36C25620Q0347-001.pdf

36C25620Q0347

COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS

General Information

Document Type: Combined Solicitation/Synopsis Solicitation Number: 36C25620Q0347 Posted Date: March 20, 2020 Questions Due Date/Time: March 27, 2020 / 10:00am (CST) Response Due Date/Time: April 3, 2020 / 10:00am (CST) Product or Service Code: J065 (Maintenance/Repair/Rebuild of Equipment-

Medical, Dental, and Veterinary Equipment and Supplies)

Set Aside: NONE (UNRESTRICTED) NAICS Code: 811219 (Other Electronic and Precision Equipment

Repair and Maintenance) Size Standard: $22.0 million Point of Contact: John Walker - Email: John.Walker15@va.gov

Contracting Office Address

Department of Veterans Affairs Network Contracting Office 16 Michael E. DeBakey VA Medical Center (MEDVAMC) 2002 Holcombe Blvd, Bldg. 100 Houston, TX 77030

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,” as supplemented with additional information included in this notice.

This announcement constitutes the only solicitation; quotations are being requested, and a written solicitation document will not be issued.

This solicitation is a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2020-04 (effective 01/15/2020).

To be eligible for award, contractor must be actively registered in the System for Award Management (SAM) at the time of award. If you are a SDVOSB or VOSB, in order to receive credit as a SDVOSB or VOSB, you must be verifiable in the Vendor Information Pages (VIP) https://www.vip.vetbiz.gov at the time of award. Quotes may be considered non-compliant and rejected if the Contracting Officer is unable to verify active registration status.

The MEDVAMC is seeking a contractor to provide Beckman Coulter Flow Cytometry Preventative Maintenance and Repair Services in accordance with the below Statement of Work (SOW). All interested companies shall provide quotations for the following:

mailto:John.Walker15@va.gov https://www.vip.vetbiz.gov/

1. SCOPE

1.1 The Contractor shall furnish all labor, materials, parts, equipment, tools, transportation/travel, factory-trained/licensed/authorized personnel, certifications, management, and supervision required to perform annual Preventative Maintenance (PM) and repair service on Beckman Coulter Flow Cytometry equipment listed in paragraph 1.2 below, in accordance with this Scope of Work (SOW).

1.2. Equipment List:

Model Serial # Maximo AEMS/MERS ID Navios 10 AW27313 580 EE172293 Navios 10 AW41339 580 EE172756 PrepPlus 2 1408000978 Same as TQ-Prep; Shares processor with TQ-Prep TQ-Prep AW28056 580 EE165717

1.3. Place of Performance:

Michael E. DeBakey VA Medical Center (MEDVAMC) Building 100 2002 Holcombe Boulevard Houston, TX 77030

1.4. Period of Performance: The government estimates awarding a Base Year plus 2 (two) Option Year periods (at the government’s discretion) estimated as follows:

• Base Year: April 15, 2020 – April 14, 2021

• Option Year 1: April 15, 2021 – April 14, 2022

• Option Year 2: April 15, 2022 – April 14, 2023

2 OPERATIONAL COVERAGE:

2.1. Normal hours of operation are Monday through Friday, from 8:00am to 6:00pm (excluding

Federal Holidays). All service/repairs shall be performed during normal hours of operation, unless requested and approved by the COR or CO.

2.2. The Government also observes Executive Orders, President’s Proclamation, and days designated by Federal Statute. The following are Federal Holidays observed by the Government are: New Year’s Day, Martin Luther King’s Birthday, President’s Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veteran’s Day, Thanksgiving and Christmas; along with any other day specifically declared by the President of the United States to be a national holiday.

2.3. If the holiday falls on a Sunday, the following Monday will be observed as a National holiday. When a holiday falls on a Saturday, the preceding Friday is observed as a National holiday by U.S. Government Agencies, and any other day specifically declared by the President of the United States.

