraged to collect but are not
absolutely required.
• Optional: Variables that programs may or may not choose to collect.
Disposition of data collection form
• The completed PHER form is for state or local health agency use and is not to be sent to the
Centers for Disease Control and Prevention (CDC). The Pacific Islands are the only jurisdictions
that send forms to CDC for data entry and all patient identifiers must be removed before they are
sent.
• Data obtained from these forms are entered into standardized computer software provided by the
Division of HIV/AIDS Prevention, National Center for HIV, Viral Hepatitis, STD, and TB
Prevention, CDC (or other compatible software), linked to maternal records, and then transferred
without identifiers to CDC. Electronic transfers are encrypted via secure data network.
Chart abstraction guidance
Accurate data abstraction is critical. For example, the dates of receipt of prenatal care should be before
the infant’s date of birth. If inconsistent information is found in medical records indicate that in the
Comments section on the data abstraction form. This will serve as documentation that the inconsistency
was in the medical record and is not an error in abstraction, notation, or data entry. The HIV Surveillance
Coordinator in each project area, or their designee, should review all data abstraction forms before the
data are entered.
Qualifications of Abstractors
• Abstractors should be familiar with the components of a medical record (e.g.,
demographic/financial information, doctor’s progress notes, prenatal care records, labor and
delivery records, nurse’s notes, operative notes, lab results, discharge summaries, problem lists,
drug lists, etc.).
44

TG Revised 11/2/2015
• Abstractors should be familiar with medical abbreviations and terminology, especially as related
to HIV.
• Abstractors should be familiar with the procedures required to abstract records from various
providers and facilities.
• Abstractors must be trained in security and confidentiality (S&C) requirements and sign a
statement of compliance. Health departments and academic institutions should have S&C training
requirements and methods in place to document completion of this training.
Records to be Abstracted
At a minimum the following records should be reviewed. Additional records may be reviewed if
available (e.g., STD records, Health Department records).
Mother

Infant

Maternal prenatal records

Pediatric birth records (hospital records)

Maternal labor and delivery records

Birth certificate

Maternal HIV clinic records

Pediatric medical records (HIV clinic, non-HIV
clinic, or other medical records)
Death certificate

Abstraction of Mother’s Records
• All maternal variables refer to information on the infant’s biologic mother.
• If it is not possible to obtain a medical chart for the mother, the PHER form should still be
completed to the extent possible.
• If information on the mother is available in the infant’s chart and also in the mother’s chart, use
the mother’s chart as the primary record for questions related to the mother’s care.
Abstraction of Infant’s Record
• Complete this form only for live births. The definition of a live birth as defined by the World
Health Organization is:
‘...the complete expulsion or extraction from its mother of a product of
conception, irrespective of the duration of the pregnancy, which, after such
separation, breathes or shows any other evidence of life, such as beating of
the heart, pulsation of the umbilical cord, or definite movement of
voluntary muscles, whether or not the umbilical cord has been cut or the
placenta is attached; each product of such a birth is considered live born.’
•
•

Thus, if a birth certificate has been completed for the infant, the record should be abstracted.
If a woman has had several pregnancies during the project period, each pregnancy should be
considered a separate event and should be abstracted separately.
If the outcome of a pregnancy is multiple births (e.g., twins, triplets), a separate eHARS and
supplemental exposure reporting form should be completed for each infant, however the maternal
information need only be abstracted once.

Follow-up Chart Review
45

TG Revised 11/2/2015
Review the pediatric chart at 6 months, 12 months, and 18 months (and at 6 month intervals thereafter if
the child’s infection status is still undetermined). When reviewing the pediatric chart, abstract all data
needed for eHARS updates (e.g., HIV diagnostic tests, CD4 counts, treatment, prophylaxis, AIDSdefining conditions, birthweight, vital status, and birth defects). A new pediatric form should be
completed documenting the updates. On the additional form the demographics section for both the
mother and the infant should be completed as well as those portions of the form that need to be newly
completed or updated. The updated infant’s HIV diagnostic tests, CD4 counts, and viral load test results
should be entered directly into eHARS.
Indicating ‘Unknown’
A ‘99’ should be checked or written to indicate an unknown value for any question. Type of response is
indicated on the form. Unknown should only be checked if the source records are not available.
Not Documented
Responses of ‘Not documented’ should only be checked if the source records are available but there is no
indication in the affirmative or negative for the question being asked.
Dates
All dates on this abstraction form should be written as month/day/year (mm/dd/yyyy) or Month/Year
(mm/yyyy) as indicated on the form. If all or part of a date is unknown, ‘..’ should be entered into the
appropriate space (e.g., 02/../2005). No not use ‘99” to indicate unknown/missing dates. Be sure that the
infant’s date of birth is consistent with the date of delivery and that the dates of receipt of prenatal care,
CD4 and viral load testing, receipt of antiretrovirals, and other data are based on this date of birth.
Records That Are ‘Not Available’
Records will be considered ‘not available’ after two attempts, separated in time, have been made to
review the record. Before a chart is considered ‘not available’, attempt to locate other sites of care where
the chart may be located.
Record not available should only be selected if the information cannot be obtained from any record
source.
Conflicting Information
The medical chart from which a specific question should be answered depends on the question itself. For
example, a maternal obstetrical chart and the HIV chart may have different dates for receipt of prenatal
care. We recommend using information from the obstetrical chart. Similarly, if there are different start
dates for administration of ARV, use the HIV infectious disease (HIV/ID) chart unless the obstetrical
chart documents a good reason to the contrary (e.g., the OB/GYN physician may have also managed the
patient’s antiretroviral therapy). In general, obstetrical information should be pulled from the obstetrical
prenatal or postnatal chart and HIV/ID information should be pulled from the HIV/ID chart.
Required Fields
Infant state number is required on the abstraction form for eHARS data entry and as a quality control tool
to avoid duplicative record entry. All other variables are optional.

