6525--Endoscopes

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6 -- Streamlined Procedures for Evaluation and Solicitation for Commercial Items, in conjunction with FAR Subpart 13.5 -- Simplified Procedures for Certain Commercial Products and Commercial Services, and supplemented with additional information included in this notice.

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6 -- Streamlined Procedures for Evaluation and Solicitation for Commercial Items, in conjunction with FAR Subpart 13.5 -- Simplified Procedures for Certain Commercial Products and Commercial Services. This announcement constitutes the only solicitation; offers are being requested and a written solicitation is attached to this announcement.

This solicitation document and incorporated provisions and clauses are those in effect through the Federal Acquisition Circular (FAC) 2023-04, dated June 2, 2022.

Solicitation # 36C26223Q1177 is issued as a Request for Quote (RFQ) and constitutes the only solicitation. The Government intends to award a single Firm-Fixed Price (FFP) award.

This procurement will be issued as a 100% SDVOSB set-aside solicitation.

The Government is seeking a contract to acquire endoscopes, surgical hand tools, and an on-call, full-time technician for the VA Greater Los Angeles Healthcare System. This solicitation is being procured as a brand name or equal IAW 52.211-6 -- Brand Name or Equal. The submissions must meet the following salient characteristics:

LEASE EQUIPMENT SPECIFICATIONS: The following equipment shall be made available for lease:

Digital Capture Device

Must be able to connect and control camera, light source, arthroscopic shaver, arthroscopic RF (radio frequency), and arthroscopic pump

Must be able to control interface through camera head in the surgical field (e.g., surgeon can control connected clinical devices directly from the camera head)

Must be able to display critical device status onto surgical monitors [i.e., connects to each clinical device (arthroscopic shaver, pump, RF generator, light source, camera), and displays critical device status on the surgical monitor being used in the sterile field]

Must have device status display options (e.g., pump and insufflation preset pressure, pump and insufflation actual pressure, camera and light source light levels, arthroscopic shaver RPM s, arthroscopic shaver resection mode, digital capture disc usage and recording formats)

Must be able to customize printing, saving, and clinical device setup/control for each surgeon with user profiles

Must have the integrated surgical timeout feature that includes being pre-loaded with standard surgical timeout requirements, customizable per facility, displays surgical timeout questions on all monitors displayed

Must enable electronic documentation of surgical timeout feature, full staff participation, and save to the patient s electronic file

Must store surgeon profile settings that include, but are not limited to, the following: clinical device preferences, arthroscopic shaver RPMs, arthroscopic pump critical pressure settings, surgical display color preference settings, camera system color/light preference settings, and light source power intensity settings

Surgical Camera

Must be high-definition video with 1920x1080p in its native resolution

Must include, at minimum, CMOS 3-chip camera technology designed for enhanced light sensitivity and for increased patient safety

Camera must have integrated device control from the camera head

Must have at least 4 programmable buttons on the camera head to control pictures, video, and light source

Must have at least four camera head configurations that include, but are not limited to, standard (45 degrees), inline, urology, and integrated

Must have integrated enhancement for improved image brightness

Must have integrated desaturation to desaturate red coloration in particularly red cases

Must be able to control ICG (indocyanine green) viewing from the camera head buttons including backlighting and ICG laser adjustments

Must have programmable color settings and button function settings per surgical specialty

Must have 18mm stainless steel coupler with single-handed focusing design

Must include at least 5 surgical specialties settings that include, but are not limited to, the following: Orthopedics, ENT, General Surgery, Urology, and Colorectal

Settings must provide optimized performance to address the specific color and lighting needs of individual surgical procedures

Surgical Video Display

Surgical monitor must be, at minimum, a 26 display with a LED back light

Monitor must have a 16:9 aspect ratio

Monitor must have 1920x1080 native resolution

Monitor must have preset specialty settings (General Surgery, Colorectal, etc.)

Must have an on-screen user interface with shortcut keys

Must include custom gamma curves

Must have an integrated protective screen layer with 3H hardness

Must have double-sided anti-reflective coating

Must have built-in handles to aid in monitor

Must have the following inputs: DVI, VGA, HD/SD-SDI, C-Video, S-Video Component

Must have the capability of Picture-in-Picture, Picture-by-Picture, and Picture-on-Picture

4K (or greater) Surgical Display

Surgical monitor must have, at minimum, 4X the resolution of a 1080p image

Monitor must have, at minimum, 4K pixel density for accurate and clear images

Must weight no more than 23.1 lbs. allowing staff to install in both integrated and cart-based rooms

Must include multiple input options for use with a variety of visualization equipment

Light Source

Must be able to control the light source directly from the camera head

Must enable users to visualize white light, infrared light, and indocyanine green (ICG)

Must have integrated infrared lighted fibers and integrated indocyanine green ICG fluorescence capability

Must have adjustable light intensity

Must have a LED touch-screen user interface

Must provide real-time endoscopic visibility and near-infrared fluorescence imaging

Must enable surgeons to perform minimally invasive surgery using standard endoscopic visible light

Must provide enhanced visual assessment of vessels, blood flow and related tissue perfusion, in addition to bile duct visualization with the use of near-infrared imaging

Insufflator

Must have surgical specialty operating modes that include, but are not limited to: General surgery, colorectal, ENT, Ortho, etc.

