Invitation for Prequalification of suppliers of laboratory equipment (including installation, training and maintenance), reagents, chemicals and consumables for diagnosing TB and ensuring biosafety

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https://esourcing.unops.org/#/Help/Guides	UNOPS eSourcing – Vendor guide and other system resources / Guide pour fournisseurs et autres ressources sur le système / Guía para proveedores y otros recursos sobre el sistema

New clarification added: Lot 1 / Item 348 - Conductivity meter - included with AutoclavesCould you please specify if the instrument is handheld or benchtop?Or should it be somehow in-built in the Reverse Osmosis Water purification system (Lot 2 / Item 489)?Answer:The technical specifications for the item number 348 106125 Conductivity meter: did not specify the size. Therefore, if desire, please add the size in the Annex 7 Lot 2 Detailed Technical Specifications Bid Form under this item number.The Reverse Osmosis Water purification system is a separate item. Please see below the item with the accessories: 489 Reverse osmosis water purification system 490 Sediment pre-filters 491 Activated carbon filters 492 Ion cartridges 493 Reverse Osmosis membrane 494 Post-filtration module

Edited on: 14-Jun-2019 14:11

Edited by: webservice@unops.org

New clarification added: 64. In the 'Document Checklist' section, at point 26 you request us to submit the full data sheets for all reagents, DSTs, and chemicals. Then at point 27, you ask us to attached the MSDS sheets for all products where available. Please note that for reagents, DST,s and chemicals, there is no regular 'data sheet', this is automatically an MSDS sheet. Furthermore, for all other items there is in most cases not an MSDS available unless the equipment includes batteries. Please therefore confirm how to treat points 26 and 27 of the checklist section.Answer:Please refer to the Section II Schedule of requirements 3.6. Documents to be submitted with the Bids: b. For all reagents, drug susceptibility tests (DSTs) pure drugs and chemicals: Applicants must provide the full data sheet of products offered (in PDF format). The data sheet can be the specifications sheet.Please refer to the Section II Schedule of requirements 3.6. Documents to be submitted with the Bids: c. For all products (where applicable): Applicants must provide a copy of the Material Safety Data Sheets (MSDS) of products offered (in PDF format)

Edited on: 13-Jun-2019 19:11

Edited by: webservice@unops.org

New clarification added: 63. For item 316, GDF code 106441 (hair covers): 1. The requirement 'Impermeable to liquids' doesnt match with the required material (PP) and product, normally hairnets should be breathable and therefore not impermeable to liquids.2. Furthermore, the requirements mention both 'made of non-woven polypropylene, while on the next line it states polyethylene weight of at least 42 gm/m2. Please confirm which material is required, and please note that just as indicated earlier under question 62 for item 315, the requirement of 42gm/m2 is taken from a different product (coveralls), for this kind of item (hair cover) the normal thickess is approx. 12-13 grammes. Answer:The technical specifications requested for the item number 316, 106441 Laboratory hair covers: is Impermeable to liquids.The technical specifications for the item number 316, 106441 Laboratory hair covers: did not specify the thickness. Therefore, if desire, please add the thickness in the Annex 5 Lot 1 Detailed Technical Specifications Bid Form under this item number.The technical specifications requested for the item number 316, 106441 Laboratory hair covers: is made of non-woven polypropylene;Please apology for the typo: The technical specifications for the item number 316, 106441 Laboratory hair covers: is polypropylene weight of at least 10grams/m2.

Edited on: 13-Jun-2019 19:06

Edited by: webservice@unops.org

New clarification added: 62. For laboratory shoe covers (item 315, GDF code 106440), we have the following questions: it is requested to have 'Polyethylene weight of at least 42gm/m2;', but this requirement is copied from coveralls. Normally, for this item it is indicated in thickness (in mm), also for the current contract an item with 0.03 mm (+/- 5%) is included. Therefore, for this item please confirm that the required thickness is 0.03 mm(+/- 5%) for this item since 42gm/m2 doesn't apply. Answer:The technical specifications for the item number 315, 106440 Laboratory shoe covers: did not specify the thickness. Therefore, if desire, please add the thickness in the Annex 5 Lot 1 Detailed Technical Specifications Bid Form under this item number.The technical specifications requested for the item number 315, 106440 Laboratory shoe covers: is Polyethylene weight of at least 42grams/m2.

Edited on: 13-Jun-2019 19:01

Edited by: webservice@unops.org

New clarification added: LOT 2 / Item 511 - NEW ITEM Biosafety Cabinet II-B1 2 filters 5 feetCould you please check the requirements, as none of the manufacturer can offer BSC of type B1 with 2 filters and 5 feet long?The manufacturers have B1 with 2 filters either 4 feet or 6 feet.Answer:The requirement for the new item number 511 in Lot 2 item for the Biosafety Cabinet II-B1 2 filters is 5 feet.Please remember that Applicants are not required to provide an offer for each item (“applicant can offer at least ONE product for Lot 2”), even if strongly recommended.

Edited on: 13-Jun-2019 18:52

Edited by: webservice@unops.org

New clarification added: We are very grateful that the deadline was extended with one week from 14-6 until 21-6. As mentioned in our request for deadline extension, a two-week extension would allow us to submit a complete bid for both LOTs, including all required documentation and information. We understand that you want to receive the bids as soon as possible to initiate the evaluation process, however the number of items involved in combination with the very extensive required documentation that needs to be submitted for all 530 items, we would appreciate more time, especially for the gathering and saving of all those documents. We have actually put a dedicated team on this but face challenges gathering all documentation from the manufacturers in a timely matter, also because some suppliers are involved in this project with a lot of items and can only send the required documentation in tranches. In that light, would you please be so kind to let us know if deadline extension until 28-6 would be feasible? Answer: Please note that the Pre-qualification tender has been launched on the 24 April 2019 with an initial submission deadline by 31 May 2019. It has been extended to 14 June 2019 and a second extension has been granted until 21 June 2019. No further extension is possible for this prequalification process.

Edited on: 13-Jun-2019 14:12

Edited by: webservice@unops.org

New clarification added: 61. In Annex 3 at paragraph 7 (Personal Protective Equipment), there are two ISO norms mentioned for PPE items: ISO 13688 for protective clothing, and ISO 16900-7 for respiratory devices. Since 'protective clothing' is different than 'respiratory devices', we kindly ask you to add a column to the earlier additional bid document you added (named 'List of personal protective items in Lot 1 and Lot 2), in which column you indicate which of the two norms applies for that item. This because for example for a mask, only the ISO 16900 would apply since it is a respiratory device and doesn't qualify as clothing, let alone protective clothing.Answer: In section 7 of Annex 3: Personal protective equipment, it is states: ‘ii. ISO 16900-7:2015 - Respiratory protective devices -- Methods of test and test equipment -- Part 7: Practical performance test method’. Masks being respiratory devices fall under this ISO standard.

Edited on: 13-Jun-2019 14:05

Edited by: webservice@unops.org

New clarification added: We are kindly asking you to postpond the submittion of this tender for extra 2 weeks, as number of items is very big, also ther is a lot of docments requested, so please give us more time in order to submitt a complete, & satisfying offer.Answer: Please note that the Pre-qualification tender has been launched on the 24 April 2019 with an initial submission deadline by 31 May 2019. It has been extended to 14 June 2019 and a second extension has been granted until 21 June 2019. No further extension is possible for this prequalification process.

Edited on: 13-Jun-2019 14:00

Edited by: webservice@unops.org

New clarification added: Regarding the item number 106241 (Measuring pipette for BSC 1 ml), the specifications of Annex 5 are not indicating the material but they seem to point towards a plastic product (individually wrapped); however the product previously purchased was a glass pipette.Can you specify the material of this item?Answer: The material of the item number 106241 (Measuring pipette for BSC 1 ml) is clear glass.

Edited on: 12-Jun-2019 11:08

Edited by: webservice@unops.org

New clarification added: Lot 1 / Item 348 Could you please specify if the instrument is handheld or benchtop?Or should it be somehow in-built in the Reverse Osmosis Water purification system (Lot 2 / Item 489)?Answer:Are you referring to the autoclaves? There is not handheld option for autoclaves. Please see the 4 autoclaves requested in Lot 1 and Lot 2o Lot 1341 106116 Benchtop autoclave 80 lto Lot 2:464 NEW ITEM 15.1 Benchtop autoclave 40 lt473 NEW ITEM 15.10 Vertical autoclave 40 lt481 NEW ITEM 15.18 Vertical autoclave 80 lt· The Reverse Osmosis Water purification system is a separate item and it is not inbuilt in the autoclave

Edited on: 11-Jun-2019 17:46

Edited by: webservice@unops.org

New clarification added: Is there any specific date format to be followed or mm/dd/yyyy works? Document Submission: Mandatory - 13. For JVs, copy of the business license of all parties constituting the consortium - In our case, there is no Joint Venture. Should we upload a blank document to proceed to submission? Also, Form F: Annual turnover Form - Generally, company turnover is the amount or sum of money that a business has collected from its normal business practices, amount from the sale of goods and services. Let us know if it has a different meaning here.Answer:No, there is no specific date format to be followed. mm/dd/yyyy is fineFor Form A: Joint Venture Partner Information Form: if there is no Joint Venture then please mentions (Not Applicable/NA) and upload it and proceed to submissionForm F: Annual Turnover Form: Annual Turnover refers to the total sales (amounts billed to clients) of the applicant/bidder per year.

Edited on: 11-Jun-2019 17:40

Edited by: webservice@unops.org

New clarification added: 60. For items with GDF code 106551 up to 106553 (disposable laboratory coats), a sterile product is requested. However, this means that you are actually looking for a surgical gown, which is a disposable coat that can indeed be delivered sterile. Furthermore, the current disposable laboratory coats included in this same LTA are also non-sterile, so if sterile is now a requirement the product that should be requested is a surgical gown. Please clarify from your side, in order for us to proceed accordingly.Answer: For the item numbers 106551 up to 106553: Disposable laboratory coats (S, M and L): please be noted that there was a typo in the Annex 5 Lot 1 Detailed Technical Specifications Bid Form: we want non-sterile laboratory coats.

Edited on: 11-Jun-2019 17:35

Edited by: webservice@unops.org

New clarification added: Can you shed more light on what 'Annual Turnover data' means on Form F: Annual Turnover form please? Answer: Form F - Annual Turnover Form: Annual Turnover refers to the total sales (amounts billed to clients) of the applicant/bidder per year.

Edited on: 11-Jun-2019 17:31

Edited by: webservice@unops.org

New clarification added: 59. There is a discrepancy in the item numbers 121 - 125 and corresponding GDF Product Name between Annex 4 and Annex 5 of the tender documents, please find the overview in table below: No. GDF Code Sub-Lot GDF Product Name – Annex 4 GDF Product Name – Annex 5121 106237 Consumables PP test tube rack for 16 mm tubes Stainless steel test tube rack for 18 mm tubes122 106238 Consumables PP test tube rack for 18 mm tubes Stainless steel test tube rack for 35 mm tubes123 106239 Consumables PP test tube rack for 30 mm tubes PP test tube rack for 16 mm tubes124 106230 Consumables Stainless steel test tube rack for 18 mm tubes PP test tube rack for 18 mm tubes125 106231 Consumables Stainless steel test tube rack for 35 mm tubes PP test tube rack for 30 mm tubes Kindly confirm which item number and GDF Product Name order is correct, Annex 4 or Annex 5 of the tender documents?Answer: Noted and apologies. Please add the information as it is. The products will be evaluated with the swapped order number (121-125) in Annex 5: Lot 1 Detailed Specifications Bid Form.This was clarified earleir as well.

