Loren Data's SAM Daily™

FBO DAILY - FEDBIZOPPS ISSUE OF JUNE 14, 2015 FBO #4951
DOCUMENT

Q -- Chemistry/Hematology/Immuno Testing Services 6/8/15 - assigned to CS for processing - Attachment

Notice Date

6/12/2015
 

Notice Type

Attachment
 

NAICS

541380 — Testing Laboratories
 

Contracting Office

Department of Veterans Affairs;Network Contracting Office 4
 

Solicitation Number

VA24415N1019
 

Response Due

7/10/2015
 

Archive Date

8/9/2015
 

Point of Contact

Jennifer Callahan
 

E-Mail Address

jennifer.callahan4@va.gov
(jennifer.callahan4@va.gov)
 

Small Business Set-Aside

N/A
 

Description

Sources Sought Notice Chemistry/Immuno/Hematology Laboratory Testing Services for Veterans Integrated Service Network (VISN) 4 The Department of Veterans Affairs, VISN 4 Medical Centers, is seeking information regarding Chemistry/Immuno/Hematology Laboratory Testing Services. The Performance Work Statement can be seen on the following pages. If your company can meet the requirements of this Sources Sought notice, please email the following information to the Contracting Officer (Jennifer.Callahan4@va.gov) NLT July 10, 2015. Phone inquiries will not be accepted. "Are the services covered under a GSA schedule? If so, what is your company's GSA schedule number? "Socioeconomic size status of your company "Confirmation that your company is registered in SAM "Any comments/concerns with the Performance Work Statement "Past Performance information, including whether or not your company has performed these services for the Department of Veterans Affairs "Other relevant information Thank you in advance for your support. ? Statement of Work Chemistry/Immunoassay/Hematology 1. BPA LANGUAGE 1.1.INTENT: Pursuant to Federal Supply Schedule (FSS) and FSS Contract Clause I-FSS-646, it is the intent of the Department of Veterans Affairs, (herein afterwards referred to as VISN 4) to establish a Blanket Purchase Agreement (BPA) for Laboratory Instrumentation- Automated Chemistry Immunochemistry and Hematology. The Government reserves the right to award a CPRR BPA to multiple Contractors for Laboratory Instrumentation- Automated Chemistry Immunochemistry and Hematology. Additional tests/reagents/instrumentation may be added to the BPA as new technology becomes available on the market and added to the base FSS contract. 1.2.ORDERS: All products ordered under this BPA, placed against the Federal Supply Schedule Award Contract(s), are subject to the terms and conditions of the FSS contract. This BPA does not obligate any funds. The Government is obligated only to the extent of authorized orders actually issued under the BPA by authorized individuals. In the event of any inconsistency between the provisions of the BPA and the provisions of the Federal Supply Schedule Contract then the FSS Contract provisions will take precedence. 1.3.PRICES AND TERMS: VISN 4 has provided an estimated volume by test as reflected in Section D 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 Section D, but does not guarantee volumes as listed; they are estimates ONLY. 1.4.TERM OF AGREEMENT: As a result of this solicitation, the Government reserves the right to award to multiple offerors, a firm-fixed price BPA with one base year and four, one year option periods. The BPA shall be effective for the term of the FSS Contract including additional FSS extensions. Each station will place Deliver/ Task Orders against the BPA. The Contractors are required to immediately notify the CO (Government Contracting Officer), in writing, if at any time the FSS contract upon which this BPA is based, is no longer in force. The resulting BPA shall be automatically extended for the remaining term of the BPA without modification upon any extensions of the Contractor's FSS contract. In addition, where a new FSS contract replaces Contractor's current FSS contract, the resulting BPA may be reassigned under the new FSS contract for the remaining term of the BPA with written agreement between Contractor and the contracting officer. This BPA is not a contract. If the Contractor fails to perform in a manner satisfactory to the CO, this BPA may be canceled with thirty (30) days written notice to the Contractor by the CO. The Contractor shall also reserve the right to terminate this contract with 30 days notification to the CO. This BPA shall be reviewed annually. VISN 4 intends to establish the base year of the agreement for the period of April 1, 2016 - March 31, 2017. The final option period is expected to expire on March 31, 2021. 1.5.IDENTIFICATION: Delivery Orders issued shall be identified by their applicable FSS Contract Number and BPA Number. FSS & BPA identification numbers are assigned through the VHA Procurement Activity; FSS Schedule TBD. 1.6.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. ? 2. STATEMENT OF WORK/DESCRIPTION/SPECIFICATIONS 2.1.1.The Laboratory instrumentation equipment shall have the capability of performing or reporting the clinical parameters as defined herein. The proposed instruments shall have random access capability (if discrete testing is required) and be able to simultaneously perform the complete profile as described below meeting 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). 