S02 RFQ - 36C24120Q0167 - POC Coagulation .docx
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- 36C24120Q0167
- Issued by
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Department of Veterans Affairs
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36C24120Q0167
PAGE 1 OF
1. REQUISITION NO.
2. CONTRACT NO.
3. AWARD/EFFECTIVE DATE
4. ORDER NO.
5. SOLICITATION NUMBER
6. SOLICITATION ISSUE DATE
a. NAME
b. TELEPHONE NO. (No Collect Calls)
8. OFFER DUE DATE/LOCAL
TIME
9. ISSUED BY
CODE
10. THIS ACQUISITION IS
UNRESTRICTED OR
SET ASIDE:
% FOR:
SMALL BUSINESS
HUBZONE SMALL
BUSINESS
SERVICE-DISABLED
VETERAN-OWNED
SMALL BUSINESS
WOMEN-OWNED SMALL BUSINESS
(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED
SMALL BUSINESS PROGRAM
EDWOSB
8(A)
NAICS:
SIZE STANDARD:
11. DELIVERY FOR FOB DESTINA-
TION UNLESS BLOCK IS
MARKED
SEE SCHEDULE
12. DISCOUNT TERMS
13a. THIS CONTRACT IS A
RATED ORDER UNDER
DPAS (15 CFR 700)
13b. RATING
14. METHOD OF SOLICITATION
RFQ
IFB
RFP
15. DELIVER TO
CODE
16. ADMINISTERED BY
CODE
17a. CONTRACTOR/OFFEROR
CODE
FACILITY CODE
18a. PAYMENT WILL BE MADE BY
CODE
TELEPHONE NO.
DUNS:
DUNS+4:
PHONE:
FAX:
17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED
SEE ADDENDUM
19.
20.
21.
22.
23.
24.
ITEM NO.
SCHEDULE OF SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
(Use Reverse and/or Attach Additional Sheets as Necessary)
25. ACCOUNTING AND APPROPRIATION DATA
26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA
ARE
ARE NOT ATTACHED.
27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA
ARE
ARE NOT ATTACHED
28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________
29. AWARD OF CONTRACT: REF. ___________________________________ OFFER
COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND
DATED ________________________________. YOUR OFFER ON SOLICITATION
DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY
(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE
ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED
SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:
30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED
AUTHORIZED FOR LOCAL REPRODUCTION
(REV. 2/2012)
PREVIOUS EDITION IS NOT USABLE
Prescribed by GSA - FAR (48 CFR) 53.212
7. FOR SOLICITATION
INFORMATION CALL:
STANDARD FORM 1449
OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30
SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS
36C24120Q0167 02-07-2020 Julie Lemire 603-629-3293 02-21-2020 2pm Department of Veterans Affairs VAMC Manchester 718 Smyth Road Manchester NH 03104 X 334516 1000 Employees N/A X Department of Veterans Affairs
* see below for all facilities
Dept. of Veterans Affairs Manchester VAMC 718 Smyth Road Manchester NH 03104-7007
Department of Veterans Affairs Financial Services Center per VAAR 852.232-72 Electronic Submission of Payment Request http://www.fsc.va.gov/einvoice.asp See CONTINUATION Page This solicitation is a RFQ for POC COAG units & service. The VA intends to award a firm fixed price BPA. Contractor shall provide all necessary personnel, supervision, labor, equip-ment, materials and disposal necessary to provide items & services at VISN1 Labs pursuant to the SOW described herein.
Quoters should carefully follow instruction included in FAR 52.212-1 & for evaluation criteria specified in FAR 52.212-2 . Pricing should be identified in B.2 Price/Cost Schedule attached to the RFQ.
All quotes shall be emailed to Julie.Lemire@va.gov Any quote that is not compliant with RFQ requirements will not be considered.
A National Business Associate Agreement (BAA) is required.
