Download:
pdf |
pdfAttachment 4(d)
Adult and Pediatric HIV/AIDS Confidential Case Reports
for National HIV/AIDS Surveillance OMB No. 0920-0573
Supplemental Surveillance Activity 3: Enhanced Perinatal Surveillance (EPS)
Summary of Form Changes and EPS User Guide Instructions for Data Abstraction Form
1
Listing of Changes to EPS Form
5/26/2009
I. Summary of Changes
•
•
•
•
•
•
Title of form Enhanced HIV/AIDS Surveillance to Maximally Reduce Perinatal HIV Transmission
changed to: Enhanced Perinatal Surveillance (EPS)
Burden statement will be updated to 60 minutes
Format of the form was changed to include check boxes and clear delineation of sections
Removed designation of HARS or M-HARS after specific variables
Public burden statement moved to end of form from first page
Addition of list of abbreviations to the last page
List of abbreviations
ACTG
ART
EIA
HARS
HMO
ICD-9
ICD -10
IFA
ND
NNRTI
AIDS Clinical Trials Group
antiretroviral therapy
enzyme immunoassay
HIV/AIDS Reporting System
health maintenance organization
International Classification of Diseases, Ninth Revision
International Classification of Diseases, Tenth Revision
immunofluorescent assay
not documented
nonnucleoside reverse transcriptase inhibitor
NRTI
NRR
OB-GYN
PCP
PI
PID
STAT
WB
nucleoside reverse transcriptase inhibitor
no risk factor reported
obstetric-gynecologic or obstetrician-gynecologist
Pneumocystis jirovecii pneumonia [jirovecii is now preferred to carinii;
abbreviation is the same]
protease inhibitor
pelvic inflammatory disease
immediately (statim)
Western blot
This report to the Centers for Disease Control and Prevention (CDC) is authorized by law (Sections 304 and 306 of the Public Health Service Act, 42 USC 242b and 242k). Response in this case is voluntary for federal
government purposes, but may be mandatory under state and local statutes. Your cooperation is necessary for the understanding and control of HIV/AIDS. Information in CDC’s HIV/AIDS surveillance system that would
permit identification of any individual on whom a record is maintained is collected with a guarantee that it will be held in confidence, will be used only for the purposes stated in the assurance on file at the local health
department, and will not otherwise be disclosed or released without the consent of the individual in accordance with Section 308(d) of the Public Health Service Act (42 USC 242m).
II. Changes to specific questions (changes indicated in highlighted (yellow) areas)
1. Records abstracted: (REQUIRED FIELD)
(1=Abstracted, 2=Attempted, but record not available, 3=Not abstracted, 4=Attempted, will try again)
___ Prenatal care records
___ Pediatric medical records (non HIV clinic/provider)
___ Maternal HIV clinic records
___ Birth certificate
___ Labor and delivery records
___ Death certificate
___ Pediatric birth records
___ Health department records
___ Pediatric HIV medical records
___Other, specify__________
Changed to:
1. Records abstracted (Required)
(1 = Abstracted, 2 = Attempted—record not available, 3 = Not abstracted, 4 = Attempted—will try again)
____ Prenatal care records
____Pediatric medical records (non-HIV clinic or provider)
____ Maternal HIV clinic records
____Birth certificate
____ Labor and delivery records
____Death certificate
____ Pediatric birth records
____Health department records
____Pediatric HIV medical records
____Other (Specify.)
Description of changes above:
The word FIELD was removed. 2=Attempted, but record not available,
Changed to 2 = Attempted—record not available;
___ Pediatric medical records (non HIV clinic/provider)
Changed to ___Pediatric medical records (non-HIV clinic or provider)
2. Infant
Soundex _____________________
Changed to Soundex code
Description of change above: The word code was added
Sex at Birth ____ (HARS)
Changed to
Sex at birth
M F
Description of change above: Male and female options were added
3. Mother
Soundex _____________________
Changed to
Soundex code
Description of change above: The word code was added
4a. If Country is unknown, but Continent of birth is known, specify ______________________
Changed to
4a. If mother’s country of birth is not specified, list continent of birth if known.
Description of change above: Minor changes in wording
6. Mother's Race (Mark all that apply) (M-HARS-modified)
Hawaiian/Pacific Islander
Changed to
Hawaiian/Other Pacific Islander
Other Race, specify ___________________
Changed to
Other (Specify.) _______
Description of change above:
Other was added to Pacific Islander
Race was added to Other (Specify.) _______
8. Mother's HIV risk factor (Mark all that apply) (HARS)
Injection drug user (IDU)
Person with hemophilia
Heterosexual contact with IDU
Heterosexual contact with bisexual male
Heterosexual contact with person with hemophilia
Heterosexual contact with transfusion recipient with documented HIV
Heterosexual contact with transplant recipient with documented HIV
Heterosexual contact with male with HIV/AIDS with unknown risk
Transfusion recipient
Transplant recipient (tissue/organ or artificial insemination)
Perinatal Exposure (e.g. mother was perinatally infected)
Unknown/Other documented risk (discuss with NRR Coordinator within your State)
If Other, specify __________________________________________________
Changed to
8. Mother's HIV risk factor (Mark all that apply.) Heterosexual contact with (cont)
Injection drug use
HIV-infected male, risk factor not specified
Heterosexual contact with
Hemophilia with documented HIV
injection drug user
Receipt of transfusion
bisexual male
Receipt of transplant(tissue/organ or artificial insemination)
male with hemophilia with documented HIV Perinatal exposure (i.e. mother was perinatally infected)
transfusion recipient with documented HIV infection Unknown
transplant recipient with documented HIV infection
Other documented risk (Discuss with the NRR coordinator in your state.)
If Other, specify____________
Description of changes above: change in formatting and minor word changes not changing meaning of responses
9. Did mother receive any prenatal care for this pregnancy?
Yes
No (Go to Q15)
Not Documented (Go to Q15)
Changed to:
9. Did mother receive any prenatal care for this pregnancy?
Yes
No (Go to 15.)
Not documented (Go to 15.) Unknown
Description of changes above: This question added an unknown option
12. Date of last prenatal care visit prior to delivery: __ __/__ __/__ __ __ __ (mm/dd/yyyy)
Changed to:
12. Date of last prenatal care visit before delivery
__ __/__ __/__ __ __ __ (mm/dd/yyyy)
Description of changes above: Prior to changed to before
13. Number of prenatal care visits: (e.g., visits specifically for prenatal care) ______ (99=unk) (HARS)
Changed to:
13. Number of prenatal care visits (99 = unknown)
Description of changes above: e.g., visits specifically for prenatal care) was removed from this question
14. In what type of facility was prenatal care primarily delivered? (Mark only one)
OB/GYN clinic
Correctional facility
Adult HIV specialty clinic
ACTG site
HMO clinic (for prenatal care)
Other, specify _________________________
Private care (OB/GYN, midwife)
Not Documented
Changed to:
14. In what type of facility was prenatal care primarily delivered? (Check only one box.)
OB/GYN clinic
Private care (OB/GYN, midwife) Other (Specify.) _________________
Adult HIV specialty clinic
Correctional facility
Not documented
HMO clinic (for prenatal care) ACTG site
Unknown
Description of changes above: This question added an unknown option
15. Was the mother screened for any of the following during pregnancy?
(Use test done prior to birth but closest to delivery date or at admission for labor & delivery)
Yes
Date (mm/dd/yyyy)
No
Not Documented
Record Not Available
Group B Strep
__ __/__ __/__ __ __ __
Hepatitis B (HBsAg)
__ __/__ __/__ __ __ __
Rubella
__ __/__ __/__ __ __ __
Syphilis
__ __/__ __/__ __ __ __
Changed to:
15. Was the mother screened for any of the following during pregnancy?
(Check test performed before birth, but closest to date of delivery or admission to labor and delivery.)
Yes Date (mm/dd/yyyy) No Not documented Record not available Unknown
Group B strep
__ __/__ __/__ __ __ __
Hepatitis B (HBsAg) __ __/__ __/__ __ __ __
Rubella
__ __/__ __/__ __ __ __
Syphilis
__ __/__ __/__ __ __ __
Description of changes above: This question added an unknown option
16. Mother’s diagnosis of the following conditions during this pregnancy or at the time of labor and delivery.
See "Instructions for Data Abstraction" for definitions.
Yes Date of Diagnosis
No
Not Doc
RNA
(mm/dd/yyyy)
Bacterial vaginosis
__ __/__ __/__ __ __ __
Chlamydia
__ __/__ __/__ __ __ __
Genital Herpes
__ __/__ __/__ __ __ __
Gonorrhea
__ __/__ __/__ __ __ __
Group B Strep
__ __/__ __/__ __ __ __
Hepatitis B (HbsAg+)
__ __/__ __/__ __ __ __
Hepatitis C
__ __/__ __/__ __ __ __
Pelvic Inflammatory Disease (PID)
__ __/__ __/__ __ __ __
Syphilis
__ __/__ __/__ __ __ __
Trichomonas
__ __/__ __/__ __ __ __
Changed to:
16. Diagnosis (for the mother) of the following conditions during this pregnancy or at the time of labor and
delivery
(See Instructions for Data Abstraction for definitions.)
Yes
Date of diagnosis
No Not documented Record not available Unknown
(mm/dd/yyyy)
Bacterial vaginosis
__ __/__ __/__ __ __ __
Chlamydia trachomatis infection
__ __/__ __/__ __ __ __
Genital herpes
__ __/__ __/__ __ __ __
Gonorrhea
__ __/__ __/__ __ __ __
Group B strep
__ __/_ __/__ __ __ __
Hepatitis B (HbsAg+)
__ __/__ __/__ __ __ __
Hepatitis C
__ __/__ __/__ __ __ __
PID
Syphilis
Trichomoniasis
__ __/__ __/__ __ __ __
__ __/__ __/__ __ __ __
__ __/__ __/__ __ __ __
Description of changes above:
Chlamydia Changed to Chlamydia trachomatis infection
Pelvic Inflammatory Disease (PID)
Changed to
PID
Trichomonas
Changed to
Trichomoniasis
This question added an unknown option
18. Complete the chart below for all siblings:
DOB
(mm/dd/yyyy)
Age
yrs:mos as of mm/yy
HIV
Status*
State no.
City no.
Sib 1
__ __/__ __/__ __
___:___ as of ___/___
____
______________
__________
*HIV Status:
Sib 2
__ __/__ __/__ __
___:___ as of ___/___
____
______________
__________
Sib 3
__ __/__ __/__ __
___:___ as of ___/___
____
______________
__________
Sib 4
__ __/__ __/__ __
___:___ as of ___/___
____
______________
__________
[1] Infected
[2] Uninfected
[3] Indeter-minate
[9] Not
Documented
Sib 5
__ __/__ __/__ __
___:___ as of ___/___
____
______________
__________
Sib 6
__ __/__ __/__ __
___:___ as of ___/___
____
______________
__________
–
Changed to:
18. Complete the chart for all siblings.
Date of birth
(mm/dd/yyyy)
Age
(yrs: mos as of mm/yyyy)
HIV serostatus
(See list.)
State No.
City No.
__ __/__ __/__ __ __ __
___:___ as of __ __/__ __ __ __
_______________
____________________
_______________________
__ __/__ __/__ __ __ __
___:___ as of __ __/__ __ __ __
______________
_____________________
_______________________
__ __/__ __/__ __ __ __
___:___ as of __ __/__ __ __ __
_______________
____________________
_______________________
__ __/__ __/__ __ __ __
___:___ as of __ __/__ __ __ __
______________
_____________________
________________________
__ __/__ __/__ __ __ __
___:___ as of __ __/__ __ __ __
_______________
____________________
_______________________
__ __/__ __/__ __ __ __
___:___ as of __ __/__ __ __ __
______________
_____________________
________________________
HIV serostatus: 1 = Infected, 2 = Not infected, 3 = Indeterminate, 9 = Not documented U=Unknown
Description of changes above
Status changed to serostatus
Sib 1-Sib 6 was removed.
This question added an unknown option.
19. Was substance use during pregnancy noted in the medical or social work records?
Yes No (Go to Q23)
Record Not Available (Go to Q23)
Changed to:
19. Was substance use during pregnancy noted in the medical or social work records?
Yes No (Go to 20.) Record not available (Go to 20.)
Unknown
Description of changes above: This question added an unknown option.
19a. If yes, indicate which substances were used during pregnancy: (Mark all that apply)
Alcohol
Hallucinogens
Methamphetamines
Amphetamines
Heroin
Nicotine / Tobacco
Barbiturates
Marijuana (cannabis,
Opiates
Benzodiazepines
THC, cannabinoids)
Other, specify ______________________
Cocaine
Methadone
Not Documented which drug(s)
Crack Cocaine
Changed to:
19a. If yes, indicate which substances were used during pregnancy. (Check all that apply.)
Alcohol
Amphetamines
Barbiturates
Benzodiazepines
Cocaine
Crack cocaine
Hallucinogens
Heroin
Marijuana (cannabis, THC,
cannabinoids)
Methadone
Methamphetamines
Nicotine (any tobacco product)
Opiates
Other (Specify.)
