36C25025Q0145.docx

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DA10--Alaris Software Management Service Indianapolis, IN
Solicitation number
36C25025Q0145
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This is a Request for Quote (RFQ) seeking software management services for the existing Alaris Infusion System at the Richard L. Roudebush VA Medical Center in Indianapolis. The contractor must provide software maintenance, updates, training, and support services for various Alaris infusion pump components including syringe modules, pump modules, PC units, PCA modules, and ETCO2 modules, along with associated server and software systems like Guardrails Suite MX and CQI Reporter.

The RFQ was issued under FAR Part 13 with NAICS code 541511 and a size standard of $34 million. Questions are due by January 7, 2025 at 12:00 PM EDT, with quotes due January 10, 2025 at 4:30 PM EST. The period of performance is a base year from January 13, 2025 to January 12, 2026 with no option years. Key requirements include providing software updates, patches, clinical training, 24/7 technical support with 2-hour response times, data analytics, and documentation. The contractor must maintain HIPAA compliance and execute a Business Associate Agreement. This appears to be a bridge contract while the VA develops an acquisition strategy for a replacement infusion system.

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Appendix D- Rules of Behavior.pdf PDF

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36C25025Q0145 A.1 VAAR 852.239-75 INFORMATION AND COMMUNICATION TECHNOLOGY ACCESSIBILITY NOTICE (FEB 2023)

(a) Any offeror responding to this solicitation must comply with established VA Information and Communication Technology (ICT) (formerly Electronic and Information (EIT)) accessibility standards. Information about Section 508 is available at http://www.section508.va.gov/.

(b) The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 852.239–75, Information and Communication Technology Accessibility. In order to facilitate the Government’s determination whether proposed ICT supplies meet applicable Section 508 accessibility standards, offerors must submit appropriate VA Section 508 Checklists, in accordance with the checklist completion instructions. The purpose of the checklists is to assist VA acquisition and program officials in determining whether proposed ICT supplies, or information, documentation and services conform to applicable Section 508 accessibility standards. The checklists allow offerors or developers to self-evaluate their supplies and document—in detail—whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues.

(c) Respondents to this solicitation must identify any exception to Section 508 requirements. If an offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the described accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(End of Provision)

A.2 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (OCT 2019)

(a) The offeror agrees, if awarded a contract, to use the service-disabled veteran-owned small businesses (SDVOSBs) or veteran-owned small businesses (VOSBs) proposed as subcontractors in accordance with 852.215–70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors, or to substitute one or more SDVOSBs or VOSBs for subcontract work of the same or similar value.

(b) Pursuant to 38 U.S.C. 8127(g), any business concern that is determined by VA to have willfully and intentionally misrepresented a company’s SDVOSB/VOSB status is subject to debarment for a period of not less than five years. This includes the debarment of all principals in the business.

(End of Clause)

A.3 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

The Contractor shall not make reference in its commercial advertising to Department of Veterans Affairs contracts in a manner that states or implies the Department of Veterans Affairs approves or endorses the Contractor’s products or services or considers the Contractor’s products or services superior to other products or services.

(End of Clause)

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

583-25-1-169-0028 36C25025Q0145 01-03-2025 Thompson, Margaret R.

614-257-5869 01-10-2025 16:30

EST

Department of Veterans Affairs Columbus Chalmers P. Wylie Ambulatory Care Center 420 North James Road Columbus

OH

43219-1834 X 541511 $34 Million N/A X Department of Veterans Affairs Columbus Chalmers P. Wylie Ambulatory Care Center 420 North James Road Columbus

OH

43219-1834 Department of Veterans Affairs Columbus Chalmers P. Wylie Outpatient Clinic 420 North James Road Columbus

OH

43219-1834

36C250 Department of Veterans Affairs Financial Services Center Invoices to be Submitted Electronically www.ob10.com/us/en/veterans-affairs// e-Invoice Setup Info Phone 877-489-6135

877-353-9791 512-460-5429 X See CONTINUATION Page This is a requirement to provide software management services for the existing Alaris Infusion System installed at the Indianapolis VAMC while the VAMC develops its acquisition strategy for a replacement infusion system.