See CONTINUATION Page x X x Julie Lemire Table of Contents
| SECTION A | 1 |
| A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS | 1 |
| SECTION B - CONTINUATION OF SF 1449 BLOCKS | 4 |
| B.1 CONTRACT ADMINISTRATION DATA | 4 |
| Statement of Work | 6 |
| B.2 PRICE/COST SCHEDULE | 14 |
| ITEM INFORMATION | 14 |
| B.3 DELIVERY SCHEDULE | 16 |
| SECTION C - CONTRACT CLAUSES | 17 |
| C.1 BPA TERMS AND CONDITIONS | 17 |
| C.2 INTRODUCTION | 17 |
| C.3 ADMINISTRATIVE DATA | 17 |
| C.4 AUTHORIZED REPRESENTATIVES | 17 |
| C.5 PERIOD OF PERFORMANCE | 18 |
| C.6 AUTHORIZED LIMITS | 18 |
| C.7 OBLIGATION OF FUNDS | 18 |
| C.8 PRICING | 19 |
| C.9 PRICING DATA | 19 |
| C.10 PERFORMANCE | 19 |
| C.11 INVOICES | 20 |
| C.12 OPTION TO EXTEND THE TERM OF THE BPA | 20 |
| C.13 ORDER FORMAT | 20 |
| C.14 GENERAL SUPPLY ORDERS | 20 |
| C.15 FEDERAL HOLIDAYS | 21 |
| C.16 PRECEDENCE | 21 |
| C.17 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018) | 21 |
| C.18 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018) | 26 |
| C.19 VAAR 852.211-70 EQUIPMENT OPERATION AND MAINTENANCE MANUALS (NOV 2018) | 26 |
| C.20 VAAR 852.211-72 TECHNICAL INDUSTRY STANDARDS (NOV 2018) | 27 |
| C.21 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-OWNED SMALL BUSINESS EVALUATION FACTORS (OCT 2019) | 27 |
| C.22 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (OCT 2019) | 27 |
| C.23 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND COMPLIANCE (JUL 2018) | 28 |
| C.24 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018) | 28 |
| C.25 VAAR 852.246-71 REJECTED GOODS (OCT 2018) | 29 |
| C.26 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018) | 29 |
| C.27 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018) | 30 |
| C.28 VAAR 852.270-1 REPRESENTATIVES OF CONTRACTING OFFICERS (JAN 2008) | 30 |
| C.29 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998) | 30 |
| C.30 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (OCT 2019) | 30 |
| SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS | 38 |
| BUSINESS ASSOCIATE AGREEMENT BETWEEN THE DEPARTMENT OF VETERANS AFFAIRS VETERANS HEALTH ADMINISTRATION, VISN1 Laboratory, AND | 39 |
| SECTION E - SOLICITATION PROVISIONS | 44 |
| E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (OCT 2018) | 44 |
| E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (DEC 2019) | 47 |
| E.3 52.216-1 TYPE OF CONTRACT (APR 1984) | 48 |
| E.4 52.233-2 SERVICE OF PROTEST (SEP 2006) | 49 |
| E.5 VAAR 852.215-72 NOTICE OF INTENT TO RE-SOLICIT (OCT 2019) | 49 |
| E.6 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION (OCT 2018) | 49 |
| E.7 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018) | 50 |
| E.8 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998) | 50 |
| E.9 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014) | 51 |
| E.10 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL ITEMS (DEC 2019) | 52 |
SECTION B - CONTINUATION OF SF 1449 BLOCKS
NO TEXT
B.1 CONTRACT ADMINISTRATION DATA
1. Contract Administration: All contract administration matters will be handled by the following individuals:
| a. CONTRACTOR: | To be determined |
| To be determined |
b. GOVERNMENT: Contracting Officer 36C241 Julie Lemire Department of Veterans Affairs VAMC Manchester
718 Smyth Road Manchester NH 03104
2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:
| [X] |
| 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or |
| [] |
| 52.232-36, Payment by Third Party |
3. INVOICES: Invoices shall be submitted in arrears:
| a. Quarterly | [] |
| b. Semi-Annually | [] |
| c. Other | [x] monthly or up receipt of orders |
4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.
