Isibani: Request for Proposals

Isibani
Please note: this opportunity closing date has passed and may not be available any more.
Opportunity closing date: 
Thursday, 5 March, 2020
Opportunity type: 
Call for proposals

Request for Proposals
for the supply of 100 000 HIV Self Screening Test Kits
Bid Number: ISI2020-HSSTK

Isibani Development Partners is a South African-registered NGO, launched in 2011 to become a leading local technical assistance provider, systems strengthening and grants manager for health and social service in Southern Africa. Our programs focus is on HIV, TB, Non-Communicable diseases and Capacity development for community-based organization and government departments.
 
Isibani is inviting suppliers to submit proposals for the supply of HIV Self Screening Test Kits as per the following Terms of Reference:
 
SPECIFICATION FOR HIV SELF SCREENING TEST KITS (GLOBAL FUND SUPPORT)

Definition: The HIV self-screen test: Each subject is able to self-collect test specimen and perform the test according to only those materials provided with the IVD (for example, instructions for use, labels and other instructional materials).

1. Pre-Screen suitability

  • The test kit must appear on the WHO LIST OF PREQUALIFIED IN-VITRO DIAGNOSTIC PRODUCTS as a “HIV RDT for Self-testing” type of assay.
  • http://www.who.int/diagnosticslaboratory/evaluations/PQlist/en/
    • Proof of ISO13485-2016 certification (https://www.iso.org) or an equivalent quality management system recognised by a regulatory authority which is a member of Global Harmonization Task Force (GHTF)
    • Suppliers are required to adhere to Medicines and related substances Act, 1965 (Act No. 101 of 1965), as amended as per the Regulation relating to Medical Devices and In Vitro Diagnostic Medical Devices. Non-compliance with these conditions will invalidate the bid.
  • Manufacturers, distributors and wholesalers, as referred to in Section 22C(1)(b) of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), must obtain a licence for the manufacturing, importing, exporting, distribution and wholesaling of medical devices and IVDs, as issued by the South African Regulatory Authority.
  • Proof of the production, invoicing and shipping documents of a minimum of three different test kit batches / lot numbers must be provided.
  • Relevant documentation and/or proof must be provided as evidence of duration in the marketplace.
  • Suppliers must submit with the bid, on or before the closing date and time of bid evidence of the approved medical device establishment licence
  • In the event that an approved medical device establishment licence and/or registration certificate cannot be obtained from the South African Regulatory Authority, prior to the closing date and time of the bid, the bidder must submit evidence of application made to the South African Regulatory Authority, to be licensed as a medical device establishment (in the form of an Acknowledgement Letter received from the South African Regulatory Authority).
  • Upon such time that medical devices are called up for registration, via publication in the Government Gazette, suppliers, who have been licensed as medical device establishments must submit evidence of the approved registration certificate of the said medical device.
  • Evidence of application made to the South African Regulatory Authority, to register the said medical device (in the form of an Acknowledgement Letter received from the South African Regulatory Authority) will be required during the contract period if applicable.

2. The test kit must detect HIV 1 and HIV 2 antibodies simultaneously.
3.The testing should not be complex and must be completed in a minimum of three steps.
4. The test kit must be user-friendly i.e. easy to perform. 

  • Pictorial instructions for use (IFU) must be supplied with clear instructions for use with oral fluid sample only.  The instruction must be in English.

5.The test device must comprise synthetic peptides and/or recombinant proteins and detect for IgG and/or IgM.
6. Each test must have an IgG Control (validation) line.
7. Only the manufacturer’s original name of the test kit device will be accepted for the traceability of the test kit and reagents, packaging and labelling (i.e. NO OEM) Original equipment manufacturer.

  • Test kit batch / lot number and expiry date must appear on each test foil, box of tests and outer shipping carton.  Labelling should conform to GHTF Documents “Labelling and Instructions for Use for IVD Medical Devices”.
  • Additional equipment and developer solution required for the test must be provided including test stand, vial of developer solution and an IFU/Package Insert with version control.
  • The name of the test kit must be the same on the documentation submitted for the tender as it appears on the test device. The test device as well as the kit packaging should also have the same kit name.

8. The test kit must have high analytical sensitivity and specificity ( ≥ 99 % Sensitivity and ≥ 98% Specificity) in reputable Laboratory Evaluations.

9. The number of weak positives must be less than 5 %. A weak Positive is a known sample that gives a weak reaction on the HIV test strip when a band is significantly fainter or weaker than the procedural control observed.

10. The number of invalid results must be less than 5 %.

11. Inter-reader variability of test kits must be less than 5 %.  Inter-reader variability is analysed by two different operators who read the final results independently.

