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SAMDAILY.US - ISSUE OF APRIL 09, 2021 SAM #7069
SOLICITATION NOTICE

65 -- COMPLETE HOLOGIC SYSTEMS/ABQ

Notice Date
4/7/2021 7:26:33 AM
 
Notice Type
Combined Synopsis/Solicitation
 
NAICS
334517 — Irradiation Apparatus Manufacturing
 
Contracting Office
258-NETWORK CNTRCT OFF 22G (36C258) MESA AZ 85212 USA
 
ZIP Code
85212
 
Solicitation Number
36C25821Q0151
 
Response Due
4/14/2021 11:00:00 AM
 
Archive Date
06/13/2021
 
Point of Contact
Tim Garrity, Contract Specialist, Phone: (480) 466-7937
 
E-Mail Address
timothy.garrity@va.gov
(timothy.garrity@va.gov)
 
Small Business Set-Aside
SDVOSBC Service-Disabled Veteran-Owned Small Business (SDVOSB) Set-Aside (FAR 19.14)
 
Awardee
null
 
Description
Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued. This solicitation is issued as an RFQ. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2021-05 (eff. 03/10/2021). This solicitation is set-aside for SDVOSB for BRAND NAME ONLY equipment. The associated North American Industrial Classification System (NAICS) code for this procurement is 334517 Irradiation Apparatus Manufacturing, with a small business size standard of 1000 Employees. The FSC/PSC is 6515 Medical and Surgical Instruments, Equipment, and Supplies. The New Mexico VA Medical Center is seeking to purchase BRAND NAME ONLY Hologic Myosure and Novasure devices as well as the Fluent fluid management system to include an extended 3-year warranty. All interested companies shall provide quotations for the following: Supplies/Services Line Item Description Quantity Unit of Measure Unit Price Total Price 0001 BRAND NAME ONLY Hologic RFC2010-115 RF Controller Model 10 1 EA 0002 BRAND NAME ONLY Hologic FLT-100 Fluent System 1 EA 0003 BRAND NAME ONLY Hologic 60-903 Omni Rod Lens Hysteroscope Instrument Tray 3 EA 0004 BRAND NAME ONLY Hologic 60-250-1 Omni Scope Standard Kit 3 EA 0005 BRAND NAME ONLY WAR-00002 Fluent Ext 3 Year Warranty 1 EA 0006 BRAND NAME ONLY WAR-0003 Novasure Ext 3 Year Warranty 1 EA STATEMENT OF WORK (SOW) As of 03/12/2021 Complete Hologic Fluent System Contract Title. The NMVAHCS GYN/surgical services requests procurement of the following equipment from Hologic to include the Myosure (hysteroscope) and Novasure (ablation) devices as well as the Fluent fluid management system and extended 3-year warranty. Acquiring compatible systems and devices allow less equipment and assists in controlling OR space and any future training of physicians and OR staff. Current physician is trained using these devices. Background. The NMVAHCS GYN service requests the Hologic Fluid System for use in the operating room for direct patient care. NMVAHCS has never had a GYN surgeon in the past and we have a new surgeon and anticipate adding 2 more. The surgeons require this system to provide standard of care to our female veterans equal to care received in private practice. Scope. The NMVAHCS GYN/ surgical service requests the Hologic Fluid System with compatible Hysteroscopes and Endometrial Ablation controller for use in the operating room for direct patient care. NMVAHCS has never had a GYN surgeon in the past and we have a new surgeon and anticipate adding 2 more. The surgeons require this system to provide standard of care to our female veterans equal to care received in private practice. The Fluent system supports hysteroscopy as it provides a safe and easy way to manage the amount of fluid losses from hysteroscopy since fluid is required to distend the uterine cavity to complete the procedure. The uterus is a very vascular structure and fluid can be absorbed into the patient s system at time of operative hysteroscopy which can lead to significant complications related to fluid overload if not monitored properly. This equipment is an essential part of diagnosing and treating our female patients safely. Specific Tasks. The equipment requested from Hologic includes the Myosure (hysteroscope) and Novasure (ablation) devices as well as the Fluent fluid management system and extended 3-year warranty. Acquiring compatible systems and devices allow less equipment and assists in controlling OR space and training of physicians and OR staff. Hysteroscopes allow visualization of the uterine cavity and can be used for diagnostic purposes as well as for r treatment of uterine pathology. A basic tool of a gynecologist is the hysteroscope as it can be used for patients of all ages and can evaluate for many different GYN issues from abnormal uterine bleeding to fibroids and polyps as well