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FBO DAILY - FEDBIZOPPS ISSUE OF OCTOBER 04, 2014 FBO #4697
DOCUMENT

66 -- TOSOH GLYCO HEMOGLOBIN A1c ANALYZER To procure all necessary reagents, papers, printers, columns filters, calibrators and controls to perform the measurement of hemoglobin A1c. - Justification and Approval (J&A)

Notice Date

10/2/2014
 

Notice Type

Justification and Approval (J&A)
 

NAICS

334516 — Analytical Laboratory Instrument Manufacturing
 

Contracting Office

Department of Veterans Affairs;VA Caribbean Healthcare System;Administrative Building;#10 Calle Casia Suite #4M440;San Juan PR 00921-3201
 

ZIP Code

00921-3201
 

Solicitation Number

VA24814Q1363
 

Archive Date

10/11/2014
 

Point of Contact

JOSE R. SIERRA
 

E-Mail Address

jose.sierra-colon@va.gov
(Jose.Sierra-Colon@va.gov)
 

Small Business Set-Aside

N/A
 

Award Number

V797D-40130 VA248-15-F-4957
 

Award Date

10/1/2014
 

Description

LIMITED SOURCES JUSTIFICATION ORDER >$3,000 FAR PART 8.405-6(b) 2237 Transaction # or Vista Equipment Transaction #: 672-15-1-045-0005 This acquisition is conducted under the authority of the Multiple Award Schedule Program. The material or service listed in par. 3 below is sole source, therefore, consideration of the number of contractors required by FAR Subpart 8.4 - Federal Supply Schedules, is precluded for the reasons indicated below. Restricted to the following source: Provide original manufacturer's name for material or contractor's name for service. (If a sole source manufacturer distributes via dealers, ALSO provide dealer information.) Manufacturer/Contractor: TOSOH BIOSCIENCE INC. Manufacturer/Contractor POC & phone number: George Eskew, National Sales Manager, (305)822-7815 Mfgr/Contractor Address: 6000 Shoreline Courts, Suite 101 South San Francisco, CA 940801-1913 Dealer/Rep address/phone number: 305-822-7815 1 The requested material or service represents the minimum requirements of the Government. (1) AGENCY AND CONTRACTING ACTIVITY:Department of Veterans Affairs VA Caribbean Healthcare System 10 Casia Street San Juan, PR 00926 VISN:08 (2) NATURE AND/OR DESCRIPTION OF ACTION BEING APPROVED: This is a request for Other than Full and Open competition Only one Responsible Source and no Other Supplies or Services will Satisfy Agency, Requirements per FAR 6.302-1 for a Cost per reportable test contract for an HPLC Glycohemoglobin Analyzer contract for clinical chemistry under NAC Contract V797D-40130 by Schedule 66. The analysis and operation is performed by the Pathology and Laboratory Service Chemistry Section at the VA Caribbean Healthcare System, Medical Center in San Juan P.R. for a period of 5 years. The VA Caribbean Healthcare System, Medical Center in San Juan P.R. and the Outpatient Satellite Clinics. Contract Service is requested for October 1st 2014 through September 30, 2019. (3)(A) DESCRIPTION OF THE SUPPLIES OR SERVICES REQUIRED TO MEET THE AGENCY'S NEED: To procure all necessary reagents, papers, printers, columns, filters, calibrators and controls to perform the measurements of hemoglobin A1c in whole blood specimens for an existing Tosoh Bioscience G-8 Analyzer located at our VA Caribbean Healthcare System Pathology and Laboratory Medicine Service at the Chemistry Section. The existing Automated Glyco hemoglobin Analyzer G8 is intended for in vitro diagnostic use for the measurement of hemoglobin A1cj. The stable A1c offers a very accurate indication of the patient's long-term diabetic control over the last two or three months. The High Performance Liquid Chromatography (HPLC) methodology is the gold standard for HbA1c measurement. Tosoh Bioscience will provide: Instrumentation, reagents, calibrators, controls, columns and the preventive maintenance service and warranty for the equipment during the term of the agreement. (b)ESTIMATED DOLLAR VALUE: $267,720.00 (c)REQUIRED DELIVERY DATE: October 1st, 2014. The estimated period of performance will be for five (5) years after the notice to proceed which will cover a base period of twelve (12) months and four (4) additional option years of twelve (12) months each year. (4)IDENTIFICATION OF THE JUSTIFICATION RATIONALE (SEE FAR 8.405-6), AND IF APPLICABLE, A DEMONSTRATION OF THE PROPOSED CONTRACTOR'S UNIQUE QUALIFICATIONS TO PROVIDE THE REQUIRED