36C26224Q0007.docx

Sources Sought Notice Sources Sought Notice

GENERAL INFORMATION

SET-ASIDE

Network Contracting Office 22 4811 Airport Plaza Drive Suite 600 Long Beach CA 90815

POINT OF CONTACT*

Contract Specialist David Odne david.odne@va.gov

PLACE OF PERFORMANCE

VA New Mexico Healthcare System

1501 San Pedro Drive, SE

Albuquerque NM

COUNTRY

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

Sources Sought Announcement: This is a “SOURCES SOUGHT ANNOUNCEMENT ONLY”, it is neither a solicitation announcement nor a request for proposals or quotes and does not obligate the Government to award a contract. Requests for a solicitation will not receive a response. Responses to this sources-sought must be in writing. The purpose of this sources sought announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential sources capable of providing the services described below. Documentation of technical expertise must be presented in sufficient detail for the Government to determine that your company possesses the necessary functional area expertise and experience to compete for this acquisition. Responses to this notice shall include the following: (a) company name (b) address (c) point of contact (d) phone, fax, and email (e) Unique Entity ID (f) Cage Code (g) Tax ID Number (h) Type of business, e.g. small or other, as appropriate and (i) must provide a Capability Statement that addresses the organization’s qualifications and ability to perform as a contractor for the work described below in italics.

The New Mexico VA Healthcare System (NMVAHCS) located at 1501 San Pedro Drive, SE Albuquerque, NM 87108 is seeking a contractor to provide all the labor, parts, material, supervision, and equipment necessary to provide auditing to current Good Practice (GXP) standards. Vendor will perform annual Good Practice (GXP) audits of the Cooperative Studies Program’s Clinical Research Pharmacy Coordinating Center (CSPCRPCC). Audit Reports will be both Objective and Subjective and the Subjective observations will include opportunities for improvement.

The contractor shall provide audit support for one audit per contract year and perform additional GXP process audits during the contract period. Each year the vendor shall perform an audit with a focus as detailed below. The audit plan will be based on current ICH guidelines and FDA guidance.

The vendor will coordinate the audit agenda with CSPCRPCC focal point at least four weeks prior to the visit. The Scope of the audits will focus on the annual topics and include the following: Reviewing the specific Procedures covering the processes. Documentation Practices Training records.

Base Year: cGMP processes, Manufacturing, Packaging, Quality Control (QC), Quality Assurance (Bioanalytics), Corrective and Preventive Actions (CAPA), Environmental Management.

Year1: Good Distribution Process (GDP), Shipping, Receiving, Calibration, Biorepository, Vendor qualification.

Year 2: Computer System Validation (CSV), Electronic Records, Electronic signatures, GXP-related Systems, Change Control, Quality Management System (QMS), Management Review.

Year 3: Good Clinical Practice, Monitoring, Auditing, Study Design and Management.

Year 4: Good Pharmacovigilance Practices, Regulatory Correspondence, Study participant safety, Reporting Serious Adverse Events (SAE) and Unexpected Adverse Events (UADE).

GXP Audit Reports: The audit objective and subjective findings should address Data Integrity, Documentation Practices, Compliance to regulations, Adherence to procedures, Quality Assurance and Control, Data, Data Analysis and Reports, Computerized Systems: w/ Validation, 21 CFR Compliance, Software Development, Change Control Security, Back Ups and Recovery Plan, Human Subject Protection, Training, Onboarding, Qualifications of the Staff, Opportunities for Improvement, Culture, Standardization.

GXP Audit Reports shall be completed within thirty (30) working days after audit Important Information: The Government is not obligated to - nor will it pay for or reimburse any costs associated with responding to this sources-sought synopsis request. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. The VA is mandated by Public Law 109-461 to consider a total set-aside for Service-Disabled Veteran Owned Small Business set aside. However, if response by Service-Disabled Veteran Owned Small Business firms proves inadequate, an alternate set-aside or full and open competition may be determined. No sub-contracting opportunity is anticipated. The North American Classification System (NAICS) code for this acquisition is 541611 ($24.5 Million).

Notice to Potential Offerors: All offerors who provide goods or services to the United States Federal Government must be registered in the System for Award Management (SAM. Additionally, all Service-Disabled Veteran Owned Businesses or Veteran Owned Businesses who respond to a solicitation on this project must be registered with the Department of Veterans Affairs Center for Veterans Enterprise VetBiz Registry located at VetBiz Portal . All interested Offerors should submit information by e-mail to david.odne@va.gov. All information submissions to be marked Attn: David Odne; Contract Specialist and should be received no later than 11:00 AM Pacific Time on the due date found on page 1 of this sources sought notice.

Sources Sought Notice