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Identification

Reference Number: 22017983
Request ID:
Date First Offered10/06/2009
Title:DPH Rapid HIV Kits for Oral Fluid

Agency Reference Number:PSD500
Agency:DPH - Public Health
Purchasing Agency:DPH - Public Health
Purchasing Agency SPO:Gary Robinson

Status: Closed

Overview

Description and Specifications:
The Purchasing Agency has identified a programmatic need that they believe can be met by only one vendor—OraSure Technologies, Inc.

This Notice shows the determination with justification that this vendor is the

_X__ Sole Source (there are no other sources that can meet the need)
___ Sole Economically Feasible Source (there may be other sources, but using them is not economically feasible).

Details of that determination and other information are shown in this Notice.

We are seeking information from the public to help us decide if the determination is accurate. To that end we will accept written comments and will hold a public hearing on the matter (details below) at which time interested parties may comment for or against the determination. Testimony or written comments must clearly and concisely state the case and should refer to and address one or more points presented in this Notice.

Public Hearing—Registration Requirement
A public hearing will be held at which time interested parties may testify for or against the sole/sole economically feasible source determination described in this Notice. If you wish to testify, you must register in advance. Walk-in testimony may be allowed depending on volume of business.

Hearing details:
Date and time: October 21, 2009 at 1:00 p.m. Central Time
Location: William G. Stratton Building
8th floor, Room 801
Springfield, Illinois 62706

Registration:
Deadline to register: October 16, 2009; Noon Central Time
Register with the Notice Contact identified later in this Notice.


Written Comments—Submission.
Written comments may be submitted in lieu of or in addition to oral testimony. Written comments must be received no later than the Notice Expiration Date mentioned in this Notice. If submitted by mail, you must allow sufficient time for comments to reach the destination by the deadline. Submit written comments to the Notice Contact identified later in this Notice. Please submit written comments by e-mail if possible.


The Hearing Procedure will be as follows:

Hearing Procedure
The CPO shall designate one to three State employees to act as the Hearing Committee to hear and consider evidence and make a recommendation to the CPO regarding the validity of the sole source determination. The CPO shall designate a Presiding Officer from among the Hearing Committee members, who shall be responsible for the orderly conduct of the meeting by exercising discretion in
a. starting and ending the hearing
b. setting the order of activities
c. setting reasonable time limits for oral statements
d. resolving any conflicts that may arise during the hearing.

The hearing is for the purpose of receiving information from the public in a reasonable manner. Formal rules of evidence will not apply, nor will the hearing be conducted in the manner of a trial. The Committee shall produce minutes of the hearing and may record it to aid in producing minutes.

The Presiding Officer shall have the Procuring Agency’s sole/sole economically feasible source determination as posted to the Procurement Bulletin placed into the record and a copy shall be posted in the meeting room.

A representative of the Procuring Agency shall attend the hearing and confirm the determination.

Public Comments and Testimony. Interested parties wishing to comment for or against the determination may do so in writing or in person.

Written Comments. All written comments received by the Notice Closing Date will be considered. All such comments shall be considered public record and open to review in accordance with the Illinois Freedom of Information Act.

Testimony. Any party who wishes to testify must register in advance to guarantee an opportunity to testify. Registration begins on the date the Notice is posted to the Bulletin. Registration information will be stated in the Notice. Individuals who have not registered in advance may be heard, time permitting, at the discretion of the Presiding Officer. An individual will be heard only once on a particular item.

No Written Comments, No Testimony. If the Committee has not received any written comments and no one has registered to testify for a particular item, those facts shall be noted and the hearing shall be concluded for that item.

Written Comments; No Testimony. If the Committee has received written comments, but no one has registered to testify, the name and affiliation of any person submitting written comments shall be stated, and the hearing shall be concluded for that item.

Testimony; with or without Written Comments. If the Committee has received a request to testify or has received written comments, the name and affiliation of any such person shall be stated. Individuals who have registered to testify will be called and given the opportunity to state their case. Individuals who did not register in advance will be allowed to testify time permitting at the determination of the Presiding Officer.

Each party testifying must complete a witness slip and provide it to the Presiding Office as instructed.

Each interested party shall have at least three minutes to present their position with more time allowed at the discretion of the Presiding Officer based on the complexity of the issue and the press of other business at the hearing.

Members of the Committee may ask questions or request further written information.

Members of the Committee will not respond to substantive questions at the hearing nor make commitments regarding the content of their recommendation.

