PreSol_Notice.pdf

Pre-Solicitation Notice of Intent.

Date: March 10, 2020 SOLICITATION NUMBER: 75N95019R00076

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

Introduction: This is a Pre-Solicitation Notice. 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 current Clinical Services and Resources Support contract (75N95019C00033) was awarded in 2019 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 organizations 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 as applicable. The Contractor shall ensure that the clinical staff working on this contract maintain professional licensure, including but not limited to Basic Life Support (BLS) and Advanced Life Support (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 staff 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, 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.

Offerors shall designate primary contacts and alternates for billing errors, participant scheduling issues and emergency room diversions in their written technical proposals. It is critical that these contacts or alternates respond to issues in a timely manner (e.g. billing errors- 2 days; scheduling issues – 1 day; emergency room diversion resolution- 1 hour). The Contractor’s primary contacts and alternates must be assigned for the duration of the contract and may not be replaced or removed without prior notification to the Contracting Officer. A comparable replacement must be chosen in accordance with Section G, Article G.2. Key Personnel, HHSAR 352.237-75.

Primary Contact or Alternate’s Responsibilities Response Time Emergency Room access and diversion concerns 1 hour Consulting appointment scheduling 1 day Billing errors 2 days Other issues 1 day

Due to the critical nature of patient care, the contractor must notify the NIDA IRP 6 months in advance if they are no longer able to provide services for any reason.

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 by the Office of the Clinical Director 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. The NIDA IRP maintains laboratory data in Human Research Information System (HuRIS). The 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 operated and maintained by the NIDA IRP Biomedical Informatics Section and the Contractor is not expected to provide any technical support of HuRIS. In addition, the Contractor must provide all supplies and ancillary services necessary to conduct various tests in the Contractor's facilities.

4. Medical Equipment and Supplies Support: The Contractor will provide a mechanism to obtain necessary medical equipment, supplies and services for the clinical research program in the BRC. This includes, but is not limited to, medication, phlebotomy supplies, laboratory specimen supplies (test tubes, urinalysis supplies), IV maintenance supplies to support approximately five clinical study sessions/day that require these supplies. In addition, there may be special procedures supplies that would be pre-specified between the Contractor and the Office of the Clinical Director.

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. The unit must be located within a ten-mile radius of the BRC. 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.

6. Services to be Performed: The facility should include technicians and nursing staff who will be required to complete the NIDA IRP training to use HuRIS and enter the system monthly to maintain access. 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. These assessments will be performed directly into a NIDA-provided computer terminal equipped with NIDA Clinical Data Warehouse (CDW) software. NIDA will provide Clinical Research Unit (CRU) staff with training in the use of this software and assure VPN authorization by end users. Contractors must login and use the system every month to retain clinical access. Nurses must maintain login credentials.

4. Any vital signs required by the protocol will also be recorded directly into CDW software on the NIDA computer.

7. Option Quantities for 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.

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.

Note: Transition-In services are applicable to the Base Period only. Offerors shall price Transition-In services as a separately-priced option quantity (Transition-In services are not anticipated for the incumbent). Transition-Out services are applicable to all other option periods. Offerors shall price Transition-Out services as a separately-priced option quantity.

Transition-ln Services: Transition-ln Services shall occur from date of award and shall last an estimated 30 days. The Contractor shall develop a Draft Transition-ln Plan that shall facilitate the accomplishment of a seamless transition from the incumbent to an incoming contractor/Government personnel. The Draft Transition-Out Plan shall be submitted with the offeror's written technical proposal. The Draft Transition-ln Plan shall identify points-of-contact (POC) for liaison between the Government, the prime contractor, and other contracted industry partners to ensure a proper and orderly transition and transfer of services and assets between the parties cited. The Draft Transition-ln Plan shall communicate the Contractor's transition strategy in the Contractor's written technical proposal. The Final Transition-ln Plan shall reflect any changes, additions, or revisions as required by NIDA and shall be delivered no later than three working days after the Contract Kick-Off Meeting.

Transition-Out Services: Transition-Out Services shall occur within 120 days of contract expiration and shall last an estimated 60 days. The Contractor shall develop a Draft Transition-Out Plan that shall facilitate the accomplishment of a seamless transition from the incumbent to an incoming contractor/Government personnel at the expiration of the contract. The Draft Transition-Out Plan shall not be submitted with the offeror's written technical proposal. The Contractor shall provide the Contracting Officer's Representative (COR) with the Draft Transition-Out Plan no later than 90 days prior to the expiration of the contract. The draft Transition-Out Plan shall be submitted electronically via email to the

COR.

The Contractor shall identify how it will coordinate with the incoming contractor and/or Government personnel to transfer knowledge regarding the following:

1. Program and project management processes;

2. Points of contact (includes Key Stakeholders and Points of Contact);

3. Location of technical, program and project management documentation and software tools;

4. Status of ongoing technical initiatives;

5. Appropriate contractor to contractor coordination to ensure a seamless transition;

6. Transition of Key Personnel;

7. Identify schedules and milestones;

8. Identify actions required of the Government; and

9. Establish and maintain effective communication with the incoming contractor/Government personnel for the period of the transition via weekly status meetings.

