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Viable Air & Surface Sampling - Attachment

General Information

Document Type:FILE
Posted Date:Dec 04, 2017
Category: Quality Control, Testing and Inspection Services
Set Aside:N/A

Contracting Office Address

Department of Veterans Affairs;Gulf Coast Veterans Health Care System;Network Contracting Office 16;400 Veterans Avenue;Biloxi MS 39531


This is a SOURCE SOUGHT NOTICE only for Market Research. Response to this notice will be used for information and planning purposes. No proposals or quotes are being requested or accepted with this notice. THIS IS NOT A SOLICITATION FOR PROPOSALS or QUOTES and NO CONTRACT SHALL BE AWARDED FROM THIS NOTICE. This notice shall NOT be construed as solicitation or as an obligation on the part of the Department of Veterans Affairs (VA). Responses to this sources sought is not a request to be added to a prospective bidders list or to receive a copy of the solicitation. VISN 16, is seeking preferably SDVOSB/small businesses (but will accept other than small business for market research) capable of providing environmental air and surface testing /certification for the Overton Brooks VA Medical Center located in Shreveport, LA. Brief Description of Services: The Network Contracting Office (NCO) 16 is currently seeking a company that can provide the viable air and surface sampling for the CACI and CAI gloveboxes located at the Overton Brooks VA Medical Center as per the draft statement of work below. DRAFT STATEMENT OF WORK PURPOSE This requirement is for procuring Environmental Testing of Pharmacy Compounding Aseptic Containment Isolator (CACI) and Compounding Aseptic Isolators (CAI) Gloveboxes for the Overton Brooks VA Medical Center, located at 510 East Stoner Avenue, Shreveport, LA 71101. SCOPE Contractor shall furnish service as specified within to ensure proper operation of the CACI and CAI gloveboxes as per USP 797/800 and manufacturer s requirements. Contractor shall provide Controlled Environment Testing Association(CETA) certified technician to perform all testing, inspection and certification of air and surface. ENVIRONMENTAL SAMPLING Air Sampling - Impaction volumetric air sampling under dynamic conditions with a sample size of 1000 liters in all locations. Sampling to take place at the end of day. Two samples in the ante chamber and four samples in the direct compounding area. Three samples for bacterial contaminates and three samples for fungal contaminates. Surface Sampling Contact plates with general growth medium which neutralizes cleaning agents and prevents false negative. Sampling to take place at the end of the largest batch of the day. Two samples in the ante chamber and four samples in the direct compounding area. Three samples for bacterial contaminates and three samples for fungal contaminates. Contractor shall furnish all labor, equipment, tools, materials and travel necessary to test, inspect and certify Government Owned CACI and CAI Equipment and pharmacy clean rooms. Inspections are required to be performed semiannually. If a positive result received, then testing will be performed monthly until 3 consecutive negatives are obtained. All equipment used in the sampling process will require the following be provided to pharmacy: Manufacturer Model Serial Number Equipment Calibration Date Calibration Due Date Contractor shall provide written certification reports upon completion of semiannual or monthly testing, inspection and certification. Written report will be provided within 15 days of completion of job. Written report must contain: Test results, media lots utilized for samples, comments indicating when dynamic conditions were used, Certificates of Analysis of media used, and room number sketches depicting testing locations, and all calculations. Testing and Certification Parameters Test Description/Comments Quantity Viable Air Sampling Impaction Volumetric Air Sampling under dynamic conditions with a sample size of 1000 liters in all locations 12 Months Viable Surface Sampling ------- 12 Months Provide a list of recommendations and discrepancies. Environmental sampling will be performed monthly until three (3) consecutive cultures with no- actionable recommendations per USP 797 Guidelines. Contractor shall notify the Program Manager or Contracting Office Representative (COR) in writing (letter) or email, in the event any / all regulatory guidance governing certification of any subject equipment change. Written advisement will include any issues which will impact testing/certification. Contractor will also advise Shreveport s Program Manager /COR of recommendations to resolve any issues related to the regulatory changes. PERIOD OF PERFORMANCE The period of performance shall be for an 8-month base and four (4) twelve (12) month option periods commencing February 1, 2018 through September 30, 2018 (base). Option Period One: October 1, 2018 through September 30, 2019 Option Period Two: October 1, 2019 through September 30, 2020 Option Period Three: October 1, 2020 through September 30, 2021 Option Period Four: October 1, 2021 through September 30, 2022 The contractor (or Representative) shall contact the Program Manager or COR, to schedule work and prior to the beginning of work. Services are to be performed during our business hours between 7:30 am and 4:00pm Central Standard Time, excluding Holidays. Due to the workload of the pharmacy during business hours, the contractor may need to work after 4:00pm CST to accommodate the compounding schedule at the pharmacy. Contractors that are willing to perform after-hours work should include this information in their bid documentation. If a contractor is willing to perform services after 4:00pm CST this service must be included within the bid pricing as no extra charge will be allowed. The ability to perform work after hours is not required; however, preferences will be given to contractors that offer flexible work hours. DELIVERABLES Again, after work is completed, the Contractor is to submit in writing, a complete report of services performed for each item of equipment and must include the information listed above within 15 days of completion. The report should have guidance on interpreting results, possible contamination pathways and proper corrective actions to remediate contamination. The contractor shall supply every unit that passes certification specifications with a certification sticker. INVOICING a. Payment will be made monthly in arrears, invoices will be prepared by the Contractor, and submitted through Tungsten Network (formerly known as OB10) http://www.tungsten-network.com/us/en/. A properly prepared invoice shall contain: Invoice Number and Date Contractor s Name and Address Accurate Purchase Order Number Supply or Service provided Period Supply or Service Provided Total Amount Due b. Please begin submitting your electronic invoices through the Tungsten Network for payment processing, free of charge. c. If you have questions about the e-invoicing program or Tungsten Network, contact information is as follows:               Tungsten e-Invoice Setup Information: 1-877-489-6135 Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com FSC e-Invoice Contact Information: 1-877-353-9791 FSC e-invoice email: vafsccshd@va.gov Web Address: HTTP://WWW.FSC.VA.GOV/EINVOICE.ASP Offeror s response to this Notice shall be limited to 5 pages and shall include the following information: Offeror s company name, DUNS, Federal Tax ID, address, point of contact, title, phone number, and email address Offeror s capability to meet this requirement including any current contracts (Civilian or Government). Response must show clear and convincing evidence that your company has the capabilities and qualifications to provide this service to be considered as a source. SDVOSB and VOSB shall also show evidence that they will perform 51% of the work (additional 5 pages allowed). All parties are asked to identify any subcontractors that shall also be utilized. Offeror s type of business (small or large) and socioeconomic status whether Service Disable Veteran Owned, Veteran Owned, HUBZone, 8(a), Woman Owned, Small Disadvantaged, etc. If applicable, Service-Disabled Veteran-Owned Small Business (SDVOSB) or Veteran-Owned (VOSB) must be verified with the seal in VetBiz to be considered as a source. Same for/with subcontractor. The NAICS code 541990, all Other Professional, Scientific and Technical Services and the Size Standard is $15.0 million. The PSC code H999, testing and Inspection Services, applies. Responses must be received by no later than 12:00pm Central Standard Time, Wednesday December 6, 2017. Responses shall be emailed to tina.harris3@va.gov using Sources Sought 36C25618Q9041 Air & Surface Sampling in the subject line. Facsimile or Telephonic responses will not be accepted. All interested parties are reminded to be registered with the System for Award Management (SAM) at http://www.sam.gov in order to be eligible for award of Government contracts. In addition, if you are and SDVOSB, you must be registered and certified in VetBiz. Should a solicitation be issued, the above NAICS will be utilized. ****AGAIN, THIS IS NOT A REQUEST FOR QUOTES BUT FOR INFORMATION FOR MARKET RESEARCH; CAPABILITY STATEMENTS ARE ALLOWED. ****

Original Point of Contact

POC Tina Harris

Place of Performance

Department of Veterans Affairs;Overton Brooks VA Medical Center;510 East Stoner Avenue;Shreeport, LA
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Link: FBO.gov Permalink
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