Sep 2013, v1.0

PMTCT Determine® Donation Program Progress Report and Order Form

Sep 2013, v1.0

Instructions To order a re-supply of Determine HIV Tests through the PMTCT Determine Donation Program you must first complete the following progress report on use of your last donation. After you have finished the report, you may proceed to place an order. When you are finished, please email your completed form and any related documentation to DetermineDonation@directrelief.org. If you have any questions about completing the form, please contact the PMTCT Determine Donation Program Administrator by email at DetermineDonation@directrelief.org or call Direct Relief-South Africa at +27 (11) 351 1287. For more information about the PMTCT Determine Donation Program, please visit www.directrelief.org/determine.

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PMTCT Determine® Donation Program

Progress Report

Sep 2013, v1.0

Part 1: Contact Details

Telephone Email

Organization Name

Street Address 2

Street Address 1

City

P.O. Box

First Name

Last Name

Title

Position

Primary Contact Person

Street Address 1

City

P.O. Box

Street Address 2

Email 2

Email 1

Mobile Telephone

Telephone

Date last donation was received at your facility: (DD/MM/YYYY)

Last Order

Date of submission for this report (DD/MM/YYYY)

Part 2: Reporting Period

This Report

This should be the end date of the Current reporting period.

This should be the end date of the Previous reporting period.

To (DD/MM/YYYY) From (DD/MM/YYYY)

Please indicate the time period during which the last order was utilized:

Country

Country

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PMTCT Determine® Donation Program

Progress Report

Sep 2013, v1.0

Number of sites that received Determine HIV Tests in the last donation:

Part 3: Program Scale

List of Active Sites Please submit a list of active sites in the Determine Donation Program with this progress report.Request a Site List Template from Direct Relief, or provide the list in Excel Spreadsheet. The minimum details must be provided: Site Name, Level of Facility, Region, District, Town/Village. * An active site is a health facility that has received Determine tests in the last calendar year.

PRODUCT DESCRIPTION UNIT

IN STOCK FROM PREVIOUS

REPORTING PERIOD

QUANTITY RECEIVED

DISTRIBUTED TO SITES USED

EXPIRED/LOST/DAMAGED*

REMAINING IN STOCK

Determine® HIV Tests Test

Part 4: Product Usage

Please report on the quantity of Determine HIV tests used during the period covered by this report. Enter cumulative data from all facilities involved in your program.

Please explain any lost, damaged, or expired tests. You may also use this space to comment on the quantities listed above:

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PMTCT Determine® Donation Program

Progress Report

Sep 2013, v1.0

NUMBER

Started antenatal care

Were offered HIV test counseling

Tested for HIV

Returned for HIV test results

Had an HIV-positive test result

Received Nevirapine single dose

Were referred for treatment

Were put on antiretroviral therapy (ART)

Number of Pregnant Women

Additional Information

NUMBER

Children who received Nevirapine single dose

Spouses of HIV-positive pregnant women who were tested for HIV

Spouses with an HIV-positive test result

Children (18 months and older) of HIV-positive mothers who were tested for HIV

Children (18 months and older) with an HIV-positive test result

Number of Family Members

Specify the treatment regimen:

Please add any additional information you might have to explain the figures on this page:

Part 5: Quantitative Outcomes

Does the data submitted above represent ONLY the results from the Determine tests provided through the donation program ? Yes No

If No, please explain how this data was collected:

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PMTCT Determine® Donation Program

Progress Report

Sep 2013, v1.0

New national guidelines that may have an influence on your PMTCT program:

Guidelines

Logistics

Additional Comments

Plans for expanding your PMTCT program:

Expansion

The following questions are not required but may help us better understand your program. Please provide information about the implementation of your PMTCT services and any changes since the last reporting period.

Part 6: Qualitative Outcomes

Reception, distribution, and storage of Determine HIV tests:

Health Medical Information System Record-keeping issues on patient data, product consumption data, and estimation of product needs:

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PMTCT Determine® Donation Program

Progress Report

Sep 2013, v1.0

Report Checklist

NEXT: Order Products Thank you for completing the Progress Report. If you would like to place an order, proceed to the Order Form on the next page. If you do not require any Determine HIV Tests at this time, please save your completed form and email it, along with any related documentation, to Direct Relief at DetermineDonation@directrelief.org.

Part 6: Qualitative Outcomes, page 6 Optional. Completing this section may help Direct Relief better understand the implementation of your PMTCT program.

Part 5: Quantitative Outcomes, page 5 This section is complete if you have provided figures on pregnant women and their spouses and children receiving care through your PMTCT services.

Part 4: Product Usage, page 4 This section is complete if you have fully reported the quantity of Determine HIV Tests used since the time of your last order, and reported the reason for any lost, damaged, or expired products.

Part 3: Program Scale, page 4 This section is complete if you have listed (or provided in a separate file, for large-scale distribution operations) the sites receiving Determine HIV Tests.

Part 2: Reporting Period, page 3 This section is complete if you have provided a time period during which the last order was utilized.

Part 1: Contact Details, page 3 This section is complete if you have provided the contact information of the person completing this form and the institution receiving the Determine HIV Tests.