12. The storage temperature of the test kits and reagents should allow safe storage in any South African rural clinic that has no heating or refrigeration (safe to store between 2° C and 30° C).  Operating temperature should be room temperature ie. between 18° C and 26 ° C).

13. The maximum time duration for the test result must be 20 minutes or less for either positive or negative results. The IFU must indicate a specified incubation time duration. No duration ranges will be accepted e.g. 5-20 minutes is not acceptable. One incubation time duration is required.

14. The guaranteed shelf-life for the test and developer solution must be greater than 12 months on delivery at all delivery sites countrywide.

15. Training for one to two days must be provided by the supplier in the provinces prior to supplying test kits at the supplier’s cost including test kits used for demonstration purposes.

16. Training must also be provided to the other Government Departments and other users in the provinces at the suppliers’ cost including test kits used for demonstration purposes.

17. Suppliers must also be available to assist provinces with training as the need arises at the suppliers’ cost including test kits used for demonstration purposes.

18. Post-Market Surveillance: It is compulsory for supplier/s to participate in the Post Market Surveillance as follows:

  • Prior to any batches/lot numbers being distributed to testing sites the supplier will provide a minimum of 150 test devices of the final batch to the NICD for assessment.
  • No batch / lot number may be distributed in South Africa without the necessary pre-production and post- production Post Market Surveillance Report from the NICD.
  • A compulsory fee for the assessment of both pre and post- production batches will be applied by the NICD and paid for by the supplier.

19. The supplier will be expected to deliver stock within a specific lead-time to our partner organisation in Musgrave Durban and around Pretoria.

20. A Proposal that address the requirements electronically to applications@isibani.org.za by March, 5th 2020 at 5pm South African time. Late submissions will not be considered.  Please ensure the subject line states “Application – HIV Self Screening Test Kits – ISI2020-HSSTK”.

21. The Proposal Evaluation Criteria

The review of proposal submitted by potential suppliers will be based on the following allocation of evaluation criteria.

EVALUATION CRITERIA

The evaluation process will be conducted in phases as follows:

Phase I Phase II Phase III Phase IV
PPPFA Pre-Qualification Criteria for Preferential Procurement Mandatory and other bid requirements Technical Compliance Price and B-BBEE
In terms of Preferential Procurement Regulation 4(1)(a) only bidders having a stipulated minimum B-BBEE status level contributor from 1 – 8. Compliance with mandatory and other bid requirements
Compliance with WHO requirements
 
Compliance to technical requirements
(sample submission)
Bids evaluated in terms of the 80/20 preference system

PHASE I: PPPFA PRE-QUALIFICATION CRITERIA FOR PREFERENTIAL PROCUREMENT

In terms of Preferential Procurement Regulation 4(1)(a) only bidders having a stipulated minimum B-BBEE status level contributor from 1 – 8.
Bidders are required to complete the preference claim form (SBD 6.1), and submit their original/ originally certified copy B-BBEE status level verification certificate or a sworn affidavit at the closing date and time of the bid in order to prove compliance of the above paragraph.
Failure to meet the requirements as per the above mentioned paragraph(s) may invalidate the bid submitted.
The following documentation must be submitted at the closing date and time of bid. Failure to submit these documents may invalidate the bid. 

No. Document name  Included in the published bid document?
1 SBD 6 (1): Preference Points Claimed (BBBEE) NO
2 Certified BBBEE Certificate or sworn affidavit NO
3 Tax Clearance NO

TAX CLEARANCE COMPLIANCE

It is a condition of this bid that the tax matters of the bidder be in order at any point in time, or that satisfactory arrangements have been made with South African Revenue Service (SARS) to meet the bidder’s tax obligations. The Tax Compliance status requirements are also applicable to foreign bidders / individuals who wish to submit bids.
It is a requirement that bidders grant a written confirmation when submitting this bid that SARS may on an on-going basis during the tenure of the contract disclose the bidder’s tax compliance status and by submitting this bid such confirmation is deemed to have been granted.

PHASE II: MANDATORY REQUIREMENTS:

Bidders must submit all required documents indicated hereunder with the bid documents at the closing date and time of the bid. During this evaluation phase, bidder’s responses will be evaluated based on the documents submitted under mandatory requirements. This phase is not scored and bidders who fail to comply with all the mandatory criteria will be disqualified.

The following documentation must be submitted at the closing date and time of bid. Failure to submit these documents may invalidate the bid. 

