Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF JANUARY 11, 2020 SAM #6617
SOLICITATION NOTICE

65 -- Specialty Immunoassay

Notice Date

1/9/2020 12:45:08 PM
 

Notice Type

Presolicitation
 

NAICS

325413 — In-Vitro Diagnostic Substance Manufacturing
 

Contracting Office

244-NETWORK CONTRACT OFFICE 4 (36C244) PITTSBURGH PA 15215 USA
 

ZIP Code

15215
 

Solicitation Number

36C24420Q0213
 

Response Due

1/16/2020 8:59:59 PM
 

Archive Date

02/15/2020
 

Point of Contact

Jami CadeContract Specialist5627662222
 

E-Mail Address

Jami.Cade@va.gov
(Jami.Cade@va.gov)
 

Awardee

null
 

Description

DISCLAIMER This Sources sought is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201(e), 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 sources sought. If you can provide the services as described in the below scope of work description please respond by Thursday January 16th, at 3:00PM EST to jami.cade@va.gov with the following information: Company Name Socio Economic Status: I.E. Small Business, Service Disabled Veteran Owned, Veteran owned, Women Owned, etc Email Address Phone Number Physical Address Capability statement pertaining to Scope of Work Limitations on Subcontracting will apply to the resulting solicitation. DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK Introduction and Scope of Work: The Chemistry section of Pathology and Laboratory Medicine located at the Crescenz VA Medical Center in Philadelphia, PA provides laboratory testing for the serologic and virologic diagnosis of infectious diseases to any VA facility wishing to utilize its services. The tests offered are those that are too complex (e.g. complement fixation testing) or are not cost effective (e.g. Lymes, Measles, Mumps, Rubella, Syphilis, VZV) at the local level. The Special Reference Lab performs several Chemiluminescent Immunoassay (CLIA) tests on the DiaSorin Liaison, a random access, continuous feed analyzer. As the contract on this instrument will expire February 29, 2020, the Chemistry Lab needs to request a bid for replacement of this contract with a new base year plus four option year contracts. PRICES AND TERMS: Pricing shall be based on the average yearly test volume per instrument/analyzer. This agreement will be a Cost per Reportable Contract. (Cost per reportable result). The Government estimates the volumes listed but does not guarantee volumes as listed; they are ESTIMATES ONLY. TERM OF AGREEMENT: The agreement shall be effective for one base year and 4 renewable option years. ORDERING METHOD: The Crescenz VA Medical Center, (CMCVAMC) will order products via telephone, facsimile or other written communication, identifying the products by number, quantity, address for delivery, and any special instructions. The following personnel are authorized to telephone, fax, or e-mail orders: Supervisory Medical Technologist Rosemary E. Millili, MT (ASCP Other Medical Technologists, as designated DELIVERY TICKETS: Unless otherwise agreed to, all deliveries under this agreement shall be accompanied by delivery tickets or sales slips that shall contain the following information as a minimum: a. Name of contractor b. Contract number c. Model number or National Stock Number (NSN) d. Purchase order number e. Date of purchase f. Quantity, unit price and extension of each item (unit prices and extensions need not be shown when incompatible with the use of automated systems, provided that the invoice is itemized to show information) g. Date of shipment. INVOICES AND PAYMENTS: The Contractor shall invoice each delivery order as directed by the ordering activity. Payments will be made by the VA Finance Center, Austin, Texas, or by Purchase Card, if applicable. INVENTORY AND SUPPLIES: Shall be in accordance with National FSS Statement of Work. a. Delivery of supplies: Shall be in accordance with Statement of Work. Any unexpected changes in methodology/technology shall be at the expense of the Contractor. b. Alert/Notification of delays in shipments as well as all technical advisory/recalls/alerts, prior to or simultaneously with field alerts shall be forwarded to the Chemistry Lab (CHEM) Supervisor, Chief technologist, and the Lead Technologist (Currently Vacant). c. Special handling for emergency orders of supplies: In the event that the consumables 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 routing supply delivery, the contractor is required to deliver the consumable supplies within 24 hours of receipt of a verbal order for priority delivery from the government activity. If either circumstance has occurred, the contractor will deliver to the government site in the most expeditious manner possible without additional cost to the government GENERAL REQUIREMENTS (APPLICABLE TO ALL EQUIPMENT): a. In order to perform the tests in a timely manner, the contractor must provide a fully automated, random access, continuous feed analyzer. To maximize incubator efficiency, test cuvettes must be individual, not linked together. b. The equipment includes an automated processor and reader. The system must have an FDA cleared 25 hydroxy Vitamin D assay, Lyme combined IgG & IgM screening test, Measles (Rubeola) Assay, Mumps Assay, Rubella Assay, Syphilis Screening assay, Varicella Zoster (VZV) Assay and Quantiferon TB Gold plus. c. The system must be pre-programmed and bi-directionally interfaceable. The contractor will provide the training necessary for technologists who will run the instrument. The system must be fully automated to handle bar-coded specimens from the beginning of the test until results are transmitted across the interface. The system needs to have a throughput enough to allow the Chemistry Lab to perform the testing within the time constraints of a forty-hour workweek. Training: The Contractor shall provide training at the time of installation to include training on the operation of the system, data manipulation, preventative maintenance and basic trouble