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Contract Opportunity

Performance Work Statement (PWS)

Preventive Maintenance and Repair on
Medtronic Puritan Bennett 980 Ventilators
Department of Veterans Affairs (VA)
Veterans Health Administration (VHA)
PURPOSE:
Veterans Affairs requires a contractor to provide preventative maintenance, repair, and parts on Medtronic Puritan Bennett 980 Ventilators at the Oklahoma City VA Health Care System. Services are to be performed in accordance with this PWS and to OEM standards, with the intent of ensuring the equipment operates as the original manufacturer intended, uninterrupted (95% uptime), in a cost-effective, efficient manner, contributing to the VA Mission.

Services are required on the government-owned systems listed in this PWS for the period of performance and at the location outlined in this PWS.

This Contract will be a non-personal services contract. The Contractor, its employees, agents and subcontractors shall not be considered government employees for any purpose. Contractor shall furnish all labor, materials, parts, equipment, tools, transportation, and supervision to provide services in accordance with this Performance Work Statement (PWS).

C&A requirements do not apply and a Security Accreditation Package is not required.

BACKGROUND:
Equipment: The following systems of equipment require service under this contract. This includes sub-systems, components, software, hardware, and parts.

Equipment
Description
Brand & Model
Original Equipment Manufacturer (OEM)
Serial Number
VA
PMI Number
Ventilator: Intensive Care
Puritan Bennett 980 Ventilators
Medtronic
35B1500320
59915
Ventilator: Intensive Care
Puritan Bennett 980 Ventilators
Medtronic
35B1500343
59916
Ventilator: Intensive Care
Puritan Bennett 980 Ventilators
Medtronic
35B1500267
59917
Ventilator: Intensive Care
Puritan Bennett 980 Ventilators
Medtronic
35B1500155
59918
Ventilator: Intensive Care
Puritan Bennett 980 Ventilators
Medtronic
35B1500269
59919
Ventilator: Intensive Care
Puritan Bennett 980 Ventilators
Medtronic
35B1500268
59920
Ventilator: Intensive Care
Puritan Bennett 980 Ventilators
Medtronic
35B1500335
59921
Ventilator: Intensive Care
Puritan Bennett 980 Ventilators
Medtronic
35B1500329
59922
Ventilator: Intensive Care
Puritan Bennett 980 Ventilators
Medtronic
35B1500199
59923
Ventilator: Intensive Care
Puritan Bennett 980 Ventilators
Medtronic
35B1500253
59924
Ventilator: Intensive Care
Puritan Bennett 980 Ventilators
Medtronic
35B1800076
67840
Ventilator: Intensive Care
Puritan Bennett 980 Ventilators
Medtronic
35B1800069
67841
Ventilator: Intensive Care
Puritan Bennett 980 Ventilators
Medtronic
35B1800622
67842
Ventilator: Intensive Care
Puritan Bennett 980 Ventilators
Medtronic
35B1703442
67843
Ventilator: Intensive Care
Puritan Bennett 980 Ventilators
Medtronic
35B1800044
67844
Ventilator: Intensive Care
Puritan Bennett 980 Ventilators
Medtronic
35B1800049
67845
Ventilator: Intensive Care
Puritan Bennett 980 Ventilators
Medtronic
35B1703435
67846
Ventilator: Intensive Care
Puritan Bennett 980 Ventilators
Medtronic
35B1800011
67847
Ventilator: Intensive Care
Puritan Bennett 980 Ventilators
Medtronic
35B1800058
67848
Ventilator: Intensive Care
Puritan Bennett 980 Ventilators
Medtronic
35B1800052
67849
Ventilator: Intensive Care
Puritan Bennett 980 Ventilators
Medtronic
35B2000771
72470
Ventilator: Intensive Care
Puritan Bennett 980 Ventilators
Medtronic
35B2003019
73693
Ventilator: Intensive Care
Puritan Bennett 980 Ventilators
Medtronic
35B2003024
73694
Ventilator: Intensive Care
Puritan Bennett 980 Ventilators
Medtronic
35B2004893
74297
Ventilator: Intensive Care
Puritan Bennett 980 Ventilators
Medtronic
35B2004894
74298
Ventilator: Intensive Care
Puritan Bennett 980 Ventilators
Medtronic
35B2006174
75340
Ventilator: Intensive Care
Puritan Bennett 980 Ventilators
Medtronic
35B2006210
75341
Ventilator: Intensive Care
Puritan Bennett 980 Ventilators
Medtronic
35B2007187
75342
Ventilator: Intensive Care
Puritan Bennett 980 Ventilators
Medtronic
35B2007198
75343
Ventilator: Intensive Care
Puritan Bennett 980 Ventilators
Medtronic
35B2007194
75344
Ventilator: Intensive Care
Puritan Bennett 980 Ventilators
Medtronic
35B2007188
75345

