Download:
pdf |
pdfAttachment H. Supplemental Surveillance Activity 3: Enhanced Perinatal Surveillance
(EPS) Data Collection Form, Form Instructions, and Procedural Guidance.
Status: new
Description: New form included.
Infant State No: ___________________
Enhanced HIV/AIDS Surveillance to Maximally Reduce Perinatal HIV Transmission
New
Updated
OMB No. 0920-XXXX Exp. Date XX/XX/XXXX
Initials of person completing the form (print legibly)______________________
INFORMATION COMPLETE FOR ANALYSIS
Yes
No
Date form completed [e.g., abstraction concluded] __ __/__ __/__ __ __ __ (mm/dd/yyyy)
Date form received by main facility: __ __/__ __/__ __ __ __(mm/dd/yyyy)
Date case was reported: __ __/__ __/__ __ __ __(mm/dd/yyyy)
How was the infant first identified?
Routine case reporting - Pediatric report
Routine case reporting - Maternal report
Birth registry match
Active case finding for Enhanced Perinatal Surveillance
Laboratory Reporting
Other than routine surveillance activities, specify _____________________________
If maternal information is not available, was the child adopted, in foster care, or abandoned.
Yes
No
Not Applicable
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 ______________________________
BASIC DEMOGRAPHICS
2. Infant
Reporting state ________________(REQUIRED FIELD)
3. Mother
Reporting state _______________
State No. _____________________ (REQUIRED FIELD)
State No. ____________________
City No. ______________________
City No. _____________________
Soundex _____________________
Soundex ____________________
Date of Birth __ __/__ __/__ __ __ __ (HARS) (REQUIRED)
Date of Birth __ __/__ __/__ __ __ __ (HARS)
Date of Death __ __/__ __/__ __ __ __ (HARS)
Date of Death __ __/__ __/__ __ __ __ (M-HARS)
Sex at Birth ____ (HARS)
Public reporting burden of this collection of information is estimated to average 25 minutes per response, including the time for reviewing instructions, searching existing
data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a
person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or
any other aspect of this collection of information, including suggestions for reducing this burden to CDC, Project Clearance Officer, 1600 Clifton Road, MS D-74, Atlanta,
GA 30333, ATTN: PRA (0920-XXXX). Do not send completed form to this address.
08/28/2006
Page 1 of 12
Infant State No: ___________________
4. Mother's Country of Birth ___________________(HARS)
4a. If Country is unknown, but Continent of birth is known, specify ______________________
5. Mother's Hispanic Ethnicity (M-HARS-modified)
Yes
No
Unknown
6. Mother's Race (Mark all that apply) (M-HARS-modified)
American Indian/Alaska Native
Hawaiian/Pacific Islander
Unknown
Asian
White
Black/African American
Other Race, specify ___________________
7. Marital Status (at time of delivery)
Single
Divorced
Married
Widowed
Separated
Unknown
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 __________________________________________________
PRENATAL CARE
9. Did mother receive any prenatal care for this pregnancy?
Yes
No (Go to Q15)
Not Documented (Go to Q15)
10. Date of first prenatal care visit: __ __/__ __/__ __ __ __ (mm/dd/yyyy)
11. Month of pregnancy prenatal care began: _______ (mos) (99=unk) (HARS)
OR _______ (in weeks, if month is not noted in chart)
12. Date of last prenatal care visit prior to delivery: __ __/__ __/__ __ __ __ (mm/dd/yyyy)
13. Number of prenatal care visits: (e.g., visits specifically for prenatal care) ______ (99=unk) (HARS)
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
08/28/2006
Page 2 of 12
Infant State No: ___________________
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
__ __/__ __/__ __ __ __
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
__ __/__ __/__ __ __ __
17. Mother's reproductive history:
____ Number of previous pregnancies
____ Number of previous live births
____ Number of previous miscarriages/stillbirths
____ Number of previous induced abortions
or [ ____ Total number of previous abortions ]
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 ___/___
____
______________
__________
Sib 2
__ __/__ __/__ __
___:___ as of ___/___
____
______________
__________
Sib 3
__ __/__ __/__ __
___:___ as of ___/___
____
______________
__________
Sib 4
__ __/__ __/__ __
___:___ as of ___/___
____
______________
__________
Sib 5
__ __/__ __/__ __
___:___ as of ___/___
____
______________
__________
Sib 6
__ __/__ __/__ __
___:___ as of ___/___
____
______________
__________
*HIV Status:
[1] Infected
[2] Uninfected
[3] Indeterminate
[9] Not
Documented
–
08/28/2006
Page 3 of 12
Infant State No: ___________________
SUBSTANCE USE
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)
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
19b. If any substances used, were any of the drugs injected?
Yes
No
Not Documented
Specify which substance(s) were injected: ____________________________________________
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
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
22. If indication of substance use, was the mother referred for treatment during or after this pregnancy?
Yes
No
Not Documented
08/28/2006
Page 4 of 12
Infant State No: ___________________
MATERNAL TESTING/CLINICAL INFORMATION
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
24. Date of mother's first positive confirmatory test (earliest known test): __ __/__ __/__ __ __ __ (HARS)
(Confirmatory test is Western Blot or IFA)
(mm/dd/yyyy)
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)
___________________
___________
__ __/__ __/__ __ __ __
25c. Third Screening (if negative or refused second screening)
___________________
___________
__ __/__ __/__ __ __ __
§ Results
Positive
Negative
Indeterminate
Results not found
Not tested
Not tested, known to be infected
Refused
Unknown
*Tests
Rapid
EIA
Not Documented
26. Mother’s HIV screening at time of labor and delivery.
ONTINUED –
Results§
Test *
Date Results at L&D
(see below)
(see below)
(mm/dd/yyyy)
26a. First Screening
___________________
Time† Results at
L&D
(see below)
___________
__ __/__ __/__ __ __ __
__ __:__ __
26b. Second Screening (if applicable)
___________________
___________
__ __/__ __/__ __ __ __
__ __:__ __
26c. Confirmatory Test
___________________
__ __/__ __/__ __ __ __
__ __:__ __
§ Results
Positive
Negative
Indeterminate
Results not found
Not tested
Not tested, known to be infected
Refused
Unknown
08/28/2006
___________
*Tests
Rapid
Expedited EIA
EIA
Not Documented
† Military time
noon = 12:00
4:30pm = 16:30
midnight = 00:00
12:30am = 00:30
Page 5 of 12
Infant State No: ___________________
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
__ __/__ __/__ __ __ __
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)
29. What was mother's most advanced HIV classification during pregnancy:
HIV, not AIDS
AIDS, CD4 criteria only
AIDS, indicator condition
30. Was mother's HIV status noted in her prenatal care medical records?
Yes, Positive
Yes, Negative
No
No prenatal care
08/28/2006
HIV negative
Not Doc
RNA
Record Not Available
Page 6 of 12
Infant State No: ___________________
ANTIRETROVIRAL THERAPY
31. Was mother prescribed any antiretroviral medication during this pregnancy? (HARS)
Yes (Complete Table)
Drug Name
(Use drug list)
Was
Drug
Refused
No (Go to Q31A)
Date Drug Started
(mm/dd/yy)
Not Documented (Go to Q32)
Gestational
Age
Started
(weeks,
round
down)
Drug Stopped
RNA (Go to Q32)
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, __ __/__ __/__ __
____
Yes __ __/__ __/__ __
vii. ______________
(After completing table, Go to Q32)
____
If yes, __ __/__ __/__ __
____
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
32. Was mother's HIV status noted in her labor/delivery medical records?
Yes, Positive
Yes, Negative
No
Record Not Available
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)
Yes
__ __/__ __/__ __
__ __:__ __
ii. ___________________
Yes
__ __/__ __/__ __
__ __:__ __
iii. ___________________
Yes
__ __/__ __/__ __
__ __:__ __
iv. ___________________
Yes
__ __/__ __/__ __
__ __:__ __
v. ___________________
Yes
__ __/__ __/__ __
__ __:__ __
vi. ___________________
Yes
__ __/__ __/__ __
__ __:__ __
Yes
vii. __________________
__ __/__ __/__ __
(After completing table, Go to question 34)
08/28/2006
Type of Administration
Oral
i. ___________________
RNA (Go to Q34)