The Presiding Officer may terminate an individual’s right to address the Committee if the individual becomes abusive or persists in presenting irrelevant information.

Committee Review of Evidence and Recommendation. After conclusion of the hearing the Committee shall review the Procuring Agency’s determination, any information obtained from public comment (written or oral), the applicable sections of the Procurement Code and Rules, and any other information deemed relevant. The Committee shall make a written finding and recommendation to the Chief Procurement Officer by simple majority decision based on a preponderance of evidence.

CPO Makes Final Decision. The Chief Procurement Officer shall make the final decision in writing after considering the Committee’s finding and recommendation.

The final decision of the CPO to uphold or disallow the sole/sole economically feasible source decision shall be placed in the procurement file and published in the Procurement Bulletin.

If the CPO upholds the sole/sole economically feasible source decision, the contract may be signed on the effective date of the CPO’s decision.

If we decide to cancel the award, we will publish notice of that action in a subsequent issue of the Bulletin.

Description and Specifications

This procurement is to continue rapid HIV antibody testing statewide and to establish an annual contract for the State of Illinois to purchase an HIV-1 and HIV-2 detection kit that is relatively non-invasive, can be easily used with minimal training, and can be taken to “at risk” populations. The kits must be FDA licensed for the detection of antibodies to HIV-1 and HIV-2 in human specimens. . An FDA approved kit is necessary to ensure that the results are of high quality, and to reduce the liability of the State in providing screening test results.

In an effort to detect, educate, counsel and treat individuals with HIV infection, AIDS and AIDS-related conditions, the Illinois Department of Public Health conducts screening tests to detect antibodies to HIV-1/HIV-2.

This contract will provide a supply of HIV-1 and HIV-2 test kits that will be used at more than 50 clinic sites across Illinois. The detection of HIV-1 and HIV-2 antibodies will provide the opportunity to intervene with individuals, providing education on how to prevent the spread of the disease. The kits are capable of detecting both forms of the Human Immunodeficiency Virus. The result will be a more effective reduction in the spread of HIV in Illinois.

If not used, the health of Illinois citizens will be compromised if quality HIV-1 and HIV-2 detection is not provided to high risk individuals presenting at STD clinics, drug treatment clinics, anonymous counseling and testing clinics, outreach applications, etc.

Quantity

Approximately 100 Kits of HIV-1/2 Controls and Negative control; approximately 700 cases of OraQuick Advance Rapid HIV ½ with 100 kits (test device, package instruction insert, patient letter); and, approximately 2 cases of OraQuick Advance Rapid HIV ½ with 25 kits (test device, package instruction insert, patient letter).


When is supply or service needed?

November 1, 2009 through October 31, 2010

Key Information

Notice Type:Sole Source
Notice Stage:
<Select Notice Stage>

Published:10/06/2009
Notice Expiration Date:11/05/2009
Sole Source Only Justification:The Purchasing Agency has considered and provided a response to each of the following Justification Inquiries to show why the selected vendor is sole or sole economically feasible source.

1. If Sole Source: Provide a general explanation why this is the only vendor that can provide the supply or service to meet the agency’s needs.

Other companies provide rapid tests for HIV antibodies that are FDA approved. However, this is the only company that provides an FDA approved rapid test for both HIV-1 and HIV-2 strains of Human Immunodeficiency Virus, the virus that causes AIDS; and that does not require a “blood draw”; that is, it uses non-invasive oral fluid from the patient or uses a single drop of blood rather than a syringe full of blood. This product is currently the only product available that can be used to test oral specimens for HIV. Oral specimen collection does not have the same infection control requirements as blood collection. This is an advantage for our community based organizations that serve the majority of at-risk clients through outreach. Specimen collection using this device does require any special degree.

2. Describe what is unique about the needed supply or service to justify a sole source purchase?

This vendor, OraSure Technologies, Inc. holds the patent on this product which is designed specifically for high risk populations in a non-medical setting (that is, outside of a doctor’s office or hospital laboratory). OraSure Technologies, Inc. is the only licensed manufacturer of the OraQuick ADVANCE Rapid HIV-1/2 Antibody Test, product numbers 1001-0079 (25 count) and P/N 1001-0078 (100 count). OraSure Technologies, Inc. is also the sole source for obtaining this OraQuick ADVANCE Rapid HIV-1/2 Antibody Test for Departments of Health.

3. Are there statutory or regulatory requirements that preclude or limit the ability to use a competitive method of source selection?