Each operating mode must utilize pressure settings and flow rates designed to maintain stable pneumoperitoneum

Must have integrated smoke evacuation to provide consistently clear images through an inflow and outflow management system to maintain stability while actively evacuating smoke

Must include four controlled levels of smoke evacuation that filter out 99.999% of all particles greater than 0.1 micrometer to help protect patients and staff from the harmful carcinogens found in surgical plume

Must have integrated heating and humidification (i.e., gas heating allows CO2 to warm to core body temperature before entering the patient and minimizes laparoscope fogging)

Must have the ability to control connected devices, including the insufflator, from the sterile field using the camera head, remote control, touch panel, and voice control headset. This includes control over insufflator flow rates, pressure settings, and smoke evacuation levels.

Must include de-sufflation

Printer

Must be a medical-grade color printer

Must have dye-sublimated thermal printing

Must have self-laminating media

Must have, at minimum, 8-bit processing gradations

Must include A4 and Letter size printing options

Arthroscopic Resection System

Must be able to combine RF (radio frequency) and shaver control in one complete console

Must be able to customize settings for handpieces, footswitch, RF probes, and shaver

Must be able to access constant voltage coagulation

Operating Room Surgical Light

Must have 360-degree light head rotation for maneuverability

Must have 102 LEDs in a non-array based configuration

Must have at least the 4 built-in color options settings that include, but are not limited to the following: 3600, 4000, 5000 and 5500k

Must have a built-in laparoscopic guide light feature

Must have a built-in wireless camera

Must have an optimum laminar flow compliance with a rating of SWKI Class 5

Must have an Ingress Protection (IP) from dust & water with a classification of IP 53

May include optional features, such as integrated ambient light and green or white light for ambient laparoscopic lighting

May include an interactive touch panel

Surgical lens material must be made of surgical-grade medical glass

Evacuation Chair

Must be intended for emergency evacuation

Must be able to hold at least 500 pounds going downstairs and be lifted up the stairs (with lighter patients) if necessary

Must have tracks able to descend stairs and resist acceleration while under full capacity

Must have handles behind patient and extendable handles at patient s feet to allow 2 or more people to help with evacuation

Must have safety straps to hold patient in the chair

Must keep patients in safe sitting position when rolling on a flat floor or when descending stairs

Must come with a cover

Must be able to hang on a wall during storage

Must come with feet support

Feet support material must be able to withstand cleaning and decontamination

Corded Small Bone/Podiatry Hand Piece

Must have a dedicated wire driver for small bone orthopedic procedures

System must have hand switch and foot pedal operation

Must require no tools to load burs or blades

Must be compatible with the console instrument driver provided as part of the lease

Must have a removable hand switch to allow the same hand piece to be used for multiple functions

Console must be capable of operating two hand pieces at one time

Sagittal saw must feature a rotating, indexing head to increase blade position versatility when cutting

Cordless Small Bone Power Tool

Must have a modular small bone power system with a pencil grip and a pistol grip available

Must include the following modular motors: sagittal saw, oscillating saw, reciprocating saw, micro drill, and universal driver

Battery modules must have a 30-day shelf life without losing power or performance

Battery must be insulated to increase resistance thermal damage from sterilization

Must include a light to indicate battery status

Must be compatible with resurfacing tool burs

Large Bone Power Tool

Batteries must have a 30-day shelf life after charging with no loss of performance

Battery charger must track hand piece performance

Rotary hand piece must offer 157 in/lbs. of torque

Rotary hand piece must have a drilling and reaming switch

Sagittal saw must offer 12,000 cpm in fast mode and 10,000 cpm in standard mode

Reciprocating saw must allow for two cut speeds: up to 14,000 cpm in fast mode and up to 11,000 cpm in standard mode

Cordless driver must offer a reaming attachment

Hand pieces must weigh less than 2.5 lbs

Must offer dedicated hand pieces for sagittal saw, rotary drill, reciprocating saw, sabo saw, and cordless driver to decrease OR staff time spend changing drilling/cutting components

Hand pieces must be fully submersible for liquid prevention from normal use

Waste Management

System must be continually closed

Must utilize drip reduction manifolds with a backflow prevention valve

Touchscreen display must be at least 8.4 with an additional display of at least 7

Must include a powered IV

Must include internal rotating power washers for system cleaning

Must include an integrated smoke evacuator

Must have an automated cleaning cycle that does not require additional or staff operation

Smoke evacuation filter must have up to 80 hours of smoke evacuation independent of fluid suction time

Instrument Driving Console

Must be able to power small bone power tools and high-speed drills

Must be compatible with the power tools and high-speed drills provided as part of the lease

Must be able to create, store, and transfer at least 100 user profiles

Must have adjustable acceleration and braking

Must have software that can adjust torque, tactile feel, and drill precision/performance

Must have an adjustable irrigation flow rate

Must have at least three foot-pedal choices that include, but are not limited to, the following: raise, lower, and expand