Edited on: 06-Jun-2019 16:05

Edited by: webservice@unops.org

New clarification added: 58. For the UV crosslinker (GDF reference 106411), can you please check and reconfirm the requested energy dose range in mJ/cm2? This turns out to be differring factor x 10 from what is available within the market.Answer:The Energy dose range for the item number 27 106411 UV crosslinker is of at least from 0,200 μJ /cm2 to 999,9 μJ /cm2

Edited on: 06-Jun-2019 15:29

Edited by: webservice@unops.org

New clarification added: We are fully engaged in this tender from the beginning and are dedicated to submitting a complete bid for both LOTS covering all items with all accompanying documentation and completed Annexes with all requested information. In order to do so, it would be very helpful if more time could be granted, since numerous manufacturers are involved that all need to gather and submit the required documentation and information. We would herewith like to request a deadline extension of this tender, in order for us to be able to submit a complete bid with all requested documentation and information (ISO/CE/MSDS/brochures/MAFs/product details/inserts/Forms A till K/etc). Lastly, to ensure compliancy, all manufacturer proposals are checked individually to establish compliancy, which takes a lot of time but is needed to meet the compliancy threshold as stated. It would very much help if a 2-week extension (till 28-6-2019) could be granted. Answer: The submission deadline has been extended to 21 June 2019 (10:00 UTC).

Edited on: 06-Jun-2019 15:15

Edited by: webservice@unops.org

New clarification added: 57. With regards to the additional services requested (training/installation, maintenance): in the requested conditions for these services as listed in the Annexes 5 and 7 (Detailed Technical Specifications Bid Form), several time reference is made to indicate what is and what isn't included in the price (for example, see GDF item 106116 - G. Maintenance - 1 year (NEW ITEM), and GDF item 106490 - ACCESSORIES INCLUDED WITH AUTOCLAVE - F. Installation and training). However, as per earlier clarifications from your side it was clearly stated that this isn't a ITB yet, so please explain why for services we have to provide information as to what is and what isn't included in the price? This normally forms part of the ITB process, and if this is needed in this stage already it means a lot of extra work for all manufacturers of items where additional services are needed.Answer: The applicants are requested to describe what is included in the services offered for the autoclaves and the biosafety cabinets (installation, training, maintenance).The applicants are not required to provide any financial offer in the pre-qualifications process. If pre-qualified, the specific item number with the offered description will be requested for a price in the ITB.

Edited on: 06-Jun-2019 15:08

Edited by: webservice@unops.org

New clarification added: 56. We kindly thank you for the very clear feedback regarding ISO 9001/13485, this is all clear now. However, the clarifications/amendment as posted (b. Amendment of Conformity of Products with Standards), which relates to EC Declaration of Conformity, is still unclear because at question 20, we asked you to explain why at all items, recognition by a GHTF founding member was requested since basically, this means that all items need to have a CE certificate or EC DoC. However, as stated earlier, not all products in this tender are subject to CE marking, for example reagents and certain non-medically related items. The two guidelines which you now refer to (GHTF/SG1/N78:2012: Principles of Conformity Assessment for Medical Devices and GHTF/SG1/N046:2008: Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Device) only cover either Medical Devices or IVD's, and as mentioned before there are a lot of items in this tender which do not qualify as either a Medical Device or IVD. To clarify this once and for all, it would be highly appreciated if you can confirm the following: for Sub-Lots 'Autoclaves', 'Biosafety Cabinets', and 'Equipment', a CE certificate and/or EC DoC needs to be submitted. For Sub-Lots 'Reagents' and 'Consumables', a CE certificate or EC DoC should only be provided if available/applicable.Answer: We refer you to the latter part of the amendment ‘Amendment of Conformity of Products with Standards’ that states ‘Any product in Annex 1 for which Annex 3 Section 4 does not apply, such as shelves, laboratory chairs etc., the applicant should provide an equivalent where applicable’.

Edited on: 06-Jun-2019 15:03

Edited by: webservice@unops.org

New clarification added: 55. With regards to the requirement to receive the 'primary and secondary packaging with readable label information minimum in English' as stated at point 27 of the Document Checklist section: you earlier provided feedback on our earlier question 13 stating that the primary and secondary packaging is needed for customs clearance by the GDF clients. However, based on this feedback and on the fact that a lot of manufacturers aren't able or willing to provide this documentation in this compliancy stage (they will only submit it as soon as they are allowed to submit their actual price quotation as part of the ITB to follow later), please confirm that providing the primary and secondary packing should only be done where available because if this documentation is needed for customs clearance, it would be more suitable to receive this documentation at time of the ITB to be launched later. Lastly, since packing layout changes frequently, it would also be more reliable to do this together with the ITB to receive the most up-to-date packing layouts. Answer: Please follow the section II schedule of requirements 3.6.d. Applicants must submit product photo combined with other technical information and the primary and secondary packaging with readable label information minimum in English (in JPEG format) for all products offered.

Edited on: 06-Jun-2019 14:56

Edited by: webservice@unops.org

New clarification added: Dear Sir/Madam,Hope this request finds you well.We are working on the prequalification and we trust that we can submit a good prequalification proposal.However, unfortunately there are a lot of clarifications and also late clarifications. To make sure that we can add or adjust information properly, we would like to ask for an extension of the deadline. We are confident that with a longer lead-time we can guarantee to submit a suitable and complete prequalification dossier. Answer: The submission deadline has been extended to 21 June 2019 (10:00 UTC).

Edited on: 06-Jun-2019 14:49

Edited by: webservice@unops.org

New clarification added: Dear Procurement-Team,Due to the complexity of number of items involved and documentation from various parties required, we would kindly ask you for another week of extension of this solicitation to enable all participants involved to submit a fully compliant and complete proposal against this bidding exercise.We thank you very much for your understanding and look forward to your response.Answer: The submission deadline has been extended to 21 June 2019 (10:00 UTC).

Edited on: 06-Jun-2019 14:43

Edited by: webservice@unops.org

New clarification added: Considering the complexity of the project and the number of the required items and requested information and documentation, we would kindly ask you for a deadline extension for at least 2 additional weeks. Answer: This tender was launched on the 24 April 2019 with an initial submission deadline by 31 May 2019. It has been extended once to 14 June 2019.The submission deadline has been extended to 21 June 2019 (10:00 UTC).

Edited on: 06-Jun-2019 14:35

Edited by: webservice@unops.org

New amendment added #5: 1. To extend the Submission Deadline to 21 June 2019 (10:00 UTC). 2. To extend the Deadline for Clarifications to 12 June 2019 (12:00 UTC).

Edited on: 05-Jun-2019 09:54

Edited by: webservice@unops.org

New clarification added: 54. For all pipettes, an automatic tip-eject feature is requested while for most European brands, this is still done manually to improve battery life and therefore sustainability. Please let us know if manual tip ejection is workable, especially if the pipette meets all requirements as stated.Answer: Please see that the requested specification “Provided with automatic tip-eject feature”, means a system/feature that removes pipette-tips with no direct physical contact by the operators hands, and so is met by a manual operated tip-ejection system/feature.

Edited on: 04-Jun-2019 19:11

Edited by: webservice@unops.org

New clarification added: 53. For item with GDF reference 106048 (microcentrifuge), please confirm that a rotor made of PP material is also acceptable since this is a more common material used nowadays instead of aluminium, while the centrifuge still meets all IEC norms and performance levels as needed.Answer: The technical specifications requested for item number 29 106048 Microcentrifuge is: Fixed-angle rotor made of carbon or aluminum.

Edited on: 04-Jun-2019 19:08

Edited by: webservice@unops.org

New clarification added: 52. For the item with GDF reference 106394 (pasteur pipette 3ml), please confirm that the requested length of 150 mm is an indication while 140mm is more common, still being a 3ml pipette. Answer: The length requested for the item number 155 106394 Sterile Pasteur pipettes 3 ml is of 150 mm.

Edited on: 04-Jun-2019 19:04

Edited by: webservice@unops.org

New clarification added: 51. For sterile products, for example for item with GDF reference 106236 (Sterile inoculation loop), it is requested to have individually wrapped packing. However, from a sustainability perspective it is more and more common practice to pack these items in (zip-lock) packs of several pieces to save down on packing material, while sterility is still maintained and performed as needed. Please confirm how to proceed with this to ensure our bid includes most sustainable options.Answer: The technical specifications requested for the item number 141 106236 Sterile inoculation loops 10 µl is: Individually wrapped.

Edited on: 04-Jun-2019 19:00

Edited by: webservice@unops.org

New clarification added: 50. For item with GDF code 106230 (Stainless steel tube rack), please confirm if it is OK to quote a product with deviating number of places in the rack, since simply more or less racks can be ordered to meet the required total number of places. Answer: The technical specifications requested for the item number 121 106230 Stainless steel test tube rack for 18 mm tubes: is of 3 x 12 places: total of 36 places.

Edited on: 04-Jun-2019 18:56

Edited by: webservice@unops.org

New clarification added: 49. For item 346 (Cleaner and disinfectant for instruments), please explain why the following is requested: 'Suitable to be also used as pre-cleaning solution;' Since the requested specs clearly mention a cleaning solution, what is meant with 'pre-cleaning'? Answer: The item 346 is: 106580 Autoclaves: Medical air compressor for benchtop autoclave 80 lt. Can you please confirm the item number?If refer to item number 331 106294 Cleaner and disinfectant for instruments: “Suitable to be also used as pre-cleaning solution”. This means to remove any contamination and coarse contaminants from the used instruments.

Edited on: 04-Jun-2019 18:51

Edited by: webservice@unops.org

New clarification added: 48. For item 48 till 51 (refrigerators & freezers), please confirm if the requirement to have an automatic defrost system is mandatory since even for high-end European options, from a sustainability perspective (less power consumption) natural defrosting is more common. Same applies for internal LED lighting.Answer: The technical specifications requested for items 48 to 51 is with: Automatic defrost system.

Edited on: 04-Jun-2019 18:46

Edited by: webservice@unops.org

New clarification added: 47. For all items where a voltage range is applicable: please note that most manufacturers produce equipment that can work both with low voltage (100-120V) and high voltage (220-240V), but in some cases the manufacturers have different product reference codes for the same item with a different voltage range. Since voltage is also different per destination, please confirm that this is acceptable since at time of PO, the right voltage can be selected. Answer: For all items where a voltage range is applicable that can work with both low and high voltage, it is correct at the PO stage, the right voltage can be selected. Absolutely nothing else can be changed (that includes the price).

Edited on: 04-Jun-2019 18:42

Edited by: webservice@unops.org

New clarification added: 46. For item 418 (ELISA microplate shaker), pleqease confirm of an orbit diameter of approx. 2 mm is also acceptable instead of the requested 2.5mm. Answer: The orbit diameter requested for the item 418 NEW ITEM ELISA Microplate shaker is of at least 2,5 mm.