Vendor shall provide all personnel, management, and maintenance necessary to provide Carefusion Alaris Infusion Pump Software Management Services for the Indianapolis VAMC IAW the PWS herein.

Vendor shall be issued a Firm-Fixed-Price Purchase Order for a base plus zero (0) option years.

All questions relating to this RFQ must be submitted by email only to margaret.thompson@va.gov. Question deadline is January 7, 2025 at 12:00 PM NOON EDT.

This procurement is being conducted under FAR 13.106.

See CONTINUATION Page 583-3650160-169-825500-2520 010020190 X X One(1) Andrea J. Roach Contracting Officer Table of Contents

A.1 VAAR 852.239-75 INFORMATION AND COMMUNICATION TECHNOLOGY ACCESSIBILITY NOTICE (FEB 2023)1
A.2 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (OCT 2019)1
A.3 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)1
SECTION A2
A.4 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES2
SECTION B - CONTINUATION OF SF 1449 BLOCKS5
B.1 CONTRACT ADMINISTRATION DATA5
B.2 REVIEW REQUIRED REGISTRATION WITH CONTRACTOR PERFORMANCE ASSESSMENT SYSTEM (CPARS)6
RECORDS MANAGEMENT LANGUAGE FOR CONTRACTS7
B.3 INFORMATION SECURITY IN ACCORDANCE WITH VA HANDBOOK 6500.6 Appendix C – Paragraphs 1,2,3,6,7,9:8
B.4 PRICE/COST SCHEDULE12
ITEM INFORMATION12
1.BACKGROUND13
2.SCOPE OF WORK14
2.1Information Security Considerations14
3.DELIVERABLES14
3.1Training15
3.2Support15
3.3Data & Analytics16
3.4Software Updates & Maintenance16
Unscheduled Maintenance (Emergency Repair Service)17
Scheduled Maintenance17
3.5Documentation & Reports18
3.6Payments19
3.7Competency and Certification of Personnel Servicing Equipment19
4.PERFORMANCE STANDARDS19
5.PERFORMANCE PERIOD21
6.PLACE OF PERFORMANCE22
7.REFERENCES22
SECTION C - CONTRACT CLAUSES23
C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)23
C.2 VAAR 852.204-71 INFORMATION AND INFORMATION SYSTEMS SECURITY (FEB 2023)29
C.3 VAAR 852.211-76 LIQUIDATED DAMAGES – REIMBURSEMENT FOR DATA BREACH COSTS (FEB 2023) ALTERNATE I (FEB 2023)38
C.4 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)39
C.5 VAAR 852.237-75 KEY PERSONNEL (OCT 2019)40
C.6 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)40
C.7 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)40
C.8 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC 2022)41
C.9 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-OWNED SMALL BUSINESS EVALUATION FACTORS (JAN 2023) (DEVIATION)41
C.10 VAAR 852.239-70 SECURITY REQUIREMENTS FOR INFORMATION TECHNOLOGY RESOURCES (FEB 2023)42
C.11 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2024)44
SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS53
D.1 QUALITY ASSURANCE SURVEILLANCE PLAN54
Technical support for Emergency Repair Service57
Documentation & Reports57
BUSINESS ASSOCIATE AGREEMENT BETWEEN THE DEPARTMENT OF VETERANS AFFAIRS VETERANS HEALTH ADMINISTRATION, Richard L. Roudebush VA Medical Center, AND59
SECTION E - SOLICITATION PROVISIONS65
E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (SEP 2023)65
E.2 INSTRUCTIONS TO OFFERORS QUOTATION SUBMISSION INFORMATION AND EVALUATION CRITERIA69
E.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)73
E.4 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT ORDERS—REPRESENTATION AND DISCLOSURES (DEC 2023)75
E.5 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)77
E.6 VAAR 852.239-71 INFORMATION SYSTEM SECURITY PLAN AND ACCREDITATION (FEB 2023)77
?.## 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024)79

