RFQ 36C24822Q1164.pdf
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- Solicitation number
- 36C24822Q1164
About this file
This federal contract opportunity notice seeks sterile processing service equipment for the Department of Veterans Affairs VA Caribbean Healthcare System and Ponce Outpatient Clinic in Puerto Rico. Required equipment includes two sterile driers or drying cabinets, one cart washer, two steam sterilizers, two ultrasonic cleaners, and two washer disinfectors. The solicitation will be set aside for Service-Disabled Veteran Owned Small Businesses and is scheduled to be posted on June 30, 2022 via beta.sam.gov. Offerors must be registered in SAM to be eligible for award. The primary NAICS code is 339113 for Surgical Appliance and Supplies Manufacturing.
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PAGE 1 OF 1. REQUISITION NO.
2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE
a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL
TIME
9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:
SMALL BUSINESS
HUBZONE SMALL
BUSINESS
SERVICE-DISABLED
VETERAN-OWNED
SMALL BUSINESS
WOMEN-OWNED SMALL BUSINESS
(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED
SMALL BUSINESS PROGRAM
EDWOSB
8(A)
NAICS:
SIZE STANDARD:
11. DELIVERY FOR FOB DESTINA-
TION UNLESS BLOCK IS
MARKED
SEE SCHEDULE
12. DISCOUNT TERMS
13a. THIS CONTRACT IS A
RATED ORDER UNDER
DPAS (15 CFR 700)
13b. RATING
14. METHOD OF SOLICITATION
RFQ IFB RFP
15. DELIVER TO CODE 16. ADMINISTERED BY CODE
17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE
TELEPHONE NO. UEI: EFT:
PHONE: FAX:
17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER
18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED
SEE ADDENDUM
19. 20. 21. 22. 23. 24.
ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
(Use Reverse and/or Attach Additional Sheets as Necessary)
25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)
27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.
27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED
28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:
30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)
30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED
AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)
PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212
7. FOR SOLICITATION
INFORMATION CALL:
STANDARD FORM 1449
SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES
OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30
36C24822Q1164 06-30-2022
Jessica Kiser 407-646-4005 07-13-2022
16:00 EDT
36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Orlando VA Healthcare System 13800 Veterans Way Orlando FL 32827
X 100
X
339113
750 Employees
N/A
X
36C672
Department of Veterans Affairs VA Caribbean Healthcare System Reference C.8 for delivery.
36C248
Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Orlando VA Healthcare System
Financial Services Center
P.O. Box 149971 Austin TX 78714-9971
(877) 353-9791 (512) 460-5429
See CONTINUATION Page
Solicitation for Sterile Processing Service Equipment for VA Caribbean Healthcare System
Reference C.8 for alternate delivery location.
See CONTINUATION Page
X X
X 1
36C24822Q1164
Table of Contents
SECTION A
A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND
COMMERCIAL SERVICES
SECTION B - CONTINUATION OF SF 1449 BLOCKS
B.1 CONTRACT ADMINISTRATION DATA
B.2 PRICE/COST SCHEDULE/ITEM INFORMATION
B.3 DELIVERY SCHEDULE
B.4 STATEMENT OF WORK
B.5 IT CONTRACT SECURITY
SECTION C - CONTRACT CLAUSES
C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS
AND COMMERCIAL SERVICES (NOV 2021)
C.2 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)
C.3 VAAR 852.204-70 PERSONAL IDENTITY VERIFICATION OF CONTRACTOR
PERSONNEL (MAY 2020)
C.4 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA
ACQUISITION OF COMMERCIAL ITEMS (APR 2020)
C.5 VAAR 852.212-71 GRAY MARKET ITEMS (APR 2020)
C.6 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND
COMPLIANCE (JUL 2018)
C.7 VAAR 852.219-78 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—
CERTIFICATE OF COMPLIANCE FOR SUPPLIES AND PRODUCTS (SEP 2021)
(DEVIATION)
C.8 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)
C.9 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)
C.10 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT
STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND
COMMERCIAL SERVICES (JAN 2022) (JUL 2020) (DEVIATION)
SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS
D.1 ATTACHMENT A LIMITATION ON SUBCONTRACTING CERTIFICATION
D.2 ATTACHMENT B ZONE D FLOOR PLAN POWER
D.3 ATTACHMENT C ZONE D WATER DISTRIBUTION LAYOUT
