Reference Laboratory Testing

Added: Apr 16, 2015 3:26 pm This is a Combined Synopsis/Solicitation for commercial items prepared in accordance with the format in FAR 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only Solicitation; quotes are being requested and a written Solicitation will not be issued.

Solicitation number VA249-15-Q-0415 is issued as a Request for Quotation (RFQ). This requirement is a Total Small Business Set Aside.
NAICS: The NAICS is 621511 and the small business size standard is $32,500,000.00. Any firm that is not considered a small business under this NAICS code should not submit a response to this notice.

To be receiving a government award, the offeror must be currently registered in System for Award Management (SAM) at www.sam.gov. Offerors are encouraged to go to the SAM database www.sam.gov and start the registration process as soon as possible to avoid possible delays should the contractor be selected as a prospective awardee.
Online Representation and Certification Application (ORCA) must also be current to qualify to receive a contract award. . Offeror may register with CCR at www.orca.bpn.gov.

Period of Performance (POP): The estimated base POP is from 19 May 2015 through 18 May 2016 plus 4 one-year options if all options are exercised, ending 2020. Options may be exercised unilaterally by the Government.

Description of Services: See the attached Statement of Work.

Location of Performance: See the attached Statement of Work.

Contract Type: The government anticipates awarding a Firm Fixed Price award.

Award will be made to lowest price quote which conforms to the requirements within this solicitation.

The minimum to satisfy this entire base plus 4-option year contract will be $1.00

To receive consideration as SDVOSB or VOSB, the firm must be registered and verified in the VIP database at www.vip.vetbiz.gov.

Submitting Quote: Contractor shall submit their quote on company letterhead and shall include unit price, total , unit qty and item description as specified above, as offered discounts, proposed delivery time, name, address, and telephone number of the offeror, firm's DUNS# and ORCA document in SAM at www.sam.gov, terms of any express warranty, unit price, overall total

price, applicable shipping charges, completed copy of 52.212-3 Offerors Representations and Certifications- Commercial Items, and ORCA document.

Quotes must be received by 7 May 2015. Email your quote to Kathleen Hoffman at Kathleen.Hoffman@va.gov, faxed to 615-849-3769 or mail to the following address: Department of Veteran Affairs, Network Contract Activity, NCO 9, ATTN: Kathleen Hoffman, 1639 Medical Center Parkway, STE 400, Nashville TN, 37129. All questions should be emailed to Kathleen.Hoffman@va.gov.

Solicitation document and incorporated provisions and clauses apply to this acquisition: 52.204- 7- Central Contractor Registration; 52.212-1-Instructions to Offerors-Commercial Items; 52.212-3, Offeror Representations and Certifications-Commercial Items 52.212-4 Contract Terms and Conditions Commercial Items; 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items including subparagraphs: 52.232-34, Payment by Electronic Funds Transfer-Other Than Central Contractor Registration; 52.333-3 Protest After Award;

52.212-2 Evaluation -Commercial Items; 52.217-8 Option for increased Quantity-separate priced line item 52.217-9 Option to extend the term of the contract. VAAR 852.215-70, Service- Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors, and VAAR 852.215-71, Evaluation Factor Commitments; FAR 52.219-9, Small Business Subcontracting Plan, and VAAR 852.219-9, VA Small Business Subcontracting Plan Minimum Requirements; and 52.219-14 Limitation on Subcontracting.

Full text can be obtained at www.arnnet.gov.

DISCLAIMER AND IMPORTANT NOTES: The government is in no way obligated to do business with or enter into the award a contract to any firm or its affiliates or otherwise pay for the information provided in this synopsis.

Statement of Work to be performed follows.

Statement of Work
Special Fungal Disease Testing Services

Requirements:

The VA Tennessee Valley Healthcare System (TVHS) Path&Lab (P&LMS) is in need of reference lab services for detection of Coccidioides Antigen and Histoplasma Antigen by a Quantitative Enzyme Immunoassay, and the Platelia Aspergiullus Antigen by Enzyme Immunoassay. These are proprietary quantitative tests developed and performed at MiraVista Diagnostics. These are proprietary tests and patented tests and cannot be substituted by any other test. These tests will aid in the rapid and noninvasive diagnosis and management of Veterans with serious manifestations of coccidioides, histoplamosis or aspergiullus by detecting the corresponding antigen. Measurement of the antigen in both urine and serum offers the highest sensitivity for diagnosis of these diseases/infections.