IV
Rcvd, route not doc
__ __:__ __
†
military time: noon = 12:00 midnight = 00:00
Page 7 of 12
Infant State No: ___________________
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
34. Was mother referred for HIV care after delivery?
Yes
No (Go to Q36)
Not Documented (Go to Q36)
Record Not Available (Go to Q36)
– VI. MOTHER’S CLINICAL INFORMATION –
35. If yes, indicate first viral load and/or CD4 after discharge from hospital up to 6 months:
35a. CD4:
CD4 Result
Not Done
Not Available
Units
Date blood drawn
(mm/dd/yyyy)
__ __ __ __
Count
__ __/__ __/__ __ __ __
__ __ __ __%
Percent
__ __/__ __/__ __ __ __
Not Done
Result in
copies/mL #
Result in
logs
Not Available
__________
_________
35b. Viral Load:
Date blood drawn
(mm/dd/yyyy)
__ __/__ __/__ __ __ __
BIRTH HISTORY
36. Type of birth: (HARS)
Single
Twin
Triplet or greater
37. Birth information:
Birth Outside Hospital
Record Not Available
Record Not Available
Time*
Date
(mm/dd/yyyy)
Onset of labor
__ __:__ __
__ __/__ __/__ __ __ __
Admission to L/D
__ __:__ __
__ __/__ __/__ __ __ __
Rupture of Membranes
__ __:__ __
__ __/__ __/__ __ __ __
Delivery
__ __:__ __
__ __/__ __/__ __ __ __
*military time: noon=12:00 midnight=00:00
38. Gestational age at time of delivery: __________ (weeks - round down to nearest whole wk) (HARS)
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)
08/28/2006
Page 8 of 12
Infant State No: ___________________
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
40. Instrumentation used:
None
Forceps
Vacuum
Forceps and vacuum
Not specified
41. Child's birth weight (lbs/oz or grams): _____ lbs. _____ oz
or
________ grams (HARS)
42. Was mother's HIV status noted on the exposed child's birth record?
Yes, Positive
Yes, Negative
No
Record Not Available
– VII. BIRTH HISTORY –
PEDIATRIC HISTORY
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)
Was
Drug
Refused
Date Drug Started
(mm/dd/yy)
Time† Started
(see below)
Regimen
Completed
Stop Date
(mm/dd/yy)
Drug
Stop
Codes
Yes No ND
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
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
08/28/2006
Page 9 of 12
Infant State No: ___________________
44. Infant’s HIV antibody testing.
Results§
(see below)
Test *
(see below)
Date Blood Drawn
(mm/dd/yyyy)
i. ___________________ ___________ __ __/__ __/__ __ __ __
ii. ___________________ ___________ __ __/__ __/__ __ __ __
iii. ___________________ ___________ __ __/__ __/__ __ __ __
§ Results
Positive
Negative
Indeterminate
Results not found
Not tested
Refused
Unknown
*Tests
Rapid
Expedited EIA
EIA
Not Documented
45. Results of DNA/RNA screening:
Results§
(see below)
Test
DNA
RNA
Date Blood Drawn
(mm/dd/yyyy)
i. ________________
__ __/__ __/__ __ __ __
ii. ________________
__ __/__ __/__ __ __ __
iii. ________________
__ __/__ __/__ __ __ __
iv. ________________
__ __/__ __/__ __ __ __
v. _________________
__ __/__ __/__ __ __ __
§ Results
Positive
Negative
Indeterminate
Results not found
Not tested
Refused
Unknown
46. What is the child's current HIV status? (HARS-modified)
AIDS
Confirmed HIV infected (not AIDS)
HIV negative
Indeterminate as of __ __/__ __/__ __ __ __ (mm/dd/yyyy)
47. If child's HIV status is indeterminate, indicate why: (HARS-modified)
Moved from state
Lost to Follow-up
Provider out of state
Died before status determined
Child less than 18 months of age
Not Documented
48. Was PCP prophylaxis prescribed in the first year of life? (HARS)
Yes, date started __ __/__ __/__ __ __ __
No
Not Documented
Record Not Available
49.Was child breastfed? (HARS)
Yes, duration ___ days ___ weeks ___not doc
Not Documented
Record Not Available
08/28/2006
No
Page 10 of 12
Infant State No: ___________________
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: _____._____
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.
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.
_______________________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
08/28/2006
Page 11 of 12
Infant State No: ___________________
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)
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
08/28/2006
PROTEASE INHIBITORS
Amprenavir (Agenerase)
Indinavir (Crixivan)
Kaletra (Lopinavir,
Ritonavir)
Nelfinavir (Viracept)
Ritonavir (Norvir)
Saquinavir (Fortavase,
Invirase)
Tipranavir (Aptivus)
OTHER
Adefovir dipivoxil (bis-POM,
PMEA, Preveon)
Atripla (Efavirenz & Tenofovir &
Emtricitabine)
If an antiretroviral drug
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
Page 12 of 12
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. Next to each question on the data abstraction
form that is included on the pediatric case report form and/or in the HARS software, we have indicated
‘(HARS)’. 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. Use of the EPS Date Worksheet, found at the end
of this document, is helpful in assessing consistency of dates. 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 26
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)
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, 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, 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’
A ‘99’ or ‘U’ 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.
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.
08/29/06
Page 2 of 26
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, ‘XX’ should be entered into the
appropriate space (e.g., 02/XX/2005). 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: Infant reporting state, Infant state
number and Infant date of birth. 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.
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: 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.
08/29/06
Page 3 of 26
•
•
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
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
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.
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, ‘XX’ should be coded in appropriate field (e.g. 02/XX/56).
08/29/06
Page 4 of 26
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.
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).
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. If there is documentation that the mother was in a common law marriage during
pregnancy, it is reasonable to consider her married. This will be a site decision.
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
08/29/06
Page 5 of 26
‘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
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
‘Unknown’, leave specify blank. If ‘Other’, then specify the documented risk.
II. Prenatal Care
Questions 9-18
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
08/29/06
Page 6 of 26
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.
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 ‘XX/XX/XXXX’.
If part of the date is unknown, ‘XX’ should be coded in appropriate field (i.e., 02/XX/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 ‘99’ 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.
08/29/06
Page 7 of 26
•
Not Documented - The type of facility is not documented in any of the source records. If
the physician’s name is documented but facility type is not listed, you may be able to
obtain the information from the abstracting facility’s personnel.
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. Documentation of the screening
should be in the chart regardless of the diagnosis. If there is no indication that a test was
conducted, mark ‘Not Documented.’ Responses of ‘Not Documented’ and ‘Record Not Available’
refer to both the prenatal and labor/delivery records.
•
Group B Strep (GBS) -Group B streptococci. A major cause of perinatal bacterial
infections and systemic and focal infections in infants. Invasive disease categorized into
early onset (1st week of life) and late-onset (usually at 3-4 weeks of life). Colonization late
in pregnant women and newborns ranges from 5% to 35%. Intrapartum
chemoprophylaxis is IV Penicillin G. Two types of prevention strategies may be used:
screening all pregnant women at 35 to 37 weeks for vaginal & rectal GBS
colonization, offering intrapartum chemoprophylaxis to those identified as GBS
carriers OR
risk factor based strategy - prophylaxis given to women with intrapartum risk
factors: gestation < 37 weeks, ≥ 18 hours since rupture of membrane,
temperature 38° C or greater.
•
Hepatitis B (Hepatitis B surface antigen, HBsAg) - Detects acutely or chronically infected
persons. Prenatal HbsAg screening of all pregnant women is recommended. Babies of
mothers who are HbsAg (+) must have HBIG & HBV vaccine within 12 hours of birth to
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.
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. The diagnosis of one of the conditions listed below prior to the
pregnancy should not be included unless there is a recurrence of or chronic infection during the
pregnancy. 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). It is not necessary to have a lab sheet to record
a diagnosis on the EPS abstraction form. Diagnoses may be presumptive or definitive depending
on various signs, symptoms and lab tests. If there is no indication that a test was conducted,
mark ‘Not Documented.’ Responses of ‘Not Documented’ and ‘Record Not Available’ refer to both
the prenatal and labor/delivery records. If a diagnosis is made either presumptively or definitively,
08/29/06
Page 8 of 26
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
(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
08/29/06
Page 9 of 26
•
Q. 17
(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.)
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
08/29/06
Page 10 of 26
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.
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. Make a note of
there being siblings in the abstractor’s notes section of the abstraction form if complete
information is not provided in the medical records.
III. Substance Use
Questions 19-22
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
08/29/06
Page 11 of 26
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
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
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
08/29/06
Page 12 of 26
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.
•
Before this pregnancy: includes early pregnancy if subject was tested before pregnancy
was diagnosed. If exact timing of test is unknown, but it is clear that the mother was
diagnosed prior to this pregnancy, mark ‘Before this pregnancy.’
•
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, ‘XX’ 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 was known to be
infected, but there is no indication of when she was tested in the medical record, enter the first
known test date. The site’s HIV/AIDS surveillance data should have the earliest confidential test
date if reportable. 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). Lab
documents may state that the results were reactive or non-reactive. In these instances
record the results as positive and negative, respectively. 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.
08/29/06
Page 13 of 26
•
•
Test - Enter the type of test performed (Rapid, EIA, Not documented). If the record just
states ‘HIV Screen,’ enter ‘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). Lab documents may state that the results were reactive or non-reactive. In
these instances record the results as positive and negative, respectively. 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). If
the record just states ‘HIV Screen,’ enter ‘Not Documented.’
•
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. Also include any tests performed at the hospital prior to delivery.
