Statement_of_Work_Laboratory_Information_Systems.pdf

National Institutes of Health Statement of Work-i Laboratory Information System – Hardware, Software and Maintenance

Attachment 1

Description/Specifications/Statement of Work

Table of Contents

Attachment 1 .................................................................................................................................................. i Description/Specifications/Statement of Work .............................................................................................. i Project Title: ............................................................................................... Error! Bookmark not defined.

Part I – General Information 1 Background Information Part II - Requirements 2 General Requirements

2.1 Scope and Objectives

3 Maintenance and Support Requirements

3.1 General Maintenance Requirements

3.2 Responsibilities of the Offeror

3.3 Responsibilities of the Government

3.4 Maintenance Facilities for the Offeror

3.5 Maintenance

3.6 Non-Chargeable Maintenance Items

3.7 Software Enhancements/Updates

3.8 Interface Maintenance

3.9 Terminology Maintenance

3.10 Documentation Maintenance

3.11 Development Maintenance

3.12 Maintenance Period

4 Other Requirements............................................................................ Error! Bookmark not defined.

4.1 New Modules, Hardware, Features, Training, and services

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Laboratory Information Systems - Hardware, Software and Maintenance

Part I – General Information

1 Background Information

The mission of the National Institutes of Health (NIH) is to uncover new knowledge that will lead to better health for everyone. The NIH accomplishes that mission by conducting research in its own laboratories;

studying patients enrolled in formally approved research protocols conducted within the Clinical Center;

supporting the research of non-Federal scientists in universities, medical schools, hospitals, and research institutions throughout the country and abroad; helping in the training of research investigators; and fostering communication of biomedical information.

As an organization, the NIH is a unique medical research entity. Management is intentionally decentralized across 24 Institutes and Centers, yet the individual organizations cooperate and collaborate in a useful and necessary partnership. This controlled decentralization is expected to continue as most feel it provides a fertile environment for individual research and supports the incredible scientific diversity represented at

NIH.

The Warren Grant Magnuson Clinical Center, a 200-bed, federally funded, biomedical-research hospital, is located on the NIH campus in Bethesda, Maryland. The Clinical Center is the delivery setting for all NIH intramural clinical research protocols. The Clinical Center accounts for about half of all NIH-funded clinical research beds in the United States. Patients are admitted to the Clinical Center for the sole purpose of participating in clinical research protocols. Patients may be self referred or referred by their local physicians. The Clinical Center admits patients from all over the world for clinical trials and natural history studies, with all care provided free of charge. The Clinical Center accommodates about 7,000 inpatient admissions and 70,000 outpatient visits a year. The new Clinical Research Center (CRC) was completed in September 2004, which includes all new inpatient and day hospital units.

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Part II - Requirements

2 General Requirements Independently, and not as an agent of the Government, the Offeror shall furnish all necessary software, labor, materials, supplies, equipment, and services (except as otherwise specified herein) and perform the work set forth below. The Project Officer shall monitor all work performed under this contract.

2.1 Scope and Objectives

The National Institutes of Health Clinical Center’s requirement is for an Offeror to provide the following:

2.1.2 Ongoing maintenance and support services

The vendor shall provide maintenance and support for the following software modules in use or currently under implementation at the Clinical Center as well as any modules purchased and installed through the life of this contract.

SoftPathDX

SoftPathDx provides reliable data capture as well as a highly customizable and client configurable reporting and workflow structure for both anatomic pathology and cytology. A diverse imaging and reporting system allows a personalized setup. SoftPathDx also enables users to share specimens between other labs such as biochemistry, flow cytometry, cytogenetics, and molecular. This allows for integrated resulting and the ability to track specimens throughout multiple labs. SoftPathDx also enables users to optimize workflow by focusing on site-specific protocols and rules to assist the technologists and pathologists in decreasing turnaround times and managing patient data.

SoftBank

SoftBank is a Blood bank and transfusion service management system combines current high-performance functionality with exciting new features to provide a comprehensive, cost-effective pre-transfusion testing and inventory management solution.

SoftLAB

SoftLab computerizes and manages all data processing and laboratory activities, from order entry and result reporting to interfacing with laboratory instruments. The fully integrated SoftLab system provides a seamless interface that links all clinical laboratory departments throughout the enterprise.

