36C10G23Q0029.docx

Combined Synopsis/Solicitation Notice Combined Synopsis/Solicitation Notice

SUBJECT* NX EQ Pulse Oximeters

GENERAL INFORMATION

USA

OPAL | Strategic Acquisition Center

10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

POINT OF CONTACT*

Contract Specialist

KEVER L. SWAFFORD

kever.swafford@va.gov

PLACE OF PERFORMANCE

ADDRESS

Nationwide

POSTAL CODE

COUNTRY

US

ADDITIONAL INFORMATION

AGENCY’S URL https://www.va.gov/opal/sac/index.asp

*= Required Field Combined Synopsis/Solicitation Notice

DESCRIPTION

Solicitation Number:

36C10G23Q0029

Notice Type:

Combined Synopsis/Solicitation

Synopsis:

COMBINED SYNOPSIS/SOLICITATION

This is a combined synopsis/solicitation for brand name or equal 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 will not be issued.

Solicitation number 36C10G23Q0029 is issued for this combined synopsis/solicitation; this solicitation is being issued as a Request for Quote (RFQ).

This combined synopsis/solicitation incorporates provisions and clauses in effect through Federal Acquisition Regulation; Federal Acquisition Circular (FAC) FAC 2023-05, 09/07/2023.

Requirement Description:

VA has a requirement to purchase Nonin® Pulse Oximeters or Equal, noninvasive monitor and related equipment and accessories to deliver patient care at its VA Medical Centers around the country. Pulse oximeters noninvasively monitor SpO₂ (generally expressed as a percentage [e.g., 70% to 100%]) of arterial hemoglobin by measuring light-absorbance changes resulting from arterial blood flow pulsations. Their use allows continuous and instantaneous monitoring of oxygenation and pulse rate, can provide early detection of hypoxia before other signs such as cyanosis are observed, and may reduce the frequency of arterial puncture and laboratory blood gas analysis. Hypoxia is possible if hypoxic gas mixtures are inadvertently administered during general anesthesia, if gas lines are occluded during surgery, if oxygen delivery is discontinued postoperatively during transport to the recovery room, or if a procedure or disease (e.g., spinal anesthesia, bronchoscopy, acute bronchospasm) blocks the air passages or hinders the breathing process. Prolonged hypoxia can result in irreversible brain damage, organ damage, or death. Pulse oximetry can detect decreasing oxygen saturation levels before damage occurs and, generally, before the appearance of physical signs. Pulse oximetry is considered a standard of care for monitoring arterial oxygen saturation in the operating room during procedures requiring anesthesia and in intensive care units and recovery. It is also frequently used in burn units, cardiac catheterization laboratories, and ambulances. It is also used in general medical/surgical and outpatient areas for spot-checking. Other applications include dentistry anesthesia, sleep studies, exercise testing, and home monitoring of certain patients, such as infants at risk for sudden infant death syndrome and patients requiring respiratory therapy. Battery-powered units are particularly convenient because they can also monitor the patient during transport.

A single award Requirements contract will be awarded IAW FAR 52.211-6 Brand Name or Equal in accordance with all terms, conditions, provisions, specifications, and schedule of this solicitation herein. Quotes shall contain the terms for cost/price and technical capabilities of the brand name or equal equipment. The Government reserves the right to award without discussions.

The associated North American Industrial Classification System (NAICS) code for this procurement is 339112 – Surgical and Medical Instrument Manufacturing: 6515 – Medical and Surgical Instruments, Equipment, and Supplies and the associated size standard is 1,000 employees. This procurement action is issued as full and open.

This acquisition is for a single award Requirements contract in accordance with FAR Part 16.5 for Nonin® brand name or equal Pulse Oximeters noninvasively monitor, and related equipment and accessories as identified in ATTACHMENT A – NX EQ Pulse Oximeters – PRICE COST SCHEDULE. All interested companies shall provide a quote for all Contract Line Item Numbers (CLINs) listed in ATTACHMENT A – NX EQ Pulse Oximeters – PRICE COST SCHEDULE.

The ordering period is for one 12-month base year with four 12-month option years. Delivery is FOB destination. Firm-Fixed Price Orders will be placed against this contract in writing and will provide the delivery locations, delivery dates and exact quantities.

