About this file

This is a solicitation for a Cardiac (Telemetry and Bedside Monitoring) Documentation and Reporting Digital Solution for nine VA Medical Centers in Veterans Integrated Service Network 12. The solicitation seeks a contractor-agnostic solution that integrates with patient monitoring networks and the VA's electronic health record systems. Required products and services include a digital solution for documenting ECG waveform strips, integrating the strips into VA's current and future EHRs, software maintenance and support, and training. The base period of performance is from September 2023 through August 2024 with four one-year option periods extending to August 2028. Pricing is fixed for annual software, maintenance and support for each medical center location. Responses are due by July 2023 with award by September 2023. The solicitation is set aside for SDVOSBs and includes SDVOSB representation, agreement, and subcontracting requirements.

View the file

Other files

On GovTribe

Work with this file

  • Download the original file
  • Contacts named in this file
  • Similar government files
  • Ask GovTribe AI about this file

Text version

36C25223Q0580

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)

c. 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

None 695-23-2-133-2037 Effective:

36C25223Q0580 07-19-2023 Joni Dorr 414-844-4858 08-07-2023 10:00

CST

Department of Veterans Affairs

GLAC (69D)

115 South 84th Street, Suite 101 Milwaukee WI 53214-1476 X 334510 1250 Employees N/A X VISN 12 VA Medical Centers See Section B.4 for Addresses

Department of Veterans Affairs

GLAC-MILWAUKEE (69D)

Great Lakes Acquisition Center - HC South 84th Street, Suite 101 Milwaukee WI 53214-1476

Department of Veterans Affairs Financial Services Center PO Box 149971 Austin TX 78714-9971 See CONTINUATION Page Cardiac (Telemetry and Bedside Monitoring) Documentation and Reporting Digital Solution for VISN 12 VA Medical Centers which consists of Edward Hines Jr. VA Hospital located in Hines, IL; Captain James A. Lovell Federal Health Care Center (FHCC) located in North Chicago, IL; VA Illiana Health Care System located in Danville, IL; Jesse Brown VA Medical Center located in Chicago, IL; Clement J. Zablocki VA Medical Center located in Milwaukee, WI; William S.

Middleton Memorial Veterans Hospital located in Madison, WI; Oscar G. Johnson VA Medical Center located in Iron Mountain, MI; Tomah VA Medical Center located in Tomah, WI;

and Milo C. Huemp fner VA Out Patient Clinic (CBOC) located in Green Bay, WI. Purchase order shall be for a base year and four (4) one-year options. Base Year tentative period of performance is 09/01/2023-08/31/2024 with an ultimate completion date of 08/31/2028.

See continuation page $0.00 See CONTINUATION Page 695-3630160-133-825500-3131 0100555Y1 X X X one Ashley Johnson Contracting Officer

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 PURCHASE ORDER ADMINISTRATION DATA (continuation from Standard Form 1449)

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

AMENDMENT NODATE
________________________________________________________
________________________________________________________
________________________________________________________

1. PURCHASE ORDER ADMINISTRATION: All purchase order administration matters will be handled by the following individuals:

a. CONTRACTOR:

Contractor Name:_________________________________________
Address:_________________________________________
City-State-Zip:_________________________________________
Point of Contact/Title:_________________________________________
Phone Number:_________________________________________
Fax Number:_________________________________________

E-Mail Address:_________________________________________

UEI Number:_________________________________________
DUNS Number:_________________________________________

Contractor’s past performance point of contact (if different than above):

Name:_________________________________________
Email Address:_________________________________________

b. GOVERNMENT: Joni Dorr, Contract Specialist Contracting Office Code: 36C252

Department of Veterans Affairs
Great Lakes Acquisition Contracting
115 S. 84th St., Ste 100

Milwaukee, Wi 53214 joni.dorr@va.gov

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

a. FAR 52.232-33 PAYMENT BY ELECTRONIC FUNDS TRANSFER – SYSTEM FOR AWARD MANAGEMENT (OCT 2018)

3. INVOICES:

a. Invoices shall be submitted in arrears in accordance with: 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)

b. Payments shall be made in arrears upon receipt of a properly prepared invoice.

c. The VA has mandated electronic invoice submission to the Veterans Affairs Financial Services Center (VAFSC). VAFSC has partnered with Tungsten Network e-Invoicing network, for submissions of all electronic invoices to VA. Tungsten Network electronic invoicing is free to all VA vendors. In order to submit electronic invoices, all VA vendors must register with Tungsten Network by submitting an email to VA.Registration@Tungsten-Network.com or calling 1-877-489-6135 for Enrollment.