3 DEFINITIONS/ACRONYMS:

• Biomedical Engineer(ing) - Supervisor or designee

• CO – Contracting Officer

• COR – Contracting Officer’s Representative

• PMI – Preventative Maintenance Inspection: Services which are periodic in nature and are required to maintain the equipment in such condition that it may be operated in accordance with its intended design and functional capacity with minimal incidence of malfunction or inoperative conditions.

• FSE – Field Service Engineer: A person who is authorized by the contractor to perform maintenance (corrective and/or preventive) services on the MEDVAMC premises.

• ESR – Vendor Engineering Service Report: Documentation of the services rendered for each incidence of work performance under the contractual terms and conditions

• Acceptance Signature: Government POC/COR who is authorized to sign-off on the ESR which indicates that the PM has been concluded or is still pending completion, or that the Emergency Repair has been accomplished or is still in a pending status.

• Authorization Signature: COR's signature (indicates COR accepts work status as stated in

ESR)

• NFPA – National Fire Protection Association

• CDRH – Center for Devices and Radiological Health

• OEM – Original Equipment Manufacturer

4 GENERAL REQUIREMENTS:

4.1. The Contractor shall provide calibration and preventive maintenance inspections in accordance with the manufacturer’s latest specifications.

Calibration procedures shall consist of the following:

• Calibrating the entire instrument to traceable calibration standards

• The instrument shall be cleaned completely

• Worn or defective parts shall be replaced as necessary (per manufacturer’s specs)

Preventive Maintenance Inspections:

• Shall be scheduled at least 3 (three) days in advance in coordination with the COR

• Shall include all necessary intervening service calls required to replace any worn or defective parts needed due to instrument failure

4.2. Equipment Coverage: The Contractor shall ensure equipment identified in paragraph 1.2 has the following coverage:

• On-site labor, travel and parts during normal business hours

• On-site service support

• Technical phone support – 24 Hours per day

• Unlimited Emergency services during contract period and normal business hours

• Annual scheduled PM to factory specifications

• Serviced by Authorized and factory trained/certified OEM technicians only

• Instrument engineering modifications according to OEM factory specifications

• Utilizes only genuine OEM replacement parts

• Excludes UV lamp replacement parts

4.3. Parts: The Contractor shall furnish and replace parts to meet SOW requirements. The Contractor shall provide new or factory reconditioned OEM parts and components when providing maintenance and repair services as described herein. The Contractor shall have ready access to all parts, including unique and/or high mortality replacement parts. All replacement units, parts, components, and materials to be used in the maintenance, repair, and alteration of equipment shall be compatible with that of existing equipment on which it is to be used; shall be of equal or better quality than original equipment specifications; shall conform to the technical specifications and used in accordance with original design and manufacturer intent. The contract shall include all parts [except -if applicable - those parts specifically listed as being EXCLUDED]. Rebuilt parts, used parts or those removed from other equipment, shall not be installed without specific approval by the CO or the COR. (The Contractor shall also list any excluded parts under the service contract).

Gray Market Prevention:

(1) Gray market items are Original Equipment Manufacturers (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for a services contract for maintenance of medical equipment (i.e. replacement parts) for the MEDVAMC. No remanufactures or gray market items will be acceptable.

(2) Vendor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed service contract for maintenance of medical equipment (i.e. replacement parts), verified by an authorization letter or other documents from the OEM, such that the OEM’s warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the medical supplies, medical equipment and/or services contracts for maintenance of medical equipment shall be in accordance with the OEM terms and conditions.

(3) The delivery of gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract. Accordingly, the VA reserves the right to enforce any of its contractual remedies. This includes termination of the contract or, solely at the VA’s election, allowing the Vendor to replace, at no cost to the Government, any remanufactured or gray market item(s) delivered to a VA medical facility upon discover of such items.