as postmenopausal bleeding. Whenever possible office hysteroscopy is preferred to avoid the OR and anesthesia. However, appropriate OR tools are also needed if a patient is unable to have an office procedure (due to physical or emotional barriers) or characteristics of the procedure itself require anesthesia and more robust tools. Larger polyps and fibroids in the uterine cavity are not easily removed with office hysteroscopy and therefore should be scheduled for the OR. The Fluid Management Fluent system supports hysteroscopy as it provides a safe and easy way to manage the amount of fluid losses from hysteroscopy since fluid is required to distend the uterine cavity to complete the procedure. The uterus is a very vascular structure and fluid can be absorbed into the patient s system at time e of operative hysteroscopy which can lead to significant complications related to fluid overload if not monitored properly. This procedure that removes the uterine lining while preserving the uterus to reduce or eliminate bleeding. The Fluid Management system be a touch screen-mobile system with a location to connect the Myosure hysteroscopes with all in one procedure kits requiring less equipment to control OR space. The Endometrial Ablation Controller requested is the Novasure . The EA procedure is performed as a minimally invasive, one-time, OR procedure and requires no inpatient stays. This allows a quick, easy, and safe option for women suffering with abnormal/heavy menstrual bleeding. Women presenting with abnormal and heavy bleeding are candidates for an ablation and should be available as an option for treatment given its low risks, quick recovery, and excellent outcomes (90% satisfaction rate). Must have/be: Hysteroscope device must be supported and compatible with the fluid management system and can be used together. Devices must be FDA approved Include scope and instrument trays compatible with the selected devices. Include extended warranties on both selected devices to ensure immediate and constant care of devices that will be used frequently by multiple surgeons. Endometrial Ablation controller must be touch screen and include AC power cord, footswitch, suction line, and canister. Endometrial Ablation device must be sterile, single-patient use device, a 3-dimensional bipolar electrode, deliver continuous suction to the endometrium while simultaneously removing steam, blood, vaporized tissue and other by products. The device must be compatible with the Endometrial Ablation controller. Device must also be at least 6mm in diameter to reduce the need for cervical dilation. Fluent Management System must be a dual peristaltic pump with integrated suction, deficit accuracy within =/- 50 ml, live deficit monitoring per AAGL and ARN guidelines, include system warnings for deficit, supply, and waste bags. Able to hang a bag while system is running. Deficit set from 100ml- 2500ml in 50 ml increments and be able to have pressure set from 40-120mmhg in 5mmhg increments. Touch Screen. Location to connect the Myosure hysteroscopes. Include equipotential plug, connector used to electrically bone the system to another conductive material or ground the system to a safety ground. Have wheels, wheel locks and handle to enable, prevent and relocate the system. Include visual and audible alerts. Hysteroscope and Omni scope must be compatible with the Fluid Management System and be preset in the Fluid Management System. Training and support provided at no additional cost. Include standard one (1) year warranty to include repair and replacement. Offer 3 Year extended warranty Deliverables: all accessories listed in the quote to support the equipment/devices to include the 3-year extended warranty requested specifically by NMVA Chief of Biomed Engineering to ensure constant care of devices that will be used frequently by multiple surgeons. One full year warranty coverage and unit is fully covered by Hologic (Including repair/replacement). Biomed will require usage of expendables to verify calibrations/PMs. Due to OR electrical Amperage issues in the past, usage of the equipment in specific ORs will need to be reviewed for utilization and setup prior to use. End user responsible for routine cleaning. Additional resources for review of the e equipment: https://gynsurgicalsolutions.com/resource/ End user responsible for cleaning device Performance Monitoring: upon delivery Security Requirements: This contract will not require access to VA sensitive information. Vendor personnel will not perform any