2.1.2.Equipment must maintain, or preferably reduce the number of work stations or overall labor required to accomplish the required testing by each laboratory. 2.1.3.Since the systems will have the capacity count of patient data for up to 24 hours in memory, the equipment memory must be RPS 140-2 encryption compliant. Systems will possess the ability to backup data to a CD/DVD or other external medium (any external storage device must be RPS 140-2 compliant and be approved by facility CIOs and ISOs for use prior to implementation in any VISN facilities). Instruments will be capable of interfacing with VISTA/CPRS via Data Innovations or Dawning interface. The Contractor will identify if removable media is required to perform their duties and conform to VA mobile media policies. The BIOMED Department will ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device/system. Any hardware (hard drives/memory, etc.) capable of storing sensitive data must be returned to the VA for destruction prior to the equipment leaving any facility for replacement or repair. 2.1.4.If the Contractor offers a family of analyzers, the VISN 04 evaluation panel will determine if the instrumentation proposed meets the needs of VISN 4. 2.1.5.Equipment will be acquired for each of the clinical laboratories located at Government VISN4 facilities listed in Section D at the time of the award. Please note if a facility's volume dictates an upgrade of equipment, it shall be accomplished by modification to the BPA. Modifications to the BPA are done at the sole discretion of the Government Contracting Officer. 2.1.6.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. The 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 VA individuals determined at contract award. 2.1.7 In the event that the supplies are found to be defective and unsuitable for use with the Contractor's equipment, or the Contractor(s) have failed to comply with the requirements for routine supply delivery, the Contractor(s) are required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor(s) 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 each Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery. 2.2 DEFINITIONS 2.2.1.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. This per patient reportable result price shall also encompass all costs associated with dilution; 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. 2.2.2.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. 2.2.3.Parameter definitions- "CBC- Complete Blood Count "WBC- White Blood Cell Count "Diff- Automated Differential "RBC- Red Blood Cell Count "MCH- Mean Corpuscular Hemoglobin "MCV- Mean Corpuscular Volume "MCHC-Mean Corpuscular Hemoglobin Concentration "RDW- Red Cell Distribution Width "MPV-Mean Platelet Volume 2.2.4. Complete Blood Count (CBC) and White Blood Cell (WBC) Automated Differential (DIFF) and Reticulocyte: "CBC with five-part WBC Diff shall include the following parameters at a minimum: hemoglobin, hematocrit, WBC, RBC, platelet, MCH, MCV, MCHC, RDW, and MPV. Five-part WBC Diff shall include at a minimum: % neutrophils, % lymphocytes, % monocytes, % eosinophils, and % basophils. "CBC with three-part WBC Diff shall include the following parameters at a minimum: hemoglobin, hematocrit, WBC, RBC, platelet, MCH, MCV, MCHC. Three-part WBC Diff shall include at a minimum: % granulocytes, % lymphocytes, and % monocytes. "Accepts body fluid samples for analysis, body fluid analysis with diff preferred. 2.2.5.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. 2.3.TEST MENU: Refer to Section D for desired test menu and estimated annual volumes by laboratory. 2.4.GENERAL REQUIREMENTS 2.4.1.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 may serve as a back-up analyzer (see definition below) and shall replace the requirement for offering that category of equipment. 2.4.2.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. Backup equipment is required for Chemistry, Immunochemistry, and Hematology. 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 Section D. Additional primary analyzers required for the performance of daily workload are not considered back-ups for the purposes of consumables, reagents, etc. 2.4.3.The Contractor shall provide quality control materials at a minimum of three levels: Low, Normal and Elevated/Abnormal for Hematology. All reagents, controls, calibrators, will be supplied and lot numbers will have maximum dating. 2.4.4.Operational and Technical Features- The instrumentation offered shall have the following Features: "Capability of performing analysis on 100% of the tests listed in Section D. "A specimen management system to manage and track sample progress and position. "Specimen archival through mapping of specimens to racks or refrigerated storage; for easy retrieval once moved off-line. "The ability, based on test requests, to sort specimens. "The ability to send processed specimens by means of a tracking system to the proper testing instrumentation to maximize efficiency and to maintain and standardize turnaround times of results. "The ability to prioritize STAT specimens. "Minimal operator intervention to introduce STAT specimens or to change a routine specimen to a STAT specimen. "The ability to detect processing errors and provide error