Supporting Statement A 11-22-2006

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

Coordinating Center for Infectious Diseases, Mail Stop G-23

Atlanta, Georgia 30333

HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1)

RAPID TESTING LABORATORY PRACTICES QUESTIONNAIRE FOR

NATIONAL AND INTERNATIONAL PARTICIPANTS

MPEP Identification No.: □□□□□

Facility/Testing Site Name: _________________________________________________

Street:___________________________________________________________________

City:_________________________________________

State/Province:___________________ ZIP /Postal Code:_____________________
Country:____________________________

Telephone No.: (______)_________-________Fax No.: (_____)_______-___________

E-mail Address: ________________________________________________________________________

Person completing form:

Name:_____________________________________________________________

Title: ________________________________________________________

Public reporting of this collection of information is estimated to average 20 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/ATSDR Reports Clearance Officer; 1600 Clifton Road NE, MS D-74, Atlanta, GA 30333; ATTN: PRA (0920-0595)

RETURNING THE QUESTIONNAIRE BOOKLET

PLEASE NOTE:

If you have entered and submitted your answers online,

Please DO NOT return this booklet!

DEADLINE FOR SUBMISSION: ______________ __, 2006

The website for online data submission of results is:

https://www.phppo.cdc.gov/mpep/results/login.aspx

You will need your MPEP identification number and password.

For those laboratories that choose to submit their answers on paper, an addressed envelope has been provided to mail the completed booklet to the MPEP. If you use the envelope provided, please mail your questionnaire booklet so that it reaches the MPEP Survey Coordinator at Constella Group, Inc. by the deadline indicated on the cover. If you use your own envelope, please send your questionnaire by the deadline to:

MPEP Survey Coordinator

Constella Group, Inc.

3 Corporate Blvd.

Suite 600

Atlanta, GA 30329

If you have any questions about submitting your questionnaire, please contact the

HIV Rapid Testing Project Coordinator, Leigh Vaughan:

telephone (404) 718-1005

email LVaughan@cdc.gov

MPEP Identification No. □□□□□

1. a) Please indicate the primary classification of your facility/testing site.
(Check one primary classification.)

□ Blood/plasma donor center □ HMO

(includes mobile units/vans used □ HIV Counseling and testing site/Clinic site

for donor blood collection) □ HIV Counseling and testing site/Field site

□ Drug use treatment center □ STD clinic

□ Family planning center Health dept: □ State/Province □ Other

□ Community based organization (CBO) □ Independent laboratory

□ Medical examiner/Coroner’s office □ Military (other than hospital)

□ Physician office □ Mobile unit/van (other than blood donor donation)

□ Oral health □ Hospice

□ Correctional facility/prison

Hospital (Indicate all applicable sections/locations within the hospital, as listed below:)

□ Admissions □ Blood Bank □ Central Laboratory

□ Emergency Room □ Labor/Delivery □ Ward/Floor

□ Employee health/infection control □ Other Hospital Section (specify) _________

□ Other testing site classification (specify):____________________________

b) Which of the following services does your organization provide? (Check all that apply.)

□ Medical care for people with HIV/AIDS

□ Social services for people with HIV/AIDS

□ HIV/AIDS prevention and education

□ Reproductive health

□ STD treatment/prevention

□ Maternal and child health

□ Mental/behavioral health

□ Hemophilia care

□ Comprehensive/general health clinic

□ Drug treatment

□ Housing assistance

□ Food bank

□ Other (please specify): _______________________________________________

1. c) Does your facility currently perform HIV rapid testing?

□ Yes, go to question 1e

□ No, please answer 1d and return your survey.

d) If your facility does not perform HIV rapid testing, why not?

□ Our facility is in a low prevalence area

□ Fears about test performance such as false positives

□ Lack of funding to purchase tests

□ Lack of interest

□ Other: ____________________________________

e) When did your facility begin to perform HIV rapid testing?

DATE: year □□□□

month (circle one) Jan Feb Mar Apr May June July Aug Sept Oct Nov Dec
□ date unknown, but > 5 years

□ date unknown

2. a) For what purpose(s) do you offer HIV rapid testing? (Check all that apply.)