No.
Document name 
Included in the published bid document?
1 South African Health Products Regulatory Authority (SAHPRA) license / Acknowledgement letter received from SAHPRA NO
2 Evidence that the test kit appear on the WHO LIST OF PREQUALIFIED IN-VITRO DIAGNOSTIC PRODUCTS as a “HIV RDT for Self-testing” NO

SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA) LICENSE REQUIREMENT FOR MEDICAL DEVICES.

Bidders are required to adhere to Medicines and related substances Act, 1965 (Act No. 101 of 1965), as amended as per the Regulation relating to Medical Devices and In Vitro Diagnostic (IVD’S) Medical Devices. Non-compliance with these conditions will invalidate the bid. Manufacturers, distributors and wholesalers, as referred to in Section 22C(1)(b) of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965), must obtain a licence for the manufacturing, importing, exporting, distribution and wholesaling of medical devices and IVDs, as issued by the South African Regulatory Authority.

Bidders must submit with the bid, on or before the closing date and time of bid, evidence of the approved medical device establishment licence.
In the event that an approved medical device establishment licence and/or registration certificate cannot be obtained from the South African Regulatory Authority, prior to the closing date and time of the bid, the bidder must submit evidence of application made to the South African Regulatory Authority, to be licensed as a medical device establishment (in the form of an Acknowledgement Letter received from the South African Regulatory Authority).

Upon such time that medical devices are called up for registration, via publication in the Government Gazette, bidders, who have been licensed as medical device establishments must submit evidence of the approved registration certificate of the said medical device. Evidence of application made to the South African Regulatory Authority, to register the said medical device (in the form of an Acknowledgement Letter received from the South African Regulatory Authority) will be required during the contract period if applicable.

PHASE III TECHNICAL SPECIFICATIONS

RETURNABLE DOCUMENTS 

The following documentation must be submitted at the closing date and time of bid. Failure to submit these documents may invalidate the bid. 

No. Document name  Included in the published bid document? To be returned by bidder
1 Standards / Specification certificates N Y
2 NICD test report or confirmation letter for submission of samples from NICD N Y

STANDARD / SPECIFICATION

The following pre-award product compliance procedures will apply:

Proof of evaluation information by at least one of the following organisations CDC (USAID list), WHO, FDA, European Union, USFDA, Australian TGA, Health Canada, Japanese PMDA.
Traceability to WHO PQ and /or CE notifying body (CE marking or equivalent)

  • ISO 13485-2016 Certification
  • Test report issued and obtained from NICD

QUALITY

Where specific specifications and/or standards are applicable on materials and supplies, the quality of products shall not be less than the requirements of the latest edition of such specifications and/or standards.

SAMPLES SUBMITTED TO TESTING INSTITUTION

All bidders, including current contractors are required to submit samples at NICD.

Samples for initial assessment must be submitted to the National Institute for Communicable Diseases (NICD) by the closing date and time of bid. The purpose is to obtain a test report for the items being offered in this bid.

Samples must be submitted for sample evaluation to: National Institute for Communicable Diseases (NICD), 1 Moderfontein Road, Sandringham, 2131, for attention: Prof Adrian J. Puren, tel: 011-386 6328, fax: 011 386 6333, email adrianp@nicd.ac.za

Test reports should be issued in the name of the bidder. Should the test report be issued in the name other  than that of the bidder, such test reports must be accompanied by a letter of authority from the manufacturer / authorising importer. 

The bidder must obtain proof from NICD that the sample(s) had been submitted for testing before or on the closing date and time of the bid. Such proof must be submitted with the bid at closing date and time of the bid.

Samples of all products accepted against this bid will be retained for the duration of the contract period.

Bids not supported by test reports at time of evaluation will be disregarded in respect of the item(s) for which test reports are not submitted.

The procedures for sampling and testing for product compliance may differ and should be obtained from the NICD. The cost of compliance testing will be for the account of the prospective bidder. 

The successful bidder must submit a further 150 samples for post marketing surveillance at their cost. Any batch that does not comply with the post marketing surveillance cannot be distributed.

Unsuccessful bidders who have submitted samples must collect such items within 3 months of the commencement of the contract.  Samples not collected within this 3-month period will be disposed of at the discretion of the Isibani Development Partners.

MARKING OF SAMPLES

Samples must be placed in suitable containers and be clearly marked indelibly on the outside with the bid number, item number(s), and the bidder’s name. This detail must appear on a label attached to each individual item package.

All samples, including the labelling requirements, must be a true representation of the product that will be supplied during the contract period.

Where applicable, packaging of samples submitted must be indelibly marked with the expiry date, batch identification prefixed by the “LOT” the word “sterile” and the sterilisation method, Trade name or trademark of the manufacture and product code as relevant.

Failure to comply with this condition may invalidate the bid against the relevant item.

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