1. CHILD ADOPTED OR IN FOSTER CARE (Recommended if applicable, applies to health
department & health care providers).
46

TG Revised 11/2/2015

•
•

Select ‘Yes’ only if the maternal information is not available due to child being adopted, in
foster care or abandoned.
If the maternal information is not available for other reasons, check ‘No’. Else, check ‘Not
applicable’.

2. RECORDS ABSTRACTED (Optional if applicable, applies to health department & health care
providers).

•
•

For each type of record, code whether it was: (1) abstracted; (2) attempted but record was not
available; (3) not abstracted; or (4) attempted, will try again.
Do not simply indicate an X or √ for each record abstracted, rather, use the appropriate number
code.

3. WEEK’S GESTATION AT FIRST PRENATAL CARE VISIT (Required if applicable, applies to
health department & health care providers).

•
•

Enter value in weeks.
A prenatal care visit is the first visit where intake information is obtained. Normally a woman
knows she is pregnant at the time of this first prenatal care visit. A visit to a doctor to confirm
pregnancy status would not be considered the first prenatal care visit unless intake data and
other services typical of the first prenatal care visit are obtained at the time of that confirmation.
Such services would include intake prenatal blood tests, for example. If the woman had been
seen by more than one prenatal care provider, then the date of the visit to the first prenatal care
provider seen should be documented.

47

TG Revised 11/2/2015
4. SCREENING OF MOTHER FOR DISEASE DURING PREGNANCY (Recommended if
applicable, applies to health department & health care providers).

•

Use test done prior to birth but closest to delivery date or at admission for labor and delivery.
4.1

GROUP B STREP (GBS) - Group B streptococci. A major cause of perinatal bacterial
infections and systemic and focal infections in infants. Invasive disease categorized into early
onset (1st week of life) and late-onset (usually at 3-4 weeks of life). Colonization late in
pregnant women and newborns ranges from 5% to 35%. Intrapartum chemoprophylaxis is IV
Penicillin G. Two types of prevention strategies may be used:
• Screening all pregnant women at 35 to 37 weeks for vaginal and rectal GBS colonization
and offering intrapartum chemoprophylaxis to those identified as GBS carriers; or
• Risk factor based strategy - prophylaxis given to women with intrapartum risk factors
including gestation < 37 weeks, ≥ 18 hours since rupture of membrane, or temperature of
38° C or greater.
4.2 HEPATITIS B (Hepatitis B surface antigen, HBsAg) - Detects acutely or chronically infected
persons. Prenatal HbsAg screening of all pregnant women is recommended. Babies of mothers
who are HbsAg (+) must have HBIG and HBV vaccine within 12 hours of birth to prevent
perinatal HBV infection. Be sure the test result is for the surface antigen rather than the
antibody (anti-HBs), core antigen (HbcAg), or antibody (anti-HBc); or Hepatitis B e antigen
(HbeAg) or antibody (anti-HBe). This test is usually done at the initial prenatal visit or at the
time of labor and delivery for high risk women and women whose status is unknown.
4.3 RUBELLA - Screening is usually done at the initial prenatal visit. If ‘negative’ the mother
should be immunized.
4.4 SYPHILIS - All pregnant women should receive serologic screening for syphilis early in
pregnancy with a nontreponemal test (e.g., VDRL and RPR). In addition, screening is
recommended in the third trimester for those in high risk prevalence areas or for women at high
risk. Nontreponemal antibody tests are used for screening purposes and presumptive diagnosis:
VDRL (venereal disease research laboratory); RPR (rapid plasma reagin test; STS serologic test
for syphilis, syphilis screening test); ART (automated reagin test). The nontreponemal antibody
test should be confirmed with a treponemal antibody test (e.g., FTA-ABS, MHA-TP). If a
pregnant woman has a reactive nontreponemal test and a persistently negative treponemal test, a
false positive test is inferred.
(Reference: Red Book 2000- American Academy of Pediatrics).

48

TG Revised 11/2/2015
5. DIAGNOSIS (FOR THE MOTHER) DURING THIS PREGNANCY OR AT TIME OF
LABOR AND DELIVERY (Recommended if applicable, applies to health department & health care
providers).

