LSJ.pdf

General Services Administration (GSA) Federal Acquisition Service (FAS)

Southwest Supply Acquisition Center (SSAC) Brand Name Only - Limited Source Justification

Identification of the agency and the contracting activity

The Requiring Agency is the Naval Medical Logistics Command (NMLC), Fort Detrick, MD, on behalf of the Navy to meet fleet medical logistics requirements for and USNS MERCY (TAH-

19) and USNS COMFORT (TAH- 20). The contracting Activity is the General Services Administration, Global Supply, Southwest Supply Acquisition Center, 819 Taylor St., Fort Worth, TX 76102.

Nature and/or description of the action

This Limited Source Justification serves to support the brand name procurement of laboratory reagents on a Blanket Purchase Agreement (BPA) contract for products manufactured by Ortho- Clinical Diagnostics Inc, consisting of various laboratory reagents to support the Ortho Clinical analyzer onboard the United States Naval hospital ships USNS MERCY (TAH-19) and USNS

COMFORT (TAH- 20).

The acquisition will be a Firm Fixed Price contract on a GSA BPA procurement. This requirement is only available from various distributors of Ortho-Clinical Diagnostics, Inc. GSA will accept quotes from any vendor who is able to provide the specific brand name and part numbers listed in the requirement.

The BPA RFQ and approved LSJ will be posted on e-BUY under Schedule 66III, Clinical Analyzers, Laboratory, Cost-Per-Test, and Special Item Numbers (SINs) 605-1A, 605-2A and 605-6A.

This procurement is for one hundred-fifty-five (155) part numbers for various laboratory reagents required by the U.S. Navy. The U.S. Navy continues to have recurring and repetitive needs for the items, which are manufactured and supplied exclusively by Ortho-Clinical Diagnostics, Inc. The attached list of laboratory reagents will be required by the U.S. Navy.

IAW FAR 8.405-6(b), these items are peculiar to one manufacturer.

Description of Supplies Required

The USNS MERCY (TAH-19) and USNS COMFORT (TAH- 20) utilize the Ortho Clinical Diagnostics Vitros 4600 and ECI-Q Analyzers to perform the various laboratory tests. The hospital ships require various laboratory reagents in order to conduct laboratory tests. These specific reagents are mixed with the test samples in order to acquire the desired results. The Government intends on awarding a Firm Fixed Price BPA to any vendor who is able to provide the specific brand name and part numbers listed in the requirement.

The one hundred-fifty-five (155) part numbers will be solicited under a Blanket Purchase Agreement (BPA). The BPA duration will be through the end of Ortho-Clinical’s FSS Contract, not to exceed one base year with four-one year options. The estimated value for the five (5) year BPA is not to exceed $5,500,000.

Item No. Product Description UI

1 Ortho-Clinical Diagnostics, Inc. P/N 8262487 7% BSA 12/PK PKG 2 Ortho-Clinical Diagnostics, Inc. P/N 1037274 ACETAMINOPHEN 90/PK PKG 3 Ortho-Clinical Diagnostics, Inc. P/N 8196057 ALBUMIN 250/BX PKG 4 Ortho-Clinical Diagnostics, Inc. P/N 8046872 ALCOHOL 90 SLDS/PK PKG 5 Ortho-Clinical Diagnostics, Inc. P/N 1053180 ALK PHOSPHATASE 300/PK PKG 6 Ortho-Clinical Diagnostics, Inc. P/N 1655281 ALT 250/PK PKG 7 Ortho-Clinical Diagnostics, Inc. P/N 1726926 AMMONIA 90/PK PKG 8 Ortho-Clinical Diagnostics, Inc. P/N 1202670 AMYLASE 90 SLIDES/PK PKG 9 Ortho-Clinical Diagnostics, Inc. P/N AST Slides 300/BX PKG

