Attachment 4(b)
National HIV Surveillance System (NHSS)
OMB # 0920-0573
Pediatric HIV Confidential Case Report Form Technical Guidance
Including Perinatal HIV Exposure Reporting (PHER)
29 October 2012
1
Technical Guidance for
HIV Surveillance
Programs
Pediatric HIV Confidential Case
Report Form
HIV Incidence and Case Surveillance Branch
Atlanta, Georgia
1
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 .......................................................................................... 2-3
Section I, Patient identification.............……………………………..........................2-4
Section II, Health department use only........................................................... 2-5
Section III, Facility providing information............................................................... 2-6
Section IV, Patient demographics ................................................................... 2-7
Section V, Residence at diagnosis...................................................................2-9
Section VI, State/local use only ..................................................................... 2-10
Section VII, Facility of Diagnosis…………………………………………………..2-11
Section VIII, Patient history............................................................................ 2-12
Section IX, Laboratory data............................................................................. 2-16
Section X, Clinical……………………………………………….......................... 2-20
Section XI, Birth history (Required for perinatal cases only).......................... 2-21
Section XII, Services referral …..................................................................... 2-24
Section XIII, Comments, Local/optional fields............................................... 2-26
Appendix: Pediatric HIV Confidential Case Report (CDC 50.42B).................... 2-27
Instructions for Completion ........................................................................... 2-27
Purpose .................................................................................................... 2-27
Pediatric Cases of Public Health Importance (COPHI) ............................ 2-28
Section I, Patient identification ……………………………….. ................... 2-28
Section II, Health department use only .................................................... 2-28
Document Source Codes for HIV/AIDS Reporting .............................. 2-28
Section IV, Patient demographics............................................................ 2-32
Section V, Residence of Diagnosis........................................................... 2-37
Section VI, State/local use only................................................................ 2-37
Section VI, Facility of Diagnosis…………………………………………….…2-37
Section VIII, Patient history........................................................................ 2-38
Section IX, Laboratory data...................................................................... 2-40
Section X, Clinical……….......................................................................... 2-40
Section XI, Birth history (for perinatal cases only).................................... 2-40
Section XII, Services Referral ……………………..................................... 2-40
2
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 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 optional. This guidance applies to
this data collection even if surveillance sites use a different form or medium for HIV case surveillance.
See Appendix for further details.
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 given reported case, fill
out the applicable part of the form for each data source contributing to that case.
Patients for whom form is indicated
• Each child with confirmed HIV infection and those who meets the pediatric AIDS case definition.
• In areas with confidential perinatal exposure HIV reporting, all children born to HIV-infected
mothers.
• Includes children whose infection status has not yet been determined, seroreverters, and those
exposed but determined not to be infected with HIV; inclusion of such patients is for public
health surveillance purposes only.
• A federal assurance of confidentiality applies to information on children exposed perinatally with
or without consequent infection.
• Each person with HIV infection who has been reported but for which updated information is
available such as new CD4 or viral load tests reported from a medical provider, additional risk
factor information, or updated current address information.
• If the data is collected electronically and can be imported, recording the information on a form is
not necessary.
Definition of variable designators
• Required: Variables that must be collected by all sites.
• Recommended: Variables that sites are strongly encouraged to collect but are not absolutely
required.
• Optional: Variables that sites may or may not choose to collect.
Disposition of form
• The completed form is for state or local health agency use and is not to be sent to the Centers for
Disease Control and Prevention (CDC) with patient identifiers. The Pacific Islands are the only sites
that send forms to CDC for data entry and all patient identifiers should be removed before they are
sent.
• Data obtained from these forms are entered into compatible or standardized computer software
provided by the Division of HIV/AIDS Prevention, National Center for HIV, Viral Hepatitis, STD,
3
and TB Prevention, CDC, and then transferred without identifiers to CDC electronically by
encrypted electronic transfer via secure data network.
•
Patient Identification
*Information NOT transmitted to CDC
Patient identifier information is for state/local health department use only and is not transmitted to CDC.
Enter the data below for all persons being reported with HIV.
1.1
PATIENT NAME (Required, applies to Health Dept & Health Care Providers)
•
Enter patient’s first name, middle name, and last name.
1.2
LAST NAME SOUNDEX (Required, applies to Health Dept & Health Care Providers)
• After patient name is entered into CDC-supplied software, the software generates this variable by
using the patient’s last name. After the code is automatically generated, health department staff
should fill 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.
1.3
ALTERNATE NAME TYPE (Optional)
• If available, write in the alternate name type (such as Birth, Call Me) and patient’s alternative first
name, middle name, and last name.
1.4 ADDRESS TYPE (Required, applies to Health Dept & Health Care Providers)
• Select one of the address types (residential, bad address, correctional facility, foster home,
homeless, postal, shelter, or temporary) for the patient’s current address.
1.5
CURRENT STREET ADDRESS (Required, applies to Health Dept & Health Care Providers)
• Enter the patient’s current street address.
1.6
PHONE (Required if patient has a telephone, applies to Health Dept & Health Care Providers)
• Enter patient’s current home area code and telephone number.
1.7
CITY (each element Required, applies to Health Dept & Health Care Providers)
•
Enter patient’s current city
1.8 COUNTY (each element Required, applies to Health Dept & Health Care Providers)
• Enter patient’s current county
1.9
STATE/COUNTRY (each element Required, applies to Health Dept & Health Care Providers)
• Enter patient’s current state/country
4
1.10 ZIP CODE COUNTY (each element Required, applies to Health Dept & Health Care Providers)
• Enter patient’s current zip code
1.11 MEDICAL RECORD NUMBER
• Enter medical record number of the patient if available.
• Refer to Appendix 1.11 for further guidance.
1.12–1.13 OTHER ID TYPE AND NUMBER
• Enter any additional patient’s ID type (such as social security number) and the number of the other
ID. For a list of ID type’s, please reference the eHARS Technical Reference Guide.
•
Health Department Use Only
DATE RECEIVED AT HEALTH DEPARTMENT (Optional)
• Enter date in mmddyyyy format.
2.2
eHARS DOCUMENT UID
• Enter UID after CDC-supplied software generates this variable.
2.3
STATE NUMBER (Required)
• 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 the state datasets without duplication.
2.4
REPORTING HEALTH DEPARTMENT -CITY/COUNTY
• Enter name of city and county of the health department that receives the report from providers of
surveillance data.
2.5
CITY/COUNTY NUMBER
• 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 Dept)
• 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.
• If coding proves difficult, write in document source for later coding.
5
•
2.7
2.8
SURVEILLANCE METHOD (Required)
• Enter the method the case report was ascertained- active, passive, follow up, reabstraction or
unknown.
• For definitions of active, passive, follow up, re-abstraction refer to Volume 1 of the Technical
Guidance for HIV Surveillance Programs —Access to Source Data, Case Finding and
Completeness of Reporting.
DID THIS REPORT INITIATE A NEW INVESTIGATION? (Optional)
• Enter whether this case report initiated a new investigation by the health department- yes, no or
unknown.
2.9
•
Refer to Appendix 2.6 for code information.
REPORT MEDIUM (Optional)
• Health department staff review medical records at provider sites or receive information over the
telephone, by fax, e-mail, US mail, etc. 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. Choose one of the following options: Field visit,
mail, fax, phone, electronic transfer or CD/Disk.
Facility Providing Information
3.1
FACILITY NAME (Optional, applies to Health Dept & Health Care Providers)
• Enter name of the facility providing the information.
• If HIV, stage 1-2 or 3(AIDS) were reported from different facilities, enter name of each on
separate forms, specifying which occurred at which facility.
3.2
PHONE (Optional, applies to Health Dept & Health Care Providers)
• Enter facility’s current area code and telephone number.
3.3
STREET ADDRESS (Optional, applies to Health Dept & Health Care Providers)
• Enter facility’s street address.
3.4
CITY (Optional applies to Health Dept & Health Care Providers)
• Enter city where facility providing information is located.
3.5 COUNTY (Optional applies to Health Dept & Health Care Providers)
• Enter county where facility providing information is located.
3.6
STATE/COUNTRY (Optional, applies to Health Dept & Health Care Providers)
• Enter state, country name where facility providing information is located.
6
3.7
ZIP CODE (Optional, applies to Health Dept & Health Care Providers)
• Enter ZIP code where facility providing information is located.
3.8
FACILITY TYPE (Required, applies to Health Dept & Health Care Providers)
• Select applicable response corresponding to the type of facility providing information
• Refer to Appendix 7.9 for further details.
3.9
DATE FORM COMPLETED (Required, applies to Health Dept & Health Care Providers)
• Enter date in mmddyyyy format.
3.10 PERSON COMPLETING FORM (Optional, applies to Health Dept & Health Care Providers)
• Enter the name of the person completing the form who can be contacted to clarify entries and
supply additional information.
3.11 PHONE (Optional, applies to Health Dept & 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 Dept & Health Care Providers)
• Select applicable response.
• Irrespective of the interval between diagnostic status dates, and even where the same source of
these data reported more than one event, use one form to capture each 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 at preceding bulleted item must include at least the following data:
DIAGNOSTIC STATUS AT 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 details.
4.1.1 PERINATAL HIV EXPOSURE
• Select “Perinatal HIV Exposure” if the patient is aged less than 18 months, 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 elaboration.
4.1.2 PEDIATRIC HIV
• Select “PEDIATRIC HIV” if the patient meets criteria specified in the Revised Surveillance
7
•
Case Definition for HIV Infection and does not meet the current CDC pediatric AIDS case
definition.
Refer to Appendix 4.1.2 for elaboration.
4.1.3 PEDIATRIC AIDS
• Select “Pediatric AIDS” if patient meets the current AIDS case definition for children < 13
years of age.
• Refer to Appendix 4.1.3 for elaboration.
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.
• With respect to 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 Dept & Health Care Providers)
• Select patient’s sex assigned at birth.
• Refer to Appendix 4.2 for further details.
4.3
COUNTRY OF BIRTH (Optional, applies to Health Dept & Health Care Providers)
• Select applicable response from boxes provided.
• Refer to Appendix 4.3 for legal values when dependency or country is to be specified.
4.4 DATE OF BIRTH (Required, applies to Health Dept & Health Care Providers)
• Enter patient’s month, day, and year of birth.
• Enter date in mmddyyyy format.
4.5
ALIAS DATE OF BIRTH (Optional, applies to Health Dept & Health Care Providers)
• If available, write in the Alias date of birth.
• Enter date in mmddyyyy format.
4.6 VITAL STATUS (Required, applies to Health Dept & Health Care Providers)
• Select applicable response.
• For further guidance on death ascertainment, see CDC’s Technical Guidance for HIV Surveillance
Programs, Volume I: Policies and Procedures, Death Ascertainment.
4.7 DATE OF DEATH (Required if applicable, applies to Health Dept & Health Care Providers)
• If patient is deceased, enter date of death.
• Enter date in mmddyyyy format.
• For further guidance on death ascertainment, see CDC’s Technical Guidance for HIV Surveillance
Programs, Volume I: Policies and Procedures, Death Ascertainment.
4.8
STATE OF DEATH (Optional if applicable, applies to Health Dept & Health Care Providers)
• If patient is deceased, enter the state/territory where death occurred.
4.9
DATE OF LAST MEDICAL EVALUATION (Optional, applies to Health Dept & Health Care
Providers)
• Enter the month, day and year of the child’s last medical evaluation, regardless of reason for exam.
This includes emergency room visits.
• Enter date in mmddyyyy format.
