Attachment B - Middleware SOW v2.docx

SECTION A

SOLICITATION/CONTRACT FORM CONTINUED

1. IDIQ Administration: All IDIQ administration matters shall be handled by the following individuals:

1. OFFEROR:

1. OFFEROR REMITTANCE ADDRESS: All payments by the Government to the Offeror will be made in accordance with:

[X] 52.232-34, Payment by Electronic Funds Transfer - Other than Central Offeror Registration, or

[ ] 52.232-36, Payment by Third Party

1. INVOICES: Invoices shall be submitted in arrears:

1. GOVERNMENT INVOICE ADDRESS: All invoices from the Offeror shall be submitted electronically to: www.fsc.va.gov/einvoice.asp.

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

The above amendment section must be filled-out in the event that an Amendment(s) is sent to the offeror or posted to https://beta.sam.gov/ and must be returned with the RFQ package. Failure to acknowledge amendment(s) may constitute the rejection of the offer.

SECTION B

1. DESCRIPTION AND REQUIREMENTS OF THE CONTRACT

1.1 This is an Indefinite Delivery Indefinite Quantity Contract (IDIQ) pursuant to Federal Acquisition Regulation (FAR) part 13 and 16, for the Department of Veterans Affairs (VA), Veterans Integrated Service Network (VISN) 22. This IDIQ is for a middleware solution for all types of Point of Care (POC) testing within VISN 22. This IDIQ shall provide a system that can transmit patient test results into the hospital’s current laboratory information system for items under Attachment A. Contractor agrees to the following terms of the IDIQ exclusively with the VISN facilities listed in 1.6. However, as requirements change, facilities within VISN 22 may be added or deleted by supplemental agreement between the Government and the Contractor.

1.2 This IDIQ does not obligate any funds. The Government is obligated only to the extent of authorized delivery/task orders (DO/TO) issued under the IDIQ by contracting officers (CO) for VISN 22 and the minimums established under section 1.3 which will be obligated via authorized DO/TO’s. All products ordered under DO/TO’s shall be subject to the terms and conditions of this IDIQ.

1.3 VISN 22 has provided estimated requirements in Attachment A. Additional items may be added to this IDIQ that are related to the use of POC middleware requirements. All attachments identified in Section C are hereby incorporated into this document as a part of the document itself, however this document shall supersede any conflicts of terms and conditions present in Section C attachments that may arise.

1.3.1 Minimum value of IDIQ: $1,000.00

1.3.2 Maximum ceiling value of IDIQ: $10,000,000.00

1.4 The IDIQ base period shall be for a period of five years with three one-year options. Within the duration of this IDIQ, each facility may place orders within the ordering base and exercised options period of the IDIQ.

1.4.1 Base Period: (TBD upon award, target date of 1/1/2021 – 12/31/2025)

1.4.2 Overall with Options: (TBD upon award, target date of 1/1/2021 – 12/31/2028)

1.5 Delivery Orders issued shall be identified by IDIQ Number (To Be Determined upon award).

1.6 Participating Facilities: (Additional Facilities within VISN 22 may be added to this contract with an exercise of a supplemental agreement between the CO and Contractor. A Contracting Officer Representative (Hereafter referenced as COR) shall be assigned as a primary point of contact. Line items within the schedule reflect the overall estimated volume of all sites below and take into consideration the potential addition of future facilities within VISN 22.

1.6.1 VA Greater Los Angeles Healthcare System | 11301 Wilshire Blvd, Los Angeles, CA 90073

1.6.2 VA Loma Linda Healthcare System | 11201 Benton Street Loma Linda, CA 92357

1.6.3 VA San Diego Healthcare System | 3350 La Jolla Village Dr, San Diego, CA 92161

1.6.4 VA Long Beach Healthcare System | 5901 E. 7th Street, Long Beach, CA 90822

1.6.5 VA Phoenix Healthcare System | 650 E Indian School Rd, Phoenix, AZ 85012

1.6.6 VA Prescott Healthcare System | 500 North Hwy 89, Prescott, AZ 86313

1.6.7 VA Tucson Healthcare System | 3601 S 6th Ave, Tucson, AZ 85723

1.6.8 VA Albuquerque Healthcare System | 1501 San Pedro Dr SE, Albuquerque, NM 87108

2. SCHEDULE OF SUPPLIES AND SERVICES

2.1 Attachment A: This section shall comprise the IDIQ Schedule. Delivery Orders may be placed/obligated with line items identified within the IDIQ Schedule. All line items not specifically listed within Attachment A may still be provided under this IDIQ from the Contractor’s catalog at the following set discounted % of or shall provide a catalog with identified discounts on all items within the catalog. On an annual basis, contractor shall provide an updated catalog of available items (An online catalog is acceptable).

