V797P-7323A-006.pdf

VHAPM Part 808.405-6 Limiting Sources Page 1 of 5 Original Date: 08/30/2017

LIMITED SOURCES JUSTIFICATION

ORDER >$150,000

FAR PART 8.405-6

Acquisition Plan Action ID: VA244-18-AP-3914

1. Contracting Activity: : Department of Veterans Affairs, VISN 04, Corporal Michael J. Crescenz VA Medical Center (CMC VAMC), Philadelphia, PA, SAO East, Network Contracting Office 4 (NCO4), Clinical Support Services (Med 2). 2237 # 642-18-2-025-1017.

2. Description of Action: This acquisition is conducted under the authority of the Multiple-Award Schedule Program (41 U.S.C. 251 and 40 U.S.C. 501). Pathology and Laboratory Medicine Service is requesting award of a delivery order on a limited source basis to Abbott Laboratories, Inc under their Federal Supply Class (FSC) 6630 Federal Supply Schedule (FSS) V797P-7323a.

Order against: FSS Contract Number: V797P-7323a.

Name of Proposed Contractor: Abbott Laboratories, Inc., Molecular Division (Abbott)

Street Address: 1300 East Touhy Avenue

City, State, Zip: Des Plaines, IL 60018

Point of Contact: Brittany Bell, 267.438.8053

3. Description of Supplies or Services: The estimated value of the proposed action is $284,856.16 Contemplated delivery order will be for the provision of laboratory reagent supplies to perform Hepatitis C Virus (HCV) genotyping as well as venereal disease testing for Chlamydia and Gonorrhea. In addition to reagent supplies, Abbott will provide and maintain the necessary equipment to perform the testing. See attached spreadsheet (pages 4 and 5) for cost estimate and a complete listing of the reagent testing supplies and equipment services required. Equipment provided and maintained includes, the Abbott m2000, Abbott m2000rt, two computer workstations, and a printer. Note that this equipment is currently on-site. Quantity to be ordered should meet testing needs for a period of 12 months (04/04/2018 04/03/2019).

(4) IDENTIFY THE AUTHORITY AND SUPPORTING RATIONALE (see 8.405-6(a)(1)(i)(A), (B), and (C) or 8.405-6(b)), AND IF APPLICABLE, A DEMONSTRATION OF THE PROPOSED

CONTRACTOR

SERVICE. (CHECK ALL THAT APPLY AND COMPLETE)

An urgent and compelling need exists, and following the ordering procedures would result in unacceptable delays.

Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized: For the last five years, CMC VAMC has standardized their HCV genotyping as well as venereal disease testing for Chlamydia and

VHAPM Part 808.405-6 Limiting Sources Page 2 of 5

Gonorrhea around the Abbott reagent supplies and equipment. Abbott reagent supplies are only compatible with the Abbott testing equipment such as the Abbott m2000 and Abbott m2000rt.

Availability of reagent supplies must be limited to Abbott as only procurement of the needed reagents from Abbott will allow for continuation of testing and regular provision of treatment to patients.

Procurement from Abbott will also allow the Pathology and Laboratory Medicine Service to avoid delays caused by having to remove existing equipment, install new equipment from a competitor, and learn a new testing protocol/procedure for HCV genotyping and Chlamydia and Gonorrhea.

Also note that patient testing is generally performed daily. A lack of these reagents could result in delayed patient testing. Delays in testing are likely to result in delays in treatment of HCV and Chlamydia and Gonorrhea. Such delays must be prevented.

In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition. The proprietary data is:

(If FAR 8.405-6(a)(2)iii before posting. Do not include specific proprietary data. Only mention the type of equipment, procedure, etc. to show that proprietary supplies or services are being procured.)

These are for existing equipment.

The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. Describe the equipment/function you have now and how the new item/service must coordinate, connect, or interface with the existing system.

Abbott reagent supplies are only compatible with the Abbott testing equipment such as the Abbott m2000 and Abbott m2000rt. Abbott is the only provider and manufacturer of compatible reagents for its equipment.

