SPE2D120R001 Solicitation.pdf
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- Noncommercial Medical Equipment (NCME) Program Federal contract opportunity
- Solicitation number
- SPE2D1-20-R-0001
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| File | Type | Posted |
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| SF30_SPE2D120R00010001.pdf | ||
| Amendment 0002.pdf | ||
| SF30_SPE2D120R00010003.PDF |
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Text version
10. FOR
INFORMATION
CALL:
13. DISCOUNT FOR PROMPT PAYMENT
(See Section I, Clause No. 52.232-8)
SOLICITATION, OFFER AND AWARD 1. THIS CONTRACT IS A RATED ORDER
UNDER DPAS (15 CFR 700)
RATING
2. CONTRACT No.
SPE2D1-20-R-0001
3. SOLICITATION No. 4. TYPE OF SOLICITATION
SEALED BID (IFB)
NEGOTIATED (RFP)X
2020 OCT 23
5. DATE ISSUED
1000023111
6. REQUISITION/PURCHASE No.
7. ISSUED BY 8. ADDRESS OFFER TO
NOTE : In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".
9. Sealed offers in original and copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in local time
CAUTION - LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.
11. TABLE OF CONTENTS
DESCRIPTION
25. PAYMENT WILL BE MADE BY
CODE
SOLICITATION
until (Hour) (Date)
AUTHORIZED FOR LOCAL REPRODUCTION
PREVIOUS EDITION NOT USABLE
STANDARD FORM 33 (Rev.9-97) Prescribed by GSA FAR (48 CFR) 53.214 (c)
OFFER (Must be fully completed by offeror ) NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.
AWARD (To be completed by Government)
16. NAME AND TITLE OF PERSON AUTHORIZED TO SIGN OFFER
(Type or print)
14. ACKNOWLEDGMENT OF AMEND-
MENTS (The offeror acknowledges receipt of amendments to the SOLICITATION for offerors and related documents numbered and dated):
12. In compliance with the above, the undersigned agrees, if this offer is accepted within period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.
CONTRACT ADMINISTRATION DATA L INSTRS., CONDS., AND NOTICES TO OFFERORS
SPECIAL CONTRACT REQUIREMENTS M EVALUATION FACTORS FOR AWARD
IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice.
(X) PAGE(S) SEC. DESCRIPTION PAGE(S)
SUPPLIES OR SERVICES AND PRICES/COSTS PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.
PART I - THE SCHEDULE PART II - CONTRACT CLAUSES
I CONTRACT CLAUSESSOLICITATION/CONTRACT FORM
DESCRIPTION/SPECS./WORK STATEMENT J LIST OF ATTACHMENTS
INSPECTION AND ACCEPTANCE
PACKAGING AND MARKING PART IV - REPRESENTATIONS AND INSTRUCTIONS
DELIVERIES OR PERFORMANCE
K REPRESENTATIONS, CERTIFICATIONS AND OTHER
STATEMENTS OF OFFERORS
AMENDMENT NO. DATEAMENDMENT NO. DATE
G
H
SEC.
B
A
C
E
D
F
(X)
FACILITY
CODE
15C. CHECK IF REMITTANCE ADDRESS IS
DIFFERENT FROM ABOVE - ENTER SUCH
ADDRESS IN SCHEDULE
17. SIGNATURE
19. ACCEPTED AS TO ITEMS NUMBERED
23. SUBMIT INVOICES TO ADDRESS SHOWN IN22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:
24. ADMINISTERED BY (If other than item 7) CODE CODE
27. UNITED STATES OF AMERICA
(Signature of Contracting Officer )
26. NAME OF CONTRACTING OFFICER (Type or print) calendar days (60 calendar days unless a different
15A. NAME AND
ADDRESS
OF OFFER-
OR
10 U.S.C. 2304 (c) ( 41 U.S.C. 253 (c) () )
DLA TROOP SUPPORT
MEDICAL SUPPLY CHAIN FSD
700 ROBBINS AVENUE
PHILADELPHIA PA 19111
USA
See Continuation Sheet
Business Opportunities Office, Building 45-C-167 3:00PM 2028-May-15
Felix Mercado-Adames PDPSHA4
A. NAME
Phone: 215-737-5762
FAX: 215-737-5752
B. PHONE/FAX (NO COLLECT CALLS)
Felix.Mercado.Adames@dla.mil
C. EMAIL ADDRESS
X 1
15B. TELEPHONE NUMBER 18. OFFER DATE
28. AWARD DATE
20. AMOUNT
10 CALENDAR DAYS (%) 20 CALENDAR DAYS (%) CALENDAR DAYS (%)30 CALENDAR DAYS (%)
21. ACCOUNTING AND APPROPRIATION
ITEM
SPE2D1
EXT.NUMBERAREA CODE
(4 copies unless otherwise specified)
CONTINUATION SHEET REFERENCE NO. OF DOCUMENT BEING CONTINUED: PAGE 2 OF 73 PAGES
CONTINUED ON NEXT PAGE
SPE2D1-20-R-0001
SECTION B - SUPPLIES OR SERVICES AND PRICES OR COSTS
CONTINUATION PAGES- SPE2D120R0001
PART I - THE SCHEDULE
SECTION A - SOLICITATION/CONTRACT FORM (CONTINUATION)
Blocks 8
Vendors must submit their offers electronically by uploading all required proposal documents by the solicitation closing time/date on the DLA Internet Bid Board System (DIBBS) at https://www.dibbs.bsm.dla.mil
Block 9
Offer Due Date/Local Time: The initial solicitation closing date shall be December 30, 2020; 1:00 pm, Local Philadelphia Time. Vendors must submit their offers electronically by uploading all required proposal documents by the solicitation closing time/date on the DLA Internet Bid Board System (DIBBS) at https://www.dibbs.bsm.dla.mil.