10 Ortho-Clinical Diagnostics, Inc. P/N 718280 Bovine Albumin 22%, 15x10ml/PK PK 11 Ortho-Clinical Diagnostics, Inc. P/N 8383051 BUBC 300 SLIDES/PK PKG 12 Ortho-Clinical Diagnostics, Inc. P/N 8102204 BUN Slides 300/PK PKG 13 Ortho-Clinical Diagnostics, Inc. P/N 1882208 CAL KIT 1 4/BX PKG 14 Ortho-Clinical Diagnostics, Inc. P/N 6800189 CAL KIT 10 BOX/ 1 SET/ 6 BTLS BX 15 Ortho-Clinical Diagnostics, Inc. P/N 6801696 CAL KIT 11 BOX/ 1 SET/6BTLS BX 16 Ortho-Clinical Diagnostics, Inc. P/N 6801697 CAL KIT 12 BOX/1SET/6BTLS BX 17 Ortho-Clinical Diagnostics, Inc. P/N 6801698 CAL KIT 13 BOX/1 SET/ 6BTLS BX 18 Ortho-Clinical Diagnostics, Inc. P/N 6801699 CAL KIT 14 BOX/1 SET/6 BTLS BX 19 Ortho-Clinical Diagnostics, Inc. P/N 6801703 CAL KIT 19 PKG 20 Ortho-Clinical Diagnostics, Inc. P/N 1662659 CAL KIT 2 Vitros 250 4/BX PKG 21 Ortho-Clinical Diagnostics, Inc. P/N 6801896 CAL KIT 25 2/pk PKG 22 Ortho-Clinical Diagnostics, Inc. P/N 1290709 CAL KIT 3 4/PK PKG 23 Ortho-Clinical Diagnostics, Inc. P/N 1204668 CAL KIT 4 4/PK PKG 24 Ortho-Clinical Diagnostics, Inc. P/N 1149764 CAL KIT 5 (4/PK) PKG 25 Ortho-Clinical Diagnostics, Inc. P/N 8578163 CAL KIT 8 2SET/EA PKG 26 Ortho-Clinical Diagnostics, Inc. P/N 8568040 CAL KIT 9 2SET/PK PKG 27 Ortho-Clinical Diagnostics, Inc. P/N 1450261 CALCIUM 300/PK PKG 28 Ortho-Clinical Diagnostics, Inc. P/N 8445207 CHLORIDE Slides 300/PK PKG 29 Ortho-Clinical Diagnostics, Inc. P/N 1669829 CHOLESTEROL 300/BX PKG 30 Ortho-Clinical Diagnostics, Inc. P/N 8479396 CK 300/PK PKG

Ortho-Clinical Diagnostics, Inc. P/N 91474 CLINIQA LIQ QC CARDIAC MARKER CNTL

BOX /2 SETS

BX

32 Ortho-Clinical Diagnostics, Inc. P/N 6802584 CREATININE IDMS 5X60/BX PKG 33 Ortho-Clinical Diagnostics, Inc. P/N 1250232 DESICCANT PK 2ST/PK PKG 34 Ortho-Clinical Diagnostics, Inc. P/N 8343386 DIGOXIN 90 SLDS/PK PKG 35 Ortho-Clinical Diagnostics, Inc. P/N 6801895 DIRECT HDL 300/PK PKG 36 Ortho-Clinical Diagnostics, Inc. P/N 6801462 ECI ANTI HAV CALIBRATOR 1UL DS EA 37 Ortho-Clinical Diagnostics, Inc. P/N 6801463 ECI ANTI HAV CONTROL TOTAL 3/ DS EA 38 Ortho-Clinical Diagnostics, Inc. P/N 6801823 ECI ANTI HAV TOTAL RGT 100T DS EA 39 Ortho-Clinical Diagnostics, Inc. P/N 6801325 ECI ANTI-HCV (Ahcv) REAGENT EA 40 Ortho-Clinical Diagnostics, Inc. P/N 6801326 ECI ANTI-HCV CALIBRATOR EA 41 Ortho-Clinical Diagnostics, Inc. P/N 6801421 ECI ANTI-HCV CONTROL EA 42 Ortho-Clinical Diagnostics, Inc. P/N 1896836 ECI CKMB 100 wells BX 43 Ortho-Clinical Diagnostics, Inc. P/N 1286293 ECI CKMB CALIBRATOR BX/3 SETS BX 44 Ortho-Clinical Diagnostics, Inc. P/N 1728872 ECI FREE T4 CALIBRATORT BOX/ 3 SETS BX 45 Ortho-Clinical Diagnostics, Inc. P/N 1387000 ECI FREE T4 REAGENT 100T DS EA

