JA-18-98-Redacted.pdf

Control No: JA-18-98

"For Official Use Only”

Sole Source Justification (SSJ) in accordance with FAR subpart 13.106 using Simplified Acquisitions Procedures (SAP)

Brand Name Philips Healthcare Repair Parts

1. Contracting Activity: The Contracting Activity responsible for this action is the U.S.

Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, MD.

2. Requiring Activity: The U.S. Army Medical Materiel Agency (USAMMA), 693 Neiman Street, Fort Detrick, MD 21702. The required items will be delivered to the USAMMA Medical Maintenance Operations Division depot located at 25600 S.

Chrisman Rd. BlDG T-255, Tracy, CA 95304-9150

3. Nature of Action:

Commercial Item Non-Commercial Item New Requirement Follow-on Requirement Mod to Existing Purchase Order/Contract Number

Pricing: Firm-Fixed Price* Time & Materials** Cost*

* See FAR 12.207(a) ** See FAR 12.207(b)

For Hybrid Contracts, list percentage of each type of pricing:

* Firm Fixed Price: ________

**Time & Materials: ________

* Cost: ________

Funds: RDT&E Operations and Maintenance, Army (OMA)

Other Funds:

Fiscal Year of Funds: FY18

Estimated Total Dollar Value including Options: $655,721.94

4. Contractor Name:

Name of Proposed Contractor(s): Philips Electronics North America Corp Street Address: 3000 Minuteman Road MS 0077 City, State, Zip: Andover, MA 01810-1032 Phone: 978-659-4278

DUNS: 153882816

Cage Code: 0ZBJ4

"For Official Use Only”

5. Description of Supplies/Services: The requirement is for 93 brand name Philips Healthcare parts needed to repair Computed Tomography (CT) machines used by deployed forces in theater. All required parts will be shipped to the USAMMA’s medical equipment repair depot located in Tracy, CA. Table 1 identifies the required brand name Philips Healthcare CT parts.

Table 1: Brand Name Philips Healthcare Parts Part Description Part Number Price QTY Cost

