Solicitation 36C25620Q1000.pdf

PAGE 1 OF1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. DUNS: DUNS+4:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C25620Q1000 08-07-2020

Lakeisha White 601296-6959 08-28-2020 Noon

00586 Department of Veterans Affairs G.V. (Sonny) Montgomery VAMC

1500 E. Woodrow Wilson Dr.

Jackson MS 39216

X

334516

1000 Employees

N/A

X

00586

Department of Veterans Affairs Various VISN 16 Facilities

10N16

G.V. (Sonny) Montgomery VAMC A&MM Service (90C) 715 South Pear Orchard Road Ridgeland MS 39157

Financial Service Center PO Box 149971 Austin TX 78714 9971

See CONTINUATION Page

See CONTINUATION Page

X

Clay Jones

36C25620Q1000

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

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)

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

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

C.3 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND

COMPLIANCE (JUL 2018)

C.4 VAAR 852.219-76 SUBCONTRACTING PLANS MONITORING AND

COMPLIANCE (JUL 2018)

C.5 VAAR 852.219-71 VA MENTOR-PROTÉGÉ PROGRAM (DEC 2009)

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

C.7 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JUN 2020)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (OCT 2018)

E.2. SUBMISSION OF QUOTE

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (DEC 2019)

E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.4 52.216-1 TYPE OF CONTRACT (APR 1984)

E.5 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.6 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.7 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.8 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL ITEMS (JUN 2020)

E.9 52.219-8 UTILIZATION OF SMALL BUSINESS CONCERNS (OCT 2018)

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

Department of Veterans Affairs

G.V. (Sonny) Montgomery VAMC

1500 E. Woodrow Wilson Dr.

Jackson MS 39216

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other []

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

Department of Veterans Affairs

Financial Service Center

PO 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

VISN 16 Telepathology System

STATEMENT OF OBJECTIVES

Intent. The Department of Veterans Affairs, South Central Veterans Integrated Service Network 16 (hereafter referred to as VISN 16) intends to purchase a whole slide imaging, scanning, and digital pathology system for eight VA Medical Centers as listed in Table 1.

Background. Pathology Services are an integral part of any modern medical center operations and are a vital component in the overall evaluation, diagnosis, and treatment of many different diseases. The need for trained, highly skilled Pathologists to interpret slides for diagnosis and to consult with other Pathologists in a timely manner cannot be overstated in relation to effective patient care.

Across the Department of Veterans Affairs (VA), Veterans Health Administration (VHA), several facilities have experienced difficulties in maintaining Pathologists on staff in sufficient numbers to effectively keep up with the patient workload. When this happens, slides must be sent to outside providers for reading and diagnosis, which is less efficient, less timely, and less cost-effective than reading within the VA. Sending slides outside the VA also inserts additional risks to patient care, as slides may be lost or damaged in transit. As an alternative to relaying on outside providers, some Veterans Integrated Service Networks (VISNs) and facilities have purchased Telepathology systems that can be used for either primary diagnosis or for consultation and confirmation of diagnosis.

The VAMC in New Orleans has an intra-facility Telepathology system that was implemented several years ago. VISN 16 seeks to implement a new inter-facility Telepathology system for all its facilities. This new system will allow slides to be placed into the Telepathology system from any facility to be read for either primary diagnosis or secondary consultation as needed by another Pathologist at another VISN 16 facility.

Purpose. VISN 16 requires a Telepathology system that can be used to remotely provide Pathologist consultation and/or primary diagnosis as needed between facilities. The ideal solution will be fast performing and intuitive to use, thereby minimizing the time needed to load, scan, and/or transmit slides.

Scope. VISN 16 intends to award a single Delivery Order with Options to the overall best-value contractor capable of meeting the requirements and objectives outlined herein for a Telepathology system, the associated installation and configuration services, and the incorporated staff training requirement. This delivery order requirement will consist of software and servers; hardware such as cameras, slide sorters, and diagnostic monitors; the implementation, testing, and training of the new system at all applicable facilities; and the ability to interface and integrate with the existing systems.

