36C25622Q1362.pdf

A.1 COMBINED SYNOPSIS/SOLICITATION NUMBER IS 36C25622Q1362

1. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, in conjunction with FAR Part 13, Simplified Acquisition Procedures for Certain Commercial Items as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. This requirement will be evaluated using the comparative evaluation process outlined in FAR 13.106- 2 (b) (3), where quotations will be compared to one another to determine which provides the best benefit to the Government.

2. The combined synopsis/solicitation number is 36C25622Q1362.

3. Solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2022-07 (eff. 08/10/2022)

4. This requirement is an unrestricted procurement. The North American Industry Classification System number is 334516 with a size standard of 1000 Employees

5. Place of Performance: Southeast Louisiana Veterans Health Care Systems (SLVHCS) Pathology and Laboratory Medicine Service Hematology Laboratory, 2400 Canal Street, New Orleans, LA 70119.

6. Period of Performance: The period of performance shall be a base period of 180 days after receipt of order.

7. All questions regarding this solicitation shall be submitted via email to Contract Support Specialist, Alan Scanio at alan.scanio@va.gov no later than 10:00A.M. Central Time on 09/08/2022.

8. Quotes are due no later than 09/13/2022 at 10:00A.M. Central Time and shall be submitted electronically via e-mail to the Contract Support Specialist, Alan Scanio at alan.scanio@va.gov.

APPLICABLE Provisions and Clauses

The provision at 52.212-1 Introduction to Offerors – Commercial, applies to this acquisition.

The provision at 52.212-2 EVALUATION – COMMERCIAL ITEMS (JAN 1999) applies to this acquisition.

All offers shall include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications –Commercial Items.

The clause at 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition and a statement. The addendum to FAR 52.212-4 also applies to this acquisition.

The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items, applies to this acquisition and all additional FAR clauses cited in the clause are applicable to the acquisition.

Addendum to FAR 52.212-4 Show FAR clauses followed by VAAR clauses in numeric order.

Solicitation contains a list of all clauses incorporated by reference in numeric order under 52.252-2 (see below), starting first with FAR and followed by VAAR.

36C25622Q1362

Table of Contents

A.1 COMBINED SYNOPSIS/SOLICITATION NUMBER IS 36C25622Q1362

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 DELIVERY SCHEDULE

B.4 STATEMENT OF WORK

SECTION C - CONTRACT CLAUSES

C.1 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

C.2 VAAR 852.212-71 GRAY MARKET ITEMS (APR 2020)

C.3 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND

COMPLIANCE (JUL 2018)

C.4 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) ... 27

C.5 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

C.6 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.7 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (NOV 2021)

C.8 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAY 2022) (JUL 2020) (DEVIATION)

C.9 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.2 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.3 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (NOV 2021)

E.4 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.5 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2022) (JUL 2020)

(DEVIATION)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C256 Le Kisha Douglas

Department of Veterans Affairs

Network Contracting Office 16

5075 Westheimer Road, Suite 750

Houston TX 77056-5643

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

[X] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] After Delivery, Installation and Training

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.

FSC e-Invoice Payment http://www.fsc.va.gov/fsc/einvoice.asp

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO DATE

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBE

R

DESCRIPTION OF

SUPPLIES/SERVIC

ES

QUANTIT

Y

UNI

T UNIT PRICE AMOUNT

1.00 EA ________________

FACSLyric 3L10C Instrument US-IVD to include shipping and handling. All line items are brand name or approved equal.

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies

LOCAL STOCK NUMBER: 662878

Computer Bundle Z2 Mini G5 FACSLink PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment

LOCAL STOCK NUMBER: 665070

Computer Bundle Z2MiniG5 FACSLyric USIVD PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment

LOCAL STOCK NUMBER: 665062

Assy Printer HP Color LaserJet Pro PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment

LOCAL STOCK NUMBER: 665425

Monitor Desktop NEC Display 27 Inch LED PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment

LOCAL STOCK NUMBER: 664872

Scanner Barcode GD4400-B 2D PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment

LOCAL STOCK NUMBER: 663058

BD FACSLyric Extended Use Tanks PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment

LOCAL STOCK NUMBER: 651158

FACSLyric Universal Auto Loader USIVD PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment

LOCAL STOCK NUMBER: 662879

Assembly Tube Rack 30 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment

LOCAL STOCK NUMBER: 651314

CST beads 50T IVD PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment

LOCAL STOCK NUMBER: 662413

Custom FC Bead Dilution Buffer PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment

LOCAL STOCK NUMBER: 661614

BD FACS Clean Solution 5L PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment

LOCAL STOCK NUMBER: 340345

BD FACSflow Sheath Fluid 20L PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment

LOCAL STOCK NUMBER: 99-30211-00

Assembly Tube Rack 40 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment

LOCAL STOCK NUMBER: 651319

BD FC Beads 7-Color Kit (US-IVD) PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment

LOCAL STOCK NUMBER: 662961

BD FC Beads BV605 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment

LOCAL STOCK NUMBER: 661626

BD FC Beads APC-R700 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory

Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment

LOCAL STOCK NUMBER: 661625

BD FC Beads APC-H7 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment

LOCAL STOCK NUMBER: 661621

BD FC Beads V500-C PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment

LOCAL STOCK NUMBER: 661624

BD FC Beads V450 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment

LOCAL STOCK NUMBER: 661623

Trucount Absolute Counting Tubes IVD PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment

LOCAL STOCK NUMBER: 340334

IQ/OQ Combo Lyric IVD PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment

LOCAL STOCK NUMBER: 663015

Software Assurity Linc RSS Internet access must be enabled before installation of Assurity Linc software on your BD instrument workstation. The Assurity Linc connection enables BD to collect system health status data and enables customer to initiate Remote Desktop Sharing with BD when needed. By requesting BD Assurity Linc software, you agreed to enable internet access on your computer and that you will allow BD to collect system health data. Customer must ensure that no sensitive data is available on the desktop when Remote Desktop Sharing is initiated.

PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment

LOCAL STOCK NUMBER: 664017

Module FACSuiteMultitest 4c Assay US IVD PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment

LOCAL STOCK NUMBER: 664236

Module FACSuiteMultitest 6c Assay US IVD PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment

LOCAL STOCK NUMBER: 664237

Power Manager Uninterrupted 120V/ 1440VA PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment

LOCAL STOCK NUMBER: 662338

GRAND TOTAL ________________

B.3 DELIVERY SCHEDULE

ITEM NUMBER QUANTITY

DELIVERY

DATE

0001 SHIP TO: Southeast Louisiana Veterans Health Care Systems ( Pathology and Laboratory Medicine Service Hematolo 2400 Canal Street New Orleans, LA 70119

1.00 180 days after receipt of order

0002 SHIP TO: Southeast Louisiana Veterans Health Care Systems ( Pathology and Laboratory Medicine Service Hematolo 2400 Canal Street New Orleans, LA 70119

1.00 180 days after receipt of order

0003 SHIP TO: Southeast Louisiana Veterans Health Care Systems ( Pathology and Laboratory Medicine Service Hematolo 2400 Canal Street New Orleans, LA 70119

1.00 180 days after receipt of order

0004 SHIP TO: Southeast Louisiana Veterans Health Care Systems ( Pathology and Laboratory Medicine Service Hematolo 2400 Canal Street New Orleans, LA 70119

1.00 180 days after receipt of order

0005 SHIP TO: Southeast Louisiana Veterans Health Care Systems ( Pathology and Laboratory Medicine Service Hematolo 2400 Canal Street New Orleans, LA 70119

1.00 180 days after receipt of order

0006 SHIP TO: Southeast Louisiana Veterans Health Care Systems ( Pathology and Laboratory Medicine Service Hematolo 2400 Canal Street New Orleans, LA 70119

1.00 180 days after receipt of order

0007 SHIP TO: Southeast Louisiana Veterans Health Care Systems ( Pathology and Laboratory Medicine Service Hematolo 2400 Canal Street New Orleans, LA 70119

