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FBO DAILY - FEDBIZOPPS ISSUE OF AUGUST 13, 2016 FBO #5377
DOCUMENT

66 -- VA258-16-AP-2636 ROTEM - Attachment

Notice Date

8/11/2016
 

Notice Type

Attachment
 

NAICS

325411 — Medicinal and Botanical Manufacturing
 

Contracting Office

Department of Veterans Affairs;VISN/18PHX;777 E. Missouri, Suite 300;Phoenix AZ 85014
 

ZIP Code

85014
 

Solicitation Number

VA25816N0799
 

Response Due

8/17/2016
 

Archive Date

8/27/2016
 

Point of Contact

Christina Harris
 

Small Business Set-Aside

Service-Disabled Veteran-Owned Small Business
 

Description

THIS IS A SOURCES SOUGHT NOTICE. This is not a request for proposals. A solicitation will not be issued at this time. The Department of Veterans Affairs, Southern Arizona VA Health Care System (SAVAHCS) in Tucson, AZ has a requirement for Thromboelastogram and Platelet Aggregometer Analyzer as well as reagents, controls, calibration materials, disposables, and any other pertinent consumables in accordance with the statement of work outlined below. The intent of the procurement is to award a firm-fixed price contract. SOUTHERN ARIZONA VA HEALTH CARE SYSTEM (SAVAHCS): VAMC: 3601 S 6th Ave, Tucson, AZ 85723 The applicable NAICS code is 325411 Medicinal and Botanical Manufacturing. Small Business manufacturers for this NAICS code have a size standard of 1,000 employees. The resulting contract will be a firm fixed price order. The term of the contract is intended to be for a base of one year and four subsequent option years. It is anticipated that a Request for Quotes will be issued in August 17, 2016. Award of a firm fixed price contract is contemplated by September 30, 2016. This notice is published 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 August 11, 2016 at 4:00 pm AZ time. 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 Christina.Harris@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 SCOPE The Southern Arizona VA Healthcare System Diagnostics Division requires a coagulation analyzer system to perform whole blood coagulation testing for patients during procedures such as open heart or major vascular surgery. This system informs the physician of the whole blood ability to form a clot in a manner more closely resembling the actual in vivo blood clotting dynamics of the patient. This system allows for more accurate usage of limited and expensive commodities such as platelet concentrates, cryoprecipitate, plasma, and packed red cells. The requested system will afford better patient outcomes due to more timely and accurate administration of proper blood components and anticoagulants during and immediately after procedures. GENERAL REQUIREMENTS 1)The vendor shall provide the most current coagulation combined platforms available, with an ability to detect and minimize the effects of interfering substances such as lipemia, icterus, and hemolysis. 2)The vendor shall provide the facility with Food and Drug Administration (FDA) 510K approved analyzer/equipment, reagents, controls, calibration materials, disposables, and any consumable parts necessary for analyzing/testing on both the primary and back-up analyzers. 3)The system shall be a well characterized system with multiple studies and have a track record of performance no less than one year. 4)Equipment shall have accurate capability of monitoring reagent usage and provide reagent inventory upon request, in real time. 5) The vendor shall provide/install any routine and special items required to operate/maintain the equipment/analyzer in optimal condition such as but not limited to: printers, water supply, drainage systems, UPS, and surge suppressors. Also, to include any engineering controls necessary to maintain proper operating temperature. Any items excluded by the vendor shall be delineated in their technical proposal. The cost of the excluded items shall be incorporated in the price proposal. EQUIPMENT FUNCTIONALITY 1)The analyzers shall have a comprehensive QC Program for all tests which includes at a minimum the following options: "QC files may be edited or corrected for errors manually with/without password protection "On-board quality control data storage and reporting capabilities "The ability to view and print daily and monthly QC results "Westgard rules (or other QC acceptance criteria) built in 2)System shall have user defined reflex and repeat testing capability. 3)System shall perform tests on 3.2% citrated plasma. 4)System shall have a design that removes the possibility of reagent or sample carryover. Carryover studies shall be performed, as applicable, as part of the initial evaluation of the instrument. Vendor shall provide interpretation of raw data for each instrument installed. Vendor shall also provide documented evidence confirming the system design removes the possibility of any reagent or sample carryover. 5)System shall have positive sample identification to reduce possible sources of error/delay and to improve laboratory efficiency. 6)Equipment shall be able to store and retransmit records (24 hours of maximal instrument throughput) in case of interface downtime. 7)Interfacing requirements to be provided by the vendor: "Instrument LIS physical connection and translation (drivers). Must be compatible with Data Innovations Technologies system. "Any additional hardware and software needed to interface the analyzer and technical assistance with interfacing the analyzer 8)Vendor shall list the reagents and calibrators that require any additional preparation prior to use such as warming/mixing/reconstitution. INSTALLATION AND VALIDATION 1)Vendor shall move instruments, free of charge, to final testing location upon completion of validation process. 2)Vendor shall provide the facility with all cross-over supplies and reagents needed at installation and during training of VA staff. Test counts for billing will begin after review/approval of all correlation/linearity studies performed at installation. 3)During installation/set-up, and when bringing new tests on-line, a technical support specialist shall perform all validation studies including: installation/set-up, correlation studies (evaluation/comparison data sufficient to satisfy CAP standards) normal range studies, staff training, in-services to laboratory personnel and clinicians, and assist with any methodology problems and questions. This service shall be available during regular office hours on a 5 days/week (M-F 8am-5pm) basis via customer telephone support. 4)Throughout the life of the agreement, the vendor shall provide 24/7 customer telephone support assistance to the user in setting up and maintaining/trouble shooting user-defined TRAINING 1)The vendor shall provide (on-site or off-site) primary user training for a minimum of two users per instrument with on-site training available to remaining users on all tours with competency assessment performed and documented. Primary user training shall be arranged by the vendor and include all costs of off-site training, i.e., transportation (air and ground), room and board, etc. 2)Vendor shall provide/install/train users on any data management system with either off site or in house training. 3)Vendor shall provide all necessary procedure manuals, troubleshooting manuals and operator manuals (also available on computer disk format). Procedures shall be in the Clinical and Laboratory Standards Institute (CLSI) format. SERVICE AND MAINTENANCE 1)Instrument support service shall provide assistance with troubleshooting and repair of the analyzers. On-site service shall be available Monday through Friday during regular business hours (8am-5pm) 2)The vendor shall provide a twenty-four hour/seven-day service hotline with technical support. 3)The vendor shall provide a preventative maintenance schedule to include timely scheduled vendor preventative maintenance visits as required. 4)The vendor shall supply engineering controls if necessary for any heat, humidity, or noise issues that may result from use of the proposed system. 5)Vendor shall provide standard and routine software and hardware upgrades to the equipment hardware and operating systems, without additional charge to the Government (e.g. upgrades that correct or improve either the mechanical operations or software of the system and would keep the instrument performing optimally). 6)Vendor shall define daily, weekly, monthly, and as needed maintenance and the time required to perform each maintenance task. Vendor shall indicate which tasks are user level and which are service level. 7)For reagents with hazardous constituents, vendor shall provide a mechanism for the Laboratory to meet local discharge requirements. The vendor shall supply information regarding any hazardous chemicals OTHER 1)Assessment of testing needs/menus shall be evaluated as needed by the laboratory with communication to the vendor to receive pricing. There shall be easy assimilation for new tests into the pricing test lists without the need for line item additions to the agreement. 2)Request for instrumentation upgrades or replacement due to workload increase, excessive instrumentation failures/malfunctions, breakdowns, or service calls shall be evaluated as needed/annually by the laboratory with communication to the vendor for modification of the contract. A high incidence of such problems with any equipment/analyzer supplied may indicate probable non-compliance with the terms of this contract and will entitle the facility/clinic to its replacement with another analyzer(s) that can produce the required criteria satisfactorily to the user. 3) The vendor shall remove all equipment within 90 days after notification of the expiration of the terms of this agreement but not until the completion of new vendor's equipment installation inclusive of completed cross over studies. Vendor shall be responsible for removing the hard drive and turning it over to the VA for destruction prior to removal of any analyzer. 4)The vendor shall reimburse the facility for any costs/supplies related to tests sent to a referral laboratory when testing is not available through no fault of the facility due to reagent problems, other product issues, instrumentation failure, or other factors. The assessed damages shall be applied to the invoice in the form of a credit or deduction. 5)In the event that the any consumable, reagent, or other necessary item are found to be defective and unsuitable for use with the vendor's equipment, or the contractor has failed to comply with the requirements for routine supply delivery, the contractor shall deliver the consumable supplies within a period of 24 hours after receipt of the verbal order for priority delivery from the facility. If either circumstance has occurred, the vendor shall deliver to the facility, in the most expeditious manner possible, without additional cost to the facility, the necessary consumables in sufficient quantity so testing is not delayed. 6)This contract shall "be green," by eliminating, minimizing or mitigating adverse environmental impacts. The following chemicals have been targeted by the EPA specifically for reductions and feasible elimination. Please list any reagents (and in what concentration) that contain the following chemicals: BenzeneCarbon tetrachloride ChloroformDischloromethane Methyl ethyl ketoneToluene Methyl isobutyl ketoneXylenes Tetrachloro-ethyleneCadmium 1,1,1-Trichloro-ethaneChromium Trichloro-ethyleneCyanide LeadMercury Nickel AUTOMATION: NA
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/PhVAMC/HMC/VA25816N0799/listing.html)
 

Document(s)

Attachment
 

File Name: VA258-16-N-0799 VA258-16-N-0799.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2938611&FileName=VA258-16-N-0799-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2938611&FileName=VA258-16-N-0799-000.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: Southern Arizona VA Health Care System;3601 S. 6th Avenue

Zip Code: 85723
 

Record

SN04219139-W 20160813/160811234553-862cbd4f49ecaf71b70f2cc1b52307a2 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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