The FAR provision at 52.212-1, Instructions to Offerors – Commercial, applies to this acquisition including attached addenda to the provision.

The FAR provision at 52.212-2, Evaluation -- Commercial Items, and the specific evaluation criteria as attached addenda also applies to this acquisition.

The Offeror is to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Items, with its offer.

Clause at 52.212-4, Contract Terms and Conditions -- Commercial Items, applies to this acquisition and a statement regarding any addenda to the clause. Addendum is attached.

Clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items, applies to this acquisition and a statement regarding which, if any, of the additional FAR clauses cited in the clause are applicable to the acquisition. Addendum is attached.

All interested quoters must be registered in the System for Award Management (SAM) prior to submitting a quote. You may access SAM at https://sam.gov/SAM/.

Questions regarding this combined synopsis/solicitation are due via email by 11:59PM EST on November 10, 2023, to Contract Specialist, Kever L. Swafford, Kever.Swafford@va.gov and Contracting Officer, Sara Vickroy at Sara.Vickroy@va.gov. No calls will be accepted.

Quotes are due via email by 11:59PM EST on November 20, 2023, to Contract Specialist, Kever L. Swafford at Kever.Swafford@va.gov and Contracting Officer, Sara Vickroy at Sara.Vickroy@va.gov.

PRODUCT DESCRIPTION

1. SCOPE OF WORK:

The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the Pulse Oximeter product line as a candidate for a VA-wide (otherwise referred to as “national”) single Requirements contract award.

Pulse oximeters noninvasively monitor SpO₂ (generally expressed as a percentage [e.g., 70% to 100%]) of arterial hemoglobin by measuring light-absorbance changes resulting from arterial blood flow pulsations. Their use allows continuous and instantaneous monitoring of oxygenation and pulse rate, can provide early detection of hypoxia before other signs such as cyanosis are observed, and may reduce the frequency of arterial puncture and laboratory blood gas analysis. Hypoxia is possible if hypoxic gas mixtures are inadvertently administered during general anesthesia, if gas lines are occluded during surgery, if oxygen delivery is discontinued postoperatively during transport to the recovery room, or if a procedure or disease (e.g., spinal anesthesia, bronchoscopy, acute bronchospasm) blocks the air passages or hinders the breathing process. Prolonged hypoxia can result in irreversible brain damage, organ damage, or death. Pulse oximetry can detect decreasing oxygen saturation levels before damage occurs and, generally, before the appearance of physical signs. Pulse oximetry is considered a standard of care for monitoring arterial oxygen saturation in the operating room during procedures requiring anesthesia and in intensive care units and recovery. It is also frequently used in burn units, cardiac catheterization laboratories, and ambulances. It is also used in general medical/surgical and outpatient areas for spot-checking. Other applications include dentistry anesthesia, sleep studies, exercise testing, and home monitoring of certain patients, such as infants at risk for sudden infant death syndrome and patients requiring respiratory therapy. Battery-powered units are particularly convenient because they can also monitor the patient during transport. The FDA has provided a safety communication pertaining to all pulse oximeters: Pulse Oximeter Accuracy and Limitations: FDA Safety Communication | FDA.

The Contractor must demonstrate the ability to meet all requirements for the solicitation. The objective is to provide Pulse Oximeters to be used by clinicians throughout the VA medical centers and facilities. The period of performance is for a base of 12-months with four 12-month option periods.

2. REQUIREMENT

This requirement will be IAW FAR clause 52.211-6, “Brand Name or Equal” which requires the offeror indicate that each product being offered as an “equal” product to the Nonin® Pulse Oximeters. For each equal product, the offeror must include a description reflecting the salient characteristics (SC) and level of quality that will satisfy the salient physical, functional, or performance characteristics of the equal product(s) specified in the solicitation. The offeror must also clearly identify the item by brand name (if any) and make/model number. Finally, the offeror must include descriptive literature, such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer, and clearly describe any modifications it plans to make to a product to make it conform to the solicitation requirements.

