Inactive

STATEMENT OF WORK Clinical Laboratory Chemistry Immunochemistry Instrumentation INTENT INTENT: It is the intent of the Department of Veterans Affairs, (herein afterwards referred to as VISN4 Altoona, ... STATEMENT OF WORK Clinical Laboratory Chemistry Immunochemistry Instrumentation INTENT INTENT: It is the intent of the Department of Veterans Affairs, (herein afterwards referred to as VISN4 Altoona, Butler, Coatesville, Erie, Lebanon, Pittsburgh, and Wilmington laboratories) to acquire Automated Chemistry and Immunochemistry Instrumentation. TERM OF CONTRACT: This is a five (5) year, firm-fixed price contract. Individual task orders will be issued for each period of performance, contingent upon availability of VA funding. Contract expiration date is 5 years from effective date of 04/01/2023; expiration date is 03/31/2028. 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. VISN 4 LOCATIONS INCLUDE: Name Title Office Telephone E-mail Address Odette Gonzalez-Ramos Acquisition Project Manager VISN4 Logistics/Procurement HUB (717)272-6621 xt.4579 Odette.gonzalez-ramos@va.gov Jennifer Harkins Medical Technologist Altoona VAMC (814) 943-8164 x17080 Jennifer.Harkins1@va.gov Patricia Engelsiepen Lab Supervisor Butler VAMC (878) 271-6880 Patricia.Engelsiepen@va.gov Karie Duke Lab Manager Coatesville VAMC (610)384-7711 x 3878 Karie.Duke@va.gov Bernadette Hall Lab Supervisor Erie VAMC (814) 860-2178 Bernadette.Hall@va.gov Jeanne Capparell Lab Manager Lebanon VAMC (717)272-6621 Jeanne.Capparell@va.gov Jason Tedrow Lab Supervisor Pittsburgh VAMC (412) 360-1534 Jason.Tedrow2@va.gov Joanna Bakanas QM Manager Wilmington VAMC (302)633-5404/4388 JoAnna.Bakanas2@va.gov 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 random access capability (if discreet testing is required) and be able to simultaneously perform the complete profile as described below 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 must maintain, or preferably reduce the number of workstations or overall labor required to accomplish the required testing by each laboratory. If Contractor offers a family of analyzers, VISN4 Laboratories technical evaluation panel will determine if instrumentation proposed meets needs of the facility. Equipment shall be acquired as listed in Attachment 1. Equipment must meet the volume and turnaround time requirements of the using facilities. STATs are typically 60 minutes from receipt in lab to verification in lab computer although it may vary by 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. Sigma performance may be included to support test quality. Expiration date must be clearly marked on reagent, standards and control containers. Unexpected changes in methodology/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. The Contractor shall provide a copy of all relevant permits/licenses and certifications inclusive of any sanctions current or pending throughout the United States of America in the proposal. 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. Vendors shall provide the VISN with Food and Drug Administration (FDA)-approved analyzer/equipment, reagents, controls, calibrators/standards, and any consumable part necessary for analyzing/testing. Vendor shall state any parameter/function that is pending FDA approval in their submission to the RFP. The quality of the products shall be within the acceptable proficiency testing standards of the College of American Pathologists (CAP) and Joint Commission (JC). Linearity material, quality control, and reagents, shall be consistent with current CLSI guidelines and related documents, College of American Pathologists (CAP) standards and Federal regulations. DEFINITIONS: Cost per Patient Reportable Result (CPRR)- Contractors are required to provide a price for a reportable patient result. The per patient reportable result price shall include costs covering: (1) installation of new equipment and 5-year equipment use, (2) all reagents, quality control, standards, calibrators, supplies, consumable/disposable items, printer paper, 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. This per patient reportable result price shall also encompass all costs associated with dilution; repeat and confirmatory testing required producing a single patient reportable result. It shall also include the material to perform as well as all other costs associated with 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)- 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, linearity materials, 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. TEST MENU: Refer to Attachment 1 for desired test menu and estimated annual volumes. 2.3.1 If the vendor does not manufacture all assays listed on the test menu, the proposed analyzers must be able to perform testing using third party reagent assay materials, calibrators, etc. so all listed tests can be performed on the proposed instruments without providing additional third-party instruments. 