SUMMARY OF REQUIREMENTS:
Contractor shall provide OEM-trained technicians to perform OEM-standard services on equipment in this PWS. Services on the equipment include maintenance support, corrective maintenance repair, 24x7 emergency phone support, provision of parts (comprehensive parts coverage), and service and modification as required due to safety or reliability. All OEM software updates shall be included.

Tasks and Requirements:
Performance and Repairs: All work performed shall be in accordance with manufacturer s specifications, including but not limited to adjustments, calibrating, cleaning, lubricating, testing, disassembly, checkout, replacement of parts, etc. required to keep the equipment in operating condition. Contractor must guarantee 95% up time for the equipment. Contractor shall guarantee that all equipment covered by this contract shall be in optimum working condition at the completion of each contracted Period of Performance. Contractor will make every attempt to maintain and repair equipment on-site within a reasonable time, unless local environment prohibits on-site attendance. Failing this, contractor will provide substitute equipment in the event a repair continues beyond the reasonable time frame.

A reasonable time frame ensures the VA mission continues uninterrupted with no loss, damage or suffering to VA patients and resources.

Preventive Maintenance: Contractor shall provide periodic preventive maintenance service on equipment within the interval(s) set by the OEM (ie, Annual, Semi-Annual, Quarterly), in scheduled month of each contracted Period of Performance, including all work between Standard Business Hours, weekend hours, and non-standard hours, and arranged through the COR. The contractor shall work with the COR, Surgery service and Sterile Processing Service to not disrupt patient care by scheduling PM visits in advance. The visits will include equipment verification by an OEM-trained technician. Before the expiration of each period of performance, the contractor shall provide the COR with a report certifying the equipment listed in this PWS has been calibrated to O.E.M. standards not less than OEM recommended interval(s) during the contract period. All parts shall be O.E.M. standard or certified.

Service Call: Unscheduled service should be conducted at no additional cost during standard business hours, Monday through Friday, 8:00 AM 5:00 PM. Non-emergency service (machine still able to run with no increased patient risk) should be available, with a technician onsite at location, within 48 hours notice from the COR. If support call for repair service is deemed mission-critical, contractor will be on-site performing corrective action response to service calls within 24 hours of notice from COR, barring special circumstances. 24 hour service call center support should be available to schedule corrective service calls.
Technical phone support shall be available weekdays from 7:00 AM 7:00 PM at no additional charge.

Software Updates: Contractor shall provide any software updates, as they become available, for all equipment, at no additional cost. All software changes made become the property of the VA.

Help Desk Support: Contractor shall provide emergency telephone support during Standard Business Hours, as a minimum at no additional charge, with phone calls returned no later than 2 hours after a voice message has been left by the COR.

Modifications: If contractor or external hazard assessment/notification by the FDA, NCPS, or CEOSH determines that a modification is necessary to address safety concerns or reliability, installation and modification will be performed at no additional charge.

Parts: As part of the OEM-standard of service required on this contract, contractor must provide unique and/or high mortality replacement parts. All parts will be O.E.M. recommended parts. Contractor must provide repair services on batteries and handpieces, at no additional cost to the government. This includes provision of replacement/loaner parts and shipment costs, such as loaner handpieces. To maintain continuity of patient care, contractor must ship replacement/loaner handpieces overnight to the VA within 48 hours of receipt of notice by the VA that a hand piece needs to be repaired due to normal wear and tear. Once the loaner is received by the VA, the VA will ship the government-owned hand piece to the contractor.