1.00 180 days after receipt of order

0008 SHIP TO: Southeast Louisiana Veterans 1.00 180 days after

Health Care Systems ( Pathology and Laboratory Medicine Service Hematolo 2400 Canal Street New Orleans, LA 70119 receipt of order

0009 SHIP TO: Southeast Louisiana Veterans Health Care Systems ( Pathology and Laboratory Medicine Service Hematolo 2400 Canal Street New Orleans, LA 70119

1.00 180 days after receipt of order

0010 SHIP TO: Southeast Louisiana Veterans Health Care Systems ( Pathology and Laboratory Medicine Service Hematolo 2400 Canal Street New Orleans, LA 70119

1.00 180 days after receipt of order

0011 SHIP TO: Southeast Louisiana Veterans Health Care Systems ( Pathology and Laboratory Medicine Service Hematolo 2400 Canal Street New Orleans, LA 70119

1.00 180 days after receipt of order

0012 SHIP TO: Southeast Louisiana Veterans Health Care Systems ( Pathology and Laboratory Medicine Service Hematolo 2400 Canal Street New Orleans, LA 70119

1.00 180 days after receipt of order

0013 SHIP TO: Southeast Louisiana Veterans Health Care Systems ( Pathology and Laboratory Medicine Service Hematolo 2400 Canal Street New Orleans, LA 70119

1.00 180 days after receipt of order

0014 SHIP TO: Southeast Louisiana Veterans Health Care Systems ( Pathology and Laboratory Medicine Service Hematolo 2400 Canal Street New Orleans, LA 70119

1.00 180 days after receipt of order

0015 SHIP TO: Southeast Louisiana Veterans Health Care Systems ( Pathology and Laboratory Medicine Service Hematolo 2400 Canal Street New Orleans, LA 70119

1.00 180 days after receipt of order

0016 SHIP TO: Southeast Louisiana Veterans Health Care Systems (

1.00 180 days after

Pathology and Laboratory Medicine Service Hematolo 2400 Canal Street New Orleans, LA 70119

0017 SHIP TO: Southeast Louisiana Veterans Health Care Systems ( Pathology and Laboratory Medicine Service Hematolo 2400 Canal Street New Orleans, LA 70119

1.00 180 days after receipt of order

0018 SHIP TO: Southeast Louisiana Veterans Health Care Systems ( Pathology and Laboratory Medicine Service Hematolo 2400 Canal Street New Orleans, LA 70119

1.00 180 days after receipt of order

0019 SHIP TO: Southeast Louisiana Veterans Health Care Systems ( Pathology and Laboratory Medicine Service Hematolo 2400 Canal Street New Orleans, LA 70119

1.00 180 days after receipt of order

0020 SHIP TO: Southeast Louisiana Veterans Health Care Systems ( Pathology and Laboratory Medicine Service Hematolo 2400 Canal Street New Orleans, LA 70119

1.00 180 days after receipt of order

0021 SHIP TO: Southeast Louisiana Veterans Health Care Systems ( Pathology and Laboratory Medicine Service Hematolo 2400 Canal Street New Orleans, LA 70119

1.00 180 days after receipt of order

0022 SHIP TO: Southeast Louisiana Veterans Health Care Systems ( Pathology and Laboratory Medicine Service Hematolo 2400 Canal Street New Orleans, LA 70119

1.00 180 days after receipt of order

0023 SHIP TO: Southeast Louisiana Veterans Health Care Systems ( Pathology and Laboratory Medicine Service Hematolo 2400 Canal Street New Orleans, LA 70119

1.00 180 days after receipt of order

0024 SHIP TO: Southeast Louisiana Veterans Health Care Systems ( Pathology and Laboratory Medicine

Service Hematolo 2400 Canal Street New Orleans, LA 70119

0025 SHIP TO: Southeast Louisiana Veterans Health Care Systems ( Pathology and Laboratory Medicine Service Hematolo 2400 Canal Street New Orleans, LA 70119

1.00 180 days after receipt of order

0026 SHIP TO: Southeast Louisiana Veterans Health Care Systems ( Pathology and Laboratory Medicine Service Hematolo 2400 Canal Street New Orleans, LA 70119

B.4 STATEMENT OF WORK

Statement of Work

Flow Cytometer

Southeast Louisiana Veterans Health Care System

New Orleans, LA

1. PURPOSE

This item is being purchased as a replacement for an end-of-life BD Flow Cytometer located in Pathology & Laboratory Medical Service Line. This instrument aids in the diagnosis and treatment of leukemias and Lymphomas in blood, bone marrow, lymph node, and body fluids. In addition, it is utilized to provide CD4 counts for treatment planning for Aids and HIV-positive patients.

