FBODaily.com | FedBizOpps: SRCSGT | 66 | AMA Coagulation Analyzers

FBO DAILY - FEDBIZOPPS ISSUE OF MARCH 31, 2019 FBO #6337
SOURCES SOUGHT

66 -- AMA Coagulation Analyzers

Notice Date: 3/29/2019
Notice Type: Synopsis
NAICS: 334516 — Analytical Laboratory Instrument Manufacturing
Contracting Office: 00504;Department of Veterans Affairs;Contracting Section;7201 I-40 West Suite 100;Amarillo TX 79106
ZIP Code: 79106
Solicitation Number: 36C25719Q0524
Response Due: 4/9/2019
Archive Date: 6/8/2019
Point of Contact: robyn.nussbaum@va.gov
Small Business Set-Aside: N/A
Description: The Amarillo VA Health Care System (AVAHCS) in Amarillo, Texas is seeking Service Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), and other small business sources capable of meeting the requirement listed below. The acquisition will be accomplished using commercial item procedures in accordance with FAR Part 12. NOTE: TO QUALIFY SDVOSB AND VOSB VENDORS MUST BE CERTIFIED IN THE VA VENDOR INFORMATION PAGES (VIP) DATABASE. The North American Industry Classification System (NAICS) is 334516. Any SDVOSB, VOSB, or small business firms who wish to identify their interests and capability to provide this product must provide product specifications, performance and delivery information by notifying the Contract Specialist no later than NOON PM Central Time, April 9, 2019. Notification shall be e-mailed to Robyn Nussbaum, at robyn.nussbaum@va.gov. Any vendor who responds to this Notice must provide credentials to perform the requirement as outlined in the below scope. DISCLAIMER This Sources Sought Notice is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this Notice that is marked as proprietary will be handled accordingly. In accordance with the Federal Acquisition Regulation, responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this Notice. SCOPE: 1.1.1. 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) be able to simultaneously perform the complete profile 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). 1.1.2. Equipment must maintain, or preferably reduce the number of work stations or overall labor required to accomplish the required testing by each laboratory. 1.1.3. If Contractor offers a family of analyzers, VISN 17 technical evaluation panel will determine if instrumentation proposed meets needs of using facility. 1.1.4. Equipment shall be acquired for each of the clinical laboratories located at the VISN facilities listed in Attachment A. 1.1.5. 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/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. 1.1.6. 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. 1.2. GENERAL REQUIREMENTS: 1.2.1. Primary analyzer(s) (Two analyzers for Amarillo VAHCS and one analyzer for Lubbock CBOC) Must be the same analyzers. 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. 1.2.2. (Applies only if selected) Mirrored Back-up Analyzer(s) - 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 A. 1.2.3. Contractor shall provide quality control material at a minimum of two levels; normal and elevated/abnormal levels. 1.2.4. All reagents, controls, calibrators, and normal donor plasma (for annual lot changes) will be of the same lot number for all users. Lot numbers will be in use at least twelve (12) months. All sites covered under this CONTRACT will convert to the new yearly lot number within 2 months of each other. 1.2.5. Assayed control plasma for PT and APTT are the preferred products to assess test quality. If assayed controls are not offered/available, the Contractor shall either: 1.2.5.1. Furnish assayed control plasmas to be run concurrently until a range can be established for the unassayed material. 1.2.5.2. Provide documented peer review of unassayed control data. 1.2.6. The product information must specify an appropriate ISI for the instrument and reagent lot number combination. 1.2.7. The ISI value for PT reagents must be between 1.0-1.3. The variance of the ISI value between reagent lots must not exceed 0.2. 1.2.8. Electronic barcode technology must be used to enter the ISI value. 1.2.9. Documentation must be provided regarding the effect of lupus anticoagulants in the therapeutic monitoring of warfarin. 1.2.10. Interference of heparin in the PT reagent must be minimal. 1.2.11. The PT / INR must be validated by the manufacturer to a value high enough to calculate an INR of at least 10.0. This a mandatory requirement by the Amarillo VA Healthcare System Warfarin Maintenance Dosing Protocol (see attachment page 17). 1.2.12. Operational Features- The instrumentation offered shall have the following: 1.2.12.1. The capability of performing analysis on 100% of the tests listed in Attachment A. 1.2.12.2. Sufficient capacity and throughput to meet the volume and service demands as defined in Attachment A. 1.2.12.3. Safety features to avoid unnecessary exposure to biohazardous and chemical material (cap piercing capability). 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. 1.2.12.4. 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. 1.2.12.4.1. The accuracy of the barcode reading must have less than a 1% failure rate. 1.2.12.4.2. Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently. Equipment must accept, at a minimum, BARC characters in specimen identifier that is alphanumeric. 