Edited on: 04-Jun-2019 18:38

Edited by: webservice@unops.org

New clarification added: 45. For item 57 (Hot plate stirrer), please confirm if a temperature range of +30 till +330 degrees Celsius also suffices instead of the requested range (50-360 degrees Celsius), since the range from +30 till +330 is more commonly used and manufactured. Answer: The temperature range requested for item 57 106132 Hot plate stirrer is: of at least 50-360°C

Edited on: 04-Jun-2019 18:35

Edited by: webservice@unops.org

New clarification added: 44. For equipment where over-temperature protection is required, please indicate if this is mandatory since not all manufacturers can adhere to this while they still meet the required specifications as stated. Answer: Please follow the requested technical specifications indicated per each equipment given for Lot 1 in Annex 5 Lot 1 Detailed Technical Specifications Bid Form and for Lot 2 in Annex 7 Lot 2 Detailed Technical Specifications Bid Form.

Edited on: 04-Jun-2019 18:30

Edited by: webservice@unops.org

New clarification added: 43. For items 302 till 304 (Lab coats), a cotton weight of 205 g/m2 is requested while 180 gsm is more common, again from a sustainability perspective to reduce cotton consumption and still maintain the purpose of the product (chlorine resistant, washable, 100% cotton, etc.). Please confirm that the now more common norm is acceptable to meet sustainability developments going on within the market. Answer: The technical specifications requested for the cotton laboratory coats, items 302 to 304 is: Cotton weight of at least 205 g/m².

Edited on: 04-Jun-2019 18:26

Edited by: webservice@unops.org

New clarification added: 42. For item 24 (Thermocycler), it is requested for this piece of equipment to have the auto-switching function between 50/60 Hz. However, the most commonly used German brands prefer to still work with manual switches from a safety perspective, again in relation to unreliable power supply/voltage locally. Please confirm if this is workable if the products meets all requirements as stated in the Technical Specifications. Answer: The power supply requested for the item number 24 106046 Thermocycler is: input voltage range is at least of 100 to 240 V 50/60 Hz autoswitching.

Edited on: 04-Jun-2019 18:22

Edited by: webservice@unops.org

New clarification added: 41. With regards to item 15 (Dispenser pipette 10 ml), a charging adapter and rechargeable battery are requested. However, it is more common in the market to supply pipettes with a button cell battery (3V) with at least 2 years of operational shelf life since in some locations, there isn't always (reliable) power supply available. Please confirm if the more common battery solution is accepted. Answer:The accessories requested for the item number 15: 106115 Dispenser pipette 10 ml, included:Charging adapter/ Universal power supply device input voltage range at least 100 to 240 V 50/60 Hz autoswitching.One (1) Lithium-ion rechargeable battery.

Edited on: 04-Jun-2019 18:18

Edited by: webservice@unops.org

New clarification added: 40. For the glass flasks (items 242 till 244), a wall thickness of at least 2.5 mm is requested, but because of ongoing efforts to reduce on glass consumption from a sustainability perspective, there are products in the market that do meet the requested ISO 4796 norms and are made a borosilicate 3.3 glass, but have a thinner wall. Please confirm if this is acceptable, since these products are fully compliant on all levels of requirements.Answer: The wall thickness requested for the glass flasks, items 245 to 249, is of at least 2.5 mm, preferably 3 mm;

Edited on: 04-Jun-2019 18:14

Edited by: webservice@unops.org

New clarification added: 39. For all glassware items where a 'double scale' is requested (such as the Glass beakers, items 245 till 249): please note that a double scale for lab glassware is not common and therefore becoming less and less available in the market, since the scale that is indicated on the product is so clearly indicated on the product that it can be seen through the glass and therefore the double scale becomes obsolete. Kindly confirm that a single scale marking also suffices, moreover since the products with single scale do meet the comparable relevant DIN/ISO norms.Answer: The technical specifications requested for glass beakers, items 245 to 249, is double Scale, graduated.

Edited on: 04-Jun-2019 17:55

Edited by: webservice@unops.org

New clarification added: 38. For item 8 (Tripod stand), stainless steel material is requested but for this item, galvanised iron is more common applied. Please confirm that galvanised iron is also accepted since the product meets the same purpose and requirements (such as being corrosion resistant, asbestos free, etc.)Answer: The material requested for the Tripod stand is made of stainless steel or better material

Edited on: 04-Jun-2019 17:50

Edited by: webservice@unops.org

New clarification added: 37. With reference to your earlier provided feedback on our question 34 (regarding the gloves, RFQ items 293 till 301): you state that the thickness of 0.3 and 0.35mm is based on single measurement, but according to manufacturers it is impossible to supply gloves with a single thickness of 0.3 mm (so 0.6 double thickness) since these would not be gloves for daily laboratory use but instead it would be household gloves, that moreover could never be packing in dispensers of 100. Also looking at the current gloves supplied under the contract, we see that the thickness is 0.30 mm double measured at the finger and 0.22 mm double measured at the palm. The now requested specs are not in line with what both the market is able to offer and what is currently supplied under this contract.Answer:For Latex gloves, items 293 to 295, the requested thickness is of at least 0,3 mm.For disposable nitrile gloves, items 296 to 298, the requested thickness is of at least 0,3 mm.For non-disposable nitrile gloves, items 299 to 301, the thickness is of at least 0,35 mm.

Edited on: 04-Jun-2019 17:44

Edited by: webservice@unops.org

New clarification added: For companies that are not bidding as part of a Joint venture, is the FORM A still mandatory?Answer: Form A is only required when a submission is made as part of consortium, association and or joint-venture. In case no joint-venture formed, the form should still be submitted indicating ‘Not Applicable’ remark.

Edited on: 04-Jun-2019 17:37

Edited by: webservice@unops.org

New clarification added: 36. For all the BioSafety Cabinets stands (for instance item 355) the requested specification is: “Adjustable height range: 850 mm up to 850 mm”. We assume since you require an adjustable height range that this is wrong. If correctly assumed, please provide the correct minimum and maximum heights.Answer: Apologies for the typo, it should read: Adjustable height range: 850 mm +/- 50 mm

Edited on: 04-Jun-2019 17:32

Edited by: webservice@unops.org

New clarification added: 33. We apologize for having to come back again on question 15 and 28, but we need to get your confirmation that if we propose a product with ISO 9001 (since this is applicable for that specific product) instead of ISO 13485 as requested in column V of Annex 1 (Products List), this will be accepted and will not lead to non-compliancy. Your current reply to our question 28 doesn’t give us full certainty, since it just states to include ISO 9001 and/or ISO 13485.Answer: Please refer “rev 4” under Amendments section posted on 04 June 2019

Edited on: 04-Jun-2019 14:43

Edited by: webservice@unops.org

New clarification added: 30. In Annex 3 (Technical Requirements for Medical Devices), at paragraph 4 the following is stated:“A diagnostic product declaration of conformity should be in accordance with GHTF/SG1/N78:2012: Principles of Conformity Assessment for Medical Devices with the relevant documentation. Proof of conformity to product specific standards should be provided for the product category covering the products to be supplied.”However, as mentioned before, a lot of products in this tender do not qualify as a diagnostic product, as they can be used in a lot of (lab) settings and not just as a diagnostic product. Furthermore, items like baskets, plastics, etc. are totally not diagnostic. So it is a bit hard to understand for which items a Declaration of Conformity is mandatory. If this is mandatory for all products, this will be a lot of work and not possible for all items because of above explanation.Furthermore, as indicated before and confirmed from your side, the GHTF doesn't exist anymore and therefore the requireed norm for DoC's should not apply. Please confirm. Answer: Please refer “rev 4” under Amendments section posted on 04 June 2019

Edited on: 04-Jun-2019 14:37

Edited by: webservice@unops.org

New amendment added #4: a. Amendment to clarify UNOPS/StopTB-GDF quality assurance requirements In the Section II Schedule of Requirements section (4.3, a, i), it states that: “Manufacturers of products shall be certified according to ISO 13845 or equivalent quality management system.” For more clarity, this section is amended to read: Manufacturers of products shall be certified according to ISO 9001 or ISO 13845 or equivalent quality management system for the products offered. The applicant should provide a copy of the manufacturer’s ISO 9001 or ISO 13485 certificate or equivalent that applies for the products offered. This clarification also applies to the following sections of the specified documents· Column T of the document Annex 1: UNOPS Stop TB-GDF products list, Lot 1 & 2Column L of the document Annex 4 and 6 Products Technical Bid Form where the applicant is asked to confirm if the manufacturer of the product is: ISO 13485 certification or equivalent for manufacturer? (Yes/No), please specify which.b. Amendment of Conformity of Products with StandardsAnnex 3, UNOPS Stop TB-GDF General Technical Requirements for Medical Devices, Section 4: Conformity of products with standards states:A diagnostic product declaration of conformity should be in accordance with GHTF/SG1/N78:2012: Principles of Conformity Assessment for Medical Devices with the relevant documentation. Proof of conformity to product specific standards should be provided for the product category covering the products to be supplied.For more clarity, this section is amended to read:A product declaration of conformity should be in accordance with GHTF/SG1/N78:2012: Principles of Conformity Assessment for Medical Devices and GHTF/SG1/N046:2008: Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Device. Proof of conformity to product specific standards should be provided for the product category covering the products to be supplied where applicable.Consequently, GHTF/SG1/N046:2008: Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Device is added as an applicable guideline in Annex 3.Any product in Annex 1 for which Annex 3 Section 4 does not apply, such as shelves, laboratory chairs etc., the applicant should provide an equivalent where applicable.

Edited on: 04-Jun-2019 14:25

Edited by: webservice@unops.org

New clarification added: Dear Sir/Madam,On Section 111 Returnable Application forms, are we suppossed to fill Form A: Joint Venture Partner Information Form if you are a Private Limited Company and not a Joint Venture.Answer: Form A is only required when a submission is made as part of consortium, association and or joint-venture. In case no joint-venture formed, the form should still be submitted indicating ‘not applicable’ remark

Edited on: 31-May-2019 12:43

Edited by: webservice@unops.org

New clarification added: 1. The list of destination countries and corresponding services are not sufficient to provide a submission. Would you be able to provide more clarity on the items and quantity for each country eg Lot 1, 10 units BSC to Cambodia, 5 units to Myanmar etc2. Can you accept offer with prices ex-works Singapore?Answer: · Applicants must be capable provide item and services in the “List of countries of TB diagnostics by UNOPS Stop TB-GDF” word document uploaded in the “Documents” section of the e-Sourcing that contains the list of countries to which GDF have made deliveries of TB diagnostics products, in the period up to December 2018.· Applicants are not requested to provide any prices for the pre-qualification process. Please refer to the Section II Schedule of requirements, where it says that a subsequent step of this prequalification process, prequalified suppliers will be invited to participate to an Invitation to Bid (ITB) with price offers for the list of accepted laboratory supplies products.

Edited on: 31-May-2019 12:42

Edited by: webservice@unops.org

New clarification added: 35. In the Mandatory PQ Questionnaire, it is indicated that we should attach files such as our GDP certificate. However, we don't see an icon to click on and attach such a file, we just see an icon to include a link in our feedback. Can you please explain how we can attach documents per relevant question? Or should we only attach documents under 'Document Checklist' section of the Vendor Submission? Answer: GDP certificate is uploaded through ‘Document Checklist’ section. PQ Mandatory Questionnaire mostly requires an answer either with ‘Yes’/‘No’ or short text without requiring any attachments. All relevant submission of documents under the tender is requested in the ‘Checklist’ section and should be submitted through this section.

