A03_18-R-0098_J&A_18-233_08-17-2018_Redacted.pdf

Control No: 18-233

“Official Use Only”

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

Brand Name Philips Medical Systems 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 T255, Tracy, CA 95340-9150.

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: $1,619,110.80

4. Contractor Name:

Name of Proposed Contractor(s): Allparts Medical, LLC (Philips Medical Systems. is parent company) Street Address: 400 Brick Church Park Dr.

City, State, Zip: Nashville, TN, 37207 Phone: 615-620-8539

DUNS: 050471416

Cage Code: 58UB6

Name of Proposed Contractor(s): TQM, LLC dba Two Rivers Medical Street Address: 1551 Wal Street, Suite 240 City, State, Zip: Saint Charles, MO 63303-3541 Phone: 864-968-4121

DUNS: 883012874

Cage Code: 0ZSM5

Name of Proposed Contractor(s): PartsSource, Inc.

Street Address: 777 Lena Drive City, State, Zip: Aurora, OH 44202-8025 Phone: 877-497-6412

DUNS: 099975109

Cage Code: 3MGDO

5. Description of Supplies/Services: The requirement is for brand name Philips Medical Systems repair parts needed to repair Philips Imagining units 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 Medical Systems repair parts.

Table 1: Brand Name Philips Medical Systems Repair Parts

Part Number Description Qty Total Value

453566200321 Phantom Water (bottle with label and phantom water) 8 $149.60

453566353932 Cushion, Knee Rest (old part # 4535 663 53931) 4 $1,251.20

453566371911 Patient Restraint Upgrade 4 $3,648.20

453567030281 Cushion, Patient Support Yellow (mattress) 4 $3,019.20

453567049571 Arm Rest, Black Plastic 4 $1,111.80

453567104512 Foam, Head Clamp (Head Cushion) 4 $1,948.20

453567104591 Single Strap 4 $217.60

453567111051 Headrest Strap Assembly 4 $360.40

453567218031 Pads, Head Positioning (Foam Rectangles – Set of 4) 4 $74.80

453567055351 Filter Air (Lower Gantry) 8 $1,400.80

453567374791 Vertical S1 server Air Filter (Rev. C & Up Chassis) 8 $1,006.40

453567018751 Filter, Air 6 x 19 x .5 (Computer Cabinet) 8 $1,006.40

453567018801 Filter, Air 6 x 13 x .5 (Computer Cabinet) 8 $2,502.40

453566077822 Hard Limit Switch 8 $754.80

453566147251 White Cover Switch 8 $360.40

453566148311 Limit Switch 8 $1,040.40

453566420731 E-Stop Switch, DPDT, Plunger 8 $1,047.20

453566492401 Belt Main Drive Poly V 4 $2,305.20

453566495401 Fan, Cooling, DMS (Data Measurement System) 4 $1,625.20

453566496971 Horizontal Drive Belt 4 $200.60

453566500901 Encoder, CT Positional go to 459801254991 4 $4,362.20

453566500911 Encoder, CT Absolute 4 $13,389.20

453566502211 CAM Tilt Limit 4 $207.40

453566503142 FAN Tubeaxial 4 $1,914.20

453566503471 Limit Switch, Horizontal In 4 $438.60

453566503531 Belt , Angulation Pot 4 $340.00

453567141931 Wave Guide Assy 2 $1,329.40

453567014341 Breaker 4 Amp 4 $646.00

453567015994 Lexan Ring 4 $10,036.80

453567032051 Tape Switch 17"(Foot Switch) 8 $1,108.40

453567034411 Fiber, Optic Single, GSU to RECON, 100 Ft 4 $1,496.00

453567041721 Belt Replacement Kit w/ O-rings 4 $180.20

453567050051 Spring Compression 4 $71.40

453567247021 Limit Switch Safety Bar Brkt 4 $68.00

453567385771 SC-SC Fiber Optic Single Adapter 4 $377.40

453567385841 Fiber Optic Cable 4 LC-LC + 1 SC-SC 4 $6,704.80

453567535032 Belt Encoder, kit 4 $180.20

453567553391 Fan - 10 inch axial 4 $2,023.00

455012005441 Host Rack Fans Assembly 2 $2,516.00

455012303691 Optical Fiber Cable 4 $656.20

455012305371 Gantry Fiber Optic Cable 20 M 4 $863.60

459800210551 Cable, 3M fiber, ACQ to Gantry, LC-LC 4 $258.40