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.
Round all results to the nearest whole number.
08/29/06
Page 14 of 26
•
Q. 28
Date Blood Drawn: This is the date the blood was drawn.
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. Also include any tests performed at the hospital prior to delivery.
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 or 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.
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 the mother tested negative during the pregnancy and there is no
evidence of HIV infection, her HIV status during pregnancy should be indicated as HIV negative. HARS
does not reassign the infection status as HIV after the individual has met the AIDS case definition. Since
we are interested in the mother’s stage of disease during pregnancy, classification should be based on
what is in the medical records. If there is a difference among the records, choose the most advanced
stage of disease. 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. Physician documentation can be used to indicate the
HIV classification during pregnancy. This question should be consistent with the information in Q. 28a
08/29/06
Page 15 of 26
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’.
V. Antiretroviral Agents in Pregnancy
Questions 31-35
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
08/29/06
Page 16 of 26
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
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 ‘U’ for Unknown. Do not calculate gestational age if it is not in the
medical records.
•
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. If
the drug was stopped during the pregnancy but restarted after the birth of the child,
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
08/29/06
Page 17 of 26
•
•
•
Q. 32
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.
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.
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.
•
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. If a woman received multiple doses of an antiretroviral, only indicate the first
date and time of administration. Enter ‘XX’ for unknown values (i.e., 03/XX/2005 or
XX:XX)). 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’.
08/29/06
Page 18 of 26
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 outside of 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 (up to 6 months). 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’.
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’. If the women was referred to care or the abstractor has evidence that she
was in care, but there is no subsequent information regarding CD4 results, mark ‘Not Available’.
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’. If the women was referred to care or the abstractor has evidence
that she was in care, but there is no subsequent information regarding viral load results, mark ‘Not
Available’.
VI. Birth History
Questions 36-42
08/29/06
Page 19 of 26
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
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 ‘XX:XX’. 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,
08/29/06
Page 20 of 26
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. ‘HIV
Indication’ should only be marked if it is clear that this is the reason for conducting a C-section.
DO NOT mark this option just because the mother is HIV positive. 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. If the delivery is noted as
Normal Spontaneous Vaginal Delivery (NSVD), mark ‘None’. Also mark ‘None’ if there is
information regarding the delivery method, and there is no evidence that any instruments
were 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:
Indicate if mother’s HIV status was noted in the birth record.
VII. Pediatric History
Questions 43-51
08/29/06
Page 21 of 26
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
If abstraction is conducted prior to the specified time interval (i.e., 6 weeks for antiretroviral therapy, 1 year
for PCP), then leave the questions blank and complete at follow-up.
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,
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
08/29/06
Page 22 of 26
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. List all prescriptions, including single dose. 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. Indicate
‘Not Documented’ when pediatric records and information about completion are
unavailable.
•
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.
•
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.
08/29/06
Page 23 of 26
Q. 44
Q. 45
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). Record as ‘Negative’ if the results are
below the limit of detection. 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. If the
pediatric provider is unknown and there is no possibility of obtaining this information, the child
should be listed as indeterminate as of the date record abstraction was conducted and check lost
to follow-up.
Q. 47
IF CHILD’S HIV STATUS IS INDETERMINATE, INDICATE WHY: This question is included on
the pediatric HARS software (although it 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. If information is only
available through the child’s day of birth, abstractors should consider this child lost to follow-up.
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 24 of 26
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 25 of 26
Note: The last listed cause of death in part 1 of the death certificate is usually the underlying
cause of death.
Last Updated on October 17, 2006
08/29/06
Page 26 of 26
Procedural Guidance for Enhanced HIV/AIDS
Perinatal Surveillance
FY2006-FY2009
HIV/AIDS Incidence and Case Surveillance Branch
Division of HIV/AIDS Prevention
August 2006
CONTENTS
I. Introduction
A. Purpose of EPS
B. Background of Advancing HIV Prevention
C. History of EPS
D. Purpose and Use of EPS Procedural Guidance
II. Goals and Objectives
III. Partners in Cooperative Agreement
A. CDC
1. Project Officer
2. Project Coordinator
3. Data Manager
4. Analysis Working Group
B. State and Local Health Departments
1. Project Director
2. Project Coordinator
3. Abstractors/Data Entry Staff
4. Community Planning Groups/Prevention Program Partners
IV. Methods
A. Project Design
B. Project Sites
1. HIV Exposure Reporting
2. Non-HIV Exposure Reporting
C. Case Eligibility/Ascertainment
1. Cohort Birth Year
2. State/City of Birth Hospital v. State/City of Residence
3. Eligible Mother-Infant Pairs
4. Case Ascertainment
5. Case Finding
a. Active surveillance
b. Passive surveillance
6. Vital Statistics Birth Registry Match
7. Other Methods of Case Ascertainment
D. Data Collection
1. Data Sources
2. Data Collection Instruments
a. Historical changes to data collection form
b. Integration with HARS case reports
c. Abstracting data from medical records
d. Site-specific questions
3. Data Collection Procedures
a. Timing of collection
b. Attainment of records
08/16/2006
2 OF 40
E.
F.
G.
H.
I.
c. Completeness of reporting
d. Notation of abstraction procedures & anomalies
e. Follow-up of children
Data Management (Electronic Data Entry & Transfer)
1. Structural Requirements
2. Process Standards
a. Data entry
b. Edits
c. Processing follow-ups, corrections, and deletions
d. Documentation
3. Data Files
4. Data Analysis Files
5. Data Management Procedures
a. System backup
b. Computer virus protection
c. Quality control
d. Security and access to abstractions and computer files
e. Quarterly report generation
Data Quality
1. Structural Requirements
a. Procedure manuals, coding manuals, and other documentation
b. Edits and data processing
2. Process Standards
a. Adherence to data standards
b. Training
c. Quality control activities
d. Outcome measures
Data Analysis
1. Preparation for Analysis
a. Data complete for analysis
b. Data accuracy
c. Security and confidentiality
2. Features of Analyses
3. Site-Specific Analyses
4. National/CDC Analyses
Dissemination of Results
1. Ways to Use EPS Data
2. Ways to Disseminate EPS Data
3. Authorship Principles with CDC, Partners & External Researchers
4. Review of Abstracts and Manuscripts
Limitations of EPS data
V. Project Time Line
A. Ongoing activities
VI. Protection of Human Subjects
A. IRB Approval
08/16/2006
3 OF 40
B. Informed Consent
C. Protecting Privacy of EPS Data (Confidentiality and HIPAA)
References
Appendices
A. EPS Supplemental Medical Record Abstraction Form
B. Technical Guidance for HIV/AIDS Surveillance Programs: Pediatric HIV/AIDS Case
Reporting
C. EPS User’s Guide
D. Site-Specific Questions
E. Technical Guidance for HIV/AIDS Surveillance Programs: Access to Source Data and
Completeness of Reporting
F. Technical Guidance for HIV/AIDS Surveillance Programs: Data Quality
G. NCHSTP Determination of Applicability of Human Subjects Regulations
H. Example from New York City - IRB Approval for Site Specific Surveillance of
Mother/Infant Pairs
I. Assurance of Confidentiality
08/16/2006
4 OF 40
I. Introduction
A. Purpose of EPS
The purpose of the Enhanced Perinatal Surveillance (EPS) project is to target and follow the
progress toward maximal reduction of perinatal HIV transmission. This project addresses the
new strategies for a changing epidemic developed at the Centers for Disease Control and
Prevention called “Advancing HIV Prevention”: Further decrease perinatal HIV transmission.
B. Background of Advancing HIV Prevention (AHP)
One of the goals of Advancing HIV Prevention, CDC’s recently launched initiative, is to further
decrease perinatal HIV transmission (1). Strategies for accomplishing this goal include (a)
working with prevention partners to disseminate recommendations and support implementation,
(b) providing training for providers and health departments in conducting prenatal testing, (c)
promoting universal prenatal HIV screening according to the opt-out approach (e.g. HIV testing
is part of the routine battery of prenatal tests unless a woman declines), and (d) promoting routine
rapid testing during labor and delivery for women whose HIV status is still unknown. These and
other strategies will be necessary to further reduce perinatal HIV transmission in the United
States.
Progress towards this goal may be measured through surveillance efforts of HIV-exposed infants.
C. History of EPS
In February 1994, the Pediatric AIDS Clinical Trial Group Protocol 076 demonstrated that
zidovudine (ZDV) could reduce the risk of mother-to-child HIV transmission from 25% to 8%
(2). As a result, a United States Public Health Service (USPHS) task force issued
recommendations in August 1994 for the use of ZDV to reduce perinatal HIV transmission.
