Federal contract opportunity 36C25618Q0241 for electromedical and electrotherapeutic apparatus manufacturing at New Orleans VAMC Department of Veterans Affairs Medical Center, response was due Jan 16, 2018.

Due
Solicitation Number
36C25618Q0241
Contract Number(s)
None listed
Additional Info Link
None listed
Set-Aside
No Set-Aside Used

Amendment 36C25618Q0241 A00002



CLOSING DATE EXTENSION: January 16, 2018 12:00pm



Questions and Answers



Question - 6.2: The Pulmonary Cryosurgical System must permit maintenance professionals the ability to perform diagnostics, troubleshooting, and maintenance as required.



Our standard policy for this equipment is that the VA Medical Center Maintenance professionals will have limited abilities until they attend the manufacturers training session. Upon successful completion of training, the attendee will be provided an authorization Memo stating exactly what he/she is authorized to perform, which reflects the position of the manufacturer and the manufacturer s parent company.  As a result, can this section be removed or a line item added should the VA wish to send maintenance professionals to the manufacturers facility for this training?



Answer

à I have used the system before on the patients

àwe can set up in-service training once the equipment arrives to the facility



Question - 6.4.1: The Contractor shall provide, for the duration of the warranty period, all computer software, access keys or codes, or external devices required for the operation, calibration, or repair of the equipment purchased.   Any such items not listed on the price proposal and required for maintenance of the system, shall be taken as included with the purchase of the system. 

 



Our standard policy for this equipment is that for liability reasons the Calibration Procedures and Passwords for the VIO / APC2 devices are Not Authorized for release to Customers. Also, Maintenance / Diagnostic / Calibration software is not authorized for customer release as determined by the manufacturer s parent company.  As a result, can this requirement be removed?



Answer

à yes. 6.4.1. is removed.





Question - 6.4.2 Any minor upgrades or changes to the maintenance software, hardware, or access keys or codes shall be provided at no charge to the medical center during the time the equipment is operational at this facility. 

 

Our standard policy for this equipment is that updates as defined by the manufacturer will be completed only as being necessary and per directive from the manufacturer s parent company. Insignificant updates (i.e. Chinese language character changes) are not included in this definition.  Changes that affect functionality or device performance will be available for Ascension per guidelines as stated below.





SPECIFICALLY

 Whenever Software Updates are released, (Revision Changes) the manufacturer s parent company will:

Determine the impact per regulatory requirements.

Direct the applicability /guidelines for any required change as it applies to the manufacturers devices.   

Manufacturer by law will /must comply with the manufacturer s parent company directives.

Software revision structure and change guidelines are controlled by the manufacturer s parent company and take precedence over entities definitions/requirements for updating units.   

Manufacturer will determine related costs associated with updating devices and at their discretion determine their applicability.  

Per Manufacturer s parent company, all software updates will be provided only at the direction of manufacturer s parent company.



As a result, can this requirement please be clarified to be consistent with our standard policy?



Answer

Yes. 6.4.2. is removed.





Question - 6.5.1 The Contractor shall provide support services for a period of one year, and option of additional four years.  Support services may be in the form of telephone/teleconference and/or face-to-face when deemed necessary by the Government.   Contractor shall provide list of contact options for non-face-to-face visits.  Contractor support shall be available to the Government Monday through Friday, including weekends.





Our standard policy for this equipment is that all service is provided by our manufacturers Technical Support staff in Marietta, GA.  We, nor our manufacturer, at this time, has on-site service support. All repairs and warranty work is completed at our manufacturers DEPOT repair facility. Technical support is available 24 / 7 via a Toll-Free Number which will be provided should an Award be made to us.  As a result, can this requirement please be removed or updated to reflect our standard policy?



Answer

àyes. VA Medical Center, New Orleans agrees to the 24/7 Technical support.



Question - 6.5.5 Response time for CM repairs during normal VA working hours will be Monday through Friday, 8:00 am to 4:30 p.m.  Responses time are required at a minimum of Sixty (60) minutes call back, three (3) hours on site in an emergency and twenty-four (24) hours regular, excluding holidays.



Our standard policy for this equipment is that all service is provided by our manufacturers Technical Support staff in Marietta, GA.  We, nor our manufacturer, at this time, have on-site service support. All repairs and warranty work is completed at our manufacturers DEPOT repair facility. Technical support is available 24 / 7 via a Toll-Free Number which will be provided should an Award be made to us.  As a result, can this requirement please be removed or updated to reflect our standard policy?