Contract Line Item#

WristOx2®, Model 3150 Wrist Worn Pulse Oximeter delivers highly accurate readings in the widest range of patient populations and settings. From the hospital to the home, the WristOx2®, Model 3150 is ideal for applications including cardio-ambulatory monitoring, remote wireless monitoring and overnight studies. Features advanced performance and reporting capabilities including enhanced connectivity and increased memory storage. Includes: Model 3150 WristOx2 Pulse Oximeter, 2 AAA Alkaline Batteries, 1 Wrist Band, Model 8000SM-WO2 soft sensor and Operator's Manual on CD-ROM, USB driver software (on operators manual CD).

Onyx Vantage 9590 Finger Pulse Oximeter.

Clinician-facing, easy-to-read, bright LED, Threecolor pulse quality indicator LED, Accuracy in the widest range of patients and conditions, One product for pediatric to adult patients, Proven

Contract Line Item#

durability, Automatic turn on and off, Portable. COLOR: Black.

Complete with Lanyard, instructions on CD and two AAA batteries.

Onyx Vantage 9590 Finger Pulse Oximeter.

Clinician-facing, easy-to-read, bright LED, Threecolor pulse quality indicator LED, Accuracy in the widest range of patients and conditions, One product for pediatric to adult patients, Proven durability, Automatic turn on and off, Portable. COLOR: Blue.

Complete with Lanyard, instructions on CD and two AAA batteries.

Clinician-facing, easy-to-read, bright LED, Threecolor pulse quality indicator LED, Accuracy in the widest range of patients and conditions, One product for pediatric to adult patients, Proven durability, Automatic turn on and off, Portable. COLOR: Red.

Complete with Lanyard, instructions on CD and two AAA batteries.

Includes: 1 7500 Pulse Oximeter, 1 8000AA-3 Finger Clip SpO2 Sensor, 1 Power Supply, 1 Power Cord-US, 1 7500B Battery Pack, and one

(1) 7500B Operators Manual on CD-ROM)

The Department of Veterans Affairs (VA) is seeking vendors who can provide Nonin® Pulse Oximeters or equal as listed above which meet all the following salient characteristics. Vendors may quote any product solution or configuration so long as they meet the salient characteristics. Products quoted in the technical volume must be captured on the Vendor’s pricing volume (Attachment A - Price Cost Schedule) of the solicitation. Vendors may quote any additional ancillary products which they deem to be essential to the functionality of the proposed solution; these items must be captured in the Vendor’s pricing volume with a quantity of zero.

CLIN 0001 (WristOx2®, Model 3150, Wrist Worn Pulse Oximeter) applies to the following SC’s:

FOUND IN TECHNICAL LITERATURE

CLIN 0002-0004 (Onyx Vantage 9590 Finger Pulse Oximeter) applies to the following SC’s:

FOUND IN TECHNICAL LITERATURE

FOUND IN TECHNICAL LITERATURE

in all lighting conditions, day or night

of pulse quality Literature Review

of 70-100% Literature Review

CLIN 0005 (7500 Series Tabletop Pulse Oximeter) applies to the following SC’s:

FOUND IN TECHNICAL LITERATURE

FOUND IN TECHNICAL LITERATURE

a sensor has become disconnected Literature Review

Vendors may quote any product solution or configuration so long as they meet the salient characteristics. Products quoted in the technical volume must be captured on the Vendor’s pricing volume (Attachment A - Price Cost Schedule) of the solicitation. Vendors may quote any additional ancillary products which they deem to be essential to the functionality of the proposed solution; these items must be captured in the Vendor’s pricing volume with a quantity of zero.

The following attachments are incorporated by reference. All criteria outlined in the attachments are applicable to this combined synopsis/solicitation.

See attached document: ATTACHMENT A - NX EQ PULSE OXIMETERS - PRICE COST SCHEDULE.

See attached document: ATTACHMENT B- CONTRACT ADMINISTRATION - NX EQ PULSE OXIMETERS -.

See attached document: ATTACHMENT C- CONTRACT CLAUSES - NX EQ PULSE OXIMETERS.

See attached document: ATTACHMENT D - SOLICITATION PROVISIONS - NX EQ PULSE OXIMETERS.

See attached document: ATTACHMENT E - REPORTING TOOL - NX EQ Pulse Oximeters.

Combined Synopsis/Solicitation Notice