Department of Veterans Affairs Financial Services Center per VAAR 852.232-72 Electronic Submission of Payment Request http://www.fsc.va.gov/einvoice.asp ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:
| AMENDMENT NO |
| DATE |
36C24120Q0167
Page 1 of Page 1 of
STATEMENT OF WORK
Point of Care Coagulation Analyzers VISN 1
Requirement: FDA approved, CLIA Waived Point of Care Coagulation PT/INR testing system for Professional use at the VA Medical Center, CBOC sites and Home-based settings.
The contractor shall provide FDA approved PT/INR test cartridges, meters, quality control and linearity materials, and any ancillary Items required for testing patients in a hospital or outpatient clinic and home-based setting. Vendor to also include any and all middleware/licenses and hardware needed to connect to RALS.
The following are required Point of Care Coagulation Testing and Software Specifications:
· High degree of accuracy and precision of PT/INR value readings
· ISI value close to 1.0 but does not exceed 1.3 with lot to lot variations of no more than 0.2 for ISI of 1.0-1.3.
· Test system insensitive to Heparin therapy
· Supported initial training and implementation (validation studies, etc.)
· Interfaces with VISTA for reporting into patient records
· Supports HL7 interface platform
· Large hematocrit reading range
· Invalid operator lockout
· Lockout for lack of valid control each 24 hours
· Automatic lockout for QC failure
· On board Quality Control- integrated with each analysis
· Methodology with few known interfering substances
· Maintenance-free mechanics
· Unlimited no questions asked replacement policy for rechargeable batteries, meters, base units, downloaders, cradles, carrying cases, and manufacturers manuals, to include
· Overnight shipment when possible
· Replacement with new rather than refurbished meters
· System must have ease of cleaning/disinfecting between patients
· Live Customer Support 24 hours a day, 7 days a week (not answering service)
· Vendor response must specify leakage currents and ground resistance limits
· Reliable with minimum Product Alerts and Recalls
· Rechargeable batteries
The following are desired:
· Quality Control reported as Pass/Fail or numeric option
· Have wireless cable download for hospital meters (desirable)
· Rechargeable Batteries (required)
· Potential for other instrument connectivity to software or ability to manually enter other point of care tests (test such as occult bloods and urinalysis)
· Testing doesn’t begin until test strip is properly filled
· Small sample volume
· Fast readout of test results
· Reads bar-coded operator ID and patient ID wristband and cards
· Sequestering of reagent strips for all sites or for each main campus. This will make sure each main campus and its CBOCS are on the same lot.
PRICING:
Proposals shall include pricing for the following (Cost Per Test/Cost Per Reportable Result):
1. Coagulation Meters and Printers
2. PT/INR Test Strips/Cartridges
3. Linearity Kits
4. Quality Controls
5. Connectivity to include lantronix boxes (if needed), network downloaders (all equipment needed to transmit results from coagulation meter to VISTA
6. Lancets
7. Service to include Live Customer Support 24 hours a day, 7 days a week
8. Manuals
9. Rechargeable Power Packs/ Batteries
10. Installation and Training
Proposals shall include Value Added Incentives.
The estimated total patient test workload for a 12-month period is 12,168 tests. Please see attachment A. This is an estimate only and not a guaranteed total based on prior years workload and anticipated workload from new sites.
ALL OF THE FOLLOWING FACILITIES AND THEIR CBOC’S MAY PARTICIPATE IN THIS SOLICITATION.
Page 1 of Page 1 of
VA Boston Healthcare System
1400 VFW PKWY
West Roxbury, MA 02132
VA Bedford Healthcare System 200 Springs Road Bedford, MA 01730
VA Central Western Mass.
