VA242-17-Q-0580|Hysteroscopic Tissue Removal System|SDVOSBset-aside
TITLE: 65-Combined Synopsis/Solicitation
SOL: VA242-17-Q-0580
DUE: 05/31/2017, 12 PM Midnight EST
SET ASIDE: SDVOSB set-aside
NAICS: 339112--Surgical and Medical Instrument Manufacturing
POP STATE: United States
AGENCY: Department of Veterans Affairs, VA New York Harbor Healthcare System
423 East 23rd St, New York NY 10010
POC: Shari Lee; shari.lee@va.gov
Mail all responses only to: Shari Lee at shari.lee@va.gov
DESCRIPTION: This Sources Sought Notice is for Service Disabled Veteran Owned Businesses only. Quotes and responses will only be accepted from SDVOSB s who are VETBIZ certified through the VETBIZ website: https://www.vip.vetbiz.gov/. The NAICS code is 339112 and the size standard is 1000 employees. The following RFQ is seeking these items for the Manhattan VA Medical Center, 423 East 23rd Street, New York, NY 10010
TruClear Hysteroscopic Tissue Removal System
The contractor shall provide all labor, equipment, supplies, materials, engineering design, and supervision to design, manufacture, and deliver this equipment. Design and delivery shall be coordinated with the Service Point of Contact Personnel, to be revealed after contract award has been determined.
PHYSICAL ITEMS NEEDED:
1) Must have the minimum of the following: (14 parts are needed)
Item Code 7209807; Trueclear Handpeice; Quantity needed (2)
Item Code 7209808; Trueclear Control Unit; Quantity needed (1)
Item Code 7209820; Trueclear Footswitch; Quantity needed (1)
Item Code 72202710; Hysteroscopic FMS Kit, U.S., Quantity needed (1)
Item Code 7210164; Hyst. Fluid Mgmt System Control Unit; Quantity needed (1)
Item Code 7210165; Hyst. Fluid Mgmt Stand; Quantity needed (1)
Item Code 7210166; Hyst. Fluid Mgmt Roller Base; Quantity needed (1)
Item Code 72203420; Vacuum Regulator PM 76 MM; Quantity needed (1)
Item Code 7209208; Operative Hysteroscope; Quantity needed (1)
Item Code 7209383; Trueclear Sheath 9.0; Quantity needed (1)
Item Code 7209384; Trueclear Obturator, Quantity needed (1)
Continued
List continued .
Item Code 72204752; Trueclear Operative Hysteroscope 5C, Quantity needed (1)
Item Code 72204753; Trueclear Sheath 5C, Quantity needed (1)
** End of Parts needed.
Objective
The service is in need of a Hysteroscopic Tissue Removal system that pairs the visualization capabilities of a hysteroscope with minimally invasive tissue removal capabilities that will allow for a fast and thorough capture and removal of intrauterine polyps and fibroids; and provides healthcare practitioners in obstetrics, gynecology and reproductive health with a uniquely user-friendly technique. The system should be optimized to thoroughly and efficiently remove tissue so that physicians will not be required to make multiple, time-consuming insertions into the uterine cavity. The system needs to be designed to cleanly remove tissue from the uterine cavity, leaving the hysteroscopic view unobscured and ultimately allows healthcare practitioners greater clarity to complete a given procedure. It also must have an enhanced capability to perform/treat a full spectrum of conditions, including:
Hysteroscopic Adhesiolysis
Removes intrauterine adhesions under direct visualization
Designed to reduce damage to surrounding healthy endometrium
Myomectomy
Brings speed, efficiency and precision to the removal of myomas
Helps ensure patient safety through advanced fluid management
Retained Products of Conception Evaluation
Minimizes endometrial damage and reduces risk of intrauterine adhesions by evacuating RPOC under direct visualization.
Captures tissue for histological confirmation
May reduce the need for additional procedures as the system has demonstrated complete removal in over 94% of patients
Polypectomy
May improve the efficiency of polyp removal by reducing polypectomy procedure time by half2 that of electrical resection
More likely to completely remove polyps compared to electrical resection
Minimizes patient discomfort
Diagnostic Visual D&C and Endometrial Biopsy
Provides direct visualization of the uterine cavity, facilitating removal of targeted endometrial tissue, hyperplastic endometrium or other intrauterine tissue for pathology analysis.
Requirements
Operative Hysteroscope Set
Smallest instrumentation that is available today; 5.0 mm scope and 5.6 mm sheath require little to no dilation.
