6515--NX EQ Auditory Function Screening Device

The purpose of this Amendment is to extend the closing date of the solicitation to January 21, 2022 at 11:59PM EST.

Solicitation Number:

36C10G22Q0016

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 36C10G22Q0016 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 Circular (FAC) 2021-07, dated 10 September 2021.

Requirement Description:

VA has a requirement to purchase Auditory Function Screening Devices to deliver patient care at its VA Medical Centers around the country. Auditory Function Screening Devices are used for evaluating hearing acuity. Auditory Function Screening Devices usually consist of an embedded hardware unit connected to a pair of headphones and a test subject feedback button, sometimes controlled by a standard PC. There are five different Auditory Function Screening Devices, and these devices are targeted at specific evaluations. A Mid-level Audiometer, a Middle Ear Analyzer, a Two Channel Clinical Audiometer, a Otoacoustic Emissions, an Evoked Potential Screener, and a Pure Tone & Tympanometry Screener.

A single award Requirements contract will be awarded for the purchase of brand name or equal equipment 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 band 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, Product Service Code: 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 competition.

This acquisition is for a single award Requirements contract in accordance with FAR Part 16.5 for Grason-Stadler GSI brand name or equal Auditory Function Screening Devices and related equipment and accessories as identified in ATTACHMENT A NX EQ AUDITORY FUNCTION SCREENING DEVICES PRICE COST SCHEDULE. All interested companies shall provide a quote for all Contract Line Item Numbers (CLINs) listed in ATTACHMENT A NX EQ AUDITORY FUNCTION SCREENING DEVICES PRICE COST SCHEDULE.

The ordering period is for one 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

December 27, 2021 to Contract Specialist, Ninatile Bacote at Ninatile.Bacote@va.gov and Contracting Officer, David Barber at David.Barber@va.gov. No calls will be accepted.

Quotes are due via email by 11:59PM EST on January 13, 2022 to Contract Specialist, Ninatile Bacote at Ninatile.Bacote@va.gov and Contracting Officer, David Barber at David.Barber@va.gov.

1. SCOPE OF WORK:

The Veterans Health Administration (VHA) Equipment Life Cycle Management (ELCM) Program identified has identified the Auditory Function Screening Device product line as a candidate for a VA-wide (otherwise referred to as national ) single Requirements contract.

Auditory Function Screening Device are used for evaluating hearing acuity. Auditory Function Screening Devices usually consist of an embedded hardware unit connected to a pair of headphones and a test subject feedback button, sometimes controlled by a standard PC. There are five different Auditory Function Screening Devices, and these devices are targeted at specific evaluations. A Mid-level Audiometer, a Middle Ear Analyzer, a Two Channel Clinical Audiometer, a Otoacoustic Emissions, an Evoked Potential Screener, and a Pure Tone & Tympanometry Screener.

The Auditory Function Screening Device required for this program have been identified as most advantageous to the Government to be incorporated into a national Requirements contract. The salient characteristics (SC) for these commercial items are identified in the Auditory Function Screening Device Product Description.

The Contractor must demonstrate the ability to meet all requirements for the solicitation. The objective is to provide Auditory Function Screening Device to be used by clinicians throughout the VA medical centers and facilities. The period of performance is for one 12-month base period 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 quoter indicate that each product being offered as an equal product to the Grason-Stadler GSI® brand name Auditory Function Screening Device. 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 quoter must also clearly identify the item by brand name (if any) and make/model number. Finally, the quoter 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.

CLINS

MFG

P/N

DESCRIPTION

0001

Grason-Stadler

GSI 39

The GSI 39 Auto Tympanometry provides a flexible, screening product for tympanometry, acoustic reflex measurements and audiometry to meet testing needs today and in the future. The product is available in five different versions to meet the unique demands of each facility. All five versions are fast, versatile and easy to use. It is possible to add additional modalities such as audiometry, contralateral reflexes or 1,000 Hz probe tone as the facility testing requirements expand.