5 UNSCHEDULED MAINTENANCE (Emergency Repair Service):

5.1. The Contractor shall maintain the equipment in accordance with the OEM’s latest specifications. The Contractor shall provide repair service which may consist of calibration, cleaning, oiling, adjusting, replacing parts, and maintaining the equipment, including all intervening calls necessary between regular services and calibrations. Only the CO or COR has the authority to approve/request a service call from the Contractor.

5.2. Response Time: The Contractor's Field Service Engineer (FSE) shall respond with a phone call to the COR within two (2) hours after receipt of telephoned notification (during normal business hours). Should the two (2) hour response time span any time after normal business hours, the time before the end of regular business hours shall be counted and resumed at the beginning of the next period of regular business hours. If the problem cannot be corrected by phone, the FSE shall commence work (on-site physical response) within forty-eight (48) hours after receipt of this second notification; and shall proceed progressively to completion without undue delay. This requirement for response time shall be for services calls during the VA normal business hours. Corrective work shall be completed within 48 hours from telephone contact time, unless the time is extended by the COR or CO.

5.3. The Contractor shall provide mandatory safety and performance-related updates to covered equipment and software. Additionally, the contractor must have the ability to concurrently address multiple emergency calls and unscheduled maintenance on different equipment.

5.4. Any charges for parts, services, labor, travel, manuals, tools, or software required to successfully complete unscheduled maintenance is included within this contract per the Equipment Coverage section, and its agreed upon price, unless specifically stated in writing otherwise and approved by the COR or CO.

6 SCHEDULED MAINTENANCE:

6.1. The Contractor shall perform PM service to ensure that equipment identified in paragraph 1.2 performs in accordance with Section 7, Conformance Standards. PMIs shall be scheduled at least 3 (three) days in advance with the COR or CO. The PM must be accomplished in accordance with the latest OEM maintenance procedures and protocols (An outline of the PM procedures and schedule shall be provided to the COR). The Contractor shall provide an utilize procedures and checklists with worksheet originals indicating work performed and actual values obtained (as applicable). This documentation shall be provided to the COR at the completion of the PM. The contractor shall provide written description of PMIs. This description shall include an itemized list of the procedures performed, including electrical safety. PM services shall include, but need not be limited to, the following:

• Cleaning of equipment.

• Reviewing operating system software diagnostics to ensure that the system is operating in accordance with Section 7, Conformance Standards or OEM specifications.

• Calibrating and lubricating the equipment.

• Performing remedial maintenance of non-emergent nature.

• Testing and replacing faulty and worn parts and/or parts likely to become faulty, fail or become worn.

• Inspecting/replacing where indicated, electrical wiring and cables for wear and fraying.

• Inspecting, and replacing where indicated, all mechanical components which may include, but is not limited to: cables and mounting hardware, chains, belts, bearings and tracks, interlocks, clutches, motors, and keyboards for mechanical integrity, safety, and performance.

• Returning the equipment to the operating condition defined in Section 7, Conformance Standards, and in accordance with the OEM.

• Providing documentation of services performed.

• Inspecting and calibrating the hard copy image device.

6.2. PM services shall be performed in accordance with, and during the hours defined in, Section 2, Operational Coverage, and the PM schedule established herein. All exceptions to the PM schedule shall be arranged and approved in advance with the COR.

6.3. Any charges for parts, services, labor, travel, manuals, tools, or software required to successfully complete scheduled maintenance is included within this contract per the Equipment Coverage section, and its agreed upon price, unless specifically stated in writing otherwise and approved by the COR or CO

7 CONFORMANCE STANDARDS:

7.1. The Contractor shall ensure all equipment functions in conformance with OEM specifications used when the equipment was originally procured; to include any upgrades/updates, as well as following the latest published standards/specifications/regulations, in addition to the specifications identified in the manufacturer’s latest published manuals and guidelines as identified below:

7.1.1. Manufacturer’s specifications, Association for the Advancement of Medical

Instrumentation (AAMI), Joint Commission for the Accreditation of Healthcare Organizations (JCAHO), National Fire Protection Agency 99 (NFPA-99), Center for Device and Radiological Health (CDRH), Original Equipment Manufacturer (OEM), American Hospital Association (AHA), Institute of Electrical And Electronic Engineers (IEEE), Underwriters Laboratories (UL), Occupational Safety and Health

Administration (OSHA), College of American Pathologists (CAP), VAMC standard operating procedures, and any other Federal, State, and Local regulations pertaining to the equipment listed for this contract.