PMTCT Determine® Donation Program Order Products

Sep 2013, v1.0 Page 8 of 13

Part 1: Request Products

Please indicate the quantities needed of each item below. Three accessory items are available for your use with the kits if needed for whole blood testing. Indicate number of months during which the requested products will be used:

PRODUCT DESCRIPTION UNIT QUANTITY

Determine® HIV Test 100 tests per kit

Kit = tests

Determine® EDTA Capillary Tubes 100 per box

Box = tubes

Determine® Lancets 100 per box

Box = lancets

Determine® Chase Buffer 1 Bottle per 100 tests

Bottle

Program Scale

Number of sites that will receive Determine tests in this order:

Please explain the rationale for the requested quantities of Determine tests. Use the text box below or attach any files that you think may help us better understand your projected product needs:

PMTCT Determine® Donation Program Order Products

Sep 2013, v1.0 Page 9 of 13

IMPORTANT! Please enter all information carefully, as it will be used on the shipping documents.

Part 2: Shipping Information

Ship-To Party/Consignee (Mandatory)

Telephone Email

Organization Name

Street Address 2

Street Address 1

City

P.O. Box

First Name

Last Name

Title

Position

Shipping Contact Person

Street Address 1

City

P.O. Box

Street Address 2

Email 2

Email 1

Mobile Telephone

Telephone

The Ship-to Party/Consignee is the entity that takes physical possession of the donated product at the airport of entry and is responsible for the customs clearance and arranging transportation to the recipient facility.

Preferred International Airport of Entry

Country

Country

PMTCT Determine® Donation Program Order Products

Sep 2013, v1.0 Page 10 of 13

IMPORTANT! Please enter all information carefully, as it will be used on the shipping documents.

Part 2: Shipping Information (continued)

Notify Contact Person

Notify Organization (Optional)

Telephone Email

Organization Name

Street Address 2

Street Address 1

City

P.O. Box

First Name

Last Name

Title

Position

Street Address 1

City

P.O. Box

Street Address 2

Email 2

Email 1

Mobile Telephone

Telephone

Only complete this if you have a notify party in addition to the Ship-to Party/Consignee. The Notify Party will receive the original shipping documents in lieu of the Ship-To Party.

Country

Country

PMTCT Determine® Donation Program Order Products

Sep 2013, v1.0 Page 11 of 13

Part 2: Shipping Information (continued)

Required Documents

The following documentation will be provided with every shipment:

1. Commercial Invoice

2. Packing List

3. Certificate of Gift Donation

4. Certificate of Analysis

5. Air Waybill

Note: All documents are in English.

Please indicate if additional documents are required by the customs authority in your country:

Please indicate if additional instructions are required by the customs authority in your country:

PMTCT Determine® Donation Program Order Products

Sep 2013, v1.0 Page 12 of 13

Donation of DETERMINE® HIV-1/2. The DETERMINE® HIV-1/2 rapid tests (“Tests”) supplied by Direct Relief to the program detailed in this report (“Program”) shall be used only in programs aimed at reducing the transmission of HIV-1 from mother to child. The use of the Tests in any other manner or for any other purpose is forbidden unless approved by Direct Relief in writing. The Program shall use the Tests only in accordance with approved product labeling and in accordance with the World Health Organization (WHO) Guidelines (RAPID HIV TESTS: Guidelines for Use in HIV Testing and Counseling Services in Resource-Constrained Settings, 2004).

The importation and use of the Tests by the Program may be subject to local regulatory and other governmental approvals and registrations. Where necessary, the Program has the responsibility to complete, maintain and bear the costs related to any importation requirements.

The Program agrees not to resell one or more of the Tests to any third party. The Program may not export the Tests to any other country.

The Program is responsible for the completion of all custom clearance formalities and any related costs. Upon request, Direct Relief will provide the Program with donation certificates that may be used to obtain tax waivers or exemptions. The Program shall implement and take all reasonable measures to prevent the diversion of the donated Tests to any third party or for any purpose.

The Program is responsible for the storage and handling of the Tests in accordance with the storage specifications stated in the Test package insert. The Program agrees to prepare and maintain an auditable record of the use of the Tests and, upon request by Direct Relief, submit periodic progress reports and other pertinent information regarding the use of the Tests and the number of Tests administered.

Direct Relief makes no warranties to the Program or any of the Program's patients or clients related to the Tests; or the administration, use, and interpretation of the tests. Direct Relief shall not be liable for any medical expenses or any direct or consequential damages resulting from any defect, failure, or malfunction of the Tests.

Your acceptance of the terms contained herein is a precondition to the supply of the Tests by Direct Relief to the Program and any violation of these terms shall entitle Direct Relief to cease, at its sole discretion, the supply of the Tests to the Program.

The Program agrees to report any safety or adverse event relating to the use or administration of the Test in accordance with the legal requirements in the country where the Program resides.

Any safety-related information and relevant documentation must be made available to Direct Relief, 27 S. La Patera Lane, Santa Barbara, CA 93117, without delay.

I have read and I agree to the terms and conditions of this offer.

Part 3: Terms and Conditions

PMTCT Determine® Donation Program Order Products

Sep 2013, v1.0 Page 13 of 13

Thank you for your Progress Report and Order.

Please save the form and email it and any related documentation to

Direct Relief at DetermineDonation@directrelief.org.

The Determine PMTCT Donation Project Manager at Direct Relief will

contact you by email within 5 business days to confirm receipt of your

report and order and request any clarifications that are needed.

Once approved, Direct Relief will provide the shipping documentation

and will advise of the estimated departure time for your donation.

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