(NOTE: SECTION 2 IS BEST ARTICULATED WITH ATTACHMENT “A” READILY ACCESSIBLE)

2.2 Tab 1 of Attachment A “Schedule of Pricing”:

2.2.1 All contract line items that may be used within a DO/TO.

2.2.2 Upon award, additional items may be added to this section via supplemental agreement between Contractor and the Government.

2.2.3 Tab 1 shall provide information concerning Nomenclature, Product/Service Number, Unit of Issue, Unit Price and additional comments.

2.3 Tab 2 of Attachment A “Implementation”:

2.3.1 This tab provides the estimated VISN need for the initial delivery orders of the IDIQ to implement this system.

2.4 Tabs 3 – 5 of Attachment A (Facility Information):

2.4.1 Tab 3 “Summary by Facility” – Provides information of what types of point of care systems are utilized within each facility.

2.4.2 Tab 4 “Summary by Product Type” – Provides additional information regarding what point of care system manufacturers are in place throughout the VISN.

2.4.3 Tab 5 “Required Licenses” – Identifies the name and number of instruments/meters that require middleware coverage in each facility.

2.4.3.1 Column F – Represents information from the contractor that describes what line items with quantities on Tab 1 will correlate to the item identified in column B.

2.4.3.2 Column G – Represents additional information provided by the contractor.

3. STATEMENT OF WORK

3.1 Introduction to Required Specifications

3.1.1 Contractor shall provide a middleware solution for point of care (POC) testing connectivity that can transmit patient test results into the hospital’s current laboratory information system for requirements identified in Attachment A. This middleware hardware and software solution (including servers if necessary) will allow the end user to monitor patient and quality control testing done via POC and help the laboratory meet numerous accreditation requirements for POC testing. It will allow Pathology and Laboratory Medicine Service (P&LMS) to accomplish its objective of backing up, storing and transmitting essential data from POC equipment into the patient electronic health record. This supports the mission of the VA to provide timely, accurate and appropriate laboratory services in support of patient care by allowing data transmission from instrumentation into the patient laboratory information database. This is essential for reduction of clerical errors and delayed test result availability to clinicians that could compromise patient safety.

3.1.2 This software should be specific for instrumentation and processes used for laboratory POC testing. The middleware solution will be used to post patient results to the permanent record from POC test sites at each facility’s main campus and associated community-based clinics. The solution ensures a continuity of services and will be acquired for a base five (5) year period as well as all service and maintenance services. Virtual servers are required and must be capable of using Windows Server 2016/2019 and be capable of handling security updates in addition to all current security requirements as specified in Attachment C - VA Directive 6550.

3.1.3 Each delivery order shall be subject to the terms and conditions of this IDIQ. Provided items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals, Contracting Officer Representative’s (Hereafter referenced as COR), and the VISN program office. These individuals shall be identified upon award of the IDIQ.

3.1.4 Equipment: All equipment shall be new, state of the art, and not recertified nor refurbished. Equipment shall be acquired for each of the stations located at the following VISN 22 facilities: See section 1.6 and Attachment A.

3.1.5 Industry Standards: Unless otherwise stated, all equipment shall be held to current industry standards for such equipment as present within the current market for Middleware equipment, supplies and related services.

3.2 Middleware Requirements

3.2.1 System shall interface, provide data handling and management for the following POC devices: See Attachment A.

3.2.2 System will allow connection to solicited or unsolicited fully configurable interface. Terminal host should be able to be transitioned if needed.

3.2.3 In addition to the instruments and quantities listed in Attachment A, system will have the ability to interface and accommodate alternate POC devices and an increased number of current devices in the event that POC testing increases or a change is made with POC instruments, for the duration of the IDIQ. System should be able to interface at minimum of 100 mb/s.