□ Initial screen for diagnosis

□ Voluntary HIV testing (outpatients/clients)

□ Testing pregnant women of unknown HIV status at the time of delivery

□ For making decisions on post-exposure treatment for healthcare workers after

an accidental exposure

□ Emergency room screening

□ Other ______________________________

b) What is the target population for your rapid testing program?

Any client/patient who requests an HIV test □Yes □No

Any high school/college student □Yes □No

Any high risk client/patient □Yes □No

Certain types or categories of high risk client □Yes □No

If “Yes” to high risk client/patients, please specify (Check all that apply):

□ Gay/bisexual men or men who have sex with men

□ High risk women (e.g., sex workers)

□ Injection drug users

□ Adolescents

□ Homeless individuals

□ African Americans

□ Hispanic or Latino

□ Other (please specify): _________________________________________________

c) Approximately how many unique clients does your organization serve per year, across all

programs, onsite and offsite? ____________________________

2. d) Approximately what percentage of clients/patients at your organization
(round to nearest whole number):

Percent Don’t know*

Have incomes at or below the Federal poverty level^§? ______ ____

Are African American? ______ ____

Are Hispanic or Latino? ______ ____

Are White/Caucasian? ______ ____

Are HIV-positive? ______ ____

* information not available to laboratory

^§ Note: The federal poverty guideline is $9,570 for a 1-person household (HH), $12,830 for a 2-person HH,

$16,000 for a 3-person HH, and $19,350 for a 4-person HH)

e) Who PRIMARILY funds your testing site? (Check only ONE BEST answer)

□ CDC funded □ Federal, other than CDC

□ State/Province funded □ Private, non-profit

□ County, city or other government □ Private, for profit

(non-federal, non-state) □ Other (please specify):________________

3. a) Of all HIV testing performed in your facility over the past year, what percentage

was performed using HIV rapid test kits?

□ <5% □ 21-30% □ 61-74%

□ 6-10% □ 31-40% □ 75-99%

□ 11-15% □ 41-50% □ 100%

□ 16-20% □ 51-60%

b) How many client/patient specimens were tested using HIV rapid tests in your

facility during the most recent representative MONTH?

_________ number of specimens per MONTH

c) Of the specimens reported in 3b above, how many were initially reactive

(preliminary positive) during the same most recent representative MONTH?

_________ total number of initially

reactive (preliminary positive)

specimens per MONTH

d) Of the above (see answer 3c) initially reactive (preliminary positive) HIV rapid test results for which a confirmatory test was performed, how many were confirmed as positive?

_________ OR □ Confirmatory testing is not required

□ We do not perform confirmatory testing

□ We have not had any reactive (preliminary positive)

HIV rapid test results

□ N/A – client is referred elsewhere for confirmatory

testing (results unknown)

3. e) In the last 6 months, how many persons received preliminary positive results,

but did not return for confirmatory test results?

________ # of persons with initially ________ total # of persons not

reactive results returning for confirmatory results

□ N/A, we do not require confirmatory testing.

□ N/A, persons are sent elsewhere for confirmatory testing and

we do not receive those results.

□ No information available to us on confirmatory testing.

f) If HIV screening tests other than rapid tests are offered in your facility, what percentage of patients/clients in the last 6 months with preliminary positive results from these other tests do

not return for confirmatory results?

□ N/A, other HIV tests are not performed in our facility.

□ N/A, confirmatory testing is not required for our other (not rapid) HIV screening test(s).

□ N/A, persons sent elsewhere for confirmatory testing and we do not receive test results.

□ Don’t know; no information available on confirmatory testing for our other (not rapid) HIV

screening test(s).

4. a) Does your facility provide anonymous HIV rapid testing?

□ Yes
□ No

b) Does your facility have procedures for protecting the confidentiality of HIV results?

