Rfb024/25/26 - Placement of Mycobacterial Culture and Drug Susceptibility Tes...

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Mycobacterial culture is a laboratory technique used to grow mycobacteria, including mycobacterium tuberculosis, in a culture medium to identify and diagnose mycobacterial diseases like tuberculosis, as well as perform drug susceptibility testing. Currently, the NHLS has 16 laboratories performing tb culture and seven performing phenotypic drug susceptibility tests (in a subset of these laboratories). There are 160 culture instruments within these laboratories, which are aged and most have reached end of life. In addition, 10 laboratories have mycobacteria blood culture instruments (28 across all 10 laboratories), all of which have aged and have reached end of life (ie cannot be maintained or repaired), and some not functional at all, resulting in delays in results and negatively impacting patient care. Therefore, there is a need for mycobacteria culture and drug susceptibility testing instruments. Confidential of 68 RFB024/25/26: Placement of Mycobacterial Culture and Drug Susceptibility testing instruments including reagents, consumables, service and maintenance for a period of five (5) years at National Health Laboratory Service Nationally. Specifications for National Tender for Mycobacteria Culture and DST A. Mycobacterium Liquid medium culture (pulmonary and extrapulmonary) • Automated system for liquid culture for mycobacteria • Non-radiometric technology • Free standing with built-in incubator at recommended temperature for incubation. • Automated system – i.e. indicator allow users to view when a culture is positive. • Must indicate end of incubation period, indicating no growth • Be able to alert user of errors (specimens and instrument) e.g. sound or visual alert, or pop-up notification • The instrument must have barcode scanning capabilities • Must include a calibrating mechanism • Must be capable of doing DST with WHO recommended critical concentrations for the for 1st and 2nd-line TB drugs relevant in the TB program • Capable of performing DST on new in-house prepared drugs, used in the programme, where no commercial kit is available • Middleware for multiple platform integration for culture and DST e.g. culture contamination reports, culture positive reports, DST volume reports, resistance reports etc. • Sputum and extrapulmonary sample types can be processed on the instrument. • Middleware that links the different instruments • Software updates should be installed as they arise and at the bidder’s cost • Must be capable of interface with the NHLS Lab Information System. B. Mycobacterium Blood culture system • Media range should include standard media for mycobacteria culture with antibiotic neutralizing capabilities and be suitable for paediatric samples. • Media components should not interfere with microscopy staining techniques (Gram and or Ziehl Neelsen staining) • Free standing / bench-top instrument types to cater for low and high throughput laboratories. • Must be able to flag positive i.e. indicate to user when a culture is positive • Must indicate end of incubation period, indicating no growth • Must be capable of interface with the NHLS Lab Information System C. General Instrument requirements Power requirements Direct to South African wall socket Operating Voltage: 240V Electronic voltage SA compliant yes UPS yes Safety compliant Regulatory Marking Weight should be able to replace current instruments in-use without any additional infrastructural changes Ergonomic Design yes Operator manual yes Maintenance 5 years contract included Maintenance & Support Contract for duration of the tender Delivery period within 3 months of award Support on-site within 48 hours Aftersales service yes Warranty period included in maintenance contract D. Contract requirements Contract period 5 Years Training and Support Yes Confidential of 68 RFB024/25/26: Placement of Mycobacterial Culture and Drug Susceptibility testing instruments including reagents, consumables, service and maintenance for a period of five (5) years at National Health Laboratory Service Nationally. Service and Maintenance Yes Middleware As per site requirements Consumables and Reagents Estimated 1,000,000 per annum for both culture and pDST Instruments Will be quantified by site volumes 4. MANDATORY REQUIREMENTS If a bidder does not comply fully with each of the mandatory requirements, it Shall be regarded as mandatory non-performance/non-compliance and the bid Shall be disqualified. No “unanswered” questions will be allowed. If a response to a question has been indicated as comply but not elaborated upon or substantiated it shall be regarded as mandatory non- performance/non-compliance, and the bid shall be disqualified. Bidders shall provide full and accurate answers to the mandatory questions posed in this document, and, where required, explicitly state either “Comply/Accept (with a “Yes”)” or “Do not comply/do not accept (with a “No”)” regarding compliance to the requirements. Bidders must substantiate their responses to all mandatory questions. PLEASE NOTE: If the response does not substantiate any of the points or requirements in the body of the tender, it will be deemed to not comply, even if the ‘Comply’ field has been marked. Please note: All documentation to substantiate the mandatory requirements has to be supplied 4. TECHNICAL SUITABILITY: MANDATORY REQUIREMENTS (Note: The bidder who fails to comply with the Mandatory Requirement WILL be disqualified). MYCOBACTERIUM LIQUID MEDIUM CULTURE (PULMONARY AND EXTRAPULMONARY) Technical Suitability: Mandatory Requirement Automated liquid culture system for