RFI - Omnicell Cabinets - Draft SOW.pdf

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Omnicell Medication Dispensing Cabinets
Solicitation number
VA2600044494
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This is a draft Statement of Work for the procurement of Omnicell XT Two Cell Medication Dispensing Cabinets for the Charles George VA Medical Center (CGVAMC) in support of expanded Hospice and Chronic Long Care (CLC) services. The contractor must deliver a turn-key solution including three Omnicell XT Two Cell Cabinet systems (MED-FRM-502) that integrate seamlessly with existing Omnicell infrastructure, services, licenses, and software already operational at CGVAMC. The anticipated deliverables include 24 open configurable drawers, 24 metal locking drawers, 3 external return bins with wired cabinet mount, 3 premium Win10 packages with 120-month subscription terms, 4 SinglePointe units, and 3 wireless FlexLock units. The contractor bears full responsibility for project management, labor, equipment, materials, travel, configuration, manufacturer-required testing, remote and on-site installation support, calibration, coordination with on-site OI&T and Biomedical Technicians, wireless FlexLock installation, license support, and all setup deemed necessary for the expansion project. Acceptance is contingent upon delivery and installation of a fully operational and complete system with no partial acceptance or incremental invoicing anticipated.

The contractor must comply with comprehensive security and personnel requirements, including background investigations for all employees requiring access to VA computer systems (Minimum Background Investigation level, Low Risk position sensitivity). All contractor personnel must maintain U.S. citizenship and English language proficiency, submit required security forms (SF 86, SF 85P variants, FD 258, VA Form 0710) within 30 days, and complete mandatory training including VA Cyber Security Awareness, privacy training, and Compliance Awareness Training (TMS course #43790) within 90 days of hire and annually thereafter. The SOW incorporates extensive VA security clauses addressing information custodial requirements, encryption standards (FIPS 140-2 validated minimum), firewall compliance, data destruction protocols per NARA standards, and incident reporting obligations. Contractors are liable for liquidated damages of $37.50 per affected individual in the event of a data breach involving sensitive personal information, covering one year of credit monitoring, fraud resolution services, identity theft insurance ($20,000 coverage), and related legal expenses. The document notes this is a draft SOW for market research purposes only.

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STATEMENT OF WORK

for

Omnicell XT Two Cell Medication Dispensing Cabinets for CLC and Hospice

1.0 SUMMARY OF REQUIREMENT

Charles George VA Medical Center Pharmacy and Nursing Services have increased patient access in Hospice and CLC and need (3) additional Omnicell XT Two Cell Medication Dispensing Cabinets for controlled substance and non-controlled substance dispensing. The additions will require Omnicell cabinets to tie into existing Omnicell services, license, software, and systems already in place within the Charles George VA Medical Center

(CGVAMC).

2.0 SCOPE

The Contractor shall be required to deliver a turn-key solution to expand its existing Omnicell capabilities into the CLC and Hospice to include but not limited to, project management, labor, equipment, materials, travel and any incidentals required to satisfy the requirements of this Statement of Work. The Contractor shall also be responsible for timely delivery, training, and phased site deployment to ensure the successful completion of the tasks as outlined in this Statement of Work.

3.0 DESCRIPTION OF WORK

The Contractor shall be required to furnish all items, to include but not limited to, project management, labor, equipment, materials, travel and any incidentals required to deliver turn-key solution to expand its existing Omnicell capabilities into in Hospice and CLC. The site solution shall deploy a seamlessly integrated Omnicell XT Two Cell Medication Dispensing Cabinets to Hospice and CLC.

