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Maintenance, Testing & Certification of Lab Equipment - Attachment

General Information

Document Type:FILE
Posted Date:Sep 05, 2017
Category: Maintenance, Repair and Rebuilding of Equipment
Set Aside:N/A

Contracting Office Address

Department of Veterans Affairs;Network Contracting Office 2;James J. Peters VA Medical Center;130 West Kingsbridge Road;Bronx NY 10468-3904

Description

Responses to this notice must be submitted in writing via email and must be received not later than Friday, September 15, 2017, 1:00pm EST. No telephone inquiries will be accepted. The purpose of this notice is to gain knowledge of potential qualified sources and their size classification/socioeconomic status (service-disabled veteran owned small business, veteran owned small business, HUB Zone, 8(a), small business or large business). Responses to this notice will be used by the Government to make appropriate acquisition decisions. Responses to this notice should include company/individual name, a service capability statement, examples of similar facilities for which you have provided services to, proof of applicable certification. DUNS number, address, point of contact and social-economic category (ex: SBVOSB, VOSB, 8(a), HUBZone, WOSB, EDWOSB, Small Business). If your firm is a Service-Disabled Veteran Owned or Veteran Owned Small Business, you must be CERTIFIED in VetBiz (see internet site: http://vip.vetbiz.gov). Contractor must be registered in System for Award Management (SAM), formerly CCR (see internet site: http://www.sam.gov). Responses to this notice must be submitted in writing, and received not later than Friday, September, 2017, 1:00pm EST. All interested parties must respond to any related solicitation announcement separately from the responses to this announcement. Email: Delfo.Saco-mizhquiri@va.gov. No telephone inquiries will be accepted. DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. STATEMENT OF WORK REQUIREMENTS: Furnish all necessary labor, equipment, tools, materials, repair service, software updates, parts, etc., for complete On-Site Maintenance Service as specified below in accordance with the terms, conditions and schedule of this Statement of Work. SCOPE OF WORK: Maintenance Service, Testing, and Certification of Lab Equipment including fume hoods, laminar flow hoods, laminar flow biological safety cabinets, clean room, sterile drier and other USP testing as describe below. PERIOD OF PERFORMANCE: One 12-months base year plus 4 option years. EQUIPMENT: Equipment to be Serviced/Maintained includes: LIST OF FUME HOODS: [F10] BLDG 200, RM A3-45, HOOD [F43] BLDG 61, RM 105, HOOD [F4] BLDG 61, RM 107B RADIATION HOOD [F18] BLDG 61, ROOM 107C, L26 [F18] [F17] BLDG 61, ROOM 107E, L27 [F19] BLDG 61, RM 111B, HOOD #6 [F20] BLDG 61, RM 111C, RADIATION HOOD # 8 [F5] BLDG 61, RM 114, HOOD [F21] BLDG 61, RM 120B, RADIATION HOOD # 1 [F22] BLDG 61, RM 120C, RADIATION HOOD # 1 [F25] BLDG 61, RM 127, RADIATION HOOD USED FOR IONIZATION, #7 [F26] BLDG 61, RM 205, HOOD #1 [F28] BLDG 62, RM 205, RADIATION HOOD # 9 [F29] BLDG 62, RM 206A, HOOD #13 [F30] BLDG 62, ROOM 206B, RADIATION HOOD # 7 [F31] BLDG 62, ROOM 