Auditing Svcs IDIQ - Granite Clinical Research - Base +4

Added: May 28, 2015 3:44 pm Modified: Jun 11, 2015 5:28 pmTrack Changes This solicitation amendment is issued to incorporate the following information:

" CLARIFICATION - The closing date for offers, contract performance period, price schedule, and evaluation criteria noted in the pre-solicitation notice has been superseded by the information contained in the solicitation, dated 5/28/2015:

o The closing date for offers is 6/16/2015, 10:00AM MST;

o Pricing shall be submitted for:

" Base Year (est. 7/1/2015-6/30/2016)

" Option Year 1 (est. 7/1/2016-6/30/2017)

" Option Year 2 (est. 7/1/2017-6/30/2018)

" Option Year 3 (est. 7/1/2018-6/30/2019)

" Option Year 4 (est. 7/1/2019-6/30/2020)

o Evaluation criteria shall be as noted in Section E, Exhibit A;

" QUESTIONNAIRES - The last day for receipt of all questionnaires from Offeror's references is revised from 9/11 to 9/15/2015;

" BACKGROUND INVESTIGATIONS (B/I) - The B/I process is a time-consuming and laborious one, which can take several months to accomplish. Offerors who have completed their investigations for other Federal Agencies and possess the necessary security level called for in the Statement of Work, should include this information in their technical submittals. This does not ensure that an additional B/I will not be required in support of this project, but it may facilitate the process and shorten the timeline.

" QUESTIONS & ANSWERS:

o May we receive and review the VA-specific standards that will be monitored and audited against?

" VHA Handbook 1200.05: http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=3052

" VHA Handbook 1108.04: http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2497

" VHA Handbook 1058.01: http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2463

o Will 21 CFR Parts 11, 50, 54, 56, 58, 312, 314, 812 and/or 814 regulations be a standard for any of the monitoring or auditing scope of work, as defined in Solicitation Section B.2 Statement of Work Section 7.1?

" Yes, particularly those studies within an IND/IDE.

o May we review the Quality Assurance Surveillance Plan (QASP) referred to in Solicitation Section B.2 Statement of Work Section 8?

" The QASP is an internal document which the awardee and the CSP project manager will address and work with after award. This will allow contractor and customer to come to terms on a Quality Assurance (contractor) / Quality Control (CSP) process for effective oversight and management of the project.

o Are there any limitations or requirements for the format of the Solicitation response/proposal with regard to font, margins or length of document?

" There are no specific formatting requirements, though preference is 1" margins and Times New Roman font. With regard to the length, you should be thorough in detailing your technical qualifications, but due to the extremely tight timelines for award of a follow-on contract by 7/1, we ask that you be considerate of the time it will take our TEB to review your submittal.

o Solicitation Section B.2 Statement of Work Section 7.1 Subtask 1 (focused or specialized Quality Associate visits) and Subtask 2 (routine CRQA visits) are different in nature (audit versus monitoring) and thus would require different skills and knowledge for the personnel conducting these two types of visits. Within the clinical research industry, these two types of visits/persons (auditor versus monitor) bill at significantly different rates (auditor higher than monitor). The solicitation requires a single daily rate for both types of visits on the Attachment 1 Pricing Schedule, but does not provide an estimate of the number/ratio between focused or specialized Quality Associate visits (audits) versus routine CRQA visits (monitoring). What assumptions or further information can be provided by the VA to help the offeror/contractor develop their pricing with regard to these two different types of visits? Perhaps separate pricing schedules can be submitted for the focused or specialized Quality Associate visits (audits) and the routine CRQA visits (monitoring).

" These visits are not referring to monitoring services. They are routine audits and focused audits to be performed by an auditor.



Questions concerning this solicitation amendment should be directed to Enrique.Rivera@va.gov , with the email subject "VA258-15-R-0471, Auditing Services".

Added: May 28, 2015 3:44 pm The Department of Veterans Affairs, Veterans Health Administration, VISN 18 intends to issue a Request for Proposal for the services of experienced contractors to provide Good Clinical Practice Clinical Research Quality Assurance (GCP CRQA) services for 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



The evaluation will be divided into four (4) sub-factors and supporting criteria. Sub-factor 1, Professional Certifications/Degrees, is more important than sub-factor 2.



Sub-Factor 1: Professional Certifications/Degrees & Experience -

" Bachelor Degree in a medical or scientific field with five years or more research monitoring experience, or

" Licensed Health Care Professional with five years or more research monitoring experience.

" Experience: This applies to both the Offeror and its staff, and will determine Offeror's ability to provide qualified staff and required licensing under this contract. The Offeror shall identify that it has qualified staff to provide services indicated in the solicitation, which offer the most likelihood of successful performance.

" Current copy of certification (i.e., Specialty/Sub-specialty, ACRP, SCRA, etc.)

