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Defibrillator replacement


Pennsylvania, United States
Government : Federal
RFQ
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Combined Synopsis/Solicitation
(i) This is a combined synopsis/solicitation for replacement of 102 each Defibrillators, Brand Name or Equal as prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. A firm-fixed price purchase order is anticipated.

The Department of Veteran Affairs, Pittsburgh VA Medical Center requires the acquisition, delivery, and installation of all items listed below. Delivery/Installation will begin within 30 days ARO with a Period Of Performance for completion of 180 days. Deliver to the following location: VAPHS, University Drive C, Pittsburgh, PA 15240 Attn; BIOMED, Austin Hampton. Minimum requirements will be outlined in the specifications under Sections (v) and (vi).

Contractors shall have no access to Department of Veterans Affairs computer systems.B B If required, each contractor employee working on-site must complete training course VA Privacy and Information Security Awareness and Rules of Behavior .B B When a new contractor employee arrives on-site they must contact Contracting Officer Representative (COR), who will arrange for this training.
(ii) The solicitation number is 36C24419Q1054 and is issued as a request for quotation (RFQ).
(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-101 effective Oct 26, 2018.
(iv) This solicitation is set aside 100% for Service-Disabled Veteran-Owned Small Businesses and the associated NAICS code 339113 has a small business size standard of 1000.
(v) Contract Line Items (CLIN) and Statement of Need Listed below:
PRICE/COST SCHEDULE
ITEM NUMBER
DESCRIPTION OF SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT

0001


12.00

EA

__________________

__________________



Bundle: FIPS140-2 compliant device, w/ ACPA (Trending, SpO2, SpCO, NIBP, 12-Lead ECG, EtCO2, BT, Temp) Monitor/Defib, Adaptive Biphasic, Manual & AED, Color LCD, 100mm Printer, Noninvasive Pacing, Metronome, Trending, SpO2, NIBP, 12-Lead ECG, EtCO2, Carbon Monoxide, Bluetooth, Temp. INCLUDED: 2 PAIR QUIK-COMBO ELECTRODES PER UNIT, TEST LOAD, N-SERVICE DVD (one per order) , SERVICE MANUAL CD (one per order), ShipKit (RC Cable), AC POWER ADAPTER, EXTENSION CABLE (5ft 3in), and AC POWER CORD. HARD PADDLES, BATTERIES, NO CARRYING CASE. EIL 13AED, CSN: 6515-438660, NXR-NX PLAN-BIOMED-AED





0002

Bundle: FIPS140-2 compliant device (Pacing and Masimo SpO2) w/ CodeManagement Module (Wireless & EtCO2) EIL 13AED, CSN: 6515-438660, NXR-NX PLAN-BIOMED-AED

90.00

EA

__________________











GRAND TOTAL

__________________


(vi) SALIENT CHARACTERISTICS, STATEMENT OF NEED:

Defibrillators are lifesaving equipment designed to restore a normal heart rhythm by sending an electrical impulse, or shock, to the heart. They are used during medical emergencies and routine electrophysiology procedures to correct arrhythmias and restore a normal heart rhythm if the heart suddenly stops. Currently, the defibrillator fleet at the VAPHS contains units that either have surpassed or approaching the life expectancy threshold. Analyzing the work order history, i.e. frequency of work orders and cost associated with repairs, indicate the need for replacement, and because these units are vital for life support standardizing the units will help promote a safe environment for staff and patients. Biomedical Engineering, in conjunction with the Cardiopulmonary Resuscitation (CPR) Committee, is looking to replace the current units with a defibrillation device that will allow for compliance with the American Heart Association (AHA) Guidelines for Cardiopulmonary Resuscitation (CPR) and Emergency Cardiovascular Care (ECC). B VAPHS currently adheres to resuscitation recommendations from the AHA Get With the Guidelines program, maintaining a standard of first defibrillation less than 2 minutes from the onset of cardiac arrest. In order to summarize the importance and timeliness of this lifesaving procedure, the purpose of defibrillation is to apply a controlled electrical shock to the heart, leading to depolarization of the entire electrical conduction system of the heart. However, if not enough energy (Joules) is used for defibrillation the heart may not completely depolarize, in which case the lethal rhythm will not be terminated and an increased amount of energy may be required during a subsequent shock. Purchase of new defibrillation devices will allow clinical staff to continue to provide patients with quality care during medical emergencies and improve patient outcomes.