SUPPLY OR SERVICE. (CHECK ALL THAT APPLY AND COMPLETE) 1Specific characteristics of the material or service that limit the availability to a sole source (unique features, function of the item, etc.). Describe in detail why only this suggested source can furnish the requirements to the exclusion of other sources. "The G-8 Analyzer already in place is from Tosoh and all the reagents, columns, calibrators and controls to be use for analysis must be from Tosoh because the Joint Commission and the College of American Pathologist (CAP) would not accredited the Instrument if we use other companies' reagents. The current/existing counter top for TOSOH equipment has the ability to place blood samples in multiple racks which Roche equipment does not facilitate. With Tosoh's equipment we may place all the tests to be analyzed at the same time without any technologist intervention versus with Roche's instrument that we have the limitation of sample capacity. "A market research was performed and this evaluation demonstrated that the option that complies with the majority of our requirements at the VA Caribbean Healthcare System is Tosoh Bioscience G-8. Also, instrumentation from another one (1) company were evaluated and compared. Our daily volume is approximately 250 patient samples including all our Satellite Clinics (See market research supporting document). Our breakdown on samples are approximately 4,941 test per month and the laboratory runs this samples from Monday through Friday from 0800 AM to 0400 PM. (4,941/20 days= 247 test per day). There are three (3) Chemistry Technicians for the night and weekend shift but neither are trained to use the Analyzer since they are to work on emergencies and other type of laboratory tasks by which the Analyzer is not used during their shift. The bulk of samples arrive from 0230PM through 0400PM from our Satellite Clinics (Mayaguez, Ponce, Arecibo, Utuado and Guayama Outpatient Clinics). Tosoh's Analyzer performs each test in approximately 1.6 per minute. By adding the Glyco Test to the current chemistry analyzer (Roche Brand) this can cause a delay in the chemistry test processing and may create a bottleneck in the analyzer since the Roche loader capacity is 75 samples at the time versus Tosoh's loader that will hold 290 samples at a time. "Tosoh's equipment can be continuously fed onto the sampler loader from primary tubes with cap piercing. These piercing are made by the equipment during process. Consequently, this will avoid any contact with the blood samples preventing any infection to be transmitted to our Medical Technologist by opening the opening the caps during the process. "The VA Caribbean Healthcare System daily patient test volume is 275 approximately including the Satellite clinics of Ponce, Mayaguez, Arecibo, Utuado and Guayama. Therefore, productivity of samples by this equipment is more cost effective due to the fact that we have limited staff at this moment in our VACHS Chemistry Laboratory Section. Providing overtime at this moment to our limited staff will not be cost effective and is considered to be a substantial duplication of effort and cost to the Government. 0A patent, copyright or proprietary data limits competition. The proprietary data is: 1These are "direct replacements" parts/components for existing equipment. This includes all necessary reagents, papers, printers, columns, filters, calibrators and controls to perform the analysis. ? 0The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. Describe the equipment/function you have now and how the new item/service must coordinate, connect, or interface with the existing system. 0The new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures. 0An urgent and compelling need exists, and following the ordering procedures would result in unacceptable delays. (5) DESCRIBE WHY YOU BELIEVE THE ORDER REPRESENTS THE BEST VALUE CONSISTENT WITH FAR 8.4 TO AID THE CONTRACTING OFFICER IN MAKING THIS BEST VALUE DETERMINATION: The anticipated price to the Government is $267,720.00 for five (5) years after the notice to proceed which will cover a base period of twelve (12) months and four (4) additional option years of twelve (12) months each year and the price seems fair and reasonable in comparison with Purchase order 672A40006. This order represents the Best Value in the market because it greatly increases laboratory efficiency and productivity according to our specific needs. Our Chemistry section handles a high workload and volume of approximately 60,000 A1c tests on a yearly basis. One of the most important features of this instrument is the loader module which significantly improve our laboratory workflow because eliminates the variation that can occur with methodologies and it is the gold standard for this analysis in the market. This is crucial because when physicians evaluate these results, any variation could be significant and could represent a change in the patient prognosis and treatment. (6) DESCRIBE THE MARKET RESEARCH CONDUCTED AMONG SCHEDULE HOLDERS AND THE RESULTS OR A STATEMENT OF THE REASON MARKET RESEARCH WAS NOT CONDUCTED: 1) A market research was performed on GSA under NAC schedule 66 by the Chemistry Supervisor in January 2014 through the internet and CAP Today Chemistry Analyzers Report to acquire the information about the Automated Chemistry Analyzers available at this moment that fulfill our laboratory requirements and Accreditation Agencies (CAP and Joint Commission) regulations and this evaluation demonstrate that the option that complies with the majority of our requirements in the San Juan VA is the Tosoh G-8 Glyco hemoglobin Analyzer under NAC contract V797D-40130. 2) A Request for Information was announced through Federal Business Opportunity and GSA. One interested vendor answered the Request for Information. 3) Tosoh G-8 sample Loader has the capacity for 290 patient samples in comparison with the ROCHE Diagnostics equipment holds only 75 patient samples at the time. 4)The Instrument validation (Precision & Correlation studies and Linearity's) was performed for the Tosoh G-8. Other instrumentation will require these studies to be performed. 5) The Bio-Rad patient report requires a LaserJet printer for individual reports which results in extra consumables expenses for toner and paper. In contrast, Tosoh reports are printed in thermal paper roll provided by the company. (7) ANY OTHER FACTS SUPPORTING THE JUSTIFICATION: Keeping the current equipment with this sample loader capacity of 290 tubes provides the Laboratory a truly walk-away system resulting in an effective and efficient workflow. Our volume is 275 patient samples approximately. These tubes (125-150) are all placed on the instrument and are analyzed without any technologist intervention until next day when it is verified in Vista. With another instrument we have the limitation of sample capacity, therefore a technologist would have to stay longer to place all the samples incurring in extra expenses of overtime or compensatory time. (8) A STATEMENT OF THE ACTIONS, IF ANY, THE AGENCY MAY TAKE TO REMOVE OR OVERCOME ANY BARRIERS THAT LED TO THE RESTRICTED CONSIDERATION BEFORE ANY SUBSEQUENT ACQUISITION FOR THE SUPPLIES OR SERVICES IS MADE: To foster competition for future acquisitions of the supplies or services being acquired would be necessary to have an instrument that can hold the same amount or more of the samples that can provide the Laboratory a truly walk-away system so it can results in a more effective an efficient workflow and in a much more cost effective for the Government by not incurring in any extra expenses of overtime or compensatory time. (9) REQUIREMENTS CERTIFICATION: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. (This signature is the requestor's supervisor, fund control point official, chief of service or someone with responsibility and accountability.) *******************************************************************************************
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/SJVAMC672/SJVAMC672/VA24814Q1363/listing.html)
 

Document(s)

Justification and Approval (J&A)
 

File Name: V797D-40130 VA248-15-F-4957 V797D-40130 VA248-15-F-4957_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1663507&FileName=V797D-40130-001.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1663507&FileName=V797D-40130-001.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN03540797-W 20141004/141002234744-3817fe0a6332e53342ce0a0e71b126e8 (fbodaily.com)
 

Source

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

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