SOW-Softbank_Validation_Services.pdf

NIH Clinical Center

SCC Interface for CCMD Stat Laboratory

Statement of Work

- 1 -

Background

The mission of the National Institutes of Health (NIH) is to uncover new knowledge that will provide hope through pioneering clinical research and improve health for everyone.

The NIH accomplishes that mission by conducting research in its own laboratories;

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.

The NIH Clinical Center (CC) is a 234-bed federally funded, biomedical research hospital located on the NIH campus in Bethesda, Maryland. The CC is the delivery setting for all NIH intramural clinical research protocols. The hospital complex consists of two main facilities that are connected to each other by “bridges”. The original 14-story building is 2.5 million square feet and continues to house the clinical laboratories, imaging sciences, surgical suites, and several outpatient clinics. The new 870,000 square foot facility houses inpatient units and day hospitals. The CC accounts for about half of all NIH-funded clinical research beds in the United States and accommodates about 7,000 inpatient and 70,000 outpatient visits a year. Patients are admitted to the NIH Clinical

Center from all over the world for the sole purpose of participating in a clinical research protocol.

The Department of Transfusion Medicine (DTM), established in 1953, provides high quality patient care and hospital services in support of NIH clinical research programs, pursues research that contributes to our knowledge and practice of transfusion medicine and related technologies, and provides advanced training in transfusion medicine. In addition to patient services, the physician, nursing, medical technologist and scientist groups comprising the department are actively involved in both basic and clinical research and in education in the field of transfusion medicine.

The DTM operates a CLIA approved, AABB accredited Transfusion Service (TSL) that provides immunohematology testing and blood component transfusion support.

The software module used for documentation of transfusion service testing and component modification is SoftBank while the blood administration module is Soft

ID.TX, both are software products from Soft Computer Consultants (SCC).

Objective

The objective of this Statement of Work is to provide the Transfusion Services Lab with validation services for patch installments to the currently validated Laboratory

Information System, SoftBank v25.5.3.2.9.

Scope of Work

A software patch (version 25.5.3.3.9) has been provided for SoftBank addressing issues identified post upgrade and correcting software code responsible for transmission of patient demographic information to the Soft ID.TX module. The validation services are necessary to ensure patient safety and system functionality are not impacted negatively

NIH Clinical Center

SCC Interface for CCMD Stat Laboratory

Statement of Work

- 2 -by the software changes. The vendor shall supply the necessary validation scripts and perform system function testing to include instrument interfaces and the Soft ID.TX blood administration module.

Mandatory Criteria Experience with the Soft Computer Consultants SoftBank and Soft ID.TX applications

Registered with FDA and experience with validating FDA 510K cleared devices

Quality plan in place and in writing

Management review of validation documentation to ensure quality of product and services

Change control procedure that describes how to document, track, control changes to a process, procedure or form

Perform internal audits to assess level of process control and regulatory compliance

Procedure/system(s) in place to investigate and follow-up with a corrective and preventive action plan to resolve incidents and customer complaints

Delivery options (i.e. scheduling flexibility, documentation) to meet customer needs and requirements

Required Delivery Date

The Government’s required delivery date is no later than September 1, 2017 but preferable that the delivery date be made sooner.