Loren Data's SAM Daily™

FBO DAILY - FEDBIZOPPS ISSUE OF JULY 15, 2017 FBO #5713
DOCUMENT

Q -- RFI to determine potential SDVOSB and VOSB offerors for Cost Per Reportable requirement for Chemistry/ immunochemistry patient testing for the Birmingham VA Medical Center. - Attachment

Notice Date

7/13/2017
 

Notice Type

Attachment
 

NAICS

334516 — Analytical Laboratory Instrument Manufacturing
 

Contracting Office

Department of Veterans Affairs;Birmingham VA Medical Center;700 South 19th Street;Birmingham AL 35233
 

ZIP Code

35233
 

Solicitation Number

VA24717N0731
 

Response Due

7/20/2017
 

Archive Date

9/18/2017
 

Point of Contact

Connie Ganier
 

E-Mail Address

3-8101
 

Small Business Set-Aside

N/A
 

Description

Synopsis This is a source sought announcement only. All responses will be used for market analysis in determining the availability of potential qualified SDVOSB or VOSB businesses that may be used to determine appropriate acquisition strategy. No solicitation is being issued at this time, but may be issued at a later date. This notice shall not be construed as a commitment by the Government to ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. All information submitted in response to this announcement is voluntary; the Government will not pay for information requested not will it compensate any respondent for any cost incurred in developing information provided to the Government. The North American Industry Classification Systems (NAICS) Code proposed for the requirement is 334516 Analytical Laboratory Instrument Manufacturing. The size standard for NAICS 334516 is 1,000 Employees. The Birmingham VA Medical Center is seeking sources from Service Disable Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), to provide all labors and materials necessary in the performance of the requirement as provided in the Statement of Work (SOW) below. Interested firms are requested to provide their aforementioned information, along with interest and capability statements no later than 20 July 2017. No pricing input is being requested. This Sources Sought Notice is issued for the purpose of market research in accordance with Federal Acquisition Regulation Part 10. Additional information regarding this requirement will be posted for viewing on FedBizOpps at https://www.fbo.gov/ as it becomes available. All potential offerors are reminded that lack of registration in the System for Award Management (https://www.sam.gov) will make an offeror ineligible for contract award. NOTE: It is the responsibility of all potential offerors to monitor the FedBizOpps web site for release of any future synopses or release of the solicitation and any associated amendments. Submissions to this notice may be emailed to Contract Specialist, Network Contracting Office 7 at connie.ganier@va.gov. When emailing your response, please note that due to increased firewall protections some emails may be blocked; therefore, follow-up via telephone (if an acknowledgement is not received back via email) is strongly recommended to ensure receipt of your submission by the Government. Any information provided by industry to the Government as a result of this sources sought synopsis is strictly voluntary. Responses will not be returned. No entitlements to payment of direct or indirect costs or charges to the Government will arise as a result of contractor submission of responses, or the Government's use of such information. No solicitation document is available at this time; this notice is to acquire information only. Vendors interested in providing an offer will have to respond to a solicitation announcement published separately. See Statement of Work provided below for further details of requirement. STATEMENT OF WORK Chemistry/Immunochemistry Equipment/System to Perform Diagnostic Patient Testing Described Herein Through a Cost-Per-Reportable Contract/Task Order Cost-per-Reportable (CPR) is an all-inclusive price. The price shall include costs covering: (1) equipment use, (2) all reagents, standards, quality controls, supplies, 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. 1. BACKGROUND: VA Medical Center Birmingham, AL (BVAMC) currently uses 2 fully automated configurations (one primary and one secondary/backup) along with pre- and post-analytical automation to perform Chemistry/Immunochemistry testing through CPR task order which will expire April 23, 2018. Therefore, we must obtain a new CPR task order to continue uninterrupted patient testing. This new requirement is expected to begin February 1, 2018 through January 31, 2019 with four (4) one-year option periods. 