" Copy of resume of curriculum vitae with a minimum of 3 current references

" Research Experience (preferred)



Sub-Factor 2: Safeguarding of Patient Health Information (PHI) -

" Describe Offeror's procedures used to safeguard VA patient records under this contract. The Offeror's approach should include documentation of physical security of records and steps taken to prevent disclosure of an individual record, report or other private information of the patient.



Sub-Factor 3: Technical Abilities/Capabilities

" Basic Computer knowledge

" Software knowledge in Microsoft Office Programs (e.g. Word, PowerPoint, Excel, etc.)

" Human Subjects and Good Clinical Practices (GCP) Certification (Preferred)



Sub-Factor 4: 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

Clinical Research Quality Associate (CRQA) visits and associated services required:

Task 1 - CRQA visits (with pre and post work)

a. Subtask 1 - Conduct focused or specialized Quality Associate Visits - one to four days [CLIN 1 & 2]



The CRQA shall conduct periodic focused or specialized QA visits per the SMART SOPs to inspect VA investigators for compliance with GCP and with VA and CSP Research policies:



o VHA Handbook 1200.05

o 45 CFR 46 - Protection of Human Subjects

o 38 CFR 16 (VA Common Rule) - Protection of Human Subjects

o E6 - ICH Guidelines - Good Clinical Practice

o CSP Guidelines

o Global SOP - SMART Monitoring 6.5 & SMART Auditing 7.5

o SMART SOPs

o 250 - SMART Monitor and Auditor Training - 8/02/12

o 430 - Monitoring Report Review & Distribution - 07/30/12

o 440 - Monitoring Report Follow-up and Resolution - 07/30/12

o 540 - SDR Audit Report Review & Distribution - 7/31/12

o 550 - SMART Audit Report Follow-up and Resolution - 08/02/12

o VHA Handbook - 1108.04, 1058.01

o Conduct periodic site visits per SMART SOPs to inspect VA investigators research study for compliance with GCP and with VA and CSP research policies:



" Review subject and investigator study records for compliance with GCP, VA and CSP research policy

" Know and comply with VA Privacy and Data Security Policy during site visits

" Provide to the SMART Chief immediate feedback of significant discoveries made during site visits

" Provide guidance during site visits on study conduct and use of GCP tools to improve study site practices

" Prepare reports after each inspection for the SMART, citing opportunities for improvement (OFIs) and providing recommendations for correcting problems and improving practice

" Conduct periodic site inspections per the SMART SOPs to inspect offices of CSP Management (the Sponsor) for compliance with GCP and with VA and CSP research policies

" Assess effectiveness of interactions between the investigator site study team and the CRQA and other representatives of CSP



b. Subtask 2 - Prepare site visit reports and summary letters [CLIN 1]



Within two weeks (ten work days) of site visit, the CRQA shall:



" Complete a site visit report (using a pre-approved template) and prepare a follow-up QA summary letter, if applicable;

" Provide QA documents, which may include reports and follow-up summary letter, if applicable, to the SMART;

" Inform the SMART Lead CRQA of recurrent and/or serious compliance deficiencies;

" Assist with implementation of Corrective Actions and/or Preventive Actions (CAPAs) in order to mitigate recurrence of compliance deficiency;



c. Subtask 3 - Additional notes about preparing and conducting site visits [CLIN 1 & 3]

" The CRQA's reporting requirements will necessitate computer program access and literacy in Microsoft Office Programs, e.g., Word, Excel, PowerPoint, as well as Internet capability in order to transmit documents and access email and correspondence.

" Frequency of Visits - The frequency and timing of CRQA visits will be determined by SMART for each site based on the following:

o Study Team recommendations

o Subject accrual rate at the site

o Total number of subjects to be enrolled at the site

o Complexity of the study protocol

o Data collection and record keeping proficiency at the site

o Observations and corrective actions from previous monitoring visits

o

Task 2 - CRQA Visits (without pre and post work)

" The CRQA may support another CRQA in conducting site monitoring visits at the request of the Lead CRQA

Subtask 1 - Create site visit tools

Subtask 2 - Develop GCP tools for use by participating sites

Subtask 3 - Design data from casebooks for organizing patient files at investigative sites

Subtask 4 - Develop requirements, procedures and guidance for source documentation of key study data within each trial

Subtask 5 - Remote Records Review

Subtask 6 - Study Orientation

Subtask 7 - Other QA activities as assigned (i.e., Serve as the Sponsor's Designated Representative for the review of reports received from the site monitors

III. Based on the importance of past performance in assessing an Offeror's qualifications for conducting these GCP CRQA services, "Offeror" and "Reference" past performance questionnaires are included to provide interested firms additional time for contacting potential references. Please follow the instructions on Exhibits B & C to ensure compliance with the past performance criteria.



Solicitation number VA258-15-R-0451, will be posted on or about 13 May 2015. The date for receipt of offers shall be 3 June 2015. Questions concerning this pre-solicitation should be directed to Enrique.Rivera@va.gov , with the email subject "VA258-15-R-0451, Auditing GCP CRQA Services". All questions must be sent formally by email no later than close of business on 11 May 2014.



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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.