Detail Package

Procurement of IHK Set

Project
SIHREN Parallel Financing
Project Description
Strengthening Indonesia's Healthcare Referral Network (SIHREN IsDB): a parallel financing IsDB for the referral hospital component.
Package Name
Procurement of IHK Set
Loan No.
IDN1070
Activity Reference No.
KS.01.02/A.VI/6167/2024
Market Approach
International Open
Procurement Method
Request for Bids (RFB) - 1 Stage 2 Envelope (Rated Criteria)
Estimated Total Cost
€95,858,767.65
Currency
Euro
Stages
Financial Evaluation
Bid Submission Deadline
14 Oct 2025

Package Lot

Name Of Lots Units Amount
Lot 1: Procurement of Immunohistochemistry Set (West) 184 €35,276,026.49
Lot 2: Procurement of Immunohistochemistry Set (Central) 97 €18,596,600.92
Lot 3: Procurement of Immunohistochemistry Set (East - Maluku & Sulawesi) 106 €20,322,058.74
Lot 4: Procurement of Immunohistochemistry Set (East - Bali, Nusa Tenggara & Papua) 113 €21,664,081.49

Documentation

Published Date Document Name
2024-10-11 Specific Procurement Notice - Procurement of IHK Set
2024-10-11 Bidding Document - Procurement of IHK Set
2024-10-11 Technical Specification - Procurement of IHK Set
2024-12-03 1st Amendments to Bidding Document - Procurement of IHK Set
2024-12-05 Minutes of Prebid Meeting - Procurement of IHK Set
2024-12-18 2nd Amendment to Bidding Document - Procurement of IHK Set
2024-12-21 3rd Amendment to Bidding Document - Procurement of IHK Set
2024-12-21 Technical Specification (Updated file as per the issued 3rd Amendment to Bidding Document) - Procurement of IHK Set

Responses to Clarification of Bidding Document (Procurement of IHK Set)

No. Date of Received Question Responses Part (RFB) Cluster Sub Cluster
1 2024-10-18 3. As proof of compliance to the specific experience requirements, the bid document requires bidders to submit copies of relevant pages of signed contracts AND corresponding completion certificates.
We would like to respectfully request the procurement committee to allow bidders to submit copies of relevant pages of signed contracts which are confirmed to be substituted by PO/DO OR corresponding
completion certificates (such as installation reports from the bidder to the end- customer) as proof of compliance to the specific experience requirements.
Both the copy of the contract and the completion report are verifiable documents, and we believe each of the documents is already sufficient to
prove the bidder’s experience.
Please refer to the respective response on the question #ITB 32.1.
The Bidder shall demonstrate that it has successfully and substantially completed of similar Goods and Related Services (installation). For a joint venture, this requirement may be met by all members combined. In case bidder wants to submit PO/DO instead of contract page, the bidder still need to demontrate the experience not only delivery part, but also shows experience on the related services (installation)
Bidding Procedure Procurement Regulations Rated Criteria (Scoring Methodology)
2 2024-10-18 4. Based on ITB 32.1, Qualification Criteria (b), we understand that the procurement committee requires bidders to:
1. furnish detailed inFormsation regarding contracts completed, including contract role (prime supplier, subcontractor, partner in Joint Venture)
2. submit documentary evidence as proof of compliance to such experience requirement and that purchase order (PO) / delivery order (DO) are acceptable documents if contracts cannot be provided due to confidentiality/non-disclosure clauses
We would like to clarify the required documents in the following scenario:
1. A manufacturer called “company A” supplies IHK Set equipment. Company A plans to be the Bidder in the current Request for Bids.
2. “Company A” appointed a distributor called “company B” to act as the prime supplier to serve end-customers in Indonesia
3. “Company A” has PO/DOs to “Company B” who acted as the prime supplier
If Company A wants to bid in the current Request for Bids, can it submit DO/POs to Company B to prove experience capacity?
Please refer to the respective response on the question #2. Bidding Procedure Procurement Regulations Eligible Bidders (including joint venture)
3 2024-10-18 2. According to Qualification Criteria (e) on cybersecurity, the bidder should have experience in managing cyber security, practice and track record, including relevant Cyber security accreditation such as ISO 27000 (ISO27001) or equivalent.
We kindly request for your confirmation that a statement letter from us as the bidder indicating that we adhere to the cybersecurity policies and mitigation control and processes set by our global office, who is accredited with ISO 27001, suffices as an equivalent to the Qualification Requirements. We will attach the policy and the ISO 27001 accreditation from our global office, and the MDS2 Forms as per tender requirement.
Thank you for the question. If the manufacturer is not the bidder or part of the JV, relevant documentation is to be provided (by the Bidder) that clearly demonstrates the bidder's experience in managing cyber security, practice and track record, including relevant Cyber security accreditation such as ISO 27000 (ISO 27001) or equivalent, and commits to ensure these cybersecurity requirements for all devices part of the bid. The bidder is also requested to provide relevant equipment cybersecurity mitigation measures via their MDS2 Forms in the bid. Bidding Procedure Evaluation Process Specific Experience
4 2024-10-18 We are writing to seek additional clarification on the following questions, pursuant to Instructions to Bidder of the bidding documents.
Average Annual Turn Over (AATO) Page 54 Section III - Evaluation and Qualification Criteria
On page 54 of the RFB, the required minimum average annual turn over is expressed in Euros (e.g. 17.6 million Euro for Lot 1). In cases where the Bidder's financial statement is in another currency (e.g. Indonesian Rupiah), can you please confirm what will be the conversion rate used for evaluation purposes to confirm if the bidder meets the financial capacity requirement?
Will it also be the transaction rate of the Bank Indonesia as per ITB 36.1?
Thank you for your question. For currency conversion to meet the Qualification Requirementss of AATO experience, you may refer to the Transaction Selling Rate of Bank Indonesia available at https://www.bi.go.id/en/statistik/inFormsasi- kurs/transaksibi/default.aspx. The exchange rate should be based on the date of the bid submission deadline. Please refer to the Bidding Document (Section II - Bid Data Sheet, ITB 36.1, Page 51). Bidding Procedure Evaluation Process Evaluation Criteria
5 2024-10-22 Dear Procurement Committee 4,
We are writing to share recommendations as interested bidders to the recently published Request for Bids for Immunohistochemistry (IHK) Set financed by the Islamic Development Bank. We seek to recommend ways to broaden competition for the planned IHK tender and to ensure the effectiveness of the procurement process, given that most pre-analyzer instruments are already available in the market, thereby improving value for money (VfM) to achieve the objectives of Indonesia’s Health TransFormsation Agenda. Therefore, We would like to request the Ministry of Health to separate the planned procurement packages for IHK Sets into individual lots for the pre-analyzers (microtome, hot plate, cold plate, tissue floating bath and reagent refrigerator) and the analyzer (automated immunohistochemistry stainer) equipment.
Please find the justification by the official letter attached.
Thank you for your consideration and we look forward to receiving your feedback.
Separating the analyzer and pre-analyzers will permit the government to obtain better prices for the benefit of the project and the people of Indonesia, also to maximize utilization of existing pre-analyzer instrument in the market, and is consistent with the IsDB’s core procurement principles of value for money and economy, according to Guidelines for the Procurement of Goods, Works, and Related Services under ISDB Project Financing Chapter 1, paragraph 1.2.1. The same guidelines by the ISDB Chapter 1, paragraph 1.2.1 repeatedly emphasize the importance of “ensuring maximum competition”, “broadest possible competition” in the process and content of its tenders in line with these principles.
Encourage Competition: In the current planned structure, only 1 supplier globally can completely supply the whole IHK set. Having separate procurement for the IHK analyzer will allow the broadest possible competition.
Combining the procurement of pre-analyzers and analyzer in one bid package poses risks for the Ministry of Health to receive a combination of satisfactory and unsatisfactory pre-analyzers and analyzer. On the contrary, separating the pre-analyzer and the analyzer will encourage submission of high-quality and most advantageous bids from suppliers in the respective areas of expertise.
Standard analyzers available in the market are compatible with most pre-
analyzer equipment and solutions and will not cause compatibility issues.
Many thanks for this feedback. MoH will retain the current specification.
Bidders are encouraged to split all components into individual equipment and float to bidders for better control and include various manufacturers and bidders.
Other Unrelated Questions Unrelated Questions
6 2024-10-22 Technical Part Page 67 Section IV - Bidding Formss
On page 67 of the RFB, it specifies that the bidder shall furnish a list giving full particulars including available sources and current prices of spare parts.
However the technical specification excel spreadsheet does not contain a tab to indicate the detailed list of spare parts. Tabs are only available for accessories and consumables which are different from spare parts. The spare parts mentioned in the recurrent cost table is also not a full list as we understand this is only for spare parts that will be replaced.
Can you please clarify if bidders are required to provide a full list of spare parts and current prices? If yes, we will appreciate your advice on where the full list and prices can be indicated.
Thank you for your question. The list of spare parts required for the 10-year period of operation, along with their costs, should be included in the "Recurrent Cost for Operation and Maintenance Cost Table." You can find this table in the bidding documents. Bidding Procedure Evaluation Process Technical Evaluation
7 2024-10-29 Technical Specification Excel Spreadsheet, row 181 on Flat lid with 2 ring sets for SAPXX:
Row 181 (Flat lid with 2 ring sets for SAPXX) We would like to request this specification to be removed or made optional (orange criteria) instead of mandatory (green criteria) since the specification is irrelevant with a tissue floating bath - this specification is for hotplates that are used in general lab needs and cannot be used for anatomical
pathology labs
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications. Supply Requirements Evaluation Process Qualification Requirements
8 2024-10-29 Technical Specification Excel Spreadsheet, row 178 on Raised shelf:
Row 178 (Raised Shelf)
We would like to request this specification to be removed or made optional (orange criteria) instead of mandatory (green criteria) since the specification is irrelevant with a tissue floating bath - this specification is for hotplates that are used in general lab needs and cannot be used for anatomical pathology labs
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications. Supply Requirements Evaluation Process Qualification Requirements
9 2024-10-29 Technical Specification Excel Spreadsheet, row 160 on Embedding Console System:
Row 160 (Embedding Console System)
We would like to request this specification be changed to preferred (orange criteria) instead of mandatory (green criteria) since the function is available on other instruments. The embedding module (liquid parafin chamber & dispenser) and cold plate module are not related to the microtome function
Many thanks for this feedback. As this specification is mandatory, the bidder can choose to comply or not. MoH will retain the current specification.
This provides an additional feature to remain as a neutral tech spec.
Supply Requirements Evaluation Process Qualification Requirements
10 2024-10-29 Technical Specification Excel Spreadsheet, row 168 on Boss head clamp:
Row 168 (Boss head clamp)
We would like to request this specification to be removed or made optional (orange criteria) instead of mandatory (green criteria) since the specification on the general lab hotplate does not match with the tissue floating bath specification needed for a histology lab
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications. Supply Requirements Evaluation Process Qualification Requirements
11 2024-10-29 Technical Specification Excel Spreadsheet, row 186 on Rack for Tubes:
Row 183 (Rack for Tubes)
We would like to request this specification to be removed or made optional (orange criteria) instead of mandatory (green criteria) since the specification is irrelevant with a tissue floating bath - this specification is for hotplates that are used in general lab needs and cannot be used for anatomical pathology labs
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications. Supply Requirements Evaluation Process Qualification Requirements
12 2024-10-29 Technical Specification Excel Spreadsheet, row 179 on Transparent polycarbonate lid for SAPXX:
Row 179 (Transparent polycarbonate lid for SAPXX)
We would like to request this specification to be removed or made optional (orange criteria) instead of mandatory (green criteria) since the specification is irrelevant with a tissue floating bath - this specification is for hotplates that are used in general lab needs and cannot be used for anatomical pathology labs
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications. Supply Requirements Evaluation Process Qualification Requirements
13 2024-10-29 Technical Specification Excel Spreadsheet, row 180 on Stainless steel sloping lid for SAPXX:
Row 180 (Stainless steel sloping lid for SAPXX)
We would like to request this specification to be removed or made optional (orange criteria) instead of mandatory (green criteria) since the specification is irrelevant with a tissue floating bath - this specification is for hotplates that are used in general lab needs and cannot be used for anatomical pathology labs
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications. Supply Requirements Evaluation Process Qualification Requirements
14 2024-10-29 Technical Specification Excel Spreadsheet, row 184 on petri Dish Rack:
Row 184 (Stainless Steel Petri Dish Rack)
We would like to request this specification to be removed or made optional (orange criteria) instead of mandatory (green criteria) since the specification is irrelevant with a tissue floating bath - this specification is for hotplates that are used in general lab needs and cannot be used for anatomical pathology labs
Thank you for the opportunity to submit our clarifications and we appreciate the urgent attention to the mandatory specifications mentioned above as these will preclude at least 3 major equipment suppliers from participating in the procurement process.
For easier reference, we have also provided a summary of the proposed amendments below (see annex).
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications. Other Unrelated Questions Unrelated Questions
15 2024-10-29 Technical Specification Excel Spreadsheet, row 83 on Bath Reservoir Material:
Row 83 (Bath Reservoir Material)
We would like to request to include Pyrex as an option for this material as the bath reservoir material varies among brands. Pyrex perFormss equally to stainless steel bath reservoir material. In fact, maintenance and cleaning may be easier with Pyrex, as this device can be readily assembled and disassembled. The cleaning after use is important due to many tissue samples floated on the water and potential cross
contamination.
Many thanks for this feedback. As this specification is mandatory, the bidder can choose to comply or not. MoH will retain the current specification.
Bidder to specify the material for bath reservoir. Pyrex is a proprietary trade mark. Material ensure a neutral tech specs e.g. Borosilicate glass
Bidding Procedure Evaluation Process Qualification Requirements
16 2024-10-29 Technical Specification Excel Spreadsheet, row 182 on Base Tray for SAPXX:
Row 182 (Base Tray for SAPXX)
We would like to request this specification to be removed or made optional (orange criteria) instead of mandatory (green criteria) since the specification is irrelevant with a tissue floating bath - this specification is for hotplates that are used in general lab needs and cannot be used for anatomical pathology labs
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications. Supply Requirements Evaluation Process Qualification Requirements
17 2024-10-29 Technical Specification Excel Spreadsheet, row 164 on Optical Accessories:
Row 164 (Optical Accessories)
We would like to request this specification be changed to preferred (orange criteria) instead of mandatory (green criteria) since the optical accessories are not relevant to the microtome's main function as a tissue slicer.
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications. Supply Requirements Evaluation Process Qualification Requirements
18 2024-10-29 Technical Specification Excel Spreadsheet, row 175 on Thermal Interface Materials:
Row 175 (Thermal Interface Materials)
We would like to request this specification to be removed or made optional (orange criteria) instead of mandatory (green criteria) since the thermal interface materials are already mentioned on the technical
specification part
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications. Supply Requirements Evaluation Process Qualification Requirements
19 2024-10-29 Technical Specification Excel Spreadsheet, row 169 on Holding rod:
Row 169 (Holding rod)
We would like to request this specification to be removed or made optional (orange criteria) instead of mandatory (green criteria) since the specification on the general lab hotplate does not match with the
tissue floating bath specification needed for a histology lab
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications. Supply Requirements Evaluation Process Qualification Requirements
20 2024-10-29 Technical Specification Excel Spreadsheet, row 84 on Temperature Range:
Row 84 (Temperature Range)
We would like to request narrowing down the temperature range to
+5°C to 50°C since tissue samples will degrade if temperatures are allowed to reach 100°C
Many thanks for this feedback. As this specification is mandatory, the bidder can choose to comply or not. MoH will retain the current specification.
Bidder's suggestion may be restrictive and suggested minimum lower temperature range shall exclude other proposed models/ devices
i.e. limiting better higher temperature
controlling devices.
Bidding Procedure Evaluation Process Qualification Requirements
21 2024-10-29 Technical Specification Excel Spreadsheet, row 167 on PTFE (polyetrafluoroethylene)-
coated magnetic stir bar:
Row 167 (PTFE (polytetrafluoroethylene)-coated magnetic stir bar) We would like to request this specification to be removed or made optional (orange criteria) instead of mandatory (green criteria) since the specification is for the general lab hotplate with stirrer, thehistology lab should be a tissue floating bath
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications. Supply Requirements Evaluation Process Qualification Requirements
22 2024-10-29 We respectfully submit this correspondence to request clarification on several points related to the Immunohistochemistry Set Specification, in accordance with Instructions to Bidders (ITB 7.1) of the bidding documents.
Technical Specification Excel Spreadsheet, row 59 on Specimen Cooling Option:
Row 59 (Specimen Cooling Option)
We would like to request to remove this specification because only less than 3 vendors can fulfill this requirement.
Many thanks for this feedback. As this specification is rated criteria, the bidder can choose to comply or not. MoH will retain the current specification.
Cooling the specimen significantly enhances cutting quality, consistency, and ease-of- handling, making it a highly practical feature for most microtome users; but not mandatory. Recommended to keep as preferred as it does have practical advantage. This provides an additional feature to remain as a neutral tech spec.
Bidding Procedure Evaluation Process Technical Evaluation
23 2024-10-29 Technical Specification Excel Spreadsheet, row 174 on External Temperature Sensors:
Row 174 (External Temperature Sensors)
We would like to request this specification to be preferred (orange criteria) instead of mandatory (green criteria) since the cold plate will focus on maintaining the cold plate or block temperature
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications. Supply Requirements Evaluation Process Qualification Requirements
24 2024-10-30 ITB 4.8 (b) - page 11 and Bidder Eligibility, under Section V Eligible Countries
- page 87
May we kindly ask for the MOH's advice on where and how we can access official copies of the Boycott Regulations of the Organization of the Islamic Cooperation, the League of Arab States and the African Union, as referenced in accordance with Para 1.8.1 of the Procurement Policy of the Guidelines for Procurement of Goods, Works and Related Services under
Islamic Development Bank Project Financing, (April 2019 edition)? Our firm is eager to conduct a full review and strictly comply with the requirements indicated in the Boycott Regulations.
The IsDB is governed by the policies and principles agreed upon by its member countries, many of which are members of the Organization of Islamic Cooperation (OIC). Consequently, the IsDB Boycott regulation is a mandatory inclusion in our Procurement Guidelines and all related bidding documents.
Procurement under the project shall be carried out in accordance with IsDB’s Procurement Policy and Procedures through provisions contained in the IsDB’s
(i) Guidelines for the Procurement of Goods, Works and Related Services under IsDB Project Financing (April 2019 edition, revised in February 2023) and (ii) Guidelines for the Procurement of Consultants Services under IsDB Project Financing (April 2019 edition, revised in February 2023). Core procurement principles of the IsDB shall be respected throughout all procurement transactions.
According to:
• Paragraph 1.8.1 of the Procurement Guidelines, it is a fundamental policy of IsDB that the Request for Bids (RFB) shall unequivocally stipulate that the Goods, Works and/or Related Services provided by the Contractor, and its associates and sub-contractors, shall be in strict compliance with the Boycott Regulations of the Organization of the Islamic Cooperation, the League of Arab States, and the African Union (Boycott Regulations). The Beneficiary shall advise prospective Bidders that Bids will only be considered from Firms that are not subject to these Boycott Regulations. The Bidder shall provide a letter of oath to that effect.
• Paragraph 1.8.3 The eligibility of a Firm will be determined during the Evaluation Process. In cases where Firms withhold inFormsation to evade disqualification on account of the eligibility requirement, the Beneficiary will have the right to cancel the contract at any time and also to penalize such Firms and claim compensation for losses incurred by the Beneficiary and/or IsDB as a consequence thereof. IsDB reserves the right not to honor any contract if the Contractor involved is found to be ineligible based on the eligibility requirement stated herein.
• Letter of Bid – Technical Part, paragraph (i) Suspension and Debarment. The bidder shall confirmed that they, along with any of their subcontractors, suppliers, consultants, manufacturers, or service providers for any part of the contract, are not subject to, and not controlled by any entity or individual that is subject to, a temporary suspension or a debarment imposed by the IsDB Group or a debarment imposed by the IsDB Group in accordance with the Agreement for Mutual Enforcement of Debarment Decisions between the IsDBI and other development banks. Further, the bidder is not ineligible under the Purchaser’s country laws or official regulations or by an act of compliance with a decision of the Organization of the Islamic Cooperation, the League of Arab States and the African Union.
• Resolution 1/49-IBO on Islamic Office for the Boycott of Israel, point #1, Recalls the Jakarta Declaration on Palestine and Al-Quds Ash-Sharif, adopted during the Fifth Extraordinary Islamic Summit on Palestine and Al-Quds Ash- Sharif on 7 March 2016, containing commitments to pursue concrete actions to be collectively taken towards the realization of the inalienable rights of the Palestine People, including calls upon the international community to support the boycott of products produced in or by the illegal Israeli settlement
As an organization committed to ethical standards and complying with international regulations, the IsDB includes specific clauses in its bidding documents to align with these principles and legal obligations. The Boycott regulation is one such clause, reflecting our commitment to the policies and principles established by our member countries and governing bodies.
The inclusion of the Boycott regulation is a standard practice in IsDB-financed projects and is not intended to disadvantage or discriminate against any potential bidder. Instead, it ensures that all participants in IsDB-funded projects comply with the established regulations that govern the procurement process. We understand that this may present certain challenges for bidders, but it is important to maintain the integrity and fairness of the procurement process by adhering to these regulations. Unfortunately, we are unable to accommodate your request to remove the IsDB Boycott regulation from the bidding document.
Bidding Procedure Procurement Regulations Eligible Bidders (including joint venture)
25 2024-10-30 2. Can you kindly confirm if our understanding is correct that the price to be quoted for Price Schedule: Goods should include the main equipment and all accessories, however it should not contain the items listed in the related services (warranty, consumables, installation, training, etc.)? Installation of the equipment, testing, commissioning, training and other services are to be quoted in table of related services. Please refers to Bidding Document Section VII: Schedule of Requirements. Bidding Procedure Evaluation Process Financial Evaluation (including related services)
26 2024-10-30 #16 of (3.) Technical Specifications under Section VII - Schedule of Requirements - page 121
According to the second paragraph of #16. IN-PERSON TRAINING under Technical Specifications of Section VII (page 121), Refresher Training Courses should be offered in virtual modality on a quarterly basis at the least.
