Loren Data's SAM Daily™

FBO DAILY - FEDBIZOPPS ISSUE OF JULY 13, 2019 FBO #6441
SOURCES SOUGHT

65 -- 646-19-4-080-0673 | Microbiology BPA | EDA: TBD by Branch Chief | Current Milestone: TBD| Status:

Notice Date

7/11/2019
 

Notice Type

Synopsis
 

NAICS

325413 — In-Vitro Diagnostic Substance Manufacturing
 

Contracting Office

Department of Veterans Affairs;Network Contracting Office 4
 

ZIP Code

16602
 

Solicitation Number

36C24419Q0907
 

Response Due

7/17/2019
 

Archive Date

8/16/2019
 

Point of Contact

814-943-8164 x7232
 

Small Business Set-Aside

N/A
 

Description

1. BPA LANGUAGE 1.1. INTENT: Pursuant to Federal Supply Schedule (FSS) and FSS Contract Clause I-FSS 66 III 6605-5A, it is the intent of the Department of Veterans Affairs, (herein afterwards referred to as VISN 04 ) to establish a Blanket Purchase Agreement (BPA) for Automated Microbiological Instrumentation. The BPA shall be under the FSS Contract, Federal Supply Class (FSC) Group 66 III Cost Per Test (CPT)/ Cost Per Reportable Result (CPRR), Clinical Laboratory Analyzers. The Government will award a CPRR BPA to a single Contractor for Automated Microbiological Instrumentation. Contractor agrees to the following terms of the BPA exclusively with the VISN facilities listed by Attachment and awarded in the final BPA. However, as requirements change, facilities within VISN 04may be added or deleted by supplemental agreement of the Government and the Contractor. Additional tests/reagents/instrumentation may be added to the BPA as new technology becomes available on the market and added to the base FSS contract. 1.2. ORDERS: All products ordered under this BPA, placed against the Federal Supply Schedule Award Contract(s), are subject to the terms and conditions of the FSS contract. This BPA does not obligate any funds. The Government is obligated only to the extent of authorized orders actually issued under the BPA by authorized individuals. 1.3. PRICES AND TERMS: VISN 04 will provide an estimated volume by test as reflected in Attachment A for each individual medical center and outpatient clinic laboratory. Pricing is based on the AVERAGE daily test volume per instrument/analyzer for each facility. The Government estimates the volumes per facility as listed in Attachment A, but does not guarantee volumes as listed; they are estimates ONLY. 1.4. TERM OF AGREEMENT: : This will be a single award, firm-fixed price BPA with one base year and four, one year options and shall be effective for the term of the FSS Contract including additional FSS extensions. The Contractor is required to immediately notify the CO (Government Contracting Officer), in writing, if at any time the FSS contract upon which this BPA is based, is no longer in force. The resulting BPA shall be automatically extended for the remaining term of the BPA without modification upon any extensions of the Contractor s FSS contract. In addition, where a new FSS contract replaces Contractor s current FSS contract, the resulting BPA may be reassigned under the new FSS contract for the remaining term of the BPA with written agreement between Contractor and the contracting officer. This BPA is not a contract. If the Contractor fails to perform in a manner satisfactory to the CO, this BPA may be canceled with thirty (30) days written notice to the Contractor by the CO. The Contractor shall also reserve the right to terminate this contract with 30 days notification to the CO. This BPA shall be reviewed annually. VISN 04 intends to establish the base year of the agreement for the period of 9/10/2019 through 9/9/2020. 1.5. IDENTIFICATION: Delivery Orders issued shall be identified by their applicable FSS Contract Number and BPA Number. FSS & BPA identification numbers are assigned through the VHA Procurement Activity numbers will be assigned by each facility via the VA Electronic Contract Management System (eCMS). 1.6. ORDERING METHOD: The participating facilities may order products via Electronic Data Interchange (EDI), telephone, facsimile or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions. 2. DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK 2.1. SCOPE OF PROCUREMENT: 2.1.1. The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the statement of work. The instrument shall be able to simultaneously perform the testing 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). 2.1.2. Equipment must maintain, or preferably reduce the number of work stations or overall labor required to accomplish the required testing by each laboratory. 2.1.3. If Contractor offers a family of analyzers, VISN 04 technical evaluation panel will determine if instrumentation proposed meets needs of using facility. 2.1.4. Equipment shall be acquired for each of the clinical laboratories located at the VISN facilities listed in Attachment A. 2.1.5. The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Expiration date must be clearly marked on reagent, standards and control containers. Unexpected changes in methodology/technology shall be at the expense of the Contractor. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals determined at contract award. 