Attachment A - Combined Synopsis Solicitation 36C24821Q0922 (1).pdf

COMBINED SYNOPSIS/SOLICITATION RFQ 36C24821Q0922

General Information Action Code:

Document Type:

RFQ Number:

Posted Date:

Response Date:

Classification Code:

Set Aside:

NAICS Code:

Combined Synopsis

Solicitation

RFQ

36C24821Q0922

05/10/2021

05/21/2021 by 4:30PM

Service-Disabled Veteran Owned Small Business 334510

Contracting Office Address

NCO 8

ATTN: James Blue 300 E. University Ave. STE 170 Gainesville, FL 32601-3460

Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6 in conjunction with Part 13, as supplemented with additional information included in this notice. This procurement is being conducted under Subpart 13.5 Simplified Procedures for Certain

Commercial items. This announcement constitutes the only solicitation for this action. Quotes are being requested, and a written solicitation will not be issued.

This solicitation is issued as a Request for Quote (RFQ). This solicitation document and incorporated provisions and clauses are those in effect through Federal

Acquisition Circular (FAC) 2021-05 effective 03/10/2021.

The Network Contracting Office 8-RPO East intends to award a firm fixed priced contract for Thromboelastograph (TEG) analyzers and analyzer manager software with remote viewer for OR and Laboratory in accordance with the below Statement of Need (SON) and attached Price Schedule.

The associated North American Industrial Classification System (NAICS) code for this procurement is 334510 – Electromedical and Electrotherapeutic Apparatus

Manufacturing with a small business size standard of 1,250 Employees.

Prospective offerors shall be a registered in the System for Award Management

(SAM) at http://www.sam.gov to be considered for an award of a federal contract, and registration shall be complete and not missing elements such as representations and certifications.

For evaluation purposes, to be considered as a Service Disabled Veteran Owned

Small Business (SDVOSB), prospective offerors shall be a verified SDVOSB in the http://www.sam.gov/

VA Center for Verification and Evaluation (CVE) Veteran Information Pages

(VIP) pages Home · VetBiz Portal (va.gov) at the date and time set for receipt of offers.

You are reminded that representatives from your company SHALL NOT contact any North Florida/South Georgia VA Health Care System staff to discuss this RFQ during this RFQ process. All questions and concerns regarding this RFQ shall be directed to James Blue, the Contracting

Officer.

QUOTE SUBMISSION: Offers are due on/or before Tuesday

05/21/2021 by 4:30 PM Eastern. Quotes shall be sent by e‐mail

“only” to the Contracting Officer (James Blue) at james.blue3@va.gov.

The Government will award a Firm Fixed Priced (FFP) contract resulting from this RFQ to the responsible offeror whose quote is

Technically Acceptable and whose quote offers the best value to the

Government utilizing the comparative evaluation procedures IAW FAR

13.106-2 (3). Quotes shall include:

(1) Technical: The Technical Subfactors will be evaluated and rated either Acceptable or Unacceptable. For a quotation to be rated overall Technically Acceptable, each of the following subfactors must be rated Acceptable.

a. Subfactor 1: Meet Salient Features and Characteristics as outlined in the Salient Characteristics Section of the Statement of Need.

(2) Delivery: Provide your best performance schedule with the delivery date clearly labeled.

(3) Price: Offerors shall quote prices for required supplies listed in the Statement of Need by completing all pricing in attached Price Schedule. The completed Price Schedule must be submitted with the offerors final quote.