https://www.dibbs.bsm.dla.mil
CONTINUATION SHEET REFERENCE NO. OF DOCUMENT BEING CONTINUED: PAGE 3 OF 73 PAGES
SECTION B - SUPPLIES OR SERVICES AND PRICES OR COSTS (CONTINUED)
There will be at least one subsequent open season, where the solicitation will be reopened to allow additional vendors to join the program, that will be issued via posting of an amendment on DIBBS and the Government Point of Entry (GPE) website. The Government reserves the right to have additional open seasons that would be issued via DIBBS and the GPE. Offers may be submitted at any time during the initial solicitation period or open season(s). Acceptance and evaluation of offers may take place before the actual closing date.
Mailed, hand carried, faxed, or emailed offers are unacceptable and shall not be accepted.
E-mail or fax transmissions may be authorized in writing by the Contracting Officer for negotiations and any offer revisions. If negotiations take place or a request for proposal Amendment is issued, the method and date/time for receipt of vendor submissions will be provided by the Contracting Officer.
If the ability to upload proposals is unavailable for any reason, this does not constitute an acceptable reason for a late offer. If experiencing any upload issues, please contact the solicitation POC immediately for further instructions.
Vendors are strongly encouraged to submit offers well in advance of the closing date/time as last-minute system issues may not be resolved in time to allow a vendor to submit an offer and to be considered for this solicitation.
Vendors should familiarize themselves with and log into DIBBS well in advance of submitting their offer.
Block 15c
Remittance Address: (if different from Contractor/Offeror address in block 15a of the SF33.)
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS
The Defense Logistics Agency Troop Support Medical Supply Chain (DLA) is responsible for the acquisition and management of a full line of medical items for customers located in the United States and worldwide. The objective of this solicitation is to establish the second generation of the Noncommercial Medical Equipment (NCME) Program with multiple-award Indefinite Delivery/Indefinite Quantity (IDIQ) contracts utilizing FAR 16.505 multiple-award ordering procedures. The NCME program shall support noncommerical medical equipment. Additionally, the program shall support procurement of components, training, repair parts, consumables, accessories and incidental services related to the supply of noncommercial medical equipment. This program is a renewal of the Nondevelopmental Oxygen Systems program and expands the scope to support all other noncommercial medical equipment product categories that can be supported by DLA Troop Support.
CONTINUATION SHEET REFERENCE NO. OF DOCUMENT BEING CONTINUED: PAGE 4 OF 73 PAGES
SPE2D1-20-R-0001
SECTION B - SUPPLIES OR SERVICES AND PRICES OR COSTS (CONTINUED)
Recent historical sales data for Oxygen Systems have been approximately $17.8 million per year. The total program estimate is anticipated to increase in sales as the program expands to new product lines.
Guaranteed Minimum Dollar Value: The Guaranteed minimum dollar value shall be $4,000 per contract.
Maximum Dollar Value: No individual contract maximum under this standing solicitation will exceed $356 Million.
The Maximum Dollar Value for each individual contract under this solicitation will be assigned by the government based on past history of Government sales and/or Government projections of potential sales, including allowing for surge capacity and unforeseen requirements.
Term: This solicitation is proposed to establish Indefinite-Delivery Indefinite-Quantity contracts for the offered items. All contracts shall have a five-year base period and a single option to extend contracts for an additional five-year term.
SECTION C - DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK
I. CONTRACT SCOPE
(a.) This solicitation provides for the supply of noncommercial medical equipment and noncommercial nondevelopmental medical equipment. Additionally, the program shall support procurement of components, training, repair parts, consumables, accessories, networking/interfacing, upgrades, software, and incidental services related to the supply of noncommercial medical equipment.
(b.) This program is based on the Nondevelopmental Oxygen Systems program and envisions supporting additional noncommercial medical equipment and noncommercial nondevelopmental medical equipment product groups.
(c.) All end product medical systems, devices or equipment must be noncommercial at time of initial contract award to be determined in scope of the program. If the equipment is offered by an existing NCME contract holder for contract addition, the item must be noncommercial at the time of addition to the contract, to be determined in scope of the program. If a medical system, device or equipment; along with components, training, repair parts, consumables, accessories, networking/interfacing, upgrades, software, and incidental services; change from noncommercial to commercial during the life of the contract, the item can remain for the duration of the contract term, and will remain in the scope of the contract. However, FAR 12 procedures will not be applied to such an item that becomes a commercial item after contract award or contract addition. Any end product medical system, device or equipment that is determined to be commercial prior to award or addition to the contract shall be determined out of scope and not allowed under the NCME Program.
