This is a SOURCES SOUGHT announcement only. It is neither a solicitation announcement nor a request for proposal or quote and does not obligate the Government to award a contract. Responses to this Sources Sought must be in writing. The purpose of this Sources Sought Announcement is for market research, to make appropriate acquisition decisions, and to gain knowledge of potential qualified businesses capable of providing the following:
– Blood Gas Testing, Cost Per Test to include reagents and equipment
*** See Statement of Work below for details ***
If this is within your capability, please respond by 08/21/2020 at 11:00am CST with the information below:
Point of Contact
Phone, Fax, and Email
Vendor must be AUTHORIZED to service Siemens System and provide the required certification as applicable to this requirement. Interested firms are reminded that in accordance with FAR 4.12, prospective contractors shall complete electronic annual representations and certifications to be considered for award. In addition, FAR 4.11 states that prospective contractors shall be registered in the System for Award Management (www.SAM.gov) database prior to award of a contract. All Service Disabled Veteran Owned Small Businesses (SDVOSB) and Veteran Owned Small Businesses (VOSB) shall be verified in VetBiz at www.vip.vetbiz.gov.
Point of Contact for this Sources Sought is:
(913) 946 – 1981
Department of Veterans Affairs
Network Contracting Office -15
3450 S. 4th Street Trafficway
Leavenworth, KS. 66048.Ã‚Â
STATEMENT OF WORK
INTENT: It is the intent of the Department of Veterans Affairs, (herein afterwards referred to as VISN 15) to establish an agreement for Automated Blood Gas Instrumentation. The agreement shall be under open market Cost Per Reportable (CPRR). The Government will award a CPRR to a single Contractor for Automated Blood Gas Instrumentation, reagents, data management, and service. Contractor agrees to the following terms of the agreement exclusively with the VISN 15 and awarded in the final agreement. However, as requirements change, facilities within VISN 15 may be added or deleted by supplemental agreement of the Government and the Contractor. Additional tests/reagents/instrumentation may be added to the award as new technology becomes available on the market.
ORDERS: This agreement does not obligate any funds. The Government is obligated only to the extent of authorized orders issued under the agreement by authorized individuals.
PRICES AND TERMS: VISN 15 will provide an estimated volume by test as reflected in Attachment A for each individual medical center and outpatient clinic laboratory. Pricing is based on the AVERAGE daily test volume per instrument/analyzer for each facility. The Government estimates the volumes per facility as listed in Attachment A but does not guarantee volumes as listed; they are estimates ONLY. CPRR price will include all components (reagent, equipment, data manager system, hardware, software, service, etc.) necessary to allow for release of a test result into the VISTA computer system.
TERM OF AGREEMENT: This will be a single award, firm-fixed price agreement with one base year and four one-year options. VISN 15 intends to establish the base year of the agreement for the period of 1/1/2021 through 12/31/2021.
ORDERING METHOD: The participating facilities may order products via Electronic Data Interchange (EDI), telephone, facsimile or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions.
DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK
SCOPE OF PROCUREMENT:
The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the statement of work. The instrument shall have capability to perform testing as described below and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).
Equipment shall be acquired for each of the clinical laboratories located at the VISN facilities.
Preferred analyzer(s) shall be able to simultaneously perform the complete panel as defined by each facility.
If Contractor offers a family of analyzers, VISN 15 technical evaluation panel will determine if instrumentation proposed meets needs of each participating facility.
The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables and any other materials required to properly perform tests on the equipment, such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Expiration date must be clearly marked on reagent, standards and control containers. Unexpected changes in methodology or technology shall be at the expense of the Contractor. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals determined at contract award. Estimated volumes of testing can be found in Attachment A (will be provided in the solicitation).
Special handling for emergency orders of supplies: In the event that the supplies are 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 is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor s equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery.
Cost per Patient Reportable Result (CPRR): as defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers – Contractors are required to provide a price for a reportable patient result. The per patient reportable result price shall include costs covering: (1) 5 year equipment use; (2) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor s equipment and necessary for the generation of a patient reportable result. The per patient reportable result price shall also encompass all costs associated with repeat and confirmatory testing required to produce a single patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI); (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs); and (4) training for Government personnel. Contractors shall provide delivery, installation and removal of equipment at no additional charge.
