Attachment 4(a)
National HIV Surveillance System (NHSS)
OMB # 0920-0573
Adult HIV Confidential Case Report Form Technical Guidance
29 October 2012
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Technical Guidance for
HIV Surveillance
Programs
Adult HIV Confidential Case
Report Form
HIV Incidence and Case Surveillance Branch
Atlanta, Georgia
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Contents — Adult HIV Confidential Case Report
Instructions for Completion.................................................................................. 1-3
Purpose of case report form........................................................................... 1-3
The case report form in the context of document-based surveillance........... 1-3
Patients for whom form is indicated............................................................... 1-3
Definition of variable designators .................................................................. 1-3
Disposition of form.......................................................................................... 1-3
Section I, Patient identification………..……………………….. ....................... 1-4
Section II, Health department use only.......................................................... 1-5
Section III, Facility providing information ....................................................... 1-6
Section IV, Patient demographics................................................................... 1-7
Section V, Residence at diagnosis................................................................. 1-8
Section VI, State/local use only...................................................................... 1-9
Section VII, Facility of diagnosis…................................................................ 1-11
Section VIII, Patient history........................................................................... 1-12
Section IX, Laboratory data………………….................................................... 1-15
Section X, Clinical .......................................................................................... 1-19
Section XI, Treatment/services referral ......................................................... 1-20
Section XII, HIV Testing and Antiretroviral use history................................... 1-21
Section XIII, Comments, Local/optional fields................................................ 1-25
Appendix: Adult HIV Confidential Case Report............................................... 1-26
Instructions for Completion............................................................................. 1-26
Section I, Patient identification.............……………………......................... 1-26
Section II, Health department use only ...................................................... 1-26
Document Source Codes for HIV/AIDS Reporting................................. 1-26
Section IV, Patient demographics……....................................................... 1-28
Section V, Residence at diagnosis…......................................................... 1-30
Section VI, State/local use only.................................................................. 1-31
Section VII, Facility of diagnosis ................................................................ 1-31
Section VIII, Patient history ......................................................................... 1-31
Section X, Clinical………............................................................................ 1-33
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Technical Guidance for HIV Surveillance Programs — Adult HIV Confidential
Case Report
Instructions for Completion
Purpose of case report form
The Adult HIV Confidential Case Report (CDC 50.42A/CDC 50.42C) form is designed to collect
information that promotes understanding of HIV infection morbidity and mortality among United States
residents greater than or equal to 13 years of age at time of diagnosis. This form reflects data that are
required to be collected and optional. This guidance applies to this data collection even if surveillance sites
use a different form or medium for HIV case surveillance.
The case report form in the context of document-based surveillance
Unlike case-based data management, document-based data management allows all documents to be stored
and retained electronically in their original formats. Instead of completing one form for a given reported
case, fill out the applicable part of the form for each data source contributing to that HIV case.
Patients for whom form is indicated
• Each person with newly diagnosed HIV, stage 1, 2 or 3 or unknown stage. (Please see CDC case
definition at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5710a1.htm?s_cid=rr5710a1_e)
• Each person with HIV infection progressing from an earlier or unknown stage to stage 3 (AIDS)
diagnosis.
• When an HIV-infected patient dies, use this form to report the new information.
• Each person with HIV infection who has been reported but for which updated information is
available such as new CD4 or viral load tests reported from a medical provider, additional risk
factor information, or updated current address information.
• If the data are collected electronically and can be imported, recording the information on a form
is not necessary.
Definition of variable designators
• Required: Variables that must be collected by all sites.
• Recommended: Variables that sites are strongly encouraged to collect but are not absolutely
required.
• Optional: Variables that sites may or may not choose to collect.
Disposition of form
• The completed form is for state or local health agency use and is not to be sent to the Centers
for Disease Control and Prevention (CDC). The Pacific Islands are the only sites that send
forms to CDC for data entry and all patient identifiers should be removed before they are sent.
• Data obtained from these forms are entered into compatible or standardized computer software
provided by the Division of HIV/AIDS Prevention, National Center for HIV, Viral Hepatitis,
STD, and TB Prevention, CDC, and then transferred without identifiers to CDC electronically
by encrypted electronic transfer via secure data network.
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1. Patient Identification
*Information NOT transmitted to CDC
Patient identifier information is for state/local health department use only and is not transmitted to CDC.
Enter the data below for all persons reported with HIV.
1.1
PATIENT NAME (Required, applies to Health Dept & Health Care Providers)
•
Enter patient’s first name, middle name, and last name.
1.2
LAST NAME SOUNDEX (Required, applies to Health Dept & Health Care Providers)
• After patient name is entered into CDC-supplied software, the software generates this variable by
using the patient’s last name. After the code is automatically generated, health department staff
should fill this field on the form.
• This variable is a phonetic, alphanumeric code calculated by converting a surname into an index
letter and a three-digit code. The index letter is the first letter of the surname. The eHARS
Technical Reference Guide describes exactly how the Last Name Soundex is created.
1.3
ALTERNATE NAME TYPE (Optional)
• If available, write in the alternate name type (such as Alias, Married) and patient’s alternative first
name, middle name, and last name.
1.4 ADDRESS TYPE (Required, applies to Health Dept & Health Care Providers)
• Select one of the address types (residential, bad address, correctional facility, foster home,
homeless, postal, shelter, or temporary) for the patient’s current address.
1.5
CURRENT STREET ADDRESS (Required, applies to Health Dept & Health Care Providers)
• Enter the patient’s current street address.
1.6
PHONE (Required if patient has a telephone, applies to Health Dept & Health Care Providers)
• Enter patient’s current home area code and telephone number.
1.7
CITY (Required, applies to Health Dept & Health Care Providers)
•
Enter patient’s current city
1.8 COUNTY (Required, applies to Health Dept & Health Care Providers)
• Enter patient’s current county
1.9
STATE/COUNTRY (each element Required, applies to Health Dept & Health Care Providers)
• Enter patient’s current state/country
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1.10 ZIP CODE (Required, applies to Health Dept & Health Care Providers)
• Enter patient’s current zip code
1.11 MEDICAL RECORD NUMBER
• Enter medical record number of the patient if available.
• Refer to Appendix 1.11 for further guidance.
1.12–1.13 OTHER ID TYPE AND NUMBER
• Enter any additional patient’s ID type (such as social security number) and the number of the other
ID. For a list of ID types, please reference the eHARS Technical Reference Guide.
2. Health Department Use Only
2.1
DATE RECEIVED AT HEALTH DEPARTMENT (Optional)
• Enter date in mmddyyyy format.
2.2
eHARS DOCUMENT UID
• Enter UID after CDC-supplied software generates this variable.
2.3
STATE NUMBER (Required)
• Enter the assigned state patient number.
• Each patient should have a unique state number throughout the course of HIV disease in each
state/jurisdiction where they are reported.
• Assigned numbers should not be reused, even if the case is later deleted.
• This variable is used, along with the state of report, to uniquely identify cases
reported to CDC and to merge the state datasets without duplication.
2.4
REPORTING HEALTH DEPARTMENT -CITY/COUNTY (Required)
• Enter name of city and county of the health department that receives the report from providers of
surveillance data.
2.5
CITY/COUNTY NUMBER
• Enter the assigned city/county patient number.
• Each patient should have a unique city/county number throughout the course of HIV disease
assigned by the separately funded city in which they are reported.
• Assigned numbers should not be reused, even if the case is later deleted.
2.6
DOCUMENT SOURCE (Required, applies to Health Dept)
• Enter the code for the document source that provided the information for this report (formerly
report source).
• To clearly identify multiple data sources for a given HIV case (all stages), use a separate case
report form for each source.
• If coding proves difficult, write in document source for later coding.
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•
2.7
2.8
Refer to Appendix 2.6 for code information.