2.1.6. Special handling for emergency orders of supplies: In the event that the supplies are found to be defective and unsuitable for use with the Contractor s equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor s equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery. 2.2. DEFINITIONS: 2.2.1. Cost per Patient Reportable Result (CPRR)- as defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers - Contractors are required to provide a price for a reportable patient result. The per patient reportable result price shall include costs covering: (1) five 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. Business Associate Agreement (BAA)- A business associate is an entity, including an individual, company, or organization that, on behalf of VHA, performs or assists in the performance of functions or activities involving the use or disclosure of PHI, or that provides certain services involving the disclosure of protected health information (PHI). VHA is a covered entity under the HIPAA Privacy Rule (Privacy Rule). HIPAA regulations require VHA to execute HIPAA-compliant BAAs with certain entities that receives, uses, or discloses VHA PHI in order to perform some activity for VHA. These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule. 2.2.3. Parameter Definition(s) - This section intentionally left blank. 2.3. TEST MENU: Refer to Attachment A for desired test menu and estimated annual volumes. 2.4. GENERAL REQUIREMENTS: 2.4.1. Primary analyzer(s) Base equipment offered that shall fully support the scope of operations (minimal requirements). Depending upon the technical functionality and the capabilities of the individual manufacturer s instrumentation, one analyzer or multiple analyzers may be required to meet the productivity specifications defined herein. In those instances, the additional analyzer(s) shall, likewise, be considered primary instrumentation and shall meet all of the technical specifications of this solicitation. Those additional analyzer(s) offered meeting the definition of a primary analyzer shall be equivalent to a back-up analyzer (see definition below) and shall replace the requirement for offering that category of equipment. 2.4.2. The system shall provide self-contained, automated identification and antibiotic susceptibility testing system for minimally aerobic, facultative, and fastidious microorganisms. 2.4.3. Operational Features- The instrumentation offered shall have the following: 2.4.3.1. The capability of performing analysis on 100% of the tests listed in Attachment A. 2.4.3.2. Sufficient capacity and throughput to meet the volume and service demands as defined in Attachment A. 2.4.3.3. 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. 2.4.3.4. A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system. 2.4.3.4.1. The accuracy of the barcode reading must have less than a 1% failure rate. 2.4.3.4.2. Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently. 2.4.3.5. Equipment must accept, at a minimum 10 characters in specimen identifier that is alpha and/or numeric depending on site. 2.4.3.6. Minimal daily, monthly, and periodic maintenance. 2.4.3.7. Ability to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage. 2.4.4. Technical Features- The instrumentation must be approved by the Food and Drug Administration (FDA) and shall have the following: 2.4.4.1. The capability of accurately and reliably identifying both gram negative and gram positive bacteria. 2.4.4.2. The capability of reporting susceptibility tests in accordance with FDA/CLSI guidelines. At a minimum, the equipment must provide Minimum Inhibitory Concentrations (MIC) values for the following antibiotic-organism combinations. 2.4.4.3. The information below must be updated as new versions of standards are released: 2.4.4.3.1. Antibiotics (check all that apply, use text boxes to include additional items): 2.4.4.3.1.1. Gram Positive Organisms 2.4.4.3.1.1.1. Daptomycin 2.4.4.3.1.1.2. Oxacillin 2.4.4.3.1.1.3. Amp / subbactam 2.4.4.3.1.1.4. Ampicillen 2.4.4.3.1.1.5. Cefazolen 2.4.4.3.1.1.6. Ceftreaxone 2.4.4.3.1.1.7. Ciprofloxacin 2.4.4.3.1.1.8. Erythromycin 2.4.4.3.1.1.9. Gent 2.4.4.3.1.1.10. Gent Synergy 2.4.4.3.1.1.11. Linezolid 2.4.4.3.1.1.12. Nitrofurantoin 2.4.4.3.1.1.13. Cefoxitin screen- MRSA 2.4.4.3.1.1.14. Rifempor 2.4.4.3.1.1.15. Strep Synergy Screen 2.4.4.3.1.1.16. Synercid 2.4.4.3.1.1.17. Tetracycline 2.4.4.3.1.1.18. Trethoprin / Sulfa 2.4.4.3.1.1.19. Vanc 2.4.4.3.1.1.20. Daptomycin 2.4.4.3.1.1.21. Oxacillon 2.4.4.3.1.1.22. Ampicillen 2.4.4.3.1.2. Gram Negative Organisms and Pseudomonas 2.4.4.3.1.2.1. Amikacin 2.4.4.3.1.2.2. Aztreonam 2.4.4.3.1.2.3. Ceftazidime 2.4.4.3.1.2.4. Imipenem 2.4.4.3.1.2.5. Piperacillin 2.4.4.3.1.2.6. Tobramycin 2.4.4.3.1.2.7. 2.4.4.4. The capability of detecting emerging antimicrobial resistance. 2.4.4.5. Comprehensive and extensive data base of bacteria and yeast species that is consistent with FDA/CLSI guidelines. 2.4.4.6. Software or equipment modifications as needed and, when commercially available, to comply with changes in standards for identification or susceptibility testing established by CLSI, Center for Disease Control (CDC) and other governing or authoritative bodies. Allow for manual modification of susceptibility breakpoints to comply with new CLSI guidelines until such time as the Contractor applies necessary software upgrades. 