2. SCOPE: BVAMC needs this fully automated equipment to perform the specified patient testing through a CPR task order in Pathology & Laboratory Medicine Service (P&LMS) at BVAMC, 700 South 19th Street, Birmingham, AL. 2.1 The cost-per-reportable price must include the use of all equipment (including, but not limited to primary and secondary/backup analyzer(s), pre- and post-analytical automation, and independent data management system) and necessary peripherals (carts, printers, UPS systems, barcode readers, etc.), to perform and report Chemistry/Immunochemistry testing (specified below), using the same methodology. The price must also include calibrations/controls/repeats; delivery and installation; reagents, controls, and consumable products; shipping and handling; initial off-site training (includes airfare, room, board, and training materials), and maintenance/service coverage. 2.2 The vendor selected is responsible for equipment and service components. 2.3 The equipment/system shall be able to simultaneously perform the required testing 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). 2.4 The equipment shall maintain, or reduce the number of work stations or overall labor required to accomplish the required testing. Proposal should include provisions for back-up instrumentation using the same methodology so the Laboratory can provide essential testing without compromising turn-around for all tests on menu. 2.5 The equipment shall provide the following required test menu. All of the required tests must run on the vendor s system with NO manual pre-analytical preparation/pre-treatment of the sample. Required Test Menu Projected Workload Acetaminophen 203 Alanine Aminotransferase (ALT) 87,415 Alcohol Ethyl 2,265 Alpha Fetoprotein (AFP) 1,860 Albumin 86,948 Alkaline Phosphatase (ALP) 83,685 Ammonia (NH3) 1,127 Amphetamines Screen, Urine 22,613 Amylase (Serum, Urine, and Fluid) 2,128 Aspartate Aminotransferase (AST) 83,721 Benzodiazepine Screen, Urine 22,612 Bilirubin, Direct 12,591 Bilirubin, Total 83,714 Bupenorphrine Screen, Urine 22,611 Calcium, Serum and Urine 129,496 Cannabinoids Screen, Urine 22,611 Carbamazepine 144 Carbon Dioxide (CO2) 128241 Carcinoembryonic Antigen (CEA) 541 Chloride, Serum and Urine 128,369 Cholesterol HDL 56,826 Cholesterol LDL, Direct 1,284 Cholesterol, Total 57,459 Cocaine Screen, Urine 22,625 Cortisol 347 C-Reactive Protein (High Sensitive) (HS) 3,958 Creatinine Kinase (CK-MB) (ng/mL) 10,832 Creatine Kinase (CK) 13,376 Creatinine, Serum and Urine 155,360 Digoxin 773 Ferritin 7,051 Folate 19,852 Gamma Glutamyl Transpeptidase (GGT) 583 Gentamicin 15 Glucose, Quantatative (Serum, Urine, and Fluid) 129,486 Glycohemoglobin A1C 48,424 Hepatitis A IgM Ab 1,925 Hepatitis A Total 47 Hepatitis B Core IgM Ab 1,727 Hepatitis B CORE Total Ab 1,976 Hepatitis B Surface Ab 3,341 Hepatitis B Surface Ag 3,990 Hepatitis C Antibody 8,049 HIV, Ab gen 4 6,465 Human Chorionic Gonadotropin (HCG-Beta) 164 Iron, Total 9,150 Lactate Dehydrogenase (LDH) 1,273 Lactic Acid 7,843 Lidocaine 22 Lipase, blood 2,887 Lithium 386 Magnesium (Serum and Urine) 24,798 Methadone Screen, Urine 22,611 Microalbumin 19,052 Opiate Screen, Urine 22,617 Oxycodone Screen, Urine 22,619 Parathyroid Hormone (PTH) Intact 1,005 Parathyroid Hormone (PTH) STAT (Interoperative) 107 Phenobarbital 48 Phenytoin 305 Phosphate, Inorganic (Serum and Urine) 49,376 Potassium, Serum and Urine 128,540 Pro B-type Natriuretic Peptide (Pro-BNP) 4,428 Procalcitonin 7,843 Prostate Specific Antigen (TPSA) 26,836 Protein, Total 83,844 Protein Quant, Urine and Fluid 2,883 Rapid Plasma Reagin (RPR) 2,945 Salicylates 185 Sodium, Serum and Urine 129,252 Testosterone 30,876 Theophylline 139 Thyroid Stimulating Hormone (TSH) 40,198 Thyroxine, Free (FT4) 31,780 Tobramycin 6 Total Iron Binding Capacity (UIBC or TIBC) 18,280 Triglyceride without extract 56,981 Troponin I 9,422 Urea Nitrogen 128,904 Urea Urine 303 Uric Acid, Serum and Urine 4,549 Valproic Acid 706 Vancomycin 2,210 Vitamin B12 19,852 Vitamin D 25 Hydroxy 20,291 2.6 Projected Test Volume: Total tests per year are estimated at 2.4M reportable tests, excluding calibrators, controls, and repeats. Currently, it is estimated that there will be an annual growth in sample volume of approximately 7% per year. *NOTE: Test volumes/workload are based upon prior history and are not a guaranteed minimum. Specimen integrity checks shall be made on all specimens at no additional charge. If at any time during the contract period, tests are not available on this list, the vendor shall reimburse Birmingham VAMC any additional costs associated with the procurement of another source of test performance. 2.7 There shall be flexibility for future expansion of testing, using the same instrumentation footprint. New tests may be added as requested to the menu. All the reagents for test validation for new tests shall be supplied at no additional cost. 2.8 For new tests vendor/technical support specialist shall perform all validation studies including: installation/set-up, correlation studies (evaluation/comparison data sufficient to satisfy CAP standards) and normal range studies at no initial charge. 