notification. "The ability to separate the serum/plasma from the blood cells through the process of centrifugation. "The ability to remove the collection caps from a variety of types and sizes of blood collection tubes. "The ability to replace and/or reseal a variety of types and sizes of blood collection tubes. "The ability to remove a segment of serum/plasma and move into another specimen tube. "The flexibility to automatically aliquot specimens post-analytically. "The ability to connect by a line or track system all primary and back-up testing analyzers offered in accordance with Section D. "The ability to maintain and store specimens from 2-8 degrees centigrade. "Barcoding stations located at key points along the line or track system must have the following capabilities: oThe accuracy of the barcode reading must have less than a 1.0 % failure rate. oEquipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently. oEquipment must accept, at a minimum, 10 characters in specimen identifier that is alpha, numeric, and/or alphanumeric concurrently. oIf there is an existing Line/Track System that the VISN 4 facility owns, the proposed equipment must be capable of connecting to and operating with said Line/Track system. 2.4.5.Primary Processing Automation Line Instrumentation. Offering for an Integrated Clinical Laboratory Chemistry/Immunochemistry Instrumentation and Robotics System (Automated track or line) in accordance with the requirements of each respective laboratory, as listed in Section D, shall have the following or sufficient capacity and throughput to meet the volume and service demands as defined in Section D. 2.4.6.Testing Instrumentation The testing instrumentation shall have the following: "The capability of performing analysis on the tests listed in Section D. "Sufficient capacity and throughput to meet the volume and service demands as defined in Section D. "An instrument management system (internal to testing instrumentation) that provides/maintains the following: "Ability to monitor instrument performance. "Continuous monitoring of vital functions with immediate operator notification of failure(s) and on-board storage of these records. "Capability to detect and alert operator of out of range quality control results via flagged results on QC printout and visual alerts on display monitor. "Ability to store and retransmit patient records to the VA Laboratory Information system for a minimum 24 hours in case of interface outage. "Capability to record, store and print the following information: "Required quality control and instrument maintenance information. "Patient demographic information and specimen results. "On board reagent inventory system. "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 1.0 % 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, 10 characters in specimen identifier that is alphanumeric that may be enabled concurrently. "Bar coding of reagents and the ability to track reagent containers throughout the testing process through the use of bar code technology. "Ability to prioritize STAT testing without compromising existing programmed testing. "Minimal operator intervention to introduce STAT specimens or to change a routine specimen to a STAT specimen, as well as introduce STAT specimens during a test run without aborting a run. "On board reagent stability sufficient to accommodate both high and low volume use. "The ability to detect and alert operator of low liquid levels and the potential of depletion. "The ability to unload/remove empty reagent containers from the equipment during operation without interrupting testing in progress. "The ability to support multiple reagent lots of the same reagent on the equipment at the same time with active, valid calibrations. "The ability to calibrate more than one lot of a reagent at a time. "The capability to calibrate assays during test run without aborting the run. "The capability to store, print, and retrieve calibration data. "For routine (general) chemistry tests, when more than one lot of a given reagent has a valid calibration and quality control material is programmed to run as a control (in the control mode): "Quality control material will automatically be run on all lots of those reagents when the respective test is requested. "Quality control results will be easily distinguishable i.e., identified by reagent lot number or similar mechanism, on instrument printout or display monitor. "Operator may select to run a test on only a specified lot of reagent even though more than one lot has a valid calibration "The ability to continuously load patient specimens. "The ability to detect short samples. "Clot detection with alert notification. "Primary tube sampling from various manufacturers and sizes of evacuated tubes. "The instrumentation shall be capable of handling all routine sample collection tubes plus other various sized sample containers i.e., sample cups (0.5, 1.0, and 2.0 ml), carrier tubes and tube inserts. "The capability to auto dilute a test when defined limits are exceeded. (Contractor shall list all analytes that can be set to auto dilute on each instrument model offered.) "The capability to program a test as a repeat with interfacing of results to overlay initial result. "Safety features to avoid unnecessary exposure to bio-hazardous and chemical material. The exposure to and the volume of bio-hazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling. "For those sites requiring back up analyzers, it would be desirable for the backup analyzer to be a mirror image or have the same reagent requirement as the primary analyzer. "Ability to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage. "IDMS traceable Creatinine reagent. "Minimal requirements for sample pre-treatment. "Minimal carryover. "Long calibration stability. "The capability of incorporating other manufacturer's reagents. ? 