0001-01

Grason-Stadler

8514899

GSI 39 Auto Tymp - Version 1 - 226 Hz Tymp & Ipsi Reflex

0001-02

Grason-Stadler

8514900

GSI 39 Auto Tymp - Version 1 226 Hz + 1 kHz Tymp & Ipsi Reflex

0001-03

Grason-Stadler

8514901

GSI 39 Auto Tymp - Version 2 - 226 Hz Tymp with Ipsi Reflex & Contra Reflex

0001-04

Grason-Stadler

8514902

GSI 39 Auto Tymp - Version 2 - 226 Hz + 1 kHz Tymp with Ipsi Reflex & Contra Reflex

0001-05

Grason-Stadler

8514903

GSI 39 Auto Tymp - Version 3 - 226 Hz Tymp with Ipsi & Contra Reflex & Pure Tone Audiometry

0001-06

Grason-Stadler

8514904

GSI 39 Auto Tymp - Version 3 - 226 Hz + 1 kHz Tymp with Ipsi & Contra Reflex & Pure Tone Audiometry

0001-07

Grason-Stadler

8514905

GSI 39 Auto Tymp -Version 4 - 226 Hz Tymp with Ipsi Reflex & Pure Tone Audiometry

0001-08

Grason-Stadler

8514906

GSI 39 Auto Tymp - Version 4 - 226 Hz + 1 kHz Tymp with Ipsi & Pure Tone Audiometry

0001-09

Grason-Stadler

8514907

GSI 39 Auto Tymp - Version 5 - 226 Hz Tymp Only

0001-10

Grason-Stadler

8514908

GSI 39 Auto Tymp - Version 5 - 226 Hz + 1 kHz Tymp Only

0002

Grason-Stadler

GSI 39

Upgrade Options

0002-01

Grason-Stadler

8020194

GSI 39 From 226Hz to 226 Hz+1000 probe

0002-02

Grason-Stadler

8020195

GSI 39: 226Hz Version 1 to 226 Hz Version 2

0002-03

Grason-Stadler

8020196

GSI 39: 226Hz Version 1 to 226 Hz Version 3

0002-04

Grason-Stadler

8020197

GSI 39: 226Hz Version 1 to 226 Hz Version 4

0002-05

Grason-Stadler

8020198

GSI 39: 226Hz Version 2 to 226 Hz Version 3

0002-06

Grason-Stadler

8020199

GSI 39: 226Hz Version 4 to 226 Hz Version 3

0002-07

Grason-Stadler

8020200

GSI 39: 226Hz Version 5 to 226 Hz Version 1

0002-08

Grason-Stadler

8020201

GSI 39: 226Hz Version 5 to 226 Hz Version 2

0002-09

Grason-Stadler

8020202

GSI 39: 226Hz Version 5 to 226 Hz Version 3

0002-10

Grason-Stadler

8020203

GSI 39: 226Hz Version 5 to 226 Hz Version 4

0003

Grason-Stadler

GSI AudioStar Pro

GSI AudioStar Pro is a versatile two-channel clinical audiometer designed to perform efficient audiometric evaluations on every patient population. It may be used independently or with a computer for HIPAA compliant data storage and EMR/EHR compatibility.

0003-01

Grason-Stadler

8518227

AudioStar Pro with DD45, B81, IP30 and DD450 Transducers with GSI-AMTAS Automated Audiometry. (Does Not Include Computer.)

0003-02

Grason-Stadler

8518226

AudioStar Pro with DD45, B81, IP30 and DD450 High Frequency Headphones

0003-03

Grason-Stadler

8515319

AudioStar Pro with DD45, B81 and IP30 Insert Earphones

0004

Grason-Stadler

GSI AudioStar Pro

GSI AudioStar Pro Options

0004-01

Grason-Stadler

8102475

Basic Speaker Kit with cable, 90 dB HL

0004-02

Grason-Stadler

8013647

High Performance Speaker Kit with cables, 96 dB HL

0004-03

Grason-Stadler

8103808

High Performance Speaker Kit with Booster Amplifier and cables, 100 dB HL - US Power Cord 100V to 240V

0004-04

Grason-Stadler

8100465

Isolation Transformer (Required When the GSI AudioStar Pro or the GSI Pello is Attached to a Booster,PC or Printer