Defibrillators have a high ambulation rate inside the hospital, which presents potential issues locating and accessing the units when service is required. VAPHS is seeking the means to monitor the status of functionality for each defibrillator in the fleet. This includes but not limited to daily test pass or fail status. This will provide ample notification to Biomedical Engineering (Biomed) when a unit needs service. The awarded vendor shall provide this capability to VAPHS via a FIPS 140-2 compliant wireless connection and be expected to present the FIPS certificate at the time of award. Additionally, the awarded vendor must have ability to send code summary information to centralized server from unit after code completion via the secured, private VA wireless infrastructure.

The period of performance (POP) will be six-months (180 days) from notice to proceed (NTP). There are 102 units that will be replaced by the end of this acquisition. Additionally, four trainers will be provided. With this purchase, it is the government s expectation the contractor will provide initial and follow-up training to both clinical and technical personnel. Additionally, the contractor will provide a 3-year warranty for each unit. This warranty will cover all parts and labor required to repair a malfunctioning unit.


DEFINITIONS/ACRONYMS:

A. Engineer(ing) - Supervisor or designee.

B. CO - Contracting Officer

C. COR - Contracting Officer s Representative

D. PM - Preventive Maintenance Inspection. Services which are periodic in nature and are required to maintain the equipment in such condition that it may be operated in accordance with its intended design and functional capacity with minimal incidence of malfunction or inoperative conditions.

E. FSE - Field Service Engineer. A person authorized by the contractor to perform maintenance (corrective and/or preventive) services on the VAMC premises.

F. ESR - Vendor Engineering Service Report. A documentation of the services rendered for each incidence of work performance under the terms and conditions of the contract.

G. Acceptance Signature - VA employee who is authorized to sign-off on the ESR which indicates that the PM has been concluded or is still pending completion, or that the Emergency Repair has been accomplished or is still in a pending status.

H. Authorization Signature - COR's signature; indicates COR accepts work status as stated in ESR.

I. NFPA - National Fire Protection Association.

J. CDRH - Center for Devices and Radiological Health.

K. VAMC - Department of Veterans Affairs Medical Center

L. VHA - Department of Veterans Affairs Hospital



EQUIPMENT REQUIREMENTS:

DEFIBRILLATOR:

FDA 510(k) approval
Bi-phasic defibrillation
Have current Federal Information Processing Standards (FIPS) compliance document, must provide certificate number
Ability to have step sequence for shocks, delivering at least 200 Joules (J) as needed
Ability to toggle between manual and automatic external defibrillator (AED) modes
Provides audible alerts for users, such as Stand clear , Analyzing
Ease of use during medical emergencies
Must not weigh more 15 pounds
Pacing capabilities should include fixed and demand
Demand pacing mode should be able to recognize heart function
Pacing rate should range from 40 to 170 pulses per minute
Parameters to display and monitor:
End tidal carbon dioxide (EtCO2)
Pulse oximetry
Non-invasive blood pressure
Invasive blood pressure
Temperature
Output current for pacemaker must range between 0 and 200 milliamps
Printer for code summary should have the ability include but not limited to:
ECG waveform
Annotated events, like medication administration or defibrillation
Time and date
Lead configuration must include:
I
II
III
aVR
aVF
aVL
Paddles must have the ability to automatically convert to pediatric
Capable of defibrillation completion in less than 2 minutes, including pediatric defibrillation
Has internal feedback loop to alert staff, either visually or audibly, of compression quality to include but not limited to depth, rate and chest recoil
Ability to attach vendor-provided strap for ease of transport
If possible, have ability to attach a vinyl pouch for items need during utilization, like medication
Accessories to be included in purchase:
Pads, prefer disposable
Paddles
Adaptors
Non-invasive blood pressure cuff
Ability to use Philips bedside monitors accessories, like ECG leads, blood pressure cuff, pulse oximetry and invasive cable monitoring
Ability to anchor machine to other devices, like beds, stretchers or wheelchairs
Maintenance database
Ability to filter signal noise to display underlying rhythm of patient
Ability to automatically change time on unit by connecting to centralized server
Have single connection point for pads
SERVER:
Must be compatible with Windows 2012 or newer
Ability to be virtualized if VAPHS chooses to virtualize server
Must have at least 16 gigabytes (GB) of RAM
Must provide anti-virus and malware software
Contractor will provide a turn-in credit for current VAPHS defibrillators, which are listed below in Tables 1 and 2.