(d.) Any components, training, repair parts, consumables, accessories, networking/interfacing, upgrades, software, and incidental services for end product medical systems, devices or equipment that the vendor has on contract or previously had on a contract awarded under this Solicitation are in scope of this program. Such items may be either noncommercial or commercial. In the event the item is commercial, clause 52.212-4 Contract Terms and Conditions --Commercial Items shall apply for such items along with all other clauses and language in the solicitation. FAR 52.212-4 only applies to delivery orders or the portions of delivery orders for commercial components, accessories, etc. and does not apply to the base contract.
CONTINUATION SHEET REFERENCE NO. OF DOCUMENT BEING CONTINUED: PAGE 5 OF 73 PAGES
(e.) Incidental services are services that the contractor may be asked to perform in connection with supplying items under the scope of the contract. What constitutes an incidental service is fact specific and will be a function of factors such as type of service, amount charged for the service, dollar amount charged for the supplies, existence of a close relationship between the service and the item supplied, and the time required to perform the service.
II. AUTHORITY TO ISSUE ORDERS
(a.) The Defense Logistics Agency Troop Support Medical Supply Chain (DLA) is the only activity authorized to place delivery orders under any resulting IDIQ contract. In rare instances DLA may delegate ordering authority to other Department of Defense organizations, if approved in writing by the DLA Contracting Officer. Any delegation may be rescinded unilaterally at any time through written notice to vendors.
(b.) Orders may be issued in support of requirements from the Department of Defense (DoD), other Federal Agencies/ Organizations and foreign governments through the DoD foreign military sales programs. During the term of the contract DLA reserves the right to add other customer groups to be supported by this IDIQ contract.
III. CONTRACT LIMITATIONS
(a.) Maximum Contract Limitation.
A contract maximum shall be established by the Government for each individual contract under this solicitation and will be assigned by the government based on past history of Government sales and/or Government projections of potential sales, including allowing for surge capacity and unforeseen requirements. This single maximum contract limitation shall apply for life of the contract, including the base year and all option years, if exercised. However, no single contract maximum shall exceed the program estimated value of $356 million.
(b.) Guaranteed Minimum.
The Guaranteed minimum dollar value shall be $4,000 per contract. The Government may fulfill the guarantee by a single delivery order or by any number of delivery orders during the contract base period and/or the option period, if exercised.
IV. CONTRACT BASE AND OPTION PERIODS
All contracts shall have a five-year base period and a single option to extend contracts for an additional five-year term.
V. EQUIPMENT REQUIREMENTS
(a.) AVAILABILITY OF PARTS AND SERVICE
The vendor shall ensure servicing and replacement parts are available, and that it is able to provide the parts for a period of five years after final acceptance.
CONTINUATION SHEET REFERENCE NO. OF DOCUMENT BEING CONTINUED: PAGE 6 OF 73 PAGES
(b.) MANUALS AND PHONE SUPPORT
Vendor shall provide one paper copy Operator Manual and Maintenance/Service Manual, along with a CD ROM/ DVD version of the manuals with each system. The manuals shall enable a user to safely operate and maintain the vendors system. If the operator manual and/or maintenance manual is not sufficient for training a first-time user of the system, the vendor shall provide supplemental paper instructions. The vendor shall also provide a Technical Support Line Access (24 hours, 7 days a week) to assist users with operation and maintenance questions.
(c.) ALL OTHER TRAINING
The Contractor shall offer on-site training as a contract offering, that customers may purchase separately if needed.
This training shall include operation, maintenance of equipment, protocol installation, and actual demonstration and operation of the equipment including any adjustments or other actions which may be undertaken by operating personnel in the event of equipment failure, provided that such adjustment or action will in no way jeopardize the Government's rights under contract warranty provisions.
Additional Training may be offered for Government consideration at the time a proposal is submitted or for addition after initial contract award. On delivery orders training shall be listed under its own delivery order line item, unless provided at no additional charge to the Government.
Offered maintenance training should be equivalent to what the contractor's (Original Equipment Manufacturer) service/repair personnel receive and should include all prerequisite classes. All service manuals, schematics, diagrams, diagnostic software, other special tools and hardware keys equivalent to what the contractor service/repair personnel have available to diagnose, troubleshoot, repair and maintain the equipment should be provided with the training. The training must be consistent with the other terms of the contract
(d.) APPLICATION SOFTWARE AND OPERATING SYSTEM REQUIREMENTS
Application software (e.g. physiological data and image acquisition, manipulation, reconstruction, analysis, display, etc.), and any Off the Shelf commercial Operating System (OS) necessary for operation and maintenance of the system being purchased, are to be provided by the contractor. The OS must be the latest major release currently available for purchase in the commercial marketplace or no older than one release prior to the latest major release.
Older releases may be considered acceptable if authorized in writing by the requesting facility and approved by the Contracting Officer. Application software updates compatible with the offered system's hardware shall be kept current at no additional cost to the Government as long as the equipment is in use in accordance with the Statement of Work.
For the purpose of this clause, updates are defined as all modifications to correct or improve system operation and current functions including known remedies for security vulnerabilities and shall be provided to the Government at no additional cost.
Upgrades are defined as providing additional functions and shall be made available for purchase at the Government's election.
Updates that are bundled with upgrades shall be provided at no additional cost. The contractor may restrict added upgrade functions if restriction does not limit existing functions.
