Spirometers, KC VA Medical Center

STATEMENT OF WORK

PORTABLE SPIROMETRY TESTING SYSTEMS

FOR PART Med Graphics® (MGC) CPFS

1. GENERAL INFORMATION

Pulmonary Function Testing (PFT) Equipment

1. The Kansas City Veterans Administration (KCVA) provides pulmonary function testing services at the KCVA Main Campus and all of the KCVA CBOC locations.  The testing is performed on an outpatient basis.  The purpose of the testing is to aid the physician in accurately determining lung function.  From the pulmonary function test results, the physician is able to diagnose the stage of lung dysfunction and prescribe the necessary intervention.  All locations will have the capability of performing basic spirometry for screenings.

1. KCVA currently has two (2) portable spirometers, brand Med Graphics® (MGC) CPFS, that must be compatible with the stationary PFT system in order to continue installation of HL7 link. The Kansas City VAMC Pulmonary Department is requesting the procurement of 10 total units to expand access at the CBOC located with in the Kansas city Area.

1.  Spirometry screening testing systems will be installed at each location, Honor, Lenexa, Shawnee, Paola, Excelsior, Belton, Cameron, Nevada, Warrensburg CBOCs.  Equipment should meet the following specifications to meet the government’s minimum requirement:

   1. 1. Capability to perform the following test modalities with accuracy and repeatable data:

         1. Forced Vital Capacity
         2. Slow Vital Capacity
         3. The transducers must provide for measurements within the following ranges:

1. 1. Each system shall be complete with the following accessory items:

      1. 1. Laptop computer with compatible interface connections to PFT system
         2. Deskjet color printer
         3. Environmental monitor (current temperature/Barometric pressure reading) interfaces into PFT computer
         4. Patient interface
         5. Regulator Kit

1. 1. System features:

      1. 1. System must have a drying sample line to remove water vapor from the sample gas
         2. Graphics and tabular presentation of data must include Global Lung Initiative predicted normal comparisons for adult and pediatric males and females
         3. System must provide ability to reduce to hard copy any display appearing on screen during testing or effort review.
         4. System must offer a set of database tools to perform database functions such as patient and staff maintenance and patient database backups.
         5. System must have capability of database query option for trending subject data and laboratory quality control.

1. 1. Operating Software

      1. Operating software compatible with MGC Breeze Platinum Elite Plethysmography
      2. The system software will provide extensive use of on-line context-sensitive help screens, step-by-step on-screen instructions, and clear documentation.
      3. Software support license compatible with MGC Breeze Platinum Elite Plethysmography
      4. Interface for test/development environments
      5. Multi-user software for test/development
      6.  Multi-user software license for PFT systems
      7. Physician review software
      8. Web review/a minimum of 5 year license with no more than 5 each
      9. Electronic signature for web review
      10. Pulmonary consult for web review
      11. HL7 interface compatible with MGC Breeze Platinum Elite Plethysmography
      12. Installation service and support
      13. Multi-user software support on all operating software
      14. System software must provide the option to allow input of user-defined predicted formulas

1. 1. Interface Specifications:

System will operate in accordance with Department of Veterans Affairs VA DIRECTIVE 6066 Washington, DC 20420 Transmittal Sheet September 2, 2014  PROTECTED HEALTH INFORMATION (PHI) AND BUSINESS ASSOCIATE AGREEMENTS MANAGEMENT

1. 1. 1. HL7 interface must be equal or compatible to Breeze Link to Breeze Connect HL7 to maintain compatibility with MGC Breeze Platinum Elite Plethysmography
      2. spirometers which includes the following:
      3. Breeze Connect HL7 Interface software
      4. HL7 ADT or Orders (ORM) connection license
      5. HLT Results (ORU) connection license.
      6. Remote installation and configuration service
      7. Up to 32 hours remote installation and configuration service
      8.  HL7 interface capabilities using TCP/IP or MLLP that can be unidirectional or bi-directional.

1. 1. Software Support Maintenance and License Agreement

Term is no less than 1 year (annual).  Term will start the earlier of (1) 60 days after interface purchase or (2) upon completion of installation.  Agreement must be renewable at end of agreement

1. Scope of Work

   1. Configure and install HL7 connection with specifications to link to VISTA network with bidirectional
   2. Backup current PFT system’s data and perform transfer of data to new system
   3. Connect laptop computers/printers to PFT system
   4. Connect weather station to interface with PFT testing program
   5. Download weather station software compatible with PFT system software
   6. Perform calibration on spirometer
   7. Install Physician review software
   8. Assure data transmission process is successful achieving the following:

1. Seamless transmission of test data to Physician Review station
2. Transmission of data from Physician Review to CPRS
   • Install Web Review with access for 5-10 seats
   • Provide Web Review Installation service/support
   • Provide 1-day on-site training for Pulmonary Physicians at KCVA Medical Center
   • Along with KCVA Bio Med technicians, the vendor will assure all patient information is securely transmitted between the server and the VISTA network
   • The C&A requirements do not apply, and a Security Accreditation Package is not required

1. Period of Performance:  Installation process will begin no more than 44 days after vendor receives purchase order.  Training process for both clinicians and Physicians will begin no more than 24 hours after installation.

1. Place of Performance:  Installation of testing equipment will be performed at the KCVA Medical Center.  Server access is only available at the KCVA Medical Center; therefore, all issues related to server access must be done at that location.   Training of personnel shall also be performed at KCVAMC.
2. Work Requirement:

Implementation

1. 1. 1. The vendor will provide a detailed plan of work including schedule for removal/ installation of new equipment and training at each CBOC (NO/BR) to allow for the clinician an opportunity to schedule patient testing at alternate time
      2. The vendor will create a backup of all files on each PFT system prior to the shutdown of the former system
      3. The vendor will assure all necessities are present for implementation of new system prior to disengaging former system
      4. Vendor will transmit all data from former system to new system once installation is complete
      5. Vendor will verify HL7 connectivity with KCVAMC Bio Med technicians, who will manage the server for the PFT system
      6. Vendor will complete a calibration on all measuring components of the PFT system: volume, diffusion, and body plethysmography.

              VA ACQUISITION REGULATION SOLICITATION PROVISION AND CONTRACT CLAUSE

The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract.

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE
 

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

1. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

1. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order. For this procurement this is not needed at this time.
2. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.
3. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.
4. Custom software development and outsourced operations must be in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.