Table 1: Summary if VAPHS defibrillator inventory

Manufacturer

Model
Quantity
Life Expectancy
PHYSIO CONTROL

LIFEPAK 20E
84
8 YEARS
PHYSIO CONTROL

LIFEPAK 15
17
8 YEARS
PHYSIO CONTROL

LIFEPAK 20
1
8 YEARS

Table 2: Inventory listing of defibrillators

EE#

Manufacturer
Model
Serial#
Location
337863

PHYSIO CONTROL
LIFEPAK 20E
38736496
3A126-1-UD
337864

PHYSIO CONTROL
LIFEPAK 20E
38736455
3A145.1-1-UD
337865

PHYSIO CONTROL
LIFEPAK 20E
38736513
1NW130-1-UD
337866

PHYSIO CONTROL
LIFEPAK 20E
38736509
1A243-1-UD
337867

PHYSIO CONTROL
LIFEPAK 20E
38736464
3E115-1-UD
337868

PHYSIO CONTROL
LIFEPAK 20E
38736435
10W138-1-UD
337869

PHYSIO CONTROL
LIFEPAK 20E
38736473
3A191-1-UD
337870

PHYSIO CONTROL
LIFEPAK 20E
38736510
AE148-1-UD
337871

PHYSIO CONTROL
LIFEPAK 20E
38736501
3M127B-29-UD
337872

PHYSIO CONTROL
LIFEPAK 20E
38736475
3N239-1-UD
337873

PHYSIO CONTROL
LIFEPAK 20E
38736466
4N115-1-UD
337874

PHYSIO CONTROL
LIFEPAK 20E
38736484
4M127B-29-UD
337875

PHYSIO CONTROL
LIFEPAK 20E
38736512
AN125-1-UD
337876

PHYSIO CONTROL
LIFEPAK 20E
38733141
5A109-1-UD
337877

PHYSIO CONTROL
LIFEPAK 20E
38736462
6W137-1-UD
337878

PHYSIO CONTROL
LIFEPAK 20E
38736503
7E129-1-UD
337879

PHYSIO CONTROL
LIFEPAK 20E
38736474
6N102-1-UD
337880

PHYSIO CONTROL
LIFEPAK 20E
38736463
4E125-1-UD
337881

PHYSIO CONTROL
LIFEPAK 20E
38736506
4N125-1-UD
337882

PHYSIO CONTROL
LIFEPAK 20E
38736459
6E135-1-UD
337883

PHYSIO CONTROL
LIFEPAK 20E
38736476
1M133-29-UD
337884

PHYSIO CONTROL
LIFEPAK 20E
38736511
8N106-1-UD
337885

PHYSIO CONTROL
LIFEPAK 20E
38736432
4E104-1-UD
337886

PHYSIO CONTROL
LIFEPAK 20E
38736478
3W211-1-UD
337887

PHYSIO CONTROL
LIFEPAK 20E
38736465
6N102-1-UD
337888

PHYSIO CONTROL
LIFEPAK 20E
38736453
BW252-1-UD
337889

PHYSIO CONTROL
LIFEPAK 20E
38736514
3E107-1-UD
337890

PHYSIO CONTROL
LIFEPAK 20E
38733134
BW252-1-UD
337891

PHYSIO CONTROL
LIFEPAK 20E
38736457
1E125-1-UD
337892

PHYSIO CONTROL
LIFEPAK 20E
38736469
3W237-1-UD
337893

PHYSIO CONTROL
LIFEPAK 20E
38736461
5A109-1-UD
337894

PHYSIO CONTROL
LIFEPAK 20E
38736368
11N104-1-UD
337895

PHYSIO CONTROL
LIFEPAK 20E
38736500
3E137-1-UD
337896

PHYSIO CONTROL
LIFEPAK 20E
38736485
11N104-1-UD
337897

PHYSIO CONTROL
LIFEPAK 20E
38736515
1A122-1-UD
337898

PHYSIO CONTROL
LIFEPAK 20E
38736508
3E122-1-UD
337899

PHYSIO CONTROL
LIFEPAK 20E
38736427
3W129-1-UD
337900

PHYSIO CONTROL
LIFEPAK 20E
38736518
5W155-1-UD
337901

PHYSIO CONTROL
LIFEPAK 20E
38736494
6W155-1-UD
337902

PHYSIO CONTROL
LIFEPAK 20E
38736504
2E146C-1-UD
337903

PHYSIO CONTROL
LIFEPAK 20E
38736480
4E118-1-UD
337904

PHYSIO CONTROL
LIFEPAK 20E
38736472
4N140-1-UD
337905

PHYSIO CONTROL
LIFEPAK 20E
38736477
5W136-1-UD
337906

PHYSIO CONTROL
LIFEPAK 20E
38736502
1NW114-1-UD
337907

PHYSIO CONTROL
LIFEPAK 20E
38736486
BA101-30-UD
337908

PHYSIO CONTROL
LIFEPAK 20E
38736460
4W136-1-UD
337909

PHYSIO CONTROL
LIFEPAK 20E
38736479
8E125-1-UD
337910

PHYSIO CONTROL
LIFEPAK 20E
38736471
4W136-1-UD
337911

PHYSIO CONTROL
LIFEPAK 20E
38736470
5E134-1-UD
337912

PHYSIO CONTROL
LIFEPAK 20E
38733144
10E115-1-UD
337913

PHYSIO CONTROL
LIFEPAK 20E
38736454
9W139-1-UD
337914

PHYSIO CONTROL
LIFEPAK 20E
38736488
2A234-1-UD
337916

PHYSIO CONTROL
LIFEPAK 20E
38736497
9C101-1-UD
337917

PHYSIO CONTROL
LIFEPAK 20E
38736456
8W111-1-UD
357212

PHYSIO CONTROL
LIFEPAK 20E
40456161
1M186-29-UD
376752

PHYSIO CONTROL
LIFEPAK 20E
42332771
5A109-1-UD
376753

PHYSIO CONTROL
LIFEPAK 20E
42332782
1NW114-1-UD
376754

PHYSIO CONTROL
LIFEPAK 20E
42332850
1NW114-1-UD
376755

PHYSIO CONTROL
