36C10B21R0030 (CIS-ARK) FINAL 6August2021.docx

36C10B21R0030

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.

DUNS:

DUNS+4:

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. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C10B21R0030 08-06-2021 James Cummiskey – Contract Specialist 848-377-5117 08-11-2021

1:00 PM

EDT

36C10B Department of Veterans Affairs Technology Acquisition Center

23 Christopher Way Eatontown NJ 07724

X

541519 $30 Million

N/A

36C10B Department of Veterans Affairs Technology Acquisition Center

23 Christopher Way Eatontown NJ 07724

36C10A Department of Veterans Affairs Technology Acquisition Center Financial Services Center PO Box 149971 Austin TX 78714-8971

See CONTINUATION Page Clinical Information System/Anesthesia Record Keeping (CIS/ARK) Analytics/Decision Support Solution

See Price Schedule and Performance Work Statement

This Request for Proposal (RFP) will result in a Firm-Fixed Price (FFP) Contract.

Period of Performance is 6 months from date of award, with one 6-month Option Period.

See CONTINUATION Page

Heather Utt

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 GOVERNING LAW

Federal law and regulations, including the Federal Acquisition Regulations (FAR), shall govern this Contract/Order. Commercial license agreements may be made a part of this Contract/Order but only if both parties expressly make them an addendum hereto, as permitted by FAR 12.212. If the commercial license agreement is not made an addendum, it shall not apply, govern, be a part of or have any effect whatsoever on the Contract/Order; this includes, but is not limited to, any agreement embedded in the computer software (clickwrap), any agreement that is otherwise delivered with or provided to the Government with the commercial computer software or documentation (shrinkwrap), or any other license agreement otherwise referred to in any document. If a commercial license agreement is made an addendum, only those provisions addressing data rights regarding the Government’s use, duplication and disclosure of data (e.g., restricted computer software) are included and made a part of this Contract/Order, and only to the extent that those provisions are not duplicative or inconsistent with Federal law, Federal regulation, the incorporated FAR clauses and the provisions of this Contract/Order; those provisions in the commercial license agreement that do not address data rights regarding the Government’s use, duplication and disclosure of data shall not be included or made a part of the Contract/Order. Federal law and regulation including, without limitation, the Contract Disputes Act (41 U.S.C. § 7101 et seq.), the Anti-Deficiency Act (31 U.S.C. § 1341 et seq.), the Competition in Contracting Act (41 U.S.C. § 3301 et seq.), the Prompt Payment Act (31 U.S.C. § 3901 et seq.), Contracts for Data Processing or Maintenance (38 USC § 5725), and FAR clauses 52.212-4, 52.227-14, 52.227-19 shall supersede, control, and render ineffective any inconsistent, conflicting, or duplicative provision in any commercial license agreement. In the event of conflict between this clause and any provision in the Contract/Order or the commercial license agreement or elsewhere, the terms of this clause shall prevail. The Contractor shall deliver to the Government all data first produced under this Contract/Order with unlimited rights as defined by FAR 52.227-14. Claims of patent or copyright infringement brought against the Government as a party shall be defended by the U.S. Department of Justice (DOJ) in accordance with 28 U.S.C. § 516; at the discretion of DOJ, the Contractor may be allowed reasonable participation in the defense of the litigation. Any additional changes to the Contract/Order must be made by modification (Standard Form 30) and shall only be made by a warranted Contracting Officer. Nothing in this Contract/Order or any commercial license agreement shall be construed as a waiver of sovereign immunity.

B.2 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

b. GOVERNMENT: Heather Utt, Contracting Officer 36C10B Department of Veterans Affairs Technology Acquisition Center 23 Christopher Way Eatontown NJ 07724

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

3. INVOICES: Invoices shall be submitted 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.

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

B.3 PRICE SCHEDULE

Base Period

Period of Performance (PoP): Six (6) Months This CLIN includes all tasks, labor and travel required for the successful completion of the services detailed in PWS section 5.1 and all subparagraphs.

Due NLT 30 days after contract award, update upon staffing change.

Electronic submission to: VA PM, COR, CO.

Inspection: destination Acceptance: destination

Due thirty (30) days after contract award and update monthly thereafter.

Electronic submission to: VA PM, COR, CO.

Inspection: destination Acceptance: destination

PoP: Six (6) Months This CLIN includes all tasks, labor and travel required for the successful completion of the services detailed in PWS section 5.2.

3 Days after Contract Award.

Electronic submission to: VA PM, COR, CO.

Inspection: destination Acceptance: destination

This CLIN includes all tasks, labor and travel required for the successful completion of the services detailed in PWS section 5.3 and all subparagraphs.

Performance to commence upon approval/acceptance of the CIS/ARK Analytic/Decision Support Solution.