***ALL RECEIVED QUOTES MUST INCLUDE AS AN ATTACHMENT THE AUTHORIZED

DISTRIBUTOR LETTER***

https://vetbiz.va.gov/ mailto:james.blue3@va.gov

36C24821Q0922

Table of Contents

Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT

2018) 16

C.2 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

C.3 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING— MONITORING AND

COMPLIANCE (JUL 2018)

C.4 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)

C.5 VAAR 852.247-72 MARKING DELIVERABLES (OCT 2018)

C.6 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

C.7 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

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

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2021) (JUL 2020)

(DEVIATION)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (JUN 2020) . 34

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (OCT 2020)

E.3 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998) 41

E.4 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.5 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL ITEMS (FEB 2021) (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 36C248

Department of Veterans Affairs

Network Contracting Office 8 (NCO 8)

Commerce Building

300 E. University Ave. Ste. 180

Gainesville FL 32601-3460

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] 30 Days After Installation and Receipt of Installation

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.

Financial Services Center

P.O. Box 149971

Austin TX 78714-9971

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

AMENDMENT NO DATE

DEPARTMENT OF VETERAN AFFAIRS

STATEMENT OF NEED

A. GENERAL INFORMATION

1) Title of Project: Thromboelastograph (TEG) analyzers and analyzer manager software with remote viewer for OR and Laboratory.

2) Scope of Work: The Department of Surgery, Department of Anesthesia, and the Pathology &

Laboratory Medicine Services located in Malcom Randall VA Medical Center (VAMC) in

Gainesville, Florida have a requirement to acquire two TEG analyzers for the accurate identification of a patient’s hemostasis condition in a laboratory or site of care testing that will assist the provider to drive treatment and administration of blood products. A management software with their respective licenses compatible with the analyzer will be needed as well for the management of data, quality assurance program, and remote viewer of active and previous test results. . The Contractor shall provide all resources necessary to accomplish the deliverables described in this Statement of Need

(SON), except as may otherwise be specified.

3) Background: The Thromboelastography (TEG) Hemostatis Analyzer uses a small whole blood sample and records the viscoelastic changes that occur as a sample of whole blood or platelet-rich plasma clots, retracts and/or lyses. The resulting graph measures the kinetics of clot formation, dissolution and clot quality. These parameters reflect the processes of hemostasis and coagulation.

The TEG monitors shear elasticity, is sensitive to all the interacting components in the blood that may affect the rate of structure of a clotting sample and its breakdown. The overall profile can be qualitatively or quantitatively interpreted in terms of the hypo, normal, or hypercoagulable state of the sample and degree of lysis. The graph is the representation of the hemostasis curve, which depicts clot firmness over time. System includes the TEG unit with printer and scanner plus TEG manager software license fee - if software approved - able to view live in surgery.

This is useful in anesthesia practice as it can predict and manage coagulopathies that patients experience in the pre, intra and post-operative phases of their hospital course. It has been shown to help assess risk for re-operation and aid in the management of blood transfusions, greatly reducing unnecessary blood component use and transfusion. Goal directed replacement therapy will decrease unnecessary exposure of our patients to blood products.

Viscoelastic coagulation testing (TEG and ROTEM) is now in widespread use in cardiac surgery, neurosurgery, vascular surgery, transplant surgery, trauma surgery and in surgical intensive care units1. Coagulopathy and severe bleeding are associated with high mortality, and these tests have proven valuable in the rapid diagnosis of clotting disorders. Current coagulation tests including activated partial thromboplastin time (aPTT) and prothrombin time (PT/INR) have limited utility to diagnose early coagulopathies and direct their treatment. Neither test accurately predicts the extent of bleeding in critically ill or trauma patients, and a recent systematic review concluded that they are now inappropriate for use in the trauma patient2. The current cell-based understanding of hemostasis, which emphasizes the roles of tissue factor (TF) and platelet activation, challenges the traditional clotting cascade concept. The cell-based model and the need for shorter turnaround time in the coagulopathic and/or actively bleeding patient has prompted the widespread adoption of viscoelastic coagulation testing. Furthermore, with patients now using a variety of novel oral anticoagulants that complicate perioperative care, the ability of viscoelastic coagulation testing to accurately identify and monitor the effects of these agents is becoming very important. While there are no large-scale randomized controlled trials evaluating TEG against traditional coagulation testing, the preponderance of evidence now supports the use of TEG to both minimize transfusion requirements in surgical patients and to improve outcomes after major surgery 4 to 8. While TEG coagulation testing is available to clinicians at the NF/SG VAMC, it is a send-out test to the

