Electrophoresis Analyzer

Added: Jun 08, 2018 5:00 pm The Amarillo VA Health Care System (AVAHCS), on behalf of the Central Texas VA Health Care System in Temple, Texas is seeking Service Disabled Veteran Owned Small Business (SDVOSB) or Veteran Owned Small Business (VOSB) sources capable of meeting the requirement listed below. The acquisition will be accomplished using commercial item procedures in accordance with FAR Part 12.



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) is 325413. Any SDVOSB or VOSB firms who wish to identify their interests and capability to provide this product must provide product specifications, performance and delivery information by notifying the Contract Specialist no later than NOON PM Central Time, June 18, 2018. Notification shall be e-mailed to Robyn Nussbaum, at robyn.nussbaum@va.gov.



Any vendor who responds to this Notice must provide credentials to provide electrophoresis instruments as detailed below.



DISCLAIMER



This Sources 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



GENERAL INFORMATION



1. Title of Project: Semi-Automated Gel Electrophoresis

2. Purpose: Requesting the procurement a Semi-Automated Gel Electrophoresis through a Reagent Rental agreement.

3. Scope of Work: The contractor shall provide a semi-automated, gel electrophoresis instrument that can perform both serum and urine electrophoresis (SPEP/UPEP), and immunofixation (SIFE/UIFE) to identify monoclonal and polyclonal gammopathies.





B. GENERAL REQUIREMENTS

All written deliverables shall be phrased in layperson language. Statistical and other technical terminology shall not be used without providing a glossary of terms.

C. TASKS, DELIVERABLES/SUPPLIES

The contractor shall provide a semi-automated, gel electrophoresis instruments capable of performing both serum and urine electrophoresis (SPEP/UPEP), and immunofixation (SIFE/UIFE) to identify monoclonal and polyclonal gammopathies. The instruments shall meet all technical specifications stated in the statement of work. Contractor shall provide all necessary maintenance to keep the equipment in good operating condition (including both preventative maintenance and emergency repairs) and training for Government personnel. Contractor is also required to provide delivery, installation, bi-directional interfacing, method validation, and removal of equipment upon completion of agreement.



1. Analyzer Requirements:

Capillary electrophoresis

8 Capillary electrophoresis Bench top analyzer

Test menu: Protein 6, immunotyping

Continuous sample loading

Direct sampling from primary tube

Positive sample identification, full traceability from primary tube to final result

Barcoded reagents and controls

Gel electrophoresis

Semi-automated Gel electrophoresis bench top analyzer

Test menu: Immunofixation, Bence Jones

Sample types: Serum, urine

Must have options of 1, 2, or 4 tests/gel

Onboard densitometer scanner

Software

Networking connection of instruments

Multi-client configuration for different operators

Automatic flagging of abnormal values

Curve recall, review and editing

Pre-programmed comments or manual entry

Reference pattern overlay

Unlimited storage of patient database

Automatic patient history search

Color coded profiles

Bidirectional LIS connection



2. General Requirements:

Electrophoresis instruments shall produce accurate and reproducible assay results on serum or urine specimens for SPEP/UPEP and SIFE/UIFE electrophoresis by established in vitro diagnostic methods. Offered equipment shall be new state-of-the-art equipment. Remanufactured and discontinued models will not be accepted.

Upgrades to the equipment hardware and operating system software shall be provided at no additional cost to the Government. These enhancements shall be delivered and installed within 60 days of issuance to the commercial market.

An operator s manual shall be furnished with each instrument supplied and updates to manual shall be provided in a timely manner. Editable electronic copy in CLSI format of operating procedures shall be furnished with each instrument supplied to the VA.

Laboratory assays currently performed shall include, but may not be limited to the following automated assays.

Serum Protein Electrophoresis

Serum Immunofixation.

Urine Immunofixation.

Start-up Reagents and Supplies: The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other items required to establish instrument for operation and acceptance testing. The Contractor shall provide the Government with validation and method comparison studies. All materials and reagents needed for such correlation are at no cost to the Government. The Contractor shall perform all statistical analysis and report data in an organized, clearly comprehensible format. This process shall be completed within two weeks of installation of the analyzer and shall be consistent with current CLSI and related documents, CAP Standards and Federal Regulations.

All consumables, reagents, calibrators, controls, supplies, disposable items, parts, accessories and any other items required for the proper operation of the contractor s equipment and necessary for the generation and reporting of a patient test result shall be included if CPRR or RR.

Service Requirements: The Contractor shall be able to provide emergency equipment repair and preventative maintenance on the equipment.

A technical assistance center shall be available by telephone 8 hours per day, 5 days per week with a maximum call back response time of 4 hours.

Equipment repair service shall be provided during core business hours. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel.

Equipment repair response time shall be no more than 24 hours.

Preventative maintenance will be performed as frequently as published in manufacturer s operator s manual and within 2 weeks of the scheduled due date.

A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following:

date and time notified

date and time of arrival

serial number, type and model number of equipment

time spent for repair,

proof of repair that includes documentation of a sample run of quality control

verifying acceptable performance.

Each notification for an emergency repair service call shall be treated as a separate and new service call.

Flexibility in test volumes shall be considered.

Extended expiration date of supplies shall be provided.

Training for all testing personnel, and Key Operator training for a minimum of two operators is required.

Systems shall provide ease of use menus, with minimal maintenance required and simple troubleshooting processes.

3. Technical Requirements:

Equipment shall have a fully bi-directional, ASTM or HL7 Lab Information System (LIS) interfacing. All downloads/software necessary to transfer orders and data into patient files via LIS interface will be at no additional cost to VA.

Contractor shall provide at least one (1) each automated, auto-sampler instrument and (1) each automated electrophoresis/scanner instrument and peripherals

Electrophoresis separation system shall have barcode reading capabilities to assure Positive Patient ID.

Electrophoresis instrument shall be a bench top model to fit into the current laboratory configuration.

Data backup shall be provided.

Uninterruptible power supply (surge protection, battery backup) shall be provided and serviced by the vendor for all associated electrical instruments and ancillary components excluding printer.

Imaging system must provide permanent file retention of non-modified pattern image.

Schedule of Deliverables



Item No.

1

2

Item



Semi-Automated Gel electrophoresis instrument

Semi-Automated Immunofixation instrument



Quantity



1

1

Delivery Date



Within 60 calendar days after award

3

4

5

Reagents, Controls and consumables for SPEP testing

Reagents, Controls and consumables for SIFE testing

Reagents, Controls and consumables for UIFE testing



3120

1768

104

IDIQ

IDIQ

IDIQ



D. PERFORMANCE REQUIREMENTS

Maintenance: The contractor shall perform preventative maintenance at intervals specified by the manufacturer to ensure proper equipment performance. Maintenance includes the following:

Inventory and recording of systems components.

Monthly deliverables shall be received in full.

Testing all components for proper test performance. Equipment shall reproduce results according to manufacturer s specifications.

After Preventative Maintenance (PM), the contractor shall submit a detailed work report for notice at no additional cost to the government.

Delivery of PM parts or materials: the contractor shall provide all preventative service materials at no additional cost to the government.

Repairs and support

Technical support: Support Personnel will be available by telephone from 0800 to 1700 each business day.

On site repairs: Contractor will dispatch on-site support personnel within 24 business hours of determining that phone support is insufficient to correct problem. After repair, the contractor shall submit a detailed work report to include all required materials at no charge to the facility.

For the delivery of repair parts or materials, the contractor shall provide all parts and materials at no additional cost to the government.

Contractor shall remove all parts, equipment or materials replaced, or upgraded by the contractor due to, but not limited to, repairs, replacements, recall, and upgrades without any cost to the government.

Training: The contractor will provide training

Safety: Contractor shall immediately notify the service of any changes in reagents, kit composition, procedure modification, recall notification or any changes that will affect the performance of the test or procedure according to FDA regulation.

Test Performance: All tests, procedures, and equipment must perform at manufacturer specifications. Deviations from the performance specifications shall be corrected by the contractor.

All test performance will be evaluated by and not limited for performance thru peer comparison, quality control, and CAP peer evaluation.

Should consumables be found to be defective and unsuitable for use with the contractor'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 twenty-four hours after receipt of the verbal order for priority delivery from the Government activity.



E. 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.

F. CONTRACTOR SECURITY REQUIREMENTS

This contractor requires no access to CTVHCS or any VA information system. The analyzers will be interfaced to the CTVHCS information system. There will be supervised access when the contractor is physically present for technical support, service calls, and scheduled preventative maintenance.

The C&A requirement do not apply. A security accreditation package is not required.

NO VA DATA OF ANY TYPE SHALL BE TRANSFERRED FROM THE VA.

G. RECORDS MANAGEMENT

All records (administrative and program specific) created during the period of the contract belong to Central Texas Veterans Healthcare System (CTVHCS) and must be returned to CTVHCS at the end of the contract.

H. QUALITY ASSURANCE SURVELLIANCE PLAN (QASP)



The QASP and its performance are as follows:



Task

Indicator

Standard

Acceptable Quality Level

Surveillance

Method

Incentive

Safety

Recall Notification

Timely recall notification of reagent and supplies

100%

Monthly Monitoring

Exercise of Option Period & Past Performance

Quality Assurance

Preventative maintenance

PM performed within specified timeframe

95%

Direct Observation











Exercise of Option Period & Past Performance

Emergency Repair & phone support

Within 24 hours

95%

Monthly monitoring

Successful peer group comparison

CAP survey performance

95%

Direct Observation & CAP survey reports

Successful reporting of results

Repeat runs are minimal

95%

Direct Observation & QC reports

Customer Satisfaction



Satisfactory shipment and quality of consumables/reagents

Reagents received timely and free of defects

90%

Reports of contact or other documentation.

Exercise of Option Period & Past Performance