Must have at least three hand piece ports

Must be able to run at least 2 heavy duty handpieces simultaneously

Must have colored illumination to match drills and foot pedals

Must have distinct, different audio tones to denote different actions and alerts

High Speed Drills

Drill must be compatible with the instrument driver provided as part of the lease

Motor construction must utilize flat wiring and triangular shaped magnets to reduce size and increase run time while remaining cool

Must spin at least 75,000 rpm

Must have at least 5.5 in/lbs. of stall torque

Must be less than .7 inches in diameter

Must weigh less than .673 lbs. including hose

Must include an integrated irrigation attachment

Nerve Monitor

Must have ability to be used in ENT, neurosurgery, and general surgery

Laryngeal electrodes must work with any non-silicone ET tube

Nerve activity review must be available during procedure and stored within device for later review

Must stimulate and map cranial, peripheral motor, and mixed motor sensory nerves

Must test muscle action potential to measure constancy of function before, during, and after surgery

Must have an algorithm to distinguish between artifact and true nerve stimulation

BiPolar Generator

Must have a color screen to allow for adjustments

Must utilize aperiodic waveform to reduce or eliminate popping during surgery

Must offer both cut and coagulation functions

Ultrasonic Aspirator

Must redirect the longitudinal stroke into a longitudinal and torsional motion to create a non-rotational and highly directional motion providing the surgeon with the ability to safely dissect bone in close proximity with delicate structures

Must be compatible with a tip consisting of two V-shaped notches opposite one another which enables fine, sharp dissection of target tissue

Must have a universal handpiece that can operate all tips used with the system

Handpiece must not require external cooling by piezoelectric transducer

Console must have included irrigation

System must use one, dual-bore tubing kit for irrigation and suction

Suction, irrigation, and ultrasonic functions must be able to be used alone or simultaneously

Radiofrequency Generator

Must be able to output no less than 100 watts

Must be able to create a strip lesion without removing electrodes

Must be able to choose the order of lesions

Must track number of uses for each electrode

Electrode must be compatible cannulas which form a V-shape to target large lesion zones

Electrode must be compatible with cannulas which have a side port to allow for improved anesthesia propagation local to the target lesion zone

Electrode must be compatible with cannulas which have the ability for monopolar and parallel bipolar lesions

Electrode must be compatible with 20-gauge cannulas

Micro-debrider Hand Piece

Must have at least 5,000 rpm in oscillation

Must have straight through suction

Must have a flush feature to allow the surgeon to manually unclog hand piece using its own irrigation

Bone Mill

Must be compatible with multiple blade sizes

Must have preassembled blades

Must have a single pass cutting action

Must be compatible with the instrument driving console provided as part of the lease

Other medical requirements as directed by the Government

Must be able to provide surgical scopes (e.g., cystoscopes, laparoscopes, arthroscopes)

Must be able to provide manual instruments (e.g., graspers, scissors, obturators) to help with minimally invasive surgery as required by a surgeon

Must provide a micro-cart that meets the minimum of hospital requirements

Must provide a desktop stand capable of being used in a surgical environment

The information identified above is intended to be descriptive, not restrictive and to indicate the quality and services that will be satisfactory. It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the services that fulfill the required specifications. If a solicitation is published, a site walk through may be available to address key details.

See attached SF 1449 Solicitation for Statement of work (SOW), applicable clauses / provisions, and other pertinent information relative to this solicitation.

Place of Performance: VA Greater Los Angeles Healthcare System

11301 Wilshire Blvd.

Los Angeles, CA 90073

Period of Performance: Within 90 days of placing order.

Provisions 52.212-1, Instructions to Offerors Commercial and 52.212-2, Evaluation Commercial Items are applicable to this acquisition. Furthermore, Provision 52.212-2 is utilizing the Lowest Price Technically Acceptable (LPTA) on an Acceptable/Unacceptable evaluation process.

Submitting Quote: Offeror(s) shall submit their quote on company letterhead and shall include the completed pricing forms, along with name, address, telephone number of the offeror, firm s SAM Unique Entity ID, total price and a completed copy of FAR Clause 52.212-3 Offerors Representations and Certifications - Commercial Items or a copy of offeror s annual offeror representations and certifications (ORCA) document from www.sam.gov as required by FAR Clause 52.212-3 Offerors Representations and Certifications - Commercial Items. As an alternative, Offeror(s) may use the Price/Cost Schedule of the attached SF 1449 for quote submission.

Submit all question(s) to Bridgett Sharma at Bridgett.Sharma@VA.gov no later than July 20, 2023, 4:00 PM Pacific Standard Time (PST). Ensure to reference solicitation # 36C26223Q1177 within subject line of the email.

Quotes must be received by July 27, 2023, by 4:00 PM PST. Email your quote to Bridgett Sharma at Bridgett.Sharma@VA.gov. Ensure to reference solicitation # 36C26223Q1177 within subject line of the email. Quote(s)/offer(s) received after the prescribed deadline, shall be considered non-responsive and will not be considered for award.

CLAUSES AND PROVISIONS

For Clauses and Provisions required, see the attached SF 1449.