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 contact@example.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 contact@example.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.