J A_Redacted.pdf

Control No: JA16290

“For Official Use Only”

500-0112-28 QPC XScan 32 Military Version (without USB

USAMMA received an approved Information Technology Approval System (ITAS) waiver from the Army Medicine Chief Information Officer/G-6 Office, dated 19 July 2016, for this requirement.

4. Authority Cited: The statutory authority permitting other than full and open competition is 10 United States Code 2304(c)(1) as implemented by Federal Acquisition Regulation 6.302-1(a), Only One Responsible Source and No Other Supplies or Services will Satisfy Agency Requirements.

5. Reason for Authority Cited: iCRco, Inc. is the only authorized manufacturer of the proprietary software that will be loaded onto the Dell Latitude laptops. There are authorized resellers for iCRco, Inc. brand items that are available in the commercial market. However, this non-commercial software is available only from the original equipment manufacturer (OEM), iCRco, Inc. Therefore, this procurement action will be accomplished through a sole source award to iCRco, Inc., 26 Coromar Drive, Goleta, CA 93117.

USAMMA has three medical equipment repair depots in Tobyhanna, Pennsylvania;

Tracy, California; and Hill Air Force Base, Utah. Medical equipment used by deployed forces in Afghanistan is returned to one of the three depots for repair, refurbishment, or replacement when the repair issue exceeds the deployed unit’s maintenance capability. There are limited spares in theater, so repair and return is a high priority activity at USAMMA’s depots.

With very few exceptions, medical equipment repair parts are available only from the manufacturer of the equipment or from a firm that has been licensed by the manufacturer to produce authorized parts. This conclusion is based on Army and Food and Drug Administration (FDA) regulations and market research. Army Regulation (AR) 40-61, Medical Logistics Policies, prohibits modifications or alterations of Army medical equipment without the manufacturer’s consent. Section 6-17 provides that even “minor alterations without the manufacturer’s consent may negate any further manufacturer product liability.” AR 40-61 lists four circumstances under which Army medical maintenance personnel may modify medical equipment: modification work order, quality assurance alteration, minor alteration, and component modernization. All require manufacturer involvement or consent.

USAMMA is the Army’s medical manager and therefore considers any medical equipment alteration, including the substitution of manufacturer-provided or approved repair parts with other repair parts to be contrary to Army and FDA regulations, endangering the device’s FDA certification, and incurring product liability on behalf of the Army. As these computers with loaded with the QPX XScan software are required to operate the CR readers, these laptops are considered to be repair items for medical equipment as the CR readers cannot operate with these computers.

6. Efforts to Obtain Competition: For previous Purchase Orders issued for commercial (non-IT) parts manufactured by iCRco, Inc., the Government was able to locate third party resellers that are authorized by the OEM, such as Tryco, Inc.

However, based on direct communication with Global Sales Manager, on 14 July 2016, this software can only be sourced directly from iCRco, Inc.

Additionally, as required by USAMRAA policy, a Request for Information was posted to FedBizOpps on 22 July 2016 to seek information from sources expressing interest in this acquisition. No responses were received from interested sources as of 4 August 2016.

7. Actions to Increase Competition: USAMMA conducts online research as part of its periodic market research efforts to locate other available sources that are capable of meeting these types of requirement in the future. Additionally, the Government may post an updated Request for Information (RFI) for any future procurement to determine if there are sources available in the market place that can meet the Government’s need.

If the RFI shows there are competitors in the market place, future acquisitions may be competed.

8. Market Research: Thorough market research has been completed by both USAMMA and USAMRAA for the requiring activity’s ongoing need for medical equipment repair and replacement parts. While this market research located multiple third party resellers/distributors that are authorized vendors for this manufacturer, previous acquisitions for this specific software as well as direct communication with iCRco, Inc. have confirmed that the XScan software is not distributed or sold by any other vendors and that it is only sourced directly through iCRco, Inc.

A similar requirement that was awarded for laptops loaded with XScan software (Purchase Order number W81XWH-15-P-0336) was reviewed as part of the market research efforts for this requirement. A Request for Information (RFI) was posted to FedBizOpps on 1 May 2015 under solicitation number W81XWH-15-T-0155 for this previous requirement. This RFI was posted to ascertain whether there are any alternative sources in the open market that can provide brand name or equal parts that will satisfy USAMMA’s need for this software needed as part of the CR reader. No responses were received by the Contract Specialist as a result of the May 2015 RFI posting. As this RFI posting is within 18 months, this is considered to be current market research for the subject requirement, in accordance with FAR 10.002(b)(1).