_________________________
Specific drug(s) not documented
Description of changes above
(Mark all that apply)
Changed to
(Check all that apply.)
Nicotine / Tobacco
Changed to
Nicotine (any tobacco product)
Not Documented which drug(s)
Changed to
Specific drug(s) not documented
19b. If any substances used, were any of the drugs injected?
Yes
No
Not Documented
Specify which substance(s) were injected: ____________________________________________
Changed to:
19b. If substances used, were any injected?
Yes No Not documented
Unknown Specify injected substance(s).
Description of changes above:
19b. If any substances used, were any of the drugs injected?
Changed to
19b. If substances used, were any injected?
Specify which substance(s) were injected: ____________________________________________
Changed to
Specify injected substance(s).
20. Was a toxicology screen done on the mother during pregnancy or at delivery?
Yes, positive, please specify (Check all that apply):
Alcohol
Hallucinogens
Methamphetamines
Amphetamines
Heroin
Nicotine / Tobacco
Barbiturates
Marijuana (cannabis,
Opiates
Benzodiazepines
THC, cannabinoids)
Other, specify ______________________
Cocaine
Methadone
Not Documented which drug(s)
Yes, negative
No
Not Documented
Changed to:
20. Was a toxicology screen done on the mother (either during pregnancy or at the time of delivery)?
Yes, positive result (Check all that apply.)
Alcohol
Amphetamines
Barbiturates
Benzodiazepines
Yes, negative result
Cocaine
Crack cocaine
Hallucinogens
Heroin
No
Description of changes above:
Nicotine / Tobacco
Changed to
Nicotine (any tobacco product)
Not Documented which drug(s)
Changed to
Marijuana (cannabis, THC,
cannabinoids)
Methadone
Methamphetamines
Nicotine (any tobacco product)
Toxicology screen not documented
Opiates
Other (Specify.)
_______________________
Specific drug(s) not
documented
Specific drug(s) not documented
Crack cocaine was added to be similar to the other drug questions
21. Was a toxicology screen done on the infant at birth?
Yes, positive, please specify (Check all that apply):
Alcohol
Hallucinogens
Amphetamines
Heroin
Barbiturates
Marijuana (cannabis,
Benzodiazepines
THC, cannabinoids)
Cocaine
Methadone
Methamphetamines
Nicotine / Tobacco
Opiates
Other, specify ______________________
Not Documented which drug(s)
Yes, negative
No
Not Documented
Changed to:
21. Was a toxicology screen done on the infant at birth?
Yes, positive result (Check all that apply.)
Alcohol
Amphetamines
Barbiturates
Benzodiazepines
Yes, negative result
Cocaine
Crack cocaine
Hallucinogens
Heroin
No
Marijuana (cannabis, THC,
cannabinoids)
Methadone
Methamphetamines
Nicotine (any tobacco product)
Toxicology screen not documented
Description of changes above:
Yes, positive, please specify (Check all that apply):
Changed to
Yes, positive result (Check all that apply.)
Yes, negative
Changed to
Yes, negative result
Not Documented
Changed to
Toxicology screen not documented
Nicotine / Tobacco
Changed to
Nicotine (any tobacco product)
Not Documented which drug(s)
Changed to
Specific drug(s) not documented
Opiates
Other (Specify.)
_________________________
Specific drug(s) not
documented
Crack cocaine was added to be similar to the other drug questions
22. If indication of substance use, was the mother referred for treatment during or after this pregnancy?
Yes No
Not Documented
Changed to:
22. If the results of the toxocology screen indicated substance use, was the mother referred for treatment
(during or after this pregnancy)?
Yes No Not documented Unknown
Description of changes above:
22. If indication of substance use, was the mother referred for treatment during or after this pregnancy?
Changed to
22. If the results of the toxocology screen indicated substance use, was the mother referred for treatment (during or
after this pregnancy)?
This question added an unknown option.
23. The mother was diagnosed as being HIV positive: (HARS)
(Mother refused HIV testing)
Before child's birth, exact period unknown
Before this pregnancy
After the child's birth
During this pregnancy
HIV-infected, unk when diagnosed
At time of delivery
Changed to:
23. Mother’s HIV serostatus
Mother refused HIV testing
HIV-positive before child's birth, date unknown
HIV-positive before this pregnancy HIV-positive after child's birth
HIV-positive during this pregnancy HIV-positive, date unknown
HIV-positive at time of delivery
Description of changes above:
23. The mother was diagnosed as being HIV positive: (HARS)
Changed to
23. Mother’s HIV serostatus
(Mother refused HIV testing)
Changed to
Mother refused HIV testing
Before child's birth, exact period unknown
Changed to
HIV-positive before child's birth, date unknown
Before this pregnancy
Changed to
HIV-positive before this pregnancy
After the child's birth\
Changed to
HIV-positive after child's birth
During this pregnancy
Changed to
HIV-positive during this pregnancy
HIV-infected, unk when diagnosed
Changed to
HIV-positive, date unknown
At time of delivery
Changed to
HIV-positive at time of delivery
24. Date of mother's first positive confirmatory test (earliest known test): __ __/__ __/__ __ __ __ (HARS)
(Confirmatory test is Western Blot or IFA) (mm/dd/yyyy)
Changed to:
24. Date of mother's first positive result from confirmatory testing (WB or IFA)
__ __/__ __/__ __ __ __ (mm/dd/yyyy)
Description of changes above: Minor changes in wording
25. Mother’s HIV screening during pregnancy.
Results§
(see below)
25a. First Screening
___________________
Test *
(see below)
Date
(mm/dd/yyyy)
___________
__ __/__ __/__ __ __
__
25b. Second Screening (if negative or refused first screening)
___________________
___________
__ __/__ __/__ __ __
*Tests
__
Rapid
Expedited EIA
EIA
Not Documented
25c. Third Screening (if negative or refused second screening)
___________________
___________
__ __/__ __/__ __ __
__
*Tests
§ Results
Positive
Rapid
EIA
Negative
Not Documented
Indeterminate
Results not found
Changed to:
Not tested
25. Results of mother’s
screening
during
pregnancy
Not HIV
tested,
known to be
infected
Refused
Results
Test
Unknown
(See list in 26.)
(See list in 26.)
Date
(mm/dd/yyyy)
25a. First screening
___________________________________________
____________________ __ __/__ __/__ __ __ __
25b. Second screening (if result was negative, or mother refused first screening)
___________________________________________
____________________
__ __/__ __/__ __ __ __
25c. Third screening (if result was negative, or mother refused second screening)
___________________________________________
Results
Positive
Negative
Indeterminate
Results not available
Not tested
Not tested but known to be infected
Refused
Unknown
____________________
Tests
Rapid
Expedited EIA
EIA
Not documented
Description of changes above:
(if negative or refused first screening)
Changed to (if result was negative, or mother refused first screening)
Results not found to Results not available
Added Expedited EIA
__ __/__ __/__ __ __ __
Military time
noon
=
4:30 pm =
midnight =
12:30 am =
12:00
16:30
00:00
00:30
26. Mother’s HIV screening at time of labor and delivery.
ONTINUED –
Test *
Date Results at L&D Time† Results at
Results§
(see below)
(see below)
(mm/dd/yyyy)
L&D
(see below)
26a. First Screening
___________________
___________
__ __/__ __/__ __ __
__
__ __:__ __
26b. Second Screening (if applicable)
___________________
___________
26c. Confirmatory Test
___________________
§ Results
Positive
Negative
Indeterminate
Changed Results
to: not found
Not tested
Not tested, known to be infected
26. Mother’s
HIV screening at time of
Refused
Unknown
Results
___________
__ __/__ __/__ __ __
__
__ __:__ __
__ __/__ __/__ __ __
__
__ __:__ __
† Military time
noon = 12:00
4:30pm = 16:30
midnight = 00:00
12:30am = 00:30
*Tests
Rapid
Expedited EIA
EIA
Not Documented
labor and delivery
Test
(See list.)
Date of results in
labor and delivery
(mm/dd/yyyy)
Time of results in
labor and delivery
(See military time.)
____________________
__ __/__ __/__ __ __
__
__ __:__ __
____________________
__ __/__ __/__ __ __
__
__ __:__ __
___________________________________________
____________________
__ __/__ __/__ __ __
__
Results
Positive
Negative
Indeterminate
Results not available
Not tested
Not tested but known to be infected
Refused
Unknown
Tests
Rapid
Expedited EIA
EIA
Not documented
(See list.)
26a. First screening
___________________________________________
26b. Second screening (if applicable)
___________________________________________
26c. Confirmatory test
__ __:__ __
Military time
noon
= 12:00
4:30 pm = 16:30
Midnight = 00:00
12:30 am= 00:30
Description of changes above:
(see below)
Changed to
(See list.)
Date Results at L&D
(mm/dd/yyyy)
Changed to
Date of results in
labor and delivery
(mm/dd/yyyy)
Time† Results at L&D
(see below)
Changed to
Time of results in labor and delivery
(See military time.)
Results not found to Results not available
27. Were CD4 counts obtained during pregnancy?
Yes
No (Go to Q28)
Not Documented (Go to Q28)
Record Not Available (Go to Q28)
27a. If yes, list below (If more than three in record, prioritize those CD4 counts closest to delivery. If CD4
counts were not conducted during pregnancy, CD4 counts within 6 months before pregnancy would be
useful to record.)
Example: CD4 count 174, 12% would be coded as:
174
Count
08/12/2000
12
Percent
08/12/2000
CD4 Result
Units
Date blood drawn
(mm/dd/yyyy)
__ __ __ __
Count
__ __/__ __/__ __ __ __
__ __ __ __%
Percent
__ __/__ __/__ __ __ __
__ __ __ __
Count
__ __/__ __/__ __ __ __
__ __ __ __%
Percent
__ __/__ __/__ __ __ __
__ __ __ __
Count
__ __/__ __/__ __ __ __
__ __ __ __%
Percent
__ __/__ __/__ __ __ __
Changed to:
27. Were CD4 counts determined during pregnancy or within 6 months before pregnancy?
Yes No (Go to 28.) Not documented (Go to 28.) Record not available (Go to 28.)
Unknown
27a. If yes, list below. (If more than 3 counts in record, prioritize the CD4 counts, starting with the count closest to delivery. If CD4
counts were not determined during pregnancy, record CD4 counts within 6 months before pregnancy if possible.)
Example: CD4 count of 174 cells/µL, 12%, August 12, 2000, would
be recorded as
CD4
result
__ __ __
__
Unit
Date blood drawn
(mm/dd/yyyy)
cells/µ
L
__ __/__ __/__ __ __
__
__ __ __
__
%
__ __/__ __/__ __ __
__
__ __
__ __
CD4
result
174
cells/µL
08/12/2000
12
%
08/12/2000
Unit
Date blood drawn
(mm/dd/yyyy)
CD4
result
cells/µL
__ __/__ __/__ __ __
__
__ __ __
__
%
__ __/__ __/__ __ __
__
__ __
Unit
Date blood drawn
(mm/dd/yyyy)
cells/µL
__ __/__ __/__ __ __
__
%
__ __/__ __/__ __ __
__
Description of changes above:
27. Were CD4 counts obtained during pregnancy?
Changed to
27. Were CD4 counts determined during pregnancy or within 6 months before pregnancy?
(If more than three in record, prioritize those CD4 counts closest to delivery. If CD4 counts were not conducted
during pregnancy, CD4 counts within 6 months before pregnancy would be useful to record.)
Changed to
(If more than 3 counts in record, prioritize the CD4 counts, starting with the count closest to delivery. If CD4 counts wer
determined during pregnancy, record CD4 counts within 6 months before pregnancy if possible.)
Count
Changed to
cells/µL
Percent was removed; % was retained.
This question added an unknown option.
28. Did mother have viral quantification tests performed (i.e., viral load) during pregnancy?
Yes
No (Go to Q29)
Not Documented (Go to Q29)
Record Not Available (Go to Q29)
28a. If yes, list all results below (If more than three in record, prioritize those viral load tests closest to
delivery. If viral load tests were not conducted during pregnancy, viral loads within 6 months before
pregnancy would be useful to record.)
Result in
copies/mL #
Result in
logs
___________
__________
__ __/__ __/__ __ __ __
___________
__________
__ __/__ __/__ __ __ __
___________
__________
__ __/__ __/__ __ __ __
Date blood drawn
(mm/dd/yyyy)
Changed to:
28. Were viral quantification tests (ie, viral load) performed on the mother during pregnancy or within 6 months before pregnancy?
Yes No (Go to 29.) Not documented (Go to 29.) Record not available (Go to 29.) Unknown
28a. If yes, list all results below. (If more than 3 in record, prioritize the results of viral load tests, starting with the result closest to
delivery. If viral load tests were not performed during pregnancy, record viral loads within 6 months of pregnancy if possible.)
Result in No. of copies/mL
Result in logs
Date blood drawn
(mm/dd/yyyy)
_________________________
_____________
__ __/__ __/__ __ __
__
_________________________
_____________
__ __/__ __/__ __ __
__
_________________________
_____________
__ __/__ __/__ __ __
__
Description of changes above:
28. Did mother have viral quantification tests performed (i.e., viral load) during pregnancy?
Changed to
28. Were viral quantification tests (ie, viral load) performed on the mother during pregnancy or within 6 months
before pregnancy?