Ortho-Clinical Diagnostics, Inc. P/N 1315654 ECI FREE THYROID CONTROL BOX/ 3

SETS

47 Ortho-Clinical Diagnostics, Inc. P/N 6801323 ECI HBSAG CALIB EA 48 Ortho-Clinical Diagnostics, Inc. P/N 6801390 ECI HBSAG CONTROL EA 49 Ortho-Clinical Diagnostics, Inc. P/N 6801322 ECI HBSAG REAGENT 100 DS EA 50 Ortho-Clinical Diagnostics, Inc. P/N 6801322 ECI HBSAG-CONFIRM KIT (HBCon) EA 51 Ortho-Clinical Diagnostics, Inc. P/N 1831312 ECI PACK MAINTENANCE BX 52 Ortho-Clinical Diagnostics, Inc. P/N 1009406 ECI RE (REP ENO) CONTROL BX/ 3sets BX 53 Ortho-Clinical Diagnostics, Inc. P/N 1072693 ECI SIGNAL REAGENT DS EA 54 Ortho-Clinical Diagnostics, Inc. P/N 1614965 ECI TOT T3 CALIBRATOR BOX/1 SET BX

Ortho-Clinical Diagnostics, Inc. P/N 1410646 ECI TOT THYROID CONTROL box/ 3 sets

56 Ortho-Clinical Diagnostics, Inc. P/N 6802220 ECI TOTAL B HCG RGT 100T DS EA 57 Ortho-Clinical Diagnostics, Inc. P/N 6802221 ECI TOTAL B-HCG CAL II BX/3 SETS BX 58 Ortho-Clinical Diagnostics, Inc. P/N 1322528 ECI TOTAL T3 REAGENT 100T DS EA 59 Ortho-Clinical Diagnostics, Inc. P/N 6802302 ECI TROPONIN I ES CALIBRATOR 1/ DS EA 60 Ortho-Clinical Diagnostics, Inc. P/N 6802301 ECI TROPONIN I ES RGT 100T DS EA 61 Ortho-Clinical Diagnostics, Inc. P/N 1487289 ECI TSH CALIBRATOR BOX/ 1SET BX 62 Ortho-Clinical Diagnostics, Inc. P/N 1912997 ECI TSH REAGENT 100T DS EA 63 Ortho-Clinical Diagnostics, Inc. P/N 8389793 ECI UNIVERSAL WASH REAGENT DS EA

Ortho-Clinical Diagnostics, Inc. P/N 6801060 ECI UNIVERSAL WASH RESERVOIR

FILTER

65 Ortho-Clinical Diagnostics, Inc. P/N 8262396 ECO2 Slides 300/PK PKG 66 Ortho-Clinical Diagnostics, Inc. P/N 8057812 REFERENCE FLUID 30 RESERVIOR/BOX BX 67 Ortho-Clinical Diagnostics, Inc. P/N 6801967 FS AIR FILTER 4 FILTERS BX 68 Ortho-Clinical Diagnostics, Inc. P/N 6801422 FS CUVETTES 6000 PKG

Ortho-Clinical Diagnostics, Inc. P/N 6801753 FS DILUENT PACK 2 (BSA/SALINE)