Additional market research was conducted on 21 July 2016 for this requirement.

Specifically, the Contract Specialist completed searches on GSA Advantage for the specific software included in the table above. This search revealed no results. The Contract Specialist also searched GSA eLibrary to determine if the manufacturer has a GSA contract. In addition to this search, direct correspondence with the Global Sales Manager for iCRco, Inc., , confirmed that iCRco, Inc. does not have a GSA contract. Therefore, the Contract Specialist has determined that these items are only available through the open market.

Finally, as previously stated, a Request for Information was posted to FedBizOpps on 22 July 2016 to seek information from interested sources that may be able to meet the requirements of this purchase. No responses were received from interested Offerors.

9. Interested Sources: In accordance with FAR 5.201, a notice of intent to sole source will be published on FedBizOpps on or about 10 August 2016 under solicitation number W81XWH-16-T-0343. This announcement will detail the Government’s intent to purchase the required items on a non-competitive basis. Any responses received will be reviewed for the purpose of determining whether a competitive procurement is in the best interest of the Government.

The Government does not anticipate any actions that the agency could take to remove or overcome any barriers that led to the restricted consideration before any subsequent supplies is made.

10. Other Facts:

a. Procurement history.

(1) Contract numbers and dates of the last several contracts for these same requirements: As previously stated, a similar Order has been issued by USAMRAA for the XScan software and laptops. The Purchase Order number is W81XWH-15-P-0336, which was awarded on 7 August 2015 to iCRco, Inc. in the amount of $431,025.10.

(2) Competitive status of these actions: This Purchase Order was accomplished on a sole source basis and awarded directly to iCRco, Inc.

(3) Authority previously used for less than full and open competition: The authority cited for other than full and open competition was FAR 6.302-1(a)(2). The J&A control number is JA15179.

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results: The paragraph 7 for this previous J&A stated that:

The Government will periodically conduct market research and/or analysis to determine if the manufacturer has changed the equipment component list to specify a different replacement part that may be available from other suppliers. At present, the required software is unique to iCRco and must be obtained from the manufacturer who is the only distributor for their manufactured medical replacement parts. Due to future changes in the customer’s technological requirements, more competition may occur to allow for other vendors in the market to compete against orders for similar items. If at some point in the future, iCRco allows other commercial entities to operate as authorized resellers of iCRco manufactured parts; such future sources will be considered for award.

Note, however, that based on recent market research to include direct communication with the manufacturer, the specifics regarding the purchase of this software have not changed. This is still the required software needed for the repair of the CR readers and it is only available from the manufacturer directly.

(5) If any prior award was accomplished by full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources: Not applicable

(6) An explanation of any unusual patterns which may be revealed by the history, e.g., several consecutive, urgent buys: No unusual patters were found.

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the buy and whether there have been any significant changes: As stated under 4 above, based on recent market research to include direct communication with the manufacturer, the specifics regarding the purchase of this software have not changed. This is still the required software needed for the repair of the CR readers and it is only available from the manufacturer directly.

b. Other facts: Not Applicable

11. Technical Certification:

I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

Typed Name: _ ______ Date: 8/8/2016

Title: Equipment Specialist Signature: ___

12. Requirements Certification:

I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

Typed Name: Date:8/8/16

Title:Deputy M3D, USAMMA Signature:

13. Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable.

Price Reasonableness will be determined using the manufacturer’s published price list as well as copies of previous contracts awarded or previous quotes/invoices for the same items, per FAR Part 15.404-1(b)(2)(ii) and 15.404-1(b)(2)(iv) . The price reasonableness determination will also be based on a comparison with the Independent Government Cost Estimate in accordance with FAR 15.404-1(b)(2)(v). Certified Cost or Pricing data will be required as none of the exceptions at FAR Part 15.403 apply to this requirement.

Typed Name: _ __ Date:

Title: ______Contracting Officer Signature: _______________

14. Contracting Officer Certification:

I certify that this justification is accurate and complete to the best of my knowledge and belief.

Typed Name: _ __ Date: ___________________

Title: ____Contracting Officer___ Signature: _______________