(If more than three in record, prioritize those viral load tests closest to delivery. If viral load tests were not
conducted during pregnancy, viral loads within 6 months before pregnancy would be useful to record.)
Changed to
(If more than 3 in record, prioritize the results of viral load tests, starting with the result closest to delivery. If viral load t
performed during pregnancy, record viral loads within 6 months of pregnancy if possible.)
This question added an unknown option.
Result in copies/mL #
Changed to
Result in No. of copies/mL
29. What was mother's most advanced HIV classification during pregnancy:
HIV, not AIDS
AIDS, CD4 criteria only
AIDS, indicator condition
HIV negative
Not Doc
Changed to:
29. What was the mother's most advanced HIV serostatus during pregnancy?
HIV infection, not AIDS
AIDS, CD4 criteria only
AIDS, indicator condition
HIV-negative
Not documented Record not available
Unknown
Description of changes above:
29. What was mother's most advanced HIV classification during pregnancy:
Changed to
29. What was mother's most advanced HIV classification during pregnancy:
HIV, not AIDS
Changed to
HIV infection, not AIDS
HIV negative
Changed to
HIV-negative
Not Doc
Changed to
Not documented
RNA
Changed to
Record not available
This question added an unknown option.
30. Was mother's HIV status noted in her prenatal care medical records?
Yes, Positive
Yes, Negative
No
No prenatal care
Record Not Available
Changed to:
30. Was the mother's HIV serostatus noted in her prenatal care medical records?
Yes, HIV-positive Yes, HIV-negative No No prenatal care Record not available
Unknown
Description of changes above:
Status
Changed to
serostatus
Yes, Positive
Changed to
Yes, HIV-positive
Yes, Negative
Changed to
Yes, HIV-negative
This question added an unknown option.
31. Was mother prescribed any antiretroviral medication during this pregnancy? (HARS)
Yes (Complete Table)
No (Go to Q31A)
Not Documented (Go to Q32)
RNA (Go to Q32)
Drug Name
(Use drug list)
Was
Drug
Refused
Date Drug Started
(mm/dd/yy)
Gestational
Age Started
(weeks,
round down)
Drug Stopped
Date Stopped
(mm/dd/yy)
Drug
Stop
Codes
Yes No ND
i. ______________
Yes
__ __/__ __/__ __
____
If yes, __ __/__ __/__ __ ____
ii. ______________
Yes
__ __/__ __/__ __
____
If yes, __ __/__ __/__ __ ____
iii. ______________
Yes
__ __/__ __/__ __
____
If yes, __ __/__ __/__ __ ____
iv. ______________
Yes
__ __/__ __/__ __
____
If yes, __ __/__ __/__ __ ____
v. ______________
Yes
__ __/__ __/__ __
____
If yes, __ __/__ __/__ __ ____
vi. ______________
Yes
__ __/__ __/__ __
____
If yes, __ __/__ __/__ __ ____
vii. ______________
Yes __ __/__ __/__ __
(After completing table, Go to Q32)
Changed to:
____
If yes, __ __/__ __/__ __ ____
31. Were antiretroviral drugs prescribed for the mother during this pregnancy?
Yes (Complete table.)
No (Go to 31a.)
Not documented (Go to 32.)
Record not available (Go to 32.) Unknown
Date stopped
(if yes in preceding column)
(mm/dd/yyyy)
Stop codes
(See list on
p. 8.)
__ __/__ __/__ __ __ __
________
_____________
__ __/__ __/__ __ __ __
________
__ __/__ __/__ __ __ __
_____________
__ __/__ __/__ __ __ __
________
__ __/__ __/__ __ __ __
_____________
__ __/__ __/__ __ __ __
________
__________
__ __/__ __/__ __ __ __
_____________
__ __/__ __/__ __ __ __
________
__________
__ __/__ __/__ __ __ __
_____________
__ __/__ __/__ __ __ __
________
vii.________________ __________
__ __/__ __/__ __ __ __
_____________
__ __/__ __/__ __ __ __
________
viii._______________ __________
__ __/__ __/__ __ __ __
_____________
__ __/__ __/__ __ __ __
________
Drug name
(See list on p. 8.)
Other
(specify)
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
(After completing table, go to 32.)
Description of changes above:
31. Was mother prescribed any antiretroviral medication during this pregnancy? (HARS)
Changed to
31. Were antiretroviral drugs prescribed for the mother during this pregnancy?
RNA (Go to Q32)
Changed to
Record not available (Go to 32.)
Other (specify) was added to drug name
Was Drug Refused
Changed to
Drug refused
Gestational Age Started
(weeks, round down)
Changed to
Gestational age drug started
(weeks; round down)
If yes, __ __/__ __/__ __
Changed to
__ __/__ __/__ __ __ __
Drug Stop Codes
Changed to
Stop codes
(See list on p. 8.)
This question added an unknown option.
31a. If no ARV was prescribed during pregnancy, indicate reason:
No prenatal care
Mother refused
HIV status of mother unknown
Other reason, specify __________________
Mother known to be HIV negative during pregnancy Not Documented
Changed to:
31a. 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.)
Description of changes above:
31a. If no ARV was prescribed during pregnancy, indicate reason:
Changed to
31a. If no antiretroviral drug was prescribed during pregnancy, check reason.
Other reason, specify __________________
Changed to
Other (Specify.)
This question added an unknown option.
32. Was mother's HIV status noted in her labor/delivery medical records?
Yes, Positive
Yes, Negative
No
Record Not Available
Changed to:
32. Was mother's HIV serostatus noted in her labor and delivery records?
Yes, HIV-positive Yes, HIV-negative
No Record not available Unknown
Description of changes above :
Status
Changed to
serostatus
Yes, Positive
Changed to
Yes, HIV-positive
Yes, Negative
Changed to
Yes, HIV-negative
This question added an unknown option.
33. Did mother receive antiretroviral medication during labor and delivery? (HARS)
Yes (Complete Table)
No (Go to Q33A)
Not Documented (Go to Q34)
Drug Name
(Use drug list)
Was
Drug
Refused
Date Received
(mm/dd/yy)
Time†
Received
(see below)
i. ___________________
Yes
__ __/__ __/__ __
__ __:__ __
ii. ___________________
Yes
__ __/__ __/__ __
__ __:__ __
iii. ___________________
Yes
__ __/__ __/__ __
__ __:__ __
iv. ___________________
Yes
__ __/__ __/__ __
__ __:__ __
v. ___________________
Yes
__ __/__ __/__ __
__ __:__ __
vi. ___________________
Yes
__ __/__ __/__ __
__ __:__ __
vii. __________________
Yes
__ __/__ __/__ __
__ __:__ __
(After completing table, Go to question 34)
†
RNA (Go to Q34)
Type of Administration
Oral
IV
Rcvd, route not doc
military time: noon = 12:00 midnight = 00:00
Changed to:
33. Did mother receive antiretroviral drugs during labor and delivery?
Yes (Complete table.)
Drug Name
(See list.)
No (Go to 33a.)
Other
(specify)
Not documented (Go to 34.)
Drug
refused
Record not available
(Go to 34.)
Date received
(mm/dd/yyyy)
Time received
(See military time.)
Oral
Unknown
Type of administration
IV
Not documented
i. ___________________
____________
__ __/__ __/__ __ __ __
__ __:__ __
ii. __________________
____________
__ __/__ __/__ __ __ __
__ __:__ __
iii. __________________
____________
__ __/__ __/__ __ __ __
__ __:__ __
iv. __________________
____________
__ __/__ __/__ __ __ __
__ __:__ __
v. __________________
____________
__ __/__ __/__ __ __ __
__ __:__ __
vi. __________________
____________
__ __/__ __/__ __ __ __
__ __:__ __
vii. __________________
____________
__ __/__ __/__ __ __ __
__ __:__ __
(After completing table, go to 34.)
Military time: noon = 12:00; midnight = 00:00
Description of changes above:
31. Was mother prescribed any antiretroviral medication during labor and delivery? (HARS)
Changed to
31. Were antiretroviral drugs prescribed for the mother during labor and delivery?
RNA (Go to Q32)
Changed to
Record not available (Go to 32.)
Other (specify) was added to drug name
Was Drug Refused
Changed to
Drug refused
This question added an unknown option.
33a. If no ARV was received during labor & delivery, indicate reason:
Precipitous delivery/STAT c-section
Mother tested HIV negative during pregnancy
Prescribed but not administered
Mother refused
HIV status of mother unknown
Other reason, specify____________________
Birth outside of hospital
Not Documented
Changed to:
33a. If no antiretroviral drug was received during labor and delivery, check reason.
Precipitous delivery/STAT
Cesarean delivery
HIV serostatus of mother
unknown
Mother tested HIV-negative Other (Specify.)
during pregnancy
_______________________
Prescribed but not administered
Birth not in hospital
Mother refused
Not documented
Unknown
Description of changes above:
33a. If no ARV was received during labor & delivery, indicate reason:
Changed to
33a. If no antiretroviral drug was received during labor and delivery, check reason.
Status
Changed to
Serostatus
Birth outside of hospital
Changed to
Birth not in hospital
This question added an unknown option.
34. Was mother referred for HIV care after delivery?
Yes
No (Go to Q36)
Not Documented (Go to Q36)
Changed to:
34. Was mother referred for HIV care after delivery?
Yes
No (Go to 36.)
Not documented (Go to 36.)
Unknown
Record Not Available (Go to Q36)
Record not available (Go to 36.)
Description of changes above: This question added an unknown option.
35. If yes, indicate first viral load and/or CD4 after discharge from hospital up to 6 months:
35a. CD4:
Not Done
Not Available
35b. Viral Load:
Not Done
Not Available
CD4 Result
Units
Date blood drawn
(mm/dd/yyyy)
__ __ __ __
Count
__ __/__ __/__ __ __ __
__ __ __ __%
Percent
__ __/__ __/__ __ __ __
Result in
copies/mL #
Result in
logs
__________
_________
Date blood drawn
(mm/dd/yyyy)
__ __/__ __/__ __ __ __
Changed to:
35. If yes, indicate first CD4 result or first viral load after discharge from hospital (up to 6 months after discharge).
35a. CD4 result
Not done Not available
35b. Viral load
Not done Not available
Result
Unit
Date blood drawn
(mm/dd/yyyy)
Result in copies/mL
Result in logs
__ __ __ __
cells/µL
__ __/__ __/__ __ __ __
_________________
____________
%
__ __/__ __/__ __ __ __
__ __
Date blood drawn
(mm/dd/yyyy)
__ __/__ __/__ __ __ __
Description of changes above:
35. If yes, indicate first viral load and/or CD4 after discharge from hospital up to 6 months:
Changed to
35. If yes, indicate first CD4 result or first viral load after discharge from hospital (up to 6 months after discharge).
35a. CD4:
Changed to
35a. CD4 result
CD4 Result
Changed to
Result
Units
Change to
Unit
Result in copies/mL #
Changed to
Result in copies/mL
36. Type of birth: (HARS)
Single
Twin
Changed to:
36. Type of birth Single
Triplet or greater
Twin
>3
Record Not Available
Record not available Unknown
Description of changes above:
Triplet or greater
Changed to
>3
This question added an unknown option.
Time*
Date
(mm/dd/yyyy)
37. Birth information:
Birth Outside Hospital
Record Not Available
Onset of labor
__ __:__ __
__ __/__ __/__ __ __ __
Admission to L/D
__ __:__ __
__ __/__ __/__ __ __ __
Rupture of Membranes
__ __:__ __
__ __/__ __/__ __ __ __
Delivery
__ __:__ __
__ __/__ __/__ __ __ __
*military time: noon=12:00 midnight=00:00
Changed to:
37. Birth information
Birth not in hospital
Time
Record not available
Date (mm/dd/yyyy)
(See military time.)
Onset of labor
Admission to labor and delivery
__ __:__ __
__ __:__ __
(See military time.)
__ __/__ __/__ __ __ __
__ __/__ __/__ __ __ __
Rupture of membranes
Delivery
Military time: noon = 12:00; midnight = 00:00
Description of changes above:
Birth Outside Hospital
Changed to
Birth not in hospital
39. Mode of Delivery: (HARS)
Vaginal (Go to Q40)
Elective C-section
Non-elective C-section
C-section, unknown type
Record Not Available (Go to Q41)
Changed to:
39. Mode of delivery
Vaginal (Go to 40.) Unknown
Elective Cesarean delivery
Non-elective Cesarean delivery
Cesarean delivery, unknown type
Record not available (Go to 41.)
Description of changes above:
C-section
Changed to
Cesarean delivery
This question added an unknown option
39a. If C-section delivery, mark all the following indications for C-section that apply:
HIV indication (high viral load)
Fetal distress
Previous C-section(repeat)
Placenta abruptia / previa
Malpresentation (breech, transverse lie)
Other (Herpes, disproportion, etc)
Prolonged labor / failure to progress
specify _____________________
Personal / Physician’s Preference
Not specified
Changed to:
39a. If Cesarean delivery, mark all the following indications that apply.