2. SCOPE

2.1 The contractor shall provide, deliver, and install the Flow Cytometer or approved equal with all specified salient characteristics. All equipment provided by the contractor shall be new.

2.2 All equipment and configuration must meet manufacturers and VA specifications.

2.3 The contractor shall furnish all supplies, equipment, facilities, and services required for delivery and configuration of the supplies and equipment.

2.4 The contractor is responsible for all missing parts and components not included in order to carry out the installation and configuration.

2.5 SALIENT CHARACTERISTICS

2.5.1 Flow Cytometer

Manufacturer Brand Name: BD FACSLyric Flow Cytometer or approved equal

• Must be capable of 10-color analysis

• Microsoft with Windows Base Operating System

• FDA approved system and software

• Minimal daily maintenance such that analyzer is not required to be down for more than 60 minutes per day

• Must allow for the highest resolution possible through-out the dynamic range to detect small and subpopulations.

• Minimal compensation frequency (frequency no greater than once per month)

• Must provide high sensitivity and resolution

• Must provide single tube analysis for CD4/TBNK analysis

2.5.2 Data management system with:

Software Assurity Linc RSS or approved equal

• Software for remote data analysis, manipulation, and interpretation by technologists and hematopathologists

• Automatic and manual system compensation

• Real-time compensation, data analysis, and gating

• Fully digital electronics for linear, log, etc. for all collected parameters, with post-acquisition electronics

• The ability to create custom test panels

• A quality control package used for daily monitoring of system performance and operator notification upon QC failure

2.5.3 Training:

• The contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation

• Training shall include in-person training of two staff employees offsite at a remote location. The training shall consist of the operation of the system, data manipulation, and basic troubleshooting and repair.

• The cost of transportation the remote location, hotel accommodations and transfers shall be included.

2.5.4 Printer

• A printer connected to the analyzer for test result reporting

2.5.5 Monitor

• A data display widescreen, flat-panel LCD monitor, 22 in or 24 in diagonal

2.5.7 Installation and validation of equipment

• Vendor must install and verify that instrument, and software is in acceptable working order as determined by the COR.

• Validation studies of the instrument and software by the vendor must be acceptable.

2.5.8 Computer

• Must be loaded with leukemia/lymphoma analyzing software for data analysis, manipulation and interpretation by Pathologist

3.0 Delivery and Installation:

Contractor shall deliver all equipment to the Southeast Louisiana Veterans Health Care Systems (SLVHCS) Pathology and Laboratory Medicine Service Hematology Laboratory, Rm 4E125E, 2400 Canal Street, New Orleans, LA 70119 within 180 days after receipt of order (ARO).

• Deliver materials to job in manufacturer’s original sealed containers with brand name marked thereon.

• Deliver specified items only when the site is ready for installation work to proceed.

• Any government requested delayed delivery up to 90 days after initial award delivery date, shall be at no additional cost to the Government

• Delivery will be coordinated through the COR.

• Installation must be completed by within 30 days of delivery. All work shall be completed between 8:00a.m. – 4:30p.m. Monday- Friday. All federal holidays, excluded.

• The contractor shall coordinate all deliveries with the COR.

4.0 Inspection and Acceptance:

• The contractor shall conduct a joint inspection with the COR upon delivery of equipment.

• The COR will ensure all work is completed satisfactorily prior to acceptance. Disputes will be resolved by the Contracting Officer.

5.0 Deliverables:

• Two Operator Manuals, hardcopy, and two Technical Manuals, hardcopy.

6.0 Site Conditions:

• There shall be no smoking, eating, or drinking inside the hospital at any time.

7.0 Protection of Property

• Contractor shall protect all items from damage. The Contractor shall take precaution against damage to the building(s), grounds and furnishing.