459800210591 Cable, 3M fiber, RCOM2 to Rotor, LC-SC 4 $367.20

459800239481 Cable Assy 1M fiber, C-SC 4 $224.40

459800266191 Fiber optic FIS SC Adapter 4 $81.60

459800325761 Signal Brush Blocks 4 $8,044.40

459800325772 Power Brush Block 8 $17,754.80

453567084502 Circuit Board, Gantry Motion Processor 2 $12,700.70

453566457352 Couch Contol Board Assy w/ CPM 3 $24,092.40

453566460131 Assemble, Main Drive Processor (MDP) 4 $32,140.20

453566489551 Assy, Horizontal Limit Switch, Out 4 $673.20

453566491851 CBL, Vertical Limit/Brake 4 $1,054.00

453566491941 CBL, "in" Limit 4 $411.40

453566491961 CBL, CT Limit relay FDBK & Tape 4 $1,122.00

453566492551 Servo Controller(Spindleblock) 1.0 2 $10,288.40

453566501421 CBL, Heat Xchg Fan interface 4 $540.60

453566502022 Phantom Holder, Carbon Top 4 $3,719.60

453566502391 Tilt Drive Processor 2 $16,061.60

453566502751 Dual Tilt Interface 2 $3,921.90

453566503791 Filter, Air 8.5 x 11.5 x .5 (Gantry, Upper Right) 4 $486.20

453567006161 ZERO POS. INTERUPTOR ASSY 4 $1,547.00

453567012841 Transmitter, Rotor Optical 2 $12,595.30

453567012851 Module, Optical RX, Stator 2 $13,110.40

453567017751 Assembly, Controller, Rotating 2 $16,901.40

453567021001 Eye Calibration Phantom 4 $9,795.40

453567025601 Footswitch Inner Cover 4 $2,451.40

453567025841 CBL, Fibre RCOM to Rotor Interface 4 $642.60

453567027192 CT Display Box w/ RARI, Tilt 1 $7,439.20

453567028512 APM ASSY W/ DUAL TUBE STARTER (replaces part # 67028511)

1 $43,848.95

453567028521 CATHODE POWER MODULE, CPM ASSY. 1 $43,222.50

453567028971 Lead Screw, Horizontal Drive 4 $11,821.80

453567032061 CBL, Handle tape switches 4 $758.20

453567032881 Light Source Block Assembly 2 $3,202.80

453567033081 Cable, Footswitch 2 $2,602.70

453567033831 CPM PCB Prgrm's (/w AMD CHIP) 2 $10,135.40

453567039071 Wave guide setting tool 2 $1,429.70

453567045171 Horizontal Brake 8 $4,046.00

453567045792 Fuse Kit, CT System 1 $3,193.45

459800075691 Quick Lock Assembly (couch lock front) 4 $982.60

453567055351 Filter Air (Lower Gantry) 4 $700.40

453567057181 Carbon Top, Couch w/ front cutout 1 $12,540.90

453567058051 Foot Pedal 2 $4,846.70

453567061821 Laser Glasses 1 $537.20

453567062791 Right Rear Control Panel 4 $9,435.00

453567066141 Paint, Touch up (brush), Silver 1 $22.95

453567066151 Paint, Touch up (aerosol), Mushroom 1 $40.80

453567066161 Paint, Touch up (aerosol), Light Gray 1 $31.45

453567066171 Paint, Touch up (aerosol), Yellow 1 $33.15

453567066181 Paint, Touch up (aerosol), White 1 $35.70

453567066191 Paint, Touch up (aerosol), Silver 1 $35.70

453567066371 Footswitch Cover Assy 4 $1,336.20

453567543401 Laser Glasses fit over eye glasses 2 $1,074.40

453567080282 Power Supply Single Output 1 $2,620.55

453567080292 Power Supply, Triple Output 1 $2,965.65

451214872142 Xray Tube Cooling Unit 1 $16,830.00

989000085892 Xray Tube 1 $146,400.00

455011003081 U Type DMS With UHR 1 $160,936.45

453567412013 CIRS Vert. Server Dual Core 4 Drv, VSD4 V3 (old part # ended in 2011)

4 $62,281.20

453567135962 Extended Phantom Performance Kit (old part # 4535 671 35961)

4 $33,092.20

453567023021 ACQUISITOR PCB ASSY 1.1 GB 4 $69,693.20

453567056141 3 DBP, 6 ASIC 4 $71,981.40

455013000241 T7400 Intel Xeon X5450 3GHz Dual CPU (For EBW) for EBW only

4 $101,745.00

459801140821 LCD Display Monitor 19" 4 $10,665.80

455012310571 Data Cable for Perc Controller (Server) 8 $816.00

455013021061 Perc 6/I Internal Raid Controller Card (Server) 8 $9,152.80

453566503371 Detector Cable 12 $1,968.60

