36C25018D0052-010.pdf

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PRIORITY:

REQUISITION NUMBER:

REQUEST, TURN- IN, AND RECEIPT FOR PROPERTY OR SERVICES

TO: A&MM OFFICER Requesting Office TO BE COMPLETED BY

SUPPLY PERSONNEL

Action Requested

Delivery

Date Prepared Date Required

ITEM NO. DESCRIPTION

See SCHEDULE/DELIVERY Files

QUANTITY UNIT ESTIMATED UNIT COST TOTAL COST ACT.

OR STOCK NO. UNIT COST NOTE1

VENDOR INFORMATION: NO.

VENDOR:

CONTACT:

PHONE:

ACCT#:

DUNS:

DUNS+4:

Ref. Voucher Number:

SPECIAL REMARKS: See Special Remarks Attachment

DELIVER TO:

FOB TERMS DELIVERY DATE QUOTE DATE BY (Initials)

JUSTIFICATION OF NEED OR TURN-IN (If recurring need, indicate 30 day estimate. If turn-in, do not use this form if circumstances require use of VA Form 90-1217, Report of Survey)

See Justification of Need Attachment

Originator of Request:

Signature of Initiator

Approving Official:

/ES/

Date

VA FORM 90-2237ADP MAR 1985

SPECIAL

541-18-1-775-0001

06-02-2017 10-01-2018

100039

CEPHEID

904 CARIBBEAN DRIVE

SUNNYDALE CA 94089

956711444

KAMRAM SYED

888 838 3222 1000000787

TRACIE ELLIS-REID

SUPERVISOR

EVELYN CRAW

MANAGEMENT ASSISTANT

SPECIAL REMARKS

INDEFINITE QUANTITY, INDEFINITE DELIVERY. NOTIFICATION WILL BE GIVEN 2>TO

VENDOR FOR DELIVERY AS INVENTORY IS NEEDED 3>TO ESTABLISH A BASE PLUS

FOUR YEAR CONTRACT 4>REFERENCE QUOTE #2022222 FROM CEPHEID

JUSTIFICATION OF NEED

NEEDED FOR VARIOUS MOLECULAR TESTS ON VA PATIENTS INCLUDING MRSA, CDIFF

STD, SCREEN FOR GENETIC MUTATIO AND FLU TESTING

A.1 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 KIT,CDIFF/EPI,GX,IVD,120-

TEST IMF# 49505

LOCAL STOCK NUMBER:

GXCDIFF/EPI-120

18.00 EA $2,880.0000 $51,840.00

Funding/Req. Number: 1 $51,840.00 541-18-1-775-0001

0002 XPERT CT/NG-120 US-IVD

IMF# 49506

GXCT/NG-120

24.00 EA $3,625.0000 $87,000.00

Funding/Req. Number: 1 $87,000.00 541-18-1-775-0001

0003 KIT, FII/FV, 10-TESTS,

GX,IVD IMF# 30907

GXFIIFV-10

26.00 EA $477.0000 $12,402.00

Funding/Req. Number: 1 $12,402.00 541-18-1-775-0001

0004 GENEXPERT MRSA 120

TEST KIT IVD IMF# 49507

GXMRSA-120

70.00 EA $3,815.9900 $267,119.30

Funding/Req. Number: 1 $267,119.30 541-18-1-775-0001

0005 KITXPRESS,FLU,US-

IVD,10 IMF# 53517

XPRSFLU-10

46.00 EA $397.5000 $18,285.00

Funding/Req. Number: 1 $18,285.00 541-18-1-775-0001

GRAND

TOTAL

$436,646.30

ACCOUNTING AND APPROPRIATION DATA

ACRN APPROPRIATION

REQUISITION

NUMBER AMOUNT

1 541-3680160-775-822300 Laboratory- 2632 Other Medical and Dental- 0100J20P5

541-18-1-775-0001 (P) $436,646.30

A.2 DELIVERY SCHEDULE

ITEM NUMBER QUANTITY

DELIVERY

DATE

0001 18.00

0002 24.00

0003 26.00

0004 70.00

0005 46.00

Item # Description/Part Number*

Qty Price

1 Base year Reagent test kits 1 436,646.30$ 2 Option year 1 Reagent Kits 1 458,478.61$ 3 Option year 2 Reagent Kits 1 481,402.54$ 4 Option year 3 Reagent Kits 1 505,472.67$ 5 Option year 4 Reagent Kits 1 530,746.30$