D.4 ATTACHMENT D ZONE D SANITARY LAYOUT
D.5 ATTACHMENT E SPS EQUIPMENT LOCATION
SECTION E - SOLICITATION PROVISIONS
E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND
COMMERCIAL SERVICES (NOV 2021)
E.2 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB
1998)
E.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS
AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)
E.4 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)
E.5 52.216-1 TYPE OF CONTRACT (APR 1984)
E.6 52.233-2 SERVICE OF PROTEST (SEP 2006)
E.7 52.212-2 EVALUATION-COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES
(NOV 2021)
E.8 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL
PRODUCTS AND COMMERCIAL SERVICES (NOV 2021) (JUL 2020) (DEVIATION)
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:
b. GOVERNMENT: 36C248- Contracting Officer: Norbert Reed, Norbert.Reed@va.gov Contract Specialist: Jessica Kiser, Jessica.Kiser@va.gov
Network Contracting Office 8 (NCO 8) Orlando VA Healthcare System
2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:
[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or [] 52.232-36, Payment by Third Party
3. INVOICES: Invoices shall be submitted in arrears:
a. Quarterly []
b. Semi-Annually []
c. Other [X] Upon receipt by the VA warehouse.
4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.
5. FSC MANDATORY ELECTRONIC INVOICE SUBMISSION: Contractors are required to submit payment requests in electronic form in accordance with the submission instructions below.
TUNGSTEN ELECTRONIC INVOICE SUBMISSION
FSC e-INVOICE PROGRAM THRU AUSTIN PORTAL
FSC MANDATORY ELECTRONIC INVOICE SUBMISSION FOR AUSTIN PAYMENTS
a. Vendor Electronic Invoice Submission Methods:
Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests.
Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods below.
1. VA’s Electronic Invoice Presentment and Payment System – The FSC uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission. Please go to this website: http://www.tungsten-network.com/US/en/veterans-affairs/ to begin submitting electronic invoices, free of charge.
http://www.tungsten-network.com/US/en/veterans-affairs/
2. A system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) chartered by the American National Standards Institute (ANSI). The X12 EDI Web site (http://www.x12.org)
b. Vendor e-invoice Set-Up Information:
Please contact Tungsten at the phone number or email address listed below to begin submitting your electronic invoices to the VA Financial Services Center for payment processing, free of charge. If you have question about the e-invoicing program or Tungsten, please contact the FSC at the phone number or email address listed below.
1. Tungsten e-Invoice Setup Information: 1-877-489-6135
2. Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com
3. FSC e-Invoice Contact Information: 1-877-353-9791
4. FSC e-invoice email: vafsccshd@va.gov
See https://www.fsc.va.gov/einvoice.asp for more information.
ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:
AMENDMENT NO DATE
B.2 PRICE/COST SCHEDULE/ITEM INFORMATION
ITEM
NUMBER
DESCRIPTION OF
SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT
2.00 EA __________________ __________________
Brand Name or Equal: Sterile Drier or Drying Cabinet for Sterile Surgical
Instruments PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing PRODUCT/SERVICE CODE: 6530 - Hospital Furniture, Equipment, Utensils, and Supplies
MANUFACTURER PART NUMBER (MPN): 54344
0001AA
1.00 EA __________________ __________________
One each for Ponce Outpatient Clinic in Ponce, PR.
PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing PRODUCT/SERVICE CODE: 6530 - Hospital Furniture, Equipment, 0001AB
One each for VA Caribbean Healthcare System in San Juan, PR.
PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing PRODUCT/SERVICE CODE: 6530 - Hospital Furniture, Equipment, http://www.x12.org/ mailto:VA.Registration@Tungsten-Network.com mailto:vafsccshd@va.gov https://www.fsc.va.gov/einvoice.asp
Brand Name or Equal: Cart Washer
PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing PRODUCT/SERVICE CODE: 6530 - Hospital Furniture, Equipment, MANUFACTURER PART NUMBER (MPN): 9128E-001
Brand Name or Equal: Steam Sterilizer
PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing PRODUCT/SERVICE CODE: 6530 - Hospital Furniture, Equipment, MANUFACTURER PART NUMBER (MPN): 7LFVUPHTAAAA
Brand Name or Equal: Ultrasonic Cleaning System
PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing PRODUCT/SERVICE CODE: 6530 - Hospital Furniture, Equipment, MANUFACTURER PART NUMBER (MPN): 6003000805
0004AA
One each for Ponce Outpatient Clinic in Ponce, PR.
PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing PRODUCT/SERVICE CODE: 6530 - Hospital Furniture, Equipment, 0004AB
One each for VA Caribbean Healthcare System in San Juan, PR.
PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing PRODUCT/SERVICE CODE: 6530 - Hospital Furniture, Equipment, Washer Disinfector with double door
PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing PRODUCT/SERVICE CODE: 6530 - Hospital Furniture, Equipment, MANUFACTURER PART NUMBER (MPN): 8DHSEBFNNBSUNNN
Installation for Ponce Outpatient Clinic and VA Caribbean Healthcare
System in San Juan, PR.
PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing PRODUCT/SERVICE CODE: 6530 - Hospital Furniture, Equipment, NATIONAL STOCK NUMBER: NONE
GRAND TOTAL __________________
B.3 DELIVERY SCHEDULE
ITEM NUMBER QUANTITY
DELIVERY
DATE
0001 2.00 150 Days ARO
0001AA SHIP TO: Department of Veterans Affairs Ponce Outpatient Clinic
PR14, KM 3.6
Ponce, PR 00716
USA
1.00 150 Days ARO
MARK
FOR:
To Be Determined
0001AB SHIP TO: Department of Veterans Affairs VA Caribbean Healthcare System #35 Jose Tony Santana Ave Carolina, PR 00979
FOR:
To Be Determined
0002 SHIP TO: Department of Veterans Affairs Ponce Outpatient Clinic
PR14, KM 3.6
FOR:
To Be Determined
0003 SHIP TO: Department of Veterans Affairs Ponce Outpatient Clinic
PR14, KM 3.6
2.00 150 Days ARO
FOR:
To Be Determined
0004 1.00 150 Days ARO
0004AA SHIP TO: Department of Veterans Affairs
PR14, KM 3.6
MARK
FOR:
To Be Determined
0004AB SHIP TO: Department of Veterans Affairs VA Caribbean Healthcare System #35 Jose Tony Santana Ave Carolina, PR 00979
FOR:
To Be Determined
0005 SHIP TO: Department of Veterans Affairs Ponce Outpatient Clinic
PR14, KM 3.6
FOR:
To Be Determined
0006 SHIP TO: Department of Veterans Affairs Ponce Outpatient Clinic
PR14, KM 3.6
FOR:
To Be Determined
B.4 STATEMENT OF WORK
Sterile Processing Service Equipment for VA Caribbean Healthcare System
1.0 General
The Department of Veterans Affairs (VA), Network Contracting Office 08, requires Sterile Processing Equipment for the Sterile Processing Services (SPS) in Caribbean VA Healthcare System (VAHCS) in San Juan, Puerto Rico and Ponce Outpatient Clinic.
1.1 Background
The VA Caribbean Healthcare System in San Juan and Ponce Outpatient Clinic (POPC) requires the following equipment and installation for Cart Washers, Steam Sterilizers, Sterile Driers and/or Drying Cabinets, Ultrasonic Cleaners and Washer Disinfector for SPS.
A new Ponce Outpatient Clinic is replacing Ponce Outpatient Clinic located in “Paseo Del Veterano” Road, Ponce, PR. The site is estimated to be in activation period after July 1, 2022. VACHS requires a Contractor to provide the SPS equipment specified in this statement of work and coordinate efforts with SPS staff and contracting personnel to ensure equipment is installed and functional prior to opening its clinic doors early 2023.
The Contractor shall provide all labor, materials, equipment, transportation, installation, and supervision necessary to satisfy the requirement.
