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FBO DAILY - FEDBIZOPPS ISSUE OF MAY 26, 2018 FBO #6028
DOCUMENT

66 -- Real Time PCR Testing Equipment - VAMC Little Rock, AR - Attachment

Notice Date

5/24/2018
 

Notice Type

Attachment
 

NAICS

334516 — Analytical Laboratory Instrument Manufacturing
 

Contracting Office

Department of Veterans Affairs;Chief, A&MM (90C/NLR);Central Arkansas Veterans HCS;2200 Fort Roots Drive, Bldg 41, Room 224;North Little Rock AR 72114 1706
 

Solicitation Number

36C25618Q9269
 

Response Due

5/29/2018
 

Archive Date

6/28/2018
 

Point of Contact

Sheila D Reed
 

E-Mail Address

7-1053<br
 

Small Business Set-Aside

N/A
 

Description

THIS IS A SOURCES SOUGHT NOTICE ONLY, NOT A SOLICITATION ANNOUNCEMENT AND SHOULD NOT BE CONSIDERED AS SUCH. The Government will not pay for any information received in response to this notice, nor will the Government compensate any respondent for any cost incurred in developing the information provided to the Government. This notice does not constitute a commitment by the Government. Any information provided in response to this market survey will be used for informational purpose only and will not be released. Vendor participation is not a promise of future business with the Government. The purpose of this notice is to conduct market research and obtain information from qualified businesses. Potential sources must demonstrate experience and knowledge of required equipment, services and capability to provide said equipment and service. Potential sources shall submit: Business name, address, point of contact and phone number Business size, any applicable socio-economic category and DUNS number Information for recent/relevant projects similar in nature/size and complexity along with contract number(s) Capability statement and product literature (for brand name (ROCHE) and/or equal item being offered) demonstrating ability to meet all of the requirements listed Any information regarding FSS Schedule contract If you are a distributor, a statement/letter from the manufacturer that your company is an authorized distributor The NAICS Code for this procurement is 334516; business size 1,000 employees. STATEMENT OF WORK For Real Time PCR Testing BPA Language It is the intent of the Department of Veterans Affairs, Central Arkansas Veterans Health Care System (CAVHS), 4300 West 7th Street, Little Rock, AR to establish a Cost-Per-Test (CPT) Blanket Purchase Agreement (BPA) for Automated Real Time Viral Load Polymerase Chain Reaction (PCR) testing for Human Immunodeficiency Virus (HIV-1) Hepatitis C Virus (HCV) and Hepatitis B Virus (HBV). It is the intent of the Government to award A BPA to a single contractor for the molecular testing system and reagents. The BPA shall be under the FSS Contract, FSC Group 66 III, CPT, Clinical Laboratory Analyzers 1.1 PERIOD OF AGREEMENT: This is a single award, firm-fixed price BPA effective July 1, 2018 through June 30, 2019 with 4 one-year options. 2. DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK 2.1 The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined herein. The instrument shall 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). 2.1.1 Equipment shall be acquired for Central Arkansas Veterans Healthcare System clinical laboratory. 2.1.2 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 bottles. 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. 2.1.3 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. Acceptance of substitute products must be mutually agreed upon by the Contractor and Government. All expenses related to the substitute product will be at the expense of the Contractor. 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. 2.3 TEST MENU The estimated quantity of Specific Reagents needed annually: Cobas 6800/8800 HBV - Catalog# 07000979190 Quantity of 15 kits/year (96 tests per kit) Cobas 6800/8800 HCV - Catalog# 06998798190 Quantity of 111 kits/year (96 tests per kit) Cobas 6800/8800 HIV - Catalog# 06998836190 Quantity of 27 kits/year (96 tests per kit) The estimated quantity of Controls needed annually: Cobas HBV/HCV/HIV Control Kit - Catalog# 06998887190 Quantity of 52 kits/year (8 runs/kit) Cobas NHP Negative Control Kit - Catalog# 07002220190 Quantity of 26 kits/year (16 runs/kit) The estimated quantity of General Reagents needed annually: Cobas omni Wash Reagent - Catalog# 06997503190 Quantity of 51 boxes/year Cobas omni Specimen Diluent - Catalog# 06997511190 Quantity of 15 cases/year (4/case) Cobas omni Lysis Reagent - Catalog# 06997538190 Quantity of 13 cases/year (4/case) Cobas omni MGP Reagent - Catalog# 06997546190 Quantity of 31 each/year The estimated quantity of Consumables needed annually: Cobas omni Pipette Tips - Catalog# 05534925001 Quantity of 52 pks/year Cobas omni Processing Plate - Catalog# 05534917001 Quantity of 26 pks/year (32/pk) Cobas omni Amplification Plate - Catalog# 05534941001 Quantity of 13 pks/year (32/pk) Solid Waste Bags - Catalog# 07435967001 Quantity of 1 each/year 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 must meet all of technical specifications of this solicitation. 2.4.3 Automatic software upgrades as available and within two months of release and will at all times maintain compatibility of systems with the existing Laboratory Information System (LIS), especially when contractor software is upgraded. 2.4.4 Operational Features - The instrumentation offered shall have the following: 2.4.4.1 Level sensing to notify operator of short samples. 2.4.4.2 Must provide automated sample extraction and testing on same platform. (Have no manual sample pre-treatment requirements or transfer to testing instrument.) 2.4.4.3 Sufficient capacity and throughput to meet the volume and service demands as defined in the Test Menu. 2.4.4.4 Shall have a built-in (internal system checks) quality control program to regularly monitor performance of vital components. 2.4.4.5 Equipment must maintain, or preferably reduce, the number of work stations or overall labor required to accomplish the required testing in the participating laboratories. 