•

•

•

5.1
5.2

5.3

5.4

5.5

For this question, “diagnosed” refers to newly diagnosed, a recurrence of, or a chronic infection
with any of the following conditions. Screening for syphilis, gonorrhea, and chlamydia is
typically done during prenatal care. Generally, diagnosis of an STD/STI will be documented in
multiple places in the chart including progress notes, a prenatal clinic visit summary sheet (which
should include summary of lab tests for various sexually transmitted diseases), lab results section,
or in sexually transmitted disease summary sheets (typical in public health clinics).
Diagnoses may be presumptive or definitive depending on symptoms and lab tests. If a diagnosis
is made either presumptively or definitively, note the answer as ‘Yes’. Specific criteria for
answering ‘Yes’ to this question are outlined below.
All dates on this abstraction form should be written as month/day/year (mm/dd/yyyy) or
Month/Year (mm/yyyy) as indicated on the form. If all or part of a date is unknown, ‘..’ should be
entered into the appropriate space (e.g., 03/../2011). No not use ‘99” to indicate unknown/missing
dates.
BACTERIAL VAGINOSIS - Clinician diagnosis of bacterial vaginosis. Sometimes abbreviated
BV.
CHLAMYDIA (Chlamydia trachomatis) - Record positive test for chlamydia (a positive
culture, positive EIA, or detection of chlamydial antigen or nucleic acid).
• Name of lab tests - Chlamydia cell culture (TRIC Agent Culture); direct fluorescent
antibody (DFA) tests; enzyme immunoassay (EIA) tests; nucleic hybridization (DNA probe)
tests; and PCR and LCR.
GENITAL HERPES - Active (herpes genitalis) - Primary herpes (first episode of herpes) or
recurrence of herpes during pregnancy or at labor and delivery.
• Name of lab tests - herpes virus culture; herpes cytology (herpetic inclusion bodies,
cytology, inclusion body stain, Tzanck smear, Giemsa stain viral study); rapid diagnostic
tests- direct immunofluorescent AB or EIA; HSV Ag; or polymerase chain reaction (PCR).
GONORRHEA (Neisseria gonorrhea) - Record if culture positive.
• Name of lab tests - Neisseria gonorrhea culture (GC Culture, Gonorrhea Culture); ThayerMartin medium; chocolate agar; detection of nucleic acid.
GROUP B STREP - Group B streptococci. A major cause of perinatal bacterial infections and
systemic and focal infections in infants. Invasive disease categorized as early onset (1st week of
life) and late-onset (usually at 3-4 weeks of life). Colonization late in pregnant women and
49

TG Revised 11/2/2015
newborns ranges from 5% to 35%. Intrapartum chemoprophylaxis is IV Penicillin G. Two
types of prevention strategies may be used:
• Screening all pregnant women at 35 to 37 weeks for vaginal & rectal GBS colonization,
offering intrapartum chemoprophylaxis to those identified as GBS carriers; or
• Risk factor based strategy in which prophylaxis is given to women with intrapartum risk
factors: gestation < 37 weeks, ≥ 18 hours since rupture of membrane, or temperature 38° C
or greater.
5.6 HEPATITIS B (Hepatitis B surface antigen, HbsAg) - Detects acutely or chronically infected
persons. Prenatal HbsAg screening of all pregnant women is recommended. Babies of mothers
who are HbsAg (+) must have HBIG & HBV vaccine within 12 hours of birth to prevent
perinatal HBV infection.
• Be sure the test result is for the surface antigen rather than the antibody (anti-HBs), core
antigen (HbcAg) or antibody (anti-HBc); or Hepatitis B e antigen (HbeAg) or antibody (antiHBe). Tests are usually done at the initial prenatal visit or at the time of labor and delivery
for high risk women and women whose status is unknown.
5.7 HEPATITIS C - Tests do not distinguish between acute, chronic, or resolved infection.
Diagnosis by antibody assays involves initial screening EIA. Repeatedly positive results are
confirmed by a recombinant immunoblot assay (RIBA). Highly sensitive PCR assays for
detection of HCV RNA are also available.
• Name of lab test - EIA (Enzyme immunoassay) screen, confirmed by recombinant
immunoblot assay (RIBA).
5.8 PELVIC INFLAMMATORY DISEASE (PID) - Look for documentation of a clinical diagnosis
of PID. A note stating ‘rule out PID’ does not indicate the woman had PID.
5.9 SYPHILIS (Treponema pallidum) - All pregnant woman should receive a serologic screen for
syphilis early in pregnancy with a nontreponemal test (e.g., VDRL, RPR, STS, and ART) and
preferably again at delivery. In addition, screening is recommended in the third trimester for
those in high prevalence areas or those at high risk.
Nontreponemal antibody tests are used for screening. Any reactive nontreponemal test must be
confirmed by a specific treponemal test (FTA-ABS and MHA-TP) to exclude false positive
results which can be caused by a viral infection (e.g., infectious mononucleosis, hepatitis,
varicella and measles), lymphoma, TB, malaria, endocarditis, connective tissue disease,
pregnancy, or abuse of injection drugs. If a pregnant woman has a reactive nontreponemal test
and a persistently negative treponemal test, a false positive test is inferred. A positive FTAABS or MHA-TP usually remains reactive for life, even after successful therapy. Also, look for
evidence of treatment for syphilis - receipt of penicillin (bicillin) 2.4 million units is the standard
treatment for syphilis in the mother. Check whether the child was diagnosed with or treated for
congenital syphilis with penicillin for 10 days. A physician diagnosis will be clearly
documented in the infant's birth chart. Also check the congenital syphilis registry to confirm
congenital syphilis, with consideration for confidentiality and security of an individual’s HIV or
stage 3 or AIDS status.
• Name of lab tests - Presumptive diagnosis: nontreponemal tests (for screening purposes)
VDRL (venereal disease research laboratory); RPR (rapid plasma reagin test, serologic test
for syphilis, STS, syphilis screening test, ART-automated reagin test). Definitive diagnosis:
treponemal tests (for diagnostic purposes) Darkfield examination (Darkfield microscopy,
syphilis; Treponema Pallidum Darkfield examination); FTA-ABS (Fluorescent Treponemal
Antibody Absorbed Test, Fluorescent Treponemal Antibody Adsorption); MHA-TP
(Microhemagglutination assay for Antibody to Treponema Pallidum;
50