2.0 General Requirements
The Contractor shall provide the following equipment Brand Name or Equal:
MINIMUM SALIENT CHARACTERISTICS:
a. CART WASHER SYSTEM
- One (1) each Cart Washer Shall include:
• Chamber size: Length 112.2” x 37.8” Width x 78.7” Height
• Two (2) carts that allow for case container, container utensil and surgical instrument cleaning with container lid support
• Inclined door with passthrough
• Stainless steel finish, rust proof and trim panel mounted
• Performance dryer
• Steam heated higher than 400 voltages
• Deionized water valve
• Water docking for wash carts
• Detergent pump
• Printer
• Programable and customizable cleaning cycles including a surgical instrument cycle
• Direct rinse system to ensure removal of detergent
• High water flow, oscillating sprays
b. STEAM STERILIZER
- Two (2) each Steam Sterilizers Shall include:
• Chamber size: 61” inches
• Chamber capacity for 20 trays per load
• Powered double door, left hand/right hand slide swing
• Stainless steel construction
• Two (2) each loading trolley carts
• Two (2) each shelf racks
• Validated for gravity and pre-vacuum cycles at either 132 Celsius or 135 Celsius
• Gravity cycles, Pre-Vacuum, Bowie & Dick cycle, high-vacuum cycles, and vacuum-leak test cycle
c. ULTRASONIC CLEANER
- Two (2) each Ultrasonic Cleaner with large capacity to reprocess complex surgical instruments trays -- One each for Ponce location -- One each for San Juan location Shall include:
• Ultrasonic cavitation cycle for lumened instruments
• Dedicated cycle validated for DaVinci S/SI ™ and Xi ™ robotic instrumentation
• Automatic powered lid opening and load tray elevator
• Reprocessing capacity of up six trays by load
• Slide and lock mechanism for loading of trays
• Lumened cleaning cycle and dedicated ports (12 ports/tray)
• Fully automatic washing, flushing and air purge
• Independent basins operation
• 80 pounds total weight capacity of reprocessing
• Efficient cavitation technology for removal of blood and debris
d. STERILE DRIER or DRYING CABINET
- Two (2) each Sterile Driers with high capacity for drying and storage of surgical instruments -- One each for Ponce location -- One each for San Juan location Shall include:
• Individual High Efficiency Particulate Air (HEPA) filter to remove 99% of airborne particles
• Transparent doors for easy visualization of surgical instrument and devices
• Slide out tube holders
• Removable trays
• Vertical airflow
• Thermostat control for temperature adjustments
• Timer
• Hospital grade features for electrical connections
• Aluminum trays
• Rust proof construction
e. WASHER DISINFECTOR
- Two (2) each Washer Disinfector with high capacity for reprocessing Shall include:
• Large chamber size (up to 12 cubic feet)
• Large reprocessing capacity (12 trays) for each wash cycle
• Two (2) each loading trolley carts
• Two (2) each wash carts with adjustable racks including a cannulated /lumened wash cart
• Easy to read panel to minimize human error when selecting cycles
• Double door
• Automated loading and unloading of trays
• Gentle cycle for delicate instruments
• Automatic detergent smart fill
• Large visible status indicators
• Orthopedic, robotic instruments and case container washing cycles
• Rack recognition technology for correct cycle selection
• Adjustable shell racks
• Adjustable shelves that can adapt to different load heights
• Thermal disinfection capacity
• Shelf racks for Lumened or cannulated surgical instruments
3.0 Installation Requirements:
The Contractor shall provide all labor, materials, equipment, transportation, and supervision necessary to satisfy the needs of described above.
All work and installation shall be coordinated with the Sterile Processing, Biomedical Engineering and Facility Management point of contacts. The installation shall occur at the discretion of the point of contact (to be determined during the kickoff meeting).
1. Assembly, connection and testing of equipment shall be provided by qualified service technicians.
2. The Contractor shall provide a timeline from cradle to grave to include manufacturing lead times, delivery to the location, assembly, connection and testing of the equipment.
3. The Contractor shall coordinate with Facility Management and Engineers for electrical connections with the equipment outlet boxes and facility power, see attached drawings in Section D.
4. The Contractor shall uncrate all items received, verify and inspect prior to installation. Any and all deficiencies (damage/overage/shortage) shall be brought to the attention to the CO in writing, via email, immediately upon identification.
5. The Contractor shall perform all required assembly in accordance with the manufacturer’s instructions.
6. The Contractor shall assemble, connect equipment to utility sources and test equipment for functionality prior to operational use.