206C, HOOD #6 [F32] BLDG 62, ROOM 206D, HOOD #5 [F33] BLDG 62, ROOM 206F, HOOD #12 [F34] BLDG 62, RM 211A, HOOD #4 [F35] BLDG 62, RM 211B, HOOD #3 [F36] BLDG 62, RM 211C, HOOD #2 [F37] BLDG 62, RM 211D, HOOD #1 [F38] BLDG 62, RM 217, HOOD #8 [F39] BLDG 62, RM 218, HOOD #10 [F40] BLDG 62, RM 221B HOOD [F41] BLDG 62, RM 221C HOOD [F42] BLDG 62, RM 227, HOOD #11 [F44] BLDG 200, HISTOLOGY RM B-128B [F45] BLDG 200, HISTOLOGY, 1ST FLOOR, LABCONCO [F46] BLDG 200, HISTOLOGY, 1ST FLOOR, AIRSCIENCE, PURAIR S# P79332 RM B-128A LIST OF LAMINAR FLOW HOODS, LAMINAR FLOW BIOLOGICAL SAFETY CABINETS, CLEAN ROOM AND OTHER EQUIPMENT: [P4] VA ENTRY # 3081, BAKER LAMINAR FLOW BIOLOGICAL SAFETY CABINET ("P4"), MODEL NCB-B4, S/N SP22075V, LOCATED IN BLDG 200, 4TH FLOOR PHARMACY (OPPOSITE PASSENGER ELEVATORS). [P6] VA ENTRY # 440234, NUAIRE LAMINAR FLOW BIOLOGICAL SAFETY CABINET ("P6"), MODEL NU430400, S/N 64293, LOCATED IN BLDG 200N, PHARMACY. USP 797 Particle Count(s) Environmental Viable Particle Test Environmental Viable Control Plate(s) (TSA & MEA) Environmental Viable Surface Test Environmental Viable Surface Control Swab(s) (TSA & MEA) [P7] VA ENTRY (ENTRY # NOT ASSIGNED) NUAIRE LAMINAR FLOW BIOLOGICAL SAFETY CABINET, MODEL NU430-600, S/N 97931040805, LOCATED IN UNIT 31, CHEMOTHERAPY CLEAN ROOM, ROOM A3-20A. USP 797 Particle Count(s) Environmental Viable Particle Test Environmental Viable Control Plate(s) (TSA & MEA) Environmental Viable Surface Test Environmental Viable Surface Control Swab(s) (TSA & MEA) [P9] VA ENTRY # 3319, BAKER BIOLOGICAL SAFETY CABINET, MODEL EG6252, S/N 93520, LOCATED IN MAIN IN-PATIENT PHARMACY, ROOM B1-22, BLDG 200, 1ST FLOOR.. USP 797 Particle Count(s) Environmental Viable Particle Test Environmental Viable Control Plate(s) (TSA & MEA) Environmental Viable Surface Test Environmental Viable Surface Control Swab(s) (TSA & MEA) [P10] CHEMOTHERAPY CLEAN ROOM, BUILDING 200, ROOMS B3-20, B3-20A AND B3-20B. USP 797 Particle Count(s) Environmental Viable Particle Test Environmental Viable Control Plate(s) (TSA & MEA) Environmental Viable Surface Test Environmental Viable Surface Control Swab(s) (TSA & MEA) [L5] VA ENTRY # 8552, LABCONCO PURIFIER CLASS II LAMINAR FLOW BIOLOGICAL SAFETY CABINET ("L5"), MODEL # 36209-08, S/N 215313, LOCATED IN BLDG 200, ROOM C0-C8. [L6] VA ENTRY # 34197, BAKER STERIGARD II LAMINAR FLOW HOOD, MODEL SG400, S/N 57882, LOCATED IN MICROBIOLOGY LAB, BLDG 200, ROOM B1128G. [L7] VA ENTRY # 34197, BAKER STERIGARD II LAMINAR FLOW HOOD, MODEL SG404, S/N 11924, LOCATED IN HISTOLOGY LAB, BLDG 200, 1ST FLOOR. NUMBER OF REQUIRED TESTS PER YEAR: DESCRIPTION TEST OTY Fume Hood Certification Test(s) (F4-F5,F10, Fl7-F22,F25,F26,F28-F46) 30 Fume Hood(s) Tested Semi-Annually 60 Laminar Flow Hood(s) -(P9) I Laminar Flow Hood(s) Tested Semi-Annually 2 B2 Laminar Flow Biological Safety Cabinet(s) _(P6,P7) TWO- B2 Biological Safety Cabinet(s) Tested Semi-Annually 4 Laminar Flow Biological Safety Cabinet(s) _ (L5,L6,L7) THREE_ Biological Safety Cabinet(s) Tested Semi-Annually 6 Clean Room(s) _ (P 10) ONE_ Clean Room Tested Semi-Annually 2 USP 797 Particle Count(s) _ (P4,P6,P7,P9) FOUR_ Tested Semi-Annually 8 Environmental Viable Particle