HIV indication (high viral load)
Previous Cesarean (repeat)
Malpresentation (breech, transverse)
Prolonged labor or failure to progress
Description of changes above:
C-section
Changed to
Cesarean delivery
Fetal distress
Placenta abruptia or p. previa
Other (eg, herpes, disproportion)
Specify ________________________________
Mother’s or physician’s preference
Not specified
transverse lie
Changed to
transverse
Personal / Physician’s Preference
Changed to
Mother’s or physician’s preference
40. Instrumentation used:
None
Forceps
Vacuum
Forceps and vacuum
Not specified
Changed to:
40. Instrument used None
Forceps
Vacuum
Forceps and vacuum
Description of changes above:
40. Instrumentation used:
Changed to
40. Instrument used
42. Was mother's HIV status noted on the exposed child's birth record?
Yes, Positive
Yes, Negative
No
Record Not Available
Changed to:
42. Was mother's HIV serostatus noted on the child's birth record?
No
Yes, HIV-positive Yes, HIV-negative Record not available Unknown
Description of changes above
Status
Changed to
serostatus
Not specified
Yes, Positive
Changed to
Yes, HIV-positive
Yes, Negative
Changed to
Yes, HIV-negative
This question added an unknown option.
43. Was child prescribed any antiretroviral medication during the first six weeks of life? (HARS)
Yes (Complete Table)
No (Go to Q43A)
Not Documented (Go to Q44)
RNA (Go to Q44)
Drug Name
(Use drug list)
Date Drug Started
(mm/dd/yy)
Was Drug
Refused
Regimen
Completed
Time† Started
(see below)
Stop Date
(mm/dd/yy)
Yes No ND
Drug
Stop
Codes
i. ______________
Yes
__ __/__ __/__ __
__ __:__ __
If no, __ __/__ __/__ __
____
ii. ______________
Yes
__ __/__ __/__ __
__ __:__ __
If no, __ __/__ __/__ __
____
iii. ______________
Yes
__ __/__ __/__ __
__ __:__ __
If no, __ __/__ __/__ __
____
iv. ______________
Yes
__ __/__ __/__ __
__ __:__ __
If no, __ __/__ __/__ __
____
v. ______________
Yes
__ __/__ __/__ __
__ __:__ __
If no, __ __/__ __/__ __
____
vi. ______________
Yes
__ __/__ __/__ __
__ __:__ __
If no, __ __/__ __/__ __
____
vii. ______________
Yes
__ __/__ __/__ __
__ __:__ __
If no, __ __/__ __/__ __
____
†
military time: noon = 12:00 midnight = 00:00
Changed to:
43. Were antiretroviral drugs prescribed for the child during the first 6 weeks of life?
Yes (Complete table.) No (Go to 43a.) Not documented (Go to 44.) Record not available (Go to 44.) Unknown
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.________________ ____________
__ __/__ __/__ __ __ __
__ __:__ __
__ __/__ __/__ __ __ __
_______
vii.________________ ____________
__ __/__ __/__ __ __ __
__ __:__ __
__ __/__ __/__ __ __ __
_______
Drug name
(See list on p. 8.)
Other
(specify)
viii._______________ ____________
__ __/__ __/__ __ __ __
__ __:__ __
__ __/__ __/__ __ __ __
_______
Military time: noon = 12:00; midnight = 00:00
Description of changes above:
43. Was child prescribed any antiretroviral medication during the first six weeks of life? (HARS)
Changed to
43. Were antiretroviral drugs prescribed for the child during the first 6 weeks of life?
RNA (Go to Q32)
Changed to
Record not available (Go to 32.)
Other (specify) was added to drug name
Was Drug Refused
Changed to
Drug refused
Regimen Completed
Yes No ND
Changed to
ART Completed?
Yes No ND UNK
If no, __ __/__ __/__ __
Changed to
__ __/__ __/__ __ __ __
Drug Stop Codes
Changed to
Stop codes
(See list on p. 8.)
This question added an unknown option.
43a. If no ARV was prescribed during the first six weeks of life, indicate reason:
HIV status of mother unknown
Other reason, specify __________________
Mother known to be HIV negative during pregnancy Not Documented
Mother refused
Changed to:
43a. If no antiretroviral drug was prescribed during the first 6 weeks of life, indicate reason.
HIV serostatus of mother unknown
Other (Specify.) _____________________________
Mother known to be HIV-negative during pregnancy _________________________ Not documented
Mother refused
Description of changes above:
43a. If no ARV was prescribed during the first six weeks of life, indicate reason:
Changed to:
43a. If no antiretroviral drug was prescribed during the first 6 weeks of life, indicate reason.
Status
Changed to
Serostatus
44. Infant’s HIV antibody testing.
Results§
(see below)
Test *
(see below)
Date Blood Drawn
(mm/dd/yyyy)
i. ___________________ ___________ __ __/__ __/__ __ __ __
ii. ___________________ ___________ __ __/__ __/__ __ __ __
iii. ___________________ ___________ __ __/__ __/__ __ __ __
Changed to:
§ Results
Positive
Negative
Indeterminate
Results not found
Not tested
Refused
Unknown
*Tests
Rapid
Expedited EIA
EIA
Not Documented
44. Infant’s HIV antibody testing
Results
(See list.)
i. ________________
ii. _______________
iii. _______________
Results
Positive
Negative
Indeterminate
Results not available
Infant not tested
Mother refused
Unknown
Test
(See list.)
______________
______________
______________
Tests
Rapid
Expedited EIA
EIA
Not documented
Description of changes above:
Results not found
Changed to
Results not available
Same for Q45
46. What is the child's current HIV status? (HARS-modified)
AIDS
Date blood drawn
(mm/dd/yyyy)
__ __/__ __/__ __ __ __
__ __/__ __/__ __ __ __
__ __/__ __/__ __ __ __
Confirmed HIV infected (not AIDS)
HIV negative
Indeterminate as of __ __/__ __/__ __ __ __ (mm/dd/yyyy)
Changed to:
46. What is the child's current HIV infection status?
AIDS
Confirmed HIV infected (not AIDS)
HIV-negative Indeterminate as of
__ __/__ __/__ __ __ __ (mm/dd/yyyy)
Description of changes above :
HIV status? (HARS-modified)
Changed to
HIV infection status?
47. If child's HIV status is indeterminate, indicate why: (HARS-modified)
Moved from state
Lost to Follow-up
Child less than 18 months of age
Provider out of state
Died before status determined
Not Documented
Changed to:
47. If child's HIV serostatus is indeterminate, indicate reason.
Moved from state Lost to follow-up
Provider out of state Died before serostatus determined
Child <18 months of age Not documented
Description of changes above:
47. If child's HIV status is indeterminate, indicate why: (HARS-modified)
Changed to:
47. If child's HIV serostatus is indeterminate, indicate reason.
Status
Changed to
serostatus
48. Was PCP prophylaxis prescribed in the first year of life? (HARS)
Yes, date started __ __/__ __/__ __ __ __ No
Not Documented
Changed to:
48. Was PCP prophylaxis prescribed during the first year of life?
Yes Date received __ __/__ __/__ __ __ __
No Not documented
Record not available Unknown
Description of changes above:
Yes, date started
Changed to
Date received
Record Not Available
This question added an unknown option
49.Was child breastfed? (HARS)
Yes, duration ___ days ___ weeks ___not doc
No
Not Documented
Changed to:
49.Was child breastfed?
Yes Duration _ days ___ weeks
Duration not documented
No Not documented
Record not available Unknown
Record Not Available
Description of changes above:
not doc
Changed to
Duration not documented
This question added an unknown option
50. Were any birth defects noted in the first year of life? (HARS)
Yes
No (Go to Q51)
Record Not Available (Go to Q51)
50a. If yes, specify type(s): _______________________________________________________
Code: _____._____
Code: _____._____
Code: _____._____
Changed to:
50. Were birth defects noted during the first year of
life?
Yes No (Go to 51.) Record not
available (Go to 51.)
Unknown
50a. If yes, specify type(s). ______________________
Code _____._____
Code
_____._____
Code _____._____
Description of changes above: This question added an unknown option.
51. If child deceased, from death certificate, list (Please print legibly):
(Include ICD9 codes only if code appears on death certificate)
Immediate cause of death ________________________________________
ICD9
_______
Underlying cause of death ________________________________________
_______
Underlying cause of death ________________________________________
_______
Underlying cause of death ________________________________________
_______
Contributing cause of death _______________________________________
_______
NOTE: If the child has died and you are completing this portion of the abstraction form, please verify
that a date of death has been entered for the infant on page 1, Basic Demographics, Question 2.
Changed to:
51. If child is deceased, please obtain the following from the death certificate. (Print legibly. Include ICD-9 or
ICD-10 codes only if code appears on death certificate.)
Cause of death
Immediate __________________________________________________________
Underlying _________________________________________________________
Underlying _________________________________________________________
Underlying _________________________________________________________
Contributing ________________________________________________________
Note. Please be sure that a date of death has been entered on page 1, under Demographic Information (2.
Infant).
51. If child deceased, from death certificate, list (Please print legibly):
(Include ICD9 codes only if code appears on death certificate)
Changed to
51. If child is deceased, please obtain the following from the death certificate. (Print legibly. Include ICD-9 or ICD10 codes only if code appears on death certificate.)
NOTE: If the child has died and you are completing this portion of the abstraction form, please verify
that a date of death has been entered for the infant on page 1, Basic Demographics, Question 2.
Changed to
Note. Please be sure that a date of death has been entered on page 1, under Demographic Information (2. Infant).
Please include any comments or clinical information you feel is relevant to the overall understanding of this
child's HIV-exposure or infection status. Include where the information came from and the relevant date.
Changed to:
Please include comments or clinical information you consider relevant to the overall understanding of this child's
HIV exposure or infection status. State the date and source of the information.
Antiretroviral Drugs and Stop Codes
Antiretroviral Drug List
NNRTI
Delavirdine (Rescriptor)
Efavirenz (Sustiva)
Nevirapine (Viramune, NVP)
NRTI
Abacavir (Ziagen, ABC)
Combivir (AZT & 3TC)
Didanosine (ddI, Videx)
Lamivudine (3TC, Epivir)
Stavudine (d4T, Zerit)
Trizivir (AZT & 3TC & Abacavir)
Viread (Tenofovir)
PROTEASE INHIBITORS
Amprenavir (Agenerase)
Indinavir (Crixivan)
Kaletra (Lopinavir,
Ritonavir)
Nelfinavir (Viracept)
Ritonavir (Norvir)
OTHER
Adefovir dipivoxil (bis-POM,
PMEA, Preveon)
Atripla (Efavirenz & Tenofovir &
Emtricitabine)
If an antiretroviral drug
Zalcitabine (ddC, Hivid)
Zidovudine (AZT, Retrovir)
Stop Codes: [2 codes allowed-if more, pick the most important]
S1 = Adverse events (toxicity, lack of tolerance)
S2 = (Blank for EPS)
S3 = Drug resistance detected
S4 = Poor adherence
S5 = Inadequate effectiveness
S6 = Strategic treatment interruption (planned drug holiday)
S7 = Drug interactions
S8 = Patient choice
Saquinavir (Fortavase,
Invirase)
Tipranavir (Aptivus)
not on this list, call CDC
S9 = Pregnancy
S10 = Child determined to be HIV-uninfected
S11 = Improving effectiveness
S12 = Improving convenience
S13 = Reason not indicated, unknown
S14 = Mother couldn’t afford medications
Sxx = Other reason
Changed to:
Antiretroviral drugs and stop codes
NNRTI
Delavirdine (Rescriptor)
Efavirenz (Sustiva)
Nevirapine (Viramune, NVP)
NRTI
Abacavir (Ziagen, ABC)
Combivir (AZT & 3TC)
Didanosine (ddI, Videx)
Emtriva (Emtricitabine or FTC)
NRTI (cont)
Epzicom (Abacavir/3TC, Kivexa)
Lamivudine (3TC, Epivir)
Stavudine (d4T, Zerit)
Trizivir (AZT & 3TC & Abacavir)
Truvada (Tenofovir DF/Emtricitabine)
Videx® EC (Didanosine)
Viread (Tenofovir)
Zalcitabine (ddC, Hivid)
Zidovudine (AZT, Retrovir)
Protease inhibitor
Amprenavir (Agenerase)
Darunavir (Prezista)
Indinavir (Crixivan)
Kaletra (Lopinavir, Ritonavir)
Lexiva (Fosamprenavir)
Nelfinavir (Viracept)
Reyataz (Atazanavir or ATV)
Ritonavir (Norvir)
Saquinavir (Fortavase, Invirase)
Tipranavir (Aptivus)
Other
Adefovir dipivoxil (bis-POM,
PMEA, Preveon)
Atripla (Efavirenz & Tenofovir &
Emtricitabine)
Fuzeon (Enfuvirtide or T20)
Hydroxyurea (Droxia, Hydrea)
Intelence
Selzentry
Isentress
If an antiretroviral drug not on
this list, call CDC
Stop codes (2 codes allowed; if more, choose the 2 most important)
S1 = Adverse events (toxicity, lack of tolerance)
S2 = ART completed
S3 = Drug resistance detected
S4 = Poor adherence
S5 = Inadequate effectiveness
S6 = Strategic treatment interruption (planned drug holiday)
S7 = Drug interactions
S8 = Mother’s choice
S9 = Pregnancy
S10 = Child determined not to be HIV infected
Description of changes above:
S2 = (Blank for EPS)
Changed to
S2 = ART completed
S8 = Patient choice
Changed to
S8 = Mother’s choice
S14 = Mother couldn’t afford medications
Changed to
S14 = Mother couldn’t afford drugs
The following drugs were added to the drug list:
S11 = Improving effectiveness
S12 = Improving convenience
S13 = Reason not indicated; unknown
S14 = Mother couldn’t afford drugs
Sxx = Other reason
Emtriva (Emtricitabine or FTC);Epzicom (Abacavir/3TC, Kivexa);Truvada (Tenofovir DF/Emtricitabine) ;Videx®
EC (Didanosine) ;Darunavir (Prezista) ;Reyataz (Atazanavir or ATV);Fuzeon (Enfuvirtide or
T20);Hydroxyurea;(Droxia, Hydrea);Intelence;Selzentry; Isentress
Enhanced HIV/AIDS Surveillance to Maximally Reduce
Perinatal HIV Transmission
Instructions for Completing the Data Abstraction Form
General Comments
The purpose of this document is to provide guidance for filling out the data abstraction form, to define
medical terms, and to suggest the best places in the medical records to find specific pieces of information.
