Bid Number: ISI2020-SPPE
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 quotations to supply and delivery of personal protective equipment.
2. TERMS OF REFERENCE
2.1. LEGISLATIVE REQUIREMENTS
Products intended to be supplied to support the diagnosis or prevention of the spread of COVID-19, such as masks, gloves, within the definition of a medical device and are regulated by SAHPRA as medical devices under the ambit of the Medicines and Related Substances Act, 1965 (Act 101 of 1965).
All individuals and companies who wish to participate in this tender in their capacity as manufacturers / distributers / wholesalers should have a valid SAHPRA medical device establishment license. Presentation of a SAHPRA acknowledgement letter, acknowledging the submission of an application for a medical device establishment will not suffice in lieu of a valid SAHPRA license.
It is a legal requirement that data submitted for evaluation should substantiate all claims and should meet technical requirements of quality, safety and performance of the product for the purposes for which it is intended. Orders supplied should indicate the quantities supplied against respective batch numbers and the expiry dates. Products that have expiry dates of less than 12 months, will be rejected.
Suppliers should present a clearly defined document and demonstrate the means in which quality complaints of the goods supplied will be handled by the supplier as per SAHPRA regulations under medical devices
2.2. THE BIDDING PROCESS
a. Briefing session
There will be no briefing session for this bid.
b. Subsequent dissemination of information
Interested parties are invited to submit all their enquiries to email@example.com. Responses to all questions will be posted on the following link http://www.isibani.org.za/questionsandanswers.pdf on this 16th October 2020 to promote equal provision of information. Submission of queries closes on 14th October 2020 and no responses will be attended to after 14th October 2020 at 16:00.
2.3 QUALITY CONTROL
The Global Fund has defined the minimum standards of PPE that can be procured with grant funds. Only bidders whose products meet either WHO FDA or EU standards will be considered. Products that do not meet the defined specifications and/ or standards applicable will be rejected and not considered for the bid. Where WHO standards are not listed the products can be procured locally however, these products need to meet the local standards and certification of compliance applies.
All Bids received should be accompanied with a certificate of compliance from an institution accredited by SANAS for quality testing at the time of the bid.
The Certificate of Compliance must be submitted proving that the relevant item(s) comply with the specification after inspection and testing of the samples by the South African National Accreditation System (SANAS) accredited or recognized institution.
In the event that a certificate of compliance cannot be obtained from the testing institution prior to the closing date and time of the bid, the bidder must obtain proof (issued by the testing institution) that the sample was submitted to the testing institution before or on the closing date and time of the bid and provisions of an additional 5 working days will be granted to submit such reports for consideration.
Bids not supported by certificate of compliance at time of evaluation will be disregarded.
Bidders are encouraged to contact the relevant testing institutions in order to timeously obtain information regarding the procedures for sampling and testing for product compliance including the associated costs.
2.4. QUANTITIES TO BE TENDERED FOR
|PRODUCT||PRODUCT DESCRIPTION||GF MINIMUM STANDARDS||QUANTITY|
|Digital Thermometer; Digital Body Thermometer INFRARED NON-CONTACT||Electronic thermometers that assess the temperature by determining the intensity of infrared light emission. These thermometers consist of an infrared probe, electronic circuitry, and a display. These thermometers take a sample of the thermal radiation, usually without contact with the measured object, and display the temperature within a few seconds.||• ISO 80601-2-56:2017
• (EN 12470-5)
• ISO 80601-2-59 Ed. 1.0:2017
• ASTM E1104-98(2016)
• ASTM E1965-98(2016)
• ASTM E1112-00(2018)
• JIS T 4207:2005)
|Face shield||Made of clear plastic and provides good visibility to both the wearer and the patient, Adjustable band to attach firmly around the head and fit snuggly against the forehead, Fog resistant (preferable), Completely cover the sides and length of the face, May be re-usable (made of robust material which can be cleaned and disinfected) or disposable.||• EU PPE Regulation 2016/425, CE Notifiying Body must be declared
• EN 166,
• ANSI/ISEA Z87.1,
|Gown, surgical||Single use, disposable, length mid-calf.||• EU PPE Regulation 2016/425 Category III,
CE Notifiying Body must be declared
• EU MDD (directive) 93/42/EEC Class I
• FDA class 2,
• EN 13795 any performance level, or
• AAMI PB70 all levels acceptable,
• ASTM F2407
|Particulate respirator, grade N95/FFP2 or higher||N95 or FFP2 respirator, or higher
Good breathability with design that does not collapse against the mouth (e.g. duckbill, cup-shaped)
|• EU PPE Regulation 2016/425 Category III, CE Notifiying Body must be declared
• EU MDD (directive) 93/42/EEC Class I,
• FDA Class 2
• Minimum "N95" respirator according to, under NIOSH 42 CFR 84,
• Minimum "FFP2" according to EN 149
|Alcohol-based hand rub -Sanitiser||Bottle of 100ml & 500ml, at least 80% ethanol or 75% isopropyl alcohol (v/v)||• ASTM E2755, or
• EN 1500
