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FBO DAILY - FEDBIZOPPS ISSUE OF AUGUST 18, 2018 FBO #6112
DOCUMENT

Q -- Cobas 6800 HIV/HCV Laboratory Diagnostic Analyzer and Test K - Attachment

Notice Date

8/16/2018
 

Notice Type

Attachment
 

NAICS

334516 — Analytical Laboratory Instrument Manufacturing
 

Contracting Office

Department of Veterans Affairs;NCO 17 North Texas Healthcare System;NCO 17 Network Contracting Activity;4500 S. Lancaster Road;Dallas TX 75216
 

ZIP Code

75216
 

Solicitation Number

36C25718Q9080
 

Response Due

8/23/2018
 

Archive Date

10/22/2018
 

Point of Contact

Grace Barr
 

Small Business Set-Aside

N/A
 

Description

2 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, North Texas VA Health Care System (NTXVHCS) at 4500 S. Lancaster Rd, Dallas, Tx 75216 is requesting the leasing of a HCV, HBV(if available), and HIV analyzer and purchase of viral load reagent kits The intent of the procurement is to award a base plus 4 option years contract. The applicable NAICS code is 334516- Analytical Laboratory Instrument Manufacturing. Small Business manufacturers for this NAICS code have a size standard of 1,250 employees.   The resulting contract will be a base plus 4 option years, firm fixed price contract. The period of performance shall begin no later than 10/01/2018 and shall be active through 9/30/2023. 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) or Small Businesses (SB) 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 (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 23, 2018 at 9am ET 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 directly via eBuy and copy Grace.Barr@va.gov. NO ADDITIONAL INFORMATION IS AVAILABLE OTHER THAN WHAT IS NOTED HEREIN. STATEMENT OF WORK Purpose Requesting the leasing of a HCV, HBV(if available), and HIV analyzer and purchase of viral load reagent kits, consumables, supplies, yearly maintenance agreement, and annual off-site customer training. Scope The contractor will provide the Analyzer, regents, supplies, and consumables. The contractor will provide technical support and guidance, and one annual off-site training event for testing personnel. All reporting is automatic. No manual reading is required. Automated (interfaced) reporting eliminates the need for manual interpretation and manual data entry and the incidence of interpretation errors. Technical support is available via telephone during business days (and by message center after hours) to provide troubleshooting assistance or to answer testing inquiries. On-site technical support is available for escalations within 48 hours. Pathology & Laboratory Medicine Service (P&LMS) at the Dallas VA North Texas Health Care System (VANTHCS) will order reagents and supplies from The provider Diagnostics as needed to perform Hepatitis C, Hepatitis B, and HIV viral load testing on the Analyzer, which will be located in the P&LMS, Dallas VANTHCS. Location The Analyzer will be located and testing will be performed in the Molecular Diagnostics section of Client Services & Immunopathology, P&LMS, Dallas VANTHCS. Performance Requirements Maintenance: The Contractor shall perform preventive maintenance at intervals specified by the manufacturer to ensure proper equipment performance. Maintenance includes the following: 4.1.1 Inventory and recording of systems components. 4.1.2 Monthly deliverables shall be received in full. 4.1.3 Testing all components for proper test performance. Equipment shall reproduce results according to manufacturer s specifications. 4.1.4 After Preventative Maintenance (PM), the contractor shall submit a detailed work report for notice at no additional cost to the government. 4.1.5 Delivery of PM parts or materials: The contractor shall provide all preventive service materials at no additional cost the government. 4.2. Repairs and Support. 4.2.1 Technical Support: Support Personnel will be available by telephone from 8:00 a.m. to 5:00 p.m. Pacific Standard Time each business day, and live representatives at via the contractor s message center will be available by telephone at all other times.   4.2.2.1 On-site Repairs: With respect to any technical support issue that the contractor determines to require on-site support at the Customer s facility, The provider will dispatch one or more Support Personnel to such facility, normally within 48 business hours after The provider has logged the corresponding Customer Support Contact s technical support call to GenMark.  Any such on-site technical support will be provided between the hours of 8:00 a.m. to 5:00 p.m., Customer s local time, on a business day. After repair, the contractor shall submit a detailed work report to include all required materials and is to be at no-charge to the facility. 4.3. For the delivery of repairs parts or materials the contractor shall provide all parts and materials at no additional cost the government. 4.3.1 Contractor shall remove all parts, equipment or materials replaced, or upgraded by the contractor due to and not limited to repairs, replacements, recall, and upgrades without any cost to the government. 4.4 Training: The contractor will provide one annual off-site operator training for the Base year and subsequent Option years. 4.5 Safety 4.5.1 Contractor shall immediately notify the service of any changes in reagents kits composition, procedure modification, recall notification or any changes that will affect the performance of the test or procedure according to FDA regulations. 4.6 Test Performance 4.6.1 All test, procedures, and equipment must perform at manufacturer specifications; deviations from the performance specifications shall be corrected by the contractor. 4.6.3. All test performance will be evaluated by and not limited for performance thru peer comparison, quality control and CAP peer evaluation. Period of Performance Cost per Test Purchase Agreement for the Analyzer will be in effect for a contract year, with options to extend contract for and four (4) additional one (1) year periods. Base period - October 1, 2018 through September 30, 2019 Option 1 - October 1, 2019 through September 30, 2020 Option 2 - October 1, 2020 through September 30, 2021 Option 3 - October 1, 2021 through September 30, 2022 Option 4 - October 1, 2022 through September 30, 2023 Deliverables/Supplies 6.1 This procurement is for the lease of the Analyzer, and the purchase of reagents and supplies under the terms of the reagent rental agreement. 6.2 The contractor shall deliver all supplies necessary for test performance at no Government cost. 6.2.1 The contractor shall deliver all and not limited to operational, maintenance, troubleshooting, small repairs, equipment specifications and test manuals. 6.3 The contractor shall install the equipment and perform test verification according to manufacturer specification and CAP requirements. 6.4 The contractor shall provide equipment: kits for the Hepatitis C, Hepatitis B, and HIV Load assays. 6.4.1 In the event that requested supplies are on back-order, contractor is to provide information as to the estimated time of availability. 6.5 The contractor shall deliver all invoices for review according to the established contract at the end of each billing cycle. 6.5.1 All items not contracted shall be specifically detailed on the invoice including description, quantity acquired, and government cost. 6.6 Remedies: 6.6.1 Any changes in reagents or equipment modifications shall be immediately disclosed by the contractor electronically as well as by postal mail with supporting documentation of the change and, detailed guidance against implementation within twenty four hours of its application. 6.6.2 Additional charges incurred by the government to provide the continuity of contracted tests to patients and not limited to out sourcing, transportation and or any other additional cost shall be covered by the contractor at no additional charge to the government. Salient Characters A molecular system that has achieved moderate complexity categorization, and can sample from the primary tube. Regents and samples require no preparation and are ready to use. The system maintains a HEPA filtered clean room environment, separate reagent and sample pipetting systems to maintain result integrity, and head seals amplification wells to prevent system and specimen contamination. The system allows for flexible continuous sample loading and accepts a variety of primary tubes, eliminating batch testing. The system contains on-board refrigeration for long-term storage and stability, reducing reagent waste for low-volume assays. Samples are transferred by the system rather than the technologist. The system requires once-weekly maintenance of less than 60 minutes; no daily maintenance is required. Reagents and consumables are placed and tracked-on board and the system can be interfaced to eliminate manual entry of results.   Manual preparation of racks, cassettes and other consumable is not needed. Controls are included in the reagent kits. Throughput for first test result is 3 hours with 96 test results per 90 minutes or 384 results per 8-hour shift. Samples directly from the primary tube, is fully integrated for contamination prevention, and tracks consumables and reagents with minimal technologist interaction. System allows for future menu expansion of assays. The system requires once-weekly maintenance of less than 60 minutes; no daily maintenance is required. Manual preparation of racks, cassettes and other consumable is not needed. On-site technical support is available for escalations within 48 hours. Pathology & Laboratory Medicine Service (P&LMS) at the Dallas VA North Texas Health Care System (VANTHCS) will order reagents and supplies from the provider as needed to perform HIV and HCV PCR testing on the analyzer, which will be located in the P&LMS, Dallas VANTHCS. Contractor Security Contract Requirements. This contractor requires no access to VANTHCS or any VA information system. The Analyzer will be interfaced to the VANTHCS information system. There will be supervised access when the contractor is physically present for technical support, service calls, and scheduled preventative maintenance. NO VA DATA OF ANY TYPE SHALL BE TRANSFERRED FROM THE VA. Records Management All records (administrative and program specific) created during the period of the contract belong to VA North Texas Health Care System (VANTHCS) and must be returned to VANTHCS at the end of the contract. Quality Assurance Surveillance Plan (QASP) and its performance are as follows: Scoring Average score value per category: Exceptional 4 Very Good 3 Satisfactory 2 Marginal 1 Unsatisfactory <1 Standard Task ID (CPARS) Indicator Acceptable Quality Level Method of Surveillance Incentive Repeat runs are minimal due to reagent or instrument issues. 1.1 Successful reporting of results No more than 2 instances of repeat runs due to a single reagent or instrument issue per quarter. Exceptional: 0 Very Good: 1 Satisfactory: 2 Marginal: 3 Unsatisfactory: >3 Troubleshooting records Service records Exercise of Option Period Minimal unsuccessful performance due to instrument or reagent issues. 1.2 Successful peer group comparison 90% satisfactory performance to peer group. Exceptional: 100% Very Good: 95-99% Satisfactory: 90-94% Marginal: 85-89% Unsatisfactory: <85% CAP survey reports Exercise of Option Period Instrument downtime is minimal. 1.3 Instrument Repairs 90% satisfactory instrument performance annually. Exceptional: 100% Very Good: 95-99% Satisfactory: 90-94% Marginal: 85-89% Unsatisfactory: <85% Troubleshooting records Service Records Sendout records TAT reports Engineer visit within 48 hours of service designation. Schedules 2.1 Emergency Repairs 90% Visits within 48 hours of service designation. Exceptional: 100% Very Good: 95-99% Satisfactory: 90-94% Marginal: 85-89% Unsatisfactory: <85% Troubleshooting records Service records Exercise of Option Period Vendor initiates scheduling of preventive maintenance. 2.2 Proactive Maintenance Service 95% Visits initiated by vendor. Exceptional: 100% Very Good: 98-99% Satisfactory: 95-97% Marginal: 85-89% Unsatisfactory: <85% Service records Problem records Telephone Support is responsive. 2.3 Trouble-shooting via phone 95% Issues resolved within 3 calls or elevated to service. Exceptional: 100% Very Good: 98-99% Satisfactory: 95-97% Marginal: 85-89% Unsatisfactory: <85% Troubleshooting records Problem records Service records Exercise of Option Period Invoices are submitted monthly. Cost Control 3.1 Invoice Accountability 100% Invoices received through OLCS via Austin, Texas Invoice records Exercise of Option Period Invoices are itemized by service or product received. 3.2 Invoice Verification 80% Invoices contain all necessary information for proper processing. Excellent: 95-100% Very Good: 90-94% Satisfactory: 85-89% Marginal: 80-84% Unsatisfactory: <80% Invoice records Exercise of Option Period Backordered reagents and supplies are minimal. Management 4.1 Backorders <5% Backorders per year. Excellent: 0% Very Good: 1-2% Satisfactory: 3-4% Marginal: 5% Unsatisfactory: >5% Order records Invoice records Customer communications Exercise of Option Period Provides timely follow-up for backorders. Regulatory 6.1 Backorder Notification 90% timely follow up for backorders Exceptional: 100% Very Good: 95-99% Satisfactory: 90-94% Marginal: 85-89% Unsatisfactory: <85% Order records Invoice records Customer communications Exercise of Option Period Contractor will provide proactive notification of changes. 6.2 Notification of changes in reagent and equipment modifications 100% Proactive notifications. Quality Bulletins Customer Letters Customer Contact Exercise of Option Period Timely recall notification of reagent and supplies. 6.3 Recall Notification 100% Recall notifications within 1 month of issuance. Quality Bulletins Customer Letters Customer Contact Exercise of Option Period Works with customer to resolve complaints. Customer Satisfaction 7.1 Substantiated complaints No unresolved substantiated customer complaints per year Order records Invoice records Customer communications Problem records Troubleshooting records Exercise of Option Period Timely follow-up on complaints. 7.2 Complaint Handling 90% Complaint follow-up within 24 hours of initial complaint or within agreed upon timeframe. Exceptional: 100% Very Good: 95-99% Satisfactory: 90-94% Marginal: 85-89% Unsatisfactory: <85% Order records Invoice records Customer communications Problem records Troubleshooting records Exercise of Option Period 11. CHANGES TO STATEMENT OF WORK Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor. 12. CONFIDENTIALITY AND NONDISCLOSURE It is agreed that: 1. The preliminary and final deliverables, and all associated working papers, application source code, and other material deemed relevant by VA which have been generated by the contractor in the performance of this task order, are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the task order. 2. The CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order, presented to the contractor, shall be submitted to the CO for response. 3. Press releases, marketing material, or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO. The C&A requirements do not apply, a Security Accreditation Package is not required.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/VANTHCS/VANTHCS/36C25718Q9080/listing.html)
 

Document(s)

Attachment
 

File Name: 36C25718Q9080 36C25718Q9080.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4547815&FileName=36C25718Q9080-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4547815&FileName=36C25718Q9080-000.docx

 

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

Record

SN05040062-W 20180818/180816231046-0dd9cb3f9b87e6c8374375a94071def8 (fbodaily.com)
 

Source

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

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