□ Yes

□ No

5. What test kit(s) do you currently use for HIV rapid testing? (Check all that apply.)

Abbott:	□	(0101)	Determine HIV-1/2		Genelabs Diagnostics:	□	(0601)	HIV-Spot
Bio-Rad:	□ □	(0301) (0302)	Multispot HIV-1/HIV-2 Genie II HIV-1/HIV-2		J. Mitra & Co. Ltd:	□	(1301)	HIV- TRIDOT
Chembio	□ (0401) □ □	(0401) (0402) (0403)	Sure Check HIV (previously Hemastrip HIV 1/2) HIV 1/2 Stat-Pak (Cassette) HIV 1/2 Stat-Pak (Dipstick)		OraSure:	□ □	(0801) (0802)	OraQuick Rapid HIV-1 Ab Test OraQuick ADVANCE Rapid HIV-1/2 Antibody test
Efoora :	□	(1201)	HIV Rapid Test		Trinity Biotech:	□	(0901)	Capillus HIV
Fujirebio:	□	(0501)	Serodia-HIV-1/2			□	(0902)	SeroCard HIV
	□	(0502)	Espline HIV-1/2			□	(0903)	Uni-Gold HIV
MedMira:	□	(0701)	Reveal G2 Rapid HIV-1 Antibody Test			□	(0904)	Uni-Gold Recombigen HIV
	□	(0702)	Reveal Rapid HIV-1 Antibody Test		Other (please specify both	□	(9900)	_________________________ _________________________
	□	(0703)	MedMira Rapid HIV Test (Canada only)		manufacturer & kit)

6. What sample type(s) do you currently use for HIV rapid testing? (Check all that apply.)

□ Serum □ Whole blood, finger-stick

□ Plasma □ Whole blood, venous

□ Oral fluid (from swabbing gums) □ Other (please specify): _______________________

7. a) Where are specimens collected and HIV rapid testing performed? (Check one best answer.) Please note: ON-SITE = within our facility

OFF-SITE = outside our facility; e.g., outreach, mobile units/vans, & other facilities

□ Specimens Collected ON-SITE and Testing performed ON-SITE

□ Specimens Collected ON-SITE & OFF-SITE and Testing performed ON-SITE

□ Specimens Collected ON-SITE & OFF-SITE and Testing performed ON-SITE & OFF-SITE

□ Specimens Collected OFF-SITE and Testing performed ON-SITE

□ Specimens Collected OFF-SITE and Testing performed OFF-SITE

□ Specimens Collected OFF-SITE and Testing performed ON-SITE & OFF-SITE

b) For Hospitals only: In what hospital setting are specimens collected? (Check all that apply.)

(Indicate all applicable sections within the hospital, as listed below)

□ Admissions □ Blood Bank □ Central Laboratory

□ Emergency Room (ER) □ Labor/Delivery □ Ward/Floor

□ Employee health/infection control □ Other Hospital Section (specify) __________

c) For Hospitals only: In what hospital setting are specimens tested? (Check all that apply.)

(Indicate all applicable sections within the hospital, as listed below)

□ Admissions □ Blood Bank □ Central Laboratory

□ Emergency Room (ER) □ Labor/Delivery □ Ward/Floor

□ Employee health/infection control □ Other Hospital Section (specify) __________

Note: Question 7d is ONLY for sites that collect specimens off-site for HIV rapid testing.

d) If you perform HIV rapid testing on specimens collected off-site (outside your facility),

please indicate where these specimens are collected. (Check all that apply.)

□ Blood/plasma donor center □ Correctional facility

(includes mobile units/vans used □ HMO

for donor blood collection) □ HIV Counseling and testing site

□ Drug use treatment center □ STD Clinic

□ Family planning center □ Health Department

□ Community Based Organization (CBO) □ Independent Laboratory

□ Medical Examiner/Coroner’s office □ Military (Other than Hospital)

□ Physician Office □ Mobile Unit/Van (other than blood donor donation)

□ Other off-site collection site (specify):_________________________________________

7. e) In which off-site settings does your organization perform rapid HIV tests?

(Check all that apply.)

□ No off-site settings

□ In a mobile facility (e.g., van)

□ In stores

□ In booths, e.g., at a health fair or festival

□ In bars or clubs

□ In bathhouses

□ On the street

□ Other setting(s) (please specify): ________________________________________

8. To detect HIV infection, do you currently perform a test in your facility other than an

HIV rapid test?

□ No Yes: (Check all that apply.)

□ Enzyme Immunoassay (EIA)

□ Western blot

□ Immunofluorescence assay

□ Other (please specify): ____________________

9. Has HIV rapid testing replaced some other method of HIV testing in your facility?

Please note: This does not refer to changing to another HIV rapid test method.