0004-05

Grason-Stadler

8503180

Touch screen PC for use with GSl-AMTAS

0004-06

Grason-Stadler

8503192

GSl-AMTAS Upgrade kit (for existing AudioStar Pro) - see GSl-AMTAS requirements specifications. NOTE: System Serial Number and License Number required for Upgrade

0005

Grason-Stadler

GSI AudioStar Pro

GSI AudioStar Pro Supplies

0005-01

Grason-Stadler

8109155

AMBAND - Calibrated Bone Conduction Headbands (10)

0005-02

Grason-Stadler

8507203

Earphone Y-Cable (L and R)

0005-03

Grason-Stadler

8507208

P3045 Headband Only (Adult)

0005-04

Grason-Stadler

8507210

P3100 Pediatric Headband

0005-05

Grason-Stadler

8010894

Type 51 Earphone Cushion, Single

0005-06

Grason-Stadler

8104119

Bone Vibrator Assembly , B71,SO ohm

0005-07

Grason-Stadler

8101884

IP30 Insert earphones, 10 ohm

0005-08

Grason-Stadler

8520321

DD45O Headphones for High Frequency Audiometry (8000-20,000 Hz) and GSl-AMTAS

0005-09

Grason-Stadler

8503852

DD45 Audiometric Headset P3100 (Pediatric) Replacement Kit

0005-10

Grason-Stadler

8503851

DD45 Audiometric Headset P3045 (Adult) Replacement Kit

0006

Grason-Stadler

GSI AudioStar Pro

GSI AudioStar Pro CD s and Accessories

0006-01

Grason-Stadler

8515177

AudioStar Pro Software and Manuals, USB Bundle

0006-02

Grason-Stadler

8519002

Calibration App with Service Manual, English, USB

0006-03

Grason-Stadler

8518110

Talk Back Microphone (TB-2) with mounting bracket

0006-04

Grason-Stadler

8004361

Basic speaker cable for GSI AudioStar Pro

0007

Grason-Stadler

GSI Audera

The GSI Audera meets all of your needs for Evoked Potential testing by providing a unique combination of Auditory Evoked Potentials (AEP), Otoacoustic Emissions (OAE), and Auditory Steady State Response (ASSR) tests. Available with CE-Chirp and CE-Chirp Octave Band stimuli for frequency-specific threshold evaluations.

0007-01

Grason-Stadler

8519280

GSI Audera Pro - AEP/ASSR

0007-02

Grason-Stadler

8519281

GSI Audera Pro - AEP/OAE

0007-03

Grason-Stadler

8519282

GSI Audera Pro - AEP Only

0007-04

Grason-Stadler

8519283

GSI Audera Pro - OAE Only

0007-05

Grason-Stadler

8517151

GSI Audera Pro - Full Configuration (AEP/ASSR/OAE)

0008

Grason-Stadler

GSI Corti

The GSI Corti is a portable, battery-operated diagnostic and screening instrument that measures Otoacoustic Emissions (OAE) for infants, children, and adults. The Corti offers maximum speed and flexibility with pre-defined and user-defined protocols for Distortion Product Otoacoustic Emissions (DPOAEs) and Transient Evoked Otoacoustic Emissions (TEOAEs) measurements.

0008-01

Grason-Stadler

8104314

GSI Corti DPOAE Screening Unit

0008-02

Grason-Stadler

8104315

GSI Corti TEOAE Screening Unit

0008-03

Grason-Stadler

8104316

GSI Corti DPOAE + TEOAE Screening Unit

0008-04

Grason-Stadler

8104317

DPOAE Diagnostic Unit (Includes DPOAE Screening)

0008-05

Grason-Stadler

8104318

TEOAE Diagnostic Unit (Include TEOAE Screening)

0008-06

Grason-Stadler

8104319

DPOAE + TEOAE Diagnostic Unit (Includes DP and TE Screening)

0009

Grason-Stadler

GSI Tympstar Pro

GSI TympStar Pro offers comprehensive middle-ear testing capabilities that support the needs of hearing healthcare professionals. Change parameters on the fly or interpret results with the touch screen display. Protocols may be configured to optimize efficiency and workflow; the flexibility of pre-defined protocols saves time and creates consistency in testing procedures.

