SOLICITATION NOTICE
R -- Clinical research assistant services
- Notice Date
- 3/17/2005
- Notice Type
- Solicitation Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of the Navy, Bureau of Medicine and Surgery, NMC San Diego, Bldg 1 38400 Bob Wilson Drive, San Diego, CA, 92134-5000
- ZIP Code
- 92134-5000
- Solicitation Number
- N00259-05-T-0027
- Response Due
- 3/23/2005
- Archive Date
- 3/24/2005
- Small Business Set-Aside
- Total Small Business
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the information in FAR 12.6, using Simplified Acquisition Procedures as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; a written solicitation will not be issued. The RFQ number is number N00259-05-T-0027. This solicitation document and incorporated provisions and clauses are those in effect through FAC 2005-01 and DFARS Change Notice 20050222. It is the contractor?s responsibility to be familiar with the applicable clauses and provisions. This is a 100% Small Business Set-Aside. Naval Medical Center San Diego (NMCSD) requests responses from qualified sources capable of providing: CLIN: 0001CLINICAL RESEARCH ASSISTANT for administrative and logistical support of research protocol S-04-0123 in accordance with the statement of work(SOW). QUANTITY: 1920, UNITof ISSUE: HOUR, UNIT PRICE: ________, EXTENDED AMOUNT:________.The period of performance is from 28 March 2005 ? 27 March 2006. STATEMENT OF WORK SCOPE OF WORK. The Contractor shall provide Clinical Research Assistant services in support of Naval Medical Center San Diego, CA. Services shall be performed on site at the Naval Medical Center San Diego (NMCSD). INDEPENDENT CONTRACTOR. The services rendered by the Contractor are rendered in the capacity as an independent Contractor. The Government may evaluate the quality of both professional and administrative services for purposes of contract inspection and acceptance. The Government retains no direct control over professional judgments, diagnoses, or specific treatments. The Contractor shall be solely responsible for any and all liability caused by the acts or omissions of its agents or employees. The Contractor shall not in any manner represent or infer that it is an instrumentality or agent of the United States Government. The Contractor shall recognize that the commanding officer of the MTF maintains administrative and operational responsibility for all activities within the command and may take such actions as necessary to preserve and maintain the integrity of the command, subject to the limitations prescribed by law and U.S. Navy Regulations. MODIFICATIONS. The Contracting Officer will designate and authorize an individual to act as Contracting Officer's Representative (COR). Any such representative appointed will be specifically designated by letter from the Contracting Officer. The COR exclusively represents the Contracting Officer in all technical phases of the work, but is not authorized to issue Change Orders, Supplemental Agreements, or direct any contract performance requiring contractual modification or adjustment. Changes in the scope of work can only be made by modification properly executed by the Contracting Officer. All observations made by persons other than the Contracting Officer or the COR are strictly advisory and shall not influence Contractor operations except for administrative requirements and responsibilities specified herein. BRIEF DESCRIPTION OF SERVICES. The Contractor is required to provide the following services in accordance with the requirements contained herein: Serve as a member, and attend meetings, of the NMCSD?s DoD Spatial Orientation Center (DSOC). Carry out research activities and plans approved by the DSOC. Provide 1920 hours of on-site services at the MTF and at designated research sites as follows: The contractor shall provide coordination of investigators with study site personnel, archiving and file management, scheduling, construction of databases, production of study forms, ensuring tracking and monitoring of adverse drug effects data forms between PI, medical monitor and CID contract specialist, reproduction and filing of special data forms, performing descriptive statistics, and creating summary reports. Contractor will work closely with NMCSD study administrator to administer and conduct the daily operation of the two Command sponsored clinical investigations. Contractor will perform duties at the NMCSD site using government furnished facilities, supplies and equipment. Workload occurs as a result of scheduled and unscheduled requirements. QUALITY OF SERVICE. The services specified in this Work Statement shall be performed in accordance with established principles and ethics of the medical research profession. The quality of health care