SPECIAL NOTICE
B -- SPECIAL NOTICE INTENT TO AWARD TO MEDSTAR HEALTH RESEARCH INSTITUTE - LIMITED SOURCE JUSTIFICATION
- Notice Date
- 2/3/2017
- Notice Type
- Special Notice
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Agricultural Research Service - Eastern Business Service Center
- ZIP Code
- 00000
- Solicitation Number
- AG-32SC-S-17-830363
- Archive Date
- 2/24/2017
- Point of Contact
- Lisa M. Botella, Phone: 215-233-6555
- E-Mail Address
-
LISA.BOTELLA@ARS.USDA.GOV
(LISA.BOTELLA@ARS.USDA.GOV)
- Small Business Set-Aside
- N/A
- Description
- LIMITED SOURCE JUSTIFICATION FOR AWARD TO MEDSTAR HEALTH RESEARCH INSTITUTE, INC. NOTICE OF INTENT TO AWARD AN INDEFINITE DELIVERY, INDEFINITE QUANTITY (IDIQ) CONTRACT WITH MED-STAR HEALTH RESEARCH INSTITUTE IN HYATTSVILLE, MD TO CONDUCT STUDIES AND PROVIDE MEDICAL SERVICES FOR HUMAN SUBJECTS AND FOR THE REVIEW OF HUMNAN RESEARCH OUTLINED THROUGH AN INSTITUTIONAL REVIEW BOARD (IRB) WITH MEDICAL PERSONNEL TO SUPPORT THE HUMAN NUTRITION REASEARCH CENTER, LOCATED IN BELTSVILLE MD. This firm, fixed price IDIQ is for a Base one (1) year period plus four (4) one-year option periods. There is no funding on the IDIQ. A requisition will be submitted by the location to issue an individual Delivery Task Order for any related IDIQ services and will be the mechanism for funding. These services are estimated at approximately $30,911 per year; for a total for the life of the contract is estimated at $154,553. Additional services may be added to the IDIQ if required and similar to the existing scope of work. The USDA, Agricultural Research Service (ARS), intends to negotiate solely with Med-Star Health Research Institute, herein referred to as "Med-Star" and located in Hyattsville, Maryland to conduct studies and provide medical services for human subjects and for the review of human research outlined through an Institutional Review Board (IRB) with medical personnel to support the USDA, ARS, Human Nutrition Research Center (HNRC) located in Beltsville, MD. Sole Source Justification - MedStar currently maintains three (3) Institutional Review Boards (IRB) that can provide timely service to USDA. The IRB must be registered with the appropriate federal agency and comply with 21 CFR part 56. The IRB must have a Federal-wide Assurance (FWA) in order to demonstrate that it commits to comply with the requirements in the US Department of Health and Human Services Protection of Human Subjects regulations at 45 CFR part 46. MedStar is uniquely qualified to provide medical personnel (licensed physicians and allied health professionals) with research experience to support the Agency's research program. MEDSTAR'S RESPONSIBILITIES: MedStar Health Research Institute (MedStar) through one of its local Institutional Review Boards (IRB) will review of research protocols including initial reviews of protocols, amendments, continuing reviews, emergency reviews, and closure of protocols. MedStar will review these protocols through a regular schedule and provide access to out-of-cycle emergency review. The IRB must be registered with the appropriate federal agency and comply with 21 CFR part 56. The IRB must have a Federal-wide Assurance (FWA) in order to demonstrate that it commits to comply with the requirements in the US Department of Health and Human Services Protection of Human Subjects regulations at 45 CFR part 46. These services include reviewing and approving research protocols and obtaining informed consent forms required for human research. Once the IRB approves the protocol, another IRB will not perform the work due to liability of the IRB Requirements and confidentiality issues. It is imperative that the research be conducted using the same methods so as to not invalidate the study and research. Therefore, using another Contractor would result in duplication of efforts and increasing the cost without any acceptable outcome. MedStar shall provide medical doctors and nurses required for necessary for performing procedures outlined in research protocols approved by the IRB including for example, but not limited to, measures of glucose metabolism, collection of biopsy material, and other medical procedures. MedStar will verify that all medical doctors and nurses will have the appropriate certification or licensure as required in the State of Maryland, to support the conduct of studies with human subjects included but not limited to screening and monitoring the health status of study volunteers, and assume liability for work performed during evaluation and screening of potential subjects, and during sample collection processes when conducted by MedStar's personnel. Use of medical personnel is important because most research protocols require a licensed physician (or other licensed medical professional) to review medical charts and make determinations of health and diagnosis of disease. Communication of disease findings to individuals must be only performed by state-licensed individuals (i.e., physicians) to avoid the practice of medicine without a license. Once the IRB provides approval to initiate a research protocol, it is imperative to have appropriate medical personnel available to review medical charts while meeting the standards set forth to protect the privacy and confidentiality of research volunteers as set forth in 45 CFR 46.111(a)(7) and 21 CFR 56.111 (a)(7). Since MedStar would be providing protocol review and approval, their medical personnel would be permitted and have appropriate training to have confidential access to medical charts for review. Thus, it is necessary for the protocol review and medical support personnel be provided by the same vendor. MedStar uniquely can provide IRB services and medical oversight and has done so for at least the last three (3) years. Each Task Order shall identify the IRB research protocol to be used, the date for delivery of the services, and any limits on the medical staff hours and funding. The Contractor shall not exceed these limits. The Contracting Office will issue a modification if needed to extend the term or increase/decrease the funding available on this Delivery Task Order. In addition, all other terms and limitation of the Contractor's standard commercial warranty or warranties shall be available to the Government for the services acquired under this contract and any issued