Cost per Test (CPT)- as defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers Contractors are required to provide a price for each test that can be performed on its equipment. The per test price shall include costs covering (1) 5 year equipment use; (2) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor s equipment and necessary for the generation and reporting of a test result; (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs); and (4) training for Government personnel. Contractors are required to provide delivery, installation and removal of equipment at no additional charge.
Business Associate Agreement (BAA)- A business associate is an entity, including an individual, company, or organization that, on behalf of VHA, performs or assists in the performance of functions or activities involving the use or disclosure of PHI, or that provides certain services involving the disclosure of protected health information (PHI). VHA is a covered entity under the HIPAA Privacy Rule (Privacy Rule). HIPAA regulations require VHA to execute HIPAA-compliant BAAs with certain entities that receives, uses, or discloses VHA PHI in order to perform some activity for VHA. These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule.
Memorandum of Understanding (MOU) – The VA utilizes a MOU to document the terms and conditions for sharing data and information resources in a secure manner. The following supporting information within the MOU will define the purpose of the interconnection, identify relative authorities, specify the responsibilities of both organizations, and define the terms of the agreement. Additionally, the MOU provides details pertaining to apportionment of cost and timeline for terminating or reauthorizing the interconnection.
Interconnection Security Agreement (ISA) -Technical details on how the interconnection is established or maintained are included within the ISA. A system interconnection is a direct connection between two or more information technology (IT) systems for the purpose of sharing data and other information resources. The VA uses the ISA to formally document the reasons, methodology, and approvals for interconnecting IT systems; to identify the basic components of an interconnection; to identify methods and levels of interconnectivity; and to discuss potential security risks associated with the interconnections.
Data Input Definitions
Patient Identification Number
Patient Full Name
Patient Date of Birth
Allen s Test Performance
Laboratory Accession Number
Laboratory Accession Number
Each participating location will have varied assay requirements. Equipment offered shall provide all reportable assays listed in 22.214.171.124 and 126.96.36.199. Refer to Attachment A for desired test menu and estimated annual volumes specific to each location.
Equipment offered must, at minimum, be able to report the following measured assays:
Blood Gas Panel
Total Hemoglobin (measured)
Reduced Hemoglobin (HHb)
Hematocrit (preference is a measured hematocrit, however instruments only offering calculated hematocrit will be evaluated)
Hemoglobin (preference is a measured hemoglobin, however, as need for Co-oximetry is site-specific instruments only offering calculated hemoglobin will be evaluated)
Equipment offered must, at minimum, be able to report the following calculated assays:
Percent Oxygen Saturation (sO2)
Primary Analyzer(s): Base equipment offered shall fully support the scope of operations. Depending upon the technical functionality and the capabilities of the individual manufacturer s instrumentation, two mirror-image analyzers to act equally as primary analyzers are required to meet the productivity specifications defined herein.
FDA Approval: The instrumentation must be approved by the Food and Drug Administration (FDA) as a waived or moderately complex analyzer
Hardware & Software: The instrumentation shall have the following:
A benchtop or portable analyzer with a total equipment footprint that when installed shall not impact the functionality/operations of that laboratory.
Equipment shall not exceedÃ‚Â Ã‚Â Ã‚Â Ã‚Â Ã‚Â Ã‚Â Ã‚Â Ã‚Â Ã‚Â Ã‚Â
Ã‚Â Ã‚Â Ã‚Â Ã‚Â Ã‚Â Ã‚Â Ã‚Â Ã‚Â Ã‚Â Ã‚Â Ã‚Â (W in X H in X D in)
36 (current tables are 3 ft wide)
An on-board monitor/screen that is easily readable.
A printer that has the capability of printing a patient report with patient demographic information that includes minimally the patient s name, accession number or unique identifier number (UID), date and time of test.
An uninterruptible power supply (UPS) for each instrument provided, including replacement of batteries.
Vendor shall include all hardware, including servers, and software for necessary for required data management.
In most cases, two servers would be required (one each for Eastern and Western Orbit)
All devices running windows must be Windows 10 OS at the time of award.
A bi-directional computer interface compatible with the current VA laboratory information system (VISTA). The fully operational interface (both hardware and software) shall be immediately available for interfacing to the VA computerized hospital information system.
