36C24W24Q0057.docx
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- Attached to
- 6515--Copy of Medication Distribution Cabinets
- Solicitation number
- 36C24W24Q0057
- Issued by
-
Department of Veterans Affairs
About this file
This document is a solicitation for the purchase of Medication Distribution Systems, including Omnicell XT automated medication dispensing cabinets, for the VA San Diego Healthcare System. The government is seeking 8 controlled substance dispensers, 164 metal locking drawers, 4 XT MED 2-cell cabinets, and 4 XT MED 3-cell cabinets, along with various accessories and software licenses. The cabinets must be compatible with the existing Omnicell Omnicenter software and integrate with the VA's VISTA and CPRS systems.
The solicitation has an estimated delivery period of July 2024 to November 2024, with the items to be delivered to the new SCI/CLC building at the VA San Diego Healthcare System. The contract is set-aside for certified Service-Disabled Veteran-Owned Small Businesses (SDVOSBs). There are specific requirements regarding limitations on subcontracting that bidders must meet. Bidders must be listed as certified SDVOSBs in the SBA certification database to be eligible for award.
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Text version
36C24W24Q0057
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
36C24W24Q0057 Dr. Vinicky Ann Ervin Ph.D.
210-649-6306 04-05-2024 6:00
CDT
Regional Procurement Office West (RPOW) Dr. Vinicky Ann Ervin Ph.D.
3237 Peacekeeper Way Building 200 Suite 204 McClellan Park
CA
95652 X X Y 339112 1000 Employees N/A X Department of Veterans Affairs VA San Diego Medical Center 3350 La Jolla Village Dr.
San Diego
CA
92161 Regional Procurement Office West (RPOW) 3237 Peacekeeper Way Building 200 Suite 204 McClellan Park
CA
95652
See CONTINUATION Page $0.00 See CONTINUATION Page X Table of Contents
| SECTION A | 1 |
| A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES | 1 |
| SECTION B - CONTINUATION OF SF 1449 BLOCKS | 4 |
| B.1 CONTRACT ADMINISTRATION DATA | 4 |
| B.2 IT CONTRACT SECURITY | 5 |
| B.3 PRICE/COST SCHEDULE | 22 |
| ITEM INFORMATION | 22 |
| B.4 DELIVERY SCHEDULE | 24 |
| SECTION C - CONTRACT CLAUSES | 33 |
| C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2023) | 33 |
| C.2 52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989) | 38 |
| C.3 52.217-7 OPTION FOR INCREASED QUANTITY—SEPARATELY PRICED LINE ITEM (MAR 1989) | 39 |
| C.4 VAAR 852.219-73 VA NOTICE OF TOTAL SET-ASIDE FOR CERTIFIED SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESSES (JAN 2023) (DEVIATION) | 39 |
| C.5 VAAR 852.219-76 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—CERTIFICATE OF COMPLIANCE FOR SUPPLIES AND PRODUCTS (JAN 2023) (DEVIATION) | 42 |
| C.6 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018) | 44 |
| C.7 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) | 45 |
| C.8 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018) | 45 |
| C.9 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998) | 46 |
| C.10 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2023) (DEVIATION) (JAN 2024) | 46 |
| SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS | 56 |
| SECTION E - SOLICITATION PROVISIONS | 57 |
| E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (SEP 2023) | 57 |
| E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021) | 61 |
| E.3 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT ORDERS—REPRESENTATION AND DISCLOSURES (DEC 2023) | 64 |
| E.4 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018) | 65 |
| E.5 52.233-2 SERVICE OF PROTEST (SEP 2006) | 66 |
| E.6 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018) | 67 |
| E.7 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998) | 67 |
| E.8 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2023) | 71 |
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: Contracting Officer 36C24W Regional Procurement Office West (RPOW) Dr. Vinicky Ann Ervin Ph.D.
3237 Peacekeeper Way Building 200 Suite 204 McClellan Park CA 95652
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 | [] |
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.
ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:
| AMENDMENT NO |
| DATE |
B.2 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 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 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 to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.
d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.
7. LIQUIDATED DAMAGES FOR DATA BREACH
a. Consistent with the requirements of 38 U.S.C. 5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.
b. The contractor/subcontractor shall provide notice to VA of a "security incident" as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.
c. Each risk analysis shall address all relevant information concerning the data breach, including the following:
(1) Nature of the event (loss, theft, unauthorized access);
(2) Description of the event, including:
(a) date of occurrence;
(b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;
(3) Number of individuals affected or potentially affected;
(4) Names of individuals or groups affected or potentially affected;
(5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text;
(6) Amount of time the data has been out of VA control;
(7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);
(8) Known misuses of data containing sensitive personal information, if any;
(9) Assessment of the potential harm to the affected individuals;
(10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and
(11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.
d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:
(1) Notification;
(2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;
(3) Data breach analysis;
(4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;
(5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and
(6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.