2.9 Additional Fixed Cost Disclosure - All pieces of equipment required for system operation as requested, including but not limited to: Instruments, automation line equipment parts and costs including, but not limited to, centrifugation capability suitable to handle the highest hourly influx in a 24 hour period, a decapper, bar code labeler for daughter tubes if the chosen vendor s equipment produces daughter tubes, and sample sorter/storage module, service agreements and maintenance of all equipment, hardware and software including all installation costs, service, maintenance and future software upgrades and requested training trips per year, are to be separated into an initially defined total cost disclosure for the contract period. CPRR shall note test cost plus additional defined fixed costs per test/surcharge. Annual review of test volumes will be audited and additional fixed cost per test shall be adjusted, as applicable. Increase in test volume shall not incur increase in additional fixed costs unless new equipment has been added in addition to the current provided services. 3. GENERAL REQUIREMENTS: 3.1 The vendor shall provide all supplies and services as described herein in the SOW. The Schedule of Pricing below shall be utilized by interested offerors to submit their cost proposal. 3.2 The purpose of this SOW is for the VA to obtain the greatest benefit in response to the requirements. 3.3 Offered models of equipment shall be capable of producing accurate and reproducible assays on patient samples. Model shall provide accurate test assay results for sample up to the manufacturer's defined maximum test per hour without excessive malfunctions, breakdowns, or service calls. 3.4 Offered equipment shall be new state-of-the-art equipment. All offerors must submit an offer for new equipment, not previously used. Remanufactured and discontinued models will not be accepted. 3.5 The awarded contractor shall provide all necessary upgrades to the equipment hardware and operating system software, at no additional cost to the Government. These enhancements shall be delivered and installed at the medical facility within 60 days of issuance to the commercial market. 3.6 The models being offered must be in current production as of the date this offer is submitted. For purposes of this solicitation, current production shall mean that the analyzer model being offered is being manufactured as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable. 3.7 Contractor shall provide a printer for analyzer(s) and provide replacement printer(s), as needed, if applicable, at no extra charge. 3.8 Contractor shall provide all manuals, documents, and initial supplies. Includes the right to reproduce any printed materials supplies with the product for the purpose of using the product. 4. SYSTEM REQUIREMENTS: 4.1 Only instruments which are FDA approved will be considered, and must be operational and interface with VA Laboratory Computer systems and upgrades. Test methods must be FDA approved with limited recalls due to product failures. This must be a "turn-key" system. 4.2 The system must contain random access technologies that improve workflow. 4.3 Windows-based program(s). All hardware, including middleware shall run on Windows 7 or newer version of Windows. 4.3 Expected throughput - Ability to manage testing workflow of high volume laboratory with an initial 2.4 M/ reportable tests/year where at least 30% of the testing is performed during the afternoon shift during a two hour period. A guaranteed functional platform must be available at all times by providing an analytical system composed of two units which are identical in composition and able to function either individually or coinjointly. 4.4 Specimen integrity evaluation on all samples as needed at no additional cost, i.e., serum indices. 4.5 Can repeat and reflex test, auto-rerun and auto-dilute. 4.6 System shall include appropriate water reservoir for provision of high laboratory-grade water (deionized water) supply for minimal operation for 1-2 hours during downtime/maintenance/change over. 4.7 Result times of less than 1 hour are very important in the management of emergency room and other critically ill patients. STAT test results shall be available in 30 minutes from the time loaded on the analyzer to the time results are available. STAT loading shall be available on instruments with prioritization of STAT over routine testing. 4.8 Minimal calibration requirements for all tests; ability to pre-calibrate new lots of reagent prior to use. 4.9 Ability to load reagents while the instrumentation is in operation. 4.10 Analyzers must have accurate capability of monitoring reagent usage, be capable of maintaining/storing on board supplies/reagents for 24 hours of patient testing on the combined platform, and provide reagent inventory upon request, in real time. 4.11 Quality methods with CV acceptability on College American Pathologist (CAP) Proficiency testing evaluations. 4.12 Quality control frequency not to exceed once/24 hours/instrument platform. 4.13 Open channel availability for adaptation of commercially available reagents not produced by vendor. 