2.4.4.7. Comprehensive array of bacterial antimicrobial susceptibility panels which each individual facility may select to meet individual needs. Contractor shall supply a list of available susceptibility panels as well as a list of antibiotic exceptions for their methodology at time of proposal. 2.4.4.8. Capability to detect organisms that carry a carbapenemase enzyme. 2.4.4.9. Capability of producing an anti-biogram of organisms by selected body sites. 2.4.4.10. Built-in quality control program to regularly monitor system performance. 2.4.5. Data Management- The System shall have the following; 2.4.5.1. Capability to provide varied options for analysis and reporting/review of cumulative patient data on organisms isolated and antimicrobial profiles. 2.4.5.2. Capability to record, store and print the following information: 2.4.5.2.1. Required quality control and instrument maintenance information 2.4.5.2.2. Patient demographic information and specimen results 2.4.5.2.3. Capability of manipulating/sorting the patient demographic information and patient microbiology test results to generate epidemiological reports, i.e. antibiograms, etc. 2.4.5.2.4. Sufficient memory to store patient information and test results with downloading capability to an external medium for long term storage of patient records and other information. 2.4.6. Hardware Features- The instrumentation shall have the following: 2.4.6.1. A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory. 2.4.6.2. An on-board monitor/screen that is easily readable. 2.4.6.3. 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). 2.4.6.4. An uninterruptible power supply with line conditioner for each instrument provided. 2.4.7. The vendor must be able to supply an identification system that uses matrix-assisted laser desorption/ionization technology for identification of microbial organisms for sites within VISN 4 to assist with microbiology identification 2.4.8. The Contractor shall assist the Government with validation and method comparison studies. All materials and reagents needed for such correlation shall be provided 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. 2.4.8.1. The vendor is required to update MIC breakpoints to CLSI standards within 24 months of publication. 2.4.9. Reports- The Contractor shall provide to the Contracting Officer and other individuals (designated post-award) a copy of a quarterly report of sales, by ordering facility, within 30 calendar days after the close of each quarter s business. Reports are to reflect, at a minimum, total net sales amounts before discount, and discount amounts by ordering facility as well as the raw data used to develop these reports. These reports shall be used to monitor the commitment of each facility, reporting the savings realized and shall be shared with each participating facility, personnel associated with acquiring the products, and respective laboratory personnel. Additional invoice charges associated with reagent and/or supply wastage or repair parts included at no charge (per FSS awarded contract) shall not be accepted. There will be no additional charges for any reports required as part of the BPA. Attachment C may be used as a template to provide these quarterly reports. 2.4.10. Support Features- 2.4.10.1. 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. 2.4.10.2. Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other item included on the list of supplies defined in the Federal Supply Schedule contract and required to establish instruments for operation for performance of acceptance testing. 2.4.10.3. Training. The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility s services and minimally equivalent to the terms and conditions for training defined in the Contractor s Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers contract. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide training for minimally one operator per facility per year at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant. 2.4.10.4. 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: 2.4.10.4.1. Service Requirements 2.4.10.4.1.1. If an identification system from a different vendor is supplied by the BPA awarded vendor, then the vendor must cover any additional cost of any service contract. All instruments provided by the vendor shall have service covered by the vendor. 2.4.10.4.1.2. 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 24 hours. 2.4.10.4.1.3. Equipment repair service shall be provided during core business hours. See Attachment A defining core business hours of each facility included in this solicitation. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel. 2.4.10.4.1.4. Equipment repair response time shall be no more than 24 hours. 2.4.10.4.1.5. Preventative maintenance will be performed as frequently as published in manufacturer s operator s manual and within 2 weeks of the scheduled due date. 2.4.10.4.1.6. A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following: 2.4.10.4.1.6.1. date and time notified 2.4.10.4.1.6.2. date and time of arrival 2.4.10.4.1.6.3. serial number, type and model number of equipment 2.4.10.4.1.6.4. time spent for repair, and 2.4.10.4.1.6.5. proof of repair that includes documentation of a sample run of quality control verifying acceptable performance. 