SUBTOTAL (Products)

SUBTOTAL (Services)

Engineering Estimates

Brief Description of Service*

Products (including software, licenses)

Services

Period of Performance

TOTAL IGCE

Prior Monthly Vouchers Catalog Pricing Other (Please Explain ):

INDEPENDENT GOVERNMENT COST ESTIMATE (IGCE)

*Check block(s) below that describe the basis for the IGCE:

Past Contract Pricing GSA Federal Supply Schedule Published Prices Government Wide Acquisition Contract (GWAC) Published

Phone: 216-791-380 Date: 9/4/2017

POC NAME: Evelyn Craw Email: Evelyn.craw@va.gov

Informal Vendor Quotes Prior Bills of Material

Extended Amount 436,646.30$ 458,478.61$ 481,402.54$ 505,472.67$ 530,746.30$

2,412,746.42$

Estimated Amount

2,412,746.42$

00 x2258

Attachment 3—Market Research Report Template

Acquisition Planning SOP Page 1 of 6 Revision: 03, Effective Date: 01/30/17

Market Research Report Note: This template is not required to be uploaded into eCMS for actions under $1M. However, COs must ensure supporting documentation is uploaded to support a decision not to set-aside an action for SDVOSB/VOSB.

Date: November 3, 2017

Purchase Request/2237 Number: 541-18-1-775-0001

Description of requirement: Cepheid Reagents Cleveland

Period of Performance: December 22, 2017-December 21, 2022

Estimated Value: $2,183,231.50

Product Service Code (PSC) -

Federal Supply Codes (FSC):

NAICS Code: 334516

Size Standard for NAICS: 1,000

Market Research Findings:

Per PPM 2016-05 Implementation of the Veterans First Contracting Program as a Result of the

U.S. Supreme Court Decision: 38 U.S.C. § 8127 is mandatory, not discretionary and its text requires the Department to apply the Rule of Two to all contracting determinations; The Rule of Two contracting procedures in 38 U.S.C. § 8127(d) are not limited to those contracts necessary to fulfill the Secretary’s goals under § 8127(a); and 38 U.S.C. § 8127(d) applies to orders placed against the

Federal Supply Schedules (FSS).

Supplies (Mandatory IAW FAR 8.002):

Results from Market

Research:

(1) VA inventories including the VA supply stock program (41 CFR

101-26.704) and VA excess:

Not Available

(2) Excess from other agencies (FAR 8.002): Not Available

(3) *Federal Prison Industries (FPI) (See VAAR 808.603 Purchase

Priorities)

*VA COs may purchase supplies and services produced or provided by FPI from eligible service disabled veteran-owned small businesses and veteran-owned small businesses, in accordance with procedures set forth in subpart

819.70, without seeking a waiver from FPI, in accordance with

38 U.S.C. 8128, Small business concerns owned and controlled by veterans: Contracting priority

(4) Supplies from Ability One - (VA AbilityOne Procurement List for Supplies/Services) (FAR 8.002):

However, VA COs shall, prior to adding any new VA requirements to the Procurement List, conduct market research, apply the VA Rule of Two to consider Vendor

Information Pages (VIP) verified service-disabled veteran-owned small businesses (SDVOSBs) and veteran-owned small businesses (VOSBs) as required in 38 U.S.C. 8127 and implemented in subpart 819.70.

