36C24819Q1045-001.docx

36C24819Q1045

COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS

General Information

Contracting Office Address Department of Veterans Affairs Network Contracting Activity (NCO) 8 Orlando VA Healthcare System (OVAHCS) 13800 Veterans Way Orlando, FL 32827

Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” in conjunction with FAR 13 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; Quotes are being requested, and a written solicitation document will not be issued. This combined synopsis/solicitation is issued as a Request for Quote (RFQ) 36C24819Q1045.

Submit written quotes in accordance with Addendum to FAR 52.212-1, Instruction to Offerors outlined in pages 30 of this solicitation. Oral quotes will not be accepted. This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC_2019-02; effective June 05, 2019. North American Industrial Classification Standard (NAICS) 334516, Analytical Laboratory Instrument Manufacturing, with a Size Standard of 1250 employees, applied to this procurement. The Department of Veterans Affairs, Orlando VA healthcare System located in Orlando, Florida 32827 intends to award a single firm fixed price contract for the purchase, set up, delivery and implementation of the Anatomic Pathology Specimen Tracking System. It will include appropriate workstations to track Anatomic Pathology (AP) samples from the point of collection at various locations through OVAHCS. Section of the Pathology and Laboratory Medicine Service.

This requirement is for Brand Name or Equal be sure to note the Brand Name and Part Number you are quoting and provide documentation (specifications) for end user evaluation. For authorized distributors of the Brand-Name, proof of authorized distributorship must be included in the submission to the Contracting Officer. The Contracting Officer will deem the submission an “uninterested party” if authorized distributorship paperwork from the Original Equipment Manufacturer (OEM) is not received or missing with your quoted submission.

Table of Contents

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:

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

b. GOVERNMENT: Patricia Brown, Contracting Officer, patriciaE.brown@va.gov Katy Werby, Contract Specialist, katy.werby@va.gov Network Contracting Office 8 (NCO 8) Orlando – Commodities Team 13800 Veterans Way Orlando, FL 32827

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

3. INVOICES/PAYMENT: Invoices shall be submitted electronically the following month services were performed in accordance with:

a. 852.232-72 Electronic Submission of Payment Requests (NOV 2018)

b. 30 Days after receipt and acceptance

c. Payments shall be made in arrears upon receipt of a properly prepared invoice.

d. In order to comply with the Improper Payment Elimination and Recovery Act of 2012 (IPERA), the VA has mandated electronic invoice submission to the Veterans Affairs Financial Services Center (VAFSC). VAFSC has partnered with Tungsten Corporation e-Invoicing network, for submissions of all electronic invoices to VA. Tungsten Network electronic invoicing is free to all VA vendors. In order to submit electronic invoices, all VA vendors must register with Tungsten Network by submitting an email to Tungsten Network VA.Registration@tungsten-network.com or calling 1-877-752-0900 option 2 for Enrollment.

e. VA’s Electronic Invoice (e-Invoice) system uses a third-party contractor (Tungsten Network) for submission of electronic invoices. Go to this website to begin submitting electronic invoices, free of charge: http://www.tungsten-network.com/customer-campaigns/veteransaffairs-us/

For assistance setting up e-Invoice, the below information is provided:

· Tungsten Network e-Invoice Registration: VA.Registration@tungsten-network.com

· Tungsten Network e-Invoice Setup Information: (877)752-0900 (Option 2 - Enrollment)

· Tungsten Network Customer Service: (877)489-6135

· OB10 Portal to submit electronic invoices: VA.Registration@ob10.com

· VAFSC – for Invoice receipt or payment questions, call: (877)353-9791 or

· VAFSC Email: vafsccshd@va.gov

FACSIMILE, E-MAIL, AND SCANNED DOCUMENTS ARE NOT ACCEPTABLE FORMS OF

SUBMISSION FOR PAYMENT REQUESTS

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

CONTRACT ADMINISTRATION

The Contracting Officer is the only person authorized to approve changes or modify any of the requirements under this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitment or issue changes that will affect price, quantity or quality of performance of this contract. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in cost incurred thereof.