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SoftMic

When managing microbiology specimens requires a high-tech solution, SCC’s SoftMic is the answer. If you’re seeking a paperless environment, you’ve got it! SoftMic automates the processing of specimens through all stages, from order entry and workup to final reporting – offering a high-tech paperless solution with on-demand work cards, result entry, and flexible reporting capabilities that can substantially improve testing accuracy and report uniformity.

With its seamless operation and automated batch resulting, SoftMic can customize workflow in any environment, increase productivity, improve efficiency, and minimize errors providing real-time patient results and point-of-care quality.

When SoftMic is integrated with SoftLab™ and other SCC information systems, common data flows effortlessly throughout the system, increasing productivity and minimizing systems operating costs.

SoftTotalQC

SoftTotalQC is a multisite capable product developed to facilitate and analyze quality control in the clinical laboratory setting. Quality control activities can be defined and documented on controls, reagents, media, panels, drugs, consumables, and maintenance procedures on equipment. Along with quality control, SoftTotalQC provides an inventory control solution allowing each department and site to maintain their supply of controls, reagents, media, panels, drugs, and consumables.

SoftTotalQC is fully integrated with SoftLab®, SoftMic®, SoftBiochemistry®, SoftFlowCytometry®, SoftMolecular®, SoftCytogenetics®, and SoftHLA®, enabling users to perform QC checks before patient results are posted or entered. This allows QC results to be posted from instruments or be manually entered within patient resulting workflow and provides an automatic inventory countdown for related QC items. SoftTotalQC can be used in all other departments of the laboratory as a standalone product.

SoftTotalQC, assuring quality through total quality control management.

SoftReports

SoftReports provides enhanced report capabilities allowing users to incorporate color, a variety of report fonts, images, graphs, and charts. This add-on report engine can be integrated with SCC’s product suites enabling users to create new report layouts and modify existing layouts.

SoftReports offers a wide range of formatting options including PDF, HTML, XLS, and RTF.

SoftWebPlus

SoftWebPlus, SCC Soft Computer’s computerized physician/provider order entry/result query solution, is the enterprise healthcare Web solution designed to give the physician and other responsible medical staff real-time access to clinical results, effective tools for outreach management, and fast and user-friendly order entry and patient registration.

SoftMedia

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SoftMedia provides users a pragmatic method for enhancing clinical services with document and image storage capabilities. SoftMedia gives clinical personnel the ability to attach stored documents or images to specific orders and other patient records.

SoftMedia enables users to attach digital images to reports, which optimizes communication and improves the quality of services provided by supplementing images with online annotation.

Features include multi-system document sharing, so documents and images stored in one system can be made available to users in other systems. This flexible software application works seamlessly as a standalone product or in conjunction with any of SCC’s information systems modules.

SoftID

SoftID provides positive patient and specimen identification at the point of care. This effective lab software solution enhances patient safety by accurately identifying the patient and the appropriate lab test and ensuring that patient lab specimens are correctly bar coded and labeled.

SoftID improves laboratory efficiency by automating the documentation of specimen collection data. When the collection is complete, SoftID will transmit data back to the LIS for real-time updates.

SoftID.Tx

SoftID.Tx, the positive patient identification system from SCC Soft Computer, is a comprehensive system used to manage the transfer of transfusion-related data from the patient’s bedside to SCC’s SoftBank system. SoftID.Tx enables users to collect transfusion-related data, assign a blood product to a courier, and verify that the product selected for transfusion is the same product assigned to the patient in SoftBank

SoftFlowCytometry

SoftFlowCytometry enables pathologists and medical technologists to effectively analyze multiple parameters from flow cytometric analysis software, including imported histograms and scatter plot images and data from custom panels derived from flow cytometry analysis techniques. The net result is better design configurations in testing workflows, task management, and result reporting. SoftFlowCytometry can be readily interfaced with virtually any flow cytometry instrument or data analysis platform for capture of large volume information analysis and management. Interfacing supports an efficient laboratory workflow avoiding manual entry that increases risk for data entry error. Efficiency and accuracy gains offered by SoftFlowCytometry will ensure that your laboratory can grow rapidly without requiring additional personnel or negatively impacting quality.