0009-01

Grason-Stadler

8108266

TympStar Pro Comprehensive Middle Ear Analyzer, Probe Assembly (226 Hz, 678 Hz and 1000 Hz) and Contra Phone

0010

Grason-Stadler

GSI Tympstar Pro

GSI Tympstar Pro Options

0010-01

Grason-Stadler

8109043

HP Office Jet Printer {6230 or equivalent)

0010-02

Grason-Stadler

8108894

Metal Test Cavities

0010-03

Grason-Stadler

8100465

Isolation Transformer (required when the GSI AudioStar Pro or the GSI Pello is attached to a Booster,PC or printer per UL/IEC/CSA 60601-1)

0011

Grason-Stadler

GSI Tympstar Pro

GSI Tympstar Pro Supplies

0011-01

Grason-Stadler

8109405

Probe Tip Replacement Kit (3)

0011-02

Grason-Stadler

8108944

Probe Floss Cleaning Kit

0012

Grason-Stadler

GSI Tympstar Pro

GSI Tympstar Pro CD s and Accessories

0012-01

Grason-Stadler

8108329

TympStar Pro Software and Manuals, USB Bundle

0012-02

Grason-Stadler

8503354

Calibration App with Service Manual, English, USB

0013

Grason-Stadler

Installation and Training

Â

0013-01

Grason-Stadler

GSI-INSTALL-ASP

Grason-Stadler Audio Star Pro Installation, Calibration & Training

0013-02

Grason-Stadler

GSI-INSTALL-CORTI

Grason-Stadler Corti Installation and Training

0013-03

Grason-Stadler

GSI-INSTALL-TSP

Grason-Stadler TympStar Pro Installation, Calibration & Training

0013-04

Grason-Stadler

GSI-INSTALL-UPGRADE

GSl-AMTAS Upgrade Kit Installation

The Department of Veterans Affairs (VA) is seeking vendors who can provide Grason-Stadler GSI® brand name Auditory Function Screening Device as listed above or equal commodities which meet all of the following salient characteristics. Vendors may quote any product solution or configuration so long as they meet the salient characteristics. Vendors are asked to quote any additional product that may be beneficial. These items must be captured in the vendor s pricing volume.

CLIN s 0001-0002 apply to the following salient characteristics for Auditory Function Screening Devices.

SC #

SALIENT CHARACTERISTICS

METHOD OF EVALUATION

PAGE # WHERE SC IS FOUND IN TECHNICAL LITERATURE

SC 1

Must have Tympanometry min 226 Hz - 1,000Hz.

Literature Review

SC 2

Contralateral reflex measurements up to 1,000 Hz, offers probe tone.

Literature Review

SC 3

Must be able to perform automated audiometry, advantageous to perform manually.

Literature Review

SC 4

Must test in IPSI and contralateral reflex measurements.

Literature Review

SC 5

Must have print formats.

Literature Review

CLIN s 0003-0006 apply to the following salient characteristics for Auditory Function Screening Devices.

SC #

SALIENT CHARACTERISTICS

METHOD OF EVALUATION

PAGE # WHERE SC IS FOUND IN TECHNICAL LITERATURE

SC 6

Must have multiple word recognition options.

Literature Review

SC 7

Must have QuickSIN, standard testing option, more options are advantageous.

Literature Review

SC 8

Built-in tools.

Literature Review

CLIN s 0007 apply to the following salient characteristics for Auditory Function Screening Devices.

SC #

SALIENT CHARACTERISTICS

METHOD OF EVALUATION

PAGE # WHERE SC IS FOUND IN TECHNICAL LITERATURE

SC 9

Impedance checks.

Literature Review

SC 10

Must be available with CE-Chirp stimuli.

Literature Review

SC 11

Data to screen options automated.

Literature Review

CLIN s 0008 apply to the following salient characteristics for Auditory Function Screening Devices.