Vendor must be able to interface results through current Data Innovations Instrument Manager
All equipment and software required for the interface must be provided
Remote monitoring and data management
Remote monitoring capabilities to include instrument monitoring (and appropriate notification to site of errors/warnings related to analyzer functions) and quality control management.
Remote monitoring software must have National ISA/MOU approval with documentation for specific analyzer(s) being proposed.
Remote monitoring must be currently in use by other VA facilities.
Vendor must supply the following documentation for all analyzers and data management systems proposed to VISN 15:
MDS2 – Manufacturer Disclosure Statement for Medical Device Security.
VA Directive 6550 Appendix A- Pre-Procurement Assessment
FIPS-140-2 Certification if analyzer will use Wireless technology
MOU/ISA for Data Management systems that will require vendor access
Capability of performing 100% of the tests defined by each location in attachment A on one analyzer
Arterial, venous, mixed venous, and body fluid sample options
Sample delivery into instrument from syringe and vacutainer tubes
Enough capacity and throughput to meet the volume and service demands as defined in Attachment A
Data entry and storage of operator and patient information as defined in sections 188.8.131.52 and 184.108.40.206
Safety features to avoid unnecessary exposure to biohazardous and chemical material. The exposure to and the volume of biohazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling
Barcode scanner for entry of patient, operator, and reagent information. Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently.
Expired operator, failed quality control and invalid lot number instrument lock out
Daily, weekly, monthly, and periodic maintenance shall be minimal and easily documented in analyzer/data management system. Contractor shall supply documentation detailing maintenance requirements.
Ability to store, retrieve and retransmit test records in case of interface outage.
On board reagent inventory system.
Analyzer shall utilize self-contained reagents and closed reagent containers
Reagents capable of room temperature storage are preferred
On-board reagent stability that accommodates both high and low volume use, with minimal waste.
Reagent and control lot numbers shall be sequestered for each participating facility as requested for use of one lot number for, at minimum, a six-month period.
Expiration date must be clearly marked on reagent, standards and control containers.
Error detection and prevention, including but not limited to:
Detects clots and/or prevent clots from entering the instrument.
Ensures proper specimen mixing
Detects and prevents errors related to bubbles
Detects when interferences are present
Calibrators for pH, CO2 and O2 sensors should be traceable to NIST Standard Reference Materials.
Analyzer must allow for scheduled performance of 1-point, 2-point, and system calibrations, without operator intervention.
If analyzer requires a gas calibrator, the cylinder should be vendor-validated prior to shipment.
Gas calibrator cylinder should be easily disposed of and not result in a disposal fee.
Lower pressure cylinder is preferred over a high-pressure cylinder.
Assayed quality control and linearity solutions will be provided.
Analyzer must have the ability to lock out operators from patient testing if quality control fails.
On-board Quality Control data management system that includes Levy-Jennings graphs. Analyzer must have the ability to capture, store and electronically transfer QC data.
Capability to detect out of range quality control and omit outliers as needed to reflect accurate quality control statistics. Omission of outliers is preferred over deletion of outliers.
Analyzer must have the ability to document review of quality controls and corrective actions performed.
Analyzer must have the ability to schedule and perform internal or electronic automatic Quality Controls.
Preferably, quality controls should be processed using the same pathway as patient samples.
Preferably, automated QC processes will allow for parallel testing of old and new lot of QC material.
Maintenance requirements should be low with limited hands on maintenance
Analyzer should have the ability to document maintenance on board.
Maintenance associated with electrode changes should result in minimal down time.
Waste must be self-contained and be easily disposed of.
If analyzer is portable, the vendor must supply documentation that movement of the analyzer on a regular basis will not require that the analyzer be re-validated with each move.
Analyzer should have onboard operating manual and troubleshooting guides.
Method Performance/Validation Requirements
Method performance/comparison shall be at the expense of the Contractor, shall include linearity material and reagents, and be consistent with current CLSI guidelines and related documents, College of American Pathologists (CAP) standards and Federal regulations.
Correlation studies for each analyte. A minimum of 20 samples spanning the reportable range, shall be run by the present and the proposed method. In systems where multiple sampling modes exist, mode to mode correlation studies must also be performed. Contractor shall analyze results and provide statistical data to support acceptance of the new method for above studies. Statistics shall consist of at least mean, bias, slope, y-intercept, correlation coefficient, ROC analysis, and meet current standards defined by CLSI.