Edited on: 31-May-2019 12:41

Edited by: webservice@unops.org

New clarification added: 34. For all gloves (RFQ items 293 till 301), please indicate the following: 1. Is the requested thickness applicable for the palm or finger of the glove?2. Please note that the requested thickness (0.3mm or 0.35mm) is excessive, there are gloves available that do meet the required EN/CE norms but have a lower thickness. Please indicate what is leading: conformity with the requested norm or conformity with the requested thickness3. Please also indicate if the requested thickness is based on single or double measurement of the gloveAnswer: · The thickness requested for all gloves (items 293 – 301) are for both, palm and fingers.· The thickness is (0.3mm or 0.35mm) as indicated in Annex 5 Lot 1 Detailed Technical Specifications Bid Form in each technical specification per item.· The requested thickness is based on single measurement of the glove.

Edited on: 31-May-2019 12:40

Edited by: webservice@unops.org

New clarification added: LOT 1 / Item 144Are the bijou bottles required? Only they have capacity of 28mL and metal caps?Or laboratory bottles with PP screw cap are also acceptable?Please note that Bijou bottles are not made of borosilicate glass but of soda-lime glassAnswer: · Yes, universal bottles are required.· Correct, we want universal bottles with the capacity of the bottles are 28 ml and the screw cap is made of aluminum or better metal material with internal seal made of rubber as per indicated in the Annex 5 Lot 1 Detailed Technical Specifications Bid Form· The bottles must be transparent type 1 borosilicate glass as describe in the Annex 5 Lot 1 Detailed Technical Specifications Bid FormLOT 1 / Item 145Are the spare caps for Items 144 & Item 451 required?For Item 451 of 50mL no metal caps are available but normal PP screw caps.Answer: Yes, spare caps for items 144 and 451 are required.For item 451 Glass bottle 50 ml the screw caps must be made of aluminum as indicated in the Annex 7 Lot 2 Detailed Technical Specifications Bid Form

Edited on: 31-May-2019 12:38

Edited by: webservice@unops.org

New clarification added: 32. Regarding Form C: Technical application form: please explain why we have to list all suppliers that will be providing goods/services under this contract, since the names of these suppliers are already mentioned in columns G and H of the Technical Bid Form? Answer: The standard template of Form C requests the list of subcontractors/ suppliers/ parties that carries out work for a contractor. If you provide this information in other sections of your bid i.e. columns G & H, then there is no need to duplicate it in the Form C.

Edited on: 31-May-2019 12:36

Edited by: webservice@unops.org

New clarification added: 31. With regards to Form A: Joint Venture Partner Information Form: please confirm that this only needs to be filled out and submitted if our company is part of a Joint Venture / Consortium / Association. If we aren't part of such an organization structure, should we attach an empty form with remarks 'not applicable'?Answer: Form A is only required when a submission is made as part of consortium, association and or joint-venture. In case no joint-venture formed, the form should still be submitted indicating ‘not applicable’ remark.

Edited on: 31-May-2019 12:34

Edited by: webservice@unops.org

New clarification added: 28. As per your earlier clarification on question 15, stating that ISO 9001 is the minimum requirement and ISO 13485 should be provided if available: Please confirm that for generic lab reagents (so not the Drug Susceptibility Tests), ISO 9001 suffices, also since ISO 13485 is applicable for medical products while lab reagents can be used for multiple purposes and aren't medical products by nature. Answer: As indicated in the response to the question 15, please provide ISO 9001 certificates and/or ISO 13485 certificates if available.

Edited on: 28-May-2019 14:22

Edited by: webservice@unops.org

New clarification added: 27. For items 169 – 173: Please clarify if the requirement of being “Autoclavable at 121°C” is needed for filter tips that are already packaged sterile in boxes of 96 pcs? 27. For items 169 – 173: Please clarify if the requirement of being “Autoclavable at 121°C” is needed for filter tips that are already packaged sterile in boxes of 96 pcs?Answer: Yes, confirmed. One of the requirements for filter tips is “Autoclavable at 121°C”. If the product offered is not Autoclavable at 121°C, please explain.

Edited on: 28-May-2019 14:19

Edited by: webservice@unops.org

New clarification added: 26. For item 160: Please confirm if the required DIN13132 standard for Glass petri dishes is correct. While the main specification is for Plastic sterile single use petri dishes.Answer: Please ignore that row as it applies to the glass petri dish item. Thanks for pointing it out and apologies for the typo.

Edited on: 28-May-2019 14:17

Edited by: webservice@unops.org

New clarification added: 29. Please confirm that for the single channel pipettes (for instance item 161 – “106053 Single channel pipette 1 - 10 µl”) the requested specification “Provided with automatic tip-eject feature”, means a system/feature that removes pipette-tips with no direct physical contact by the operators hands, and so is met by a manual operated tip-ejection system/feature.Answer: Confirmed.

Edited on: 28-May-2019 14:12

Edited by: webservice@unops.org

New clarification added: Hi,Once we submit all the documents including the forms - the documents will be used for official use only and will not become public information at any point, correct?Answer: That is correct. All submissions/ bids made to UNOPS are treated highly confidential and used for offical UNOPS purposes. The content of the submission/ bid is not disclosed publically or to any third party. As per UNOPS corporate policy on Information Disclosure, UNOPS only discloses public procurement information – e.g solicitation notices and contract awards – in line with it’s procurement principles of transparency and accountibility.

Edited on: 27-May-2019 11:35

Edited by: webservice@unops.org

New clarification added: Lot 2 Items 489 to 494 It is not clear for what items (autoclaves) the reverse osmosis water purification system is required.Should it be a central feeding all autoclaves mentioned in the tender if they are in the same building?Answer: The reverse osmosis water purification is required for Lot 1:Item number: 341 GDF code: 106116 Benchtop autoclave 80 lt The reverse osmosis water purification is required for Lot 2:Item number: 464 NEW ITEM 15.1 Benchtop autoclave 40 litresItem number: 473 NEW ITEM 15.10 Vertical autoclave 40 ltItem number: 481 NEW ITEM 15.18 Vertical autoclave 80 lt The reverse osmosis system allows to produce "Type II laboratory grade water" suitable for all kind of autoclaves and for the washer disinfector. The listed 4 autoclaves (2 of 80 liters and 2 of 40 liters) can each be easily satisfied with a purification system that produces 60 liters of purified water per hour.

Edited on: 24-May-2019 16:13

Edited by: webservice@unops.org

New clarification added: 25. Regarding your feedback on our earlier question 20 (about recognition by a GHTF founding member): you indicated that all products in both LOT 1 and LOT 2 have to be cleared by at least one of the 5 regulatory authorities as specified. However:1. In Annex 3 - paragraph 3, it is stated that all diagnostic products shall be cleared by at least one of the 5 regulatory authorities. A lot of products in LOT 1 and LOT 2 are diagnostic products, but a lot of items are more general lab items that don't qualify as diagnostic products. Therefore, it would be most helpful if you indicate exactly which items need to have a CE certificate or Declaration of Conformity (since in practice, this is the most common one of the 5 regulatory authorities). If all items have to be CE marked, this would be impossible since CE marking simply doesn't apply for all items in this tender.Answer: The applicant may provide the clearances (declarations of conformity) for the items in both lots 1 and 2 of Annex 1 UNOPS StopTB-GDF Products list, that they have. For the items for which the applicant does not have such a clearance, the applicant may provide justification for the same in the:· Annex 4 Lot 1 Products Technical Bid Form: for Lot 1· Annex 6 Lot 2 Products Technical Bid Form for Lot 22. Furthermore, we received the following feedback:Please note that the conformity of the recognition by GHTF founding member countries is requested for all items. However, the organisation GHTF no longer exists, and has been permanently replaced by the IMDRF (http://www.imdrf.org/ghtf/ghtf-archives.asp). Please advise on this, as we need clarity on the confirmed quality norm on product level. On manufacturer/supplier level it is clear now which ISO certification is applicable, but on product level it is still unclear. Answer: Indeed the IMDRF is continuing the functions of the GHTF. The applicant may provide the clearances (declarations of conformity) as specified in Annex 3 UNOPS StopTB-GDF Technical Requirements for Medical Devices, section 3 “Compliance with regulatory requirements” for the items in both lots 1 and 2 of Annex 1 UNOPS StopTB-GDF Products list, that they have available. For the items for which the applicant does not have such a clearance, the applicant may provide justification for the same in the:• Annex 4 Lot 1 Products Technical Bid Form: for Lot 1• Annex 6 Lot 2 Products Technical Bid Form for Lot 2

Edited on: 24-May-2019 16:07

Edited by: webservice@unops.org

New clarification added: Dear Procurement-Team,Kindly let us know of the importance of delivery time & stock level of this inquiry:Is there a maximum accepted and/or a average expected lead-time for the individual products or product groupsPlease let us know whether it is a mandatory requirement to keep stock of some of the equipment for a possible urgent/emergency requirementThank you in advance for answering the clarifications!Answer: Please note that for this prequalification process, delivery lead time and stock availability of products are requested for information gathering and will not be use for the technical evaluation. The criteria used for the technical evaluation are presented in the section II schedule of requirements, article 4.3.Thus, please provide the delivery lead time you can commit for each product offered and if you have stock availability for immediate offtakeIt is not a mandatory requirement to keep stock of equipment for a possible urgent/emergency requirement

Edited on: 24-May-2019 13:45

Edited by: webservice@unops.org

New clarification added: Hi,Thank you very much for your efforts, according to the below answer - if we did not have voluntary participation who can we fill the below.UN Global Compact Participant:Participant Number: Participant Number: Date of last COP: Level of COP:Answer: This section requests details of your voluntary participation in the UN Global Compact. The UN Global Compact is a voluntary international corporate citizenship network launched to support both the private sector and other social actors’ participation in the advancement of responsible corporate citizenship and universal social and environmental principles to meet the challenges of globalization. https://www.unglobalcompact.org/. UNOPS expects its suppliers to support the United Nations Global Compact and its principles. Answer: no one else can fill this information except the Applicant itself, it is the applicant who has the information about thier UN Global Compact. If you don't have this information write 'not applicable' or leave them blank.

Edited on: 22-May-2019 15:13

Edited by: webservice@unops.org

New clarification added: Please let me know if you could get back to me regarding all questions I asked.Answer: please find the answers as above.

Edited on: 22-May-2019 11:33

Edited by: webservice@unops.org

New clarification added: 24. We thank you for your feedback on our earlier question 19, for item 293 till 295 it is now clear. However, please confirm that also for item 296 till 298, 240mm length is acceptable since this is the common norm in the market. For item 293 till 295 you indicated that 240mm is accepted, but we don't see your firm confirmation for item 296 till 298, although also for these items it is common to use 240mm length. Answer: Yes, confirmed.

Edited on: 22-May-2019 11:31

Edited by: webservice@unops.org

New clarification added: regarding (Lot 2 – item 418/419/420) in the product list -we will quote for 1 item that does the reading, washing, incubating, dispensing, shaking, sample dilution, Liquid level detection, and sample Barcode reading - if we get the approval from your side to supply the unit - the end user will require consumables so he can run the tests please let me know if the consumables will be requested from you directly or from the end user.We will supply the unit with standard items but after that the customer should order the consumables. Answer: The GDF client (end user) will request the diagnostics equipment, reagents, consumables and services to GDF. Then StopTB GDF will do the procurement of those items on their behalf.