8. SECURITY CONTROLS COMPLIANCE TESTING
On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-day's notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time.
9. TRAINING
a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:
(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems;
(2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;
(3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and
(4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document - e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]
b. The contractor shall provide to the contracting officer and/or the COR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.
c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.
(End of Clause) Statement of Work- Additional Omnicell XT Medicine Cabinets for VA San Diego Healthcare System SCI/CLC Building
1. Introduction The purpose of this Statement of Work (SOW) is to outline the tasks and responsibilities of the successful offeror in relation to the VA San Diego Healthcare System (VASDHS) SCI/CLC project for the installation, integration, and implementation of Omnicell XT medicine cabinets (automated dispensing cabinets).
San Diego VA Healthcare System has a requirement to purchase Medication Distribution Systems and components with an authorized vendor to supply and deliver the item(s) identified in Table 1 below. See salient characteristics below. This is brand name requirement. This requirement is to support the activation of the new SCI/CLC building. This new building has a need for eight (8) Controlled substance dispensers, 164 metal locking drawers, four (4) XT med 2-cell cabinets and four (4) XT med 3-cell cabinet inventory management systems (all 8 cabinets are equipped with a BioIDscanner, medication label and receipt printers, software license with patient profile option and software license for scheduled medications, and handheld scanner for checking medications), eight (8) XT external return bins, eight (8) windows 10 premium O/S package, eight (8) XT Flexlock with cable, eight (8) XT pull out shelves. Omnicell is the basis for design.
Table 1 – Package Items Summary
| Item # |
| Item Description |
| Part # (basis of design) |
| Quantity |
| 1 |
| XT CONTROLLED SUBSTANCE |
DISPENSER
| MED-CSD-001 |
| 8 |
| 2 |
| METAL LOCKING DRAWER |
| MED-DRW-009 |
| 164 |
| 3 |
| XT MED 2-CELL CABINET |
Solution includes:
*XT MED 2-CELL CABINET
*XT CONSOLE- BIOID, MED LBL
a. RCPT PRNTR
*SW LICENSE- PROFILE OPTION
*SW LICENSE- SCHEDULED
MEDS
*XT SCANNER, WIRED 1,2,3
CELL
| MED-FRM-102 |
| 4 |
| 4 |
| XT MED 3-CELL CABINET |
Solution includes:
*XT MED 3-CELL CABINET
*XT CONSOLE- BIOID, MED LBL
a. RCPT PRNTR
*SW LICENSE- PROFILE OPTION
*SW LICENSE- SCHEDULED
MEDS
*XT SCANNER, WIRED 1,2,3
CELL
| MED-FRM-103 |
| 4 |
| 5 |
| XT EXTERNAL RETURN BIN, |
WIRED CAB MOUNT
| MED-OPT-002 |
| 8 |
| 6 |
| WIN10 PREMIUM O/S |
PACKAGE
| MSA-LIC-009 |
| 8 |
| 7 |
| XT FLEXLOCK WITH 50 FT |
CABLE,INSTALLED
| SRD-OPT-012 |
| 8 |
| 8 |
| XT PULLOUT SHELF |
| SUP-OTH-002 |
| 8 |
1.1 Background
The VASDHS at 3350 La Jolla Village Dr, San Diego, CA 92161 is part of the Desert Pacific Healthcare Network (VISN 22), and is one of the most diversified tertiary health care providers in the VA. It is a teaching hospital, providing a full range of patient services, with state-of-the art technology as well as education and research.
2. Scope
The breakdown of the Omnicell cabinet location assignment is as follows:
| · SCI/CLC Building: Room 1A167 | XT MED 2-CELL CABINET |
| · SCI/CLC Building: Room 2A132 | XT MED 3-CELL CABINET |
| · SCI/CLC Building: Room 2B124 | XT MED 3-CELL CABINET |
| · SCI/CLC Building: Room 3A149 | XT MED 3-CELL CABINET |
| · SCI/CLC Building: Room 3B160 | XT MED 3-CELL CABINET |
| · SCI/CLC Building: Room 4A112A | XT MED 2-CELL CABINET |
| · SCI/CLC Building: Room 4B106 | XT MED 2-CELL CABINET |
| · SCI/CLC Building: Room 4B138 | XT MED 2-CELL CABINET |
3. Tasks
3.1 General Requirements
· The vendor shall submit a cost proposal with an associated project management plan addressing the tasks associated with the SOW, as described in the evaluation criteria section.