d. Contractor shall submit an electronic invoice by the tenth (10th) of the following month services were performed to the Veterans Affairs Financial Services Center (VAFSC) e-Invoice through the website at https://portal.Tungsten-Network.com/Login.aspx. For questions regarding the submission of VA electronic invoices, Tungsten Network customer service may be contacted at 1-877-489-6135.

e. All invoices shall reference the vendor name and address, customer name, purchase order number, appropriate obligation/funding order number, description of services provided, quantity, unit price, and total invoice amount (any additional info). Invoices shall also include any payment discount terms.

4. GOVERNMENT INVOICE ADDRESS (See SF1449 Block 18):

a. All invoices from the contractor shall be submitted electronically in accordance with 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)

b. Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests.

c. VA’s Electronic Invoice Presentment and Payment System – The Veterans Affairs Financial Services Center (VAFSC) uses a third-party contractor, Tungsten Network e-Invoice, to transition vendors from paper to electronic invoice submission. Please go to this website: http://www.tungsten-network.com/customer-campaigns/veterans-affairs-us/ to begin submitting electronic invoices, free of charge.

d. As of July 1, 2020, the VA10091 form has been eliminated and the VAFSC is requiring our vendors to update and add their information in the Customer Engagement Portal (CEP) at https://www.cep.fsc.va.gov/. This is for new vendors being added to FMS only.

e. For assistance setting up e-Invoice, the below information is provided:

i. * Tungsten Network e-Invoice Setup Information: 1-877-489-6135

* Tungsten Network e-Invoice email: VA.Registration@Tungsten-Network.com

* FSC e-Invoice Contact Information: 1-877-353-9791

* FSC e-invoice email: vafsccshd@va.gov

5. ACQUISITION OF COMMERCIAL ITEMS:

This Request for Quote (RFQ) solicitation is issued under the authority of FAR Part 13.5 Simplified Procedures for Certain Commercial Items in which simplified acquisition procedures in FAR Part 13 will be used. FAR Part 14 and 15 will not be used. From this RFQ, the Government intends to award a firm fixed price purchase order where the contractor provides a price that is not subject to any adjustment on the basis of the contractor’s cost experience in performing the purchase order.

6. RFQ QUESTIONS:

In order to maintain integrity of this solicitation and subsequent award date, all offerors are advised that any question and answer requests must be submitted in a written form via e-mail to the Contract Specialist joni.dorr@va.gov no later than Tuesday, July 25, 2023 at 10:00 am Local Time (Central). Contracting will issue a consolidated response via solicitation amendment to https://beta.sam.gov Contract Opportunities within 2 business days to all parties.

7. CONTRACTING OFFICER AUTHORITY:

The Contracting Officer is the only person authorized to approve changes or modify any of the requirements under this purchase order. The Contractor shall communicate with the Contracting Officer on all matters pertaining to purchase order administration. Only the Contracting Officer is authorized to make commitment or issue changes that will affect price, quantity or quality of performance of this purchase order. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered to have been made without authority and no adjustment will be made in the purchase order price to cover any increase in cost incurred thereof.

8. IDENTIFICATION, PARKING, SMOKING AND VA REGULATIONS:

a. All VA property is considered Federal Property and all Federal laws are applicable.

b. It is the responsibility of the Contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police Section. The VA will not invalidate or make reimbursement for parking violations of the Contractor under any conditions.

c. All VA facilities are drug free. Possession of drugs, to include Marijuana and all Marijuana bi-products are prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.

d. All contractor personnel are required to adhere to all VA rules and regulations.

e. Smoking is prohibited on the entire campus, both inside and outside the VA Facility

f. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.

g. VHA DIRECTIVE 1192: This Veterans Health Administration (VHA) directive establishes policy and provides guidance for the prevention of seasonal influenza in VHA facilities through the vaccination or masking of health care personnel (HCP). AUTHORITY: Title 38 United States Code (U.S.C.) 7301(b), 7318(b). Contractor is responsible in ensuring that all aspects of this directive are implemented, including providing face masks and influenza vaccines for all employees working at a VA facility.

h. While on campus, all persons may be required to wear masks inside any VA Medical Center building, walking on the grounds, and while traveling in vehicles. Contractor shall confirm with COR before arrival of current mask mandate.