Edited on: 22-May-2019 11:28

Edited by: webservice@unops.org

New clarification added: regarding (Lot 2 – item 418/419/420) in the product list -we will quote for 1 item that does the reading, washing, incubating, dispensing, shaking, sample dilution, Liquid level detection, and sample Barcode reading - please confirm if the warranty requested is two years.Answer: Yes, confirmed.

Edited on: 22-May-2019 11:22

Edited by: webservice@unops.org

New clarification added: For all forms should we use our company head letter and stamp the document, or only sign the document without using our head letter, moreover please let me know if any original document is required.Answer: there is no strict requirement on the usage of the letterhead, you may use your company letterhead; it is however not permissible to change the content (in terms of standard clauses) of any form as provided by UNOPS through eSourcing system. The documents shall be signed and stamped in all relevant sections and must be submitted to UNOPS through the UNOPS eSourcing system. There is no requirement to submit original documents/bid.

Edited on: 22-May-2019 11:20

Edited by: webservice@unops.org

New clarification added: Question 9: we are a global company and we supply our units globally but this is our first time with you, please let me know what is the below:UN Global Compact Participant:Participant Number: Participant Number: Date of last COP: Level of COP:Answer: This section requests details of your voluntary participation in the UN Global Compact. The UN Global Compact is a voluntary international corporate citizenship network launched to support both the private sector and other social actors’ participation in the advancement of responsible corporate citizenship and universal social and environmental principles to meet the challenges of globalization. https://www.unglobalcompact.org/. UNOPS expects its suppliers to support the United Nations Global Compact and its principles.

Edited on: 22-May-2019 11:09

Edited by: webservice@unops.org

New clarification added: Question 1: Annex 7 Lot 2 Detailed Technical Specifications Bid Form – do I put the price for Lot 2 (418/419/420) next to Quantity to be quoted: 1 piece. Keep in mind that our unit it covers 3 items (418/419/420) as the product does the reading, washing, incubating, dispensing, shaking, sample dilution, Liquid level detection, and sample Barcode reading.Answer: No, the financial part is not part of the Pre-Qualification process. In the PQ process, the applicants are not requested to provide any price for product. Please refer to the Section II Schedule of requirements, where it says that a subsequent step of this prequalification process, prequalified suppliers will be invited to participate to an Invitation to Bid (ITB) with price offers for the list of accepted laboratory supplies products. Question 2: I’m the Applicant Representative, should I sign all the documents, or I can ask someone else to sign it, please advise.Answer: Authorized Applicant representative shall sign the documents. Question 3: I do believe you need samples as requested, please let me know if this is also required for medical equipment, as you know we will quote for Lot 2 (418/419/420) in one item as the product does the reading, washing, incubating, dispensing, shaking, sample dilution, Liquid level detection, and sample Barcode reading. so it’s an ELISA automated system and it’s not normally required as a sample because it’s a machine.Answer: Please refer to the section II Schedule of Requirements, at paragraph 4.4 a. (Page 10) that states the following: The list of products for which a sample must be sent by Applicants for testing will be communicated by UNOPS/stopTB-GDF after the technical evaluation is completed. Applicants should hold samples ready for dispatchSamples will be sent by the Applicants directly to the qualified laboratory appointed by UNOPS/StopTB-GDF (the exact address will be communicated).Samples selected will be weighting less than 15 kgs each that can be shipped as general cargo. Applicants will manage importation duties and importation process if any. Question 4: I did not find the final date of where you will need the items, is it in 2019 or not – in case we awarded the supply.Answer: In terms of the samples under this Pre-Qualification process applicants will be requested to provide samples for only 25 selected products, after the technical evaluation is completed. It is estimated to be during the period of July-August 2019. StopTB Partnership- GDF will procure the items once the Long-term Agreement (LTA) is finally signed with the awarded supplier after the ITB process. The ITB process is estimated to be finalized by the 31st of December 2019.Question 5: I did not find what would be the payment terms, and the offer validity.Answer: The payment terms, and the offer validity are not part of this Pre-Qualification process. The payment terms, lead time of production per product and the offer validity are part of the subsequent step: Invitation to Bid (ITB).Question 6: only to double check, our quote will be Ex-works I believe you have freight forwarder that will collect the items, please confirm.Answer: Correct. Please note that the financial part is not part of the Pre-Qualification process. In the PQ process, the applicants are not requested to provide any price for product. Please refer to the Section II Schedule of requirements, where it says that a subsequent step of this prequalification process, prequalified suppliers will be invited to participate to an Invitation to Bid (ITB) with price offers for the list of accepted laboratory supplies products. Question 7: In case we submit. but there is a missing document would you let us know or it's a direct rejection.Answer: Applicants are requested to provide the document listed in the “checklist” section of the e-sourcing platform. Please make sure to go line by line so applicant do not miss any document asked in this Pre-Qualification process. Question 8: [insert name of Applicant] is it me the representative for my company the manufacturer, please advise.Answer: Name of the Applicant means the legal business name of the company and not the name of the individual representative. Applicant is referred to a private, public or government-owned legal entity or any association with legal capacity to bid and enter into a binding Contract with UNOPS.

Edited on: 22-May-2019 11:09

Edited by: webservice@unops.org

New clarification added: Please could confirm if Pre-Qualification documents(Technical) only are to be submitted on the stated deadline or is the financial part going to be submitted as well?Answer: Yes, the technical documents must be submitted by the deadline of the Pre-Qualification process: 2019-06-14 10:00 UTC. No, the financial part is not part of the Pre-Qualification process. In the PQ process, the applicants are not requested to provide any price for product. Please refer to the Section II Schedule of requirements, where it says that a subsequent step of this prequalification process, prequalified suppliers will be invited to participate to an Invitation to Bid (ITB) with price offers for the list of accepted laboratory supplies products.

Edited on: 22-May-2019 10:33

Edited by: webservice@unops.org

New clarification added: 20. In column S of Annex 1 (Products List), at all items it is mentioned that they should be recognized by GHTF founding member countries, while in Annex 3 (paragraph 3) it is stated that 'Diagnostics products shall be cleared by at least one of the 5 regulatory authorities listed below and comply with the corresponding market release certificates as described in the GHTF for market clearance'. Since a lot of items in the Products List are not diagnostic products by nature, can you please specify for which items the recognition by the GHTF founding member countries applies? Answer: We understand that you are referring to the column R “conformities” and not column S “Distributor” referring the ISO certification of the distributors in the Annex 1 UNOPS StopTB-GDF Products list. We confirm that all products, in Lot 1 and Lot 2, except training, installation and maintenance must be cleared by at least one of the 5 regulatory authorities as specified in Annex 3 UNOPS StopTB-GDF Technical Requirements for Medical Devices and in the document Section II Schedule of requirements

Edited on: 22-May-2019 10:27

Edited by: webservice@unops.org

New clarification added: 19. Regarding item 293 till 295, as well as item 296 until 298: right now, a length of 280mm is requested. However, we can see that the previous product in the LTA had a length of 240mm, which is also more common than 280mm and as far as we can see, 240mm length would suffice. Therefore, can you please confirm that 240mm length is acceptable? Answer: For items 293 till 295 in Lot 1, the length of 240mm is acceptable293 106345 Latex gloves size S294 106346 Latex gloves size M295 106347 Latex gloves size L

Edited on: 20-May-2019 17:21

Edited by: webservice@unops.org

New clarification added: In Annex 4 & 5 the items from Lot 1 are swapped - Items 121 to 125.Answer: Noted and apologies. Please add the information as it is. The products will be evaluated with the swapped order number (121-125) in Annex 5: Lot 1 Detailed Specifications Bid Form.

Edited on: 20-May-2019 17:19

Edited by: webservice@unops.org

New clarification added: 18. Please confirm that instead of a Manufacturer Authorization Form (MAF), a Supplier Authorization Form (SAF) for third party goods suppliers is also acceptable.We have prepared a SAF template for your approval, please see below: "We [insert complete name of Supplier], who are official suppliers of [insert type of goods], manufactured by, [insert full name of manufacturer], do hereby authorize authorize [insert complete name of Applicant] to submit a bid the purpose of which is to provide the following goods, supplied by us [insert name and or brief description of the goods], and to subsequently negotiate and sign the contract. We hereby extend our full guarantee and warranty in accordance with Clause 4.5 of the General Conditions of Contract for the provision of Goods, with respect to the goods offered by the above firm. Signed: [insert signature(s) of authorized representative(s) of the supplier] Name: [insert complete name(s) of authorized representative(s) of the supplier] Title: [insert title] Dated on ____________ day of __________________, _______ [insert date of signing]"Answer: Due to difficulties to track and trace the origin of the product and related technical and shipping documentation from another distributor of the applicant and not from the manufacturer directly we strongly prefer the MAF rather than the SAF.

Edited on: 20-May-2019 17:17

Edited by: webservice@unops.org

New clarification added: Dear Sir/Madam,What documents need to be submitted for each of the offered item?* Equipment: ISO, CE or DoC, Specification or Brochure, User Manual, MAF* Reagnents: ISO, Specification or Brochure, MSDS for hazardous only, MAF* Consumables: ISO, CE or DoC, Specification or Brochure, MAF* Autoclaves: ISO, CE or DoC, Specification or Brochure, User Manual, MAF* BSC: ISO, CE or DoC, Specification or Brochure, User Manual, MAFHow should all this be data be submitted? Please consider the volume is super high and attachments one by one somewhere are neither feasible nor manageable.Please propose a way to submit the files in zip format.Answer: The applicant must follow the instructions given in the Section II: schedule of requirementsSECTION 3: SPECIFIC INSTRUCTIONS FOR APPLICANTS3.5. Submission of Bids by Applicants: For Lot 1 and Lot 23.6. Documents to be submitted with the BidsSECTION 4: PREQUALIFICATION PROCESS4.1. Evaluation of Applicant eligibility4.2. Evaluation of Applicant qualification4.3. Technical evaluation of products offeredThe applicant can follow the “Checklist” section in the e-sourcing platform as guide of full documentation needed for submission.All bids must be submitted through UNOPS eSourcing system. Attachments of the submissions can be uploaded in a zip format having mutiple files.

Edited on: 20-May-2019 17:14

Edited by: webservice@unops.org

New clarification added: We do not find "List of personal protective items in Lot 1 and Lot 2" in the DocumentsAnswer: the document is uploaded in the 'Documents' section of the eSourcing system.

Edited on: 20-May-2019 17:08

Edited by: webservice@unops.org

New clarification added: 23. As reaction to your feedback provided on our earlier question: we have additional examples of brands currently mentioned in the GDF TB diagnostics ordering list, which do not comply with your requirement to have ISO 9001 and/or ISO 13485:item 65, 279 & 281 , supplier Contacto --> company has no ISOitem 13, supplier Medax --> company has no ISOPlease indicate how we should deal with this, since the requested specifications seem to be based on the product currently being procured under the existing LTA but the existing sources do not meet your ISO requirement. Therefore, please indicate what is leading: your ISO norms or the full compliancy with the requested specifications. Answer: The current ordering list might have many typos, apologies in advance. The GDF ordering list has not been referenced in the PQ documentation as GDF day to day try to update that document. Reason why there are several versions.The applicant should be looking at the up to date total technical information given in the Annex 1 UNOPS StopTB-GDF Products list under the “Documents” given in this PQ tender. Please see that technical evaluation will be done based on the up to date technical specifications given in the tender in the Annex 5 for Lot 1 and Annex 7 for Lot 2.Annex 5 Lot 1 Detailed Technical Specifications Bid Form.Annex 7 Lot 2 Detailed Technical Specifications Bid Form.