(5) Wholesale supply sources such as stock programs of the GSA

(see 41 CFR 101-26.3), the Defense Logistics Agency (see 41

CFR 101-26.6), the Department of Veterans Affairs (see 41 CFR

101-26.704 (VA Subsistence Items), and military inventory control points.

http://support.outreachsystems.com/resources/tables/pscs/ http://support.outreachsystems.com/resources/tables/pscs/ http://www.census.gov/eos/www/naics/ https://www.sba.gov/sites/default/files/files/Size_Standards_Table.pdf http://www.va.gov/oal/docs/business/pps/ppm201605.pdf http://www.va.gov/oal/docs/business/pps/ppm201605.pdf https://www.acquisition.gov/?q=/browse/far/8 https://www.gpo.gov/fdsys/pkg/CFR-2015-title41-vol2/pdf/CFR-2015-title41-vol2-sec101-26-704.pdf https://www.gpo.gov/fdsys/pkg/CFR-2015-title41-vol2/pdf/CFR-2015-title41-vol2-sec101-26-704.pdf https://www.acquisition.gov/?q=/browse/far/8 http://www.va.gov/oal/library/vaar/vaar808.asp http://www.va.gov/oal/library/vaar/vaar808.asp http://www.va.gov/oal/library/vaar/vaar819.asp http://www.abilityone.com/OA_HTML/ibeCZzpHome.jsp?minisite=10040&respid=22372&grp=IBE_M_OTHER http://www.abilityone.gov/procurement_list/index.html http://www.abilityone.gov/procurement_list/index.html https://www.acquisition.gov/?q=/browse/far/8 https://www.vip.vetbiz.gov/ https://www.vip.vetbiz.gov/ http://www.va.gov/oal/library/vaar/vaar819.asp https://www.gsaglobalsupply.gsa.gov/advantage/main/start_page.do?store=FSS http://www.va.gov/oal/business/nc/spv.asp

Acquisition Planning SOP Page 2 of 6

(6) Prime Vendor and National Contracts/BPAs: Reference CPL&O

Memo dated 23Aug16, Subj: Mandatory Use of Prime

Vendor Distribution Contracts and National Contracts): It is VHA's policy that any item(s) that is/are available in prime vendor formularies/catalogs, it is mandatory in VHA that any such item(s) will be “ordered”/acquired through the prime vendor. It is also VHA’s policy that items available on national contracts/BPAs that are not available via prime vendor distribution networks will be acquired by placing appropriate orders against these national contracts. Such orders will only be placed by properly warranted COs or properly trained

Ordering Officers appointed by the appropriate CO. In cases where an Ordering Officer has been appointed, orders placed are not competitive contracting actions subject to the requirements of 38 U.S.C. 8127. In cases where OO appointments are NOT available, the appropriate CO must make a determination as to whether the Rule of Two applies (see the Decision Tree Tool to assist with the determination).

Services (Mandatory IAW FAR 8.002):

(1) Services that are on the Procurement List maintained by the

Committee for Purchase From People Who Are Blind or Severely

Disabled (see subpart 8.7). Note: VA COs shall, prior to adding any new VA requirements to the Procurement List, conduct market research, apply the VA Rule of Two to consider VIP verified

SDVOSBs) and VOSBs as required in 38 U.S.C. 8127 and implemented in subpart 819.70.

(2) Unusual and compelling urgency. The contracting officer may use a source lower in priority than as specified in 808.002-70 when the need for supplies or services is of an unusual and compelling urgency (see FAR Subpart 6.302-2 and FAR Subpart 8.405-6).

Use of Other Mandatory Sources (FAR 8.003):

Agencies shall satisfy requirements for the following supplies or services from or through specified sources, as applicable:

(a) Public utility services (see part 41).

(b) Printing and related supplies (see subpart 8.8).

(c) Leased motor vehicles (see subpart 8.11).

(d) Strategic and critical materials (e.g., metals and ores) from inventories exceeding Defense National Stockpile requirements

(detailed information is available from the DLA Strategic

Materials, 8725 John J. Kingman Rd., Suite 3229, Fort Belvoir, VA

22060-6223.