7.2. The Contractor shall perform all work to the satisfaction of the COR. The COR shall inspect the repairman’s work and indicate approval on a signed statement prior to departure.

8. SERVICE MANUALS/TOOLS/EQUIPMENT/TRAVEL: The MEDVAMC shall not provide travel, tools, (test) equipment, service manuals or service diagnostic software to the contractor.

The contractor shall obtain, have on file, and make available to its FSE's all travel, operational and technical documentation (such as; operational and service manuals, schematics, and parts list) which are necessary to meet the performance requirements of this contract. The location and listing of the service data manuals, by name and/or the manuals themselves shall be provided to the CO upon request.

9. DOCUMENTATION/REPORTS: The documentation shall include detailed descriptions of the scheduled and unscheduled maintenance (i.e., Emergency repairs) procedures performed, including replaced parts and prices (for outside normal working hour services) required to maintain the equipment in accordance with Section 7, Conformance Standards or the manufacturer's specifications. Such documentation shall meet the guidelines as set forth in the Conformance Standards section. The Engineering Service Report (ESR) shall consist of a separate PM report for the item(s) covered under the "specific" contract. Grouping different equipment from different contracts on "one" ESR is prohibited. In addition, each ESR shall, at a minimum, document the following data legibly and in complete detail:

• Name of contractor and contract number.

• Name of FSE who performed services.

• Contractor service ESR number/log number.

• Date, time (starting and ending), equipment downtime and hours on-site for service call.

• VA purchase order numbers covering the call if outside normal working hours.

• Description of problem reported by COR.

Identification of equipment to be serviced:

• Inventory ID number

• Manufacturer's name

• Device name

• Model number

• Serial number

• Any other manufacturer's identification numbers.

Itemized Description of Service Performed (including, if applicable, Costs associated with after normal working hour services) including:

• Labor and Travel

• Parts (with part numbers)

• Materials and Circuit Location of problem/corrective action.

Total Cost to be billed (if applicable - i.e., part(s) not covered, or service rendered after normal hours of coverage).

Signatures:

• FSE performing services described.

• Authorized VA Employee who witnessed service described.

NOTE: - Any additional charges claimed must be approved by the COR before service is completed!

10. REPORTING REQUIREMENTS:

10.1. The Contractor shall report to Biomedical Engineering to log in. This check in is mandatory.

When the service is completed, the FSE shall document services rendered on a legible ESR(s).

The FSE shall be required to log out with Biomedical Engineering and submit the ESR(s) to the COR. ALL ESRs shall be submitted to the equipment user for an "acceptance signature" and to the COR for an "authorization signature". If the COR is unavailable, a signed, authorized copy of the ESR will be sent to the Contractor after the work can be reviewed (if requested or noted on the ESR).

10.2. Points of Contact: Devang Patel and Rikesha George

• Location (Building/Room Number): BA-200

• Telephone Number & Extension(s): 713-794-7271/7270

• Contractor - Provide telephone number(s) to call for your Service Department:

• Provide name(s) of authorized contact person(s):

10.3. Service Report: The Contractor’s repairman shall complete a full-service report, in writing, after each service call (emergency or scheduled) and submit either a hardcopy or an electronic version of said report to the COR within 5 (five) days after the service is performed.

11. CONTRACTOR RESPONSIBILITIES: The Contractor shall:

• Be liable to the Government for any damage done to Government property caused by themselves or their employees.