If the government-owned hand piece is not able to be repaired the contractor must return the broken handpiece to the VA with written notification of what prevented the repair and the issues causing the part not to function the way the OEM intended.

If any contractor personnel performing service on site at the VA brings parts, devices, or equipment that have serial numbers and will be used in patient care, these items must be checked in upon entry and checked out upon exiting the VA with both Logistics and Biomed departments.

Shipment: Contractor shall be responsible for shipment of repair parts and substitute equipment at no expense to the government, with FOB destination terms applicable in these circumstances, and in favor of the VA Medical Center at this location. All shipments, labels, invoices and correspondence related to this contract must include the contract number and marked Attn: COR/Local VA POC [insert individual name] . Contractor must email the local VA POC or COR with carrier and tracking information in advance of all shipment of parts and equipment so the VA may be prepared to receive the items and track them to avoid loss.

GOVERNMENT FURNISHED EQUIPMENT / PROPERTY (GFE / GFP)
Government Property is any real property at the VAMC accessed by the Contractor in the performance of services in accordance with the PWS.

Condition of Equipment
The Contractor shall accept responsibility for the equipment in "as is" condition. Failure to inspect the equipment prior to contract award shall not relieve the Contractor from performance of the requirements of this contract.

Storage
Storage for Contractor equipment is not provided at the VAMC. The Contractor is responsible for the security of its equipment. The Government is not responsible for the security of Contractor equipment.

CONTRACTOR FURNISHED EQUIPMENT / PROPERTY (CFE / CFP)
Service Manuals/Tools/Equipment
The VAMC shall not provide 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 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.
QUALITY
Conformance Standards
Contractor shall ensure that their services, staff and equipment used in the performance of this contract conform and comply with the latest industry service standards, information, guidance, regulations and publications of the following:
AAMI-ANSI ST-79:2010 Part 7.7 standards (Servicing and Repairs of Devices in the Health Care Facility). This can be obtained at http://www.aami.org/publications/standards/st79.html
IAHCSMM - International Association of Healthcare Central Service Materiel Management
US FDA US Food and Drug Administration
CDC Centers for Disease Control and Prevention
CDRH Center for Devices and Radiological Health
ISO (As a minimum: ISO 9001:2008 Certification and ISO 13485:2003 certification (medical devices))
ASQ American Society for Quality
UL Underwriters Laboratories
OSHA Occupational Safety and Health Administration

Safety
The Contractor must perform services in accordance with:
local, state and federal Occupational Safety and Health guidelines and legislation, to include Occupational Safety and Health Administration (OSHA), the American National Standards Institute (ANSI) safety guidelines, and any VA Medical Center Directives;
local, state and federal Fire and Safety legislation and guidelines, to include VA Medical Center directives and legislation on Fire and Safety;
all other Conformance Standards identified in this PWS

Medical Center Policies
Each VA Medical Center has policies that are updated from time to time. The COR can provide more detailed information to the contractor of these upon commencement of the contract and throughout the term of the contract, as needed, especially policies regarding, parking, possession of weapons, cell phone use and photography as well as smoking on VA property. Violations of such policies may result in individual fines or citation answerable in the United States (Federal) District Court.

Remedy or Rework
Rework or Remedy is defined as performing the Service again until the Purpose of this PWS is achieved in full. This involves less than Satisfactory Service by the Contractor and as noted by the COR.

Rework or Remedy must occur within 3 business days of the notice of the rework or remedy requirement from the COR and at no additional cost to the Government.

Inspection and Acceptance of Services: The Government reserves the right to inspect and test services in accordance with this PWS and the Contract. The only individual authorized to officially accept services is the COR. While inspection of services may be delegated by the COR and a shared responsibility with departmental management staff, the COR is ultimately the only authorized individual to approve and accept services on behalf of the VA.

DELIVERABLES (refer also to Technical Qualification and Contact Points for additional Deliverables)
Service Report (SR)
Contractor is responsible for providing Service Reports for every service. A Service Report is required for all:
outgoing serviced equipment with an inventory of all equipment collected by the contractor,
and
incoming serviced equipment with an inventory of all equipment completely serviced and delivered by the contractor and with the Service Report provided to the COR at the time of delivery of serviced equipment.

