Clinical_Services_PreSol_Notice_final.doc

SOLICITATION NUMBER: 75N95019R00046

NOTICE INFORMATION

Title:

Clinical Services and Resources for the National Institute on Drug Abuse

Intramural Research Program

Introduction:

This is a Pre-Solicitation Notice of Intent. This is NOT a solicitation for proposals, proposal abstracts, or quotations. A solicitation will be issued on a later date.

The purpose of this pre-solicitation notice is to notify potential offerors that the National Institute on Drug Abuse (NIDA) intends to solicit proposals for Clinical Services and Resources support from qualified contractors having the capability to perform the tasks identified in this pre-solicitation notice.

This acquisition is a re-competition of the Clinical Services and Resources Support requirement of the NIDA Intramural Research Program (IRP) Clinical Research Program. The initial Clinical Services and Resources Support contract (HHSN271201400042C) was awarded in 2014 to Johns Hopkins Bayview Medical Center.

Requirement 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 Requirement:

NIDA intends to solicit proposals from qualified businesses 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 Tasks/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. Medical Equipment and Supplies 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:

a. Administration of research drugs and/or medications as dictated by NIDA-approved study procedures.

b. Collection, processing and storage of biological specimens. Proper storage container will be provided by NIDA.

c. Collection of neuropsychological and other forms of behavioral assessments as defined by the research study design.

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:

a. Medical screening of participants

b. 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).

c. 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.

d. 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:

a. Maintaining scheduled and non-schedules drugs;

b. Communicating with NIDA physicians, physician’s assistants, and nurses’ orders are placed;

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

9. 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.

10. 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.

11. 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.

Set-Aside Status:

It is anticipated that the services will be acquired through unrestricted full and open competitive procedures under NAICS Code 622110 - General Medical and Surgical Hospitals.

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.

Anticipated Contract Type:

The NIDA anticipates the award of one (1) contract. It is anticipated that the contract type shall be cost-reimbursement.

Request for Proposal Release Information:

Request for Proposal (RFP) No. NIH-NIDA-SSSA-RFP-14-070 will be available electronically on or about April 15, 2019. The RFP shall be accessible through FedBizOpps at http://fedbizopps.gov. All information required for the submission of a proposal will be contained in or accessible through the RFP package. Responses to the RFP will be due on or about 30 days following RFP release. Offerors must submit a proposal for all Task Areas in order to be considered for award. WE ENCOURAGE ALL RESPONSIBLE SOURCES TO SUBMIT A PROPOSAL WHICH WILL BE CONSIDERED BY THE AGENCY.

Notes: It is the Offeror’s responsibility to monitor the above mentioned site for the release of the solicitation and any amendments.

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. No proprietary, classified, confidential, or sensitive information should be included in your 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.