• Upon contract award, provide valid and reliable contact information for service, preventative maintenance, emergency and technical assistance requests.

• Immediately, but no later than 24 consecutive hours after discovery, notify the CO and COR

(in writing) of the existence or the development of any defects in, or repairs required, to the scheduled equipment which the Contractor considers he/she is not responsible for under the terms of the contract. The Contractor shall furnish the CO and COR with a written estimate of the cost to make necessary repairs.

• Ensure all equipment covered in this contract be in optimum working condition at the contract expiration date provided that the Contractor is notified of any deficiencies at least one (1) day before the contract expiration date.

• At no extra charge, provide any engineering and software updates necessary for continued optimum operation of the equipment listed in this contract.

12. CONTRACTOR QUALIFICATIONS/REQUIREMENTS:

• Each respondent must have an established business, with an office and full-time staff. The staff includes a "fully qualified" FSE and a "fully qualified" FSE who will serve as the backup.

• "Fully Qualified" is based upon training and on experience in the field. For training, the

FSE(s) has successfully completed a formalized training program, for the equipment and is OEM Certified. For field experience, the FSE(s) has a minimum of two (2) years of experience (except for equipment newly on the market) with respect to scheduled and unscheduled preventive and remedial maintenance, on Beckman Coulter equipment.

• The FSEs shall be authorized by the OEM to perform the maintenance services. All work shall be performed by "Fully Qualified", OEM Certified competent FSEs. The Contractor shall submit with technical quote, proof/evidence of valid certification/license as a Beckman Coulter trained technician. Failure to submit proof/evidence of valid certification/license as a Beckman Coulter trained technician shall result in a non-compliant technical quote. The COR or CO may authenticate the training requirements, request training certificates or credentials from the Contractor at any time for any personnel who are servicing or installing any MEDVAMC equipment. The CO and/or COR specifically reserve the right to reject any of the Contractor's personnel and refuse them permission to work on the equipment if evidence is not provided when requested.

• Subcontractor(s), if utilized, must be approved by the CO. The Contractor shall submit any proposed change in subcontractor(s) to the CO for approval/disapproval.

13. CONDITION OF EQUIPMENT: The Contractor accepts responsibility for the equipment in "as is" condition. Failure to inspect the equipment prior to contract award will not relieve the Contractor from performance of the requirements of this contract. The Contractor shall show to the COR that the required system components are in place and fully functional prior to acceptance by the COR.

14. REMOVAL OF EQUIPMENT: Should a piece of equipment require repair at the Contractor’s facility, the Contractor shall coordinate with the COR prior to removal of the of equipment. The Contractor shall obtain a signed Property Pass from the Acquisition & Material Management Service, Personal Property Section, 4A-320; only after removal is authorized by the COR. The Contractor may not remove equipment from Government site for minor repairs only. The Contractor shall be responsible for damage or loss of equipment while in the Contractor ‘s charge.

15. TEST EQUIPMENT: Prior to commencement of work on this contract, the Contractor shall provide the COR with a copy of the current calibration certification of all test equipment which is to be used by the Contractor on MEDVAMC equipment. This certification shall also be provided on a periodic basis when requested by the COR. Test equipment calibration shall be traceable to a national standard.

16. SAFETY REQUIREMENTS:

16.1. In the performance of this contract, the Contractor shall take such safety precautions as the CO or COR may determine to be reasonably necessary to protect the lives and health of occupants of the building. The Contractor shall have one supervisory employee, who will disseminate requirements to those who work at our facility, report to the Safety Manager’s office for a one-time training class before working on-site. The CO or COR shall notify the Contractor of any noncompliance with the foregoing provisions and the action to be taken. The Contractor shall, after receipt of such notice, immediately correct the conditions to which attention has been directed. Such notice, when served on the Contractor or his representative at the worksite shall be deemed sufficient for the purpose aforesaid. If the Contractor fails or refuses to comply promptly with such notice, the CO may issue an order stopping all or any part of the work and hold the Contractor in default.