SURVEILLANCE METHOD (Required)
• Enter the method the case report was ascertained- active, passive, follow up, reabstraction or
unknown.
• For definitions of active, passive, follow up, re-abstraction refer to Volume 1 of the Technical
Guidance for HIV Surveillance Programs —Access to Source Data, Case Finding and
Completeness of Reporting.
DID THIS REPORT INITIATE A NEW INVESTIGATION? (Optional)
• Enter whether this case report initiated a new investigation by the health department- yes, no or
unknown.
2.9
REPORT MEDIUM (Optional)
• Health department staff review medical records at provider sites or receive information over the
telephone, by fax, e-mail, US mail, etc. to establish an HIV case and to elicit information for HIV
case report forms. The health department can also receive HIV case reports from physicians,
laboratories, or other individuals or institutions through electronic transfer or CD/disks. Enter the
medium in which the case report was submitted. Choose one of the following options: Field visit,
mail, fax, phone, electronic transfer or CD/Disk.
3. Facility Providing Information
3.1
FACILITY NAME (Optional, applies to Health Dept & Health Care Providers)
• Enter name of the facility providing the information.
• If HIV, stage 1-2 or 3(AIDS) were reported from different facilities, enter name of each on
separate forms, specifying which occurred at which facility.
3.2
PHONE (Optional, applies to Health Dept & Health Care Providers)
• Enter facility’s current area code and telephone number.
3.3
STREET ADDRESS (Optional, applies to Health Dept & Health Care Providers)
• Enter facility’s street address.
3.4
CITY (Optional applies to Health Dept & Health Care Providers)
• Enter city where facility providing information is located.
3.5 COUNTY (Optional applies to Health Dept & Health Care Providers)
• Enter county where facility providing information is located.
3.6
STATE/COUNTRY (Optional, applies to Health Dept & Health Care Providers)
• Enter state, country name where facility providing information is located.
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3.7
ZIP CODE (Optional, applies to Health Dept & Health Care Providers)
• Enter ZIP code where facility providing information is located.
3.8
FACILITY TYPE (Required, applies to Health Dept & Health Care Providers)
• Select applicable response corresponding to the type of facility providing information: Inpatient;
Outpatient; Screening, Diagnostic, Referral Agency; Other Facility.
3.9
DATE FORM COMPLETED (Required, applies to Health Dept & Health Care Providers)
• Enter date in mmddyyyy format.
3.10 PERSON COMPLETING FORM (Optional, applies to Health Dept & Health Care Providers)
• Enter the name of the person completing the form who can be contacted to clarify entries and
supply additional information.
3.11 PHONE (Optional, applies to Health Dept & Health Care Providers)
• Enter the telephone number of the person completing the form.
4. PATIENT DEMOGRAPHICS
4.1
SEX ASSIGNED AT BIRTH (Required, applies to Health Dept & Health Care Providers)
• Select patient’s sex assigned at birth.
• Refer to Appendix 4.1 for further details.
4.2
COUNTRY OF BIRTH (Optional, applies to Health Dept & Health Care Providers)
• Select applicable response from boxes provided.
• Refer to Appendix 4.2 for legal values when dependency or country is to be specified.
4.3
DATE OF BIRTH (Required, applies to Health Dept & Health Care Providers)
• Enter patient’s month, day, and year of birth.
• Enter date in mmddyyyy format.
4.4 ALIAS DATE OF BIRTH (Optional, applies to Health Dept & Health Care Providers)
•
•
4.5
If available, write in the Alias date of birth.
Enter date in mmddyyyy format.
VITAL STATUS (Required, applies to Health Dept & Health Care Providers)
• Select applicable response.
• For further guidance on death ascertainment, see CDC’s Technical Guidance for HIV Surveillance
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Programs, Volume I: Policies and Procedures, Death Ascertainment.
4.6
DATE OF DEATH (Required if applicable, applies to Health Dept & Health Care Providers)
• If patient is deceased, enter date of death.
• Enter date in mmddyyyy format.
• For further guidance on death ascertainment, see CDC’s Technical Guidance for HIV Surveillance
Programs, Volume I: Policies and Procedures, Death Ascertainment.
4.7
STATE OF DEATH (Optional if applicable, applies to Health Dept & Health Care Providers)
• If patient is deceased, enter the state/territory where death occurred.
4.8
CURRENT GENDER IDENTITY (Optional if applicable, applies to Health Dept & Health Care
Providers)
• Enter the current gender identity of the patient, even if it is the same as the sex assigned at birth
male, female, transgender male-to-female, transgender female-to-male, unknown, or additional
gender identity.
• If the person’s stated gender identity differs from of the selections provided, please check the
additional gender identity box and specify in the blank.
4.9
ETHNICITY (Required, applies to Health Dept & Health Care Providers)
• Select applicable response.
• If no ethnicity information is available, select “Unknown”.
• Do not choose unknown unless search for this datum was unsuccessful.
• Refer to Appendix 4.9 for further details.
4.10 EXPANDED ETHNICITY (Optional, if applicable, applies to Health Dept & Health Care Providers)
• Enter more specific ethnicity information for greater detail such as “Hispanic or Latino, Cuban or
Hispanic or Latino. Puerto Rican”.
• Refer to the eHARS Technical Reference Guide for listing of expanded ethnicity.
4.11 RACE (Required, applies to Health Dept & Health Care Providers)
• Select patient’s race even if information was submitted for ethnicity.
• Select more than one race if applicable.
• If no race information is available, select “Unknown”.
• Refer to Appendix 4.11 for further details.
4.12 EXPANDED RACE (Optional, if applicable, applies to Health Dept & Health Care Providers)
•
Enter more specific race information for greater detail such as “American Indian or Alaska
Native.Navajo” or “White. Middle Eastern or North Africa.Egyptian”.
Refer to the eHARS Technical Reference Guide for listing of expanded race.
•
5. RESIDENCE AT DIAGNOSIS
•
Refer to Appendix 5.0 for further guidance.
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5.1
ADDRESS TYPE (Required, applies to Health Dept & Health Care Providers)
• Select the address type (residence at HIV diagnosis, residence at AIDS diagnosis, check if same as
current address) for the patient’s residence at diagnosis being reported on the case report form
• If the patient’s residence at HIV diagnosis and AIDS diagnosis was the same, you may check both.
5.2 STREET ADDRESS (Required, applies to Health Dept & Health Care Providers)
• Enter residence’s street address at diagnosis.
5.3 CITY (Required, applies to Health Dept & Health Care Providers)
• Enter city of patient’s residence at diagnosis.
5.4 COUNTY (Required, applies to Health Dept & Health Care Providers)
• Enter county of patient’s residence at diagnosis.
5.5 STATE/COUNTRY (Required, applies to Health Dept & Health Care Providers)
• Enter the state/country of patient’s residence at diagnosis.
5.4 ZIP CODE (Required, applies to Health Dept & Health Care Providers)
• Enter the ZIP code of patient’s residence at diagnosis.
6. STATE/LOCAL USE ONLY
Diagnosing physician or healthcare provider identifier information is supplied in this section.
6.1
PHYSICIAN’S NAME (Optional)
• Enter name of physician who diagnosed patient (last, first, M.I.).
• Enter name of physician medically managing patient.
• Refer to Appendix 6.1 for further guidance.
6.2
PHONE NO. (Optional)
• Enter phone number of physician named at 6.1, above.
• If no physician is named, enter phone number of the facility of diagnosis.
6.3
MEDICAL RECORD NO.
• Enter medical record number of the patient if available that is being used by the
physician or healthcare provider who diagnosed the patient (if different).
• Refer to Appendix 1.10 for further guidance.
6.4
HOSPITAL/FACILITY (Optional)
• Enter the name of the facility where the report originated.
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•
6.5
If this report is generated from a laboratory report of HIV infection, the laboratory
slip should contain the name of the facility where the specimen was collected.
PERSON COMPLETING FORM (Optional, applies to Health Dept & Health Care Providers)
• Enter the name of the person completing the form who can be contacted to clarify
entries and supply additional information.
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7. FACILITY OF DIAGNOSIS
7.1
7.2
7.3
7.4
7.5
7.6
7.7
7.8
7.9
7.10
7.11
7.12
DIAGNOSIS TYPE
• Enter the diagnosis type that corresponds to the facility of diagnosis being reported.
FACILITY NAME (Optional, applies to Health Dept & Health Care Providers)
• Enter name of the facility where patient was first diagnosed with diagnosis type
being reported.
• If HIV, stage 1-2, unknown and stage 3 (AIDS) diagnoses occurred at different
facilities, enter name of each on separate forms, specifying which diagnosis
occurred at which facility.
• Refer to Appendix 7.2 for further details.
PHONE (Optional, applies to Health Dept & Health Care Providers)
• Enter facility’s current area code and telephone number.
STREET ADDRESS (Optional, applies to Health Dept & Health Care Providers)
• Enter facility’s street address.
CITY (Optional, applies to Health Dept & Health Care Providers)
• Enter city where facility of diagnosis is located.
COUNTY (Optional, applies to Health Dept & Health Care Providers)
• Enter county where facility of diagnosis is located.
STATE/COUNTRY (Optional, applies to Health Dept & Health Care Providers)
• Enter state, country name where facility of diagnosis is located.
ZIP CODE (Optional, applies to Health Dept & Health Care Providers)
• Enter ZIP code where facility of diagnosis is located.
FACILITY TYPE (Required, applies to Health Dept & Health Care Providers)
• Select applicable response corresponding to the type of facility where patient
received reported diagnosis of HIV.
• Refer to Appendix 7.9 for further details.
PROVIDER NAME (Optional)
• Enter provider’s name where patient first received a diagnosis of HIV, stage 1-2 or
stage 3 (AIDS).
PROVIDER PHONE (Optional)
• Enter provider’s current area code and telephone number.
SPECIALTY
• Enter provider’s specialty.
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8. PATIENT HISTORY
These data yield information about how patients may have acquired their infections.
8.1
•
•
Respond to each risk factor, selecting “Yes” for all factors that apply; “No” for those that do not
apply, i.e., only select “No” if medical record specifically states this is not a risk factor; and
“Unknown” for those for which investigation failed to yield an answer. If an investigation for a
particular item was not performed, then you should leave it blank.
•
Mark if the risk factor was a pediatric risk on the top of this section and enter additional
information in the COMMENTS section.
•
If these brief instructions are insufficient, see Appendix Section 8.0 for further guidance about how
to ascertain risk factor information. See Technical Guidance for HIV Surveillance Programs,
Volume 1: Policies and Procedures, Risk Factor Ascertainment for further guidance on HIV risk
factor ascertainment, relevant definitions, and clarification of risk factors.
SEX WITH MALE (Required, applies to Health Dept & Health Care Providers)
Some examples of information from the medical record which would strongly indicate sex with a
male are
o For male patient
Married to or divorced from a male
Rectal gonorrhea
o For female patient
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8.2
Married to or divorced from a male
Boyfriend referenced in the medical record
Living with a male “partner”
History of pregnancy
History of another sexually transmitted infection (in addition to HIV)
Sex worker (either current or in the past)
SEX WITH FEMALE (Required, applies to Health Dept & Health Care Providers)
•
Some examples of information from the medical record which would strongly indicate sex with a
female are
o For male patient
Married to or divorced from a female
Has a biological child
o For female patient
Married to or divorced from a female
8.3
INJECTED NON-PRESCRIPTION DRUGS (Required, applies to Health Dept & Health Care
Providers)
• Select applicable response.
8.4
RECEIVED CLOTTING FACTOR FOR HEMOPHILIA/COAGULATION DISORDER (Required,
applies to Health Dept & Health Care Providers)
• “Coagulation disorder” or “hemophilia” refers only to a disorder of a clotting factor; factors are any
of the circulating proteins named Factor I through Factor XII. These disorders include Hemophilia
A and Von Willebrand’s disease (Factor VIII disorders) and Hemophilia B (a Factor IX disorder).
•
•
8.5
Select applicable response.
This risk factor is generally documented in the history and physical section of the patient’s medical
chart.
• If “Yes” specify the clotting factor and enter date received. Enter date in mmddyyyy format.
• They do not include other bleeding disorders, such as thrombocytopenia, treatable by
platelet transfusion.
• If only a transfusion of platelets, other blood cells, or plasma was received by the partner,
then select “No.”
HETEROSEXUAL RELATIONS WITH ANY OF THE FOLLOWING: This section, addressed at
8.5.1–8.5.6, relates to ascertainment of risk among persons who had heterosexual contact (had sex
with) with the case patient.
8.5.1 INTRAVENOUS/INJECTION DRUG USER (Required, applies to Health Dept & Health Care
Providers)
• Select applicable response.
8.5.2 BISEXUAL MALE (Required, applies to Health Dept & Health Care Providers)
• Applies only to female cases.
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•
Select applicable response.
8.5.3 PERSON WITH HEMOPHILIA/COAGULATION DISORDER WITH DOCUMENTED HIV
INFECTION (Required, applies to Health Dept & Health Care Providers)
• Select applicable response.
• “Coagulation disorder” or “hemophilia” refers only to a disorder of a clotting factor. They
do not include other bleeding disorders, such as thrombocytopenia, treatable by platelet
transfusion. If only a transfusion of platelets, other blood cells, or plasma was received by
the partner, then select “No.”
• Refer to Protocol for Evaluation of Identification and Follow-up of Cases of Public Health
Importance at http://www2a.cdc.gov/hicsb/docs/COPHI_Protocol.pdf for more information.
8.5.4–8.5.5 TRANSFUSION RECIPIENT WITH DOCUMENTED HIV INFECTION—
TRANSPLANT RECIPIENT WITH DOCUMENTED HIV INFECTION (Required, applies to
Health Dept & Health Care Providers)
• Select applicable response.
• Consider documenting the reason for transfusion/transplant in the Comments section.
• Refer to Appendix 8.5.3 for further details.
8.5.6 PERSON WITH DOCUMENTED HIV INFECTION, RISK NOT SPECIFIED (Required,
applies to Health Dept & Health Care Providers)
• Select “Yes” only if HETEROSEXUAL sex partner is known to be HIV positive and that
partner’s risk factor for HIV is unknown.
8.6
RECEIVED TRANSFUSION OF BLOOD/BLOOD COMPONENTS (OTHER THAN CLOTTING
FACTOR) (Required, applies to Health Dept & Health Care Providers)
• ‘Blood,’ according to http://cancerweb.ncl.ac.uk/cgi-bin/omd?blood, is defined as a circulating
tissue composed of a fluid portion (plasma) with suspended formed elements (red blood cells,
white blood cells, platelets).
• ‘Blood components’ that can be transfused, according to http://cancerweb.ncl.ac.uk/cgibin/omd?blood, include erythrocytes, leukocytes, platelets, and plasma.
• If “Yes,” specify month, day, and year of first and last transfusions before occurrence of patient’s
HIV diagnosis.
• It is often helpful to document the reason for the transfusion in the Comments section.
• Refer to Protocol for Evaluation of Identification and Follow-up of Cases of Public Health
Importance at http://www2a.cdc.gov/hicsb/docs/COPHI_Protocol.pdf for more information.
8.7
RECEIVED TRANSPLANT OF TISSUE/ORGANS OR ARTIFICIAL INSEMINATION (Required,
applies to Health Dept & Health Care Providers)
• Select applicable response.
• Alert the state/local cases of public health importance (COPHI) coordinator.