□ Yes. Specify method: □ EIA EIA kit name: _______________________________

□ Western blot (WB) WB kit name: ___________________

□ Other HIV test: ___________________________________

□ No

□ Do not know

10. Who performs HIV rapid testing in your facility on a regular basis? (Check all that apply.)

□ Physician

□ Physician Assistant

□ Nurse Practitioner

□ Person with M.S. or Ph.D. in medical or laboratory science

□ Person with Bachelors of Science/Arts in clinical laboratory science,

chemistry, biology, physics, immunology, microbiology

□ Person with Associate Degree

□ High School Graduate (with no post graduate education)

□ Medical Technologist (MT) or Clinical Laboratory Scientist/Specialist (CLS)

□ Medical Technician

□ Medical Assistant other than Medical Technologist/Technician

□ Nurse (RN/LPN)

□ Volunteer with formal medical/laboratory training

□ Volunteer with no formal medical/laboratory training

□ HIV counselor

□ Phlebotomist

□ Other (please specify): ___________________________________

11. a) How many staff in your organization are trained to do HIV rapid tests? ___________

b) What type of training is required for personnel performing HIV rapid testing in your

facility/testing site? (Check all that apply.) Please round to nearest whole numbers.

□ No training required. Go to Question 11d

□ Training by test kit manufacturer representative

Length of training: ______ hours

□ In-house training (conducted by your own facility personnel or institution)

Length of training: ______ hours

□ Training by State Health Department

Length of training: ______ hours

□ Course given by CDC or other federal agency

Length of training: ______ hours

□ Personnel must test and pass a proficiency/performance evaluation sample panel

before testing patient/client specimens.

Minimum number of samples tested:

□ Other type of training (please specify): ___________________________________

c) What is covered in the HIV RT training?

□ Reading package insert □ External quality assessment (performance

evaluation or proficiency testing [PT])

□ Practice test □ Quality Control (QC) issues

□ Standard operating procedures □ Other _____________________________

d) Is there a ‘site-specific’ Standard Operating Procedure (SOP) manual for rapid testing at the

testing site?

□ Yes

□ No

If not, why not? (Choose ONE BEST answer.)

□ Do not have an SOP for HIV RT in our facility.

□ Not familiar with SOPs.

□ We have an SOP, but it is not posted or located at the testing site.

□ We are testing in an outreach site where an SOP is inconvenient or could be

intimidating to clients/patients.

□ Other: ________________________________________________________

12. a) Is confirmatory testing performed (either in your facility or another facility) on

initially reactive (preliminary positive) HIV rapid tests?

□ Yes

□ No, Go to question 12f (page 12)

12.b) Many laboratories/testing sites use multiple tests simultaneously or in a step-wise fashion to derive an initially reactive (preliminary positive) result and/or a confirmed positive result. What is the typical algorithm, or order of tests, you use in your laboratory/testing site for HIV rapid testing and confirmatory testing? Please complete the table below by placing an ‘X’ in the boxes that correspond to your algorithm or order of tests. Check only one box for each step (row) in your algorithm. If you use less than 5 steps, leave those rows blank. For help in completing the table, please refer to the EXAMPLE in the box below of how one laboratory completed this table based on its testing algorithm.

The following is an EXAMPLE of how to complete the table given a particular scenario.

STEP 1: A patient specimen is tested using one rapid test kit. The result is reactive.

STEP 2: Specimen from the same patient is run in a second rapid test from a different manufacturer. The result is reactive.

STEP 3: Specimen from the same patient is sent to another facility to be run in Western blot for confirmation. The result is confirmed positive.

Two HIV Two HIV

Sequence One HIV rapid tests, rapid tests, 2^nd/3^rd HIV 2^nd/3^rd HIV EIA EIA WB WB IFA IFA Other test* Other test*

of Tests Rapid simultaneously simultaneously rapid test rapid test our other our other our other our other

Performed Test same test kit different kits same test kit different kit facility facility facility facility facility facility facility facility

1st step [X ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ]

2nd step [ ] [ ] [ ] [ ] [X ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ]

3rd step [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [X ] [ ] [ ] [ ] [ ]

4th step [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ]

5th step [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ]

*Other HIV test, please specify:                                                                                               

