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FBO DAILY - FEDBIZOPPS ISSUE OF DECEMBER 16, 2017 FBO #5867
DOCUMENT

66 -- WTX Coagulation Analyzer CPT - Attachment

Notice Date

12/14/2017
 

Notice Type

Attachment
 

NAICS

339112 — Surgical and Medical 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

36C25718Q0241
 

Response Due

12/21/2017
 

Archive Date

2/19/2018
 

Point of Contact

Phil Campos
 

Small Business Set-Aside

N/A
 

Description

The West Texas VA Health Care System (WTVAHCS) is seeking Service Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB) or Small Business (SB) sources capable of meeting the requirement listed below. The acquisition will be accomplished using commercial item procedures in accordance with FAR Part 13. 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 339112. Any SDVOSB, VOSB or Small Business firms who wish to identify their interests and capability to provide this service must provide information by notifying the Contract Specialist no later than NOON PM Central Time, December 21, 2017. Notification shall be e-mailed to Phil Campos phil.campos@va.gov. DISCLAIMER This Source 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: STATEMENT OF WORK for COAGULATION ANALYZER The West Texas Veterans Affairs Health Care System (WTVAHCS) Department of Pathology & Laboratory Service requires a Coagulation testing reagent rental (cost per test) business model for processing and analyzing in-house coagulation assays. The vendor shall provide, in accordance with all applicable federal, state and local regulations, laws, and ordinances, and in accordance with the specifications outlined for accreditation certification if applicable, equipment and supplies as negotiated on GSA contracts to enable WTVAHCS too accurately and efficiently analyze patient specimens. The vendor shall provide support and services to include the performance of analytical testing as defined by the vendors published FDA approved parameters. All requirements and provisions defined in the specification of this solicitation will apply to any vendor, i.e., branch, division, sub-Vendor, etc. supplying parts or reagents on behalf of the vendor. INTENT- VENDOR RESPONSBILITIES: Shall provide an instrument capable of efficiently processing approximately 4,200 coagulation tests per annum at the Big spring Laboratory. The instrument will be rented by the Big Spring WTVAHCS at a reduced rate in exchange for a reagent purchase agreement. The associated costs will include (a) equipment use, (b) all reagents, standards, 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, (c) training for Government personnel. Delivery, installation, and removal of equipment is provided at no additional charge. GENERAL REQUIREMENTS Contractor shall provide all labor, material, maintenance, tools, equipment, technical/maintenance manuals, training, travel, delivery, and accessories necessary to furnish the equipment defined herein. The contract proposal will include the equipment, preventative maintenance, and service. It will also include all reagents, supplies, consumables, (other than ink and paper), assay controls, calibrators, and parts necessary for the performance of complete performance of tests listed below. REQUIRED: Tests Estimated Annual Volume (does not include calibrations/ controls) PT 3000 PTT 1000 D-Dimer 200 B. Shall provide a price for reagent rental. The price shall include costs covering (a) all reagents, standards, controls, supplies, consumable/disposable items, (b)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 does not include those items approved for exclusion by the government such as printer paper, labels etc. This per patient reportable result price will also encompass all costs associated with dilution, repeat and confirmatory testing required to produce a single patient reportable result. It will 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 National Committee for Clinical Laboratory Standards (NCCLS). (c) All necessary maintenance to keep the equipment in good operating condition (this element includes both preventive maintenance and emergency repairs) and (d) training for Government personnel. Delivery, installation, and removal of equipment is provided at no additional charge. C. Maintenance and Repair: WTVAHCS will be responsible for any daily routine maintenance. D. Billings: rental shall be monthly, reagents are purchased as needed. E. Terms and conditions of Installation: The WTVAHCS shall prepare the site at its own expense and in accordance with the specifications furnished by the vendor. Vendor will provide installation, start-up assistance and operator instructions and two operator/maintenance manuals. Installation will be completed as soon as practicable after delivery during normal working hours. The performance period shall commence on the date of the installation. 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 - 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 producing 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. 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. EQUIPMENT REQUIREMENTS 1. Specifications of component equipment as set forth in this section are minimum specifications, unless otherwise stated, and shall not be construed as limiting the overall quality, quantity or performance characteristics of items furnished in the system. The Contractor Furnished Equipment (CFE) shall meet or exceed the minimum requirements and shall be held responsible for the supply, performance and overall quality of the contractor s furnished equipment. 2. All equipment to be supplied under this specification shall be the newest and the most current model of a standard product of a manufacturer of record. A manufacturer of record shall be defined as a company whose main occupation is the manufacture for sale of the items of equipment and which: a) Maintains a factory production line. b) Maintains a stock of replacement parts for the item. c) Maintains engineering drawings, specifications, operating manuals and maintenance manuals. d) Has published and distributed descriptive literature and equipment specifications on the equipment. 