5. AUTOMATION SYSTEM - PRE/ POST ANALYTIC AND LINE PROCESSING REQUIREMENTS: 5.1 System Manager receives specimen and records time, directs the scheduling, routing, and tracking of specimen carriers on the conveyor system from loading to final disposition. The information system component of this laboratory automation system (LAS) must be able to communicate with Lab information system for ordering information to be sent from Lab information system to the System manager and shall include but not be limited to: order code or name, order priority, tube type, accession number, container id, collect date and time, and receipt date and time. 5.2 Sorter/Outlet station Sorts specimen tubes into appropriate racks based on the test to be done (such as an off-line instrument or manual procedure by preselected rules). Storage racks for minimum of 7000 specimens shall be included for online or offline storage. Automated delivery and organization of specimens to outlet station based on bar-coded information. 5.3 Minimum of 2 temperature-controlled centrifuges capable of centrifugation of sample at 3000 RPM for 10 minutes, or equivalent RCF rating for the type of patient tube being used. Centrifuges shall be capable of having their time and RPM easily adjusted as necessary in order to meet any changing future standards. 5.4 Automated placement of specimens into and removal from centrifuges with minimum loading and unloading times for maximum productivity. 5.5 Capable of differentiating spun and un-spun samples with minimal operator intervention. 5.6 Patient Identification- the barcode of the specimen tube or rack must be validated multiple times throughout the automation system to assure positive patient identification at all times. 5.7 Automated receipt of orders and patient information by reading bar coded specimens and interfacing information into VA Lab computer system. 5.8 Optimized automated delivery of specimens to all analyzers for parallel processing to provide best turnaround times and meet specimen handling requirements. 5.9 Automated tracking of specimen location and testing status of a specimen. 5.10 Capping and recapping system in an enclosed environment to prevent distribution of bio-hazardous aerosols. Note: recapping refers simply to resealing the tube opening in such a way that no biohazardous materials shall leak out, even if the tube were to be accidentally upset. 6. MIDDLEWARE-INTEGRATED DATA MANAGEMENT (INCLUDES APPROPRIATE LICENSE(S) AND ALL NECESSARY PERIPHERALS) REQUIREMENTS: 6.1 Integrated central processing unit with sufficient data storage and printing capability to accommodate and provide immediate access to more than 3,000 patient records per day. 6.2 Ability to manage rules for optimal specimen handling with alert system with ability to send automated comments based on the rules to patient host record. Linearity limits. "Add-on" or reflex tests, repeats for critical value tests, review for specimen integrity and delta checks on previous patient results are examples of automatic rules functions required. 6.3 Specimen Integrity based rules to cancel/edit tests based on the test performed and the interfering substance. Cancelled test must be able to transmit to the host along with the appropriate comment. 6.4 Bi-directional Interface shall be able to interface and automate all instruments with orders and results separated for optimal transmission capable of automatically uploading test results. 6.5 Back up to network data management handling. 6.6 Software management features with rules capable of preparing data for auto validation prior to host transmission. 6.7 System must interface instruments to Data Innovations interface manager. The system must include the necessary software/hardware (drivers) for bi-directional interface with Data Innovations, or other LIS vendor, LIS, where applicable. Software must be compatible with all barcode styles. 6.8 Data Management with record storage including instrument of record for all patient results. 6.9 Compatible with external vendor software for Unity real time Quality Control (QC) program. 6.10 All software and software licenses, interfaces, and hardware (e.g. servers, printers, monitors, UP, etc) shall be included with cost of hardware required. 6.11 Patient Mean Analysis Quality Control program - Required to have a QC program available on instruments or through middleware to monitor trends of test methods. 6.12 Comprehensive on board QC Program, including Troubleshooting or System Validation QC material. The system must have quality control data storage and reporting capabilities, the ability to view and print daily and monthly QC results, view and print Levy Jennings graphs, visually alert the operator of QC failures and to document out of range QC. 6.13 Bar Codes - All bar code readers must be capable of reading and decoding any label when manually applied to a specimen tube in accordance with the guidelines described in the Clinical and Laboratory Standards Institute (CLSI) standard, Laboratory Automation: Bar Codes for Specimen Container Identification, NCCLS Document Auto2-A, Approved Guideline, Vol. 20, No. 19, October 2005, or its successors. 