(e) Helium (see subpart 8.5 -- Acquisition of Helium).

Mandatory Sources for VA Ref. 38 U.S.C. 8127 and 8128:

Search the Vendor Information Pages (VIP) database at https://www.vip.vetbiz.gov/ and document their findings to ensure

Does the CO have a reasonable expectation that two or more http://www.va.gov/officeofacquisitionoperations/sac/mspvLegacy.asp http://vaww.pclo.infoshare.va.gov/PCLO/MMStrategicPlan/PEO/Lists/National%20ContractBPABOA/AllItems.aspx http://vaww.pclo.infoshare.va.gov/PCLO/MMStrategicPlan/LogPolicySite/Lists/Log_Policy_List/Attachments/124/2016-08-23-VHA-Memo-10NA2-Mandatory-Use-of-Prime-Vendor-Distribution-Contracts-and%20National-Contracts.pdf http://vaww.pclo.infoshare.va.gov/PCLO/MMStrategicPlan/LogPolicySite/Lists/Log_Policy_List/Attachments/124/2016-08-23-VHA-Memo-10NA2-Mandatory-Use-of-Prime-Vendor-Distribution-Contracts-and%20National-Contracts.pdf http://vaww.pclo.infoshare.va.gov/PCLO/MMStrategicPlan/LogPolicySite/Lists/Log_Policy_List/Attachments/124/2016-08-23-VHA-Memo-10NA2-Mandatory-Use-of-Prime-Vendor-Distribution-Contracts-and%20National-Contracts.pdf http://www.va.gov/oal/docs/business/pps/flash16-20att3.pdf https://www.acquisition.gov/?q=/browse/far/8 http://www.abilityone.gov/procurement_list/index.html https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%208_7.html#wp1103480 https://www.vip.vetbiz.gov/ http://www.va.gov/oal/library/vaar/vaar819.asp http://www.va.gov/oal/library/vaar/vaar808.asp https://www.acquisition.gov/?q=/browse/far/6 https://www.acquisition.gov/?q=/browse/far/8 https://www.acquisition.gov/?q=/browse/far/8 https://www.acquisition.gov/?q=/browse/far/41 https://www.acquisition.gov/?q=/browse/far/8 https://www.acquisition.gov/?q=/browse/far/8 https://www.acquisition.gov/?q=/browse/far/8 https://www.vip.vetbiz.gov/

Acquisition Planning SOP Page 3 of 6 compliance with 38 U.S.C. 8127’s “Rule of Two.” VA must set aside procurements for VOSBs when market research determines that two or more VOSBs are able to meet the procurement requirements at a fair and reasonable price that offers the best value to the United States. NOTE: A determination of price fair and reasonableness does not have to be done during market research phase BUT is required prior to contract award.

NOTE: In the paragraph above, “VOSBs” includes

SDVOSBs. If market research reveals there are one

SDVOSB and one VOSB, the action should be set aside for

VOSB because a SDVOSB is also a VOSB.

✓ Conduct Market Research by NAICS in VIP

✓ Verify Companies are VOSBs for Size Standard for

NAICS in the System for Award Management (SAM)

“Reps and Certs”

✓ Verify in VIP

✓ SDVOSB or VOSB set-aside is subject to the Limitations on Subcontracting clauses—VAAR 852.219-10. Any

SDVOSB or VOSB that proposes to furnish an end product it did not manufacture (a “nonmanufacturer”) must meet the requirements in FAR 19.102(f) to receive a benefit under the Veterans First Contracting

Program.

verified SDVOSBs/VOSBs in

VIP is capable of providing the item will submit offers, and that the award can be made at a fair and reasonable price that offers the best value to the

United States?

Yes, action can be set-aside—two or more eligible SDVOSB/VOSBs can provide item(s) at reasonable price

No, there are NOT two or more eligible VOSBs that can provide the items.