GANTRY JUMPER KIT CT 453567001111 1090.54 1 1,090.54

IQ TOOL KIT CT 453566284931 583.95 1 583.95

TOOL STANDARD SERVICE 453566272391 8904.6 1 8,904.60

CIRCUIT BREAKER X-RAY 453567014341 161.5 2 323.00

TOOL KIT SOFTWARE CT 453567026041 70.55 1 70.55

INTERRUPTER ASSEMBLY 453567006161 386.75 1 386.75

SOFTWARE DOWNLOAD KIT 453567399891 1090.55 1 1,090.55

PROCESSOR TILT DRIVE 453566502391 8030.8 1 8,030.80

PROCESSOR GANTRY MO 453567010351 5050.7 1 5,050.70

INTERFACE DUAL TILT 453566502751 1960.95 1 1,960.95

GHOST ASSY CT SCANNER 453567110321 5179.05 1 5,179.05

TRANSMITTER ROTOR OPT 453567012841 6297.65 1 6,297.65

BLOCK SIGNAL BRUSH 453567012031 2011.1 8 16,088.80

POWER SUPPLY CT SCAN 453567449761 2933.35 1 2,933.35

MODULE OPTICAL STATOR 453567012851 6555.2 1 6,555.20

POWER SUPPLY CT SCAN 453567080292 2965.65 1 2,965.65

GUIDE WAVE ASSY CT 453567141931 664.7 35 23,264.50

POWER SUPPLY SINGLE 453567080282 2620.55 1 2,620.55

PRISM BLOCK ASSY F/CT 453567032881 1601.4 1 1,601.40

BLOCK POWER BRUSH CT 453567133801 2219.35 9 19,974.15

BELT ENCODER CT SCAN 453567041721 45.05 9 405.45

SWITCH TAPE CT SCAN 453567032051 138.55 16 2,216.80

SWITCH E-STOP CT SCAN 453566420731 130.9 33 4,319.70

CONTROLLER MAIN DRIVE 453566460131 8035.05 1 8,035.05

CONTROLLER ACS CT 453567139462 5898.15 1 5,898.15

FAN COOLING CT SCAN 453566495401 406.3 16 6,500.80

DATA MANAGEMENT PWRCT 455012003032 22053.25 1 22,053.25

CONTROLLER ASSY CT 453567017751 8450.7 1 8,450.70

FUSE KIT CT SCANNING 453567045792 3193.45 1 3,193.45

CONTROLLER SERVO CT 453566492551 5144.2 1 5,144.20

SPECTACLES PROTECT CT 453567061821 537.2 1 537.20

SPECTACLES PROTECT CT 453567069641 537.2 2 1,074.40

FAN TUBE AXIAL 6X6X4" 453566503142 478.55 16 7,656.80

SWITCH VERTICAL SFT 1S 453566148311 130.05 16 2,080.80

BOTTLE WATER 1S 453566200321 18.7 52 972.40

X-RAY TUBE COOL UNI 1S 451214872142 16830 1 16,830.00

SWITCH HARD LIMIT 1S 453566077822 94.35 18 1,698.30

C0NTR0L BOARD W/CPM 1S 453566457351 8030.8 1 8,030.80

HORIZONTAL SWITCH 1S 453566489551 168.3 1 168.30

CABLE VERTIC/BRAKE 1S 453566491851 263.5 1 263.50

CABLE "IN" LIMIT 1S 453566491941 102.85 1 102.85

CABLE LIMIT RELAY 1S 453566491961 280.5 1 280.50

BELT MAIN DRIVE 1S 453566492401 576.3 8 4,610.40

HORIZONTAL DRIVE BT 1S 453566496971 50.15 8 401.20

ENCODER CT 1S 453566500901 1090.55 8 8,724.40

ENCODER ABSOLUTE 1S 453566500911 3347.3 8 26,778.40

HEAT FAN INTERFACE 1S 453566501421 135.15 1 135.15

CAM TILT LIMIT 1S 453566502211 51.85 8 414.80

LIMIT SWITCH HORIZO 1S 453566503471 109.65 18 1,973.70

BELT ANGULATION POT 1S 453566503531 85 8 680.00

POWER BRUSH BLOCK 1S 453567012021 2219.35 4 8,877.40

LEXAN RING 1S 453567015994 2509.2 6 15,055.20

SILICON PASTE P4 1S 453567023141 393.55 1 393.55

FOOTSWITCH INNER CV 1S 453567025601 612.85 1 612.85

CT BOX 1S 453567027192 7439.2 1 7,439.20

LEAD SCREW HRZN DR 1S 453567028971 2955.45 2 5,910.90

HANDLE TAPE SWITCH 1S 453567032061 189.55 1 189.55

GSU TO RECON 100FT 1S 453567034411 374 8 2,992.00

WAVE GUIDE SETTING 1S 453567039071 714.85 1 714.85

HORIZONTAL BRAKE 1S 453567045171 505.75 1 505.75

SPRING COMPRESSOR 1S 453567050051 17.85 40 714.00

FOOT PEDAL 1S 453567058051 2423.35 1 2,423.35

FOOTSWITCH COVER 1S 453567066371 334.05 1 334.05

PHANTOM CT 1S 453567135962 8273.05 1 8,273.05

SAFETY BAR BRACKET 1S 453567247021 17 9 153.00

SATA HARD DRIVE 1S 453567374732 1049.75 1 1,049.75

AIR FILTER VERTICAL 1S 453567374791 125.8 1 125.80

ADAPTER SINGL SC-SC 1S 453567385771 94.35 7 660.45

KIT LEFT HAND COVER 1S 453567442291 728.45 8 5,827.60

KIT RGHT HAND COVER 1S 453567442301 728.45 8 5,827.60

RING SLIP CLEANING 1S 453567459841 1178.1 1 1,178.10

VS1 CDROM (DVD-ROM) 1S 453567534441 272.85 1 272.85

KIT-ENCODER BELT 1S 453567535032 45.05 7 315.35

FAN EXHAUST 1S 453567553391 505.75 16 8,092.00

PCB /W AMD CHIP 1S 453567556771 1707.65 1 1,707.65

CABLE RCOM TO ROTOR 1S 453567025841 160.65 1 160.65

EBW V4.5.4 SW KIT 1S 455011302365 43.35 8 346.80

OPTICAL FIBER CABLE 1S 455012303691 164.05 7 1,148.35

FIBER OPT CABLE B16 1S 455012305371 215.9 7 1,511.30

OPTIC CABLE 20M 1S 455012305381 827.9 1 827.90

DMS LEFT MOTHERBRD 1S 455014003062 4139.5 1 4,139.50

BATTHERY LIT3V COIN 1S 455017810021 35.7 3 107.10

CABLE ACQ-GANTRY 1S 459800210551 64.6 7 452.20

CABLE RCOM2-ROTOR 1S 459800210591 91.8 7 642.60

POWER SUPPLY 110V 1S 459800231241 652.8 1 652.80

CABLE ASSY 1M FIBER 1S 459800239481 56.1 7 392.70

FIBER OPTIC ADAPTER 1S 459800266191 20.4 7 142.80

CABLE FOOTSWITCH 1S 459800359221 649.4 1 649.40

DRIVE FRU KIT 500GB 1S 459800386851 418.2 1 418.20

COUCH SKIRT LIFTING 1S 459800721901 255 2 510.00

GANTRY LH REAR 1S 459800827201 2358.75 1 2,358.75

X-RAY TUBE 1S 989000085892 146400 2 292,800.00

ANTI SCATTER GRID (100CM) 9896-010-61301 4210.9 1 4,210.90

Total Cost $655,721.94

6. Authority Cited: 41 U.S.C. 1901 OR 41 U.S.C. 1903

(a) FAR 13.106-1(b)(1)(i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization); OR

(b) FAR 13.106-1(b)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item; OR

I FAR 13.501(a)(1)(i): Only one source reasonably available (including brand name); OR

(d) FAR 13.501(a)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item.