3.2.4 System shall allow for a single program point of contact for point of care administrators. The point of care administrator will be able to manage the instruments connected as well as all of the point of care users from one program.

3.2.5 The middleware system must be capable of generating reports such as, but not limited to, reagent lot number specific statistics (mean, standard deviation, coefficient of variation) with Levey Jennings graphs, linearity graphs, Quality Control (QC) outlier results, patient outlier critical test results, i-STAT Quality Check Codes by location and operator, proficiency testing results, and reagent usage and expiration.

3.2.6 System should be able to add additional testing locations within each facility at no additional cost.

3.2.7 System should provide secure email functionality within its software.

3.2.8 The system must allow for manual entry of non-instrument test results to include documentation of information for each test entry such as reagent lot numbers, expiration dates and internal quality control results in the middleware system. The system will support entry of non-instrument results by operators directly into the middleware and from POC instruments with the capacity and feature of manual test entry.

3.2.9 Supports active Directory Integration.

3.2.10 Supports i-STAT Advance quality control features.

3.2.11 Must be able to provide historical quality control and patient test result data without loss of reagent lot specific information.

3.2.12 Middleware must provide a means of managing quality control including patient testing lock out for failed quality control or quality control not performed at the programmed frequency and be able to display, in Levey-Jennings charts, all results of quality control in use.

3.2.13 Must allow customer to remotely configure from one program any instrument settings options furnished within the point of care instrument by the manufacturer

3.2.14 Must support successful implementation and a non-manual method of uploading historical data, i.e. operators and meters/analyzers in the transition from different system.

3.3 Connectivity and Conformance Standards

3.3.1 The middleware system must be compliant with all Office of Information and Technology and Information Security directives.

3.3.2 The hardware must meet all VA minimum specifications and the software version must be approved for use on the VA network (Windows 10 and Server 2016/2019).

3.3.3 Must be capable of connecting to an HL7 interface and must comply with the VHA Lab POC HL7 Interface Specifications Document.

3.3.3.1 https://www.va.gov/vdl/application.asp?appid=149

3.3.4 The contractor’s performance must be in compliance with all applicable state, federal and local laws and regulations.

3.3.5 The middleware product supplied by the contractor must appear as an approved technology on the most current VA Technical Reference Model (TRM) or must be within 2 lifecycles of the most recent TRM approved version.

3.3.5.1 https://www.oit.va.gov/Services/TRM/TRMHomePage.aspx.

3.3.6 Must support solicited and unsolicited interface for the i-STAT. Contractor must have a MOU/ISA.

3.3.6.1 https://vaww.portal2.va.gov/sites/infosecurity/FY15CRISPAudit/CRISPRemediationContract/WorkSite/SitePages/MOU-ISA_Version2.aspx

3.4 Support Features

3.4.1 Service Maintenance / Warranty

3.4.1.1 The contractor provides 24 hour, 7 days a week Technical Support by calling a toll-free number.

3.4.1.2 Any reference range, reporting units, abnormal value flags or critical value flag updates will be at no cost to the medical center.

3.4.1.3 The Contractor provides documentation of services performed.

3.4.1.4 Emergency Repair - Technical Support is available Monday through Friday, 8:00 A.M. to 5:00 P.M., MST. After business hours including weekends and holidays, an answering service is available. Responses will be received from technical support within 30 minutes via phone call.

3.4.1.5 The Contractor shall provide a warranty for all items and services provided under the IDIQ for the duration of the IDIQ and all associated delivery orders

3.4.2 Additional Features and Requirements

3.4.2.1 Training, instruction, and consultation must be provided by the contractor for both initial installation and post installation operations.

3.4.2.2 Contractor shall at minimum provide on-site training for up to 8 hours per site as requested by the facility.

3.4.2.3 Contractor will provide example policies and procedures such as standard operating procedure templates.

3.4.2.4 The Contractor shall provide a training program that is coordinated with and timely to the equipment installation. Training shall include initial setup and user training; onsite training for go-live support, super user training and follow-up training

3.4.2.5 The system will provide the customer a means of managing operator identification information, ongoing training and competency assessment dates, with analyzer lockout when not complete or equivalent solution.