8.8
WORKED IN HEALTH CARE OR CLINICAL LABORATORY SETTING (Required, applies to
Health Dept & Health Care Providers)
• Select applicable response.
• If “Yes,” specify occupation and setting.
• Investigate apparent occupational exposures to determine if this was the only risk factor present.
OTHER DOCUMENTED RISK (Alert State/Local NIR Coordinator) (Required, applies to Health
Dept & Health Care Providers)
• Select this response only if directed to do so by the state/local NIR coordinator.
8.9
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9. LABORATORY DATA
“COLLECTION DATE” refers to the date when the specimen was obtained from the patient.
9.1
•
Enter dates in mmddyyyy format.
•
If search for either or both of these data was unsuccessful, then enter “..” for unknown day, month
or year of “COLLECTION DATE.”
•
Record all laboratory tests.
•
Include all diagnostic, viral detection, and CD4 tests where possible. Where number of tests
exceeds the number of fields available on the form, record such results in the Comments section.
•
In the absence of lab tests, record HIV, stage 1-2 or stage 3 (AIDS) diagnostic evidence
documented in the chart by a physician.
•
If the following brief instructions for recording HIV-related tests are insufficient, see the Technical
Guidance for HIV Surveillance Programs, Volume I: Policies and Procedures, Electronic
Reporting, HIV and HIV-associated Laboratory Tests.
HIV ANTIBODY TESTS (NON_TYPE DIFFERENTIATING)
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•
Assuming active case finding, review patient’s chart and lab reports for the earliest date of
documented HIV positivity, “Indeterminate” refers to Indeterminate HIV antibody test results.
•
Enter results and collection dates for first positive HIV antibody tests.
•
The possible results are: Positive/Reactive, Negative/Nonreactive, or Indeterminate
•
Check the Rapid Test box if the test is rapid.
•
Enter date in mmddyyyy format.
•
Enter the name of assay manufacturer
9.1.1 HIV-1 EIA (each element Required, applies to Health Dept & Health Care Providers)
• Enter result and collection date of first HIV-1 EIA.
• “Positive EIA” means repeatedly reactive tests on a single sample.
• Enter date in mmddyyyy format.
9.1.2 HIV-1/2 COMBINATION EIA (each element Required, applies to Health Dept & Health Care
Providers)
• Enter result and collection date of first HIV-1/ 2 combination EIA test.
• If tests indicate HIV-1 or HIV-2 results separately, please specify the results as given in the
laboratory report.
• Enter date in mmddyyyy format.
9.1.3 HIV-1/2AgAb
• Enter results and collection date of combined p24 antigen and anti HIV1/2 antibody screening
assay.
• Enter date in mmddyyyy format.
9.1.4 HIV-1 WESTERN BLOT (each element Required, applies to Health Dept & Health Care
Providers)
• Enter the result and collection date of first HIV-1 Western blot.
• Enter date in mmddyyyy format.
9.1.5 HIV-1 IFA (each element Required, applies to Health Dept & Health Care Providers)
• Enter the result and collection date of first HIV-1 IFA.
• Enter date in mmddyyyy format.
9.1.6 HIV-2 EIA (each element Required, applies to Health Dept & Health Care Providers)
• Enter result and date of first HIV-2 EIA.
• “Positive EIA” means repeatedly reactive tests on a single sample.
• Enter date in mmddyyyy format.
9.1.7 HIV-2 WESTERN BLOT (each element Required, applies to Health Dept & Health Care
Providers)
• Enter the result and collection date of first HIV-2 Western blot. Enter date in mmddyyyy
format.
• If HIV-1 tests other than those at 9.1.1–9.1.5 were employed, specify the type of test
performed.
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•
•
Enter the result and collection date.
Enter date in mmddyyyy format.
9.2 HIV ANTIBODY TESTS (TYPE DIFFERENTIATING)
•
Assuming active case finding, review patient’s chart and lab reports for the earliest date of
documented HIV positivity.
•
Enter results and collection dates for first positive HIV antibody tests. The possible results are:
HIV-1, HIV-2, Both (undifferentiated), or Neither (negative).
•
Enter date in mmddyyyy format.
9.3
HIV DETECTION TESTS (QUALITATIVE) (Required, applies to Health Dept & Health
Care Providers)
•
These are all qualitative tests. All varieties of such tests establish the presence of the pathogen,
HIV. By contrast, HIV tests such as the EIA or Western blot establish the presence of our immune
systems’ response to the pathogen—HIV antibodies.
•
Select applicable response corresponding to earliest positive detection test.
•
The possible results are: Positive/Reactive, Negative/Nonreactive, or Indeterminate.
9.3.1 HIV-1 RNA/DNA NAAT (QUAL)
9.3.2 HIV-1 P24 ANTIGEN (Required, applies to Health Dept & Health Care Providers)
• Antigens are the virus’s own proteins; such tests are specific for these proteins.
• Enter result and collection date of earliest antigen test.
• Enter date in mmddyyyy format.
9.3.3 HIV-1 CULTURE (Required, applies to Health Dept & Health Care Providers)
• Enter result and collection date of earliest test by culture.
• Enter date in mmddyyyy format.
9.3.4 HIV-2 RNA/DNA NAAT (QUAL)
9.3.5 HIV-2 CULTURE (Required, applies to Health Dept & Health Care Providers)
• Enter result and collection date of earliest test by culture.
• Enter date in mmddyyyy format.
9.4
HIV DETECTION TESTS (QUANTITATIVE VIRAL LOAD)
•
9.4.1
HIV-1 RNA/DNA NAAT (QUANTITATIVE VL)
•
The possible results are: Detectable or Undetectable
•
Enter results in units of copies per milliliter (mL) and Log. Enter the month, day, and year
test was collected. Viral load tests with undetectable results should also be entered here.
•
COPIES/ML (each element Required, applies to Health Dept & Health Care Providers)
Enter result in units of viral copies per milliliter. Where detectable results are reported with
log data only, enter “greater than detection limits for this assay” under the copies/mL field.
Because undetectable results are typically reported as below the detection limits of the
assay rather than by a specific quantitative value, enter “fewer than detectable by this
assay” under the copies/mL field
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9.5
IMMUNOLOGIC TESTS (CD4 COUNT AND PERCENTAGE)
•
Whenever CD4 count and percentage are both available, record both. Enter specimen collection
date to the reported CD4 test result
9.5.1 CD4 AT OR CLOSEST TO CURRENT DIAGNOSTIC STATUS
9.5.1.1 CD4 COUNT (Required, applies to Health Dept & Health Care Providers)
• For HIV reports, record the CD4 count closest to the time patient was determined
to be HIV infected. If this information is not available when the initial case report
is completed, it may be entered later. For HIV, stage 3 (AIDS) reports, record the
CD4 count with date at or closest to the date of stage 3 (AIDS) diagnosis. This
stage 3 (AIDS) diagnosis date is typically the date on which an AIDS-defining
illness is diagnosed or the specimen collection date of a CD4 count < 200 cells/μL.
9.5.1.2 CD4 PERCENTAGE (Required, applies to Health Dept & Health Care Providers)
• For HIV reports, record the CD4 percentage with date at or closest to the date of
HIV diagnosis. For stage 3 (AIDS) reports, record the CD4 percentage at or
closest to the time that an AIDS-defining clinical condition was first diagnosed.
This stage 3 (AIDS) diagnosis date is typically the date on which an AIDSdefining illness is diagnosed or the specimen collection date of a CD4 percent
<14%.
9.5.2 FIRST CD4 RESULT < 200 cells/μL or < 14%
9.5.2.1 CD4 COUNT (Required if available, applies to Health Dept & Health Care
Providers)
• Enter results and specimen collection date of first CD4 < 200 cells/μL.
• Enter date in mmddyyyy format.
9.5.2.2 CD4 PERCENTAGE (Required if available, applies to Health Dept & Health Care
Providers)
• Record results and specimen collection date of first CD4 <14%.
