Sole_Source_Olympus_190_Series.docx

Drager V500 Ventilator Sole Source Justification

Part I. Background Information and Description of Acquisition:

1. Program Office: Critical Care Medicine Department

NIH/CC/CCMD

Bernard Garcia 10/2C145 301-827-9191

2. Project- Replacement of Olympus Bronchoscopy, Series 160 System to the Series 190 System.

3. Purpose/Brief History

a. The Clinical Center is a clinical research hospital providing medical services for patients participating in human research protocols of the National Institutes of Health (NIH). The Clinical Center (CC) provides patient care facilities and services for clinical investigations by the NIH Institutes, research in related areas, and other training programs.

The Department of Critical Care Medicine provides treatment and therapy to critically ill inpatients and performs research studies on critical care diseases. Bronchoscopy is performed, if indicated, for clinical diagnosis of lung involvement to enable proper treatments and to promote a positive patient outcome. Bronchoscopy is also performed for protocol driven patient data.

The Critical Care Therapy Section is responsible for maintaining the bronchoscopy system, assisting the physician with the procedure, and supporting the patients during the bronchoscopy. Respiratory therapy personnel manage all aspects of bronchoscopy system and equipment to ensure patient safety and availability of equipment.

b. The purpose of request is to provide sole source justification for the purchase and replacement of our no longer supported Olympus Bronchoscopy, Series 160 System with the Series 190 System. The Series 160 bronchoscopes will no longer be supported or repaired by Olympus after July 1, 2017. The Olympus Bronchoscopy, Series 190 System provides enhanced bronchoscope movements and viewing that are necessary for the management of the critically ill patient. The Series 190 System is a replacement of equipment only and will still interface with current system application and electronic medical record.

c. The National Institutes of Health, Critical Care Medicine Department, has a requirement to provide state-of-the-art supportive critical care to the critically ill patient using this enhanced bronchoscopy system.

Part II. Facts and Reasons to Justify Other Than Full and Open Competition

1. Usage in the Clinical Center: The Olympus Bronchoscope System has been used in the Clinical Center since 1999. The bronchoscope system has a proven history of dependability and have been exceptionally maintained by Olympus support. Respiratory Therapy and physician staff are familiar with the Olympus system and therefore additional training on a system by a new manufacturer is not necessary.

2. Interface with CRIS and Provation Application: The Olympus Bronchoscope System has already been tested and is currently using the Provation Application that is used within the Clinical Center, i.e. GI and Operating Room. The Provation Application currently interfaces with CRIS, the electronic medical record of the Clinical Center.

Sole Source Impact: If any other bronchoscopy system were considered the impact would be great and patient safety could be compromised:

· The IT staff would need to evaluate a new bronchoscopy system manufacturer for compatibility with the current application and interface.

· If a bronchoscopy system from a different manufacturer was purchased, the IT staff would have to build and test the new bronchoscopy system in order to have the system interface with the electronic medical record.

· Possible incompatibility with the current system application requiring the purchase of a new system application and interface.

· Inconsistency of applications within the Clinical Center could pose a patient safety issue.