SOLICITATION NOTICE
R -- Continuity of NIDA IRP Clinical Protocol Participant Recruitment Support Services
- Notice Date
- 5/1/2015
- Notice Type
- Presolicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support/Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, Maryland, 20892
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-SSSA-NOI-15-331
- Archive Date
- 5/23/2015
- Point of Contact
- Lauren M. Phelps, Phone: 3015942490
- E-Mail Address
-
lauren.phelps@nih.gov
(lauren.phelps@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- INTRODUCTION This is a pre-solicitation non-competitive (notice of intent) synopsis to award a contract without providing for full or open competition (including brand-name). THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The National Institute on Drug Abuse (NIDA), Consolidated Station Support and Simplified Acquisitions (CSS/SA) Branch intends to negotiate and award a purchase order to Matthews Media Group, Inc. for continued participant recruitment support services without providing for full and open competition (including brand-name). NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541990 with a Size Standard of $14 Million. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-81 dated April 10, 2015. This acquisition is for a commercial item or service and is conducted under the procedures as prescribed in FAR Subpart 13 - Simplified Acquisitions. This acquisition is NOT expected to exceed the simplified acquisition threshold. STATUTORY AUTHORITY This acquisition is conducted under the authority of the authority of FAR Subpart 13.106-1. DESCRIPTION OF REQUIREMENT Purpose and Objectives The purpose of this requirement is to provide the NIDA IRP with continuity of participant recruitment support services necessary to maintain the operation of the NIDA IRP Clinical Research Program while the requirement completes the final stages of re-competition. Project Description Independently and not as an agent of the Government, the Contractor shall provide services and materials for the following tasks: 1. Project Management The Contractor shall provide sufficient project management support to ensure adequate staffing and any supervision of that staff as necessary for smooth daily operations of recruitment activities. This effort shall oversee staffing the call center, providing for in-person screening, and managing the flow of participants throughout the day. Project management support shall also provide for the reporting requirements of this contract as detailed in the deliverables section of this statement of work. Finally, the contractor shall be responsible for proper invoicing. In particular, the contractor shall ensure the inclusion in all invoices of costs associated with the participant screening process, such as participant transportation and meals, if needed, as well as the staffing hours, ads developed and run, and tracking of participant remuneration. 2. Advertisement Support The NIDA IRP is based in Baltimore, MD and clinical protocol participants must only be recruited from the Baltimore, MD and Washington, DC areas. The Contractor shall provide general advertising support to include posting advertisements to Craigslist, generally up to six IRB approved postings two or three times weekly. The Contractor shall also manage the NIDA IRP recruiting website which is hosted by NIH. The Contractor shall additionally provide specific advertising support several protocols, as required. This specific support shall include ad placement in local newspapers, buses, radio, and some web advertising such as Craigslist. The NIDA IRP will provide prepared advertisements for placement for this purpose. 3. Participant Screening The Contractor shall perform participant screening in two phases: 1) telephone interviews and 2) in-person screening. a. Telephone Screening The NIDA IRP currently conducts roughly 350 telephone screening interviews per month. All potential clinical research program participants must successfully complete telephone interviews. Telephone interviews are structured and shall be performed by the contractor using IRB-approved scripted language. Interviews are computer based, and the contractor shall ensure accurate and timely electronic data entry of pertinent information into the HuRIS electronic medical record system. For this purpose, the contractor shall be proficient in communicating effectively with drug user populations while assessing their histories and needs, interpreting the data in the context of the current epidemiology and natural history of drug use, misuse, addiction and treatment for appropriate referral to research opportunities. The contractor shall generally provide for telephone screening support Monday through Friday from 8:30 AM to 6:00 PM. Hours may vary slightly due to timing of advertisements; for example, a radio ad run during a baseball game would require a flexible work schedule to ensure that staff is available to answer the phone as soon as the ad runs. This may be managed by allowing some contractor personnel to arrive later in the day; overtime shall not be approved for this function. b. In-Person Screening The contractor shall offer all potential participants successfully completing telephone interview screens an appointment for in-person screening. The contractor shall then schedule and perform the in-person screening. Informed consent must be obtained from each participant for screening protocol and procedure including completion of appropriate screening instruments. Generally, in-person screening takes six to eight hours and is conducted in one day. If in-person screening cannot be completed in one day, the contractor shall schedule additional testing as necessary under the guidance of NIDA IRP research team members. Approximately 100 initial and 100 follow up appointments are scheduled each month. The in-person screening process requires coordination with NIDA IRP staff including but not limited