9. SECURITY & PRIVACY CONTROL:

All contractor employees are subject to the same level of investigation as VA employees who have access to VA Sensitive Information. The level of background investigation commensurate with the level of access needed to perform in accordance with the statement of work is: Special Agreement Check (SAC) & National Agency Check with Inquiries (NACI). This requirement is applicable to all subcontractor personnel requiring the same access.

The current FY23 fees associated with background investigations are as follows:

The SAC fingerprints charge is $20. This fee is the responsibility of the Contractor and will be billed accordingly.

10. BUSINESS ASSOCIATE AGREEMENT (BAA):

Contractor shall have a complete, approved Business Associate Agreement (BAA) with the VA prior to performing services.

11. VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE:

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.

Access To VA Information and VA Information Systems

a. A contractor/subcontrator 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.

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.

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 vulnerability 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 COTR 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 COTR. 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;

i. 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

ii. 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.

iii. 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.

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 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.

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:

i. date of occurrence;

ii. 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 $37.50 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

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.

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 COTR 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.

36C25223Q0580

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.2 STATEMENT OF WORK

Cardiac (Telemetry and Bedside Monitoring) Documentation and Reporting Digital Solution for VISN 12

1. Overview

1.1. Introduction

Veterans Integrated Service Network (VISN) 12, which consists of Edward Hines Jr. VA Hospital located in Hines, IL; Captain James A. Lovell Federal Health Care Center (FHCC) located in North Chicago, IL; VA Illiana Health Care System located in Danville, IL; Jesse Brown VA Medical Center located in Chicago, IL; Clement J Zablocki VA Medical Center located in Milwaukee, WI; William S. Middleton Memorial Veterans Hospital located in Madison, WI; Oscar G. Johnson VA Medical Center located in Iron Mountain, MI; Tomah VA Medical Center located in Tomah, WI; and VISN 12 associated Community Based Outpatient Clinic (CBOC) Milo C. Huempfner VA Outpatient Clinic located in Green Bay, WI have a requirement to procure a Contractor-agnostic comprehensive Cardiac (telemetry and bedside monitor) Patient Documentation and Reporting Digital Solution that integrates to patient monitoring networks and to the Department of Veterans Affairs (VA’s) Electronic Health Record (EHR). The main functionality of this solution shall allow for digital documentation of ECG waveform strips from patient telemetry and bedside monitoring system. The solution shall then provide the ability to send the documented ECG strips digitally into to the medical center's legacy EHR system and future EHR system.

1.2. Selection Criteria

VISN 12 intends to do a comparative analysis evaluation. Technical evaluation factors shall be included in accordance with FAR Clause 52.212-1.

1.3. Purchase Order Type

Base year plus four (4) one-year options

2. Project Scope/Objective

2.1. Project Management Services

Contractor shall provide management services to coordinate all aspects of this project. Contractor shall provide a schedule within 30 days of award that outlines a project completion in an agreed upon timeframe with the Contracting Officer Representative (COR).

2.2. Project Milestones

Contractor project schedule shall include the following milestones, for each VISN 12 facility.

i. Install Production and Test Server

ii. Integrate solution to Patient Monitoring network

iii. Complete all other integrations

iv. Develop and implement integration of solution to Legacy EHR (VA’s specific implementation of VistA (aka CPRS)

v. Develop and implement integration of solution to VA’s specific implementation of Cerner Millennium

vi. Complete needed configuration

vii. Implement solution

viii. Test solution

ix. Complete training

x. Go-Live

2.3. Project Dependencies

Authorization to operate on the VA Network through VA Directive 6550 and Enterprise Risk Assessment (ERA) process. Assume approval 60 days after award if ERA does not exist.

All Systems shall be tested in non-production environment before go-live date or go-live date will be delayed.

Contractor to provide all software, licensing, integration, development, and installation services required.

2.4. Document Deliverables

1. Project Schedule

2. The following documents will be required and shall be necessary for authorization on the VA network. Templates provided in Section D:

a. Network topology

b. Ports and protocols

c. Software Inventory

d. VA Directive 6550 Appendix A

e. Manufacturer Disclosure Statement for Security (MDS2)

3. Must provide VA Enterprise Risk Assessment (ERA), if a VA ERA exists.

a. If ERA does not exist, ERA approval must be obtained after complete package submission. This needs to be accounted for in the project schedule.