Two HIV Two HIV

Sequence One HIV rapid tests, rapid tests, 2^nd/3^rd HIV 2^nd/3^rd HIV EIA EIA WB WB IFA IFA Other test* Other test*

of Tests Rapid simultaneously simultaneously rapid test rapid test our other our other our other our other

Performed Test same test kit different kits same test kit different kit facility facility facility facility facility facility facility facility

1st step [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ]

2nd step [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ]

3rd step [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ]

4th step [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ]

5th step [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ]

*Other HIV test, please specify:                                                                                               

12.c) Please complete the table below to show the algorithm you use when the secondary or confirmatory test result is negative or indeterminate (IND) AFTER an initially reactive (preliminary positive) result. What is the typical algorithm, or order of tests, you use in your laboratory/testing site for HIV rapid testing and confirmatory testing? Please complete the table below by placing an ‘X’ in the boxes that correspond to your algorithm or order of tests. Check only one box for each step (row) in your algorithm. If you use less than 5 steps, leave those rows blank. For help in completing the table, please refer to the EXAMPLE in the box below of how one laboratory completed this table based on its testing algorithm.

The following is an EXAMPLE of how to complete the table given a particular scenario.

STEP 1: A patient specimen is tested using one rapid test kit. The result is reactive.

STEP 2: Specimen from the same patient is run in a second rapid test from a different manufacturer. The result is negative

STEP 3: Specimen from the same patient is run in a third rapid test from a different manufacturer. The result is positive..

STEP 4: Specimen from the same patient is sent to another facility to be run in Western blot for confirmation. The result is confirmed positive.

Two HIV Two HIV

Sequence One HIV rapid tests, rapid tests, 2^nd/3^rd HIV 2^nd/3^rd HIV EIA EIA WB WB IFA IFA Other test* Test

of Tests Rapid simultaneously simultaneously rapid test rapid test our other our other our other our or other Outcome

Performed Test same test kit different kits same test kit different kit facility facility facility facility facility facility facility (Result)

1st step [X ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] Positive

2nd step [ ] [ ] [ ] [ ] [X ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] Neg/IND

3rd step [ ] [ ] [ ] [ ] [X ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] Positive

4th step [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [X ] [ ] [ ] [ ] Positive

5th step [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ]

*Other HIV test, please specify test and location (our facility or other facility):                                                                                               

Two HIV Two HIV

Sequence One HIV rapid tests, rapid tests, 2^nd/3^rd HIV 2^nd/3^rd HIV EIA EIA WB WB IFA IFA Other test* Test

of Tests Rapid simultaneously simultaneously rapid test rapid test our other our other our other our or other Outcome

Performed Test same test kit different kits same test kit different kit facility facility facility facility facility facility facility (Result)

1st step [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [Positive]

2nd step [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ Neg/IND}

3rd step [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ]

4th step [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ]

5th step [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ]

*Other HIV test, please specify test and location (our facility or other facility)                                                                                               

12. d) What specimen type do you use to confirm initially reactive HIV rapid test

results? (Check all that apply.)

□ Serum

□ Plasma

□ Whole blood, finger-stick

□ Whole blood, venous

□ Oral fluid (from swabbing gums)

□ Dried blood spot

□ Other (please specify): _________________________

□ Do not know

e) Which of the following procedures are used to obtain a specimen for a confirmatory test?

(Check all that apply.)

□ Specimens are used from a prior blood draw.

□ New blood specimens are taken for the confirmatory test.

□ Oral fluid specimens (from swabbing gums) are taken.

□ Other: ______________________________________

□ Do not know

Note: The following three questions (12f – 12h) refer to specimens which give an

INITIALLY negative or indeterminate rapid test result.

f) If the initial HIV rapid test result is negative or indeterminate, is further HIV testing

performed for that client/patient (either in your facility or another facility)?

□ Yes

□ No, Go to question 13.

g) What specimen type do you use to perform further HIV testing after an initial negative or indeterminate HIV rapid test result? (Check all that apply.)

□ Serum

□ Plasma

□ Whole blood, finger-stick

□ Whole blood, venous

□ Oral fluid specimens (from swabbing gums)

□ Dried blood spot

□ Other (please specify): _________________________

□ Do not know

12. h) Please list in a step-wise fashion the steps you take when further HIV testing specimens which give a negative or indeterminate initial HIV rapid test result, by placing a number on the line corresponding to the step taken.

