Form 4 Laboratory Practices Questionnaire (LPQ)

Model Performance Evaluation Program (MPEP)

For HIV Rapid Testing

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention, Mail Stop G-23

National Center for Preparedness, Detection, and Control of Infectious Diseases

Atlanta, Georgia 30333

HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1)

RAPID TESTING LABORATORY PRACTICES QUESTIONNAIRE FOR

NATIONAL AND INTERNATIONAL PARTICIPANTS

WORKSHEET

To enter your results online, you will need:

1. Your MPEP I.D. number

2. Your Password

Enter results at: http://wwwn.cdc.gov/mpep/results/login.aspx

Person completing form:

Name:_____________________________________________________________

Title: ________________________________________________________

Public reporting of this collection of information is estimated to average 30 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-24, Atlanta, GA 30333; ATTN: PRA (0920-0595)

PLEASE DO NOT MAIL THIS FORM!!

The MPEP is currently ONLY accepting results online.

Please submit your results at:

http://wwwn.cdc.gov/mpep/results/login.aspx

If you have questions please contact:

the MPEP at 1-877-360-8502

OR

Leigh Vaughan, HIV-RT MPEP Project Coordinator

email: [email protected]

phone: 404-498-2246

DEADLINE FOR SUBMISSION: Month xx, 2010

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

□ Ambulance □ Hospice

□ Ambulatory surgery center □ Independent laboratory

□ Ancillary test site □ Industrial

□ Assisted living facility □ Insurance

□ Blood/plasma donor center □ Intermediate care facility

(includes mobile units/vans used □ Medical examiner/Coroner’s office

for donor blood collection) □ Military (other than hospital)

□ Community based organization (CBO) □ Mobile unit/van (other than blood donor donation)

□ Correctional facility/prison □ Nursing facility/ skilled nursing

□ Drug use treatment center □ Oral health

□ End stage renal disease dialysis □ Pharmacy

□ Federally qualified health center □ Physician office

□ Family planning center □ Other practitioner

Health dept: □ State/Province □ Other □ Public health laboratory

□ Health fair □ Rural health care clinic

□ HIV Counseling & testing/Clinic site □ School/student health service

□ HIV Counseling & testing/Field site □ STD clinic

□ HMO □ Tissue bank/repositories

□ Home health agency

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 2a

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

2. a) What is your purpose for offering HIV rapid testing? (Check all that apply.)

Screening for HIV infection:

□ All patient/clients seen in our facility

□ Initial screen for diagnosis

□ Prior to specific facility procedure(s) (e.g. surgery or labor & delivery)

□ 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 primary target population for your rapid testing program? (check only one)

□ All persons between ages 13-64 years

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

□ Adult women (ages 25-44 years)

□ Pregnant women

□ Injection or intravenous drug users

□ Adolescents (ages 10-24 years)

□ Persons who have had unprotected vaginal or anal intercourse with more than one partner,

exchange money or gifts for sex, or had unprotected sex with someone who might have HIV

□ Persons who have been diagnosed or treated for STDs, hepatitis, or tuberculosis

□ Homeless individuals

□ African Americans

□ Asian

□ Native Americans

□ Hispanic or Latino

□ Other (please specify):

□ NO specific target population _________________________________________________

c) Approximately how many clients does your HIV rapid testing site serve per year?

____________________________

d) Who PRIMARILY funds your testing facility? (Check all that apply)

□ 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) What is the average monthly testing volume of HIV rapid tests done at your testing site?

□ < 5 □ 61 to 90

□ 6 to 30 □ 91 to 99

□ 31 to 60 □ ≥ 100

b) Of the specimens reported in 3b above, what percent (%) were initially reactive

(preliminary positive)?

_________ % monthly average of initially reactive (preliminary positive) HIV rapid tests

c) 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)

d) Does you facility also use EIA (enzyme-linked immunoassay) as an HIV screening test?

□ No. Go to question # 4(a)
□ Yes. If yes, what percent (%) of patient/clients with reactive EIA results return for

their confirmatory test results?

□ 0 - 20%

□ 21 - 40%

□ 41 - 60%

□ 61 - 80%

□ 81 - 99%

□ 100%

□ 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.

□ Do not 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

patient results?

□ Yes

□ No

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

Abbott:	□		Determine HIV-1/2	Inverness Medical	□ □		Clearview HIV 1/2 Stat-Pak Clearview Complete HIV 1/2
Bio-Rad:	□ □		Multispot HIV-1/HIV-2 Genie II HIV-1/HIV-2	Genelabs Diagnostics:	□		HIV-Spot
Chembio:	□		Sure Check HIV (previously Hema-Strip HIV-1/2)	J. Mitra & Co. Ltd:	□		HIV- TRIDOT
Chembio:	□ □		HIV 1/2 Stat-Pak(Cassette) HIV 1/2 Stat-Pak(DIPSTICK)	OraSure:	□		OraQuick ADVANCE Rapid HIV-1/2 Antibody test
Efoora :	□		HIV Rapid Test	Trinity Biotech:	□		Capillus HIV-1/HIV-2
Fujirebio:	□		Serodia-HIV-1/2		□		SeroCard HIV
	□ □		Serodia-HIV SDF HIV 1/2 PA		□		Uni-Gold HIV
MedMira:	□ □		MiraCare HIV Test Reveal G3 Rapid HIV-1 Antibody Test		□		Uni-Gold Recombigen HIV
				Other: (please specify both	□		_________________________ _________________________
				manufacturer & kit)

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

Serum: □ fresh Plasma: □ fresh Whole blood: □ finger-stick

□ frozen □ frozen □ venous

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

7. a) Where are your HIV rapid testing specimens collected?