LIFEPAK 20E
42332948
4E118-1-UD
376756

PHYSIO CONTROL
LIFEPAK 20E
42332996
3A126-1-UD
376757

PHYSIO CONTROL
LIFEPAK 20E
42333003
3E122-1-UD
376758

PHYSIO CONTROL
LIFEPAK 20E
42333085
AN316-1-UD
376759

PHYSIO CONTROL
LIFEPAK 20E
42333406
5A104-1-UD
376760

PHYSIO CONTROL
LIFEPAK 20E
42333480
4E120-1-UD
343789

PHYSIO CONTROL
LIFEPAK 20E
39189442
5M152-29-UD
348284

PHYSIO CONTROL
LIFEPAK 20E
39789903
3E135-1-UD
348285

PHYSIO CONTROL
LIFEPAK 20E
39797524
3A120-1-UD
348294

PHYSIO CONTROL
LIFEPAK 20E
39779267
AN316-1-UD
348295

PHYSIO CONTROL
LIFEPAK 20E
39789911
8E118-1-UD
348296

PHYSIO CONTROL
LIFEPAK 20E
39789891
4N115-1-UD
348297

PHYSIO CONTROL
LIFEPAK 20E
39789897
1NW121-1-UD
348298

PHYSIO CONTROL
LIFEPAK 20E
39789905
5A109-1-UD
359743

PHYSIO CONTROL
LIFEPAK 20E
40704902
5W136-1-UD
359744

PHYSIO CONTROL
LIFEPAK 20E
40704979
4W136-1-UD
359745

PHYSIO CONTROL
LIFEPAK 20E
40705046
4N109-1-UD
366084

PHYSIO CONTROL
LIFEPAK 20E
42090679
5A109-1-UD
382522

PHYSIO CONTROL
LIFEPAK 20E
44377847
9W110-1-UD
382611

PHYSIO CONTROL
LIFEPAK 20E
44506615
1W156-1-UD
343832

PHYSIO CONTROL
LIFEPAK 20E
39186611
3A188-1-UD
343833

PHYSIO CONTROL
LIFEPAK 20E
39186619
3A191-1-UD
343834

PHYSIO CONTROL
LIFEPAK 20E
39186620
3A172-1-UD
343835

PHYSIO CONTROL
LIFEPAK 20E
39177897
2M201-29-UD
343836

PHYSIO CONTROL
LIFEPAK 20E
39186615
4W155-1-UD
346731

PHYSIO CONTROL
LIFEPAK 20E
39544254
3W129-1-UD
3380492

PHYSIO CONTROL
LIFEPAK 20
33473771
5W136-1-UD
358757

PHYSIO CONTROL
LIFEPAK 15
40634662
7N101-1-UD
337839

PHYSIO CONTROL
LIFEPAK 15
38279200
4N110-1-UD
337840

PHYSIO CONTROL
LIFEPAK 15
38290133
4N109-1-UD
365043

PHYSIO CONTROL
LIFEPAK 15
41604841
4N114A-1-UD
365044

PHYSIO CONTROL
LIFEPAK 15
41604922
4N114A-1-UD
376761

PHYSIO CONTROL
LIFEPAK 15
42315519
6N102-1-UD
376762

PHYSIO CONTROL
LIFEPAK 15
42315579
3E122-1-UD
376763

PHYSIO CONTROL
LIFEPAK 15
42315713
5A109-1-UD
376764

PHYSIO CONTROL
LIFEPAK 15
42315826
3A120-1-UD
376765

PHYSIO CONTROL
LIFEPAK 15
42316371
1NW114-1-UD
376766

PHYSIO CONTROL
LIFEPAK 15
42316411
3A120-1-UD
376767

PHYSIO CONTROL
LIFEPAK 15
42316541
3E122-1-UD
376768

PHYSIO CONTROL
LIFEPAK 15
42316602
4E125-1-UD
376769

PHYSIO CONTROL
LIFEPAK 15
42315699
4E102-1-UD
365717

PHYSIO CONTROL
LIFEPAK 15
41748432
GA105-30-UD
353658

PHYSIO CONTROL
LIFEPAK 15
40160483
3E135-1-UD
356718

PHYSIO CONTROL
LIFEPAK 15
40450024
GM109-29-UD

PAYMENT:

Invoice must include the following information: Contract No., Purchase Order No., and itemized listing of all equipment installed by unit. Invoices can be issued per unit after full-functionality of system has been achieved and proven.

IDENTIFICATION, PARKING, SMOKING, AND VA REGULATIONS:

The Contractor's FSEs shall wear visible identification at all times while on the premises of the VA Medical Center (VAMC). It is the responsibility of the Contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police Section. The VAMC will not invalidate or make reimbursement for parking violations of the Contractor under any conditions. Smoking is prohibited throughout all VA campuses. Violations will result in citations. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.

The Contractor shall be required to report to Biomedical Engineering to log in. This check in is mandatory. When the service is completed, the FSE shall document services rendered on a legible ESR(s). The FSE shall be required to log out with Engineering and submit the ESR(s) to the COR. All ESRs shall be submitted to the equipment user for an "acceptance signature" and to the COR for an "authorization signature". If the COR is unavailable, a signed, authorized copy of the ESR will be sent to the Contractor after the work can be reviewed (if requested or noted on the ESR).

PROTECTION OF EXISITING STRUCTURES, EQUIPMENT, AND UTILITIES:

The Contractor shall preserve and protect all structures and equipment on or adjacent to the work site. The contractor shall replace at his own expense damage to such items to the satisfaction of the Contracting Officer.

Contractor shall take all measures and provide all materials necessary for protecting and preserving existing equipment and property in affected areas of installation against dust, debris and physical damage, so that equipment and affected areas to be used in Medical Center operations will not be hindered. Contractor shall permit access to VA personnel through installation areas as required for maintenance and normal Medical Center operations.

PHASING:

The contractor shall submit a delivery schedule in writing to the COR for approval up to four weeks prior to the start of any work.

VAPHS is a fully operational hospital. The Contractor must schedule his work around VA operations and specifically for the convenience of the hospital. Contractor must not work at times other than normal operating hours, which are from 08:00 until 16:00 Monday through Friday.

All work and installation will be coordinated with the COR, Clinical, and Engineering groups. Phasing and work schedule will be provided and coordinated with the COR. A detailed delivery/installation schedule will be provided during the project implementation kick-off meeting. The uninstallation and installation will occur at the discretion of the COR and be coordinated with the VA. The full deployment shall have a 90-day deployment window. In addition to the COR, an additional representative at the facility will act as a liaison to ensure that the vendor meets government expectations and follows the guidelines as set by the Contracting Officer. Vendor will have no access to VA sensitive information during the installation.

The vendor will confine operations (including storage of materials) on Government premises to areas authorized and approved by the Contracting Officer. The Contractor shall hold and save the Government, its officers and agents, free and harmless from liability of any nature occasioned by the Contractor s performance. Working space and space available shall be as determined by the COR.

CONTRACTOR S RESPONSIBILITY IN CONNECTION WITH PROJECT:

The price quoted shall include removal of existing defibrillators (one existing defibrillator to every new defibrillator). Contractor must coordinate with the Logistics department to ensure proper turn-in protocols are followed.

No more than 30 days prior to delivery logistics will need all incoming defibrillator serial numbers, IndividualB cost per defibrillator, model number, & manufacture name.
All defibrillators will be tagged & installed if necessary by vendor in designated area in the warehouse prior to defibrillators being transported for delivery.
Vendor will not remove any existing defibrillator until all Electronic Equipment (EE) tags & room numbers of defibrillator have been recorded and given to logistics.
Vendor will remove and dispose of all existing defibrillators at no additional charge to the VA. (VA would like to receive fair Market ValueB of all existing defibrillators as a trade in price or deduction off total price).