Delivery Task Order approved by a Contracting Officer. This IDIQ also provides authorization for placing oral orders for services from an approved Authorized Representative (AR) from the Department of Agriculture, Agriculture Research Service. The Contracting Officer shall provide a copy of the Designation Letter to the individual(s) appointed as an AR. Oral orders for services shall not be accepted by the Med-Star or paid by USDA, ARS, unless the AR has been authorized in writing with a Delegation Letter. The overall minimum for this contract is $2,500. This guaranteed minimum will be met with the issuance of individual Task Orders. The overall maximum for this contract is $154,553; however, this is not a guarantee, but may be possible with issuing the four (4) Option Periods on this contract. A Task for Services may be requested by an Authorized Representative (AR) as long as funding has been established and it is followed-up with a confirming order in writing by a warranted Contracting Officer. The AR shall forward the request for service along with an IAS Requisition will be sent to a Warranted Contracting Officer to issue a confirming Delivery Task Order. Should the projected services listed exceed the quantity or amount funded, MedStar shall not perform the service. MedStar will immediately notify both the TR and CO by email requesting approval of the new work. Any work performed beyond the awarded levels without the written consent of a Contracting Officer, will be at MedStar's own risk. As such, the work will not be reimbursed. DOCUMENTATION -Shall identify the IDIQ Contract Number and the Task Order Number and any other pertinent information. INVOICING - shall identify the IDIQ Contract Number and the Task Order Number; a current date, company invoice number, a copy of the approved IRB Authorization letter, the Principal Investigators Name (ARS) and the Principle Investigator at MedStar. Invoicing shall be issued in arrears after the month in which the services were performed and processed through the Invoice Processing Platform (IPP) System. WARRANTY - Med-Star shall provide a copy of their standard warranty (if applicable) to the CO. USDA, ARS SHALL: Prepare research protocols, informed consent forms, and all other documentation required to conduct human research in support of ARS's mission. ARS will respond to stipulations (requests for revisions to protocols and consent forms) from the MedStar IRB, and ARS provide timely submission of protocols, continuations and terminations. Provide the necessary desk space and facilities for chart review for the medical staff provided by MedStar. If any procedures are needed for a research project, ARS will provide all equipment and space required for said procedures. Estimated work includes the following estimates for this requirements: 4 new submissions to the IRB (1 full board, 3 expedited), 4 expedited amendments, 15 protocol continuation (14 expedited and 1 full board) reviews, and 2 expedited protocol terminations will be submitted. In addition, it is anticipated that 92 hours of medical support (46 hours for the medical doctor and 46 hours for the nurse practitioner) will be required. These projections will be reviewed quarterly by the ARS Technical Representative (TR). Should a revision to these services or additional services be required, the TR will notify the Contracting Officer (CO) of the changes needed and a bilateral modification will be issued to MedStar by the CO. Work shall not begin until the bilateral modification is signed by both parties. Provide a list of Authorized Representatives (AR's) who will contract MedStar and Request the Services for each Task Delivery Order. Should the projected services listed exceed the quantity or amount funded, the TR shall not place any additional request for services from MedStar. The TR will immediately notify by email both the Contracting Officer (CO) and the MedStar Representative and state that no further services are to be performed on Item(s) Numbered until a modification is processed. If the TR is requesting an increase in the quantity or amount of any line item, send an email to the CO and MedStar informing them of the modifications required (by line item and description). The TR shall provide documentation and submit through appropriate channels to modify the order. NOTE: Any work requested beyond the awarded (approved) levels without the written consent of a Contracting Officer, will be at the Requestor's own risk. As such, the work will not be reimbursed. The NAICS is 541712 with a size standard of 1,000 employees. This procurement is unrestricted. This is not a request for proposal. No solicitation is available. All responsible sources may submit a capability statement and financial capacity statement, proposal, or quotation. Companies with the demonstrated capability and financial capacity to provide this service must submit a written substantive statement outlining the Company's and service capabilities, including their Institutional Review Board and procedures; hourly rates for the medical and nursing staffing and any consumables price list. which shall be considered by the agency. This announcement and any other documents related to this procurement will be available electronically at the Internet site http://www.fbo.gov. The Contractor is responsible for monitoring the FBO website for information relating to this requirement. Offeror's will be responsible for downloading their own copy of these documents. Contractors are required to acknowledge receipt of all Amendments (if any). If no affirmative responses are received with 7 calendar days of publication of this notice to determine whether a qualified source is more advantageous to the Government, a contract will be placed with Med-Star Health Research Institute under the authority of FAR 6.302.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/0e57e285c1f4872003a82914ce77a667)
- Place of Performance
- Address: USDA, ARS, NEA, HUMAN NUTRITION RESEARCH CENTER, BARC-East, Bldg. 307B, Rm 231, 10300 Baltimore Avenue, Beltsville, Maryland, 20705-2325, United States
- Zip Code: 20705-2325
- Zip Code: 20705-2325
- Record
- SN04390523-W 20170205/170203234225-0e57e285c1f4872003a82914ce77a667 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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