1.2.12.5. Ability to prioritize STAT testing without compromising existing programmed testing. 1.2.12.6. Minimal daily, monthly, and periodic maintenance. 1.2.12.7. Ability to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage. 1.2.12.8. Capability to store a minimum of 4000 patient records in a database for immediate recall. 1.2.12.9. Ability to accept various types of sample containers. 1.2.12.10. Ability to handle lipemic or icteric samples. 1.2.12.11. An on-board refrigeration system for reagents. 1.2.12.12. Minimum twenty-four (24) hour on-board stability of PT and APTT reagents. 1.2.12.13. Minimum eight (8) hour stability of quality control (QC) material. 1.2.12.14. Capability to detect out of range quality control. 1.2.12.15. Ability to automatically program the performance of QC testing. 1.2.12.16. On board reagent stability sufficient to accommodate both high and low volume use. Contractor to provide expiration dates of at least 12 months for reagents. 1.2.13. Technical Features- The instrumentation must be approved by the Food and Drug Administration (FDA) and shall have the following: 1.2.13.1. On-board QC data management system with a minimum storage capacity of 30 QC files and includes Levy-Jennings graphs. Analyzer must have the ability to capture, store and electronically transfer QC data. 1.2.13.2. Ability to monitor instrument performance. 1.2.13.3. On board reagent inventory system. 1.2.13.4. Minimal carryover. 1.2.13.5. Long calibration stability. 1.2.13.6. Minimal reagent, calibrator, and control preparation. 1.2.13.7. No specimen pre-treatment required for PT and APTT testing. 1.2.13.8. Ability to accommodate the use of third party reagents for specialized testing. 1.2.14. Hardware Features- The instrumentation shall have the following: 1.2.14.1. A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory. 1.2.14.2. An on-board monitor/screen that is easily readable. 1.2.14.3. A printer that has the capability of printing a patient report with patient demographic information that includes minimally the accession or unique identifier number (UID). 1.2.14.4. An uninterruptible power supply with line conditioner for each instrument provided. 1.2.14.5. Primary tube sampling. Specific Equipment Requirements- 1.2.14.6. Ability to perform calibration curves on other assays during test run without aborting the run. 1.2.14.7. Ability to store, print and retrieve calibration curves where applicable. The instrument must store, print and retrieve curves for factor assays, such that using same lot numbers and patient specimens may be run rapidly and on a STAT basis. 1.2.14.8. Instrument must have the ability to run tests on current and new lot numbers simultaneously for yearly population and Lot Rollover studies. 1.2.14.9. Ability for the curve dilutions to be defined by the operator and the curves should be stable for a minimum of three (3) days. 1.2.14.10. D Dimer testing must be FDA approved for exclusion of PE and DVT. 1.2.14.11. Ability to accept closed tube samples. 1.2.14.12. Ability to create rerun/reflex rules. 1.2.14.13. Ability to replenish reagents while the analyzer is in operation. 1.2.14.14. Ability to comment on QC points to document troubleshooting and QC review. 1.2.14.15. Analyzer utilizes windows operating software. 1.2.15. Method Performance/Validation Requirements- 1.2.15.1. Method performance/comparison shall be at the expense of the Contractor, shall include linearity material and reagents as required or recommended based on manufacturer s specifications, and be consistent with current CLSI guidelines and related documents, College of American Pathologists (CAP) standards and Federal regulations. Acceptable accuracy and precision for PT, APTT, Heparin Xa and Fibrinogen will be <10% CV and D-Dimer will be <5% CV. The method validation will include the following: 1.2.15.1.1. Correlation studies for each analyte. A minimum of 50. samples spanning the reportable range, shall be run by the present and the proposed method. Contractor shall analyze results and provide statistical data to support acceptance of the new method. Statistics shall consist of at least mean, bias, slope, y-intercept, correlation coefficient, and meet current standards defined by CLSI. 1.2.15.1.2. Analytical Measurement Range (AMR) Validation shall be performed on proposed instrument(s) for each analyte to validate the reportable range when applicable. 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. 1.2.15.1.3. 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. Where applicable, intra-VISN facility variations should be kept at an absolute minimum. 1.2.15.1.4. Sensitivity. Sensitivity may be validated concurrently with correlation studies. Mathematical calculations to determine efficiency, sensitivity, false positive rate and false negative rate are applied. 1.2.15.1.5. Specificity Studies. A review of product literature and assay inserts to determine any adverse effects for increased bilirubin, hemolysis, lipemia, or other interrupting substances. 1.2.16. 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: 1.2.16.1. 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 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. 1.2.16.2. 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. 1.2.16.3. 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. 