451213347481 Bucky Unit 2 Serial Cable 7 $1,219.75

989000070003 5-Field Amplimat Chamber 3 $16,988.10

451220106361 19"LCD Color Touchscreen 3 $6,895.20

451213357682 DELL Optiplex 960 + SW package + IfU (on DVD) 3 $26,512.35

989001084321 Barcode Reader 3 $1,009.80

451210045054 Low Voltage Power Supply (EZ102) 1 $2,675.80

451210497466 mA Control (EZ119) 1 $3,247.00

451210500053 KV Control (EZ130) 1 $2,088.45

451210518071 Central Unit (EZ139) 1 $2,084.20

451210812644 Universal I/O Interface (WA102) 1 $2,088.45

451210813864 CXA/ISO Interface Board (EZ) 1 $431.80

451217800204 Basic Interface (EZ150) 1 $1,156.85

242252601285 Lithium Battery 10 $374.00

989000002408 Operating Panel Opt. 1 $13,221.75

451210810421 PCB Bucky Controller (BuCo) 1 $2,512.60

451220103222 Firmware BuCo SW Rel. 9.2 4 $935.00

989000070005 5 Field Amplimat Chamber 1 $5,662.70

989001083761 Table top wide yellow 1 $5,049.00

989000086091 X-ray Tube SRO 2550 ROT 360 3 $29,534.10

451220102794 Frontcover VS/VM - 5 Field 1 $1,644.75

989601060151 X-ray Grid 140cm 10 $42,109.00

451211325509 BUF nCtl Software 2.3.2 (U20) 10 $212.50

451211432702 Firmware BuCo SW Rel. 14.4 4 $1,356.60

451213314992 Format Recognition PCB 1 $505.75

451213316632 Cable Routing Complete 1 $132.60

451213318343 Linearpoti Assy 1 $527.85

451213348833 BUF Contr SENs/Skyplate 04124-900-100 1 $1,728.05

451220102564 Bucky Unit 2 Sensing 3 $26,820.90

452212323702 Leaf Spring 1 $123.25

989001082341 IP Plate 14 X 17 24 $26,173.20

989001082361 IP Plate 8 X 10 33 $19,438.65

989001082381 IP Plate 10 X 12 51 $68,493.00

989001087021 CC CASS. 14X17 INCH LEADBACK 20 $14,280.00

989001087141 CC CASS: 10X12 INCH LEADBACK 33 $27,012.15

989001087161 CC CASS: 8X10 INCH LEADBACK 32 $46,756.80

242208610239 Fuse 10 $76.50

451210045231 Interface Relay 1 $152.15

451210438653 Cable Set Basic Version Optimus 1 $570.35

451210809042 PCB Amplimat Cable Adapter 1 $157.25

241252600162 Lithium Battery 20 $1,020.00

451210436805 Release Switch with Support 1 $627.30

451210501811 Set of Labels 1 $39.10

451210808145 PCB Desk Panel 1 $2,471.80

451220103431 Amplimat Display 1 $646.85

451213055562 Table Motion Control Board 1 $3,387.25

451213114102 Exposure release / sensing cable 1 $405.45

451213114152 Amplimat cable 1 $454.70

451220105832 Firmware BuCo SW Rel. 14.2 10 $1,598.00

452216700469 Bucky Controller Board with IC Chips 1 $4,492.25

989601060131 X-ray Grid 110cm 10 $41,973.00

242208601221 Fuse SB U-1 5X20 195I1-4 1 $7.65

242208610039 Fuse 1 $28.05

242254901668 Mains Filter B84113-C-830 1 $426.70

451210807388 Board UZ Field 1 $1008.95

451213114471 Connecting Cable UAN1X3/X4 - UZX14/UAC1000X3 1 $211.65

451213118041 Power Supply 12V DC / 24V DC 1 $1,688.10

451213187481 Magnetic Brake Assy 1 $1,280.95

451213303272 Sprocked Wheel Assy 1 $3,825.00

451220102344 Control Grip CS NICOL 1 $7,652.55

989601060141 X-ray Grid 180cm 10 $16,447.50

TOTAL $1,619,110.80

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

X (c) 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 Medical Systems is the manufacturer of the required repair parts identified in Table 1. Market Research revealed that Philips Medical Systems distributes the parts through authorized resellers. Therefore, brand name only repair parts will be purchased by the Government.

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: Three (3) authorized Philips Medical Systems resellers have been identified for the brand name repair parts required by USAMMA.