3. Automated coagulation equipment must meet the following specifications: The vendor will provide the facility with Food and Drug Administration (FDA) approved analyzer/equipment, software, reagents, controls, calibration materials, disposables, and any consumable parts necessary for analyzing/testing. Tests shall be vendor supported. The analyzer must be able to perform all assays listed above. Equipment shall have accurate capability of monitoring reagent usage. The vendor shall provide/install any routine and special items required to operate/maintain the equipment/analyzer in optimal condition such as but not limited to: printers, UPS, interface boxes and surge suppressors. Any items excluded by the vendor shall be delineated in their technical proposal. The cost of the excluded items shall be incorporated in the price proposal. Must meet performance and characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI). Bi-directional, bar coded computer interface. The fully operational interface (both hardware and software) must be immediately available for implementation to the VA Vista hospital information system. Interfacing requirements to be provided by the vendor: Instrument LIS physical connection and translation (drivers). Must be compatible with Data Innovations and VISTA Any additional hardware and software needed to interface the analyzer and technical assistance with interfacing the analyzer The total equipment footprint, when installed, must not negatively impact the functionality/ operations of the Pathology & Laboratory Service nor will it require significant and/or costly infrastructure changes. (The department counter tops are modular and can be adapted without constituting a major infrastructure change.) Printer with capability of printing a chartable patient report. Uninterruptible power supply for each analyzer. Analyzer shall have diluting capability with the analyzer calculating the final result. System shall have positive sample identification to reduce possible sources of error/delay and to improve laboratory efficiency. System shall have a design that removes the possibility of reagent or sample carryover. Carryover studies shall be performed, as applicable, as part of the initial evaluation of the instrument. Vendor shall provide interpretation of the raw data as part the install. Vendor shall also provide documented evidence confirming the system design removes the possibility of any reagent or sample carryover. System must have documented evidence that there is no reagent carryover interference with other onboard assays. Contractor shall provide quality control material at a minimum of two levels; normal and elevated/abnormal levels. 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 BPA will convert to the new yearly lot number within 2 months of each other. 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: Furnish assayed control plasmas to be run concurrently until a range can be established for the unassayed material. Provide documented peer review of unassayed control data. The product information must specify an appropriate ISI for the instrument and reagent lot number combination. 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. Documentation must be provided regarding the effect of lupus anticoagulants in the therapeutic monitoring of warfarin. Interference of heparin in the PT reagent must be minimal. The analyzers must have a comprehensive QC Program which includes at a minimum the following options: QC files with automatic calculations of mean and standard deviation of individual lots with data storage. The ability to view and print daily and monthly QC results The ability to view and print Levy Jennings graphs On-line documentation of out of range QC QC acceptance criteria built in Equipment shall be able to store and retransmit records (24 hours of maximal instrument throughput) in case of interface downtime. Must have ability to backup and store patient data on external media. Vendor shall list the reagents and calibrators that require any additional preparation prior to use such as warming/mixing/reconstitution. 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. Vendor shall list the reagents/waste receptacles requiring treatment before disposal. Vendor shall also list all reagents/waste that is considered above normal toxicity and/or hazard. Vendor cannot be including remotely monitored maintenance/troubleshooting software program that electronically transmits critical operational and administrative information from instruments to our internal systems via a secure Internet connection.   This secure, encrypted technology will enable transfer of key logs, report generation, and remote services developments. It should also offer the potential to improve inventory management by enhanced troubleshooting information made available to a technical support group, a portal to access instrument logs, files, maintenance information, software version, proactive instrument operations monitoring, predictive instrument maintenance, and QC data collection for peer review. 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. Licensing and Accreditation The Vendor shall have all licenses, permits, accreditation and certificates required by law and or regulatory compliance. Personnel assigned by the Vendor to perform these services covered under this contract shall be licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. INSTALLATION AND VALIDATION Throughout the life of the agreement, the vendor shall provide assistance to the user in setting up and maintaining/trouble shooting user-defined assays as additional tests are brought in-house. 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. 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. Reportable Range Requirements- PT, aPTT, Fibrinogen, D-Dimer, and heparin assays Contractor shall provide accurate high and low reportable range limits for all clotting assays (i.e., PT, aPTT and), particle agglutination (immunological) assays (i.e., D-dimer) TRAINING & SUPPORT 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. 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. SERVICE AND MAINTENANCE Instrument support service shall provide assistance with troubleshooting and repair of the analyzers. On-site service shall be available Monday through Friday during regular business hours (8am-5pm). The support service shall follow-up all down time calls within 1 hour. The vendor shall provide a twenty-four hour/seven-day service hotline with technical support. The vendor shall provide a preventative maintenance schedule to include timely scheduled vendor preventative maintenance visits as required. The vendor shall supply engineering controls if necessary for any heat, humidity, or noise issues that may result from use of the proposed system. Vendor shall provide standard and routine software and hardware upgrades to the equipment hardware and operating systems, without additional charge to the Government (e.g. upgrades that correct or improve either the mechanical operations or software of the system and would keep the instrument performing optimally). Vendor shall define daily, weekly, monthly, and as needed maintenance and the time required to perform each maintenance task. Vendor shall indicate which tasks are user level and which are service level. For reagents with hazardous constituents, vendor shall provide a mechanism for the Laboratory to meet local discharge requirements. The vendor shall supply information regarding any hazardous chemicals OTHER Request for instrumentation upgrades or replacement due to workload increase, excessive instrumentation failures/malfunctions, breakdowns, or service calls shall be evaluated as needed/annually by the laboratory with communication to the vendor for modification of the contract. A high incidence of such problems with any equipment/analyzer supplied may indicate probable non-compliance with the terms of this contract and will entitle the facility/clinic to its replacement with another analyzer(s) that can produce the required criteria satisfactorily to the user. The vendor shall remove all equipment within 90 days after notification of the expiration of the terms of this agreement but not until the completion of new vendor's equipment installation inclusive of completed cross over studies. Vendor shall be responsible for removing the hard drive and turning it over to the VA for destruction prior to removal of any analyzer. The vendor shall reimburse the facility for any costs/supplies related to tests sent to a referral laboratory when testing is not available through no fault of the facility due to reagent problems, other product issues, or other vendor related factors. The assessed damages shall be applied to the invoice in the form of a credit or deduction. In the event that the any consumable, reagent, or other necessary item are found to be defective and unsuitable for use with the vendor's equipment, or the contractor has failed to comply with the requirements for routine supply delivery, the contractor shall deliver the consumable supplies within a period of 24 hours after receipt of the verbal order for priority delivery from the facility. If either circumstance has occurred, the vendor shall deliver to the facility, in the most expeditious manner possible, without additional cost to the facility, the necessary consumables in sufficient quantity so testing is not delayed. 2.4.20.9. 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. 2.4.20.9.1. The determination and description shall address the following: 2.4.20.9.1.1. Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24) 2.4.20.9.1.2. Waste ignitability (Reference 40 CFR §261.21) 2.4.20.9.1.3. Waste corrosivity (Reference 40 CFR §261.22) 2.4.20.9.1.4. Waste reactivity (Reference 40 CFR §261.23) 2.4.20.9.1.5. Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR §261.31) 2.4.20.9.1.6. Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40 CFR §261.33) 2.4.20.9.1.7. Solid Waste (Reference 40 CFR §261.2) 2.4.20.9.1.8. Exclusions (Reference 40 CFR §261.4) 2.4.20.9.2. 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. 2.4.20.9.3. 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: 2.4.20.9.3.1. Barium (Total) 2.4.20.9.3.2. Cadmium (Total) 2.4.20.9.3.3. Chromium (Total) 2.4.20.9.3.4. Copper (Total) 2.4.20.9.3.5. Cyanide (Total) 2.4.20.9.3.6. Lead (Total) 2.4.20.9.3.7. Mercury (Total) 2.4.20.9.3.8. Nickel (Total) 2.4.20.9.3.9. Silver (Total) 2.4.20.9.3.10. Zinc (Total) 2.4.20.9.3.11. Arsenic (Total) 2.4.20.9.3.12. Selenium (Total) 2.4.20.9.3.13. Tin (Total) 2.4.20.9.3.14. pH 2.4.20.9.3.15. Flash point (to higher than 200 F) 2.4.20.9.3.16. BOD; biochemical oxygen demand 2.4.20.9.4. 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 INTERFACE Transfer of data is bidirectional and will occur in the following manner: INSTRUMENT DATA INNOVATIONS VISTA (LIS) The following data fields will be collected: Prime ID Specimen ID Patient ID Priority Action code Sample type Collect date Collect time Creation date Creation time Last name First name Middle name Sex Birthday Location Analyzer Station Test name Data is transferred from VISTA to a Data Innovations Secure Network Interface (SNI) device which is then sent to the instrument, using the appropriate format. Once testing is complete, the instrument sends the result back to the SNI which then sends the result back to VISTA in the appropriate format. All testing is performed by Pathology & Laboratory Medicine Service staff using appropriate procedures, access and verify codes. VA sensitive information is stored in the VISTA/LIS database and all records are backed up on disk and stored in a secure, location, (disks in locked drawers behind locked doors) per regulations. Data will be available to providers using CPRS system. The above ppi will stay on the instrument s hard drive for about one month and then will be written over by new patient data. At the end of the contract the hard drive and any other data storing devices will be removed from the instrument and be taken to IRM for disposal.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/VAAHCS/VAAHCS/36C25718Q0241/listing.html)
 

Document(s)

Attachment
 

File Name: 36C25718Q0241 36C25718Q0241.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3965416&FileName=36C25718Q0241-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3965416&FileName=36C25718Q0241-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Place of Performance

Address: Department of Veterans Affairs;300 Veteran Blvd;Big Spring, Texas

Zip Code: 79720
 

Record

SN04767273-W 20171216/171214231225-daf61e01b25004f0b84136881e4fcc02 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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