7. The Contractor shall train SPS personnel and Biomedical staff on all equipment operations.
8. The drawings for facility power, water distribution and sanitation lines are attached in Section D.
DELIVERABLES
a. CART WASHER:
1. The Cart Washer shall fit the space area of 107 5/16” inches Length x 291 3/8”inches Width.
2. Contractor shall assemble the Cart Washer and connect reverse osmosis, cold and hot water, steam, condensate, exhaust, drain and compressed air connections between the existing facility supply lines and equipment.
b. STEAM STERILIZER:
1. The Steam Sterilizers shall fit a wall opening of 45” inches Width x 73 3/8” inches Height.
2. The Contractor shall assemble the steam sterilizers with the following measurements: 36’ft 4” inches Length x 72” inches Width.
3. The Contractor shall connect water, steam, condensate, and air connections between the existing facility supply lines and equipment.
c. ULTRASONIC CLEANER The Contractor shall assemble the ultrasonic cleaner and connect reverse osmosis, cold and hot water, drain and air connections between the existing facility supply lines and equipment.
d. STERILE DRIER The Contractor shall assemble the Sterile Drier and level test functionality for operation use.
e. WASHER DISINFECTOR
1. The Contractor shall assemble two large capacity washer disinfectors to fit a wall opening with the current dimensions of 48” inches Width x 75” inches Height, with no additional structural changes or construction.
2. The Contractor shall connect reverse osmosis, cold and hot water, steam, exhaust, condensate return, drain and air connections between the existing facility supply lines and equipment.
4.0 Kickoff Meeting
The prime Contractor(s) shall participate in a kickoff meeting within ten (10) days after award, via online. Time and date will be determined by the CO upon award.
The Contractor shall be prepared to provide installation drawings and installation instructions after award.
5.0 Warranty and Support
The warranty period starts upon installation and acceptance of the equipment.
The warranty of the equipment shall be provided for at least one year for parts and labor.
The Contractor agrees to furnish, without cost to the Government, replacement of all parts and equipment which are found to be defective during the warranty period. The cost of installation and travel of replacement material and parts shall be borne by the Contractor.
For one year only: the vendor/Contractor shall have the availability and capacity to respond within 24 hours for onsite troubleshooting. Must have physical representation in Puerto Rico to service the Cart Washer, Sterile Drier/Drying Cabinet, Steam Sterilizer, Ultrasonic Cleaner and Washer Disinfector stated above to avoid interruption of patient care. Provide a point of contact and address of the representative.
The Contractor shall provide one (1) set of user manuals and technical manuals to VA Biomedical Engineering.
6.0 Testing
The testing of equipment shall be completed to ensure equipment works properly prior to operation utilization.
7.0 Operations and Storage Areas
The Contractor shall confine all operations (including storage of materials) on Government premises to areas authorized and approved by the Contracting Officer. The Contractor shall hold and save the Government, its officers and agents, free and harmless from liability of any nature occasioned by the Contractor's performance. Point of Contact will provide contractor staging area information upon work start date.
The Contractor shall be made aware of and must comply with local security policies and procedures in the purchase order. The Contractor will comply to these standards during all site visits on Governmental property. Contractor shall contact the VA point of contact (determined after award) at least 14 days prior to work start date to ensure compliance to any local security policies.
The Contractor shall adhere to local VA policies and procedures to protect the safety and welfare of customers, employees, and the community to minimize or eliminate safety or environmental risks.
The Contractor personnel shall present a professional appearance and shall have a uniform or some method of identifying them as an employee of the Contractor. A VA badge will be provided and must be worn above the waist and be visible at all times while on Government property.
Debris shall be removed daily by the Contractor unless otherwise directed.
All personal automobiles and Contractor trucks shall be parked at the Contractor's staging area or offsite of the VA premises.
Execute work to interfere as little as possible with normal functioning of the VA facility including operations of utility services, fire protection systems and any existing equipment, with work being done by others. Do not store materials and equipment in other than the designated Contractor storage areas.
Daily, Contractor shall keep work, storage, and staging areas clean and neat. Contractor shall provide enough trash containers so that there is no debris lying around. The containers shall be emptied at least weekly and more frequently, if needed.
8.0 Protection of Existing Structures, Equipment, Utilities, And Improvements The Contractor shall preserve and protect all structures and equipment on or adjacent to the work site. The Contractor shall replace at his own expense damage to such items to the satisfaction of the Contracting Officer.
Contractor shall take all measures and provide all materials necessary for protecting and preserving existing equipment and property in affected areas of installation against dust, debris and physical damage, so that equipment and affected areas to be used in the medical center operations shall not be hindered.
