Medical Gas Program - Minimum Technical and Support Req. (v1).xlsx

XLSX spreadsheet 17 KB Posted

Attached to
Medical Gas Electronic Catalog (ECAT) Program Synopsis Federal contract opportunity
Solicitation number
SPE2DH-23-R-0002
Issued by
Defense Logistics Agency Troop Support Medical

About this file

This document contains the Minimum Technical and Support Requirements for a Defense Logistics Agency Troop Support Medical solicitation for a Medical Gas Electronic Catalog (ECAT) Program. The key requirements include:

The vendor must be able to offer a variety of medical gas cylinder types and sizes, as well as bulk medical gases, meeting purity standards. Vendors must certify the gases conform to USP and NF standards and are manufactured according to FDA CGMP regulations. The vendor must be able to provide support coverage for all specified government facilities within a proposed region, either as the Primary or Back-Up vendor. Back-Up vendors are evaluated on their ability to source from multiple suppliers and potentially utilize the Primary vendor's cylinders/tanks in rare situations. Vendors must certify they possess all required licensing, certifications, and insurance to distribute medical gases. The solicitation refers to a separate DHA Procedures Manual that contains additional detailed requirements.

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Other files for this federal contract opportunity

Other files attached to Medical Gas Electronic Catalog (ECAT) Program Synopsis, newest first.
File Type Posted
Minimum Required Government Facility Regional Locations.pdf PDF
DHA Procedures Manual for Medical Gases.pdf PDF
Synopsis - Medical Gas Program.pdf PDF

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BASIC REQUIREMENTS & CERTS

GOVERNMENT MINIMUM REQUIREMENTS

Minimum Requirement #DESCRIPTION OF MINIMUM REQUIREMENT AND/OR OBJECTIVEMINIMUM REQUIREMENT
B1Medical Gas Type (Cylinder)Vendors are required to offer cylinder compressed medical gases, including Medical Liquid Oxygen (USP), Medical Gaseous Oxygen (USP), Medical Liquid Nitrogen (NF), Medical Compressed Nitrogen (NF), Medical Carbon Dioxide (USP), Medical Nitrous Oxide (USP), Medical Gaseous Helium (USP), Medical Liquid Helium (USP), Argon, Hydrogen, Medical Grade Air (USP) and Compressed Air.
B1No Minimum Requirement (Objective Only)Vendors that are capable of offering dry ice (solid carbon dioxide) in either rice, pellets, and/or blocks to any of the identified minimum required facilities (Reference Solicitation Appendix B – Government Facility Regional Locations) shall be assigned a strength in the evaluation.
B2Medical Gas Purity (Cylinder)Vendors are required to offer each of the below patient medical gases at corresponding purities that are equal to or greater than those provided below: Medical Liquid Oxygen (USP) - 99.00%

Medical Gaseous Oxygen (USP) - 99.00% Medical Liquid Nitrogen (NF) - 99.00% Medical Compressed Nitrogen (NF) - 99.00% Medical Carbon Dioxide (USP) - 99.00% Medical Nitrous Oxide (USP) - 97.00%

B3Medical Gas Cylinder Sizes (Cylinder)Vendors are required to offer a variety of medical gas cylinder sizes that fully cover (see definition in below note) the required range of 400 – 8,620 liters (~14.13 – 304.41 Cubic Ft.).Cylinder sizes are often manufacturer-specific; therefore, vendors must offer a variety of cylinders +/- 100 liters (~3.53 Cubic Ft.) within the range identified above. NOTE: As it relates to the above minimum requirement, “fully covered” shall be considered providing various medical gas cylinder sizes within the require range, but without any cylinder having greater than a 100-liter gap from the next nearest size.
B4Medical Gas Type (Bulk Gas)Vendors are required to offer medical gases (for existing bulk tank usage), including Medical Liquid Oxygen (USP), Medical Gaseous Oxygen (USP), & Medical Liquid Nitrogen (NF).
B5Medical Gas Purity (Bulk Gas)Vendors are required to offer each of the below medical gases (for existing bulk tank usage) at corresponding purities that are equal to or greater than those provided below: Medical Liquid Oxygen (USP) - 99.00%