Edited on: 20-May-2019 17:04

Edited by: webservice@unops.org

New clarification added: Hi,I did not recieve an answer for the belwo question:regarding (Lot 2 – item 418/419/420) in the product list -we will quote for 1 item that does a reading, washing, incubating, dispensing and shaking at the same time All in one product. Please confirm that you need the item for all mentioned countries or not I can see there are 90 countries so you need 90 units please advise urgently, and for the installation can we train the lab tech at our German or U.S office or we should travel to each country to do the installation.Please confrim from where I can get the below.Joint Venture Partner Information FormApplication Submission FormPrevious experience FormFinancial Situation FormAnnual Turnover FormManufacturer’s Authorization FormApplication Declaration FormConflict of Interest FormDispute Details FormNo Adverse Action Confirmation FormAnswer: please see the aswer is posted above.

Edited on: 20-May-2019 16:59

Edited by: webservice@unops.org

New clarification added: I did not recieve an answer for the belwo question:regarding (Lot 2 – item 418/419/420) in the product list -we will quote for 1 item that does reading, washing, incubating, dispensing and shaking at the same time All in one product. Please confirm that you need the item for all mentioned countries or not.Another question:I have question regarding the installation can we train the lab technician at our office in the UK or Germany or the U.S and then they can install the units we can send the invitation letter for them so they can process the visa, or we should travel to each country for installation, for many countries we can do that via business partners, so please advise - I only see QTY is 1 - so is it 1 for this project or 1 per country - and please confirm a number of countries and units to be ordered per year, and please let me know from where I can get the below documentsJoint Venture Partner Information FormApplication Submission FormPrevious experience FormFinancial Situation FormAnnual Turnover FormManufacturer’s Authorization FormApplication Declaration FormConflict of Interest FormDispute Details FormNo Adverse Action Confirmation FormAnswer: please see the aswer is posted above. Avoid sending multiple reminders.

Edited on: 20-May-2019 16:54

Edited by: webservice@unops.org

New clarification added: Please let me know from where I can get the below forms - and I see 97 countries please confirm because for the Lot 2 (items 418/419/420) we will consolidate that with one Automated item becuase you don't need to request 3 items as we have 1 automated system that it's used globally for the TB and other ELISA test, as we are the best in the world in ELISA automaton, how many units in three years you may require, moreover I have question regarding the installation can we train the lab technician at our office in the UK or Germany or the U.S and then they can install the units we can send the invitation letter for them so they can process the visa, or we should travel to each country for installation, for many countries we can do that via business partners, so please advise - I only see QTY is 1 - so is it 1 for this project or 1 per country - and please confirm a number of countries and units to be ordered per year.Joint Venture Partner Information FormApplication Submission FormPrevious experience FormFinancial Situation FormAnnual Turnover FormManufacturer’s Authorization FormApplication Declaration FormConflict of Interest FormDispute Details FormNo Adverse Action Confirmation FormAnswer: the returnable form is available under the 'Documents' section of the eSourcing system. The 97 countries are the list of countries to which GDF have made deliveries of TB diagnostics products, in the period up to December 2018 to give you an idea of our client’s locations.· The price for all the items in Lot 1 and Lot 2 should be at the global level, for all low- and middle-income countries (according to World Bank 2019 fiscal year classification).For the Lot 2 (items 418/419/420): The applicant can offer its available product and mention that it covers 3 items (418/419/420) as the product does the reading, washing, incubating, dispensing and shaking at the same time. All in one product.The ELISA equipment is a new addition in the GDF diagnostics catalog, therefore we do not have estimates of the volume as of now. The price offered should be for 1 unit. The GDF clients then request as many units as needed through GDF procurement process.Installation of the ELISA equipment and training should be at the client’s premises whether directly by the applicant or by the applicant’s business partners. The GDF clients are all low- and middle-income countries (according to World Bank 2019 fiscal year classification).

Edited on: 20-May-2019 16:49

Edited by: webservice@unops.org

New clarification added: Thank you very much for your answer (The applicant can offer its available product and mention that it covers items 418/419/420)New question please let me know do you require the item to all listed countires or it's only one item and that's it.Answer: Yes, the applicant should be able to deliver all the items offered to all the listed countries and to all low- and middle-income countries if and when an order is placed.Please see in the “Documents” Section of the E-sourcing the list of countries to which GDF have made deliveries of TB diagnostics products, in the period up to December 2018 to give you an idea of our client’s locations.

Edited on: 20-May-2019 16:40

Edited by: webservice@unops.org

New clarification added: 22. Regarding item 21 (GDF code 106493) from LOT 1 and item 414 (GDF code NEW ITEM 7.3) from LOT 2: these are both solar panel systems specifically dedicated for us with the GeneXpert system (item 21) or the Human TB-Lamp system (item 414). Both the GeneXpert system and the Human system itself is not included in this tender, and the solar panel system is an accessory for those systems. Therefore, to ensure that a 100% compliant and workable solar panel system is offered, these items should not be part of this tender in our view since they are spare parts for systems for which a separate LTA already exists with both Human and Cepheid. Answer: The annex 5 “Lot 1 Detailed Technical Specifications Bid Form” has been developed with complete detailed Technical Specifications for all items, including item 21: 106493 Solar panel generator system 750 W, used as optional accessory for the GeneXpert system. For more information on the GeneXpert system, please see the following link: http://www.cepheid.com/us/cepheid-solutions/systems/genexpert-systems The annex 7 “Lot 2 Detailed Technical Specifications Bid Form” has been developed with complete detailed Technical Specifications for all items, including item 414: NEW ITEM 7.3 Solar panel generator system 1.5 KW, used as optional accessory for the GeneXpert system. For more information on the Human TB-Lamp system, please see the following link: https://www.human.de/products/molecular-dx/tb-lamp/

Edited on: 20-May-2019 15:33

Edited by: webservice@unops.org

New clarification added: 21. Please note that we have concluded the following: in the GDF TB diagnostics ordering list, specific current suppliers/brands are mentioned. However, this sometimes conflicts with the requirements as stated now in the bid documents. For example, for item 9, currently brand WLD Tech is mentioned. However, this company has no ISO certiciation, while now in Annex 1 for this item ISO 13485 certification is requested. How should we interpret this? Answer: The current Electric sterilizer for loops and needles is from another brand. Apologies for the confusion. That typo will be updated in the GDF ordering list.Please see that technical evaluation will be done based on the up to date technical specifications given in the tender in the Annex 5 for Lot 1 and Annex 7 for Lot 2Annex 5 Lot 1 Detailed Technical Specifications Bid FormAnnex 7 Lot 2 Detailed Technical Specifications Bid Form

Edited on: 20-May-2019 15:23

Edited by: webservice@unops.org

New amendment added #3: To add the 'List of personal protective items in Lot 1 and Lot 2' as an attachement under the documents Section of the tender as requested during tender clarification process.

Edited on: 17-May-2019 14:15

Edited by: webservice@unops.org

New clarification added: Hi I sent the below and I did not get an answer yet - please adivse.Question regarding (Lot 2 – item 418/419/420) in the product list - we have 1 full automatic unit that we manufacturer and distribute it globally which is Full ELISA automation system (Reading, washing, incubating, dispensing and shaking) all in unit - so please let me know if we can quote our unit so you can benefit our technology, we are the world-class manufacturer of ELISA automation system.Please let me know what do you think because it's cost, time, quality and technological efficient for you to buy 1 unit that does everything required instead of requesting 3 different systems which are not automatic, moreover please confirm that you need the item for all mentioned countries. I will be happy to hear from you and thank you very much for your time.Answer: please see the clarification provided above.

Edited on: 17-May-2019 10:46

Edited by: webservice@unops.org

New clarification added: Question regarding (Lot 2 – item 418/419/420) in the product list - we have 1 full automatic unit that we manufacturer and distribute it globally which is Full ELISA automation system (Reading, washing, incubating, dispensing and shaking) all in unit - so please let me know if we can quote our unit so you can benefit our technology, we are the world-class manufacturer of ELISA automation system. Please let me know what do you think because it's cost, time, quality and technological efficient for you to buy 1 unit that does everything required instead of requesting 3 different systems which are not automatic, moreover please confirm that you need the item for all mentioned countries. I will be happy to hear from you and thank you very much for your time.Answer: For the Lot 2 (items 418/419/420): The applicant can offer its available product and mention that it covers items 418/419/420) as the product does the reading, washing, incubating, dispensing and shaking at the same time. All in one product.

Edited on: 17-May-2019 10:41

Edited by: webservice@unops.org

New clarification added: 17. In Annex 3 at chapter 7, mention is made that for PPE items, the supplier/manufacturer shall provide the copies of certificates for protective clothing to prove compliancy with ISO 13688:2013 and ISO 16900-7:2015. In an earlier stage, it was already clarified that we don't have to submit these certificates as per the Checklist section. However, we would also need to know to exactly which items the mentioned ISO norms apply since there is no Sub-Lot 'Personal Protective Equipment' in this tender. So please list for which items the mentioned ISO norms do apply in order for us to take this into account. Answer: The document called: “List of personal protective items in Lot 1 and Lot 2” has been added in the “Documents” section of the e-sourcing platform to list the items for which the ISO 13688:2013 and ISO 16900-7:2015 norms apply.

Edited on: 17-May-2019 10:37

Edited by: webservice@unops.org

New clarification added: 15. In the Section II document at paragraph 4.3.a.i, it is indicated that 'Manufacturers of products shall be certified according to ISO 13845 or equivalent quality management system'. However, in column V ('Manufacturer') of Annex 1, at some items ISO 9001 is also mentioned, so please confirm that we should look at column V of Annex 1 to see the requested ISO certification per item.Answer: The ISO 9001 certificate is the minimum requirement for some products, as specified in column T. Please provide the ISO 13485 certificate if both certificates are available.16. In the Section II document at paragraph 4.3.a.ii, it is indicated that 'Manufacturers of all reagents, Drug Susceptibility Tests (DST) pure substances and chemical for laboratory shall be ISO 17025:2017 certified and meet the requirements of ISO 17034:2016'. However, the mentioned quality norms ISO 17025 and ISO 17034 are very high-end and only maintained by very few plants/suppliers worldwide. Therefore, can you please indicate for which specific items in the Sub-Lot 'Reagents' these norms apply, instead of applying it for all reagents, since also in Annex 1 in column V only at some reagents ISO 17025 and 17034 is requested (only for LOT 2 reagents)?Answer: For Drug Susceptibility Tests (DST) pure substances in the Sub-Lot Reagents it is mandatory to provide a copy of ISO 17025:2017 certificate. For all other Reagents, please provide it if available. It does not apply to other Sub-LotsPlease see the amendment done in the checklist section: 23. “Copy of ISO 17025:2017 certificate (where applicable) for manufacturers of all reagents, Drug Susceptibility Tests (DST) pure substances and chemical for laboratory”.

