STATEMENT OF WORK v.2.docx

STATEMENT OF WORK

Ralph H. Johnson VA Medical Center, Charleston SC Department of Pathology & Laboratory Medicine Services

Title: Data Innovations Instrument Manager Upgrade and Autoverification Services Definitions:

Interface- shared boundary across which two separate components of a computer system exchange information HL7 Interface- Health Level 7 refers to a set of international standards for transfer of clinical and administrative data between Hospital information systems. These standards focus on the application layer, which is "layer 7" in the OSI model. The HL7 standards are produced by the Health Level Seven International, an international standards organization, and are adopted by other standards issuing bodies such as American National Standards Institute and International Organization for Standardization Government focused Information Technology Value Added Reseller (ITVAR) built for the purpose of delivering high quality products and ancillary services to the Federal Government.

Data Innovations – a laboratory middleware company, which allows for the transmission of patient or quality control results from laboratory instrumentation to the patients’ medical record.

Instrument Manager- Data Innovations software which provides functionality within the middleware for a variety of laboratory operations.

Autoverification- the process of using computer-based rules to verify clinical laboratory test results without any manual intervention.

GENERAL INFORMATION:

Statement of Work:

The Ralph H Johnson VA Medical Center Laboratory is seeking to procure the services of upgrading our existing laboratory middleware, Data Innovations, for the purpose of autoverification of quality control and patient results to the medical record, advanced rule writing professional services to deal with unusual and unexpected results, and any additional service and maintenance of the upgraded Data Innovations Instrument Manager. Instrument Manager is used currently as middleware between laboratory instruments and the hospital’s LIS for interface connectivity. The Data Innovations Instrument Manager middleware software is already validated, and on site at the hospital’s laboratory main facility.

Scope of Work:

The contractor shall provide all the resources required to deliver the requirements stated herein, except as may otherwise be specified in this statement of work.

1. PROFESSIONAL SERVICES

1.1. Description of Professional Services.

Data Innovations will perform the following Professional Services under this SOW:

· Install the latest released version of Instrument Manager™ (“IM”) onto Customer provisioned IM production, hot backup, reports, and test servers and assist with database and soft license migration as needed

· Assist with archiving setup on IM production server

· Assist with installing IM Thin Client application on identified workstations

· Assist with User Security setup

· Assist with interfacing of Vista test system with IM test system

· Assist with the installation and setup of the nationally approved VistA Auto-Verification drive

· DI will assist with configuration and connectivity of the following two (2) Microbiology Instruments with the existing core Instrument Manager and Vista LIS:

· bioMerieux MYLA

· Copan WASP

· DI will assist with configuration and connectivity of the following Blood Bank Instrument with the existing core Instrument Manager and VBECS LIS:

• Immucor ECHO (or similar replacement blood bank instrument)

· DI will provide up to a total of 24 hours of dedicated Go-Live support for all instruments listed above.

· Assist with setup and testing of CAP eLSC connection

· Design and implement Auto-Verification (AV) Rule Sets for five (5) unique Low Complexity instrument Workflows listed above based on data provided from lab standard operating procedures (“SOPs”), which may include one or more of the following categorical rules types:

· Provide tutorial on Rule Set maintenance

· Provide tutorial on creation and execution of test cases within the IM rules engine

· Provide guidance on rules validation techniques and assist with troubleshooting and/or modifying rules, as needed, during the validation phase

· Assist with creation and customization of Specimen Management workspaces to manage test results

· Provide up to fifteen (15) days of dedicated go-live assistance for AV (3 per AV workflow)

· Assist with setup of Laboratory Intelligence report server

· Configure up to six (6) Laboratory Intelligence widgets which capture and display desired Auto- Verification performance metrics

· Provide tutorial on Laboratory Intelligence

1.2. Term of SOW. The term of this SOW shall be as set forth below and shall continue unless earlier terminated pursuant to the termination terms and conditions set forth in the Agreement.

Open Term: The term of this SOW shall begin upon the Effective Date and shall continue until all Professional Services are completed.

1.3 Professional Service Considerations.

1.3.1. Hardware required to support this project has been provisioned or in-process including four (4) required IM servers meeting DI Hardware Sizing Recommendations, attached hereto as Exhibit 1, including IM production, IM test, IM hot backup (or IM high availability), and IM reports servers

1.3.2. Performance of the Professional Services requires that Business Partner Customer is current on all Maintenance and Support Services fees for all existing and new DI Software licenses. Data Innovations will not be able to schedule the start of the Professional Services until the current/active status of Business Partner Customer’s Maintenance and Support Services has been confirmed

1.3.3. Period of Performance (PoP) from contract signing is estimated to be up to 24 Months duration, which includes a two-month lead time for DI Resource assignment. The estimate assumes one Laboratory Information Manager (LIM) resource will be assigned to the project to lead tasks for each milestone listed in section 1.5. See milestones with estimated timelines listed in section 1.5 for more detail. Additional tasks maybe required based on License Customer’s specific installation. Data Innovations and Business Partner will discuss and mutually agree in writing to any additional tasks prior to performance by Data Innovations.

1.4. Work Product.

1.4.1. Installation of IM production, IM Disaster Recovery (or High Availability as licensed), IM Reports and IM Test instances onto new Customer-provided servers (as required)

1.4.2. Connectivity of the two (2) Microbiology Instruments as detailed in section 1.1

1.4.3. Connectivity of the one (1) Immucor Blood Bank instrument with VBECS LIS as detailed in section 1.1 (or current blood bank instrument)

1.4.4. Up to a total of twenty-four (24) hours of go live support for the Microbiology and Blood Bank instrument connectivity described in section 1.1

1.4.5. Development and implementation of five (5) unique Low Complexity instrument Workflows as detailed in section 1.1

1.4.6. Specimen Management workspaces configured for reviewing rules-held results on instruments configured for Auto-Verification

1.4.7. Tutorial on Rules maintenance, rules testing techniques, and Specimen Management workspaces

1.4.8. Remote Testing and Troubleshooting support in preparation for go-live

1.4.9. Laboratory Intelligence server configured with up to six (6) Auto Verification performance indicators (KPIs)

1.4.10. CAP eLSC connection for proficiency test reporting

1.4.11. Up to fifteen (15) days of remote or onsite go live support (3 per AV workflow)

1.5. Estimated Chronology

1.5.2. Milestone 2 – Microbiology Instrument Connectivity: 4-6 weeks*

1.5.3. Milestone 3 – Blood Bank Instrument Connectivity: 2-4 weeks*

*note: timeline dependent on factors including workflow complexity and resources

1.5.4. Milestone 4 - Auto Verification Build and Deployment for Low Complexity Workflow 1: 8-12 weeks*

1.5.4.8. Customer performs Autoverification system testing between instrument(s), IM, and VistA LIS

1.5.4.9. DI IM Technical Specialist assists with troubleshooting issues and rules adjustments as required

1.5.5. Milestone 5 - Auto Verification Build and Deployment for Low Complexity Workflow 2: 8-12 weeks*

Workflow 3: 8-12 weeks*

1.5.6.1. Autoverification rules kick off meeting

1.5.6.2. Complete Autoverification rules data collection activity

1.5.6.3. DI IM Technical Specialist builds/adapts Autoverification rules

1.5.6.4. DI IM Technical Specialist deploys rules onto IM test Server

1.5.6.5. Rules review and tutorial with local IM administrator(s)

1.5.6.6. Begin rules validation testing

1.5.6.7. Update rules as required during initial testing

1.5.6.8. Customer performs Autoverification system testing between instrument(s), IM, and VistA LIS

1.5.6.9. DI IM Technical Specialist assists with troubleshooting issues and rules adjustments as required

1.5.6.10. Customer completes required SOPs for Autoverification workflow

1.5.6.11. Customer trains lab end users on Autoverification workflow

1.5.6.12. Customer plans go-live of IM with instrument Autoverification rules with VistA LIS

1.5.6.13. Go-live IM with Autoverification rules with VistA LIS *note: timeline dependent on factors including workflow complexity and resources

1.5.7. Milestone 7 - Auto Verification Build and Deployment for Low Complexity Workflow 4: 8-12 weeks*

1.5.8. Milestone 8 - Auto Verification Build and Deployment for Low Complexity Workflow 5: 8-12 weeks*

1.5.9. Milestone 11 - Laboratory Intelligence: 4-8 weeks

1.5.10. Milestone 12 - CAP eLab Solutions Connect: 2-4 weeks

1.6. Site Readiness Checklist.

1.6.1. IM Servers are provisioned and configured on the Customer’s LAN for communications with the LIS and Instruments on the network

1.6.2. Vista LIS Instrument Manager interfaces are configured and ready to communicate with new IM servers

1.6.3. Instruments are configured to communicate to IM on the network

1.6.4. A technical resource is available with local admin privileges on the IM servers and IM thin client computers to facilitate successful installation of IM software

1.6.5. Remote/VPN/RDP connectivity to new IM Servers established by network administrator and verified by DI IM Technical Specialist

1.6.6. Access control lists (“ACLs”) in place as needed for inter-server network TCP/IP communication between above servers, from servers to Thin Clients, and from servers to all instruments selected for this project are in place or in-process

1.6.7. Vista LUI v1.6 interfaces on latest patch to support Auto-Verification are in place

1.6.8. Validation testing shall be performed in a Vista Test with IM Test environment and requires that the Vista Test System Lab Build Mirrors Vista Production System prior to Validation Testing

2. BUSINESS PARTNER RESPONSIBILITIES. Business Partner shall be, or where applicable shall require the Business Partner Customer to be, responsible for the following:

2.2. Assigning an individual to act as the primary point of contact with respect to the Professional Services.

2.3. Issuing a purchase order for estimated Billable Expenses to Data Innovations, in advance of any agreed upon travel or expenditure.

2.4. Providing Data Innovations, at no charge, with reasonable workspace, administrative support, access to necessary facilities and equipment, computer time on computers, office space if necessary, and other support as necessary for Data Innovations to perform the Professional Services.

2.5. Performing and/or providing in a timely fashion the tasks and personnel set forth in this section.

2.6. Assigning personnel to work on the matters related to the Professional Services that are qualified for the tasks for which they are assigned.

2.7. Cooperating with Data Innovations in providing prompt and timely information, notices, and feedback as is necessary or desirable hereunder.

3. RULES-BASED SERVICES. As part of the Professional Services provided under this SOW, Data Innovations may provide Rules-Based Decision Processing services (“Rules-Based Services”) which can include:

to any algorithms, or their content, implemented via its Rules-Based Services.

4. DATA INNOVATIONS RESPONSIBILITIES. Data Innovations will be responsible for the following:

4.1. Provide a Data Innovations Technical Resource(s) to accomplish the services described in Section 1 of this Statement of Work

4.2. Services to be performed during normal DI business hours (8:30am – 5:00pm E.T. if remote, or local time if on site)

5. FEES, INVOICING AND PAYMENT TERMS. In consideration for the Services provided by DI to Customer under this SOW, Customer (or a third-party on their behalf) will compensate DI for the Service Fees set forth in the Quote #106996 (the “Quote”) as follows:

5.1. Implementation Projects: 100% of fees (total or residual) upon completion of the Services or according to the following schedule, whichever occurs first:

5.1.1. Total Service Fees between $100,001 and $1,000,000: eight (8) 12.5% installments billed in consecutive quarters starting one-hundred and twenty (120) calendar days after Award Effective Date

7. RECORDS MANAGEMENT OBLIGATIONS

A. Applicability

This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions “Federal Record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

1. includes [Agency] records.

2. does not include personal materials.

3. applies to records created, received, or maintained by Contractors pursuant to their [Agency] contract.

4. may include deliverables and documentation associated with deliverables.

C. Requirements

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. RHJ VAMC and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of RHJ VAMC or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to RHJ VAMC. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to RHJ VAMC control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

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

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with RHJ VAMC policy.

8. The Contractor shall not create or maintain any records containing any non-public RHJ VAMC information that are not specifically tied to or authorized by the contract.

9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

10. The RHJ VAMC owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which [FACILITY] shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

D. Flow down of requirements to Subcontractors

1. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

2. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.

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