2.4.7.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. "All monitors/screens will clearly display information in all light conditions. "A printer(s) 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). "An uninterruptible power supply (UPS) with line conditioner for each instrument provided. (This includes UPS units for sites with automation lines, specimen management systems, data management systems, refrigerated storage, etc,) Each UPS must provide electrical power for a minimum of 15 minutes after electrical power fails and the system must allow for an automatic controlled shutdown to prevent damage to the instrument and data records. 2.4.8.Specific Equipment Requirements- "Reagent inventory management system to provide reagent data to include but not limited to lot number, expiration date, total tests, and remaining tests is desired. "Patient testing is disabled if QC failure occurs. "The technology to electronically transmit quality control and instrument function checks and maintenance information to the Contractor Middleware Management System. "The technology to print results in real-time or on demand, as well as option to print exceptional reports held in the middleware for auto-verification purposes. "Equipment installation and possible reinstallation should the equipment need to be moved due to construction or laboratory redesign at no additional cost for one (1) location within each site. "The CPRR reportable price shall include all costs and the provision of items as defined with the exception of controls for daily quality control (QC) analysis. The labs use third party controls for daily QC analysis, however, the Contractor shall provide as part of the CPRR pricing, at no additional charge, Contractor assayed control products for lot changes and troubleshooting purposes as necessary. 2.4.9 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. All studies performed will be appropriate for the test menu of the respective laboratory to include serum, plasma, urine and body fluids as applicable. "Correlation studies for each analytes at each VISN 4 site. 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 analytes 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 include, at a minimum, within run precision study of 10 normal and 10 abnormal controls. 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. "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. 2.4.10.Reference Range- 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 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 20 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. "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. 2.4.11. 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 BPA. All reports shall be submitted in accordance with the following schedule: Time PeriodDate Report Due January- MarchApril 20th April- JuneJuly 20th July- SeptemberOctober 20th October- DecemberJanuary 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. 2.4.12.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 included on the list of supplies defined in the Federal Supply Schedule contract and required to establish instruments for operation for performance of acceptance testing. This applies to all equipment as well as additional or replacement equipment placed under the terms and conditions of this BPA. The Contractor shall perform/assist, 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 provide a hard-copy of 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 training defined in the Contractor's Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers contract. This shall include training on the operation of the system, data manipulation, and basic troubleshooting and repair for two key operators. 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. 2.4.12.4. In addition to the training above the following shall be provided: "Basic operator training shall be provided by Contractor on site for all operators on all shifts, as applicable. "Advanced training shall be provided on instrument troubleshooting, advanced middleware rules writing, data analytics, report writing and customization should be available as in training. "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, primary processing automation line instrumentation and any incremental support/ancillary equipment, e.g. water system, printers, etc. offered according to the following terms: 2.4.12.6. Service Requirements- "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 2 hours. "Equipment repair service shall be provided during routine business hours which are typically 8 am to 430 pm. See Section D for a listing 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 but sooner if possible. "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. "Each notification for an emergency repair service call shall be treated as a separate and new service call. 2.4.12.16. 