__1__ HIV rapid test – negative/indeterminate result

_____ 2^nd HIV rapid test

_____ EIA (Enzyme-linked Immuno Assay)

_____ Pooled HIV viral load (RNA) testing

_____ Other 1^st HIV test (please specify): _________________________

_____ Other 2^nd HIV test (please specify): _________________________

13. a) On average, how much time passes from collection of the specimen for HIV rapid

testing at your facility until preliminary positive results are reported (given) to the

client/patient? (Check only one.)

□ Less than 1 hour □ 4-8 hours

□ 1 hour □ 9-24 hours

□ between 1 and 2 hours □ 25-72 hours

□ 2-3 hours □ Other (please specify): ______________________________

b) On average, how much time passes from collection of the specimen for HIV rapid

testing at your facility until negative results are reported (given) to the client/patient?

(Check only one.)

□ Less than 1 hour □ 4-8 hours

□ 1 hour □ 9-24 hours

□ between 1 and 2 hours □ 25-72 hours

□ 2-3 hours □ Other (please specify): ______________________________

Reporting procedures for Initially Reactive (preliminary positive) HIV Rapid Tests

14. a) For Initially Reactive (preliminary positive ) HIV rapid tests, is this test result given the same day

to the patient/client (the person whose sample was tested for HIV)?

□ YES (go to question 14b)

□ NO (go to question 14c)

□ I don’t know (go to question 14d)

14. b) If “yes” to part (a): Who gives the result of the HIV rapid test to the patient/client

(the person whose sample was tested for HIV)? (Check all that apply.)

□ the person who performed the HIV rapid test.

□ the client/patient’s doctor or other health care professional responsible for the

client/patient (the person whose sample was tested for HIV).

□ a counselor (NOT the person who performed the test).

□ other (please specify):___________________________________________________

□ I don’t know

14. c) If “no” to part (a), (Check all that apply.)

□ initially reactive (preliminary positive) HIV rapid test results are NOT reported to the

client/patient (the person whose sample was tested for HIV).

□ initially reactive (preliminary positive) HIV rapid test results are NOT reported directly to

the client/patient; initially reactive results are reported ONLY AFTER CONFIRMATION.

□ initially reactive results are reported to the client/patient’s physician or other health care provider.

□ initially reactive results are reported to employee/occupational health OR infection control.

□ OTHER initially reactive result reporting procedure(s), specified:_________________________

□ I don’t know.

14. d) Where do the reporting procedures for initially reactive (preliminary positive) HIV rapid tests occur?

(Check all that apply.)

□ in our facility, in the department where HIV rapid testing is performed

□ at another area of our facility (NOT the site/department of HIV rapid testing)

□ externally (NOT at our facility)

□ I don’t know

14. e ) Do you have the same test result reporting procedures for all Reactive (preliminary positive)

HIV rapid tests? (Check only one.)

□ Yes

□ No, our result reporting procedures depend on the purpose for which

the HIV rapid test is ordered.

□ I do not know the reporting procedures for reactive (preliminary positive) HIV rapid tests

Reporting procedures for NON-Reactive HIV Rapid Test results

15. a) For NON-Reactive (Negative ) HIV rapid tests, is this test result given the same day to the

patient/client (the person whose sample was tested for HIV)?

□ YES (go to question 15b)

□ NO (go to question 15c)

□ I don’t know (go to question 15d)

15. b) If “yes” to part (a): Who gives the result of the HIV rapid test to the patient/client

(the person whose sample was tested for HIV)? (Check all that apply.)

□ the person who performed the HIV rapid test.

□ the client/patient’s doctor or other health care professional responsible for the

client/patient (the person whose sample was tested for HIV).

□ a counselor (NOT the person who performed the test).

□ other (please specify):___________________________________________________

□ I don’t know.

15. c) If “no”, please check all that apply:

□ non-reactive (negative) HIV rapid test results are NOT reported to the

client/patient (the person whose sample was tested for HIV).

□ non-reactive results are reported to the client/patient’s physician or other health care provider.

□ non-reactive results are reported to employee/occupational health OR infection control.

□ OTHER non-reactive result reporting procedure(s), specified:_________________________

□ I don’t know.