2.3.2. The vendor shall include a subcontracting plan in their offer in the event any tests require using third party reagent assays on the proposed analyzers. GENERAL REQUIREMENTS: Primary analyzer(s) Base equipment offered that shall fully support the scope of operations (minimal requirements). Depending upon the technical functionality and the capabilities of the individual manufacturer s instrumentation, one analyzer or multiple analyzers may be required to meet the productivity specifications defined herein. In those instances, the additional analyzer(s) shall, likewise, be considered primary instrumentation and shall meet all of the technical specifications of this solicitation. Those additional analyzer(s) offered meeting the definition of a primary analyzer shall be equivalent to a back-up analyzer (see definition below) and shall replace the requirement for offering that category of equipment. Back-up Analyzer: equipment required in support of operations for the VA laboratories in the event the primary analyzer(s) becomes non-operational/non-functional. This category of equipment shall only be operated during periods of time when the primary instrumentation is not available for use. As such, the requirements for consumable supplies, i.e. reagents, quality control material, calibrators, etc., shall be minimal and corollary to the successful operation of the primary instrumentation. Specific tests that require back-up performance are listed in Attachment 1. Operational Features- The instrumentation offered shall have the following: The capability of performing analysis on 100% of the tests listed in Attachment 1. Sufficient capacity and throughput to meet the volume/ service demands as defined in Attachment 1. 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. Contractor must provide a mechanism for the Clinical Laboratory to meet local discharge requirements (ie. mercury and formaldehyde SDS sheets must be provided in advance for review). A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system. The accuracy of the barcode reading must have less than a 1% failure rate. Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently. Equipment must accept, at a minimum, BCBC characters in specimen identifier that is alpha and/or numeric depending on site. Ability to prioritize STAT testing without compromising existing programmed testing. Menu flexibility to accommodate batch testing. Minimal daily, monthly, and periodic maintenance to include minimal hands-on maintenance processes. Ability to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage. On board reagent stability sufficient to accommodate both high and low volume use. Contractor to provide various reagent kit sizes to accommodate both high and low volume use. Analyzers must be able to accommodate 3rd party reagents. Contractor to provide expiration dates of at least six (6) months for reagents when available. No requirements for sample pre-treatment. Capability to detect out of range quality control and flag patient results and/or cease testing when quality control is out of range. Ability to accept various types of sample containers. Specimen indices (hemolysis, icteria, and lipemia) are required to be determined for each specimen at no additional charge. On board dilution capability (desired). Must have accurate metering capability for monitoring reagent usage or accept DVAMC s monthly LMIP statistics generated from VistA computer system. Technical Features- The instrumentation must be approved by the Food and Drug Administration (FDA) and shall have the following: On-board QC data management system with a minimum storage capacity of fifteen QC files and includes Levy-Jennings graphs. Analyzer must have the ability to capture, store and electronically transfer QC data. Ability to monitor instrument performance, preferably using a secure, direct data connection to a technical support center so instrument performance can be managed in real time. On board reagent inventory system. Automated inventory system preferred. Minimal carryover, no carryover preferred. Minimal reagent preparation, no reconstitution required is preferred. Accept serum, plasma, urine, CSF and other body fluids. Antigen excess checks (immunochemistry). Ability to run replicate testing with one sample. If not cap piercing, must have a decapper. Testing for adulteration of urine samples for DAU. Ability to change reagents while instrument is in operation is required (on the fly). Biotin free reagent technology. Onboard calibration and lot (calibrator and reagent) tracking. Majority of assays have multilevel calibrators (5 or 6) to decrease calibration verifications. Onboard calibration and quality control with automated calibration and quality control testing. Long calibration stability. Calibration frequency not to exceed once per 24 hours preferred during normal operations. Minimal specimen volume. During supply shortages, ability to assist with procurement of items such as specimen collection supplies is preferred. Contractor will provide a list of supplies for the analyzers that are required and assist in identifying potential changes to VA general supply inventories Adequacy of sample detection. Equipment performance evaluations will be based on at least the following: 2.4.4.22.1 Quality and accuracy of testing, 2.4.4.22.2 Amount of downtime of each analyzer, 2.4.4.22.3 Competence of service personnel, and 2.4.4.22.4 Number of times the service engineer has to return to fix the same instrument issue Other performance categories can be added or removed as needed. Hardware Features- The instrumentation shall have the following: A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory. Site specific needs of each facility must be adhered to when proposing equipment. No instrument(s) can emit excessive heat at any facility. Laboratory temperatures must remain at or about 22C for all facilities. Humidity must also be taken into account when proposing equipment. Electrical requirements of each facility may vary and must be adhered to. For sites with limited 220V power availability, equipment proposed must be compatible with the power limitations/availability of each site. The facility will not be required to create new power lines suitable for proposed equipment. Space requirements of each facility may vary and must be adhered to. Should any of the VA laboratories require a move of equipment to a new location during the course of the contract, the vendor will move equipment and perform all needed duties at a flat rate. 