Offerors must demonstrate the performance capabilities detailed throughout this document

The tissue slide scanners, image analysis software, storage servers, and compatible operating system permits large scale archived collections of histopathology specimens that require an image library for historical archives, remote consultation, and digital preservation of patient specimens that have been referred for outside consultation. These specimens would be irreplaceable if lost. This system will allow VISN 16 to evaluate specimens and generate data from multiple specimens concurrently.

Functionality will include whole slide digital scanning, documentation, remote consultation, specialty consultation, and computer assisted digital image analysis. The quality of the product must be suitable for basic surgical and cytopathology functions including, but not limited to the following: consultative services; second review for newly diagnosed malignancies; coverage for pathologist absences; quality assurance review, Joint Pathology Center consultations, and support for tumor boards. In addition, the system must comply with the Federal Drug Administration (FDA) guidance, Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices issued April 20, 2016. Finally, specific facilities as detailed in Table 2 will require a slide scanning system that is FDA certified for use in primary diagnosis and the VISN-wide system must facilitate this capability; i.e. a site that does not require an scanner that is FDA certified for use in primary diagnosis must still be able to read a slide for primary diagnosis that was input by a facilities that is using a scanner that is FDA certified for use in primary diagnosis.

Period of Performance. The period of performance shall be one (1) twelve (12) month base period plus four (4) additional twelve (12) month option periods for service maintenance support.

Hours of Coverage & Federal Holidays. Maintenance Service will be provided during regular coverage hours of 8:30am to 5:30pm, Monday through Friday, excluding federal holidays. The contractor shall contact the POC or his/her designee prior to commencing any work on the premises. Federal Holidays are:

New Years' Day Martin Luther King Day Presidents' Day Memorial Day Independence Day Labor Day Columbus Day Veterans' Day Thanksgiving Day Christmas Day

Place of Performance. Contract performance shall take place at the contractor’s location(s) and at the VISN 16 locations shown in Table 1.

Table 1. VISN 16 Facilities Facility Address

Alexandria Veterans Health Care System 2495 Shreveport Hwy

Pineville, LA 71360

Gulf Coast Veterans Health Care System 400 Veterans Avenue Biloxi, MS 39531

Veterans Health Care System of the Ozarks 1100 N. College Avenue Fayetteville, AR 72703

Michael E. DeBakey VA Medical Center 2002 Holcombe Blvd

Houston, TX 77030

G.V. (Sonny) Montgomery VA Medical Center 1500 E. Woodrow Wilson Drive Jackson, MS 39216

Central Arkansas Veterans Healthcare System John L. McClellan Memorial Veterans Hospital

4300 West 7th Street Little Rock, AR 72205-5484

Southeast Louisiana Veterans Healthcare System

2400 Canal Street

New Orleans, LA 70119

Overton Brooks VA Medical Center 510 E. Stoner Ave.

Shreveport, LA 71101-4295

The requirements and objectives for the VISN 16 Telepathology system are detailed below. Offerors shall provide a statement of work that includes narrative descriptions of how they will meet these requirements and objectives.

System Performance Requirements. The items in this section are specific requirements that must be met by this acquisition and are not merely acquisition & performance objectives. The offeror shall provide narrative descriptions of how these requirements will be met:

1. The Contractor shall provide necessary equipment and upgradable digital slide image viewing software that gives facilities covered by this contract the ability to both scan slides into the Telepathology system and read slides scanned in by other covered facilities, to include providing “in-house” Telepathology services intra-facility.

2. The Contractor shall provide the necessary hardware, computer workstations, operating systems, driver software, appropriately sized servers and storage, and displays required to operate scanners as well as all necessary cables to connect and power unit components.

Operating system software shall be currently sold and supported by its original manufacturer.

Operating systems must meet all VA regulations and specifications and must be the current version approved by OIT.