• Enter date in mmddyyyy format.
9.5.3 Other CD4 RESULT
9.5.3.1 CD4 COUNT (Required if available, applies to Health Dept & Health Care
Providers)
• Enter results and specimen collection date of other CD4 count.
• Enter date in mmddyyyy format.
9.5.3.2 CD4 PERCENTAGE (Required if available, applies to Health Dept & Health Care
Providers)
• Record results and specimen collection date of other CD4 percentage.
• Enter date in mmddyyyy format.
9.6
DOCUMENTATION OF TESTS
9.6.1 DATE OF EARLIEST POSITIVE TEST FOR MEETING THE HIV DIAGNOSTIC
ALGORITHM CRITERIA
• This section captures diagnoses through novel algorithms, and should only be completed if
none of the following were positive: HIV-1 Western blot; p24 Ag test ; or qualitative NAAT
(RNA or DNA) or a detectable viral load
• Select applicable response.
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•
If “Yes”, enter date of earliest positive test for this algorithm in mmddyyyy format.
9.6.2 IF HIV LABORATORY TESTS WERE NOT DOCUMENTED, IS HIV DIAGNOSIS
DOCUMENTED BY A PHYSICIAN? (Required if applicable, applies to Health Dept & Health Care
Providers)
•
Select applicable response. If laboratory evidence of an HIV test is unavailable in the
patient’s medical or other record and written documentation of lab evidence of HIV
infection consistent with the HIV case definition is noted by the physician, enter “Yes”;
otherwise enter “No” or “Unknown.”
• IF “YES” TO 9.6.2, PROVIDE DATE OF DOCUMENTATION BY PHYSICIAN
(Required in the absence of lab results, applies to Health Dept & Health Care Providers)
• If antibody tests are not available in chart, enter date of the note in which the physician
documents the patient’s HIV infection. Do not record earlier date stated by the patient or the
date that the physician says in the note. For example, if a health care provider writes a note
in a medical chart on 4/10/2010 stating the patient had positive HIV EIA and WB the
previous month. This should be recorded as 4/10/2010 as the date of documentation by the
physician.
• Enter date in mmddyyyy format.
9.6.3 DATE OF LAST DOCUMENTED NEGATIVE HIV TEST (SPECIFY TYPE)
• Enter type of test and specimen collection date. A negative HIV test result does not
necessarily represent absence of infection. Because antibody tests such as the HIV-EIA are
the standard means of screening for HIV infection, the test type specified in this field is
typically an antibody test. Additionally, HIV-2 infection would be missed by assays specific
to detection of HIV-1 antibodies; such case reports could include a previous HIV-1 negative
antibody test result here. By contrast, other HIV tests, such as those measuring viral load,
are typically ordered for patients already known to be infected; so these are not included
here. Patient self-report of last negative test is not considered “documented” and thus should
not be entered in this field.
• Enter date in mmddyyyy format.
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10. CLINICAL
10.1 CLINICAL
10.1.1–10.1.26 (Optional, applies to Health Dept & Health Care Providers)
• Select all that apply and enter diagnosis dates. Enter date in mmddyyyy format.
• Refer to Appendix 10.1 for further details.
10.1.27 RVCT CASE NUMBER
• If this patient has a verified case of tuberculosis (TB), health department staff enter the
nine-digit alphanumeric code from the TB case report or TB data management system.
Providers in the private and public sectors diagnosing tuberculosis in their AIDS patients
may get this number from TB surveillance staff.
11. TREATMENT/SERVICES REFERRALS
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11.1 HAS THIS PATIENT BEEN INFORMED OF HIS/HER HIV INFECTION? (Optional, applies to
Health Dept & Health Care Providers)
•
Select applicable response.
•
If notification is not documented, select “Unknown” unless the person completing the form knows
with certainty that the patient is aware of the infection.
11.2 THIS PATIENT’S PARTNERS WILL BE NOTIFIED ABOUT THEIR HIV EXPOSURE AND
COUNSELED BY (Optional, applies to Health Dept & Health Care Providers)
•
Select applicable response.
11.3 FOR FEMALE PATIENT
11.3.1 THIS PATIENT IS RECEIVING OR HAS BEEN REFERRED FOR GYNECOLOGICAL OR
OBSTETRICAL SERVICES (Optional, applies to Health Dept & Health Care Providers)
• Select applicable response.
11.3.2 IS THIS PATIENT CURRENTLY PREGNANT? (Required, applies to Health Dept & Health
Care Providers)
• Select applicable response. Response is dependent on which date was selected for
populating the field described for Date form completed. If patient was pregnant on that
date, select “Yes.”
11.3.3 HAS THIS PATIENT DELIVERED LIVE-BORN INFANTS? (Optional, applies to Health
Dept & Health Care Providers)
• Select applicable response.
• If “Yes”, provide birth information for the most recent birth as described at 11.4 below.
• Information on additional or multiple births can be recorded in Comments.
11.4 FOR CHILDREN OF PATIENT
11.4.1 CHILD’S NAME
• Enter name of child.
11.4.2 CHILD’S SOUNDEX
• To be completed by state/local health department personnel.
• Retrieve soundex from the HIV registry (database) and enter here if child’s name was
previously entered in your database and a Stateno exists.
• If child’s name has not been entered yet, enter name and date of birth information in the
CDC-provided software. This software will convert child’s surname to a soundex code.
Enter date in mmddyyyy format.
11.4.3 CHILD’S DATE OF BIRTH
• Enter child’s month, day, and year of birth. Enter date in mmddyyyy format.
• Child to whom field refers is from the most recent birth.
11.4.4 CHILD’S CODED ID
• Enter any additional patient’s ID type (such as social security number) and the number of
the other ID.
11.4.5 CHILD’S STATE NUMBER.
• To be completed by state/local health department personnel.
• This number is typically assigned by state/local health department personnel if the child is
known to have received a diagnosis of HIV (all stages). Some states also assign numbers
for children classified as “Perinatally HIV Exposed” or “Seroreverter.”
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11.5 HOSPITAL OF BIRTH
•
Enter the name, street address, phone number, city, county, and state of the hospital where the
child described at 11.4 above was born.
•
If the child was born at home, enter “home birth.”
12. HIV Testing and Antiretroviral Use History Section
The HIV testing and antiretroviral use history section is required for the use of state and local health
departments that conduct HIV Incidence Surveillance (HIS). The medication use questions are also required
for areas conducting Molecular HIV Surveillance (MHS). This section is optional for all other surveillance
areas. These testing and treatment history (TTH) data are used along with the serologic testing algorithm for
recent HIV seroconversion (STARHS) results to generate national, state and local HIV incidence estimates.
Unlike other sections on the ACRF, patient self-reported information is accepted for all answers. For
detailed instructions, consult the Guidance for Collection and Data Entry of HIV Incidence Surveillance
Information.
12.1
12.2
MAIN SOURCE OF TESTING AND TREATMENT (TTH) INFORMATION
•
Check only one source, the main source from which the information in this section was obtained.
•
‘Patient Interview’ is selected only if the patient was directly asked a series of questions from
this or another structured TTH form. Interviewer should have been trained on the proper
collection of TTH data.
•
‘Provider Report’ indicates this form is filled out by a health care provider.
•
‘Medical Record Review’ indicates that this information was obtained through abstraction of
medical charts, electronic medical records or databases. Information may also come from a
database of HIV test results or pharmacy records.
•
‘NHM&E/PEMS’ indicates that data were abstracted from the National HIV Monitoring and
Evaluation (NHM&E) project forms or databases.
•
‘Other’ indicates that information came from a source other than those listed above.
DATE PATIENT REPORTED INFORMATION
•
The appropriate date to enter depends on the MAIN SOURCE OF TTH INFORMATION:
•
If there is a structured patient interview, enter the date of the interview. Enter date in mmddyyyy
format.