Included are treatment options for HIV-infected pregnant women and for infants born to HIVinfected women and recommendations for the medical monitoring of pregnant women and of
infants who receive ZDV (3). In July 1995, the USPHS published recommendations for HIV
counseling and voluntary testing for all pregnant women, which include advice to health care
professionals on educating women about the importance of knowing their HIV status and the
steps to preventing mother-to-child transmission (4). Revised recommendations for HIV
screening for pregnant women, which further emphasized HIV testing as a routine part of
prenatal care, including rapid testing during labor and delivery, were published in 2001 (5).
With the emphasis on the importance of preventing perinatal HIV transmission, the CDC
implemented activities targeted at further reducing perinatal transmission of HIV in high
prevalence areas. The Enhanced Perinatal Surveillance (EPS) Project was created as an
extension of routine surveillance activities.
08/16/2006
5 OF 40
D. Purpose and Use of EPS Procedural Guidance
The EPS Procedural Guidance will serve as a standardized approach to the collection,
management, analysis and dissemination of data on HIV-exposed infants in the funded project
sites. CDC provides guidance in the EPS Procedural Guidance to address approaches in
conducting EPS in name-based and code-based sites as well as population and facility-based
sites.
08/16/2006
6 OF 40
II. Goals and Objectives
The goals and objectives of the EPS project are to allow State and local health departments to
evaluate: 1) the impact of implementation of efforts to maximally reduce perinatal HIV
transmission; 2) prevention failures for perinatal HIV transmission; 3) the efficacy of zidovudine
(ZDV) and other antiretroviral medications in preventing perinatal HIV transmission; 4) potential
adverse outcomes of perinatal and postnatal antiretroviral therapy; and 5) the Public Health
Service recommendations for opportunistic infection prophylaxis by:
A. Conducting medical record reviews of mother/infant pairs and longitudinal follow-up of all
HIV exposed children to ascertain: (i) knowledge of maternal HIV infection status before
birth; (ii) HIV incidence; (iii) AIDS incidence; (iv) death; (v) the use of maternal and
neonatal zidovudine (ZDV) and other antiretroviral medications; and (vi) efficacy of these
medications in preventing HIV transmission.
B. Conducting medical record reviews to evaluate recommendations for opportunistic infection
prophylaxis and initiation of HIV evaluation and treatment in children.
C. Assessing potential adverse outcomes of exposure to antiretroviral medications among
infected and uninfected children in the short term (e.g., birth defects, ascertained through
record reviews and registry matches) and in the long term where there is a retention of
records on exposed infants (e.g., by matching to tumor registries).
D. Matching HIV/AIDS registries to birth registries to ensure complete ascertainment of
mother/infant pairs.
E. Collaborating with CDC to track progress towards the maximal reduction of perinatal HIV
transmission.
08/16/2006
7 OF 40
III. Partners in Cooperative Agreement
A. Centers for Disease Control and Prevention (CDC)
The following is the CDC staffing pattern for the EPS Project as of January 2006. All staff
members are located in the National Center for HIV, STD, and TB Prevention (NCHSTP),
Division of HIV/AIDS Prevention:
1. Project Officer
Suzanne Whitmore, DrPH is the CDC Project Officer for EPS. She is responsible for the overall
management of the project and oversees the administrative aspects of EPS.
2. Project Coordinator
Nan Ruffo is the CDC Project Coordinator for EPS. Her duties are to act as liaison for all day-to-day
project issues, provide feedback on issues related to data collection procedures and participate in the
analysis of EPS data.
3. Data Manager
Nan Ruffo is the CDC Data Manager for EPS. She is responsible for all data management
activities including data entry, edit checks, processing follow-ups, corrections and deletions in
the data system, data quality, evaluation and analysis for data dissemination.
4. EPS Analytical Working Group
Tonji Durant, PhD
Lorena Espinoza, DDS, MPH
Alpa Patel-Larson, MPH
Nan Ruffo
Suzanne Whitmore, DrPH
This working group is tasked with developing and analyzing EPS data from all participating
sites.
B. State and Local Health Departments
Record reviews and data abstraction will be conducted by State and local personnel responsible
for HIV/AIDS surveillance activities as deemed appropriate by State, local, and CDC staff.
Although several people at State and local health departments may be involved in perinatal
08/16/2006
8 OF 40
surveillance activities, one individual from each State/local health department will serve as
primary coordinator and contact person for this project.
1. Project Director
The duties and responsibilities of the Project Director:
•
•
•
•
Oversee administration of EPS and supervise staff
Act as liaison with CDC
Assure compliance with the EPS Procedural Guidance
Provide CDC with annual progress reports
2. Pediatric Surveillance Project Coordinator(s)
The duties and responsibilities of the Pediatric Surveillance Coordinator:
•
•
•
•
•
•
•
•
•
•
Primarily responsible for the day- to day activities for EPS
Oversee data collection procedures
Oversee all data management procedures
Train staff and participate in EPS training and meetings
Oversee the development of the procedural guidance’s site-specific sections and data
collection form’s site specific questions
Apply and track Institutional Review Board (IRB) approval and inform IRB of any
changes
Participate in the analysis of EPS data
Prepare and renewal all cooperative agreement applications and annual progress reports
Responsible for maternal and child health linkages with other datasets
Assure quality control of data entry and data collection by conducting process and
outcome evaluation activities
3. Abstractors/Data Entry Staff
The responsibilities for Abstractors include:
1. Conduct medical record reviews and abstraction of data for the EPS Project.
2. Inform the coordinator of EPS data collection activities
3. Assist with operational activities
The responsibilities for Data Entry staff include:
1. Enter EPS data into data entry system
08/16/2006
9 OF 40
4. Community Planning Groups / Prevention Program Partners
The community planning groups and prevention partners will serve to aid in the development of
site-specific questions and advise surveillance staff on the analysis and dissemination of EPS
data. The Surveillance Coordinator should provide updates the community planning groups and
prevention partners at least once a year.
08/16/2006
10 OF 40
IV. Methods
A. Project Design
This project constitutes an integrated HIV/AIDS population-based or facility-based
surveillance system for HIV-infected mothers and their perinatally exposed children. Data
will be collected using both the HIV/AIDS case report form and the supplemental EPS
abstraction form (Appendix A). HARS records will be updated on an ongoing basis as needed.
The data to be collected include: maternal prenatal care usage, maternal HIV test history,
prenatal and neonatal antiretroviral therapy, other interventions to prevent transmission,
receipt of prophylaxis and treatment by the infant, appropriate follow-up care of the mother
and child, and other interventions relevant to the evaluation of recommended public health
actions to prevent perinatal HIV transmission.
Enhanced perinatal surveillance constitutes additional case ascertainment methods, linking of
mother-infant pairs and review of supplemental medical records. Supplemental medical
record reviews will include both the mother’s and child’s medical records (mother’s HIV
clinic chart, prenatal records, labor and delivery records, newborn hospital and pediatric clinic
charts, birth and death certificates, and laboratory reports) to assess testing, prenatal care, and
treatment, longitudinal follow-up to assess infection status of infants, initiation of HIV-related
care, and long-term outcomes. States without named HIV infection reporting may have
authority (based on Institutional Review Board (IRB) assurance, relevant State public health
laws, statutes, rules, etc.) to access HIV-infected mother’s and HIV-exposed infant’s medical
records at medical facilities and to collect data from these records.. The specific methods for
collecting data on HIV-infected mothers and their HIV-exposed infants will vary depending
on the HIV reporting laws and policies of each State. Unless prohibited by reporting laws or
regulations, matching HIV/AIDS and birth registries will be conducted to help ensure that all
mother/infant pairs are identified and the data are representative of all HIV-infected pregnant
women. Where feasible, additional registry matches (i.e. birth defects and tumor registries)
will be conducted to assess potential adverse outcomes of antiretroviral exposure among
infected and uninfected children in the short and long term.
The HIV-exposed infants identified through enhanced perinatal surveillance will be followed
up by the health department every 6 months for up to 18 months until their HIV infection
status is determined, and, if they meet the HIV/AIDS case definition, will continue to be
followed to determine their vital status. At each six month interval, HARS (the HIV/AIDS
surveillance software reporting system) will be updated with new information. Children
found to be HIV-uninfected will be maintained in HARS as a perinatal exposure (unless
prohibited by State law).
08/16/2006
11 OF 40
B. Project Sites
Applicants funded for the Enhanced Surveillance for Perinatal Prevention Project in 2006 are:
Chicago; Connecticut; Delaware; Georgia; Houston; Los Angeles; Louisiana; Maryland; New
Jersey; New York; New York City; Philadelphia; Puerto Rico; South Carolina; and Texas, or
their bona fide agents.
1. HIV Exposure Reporting
CDC and the Council of State and Territorial Epidemiologists (CSTE) recommend that all states
and territories conduct surveillance for perinatal HIV exposure with follow-up to determine HIVinfection status of the infant and progression to AIDS (6-8). Sites should conduct populationbased perinatal HIV exposure surveillance for infants born to HIV infected mothers and follow
the infants until 18 months of age or until status is determined. Refer to Appendix B for
Technical Guidance for HIV/AIDS Surveillance Programs: Pediatric HIV/AIDS Case Reporting.