Such documentation shall meet the guidelines as set forth in the Conformance Standards.

In addition, each Service Report shall, at a minimum, document the following data legibly and in complete detail:
Name of contractor and contract number.
Name of Field Technician who performed services.
Contractor s Service Report number/log number.
Date and time (arrival and departure) of Field Technician on-site at VA collecting and delivering equipment
VA purchase order number
Description of problem reported by COR.
Details of Equipment serviced:
Equipment set numbers
Device name, instrument type
Serial number
Any other manufacturer's identification numbers.
PMR and Service description
Total Itemized Cost of all parts and/or services provided
Signatures:
Field Technician performing services described.
COR acceptance signature

Invoices: The contractor must include the Service Report number on the associated invoice.

Service Reports (Engineers Service Report (ESR) or Service Report)
When the service is completed, the Field Technician shall document services rendered on a legible Service Report(s). During Check In/Check Out procedures with the COR, the Field Technician must provide the COR with the Service Report(s) for that service visit. ESR can be submitted electronically to the COR, not exceeding 5mb in size, following service completion yet before the Technician departs the location to ensure the COR has an opportunity to review and provide an acceptance signature. All Service Reports shall be submitted to the COR for an "acceptance signature". If the COR is unavailable, a signed copy of the Service Report shall be sent to the Contractor after the work can be reviewed (if requested or noted on the Service Report).

The Contractor shall immediately, but no later than 24 (twenty-four) consecutive hours after discovery, notify the COR (in writing) of the existence or the development of any defects in the equipment submitted for service which the Contractor considers he/she is not responsible for under the terms of the contract and where replacement is recommended.

TECHNICAL QUALIFICATIONS and PERSONNEL STANDARDS

Calibration of Vendor s Equipment: Contractor must provide the COR with certification attesting that all gauging and measurement equipment used to check and calibrate the subject items of equipment has been calibrated either according to the manufacturer s specifications or within the last twelve months against a standard that is traceable to the National Bureau of Standards.

Contractor must provide the COR and Contracting Office with such documentation, as a minimum:
Within 5 business days of contract award,
Within 5 business days after renewal or extension of services in accordance with, and if permitted by applicable FAR clause, and
in advance of commencing services on equipment identified in this PWS.

Qualifications of Contractor OEM-Trained Technicians: Contractor shall document, in writing, their experience in working on the identical make and model equipment listed in this PWS as well as the qualifications of individuals who will work on the equipment. Where the PWS requires OEM-trained technicians, demonstration of this will also be required in the documentation.

Contractor must provide the COR and Contracting Office with such documentation, as a minimum:
Within 5 business days of contract award,
Within 5 business days after renewal or extension of services in accordance with, and if permitted by applicable FAR clause, and
immediately, when previously assigned OEM-trained technicians have been replaced,
and in advance of commencing services on equipment identified in this PWS.

The contractor shall have sufficient staff to satisfactorily support this contract, including the PWS and its purpose. Contractor staff providing services on this contract must include a "fully qualified" Filed Service Engineer (FSE) and a "fully qualified" FSE who shall 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. For field experience, the FSE(s) has a minimum of two years of experience (except for equipment newly on the market) with respect to scheduled and unscheduled preventive and remedial maintenance of the equipment in this contract
The FSEs shall be authorized by the Contractor to perform the maintenance services. All work shall be performed by "Fully Qualified" competent FSEs. The Contractor shall provide written assurance of the competency of their personnel and a list of credentials of approved FSEs for each make and model the Contractor services at the VAMC. The 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 VAMC 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 VAMC equipment.
If subcontractor(s) are used, they shall be approved by the CO prior to commencement of services. The Contractor shall submit any proposed change in subcontractor(s) to the CO for approval/disapproval.
Contractor Employee s On-site At Location: At all times during performance of Services, in accordance with this PWS, the Contractor must ensure Contractor personnel:
Be able to function professionally amongst the general public in a hospital and health care environment. Where possible, a warm-natured and humane approach is preferred.
Be able to read, understand and apply printed rules, detailed orders, and instructions
Be familiar with and compliant with this PWS and Contractual requirements.
Be displaying VA Identification badges and Contractor-issued name tags, clearly visible to the general public
Be directly and personally escorted by the Contractor s on-site Supervisor when Contractor personnel are not displaying VA Identification badges and Contractor-issued name tags
Maintain a neat, clean, professional appearance
Be properly attired in Contractor-issued uniforms which clearly display Contractor branding, keeping in accordance with VHA Dress Policies.
Compliant with VA Safety and OSHA regulations throughout the VA Medical Center, as well as VA Medical Center policies.
Compliant with parking requirements at the VAMC and park only in the designated parking areas as assigned by the COR.
Maintain Decorum at all times. During the performance of services care and consideration must be given to VA visitors and staff. All Services must be performed with minimal disturbance or hindrance to VA Medical Center visitors and staff, specifically maintaining the requirements identified in the Overview of this PWS.