Inspection: destination Acceptance: destination

Due NLT 60 days after contract award.

Electronic submission to: VA PM, COR, CO.

Inspection: destination Acceptance: destination

Due within 30 days prior to end of PoP.

Electronic submission to: VA PM, COR, CO.

Inspection: destination Acceptance: destination

This CLIN includes all tasks, labor and travel required for the successful completion of the services detailed in PWS section 5.4.

Performance to commence upon approval/acceptance of the CIS/ARK Analytic/Decision Support Solution.

Inspection: destination Acceptance: destination

Draft Due within the first 30 days after contract award, with final after Govt. approval.

Electronic submission to: VA PM, COR, CO.

Inspection: destination Acceptance: destination

Due before 1st class and updated as required.

Electronic submission to: VA PM, COR, CO.

Inspection: destination Acceptance: destination

Due before 1st class and updated as required.

Electronic submission to: VA PM, COR, CO.

Inspection: destination Acceptance: destination

Due before 1st Class and updated as required.

Electronic submission to: VA PM, COR, CO.

Inspection: destination Acceptance: destination

Due before 1st Class and updated as required.

Electronic submission to: VA PM, COR, CO.

Inspection: destination Acceptance: destination

This CLIN includes all tasks, labor and travel required for the successful completion of the services detailed in PWS section 5.5.

Performance to commence upon approval/acceptance of the CIS/ARK Analytic/Decision Support Solution.

Inspection: destination Acceptance: destination

Due 3rd business day of each month, throughout the POP.

Electronic submission to: VA PM, COR, CO.

Inspection: destination Acceptance: destination

Due 5 days after testing is completed.

Electronic submission to: VA PM, COR, CO.

Inspection: destination Acceptance: destination

Option Period 1 (Unexercised) This Option Period may be exercised In Accordance With (IAW) FAR 52.217-9 “Option to Extend the Term of the Contract” (MAR 2000)

Period of Performance (PoP): Six (6) Months This CLIN includes all tasks, labor and travel required for the successful completion of the services detailed in PWS section 5.1.

Inspection: destination Acceptance: destination

Due NLT 30 days after contract award, update upon staffing change.

Electronic submission to: VA PM, COR, CO.

Inspection: destination Acceptance: destination

PoP: Six (6) Months This CLIN includes all tasks, labor and travel required for the successful completion of the services detailed in PWS section 5.2.

Electronic submission to: VA PM, COR, CO.

Inspection: destination Acceptance: destination

This CLIN includes all tasks, labor and travel required for the successful completion of the services detailed in PWS section 5.3 and all subparagraphs.

Performance to commence upon approval/acceptance of the CIS/ARK Analytic/Decision Support Solution Inspection: destination Acceptance: destination

Due five (5) days after Government request.

Electronic submission to: VA PM, COR, CO.

Inspection: destination Acceptance: destination

Due within 30 days prior to end of PoP.

Electronic submission to: VA PM, COR, CO.

Inspection: destination Acceptance: destination

This CLIN includes all tasks, labor and travel required for the successful completion of the services detailed in PWS section 5.4.

Performance to commence upon approval/acceptance of the CIS/ARK Analytic/Decision Support Solution.

Inspection: destination Acceptance: destination

Draft Due within the first 30 days after contract award, with final after Govt. approval.

Electronic submission to: VA PM, COR, CO.

Inspection: destination Acceptance: destination

Due before 1st Class and update as required.

Electronic submission to: VA PM, COR, CO.

Inspection: destination Acceptance: destination

Due before 1st Class and update as required.

Electronic submission to: VA PM, COR, CO.

Inspection: destination Acceptance: destination

Due before 1st Class and update as required.

Electronic submission to: VA PM, COR, CO.

Inspection: destination Acceptance: destination

Due before 1st Class and update as required.

Electronic submission to: VA PM, COR, CO.

Inspection: destination Acceptance: destination

This CLIN includes all tasks, labor and travel required for the successful completion of the services detailed in PWS section 5.5.

Performance to commence upon approval/acceptance of the CIS/ARK Analytic/Decision Support Solution.

Inspection: destination Acceptance: destination

Due 3rd business day of each month, throughout the POP.

Electronic submission to: VA PM, COR, CO.

Inspection: destination Acceptance: destination

OPTIONAL TASK 1 – Refresher Training This optional task and can be exercised at any point during the Base Period and/or Option Period 1, IAW FAR 52.217-7, Option for Increased Quantity – Separately Priced Line Item.

Work shall not commence until, and unless, a formal modification is issued by the Contracting Officer.

If Optional Task 1 is exercised by VA, the Contractor shall perform the tasks identified in Section 5.6 of the PWS.