• ASTM E1115, or
• ASTM E1174
|100ml - 600
500ml - 621
|Handwash 500mls||Bottle of 100ml & 500ml||• EN 1499
• ASTM E1174
|100ml - 50
500ml - 150
|Hand drying tissue (500 mm roll)||50m to 100m roll||100mm or 500mm roll||200|
|Safety Box||SAFETY BOX, needles/syringes, 5l, cardboard for incineration, box-25||Biohazard Label as per WHO PQS E010/011||10|
|Gloves, examination, nitrile, powder-free, non-sterile. (e.g. minimum 230mm total length. Sizes, minimum thickness 0.05mm,||• EU MDD (directive) 93/42/EEC Class I,
• EU PPE Regulation 2016/425 Category III, CE Notifiying Body must be declared
• FDA Class 1
• EN 455,
• EN 374,
• ASTM D6319,
Small: 15 000
Medium: 36 000
|Mask, medical Patient||Medical mask, good breathability, internal and external faces should be clearly identified||• EN 14683 any type including Type I
• ASTM F2100 any Level
|Mask, medical Healthcare worker||Medical mask, good breathability, internal and external faces should be clearly identified||• EU MDD (directive) 93/42/EEC Class I,
• EU PPE Regulation 2016/425 Category III, CE Notifiying Body must be declared
• FDA Class 2
• EN 14683 Type II, IIR
• ASTM F2100 minimum Level 1
2.5. MANDATORY ADMINISTRATIVE REQUIREMENTS
It is the responsibility of each supplier to ensure that complete documents are submitted on or before the closing date and time.
The bidders must submit all required documents indicated hereunder:
- Declaration of Interest SBD4. https://etenders.treasury.gov.za/content/tender-documents
- Declaration of Bidder’s past Supply Chain Management Practices SDB8. https://etenders.treasury.gov.za/content/tender-documents
- B-BBEE Status Level Verification Certificate (where preference points are claimed) (Original or Certified Copy).
- Certified copy of registration certificate with CIPC or proof of ownership/ shareholding.
- Valid SAHPRA medical device establishment license to distribute wholesale or manufacture PPE
- Certificate of compliance that demonstrates all PPE products bided for meet the WHO/FDA/EU standards.
- Results of the test from a SANAS accredited institution or Proof of submission for testing.
- The supplier must submit the Tax Clearance Certificate for confirmation of Value Added Tax (VAT) and other Tax related matters.
- All submissions must include a certification by the Chief Executive Officer of the bidding supplier that all quoted materials meet the technical specifications required under this TOR and the company warranties against defects.
- The supplier must submit a profile of the entity which includes but is not limited to the following:
Name, structure and strategies,
Names and identity numbers of all directors, chief operating officers,
Business: products and/or services which the entity is trading.
- Risk management strategy to mitigate against any risk that might arise for the duration of the contract.
- Three (3) testimonials/ references (which should be linked to the PPE item that the bidder is bidding for) from previous contractors/client clearly demonstrating contract value and quantities.
- Stamped Bank Confirmation Letter.
- All bid documents must be submitted on or before the closing time of the bid (date and hour specified in the bidding documents). Late submissions will not be considered
- Incomplete bids will be deemed non-responsive.
2.6. SPECIAL CONDITIONS
- The bidder must ensure the correctness and validity of the quote. All price(s) and quantities quoted are at the bidder’s risk. The prices quoted shall be “firm prices” and shall remain valid for the procurement period. Non-firm prices (including rates of foreign exchange variations) will not be accepted.
- The sub recipients reserve the right to conduct supplier due diligence prior to final award or at any time during the contract period. This may include site visits.
- The sub recipients reserve the right to award according to the most economical service option submitted. And will under no obligation accept the lowest or any quote.
- The sub recipients reserve the right to stop the contract partly or, temporarily or indefinitely, in which event neither claim nor liability whatsoever shall lie against the contractor either due to non-compliance, non-performance, by the supplier.
- The sub recipients reserve the right to not make an award.
- The sub recipients reserve the right to conduct price negotiations, where deemed necessary.
- The sub recipients reserve the right to request any relevant documentation at any stage of implementation.
- All suppliers are bound to protect the confidentiality of all data (including the protection of personal information) and information gathered and accessed through the work on assignment. Information and data received and accessed through this project may only be used to meet the objectives outlined in these specifications.
3. BID EVALUATION CRITERIA
Bids will be evaluated in a two (2) phase stage
Phase 1: Bidders must satisfy the mandatory administration criteria for them to be evaluated further. Bidders who do not meet the criteria will be disqualified and will not be eligible for further evaluation.
Phase 2: Bid Scoring
|1||Company profile including the history of operation.||10%|
|2||Sense of Reliability and Continuity of Supply||15%|
|3||Relevant Experience of Personnel||10%|
|4||Previous Experience with Similar Project||15%|
4. CLOSING DATE
All bid documents that address the requirements must be emailed to firstname.lastname@example.org by 22nd October 2020 at 4pm South African time. Late submissions will not be considered. Please ensure the subject line states “Application - Supply PPE Bid Number: ISI2020-SPPE”