provided will meet or exceed the current recognized standards established by the Joint Commission on Accreditation of Healthcare Organizations (Joint Commission), the American Hospital Association (AHA) and those other professional associations which specify standards of performance for the medical profession. In all cases, the dignity of the patient will be given the highest regard, and the precepts of the American Hospital Association's "Bill of Rights for Patients" shall be observed. DEFINITIONS ACTIVE DUTY MEMBER. Full-time duty in uniformed service of the United States. This includes full-time training duty; annual training duty; and attendance, while in the active service, at a school designated as a service school by law or by the Secretary of the Military Department concerned. It does not include full-time National Guard Duty. CLINICAL PRIVILEGES. Those elements of medical care which define the scope and limits of practice by a healthcare practitioner in a treatment facility. COMMANDING OFFICER. The individual Naval Officer who has responsibility for the operation of the medical treatment facility for which the contract is providing services. This is the Commanding Officer of the hospital. CONTRACTING OFFICER. The Contracting Officer is responsible for negotiating changes in terms, conditions, or amounts cited in this contract. CONTRACTING OFFICER'S REPRESENTATIVE (COR). The Government employee responsible for assuring Contractor performance through audit, documentation, and liaison with the Contracting Officer. The COR is appointed in writing by the Contracting Officer. The COR has no authority to resolve disputes or obligate funds. CONTRACTOR. That entity or its representative responsible for the delivery of the services or materials specified in this contract, as designated by contract award. CONTRACTOR EMPLOYEE. For purposes of this contract, an individual employed by, or contracted by, the Contractor to provide services under this contract. CREDENTIALING. The overall process of review and evaluation of healthcare providers' professional qualifications and demonstrated current competence for the purpose of granting delineated clinical privileges. The process involves the verification of credentials and observation of clinical skills, recordkeeping, ethics, professional decorum, and participation in staff meetings and professional committees. Input from the QAI/RM program is used in the review and evaluation. CREDENTIALS. Record of education, clinical experience, professional performance and continuing education that confirms that a healthcare practitioner is professionally competent to exercise the clinical privileges granted. Additionally, it includes evidence of the practitioner's physical and mental wellbeing. The term is also used generically to include the clinical privileges granted. CREDENTIALS VERIFICATION. Confirmation from a primary source (granting agency), or a service that confirms credentials, that the information provided by the healthcare practitioner is current and correct and substantiates qualifications. Credentials verification is conducted prior to initial employment of employees. ELIGIBLE BENEFICIARY. Those listed in the Defense Enrollment Eligibility Reporting System (DEERS). EMPLOYEE. See Contractor Employee. JOINT COMMISSION ON ACCREDITATION OF HEALTHCARE ORGANIZATIONS (JOINT COMMISSION). A national organization dedicated to improving the care, safety, and treatment of patients in healthcare facilities; publishers of the Joint Commission Accreditation Manual for Hospitals. QUALITY ASSESSMENT AND IMPROVEMENT/RISK MANAGEMENT. An ongoing program designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, and resolve identified problems. QUALITY ASSURANCE (CONTRACT). Those actions taken by the Government to check goods or services listed on the Performance Requirements Summary to determine that they meet the requirements of the Performance Work Statement. GOVERNMENT FURNISHED PROPERTY AND SERVICES For services performed on-site at NMCSD, the Government will provide to the contractor, without cost, all facilities, utilities, materials, equipment, supplies, and support services currently and normally used to perform the services required by this contract. If the contractor deems that additional Government furnished property or services are required to perform his/her duties, the Government will consider requests for such additional property or services. However, approval by the Government of such requests shall be contingent on available funds, in accordance with the mission of NMCSD and the approval of the Commanding Officer. Denials of requests and/or delays in acquiring any additional property or services shall not be cause for Contractor nonperformance or claims