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TG Attach 4a Vol2_revised_ADULT_2012
•
For a medical record review, enter the date of the last patient encounter that contributed to the
TTH information collected. If only a lab report was accessed, enter the date of receipt of the lab
results. If there was no patient encounter or lab test receipt date, then enter the date the medical
record review was performed. Enter date in mmddyyyy format.
•
If the ACRF is completed by a health care provider, enter the date of the last patient encounter
when the most recent TTH information was obtained from the patient. If provider’s information
only came from another data source, such as a lab report, enter the date of receipt of the
information. If there are no such dates, enter the date the ACRF was completed. Enter date in
mmddyyyy format.
For information obtained through NHM&E/PEMS, use the date entered on the HIV Test Form.
•
12.3
12.4
12.5
If there are no data available from the above sources, enter the date the ACRF was completed.
Enter date in mmddyyyy format.
EVER HAD PREVIOUS POSITIVE HIV TEST?
•
The purpose of this question is to report if any positive HIV test occurred before the known date
of HIV diagnosis, for example a test performed in another state or country or an anonymous test.
If there is a date of earlier positive HIV test, enter it in the next field on the form. Enter date in
mmddyyyy format.
•
Self-reported information is appropriate.
•
Do not count indeterminate tests.
•
‘Yes’ indicates evidence that the person had a previous positive HIV test, including patient selfreport.
•
‘No’ indicates sufficient evidence that there was no previous positive HIV test. Do not answer
‘no’ if there is a lack of evidence either way about previous tests.
•
‘Refused’ indicates patient refused to answer the question or facility refused to permit medical
record review.
•
‘Don’t know’ indicates that the patient, chart reviewer, or provider has no knowledge whether or
not there was a previous positive HIV test, after searching for the information or asking the
patient. The field should be left blank if the medical record was not searched or the question was
not asked
DATE OF FIRST POSITIVE HIV TEST
•
Record the date of the earliest known positive HIV test, including patient self-reported dates. It is
acceptable to enter an estimated or incomplete date, as long as it contains a year. Enter date in
mmddyyyy format.
•
If it is known that there were no previous positive HIV tests, enter the date of the first positive
HIV test, i.e. the collection date of the diagnostic HIV test, and answer ‘no’ to the previous
question (“Ever had previous positive HIV test”). Enter date in mmddyyyy format.
•
If you do not know the date of HIV diagnosis, enter the earliest known positive HIV test.
EVER HAD A NEGATIVE HIV TEST?
•
Because this question is used to classify persons as new or previous testers for incidence
estimation, it is important to not make assumptions. The mere absence of information about
previous tests in a medical record should not be recorded as ‘no’, since tests can occur in other
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TG Attach 4a Vol2_revised_ADULT_2012
venues.
12.6
12.7
12.8
•
Self-reported information is accepted. Ignore indeterminate tests.
•
‘Yes’ indicates there is knowledge of a previous negative HIV test, either self-reported or
confirmed by a laboratory report. If the answer is ‘yes’, enter the date in the next field on the
form, if it is available. Enter date in mmddyyyy format.
•
‘No’ indicates there is evidence that the person never had a negative HIV test. For example, the
person states they never have been tested before. Do not enter ‘no’ if there is simply no evidence
either way about a previous HIV test.
•
‘Refused’ indicates patient refused to answer the question or facility refused to permit medical
record review.
•
‘Don’t know/Unknown’ indicates there is insufficient evidence supporting or denying the
occurrence of a negative HIV test, after searching for the information or asking the patient.
Leave the question blank if there was no attempt to find the information.
DATE OF LAST NEGATIVE HIV TEST
•
This is the most important information for incidence estimation. This date is used to categorize
persons as repeat testers and to estimate frequency of testing.
•
Self-reported information is accepted. Documented negative HIV test dates also should be
entered in the Laboratory Data section under date of last documented negative HIV test, along
with the test type.
•
Enter the date of the last known negative HIV test, either self-reported or confirmed by a
laboratory test. The person may have had a more recent negative test at another facility,
unknown to the provider or chart abstractor, but it is more important to enter any known date
than to leave it blank.
•
Incomplete dates are acceptable if the year is included.
•
Enter date in mmddyyyy format.
NUMBER OF NEGATIVE HIV TESTS WITHIN 24 MONTHS BEFORE FIRST POSITIVE TEST
•
Count the number of negative HIV tests in the 24 months before the first positive HIV test. Do
not count indeterminate or positive HIV tests or those with unknown results.
•
Enter ‘0’ if it is known that the patient has never been tested for HIV before or never had a
negative test.
•
Check ‘Refused’ if the patient refused to answer the question or facility refused to permit
medical record review.
•
Check ‘Don’t know/Unknown’ if the patient or person completing the form does not know or if
the results of a test are unknown, after searching for the information or asking the patient. Leave
the question blank if there was no attempt to find the information.
EVER TAKEN ANY ANTIRETROVIRALS (ARVS)?
•
This field indicates whether the patient has ever taken any antiretroviral medication to prevent or
treat HIV or hepatitis, particularly before HIV diagnosis. This is important because ARV use
may affect STARHS results. Most patients have not taken ARVs before the date of HIV
diagnosis, but some have taken them for hepatitis or for HIV pre-exposure prophylaxis (PrEP).
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TG Attach 4a Vol2_revised_ADULT_2012
12.9
•
This question is also used to determine specimen eligibility for the Variant, Atypical and
Resistant HIV Surveillance (VARHS) system that monitors the distribution of HIV-1 mutations
associated with HIV drug resistance and subtypes among persons with newly diagnosed HIV
infection.
•
‘Yes’ indicates there is evidence that the person has taken ARVs, including self-report. If ‘Yes’,
it is important to enter the dates when use began and, if appropriate, ended. Enter date in
mmddyyyy format.
•
‘No’ indicates there is evidence that the patient has never taken ARVs.
•
‘Refused’ indicates that the patient refused to answer the question or facility refused to permit
medical record review.
•
‘Don’t know/Unknown’ should be used when the person completing the form does not know
whether or not the patient has ever taken ARV’s, after searching for the information or asking
the patient. Leave the question blank if there was no attempt to find the information.
IF YES, ARV MEDICATIONS
•
This field is used for verification that the medication taken was actually an antiretroviral
medication.
•
It is not necessary to list all medications, only one. However, more can be listed if there is space.
Enter “unspecified” if an ARV was taken but the name is not known.
•
Refer to Appendix C of the Guidance for Collection and Data Entry of HIV Incidence
Surveillance Information for a list of ARV medications.
12.10 DATES ARVS TAKEN: DATE FIRST BEGAN
•
Enter the earliest date that the patient ever took ARV’s, even if ARV use was sporadic.
•
If the first time ARVs were taken occurred after HIV diagnosis, it is very important to enter a
date, even an estimated date, later than the date of HIV diagnosis.
•
Enter date in mmddyyyy format.
12.11 DATES ARVS TAKEN: DATE OF LAST USE
•
Enter the last known date of ARV use.
•
For patients currently on ARV’s, record the date of the last prescription or known usage. If the
information is collected during a patient interview, the date would be the interview date. If the
information was collected as part of a medical record review, record the date of the last
prescription or date of the last physician’s note.
•
Enter date in mmddyyyy format.
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13. COMMENTS AND LOCAL/OPTIONAL FIELDS
13.1 COMMENTS (Optional)
• This section can be used for information not requested on the form or for information
requested but where there might not be room in the space provided. For example,
surveillance staff may document investigative progress toward ascertainment of risk factor
information.
• This information is not sent to CDC.
13.2 LOCAL FIELDS/OPTIONAL FIELDS
• This section is for collection of data that is not on the form at the state and local level.
• This information is not sent to CDC.