There are no statutory or regulatory requirements that prevent or limit the ability to use a competitive method of source selection, but as Orasure Technologies, Inc. holds the patents/copyrights for the connecting mechanism, and is the only entity that can supply the product required, there is no competitive opportunity.

4. Describe the market research conducted to support the sole source determination. List the name and contact person of each company contacted and their response.

The Illinois Department of Public Health Division of Laboratories staff has been performing HIV testing with a variety of vendors in a variety of formats over the past 10 years. Vendor representatives for HIV test products contact laboratory staff routinely with new products. The vendors answer questions about the products (FDA approved or for research; blood draw or oral fluid or a small drop of blood; able to detect all variations of HIV; etc.). No other product meets the requirements of the program for outreach to Illinois citizen at risk for HIV in a complete, well tested, non-invasive manner.

5. What competing supplies or services were considered and why were they not an acceptable alternative.

An internet review of FDA approved HIV – 1 and HIV -2 rapid test kits shows that there are no other kits approved for oral fluid testing for HIV-1/2.

6. Could the agency’s need be reasonably modified to allow for competition.

The use of the oral fluid test kits is because of the outreach setting for those at risk populations that do not wish to provide a blood sample for testing. The non-invasive nature of the oral fluid test kits attracts more testing of people than a blood draw.

7. Explain why the price proposed is reasonable and how this was determined (e.g., past price history, current price catalogs, other entity contracts).

The price is reasonable. It compares favorably with other test kits that can only test for one variant of HIV, or only use one method of testing (oral fluid or blood). Due to the quantity of the purchase, Illinois’ price is comparable to the GSA price per unit.

8. Explain what was done to obtain the lowest price from this vendor.

The pricing is comparable to similar tests that test blood specimens from other companies. Over the years of using this product, the price increases have been small and in line with general price increases in medical devices.

9. Was this supply or service purchased in the past and if so what was the method of source selection? If competitively procured, why can’t that method be used today?

This product was used in a pilot study in outreach clinics to test high risk populations (drug users, STD clinic patients, etc.). It was used because it tested for both HIV-1 and HIV-2, was FDA approved, and was non-invasive (no needle stick). This vendor was initially recommended by the Centers for Disease Control and Prevention due to its convenience in outreach settings. OraQuick has been and remains a sole source for this technique of testing (oral fluid antibodies for HIV).

10. If this request is approved, will the State be effectively bound to use this vendor for follow-on procurements (and if so describe)?

No. Renewal is contingent upon mutual agreement between the State and the vendor, and if competing companies develops a similar product, a solicitation for bids will be used to procure the needed products.


11. Describe the impact on the agency if the request is denied and the procurement must be competitively procured.

If the request is denied, the HIV/AIDS program will lose valuable time in procuring a product that will reach high risk individuals in its efforts to intervene and halt the spread of AIDS. Failure to approve this request may also result in service gaps.
If the item were to be competitively procured, the results would be the same as only OraSure Technologies, Inc. is able to supply the patented components.
Accordance with Admin Rule:Item is patented or copyrighted and only available from holder of patent/copyright

Professional & Artistic:No
Small Business Set-Aside:No

Does this solicitation contain a BEP or DBE requirement?:No

Does this solicitation contain a Veteran requirement?:

Relevant Category:Commodities

Total Amount of Award:$2,602,457.40 (Total Dollar Value Only/Includes Any Renewal Options)
Estimated/Actual Value Description:Actual Value as follows:
$867,485.80 (initial 12 month)
$867,485.80 (Renewal 1)
$867,485.80 (Renewal 2)
Length of Initial Term:12
Contract Begin Date:11/01/2009
Contract End Date:10/31/2010
Renewal Terms:2 1-year

Bidder(s)


Number of Responding Bidders:1
Number of Unsuccessful Bidders:0
Total Number Awarded:0

Listing of All Bidders/Offerors Considered But Not Selected:
N/A
Source Selection:N/A

Vendor(s) Selected for Award
Vendor NameAmount of Award BEP Goal % DBE Goal %
OraSure Technologies, Inc.$2,602,457.40

Notice Contact
Name: Ben Bagby
Street Address:401 S. Spring Street
City:Springfield
State:IL
Zip Code:62706
Phone: 217-557-3761
Fax Number:217-558-2697
EMail Address:ben.bagby@illinois.gov

Class Code

Class Codes:3069 Laboratory Supplies

NIGP Code

NIGP Commodity/Service Code:


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