15. d) Where do the reporting procedures for non-reactive (negative) HIV rapid tests occur?

(Check all that apply.)

□ in our facility, in the department where HIV rapid testing is performed

□ at another area of our facility (NOT the site/department of HIV rapid testing)

□ externally (NOT at our facility)

□ I don’t know

15. e ) Do you have the same test result reporting procedures for all non-reactive (negative)

HIV rapid tests? (Check only one.)

□ Yes

□ No, our result reporting procedures depend on the purpose for which the HIV rapid test is ordered.

□ I do not know the reporting procedures for non-reactive (negative) HIV rapid tests

PLEASE NOTE:

The following questions on referral procedures concern procedures by which the Client/patient

(the person whose sample was tested for HIV) is referred for follow-up health care, counseling, etc.

Referral Procedures (follow-up) for client/patients after having HIV Rapid testing

16. a) For Initially Reactive (preliminary positive ) HIV rapid tests, what is the typical referral procedure

for the patient/client (the person whose sample was tested for HIV)? (Check all that apply.)

□ No referral procedure (go to question 16b)

□ Refer client to health department

□ Refer to HIV counseling center (on-site or off-site)

□ Refer to the health care provider or physician

□ Refer to employee/occupational health or infection control

□ Client is given a list of HIV resources for care

□ Client arranges own follow-up care

□ Other (please specify): _____________________________________

b) For confirmed positive HIV rapid test results:

If a client/patient has a preliminary positive rapid test that is confirmed positive,

is there a formal or informal protocol to refer this client/patient for follow-up care

(medical, counseling, etc.)? (Check all that apply.)

□ No protocol in place – referral on a case-by-case basis

□ Yes, we have a protocol/procedure for referral.

If yes, which of the following does the protocol include? (Check all that apply.)

□ Referral of client to health department

□ Refer to HIV counseling center (on-site or off-site)

□ Refer to the health care provider or physician

□ Refer to employee/occupational health or infection control

□ Client is given a list of HIV resources for care

□ Client arranges own follow-up care

□ Other (specify): ________________________________________________

c) For NON-REACTIVE HIV rapid test results:

What is the typical referral procedure for the client/patient tested? (Check all that apply.)

□ No referral procedure

□ Refer to HIV counseling center (on-site or off-site)

□ Refer to the health care provider or physician

□ Refer to employee/occupational health or infection control

□ Other (please specify): _____________________________________

Counseling procedures for client/patients after having HIV Rapid testing

17. a) Does your facility/testing site provide onsite HIV counseling to clients/patients?

□ Yes

□ No

b) At your facility/testing site, who provides client/patient consultation for initially reactive (preliminary positive) HIV rapid testing results? (Check all that apply.)

□ No counseling/consultation provided □ Physician Assistant

□ Physician □ Nurse Practitioner

□ Psychologist □ RN/LPN

□ Counselor □ Lab Tech

□ Other (please specify): _____________________

18. a) Is there a procedure at your facility to report reactive (preliminary positive) HIV rapid testing

results to an outside entity for purposes of surveillance?

□ No; Go to Question 19

□ I do not know; Go to Question 19

□ Yes.

□ Yes, but only after the HIV rapid testing results are confirmed.

If “Yes”, is reporting for surveillance mandatory? □ Yes □ No

b) What is the typical HIV rapid testing results reporting procedure for the purposes of HIV

surveillance? (Check one best answer for each column.)

Preliminary positive/reactive results HIV positive/confirmed results

□ Report directly to Health Department □ Report directly to Health Department

□ Report to Health Department and □ Report to Health Dept. and

physician/health care provider simultaneously phys./health care provider simultaneously

□ Report to physician first; □ Report to physician first;

physician reports to Health Department physician reports to Health Department

□ Other (please specify): ________________ □ Other (please specify): _______________

□ Not reported □ Not reported

18. c) To which health department(s) do you report HIV rapid testing results?

(Check all that apply, for each column.)

Preliminary positive/reactive results HIV confirmed results

□ None □ None

□ Local □ Local

□ State/Provincial □ State/Provincial

□ Federal surveillance system □ Federal surveillance system

□ Ministry of Health/National health □ Ministry of Health/National health

authority authority

□ National Reference Laboratory □ National Reference Laboratory

□ Other (specify): _______________ □ Other (specify): _______________

□ N/A – client is referred elsewhere for

confirmatory testing (results unknown)

19. a) How often does your facility/testing site run control material purchased separately (positive or negative controls not included in the test kit) when performing HIV rapid testing? (Check all that apply.)