TG Revised 11/2/2015
Microhemagglutination, Treponema Pallidum.
5.10 TRICHOMONAS (Trichomonas vaginalis) - Record clinician diagnosis of trichomonas.
Trichomonas is diagnosed by finding trichomonas on a wet mount.
• Name of lab tests - Trichomonas preparation (Hanging Drop Mount for Trichomonas,
Trichomonas vaginalis wet preparation; Trich Prep; wet preparation for Trichomonas
vaginalis.
6. MOTHER’S REPRODUCTIVE HISTORY (Optional if applicable, applies to health department
& health care providers).

An obstetrical history should be documented at the first prenatal visit in the progress notes section or
the prenatal care flow sheet. The obstetrical history should list the outcome of all the woman’s past
pregnancies.
6.1

NUMBER OF PREVIOUS PREGNANCIES: This number should include all pregnancies,
regardless of outcome (e.g., including abortions and miscarriages) up to but EXCLUDING the
pregnancy that is being abstracted.
6.2 NUMBER OF PREVIOUS LIVE BIRTHS: The number of live births is the total preterm and
term births (excluding abortions, miscarriages, and stillbirths). Note that parity (commonly
reported in medical charts) refers to the number of viable pregnancies, that is, the number of
pregnancies carried to 20 weeks. Parity excludes miscarriages and elective abortions but
includes stillbirths. Parity cannot be used for this answer.
6.3 NUMBER OF PREVIOUS MISCARRIAGES: A miscarriage is an abortion which occurs
naturally and may also be referred to as a ‘spontaneous abortion’ (SAB). A spontaneous
abortion is a fetal death that occurs before 20 weeks (a stillbirth is a fetal death that occurs at or
after 20 weeks). Record the number of miscarriages.
6.4 NUMBER OF PREVIOUS INDUCED ABORTIONS: An ‘induced’ abortion is brought on
purposely and may also be known as an ‘artificial’ or ‘therapeutic’ abortion (TAB), or referred
to as a ‘termination of pregnancy’ (TOP). In cases where the woman has had an abortion, the
chart may abbreviate this as ‘A’ or ‘Ab’ or ‘TAB’ or ‘TOP’ followed by a number designating
the number of abortions prior to this pregnancy. Record the number of induced abortions.
•

The medical record does not always differentiate spontaneous from elective
abortions. In those cases the only data available is ‘total’. Number of total abortions:
spontaneous abortion + elective abortion = total. The total number of abortions is usually
noted at intake at the time of the first prenatal care visit in the obstetrical history. If the
provider documented parity as a four-digit number, the third digit (number of pregnancies
ending in abortion) can be used to answer this question. Remember to record the number of
previous induced abortions (above) AND the number of previous miscarriages (above) OR
(if the chart does not break these two categories out) the total number of abortions, but not
both.

Note on G_P_ Abbreviations In the Medical Record: This information is often written in the
following format: G _ P_, as in G5 P3 or it may be written as G5P3A1. The ‘G’ (gravida) refers to the
51

TG Revised 11/2/2015
total number of pregnancies (including current pregnancy), the ‘P’ (para) to the number of live births
(at least 20 weeks gestation) and the ‘A’ to the number of induced and spontaneous abortions.
Information on gravida status is usually noted at intake at the time of the first prenatal care visit. Also
note that ‘multigravida’ refers to a woman who has been pregnant more than once, ‘primigravida’
refers to a woman who is pregnant for the first time (by definition, has no prior pregnancies), and a
‘grand multiparous’ woman refers to a woman who has had more than 5 pregnancies.
• G = gravida, the number of pregnancies including the current pregnancy;
• P = parity, the number of pregnancies > 20 weeks gestation (excludes miscarriages and 1st
trimester abortions); and
• A = Abortion, the number of abortions (both spontaneous and induced abortions).
For example, a woman who is G5 P3A1 has been pregnant 5 times (including the current pregnancy), 3
of those pregnancies were carried to at least 20 weeks gestation, and she had 1 spontaneous or
induced abortion.
Parity may also be documented as a four digit number. The first digit represents the number of
pregnancies delivered at full-term (at least 37 weeks gestation). The second digit represents the
number of pregnancies delivered pre-term (20-37 weeks). The third digit represents the number of
abortions including spontaneous or therapeutic abortions; and the last digit represents the number of
living children the woman currently has.
P = parity may be documented as a 4 digit number:
1st digit = term pregnancies (>37 weeks);
2nd digit = preterm pregnancies (20-37 weeks);
3rd digit = abortions (includes both spontaneous and induced abortions); and
4th digit = living children
For example, a woman’s record may read G5 P2113. This woman has delivered 2 infants who were fullterm, delivered one infant pre-term, had one abortion and has 3 living children. This patient is
currently pregnant (total number of pregnancies=5) and she has had four previous pregnancies.
If you are using G_P_ notation to complete Q.6, remember that you will have to subtract the current
pregnancy from the gravida (G) notation.
This format is not always followed exactly as described here. When possible, it will be useful to ask
clinic nurses what their standard notation is.