3. The Contractor shall provide new and latest state-of-the-art equipment and software versions for each of the clinical laboratories at the facilities listed in this SOW. This hardware and software shall not interfere with operations of the laboratory nor with software systems already in place, including, but not limited to VistA/CPRS and Microsoft Office applications.

4. The Contractor shall provide an uninterruptible power supply (UPS) with line conditioner for each instrument provided. Each UPS must provide electrical power for a minimum of 15 minutes after electrical power fails and the system must allow for an automatic controlled shutdown to prevent damage to the instrument and data records.

5. The Telepathology system shall meet FDA requirements outlined in the "'Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices issued on April 20, 2016.

6. VistA Integration – The Telepathology system shall accept and filter information from VistA to allow views of VistA ADT data elements. Proposed solution shall have an HL7 interface capable of accepting patient demographic information (ADT) and order (ORM) messages received from VistA.

7. The Telepathology system shall provide the ability to integrate slide images with VistA Imaging/CPRS for documenting into the permanent patient record.

8. Cerner Integration – The Telepathology system shall accept and filter from Cerner to allow views of Cerner data elements i.e. labs, ADT. Proposed solution shall have an HL7 interface capable of accepting patient demographic information (ADT) and order (ORM) messages received from the Cerner scheduling package. These data elements shall be provided in real time and updated automatically.

9. Cerner Transitions Services – Contractor shall provide integration and migration services to migrate the connectivity from VistA to the Cerner platform.

10. All hardware and software shall comply with OIT TRM, network security, and Enterprise Risk Analysis requirements. Failure to obtain TRM and OIT network connectivity approval within 75 days of award (extendable if significant progress is being made) shall be cause for termination.

11. All facilities shall be able to scan, upload and share images through a central server for intra-VISN consultations and diagnoses.

12. The system shall be certified FDA compliant for H&E primary diagnosis at or within 90 days after award, for those facilities who require scanners that are FDA certified for use in primary diagnosis.

a. Failure to obtain FDA certification within 90 days of award (extendable at the Governments sole discretion if significant progress is being made) shall be cause for termination.

b. As an alternative to termination for failure to obtain FDA certification for primary diagnosis within 90 days, the Contractor may, at the Government’s sole discretion, install a system that is pending FDA certification for use in primary diagnosis at those facilities that require it for a period of up to one year. The Contractor shall understand and agree that all hardware or software costs required to upgrade the installed system upon receipt of FDA certification shall be the responsibility of the Contractor and that further failure to obtain FDA certification for primary diagnosis at the end of this one year period shall be cause for termination.

13. The software shall permit remote viewing by only VA approved users accessing secure network servers by unique password logging. The software shall not be limited to any proprietary image formats but permit viewing of digital slides generated on other platforms. The vendor will provide software upgrades at no additional charge as needed to correct or improve functionality in accordance with warranty and service agreements.

14. The implementation of the services/requirements described in this solicitation shall be completed no later than 280 days after the award of the Award. This timeline is based on a reasonable attempt of the Contractor to complete all the necessary implementation requirements within the stated timeframe. Contractor shall not be penalized for implementation timelines that extend beyond the 180-day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government.

15. The Contractor shall provide on-site staff training on use and maintenance of instrumentation

16. The Contractor shall provide on-site provider training of software used for diagnosis

17. The Contractor software shall have logarithms that provide staining percentages of scanned slides.

18. The Telepathology software and/or scanning instrument shall be upgradable via software, base scanner add-ons or both that allow future expansion of the instrument to include cytology, frozen section and direct immunofluorescence as they become available.

19. The system shall have a means of purging stored scanned images at set intervals unless otherwise marked as “keep” or “save”.

20. The system shall have a means to save a static JPG format image for placing in the patient’s medical chart.

21. The system shall integrate with the current LIS in use at the facilities.

Performance Objectives. This section details performance objectives that VISN 16 seeks to meet with this contract. Offerors shall provide a statement of work (SOW) with their response that addresses qualitatively and/or quantitatively how they will meet these objectives. VISN 16 desires:

1. A Telepathology system that is fast, intuitive, and easy to use for users at both ends of the telepathology reading and that includes a simple means to correct clerical entry errors and replace suboptimal scans.