Information on children who are perinatally-HIV exposed or who have HIV/AIDS are collected under a
federal assurance of confidentiality. Information on HIV-exposed children must be collected on both the
HARS case report form and on the Enhanced Perinatal Surveillance Supplemental Data Abstraction Form
(referred to as the Enhanced Surveillance Form or EPS Form). All information that is collected using the
enhanced surveillance abstraction form should be promptly included/updated in the HARS software.
HARS is the gold standard for this project. Where data differs between the enhanced surveillance data
abstraction form and HARS, the HARS data will be used. The Enhanced Perinatal Surveillance System
(EPSS) and HARS/Ehars should be updated with information collected during abstraction. The HIV/AIDS
pediatric case reporting form and software were updated in 1995, then in 1996 with the Ryan White CARE
Act, and again in 2000 to allow for evaluation of the implementation and impact of the Public Health
Service recommendations on the prevention of perinatal HIV transmission, to accommodate surveillance
requirements of the Ryan White CARE Act Amendment signed into law on May 20, 1996, and to
accommodate the revised 2000 HIV case definition for perinatal HIV exposure, pediatric infection, and
those perinatally exposed but not infected with HIV. The Enhanced Perinatal Surveillance Data
Abstraction Form collects additional standardized data related to prevention of perinatal transmission
beyond those in the HARS system. These data taken together will assist in monitoring the implementation
of the new pediatric case definition and impact of the PHS recommendations (counseling and voluntary
testing of pregnant women and use of Zidovudine (ZDV) to prevent perinatal transmission) on pediatric
HIV/AIDS trends, responding to selected requirements of the Ryan White Care Act, and evaluating of
perinatal prevention efforts.
Be sure to 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, etc
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 was not an error having to do with the
abstraction, notation or data entry of the information.
The Enhanced Perinatal Surveillance Coordinator in each project area, or their designee, should
review all data abstraction forms before the data is 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.
08/29/06
Page 1 of 27
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
Maternal prenatal records
Maternal labor and delivery records
Maternal HIV clinic records
Infant
Pediatric birth records (hospital records)
Birth certificate
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 WHO 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.’
In other words, 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 HARS and supplemental
EPS 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 HARS 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 (Q.43 – Q.51). The updated infant’s HIV diagnostic tests, CD4
counts, and viral load test results should be entered directly into HARS.
Indicating ‘Unknown’
08/29/06
Page 2 of 27
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 marked 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.
If Conflicting Information is Found
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 ZDV, 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
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
‘magic’ marker.
Required Fields
There are three fields which are required on the abstraction form: Initials of the Abstractor filling the form,
Infant reporting state, Infant state number and Infant date of birth. Initials of the Abstractor filling the
form and infant state number are required fields in the EPSS application. These fields are necessary
for linkage to HARS data and as a quality control tool to ensure duplicate records are not entered into the
database.
Text boxes
Enter comments, specifics, or additional information (missing values can be left blank or entered
using two periods [..]).
08/29/06
Page 3 of 27
This introductory first section would include all identifying information (not sent to CDC) as well as
information on the abstractor, whether the information was complete and if it is a new form or an
updated form, information on how the infant was identified and what types of records
were abstracted.
NEW FORM/UPDATED FORM: Indicate by marking the appropriate box if the data abstraction form is a
new case abstraction or update of information for a previously abstracted case.
INITIALS OF ABSTRACTOR: This is a required field. Abstractors should legibly print their initials. If
more than one person abstracts records for a single data form, the initials of all abstractors should be
noted. These initials allow for follow-up with the abstractor for clarification and resolution of questions that
may come up.
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 EPS
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.
DATE FORM COMPLETED: This should be the date that the data abstraction form is completed (e.g. all
medical records have been abstracted or two attempts have been made to abstract) and record
abstraction is concluded. Updates to the abstraction form and to HARS are always possible at any time.
DATE FORM RECEIVED BY MAIN FACILITY: This should be the date that the data abstraction form is
received by the main facility or health department. If a site has external partners completing data
abstractions, the date of receipt by the main facility (EPS Coordinator) should be included.
DATE CASE WAS REPORTED: This should be the date the case was initially reported or identified as
an exposure to the health department, whether through routine case reporting or birth registry match. The
date of report should be linked to the method in which the infant was first identified.
HOW INFANT FIRST IDENTIFIED: Please check the first method through which the infant was identified
(e.g. an infant might have been identified through the maternal HARS record, and later been identified
through the registry match. This should be coded as ‘maternal report’). ‘Maternal report’ means that an
infant was identified because the mother’s case report indicated that she was pregnant at the time of
diagnosis or that she delivered a live-born infant after 1977. Additionally, a child’s birth information may
be included on the mother’s case report or there may be a notation in the comment section of the form that
08/29/06
Page 4 of 27
indicates an HIV-exposed child was born. ‘Pediatric report’ means an HIV-exposed child was first
identified through the child's case report.
IF MATERNAL INFORMATION IS NOT AVAILABLE, WAS THE CHILD ADOPTED, IN FOSTER CARE,
OR ABANODONED: Only complete check ‘Yes’ 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: 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.
I. Basic Demographics
Questions 2-8
This section details the basic demographics of the infant and mother, including reporting state,
statenos, citynos, soundex, dates of birth and death, sex of the infant, mother’s race/ethnicity,
mother’s marital status and mother’s HIV transmission category.
REPORTING STATE (mother and infant): The infant’s reporting state is a required field.
STATE NO./CITY NO.(mother and infant): The infant’s stateno is a required field. A HARS record will
be entered for each mother and infant investigated as part of Enhanced Perinatal Surveillance if
permissible under state reporting laws. The HARS State No. (and possibly City No.) generated for each
case should be entered here. For sites without HIV exposure reporting, a project ID number should be
created. A unique number should be assigned for each person, regardless of diagnostic status at first
report or changing status throughout the course of disease. These numbers will be used to communicate
with project areas regarding specific case reports and to link HARS records with the enhanced perinatal
data collected. State patient numbers should never be reused.
SOUNDEX (mother and infant): Enter the soundex code for the mother and the infant unless legally
prohibited from doing so. The soundex code can be generated from the patient’s last name using the
HARS software. Soundex should be entered in the EPSS application (will not be automatically generated
by the system). The soundex should be the same as generated by HARS.
DATE OF BIRTH (mother and infant): The infant’s date of birth is a required field. If all or part of the
mother’s date of birth is unknown, ‘ ’ (blank) should be coded in appropriate field (e.g. 02/../56).
DATE OF DEATH (mother and infant): If the mother and/or infant have died, enter their date of death. If
the infant dies after the initial report is submitted, date of death must be updated in HARS.
SEX AT BIRTH (infant): M=Male, F=Female
Q. 4
COUNTRY OF BIRTH: Write out the country of the mother’s birth. The data management
system will code when the country is entered into the system. EPSS has a dropdown menu to
select the country. If specific name of US Dependency is not known, a selection on the dropdown
menu which indicates “US Dependency” can be checked.
Q. 4a
If the mother’s country of birth is unknown, but her continent of birth is known, enter the
continent name in the space provided. The Continents are: Africa, Asia, North America, South
America, Europe, and Antarctica. (Australia is the seventh continent, but this will be captured
under country of birth so there is no need to indicate this as a continent of birth.)
Q. 5
HISPANIC ETHNICITY (mother): Indicate whether or not the mother is of Hispanic ethnicity
(Yes, No, Unknown).
08/29/06
Page 5 of 27
Q. 6
RACE (mother): More than one race can be selected. The five minimum race categories are
American Indian/Alaska Native, Asian, Black/African American, Hawaiian/Pacific Islander, White,
and Other.
The minimum categories for data on race and ethnicity for Federal statistics, program
administrative reporting, and civil rights compliance reporting are defined as follows:
•
•
•
•
•
•
American Indian or Alaska Native. A person having origins in any of the original peoples
of North and South America (including Central America), and who maintains tribal
affiliation or community attachment.
Asian. A person having origins in any of the original peoples of the Far East, Southeast
Asia, or the Indian subcontinent including, for example, Cambodia, China, India, Japan,
Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam.
Black or African American. A person having origins in any of the black racial groups of
Africa. Terms such as "Haitian" or "Negro" can be used in addition to "Black or African
American."
Hispanic or Latino. A person of Cuban, Mexican, Puerto Rican, Cuban, South or Central
American, or other Spanish culture or origin, regardless of race. The term, "Spanish
origin," can be used in addition to "Hispanic or Latino."
Native Hawaiian or Other Pacific Islander. A person having origins in any of the original
peoples of Hawaii, Guam, Samoa, or other Pacific Islands.
White. A person having origins in any of the original peoples of Europe, the Middle East,
or North Africa.
Q. 7
MARITAL STATUS: Check only one. This refers to the mother’s marital status at the time of
delivery.
Q. 8
MOTHER’S HIV RISK: If a risk is found for a mother whose HARS record does not contain any
risk information, update HARS with the appropriate risk. If additional, or more specific, risk
information is found, update the HARS record but do not delete a risk already in the record (i.e. do
not delete an existing IDU risk if heterosexual risk is found through your medical record reviews,
add the heterosexual risk to HARS.) If an unusual transmission circumstance is suspected, notify
the State NIR Coordinator immediately.
After 1977, this child’s biologic mother: (Mark all categories that apply)
Intravenous drug user (IDU, injected nonprescription drugs)
Person with hemophilia
‘Coagulation disorder’ or ‘hemophilia’ refers only to a disorder of a clotting factor, which
are any of the circulating proteins named ‘Factor I’, ‘Factor II’, ’Factor III’, etc., through
‘Factor XII’. These disorders include Hemophilia A and Von Willebrands disease (Factor
VIII disorders) and Hemophilia B (a ‘Factor IX’ 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 risk would be
‘transfusion’. See comments for ‘transfusion’ below.
Heterosexual contact with
Intravenous drug user
Bisexual male
Person with hemophilia/coagulation disorder
See comments for ‘coagulation disorder’ above.
Transfusion recipient with documented HIV infection
This refers to someone whose partner has documented HIV infection and whose
HIV risk was receipt of a transfusion of blood cells (red cells, white cells, platelets)
or plasma.
Transplant recipient with documented HIV infection
This refers to someone whose partner has documented HIV infection and whose
08/29/06
Page 6 of 27
HIV risk was receipt of a transplanted organ or tissue.
Male with AIDS or documented HIV infection, risk not specified
This category should be checked if the heterosexual partner is known to be HIV
positive, and only if his specific risk for HIV is unknown.
Transfusion Recipient (other than clotting factor)
Refers to the recipient of a transfusion of blood cells (red cells, white cells, platelets) or
plasma.
Perinatal Exposure
Refers to the mother’s status. The mother herself was infected with HIV perinatally.
Unknown/Other documented risk
Discuss with NRR Coordinator within your state if the mother’s risk factor is unknown. If
‘Other’, then specify the documented risk.
II. Prenatal Care
Questions 9-18
This section on prenatal care provides information on whether the mother received prenatal care
during her pregnancy, dates of first and last prenatal care visits and number of visits, type of
prenatal care facility, prenatal care screenings and diagnoses of medical conditions, mother’s
reproductive history, and infant’s sibling(s) information.
Hierarchy of records for response gold standard: If conflicting information is found for any of the
prenatal care questions, refer to this list to determine which response to include unless abstractor is
positive of the correct response.
1. Prenatal Care
2. Labor and Delivery
3. Pediatric Birth
4. Birth Certificate
5. Pediatric non-HIV
6. Pediatric HIV
7. Health Department
Q. 9
DID MOTHER RECEIVE ANY PRENATAL CARE FOR THIS PREGNANCY: A prenatal care
visit is defined as a visit to a health care provider (including a physician, nurse practitioner,
midwife, nurse, or physician’s assistant) specifically for obstetrical/gynecological services prior to
delivery of the baby. A visit by a prenatal care provider to the woman’s home would be
considered a prenatal care visit if it is done in the context of providing prenatal care to the woman.