The Contractor shall repair or replace any items related to building(s) or grounds damaged accidentally or on purpose due to actions by the Contractor.

• The Contractor shall perform an inspection of the building(s) and grounds with the COR prior to commencing work. To ensure that the Contractor shall be able to repair or replace any items, components, building(s) or grounds damaged due to negligence and/or actions taken by the Contractor. The source of all repairs beyond simple surface cleaning is the facility construction contractor (or appropriate subcontractor), so that building warranty is maintained. Concurrence from the VA Facilities Management POC and COR is required before the Contractor may perform any significant repair work. In all cases, repairs shall utilize materials of the same quality, size, texture, grade, and color to match adjacent existing work.

• The contractor shall provide floor protection while working in all VA facilities. All material handling equipment shall have rubber wheels.

8.0 Security Requirements

The Certification & accreditation (C&A) are required.

See Attachment 1 for Security requirements

9.0 Warranty

• The contractor shall provide a one-year manufacturer’s warranty on all parts and labor to begin at point of installation.

• The warranty shall include all travel and shipping costs associated with any warranty repair.

• The warranty will be for a period of 1 year which will begin at the point of installation

• The contractor shall provide emergency equipment repair and preventative maintenance

• A technical assistance center must be available by telephone 24 hours per day, 7 days per week with a maximum call back response time of 2 hours.

• Equipment warranty service must be provided during core business hours. Business hours are defined as Monday-Friday, 8:00 am – 4:30 pm.

Certain circumstances may dictate the need for repair services to be conducted outside routine business hours. All such arrangements shall be performed at no additional cost to the VA and coordinated between the contractor and VA laboratory personnel; equipment repair response time shall be no more than 24 hours

• Preventative maintenance will be performed as frequently as published in the manufacturer’s operator’s manual (1 PM per year required) and within 2 weeks of the scheduled due date.

• A malfunction service report shall be furnished to the laboratory upon completion of each repair call. The report shall include, as a minimum, the following:

o date and time notified o date and time of arrival o serial number, type and model of equipment o time spent for repair o parts consumed o proof of repair that includes documentation of a sample run of quality control verifying acceptable performance

SECURITY ADDENDUM

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 Veterans Affairs Department of 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 COTR.

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 COTR 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 $36.50 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-day’s 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– 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.

7. REFERENCE (S):

1. VA Affairs Handbook 6500, Risk Management Framework for VA Information Systems – Tier 3: VA Information Security Program, 10 Mar 2015.

2. Veterans Health Administration Procurement Manual (VHA PM) – 11/3/2014.

3. VA Handbook 1901.01, Health Information Management and Health Records – 19 Mar 15.

4. VHA Handbook 1605.5, Business Associate Agreements – 22 July 2014 5. Privacy Act of 1974 (5 U.S.C. 552a).

SECTION C - CONTRACT CLAUSES

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

C.1 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

(a) The Contractor agrees to comply with any provision or clause that is incorporated herein by reference to implement agency policy applicable to acquisition of commercial items or components. The following provisions and clauses that have been checked by the Contracting Officer are incorporated by reference.

[X] 852.203–70, Commercial Advertising.

[] 852.209–70, Organizational Conflicts of Interest.

[] 852.211–70, Equipment Operation and Maintenance Manuals.

[] 852.214–71, Restrictions on Alternate Item(s).

[] 852.214–72, Alternate Item(s). [Note: this is a fillable clause.]

[] 852.214–73, Alternate Packaging and Packing.

[] 852.214–74, Marking of Bid Samples.

[X] 852.215–70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors.

[X] 852.215–71, Evaluation Factor Commitments.

[] 852.216–71, Economic Price Adjustment of Contract Price(s) Based on a Price Index.

[] 852.216–72, Proportional Economic Price Adjustment of Contract Price(s) Based on a Price Index.

[] 852.216–73, Economic Price Adjustment—State Nursing Home Care for Veterans.

[] 852.216–74, Economic Price Adjustment—Medicaid Labor Rates.

[] 852.216–75, Economic Price Adjustment—Fuel Surcharge.