2.4.10.5. Each notification for an emergency repair service call shall be treated as a separate and new service call. 2.4.10.6. Upgrades - The Contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and the state-of the art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to system upgrades that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the BPA; however, it does refer to significant changes in the hardware operational capability. 2.4.10.7. Ancillary support equipment - The Contractor shall provide, install and maintain through the life of the BPA, as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, 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. 2.4.10.8. Interface Requirements 2.4.10.8.1. The Contractor shall be responsible for providing all hardware required for the connection, implementation, and operation of the interface to the universal interface and any incremental fee that is required each time an instrument is added to an existing universal interface system (see Attachment A). 2.4.10.8.2. The Contractor shall provide any and all necessary software support for insuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself. Information necessary to make the determination for type and amount of interfacing equipment is supplied in Attachment A. 2.4.10.8.3. If a site already has a universal interface box, the Contractor is responsible for everything leading up to the box including any incremental fee required to add additional equipment (e.g. licenses, ports/cards, cables, software, etc.) to the universal interfacing system. 2.4.10.8.4. If a site does not have a universal interface and one is needed to optimally interface the instrument, then the Contractor is responsible for the acquisition of the universal interface box and everything else needed to connect with VA computerized hospital information system. 2.4.10.8.5. If there are any software upgrades in the instrument during its life, the Contractor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VA computerized hospital information system. 2.4.10.9. 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 CSLI format or an on-line procedure manual in the instrument software. 2.4.10.10. 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. 2.4.10.10.1. The determination and description shall address the following: 2.4.10.10.1.1. Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24) 2.4.10.10.1.2. Waste ignitability (Reference 40 CFR §261.21) 2.4.10.10.1.3. Waste corrosivity (Reference 40 CFR §261.22) 2.4.10.10.1.4. Waste reactivity (Reference 40 CFR §261.23) 2.4.10.10.1.5. Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR §261.31) 2.4.10.10.1.6. Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40 CFR §261.33) 2.4.10.10.1.7. Solid Waste (Reference 40 CFR §261.2) 2.4.10.10.1.8. Exclusions (Reference 40 CFR §261.4) 2.4.10.10.2. 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. 2.4.10.10.3. 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: 2.4.10.10.3.1. Barium (Total) 2.4.10.10.3.2. Cadmium (Total) 2.4.10.10.3.3. Chromium (Total) 2.4.10.10.3.4. Copper (Total) 2.4.10.10.3.5. Cyanide (Total) 2.4.10.10.3.6. Lead (Total) 2.4.10.10.3.7. Mercury (Total) 2.4.10.10.3.8. Nickel (Total) 2.4.10.10.3.9. Silver (Total) 2.4.10.10.3.10. Zinc (Total) 2.4.10.10.3.11. Arsenic (Total) 2.4.10.10.3.12. Selenium (Total) 2.4.10.10.3.13. Tin (Total) 2.4.10.10.3.14. pH 2.4.10.10.3.15. Flash point (to higher than 200 F) 2.4.10.10.3.16. BOD; biochemical oxygen demand 2.4.10.10.4. 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. 2.4.10.11. Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 90 days after the award of the BPA. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. Contractor shall not be penalized for implementation timelines that extend beyond the 90 day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government. 2.4.10.11.1. Upon award of a BPA, the transition period for the awarded BPA to have all equipment and peripherals installed and operational shall be from date of award through 90 days. During this same period all initial training of VA personnel in the operation and maintenance of said award shall also be completed. 2.4.10.11.2. Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor s submitted plan shall not exceed 90 days for the transition of all services under the awarded BPA including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations. Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate BPA for cause under the Termination for Cause clause of the BPA. 2.4.10.11.3. At the end of 90 days from award of the BPA, the awarded Contractor shall have full and sole responsibility for services under the awarded BPA. 2.4.11. Standard and Quality of Performance- This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the delivery order [or BPA] is accepted by the Government. This also includes replacement, substitute machines and machines that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the Contractor s technical specification or as quoted in any BPA at an effectiveness level of 90% or more. 2.4.11.1. In the event that equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests shall continue on a day-by-day basis until the standard of performance is met for a total of 30 consecutive days. 2.4.11.2. If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order in accordance with the provisions of FAR 52.212-4 entitled Termination for Cause. (The Contractor shall receive revenue for tests reported during the 90-day acceptance period.) 