Sometimes the number of prenatal care visits is summarized on one sheet within the prenatal
chart which lists the prenatal lab(s) and ultrasounds done at each visit, including the lab results.
At time of delivery this information is tallied and a total number of prenatal care visits will be noted
on the labor and delivery intake sheet. If the prenatal care record contains a prenatal care flow
chart, there is usually a list of the dates of visits. Also, most birth certificates now list the number
of prenatal care visits as well. (Note: the birth certificate is a notoriously poor source of data
regarding prenatal care. Only use this information if no other prenatal care information is available
from medical records.) If you find conflicting numbers of visits between the medical records and
the birth certificate, use the number of visits found in the medical records.
The following do not constitute a prenatal care visit: a visit to the lab to have blood tests only; a
visit for the sole purpose of picking up prenatal vitamins or other medication refills; a visit solely for
an illness or other medical problem not related to pregnancy; an emergency room visit; a visit to
an infectious disease practitioner for care of the woman’s HIV disease, a visit solely with the WIC
counselor, nutritionist, social worker, pharmacist, business office personnel, office receptionist,
ultrasonographer, EKG technician, HIV counselor (unless there is also a consultation with a health
care provider); a visit to the home of the woman by someone who is not a prenatal care provider.
08/29/06
Page 7 of 27
If no prenatal care is received or it is unknown if prenatal care was received, skip to Q.15.
Q. 10
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,
etc. If the woman had been seen by more than one prenatal care provider, then we would like the
date of the visit to the first prenatal care provider seen. If this date is unknown, put ‘ / / ‘ (all
spaces should be left blank). If part of the date is unknown, ‘ ’ (blank) should be coded in
appropriate field (i.e., 02/ /2005).
Q. 11
MONTH OF PREGNANCY PRENATAL CARE BEGAN: Record the month of pregnancy (01 to
09) that the woman began prenatal care. Do not leave this question blank. Enter ‘09' if care
began in the ninth month or later. If month is not noted in the chart but the gestational age in
weeks when prenatal care began is available, record the weeks. Mark ‘ ’ (blank) if unknown what
month the first visit occurred.
Q. 12
DATE OF LAST PRENATAL CARE VISIT PRIOR TO DELIVERY: This is the last visit for
prenatal care prior to delivery of the baby. For definition of a prenatal care visit, see Q. 9 above.
Q. 13
NUMBER OF PRENATAL CARE VISITS: See comments for Q. 9. If the number of visits is
unknown enter ‘99’. If there is a range of visits reported, i.e., 10-13, enter the lower number of
visits.
Q. 14
IN WHAT TYPE OF FACILITY WAS PRENATAL CARE PRIMARILY DELIVERED: If multiple
sources of care were used, indicate the primary source of care (i.e., where the majority of visits
occurred). If ‘Other’ is checked, be sure to specify what the facility is, using generally agreed
upon terms. Do not use local terms, acronyms, or abbreviations.
•
OB/GYN clinic - A clinic that provides obstetrical and gynecologic related, pregnancy,
and preventive care to women.
•
Adult HIV specialty clinic - A clinic associated with an inpatient facility, for the treatment
of HIV/AIDS in adults.
•
HMO clinic - A free-standing clinic run by a Health Maintenance Organization that is
connected to an inpatient facility run by the same organization.
•
Private physician’s office (OB/GYN, midwife) - An office where a physician, midwife or
nurse practitioner provides obstetric and gynecologic related, pregnancy, and preventive
care to women.
•
Correctional facility - A facility that provides diagnosis and/or treatment of disease in a
prison, jail, or other correctional facility, clinic or infirmary.
•
ACTG site - The AIDS Clinical Trials Group (ACTG) is an organization that was formed to
conduct AIDS research that is funded by the federal government. Many universities and
teaching hospitals across the country have an ACTG site associated with them.
•
Other - A known facility that is not able to be categorized into one of the categories
above.
•
Not Documented - The type of facility is not documented in any of the source records.
Q. 15
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
08/29/06
Page 8 of 27
•
•
•
Q. 16
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
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. 16.
DURING THIS PREGNANCY OR AT THE TIME OF LABOR AND DELIVERY WAS THE
MOTHER DIAGNOSED WITH ANY OF THE FOLLOWING CONDITIONS: 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:
•
Bacterial vaginosis - Clinician diagnosis of bacterial vaginosis. Sometimes abbreviated
BV.
•
Chlamydia (Chlamydia trachomatis) - Record positive test for chlamydia (either a positive
culture, positive EIA, or detection of chlamydial antigen or nucleic acid).
Name of lab tests - Chlamydia cell culture (TRIC Agent Culture); direct
fluorescent antibody (DFA) tests; enzyme immunoassay (EIA) tests; nucleic
hybridization (DNA probe) tests, 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
08/29/06
Page 9 of 27
•
•
•
•
•
08/29/06
(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), 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, ARTautomated 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.)
Page 10 of 27
Q. 17
MOTHER’S REPRODUCTIVE HISTORY: To specify ‘Not Documented’ use ‘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.
•
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 G5 P3 or it may be written as G5P3A1. 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.
G = gravida, the number of pregnancies including the current pregnancy
P = parity, the number of pregnancies > 20 weeks gestation (excludes miscarriages and 1st
trimester abortions)
A = Abortion, the number of abortions (both spontaneous and induced abortions)
For example, a woman who is G5 P3A1 has been pregnant 5 times (including the current
pregnancy), 3 of those pregnancies were carried to at least 20 weeks gestation, and she had 1
spontaneous or induced abortion.
Parity may also be documented as a four digit number. The first digit represents the number of
pregnancies delivered at full-term (at least 37 weeks gestation). The second digit represents the
number of pregnancies delivered pre-term (20-37 weeks). The third digit represents the number of
abortions including spontaneous or therapeutic abortions; and the last digit represents the number
of living children the woman currently has.
08/29/06
Page 11 of 27
P = parity may be documented as a 4 digit number
1st digit = term pregnancies (>37 weeks)
2nd digit = preterm pregnancies (20-37 weeks)
3rd digit = abortions (includes both spontaneous and induced abortions)
4th digit = living children
For example, a woman’s record may read G5 P2113. 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.17, remember that you will have to subtract
the current pregnancy from the gravida (G) notation.
This format is not always followed exactly as described here. When possible, it will be
useful to ask clinic nurses what their standard notation is.
Q. 18
COMPLETE THE CHART BELOW FOR ALL SIBLINGS: 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 HARS software
which allow only for the linking of one child with the mother’s HARS case report.
III. Substance Use
Questions 19-22
This section on substance abuse provides information on whether substance abuse occurred
during the mother’s pregnancy, types of substances used, and information on toxicology
screenings for the mother and infant.
Hierarchy of records for response gold standard (Q. 19, 20 & 22): If conflicting information is found for
any of these questions, refer to this list to determine which response to include unless abstractor is
positive of the correct response.
1. Prenatal Care
2. Maternal HIV Clinic
3. Labor and Delivery
4. Pediatric Birth
5. Pediatric non-HIV
6. Pediatric HIV
7. Health Department
Hierarchy of records for response gold standard (Q. 21): If conflicting information is found for this
question, refer to this list to determine which response to include unless abstractor is positive of the
correct response.
1. Pediatric Birth
2. Pediatric non-HIV
3. Pediatric HIV
4. Health Department
Q. 19
WAS SUBSTANCE USE DURING PREGNANCY NOTED IN THE MEDICAL OR SOCIAL
WORK RECORDS: 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 prenatal care visits, lab
results, gestational ages, etc.
Q. 19a IF YES, INDICATE WHICH SUBSTANCES WERE USED DURING THE PREGNANCY: The
drugs listed here are in alphabetical order. Heroin is a semisynthetic narcotic and opiate and
08/29/06
Page 12 of 27
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 indicate the name of the drug(s) used. If any drugs are used, be sure to complete Q. 19b.
Q. 19b IF ANY SUBSTANCES USED, WERE ANY OF THE DRUGS INJECTED: If any drug(s) used
were injected, mark ‘Yes’ and write the name of the drug in the space provided.
Q. 20
WAS A TOXICOLOGY SCREEN DONE ON THE MOTHER DURING PREGNANCY OR AT
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. If screening for ‘Other’ drug was done, be sure to indicate what the drug was in the
space provided.
Q. 21
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. Please specify all
drugs identified on screening, including methadone. If screening for ‘Other’ drug was done, be
sure to indicate what the drug was in the space provided.
Q. 22
WAS MOTHER REFERRED FOR SUBSTANCE ABUSE TREATMENT DURING OR AFTER
THIS PREGNANCY: This question asks about whether the mother was referred for substance
abuse treatment both during and after this pregnancy. This information is usually found in the
prenatal care records or in the hospital medical records in the physician, nurses, or social workers
notes.
IV. Mother’s HIV Testing
Questions 23-30
This section provides information on the mother’s HIV testing history and diagnosis of HIV. This
includes when the mother was diagnosed, results of HIV screening during pregnancy and
labor/delivery, dates of first and subsequent HIV tests, CD4 counts and viral loads during
pregnancy, and information on the most advanced serostatus of the mother during pregnancy.
Hierarchy of records for response gold standard: If conflicting information is found for any of the
mother’s HIV testing questions, refer to this list to determine which response to include unless abstractor
is positive of the correct response.
1. Maternal HIV Clinic
2. Prenatal Care
3. Labor and Delivery
4. Pediatric Birth
5. Pediatric non-HIV
6. Pediatric HIV
7. Health Department
Q. 23
THE MOTHER WAS DIAGNOSED AS BEING HIV POSITIVE: This question is asking for the
same information as on HARS even though the wording is different (HARS asks about the timing
of mother’s HIV diagnosis). Although we can determine this by comparing date of test and date of
infant’s birth, this field is included both to make analysis easier and to serve as a check.
•
Mother refused testing: only code ‘refused’ if refusal is documented in the maternal or
infant’s chart.
08/29/06
Page 13 of 27
•
•
•
•
•
•
Before this pregnancy: includes early pregnancy if subject was tested before pregnancy
was diagnosed.
During this pregnancy: any time after pregnancy was diagnosed.
At time of delivery: if tested when she was admitted for labor and delivery and ≤ 5 days
after delivery.
Before child’s birth: the mother was known to be HIV positive before child’s birth but the
exact timing of the positive test is unknown.
After child’s birth: if first test is conducted 6 or more days after the child’s birth (see
Delivery/postpartum category above).
HIV-infected, unknown when diagnosed: the mother was known to be HIV infected but
the timing of her diagnosis is unknown.
This question seeks to document the HIV status of the mother and, if HIV infected, the timing of
her HIV diagnosis relative to this child's birth. ‘Refused HIV testing’ should be checked if the
mother’s refusal is documented in the chart. If the biologic mother has been tested for HIV and
found to be uninfected at or after the child’s birth then perinatal transmission is not the presumed
mode of exposure to HIV infection. If mother-to-infant transmission through breastfeeding is
considered as the only mode of transmission, note that on the front page of the Enhanced
Surveillance Form and alert the state or local NIR Coordinator and CDC.
Q. 24
DATE OF MOTHER’S FIRST POSITIVE CONFIRMATORY TEST: (Western Blot or IFA) This
should be the day the blood was drawn (rather than the day the patient was counseled). If all or
part of date is unknown, ‘ ’ (blank) should be coded in appropriate field. If there is a physician
diagnosis that states, ‘HIV+ for 4 years’, for example, then code month and day as ‘XX’, and
subtract 4 from the year of the note in the chart to determine year of testing. If the mother has
only been tested once and it occurred during this pregnancy, the same date should be used for
this question as in Q.25a. Likewise, if the mother has only been tested once and it was at time of
labor and delivery, the date should be recorded in Q.26a.
Q. 25
MOTHER’S HIV SCREENING DURING PREGNANCY TABLE: Women who have already been
tested and reported may be retested in pregnancy.
•
Results - Enter the results of the rapid or EIA test (Positive; Negative; Indeterminate;
Results not found; Not tested; Not tested, known to be infected; Refused; Unknown). If
there is an indication in the chart that the test was ordered and done, but no results can
be found in the chart indicate that by putting ‘Results not found’ in the space provided.
Record as ‘Unknown’ if there is not indication of HIV testing or results in any of the
records abstracted.
•
Test - Enter the type of test performed (Rapid, EIA, Not documented).
•
Date - Note the date the blood was drawn.
Q.25b SECOND SCREENING: If the mother had a negative or indeterminate result for the first
screening or refused testing the first time it was offered, provide a response for the second
screening.
Q.25c THIRD SCREENING: If the mother had a negative or indeterminate result for the first and second
screening or refused testing the first and second time it was offered, provide a response for the
third screening.
Q. 26
MOTHER’S HIV SCREENING AT TIME OF LABOR AND DELIVERY TABLE:
An expedited HIV test is a standard EIA test performed with rapid turnaround time.
•
Results - Enter the results of rapid, expedited EIA, or EIA test (Positive; Negative;
Indeterminate; Results not found; Not tested; Not tested, known to be infected; Refused;
Unknown). If there is an indication in the chart that the test was ordered and done, but no
results can be found in the chart indicate that by putting ‘Results not found’ in the space
provided.