52

TG Revised 11/2/2015
7. COMPLETE THE CHART FOR ALL SIBLINGS (Recommended if applicable, applies to health
department & health care providers).

•
•

If possible, record the dates of birth and/or age in years and months of live born siblings.
Indicate the current serostatus of the sibling and the STATENO and the CITYNO. This
information is not always available on prenatal care charts or labor and delivery records.

8. SUBSTANCE USE DURING PREGNANCY (Recommended if applicable, applies to health
department & health care providers).

This section provides information on whether substance use occurred during the mother’s pregnancy.
This information is typically found in the progress notes, social worker notes, lab results summary
section, or in the summary sheet listing all prenatal care visits, lab results, gestational ages, and other
information.
8.1 WAS SUBSTANCE USED DURING PREGNANCY?
•
•
•
•
•
•

Indicate whether substances were used during pregnancy by selecting “Yes”, “No”, “Record
not available”, or “Unknown”.
If ‘Yes’, indicate which substances were used. The drugs listed here are in alphabetical order
and may be checked if there is evidence of a toxicology screen or a notation in records not
based on a toxicology screen (e.g., patient self-report).
Heroin is a semisynthetic narcotic and opiate and should be listed as heroin, opiate, or opioid
on the urine toxicology lab results sheet.
Marijuana may be listed on the urine toxicology results as cannabis, a cannabinoid, THC or
simply marijuana.
Methadone is a synthetic narcotic and should be listed as methadone. Any methadone use,
whether legal or illegal, should be included as ‘Yes’ to this question.
If ‘Other’, be sure to specify the name of the drug(s) used.
53

TG Revised 11/2/2015
8.2 IF SUBSTANCE USED, WERE ANY INJECTED?
• If ‘Yes’, write the name of the drug in the space provided.
9. WAS TOXICOLOGY SCREEN DONE ON MOTHER? (Recommended if applicable, applies to
health department & health care providers).

•
•
•
•
•
•
•
•
•
•
•

Check ‘Yes, positive result’ for any drug testing positive and indicate the drug resulting in the
positive test.
Check ‘Yes, negative result’ if a screen was conducted and all drugs tested for were negative.
Check ‘No’ if it is known that a screen was not conducted.
Otherwise check ‘Toxicology screen not documented’ if no testing or results are documented in
any records.
The toxicology testing must have been completed during pregnancy, not before pregnancy.
Toxicology screens are usually done using urine or serum and are usually listed as ‘positive’ if
there is evidence of the drug in the urine or blood serum.
Heroin is a semisynthetic narcotic and opiate and should be listed as heroin, opiate, or opioid on
the urine toxicology lab results sheet.
Marijuana may be listed on the urine toxicology results as cannabis, a cannabinoid, THC or
simply marijuana.
Methadone is a totally synthetic narcotic and should be listed as methadone. Any methadone use,
whether legal or illegal, should be included as ‘Yes’ to this question.
If ‘Other’, be sure to specify the name of the drug(s) used.
Select the appropriate response(s) from given legal values. If screening for ‘Other’ drug was
done, be sure to indicate what the drug was in the space provided.

54

TG Revised 11/2/2015
10. TOXICOLOGY SCREEN ON INFANT AT BIRTH (Recommended if applicable, applies to
health department & health care providers).

•
•
•
•

Most toxicology screens on infants are done using urine. A positive screen at birth indicates illicit
maternal drug use before delivery. This information should be noted in the infant's birth chart.
See toxicology report interpretation in section 9 above.
Select all drugs identified on screening, including methadone.
If screening for ‘Other’ drug was done, specify the drug metabolites in the space provided.

11. MOTHER’S HIV SEROSTATUS (Required if applicable, applies to health department & health
care providers).

•
•
•

This information may be found in the history or progress notes, or on a lab report.
Select “No” if there is evidence of prenatal care but no indication that an HIV test was conducted.
If no prenatal care was received, indicate “No prenatal care”.

55

TG Revised 11/2/2015
12. ANTIRETROVIRAL DRUGS PRESCRIBED FOR MOTHER (Required if applicable, applies to
health department & health care providers).