Modifications of software by the Government will not be made without prior consent of contractor.
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The Government shall be able to reinstall vendor application software and operating systems (OS) on new hardware if the original hardware on which such software was installed fails.
Software and commercial OS provided must not be self-canceling, which is interpreted to mean that the function of the software will not be stopped due to elapsing time or other condition not identified with the original equipment purchase. The prime contractor is responsible to ensure any third-party provided software is included in this restriction. No “renewable” licenses or agreements will be entered into by either the Contracting Officer or the using facility.
Additionally, the Government shall have networking rights for all commercial computer software that it acquires through contracts and orders for equipment awarded under this solicitation. The Government shall be the licensee. All such software acquired shall be for a perpetual duration.
(e.) HARDWARE UPGRADES
(1.) All equipment and related peripherals contracted for shall be state-of-the-art technology. "State-of-the-art" is defined as the most recently designed components which are available, maintained and supported in accordance with requirements specified in the solicitation. Components and products with a manufacturer's planned obsolescence within one year of the initial offer expiration date when first submitting a proposal under the program solicitation or one year from the contract addition request date when adding items to an existing contract are not acceptable. For existing contract items, vendors are required to immediately notify the Contracting Officer when it is known that an item will become obsolete, provide the estimated obsolescence date, and disclose the obsolescence date in all offers. It should be noted that obsolescence of the system does not relieve the vendor of compliance with other terms for already purchased systems such requirements for repair parts availability, updates, etc.
(2.) If hardware upgrades become available after award of a delivery order, but prior to delivery and/or installation of the equipment, the contractor is required to inform the Contracting Officer who will determine whether or not the Government will agree to the upgrade.
(3.) The contractor's proposal for such upgrades shall include the following information:
(i) Pricing information, to include both the price of the equipment to be added and the equipment to be deleted.
(ii) Specific awarded items which shall be changed if the offer is awarded.
(iii) Performance data, including both comparison to the specification requirements and to the equipment on contract.
(iv) A detailed description of the differences between the awarded items and those being proposed, and a specific analysis of the comparative advantages/ disadvantages of the items involved.
(v) An evaluation of the effect proposed changes will have on the life cycle of the equipment and an associated cost impact as it relates to site preparation, installation, maintenance, and operational expense.
(vi) An analysis of the timeframe required to institute the change.
(f.) SERVICE BULLETINS
Service bulletins affecting safety, effectiveness, functionality, and/ or maintenance of equipment furnished under this contract shall be emailed to the receiving activity for the entire expected life of the product or a period of eight years from the date of delivery, whichever is longer.
Service bulletins as well as any other special communications, such as, but not limited to, hazard alerts, safety notices, end-of-life notifications, and/or any other manufacturers' letters shall be emailed to the Contracting Officer for the
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SPE2D1-20-R-0001
SECTION B - SUPPLIES OR SERVICES AND PRICES OR COSTS (CONTINUED)
basic contract and all POC's on any issued delivery orders. When applicable, this shall occur within FDA established timeframes from the date of a recall.
(g.) PRODUCT CORRECTION, REMOVAL OR RECALL
If any product awarded under this solicitation requires correction as defined by FDA, is removed or recalled by the contractor or manufacturer due to defects in the product or potential dangers to patients, or if correction, removal or recall is suggested or mandated by a regulatory or official agency, the following steps will immediately be taken by the contractor or manufacturer:
(1.) All the following offices and points of contact should be emailed or mailed a notification:
(i) Each individual Customer POC on the referenced order and other regular Facility POC's
(ii) DLA Contracting Officer and Biomedical Engineer cited in the delivery order.
(iii) DoD Service Recall POC
(2.) The following information must be provided in each individual notification that is forwarded to all above offices and points of contact:
(i) Complete item description and/or identification, the contract number and delivery order numbers
(ii) Reasons for correction, removal or recall.
(iii) Proposed offers for return for credit, replacement or corrective action shall be forwarded to the facility POC and Contracting Officer, for consideration by the Government.
(3.) The vendor will be responsible for all costs associated with a recall.
(h.) REPAIR PARTS, ACCESSORIES, CONSUMABLES, AND TOOLS
(1.) The contractor shall guarantee that the Government will be able to purchase all required repair (spare) parts, accessories, consumables and tools needed to operate and maintain a system, from the contractor for a minimum of five years from the date of final system acceptance. The vendor must include all such items in their contract that are TAA clause compliant. Repair parts are defined as end products/items that will be procured on their own after system has been purchased and used to replace items that have failed or must be replaced to keep the system operational.
Tools include repair tools, calibration tools, and any other tools needed to operate and maintain the system. All repair parts, accessories, consumables, and tools that are end products from Trade Agreement Act (TAA) Clause compliant countries; including U.S.-made end products, qualifying country end products and designated country end products as defined by DFARS 252.225-7021 Trade Agreements must be offered as part of the vendor's contract. The items must comply with all other terms and conditions in this solicitation, including Berry Amendment Compliance.
(2.) Vendor shall provide a full listing of all repair parts, accessories, consumables, and tools (must include a description, weight, dimensions, Country of Origin, and price) and distinguish the items to be considered high-failure repair parts (identified by Original Equipment Manufacturer (OEM) and Government). The list shall be updated and maintained for the life of the contract.