(Check one best answer.)

ON-SITE = within our facility

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

□ Specimens Collected ON-SITE

□ Specimens Collected OFF-SITE

□ Specimens Collected BOTH ON-SITE & OFF-SITE

b) Where do you perform your HIV rapid testing?

ON-SITE = within our facility

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

□ Specimens tested ON-SITE

□ Specimens tested OFF-SITE

□ Specimens tested BOTH ON-SITE & OFF-SITE

7. c) 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) __________

d) 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 7e is ONLY for sites that collect specimens off-site for HIV rapid testing.

e) 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):_________________________________________

f) In which off-site settings does your organization perform rapid HIV tests?

(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):_________________________________________

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 routinely performs HIV rapid testing at your facility on a regular basis?

(Check all that apply.)

□ Clinical Laboratory Scientist/Specialist (CLS)

□ HIV counselor

□ Medical Technologist (MT)

□ Medical Technician

□ Medical Assistant

□ Nurse (RN/LPN)

□ Nurse Practitioner

□ Phlebotomist

□ Physician

□ Physician Assistant

□ Volunteer with formal medical/laboratory training

□ Volunteer with no formal medical/laboratory training

Educational degrees:

□ Associate Degree

□ Bachelors of Science/Arts in in medical or laboratory science

□ High School Graduate (with no post graduate education)

□ MPH

□ M.S. in medical or laboratory science

□ Ph.D. in medical or laboratory science

□ Other (please specify): ___________________________________

11. a) How many staff at your facility perform HIV rapid testing? ______________

b) How many staff at your facility have received specific HIV rapid testing training?

___________

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

facility/testing site? (Check all that apply.)

□ No training required. Go to Question 11e

□ Training by test kit manufacturer representative

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

□ Training by State Health Department

□ Course given by CDC or other federal agency

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

before testing patient/client specimens.

□ Other type of training (please specify): ___________________________________

d) What is covered in the HIV RT training? (Check all that apply.)

□ Reading package insert □ External quality assessment (performance

evaluation or proficiency testing [PT])

□ Practice test □ Quality Control (QC) issues

□ Standard operating procedures □ Other _____________________________

e) 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.)

□ 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.

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

□ I am not familiar with SOPs.

□ 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 12g (page 14)

12. b) 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.

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

results? (Check all that apply.)

□ Dried blood spot

□ Oral fluid (from swabbing gums)

□ Plasma

□ Serum

□ Whole blood, finger-stick

□ Whole blood, venous

□ Do not know

□ Other (please specify): _________________________

f) 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 (12g – 12i) refer to specimens which give an

INITIALLY negative or indeterminate rapid test result.

g) If the initial HIV rapid test result is negative or invalid, is further HIV testing

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

□ Yes

□ No, Go to question 13.

h) What specimen type do you use to perform further HIV testing after an

initial negative or invalid HIV rapid test result? (Check all that apply.)

□ Dried blood spot

□ Oral fluid (from swabbing gums)

□ Plasma

□ Serum

□ Whole blood, finger-stick

□ Whole blood, venous

□ Do not know

□ Other (please specify): _________________________

12. i) 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

_____ 3^rd HIV rapid test

_____ EIA (Enzyme-linked Immuno Assay)

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

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

_____ Other 3^rd HIV test (please specify): _________________________

13. a) What is the turnaround time for obtaining an HIV rapid test result? (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): ______________________________

2. What is the amount of time for the total testing process (sample collection,

testing and reporting results to th patient/client)? (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/patient 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/patient is given a list of HIV resources for care

□ Client/patient 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 specific 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/patient 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/patient is given a list of HIV resources for care

□ Client/patient 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? (Check all that apply.)

□ Packaged in the HIV rapid test kit

□ Purchased separately from the same manufacturer as test kits

□ Purchased separately from a 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.)

□ American Association of Bioanalysts (AAB)

□ American Proficiency Institute (API)

√ CDC Model Performance Evaluation Program (MPEP)

□ College of American Pathologists (CAP)

□ National Program (please specify): _____________________________

□ New York State Department of Health Proficiency Program

□ Other State Program (please specify): ________________________________

□ Provincial Program (please specify): ____________________________

□ Wisconsin State Laboratory of Hygiene Proficiency Testing Program

□ Other (please specify): _______________________________________

□ None

2. 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? (Check only one)

□ 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 payment for the

HIV rapid test by the Client/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

client/patients, as compared to traditional, non-rapid HIV testing? (Check all that apply.)

advantages:

□ It is easy to explain the rapid test to client/patients with low literacy skills.

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

□ Other advantages: ________________________________________________________

disadvantages:

□ In comparison to traditional HIV tests, rapid tests increase client/patients’ anxiety about HIV.

□ Client/patients may not feel prepared to receive HIV test results so quickly.

□ Other disadvantages: ________________________________________________________

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.)

advantages:

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

□ Rapid tests have been easily integrated into my organization.

□ Other advantages: ________________________________________________________

disadvantages:

□ 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 disadvantages: ________________________________________________________

22c) 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.)

advantages:

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

□ Other advantages: ________________________________________________________

disadvantages:

□ It is difficult to maintain client/patient 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.

□ My organization is unable to provide confirmatory tests to client/patients in the field.

□ Other disadvantages: ________________________________________________________

Thank you for your participation!

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