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 36C250 Margaret Thompson Department of Veterans Affairs Columbus Chalmers P. Wylie Ambulatory Care Center 420 North James Road Columbus OH 43219-1834

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
[X]
52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly[]
b. Semi-Annually[]
c. Other[X] Monthly in arrears

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.

https://www.tungsten-network.com/customer-campaigns/veteransaffairs/

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO
DATE

B.2 REVIEW REQUIRED REGISTRATION WITH CONTRACTOR PERFORMANCE ASSESSMENT SYSTEM (CPARS)

(a) as prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs (VA) evaluates contractor past performance on all contracts that exceed $250,000 and shares those evaluations with other Federal Government contract specialists and procurement officials. The FAR requires that the contractor be provided an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement VA uses an online database, CPARS, which is maintained by the Naval Seal Logistics Center in Portsmouth, Virginia. CPARS has connectivity with the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal agencies. PPIRS is the system used to collect and retrieve performance assessment reports used in source selection determinations and completed CPARS report cards transferred to PPIRS. CPARS also includes access to the federal awardee performance and integrity information system (FAPIIS). FAPIIS is a web-enabled application accessed via CPARS for contractor responsibility determination information.

(b) Each contractor whose contract award is estimated to exceed $250,000 is required to register with CPARS database at the following web address: www.cpars.csd.disa.mil. Help in registering can be obtained by contacting Customer Support Desk @ DSN: 684-1690 or COMM: 207-438-1690. Registration should occur no later than thirty days after contract award and must be kept current should there be any change to the contractor’s registered representative.

(c) For contracts with a period of one year or less, the contracting officer will perform a single evaluation when the contract is complete. For contracts exceeding one year, the contracting officer will evaluate the contractor’s performance annually. Interim reports will be filed each year until the last year of the contract, when the final report will be completed. The report shall be assigned in CPARS to the contractor’s designated representative for comment. The contractor representative will have thirty days to submit any comments and re-assign the report to the VA contracting officer.

(d) Failure to have a current registration in the CPARS database, or to re-assign the report to the VA contracting officer within those thirty days, will result in the Government’s evaluation being placed on file in the database with a statement that the contractor failed to respond.”

RECORDS MANAGEMENT LANGUAGE FOR CONTRACTS

The following standard items relate to records generated in executing the contract and should be included in a typical Electronic Information Systems (EIS) procurement contract:

1. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

2. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

4. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

6. The Government Agency owns the rights to all data/records produced as part of this contract.

7. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

8. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

9. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

10. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

B.3 INFORMATION SECURITY IN ACCORDANCE WITH VA HANDBOOK 6500.6 Appendix C – Paragraphs 1,2,3,6,7,9:

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. INTENTIONALLY LEFT BLANK

5. INTENTIONALLY LEFT BLANK

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 $37.00 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. INTENTIONALLY LEFT BLANK

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.

B.4 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM NUMBER
DESCRIPTION OF SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
1.00
EA
__________________
__________________

Alaris Software Support Program for updated BD AlarisTM Infusion System with software V12.3 Contract Period: Base POP Begin: 01-13-2025 POP End: 01-12-2026 PRINCIPAL NAICS CODE: 541511 - Custom Computer Programming Services PRODUCT/SERVICE CODE: DA10 - IT and Telecom - Business Application/Application Development Software As A Service

GRAND TOTAL
__________________

SOFTWARE MANAGEMENT SERVICES

PERFORMANCE WORK STATEMENT

The purpose of this procurement is to acquire infusion pump software management services (SMS) for use in Richard L. Roudebush VA Medical Center, Veteran Health Indiana, VISN 10. The Contractor shall provide all software management services required to maintain and operate the Alaris Infusion System from BD (formerly CareFusion) currently located at the Richard L. Roudebush VA Medical Center.

1. BACKGROUND

Software management services for the Alaris Infusion System includes software enhancements to server-based Alaris Infusion System software components; services that include internet, webinar and on-site training and clinical education; support ranging from remote monitoring of the Alaris Systems Manager to technical support for the Alaris Infusion System; and includes collection of data and providing analytics tools and services. Software enhancements do not include software updates or version upgrades to infusion device hardware.