Once installation is started, it shall be continuous, eight (8) hours per day coinciding with the day shift working hours at the hospital. Compliance with this requirement shall be manifest by the continuous presence of the engineers or technicians on the job site during the daily working period. Installation shall be continuous, without interruption, until all installation and testing work has been completed. The contractor must provide the physical movement of the equipment from the storage point at final destination, to the area of installation, and the uncrating of the equipment.

Upon receipt of notice to proceed with installation, it shall be the contractor's responsibility to inform the Contracting Officer of any problems which may be anticipated in connection with installation or which will affect optimum performance once installation is completed. Such matters as inadequacy of power supply, limitations of site or inadequate preparation of site shall be reported prior to start of installation. Installation shall not proceed under such circumstances until authorized by the Contracting Officer.

In the event that progress of the installation is interrupted through no fault of the contractor, the continuous installation referenced in the preceding paragraphs may be terminated until such time as the cause of delay has been eliminated, and then shall be resumed within twenty-four (24) hours after the contractor has been notified that work may again proceed. Such termination of continuous installation shall be made only after two (2) hours notice has been given to the (COR) or person acting in that capacity at the hospital receiving installation. Contractor must notify the Contracting Officer within 48 hours of termination of installation.

Unless otherwise authorized by the Contracting officer, installation of equipment shall in no event exceed sixty (60) days per room from the date of notice to proceed with installation.

TRAINING:

Clinical users:

The successful vendor, at the time of a purchase, will provide, training for all shifts. This will require more than one training session per shift, no more than three weeks prior to installation. Training would include initial training; go live support training, super user training, and Computer Based Training.

Biomedical Engineering Service Training:

The vendor shall provide, at no cost to the hospital, in-service training for 10 in-house Biomedical Engineering employees included in the purchase of each major piece of equipment in at least two sessions. This training shall be equal to the training provided by the manufacturer for their service personnel and will train the designated in-house personnel on the calibration, maintenance, and repair of the entire system purchased. The training shall include all components, peripherals, travel and expenses. This training shall be available for a date prior to the expiration of the warranty period of the purchased equipment.

LICENSING SOFTWARE REQUIREMENTS:

The vendor shall provide 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 quote and required for maintenance of the system, shall be taken as included with the purchase of the system. Any 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. All application software licenses are included in the purchase of the equipment and shall not a require renewal charge for the period of time the equipment is in use in the facility.

CLEANING REQUIREMENTS:

All defibrillators must be able to be cleaned by PDI, Cleancide, Wexcide, and Bleach.

USER AND SERVICE MANUALS:

The vendor shall provide, at no charge, (2) complete and unabridged sets of operator manuals, service manuals, electronic schematics, troubleshooting guides and parts lists for each piece of equipment purchased to each medical center. These manuals will include all components and subassemblies, including those not manufactured by the vendor. These manuals and documentation shall be identical to the ones supplied to the manufacturer s service representatives and shall contain the diagnostic codes, commands, and passwords utilized in maintenance, repair and calibration of the equipment. The vendor shall disclose at the time of quoting of this equipment any post warranty charges such as remote service or application access charges, telephone technical or application support charges, or any fees associated with supporting this equipment including the hourly rate for onsite maintenance service, and the cost and description of the various maintenance coverage products.

WARRANTY SERVICE:

Duration: Contractor must provide standard warranty (minimum of one year) after COR review and signature for completion of project. Extended warranty shall be provided for a total of five years. Warranty will cover parts and labor completed by the Contractor.

Response Time: - Contractor's FSE must respond with a phone call to the COR or his/her designee within two (2) hours after receipt of telephoned notification twenty-four (24) hours per day. If the problem cannot be corrected by phone, the FSE will commence work (on-site physical response) within two (2) hours after receipt of this second notification and will proceed progressively to completion without undue delay

The Contractor shall immediately, but no later than 24 (twenty-four) consecutive hours after discovery, notify the CO and COR (in writing) of the existence or the development of any defects in, or repairs required, to the scheduled equipment which the Contractor considers he/she is not responsible for under the terms of the contract. The Contractor shall furnish the CO and COR with a written estimate of the cost to make necessary repairs.

SERVICE PRIOR TO AND DURING GUARANTEE PERIOD:

Prior to and during the guarantee period, service at other than normal working hours (8:00 a.m. - 5:00 p.m., excluding weekends and holidays), if at the request of the hospital, will be charged at an hourly rate which is the difference between current regular rate and premium rate. Otherwise, all services will be performed at no charge to the Government during this period.