COs should attach supporting documentation

(excel spreadsheet with

VIP search results or screen shots with search results) under (P02)

808.004-70 Use of Non-Mandatory Sources by VA.

(1) IDIQ Contracts awarded by VISN, Region, or Local VA

Contracting Officers for FSC Groups 65 and 66.

✓ If two or more verified SDVOSBs/VOSBs in VIP is on the VISN/Regional/Local IDIQ contracts, use competitive set-aside procedures

(2) GSA FSS and Pre-Existing Contracts, including Interagency and

Intra-agency Contracts.

the GSA FSS/Pre-Existing Contracts including IAs, use competitive set-aside procedures

(3) Open Market Purchases, including Educational and Non-Profit

Institutions.

the open market, including educational/non-profit contracts, use competitive set-aside procedures

Available http://www.census.gov/eos/www/naics/ https://www.sba.gov/sites/default/files/files/Size_Standards_Table.pdf https://www.sba.gov/sites/default/files/files/Size_Standards_Table.pdf https://www.sam.gov/portal/SAM/?portal:componentId=9c7c412d-0e75-4bfd-8223-f425559b9408&interactionstate=JBPNS_rO0ABXc0ABBfanNmQnJpZGdlVmlld0lkAAAAAQATL2pzZi9uYXZpZ2F0aW9uLmpzcAAHX19FT0ZfXw**&portal:type=action#1 https://www.vip.vetbiz.gov/ http://www.va.gov/oal/library/vaar/vaar852.asp#85221910 https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%2019_1.html#wp1101837

Acquisition Planning SOP Page 4 of 6

(4) Eligible Beneficiaries:

1) A CO may authorize an acquisition from the Veterans

Canteen Service or a commercial source when a VA healthcare official (e.g., social worker, physician) determines that personal selection of shoes, clothing, and incidentals will result in a therapeutic benefit to an eligible beneficiary.

2) The CO must cite FPI, Inc., clearance No. 1206 in the purchase document for any purchase of dress shoes from the

Veterans Canteen Service or a commercial source similar to

FPI, Inc., Style No. 86-A.

Not Applicable

(5) Three contracts for desktops and laptops have been established as mandatory:

a. NASA Solutions for Enterprise-Wide Procurement (SEWP)

b. GSA IT Schedule 70

c. National Institutes of Health Information Technology

Acquisition and Assessment Center Chief Information

Officer – Commodities and Solutions (CIO-CS)

✓ If two or more verified SDVOSBs/VOSBs in VIP is on the

SEWP, GSA IT Schedule 70 contracts or others in this category, use competitive set-aside procedures

Not Applicable

Use of Other Sources (FAR 8.004) Results from Market Research:

If an agency is unable to satisfy requirements for supplies and services from the mandatory sources listed in 8.002 and 8.003, agencies are encouraged to consider satisfying requirements from or through the non-mandatory sources listed in paragraph

(a) of this section (not listed in any order of priority) before considering the non-mandatory source listed in paragraph (b) of this section. When satisfying requirements from non-mandatory sources, see 7.105(b) and part 19 regarding consideration of small business, veteran-owned small business, service-disabled veteran-owned small business, HUBZone small business, small disadvantaged business (including 8(a) participants), and women-owned small business concerns (see VAAR 819.7004). VA COs must comply with PPM 2016-05 Implementation of the Veterans

First Contracting Program as a Result of the U.S. Supreme

Court Decision.

(a)(1) Supplies. Federal Supply Schedules, Governmentwide acquisition contracts, multi-agency contracts, and any other procurement instruments intended for use by multiple agencies, including blanket purchase agreements (BPAs) under Federal Supply Schedule contracts (e.g., Federal

Strategic Sourcing Initiative (FSSI) agreements accessible at http://www.gsa.gov/fssi (see also 5.601)).

(2) Services. Agencies are encouraged to consider Federal

Prison Industries, Inc., as well as the sources listed in paragraph (a)(1) of this section (see subpart 8.6).