SC #

SALIENT CHARACTERISTICS

METHOD OF EVALUATION

PAGE # WHERE SC IS FOUND IN TECHNICAL LITERATURE

SC 12

Must be able to do diagnostic and screening in Otoacoustic Emissions.

Literature Review

SC 13

Must be portable and rechargeable.

Literature Review

SC 14

Must have screening configurations preferably with DPOAE, TEOAE and combo DPOAE+TEOAE.

Literature Review

SC 15

Must have a minimum of fifteen (15) hours battery life.

Literature Review

SC 16

Must contain twelve (12) frequency DPOAE test and results display.

Literature Review

SC 17

Must have Data Manager Software.

Literature Review

SC 18

Must have Ear tip kit.

Literature Review

CLIN s 0009-0012 apply to the following salient characteristics for Auditory Function Screening Devices.

SC #

SALIENT CHARACTERISTICS

METHOD OF EVALUATION

PAGE # WHERE SC IS FOUND IN TECHNICAL LITERATURE

SC 19

Must have color touch screen interface.

Literature Review

SC 20

Must include shoulder probe mount.

Literature Review

SC 21

Must provide comprehensive standard protocols for diagnostic tests.

Literature Review

SC 22

Must offer built-in USB interface.

Literature Review

Definitions

GSI 39

IPSI Reflex

When a loud sound enters a normal ear, the stapedius muscle will contract on both sides regardless of which ear is stimulated. Therefore, the ART is a bilateral ("two side") reflex. Third, the word ipsilateral (ipsi) means "same side (contralateral (contra) means opposite side). A reflex in which the response occurs on the same side of the body that is stimulated.

Tympanometry

An examination used to test the condition of the middle ear and mobility of the eardrum (tympanic membrane) and the conduction bones by creating variations of air pressure in the ear canal. Tympanometry is an objective test of middle-ear function.

Audiometry

An exam tests your ability to hear sounds. Sounds vary, based on their loudness (intensity) and the speed of sound wave vibrations (tone). Hearing occurs when sound waves stimulate the nerves of the inner ear. The sound then travels along nerve pathways to the brain.

GSI AUDIOSTAR PRO

QuickSIN

The primary complaint of hearing-impaired persons is difficulty hearing in background noise. The

measurement of SNR loss (signal-to-noise ratio loss) is important because speech understanding in noise cannot be reliably predicted from the pure tone audiogram. The QuickSIN test was developed to provide a quick way for clinicians to quantify a patient s ability to hear in noise. SPEECH-IN-NOISE

BKB SIN

Bamford-Kowal-Bench Speech-in-Noise test.

TEN

Threshold Equalizing Noise Test

dB HL

Decibels Hearing Level

Noah 4

The Noah software system is designed specifically for the hearing care industry, providing hearing care professionals with a unified system for performing client-related tasks.

TDH

Telephonics Dynamic Headphone

AUDERA

CPT

The CPT coding system describes how to report procedures or services and is maintained and copyrighted by the American Medical Association. Each CPT code has five digits (e.g., 92557).

DPOAE

Distortion product otoacoustic emissions (DPOAE) are responses generated when the cochlea is stimulated simultaneously by two pure tone frequencies whose ratio is between 1.1 to 1.3.

TEOAE

Transient-evoked otoacoustic emission tests provide a quick and objective test of the cochlea's outer hair cells. A series of transient stimuli (wideband clicks or chirps) are sent into the ear canal.

ASSR

Auditory Steady-State Response--- an objective test used for evaluation of hearing ability in children too young for traditional audiometric testing. Most children are referred for ASSR after a newborn hearing screen in the hospital indicates the possibility of hearing loss.

AEP

Auditory-Evoked Potential--- used to determine if specific parts of the vestibular system are functioning properly. Evoked potentials, sometimes called evoked responses, record the amount of time the nerves take to respond to electrical and sound stimulation.

CAEP

Cortical Auditory-Evoked Potential--- Evoked potentials are small electrical signals that are produced by the hearing pathways in the brain. The response is measured from the brain. They can be recorded from the surface of the head.