Answer

àyes. VA Medical Center, New Orleans agrees to the 24/7 Technical support.



Question - 6.4.6 Preventative Maintenance (PM) inspections shall be provided at a minimum of once a year.  It shall include, but not limited to, running system diagnostics (hardware and software), calibrating, adjusting and lubricating per OEM specifications, checking for leakage current and ground wire resistance.

 



Our standard policy for this equipment is that all Service is provided by our manufacturers Technical Support staff in Marietta, GA.  We, nor our manufacturer, at this time, have on-site service support. All Preventive Maintenance requests will be the responsibility of the VA Medical Center, New Orleans to contact us or the manufacturer for such services.  As a result, can this requirement please be clarified to be consistent with what our standard policy is?



Answer

àYes. VA Medical Center, New Orleans will contact the company for services as described above.



Question - 6.5.6 The contractor is responsible for incorporating all manufacturers' recommended hardware and software updates, which ensure performance to current product specifications at no additional cost to the VA.





Our standard policy for this equipment is that per the manufacturer, all software updates will be provided only at the direction of the manufacturer s parent company.  As a result, can this requirement please be clarified to be consistent with what our standard policy is?



Answer

--àYes. VA Medical Center New Orleans agrees to the standard policy.



Question - 6.5.7 Contractor must have the capability to provide remote support via VPN access. VA will provide authorized personnel limited access for remote connectivity to the system.



We, nor the manufacturer, have the ability to provide remote support via VPN access.  As a result, can this requirement please be removed?  As a result, can this requirement be removed?



Answer

àYes. 6.5.7 is removed.



Question - 7.2 The contractor shall provide a training program to the Biomedical Engineering technicians and in-house clinical personnel.



Our standard policy for this equipment is that all technical training is provide only at the manufacturers facility in Marietta, GA, per schedule.  As a result, can this requirement please be removed?



Answer

àYes. 7.2 is removed.



Question - 7.3 Technical training must provide Biomedical Engineering with the tools and knowledge to fully operate and maintain the system.



Tools - Are the procedures and specific technical training for our manufacturers devices. It does not imply testing equipment, software or associated items that are not authorized for customer release/usage.  As a result, can this requirement please be clarified to be consistent with what our standard policy is?



Answer

Yes. VA Medical Center New Orleans agrees to this standard policy.

Amendment 36C25618Q0241 A00001

CLOSING DATE EXTENSION: January 16, 2018 12:00pm

Please send all quotes to: debra.james3@va.gov



6





This is a combined synopsis/solicitation for commercial items, prepared in accordance with the format in Federal Acquisition Regulation (FAR 12.6) as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; offers are being requested and a written solicitation will not be issued. Solicitation number 36C25618Q0241 is issued as a Request for Quote (RFQ). This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-84. Offers are due no later than Thursday, January 11, 2018 by 12:00 p.m., Central Local Time (CST), New Orleans, LA. This solicitation is set aside 100 % for Small Businesses

NOTE: All documentation submittal due times are Central local time (New Orleans, Louisiana).

SECTION A. SUPPLEMENTAL INFORMATION TO OFFERORS

SECTION B STATEMENT OF WORK/PRICE AND

COST SCHEDULE

SECTION A SUPPLEMENTAL INFORMATION TO OFFERORS

2. The Statement of Work within this solicitation is a non-negotiable document. Offers/quotes shall not include edits, revisions, additions, deletions, alterations, or track change comments to the Statement of Work.

3. NAICS code is 334510. The small business size standard is 1250.

4. Contract Type and Period of Performance:

Upon award, contract will be a Firm Fixed Price contract. The contract will consist of Contract Line Items (CLINs) for Pulmonary Cryosurgical System.

The Period of Performance is from January 17, 2018- February 9, 2018. Please read the Delivery Schedule for the delivery times and the quantities.

5. Compensation for Services Rendered:

Please include your pricing in the Price/Cost Schedule Section B.

Quotes shall include a total Firm Fixed Price for CLIN 0001- CLIN 0022 per Section B.3, Price/Cost Schedule.