1.2.17. Reportable Range Requirements- 1.2.17.1. PT, APTT, Fibrinogen, High sensitivity D-Dimer, and heparin assays Contractor shall provide accurate high and low reportable range limits for all clotting assays (i.e., PT, APTT and fibrinogen), particle agglutination (immunological) assays (i.e., D-dimer) and chromogenic assays (i.e., heparin anti-factor Xa assay and antithrombin activity). The PT/INR must be validated by the manufacturer to a value high enough to calculate an INR of at least 10.0. This a mandatory requirement by the Amarillo VA Healthcare System Warfarin Maintenance Dosing Protocol (see attachment page 17). 1.2.17.2. Factor Assay Activity Contractor shall determine a reportable range for all coagulation factors, exhibiting the lowest and highest level of factor activity that can be accurately reported. This determination should be based on a known amount of factor activity plotted against seconds. The reference plasma that is used should be calibrated to a World Health Organization (WHO) standard or a secondary standard. The reportable range determination should be performed for all intrinsic, extrinsic, and common coagulation factors. The reportable range is determined by setting automatic re-dilutions at the highest standard curve point and the lowest standard curve point. The lowest valid point on the curve is used to define the sensitivity of the assay. The lower limit of detection must be <1%. This should apply to all activity assays. 1.2.17.3. Chromogenic Assays Contractor shall provide or determine a reportable range for chromogenic assays. This study should define the lowest level to the highest level that can be accurately reported. The material used to calibrate the instrument must not be used to determine the reportable range. The sample material used must have a known reference value. A linearity study, if applicable, must be performed to verify the reportable range. 1.2.17.4. For all other tests determined at the site visit (immunologic assay, vWF Ag, PC, PS, etc.), Contractor shall provide or determine a reportable range following the protocols defined for Factor Assay Activity or Chromogenic Assays. 1.2.18. (Applies only if selected) Therapeutic Range Requirements- 1.2.18.1. An ex vivo range must be established. The therapeutic APTT range must be determined using plasma from patients on unfractionated heparin therapy, if possible. Slightly, moderately, and very prolonged APTT values must be used. Anti-Xa results must be performed to quantify the amount of heparin present relative to the APTT. A minimum of 50 patient samples must be used. An explanation of this protocol may be found in the current CLSI guideline on one-stage PT and APTT testing. If ex-vivo procedure cannot be performed due to limited appropriate samples, an in-vitro method should be used for Heparin Response Curve. 1.2.18.2. In changing activated partial thromboplastin time (APTT) methods, preference is given to a reagent system that will provide the same (or nearly the same) heparin responsiveness as the one currently in use. 1.2.19. 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 CONTRACT. Attachment C may be used as a template to provide these quarterly reports. 1.2.20. Support Features- 1.2.20.1. 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. 1.2.20.2. 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. 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. 1.2.20.3. 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 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. 1.2.20.4. 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: 1.2.20.4.1. Service Requirements 1.2.20.4.1.1. 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 1 hour. 1.2.20.4.1.2. 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. 1.2.20.4.1.3. Equipment repair response time shall be no more than 24 hours. 1.2.20.4.1.4. Service agreement to cover 7 days per week, business hours unless both instruments are down then agreement converts to emergent 24/7. 1.2.20.4.1.5. Preventative maintenance will be performed as frequently as published in manufacturer s operator s manual and within 2 weeks of the scheduled due date. 1.2.20.4.1.6. 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: 1.2.20.4.1.6.1. date and time notified 1.2.20.4.1.6.2. date and time of arrival 1.2.20.4.1.6.3. serial number, type and model number of equipment 1.2.20.4.1.6.4. time spent for repair, and 1.2.20.4.1.6.5. proof of repair that includes documentation of a sample run of quality control verifying acceptable performance. 1.2.20.4.2. Each notification for an emergency repair service call shall be treated as a separate and new service call. 1.2.20.5. 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 CONTRACT; however, it does refer to significant changes in the hardware operational capability. 1.2.20.6. Ancillary support equipment - The Contractor shall provide, install and maintain through the life of the CONTRACT, 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. 1.2.20.7. Interface Requirements 1.2.20.7.1. 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 A). 1.2.20.7.2. 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 Attachment A. 1.2.20.7.3. If a site already has a universal interface box, the Contractor is responsible for everything leading up to the box including any incremental fee required to add additional equipment (e.g. licenses, ports/cards, cables, software, etc.) to the universal interfacing system. 