The following components comprise the Alaris Infusion System located at the Richard L. Roudebush VA Medical Center for this requirement.

Table 1. Alaris Infusion System Components

VA Medical Device Nomenclature System (VAMDNS) Category
Model
INFUSION PUMPS: MULTITHERAPY: SYRINGE
ALARIS SYR MODULE 8110
INFUSION PUMPS: MULTITHERAPY
ALARIS PUMP MODULE 8100
INFUSION CONTROLLERS
ALARIS PC UNIT 8015
INFUSION PUMPS: ANALGESIC: PATIENT-CONTROLLED
ALARIS PCA MODULE 8120
MONITORS: PHYSIO: EXHALED CO2: BEDSIDE/INTRAOP
ALARIS ETCO2 MODULE 8300
NETWORKED SERVERS: MEDICAL
Alaris Systems Manager; BD Care Coordination Engine
SOFTWARE: MEDICAL
Guardrails Suite MX; Guardrails Editor; CQI Reporter; Alaris System Maintenance

Alaris Infusion System Description. Infusion system modules connect to an infusion controller (PCU). The PCU connects wirelessly to the VA enterprise network to transmit and receive data to and from the Alaris Systems Manager server. The Alaris Systems Manager resides on a server (virtual or physical) in a VA data center. Users will access the Alaris Systems Manager server to manage system configuration, retrieve pump connectivity data, capture data analytics, and upload infusion drug libraries. Users will also access software applications such as Guardrails Editor and CQI Reporter to manage drug library configuration and analyze reports collected from infusion data. Care Coordination Engines run on another server (virtual or physical) residing in a VA data center that allow for the infusion devices to wirelessly communicate interoperability parameters to the EHR. The Alaris System Maintenance software is utilized during performance of Alaris Infusion System maintenance.

The Contractor shall provide the SMS required under this contract for the following Alaris Infusion System equipment covered under this contract. All services performed shall support compatibility with the current infusion equipment.

Table 2. Supported Alaris Equipment and Software

Facility Name
Server/Application Name
Operating System/Version
Richard L. Roudebush VA Medical Center
Guardrails Suite MX; Guardrails Editor; CQI Reporter; Alaris System Maintenance
Windows Server 2012 R2, 12.0.2
Richard L. Roudebush VA Medical Center
ALARIS SYRINGE MODULE 8110
8110
Richard L. Roudebush VA Medical Center
ALARIS PUMP MODULE 8100
8100
Richard L. Roudebush VA Medical Center
ALARIS PC UNIT 8015
8015
Richard L. Roudebush VA Medical Center
ALARIS PCA MODULE 8120
8120

1. SCOPE OF WORK

The Contractor shall provide software management services for the Alaris Infusion System server and software components identified in Table 2 above. The services shall be in accordance with the tasks and deliverables as described in this Performance Work Statement (PWS). For those components of the system subject to software updates, the Contractor shall complete all system enhancements and patching with clear communication and preparation. The Contractor shall communicate all enhancements and support activations required to keep the system running effectively to the primary point of contact (POC) or the contracting officer representative (COR). All maintenance and updates shall be scheduled at least three (3) days in advance with the COR.

1. Information Security Considerations All VA sensitive information shall be protected at all times, in accordance with VA Local site guidelines. The Contractor shall report any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information to the COR.

1. Any wireless connectivity to the VA network must be compatible with 802.11b/g/n and FIPS 140-2 compliant.

1. Any remote service support requires a Memorandum of Understanding/Interconnection Security Agreement (MOU/ISA) with the VA.

1. DELIVERABLES

The Contractor shall perform/provide the following services:

2. Training

1. The Contractor shall include on-site nursing clinical support training for practice reinforcement that can be used for compliance rounds and hospital best practices.

0. One time during the base year of the contract period and any subsequent option year, the Contractor must provide one eight (8) hour day of on-site clinical consulting at each facility for every 500 infusion devices installed at that facility. The training must include nursing staff interactions with the devices and recommending improved practices for medication safety. The COR will provide the Contractor with requested training dates for each facility during the base year of the contract and any subsequent option year. The Contractor will work with the COR in good faith to reasonably accommodate the requested training dates.