Not-To-Exceed 40 Hours Inspection: destination Acceptance: destination

B.4 PERFORMANCE WORK STATEMENT

1.0 BACKGROUND

The mission of the Department of Veterans Affairs (VA), Veterans Health Administration (VHA) is to provide health care benefits and services to Veterans of the United States. In meeting this goal, VHA strives to provide high quality, effective, and efficient Medical Informatics systems to those responsible for providing care to Veterans in an effective, timely and compassionate manner. VHA depends on these systems to meet mission goals.

In Veterans Integrated Service Network (VISN) 21, Acute and Critical Care data of Intensive Care Unit (ICU), Intermediate Intensive Care Unit (IICU), Operating Room (OR), and Post Anesthesia Care Unit (PACU) data sets is stored in VISN 21 Picis Clinical Information System/Anesthesia Record Keeping System (CIS/ARK) database. The CIS/ARK system itself is maintained by a combination of Original Equipment Manufacturer (OEM) vendor staff under a software/support maintenance contract and VISN 21 staff. Picis is a vendor that provides the perioperative and critical care software and performs routine maintenance support for VISN 21.

The VISN 21 facilities covered by the Picis CIS/ARK Systems are as follows:

· San Francisco VA Medical Center, 4150 Clement Street, San Francisco, CA

· VA Central California Health Care System, 2615 E. Clinton Avenue, Fresno, CA

· VA Northern California Health Care System (including Sacramento and Martinez), 10535 Hospital Way, Sacramento, CA

· VA Palo Alto Health Care System, 3801 Miranda Avenue, Palo Alto, CA

· VA Sierra Nevada Health Care System, 1000 Locust Street, Reno, NV

· VA Southern Nevada Healthcare System, 6900 North Pecos Road, North Las Vegas, NV An overview of current CIS/ARK data sources are provided at Attachment 1 (Picis 8.2 Hardware Diagram – see page 48) and Attachment 2 (Picis 8.6 Hardware Diagram – see page 49).

The CIS/ARK system promotes facility level care and population level surveillance and research within VA. The overarching goal is the ongoing quality improvement of processes, care, and outcomes (both morbidity and mortality) for the surgical and critically ill patients; and the optimization of efficiency within care sites including but not exclusive of the OR, PACU, and ICU. The utilization of standardized, objective data from the CIS/ARK databases and electronic medical records i.e. Veterans Health Information Systems and Technology Architecture (VistA) electronic health record (EHR) have long been a goal of the VHA in establishing itself as a leader in the field of perioperative and critical care.

2.0 APPLICABLE DOCUMENTS

In the performance of the tasks associated with this Performance Work Statement, the Contractor shall comply with the following:

1. 44 U.S.C. § 3541, “Federal Information Security Management Act (FISMA) of 2002”

2. Federal Information Processing Standards (FIPS) Publication 140-2, “Security Requirements For Cryptographic Modules”

3. FIPS Pub 201-2, “Personal Identity Verification of Federal Employees and Contractors,” August 2013

4. 10 U.S.C. § 2224, "Defense Information Assurance Program"

5. Carnegie Mellon Software Engineering Institute, Capability Maturity Model® Integration for Development (CMMI-DEV), Version 1.3 November 2010; and Carnegie Mellon Software Engineering Institute, Capability Maturity Model® Integration for Acquisition (CMMI-ACQ), Version 1.3 November 2010

6. 5 U.S.C. § 552a, as amended, “The Privacy Act of 1974”

7. 42 U.S.C. § 2000d “Title VI of the Civil Rights Act of 1964”

8. VA Directive 0710, “Personnel Suitability and Security Program,” June 4, 2010, http://www.va.gov/vapubs/

9. VA Handbook 0710, Personnel Suitability and Security Program, September 10, 2004, http://www.va.gov/vapubs

10. VA Directive and Handbook 6102, “Internet/Intranet Services,” July 15, 2008

11. 36 C.F.R. Part 1194 “Electronic and Information Technology Accessibility Standards,” July 1, 2003

12. Office of Management and Budget (OMB) Circular A-130, “Management of Federal Information Resources,” November 28, 2000

13. 32 C.F.R. Part 199, “Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)”

14. An Introductory Resource Guide for Implementing the Health Insurance Portability and Accountability Act (HIPAA) Security Rule, October 2008

15. Sections 504 and 508 of the Rehabilitation Act (29 U.S.C. § 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998

16. Homeland Security Presidential Directive (12) (HSPD-12), August 27, 2004

17. VA Directive 6500, “Managing Information Security Risk: VA Information Security Program,” September 20, 2012

18. VA Handbook 6500, “Risk Management Framework for VA Information Systems – Tier 3: VA Information Security Program,” March 10, 2015

19. VA Handbook 6500.1, “Electronic Media Sanitization,” November 03, 2008

20. VA Handbook 6500.2, “Management of Data Breaches Involving Sensitive Personal Information (SPI)”, January 6, 2012

21. VA Handbook 6500.3, “Assessment, Authorization, And Continuous Monitoring Of VA Information Systems,” February 3, 2014