Edited on: 16-May-2019 15:38

Edited by: webservice@unops.org

New clarification added: 11. In the document checklist section, the following is requested at point 27: 'MSDS for all items'. Please confirm that this only applies for items in Sub-Lot 'Reagents', since for the other Sub-Lots, MSDS's are in most cases not available for products like autoclaves, lab consumables, etcetera. We know that MSDS's for non-reagent items become more and more common, but many suppliers don't have it available yet.Answer: Please submit the MSDS for all Reagents in Lot 1 and Lot 2. If available, for all other products in Lot 1 and Lot 2. The MSDS must be submitted if the product is transported in dangerous cargo.12. In the document checklist section, we don't see the option to add any other documents in addition the the requested documents. For example, we want to include a covering letter. How do we attach this together with our bid?Answer: please add additional documents as part of the returnable schedules. 13. In the document checklist section, the following is requested at point 27: 'For all products: Product photo combined with other technical information and the primary and secondary packaging with readable label information minimum in English'. Please:a.confirm that the first part of this sentence (up to 'technical information') simple refers to the product brochure, and:Answer: Correct, if available.b. Reconfirm if for every product the primary and secondary packing layout has to be shared, since not all suppliers are able to share this. What is the purpose of requesting this documentation, for example when it concerns an autoclave? Answer: For all products: Applicants must submit product photo and the primary and secondary packaging with readable label information minimum in English (in JPEG format). The purpose of having the photos is for customs clearance by our GDF clients. For product such as autoclaves, the photo of the label with product description (temperature control product number, etc.) added in the carton/pallet can be used for the autoclave and spare parts.14. In general, please confirm that all mandatory tender documents that need to be submitted are mentioned in the document checklist section of the UNOPS eSourcing platform, and that no additional tender documents are needed to be qualified. Answer: Correct, all mandatory tender documents that needs to be submitted are mentioned in the document checklist section. In the case that UNOPS/StopTB accepts only 80% of the offered products according to the technical specifications given in the tender, the applicant can submit new documentation for the alternative product. Therefore, additional documentation for the alternative product offered is needed.

Edited on: 16-May-2019 15:26

Edited by: webservice@unops.org

New amendment added #2: 1. To extend the Submission Deadline to June 14, 2019. 2. To extend the Deadline for Clarifications to June 5, 2019. 3. To amend the wording of line item 23 under the Checklist Section.

Edited on: 14-May-2019 18:31

Edited by: webservice@unops.org

New clarification added: Dear Sir/Madam, Considering the complexity of the project and the number of the required items and requested information and documentation, we would kindly ask you for a deadline extension for at least 2 additional weeks. thank you in advance!Answer: Yes, deadline has been extended to the 14.06.2019

Edited on: 14-May-2019 15:19

Edited by: webservice@unops.org

New clarification added: 10. In the document checklist section, the following is requested at point 23: 'Copy of ISO 17025:2017 certificate for manufacturers of all reagents, Drug Susceptibility Tests (DST) pure substances and chemical for laboratory'. Please confirm that this only applies for items in Sub-Lot 'Reagents'. If not, please indicate for which additional items in other Sub-Lots the ISO 17025:2017 is also required. Answer: Yes, for Drug Susceptibility Tests (DST) pure substances in the Sub-Lot Reagents it is mandatory to provide a copy of ISO 17025:2017 certificate. For all other Reagents, please provide it if available. It does not apply to other Sub-Lots. We acknowledge an error in the listing of this requirement as mandatory for all Reagents and an erratum/corrigendum will be published.

Edited on: 14-May-2019 15:16

Edited by: webservice@unops.org

New clarification added: 9. In the MAF layout, the following is stated: 'We hereby extend our full guarantee and warranty in accordance with Clause 4.5 of the General Conditions of Contract for the provision of Goods, with respect to the goods offered by the above firm.'Please elaborate on what is stated in said Clause 4.5, please provide this clause in order for manufacturers to be able to see what they will be committing to. We would appreciate to get this information ASAP to ensure manufacturers can proceed immediately.Answer: Please see below the full clause of the 4.5 section of the UNOPS General Conditions of Contract for the provision of Goods:4.5 WARRANTIES: Unless otherwise specified in the Contract, in addition to and without limiting any other 4.5 warranties, remedies or rights of UNOPS stated in or arising under the Contract, the Contractor warrants and represents that:4.5.1 The goods, including all packaging and packing thereof, conform to the specifications of the 4.5.1 Contract, are fit for the purposes for which such goods are ordinarily used and for any purposes expressly made known in writing in the Contract, and shall be of even quality, free from faults and defects in design, material, manufacturer and workmanship;4.5.2 If the Contractor is not the original manufacturer of the goods, the Contractor shall provide UNOPS 4.5.2 with the benefit of all manufacturers’ warranties in addition to any other warranties required to be provided under the Contract;4.5.3 The goods are of the quality, quantity and description required by the Contract, including when 4.5.3 subjected to conditions prevailing in the place of final destination;4.5.4 The goods are free from any right of claim by any third-party, including claims of infringement of any 4.5.4 intellectual property rights, including, but not limited to, patents, copyright and trade secrets;4.5.5 The goods are new and unused;4.5.6 All warranties will remain fully valid following any delivery of the goods and for a period of not less 4.5.6 than one (1) year following acceptance of the goods by UNOPS in accordance with the Contract;4.5.7 During any period in which the Contractor’s warranties are effective, upon notice by UNOPS that the 4.5.7 goods do not conform to the requirements of the Contract, the Contractor shall promptly and at its own expense correct such non-conformities or, in case of its inability to do so, replace the defective goods with goods of the same or better quality or, at its own cost, remove the defective goods and fully reimburse UNOPS for the purchase price paid for the defective goods; and,4.5.8 The Contractor shall remain responsive to the needs of UNOPS for any services that may be 4.5.8 required in connection with any of the Contractor’s warranties under the Contract. Please see here the full UNOPS General Conditions of Contract for the provision of Goods: https://content.unops.org/service-Line-Documents/Procurement/UNOPS-General-Conditions-Goods-2017_EN.PDF Also, please see that in the “Criteria” section of the e-sourcing, at the stage of: Eligibility and formal criteria is stated:“1.4 The applicant accepts UNOPS General Conditions of Contract see https://www.unops.org/english/Opportunities/suppliers/how-we-procure/Pages/default.aspx”

Edited on: 10-May-2019 15:42

Edited by: webservice@unops.org

New clarification added: 1. Please clarify what neeeds to be entered in the following columns in Annex 4 & 6? "Stock availability of product (on average)""Stock availability of product (for immediate offtake)"is it a yes/ no answer or delivery time in weeks or days?Answer: Stock availability of product (on average)": It is Not a “Yes/No” answer. It needs to be entered the delivery time in weeks or days to have the next stock available for that specific product. "Stock availability of product (for immediate offtake)": It is Not a “Yes/No” answer. It needs to be entered the delivery time in weeks or days to have the immediate offtake stock available (for urgent orders, such us in-country stock outs) for that specific product2. Does Annex 1 need to be filled out, or is it for information purposes only?Answer: The Annex 1 UNOPS StopTB-GDF Products list does not have to be filled out. The Annex 1 contains the products for Lot 1 and 2 and per sub-lot and is only for information purposes.3. Annex 5, group D Autoclaves This group includes a laboratory dishwasher machine (item 349- 353) 106101 Washer-disinfector) although it is specified under Autoclaves. Please confirm that the laboratory dishwasher machine/ Washer-disinfector is required and not an autoclave. Answer: An autoclave is not requested under the items number: 349-353 . The item 349 requires a Washer disinfector and the items number 350-353 are its accessories (see below)349 106101 Washer-disinfector350 106102 Net basket to wash laboratory tubes351 106103 Upper basket with washing arm to wash glassware352 106104 Upper basket with jets for washing glassware353 106105 Net basket for washing glassware. 4. Annex 7, group D Autoclaves This group includes a Reverse osmosis water purification system (item 489-494) although it is specified under Autoclaves. Please confirm that a Reverse osmosis water purification system is required and not an autoclave. Answer: An autoclave is not requested under the items number: 489-494 . The item 489 requires a Reverse osmosis water purification system and the items number 490-494 are its accessories (see below)489 NEW ITEM 15.26 Reverse osmosis water purification system490 NEW ITEM 15.27 Sediment pre-filters491 NEW ITEM 15.28 Activated carbon filters492 NEW ITEM 15.29 Ion cartridges493 NEW ITEM 15.30 Reverse Osmosis membrane494 NEW ITEM 15.31 Post-filtration module

Edited on: 10-May-2019 15:31

Edited by: webservice@unops.org

New clarification added: Dear Sir/Madam,Is it possible to bid for only ONE specific country from the list? Or, is the supply of laboratory equipment at global level (ability to supply to all the countries listed in the attached document)?Answer: No, it is not possible to bid for only ONE specific country. The supply of laboratory equipment should be at global level, for all low- and middle-income countries (according to World Bank 2019 fiscal year classification). Please see the “List of countries of TB diagnostics by UNOPS Stop TB-GDF” in the “Documents” section of the eSourcing that contains the list of countries to which GDF have made deliveries of TB diagnostics products, in the period up to December 2018.

Edited on: 10-May-2019 10:26

Edited by: webservice@unops.org

New clarification added: Dear Sir/MdamWe are interested in partcipating for this tender and I would like to know whether we have to bid for all the items under one lot or we can choose the items accordingly as our product portfolio doesn't cover all the items that you called for tender.Answer:Please, refer to Section II document: Schedule of requirements, paragraph 3.5 that states:For Lot 1: Applicants MUST submit a Bid for ALL the products of the Lot 1. The total products quantity in Lot 1 is 407. Failure to provide a Bid for a product of Lot 1 may lead to the rejection of the application for Lot 1.For Lot 2: Applicants are STRONGLY requested to submit a Bid for all the products of the Lot 2. Total products quantity in Lot 2 is 123. The Applicants can offer at least ONE product for Lot 2.

Edited on: 06-May-2019 13:40

Edited by: webservice@unops.org

New clarification added: 5. Annex 3 states at paragraph 12: copy of warranty should be provided for all equipment and clearly specify the number of years covering the diagnostic product and its components. Can you please explain what is meant here, do you mean that a copy of the warranty policy should be submitted for all equipment in the bid, or do you mean that the warranty policy document should be included at time of delivery of the equipment?Answer: No, a copy of the warranty policy should not be submitted for all equipment with the bid. Please refer to the checklist section of the e-sourcing platform for the list of documents to provide with your bids. 6. In the Section II document at paragraph 4.4, mention is made of the testing of samples for which 25 items will be randomly selected. Can you please indicate if in the 25 items, also equipment (like autoclaves or BSCs) might be requested, or will this only be reagents and diagnostic items or lab supplies? We would appreciate to have this information to be aware upfront of the costs involved in this exercise.Answer: Please refer to the section II Schedule of Requirements, at paragraph 4.4 a. (Page 10) that states the following:Samples will be sent by the Applicants directly to the qualified laboratory appointed by UNOPS/StopTB-GDF (the exact address will be communicated).Samples selected will be weighting less than 15 kgs each that can be shipped as general cargo. Applicants will manage importation duties and importation process if any.As autoclave and BSC weight more than 15kg, no sample will be requested for these products 7. In the Section II document at paragraph 3.6, there is a difference between the given example for saving the users manuals (point a) and the datasheets (point b), since at the example of how to save the datasheets (point b), no underscore symbol is indicated in the example. Same applies at point c (all other products). Please confirm if this is correct and let us know how to save all documents to prevent issues later on.Answer: Please ignore the underscore. The main point is to have the number of the product as indicated in the Annex 1 (for lot 1 and lot 2) + the Product name + manual /the data sheet / the MSDS / PP / SP as applicable 8. Please confirm if it is allowed to propose several options at one item.Answer: No, suppliers are requested to propose only one option per item in their bid. However, after the first round of technical evaluation of products offered by supplier by UNOPS/StopTB-GDF, suppliers could be requested to submit an alternative product under strict rules and conditions. Please refer to paragraph 4.3b in the Section II document.