2. A system that provides Integration with viewer software to allow the scanner operator to assign individual cases to one or more local or remote pathologists for viewing.

3. Fully automated Load and Walkaway functionality.

4. Capability for Z-stacking

5. A satisfactory calibration test method that conforms with International Standards, if applicable.

6. Satisfactory system level assessments including:

a. Color reproducibility

b. Spatial resolution

c. Focusing tests

d. Whole slide tissue coverage

e. Stitching error

7. A comprehensive Contractor provided on-site instrument training program that is coordinated with and timely to the equipment installation and that includes initial on-site training for scanner operators, pathologists, and clinical engineering staff. Supplemental advanced training and continuing educational opportunities provided by the vendor will be considered an additional benefit.

8. Electronic Standard Operating Procedure (SOP) for both the operation of the device and maintenance that are customized at each site, along with standard electronic training manuals and materials.

9. A Contractor- provided configuration and testing plan, with the documentation related to VistA interfaces, installing patches, test scripts, installation and user guides, implementation and back out plan.

10. A complete hardware and software warranty that meets or exceeds the industry standard for this type of system, both in level of coverage and warranty period. This warranty should include, at no additional charge, any and all equipment service programs, such as remote diagnostics and equipment replacement, during the warranty period.

11. A cost-effective option to extend the post-warranty remote diagnostic service and replacement equipment program on an annual basis for the entire four option year periods.

12. The ability for all facilities in VISN 16 to read Pathology slides for any other site in VISN 16 for either primary diagnosis or consult as needed and in accordance with the site-specific equipment objectives in Table 2. For example, a single pathologist in Little Rock could read a slide that was scanned in locally (not for primary diagnosis) and then be sent one as a consult from Jackson (not for primary diagnosis) and then read one from Alexandria (for primary diagnosis)…all at the same reading station during the same session. The contractor should address if and how this could be accomplished using their system.

13. Software for image analysis software with ability to measure specific areas and perform counts.

14. The ability for workstation "image preview" by the scanner operator to assess image quality and accurate identifying information before upload to servers for remote access.

15. A scan speed of 90 seconds or less for a 20x scan (15x15mm) or 155 seconds or less for a 40x scan (15xl5mm).

16. Ability to read barcoded slides and interface with a whole slide manager and a barcode reading accuracy rate of 99% or greater.

17. End user daily, weekly, etc., maintenance that is intuitive and does not require an inordinate amount of time to perform.

18. Ability to move annotation lines once drawn by dragging and without having to erase and redraw. Ability to continue the same annotation line after stopping and starting again.

19. Figure maker capabilities that automatically format presentation, number images, add correct scale bars and reference frames for each image with a click of a button; and include up to 9 images.

20. The ability to save, review, and display multiple file formats to include: JPG, JPEG, TIFF, JPEG2000 compression standard or TIFF.

21. Ability to add oil immersion lenses

22. A notification (''work list") of cases assigned to a pathologist user upon his/her logging into the local or remote server.

23. Software that provides capacity for creating storable annotations of images.

Table 2. Site Specific Equipment Objectives Facility Address

Alexandria Veterans Healthcare System 2495 Shreveport Hwy Pineville, LA 71360

-One small slide scanning system that is FDA certified for use in primary diagnosis

-One reading station that is FDA certified for use in primary diagnosis

Gulf Coast Veterans Healthcare System 400 Veterans Avenue Biloxi, MS 39531

-One small slide scanning system that is FDA certified for use in primary diagnosis

-One reading station that is FDA certified for use in primary diagnosis

Veterans Healthcare System of the Ozarks 1100 N. College Avenue Fayetteville, AR 72703

-One multi-slide slide scanning system that is FDA certified for use in primary diagnosis