Test(s) (P4,P6,P7,P9,P10) (2) Plates Per Hood (2) Plates Per Room In Each Of The 3 Rooms Total: (192) - (16) Plates Semi-Annual & Monthly 192 Environmental Viable Control Plate(s) (TSA & MEA) (P4,P6,P7,P9,P10) Total: (2) Plates Semi-Annual & Monthly) (2) Control Plates Per Testing Total: (26) Plates Semi-Annual & Monthly 26 Environmental Viable Surface Test(s) (P4,P6,P7,P9,P10) (2) Swabs Per Hood (2) Swabs Per Room In Each Of The 3 Rooms Total: (192) - (16) Swabs Semi-Annual & Monthly) 192 Environmental Viable Surface Control Swab(s) (TSA & MEA) (P4,P6,P7,P9,P10) Total: (2) Plates Semi-Annual & Monthly) (2) Control Swab Per Testing Total: (26) Swabs Semi-Annual & Monthly) 26 Electrical Safety Test(s) _(P4,P6,P7,P9,L6,L7) SIX_ Units Tested Semi-Annually 12 12 (Monthly) Prefilter Replacement(s) & Gauge Readings_ (P9, SICU, TB!, ERi) (4) Units Get Monthly Prefilter(s) 48 10 Air Filtration Unit(s) - Radiology Semi-Annual Prefilter & Carbon Filters Replacement(s) Annual Hepa Filter Replacements 20 3 Biological Controls Air Filtration Unit(s) - Radiology Semi-Annual Prefilter Replacement(s) Annual U.V Bulb & Hepa Filter Replacement(s) 6 1 EO-19 Air Handler Quarterly Prefilter Replacement(s) Annual Hepa Filter Replacement(s) 4 1 Biological Controls Air Filtration Unit(s) (ER1) Emergency Room Semi-Annual Prefilter Replacement(s) Annual U.V Bulb & Hepa Filter Replacement(s) 2 1 Isolation Room Air Handler Unit (SICU1) Monthly Prefilter Replacement Annual Hepa Filter Replacement Semi-Annual Certification Red Bags 12 1 Unit 33 Air Handler (TB1) Monthly Prefilter Replacement Annual Hepa Filter Replacement Semi-Annual Certification Red Bags 12 DEFINITIONS/ACRONYMS: Biomedical Engineering - Chief or designee, Building 11, Room 1, phone # (631) 261-4400 extension 7429. CO - Contracting Officer. COR - Contracting Officer Technical Representative (Biomedical Engineering) PMI - Preventive 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. ESI Electrical Safety Inspection. FSE - Field Service Engineer. A person who is authorized by the contractor to perform maintenance (corrective and/or preventive) services on the VAMC premises. ESR - Vendor Engineering Service Report. A documentation of the services rendered for each incidence of work performance under the terms and condition of the contract. Acceptance Signature - VA employee who indicates FSE demonstrated service conclusion/status and User has accepted work as complete/pending as stated in ESR. Authorization Signature - CORs signature; indicates COR accepts work status as stated in ESR. NFPA - National Fire Protection Association. CDRH - Center for Devices and Radiological Health. VAMC - Department of Veterans Affairs Medical Center OSHA - Occupational Safety and Health Agency. OEM - Original Equipment Manufacturer. AQL Acceptable Quality Level CONFORMANCE STANDARDS: Contract service shall ensure that the equipment (hardware and software) functions in conformance with the latest FDA (medical device regulations (including but not limited to Class I, Class II, Class III and MDDS), validation, quality assurance and compliance), latest published edition of NFPA-99, TJC, OSHA, CDRH, ISO 9001, and any other performance standards and specifications