3.4.2.6 User and Service Manuals: The Contractor shall provide downloadable PDF versions of operator manuals, service manuals, electronic schematics, troubleshooting guides, diagnostic software and tools Additionally, any upgrades to these documents shall be provided by the Contractor free of charge. These manuals shall include all components and subsystems, including those not manufactured by the Contractor. These manuals and documentation shall be identical to the ones supplied to the manufacturer’s service representatives and shall contain the diagnostic codes, commands, and passwords utilized in maintenance, repair and calibration of the equipment/software and provided for the life of the system at no additional cost.

3.4.3 Upgrade/Updates: The Contractor shall provide updates to both the equipment hardware and software in order to maintain the integrity of the system and the state-of –the art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to “system updates” that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, update offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the IDIQ; however, it does refer to significant changes in the hardware operational capability. Should the VISN decide to upgrade their current equipment ie. - replacement of existing equipment with newer models, the CO and Contractor may do so under a signed supplemental agreement.

4. PACKAGING & MARKING

4.1 Packaging

4.1.1 All equipment and supplies shall be adequately packaged to prevent damage during shipping, handling and storage. Bags or packages shall be whole, intact, and not otherwise torn or damaged. Upon delivery, the Government shall examine all packages. The Contractor shall be required to replace unacceptable or damaged products at the Contractor’s expense.

4.2 Marking

4.2.1 All items shall be marked clearly with the IDIQ Number, Delivery Order Number, Obligation number and delivery location within the hospital ie. Emergency Room. For major Equipment, the Obligation number shall begin with an A after the station number ie. 600A20000. All other service items shall be marked with a C number ie. 600C20001. The Delivery Order number shall have a format similar to this example:36C26221N0001.

5. DELIVERIES & PERFORMANCE

5.1 Installation/Implementation

5.1.1 Implementation/transition timeframe: All sites shall have complete installation and go live of their system within one year of award of this IDIQ.

5.1.2 Contractor shall execute an implementation plan which includes:

· Installation - Contractor shall make every effort to conduct a concurrent implementation at all sites with weekly collaborative meeting. Contractor shall provide a dedicated project manager throughout the entire implementation. Installation shall also include conversion of all current data minimally including operator profiles.

· Testing- Shall include at minimum a test of all analytes in addition through all testing phases (pre- analytical, analytical, and post-analytical). In addition, training must be provided to all sites.

· Acceptance-Must meet the approval requirements of accrediting agencies and laboratory medical director approval at each facility to meet accreditation standards.

· Go-Live- Dedicated project management and technical support must be available above the requirements of Section 3.4.1 the day of go-live at each site for 3 days.

· Post Go-Live Follow Up- Check-in should include at least a two week and 30 day after go-live date.

5.1.3 Installation/Site Preparation:

5.1.3.1 Site preparation specifications shall be furnished in writing by the Contractor as a Site Preparation Report after award of the delivery/task order. The Contractor shall provide coordinated professional installation and implementation project management services to implement the system specified in the SOW at all identified sites. The Contractor shall provide a firm estimate of working days required from date of delivery order to go-live based upon the SOW. The initial installation site report shall be provided to the CO no later than one week after the initial post award conference and all other site reports shall be provided at least forty-five (45) days before installation of all those sites. Contractor shall visit each site and propose the location of equipment and determine specific site prep requirements including but not limited to:

· Space availability

· Power availability

· Equipment shall be new, state of the art, and not recertified or refurbished

· Configuration of mounts, modules, and peripheral equipment.

· VA responsibilities

· Provide additional power requirements as provided in vendor specifications

5.2 Delivery: The Contractor shall deliver all supplies and services identified in the schedule to the locations identified in section 1.6.

5.2.1 The delivery location is subject to change as required by the designated authority or authorized personnel at the receiving facility. The Contracting Officer Representative (Hereafter referenced as COR) shall be required to notify the Contractor when delivery locations have been changed.

5.2.2 All deliveries shall be made during normal working hours from 8:00 a.m. to 4:00 p.m. and a copy of the packing list/slip shall be provided at time of delivery. The packages packing list/slip shall contain the complete purchase order number, IDIQ number, shipping address, delivery location, items/quantity ordered and items/quantity shipped. Standard orders shall be delivered within no more than 30 working days after receipt or placement of order.

