FBODaily.com | FedBizOpps: FILE | 65 | STABILITY CHAMBER - Attachment

FBO DAILY - FEDBIZOPPS ISSUE OF MARCH 24, 2017 FBO #5600
DOCUMENT

65 -- STABILITY CHAMBER - Attachment

Notice Date: 3/22/2017
Notice Type: Attachment
NAICS: 339113 — Surgical Appliance and Supplies Manufacturing
Contracting Office: Department of Veterans Affairs;VISN/18PHX;777 E. Missouri, Suite 300;Phoenix AZ 85014
ZIP Code: 85014
Solicitation Number: VA25817N0292
Response Due: 3/27/2017
Archive Date: 5/26/2017
Point of Contact: Danja Jevon Holly
E-Mail Address: holly@va.gov<br
Small Business Set-Aside: N/A
Description: THIS IS A SOURCES SOUGHT NOTICE. (A Sources Sought is defined as not an actual bid or proposal solicitation; instead, it's a solicitation of interest. Think of a Sources Sought as market research being conducted by a government agency to determine what the capabilities and interests of the marketplace are).This is not a request for actual bid or proposal solicitation. A solicitation will not be issued at this time. The Department of Veterans Affairs, Albuquerque New Mexico VA Health Care System (MNVAHCS) has a requirement for a stability chamber to be installed inside an existing room. The intent of the procurement is to award a firm-fixed price contract. To maintain the standard of the Department of Veterans Affairs, Cooperative Studies Program, Clinical Research Pharmacy Coordinating Center (CRPCC) at the Albuquerque New Mexico VA Health Care System (MNVAHCS) are requesting the purchase of a stability chamber to be installed inside an existing room; The Department of Veterans Affairs, Cooperative Studies Program, Clinical Research Pharmacy Coordinating Center (CRPCC) is involved in the conduct of clinical studies involving many different pharmaceutical products. One of the core tasks of the CRPCC is to test pharmaceutical products to ensure participant safety. A key factor in proper testing procedures is ensuring test samples are properly stored and handled. In order to store samples, they need to be kept in a stable environment controlled temperature and humidity. The CRPCC's facility currently has limited environmentally controlled storage space and needs to increase the space due to increasing storage requirements. Albuquerque New Mexico VA Health Care System (MNVAHCS): VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center 2401 Centre Avenue, SE Albuquerque, NM 87106 The applicable NAICS code is 339113 Surgical Appliance and Supplies Manufacturing. Small Business manufacturers for this NAICS code have a size standard of 750 employees. The resulting contract will be a firm fixed price order. The term of the contract is intended to be 30 calendar days ARO, with no options included. It is anticipated that a Request for Quotes will be issued in March 27, 2017. Award of a firm fixed price contract is contemplated by April 15, 2017. This notice is to conduct market research to determine if there is a sufficient number of certified Service Disabled Veteran Owned Small Businesses (SDVOSB), Veteran Owned Small Businesses (VOSB), Small Businesses (SB), or Large Business capable of performing the requirements to warrant a socio-economic set-aside or full & open competition. It is strongly recommended that interested parties register in the US Department of Veterans Affairs Vet Biz database and the Small Business Administration (SBA) database. Registration may be accomplished at http://www.vip.vetbiz.gov/ and www.sba.gov/, respectively. Interested parties responding to this sources sought request shall submit the following information at a minimum: (1) company name and address, point of contact with phone number, and DUNS number; (2) documentation relating to capability of performance of residential renovation projects (including references); (3) intentions of subcontracting program to include set-asides; (4) proof of registration in the VA Vet Biz or SBA websites or intention of registration prior to submission of offers to a solicitation; (5) documentation on company s bonding capacity and limitations; and (6) any other pertinent company documentation. The response date to this Sources Sought notice is March 27th, 2017 at 10:00 pm EST. This market research is for informational and planning purposes only to determine if a socio-economic set-aside, or full & open competition, or sole-source procurement is appropriate. The Government will not pay any costs for responses submitted. Electronic submissions are acceptable via Danja.holly@va.gov. Hard copy submissions are acceptable to VISN 18 Network Contracting Office; 777 E Missouri Ave, Suite #300, Phoenix AZ 85014. NO ADDITIONAL INFORMATION IS AVAILABLE OTHER THAN WHAT IS NOTED HEREIN. ALL FIRMS ARE INSTRUCTED NOT TO CALL THE INDIVIDUAL VA MEDICAL CENTERS REQUESTING MORE INFORMATION. Statement of Work (SOW) QC Stability Chamber 1 SCHEDULE OF SERVICES AND/OR SUPPLIES CLIN Description Qty Unit Unit Price Estimated Amount 0001 Stability Chamber 1 EA 0002 Shelving 1 SE 0003 Chamber Installation 1 JB 0004 Shelving Installation 1 JB 0005 Installation/Operation/Performance Qualification 1 EA INCL INCL TOTAL ESTIMATED COST 2 CONTRACT TITLE Stability Chamber for Assay Room 3 BACKGROUND The Department of Veterans Affairs, Cooperative Studies Program, Clinical Research Pharmacy Coordinating Center (CRPCC) is involved in the conduct of clinical studies involving many different pharmaceutical products. One of the core tasks of the CRPCC is to test pharmaceutical products to ensure participant safety. A key factor in proper testing procedures is ensuring test samples are properly stored and handled. In order to store samples, they need to be kept in a stable environment controlled temperature and humidity. The CRPCC's facility currently has limited environmentally controlled storage space and needs to increase the space due to increasing storage requirements. 