6. Invoicing Procedures:

Offeror to submit invoices in arears after completion of all work and deliverables. Please see completed list of all items within the Price/Cost Schedule. See VAAR Clause 852.232-72, Electronic Submission of Payment Requests for invoicing procedures.

7. System for Award Management (Sam) Registration/Contractor Responsibility

All Contractors are required to be actively registered in the System for Award Management (SAM). (SAM Website: www.sam.gov). Registration in SAM is a requirement to do business with the Federal Government and registration in SAM shall be maintained throughout the performance of the contract.

8. Modifications:

Contracting Officers within the networking contracting office issuing the contract, only, may issue modifications to the contract.

Distribution will be made via email. No hard copies will be distributed.

9. Please note the requirements of FAR provision 52.212-3. Prospective Contractors shall complete electronic annual representations and certifications at www.sam.gov in conjunction with required registration in the SAM database. Representations & Certifications must be completed and/or updated by the date and time offers are due.

10. Working hours are between 08:00 am 04:30 pm, Monday through Friday. All federal holidays excluded. Any work outside of normal working hours must be pre-approved by the CO and COR. Federal holidays are available at the Federal Holiday OPM Site.

11. Proposal Total Firm Fixed Price:

12. Solicitation Questions

The specific requirements for this solicitation are outlined in the Statement of Work. Questions concerning this solicitation shall be submitted in writing only. (Questions will not be answered or addressed telephonically). Questions shall be submitted via electronic mail (e-mail) to: debra.james3@va.gov . Questions will be accepted up to 4:00 p.m. (CST), January 9, 2018. All questions are to be written and sent via email debra.james3@va.gov and answers will be published via amendment FedBizOpps to the solicitation.

13. Amendments to Solicitation

Amendments to this solicitation shall be posted on FedBizOpps only (Website (www.fbo.gov). It is the responsibility of the contractor to monitor any updates via www.fbo.gov for any amendments to this solicitation. All questions and answers will be published via an amendment.



SECTION B Statement of Work

Southeast Louisiana Veterans Health Care System

Annual Fire Extinguisher Inspection

New Orleans, LA

Pulmonary Cryosurgical System

Southeast Louisiana Veterans Health Care System (SLVHCS), New Orleans, LA

11/21/2017

1. PURPOSE

1.1. The purpose is to deliver and install a pulmonary cryosurgical system at SLVHCS.

2. SCOPE

2.1. The Contractor shall provide, transport and install all listed equipment. All products must meet all salient characteristics defined in this section.

2.2. All equipment and installation must meet manufacturers and VA specifications.

2.3. The Contractor shall furnish all supplies, equipment, facilities and services required for delivery and installation of the supplies and equipment.

2.4. The Contractor is responsible for any missing parts and components not included in order to carry out the installation.

2.5. SALIENT CHARACTERISTICS

2.5.1. Pulmonary Cryosurgical System equivalent to ERBE Cryosurgical System, as listed below (for training, functionality, and interoperability, Pulmonary Cryosurgical System should match ERBE Cardio Cryosurgical System in installed/operational at SLVHCS):

Flexible Hose

Pin Index Connector

Footswitch

Sterilization Container

Flexible Probe, 2.4 mm x 900 mm

Flexible Probe, 1.9 mm x 900 mm

Connector Adaptor

Argon Plasma Coagulator (APC)

Pressure Reducer with Sensor

Cart with Footswitch Holder

Wire Basket

APC Fastening Set

Cart Fastening Set

Ignition Tester

Electrosurgical (ESG) Unit

Two Pedal Footswitch with Bracket

Connecting Cable

Argon Gas Tank (Full)

2.5.2. APC Extended Warranty available

2.5.3. ESG Unit Extended Warranty available

2.5.4. Installation (must be included)

2.5.5. Training (must be included)

2.6 DELIVERY AND INSTALLATION

2.6.1 DELIVERY

2.6.1.1 Contractor shall deliver all equipment to the SLVHCS Central Energy Plant building 2400 Canal St, New Orleans, LA 70119, no later than (NLT) January 29, 2018.

2.6.2 INSTALLATION

2.6.2.1 All equipment shall be floor mounted by contractor upon delivery unless otherwise noted above.

2.6.2.2 Install all equipment to manufacturer s specifications maintaining Federal, and Local safety standards

2.6.2.3 Installation must be completed NLT February 9, 2017. All work shall be completed between 8:00 a.m. and 4:30 p.m. Monday Friday. All federal holidays, excluded. Federal holidays are available at the Federal Holiday OPM Site.