421 North Main St., Leeds, MA 01053
VA Maine Healthcare Center 1 VA Center Augusta, ME 04330
VA White River Junction 215 North Main St.
White River Junction, VT 05001
VA Manchester 781 Smyth Road Manchester, NH 03104
VA Providence 830 Chalkstone, Ave.
Providence, RI 02908
VA West Haven 950 Campbell St.
West Haven, CT 06156
Page 1 of
Please see Attachment A for the using sites and their test volume
Data Source: Workload Statistics, and anticipated workload for new sites.
The Government reserves the right to add more meters and sites from VISN 1 during the terms of this agreement.
1. Contractor will provide a plan for the phase-in of equipment placement at all sites within 60 calendar days of the award date of the contract. It is understood that due to the large number of sites involved, unusual circumstances may prevent 100% installation within 60 calendar days. Contractor must include a contingency plan to address the need to exceed the 60-calendar day phase-in period. The implementation plan will be submitted with the Contractor’s technical proposal for this agreement.
2. The Contractor will notify, within 24 hours, all participating locations and the NCL Program Manager of any recalled reagents or equipment components. This must be accomplished by telephone and/or certified mail. The vendor will provide sufficient replacement items to resolve the problem so no break in services is experienced. Contractor will support use of alternate reagents if required due to recall or multiple performance issues.
3. In the case of a company merger and/or acquisition, the contractor will immediately notify the Contracting officer for this BPA and provide a contingency plan of services to assure that no break in services is experienced by the participating facilities.
4. Vendor is encouraged to offer a spectrum of value-added incentives. Such incentives may include customer and professional service programs (i.e. PACE approved continuing education programs for clinical laboratory staff and new innovations to assist the VA facilities with the usage of the contractor’s products/services in the most cost-efficient manner.
5. The contractor will provide a directory with the names and telephone number(s) of all contact persons to be used by the participating facilities to inquire about billing issues, reagent shipments, service concerns, etc.
6. The equipment will be delivered, ready for interface with the Veterans Health Information Systems and Technology Architecture (VISTA) and the computerized Records Patient System (CPRS). The contractor will provide the hardware, software, and ancillary items including but not limited to port licenses, lantronix boxes, and cables needed to accomplish the interface.
7. Vendor must have Business Associate Agreement (BAA) on file with the VA. There is a requirement in HIPAA to establish BAAs with those business partners with whom VA is associated and who have access to patient information.
8. Vendor must not remove any piece of equipment or component that contains patient information until it is sanitized of patient information. VA will maintain control of the damaged hard drives and dispose of them in accordance with VA policy.
Security Clauses:
1. GENERAL
Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.
2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS
a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.
b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.
c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.
d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.
e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.
3. VA INFORMATION CUSTODIAL LANGUAGE
a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).
b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.
c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.
d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.
e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.
f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.
g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.
h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.
i. The contractor/subcontractor’s firewall and Web services security controls, if applicable, shall meet or exceed VA’s minimum requirements. VA Configuration Guidelines are available upon request.
j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.
k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.
l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COR.
5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE
a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerability scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor’s security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA’s network involving VA information must be reviewed and approved by VA prior to implementation.
b. Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII.
h. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are:
(1) Vendor must accept the system without the drive;
(2) VA’s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or
(3) VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.
(4) Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;
(a) The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and
(b) Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or contract.
(c) A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation.
6. SECURITY INCIDENT INVESTIGATION
a. The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.
b. To the extent known by the contractor/subcontractor, the contractor/subcontractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.
c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.
d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.