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 and accession or unique identifier number (UID). Contractor is responsible for the replacement and disposal of hardware (printers, monitors) should they become inoperable. An uninterruptible power supply with line conditioner for each instrument provided. Primary tube sampling. Clot detection. Modem to technical support to monitor instrument/QC performance. A quality control user group comparison program. Specific Equipment Requirements 2.4.6.1. Option for an Integrated Clinical Laboratory Chemistry/Immunochemistry Analyzer and Robotics System (Automated track or Connectivity). A turnkey system with single inlet and single outlet with connectivity to two or three chemistry analyzers and two immunochemistry analyzers will be provided. The contractor will be required to provide their own robotics system at the facility. 2.4.6.2. The Contractor shall be able to provide any incremental support equipment, e.g. water system, for their systems. Additional water systems may be requested at the facility level. All supplies needed for the incremental support equipment must be provided by the Contractor. Service and maintenance of the incremental support equipment is the responsibility of the Contractor. 2.4.6.3. The following are specifications for the automation system: 2.4.6.3.1. Data manager required. 2.4.6.3.2. Must be able to process/analyze STAT specimens from specimen input to test completion in less than 60 minutes, 45 minutes or less is preferred. 2.4.6.3.3. Inlet and outlet in the same footprint required with dedicated bypass lane for processing STAT samples preferred. 2.4.6.3.4. If one module becomes inoperable, other modules remain unaffected and continue testing patient samples. 2.4.6.3.5. Automated ability to balance workload to ensure optimal throughput. 2.4.6.3.6. Must be able to enclose specimens after test completion using either a cap or sealing material. Uncapping and recapping/sealing of specimens must be in an enclosed system to prevent distribution of biohazard or infectious aerosols. 2.4.6.3.7. Automated repeat and/or reflex testing based on established rules developed by the Laboratory. 2.4.6.3.8. Ability to auto-verify results. 2.4.6.3.9. Specimen archival through mapping of specimens to racks; for easy retrieval once moved off-line. 2.4.6.3.10. Automation system can be connected to other 3rd party analyzers and accept multiple tube types and sizes. 2.4.6.3.11. Smaller footprint preferred due to space constraints in the laboratory. 2.4.6.4. For those sites requiring back up analyzers, it would be desirable for the for the backup analyzer to be a mirror image or must have the same reagent requirement as the primary analyzer Method Performance/Validation Requirements 2.4.7.1 Method performance/comparison shall be at the expense of the Contractor, shall include linearity material, quality control, and reagents, and be consistent with current CLSI guidelines and related documents, College of American Pathologists (CAP) standards and Federal regulations. 2.4.7.2 Correlation studies for each analyte: A minimum of 30 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. 2.4.7.2.1 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. 2.4.7.2.2 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. 2.4.7.2.3 Sensitivity. Sensitivity may be validated concurrently with correlation studies. Mathematical calculations to determine efficiency, sensitivity, false positive rate and false negative rate are applied. 2.4.7.2.4 Specificity Studies. A review of product literature and assay inserts to determine any adverse effects for increased bilirubin, hemolysis, lipemia, or other interfering substances. 2.4.7.2.5 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. 2.4.8 Reference Range- A reference range must be determined for each test following CLSI/regulatory 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: 2.4.8.1 A verification of the manufacturer s suggested reference range may be performed as long as 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 50 reference individuals shall be used to verify the manufacturer s range. Any apparent outliers should be discarded, and new specimens obtained to provide a statistically valid verification. 2.4.8.2 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. 2.4.8.3 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. 2.4.9 Reports- The Contractor shall provide to the COR and 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 the facility, reporting the savings realized and shall be shared with 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 shall not be accepted. There will be no additional charges for any reports required. 2.4.9.1 All reports shall be submitted in accordance with the following schedule: Time Period Date Report Due January- March April 20th April- June July 20th July- September October 20th October- December January 20th The contractor shall provide a list of customers and using locations within a reasonable distance from participating facilities for potential site visits. Customer references should include those that are using the instrument models that are proposed for the DVMAC. 