4.10 DATE OF INITIAL EVALUATION FOR HIV INFECTION (Optional, applies to Health Dept &
Health Care Providers)
8
•
•
•
•
Enter the date of initial evaluation for HIV infection. 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.
Enter date in mmddyyyy format.
Refer to Appendix 4.10 for further details.
4.11 ETHNICITY (Required, applies to Health Dept & Health Care Providers)
• Select applicable response.
• If no ethnicity information is available, select “Unknown”.
• Do not choose unknown unless search for this datum was unsuccessful.
• Refer to Appendix 4.11 for further details.
4.12 EXPANDED ETHNICITY (Optional if applicable, applies to Health Dept & 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 Dept & 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”.
• Refer to Appendix 4.13 for further details.
4.14 EXPANDED RACE (Optional if applicable, applies to Health Dept & 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 Africa.Egyptian”.
Refer to the eHARS Technical Reference Guide for listing of expanded race.
5 Residence at Diagnosis
5.1
ADDRESS TYPE (Required, applies to Health Dept & Health Care Providers)
• Select one of the address types (residence at HIV diagnosis, residence at AIDS diagnosis,
residence at perinatal exposure, residence at pediatric seroreverter, check if same as current
address) for the patient’s residence at diagnosis being reported on the case report form
5.2
STREET ADDRESS (Required, applies to Health Dept & Health Care Providers)
• Enter residence’s street address at diagnosis or HIV status
5.3 CITY (Required, applies to Health Dept & Health Care Providers)
• Enter city of patient’s residence at diagnosis or HIV status.
5.4 COUNTY (Required, applies to Health Dept & Health Care Providers)
9
• Enter county of patient’s residence at diagnosis or HIV status.
5.5 STATE/COUNTRY (Required, applies to Health Dept & Health Care Providers)
• Enter the state/country of patient’s residence at diagnosis or HIV status.
5.6 ZIP CODE (Required, applies to Health Dept & Health Care Providers)
• Enter the ZIP code of patient’s residence at diagnosis or HIV status.
6 State/Local Use Only
Diagnosing physician or healthcare provider identifier information is supplied in this section.
6.1
PHYSICIAN’S NAME (Optional)
• Enter name of physician who diagnosed patient (last, first, M.I.).
• Enter name of physician medically managing patient.
• Refer to Appendix 6.1 for further guidance.
6.2
PHONE NO. (Optional)
• Enter phone number of physician named at 6.1, above.
• If no physician is named, enter phone number of the facility of diagnosis.
6.3
MEDICAL RECORD NO.
• Enter medical record number of the patient if available that is being used by the
physician or healthcare provider who diagnosed the patient (if different).
• Refer to Appendix 1.10 for further guidance.
6.4
HOSPITAL/FACILITY (Optional)
• Enter the name of the facility where the report originated.
• If this report is generated from a laboratory report of HIV infection, the laboratory
slip should contain the name of the facility where the specimen was collected.
6.5
PERSON COMPLETING FORM (Optional, applies to Health Dept & Health Care Providers)
• Enter the name of the person completing the form who can be contacted to clarify
entries and supply additional information.
10
7 Facility of Diagnosis
7.1
DIAGNOSIS TYPE
• Enter the diagnosis type that the patient first received (HIV, AIDS, perinatal exposure, check
if same as facility providing information).
7.2
FACILITY NAME (Optional, applies to Health Dept & Health Care Providers)
• Enter name of the facility where patient was first diagnosed with diagnosis or
exposure type being reported.
• If HIV, stage 1-2, unknown and stage 3 (AIDS) diagnoses occurred at
different facilities, enter name of each on separate forms, specifying which
diagnosis occurred at which facility.
• Refer to Appendix 7.2 for further details.
7.3
PHONE (Optional, applies to Health Dept & Health Care Providers)
• Enter facility’s current area code and telephone number.
7.4
STREET ADDRESS (Optional, applies to Health Dept & Health Care Providers)
• Enter facility’s street address.
7.5
CITY (Optional, applies to Health Dept & Health Care Providers)
• Enter city where facility of diagnosis is located.
7.6
COUNTY (Optional, applies to Health Dept & Health Care Providers)
• Enter county where facility of diagnosis is located.
7.7
STATE/COUNTRY (Optional, applies to Health Dept & Health Care Providers)
• Enter state, country name where facility of diagnosis is located.
7.8
ZIP CODE (Optional, applies to Health Dept & Health Care Providers)
• Enter ZIP code where facility of diagnosis is located.
7.9 FACILITY TYPE (Required, applies to Health Dept & Health Care Providers)
• Select applicable response corresponding to the type of facility where patient
received diagnosis of HIV.
• Refer to Appendix 7.9 for further details.
7.10 PROVIDER NAME (Optional)
• Enter provider’s name where patient first received a diagnosis of HIV, stage
1-2 or stage 3 (AIDS).
7.11 PROVIDER PHONE (Optional)
• Enter provider’s current area code and telephone number.
7.12 SPECIALTY
11
•
Enter provider’s specialty.
8 Patient History
Maternal perinatal exposure is the predominant risk factor for pediatric HIV cases.
• Respond to each risk factor, selecting “Yes” for all factors that apply, “No” for those that do not
apply, and “Unknown” for those for which investigation failed to yield an answer. See Appendix
Section V for more general guidance or further information about how to ascertain risk factor
information.
• Collect data about the risk factors that occurred before the first positive HIV test or AIDS
diagnosis. See Technical Guidance for HIV Surveillance Programs, Volume 1: Policies
and Procedures, Risk Factor Ascertainment, Risk Factor Ascertainment Procedures,
Epidemiologic Follow-Up. Risk factor information on the mother refers to behaviors that started
before the child’s birth.
• Information on the child refers to circumstances or behaviors that were thought to have exposed
the child 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
12
suspected. For further information on Cases of Public Health Importance, refer to this passwordprotected site: http://www2a.cdc.gov/hicsb/docs/COPHI_Protocol.pdf. Consult your local HIV
Surveillance Coordinator for access. COPHI is also covered in Technical Guidance for HIV
Surveillance Programs, Volume I: Policies and Procedures, Risk Factor Ascertainment, Cases
of Public Health Importance.
8.1
CHILD’S BIOLOGICAL MOTHER’S HIV INFECTION STATUS (Required, applies to
Health Dept & Health Care Providers)
• Select applicable response.
• Refer to Appendix 8.1 for further details.
• If mother was diagnosed with HIV infection, select from boxes 3–8, depending on
information available to determine the timing of her diagnosis. Where date of mother’s first
positive HIV confirmatory test is available, establish which box to select by comparing to
the date of birth and then selecting the appropriate box.
• Refer to Appendix 8.1 for further details.
8.2
DATE OF MOTHER’S FIRST POSITIVE HIV CONFIRMATORY TEST (Optional, applies
to Health Dept & Health Care Providers)
• Where mother is known to be HIV infected, enter month, day, and year of the first positive
HIV confirmatory test.
• If year is present and search for month was unsuccessful, then enter “..” for the unknown
month followed by the documented year.
• Refer to Appendix 8.3 for further details.
8.3
WAS THE BIOLOGICAL MOTHER COUNSELED ABOUT HIV TESTING DURING THIS
PREGNANCY, LABOR, OR DELIVERY? (Optional, applies to Health Dept & Health Care
Providers)
• Select applicable response.
• Select “Yes” if mother was counseled at anytime 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.
• Refer to Appendix 8.3 for further details.
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 Dept &
Health Care Providers)
• Select applicable response.
8.4.2 INJECTED NON-PRESCRIPTION DRUGS (Required, applies to Health Dept & Health
Care Providers)
• Select applicable response.
8.4.3 BIOLOGICAL MOTHER HAD HETEROSEXUAL RELATIONS WITH ANY OF THE
FOLLOWING:
• This section, addressed at 8.5.3–8.5.3.6, 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.
8.4.3.1 INTRAVENOUS/INJECTION DRUG USER (Required, applies to Health
Dept & Health Care Providers)
• Select applicable response.
13
8.4.3.2
8.4.3.3
8.4.3.4
8.4.3.5
8.4.3.6
BISEXUAL MALE (Required, applies to Health Dept & Health
Care Providers)
• Applies only to female case patients.
• Select applicable response.
PERSON WITH HEMOPHILIA/COAGULATION DISORDER WITH
DOCUMENTED HIV INFECTION (Required, applies to Health Dept &
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 8.4.3.3 for further details.
• Alert state/local COPHI coordinator.
TRANSFUSION RECIPIENT WITH DOCUMENTED HIV INFECTION
(Required, applies to Health Dept & Health Care Providers)
• Select applicable response.
• Consider documenting the reason for transfusion in the comments section.
• Refer to Appendix 8.4.3.4 for further details.
• Alert state/local COPHI coordinator.
TRANSPLANT RECIPIENT WITH DOCUMENTED HIV INFECTION
(Required, applies to Health Dept & Health Care Providers)
• Select applicable response.
• Consider recording documentation available about the transplant in the
comments section.
• Alert state/local COPHI coordinator.
PERSON WITH AIDS OR DOCUMENTED HIV INFECTION, RISK NOT
SPECIFIED (Required, applies to Health Dept & Health Care Providers)
• Select “Yes” only if male partner is known to be HIV
positive and that partner’s risk for HIV is unknown.
8.4.4 RECEIVED TRANSFUSION OF BLOOD/BLOOD COMPONENTS (each element
Required, applies to Health Dept & Health Care Providers)
• Select applicable response.
• 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 or AIDS.
• If the last transfusion was after March 1985, then alert state/local COPHI coordinator.
8.4.5 RECEIVED TRANSPLANT OF TISSUES/ORGANS OR ARTIFICIAL
INSEMINATION (each element Required, applies to Health Dept & Health Care
Providers)
• Select applicable response.
• 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; then alert state/local 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.”
14
8.5
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.
8.5.1 INJECTED NON-PRESCRIPTION DRUGS (Required, applies to Health Dept & Health
Care Providers)
• Select applicable response.
8.5.2 RECEIVED CLOTTING FACTOR FOR HEMOPHILIA/COAGULATION DISORDER
(Required, applies to Health Dept & 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).
• Select applicable response.
• If “Yes” specify.
• Alert state/local COPHI coordinator if child was born after March 1998 and receipt of
clotting factor is the suspected mode of HIV transmission.
• Refer to Appendix 8.5.2 for further details.
8.6.1.1 SPECIFY CLOTTING FACTOR (Required, applies to Health Dept & Health
Care Providers)
• If “Yes” to 8.6.1, above, then enter the specific clotting factor.
8.5.3 RECEIVED TRANSFUSION OF BLOOD/BLOOD COMPONENTS (OTHER THAN
CLOTTING FACTOR) (Required, applies to Health Dept & 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 AIDS.
• It is often helpful to document the reason for the transfusion in the Comments section.
8.5.4 RECEIVED TRANSPLANT OF TISSUE/ORGANS (Required, applies to Health Dept
& Health Care Providers)
• The case will be initially classified as “risk not reported/identified”pending outcome
of the no identified risk (NIR) investigation.
• Alert the state/local COPHI coordinator.
8.5.5 SEXUAL CONTACT WITH A MALE (Required, applies to Health Dept & 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.
8.5.6 SEXUAL CONTACT WITH A FEMALE (Required, applies to Health Dept & 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.
8.5.7 OTHER DOCUMENTED RISK (Alert State/Local NIR Coordinator) (Required, applies
to Health Dept & Health Care Providers)
15
•
Select this response only if directed to do so by the state/local NIR coordinator.
9 Laboratory Data
9.1
•
•
“COLLECTION DATE” refers to the date when the specimen was collected or drawn.