Mechanical energy means no electrical energy in the uterus while also reducing the risk of air or gas emboli
Targeted pathology removal under continuous visualization ensures efficient cut and capture.
100% tissue capture allows evaluation of entire pathology
Longer scope and blade means access to the entire uterus, including the cornua and fundal wall
Continuous cutting and tissue removal means no chips interfering with visualization
Dual outflow with true continuous flow, 100% of the time, to allow clear visualization
Hysteroscopic Tissue Removal System
Simple, mechanical design means there is no risk of energy discharge-induced scarring and a reduced risk of air or gas emboli compared to conventional resection
Localized treatment reduces endometrial damage, which may help preserve the chances of pregnancy
Enhanced suction control technology to minimize fluid use
Continuous visualization ensures efficient cut and capture
Tissue capture allows evaluation of the entire pathology
Hysterescopic Fluid Management System
Maximum flow rate of 700 ml/min optimizes visualization
Allows intrauterine pressure to be maintained at the desired level
Scale continuously monitors fluid deficit for accurate measurements
Controlled suction to provide suction flexibility in order to maintain clear visualization
Reliable Warning Systems for safety to indicate over pressure, under pressure and fluid deficit thresholds
Place of Delivery
The product(s) will be delivered to:
VA New York Harbor Healthcare System
423 East 23rd St, New York NY 10010
Product Installation (If Applicable)
The vendor shall be responsible for determination of and compliance with federal and state or local code requirements, design data, and other factors necessary to install or deliver the items at the desired location.
The system will not require any new construction, space, special wirings etc.
Training Of Operating personnel (If Applicable)
(a) The price quoted shall include contractor responsibility for providing on-site orientation and training of using personnel in operation and care of the equipment furnished. This training shall include actual demonstration and operation of the equipment, preventative maintenance, and any adjustments or other actions which may be undertaken by operating personnel in the event of failure of equipment, provided that such adjustment or action shall in no way jeopardize the Government's rights under contract guarantee clause. Upon completion of installation, this training shall be given by qualified contractor representatives on a date to be determined by the using service POC. Operator and maintenance training shall not be conducted concurrently.
(b) Vendor shall submit training materials and training videos (prepared in CD or DVD format) on each piece of equipment for operation and maintenance. Any available training videos shall be for operation and maintenance and shall not be combined. These training materials and videos shall demonstrate the operation and maintenance of the equipment and any adjustments or other actions that may be undertaken by VA operating personnel in the event of failure of equipment. These training materials and videos shall be submitted to the responsible operations official or his designee prior to beginning of training.
(c) The Vendor shall consult with the Contracting Officer Representative or person acting in that capacity regarding the time this training will begin. These officials will be responsible for arranging for the presence of personnel to be trained.
Warranty & Service contract
Unit shall come with a standard 1 year warranty, as well as a 1 year service contract after the warranty expires. This will include remote phone support and repair of unit (parts and labor).
All contractor employees and subcontractors participating under this contract or order, to provide installation, training or service repairs are required to complete the VA's Privacy and Information security training requirement - VA Privacy and Information Security Awareness and Rules of Behavior Training B -B TMS Code 10176
Contractors must provide signed certifications of completion to the COR during each year of the contract.B This requirement is in addition to any other training that may be required of the contractor and subcontractor(s).
THIS IS A SOLICITATION AND A CONTRACT WILL FOR CREATED BASED ON THE QUOTES RECEIVED BY THE CLOSE DATE. THIS CONTRACT WILL BE AWARDED TO THE LOWEST BID TECHNIALL Y ACCEPTABLE UNDER FAR 15.304(d). The applicable North American Classification System (NAICS) Code for this requirement is 339112 (Surgical and Medical Instrument Manufacturing). The size standard is 1000 employees. Email should contain the RFQ filled out where applicable, and your quoted. The email that you sent to Shari.Lee@va.gov must contain the words VA242-17-Q-0580 Hysteroscopic Tissue Removal Kit-RFQ in the subject box.
**Note: All SDVOSB/VOSB vendors who plan on competing for this stated acquisition must be VIP Verified at https://www.vip.vetbiz.gov/. To properly apply the VA Rule of Two 38 U.S.C. 8127 (d) Supplies and Services to procurements for SDVOSB set-asides, Contracting Officers are required to verify that all SDVOSB/VOSBs who are interested parties are VIP Verified during entire acquisition process. Only offers from Certified VETVIZ SDVOSB Vendors will be considered or accepted. Thank You**
Shari Lee
shari.lee@va.gov
contract officer