(3.) For repair parts, accessories, consumables and tools that are not TAA Clause compliant, the vendor must provide them in the above referenced repair parts list and agree to provide an updated list of non-TAA Clause compliant repair parts for the life of the contract. Non-TAA Clause compliant repair items will not be added to the vendor's
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SECTION B - SUPPLIES OR SERVICES AND PRICES OR COSTS (CONTINUED)
contract. The vendor shall agree that if any items become TAA Clause compliant during the life of the contract, then the vendor shall immediately notify the Government and request that they be added to the contract.
(i.) SUSTAINMENT PLANNING SUPPORT: The vendor shall support Government planning for the sustainment of the systems. This shall include being available to discuss with Government users how to best deploy, maintain, operate the systems, and any other considerations. This shall include providing the Government needed information and data needed to plan out the life-cycle support of the system.
VI. INFORMATION TECHNOLOGY REQUIREMENTS
DEPARTMENT OF DEFENSE (DOD) CYBERSECURITY, RISK MANAGEMENT FRAMEWORK (RMF),
AND/OR SERVICE INFORMATION ASSURANCE (IA) REQUIREMENTS (ONLY ORDERS FOR DOD
CUSTOMERS)
NOTE: For the purposes of this solicitation; Cybersecurity, RMF, and IA requirements are used synonymously to refer to the same set of DoD Cybersecurity regulations and policies.
All DoD requirements for equipment that has an operating system or the capability to be connected to a network shall be required to meet DoD Cybersecurity and individual Military Service IA/RMF requirements. DoD Cybersecurity and Service specific IA/RMF requirements mandate that equipment must receive an Authorization to Operate (ATO) prior to being able to be connected to any DoD network. ATO is Service specific, so reciprocity is dependent on which Services are involved and is not guaranteed. As the requirements may change, the latest specific IA/RMF requirements should be obtained from the requiring site, the Service IA/RMF POC or from the DLA Contracting Officer prior to quoting. Failure to agree to Cybersecurity or Service IA/RMF requirements may result in rejection of the vendor's offer. Failing to disclose that a system cannot meet IA/RMF requirements, failure to meet certification timeframes or failure to receive ATO may result in termination for default under clause 52.249-8 “Default (Fixed- Price Supply and Service).".
The following references are applicable DoD Cybersecurity Regulations and Policies:
(1.) United States Statutes (i.) The Health Insurance Portability and Accountability Act of 1996 (HIPAA) (ii.) The Federal Information Security Management Act (FISMA) (iii.) The E-Government Act of 2002
(2.) Office of Management and Budget (OMB) (i.) Circular A-130 (ii.) Guidance M-05-24, Implementation of Homeland Security Presidential Directive (HSPD) 12-Policy for a Common Identification Standard for Federal Employees and Contractors
(3.) National Institute of Standards and Technology (NIST) (i.) The following publications are located at http://www.nist.gov/publication-portal.cfm (ii.) NIST Special Publication (SP) 800-37 - Guide for Applying the Risk Management Framework (RMF) to Federal Information Systems (iii.) NIST SP 800-53 - Security and Privacy Controls for Federal Information Systems and Organizations
(4.) Federal Information Processing Standards (FIPS)
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SECTION B - SUPPLIES OR SERVICES AND PRICES OR COSTS (CONTINUED)
(i.) The following publications are located at http://www.nist.gov/itl/fipscurrent.cfm (ii.) FIPS Publication (FIPS PUB) 140-2, Security Requirements for Cryptographic Modules (iii.) FIPS PUB 199 - Standards for Security Categorization of Federal Information and Information Systems (iv.) FIPS PUB 201-2, Personal Identity Verification of Federal Employees and contractors
(5.) Department of Defense (DoD) (i.) The following publications are located at http://www.dtic.mil/whs/directives/ (ii.) DoD Instruction 5200.2, DoD Personnel Security Program (PSP) (iii.) DoD Instruction 8500.1, Cybersecurity (iv.) DoD Instruction 8520.02, Public Key Infrastructure (PKI) and Public Key (PK) Enabling (v.) DoD Instruction 8510.01, Risk Management Framework Process (RMF) (vi.) DoD Instruction 8551.1, Ports, Protocols, and Services Management (PPSM) (vii.) DoD Instruction 8580.02, Security of Individually Identifiable Health Information in DoD Health Care Programs (viii.) DoD Instruction 6025.18, Privacy of Individually Identifiable Health Information in DoD Health Care Programs (ix.) DoD Directive 5400.11, DoD Privacy Program (x.) DoD Manual 5400.11-R, Department of Defense Privacy Program
VII. ELECTRONIC CATALOG SYSTEM (ECAT)
(a.) Description of ECAT: DLA Troop Support operates and manages the DLA Electronic Catalog System (ECAT).
All catalog updates, changes, or deletions will be processed by the DLA Troop Support Contracting Officer. DLA Troop Support's Medical Supply Chain developed ECAT to streamline its business practices and expand its range of procurement options. ECAT is a Net-centric ordering, distribution, and payment system providing Department of Defense and other Federal customers access to multiple manufacturer and distributor commercial catalogs at discounted prices along with specialty noncommercial items as envisioned under this program. ECAT automates the entire customer procurement cycle - from searching for products, to creating reorder lists, to submitting an order, to approving an order, to receiving and paying for an order. The MediPrice loader catalog is the prescribed format for entering vendors contract items on ECAT.