□ Never; Go to Question 20

□ With each run, set or batch of patient tests

□ By each new operator prior to testing client/patient specimens

□ When opening new lot number of test kits

□ When opening new box of test kits

□ Whenever new shipment of test kits is received

At periodic intervals:

□ With every shift change

□ Daily

□ Weekly

□ Monthly

□ After every _______ (number) tests; please round to nearest whole number.

□ Other _____________________________________

□ When the temperature of the test kit storage area falls outside the acceptable range stated

by the manufacturer

□ When the temperature of the testing area falls outside the acceptable range stated by the

manufacturer

b) What is the source of the above control material?

□ A different HIV rapid test kit

□ Purchased separately from same manufacturer as test kits

□ Purchased separately from different manufacturer

□ Prepared in-house

□ Other (please specify): ________________________________

20. a) In which external quality assurance (EQA) HIV rapid testing proficiency testing (PT)

or performance evaluation (PE) program(s) does your facility participate? (Check all that apply.)

□ None

□ CDC Model Performance Evaluation Program (MPEP)

□ College of American Pathologists (CAP)

□ American Association of Bioanalysts (AAB)

□ American Proficiency Institute (API)

□ New York State Department of Health Proficiency Program

□ Wisconsin State Laboratory of Hygiene Proficiency Testing Program

□ Other State Program (please specify): ________________________________

□ Provincial Program (please specify): ____________________________

□ National Program (please specify): _____________________________

□ Other (please specify): _______________________________________

b) If you are a U.S. testing site, does your site have a government-issued CLIA certificate of waiver

or another type of CLIA certificate that allows you to test? □ Yes □ No □ Not U.S. site

If yes, what type of CLIA certificate?

□ Certificate of waiver □ Registration certificate

□ Certificate of compliance □ Certificate for provider-performed microscopy

□ Certificate of accreditation

c) Who performs proficiency testing or performance evaluation testing for HIV rapid testing

in your testing site? (Check all that apply.)

□ Medical Technologist/Clinical Laboratory Scientist

□ Medical Technician

□ Person with BS/BA in laboratory science

□ HIV Counselor

□ Person with Associate Degree

□ Nurse/Nurse Practitioner

□ Other: _____________________________________________

21. a) Approximately how much does your facility charge to perform an HIV rapid test?

(Round off to nearest U.S. Dollar. Put $0.00 in the box if there is no charge.)

$

□ Typical charge:

□ Variable fee schedule: ___________________________________________

b) Do you accept insurance reimbursement only, so that there is no actual charge to the patient?

□ Yes

□ No

□ N/A – all testing is free (no charge)

□ I don’t know

22. a) In your opinion, what are the advantages and disadvantages of HIV rapid testing for

patient/clients, as compared to traditional, non-rapid HIV testing? (check all that apply)

□ In comparison to traditional HIV tests, rapid tests increase clients’ anxiety about HIV.

□ It is easy to explain the rapid test to clients with low literacy skills.

□ Clients may not feel prepared to receive HIV test results so quickly.

□ Rapid testing allows more people to know their HIV status.

b) In your opinion, what are the administrative advantages and disadvantages of

HIV rapid testing, as compared to traditional, non-rapid HIV testing? (check all that apply)

□ My organization’s administration encourages the use of rapid tests.

□ Rapid tests have been easily integrated into my organization.

□ Rapid test kits cost too much.

□ It is expensive to start up a rapid testing program.

□ It was difficult to design a rapid testing protocol for my organization.

□ Other: ________________________________________________________

c) In your opinion, what are the advantages and disadvantages of HIV rapid testing

when used in field settings such as mobile units/vans? (check all that apply)

□ It is difficult to maintain client confidentiality in field settings.

□ Test kit temperatures are hard to regulate in field settings.

□ It is challenging to read rapid test results in field settings.

□ Rapid HIV tests are more appropriate to use in the field than non-rapid HIV tests.

□ My organization is unable to provide confirmatory tests to clients in the field.

Thank you for your participation!

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