OCONUS Microbiological Reagents/Culture Media for the Landstuhl Regional Medical Center (LRMC), Germany
THIS IS A PRESOLICITATION ANNOUNCEMENT ONLY. The Regional Health Contracting Office-Europe is planning to issue a Request for Quote (RFQ) for delivery of Microbiological Reagents/Culture Media for the Landstuhl Regional Medical Center (LRMC). The resultant contract type will be a Firm-Fixed-Price (FFP) Purchase Order. It is incumbent upon interested parties to review this site frequently for any updates/amendments to any and all documents. Purchase Order will be issued lowest price and technically acceptable quote. The RFQ will be issued for full and open competition. All vendors must be registered in the System for Award Management (SAM) prior to award, and lack of registration shall make a quotation ineligible for award. Vendors may obtain information on registration and annual confirmation requirements by calling 1-866-606-8220 or via Internet at https://www.sam.gov. QUOTE SUBMISSION 1. INSTRUCTION a. ELECTRONIC Quote. Quoters may submit electronic quote in response to this Request for Quote. The quote must be received by the quote due date/local time as specified in block 8 of the SF 1449 cover page to the inbox of the following email address: henningfalk.mayer-goldstein.ln@health.mil. Vendors may call Mr. Henning Mayer-Goldstein at +49 (6371) 9464 6789 to verify receipt of the quote. If the vendor choses to email the quote, the Government will not be responsible for any failure of transmission or receipt of the quote, or any failure of the vendor to verify receipt of the emailed quote. b. FORMAT and SIZE: Each paragraph shall be separated by at least one blank line. A standard, 12-point minimum font size applies. Margins: Top, Bottom, Left, Right – 1” Page Size, Width – 8.5” Page Size, Height – 11” or DIN A4 size. Tables and illustrations may use a reduced font size not less than 8-point and may be landscape. Page size 11x17 or DIN A3 size may be used where needed for readability, however, each printed side of an 11x17 or A3 size page will count as two pages Page limitations shall be treated as maximums. If exceeded, the excess pages will not be read or considered in the evaluation of the quote and (for paper copies) will be returned to the quoter as soon as practical. The technical quote shall address how you will comply with the requirements set forth in the PWS and must clearly explain each of the technical subfactors as shown in paragraph (4) above. The following is excluded from the page count: copies of certificates, price schedule, completed FAR 52.212-3 Quoter Representations and Certifications – Commercial Items, and acknowledgement of any amendments issued. c. Page Limitations. Page limitations shall be treated as maximums. Pages in excess of the below limitations will be removed and disregarded during the evaluation. When both sides of a sheet display printed material, it shall be counted as two pages. Each page shall be counted except the following: covers, tab dividers, title pages, glossaries, and table of contents/file index. Also, page limits are applicable to legible tables, charts, graphs and figures used wherever practical to depict organizations, implementation schedules, plans, etc. The quote shall consist of the following sections and be limited by the maximum page limit. Section # Section Title Maximum Page Limit per Section Section 1 Factor 1 – Technical 20 pages Section 2 Factor 2 – Total Price on 2 pages SF 1449 (completed and signed) and itemized prices in Exhibit A – Schedule of Estimated Items (in addition to the SF 1449) d. QUESTIONS. Prospective quoters are strongly encouraged to submit any questions regarding this Request for Quote no later than five (5) business days prior to the request for quote due date specified in block 8 of the SF 1449 cover page. Questions can be emailed to Mr. Henning Mayer-Goldstein at henningfalk.mayer-goldstein.ln@health.mil. All questions received will be answered officially tough an amendment to the Request for Quote for distribution to all prospective quoters. Questions received after the CET cut-off date/time will not be accepted by the Government. FACTOR 1 – TECHNICAL: Quoter shall demonstrate compliance with the requirements in the solicitation by submitting a written quote which addresses compliance with each of the following technical subfactors and salient characteristics: SUBFACTOR 1: a. The Offeror shall provide proof of compliance that the offered microbiological culture media listed in Technical Exhibit A, or equal items, comply with the following: - Code of Federal Regulations (CFR) Part 820, Subpart H. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820/subpart-H - CFR Sec. 820.120 Device labeling; https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820/subpart-K/section-820.120 - CFR Sec. 820.130 Device packaging; https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820/subpart-K/section-820.130 - CFR Sec. 820.140 Handling; https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820/subpart-L/section-820.140 - CFR Sec. 820.150 Storage; https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820/subpart-L/section-820.150 - CFR Sec. 820.160 Distribution. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820/subpart-L/section-820.160 b. The Offeror shall provide proof of compliance to provide each delivered box or sleeve of medium the following information: - the medium type - formulation - lot number - expiration date - appropriate handling - storage conditions c. The Offeror shall provide proof of compliance to provide technical information indicating basic specifications, general information, recommended uses, media formulations, contamination level, pH, pour depth, volume dispensed, presence/absence of nonviable contaminants, performance criteria to include testing to detect gross contamination, organisms used for growth checks and the expected reactions to include any growth variables including acceptance criteria for each medium type. d. The Offeror shall provide proof of compliance indicating that labeled specifications for medium storage and handling were sustained during storage at the point of manufacturer and during distribution before and during delivery to the user. The Offeror shall provide documentation to users upon request. e. The Offeror shall provide proof of compliance ensuring that media created/delivered is free from cracked or damaged plates, agar detachment from plates, frozen or melted agar, unequal filling of plates, hemolysis for blood containing media, changes in the expected color of the plates, excessive bubbles or rough surfaces, excessive moisture or dehydration, obvious contamination and presence of precipitates. f. The Offeror shall provide proof of compliance stating replacement media/reagents will be provided if the shipped media does not comply with Subfactor 2 Paragraph 5. SUBFACTOR 2: a. The Offeror shall provide a statement of compliance ensuring that a Certificate of Compliance or Quality Control Certificate will be provided for each lot number of items listed in Technical Exhibit A-1, or equal items, in accordance with CLSI standard M22-A3, Table 2, https://www.clsi.org (Clinical and Laboratory Standards Institute), Attachment # 1. b. The Offeror shall provide proof of compliance stating all products received shall meet or exceed all requirements of CLSI publications: - M22-A3 Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard—Third Edition - M02 Performance Standards for Antimicrobial Disk Susceptibility Tests, 13th Edition SUBFACTOR 3: The Offeror shall provide a statement of compliance for item #261191 in Technical Exhibit A, or equal items, stating individual sterile, contaminant-free vials of 10% or 20% potassium hydroxide (KOH) solution has been specifically designed to reduce or eliminate keratinaceous material in microscopic preparations for the visual detection of fungal elements in human tissue. SUBFACTOR 4: The Offeror shall provide a statement of compliance for items #443712 and #435719 in Technical Exhibit A, or equal items, proving compatibility with the current analyzer, BD MAX™, for the detection of common bacterial, fungal, and parasitic vaginal pathogens. SUBFACTOR 5: The Offeror shall provide a statement of compliance stating that routine call orders shall be delivered at a minimum, within 3 business days. SUBFACTOR 6: The Offeror shall submit a written narrative to explain its corporate capability to supply the medical items that the U.S. Government will order. FACTOR 2 – PRICE: The quoter shall ensure to provide the offered prices on the Standard Form (SF) 1449 and comply with the following: (1) The quoter shall provide a unit price and extended amount (i.e., quantity multiplied by unit price) shall be submitted for each item listed on Exhibit A – Schedule of Estimated Items. The unit price takes precedence in case of a discrepancy. (2) The quoter shall limit their prices to two decimal places (example: $3.45 or €3.45). ACQUISITION PROCEDURE This is a commercial item under FAR Part 12 and the acquisition procedures to be used for this purchase will be in accordance with FAR Part 13.5, Simplified Procedures for Certain Commercial Products and Commercial Services. SPECIAL NOTE: All vendors must be registered in the System for Award Management (SAM) prior to award, and lack of registration shall make a quote ineligible for award. Vendors may obtain information on registration and annual confirmation requirements by calling 1-866-606-8220 or via Internet at https://www.sam.gov.