Enter dates in mmddyyyy format.
•
If search for either or both of these data was unsuccessful, then enter “..” for unknown day,
month or year of “COLLECTION DATE.”
•
Record all laboratory tests.
•
Include all diagnostic, viral detection, 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, stage 1-2 or stage 3 (AIDS) diagnostic evidence
documented in the chart by a physician.
•
If the following brief instructions for recording HIV-related tests are insufficient, see
the Technical Guidance for HIV Surveillance Programs, Volume I: Policies and Procedures,
Electronic Reporting, HIV and HIV-associated Laboratory Tests.
HIV ANTIBODY TESTS (NON_TYPE 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
16
results.
•
Enter results and collection dates for first positive HIV antibody tests.
•
The possible results are: Positive/Reactive, Negative/Nonreactive, or Indeterminate
•
Check the Rapid Test box if the test is rapid.
•
Enter date in mmddyyyy format.
Enter the name of assay manufacturer
9.1.1 HIV-1 EIA (each element Required, applies to Health Dept & Health Care Providers)
• Enter result and collection date of first HIV-1 EIA.
• “Positive EIA” means repeatedly reactive tests on a single sample.
• Enter date in mmddyyyy format.
9.1.2 HIV-1/2 COMBINATION EIA (each element Required, applies to Health Dept &
Health Care Providers)
• Enter result and collection date of first HIV-1/ 2 combination EIA test.
• If tests indicate HIV-1 or HIV-2 results separately, please specify the results as given
in the laboratory report.
• Enter date in mmddyyyy format.
9.1.3 HIV-1/2AgAb
• Enter results and collection date of combined p24 antigen and anti HIV1/2 antibody
screening assay.
• Enter date in mmddyyyy format.
9.1.4 HIV-1 WESTERN BLOT (each element Required, applies to Health Dept & Health Care
Providers)
• Enter the result and collection date of first HIV-1 Western blot.
• Enter date in mmddyyyy format.
9.1.5 HIV-1 IFA (each element Required, applies to Health Dept & Health Care Providers)
• Enter the result and collection date of first HIV-1 IFA.
• Enter date in mmddyyyy format.
9.1.6 HIV-2 EIA (each element Required, applies to Health Dept & Health Care Providers)
• Enter result and date of first HIV-2 EIA.
• “Positive EIA” means repeatedly reactive tests on a single sample.
• Enter date in mmddyyyy format.
9.1.7 HIV-2 WESTERN BLOT (each element Required, applies to Health Dept & Health Care
Providers)
• Enter the result and collection date of first HIV-2 Western blot. Enter date in
mmddyyyy format.
• If HIV-1 tests other than those at 9.1.1–9.1.5 were employed, specify the type of test
performed.
• Enter the result and collection date.
• Enter date in mmddyyyy format.
17
9.2 HIV ANTIBODY TESTS (TYPE DIFFERENTIATING)
•
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 first positive HIV antibody tests. The possible results
are: HIV-1, HIV-2, Both (undifferentiated), or Neither (negative).
•
Enter date in mmddyyyy format.
9.3
HIV DETECTION TESTS (QUALITATIVE) (Required, applies to Health Dept &
Health Care Providers)
•
These are all qualitative tests. All varieties of such tests establish the presence of the
pathogen, HIV. By contrast, HIV tests such as the EIA or Western blot establish the
presence of our immune systems’ response to the pathogen—HIV antibodies.
•
Select applicable response corresponding to earliest positive detection test.
•
The possible results are: Positive/Reactive, Negative/Nonreactive, or Indeterminate.
9.3.1 HIV-1 RNA/DNA NAAT (QUAL)
9.3.2 HIV-1 P24 ANTIGEN (Required, applies to Health Dept & Health Care Providers)
• Antigens are the virus’s own proteins; such tests are specific for these proteins.
• Enter result and collection date of earliest antigen test.
• Enter date in mmddyyyy format.
9.3.3 HIV-1 CULTURE (Required, applies to Health Dept & Health Care Providers)
• Enter result and collection date of earliest test by culture.
• Enter date in mmddyyyy format.
9.3.4 HIV-2 RNA/DNA NAAT (QUAL)
9.3.5 HIV-2 CULTURE (Required, applies to Health Dept & Health Care Providers)
• Enter result and collection date of earliest test by culture.
• Enter date in mmddyyyy format.
9.4
HIV DETECTION TESTS (QUANTITATIVE VIRAL LOAD)
•
9.4.1
HIV-1 RNA/DNA NAAT (QUANTITATIVE VL)
o The possible results are: Detectable or Undetectable
o Enter results in units of copies per milliliter (mL) and Log. Enter the month, day,
and year test was collected. Viral load tests with undetectable results should also
be entered here.
o COPIES/ML (each element Required, applies to Health Dept & Health Care
Providers) Enter result in units of viral copies per milliliter. 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
9.5
IMMUNOLOGIC TESTS (CD4 COUNT AND PERCENTAGE)
18
•
Whenever CD4 count and percentage are both available, record both. Enter specimen
collection date to the reported CD4 test result
9.5.1 CD4 AT OR CLOSEST TO CURRENT DIAGNOSTIC STATUS
9.5.1.1 CD4 COUNT (Required, applies to Health Dept & Health Care Providers)
• For HIV reports, record the CD4 count closest to the time 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. For HIV, stage 3
(AIDS) reports, record the CD4 count with date at or closest to the date of
AIDS diagnosis. This AIDS diagnosis date is typically the date on which an
AIDS-defining illness is diagnosed or the specimen collection date of a CD4
count < 200 cells/μL.
9.5.1.2 CD4 PERCENTAGE (Required, applies to Health Dept & Health Care
Providers)
• For HIV reports, record the CD4 percentage with date at or closest to the
date of HIV diagnosis. For stage 3 (AIDS) reports, record the CD4
percentage at or closest to the time that an AIDS-defining clinical condition
was first diagnosed. This AIDS diagnosis date is typically the date on which
an AIDS-defining illness is diagnosed or the specimen collection date of a
CD4 percent <14%.
9.5.2 FIRST CD4 RESULT < 200 cells/μL or < 14%
9.5.2.1 CD4 COUNT (Required if available, applies to Health Dept & Health Care
Providers)
• Enter results and specimen collection date of first CD4 < 200 cells/μL.
• Enter date in mmddyyyy format.
9.5.2.2 CD4 PERCENTAGE (Required if available, applies to Health Dept & Health
Care Providers)
• Record results and specimen collection date of first CD4 <14%.
• Enter date in mmddyyyy format.
9.5.3 Other CD4 RESULT
9.5.3.1 CD4 COUNT (Required if available, applies to Health Dept & Health Care
Providers)
• Enter results and specimen collection date of other CD4 count.
• Enter date in mmddyyyy format.
9.5.3.2 CD4 PERCENTAGE (Required if available, applies to Health Dept & Health
Care Providers)
• Record results and specimen collection date of other CD4 percentage.
• Enter date in mmddyyyy format.
9.6
DOCUMENTATION OF TESTS
9.6.1 DATE OF EARLIEST POSITIVE TEST FOR MEETING THE HIV DIAGNOSTIC
ALGORITHM CRITERIA
• This section captures diagnoses through novel algorithms, and should only be
completed if none of the following were positive: HIV-1 Western blot; p24 Ag test; or
qualitative NAAT (RNA or DNA) or a detectable viral load
19
•
•
•
Select applicable response.
If “Yes”, enter date of earliest positive test for this algorithm in mmddyyyy format.
Not to be used for <18 months of age
9.7 IF LABORATORY TESTS WERE NOT DOCUMENTED, IS HIV DIAGNOSIS CONFIRMED
BY A PHYSICIAN? (Required if applicable, applies to Health Dept & Health Care Providers)
• Select applicable response. 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.”
9.7.1 IF “YES” (TO 9.6) PROVIDE DATE OF DOCUMENTATION BY PHYSICIAN
(Required in the absence of lab results, applies to Health Dept & Health Care Providers)
• If antibody tests are not available in chart, enter date that physician diagnosed or first
knew about patient’s HIV infection. Record the date on which physician accepts and
notes patient’s diagnosis of HIV infection. Do not record earlier date stated by the
patient.
10 Clinical
10.1 CLINICAL
10.1.1–10.1.24 (Optional, applies to Health Dept & Health Care Providers)
• Select all that apply and enter diagnosis dates (mmddyyyy).
• Enter “..” for unknown month.
• Refer to Appendix 10.1 for further details.
10.2 HAS THIS CHILD BEEN DIAGNOSED WITH PULMONARY TUBERCULOSIS?
• Select applicable response.
• If “Yes,” provide the month, day and year of diagnosis.
10.2.1 IF “YES,” INITIAL DIAGNOSIS AND
20
•
•
10.2.2
10
Select applicable response and enter month, day and year of diagnosis.
If search for this datum was unsuccessful, enter “..” for month of initial diagnosis
followed by the documented year.
RVCT CASE NUMBER.
• 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
AIDS patients may get this number from TB surveillance staff.
Birth History
11.1
BIRTH HISTORY AVAILABLE (Optional, applies to Health Dept & Health Care Providers)
• Select applicable response.
• If birth history is not available, proceed to next section.
11.2
RESIDENCE AT BIRTH (Optional, applies to Health Dept & Health Care Providers)
• Select check if same as current address if applicable.
• Use mother’s residence at time of infant’s birth.
• Enter street address, city, county, state/country, and zip code of the residence at birth.
11.3
HOSPITAL OF BIRTH (Optional, applies to Health Dept & Health Care
Providers)
• Select check if same as facility processing information if applicable.
• Enter name, address, phone, city, county, state/country and zip code of the hospital/clinic
21
•
•
11.4
11.5
of birth.
Sites should uniformly record hospital names, including abbreviations.
If this child was born at home, enter “home birth.”
BIRTH HISTORY
11.4.1
BIRTH WEIGHT (Optional, applies to Health Dept & Health Care Providers)
• Enter the birth weight in pounds or grams as requested on the form.
• If recorded in pounds and ounces, convert to grams.
11.4.2
TYPE (Optional, applies to Health Dept & Health Care Providers)
• Select applicable response. If unknown, select “9.”
11.4.3
DELIVERY (Optional, applies to Health Dept & Health Care Providers)
• Select applicable response. If unknown, select “9.”
• Notes in the child’s records are acceptable even if no birth records are available.
• Refer to Appendix 11.4.3 for further details.
11.4.4
BIRTH DEFECTS (Optional, applies to Health Dept & Health Care Providers)
• Select applicable response.
• If “Yes,” specify type.
• Refer to Appendix 11.4.4 for further details and an abbreviated list of birth defects
NEONATAL STATUS (Optional, applies to Health Dept & 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 “..” 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 Dept & 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 Dept & 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.”
• Refer to Appendix 11.6.1 for further details.
• If search for this datum was unsuccessful, then enter “..” for month of first visit.
11.6.2
TOTAL NUMBER OF PRENATAL CARE VISITS (Optional, applies to Health
22
Dept & Health Care Providers)
• Record the total number of times the mother went to the clinic or doctor for her
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 “..” 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?
(Optional, applies to Health Dept & 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
DID MOTHER RECEIVE ARVs DURING PREGNANCY? (Optional, applies to Health
Dept & Health Care Providers)
• If a woman did not receive ARVs, do not assume it was because she refused it.
• Select “Refused” only if specific documentation in the record clearly states that she was
offered the drug but she declined.
• In the absence of evidence of the patient having taken the drug, select “No.”
• “Unknown” should be used only if the pregnancy records are not available.