to Physician Assistants, Nurse Practitioners and Physicians. The Contractor shall provide medical assistant support for basic medical assessments including obtaining vital signs, drawing blood, performing ECGs, urine pregnancy testing, CO monitoring, breathalyzer and testing urine for drugs of abuse. The Contractor will also supply the Clinical Laboratory Improvement Amendments (CLIA) waiver testing kits needed for pregnancy, HIV and urine testing for drugs of abuse. The contractor shall assess participant responses during the screening process. Accordingly, the contractor must be knowledgeable in drug use disorders, medical and psychiatric measures, and psychiatric interviewing. The contractor must have strong and professional interpersonal skills to ensure appropriate explanations of the current research protocols for which the participant may be eligible. The contractor shall enter all in-person screening information, from scheduling through screening results, in the HuRIS. Computer proficiency is necessary to ensure proper and accurate recording of participant clinical records. In the event a participant does not qualify for a protocol but desires treatment, the contractor shall use the Substance Abuse and Mental Health Services Administration (SAMHSA) website to make appropriate referrals to community providers for medical and drug treatment as needed during recruitment in coordination with the NIDA IRP research team. The contractor shall also perform structured exit interviews with individuals screened for research participation. 4. Participant Recruitment Administrative Support The Contractor shall be responsible for on-site administrative support relating to the participant recruitment process. Potential clinical research participants visit the NIDA IRP on a regular basis for screening procedures and enrolled clinical research participants visit the NIDA IRP on a regular basis to participate in protocols. The Contractor shall manage the Clinical Research Program front-desk, including the answering of telephones and performance of clerical activities, oversee participant and potential participant check-in and check-out, and assist with the participant remuneration process as well as other project management activities as requested. 5. Participant Remuneration The Contractor shall be responsible for the remuneration of all the NIDA IRP clinical research program participants. In keeping with the NIDA Remuneration Policy, as participants complete sections of a protocol, the contractor shall so indicate in the electronic medical records system, HuRIS. At pre-determined times within each protocol the contractor shall disburse remunerations to participants. The funds may be checks, paying bills for the participant, gift cards or cash as defined by the protocol. The contractor shall ensure that the HuRIS exactly records the funds distributed monthly. The contractor shall also track individual PIs' use of remuneration allowances. In the event that one or more PI(s) approaches his or her allowable remunerations limit or has insufficient funds to pay participants in any given week, the contractor must notify the Clinical Director or his designee, the COR and the alternate COR, and the principal investigator(s) immediately via email. 6. Reporting The Contractor shall provide weekly remuneration reports and a monthly recruitment program, advertising, and IRB reportable events reports. Period of Performance The period of performance shall be May 15, 2015 to June 12, 2015. Type of Contract Contemplated The Government anticipates award of a firm fixed price purchase order. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted. Specifically, Matthews Media Group, Inc. is the only contractor capable of meeting the needs of this requirement in the time frame required. The current contract is being re-competed and is expected to be awarded within the next two months. This requirement is for continuity of services until the new contract is awarded. Matthews Media Group, Inc., the incumbent contractor, currently works closely with each NIDA IRP Principal Investigator to recruit potential participants for their protocols and protocol participants are necessary to ensure that NIDA IRP Clinical Research Program continues until a new recruitment contract is awarded. Presently there are 18 protocols actively recruiting, each with its own set of inclusion and exclusion criteria. Screening for these protocols requires a very detailed working knowledge of all of the studies and the recruitment process. The team of screeners provided by the Contractor has completed the lengthy process of training required by both the NIH and the NIDA IRP to be allowed access to our in-house electronic medical records system. These lengthy training processes are IRB-mandated for the protection of our potential participants. The ramp up necessary to bring in a new Contractor at this time, and for only a period or performance two months or less until a new competitive contract, is awarded, would be unreasonable. Accordingly, use of any other contractor to perform these services on the immediate and short term basis required would be to the significant detriment of ongoing scientific research and is therefore impossible. CLOSING STATEMENT THIS SYNOPSIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received by the closing date and time of this announcement and must reference the solicitation number. Responses may be submitted electronically to Lauren Phelps, Contract Specialist, at lauren.phelps@nih.gov. US Mail and Fax responses will not be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-2/HHS-NIH-NIDA-SSSA-NOI-15-331/listing.html)
- Place of Performance
- Address: Baltimore, Maryland, 21224, United States
- Zip Code: 21224
- Zip Code: 21224
- Record
- SN03717705-W 20150503/150501235003-e8bc5dcd7d43374293f09bc0db09304e (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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