2.4.9.2 Ordering/Billing: Orders will be placed by individual DVMAC via I.M.P.A.C. purchase card or purchase order via telephone, mail, fax, or online. Billing will be monthly in arrears for the level of tests by each facility. Monthly payments include equipment, service, and reagents necessary to perform tests provided to the contractor. Deliveries will be F.O.B. destination. 2.4.9.3 Contractor performance evaluations will be based on at least the following: 2.4.9.3.1 Timeliness and accuracy of invoicing, 2.4.9.3.2 Timeliness and accuracy of quarterly sales reports, Other performance categories can be added or removed as needed. Support Features- 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 including: precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specificity at no cost to the Government. The Contractor shall perform all of the statistical analysis as stated in the Method Performance/Validation section above and report data in an organized, clearly comprehensible format. Training. The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility s services and minimally equivalent to the terms and conditions for key operator training. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide 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. The option to train key operators on site is at the discretion of each facility. The Contractor shall provide all necessary procedures manuals, troubleshooting manuals, and operator manuals (also available on computer disc format). Procedures should be in Clinical and Laboratory Standards Institute (CLSI) format. Equipment Preventative Maintenance/Repair Service. The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all primary and back-up instrumentation and any incremental support equipment, e.g. water system, offered according to the following terms: 2.4.10.5.1. Service Requirements 2.4.10.5.1.1. 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 30 minutes. 2.4.10.5.1.2. Equipment repair service shall be provided 7 day/ 24-hour on-site service as needed. All arrangements shall be coordinated between the Contractor and VA laboratory personnel. 2.4.10.5.1.3. Equipment repair response time at the site shall be no more than 2 hours for service personnel. 2.4.10.5.1.4. Preventative maintenance will be performed as frequently as published in manufacturer s operator s manual and within 2 weeks of the scheduled due date. Scheduled maintenance times should be flexible to minimize interruptions during peak workload times. 2.4.10.5.1.5. 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: 2.4.10.5.1.5.1. date and time notified 2.4.10.5.1.5.2. date and time of arrival 2.4.10.5.1.5.3. serial number, type and model number of equipment 2.4.10.5.1.5.4. time spent for repair, and 2.4.10.5.1.5.5. proof of repair that includes documentation of a sample run of quality control verifying acceptable performance. 2.4.10.5.2. Each notification for an emergency repair service call shall be treated as a separate and new service call. 2.4.10.5.3. Assist the user in setting up and maintaining/troubleshooting user-defined assays. 2.4.10.5.4. If the equipment provided by the contractor is requiring repair and is down in excess of 24 hours and no functional back-up analyzer is provided, the Contractor is to bear the cost of testing at an alternative location until the equipment is returned to a fully functional level. 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 procurement; 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 procurement as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. cabinetry to support/house the analyzer (if necessary), 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, etc. The Contractor will notify, within 24 hours, all participating facilities of any recalled reagents or equipment components. This must be accomplished by telephone, email, and/or certified mail. The contractor will provide sufficient replacement items to resolve the problem so no break in service is realized. In the case of a company merger and/or acquisition, the contractor will immediately notify the COR and Contracting Officer and provide a contingency plan of services to assure that no break in services is realized by the participating facilities. The Contractor shall provide a directory with the names and telephone numbers of all contact persons to be used by the participating facilities to inquire about billing issues, reagent shipments, service concerns, etc. The contractor is encouraged to quote a spectrum of value added incentives. Such incentives may include customer and professional service programs (ie. PACE approved continuing education programs for clinical laboratory staff) and new innovations to assist the VA facilities with the usage of the contractor s products/services in the most efficient manner. Interface Requirements The Contractor shall be responsible for providing all hardware required for the connection, implementation, and operation of the interface to the universal interface and any incremental fee that is required each time an instrument is added to an existing universal interface system (see Attachment 1). The Contractor shall provide any and all necessary software support for ensuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself. Information necess...