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Clinical Services and Resources for the National Institute on Drug Abuse Intramural Research Program

Maryland, United States
Government : Federal
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PROJECT TITLE: Clinical Services and Resources for the National Institute on Drug Abuse Intramural Research Program

THIS IS NOT A REQUEST FOR PROPOSALS, ABSTRACTS, OR QUOTATIONS. This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. The Government does not intend to award a contract based on responses under this announcement nor otherwise pay for preparing any information sent for the Government's use. Any proprietary information should be so marked.

The purpose of this notice is to obtain information regarding:

1. The availability and capability of any qualified small business or other-than-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 disadvantaged businesses; and
3. Their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition.

The applicable NAICS code for this acquisition is 622110 - General Medical and Surgical Hospitals. Responses to this notice will be accepted from all businesses under this NAICS code. Responses should clearly state whether the respondent is considered a small or other-than-small business under this NAICS code.

Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible.

Background Information:
The mission of the National Institute on Drug Abuse (NIDA) Intramural Research Program (IRP) is to conduct state-of-the-art research on basic mechanisms that underlie drug abuse and addiction, and to develop new methods for the treatment of drug abuse and addiction. Research is supported at the molecular, genetic, cellular, animal, and clinical levels and is conceptually integrated, highly innovative, and focused on major problems in the field. The long-term goal of the research is to better understand the biological and behavioral factors contributing to initiation, maintenance, and elimination of drug abuse and addiction (and associated diseases), and to translate this knowledge into improved strategies for preventing, treating, and reducing the negative consequences for the individual and for society caused by drug abuse and addiction.

Purpose and Objectives for the Procurement:
The purpose of this potential requirement is to provide the NIDA IRP with clinical care support services and resources necessary to maintain the research operation of the NIDA IRP Clinical Research Program.

Project Requirements:
The NIDA IRP requires the following Clinical Research Program support services and resources:

1. Management of Personnel and Contract Administration
It is the responsibility of the Contractor to ensure adequate staffing and supervision of staff. The Contractor shall ensure that the clinical staff working on this contract maintain professional licensure, including but not limited to Basic Life Saving (BLS) and Advanced Life Saving (ALS) training. The Contractor must maintain any other professional responsibilities and abide by a professional code of conduct. The Government may provide specialized training for contractor staff on a case-by-case basis. Contract administration shall oversee the performance of the contract in terms of customer satisfaction. The Contractor shall review budgeted hours and costs versus actual expenditures, and report any or all issues to the Contracting Officer's Representative (COR). The Contractor will handle all contract financials and will provide data to the COR. This includes monitoring of hours, travel costs, billing, and reconciliations. In addition, the Contractor will coordinate the timely submission of contract deliverables to the COR. The Contractor shall provide management of personnel and contract administration services from the Contractor's site.

2. Medical Consultation
Approximately 500 participants are involved in one or more research protocols per year at the NIDA IRP. The Contractor shall provide the equipment, supplies, and ancillary services necessary to conduct medical consultations and rare emergency medical care (i.e., transportation to emergency room). Specifically, the Contractor shall provide 1) Urgent or non-routine medical consultation services for participants who are identified with a medical condition upon screening, and 2) On-call cardiology consultation.

3. Diagnostic Laboratory and Other Testing Services
The Contractor shall provide necessary diagnostic laboratory and radiology services as requested for the clinical research program. The Contractor shall provide all equipment as well as software to allow electronic transfer of laboratory data (ordering and results) between the Contractor and the NIDA IRP. In addition, the Contractor must provide all supplies and ancillary services necessary to conduct the radiology, neuroradiology, and laboratory tests.

4. Supplies and Pharmacy Support
The Contractor will provide a mechanism to obtain necessary medical equipment and supplies for the clinical research program in the Biomedical Research Center (BRC). This includes laundry services (sheets, blankets, hospital gowns), phlebotomy supplies, laboratory specimen supplies (test tubes, u/a supplies), IV maintenance supplies to support approximately five clinical study sessions/day that require these supplies, and light snacks and beverages.

5. Domiciliary Oversight and Care
The Contractor shall provide overnight stay capability in a facility that can accommodate NIDA participants. NIDA anticipates approximately 12 overnight stays per month, however, this can fluctuate depending on the clinical protocols currently running.

6. Nursing Services
At times, the Contractor may be required to provide specialized nursing services for those individuals participating in protocols that require consecutive night's accommodations. Specialized nursing services will include:

1. Administration of research drugs and/or medications as dictated by NIDA-approved study procedures.
2. Collection, processing and storage of biological specimens. Proper storage container will be provided by NIDA.
3. Collection of neuropsychological and other forms of behavioral assessments as defined by the research study design.
4. Any vital signs required by the protocol will also be recorded directly into Clinical Data Warehouse (CDW) software on the NIDA computer.
7. Supplemental Nursing
The Contractor shall supply supplemental nursing services to augment the three federally-employed nurses of the NIDA IRP. In the event that adequate nursing coverage is not available because of extended sickness, vacation, or other reasons, it is the responsibility of the Contractor to provide Registered Nurses (RNs) to augment and fill in to provide the required coverage.