7. LIQUIDATED DAMAGES FOR DATA BREACH
a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.
b. The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.
c. Each risk analysis shall address all relevant information concerning the data breach, including the following:
(1) Nature of the event (loss, theft, unauthorized access);
(2) Description of the event, including:
(a) date of occurrence;
(b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;
(3) Number of individuals affected or potentially affected;
(4) Names of individuals or groups affected or potentially affected;
(5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text;
(6) Amount of time the data has been out of VA control;
(7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);
(8) Known misuses of data containing sensitive personal information, if any;
(9) Assessment of the potential harm to the affected individuals;
(10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and
(11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.
d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $40.00 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:
(1) Notification;
(2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;
(3) Data breach analysis;
(4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;
(5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and
(6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.
8. SECURITY CONTROLS COMPLIANCE TESTING
On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-days’ notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time.
9 TRAINING
a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:
(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems;
(2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;
(3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and
(4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]
b. The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.
c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.
B.2 PRICE/COST SCHEDULE
ITEM INFORMATION
| ITEM NUMBER |
| DESCRIPTION OF SUPPLIES/SERVICES |
| QUANTITY |
| UNIT |
| UNIT PRICE |
| AMOUNT |
| 12,168.00 |
| EA |
| __________________ |
| __________________ |
BPA: Year 1: 5/1/2020 - 4/31/2021 Cost Per Test / Cost Per Reportable Result:
| 1. | Coagulation Meters and Printers |
| 2. | PT/INR Test Strips/Cartridges |
| 3. | Linearity Kits |
| 4. | Quality Controls |
| 5. | Connectivity to include lantronix boxes (if needed), network downloaders (all equipment needed to transmit results from coagulation meter to VISTA |
| 6. | Lancets |
| 7. | Service to include Live Customer Support 24 hours a day, 7 days a week |
| 8. | Manuals |
| 9. | Rechargeable Power Packs/ Batteries |
| 10. | Installation and Training |
| 12,168.00 |
| EA |
| __________________ |
| __________________ |
BPA: Year 2: 5/1/2021 - 4/31/2022
| 1. | Coagulation Meters and Printers |
| 2. | PT/INR Test Strips/Cartridges |
| 3. | Linearity Kits |
| 4. | Quality Controls |
| 5. | Connectivity to include lantronix boxes (if needed), network downloaders (all equipment needed to transmit results from coagulation meter to VISTA |
| 6. | Lancets |
| 7. | Service to include Live Customer Support 24 hours a day, 7 days a week |
| 8. | Manuals |
| 9. | Rechargeable Power Packs/ Batteries |
| 10. | Installation and Training |
| 12,168.00 |
| EA |
| __________________ |
| __________________ |
BPA: Year 3: 5/1/2022 - 4/31/2023
| 1. | Coagulation Meters and Printers |
| 2. | PT/INR Test Strips/Cartridges |
| 3. | Linearity Kits |
| 4. | Quality Controls |
| 5. | Connectivity to include lantronix boxes (if needed), network downloaders (all equipment needed to transmit results from coagulation meter to VISTA |
| 6. | Lancets |
| 7. | Service to include Live Customer Support 24 hours a day, 7 days a week |
| 8. | Manuals |
| 9. | Rechargeable Power Packs/ Batteries |
| 10. | Installation and Training |
| 12,168.00 |
| EA |
| __________________ |
| __________________ |
BPA: Year 4: 5/1/2023 - 4/31/2024
| 1. | Coagulation Meters and Printers |
| 2. | PT/INR Test Strips/Cartridges |
| 3. | Linearity Kits |
| 4. | Quality Controls |
| 5. | Connectivity to include lantronix boxes (if needed), network downloaders (all equipment needed to transmit results from coagulation meter to VISTA |
| 6. | Lancets |
| 7. | Service to include Live Customer Support 24 hours a day, 7 days a week |
| 8. | Manuals |
| 9. | Rechargeable Power Packs/ Batteries |
| 10. | Installation and Training |
| 12,168.00 |
| EA |
| __________________ |
| __________________ |
BPA: Year 5: 5/1/2024 - 4/31/2025
| 1. | Coagulation Meters and Printers |
| 2. | PT/INR Test Strips/Cartridges |
| 3. | Linearity Kits |
| 4. | Quality Controls |
| 5. | Connectivity to include lantronix boxes (if needed), network downloaders (all equipment needed to transmit results from coagulation meter to VISTA |
| 6. | Lancets |
| 7. | Service to include Live Customer Support 24 hours a day, 7 days a week |
| 8. | Manuals |
| 9. | Rechargeable Power Packs/ Batteries |
| 10. | Installation and Training |
| GRAND TOTAL |
| __________________ |
B.3 DELIVERY SCHEDULE
VA Boston Healthcare System
1400 VFW PKWY
West Roxbury, MA 02132
VA Bedford Healthcare System 200 Springs Road Bedford, MA 01730
VA Central Western Mass.