under this contract. Government property and services furnished to the Contractor shall be for the sole purpose of performance of contract requirements. Property and services shall not be removed from the Government installation without notification to and approval by the COR. SPECIFIC TASKS GENERAL PRINCIPLES. The contractor shall perform services consistent with clinical privileges approved by the Commanding Officer. SPECIFIC DUTIES. The contractor shall provide coordination of investigators with study site personnel, archiving and file management, scheduling, construction of databases, production of study forms, ensuring tracking and monitoring of adverse drug effects data forms between PI, medical monitor and CID contract specialist, reproduction and filing of special data forms, performing descriptive statistics, and creating summary reports. Contractor will work closely with NMCSD study administrator to administer and conduct the daily operation of the two Command sponsored clinical investigations. Contractor will perform duties at the NMCSD site using government furnished facilities, supplies and equipment. Workload occurs as a result of scheduled and unscheduled requirements. HEALTHCARE ADMINISTRATION. All records produced in the performance of this contract and all evaluations of patients are the property of, and subject to the exclusive control of, the Government. All requests from other treatment facilities or other individuals for patient records shall be handled in accordance with procedures specified by NMCSD instructions. INFECTION CONTROL. The Contractor shall adhere to hospital custodial guidelines, including those concerning eating and refreshment areas, to maintain a level of cleanliness appropriate for the hospital setting. OTHER PROVISIONS HOURS OF OPERATION. The contractor shall provide services either on-site at NMCSD or via internet from home four days per week, from 0730 to 1800 including an uncompensated ?-hour meal break. The exact schedule shall be coordinated 30 days in advance between the contractor and the COR. PROBLEM EMPLOYEES. Employees with alcohol or drug abuse problems may be allowed to return to this contract only with prior Government approval. A Contractor charged or indicted for a felony shall be removed until the legal process is complete. If the legal proceeding results in a finding of not guilty on the merits of the case, the Contractor may be allowed to return to work. The COR shall be notified. In all other cases, the Contractor may be allowed to return only with prior Government approval. Confidentiality Of Information. Unless otherwise specified, all financial, statistical, personnel and/or technical data which is furnished, produced or otherwise available to the Contractor during the performance of this contract are considered confidential business information and shall not be used for purposes other than performance of work under this contract nor be released by the Contractor without prior written consent of the Commanding Officer via the COR. Any presentation of any statistical or analytical materials, or any reports based on information obtained from the studies covered by this contract, will be subject to review and approval by the Commanding Officer via the COR before publication or dissemination. Disclosure of Information. Neither the Contractor nor Contractor employees shall make any disclosure regarding the contract, NMCSD patients, employees or staff members without prior approval of the Commanding Officer. All inquiries from the media shall be forwarded to the NMCSD Public Affairs Officer. The Contractor and Contractor employees shall make no use of any Government facilities or other Government property in connection with outside employment. The Secretary of the Navy has determined that the illegal possession and use of drugs and paraphernalia by Contractor employees in the military setting contributes directly to military drug abuse and undermines command efforts to eliminate drug abuse among military personnel. The policy of the Department of the Navy (including the Marine Corps) is to deter and detect drug offenses by contract employees on military installations. Measures to be taken to identify drug offenses on military installations, and to prevent introduction of illegal drugs and paraphernalia, include routine, random inspections of vehicles on entry or exit, with drug detection dog teams, when available, and random inspection of personal possessions on entry or exit. When there is probable cause to believe that a Contractor employee on board a Naval or Marine Corps installation has been engaged in use, possession or trafficking of drugs, that employee may be restricted or detained for the period necessary until he can be removed from the installation or can be turned over to local law enforcement authorities having jurisdiction, as appropriate. When illegal drugs are discovered in the course of an inspection or search of a vehicle operated by a Contractor employee, the employee and vehicle may be detained for a reasonable period of time necessary to turn the employee and the vehicle over to appropriate civil law enforcement officials, and action may be taken to suspend, revoke, or deny clinical privileges as well as installation driving privileges. Implicit with the acceptance of this contract is the agreement by the Contractor and his employees to comply with all Federal statutes, laws and regulations, including those regulations issued by the commander of the military installation. The Contractor shall comply with all fire prevention measures prescribed in the installation fire protection regulations which are in or may be put into effect during the course of this contract. Copies of these regulations are on file in the office of the Head, Operating Management Department or with the COR. The Contractor shall be liable for loss of Government property attributed to negligent or willful misconduct of the Contractor or his employees, including failure to comply with the fire prevention measures prescribed in the aforementioned regulations. At the close of operations each day, the Contractor shall be required to make a thorough inspection in each work area to determine that all necessary safeguards relative to probable fire hazards are in effect. The Contractor shall familiarize his employees with the aforementioned fire regulations, location of fire reporting telephones near work sites, and correct fire reporting procedures. The Contractor and his employees shall be cognizant of and observe all requirements for handling and storing combustible supplies and materials, daily disposal of combustible waste, trash, etc. All accidents which may arise out of or in connection with the performance of services required herein, and which result in injury, death or property damage, shall be reported immediately to the Safety Department and the COR and within 24 hours to the NMCSD QAI/RM Department. Verbal reports shall be followed up in writing within 24 hours. Statements of witnesses shall be included. If any claim is made by a third party against the Contractor on account of any accident which occurs in connection with the performance of this contract, the Contractor shall promptly report the facts in writing to the MTF legal officer, the MTF QAI/RM Department, MTF Safety Department and the COR. The Contractor shall be responsible for payment of all wages and salaries, taxes, withholding payments, penalties, fees, fringe benefits, professional liability insurance premiums, contributions to insurance and pension or other deferred compensation plans including, but not limited to, Workers' Compensation and Social Security obligations, licensing fees, etc., and the filing of all necessary documents, forms and returns pertinent to all of the foregoing. The Contractor shall indemnify and hold the Government harmless from and against any and all claims by Contractor employees for the payment or filing of any of the foregoing compensation. The Contractor agrees to pay all applicable federal, state, and local income taxes, including any and all other Governmental fees, taxes, or expenses levied against it. Payment Contractor is registered with Dun and Bradstreet for a DUNS number and on the Commercial Contractor Registry (CCR) for the Cage Code. Contractor will register and participate in the Wide Area Work Flow (WAWF). All invoicing will be through electronic invoicing with certification of work performed by the government invoice acceptor (GPOC) then through the NMCSD Receipt Control and finally paid by electronic funds transfer (EFT) via DoD Finance and Accounting System (DFAS). Contractor shall maintain current accounts, records, and other evidence supporting all expenditures chargeable to NMCSD under this contract for at least six months after completion or termination of this contract. PERSONNEL QUALIFICATIONS CLINICAL RESEARCH ASSISTANT QUALIFICATIONS. The contractor shall meet and maintain all qualifications specified in this section. Professional Qualifications: Contractor must possess a Master?s degree or a bachelor?s degree with two to three years as a clinical research assistant. A proof of education must be submitted along with the Resume/Curriculum Vitae including three past performance references and/or letters of recommendation that may enhance ranking if they address such items as clinical skills, professionalism, or specific areas of expertise. Then total Continuing Education hours within the preceding two years. Contractor