Perinatal exposure reporting differs from reporting of pediatric cases of HIV among children <13
years of age, as exposed infants may or may not be infected with HIV. Antibody tests may be
positive at birth regardless of the infant’s true HIV status due to the transplacental transfer of
maternal antibodies. Common ways that mother-infant pairs are often identified include active
HIV/AIDS case finding, reports of HIV-infected pregnant women to surveillance, reports of
HIV-exposed or HIV-infected infants to surveillance, birth registry linkages (e.g. programs can
match HIV cases in women of child-bearing age with the birth registry database annually), and
hospital discharge summaries.
The specific methods for collecting data on HIV-infected mothers and their HIV-exposed infants
will vary depending on the HIV reporting laws and policies of each State. Sites that have HIV
exposure reporting laws have the authority (based on relevant State public health laws, statutes,
rules, etc) to access HIV-infected mothers’ and HIV-exposed infants’ medical records and to
collect data from these records to be stored at the State/local health department.
2. Non-HIV Exposure Reporting
States without HIV exposure reporting will be able to access HIV-infected mothers’ and
HIV-exposed infants’ medical records and to collect data from these records, based on separate
IRB assurance. The specific methods for collecting data on HIV-infected mothers and their
HIV-exposed infants will vary depending on the HIV reporting laws and policies of each State.
Unless prohibited by reporting laws or regulations, matching HIV/AIDS and birth registries will
be conducted to help ensure that all mother/infant pairs are identified and the data are
representative of all HIV-infected pregnant women.
08/16/2006
12 OF 40
C. Case Eligibility/Ascertainment
1. Cohort Birth Year
All project areas should collect data on HIV-exposed infants (and their mothers) born in 20052008. Data for these birth years previously abstracted on the January 2003 EPS abstraction form
will be updated using the 2006 EPS abstraction form to obtain data collected exclusively on the
new form.
2. State/City of Birth Hospital v. State/City of Residence
Case eligibility will be determined by the site. If the site is facility-based, the EPS data
abstraction form will be completed on all infants identified in the selected facilities. If the site is
population-based, the EPS data abstraction form will be completed for all infants born within the
project area. In these instances, sites in which the birth occurred should coordinate abstraction
efforts with the project site of residence to obtain all needed data. For states with a separately
funded city, case eligibility will be based on case ownership established through core HIV/AIDS
surveillance activities.
3. Eligible Mother-Infant Pairs
Mother-infant pairs meeting any of the following criteria are eligible for inclusion in EPS:
a. Women who were known to be HIV-infected in pregnancy (tested before or at
delivery) and delivered in the data collection birth years
b. Women who were not known to be HIV-infected in pregnancy, but whose child was
reported to surveillance (either as indeterminate, infected, or seroreverter) and was
born in the data collection birth years
c. All children reported to surveillance who were born to HIV-infected mothers and
were born in the data collection birth years.
4. Case Ascertainment
In HIV exposure reporting sites, ascertainment of mother-infant pairs will consist of all infants
born to HIV-infected mothers within the geographic area defined by the project. These sites will
conduct the project as though it is part of core surveillance activities. See Appendix B
Project sites without HIV exposure reporting will conduct these activities in selected facilities
serving large numbers of HIV-infected women (e.g., delivery hospitals or high-risk prenatal
clinics) and HIV exposed children (e.g., specialty pediatric clinics, pediatric HIV clinics).
Thought should also be given as to whether other facilities and certain sites conducting
prevention activities should also be targeted. Mother-infant pairs will consist of all HIV-exposed
infants born to HIV-infected mothers within these selected facilities in the geographic area
defined by the project. In addition, these sites will need to complete the following:
a. Must obtain State and facility IRB approvals
08/16/2006
13 OF 40
b. Must submit IRB approved protocols to CDC. Procedural Guidance should include
how facilities were chosen for inclusion and a timeline for the project.
c.
5. Case Finding
EPS project staff should identify report sources including HARS, laboratory reports, birth
certificates, death certificates, and case management records. Ascertainment of mother-infant
pairs should occur through both active and passive surveillance.
a. Active surveillance
EPS project staff should regularly contact reporting facilities or have an active reporting system
established with delivery hospitals and clinics to identify potential/suspect HIV/AIDS perinatal
exposure cases. HIV-infected women should be identified during pregnancy by surveillance staff
and the infant should be investigated until the infection status is known.
b. Passive surveillance
Reporting systems with laboratories, pediatric clinics, and HIV clinics should be established to
receive testing results on exposed infants, including all positive and negative polymerase chain
reaction tests.
6. Vital Statistics Birth Registry Match
A registry match between the HIV/AIDS registry and the birth registries is critical for
ascertaining all possible mother/infant pairs so that data is representative of all HIV-infected
pregnant women who were known to be HIV-infected during pregnancy. A registry match
occurs when a woman’s information on the HIV/AIDS registry matches the maternal information
on the infant’s birth certificate.
7. Other Methods of Case Ascertainment
08/16/2006
14 OF 40
D. Data Collection
1. Data Sources
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
Prenatal care records
Maternal HIV clinic records
Labor and delivery records
Pediatric birth records
Pediatric HIV medical records
Pediatric medical records (non-HIV clinic/provider)
Birth certificate
Death certificate
Health department records
Other records
2. Data Collection Instruments
a. Historical changes to data collection form
The EPS data collection form has been revised based on information availability and reliability in
the medical records. It was also revised to better collect data of interest and to improve analysis
capacity. For information on what and how information should be abstracted, refer to Appendix
C (EPS User’s Guide).
b. Integration with HARS case reports
The EPS abstraction form will be completed for every mother/infant pair in addition to the
HARS case report forms. Every infant included in the Enhanced Perinatal Surveillance system
must have a State of report and a State number. These two pieces of information are required for
inclusion in the EPS data entry system. If the project site is code-based, a project ID number will
be established in place of the code. No coded ID numbers will be sent to the CDC.
Both the HARS case report form and EPS form should be abstracted at the same time. If a
HARS report already exists within the system, EPS variables collected on the HARS case report
form should be re-abstracted to assure accuracy. Any discrepancy should be addressed in the
HARS database.
c. Abstracting data from medical records
Data will be collected from various reporting sources including health care providers, hospitals
and clinics, laboratories, and vital statistics records (birth and death certificates). Medical
records that will be accessed to complete the HIV/AIDS case report form and the supplemental
data collection form include those listed in the above Data Sources section. All pediatric medical
records should be reviewed six weeks postpartum or later so that data on neonatal antiretroviral
08/16/2006
15 OF 40
use, breastfeeding, etc. will be available. However, timely collection of these data is essential for
identification of missed prevention opportunities, and targeting of prevention activities.
The standard pediatric surveillance case report form includes data on mother’s HIV status;
demographic and risk factors; the timing of the mother’s HIV test with respect to the child’s
birth; the timing of first prenatal care visit and the total number of visits; use of ZDV to prevent
transmission (prenatal, intrapartum, and neonatal); mother’s use of other antiretrovirals; type of
delivery; use of PCP prophylaxis in child and date started; use of antiretrovirals for treatment for
child and date started; breast feeding; birth defects; vital status; child’s primary medical
reimbursement provider; and the type of care in which the child has been enrolled.
The supplemental data abstraction form will collect more specific and additional data on timing
and receipt of prenatal care; HIV diagnostic testing history; illicit drug use and STD history
during pregnancy; immunologic testing; and clinical status. The form will also collect
information on receipt of ZDV and other antiretroviral agents by the woman during pregnancy;
labor and delivery; and receipt of antiretrovirals by the newborn. Information on mode of
delivery; determination of the HIV status of infant; receipt of prophylaxis and treatment by the
infant; breast feeding; birth defects; and assessing follow-up care of the mother and child is also
collected. It is also important to know if documentation of mother’s HIV status is found in labor
and delivery records and in the infant’s medical record.
The pediatric HIV/AIDS case report form and the supplemental data abstraction form will be
completed for each child. A woman may give birth more than once over the abstraction period.
For such women, each pregnancy should be abstracted on a separate form. The maternal
information pertinent to each pregnancy must be included. If a woman has twins or triplets, a
separate data abstraction form should be completed for each infant. Once data are entered in the
HARS and EPS systems, these data should be merged and selected variables will be sent to the
CDC EPS data manager.
d. Site-specific questions
States have the opportunity to supplement the standard questions with questions that address
additional issues of particular importance for their individual site. Site-specific questions are
developed and pre-tested by the site, and are incorporated into the site-specific portion of the
abstraction form. These questions will be entered into the EPS data entry system using the
variable names SSQ1 – SSQ10. Sites will submit site-specific questions to the CDC for approval
prior to data collection. Refer to Appendix D for site-specific questions.