421 North Main St., Leeds, MA 01053
VA Maine Healthcare Center 1 VA Center Augusta, ME 04330
VA White River Junction 215 North Main St.
White River Junction, VT 05001
VA Manchester 781 Smyth Road Manchester, NH 03104
VA Providence 830 Chalkstone, Ave.
Providence, RI 02908
VA West Haven 950 Campbell St.
West Haven, CT 061
SECTION C - CONTRACT CLAUSES
C.1 BPA TERMS AND CONDITIONS
This order is subject to the terms referenced in BPA .
C.2 INTRODUCTION
In the spirit of the Federal Acquisition Streamlining Act, the Department of Veterans Affairs (DVA) and hereby enter into a cooperative agreement, otherwise referred to as a Blanket Purchase Agreement (BPA), to further reduce the administrative costs of acquiring supplies/services.
The agreement details all with accompanying prices and descriptions, which may be ordered under this BPA.
All orders placed against this BPA are subject to the terms and conditions of all the clauses and provisions in full text or incorporated by reference in this document.
C.3 ADMINISTRATIVE DATA
A Blanket Purchase Agreement (BPA) is hereby established between and the Department of Veterans Affairs under the following terms and conditions incorporated in this BPA:
Primary Point of Contact: To be determined
Alternate Point of Contact: To be determined
DUNS NUMBER:
Cognizant Office (Include complete address):
Department of Veterans Affairs VAMC Manchester 718 Smyth Road Manchester NH 03104
C.4 AUTHORIZED REPRESENTATIVES
The primary Contracting Officer (CO) for this Agreement is:
| Julie Lemire |
| Contracting Officer |
| Dept. of Veterans Affairs |
| Manchester VAMC |
| 718 Smyth Road |
| Manchester, NH 03104-7007 |
| 603-629-3293 |
| n/a |
| Julie.Lemire@va.gov |
The Primary Contracting Officer's Representative (COR) for projects under this Agreement is:
n/a The Secondary Contracting Officer's Representative (COR) for projects under this Agreement is:
n/a
The Primary and/or Secondary COR will be responsible for technical monitoring of the contractor's performance and deliveries. The COR and the Contractor's Representative shall work together to ensure that all contractual requirements are being met. The COR will interpret specifications or technical portions of the work. The COR is not authorized to perform, formally or informally, any of the following actions:
(1) Promise, award, agree to award, or execute any contract, contract modification, or notice of intent that changes or may change this contract;
(2) Waive or agree to modification of the delivery schedule;
(3) Make any final decision on any contract matter subject to the Disputes Clause;
(4) Terminate, for any reason, the contractor's right to proceed;
(5) Obligate in any way, the payment of money by the Government. Only a warranted Contracting Officer is authorized to obligate funds on this or any other contract action.
The contractor shall immediately notify the Contracting Officer in writing if the COR has taken an action (or fails to take action) or issues directions (written or oral) that the contractor considers to exceed the above limitations.
The contractor shall provide the Contracting Officer information copies of all correspondence to the COR.
C.5 PERIOD OF PERFORMANCE
This BPA expires on 04-30-2025 or such later ending date as determined by the exercise of any option.