University of Florida laboratory with variable turnaround time, on average almost 3 hours and as long as 7 hours. This length of turnaround time eliminates one of the primary advantages of on-site

TEG testing: very rapid usable clinical results. It also explains why the send-out test is so infrequently used by NF/SF VAMC clinicians. The NF/SG VAMC has the 3rd largest cardiac surgery program (by volume) in the VA system, and very active vascular and neurosurgery programs. Perioperative bleeding is a common and feared complication with which we all deal.

With the availability of in-house TEG testing our VA surgeons would have much better guidance about which component of the clotting system is disrupted, which would allow us to tailor blood product transfusion much more accurately. Blood product ordering and utilization would both fall, and outcomes would improve.

4) Delivery:

a) The Contractor shall install all deliverables required under this SOW within thirty (30) calendar days or less from the date of award, unless otherwise directed by the Contracting Officer (CO).

See Installation section for installation requirements.

b) Delivery of the analyzers and supplies shall be made to

Malcom Randall VA Medical Center – Warehouse

1601 SW Archer Rd.

Gainesville, FL 32608

c) Delivery shall be made during normal Malcom Randall VAMC warehouse business hours excluding all federal holidays.

i) Malcom Randall VAMC warehouse business hours are Monday – Friday, 8:00 am – 4:30 pm.

ii) Federal holidays are: New Year’s Day, Martin Luther King Jr. Day, President’s Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving

Day, and Christmas Day.

B. SALIENT CHARACTERISTICS

1) The Thromboelastography (TEG) Hemostatis Analyzer System:

a) TEG Analyzer:

i) Must be a device that can be used in the laboratory or point of care setting (bed side)

ii) Analyzer provides rapid comprehensive and accurate identification of a patient’s hemostasis condition

iii) Test preparation without complex pipetting and mixing of sample.

iv) The analyzer must be vibration resistant. Analyzer can be moved while processing test results.

v) The analyzer must perform processing of multiple assays simultaneously from a small blood sample.

vi) The analyzer must use a self-contained multichannel cartridge test that should provide testing for:

(a) Kaolin TEG

(b) Kaolin TEG with heparinase

(c) Rapid TEG

(d) TEG functional Fibrinogen

vii) The analyzers have a self-monitoring quality control

viii) The analyzer must have a small footprint for easy transport (weight 10 pounds or less.

ix) The analyzer operative system that complies with current Veterans Health Administration

(VHA) security requirements. Windows 10 is the standard.

x) The test results must be available within minutes.

xi) The company must provide management software compatible with the analyzers that allows for remote results viewing and device administration for remote access to active results and to analyzers for troubleshooting or production of usage and quality reports.

xii) Instrument must be compatible with the current Data Innovations Laboratory Instrument

Software (LIS) and able to interface for the transmittal of results to the Computerize Patient

Record System (CPRS) and the Veterans health Information Systems and Technology

Architecture (VISTA).

xiii) Should include two (2) Scanners and two (2) Printers, USB.

b) TEG Management Software:

i) The management software must be provided by the same company as the analyzer and fully compatible with the TEG devices.

ii) The management software must comply with VA software security requirements

iii) The software must allow remote viewing of diagnostic data from the TEG analyzer

iv) The software is web-based platform that serves as a central repository for test data in a VA secured server.

v) The software must provide connectivity for management and oversight of all connected TEG analyzers, no matter where they are in the medical center via network connection data port.

vi) The software needs to provide viewing of active TEG tests from TEG devices anywhere in the hospital.

vii) Provides manager software capable of communication with our Laboratory Information system (LIS), Data Innovation using HL7 format

2) Installation and validation:

a) Installation shall be performed by technicians authorized by the company selected.

b) Onsite installation shall begin no later than 30 calendar days following contract award.

c) Installation shall be coordinated with the designated COR. Please provide notice at least 5 business days in advance.