22. VA Handbook 6500.5, “Incorporating Security and Privacy in System Development Lifecycle” March 22, 2010

23. VA Handbook 6500.6, “Contract Security,” March 12, 2010

24. VA Handbook 6500.8, “Information System Contingency Planning”, April 6, 2011

25. Project Management Accountability System (PMAS) portal (reference https://www.voa.va.gov/pmas/)

26. OI&T ProPath Process Methodology (reference process maps at http://www.va.gov/PROPATH/Maps.asp and templates at http://www.va.gov/PROPATH/Templates.asp

27. One-VA Technical Reference Model (TRM) (reference at http://www.va.gov/trm/TRMHomePage.asp)

28. National Institute Standards and Technology (NIST) Special Publications (SP)

29. VA Directive 6508, VA Privacy Impact Assessment, October 3, 2008

30. VA Directive 6300, Records and Information Management, February 26, 2009

31. VA Handbook, 6300.1, Records Management Procedures, March 24, 2010

32. OMB Memorandum, “Transition to IPv6”, September 28, 2010

33. VA Directive 0735, Homeland Security Presidential Directive 12 (HSPD-12) Program, February 17, 2011

34. VA Handbook 0735, Homeland Security Presidential Directive 12 (HSPD-12) Program, March 20, 2014

35. OMB Memorandum M-06-18, Acquisition of Products and Services for Implementation of HSPD-12, June 30, 2006

36. OMB Memorandum 05-24, Implementation of Homeland Security Presidential Directive (HSPD) 12 – Policy for a Common Identification Standard for Federal Employees and Contractors, August 5, 2005

37. OMB memorandum M-11-11, “Continued Implementation of Homeland Security Presidential Directive (HSPD) 12 – Policy for a Common Identification Standard for Federal Employees and Contractors, February 3, 2011

38. OMB Memorandum, Guidance for Homeland Security Presidential Directive (HSPD) 12 Implementation, May 23, 2008

39. Federal Identity, Credential, and Access Management (FICAM) Roadmap and Implementation Guidance, December 2, 2011

40. NIST SP 800-116, A Recommendation for the Use of Personal Identity Verification (PIV) Credentials in Physical Access Control Systems, November 20, 2008

41. OMB Memorandum M-07-16, Safeguarding Against and Responding to the Breach of Personally Identifiable Information, May 22, 2007

42. NIST SP 800-63-2, Electronic Authentication Guideline, August 2013

43. Draft NIST Special Publication 800-157, Guidelines for Derived PIV Credentials, March 2014

44. NIST Special Publication 800-164, Guidelines on Hardware-Rooted Security in Mobile Devices (Draft), October 2012

45. Draft National Institute of Standards and Technology Interagency Report (NISTIR) 7981 Mobile, PIV, and Authentication, March 2014

46. VA Memorandum, VAIQ #7100147, Continued Implementation of Homeland Security Presidential Directive 12 (HSPD-12), April 29, 2011 (reference https://www.voa.va.gov/documentlistpublic.aspx?NodeID=514)

47. VA Memorandum, VAIQ # 7011145, VA Identity Management Policy, June 28, 2010 (reference Enterprise Architecture Section, PIV/IAM (reference https://www.voa.va.gov/documentlistpublic.aspx?NodeID=514)

48. IAM Identity Management Business Requirements Guidance document, May 2013, (reference Enterprise Architecture Section, PIV/IAM (reference https://www.voa.va.gov/documentlistpublic.aspx?NodeID=514)

49. Trusted Internet Connections (TIC) Reference Architecture Document, Version 2.0, Federal Interagency Technical Reference Architectures, Department of Homeland Security, October 1, 2013, https://www.fedramp.gov/files/2015/04/TIC_Ref_Arch_v2-0_2013.pdf

50. OMB Memorandum M-08-05, “Implementation of Trusted Internet Connections (TIC), November 20, 2007

51. OMB Memorandum M-08-23, Securing the Federal Government’s Domain Name System Infrastructure, August 22, 2008

52. VA Memorandum, VAIQ #7497987, Compliance – Electronic Product Environmental Assessment Tool (EPEAT) – IT Electronic Equipment, August 11, 2014 (reference Document Libraries, EPEAT/Green Purchasing Section, https://www.voa.va.gov/documentlistpublic.aspx?NodeID=552)

53. Sections 524 and 525 of the Energy Independence and Security Act of 2007, (Public Law 110–140), December 19, 2007

54. Section 104 of the Energy Policy Act of 2005, (Public Law 109–58), August 8, 2005

55. Executive Order 13514, “Federal Leadership in Environmental, Energy, and Economic Performance,” October 5, 2009

56. Executive Order 13423, “Strengthening Federal Environmental, Energy, and Transportation Management,” January 24, 2007