16.2. The VAMC, CO, COR or any of its and/or their associates, employees under any conditions or circumstances shall not be held responsible for any safety incident or any injury or any inconvenience experienced by the Contractor, their associates, or subcontractors while performing the services, labor, travel, software upgrades or maintenance included within this contract to the extent applicable by federal, local and state law with federal law taking precedence.

17. INSURANCE: The Contractor shall be responsible for:

• Worker compensation and employer's liability: The Contractor shall comply with applicable Federal and State Worker Compensation and occupational disease statutes.

• General Liability: The Contractor shall have Bodily Injury Liability Insurance coverage written on the comprehensive form of policy of at least $500,000 per occurrence.

• Property Damage Liability: The Contractor shall have Property Damage Liability insurance coverage of at least $500,000.

18. PRIVACY/SECURITY:

• The Contractor shall not have electronic connectivity to the VA network. The contractor will only have access to patient databases and PHI when physically troubleshooting image quality and other specific imaging related maintenance needed to access VA systems to perform software upgrades, preventative maintenance and maintenance repairs.

• Any electronic or magnetic data storage devices such as hard drives, etc. shall be turned into the ISO. Electronic or magnetic data storage devices are not to be removed from VA property.

• The Contractor shall identify if removable media (i.e. USB or DVD/CD Device) is required to perform his/her duties. Personally owned USB thumb drive utilization is prohibited. Non-VA support personnel must furnish their own FIPS140-2 certified USB thumb drives, and only with the permission of a designated VA supervisor. All USB drives must be scanned with an antivirus program running current virus definitions by the local VA staff, prior to connection to any VA device. COR or designee will ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device system.

The computer system for scanning removable media is located in the Biomedical Engineering shop, Building 100, Room BA200.

19. ADDITIONAL REQUIREMENTS:

• The contractor shall obtain all necessary licenses and/or permits required to perform this work.

Contractor shall take all precautions necessary to protect persons and property from damage during performance of this contract. Contractor shall be responsible for any injury to himself or his employees, or others, as well as for any damage to personal property that occurs during the performance of this contract that is caused by him/her or his/her employee’s fault or negligence

• All employees and subcontractors shall wear a visible name and company identification when onsite. When more than one person is onsite performing work under this contract, one must be designated as a supervisor and must be fully responsible for the work to be performed.

• Employees and subcontractors working onsite must wear the VA Contractor badge. The COR shall be responsible for securing contractor badges for each contracted employee.

• The Contractor shall provide all supplies, materials, equipment, qualified personnel, supervision, management, and transportation to perform all tasks as identified herein. All work is to be performed in accordance with the guidelines established by Federal, State, and local ordinances and The Joint Commission. The Contractor’s procedures and quality control procedures shall conform to these guidelines.

• Contractor personnel shall conduct their work so as not to interfere with the normal functioning of the facility and will stop work if asked by medical center personnel. Hours of work may need to be limited to daytime on units where patients sleep and night time in areas where patients would be exposed to risk by daytime work.

• The Contractor shall take all precautions necessary to protect the lives and health of occupants of the building.

• The Contractor shall follow procedures required by Infection Control personnel and the construction safety committee, to include any required dust control.

• The Contractor shall immediately correct any fire and safety deficiencies caused by his personnel.

If the contractor fails or refuses to correct deficiencies promptly, the CO may issue an order stopping all or any part of the work and may hold the contractor in default of the contract.

• The Contractor shall comply with applicable Federal, State, and local safety and fire regulations and codes which are in effect at the beginning of the contract period. The contractor shall keep abreast of any changes in these regulations and codes applicable to the contract.

• All material and equipment shall be removed from the facility or stored properly at the end of each work day and secured during the work day in the areas specified by the COR.