5.3 Service / Maintenance – See section 3.4

6. CONTRACT ADMINISTRATION DATA

6.1 Ordering, Invoice and Payment

6.1.1 The Contractor shall list in the spaces below the name(s) and address(es) of customer service departments with whom the Government facilities shall place orders:

Name:

Address:

Phone No:

Fax No:

Contact:

Email:

Name:

Address:

Phone No:

Fax No:

Contact:

Email:

6.1.2 Payment Address: The Contractor shall submit in arrears a completed individual itemized invoice in accordance with the address below.

VA Finance Center PO Box 149971 Austin, TX 78714

6.1.3 Invoice Information: The following information shall be listed on all invoices (Failure to comply may result in refusal of an invoice resulting in delayed payment at the fault of the Contractor).

6.1.3.1 Facility’s Name and address where service was provided

6.1.3.2 IDIQ Number (For Example: 36C26221A0001)

6.1.3.3 Delivery Order Number (For Example: 36C26221N0001)

6.1.3.4 Obligation Number (For Example: VA600-C27001)

6.1.3.5 A Line Item break down of usage for example:

6.1.3.6 Line item 1 GI Scope Lease: 1 MO at $400.00

6.1.3.7 Line item 4 GI Service Maintenance: 1 MO at $10.00

6.1.3.8 Include the period of time that is being invoiced for in the invoice.

6.1.3.9 IDIQ Holder’s Internal Contract number (if applicable)

6.1.3.10 Include point of contact for concerns and questions. Contractor must name a specific person, phone number and email.

6.2 IDIQ Program Manager

6.2.1 The Contractor shall provide a IDIQ program manager who shall be responsible for the performance of the work under the IDIQ. In addition, the program manager shall act as the main focal point of communication between the Contracting Officer and the Contractor. The name of this person shall be designated in writing to the Contracting Officer. The program manager shall have full authority to act on behalf of the Contractor on all contractual/IDIQ matters relating to daily operation of the IDIQ.

6.3 Hours of work

6.3.1 The IDIQ shall include a minimum five (5) days a week, nine (9) hours a day full-service agreement to include all necessary service calls. Contractor shall also provide technical support via phone seven (7) days a week, twenty-four (24) hours a day. After hours and weekends in person service are chargeable as per line items within Attachment A.

6.3.2 Any service performed during other than normal work hours must be approved in advance by the facility COR or CO.

6.3.3 Holidays: Only emergency service shall be provided on National Holidays and only if authorized by the COR in advance as approved in the delegation of authority. The rates shall be chargeable as per Attachment A.

6.3.4 When a National Holiday falls on a Sunday, the following Monday shall be observed as a National Holiday. When a National Holiday falls on a Saturday, the proceeding Friday is observed as a National Holiday by U.S. Government agencies. Also included, would be any other day, specifically declared by the President of the United States of America to be a National Holiday.

7. SPECIAL IDIQ REQUIREMENTS

7.1 Physical Security and Facility Considerations

7.1.1 Identification, Parking, Smoking and VA Regulations (For any onsite services):

7.1.1.1 The Contractor employees and/or Subcontractors approved by the COR shall wear visible identification at all times while on the premises of the facilities within the VISN. Identification shall include but not be limited to a company identification card, which shall include the company name, employee name, title, and a photograph of the employee. Contractor Employees shall maintain a professional appearance commensurate to their industry.

7.1.1.2 It is the responsibility of the Contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police Section. The VA will not invalidate or make reimbursement for parking violations of the Contractor under any conditions.

7.1.1.3 Any interior or exterior doors that shall be unlocked to gain access shall be kept locked during the performance of work unless it results in the creation of a safety hazard. In those instances, the Contractor is responsible to take necessary actions to maintain the same level of security prior to gaining access/performing work. Should any other devices need to be unlocked like an entry gate, those devices shall be locked immediately upon entry or exit. At no time shall the Contractor allow any person into a locked area or loan keys/access cards to another person. Contractor may be held in default for failure to comply with this requirement and subject the Contractor and its employees to contractual and other legal remedies.

7.1.1.4 Contractor personnel are required to check into the facility Police & Security office at each visit to pick up a “contractor” badge prior to contacting the COR. The Contractor’s staff shall also be required to sign in and out each day at a designated location determined by the COR.