We would like to confirm that the Bidder will be allowed to offer the Purchaser with virtual access to pre-recorded training courses that can be accessed any time without need for human intervention. The refresher courses will be delivered through a proprietary Learning Management System that will allow multiple locations to participate at a time, and issue certificates after completing the course.
Many thanks for this feedback. MoH will retain the current requirement. Please refer to RFB Section VII- Schedule of Requirements, 3. Technical Specifications, 16. In Person Training, Page 121. Supply Requirements Evaluation Process Qualification Requirements
27 2024-10-30 2. Should the proposed consumables tab be filled up based on 1 IHK set? Or should bidders multiply the amount to match all equipment in the lot? Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications. Supply Requirements Evaluation Process Qualification Requirements
28 2024-10-30 3. Please kindly clarify if the consumables should be for 100 typical patient procedures or for 365 days of operation as indicated in the technical specifications Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications. Supply Requirements Evaluation Process Qualification Requirements
29 2024-10-30 ITB 20.3
We would like to request for your clarification that the bidder is allowed to have more than one authorized representative to sign the official bid documents. In such case, each authorized representative will be provided with their respective Special Power of Attorney certificate.
Thank you for your question. Yes, it is acceptable for the representative who signs the bidding documents to be different from the representative who attends the bid opening meeting. However, the representatives who attend must be authorized to act on behalf of the bidder, and a signed power of attorney letter should be provided to confirm their authority. Other Unrelated Questions Unrelated Questions
30 2024-10-30 2. Our concern is that costs will be double counted if items are already included in bid price and then it will still be treated as additional costs in the recurrent costs table. As such, can we put 0 costs for user training, consumables, and spare parts for years 1-5 since this is already included in the bid price? Draft Response:
According to Section VII - Schedule of Requirements and ITB 11.1 of the RFB, all costs must be clearly itemized and consistent across the bid price and the recurrent costs table to ensure transparency and avoid double counting. If the costs for user training, consumables, and spare parts for years 1-5 are already included in the bid price, bidders may indicate these items as “0” in the recurrent costs table. However, a clear note must accompany this declaration to explain that these costs are already accounted for in the bid price.
Bidding Procedure Evaluation Process Evaluation Criteria
31 2024-10-30 #16 of (3.) Technical Specifications under Section VII - Schedule of Requirements - page 121
According to the second paragraph of #16. IN-PERSON TRAINING under Technical Specifications of Section VII (page 121), Medical Doctors (cardiologists, cardiac physiologists, radiologists, etc.) and non-medical doctors (radiographers, etc.) will be part of the training sessions.
IHC is typically perFormsed by specialized laboratory personnel like pathologists and laboratory technicians, with interpreted IHC results forwarded to Medical Doctors like cardiologists to provide treatment plans. On the other hand, Radiographers do not operate an IHC in any hospitals.
In order to develop the best training module, we would like to ask for the MOH's confirmation that both the in-person training and referesher courses are targeted for laboratory personnel only who will operate the IHK Set - i.e., histotechnologists, pathologists, laboratory technicians, clinical laboratory scientists.
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications..
The in-person training and referesher courses should be arranged to the targeted for laboratory personnel who will operate and maintenance the IHK Set - i.e., histotechnologists, pathologists, laboratory technicians, clinical laboratory scientists, and biomedical technicians/engineers.
Supply Requirements Evaluation Process Qualification Requirements
32 2024-10-30 Price Schedule: Goods Manufactured Outside Member's Country, to be imported Page 79
We would like to clarify how bidders should fill the Price Schedule for Goods (page 79):
1. Can you kindly advise if bidders should fill the Price Schedule for Goods table by providing one row per final destination (e.g. 184 hospitals = 184 rows) or can bidders just put one row for the whole lot (184 hospitals = 1 row) since the bid will be evaluated as a whole lot?
Draft Response:
As stated in ITB 14.1 and Section VII - Schedule of Requirements of the RFB, the Price Schedule for Goods should align with the specific requirements outlined in the bidding document. For this project, bidders may consolidate the total cost for all destinations into a single row if the evaluation is conducted on a whole-lot basis. However, if the bidding document specifies that pricing should be broken down by destination, such as for individual hospitals, bidders should provide one row per destination.
Bidding Procedure Evaluation Process Evaluation Criteria
33 2024-10-30 Specific Experience
(b) under Section III - Evaluation and Qualification Criteria Page 54-55
We understand that bidders shall provide details on past contract experience as per (b) Specific Experience under Section III - Evaluation and Qualification Criteria. One of the inFormsation required is the date of contract completion.
We would like to clarify if contract completion in this context means either the delivery date or installation date of the equipment?
In order to demonstrate it meets the experience requirement at minimum, the Bidder shall furnish detailed inFormsation regarding contracts completed: the purchaser’s name and address, country, name and object of the contract, scope of services, date of contract completion, equipment supplied, contract amount, contract role (prime supplier, subcontractor, partner in Joint Venture) and percent of the contract value undertaken by subcontract. As a proof of the compliance, the Bidder shall provide copies of relevant pages of signed contracts and corresponding completion certificates. If any such contract includes a confidentiality/non-disclosure clause and the Bidder does not agree to provide a copy (to be confirmed by a Formsal letter), such bidder must provide other documents acceptable for the Purchaser (such as copy of purchase order/delivery order). Bidding Procedure Evaluation Process Specific Experience
34 2024-10-30 PerFormsance Security GCC 18 Page 134
We would like to seek your confirmation if the attached PerFormsance Security (Bank Guarantee) template is acceptable to the MoH?
As per GCC 18.3, we understand that the perFormsance security can be in the Formsat stipulated in the Bid Document, or in another Formsat acceptable to the Purchaser. While the PerFormsance Security is required only for the successful bidder, the confirmation from MOH will ensure that our firm may be able to provide such document within 28 days of potential notification of award.
Thank you for the opportunity to submit our clarifications and we look forward to receiving your feedback
Thank you for your question. Bidder may refer to the perFormsance security template in RFB document. Please refer to RFB Document ( Section IX - Special Conditions of Contract, PerFormsance Security, Page 175). Contract Contract Management Warranty
35 2024-10-30 Price and Completion Schedule - Related Services Page 85
We would like to clarify how bidders should fill the Price Schedule for Related Services (page 85):
2. Kindly please clarify if the proprietary consumables (5 years) mentioned in the related services table is the same as the start up consumables listed on row 199-208 in the technical specifications sheet?
As outlined in Section VII - Schedule of Requirements and ITB 14.1 of the RFB, the proprietary consumables listed in the Price and Completion Schedule for Related Services (page 85) are intended to cover the ongoing needs over the contract duration. Meanwhile, the startup consumables detailed in rows 199-208 of the technical specifications sheet refer to items required during initial deployment or commissioning. If the proprietary consumables for five years are meant to include startup consumables, it must be explicitly stated to avoid overlap or double counting. Supply Requirements Evaluation Process Financial Evaluation (including related services)
36 2024-10-30 Price and Completion Schedule - Related Services Page 85
We would like to clarify how bidders should fill the Price Schedule for Related Services (page 85):
1. We would like to confirm if bidders can quote one row per service and put the quoted price for all units in one lot (e.g. one row for user training indicating price for 55 units (lot 1), and similarly one row for warranty indicating price for 55 units over 5 years)?
Draft Response:
As stated in ITB 14.1 and Section VII - Schedule of Requirements of the RFB, the Price Schedule for Related Services should be completed in accordance with the bidding document’s instructions. If the evaluation is based on a lot, bidders may consolidate the costs for related services into a single row for each service type, such as user training or warranty, and include the total price for all units in the lot. This approach ensures clarity and aligns with lot-based evaluation criteria.
Contract Contract Management Contract
37 2024-10-30 Recurrent Costs for Operation and Maintenance Page 86
In the table for recurrent costs for operation and maintenance (page 86), we noted that recurrent costs for year 1-5 are already included in the Bid Price.
In the list of related services however, the bidder is also requested to quote a comprehensive service contract for year 6-10. Can we confirm that the quotation for the comprehensive service contract for year 6-10 should also be included in the bid price?
The bidder is requested to quote the recurrent costs for operation and maintenance for mandatory warranty period (years 1-5), which shall be included in the bid prices, while also quoting comprehensive service and maintenance prices for year 6 up to 10 for which the bidder will commit to for such period.
This recurrent costs will be used for the purpose of financial evaluation.
Bidding Procedure Evaluation Process Financial Evaluation (including related services)
38 2024-10-30 Specific Experience
(b) under Section III - Evaluation and Qualification Criteria Page 54-55
According to the (b) Specific Experience under Section III - Evaluation and Qualification Criteria, bidder shall demonstrate that it has successfully and substantially completed contracts of similar Goods and Related Services (installation) per Lot.
Given that the IHK Set has several components, can you confirm that it is sufficient for the bidder to provide details on completed contracts (installation) for the main IHK analyzer equipment (automatic immunohistochemistry stainer) to demonstrate its experience and meet the eligibility requirements? The main IHK analyzer equipment is the most sophisticated equipment and represents the biggest part of the cost.
Thank you for your question. We have revise the requirement as follows:
Based on the RFB, the bidder must be able to demonstrate experience in supplying and installing Microtomes annually in any one year and Automatic Immunohistochemistry Stainers annually in any one year within the last seven
(7) years. As the Microtomes and Automatic Immunohistochemistry Stainers is the most sophisticated component and represents the largest part of the cost, it will be considered as the key element of the bidder's experience. For a joint venture, this requirement may be met by all members combined. Maximum number of members in the JV shall be three (3). There is specific minimum percentage of participation outlined in the bidding document, but it is crucial that every member’s role is clearly defined and substantial enough to demonstrate their active involvement in the contract execution. In case bidder wants to submit PO/DO instead of contract page, the bidder still need to demontrate the experience not only delivery part, but also shows experience on the related services (installation). Please refer to 2nd Amendment IHK Set
Package issued on 18-12-2024.
Supply Requirements Evaluation Process Specific Experience
39 2024-10-30 Price and Completion Schedule - Related Services Page 86
We would like to commend the MoH for considering life cycle costs for the IHK Set. We believe this is very important because the cost of consumables/reagents for the IHK Set are considerable over the course of 10 years compared to the initial cost of the main equipment. It is in the best interest of the MoH that bidders do not just put a low price for the equipment and then subsequently increase the price of consumables over the next 10 years.
With the interest of the MoH in mind, can MOH provide specific guidance on the full list of parameters for consumables/reagents that bidders should include in the life cycle costs? This will ensure that MoH is protected against significant price increases for consumables. Below is our recommendation of the key parameters to consider based on
national programs in Indonesia.
Below are some parameters that stated on several MoH documents:
1. Keputusan Menteri Kesehatan HK01.03/MENKES/6485/2021 This document regulates the mandatory parameters that should be tested before giving the treatment/ drugs based on PNPK or National Disease Guideline.
a. HER2 - ImmunoHistoChemistry (IHC) method for Breast Cancer > page 25, 45, 46, 56
b. HER2 - Chromogen In Situ Hybridization (ISH) method for Breast Cancer > page 45
c. Estrogen Receptor (ER)/ Progesterone Receptor (PR) for Breast Cancer > page 46
d. ALK (anaplastic lymphoma kinase) for Lung Cancer NSCLC > page 35
e. CD117 for Gastrointestinal Stromal Cancer > page 44
f. CD-20 for Lymphoma, Diffuse Large B-cell Lymphoma > page 54
g. CD-30 for Lymphoma Hodgkin > page 38
MoH with their new regulation No. HK01.03/MENKES/6485/2021 listed some companion diagnostics (CDx) therapy that need to be tested and has a positive result on certain cancers especially in Breast, Lymphoma and Lung Cancer.
Those therapies such as alectinib (ALK positive), lapatinib, (HER2 positive 3+) and rituximab (CD20 positive) need specific antibody or CDx
nse to the drugs based on the FDA CDx approval.
2. Peraturan Menteri Kesehatan No. 3 tahun 2023
This document regulates that IHC testing on Breast and Lymphoma Panel is already covered by National Health Insurance.
c. Breast Panel: Anti-Estrogen Receptor (ER), Anti-Progesterone Receptor (PR), Anti-Ki67, Anti-HER2/neu (page 21)
Lymphoma Panel: Anti-CD3, Anti-CD20, Anti-CD45, Anti-Ki67 (page
21)
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications. Supply Requirements Evaluation Process Qualification Requirements
40 2024-10-30 18.2 of 3. Technical Specifications under Section VII - Schedule of Requirements - page 122.
Can we confirm that the Material Safety Data Sheet (MSDS) is only required for the chemical reagents (consumables) and other chemical waste or by-products? Please kindly note that the main IHK equipment that does not produce chemical waste and therefore does not have an applicable MSDS.
Many thanks for this feedback. MoH will retain the current specification.
MSDS are for reagents
Supply Requirements Evaluation Process Qualification Requirements
41 2024-10-30 Additional Consumables Needed Row 208 Technical Specification Spreadsheet
We understand that bidders are required to indicate proposed consumables that will be needed to operate the IHK set in the proposed consumables tab.
1. We would like to clarify if the consumables should include reagent assays?
2. Reagent assays will depend on the procedures/antibody parameters that the users intend to run. As such, we would appreciate the MoH's clarification on which antibody parameters should be included in quoting the required consumables and reagents. It is important that the parameters are standard across bidders. Alignment on type of parameters that will be run could be refer to national clinical pathway (PNPK) or refer to national reimbursement program. (e.g state list of parameter with the reference of MoH Decree)
Below are some parameters that stated on several MoH documents:
1. Based on Minister of Health's Decree HK01.03/MENKES/6485/2021 This document regulates the mandatory parameters that should be tested before giving the treatment/ drugs based on PNPK or National Disease Guideline.
a. HER2 - ImmunoHistoChemistry (IHC) method for Breast Cancer > page 25, 45, 46, 56
b. HER2 - Chromogen In Situ Hybridization (ISH) method for Breast Cancer > page 45
c. Estrogen Receptor (ER)/ Progesterone Receptor (PR) for Breast Cancer > page 46
d. ALK (anaplastic lymphoma kinase) for Lung Cancer NSCLC > page 35
e. CD117 for Gastrointestinal Stromal Cancer > page 44
f. CD-20 for Lymphoma, Diffuse Large B-cell Lymphoma > page 54
g. CD-30 for Lymphoma Hodgkin > page 38
MoH with their new regulation No. HK01.03/MENKES/6485/2021 listed some companion diagnostics (CDx) therapy that need to be tested and has a positive result on certain cancers especially in Breast, Lymphoma and Lung Cancer.
Those therapies such as alectinib (ALK positive), lapatinib, (HER2 positive 3+) and rituximab (CD20 positive) need specific antibody or CDx assay to make sure patient's eligibility and respon to the drug based on the FDA CDx approval.
2. Based on Minister of Health's Decree No. 3 tahun 2023
This document regulates that IHC testing on Breast and Lymphoma Panel is already covered by National Health Insurance.
a. Breast Panel: Anti-Estrogen Receptor (ER), Anti-Progesterone Receptor (PR), Anti-Ki67, Anti-HER2/neu (page 21)
b. Lymphoma Panel: Anti-CD3, Anti-CD20, Anti-CD45, Anti-Ki67 (page 21)
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications. Supply Requirements Evaluation Process Qualification Requirements
42 2024-10-30 Recurrent Costs for Operation and Maintenance Page 86
According to paragraph (e), evaluation criteria on page 60, an adjustment to take into account additional Life Cycle Costs such as the
operating and maintenance costs will be added to the Bid Price for evaluation purposes only.
1. Given the instructions above, can you confirm that bidders are only required to include additional costs that are not included in the bid price when filling up the table for Recurrent Costs for Operation and Maintenance (page 86)?
1. This table, Recurrent Cost for Operation and Maintenance, expands beyond the table on related services as it includes the sub-total and total costs for all services needed for the operation and maintenance of the equipment including spare parts and consumables for years 1-5, which shall be included in the bid price, while an upfront quotation for years 6-10 will be used for the purpose of financial evaluation. Bidding Procedure Evaluation Process Financial Evaluation (including related services)
43 2024-10-30 Proposed Consumables Excel Tab Technical Specification Spreadsheet
We would like to clarify how bidders should fill the proposed consumables tab on the device specific excel spreadsheet:
1. The technical specifications requires bidders to quote start up consumables for 365 days of operation, however the proposed consumables tab in the excel spreadsheet indicates 5 years. We will appreciate a clarification if bidders are expected to quote consumables for 1yr only or for 5 years
1. Many thanks for this question. Consumables are items that are used up during the operation of a medical device and need to be regularly replaced. They are often intended for single use and are disposed of after use. Successful bidders are required to provide all consumables and accessories indicated in the relevant technical specification sheets, as well as any additional closed- loop/proprietary consumables and accessories needed for full functionality of device, as part of a starter kit. In addition to this, a fixed price for 5 years upon successful acceptance testing and commissioning shall be quoted for all consumables included in the starter pack, using the same units as in the starter pack. MoH reserves the right to request suppliers to deliver consumables in a staggered manner. Bidding Procedure Evaluation Process Qualification Requirements
44 2024-10-30 Section VII - Schedule of Requirements:
1. List of Goods and Delivery Schedule, p.93 Facility/site readiness criteria, last paragraph,
p. 116
We would like to clarify the Bidder's final date of delivery in the following scenario:
1. Bidder's offered Delivery Date for Lot 1, No. 1 destination (RS Umum Daerah Cut Meutia Kab. Aceh Utara) is 20-10-2026 (October 20th, 2026). This is within the indicated range of May 2025 to December 2026 as per List of Goods and Delivery Schedule, and meets the expected 2026 schedule on page 94.
2. In case the MoH notifies the bidder on January 5th, 2026 that the hospital is ready to receive the equipment. As mentioned in the special conditions of the contract, the bidder has 210 days to complete the delivery, installation, and commission. 210 after January 5th. 2026 is August 3rd 2026.
In such a scenario, can you kindly clarify if the deadline for delivery, installation, testing, and commissioning is October 20 or August 3?
Correct, The deadline for delivery, installation, testing, and commissioning is October 20, 2026 as per your understanding Contract Contract Management Contract
45 2024-10-30 1. Margin of Preference (ITB 37), Financial Part, under Section III Evaluation and Qualification Criteria - page 59
ITB 37.1, Section II - Bid Data Sheet - page 51
May we confirm if a Margin of Preference for goods manufactured in Member's Countries will apply?
We understand based on ITB 37.1, that a Margin of Preference shall not apply unless otherwise specified in the BDS.
However, a Margin of Preference to goods manufactured in the Member's Country (MC) is not mentioned in the BDS.
Thank you for your question. Margin of preference will not apply to this tender. Bidding Procedure Evaluation Process Evaluation Criteria
46 2024-10-30 Start up Consumables Row 204-208 Technical Specification Spreadsheet
Row 204-208 of the technical specification excel spreadsheet requires bidders to supply start up consumables for 365 days of operation, however it is unclear on how many procedures are expected per day or per 8hrs of operation.
1. We would like to clarify if the basis for start up consumables should be based on 60 IHC slides in 8hrs as mentioned on row 113 of the technical specifications?
2. We recommend setting a standard number across all bidders because higher throughput solutions are unfairly disadvantaged if they are required to bid consumables for 90 IHC slides capacity compared to other bidders with only 60 IHC slides capacity.
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications. Supply Requirements Evaluation Process Qualification Requirements
47 2024-10-30 ITB 10.1
Pursuant to ITB 10.1, we understand that the language of the Bid should be in English. In case the supporting documents are in Bahasa, should these still be translated to English (e.g., Articles of Incorporation in Bahasa)?
All language of the bid is English. The Bid, as well as all correspondence and documents relating to the Bid exchanged by the
Bidder and the Purchaser, shall be written in the language specified in the BDS. Supporting documents and printed literature that are part of the Bid may be in another language provided they are accompanied by an accurate translation of the relevant passages into the language specified in the BDS, in which case, for purposes of interpretation of the Bid, such translation shall govern. Please refer
to Section I - ITB, C, 10.1 Language of Bid.
Bidding Procedure Procurement Regulations Procurement Methodology
48 2024-10-30 Procurement Method
May we confirm that the RFB will follow open "International Competitive bidding" (ICB) Procedures as specified in IsDB'S Guidlines Procurement of Goods, Works and related services under Islamic Development Bank Project Financing (April 2019, revised in February 2023)?
We understand that open ICB allows bidders from all countries including non- member countries to participate and submit bid. The ICB Procedure is referenced in the Specific Procurement Notice (SPN);
however, the RFB does not explicitly state such.
This tender will follow open "International Competitive bidding" (ICB) Procedures to maintain the integrity and fairness of the procurement process by adhering to these regulations.
The IsDB is governed by the policies and principles agreed upon by its member countries, many of which are members of the Organization of Islamic Cooperation (OIC). Consequently, the IsDB Boycott regulation is a mandatory inclusion in our Procurement Guidelines and all related bidding documents.
Procurement under the project shall be carried out in accordance with IsDB’s Procurement Policy and Procedures through provisions contained in the IsDB’s
(i) Guidelines for the Procurement of Goods, Works and Related Services under IsDB Project Financing (April 2019 edition, revised in February 2023) and (ii) Guidelines for the Procurement of Consultants Services under IsDB Project Financing (April 2019 edition, revised in February 2023). Core procurement principles of the IsDB shall be respected throughout all procurement
transactions.
Bidding Procedure Procurement Regulations Procurement Methodology
49 2024-10-30 ITB 4.9 (b) - page 11 and IsDB Group AML & KYC Questionnaire, under Section IX Special Conditions of Contract - page 182
May we confirm if the "IsDB Group AML & KYC Questionnaire" Formss found on page 182 will need to be submitted as part of the bid submission or is this only required for the successful bidder?