Contractor shall permit access to VA personnel through installation areas as required for maintenance and normal VA operations.
When the installation area is turned over to Contractor, Contractor shall accept entire responsibility, therefore. Contractor shall maintain in operating condition, existing fire protection, alarm equipment and other operating equipment in the installation area. It is very important that essential and life safety systems be continuously maintained and not interrupted without two weeks prior written notice and approval from the CVAHCS.
9.0 Sign-In Procedures
Any Contractors from the mainland to perform any work regarding this procurement will be required a negative COVID-19 molecular assay for detection of SARS-CoV-2 RNA within 3-5-days of service. The vendor/Contractor must be evaluated at hospital entrance checkpoint to check temperature and COVID-19 related symptoms. The Vendor/Contractor should always wear a facemask for source control, while in the facility.
All Contractor workers are required to sign in and out at the VA Police Dispatch at the corresponding locations as directed by the POINT OF CONTACT or designee at each facility. A valid state driver’s license or state identification card is mandatory for all employees to have access to these facilities. All Contractor employees are required to wear the assigned VA badge always.
Everyone entering the VA Caribbean Healthcare System facility is screened and visitors are limited. Face coverings are mandatory. Anyone with any symptoms of COVID-19 is not permitted inside the facility.
10.0 Work Hours
Normal business hours are 7:30AM to 4:00PM Monday thru Friday excluding Federal Holidays.
New Year’s Day Birthday of Martin Luther King, Jr.
Washington's Birthday Memorial Day Juneteenth Day Independence Day
Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day
Requests for afterhours work must be submitted in writing to the Point of Contact and Contracting Officer two (2) weeks prior to work. The VA requires that information submitted must contain extent of work, workers involved, the affected areas, and the estimated times of operation. Subject to COVID-19 restrictions and approval.
11.0 Id Badges
All workers are required to obtain a time-limited I. D. badge from the VA Police Service located on the ground floor of Building 203. This badge must always be worn when workers are on site.
The Certification and Accreditation (C&A) requirements do not apply and a Security Accreditation Package is not required for this SOW.
B.5 IT CONTRACT SECURITY
VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY
1. 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.
2. 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.
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.
3. 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 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 COR.
4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT
a. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program).
During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.
b. The contractor/subcontractor shall certify to the COR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required.
c. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default "program files" directory and silently install and uninstall.
d. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges.
e. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle.
f. The contractor/subcontractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties.
g. The contractor/subcontractor agrees to:
(1) Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies:
(a) The Systems of Records (SOR); and
(b) The design, development, or operation work that the contractor/ subcontractor is to perform;
(1) Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a SOR on individuals that is subject to the Privacy Act; and
(2) Include this Privacy Act clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a SOR.
h. In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SOR on individuals to accomplish an agency function, the contractor/subcontractor is considered to be an employee of the agency.
(1) "Operation of a System of Records" means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records.
(2) "Record" means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and contains the person's name, or identifying number, symbol, or any other identifying particular assigned to the individual, such as a fingerprint or voiceprint, or a photograph.
(3) "System of Records" means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.
i. The vendor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as "Systems"), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hotfixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the vendor anywhere in the Systems, including Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems.
j. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than five days.
k. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within ten days.
l. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g., for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology.
5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE
a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks.
This includes conducting compliant risk assessments, routine vulnerablity scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system.
The contractor's security control procedures must be equivalent to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA's network involving VA information must be reviewed and approved by VA prior to implementation.
b. Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII.
c. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor's systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office. Government- owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks.
d. The contractor/subcontractor's system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA's POA&M management process. The contractor/subcontractor must use VA's POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/ subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re- authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary.
e. The contractor/subcontractor must conduct an annual self assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost.
f. VA prohibits the installation and use of personally-owned or contractor/ subcontractor-owned equipment or software on VA's network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All of the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VA-approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE.
g. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.)
used by the contractors/ subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract.
h. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are:
(1) Vendor must accept the system without the drive;
(2) VA's initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or
(3) VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.
(4) Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;
(a) The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and
(b) Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools.
Applicable media sanitization specifications need to be pre-approved and described in the purchase order or contract.
(c) A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation.
6. 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 COR 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…
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