3. Data Collection Procedures
a. Timing of collection
Abstraction forms should be completed as the mother-infant pairs are identified and in
accordance with the sites’ core surveillance procedures. Minimum timeliness standard of ≥ 66%
08/16/2006
16 OF 40
of cases for a diagnosis year are reported within 6 months of diagnosis, assessed at ≥ 85%
completeness 12 months after the diagnosis year.
For detailed guidance on timeliness of reporting refer to Appendix E (Technical Guidance for
HIV/AIDS Surveillance Programs: Access to Source Data and Completeness of Reporting).
b. Attainment of records
c. Completeness of reporting
Completeness of HIV/AIDS case ascertainment can be calculated by comparing the number of
cases diagnosed and reported to the surveillance program for a diagnosis year with the number of
cases expected to be diagnosed during that year.
Completeness can be assessed for cases that meet the project requirements. Checks on case
ascertainment include:
• Case-finding audits
• Capture-recapture analyses
• Regular assessments of reported vs. expected number of cases received from a reporting
source, e.g., electronic lab reporting (determine frequency at least quarterly), with
feedback to the reporting source. Possible data sources include state based Survey of
Childbearing Women data, laboratory reporting data, AIDS Drug Assistance Program,
and Medicaid.
Completeness of case ascertainment for a diagnosis year is measured at 12 months after the
diagnosis year, comparing the number of cases diagnosed and reported to the surveillance system
for a given year to the number of cases expected to be diagnosed during that year. The standards
for completeness are
• Minimum performance standard: ≥ 85% of expected number of cases for a diagnosis year
are reported by 12 months after the diagnosis year.
• Target performance standard: ≥ 95% of expected number of cases for a diagnosis year are
reported by 12 months after the diagnosis year.
For detailed guidance on completeness of reporting refer to Appendix E (Technical Guidance for
HIV/AIDS Surveillance Programs: Access to Source Data and Completeness of Reporting).
d. Notation of abstraction procedures & anomalies
e. Follow-up of children
All infants and children born to HIV-infected mothers, including perinatally-exposed and
infected children, reported to surveillance will be followed up at 6-month intervals. According to
08/16/2006
17 OF 40
routine pediatric surveillance guidelines (Appendix B), infants are followed to document the
following events: i) confirmation of infection or seroreversion; ii) referral to appropriate clinical
follow-up and receipt of drug therapies; iii) onset of AIDS; and iv) confirmation of vital status.
Children should be followed until they are determined to be uninfected or until they reach 18
months of age.
The uninfected children should remain in the HARS database. If HIV exposures are not
reportable, a HARS database separate from that which maintains case reports on HIV-infected
persons could be established. These HIV-exposure registries should be maintained in accordance
with State laws. They are essential for follow-up and investigating outcome measure related to
exposure to antiretroviral drugs. If consideration is being given to delete these HIV-uninfected
children from the database, prompt notification to CDC should be made before any deletions
occur.
A proposal to revise the pediatric HIV surveillance case definition was approved by the CSTE in
2006 (9). These new criteria should be used in determining the child’s HIV infection status. All
AIDS diagnoses should be reported in accordance with the 1987 pediatric AIDS case definition
(10). The clinical guidelines for Pneumocystis pneumonia (PCP) prophylaxis for children (11)
and the use of antiretroviral agents for pediatric HIV infection (12) may also be used as a
reference when conducting follow-up activities.
E. Data Management (Electronic Data Entry & Transfer)
A web-based data entry system is currently being developed. This system will allow project sites
the ability to enter their own data at the site level thus making the data more readily available for
ongoing prevention and care planning. All data will be reported to CDC in a secure manner
using CDC-provided forms and software.
1. Structural Requirements
The structural requirements for data management include hardware and software that allow
searching for existing cases, importing of data and linkage to other databases, transmission of
data, data quality functions, and report generation in a secure environment. Further, staff must
receive adequate training (initial training and continuing education) in data processing to assure
consistency.
2. Process Standards
The processes for data management must be documented in procedures manuals and kept up-todate to maintain an adequately functioning system and to train staff. The documentation may
include manuals for the data entry software as well as documentation of processes specific to the
local health department.
08/16/2006
18 OF 40
a. Data entry
Paper documents received by EPS Coordinators or other designated EPS staff should be marked
with the date of receipt and, after visual editing (proofreading), data items from these documents
should be entered into the EPS software. Local programs should develop written procedures for
handling and storage of paper and electronic documents, including an acceptable time frame
from document receipt to data entry. Some verification of keyed data should be in place, such as
duplicate data entry to compare original and duplicate documents for discrepancies (See Data
Quality).
b. Edits
Data edits are automatically applied when information is entered into the system and are applied
to all data on a routine schedule (See Data Quality). The edits are described in the EPS software
documentation. Each document should be retained as originally received. If data edits indicate
incorrect information in a particular document, EPS staff should verify that the information was
correct as indicated by the source records. However, information in a document should not be
changed based on information from other medical records. The rules for abstracting multiple
records described in the User’s Guide should be applied to select the best value for a data
element, or to override information from a document that is proven to be incorrect (Appendix C).
c. Processing follow-ups, corrections, and deletions
In many instances, follow-up is required to obtain all necessary information on a case.
Information obtained from a source during follow-up for missing information on a case may
range from one particular data item (e.g., risk factor information) to many data items; this
information is recorded on a new EPS data abstraction form if the follow-up information is
obtained after the case has been entered into the EPS software. If the follow-up is prior to data
entry, the additional information may be recorded on the original form. When information is
gathered on a new EPS form during a follow-up investigation, this form must be marked as a
follow-up report; this information is also entered into the EPS software.
In some instances, information is found to be incorrect (e.g., a data edit revealed an invalid value
and the report source is re-contacted or re-visited and the correct information is obtained). Then
the information should be corrected on paper and electronic forms. Changes to original
documents should only occur if verification is obtained. If information is incorrect on a
document but known to be correct based on information obtained through another medical
record, staff can correct the original form if not previously entered into the EPS software. If case
has been entered into the EPS software, the correct value and infant identifiers should be written
on a new EPS form for data entry updates. Any errors created during data entry should be
corrected in the software.
Cases may also need to be deleted after they have been entered into the EPS software (for
example, infant is found to have a duplicate record). After a document or record for an infant is
marked for deletion and the updated information is sent to CDC, final deletion occurs after
feedback from CDC is received that the case deletion was noted and was also deleted in the
08/16/2006
19 OF 40
national database. Paper forms should also be marked as deleted with the reason for deletion in
the software.
d. Documentation
Data management processes—data collection, additions, changes, deletions, and the like—should
be documented, including the staff performing the action, the date, and the action (e.g., changed
sex from male to female). In addition, data management reports should be routinely created and
shared with the appropriate parties. Such reports include:
•
•
•
•
Reports of database and surveillance operations (e.g., staff access to data,
changes/deletions, workflow [e.g., cases by process completed such as visual editing,
follow-up investigations], and listing of cases missing critical data items)
Reports of cases reported
Reports of timeliness and completeness of reporting to provide feedback to data
abstractors
Reports on quality control operations (See Data Quality)
Comment [n1]: Would like to be able
to include these types of reports, but we
currently don’t know if the system will
allow for these. I will update the
guidance once the system is in place.
3. Data Files
4. Data Analysis Files
5. Data Management Procedures
a. System backup
b. Computer virus protection
c. Quality control
d. Security and access to abstractions and computer files
Comment [n2]: Need system
information to complete these sections.
e. Quarterly report generation
08/16/2006
20 OF 40
F. Data Quality
1. Structural Requirements
a. Procedure manuals, coding manuals, and other documentation
The surveillance program must document all procedures, coding of information, and data edits,
and this documentation must be available to all staff. The documentation must be aligned with
the policies and standards for CDC’s HIV/AIDS Reporting System. This documentation should
also include the site’s quality assurance plan (checks on case ascertainment and checks on data
quality), staff training, and quality control activities.
b. Edits and data processing
Computerized data edits that check for item validity and internal consistency based on logic rules
are generally part of the EPS software. At a minimum, the standard data edit checks must be
available (the edits are described in the EPS software documentation). Information from edit
procedures should be retained and analyzed on a regular basis to detect and correct problems
with specific data sources, abstractors, or instruction manuals.
The software system should allow duplicate data entry and the preparation of reports comparing
the original and duplicate entry.
The EPS software system should allow a sample of records to be selected for audits or special
studies. In addition, the system should allow original data to be compared with data from reabstraction studies. Either through built-in functions of the EPS software, or through other
analytic packages, quality control personnel must be able to produce reports to measure data
quality standards. Standard methods must be used to produce the outcome measures.
2. Process Standards
a. Adherence to data standards
Data items should be collected according to standard codes as defined in the EPS User’s Guide
(Appendix C). Using standard codes allows data exchange between local sites and aggregation of
data on the national level. Adherence to standard codes is assessed with standard data edits.
b. Training
Training is an essential component to assuring accurate, consistent, and complete data collection.