IsDB Group AML & KYC Questionnaire Formss must provided by all prospective bidder in this tender, not only to successful bidder. Bidding Procedure Procurement Regulations Forms
50 2024-11-04 Regarding
Procurement Committee 4 - IHSS, Ministry of Health Republic of Indonesia
We are from PT. XXX want send our response about IHC Set specification bellow. We hope this response can be consider by Procurement Committee 4 - IHSS, Ministry of Health Republic of Indonesia. Thank you in advance
Many thanks for your interest in this Procurement of IHK Set. Any Firm from all countries that meet the required criteria are allowed to participate, however firms sanctioned under the IsDB Anti-Corruption Guidelines are not eligible to participate in the procurement process. To access documents related to IsDB rules and regulations, please kindly visit https://www.isdb.org/project- procurement/documents. The electronic version of the Bidding Document (including Technical Specification), can be downloaded from the following website: https://ihss.kemkes.go.id/ and look for Procurement of IHK Set.
Any amendment to the Bidding Document (if needed) and responses to clarification to the Bidding Document are also published on the same website.
Other Unrelated Questions Unrelated Questions
51 2024-11-07 5. Currently, only one brand (XXXX) is able to produce 5 out of the 6 devices in the Set, making the specifications and minimum joint venture member requirements highly advantageous to that brand. Many thanks for this feedback. MoH will retain the current specification.
Bidders are encouraged to split all components into individual equipment and float to bidders for better control and include various manufacturers and bidders.
Supply Requirements Evaluation Process Qualification Requirements
52 2024-11-07 8. Regarding equipment importation, if the holder of the distribution license is not a member of the JV, could you please provide clarification on this matter? Many thanks for the question. MoH recommend bidder to have JV with the license holder. As specified in the relevant Bidding Document, the possession of a Nomor Izin Edar (NIE, Distribution Permit Number) shall not be a pre-condition for the bidders to participate in the bidding process and shall not be the basis for rejection. In the event that a successful Bidder does not possess a NIE, they will be offered an accelerated track for registration before contract signing. Bidding Procedure Procurement Regulations Eligible Bidders (including joint venture)
53 2024-11-07 5. For the Minimum Specific Experience and the Manufacturer's Production Capacity, we kindly request that these not be mandatory in the SET. This requirement is quite challenging and burdensome for us as bidders, as each piece of equipment is different, with separate manufacturers, uses, and sales channels. If these must be considered for the SET, we suggest that the joint venture be expanded to 6 members, or alternatively, experience from just one key piece of equipment, namely the Automatic Immunohistochemistry Stainer, could be considered. Thank you for your question. We have revise the requirement as follows:
Based on the RFB, the bidder must be able to demonstrate experience in supplying and installing Microtomes annually in any one year and Automatic Immunohistochemistry Stainers annually in any one year within the last seven
(7) years. As the Microtomes and Automatic Immunohistochemistry Stainers is the most sophisticated component and represents the largest part of the cost, it will be considered as the key element of the bidder's experience. For a joint venture, this requirement may be met by all members combined. Maximum number of members in the JV shall be three (3). There is specific minimum percentage of participation outlined in the bidding document, but it is crucial that every member’s role is clearly defined and substantial enough to demonstrate their active involvement in the contract execution. In case bidder wants to submit PO/DO instead of contract page, the bidder still need to demontrate the experience not only delivery part, but also shows experience on the related services (installation). Please refer to 2nd Amendment IHK Set
Package issued on 18-12-2024.
Bidding Procedure Procurement Regulations Eligible Bidders (including joint venture)
54 2024-11-07 7. Could you please clarify the meaning of "Optical Accessories" in table row 164? Optical accessories describes Large Field Magnifier, Zoom-Stereomicroscope Bidding Procedure Evaluation Process Evaluation Criteria
55 2024-11-07 6. For the equipment specifications, items such as the Slide Printer (table row 159), Embedding Console (row 160), and Optical Accessories (table row 164) are separate devices with different units and specifications and are not part of a single Microtome system. Therefore, they should not be categorized as Accessories but rather as separate equipment requirements within the IHK Set. Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications. Supply Requirements Evaluation Process Qualification Requirements
56 2024-11-07 3. For the manufacturer’s experience requirement, we kindly request it to be set at 5 years. This is due to the fact that the equipment specified is advanced, and many manufacturers have only started production within the past 5 years. Thank you for your inquiry. The requirement for seven years of manufacturing experience on IHK Set equipment is based on market approach considering IHK Set is such of mature medical devices industries. Bidding Procedure Evaluation Process Qualification Requirements
57 2024-11-07 4. For the minimum specific experience and manufacturer’s production capacity, we request that it not be required as a SET. This requirement proses a significant challenge and burden for us as bidders, since each piece of equipment is different, with separate manufacturers, uses, and sales. If experience is required to be a SET, we suggest allowing a joint venture to include up to 6 members. Alternatively, it could be sufficient to require experience from only one primary piece of equipment, such as the Automatic Immunohistochemistry Stainer. Thank you for your question. We have revise the requirement as follows:
Based on the RFB, the bidder must be able to demonstrate experience in supplying and installing Microtomes annually in any one year and Automatic Immunohistochemistry Stainers annually in any one year within the last seven
(7) years. As the Microtomes and Automatic Immunohistochemistry Stainers is the most sophisticated component and represents the largest part of the cost, it will be considered as the key element of the bidder's experience. For a joint venture, this requirement may be met by all members combined. Maximum number of members in the JV shall be three (3). There is specific minimum percentage of participation outlined in the bidding document, but it is crucial that every member’s role is clearly defined and substantial enough to demonstrate their active involvement in the contract execution. In case bidder wants to submit PO/DO instead of contract page, the bidder still need to demontrate the experience not only delivery part, but also shows experience on the related services (installation). Please refer to 2nd Amendment IHK Set
Package issued on 18-12-2024.
Bidding Procedure Evaluation Process Qualification Requirements
58 2024-11-07 Good afternoon, Procurement Committee,
Allow me to introduce myself; I am XXX from PT XXX. We are interested in participating in the procurement of the IHK Set for the SIHREN IsDB project. We have a few questions and suggestions as follows:
1.If we, as a bidder, intend to participate in all lots (Lot 1 to Lot 4), will the minimum specific experience and the manufacturer’s production capacity requirements in the RFB document be cumulative (i.e., totaling 150 units across Lots 1-4) or will each lot follow its own experience requirement? If possible, we suggest not making it cumulative so that more vendors may participate.
Thank you for your question. The same specific experience documents can be used repeatedly for different lots provided that meet the minimum requirement for the each respective lots. Each lot must be supported by documentation that demonstrates the necessary experience specifically for that lot.
In case one bidder is to be recommended to be awarded the contract for more than one lot, such bidder shall meet the cumulative minimum requirement of point (a) financial capability and (b) specific experience respective lots. The contract will be determined based on the most advantageous bids. Refer to the RFB, Technical Part, Section III Evaluation and Qualification Criteria
Other Unrelated Questions Unrelated Questions
59 2024-11-07 9. We kindly request that, given the numerous questions and suggestions from various vendors, the document submission deadline be postponed until January 2025.
These are our questions, and we hope they will be answered in detail. We also ask that our suggestions be considered to allow wider vendor participation beyond specific brands.
Thank you for your attention.
Many thanks for your interest in this Procurement of IHK Set. The Bid Submission Deadline for IHK Set is still set in December, 9th 2024 . Please visit the website regularly to get the update. Any amendment to the Bidding Document (if needed), responses to clarification to the Bidding Document, and schedule are also published on IHSS website. Supply Requirements Evaluation Process Qualification Requirements
60 2024-11-07 2. We plan to enter a joint venture with the manufacturer of these products. In this case, is the minimum specific installation experience still required? If possible, we suggest that only the manufacturer’s production capacity be considered. Please refer to the respective response on the question #ITB 32.1. Minimum specific experience still required for JV case. The Bidder shall demonstrate that it has successfully and substantially completed of similar
Goods and Related Services (installation). For a joint venture, this requirement may be met by all members combined. In case bidder wants to submit DO instead of contract page, the bidder still need to demontrate the experience not only delivery part, but also shows experience on the related services (installation)
Bidding Procedure Procurement Regulations Eligible Bidders (including joint venture)
61 2024-11-08 5. Only one brand (XXXX) is capable of producing 5 out of the 6 equipment items in the SET, so the specifications and minimum joint venture member requirements are highly advantageous for that particular brand. Many thanks for this feedback. MoH will retain the current specification.
Bidders are encouraged to split all components into individual equipment and float to bidders for better control and include various manufacturers and bidders.
Supply Requirements Evaluation Process Qualification Requirements
62 2024-11-08 I have attended yesterday afternoon pre bid conference, I have the following questions regarding the tender that I hoped I can get a clear answer
1. In regards to the JV requirement: Can my bidder and my company enter into a distribution agreement, clearly indicated in our Letter of Intent (LOI) when submitting the tender that we will Forms this distribution agreement as a Forms of JV? Is this Forms of “JV” approved by the tender board?
There is specific minimum percentage of participation outlined in the bidding document, but it is crucial that every member’s role is clearly defined and substantial enough to demonstrate their active involvement in the contract execution. This must be reflected in the joint venture agreement and the bid submission, ensuring all members are equally responsible and accountable for the success of the project. Regarding AATO in JV: Lead Partner must meet minimum forty percent (40%) of the total AATO requirement while each partner must meet minimum twenty percent (20%). Bidding Procedure Procurement Regulations Eligible Bidders (including joint venture)
63 2024-11-08 3. If bidder cannot provide specific contracts to prove our specific experiences, what Formsal letter, letter provided by who, does the tender board needs before we are allow to provide just purchase order/deliver order to the tender board?
Thank you and best regards
The Bidder shall demonstrate that it has successfully and substantially completed of similar Goods and Related Services (installation). For a joint venture, this requirement may be met by all members combined. In case bidder (either as manufacturer or principle/distributor/sole agent) wants to submit PO/DO instead of contract page, the bidder still need to demontrate the experience not only delivery part, but also shows experience on the related services (installation). Bidding Procedure Evaluation Process Specific Experience
64 2024-11-08 7. Regarding the importation of equipment, please clarify if the holder of the distribution permit is not a member of the JV. Please refer to the respective response on the question #21. Bidding Procedure Evaluation Process Evaluation Criteria
65 2024-11-08 9. Given the number of questions and input from various vendors, we kindly request that the deadline for document submission be extended until January 2025.
Thank you for your attention and for considering our suggestions.
Please refer to the respective response on the question #22. Other Unrelated Questions Unrelated Questions
66 2024-11-08 8. We kindly request clarification on the definition of "Optical Accessories" in table row 164. Optical accessories describes Large Field Magnifier, Zoom-Stereomicroscope Bidding Procedure Evaluation Process Evaluation Criteria
67 2024-11-08 Dear Procurement Committee Team 4,
We would like to submit several questions and suggestions regarding the IHK SET procurement, as follows:
1. If we are interested in participating as a bidder in all lots (Lot 1-Lot 4), will the minimum specific experience and the manufacturer's production capacity stated in the RFB document be cumulative (totaling 150 units across Lot 1–Lot 4) or will they follow the experience requirements of each individual lot? If possible, we suggest not making it cumulative to allow more vendors to participate.
Please refer to the respective response on the question #18. General Inquiry Related to Proc Plan and Packaging Arr. Question related to Procurement Planning and Packaging Arrangements
68 2024-11-08 Dear Sir/Madam,
Hope my email finds you well,
I am XXX, work for XXX, which is one of the top immunohistochemistry manufacturers in China. I am very interested in this tender.
Thanks for the pre-bid meeting you organized yesterday, it's very helpful for us. Here I would like to propose some suggestions from my side for your reference.
1. Is it possible to shorten the years of manufacturing experience to 6 years, or
even 5 years?
Please refer to the respective response on the question #20. Bidding Procedure Evaluation Process Qualification Requirements
69 2024-11-08 2. We are planning to Forms a joint venture with the manufacturer of these equipment. Will the minimum specific installation experience still be required? If possible, we suggest that only the manufacturer's production capacity be considered. Thank you for your question. We have revise the requirement as follows:
Based on the RFB, the bidder must be able to demonstrate experience in supplying and installing Microtomes annually in any one year and Automatic Immunohistochemistry Stainers annually in any one year within the last seven
(7) years. As the Microtomes and Automatic Immunohistochemistry Stainers is the most sophisticated component and represents the largest part of the cost, it will be considered as the key element of the bidder's experience. For a joint venture, this requirement may be met by all members combined. Maximum number of members in the JV shall be three (3). There is specific minimum percentage of participation outlined in the bidding document, but it is crucial that every member’s role is clearly defined and substantial enough to demonstrate their active involvement in the contract execution. In case bidder wants to submit PO/DO instead of contract page, the bidder still need to demontrate the experience not only delivery part, but also shows experience on the related services (installation). Please refer to 2nd Amendment IHK Set
Package issued on 18-12-2024.
Bidding Procedure Evaluation Process Specific Experience
70 2024-11-08 2. Row 204 to 207 – we wish to understand the number of tests done per year. So that we can calculate the quantity for 365 days usage. As the number of tests depends on the patient numbers and surgical procedures, we suggest to offer standard set quantity from manufacturer as unit quantity in financial part.
We would greatly appreciate it if you could provide us with the necessary inFormsation and answers to our questions at your earliest convenience. This will enable us to prepare a comprehensive and competitive tender proposal.
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications. Supply Requirements Evaluation Process Qualification Requirements
71 2024-11-08 4. For the Minimum Specific Experience and Manufacturer’s Production Capacity, we kindly request that these not be mandatory in the SET. This requirement is quite challenging and burdensome for us as bidders, as each piece of equipment is different, with separate manufacturers, uses, and sales channels. If these must be considered as SET experience, we suggest that the joint venture consist of 6 members, or alternatively, the experience requirement could be based on just one key piece of equipment, namely the Automatic Immunohistochemistry Stainer. Thank you for your question. We have revise the requirement as follows:
Based on the RFB, the bidder must be able to demonstrate experience in supplying and installing Microtomes annually in any one year and Automatic Immunohistochemistry Stainers annually in any one year within the last seven
(7) years. As the Microtomes and Automatic Immunohistochemistry Stainers is the most sophisticated component and represents the largest part of the cost, it will be considered as the key element of the bidder's experience. For a joint venture, this requirement may be met by all members combined. Maximum number of members in the JV shall be three (3). There is specific minimum percentage of participation outlined in the bidding document, but it is crucial that every member’s role is clearly defined and substantial enough to demonstrate their active involvement in the contract execution. In case bidder wants to submit PO/DO instead of contract page, the bidder still need to demontrate the experience not only delivery part, but also shows experience on the related services (installation). Please refer to 2nd Amendment IHK Set
Package issued on 18-12-2024.
Bidding Procedure Evaluation Process Specific Experience
72 2024-11-08 6. For the equipment specifications, accessories such as the Slide Printer (table row 159) and Embedding Console (row 160), as well as Optical Accessories (table row 164), are different equipment, different units, and have different specifications. They are not part of the same unit as the microtome, and therefore, should not be considered as accessories. Instead, they should be classified as equipment requirements within the IHK Set. Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications. Supply Requirements Evaluation Process Qualification Requirements
73 2024-11-08 2. If we, as a bidder, intend to participate in all lots (Lot 1–Lot 4), will the minimum specific experience and the manufacturer's production capacity stated in the RFB document be cumulative (totaling 150 units across Lot 1–Lot 4) or follow the experience requirements of each individual lot? If possible, we suggest not making it cumulative, as this would encourage broader participation from various vendors. Thank you for your question. The same specific experience documents can be used repeatedly for different lots provided that meet the minimum requirement for the each respective lots. Each lot must be supported by documentation that demonstrates the necessary experience specifically for that lot.
In case one bidder is to be recommended to be awarded the contract for more than one lot, such bidder shall meet the cumulative minimum requirement of point (a) financial capability and (b) specific experience respective lots. The contract will be determined based on the most advantageous bids. Refer to the RFB, Technical Part, Section III Evaluation and Qualification Criteria
General Inquiry Related to Proc Plan and Packaging Arr. Question related to Procurement Planning and Packaging Arrangements
74 2024-11-08 Good Morning, Procurement Committee Team 4,
We are representatives from XXX, and we have several questions and suggestions regarding the IHK Sihren package, as follows:
1. Regarding the importation procedure for the equipment, if the holder of the distribution permit is not a member of the JV, is it possible? What would be the mechanism if they were to become the winner?
Many thanks for the question. As specified in the relevant Bidding Document, the possession of a Nomor Izin Edar (NIE, Distribution Permit Number)/License shall not be a pre-condition for the bidders to participate in the bidding process and shall not be the basis for rejection. In the event that a successful Bidder does not possess a NIE/License, they will be offered an accelerated track for registration before contract signing. It is possible for the bidder to import the equipment directly, but this depends on whether the equipment is subject to any exclusivity agreements. If such agreements exist, the equipment may need to be imported through the license holder and recommend to have JV with the license holder. Contract Contract Management Contract
75 2024-11-08 Good morning, Procurement Committee of the IHK Set World Bank Working Group,
We are from PT XXX, and we would like to kindly ask if the presentation materials from yesterday's session could be shared with us, as the pre-bid presentation materials are not yet available on the IHSS link.
Thank you very much.
Many thanks for your interest in this IHK Set tender. The presentation file from the Pre-Bid Meeting on November 7th will be published on our official website at https://ihss.kemkes.go.id/ soon. Please check the website periodically for updates. Other Unrelated Questions Unrelated Questions
76 2024-11-08 6. Given the number of questions and input from various vendors, we kindly request that the submission deadline for documents be extended until January 2025.
Thank you for your attention and kind consideration.
Please refer to the respective response on the question #22. Other Unrelated Questions Unrelated Questions
77 2024-11-08 4. Regarding the manufacturer's experience, we kindly request that it be set to 5 years, as the equipment specified is advanced technology, and many manufacturers have only started production within the past 5 years. Please refer to the respective response on the question #20. Bidding Procedure Evaluation Process Qualification Requirements
78 2024-11-08 2. The tender required the capacity of IHK manufacter should be at least 250 set per year, is it possible to reduce it to 200 sets? Because the annual capacity of 250 sets for IHC stainer is a very big number.
Highly appreciate your understanding, and looking forward to hearing from you.
Many thanks for this feedback. MoH will retain the current requirement. Please refer to RFB Sedtion III- Evaluation and Qualification Criteria, Technical Part, 1.Qualification, d. Manufacturing experience and Technical Capacity, Page 55 Bidding Procedure Evaluation Process Evaluation Criteria
79 2024-11-08 3. We are planning to Forms a joint venture with the manufacturer of the equipment. Will the minimum specific installation experience still be required? If possible, we suggest that only the manufacturer's production capacity be considered. Draft Response:
Thank you for your question. Prospective bidders should fulfill all the qualification criteria both finacial capacity (regardless as a manufacturer or not) and specific experience as specified in the bidding document. For financial capacity, bidder must meet the Average Annual Turn Over (AATO) for the last 3 years equal to specified number per lot (refer to ITB 32.1)
For Bidders’ specific experience:
• Bidders should have experience in supplying IHK Set equipment with specific minimum quantity specified in the BD in any of year within the last seven (7) years
• Manufacturer’s authorization is required for non manufacturer bidders, the Bidder shall provide evidence of being duly authorized by a manufacturer (Manufacturer’s Authorization Forms, Section IV, Bidding Formss), meeting the criteria mentioned above, to supply the Goods;
• If the bidder is a manufacturer (OEM):
it has manufactured IHK Set for at least seven
(7) years, prior to the bid submission deadline; and
its annual production capacity of IHK Set for each of the last seven (7) years prior to the bid submission deadline, is at least 30% the quantities specified under this package.
In case the Bidders are not manufacturers, they may use the past Specific Experience of the Manufacturer, in Forms of Joint Venture.
Bidding Procedure Evaluation Process Specific Experience
80 2024-11-08 3. Regarding the manufacturer's experience, we kindly request that it be set to 5 years, as the equipment specified are advanced technologies, and many manufacturers have only started production within the past 5 years. Please refer to the respective response on the question #20. Bidding Procedure Evaluation Process Qualification Requirements
81 2024-11-08 2. The IHK set consist of Fridge for the reagent. However as most or all of the tissue diagnostics companies do not manufacture fridge, we will not be able to provide our experience document to the tender board. Can you consider to remove the requirement to submit experience on supplying the fridge and to focus on the experience in the key specialized equipment in the IHK set? Many thanks for this feedback. MoH will retain the current specification.
The IHK package as per MOH requirement includes the Reagent Refrigerator. Bidder is encourage to comply to all equipment required in this package.
Supply Requirements Evaluation Process Qualification Requirements
82 2024-11-08 Dear Sir/Madam,
I hope this email finds you well.
My name is XXXX, and I represent XXXX, a leading provider of medical equipment and solutions. We are writing to seek clarification on some matters related to the IHK tender in Indonesia.
Please refer to the attachment for details.
Firstly, we would like to express our keen interest in participating in the tender process. We believe that our products and services can significantly contribute to the healthcare sector in Indonesia. Below, please find a list of questions we have regarding the tender:
Technical Specification
1. Row 11 – Must the supplier need to fulfill both US FDA and CE mark or either on is acceptable? As Medical Device registration required either one of the approvals, we request not necessary both but comply with any one is acceptable for this tender.
If NIE not alloted as of yet, bidder to provide evidence (U.S. FDA Clearance, CE Mark (ConFormsité Européenne mark) (MDD), or other health, safety and environmental standard adherence).
NIE will not be a prerequisite at bidding stage, yet required for contract award. Bidder to specify whether NIE has already been alloted, as detailed in the bidding document. Please see requirements for technical spesification row number 10 and 11 in any of lot. The contract award includes NIE as a prerequisite; no other registration license will be accepted.