BOX/3 PACKS

Ortho-Clinical Diagnostics, Inc. P/N 6801754 FS DILUENT PACK 3 (SPECIALTY

DILUENT/WATER) BOX/ 3 PACKS

71 Ortho-Clinical Diagnostics, Inc. P/N 6801892 FS HUMIDIFICATION PK 6/BX PKG 72 Ortho-Clinical Diagnostics, Inc. P/N 6801423 FS MICRO TIPS 4096 TIPS PKG 73 Ortho-Clinical Diagnostics, Inc. P/N 6801711 GENTAMICIN REAGENT BOX 300T BX 74 Ortho-Clinical Diagnostics, Inc. P/N 8257289 GGT-50 PKG 75 Ortho-Clinical Diagnostics, Inc. P/N 1707801 GLUCOSE Slide 300/PK PKG 76 Ortho-Clinical Diagnostics, Inc. P/N 8430373 HI SAM DIL A (oN) 100 WLS BX 77 Ortho-Clinical Diagnostics, Inc. P/N 8321200 HI SAM DIL B (oN) 100 WLS BX 78 Ortho-Clinical Diagnostics, Inc. P/N 1830033 IMMUNOWASH FLUID BX 79 Ortho-Clinical Diagnostics, Inc. P/N 1924547 IRON 90/PK PKG 80 Ortho-Clinical Diagnostics, Inc. P/N 8150112 LACTATE 90SLIDES/PK PKG 81 Ortho-Clinical Diagnostics, Inc. P/N 8384489 LDH 250 SLIDES/PK PKG 82 Ortho-Clinical Diagnostics, Inc. P/N 8297749 LIPASE 90 SLDS/PK PKG

Ortho-Clinical Diagnostics, Inc. P/N 1384007 LIQUID PERFORMANCE VERIFIER 2

6/PK

PKG

Ortho-Clinical Diagnostics, Inc. P/N 8466492 LIQUID PERFORMANCE VERIFIER 1 6

BTL/PK

85 Ortho-Clinical Diagnostics, Inc. P/N 1632660 LITHIUM 90/PK PKG 86 Ortho-Clinical Diagnostics, Inc. P/N 8255093 MAGNESIUM 300 SLDS/PK PKG

87 Ortho-Clinical Diagnostics, Inc. P/N 1213115 MICRO SAMPLE CUPS BX 88 Ortho-Clinical Diagnostics, Inc. P/N 8067324 PERFORMANCE VERIFIER 1 12BT/PK PKG 89 Ortho-Clinical Diagnostics, Inc. P/N 8231474 PERFORMANCE VERRFIER 2 12SET/PK PKG 90 Ortho-Clinical Diagnostics, Inc. P/N 8221384 PHENOBARBITAL 5 PACK /90 SLDS BX 91 Ortho-Clinical Diagnostics, Inc. P/N 8298671 PHENYTONIN 5 PACK/90 SLDS BX 92 Ortho-Clinical Diagnostics, Inc. P/N 1513209 PHOSPHOROUS 300/PK PKG 93 Ortho-Clinical Diagnostics, Inc. P/N 8157596 POTASSIUM Slides 300/PK PKG 94 Ortho-Clinical Diagnostics, Inc. P/N 1314343 SALICYLATE 90/PK PKG 95 Ortho-Clinical Diagnostics, Inc. P/N 8379034 SODIUM 300/PK PKG 96 Ortho-Clinical Diagnostics, Inc. P/N 8559825 SPECIALTY DILUENT 6/BX BX 97 Ortho-Clinical Diagnostics, Inc. P/N 1877158 SYSTEM CLEANING SOLUTION BX

Ortho-Clinical Diagnostics, Inc. P/N 8962540 TDM 1 PERF VER (Shelf life 6 Months)(Frozen)

Ortho-Clinical Diagnostics, Inc. P/N 8182172 TDM 3 PERF VER 6/PK (Shelf life 6 Months)(Frozen)