3) Training: Onsite training must be provided to at least 4 super users. The training must cover device, management software, interpretation of tracings, and any information necessary for the successful utilization of the device.

4) Test and Acceptance: All deliverables shall be tested and accepted by VA personnel.

REQUIRED LANGUAGE FOR INCLUSION IN SOW FOR CONTRACTS THAT REQUIRE

ACCESS TO A VA SYSTEM OR VA SENSITIVE INFORMATION

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 COTR.

4. 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.

5. 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:

• Nature of the event (loss, theft, unauthorized access);

• Description of the event, including:

• date of occurrence;

• data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;

• Number of individuals affected or potentially affected;

• Names of individuals or groups affected or potentially affected;

• 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;

• Amount of time the data has been out of VA control;

• The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);

• Known misuses of data containing sensitive personal information, if any;

• Assessment of the potential harm to the affected individuals;

• Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and

• 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 $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

• Notification;

• One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;

• Data breach analysis;

• Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;

• One year of identity theft insurance with $20,000.00 coverage at $0 deductible;

and

• Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

6. 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 n of all physical h time as the 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 terminatio APPENDIX B or electronic access privileges and removal from work on the contract until suc training and documents are complete.

Required Privacy Training for all Vender Employees

Talent Management System (TMS) Self – Enrollment Instructions link:

http://vaww.visn8.portal.va.gov/northflorida/cos/education/shared/MSE-Profile-Creation-

Contractors-JobAid-508.pdf

Required Classes:

• VA Privacy and Information Security Awareness Training and Rules of Behavior

(VA10176)

• Privacy and HIPAA Focused Training PowerPoint Presentation 2017 (VA10203) http://vaww.visn8.portal.va.gov/northflorida/cos/education/shared/MSE-Profile-Creation-Contractors-JobAid-508.pdf http://vaww.visn8.portal.va.gov/northflorida/cos/education/shared/MSE-Profile-Creation-Contractors-JobAid-508.pdf

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM DESCRIPTION OF

NUMBE SUPPLIES/SERVI QUANTI UNI

R CES TY T UNIT PRICE AMOUNT

0001 2.00 EA

Thromboelastograph (TEG) analyzers and analyzer manager software with remote viewer for OR and Laboratory IAW Statement Of Need PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

GRAND TOTAL

B.3 DELIVERY SCHEDULE

ITEM NUMBER

QUANTITY

DELIVERY

DATE

0001 SHIP TO: Malcom Randall VA Medical Center

ATTENTION: PLMS

1601 S.W. Archer Road Gainesville, FL 32608 1197

USA

2.00 NLT 30 DAYS

ARO

MARK

FOR:

Sandra Pascual 352-548-6000 x5336 Sandra.Pascual@va.gov mailto:Sandra.Pascual@va.gov

SECTION C - CONTRACT CLAUSES

C.1 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. 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 FAR 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the

Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the

Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by

Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt

Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-

5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting

Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the

Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in 32.608-2 of the Federal Acquisition Regulation in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the

Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The

Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the

Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain

Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 41 U.S.C. 4712 and 10 U.S.C. 2409 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and

41 U.S.C. chapter 21 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with

Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;

(3) The clause at 52.212-5.

(4) Addenda to this solicitation or contract, including any license agreements for computer software.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments

(9) The specification.

(t) [Reserved]

(u) Unauthorized Obligations.

(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service

(TOS), or similar legal instrument or agreement, that includes any clause requiring the

Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:

(i) Any such clause is unenforceable against the Government.

(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.

(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.

(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

(v) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

(End of Clause)

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

ITEMS

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.2 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.

[] 852.215–70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business

Evaluation Factors.

[] 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.

[X] 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…