shooting and repair. A training or competency checklist shall be provided by the Contractor. Site Preparation: Site preparation specifications shall be furnished in writing by the Contractor as a part of the equipment proposal. These specifications shall be in such detail as to ensure that the equipment to be installed shall operate efficiently and conform to the manufacturer s claimed specifications. The Contractor shall be responsible for assessing the space available in the facility in order to ensure the right size equipment is provided; thereby not creating a safety hazard. Implementation and Transition: The Contractor shall provide with its quotation a transitioning plan for the complete transition of all services under the awarded agreement including installation, training of personnel, transition of all testing materials, reagents and supplies, etc., and performance of all correlations and validations. This transition shall be completed no later than 60 days after the award of the agreement. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. Delivery: The analyzer and all reagents will be delivered to the Crescenz VA Medical Center (CMCVAMC) Philadelphia using the address below: 3900 Woodland Ave (3B134) Pathology and Laboratory Medicine (113) Chemistry Philadelphia, PA 19104 Comparison and Validation of Analyzer: The Contractor shall assist, to the satisfaction of the Government, at no cost to the Government, all comparison and validation studies to include any materials and reagents needed for such correlation. The Contractor shall perform all the statistical analyses and report data in an organized, clearly comprehensible format. This process shall be completed within 30 days of installation of the analyzer and shall be consistent with current CLSI (formerly NCCLS) and related documents, CAP Standards and Federal Regulations. CLSI Procedure Manual: The vendor shall provide a copy of operating procedures in Clinical and Laboratory Standards Institute (CLSI) digital format at time of installation using software compatible with VA (Microsoft Office WORD). Progress and Compliance: The system must perform assays as advertised 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). EVALUATION METHODOLOGY: The Government intends to award this contract based on lowest price technically acceptable. The Government intends to award one Firm Fixed Price requirement contract to the responsible offeror submitting proposals that are determined to be lowest price technically acceptable. Lowest Price, Technically Acceptable (LPTA) means that the award will be made to the offeror whose price is lowest among all proposals that were deemed to be technically acceptable. Technical acceptability will be measured minimally by: a) The offerors ability to meet desired turnaround times and instrument capabilities as stated in the statement of work. b) Past performance references. The solicitation specifies the technical requirements that Crescenz VA Medical Center (CMCVAMC) has established above in the detailed statement of work (SOW) the award will be made based on the lowest aggregate price of proposals meeting or exceeding the acceptability standards for non-cost factors in accordance with FAR 15.101-2(b)(1)). SCOPE OF PROCUREMENT: The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the statement of work. The instrument shall have random access capability (if discrete testing is required) and be able to able to simultaneously perform the complete profile as described below meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI). ORDERING METHOD: The participating facility may order products via Electronic Data Interchange (EDI), telephone, facsimile or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions. Equipment must maintain, or preferably reduce the number of work stations or overall labor required to accomplish the required testing by each laboratory. If Contractor offers a family of analyzers, Michael J. Crescenz VAMC technical evaluation panel will determine if instrumentation proposed meets needs of using facility. Equipment shall be acquired for Michael J. Crescenz VAMC. Equipment must meet the volume and turnaround time requirements of Michael J. Crescenz VAMC Lab. The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Sigma performance may be included to support test quality. Expiration date must be clearly marked on reagent, standards and control containers. Unexpected changes in methodology/technology shall be at the expense of the Contractor. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals determined at contract award. The Contractor shall provide a copy of all relevant permits/licenses and certifications inclusive of any sanctions current or pending throughout the United States of America in the proposal. Special handling for emergency orders of supplies: In the event that the supplies are found to be defective and unsuitable for use with the Contractor s equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor s equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery. DEFINITIONS: Cost per Patient Reportable Result (CPRR)- aCost-Per-Test Clinical Laboratory Analyzers - Contractors are required to provide a price for a reportable patient result. The per patient reportable result price shall include costs covering: (1) installation of new equipment and equipment use for the entire contract period, (2) all reagents, standards or calibrators, quality controls, supplies, consumable/disposable items to include but not limited to printer paper, Printer maintenance kits, printer cartridges, parts, accessories (including replacement of printers as they fail) and any other item required for the proper operation of the Contractor s equipment and maintenance of these systems and anything 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 both off-site and on-site. Contractors shall provide delivery, installation and removal of equipment at no