2.4.11.3. Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period of time when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the Government makes a bona fide attempt to contact the Contractor s designated representative at the prearranged contact point until the system or machine(s) is returned to the Government in proper operating condition. 2.4.11.4. During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work shall be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when in excess of the minimum of 100 hours. [reference: Master FSS] 2.4.11.5. The Government will maintain daily records to satisfy the requirements of this paragraph and shall notify the Contractor in writing of the date of the first day of the successful period of operation. Operations use time and downtime shall be measured in hours and whole minutes. 2.4.11.6. During the term of the BPA, should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the COR to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer s instructions, shall be solely that of the Contractor. [reference: Master FSS] Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the agreement for equipment. 2.4.12. Government s Responsibility- The user will perform routine maintenance and cleaning as required in the manufacturer s operation and maintenance instructions. The user shall maintain appropriate records to satisfy the requirements of this paragraph. 2.4.13. 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. 2.4.14. The Contractor will identify if removable media is required to perform their duties. The Clinical Engineering Department will ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device/system. Any Contractor with patient sensitive information that is imported into the removable media device for any reason must purge all patient sensitive information prior to departure from the facility. 2.4.15. Prior to termination or completion of this BPA, Contractor/subcontractor must not destroy information received from VA, or gathered/created by the Contractor in the course of performing this BPA without prior written approval by the VA. Any data destruction done on behalf of VA by a Contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the Contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination or completion of the BPA. 2.4.16. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the BPA or (ii) disposal or return of the IT equipment by the Contractor/subcontractor or any person acting on behalf of the Contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the Contractors/subcontractors that contain VA information must be 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 BPA or disposal or return of the IT equipment, whichever is earlier 2.4.17. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the Contractor at the end of lease, for trade-in, or other purposes. The options are: 2.4.17.1. Contractor must accept the system without the drive; 2.4.17.2. VA s initial medical device procurement includes a spare drive which must be installed in place of the original drive at time of turn-in; or 2.4.17.3. VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase. 2.4.18. Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then; 2.4.18.1. The equipment Contractor must have an existing BAA if the device being traded in has protected health information stored on it and hard drive(s) from the system are being returned physically intact; and 2.4.18.2. Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or BPA. 2.4.18.3. A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The Information Security Officer (ISO) needs to maintain the documentation. 2.5. Contacts 2.5.1. James E. Van Zandt VA Medical Center 2907 Pleasant Valley Boulevard Altoona, PA 16602-4377 CONTACT: Jennifer Harkins PHONE: (814) 943-8164 x7099 2.5.2. Department of Veterans Affairs Medical Center 135 East 38th Street Boulevard Erie, PA 16504-1596 CONTACT: Bernadette Hall PHONE: 814-860-2178 2.5.3. Department of Veterans Affairs Medical Center 3900 Woodland Avenues Philadelphia, PA 19104 CONTACT: Sahil Patel PHONE: 215-823-5800 x 5098/5272 2.5.4. VA Pittsburgh Healthcare System University Drive Pittsburgh, PA 15240 CONTACT: Kevin Frank PHONE: 412-360-6558 2.5.5. Department of Veterans Affairs Medical Center 1111 East End Boulevard Wilkes-Barre, PA 18711 CONTACT: Sharon Ford PHONE: 570-824-3521 Ext. 27535 2.5.6. VA Medical & Regional Office Center 1601 Kirkwood Highway Wilmington, DE 19805 CONTACT: JoAnnna Bakanas PHONE: 302-994-2511 ext. 4388 DISCLAIMER This RFI 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 RFI. End of Document NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (11-JUL-2019); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT 877-472-3779 or fbo.support@gsa.gov REGARDING THIS ISSUE.
 

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(https://www.fbo.gov/spg/VA/PiVAMC646/PiVAMC646/36C24419Q0907/listing.html)
 

Record

SN05366651-F 20190713/190711230021 (fbodaily.com)
 

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