•
Test - Enter the type of test performed (Rapid, Expedited EIA, EIA, Not documented).
08/29/06
Page 14 of 27
•
Date and time results received at labor and deliver - Note the date and time the
laboratory results were received at labor and delivery. This information is important to
knowing if the test results were received in time to initiate antiretroviral medication. This
date and time can also be compared to the date and time of initiation of neonatal
antiretroviral medications to determine timeliness for prevention of HIV infection. 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).
Q.26b SECOND SCREENING: If the mother had a rapid test, refused testing, or results not found,
negative or indeterminate for her first screening at labor and delivery, provide a response for the
second screening only if it was not a confirmatory test. If second screening was a confirmatory
test, skip to Q.26c.
Q.26c CONFIRMATORY TEST: If the mother had a rapid test, refused testing, or results not found,
negative or indeterminate for the first and/or second screening, provide a response for the
confirmatory test. Response is not needed if the mother’s first screening was a confirmatory test.
Q. 27
WERE CD4 COUNTS OBTAINED DURING PREGNANCY: CD4 counts should be noted in
number of cells/mL. CD4% is the part of the absolute lymphocyte count that is CD4 cells and
equals CD4/(CD4+CD8). In AIDS, the CD4 (T4) cells are severely reduced, and the CD4/CD8 or
T4/T8 ratio is <1. Note the date of the CD4 tests.
If the mother received CD4 testing during pregnancy, be sure to indicate ‘Yes’ and complete the
chart provided in Q. 27a.
Q. 27a IF YES, LIST BELOW: The purpose of this question is to have an idea of the stage of HIV
disease of the mother at the time of pregnancy. If no CD4 counts or percentages are available
during pregnancy, CD4 counts and percentages within 6 months before pregnancy would be
useful to record. If more than three are recorded in the records, prioritize those CD4 counts and
percentages closest to delivery. Additional CD4 counts can be recorded in the comments section
at the end of the form. Note: Fields for entry of CD4 count alternate with those for CD4 percent.
•
Date Blood Drawn: This is the date the blood was drawn.
Q. 28
DID MOTHER HAVE VIRAL QUANTIFICATION TESTS PERFORMED DURING PREGNANCY:
Viral load testing has become the standard of care for monitoring response to therapy in HIVinfected patients. For more information on guidelines for reporting of viral load lab test results
see: Centers for Disease Control and Prevention. Guidelines for laboratory test result reporting of
human immunodeficiency virus type 1 ribonucleic acid determination: recommendations from a
CDC working group. MMWR 2001;50(No. RR-20). These guidelines are available at
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5020a1.htm.
If the mother received viral load testing during pregnancy, be sure to indicate ‘Yes’ and complete
the chart provided in Q. 28a.
Q. 28a IF YES, LIST BELOW: Remember to enter the viral load test results into HARS.
If no viral loads are available during pregnancy, viral loads within 6 months before pregnancy
would be useful to record. If more than three are recorded in the records, prioritize those viral
loads closest to delivery.
•
Results in copies/mL and Results in logs: Viral load results must be reported as either
copies/mL or log 10. Results for copies/mL must be reported according to the reportable
range. The range for each type of test is included in the reference table below. If results
are below the lower limit of detection, report it as ‘below lld’ (lower limit of detection); if
results are above the upper limit of detection, report it as ‘above uld’ (upper limit of
detection).
•
Date Blood Drawn: This is the date the blood was drawn.
08/29/06
Page 15 of 27
The following reference table will help you complete the chart in Q. 28a.
Reportable Range
(copies/mL) #
Company
Assay Type
Roche
RT-PCR
Bayer
bDNA
75 - 500,000
bioMerieux
NASBA
50 - 1,000,000
Primagen
NASBA
500 - 50,000,000
S*: 400 - 750,000
US*: 50 - 75,000
*S = standard, US = ultrasensitive
Q. 29
WHAT WAS MOTHER’S MOST ADVANCED HIV CLASSIFICATION DURING PREGNANCY:
Indicate the highest level in the HIV/AIDS case definition hierarchy: (in descending order) 1) AIDS
with an indicator condition (OI), 2) AIDS based on CD4 criteria only (i.e., CD4 cells <200 or CD4%
≤14%), 3) HIV (not AIDS), 4) Not Documented, or 5) Record not available. For example, an
opportunistic infection in the ninth month would supersede a CD4 <200 at any point. For women
who were diagnosed after their child’s birth, mark ‘Not documented’. If during record abstraction
for this project, you find information (i.e., lab data or OI information) that would change the
mother’s classification from that currently in HARS, indicate the new classification here and be
sure to update HARS. This question should be consistent with the information in Q. 28a above.
Q. 30
WAS MOTHER’S HIV STATUS NOTED IN HER PRENATAL CARE MEDICAL RECORDS:
Mark ‘Yes, 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’.
Mark ‘Yes, 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.
If the progress notes in the prenatal records state that this is a woman at risk for HIV infection but
that her HIV infection status is unknown, the answer to this question would be ‘No’.
Situations where a 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. In these instances, the response
would be ‘No’.
For women who have not received any prenatal care, mark ‘No prenatal care’.
08/29/06
Page 16 of 27
V. Antiretroviral Agents in Pregnancy
Questions 31-35
This section provides information on the types of antiretroviral therapies provided to the mother
during her pregnancy and labor/delivery as well as CD4 counts and viral loads after pregnancy.
Hierarchy of records for response gold standard (Q. 31 and 31a): If conflicting information is found for
any of the antiretroviral agents in pregnancy questions, refer to this list to determine which response to
include unless abstractor is positive of the correct response.
1. Maternal HIV Clinic
2. Prenatal Care
3. Labor and Delivery
4. Pediatric Birth
5. Pediatric non-HIV
6. Pediatric HIV
7. Health Department
Hierarchy of records for response gold standard (Q. 33 and 33a): If conflicting information is found for
any of the antiretroviral agents at labor and delivery questions, refer to this list to determine which
response to include unless abstractor is positive of the correct response.
1. Labor and Delivery
2. Pediatric Birth
3. Maternal HIV Clinic
4. Pediatric non-HIV
5. Pediatric HIV
6. Health Department
Hierarchy of records for response gold standard (Q. 34 – 35b): If conflicting information is found for
any of the maternal HIV care after delivery questions, refer to this list to determine which response to
include unless abstractor is positive of the correct response.
1. Maternal HIV Clinic
2. Health Department
Q. 31
WAS MOTHER PRESCRIBED ANY ANTIRETROVIRAL MEDICATION DURING THIS
PREGNANCY: ‘During this pregnancy’ refers to the time up to, but not including, labor and
delivery. If the mother was previously taking, began taking or restarted antiretroviral medications
after interruption during the 1st trimester, answer this question as ‘Yes’. If the specific drugs she
received are unknown, complete the grid and write ‘Unknown” in the ‘Drug Name’ column.
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 ZDV or other
ARV during pregnancy in HARS.
•
Was 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
08/29/06
Page 17 of 27
•
•
•
•
•
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. 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 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.
Q. 31a IF NO ARV WAS PRESCRIBED IN PREGNANCY, INDICATE REASON:
•
No prenatal care - The mother did not receive any prenatal care during her pregnancy.
•
HIV status of mother unknown - The physician may not have known the HIV status of
mother because she refused testing or the physician did not offer testing. Sometimes the
mother is not identified as being HIV positive until after delivery.
•
Mother known to be HIV negative during pregnancy - If the mother tested HIV
negative during pregnancy (with no further testing to indicate HIV seroconversion), she
would not receive ARV for prevention of perinatal transmission. There must be evidence
of a negative test during pregnancy in the chart; do not use patient report.
•
Mother Refused - Mother refused ARV during pregnancy.
•
Other - If ‘Other’ is indicated, be sure to specify why ARV was not prescribed.
•
Not Documented - Indicate ‘Not Documented’ if the woman was not prescribed ARV but
the reason why is not known.
Q. 32
WAS MOTHER’S HIV STATUS NOTED IN HER LABOR/DELIVERY MEDICAL RECORDS:
This information may be found in the history or progress notes, or on a lab report.
Mark ‘Yes, 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 AZT.
Mark ‘Yes, Negative’ if there is indication of a negative test during pregnancy or at labor and
delivery.
Q. 33
DID MOTHER RECEIVE ANTIRETROVIRALS DURING LABOR AND DELIVERY: 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. If, ‘Yes’, complete the grid for
all drugs received during labor and delivery. If the specific drugs she received are unknown,
complete the grid and write ‘Unknown” in the ‘Drug Name’ column.
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.
08/29/06
Page 18 of 27
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 not included in the list.
08/29/06
Page 19 of 27
•
•
•
•
Drug Name - Using the antiretroviral drug list, note all antiretroviral medications either
used or refused during labor and delivery. 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 ZDV or other ARV at labor and delivery in HARS.
Was 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.
Date Received/Time Received - Enter the date and time the antiretroviral medications
were begun. Enter ‘ ’ (blank) for unknown values (i.e., 03/ /2005 or ..:..)). 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).
Type if Administration - The medication record, nurses notes, physician’s progress
notes, and copies of physician’s orders should document the administration of
antiretroviral medications if they were given. The physician’s orders will generally have
the nurse’s initials next to the orders as indicating that they carried out the order.
Zidovudine (AZT, ZDV) would usually be administered intravenously (IV). Some hospitals
may not have an adequate stock of IV on hand and may give it orally rather than do
nothing. ‘PO’ is the standard medical abbreviation for orally. If it is noted in the chart that
the drug was given, but the route was not documented, check ‘Rcvd, route not
documented’.
Q. 33a IF NO ARV WAS RECEIVED DURING LABOR & DELIVERY, INDICATE REASON:
•
Precipitous delivery/STAT c-section - In some cases an eminent delivery of an infant
may preclude prescription and/or administration of ARV.
•
Prescribed but not administered - There are instances where a physician has ordered
the medication, but the mother never received it. Possible reasons would include not
having the specific ARV in the hospital pharmacy. If the ARV was prescribed but not
administered because the women delivered prior to administration, check the previous
box for ‘Precipitous delivery/STAT c-section’.
•
HIV 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.
•
Not Documented - Indicate ‘Not Documented’ if the woman was not prescribed ARV but
the reason why is not known.
Q. 34
WAS MOTHER REFERRED FOR HIV CARE AFTER DELIVERY: If the mother receives CD4 or
viral load testing (Q. 35a and 35b) 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’.
08/29/06
Page 20 of 27
Q. 35
INDICATE FIRST VIRAL LOAD AND/OR CD4 AFTER DISCHARGE FROM THE HOSPITAL:
This question is most relevant for those project areas that have laboratory reporting of CD4 counts
and viral loads. If the mother receives CD4 or viral load testing this information can be used as a
marker that the mother has received care after delivery.
Q. 35a INDICATE FIRST CD4 RESULT AFTER DISCHARGE: 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. For more information on
collection of CD4 counts and percent, see Q. 27a. If there is no indication of a subsequent CD4
result, mark ‘Not Done’.
Q. 35b INDICATE FIRST VIRAL LOAD AFTER DISCHARGE: For more information about viral load
testing and how to complete the chart see Q. 28a. If there is no indication of a subsequent viral
load result, mark ‘Not Done’.
VI. Birth History
Questions 36-42
This section provides information on the birth history of the infant, including the type of birth,
dates of labor/delivery, infant’s gestational age, mode of delivery, and infant birthweight.
Hierarchy of records for response gold standard: If conflicting information is found for any of the birth
history questions, refer to this list to determine which response to include unless abstractor is positive of
the correct response.
1. Labor and Delivery
2. Pediatric Birth
3. Birth Certificate
4. Pediatric non-HIV
5. Pediatric HIV
6. Health Department
Almost all of the information in this section is routinely available on the labor and delivery summary record,
a standard part of the chart (the form itself may vary from hospital to hospital but contains much of the
same information).
Q. 36
TYPE OF BIRTH: Multiple births are entered into HARS as separate records. If there were
multiple births (e.g. twins), each infant should have a separate Enhanced Surveillance Form
completed and have a unique Stateno number in HARS.
Note: If the birth is a multiple birth (twins, triplets) you will need to complete a separate data
abstraction form for each infant. (The mother’s information does not need to be completed on the
second form except for noting all variables in the Basic Demographics section.) Be sure
abstraction forms for multiple births are submitted for data entry and stored together.
Q. 37
BIRTH INFORMATION: 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).
•
Admission to L/D - Time of admission should be available on the face sheet (likely
stamped on this sheet). If possible, record the time of admission to Labor and Delivery
(L&D), rather than to hospital. A short time between admission and delivery (‘precipitous
delivery’) may be a reason for not receiving IV ZDV. 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
08/29/06
Page 21 of 27
•
•
•
and sent home, then readmitted for delivery.
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.
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 HARS if necessary.
Q. 38
GESTATIONAL AGE AT TIME OF DELIVERY: This age should be recorded in weeks. Round
the number down to the nearest whole digit (i.e., 38 6/7 would be 38 weeks).
Q. 39
MODE OF DELIVERY: This 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. The mode of
delivery is usually noted there. If the delivery was C-section, complete Q. 39a.