Contractor shall not be considered government employees for any purpose.

SECURITY PROCEDURES AND OPERATING HOURS
Check In/Out Procedures
Prior to commencement of services, and when visiting the VA Medical Center, the Contractor or Contractor s authorized Field Technician, must check in and out with the Biomed Administrative Officer located in the basement at the VA location, Room BE-100. Only individual VA Biomedical management staff, as delegated by the COR, can coordinate check in and check out procedures for the Contractor in the absence of the COR. Due to heightened security requirements, the Contractor or their authorized service representative will be required to wear an ID Badge which will be signed for upon arrival and turned in when leaving. All Badges must be worn at or above the waist and facing forward. This Badge must be turned in before leaving the premises; otherwise the person signing for it will be required to pay for the unreturned ID Badge.

CONTACT POINTS
Contractor Point of Contact (POC)
The Contractor shall specify an individual who shall serve as a single point of contact for all contract issues (POC). Contractor must provide the COR and Contracting Office with the POC contact details, to include business phone number or cell phone number and email, as a minimum:
Within 5 business days of contract award,
Within 5 business days after renewal or extension of services in accordance with, and if permitted by applicable FAR clause, and
Within 5 business days prior to a change in the POC by the Contractor.
The POC must be easily accessible by phone and return COR calls within 48 hours of a voice message left by the COR.

Contracting Officer s Representative (COR)
Upon contract commencement, the Contracting Officer will notify the Contractor in writing as to the COR assigned to this contract, and upon reassignment of a new COR, as applicable. Contractor shall only respond to requests for service from the COR or the CO. If service is requested from any source, other than the COR or the CO, the Contractor is to advise the individual of this requirement and refuse to respond. Any billing resulting from unauthorized service will not be paid by the government. The COR will evaluate the contractor s performance through review of the Contractor s Quality Control Procedures in accordance with this contract and PWS.

Authority of the COR
The Contracting Officer is the only person authorized to approve changes in any of the requirements of this contract. In the event the Contractor affects any changes at the direction of any person other than the Contracting Officer, the changes will be considered to have been made without authority and no adjustment will be made in the contract price or schedule to cover any increase in costs incurred as a result thereof. The Contracting Officer shall be the only individual authorized to accept nonconforming work, waive any requirement of the contract, and/or modify any term or condition of the contract. The Contracting Officer is the only individual who can legally obligate Government funds. No costs chargeable to the proposed contract can be incurred before receipt of a fully executed contract or specific authorization from the Contracting Officer. Any invoicing or charges resulting from unauthorized service will not be paid by the government.

Government Alternate Points of Contact (POC) Emergencies Only
The COR will identify Alternate Points of Contact (POC) to be used only for instances of emergencies when the COR is not easily contactable. These will be individuals in supervisory or managerial roles within the Biomed department. The contractor will be provided this information within 5 days after contract award and within 48 hours of a change to this information. An Alternate POC does not replace the COR nor do they replace the Contracting Officer during the performance and administration of this contract, nor does it relinquish or diminish the Contractor s requirements in relation to the performance of this Contract.

-LIABILITIES AND INSURANCES
Protection from Damage
Contractor shall provide all labor, materials, and equipment necessary for protection of VAMC personnel, furnishings, equipment, and buildings from damage, and shall replace or repair any damage due to work performed under this contract equal to its original construction and finish.