The vendor must be able to provide turnaround of test results within 36 hours, from receipt of specimen to delivery of results to TVHS, Nashville Campus in order to enable diagnosis of fungal infections and expedite treatment. Results to be sent via secure method using the following information:

Primary (required) reporting method:
" Fax (secure line): (615) 873-8381 *REQUIRED MODE FOR REPORTING*

Secondary reporting methods:
" Attn: Specimen Processing P&LMS (113)
" Address: 1310 24th Ave. South, Nashville, TN 37209;

These results must be delivered with a confirmed receipt, electronically with the option for an additional faxed copy. Therefore, vendors must prove that they have successfully ordered the patented MiraVista Diagnostics tests with the specified turnaround times of results over the last three years.

Firms offering a response to this notice should ensure that their registration in the System for Award Management (SAM) database https://www.sam.gov/portal/public/SAM/ is current and should ensure that the applicable NAICS code (621511) is included in the SAM profile prior to submission of quotations. Firms must also be categorized as a small business in accordance of the Small Business Association.

The anticipated Base period of this contract shall be one year from date of award. There shall be 4 possible option years to exercise, depending on the needs of the VA. The solicitation will result in the award of a single contract.

1. Background: The VA Tennessee Valley Healthcare System Path&Lab (P&LMS) is in need of reference lab services for detection specific fungal disease to include Histoplasmosis, Blastomycosis, Coccidioidomycosis, Aspergillosis, Fungitell, and Itraconazole Drug Levels. A number of specific tests needed are proprietary quantitative test developed and performed at MiraVista Diagnostics, and cannot be substituted by any other test.

The vendor must be able to arrange short turnaround times within 36 hours from receipt of specimen to delivery of results to TVHS, in order to enable diagnosis of fungal infections and expedite treatment.


2. Scope.

Indefinite delivery, indefinite quantity (IDIQ) of patient serum, urine, bronchial lavage of cerebral spinal fluid (CSF) for fungal testing to include MiraVista patented testing for Histoplasmosis, Coccidioidomycosis, and Aspergillosis, as well as testing for Blastomycosis, Fungitell, and Itraconazole Drug Levels as needed within the year from the date of award.
The period of performance with be one year from date of award with 4 one-year option periods thereafter.



Period Dates
Base Based upon date of award
Option Year 1 1 year based upon base year
Option Year 2 1 year based upon opt year 1
Option Year 3 1 year based upon opt year 2
Option Year 4 1 year based upon opt year 3
Total Five years of service



3. Specific Tasks.

The Reference Laboratory shall provide in accordance with all applicable federal, state, and local regulations, laws, and ordinances, and in accordance with the specifications outlined for accreditation certification, patient testing to detect fungal diseases. The chosen laboratory must be accredited by the Centers for Medicare and Medicare Services Clinical Laboratory Improvement Amendments (CLIA) and the College of American Pathologists (CAP).

Estimated quantities of tests will depend upon need of the facility based upon changes in situations, patient specifics, and physician requests.

See tables listing specific tests.

Additionally vendor will be able to test all body fluids for requested antibody / antigens. This includes, but is not limited to, CSF, bronchial lavage, urine and serum.
The following are Tables of the requested testing with referenced CPT codes. Not all tests will be utilized. But all must be priced for potential need. A price increase cannot be implemented without official notification. Proposed price increases may not exceed 3% per test per year and proposed price increases must be stated in the quote. Validation of proposed increases must be provided at the time of the request.

Base Period of Performance based up on date of award and run for one year.





CLIN Test Name & CPT code
(bolded are the required tests that are known to be patented by MiraVista Diagnostics)
Price per test Estimated Annual Volume

0001
Itraconazole concentration, CPT code 80299
$

0002
Histoplasma Quantitative Antigen EIA, CPT code 87385
$
114

0003
Blastomyces Antigen EIA CPT code 87449
$

0004
Coccidioides Antigen EIA CPT code 87449
$
7

0005
Aspergillus Antigen EIA, CPT code 87305
$
100

0006
Fungitell (1?3)-?-D-Glucan Assay, CPT code 87449
$

0007
Aspergillus Antibody IgG EIA, CPT code 86606
$

0008
Coccidiodes Antibody by Immunodiffusion, CPT code 86635
$

0009
Cryptococcal Antigen Latex Agglutination CPT code 86403
$

0010
Histoplasma Antibody by Immunodiffusion CPT code 86698
$

0011
Blastomyces Antibody by Immunodiffusion CPT code 86612
$

0012
Aspergillus Antibody by Immunodiffusion CPT 86606
$

Base Year Total $_

1st Optional Period of Performance established up on base period to run for one year.




