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FBO DAILY - FEDBIZOPPS ISSUE OF MAY 07, 2015 FBO #4912
DOCUMENT

A -- Auditing GCP CRQA Project Management Services Cooperative Studies Program Department of Veterans Affairs - Attachment

Notice Date

5/5/2015
 

Notice Type

Attachment
 

NAICS

541611 — Administrative Management and General Management Consulting Services
 

Contracting Office

Department of Veterans Affairs;SAOW/NCO 18;4135 S. POWER RD. STE 103;MESA, AZ 85212
 

ZIP Code

85212
 

Solicitation Number

VA25815R0480
 

Response Due

6/4/2015
 

Archive Date

8/3/2015
 

Point of Contact

Enrique Rivera
 

E-Mail Address

e.rivera@va.gov<br
 

Small Business Set-Aside

N/A
 

Description

The Department of Veterans Affairs, Veterans Health Administration, VISN 18 intends to issue a Request for Proposal for the services of an experienced contractor to serve as a key provider of GCP services and guidance for program development and maintenance, during clinical trials being conducted by the VA's Cooperative Studies Program. The period of performance shall be a Base period (award through 9/30/2015) and four (4) one-year Options. This is a pre-solicitation notice for commercial services prepared in accordance with the format specified in the Federal Acquisition Regulation Subpart 5.203(a), as supplemented with additional information included with this notice. The acquisition will be a set-aside 100% for small business in accordance with FAR 19. The North American Industry Classification Code (NAICS) is 541611, Administrative Management and General Management Consulting Services, with a small business size standard of $15,000,000.00. Evaluation and award will be made in accordance with FAR 15.101-1, Tradeoff Process. I.A summary of the evaluation criteria used for source selection is listed below to assist you in determining your qualifications for this solicitation: A.Factor # 1 - TECHNICAL PROPOSAL Sub-Factor 1: Professional Certifications/Degrees & Experience - "Minimum of a Bachelor's Degree in Science or Nursing or a graduate degree in a related field; or be a registered nurse, pharmacist, physician or other licensure as a health-care provider "Certified as a Clinical Research Associate (CRA) by the Association of Clinical Research Professionals (ACRP) or by an equivalent certifying body "Possess at least five years of experience in Good Clinical Practice (GCP) Quality Assurance (QA) services with evidence of substantial experience in: "Demonstrating Expertise and Conducting For Cause Audits "Preparing Good Clinical Practices (GCP) training materials for research professionals "Presenting formal classes to groups with varied backgrounds "Performing medical record and clinical chart review "Demonstrated expertise in coordinating and directing the actions of teams of monitors, auditors and other clinical QA personnel "Possess at least three years' experience in GCP Quality Assurance (QA) service in research governed by the common rule, ICH, FDA CFR's that includes actual experience monitoring or auditing of federally funded research. "Perform scheduled site audits/visits, as well as requested investigations "Work accurately with various Government computer systems to retrieve medical records for analysis "Demonstrate ability to quickly develop a good working relationship with researchers Sub-Factor 2: Technical Abilities/Capabilities oComputer knowledge oHardware/software knowledgeable in Microsoft Word, Excel and PowerPoint oExperience utilizing a PowerPoint integrated audience response system to provide training oCapable of responding quickly to emergent situations with ready availability to meet and confer with Site Monitoring, Auditing and Resource Team (SMART) management located in Albuquerque, New Mexico in the offices of the Veterans Affairs (VA) Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (CSPCRPCC) oGCP trained (completed courses provided by nationally recognized training providers, e.g., Barnett International, Association of Clinical Research Professionals (ACRP) Sub-Factor 3: Veteran Preference In an effort to achieve socioeconomic small business goals, depending on the evaluation factors included in the solicitation, VA may evaluate Offerors based on their veteran-owned or service-disabled veteran-owned status, their proposed use of veteran-owned or service-disabled veteran-owned small businesses as subcontractors, and their past performance on adherence to subcontracting plan requirements. B.Factor # 2 - PAST PERFORMANCE: The Government will conduct a performance risk assessment based upon the Past Performance of the Offeror as it relates to the probability of successful accomplishment of the work required by the solicitation. The Past Performance proposal evaluation will consider such things as an Offeror's business practices, customer relationship, and ability to successfully perform as proposed. For the purpose of this solicitation, currency is performance occurring within the last five (5) years through the solicitation release date. Past Performance includes current on-going (present) performance. Relevance will also be evaluated in the overall Past Performance rating (i.e. very relevant, semi-relevant, and not relevant). Ratings will consider the Offeror's Past Performance considering currency, relevancy, sources, context, and trends. C.Factor #3 - PRICE "The Government evaluation team will conduct a Price evaluation of each Offeror's Pricing Schedule to determine whether or not each proposal complies with the stated criteria: "Reasonableness". If the proposed price is determined to be reasonable, a REASONABLE rating will be given; if found to be unreasonable, an UNREASONABLE rating will be assigned to the price evaluation factor. "Prices will also be analyzed to determine whether they are realistic for the work to be performed, reflect a clear understanding of requirements, and are consistent with the corresponding Technical Proposal. Proposals must include the cost of the entire service including overhead and profit. II.A condensed version of the SOW has been enclosed for your review. STATEMENT OF WORK (SOW) As of 4/30/2015 SPECIFIC TASKS 1.1TASK 1 - The Contractor will manage, direct and oversee the GCP Clinical Quality Assurance Program for CSP Trials 1.1.1Subtask 1 - Oversee or serve as the Sponsor's Designated Representative for the review of reports received from site inspectors. 