C.6 AUTHORIZED LIMITS
The Government estimates, but does not guarantee, that individual BPA Orders placed against this Agreement may reach $78,000.00/per Order. This Order Limit may be increased by mutual agreement of the parties as necessary, in whole or part. The authorized Ceiling Limit of the Agreement is set at $400,000.00 over the period covered by the Agreement; this ceiling is also not a guarantee. The Ceiling Limit may also be raised in association with Order Limit increases or other conditions which, by mutual agreement of the parties, maybe considered necessary. Authorization for individual orders above the stated order and/or Ceiling Limits must be coordinated through the Contracting Officer before larger valued orders can be issued and prior to commencement of work. All unauthorized work, regardless of amount, will be processed through the ratification process.
C.7 OBLIGATION OF FUNDS
This BPA does not obligate any funds. The Government is obligated only to the extent of authorized orders actually issued under the BPA by the Contracting Officer.
C.8 PRICING
Contract as listed below, with associated pricing, can be ordered under this BPA. The Contractor shall be allowed to vary within the categories for successful and efficient task completion not to exceed funded values of each order awarded under this agreement. As proposed, the Contractor will apply applicable extended/tier pricing to all categories used in the performance of orders issued under this Agreement. Orders may be awarded on a Firm-Fixed-Price basis only. All Calls/Orders placed against this BPA are subject to the terms and conditions of the referenced BPA, the Contractor's proposal and this Agreement, except where noted below. Contractor's proposal dated is hereby referenced.
C.9 PRICING DATA
1. The prices included on the BPA list (or applicable "discounted" rates submitted in a proposal response to an RFQ resulting in award) that are in effect on the effective date of an order shall govern that order's basic performance period. With regard to any option years, which are later exercised, the proposed option year rates as incorporated into the order award are in effect until such time, if applicable, that the contractor has been authorized a rate increase culminating from a negotiation with the Contracting Officer.
2. The BPA holder can voluntarily reduce offered prices at any time by giving 24-hour advance notice (by facsimile or electronic-mail) to the Department of Veterans Affairs/Contracting Officer. This BPA also allows for additional discounts if a "large order" is placed at one time. An advanced notice is not required for discounts offered for only an individual order. Whether an order is large enough to warrant such a discount is subject to the discretion of the BPA holder.
3. The BPA holder may also increase BPA prices at any time. Any BPA price increase shall not take effect until the Department of Veterans Affairs Contracting Officer receives written notification (U.S. mail, facsimile, or electronic-mail). Any order already issued shall not be affected by any change to BPA pricing. The prices offered under this BPA will undergo annual review by the Department of Veterans Affairs Contracting Officer.
C.10 PERFORMANCE
The following terms and conditions are applicable:
a. All services will be initiated within 5 calendar days following receipt of a valid order, unless otherwise specified in the order.
b. The BPA holder shall be familiar with Federal Government and Department of Veterans Affairs acquisition regulations, directives and instructions. If a particular document is required in a specific order, it will be cited within the order's PWS.
c. The BPA holder shall not provide technical direction to any other acquisition BPA holder(s) or government personnel at any time. Neither shall the Government directly supervise BPA holder employees. The BPA holder Task Leader should conduct day to day supervision of BPA holder personnel wherever the BPA holder personnel are located. All direction of the BPA holder shall be through the Contracting Officer (CO) of the ordering organization specified in each individual order. Technical "tasking" assignments for the BPA holder will be transmitted by the program office's COR (or program manager) to the BPA holder's Task Leader.
d. The "ordering period" will run from BPA award to 04-30-2025, or until such ending date of any option year, which may be exercised under the Agreement. The "performance period" will terminate with the end of the BPA, unless the ordering CO elects to extend performance as provided under the BPA. If the ordering CO elects to extend performance beyond the end of the BPA, he/she may extend performance up to six (6) months beyond the end of the order period.