12.1 WERE ANTIRETROVIRAL DRUGS WERE PRESCRIBED FOR THE MOTHER DURING
THIS PREGNANCY?
• ‘During this pregnancy’ refers to the time up to, but not including, labor and delivery.
• Select ‘yes’ if the mother was previously taking, began taking, or restarted antiretroviral
medications after interruption during the 1st trimester. See section 12.2 for instructions on
coding individual drugs.
• Select ‘no’ if no ARV was prescribed during this pregnancy. See section 12.3 for instructions
on coding why no ARV was prescribed.
12.2 IF ‘YES’, ANTIRETROVIRAL DRUGS PRESCRIBED FOR THE MOTHER DURING THIS
PREGNANCY.
• DRUG NAME - Note all antiretrovirals either used or refused during the pregnancy.
COMBIVIR is a combination of ZDV (AZT) and 3TC. If combivir is discontinued during
pregnancy but either ZDV (AZT) or 3TC (lamivudine) is continued, code Combivir as stopped
and indicate that ZDV or 3TC was begun (as a single drug) and the date this change was
made. If the woman received drug therapy as part of ACTG 316, receipt of NEVIRAPINE
should not be indicated on the antiretroviral drug chart since it is not known whether the
mother received the drug or the placebo. If the specific drugs she received or refused are
unknown, complete the grid and write ‘Unknown” in the ‘Drug Name’ column. Also, enter
the receipt of ARVs during pregnancy in eHARS.
• DRUG REFUSED - If any antiretroviral drug was refused, write the name of the drug in the
grid and check the column labeled ‘Drug Refused’. Do not assume that a woman who did not
receive antiretroviral drugs refused the drugs; she may not have been offered ARV
medications. Only code ‘refused’ if refusal is documented. This is asked to distinguish
between women who were not prescribed drugs because they were not offered and those who
were not prescribed drugs because they refused them.
• DATE DRUG STARTED - Enter the date the drug was started in mmddyyyy format using ‘..’
for unknown values (i.e., 03/../2011). In the case of a woman having interrupted antiretroviral
56

TG Revised 11/2/2015
medications due to pregnancy, the column ‘Date Started’ refers to the date when the mother
initially started the antiretroviral drugs.
• GESTATIONAL AGE STARTED - Enter week of gestation antiretrovirals were started.
Round down to the nearest completed week of gestation (e.g., if the medical chart indicates 37
4/7 weeks then round to 37 weeks). In the case of a woman having interrupted antiretroviral
medications due to pregnancy, the column ‘Gestational Age Started’ refers to the gestational
age when the mother initially started the antiretroviral drugs. If the week is unknown then
indicate ‘99’ for Unknown.
• DRUG STOPPED - If the drug was stopped (discontinued) prior to the birth of the infant but
administered sometime during the pregnancy, indicate ‘Yes’, the drug was stopped. Enter
‘ND’ if it is not documented.
• DATE STOPPED - Enter date the antiretrovirals were stopped (if completely discontinued) in
mmddyyyy format using ‘..’ for unknown values (i.e., 03/../2011).
• DRUG STOP CODE - To answer this question, use the stop codes found at the end of the
abstraction form. Up to two codes are allowed. If there are more than two reasons why a drug
is stopped, indicate the two most important reasons. Code the reasons as they are written in
the physician’s notes. Do not attempt to provide reasons if they are not clearly documented in
the chart. If a woman interrupts use only temporarily, for example while she is in the first 3
months of pregnancy and then restarts, do not code as stopped.
• Enter ‘Unknown’ in the ‘Drug Name’ column if the specific drugs she received are unknown.
12.3 IF NO ARV WAS PRESCRIBED IN PREGNANCY, INDICATE REASON:
• NO PRENATAL CARE - The mother did not receive any prenatal care during her pregnancy.
• HIV STATUS OF MOTHER UNKNOWN - The physician may not have known the HIV
status of mother because she refused testing or the physician did not offer testing. Sometimes
the mother is not identified as being HIV positive until after delivery.
• MOTHER KNOWN TO BE HIV NEGATIVE DURING PREGNANCY - If the mother tested
HIV negative during pregnancy (with no further testing to indicate HIV seroconversion), she
would not receive ARV for prevention of perinatal transmission. There must be evidence of a
negative test during pregnancy in the chart; do not use patient report.
• MOTHER REFUSED - Mother refused ARV during pregnancy.
• OTHER - If ‘Other’ is indicated, be sure to specify why ARV was not prescribed.
• NOT DOCUMENTED - Indicate ‘Not Documented’ if the woman was not prescribed ARV
but the reason why is not known.
13. WAS MOTHER’S HIV SEROSTATUS NOTED IN HER LABOR AND DELIVERY
RECORDS? (Required if applicable, applies to health department & health care providers).