Q. 39a IF C-SECTION DELIVERY: 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.’ Non-elective (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
in the child’s records are acceptable even if no birth records are available. Check the appropriate
response. If not documented, check ‘Not specified’.
Q. 40
INSTRUMENTATION USED:
None - if there was not indication that an instrument was used.
Forceps - forceps are applied to the head of the infant to assist in delivering the infant.
Vacuum - a vacuum is applied to the head of the infant to assist in delivering the infant.
Forceps and vacuum- combination of the two methods
Not specified - if the type of delivery is not available, note ‘Not specified’.
•
•
•
•
•
Q. 41
CHILD’S BIRTH WEIGHT: This is usually listed on the delivery summary sheet. It will often
already be listed in grams but sometimes will only be in pounds. Record weight in lbs/oz or grams
(One kilogram is 1000 grams). The EPS software converts pounds/ounces to grams.
Q. 42
WAS MOTHER’S HIV STATUS NOTED ON THE EXPOSED CHILD’S BIRTH RECORD:
08/29/06
Page 22 of 27
Indicate if mother’s HIV status was noted in the birth record.
VII. Pediatric History
Questions 43-51
This last section provides information on antiretroviral therapies and prophylaxis for the infant,
results of infant antibody or DNA/RNA screening(s), current infant HIV infection status,
breastfeeding information, types of infant birth defects (if any), and cause(s) of death if the infant is
deceased.
Hierarchy of records for response gold standard (Q.43 – 45): If conflicting information is found for any
of the pediatric ARV and testing history questions, refer to this list to determine which response to include
unless abstractor is positive of the correct response.
1. Pediatric Birth
2. Pediatric HIV
3. Pediatric non-HIV
4. Health Department
Hierarchy of records for response gold standard (Q.46 – 48): If conflicting information is found for any
of the pediatric infections status and PCP questions, refer to this list to determine which response to
include unless abstractor is positive of the correct response.
1. Pediatric HIV
2. Pediatric non-HIV
3. Health Department
Hierarchy of records for response gold standard (Q.49): If conflicting information is found for any of
the breastfeeding question, refer to this list to determine which response to include unless abstractor is
positive of the correct response.
1. Pediatric non-HIV
2. Pediatric HIV
3. Pediatric Birth
4. Health Department
Hierarchy of records for response gold standard (Q.50 and 50a): If conflicting information is found for
any of the birth defects questions, refer to this list to determine which response to include unless
abstractor is positive of the correct response.
1. Pediatric non-HIV
2. Pediatric HIV
3. Pediatric Birth
4. Birth Certificate
5. Health Department
Pediatric Laboratory Data (for HARS): Be sure to complete the standard pediatric HIV/AIDS case report
form under section VII including all HIV diagnostic tests (type, results and date of test). Begin with the
earliest test. Also collect additional CD4 results and enter CD4 data into HARS, specifically including the
first, most recent, and closest to current diagnostic status. Collect all available viral load data and enter
into HARS. Include the type of test, viral copies per mL, and date of test. Results of number of viral copies
per milliliter of plasma and date of test can be collected for each of the three commercially available
assays: 1) branched DNA (bDNA) 2) nucleic acid sequence-based amplification (NASBA) 3) quantitative
RNA PCR. There is also an ‘other viral load assay’ option in HARS for any new viral load tests developed
and licensed in the future.
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 HARS updates (e.g., new HIV diagnostic tests, CD4 counts, treatment,
08/29/06
Page 23 of 27
prophylaxis, AIDS-defining conditions, 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 (Q.43 - Q.51) or updated. The updated infant’s CD4 counts and viral load test results should
be entered directly into HARS.
Q. 43
WAS CHILD PRESCRIBED ANY ANTIRETROVIRALS FOR PERINATAL HIV PREVENTION
DURING THE FIRST SIX WEEKS OF LIFE: 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. If the answer to this question is ‘Yes’, complete the grid. If the specific drugs the
child was prescribed are unknown, complete the grid and write ‘Unknown” in the ‘Drug Used’
column.
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 the drugs not included in the list.
•
Drug Name - Using the antiretroviral drug list, note all antiretrovirals either used or
refused during the first six weeks of life. If the specific drugs the child was prescribed or
the mother refused are unknown, complete the grid and write ‘Unknown” in the ‘Drug
Name’ column. Also, be sure to complete the date neonatal ZDV or other ARV started in
HARS.
•
Was 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 mother refused medications for a child if the child did not receive antiretroviral drugs -they may not have been offered. Only code ‘refused’ if refusal is documented. Our goal
is to sort out children who did not receive drugs because it was not offered to them, and
those who did not receive it because mothers refused it.
•
Date Drug Started and Time Started - The PHS recommendations state that the
neonatal component of the ACTG protocol 076 consisting of 6 weeks of neonatal
prophylactic ZDV therapy should begin within 8-12 hours of birth. Therefore, to monitor
implementation and impact, we collect the date and time of day the child was first started
on antiretrovirals for prophylaxis. If the child was prescribed an antiretroviral drug, record
the date and time of day the child was started on the drug used as prophylaxis during the
first 6 weeks of life. Enter ‘XX’ for unknown values (i.e., 03/XX/2005 or XX:XX).
•
Regimen Completed - If the child completed the prescribed regimen of antiretroviral
drugs, check ‘Yes’, if not, check ‘No’. If the regimen was not completed, enter the Stop
Date and the Drug Stop Code. Zidovudine is generally prescribed for 6 weeks.
•
Stop Date - If the drug was stopped (discontinued) prior to completion of regimen,
indicate ‘Yes’, the drug was stopped.
•
Drug Stop Code - To answer this question, use the ‘S’ codes found at the end of the data
abstraction form. 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 written in the physician’s notes. Do not attempt to
provide reasons if they are not clearly documented in the chart.
Q. 43a IF NO ARV WAS PRESCRIBED IN FIRST SIX WEEKS OF LIFE, 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.
08/29/06
Page 24 of 27
•
•
•
Q. 44
Q. 45
Mother Refused - Mother refused ARV for infant during first six weeks of life.
Other - If ‘Other’ is indicated, be sure to specify why ARV was not prescribed.
Not Documented - Indicate ‘Not Documented’ if the infant was not prescribed ARV but
the reason why is not known.
INFANT’S HIV ANTIBODY TESTING TABLE:
Rapid tests are tests done at the bedside or locally rather than being sent out, which ensures
rapid ‘turnaround’ of results. ELISA and Western Blot are not rapid tests. An expedited HIV test
is a standard EIA test performed with rapid turnaround time.
•
Results - Enter the results of rapid, expedited EIA, or EIA testing (Positive; Negative;
Indeterminate; Results not found; Not tested; Refused; Unknown). If there is an indication
in the chart that the test was ordered and done, but no results can be found in the chart
indicate that by putting ‘Results not found’ in the space provided.
•
Test - Enter the type of test performed (Rapid, Expedited EIA, EIA, Not Documented).
•
Date blood drawn - Note the date the blood was drawn.
RESULTS OF DNA/RNA SCREENING TABLE:
Results - Enter the results of DNA or RNA testing (Positive; Negative; Indeterminate;
Results not found; Not tested; Refused; Unknown). If there is an indication in the chart
that the test was ordered and done, but no results can be found in the chart indicate that
by putting ‘Results not found’ in the space provided.
•
Test - Enter the type of test performed (DNA, RNA). The most commonly used DNA PCR
test is Amplicor/COBAS HIV-1 DNA test. The most commonly used RNA PCR test is
Procliex RNA test.
•
Date blood drawn - Note the date the blood was drawn.
•
Q. 46
WHAT IS THE CHILD’S CURRENT HIV STATUS: This question is especially important for those
project sites that are not currently sending CDC a HARS record on all HIV-exposed children. See
MMWR 1999;48(No.RR-13):29-31 for the pediatric case definitions of HIV infection and AIDS.
This publication is available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr4813a2.htm
Q. 47
IF CHILD’S HIV STATUS IS INDETERMINATE, INDICATE WHY: This question is included on
the pediatric HARS software (although is not found on the pediatric case report form). It is found
immediately after the question about diagnostic status of the child (variable name is ‘followup’).
The codes used for this question are the similar to those found in HARS.
Q. 48
WAS PCP PROPHYLAXIS RECEIVED IN THE FIRST YEAR OF LIFE: Examples of drugs used
for 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 of time. For example, TMP/SMX is usually used for 10
days 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 chart or given for a period of 2 weeks or longer. If
there is nothing in the chart that indicates the use of any of these drugs or that refers to the
prophylactic treatment of PCP, then check ‘No’. ‘Not Documented’ is used if treatment information
in the chart is unclear or not documented.
This question refers only to the child’s first year of life. If the child received or is receiving PCP
prophylaxis, enter the month, day and year the child was started on therapy to prevent the
occurrence of Pneumocystis carinii pneumonia (PCP). If the year and month are present without
a designated day, ‘XX’ should be entered for the day followed by the documented year and month.
Information about PCP prophylaxis is also contained in HARS but refers to PCP prophylaxis
started at any age not just within the 1st year of life.
Please refer to appendix K2 in the surveillance guidelines [MMWR 1995;44(RR-4):1-11] for the
revised guidelines for prophylaxis against PCP for children.
08/29/06
Page 25 of 27
Q. 49
WAS CHILD BREASTFED (HARS): If child was breastfed at any time, check ‘Yes’ and complete
the duration in days or weeks. If duration is not known, check ‘Not Documented.’ This information
will usually be found in the nurse’s notes in the delivery chart, in the daily summary notes, or in the
pediatric chart of routine visits. If the child was fed the mother’s expressed breast milk, this
question should be answered ‘Yes’. Avoidance of breastfeeding to prevent postpartum
transmission of HIV has been recommended for HIV-infected mothers in the U.S. If there is
suspicion that the child’s only exposure to HIV was through breast milk, note that on the front
page of the Enhanced Surveillance Form and alert the state or local NIR Coordinator and CDC.
Q. 50
WERE ANY BIRTH DEFECTS NOTED IN THE FIRST YEAR OF LIFE: The goal of collecting
birth defect information on children born to HIV-infected mothers is to systematically assess, on a
population basis, any potential short term adverse outcomes of zidovudine or other antiretroviral
exposure in utero. 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 to those
who were not exposed and to that of 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 to code these defects have been
developed by the CDC Division of Birth Defects and Developmental Disabilities, National Center
for Environment Health and are currently used in the Metropolitan Atlanta Congenital Defects
Program, an active surveillance system for birth defects in the Atlanta metropolitan area.
The Division of Birth Defects and Developmental Disabilities, NCEH, CDC, developed specific 6digit codes based on the 1979 British Pediatric Association Classification of Diseases and the
World Health Organization’s 1979 International Classification of Diseases, 9th Revision, Clinical
Modification (ICD-9-CM). Five fields of codes can be entered in HARS. These 6-digit codes are
explained and are indexed in Appendix A. The 6 digit code is based on a 3 or 5 digit ICD-9 code.
The ICD-9 code, which may be available in the child's medical record, can be used on the HARS
form and software in place of the 6-digit code. If defects exist, list them all on the HARS case
report form and enter into the comment section of HARS. Call the Enhanced Perinatal
Surveillance Coordinator for assistance with coding.
To look for possible birth defects, review newborn and hospital records including the face sheet,
history and physical, discharge summary, operative, laboratory, x-ray, cardiac catheterization,
autopsy reports, physicians’, nurses’, social, and psychological services’ notes, and consultations.
In addition, birth defect (i.e. congenital anomalies) information is also collected on the standard
U.S. birth certificate. Hospital records should be reviewed to determine if a reportable defect is
present. Each reportable condition is coded separately according to the 6 digit code. These
codes are based on ICD-9 codes but provide more specific diagnostic information. If reportable
birth defects are diagnosed, check ‘Yes’ and abstract all diagnoses onto the EPS Date Abstraction
Form and the HARS case report form. Also include discrepant diagnoses and those mentioned
once in the chart that have not been specifically 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 as to whether a diagnosis is a birth defect and should be reported
please call the Enhanced Perinatal Surveillance Coordinator. For reference, you may request the
full copy of the Metropolitan Atlanta Congenital Defects Program Procedure Manual from the EPS
Coordinator.
Another source of information would be a HARS match with the local birth defects surveillance
registry.
Q. 51
IF CHILD DECEASED, FROM DEATH CERTIFICATE, LIST: Legibly print the causes of death
in the appropriate space provided exactly as it appears on the death certificate. If the ICD-9 or
ICD-10 code is included on the death certificate that you review you should include those on the
abstraction form. If codes do not appear on the death certificate, the causes of death will be
assigned an ICD-9 or ICD-10 code at CDC. Do not, however, code these causes of death
yourself.
08/29/06
Page 26 of 27
Note: The last listed cause of death in part 1 of the death certificate is usually the underlying
cause of death.
Last Updated on January 8th, 2009
08/29/06
Page 27 of 27
| File Type | application/pdf |
| File Title | Enhanced HIV/AIDS Surveillance To Maximally Reduce Perinatal HIV Transmission |
| Author | DHAP_USER |
| File Modified | 2009-11-02 |
| File Created | 2009-06-23 |