57. Executive Order 13221, “Energy-Efficient Standby Power Devices,” August 2, 2001

58. VA Directive 0058, “VA Green Purchasing Program”, July 19, 2013

59. VA Handbook 0058, “VA Green Purchasing Program”, July 19, 2013

60. Office of Information Security (OIS) VAIQ #7424808 Memorandum, “Remote Access”, January 15, 2014, https://www.voa.va.gov/DocumentListPublic.aspx?NodeId=28

61. Clinger-Cohen Act of 1996, 40 U.S.C. §11101 and §11103

62. VA Directive 6071, Project Management Accountability System (PMAS), February 20, 2013

63. VA Memorandum, “Implementation of Federal Personal Identity Verification (PIV) Credentials for Federal and Contractor Access to VA IT Systems”, (VAIQ# 7614373) July 9, 2015, https://www.voa.va.gov/DocumentListPublic.aspx?NodeId=28

64. VA Memorandum “Mandatory Use of PIV Multifactor Authentication to VA Information System” (VAIQ# 7613595), June 30, 2015, https://www.voa.va.gov/DocumentListPublic.aspx?NodeId=28

65. VA Memorandum “Mandatory Use of PIV Multifactor Authentication for Users with Elevated Privileges” (VAIQ# 7613597), June 30, 2015; https://www.voa.va.gov/DocumentListPublic.aspx?NodeId=28

66. VA Memorandum; VA Maintenance/Installation (Warranty) Contracts (VAIQ 7058822); March 24, 2011

67. VHA Directive 0004; Education and Learning Delivery Systems; April 2012

68. VHA Directive 6550; Pre-Procurement Assessment for Medical Devices; Current version

69. Health Technology Management (HTM) Service Bulletin SB2012-004; Removable Media Scanning; November 2012

70. Attachment A, CIS Specifications

71. Interconnection Security Agreement and Memorandum of Understanding between Department of Veterans Affairs and Picis ; May 18. 2018

72. Business Associate Agreements (BAA) Picis Clinical Solutions, Inc.

3.0 SCOPE OF WORK

The Contractor is required to provide a CIS/ARK Analytics/Decision Support Solution that is capable of performing extracts, report customization, and analytics services to aid in the improvement of quality of care for surgical and critically ill patients.

The Contractor shall provide a solution that will use multiple VA data sources including Picis, VistA, and Corporate Data Warehouse (CDW). This support solution shall allow multiple user groups including clinicians and clinical and business analysts the ability to create reports, analyze data, and facilitate ongoing quality improvement efforts in addressing:

The Contractor shall also provide analytics/reporting support services to the VISN 21 team and provide training and help desk support services.

4.0 PERFORMANCE DETAILS

4.1 PERFORMANCE PERIOD

The period of performance (PoP) shall be a base period of 6 months from the time of award of the contract, with one 6-month option period. The option period will be exercised at the discretion of the Government in accordance with PWS Paragraph 5.7

All support services shall be provided to the VISN 21 facilities during normal business hours. This entails 7:30 am- 5:00 pm Pacific Standard Time (PST) Monday – Friday, excluding Federal Holidays.

Any work at the Government site shall not take place on Federal holidays or weekends unless directed by the Contracting Officer (CO).

There are eleven (11) Federal holidays set by law (USC Title 5 Section 6103) that VA follows:

Under current definitions, five are set by date:

If any of the above falls on a Saturday, then Friday shall be observed as a holiday. Similarly, if one falls on a Sunday, then Monday shall be observed as a holiday.

The other six are set by a day of the week and month:

4.2 PLACE OF PERFORMANCE

Efforts under this contract shall be performed at the Contractor facility. Work may be performed at remote locations with prior approval of the Contracting Officer’s Representative (COR).

4.3 TRAVEL

VA is looking to reduce the cost of attending meeting related trips, therefore, online meetings are highly encouraged. Visits to medical centers may be required to perform software installation, on-site training and on-site technical support. The number of visits shall be based on the Contractor’s estimates needed to satisfy the tasks in Section 5.2 and 5.3.

5.0 SPECIFIC TASKS AND DELIVERABLES

The Contractor shall perform the following:

5.1 PROJECT MANAGEMENT

The Contractor shall provide a Project Manager (PM) who shall function as the point of contact between the Medical Director for VISN 21 Clinical Informatics Systems and Perioperative Analytics, COR and Contractor organization.