Contract Contract Management Contract
83 2024-11-10 b. Our suggestion is that the Slide Printer (row 159), Embedding Console (row 160), and Optical Accessories (row 164) are separate units and should not be considered part of the Microtome section. We recommend treating them as separate items in the IHK Set rather than as accessories. Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications. Supply Requirements Evaluation Process Qualification Requirements
84 2024-11-10 c. What is meant by Workflow Organizer (row 195)? Workflow Organizers are integral components designed to enhance laboratory efficiency and streamline processes. They encompass various tools and accessories that facilitate the organization and management of slides, reagents, and staining protocols.
For example Slide Staining Trays and Racks, Reagent Dispensing Systems, Slide Labelling and Tracking Accessories, Automated Slide Stainers, Waste Management Systems
Bidding Procedure Evaluation Process Evaluation Criteria
85 2024-11-10 4.Can a single company be a member of two different joint ventures for separate lots?
If so, would it be possible to propose the same type of equipment for each lot, or would it also be acceptable to propose different types of equipment for the different lots?
A Bidder either individually or as a joint venture member, is permitted to submit a bid for an individual lot, or any combination of lots under a particular package, provided they meet all eligibility requirements stipulated in the relevant Bidding Documents, do not have a conflict of interest, and are not participating in more than one Bid, except for permitted alternative Bids.
In case one Bidder is to be recommended to be awarded the contract for more than one lot, such Bidder shall meet the cumulative minimum requirements of the respective lots. The contract will be determined based on the most advantageous Bids.
Contract Contract Management Contract
86 2024-11-10 2.Could the required manufacturing experience be reduced to 5 years?
Considering that the main IHK Set equipment is advanced and, so far, has primarily been required by major hospitals or those located in large cities only.
Please refer to the respective response on the question #20. Bidding Procedure Evaluation Process Qualification Requirements
87 2024-11-10 Good afternoon, Mr./Ms. Procurement Committee,
Allow me to introduce myself; my name is XXX from PT. XXX.
In relation to the SIHREN IsDB project for the IHK Set, we have the following questions:
Regarding the Excel document, Technical Part -> ACCESSORIES REQUIRED FOR EACH CLINICAL APPLICATION/PROCEDURES:
a. What is meant by Optical Accessories (row 164)?
Optical accessories describes Large Field Magnifier, Zoom-Stereomicroscope Bidding Procedure Evaluation Process Evaluation Criteria
88 2024-11-10 3.If participating in all four lots, can the minimum experience and production capacity be calculated cumulatively, or must it adhere to the requirements of each individual lot?
We hope that the requirements will follow each lot individually to provide greater opportunities for bidders.
Please refer to the respective response on the question #18. Other Unrelated Questions Unrelated Questions
89 2024-11-11 3.Joint Venture
Currently, only one brand is capable of producing 5 out of the 6 instruments in the set, which means that the specifications and minimum joint venture requirements favor this brand alone. Could this be taken into consideration?
We kindly request that you take into account the questions and suggestions from various vendors and consider extending the document submission deadline.
Thank you very much for your attention.
Thank you for your question. We have revise the requirement as follows:
Based on the RFB, the bidder must be able to demonstrate experience in supplying and installing Microtomes annually in any one year and Automatic Immunohistochemistry Stainers annually in any one year within the last seven
(7) years. As the Microtomes and Automatic Immunohistochemistry Stainers is the most sophisticated component and represents the largest part of the cost, it will be considered as the key element of the bidder's experience. For a joint venture, this requirement may be met by all members combined. Maximum number of members in the JV shall be three (3). There is specific minimum percentage of participation outlined in the bidding document, but it is crucial that every member’s role is clearly defined and substantial enough to demonstrate their active involvement in the contract execution. In case bidder wants to submit PO/DO instead of contract page, the bidder still need to demontrate the experience not only delivery part, but also shows experience on the related services (installation). Please refer to 2nd Amendment IHK Set
Package issued on 18-12-2024.
Bidding Procedure Procurement Regulations Eligible Bidders (including joint venture)
90 2024-11-11 2.Manufacture History
In the Zoom meeting held on Thursday, November 7, 2024, it was mentioned that the manufacturer must have more than 7 years of experience.
Would it be possible for a manufacturer with experience slightly below or close to 7 years to participate in this project, considering the manufacturer’s specific expertise and the advanced specifications of the equipment?
Given that many manufacturers of modern, sophisticated equipment have only begun production within the last five years, we kindly ask the Procurement Committee to take this into consideration.
Please refer to the respective response on the question #20. Supply Requirements Evaluation Process Qualification Requirements
91 2024-11-11 Good morning, Mr./Ms. Procurement Committee,
Allow me to introduce myself; my name is XXX from PT XXX.
Regarding the SIHREN IsDB project for the IHK Set, we have several questions as outlined below:
Specific Experience in Installation
In this project, we will be entering into a joint venture with several manufacturers. Given the minimum specific experience in installation requirements, will this criterion apply to each accessory individually?
As outlined in Section III - Evaluation and Qualification Criteria and ITB 4.1 of the RFB, the requirement for installation experience applies to the scope of the project as defined in the bid document. In a joint venture, the members can collectively meet the minimum qualifications, with the experience of one member compensating for the others if necessary. Regarding accessories, the specific installation requirements depend on the technical details provided in Section VII - Schedule of Requirements. For further clarification on whether this applies to each accessory individually, bidders are encouraged to submit their questions to the email specified in ITB 7.1. Bidding Procedure Evaluation Process Rated Criteria (Scoring Methodology)
92 2024-11-13 2. The PO issued from the distributor to the manufacturer and/or, even better as proof of real delivery of the products, DO from the manufacturer to the distributor and/or a reference list provided by the manufacturer In order to demonstrate it meets the experience requirement at minimum, the Bidder shall furnish detailed inFormsation regarding contracts completed: the purchaser’s name and address, country, name and object of the contract, scope of services, date of contract completion, equipment supplied, contract amount, contract role (prime supplier, subcontractor, partner in Joint Venture) and percent of the contract value undertaken by subcontract. As a proof of the compliance, the Bidder shall provide copies of relevant pages of signed contracts and corresponding completion certificates. If any such contract includes a confidentiality/non-disclosure clause and the Bidder does not agree to provide a copy (to be confirmed by a Formsal letter), such bidder must provide other documents acceptable for the Purchaser (such as copy of purchase order/delivery order). Contract Contract Management Contract
93 2024-11-13 Reference:
Completion Certificate/ Installation Report Page 55
Request and Clarification:
On page 55 of the RFB, the Bidder is required to provide both installation report and PO/DO to prove experience qualifications.
However, pre-analytic equipment such as hot plate and water bath are very simple plug-and-play solutions and therefore it is not common to have installation reports for such equipment.
As such, we would like to request the MoH to accept PO/DO as proof of experience for pre-analytic equipment instead of both PO/DO and installation reports and to remove hot plates and water baths from such
requirement.
Please refer to the respective response on the question #2. Bidding Procedure Evaluation Process Specific Experience
94 2024-11-13 Reference:
Reagent Refrigerator
Technical Specification Excel Sheet Request and Clarification:
We would like to propose that the reagent refrigerator listed as one of the main equipment be moved to the accessories section of the technical specification sheet instead. For example, the slide printer is also a separate type of equipment, but it is listed as an accessory to the microtome.
Below are important factors we would like to highlight to substantiate our request:
Limited Competition/Risk for Re-tendering: We would like to highlight that refrigerators are not part of the product portfolio of any IHC or Preanalytic anufacturing company therefore not only it is impossible for any bidder to prove the number of installations requested but also to provide any of the documents requested by this clause unless a refrigerator company joins a JV.
Given that only 1 company (Leica) can provide all the other 5 instruments and combined with the significant volume that is required under the tender, there will be no company that can bid even in a joint venture except for 1 company given the JV members are limited to only 3 companies. Other IHC firms will need to Forms JVs just to meet the experience requirement for the main IHC analyzer.
Proposed Solution: We would like to propose that the reagent refrigeratorbe moved as an accessory to the IHC analyzer instead. For example, the slide printer is also a separate type of equipment, but it is listed as an accessory to the microtome.
This will allow the MoH to procure the desired refrigerator equipment but still receive cost-effective bids. It is in the best interest of MoH to have the broadest possible competition and this is also supported by IsDB procurement guideline clause 1.40 that says the bid document shall promote the roadest possible competition.
Many thanks for this feedback. MoH will retain the current specification.
The IHK package as per MOH requirement includes the Reagent Refrigerator. Bidder is encourage to comply to all equipment required in this package.
Supply Requirements Evaluation Process Qualification Requirements
95 2024-11-13 Reference:
Specific Experience PO/DO as proof of past experience Page 55
Request and Clarification:
We would like to thank the MoH for confirming during the pre-bid meeting on November 07, 2024 that bidders may use deliveries/installations done through distributors provided that it supported with the appointment letter to the distributor and supported by the PO/DO to the distributor as well.
We would kindly appreciate your written confirmation on this topic. For reference, below is the rationale for our request:
1. In the B2B market, the purchase orders from the distributors are issued
to the manufacturer upon orders from the end users to the distributor or after tenders are awarded to the same
Thank you for your question. We have revise the requirement as follows:
Based on the RFB, the bidder must be able to demonstrate experience in supplying and installing Microtomes annually in any one year and Automatic Immunohistochemistry Stainers annually in any one year within the last seven
(7) years. As the Microtomes and Automatic Immunohistochemistry Stainers is the most sophisticated component and represents the largest part of the cost, it will be considered as the key element of the bidder's experience. For a joint venture, this requirement may be met by all members combined. Maximum number of members in the JV shall be three (3). There is specific minimum percentage of participation outlined in the bidding document, but it is crucial that every member’s role is clearly defined and substantial enough to demonstrate their active involvement in the contract execution. In case bidder wants to submit PO/DO instead of contract page, the bidder still need to demontrate the experience not only delivery part, but also shows experience on the related services (installation). Please refer to 2nd Amendment IHK Set
Package issued on 18-12-2024.
Supply Requirements Evaluation Process Specific Experience
96 2024-11-13 3. Manufacturing and supplying of such products is only upon end user's official order or after a tender is awarded and that, consequently, the value as aproof of manufacturing and installation experience of a DO from amanufacturer to a distributor is equivalent to an installation report being the last the direct consequence of the first
Thank you for the opportunity to submit our clarifications and we look forward to receiving your feedback.
Sincerely,
Please refer to the respective response on the question #189. Contract Contract Management Contract
97 2024-11-13 Dear Sir/mdm
With reagrds to the payment schedule,
On Shipment: Twenty-five (25%) percent of the Unitary Contract Price of the quantity of Goods shipped shall be paid through irrevocable confirmed letter of credit opened in favor of the Supplier in a bank in its country, upon submission of documents specified in GCC Clause 13.
Question: As for joint venture propsoal, teh goods will be shipped Forms different port of origin, will the letter of credit be address to lead bidder or to the individual emebers of the joint venture? Please calrify.
As stated in GCC 13.1 and SCC 16.1 of the RFB, payment through an irrevocable confirmed letter of credit (LC) will be issued to the party responsible for delivering the goods as specified in the contract. In the case of a joint venture, the LC will typically be addressed to the lead member of the JV, as the lead member is responsible for coordinating all activities and communications with the Purchaser. If goods are shipped from multiple ports of origin, the lead member must ensure proper documentation and coordination with other members to fulfill the requirements under GCC Clause 13. Contract Contract Management Payment Term
98 2024-11-13 As official representative of XXXX, I’m hereby submitting to your attention our requests for clarifications for the Procurement of IHK set, KS.01.02/A. VI/6167/2024
Thank you in advance for your attention Dear Procurement Committee 4:
We are writing to seek additional clarification on the following questions,
pursuant to Instructions to
Bidder (ITB 7.1) of the bidding documents:
Reference:
Manufacturing Experience and Technical Capacity Page 55
Manufacturing experience and Technical Capacity: For the items under the Contract that the bidder is a manufacturer, the Bidder shall furnish documentary evidence to demonstrate that: (i) it has manufactured IHK Set equipment for at least seven (7) years, prior to the bid submission deadline; and (ii) its annual production capacity of IHK Set equipment for each of the last seven (7) years prior to the bid submission deadline, is at east 50% the quantities specified under each lot.
Request and Clarification:
On page 55, the bid document requires the Bidder to demonstrate that its annual production capacity of IHK Set Equipment for each of the last 7 years, is at least 50% of the quantities specified under each lot (which is equivalent to 250 units total for 4 lots).
Clarification/Request:
We would like to request your confirmation that this requirement can be met if the bidder can demonstrate the required manufacturing capacity of 50% for pre-analytic equipment specific for histopathology COMBINED (i.e. microtome, cold plate, hot plate, water baths, tissue processors, grossing stations, embedding systems, H&E stainers, ventilated cabinets). This would mean that manufacturing experience of 1 microtome and 1 tissue rocessor would count as 2 units in a year).
Below are important factors we would like to highlight to substantiate ourrequest/clarification:
Main Analyzer vs Pre-Analytic Equipment: The required manufacturing capacity is appropriate for the main IHC analyzer (automatic IHC stainer) since there is a larger analyzer market worldwide. However, the global market for the required pre-analytic equipment such as cold plate, hot plate, and microtomes is very fragmented with only a few high-quality manufacturers sharing a niche market where the quantities are very limited.
Limited Competition/Risk for Re-tendering: We are confident to state that if the bid requires 250 units per year individually for each pre-analytical
equipment, 99% of the pre-analytic manufacturers will not be able to bid even in a JV. Only 1 company in the world (Leica Biosystem) will be capable of meeting such manufacturing requirements. The risk for the committee is to have a tender with limited competition leading to higher costs for the purchaser and only 1 bidder on one or more or even all the lots of this tender.
Proposed Solution: The proposed solution to allow bidders to meet the required manufacturing capacity of 50% of the lot quantity annually for the last 7 years using manufacturing experience for pre-analytic equipment specific for histopathology COMBINED will allow the MoH to receive cost competitive bids while still maintaining a high quality standard for the last 7 years.
Please refer to the respective response on the question #20. Bidding Procedure Evaluation Process Qualification Requirements
99 2024-11-13 Reference:
Specific Experience
PO/DO as proof of past experience Page 55
Request and Clarification:
We would like to thank the MoH for confirming during the pre-bid meeting on November 07, 2024 that bidders may use deliveries/installations done through distributors provided that it supported with the appointment letter to the distributor and supported by the PO/DO to the distributor as well.
We would kindly appreciate your written confirmation on this topic. For reference, below is the rationale for our request:
1. In the B2B market, the purchase orders from the distributors are issued to the manufacturer upon orders from the end users to the distributor or after tenders are awarded to the same
2. The PO issued from the distributor to the manufacturer and/or, even better as proof of real delivery of the products, DO from the manufacturer to the distributor and/or a reference list provided by the manufacturer
3. Manufacturing and supplying of such products is only upon end user's official order or after a tender is awarded and that, consequently, the value as a proof of manufacturing and installation experience of a DO from a manufacturer to a distributor is equivalent to an installation report being the last the direct consequence of the first
Please refer to the respective response on the question #2. Bidding Procedure Evaluation Process Specific Experience
100 2024-11-13 Reference:
Completion Certificate/Installation Report Page 55
Request and Clarification:
On page 55 of the RFB, the Bidder is required to provide both installation report and PO/DO to prove experience qualifications.
However, pre-analytic equipment such as hot plate and water bath are very simple plug-and-play solutions and therefore it is not common to have installation reports for such equipment.
As such, we would like to request the MoH to accept PO/DO as proof of experience for pre-analytic equipment instead of both PO/DO and installation reports and to remove hot plates and water baths from such requirement.
Thank you for your question. We have revise the requirement as follows:
Based on the RFB, the bidder must be able to demonstrate experience in supplying and installing Microtomes annually in any one year and Automatic Immunohistochemistry Stainers annually in any one year within the last seven
(7) years. As the Microtomes and Automatic Immunohistochemistry Stainers is the most sophisticated component and represents the largest part of the cost, it will be considered as the key element of the bidder's experience. For a joint venture, this requirement may be met by all members combined. Maximum number of members in the JV shall be three (3). There is specific minimum percentage of participation outlined in the bidding document, but it is crucial that every member’s role is clearly defined and substantial enough to demonstrate their active involvement in the contract execution. In case bidder wants to submit PO/DO instead of contract page, the bidder still need to demontrate the experience not only delivery part, but also shows experience on the related services (installation). Please refer to 2nd Amendment IHK Set
Package issued on 18-12-2024.
Supply Requirements Evaluation Process Technical Evaluation
101 2024-11-14 Row Number : 184
Existing Spec :Stainless Steel Petri Dish Rack
Proposed Spec:
Remarks : Not applicable in pathology anatomy laboratory
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications.
Agreeable to the bidder's suggestion to amend to preferred.
Supply Requirements Evaluation Process Qualification Requirements
102 2024-11-14 Row Number : 97
Existing Spec :Preferred; up to 594 L
Proposed Spec: Propose change to general spec, Volume 200-300L Remarks : Capacity of 594 L is too big for immunohistochemistry
Many thanks for this feedback. As this specification is rated criteria, the bidder can choose to comply or not. MoH will retain the current specification.
Specification provides a maximum range, bidder to specify their capacity. It is highly dependant on the frequency and volume of use.
Supply Requirements Evaluation Process Qualification Requirements
103 2024-11-14 Row Number : 37 Existing Spec : 1 - 60 µm
Proposed Spec: Proposed change as general spec, example 0,50 - 100 μm Remarks :
Many thanks for this feedback. As this specification is mandatory, the bidder can choose to comply or not. MoH will retain the current specification.
Maintain neutral tech specs with smaller ranges is preferred as it would include more devices.
Supply Requirements Evaluation Process Qualification Requirements
104 2024-11-14 Row Number : 39
Existing Spec :"1 - 10 µm (in 1 µm increments) 10 - 20 µm (in 2 µm increments)
20 - 60 µm (in 5 µm increments)"
Proposed Spec: "Proposed change as general spec, example :0.5 - 5.0 μm in 0.5 μm increments
5.0 - 20.0 μm in 1.0 μm increments
20.0 - 60.0 μm in 5.0 μm increments
60.0 - 100.0 μm in 10.0 μm increments"
Remarks :
Many thanks for this feedback. As this specification is mandatory, the bidder can choose to comply or not. MoH will retain the current specification.
Bidder's suggestion may be restrictive and suggested increments shall exclude other proposed models/ devices.
Supply Requirements Evaluation Process Qualification Requirements
105 2024-11-14 Row Number : 30
Existing Spec : 40 µm (can be turned off)
Proposed Spec:Proposed change as general spec, example 5 - 100 μm in 5 μm increments
Remarks : Leads to one or a particular brand of product Epredia HM 340E & HM 3455S.
Many thanks for this feedback. As this specification is mandatory, the bidder can choose to comply or not. MoH will retain the current specification.
40 µm is within the proposed range of 5 - 100 µm; 5 µm increments shall exclude other proposed models/ devices.
Supply Requirements Evaluation Process Qualification Requirements
106 2024-11-14 Row Number : 66
Existing Spec : Digital, Microprocessor
Proposed Spec: Proposed change as general spec, electronic/touch button Remarks :
Many thanks for this feedback. As this specification is mandatory, the bidder can choose to comply or not. MoH will retain the current specification.
The range ensures modern hot plates with more accurate temperature control.
Supply Requirements Evaluation Process Qualification Requirements
107 2024-11-14 Row Number : 75
Existing Spec : ≤ 60 blocks
Proposed Spec: Proposed to bigger capacity, 65 blocks
Remarks : Because the more capacity of the blocks on the Cold Plate, the faster the process of completing the cut network will be.
Many thanks for this feedback. As this specification is mandatory, the bidder can choose to comply or not. MoH will retain the current specification.
Bidder's suggestion may be restrictive and suggested capacity shall exclude other proposed models/ devices.
Supply Requirements Evaluation Process Qualification Requirements
108 2024-11-14 Row Number : 85
Existing Spec : Up to ±1 °C
Proposed Spec: Proposed change to Orange criteria
Remarks : Only the drastic change of temperature will affects the floating tissue
Many thanks for this feedback. As this specification is mandatory, the bidder can choose to comply or not. MoH will retain the current specification.
The set value and crucial parameter permits a key capability of the device to maintain the temperature.
Supply Requirements Evaluation Process Qualification Requirements
109 2024-11-14 Row Number : 202
Existing Spec :Liquid Sanitizer
Proposed Spec:How many samples for 365 days?
Remarks :
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications.
Amended to Preferred; Bidder to supply a quantity of 100 tests
Supply Requirements Evaluation Process Qualification Requirements
110 2024-11-14 Row Number : 169 Existing Spec : Holding rod
Proposed Spec:
Remarks : Not applicable in pathology anatomy laboratory
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications.
Agreeable to the bidder's suggestion to amend to preferred.
Supply Requirements Evaluation Process Qualification Requirements
111 2024-11-14 We are writing to seek additional clarification on the following questions, pursuant to Instructions to Bidder (ITB 7.1) of the bidding documents.
Please find our questions by the official letter attached.
Thank you for the opportunity to submit our clarifications and we look forward to receiving your feedback.
1. On your response to the clarification question on the Ventilator tender last August 20, the procurement committee confirmed that submitting the Cybersecurity Certificate from the bidder’s overseas principal, who is the OEM of the products, is allowed. The bidder is also requested to provide their MDS2 Forms. In following this advice from the procurement team, we request the Ministry of Health to amend the language on the Cybersecurity accreditation requirement for tenders moving forward. Whereas bidders will be allowed to submit the ISO 27000 or ISO 27001 from the bidder’s principal OEM such that:
“ITB 32.1, (e): The bidder or the bidder’s OEM supplier has experience in managing cyber security, practice and track record, including relevant
Cyber security accreditation such as ISO 27000 (ISO 27001) or equivalent”
Yes, it is allowed. Other Unrelated Questions Unrelated Questions
112 2024-11-14 Row Number : 206
Existing Spec : High pH Antigen Retrieval Solution
Proposed Spec:How many samples for 365 days?
Remarks :
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications.