Contractor's nurses shall perform the following duties:

1. Medical screening of participants

2. Phlebotomy, placement of IVs, and obtaining diagnostic tests (e.g. ECG, breathalyzer, vital signs, urine toxicology, urine pregnancy testing, breath CO). Assisting with experimental sessions (pre-session procedures, session monitoring and post-session procedures).

3. Contractor's clinical staff will be granted access to this system and will be expected to document participant and study information, as required. The clinical staff will be required to complete NIDA IRP-specific training requirements to access HuRIS. HuRIS is an electronic clinical records system operated and maintained by the NIDA IRP Biomedical Informatics Section and the Contractor is not expected to provide any technical support of HuRIS.

4. Nursing staff need to maintain BLS and ALS training for the duration of the contract. The Contractor will cover the cost of these trainings.

8. Pharmacy Services

The Contractor is required to provide a licensed pharmacy technician to support the NIDA pharmacy. The technician will support the NIDA pharmacy with the following tasks:

1. Maintaining scheduled and non-schedules drugs;

2. Communicating with NIDA physicians, physician's assistants, and nurses' orders are placed;

3. Attending meetings, seminars, conferences held at NIDA IRP.

9. Statistical Support
The Contractor shall provide the following statistical support using personnel with appropriate credentials and experience, i.e. clinical research, technical and administrative expertise.

10. Biostatistical Support
The NIDA IRP Clinical program requires senior biostatistician support. The Contractor shall provide this support to review protocols under development or during scientific review by a Ph.D. level contractor biostatistician. Final decision regarding protocols will be made by the NIDA Investigator.

11. Data Safety and Monitoring Board (DSMB) Support
The DSMB is an independent group of experts that advises NIDA IRP and the NIH IRB. Members are experts in their field and their expertise is relevant to the research conducted at the IRP (e.g., clinical, pharmacological, etc.). DSMB Members evaluate/review approximately three clinical protocols quarterly for participant safety, scientific validity and study progress. The Contractor shall provide at least three doctoral level members with the required expertise to serve in this function.
12. Transition Services
The Contractor shall perform transition services necessary to ensure an effective transition-in and transition-out of contractor support and continued operations, as well as an orderly transition period without any interruption or loss of proficiency of services.

Mandatory Criteria:

1. The facility must be located within a ten-mile radius of 251 Bayview Boulevard, Baltimore, MD 21224.
2. The facility must be properly secured to ensure participant safety and protocol compliance; this includes ensuring participant abstinence from drugs of abuse (and sometimes nicotine) per specified protocol requirements.
3. The facility must allow NIDA Federal medical doctors (MDs) to provide medical and/or research care.
4. The facility must have the flexibility to allow the NIH Institutional Review Board (IRB) to be the IRB of record.

Anticipated Period of Performance:
The anticipated period of performance is one six-month base period and nine (9) six-month option periods, with additional option quantities.

Capability Statement/Information Sought:
Contractors that believe they possess the ability to provide the services and resources described above should submit documentation of their ability to meet each of the project requirements to the Contract Specialist.

1) Experience: An outline of pervious clinical support projects that are similar to the project requirements in which the organization and proposed personnel have participated;

2) Personnel: The total number of employees and the professional qualifications of medical and support personnel as it relates to the above outlined requirements;

3) Facilities: A description of general and specific facilities and equipment available;

4) Mandatory Qualifications: A clear outline of the offeror's ability to meet the mandatory criteria detailed above.

Any other specific and relevant information about this particular area of procurement that would improve our consideration and evaluation of the information presented is desirable.

Interested organizations should demonstrate and document, in any capability statements submitted, extensive experience with and the ability to perform all of the above tasks. Additionally, NIDA is interested in receiving capability statements from organizations with the ability to perform some, but not all of the above tasks.

Documentation may include, but not be limited to, contracts both Government and commercial the organization performed, references, i.e., names, titles, telephone numbers and any other information serving to document the organizations capability, e.g., awards, commendations, etc.

All capability statements must provide the following: 1) company name, address and DUNS number; 2) point of contact, 3) phone/fax/email; 4) NAICS Codes; 5) business size and status; 6) capability information in response to the requirement and qualifications identified in this notice; and 7) type of small business your organization classifies itself as, if applicable. Capability statements must be submitted electronically via email to NO LATER THAN September 27, 2019 at 10:00 AM (EST). Electronic capability statements will be accepted in the form of a single PDF file with the subject line: "Capability Statement75N95019R00076".

Primary Point of Contact:
Polina Klimenkova, Contract Specialist

Secondary Point of Contact:
Andrew R. Hotaling, Contracting Officer

THIS NOTICE IS NOT A REQUEST FOR PROPOSALS. This notice is for information and planning purposes only and does not obligate the Government to award a contract or otherwise pay for the information provided in this response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. 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). 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 the subsequent solicitation.

Polina Klimenkova, Phone 301-827-6848, Email

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