B.2 STATEMENT OF WORK

ANATOMIC PATHOLOGY (AP) SAMPLE TRACKING SYSTEM

1.0 INTRODUCTION

This performance work statement describes the requirement for procuring, set up, delivery, and implementation of an Anatomic Pathology (AP) Sample Tracking System for the Orlando VA Medical Center (OVAMC). It will include appropriate workstations to track Anatomic Pathology samples from the point of collection at various locations throughout (OVAMC) clinics, the main hospital locations and the Anatomic Pathology (AP) Laboratory section of Pathology and Laboratory Medicine Service, 13800 Veterans Way, Orlando, FL 32827. It will include tracking of all work related to the cases through processing within the AP Laboratory and diagnostic reading of the sample cases by the pathologists to completion.

2.0 SCOPE OF WORK

2.1 OVERVIEW - This system will utilize a tracking system, which must be on the OI&T VA One Technical Reference Model (TRM) list of approved software so that barcode labels with patient and sample information shall be generated using Veterans Information Systems and Technology Architecture (VistA) at the point of collection of samples. Tracking of these samples using barcode scanning (through intermediary locations, if needed) to the AP Laboratory for processing shall be accomplished as well as the ability to identify samples that were not shipped to the AP Laboratory in a timely manner via a tracking log generated at the time of sample collection. Additionally, the samples shall be tracked through each processing station in the AP Laboratory to the pathologist utilizing various vendor equipment. Extra testing, as required by the pathologist, shall be communicated electronically to the AP Laboratory staff for completion. A variety of reports shall be generated as needed by AP Laboratory staff to assist in workflow.

This project shall consist of two phases. Phase One shall consist of receiving and implementation of the AP sample tracking system, with all required hardware, connectivity and licensing, in the Anatomic Pathology (AP) Laboratory section of Pathology and Laboratory Medicine Service at the OVAMC, including Histology, Cytology, Autopsy, Grossing stations and the Pathologists workstations. Phase Two of implementation shall encompass designated locations at the Orlando VA Medical Center to include Surgery, Medical Service Clinics, and Community-Based Outpatient Clinics (CBOC).

2.2.1.1 Phase One Implementation will include the following locations: AP Laboratory Rms. 2J711, 2J711A, 2J711B, 2J711D: Histology-Accessioning, Cytology, Grossing (2), Tissue Processing, Embedding (2), Microtomy Sectioning (5), Routine Stainer with Cover slipper, Special Stainer, and IHC stainer; Cytology-Thin Prep, and Manual stainer; Pathologists’ Offices (7) and Cytotechnologist offices (3).

2.2.1.2 Phase Two Implementation will include designated areas in Surgery, Endoscopy, and select Medical Center Clinic locations to be designated. Exact location of each site will be determined in conjunction with the P&LMS Laboratory Director, the AP Laboratory Supervisor and the COR after award of the procurement.

2.2.2 PRODUCTS / SALIENT CHARACTERISTCS

All products must meet all salient characteristics defined in this section. All hardware provided shall be new and the current version of a standard product of a manufacturer whose main occupation is the manufacture of such equipment. 24-hour repair or replacement for all hardware must be included for the duration of the warranty or service agreement. Contractor shall configure all hardware necessary to meet functional requirements. All servers and workstations needed to run the AP Sample tracking system will be included, and the servers that are provided must be physical, not virtual. As this procurement requires a LAN connection, any additional cabling is to be provided and pulled by the contractor at no additional cost to the government. Unlimited user access and unlimited installation of software on designated computers within the OVAMC system.

2.2.2.8 Implementation of Collection Site Systems

2.3 IMPLEMENTATION of ANATOMIC PATHOLOGY LABORATORY SYSTEMS

2.3.1 All engineering costs incurred in installation and implementation

2.3.2 Installation of software on designated computers not acquired through the vendor

2.3.3 Complete project management of installation and implementation will be provided with ongoing needs analysis

2.3.4 Verification of operation in coordination with the Chief Pathologist of PLMS or his designee, the AP Laboratory Supervisor and the COR

2.3.5 Functionality Configurations verified in coordination with the AP Laboratory Supervisor, the Chief Pathologist of PLMS or his designee.

2.3.6 Training materials for staff shall be developed and provided. Personalized user training through final implementation of the system.

2.3.7 Initial customized templates for use with the system to be developed in coordination with the Chief Pathologist of PLMS or his designee.