[] 852.219–9, VA Small Business Subcontracting Plan Minimum Requirements.

[] 852.219–10, VA Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside.

[] 852.219–11, VA Notice of Total Veteran-Owned Small Business Set-Aside.

[] 852.222–70, Contract Work Hours and Safety Standards—Nursing Home Care for Veterans.

[] 852.228–70, Bond Premium Adjustment.

[] 852.228–71, Indemnification and Insurance.

[] 852.228–72, Assisting Service-Disabled Veteran-Owned and Veteran-Owned Small Businesses in Obtaining Bonds.

[X] 852.232–72, Electronic Submission of Payment Requests.

[] 852.233–70, Protest Content/Alternative Dispute Resolution.

[] 852.233–71, Alternate Protest Procedure.

[] 852.237–70, Indemnification and Medical Liability Insurance.

[X] 852.246–71, Rejected Goods.

[] 852.246–72, Frozen Processed Foods.

[] 852.246–73, Noncompliance with Packaging, Packing, and/or Marking Requirements.

[] 852.270–1, Representatives of Contracting Officers.

[] 852.271–72, Time Spent by Counselee in Counseling Process.

[] 852.271–73, Use and Publication of Counseling Results.

[] 852.271–74, Inspection.

[] 852.271–75, Extension of Contract Period.

[] 852.273–70, Late Offers.

[] 852.273–71, Alternative Negotiation Techniques.

[] 852.273–72, Alternative Evaluation.

[] 852.273–73, Evaluation—Health-Care Resources.

[] 852.273–74, Award without Exchanges.

(b) All requests for quotations, solicitations, and contracts for commercial item services to be provided to beneficiaries must include the following clause:

[] 852.237–74, Nondiscrimination in Service Delivery.

(End of Clause)

C.2 VAAR 852.212-71 GRAY MARKET ITEMS (APR 2020)

(a) No gray market or remanufactured items will be acceptable. Gray market items are Original Equipment Manufacturers’ (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical equipment only for VA medical facilities.

(b) Vendor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system, verified by an authorization letter or other documents from the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

(End of Clause)

C.3 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING

AND COMPLIANCE (JUL 2018)

(a) This solicitation includes the clause: 852.215-70 Service-disabled veteran-owned and veteran-owned small business evaluation factors. Accordingly, any contract resulting from this solicitation will include the clause 852.215-71 Evaluation factor commitments.

(b) The Contractor is advised that in performing contract administration functions, the Contracting Officer may use the services of a support contractor(s) to assist in assessing Contractor compliance with the subcontracting commitments incorporated into the contract. To that end, the support contractor(s) may require access to the Contractor's business records or other proprietary data to review such business records regarding contract compliance with this requirement.

(c) All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the Contractor's business records or other proprietary data reviewed or obtained in the course of assisting the Contracting Officer in assessing the Contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs.

(d) Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the Contractor to protect proprietary information as required by FAR 9.505-4, Obtaining access to proprietary information, paragraph (b). The Contractor is required to cooperate fully and make available any records as may be required to enable the Contracting Officer to assess the Contractor compliance with the subcontracting commitments.

(End of Clause)

C.4 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT

2020) The Contracting Officer reserves the right to designate an Administrative Contracting Officer (ACO) for the purpose of performing certain tasks/duties in the administration of the contract.

Such designation will be in writing through an ACO Letter of Delegation and will identify the responsibilities and limitations of the ACO. A copy of the ACO Letter of Delegation will be furnished to the Contractor.

(End of Clause)

C.5 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

Material shall be packed for shipment in such a manner that will insure acceptance by common carriers and safe delivery at destination. Containers and closures shall comply with regulations of carriers as applicable to the mode of transportation.

(End of Clause)

C.6 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

http://www.acquisition.gov/far/index.html http://www.va.gov/oal/library/vaar/

FAR

Number

Title Date

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE OCT 2018

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE

MAINTENANCE

AUG 2020

52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL

BUSINESS SUBCONTRACTORS

NOV 2021

C.7 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)

(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. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered;

and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at Federal Acquisition Regulation (FAR) 52.233-1, Disputes, which is incorporated…