REQUEST FOR QUOTATIONS (THIS IS NOT AN ORDER)

THIS RFQ          IS    X   IS NOT A SMALL BUSINESS SET-ASIDE.

PAGE       OF      PAGES   1        8

1.  REQUEST NO. 2007-Q-09877

2.   DATE ISSUED 07/31/2007

3.  REQUISITION/PURCHASE REQUEST NO. 000HCVCH-2007-46765

4.  CERT. FOR NAT. DEF.      UNDER BDSA REG. 2      AND/OR DMS REG. 1

RATING

OTHER (See Schedule)   FOB DESTINATION     7.  DELIVERY   5a.  ISSUED BY Centers for Disease Control and Prevention (PGO) Acquisition & Assistance Branch B 2920 Brandywine Road Atlanta GA 303415539

6.  DELIVERY BY (Date) One year from date of award

5b.  FOR INFORMATION CALL  (No collect calls)

NAME

TELEPHONE NUMBER

AREA CODE

NUMBER

Berta Biltz

(770)

488-2643 x

8.  TO:

9.  DESTINATION

a. NAME

b. COMPANY

a. NAME OF CONSIGNEE

c. STREET ADDRESS

b. STREET ADDRESS

c. CITY

d. CITY

e. STATE

f. ZIP CODE

d. STATE

e. ZIP CODE

10.  PLEASE FURNISH QUOTATIONS TO      THE ISSUING OFFICE IN BLOCK 5a ON       OR BEFORE CLOSE OF BUSINESS (Date) 08/08/2007

IMPORTANT:  This is a request for information, and quotations furnished are not offers.  If you are unable to quote, please so indicate on this form and return it.  This request does not commit the Government to pay any costs incurred in the preparation of the submission of this quotation or to contract for supplies or services.  Supplies are of domestic origin unless otherwise indicated by quoter.  Any representations and/or certifications attached to this Request for Quotations must be completed by the quoter.

11.  SCHEDULE (Include applicable Federal, State and local taxes)

ITEM NO. (a)

SUPPLIES/SERVICES (b)

QUANTITY (c)

UNIT (d)

UNIT PRICE (e)

AMOUNT (f)

“See Continuation Page”

12.  DISCOUNT FOR PROMPT PAYMENT

a. 10 CALENDAR DAYS             %

b. 20 CALENDAR DAYS             %

c. 30 CALENDAR DAYS             %

d. CALENDAR DAYS

NUMBER

PERCENTAGE

NOTE:  Additional provisions and representations         are           are not attached.

13.  NAME AND ADDRESS OF QUOTER

14.  SIGNATURE OF PERSON AUTHORIZED TO       SIGN QUOTATION

15.  DATE OF        QUOTATION

a. NAME OF QUOTER

b. STREET ADDRESS

16. SIGNER

a. NAME (Type or print)

b. TELEPHONE

c. COUNTY

AREA CODE

d. CITY

e. STATE

f. ZIP CODE

c. TITLE (Type or print)

NUMBER

AUTHORIZED FOR LOCAL REPRODUCTION                                                                                                                                       STANDARD FORM 18 (REV. 6-95)

Previous edition not usable                                                                                                                                                                   Prescribed by GSA

                                                                                                                                                                                                        FAR (48 CFR) 53.215-1(a)

MORGELLONS

As an independent contractor, and not as an agent of the US Government, the contractor shall provide the following deliverables in accordance with Section 4 of  the SOW below : 

STATEMENT OF WORK

1.0  BACKGROUND

Morgellons is an unexplained and debilitating condition that has emerged as a public health concern.  Recently, the Centers for Disease Control and Prevention (CDC) has received an increased number of inquiries from the public, health care providers, public health officials, Congress, and the media regarding this condition.   Persons who suffer from this condition report a range of coetaneous symptoms including crawling, biting and stinging sensations; granules, threads or black speck-like materials on or beneath the skin; and/or skin lesions (e.g., rashes or sores) and some sufferers also report systemic manifestations such as fatigue, mental confusion, short term memory loss, joint pain, and changes in vision.  Moreover, some who suffer from this condition appear to have substantial morbidity and social dysfunction, which can include decreased work productivity or job loss, total disability, familial estrangement, divorce, loss of child custody, home abandonment, and suicidal ideation.     

As of February 2007, approximately 10,000 families had registered with the Morgellon’s Research Foundation (MRF) and felt they or a family member met criteria for Morgellons as defined by the MRF. Of the U.S. families in the MRF registry, 24% reside in California with geographic clustering in the San Francisco metropolitan area. 

The etiology of this condition is unknown, and the medical community has insufficient information to determine whether persons who identify themselves as having this condition have a common cause for their symptoms or share common risk factors.   An epidemiologic investigation is needed to better characterize the clinical and epidemiologic features of this condition; to generate hypotheses about factors that may cause or contribute to sufferers’ symptoms; and to estimate the prevalence of the condition in the population; and to provide information to guide public health recommendations.  A contractor is needed who can provide timely services to assist the CDC in the investigation of this emerging public health problem.