100 Ortho-Clinical Diagnostics, Inc. P/N 1307164 THEOPHYLLINE 90/PK PKG 101 Ortho-Clinical Diagnostics, Inc. P/N 6801712 TOBRAMYCIN REAGENT BOX/300T BX 102 Ortho-Clinical Diagnostics, Inc. P/N 8159931 TOTAL BILIRUBIN 300/BX PKG 103 Ortho-Clinical Diagnostics, Inc. P/N 8392292 TOTAL PROTEIN 250/BX PKG 104 Ortho-Clinical Diagnostics, Inc. P/N 1336544 TRIGLYCERIDE300/BX PKG 105 Ortho-Clinical Diagnostics, Inc. P/N 6800190 UPRO PERF VERIFIER I BX/6 BTLS BX 106 Ortho-Clinical Diagnostics, Inc. P/N 6800191 UPRO PERF VERIFIER II BX/6 BTLS BX 107 Ortho-Clinical Diagnostics, Inc. P/N 1943927 URIC ACID 300/PK PKG 108 Ortho-Clinical Diagnostics, Inc. P/N 1110352 URINE ELECTROLYTE DILUENT 12/PK PKG 109 Ortho-Clinical Diagnostics, Inc. P/N 6800120 URINE PROT 90SL 5/PK PKG 110 Ortho-Clinical Diagnostics, Inc. P/N 6801710 VALPROIC REAGENT BOX/ 300T BX 111 Ortho-Clinical Diagnostics, Inc. P/N 6801709 VANCOMYCIN REAGENT BOX/ 300T BX 112 Ortho-Clinical Diagnostics, Inc. P/N 6801715 VITROS VERSA TIPS 1,000 TIPS PKG 113 Ortho-Clinical Diagnostics, Inc. P/N 1320498 CAL KIT 7 PKG 114 Ortho-Clinical Diagnostics, Inc. P/N 1074053 Cortisol Reagent PKG 115 Ortho-Clinical Diagnostics, Inc. P/N 1681543 Cortisol Calibrator BX 116 Ortho-Clinical Diagnostics, Inc. P/N 1927640 CRP Reagent PKG 117 Ortho-Clinical Diagnostics, Inc. P/N 8936049 CRP Performance Verifier 1 BX 118 Ortho-Clinical Diagnostics, Inc. P/N 8597452 CRP Performance Verifier 2 BX 119 Ortho-Clinical Diagnostics, Inc. P/N 6801428 ECI Anti-HBc Reagent EA 120 Ortho-Clinical Diagnostics, Inc. P/N 6801429 ECI Anti-HBc Calibrator EA 121 Ortho-Clinical Diagnostics, Inc. P/N 6801430 ECI Anti-HBc Control EA 122 Ortho-Clinical Diagnostics, Inc. P/N 6801925 ECI Anti-HBs Quant Reagent EA 123 Ortho-Clinical Diagnostics, Inc. P/N 6801926 ECI Anti-HBs Calibrator EA 124 Ortho-Clinical Diagnostics, Inc. P/N 6802093 ECI Anti-HBs Control EA 125 Ortho-Clinical Diagnostics, Inc. P/N 6801861 ECI Anti-HIV Reagent EA 126 Ortho-Clinical Diagnostics, Inc. P/N 6801862 ECI Anti-HIV Calibrator EA 127 Ortho-Clinical Diagnostics, Inc. P/N 6801863 ECI Anti-HIV Control EA 128 Ortho-Clinical Diagnostics, Inc. P/N 1315589 ECI Free T3 Reagent EA 129 Ortho-Clinical Diagnostics, Inc. P/N 1112820 ECI Free T3 Calibrator BX 130 Ortho-Clinical Diagnostics, Inc. P/N 8744468 ECI TOTAL T4 REAGENT EA 131 Ortho-Clinical Diagnostics, Inc. P/N 1393396 ECI TOTAL T4 Calibrator BX 132 Ortho-Clinical Diagnostics, Inc. P/N 6801728 LDL Reagent Pack PKG