additional charge. Cost per Test (CPT) - , 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) equipment use for the life of the contract, (2) all reagents, standards/ calibrators, quality controls, supplies, consumable/disposable items, paper, parts, accessories (including replacement of printers as they fail) and any other item required for the proper operation of the Contractor s equipment including water supply systems and maintenance of these systems and anything 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 both off-site and on-site. Contractors are required to provide delivery, installation and removal of equipment at no additional charge. TEST MENU: Refer to Attachment A for desired test menu and estimated annual volumes. GENERAL REQUIREMENTS: Specialty Immunochemistry Primary analyzer(s) Base equipment offered that shall fully support the scope of operations (minimal requirements). Operational Features- The instrumentation offered shall have the following: The capability of performing analysis on 100% of the tests listed in Attachment A. Sufficient capacity and throughput to meet the volume/ service demands as defined in Attachment A. Safety features to avoid unnecessary exposure to biohazardous and chemical material. The exposure to and the volume of biohazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling. Contractor must provide a mechanism for the Clinical Laboratory to meet local discharge requirements (i.e. mercury and formaldehyde SDS sheets must be provided in advance for review). A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system. The accuracy of the barcode reading must have less than a 1% failure rate. Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently. Equipment must accept, at a minimum, BCBC characters in specimen identifier that is all alpha. Ability to prioritize STAT testing without compromising existing programmed testing. Menu flexibility to accommodate batch testing. Minimal daily, monthly, and periodic maintenance. Ability to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage. On board reagent stability sufficient to accommodate both high and low volume use. Contractor to provide expiration dates of at least six (6) months for reagents when available. Capability to detect out of range quality control and flag patient results if the quality control is out of range. Ability to accept various types of sample containers. Must have accurate metering capability for monitoring reagent usage or accept DVAMC s monthly LMIP statistics generated from VistA computer system. Technical Features- The instrumentation must be approved by the Food and Drug Administration (FDA) and shall have the following: On-board QC data management system with a minimum storage capacity of fifteen QC files and includes Levy-Jennings graphs. Analyzer must have the ability to capture, store and electronically transfer QC data. Ability to monitor instrument performance, preferably using a secure, direct data connection to a technical support center so instrument performance can be managed in real time. On board reagent inventory system. No carryover with on board disposable pipettes. Minimal reagent preparation, preferably no reconstitution required. Accept serum, plasma, and other body fluids. Antigen excess checks (immunochemistry). Ability to run replicate testing with one sample. Ability to change reagents while instrument is in operation. Onboard calibration and lot (calibrator and reagent) tracking. Long calibration stability. Minimal specimen volume. Adequacy of sample detection. Equipment performance evaluations will be based on at least the following: 2.4.4.15.1 Quality and accuracy of testing, 2.4.4.15.2 Amount of downtime of each analyzer, 2.4.4.15.3 Competence of service personnel, and 2.4.4.15.4 Number of times the service engineer has to return to fix the same instrument issue Other performance categories can be added or removed as needed. Hardware Features- The instrumentation shall have the following: A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory. An on-board monitor/screen that is easily readable. A printer that has the capability of printing a patient report with patient demographic information that includes minimally the patient s name and accession or unique identifier number (UID). An uninterruptible power supply with line conditioner for each instrument provided. Primary tube sampling. Clot detection. A quality control user group comparison capability with peers. Specific Equipment Requirements Require Improved CLIA technology to provide higher throughput and increased sensitivity for lower analytic concentrations. Require a fully automated analyzer able to run multiple tests at one time for improved patient result turnaround times. The selected vendor must provide computer software that can track QC trends and full traceability for QC, patient results, reagents, and calibration curves along with calculate any final test results based on the proper algorithm for the final reported result. The selected vendor must be able to hold up to 25 reagents onboard at the same time and has a database backup which retains both patient and QC data. Must include yearly service contract to include Preventive Maintenance and instrument malfunction repairs. Method Performance/Validation Requirements 1. Method performance/comparison shall be at the expense of the Contractor, shall include linearity material and reagents, and be consistent with current CLSI guidelines and related documents, College of American Pathologists (CAP) standards and Federal regulations. 2. Correlation studies for each analyte: A minimum of 40 samples spanning the reportable range shall be run by the present and the proposed method. In systems where multiple sampling modes exist, mode to mode correlation studies must also be performed. Contractor shall analyze results and provide statistical data to support acceptance of the new method for above studies. Statistics shall consist of at least mean, bias, slope, y-intercept, correlation coefficient, ROC analysis, and meet current standards defined by CLSI. 3. Analytical Measurement Range (AMR) Validation shall be performed on proposed instrument(s) for each analyte to validate the reportable range where applicable (not on Qualitative tests). 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. 4. 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. 5. Sensitivity. Sensitivity may be validated concurrently with correlation studies. Mathematical calculations to determine efficiency, sensitivity, false positive rate and false negative rate are applied. 6. Specificity Studies. A review of product literature and assay inserts to determine any adverse effects for increased bilirubin, hemolysis, lipemia, or other interfering substances. 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 programs shall be provided to the Michael J Crescenz VA Laboratory at no charge. Reference Range- A reference range must be determined for each test following CLSI/regulatory guidelines. Samples used for the reference range study must be representative of the patient population being tested. Reference range assessment must be performed for each lab. One of the following protocols shall be used: A verification of the manufacturer s suggested reference range may be performed as long as the suggested range is based on a comparable population of test subjects. The manufacturer shall provide specific information defining how the suggested range was determined. A minimum of 50 reference individuals shall be used to verify the manufacturer s range. Any apparent outliers should be discarded and new specimens obtained to provide a statistically valid verification. If the suggested manufacturer s range is not appropriate for the patient population, a reference range shall be established. Establishing a reference must follow CLSI guidelines. This requires a minimum of 120 reference individuals to be used to establish a reference range. The reference interval should be determined using the nonparametric method. If a laboratory is currently using the proposed instrument/reagent system, the in-use reference range can be transferred to the new system if a method comparison study between the two systems proves to be acceptable. If comparison studies are not acceptable, one of the two above items must be performed. 2.4.9 Ordering/Billing: Orders will be placed by individual DVMAC via I.M.P.A.C. purchase card or purchase order via telephone, mail, fax, or online. Billing will be monthly in arrears for the level of tests by each facility. Monthly payments include all equipment, service, reagents, calibrators, controls and parts necessary to perform tests provided to the contractor. Deliveries will be F.O.B. destination. 2.4.9.2 Contractor performance evaluations will be based on at least the following: 2.4.9.3.1 Timeliness and accuracy of invoicing, Other performance categories can be added or removed as needed. Support Features- Commercial marketing. The equipment models being offered shall be in current production as of the date this offer is submitted. For purposes of this solicitation, current production shall mean that the clinical laboratory analyzer model is being offered as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable. Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other item included and any other items that is required to establish instruments for operation for performance of acceptance testing. The Contractor shall perform, to the satisfaction of the Government, all validation studies including: precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specificity at no cost to the Government. The Contractor shall perform all of the statistical analysis as stated in the Method Performance/Validation section above and report data in an organized, clearly comprehensible format. Training. The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of Michael J. Crescenz VAMC laboratory services. 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 2 operators the first year of the contract and 1 operator per year at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant. The Contractor shall provide all necessary procedures manuals, troubleshooting manuals, operator manuals (also available on computer disc format). Procedures should be in Clinical and Laboratory Standards Institute (CLSI) format. Equipment Preventative Maintenance/Repair Service. The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all primary and back-up instrumentation and any incremental support equipment, e.g. water system, offered according to the following terms: Service Requirements A technical assistance center shall be available by telephone 24 hours per day, 7 days per week with a maximum call back response time of 30 minutes. Equipment repair service shall be provided during business hours Monday through Friday on site service as needed. All arrangements shall be coordinated between the Contractor and VA laboratory personnel. Equipment repair response time at the site shall be no more than 16 hours for service personnel with preferable same day service. Preventative maintenance will be performed as frequently as published in manufacturer s operators manual and within 2 weeks of the scheduled due date. Scheduled maintenance times should be flexible to minimize interruptions during peak workload times. A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following: date and time notified date and time of arrival serial number, type and model number of equipment time spent for repair, and proof of repair that includes documentation of a sample run of quality control verifying acceptable performance. Each notification for an emergency repair service call shall be treated as a separate and new service call. Assist the user in setting up and maintaining/troubleshooting user-defined assays. If the