-One reading station that is FDA certified for use in primary diagnosis

Michael E. DeBakey VA Medical Center 2002 Holcombe Blvd Houston, TX 77030

One reading station that is FDA certified for use in primary diagnosis

G. A. Sonny Montgomery VA Medical Center 1500 E. Woodrow Wilson Dr. Jackson, MS 39216

-One small slide scanning system

-One reading station that is FDA certified for use in primary diagnosis

Central Arkansas Veterans Healthcare System 4300 West 7th Street Little Rock, AR 72205-

-One multi-slide scanning system

- One reading station that is FDA certified for use in primary diagnosis

Southeast Louisiana Veterans Healthcare System 2400 Canal Street New Orleans, LA 70119

One reading station that is FDA certified for use in primary diagnosis

Overton-Brooks VA Medical Center 510 E.

Stoner Ave. Shreveport, LA 71101-4295

-One multi-slide slide scanning system that is FDA certified for use in primary diagnosis

-Two reading station that are FDA certified for use in primary diagnosis

Privacy, Security, and Records requirements. All Offerors shall submit a fully completed VHA form 6550 with their submission package. The device shall be able to obtain 6550 security clearance and enterprise risk analysis approval. All software utilized must be included on the approved Technical Reference Model website (TRM). Contractors who remotely access the device tor maintenance, patching, troubleshooting, and so forth shall comply with VA security regulations.

Additional Contractor Security and Privacy Requirements from VA Handbook 6500.6 are listed below.

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.

a. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS-

i. 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.

ii. 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.

iii. 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.

iv. 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.

v. 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.

b. VA INFORMATION CUSTODIAL LANGUAGE –

i. 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).

ii. 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.

iii. 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.

iv. 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.

v. 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.

vi. 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.

vii. 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.

viii. 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.

ix. 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.

x. 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.

xi. 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.

xii. 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.

c. SECURITY INCIDENT INVESTIGATION-

i. 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.

ii. 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.

iii. 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.

iv. 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.

d. LIQUIDATED DAMAGES FOR DATA BREACH-

i. 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.

ii. 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.

iii. 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:

o date of occurrence;

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

o Number of individuals affected or potentially affected;

o Names of individuals or groups affected or potentially affected;

o 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;

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

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

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

o Assessment of the potential harm to the affected individuals;

o Data breach analysis as outlined in 6500.2 Handbook, Management of

Security and Privacy Incidents, as appropriate; and o 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.

iv. 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.

e. TRAINING –

i. 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:

• 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;

• Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

• Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

• 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.]

ii. 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.

iii. 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.

f. C&A REQUIREMENT- The C&A requirements do not apply and a Security Accreditation Package is not required for this contract.

i. VA sensitive information will be protected through the exclusive use of VA owned and operated equipment for performance of services under this contract.

ii. Contractor personnel shall be required to submit to background investigations, obtain a PIV card, and complete the required TMS training certificates.

2. MEDICAL RECORDS

a. Authorities: Contractor’s physician (s) providing healthcare services to VA patients shall be considered as part of the Department Healthcare Activity and shall comply with the U.S.C.551a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of certain medical records), Title 5 U.S.C. § 522a (Records Maintained on Individuals) as well as 45 C.F.R. Parts 160, 162, and 164

(HIPAA).

b. HIPAA: This contract and its requirements meet exception in 45 CFR 164.502(e), and do not require a BAA in order for Covered Entity to disclose Protected Health Information to: a health care provider for treatment. Based on this exception, a BAA is not required for this contract. Treatment and administrative patient records generated by this contract or provided to the Contractors by the VA are covered by the VA system of records entitled ‘Patient Medical Records-VA’ (24VA19). Contractor generated VA Patient records are the property of the VA and shall not be accessed, released, transferred, or destroyed except in accordance with applicable laws and regulations.