7.1.1.5 The Contractor agrees that none of its officers or employees shall use or reveal any research, statistical, medical, or security information which may be obtained during the performance of the work or as a result their presence on Government premises without the written consent of the Government

7.1.1.6 Smoking is prohibited inside any buildings at facilities within VISN 22.

7.1.1.7 Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.

7.1.1.8 The Contractor shall not allow his/her employees, including Subcontractors’ employees, to open desk drawers, cabinets, or to use office equipment, including the use of non-pay telephones for any purpose other than a local emergency call. The Contractor shall be responsible to provide all necessary equipment, tools, parts, and materials to perform the work. The Government shall not be obligated to provide any equipment, tools, parts, and materials to assist the Contractor in performing the work.

7.1.2 Background Checks:

7.1.2.1 The Office of Security and Law Enforcement provides Department-wide policy on the assignment of appropriate position sensitivity designations associated with Department of Veterans Affairs (VA) positions involving national security and public trust responsibilities, and on the level of background investigations required for applicants for, and incumbents of, those positions.

7.1.2.2 IAW VA 0710 Handbook, appointees and contract personnel appointed to Low/Moderate/High Risk positions must be subjects of a background investigation conducted by OPM and receive a favorable adjudication from the VA Office of Security and Law Enforcement to ensure compliance with such policy. If such investigation has not been completed prior to contract commencement, the Contractor shall be responsible for the actions of those individuals performing under the contract.

7.1.2.3 Should the contract require Contractor’s personnel to maintain U.S. citizenship, the Contractor shall be responsible for compliance. Regardless of U.S. citizenship requirements, Contractor’s personnel are required to read, write, speak, and understand the English language, unless otherwise specified in this contract or agreed to by the Government.

7.1.2.4 The cost for such investigations shall be borne by the Contractor, either in advance or as reimbursement to the Government. The level of sensitivity shall be determined by the Government on the basis of the type of access required. The level of sensitivity will determine the depth of the investigation and the cost thereof. At this time, the current estimated costs for such investigations are as follows:

LEVEL OF

SENSITIVITY

BACKGROUND

INVESTIGATION LEVEL

APPROXIMATE COST

7.1.2.5 The Contractor shall be required to furnish all applicable employee information required to conduct the investigation, such as, but not limited to, the name, address, and social security number of the Contractor’s personnel. The VA will provide all the necessary instructions and guidance for submission of the documents required to conduct the background investigation. Background investigations shall not be required for contract personnel assigned to Low Risk/Non-sensitive positions for 180 days or less under a single contract or series of contracts. However, a Security Access Clearance (SAC) background screening will be required for appropriate preliminary checks IAW VA Directive 0710.

7.2 Information Technology Security Considerations

7.2.1 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.

7.2.2 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.

7.2.3 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:

7.2.4 Vendor must accept the system without the drive;

7.2.5 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

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

7.2.7 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;

7.2.8 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

7.2.9 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.

7.2.10 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.

7.2.11 In addition, please see Attachment D - VA Handbook 6500.6 Appendix C for additional Information Technology terms and conditions.

7.3 Insurance Requirements for work performed on Facility Grounds

7.3.1 The Contractor agrees to procure and maintain, while the Contract is in effect, Workers Compensation and Employee’s Public Liability Insurance in accordance with Federal and State of California and/or Nevada laws.

7.3.2 The Government shall be held harmless against any or all loss, cost, damage, claim expense or liability whatsoever, because of accident or injury to persons or property of others occurring in the performance of this Contract.

7.3.3 The Contractor shall be responsible for all damage to property, which may be done by him, or any employee engaged in the performance of this Contract.

7.3.4 Before commencing work under this Contract, the Contracting Officer shall require the Contractor to furnish certification from his/her insurance company indicating that the coverage specified by FAR 52.228-5 and per FAR 28.307-2 has been obtained and that it may not be changed or canceled without guaranteed thirty (30) day notice to the Contracting Officer.

7.3.5 Contractor is required to provide copies of proof of Workers Compensation and Employee Public Liability Insurance within fifteen (15) calendar days after notification of Contract award.

SECTION C

1. ATTACHMENTS AND SUPPORTING DOCUMENTATION

1.1 Attachment A – Schedule

1.2 Attachment B – Middleware SOW (This document)

1.3 Attachment C – VA Directive 6550

1.4 Attachment D – VA Handbook 6500.6 Appendix C

1.5 Attachment E – Past Performance References