(b.) Terms and Conditions Applicable to ECAT:
(1.) The contractor agrees to use the ECAT system to display its catalog for items available to all authorized users.
(2.) The contractor agrees to let all DLA customers authorized to enter the ECAT system to view any information displayed in the system.
(3.) DLA Troop Support may place manual orders under any contract awarded against this solicitation.
(4.) Two contract numbers will be assigned to each contract award. One Administrative contract for automated orders through ECAT and the basic contract number for manual orders placed by DLA Troop Support contract specialists.
(5.) The contractor shall provide its own computer hardware and software necessary to transmit and receive electronic orders.
(6.) All items will be identified by the manufacturer's name and part numbers and conform to the manufacturer's
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SECTION B - SUPPLIES OR SERVICES AND PRICES OR COSTS (CONTINUED)
specifications.
(7.) All terms and conditions, including the contract maximum, of the vendor's basic contract, shall remain in full force and effect for any orders issued through ECAT and manual orders.
(8.) Individual ECAT delivery orders cannot be modified besides just being cancelled if approved by the Contracting Officer within five calendar days of order issuance. Vendors shall accept all orders issued through ECAT, and vendors are not authorized to reject (kill) any order without written preapproval of DLA.
(9.) In order to add/change items in ECAT, the items must first be added/changed under the basic contract. If any basic contract item changes, including items making up an ECAT administrative configuration (defined in Section 14.
ii. below), the vendor shall immediately notify the Contracting Officer and shall not accept any orders for the item or ECAT administrative configuration until it matches the basic contract.
(10.) The following items shall not be offered under an ECAT administrative contract even if they are on the basic contract:
(i.) Any item, installation or service that is not pre-priced on the MediPrice loader catalog.
(ii.) Any incidental service that is not pre-priced on the MediPrice loader catalog.
(iii.) Non-TAA items currently on the MediPrice loader catalog under the Systems Components category as defined in TAA Compliance Section.
(iv.) Zero dollar items.
(11.) For all DoD customers, the vendor shall only offer and accept system requirements under their ECAT administrative contract where they agree to offer systems that meet DoD Cybersecurity and individual Military Service Risk Management Framework (RMF) requirements, along with having a supported operating system. By accepting any DoD requirement in ECAT, the vendor confirms that they have a valid RMF Authorization to Operate (ATO) or agrees to go through the RMF approval process and obtain an ATO. Additionally, vendors are required to complete and provide a completed service specific RMF Cybersecurity Questionnaire template upon request by the customer. A vendor performing on a DoD Customer order issued through ECAT constitutes agreement to comply with the applicable Services' RMF requirements.
Vendors may offer systems that do not meet DoD Cybersecurity RMF requirements under an administrative ECAT contract solely for purchase by non-DoD customers, such as the Veterans Administration. This must be noted on the vendor's MediPrice loader catalog by adding “NOT COMPLIANT WITH RMF” in the BEGINNING of the item's Product Description.
(12.) When applicable for a specific medical equipment item, the vendor shall only offer and accept system requirements under their ECAT administrative contract where they agree to offer systems that are able to interface with MHS GENESIS/Cerner Millennium Electronic Health Record (EHR). A vendor performing on a DoD Customer order issued through ECAT constitutes agreement to provide a system that shall interface with MHS Genesis/Cerner Millennium EHR. Applicability shall be determined prior to adding the item to ECAT.
(13.) Each individual item, defined as each item on the MediPrice loader catalog that has its own part number or administrative configuration part number and price, on an ECAT administrative contract shall be considered an end product; thus, it must be in compliance with the Trade Agreement Act (TAA).
(14.) The vendor must follow one of the following strategies for offering systems through ECAT:
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(i.) The entire system can be bought through a single part number.
(ii.)Vendors may offer ECAT administrative configuration part numbers for ease of ordering by customers for full systems where there is no single part number configuration offered and the end product system is built from multiple part numbers.
(A.) Each ECAT administrative configuration part number shall be comprised of existing part numbers that are already on the vendor's basic contract.
(B.) The total price of the ECAT administrative configuration part number must be at or below the combined price of all individual contract part numbers that make up the administrative configuration.
(C.) If any part number's pricing goes down on the basic contract, than the ECAT configuration price must be reduced accordingly.
(D.) ECAT administrative configuration part numbers may only be used for ordering through the administrative ECAT contract and cannot be used for regular orders through the basic contract.
(E.) ECAT administrative configuration part number additions and changes must occur via submission of an ECAT Administrative Configuration Form, supplemental to the MediPrice loader catalog spreadsheet, matching the item(s) in the basic contract. The MediPrice loader catalog and ECAT Administrative Configuration Form will be provided by the Contracting Officer to any contract holder considering to establish an administrative ECAT contract. Items or their pricing may not be changed without formal review, approval and upload to ECAT by DLA.