•

Select ‘Yes, HIV-Positive’ if there is explicit reference to her positive HIV status in the chart
(including receipt of ARV). For the majority of women tested before or during pregnancy, the
answer here is ‘Yes, Positive’. For some patients the HIV test date may not be documented at all.
The chart should indicate, however, she was known to be HIV-infected during her pregnancy. In
such cases, check ‘Yes, HIV-positive’.
57

TG Revised 11/2/2015
• Select ‘Yes, HIV-negative’ if there is explicit reference to her negative HIV status in the chart.
This must be evident by the presence of a negative test result.
• Select ‘No’ if:
• The progress notes in the prenatal records state that this is a woman at risk for HIV infection
but that her HIV infection status is unknown.
• The woman may have been tested before delivery, but appears not to be known to be HIVinfected by medical staff include: being tested so late in pregnancy that results are not
available before delivery, failure of physicians to inquire about HIV status, failure to be
offered a test during prenatal care, and failure of patient to disclose.
14. DID MOTHER RECEIVE ANTIRETROVIRAL DRUGS DURING LABOR AND
DELIVERY? (Required if applicable, applies to health department & health care providers).

The labor and delivery period is also termed the intrapartum period and refers to the time from which
the woman was admitted to the hospital for labor to the time of delivery.
14.1 Select appropriate response from given values of “Yes”, “No”, “Not documented”, “Record not
available”, and “Unknown”.
• Select ‘Yes’ if ARVs received during the intrapartum period, and complete the table for all
drugs received during labor and delivery. Enter “Unknown” in the ‘Drug Name’ column if
the specific drugs received are unknown.
• Enter the date the drug was started in mmddyyyy format using ‘..’ for unknown values
(e.g., 03/../2011). Write time in military hours (e.g., 9:15 a.m. is 09:15, 1:00 p.m. is
13:00). Midnight is 00:00 and noon is 12:00. To calculate military time count the
number of hours and minutes past midnight or 00:00 hours. Indicate if the drug was
administered orally, through IV, or not documented.
58

TG Revised 11/2/2015
• Select “No” if no ARV was received during labor & delivery, and indicate reason from the
following given legal values:
• Precipitous delivery/STAT C-section - In some cases an eminent delivery of an infant
may preclude prescription and/or administration of ARV.
• Prescribed but not administered - There are instances where a physician has ordered the
medication, but the mother never received it. Possible reasons would include not
having the specific ARV in the hospital pharmacy. If the ARV was prescribed but not
administered because the women delivered prior to administration, check the previous
box for ‘Precipitous delivery/STAT c-section’.
• HIV serostatus of mother unknown - The physician may not have known the HIV status
of mother either because she refused testing or the physician did not offer testing.
Sometimes the mother is not identified as being HIV positive until after delivery.
• Birth not in hospital - If the birth occurred outside a hospital, in all likelihood ARV
would not have been administered.
• Mother tested HIV negative during pregnancy - Some women may become HIV
positive during pregnancy. The mother may have tested HIV negative at some point
during pregnancy and was never retested and determined to be HIV positive. In this
case she may not have been prescribed ARV during labor and delivery because she was
believed to be HIV negative. There must be evidence of a negative test during
pregnancy or at labor and delivery in the chart; do not use patient report.
• Mother Refused - Mother refused ARV at labor and delivery.
• Other - If ‘Other’ is indicated, be sure to specify why ARV was not prescribed.
• Select “Not Documented” if the woman was not prescribed ARV but the reason why is not
known.
• Drug Refused - If any antiretroviral drug was refused, write the name of the drug in the grid
and check ‘Yes’ in the column labeled ‘Was Drug Refused’. Do not assume that a woman
who did not receive antiretroviral drugs refused the drugs - they may not have been offered.
Only code ‘refused’ if refusal is documented. Our goal is to sort out women who did not
receive drugs because it was not offered to them, and those who did not receive it because
they refused it.
15. WAS MOTHER REFERRED FOR HIV CARE AFTER DELIVERY? (Recommended if
applicable, applies to health department & health care providers).

Indicate if the mother was referred for HIV care after delivery. An indicator for this could be a CD4 or
viral load test after the mother’s discharge from the hospital following delivery of the infant. This
information is usually found in the mother’s chart. If not, indicate ‘Not documented’.
16. IF YES, INDICATE FIRST CD4 OR FIRST VIRAL LOAD RESULT AFTER DISCHARGE
FROM THE HOSPITAL (UP TO 6 MONTHS AFTER DISCHARGE). (Required if applicable,
applies to health department & health care providers).

59

TG Revised 11/2/2015

This question is most relevant for those project areas that have laboratory reporting of CD4 counts and
viral loads. If the mother receives CD4 or viral load testing this information can be used as a marker that
the mother has received care after delivery.
• Indicate the first CD4 count and percentage and the first viral load result following the mother’s
discharge from the hospital (after delivery of the infant). This information will most likely be
found in the mother’s clinic chart. If there is no indication of a subsequent CD4 or viral load
result, mark ‘Not done’.
• See the PCRF, Section 9 above, for instructions on coding CD4 and viral load results.
17. BIRTH INFORMATION. (Required if applicable, applies to health department & health care
providers).