SoftBI

SoftBI is a data analytics and visualization application for hospitals and clinical laboratories of all sizes. This business intelligence solution enables users to integrate administrative data for

National Institutes of Health Statement of Work-7 management reporting, trending, and research. SoftBI also supports activities such as staffing and pricing.

SCC’s complete line of business intelligence products will include a full suite of interactive drill-down style reports that provide critical operational data, analytical and statistical data, laboratory efficiency data, various productivity analyses, and other reports involving data from all of SCC’s core software products.

The vendor shall provide Operational Support Services including but not limited to the below:

· Background monitoring of production environment and downloading of operating system files that provides warning messages and resource utilization statistics.

· Diagnosis of problems and directing of in-house staff. Domain expertise in all areas of software application modules and system engineers in stabilizing production environment or contacting original equipment manufacturer (IBM) for component repair and operating system situations.

· Establishing a stable transition environment if necessary by switching all critical functions, devices and interfaces from primary system to auxiliary system yet addressing full production under limited capacity. Switch back to dual configuration upon completion of repair.

• · 24 Hours/7 days a week service for all of the above which means full coverage for off-hours. · Repair of relational-network database libraries, indices and data files as a result of power fluctuation or hardware malfunctions.

· Recovery from backup tapes as a last resort.

• The vendor shall provide OEM Hardware support and services in support of the hardware currently installed at the CC or may be installed through the life of the contract.

· This service is provided by IBM. This service covers onsite repair/replacement of failed internal CPU component, and external component manufactured and covered by IBM.

· Please note this service only covers the hardware component of IBM CPU and component repair and replacement, and does not cover AIX support and service.

· This service suite only covers component repair and replacement.

OEM ORACLE AND DB_VISTA DATABASE ADMINISTRATION SUPPORT

Initial database installation and setup Database upgrades Ongoing database maintenance Database monitoring Problem determination and resolution Database backup, recovery and failover.

Database performance tuning

The vendor shall maintain the current interfaces for the lab equipment that communicates with the lab system as well as replacement lab equipment through the life of the contract.

CellDyne 3700 Dade Behring BN II

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IL GEM 4000

LASC

Ortho Provue

ABL 835

ABL 835

Bactec 9000 Blood Bank to Carefusion -Uni Outbound Interface Dimension Xpand

EXCYTE 40

EXCYTE 40

I-STAT

Immulite 2000 DPC Iris IQ200 Organon BacTalert Ortho ECiQ ANalyzer Phoenix through EpiCenter Data Manager Revelation DSX ELISA Roche Elecsys 2010 Stago Evolution Stago Evolution Vista Vista

XE5000

XE5000

Inbound HL7 Order Entry, SoftLab/Mic/BB[TDS] Enhancements to AP Enhancements to BB POC - Blood-Gas POC - Chemistry POC - Coagulation POCT- Bedside Testing Instrument Processor POCT- Hematology Ref Lab Interface (per Lab) Enhancements to AP Enhancements to BB Outbound HL7 Order/RR, SoftLab/Mic/BB to Eclipsys Outbound HL7 RR, SoftPath to Eclipsys Doctor Update Interface Phlebotomy (Blood Bank to Carefusion-Uni. Outbound Monthly Database Administration and Recovery (Oracle) SCC Required VSI_FAX v5.1.0 RISC server W/maintenanceWith Attachments for up to 4 Modems SCR - Would likee to add two new lines to that PAD and FAD template. Wwould like to have "NIH inpatient death?" & "extent of permission" added just below the clinical diagnosis area.

SCR, NIH-02204

Abbott Commander FPC Abbott Sapphire Abbott FLX Abbott FLX PhD Uni-Directional Instrument Interface by Helix Roche Cobas Fara Microscan SoftReports Reporting Module/Active Reports Outbound HL7 ADT, SoftLab to HistoTrac through QDX

