SOURCES SOUGHT
65 -- Diagnostic testing required under Internal Review Board (IRB) - approved clinical protocols
- Notice Date
- 4/5/2013
- Notice Type
- Sources Sought
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- HHS-NIH-NHLBI-CSB-(SBSS)2013-110-DDC
- Archive Date
- 5/4/2013
- Point of Contact
- Deborah - Coulter, Phone: (301) 435-0368
- E-Mail Address
-
dc143b@nih.gov
(dc143b@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources: (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantage businesses and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code (621511, size standard $13.0) should not submit a response to this notice. 2. Notice Information a. Background: Investigators in the Hematology Branch study the clinical features and laboratory pathophysiology of a wide variety of bone marrow failure states, hematological malignancies, and single or multi-lineage cytopenias. There are many active IRB-approved Hematology Branch research protocols for these types of subjects which require diagnostic testing. Many of these patients participate in Protocol # 97-H-0041 or Project #94-H-0010, but numerous other protocols require specialized diagnostic testing. Some of the diagnostic testing for these protocols includes chromosomal analysis/Cytogenetics techniques such as karyotyping and fluorescent in situ hybridization (FISH) which have been used to study chromosomal abnormalities. Routine laboratory assessments may include bone marrow aspiration and biopsy for morphology, and when indicated, additional Cytogenetics, in vitro colony growth, flow cytometry, and RNA or DNA analysis. Sometimes we request different tests for the same sample limiting our choices of vendors. A summarized list of tests is included at the bottom of this document. b. Purpose and Objectives: Many of the active IRB-approved Hematology Branch research protocols require chromosomal analysis/Cytogenetics techniques such as karyotyping and fluorescent in situ hybridization (FISH) which have been used to study chromosomal abnormalities. Routine laboratory assessments may include bone marrow aspiration and biopsy for morphology, and when indicated, additional Cytogenetics, in vitro colony growth, flow cytometry, and RNA or DNA analysis. This data obtained from these test will aid in the subsequent treatment of the patient as detailed in the protocol. c. Project Requirements: 1.) The Branch needs access to a clinical testing service which can perform most any clinical test so that we may send a sample to one lab for single or multiple tests of the same samples if necessary. 2.) The service provider must provide consistent and accurate results. 3.) The results should be sent to the Branch within a timely manner. 4.) A testing service that can guarantee sample pickup until 8:00pm and delivery to the testing lab by 10:00am the following day. 5.) Service provider must have proper certification for clinical testing and follow regulations established for clinical testing. Non-critical elements: 1) Service provider should provide our Branch with the reagents needed to submit samples. This is to assure consistency and quality control. 2) Service provider should provide a means of printing requests and labels for samples. This is to assure accuracy and proficiency. This also reduces the amount of time necessary to process the sample. 3) Service provider should provide an online requisition that already has a history of the patients previously tested. 4) Service provider must have an online system that can be modified to add test. After discussion of a patient's testing needs, sometimes test are added to the same sample and the service provider would need to have a mechanism to accept edits to requisitions. 5) Accurate and reliable data to assure proper diagnosis and treatment of patients. 6) Accessible communication with the service provide regarding test results. d. Government Responsibilities: 1.) Patient samples will be provided to the service provider. 2.) Sample will be label with patient name and the Hematology Branch Account number and bar coded. 3.) All patients testing will be monitored and documented as they are submitted for testing. 4.) Medical staff with assure proper volume or concentration is submitted to the service provider 5.) Staff will prepare the sample according to the protocol defined for the test 6.) Staff will assure that sample is sent within the restricted time defined. 7.) The medical staff at NIH will evaluate the data received and treat patients based on this data as described in the clinical protocol. Reports will be reviewed for consistency and accuracy and if a discrepancy or inconsistent result is found, the service provider will be notified. 8.) All patients testing will be monitored and documented in patient medical record. e. Reporting Requirements and Deliverables: 1.) The medical staff will monitor the progress of the testing and the timeliness. 2.) Service provider will FAX, securely email or send by courier or postal service the results of the testing within a month of sending the sample. 3.) Requisition logs are monitor, generated and managed by Hematology Branch staff weekly. 4.) Completed requisitions are monitor and managed by Hematology Branch staff as necessary. 5.) Results of the test are due within a month of sending the sample. 6.) The testing costs and quantity will be evaluated or enumerated on a monthly basis. 7.) Reports and financial records will be reconciled by the Hematology Branch Staff Assistant. f. Capability statement/Information sought: Based on the responses received from this SOURCES SOUGHT announcement, the proposed acquisition may be solicited as a Total Small Business Set-Aside. All eligible small business concerns responding to this Sources Sought Announcement must have the capabilities to provide services stated above. Interested small business firms are highly encouraged to respond to this notice. However, firms should understand that generic capability statements are not sufficient for effective evaluation of their capacity and capability to perform the work required. Responses must directly demonstrate the company's capability, experience, and ability to marshal resources to effectively and efficiently perform the objectives described above and include an outline of previous or similar projects so that the Government can perform a proper evaluation of the company's capability. Information regarding respondents': (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information; The written response to this notice should consist of the following items: a. Company Name. b. Company DUNS number. c. Company point of contact, mailing address, telephone and fax numbers, and website address d. Name, telephone number, and e-mail address of a company point of contact who has the authority and knowledge to clarify responses with government representatives e. Date submitted. f. Applicable company GSA Schedule number or other available procurement vehicle. g. Do you have a Government approved accounting system? If so, please identify the agency that approved the system. h. Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the Central Contractor Registration (CCR). All respondents must register on the CCR located at http://www.ccr.gov/index.asp i. Not to exceed 20 singled-sided pages (including all attachments, resumes, charts, etc.) presented in single-space and using a 12 point font sized minimum, that clearly details the ability to perform the aspects of the notice described above. All proprietary information should be marked as such. Statements should also include an indication of current certified business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible business concern's name and address). Responses will be reviewed only by NIH personnel and will be held in a confidential manner. j. Common cutoff date: 4/19/2013 8:00 a.m. eastern time l. Delivery point: Submitted (via email) to Deborah Coulter, Contract Specialist at coulterd@nhlbi.nih.gov in MS Word or Adobe Portable Document Format (PDF). All responses must be received by the specified due date and time in order to be considered. 3. Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality - No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-CSB-(SBSS)2013-110-DDC/listing.html)
- Place of Performance
- Address: NIH, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN03030210-W 20130407/130405234553-1394295a74555da8726eaa9f8bed8918 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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