This information may be listed in the labor and delivery record or in a dictated/transcribed labor and
delivery summary by the physician. Write time in military hours (e.g., 9:15 a.m. is 09:15, 1:00 p.m. is
13:00). Midnight is 00:00 and noon is 12:00. To calculate military time count the number of hours and
minutes after midnight or 00:00 hours. Enter the date in mmddyyyy format using ‘..’ for unknown values
(e.g., 03/../2011).
• Onset of labor - This should be found on the labor and delivery summary sheet. The onset of
labor is defined as the time when contractions are 3-5 minutes apart. The date and time are
necessary to calculate the duration of ruptured membranes, and duration of labor. In an
‘elective cesarean section’ there will not be onset contractions, because by definition, an
elective cesarean occurs prior to onset of labor. In this case, write ‘none’ in the space
provided.
• Admission to Labor and Delivery - Time of admission should be available on the face sheet
(likely stamped on this sheet). If possible, record the time of admission to Labor and Delivery
(L&D), rather than to hospital. A short time between admission and delivery (‘precipitous
delivery’) may be a reason for not receiving ARVs. You should make sure that the date and
time of admission to L&D is for the admission associated with delivery. The woman may
have been admitted on another date and/or time for false labor or some other reason and sent
home, then readmitted for delivery.
• Rupture of membranes - This should be found on the labor and delivery summary sheet.
The date and time are necessary to calculate the duration of ruptured membranes and duration
60

TG Revised 11/2/2015
of labor. Rupture of membranes refers to the time when the amniotic sac is either purposely
broken or ruptures on its own. When a physician/health care provider ruptures the membranes
this is referred to as artificial rupture of membranes--often abbreviated as AROM. When
membranes rupture on their own, spontaneously, this is referred to as spontaneous rupture of
membranes (SROM). Premature rupture of membranes is referred to as PROM. In the case of
cesarean section, the rupture of membranes may be almost concurrent with time of delivery.
• Delivery - This should be found on the labor and delivery summary sheet. The date and time
are necessary to calculate the duration of ruptured membranes and duration of labor. If the
time of delivery is unknown because of a home or out-of-hospital delivery, enter ‘..:..’. Verify
that the delivery date is the same as the date of birth noted on the first page of the abstraction
form. If there is an inconsistency, verify the correct date of birth and update eHARS if
necessary.
18. BIRTH INFORMATION. (Required if applicable, applies to health department & health care
providers).

•

•

•

Mode of delivery information should be noted in the delivery summary sheet, nurse’s notes,
anesthesiologist’s notes, or physician’s progress notes. Often there is a standard check off list of
procedures that may have been performed in the course of labor and delivery. A cesarean
delivery may be noted there.
Elective cesarean section refers to a cesarean section that occurs before rupture of membranes
and before the onset of labor. If a cesarean section was planned but then performed ahead of
schedule due to unexpected circumstances, it should still be coded as ‘Elective.’ Non-elective (or
emergent) C-sections are usually done because the fetus has shown signs of distress during labor.
Elective C-sections are planned, done for a variety of reason (e.g., previous C-section, breech
position, HIV prevention) and usually occur before the onset of labor. C-sections that are done in
the middle of the night are usually not elective. Review the chart for clarification if summary
sheet indicates ‘elective’. Whether a C-section was elective or emergent may not be noted in the
delivery summary sheet, but the dictated discharge summary will make this clear. The reason(s)
for a C-section are given in the labor and delivery medical record. Notes in the child’s records
are acceptable even if no birth records are available.
If not documented, select ‘Not specified’.

19. WAS THE MOTHER’S HIV SEROSTATUS NOTED ON THE CHILD’S BIRTH RECORD?
(Recommended if applicable, applies to health department & health care providers).

61

TG Revised 11/2/2015
Select appropriate response from given values.
20. ANTIRETROVIRAL DRUGS PRESCRIBED FOR THE CHILD. (Required if applicable,
applies to health department & health care providers).

•

•
•

•

Select “Yes” if any ARVs were prescribed for the child in the first 6 weeks of life, and complete
the grid.
• Enter the dates in mmddyyyy format using ‘..’ for unknown values (e.g., 03/../2011). Write
time in military hours (e.g., 9:15 a.m. is 09:15, 1:00 p.m. is 13:00). Midnight is 00:00 and
noon is 12:00. To calculate military time count the number of hours and minutes after
midnight or 00:00 hours.
Enter all ARVs for the child (not just the first 6 weeks of life)
If no ARV prescribed during first 6 weeks, indicate reason
• HIV serostatus of mother unknown - The physician may not have known the HIV status of
mother either because she refused testing or the physician did not offer testing. Sometimes the
mother is not identified as being HIV positive until after delivery.
• Mother known to be HIV negative during pregnancy - If the mother tested HIV negative
during pregnancy (with no further testing to indicate HIV seroconversion), she would not
receive ARV for prevention of perinatal transmission. There must be evidence of a negative
test during pregnancy or at labor and delivery in the chart; do not use patient report.
• Mother Refused - Mother refused ARV for infant during first six weeks of life.
• Other - If ‘Other’ is indicated, be sure to specify why ARV was not prescribed.
• Not Documented - Indicate ‘Not Documented’ if the infant was not prescribed ARV but the
reason why is not known.
Select “Unknown” if the specific drugs prescribed are unknown, complete the grid, and write

62

TG Revised 11/2/2015
“Unknown” in the “Drug name” column.

63


File Typeapplication/pdf
File TitleTechnical_Guidance_vol2.book
Authorbnk5
File Modified2015-11-16
File Created2015-11-16

© 2024 OMB.report | Privacy Policy