133 Ortho-Clinical Diagnostics, Inc. P/N 1420025 Metabolism Control PKG 134 Ortho-Clinical Diagnostics, Inc. P/N 1849793 Prolactin Reagent PKG 135 Ortho-Clinical Diagnostics, Inc. P/N 113596 Prolactin Calibrator BX 136 Ortho-Clinical Diagnostics, Inc. P/N 6802001 TIBC Reagent PKG 137 Ortho-Clinical Diagnostics, Inc. P/N 6802348 TIBC Performance Verifier 1 PKG 138 Ortho-Clinical Diagnostics, Inc. P/N 6802349 TIBC Performance Verifier 2 PKG 139 Ortho-Clinical Diagnostics, Inc. P/N 6801709 VANCOMYCIN REAGENT BOX/ 300T BX 140 Ortho-Clinical Diagnostics, Inc. P/N 8221384 PHENOBARBITAL REAGENT TDM SLIDE BX 141 Ortho-Clinical Diagnostics, Inc. P/N 8298671 PHENYTONIN 5 PACK/90 SLDS BX 142 Ortho-Clinical Diagnostics, Inc. P/N 6801740 MICRO ALBUMIN REAGENT/300 PACK BX 143 Ortho-Clinical Diagnostics, Inc. P/N 6801746 mALB PV I BX 144 Ortho-Clinical Diagnostics, Inc. P/N 6801747 mALB PV II BX 145 Ortho-Clinical Diagnostics, Inc. P/N MA1361 Liquid mALB Control PKG 146 Ortho-Clinical Diagnostics, Inc. P/N 6801741 Pre Albumin Reagent 300/PACK BX 147 Ortho-Clinical Diagnostics, Inc. P/N 6801771 Pre Albumin Performance Verifier I BX 148 Ortho-Clinical Diagnostics, Inc. P/N 6801772 Pre Albumin Performance Verifier II BX 149 Ortho-Clinical Diagnostics, Inc. P/N 6801712 Tobramycin Reagent BX 150 Ortho-Clinical Diagnostics, Inc. P/N 8962540 TDM Performance Verifier I BX 151 Ortho-Clinical Diagnostics, Inc. P/N 1792357 TDM Performance Verifier II BX 152 Ortho-Clinical Diagnostics, Inc. P/N 8182172 TDM Performance Verifier III BX 153 Ortho-Clinical Diagnostics, Inc. P/N 8992382 (CRBM) Carbamazepin Reagent BX 154 Ortho-Clinical Diagnostics, Inc. P/N 8208431 CSF Protein 90 SLDS/PK BX 155 Ortho-Clinical Diagnostics, Inc. P/N 6802344 TIBC CAL KIT 29 BX

The products listed are the currently identified and U.S. Navy approved products necessary to accomplish the requiring activity’s mission. It is anticipated that products may be added to the list or modified as requirements change. Products that are approved to replace or supplement the items listed by the Navy Medical Logistics Command (NMLC), may be added at a later date.

Only those items that are approved by NMLC and fall within the scope of this BPA will be added.

Identification of the Statutory Authority

This acquisition is conducted under the authority of the Multiple Award Schedule (MAS) program. The primary statutory authorities for MAS are Title III of the Federal Property and Administrative Services Act of 1949 (41 USC 251 ET SEQ), and Title 40 U.S.C. 501, Services for Executive Agencies. The circumstances and rationale for limiting consideration to select schedule contractor for award follows: These items are also peculiar to one manufacturer as described in FAR 8.405-6(b).

This brand name only Justification will document that the items are essential to the Government’s requirements and the market research which indicates that no other manufacturer’s products meets – or can be modified to meet – the USNS Mercy’s and USNS Comfort’s requirements.

Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited

Background Information:

The Ortho Clinical Diagnostics Vitros 4600 and ECI-Q Analyzers are standard on US Navy Hospital Ships. Ortho-Clinical Diagnostics, Inc. is the sole manufacturer of the Ortho Clinical Diagnostics Vitros 4600 and ECI-Q Analyzers which are used to perform blood chemistry testing. The Ortho Clinical Diagnostics Vitros 4600 and ECI-Q are approved the Authorized Medical Allowance (AMAL) for all US Navy Hospital ships. The Navy spends considerable funds to support this equipment with the Integrated Logistics Support requirements such as tech manuals, preventive maintenance, and training for the onboard technicians. The requested specific reagents are the only reagents that can support lab tests with the Vitros 4600 and ECI-Q Analyzers. The reagents provided by Ortho Clinical Laboratories are the only reagent recognized by Ortho Clinical Laboratories for use on the Vitros 4600 and ECI-Q analyzers and is the only recognize reagents that the manufacture recommends to be used on these analyzers.