(iii.) The entire system can be bought by combination of a base system part number and additional customization part numbers already on the basic contract. The base system would be a partial configuration that all customers would receive and would be a single part number or single administrative configuration part number. Further customization to achieve a fully operational system would occur by adding a limited number of accessory or component part numbers on top of the base system. If utilizing this approach, the vendor must ensure that a customer can order a full system by selecting no more than 10 part numbers in ECAT. This method may result in multiple orders being issued that together would make up a single system. This could be caused by customer error or system issues, but the vendor would be obligated to accept all orders if using this method.
(c.) Electronic Catalog System (ECAT) Technical Requirements
(1.) The Contractor shall submit and maintain an Electronic Price and Product Catalog(s) listing all items available to the customers ordering under this contract. The submission of the data shall be by the MediPrice loader catalog template format.
(2.) For the most current guidelines to submit MediPrice additions, changes or deletions, refer to https://www.
medical.dla.mil/Portal/ under the ECAT tab, and look for instructions on the left side of the screen under the subheading "Info For Suppliers." Any future updates to the ECAT catalog requirements will be listed on the website.
(3.) Electronic System Requirements
(i.) ECAT offers a browser-based supplier interface to allow contractors to respond to orders. ECAT employs the Web Supplier Interface [Supplier Order Management (SOM)] to facilitate electronic commerce (EC). The vendor must utilize Supplier Order Management. The Supplier Order Management guide is located at https://www.medical.
dla.mil/Portal/ECAT/EcatHome.aspx under the ECAT tab (subheading “Info for Suppliers”). EDI interface is not allowed under any resultant contract.
(ii.) The contractor shall use the Supplier Order Management link within ECAT to acknowledge the order(s), provide a shipping date, shipping company, and tracking number within the ECAT software, which in turn will update the
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customer's status.
(iii.) Profile information will be required for the individual/group receiving the e-mail notification of new orders. This will include, but is not limited to name, phone number, fax number, and e-mail address.
(iv.) The contractor shall provide its own computer hardware and software necessary to use Supplier Order Management. The contractor must have an Internet connection and a Web browser (Internet Explorer 10.0 or better is recommended).
VIII. TRADE AGREEMENT ACT (TAA) COMPLIANCE:
(a.) All orders shall comply with DFARS 252.225-7021 Trade Agreements.
(b.) Vendors may add to the contract any items categorized as “System Components” where they use a part number/ price structure that lists separately components that make up the end product. System Components allow addition of components to the contract that do not independently meet the requirements of the Trade Agreements Act (TAA), but are components of a higher level end product that is fully compliant with DFARS 252.225-7021 Trade Agreements.
All the following conditions must be met by a System Component in order to be allowable under the contract and to comply with TAA regulations:
(1.) The item must be a component of a higher level end product that is TAA clause compliant and shall be essential to proper functioning of the higher level end product.
(2.) The System Components shall never be purchased individually and can only be ordered as part of the higher level end product that is fully TAA clause compliant. System Components cannot be put on the ECAT.
(3.) The items shall be identified in the MediPrice loader catalog by placing “COMPONENT” in the country of origin column followed by the country code.
(4.) The vendor shall provide all information typically provided for product addition requests for regular end products; including price, country of origin, product description, etc.; along with additional information specifying the system(s) that they are part of.
(5.) The price of a System Component or combination of System Components that are manufactured in non-TAA countries shall never constitute a majority of an end product system price or delivery order price.
(6.) The vendor certifies that all end products that are delivered to the Government under this contract are in full compliance with DFARS 252.225-7021 Trade Agreements.
SECTION D - PACKAGING AND MARKING
(a.) Preservation, packaging, and packing shall be sufficient to preclude damage to containers and/or contents thereof under normal shipping and handling conditions. Exterior (shipping) containers shall conform to the applicable carrier's regulations and shall be substantial commercial containers of the type, size and kind commonly used for the purpose, so constructed as to insure acceptance and safe delivery by common or other carriers, at the lowest rate, to point of delivery called for in the delivery order. Shipments to OCONUS ordering activities shall be properly packaged and packed for international movement.
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(b.) Materiel shall be marked in accordance with commercial practice, any applicable regulatory requirements, and as stated in the delivery order.
(c.) For all items requiring special handling (i.e. hazardous, perishable, and sensitive material) labeling and marking shall be in accordance with applicable regulatory requirements and as specified in the delivery order.
THE FOLLOWING CLAUSES ARE INCORPORATED BY REFERENCE
252.211-7003 Item Unique Identification and Valuation (MAR 2016)
252.211-7008 Use of Government-Assigned Serial Numbers (SEP 2010)
SECTION E - Inspection and Acceptance
I. GOVERNMENT INSPECTION, ACCEPTANCE, AND PAYMENT TERMS AND CONDITIONS
(a.) Payment Terms: Prompt Payment terms apply in accordance with 52.232-25 Prompt Payment. Delivery orders issued for equipment/systems not requiring installation shall be issued with 100% of the total price of the equipment/ system being paid after final inspection and acceptance has occurred. Vendors must utilize Wide Area Workflow (https://wawf.eb.mil/) and be registered to use WAWF for inspection, acceptance and payment purposes.