Analytical Measurement Range (AMR) Validation shall be performed on proposed instrument(s) for each analyte to validate the reportable range. The material must have values, which are near the low, mid, and high values of the AMR and be of appropriate matrix for the clinical specimens assayed by that method. A minimum 5-point linearity analysis that adheres to the Beer-Lambert Law and spans the entire range shall be performed as a minimum.
Precision study using normal and abnormal control material. This shall consist of a within run precision study of 10 normal and 10 abnormal controls and a day-to-day precision study of normal controls and abnormal controls for 10 days (may be run twice a day) for a total of 20 values per level of control. Intra-VISN facility variations should be kept at an absolute minimum.
Sensitivity. Sensitivity may be validated concurrently with correlation studies. Mathematical calculations to determine efficiency, sensitivity, false positive rate and false negative rate are applied.
Specificity Studies. A review of product literature and assay inserts to determine any adverse effects for increased bilirubin, hemolysis, lipemia, or other interfering substances.
A reference range must be determined for each test following CLSI guidelines. Samples used for the reference range study must be representative of the patient population being tested. Reference range assessment must be performed for each lab. One of the following protocols shall be used:
A verification of the manufacturer s suggested reference range may be performed if the suggested range is based on a comparable population of test subjects. The manufacturer shall provide specific information defining how the suggested range was determined. A minimum of 20 reference individuals shall be used at each VISN 15 location to verify the manufacturer s range. Any apparent outliers should be omitted, and new specimens obtained to provide a statistically valid verification.
If the suggested manufacturer s range is not appropriate for the patient population, a reference range shall be established. Establishing a reference must follow CLSI guidelines. This requires a minimum of 120 reference individuals to be used to establish a reference range. The reference interval should be determined using the nonparametric method.
If a laboratory is currently using the proposed instrument/reagent system, the in-use reference range can be transferred to the new system if a method comparison study between the two systems proves to be acceptable. If comparison studies are not acceptable, one of the two above items must be performed.
Carryover Studies. Successful carryover studies shall be completed by the contractor on all analyzers during installation. These studies shall be performed using either contractor developed program(s) or program(s) developed by a third party (CAP/CLSI). The programs shall be provided to each laboratory at no charge.
Internal Barometer Check. If the instrument has an internal barometer, its function should be checked by comparing its values to a reliable independent measurement on installation and per the manufacturer s guideline. This check should be performed by the vendor.
Reports: The Contractor shall provide to the Contracting Officer and other individuals (designated post-award) a copy of a quarterly report of sales, by ordering facility, within 30 calendar days after the close of each quarter s business. Reports are to reflect, at a minimum, total net sales amounts before discount, and discount amounts by ordering facility as well as the raw data used to develop these reports. These reports shall be used to monitor the commitment of each facility, reporting the savings realized and shall be shared with each participating facility, personnel associated with acquiring the products, and respective laboratory personnel. Additional invoice charges associated with reagent and/or supply wastage or repair parts included at no charge (per FSS awarded contract) shall not be accepted. There will be no additional charges for any reports required as part of the agreement. Attachment C may be used as a template to provide these quarterly reports.
Commercial marketing. The equipment models being offered shall be in current production as of the date this offer is submitted. For purposes of this solicitation, current production shall mean that the clinical laboratory analyzer model is being offered as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable.
Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other item required to establish instruments for operation for performance of acceptance testing. The Contractor shall perform, to the satisfaction of the Government, all validation studies as stated in the Method Performance/Validation section above and report data in an organized, clearly comprehensible format at no cost to the Government.
Training. The Contractor shall provide instrument training program that is coordinated with and timely to the equipment installation and appropriate for the size and scope of the facility s services. This shall include detailed, hand-on training on the operation of the system, data management, maintenance, quality control, limitations of tests, data manipulation, and basic troubleshooting and repair. When training occurs on-site, all operators performing testing will be trained by the contractor. When such training occurs off-site, it will include two operators per analyzer in the first year. Thereafter, the Contractor shall provide off-site training for minimally one operator per facility per year at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant. There shall be no difference in the detail of training provided on-site and off-site.
Equipment Preventative Maintenance/Repair Service. The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all primary instrumentation and any incremental support equipment, e.g. water system, offered according to the following terms:
A technical assistance center shall be available by telephone 24 hours per day, 7 days per week with a maximum call back response time of 1 hour.