0. The Contractor shall provide a written report to each facility for each practice reinforcement visit.

1. The Contractor shall include a workshop with clinical peers to support customer adoption of CQI Reporter software and enhance interpretation skills of CQI data.

0. Workshop shall be for a period of 2 days and hosted by the Contractor at the Richard L. Roudebush VA Medical Center once during the base year of the contract and each subsequent option year (annually). The COR will provide the Contractor with requested workshop dates for each facility during the base year of the contract and any subsequent option year. The Contractor will work with the COR in good faith to reasonably accommodate the requested workshop dates.

0. Workshop shall cover defining and creating a systematic approach to analyzing Guardrails Reporter software alerts and refine drug libraries, dose limits, and clinical advisories to achieve maximum impact for the organization.

1. The Contractor shall provide access to online education. Video content must be made available, upon request, to VA education staff and allowed to be uploaded by the VA to internal learning management systems.

1. The Contractor shall include Suite training sessions with clinical peers to refresh skills on the use of CQI Reporter and Editor training. The training sessions shall be available monthly and can be used as needed.

1. The Contractor shall provide tuition annually for up to two (2) VA representatives to attend the System Data Workshop.

2. Support

1. The Contractor shall provide phone or email access to highly qualified Pharmacy Consultants and Clinical Infusion Data Consultants to address customer data set questions and concerns and assist with the interpretation of CQI data. The Contractor shall provide a resolution turnaround time of 48 hours from the initial phone call or email communicating a customer issue.

0. The Contractor shall provide access to qualified Pharmacy Consultants who hold the RPh credential and have at least 3 years’ experience working with BD Continuous Quality Improvement (CQI) information to make recommendations for improved safety limits on specific pharmaceutical products.

0. The Contractor shall provide access to Clinical Infusion Data Consultants (formerly CQI Managers) who must have at least 3 years’ experience working with BD CQI information to make recommendations for improved safety limits on specific pharmaceutical products and other data set parameters.

1. The Contractor shall provide live technical telephone support with BD authorized support professionals who are based in the United States. The team must be ready to assist and provide support for equipment covered in this contract from 8:00am to 5:00pm in the local facility time zone (EST), Monday through Friday.

1. The Contractor shall provide Clinical Infusion Data Consultant data support via phone or email from 8:00am to 5:00pm in the local facility time zone (EST), Monday through Friday, for questions related to the use of the software and interpretation, review, and consulting of data.

2. Data & Analytics

1. The Contractor shall provide real-time monitoring of the Alaris Systems Manager to ensure system uptime, functionality, optimization, and health in accordance with the national MOU/ISA between the Contractor and VA which is made part of this contract and is incorporated by reference herein.

1. The Contractor shall provide concise, actionable information on the hospital’s infusion management practices, without requiring analytical or reporting software installation or in-house technical resources. This includes unlimited access to a web-based portal defined by hospital with benchmarking tools and the ability to view all infusions. The Government can request a quarterly phone call or report with the data analyst to review the findings in this report.

1. The Contractor shall provide benchmarking tools and the ability to view all infusions (not just those outside of prescribed ranges). This information must be web-based and be accessible to an unlimited number of users per hospital. These services would require hosting on a vendor platform but must not contain any sensitive information, in accordance with the national MOU/ISA.

2. Software Updates & Maintenance If the Contractor releases updates to the applications or server identified in Table 2 to enhance the security or operation of the software, the Contractor shall deliver the enhancement to the Government in machine-readable form with instructions to assist the Government with installing the enhancement. These enhancements will be provided to the Government within 60 days of their issuance or data of first commercial availability, with no additional charge to the Government, for installed instances of the software. As applicable, the Contractor will install updates remotely through the Contractor’s remote access solution. The Contractor shall use commercially reasonable efforts to correct errors in the software that materially affect the functionality of the software.