4 SCOPE The vendor will provide a stability chamber to be installed inside an existing room. The vendor will also provide mobile shelving for use inside the chamber. Prior to installation, the vendor will provide the user electrical, water, and any other information related to actions that need to be completed prior to installation of the chamber. The chamber must be capable of maintaining a temperature 25 +/-2 degrees Celsius and 60% Relative Humidity +/- 5%RH. Additionally, the vendor will provide mobile shelving (on casters) for use in the chamber. 5 SPECIFIC TASKS The following section specifies the tasks for this requirement. 6.1 Provide stability chamber for storage of pharmaceutical samples. 6.1.1 Physical requirements a) Available space for chamber is 17' Wide x 9' Deep x 8' 11" High. Entrance to chamber must be along the 17' width. b) Chamber must contain necessary environmental systems to meet temperature/humidity requirements. c) Chamber must include lighting system allowing user to read labels on items stored in chamber. 6.1.2 Performance Standards a) Standard: User adjustable temperature range but able to maintain 25 degrees Celsius +/- 2 degrees Celsius b) Standard: User adjustable relative humidity range but system must be able to maintain 60% Relative Humidity (RH) +/-5%. 6.2 Provide mobile shelving for storage of pharmaceutical samples. Performance Standards a) Standard: Shelving must have wheels/casters allowing user to reposition. b) Standard: Shelving height must be less than chamber door height and ROOM DOOR height to allow shelf unit to be rolled out of the chamber. c) Standard: Shelving should maximize use of interior space but be placed where an individual can walk into the chamber and access all shelves without having to move other shelves. 6.3 Deliver stability chamber for storage of pharmaceutical samples. 6.4 Provide user documentation detailing electrical, water, and any other utilities required prior to installation. Installation of these will be performed by user. 6.5 The Contractor shall perform installation for stability chamber. Scheduling will be coordinated with COR and timing will be dependent on utility installation. 6.6 The Contractor shall install shelving for maximizing usage of space. 6.7 The Contractor shall perform qualifications and provide documentation for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Qualification must include mapping of unit to assure temperature/humidity are evenly distributed inside the chamber and that the performance standards are met at all points in the chamber. Performance Standards a) Standard: Allowable ranges for testing are from initial requirements of: - Temperature 25 degree Celsius - Relative Humidity 60% RH b) Standard: OQ mapping test: - Temperature +/- 2 degree Celsius - Relative Humidity +/- 5% RH c) Standard: PQ mapping test: - Temperature +/- 2 degree Celsius - Relative Humidity +/- 5% RH 7 PERFORMANCE MONITORING Task Standard Acceptable Quality Level Surveillance Method 7.1 Stability Chamber Delivered in acceptable condition Delivered Direct Observation 7.4 User Documentation Delivered Delivered Direct Observation 7.5 Installation Installed After delivery and being notified utilities are completed by user Direct Observation 7.7 Qualifications (IQ, OQ, PQ) Completed and documentation provided Results support/demonstrate ability to meet requirements Direct Observation 8 SECURITY REQUIREMENTS This procurement is primarily for goods (equipment and software), but there is an installation component as well. Vendor personnel will be required to come to the CSPCRPCC facility to install the equipment and software. Vendor personnel will have no access to VA IT systems, PHI, or any equipment connected to the VA network. Additionally, vendor personnel will be escorted and monitored at all times by a CSPCRPCC staff member as mandated and strictly enforced according to CSPCRPCC security policy. The C&A requirements do not apply and a Security Accreditation Package is not required. 9 GOVERNMENT-FURNISHED EQUIPMENT (GFE)/GOVERNMENT-FURNISHED INFORMATION (GFI) Available space for chamber is 17' Wide x 9' Deep x 8' 11" High. 10 OTHER PERTINENT INFORMATION OR SPECIAL CONSIDERATIONS a. Identification of Possible Follow-on Work. N/A b. Identification of Potential Conflicts of Interest (COI). N/A c. Identification of Non-Disclosure Requirements. N/A d. Packaging, Packing and Shipping Instructions. N/A e. Inspection and Acceptance Criteria. N/A 11 RISK CONTROL N/A 12 PLACE OF PERFORMANCE VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center 2401 Centre Avenue, SE Albuquerque, NM 87106 13 PERIOD OF PERFORMANCE 10/1/2017 5/1/2018 14 DELIVERY SCHEDULE 10/1/2017 5/1/2018 allows for manufacturing/shipping time followed by installation/validation time 15 ACRONYMS a. CO-Contracting Officer. The Federal employee who is warranted by the Government to enter into contracts on behalf of the Government and is the only person authorized to make changes to those contracts. b. COR-Contracting Officer's Representative. Individual designated by the CO to place orders, furnish technical guidance, advice, certify invoices, and provide general supervision of the work performed under the executed contract. c. CSPCRPCC-Cooperative Studies Program Clinical Research Pharmacy Coordinating Center. d. VAMC-Department of Veterans Affairs Medical Center. e. NMVAHCS-New Mexico Veterans Affairs Healthcare System.
Web Link: FBO.gov Permalink
(https://www.fbo.gov/spg/VA/PhVAMC/HMC/VA25817N0292/listing.html)
Document(s): Attachment; File Name: VA258-17-N-0292 VA258-17-N-0292.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3357918&FileName=VA258-17-N-0292-000.docx); Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3357918&FileName=VA258-17-N-0292-000.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: VA Cooperative Studies Program;Clinical Research Pharmacy Coordinating Center;2401 Centre Avenue, SE;Albuquerque, NM; Zip Code: 87106
Record: SN04443755-W 20170324/170322234645-1778be976399e59ddd504718480e368c (fbodaily.com)
Source: FedBizOpps Link to This Notice
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65 -- STABILITY CHAMBER - Attachment