SPECIAL NOTICE
65 -- Periflux 6000 tcp02 Vascular
- Notice Date
- 9/16/2021 8:06:56 AM
- Notice Type
- Special Notice
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- 241-NETWORK CONTRACT OFFICE 01 (36C241) TOGUS ME 04330 USA
- ZIP Code
- 04330
- Solicitation Number
- 36C24121Q0870
- Archive Date
- 11/15/2021
- Point of Contact
- Issa Shawki, Contracting Officer, Phone: 774-826-3192
- E-Mail Address
-
issa.shawki@va.gov
(issa.shawki@va.gov)
- Awardee
- null
- Description
- The Department of Veterans Affairs, Networking Contracting Office (NCO 01) located in Brockton, MA intends to enter into a sole source procurement, pursuant to the authority of FAR 6.302-1, with Perimed Inc., for the following requirement: STATEMENT OF WORK SCOPE OF WORK: The Contractor shall provide all labor, personnel, equipment, tools, materials, supervision and other items and services necessary to perform the following: Installation and implementation of a fully functional Periflux 6000 tcp02 Vascular Clinical Training for Providence VA Medical Center staff. Technical Training for Providence VA Medical Center staff. 1. EQUIPMENT The following equipment shall be provided and installed by the Contractor in the space determined by the Government. All equipment installed by the Contractor shall be FDA approved for use, in new condition, and fully operational in accordance with manufacturer literature specifications. A minimum of two (2) copies of any associated operational and/or service manuals shall be provided for all equipment listed below as applicable. flux 6000 tcp02 Vascular Periflux 6000 tcp02 Vascular System; The PeriFlux 6000 System offers the unique capability to simultaneously assess both Toe Pressure and PVR as well as measure Transcutaneous Oxygen in the tissue with one system saving limbs, lives, and decreasing costs. Reports instantly generated with all clinical information clearly stated. The Contractor shall provide all tools and equipment necessary to properly and safely perform the services set forth within this statement of work. This shall include, but is not limited, to all Personal Protective Equipment (PPE) which may be required for the work to be completed in a safe manner. The Contractor shall provide any equipment necessary for proper infection control measures during installation. 2. SALIENT CHARACTERISTICS The Contractor shall provide a fully functional system that meets the following characteristics: Salient Characteristics Periflux 6000 tcp02 Vascular The PeriFlux 6000 Combined System can simultaneously assess pressure at up to 6 sites (arms, fingers and legs). The PeriFlux 6000 Combined System has a built-in air compressor, there is no need for instrumental air from an outlet in the wall. It is equipped with thermostatic Laser Doppler probes, locally heating the toes to 40 degrees C (104 degrees F), as cold ischemic feet need heating prior to the measurement. This makes traditional ways of heating, like a warm foot bath, heating cushions and such obsolete. The Laser Doppler sensors do not require pulsatility like Photoplethysmography (PPG) sensors do. This is of specific importance, meaning that a measurement result can be obtained even on patients with calcified vessels and/or constrained blood flow, as Laser Doppler can assess very low pressures on patients with CLTI. The PeriFlux 6000 Combined System uses a thermostatic Laser Doppler technique which in effect standardizes the measurements and makes results comparable, reliable and reproducible. The system is also equipped for measurement of Transcutaneous Oxygen (tcpO2) in the tissue to reflect the metabolic state of the limb. This microcirculatory assessment is particularly useful for wound healing prediction, amputation level determination and qualification for Hyperbaric Oxygen Therapy. 2. AREAS TO BE SERVICED (one or all as necessary and appropriate to this contract) Department of Veterans Affairs Providence VA Medical Center Vascular Department 830 Chalkstone Ave Providence, RI 02908 3. INSTALLATION The Contractor shall provide all labor, materials, tools, equipment and etc. to prepare for and complete the installation of the equipment in the space determined by the Government. Project implementation meetings, if necessary, shall be coordinated with the COR. Installation and implementation dates are to be coordinated in advance with the Contractor and the COR. All employees of the Contractor and subcontractors shall comply with VA security management program and obtain the permission of the VA police, be identified by project and employer, and restricted from unauthorized access. All installation personnel shall be trained by the manufacturer on how to properly install the equipment. Resumes and certifications shall be submitted for review upon request by the Government. All installation personnel shall be trained by the manufacturer on safe and proper Personal Protective Equipment (PPE) usage and general infection control regulations and requirements relevant to the work outlined in the Scope of Work. he Contractor shall communicate to the Government the estimated downtime required to Tcomplete full installation and testing of Periflux 6000 tcp02 Vascular system. If the Contractor is unable to install the equipment to its normal operational state within 24 hours the Contractor shall compensate the Government for the downtime by extending the warranty service in a period equivalent to the downtime of the equipment. The Contractor shall be responsible for the safe removal and disposal of all trade-in equipment as applicable. The Contractor shall be responsible for the safe removal and disposal of all packing materials and related waste generated during installation. 4. TRAINING The Contractor shall provide a comprehensive onsite training program for the operating clinicians. This training program shall include at the minimum the following sessions: (i) Technical Training, (ii) Operational Training, (iii) Administrative Training, and (iv) Hardware and Software Trouble-shooting. Training shall occur onsite during normal business hours, 7:00am-3:30pm, Monday through Friday. Competency assessments shall be provided with the training. Onsite training is to be scheduled in advance with the Providence VA Medical Center through the COR. The Contractor shall provide onsite general overview technical training for Clinical Engineering personnel as requested. Training shall include a technical overview of the mechanics, electronics, and general operations of the system. Training shall cover detailed instruction regarding the preventative maintenance, troubleshooting, and general maintenance of the equipment. 5. INSPECTION AND ACCEPTANCE The Contractor shall conduct a joint inspection with the COR upon delivery of equipment. Contractor shall provide dates of completion of punch list items and replacement parts and/or short ship items from the manufacturer(s). The COR shall ensure all work is completed satisfactorily prior to acceptance. Disputes shall be resolved by the Contracting Officer. 6. WARRANTY The contractor shall provide a one year manufacturer s warranty on all parts and labor. The warranty shall include all travel and shipping costs associated with any warranty repair. 7. TASK FREQUENCY AND INSTRUCTIONS The work set forth in the Scope of Work shall be completed in a single visit, be it a single day or multiple days as required for appropriate completion. All work is to be scheduled in advance with the COR. Equipment delivery shall not preceed installation by more than 20 days. Installation and implementation must be immediately followed by clinical user training including go live support. Implementation and integration with VistA CPRS shall not exceed 90 days from date of award. 8. SPECIAL WORK REQUIREMENTS The Contractor shall comply with any and all Infection Control Risk Assessment requirements deemed appropriate by the Providence VA Medical Center during all portions of the work set forth in the Scope of Work. The Contractor must comply with security, privacy, and safety issues in accordance to VA standards, policies, and directives set forth at all times while providing the work outlined in the Scope of Work. 9. PROPERTY DAMAGE The contractor shall take all necessary precautions to prevent damage to any government property. The contractor shall report any damages immediately and shall be assessed current replacement costs for property damaged by the contractor, unless corrective action is taken. Any damaged material (e.g. trees, shrubs, lawn/turf, cubs, gutters, sidewalks, etc.) will be replaced in a timely manner or corrected by the contractor with like materials, at no extra cost to the government, upon approval of the Contracting Officer. 10. ATTACHMENTS None. 11. IDENTIFICATION, PARKING, SMOKING, CELLULAR PHONE USE AND VA REGULATIONS The contractor's employees shall wear visible identification at all times while on the premises of the VA property. It is the responsibility of the contractor to park in the appropriate desig nated park ing areas. Information on parking is available from the VA Police-Security Service. The VA will not invalidate or make reimbursement for parking viola tions of the con tractor under any con ditions. Smoking is prohibited inside any buildings at the VA. Cellular phones and two way radios are not to be used within six feet of any medical equipment. Posses sion of weapons is prohibited. Enclosed containers, including tool kits, shall be sub ject to search. Violations of VA regulations may result in a citation answer able in the United States (Federal) Dis trict Court, not a local district state, or municipal court. 12. COMPLIANCE WITH OSHA BLOODBORNE PATHOGENS STANDARD The contractor shall comply with the Federal OSHA Blood borne Pathogens Standard. The contractor shall: A. Have methods by which all employees are educated as to risks associated with blood borne pathogens. B. Have policies and procedures which reduce the risk of employee exposure to blood borne pathogens. C. Have mechanisms for employee counseling and treatment following exposure to blood borne pathogens. D. Provide appropriate personal protective equipment/clothing such as gloves, gowns, masks, protective eyewear, and mouthpieces for the employee during performance of the contract. The NAICS code for this requirement is 339112. Perimed Inc. is the only contractor capable of satisfying the statement of work because they are the sole provider of the PeriFlux 6000 and associated equipment in the USA. The PeriFlux is required because it is the only tcpO2 device on the market that can measure oxygen released from the capillaries through the skin. The PeriFlux is also the only FDA 510(k) approved SPP-capable device for sale in the USA. This notice of intent is not a solicitation nor is it a request for proposal. However, interested parties that believe they can satisfy the requirement listed above must clearly identify their capability to do so in writing by Friday, September 17, 2021 at 5 pm EST time. Responses should be sent to Issa Shawki at issa.shawki@va.gov. Information submitted in response to this notice will be used solely to determine whether competitive procedures could be used for this acquisition. A determination not to open the requirement to competition based upon responses to this notice is solely within the discretion of the Government.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/d6d02eb2162540de999da3d478e20853/view)
- Record
- SN06135174-F 20210918/210916230117 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's SAM Daily Index Page |