(5) DESCRIBE WHY YOU BELIEVE THE ORDER REPRESENTS THE BEST VALUE

CONSISTENT WITH FAR 8.404(d) TO AID THE CONTRACTING OFFICER IN MAKING THIS BEST VALUE DETERMINATION: Award of the described delivery order to Abbott represents the best value to Government for the following reasons: (1) The price offered by Abbott for testing supplies and equipment has been determined fair and reasonable by a VA contracting officer at

-7323a. (2) The supplies and equipment offered by Abbott are the most expedient means to ensure testing and patient care continue uninterrupted. (3) The supplies and equipment offered by Abbott are in wide use throughout the healthcare market place and are generally accepted to be accurate and reliable.

(6) DESCRIBE THE MARKET RESEARCH CONDUCTED AMONG SCHEDULE HOLDERS

AND THE RESULTS OR A STATEMENT OF THE REASON MARKET RESEARCH WAS NOT

CONDUCTED: Market research was conducted among various FSS schedule holders. Results of market research indicate that provision of laboratory reagent supplies to perform Hepatitis C Virus (HCV) genotyping as well as venereal disease testing for Chlamydia and Gonorrhea can only be provided by Abbott, as only Abbott reagent supplies are compatible with the testing equipment such as the Abbott m2000 and Abbott m2000rt. Abbott is the only provider/manufacturer of compatible reagents for its equipment.

VHAPM Part 808.405-6 Limiting Sources Page 3 of 5

(7) ANY OTHER FACTS SUPPORTING THE JUSTIFICATION: N/A

(8) A STATEMENT OF THE ACTIONS, IF ANY, THE AGENCY MAY TAKE TO REMOVE

OR OVERCOME ANY BARRIERS THAT LED TO THE RESTRICTED CONSIDERATION

BEFORE ANY SUBSEQUENT ACQUISITION FOR THE SUPPLIES OR SERVICES IS MADE:

(9) 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. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. (This responsibility and accountability.)

SIGNATURE DATE

Jacqueline Pento Supervisor, Microbiology_ Pathology & Laboratory Medicine

NAME TITLE SERVICE LINE/SECTION

CMC VAMC

FACILITY

(10) APPROVALS IN ACCORDANCE WITH THE VHAPM Part 806.3 OFOC SOP:

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

CONTRACTING OFFICER SIGNATURE DATE

Matthew D. Parlett, Contracting Officer NCO4, Clinical Support Services (Med 2)

NAME AND TITLE FACILITY

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.

SIGNATURE DATE

Nancy L. Porter Branch Chief, NCO4, Clinical Support Services (Med 2)

4/3/18

04/03/2018

VHAPM Part 808.405-6 Limiting Sources Page 4 of 5

Item Number Description QTY UoM

Unit Price Part #

TOTAL

PRICE

Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) Amplification reagent Kit 24 KT

2,362.00

08L07-

56,688.00

CT/NG

CONTROL KIT 11 KT

475.00

08L07-

5,225.00

MULTI-

COLLECT

pierceable cap

KIT 6 KT

750.00

09K12-

4,500.00

HCV GT sample prep 13 KT

408.00

04J70-

5,304.00

HCV GT control kit 20 KT

475.01

08L21-

9,500.20

HCV GENOTYPE

II

AMPLIFICATION

KIT 69 KT

1,920.00

08L21-

132,480.00

CTNG sample prep 22 KT

575.00

06K12-

12,650.00

0008 1 ml pipet tips 25 KT 242.00

04J71-

6,050.00

0009 200 ul pipet tips 4 BX 244.00

04J71-

976.00

0010 Reaction vessels 1 BX 105.00

04J71-

105.00

200 ml reagent vessel 6 BX

29.00

04J71-

174.00

0012 96 well plates 9 BX 196.00

04J71-

1,764.00

96 well optical reaction 5 BX

49.00

04J71-

245.00

0014 master mix tubes 5 BX 45.00

04J71-

225.00

VHAPM Part 808.405-6 Limiting Sources Page 5 of 5

Equipment Rental & Service:

m2000sp - Sample Extraction Automation - 09K14-090 - $2,058.10 per month.

m2000rt - Realtime PCR - 09K15-090 - $748.40 per month.

Performance Plus Service Agreement

- m200sp - $934.33 per month.

Performance Plus Service Agreement m2000rt - $340.00 per month.

Total monthly price = $4,080.83. 12 MO

4,080.83

48,969.96

TOTAL

284,856.16