Specifically, the requiring activity identified (1) Allparts Medical (Philips Medical Systems is parent company) designated as a large business; (2) TQM, LLC dba Two Rivers Medical designated as a large business; and (3) PartsSource, Inc. designated as a small business. Additionally, in accordance with FAR subpart 5.2, a Notice of Intent of the proposed acquisition for Philips Medical Systems brand name repair parts will be posted to FedBizOpps on or about 20 August 2018. This Notice of Intent will allow for the submission of Capability Statements from other manufacturers or resellers that propose to have repair parts that can meet the Government’s need for brand name. Any responses received will be reviewed for the purpose of determining whether a full and open competition procurement is in the best interest of the Government.

a. Effective competition. As previously stated, market research has revealed there are three (3) authorized resellers capable of providing the required brand name Philips Medical Systems repair parts. Therefore, the Government intends to request quotes from the three (3) authorized resellers.

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 capable of meeting future requirements. 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 searches conducted by USAMMA on 13 July 2018 for this requirement on General Services Administration (GSA) Advantage! for the required brand name Philips Medical Systems repair parts included in Table 1.

This search revealed no results for the required brand name parts required including a review of Philips Medical Systems GSA contract for medical equipment and supplies.

USAMMA conducted additional market research on 13 July 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 Department of Defense (DoD) and VA business processes. The MPDB 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.

Federal Supply Schedule (FSS) / Blanket Purchase Agreement (BPA) / Distribution and Pricing Agreement (DAPA) / Electronic Catalog (ECAT)); 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: As previously stated, a Notice of Intent of the proposed brand name acquisition will be posted to FedBizOpps. This announcement will detail the Government’s intent to purchase the required items on a brand name only basis.

However, as market research efforts conducted for this procurement and stated elsewhere in this document revealed that there are three (3) authorized resellers, proposals will be requested via a Request for Proposal (RFP) posted to FedBizOpps to ensure effective competition. All proposals received in response to the RFP will be considered for contract award.

383345

12. Procurement History and any other facts:

Previous Contract or Purchase Order Number: A thorough search was conducted to include a review of USAMRAA’s contracting writing system, Procurement Desktop-Defense (PD2), the USAMRAA Paperless Acquisition System (UPAS), and the Virtual Contracting Enterprise Paperless Contract File (VCE-PCF). The search resulted in five (5) previous Purchase Orders issued for medical equipment repair parts manufactured by Philips. Table 2 identifies the prior Purchase Orders and acquisition information.

Table 2: Prior Repair Parts Awards

Purchase Order Date Award Amount Outcome JA Authority

W81XWH-16-P-0365 18 Sept 2016 $122,848.88 Competed – 3 quotes JA-16-180

FAR 13.106-1(b)(1)(i)

W81XWH-16-P-0390 19 Sept 2016 $117,848.34 1 Quote JA-16-297

FAR 13.106-1(b)(1)(i)

W81XWH-16-P-0417 15 August 2016 $1,705,869.08 1 Quote JA-16-184 FAR 13.501(a)(1)(i)

W81XWH-17-P-0160 30 May 2017 $68,741.84 1 Quote JA-17-146

FAR 13.106-1(b)(1)(i)

W81XWH-18-P-0073 21 May 2018 $654,631.40 Competed – 3 Quotes JA-18-98;

FAR 13.106-1(b)(1)(i)

Previously competed? Yes. Philips brand name repair parts was competed due to authorized resellers, reference Table 2.

Previous authority for less than Full and Open Competition: The following FAR authorities were cited for these previous Purchase Orders: FAR 13.106-1(b)(1)(i) and FAR 13.501(a)(1)(i) as referenced in Table 2.

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.

OLIPHANT.NEWT.III.1065 Digitally signed by

Submitted by Signature: OLIPHANT.NEWT.III.1065383345 Date: 2018.08.16 07:51:26 -04'00'

Printed name: Newt Oliphant III

Agency/Position/Title: Maintenance Procurement Officer, M3D, USAMMA

E-Mail

Date: 16 Aug 2018

STEPHENSO

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.

Contracting Officer Signature:

Digitally signed by

STEPHENSON.EVELY

Printed Name: Evelyn K. StephensNon.EVELYN.K.

Agency/Position/Title: Contracting1Off4ice5r,4US2AM4R3AA516 E-Mail

N.K.1454243516 Date: 2018.08.16

10:01:44 -04'00'

15. I hereby determine this SSJ to be Legally Sufficient.

Approval

Based on the foregoing justification, I hereby approve the procurement of the Brand Name Phillips Repair Parts in support of the U.S. Army Medical Materiel Agency (USAMMA) on an other than full and open competition basis pursuant to the authority of 41 U.S.C. 1901 or 41 U.S.C. 1903, as implemented by FAR subpart 13.106-1(b)(1), subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Date: Signature: