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FBO DAILY - FEDBIZOPPS ISSUE OF MARCH 22, 2018 FBO #5963
DOCUMENT

66 -- NTX Inova Diagnostics - Attachment

Notice Date

3/20/2018
 

Notice Type

Attachment
 

NAICS

334516 — Analytical Laboratory Instrument Manufacturing
 

Contracting Office

00504;Department of Veterans Affairs;Contracting Section;7201 I-40 West Suite 100;Amarillo TX 79106
 

ZIP Code

79106
 

Solicitation Number

36C25718Q0590
 

Archive Date

5/19/2018
 

Point of Contact

Lula Hill
 

Small Business Set-Aside

N/A
 

Description

The North Texas VA Health Care System (NTVAHCS) is seeking Service Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB) or Small Business (SB) sources capable of meeting the requirement listed below. The acquisition will be accomplished using commercial item procedures in accordance with FAR Part 13. NOTE: TO QUALIFY SDVOSB AND VOSB VENDORS MUST BE CERTIFIED IN THE VA VENDOR INFORMATION PAGES (VIP) DATABASE. The North American Industry Classification System (NAICS) are 334516. Any SDVOSB, VOSB or SB firms who wish to identify their interests and capability to provide this service must notify the Contract Specialist no later than NOON PM Central Time, March 28, 2018. Notification shall be e-mailed to Lula Hill, at lula.hill3@va.gov. Provide Cage Code and or DUNS number. DISCLAIMER This Source Sought Notice is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this Notice that is marked as proprietary will be handled accordingly. In accordance with the Federal Acquisition Regulation, responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this Notice. SCOPE: STATEMENT OF WORK GENERAL INFORMATION DESCRIPTION: Reagent Rental Purchase Agreement for the INOVA Diagnostics QUANTA Link, NOVA View, and QUANTA-Lyser 3000 System with Laboratory Reagents and Supplies for Immunology EIA and IFATesting 1.0 Purpose Requesting the procurement of INOVA Diagnostics QUANTA Link, NOVA View, and QUANTA-Lyser 3000 System through a cost per test agreement. 2.0 Scope Vendor will provide INOVA Diagnostics QUANTA Link, NOVA View, and QUANTA-Lyser 3000 System with designated ancillary equipment including printer, computer, software, and accessories; training, technical support, and business hours service plan for all equipment. The test menu includes: ANA-IFA, Mitochondrial (M2 EP (MIT3), ANCA IFA (ETOH and Formalin), Crithidia IFA, ENA EIA Screen, Jo-1, RNP, Scl-70, Sm ELISA, SS-A, SS-B, LKM-1, Actin IgG, H. pylori IgG, TrepSure IgG/IgM, Measles IgG, Mumps IgG, Rubella IgG, VZV IgG, Herpes 1 IgG, and Herpes 2 IgG. Pathology & Laboratory Medicine Service (P&LMS) at the Dallas VA will order reagents and supplies from Inova as needed to perform testing on the analyzers. 3.0 Location The Inova Diagnostics system will be located and testing will be performed in the CSI/ Immunopathology Section of Pathology & Laboratory Medicine Service, VA North Texas Health Care System (VANTHS), 4500 S. Lancaster Rd, Dallas, TX 75216. 4.0 Performance Maintenance includes the following: 4.1.1 Inventory and recording of systems components. 4.1.2 Monthly deliverables shall be ordered as arranged between vendor and P&LMS and received in full. 4.1.3 Testing all components for proper test performance. Equipment shall reproduce results according to manufacturer s specifications. 4.2. Repairs and Support. 4.2.1 Technical Support: Support Personnel will be available by telephone 0630 to 1600 PST Monday through Friday, excluding US national holidays.  Technical support will be conducted by telephone or on-site with service engineer only. 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, contractor will dispatch one or more Service Personnel to such facility, normally within 24-48 business hours after the complaint has been logged by Customer Support. 4.2.2.2 Preventative Maintenance: Vendor shall initiate scheduling for and provide two (2) preventive maintenance visits per plan year for the Quanta-Lyser 3000 and one (1) preventive maintenance visit per plan year for the Nova View Fluorescence Microscope. 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 initial on-site operator training and yearly subsequent training for the system. 4.4.1 Validations: The contractor will provide initial installation and validation support of the new system and any new assays. 4.5 Safety 4.5.1 Contractor shall immediately notify the service of any changes in reagent 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 tests, 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. 5.0 Period of Performance Cost per Test Purchase Agreement for the INOVA Diagnostics QUANTA Link, NOVA View, and QUANTA-Lyser 3000 System will be specified in the contract. Contractor shall provide option to upgrade to newer version of instrument, if available, in option years. Instrument must be able to test the following assays: LKM-1 Mitochondrial AB(MIT3) EIA Actin IgG EIA HSV 1&2 IgG AB EIA ENA Screen 6 EIA Treponemal AB IgG and IgM EIA Measles IgG EIA Mumps IgG EIA Rubella IgG EIA VZV IgG EIA H. pylori IgG EIA ANA IFA SSA EIA SSB EIA Sm EIA RNP EIA Jo-1 EIA DsDNA EIA Scl-70 EIA ANCA IFA (ETOH and Formalin) 6.0 Deliverables/Supplies This order is for the cost per test procurement of the INOVA Diagnostics QUANTA Link, NOVA View, and QUANTA-Lyser 3000 System. Reagents and supplies will be purchased under the terms of the reagent rental purchase agreement. 6.1 The contractor shall provide initial on-site customer training and subsequent yearly training to meet the objectives identified in paragraph 4. In addition, the contractor shall provide handouts and training materials in sufficient quantity for each participant. These are off-the-shelf courses. The contractor shall provide lesson plan, course materials and media (DVD s, CD s, videos, etc. if required), and editable procedures at no additional cost. 6.2 The contractor shall deliver all equipment necessary for test performance at no additional cost. The government will not pay for freight, shipping, or delivery fees for equipment, reagents, and consumables for the length of the contract. 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. 6.4.1 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. System Requirements 7.1 Instrument must consist of the following to meet the needs of the customer: Inova is the supplier of FDA-approved ANCA and Crithidia (dsDNA) IFA technology and the NOVA View is the only FDA-approved instrument with single well titer for IFA testing. The NOVA View generates pattern identification using an approved algorithm and does not require algorithms based on customer input. The QUANTA-Lyser 3000 is the only instrument that allows both EIA testing and IFA processing in tandem at the required test volumes. Does not use the following software: Windows XP Embedded Service Pack 3, Windows Server 2003 or Windows XP 8.0 Contractor Security Contract Requirements. The INOVA Diagnostics QUANTA Link, NOVA View, and QUANTA-Lyser 3000 System has the capability for remote access for service related issues, with no access to PHI, and the vendor must follow the terms of the agreement outlined in the VA National site-to-site agreement. The instrument will be interfaced through Data Innovations 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. The instrument hard drive will remain on site for external repairs or termination of the lease. NO VA DATA OF ANY TYPE SHALL BE TRANSFERRED FROM THE VA. 9. 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 NARA RM Language Clause 1. Citations to pertinent laws, codes and regulations such as 44 U.S.C Chapter 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. 2. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. 3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. 4. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act. 5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract or identified in the RCS 10-1. 6. The Government Agency owns the rights to all data/records produced as part of this contract. 7. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data. 8. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.]. 9. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules. 10. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under or relating to this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/VAAHCS/VAAHCS/36C25718Q0590/listing.html)
 

Document(s)

Attachment
 

File Name: 36C25718Q0590 36C25718Q0590.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4164771&FileName=36C25718Q0590-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4164771&FileName=36C25718Q0590-000.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: Department of Veterans Affairs;VA North Texas Health Care System;4500 S. Lancaster Rd;Dallas, Texas

Zip Code: 75216
 

Record

SN04860442-W 20180322/180320231118-2b56e10ba726ae84a2d86304fbedd28e (fbodaily.com)
 

Source

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

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