Training for registry staff should include:
• Reporting requirements, including frequency of reporting, mechanism of reporting, and
required data items
• Data collection, including reportable events, case-finding procedures, coding, and followup procedures
08/16/2006
21 OF 40
Comment [n3]: Again, we don’t
know if this will be allowed in the new
system.
•
•
Quality control, including visual and computer edits and feedback regarding edit results
Data processing, including data entry
c. Quality control activities
The quality control activities described in this section primarily address the accuracy of the data
collected. Checks on case ascertainment (accuracy of case counts, completeness of reporting)
and timeliness of case reporting are described in Data Collection Procedures.
Data quality control activities include:
• Visual editing (proofreading) of hard copy case report forms (all forms, all data items,
and all comments) before data entry, if possible by a person other than the person
completing the form. This includes checking readability, consistency, and coding, and
verifying any inconsistent or unclear responses.
• Duplicate data entry (all or at least 10% of hard copy forms). An alternative option is to
select 10% - 20% of cases and cross-reference them with the hard copy. Any
discrepancies identified in reports of the results from duplicate data entry (i.e., the
comparisons of the original and duplicate documents) should be resolved, and the results
should guide training efforts regarding data entry.
• Electronic edit checks of the consolidated case-based records (all standard data edits
[SAS program will be provided by CDC] are applied to all records before data transfers to
CDC, but at least quarterly), and resolution of errors.
• Duplicate abstracting (Appendix F).
• Data analysis and use: Inconsistencies in the data are often discovered during data
analyses. These problems should be communicated to the quality control staff for followup and improvements of procedures.
d. Outcome measures
The validity and accuracy of estimates derived from individual data elements may be limited if
these data elements contain errors or a large proportion of information is missing or unknown for
them. Standards for individual data elements are measured by edits (proper values, internal
consistency), the percentage of missing information, and re-abstraction studies.
Outcome standards are set to indicate the minimum at which data can be reliably used for
analyses and should be assessed for each diagnosis year at the specified time for all cases
meeting the HIV/AIDS case definitions. The results should be used to improve surveillance
processes.
•
•
Edits: The minimum standard for passing data edits is that ≥ 97% of case records pass all
standard data edits. The target standard is that 100% of case records pass all standard
data edits. The edits for the standard include those variables most important for data
analysis. The standard is assessed for the most recent diagnosis year at 12 months after
that diagnosis year.
Missing/Unknown Information: The proportion of case records missing information is
assessed for infant’s soundex, mother’s date of birth, mother’s race/ethnicity, receipt of
08/16/2006
22 OF 40
prenatal care, antiretroviral therapy during pregnancy, labor/delivery, and neonatal
period, timing of maternal HIV testing, mother’s most advanced disease classification
during pregnancy, infant’s HIV infection status, type of birth, delivery method, birth
weight, receipt of PCP prophylaxis, and infant’s date of death (for those known to be
dead). The target is 0% missing information.
Note: Percentage of missing information is measured for each data item at 12 months after
the diagnosis year. While a code of “unknown” or “indeterminate” is not the same as a code
for missing value, the percentage of “unknown” or “indeterminate” is also calculated. A
separate standard addresses missing information for mother’s transmission category.
• Re-abstraction Studies: Agreement rates are calculated from re-abstraction studies as an
indicator of data quality. No standards have been set for agreement rates.
G. Data Analysis
Data analysis will occur both at the project site (i.e., the State and/or city health department) and
on a national level at CDC. Results will be disseminated through standardized reports,
Supplemental HIV/AIDS Surveillance Reports (CDC), MMWR publications, professional
peer-reviewed journals, and at appropriate meetings and conferences. These data will be made
available for timely use by prevention partners for planning, targeting, and evaluation purposes.
Data can also be used to assess and evaluate guideline implementation, quality control of data,
and progress on Advancing HIV Prevention goals of decreasing perinatal transmission in the
U.S.
1. Preparation for Analysis
a. Data complete for analysis
Sites should use the variable ‘Information Complete for Analysis’ found on the EPS data
collection form to determine whether or not a case should be included in the analysis dataset.
The response should be given based on the definition of completeness defined by the EPS
Coordinator, Surveillance Coordinator, or another designee. Sites should use the following
guidelines to help determine if the data are ready for analysis:
1. 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.
2. Information through the birth history should have been obtained.
3. Completeness should be judged based on what information is abstracted that is most
useful to the site in performing any particular analysis.
Sites should create a definition incorporating these guidelines and use it consistently for all
analyses during the project period.
08/16/2006
23 OF 40
b. Data accuracy
As described in Data Quality, edit checks for item validity and standard edits for all case-based
data will be applied to the dataset being used for each analysis. This will ensure data accuracy
across all analyses within the site and across the project sites for national level analyses.
c. Security and confidentiality
Analysis databases or datasets that are released to individuals who work outside the secured area
must be held securely until the data are approved for release. For example, health department
epidemiologists or statisticians who do not work in the secured area often use analysis databases
for routine analysis. The computers used in these circumstances must have protective software
(e.g., user ID and password protection) to maintain data securely. Other robust authentication
methods also may be used since the examples described are only the minimum required.
Encryption software is not required with analysis databases because they are considered much
less sensitive than those that contain names or other personal identifiers. Analysis data are still
considered sensitive, since it may be possible to identify individuals by using particular
combinations of reporting system variables. For that reason, analysis data should not be taken
home, and all the results of all analyses performed by using reporting system variables must be
approved for release as outlined in the surveillance unit's data release policy.
If the occasion should arise that it is necessary to include identifying information in a dataset, the
EPS Coordinator should refer to the Access Control section in the Technical Guidance for
HIV/AIDS Surveillance Programs, Volume III: Security and Confidentiality Guidelines (13).
2. Site-Specific Analyses
At the beginning of the project period, sites should define their specific data needs and how EPS
data will be analyzed to meet these needs. A Site-specific analysis plan should be developed to
use as a guide for planning and conducting all analyses using EPS data. As data needs change,
this plan can be modified to meet these changes.
The Site plan should cover these basic areas:
• A list of data needs for the site for the three-year project period. Data needs include data
for funding requests, health department policy changes, legislative requirements, needs
assessments, prevention and care program needs, and process monitoring. Sites should
collaborate with prevention program staff to establish local data needs.
• A list of EPS questions that would be used to address the data needs
• A listing of proposed analyses as well as a rationale and plan for dissemination
• A policy for review of reports, manuscripts, and presentations
• A policy for access to data by external researchers. External researchers are persons not
part of the state/local health department research team.
• A policy on authorship.
08/16/2006
24 OF 40
•
•
A list of individuals from the state/local health department who will be analyzing EPS
data
A timeline for completing the data analyses
EPS sites should also provide CDC with final copies of any major presentations and publications
written by state/local EPS staff or external researchers. Examples include presentations at major
external conferences (e.g. National HIV/AIDS conference), major internal meetings (e.g.
state/local planning groups), and journal articles.
4. National/CDC Analyses
CDC is responsible for descriptive and analytic studies using aggregated data. CDC will obtain
written permission from the individual EPS project sites when plans are made to conduct any
analyses that will identify specific sites. Types of CDC analyses include periodic surveillance
reports, descriptive and analytic studies using aggregated data for publication in journals or
presentation at national meeting, descriptive articles for MMWRs, and analyses of EPS
methodology.
H. Dissemination of Results
The dissemination of EPS data is essential to a successful surveillance system. For data to be
used effectively for prevention and care needs, they must be disseminated effectively.
1. Ways to Use EPS Data
Ways to use EPS data include:
• Evaluating care and prevention strategies and programs
• Monitoring progress toward state and local health objectives
• Supporting legislation
• Assessing needs
• Informing care and prevention programs/community planning groups
• Developing or modifying prevention and care programs
• Linking EPS data to other maternal and child health data sources
2. Ways to Disseminate EPS Data (Past, Present, Future)
Ways to disseminate EPS data include:
• Presentations at national and state/local conferences and community planning group
meetings
• Publications (abstracts, manuscripts) and reports in national and state/local journals and
in the MMWR
08/16/2006
25 OF 40
•
•
•
•
•
•
•
•
Website posting of data
Fact sheets
Media messages
Local newsletters using mailing lists of data users, program planners, health care
professionals, and state/local provider associations.
Epidemiologic profiles/Perinatal Epidemiologic profiles
HIV/AIDS Surveillance Summaries
Slide sets
Data requests for Title IV and V grants of the Ryan White CARE Act
3. Authorship Principles with CDC, Partners & External Researchers
Sites should establish written authorship principles in accordance with their state/health
department guidelines on authorship. CDC has established some guiding principles for CDC
authors. For further information on CDC Authorship Guidelines:
http://www.cdc.gov/od/foia/policies/author.htm
Authorship issues need to be addressed prior to data analysis. An individual involved in this
process should be recognized as an author or be identified in the acknowledgement section of the
publication. The minimum basis for authorship requires participation in the following:
•
•
•
The conception or design, data collection, and/or data analysis and interpretation of data
Drafting the manuscript or reviewing/revising critical sections
Assume responsibility for the final version of the manuscript
Authors must be an active participant in the planning, writing, and reviewing of the publication
as well as publicly defend the project if such need occurs. Authors should also be decided upon
and put into writing during the planning stages of the publication. The first author is the
individual that writes the first draft of the paper and coordinates the writing and editing
processes. Secondary authors should be listed in order of their contribution to the publication.