2.3.8 HL7 Connections shall be completed in coordination with the AP Laboratory Supervisor, the Clinical Engineering group and the Laboratory Information Manager

2.3.9 Initial Reports designs for use with the system to be developed in coordination with the AP Laboratory Supervisor, the Chief Pathologist of PLMS or his designee.

2.3.10 Maintenance of a synoptic, or standardized, checklist format compatible with the current College of American Pathologists (CAP) Cancer Protocols and Checklists.

2.4 AP SAMPLE TRACKING SYSTEM Informational License fee

2.4.1 This will be a one-time, non-recurring fee for the AP SAMPLE TRACKING SYSTEM software

2.4.2 This license will allow additional workstations to be connected in the future without additional licensing fees

2.5 SERVER with AP SAMPLE TRACKING SYSTEM Software installed

2.5.1 The specifications of the server are to be determined by the vendor

2.5.2 All AP SAMPLE TRACKING SYSTEM software necessary to complete the functionality of the AP SAMPLE TRACKING SYSTEM will be installed onto the server by the vendor according to their own requirements

2.5.3 The Anatomic Pathology Specimen Tracking System Software package must be able to share HL7 messages with the VA VistA Anatomic Pathology Computer System and the Thermo-Fisher Slide Mate and Printmate.

2.5.4 Must be able to track from Surgery/Clinic through intermediary (if needed) to the Laboratory.

2.5.5 Must allow Multisite Workstations

2.5.6 Must track identified quality parameters at each step

2.5.7 Must allow Scanning of requisitions and documents

2.5.8 Must allow use of Dragon Speak Voice recognition

2.5.9 Must have customizable reporting templates

2.5.10 Must have the capacity to include grossing, processing, embedding, sectioning, staining and pathologist’s workstations

2.5.11 Must have bar code label option for use with Hologic TP5000

2.5.12 Must provide cytology tracking including user workload and specimen statistics

2.5.13 Must have an open interface with IHC and special staining platforms

2.5.14 Must allow gross specimen digital image capture

2.5.15 Must have workflow displays

2.5.16 Must allow development of automatic protocols

2.5.17 Must have a transcription workstation

2.5.18 Must allow call flags and recuts functions

2.5.19 Must allow pathologists workload distribution data to be collected

2.5.20 Must have individual user security management

2.5.21 Must have editable lab dictionaries

2.5.22 Must allow case/specimen/cassette/slide verification

2.5.23 Must provide additional testing orders to be generated electronically

2.5.24 Must allow creation of staining worklists

2.5.25 A Backup server must be included as part of this package

2.5.26 Select Staff from the OVAMC Clinical Engineering group must have administrator access to servers

2.5.27 Training will be conducted for System Administrators

2.6 ANNUAL SUPPORT FOR ALL COLLECTION SITES

2.6.1 Provide 24/7 same day telephone and/or remote software

2.6.2 On-site support for critical issue/problem

2.6.3 Provide 24/7 same day telephone support for hardware acquired by the vendor

2.6.4 Replacement support within 24 hours for hardware covered under warranty at no additional cost

2.6.5 Applicable software upgrades included on at least a quarterly basis with documented validation of the upgraded software. Onsite validation included.

2.7 ANNUAL SUPPORT FOR THE ANATOMIC PATHOLOGY LABORATORY

2.7.1 24/7 same day telephone and/or remote software

2.7.2 On-site support for critical issue/problem

2.7.3 24/7 same day telephone support for hardware acquired by the vendor

2.7.4 Replacement support within 24 hours for hardware covered under warranty at no additional cost

2.7.5 Software upgrades included on at least a quarterly basis with documented validation of the upgraded software. Onsite validation included.

3.0 DELIVERY AND INSTALLATION

3.1. DELIVERY

3.1.1 Delivery of all items will be within 90 days of award. Set-up, installation and implementation shall be coordinated with the OVAMC COR or Anatomic Pathology Supervisor.

3.1.2 Contractor shall review all items needed for this project with the OVAMC COR or Anatomic Pathology Supervisor to ensure all items requested on the project are included and final placement is correct prior to installation.