used when the equipment was procured by VA and any upgrades/updates. HOURS OF COVERAGE: Normal business hours of coverage are [Monday through Friday] from [8:00 am to 4:30 pm], excluding federal holidays. All service/repairs will be performed during normal business hours of coverage unless requested and approved by [COR]. Preventive Maintenance (Certification) Inspections will be performed [Semi-Annually]. Monthly inspections will occur [monthly]. Preventive Maintenance Inspections will be performed in the following months: January and July Federal Holidays observed by the VAMC are: New Years Day, Labor Day, Martin Luther King Day, Columbus Day, Presidents Day, Veterans Day, Memorial Day, Thanksgiving Day, Independence Day, Christmas Day, and any other day specifically declared by the President of the United States to be a national holiday. SCHEDULED MAINTENANCE (CERTIFICATION TESTING AND PRE-FILTER REPLACEMENT): The contractor shall perform Certification Testing, Pre-Filter replacement, USP 797 Particle Counts, USP 797CAG-002-2006 Tests, Environmental Viable Particle Tests, Clean Room inspections and Glove Box inspections services to ensure that equipment listed in the schedule performs in accordance with Section III, Conformance Standards. The contractor shall make thorough technical inspections of the equipment covered in the Schedule. Within ten (10) days after the award of the contract, the contractor shall submit a schedule of PMIs and Certification checklists describing in detail the procedures for testing each equipment type listed. This checklist is subject to the approval of the COR. The contractor shall provide and utilize these procedures and checklists with worksheet originals indicating the work performed and actual values obtained (as applicable) shall be provided to the COR at the completion of the PM. All equipment listed under Section C, Equipment, will have Certification service performed Semi-Annually. Certification Inspections will be performed in the months of January and July. In no event shall more than Six (6) months elapse between inspections. Pre-filters for identified equipment shall be replaced Monthly SEMI-ANNUAL TESTING: (30) FUME HOODS (F4-F5, F10, F17-F26, F28-F46) (1) LAMINAR FLOW HOODS (P9) (2) B2 LAMINAR FLOW BIOLOGICAL FLOW SAFETY CABINETS (P4, P7) (2) LAMINAR FLOW BIOLOGICAL SAFETY CABINETS (L5, L6) (1) CLEAN ROOM (P10) (4) USP 797 PARTICLE COUNTS (P4, P6, P7, P9) (1) ENVIRONMENTAL VIABLE PARTICLE TESTS (20 PLATES) (P4, P6, P7, P9, P10) (9) ELECTRICAL SAFETY TESTS (P4, P6, P7, P9, L5, L6) MONTHLY (12) PREFILTER REPLACEMENTS: (4) MONTHLY (12) PREFILTER REPLACEMENTS (P9, SICU, TB!, ERi) CERTIFICATION TESTING OF FUME LISTED HOODS SHALL BE IN ACCORDANCE WITH ALL CURRENT NATIONAL SANITATION FOUNDATION, UNITED STATES PHARMACOPEIA, OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION (OSHA), NUCLEAR REGULATORY COMMISSION (NRC), COLLEGE OF AMERICAN PATHOLOGISTS (CAPS) AND ANY OTHER REGULATORY AGENCY OR APPLICABLE LOCAL, STATE AND FEDERAL CODES, STANDARDS OR REQUIREMENTS. STICKERS BEARING THE VENDOR NAME, DATE OF TEST, DUE DATE FOR NEXT TEST, AND SERVICE TECHNICIANS NAME TO BE AFFIXED TO FUME HOOD IN VISIBLE LOCATION AFTER