must possess excellent written and verbal communication skills as evidenced by experience and/or letters of recommendation. Contractor must have extensive experience in coordinating and scheduling personnel and work events. Contractor should have completed DoD Acquisitions 101 training course and be competent in general DoD science and technology acquisition logistics and general DoD systems life-cycle programs. Contractor must be experienced in research processes: reviewing case reports, creating and managing adverse event and side effects forms, coordinating the flow of adverse event/side effects information between case workers, IRB, medical monitor and principal investigator, handling case report forms in a secure manner and be certified under the HIPPA regulations regarding patient information. Contractor must be well experienced with MS-Word, Excel and PowerPoint Software. Contractor must have completed Clinical Research Associate Education and Training Program and be competent in FDA regulations and processes, IRB applications and review processes, Financial disclosure regulations, ICH guidelines, protocol design and development, clinical trial management and monitoring, and Adverse Event protocol. All qualification requirements will be evaluated during the credentials review and privileging process. This solicitation incorporates the following FAR and DFARS Clauses/Provisions: 52.212-1 Instruction to Offerors-Commercial Items (Jan 2004), 52.212-3 Offeror Representations and Certifications-Commercial Items (May 2004), 52.212-4 Contract Terms and Conditions-Commercial Items (Oct 2003), 52.212-5 Contract Terms and conditions Required to Implement Statutes or Executive orders-Commercial Items (Oct 2004), with the following clauses incorporated by reference in paragraphs (a) (1) 52.233-3 Protest after Award (Aug 1996)(31 U.S.C. 3553), (2) 52.233-4 Applicable Law for Breach of Contract (oct 2004)(Pub. L. 108-77, 108-78); (b) 52.219-6 Notice of Small Business Set-Aside (June 2003) (15 U.S.C. 644), 52.222-3 Convict Labor (June 2003) (E.O. 11755), 52.222-19 Child Labor-Cooperation with Authorities and Remedies (Jun 2004)(E.O. 13126, 52.222-21 Prohibition of Segregated Facilities ( Feb 1999), 52.222-26 Equal Opportunity (Apr 2002)(E.O. 11246), 52.222-35 Equal Opportunity for Special Disabled and Vietnam Era, and Other Eligible Veterans (Dec 2001) (38 U.S.C. 4212), 52.222.36 Affirmative Action for Workers with Disabilities (Jun 1998)(29 U.S.C 793), 52.222-37 Employment Reports on Special Disabled Veterans and Veterans of the Vietnam Era, and Other Eligible Veterans (Dec 2001)(38 U.S.C. 4212)), 52.225-13 Restrictions on Certain Foreign Purchases (Oct 2003)(E.o.s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of Treasury) and 52.232-33 Payment by Electronic Funds Transfer-Central Contractor Registration (Oct 2003)(31U.S.C. 3332), 252.204-7004 Alt A Required Central Contractor Registration Alternate A (Nov 2003), 252.225-7002 Qualifying Country Sources as Subcontractors (Apr 2003), 52.252-1 Solicitation Provisions Incorporated by Reference (FEB 1998); 52.252-2 Clauses Incorporated By Reference (FEB 1998), 252.212-7001 Contract Terms and Conditions Required to Implement Statutes or Executive Orders Applicable to Defense Acquisitions of Commercial Items (Sep 2004), with DFARS Clauses incorporated in reference (b) 252.225-7001 Buy American and Balance of Payment program (Jan 2004) (10 U.S.C. 10a-10d, E.O. 10582 and 252.232-7003 Electronic Submission of Payment Requests (Jan 2004) (10 U.S.C. 2227), 52.237-2 Protection of Government Buildings, Equipment, and Vegetation (Apr 1984). The clauses and provisions may be accessed in full text at these addresses: http://www.arnet.gov and http://farsite.hill.af.mil. NOTICE TO CONTRACTORS: Quotations will be evaluated based on personnel qualification, past performance, and price. Offeror must provide at least three references. Will only consider firm fixed price quotations. Offeror must provide the unit, and extended amount. Offeror must complete and submit with the quotations FAR provision 52.212-3 Offeror Representations and Certifications-Commercial Items (May 2004). Contractor must be registered to the Central Contractor Registration (CCR) prior to award. The website address for CCR registration is www.ccr.gov. A Dunn and Bradstreet number is required to register. The NAICS code is 541710. The size standard is $6.0. The offer due date is close business on 03/23/2005.
- Place of Performance
- Address: Naval Medical Center San Diego, 34800 Bob Wilson Drive, San Diego CA
- Zip Code: 92134
- Zip Code: 92134
- Record
- SN00770990-W 20050319/050317212407 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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