The Draft Transition-Out Plan shall include, but is not limited to:

1. Coordination with Government representatives;

2. Review, evaluation, and transition of current support services;

3. Transition of historic data to new contractor systems;

4. Transfer of all necessary business and/or technical documentation;

5. Orientation phase and program to introduce Government personnel, programs;

and users to the contractor's team, tools, methodologies, and business processes;

6. Disposition of contractor-purchased Government owned assets, including facilities, equipment, furniture, phone lines, computer equipment, etc.;

7. Transfer of Government Furnished Equipment (GFE) and Government Furnished Information (GFI), and GFE inventory management assistance; and

8. Personnel out-processing procedures, turn-in of all Government keys and ID/access cards.

Upon receipt of Government approval of the Draft Transition-Out Plan, the Contractor shall execute the Final Transition-Out Plan within 30 days.

8. Additional Option Quantities: The requirements for the clinical services are subject to change.

Participant census can change significantly depending on the direction of the research and number or active clinical investigators. New protocol may require more medical supplies, more labs, or may utilize a new position. This impacts the labor, supplies and services requirements for clinical care. In order to accommodate changing requirements in a timely manner the contract also includes the following option quantities:

Option Task or

Quantity

Description

Maximum Quantities Per Contract Period

Estimated Effort

– Dollars

A Laundry Services

2 times per period of performance.

TBD

The Contractor shall provide laundry services (sheets, blankets, hospital gowns, towels, wash cloths, pillow cases, bath blankets).

B

Supplemental Nursing 10 times per period of Performance

TBD

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. This nursing coverage may include evening and weekend hours and will be located at the BRC. Registered Nurses (RNs) will be required to perform the duties outlined below. All nurses will be credentialed through the Contractor but will have all the NIDA-IRP specific training necessary to function in the clinical areas of the NIDA IRP. NIDA IRP will provide this training to the successful offeror at the time of award. The Contractor will be provided approximately five business days’ notice when a Contractor nurse will be needed. The Contractor 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. The Contractor 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 operated and maintained by the NIDA IRP Biomedical Informatics Section and the Contractor is not expected to provide any technical support of HuRIS.

4. All clinical staff need to maintain BLS and ALS training for the duration of the contract.

The Contractor will cover the cost of these trainings.

C MRI Technician Support (Full Time) 1 TBD

Allowable Overtime (40 hours per period)

The Contractor shall provide a licensed MRI technician to operate a 3T Siemens Prisma scanner and Bruker Biospin 9.4 T scanner operating on a ParaVision 6.0.1 platform for both human and animal research utilizing both structural and functional MRI in the BRC. The Contractor shall execute projects focusing on reproducibility and quality assurance of different pulse sequence and activation paradigms with the assistance of a government Magnetic Resonance physicist. The Contractor shall also ensure that all human and animal subject experiments are conducted in compliance with applicable NIH standards and regulations. This position is full-time.

The Contractor shall supply supplemental MRI technical support services to augment the current federally employed MRI technician(s) of the NIDA IRP. If adequate MRI technical coverage is not available because of extended sickness, vacation, or other reasons, it is the responsibility of the Contractor to provide MRI technicians to augment or fill-in to provide the required coverage. This coverage may include evening and weekend hours and will be located at the BRC.

D

MRI Technician Support (Part Time) Allowable Overtime (40 hours per period)

1 TBD

The Contractor shall provide a licensed MRI technician to operate a 3T Siemens Prisma scanner and Bruker Biospin 9.4 T scanner operating on a ParaVision 6.0.1 platform for both human and animal research utilizing both structural and functional MRI in the BRC. The Contractor shall execute projects focusing on reproducibility and quality assurance of different pulse sequence and activation paradigms with the assistance of a government Magnetic Resonance physicist. The Contractor shall also ensure that all human and animal subject experiments are conducted in compliance with applicable NIH standards and regulations. This position is part-time.

The Contractor shall supply supplemental MRI technical support services to augment the current federally employed MRI technician(s) of the NIDA IRP. If adequate MRI technical coverage is not available because of extended sickness, vacation, or other reasons, it is the responsibility of the Contractor to provide MRI technicians to augment or fill-in to provide the required coverage. This coverage may include evening and weekend hours and will be located at the BRC.

E Nutrition 1 TBD

The Contractor will provide nutritional supplies to research participants.

Set-Aside Status: N/A

Anticipated Period of Performance:

Period of Performance: The contract performance for this requirement includes one (1) 12-month base period, four (4) 12-month option periods, and additional Option Quantities.

Options may or may not be exercised at the unilateral discretion of the Government. Should all option periods be exercised, the contract will have a total duration of five years.

Anticipated Contract Type:

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.

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. 75N95019R00076 will be available electronically on or about March 25, 2020. The RFP shall be accessible through the site https://beta.sam.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 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.

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