e. Capitalization Requirements: The BPA holder shall provide their employees sufficient computer equipment to support orders. The BPA holder shall be able to support the automatic transmission of unclassified data only to the requiring Program Office by modem if so requested. Any computers connected to, or transmits to (connected or via magnetic media) the government shall be properly protected from computer viruses. The BPA holder shall be capable of supporting the software packages utilized by Department of Veterans Affairs for the indicated processors. Specific software packages utilized within a program office shall be stated in the order PWS if it is other than Microsoft Office Professional or Microsoft Project.
f. Cancellation: This BPA may be canceled if the BPA holder fails to perform in accordance with the terms and conditions of this BPA, any order established under this BPA, or if deemed as in the best interests of the Government. The BPA holder must strictly comply with all terms and conditions or the Department of Veterans Affairs/ Contracting Officer may determine that performance by the BPA holder has been unsatisfactory and cancel this BPA.
C.11 INVOICES
a. Inspection and acceptance shall be accomplished as follows: The Government, for all services furnished under any resulting order, hereby designates the COR in the program office as the point of final inspection and acceptance. The BPA holder will submit each invoice, including all back-up data, to the Contracting Officer (CO) for review and signature. When the CO receives an accurate and complete invoice, he/she will return a signed copy to the BPA holder within five (5) working days. If the invoice is incomplete or inaccurate, the CO will return the unsigned invoice to the BPA holder for correction. The Contracting Officer will then forward the signed invoice to the Chief Financial Officer (CFO) for payment. Final payment for each order will be accomplished by final invoice accompanied by a receiving report.
b. An itemized invoice shall be submitted to the CO at least monthly or upon expiration of this BPA, whichever occurs first, for all deliveries made during a billing period and for which payment has not been received. Copies of delivery tickets shall support these invoices. "Approved-for-payment" invoices will be submitted to the payment address specified on each individual order issued under this BPA.
C.12 OPTION TO EXTEND THE TERM OF THE BPA
a. The Government may extend the term of this BPA by written notice to the Contractor at any time prior to the expiration of the BPA, provided that the Government shall give the Contractor a preliminary written notice of its intent to extend at least 15 days before the BPA expires. The preliminary notice does not commit the Government to an extension.
b. If the Government exercises this option, the extended BPA shall be considered to include this option provision.
C.13 ORDER FORMAT
Orders will be placed against this BPA via e-mail, Electronic Data Interchange (EDI), FAX, or in hardcopy format. Each individual BPA Order will describe the tasks, services and deliverables required.
C.14 GENERAL SUPPLY ORDERS
A properly appointed Department of Veterans Affairs Contracting Officer will request a quote from the Contractor based upon the requirements of the individual calls/orders, usually in the form of a Statement of Work (SOW). The information provided to the Contractor will include the place of performance, required period of performance, and other particular task requirements. Travel may be required (reimbursement of travel expenses will be IAW applicable Federal travel regulations). The vendor will reply within 10 business days with a Firm-Fixed-Price quote depending on the details required by the SOW. The Contractor may offer additional spot discounts on any order, as they deem appropriate. All subcontractor activity must be clearly identified in each new order proposal as applicable.
C.15 FEDERAL HOLIDAYS
Unless specifically authorized in writing by the Contracting Officer, no services will be provided and no charges will be incurred and/or billed to any order on this contract on any of the Federal Holidays listed below.
| New Year’s Day |
| Labor Day |
| Birthday of Martin Luther King, Jr. |
| Columbus Day |
| Washington’s Birthday |
| Veterans' Day |
| Memorial Day |
| Thanksgiving Day |
| Independence Day |
| Christmas Day |
C.16 PRECEDENCE
The Terms and conditions included in this BPA apply to all purchases made pursuant to it. In the event of an inconsistency between the provisions of this BPA and the Contractor's invoice, the provisions of this BPA will take precedence.
C.17 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)
(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance.
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