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Appendix:
Adult HIV Confidential Case Report
(CDC 50.42A/CDC 50.42C)
Instructions for Completion
1.0 PATIENT IDENTIFICATION
1.11 MEDICAL RECORD NUMBER
• This field may be left blank unless patient was hospitalized as an inpatient or treated as an
outpatient in a hospital, community health center, or health department clinic.
• If the patient has more than one medical record number, enter the number of the primary
record that has HIV, stage 1-2 or HIV, stage 3 (AIDS) documentation. Additional numbers
can be noted in the Comments section, clearly annotating which facility is associated with
which record number.
2.0 HEALTH DEPARTMENT USE ONLY
2.6
DOCUMENT SOURCE
• If “Other database,” “Other Clinic,” “Other,” or “Out of state” is selected, specify source in
Comments.
• Two-level codes for report source are shown below. The first level of source code is
required, and the second level is recommended.
Document Source Codes for HIV Reporting
First level source
A01. = Inpatient
Second (more detailed) level source
A01.01 = IP/Acute care facility
A01.01.02 = IP/ACF/OBGYN records
A01.01.03 = IP/ACF/Pediatric records
A01.01.04 = IP/ACF/Birth records
A01.02 = IP/VA
A01.03 = IP/Military hospital
A01.03.02 = IP/Military/OBGYN records
A01.03.03 = IP/Military/Pediatric records
A01.04 = IP/Long-term care facility
A01.04.03 = IP/LTCF/Drug TX program
A01.05 = IP/Hospice
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First level source
A02. = Outpatient
Second (more detailed) level source
A02.01 = OP/HMO
A02.02 = OP/VA
A02.03 = OP/Private physician
A02.04 = OP/Adult HIV Clinic
A02.05 = OP/Infect. Dis. Clinic
A02.06 = OP/County HD clinic
A02.07 = OP/Maternal HIV clinic
A02.08 = OP/Prenatal clinic or records
A02.09 = OP/Pediatric HIV clinic
A02.10 = OP/OBGYN clinic (not HIV related)
A02.11 = OP/Pediatric clinic
A02.12 = OP/TB clinic
A02.14 = OP/IHS clinic
A02.15 = OP/Early intervention nurse
A02.16 = OP/Visiting nurse service
A02.17 = OP/Hemophilia TX clinic
A02.18 = OP/Hospice
A02.19 = OP/Drug TX center
A02.20 = OP/Rehab center
A02.25 = OP/Other clinic
A03. = Emergency room
A03 = Emergency room
A04. = Screening, diagnosis, and A04.01 = Scr, Dx, Ref/Blood bank
referral agencies
A04.02 = Scr, Dx, Ref/Drug TX program
A04.03 = Scr, Dx, Ref/Family planning clinic
A04.04 = Scr, Dx, Ref/HIV case management agency
A04.05 = Scr, Dx, Ref/HIV counseling & testing site
A04.06 = Scr, Dx, Ref/Immigration report
A04.07 = Scr, Dx, Ref/Insurance report
A04.08 = Scr, Dx, Ref/Job Corps
A04.09 = Scr, Dx, Ref/Military
A04.10 = Scr, Dx, Ref/Partner referral & counseling service
A04.11 = Scr, Dx, Ref/STD clinic
A05. = Laboratory
A05.01 = Lab/hosp.
A05.02 = Lab/state
A05.03 = Lab/private
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First level source
A06. = Other databases
A07. = Other facility records
A10 = Other source
Second (more detailed) level source
A06.01 = Other DB/ADAP
A06.02 = Other DB/ASD
A06.03 = Other DB/Birth certificate
A06.04 = Other DB/Birth defects registry
A06.05 = Other DB/Cancer registry
A06.06 = Other DB/Database from coroner
A06.07 = Other DB/Death certificate review
A06.08 = Other DB/EHRAP database
A06.09 = Other DB/EPS database
A06.10 = Other DB/HARS database
A06.11 = Other DB/Health department records
A06.12 = Other DB/Hepatitis registry
A06.13 = Other DB/Hosp billing summary or discharge data
A06.14 = Other DB/HRSA HIV Care database
A06.15 = Other DB/Immunization registry
A06.16 = Other DB/Medicaid records
A06.17 = Other DB/NDI
A06.18 = Other DB/Out-of-state report
A06.19 = Other DB/Prison, jail, or other correctional facility database
A06.20 = Other DB/PSD
A06.21 = Other DB/State disease registry
A06.22 = Other DB/SHAS
A06.23 = Other DB/SHDC database
A06.24 = Other DB/STD registry
A06.25 = Other DB/TB registry
A06.50 = Other DB/Other database or report
A07.01 = Oth facility records/Prison, jail, or other correctional facility
A07.02 = Oth facility records/Coroner, not associated with IP facility
A10 = Other source
(specify)
Unknown
4.0 PATIENT DEMOGRAPHICS
4.1
Refers to the person’s assigned sex at birth. In addition to “male” or “female” sex at birth, CDCsupplied software includes a third choice of “Unknown.”
•
•
The person completing the form may also record current gender identity.
Selections and legal values for “CURRENT GENDER IDENTITY” from eHARS Lookup
Codes are as follows:
CURRENT_GENDER = M = Person currently identifies as male
CURRENT_GENDER = F = Person currently identifies as female
CURRENT_GENDER = MF = Person currently identifies as transgender, male-to female or
as a similar gender identity (e.g., transwoman, transfeminine)
CURRENT_GENDER = FM = Person currently identifies as transgender, female-to-male
or as a similar gender identity (e.g., transman, transmasculine)
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CURRENT_GENDER = AD = Person currently identifies as a gender that does not
correspond with those listed above (e.g., gender queer)
Please specify the current gender identity.
CURRENT_GENDER = U = Person’s current gender identity is unknown
4.2
COUNTRY OF BIRTH
• Select first from boxes provided:
US
Other/US dependency (please specify)
• For patients born in US dependencies, specify from the following table:
US dependencies
American Samoa
Pacific Trust Territories
Guam
Palau
Johnston Atoll
Puerto Rico
Mariana Islands
Ryukyu Islands
Marshall Islands
Swan Islands
Micronesia
US Virgin Islands
Midway Islands
Wake Island
Navassa Island
4.9
ETHNICITY
• Regardless of the presence of race or absence of any information, collect data on ethnicity.
• As of January 2003, the US Office of Management and Budget (OMB) required that race and
ethnicity (Hispanic, non-Hispanic) for a person be collected as separate variables.
• A wide variety of ethnicities may be selected from legal values available in CDC-supplied
software. These ethnicities and codes are documented in the eHARS Technical Reference
Guide.
4.11 RACE
• As of January 2003, the US Office of Management and Budget (OMB) required that systems
collect multiple races for a person (OMB Policy Directive 15 updated standards); at a
minimum, collect data on the following categories:
• American Indian or Alaska Native
• Asian
• Black or African American
• Native Hawaiian or Other Pacific Islander
• White
• A wide variety of race categories may be selected from legal values available in CDCsupplied software. These races and codes are documented in the eHARS Technical Reference
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Guide.
5.0 RESIDENCE AT DIAGNOSIS
• Residence may be identical to that listed above in Patient Identification, unless otherwise
noted in the chart.
• For HIV, stage 1-2 case reports, enter residence at the time of the first positive confirmatory
test for HIV infection.
• If a diagnostic test result is not available, enter patient’s residence at the date of physician
diagnosis of HIV infection.
• For HIV, stage 3 (AIDS) case reports, enter patient’s residence at the date of the first AIDSdefining clinical condition or the date of the first immunologic marker that reaches AIDSdefining thresholds.
Residence assignment can be problematic for patients who:
• Have multiple residences
• Are on vacation
• Reside at a school
• Are foster children
• Are members of the armed forces
• Are institutionalized in correctional or other types of facilities
• Are foreign to the United States
• Are US citizens diagnosed abroad
RESIDENCE, INCARCERATED
• Enter home of record for sites of relatively brief incarceration such as county jails.