The Contractor PM shall:

a. Serve as liaison between Contractor team and VA staff in order to provide and/or obtain needed information as required for day-to-day operations.

b. Manage all Contractor staff associated with work to be performed under this PWS.

c. Be accountable for all contractual deliverables and ensure they are delivered on schedule.

d. Work closely on a daily basis with the CIS/ARK Project Manager coordinating schedules, risks, and dependencies.

e. Use Agile software development methodology (e.g. SCRUM) through implementing strategies and tools to improve manageability, reduce overall risk, and support rapid delivery of workable solutions.

f. Report all changes, identified risks, and dependencies to other CIS/ARK projects to the CIS/ARK Project Manager for review and approval.

g. Participate in weekly PM calls (along with other Contractor team members as needed)

h. Ensure that all work complies with VA-established policies, standards, and guidelines.

i. Provide Staffing Plan with a list of key personnel and their roles under this PWS. Notify the COR in writing of any staff changes on work associated with this PWS. The COR should be notified 10 business days in advance of any staff change. The written notification shall outline the reason for the change, the impact expected by the change, mitigation strategy to reduce the impact, and any schedule slip anticipated by the staff change. Any replacement staff shall have at minimum equivalent skills sets as need for work performed under this PWS.

Deliverable:

A. Staffing Plan

5.1.1 CONTRACTOR PROJECT MANAGEMENT PLAN

The Contractor shall update the existing Contractor Project Management Plan (CPMP) that lays out the Contractor’s approach, timeline and tools to be used in execution of the contract and deliver to the VA for concurrence. The CPMP should take the form of both a narrative and graphic format that displays the schedule, milestones, risks and resource support. The CPMP shall also include how the Contractor shall coordinate and execute planned, routine, and ad hoc data collection reporting requests as identified within the PWS.

Deliverable:

A. Contractor Project Management Plan

5.1.2 TECHNICAL KICKOFF MEETING

The Contractor shall hold a technical kickoff meeting within 10 days after contract award. The Contractor shall present, for review and approval by the Government, the details of the intended approach, work plan, and project schedule for each effort. The Contractor shall specify dates, locations (can be virtual), agenda (shall be provided to all attendees at least five calendar days prior to the meeting), and meeting minutes (shall be provided to all attendees within three calendar days after the meeting). The Contractor shall invite the Contracting Officer (CO), Contract Specialist (CS), COR, and the VA PM.

5.2 CIS/ARK ANALYTICS/DECISION SUPPORT SOLUTION

The Contractor shall provide a CIS/ARK Analytics/Decision Support Solution that is capable of performing extracts, report customization, and analytics services to aid in the improvement of quality of care for surgical and critically ill patients.

In providing an effective CIS/ARK Analytics/Decision Support Solution, the Contractor shall have knowledge of and be capable of:

· Creating Picis CIS/ARK data tables / structures in order to Extract, Transform and Load (ETL) Picis data from Oracle and SQL databases;

· Creating a stable ETL process to other hardware platforms;

· Providing data mapping documents;

· Extracting VistA data;

· Utilizing clinical database tables / structures;

· Constructing and creating a stable ETL process onto other hardware platforms.

The Contractor solution shall perform all stages of its ETL processes to monitor, cleanse, parse and validate for data quality. The Contractor shall possess in depth knowledge of VistA’s file structure and system which is essential to perform this task.

The Contractor solution shall apply commercially accepted clinical analytics business rule sets for Picis and VistA data element, normalize and load data for usage and display that data through a Graphical User interface (GUI) and reports.

The Contractor solution shall continue to provide reliable access to the Analytics Tool & Tool Sets including Surgical/Critical Care and Management Reports and Custom Reports through the GUI.

The Contractor solution shall continue to provide reliable access to a GUI for the necessary VISN data to be used for reports; point and click queries; research and ability to extract data for additional analyses and ability to produce ad-hoc analytics offline for experimentation and data science.

The Contractor may utilize VA owned virtual server(s) or use their own server solution to accomplish the ETL operation. The Contractor shall have an existing interface agreement or read-only interface with Picis or the cost to establish such access shall be included in the proposal. The Contractor solution shall be capable of supporting single sign-on (SSO) with VA-issued PIV cards and meet applicable VA Enterprise Risk Analysis requirements. If a cloud-based solution is proposed, the Contractor must have Federal Risk and Authorization Management Program (FedRAMP). The Contractor shall either have an existing Memorandum of Understanding/Interconnection Security Agreement (MOU/ISA) with the VA for remote access and active employee security credentials or shall pursue such access expeditiously.