3.1.3 Installation shall be scheduled per phase. Each phase shall be coordinated with COR or Supervisor.

3.2. INSTALLATION

3.2.1 Phase One shall include all areas within the Anatomic Pathology (AP) Laboratory section of Pathology and Laboratory Medicine Service at the Orlando VA Medical Center (OVAMC).

3.2.2 Phase Two shall include select, designated locations at the OVAMC and AP Supervisor or COR designated Medical / Surgical Services.

3.2.3 Installation and Implementation shall only be by the vendor’s qualified staff or their official representatives and shall comply with all necessary VA OI&T and Clinical Engineering regulations.

3.2.4 The contractor shall coordinate all deliveries, staging areas, installations, implementation, training and parking arrangements with the COR or AP Supervisor.

3.3 INSTALLATION SCHEDULE

3.3.1 Contractor shall develop an installation schedule, which shall include installation and inspection of the specified item as well as a final confirmation with the COR in coordination with the CO. The contactor shall provide the installation schedule within 15 business days of award for COR final approval.

3.3.2 The installation shall be completed in two phases. Phase One shall consist of all areas within Anatomic Pathology Laboratory. Phase Two shall consist of specified locations in Surgery, Endoscopy and select clinic locations to be determined by the AP Supervisor or COR.

3.3.3 Phase One Implementation and installation shall be completed within 3 months from beginning of implementation.

3.3.4 Phase Two Implementation and installation shall be completed within 3 months from beginning of implementation.

3.4 PERIOD OF PERFORMANCE AND WORKING HOURS

3.4.1 All work shall be completed between 8:00 a.m. and 4:30 p.m. Monday – Friday. All federal holidays, excluded.

3.5 INSPECTION AND ACCEPTANCE

3.5.1 The Contractor shall conduct a joint inspection with the COR at the end of each Phase. The COR shall inspect all phases of delivery, installation and implementation and provide a punch list of all incomplete or unsatisfactory items.

3.5.2 Contractor shall provide dates of completion of punch list items and replacement parts and/or short ship items from the manufacturer(s).

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

3.6 DELIVERY/STORAGE REQUIREMENTS

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

3.6.2 Package to prevent damage or deterioration during shipment, handling, storage and installation. Maintain protective covering in place and in good repair until removal is necessary.

3.6.3 Store products in dry condition inside enclosed facilities.

3.6.4 All delayed delivery arrangements, within 60 days, shall be at no additional cost to the Government.

4.0 DELIVERABLES

4.1 Operator’s manuals for all hardware included.

4.2 Operator’s manuals for the AP SAMPLE TRACKING SYSTEM

4.2 Training plans and materials for all aspects of the AP SAMPLE TRACKING SYSTEM

4.3 Progress reports on at least a monthly basis for each phase

5.0 OPERATOR TRAINING

5.1 Contractor shall provide On-site training of the AP SAMPLE TRACKING SYSTEM to the Users.

5.2 Scheduling of operator training shall be coordinated with the OVAMC COR.

6.0 FIELD VERIFICATION & COMPLETION WALK-THRU

6.1 Contractor must validate successful implementation throughout each phase and of the finished product overall.

7.0 PROTECTION OF PROPERTY

7.1 Contractor shall protect all items from damage. The Contractor shall take precaution against damage to the building(s), grounds and furnishings. The Contractor shall repair or replace any items related to building(s) or grounds damaged accidentally or on purpose due to actions by the Contractor.

7.2 The Contractor shall be responsible for security of the areas in which the work is being performed prior to completion.

8.0 SECURITY REQUIREMENTS

8.1 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.

8.2 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.

8.3 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 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 onsite inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

i. The contractor/subcontractor’s firewall and Web services security controls, if applicable, shall meet or exceed VA’s minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COR.

8.4 INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerability scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor’s security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA’s network involving VA information must be reviewed and approved by VA prior to implementation.

b. Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII.

c. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor’s systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office. Government-owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks.

d. The contractor/subcontractor’s system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA’s POA&M management process. The contractor/subcontractor must use VA’s POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and reauthorized per VA Handbook 6500.3. This may require reviewing and updating all the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary.

e. The contractor/subcontractor must conduct an annual self-assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost.

f. VA prohibits the installation and use of personally-owned or contractor/subcontractor-owned equipment or software on VA’s network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VA- approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE.

g. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract.

h. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes.