2.4.4.6 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. 2.4.4.7 A 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, refer to details in interfacing requirements section of support features. 2.4.4.7.1 System must support multiple barcode formats (i.e. Code 39, code 128). 2.4.4.7.2 Equipment must accept, at a minimum, a 10 -character alphanumeric (letters and numbers) specimen identifier (20-character flexibility is preferred). 2.4.4.8 Minimal daily and periodic maintenance is preferred. 2.4.4.9 On board tracking of reagent lot calibration. Alerts operator if reagent lot does not have a current valid calibration. 2.4.4.10 Have on board reagent flexibility and/or stability sufficient to accommodate both high and low volume use. 2.4.4.11 At a minimum, single lot number (for each assay) for each quarterly order placed. 2.4.4.12 Data Management System: 2.4.4.12.1 Shall be capable of maintaining all data and if interfaced, retransmit data in the event of normal electrical power interruptions via battery backup. 2.4.4.12.2 Shall possess capability to backup all data to a secondary external storage format (e.g. compact disk). 2.4.5 Technical Features The instrumentation must be approved by the Food and Drug Administration (FDA) and shall have the following: 2.4.5.1 Ability to perform automated Real Time molecular testing for HIV-1, HCV and HBV utilizing proprietary reagents as opposed to third party reagents. 2.4.5.2 HIV-1, HCV, and Hepatitis B DNA PCR testing must be FDA approved for plasma, serum, and plasma/serum, respectively. 2.4.5.3 Linearity ranges will be sufficient to cover clinically relevant ranges, with or without automated dilution. 2.4.5.4 Proposed HIV-1 Real Time PCR viral load reagent kits shall detect Subtype M (Major) with clades A-H and O. 2.4.5.5 Proposed Real Time PCR kits shall meet the following Lower Limit of Detection (LLoD) requirements: HIV-1 LLoD 50 copies/ml HCV LLoD 15 IU/ml HBV LLoD 20 IU/ml 2.4.5.6 Minimum open-vial reagent stability of thirty-six (36) hours. 2.4.5.7 Three levels of assayed controls must be provided. 2.4.5.8. Have minimal Reagent, Quality Control, Linearity preparation, with no reconstitution required. 2.4.5.9 Reagents should be stored at 2-8 °C. 2.4.6 Hardware Features - The instrumentation shall have the following: 2.4.6.1 An on-board, adjustable monitor/screen that is easily readable. 2.4.6.2 A printer that has the capability of printing a patient report with patient demographic information that includes minimally the patient s name and accession or unique identifier number (UID). 2.4.6.3 An uninterruptible power supply for each instrument provided under this BPA. 2.4.6.4 A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory 2.4.7 Method Performance/Comparison will be at the expense of the Vendor, will include linearity material and reagents, and be consistent with current CLSI and related documents, CAP Standards and Federal Regulations, for the following: 2.4.7.1Accuracy studies for each analyte/assay. A minimum of 40 samples for each assay be run by the present and the proposed method. These samples shall encompass the reportable range (AMR), samples selected must span the full reportable range. In addition, a minimum of 10 samples with results not detected by the present method for each assay should also be performed by the proposed method. Vendor will analyze results and provide statistical data to support acceptance of the new method. The evaluation will include validation of accuracy and result concordance as compared to current method as well as meet current standards defined by CLSI. Note: If correlation studies demonstrate a significant bias/ difference, baselines must be re-established for all patients on anti-viral therapy for that test. Re-establishing baselines will be at contractor expense. 2.4.7.2 Analytical Measurement Range (AMR) Validation will be performed on proposed instrument(s) for each assay to validate the reportable range as recommended by the manufacturer. The material must have values, which are near the low, mid, and high values of the AMR and be appropriate matrix for the clinical specimens assayed by that method. A 5-point linearity analysis that adheres to the Beer-Lambert law and spans the entire range shall be performed as a minimum. 2.4.7.3 Precision study All 3 levels of the control material will be used. This will consist of a within run precision study of 10 of each level of control as well as a day-to-day precision study of said controls (may be run twice a day) for a total of 20 values per level of control. Within run precision should also be performed on 20 patient samples for each test. 2.4.7.4 Calibration verification will be performed using samples of known value. These can be calibrators or CAP assayed survey samples, or equivalent, as required. Manufacturer s published recommendations should be followed. 2.4.7.5 Sensitivity. Sensitivity may be validated concurrently with the linearity verifications. 2.4.7.6 Specificity Studies. This will determine whether or not there are adverse affects for increased bilirubin, hemolysis, lipemia, or other interfering. substances. 2.4.7.7 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 program(s) shall be provided to each laboratory at no charge. This will validate the instrument(s)/assay(s) is not subject to carryover. 2.4.9 Support Features 2.4.9.1 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. 2.4.9.2 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/validate instruments for operation for performance of acceptance testing. The Contractor shall assist the Government with validation and method comparison studies. All materials and reagents needed for such correlation at no cost to the Government. The Contractor shall perform all of the statistical analysis and report data in an organized, clearly comprehensible format. This process shall be completed within two weeks of installation of the analyzer at each site and shall be consistent with current CLSI and related documents, CAP Standards and Federal Regulations. 2.4.9.3 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 Cost Per Reportable Result 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, ground transportation, room and board for each participant. 2.4.9.4 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: 2.4.9.4.1 A technical assistance center must be available by telephone 24 hours per day, 7 days per week with a maximum call back response time of one (1) hour. 2.4.9.4.2 Equipment repair service must be provided during core business hours Monday through Friday, 8am to 5 pm Central Standard Time. 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. 2.4.9.4.3 On-site Equipment response time shall be no more than 24 hours. 2.4.9.4.4 Preventative maintenance will be performed as frequently as published in manufacturer s operator s manual and within 2 weeks of the scheduled due date. 2.4.9.4.5 A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following: 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. 2.4.9.4.6 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 designated representative of the Government 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. Each instrument provided by the contractor shall maintain an uptime of 90% in each month of the term of the agreement. 2.4.9.4.7 Each notification for an emergency repair service call shall be treated as a separate and new service call. 2.4.9.5 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 must 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. latest 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 upgrade 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. 2.4.9.6 Ancillary support equipment - The Contractor shall provide, install and maintain 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. An Uninterruptible Power Supply (UPS), with a built-in line conditioner, capable of supporting the full scope of equipment operation for each proposed analyzer shall be provided. In addition, the vendor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, tables/stands, etc. 2.4.9.7 Interfacing Requirements- The Contractor shall be responsible for providing all hardware required for the connection, implementation and operation of the interface to the universal interface and any incremental fee that is required each time an instrument is added to an existing universal interface system (see requirements below). Laboratory instrumentation will be placed on the Medical Virtual Local Area Network (VLAN) which will preclude information from leaving VA. 2.4.9.7.1 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 shall 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 the chart below. 2.4.9.7.2 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. 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 software licenses and equipment needed to connect and successfully interface with VA computerized hospital information systems. 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. Currently, the CAVHS is operating with Data Innovations Instrument Manager. It is estimated that additional costs to the Contractor to increase instrument interface capacity shall be as follows: 2.4.9.7.3 Data Innovations - $2,500 per each individual interfaced instrument (based on facility s requirements). This price includes a connection license to the existing Instrument Manager and 24 hours, 7 days per week technical support and maintenance. 2.4.9.8 Commercial offerings - The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and shall assist in regulatory compliance, e.g. PC computer diskette of their procedure manual or an on-line procedure manual in the instrument software. 2.4.9.9 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. 2.4.9.9.1 The determination and description shall address the following: Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24) Waste ignitability (Reference 40 CFR §261.21) Waste corrosivity (Reference 40 CFR §261.22) Waste reactivity (Reference 40 CFR §261.23) Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR §261.31) Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40 CFR §261.33) Solid Waste (Reference 40 CFR §261.2) Exclusions (Reference 40 CFR §261.4) 2.4.9.9.2 The contractor shalll 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. 2.4.9.9.3 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 vendor response: Barium (Total) Cadmium (Total) Chromium (Total) Copper (Total) Cyanide (Total) Lead (Total) Mercury (Total) Nickel (Total) Silver (Total) Zinc (Total) Arsenic (Total) Selenium (Total) Tin (Total) pH Flash point (to higher than 200 F) BOD (biochemical oxygen demand) 2.4.9.9.4 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 2.4.12 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. 2.4.12.1 The vendor/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 vendor/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. END OF SOW Responses to this notice shall be emailed to Sheila Reed at Sheila.reed@va.gov. Include the following in the email subject line: RFI - Real time PCR Testing Company s Name. Responses must be received by 3:00pm (central) Tuesday, May 29, 2018. This notice is to assist in determining sources only. There is no solicitation currently available. There is no guarantee, expressed or implicit, that the market research for this acquisition will result in a particular set-aside, sole source award or any other guarantee of award strategy. All information is to be provided on a voluntary basis and at no charge to the Government.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/VACAHCS598/VACAHCS598/36C25618Q9269/listing.html)
 

Document(s)

Attachment
 

File Name: 36C25618Q9269 36C25618Q9269.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4333577&FileName=36C25618Q9269-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4333577&FileName=36C25618Q9269-000.docx

 

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

Record

SN04933375-W 20180526/180524230424-f2ed62d5ff4bbf2f65fafdd6026d5edd (fbodaily.com)
 

Source

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

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