(b) Commercial sources (including educational and non-profit institutions) in the open market.

http://www.sewp.nasa.gov/index.shtml http://www.gsa.gov/portal/content/104506 https://nitaac.nih.gov/ https://www.acquisition.gov/?q=/browse/far/8 https://www.acquisition.gov/?q=/browse/far/8 https://www.acquisition.gov/?q=/browse/far/7 https://www.acquisition.gov/?q=/browse/far/19 http://www.va.gov/oal/library/vaar/vaar819.asp http://www.va.gov/oal/docs/business/pps/ppm201605.pdf http://www.va.gov/oal/docs/business/pps/ppm201605.pdf http://www.va.gov/oal/docs/business/pps/ppm201605.pdf http://www.gsa.gov/fssi https://www.acquisition.gov/?q=/browse/far/5 https://www.acquisition.gov/?q=/browse/far/8

Acquisition Planning SOP Page 5 of 6 any of the categories above, use competitive set-aside procedures

Customary Commercial Terms and Conditions:

1. Per FAR 10.002, market research is conducted to determine if commercial items or nondevelopmental items are available to meet the Government’s needs or could be modified to meet the Government’s needs.

Information specific to the item being acquired, including but not limited to:

a. Whether the Government’s needs can be met by –

(1) Items of a type customarily available in the commercial marketplace:

The Cepheid reagents are available in the commercial marketplace.

b. Customary practices regarding customizing, modifying or tailoring of items to meet customer needs and associated costs:

Customary practices regarding customizing, modifying or tailoring of items to meet customer needs and associated will be used.

c. Customary practices, including warranty, buyer financing, discounts, contract type considering the nature and risk associated with the requirement, etc., under which commercial sales of the products are made:

Customary practices, including warranty, buyer financing, discounts, contract type considering the nature and risk associated with the requirement, etc., under which commercial sales of the products are made will be used.

d. The requirements of any laws and regulations unique to the item being acquired:

The requirements of any laws and regulations unique to the item being acquired will be used.

e. The availability of items that contain recovered materials and items that are energy efficient:

N/A

f. Results from VIP--are there two or more verified SDVOSB/VOSBs that are able to meet the procurement requirements?

https://www.acquisition.gov/?q=/browse/far/10

Acquisition Planning SOP Page 6 of 6

There are not two or more verified SDVOSB/VOSBs that are able to meet the procurement requirements.

Summary of Market Research Results:

2. MARKET PRICE: $2,412,746.43

3. ACQUISITION HISTORY:

VA541P79344, awarded on 06/26/2017 in the amount of $3,180.00 for Microbiology Analyzer Kit.

VA541P79089, awarded on 06/16/2017 in the amount of $3.021.00 for Infectious Disease Testing Kit.

VA541P78793, awarded on 06/09/2017 in the amount of $3,180.00 for Microbiology Analyzer Kit.

VA541P78624, awarded on 06/05/2017 in the amount of $3,166.77 for Microbiology Analyzer Kit.

VA541P78622, awarded on 06/05/2017 in the amount of $3,054.83 for Infectious Disease Testing Kit.

4. OTHER PERTINENT INFORMATION:

A Sources Sought was posted on FBO from October 4, 2017 through October 18, 2017 with two responses. The responses were from two (2) Service Disabled Veteran Owned

Small Business (SDVOSB); Orion Services, Inc., and Veterans Healthcare Supply

Solutions (VHSS). Both Contractors do not have authorized distributor letters, and are not authorized by Cepheid to distribute to the VA. Cepheid does not have distributors for VA, at this time.

An Intent to Sole Source, 36C25018Q0060, was posted on FBO from October 20, 2017 through November 2, 2017 with no responses.