SAFETY DATA SHEET (SDS):

Contractor shall provide three (3) copies of each Safety Data Sheet (SDS) for every product, chemical, etc. used on this project. SDS sheets shall be provided for any material on the same day those materials arrive on VA property. At no time shall the contractor have, or permit subcontractors to have, materials on station without MSDS sheets. All instructions for use shall be followed. Products will not be used until SDS's are submitted to the COR.

SERVICE BULLETINS:

Two (2) copies of each service bulletin affecting safety or maintenance of equipment furnished under this contract will be forwarded to the receiving activity for a period of ten (10) years after date of delivery.

HARDWARE UPGRADES:

All equipment and related peripherals contracted for shall be state-of-the-art technology. "State-of-the-art" is defined as the most recently designed components that are announced for marketing purposes, available, maintained and supported in accordance with mandatory requirements specified in the solicitation. Components and products with a manufacturer's planned obsolescence within the first year of contract award are not acceptable. If hardware upgrades become available after award of this contract but prior to installation of the equipment, the contractor is requested to offer them to the Contracting Officer for consideration. The contractor's proposal for such upgrades shall include the following information:

Pricing information, to include both the price of the equipment to be added and the equipment to be deleted.
Specific awarded items that shall be changed if the proposal is awarded.
Performance data, including both comparisons to the specification requirements and to the equipment on contract.
A detailed description of the differences between the awarded items and those being proposed, and a specific analysis of the comparative advantages/disadvantages of the items involved.
An evaluation of the effect proposed changes will have on the life cycle of the equipment and an associated cost impact as it relates to site preparation, installation, maintenance, and operational expense.
An analysis of the timeframe required to institute the change

INFLUENZA VACCINATION:

VHA Directive 1192 requires all health care personnel (HCP) to participate in the seasonal influenza prevention program and outlines the key implementation steps. Health care personnel is defined in VHA Directive 1192 as all VA licensed and unlicensed, clinical and administrative, paid and unpaid, full- and part-time employees, intermittent employees, fee basis employees, VA contractors, students, researchers, volunteers, and trainees who work in VHA locations. HCP covered by the policy are expected to receive annual influenza vaccination. This requirement is extended to all Contractor personnel with potential to come into minimal contact (passing in the corridor) with any patients, visitors, or staff members at VAPHS.

Those individuals unable or unwilling to be vaccinated are required to wear a face mask throughout the influenza season. Masks are available at entrances throughout the medical center.

It is the responsibility of the contractor to ensure that all contract staff is compliant with the requirements outlined in VHA Directive 1192. The contractor shall maintain the following documentation:

- Documentation of vaccination, e.g., signed record of immunization from a health care provider or pharmacy, or a copy of medical records documenting the vaccination.

- Completed Health Care Personnel Influenza Vaccination Form (Attachment B of VHA Directive 1192) if unwilling or unable to receive the vaccine.

The contractor is required to submit annual certification in the form of a memorandum to the Contracting Officer s Representative (COR) that all contract staff performing services at VA facilities is in compliance with VHA Directive 1192.


TUBERCULOSIS PREVENTION:

Standard Personnel Testing (PPD, etc.): Contractor shall provide proof of the following tests for personnel within five (5) calendar days after contract award and prior to the first duty shift to the COR and Contracting Officer.B Tests shall be current within the past year.

TUBERCULOSIS TESTING:B Contractor shall provide proof of a negative reaction to PPD testing for all contract personnel.B A negative chest radiographic report for active tuberculosis shall be provided in cases of positive PPD results.B The PPD test shall be repeated annually.
RUBELLA TESTING:B Contractor shall provide proof of immunization for all contract personnel for measles, mumps, rubella or a rubella titer of 1.8 or greater.B If the titer is less than 1.8, a rubella immunization shall be administered with follow-up documentation to the COR.
Please provide a signed memo stating that:
(number of assigned Key Personnel) assigned to VA Contract #___________ have tested negative for tuberculosis within the past 365 days.
(number of assigned Key Personnel) assigned to VA Contract #___________ have been immunized for measles, mumps, rubella or a rubella titer of 1.8 or greater.


End of Scope of Work


SECURITY INFORMATION:
A compliant ID badge must be worn by Contractors at all times while on VA premises.
Contractor may not have access to the VA network or any VA sensitive information under this contract. No Business Associate Agreement is required.
All Contractors must receive Privacy training annually using one of the following methods:
Complete VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access to or Use to VA Sensitive Information training by using VA s TMS system (https://www.tms.va.gov/SecureAuth35/). Contractors may use the TMS Managed Self Enrollment method to complete the training in TMS. The COR must ensure that all contractors are validated in the PIH domain.
Complete the hard copy version of VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access to or Use to VA Sensitive Information . Signed training documents must be submitted to the COR.
Training must be completed prior to the performance of the contract and annually thereafter. Proof of training completion must be verified and tracked by the COR
RM Comments: Records Management Language is not required.