7. Reason for Authority Cited: Philips Healthcare is the only authorized manufacturer and source for all 93 specific medical equipment components listed in Table 1 above.

Therefore, the parts listed above will be purchased by the Government directly from the manufacturer’s subsidiary company, AllParts Medical, or authorized distributors on a brand name only basis.

USAMMA has three (3) medical equipment repair depots located in Tobyhanna, Pennsylvania; Tracy, California; and Hill Air Force Base, Utah. Medical equipment used by deployed forces around the world 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.

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 as well as 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 instances under which Army medical maintenance personnel may modify medical equipment to include: (1) modification work order; (2) quality assurance alteration; (3) minor alteration; and (4) component modernization. All four instances require the 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.

8. Efforts to obtain Competition: Multiple third party distributors have been identified for the AllParts Medical brand name parts required by USAMMA. Specifically, the requiring activity identified three (3) authorized distributors capable of providing parts manufactured by AllParts Medical to include: (1) Two Rivers, (2) Tryco, and (3) AllParts Medical. Additionally, in accordance with FAR subpart 5.2, a Notice of Intent will be posted to FedBizOpps on or about 30 March 2018. This announcement will allow for the submission of Capability Statements from other manufacturers or resellers that propose to have products that can meet the Government’s need for brand name repair parts. Any responses received will be reviewed for the purpose of determining whether a competitive procurement is in the best interest of the Government.

a. Effective competition. As previously stated, market research has revealed that multiple distributors are able to provide the brand name Philips Healthcare products.

Therefore, the Government intends to request quotes from all Philips Healthcare authorized distributors.

b. Subcontracting competition. Not applicable; as this is a supply-type requirement, the Government does not anticipate subcontracting competition opportunities.

9. Actions to remove or overcome barriers Competition: USAMMA conducts online research as part of its periodic market research efforts to locate other available sources that are capable of meeting this requirement in the future. Additionally, the Government may post a Request for Information (RFI) for any future procurement to determine if there are additional sources available in the market place that can meet the Government’s need.

10. Market Survey: Thorough market research has been completed by both USAMMA and USAMRAA for medical equipment repair and replacement parts. The recent market research efforts include posting a Notice of Intent to Sole Source for a similar requirement on 14 March 2018, direct correspondence with the manufacturer during March 2018, and searches on GSA Advantage to determine availability of these items through required sources. See below for the details of these market research efforts.

Additional market research was conducted on 14 March 2018 for this requirement.

Specifically, the Contract Specialist completed searches on General Services Administration (GSA) Advantage! for a sample of the required brand name Philips Healthcare parts included in Table 1. This search revealed no results for the required brand name parts including a review of Philips Healthcare’s GSA contract for medical equipment and supplies (V797P-2238D). In addition to this search, direct correspondence with the Regional Sales Manager for Philips Healthcare, Mr. Tim Muller, confirmed that Philips Healthcare does not offer the required parts through GSA.

Therefore, the Contract Specialist has determined that these items are only available through the open market.

Finally, USAMMA conducted additional market research on 14 March 2018 using the Medical Product Data Bank (MedPDB) to search for potential purchasing options. The MedPDB is a system that resulted from the Defense Logistics Agency Troop Support and the Department of Veterans Affairs (VA) partnership to enable synchronizing of key data across their joint enterprise. The primary purpose of the MedPDB application is to make data from the MedPDB visible to the DoD and VA business processes. The PDB is used to help identify contracts and pricing instruments available to the DoD and VA enterprises. The MedPDB helps identify the best cost for an item via a particular contract or pricing instrument (e.g. FSS/BPA/DAPA/ECAT, etc.); assist in finding alternate sources of supply when an item goes on backorder from the main source of supply; and provides visibility of what peers are buying, where they are buying it from, and what their cost is for a medical supply item. The result of the search was unsuccessful in identifying the required brand name parts; therefore, these items are only available through the open market.

11. Interested Sources: A combined synopsis/solicitation will be posted to FBO along with the redacted Brand Name Sole Source Justification. All authorized distributors for Philips Healthcare will be eligible to submit a response to the solicitation.

12. Procurement History and any other facts:

Previous Contract or Purchase Order Number: Not applicable

Previously competed? Not applicable

Previous authority for less than Full & Open Competition: Not applicable

13. Technical / Requirements Certification: I certify that the support data under my cognizance which are included in this SSJ are accurate and complete to the best of my knowledge and belief.

14. Contracting Officer Certification and Approval: I certify that this justification is accurate and complete to the best of my knowledge and belief. Based upon the facts described herein, I hereby determine that the anticipated price to the Government will be fair and reasonable, and a determination of price reasonableness will be documented and placed in the contract file.

Date: