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65--CHEMOSHIELD BARRIER ISOLATOR (NEGATIVE PRESSURE) CS600 and related equipment

Solicitation Number: VA-248-09-RQ-0387
Agency: Department of Veterans Affairs
Office: VA Caribbean Health Care System
Location: Department of Veterans Affairs Caribbean Health Care System
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VA-248-09-RQ-0387
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Solicitation
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Added: May 06, 2009 2:49 pm
NUCLEAR MEDICINE (ChemoShield CS600)1. Introduction: The VA Caribbean Healthcare System (VACHS) intends to buy and install a ChemoShield Barrier isolator (negative pressure) on the Nuclear medicine Dept. located on Calle Casia # 10 San Juan PR 00921.This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. Solicitation number VA248-09-RQ-0387. The Request for Quotation (RFQ) will follow the Veterans Administration socio economic goals Service Disabled Veteran Owned small Business and Veteran Owned Small Business etc. lowest price technically acceptable will be used. Veteran Administration Caribbean System (VACHS) requests a proposal for the buying, installation, testing, and acceptance of the ChemoShield and related equipment see material list as described in the Technical Specifications section of this document from invited vendors. Prices quoted shall be all-inclusive and represent complete installation. The Bidder shall be responsible for all parts, labor and all other associated apparatus necessary to complete installation, test, and turn-over for acceptance to the VACHS the ChemoShield and the other materials listed. Include and supply all necessary labor, material, tools and equipment for the proper construction and installation of the below equipment in accordance with this document and related drawings. The winning contractor will have to honor the manufacture warranty and provide the required warranty services on a timely manner. The company should preferably be a local company so it can provide the warranty service if needed on a timely manner

2. Job Description
Purchase and installation of the below items.
1 One CS 600 ChemoSHIELD Containment Glovebox for Pharmacy Compounding Applications
Designed for Aseptic Compounding of Hazardous or Potent Pharmaceutical Compounds, Chemotherapy
Agents and IV Admixtures that can be harmful to Pharmacy Personnel features Construction: Stainless steel interior polished to a non-glare, easy to clean #4 finish. Exterior is baked enamel for superior resistance to laboratory chemicals. Interior Dimensions: The main working chamber has dimensions of 46" (L) x 24" (w) x 25" (h). The pass thru chamber has dimensions of 17-1/2" (L) x 24" (w) x 25"(h). Exterior Dimensions: Exterior dimensions are 75" (L) x 36" (w) x 90" (h). Main Chamber: The main working chamber is equipped
with 3 stet gloves to allow users to reach all interior areas with a gloved hand. Pass-Thru Chamber: The pass-thru chamber allows users to bring items into and out of containment safely. The pass-thru chamber is equipped with one ambidextrous glove to allow users to perform a surface decontamination on items being taken into or out of containment. HEPA Filters: Both chambers are equipped with HEPA filters on the supply and exhaust. Exhaust filters are safely removed via bag-out device insuring that dangerous compounds that may be present on the exhaust HEPA filter are safely contained. Negative Pressure: Each chamber perates at a negative differential pressure relative to the room. The standard configuration has the pass-thru chamber at a more negative pressure than the main chamber. Optional configuration has the main chamber more negative than pass-thru chamber. Please specify on ordering. Inter-chamber Door: A door separates the main working chamber from the pass-thru chamber. This door should only be opened when the external pass-thru door is closed Interlocks: The Inter-chamber door and the Pass-Thru door are interlocked so that they cannot be opened at the same time. This prevents accidental exposure to internal hazards. Pass-Thru Door: The pass-thru chamber is equipped with an external door to facilitate moving items into and out of
Containment. This door should only be opened when the inter-chamber door is closed. Uni-Directional Air Flow: The internal airflow is unidirectional (laminar) from top to bottom. This provides a "piston effect" that sweeps any generated particles directly to the exhaust HEPA filters. Exhaust Hook-up: Baker's chemoSHIELD is designed to hook up to your exhaust system. Because of the complex chemistries of today's drugs, some hazardous compounds may vaporize after being captured on the HEPA filter. HEPA
filters are not effective on vapors. Therefore, for your safety, Baker has designed the ChemoSHIELD to be connected to your exhaust ductwork system and vented to the outdoors. Exhaust Requirements: Connection to Baker's ChemoSHIELD is by 8" flange. The unit requires the exhaust system to have capacity of 375 cfm and have a negative static pressure of -2.0" water column at the exhaust connection. Lighting: The: Baker's ChemoSHIELD has interior cleanliness levels of better than Class 100 (100 measurable particles per cubic foot of air) [ISO Class 5]. The ChemoSHIELD will maintain your sterile interior environment after your standard decontamination method.
The ChemoSHIELD is equipped with an IV bar to facilitate hanging. Isolators meet USP Regulations 797

2.One Hydraulic lift base for CS600

3. Two Blowers. Sales and installation for in-line blower in polypropylenes with an explosion proof motor. Manufacture of stainless Steel box for Hepa Filter Manufacture of Stainless Steel box for motor Air Flow Certification Manufacture of duct and installation in Stainless Steel Electric Installation for the motor. HEPA filter certification

4. One SterilSHIELD Barrier Isolator (positive pressure) SterilSHIELD Barrier Isolator Includes an adjustable mounting stand. The work surface height can be set at 30 or 36 depending on preference for sitting or standing. The viewscreen top hinge supported by gas struts (one locking) permit full opening for instrument or equipment loading or cleaning as required. Not intended for use with biologically hazardous materials Constructed to UL standards for performance and safety StediVOLT Click here to download product literature Designed for Aseptic Compounding of Non-Hazardous Pharmaceuticals.
The Baker SterilSHIELD Barrier Isolator offers a positive pressure work area for pharmacy applications. Designed specifically for aseptic compounding of non-hazardous drugs and to meet or exceed the requirements of USP <797>, the SterilSHIELD creates a HEPA-filtered unidirectional airflow of better than ISO Class 5 (Class 100)

5. One Hydraulic Base for SterilShield SS400

6. One (11210905) IEC CL30 Series Benchtop Centrifuge

7. One (11210435) T 41 SWING-OUT ROTOR

8. One (11210436) SET OF 4 BUCKETS FOR T41 ROTOR

9. One (11175752) BUCKETS 4 X 50 ML CONICAL FOR T40
3. Specification ChemoSHIELD Barrier Isolator (negative pressure)
1. Cabinet shall maintain a negative pressure in both the work area and the interchange.
2. Cabinet shall provide better than ISO Class 5 (Class 100) HEPA-filtered air across 100% of the work surface and in the interchange.
3. Filtered unidirectional airflow provides better than ISO Class 5 (Class 100) air cleanliness conditions within the chamber. Gas-tight construction coupled with negative pressure prevents contaminants from the outside from entering the chamber and contaminants from the work area from migrating to the outside.
4. Work surface airflow shall be from top-to-bottom to achieve a piston effect, sweeping particulates from the work area to the HEPA filter.
5. Cabinet interchange negative pressure shall be visually verifiable by an independent magnehelic gauge on the main control panel.
6. The cabinet interchange outer door shall be of clear-view, shatter-proof polycarbonate with left-hand swing.
7. The cabinet interchamber door to the work area shall be 12 Ga., 316 SS with hinge for opening.
8. Cabinet work area negative pressure shall be visually verifiable by an independent magnehelic gauge on the main control panel.
9. The hinged viewscreen shall be slanted at an angle of 10 from vertical.
10. The viewscreen shall be capable of fully opening to load equipment or instruments.
11. The hinged viewscreen shall have a key lock to prevent unauthorized opening.
12. Viewscreen shall be constructed of shatterproof clear polycarbonate.
13. Viewscreen shall have three gloveports for the CS600. Two gloveports for the CS500. Gloves shall be nitrile rubber. Gloves are ambidextrous.
14. Stainless steel gloveports shall be oval to permit easy reach to all work surface areas.
15. The pass-thru interchange shall have one oval gloveport with a nitrile ambidextrous rubber glove.
16. All contaminated ducts, plenums and work area side walls shall be permanent metal construction and maintained under negative pressure.
17. Dimensions of the cabinet interior shall be apportioned as follows:
a. Work area:
CS500 - 31"W x 24"F x 25"H
CS600 - 46"W x 24"F-B x 25"H
b. Interchange:
CS500/600 - 17"W x 24"F-B x 25"H
18. Cabinet shall employ plenum to provide more uniform airflow to the supply filter.
19. Supply HEPA filters shall be front-loading.
20. Exhaust HEPA filters shall be bag-out design.
21. Plenum assembly shall be provided to allow the filters to be directly clamped to the plenum against a closed-cell neoprene gasket. The plenum applies force to full perimeter of filters, rather than point force.
22. Complete unit shall be certified by Underwriters Laboratory (UL) for electrical, fire and personal safety.
23. Cabinet exterior construction:
a. Seal panels of 16-gauge, cold-rolled steel
b. Dress panels of 18-gauge, cold-rolled steel, painted PermaWhite.
24. Cabinet interior (work area) construction shall be one-piece, 16-gauge, Type 316 stainless steel, with a smooth, 7/16" radius between rear and side walls, and easily cleanable, radiused corners on the work surface tray.
25. Work area side walls and rear wall to be one-piece construction.
26. A straight back wall shall be provided to maximize work area and easily accommodate pharmacy equipment.
27. Work area shall be outfitted with protected work area duplex outlet with weatherproof cover and circuit breaker.
28. Cabinet shall have a unitized drain pan with 7/16" radius on all sides and a fully-removable work surface to facilitate cleaning.
29. A Type 316 stainless steel air diffuser and filter protector shall be provided in work area and pass-thru chamber (Interchange).
30. Each unit, before shipping, shall have a complete physical test to assure cabinet meets performance requirements. A copy of this test will be provided with the unit.
31. External adjustable damper provided to compensate for changing resistance of exhaust and supply filters.
32. A single power cord and plug shall be provided for electrical power source.
33. The unit shall have standard HEPA filters for a protection effectiveness of 99.99% when filtering particles of 0.3 micron size.
34. The unit shall be configurable for use while sitting or standing.
35. The unit shall include an adjustable stand with telescoping legs to allow the work surface height to be fixed at 36" or 45".
36. Cabinet shall pass a 30 minute leak test per the American Glove Box Society standard.

4. Warranty
The Baker Company, Inc., expressly represents and warrants all goods (a) to be as specified (and described) in The Baker Company catalogs and literature, and (b) to be free under normal use, service and testing (all as described in The Baker Company catalogs and literature) from defects in material and workmanship for a period of thirty-six months from the invoice date.
The exclusive remedy for any breach or violation of this warranty is as follows: The Baker Company, Inc., will F.O.B Sanford, Maine, furnish without charge repairs to or replacement of the parts or equipment which proved defective in material or workmanship. No claim may be made for any incidental or consequential damages.
THIS WARRANTY IS EXPRESSLY IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE UNLESS OTHERWISE AGREED IN WRITING SIGNED BY THE BAKER COMPANY. (THE BAKER COMPANY SHALL NOT BE RESPONSIBLE FOR ANY IMPROPER USE, INSTALLATION, SERVICE OR TESTING OF THE GOODS.)
5. Quality Assurance: Before accepted as completed all test and certifications need to be done and provided to the service Nuclear Medicine or designee.. Documentation will be provided to VA COTR.

6. Qualifications: A. Manufacturer: 1.The products specified in this specification shall be supplied by a single manufacturer 2. The contractor shall utilize the authorized manufacturer components and distribution channels in provisioning this Project. 3. Contractor shall have a minimum of five (5) years of recent experience on installation and warranty servicing of this or similar type and size equipment. 4. The contractor shall be experience in all aspects of this work and shall be required to demonstrate direct experience on recent systems of similar type and size. 5. The contractor shall own and maintain the tools and equipment approved for successful installation and testing of these equipment. 6. The contractor shall have personnel who are adequately trained in the usage of such tools and equipment. 7. Contractor if requested shall submit a resume of qualification with the Contractor's proposal indicating the following: a. A list of recently completed projects of similar type and size with contact names and telephone numbers for each. b. A list of test equipment proposed for use in verifying the installed integrity and appropriate certifications.. c. A technical resume of experience for the contractor's Project Manager and on-site installation supervisor who will be assigned to this project. d. A list of technical product training attended by the contractor's personnel that will install the ChemoShield and other equipment contractor's work. 7. Product warranty and application assurance: Materials and workmanship hereinafter specified and furnished shall be fully guaranteed by the bidder as per manufacture warranty after installation and acceptance by The Customer shall be corrected by The Bidder at no additional cost to The Customer. The Bidder shall promptly, at no cost to The Customer, correct any nonconforming or defective work within the time limiotation of the warranty provided by the manufacture. The period of The Bidder's warranty (ies) for any items herein are not exclusive remedies, and The Customer has recourse to any warranties of additional scope given by The Bidder to The Customer and all other remedies available at law or in equity. The Bidder's warranties shall commence with acceptance of/or payment for the work in full. . The Bidder shall pass along to The Customer any additional warranties offered by the manufacturers, at no additional costs to The Customer. This warranty shall in no manner cover equipment that has been damaged or rendered unserviceable due to negligence, misuse, acts of vandalism, or tampering by The Customer or anyone other than employees or agents of The Bidder. The Bidder's obligation under its warranty is limited to the cost of repair of the warranted item or replacement thereof, at The Bidder's option. Insurance covering said equipment from damage or loss is to be borne by The Bidder until full acceptance of equipment and services. 8. SECURITY REQUIREMENTS: Contractor personnel must display Contractor provided picture identification. Other VA Vendor Policies may also apply. The contractor shall have in place, and available to the Medical Center staff, security and contingency plans for all systems providing service to the VACHS. Contractor's policies and procedures must be in accordance to applicable rules and regulations (Privacy Act, FOIA, etc) pertaining to Information security. 9. LAYOUT: The layout and further information can be provided by MR David Cornier telephone 787 641-7582
10. SAFETY REQUIREMENTS: In performance of this contract the Contractor shall take such service safety precautions as the Contracting Officer or his/her designee may determine to be reasonably necessary to protect the lives and health of occupants of the building. The Contracting Officer or his/her designee will notify the Contractor of any non-compliance with the foregoing provisions and the action to be taken. The Contractor shall, after receipt of such notice, immediately correct the condition to which attention has been directed. Such notice, when served on the Contractor or his representative at the site of work, shall be deemed sufficient for the purpose aforementioned. If the Contractor fails or refuses to comply promptly, the Contracting Officer may issue an order stopping all or any part of the work and hold the Contractor in default. 11. Only the Purchasing Agent is authorized to make commitments or issue changes which will affect the price, quantity, quality or terms of this order. The contractor must provide a contact person whom VA may contact during the performance of this contract for prompt action on matters pertaining to the administration of the order. A notice received by this contact person will be considered to be a notice received by the Contractor. THE FULL TEXT OF A CLAUSE MAY BE ACCESSED ELECTRONICALLY AT THESE ADDRESSES: www.acquisition.gov/far/index.html; www.va.gov/oamm/oa/ars/policyreg/vaar/index.cfm. The quotation shall be e-mailed to the attention of the Jose R. Sierra at jose.sierra-colon@va.gov. NO FAX WILL BE ACCEPTED.
Quote due date is December 11, 2008 at 11:30am (Puerto Rico local time).
52.212-1 Instructions to Offerors-Commercial Items. (June 2008); 52.212-3 Offeror Representations and Certifications-Commercial Items. (June 2008) [The offeror shall submit a completed representations and certifications along with the quotation]; 52.212-4 Contract Terms and Conditions-Commercial Items. (Oct 2008); 52.225-13 Restrictions on certain foreign purchases (Jun 2008);52.232-8 Discounts for prompt payment (FEB 2002); 52.246-1 Contractor Inspection requirements (APR 1984); 52.247-64 Preference for privately owned U.S. Flag Com. Vessels (Feb 2006); 52.232-18 Availability of funds (APR 1984); 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items. (Oct 2008) The following Clauses applies: [52.219-6, Notice of Total Small Business Set-Aside (June 2003), 52.219-28, Post Award Small Business Program Re-representation (June 2007), 52.222-3, Convict Labor (June 2003), 52.222-21, Prohibition of Segregated Facilities (Feb 1999), 52.222-26, Equal Opportunity (Mar 2007), 52.222-36, Affirmative Action for Workers with Disabilities (Jun 1998), 52.222-39, Notification of Employee Rights Concerning Payment of Union Dues or Fees (Dec 2004), 52.222-50, Combating Trafficking in Persons (Aug 2007), 52.225-1, Buy American Act-Supplies (June 2003),52.225-3, Buy American Act-Free Trade Agreements-Israeli Trade Act (Aug 2007), 52.225-13, Restrictions on Certain Foreign Purchases (June 2008), 52.232-34, Payment by Electronic Funds Transfer-Other than Central Contractor Registration (May 1999), 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services-Requirements (Nov 2007), 52.237-11, Accepting and Dispensing of $1 Coin (Sept 2008)]; This FAR Clause is included in full text and should be completed by the offeror: 52.222-52 Exemption from Application of the Service Contract Act to Contracts for Certain Services-Certification (Nov 2007), (a) The offeror shall check the following certification: CERTIFICATION THE OFFEROR [ ] DOES OR [ ] DOES NOT CERTIFY THAT-
(1) The services under the contract are offered and sold regularly to non-Governmental customers, and are provided by the offeror (or subcontractor in the case of an exempt subcontract) to the general public in substantial quantities in the course of normal business operations;(2) The contract services are furnished at prices that are, or are based on, established catalog or market prices. An "established catalog price" is a price included in a catalog, price list, schedule, or other form that is regularly maintained by the manufacturer or the offeror, is either published or otherwise available for inspection by customers, and states prices at which sales currently, or were last, made to a significant number of buyers constituting the general public. An "established market price" is a current price, established in the usual course of ordinary and usual trade between buyers and sellers free to bargain, which can be substantiated from sources independent of the manufacturer or offeror;(3) Each service employee who will perform the services under the contract will spend only a small portion of his or her time (a monthly average of less than 20 percent of the available hours on an annualized basis, or less than 20 percent of available hours during the contract period if the contract period is less than a month) servicing the Government contract; and (4) The offeror uses the same compensation (wage and fringe benefits) plan for all service employees performing work under the contract as the offeror uses for these employees and for equivalent employees servicing commercial customers. (b) Certification by the offeror as to its compliance with respect to the contract also constitutes its certification as to compliance by its subcontractor if it subcontracts out the exempt services. If the offeror certifies to the conditions in paragraph (a) of this provision, and the Contracting Officer determines in accordance with FAR 22.1003-4(d)(3) that the Service Contract Act- (1) Will not apply to this offeror, then the Service Contract Act of 1965 clause in this solicitation will not be included in any resultant contract to this offeror; or
(2) Will apply to this offeror, then the clause at FAR 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services-Requirements, in this solicitation will not be included in any resultant contract awarded to this offer, and the offeror may be provided an opportunity to submit a new offer on that basis.(c) If the offeror does not certify to the conditions in paragraph (a) of this provision- (1) The clause of this solicitation at 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services-Requirements, will not be included in any resultant contract to this offeror; and (2) The offeror shall notify the Contracting Officer as soon as possible if the Contracting Officer did not attach a Service Contract Act wage determination to the solicitation. (d) The Contracting Officer may not make an award to the offeror, if the offeror fails to execute the certification in paragraph (a) of this provision or to contact the Contracting Officer as required in paragraph (c) of this provision.
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Solicitation 1

Type:
Solicitation
Posted Date:
May 11, 2009
:
Department of Veterans Affairs;P&C Business Office;Tres Rios Blvd;27 Gonzalez Giusti Ave, Suite 600;Guaynabo PR 00968
:
VA CARIBBEAN HEALTH CARE SYSTEM;CALLE CASIA #10;SAN JUAN PR
00921
US
:
Rolando ArceTEL 787-781-8700 X4778

Purchasing Agent