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 BPA; however, it does refer to significant changes in the hardware operational capability. 2.4.12.17. Ancillary support equipment - The Contractor shall provide, install and maintain through the life of the BPA, 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, preventative maintenance and repair, etc.), printers 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. 2.4.12.18. Interface Requirements 2.4.12.19. 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 Section D). 2.4.12.20. The Contractor shall provide any and all necessary software support for insuring 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 necessary to make the determination for type and amount of interfacing equipment is supplied in Section D. 2.4.12.21. If a site already has a universal interface system, the Contractor is responsible for everything leading up to the connection to the software system, including any incremental fee required to add additional equipment (e.g. licenses, ports/cards, cables, software, etc.) to the universal interfacing system. 2.4.12.22. If a site does not have a universal interface and one is needed to optimally interface the instrument, then the Contractor is responsible for the acquisition of the universal interface box and everything else needed to connect with VA computerized hospital information system. 2.4.12.23. If there are any software upgrades in the instrument during its life, the Contractor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VA computerized hospital information system. 2.4.12.23.1. The Specimen Management system must contain computer interface compatible with the current VA laboratory information system and existing universal interface. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system. 2.4.12.24. Commercial offerings - The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and assists in regulatory compliance, e.g. Computer disc containing their procedure manual in CLSI format or an on-line procedure manual in the instrument software. 2.4.12.25. 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. 2.4.12.25.1.The determination and description shall address the following: oWaste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24) oWaste ignitability (Reference 40 CFR §261.21) oWaste corrosivity (Reference 40 CFR §261.22) oWaste reactivity (Reference 40 CFR §261.23) oHazardous waste from non-specific sources (F-listed) (Reference 40 CFR §261.31) oDiscarded commercial products (acutely toxic or P-listed and toxic or U-listed; Reference 40 CFR §261.33) oSolid Waste (Reference 40 CFR §261.2) oExclusions (Reference 40 CFR §261.4) 2.4.12.25.2.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. 2.4.12.25.3.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 §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 §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: "Barium "Cadmium "Chromium "Copper "Cyanide "Lead "Mercury "Nickel "Silver "Zinc "Arsenic "Selenium "Tin "pH "Flash point (to higher than 200 degrees F) BOD; biochemical oxygen demand 2.4.12.25.4.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 or not the waste from each device can legally be disposed of via the sewerage system 2.4.12.26.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 BPA. This timeline is based on a reasonable attempt of the Contractor to complete all of 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. 2.4.12.26.1.Upon award of a BPA, the transition period for the awarded BPA to have all equipment and peripherals installed and operational shall be from date of award through 90 days. During this same period all initial training of VA personnel in the operation and maintenance of said award shall also be completed. 2.4.12.26.2.Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor's submitted plan shall not exceed 90 days for the transition of all services under the awarded BPA including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations. Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate BPA for cause under the Termination for Cause clause of the BPA. 2.4.12.26.3.At the end of 90 days from award of the BPA, the awarded Contractor shall have full and sole responsibility for services under the awarded BPA. 2.4.13.Standard and Quality of Performance- This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the delivery order [or BPA] is accepted by the Government. This also includes replacement, substitute machines and machines that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the Contractor's technical specification or as quoted in any BPA at an effectiveness level of 90% or more. 2.4.13.1.In the event that equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests shall continue on a day-by-day basis until the standard of performance is met for a total of 30 consecutive days. 2.4.13.2.If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order in accordance with the provisions of FAR 52.212-4 entitled "Termination for cause." (The Contractor shall receive revenue for tests reported during the 90-day acceptance period.) 2.4.13.3.Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period of time when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the Government makes a bona fide attempt to contact the Contractor's designated representative at the prearranged contact point until the system or machine(s) is returned to the Government in proper operating condition. 2.4.13.4.During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work shall be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when in excess of the minimum of 100 hours. [reference: Master FSS] (Per FSS awarded contract which can be found at www.gsa.gov). 2.4.13.5.The Government will maintain daily records to satisfy the requirements of the Standard and Quality of Performance section and shall notify the Contractor in writing of the date of the first day of the successful period of operation. Operations use time and downtime shall be measured in hours and whole minutes. 2.4.13.6.During the term of the BPA, should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the COR and/or contracting officer to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer's instructions, shall be solely that of the Contractor. [reference: Master FSS] (Per FSS awarded contract which can be found at www.gsa.gov). Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the agreement for equipment. The same terms and conditions apply to ancillary/support equipment provided under this BPA, i.e., water system UPS, etc. 2.4.14.Government's Responsibility- The user will perform routine maintenance and cleaning as required in the manufacturer's operation and maintenance instructions. The user shall maintain appropriate records to satisfy the requirements of this paragraph. 2.4.15.Ownership of Equipment- Title to the equipment shall remain with the Contractor. All accessories (unused consumables, etc.) furnished by the Contractor shall accompany the equipment when returned to the Contractor. The Contractor, upon expiration of order(s), at termination and/or replacement of equipment, shall remove the equipment. The Contractor shall disconnect the analyzer (gas, water, air, etc.) and shall be responsible for all packing and shipping required to remove the analyzer. 2.4.16.The Contractor will identify if removable media is required to perform their duties. The Clinical Engineering Department will ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device/system. Any Contractor with patient sensitive information that is imported into the removable media device for any reason must purge all patient sensitive information prior to departure from the facility. 2.4.17.Prior to termination or completion of this BPA, Contractor/subcontractor must not destroy information received from VA, or gathered/created by the Contractor in the course of performing this BPA without prior written approval by the VA. Any data destruction done on behalf of VA by a Contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the Contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination or completion of the BPA. 2.4.18.All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the BPA or (ii) disposal or return of the IT equipment by the Contractor/subcontractor or any person acting on behalf of the Contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the Contractors/subcontractors that contain VA information must be retained by the VA for sanitization or destruction or the Contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination or completion of the BPA or disposal or return of the IT equipment, whichever is earlier 2.4.19.Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the Contractor at the end of lease, for trade-in, or other purposes. The options are: 2.4.19.1.Contractor must accept the system without the drive; 2.4.19.2. VA's initial medical device procurement includes a spare drive which must be installed in place of the original drive at time of turn-in; or 2.4.19.3.VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase. 2.4.20.Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then; 2.4.20.1.The equipment Contractor must have an existing BAA if the device being traded in has protected health information stored on it and hard drive(s) from the system are being returned physically intact; and 2.4.20.2.Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or BPA. 2.4.20.3.A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The Information Security Officer (ISO) needs to maintain the documentation.
 

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File Name: VA244-15-N-1019 VA244-15-N-1019.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2103852&FileName=VA244-15-N-1019-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2103852&FileName=VA244-15-N-1019-000.docx

 

File Name: VA244-15-N-1019 DESCRIPTION.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2103853&FileName=VA244-15-N-1019-001.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2103853&FileName=VA244-15-N-1019-001.docx

 

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Record

SN03763571-W 20150614/150612235747-7764e5938c45ec4d09a122551ec76946 (fbodaily.com)
 

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