3. Standards/Requirements

3.1. Integration Requirements

· Patient Monitoring

· Integrate to all patient monitoring systems in VISN 12 to the patient monitoring vendors’ current software and current version

· GE Patient Monitoring for FHCC, Clement J. Zablocki VA Medical Center, Edward Hines Jr. VA Hospital, Jesse Brown VA Medical Center, Oscar G. Johnson VA Medical Center, and Milo C. Huempfner VA Outpatient Clinic

· Philips Patient Monitoring for William S. Middleton Memorial Veterans Hospital and Tomah VA Medical Center

· Spacelabs Patient Monitoring is currently installed at VA Illiana Health Care System, but currently under contract for migration to GE

· Vendor must specifically highlight if additional procurements shall be needed for their integration

· For example, what servers, software, and/or licensing shall be required to make the integration functional

· Integration must capture all patient data – waveforms, alarms, vital signs, etc.

Number of Monitored Beds by Location

Monitored Beds

Edward Hines Jr. VA Hospital (578)
326
Captain James A. Lovell Federal Health Care Center (FHCC) (556)
124
VA Illiana Health Care System (550)
34
Jesse Brown VA Medical Center (537)
198
Clement J. Zablocki VA Medical Center (695)
225
William S Middleton Memorial Veterans Hospital (607)
150
Oscar G. Johnson VA Medical Center (585)
35
Tomah VA Medical Center (676)
18
Milo C. Huempfner VA Outpatient Clinic (CBOC)
45

· Electronic Health Record (EHR)

· Integrate to both Legacy and new EHR to send Documented Cardiac Strips into patient’s electronic health record

· VA’s specific implementation of VistA (aka CPRS) - current Legacy EHR

· Integration must send a PDF of the cardiac strip report to VistA Imaging and generate a TIU note in VistA CPRS that references the VistA Imaging report

· Contractor must specifically highlight if additional procurements shall be needed for their integration to VistA

· Servers, software, and/or licenses shall be required to make integration functional. It shall be otherwise be assumed that this shall be provided by the Contractor

· VA’s specific implementation of Cerner Millennium – future EHR

· Integration to VA’s Cerner implementation must be approved by VA EHRM Office of Functional Champions (OfC) and prioritized by VA DCIO to integrate with Cerner

· Shall include all labor, time and materials, to develop, implement, and sustain integration for all VISN 12 locations (including any referenced CBOCs) throughout the purchase order period of performance

· Must have a production and a test server

· The solution must work for both inpatient AND outpatient areas that have the same cardiac strip reporting workflow as inpatient areas.

· Active Directory

· Integrate to Active Directory for single sign on in accordance with the Personal Identity Verification (PIV) Compliance Playbook – see attachment AD-IWA in Section D

· Solution must be Single Sign On

· Single Sign On must be achieved using Integrated Windows Authentication (IWA) - see attachment AD-IWA in Section D

· FHCC Department of Defense (DOD) employees have Common Access Card (CAC) cards rather than PIV cards

· Additional testing may be required to accommodate this distinction

3.2. Technical requirements

· The following documents shall be required and shall be necessary for authorization for the VA network. Templates provided in Section D:

· 1. Network topology

· 2. Ports and protocols

· 3. Software Inventory

· 4. VA Directive 6550 Appendix A

· 5. Manufacturer Disclosure Statement for Security (MDS2)

· Must provide VA Enterprise Risk Assessment (ERA), if a VA ERA exists.

· If ERA does not exist, ERA approval must be obtained after complete package submission. This needs to be accounted for in the project schedule.

· Servers must be able to be run as virtual machines (VMs) on a VA provided on-premises ESXi host

· Must have Technical Reference Manual (TRM) (http://trm.oit.va.gov/TRMHomePage.aspx) approval for client software and all components of client software. Manufacturer shall verify there shall be no prohibited components of their software in TRM.

· For any web browser functionality, it must be able to be run in Microsoft Edge

· Contractor must obtain credentials required for Remote Access or have an approved Site to Site Virtual Private Network (VPN) tunnel with VA to remotely support product. Software and support must function without any generic interactive domain service account.

· Must support regular Operating System (OS) patching

· Must be run on a supported OS

· Must support regular backups of data

· Ability to chain VISN 12 VA Medical Centers (VAMC) servers together (for certain facilities)

· End users must see beds from other facility(ies) directly in their Graphical User Interface (GUI). They shall not be required to switch to a separate GUI.