EACH TEST. RESULTS OF ALL TESTING AND ANY RECOMMENDATIONS TO BE PROVIDED TO BIOMEDICAL ENGINEERING IN BLDG 11, ROOM 1 AFTER TESTING. FOR BIOLOGICAL SAFETY CABINETS, INCLUDES INSPECTION AND CERTIFICATION TWICE ANNUALLY, PERFORMING ALL TESTS SPECIFIED BY THE NATIONAL SANITATION FOUNDATION, AND ANY OTHER GOVERNING STATE, FEDERAL AND INTERNATIONAL REGULATORY AGENCYS STANDARDS. FOR LAMINAR FLOW HOODS, INCLUDES INSPECTION AND CERTIFICATION TWICE ANNUALLY, PERFORMING ALL TESTS SPECIFICED BY IES-CC-002-86; AND ANY OTHER PREVAILING GOVERNING STATE, FEDERAL AND INTERNATIONAL REGULATORY AGENCYS STANDARDS. FOR ALL SYSTEMS CONTAINING PRE-FILTERS, INCLUDES MONTHLY INSPECTION AND WHEN NECESSARY, REPLACEMENT OF FILTERS. INCLUDES LABOR AND THE COST OF PRE-FILTERS. PRE-FILTERS MAY BE STORED AT BIOMEDICAL ENGINEERING. A STICKER BEARING THE DATE OF MONTHLY INSPECTION AND WHETHER PRE-FILTER WAS REPLACED SHALL BE AFFIXED TO THE UNIT. WHERE APPLICABLE, SEMI-ANNUAL INSPECTIONS SHALL INCLUDE AT A MINIMUM: CHECKING AND ADJUSTMENT OF AIR FLOW, CABINET LEAKAGE, AIR INDUCTION, ILLUMINATION, NOISE LEVEL, VIBRATION, ELECTRICAL SAFETY, AND TESTING/REPLACEMENT OF ULTRAVIOLET (UV) LAMPS. COST OF REPLACEMENT UV LAMPS FOUND TO BE INOPERATIVE DURING INSPECTION SHALL BE COVERED. INCLUDES COST OF RE-CERTIFICATION AFTER LAMPS ARE REPLACED. DURING SEMI-ANNUAL CERTIFICATIONS, ANY CONDITION PREVENTING CERTIFICATION SHALL BE BROUGHT TO THE ATTENTION OF BIOMEDICAL ENGINEERING. ONCE APPROVED BY BIOMEDICAL ENGINEERING, AND ASSUMING UNIT HAS NOT BEEN DEEMED BY THE VENDOR TO BE BEYOND ECONOMICAL REPAIR, REPAIR SERVICE SHALL BE AVAILABLE TO COMMENCE WITHIN 48 HOURS ON A TIME & MATERIALS BASIS, REQUIRING A SEPARATE VISA CREDIT CARD TRANSACTION TO PROVIDE PAYMENT. VENDOR SHALL NOT BE EXPECTED TO PERFORM REPAIRS TO ELECTRICAL UTILITIES, MEDICALGAS DELIVERY COMPONENTS, DUCTWORK AND FAN MOTORS BEYOND THE EXTERIOR OF THE CABINET/HOOD. NO PARTS SHALL BE INSTALLED WITHOUT THE PRIOR APPROVAL OF BIOMEDICAL ENGINEERING. RE-CERTIFICATION AFTER REPAIR IS MADE SHALL BE COVERED. PARTS/LABOR SHALL BE WARRANTED FOR ONE (1) MONTH. EMERGENCY SERVICE IS NOT COVERED BY THIS CONTRACT, BUT SHALL BE AVAILABLE WITH A 48 HOUR ON-SITE REPSONSE TIME TO INVESTIGATE PROBLEMS AND RECOMMEND SOLUTIONS, M-F, 8-5.00 PM, EXCLUDING FEDERAL HOLIDAYS, AND SHALL BE PAID FOR ON A TIME & MATERIALS BASIS USING A SEPARATE VISA CREDIT CARD TRANSACTION. AUTHORIZATION TO RESPOND TO AN EMERGENCY ON-SITE PROBLEM MUST BE MADE BY BIOMEDICAL ENGINEERING ONLY. ALL TESTING EQUIPMENT SHALL BE CALIBRATED TO APPROPRIATE INDUSTRYSTANDARDS (IE; NIST, ASTM, IES). A COPY OF CALIBRATION CERTIFICATES SHALL BE PROVIDED UPON REQUEST. ALL UNITS PASSING CERTIFICATION SHALL BE AFFIXED WITH A CERTIFICATION AND/OR INSPECTION STICKER INDICATING INSPECTION DATE, COMPANY NAME, CERTIFIER S NAME AND DUE DATE FOR NEXT SEMI-ANNUAL CERTIFICATION. CHECKLIST DATA SHEETS TO BE SUBMITTED TO BIOMEDICAL ENGINEERING (BLDG11 ROOM 1) FOR EACH EQUIPMENT TESTED/CERTIFIED. PARTICLE COUNT TESTING SHAL BE SEMI-ANNUAL AND CONFORM TO USP 797. USP 797 CAG-002-2006 TESTING ON GLOVE BOX SHALL BE SEMI-ANNUAL. ENVIRONMENTAL VIABLE PARTICLE TESTING SHALL BE CONDUCTED SEMI-ANNUALY, WITH 2 PLATES TAKEN FOR