Equipment repair service shall be provided during core business hours. See Attachment A defining core business hours of each facility included in this solicitation. 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, and
proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.
220.127.116.11.1.6 Each notification for an emergency repair service call shall be treated as a separate and new service call.
Upgrades – The Contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and the state-of the-art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to system upgrades that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. this does not refer to replacing the original piece of equipment provided under the agreement; however, it does refer to significant changes in the hardware operational capability.
ancillary support equipment – the contractor shall provide, install and maintain through the life of the agreement , as indicated, any and all ancillary support equipment to fully operate or place the analyzer within a laboratory as defined in these specifications, e.g. carts or stands to support/house the analyzer, water systems (including consumable polishers, filters, etc.), and universal interface equipment, etc. In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, tables/stands, line conditioners, UPS and UPS Batteries etc.
Waste Stream Specifications
Characterization of waste The Contractor shall provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges in accordance with the requirements of the Code of Federal Regulations Title 40 Protection of the Environment Part 261 et seq. and applicable state and local requirements. Documentation shall include a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations, Safety Data Sheets (SDS) meeting the requirements of the Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA), the analytical process used to determine the hazardous nature and characteristics of the waste, and the analytical test results. Testing of hazardous waste is to be done in accordance with testing protocol specified for each individual waste as described in the Code of Federal Regulations Title 40 to make a determination if the waste is a hazardous waste or otherwise regulated.
The determination and description shall address the following:
Waste toxicity (Reference 40 CFR Ã‚Â§261.11 and 40 CFR Ã‚Â§261.24)
Waste ignitability (Reference 40 CFR Ã‚Â§261.21)
Waste corrosivity (Reference 40 CFR Ã‚Â§261.22)
Waste reactivity (Reference 40 CFR Ã‚Â§261.23)
Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR Ã‚Â§261.31)
Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40 CFR Ã‚Â§261.33)
Solid Waste (Reference 40 CFR Ã‚Â§261.2)
Exclusions (Reference 40 CFR Ã‚Â§261.4)
The contractor will provide written instructions and training material to ensure VHA laboratory staff are trained as needed to properly operate devices with special emphasis to managing and disposing of hazardous waste in accordance with EPA and state requirements. Additionally, the training provided by the contractor must fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices.
Contractor shall provide a description of all wastes the process or equipment may discharge so that the facility can determine whether the discharge meets Local Publicly Owned Treatment Works (POTW), State and Federal discharge requirements. At a minimum the characteristics of ignitability, corrosivity, reactivity and toxicity as defined in 40 CFR Ã‚Â§261 must be determined and documented. Any mercury containing reagents must be identified in any concentrations. All test results shall be provided. All listed chemicals (F, U, K and P) found in 40 CFR Ã‚Â§261 shall be provided in product information and their concentrations documented. For those materials with a positive hazardous waste determination, a mechanism for the laboratory to meet local discharge requirements (i.e. mercury, thimerosol and formaldehyde) must be developed and SDS sheets must be provided in advance for review. At a minimum, documentation shall include, but not be limited to the concentration/measures of the elements and parameters listed below and must be included with vendor response:
Flash point (to higher than 200F)
BOD; biochemical oxygen demand
The documentation the contractor provides will be used to work with the VAMC and the public and/or private organization (e.g., POTW) to determine whether the waste from each device can legally be disposed of via the sewerage system
Implementation/transition timeframe – The implementation of the services/requirements described in this solicitation shall be completed no later than 90 days after the award of the agreement. this timeline is based on a reasonable attempt of the contractor to complete all the necessary implementation requirements within the stated timeframe. contractor shall not be penalized for implementation timelines that extend beyond the 90-day timeframe, if the extension is through no fault of the contractor and is a result of delays due to the government.
Upon award of an agreement, the transition period for the awarded agreement to have all equipment and peripherals installed and operational by January 1, 2021. during this same period, all initial training of VA personnel in the operation and maintenance of said award shall also be completed.
Contractor shall provide with its quotation an implementation plan for installation of new equipment. contractor s submitted plan shall project for the transition of all services under the awarded agreement including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations with a start date of January 1, 2021. Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate agreement for cause under the Termination for Cause clause of the agreement.
On January 1, 2021, the awarded Contractor shall have full and sole responsibility for services under the awarded agreement.