Limiting Sources Justification - MPT-SAT.docx

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6515--Supply, WatchPAT Sleep Study Devices Cincinnati VAMC
Solicitation number
36C25025Q0556
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The document is a Limiting Sources Justification (LSJ) for Micro-Purchase Threshold up to the Simplified Acquisition Threshold (SAT) for the Department of Veterans Affairs. The justification relates to a procurement for WatchPAT 300 Sleep Apnea Devices for the Cincinnati VA Medical Center, located in Veterans Integrated Service Network (VISN) 10. The contract was awarded to ITAMAR MEDICAL, INC. for $28,590.15, with an award date of May 22, 2025, under solicitation number 36C25025Q0556. The procurement supports medical equipment needs for the Veterans Health Administration, specifically targeting sleep study diagnostic devices for a specific VA medical facility.

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Attachment 1: Justification for Limiting Sources for Micro-Purchase Threshold up to the SAT

DEPARTMENT OF VETERANS AFFAIRS

FAR 8 – Justification for Limiting Sources (LSJ) For Limiting Sources (<SAT)

Acquisition Plan Action ID: 36C250-25-AP-2292

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO) 10, located at 260 E University Avenue, Cincinnati, OH 45219-2356, in support of VISN 10 Cincinnati Veterans Affairs Medical Center (CVAMC) at 3200 Vine Street, Cincinnati, OH 45220-2213. 2237 #: 539-25-2-043-0107.

2. Description of Action: The CVAMC’s Sleep Section provides medical treatment to veterans who suffer from sleeping disorders. This new one-time request for a firm fixed price award is for the procurement of the brand name WatchPat 300 devices and accessories required to conduct sleep studies.

Order against: |X| FSS Contract Number: 36F79723D0108

Name of Proposed Contractor:
Itamar Medical, Inc (dba Zoll) (Large Business)
Street Address:
3290 Cumberland Club Drive, Suite 100
City, State, Zip:
Atlanta, GA 30339-4914
Phone:
(888)748-2627

3. Description of Supplies or Services: Services provided to veterans being treated for sleeping disorders have traditionally only been offered at the VA Medical Center Sleep Lab. Patients were required to come into the hospital and stay overnight. During the COVID-19 pandemic, safely providing services at the medical center became difficult. Many veterans were unable to receive these services. The clinicians decided to seek other alternatives to provide sleep study services to our veterans. CVAMC of sleep apnea that are similar to test results obtained when patients are seen at the medical center.

The device is an FDA-Cleared portable home sleep apnea test (HSAT), and diagnostic device designed to allow patients to participate in Sleep Apnea Studies from the comfort of their homes. The unit is then returned to the facility for analysis. It aids clinicians with the process of diagnosing sleep apnea including obstructive and central sleep apneas. In addition to offering similar test results, it saves veterans time by eliminating the need of multiple visits to the medical center, reduces their burdens of sleeping away from home, and incurring other unnecessary expenses. Additional units of the device and accessories are needed to provide medical support to additional patients. The following supplies/services are needed.

· AC2101300 - 12 WHITE WATCHPAT300 UPAT PROBES – Quantity of 6 Each

· AC2000110 - ADHESIVE SET FOR SBP SENSOR - Quantity of 6 Each

· AC3000305 - CENTRAL PLUS ADD-ON KIT WITH RESBP - ONLY FOR WP200U - Quantity of 5

· AC2110701 - WATCH-PAT300 - Quantity of 5 Each

Initial market research was completed by the service. They reviewed the market research results from a similar procurement at the Cleveland VAMC. The OEM was contacted to determine the current market conditions and product availability. An informal pricing quote was provided.

Additional market research queries were then conducted by the Contracting Specialist using VetCert, Veterans Affairs National Acquisition Center (VA NAC) MedSurg Catalog Search, GSA Advantage, Small Business Administration Dynamic Small Business Search (SBA DSBS), NASA SEWP, and Federal Procurement Data System (FPDS-NG) databases and other sources with NAICS Product Code 334510, keywords “watch pat device,” item description/part number, and the OEM name. AbilityOne’s online catalog was reviewed. A follow-up email was also sent to the OEM to confirm any authorized resellers.

The market research findings resulted in one (1) FSS Contract (36F79723D0108 – Expiring 04/30/2028) held by the large business OEM. One (1) SEWP Contract Holder (large business) offered eight (8) items manufactured by the OEM. None of the items needed for this requirement were included. The OEM identified two (2) VetCert certified small-disabled veteran owned small business (SDVOSB) resellers of their products/services via email response on 05/01/2025. However, according to the OEM, only one (1) of the SDVOSB resellers can provide all products/services for this requirement. Open market pricing would be offered.

There is no reasonable expectation of receiving offers from two or more capable small business concerns. The VA and SBA Rules of Two cannot be obtained. It is determined that the best value for the Government is a firm fixed price award with the OEM large business using the FSS contract pricing available.

The estimated value of the proposed action is $ 28,590.15.

4. Authority:

Order Against FSS: Authority of the Multiple Award Schedule Program, Title III of the Federal Property and Administrative Services Act of 1949 (41 USC 251, et seq.); Title 40 USC 501, Services for Executive Agencies; and Section 803 of the National Defense Authorization Act of 2002 (PL 107-107) and implemented by FAR 8.405-6. Mark the applicable exception:

|_| An urgent and compelling need exists, and following the procedures would result in unacceptable delays(FAR 8.405-6(a)(1)(i)(A);

|_| Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; (FAR 8.405-6(a)(1)(i)(B));

|_| In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order and the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order was not previously issued under sole-source or limited-sources procedures (FAR 8.405-6(a)(1)(i)(C)); or

|X| Items peculiar to one manufacturer. An item peculiar to one manufacturer can be a particular brand name, product, or a feature of a product, peculiar to one manufacturer). A brand name item, whether available on one or more schedule contracts, is an item peculiar to one manufacturer (FAR 8.405-6(b)).

5. Rationale/explanation to support cited authority: The WatchPat device utilizes the proprietary Peripheral Arterial Tone (PAT) signal. It calculates apnea-hypopnea index (AHI) and, respiratory disturbance index (RDI) using the patient’s total sleep time rather than the recorded time used in most commercially available HSATs, reducing the risk of underdiagnosis. It has a “3 points of contact” design that offers comfortability with use. It provides quickly download times with one-step processing. Physicians have real-time access to sleep data, study results, and are able to access patient data collected within the past two years.

The supplies/services must be compatible in all aspects (form, fit, and function) with existing systems presently installed/performing. Other sources cannot obtain OEM manufacturer’s parts and diagnostic equipment necessary to restore equipment to 100% functionality and to ensure adherence to manufacturer’s specifications.

6. BRAND NAME ONLY: This buy is estimated to exceed $25,000 and this documentation will be posted along with the RFQ on e-Buy, as required by FAR 8.405-1(e).

7. Note that this determination satisfies the requirements of FAR 8.405-6. The requirement to prepare a written justification IAW FAR 6.303 does not apply to Federal Supply Schedules.

VHAPG Part 808.405-6 Limiting Sources Page 1 of 3 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 539-25-2-043-0107

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