• For patients who are incarcerated in state or federal correctional facilities at the time of
diagnosis, record the correctional facility’s address.
• For patients incarcerated in city or county jails, record home address; enter jail address
only after unsuccessful search for address of patient’s home of record.
RESIDENCE, HOMELESS
• For homeless patients, enter the address that most accurately describes where they stay—
including a shelter address if applicable.
• People without a usual residence should be reported by the jurisdiction where they were
staying at the time of diagnosis.
For further guidance about residency assignment, see Technical Guidance for HIV Surveillance
Programs, Volume I: Policies and Procedures, Case Residency, Case Residency Assignment.
6.0 STATE/LOCAL USE ONLY
6.1
PHYSICIAN’S NAME
• If the test was provided as part of a visit to a health department, an STD clinic, an HIV
counseling and testing site, or other facility where no single individual is responsible for
medical management of the patient, leave this space blank and complete the “FACILITY OF
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DIAGNOSIS” section (Section IV of the CRF), appropriately.
7.0 FACILITY OF DIAGNOSIS
7.2
FACILITY NAME
• For HIV, stage 1 and stage 2 case reports, enter the name of the facility where the patient first
had blood drawn and was given a diagnosis of HIV infection.
• If test results are not in the medical record, enter the name of the facility where the patient’s
HIV infection was diagnosed and documented by the health care provider.
• For HIV, stage 3 (AIDS) case reports, enter the name of the facility where the patient’s
AIDS-defining clinical condition was first diagnosed, or a CD4 count below 200 cells/µL or a
CD4 percentage below 14 was documented, whichever came first.
• Enter facility/physician name uniformly to prevent the occurrence of multiple names for a
given facility.
• If a physician name is listed without a facility name, enter physician name.
8.0
PATIENT HISTORY
• Surveillance staff has found such information within charts at discharge summary, history
and physical, social service notes, counseling and testing notes, and STD diagnosis notes.
• Where not explicitly annotated, contact patient’s provider about risk factor information.
• See Technical Guidance for HIV Surveillance Programs, Volume I: Policies and Procedures,
Risk Factor Ascertainment, Risk Factor Ascertainment Procedures, Epidemiologic FollowUp for further guidance on risk factor data collection.
• This information can be difficult to find, particularly if the patient has not been interviewed.
States should have risk factor ascertainment procedures tailored to their jurisdictions.
8.5
HETEROSEXUAL RELATIONS WITH ANY OF THE FOLLOWING:
8.5.3 PERSON WITH HEMOPHILIA/COAGULATION DISORDER WITH DOCUMENTED
HIV INFECTION
• They do not include other bleeding disorders, such as thrombocytopenia, treatable by
platelet transfusion.
• If only a transfusion of platelets, other blood cells, or plasma was received by the
partner, then select “No.”
• Select “Yes” for the field labeled 5.5.4 about transfusion recipient if the partner was
also known to be HIV infected.
• Refer to Protocol for Evaluation of Identification and Follow-up of Cases of Public
Health Importance at http://www2a.cdc.gov/hicsb/docs/COPHI_Protocol.pdf for
more information. COPHI is also covered in Technical Guidance for HIV
Surveillance Programs, Volume I: Policies and Procedures, Risk Factor
Ascertainment, Cases of Public Health Importance (COPHI).
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10.0 CLINICAL
10.1 The following box is an excerpt from the 2008 case definition available
at: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5710a2.htm
AIDS-Defining Conditions
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Bacterial infections, multiple or recurrent*
Candidiasis of bronchi, trachea, or lungs
Candidiasis of esophagus†
Cervical cancer, invasive§
Coccidioidomycosis, disseminated or extrapulmonary
Cryptococcosis, extrapulmonary
Cryptosporidiosis, chronic intestinal (>1 month's duration)
Cytomegalovirus disease (other than liver, spleen, or nodes), onset at age >1 month
Cytomegalovirus retinitis (with loss of vision)†
Encephalopathy, HIV related
Herpes simplex: chronic ulcers (>1 month's duration) or bronchitis, pneumonitis, or
esophagitis (onset at age >1 month)
Histoplasmosis, disseminated or extrapulmonary
Isosporiasis, chronic intestinal (>1 month's duration)
Kaposi sarcoma†
Lymphoid interstitial pneumonia or pulmonary lymphoid hyperplasia complex*†
Lymphoma, Burkitt (or equivalent term)
Lymphoma, immunoblastic (or equivalent term)
Lymphoma, primary, of brain
Mycobacterium avium complex or Mycobacterium kansasii, disseminated or
extrapulmonary†
Mycobacterium tuberculosis of any site, pulmonary,†§ disseminated,† or extrapulmonary†
Mycobacterium, other species or unidentified species, disseminated† or extrapulmonary†
Pneumocystis pneumonia†
Pneumonia, recurrent†§
Progressive multifocal leukoencephalopathy
Salmonella septicemia, recurrent
Toxoplasmosis of brain, onset at age >1 month†
Wasting syndrome attributed to HIV
* Only among children aged <13 years. (CDC. 1994 Revised classification system for human immunodeficiency
virus infection in children less than 13 years of age. MMWR 1994;43[No. RR-12].)
†
Condition that might be diagnosed presumptively.
§
Only among adults and adolescents aged >13 years. (CDC. 1993 Revised classification system for HIV infection
and expanded surveillance case definition for AIDS among adolescents and adults. MMWR 1992;41[No. RR-17].)
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The 1993 case definition describes many of these AIDS –defining conditions (e.g. opportunistic
infections), available at http://www.cdc.gov/mmwr/preview/mmwrhtml/00018871.htm:
Diagnostic methods for diseases indicative of AIDS
Cryptosporidiosis, Isosporiasis, Kaposi’s sarcoma, Lymphoma, Pneumocystis carinii
pneumonia, Progressive multifocal leukoencephalopathy, Toxoplasmosis, Cervical cancer:
Microscopy (histology or cytology).
Candidiasis: Gross inspection by endoscopy or autopsy or by microscopy (histology or
cytology) on a specimen obtained directly from the tissues affected (including scrapings from
the mucosal surface), not from a culture.
Coccidioidomycosis, Cryptococcosis, Cytomegalovirus, Herpes simplex virus, Histoplasmosis:
Microscopy (histology or cytology), culture, or detection of antigen in a specimen obtained
directly from the tissues affected or a fluid from those tissues.
Tuberculosis, Other mycobacteriosis, Salmonellosis: Culture.
HIV encephalopathy (dementia): Clinical findings of disabling cognitive or motor dysfunction
interfering with occupation or activities of daily living, progressing over weeks to months, in
the absence of a concurrent illness or condition other than HIV infection that could explain the
findings. Methods to rule out such concurrent illness and conditions must include cerebrospinal
fluid examination and either brain imaging (computed tomography or magnetic resonance) or
autopsy.
HIV wasting syndrome: Findings of profound involuntary weight loss of greater than
10% of baseline body weight plus either chronic diarrhea (at least two loose stools per day for
greater than or equal to 30 days), or chronic weakness and documented fever (for greater than
or equal to 30 days, intermittent or constant) in the absence of a concurrent illness or condition
other than HIV infection that could explain the findings (e.g., cancer, tuberculosis,
cryptosporidiosis, or other specific enteritis).
Pneumonia, recurrent (more than one episode in a 1-year period), acute (new x-ray evidence
not present earlier) pneumonia diagnosed by both: a) culture (or other organism—specific
diagnostic method) obtained from a clinically reliable specimen of a pathogen that typically
causes pneumonia (other than Pneumocystis carinii or Mycobacterium tuberculosis), and b)
radiologic evidence of pneumonia.
•
Accept any method that the clinician considers diagnostic.
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