7. REMOTE INSTRUMENT MONITOR: 7.1 Contractor shall provide remote access method to meet HIPPA and VA confidentiality requirements for customer support staff and remote diagnostic services. 7.2 Customer Support Staff of the vendor must obtain a VPN (virtual private network) to be able to configure the system to allow for diagnostics and troubleshooting/support services. Vendor staff with access to VA medical record must provide satisfactory documentation of receiving HIPAA training and complying with all HIPAA and VA patient confidentiality requirements. 7.3 An approved remote network communication system, must be provided, that continuously collects and monitors performance data of the analytical systems following all the policies and procedures outlined in VA Directive 6500, Information Security Program, its handbooks, and its successors, to ensure appropriate security controls are in place. 8. REAGENTS AND SUPPLIES REQUIREMENTS: 8.1 Inventory Management - The Contractor is required to provide a continuously stocked inventory of reagents, calibrators, troubleshooting controls, required consumable supplies including all routinely replaced parts, disposables and any other materials required to properly perform tests on the equipment. Unexpected changes in methodology/technology shall be at the expense of the vendor. Alert/Notification of all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to lab chiefs or designee. 8.2 Any items excluded by the vendor but required for operation of the system at any time, must be delineated in their technical proposal. The cost of any excluded items must be disclosed in the cost proposal. 8.3 Quality of Reagents, Supplies and Disposables - The contractor shall assure that all supplies provided/ordered for use on their equipment will be of the quality necessary to produce a quality product. The reagent quality must be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP) and the Joint Commission on Accreditation of Health Care Organizations (JCAHO). 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 herein, the contractor is required to deliver the supplies within 24 hours of receipt of the verbal order, if verbal order is received by 1 pm CST time, for priority delivery from the government activity. This shall be done at no cost to the government, in sufficient quantity as required to allow operation of the contractor's equipment for one week (under normal government test load volume). The vendor shall reimburse the facility for any costs/supplies related to tests performed by another vendor or sent to a referral laboratory when reagents were not available due to product issues or instrumentation failure. 8.4 Hazardous Constituents - For reagents with hazardous constituents, the Contractor shall provide a mechanism for the Laboratory to meet local discharge requirements. 8.5 Shipping Charges - No delivery charges for shipping or fee handling. Any additional costs such as Industrial Funding Fees, special shipping and handling fees, or other usage fees must be clearly indicated in the price quote and included in CPRR. 8.6 Shipping Schedule - The specific shipping schedule shall be determined/established in conjunction with BVAMC Chemistry Supervisor or designee. Shipments shall be made to BVAMC as scheduled, or as ordered. 8.7 Special Handling for Emergency Orders of Supplies - If additional requests for emergency supply delivery are required by the government, the contractor shall honor them until the arrival at the government site of the monthly standing order or routine supply delivery. 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 or inventory management, 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 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). 8.8 Returned Goods - The VA is responsible for inspecting all products shipped and gives the contractor written notice of rejection within thirty (30) calendar days following receipt or installation by the contractor. After acceptance, no products purchased hereunder may be returned without the prior authorization of the contractor and in conformity with their return policy. All returns of non-defective products are subject to a restocking charge. 9. MAINTENANCE AND SERVICE SUPPORT REQUIREMENTS: 9.1 Contractor shall provide telephone assistance 24-hours/day, 7 days/week, 365 days per year. Following determination that service is required, technical on - site support must be provided according to Emergency Repairs below. 9.2 The Contractor shall provide maintenance to keep the equipment in good operating condition and subject to security regulations. The government will provide the contractor access to the equipment to perform maintenance service according to the maintenance and service terms herein. 9.3 Preventative Maintenance - Contractor shall provide regular, scheduled maintenance to assure the continued reliable operation of the equipment. These preventive maintenance visits shall be of a frequency that conforms to the manufacturer's operation and maintenance instructions for the supported equipment. 