36C24419Q0778-006.docx

FedBizOpps Amendment to a Previous Combined Solicitation

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* = Required Field FedBizOpps Amendment to a Previous Combined Solicitation Rev. March 2010 (C2) MicroLoop Spirometer System

CORRECTED COPY TO STATEMENT OF WORK

19805 36C24419Q0778 07-12-2019 N 339112 Department of Veterans Affairs Network Contracting Office 4 debra.willard@va.gov PVAMC Philadelphia VA Medical Center 3900 Woodlawn Ave Philadelphia, PA 19139

PLEASE SEE CORRECTED COPY OF STATEMENT OF WORK:

CPL Michael J Crescenz VA Medical Center

STATEMENT OF WORK

Requestor/Program Manager Name: Dr. Frank Austan Title: Director of Respiratory Care Services Section: Medicine Service Address: CMCVAMC Medical Center 3900 Woodland Avenue, Philadelphia, PA 19139 Phone Number: (215) 823‐5800 ex 6281 E‐Mail Address: Frank.Austan@va.gov

VMAX ENCORE VS 22 PULMONARY FUNCTION MESAUREMENT SYSTEM

The Philadelphia’s CMCVA Medical Center is seeking to upgrade its currently used Pulmonary Function Test (PFT) systems purchased 10 years ago. PFT technology the last 10 years has exponentially evolved into improving accuracy and precision.

The following the working characteristics are expected of a PFT System and are met by the proposed Vmax Encore VS 22 Pulmonary Function Measurement System.

1. Provide stated specification limits for performance (accuracy and precision) for every lung function measurement (Indication for Use) including spirometry (FVC), DLCO, and lung volumes (FRC, plethysmography) as required by the FDA and ISO.

2. Provides end‐users the tools to irrefutably validate the output performance for each of these measurements to the stated specification as required by the FDA and ISO (International Organization for Standardization) prior to patient testing.

3. Be able to provide the end‐user consistent delivery of valid results for all PFT systems’ clinical indications

4. PFT Unit must be capable of measuring the following:

Spirometry/Pulmonary Function Test Procedures: Calibration Pre‐and Post‐Medication Testing Bronchodilator Overlays Flow Volume Loops (Forced Vital Capacity) Lung Subdivisions (Slow Vital Capacity) Maximum Voluntary Ventilation Lung Volumes Determination (N2 Method) Gas Distribution Closing Volume Diffusing Capacity‐Single Breath Diffusing Capacity‐Intra‐Breath. Software Vision Software Programs Include Extensive Help Menus and Computer Instruction Tutorial Presentation in a User‐Friendly Microsoft™ Windows Menu Environment Data Base Management with EZ View and Bar‐Trac Graphic Presentations, Quality Assurance Monitoring An additional factor of consideration in purchasing Vmax Encore VS 22 Pulmonary Function System.

Philadelphia VA pulmonologists and technologists are learned in the operational use of this highly specialized equipment.

RECOMMENDATION

We recommend the purchase of the Vmax Encore 22 Pulmonary Function Testing Equipment, from Care Fusion Respiratory Technologies. POC Gerard Mulholland 714‐922‐7456 Program Need Date May 27th 2019 Location Suites A430 and A431 (4th FL, BLD 1) CMCVA Medical Center 3900 Woodland Avenue 19139 Philadelphia, PA 19139 End of Document