The Contractor solution shall:

A. Be capable of developing customizable reports;

B. Be capable of developing data mapping document(s);

C. Provide VISN 21 users the ability to access original Picis datasets (i.e. normalized data stores);

D. Be capable of evaluating the data quality of the original Picis data and ensure the validity and verification of data elements;

E. Be capable of developing functional capabilities for VISN 21 users to conduct research. Functional capabilities consist of the CIS/ARK Analytics Support Solution that enables VISN 21 users to access the original Picis datasets with a series of analytic tools such that clinical research can be performed as needed. These analytic tools shall address the need of the VISN for:

1) Availability of data dictionaries within the application;

2) Staging time series data (i.e. physiology variables like heart rate or blood pressure) with rapid queries across different time scales;

3) Trend analysis tools;

4) Data visualization tools;

5) Incorporation of statistical packages (i.e. R) to conduct statistical analysis within application; and

6) Exporting to a variety of data formats (i.e., csv, sas, or .dta, etc).

The Contractor shall provide software licenses for use of their solution for all VISN 21 users at each VAMC identified in Section 1.0.

Deliverable:

A. CIS/ARK Analytics Solution Software licenses

5.3 ANALYTIC/REPORTING SERVICES

The Contractor shall provide analytics/reporting services. These services require skilled experienced analytics professionals and IT personnel i.e. programmers, database administrators are essential for successful contractor accomplishment of the work to be performed under this contract. This task involves the ability to use sophisticated statistical techniques such as time series analyses, sophisticated database manipulation i.e. table joins, ad hoc querying and a detailed familiarity with medical practices in critical care areas in a medical center. Also, skills, knowledge and experience with Picis databases and the VA’s VistA systems to create analytical reports from these data sources. The Contractor shall provide clinical / technical support for database report creation and analysis and customization of the user interface. It should be noted that all data generated under this contract shall remain the properties of the Government.

After successful implementation of the CIS/ARK Analytics/Decision Support Solution, the Contractor shall provide the following analytic/reporting services:

5.3.1 DEVELOPMENT OF CUSTOMIZABLE REPORTS

The Contractor shall:

1) Provide reliable access to a basic set of critical and surgical care clinical data reports that the VISN designated personnel (to include VISN Executive Management, Medical Center Clinical Leadership, Chief of Anesthesia, and ICU management) needs on a monthly basis. Based on the VISN’s needs, additional customizable reports may be needed, with data elements, these additions will be determined by the VISN.

2) VA is mandated by national programs (such as In-Patient Evaluation Center (IPEC)) to measure compliance on certain data elements entered in the patient record and into the electronic record (CIS/ARK Picis). VA needs reliable self-service access to the software platform to generate the necessary reports to meet reporting requirements and to support patient care and research objectives.

5.3.2 DATA MAPPING DOCUMENT(S)

The Contractor shall create data mapping documents to show data relationships to include the relationship between source and target data, primary keys, table staging, and data/value. The intent of these documents is to validate the extracted data sources. Data mapping document is needed after a significant change between source and target data. The provided data mapping documents shall encompass the full data set as well as when needed to document data mapping for new custom reports.

Deliverable:

A. Data Mapping Documents

5.3.3 ACCESS NORMALIZED DATA

The Contractor shall provide VISN 21 users the ability to access original datasets incorporated into the analytics system (i.e. normalized data stores). The Contractor shall provide a mechanism for the VISN CIS/ARK team to access normalized data stores of Picis datasets for each of the facilities. The Contractor shall customize a dashboard/interface that will be a Staging and Analytical platform for VISN 21 analytics.

Prior to the conclusion of the contract (within 45 to 60 days), the Contractor shall ensure VISN 21 users have the capability to access and query their original data, and that the source data shall either remain accessible in generic database tables (Structured Query Language (SQL)) or made available for export to an existing VA database/source dataset. Documentation regarding query and extract logic shall also be made available to the Government. The Contractor shall create a mirrored VISN 21 Analytics dataset (consisting of datasets past and present) to be set up on a pre-determined server for use by the CIS/ARK Analytics Team; read-only access is acceptable.

Deliverable:

A. Mirrored VISN 21 Analytics Dataset Stored onto pre-determined VA Server(s) and documentations

5.3.4 EVALUTION OF DATA QUALITY

The Contractor shall evaluate the data quality of the original Picis data and ensure the validity and verification of data elements. The Contractor shall evaluate data quality rules to include but not exclusive of attribute domain, relational integrity, historical validity, and state-dependency. The Contractor shall consult with the VISN CIS/ARK team to ensure these evaluations performed meets the team’s expected data outcomes.

5.3.5 FUNCTIONAL CAPABILITIES TO CONDUCT RESEARCH

The Contractor shall provide support services and functional capabilities to VISN 21 users with the ability to conduct research. These functionalities shall enable users to have the ability to access original Picis datasets (i.e. normalized data stores). The Contractor shall provide support services to VISN 21 users in performing queries and validation of data when necessary. The Contractor shall provide functional capabilities to conduct research. Functional capabilities consist of the CIS/ARK Analytics Support Solution that enables VISN 21 users to access the original PICIS datasets with a series of analytic tools (refer to Section 5.2.E).

5.4 TRAINING REQUIREMENTS

The Contractor shall provide virtual training to VISN 21 users/students. It is estimated that the Contractor will provide a total of three (3) training sessions for each 6 month period of performance. Each training session will consist of approximately 20 users.

The Contractor shall provide a Training Plan to the PM and COR for review. Upon approval of the Training Plan, the Contractor shall deliver the final training materials for use in the training sessions. The Contractor shall consult and work closely with the VISN 21 team to develop and deploy the training materials. The purpose of training manuals, classroom sessions, web sessions, etc. would include at a minimum to cover the following:

1) Accessing application based on level of authorization (basic; advanced; administrative users)

2) Users are able to use the Contractor’s solution in the analytic environment to create and maintain:

i. Quality improvement/resource utilization reports

ii. Custom provider reports

3) Navigating application

4) Designing queries

5) Executing standard reports

6) Designing and executing custom reports

7) Exporting data from the application

8) Gauge end user performance on training sessions

If virtual training is conducted, the Contractor shall present similar on-site training contents to students via online sessions. The Contractor shall present virtual training with online tutorial presentations. Students shall be provided all necessary training materials electronically prior to the start of the training.

Deliverables:

A. Training Plan B. Online Tutorial presentations C. Manuals D. Training Guides E. Training Classroom Materials

5.5 HELP DESK SUPPORT

The Contractor shall provide help desk support for VISN 21 users from Monday through Friday between the hours of 8:00AM and 5:00PM Pacific Standard Time except for federal holidays. Help desk support shall be available to support VISN 21 users after the CIS/ARK Analytics/Decision Support Solution is operational. The Contractor shall provide a designated point of contact(s) for direct communications from VA to the Contractor’s help desk support via phone, email and/or chat accessible. The Contractor shall provide help desk support to respond to the VISN’s end users’ needs. The Contractor shall work closely with the VISN CIS/ARK team and VISN designated personnel to meet regularly (can be telephonic) with sets of end users, identify their needs, and work with the CIS/ARK team to respond appropriately.

The Contractor shall be responsible for triaging inbound requests for support with the goal of achieving first call (tier 1) resolution of training issues and work arounds. Any issues that cannot be resolved by tier 1 will be escalated to tier 2 help desk support provided by the Contractor. The Contractor shall provide defect tracking. If there are any issues identified by VA and communicated to the Contractor, the Contractor shall track each issue and its resolution. The Contractor shall provide a monthly Help Desk Executive Summary Report identifying the number of help desk tickets opened and closed and indicate any trending issues by the third (3rd) business day of every month.

Deliverable:

A. Help Desk Executive Summary Reports

5.6 OPTIONAL TASK: REFRESHER TRAINING

The Contractor shall provide refresher training to VISN 21 users on both virtual (can be online or telephonic). A majority of the refresher training is anticipated to be conducted virtually. If virtual refresher training is requested, the request can originate from users from any of the VA facilities under this contract.

At the time the COR determines the on-site training is needed, the COR will coordinate with the Contractor for one (1) on-site refresher training. The on-site refresher training shall be a virtial session that will present training materials generated under Section 5.3.6. This on-site refresher training is targeted for newly assigned VA employees at these VAMCs. This on-site refresher training class is not expected to have more than 10 students.

For this optional task, the total anticipated number of training hours (including both virtual and on-site training class) shall not exceed 40 hours.

5.7 OPTION PERIOD

5.7.1 OPTION PERIOD 1

If the Option Period 1 is exercised by VA, the Contractor shall perform all tasks identified in Sections 5.1, 5.1.1, 5.3 through 5.5.

6.0 GENERAL REQUIREMENTS

6.1 ENTERPRISE AND IT FRAMEWORK

6.1.1 VA TECHNICAL REFERENCE MODEL

The Contractor shall support the VA enterprise management framework. In association with the framework, the Contractor shall comply with OIT Technical Reference Model (VA TRM). The VA TRM is one component within the overall Enterprise Architecture (EA) that establishes a common vocabulary and structure for describing the information technology used to develop, operate, and maintain enterprise applications. Moreover, the VA TRM, which includes the Standards Profile and Product List, serves as a technology roadmap and tool for supporting OIT. Architecture & Engineering Services (AES) has overall responsibility for the VA TRM.

6.1.2 FEDERAL IDENTITY, CREDENTIAL, AND ACCESS MANAGEMENT (FICAM)

The Contractor shall ensure Commercial Off-The-Shelf (COTS) product(s), software configuration and customization, and/or new software are Personal Identity Verification (PIV) card-enabled by accepting HSPD-12 PIV credentials using VA Enterprise Technical Architecture (ETA), https://www.ea.oit.va.gov/EAOIT/VA_EA/Enterprise_Technical_Architecture.asp,…