Amended to Preferred; Bidder to supply a quantity of 100 tests
Supply Requirements Evaluation Process Qualification Requirements
113 2024-11-14 Row Number : 65
Existing Spec : Display Temperature Scale Proposed Spec: Proposed change to Orange criteria
Remarks : Because the temperature for immunohistochemistry has already recommended at default setting, so it is not mandatory to display the scale
Many thanks for this feedback. As this specification is mandatory, the bidder can choose to comply or not. MoH will retain the current specification.
Temperature display is a key parameter of a hotplate that should be displayed for monitoring and safety purposes.
Supply Requirements Evaluation Process Qualification Requirements
114 2024-11-14 Row Number : 76 Existing Spec : 150 watts
Proposed Spec: Proposed to change as general spec, like 100-300 watts
Remarks : High voltage is needed to speed up the cooling process of the slide block.
Many thanks for this feedback. As this specification is mandatory, the bidder can choose to comply or not. MoH will retain the current specification.
Bidder's suggestion may be restrictive and suggested capacity shall exclude higher end models other proposed models/ devices.
Supply Requirements Evaluation Process Qualification Requirements
115 2024-11-14 Row Number : 35 Existing Spec :360°
Proposed Spec: Proposed change to Orange criteria
Remarks : Leads to one or a particular brand of product (Slee Cut 6062, Diapath Semi Automatic)
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications. Supply Requirements Evaluation Process Qualification Requirements
116 2024-11-14 3. For the IHK Set Accessories, could you please clarify the specific requirements for the "Rapid Diagnosis Assay"?
Our device is an auto stainer, and we would like to understand precisely what type of RDA is needed.
An automated immunohistochemistry (IHC) stainer is a sophisticated laboratory instrument used in histopathology and medical diagnostics to automate and standardize the process of applying specific antibodies to tissue sections on microscope slides. The Capsule with an attached tag (used for identification) is inserted into a reusable plastic Reagent Dispensing Area (RDA) and the RDA is loaded onto any of the available 30 independent staining stations along with the slide, provides an added feature to this device. More than 3 vendors can comply to this added feature.
Rapid diagnostic assays in IHC stainers refer to optimized, automated workflows and pre- validated protocols that enable fast and efficient staining, reducing turnaround times while ensuring high-quality, consistent diagnostic results. These systems support parallel processing, ready-to-use reagents, and continuous workflows for streamlined lab operations.
Bidding Procedure Evaluation Process Evaluation Criteria
117 2024-11-14 Dear Procurement Committee 4:
We are writing to seek additional clarification on the following questions, pursuant to Instructions to Bidder (ITB 7.1) of the bidding documents: QUESTION 1
Manufacturing Experience and Technical Capacity Page 55
Manufacturing experience and Technical Capacity: For the items under the Contract that the bidder is a manufacturer, the Bidder shall furnish documentary evidence to demonstrate that:
• it has manufactured IHK Set equipment for at least seven (7) years, prior to the bid submission deadline; and
• its annual production capacity of IHK Set equipment for each of the last seven
(7) years prior to the bid submission deadline, is at least 50% the quantities specified under each lot.
The requirement stating that a company is eligible to participate only if it demonstrates having produced a quantity of each requested instrument equal to 50% of the total required for each lot cannot be met by the majority of diagnostic pre-analytical instrument manufacturers. Each company is more or less specialized and successful in specific instruments, and we believe that the required figures favor only the two largest companies in the market, despite many others being fully capable of ensuring adequate production capacity to meet the demands of all tender lots.
Trusting in the tender committee’s intention to extend competition to as many companies as possible, we request a review of this requirement and propose the following alternatives:
1. A total revenue from pre-analytical products equal to or exceeding at least
$10 million over the past seven years;
2. A total production of pre-analytical instruments equal to 50% of the quantities required in the tender lots.
Please refer to the respective response on the question #20. Bidding Procedure Evaluation Process Qualification Requirements
118 2024-11-14 Row Number : 161
Existing Spec : Section Transfer System STS Proposed Spec:
Remarks : Section Transfer System™(STS) is a Trade Mark from Epredia.
Not required because already has the Tissue Floating Bath or Water Bath, This process can be done in a tissue floating bath/water bath.
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications.
Agreeable to the bidder's suggestion to remove the specification.
Supply Requirements Evaluation Process Qualification Requirements
119 2024-11-14 Row Number : 42
Existing Spec : 10 - 30 µm
Proposed Spec: Proposed change as general spec, example 1 - 600 μm Remarks :
Many thanks for this feedback. As this specification is mandatory, the bidder can choose to comply or not. MoH will retain the current specification.
1-600 μm range is a preferred range; minimum range maintains as mandatory and the higher range is kept as preferred.
Supply Requirements Evaluation Process Qualification Requirements
120 2024-11-14 Row Number : 180
Existing Spec : Stainless steel sloping lid for SAPXX
Proposed Spec:
Remarks : Not applicable in pathology anatomy laboratory
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications.
Agreeable to the bidder's suggestion to remove the specification.
Supply Requirements Evaluation Process Qualification Requirements
121 2024-11-14 Row Number : 168
Existing Spec : Boss head clamp
Proposed Spec:
Remarks : Not applicable in pathology anatomy laboratory
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications.
Agreeable to the bidder's suggestion to amend to preferred.
Supply Requirements Evaluation Process Qualification Requirements
122 2024-11-14 Row Number : 205
Existing Spec : Citrate Antigen Retrieval Solution
Proposed Spec:How many samples for 365 days?
Remarks :
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications.
Amended to Preferred; Bidder to supply a quantity of 100 tests
Supply Requirements Evaluation Process Qualification Requirements
123 2024-11-14 Row Number : 207
Existing Spec : Wash Buffer
Proposed Spec:How many samples for 365 days?
Remarks :
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications.
Amended to Preferred; Bidder to supply a quantity of 100 tests
Supply Requirements Evaluation Process Qualification Requirements
124 2024-11-14 Row Number : 170
Existing Spec : Vertical support rod
Proposed Spec:
Remarks : Not applicable in pathology anatomy laboratory
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications.
Agreeable to the bidder's suggestion to amend to preferred.
Supply Requirements Evaluation Process Qualification Requirements
125 2024-11-14 Row Number : 183
Existing Spec :Rack for Tubes
Proposed Spec:
Remarks : Not applicable in pathology anatomy laboratory
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications.
Agreeable to the bidder's suggestion to remove the specification.
Supply Requirements Evaluation Process Qualification Requirements
126 2024-11-14 Row Number : 181
Existing Spec : Flat lid with 2 ring sets for SAPXX
Proposed Spec:
Remarks : Not applicable in pathology anatomy laboratory
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications.
Agreeable to the bidder's suggestion to remove the specification.
Supply Requirements Evaluation Process Qualification Requirements
127 2024-11-14 Row Number : 142 Existing Spec : 1 to ≥ 20
Proposed Spec: Proposed to bigger capacity, 36
Remarks : The large capacity of the reagent container will make it easier to carry out the multi-antibody analysis process.
Many thanks for this feedback. As this specification is mandatory, the bidder can choose to comply or not. MoH will retain the current specification.
The setting is set at a minimum of 20 to remain as a neutral tech specs.
Supply Requirements Evaluation Process Qualification Requirements
128 2024-11-14 Row Number : 159
Existing Spec : Slide Printer
Proposed Spec:
Remarks : Slide printers are usually set separately
Many thanks for this feedback. As this specification is mandatory, the bidder can choose to comply or not. MoH will retain the current specification.
This provides an additional feature to remain as a neutral tech spec.
Supply Requirements Evaluation Process Qualification Requirements
129 2024-11-14 Row Number : 84
Existing Spec : Ambient +5°C to 100°C
Proposed Spec: Propose change to general spec, 15 °C to 45°C Remarks : the higher temperature (up to 100 °C) can damage the tissue
Many thanks for this feedback. As this specification is mandatory, the bidder can choose to comply or not. MoH will retain the current specification.
Bidder's suggestion may be restrictive and suggested minimum lower temperature range shall exclude other proposed models/ devices.
Supply Requirements Evaluation Process Qualification Requirements
130 2024-11-14 Row Number : 200
Existing Spec : How many samples for 365 days?
Proposed Spec:
Remarks :
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications.
Amended to Preferred; Bidder to supply a quantity of 100 tests
Supply Requirements Evaluation Process Qualification Requirements
131 2024-11-14 Row Number : 178
Existing Spec : Raised shelf
Proposed Spec:
Remarks : Raised shelf is not common used in the specs, it usually salled as detachable tray
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications.
Agreeable to the bidder's suggestion to amend to preferred.
Supply Requirements Evaluation Process Qualification Requirements
132 2024-11-14 Row Number : 204
Existing Spec : Dewax Solution
Proposed Spec:How many samples for 365 days?
Remarks :
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications.
Amended to Preferred; Bidder to supply a quantity of 100 tests
Supply Requirements Evaluation Process Qualification Requirements
133 2024-11-14 Row Number : 166
Existing Spec : External temperature controller
Proposed Spec:
Remarks : Not applicable in pathology anatomy laboratory
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications.
Agreeable to the bidder's suggestion to remove the specification.
Supply Requirements Evaluation Process Qualification Requirements
134 2024-11-14 Row Number : 179 Existing Spec :
Proposed Spec:
Remarks : Not applicable in pathology anatomy laboratory
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications.
Agreeable to the bidder's suggestion to amend to preferred.
Supply Requirements Evaluation Process Qualification Requirements
135 2024-11-14 Row Number : 182
Existing Spec :Base Tray for SAPXX
Proposed Spec:
Remarks : Not applicable in pathology anatomy laboratory
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications.
Agreeable to the bidder's suggestion to remove the specification.
Supply Requirements Evaluation Process Qualification Requirements
136 2024-11-14 2. Additionally, could you please provide an example or further details regarding SPAXX? Bidder to advice which specific row that requires more clarification. However it has been answered in the above clarifications. Other Unrelated Questions Unrelated Questions
137 2024-11-14 Row Number : 63
Existing Spec : Ambient to ≤ 540°C
Proposed Spec: Propose change to general spec, which is up to 75℃ Remarks : Because if up to 100°C, can damage tissue sample
Many thanks for this feedback. As this specification is mandatory, the bidder can choose to comply or not. MoH will retain the current specification.
The range indicates the maximum heating capability of the equipment which is an inclusive value.
Supply Requirements Evaluation Process Qualification Requirements
138 2024-11-14 Row Number : 126
Existing Spec : Anti-HER2/neu
Proposed Spec: Proposed change to Anti-Her2 only as a general
Remarks : Leads to one or a particular brand of product (Anti-HER/neu isTrade Mark from Roche)
Many thanks for this feedback. As this specification is rated criteria, the bidder can choose to comply or not. MoH will retain the current specification.
A tissue test to check on certain protein in cell growth (HER2/neu) that is presented in 20% in certain types of cancer cells; additional features in testing.
Supply Requirements Evaluation Process Qualification Requirements
139 2024-11-14 Row Number : 164
Existing Spec : Optical Accessories
Proposed Spec: Proposed change to Orange criteria
Remarks : Not all the tissue need the optical accessoriss, general microtome does'nt need this, and it usually come separately
Many thanks for this feedback. As this specification is mandatory, the bidder can choose to comply or not. MoH will retain the current specification.
Optical accessories describes Large Field Magnifier, Zoom-Stereomicroscope. It is a preferred specification.
Supply Requirements Evaluation Process Qualification Requirements
140 2024-11-14 Row Number : RFB ITB.41
Existing Spec : Maximum number of members in the Joint Venture (JV) shall be maximum three (3)
Proposed Spec: Maximum number of members in the Joint Venture (JV) shall be maximum four (4)
Remarks :
Thank you for your question. Regarding the RFB Document, Maximum number of members in the JV shall be three (3). There is specific minimum percentage of participation outlined in the bidding document, but it is crucial that every member’s role is clearly defined and substantial enough to demonstrate their active involvement in the contract execution. This must be reflected in the joint venture agreement and the bid submission, ensuring all members are equally responsible and accountable for the success of the project. Bidding Procedure Procurement Regulations Eligible Bidders (including joint venture)
141 2024-11-14 Row Number : 68 Existing Spec : Ceramic
Proposed Spec: Proposed to change the spec to alumunium Remarks : Not required because it is not applicable in the
immunohistochemistry. Most of the type for chemical laboratory use with
the stirer
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications.
Ceramic, is a material (without proprietary trademark), has an advantage over aluminium hot plate material i.e., uniForms heat distribution, higher temperature resistance, superior chemical resistance, greater durability, easier cleaning, excellent electrical insulation, inert surface, and enhanced visibility.
The specification is amended to be preferred.
Supply Requirements Evaluation Process Qualification Requirements
142 2024-11-14 Good morning, Mr./Ms. Procurement Committee IHK Set,
We are writing from PT XXXX to inquire about a few matters as follows:
1. In the Accessories and Consumables section, we noticed a few items that, in our view, seem to restrict specifications. One example is the Microtome. While we meet the required specifications, the Accessories require an STS (Section Transfer System), which we do not have.
We kindly ask for your consideration to mark it as a "preferred" item or highlight it in yellow or white so that we may also offer our product, given that it already meets the necessary specifications.
Thank you for your attention and consideration.
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications. Other Unrelated Questions Unrelated Questions
143 2024-11-14 Row Number : 117
Existing Spec : 25 x 75 mm to 26 x 76 mm
Proposed Spec: "Propose to general spec, Width: 24.64–26.0 mm (0.97– 1.02 in)
Length: 74.9–76.0 mm (2.95–2.99 in)"
Remarks : Leads to one or a particular brand of product - Roche
Many thanks for this feedback. As this specification is mandatory, the bidder can choose to comply or not. MoH will retain the current specification. Supply Requirements Evaluation Process Qualification Requirements
144 2024-11-14 QUESTION 2
Request to provide purchase contract, purchase order or installation reports signed by the end users to prove the experience in supplying and to install the requested equipment.
Page 55
With reference to this request, we would like to highlight the impossibility for the majority of pre analytical companies to retrieve such documents. All pre-analytical companies, except XXX, operate through local distributors in the various markets where they are active. Consequently, these documents are managed by the distributors themselves and are not directly held by the original manufacturer.
In addition to this issue, another barrier to retrieving such documents is the data privacy and sensitive inFormsation protection laws in force in Europe, the United States, and certain Asian countries, including China. These regulations do not allow for the free circulation of such documents without prior authorization from the parties involved—the distributor and the end customer. Obtaining such consent, as well as translating all documents into English, is extremely complex and prohibitive within the tender deadlines.
Lastly, among the instruments covered by this request are the refrigerator, hot plate, and water bath. Regarding the refrigerator, no company specializing in IVD products manufactures or resells such a product; therefore, it is impossible for companies to obtain the required documents. The hot plate and water bath, on the other hand, are extremely basic instruments that often require no specific installation beyond plugging them in. They are frequently purchased through inFormsal, untracked orders due to their low value.
We believe that if the refrigerator remains on the list, the tender will result in no participants. If the refrigerator is excluded but these document requirements remain for the other instruments, only one company will be able to provide the requested documentation. This will result in a tender with low competition and a significant risk of not awarding the contract due to a lack of bids. Therefore, we propose the following alternatives, which we believe are more appropriate for demonstrating the experience of participating companies:
1. Accepting the purchase order issued by the distributor to the manufacturing company as proof. Distributors do not issue purchase orders unless they have received a notification of award from a tender or a purchase order from the end customer. Therefore, we believe that this document is sufficient to demonstrate the manufacturer's actual experience in such operations.
2. A reference list prepared by the manufacturing company, with at least 10 reference customers listed per product, including the final customers’ name, email address, and phone number, allowing the tender committee to gather inFormsation about the manufacturer's experience and the quality of services provided.
3. To not consider the refrigerator in this list
4. To not consider the water bath and hot plate in this list since these equipment are extremely simple and do not require any special experience to be installed or manufactured. Keeping them in the list will only lead to a lower competition and raise barriers for many established companies without a reasonable and valuable advantage for the purchaser.
We look forward for your positive answers, Sincerely,
Thank you for your question. We have revise the requirement as follows:
Based on the RFB, the bidder must be able to demonstrate experience in supplying and installing Microtomes annually in any one year and Automatic Immunohistochemistry Stainers annually in any one year within the last seven
(7) years. As the Microtomes and Automatic Immunohistochemistry Stainers is the most sophisticated component and represents the largest part of the cost, it will be considered as the key element of the bidder's experience. For a joint venture, this requirement may be met by all members combined. Maximum number of members in the JV shall be three (3). There is specific minimum percentage of participation outlined in the bidding document, but it is crucial that every member’s role is clearly defined and substantial enough to demonstrate their active involvement in the contract execution. In case bidder wants to submit PO/DO instead of contract page, the bidder still need to demontrate the experience not only delivery part, but also shows experience on the related services (installation). Please refer to 2nd Amendment IHK Set Package issued on 18-12-2024.
Other Unrelated Questions Unrelated Questions
145 2024-11-14 Row Number : 24
Existing Spec : Single, Interval, Multiple, Continuous
Proposed Spec: Single, Interval, Multiple, Continuous, Rock, Step, Program Remarks : Rock mode - with activated retraction
Many thanks for this feedback. As this specification is mandatory, the bidder can choose to comply or not. MoH will retain the current specification.
The cutting modes are generic modes that are available in most equipment, catering for specific IHC procedures, tissue type being analysed, and goals of the experiment (such as focusing on a particular protein expression or examining the overall tissue architecture).
Supply Requirements Evaluation Process Qualification Requirements
146 2024-11-15 For the manufacturer's experience, we kindly request it to be set at 5 years, considering that the equipment specified involves advanced technology, and many manufacturers have only started production within the past 5 years. Please refer to the respective response on the question #20. Bidding Procedure Evaluation Process Evaluation Criteria
147 2024-11-15 If we, as a bidder, wish to participate in all lots (Lot 1 to Lot 4), should the minimum specific experience and the Manufacturer's production capacity outlined in the RFB document be cumulative (combined total of 150 units for Lots 1-4), or should it only align with the requirements of each individual lot? If possible, we suggest that these requirements not be cumulative so that more vendors can participate. Please refer to the respective response on the question #18. Other Unrelated Questions Unrelated Questions
148 2024-11-15 We plan to Forms a joint venture with the manufacturer of the equipment. Will the minimum specific installation experience still be required? If possible, we suggest allowing the use of only the manufacturer's production capacity. Please refer to the respective response on the question #19. Bidding Procedure Procurement Regulations Eligible Bidders (including joint venture)
149 2024-11-15 To accommodate the numerous questions and suggestions from various vendors, we kindly request that the submission deadline for the documents be extended until January 2025. Please refer to the respective response on the question #22. Other Unrelated Questions Unrelated Questions
150 2024-11-15 For the Minimum Specific Experience and the Manufacturer's Production Capacity, we kindly request that it not be made mandatory as a SET. This is highly challenging and burdensome for us as a bidder since each equipment type is different, with different manufacturers, separate usage, and independent sales. If the experience must be set as a SET, we suggest allowing the joint venture to include up to 6 members or requiring experience for only one primary piece of equipment, namely the Automatic Immunohistochemistry Stainer. Thank you for your question. We have revise the requirement as follows:
Based on the RFB, the bidder must be able to demonstrate experience in supplying and installing Microtomes annually in any one year and Automatic Immunohistochemistry Stainers annually in any one year within the last seven
(7) years. As the Microtomes and Automatic Immunohistochemistry Stainers is the most sophisticated component and represents the largest part of the cost, it will be considered as the key element of the bidder's experience. For a joint venture, this requirement may be met by all members combined. Maximum number of members in the JV shall be three (3). There is specific minimum percentage of participation outlined in the bidding document, but it is crucial that every member’s role is clearly defined and substantial enough to demonstrate their active involvement in the contract execution. In case bidder wants to submit PO/DO instead of contract page, the bidder still need to demontrate the experience not only delivery part, but also shows experience on the related services (installation). Please refer to 2nd Amendment IHK Set
Package issued on 18-12-2024.
Supply Requirements Evaluation Process Specific Experience
151 2024-11-15 Regarding the importation procedure for the equipment, if the holder of the distribution permit is not a member of the JV, is it possible? What would be the mechanism if they were to become the winner? Please refer to the respective response on the question #21. Bidding Procedure Evaluation Process Evaluation Criteria
152 2024-11-18 Reference:
Specific Experience
Pre-bid meeting on Nov 7, 2024
Request and Clarification:
Based on MoH's feedback during the pre-bid meeting last Nov 7, 2024, we would like to confirm that that bidders may use deliveries/installations done through distributors provided that it supported with the appointment letter to the distributor and supported by the PO/DO to the distributor.
Please refer to the respective response on the question #2. Bidding Procedure Evaluation Process Specific Experience
153 2024-11-18 Dear sir/madam,
May I clarify the following requirements For the tender?
1. bidder has to provide the installation record. Is it in total 150 installation for all 4 lots or bidder need to provide the maximum 33 installations record for individual lot?
Regarding the RFB Document, the Bidder must demonstrate that it has successfully and substantially completed similar Goods and Related Services (installation) for the IHK Set. A total of 150 units is the minimum cumulative number of units in any year within the last 7 years (Lot 1-4). For the minimum cumulative requirements for each Lot, please refer to the RFB Document (Section III. Evaluation and Qualification Criteria, Technical Part, 1.
Qualification, b. Specific Experience, Page 54).
Bidding Procedure Evaluation Process Specific Experience
154 2024-11-18 Reference:
Contract Amount for Past Experience Documentary Evidence for Specific Experience
(b) under Section III - Evaluation and Qualification Criteria Page 54
Request and Clarification:
As proof of compliance to the specific experience requirements, the bid document requires bidders to furnish detailed inFormsation regarding contracts completed, including past contract amount.