2.0  DESCRIPTION OF WORK

The purpose of this project is to:

2.1.      Describe the clinical and epidemiologic features of persons who have reported themselves as having this unexplained skin condition, including assessing the frequency of co-morbid conditions (e.g., neurocognitive deficits, neurologic conditions, major psychiatric disorders). 

2.2. Collect information to generate hypotheses about possible risk factors for this condition.

2.3. Assess the histopathologic features of the skin condition based on skin biopsies from a sample of affected patients. 

2.4. Characterize fibers or threads obtained from patients with the condition to determine their potential etiology.

2.5. Describe the geographic distribution and estimate rates of illness.

2.6. Describe health care utilization among persons with the condition.

3.0  MINIMUM VENDOR QUALIFICATIONS

In order to successfully perform the required services the vendor shall have the following minimum vendor qualifications:

3.1. Electronic health records that have been implemented in the organization at least since January 2006.

3.2. Ability to conduct electronic queries of medical records, including progress notes, to identify clinical conditions and complaints.

3.3 Health maintenance organization with at least 3 million enrollees and coverage of at least 25% of the population in the chosen geographic area.

3.4. Location in a geographic area with a large number of suspected cases.

3.5. Experience in conducting clinical and epidemiologic studies.

3.6.  Adequate qualified personnel to successfully perform the requested services by the date required.

4.0  DELIVERABLES

The vendor shall provide the following deliverables to the Project Officer by the date required:  

Deliverables                                                                                                    Date Required

4.1. IRB Clearance                                                                                           October 30, 2007

4.2. Database of potential cases (study cohort)                                                            November 30, 2007

4.3. Database containing all results of clinical evaluations,

       Including recorded histories and physicals, laboratory tests

       (See Attachment 001 for required laboratory tests),

       chest x-rays, digital photos, neuorcognitive/neuropsychiatric

        examinations.                                                                                          March 1, 2008

4.4.  All skin biopsy specimens and fiber samples

       collected from case-patients          .                                                                       March 1, 2008

4.5. Electronic database containing demographic information,

       zip code of residence, relevant past health history,

       such as medications, provider visits, and hospitalizations

       for cases.  Database should include a unique

       patient identifier to allow linkage of clinical and

       other test results with demographic, healthcare utilization,

       and survey data.                                                                                        April 30, 2008

4.6.  Database with denominators for all visits (total and by specialty)

        and hospitalizations during study period to allow estimation

        of disease rates in the population.                                                                                   May 30, 2008

5.0  PERIOD OF PERFORMANCE

The period of performance shall be from the date of the award through May 30, 2008 . Upon satisfactory completion of the services and delivery of the goods, the vendor shall submit an invoice to CDC.

6.0  Clauses and Provisions

The Following HHS Clauses applies to this acquisition:

6.1  HHSAR 352.270-8b Protection of Human Subjects (Jan 2001)

          (a) The Contractor agrees that the rights and welfare of human subjects involved in research under this contract shall be protected in accordance with 45 CFR Part 46 and with the Contractor's current Assurance of Compliance on file with the Office for Protection from Research Risks (OPRR), National Institutes of Health (NIH). The Contractor further agrees to provide certification at least annually that the Institutional Review Board has reviewed and approved the procedures, which involve human subjects in accordance with 45 CFR Part 46 and the Assurance of Compliance.

          (b) The Contractor shall bear full responsibility for the performance of all work and services involving the use of human subjects under this contract in a proper manner and as safely as is feasible. The parties hereto agree that the Contractor retains the right to control and direct the performance of all work under this contract. Nothing in this contract shall be deemed to constitute the Contractor or any subcontractor, agent or employee of the Contractor, or any other person, organization, institution, or group of any kind whatsoever, as the agent or employee of the Government. The Contractor agrees that it has entered into this contract and will discharge its obligations, duties, and undertakings and the work pursuant thereto, whether requiring professional judgment or otherwise, as an independent contractor without imputing liability on the part of the Government for the acts of the Contractor or its employees.

          (c) If at any time during the performance of this contract, the Contracting officer determines, in consultation with the OPRR, NIH, that the Contractor is not in compliance with any of the requirements and/or standards stated in paragraphs (a) and (b) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer's written notice of suspension, the Contracting Officer may, in consultation with OPRR, NIH, terminate this contract in a whole or in part, and the Contractor's name may be removed form the list of those contractors with approved Health and Human Services Human Subject Assurances.

(End of clause)

6.2.  Rights in Data

All data, information, reports, and other products of this effort are exclusively the property of the federal government and the contractor shall not publish, share, distribute or otherwise release any of this information except with the explicit written permission of the contracting or project officer.  Moreover, some of the materials may be designated as national security classified, sensitive but unclassified or other limited use category further restricting its distribution.

6.3  FAR Clauses

The following FAR clauses and provisions apply to this acquisition: The full text of the clauses can be accessed electronically at these addresses: http://www.acqnet.gov/  and http://farsite.hill.af.mil/ .