Liability Insurance
Contractor must provide the COR and the CO with written confirmation that Contractor has adequate insurance protection against negligent work and other forms of liability.

STANDARD BUSINESS HOURS:
Contract performance shall occur during standard business hours unless approved and arranged through the COR. Standard business hours at this location occur between 8:00am to 4:30pm, Monday through Friday, excluding Federal holidays.
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FEDERAL HOLIDAYS:
The Federal Government observes the following days as holidays.
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New Year s Day
January 1st *
Martin Luther King s Birthday
Third Monday in January
Presidents Day
Third Monday in February
Memorial Day
Last Monday in May
Juneteenth
June 19th *
Independence Day
July 4th *
Labor Day
First Monday in September
Columbus Day
Second Monday in October
Veterans Day
November 11th *
Thanksgiving Day
Fourth Thursday in November
Christmas Day
December 25th *
*Holidays that fall on Saturday are observed on the preceding Friday. Holidays that fall on Sunday are observed on the following Monday.
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In addition to the days designated as holidays, the Government observes the following days:
Any other day designated by Federal Statute
Any other day designated by Executive Order
Any other day designated by the President of the United States to be a Federal holiday
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LOCAL VA REPRESENTATIVES:

Upon contract commencement, the Contracting Officer will notify the Contractor of a local VA staff to act as a point of contact assigned to this contract. Contractor shall only respond to requests for service from the VA locally assigned POC, as written in this contract, or the CO. If service is requested from any source, other than the CO, the Contractor is to advise the individual of this requirement and refuse to respond. Any billing resulting from unauthorized service will not be paid by the government. The Government reserves the right to inspect and test services in accordance with this PWS and the Contract.
AUTHORITY TO MAKE CHANGES:
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The Contracting Officer is the only person authorized to approve changes in any of the requirements of this contract. In the event the Contractor affects any changes at the direction of any person other than the Contracting Officer, the changes will be considered to have been made without authority and no adjustment will be made in the contract price or schedule to cover any increase in costs incurred as a result thereof. The Contracting Officer shall be the only individual authorized to accept nonconforming work, waive any requirement of the contract, and/or modify any term or condition of the contract. The Contracting Officer is the only individual who can legally obligate Government funds. No costs chargeable to the proposed contract can be incurred before receipt of a fully executed contract or specific authorization from the Contracting Officer.
SAFETY AND COMPLIANCE:
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The Contractor must perform services in accordance with:
local, state and federal Occupational Safety and Health guidelines and legislation, which includes Occupational Safety and Health Administration (OSHA).
local, state, and federal guidelines and legislation, as well as VA Medical Center Directives and guidelines, relating to chemicals and usage of chemicals.
local, state, and federal Fire and Safety legislation and guidelines, to include VA Medical Center directives and legislation on Fire and Safety, as well as the latest published edition of NFPA-99 (Health Care Facilities Code); and
29 CFR 1910.132, Personal Protective Equipment.
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The contractor is also responsible for immediately notifying the local VA POC at the first instance a safety issue or risk is identified during the Service.

IMPORTANT NOTE: This Sources Sought is for information only (to determine the socioeconomic status of interested companies). No award will be made off of this posting.
LIMITATIONS OF SUBCONTRACTING: The Limitations of Subcontracting may or may not apply to a resulting solicitation from this Market Research. Vendors are advised to familiarize themselves with Federal Acquisition Regulation parts 19.505(a)(2) and 19.505(b)(1) as it pertains to subcontracting limitations. Vendors are also advised to familiarize themselves with 13 CFR 125.6 and the penalties described in this regulation.
Please communicate via e-mail to tiffani.perkins@va.gov by COB 4/17/2024 as to your company s interest and ability to perform service per this brief Scope of Work.
If interested, please provide the following:
Please state your company s business size as related to NAICS code 811210
As per the Limitations of Subcontracting: (see FAR 19.505)
As Primary Contractor: what % of Total Contract Value will you retain?
If using a Subcontractor: what % of Total Contract Value will go to them?
Please provide SAMs Unique Entity Identifier number
If you have an FSS/GSA contract that includes this service
Provide FSS/GSA contract number if applicable
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In order for you company s information to be counted in relation to this Market Research all above questions must be answered.

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