9.4 Emergency Repair Contractor shall provide for emergency repairs 7 days/week. Emergency repairs shall be performed after notification that the equipment is inoperative. The contractor shall provide the government with a designated point of contact and shall make arrangements to enable its maintenance representative to receive such notification. The contractor shall perform emergency repair service within 24 hours of time of notification of the malfunction. 9.5 The contractor shall provide all tools, parts, and labor needed for preventive maintenance and repairs. Travel, per diem, and other expenses associated with the preventive maintenance and repairs shall be borne by the contractor. 9.6 Malfunction Incident Report - The contractor shall furnish a malfunction incident report to the department upon completion of each maintenance call. The report shall include, as a minimum, the following: 9.6.1 Date and time of arrival; 9.6.2 Serial number type and model numbers(s) of equipment; 9.6.3 Time spent for repair; 9.6.4 Description of malfunction and; 9.6.5 Proof of repair. 9.7 Maintenance Support - Service repair person locally based within the Birmingham VISN 7 geographical area. 9.8 Replacement of Laboratory Equipment - During the contract period, should the repair record of any laboratory equipment reflect a downtime of 10% or more of the normal working days in one calendar month, a determination will be made by the representative of the government to replace the initial laboratory equipment with new equipment. The responsibility of maintaining the equipment furnished in good condition shall be solely that of the contractor. 9.9 Patient Data Handling Due to the nature of this requirement (clinical laboratory diagnostic testing system), the contractor s maintenance/service repair/installation person(s) may have incidental access to patient information during installation or servicing the contractor s equipment. Any access to this information is incidental; it is not required by the contractor to perform the work outlined herein. A Business Associate Agreement (BAA) is not required. No hardware is to be removed from any location, without written approval and removal of data by the VA Office of Information and Technology (OI&T) department. Failure to comply with this VA requirement may result in prosecution. See Equipment Removal Requirement. 9.10 Daily/Routine Maintenance The system shall require minimal system maintenance, including limited reagent preparation prior to use. BVAMC technical staff (user) will perform routine maintenance and cleaning as required in the manufacturer's operation and maintenance instructions. The BVAMC user will maintain appropriate daily records to satisfy the requirements of this paragraph. 9.11 Maintenance Credit for Equipment Malfunction - If a machine remains inoperative due to a malfunction through no fault or negligence of the government for a total of 24 hours or more, the contractor shall be assessed damages at the rate of 1/30 of the preceding average three month CPRR billings times the total number of days certified as downtime for each incident shall start from the time the user makes a bona fide attempt to contact the contractor's designated representative at the prearranged contact point until the machine is returned to good operating order less any non-contracted maintenance (emergency repairs) days. 9.12 Failure Mean Time Disclosure - The contractor shall state the failure mean time (between failure and mean time to repair) for each piece of equipment offered.The Contractor shall provide emergency backup equipment. 10. EQUIPMENT AND SERVICE PROPOSED: The contractor shall complete the following table with the equipment and service plans proposed to meet the requirements specified in the Statement of Work herein. Proposed Equipment Contractor's Proposed Service Plan 11. Training and Technical Service Training Requirements: 11.1 The contractor shall provide an off-site (manufacturer facility) instrument training program that is coordinated with and timely to the equipment installation at no additional charge. This shall include training on the operation of the system, data manipulation, and basic troubleshooting and repair. This shall be available for the maximum number of operating personnel for each instrument installed and all automation system components at the time of installation. User training is to include all costs of off-site training, i.e., transportation (air and ground), room and board, etc. 11.2 The contractor shall provide additional training slot(s) for each completed year of this agreement, upon request, at no additional charge. 11.3 On-site training by contractor shall also be supplied to all laboratory staff, as needed. 11.4 Vendor shall provide/install/train users on the data management system with either off site or in house training. On-site refresher training in renewal option years of the contract shall also be made available annually. 