Medical Gaseous Oxygen (USP) - 99.00% Medical Liquid Nitrogen - 99.00%

C1Certification Required (Cylinder)As it relates to medical gas cylinders, the vendor must certify that they will maintain all documentation certifying the purity of the compressed gas being supplied to each Government facility.
C2Certification Required (Bulk Gas)As it relates to bulk medical gases, the vendor must certify they will provide a Certificate of Purity documenting the concentration for each bulk medical gas delivery.
C3Certification Required (Both Cylinder and Bulk Gas)As it realtes to both cylinder compressed and bulk patient medical gases, the vendor must certify that they will only offer patient medical gases that conform to the most recent specifications prescribed in the United States Pharmacopoeia (USP) and the National Formulary (NF), including standards that address quality, strength, purity, packaging, labeling, and identification, throughout the life of any resultant contract.
C4Certification Required (Both Cylinder and Bulk Gas)The vendor must certify that they (the distributor - if other than manufacturer), medical gas manufacturer, and vendor personnel that are the fillers of medical gases shall be registered with the U.S. Food and Drug Administration and all patient medical gases shall be manufactured, processed, packaged, transported, and stored according to the FDA’s Current Good Manufacturing Practice (CGMP) regulations and Title 21, Code of Federal Regulations (CFR), Parts 201, 210, 211, and 820 throughout the life of any resultant contract.