We would like to respectfully request the procurement committee to allow bidders not to provide the past contract amount for contracts outside Indonesia. Contracts with institutions outside Indonesia follow strict data privacy laws that make it a challenge for us to meet this requirement. While our customers from outside Indonesia agree to serve as a reference site which can be called and interviewed for their experience with our instrument, they do not want to share their contract values and we need to comply to data privacy requirements
We believe this will not affect the bid evaluation because the experience requirements focus on the number of units installed and not the corresponding contract value. Furthermore, prices strongly vary between countries and contexts and also depend on the distribution model. Therefore, values from contracts in other countries may not be representative for Indonesia
We will supply all the other required documents, including copies of relevant pages of Purchase Orders and Delivery Orders especially highlighting the number of units supplied and installed as sufficient verifiable proof to satisfy the Minimum Specific Experience requirement stated on pages 54-55.
Please refer to the respective response on the question #2. Bidding Procedure Evaluation Process Specific Experience
155 2024-11-18 3. row 204 to 208 ( bidder to supply for 365 days) of consumables - this specification states to provide reagent for 356 days. Please advise this speicifcation need to provide 356 days quantity of each reagent or jsut need to state as compy.
Related to this speicfication, In propose consumbales tab, provide total consumables for 100 typical patients. as each patient IHC needs will be different. eg Breast cancer, there may have about 4 antibodies as such each patient will use 4 tests and total of 400 tests.
However, another type of cancer will have different sets of antibodies and may have varying tests. Kinldy advise how this quanitiy of consumables to be calculated, or 100 patients means 100 tests ( 100 slides)? kinldy clarify.
Many thanks.
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications.
Amended to Preferred; Bidder to supply a quantity of 100 tests
Supply Requirements Evaluation Process Qualification Requirements
156 2024-11-18 Reference:
Technical Specification Excel Spreadsheet, Row 191 on RDA-Tags
Request and Clarification:
Row 191 on RDA-Tags
We respectfully request to remove this specification, since it can only be met by one vendor.
Many thanks for this feedback. As this specification is rated criteria, the bidder can choose to comply or not. MoH will retain the current specification.
An automated immunohistochemistry (IHC) stainer is a sophisticated laboratory instrument used in histopathology and medical diagnostics to automate and standardize the process of applying specific antibodies to tissue sections on microscope slides. The Capsule with an attached tag (used for identification) is inserted into a reusable plastic Reagent Dispensing Area (RDA) and the RDA is loaded onto any of the available 30 independent staining stations along with the slide, provides an added feature to this device. More than 3 vendors can comply to this added feature.
Rapid diagnostic assays in IHC stainers refer to optimized, automated workflows and pre- validated protocols that enable fast and efficient staining, reducing turnaround times while ensuring high-quality, consistent diagnostic results. These systems support parallel processing, ready-to-use reagents, and continuous workflows for streamlined lab operations.
Supply Requirements Evaluation Process Qualification Requirements
157 2024-11-18 Reference in Bidding Document:
RFB Page 54: Section III – Evaluation and Qualification Criteria
The Bidders shall have past contract experience to supply and install IHK Set equipment of minimum cumulative 55 unit annually in any of year within the last seven (7) years prior to bid submission deadline.
Clarification/Question:
Regarding the bidder qualifications, the document states that proof of supply and installation experience over the past 7 years is required. If the bidder is the manufacturer, is it acceptable to use contracts between the manufacturer and the distributor to demonstrate this experience?
Alternatively, would it be permissible to use, with authorization to the distributor, contracts between the distributor and the end user to prove the required experience?
Thank you for your question. We have revise the requirement as follows:
Based on the RFB, the bidder must be able to demonstrate experience in supplying and installing Microtomes annually in any one year and Automatic Immunohistochemistry Stainers annually in any one year within the last seven
(7) years. As the Microtomes and Automatic Immunohistochemistry Stainers is the most sophisticated component and represents the largest part of the cost, it will be considered as the key element of the bidder's experience. For a joint venture, this requirement may be met by all members combined. Maximum number of members in the JV shall be three (3). There is specific minimum percentage of participation outlined in the bidding document, but it is crucial that every member’s role is clearly defined and substantial enough to demonstrate their active involvement in the contract execution. In case bidder wants to submit PO/DO instead of contract page, the bidder still need to demontrate the experience not only delivery part, but also shows experience on the related services (installation). Please refer to 2nd Amendment IHK Set
Package issued on 18-12-2024.
Bidding Procedure Evaluation Process Specific Experience
158 2024-11-18 2. If the bidder is the local distributor and it does not have enough installation experience in Indonesia, can the manufacturer authorise the installation record for region/country level to local distributor as a justification, is it acceptable?
Thank you.
Regards,
The required experience is supply and installation of similar medical equipment in all regions (there is no specific region). If the bidder (manufacturer)'s past experience was in the Forms of joint venture with the firm who carried out installation, then such experience can be considered. Bidders (firms) may Forms a joint venture with other firms to enhance their qualificaiton and only qualification of the bidder will be evaluated. Please refer to ITB 32.2 which stipulates that the determination of Bidder's qualification shall not take into consideration the qualifications of other firms such as the Bidder’s subsidiaries, parent entities, affiliates, subcontractors, or any other firm different from the Bidder. Supply Requirements Evaluation Process Specific Experience
159 2024-11-18 Reference:
Row 6: Preparation of “bare room”
lnstallation Activities in the Technical Specifications Spreadsheet
Request and Clarification:
We would like to clarify if 100% of the beneficiary hospitals will provide a “bare room” for the IHK Set or will there be a percentage of hospitals that might have furnished or painted rooms? Based on the list of locations provided in the bid document, they might already have pre-existing laboratories where IHK Set can be installed.
Yes, the beneficiary hospitals will provide a “bare room” for the IHK Set Supply Requirements Evaluation Process Qualification Requirements
160 2024-11-18 Reference:
Technical Specification Excel Spreadsheet, row 194 on Storage and Transport Trays
Request and Clarification:
Row 194 on Storage and Transport Trays
We respectfully request to remove this specification, since it can only be met by one vendor.
Many thanks for this feedback. As this specification is rated criteria, the bidder can choose to comply or not. MoH will retain the current specification.
This provides an additional feature to remain as a neutral tech spec.
Supply Requirements Evaluation Process Qualification Requirements
161 2024-11-18 Reference:
Technical Specification Excel Spreadsheet, row 190 on RDA (Rapid Diagnostic Assay)
Request and Clarification:
Row 190 on RDA (Rapid Diagnostic Assay)
We respectfully request to remove this specification, since it can only be met by one vendor.
Many thanks for this feedback. As this specification is rated criteria, the bidder can choose to comply or not. MoH will retain the current specification.
An automated immunohistochemistry (IHC) stainer is a sophisticated laboratory instrument used in histopathology and medical diagnostics to automate and standardize the process of applying specific antibodies to tissue sections on microscope slides. The Capsule with an attached tag (used for identification) is inserted into a reusable plastic Reagent Dispensing Area (RDA) and the RDA is loaded onto any of the available 30 independent staining stations along with the slide, provides an added feature to this device. More than 3 vendors can comply to this added feature.
Rapid diagnostic assays in IHC stainers refer to optimized, automated workflows and pre- validated protocols that enable fast and efficient staining, reducing turnaround times while ensuring high-quality, consistent diagnostic results. These systems support parallel processing, ready-to-use reagents, and continuous workflows for streamlined lab operations.
Supply Requirements Evaluation Process Qualification Requirements
162 2024-11-18 Reference:
Technical Specification Excel Spreadsheet, row 103 on Temperature Range Refrigerator
Request and Clarification:
Row 103 on Temperature Range Refrigerator We would like to request for the MOH to amend the Temperature Range of the Refrigerator to 2°C to 8° C.
All IHC antibodies should be stored 2°C to 8°C. If the antibodies are stored at temperature above 8°C, the antibodies will be damaged and cannot be used for testing (quality concern). This can result to false positive or false
negative in the patient result
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications.
Agreeable to the bidder's suggestion to the range of to 2°C to 8°C.
Supply Requirements Evaluation Process Qualification Requirements
163 2024-11-18 Reference:
Technical Specification Excel Spreadsheet, row 122 on Anti- CD20
Request and Clarification:
Row 122 on Anti- CD20 We would like to request this specification be changed to mandatory (green criteria) instead of preferred (orange criteria). This is aligned with the MoH’s policies (Minister of Health Decree HK01.
03/MENKES/6485/2021 and Regulation No. 3 of 2023) mandate that specifies parameters, including the CD-20 parameter, which must be tested prior to treatment.
Since this test is covered by the National Health Insurance, availability of such application will encourage a more accurate and earlier diagnosis
which aligns with the national health objectives set by MOH.
Many thanks for this feedback. As this specification is rated criteria, the bidder can choose to comply or not. MoH will retain the current specification.
This provides an additional feature to remain as a neutral tech spec.
Supply Requirements Evaluation Process Qualification Requirements
164 2024-11-18 2. line 190, 191, 192 - RDA ( rapid diagnsotic Assay) - as in IHC process our understanding that the staining process can be continuous loading for histology slides, when there is urgent case. May i confrim this RSA refers to this continuous loading of slides? if not, kinldy elaborate this three specifications. Many thanks for this feedback. The bidder can choose to comply or not. MoH will retain the current specification.
An automated immunohistochemistry (IHC) stainer is a sophisticated laboratory instrument used in histopathology and medical diagnostics to automate and standardize the process of applying specific antibodies to tissue sections on microscope slides. The Capsule with an attached tag (used for identification) is inserted into a reusable plastic Reagent Dispensing Area (RDA) and the RDA is loaded onto any of the available 30 independent staining stations along with the slide, provides an added feature to this device. More than 3 vendors can comply to this added feature.
Rapid diagnostic assays in IHC stainers refer to optimized, automated workflows and pre- validated protocols that enable fast and efficient staining, reducing turnaround times while ensuring high-quality, consistent diagnostic results. These systems support parallel processing, ready-to-use reagents, and continuous workflows for streamlined lab operations.
Supply Requirements Evaluation Process Qualification Requirements
165 2024-11-18 Reference:
Technical Specification Excel Spreadsheet, row 193 on RDA-Tag Label Kit
Request and Clarification:
Row 193 on RDA-Tag Label Kit
We respectfully request to remove this specification, since it can only be met by one vendor.
Many thanks for this feedback. As this specification is rated criteria, the bidder can choose to comply or not. MoH will retain the current specification.
An automated immunohistochemistry (IHC) stainer is a sophisticated laboratory instrument used in histopathology and medical diagnostics to automate and standardize the process of applying specific antibodies to tissue sections on microscope slides. The Capsule with an attached tag (used for identification) is inserted into a reusable plastic Reagent Dispensing Area (RDA) and the RDA is loaded onto any of the available 30 independent staining stations along with the slide, provides an added feature to this device. More than 3 vendors can comply to this added feature.
Rapid diagnostic assays in IHC stainers refer to optimized, automated workflows and pre- validated protocols that enable fast and efficient staining, reducing turnaround times while ensuring high-quality, consistent diagnostic results. These systems support parallel processing, ready-to-use reagents, and continuous workflows for streamlined lab operations.
Supply Requirements Evaluation Process Qualification Requirements
166 2024-11-18 Reference:
Technical Specification Excel Spreadsheet, row 126 on AntiHER2/neu
Request and Clarification:
Row 126 on Anti-HER2/neu We would like to request this specification be changed to mandatory (green criteria) instead of preferred (orange criteria). This is aligned with the MoH’s policies (Minister of Health Decree HK01.03/MENKES/6485/2021 and Regulation No. 3 of 2023) mandate that specifies parameters, including the Anti-HER2/neu parameter, which must be tested prior to treatment.
Since this test is covered by the National Health Insurance, availability of such application will encourage a more accurate and earlier diagnosis,
which aligns with the national health objectives set by MOH.
Many thanks for this feedback. As this specification is rated criteria, the bidder can choose to comply or not. MoH will retain the current specification.
This provides an additional feature to remain as a neutral tech spec.
Supply Requirements Evaluation Process Qualification Requirements
167 2024-11-18 Reference:
Advance Payment Guarantee Page 159 GCC16
Request and Clarification:
According to the Advance Payment Security (Demand Guarantee) Template on Page 179 of the RFB, the maximum amount of this guarantee shall be progressively reduced by the amount of the advance payment repaid by the Supplier as specified in copies of interim statements or payment certificates which shall be presented to MOH.
Given the above, may we request that the MOH can issue a letter to the supplier and the bank issuing the bank guarantee to confirm the reduced amount every quarter?
Thank you for your question. Any specific condition for the advance payment repayment will be explicitly disclosed in the special condition of the contract Contract Contract Management Warranty
168 2024-11-18 Reference:
PerFormsance Security Page 161 GCC 18
Request and Clarification:
We would like to request if the MOH can issue a letter to the supplier and the bank issuing the perFormsance security/bank guarantee to acknowledge the corresponding reduction on the perFormsance security amount towards the end of Year 5 (or start of Year 6) based on the remaining equipment still under the warranty?
For example, when a supplier delivers and fully commissions 100 units on Year 1, the same units will end warranty on Year 5, while a second batch of 50 units commissioned on Year 2 will end warranty on Year 6. In such case, the remaining equipment under warranty will decrease from 150 from year 5 to 50 on Year 6.
Thank you for your question. Any specific condition for the perFormsance security repayment will be explicitly disclosed in the special condition of the contract Contract Contract Management Warranty
169 2024-11-18 Reference in Bidding Document:
Technical specification
Row 143: Cartridge Capacity On-board
Clarification/Question:
In the list of requirements for the Automatic Immunohistochemistry Stainer, What does “cartridge” refer to, and how does it differ from reagent bottles?
Some devices have reagent bottles and some are capable of processing cartridges. This specification is set for inFormsation only (white colour tech specs). Supply Requirements Evaluation Process Qualification Requirements
170 2024-11-18 Reference:
Technical Specification Excel Spreadsheet, row 141 on Antibody and Probe Dispensing Options
Request and Clarification:
Row 141 on Antibody and Probe Dispensing Options We respectfully request to expand the multi-dispensing syringe requirement to “multi- dispenser or equivalent” to allow for other equally effective multi-dispenser techniques not nvolving a syringe. The syringe mechanism is unique to one vendor (Sakura) and it should be open to any other multi-dispenser modality with equal perFormsance.
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications.
Agreeable to bidder's suggestion to expand the tech specs. Amended to include various prefilled, User-fillable Capsules/Cartridges, Manual Pipetting, Multi-Dispensing Syringe or equivalent
Supply Requirements Evaluation Process Qualification Requirements
171 2024-11-18 Reference in Bidding Document:
Technical specification
Row 197-208: Disposable blades: Bidder to supply for 365 days of operation
Liquid Sanitizer: Bidder to supply for 365 days of operation Dewax Solution: Bidder to supply for 365 days of operation
Citrate Antigen Retrieval Solution: Bidder to supply for 365 days of operation
High pH Antigen Retrieval Solution: Bidder to supply for 365 days of operation
Wash Buffer: Bidder to supply for 365 days of operation
Clarification/Question:
The document mentions that the bidder must provide consumables for 365 days of operation. Considering that actual needs vary across different hospitals, could you please provide more specific quantities?
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications.
Amended to Preferred; Bidder to supply a quantity of 100 tests
Other Unrelated Questions Unrelated Questions
172 2024-11-18 Reference:
PerFormsance Security and Advance Payment Guarantee
Page 159-161 GCC 16 and 18 in the Special Conditions of the Contract
Request and Clarification:
We would like to clarify if the Bank Guarantee for PerFormsance Security (2.5% for the entire lot) is different from the Bank Guarantee for Advance Payment (10% of ordered batch)?
If yes, this would mean that the Bidder will need to issue two Bank guarantees on Year 1? Is this correct?
Yes correct, Please refer to SCC 18.3. PerFormsance Security shall be in the Forms of a Demand Guarantee, with Section X - Contract Formss showcasing the relevant templates to be completed by the successful bidder. A perFormsance security in the amount of 2.5% of the Unitary Contract Price for each lot will be required until the completion of uptime-based payments for the final batch of equipment to be delivered to their final destination (2 years post- commissioning of the final batch). This will then be replaced by a 10% perFormsance security during the extended warranty period during which the successful bidder provides comprehensive operational support and maintenance, yet this 10% perFormsance security only applies to the Unitary Contract Value of those devices still under extended warranty and O&M arrangements. This value therefore decreases over time, to a zero-sum when no equipment remains under the extended warranty provisions. Please note that the PerFormsance Security must be valid for the entire warranty period and shall be discharged and returned to the Supplier as provided in GCC 18.4.
Please also refer to SCC 18.4 for details. Moreover, the Bank Guarantee is
required to cover payment to be made after the closing date of the Loan.
Contract Contract Management Warranty
173 2024-11-18 Reference:
Technical Specification Excel Spreadsheet, row 147 on MultiDispensing Syringe Capacity
Request and Clarification:
Row 147 on Multi-Dispensing Syringe Capacity
Can you kindly clarify if the multi-dispensing syringe capacity is only for the reagent or antibody?
Many vendor use different volume for different reagent and antibody. For
antibody many vendors use ≥ 0.5 µL volume While for reagent mostly up to 2L volume. The specification of 5 - 30 mL is locking to only 1 vendor.
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications.
Agreeable to the bidder's suggestion to remove the specification.
Supply Requirements Evaluation Process Qualification Requirements
174 2024-11-18 Dear Sir/Madam,
Considering the Bidding Document soliciting tender applications for:
∙ Contract Title : Procurement of IHK Set
∙ RFB Reference No.: KS.01.02/A.VI/6167/2024
We are writing this letter to request a clarification on the following:
Reference in Bidding Document:
Technical Specification “Hot Plate”
Clarification/Question:
In the technical requirements, it is stated that the "Hot Plate" is used for "heating slides to facilitate tissue adhesion or other heat-related processes." This description involves two different functions, which require two separate devices to achieve: one for facilitating tissue adhesion (hereinafter referred to as Device A) and another for other heat- related processes (hereinafter referred to as Device B). Please refer to the images below for Device A and Device B.
The primary function of Device A is for flattening and drying slides, while the primary function of Device B is to accelerate reagent dissolution through heating. According to the specific parameters described, the device mentioned in the document corresponds to Device B, which does not have the functionality for facilitating tissue adhesion. Therefore, we would like to confirm whether the "Hot Plate" refers specifically to Device A, Device B, or another device that integrates both functions.
Bidding Procedure Evaluation Process Qualification Requirements
175 2024-11-18 Reference:
Letter of Oath subject to Boycott Regulations Page 87
Request and Clarification:
In the case of a Joint Venture, are each member required to sign individual Letters of Oath or only one Letter of Oath is required for the JV?
Thank you for your question. Letter of Oath only requested from the Bidder. In case of JV, all members of JV required to sign Letters of Oath. Bidders are welcome to create their own letter. The letter should confirm that the bidder not from or connected to any country or entity subject to the boycott regulations by the Organization of the Islamic Cooperation, the League of Arab States and the African Union. As long as the letter confirms compliance with the boycott requirement, it should be sufficient. Bidding Procedure Procurement Regulations Eligible Bidders (including joint venture)
176 2024-11-18 Dear Procurement Committee 4:
We are writing to seek additional clarification on the following questions, pursuant to Instructions to Bidder (ITB 7.1) of the bidding documents:
Reference:
IHK Set Equipment Automatic IHC Stainer
Request and Clarification:
We respectfully request the MOH to categorize the Automatic lmmunohistochemistry Stainer (Main Analyzer) as the main equipment and categorize other equipment (cold plate, hot plate, microtome, reagent refrigerator, tissue floating bath) as accessories. We strongly believe this is needed to ensure MoH receives more than 1 responsive bid and to allow for the broadest competition possible.
Limited Competition
No single vendor has all 6 instruments as they are not usually sold together. If we exclude the refrigerator only 1 company (Leica) can provide installation of all 5 instruments together. The joint venture approach is not enough to solve the problem because the current list of products requires more than three types of firms to supply all ó components of the IHK Set. Typically, these would be one firm manufacturing the main IHC analyzer (automatic IHC stainer), one or two firms manufacturing the pre-analytic equipment (hot plate, cold plate, microtome, tissue bath), and one firm manufacturing the reagent refrigerator.
In addition to the list of products, the bid also requires a significant volume and the necessary past contract experience. Suppliers will need to Forms joint ventures with parent companies or affiliates to meet the minimum cumulative units, since the number of contracts completed in Indonesia will not be able to meet this requirement. The combination of the (1) significant volume and (2) the specific list of products for the IHK Set will need more than 3 JV members for firms to be able to bid.
Proposed Amendment
We respectfully request the MoH to amend the bid document to categorize on the Automatic lmmunohistochemistry Stainer (Main Analyzer) as the main equipment and categorize other equipment (cold plate, hot plate, microtome, reagent refrigerator, tissue floating bath) as accessories.
The IHC analyzer is the most sophisticated equipment representing over 80% of the cost. Pre-analytics and refrigerators are basic and standard laboratory instruments and are not lVD-labeled. As such, firms manufacturing pre-analytics and refrigerator can work as sub-contractors to large firms manufacturing the main IHC analyzer.
Many thanks for this feedback. As this specification is rated criteria, the bidder can choose to comply or not. MoH will retain the current specification.
Bidders are encouraged to split all components into individual equipment and float to bidders for better control and include various manufacturers and bidders.
Contract Contract Management Contract
177 2024-11-18 Reference:
Technical Specification Excel Spreadsheet, row 195 on Workflow Organizers
Request and Clarification:
Row 195 on Workflow Organizers
We respectfully request to remove this specification, since it can only be met by one vendor.
Many thanks for this feedback. As this specification is rated criteria, the bidder can choose to comply or not. MoH will retain the current specification.
Workflow Organizers are integral components designed to enhance laboratory efficiency and streamline processes. They encompass various tools and accessories that facilitate the organization and management of slides, reagents, and staining protocols.
For example Slide Staining Trays and Racks, Reagent Dispensing Systems, Slide Labelling and Tracking Accessories, Automated Slide Stainers, Waste Management Systems.