(b.) Final Inspection/Acceptance for Manual Delivery Orders Not Issued through ECAT:
(1.) Final Acceptance Procedures
Upon completion of delivery and after contractor makes available to the using activity any training (e.g. initial applications and operator training) required by the manufacturer to properly use the equipment, the equipment shall be turned over to the facility for clinical use. Concurrently, the contractor shall furnish a written notice of readiness for inspection using the WAWF system and ensure the following Government personnel cited on the delivery order are notified via email:
• DLA Troop Support Biomedical Engineer
• Service POC (if applicable)
• Local site POC
Clinical use will be presumed to begin on the day after the notice of readiness for inspection is received by the Government. The using activity must notify the Contracting Officer, contractor, Service Logistics Agency (on applicable DoD orders), and the DLA Troop Support Biomedical Engineer if clinical use is not initiated at this time.
Submission of the notice of readiness for inspection, and any other notice required by this provision by electronic mail is acceptable, provided that the party giving such notice obtains and preserves electronic evidence of receipt at the email address or addresses of the party or parties who have a right to notice under this clause. The Government shall provide appropriate email addresses on the delivery order.
https://wawf.eb.mil/
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(2.) Inspection and Testing
The Government shall have the right to inspect and test the equipment within 30 calendar days after receipt of the notice of readiness for inspection (the 30-day period) or thereafter during the warranty period if the Government fails to inspect and test during this “30-day period.” The contractor shall provide the necessary technical and applications personnel to perform the inspection (and any re-inspections), if necessary. The Government shall provide notice of acceptance of the equipment or of unsatisfactory inspection/test results to the contractor within 10 calendar days after the date of inspection. The latter notice shall identify to the contractor any deficiencies found during the inspection and whether the deficiencies were significant or not, and will provide the contractor 14 calendar days to correct such deficiencies. Contractors shall correct reported deficiencies at no additional cost to the Government and notify the Contracting Officer when all corrections have been made and the equipment is ready for re-inspection. Re-inspection
(s) will be performed by the Government with all costs incurred being at the contractor's expense.
(3.) Warranty Effective Date
Any applicable warranty period will commence on the date the notice of readiness for inspection was submitted (unless the equipment is inspected during the 30-day period and one or more significant deficiencies are found and the system is taken out of clinical use). For systems failing the initial acceptance inspection and then accepted after a Government re-inspection(s), the warranty period will commence on the date the notice of readiness for the successful re-inspection was submitted. If the Government determines only minor (i.e., non-significant) deficiencies are found during inspection and clinical use continues, the warranty date will commence on the date the notice of readiness for inspection was submitted.
(4.) Clinical Use
Clinical use means the delivered equipment as determined by the Government performs the basic intended clinical function of the system in a safe manner for the purpose for which it was designed, with most or all system functionality, allowing the equipment to be used clinically. Clinical use does not include initial patient examinations or procedures during applications training.
If the equipment is put into clinical use by the Government for 30 calendar days after the inspection request, acceptance will occur thereafter as described below. However, if significant deficiencies in the equipment are identified during the 30-day period while it is in clinical use and clinical use ceases, the procedures under “No Clinical Use” will be followed. Clinical use is incompatible with and cannot continue in the event significant deficiencies are identified.
For systems in clinical use for 30 calendar days without significant deficiencies being identified during inspection (if inspection occurs), the contractor will notify the Government that the system has been in clinical use for this time period, and request acceptance and payment. The Government will confirm with the customer whether or not clinical use has occurred for 30 calendar days and, upon positive confirmation, the Government will issue a notice of acceptance and authorize payment (WAWF) within 30 calendar days after receiving the request. In the event that the Government is notified by the customer that clinical use has not occurred for 30 calendar days, the Government shall so notify the contractor within 10 calendar days after receiving the request for acceptance and payment. Within this notice, the Government will provide rationale for why the equipment was not used.
The failure of the Government to notify the contractor of its intent to dispute clinical use within 10 calendar days after receiving the request for acceptance and payment shall constitute acceptance on the part of the Government.
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Acceptance under this paragraph shall not preclude the Government from exercising its rights later under any remedy available to the Government by federal law or regulation. In the event the Government has not conducted an inspection of the equipment within 30 calendar days of the date of the notice of readiness for inspection, during the period of clinical use, the Government shall have the right to inspect the equipment during the warranty period.
Deficiencies discovered during the inspection shall be presented to the contractor for correction as appropriate under the terms of the warranty.
(5.) No Clinical Use
No clinical use means that delivered equipment does not perform the basic intended clinical function in a safe manner for the purpose for which it was designed or that most or all system functionality is not present, preventing the equipment from being used clinically during the 30-day period. If the equipment does not meet the criteria for clinical use, as defined in paragraph 4 above, the system will not be accepted without formal testing under paragraph 2, and final payment will not be issued until after the equipment satisfactorily passes inspection and acceptance as stated above.
(6.) Final Acceptance/Rejection Procedures
In the event the equipment is not placed in clinical use for 30 days, or is so placed and inspected and significant deficiencies are found, within 75 calendar days after receipt of the notice of readiness for inspection, the Government shall:
(i.) accept the equipment; or (ii.) accept the equipment and request that identified defects be remedied under the contract's warranty provisions; or (iii.) request the contractor propose an equitable offset in lieu of correcting defects or rejection; or (iv.) reject and request removal of the equipment.
This section is not intended to affect the parties' rights and responsibilities provided in paragraphs 1 through 5 and paragraph 7 of the Acceptance Procedures.
When requested, the contractor shall propose…
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