2.6.2.4 If there is an operational conflict with installation, night or weekend installation may be required. Government will provide a 72 hours' notice of change of installation hours.

2.6.2.5 The contractor shall coordinate all deliveries, staging areas, installations, and parking arrangements with the COR.

2.6.2.6 The Contractor shall remove all related shipping debris and cleanup any construction associated with delivery and installation of the specified items. Contractor shall remove all packaging from the SLVHCS premises. The Contractor shall be responsible for any damage to the building that occurs due to Contractor error or neglect.

2.7 SITE CONDITIONS: There shall be no smoking, eating, or drinking inside the hospital at any time.

3. INSPECTION AND ACCEPTANCE:

3.1 The Contractor shall conduct a joint inspection with the COR upon delivery of equipment.

3.2 Contractor shall provide dates of completion of punch list items and replacement parts and/or short ship items from the manufacturer(s).

3.3 The COR shall ensure all work is completed satisfactorily prior to acceptance. Disputes shall be resolved by the Contracting Officer.

4. DELIVERY/STORAGE REQUIREMENTS

4.1 Deliver materials to job in manufacturer's original sealed containers with brand name marked thereon.

4.2 Package to prevent damage or deterioration during shipment, handling, storage and installation. Maintain protective covering in place and in good repair until removal is necessary.

4.3 Deliver specified items only when the site is ready for installation work to proceed.

4.4 Store products in dry condition inside enclosed facilities.

4.5 Delivery and Installation will be coordinated through the COR.

5. DELIVERABLES

5.1 Operation and Maintenance Manuals

5.1.1 Binders and/or digital copies, as required

5.1.2 Deliver compilation of all manufacturer recommended maintenance schedule and operation materials packaged in binder(s) to COR upon completion of installation.

6. MAINTENANCE AND SUPPORT SERVICES REQUIREMENTS

6.1 The vendor must provide preventive maintenance services, or preventive maintenance training to Users and Biomedical Technicians when appropriate, to meet at minimum The Joint Commission standards.

6.2 The Pulmonary Cryosurgical System must permit maintenance professionals the ability to perform diagnostics, troubleshooting, and maintenance as required.

6.3 Technical training must provide Biomedical Engineering with the tools and knowledge to fully operate and maintain the system.

6.4 Licensing Software updates

6.4.1 The Contractor shall provide, for the duration of the warranty period, all computer software, access keys or codes, or external devices required for the operation, calibration, or repair of the equipment purchased. Any such items not listed on the price proposal and required for maintenance of the system, shall be taken as included with the purchase of the system.

6.4.2 Any minor upgrades or changes to the maintenance software, hardware, or access keys or codes shall be provided at no charge to the medical center during the time the equipment is operational at this facility.

6.4.3 All application software licenses are included in the purchase of the equipment and shall not require a renewal charge for the period of time the equipment is in use in the facility.

6.5 Support Services

6.5.1 The Contractor shall provide support services for a period of one year, and option of additional four years. Support services may be in the form of telephone/teleconference and/or face-to-face when deemed necessary by the Government. Contractor shall provide list of contact options for non-face-to-face visits. Contractor support shall be available to the Government Monday through Friday, including weekends.

6.5.2 Contractor shall furnish all management, equipment inclusive of parts, material, travel and labor required to support and maintain in good working condition.

6.5.3 All materials and services provided shall be according to the OEM specifications and guidelines. Contractor shall repair any inadequate or improper repairs performed at a time convenient to the VA at no additional expense to the VA.

6.5.4 The contractor will furnish all parts including glassware, worn parts and accessories required in the corrective maintenance (CM) and preventive maintenance (PM) of the system,

6.5.5 Response time for CM repairs during normal VA working hours will be Monday through Friday, 8:00 am to 4:30 p.m. Responses time are required at a minimum of Sixty (60) minutes call back, three (3) hours on site in an emergency and twenty-four (24) hours regular, excluding holidays.

6.4.6 Preventative Maintenance (PM) inspections shall be provided at a minimum of once a year. It shall include, but not limited to, running system diagnostics (hardware and software), calibrating, adjusting and lubricating per OEM specifications, checking for leakage current and ground wire resistance.