3.3. Clinical Functionality Requirements

· Display Electrocardiogram (ECG) waveforms to the end user in near real time (at most, a 1 second delay)

· View ECG data in Full Disclosure mode

· Need ability to go back at least 12 months

· Store waveforms, alarm data, and vitals sign data for all patients on bedside or telemetry monitoring in hospital for at least 12 months. Shall have ability to view this data in near real-time.

· Need quick, efficient way to grab current ECG waveform strip described in the following:

· Finding a Strip

· Search by patient Medical Record Number (MRN), patient name, and/or time

· Documentation of Strip

· Use digital calipers to measure cardiac waveforms in hundredths of a second increments

· Workflow of Strip from Generation, Documentation, to Including in Report

· Select the patient

· Select new strip for immediate documentation or to place in holding queue

· Document strip

· Measure waveforms with digital calipers

· Add interpretation (i.e. Normal Sinus Rhythm)

· Add comments if needed

· The solution shall automatically label what user originally saved the strip, and who documented the strip. The user's name will be pulled from the AD integration.

· Place documented strip in holding queue, or immediately send to EHR as urgent strip

· Strips shall be sent to medical record in one of two ways: a routine strip report or an urgent strip report

· A routine strip report shall include all documented strips since the last strip report was sent

· Urgent strips shall go immediately into the patient record for critical patient events

· Urgent Strips should be clearly identifiable and distinguishable from normal Strip Reports in the TeleDoc Solution

· Generate a report containing all document strips from holding queue, and send shift report into EHR

· Registered Nurses (RNs) shall have ability to add strips to their own holding queue for documentation later in shift

· Ability to view strips associated to patient alarms (i.e. tachycardia)

· Cross site Strip Documentation workflow

· Ability to chain servers together so that staff can remotely monitor beds from a smaller facility. (I.e Oscar G. Johnson VA Medical Center beds / ECG waveforms need to be displayed in both Clement J. Zablocki VA Medical Center and Oscar G. Johnson VA Medical Center GUI.)

· View other sites’ patient beds without logging into a different environment

· A Supporting facility use must see both facilities’ patients in GUI. Recipient facility does not see both.

· Documented strips go into EHR to where patient shall be physically located

· The Supporting Facility user shall not need access to Recipient Facility’s EHR for facilitation of this use-case

· Ability for tele-tech to get urgent strips right to RN and immediately into EHR

· Single sign on via active directory integration functional requirements:

· Roles and access shall be based on membership to active directory group

· i.e.) An Active Directory (AD) group in Milwaukee named VHAMIWTeleDocUsers, and a user must be part of that group to get User Level permissions in TeleDoc solution. Similar scenario for Admin Level role.

3.4. Tele-Tech Staff Specific Functional Requirements

· System must be searchable and filterable by patient name, patient ID, room/unit, timeframe, and alarm history. Must be able to search and filter by one or a combination of these parameters.

· For filtering, include room number and filter by unit as defined by patient monitoring system

· Send urgent strips immediately into EHR via a button click – have a Comments area where staff can write free text who they notified of the alarm/tele concern

· Capture waveforms that go into a queue for nursing staff to interpret

· Ability to review retroactive/historic ECG strips, waveforms, alarms, and vital signs

· Retroactive/historic ECG strips, waveforms need to display as a full disclosure view to see waveforms across user-definable timeframes, in a single view. From this view, they shall be able to drill in and select a waveform strip for potential addition to the shift report.

· Shall have ability to preview strip report prior to sending to EHR. Shall have option to save report to computer as well as print report, from the preview view.

· Ability to view previously sent reports from GUI

· Ability to edit the report (I.e. save a strip to a previously saved report).

3.5. Nursing staff specific Functional Requirements

· System must be searchable and filterable by patient name, patient ID, room/unit, timeframe, and/or alarm history. Must be able to search and filter by one or a combination of these parameters.

· For filtering, include room number and filter by unit as defined by patient monitoring system

· Send urgent strips immediately into EHR via a button click - have a Comments area where staff can write free text who they notified of the alarm/tele concern

· Capture waveforms that go into a queue

· Review & document ECG waveforms in their queue from tele-tech and strips they had added to their own queue

· Document ECG waveform segment measurements with digital calipers.

This is the start of the file's text. The full file is on GovTribe.

File details come from the government source that posted it. Updated .