36C25819Q0489-003.pdf

ATTACHMENT 02

Performance Work Statement

CLIN 0015 thru 0016

5 pages

12 September 2019

San Diego, California VA Health Care System (664)

Ophthalmology Equipment

Supply

(PHACO Machine) {SEPG#136892// EER#71059}

Performance Work Statement

{PHACO Machine} (Surgical Service)

Phoenix Veterans Administration Health Care Services

650 E. Indian School Road Phoenix, AZ 85012

Equip:

POC: Bruce Potenza MD. x7798 COR: Chester Greathouse x7930

1.0 Scope of Work (Purpose)

The purpose of this performance work statement is to procure an {PHACO Machine} for Surgical Service Department in the Phoenix VA Medical Center. We are beginning an operative ophthalmology program at the Phoenix VA. In order to accomplish this we will need to invest in the equipment to perform the surgical procedures for the veteran population. Most of the use of this microscope will be for cataract and retinal surgical procedures..

Cataract surgery is a very common ophthalmologic surgical procedure. This Phacoemulsificaiton technology is one of the main pieces of equipment needed for cataract surgery, along with the operating microscope. The PHACO machine is used during the procedure after the surgeon has incised a small area to place a tiny probe where ultrasonic phaco energy is used to fragment the cataract. The debris is then removed from the operative field and a new corneal lens is placed and sutured in place.

The contractor shall provide the equipment in accordance with this description of specification and other requirements of this request.

2.0 Specifications & Equipment Description:

a. Dimensions:

1. Height no greater than 70 inches

2. Width no greater than 25 inches

3. Weight no greater than 250 lbs

b. IR Remote control

i. 6 channels

c. Foot switch

d. Console stability

e. AC requirements

i. Input voltage 100-240 VAC

ii. Max input current 10A

iii. Protection against electrical shock

f. Data card-USB data stick 8 GB or greater

g. Phacoemulsification handpiece

i. Sub modes: continuous, burst and pulse

ii. Longitudinal tip stroke @ 100%.0084+/- .0018 cm

iii. Resonant frequency:30 kHz

iv. Torsional tip stroke @100% .0069 +/-.0023

v. Pulse rate range:1-250 pps

vi. On time:0-100%

vii. Burst on time 2-500 mS

viii. Burst time off 2500-0 mS

h. Anterior vitrectomy

i. Auto modes: anterior vit, epi removal, I/A Cut, Peripheral Irid, Vasco-Asp

ii. Centurion ultra Vit Probe 1-4000 cpm

i. Diathermy coagulation

i. 10 watts max, 75 ohm

ii. 76 Vpp@1.5 MHz +/- 75 oHm

iii. Waveshape: sinusoidal

j. Vacuum sea level

i. Phacoemulsification: 0-650 nn Hg

ii. Vitrectomy: 0-650 mmHg

iii. Irrigation/Aspiration 0-650

k. Power IV pole

l. IOP controlled infusion

i. Range 20-110 mmHg

ii. Accuracy +/- 15mmHg

iii. Aspiration flow rate:0-60 cc/min

iv. Usable fluid volume: > or + to 350 cc

m. Voice confirmation

i. Range 0-60 dB

n. Tone volumes @ 1 meter

i. Faults:65 dB short tone

ii. Diathermy: 50-65 dB continuous tone

iii. Phaco/Vacumm level: 50-65 dB continuous tone

iv. Phaco Occlusion 50-65 dB double chime

o. Proportional and continuous reflux @sea level

i. Pressure range 20-140 mmHg

ii. Pressure accuracy 10% setpoint

p. Intrepid autosert IOL injector

i. Max speed 4.4 mm/sec

3.0 Delivery and Shipping Information. The contractor shall provide the following for shipment and delivery of equipment:

3.1 The Contractor shall ship the procurement/item to 650 E. Indian School Road, Room 1153, Phoenix, AZ 85012.

3.2 The Contractor shall be responsible for assessing the Medical Center for all requirement cabling and other equipment needed for installation.

3.3 The contractor will disassemble and remove the old machine to the dock, uncrate and set up the new machine in place, and assemble the new unit and make all internal connections.

3.4 The contractor will re-connect the new unit to the existing utilities and perform the start-up check to ensure proper function.

3.5 The Contractor will consult and coordinate with the in-house engineering group to gain access to restricted areas.

3.6 All installation plans will be reviewed and signed off on by the project COR and engineering representative.

4.0 System Documentation:

4.1 The contractor’s proposal shall provide a complete set of unabridged operator manuals, service manuals, electronic schematics, troubleshooting guides, and parts lists for each piece of equipment which is part of the system procured by the

MC.

4.2 The contractor’s proposal shall provide a complete set of manufacturer’s cleaning guidelines/instruction for each system component that is used.

5.0 Warranty:

5.1 The contractor shall provide the standard 12- or 24-months warranty; with an option to purchase an extended warranty of 3-5 years that will cover all parts, labor, supplies, travel costs, and user support at no additional cost to PVAHCS.

6.0 Period and Place of Performance:

The system must ship within 30 days as this is an essential piece of equipment for the hospital.

7.0 Operating Constraints:

7.1 All installation and implementation work must be completed after regular business hours and on weekends due to infection control concerns and/or the impedance of patient care. The hours for installation will be coordinated/agreed upon prior to installation.

7.2 PVAHCS must have discretion to defer/hold any installations, if locations are not accessible for the installation process.

8.0 Security Requirements:

8.1 In reference to VHA Handbook 6500.6 Appendix A, Blocks 6 and 7, the equipment included in this contract does not capture and process ePHI over the hospital network.

8.2 In reference to VHA Handbook 6500.6 Appendix A, Block 6, the equipment (or service) included in this contract does not involve connection of IT devices to a VA network. Therefore, C&A, SAP, & the following from App C do not apply.

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

8.4 During install, training, warranty repair and/or maintenance provided by the contractor, they may have physical administrative access to the equipment included in this contract that capture and process ePHI. If warranty repair is done off-site, all hard drives or other data storage devices will be removed or purged of data, prior to release to contractor.

8.5 Privacy and HIPAA Focused Training Web-Based (WBT): VA Course No.

VA10203 is the official privacy training for VA employees, contractors, and volunteers who have access to protected health information (PHI) in the performance of their official duties or have access to VA systems (e.g. CPRS or VistA Web). All contracted employees will complete this training prior to being granted access to the subject equipment, or to the data therein. The training is available on the VA TMS website at: https://www.tms.va.gov. Contractor will provide evidence of training to the COR, if requested.