Anti-Cardiolipin Test Kits (IgG and IgM tests)

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Supbart 12.6, supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.



(ii) The solicitation number is VA259-14-Q-0752 and the solicitation is being issued as a Request for Quotation (RFQ).



(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-76, effective July 25, 2014.



(iv) This acquisition is a Total Small Business set-aside for NAICS code 325413 In-Vitro Diagnostic Substance Manufacturing. Small Business Size Standard is 500 employees.



(v) Contract Line Items - All Annual Volumes of Tests are Estimates



(Both IgG and IgM must have the ability to be tested on a single plate)



Estimated Annual Volume of Tests for IgG Estimated Annual Volume of Tests for IgM Number of Kits for Annual Volume of Tests Shelf Life for Each Kit Cost per Test of each Kit Estimated Annual Cost

Base Year

Oct 1, 2014-Sept 30 2015 3240 3240

Option Year One

Oct 1, 2015-Sept 30, 2016 3240 3240

Option Year Two

Oct 1, 2016-Sept 30, 2017 3240 3240

Option Year Three

Oct 1, 2017-Sept 30, 2018 3240 3240

Option Year Four

Oct 1, 2018-Sept 30, 2019 3240 3240

TOTAL COSTS

__________



Each offeror may have a different number of tests available per kit. Therefore when submitting a quote, offerors shall provide the following information:

a. Number of Kits Needed to complete the Annual Volume of Tests

b. Number of Tests in each Kit

c. The Shelf Life for each Kit

d. Cost per Test of each Kit



(vi) Department of Veterans Affairs, Veterans Health Administration, Eastern Colorado Health Care System in Denver, CO (1055 Clermont Street, Denver, CO 80220) has a requirement for a base plus four option year contract for Anti-Cardiolipin IgG and IgM ELISA Assay. This will be a firm fixed price, cost per test (CPT) Blanket Purchase Agreement. Contractor shall provide Anti-Cardiolipin IgG and IgM ELISA Assay test kits to be used for patient testing at the Eastern Colorado Health Care System in Denver, CO Pathology and Laboratory Medicine Department. Each test kit needs to be an enzyme linked immunoassay (ELISA) for the detection and semiquantitation of IgG and IgM anticardiolipin antibodies, as an aid in assessing the risk of thrombosis in individuals with Systemic Lupus Erythematosus (SLE) or lupus like disorders.



GENERAL NECESSARY CONDITIONS

A. Technical Requirements

a. Each ELISA kit will contain the following:

" Quality Controls

" Calibrators

" Wash Solution

" Diluent

" Conjugate

" Stop Reagents

" ELISA 96 Wells Plate

b. Each kit shall accommodate IgG and IgM Isotypes on a single plate to minimize testing time

c. Kits must be fully complete with all reagent and supplies: Reagent complete kits shall include quality controls, diluent, wash, calibrators, conjugate, substrate and stop reagents

d. Clinical Correlation shall have a choice of single or multi-point calibration

e. Total incubation time shall be no more than 40 minutes at room temperature from start to completion



B. Packaging

All reagents and ELISA wells will be packaged with adequate materials to ensure safe handling. If a kit is delivered and upon inspection is found that the plates, wells or any other materials are broken and cannot be used, the contractor shall deliver a new kit immediately at no additional costs.



C. Technical Support

a. Contractor shall provide call center support and live personnel support in case there are problems while testing, from Monday through Friday 7am - 4pm.

b. If a maintenance or support staff is needed to be in person at the Denver VA Medical Center, contractor shall provide live support at the Denver VA Medical Center.

D. Delivery

Test kits shall be delivered as per need to accommodate shelf life for the base year and subsequent option years.