· Subtasks not specified in the SOW will be identified and include associated costs by project task, milestones and deliverable dates.
· All written deliverables must be phrased in terms and language that can be easily understood by non-technical personnel, i.e. a person without subject matter expertise.
· All document deliverables, hard copy and electronic, must be in formats as specified-at a minimum, the formats must be in industry accepted standards.
· The vendor will provide service manuals that includes theory of operation, maintenance requirements, repair information, schematics, part lists and troubleshooting information in electronic format for use by the VA IT Operations Department.
· Date of manufacture must not be greater than 2 years before the purchase order date. The equipment must not be used or refurbished and must have the latest manufacturer’s software/hardware updates installed. Any batteries provided with the unit will not be manufactured more than 12 months before the purchase order issue date.
· A kickoff meeting will be held at a location and time selected by the VASDHS where the vendor and its staff will be introduced.
· An automated dispensing system that provides controlled dispensing, inventory, and security.
· Microsoft Windows 10 loT Enterprise LTSB with BitLocker Drive Encryption and updated Intel technology enhance reliability, security, and responsiveness
· Ethernet connection for data transfer.
· Compatible with existing Omnicell Omnicenter software which allows for queries and monitoring of medication transactions that can be viewed remotely.
· Touch screen display to operate.
· Metal locking open configurable lids, drawers, cabinets and bins. Durable metal locking lids keep medications secure.
· Drawers can be added or changed on-site as clinical needs evolve.
· Glass doors.
· Adjustable shelving to hold medications of varied sizes/dimensions.
· Backup battery.
· Fingerprint BioID: biometric, positive-ID fingerprint system that offers security and quick access to the cabinet.
· Compatible with current VHASDC Automated Dispense Cabinet (ADC) system.
· Built-in UPS with surge-suppression circuitry – provides the computer with up to 20 minutes of power when voltage levels become erratic or fail.
· The vendor and/or its staff must have knowledge and expertise of the environment for which the work is to be performed.
· The vendor shall provide total system integration for each of the medication rooms listed above.
3.2 Mandatory Tasks
| · SCI/CLC Building: Room 1A167 | XT MED 2-CELL CABINET |
| · SCI/CLC Building: Room 2A132 | XT MED 3-CELL CABINET |
| · SCI/CLC Building: Room 2B124 | XT MED 3-CELL CABINET |
| · SCI/CLC Building: Room 3A149 | XT MED 3-CELL CABINET |
| · SCI/CLC Building: Room 3B160 | XT MED 3-CELL CABINET |
| · SCI/CLC Building: Room 4A112A | XT MED 2-CELL CABINET |
| · SCI/CLC Building: Room 4B106 | XT MED 2-CELL CABINET |
| · SCI/CLC Building: Room 4B138 | XT MED 2-CELL CABINET |
· The vendor and/or its staff must have knowledge and expertise of the environment for which the work is to be performed.
· The vendor shall provide total system integration for each of the medication rooms listed above.
3.2.1 Implementation/Delivery Schedule
· Site Address San Diego VA Healthcare System 3350 La Jolla Village Drive San Diego, CA 92161 – 0002
· Items shall be delivered no earlier than the estimated delivery start date and no later than the delivery end date listed in Table 2 below.
| Building Name |
| Building # and Letter |
| Estimated Delivery Start Date |
| Estimated Delivery End Date |
SCI/CLC
| 07/2024 |
| 11/2024 |
· The Above delivery schedule is based upon the current construction schedule due to the nature of activation efforts and construction timelines and dates may vary and shift. Delivery dates must be flexible. The delivery of items for installation are dependent upon the completion of applicable areas within the building. If there is a delay, the Contractor may be required to adjust the delivery date at no cost to the Government. The Contractor will coordinate with the on-site POC’s before delivery.
· The awardees actual delivery dates will be confirmed by VA upon award.
· Post-award, the vendor will coordinate delivery date identified in this document with the VA prior to beginning any work.
· The vendor shall send onsite resource(s) to assist and carryout the activation of all assets to assigned locations listed above.
· Onsite resource(s) will be fully equipped with tools and materials needed to complete the task of activating all assets.
· Delivery and receipt of the proposed items is to be directed to the location of the new SCI/CLC building of the San Diego VA Healthcare System.