equipment provided by the contractor is requiring repair and is down in excess of 24 hours and the second analyzer goes down, the Contractor is to bear the cost of testing at an alternative location until the equipment is returned to a fully functional level. Upgrades - The Contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and the state-of the art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to system upgrades that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the contract; however, it does refer to significant changes in the hardware operational capability. Ancillary support equipment - The Contractor shall provide, install and maintain through the life of the 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. The Contractor will notify, within 24 hours, all participating facilities of any recalled reagents or equipment components. This must be accomplished by telephone, email, and/or certified mail. The contractor will provide sufficient replacement items to resolve the problem so no break in service is realized by the Michael J. Crescenz VAMC laboratory. In the case of a company merger and/or acquisition, the contractor will immediately notify the Contracting Officer for this Contract and provide a contingency plan of services to assure that no break in services is realized by the Michael J. Crescenz VAMC Laboratory. The Contractor shall provide a directory with the names and telephone numbers of all contact persons to be used by the participating facilities to inquire about billing issues, reagent shipments, service concerns, etc. The contractor is encouraged to quote a spectrum of value added incentives. Such incentives may include customer and professional service programs (i.e. PACE approved continuing education programs for clinical laboratory staff) and new innovations to assist the Michael J. Crescenz VAMC with the usage of the contractor s products/services in the most efficient manner. Interface Requirements The Contractor shall be responsible for providing all hardware required for the connection, implementation, and operation of the interface to the universal interface and any incremental fee that is required each time an instrument is added to an existing universal interface system (see Attachment A). 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. If the Michael J. Crescenz VAMC Laboratory 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. If the Michael J. Crescenz VAMC laboratory 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. 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. 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 and/or an on-line procedure manual in the instrument software. 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. 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) 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. 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 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 Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 90 days after the award of the 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 90 day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government. 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 90 days. During this same period all initial training of VA personnel in the operation and maintenance of said award shall also be completed. 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. At the end of 90 days from award of the contract, the awarded Contractor shall have full and sole responsibility for services under the awarded contract. 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. 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. 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.) 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. 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. 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. 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. Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the agreement for equipment. 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. 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. 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. 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. 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 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: Contractor must accept the system without the drive; 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 VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase. 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; 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 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. 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. Pricing should be included for all tests that are currently available to be run on the instrument leaving open the possibility for the Michael J. Crescenz VAMC to perform additional testing in the future. Pricing shall be based on the average yearly test volume per instrument/analyzer. This agreement will be a Cost per Reportable Contract. (Cost per reportable result) The Government estimates the volumes listed but does not guarantee volumes as listed; they are ESTIMATES ONLY. Estimated test volumes per month are listed below: Required Tests Borrelia (Lymes Screen) 139 Measles (Rubeola) 143 Mumps 140 Rubella 141 Syphillis Screening 188 Vitamin D 2875 Varicella Zoster (VZV) 105 Quantiferon TB Gold 235 Non required tests - (smaller volume testing possibly to be brought in house after initial installation and validation). Please provide pricing. Renin 20 Aldosterone 20 ACTH 15 1,25 dihydroxy Vit D 20 Calprotectin, fecal 15
 

Web Link

SAM.gov Permalink
(https://beta.sam.gov/opp/61152cb838014c11abc34dd92fc3b5fb/view)
 

Record

SN05531160-F 20200111/200109230132 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

---

| FSG Index  |  This Issue's Index  |  Today's SAM Daily Index Page |