Edited on: 01-May-2019 16:47

Edited by: webservice@unops.org

New clarification added: 4. Annex 3 states at paragraph 8: The language of the label and the product documentation should be in English, French, Spanish and Russian plus optional two further languages e.g. Portuguese and Chinese (upon request). Please be informed that not all manufacturers can adhere to these language requirements, since mainly the Russian language is not standard. Please indicate how to treat this (same applies to paragraph 10 of annex 3).Answer: The language of the label and the product documentation and the Instructions for Use/product manuals should be minimum in English. As UNOPS/StopTB-GDF supplies diagnostics products to ALL low and middle in-come countries we prefer to have also in Spanish, French, Russian or any other language upon request.

Edited on: 01-May-2019 16:45

Edited by: webservice@unops.org

New clarification added: 1. It would be highly appreciated if the context of this PQ exercise is further explained. As far as we can see, we don’t have to quote prices in this stage, and Section II document states that ‘As a subsequent step of this prequalification process, prequalified suppliers will be invited to participate to an Invitation to Bid (ITB) for the list of accepted laboratory supplies. Can you please indicate how many suppliers are planned to be prequalified, and within what timeframe after this PQ process the ITB can be expected? If we understand correctly, it might be that we become a prequalified supplier of UNOPS during 3 years but actual PO’s will only be sent in if our bid during the upcoming ITB is found to be the most competitive?Answer:Correct, suppliers are not required to provide prices for products offered during this prequalification process. Only suppliers prequalified for a list of products accepted by UNOPS/StopTB-GDF during this prequalification process will be invited to participate to an invitation to Bid (ITB) for the list of products accepted and for which suppliers will be requested to provide a price offer and a lead time per product.There is no number of suppliers planned to be prequalified. All suppliers that pass the eligibility and qualification criteria and are compliant with the following criteria will be prequalified for a specific list of products:For Lot 1:- Criterion n°1: The Applicants have offered a product for each of the items of Lot 1- Criterion n°2: 100% of the products offered by Applicants are accepted by UNOPS/StopTB-GDFor Lot 2:- Criterion n°1: The Applicants have offered at least one product for Lot 2- Criterion n°2: 100% of the products offered by Applicants are accepted by UNOPS/StopTB-GDF For more details, please refer to the prequalification process, page 8 of the Section II document and evaluation criteria in the Section IV documentThe ITB will be organized straightaway after the results of the prequalification process will be shared with suppliers. Suppliers with the best value for money offers for the provision of the items accepted by UNOPS/StopTB-GDF will be awarded a three-year long-term agreements (LTA) for a specific list of products. UNOPS/StopTB-GDF will issue PO to supplier(s) only after the signature of the LTA(s).Prequalified suppliers that did not get any award during the ITB process can be contacted by UNOPS/StopTB-GDF during the 3 years validity of the prequalification for specific procurement to respond to different situation such as the incapacity of the LTA holder to supply the goods or to respond to an increased demand.2. Annex 3 states at paragraph 5: The manufacturer/distributors shall provide the copies of certificates of sterilization for the most recently manufactured batch. Does this mean that for each sterile items, a copy of the CoS of the most recent batch has to be submitted? Is this a mandatory exercise?Answer: The provision of the copies of certificates of sterilization for the most recently manufactured batch is applicable only after the signature of the LTA with supplier and part of the contract management. For the prequalification process, suppliers are only requested to provide the document listed in the checklist section of the e-sourcing platform.3. Annex 3 states at paragraph 7: The supplier/manufacturer shall provide the copies of certificates for protective clothing: i. ISO 13688: 2013 (Protective clothing -General requirements) ii. ISO 16900-7:2015 - Respiratory protective devices -- Methods of test and test equipment -- Part 7: Practical performance test method. Does this mean that for each PPE item, certificates have to be submitted proving compliancy with these ISO norms?Answer: The provision of the copies of certificates for protective clothing for the most recently manufactured batch is applicable only after the signature of the LTA with supplier and is part of the contract management. For the prequalification process, suppliers are only requested to provide the document listed in the checklist section of the e-sourcing platform.

Edited on: 01-May-2019 16:44

Edited by: webservice@unops.org

New clarification added: It is stated that the offer validity is 120 days after submission deadline. However, how long does the bidder have the keep the quoted prices valid? (i.e. 31.12.2019)Answer: The validity of 120 days required during the Pre-qualification process is for the product that the applicant offers for Lot 1 and Lot 2.The pre-qualification process does not require financial offer.As a subsequent step of this pre-qualification process, a follow-up Invitation to Bid (ITB) shall be conducted with the Shortlisted Applicants during which the prequalified suppliers will be invited to provide a price and a delivery lead time for each product of the list of accepted laboratory. ITB process will be awarded a three-year long-term agreement (LTA) and with good performance of the Contractor, the option to renew the LTA/s for two additional periods of one (1) year each under the same terms and conditions for a maximum of five (5) years.

Edited on: 01-May-2019 16:41

Edited by: webservice@unops.org

New clarification added: Please clarify for which countries, installation, training & maintenance should be quoted for, as this may differ from country to country, especially in developing countries. it concerns following items from Lot 1 and 2:106490106489ITEM 17.10ITEM 17.20 ITEM 17.30ITEM 17.40 ITEM 17.50Lot 2NEW ITEM 15.7NEW ITEM 15.9NEW ITEM 15.16NEW ITEM 15.17NEW ITEM 15.24NEW ITEM 15.25NEW ITEM 17.1NEW ITEM 17.11NEW ITEM 17.21NEW ITEM 17.31NEW ITEM 17.41NEW ITEM 17.51NEW ITEM 17.60NEW ITEM 17.61NEW ITEM 17.70NEW ITEM 17.71NEW ITEM 17.80NEW ITEM 17.81Answer: The price for installation, training and maintenance for autoclaves and biosafety cabinets for Lot 1 and Lot 2 should be at the global level, for all low- and middle-income countries (according to World Bank 2019 fiscal year classification) would have access to the offered prices.Please see Documents Section of the eSourcing that contains the list of countries to which GDF have made deliveries of TB diagnostics products, in the period up to December 2018.

Edited on: 01-May-2019 16:40

Edited by: webservice@unops.org

New clarification added: Please advise if partial bids within a lot are accepted or all items within a lot must be offered.Answer: Lot 1: Applicants must submit a Bid for ALL the products of the Lot 1. The total products quantity in Lot 1 is 407. Failure to provide a Bid for a product of Lot 1 may lead to the rejection of the application for Lot 1.Lot 2: Applicants are STRONGLY requested to submit a Bid for all the products of the Lot 2. The Applicants can offer at least ONE product for Lot 2.

Edited on: 01-May-2019 16:38

Edited by: webservice@unops.org

New clarification added: Dear Sir/Madam,Referencing subject RFQ, specifically on the products list, please advise on below, - Is a supplier allowed to express interest on selected items on each Lot?? Is there a minimum Number?Answer: Lot 1: Applicants must submit a Bid for ALL the products of the Lot 1. The total products quantity in Lot 1 is 407. Failure to provide a Bid for a product of Lot 1 may lead to the rejection of the application for Lot 1.Lot 2: Applicants are STRONGLY requested to submit a Bid for all the products of the Lot 2. The Applicants can offer at least ONE product for Lot 2. - If above inquiry is YES, does a supplier need to meet the Financial requirements of Annual turnover of USD 2M?Answer: Yes. The minimum average annual turnover of the applicant for the last 3 years shall be at least USD 2 million. Below USD 2 million, the applicant will be rejected.

Edited on: 01-May-2019 16:37

Edited by: webservice@unops.org

New amendment added #1: To add the list of countries of TB diagnostics by UNOPS Stop TB-GDF as an attachement under the documents Section of the tender as requested during tender clarification process.

Edited on: 30-Apr-2019 10:49

Edited by: webservice@unops.org

New clarification added: Please see the clarification.

Edited on: 29-Apr-2019 15:17

Edited by: webservice@unops.org

New clarification added: Please see the clarification.

Edited on: 29-Apr-2019 15:15

Edited by: webservice@unops.org

New clarification added: Please see the clarification.

Edited on: 29-Apr-2019 15:13

Edited by: webservice@unops.org

New clarification added: Please see the clarification.

Edited on: 29-Apr-2019 15:10

Edited by: webservice@unops.org

New clarification added: Question: Is a supplier allowed to express interest on selected items on each Lot? Is there a minimum Number?Answer: Lot 1: Applicants must submit a Bid for ALL the products of the Lot 1. The total products quantity in Lot 1 is 407. Failure to provide a Bid for a product of Lot 1 may lead to the rejection of the application for Lot 1.Lot 2: Applicants are STRONGLY requested to submit a Bid for all the products of the Lot 2. The Applicants can offer at least ONE product for Lot 2.Question: If above inquiry is YES, does a supplier need to meet the Financial requirements of Annual turnover of USD 2M?Answer: Yes. The minimum average annual turnover of the applicant for the last 3 years shall be at least USD 2 million. Below USD 2 million, the applicant will be rejected.Question: Please advise if partial bids within a lot are accepted or all items within a lot must be offered.Answer: Lot 1: Applicants must submit a Bid for ALL the products of the Lot 1. The total products quantity in Lot 1 is 407. Failure to provide a Bid for a product of Lot 1 may lead to the rejection of the application for Lot 1.Lot 2: Applicants are STRONGLY requested to submit a Bid for all the products of the Lot 2. The Applicants can offer at least ONE product for Lot 2.Question: Please clarify for which countries, installation, training & maintenance should be quoted for, as this may differ from country to country, especially in developing countries.Answer: The price for installation, training and maintenance for autoclaves and biosafety cabinets for Lot 1 and Lot 2 should be at the global level, for all low- and middle-income countries (according to World Bank 2019 fiscal year classification) would have access to the offered prices.Please see Documents Section of the eSourcing that contains the list of countries to which GDF have made deliveries of TB diagnostics products, in the period up to December 2018.Question: It is stated that the offer validity is 120 days after submission deadline. However, how long does the bidder have the keep the quoted prices valid? (i.e. 31.12.2019)Answer: The validity of 120 days required during the Pre-qualification process is for the product that the applicant offers for Lot 1 and Lot 2.The pre-qualification process does not require financial offer.As a subsequent step of this pre-qualification process, a follow-up Invitation to Bid (ITB) shall be conducted with the Shortlisted Applicants during which the prequalified suppliers will be invited to provide a price and a delivery lead time for each product of the list of accepted laboratory. ITB process will be awarded a three-year long-term agreement (LTA) and with good performance of the Contractor, the option to renew the LTA/s for two additional periods of one (1) year each under the same terms and conditions for a maximum of five (5) years.

Edited on: 29-Apr-2019 15:07

Edited by: webservice@unops.org