CLIN Test Name & CPT code
(bolded are the required tests that are known to be patented by MiraVista Diagnostics)
Price per test Estimated Annual Volume

1001
Itraconazole concentration, CPT code 80299
$

1002
Histoplasma Quantitative Antigen EIA, CPT code 87385
$
114

1003
Blastomyces Antigen EIA CPT code 87449
$

1004
Coccidioides Antigen EIA CPT code 87449
$
7

1005
Aspergillus Antigen EIA, CPT code 87305
$
100

1006
Fungitell (1?3)-?-D-Glucan Assay, CPT code 87449
$

1007
Aspergillus Antibody IgG EIA, CPT code 86606
$

1008
Coccidiodes Antibody by Immunodiffusion, CPT code 86635
$

1009
Cryptococcal Antigen Latex Agglutination CPT code 86403
$

1010
Histoplasma Antibody by Immunodiffusion CPT code 86698
$

1011
Blastomyces Antibody by Immunodiffusion CPT code 86612
$

1012
Aspergillus Antibody by Immunodiffusion CPT 86606
$

Option Year 1 Year Total $_

2nd Optional Period of Performance established up on base period to run for one year.




CLIN Test Name & CPT code
(bolded are the required tests that are known to be patented by MiraVista Diagnostics)
Price per test Estimated Annual Volume

2001
Itraconazole concentration, CPT code 80299
$

2002
Histoplasma Quantitative Antigen EIA, CPT code 87385
$
114

2003
Blastomyces Antigen EIA CPT code 87449
$

2004
Coccidioides Antigen EIA CPT code 87449
$
7

2005
Aspergillus Antigen EIA, CPT code 87305
$
100

2006
Fungitell (1?3)-?-D-Glucan Assay, CPT code 87449
$

2007
Aspergillus Antibody IgG EIA, CPT code 86606
$

2008
Coccidiodes Antibody by Immunodiffusion, CPT code 86635
$

2009
Cryptococcal Antigen Latex Agglutination CPT code 86403
$

2010
Histoplasma Antibody by Immunodiffusion CPT code 86698
$

2011
Blastomyces Antibody by Immunodiffusion CPT code 86612
$

2012
Aspergillus Antibody by Immunodiffusion CPT 86606
$

Option Year 2 Year Total $_

3rd Optional Period of Performance established up on base period to run for one year.




CLIN Test Name & CPT code
(bolded are the required tests that are known to be patented by MiraVista Diagnostics)
Price per test Estimated Annual Volume

3001
Itraconazole concentration, CPT code 80299
$

3002
Histoplasma Quantitative Antigen EIA, CPT code 87385
$
114

3003
Blastomyces Antigen EIA CPT code 87449
$

3004
Coccidioides Antigen EIA CPT code 87449
$
7

3005
Aspergillus Antigen EIA, CPT code 87305
$
100

3006
Fungitell (1?3)-?-D-Glucan Assay, CPT code 87449
$

3007
Aspergillus Antibody IgG EIA, CPT code 86606
$

3008
Coccidiodes Antibody by Immunodiffusion, CPT code 86635
$

3009
Cryptococcal Antigen Latex Agglutination CPT code 86403
$

3010
Histoplasma Antibody by Immunodiffusion CPT code 86698
$

3011
Blastomyces Antibody by Immunodiffusion CPT code 86612
$

3012
Aspergillus Antibody by Immunodiffusion CPT 86606
$

Option Year 3 Year Total $_

4th Optional Period of Performance established up on base period to run for one year.




CLIN Test Name & CPT code
(bolded are the required tests that are known to be patented by MiraVista Diagnostics)
Price per test Estimated Annual Volume

4001
Itraconazole concentration, CPT code 80299
$

4002
Histoplasma Quantitative Antigen EIA, CPT code 87385
$
114

4003
Blastomyces Antigen EIA CPT code 87449
$

4004
Coccidioides Antigen EIA CPT code 87449
$
7

4005
Aspergillus Antigen EIA, CPT code 87305
$
100

4006
Fungitell (1?3)-?-D-Glucan Assay, CPT code 87449
$

4007
Aspergillus Antibody IgG EIA, CPT code 86606
$

4008
Coccidiodes Antibody by Immunodiffusion, CPT code 86635
$

4009
Cryptococcal Antigen Latex Agglutination CPT code 86403
$

4010
Histoplasma Antibody by Immunodiffusion CPT code 86698
$

4011
Blastomyces Antibody by Immunodiffusion CPT code 86612
$

4012
Aspergillus Antibody by Immunodiffusion CPT 86606
$

Option Year 4 Year Total $_

4. Performance Monitoring

Performance monitoring will be done by a third party; the organization with which the reference lab has accreditation. The reference lab will maintain on file their current accreditation and make it available for review upon request.


5. Other Pertinent Information or Special Considerations.

a. Identification of Possible Follow-on Work. NA

b. Identification of Potential Conflicts of Interest (COI). All parties involved with the review and establishment of this request do not have any conflicts of interest with potential vendors.

c. Identification of Non-Disclosure Requirements. NA

d. Packaging, Packing and Shipping Instructions. NA

e. Inspection and Acceptance Criteria. See performance monitoring

6. Risk Control

NA