functions requiring access to a VA system or VA sensitive information (e.g., system administrator privileged access to a VA system, or contractor systems or processes that utilize VA sensitive information). Any security violations or attempted violations shall be reported to the COR immediately upon detection. The contractor shall adhere to applicable VA policies and procedures governing information security, especially those that pertain to certification and accreditation. The C&A requirements do not apply, and that a Security Accreditation Package is not required Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI). N/A Other Pertinent Information or Special Considerations. Identification of Possible Follow-on Work. The Raymond G. Murphy VA Health Care Center is a full-service facility and the Surgical Service GYN Providers requests the Hologic Fluent system for use in the operating room for procedures necessary to provide specialized Veteran patient care. Identification of Potential Conflicts of Interest (COI). N/A Identification of Non-Disclosure Requirements. N/A Packaging, Packing and Shipping Instructions. The Raymond G. Murphy VA Health Care Center Surgical Services. 1501 San Pedro Dr. SE, Albuquerque, NM, 87108. Inspection and Acceptance Criteria. All packaging will be inspected for sterility, outdates and correctness of items. Risk Control: All items should be free of defects and sterility uncompromised, delivered together. Place of Performance. The Raymond G. Murphy VA Health Care Center Surgical Services. 1501 San Pedro Dr. SE, Albuquerque, NM, 87108. Period of Performance: N/A Delivery Schedule. 30 Days ARO. All items should be free of defects and sterility uncompromised, delivered together. Delivery shall be provided no later than 30 days after receipt of order (ARO). FOB Destination. Place of Performance/Place of Delivery Address: Department of Veterans Affairs New Mexico VA Health Care System 1501 San Pedro Drive, SE Albuquerque, NM Postal Code: 87108 Country: UNITED STATES The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html. The following solicitation provisions apply to this acquisition: FAR 52.212-1, Instructions to Offerors Commercial Items [June 2020] Please see Attachment A Clauses and Provisions for addenda information pertaining to FAR 52.2121-1. FAR 52.212-3, Offerors Representations and Certifications Commercial Items [Feb 2021] Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Items. If paragraph (j) of the provision is applicable, a written submission is required. The following contract clauses apply to this acquisition: FAR 52.212-4, Contract Terms and Conditions Commercial Items [[OCT 2018] Please see Attachment A Clauses and Provisions for addenda information pertaining to FAR 52.212-4 FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders [JAN 2021] The following subparagraphs of FAR 52.212-5 are applicable: All quoters shall submit their quotes along with their authorized distribution letter from the manufacturer to verify they are an authorized distributor of the products provided. Any quotes received without an authorized distribution letter will be considered non-responsive. All quotes shall be sent to the timothy.garrity@va.gov. Award will be based upon price only comparison of quotes in accordance with the Simplified Acquisition Procedures of FAR 13. The award will be made to the response most advantageous to the Government. Responses should contain your best terms and conditions. To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows: ""The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."" OR ""The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"" Quoters shall list exception(s) and rationale for the exception(s), if any. Submission of quotes shall be received not later than 11AM PST on April 14, 2021. Please submit all quotes via email to timothy.garrity@va.gov. No other means of communication will be accepted. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Point of Contact listed below. Point of Contact Tim Garrity timothy.garrity@va.gov.
 
Web Link
SAM.gov Permalink
(https://beta.sam.gov/opp/975b2302bd234a4b92cdeec70fbe5e13/view)
 
Place of Performance
Address: Department of Veterans Affairs New Mexico VA Healthcare System Surgical Service 1501 San Pedro Drive, SE, Albuquerque, NM 87108, USA
Zip Code: 87108
Country: USA
 
Record
SN05965399-F 20210409/210407230117 (samdaily.us)
 
Source
SAM.gov Link to This Notice
(may not be valid after Archive Date)

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