No one should be listed as an author without his or her knowledge and consent. Persons that
make contributions to the publication or participate in EPS but do not meet the criteria for
authorship can be included in the acknowledgement section of the publication.
For publications where CDC persons collaborated with state/local groups, that individual should
be listed in the authorship line. If there is no CDC author, please include an acknowledgement to
the “Centers for Disease Control and Prevention.”
For state/local publications, recipients should place an acknowledgement of Public Health
Support (PHS) for recipients of this funding: This publication was made possible by grant
number PS-06-607 from the Centers for Disease Control and Prevention.”
For publications where external researchers have contributed to the publication, the individual
should be listed in the authorship line.
08/16/2006
26 OF 40
4. Review of Abstracts and Manuscripts
If CDC personnel are listed in the authorship line, publications must undergo a minimum
clearance process through the CDC division level. Please allow a minimum time frame of at least
four weeks for clearance processes.
I. Limitations of EPS Data
Data collected as part of the EPS project may not be representative of all HIV-exposed infants in
each site, since unreported cases of HIV-infected mothers are not abstracted. Some sites are able
to collect data at the population-level; however, some sites are only able to obtain IRB approval
from a certain group of facilities in the specified geographic area serving high-risk populations.
In addition, data linkages for case identification may be different for code-based reporting sites
compared to name-based reporting sites.
Completeness of reporting ascertained by using the 1994 Survey of Childbearing Women (or
later if sites used local budgets to conduct a serosurvey) may under- or overestimate the number
of births to HIV infected women. For further information, refer to the Completeness of
Reporting section of this document. For antiretroviral treatment, EPS data cannot ascertain
compliance with prescribed regimens and can only note what was prescribed.
08/16/2006
27 OF 40
V. Project Time Line
Start-up
December 21, 2005 – Program announcement
February 13, 2006 – Application deadline
March 1, 2006 – Objective review panel
April-May 2006 – Funding decision made
June/July 2006 – Approval of data abstraction form, CDC and site-specific procedural guidance;
Approval by site-specific IRB, if needed
June 2006- EPS Start-up meeting
July 2006 – Start-up for collecting 2005 data (abstraction, entry & transfer)
A. Ongoing Activities
Conference Calls: Bi-monthly
Updated procedural guidance: Annual basis
Data entry quality controls: Prior to every data transfer
Data transfer on secure data-network: Monthly
08/16/2006
28 OF 40
VI. Protection of Human Subjects
A. IRB Approval
This project has been exempt from CDC IRB review because the activity is not research but
constitutes data collection for the purposes of disease surveillance and program evaluation
(Appendix G). Individual project areas may need local IRB approvals (See Appendix H for an
example). Sites with code-based reporting will need separate IRB approval with each facility. In
addition, some sites may need IRB approval depending on local/state reporting laws that affect
the collection of protected data.
B. Informed Consent
No informed consent is needed for this enhanced surveillance activity. For this project, data are
abstracted from existing medical and ancillary records. There will be no contact with individual
patients. However, grantees must forward to the Surveillance Branch, DHAP-SE, NCHSTP
written documentation of their authority to access HIV-infected mother’s and HIV-exposed
infant’s medical records and to collect data from these records (i.e., HIV reporting laws, IRB
assurance, relevant State public health laws, statues, rules) (Appendix G).
C. Protecting Privacy of EPS Data (Confidentiality and HIPAA)
Provisions for protecting the security and confidentiality of information collected for this project
will be the same as that provided for standard HIV/AIDS surveillance (13). HIV/AIDS case
surveillance data are currently collected under an assurance of confidentiality under Sections 306
and 308(d)of the Public Health Service Act (42 U. S. C. Sections 242k and 242m(d)).
Information collected in HIV/AIDS surveillance system that would permit identification of any
individual is collected with a guarantee that it will be held in strict confidence, will be used only
for purposes stated in the assurance, and will not otherwise be disclosed or released without the
consent of the individual in accordance with Section 306 and 308 (d) of the Public Service Act.
Data for this project (including data on HIV perinatally exposed children) will be collected as
part of routine surveillance and will be covered by existing Assurance of Confidentiality
(Appendix I).
In addition to the assurance of confidentiality, additional protections include physical security of
files and computer safeguards. The CDC security and confidentiality standards for the protection
of HIV/AIDS data have been published in the Technical Guidance for HIV/AIDS Surveillance
Programs, Volume III: Security and Confidentiality Guidelines. Data will be collected by trained
health department personnel. No personally identifying information will be transmitted to CDC,
and all data will be transmitted to the CDC as an encrypted file through the Secure Data
Network.
08/16/2006
29 OF 40
References
1. CDC. Advancing HIV Prevention: new strategies for a changing epidemic—United States,
2003. MMWR 2003;52(No. 15):329–332.
2. Connor EM, Sperling RS, Gelber R, et al. Reduction of maternal-infant transmission of
human immunodeficiency virus type 1 with zidovudine treatment. N Engl J Med
1994;331:1173–1180.
3. CDC. Recommendations of the U.S. Public Health Service Task Force on the use of
zidovudine to reduce perinatal transmission of human immunodeficiency virus. MMWR
1994;43(No. RR-11):1–20.
4. CDC. U.S. Public Health Service recommendations for human immunodeficiency virus
counseling and voluntary testing for pregnant women. MMWR 1995;44(No. RR-7):1–15.
5. CDC. Revised guidelines for HIV counseling, testing, and referral and revised
recommendations for HIV screening of pregnant women. MMWR 2001;50(No. RR-19):59–
85.
6. CDC. Guidelines for national human immunodeficiency virus case surveillance, including
monitoring for human immunodeficiency virus infection and acquired immunodeficiency
syndrome. MMWR 1999; 48(RR-13): 1–31.
7. Council of State and Territorial Epidemiologists. CSTE position statement ID-6: pediatric
HIV infection -- addition to the National Public Health Surveillance System (NPHSS); 1995.
8. Council of State and Territorial Epidemiologists. CSTE position statement ID-4: surveillance
for perinatal HIV exposure; 2002.
9. Council of State and Territorial Epidemiologists. CSTE position statement ID-1: Revision of
the Surveillance Case Definition for HIV Infection Among Children age < 18 months; 2006
10. CDC. Current trends: classification system for human immunodeficiency virus (HIV)
infection in children under 13 years of age. MMWR 1987;36:225–230.
11. CDC. Revised guidelines for prophylaxis against Pneumocystis carinii pneumonia for
children infected with or perinatally exposed to human immunodeficiency virus, MMWR
1995;44[No. RR-4]:1–11
12. Working Group on Antiretroviral Therapy and Medical Management of HIV-Infected
Children. Last revised November 3, 2005. Guidelines for the Use of Antiretroviral Agents of
Pediatric HIV Infection. (http://aidsinfo.nih.gov/ContentFiles/PediatricGuidelines.pdf).
08/16/2006
30 OF 40
13. Centers for Disease Control and Prevention and Council of State and Territorial
Epidemiologists. Technical Guidance for HIV/AIDS Surveillance Programs, Volume III:
Security and Confidentiality Guidelines. Atlanta, Georgia: Centers for Disease Control and
Prevention; 2006.
08/16/2006
31 OF 40
APPENDIX A
EPS Supplemental Medical Record Abstraction Form
08/16/2006
32 OF 40
APPENDIX B
Technical Guidance for HIV/AIDS Surveillance Programs: Pediatric
HIV/AIDS Case Reporting
08/16/2006
33 OF 40
APPENDIX C
EPS User’s Guide
08/16/2006
34 OF 40
APPENDIX D
Site-Specific Questions
08/16/2006
35 OF 40
APPENDIX E
Technical Guidance of HIV/AIDS Surveillance Programs: Access to
Source Data and Completeness of Reporting
08/16/2006
36 OF 40
APPENDIX F
Technical Guidance of HIV/AIDS Surveillance Programs: Data Quality
08/16/2006
37 OF 40
APPENDIX G
NCHSTP Determination of Applicability of Human Subjects
Regulations
08/16/2006
38 OF 40
APPENDIX H
Example from New York City - IRB approval for Site Specific
Surveillance of Mother/Infant Pairs
08/16/2006
39 OF 40
APPENDIX I
Assurance of Confidentiality
08/16/2006
40 OF 40
| File Type | application/pdf |
| File Title | Microsoft Word - Document3 |
| Author | pas3 |
| File Modified | 2006-11-08 |
| File Created | 2006-11-01 |