The effects of using any other reagents beside those supplies by Ortho Clinical Laboratories will require additional quality control testing to ensure they are compatible with the Vitros 4600 and ECI-Q Analyzers. Reliability of test results would be compromised by using untested and unverified reagents. Use of additional reagents would require additional funds for additional training, technical manuals and extra laboratory texting equipment. With limited space on the US Navy Hospital ships this would not support the mission and would not be cost effective for the US Navy. The US Navy Hospital ships must be mission ready at all times and ensure that they have the recommended reagents is a priority.

Determination that the anticipated Award will be the Best Value

A best value determination will be documented. Best value will be determined by comparison with similar products or as a matter of indirect pricing comparison. The Contracting Officer may seek out additional pricing data and recent history to substantiate price reasonableness.

This process will be repeated for any items that are added in the future that fall within the scope of the BPA and are designed to replace, update or supplement the items listed.

Prior to award, the Contracting Officer may seek additional price reductions from the awardee.

Market Research has shown the items attached in this procurement are available using a Federal Supply Schedule Contract awarded under the aforementioned Schedule and SINs. The Request for Quotation (RFQ) will be posted on GSA’s e-BUY program along with this Limited Source Justification (LSJ). Award will be made in the aggregate for all items.

DESCRIPTION OF THE MARKET RESEARCH CONDUCTED

Market research has determined, at this time that Ortho-Clinical Diagnostics, Inc. is the only manufacturer and distributor of the test items (reagents) requested. Ortho-Clinical Diagnostics, Inc. has a Federal Supply Schedule, V797D-60637. The Contract Specialist has identified two vendors who can supply the hardware (analyzers) to run the test, but do not supply the test items (reagents) at this time. GSA will accept quotes from any vendor who is able to provide the specific brand name and part numbers listed in the requirement and who has the part numbers listed on a Federal Supply Contract at the time of award.

OTHER FACTS SUPPORTING THE USE OF THE OTHER THAN FULL AND OPEN

COMPETITION

All factors are described under IDENTIFICATION OF STATUTORY AUTHORITY above.

STATEMENTS OF ACTION TO OVERCOME BARRIERS TO COMPETITION

This is a limited source procurement. Due to the proprietary nature of the reagents, Ortho- Clinical Diagnostics, Inc. is the only qualified manufacturer for the items. GSA will accept quotes from any vendor who is able to provide the specific brand name and part numbers listed in the requirement.

A Request for Quote (RFQ) will be posted in e-BUY and all vendors will be notified on the appropriate Schedule and SINs.

TECHNICAL/REQUIREMENTS CERTIFICATION

I certify that this supporting data under my cognizance, which form a basis for this justification, are accurate and complete to the best of my knowledge and belief. Technical Cognizance/Certification is from Mr. Noel A. Bondoc, at the Naval Medical Logistics Command, Fort Detrick, Frederick, MD.

4/24/2018

X Noel Bondoc

Noel Bondoc Supervisor, Procurement Signed by: BONDOC.NOEL.ANGELES.1187500440

24APR2018

Noel A. Bondoc Date Procurement Support Supervisor Operational Forces Directorate Naval Medical Logistics Command

CONTRACTING OFFICER CERTIFICATION

The Contract Officer has determined that the actions taken under this acquisition meet the conditions described in FAR 8.405-6 precludes competition to the maximum extent possible.

It is in the best interest of the Government to purchase various laboratory reagents to support the Vitros 4600 and ECI-Q Analyzers from any vendor who is able to provide the specific brand name and part numbers listed in the requirement.

The information contained in this justification is accurate and complete to the best of the Contracting Officer’s knowledge and belief.

Prepared By:

Martin D. Cieszlak Date Contracting Specialist (7QSBAAC-M4)

Reviewed By:

Denise Robinson Date Contracting Officer (7QSBAAC)

Approvals:

Lindsay Wong (7QSBAA) Date Branch Chief/Contracting Officer

Jil LaDuca Date Director, Southwest Supply Acquisition Center (7QSB)

Amy Cook Date Assistant Regional Counsel (7L)

Shaloy Castle-Higgins Date Competition Advocate (7QSC)