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Management Report Suite Inbound HL7 Result Posting, HistoTrac to SoftLab QDX Bi-directional HL7 OE, SoftLab to HistoTrac through QDX Roche Data Manager Cobas 6000- c501 Cobas 6000- e602 Sysmex Cellavision HL7 (RR SCC to BBCS)- Blood Bank Computer Systems HL7(OE HIS) [BBCS- Blood Bank Computer Systems] Cell Dyne 3700 Ventana Interface for PATH Ventana Interface for PATH Ventana Interface for PATH Cell Dyne 3700 Roche c501 module Roche c501 module Roche E601 module Roche E601 module Roche c501 module Roche E601 module Modular Pre-Analytics SoftWeb Ventana - LAB BioRad D-10 Hemoglobin Testing Radiometer America ABL825 Radiometer Radiance DM Diasorin Liason Trek SensiTitre Sysmex SP100 SP-1000i Sysmex XN123 XN1000 module for XN3000 XN1000 modul Sysmex XN123 XN1000 module for XN3000 XN1000 module Roche Data Manager Shurmark Cassette Labeler SoftMedia SoftMedia Customization Standard Bidirectional HL7 (Lab to GeneDx Siemens Advia 120 Siemens Advia 120 SoftID SoftID.Tx Weblogic ThermoFisher Slidemate ThermoFisher Slidemate SoftBI Thermo Scientific Printmate ES Ortho clinical Diagnostics Vision MRV 16 Port Xyplex MRV 16 Port Xyplex MRV 16 Port Xyplex MRV 16 Port Xyplex MRV 8 Port Xyplex MEI Electrical Interface (MEI) serial-to-Ethernet connectivity in four-port model

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2.1.3 Electronic and Information Technology Accessibility Standards As set forth in Section 508 amendments of the Rehabilitation Act, the following Electronic and Information Technology Accessibility Standards (36 CFR Part 1194) are applicable to this contract:

(a) Section 1194.21 – Software Applications and Operations Systems Technical Standard.

(b) Section 1194.22 – Web-based Intranet and Internet Information and Applications Technical Standard.

(c) Section 1194.31 – Functional Performance Criteria Technical Standard.

(d) Section 1194.41 – Information, Documentation, and Support Technical Standard.

These standards may be found at http://www.section508.gov/final_text.html.

3 Maintenance and Support Requirements

3.1 General Maintenance Requirements

The Offeror shall provide maintenance for the system application software as specified in this contract.

The Offeror shall provide Service Level Agreements (SLAs) or published service standards to meet the maintenance terms and conditions. The SLAs shall address, but are not limited to the following elements:

Service policies and procedures including security and software support, on call/on site service priorities, thresholds, response time, resolution/fix time, reporting and escalation procedures.

The Offeror shall grant, in accordance with the terms and conditions contained in this contract, a non-exclusive, irrevocable and perpetual license to use the Software. This includes custom software products, e.g., interfaces, developed by the Offeror; custom software products will remain the intellectual property of the Offeror, but will be perpetually licensed to NIH under the same terms as the generally released software products.

3.2 Responsibilities of the Offeror

The Offeror shall provide maintenance for the system application software at the prices shown in the Cost Proposal, including all necessary maintenance labor, repair parts, maintenance supplies, tools/utilities, test equipment, transportation, software, documentation and other related supplies and services as may be required to keep the system in good operating condition at the availability level of at least 99.5% as defined in Section 4.1. The system and all components delivered under this contract must maintain the Effectiveness Level for the duration of the contract or the contract may be terminated for default.

The average effectiveness level for a system/item of hardware is a percentage figure determined by dividing the total productive operational use time for a system/item of hardware during a given period by the sum of that total productive operational use time plus the functional failure downtime of that system/item of hardware during the same period of performance.

A System Problem or Functional Failure means that the system/item of hardware or software is considered "down", not operating, when, due to malfunction of hardware or software or systems software acquired under this contract, the system/item of hardware or software fails to perform to the manufacturer’s specifications and/or is not in compliance with all technical/performance requirements in the contract.

http://www.access-board.gov/news/508-final.htm

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Average Effectiveness Level =

100 x Productive Operation Use Time__________

Productive Operational Use Time + Functional Failure Downtime

The Offeror shall provide maintenance on all software that are proposed and accepted by the Government.

The software to be maintained includes all of the Application Software delivered during the duration of this contract and other software that enhances the application operation. The Offeror shall fully support such software, including any Offeror-sponsored modification or revisions thereof, at no additional cost, unless specified in the Cost Proposal, for the duration of this contract, including the exercise of options.

All services under this contract shall be performed by fully trained and technically experienced personnel providing the required services in accordance with the best commercial practices without unreasonable delays or interference with Government functions. Use of trainee personnel for maintenance services on this contract shall not be allowed, except when accompanied and supervised by trained, experienced personnel capable of satisfying the support requirements of this contract.

The Offeror personnel, assigned to provide support under this contract, shall be fully capable technicians possessing the technical skills necessary to monitor, control, and perform the requirements of the statement of work. If Original Equipment Manufacturer (OEM) warranties require OEM certification of maintenance personnel, the Offeror shall supply personnel who are so certified.

Maintenance shall include any repairs to failures resulting from ordinary use. Maintenance shall not include repairs for damage resulting from Government accident; transportation by Government between Government sites; Government negligence; Government misuse; failure of electrical power, or air-conditioning or humidity controls; or other causes that are not the result of ordinary and/or reasonable use.

While the Offeror’s personnel are at the Government facility, the Offeror is responsible for compliance with all laws, rules and regulations governing conduct with respect to privacy, health and safety not only as they relate to its employees and agents.

Only new standard parts, or parts equivalent to new in performance, that meet the OEM specifications when used in the equipment shall be used to effect repairs. If a part is not new, it shall be identified to the Government as warranted as new. Maintenance parts shall be furnished on an exchange basis. The new parts become the property of the Government and replaced parts shall become the property of the Offeror.

In no case shall the Offeror use any replacement parts in repairing equipment that would result in the OEM refusing to support the equipment. A warranty shall be provided for all replacement parts. Parts shall not be swapped or exchanged between hardware components without prior approval from the Contracting Officer or his/her designee. There shall be no additional charge for replacement parts unless such parts are necessary due to the fault or negligence of the Government or its agents as determined by the Government.

Maintenance service shall not include electrical work external to the equipment, the furnishing of consumable or operating supplies other than maintenance supplies, and adding or removing accessories, attachments, or other devices placed by the Government.

Changes to maintenance resulting from Government alterations to the Offeror-supplied Hardware or Software shall be the subject of mutual agreement. Any failure to agree shall be resolved pursuant to the Disputes Clause.

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Offeror-sponsored alterations or attachments to Hardware or Software shall be made only with the consent of the Contracting Officer.

3.3 Responsibilities of the Government

Subject to security regulations, the Government will provide the Offeror access to the system and any other components needed to perform the required preventive or remedial maintenance service.

The Government will provide a time for installation of approved Offeror-sponsored modifications within a reasonable time after being notified by the Offeror that the modification is ready to be made. The time required to make the modification shall be outside the principal period of maintenance as defined in Section 3.5, unless another time is mutually agreeable.

The Government will maintain site requirements in accordance with the equipment environmental specifications furnished by the OEM.

Government personnel will neither perform maintenance nor attempt repairs, other than those stated in the Offeror’s maintenance plan, to Hardware and Software while the Offeror is maintaining the system.

The Offeror shall have the right to inspect Government Owned Equipment (GOE) for maintainability and safety prior to accepting the maintenance responsibility. The inspection of such equipment shall be provided at no cost to the Government.

The government shall provide hardware maintenance on any hardware obtained prior to the acceptance of this contract. All hardware purchased under this contract shall include 3 year 24x7x365 4 hour response time warranty. The government shall have the option to obtain 3rd party OEM hardware maintenance after the manufacturer warranty expires.

3.4 Maintenance Facilities for the Offeror

The Government will provide adequate storage space for spare parts and adequate working space, including heat, light, ventilation, electric current and outlets, and telephones for the use of maintenance personnel. These facilities shall be within reasonable distance of the equipment to be serviced and shall be provided at no charge to the Offeror.

3.5 Maintenance

The commencement date shall be upon establishment of this contract.

The Offeror shall provide a fully functioning help desk function available at the Offeror site via telephone during the Principal Period of Maintenance (PPM) which shall be Monday through Friday 8AM to 5PM excluding holidays. The Government reserves the right to change the PPM upon 60 days written notice.

Any changes in the cost due to the change in the PPM shall be subject to mutual agreement.

In addition to the maintenance service during the stated PPM (or extensions thereof), on-call maintenance shall be provided via to an experience technician/analyst outside the PPM.

The Offeror shall provide a contact number for placing on-call requests on a 24-hour, 7 days/week, 365-days/year basis, including holidays, for receipt of management and first line support of system problems regardless of cause. The Offeror shall make arrangements to enable its maintenance representative to receive such notification.

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All calls to the Offeror point of contact shall be logged on a Problem Log and categorized using a category list defined by NIH and the Offeror. The following categories should be considered:

* System enhancement

* Manual workaround

* System Degraded

* System Down

* Updates

* Fixes - permanent,

* " built as designed"

* Critical Problems

The Problem Log shall be accessible by the Government electronically and be searchable by type of problem to find information about problem, problem status and resolution.

The Offeror shall respond by phone with an appropriate technically qualified person within one (1) hour of the Government's request for service.

If the problem is determined to not be caused by Offeror-provided hardware, software, operating system or third party tools, the Offeror shall provide information on potential source of problem and rationale for source identification to designated system administrator.

The Offeror shall respond to a Production System Problem (hardware or software) with appropriate technically qualified person within one (1) hour of the time the Government contacts the Offeror’s point of contact. The Offeror shall provide on site problem resolution at no additional costs if deemed necessary by the Government.

Software related problems not resulting in Production System Problem, shall be responded to by the Offeror within four (4) hours. Should the Government require maintenance service for such problems outside the designated PPM or on site, the Offeror shall respond with an appropriately qualified representative within twenty-four (24) hours. The hourly rates for such additional maintenance services and the maximum charge for any one occurrence shall be specified in the Cost Proposal.

The Offeror shall provide all fixes and patches to the Production System Problem occasioned by the maintenance call within forty-eight (48) hours of the maintenance call.

If the Production System is down or major portions of the system remain unavailable or patient safety is at risk, the Offeror shall provide the fix within two (2) hours of problem determination.

Problem Severity Respond to Call

Fix Problem On Site Problem Resolution

Production System Problem – patient safety at risk, production system down or major portions unusable

1 hour Within 2 hours of problem determination

Within 4 hours of determination

Production System Problem – 1 hour Within 4 hours of problem determination

Within 24 hours of determination

National Institutes of Health Statement of Work-14 major portions of system usable and mission critical workload can continue Production System Problem – system usable with manual workaround

1 hours Within 48 hours of problem determination

Non-production System Problem 4 hours Within 48 hours of maintenance call

Summary of Problem Severity and Response Times

The Offeror shall provide the option to access the system remotely to review and repair system malfunctions. Such remote services shall be done in a fashion to maintain the security of the system and the integrity and confidentiality of the patient information and shall adhere to NIH security procedures.

If the maintenance representative determines additional assistance, hardware or software is necessary from an OEM to correct a malfunction that has not been corrected, the Offeror shall promptly provide such assistance at no additional cost to the Government.

The Offeror shall provide follow-up with written Malfunction Reports, as described in Section 3.6, on all problem calls submitted by the Government, including acknowledgement of receipt and preliminary response to non-Production System Problems within one week of the call.

The Offeror shall provide an escalation procedure to address Production System Problems not corrected within forty-eight (48) hours of a maintenance call. The procedure shall provide for a response from an executive representative of the Offeror to a phone call from the Project Officer. The call shall develop a mutually agreeable plan and timeframe for Offeror’s plans to correct the malfunction and shall be followed by a written report within one day of the call. In the event that such malfunction is not corrected in the mutually agreed timeframe, an appropriately qualified representative shall be dispatched to the Government site and remain at the Government site until such matters have been resolved, at no additional cost to the Government.

3.6 Non-Chargeable Maintenance Items

There shall be no additional charges for the following:

• Replacement parts, unless such parts are required due to the fault or negligence of the Government;

• Software fixes and patches necessary to correct Software or other Functional Failure Downtime events;

• Software enhancements or updates (releases) versions as made generally available to other health care provider clients;

• Preventive maintenance, regardless of when performed;

• On Call/On Site maintenance to correct critical problems or maintenance initiated but not completed within the PPM; or

• Time spent by Offeror’s maintenance personnel after arrival at the Government’s installation while not engaged in productive maintenance activities but waiting for the arrival of additional Offeror maintenance personnel and/or parts.