Supply Requirements Evaluation Process Qualification Requirements
178 2024-11-18 Reference:
Technical Specification Excel Spreadsheet, row 136 on H&E (Hematoxylin and Eosin)
Request and Clarification:
We strongly recommend replacing H&E with ALK. H&E is a different staining technique from IHC. There is no instrument in the world that can combine H&E and IHC staining in 1 stainer instrument. This staining parameter should be replaced into ALK since based on MoH’s policy (Minister of Health Decree HK01.03/MENKES/6485/2021) mandate, specific parameters including the ALK parameter, must be tested prior to treatment. Therefore, it would be aligned with the utilization in the sites.
Many thanks for this feedback. As this specification is rated criteria, the bidder can choose to comply or not. MoH will retain the current specification.
This provides an additional feature to remain as a neutral tech spec.
Supply Requirements Evaluation Process Qualification Requirements
179 2024-11-18 Dear Sir/ Mdm
Here are some of our additonal inFormsation requested on the tender technical specification requirements for your advice.
1. Row 189 , Water rinse bottle ( bidder required to supply) - this specification set as requirement but some of the systems with new technology doesn't required water rinse. eg Wondfo Biotech IHC system. in that case we will be specify as not required for water rinse. Kinldy advise how this will impact on the scoring specification criteria.
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications.
Agreeable to the bidder's suggestion to remove the specification as does not adversely effect newer models
Supply Requirements Evaluation Process Qualification Requirements
180 2024-11-18 Reference:
Technical Specification Excel Spreadsheet, row 149 on Antibody
Request and Clarification:
Row 149 on Antibody
May we suggest to expand the range of the preferred antibody volume to "100-140µL" in order to expand the number of diseases that the IHC Stainer can test, thereby increasing the costeffectiveness of the IHC Set?
1. The current specification does not allow testing for lung cancer case, which will require a minimum of 100µL, smaller amount required than 140µL
2. Current specification of 140µL can only be met by 1 vendor.
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications.
Agreeable to amend range to "up to 140µL to provide a neutral tech specs.
Supply Requirements Evaluation Process Qualification Requirements
181 2024-11-18 Bidding Procedure Evaluation Process Qualification Requirements
182 2024-11-18 Reference:
Technical Specification Excel Spreadsheet, row 128 on AntiProgesterone Receptor (PR)
Request and Clarification:
Row 128 on Anti-Progesterone Receptor (PR) We would like to request this specification be changed to mandatory (green criteria) instead of preferred (orange criteria) to align with the MoH’s policies (Minister of Health Decree HK01.03/MENKES/6485/2021 and Regulation No. 3 of 2023) and mandate that specifies parameters, including the CD-20 parameter, must be tested prior to treatment.
Since this test is covered by the National Health Insurance, availability of
such application will encourage a more accurate and earlier diagnosis, which aligns with the national health objectives set by MOH.
Many thanks for this feedback. As this specification is rated criteria, the bidder can choose to comply or not. MoH will retain the current specification.
This provides an additional feature to remain as a neutral tech spec.
Supply Requirements Evaluation Process Qualification Requirements
183 2024-11-18 Reference in Bidding Document:
Technical specification
Row 160: Embedding Console System Row 164: Optical Accessories
Clarification/Question:
In the list of required accessories for the microtome, it mentions an "Embedding Console System" and "Optical Accessories." We have found images of similar products. Could you please confirm if they match the ones referenced? If not, could you provide more specific inFormsation regarding what is being referred to?
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications.
Agreeable to the bidder's suggestion to amend accessories as preferred.
Supply Requirements Evaluation Process Qualification Requirements
184 2024-11-18 Bidding Procedure Evaluation Process Qualification Requirements
185 2024-11-18 Reference:
Technical Specification Excel Spreadsheet, row 154 on Remote Diagnostic Functions
Request and Clarification:
Row 154 on Remote Diagnostic Functions
We respectfully request to remove this preferred criteria, since it can only be met by one vendor.
Many thanks for this feedback. As this specification is rated criteria, the bidder can choose to comply or not. MoH will retain the current specification.
This provides an additional feature to remain as a neutral tech spec.
Supply Requirements Evaluation Process Qualification Requirements
186 2024-11-18 Reference:
Technical Specification Excel Spreadsheet, row 114 on Temperature Control of Reagent on Slides
Request and Clarification:
Row 114 on Temperature Control of Reagent on Slides We would like to request increasing the minimum temperature control of reagent slides to 30
°C to 100 °C for the following reasons:
1. No IHC Stainer vendor or solution begin at a setting of 10°C; the industry practice is to start at 30°C
2. The current requirement of 10°C temperature will cause the wax melting process to slow down, resulting in longer dewaxing and staining times;
longer process means longer result delivery
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications.
Agreeable to the bidder's suggestion to the range of to 30°C to 100°C. The vendor is able to comply as long as the equipment is capable of reaching temperatures between 30 °C to 100 °C.
Supply Requirements Evaluation Process Qualification Requirements
187 2024-11-18 Dear Procurement Committee 4:
We are writing to seek additional clarification on the following questions, pursuant to Instructions to Bidder
(ITB 7.1) of the bidding documents:
Reference:
Technical Specification Excel Spreadsheet, row 206 on High pH Antigen Retrieval Solution
Request and Clarification:
Row 206 on High pH Antigen Retrieval Solution We recommend revising the High pH Antigen Retrieval Solution to
be replaced by “DAB Detection Solution”.
1. High pH Antigen retrieval solution is used specifically for ISH antibody only
2. There are no ISH antibody listed in the preferred list of 15 antibodies for this IHC usage
3. ISH antibody is not a routinary antibody listed in the BPJS, and as such
majority of Indonesia hospitals do not run this antibody
Many thanks for this feedback. As this specification is mandatory, the bidder can choose to comply or not. MoH will retain the current specification.
High pH Antigen Retrieval Solution is commonly used in Immunohistochemistry (IHC). It is a buffer solution designed to unmask antigenic sites on tissue samples that have been fixed in Formsalin and embedded in paraffin. The antigen retrieval process is necessary because Formsalin fixation cross- links proteins, which can obscure antigenic epitopes, making them inaccessible to antibodies.
Supply Requirements Evaluation Process Qualification Requirements
188 2024-11-18 Reference:
Technical Specification Excel Spreadsheet, row 127 on AntiEstrogen Receptor (ER)
Request and Clarification:
Row 127 on Anti-Estrogen Receptor (ER) We would like to request this specification be changed to mandatory (green criteria) instead of preferred (orange criteria). his is aligned with the MoH’s policies (Minister of Health Decree HK01.03/MENKES/6485/2021 and Regulation No. 3 of 2023) and mandate that specifies parameters, including the Anti-ER parameter, which must be tested prior to reatment.
Since this test is covered by the National Health Insurance, availability of
such application will encourage earlier diagnosis of non-communicable diseases which aligns with the national health objectives set by MOH.
Many thanks for this feedback. As this specification is rated criteria, the bidder can choose to comply or not. MoH will retain the current specification.
This provides an additional feature to remain as a neutral tech spec.
Supply Requirements Evaluation Process Qualification Requirements
189 2024-11-18 Reference in Bidding Document:
RFB Page 54: Section III – Evaluation and Qualification Criteria
The Bidders shall have past contract experience to supply and install IHK Set equipment of minimum cumulative 55 unit annually in any of year within the last seven (7) years prior to bid submission deadline.
Clarification/Question:
Considering that the immunohistochemistry stainer is the most critical and main equipment in this tender, would it be acceptable to provide documentation solely related to the stainer? Since the other equipments are counted as “additional accessories”.
If providing experience for all equipment is mandatory, would it be possible to provide relevant documents from the manufacturer for products that are not directly produced by the bidder?
Thank you for your question. We have revise the requirement as follows:
Based on the RFB, the bidder must be able to demonstrate experience in supplying and installing Microtomes annually in any one year and Automatic Immunohistochemistry Stainers annually in any one year within the last seven
(7) years. As the Microtomes and Automatic Immunohistochemistry Stainers is the most sophisticated component and represents the largest part of the cost, it will be considered as the key element of the bidder's experience. For a joint venture, this requirement may be met by all members combined. Maximum number of members in the JV shall be three (3). There is specific minimum percentage of participation outlined in the bidding document, but it is crucial that every member’s role is clearly defined and substantial enough to demonstrate their active involvement in the contract execution. In case bidder wants to submit PO/DO instead of contract page, the bidder still need to demontrate the experience not only delivery part, but also shows experience on the related services (installation). Please refer to 2nd Amendment IHK Set
Package issued on 18-12-2024.
Bidding Procedure Evaluation Process Specific Experience
190 2024-11-18 Reference:
Technical Specification Excel Spreadsheet, row 131 on Anti-Vimetin
Request and Clarification:
Row 131 on Anti-Vimetin
We would like to request that the preferred specification be changed to CD117 instead of Mesenchymal cells marker. CD 117 is mentioned in the MoH’s policy (Minister of Health Decree HK01.03/MENKES/6485/2021) to be tested prior to treatment. Therefore, It would be aligned with the utilization in the sites.
Many thanks for this feedback. As this specification is rated criteria, the bidder can choose to comply or not. MoH will retain the current specification.
This provides an additional feature to remain as a neutral tech spec.
Supply Requirements Evaluation Process Qualification Requirements
191 2024-11-19 Reference:
Reagent Refrigerator
Technical Specification Excel Sheet
Request and Clarification:
We would like to propose that the reagent refrigerator listed as one of the main equipment be moved to the accessories section of the technical specification sheet instead, For example, the slide printer is also a separate type of equipment, but it is listed as an accessory to the microtome.
Below are important factors we would like to highlight to substantiate our request:
Limited Competition/Risk for Re-tendering: We would like to highlight that refrigerators are not part of the product portfolio of any IHC or Pre- analytic manufacturing company therefore not only it is impossible for any bidder to prove the number of installations requested but also to provide any of the documents requested by this clause unless a refrigerator company joins a JV.
Given that only 1 company (Leica) can provide all the other 5 instruments and combined with the significant volume that is required under the tender, there will be no company that can bid even in a joint venture except for 1 company given the JV members are limited to only 3 companies. Other IHC firms will need to Forms JVs just to meet the experience requirement for the main IHC analyzer.
Proposed Solution: We would like to propose that the reagent refrigerator be moved as an accessory to the IHC analyzer instead. For example, the slide printer is also a separate type of equipment, but it is listed as an accessory to the microtome.
This will allow the MoH to procure the desired refrigerator equipment but still receive cost-effective bids. It is in the best interest of MoH to have the broadest possible competition and this is also supported by lsDB procurement guideline clause 1.40 that says the bid document shall promote the broadest possible competition.
Many thanks for this feedback. MoH will retain the current specification.
The IHK package as per MOH requirement includes the Reagent Refrigerator. Bidder is encourage to comply to all equipment required in this package.
Supply Requirements Evaluation Process Qualification Requirements
192 2024-11-19 Dear Procurement Committee 4:
We are writing to seek additional clarification on the following questions, pursuant to Instructions to Bidder (ITB 7.1) of the bidding documents:
Reference:
Manufacturing Experience and Technical Capacity Page 5S
Manufacturing experience and Technical Capacity: For the items under the Contract that the bidder is a manufacturer, the Bidder shall furnish documentary evidence to demonstrate that:
(i) it has manufactured IHK Set equipment for at least seven (7) years, prior to the bid submission deadline; and
(ii) its annual production capacity of IHK Set equipment for each of the last seven (7) years prior to the bid submission deadline, is at least 50% the quantities specified under each lot.
Request and Clarification:
On page 55, the bid document requires the Bidder to demonstrate that its annual production capacity of IHK Set Equipment for each of the last 7 years, is at least 50% of the quantities specified under each lot (which is equivalent to 250 units total for 4 lots).
Clarification/Request:
We would like to request your confirmation that this requirement can be met if the bidder can demonstrate the required manufacturing capacity of 50% for ere-analytic equipment specific for histooatholoev COMBINED (i.e. microtome, cold plate, hot plate, water baths, tissue processors, grossing stations, embedding systems, H&E stainers, ventilated cabinets). This would mean that manufacturing experience of 1 microtome and 1 tissue processor would count as 2 units in a year).
Below are important factors we would like to highlight to substantiate our request/clarification:
Main Analyzer vs Pre-Analytic Equipment: The required manufacturing capacity is appropriate for the main IHC analyzer (automatic IHC stainer) since there is a larger analyzer market worldwide. However, the global market for the required pre-analytic equipment such as cold plate, hot plate, and microtomes is very fragmented with only a few high-quality manufacturers sharing a niche market where the quantities are very limited.
Limited Competition/Risk for Re-tendering: We are confident to state that if the bid requires 250 units per year individually for each pre-analytical equipment, 99% of the pre-analytic manufacturers will not be able to bid even in a JV. Only 1 company in the world (Leica Biosystem) will be capable of meeting such manufacturing requirements. The risk for the committee is to have a tender with limited competition leading to higher costs for the purchaser and only 1 bidder on one or more or even all the lots of this tender.
Proposed Solution: The proposed solution to allow bidders to meet the required manufacturing capacity of 50% of the lot quantity annually for the last 7 years using manufacturing experience for pre-analytic equipment specific for histooathologv COMBINED will allow the MoH to receive cost competitive bids while still maintaining a high quality
standard for the last 7 years.
Please refer to the respective response on the question #20. Bidding Procedure Evaluation Process Evaluation Criteria
193 2024-11-21 As official representative of XXXX, I’m hereby submitting to your attention our requests for clarifications for the Procurement of IHK set, KS.01.02/A. VI/6167/2024
Request for clarification:
Question: Some of the technical specifications requested for Microtomes, Water Bath, Hot Plate and Cold Plate are not listed usually into their Data Sheet, User Manuals or Service Manuals. Will it be accepted by the committee a statement letter issued by the manufacturer as an integration to the existing technical documentation that certifies the actual compliance of the offered equipment to such reuirements?
Thank you for your attention and best regards
Thank you for your question. Bidder to refer to Bidding documents, ISDB and MOH on approved documents referring to RFB page 54. Bidding Procedure Evaluation Process Qualification Requirements
194 2024-11-22 Dear Procurement Committee 4:
We are writing to seek an extension of the deadline for the submission of bids for the procurement of IHK Set
(KS.01.02/A.VI.6167/2024).
Reference:
Bid Deadline ITB 22 Page 26
Request:
We respectfully request the MOH to extend the bid deadline for the Procurement of IHK Set by an additional 4 weeks (i.e. from December 09, 2024 to January 09,
25).
Below are key details to support our request:
1. Lack of Clarifications: As of November 22, 2024, there has been no response from the Purchaser to answer any clarifications sent by prospective bidders since the request for bids (RFB) for the IHK Set was published on Oct 11, 2024
2. Sufficient Time for Bidders to Prepare the Bid: As per paragraph 1.39 of the IsDB Guidelines for the Procurement of Goods under IsDB Project
Finance (revised February 2023) and referenced also by ITB 22.2, we any additional nFormsation, clarification, correction of errors or modifications of the Bidding Documents shall be sent to each Bidder in sufficient time before the deadline for receipt of Bids to enable bidders to take appropriate action. If necessary, the deadline shall be extended ".
3. 10 Working Days remaining before the original Bid deadline: With only 10 business days remaining prior to bid deadline, the bidders do not have sufficient time to act on clarifications by the MoH. The short bid deadline postponement requested will allow the MoH time to respond to these clarifications, as well provide the bidders time to review the MoH's responses and to take necesserry action. We recognize that the MoH's careful response to clarification questions requires sufficient time
Many thanks for your interest in this Procurement of IHK Set. MoH has considered this request and extended the bid submission period to December, 30th 2024 refer to Addendum No.2. Please visit the website regularly to get the update. Any amendment to the Bidding Document (if needed), responses to clarification to the Bidding Document, and schedule are also published on IHSS website. General Inquiry Related to Proc Plan and Packaging Arr. Question related to Procurement Planning and Packaging Arrangements
195 2024-11-22 7. Whats meaning of Optical accessories in table row 164? Optical accessories describes Large Field Magnifier, Zoom-Stereomicroscope Bidding Procedure Evaluation Process Evaluation Criteria
196 2024-11-22 6. For the equipment specifications, accessories such as the Slide Printer (Table row 159), Embedding Console (row 160), and Optical Accessories (Table row 164) are different devices, separate units, and have distinct specifications that are not part of the microtome. Therefore, it is better not to classify them as accessories, but rather as equipment requirements within the IHK Set. Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications.
Agreeable to the bidder's suggestion to amend accessories as preferred.
Supply Requirements Evaluation Process Qualification Requirements
197 2024-11-22 Good morning, Procurement Committee of IHK Set - SIHREN,
We are PT XXX, and we would like to ask a few questions regarding points related to the World Bank requirements:
1. Regarding the IHK Set, which consists of several equipment units, we have collaborations with various manufacturers. Is it permissible to Forms a Joint Venture (JV) only with the manufacturer of the main unit (IHC Stainer), while the other manufacturers provide supporting letters? Or is it mandatory for all manufacturers involved in the IHK Set to be members of the JV? Considering that the JV membership is limited to a maximum of three companies.
We sincerely appreciate your attention and response. Thank you in advance.
Thank you for your question. We have revise the requirement as follows:
Based on the RFB, the bidder must be able to demonstrate experience in supplying and installing Microtomes annually in any one year and Automatic Immunohistochemistry Stainers annually in any one year within the last seven
(7) years. As the Microtomes and Automatic Immunohistochemistry Stainers is the most sophisticated component and represents the largest part of the cost, it will be considered as the key element of the bidder's experience. For a joint venture, this requirement may be met by all members combined. Maximum number of members in the JV shall be three (3). There is specific minimum percentage of participation outlined in the bidding document, but it is crucial that every member’s role is clearly defined and substantial enough to demonstrate their active involvement in the contract execution. In case bidder wants to submit PO/DO instead of contract page, the bidder still need to demontrate the experience not only delivery part, but also shows experience on the related services (installation). Please refer to 2nd Amendment IHK Set
Package issued on 18-12-2024.
Bidding Procedure Procurement Regulations Eligible Bidders (including joint venture)
198 2024-11-22 5. For documents that need to be translated, is it mandatory for the translation to be done by a sworn/professional translator, or are we allowed to translate them ourselves? All language of the bid is English. The bidder must provide a bid document with good grammar to avoid any misunderstandings by the MoH. The Bid, as well as all correspondence and documents relating to the Bid exchanged by the
Bidder and the Purchaser, shall be written in the language specified in the BDS. Supporting documents and printed literature that are part of the Bid may be in another language provided they are accompanied by an accurate translation of the relevant passages into the language specified in the BDS, in which case, for purposes of interpretation of the Bid, such translation shall
govern. Please refer to Section I - ITB, C, 10.1 Language of Bid.
Bidding Procedure Procurement Regulations Forms
199 2024-11-22 3. For the mandatory accessory of the microtome STS (Section Transfer System) mentioned in the Technical Requirements, is it possible for this requirement to be revised or made non-mandatory? Considering that only a few companies are able to meet this specification. Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications.
Agreeable to the bidder's suggestion to remove the specification.
Supply Requirements Evaluation Process Qualification Requirements
200 2024-11-22 4. For the minimum specific experience and manufacturer’s production capacity, we request that it not be required as a SET. This requirement proses a significant challenge and burden for us as bidders, since each piece of equipment is different, with separate manufacturers, uses, and sales. If experience is required to be a SET, we suggest allowing a joint venture to include up to 6 members. Alternatively, it could be sufficient to require experience from only one primary piece of equipment, such as the Automatic Immunohistochemistry Stainer. Thank you for your question. We have revise the requirement as follows:
Based on the RFB, the bidder must be able to demonstrate experience in supplying and installing Microtomes annually in any one year and Automatic Immunohistochemistry Stainers annually in any one year within the last seven
(7) years. As the Microtomes and Automatic Immunohistochemistry Stainers is the most sophisticated component and represents the largest part of the cost, it will be considered as the key element of the bidder's experience. For a joint venture, this requirement may be met by all members combined. Maximum number of members in the JV shall be three (3). There is specific minimum percentage of participation outlined in the bidding document, but it is crucial that every member’s role is clearly defined and substantial enough to demonstrate their active involvement in the contract execution. In case bidder wants to submit PO/DO instead of contract page, the bidder still need to demontrate the experience not only delivery part, but also shows experience on the related services (installation). Please refer to 2nd Amendment IHK Set
Package issued on 18-12-2024.
Bidding Procedure Evaluation Process Specific Experience
201 2024-11-22 2. There are several accessories and consumables in the IHK Set that manufacturers have inquired about as they lack understanding and are unable to obtain clear inFormsation. Regarding this issue, is there any support available for clarification on these accessories and consumables? Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications.
Amended to Preferred; Bidder to supply a quantity of 100 tests
Supply Requirements Evaluation Process Qualification Requirements
202 2024-11-22 9. We kindly request that, given the numerous questions and suggestions from various vendors, the document submission deadline be postponed until January 2025.
These are our questions, and we hope they will be answered in detail. We also ask that our suggestions be considered to allow wider vendor participation beyond specific brands.
Thank you for your attention.
Many thanks for your interest in this Procurement of IHK Set. MoH has considered this request and extended the bid submission period to December, 30th 2024 refer to Addendum No.2. Please visit the website regularly to get the update. Any amendment to the Bidding Document (if needed), responses to clarification to the Bidding Document, and schedule are also published on IHSS website. General Inquiry Related to Proc Plan and Packaging Arr. Question related to Procurement Planning and Packaging Arrangements
203 2024-11-22 2.We plan to Forms a joint venture with the manufacturer of these equipment. Would the minimum specific experience in installation still be required? If possible, we suggest that only the manufacturer’s production capacity be considered, without the need for installation experience. Thank you for your question. We have revise the requirement as follows:
Based on the RFB, the bidder must be able to demonstrate experience in supplying and installing Microtomes annually in any one year and Automatic Immunohistochemistry Stainers annually in any one year within the last seven
(7) years. As the Microtomes and Automatic Immunohistochemistry Stainers is the most sophisticated component and represents the largest part of the cost, it will be considered as the key element of the bidder's experience. For a joint venture, this requirement may be met by all members combined. Maximum number of members in the JV shall be three (3). There is specific minimum percentage of participation outlined in the bidding document, but it is crucial that every member’s role is clearly defined and substantial enough to demonstrate their active involvement in the contract execution. In case bidder wants to submit PO/DO instead of contract page, the bidder still need to demontrate the experience not only delivery part, but also shows experience on the related services (installation). Please refer to 2nd Amendment IHK Set
Package issued on 18-12-2024.