3.1 ANTICIPATED DELIVERABLES:

The Government anticipates that the equipment listed below should satisfy the minimum needs of the Government. However, it is the contractor’s responsibility to ensure that the solution proposed in any configuration of equipment shall meet or exceed the minimum capabilities sought. (Omnicell Brand Only)

Item Description Quantity

Draft Statement of Work for Omnicell XT Two Cell Medication Dispensing Cabinets for CLC and Hospice

This is a draft Statement of Work for Market Research purposes only

3.2 INSTALLATION

3.2.1 The contractor shall be responsible for providing installation service for the offered site solution to include but not limited to, Configuration, Manufacturer required testing, remote installation support, on-site installation support, on-site calibration, on-site testing.

3.2.2 The contractor shall be responsible for coordination with on-site OI&T and Biomedical Technicians to ensure that data points, ports, and settings are navigable and operable.

3.2.3 The contractor shall be responsible for the implementation of cabinet configuration, wireless flex lock installation, license support, data and biomedical coordination, interface security, and any further set-up and installation of items deemed necessary to the expansion project.

4.0 INSPECTION AND ACCEPTANCE

4.1 Acceptance shall only take place at the time when a fully operational and complete system has been delivered and installed. The Government does not anticipate that project phasing for partial acceptance and incremental invoicing is required for this project.

5.0 CONTRACTOR PERSONNEL SECURITY REQUIREMENTS (where applicable)0F

All contractor employees who require access to the Department of Veterans Affairs’ computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Office of Security and Law Enforcement prior to contract performance. This requirement is applicable to subcontractor personnel requiring the same access.

1. Position Sensitivity – The position sensitivity has been designated as Low Risk.

2. Background Investigation – The level of background investigation commensurate with the required level of access is Minimum Background Investigation.

3. Contractor Responsibilities

a. The contractor shall prescribe all personnel requiring access to the computer systems to ensure they maintain a U.S. citizenship, and can read, write, speak and understand the English language.

b. The contractor shall submit or have their employees submit the required forms (SF 86 or SF 85P, SF 85P-S, FD 258, Contractor Fingerprint Chart, VA Form 0710, Authority for Release of

Information Form, and Optional Forms 306 and 612) to the VA Office of Security and Law Enforcement within 30 days of receipt.

c. The contractor, when notified of an unfavorable determination by the Government, shall withdraw the affected employee from working under the contract.

d. Failure to comply with contractor personnel security requirements may result in termination of the contract for default.

4. Government Responsibilities

1 This language is still in draft form.

a. The VA Office of Security and Law Enforcement will provide the necessary forms to the contractor, or to the contractor’s employees, after receiving a list of names and addresses.

b. Upon receipt, the VA Office of Security and Law Enforcement will review completed forms for accuracy and forward the forms to the office of Personnel Management (OPM) to conduct background investigations.

c. The VA Office of Security and Law Enforcement will notify the CO, and contractor, of adjudication results received from OMB.

d. Upon being notified about a favorable determination, the CO may issue a notice to proceed to the contractor.

6. SECURITY CLAUSE(S)

SECTION 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.

SECTION 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. 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 employment. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

SECTION 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. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor during 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.

c. 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.

d. 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.

e. 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.

f. 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.

g. 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.

h. 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.

i. 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 to such court orders or other requests to the VA contracting officer for response.

j. For service that involves 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 COTR.

SECTION 4: INFORMATION SYSTEM DESIGN AND DEVELOPMENT

a. 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.

b. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges.

c. 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.

SECTION 5: INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

a. 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.

SECTION 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 COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitivity 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.

SECTION 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 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 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 $37.50 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.

SECTION 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 days’ 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.

SECTION 9: TRAINING

a. All contractor employees and subcontractor employees require 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.]

a. The contractor shall provide the contracting officer and/or the COTR with 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.

b. 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.

7. COMPLIANCE

Compliance Awareness Training TMS course #43790 shall be completed by the contractor prior to access to any facility systems within VISN 6. The class is required within 90 days of hire and annually thereafter, with a test out option. The vendor has responsibility for “Duty to Report” any fraud, waste and abuse witnessed while on VA premises to the Integrity and Compliance Officer.

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