The options are:

(1) Vendor must accept the system without the drive;

(2) VA’s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or

(3) VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

(4) Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;

(a) The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and

(b) Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre- approved and described in the purchase order or contract.

(c) A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation.

8.5 SECURITY INCIDENT INVESTIGATION

a. The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

b. To the extent known by the contractor/subcontractor, the contractor/subcontractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

8.6 LIQUIDATED DAMAGES FOR DATA BREACH

a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

b. The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

c. Each risk analysis shall address all relevant information concerning the data breach, including the following:

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

(2) Description of the event, including:

(a) date of occurrence;

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

(3) Number of individuals affected or potentially affected;

(4) Names of individuals or groups affected or potentially affected;

(5) Ease of logical data access to the lost, stolen or improperly accessed data considering the degree of protection for the data, e.g., unencrypted, plain text;

(6) Amount of time the data has been out of VA control;

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

(8) Known misuses of data containing sensitive personal information, if any;

(9) Assessment of the potential harm to the affected individuals;

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

(11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.

d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $ _______ per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

(1) Notification;

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

(3) Data breach analysis;

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

(5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

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

8.7 SECURITY CONTROLS COMPLIANCE TESTING

On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-days’ notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time.

8.8 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 COR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until the training and documents are complete.

8.9 REFERENCE (S):

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

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

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

4. VHA Handbook 1605.5, Business Associate Agreements – 22 July 2014

5. Privacy Act of 1974 (5 U.S.C. 552a).

9.0 WARRANTY & REPAIRS

9.1 In the event the Contractor folds or sells the business, they have the responsibility to continue to service the existing contract until completion. In the event of sale, the purchasing company would honor their support agreements as part of the sale.

9.2 All specified product(s) shall be under at least standard commercial warranties.

9.3 Contractor must provide service and warranty for repairs as needed within 24 hours of required notice at no additional costs.

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

License Fee: AP Specimen Tracking System

Implementation of Specimen Tracking System

Hardware: Server w/ AP Sample Tracking System Software including backup software & backup storage installed.

Hardware: Lab Station Touchscreen PC - with Prosupport and NBD Limited onsite Service after remote diagnosis

Hardware: Grossing Station Touchscreen PC - with warranty

Hardware: AP Tracking System Specimen label Printer - with warranty service agreement priority.

Hardware: AP Tracking System Barcode Scanner - with service agreement.

Hardware: AP Tracking System Barcode Reader - with service agreement

Hardware: AP Tracking System Grossing HD Camera - with accidental damage replacement plan.

Hardware: NiceLabel Print License - 10 devices

Hardware: AP Specimen Tracking System Desk Mount Arm

Support Service: AP Specimen Tracking System - Base year up to 6 months included @ no charge

Annual Service Agreement: AP Specimen Tracking System Includes System Updates, Post Configurations, HL 7 Connection Support, Remote Support, SQL/Client Support,Critical On-site Support Contract Period: Option 1 POP Begin: 10-01-2019 POP End: 09-30-2020

Annual Service Agreement: AP Specimen Tracking System Includes System Updates, Post Configurations, HL 7 Connection Support, Remote Support, SQL/Client Support,Critical On-site Support Contract Period: Option 2 POP Begin: 10-01-2020 POP End: 09-30-2021

Annual Service Agreement: AP Specimen Tracking System Includes System Updates, Post Configurations, HL 7 Connection Support, Remote Support, SQL/Client Support,Critical On-site Support Contract Period: Option 3 POP Begin: 10-01-2021 POP End: 09-30-2022

Annual Service Agreement: AP Specimen Tracking System Includes System Updates, Post Configurations, HL 7 Connection Support, Remote Support, SQL/Client Support,Critical On-site Support Contract Period: Option 4 POP Begin: 09-30-2022 POP End: 10-01-2023

B.4 DELIVERY SCHEDULE

13800 Veterans Way Orlando, FL 32827

USA

(407) 631-2622 Esther.Murphy@va.gov

13800 Veterans Way Orlando, FL 32827

USA

13800 Veterans Way Orlando, FL 32827

USA

13800 Veterans Way Orlando, FL 32827

USA