6.5.6 The contractor is responsible for incorporating all manufacturers' recommended hardware and software updates, which ensure performance to current product specifications at no additional cost to the VA.

6.5.7 Contractor must have the capability to provide remote support via VPN access. VA will provide authorized personnel limited access for remote connectivity to the system.

6.5.8 At the completion of each PM inspection or repair service call, the contractor shall provide a written service report to the Contracting Officer's Representative, or his/her designee. This report will clearly indicate details of service provided including the date of service, the model and serial number of equipment serviced, and a description of the service performed.

7. TRAINING:

7.1 Contractor shall provide On-site training of the equipment to the Clinical Users. Scheduling of operator training shall be coordinated with the SLVHCS COR after installation is complete

7.2 The contractor shall provide a training program to the Biomedical Engineering technicians and in-house clinical personnel.

7.3 Technical training must provide Biomedical Engineering with the tools and knowledge to fully operate and maintain the system.



8. PROTECTION OF PROPERTY

8.1 Contractor shall protect all items from damage. The Contractor shall take precaution against damage to the building(s), grounds and furnishings. The Contractor shall repair or replace any items related to building(s) or grounds damaged accidentally or on purpose due to actions by the Contractor.

8.2 The Contractor shall perform an inspection of the building(s) and grounds with the COR prior to commencing work. To insure that the Contractor shall be able to repair or replace any items, components, building(s) or grounds damaged due to negligence and/or actions taken by the Contractor. The source of all repairs beyond simple surface cleaning is the facility construction contractor (or appropriate subcontractor), so that building warranty is maintained. Concurrence from the VA Facilities Management POC and COR is required before the Contractor may perform any significant repair work. In all cases, repairs shall utilize materials of the same quality, size, texture, grade, and color to match adjacent existing work.

8.3 The Contractor shall be responsible for security of the areas in which the work is being performed prior to completion.

8.4 Contractor shall provide floor protection while working in all VA facilities. All material handling equipment shall have rubber wheels.

9. WARRANTY

9.1 The contractor shall provide a one year manufacturer s warranty on all parts and labor.

9.2 The warranty shall include all travel and shipping costs associated with any warranty repair.

10. SECURITY REQUIREMENTS















B. PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM NUMBER

DESCRIPTION OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

0001

PULMONARY CRYO SYSTEM



1.00

EA

__________________

__________________

0002

FLEXIBLE HOSE



1.00

EA

__________________

__________________

0003

PIN INDEX CONNECTOR



1.00

EA

__________________

__________________

0004

FOOTSWITCH



1.00

EA

__________________

__________________

0005

STERILIZATION CONTAINER



4.00

EA

__________________

__________________

0006

FLEXIBLE PROBE, 2.4 MM X 900 MM



2.00

EA

__________________

__________________

0007

FLEXIBLE PROBE, 1.9 MM X 900 MM



2.00

EA

__________________

__________________

0008

CONNECTOR ADAPTOR



1.00

EA

__________________

__________________

0009

ARGON PLASMA COAGULATOR



1.00

EA

__________________

__________________

0010

PRESSURE REDUCER WITH SENSOR



1.00

EA

__________________

__________________

0011

CART WITH FOOTSWITCH HOLDER



1.00

EA

__________________

__________________

0012

WIRE BASKET



1.00

EA

__________________

__________________

0013

APC FASTENING SET



1.00

EA

__________________

__________________

0014

CART FASTENING SET



1.00

EA

__________________

__________________

0015

IGNITION TESTER



1.00

EA

__________________

__________________

0016

ELECTROSURGICAL UNIT



1.00

EA

__________________

__________________

0017

SYSTEM UPGRADE



1.00

EA

__________________

__________________

0018

TWO PEDAL FOOTSWITCH WITH BRACKET



1.00

EA

__________________

__________________

0019

CONNECTING CABLE



1.00

EA

__________________

__________________

0020

ARGON GAS TANK (FULL)



1.00

EA

__________________

__________________

0021

ELECTROSURGICAL UNIT EXTENDED WARRANTY



1.00

EA

__________________

__________________

0022

APC EXTENDED WARRANTY



1.00

EA

__________________

__________________









GRAND TOTAL

__________________

Place of Performance