Bidding Procedure Procurement Regulations Eligible Bidders (including joint venture)
204 2024-11-22 5. Currently, only one brand is capable of producing 5 out of the 6 instruments in the set, which means that the specifications and minimum joint venture requirements favor this brand alone. Could this be taken into consideration? Thank you for your question. We have revise the requirement as follows:
Based on the RFB, the bidder must be able to demonstrate experience in supplying and installing Microtomes annually in any one year and Automatic Immunohistochemistry Stainers annually in any one year within the last seven
(7) years. As the Microtomes and Automatic Immunohistochemistry Stainers is the most sophisticated component and represents the largest part of the cost, it will be considered as the key element of the bidder's experience. For a joint venture, this requirement may be met by all members combined. Maximum number of members in the JV shall be three (3). There is specific minimum percentage of participation outlined in the bidding document, but it is crucial that every member’s role is clearly defined and substantial enough to demonstrate their active involvement in the contract execution. In case bidder wants to submit PO/DO instead of contract page, the bidder still need to demontrate the experience not only delivery part, but also shows experience on the related services (installation). Please refer to 2nd Amendment IHK Set
Package issued on 18-12-2024.
Bidding Procedure Procurement Regulations Eligible Bidders (including joint venture)
205 2024-11-22 3. For the manufacturer’s experience requirement, we kindly request it to be set at 5 years. This is due to the fact that the equipment specified is advanced, and many manufacturers have only started production within the past 5 years. Thank you for your inquiry. The requirement for seven years of manufacturing experience on IHK Set equipment is based on market approach considering IHK Set is such of mature medical devices industries. Bidding Procedure Evaluation Process Specific Experience
206 2024-11-22 8. Regarding equipment importation, if the holder of the distribution license is not a member of the JV, could you please provide clarification on this matter? Many thanks for the question. MoH recommend bidder to have JV with the license holder. As specified in the relevant Bidding Document, the possession of a Nomor Izin Edar (NIE, Distribution Permit Number) shall not be a pre- condition for the bidders to participate in the bidding process and shall not be the basis for rejection. In the event that a successful Bidder does not possess a NIE, they will be offered an accelerated track for registration before contract signing. Supply Requirements Evaluation Process Technical Evaluation
207 2024-11-22 6. For documents exceeding 100 pages, is it necessary to translate all pages, or would it suffice to translate only the summary? Please refer to the respective response on the question #206 Bidding Procedure Procurement Regulations Forms
208 2024-11-22 4. If the ISO 27000/27001 (Cyber Security) certificate has expired and is currently in the renewal process, is it acceptable for us to submit a declaration letter first, with a commitment to provide the renewed ISO certificate once it is issued, to fulfill the Cyber Security ISO requirement? If the ISO 27000/27001 (Cyber Security) certificate on progress to renewal, bidder can provide Declaration Letter. Bidder must clearly demonstrates the bidder's experience in managing cyber security, practice and track record, including relevant Cyber security accreditation such as ISO 27000 (ISO 27001) or equivalent, and commits to ensure these cybersecurity requirements for all devices part of the bid. The bidder is also requested to provide relevant equipment cybersecurity mitigation measures via their MDS2 Forms in the bid. Bidding Procedure Evaluation Process Evaluation Criteria
209 2024-11-22 Good Afternoon Sir/Madam Procurement Committee,
Allow me to introduce myself, I am XXX from PT XXX, and we are interested in participating in the procurement of IHK Set for the SIHREN IsDB project. We have a few questions and suggestions, which are as follows:
If we become a bidder and wish to participate in all lots (Lot 1 - Lot 4), will the minimum specific experience and manufacturer production capacity requirements in the RFB document be cumulative (i.e., added up across Lots 1-4 for a total of 150 units), or will the experience requirements apply separately to each lot? If possible, we suggest that the requirements not be cumulative, so that more vendors may have the opportunity to participate.
Thank you for your question. The same specific experience documents can be used repeatedly for different lots provided that meet the minimum requirement for the each respective lots. Each lot must be supported by documentation that demonstrates the necessary experience specifically for that lot.
In case one bidder is to be recommended to be awarded the contract for more than one lot, such bidder shall meet the cumulative minimum requirement of point (a) financial capability and (b) specific experience respective lots. The contract will be determined based on the most advantageous bids. Refer to the RFB, Technical Part, Section III Evaluation and Qualification Criteria
Bidding Procedure Procurement Regulations Procurement Methodology
210 2024-11-25 QUESTION 2
BID SUBMISSION POSTPONEMENT
Considering that no question raised to the committee from potential bidder has been answered yet and the time remaining before the bid submission deadline is very short, we are concerned the bidders will not manage to adapt their offers and documentation on the time with the deadline requested in the tender.
We would like to ask the committee to pospone the bid submission date one month forward in order to allow all the bidders to have enough time to
comply whit the eventual new requirements (jan 9th 2025)
Many thanks for your interest in this Procurement of IHK Set. MoH has considered this request and extended the bid submission period to December, 30th 2024 refer to Addendum No.2. Please visit the website regularly to get the update. Any amendment to the Bidding Document (if needed), responses to clarification to the Bidding Document, and schedule are also published on IHSS website. General Inquiry Related to Proc Plan and Packaging Arr. Question related to Procurement Planning and Packaging Arrangements
211 2024-11-25 Dear Sir/Madam,
Considering the Bidding Document soliciting tender applications for:
∙ Contract Title : Procurement of IHK Set
∙ RFB Reference No.: KS.01.02/A.VI/6167/2024
We are writing this letter to request a clarification on the following
Clause Reference in Tender Document:
Technical Specification – IHK Set Row 23:
Type : Semiautomatic/Automatic, a semiautomated rotary microtome combining mechanized feed with manual cutting
Clarification / Propose for Revision:
To ensure the mandatory requirements are filled with only general requirements, we would like to raise that
1. Section Transfer System (STS) is a registered trademark of Epredia, making this an exclusive parameter that cannot be met by other brands.
2.This parameter conflicts with line 23, as it is exclusive to fully automatic microtomes while the line suggest it can choose semiautomatic/automatic.
3. This feature is an optional add-on with a high cost and limited practicality, offering no real benefit for IHC applications.
Thus, it is suggested to remove this mandatory requirement
Many thanks for this feedback.The bidder can choose to comply or not. MoH will retain the current specification.
The specification refers to a semiautomatic OR automatic rotary microtome to which bidders may select either key feature.
Contract Contract Management Contract
212 2024-11-25 We from PT XXX would like to inquire regarding the technical requirements (from the Excel document). There are several points that we (the manufacturer) do not fully understand about the requirements mentioned, and we kindly request your assistance in providing clarification on the specific requirements intended. The details are as follows:
C. Tissue Floating Bath
1. Raised shelf
2. Transparent polycarbonate lid for SAPXX
3. Stainless steel sloping lid for SAPXX
4. Flat lid with 2 ring sets for SAPXX
5. Base Tray for SAPXX
Thank you for your question. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications.
No. 1: A "Raised Shelf" is an accessory designed for laboratory water baths to elevate vessels, allowing for reduced liquid depth and accommodating shallow containers. Typically made of perforated stainless steel, these shelves facilitate free circulation of water and can be easily removed for cleaning: available in various sizes to fit different bath models. Example (non brand specific) as below:
Bidding Procedure Evaluation Process Qualification Requirements
213 2024-11-25 We are writing to seek additional clarification on the following questions, pursuant to Instructions to Bidder
(ITB 7.1) of the bidding documents:
Reference:
Technical Specification Excel Spreadsheet
Request and Clarification:
We would like to propose Hematoxylin and Eosin (H&E) autostainer to be the mandatory specification for IHK Set Procurement.
Hematoxylin and Eosin (H&E) is the mandatory and important step to scoring tumor cell based on the morphology type. This H&E staining is the primary staining after pre-analytic process. Current IHK set only require the pre-analytic (microtome, slide drying hotplate, cold plate and tissue floating bath) and Immunohistochemistry Stainer as the advance staining.
Below is our suggestion for the minimum Hematoxylin and Eosin autostainer specification which also do not lock to one vendor.
- Type: Automatic H&E stainer
- Open reagent compatibility: - Allowed to use stain Solutions and reagents from any vendor
- Reagent management: equipped with reagent management system software able to inForms the user on the reagent replacement needs based on days of usage from reagent installation or number of baskets stained
- Reagents reservoir: at least 40 reservoirs for reagents
- Dewaxing mode: at least 1 oven station for dewaxing purposes
- Operating system: visual and acoustic alarms with alarm inFormsation displayed on the software screen
- Water supply option: tap water connection
- Slide running option: possibility to manage more than one basket at the same time
- Running option: possibility to save and use more than 1 staining protocol in the software
- Contamination control: possibility to select different dripping option to reduce cross contamination.
- Throughput: at least 100 slides per hour
We suggest H&E stainer as one of mandatory instrument part of IHK set rather than as only preferred specification. This instrument will connect the pre-analytic and IHC stainer and also make sure the IHK set package can be useful for 500 target hospitals.
Pathologists need to process H&E staining on the tumor/cancer sample to
understand and decide which IHC test to perForms on the sample.
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications.
Agreeable to the bidder's suggestion for all test/assay menu to be preferred
Supply Requirements Evaluation Process Qualification Requirements
214 2024-11-25 E. Microtome
Regarding the requirements for "Setting values," we kindly request that this be considered non-mandatory, as not all microtomes have the exact same range of setting values. Our specifications meet all the requirements, but with a different value range.
Many thanks for this feedback. The bidder can choose to comply or not. MoH will retain the current specification.
The "Settings values" (row 39- mandatory; 40, 44 - preferred values) ensures the models proposed adhere to ranges available and preferred for additional key features. Bidder's suggestion may be restrictive to one specific model.
Bidding Procedure Evaluation Process Qualification Requirements
215 2024-11-25 Clause Reference in Tender Document:
Technical Specification – IHK Set Row 115 Slide Capacity:
Slide Capacity : ≥ 20 slides
Clarification / Propose for Revision:
At present, world mainstream stainers generally support 30 or more slides, with only devices released before 2000 supporting 20 slides. Since mandatory standard has been raised up to 30, it is suggested to remove the optional requirement.
Many thanks for this feedback.The bidder can choose to comply or not. MoH will retain the current specification.
The setting is set at a minimum of 20 to remain as a neutral tech specs.
Supply Requirements Evaluation Process Qualification Requirements
216 2024-11-25 Clause Reference in Tender Document:
Technical Specification – IHK Set Row 161:
Section Transfer System STS Bidder required to supply
Clarification / Propose for Revision:
To ensure the mandatory requirements are filled with only general requirements, we would like to raise that
1. Section Transfer System (STS) is a registered trademark of Epredia, making this an exclusive parameter that cannot be met by other brands.
2.This parameter conflicts with line 23, as it is exclusive to fully automatic microtomes while the line suggest it can choose semiautomatic/automatic.
3. This feature is an optional add-on with a high cost and limited practicality, offering no real benefit for IHC applications.
Thus, it is suggested to remove this mandatory requirement
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications.
Agreeable to the bidder's suggestion to remove the specification.
Supply Requirements Evaluation Process Qualification Requirements
217 2024-11-25 We from PT XXX would like to inquire regarding the technical requirements (from the Excel document). There are several points that we (the manufacturer) do not fully understand about the requirements mentioned, and we kindly request your assistance in providing clarification on the specific requirements intended. The details are as follows:
B. Hot Plate
1. Boss Head Clamp
2. Holding rod
3. Vertical Support rod
Bidding Procedure Evaluation Process Qualification Requirements
218 2024-11-25 Once the Bidder has won as a JV, which entity will receive the issued PO from MOH? And how to invoice and tax exemption process be? Will the JV needed to be established as a new entity for the process to be conducted? MoH will make payments based on the invoices issued by the bidder. Members of the JV are welcome to determine which company will issue the invoice to the MoH. Tax exemptions will be granted to the bidder who submits the invoice to the MoH.
A mechanism has been prepared to handle import taxes, VAT, and other customs duties under the current project. Once there is a notification of the successful bidder, MoH will submit a tax exemption request to the Ministry of Finance for the specified bidder, and will assist the successful bidder throughout the process. It is important to note, however, that facilities relating to import taxes, VAT, and other customs duties under the current project will only be granted to the main contractor. Subcontractors, by contrast, are not eligible to receive these exceptions. In the case of a joint venture, all members will be eligible to benefit from the exemptions. Please refer to ITB 14.8 of the bidding documents on component of bid prices.
Contract Contract Management Taxes
219 2024-11-25 QUESTION 5
On page 55, the bid document requires the bidder to demonstrate that its annual production capacity of IHK Set Equipment for each of the last 7 years, is at least 50% of the quantities spcified under each lot (which is equivalent to 250 units total for 4 lots).
We would like to remark again our concern on the effects of a fair competition arasing from this requirement.
Except for two companies on the market, XXX and XXX, who are manufacturing the requested products since more than a decade, the rest of the highest quality and reputable manufacturers may not have started the production of one ore more of the requested products more thab 7 years ago and be able to provide the numbers requested by this clause. keeping this requirement as it is, will directly impact the fair competition on this tender and allow only one company to bid for all the lots, providing a critical competitive advantage to this company and undermining the chances of other bidders to offer their products at lower prices and for all the lots, despite their capability to provide and ensure even more production capacity than the one requested from this tender.
The objective of tenders is to ensure the broadest possible competition in order to obtain the best possible purchasing condition for the purchaser. we believe this requirement doesn't allow the purchaser to achieve and satisfy this objective.
We would like to propose to consider to replace this requirement by cosidering the combined production of 250 systems for IHK and or Pre Analytic histopathology in the last 7 years.
Thank you for the opportunity to submit our clarifications and we look forward to receiving your feedback.
Thank you for your question. We have revise the requirement as follows:
Based on the RFB, the bidder must be able to demonstrate experience in supplying and installing Microtomes annually in any one year and Automatic Immunohistochemistry Stainers annually in any one year within the last seven
(7) years. As the Microtomes and Automatic Immunohistochemistry Stainers is the most sophisticated component and represents the largest part of the cost, it will be considered as the key element of the bidder's experience. For a joint venture, this requirement may be met by all members combined. Maximum number of members in the JV shall be three (3). There is specific minimum percentage of participation outlined in the bidding document, but it is crucial that every member’s role is clearly defined and substantial enough to demonstrate their active involvement in the contract execution. In case bidder wants to submit PO/DO instead of contract page, the bidder still need to demontrate the experience not only delivery part, but also shows experience on the related services (installation). Please refer to 2nd Amendment IHK Set Package issued on 18-12-2024.
Bidding Procedure Evaluation Process Specific Experience
220 2024-11-25 Clause Reference in Tender Document:
Technical Specification – IHK Set Row 116 Slide Capacity:
Slide Capacity : ≥ 40 slides
Clarification / Propose for Revision:
At present, world mainstream stainers generally support 30 or more slides, with only devices released before 2000 supporting 20 slides. Since mandatory standard has been raised up to 30, it is suggested to remove the optional requirement.
Many thanks for this feedback.The bidder can choose to comply or not. MoH will retain the current specification.
The setting is set at a minimum of 40 to remain as a neutral tech specs. The preferred provides an additional feature for more slide capacity.
Supply Requirements Evaluation Process Qualification Requirements
221 2024-11-25 QUESTION 3
HOT PLATE TECHNICAL SPECIFICATION - LINE 68 - TTOP PALTE MATERIAL - CERAMIC
we ask the committe either to remove the mandatory request to have ceramic hot plate surface material as this requirement is too specific and not common on the market of histopathology. We would like to suggest to either include more materials commonly used for this kind of equipment such as alluminium or to remove this request from the list.
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications.
Ceramic, is a material (without proprietary trademark), has an advantage over aluminium hot plate material i.e., uniForms heat distribution, higher temperature resistance, superior chemical resistance, greater durability, easier cleaning, excellent electrical insulation, inert surface, and enhanced visibility.
The specification is amended to be preferred.
Supply Requirements Evaluation Process Qualification Requirements
222 2024-11-25 Dear Procurement Committee 4:
We are writing to seek additional clarification on the following questions, pursuant to instructions to Bidder (ITB 7.1) of the bidding documents:
QUESTION 1
Background/justification:
after a survey on the status of some sites listed in the tender for which the IHK Set are requested, we realize many of them may lack a complete pre analytica structure to run effectively the IHK lab. in particular we are concerned about the lack of H&E system to run the primary staining, mandatory for the patologists to understand what kind of advanced staining (IHK) to request for each patient. not having this systems in place will lead to a situation where it will be impossible to use the IHK set requested in this tender.
we would like to ask the committee to consider to add as mandatory requested system also the H&E stainer and we take the opportunity to suggest some minimum technical spesifications that would fit any lab and any workload possible.
Hematoxylin and Eosin autostainer
- Automatic H&E Stainer
- Reagent management system available in the software
- At leat 40 reservoirs for reagents
- At least 2 oven station for dewaxing purposes
- Visual and acoustic alarm
- Tap Water connection
- Slide running option: simoultaneous
- Running option: possibility to save and run different staining protocols in the software
- Productivity of at least 100 slides per hour
- Remote technical service avilable through internet connection
Many thanks for this feedback. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications.
IHK stainer are clarified in multiple rows related. The specifications permits mandatory features and amended preferred features to ensure neutral specifications.
Bidding Procedure Evaluation Process Qualification Requirements
223 2024-11-25 D. Refrigerator
Does the refrigerator need to be a medical-grade refrigerator, or can any type of refrigerator be used?
The requested temperature range for the refrigerator is 2-12°C. Typically, refrigerators only operate within the 2-8°C range. We kindly ask for your consideration in adjusting this requirement, as reagent storage refrigerators generally maintain a temperature range of 2-8°C.
Thank you for your question. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications.
An IHC set refrigerator must be a medical-grade or laboratory-grade refrigerator to maintain the integrity of reagents, slides, and other IHC materials. Amended temperature range to 2°C to 8°C.
Bidding Procedure Evaluation Process Qualification Requirements
224 2024-11-25 QUESTION 4
Completion certificates / Installation report page 55
"The bidder is required to provide both installation and PO/DO to prove experience qualification."
We would like to remark again our concern on this request and ask for a revision of the kind of requested documents and equipment subjected to it:
- GDPR, data breach and all the privacy regulations on the sharing of sensible data DO NOT allow manufacturers to collect these inFormsation independently and easly. for each of the documents requested, bidders will need a signed approval Forms the purchaser in order to be allowed to deliver them, making this process impossible to most of the manufacturers
- Most of Pre Analytic manufacturers work on a B2B model around the world. this means that most of those documents are in the name of their official distributors, not the manufacturer one. since the JV max participants are 3, it is impossible to fit into the JV all the distributors companies for the sole purpose of delivering these equipment documents
- Hot Plate and Water Bath are simple equipment, often sold with credit card payments and most of the time not requiring any installation report. This makes impossible for many manufacturer to have the requested documents for these products
- The refrigerator is a product not produced by any IVD product' manufacturer, both in the case we consider IHK or Pre Analytic manufacturer. There is no chance for us or any other company to provide
the experience and completion certificates on this product
Thank you for your question.
If any such contract includes a confidentiality or non-disclosure clause, and the bidder is unable to provide a copy (which should be confirmed by a Formsal letter), the bidder must submit alternative documents acceptable to the Ministry of Health (MoH), such as a copy of the purchase order or delivery order.
We have revise the requirement as follows:
Based on the RFB, the bidder must be able to demonstrate experience in supplying and installing Microtomes annually in any one year and Automatic Immunohistochemistry Stainers annually in any one year within the last seven
(7) years. As the Microtomes and Automatic Immunohistochemistry Stainers is the most sophisticated component and represents the largest part of the cost, it will be considered as the key element of the bidder's experience. For a joint venture, this requirement may be met by all members combined. Maximum number of members in the JV shall be three (3). There is specific minimum percentage of participation outlined in the bidding document, but it is crucial that every member’s role is clearly defined and substantial enough to demonstrate their active involvement in the contract execution. In case bidder wants to submit PO/DO instead of contract page, the bidder still need to demontrate the experience not only delivery part, but also shows experience on the related services (installation). Please refer to 2nd Amendment IHK Set Package issued on 18-12-2024."
Bidding Procedure Evaluation Process Specific Experience
225 2024-11-25 We from PT XXX would like to inquire regarding the technical requirements (from the Excel document). There are several points that we (the manufacturer) do not fully understand about the requirements mentioned, and we kindly request your assistance in providing clarification on the specific requirements intended. The details are as follows:
A. IHK Stainer
1. RDA (Rapid Diagnostic Assay)
2. RDA-Tags
3. RDA-Tag Label Kit
4. Workflow Organizers
5. Cleaning head adapter
Thank you for your question. MoH has considered this input and will update the specification and included in a forthcoming amendment to the specifications.
No. 1 - 3: Understanding it may be more vendor specific, RDA, RDA-Tags, RDA-Tag Label Kit is removed.
No. 4: To maintain neutral specification, the specification is amended to "White'.
Workflow Organizers are integral components designed to enhance laboratory efficiency and streamline processes. For example Slide Staining Trays and Racks, Reagent Dispensing Systems, Slide Labelling and Tracking Accessories, Automated Slide Stainers, Waste Management Systems.
BenchMark ULTRA (Roche) & Dako Omnis (Agilent) can comply to given examples in column I; BOND-III (Leica) & Tissue-Tek Genie (Sakura Finetek) comply to most but not all.
No. 5: It refers to a component used during maintenance cycles to facilitate the cleaning of system components such as waste tubs, fluid reservoirs, or reagent pathways. This adapter could help in directing cleaning fluids or connecting cleaning apparatuses for effective cleaning.
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