3.7 Software Enhancements/Updates

In the event the Offeror makes generally available modifications to its software that were developed to address present or future requirements for NIH, such modifications shall be provided to the Government at no cost. The Offeror also agrees to provide updated documentation, user guides, and technical bulletins necessary to implement, use, and support such modifications at no cost to the Government.

During the life of the contract, the Offeror shall also provide regular enhancements to keep its Software current with the latest versions of operating system and other related Software.

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The Offeror shall provide fixes and patches to software problems identified in maintenance calls or as provided to any other customers using the Software. If the fix or patch provided by the Offeror in response to a maintenance call is a permanent fix, then the Offeror shall provide a permanent correction of the errors and applicable documentation at no additional cost to the Government.

The Offeror shall provide the capability to allow Government to selectively implement fixes or patches to correct software defects.

The Government is not obligated to wait for a new software release to correct a software malfunction.

If the Government elects not to accept later versions of the Software, maintenance shall continue under the terms and conditions of the contract regardless of NIH production version. The Government’s decision to accept a new release will consider system impact, maintenance of customization, and documentation of stability of the new release.

The Offeror shall provide a structured mechanism (i.e., user groups, client focus groups, etc.) for soliciting input from NIH or from client user groups in which NIH participates on recommended product enhancements and updates.

The Offeror shall provide a response to any Government request for changes, submitted to Offeror in writing, within 60 days of receipt of such requests, at no additional cost. The Offeror’s response shall include the reason for rejection or notice of acceptance. Acceptance of such requests shall include development plans, priorities, cost and timing for making such enhancement/updates available to the Government.

The Offeror shall provide 30 days written notification of the release of any software modifications, improvements, updates, and revisions. In the case of new software level releases, the Government may elect to accept the later versions of the software, and if accepted, the Offeror shall provide software support at no additional cost during the period of this contract, including the exercise of any options.

The Offeror shall provide enhancements or improvements to ensure conformance to mandatory rules and maintain compliance with any Government regulation to which Government or general health care providers must adhere.

In the event enhancements or improvements, which alter the basic function of the Offeror-provided software, become available during the system life, the Government shall have the right to obtain such software application or component. The price(s) for such applications/components shall be no more than the lesser of (a) the price(s) then in effect or (b) the difference between the then current price of the application/component and the price paid for the application/component in the original contract. Software obtained under this provision shall be supported in accordance with the On Call/On Site Maintenance, Section 3.5.

3.8 Interface Maintenance

The Offeror shall provide updates/enhancements to, and maintain, interface-processing software that is compliant with approved HL7 standards within one year of HL7 standard approval.

If HL7 has a new release or if the upgrade system captures a new element for an existing interface, the Offeror shall specify and offer that enhancement needed to maintain the interfaces to operate and exchange interface specified HL7 data with the applications/components database provided under this contract.

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3.9 Terminology Maintenance

Terminology support shall include update and maintenance for standard terminologies, knowledge bases, and other supporting products provided under this Contract as licensed by NIH.

3.10 Documentation Maintenance

The Offeror shall provide full documentation of all Offeror changes and/or modifications to Software provided under this Contract. The Offeror shall provide the Government with all documentation required to enable the Government to successfully test and install new releases. The Offeror shall also provide corresponding updates to documentation required to operate and maintain the system for all application components, interfaces, or databases.

The Offeror shall update system documentation and provide corresponding support product documentation with each maintenance change to the Hardware and Software provided under this Contract.

3.11 Development Maintenance

The Offeror shall provide maintenance for any development deliverable to keep the development deliverable up-to-date with the current release of the Offeror-supplied system.

3.12 Maintenance Period

The Offeror shall provide ongoing support for the system for five (12-month) periods to be exercised at the discretion of the Government.

3.13 New Modules, Hardware, Features, Training, and services

During the contract period and upon the request of NIH, the contractor will provide fixed pricing for additional modules, hardware, new features, or upgrade assistance for the Soft system. The pricing shall include software licensing, applicable hardware and database costs, annual maintenance, implementation and training fees. The contractor will also provide hourly pricing for additional fee for service work that may arise during the contract period. Examples include but are not limited to; additional hours for required for upgrades, implementations, services for fee based case resolution or code customization. NIH will provide detailed SOW(s) for any new requests. The SOW will include both technical and functional requirements and any other details specific to those SOWS.

3.13 New Modules, Hardware, Features, Training, and services