5. RECOMMENDATION:

• Contract Approach: Firm Fixed Price

• Level of Competition: OM/Base + 4 Intent to Sole Source

Program Office Point of Contact:

Name: Evelyn Craw

Phone: 216-791-3800 x2258

Prepared by: Rachelle J. Hamer

Name: Date: 11/21/2017

Gina P. Crank, Contracting Officer

2017-11-21T16:27:17-0500

Gina P. Crank 209604

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >$150K

OFOC SOP Revision 06 Page 1 of 5 Original Date: 03/22/11 Revision 06 Date: 08/30/2017

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>$150K)

Acquisition Plan Action ID: VA250-17-AP-14409

1. Contracting Activity: The Department of Veterans Affairs (VA), VISN 10, Louis Stokes

Cleveland Veterans Affairs Medical Center (CLE VAMC), Pathology and Laboratory Medicine Service (PLMS), has a request for Cepheid reagents, test kits, and materials for their GeneXpert equipment.

Transaction: 541-18-1-775-0001

2. Nature and/or Description of the Action Being Processed: Network Contract Office (NCO) 10 intends to award a new, firm fixed price, Indefinite Delivery, Indefinite Quantity, base plus four (4) option years contract to Cepheid. The request is for reagents, test kits, and materials for the PLMS GeneXpert equipment. Cepheid reagents, test kits, and materials are needed for various molecular tests on CLE VAMC patients including MRSA, CDIFF, STD Screen and Flu testing. This procurement is in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501, Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

(a) Description of Supplies:

Cepheid reagents, test kits, and materials are needed for various molecular tests on CLE VAMC patients including MRSA, CDIFF, STD Screen and Flu testing.

Description Total Quantity

CDIFF/EPI KIT GX.IVD

16 Boxes of 120 Count

GENEXPERT CT/NG KIT

22 boxes of 120 Count

XPERT FII & FV CONNBINED KIT 25 boxes of 10 Count

XPERT MRSA KIT

67 boxes of 120 Count

GENEXPERT FLU KIT

46 boxes of 10 Count

OFOC SOP Revision 06 Page 2 of 5

(b) ESTIMATED DOLLAR VALUE: $436,646.30 for the base year and $2,412,746.42 with four (4) option years.

(c) REQUIRED DELIVERY DATE: December 22, 2017-December 21, 2018

4. Statutory Authority Permitting Other than Full and Open Competition:

( ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per FAR 6.302-3;

( ) (4) International Agreement per FAR 6.302-4 ( ) (5) Authorized or Required by Statute FAR 6.302-5;

( ) (6) National Security per FAR 6.302-6;

( ) (7) Public Interest per FAR 6.302-7;

FAR 13.5 Simplified Procedures for Certain Commercial Items:

The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(2).

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Cepheid is uniquely qualified to provide the reagents, test kits, and materials based on the following:

Cepheid is the only source that can provide the specific reagents, test kits, and materials for the GeneXpert equipment currently in use by the PLMS at the CLE VAMC to perform C.

difficile, N. gonorrhoeae, and C. trachomatis testing. The reagents are specific to the equipment used and alternate vendors cannot provide acceptable reagent systems. The reagents are only available through Cepheid. The vendor was selected based on the availability of the reagents that meet the specific parameters of the equipment (chemical and antibody make-up, configuration, size, shape, etc.). This ensures that the highest standard of accuracy and validation is maintained, as required by the Collage of American

Pathologists (CAP) and The Joint Commission (TJC). This presents a compelling need to continue this procurement with Cepheid.

• The reagents, test kits, and materials are proprietary to Cepheid;

• Cepheid has no VA distributors for the reagents, test kits, and materials;

• The GeneXpert is only compatible with Cepheid cartridges, in which currently the service uses;

OFOC SOP Revision 06 Page 3 of 5

• The sample process is fully automated and integrated with an automated real-time PCR system;

• The equipment, reagents, test kits, and materials, contributes to ease of use, productivity, reproducibility and reduced turn-around time;

• The simplicity and ease of use of this system for true employability and sustainability;

• Batching is not required to achieve either operational efficiency or cost savings;

• Allows true 24/7 results;

• Random access capability;

• Closed system;

• Does not require separately processed controls with each run; and

• Utilizes primarily freeze dried reagent technology vs. liquid reagents; and LIS capability.