W9114F22Q0089 Department of the Army Medical Command
8/26/22, 12:59 PM OCONUS Microbiological Reagents/Culture Media for the Landstuhl Regional Medical Center (LRMC), Germany
The Regional Health Contracting Office-Europe issued a Request for Quote (RFQ) for delivery of Microbiological Reagents/Culture Media for the Landstuhl Regional Medical Center (LRMC). The resultant contract type will be a Firm-Fixed-Price (FFP) Purchase Order. It is incumbent upon interested parties to review this site frequently for any updates/amendments to any and all documents. Purchase Order will be issued lowest price and technically acceptable quote. The RFQ will be issued for full and open competition. All vendors must be registered in the System for Award Management (SAM) prior to award, and lack of registration shall make a quotation ineligible for award. Vendors may obtain information on registration and annual confirmation requirements by calling 1-866-606-8220 or via Internet at https://www.sam.gov. QUOTE SUBMISSION 1. INSTRUCTION a. ELECTRONIC Quote. Quoters may submit electronic quote in response to this Request for Quote. The quote must be received by the quote due date/local time as specified in block 8 of the SF 1449 cover page to the inbox of the following email address: henningfalk.mayer-goldstein.ln@health.mil. Vendors may call Mr. Henning Mayer-Goldstein at +49 (6371) 9464 6789 to verify receipt of the quote. If the vendor choses to email the quote, the Government will not be responsible for any failure of transmission or receipt of the quote, or any failure of the vendor to verify receipt of the emailed quote. b. FORMAT and SIZE: Each paragraph shall be separated by at least one blank line. A standard, 12-point minimum font size applies. Margins: Top, Bottom, Left, Right – 1” Page Size, Width – 8.5” Page Size, Height – 11” or DIN A4 size. Tables and illustrations may use a reduced font size not less than 8-point and may be landscape. Page size 11x17 or DIN A3 size may be used where needed for readability, however, each printed side of an 11x17 or A3 size page will count as two pages Page limitations shall be treated as maximums. If exceeded, the excess pages will not be read or considered in the evaluation of the quote and (for paper copies) will be returned to the quoter as soon as practical. The technical quote shall address how you will comply with the requirements set forth in the PWS and must clearly explain each of the technical subfactors as shown in paragraph (4) above. The following is excluded from the page count: copies of certificates, price schedule, completed FAR 52.212-3 Quoter Representations and Certifications – Commercial Items, and acknowledgement of any amendments issued. c. Page Limitations. Page limitations shall be treated as maximums. Pages in excess of the below limitations will be removed and disregarded during the evaluation. When both sides of a sheet display printed material, it shall be counted as two pages. Each page shall be counted except the following: covers, tab dividers, title pages, glossaries, and table of contents/file index. Also, page limits are applicable to legible tables, charts, graphs and figures used wherever practical to depict organizations, implementation schedules, plans, etc. The quote shall consist of the following sections and be limited by the maximum page limit. Section # Section Title Maximum Page Limit per Section Section 1 Factor 1 – Technical 20 pages Section 2 Factor 2 – Total Price on 2 pages SF 1449 (completed and signed) and itemized prices in Exhibit A – Schedule of Estimated Items (in addition to the SF 1449) d. QUESTIONS. Prospective quoters are strongly encouraged to submit any questions regarding this Request for Quote no later than five (5) business days prior to the request for quote due date specified in block 8 of the SF 1449 cover page. Questions can be emailed to Mr. Henning Mayer-Goldstein at henningfalk.mayer-goldstein.ln@health.mil. All questions received will be answered officially tough an amendment to the Request for Quote for distribution to all prospective quoters. Questions received after the CET cut-off date/time will not be accepted by the Government. FACTOR 1 – TECHNICAL: Quoter shall demonstrate compliance with the requirements in the solicitation by submitting a written quote which addresses compliance with each of the following technical subfactors and salient characteristics: SUBFACTOR 1: a. The Offeror shall provide proof of compliance that the offered microbiological culture media listed in Technical Exhibit A, or equal items, comply with the following: - Code of Federal Regulations (CFR) Part 820, Subpart H. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820/subpart-H - CFR Sec. 820.120 Device labeling; https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820/subpart-K/section-820.120 - CFR Sec. 820.130 Device packaging; https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820/subpart-K/section-820.130 - CFR Sec. 820.140 Handling; https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820/subpart-L/section-820.140 - CFR Sec. 820.150 Storage; https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820/subpart-L/section-820.150 - CFR Sec. 820.160 Distribution. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820/subpart-L/section-820.160 b. The Offeror shall provide proof of compliance to provide each delivered box or sleeve of medium the following information: - the medium type - formulation - lot number - expiration date - appropriate handling - storage conditions c. The Offeror shall provide proof of compliance to provide technical information indicating basic specifications, general information, recommended uses, media formulations, contamination level, pH, pour depth, volume dispensed, presence/absence of nonviable contaminants, performance criteria to include testing to detect gross contamination, organisms used for growth checks and the expected reactions to include any growth variables including acceptance criteria for each medium type. d. The Offeror shall provide proof of compliance indicating that labeled specifications for medium storage and handling were sustained during storage at the point of manufacturer and during distribution before and during delivery to the user. The Offeror shall provide documentation to users upon request. e. The Offeror shall provide proof of compliance ensuring that media created/delivered is free from cracked or damaged plates, agar detachment from plates, frozen or melted agar, unequal filling of plates, hemolysis for blood containing media, changes in the expected color of the plates, excessive bubbles or rough surfaces, excessive moisture or dehydration, obvious contamination and presence of precipitates. f. The Offeror shall provide proof of compliance stating replacement media/reagents will be provided if the shipped media does not comply with Subfactor 2 Paragraph 5. SUBFACTOR 2: a. The Offeror shall provide a statement of compliance ensuring that a Certificate of Compliance or Quality Control Certificate will be provided for each lot number of items listed in Technical Exhibit A-1, or equal items, in accordance with CLSI standard M22-A3, Table 2, https://www.clsi.org (Clinical and Laboratory Standards Institute), Attachment # 1. b. The Offeror shall provide proof of compliance stating all products received shall meet or exceed all requirements of CLSI publications: - M22-A3 Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard—Third Edition - M02 Performance Standards for Antimicrobial Disk Susceptibility Tests, 13th Edition SUBFACTOR 3: The Offeror shall provide a statement of compliance for item #261191 in Technical Exhibit A, or equal items, stating individual sterile, contaminant-free vials of 10% or 20% potassium hydroxide (KOH) solution has been specifically designed to reduce or eliminate keratinaceous material in microscopic preparations for the visual detection of fungal elements in human tissue. SUBFACTOR 4: The Offeror shall provide a statement of compliance for items #443712 and #435719 in Technical Exhibit A, or equal items, proving compatibility with the current analyzer, BD MAX™, for the detection of common bacterial, fungal, and parasitic vaginal pathogens. SUBFACTOR 5: The Offeror shall provide a statement of compliance stating that routine call orders shall be delivered at a minimum, within 3 business days. SUBFACTOR 6: The Offeror shall submit a written narrative to explain its corporate capability to supply the medical items that the U.S. Government will order. FACTOR 2 – PRICE: The quoter shall ensure to provide the offered prices on the Standard Form (SF) 1449 and comply with the following: (1) The quoter shall provide a unit price and extended amount (i.e., quantity multiplied by unit price) shall be submitted for each item listed on Exhibit A – Schedule of Estimated Items. The unit price takes precedence in case of a discrepancy. (2) The quoter shall limit their prices to two decimal places (example: $3.45 or €3.45). ACQUISITION PROCEDURE This is a commercial item under FAR Part 12 and the acquisition procedures to be used for this purchase will be in accordance with FAR Part 13.5, Simplified Procedures for Certain Commercial Products and Commercial Services. SPECIAL NOTE: All vendors must be registered in the System for Award Management (SAM) prior to award, and lack of registration shall make a quote ineligible for award. Vendors may obtain information on registration and annual confirmation requirements by calling 1-866-606-8220 or via Internet at https://www.sam.gov.
W9114F22Q0089 Department of the Army Medical Command
8/29/22, 4:41 AM