Contractor shall ensure that all records pertaining to medical care and services are available for immediate transmission when requested by the VA. Records identified for review, audit, or evaluation by VA representatives and authorized federal and state officials, shall be accessed on-site during normal business hours or mailed by the Contractor at his expense. Contractor shall deliver all final patient records, correspondence, and notes to the VA within twenty-one (21) calendar days after the contract expiration date.

c. Disclosure: Contractor’s physician(s) may have access to patient medical records:

however, Contractor shall obtain permission from the VA before disclosing any patient information. Subject to applicable federal confidentiality or privacy laws, the Contractor, or their designated representatives, and designated representatives of federal regulatory agencies having jurisdiction over Contractor, may have access to VA ‘s records, at VA’s place of business on request during normal business hours, to inspect and review and make copies of such records. The VA will provide the Contractor with a copy of VHA Handbook 1907.01, Health Information Management and Health Records and VHA Directive 1605.01, Privacy and Release of Information. The penalties and liabilities for the unauthorized disclosure of VA patient information mandated by the statutes and regulations mentioned above, apply to the Contractor.

d. Professional Standards for Documenting Care: Care shall be appropriately documented in medical records in accordance with standard commercial practice and guidelines established by VHA Handbook 1907.01 Health Information Management and Health Records: https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3233 and all guidelines provided by the VAMC.

e. Release of Information: The VA shall maintain control of releasing any patient medical information and will follow policies and standards as defined, but not limited to Privacy Act requirements. In the case of the VA authorizing the Contractor to release patient information, the Contractor in compliance with VA regulations, and at his/her own expense, shall use VA Form 3288, Request for and Consent to Release of Information from Individual’s Records, to process “Release of Information Requests.” In addition, the Contractor shall be responsible for locating and forwarding records not kept at their facility. The VA’s Release of Information Section shall provide the Contractor with assistance in completing forms. Additionally, the Contractor shall use VA Form 10-5345, Request for and Authorization to Release Medical Records or Health Information, when releasing records protected by 38 U.S.C. 7332. Treatment and release records shall include the patient’s consent form. Completed Release of Information requests will be forwarded to the VA Privacy Officer.

Travel for Installation, Implementation and Training. The Government anticipates Contractor travel under this contract. All travel shall be incorporated into the overall firm fixed price for the contract. No travel costs will be reimbursed by VA. Travel is anticipated for on-site installation, implementation, initial “Go Live” training, refresher training and ongoing training (every six months) at all locations shown in Table 1. The Government acknowledges the possible use of remote access for installation and implementation purposes, within the constraints of all applicable VA Information Security Requirements.

Government Furnished Equipment/Information. The Contractor shall be allowed access to Government equipment including servers and network infrastructure. Information on Government equipment and systems shall be provided as necessary. No Government-owned property will be transferred into the Contractor’s control. Additional software products may be provided by the Government as identified to facilitate Contractor access.

Invoicing. Invoices shall be submitted electronically via the Financial Services Center Mandatory Electronic Invoice System, on a monthly basis. Invoices must include, at a minimum, the following information: Contractor name, purchase order number, period of service the billing covers, and a list of equipment items covered during the stated period of performance. This requirement is in accordance with VARR Clause 852.232-72 Electronic Submission of Payment Requests:

http://www.fsc.va.gov/einvoice.asp. Electronic payments are net 30 days.

For requirements items, the prices applicable during the short-term extension(s) shall be the prices applicable during the immediately succeeding option period, if there is one. If there is no succeeding option period, the prices shall be the prices applicable during the immediately preceding contract period. The cost ceiling(s), base fee(s), and award fee(s) during the short term option(s) shall be the pro rata portion of the costs and fees applicable to the immediately succeeding option period, if there is one. If there is no succeeding option period, the cost ceiling(s) and fee(s) shall be the pro rata portion of the costs and fees for the immediately preceding contract period.

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMB

ER

DESCRIPTION OF

SUPPLIES/SERVICES

QUANTIT

Y UNIT UNIT PRICE AMOUNT

0001 1.00 EA _____________

Complete Telepathology System (hardware, software, storage, implementation, training, and support) for eight VAMCs in VISN 16.

GRAND TOTAL _____________

B.3 DELIVERY SCHEDULE

ITEM NUMBER

QUANTIT

Y

DELIVERY

DATE

0001 1.00

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.