SUSTAINMENT & SUPPORT

GOVERNMENT MINIMUM REQUIREMENTS

Minimum Requirement #DESCRIPTION OF MINIMUM REQUIREMENT AND/OR OBJECTIVEMINIMUM REQUIREMENT
S1Support Region(s)As outlined in Section IV. STATEMENT OF WORK; sub-section E. PROGRAM REGIONAL STRUCTURE, of the solicitation, geographical coverage is broken out by region. A vendor submitting to compete on any (or several/all) of the regions, either as the Primary Vendor and/or Back-Up Vendor must be able to provide coverage, at a minimum, to all of the specified individual Government facilities (Reference Appendix B – Government Facility Regional Locations) under that particular region. In order to be eligible for award of a region, the vendor must be able to provide full support (i.e., support to all specified Government facilities under corresponding region), either as the Primary Vendor or Back-Up Vendor, to at least one (1) of the twelve (12) regions specified in sub-section E. of the solicitation. Vendors must provide some form of supporting documentation (i.e., supplier agreements, state licenses, location of nearby ASU locations, etc.) to substantiate location support capability of any regions they are submitting a proposal to provide support to.
(i.) Pacific RegionVendor is able to support all specified Government facilities included under this region.
(ii.) Mountain RegionVendor is able to support all specified Government facilities included under this region.
(iii.) West North Central RegionVendor is able to support all specified Government facilities included under this region.
(iv.) East North Central RegionVendor is able to support all specified Government facilities included under this region.
(v.) Mid-Atlantic RegionVendor is able to support all specified Government facilities included under this region.
(vi.) New England RegionVendor is able to support all specified Government facilities included under this region.
(vii.) West South Central RegionVendor is able to support all specified Government facilities included under this region.
(viii.) East South Central RegionVendor is able to support all specified Government facilities included under this region.
(ix.) South Atlantic RegionVendor is able to support all specified Government facilities included under this region.
(x.) Alaskan RegionVendor is able to support all specified Government facilities included under this region.
(xi.) Hawaiian RegionVendor is able to support all specified Government facilities included under this region.
(xii.) Puerto Rico RegionVendor is able to support all specified Government facilities included under this region.
S1No Minimum Requirement (Objective Only)A vendor shall be considered to have met this objective if the vendor is capable of providing support to any additional facilities/locations beyond what is required under Minimum Requirement S1 and/or is capable of providing support to all major/densely populated areas (where the majority of ordering under this program is expected to occur) within each of the individual locations (i.e., states) that make up a region and/or any/all geographic locations (i.e., any/all zip codes within a particular region(s). If a vendor is claiming to be able to meet this objective, the vendor is required to specify the extent of additional support capable of being provided within its Attachment A submission and Support Plan (further discussed under Section V. SOLICITATION PROVISIONS, sub-section B.), in addition to providing some form of supporting documentation (i.e., supplier agreements, state licenses, location of nearby ASU locations, etc.) to support this claim. Any vendor that is determined to meet any of the criteria specified under this objective will be assigned a strength in the evaluation.
S2Continuity of SupplyAs it relates specifically to medical gas cylinders, whether a manufacturer or a distributor of manufacturer-specific products, the vendor must provide consistent material to the individual facilities for which it supports under that particular region. Consistent material, as it relates to medical gas cylinders, is defined as assets on site that are all owned by the same supplier. Vendors may provide medical gas cylinder support via the use of multiple suppliers in order to support the region as a whole. However, continuity of supply must be maintained among each of the individual facilities within the awarded region(s) throughout the life of any resultant contract. Under normal circumstances, facilities will not manage and/or track and/or store the cylinders (assets) of multiple suppliers.
S2aNo Minimum Requirement (Objective Only) ***THIS OBJECTIVE IS ONLY APPLICABLE TO THE BACK-UP VENDOR ROLE***As it relates specifically to medical gas cylinder support of the Back-Up Vendor, vendors that are capable of sourcing different manufacturer-specific product (i.e., medical gas cylinders) from multiple suppliers/manufacturers, will be assigned as strength in the evaluation. Vendors capable of meeting this objective shall provide their primary and secondary and/or tertiary sources of medical gas cylinders within its Attachment C – Medical Gas Program Support Matrix submission, in addition to providing some form of supporting documentation (i.e., supplier agreements) to support this claim. Furthermore, in order to be considered as meeting this objective, vendors must be able to source the product from each of the multiple sources in a manner consistent with the above Minimum Requirement S2, where continuity of supply is able to be maintained.
S2bNo Minimum Requirement (Objective Only) ***THIS OBJECTIVE IS ONLY APPLICABLE TO THE BACK-UP VENDOR ROLE***As it relates specifically to bulk medical gas support of the Back-Up Vendor, vendors that are capable of sourcing different manufacturer-specific product (i.e., bulk gas) from multiple suppliers/manufacturers, will be assigned as strength in the evaluation. Vendors capable of meeting this objective shall provide their primary and secondary and/or tertiary sources of bulk medical gas within its Attachment C – Medical Gas Program Support Matrix submission, in addition to providing some form of supporting documentation (i.e., supplier agreements) to support this claim.
S3Cylinder RequalificationThe cylinder requalification process, including inspection, hydrostatic testing, cylinder marking, and physical reconditioning, shall be conducted in accordance with the guidance provided within “Attachment D – DHA Procedures Manual for Medical Gases”.
S3aNo Minimum Requirement (Objective Only)In very rare situations and only if requested in writing by the Contracting Officer, the Back-Up Vendor may be required to provide support by utilizing (refilling) the Primary Vendor medical gas cylinders, including refilling cylinders and performing any required maintenance of those cylinders. Prior to the Back-Up Vendor utilizing the Primary Vendors medical gas cylinders, written consent and agreement must be obtained from the Primary Vendor authorizing use and maintenance of their medical gas cylinders. Although the Primary Vendor and Back-Up Vendor are not required to provide this consent and agreeance for these very rare situations, doing so (by meeting this objective) would be assigned as a strength in the evaluation. Any distributor of covered products that claims it can meet this objective must provide a letter from the manufacturer(s) within its proposal submission that states this authorization would be granted in such situations.
S3bNo Minimum Requirement (Objective Only)In very rare situations and only if requested in writing by the Contracting Officer, the Back-Up Vendor may be required to provide support by utilizing (refilling) the Primary Vendor bulk medical gas tank, including refilling the tank(s) and performing any required corresponding maintenance. Prior to the Back-Up Vendor refilling the Primary Vendors medical gas tank, written consent and agreement must be obtained from the Primary Vendor authorizing use and any corresponding maintenance of their bulk medical gas tank. Although the Primary Vendor and Back-Up Vendor are not required to provide this consent and agreeance for these very rare situations, doing so (by meeting this objective) would be assigned as a strength in the evaluation. Any distributor of covered products that claims it can meet this objective must provide a letter from the manufacturer(s) within its proposal submission that states this authorization would be granted in such situations.
C5Certification RequiredAs it relates to any region(s) proposing to provide support to, vendors must provide certification that they possess all of the licensing and/or certifications and/or insurance required by federal, state, and local laws and regulations to manufacture (if applicable) and/or distribute medical gases per the terms of this solicitation and in accordance with the best recognized commercial practices.
C5No Minimum Requirement (Objective Only)In accordance with FAR 52.228-5, prior to performing under the resultant contract vendors must notify the Contracting Officer in writing that the required insurance has been obtained. Vendors who currently have insurance coverage for the region(s) that they are submitting a proposal to provide medical gas related support to may provide a copy of this insurance within their proposal submission. Furthermore, vendors who currently have coverage relating to the distribution of medical gases, particularly those with stronger coverage, shall be assessed as a strength in the evaluation.
C6Certification RequiredThe vendor must certify that it can and will meet all of the requirements specified within Attachment D – DHA Procedures Manual for Medical Gases.

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