1.1.2Subtask 2 - Serve as the trainer and mentor to the site inspectors assigned to the trial. 1.1.3Subtask 3 - Provide guidance and direction to the site inspectors before, during and after the site visits. 1.1.4Subtask 4 - Compile and analyze inspection findings, assessing strengths and deficiencies in research practices of investigators and of the VA Research facilities. 1.1.5Subtask 5 - Provide feedback to the CSP on trends and findings noted in the site inspector's reports, both individual trials and across all CSP trials, noting the appropriate application of CSP and VA policies and procedures and the need for new or revised program policies. 1.1.6Subtask 6 - Prepare, conduct and/or oversee the CSP pre-FDA Inspection Program 1.2TASK 2 - The Contractor will provide support for Program and Policy Development within the CSP 1.2.1Subtask 1 - Review the SMART, CSP and VHA policy and procedures on research and advise SMART and CSP on necessary changes; revise and develop 'GCP-consistent' Standard Operating Procedures (SOPs) for SMART and the CSP, as necessary. The SOPs shall reflect an integrated program for site monitoring, site auditing and centralized monitoring of study conduct by the Investigator and Sponsor. 1.2.2Subtask 2 - Develop and maintain a Basic Monitoring Plan template to be adapted to and implemented in all ongoing CSP trials (procedures, forms, report formats, etc.) 1.2.3Subtask 3 - Develop and maintain a prototype Site Auditing Plan to be adapted to and implemented in ongoing and future CSP trials (procedures, forms, report formats, etc.). 1.2.4Subtask 4 - Oversee revision and expansion of the SMART GCP classroom-style course, as necessary, to provide specialized versions applicable to specific audiences, e.g., Investigators, CSP personnel and non-CSP research personnel VA-wide. 1.2.5Subtask 5 - Develop packets of guidance and tools to aid Investigator and Sponsor sites in preparing for FDA inspections or other inspections for GCP compliance. 1.3TASK 3 - The Contractor shall direct and oversee Clinical Quality Assurance Site Inspections (Site and Sponsor) Subtask 1 - Ensure that site visits conducted by SMART to inspect VA investigators for compliance with GCP, VA and CSP research policies and SMART SOPS. 1.4TASK 4 - Trending of Site Visit Findings for CSP/Quality Improvement 1.5TASK 5 - Direct and Oversee GCP Training Program for VA Researchers and CSP Site Monitors 1.6TASK 6 - Oversee the development of tools, worksheet and GCP guidance for each new CSP Trial III."Offeror" and "Reference" Past Performance Questionnaires. These forms (Exhibits B & C) are enclosed to provide interested firms additional time for contacting potential references. Please follow the instructions to ensure compliance with the past performance criteria. Solicitation number VA258-15-R-0480, will be posted on or about 13 May 2015. The date for receipt of offers shall be 4 June 2015. Questions concerning this pre-solicitation should be directed to Enrique.Rivera@va.gov, with the email subject "VA258-15-R-0480, Auditing GCP CRQA Project Management Services". All questions must be sent formally by email no later than close of business on 11 May 2014. ? EXHIBIT B - OFFEROR'S PERFORMANCE RELEVANCY QUESTIONNAIRE Provide the following information requested in this format for each of the projects/contracts being described. Projects may be ongoing and cannot have been completed any later than 5 years prior to the solicitation issue date. Provide frank, concise comments regarding YOUR PERFORMANCE on the contracts you identify. Use as much space as required. A.Offeror (Your) Name (Company/Division): B.Project/Contract Title: C.Contract Specifics: 1.Description of Effort as Prime ___ Subcontractor ___ 2.Contract Number: 3.Award Date: 4.Contract $ Value: 5.Current Schedule: 6.Estimate/Final Completion Date: D.Provide detailed description of the work performed under the contract, and describe why you believe the work is very relevant, relevant or semi-relevant to this solicited project. At a minimum, address the following: (Use as much space as necessary) 1.Describe the specific elements of the work performed by your firm. 2.Indicate what elements of work, if any, were performed by your major subcontractors and indicate if those same subcontractors will be used on this IDIQ. 3.Address any technical areas about this project/contract you consider uniquely relevant to this solicitation. E.Point of Contact for Owner/Government agency Contracting Officer and or inspector; include a current phone number and facsimile number. Email address is also desired. 1.Name:Title: 2.Company/Agency: 3:Phone/Fax #" 4.Email address: End of Questionnaire Requirements - Prepare and send Exhibit C Package (Past Performance Questionnaire) to the reference(s) for each of the projects discussed.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/PhVAMC/HMC/VA25815R0480/listing.html)
 

Document(s)

Attachment
 

File Name: VA258-15-R-0480 VA258-15-R-0480_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2028349&FileName=VA258-15-R-0480-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2028349&FileName=VA258-15-R-0480-000.docx

 

File Name: VA258-15-R-0480 S02 Exhibit C Past Performance Questionnaire.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2028350&FileName=VA258-15-R-0480-001.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2028350&FileName=VA258-15-R-0480-001.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Place of Performance

Address: Department of Veterans Affairs;Cooperative Studies Program;2401 Centre Avenue SE;Albuquerque, NM 87106

Zip Code: 87106
 

Record

SN03719722-W 20150507/150505234606-b3ec84f69e48640c05f6ef14e7671433 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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