· Delivery of items must be during normal business hours listed under 3.2.3 Hours of Operation.
· Labeling of delivered items shall include the VA facilities contract number and VA Purchase Order number for identification and reference upon receipt of product.
3.2.2 Change Management Plan
· The vendor shall provide a Change Management Plan to document procedures for additions, deletions, and modifications to the Scope of Work and the Mandatory Tasks as outline in section 3.2.
3.2.3 Hours of Operation
· Normal tour-of-duty hours at the VASDHS is 7:30 am to 5:00 pm, Monday through Friday, excluding Federal holidays. There may be instances in which the vendor’s workday may be outside of this period. The vendor is required to coordinate these times with the designated Program Manager.
In accordance with 5 U.S.C. 6103, Executive Order 11582 and Public Law 94-97 the following national holidays are observed and for the purpose of this contract are defined as “Legal Federal official holidays”
| New Year’s Day |
| January 1st |
| Martin Luther King’s Birthday |
| Third Monday in January |
| President’s Day |
| Last Monday in January |
| Memorial Day |
| Last Monday in January |
| Juneteenth |
| June 19th |
| Independence Day |
| July 4th |
| Labor Day |
| First Monday in September |
| Columbus Day |
| Second Monday in October |
| Veteran’s Day |
| November 11th |
| Thanksgiving Day |
| Fourth Thursday in November |
| Christmas Day |
| December 25th |
When a holiday falls on a Sunday, the following Monday will be observed as a National Holiday. When a holiday falls on a Saturday, the preceding Friday is observed as a National Holiday by U.S. Government Agencies.
3.2.4 Acceptance/Period of Performance
· Upon completion of installation, the VASDHS shall monitor and verify the equipment and installation during operations as outlined by the manufacturer for a total of six (6), contiguous, consecutive, uninterrupted business weeks. This period of 6 weeks shall be the acceptance phase of the installation. The vendor is required to supply the VASDHS with an acceptance form to be signed off at the end of the acceptance phase to indicate possession of the installation and equipment and to inform the Contracting Office to proceed with payment(s) as outlined in the Purchase Order.
· Any problems with the system must be isolated and repaired by the vendor during the acceptance period. The vendor will troubleshoot the hardware, software, and communications/ancillary equipment to determine the best method of repair. The vendor shall provide brief descriptive resolution of all maintenance. Please note that any problems with the system during the acceptance phase will result in a reset of the acceptance phase, resulting in a new 3-week acceptance phase as outlined above.
· The vendor and the VASDHS shall jointly cooperate in the development and implementation of a Quality Assurance Plan (QAP). The QAP shall document the process that will verify and validate quality assurance in compliance with the requirements and ensure these requirements meet the VASDHS’s expectations.
· The vendor shall develop the QAP based on accepted industry standards such as the CMMI SM, ISO 9000, IEEE 12207, or other accepted industry QA standards. The QAP shall detail the processes, procedures, and metrics for assuring quality. The QAP shall also include, at a minimum, a description of the following key activities:
· Establishment of capable processes.
· Development and implementation of procedures to identify, prevent, and ensure non-recurrence of defective services.
· Establishment of mechanisms for feedback of performance.
· Monitoring and control of critical processes.
· Establishment of a designated point of contact (POC) to serve as the POC for quality control issues/complaints.
· Establishment of reliable methods of record keeping and documentation of all corrective actions and process improvements undertaken during the acceptance period
4. Vendor Responsibilities
· The vendor must manage and coordinate installation at San Diego VA Healthcare System with the COR (Thanh-Lan Ha) or her representative (Alison Truong).
· The vendor must state a need for staging area to accommodate item assembly and installation, if needed. Post-award this information will be confirmed with the vendor.
· The vendor shall be responsible for any and all liability actions or suits when the vendor is at fault or negligent in the performance of installation and testing activities. Pecuniary liability is also included for any and all damages to VA buildings and equipment caused by installation activities. The vendor shall comply with all local building and fire codes in addition to VA policy and procedures at the site.
· The vendor shall operate under, but not limited, to the following national codes, telecommunications industry standards and practices: National Electric Code (NEC), Building Industry Consulting Service International (BICSI), all standards, Electronic Industries Association/Telecommunications Industry Association EIA/TIA, Americans with Disabilities Act (ADA), National Fire Protection Association (NFPA), Underwriters Laboratories (UL), ITU and IETF and all applicable audio, video, communication, data and control standards.
5. VASDHS…
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