Accordingly, Cepheid is the only firm capable of providing the supplies described in Section three (3) above without the Veteran’s Health Administration experiencing substantial duplication of cost that could not be expected to be recovered through competition.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A Sources Sought was posted on FBO from October 4, 2017 through October 18, 2017 with two responses. The responses were from two (2) Service Disabled Veteran Owned Small Businesses (SDVOSB); Orion Services, Inc., and Veterans Healthcare Supply Solutions (VHSS). Both Contractors do not have authorized distributor letters, and are not authorized by Cepheid to distribute to the VA. Cepheid does not have distributors for VA, at this time.

An Intent to Sole Source, 36C25018Q0060, was posted on FBO from October 20, 2017 through November 2, 2017 with no responses.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable: The offeror will be evaluated In accordance with (IAW) FAR 13.106-2, the quotation will be evaluated for the following factors: Price and Past Performance. A determination of price fairness and reasonableness will be determined IAW FAR Part 13.106-3(2)(ii) and FAR Part 13.106-3(2)(iii), a comparison of proposed price with prices found reasonable on previous purchases and current price lists.

OFOC SOP Revision 06 Page 4 of 5

8. Description of the Market Research Conducted and the Results, or a Statement of the

Reasons Market Research Was Not Conducted: Market research was conducted by the Contracting Officer and the PLMS to identify available sources to meet the requirements as follows:

FSS, GSA, FBO, Vetbiz and the internet were reviewed with no results. Based on the results of market research, the Government determined that there is only one contractor, Cepheid, that can provide the reagents, test kits, and materials necessary for patient care. There are no SDVOSB’s at this time to distribute the supplies needed, at this time.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: N/A

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: A Sources Sought was issued on FedBizOpps on October 4, 2017 through October 18, 2017, requesting that parties express their interest in writing.

Orion Services, Inc.

65 Aspen Lake Dr. East Newnan, GA 30263 Phone: 510-766-6671 Email: david.diaz@orionservicesinc.com

Veterans Healthcare Supply Solutions 13949 Alvarez Road, Suite 300 Jacksonville, FL 32218 Phone: 904-638-5519 Email: gpierc@vhss1.com

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: Due to the technical risks, compatibility requirements of the existing equipment, and proprietary rights of Cepheid, there are no ways to eliminate the restriction of this requirement. If a future requirement for the same solution is identified, a full and open competition after exclusion of sources, shall be promoted amongst Cepheid resellers if there are subsequent acquisitions.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and 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.

mailto:david.diaz@orionservicesinc.com mailto:gpierc@vhss1.com

OFOC SOP Revision 06 Page 5 of 5

Kristine A. Dixon Date Pathology and Laboratory Medicine Service (PLMS)V VISN 10 Louis Stokes Cleveland VA Medical Center

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Gina P. Crank Date Contracting Officer Network Contracting Office (NCO) 10

b. One Level Above the Contracting Officer (Required over$150K but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

Terry L. Spitzmiller Date Director of Contracting Network Contracting Office (NCO) 10

c. VHA SAO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and recommend approval (if over $68 million) or approve ($700K to $68 million) for other than full and open competition.

Randy L. Hays Date Acting Director, SAO Central SAO Central Head of Contracting Activity

11/21/2017 http://vaww.pclo.infoshare.va.gov/PMWeb/VHAPM_Part_806.3.aspx

VHADAYLAWSJ1

Initial Here

JEL

VHACLEMoorT1

Sticky Note

Concur...TPM

2017-11-21T16:33:37-0500

Gina P. Crank 209604

2017-11-22T08:10:54-0500

KRISTINE A. DIXON 295934

2017-12-05T11:04:45-0500

TERRY L. SPITZMILLER 394683

2017-12-18T13:16:53-0800

Randy L. Hays 534204