11.8.1
11.9
IF “YES,” PLEASE SPECIFY ALL
IF “YES,” PLEASE SPECIFY ALL
DID MOTHER RECEIVE ARVs DURING LABOR/DELIVERY? (Optional, applies to
Health Dept & Health Care Providers)
• Select “Yes” if information is available that states that the mother used ARVs anytime
before this pregnancy.
• Select “No” if mother never used this antiretroviral.
• Select “Unknown” if it is unknown whether the mother ever used ARVs during
labor/delivery.
11.9.1
IF “YES,” PLEASE SPECIFY ALL
• For a list of antiretroviral therapies currently available and link to treatment guidelines,
refer to Appendix 11.10.
11.10 MATERNAL INFORMATION
11.10.1 MATERNAL DATE OF BIRTH (DOB) (Optional, applies to Health Dept)
• Enter the biological mother’s month, day, and year of birth.
23
11.10.2 MATERNAL SOUNDEX (Optional, applies to Health Dept)
• Enter maternal soundex here.
• Refer to Appendix 11.10.2 for further details.
11.10.3 MATERNAL STATENO. (Optional, applies to Health Dept)
• 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 Dept)
• Mark the box corresponding to the biological mother’s country of birth.
• If this information is not available in the child’s records, it can be left blank and
updated on follow-up.
• Refer to Appendix 11.10.4 for further details.
11.10.5 OTHER MATERNAL ID-LIST TYPE
• Enter any other maternal’s ID type (such as social security number) and the
number of the other ID.
11
Services 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
THIS CHILD RECEIVED OR IS RECEIVING
12.1.1
NEONATAL ANTIRETROVIRALS FOR HIV PREVENTION (Optional, applies
to Health Dept & Health Care Providers)
• Record whether child received any neonatal (first 6 weeks of life)
ARVs to prevent perinatal HIV infection.
• Refer to Appendix 12.1.1 for further details.
• If “Yes,” record the day, month, and year the child was started on other
antiretrovirals as prophylaxis during the first 6 weeks of life.
• If the year and month are present but search for day was unsuccessful, then enter
“..” for the day followed by the documented year and month.
12.1.1.1 IF “YES,” PLEASE SPECIFY (Optional, applies to Health Dept & Health
Care Providers)
24
• If “Yes,” write in the type of medication received.
• Refer to Appendix 12.1.1.1 for examples.
12.1.2
ANTI-RETROVIRAL THERAPY FOR HIV TREATMENT (Optional, applies to
Health Dept & Health Care Providers)
• Select applicable response.
• If “Yes,” record month, day and year the child started on any antiretroviral therapy
for treatment of confirmed HIV infection.
• Refer to Appendix 12.1.3 for further details.
12.1.3
PCP PROPHYLAXIS (Optional, applies to Health Dept & Health Care Providers)
• Select applicable response.
• If “Yes,” enter the month, day, and year the child was started on therapy to
prevent the occurrence of PCP.
• If the year and month are present without a designated day, “..” should be entered
for the day followed by the documented year and month.
• Refer to Appendix 12.1.3 for further details.
• 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.”
• “Unknown” is used if treatment information in the medical chart is unclear or was
unavailable.
12.2
WAS THIS CHILD BREASTFED? (Optional, applies to Health Dept & Health Care
Providers)
• Select applicable response.
• Refer to Appendix 12.2 for further details.
• If there is suspicion that the child’s only exposure to HIV was through breast milk, the
local/state NIR coordinator should be alerted.
12.3
THIS CHILD’S PRIMARY CARETAKER IS (Optional, applies to Health Dept & Health
Care Providers)
• Select the response corresponding to the persons who give the majority of care for the
child.
• For children living with two biological parents or just one, “Biological parent(s)” should
be selected.
• Refer to Appendix 12.3 for further details.
25
12
Comments and Local/Optional Fields
13.1
COMMENTS (Optional)
This section can be used for information not requested on the form. For example, surveillance
staff may document investigative progress toward ascertainment of risk factor information.
• If city or facility of treatment in another state is known, record these data on as many case
report forms (CRFs) as there are facilities. Each facility represents a separate information
source.
13.2
LOCAL /OPTIONAL FIELDS
• 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.
26
Appendix:
Pediatric HIV Confidential Case Report
(CDC 50.42B)
Instructions for Completion
Purpose
•
Information captured on the form 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 their prevention activities.
•
CDC’s Division of HIV/AIDS Prevention (DHAP) needs reports and updates to reflect the earliest
dates that children meet each reporting criteria (i.e., perinatal exposure, HIV infection, AIDS,
seroreverter), as well as changes in diagnostic or vital status.
• When a child who was previously reported as HIV infected has progressed to
AIDS or has died, state/reporting area personnel update the database 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 update 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 form can accommodate updated information including immunologic markers and diagnoses
of opportunistic infections.
•
CDC updated the HIV reporting form 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 or to 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
2000 HIV case definition in the CDC Guidelines for National Human Immunodeficiency
Virus Case Surveillance, Including Monitoring for Human Immunodeficiency Virus Infection
27
and Acquired Immunodeficiency Syndrome (MMWR 1999;48(RR-13):1–31), available
at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr4813a1.htm, and the 2008 case definition
(MMWR 2008; 57 (RR-10) 1-12
at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5710a1.htm?s_cid=rr5710a1_e
Pediatric Cases of Public Health Importance (COPHI)
•
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
unusual transmission circumstances. This direct communication will ensure the timeliest technical
support. COPHI is covered in Technical Guidance for HIV/AIDS Surveillance Programs, Volume
I: Policies and Procedures, Risk Factor Ascertainment, Cases of Public Health Importance
(COPHI).
1.0 PATIENT IDENTIFICATION
1.11
MEDICAL RECORD NUMBER
• 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 or AIDS documentation. Additional numbers can be noted in the
Comments section, clearly annotating which facility is associated with which record
number.
2.0 HEALTH DEPARTMENT USE ONLY
2.6
DOCUMENT SOURCE
• If “Other database,” “Other Clinic,” “Other,” or “Out of state” is selected, specify source
in Section X, Comments.
• Two-level codes for report source are shown below. The first level of source code is
required, and the second level is recommended.
Document Source Codes for HIV Reporting
First level source Second (more detailed) level source
28
First level source Second (more detailed) level source
A01. = Inpatient
A01.01 = IP/Acute care facility
A01.01.02 = IP/ACF/OBGYN records
A01.01.03 = IP/ACF/Pediatric records
A01.01.04 = IP/ACF/Birth records
A01.02 = IP/VA
A01.03 = IP/Military hospital
A01.03.02 = IP/Military/OBGYN records
A01.03.03 = IP/Military/Pediatric records
A01.04 = IP/Long-term care facility
A01.04.03 = IP/LTCF/Drug TX program
A01.05 = IP/Hospice
A02. = Outpatient
A02.01 = OP/HMO
A02.02 = OP/VA
A02.03 = OP/Private physician
A02.04 = OP/Adult HIV Clinic
A02.05 = OP/Infect. Dis. Clinic
A02.06 = OP/County HD clinic
A02.07 = OP/Maternal HIV clinic
A02.08 = OP/Prenatal clinic or records
A02.09 = OP/Pediatric HIV clinic
A02.10 = OP/OBGYN clinic (not HIV related)
A02.11 = OP/Pediatric clinic
A02.12 = OP/TB clinic
A02.14 = OP/IHS clinic
A02.15 = OP/Early intervention nurse
A02.16 = OP/Visiting nurse service
A02.17 = OP/Hemophilia TX clinic
A02.18 = OP/Hospice
A02.19 = OP/Drug TX center
A02.20 = OP/Rehab center
A02.25 = OP/Other clinic
A03. = Emergency room
A03 = Emergency room
29
First level source Second (more detailed) level source
A04. = Screening, diagnosis,
and referral agencies
A04.01 = Scr, Dx, Ref/Blood bank
A04.02 = Scr, Dx, Ref/Drug TX program
A04.03 = Scr, Dx, Ref/Family planning clinic
A04.04 = Scr, Dx, Ref/HIV case management agency
A04.05 = Scr, Dx, Ref/HIV counseling & testing site
A04.06 = Scr, Dx, Ref/Immigration report
A04.07 = Scr, Dx, Ref/Insurance report
A04.08 = Scr, Dx, Ref/Job Corps
A04.09 = Scr, Dx, Ref/Military
A04.10 = Scr, Dx, Ref/Partner referral & counseling service
A04.11 = Scr, Dx, Ref/STD clinic
A05. = Laboratory
A05.01 = Lab/hosp.
A05.02 = Lab/state
A05.03 = Lab/private
30
First level source Second (more detailed) level source
A06. = Other databases
A06.01 = Other DB/ADAP
A06.02 = Other DB/ASD
A06.03 = Other DB/Birth certificate
A06.04 = Other DB/Birth defects registry
A06.05 = Other DB/Cancer registry
A06.06 = Other DB/Database from coroner
A06.07 = Other DB/Death certificate review
A06.08 = Other DB/EHRAP database
A06.09 = Other DB/EPS database
A06.10 = Other DB/HARS database
A06.11 = Other DB/Health department records
A06.12 = Other DB/Hepatitis registry
A06.13 = Other DB/Hosp billing summary or discharge data
A06.14 = Other DB/HRSA HIV Care database
A06.15 = Other DB/Immunization registry
A06.16 = Other DB/Medicaid records
A06.17 = Other DB/NDI
A06.18 = Other DB/Out-of-state report
A06.19 = Other DB/Prison, jail, or other correctional facility database
A06.20 = Other DB/PSD
A06.21 = Other DB/State disease registry
A06.22 = Other DB/SHAS
A06.23 = Other DB/SHDC database
A06.24 = Other DB/STD registry
A06.25 = Other DB/TB registry
A06.50 = Other DB/Other database or report
A07. = Other facility records
A07.01 = Oth facility records/Prison, jail, or other correctional facility
A07.02 = Oth facility records/Coroner, not associated with IP facility
A10 = Other source
A10 = Other source
(specify)
Unknown
31
4.0 PATIENT DEMOGRAPHICS
4.1
DIAGNOSTIC STATUS AT REPORT
• See 4.1.1–4.1.4, below.
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
CONFIRMED HIV INFECTION (NOT AIDS)
• Among children aged greater than or equal to 18 months and less than 13 years, a
reportable case of HIV infection must meet at least one of the following criteria:
Laboratory Criteria
• Positive result on a screening test for HIV antibody (e.g., repeatedly reactive enzyme
immunoassay), followed by a positive result on a confirmatory (sensitive and more specific)
test for HIV antibody (e.g., Western blot or immunofluorescence antibody test) OR
• Positive result or report of a detectable quantity on any of the following HIV virologic
(nonantibody) tests:
HIV nucleic acid (DNA or RNA) detection (e.g., DNA polymerase chain reaction [PCR]
or plasma HIV-1 RNA)
HIV p24 antigen test, including neutralization assay
HIV isolation (viral culture)
OR
Clinical or Other Criteria (if the above laboratory criteria are not met)
• Diagnosis of HIV infection, based on the laboratory criteria above, that is documented in a
medical record by a physician OR
• Conditions that meet criteria included in the case definition for AIDS
32
• Among children aged less than 18 months, a reportable case of HIV infection must
meet at least one of the following criteria:
Laboratory Criteria
Definitive
• Positive results on two separate specimens (excluding cord blood) using one or more of the
following HIV virologic (nonantibody) tests:
HIV nucleic acid (DNA or RNA) detection
HIV p24 antigen test, including neutralization assay, in a child greater than or equal to 1
month of age
HIV isolation (viral culture)
OR
Presumptive
• A child who does not meet the criteria for definitive HIV infection but who has:
Positive results on only one specimen (excluding cord blood) using the above HIV
virologic tests and no subsequent negative HIV virologic or negative HIV antibody test
OR
Clinical or Other Criteria (if the above definitive or presumptive laboratory criteria are not met)
• Diagnosis of HIV infection, based on the laboratory criteria above, that is documented in a
medical record by a physician OR
• Conditions that meet criteria included in the 1987 pediatric surveillance case definition for
AIDS (http://www.cdc.gov/mmwr/pdf/other/mmsu3601.pdf)— see next page for detailed
listing.
• In the absence of laboratory evidence of HIV infection in the child, that child
meets the HIV case definition if diagnosed with conditions that meet the criteria in
the 1987 pediatric case definition for AIDS if born to a mother known to be
infected at the time of birth.
• The current HIV case definition for children less than 13 years of age, and persons
of all ages, is available
at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr4813a2.htm.
33
4.1.3
AIDS
• The current pediatric AIDS case definition is available
at http://www.cdc.gov/mmwr/pdf/other/mmsu3601.pdf. The current HIV case
definition is located at :
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5710a1.htm?s_cid=rr5710a1_e
The 1994 revised classification system for HIV infection in children less than 13
years of age is available
at http://www.cdc.gov/mmwr/preview/mmwrhtml/00032890.htm.
• Children who are HIV infected and exhibit any of the following AIDS-defining
clinical conditions should be reported as presumptive AIDS cases; although most
of these conditions appear among adult AIDS diagnostic criteria, asterisked
conditions apply only to pediatric cases.
• For children with an AIDS-defining condition that requires laboratory evidence of
HIV infection, a single positive HIV-detection test (i.e., HIV culture, HIV PCR, or
HIV p24 antigen) is sufficient for a reportable AIDS diagnosis if the diagnosis is
confirmed by a clinician.
• 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
• Lymphoid interstitial pneumonia*
• 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, other species or unidentified species, disseminated or extrapulmonary
• Pneumocystis pneumonia
• Progressive multifocal leukoencephalopathy
• Salmonella septicemia, recurrent
• Toxoplasmosis of brain
34
• Wasting syndrome due to HIV
4.1.4
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:
Laboratory Criteria
Definitive
• At least two negative HIV antibody tests from separate specimens obtained at >6 months of
age
• At least two negative HIV virologic tests* from separate specimens, both of which were
performed at >1 month of age and one of which was performed at >4 months of age
AND
• No other laboratory or clinical evidence of HIV infection (i.e., has not had any positive
virologic tests, if performed, and has not had an AIDS-defining condition)
OR
Presumptive
• A child who does not meet the above criteria for definitive “not infected” status but who has:
One negative EIA HIV antibody test performed at >6 months of age and NO positive HIV
virologic tests, if performed OR
One negative HIV virologic test* performed at >4 months of age and NO positive HIV
virologic tests, if performed OR
One positive HIV virologic test with at least two subsequent negative virologic tests*, at
least one of which is at >4 months of age; or negative HIV antibody test results, at least one
of which is at >6 months of age
AND
• No other laboratory or clinical evidence of HIV infection (i.e., has not had any positive
virologic tests, if performed, and has not had an AIDS-defining condition).
OR
Clinical or Other Criteria (if the above definitive or presumptive laboratory criteria are not met)
• Determined by a physician to be “not infected,” and a physician has noted the results of the
preceding HIV diagnostic tests in the medical record
AND
• NO other laboratory or clinical evidence of HIV infection (i.e., has not had any positive
virologic tests, if performed, and has not had an AIDS-defining condition)
* HIV nucleic acid (DNA or RNA) detection tests are the virologic methods of choice to exclude
infection in children aged <18 months. Although HIV culture can be used for this purpose, it is more
complex and expensive to perform and is less well standardized than nucleic acid detection tests. The
use of p24 antigen testing to exclude infection in children aged <18 months is not recommended
because of its lack of sensitivity.
35
4.2
SEX ASSIGNED AT BIRTH
• In addition to “Male” or “Female” sex at birth, CDC-supplied software includes a third
choice of “Unk.” Although “CURRENT_SEX” is not a variable appearing on the case
report form, the person completing the form may record current sex in Section XI or in the
form’s margin next to Section III—particularly if current sex differs from sex at birth.
• Selections and legal values for “CURRENT_SEX” from eHARS Lookup Codes are as
follows:
CURRENT_SEX = F = Female Person’s current sex
CURRENT_SEX = I = Intersexed Person’s current sex
CURRENT_SEX = M = Male Person’s current sex
•
Additionally, the current form does not include fields for patient gender, but eHARS
optionally does. A variety of genders may be recorded either in the margin of the case
report form at Section III or in the Comments section. Note that “CURRENT_GENDER”
adds behavioral, biological, and iatrogenic selections to those of “current sex.”
•
Selections and legal values for “CURRENT GENDER” from eHARS Lookup Codes are
as follows:
CURRENT_GENDER = CD = Cross Dresser Person’s current gender
CURRENT_GENDER = DQ = Drag Queen Person’s current gender
CURRENT_GENDER = F = Female Person’s current gender
CURRENT_GENDER = FM = Female to Male Person’s current gender
CURRENT_GENDER = I = Intersexed Person’s current gender
CURRENT_GENDER = M = Male Person’s current gender
CURRENT_GENDER = MF = Male to Female Person’s current gender
CURRENT_GENDER = SM = She Male Person’s current gender
4.3
COUNTRY OF BIRTH
• Select first from boxes provided:
United States
Other/US dependency, specify
• For patients born in US dependencies, specify from the following table:
American Samoa
Guam
Johnston Atoll
Mariana Islands
Marshall Islands
Micronesia
Midway Islands
Navassa Island
US dependencies
Pacific Trust Terr.
Palau
Puerto Rico
Ryukyu Islands
Swan Islands
US Virgin Islands
Wake Island
36
4.5
VITAL STATUS
• For further guidance on death ascertainment, see Technical Guidance for HIV/AIDS
Surveillance Programs, Volume I: Policies and Procedures, Death Ascertainment.
4.10
DATE OF INITIAL EVALUATION FOR HIV INFECTION
• Enter the date of initial evaluation for HIV infection.
• Evidence of HIV infection in a child must be obtained on or after the birth date.
4.11
ETHNICITY
• Regardless of the presence of race or absence of any information, collect data on ethnicity.
• As of January 2003, the US Office of Management and Budget (OMB) required that race
and ethnicity (Hispanic, non-Hispanic) for a person be collected as separate variables.
• A wide variety of ethnicities may be selected from legal values available in CDC-supplied
software. These ethnicities and codes are documented in the eHARS Technical Reference
Guide.
4.13
RACE
• 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 categories:
American Indian or Alaska Native
Asian
Black or African American
Native Hawaiian or Other Pacific Islander
White
• A wide variety of race categories may be selected from legal values available in CDCsupplied software. These races and codes are documented in the eHARS Technical
Reference Guide.
5.0 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 AIDS case reports, enter the patient’s residence at the date of the first AIDS-defining clinical
condition or the date of the first immunologic marker that reaches AIDS-defining thresholds.
RESIDENCE, HOMELESS
• For homeless patients, enter the address that most accurately describes where they stay—
including a shelter address if applicable.
• People without a usual residence should be reported by the jurisdiction where they were
staying at the time of diagnosis.
37
For further guidance about residency assignment, see Technical Guidance for HIV/AIDS Surveillance
Programs, Volume I: Policies and Procedures, Case Residency, Case Residency Assignment.
6.0 STATE/LOCAL USE ONLY
6.1
PHYSICIAN’S NAME
• If the test was provided as part of a visit to a health department, an STD clinic, an HIV
counseling and testing site, or other facility where no single individual is responsible for
medical management of the patient, leave this space blank and complete the “Facility of
Diagnosis” section appropriately.
7.0 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.
• If a facility name is not documented but a physician’s name is listed, enter “Private
Physician” or a numeric code for each physician; enter the name of the physician under
Physician Identifier Information (Section VI).
• For reports of AIDS, enter the name of the facility where the patient’s AIDS- defining
clinical condition was first diagnosed.
• If a physician name is listed without facility name, enter physician name.
• These fields strictly apply to facility where HIV or AIDS was diagnosed. Where chart
abstraction is accomplished at a facility other than the Facility of Diagnosis (Section IV),
document report source; refer to 2.6 for further details.
7.9
FACILITY TYPE
• Select “Physician, HMO” where diagnosis was made at a private, outpatient care site not
associated with a hospital.
• Examples of “Other” include HIV counseling and testing sites, STD clinics, drug treatment
facilities, family planning clinics, prenatal/obstetrics clinics, tuberculosis clinics, and
correctional facilities. Select “Other” for any public outpatient setting.
8.0 PATIENT HISTORY
•
•
•
Surveillance staff have found such information within mother’s chart at discharge summary,
history and physical, social service notes, counseling and testing notes, and STD diagnosis notes.
Where not explicitly annotated, contact child’s provider about maternal/child risk factor
information.
Definition of ‘Risk factors’: The collective term for the individual routes of exposure/transmission
on which data are routinely collected for surveillance of HIV cases. “Yes,” “No,” or “Unknown”
must be selected.
38
•
8.1
See Technical Guidance for HIV/AIDS Surveillance Programs, Volume I: Policies and
Procedures, Risk Factor Ascertainment for further guidance on risk factor data collection. States
should have risk factor ascertainment procedures tailored to their jurisdictions as well.
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, however, mother-to-infant transmission through breast-feeding is considered as the only
mode of transmission, please alert the state or local NIR coordinator and enter in the field
labeled “other” in the patient/maternal history section.
(MOTHER) DIAGNOSED WITH HIV INFECTION/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:
3 - before this child’s pregnancy;
4 - during this child’s pregnancy
5 - at time of delivery (i.e., when admitted for labor/delivery and before discharge from
the birth hospital or within 7 days of birth;
6 - before child’s birth, exact period unknown;
7 - after the child’s birth (i.e., anytime after discharge from birth hospital or after 7 days of
birth); or
8 - HIV-infected, unknown when diagnosed.
• If no information is available regarding maternal HIV status, please select:
9 - HIV status unknown.
8.2
DATE OF MOTHER’S FIRST POSITIVE HIV CONFIRMATORY TEST
The following is adapted from an excerpt of the adult/adolescent HIV surveillance case
definition, accessible at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr4813a2.htm:
Necessary for HIV infection (not AIDS)
• Documentation of +EIA plus +WB/IFA with date
• Detectable viral load with date
• Positive p24 antigen test with date
• Positive viral culture with date
• Physician documentation of HIV with date
8.3
or
or
or
or
MOTHER WAS COUNSELED ABOUT HIV TESTING DURING THIS PREGNANCY,
LABOR, OR DELIVERY?
• Complete this question for all mothers regardless of whether they were diagnosed with
HIV infection before this pregnancy.
• If not, then select “No.”
• If no information in the medical chart is available regarding counseling, then select “Unk.”
8.4.3.3 HETEROSEXUAL RELATIONS WITH PERSON WITH HEMOPHILIA/COAGULATION
DISORDER WITH DOCUMENTED HIV INFECTION
• They do not include other bleeding disorders, such as thrombocytopenia, treatable by
39
•
•
platelet transfusion.
If only a transfusion of platelets, other blood cells, or plasma was received by the partner,
then the correct answer to this question is “No”; and the question below about transfusion
recipient should be answered “Yes” if the partner was also known to be HIV infected.
Refer to Protocol for Evaluation of Identification and Follow-up of Cases of Public Health
Importance at http://www2a.cdc.gov/hicsb/docs/COPHI_Protocol.pdf for more
information.
8.4.3.4 HETEROSEXUAL RELATIONS WITH TRANSFUSION RECIPIENT WITH
DOCUMENTED HIV INFECTION
• This refers to someone with documented HIV infection who received a
transfusion of blood cells (red cells, white cells, platelets) or plasma.
8.5.2
RECEIVED CLOTTING FACTOR FOR COAGULATION DISORDER
• 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, then
the correct answer to this question is “No”; and the question below about blood
transfusion should be answered “Yes.” If “Yes,” please specify disorder.
• If child was born after March 1985 and receipt of clotting factor is the suspected
mode of HIV transmission, alert the state/local NIR coordinator.
9.0 LABORATORY DATA
9.1.3
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).
10.0 CLINICAL
10.1
AIDS INDICATOR DISEASES
• Enter the dates of initial diagnosis of each indicator disease.
• If at all possible, it is important to include both month and year for future trend analysis.
• In rare circumstances, both month and year may not be available. However, if after further
searches the investigator finds that the only documentation of the diagnosis date is the
year, without a designated month, “..” should be entered for the unknown month followed
by the documented year.
• Choosing an arbitrary month is not recommended.
Definitive diagnoses are based on specific laboratory evidence such as histology or
culture.
Methods for the presumptive diagnosis of diseases indicative of AIDS listed in the case
definition supplement are simply suggested guidelines, not requirements. If a method
does not meet the requirements for definitive diagnosis, it meets the requirements for
presumptive diagnosis for those conditions that may be diagnosed presumptively.
Accept any method that the clinician considers diagnostic.
40
11.0 BIRTH HISTORY AVAILABLE (FOR PERINATAL CASES ONLY)
11.4.3
DELIVERY
• 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.
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 (i.e., neural
tube defects, congenital heart defects, esophageal atresia, cleft lip/palate, etc.).
• 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 and
used in the Metropolitan Atlanta Congenital Defects Program and listed below:
Criteria for Inclusion as Reportable Birth Defect:
o 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.
o The structural or genetic birth defect must be diagnosed or its signs or
symptoms recognized within the first year of life.
o The infant must have a gestational age of at least 20 weeks or a birth weight of
at least 500 grams.
o A case must be abstracted by the child’s sixth birthday.
Criteria for Exclusion:
o 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, laboratory, x-ray, cardiac catheterization, and autopsy reports; and notes
and consultations by physicians, nurses, and social and psychologic services.
• In addition, birth defect (i.e., congenital anomalies) information is also collected
on the standard US birth certificate.
41
• 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. For reference, you may request the full copy of the
Metropolitan Atlanta Congenital Defects Program Procedure Manual from HICSB
at (404) 639-2050.
BIRTH DEFECTS CODE
o The 6-digit defect code is based on 3- or 5-digit ICD-9 codes. The ICD-9 code,
which may be available in the child’s medical record, can be used in place of
the 6-digit code. If defects exist, list all on the case report form and enter in the
Comments section. Call CDC’s DHAP Help Desk by phone at (877) 659-7725
for assistance with coding.
o The following is an abbreviated reference list for birth defect coding:
System
Condition
6-digit Codes
Central Nervous
System
Spina Bifida (meningocele)
741.000–
741.990
A04
Anencephaly
740.000–
740.100
A01
Encephalocele
742.000–
742.090
A13
Atrial septal defects
745.510–
745.590
D06
Ventricular septal defects
745.400–
745.490
D05
Pulmonary valve anomalies
746.000–
746.090
D12
Coarctation of the aorta
747.100–
747.190
D26
Aortic valve anomalies
746.300–
746.490
D14
Transposition of the Great
745.100–
D02
Cardiovascular
42
3-digit
Codes
Orofacial
Musculoskeletal
Arteries
745.190
Tetralogy of Fallot
745.200–
742.210
D03
Hypoplastic left heart syndrome 746.700
D18
Cleft palate without cleft lip
749.000–
749.090
F01
Cleft lip with and without cleft
palate
749.100–
749.290
F02
Clubfoot
754.730
J05
Reduction defect of upper limb 755.200–
755.290
K01
Reduction defect of lower limb 755.300–
755.390
K02
Down syndrome
758.000–
758.098
R01
Trisomy 13 (Patau Syndrome)
758.100–
758.198
R02
Trisomy 18 (Edwards
Syndrome)
758.200–
758.298
R03
22q11.2 deletion
758.370
R04
Cataract
743.320–
743.326
B04
Anophthalmos and
microphthalmus
743.000–
743.100
B01
Hypospadius
752.600–
752.607
G02
Anomalies of renal pelvis and
ureter
753.200–
753.290
H06
Ambiguous genitalia
752.700–
752.790
G04
Abdominal Wall
Anomalies
Gastrochisis
756.710
N04
Omphalocele
756.700
N02
Diaphragmatic
Anomalies
Diaphragmatic hernia
756.600–
756.616
N01
Chromosomal
Eye
Genitourinary
Note: To add a birth defect that is not in this abbreviated list, please refer to the codes
from the Metropolitan Atlanta Congenital Defects Program Procedure Manual.
43
11.6.1
MONTH OF PREGNANCY 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
11.10 DID MOTHER RECEIVE ANY OTHER ANTIRETROVIRAL MEDICATION DURING
PREGNANCY?
• A single drug formulation often has multiple names; trade names are in bold. Drug names
include the following, which serves only as a guide. This guide is current as of May
2011: http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDS
Activities/ucm118915.htm
Antiretroviral drugs used in the treatment of HIV infection
Drugs Used in the Treatment of HIV Infection
Multi-class Combination Products
Brand Name Generic Name
Manufacturer Name
Approval
Date
Time to
Approval
Atripla1
Bristol-Myers Squibb and
Gilead Sciences
12-July-06
2.5 months
efavirenz, emtricitabine
and tenofovir disoproxil
fumarate
Nucleoside Reverse Transcriptase Inhibitors (NRTIs)
Brand Name Generic Name
Manufacturer Name
Approval
Date
Time to
Approval
Combivir2
lamivudine and
zidovudine
GlaxoSmithKline
27-Sep-97
3.9 months
Emtriva3
emtricitabine, FTC
Gilead Sciences
02-Jul-03
10 months
Epivir4
lamivudine, 3TC
GlaxoSmithKline
17-Nov-95
4.4 months
Epzicom5
abacavir and lamivudine GlaxoSmithKline
02-Aug-04
10 months
Hivid6
zalcitabine,
Hoffmann-La Roche
dideoxycytidine, ddC (no
longer marketed)
19-Jun-92
7.6 months
44
Retrovir7
zidovudine,
azidothymidine, AZT,
ZDV
GlaxoSmithKline
19-Mar-87
3.5 months
Trizivir8
abacavir, zidovudine,
and lamivudine
GlaxoSmithKline
14-Nov-00
10.9 months
Truvada9
tenofovir disoproxil
fumarate and
emtricitabine
Gilead Sciences, Inc.
02-Aug-04
5 months
Videx EC10
enteric coated
didanosine, ddI EC
Bristol Myers-Squibb
31-Oct-00
9 months
Videx11
didanosine,
dideoxyinosine, ddI
Bristol Myers-Squibb
9-Oct-91
6 months
Viread12
tenofovir disoproxil
fumarate, TDF
Gilead
26-Oct-01
5.9 months
Zerit13
stavudine, d4T
Bristol Myers-Squibb
24-Jun-94
5.9 months
Ziagen14
abacavir sulfate, ABC
GlaxoSmithKline
17-Dec-98
5.8 months
Nonnucleoside Reverse Transcriptase Inhibitors (NNRTIs)
Brand Name
Generic Name
Manufacturer Name
Approval
Date
Time to
Approval
Edurant
rilpivirine
Tibotec Therapeutics
20-May-11
10 months
Intelence15
etravirine
Tibotec Therapeutics
18-Jan-08
6 months
Rescriptor16
delavirdine, DLV
Pfizer
4-Apr-97
8.7 months
Sustiva17
efavirenz, EFV
Bristol Myers-Squibb
17-Sep-98
3.2 months
Viramune18
(Immediate
Release)
nevirapine, NVP
Boehringer Ingelheim
21-Jun-96
3.9 months
Viramune XR19 nevirapine, NVP
(Extended
Release)
Boehringer Ingelheim
25-Mar-11
9.9 months
Brand Name Generic Name
Manufacturer Name
Approval
Date
Time to
Approval
Agenerase20
amprenavir, APV
GlaxoSmithKline
15-Apr-99
6 months
Aptivus21
tipranavir, TPV
Boehringer Ingelheim
22-Jun-05
6 months
Protease Inhibitors (PIs)
45
Crixivan22
indinavir, IDV,
Merck
13-Mar-96
1.4 months
Fortovase23
saquinavir (no longer
marketed)
Hoffmann-La Roche
7-Nov-97
5.9 months
Invirase24
saquinavir mesylate,
SQV
Hoffmann-La Roche
6-Dec-95
3.2 months
Kaletra25
lopinavir and ritonavir,
LPV/RTV
Abbott Laboratories
15-Sep-00
3.5 months
Lexiva26
Fosamprenavir Calcium, GlaxoSmithKline
FOS-APV
20-Oct-03
10 months
Norvir27
ritonavir, RTV
Abbott Laboratories
1-Mar-96
2.3 months
Prezista28
darunavir
Tibotec, Inc.
23-Jun-06
6 months
Reyataz29
atazanavir sulfate, ATV
Bristol-Myers Squibb
20-Jun-03
6 months
Viracept30
nelfinavir mesylate, NFV Agouron Pharmaceuticals
14-Mar-97
2.6 months
Fusion Inhibitors
Brand Name Generic Name
Manufacturer Name
Approval
Date
Time to
Approval
Fuzeon31
Hoffmann-La Roche &
Trimeris
13-Mar-03
6 months
Time to
Approval
enfuvirtide, T-20
Entry Inhibitors - CCR5 co-receptor antagonist
Brand Name Generic Name
Manufacturer Name
Approval
Date
Selzentry32
Pfizer
06-August-07 8 months
maraviroc
HIV integrase strand transfer inhibitors
Brand Name Generic Name
Manufacturer Name
Approval
Date
Time to
Approval
Isentress33
Merck & Co., Inc.
12--Oct-07
6 months
raltegravir
Generic drugs used in the Treatment of HIV Infection34
Drugs Used in the Treatment of Pediatric HIV Infection35
Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan
(PEPFAR)
46
•
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 http://www.aidsinfo.nih.gov/guidelines/.
11.12.2 MATERNAL SOUNDEX
• If name of the patient’s biological mother has not been entered in the database,
enter name and date of birth in the CDC-supplied software.
• The biological mother’s surname will be converted to a SOUNDEX CODE when
entered into the CDC-supplied software.
• If name of the biological mother has been entered in your database and a “stateno”
exists, retrieve the soundex code from the database and enter here.
• Consult with your state/local health department in jurisdictions with alternatives to
name-based reporting.
11.12.4 MATERNAL COUNTRY OF BIRTH
• Select first from boxes provided:
United States
US dependency, specify
Other, specify
Unknown
• For patients born in US dependencies, specify from the following table:
American Samoa
Guam
Johnston Atoll
Mariana Islands
Marshall Islands
Micronesia
Midway Islands
Navassa Island
US dependencies
Pacific Trust Terr.
Palau
Puerto Rico
Ryukyu Islands
Swan Islands
US Virgin Islands
Wake Island
12.0 SERVICES REFERRAL
12.1.1
NEONATAL ARVs FOR HIV PREVENTION
• The neonatal component of the ACTG protocol 076 consisting of 6 weeks of
neonatal prophylactic ARV therapy should begin within 24 hours of birth.
Therefore, to monitor implementation and impact, we collect the day, month, and
year the child was first started on ARV for prophylaxis.
If “Yes,” record the day, month, and year the child was started on ARVs as
prophylaxis during the first 6 weeks of life.
If search for day was unsuccessful and year and month are present, then enter
“..” for the unknown day followed by the documented year and month.
Examples include Didanosine (ddI, dideoxyinosine, Videx), Dideoxycytidine
(ddC, HIVID, Zalcitabine), Lamivudine (3TC, Epivir), Stavudine (d4t, Zerit),
47
Nevirapine, Indinavir (Crixivan), Ritonavir, and Saquinavir (Invirase).
12.1.2
ANTI-RETROVIRAL THERAPY FOR HIV TREATMENT
• Please refer to the Guidelines for the Use of Antiretroviral Agents in Pediatric
HIV Infection
http://aidsinfo.nih.gov/Guidelines/GuidelineDetail.aspx?GuidelineID=8
12.1.3
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.
12.2
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.
12.3
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.
•
“Adoptive parent, relative” refers to child who has been legally adopted by a relative. This
includes children with dead 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 dead 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
Purpose of Pediatric HIV Exposure Reporting form
The Pediatric HIV Exposure Reporting form is to collect information on Pediatric Exposure Reporting.
The form facilitates collection of additional standardized data on HIV-exposed children related to
prevention of perinatal transmission beyond those in collected and stored in state eHARS systems. This
guidance applies data collection even if surveillance sites use a different form or medium for HIV case
48
surveillance. See Appendix for further details. Information on children who are perinatally exposed to
HIV or who have HIV or 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.
Disposition of form
• The completed form is for state or local health agency use and is not to be sent to the Centers
for Disease Control and Prevention (CDC) with patient identifiers.
• Data obtained from these forms are entered into compatible or standardized computer
software provided by the Division of HIV/AIDS Prevention, National Center for HIV, Viral
Hepatitis, STD, and TB Prevention, CDC, linked to maternal records and then transferred
without identifiers to CDC electronically by encrypted electronic transfer via secure data
network.
Chart abstraction guidance
Think critically about the data you are abstracting. The information should make sense overall. For
example, the dates of receipt of prenatal care, CD4 and viral load testing, receipt of antiretrovirals should
make sense based on the infant’s date of birth. If you find inconsistent information in the medical records
indicate that information in the comments section on the data abstraction form. This will let us know that
the inconsistency was in the medical record and is not an error with the abstraction, notation, or data entry
of the information. 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 must be familiar with the various components of the medical record
(demographic/financial information, doctor’s progress or S.O.A.P. notes, prenatal care
records, labor & delivery records, nurse’s notes, operative notes, lab results section,
discharge summaries, problem lists, drug lists, etc.)
•
Abstractors need to be familiar with medical abbreviations and terminology, especially as
related to HIV.
•
Abstractors need to be familiar with the procedures required to abstract records from the
various providers/facilities.
•
Abstractors must be trained in confidentiality and security procedures and sign a statement
to that effect. Most health departments and academic institutions have such training in
existence and methods in place to document completion of this training.
•
Records to be Abstracted
At a minimum the following records should be reviewed. There may be particular instances
where other records are also reviewed (i.e., STD records, Health Department Records)
Mother
Infant
Maternal prenatal records
Pediatric birth records (hospital records)
49
Maternal labor and delivery records
Birth certificate
Maternal HIV clinic records
Pediatric medical records (HIV clinic, non HIV
clinic, 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 any chart at all on the mother, the Enhanced Surveillance
Form should still be filled out and Questions 1, 2, and 3 should be completed as much
as possible.
•
If information on the mother is available in the infant’s chart but also in the mother’s
chart, use the mother’s chart as the ‘gold standard’ for questions related to the mother’s
care.
Abstraction of Infant’s Record
•
Complete this form only for live births. It is not feasible for surveillance to collect data for
all pregnancies (which would include fetal loss). 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), a separate eHARS and
supplemental exposure reporting form should be used for each infant, but the maternal
information only needs to be abstracted on one form.
Follow-up Chart Review
You will be reviewing 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, be sure to abstract all data needed for eHARS updates (e.g., HIV diagnostic tests,
CD4 counts, treatment, prophylaxis, AIDS-defining conditions, birthweight, vital status, birth
defects, etc). You will need to complete a new EPS form documenting the updates. On the
additional EPS form you should complete the demographics section for both the mother and the
infant and then only 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.
50
Indicating ‘Unknown’
A ‘99’ should be checked or written in if you wish 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.
Record Not Available
Record not available should only be selected if the information cannot be obtained from any
record source and the primary record as indicated in the hierarchy at the beginning of each section
is not available.
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, ‘ ’
(blank) should be entered into the appropriate space (e.g., 02/../2005). No not use ‘99” to indicate
unknown/missing dates. Be sure the dates indicated on the form make sense. For example, be
sure that the infant’s date of birth is consistent with the date of delivery indicated and that the
dates of receipt of prenatal care, CD4 and viral load testing, receipt of antiretrovirals, etc make
sense based on this date of birth.
Records That Are ‘Not Available’
Records will be considered ‘not available’ after two separate 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.
Conflicting Information
The chart which could be considered the gold standard for a specific question depends on the
question itself. An example of a situation which may arise is as follows: the maternal obstetrical
chart and the HIV chart may have different dates for receipt of prenatal care. We recommend that
you use the information from the obstetrical chart. Similarly, if there are different start dates for
administration of ARV, use the HIV infectious disease (HIV/ID) chart as the gold standard 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). Therefore, 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.
Error Correction
51
When correcting errors on the abstraction form, draw a single line through the error and write the
correct information next to or above it. Please do not attempt to write the correct information over
top of the original line, making it hard to decipher which is the correct information. It is also best
not to use ‘white out’. Confidential information written anywhere in the form margins can usually
be covered by black ink selecter.
Required Fields
Infant state number is required on the abstraction form for linkage to eHARS data and as a quality
control tool to avoid duplicative record entry.
Text boxes
Enter comments, specifics, or additional information (missing values can be left blank or entered
using two periods [..]).
INFORMATION COMPLETE FOR ANALYSIS: (Y/N)
A ‘Yes’ response indicates that the data included on the data abstraction form is ready to be
included in the analysis dataset. Whether or not the data is ready is a decision which should be
made by the Perinatal Coordinator, Surveillance Coordinator, or another designee, not the data
entry specialist. The following guidelines will be helpful in deciding if the data is ready for
analysis:
•
An attempt has been made to abstract all available records. If minimal information is
available and there are no further resources for obtaining information, the form may be
judged as ‘complete for analysis’ even though information on the mother and infant is
incomplete.
•
Information through the birth history should have been obtained.
•
Completeness should be judged based on what information is abstracted that is most
helpful to the state in performing any particular analysis.
•
Note: Expected follow-up, such as documented HIV serostatus, will come later.
1. If information on the mother is not available, was the child adopted, or in foster care?
•
2.
Select appropriate response from legal values “Yes”, “No”, or “Not applicable”.
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’
Records abstracted
52
•
3.
Weeks’ gestation at first prenatal care visit
•
•
4.
For each type of record, code whether it was - abstracted (1), attempted but record was not
available (2), not abstracted (3), or attempted, will try again (4). Do not simply indicate an X
for each record abstracted
Enter value in weeks, by calculating difference between estimated date of conception and date
of first prenatal care visit.
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.
Was the mother screened for any of the following during pregnancy?
(Reference: Red Book 2000- American Academy of Pediatrics) Use test done prior to birth but
closest to delivery date or at admission for labor and delivery.
•
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 & rectal GBS
colonization, offering intrapartum chemoprophylaxis to those identified as GBS
carriers OR
risk factor based strategy - prophylaxis given to women with intrapartum risk
factors: gestation < 37 weeks, ≥ 18 hours since rupture of membrane, temperature
38° C or greater.
•
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
53
•
•
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 & delivery for high risk women and women whose status is
unknown.
Rubella - Screening usually done at the initial prenatal visit. If ‘negative’ the mother
should be immunized.
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. For more
information about syphilis see Q.5.
5. Diagnosis (for the mother) of the following conditions during this pregnancy or at the time of
labor and delivery
5.0 For this question, “diagnosed” refers to newly diagnosed, had a recurrence of, or had chronic
infection with any of the following conditions. Screening for syphilis, gonorrhea, and chlamydia
is done during prenatal care. Generally a diagnosis of an STD will show up in a number of places
in the chart including progress notes, 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 of public health clinics). Diagnoses may be
presumptive or definitive depending on various signs, 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:
•
5.1 Bacterial vaginosis - Clinician diagnosis of bacterial vaginosis. Sometimes
abbreviated BV.
•
5.2 Chlamydia (Chlamydia trachomatis) - Record positive test for chlamydia
(either a positive culture, positive EIA, or detection of chlamydial antigen or
nucleic acid).
54
•
•
•
•
•
•
•
Name of lab tests - Chlamydia cell culture (TRIC Agent Culture); direct
fluorescent antibody (DFA) tests; enzyme immunoassay (EIA) tests;
nucleic hybridization (DNA probe) tests, PCR and LCR.
Genital Herpes - Active (herpes genitalis) - Record as a ‘Yes’ if the woman
has 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); Thayer-Martin 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 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 & 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, temperature 38° C or greater.
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 (anti-HBe) . Usually done at the initial prenatal visit or at the time of
labor & delivery for high risk women and women whose status is unknown.
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).
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.
Syphilis (Treponema pallidum) - All pregnant woman should receive serologic
screened 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 risk 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),
55
•
6.
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 FTA-ABS or MHA-TP usually remain 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/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; Microhemagglutination, Treponema
Pallidum.
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.
Mother's reproductive history
6.0 To specify ‘Not Documented’ enter ‘ND’. 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 of the woman’s past pregnancies.
•
Number of previous pregnancies: This number should include all pregnancies,
regardless of outcome (including abortions, miscarriages, etc) up to but
EXCLUDING the pregnancy that is being abstracted.
•
Number of previous live births: Note that parity 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. The number of live births should be the total of preterm and term births
(excluding abortions, miscarriages, and stillbirths).
•
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.
56
•
•
•
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: 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 G 5 P 3 or it may be written as G 5 P 3 A 1 .
The ‘G’ (gravida) refers to the 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.
o G = gravida, the number of pregnancies including the current pregnancy
o P = parity, the number of pregnancies > 20 weeks gestation (excludes
miscarriages and 1st trimester abortions)
o A = Abortion, the number of abortions (both spontaneous and induced
abortions)
For example, a woman who is G 5 P 3 A 1 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)
57
2nd digit = preterm pregnancies (20-37 weeks)
3rd digit = abortions (includes both spontaneous and induced abortions)
4th digit = living children
For example, a woman’s record may read G 5 P 2113 . This woman has delivered 2
infants who were full-term, 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.
•
7.
Complete the chart for all siblings.
•
8.
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.
If possible, record the dates of birth of live born siblings. This information is not always
available on prenatal care charts or labor and delivery records. This question is included
because of limitations in the current eHARS software (v3.3) which allow only for the linking
of one child with the mother’s eHARS case report.
Substance use during pregnancy noted
•
This section on substance abuse provides information on whether substance abuse occurred
during the mother’s pregnancy. This information can be found in the progress notes, social
worker notes, and in the lab results summary section, or in the summary sheet listing all
58
prenatal care visits, lab results, gestational ages, etc.
Select appropriate response(s) from legal values, “Yes”, “No”, “Record not available”,
or unknown.
o The drugs listed here are in alphabetical order. 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.
o If any drugs are used, populate the field at Q. 8b from given legal values. If any
drug(s) used were injected, select ‘Yes’ and write the name of the drug in the
space provided.
9.
Was a toxicology screen done on the mother (either during pregnancy or at the time of
delivery)? 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. Marijuana may be listed on the
toxicology results as cannabis, as a cannabinoid, THC or simply marijuana. Heroin is a semisynthetic
narcotic and opiate and should be listed as heroin or opiate on the toxicology lab results sheet.
•
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.
10. Was a toxicology screen done on the infant at birth? 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 clearly noted in the infant's birth chart.
•
Select all drugs identified on screening, including methadone. If screening for ‘Other’ drug
was done, specify the drug metabolites in the space provided.
59
11. Was the mother's HIV serostatus noted in her prenatal care medical records?
•
•
•
This information may be found in the history or progress notes, or on a lab report.
Select ‘Yes, HIV-Positive’ if there is indication of a positive Western Blot, a positive ELISA,
a positive PCR for HIV, a positive HIV culture, or an HIV viral load result > 0. Or,
medication records may indicate the mother is receiving ARV.
Select ‘Yes, HIV-Negative’ if there is indication of a negative test during pregnancy or at
labor and delivery.
12. Antiretroviral drugs prescribed for the mother during this pregnancy?
12. Were antiretroviral drugs prescribed for the mother during this pregnancy?
Yes (Complete table.)
No (Go to 12a.) Not documented (Go to 13.)
Record not available (Go to 13.)
Drug name
(See list on p. 8.)
Other
(specify)
Unknown
Drug
refused
Date drug started
(mm/dd/yyyy)
Gestational age
drug started
(weeks; round down)
i. _______________ ___________
__ __/__ __/__ __ __ __
____________
ii. _______________
__________
__ __/__ __/__ __ __ __
iii.________________
__________
iv.________________
__________
v.________________
vi.________________
Drug stopped
Yes No ND
Date stopped
(if yes in preceding column)
(mm/dd/yyyy)
Stop codes
(See list on
p. 8.)
__ __/__ __/__ __ __ __
________
____________
__ __/__ __/__ __ __ __
________
__ __/__ __/__ __ __ __
____________
__ __/__ __/__ __ __ __
________
__ __/__ __/__ __ __ __
____________
__ __/__ __/__ __ __ __
________
__________
__ __/__ __/__ __ __ __
____________
__ __/__ __/__ __ __ __
________
__________
__ __/__ __/__ __ __ __
____________
__ __/__ __/__ __ __ __
________
12a. If no antiretroviral drug was prescribed during pregnancy, check reason.
No prenatal care
Mother known to be HIV-negative during pregnancy Not documented
Unknown
HIV serostatus of mother unknown Mother refused
•
Other (Specify.)
‘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. Select ‘no ’ if no
ARV was prescribed in pregnancy.
o
IF NO ARV WAS PRESCRIBED IN PREGNANCY, INDICATE REASON:
o No prenatal care - The mother did not receive any prenatal care during her
pregnancy.
o 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.
o 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
60
•
in the chart; do not use patient report.
o Mother Refused - Mother refused ARV during pregnancy.
o Other - If ‘Other’ is indicated, be sure to specify why ARV was not
prescribed.
o Not Documented - Indicate ‘Not Documented’ if the woman was not
prescribed ARV but the reason why is not known.
Enter ‘Unknown’ in the ‘Drug Name’ column if the specific drugs she received are
unknown.
Antiretroviral Drug List: There is a reference list of antiretroviral drugs included at the end of
the data abstraction form. In this list, the drugs are organized by drug category, NNRTI,
NRTI, Protease Inhibitors, and Other, and within each category the drugs are listed in
alphabetical order. As new drugs become available the drug list in the database will be
updated. Call the Enhanced Perinatal Surveillance Coordinator at CDC to report drugs that
are not included in the list.
Drug Name - Using the antiretroviral drug list, 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, be sure to 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 ‘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 were not prescribed drugs and those who were
not prescribed drugs because they refused it.
Date Drug Started - Enter ‘XX’ for unknown values (i.e., 03/XX/2005). In the case
of a woman having interrupted antiretroviral 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, i.e., if medical chart
indicates 37 4/7 weeks, 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.
Date Stopped - Enter date (MM/DD/YYYY) the antiretrovirals were stopped if
completely discontinued. If date is not documented then indicate ‘ND’.
Drug Stop Code - To answer this question, use the ‘S’ codes found at the end of the
abstraction form. Please see Appendix 2, p. 5 Up to two codes are allowed as
reasons why a drug may be stopped. If there are more than two reasons why a drug
is stopped, indicate the two most important reasons. Code the reasons as they are
61
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.
13. Was mother's HIV serostatus noted in her labor and delivery records?
13. Select appropriate response from given legal values.
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 will indicate, however, she was known
to be HIV-infected during her pregnancy – in such cases, check ‘Yes, Positive’.
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
o
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.
o
Woman may have been tested before delivery, but appears not to be known to
be HIV-infected 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?
14. Did mother receive antiretroviral drugs during labor and delivery?
Yes (Complete table.)
Drug Name
No (Go to 14a.)
Other
(See list.)
(specify)
Drug
refused
Not documented (Go to 15.)
Record not available
(Go to 15.)
Unknown
Date received
Time received
(mm/dd/yyyy)
(See military time.)
Oral
Type of administration
IV
Not documented
i. ___________________
____________
__ __/__ __/__ __ __ __
__ __:__ __
ii. __________________
____________
__ __/__ __/__ __ __ __
__ __:__ __
iii. __________________
____________
__ __/__ __/__ __ __ __
__ __:__ __
iv. __________________
____________
__ __/__ __/__ __ __ __
__ __:__ __
v. __________________
____________
__ __/__ __/__ __ __ __
__ __:__ __
vi. __________________
____________
__ __/__ __/__ __ __ __
__ __:__ __
14.0 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.
•
Select suitable response from given legal values, “Yes”, “No”, and “Not documented”,
“Record not available”, and “Unknown”.
62
•
•
•
•
•
•
Select ‘Yes’ if ARVs received during the intrapartum period, and complete the grid for
all drugs received during labor and delivery. Enter “Unknown” in the ‘Drug Name’
column if the specific drugs received are unknown, complete the grid and write
‘Unknown”.
If the specific drugs she received or refused are unknown, complete the grid and write
‘Unknown” in the ‘Drug Name’ column. Also, be sure to enter receipt of ARVs at
labor and delivery in EHARS.
Select “No” if no ARV 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 csection’.
HIV status 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.
Antiretroviral Drug List: A reference list of antiretroviral drugs appears at the end of
the data abstraction form (Please see Appendix 2, page 5). In this list, the drugs are
organized by drug category, NNRTI, NRTI, Protease Inhibitors, and Other, and within
each category the drugs are listed in alphabetical order. As new drugs become
available the drug list in the database will be updated. Contact the CDC subject matter
expert for Perinatal Surveillance to report drugs not included in the list; this SME may
be reached through your jurisdiction’s HIV Surveillance Coordinator or by calling the
HIV Incidence and Case Surveillance Branch’s main number (404) 639-2050.
63
15. Was mother referred for HIV care after delivery?
15.0 If the mother receives CD4 or viral load testing (Q. 16a and 16b) this information can be used
as a marker that the mother received care after delivery. This question refers to the time 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 result or first viral load after discharge from hospital (up to 6
months after discharge).
16.0This 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 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 result, mark ‘Not
Done’.
If there is no indication of a subsequent viral load result, mark ‘Not Done’.
17. Birth information
17.0 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 p.m. is
21:15--It is easy to calculate by adding 12 to each hour after 12 noon (1:00 p.m. is 13:00, etc...).
Midnight is 00:00. Minutes after midnight are coded as 00:01 etc... (i.e., fifteen minutes after
midnight is 00:15).
Onset of labor - This should be easily found on the labor and delivery summary
sheet. The onset of labor is defined as the time when contractions are 3-5 minutes
apart. Note the date as well as the time --both 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 L/D - Time of admission should be available on the face sheet
64
(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 easily found on the labor and delivery
summary sheet. Note the date as well as the time -- both are necessary to calculate
the duration of ruptured membranes and duration 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, or SROM; or PROM which refers to premature rupture of
membranes. In the case of cesarean section, the rupture of membranes may be
almost concurrent with time of delivery.
Delivery - This should be easily found on the labor and delivery summary sheet.
Note the date as well as the time -- both 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, you will have to verify the correct date of birth and
update eHARS if necessary.
18. If Cesarean delivery, select all the following indications that apply.
•
•
•
•
Select the appropriate response from given legal values.
If not documented, select ‘Not specified’.
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. Whether
cesarean was the mode of delivery may usually be noted there.
Elective cesarean section refers to a cesarean section that occurs before rupture of membranes
and before the onset of labor. However, if a Cesarean Section was planned but then performed
ahead of schedule due to unexpected circumstances, it will still be coded as ‘Elective.’ Nonelective (or emergent) C-sections are usually done because the fetus has shown signs of
distress during labor, whereas elective C-sections are planned, because of previous C-section,
breech position, HIV prevention, etc. and usually occur before the onset of labor. C-sections
that are done in the middle of the night are usually not elective--review 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
65
in the child’s records are acceptable even if no birth records are available.
19. Was mother's HIV serostatus noted on the child's birth record?
• Select appropriate response from given legal values.
20. Antiretroviral drugs prescribed for the child during the first 6 weeks of life.
20. Were antiretroviral drugs prescribed for the child during the first 6 weeks of life?
Yes (Complete table.) No (Go to 20a.) Not documented Record not available Unknown
Drug name
(See list on p. 8.)
Other
(specify)
Drug
refused
Date drug started
(mm/dd/yyyy)
Time started
(See military
time.)
ART
Completed?
Yes No ND UNK
Stop date
(if therapy not completed)
(mm/dd/yyyy)
Stop codes
(See list on
p. 8.)
i._________________ ____________
__ __/__ __/__ __ __ __
__ __:__ __
__ __/__ __/__ __ __ __
________
ii.________________ _____________
__ __/__ __/__ __ __ __
__ __:__ __
__ __/__ __/__ __ __ __
________
iii.________________ ____________
__ __/__ __/__ __ __ __
__ __:__ __
__ __/__ __/__ __ __ __
________
iv.________________ ____________
__ __/__ __/__ __ __ __
__ __:__ __
__ __/__ __/__ __ __ __
________
v.________________ _____________
__ __/__ __/__ __ __ __
__ __:__ __
__ __/__ __/__ __ __ __
________
vi.________________ ____________
__ __/__ __/__ __ __ __
__ __:__ __
__ __/__ __/__ __ __ __
________
•
•
•
The first six weeks of life are referred to as the neonatal period. Do not include here any
antiretroviral medications received after the first six weeks of life.
Select appropriate response from given legal values, “Yes”, “No”, “Not documented”,
“Record not available”, or “Unknown”.
Select “Yes” if ARV were prescribed, and complete the grid.
Select “Unknown” if the specific drugs prescribed are unknown, complete the grid,
and write “Unknown” in the “Drug name” column.
If no ARV prescribed during first 6 weeks, indicate reason
HIV status 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
66
ARV but the reason why is not known.
.
67