(vii) Period of Performance



The contract shall be effective for base year with four renewable option years. Period of performance shall be the following:

a. Base Year: October 1, 2014 - September 30, 2015

b. Option Year One: October 1, 2015 - September 30, 2016

c. Option Year Two: October 1, 2016 - September 30, 2017

d. Option Year Three: October 1, 2017 - September 30, 2018

e. Option Year Four: October 1, 2018 - September 30, 2019



Place of Delivery:

Department of Veterans Affairs

Eastern Colorado Health Care System

1055 Clermont Street

Attn: Pathology and Laboratory Medicine

Denver, CO 80220



(viii) The provision at 52.212-1, Instructions to Offerors - Commercial, applies to this acquisition, along with the following Addenda: Addendum to FAR 52.212-1, 52.211-6 Brand Name or Equal, 52.217-5 Evaluation of Options, and 852.273-74 Award Without Exchanges.



(ix) Provision 52.212-2, Evaluation-Commercial Items applies to this acquisition and the following are the evaluation criteria for award:



Evaluation for award shall be Lowest-Priced Technically Acceptable.



The Government reserves the right to award the contract based on initial offers received, without discussions or negotiations of such offers. Therefore, it is important that each offer fully address the requirements stated in this combined synopsis/solicitation.



Technical Requirements:

1. Each ELISA kit will contain the following: Quality Controls, Calibrators, Wash Solution, Diluent, Conjugate, Stop Reagents, ELISA 96 Wells Plate

2. Each kit shall accommodate IgG and IgM Isotypes on a single plate to minimize testing time

3. Kits must be fully complete with all reagent and supplies needed for testing: Reagent complete kits shall include quality controls, diluent, wash, calibrators, conjugate, substrate and stop reagents

4. Clinical Correlation shall have a choice of single or multi-point calibration

5. Total incubation time shall be no more than 40 minutes at room temperature from start to completion



Support and Maintenance Requirement:



1. Contractor shall provide call center support and live personnel support from Monday through Friday 7am - 4pm.

2. Contractor shall provide live support at the Denver VA Medical Center when needed.



(x) Offerors shall include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications - Commercial Items, with your quote.



(xi) FAR 52.212-4, Contract Terms and Conditions-Commercial Items, applies to this acquisition along with the following addenda: Addendum to FAR 52.212-4, 52.217-8 Option to Extend Services, 52.217-9 Option to Extend the Term of the Contract, 52.232-18 - Availability of Funds, 852.203-70 Commercial Advertising, 852.211-73 Brand Name or Equal, 852.232-72 Electronic Submission of Payment Requests, and 852.237-70 Contractor Responsibilities.



(xii) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items, applies to this acquisition along with the following FAR clauses cited in the clause: 52.204-10 Reporting Executive Compensation & First-Tier Subcontract Awards, 52.219-4 Notice of Price Evaluation Preference for HUBZone Small Business Concerns, 52.219-6 Notice of Total Small Business Set-Aside, 52.219-28 Post Award Small Business Program Representation, 52.222-3 Convict Labor, 52.222-19 Child Labor, 52.222-21 Prohibition of Segregated Facilities, 52.222-36 Equal Opportunity for Workers with Disabilities, 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving, 52.225-1 Buy American - Supplies, 52.225-13 Restriction on Certain Foreign Purchases, and 52.232-33 Payment by Electronic Funds Transfer - System for Award Management.



(xiii) The contract will be awarded as a Firm Fixed Price, single-award, Blanket Purchase Agreement with base plus four option years. No other contract requirements or terms and conditions apply.



(xiv) The Defense Priorities and Allocations System (DPAS) does not apply to this acquisition.



(xv) Quotes are Due by Wednesday, September 24th, 12:00pm MST. Quotes shall be sent via email to Contract Specialist, NCO-19, Juanita Street, at Juanita.Street@va.gov.



(xvi) Questions/Answers: All clarification questions by offerors are due by Friday, September 19th, 12:00pm MST. For questions regarding the solicitation, please contact Contract Specialist, NCO-19, Juanita Street, at Juanita.Street@va.gov. All questions must be in writing.