1.2.20.7.4. 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. 1.2.20.7.5. 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. 1.2.20.8. 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. 1.2.20.9. 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. 1.2.20.9.1. The determination and description shall address the following: 1.2.20.9.1.1. Waste toxicity (Reference 40 CFR �261.11 and 40 CFR �261.24) 1.2.20.9.1.2. Waste ignitability (Reference 40 CFR �261.21) 1.2.20.9.1.3. Waste corrosivity (Reference 40 CFR �261.22) 1.2.20.9.1.4. Waste reactivity (Reference 40 CFR �261.23) 1.2.20.9.1.5. Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR �261.31) 1.2.20.9.1.6. Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40 CFR �261.33) 1.2.20.9.1.7. Solid Waste (Reference 40 CFR �261.2) 1.2.20.9.1.8. Exclusions (Reference 40 CFR �261.4) 1.2.20.9.2. 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. 1.2.20.9.3. 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 Contractor response: 1.2.20.9.3.1. Barium (Total) 1.2.20.9.3.2. Cadmium (Total) 1.2.20.9.3.3. Chromium (Total) 1.2.20.9.3.4. Copper (Total) 1.2.20.9.3.5. Cyanide (Total) 1.2.20.9.3.6. Lead (Total) 1.2.20.9.3.7. Mercury (Total) 1.2.20.9.3.8. Nickel (Total) 1.2.20.9.3.9. Silver (Total) 1.2.20.9.3.10. Zinc (Total) 1.2.20.9.3.11. Arsenic (Total) 1.2.20.9.3.12. Selenium (Total) 1.2.20.9.3.13. Tin (Total) 1.2.20.9.3.14. pH 1.2.20.9.3.15. Flash point (to higher than 200 F) 1.2.20.9.3.16. BOD; biochemical oxygen demand 1.2.20.9.4. 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 1.2.20.10. Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 60 days after the award of the CONTRACT. 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 60 day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government. 1.2.20.10.1. Upon award of a CONTRACT, the transition period for the awarded CONTRACT to have all equipment and peripherals installed and operational shall be from date of award through 60 days. During this same period all initial training of VA personnel in the operation and maintenance of said award shall also be completed. 1.2.20.10.2. Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor s submitted plan shall not exceed 60 days for the transition of all services under the awarded CONTRACT 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 CONTRACT for cause under the Termination for Cause clause of the CONTRACT. 1.2.20.10.3. At the end of 60 days from award of the CONTRACT, the awarded Contractor shall have full and sole responsibility for services under the awarded CONTRACT. 1.2.21. 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 CONTRACT] 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 CONTRACT at an effectiveness level of 90% or more. 1.2.21.1. 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. 1.2.21.2. 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.) 1.2.21.3. 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. 1.2.21.4. 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] 1.2.21.5. 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. 1.2.21.6. During the term of the CONTRACT, 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 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] Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the agreement for equipment. 1.2.22. 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. 1.2.23. 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. 1.2.24. 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. 1.2.25. Prior to termination or completion of this CONTRACT, Contractor/subcontractor must not destroy information received from VA, or gathered/created by the Contractor in the course of performing this CONTRACT 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 CONTRACT. 1.2.26. 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 CONTRACT 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 returned to 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 CONTRACT or disposal or return of the IT equipment, whichever is earlier. 1.2.27. 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: 1.2.27.1. Contractor must accept the system without the drive; 1.2.27.2. 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 1.2.27.3. VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase. 1.2.28. 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; 1.2.28.1. 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 1.2.28.2. 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 CONTRACT. 1.2.28.3. 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. NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (29-MAR-2019); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT 877-472-3779 or fbo.support@gsa.gov REGARDING THIS ISSUE.
Web Link: Link To Document
(https://www.fbo.gov/spg/VA/VAAHCS/VAAHCS/36C25719Q0524/listing.html)
Place of Performance: Address: Department of Veterans Affairs;6010 Amarillo Blvd West;Amarillo, TX; Zip Code: 79106; Country: United States
Record: SN05264980-F 20190331/190329230020 (fbodaily.com)
Source: FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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