(viii) The provision at 52.212-1, Instructions to Offerors -- Commercial, applies to this acquisition and the following clauses AND instructions are added as addenda:

CLAUSES:
52.211-6 Brand Name or Equal (AUG 1999)
52.214-21 Descriptive Literature (APR 2002)
852.211-73 Brand Name or Equal. (JAN 2008)
852-219-10 VA Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside
(a) Gray market items are Original Equipment Manufacturer s (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts) for VA Medical Centers.B No remanufactures or gray market items will be acceptable.
B
(b) Vendor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts), verified by an authorization letter or other documents from the OEM, such that the OEM s warranty and service are provided and maintained by the OEM.B All software licensing, warranty and service associated with the medical supplies, medical equipment and/or services contracts for maintenance of medical equipment shall be in accordance with the OEM terms and conditions. Offerors must submit proper authorization or other pertinent documentation at the time of submitting a response to this combined synopsis/solicitation in order to be considered for award.
(c) The delivery of gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract.B Accordingly, the VA reserves the right enforce any of its contractual remedies. This includes termination of the contract or, solely at the VA s election, allowing the Vendor toB replace, at no cost to the Government, any remanufactured or gray market item(s) delivered to a VA medical facility upon discovery of such items.B

(ix) Evaluation of this requirement will be based on TECHNICAL CAPABILITY AND PRICE.
(x) Offerors are advised to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Items, with its offer if has not been completed on SAM.gov.
(xi) The clause at 52.212-4, Contract Terms and Conditions -- Commercial Items, applies to this acquisition and the following clauses are added as addenda:
(End of Clause)
52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)
This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these addresses:

http://farsite.hill.af.mil
https://acquisition.gov/far
(End of Clause)

852.203-70 Commercial Advertising (JAN 2008)
852.232-72 Electronic Submission of payment Requests.(NOV 2018)
852.246-71 Rejected Goods (OCT 2018)
852.247-74 Advance Notice of Shipments (OCT 2018)
852.270-1 Representatives of Contracting Officers (JAN 2008)

(xii) The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items, applies to this acquisition and the following additional FAR clauses cited in the clause are applicable to the acquisition:
52.204-10 Reporting Executive Compensation & First-Tier Subcontract Awards (OCT 2015)
52.209-6 Protecting the Government s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (OCT 2015)
52.209-7 Information Regarding Responsibility matters (OCT 2018)
52.212-1 Instructions to Offerors COMMERCIAL ITEMS (OCT 2018)
52.219-28 Post Award Small Business Program Representation (JUL 2013)
52.222-19 Child Labor--Cooperation with Authorities and Remedies (FEB 2016) (E.O. 13126)
52.222-21 Prohibition of Segregated Facilities (APR 2015)
52.222-26 Equal Opportunity (APR 2015)
52.222-36 Equal Opportunity for Workers with Disabilities (JUL 2014)
52.222-50 Combating Trafficking in Persons (MAR 2015)
52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011)
52.225-3 Buy American--Free Trade Agreements--Israeli Trade Act (MAY 2014)
52.225-13 Restrictions on Certain Foreign Purchases (JUNE 2008)
52.232-34 Payment by Electronic Funds Transfer--Other than System for Award Management (JUL 2013)
52.232-40 Providing Accelerated Payments to Small Business Subcontractors
52.252-1 Solicitation Provisions Incorporated by Reference (FEB 1998)





(xiii) Additional conditions:

All responses must include verification that each specification outlined in Section (vi) is met.
All interested parties shall be registered, active and verified with the following sites to be considered for award.
SAM: http://www.sam.gov
VETBIZ https://www.vip.vetbiz.gov/Public/Search/Default.aspx
(xiv) The Defense Priorities and Allocations System (DPAS) ratings are NOT APPLICABLE.
(xv) Quotes must be emailed to ronald.kline@va.gov and received no later than 12:00 pm EST on the close date, August 22, 2019. Quotes may be submitted on this document or the vendor s own form. When submitting a quote using this document, must include: Business Name, address and point of contact (POC).
(xvi) For information regarding the combined synopsis/solicitation, please contact Ronald Kline at ronald.kline@va.gov

END OF DOCUMENT

Ronald Kline

Ronald.Kline@va.gov

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