mycobacteria with automated Comply Do Not Comply detection of growth Substantiation: The bidder must submit and attach to the bid response, a proof by means of brochure/ Specification. Failure to provide information will lead to disqualification. Technical Suitability: Mandatory Requirement Non-radiometric technology Comply Do Not Comply Substantiation: The bidder must submit and attach to the bid response, a proof by means of brochure/Specification. Failure to provide information will lead to disqualification. Technical Suitability: Mandatory Requirement Free standing with built-in incubator at recommended temperature for Comply Do Not Comply incubation. Substantiation: The bidder must submit and attach to the bid response, a proof by means of brochure/ Specification. Failure to provide information will lead to disqualification. Confidential of 68 RFB024/25/26: Placement of Mycobacterial Culture and Drug Susceptibility testing instruments including reagents, consumables, service and maintenance for a period of five (5) years at National Health Laboratory Service Nationally. Technical Suitability: Mandatory Requirement Automated system – i.e. indicator when culture/s are positive. Comply Do Not Comply Substantiation: The bidder must submit and attach to the bid response, a proof by means of a brochure/Specification. Failure to provide information will lead to disqualification. Technical Suitability: Mandatory Requirement Must indicate end of incubation period, indicating no growth. Comply Do Not Comply Substantiation: The bidder must submit and attach to the bid response, a proof by means of a brochure/ Specification. Failure to provide information will lead to disqualification. Technical Suitability: Mandatory Requirement Be able to alert user of errors (specimens and instrument) e.g. sound or Comply Do Not Comply visual alert, or pop-up notification. Substantiation: The bidder must submit and attach to the bid response, a proof by means of brochure /Specification. Failure to provide information will lead to disqualification. Technical Suitability: Mandatory Requirement The instrument must have barcode scanning capabilities Comply Do Not Comply Substantiation: The bidder must submit and attach to the bid response, a proof by means of brochure /Specification. Failure to provide information will lead to disqualification. Technical Suitability: Mandatory Requirement Must include a calibrating mechanism Comply Do Not Comply Substantiation: The bidder must submit and attach to the bid response, a proof by means of brochure /Specification. Failure to provide information will lead to disqualification. Technical Suitability: Mandatory Requirement Must be capable of doing DST with WHO recommended critical Comply Do Not Comply concentrations for the 1st and 2nd-line TB drugs relevant in the TB program Substantiation: The bidder must submit and attach to the bid response, a proof by means of brochure /Specification. Failure to provide information will lead to disqualification. Technical Suitability: Mandatory Requirement Sputum and extrapulmonary sample types can be processed on the Comply Do Not Comply instrument. Substantiation: The bidder must submit and attach to the bid response, a proof by means of brochure /Specification. Failure to provide information will lead to disqualification. Technical Suitability: Mandatory Requirement Comply Do Not Comply Confidential of 68 RFB024/25/26: Placement of Mycobacterial Culture and Drug Susceptibility testing instruments including reagents, consumables, service and maintenance for a period of five (5) years at National Health Laboratory Service Nationally. Software updates should be installed as soon as available and at the bidder’s cost Substantiation: The bidder must submit and attach to the bid response, a proof by means of a signed letter of commitment. Failure to provide information will lead to disqualification. Technical Suitability: Mandatory Requirement The instruments must fit within the existing laboratory infrastructure. Comply Do Not Comply Substantiation: The bidder must submit and attach to the bid response, a proof by means of a signed letter of commitment. Failure to provide information will lead to disqualification. Technical Suitability: Mandatory Requirement Must be capable of interface with the NHLS Lab Information System Comply Do Not Comply (TrakCare) Substantiation: The bidder must submit and attach to the bid response, a proof by means of brochure /Specification. Failure to provide information will lead to disqualification. Technical Suitability: Mandatory Requirement Provide required liquid media and supplements for mycobacterial growth Comply Do Not Comply Substantiation: The bidder must submit and attach to the bid response, a proof by means of a signed letter of commitment. Failure to provide information will lead to disqualification. Technical Suitability: Mandatory Requirement Middleware - as per site requirements Comply Do Not Comply Substantiation: The bidder must submit and attach to the bid response, a proof by means of brochure /Specification. Failure to provide information will lead to disqualification. Technical Suitability: Mandatory Requirement Provide UPS to allow switching between power source during power failure. Comply Do Not Comply Substantiation: The bidder must submit and attach to the bid response proof by means of brochure/specification. Confidential of 68 RFB024/25/26: Placement of Mycobacterial Culture and Drug Susceptibility testing instruments including reagents, consumables, service and maintenance for a period of five (5) years at National Health Laboratory Service Nationally.

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