HOODS P1, P3, P4, P7, AND P9, 4 PLATES TAKEN FOR P8, AND P10 SHALL REQUIRE 2 PLATES FOR EACH OF THE THREE ROOMS (ANTE, BUFFER AND CHEMOTHERAPY) WITHIN THE CLEAN ROOM. REPORTING REQUIREMENTS: The contractor shall be required to report to Biomedical Engineering, Building 11, Basement level, Room 1 to log in 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. MONTHLY REPORTS: Records of all PM Inspections, Repairs Requested and Performed under this contract. ADDITIONAL CHARGES: There will be no additional charge to the Government for time spent at the site during, or after the normal hours of coverage awaiting the arrival of additional FSE and/or delivery of parts. REPORTING REQUIRED SERVICES BEYOND THE CONTRACT SCOPE: The Contractor shall immediately, but not 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. QUALIFICATIONS: Offers will be considered only from offerors who are established in the business called for and whom in the judgment of the Contracting Officer (CO) are financially responsible and able to show evidence of their reliability, ability, experience, equipment, facilities and personnel directly employed or supervised by them to render prompt and satisfactory service. CONDITION OF EQUIPMENT: The contractor accepts responsibility for the equipment described "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. COMPETENCY OF PERSONNEL SERVICING EQUIPMENT: 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 comparable to that identified in the Section B schedule. For field experience, the FSE(s) has a minimum of one year of experience, with respect to scheduled and unscheduled preventive and remedial maintenance on covered equipment. 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. 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 the COR specifically reserve the right to reject any of the contractors personnel and refuse them permission to work on the VAMC equipment. If subcontractor(s) are used, they must be approved by the CO; the contractor shall submit any proposed change in subcontractor(s) to the CO for approval/disapproval. TEST EQUIPMENT: Contractor is required to utilize testing equipment for calibration which has been certified to be accurate, with accuracy traceable to a national standard. Certification certificates shall be made available to COR upon demand IDENTIFICATION, PARKING, SMOKING, AND VA REGULATIONS: The contractors FSEs shall wear visible company identification at all times while on the premises of the VAMC. It is the responsibility of the contractor to park in the appropriate designated parking areas. Smoking is prohibited inside any buildings at the VAMC or near entranceways. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to police search. Violations of VA regulations may result in citations answerable in the United States (Federal) District Court. SECURITY: VA Handbook 6500.6, Contract Security - APPENDIX C. DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.

Original Point of Contact

POC Delfo Saco-mizhquiri

Place of Performance

Address:
Department of Veterans Affairs;Northport VA Medical Center;79 Middleville Road;Northport, NY.
11768,
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