All labor, time, materials, equipment, travel, service manuals, and supplies necessary to provide the services required under this contract shall be included in the contract price. One time during each annual period, the Contractor will perform one (1) on-site technical service visit for up to eight (8) hours for each 80 PC units to download CQI data and upload the Government’s drug library data set onto the licensed units. The Contractor shall provide telephone support to the Government regarding the operation of and potential errors in the software.

1. The Contractor shall provide enhancements to the Guardrails Suite MX and Guardrails Editor software when commercially available. This includes providing any updates to the Alaris Systems Manager that are required to install the newest version of Suite MX software.

1. The Contractor shall provide Alaris Systems Manager service patch management of the operating system, Systems Manager application, and other software components. The Contractor shall provide rigorous testing before deployment of software patches and updates, including customized patch cycles and notifications options. All software patches and updates shall be provided at no additional cost to the Government. Remote management of the server shall be delivered in accordance with the most current version of the national MOU/ISA between VA and the Contractor.

1. The Contractor shall provide CareFusion Coordination Engine (CCE) service patch management of the operating system, CCE application, and other software components. The Contractor shall provide rigorous testing before deployment of software patches and updates, including customized patch cycles and notifications options. All software patches and updates shall be provided at no additional cost to the Government. Remote management of the server shall be delivered in accordance with the most current version of the national MOU/ISA between VA and the Contractor.

1. The Contractor shall provide remote installation of server system patches, including the operating system, Alaris Systems Manager, and other system components which will be patched regularly.

1. Software update/enhancement installations shall normally be scheduled and performed outside normal business hours, 8:00am to 5:00pm in the local time zone (EST) Monday through Friday, of coverage at no additional charge to the Government. The COR may approve software installations outside of these hours to meet facility needs.

Unscheduled Maintenance (Emergency Repair Service)

1. The Contractor’s Field Service Engineer (FSE) shall respond via phone call to the COR or his/her designee immediately after receipt of telephoned emergency repair service notification twenty-four (24) hours per day. If the problem cannot be corrected by phone, the FSE will commence work (on-site or remote desktop response) within two (2) hours after receipt of the notification and will proceed progressively to completion without undue delay. This requirement for response time shall be the same for both service calls during the VA normal business hours and after-hour service calls. The COR will provide the Contractor with (a) an accurate description of the software error; (b) the steps necessary to reproduce the software error, if available; (c) if required, the data being processed at the time of the software error and associated log files; and (d) the severity of the software error, including the circumstances that lead to the software error. The COR and the Contractor will communicate and mutually agree on the severity level of the software error in writing.

Scheduled Maintenance

1. The Contractor shall perform patches and enhancements to the software components identified in Table 2 to ensure the Alaris Infusion System equipment and software perform in accordance with the latest OEM maintenance procedures and protocols. Patching shall be provided for all environments: pre-production, production, and training environments. Scheduled software maintenance shall be scheduled at least three (3) days in advance with the COR. An outline of the scheduled software maintenance procedures shall be provided to the COR. The Contractor shall provide and utilize procedures and checklists with worksheet originals indicating work performed, as applicable. This documentation shall be provided to the COR at the completion of the scheduled software maintenance. The Contractor shall provide written description of scheduled software maintenance. This description shall include an itemized list of the procedures performed.

1. Scheduled software maintenance services shall include, but need not be limited to, the following:

0. Reviewing operating system software diagnostics to ensure that the system is operating in accordance with the manufacturer’s specifications

0. Performing remedial software maintenance of non-emergent nature

0. Returning the equipment to the operating condition, per OEM standards

0. Providing documentation of services performed

1. The Contractor shall perform scheduled maintenance services from 8:00am to 5:00pm in the local facility time zone (EST), Monday through Friday. All exceptions to the scheduled software maintenance schedule shall be arranged and approved in advance with the COR.

2. Documentation & Reports The Contractor shall provide written reports detailing the software management services provided under the contract. The documentation shall include detailed descriptions of the scheduled and unscheduled software maintenance (i.e., emergency software repairs (ESR)) procedures performed, including updates and services required to maintain the software. The ESR shall consist of a separate report for the item(s) covered under this contract.

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