• No hot electrical work shall be performed. Any electrical work that is necessary shall be coordinated with the COR, and lockout/tagout provisions must be presented if electrical work is required.

• The Contractor shall require his employees to comply with all VA rules and regulations pertaining to the conduct of his employees while on station. Particular attention is drawn to the fact that the VAMC is a NO SMOKING Facility. Smoking is not permitted in any building and is only permitted in designated smoking shelters on the VA campus.

• Contractor shall have use of station telephones to make business calls related to Medical Center’s equipment. Misuse of this privilege will necessitate the need to require the contractor to use public telephones.

• 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.

20. CONTRACT ADMINISTRATION:

20.1. Changes to Contract or SOW: The CO is the only individual authorized to approve changes or modify any of the requirements under this SOW or impending contract. The Contractor shall communicate with the COR on all matters pertaining to contract administration. The COR is designated to represent the CO in furnishing technical guidance and advice regarding the work being performed under this contract. Only the CO is authorized to make commitments or issue changes affecting price, quantity or performance of this contract. Costs incurred by the Contractor through the actions of parties other than the CO shall be borne by the Contractor.

20.2. Payments: The Contractor shall submit requests for payment electronically to the VA’s Tungsten Network. Invoices shall be paid Quarterly, in arrears for all authorized work performed, upon receipt of a properly prepared invoice submitted to:

https://www.fs.va.gov/einvoice.asp

Invoices shall include, at a minimum, the following information:

• Name and address of the contractor

• Invoice date and number

• Contract Number, Purchase Order Number, contract line item number

• Detailed description of quantity, unit of measure, unit price and extended price of the services performed

• Item(s) covered (to include serial #'s) by the PMI and covered period of service.

21 VA Directive 6500.6 - Contract Security (Appendix C)

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.

21.1. 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.

https://www.fs.va.gov/einvoice.asp

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.

21.2. VA INFORMATION CUSTODIAL LANGUAGE

a) Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

b) VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct on-site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c) Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook

6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

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

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

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

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

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

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

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

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

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

21.3. SECURITY INCIDENT INVESTIGATION

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

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

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

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

21.4. LIQUIDATED DAMAGES FOR DATA BREACH

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

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

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

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

(2) Description of the event, including:

(a) date of occurrence;

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

(3) Number of individuals affected or potentially affected;

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

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

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

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

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

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

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

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

d) Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

(1) Notification;

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

(2) 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.

21.5. 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.]

a) 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.

b) 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.

(End of Statement of Work)

SECTION A

A.1 APPLICABLE PROVISIONS AND CLAUSES

The provision at 52.212-1 Instructions to Offerors – Commercial Items (Oct 2018), applies to this acquisition.

The provision at 52.212-2 Evaluation – Commercial Items (Oct 2014) applies to this acquisition.

All offers shall include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications –Commercial Items (Dec 2019).

• Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, “Offerors Representations and Certifications-Commercial Items”. If paragraph (j) of the provision is applicable, a written submission is required.

The clause at 52.212-4, Contract Terms and Conditions – Commercial Items (Oct 2018), applies to this acquisition and a statement. The addendum to FAR 52.212-4 also applies to this acquisition.

The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items (Jan 2020), applies to this acquisition and all additional FAR clauses cited in the clause are applicable to the acquisition.

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

All quoters shall submit the following:

• Completed B.2 Price/Cost Schedule

• Signed Amendments (if any)

• Completed Attachment 1: Quality Assurance Surveillance Plan (QASP)

• Authorization letter from Beckman Coulter to perform maintenance services

• Evidence of Certification/License as a Beckman Coulter trained technician

This is an open-market Combined Synopsis/Solicitation (CSS) for services as defined herein. The government intends to award a contract as a result of this CSS that will include the terms and conditions set forth herein. To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows:

• "The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."

OR

• "The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"

Quoter shall list exception(s) and rationale for the exception(s).

https://www.sam.gov/portal

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: Name: ______________________________ Address:…