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FBO DAILY - FEDBIZOPPS ISSUE OF DECEMBER 22, 2017 FBO #5873
DOCUMENT

J -- Maintenance, Testing & Certification of Lab Equipment at Northport VAMC - Attachment

Notice Date

12/20/2017
 

Notice Type

Attachment
 

NAICS

541990 — All Other Professional, Scientific, and Technical Services
 

Contracting Office

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

ZIP Code

10468-3904
 

Solicitation Number

36C24218Q0111
 

Response Due

1/4/2018
 

Archive Date

2/3/2018
 

Point of Contact

Delfo Saco-mizhquiri
 

Small Business Set-Aside

N/A
 

Description

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, Testing, and Certification of Lab Equipment including: fume hoods, laminar flow hoods, biological safety cabinets, clean room certifications and sampling, operating room air quality portable HEPA filtration units, Isolation/negative pressure rooms filtration, air handler filtration, hood and cabinet bulb replacements, and other USP testing as described below. PERIOD OF PERFORMANCE: One 12-months base year plus 4 option years. EQUIPMENT: Equipment to be Certified 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, BIOLOGICAL SAFETY CABINETS, CLEAN ROOMS 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 NU430-400, S/N 64293, LOCATED IN BLDG 200N, Section 2F, Room E2-49 PHARMACY. [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. [P8] VA ENTRY # 21912, BAKER STERISHIED BARRIER ISOLATOR (GLOVE BOX), MODEL SS500, S/N 93206 GLOVE BOX LOCATED IN BLDG 200, 4TH FLOOR PHARMACY (OPPOSITE PASSENGER ELEVATORS). [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. [P10] CHEMOTHERAPY CLEAN ROOM, BUILDING 200, Unit 31, ROOMS B3-20, B3-20A AND B3-20B. [No hood this is the clean room information] [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 1 Glove Box (P8) Tested Semi-Annually 2 Laminar Flow Hood -(P9) I Laminar Flow Hood 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 _ (P 10) ONE_ Clean Room Tested Semi-Annually 2 USP 797 Particle Count(s) _ (P7,P9) TWO_ Tested Semi-Annually 4 Environmental Viable Particle Test(s) (P7,P9,P10) [2 HOODS & 1 CLEAN ROOM] (2) Plates Per Hood [ 4 plates] (2) Plates Per Room In Each Of The 3 Rooms [6 plates] Total: (120) - (10) Plates Monthly 120 Environmental Viable Control Plate(s) (TSA & MEA) (P7,P9,P10) Total: (2) Plates Monthly [4 plates + (6 FOR P10 -3 ROOMS)] (2) Control Plates Per Testing [2 plates] Total: (24) Plates Semi-Annually 24 Environmental Viable Surface Test(s) (P7,P9,P10) (2) Swabs Per Hood [4 plates] (2) Swabs Per Room In Each Of The 3 Rooms [6 plates] Total: (120) - (10) Swabs Monthly 120 Environmental Viable Surface Control Swab(s) (TSA & MEA) (P7,P9,P10) Total: (2) Plates Monthly [10 PLATES] (2) Control Swab Per Testing Total: (24) Swabs Semi-Annually 24 Electrical Safety Test(s) _(P4,P6,P7,P9,L6,L7) SIX_ Units Tested Semi-Annually 12 12 (Monthly) Prefilter Replacement(s) & HEPA Filters Status Assessment if equipped with Gauges_ (P9, SICU, TB1, ER1) (4) Units Get Monthly Prefilter(s) 48 10 Air Filtration Unit(s) Semi-Annual Prefilter & Carbon Filters Replacement(s) Annual Hepa Filter Replacements 20 3 Biological Controls Air Filtration Unit(s) 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 & Magna-Helic Gauge reading Annual Hepa Filter Replacement Semi-Annual Certification Red Bags 12 1 Unit 33 Air Handler (TB1) Monthly Prefilter Replacement & Magna-Helic Gauge reading Annual Hepa Filter Replacement Semi-Annual Certification Red Bags 12 GLOVED FINGER TIP SAMPLING - 23 PHARMACISTS 4 PLATES EACH [92 PLATES] [2 PLATES BEFORE SIMMULATION AND TWO PLATE AFTER SIMULATION Annual TESTING *****VENDOR PROVIDES - PICK UP PROCEDURE FOR INCUBATION ***** 92 5 Operating Rooms (2 HEPA FILTERS ea.) Air flow measurements Air exchange calculations Positive pressure measurements Quarterly Hepa Filter Replacement 40 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 - COR's 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, President's 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 Quarterly Testing: (5) OPERATING ROOMS AIR QUALITY MEASUREMENTS (40) HEPA FILTER REPLACEMENTS 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, TB1, ER1) CERTIFICATION TESTING OF FUME HOODS LISTED 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 TECHNICIAN'S 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 AGENCY'S 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 AGENCY'S 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, OR ANY 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 contractor's 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 contractor's FSE's 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 A SOLICITATION WILL BE RELEASED SOON.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/BroVANAP/VAMD/36C24218Q0111/listing.html)
 

Document(s)

Attachment
 

File Name: 36C24218Q0111 36C24218Q0111_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3976659&FileName=36C24218Q0111-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3976659&FileName=36C24218Q0111-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Place of Performance

Address: Department of Veterans Affairs;Northport VAMC;79 Middleville Road;Northport

Zip Code: 11768
 

Record

SN04772313-W 20171222/171220231123-22e1367b931b814cbe83435e6d0255e3 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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