11.5 In addition, the contractor shall provide supplemental operating training to above government personnel, without additional charge to the government, upon installation of the upgrade in equipment hardware or operating system software connected with the operation of an instrument already furnished. 11.6 The contractor, at his/her discretion, may make additional training available at his/her facility on terms and conditions mutually agreed upon by the agency and the contractor. 11.7 Operator Procedure Manuals - Two Operator and Service manuals along with CLSI compliant procedures must be furnished for each instrument model supplied. All technical procedures must be provided electronically CLSI format, using software compatible with Laboratory's computer system, for local modification to meet CAP requirements. 12. Installation and Initial Set Up Requirements: 12.1 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. 12.2 Space Requirements, Systems, Specifications - Configuration of the proposed equipment must be able to conform to the BVAMC space currently allotted for this function. System specifications must all be disclosed in the proposed space. A site visit/walk-through is available upon request and will be scheduled at the convenience of the BVAMC Clinical Laboratory. Arrangements shall be made through the COR, or designee, to establish an acceptable time to ensure minimum interruption of patient care. The site visit/walk-through must be requested in sufficient time to be completed at least 5 days before the close of the subject solicitation. 12.3 Crossover from current to new instrumentation must be performed timely and efficiently with no interruption in patient care laboratory service and minimal impact to staff. 12.4 Installation Procedures - The contractor shall be responsible for installation, which consists of in-house delivery, positioning, and mounting of all equipment listed on the delivery order and connections of all equipment and interconnecting wiring and cabling if applicable in coordination with the facility Biomedical Engineer, P&LMS Chemistry Supervisor or designee, and P&LMS Laboratory Information Manager. Upon receipt of notice to proceed with installation, it shall be the contractor s responsibility to inform the Contracting Officer of any problems which may be anticipated in connection with installation or which will affect optimum performance once installation is completed. In the event that progress of the installation is interrupted through no fault of the contractor, the continuous installation referenced in the preceding paragraphs may be terminated until such time as the cause of delay has been eliminated, and then shall be resumed within 24 hours after the contractor has been notified that work may again proceed. 12.5 Method Performance/Comparison This shall be at the expense of the Contractor, shall include linearity material and reagents, and be consistent with current CLSI and related documents, CAP Standards and Federal Regulations, for the following: 12.5.1 Correlation studies for each analyte - A minimum of 30 samples, spanning the reportable range, shall be run by the present and the new contracted method. Vendor shall analyze numbers and provide statistical data to accept the new method. Statistics shall consist of at least mean, bias, slope, y-intercept, correlation coefficient, analysis, and meet current standards defined by CLSI. Linearity analysis shall be performed on new contracted instrument(s) for each analyte to determine reportable range with data reduction in accordance with CLSI guidelines. Precision studies shall be performed utilizing normal and abnormal control material. This should consist of a within run precision study of 10 normal and 10 abnormal controls for each analyte. Analytical Measuring Range may be validated concurrently with the linearity verifications. Specificity studies: Adverse effects for increased bilirubin, hemolysis, lipemia, or other interrupting substances including blood and urine container are evaluated for interfering substances for each method performed. 12.5.6 Reference Range: Determine a reference range for each test following CLSI guideline C-23A. Samples used for the reference range study must be representative of the patient population being tested. Reference range assessment must be performed. Therapeutic range validation studies must be performed by vendor for applicable analytes, using CLSI protocols. Vendor to provide all reagents, calibrators, and controls needed along with technical assistance to perform correlation studies from a single lot at no additional cost for new test methods or changes in test menus, (i.e., vendor is to provide all manpower and reagents/supplies to do correlation studies). Carryover studies must be performed, as applicable, as part of the initial evaluation of the instrument(s). Vendor shall provide interpretation of raw data for each instrument installed and validate no carryover exists within the test platforms. 12.8 Upon completion of installation and validation/correlations, the equipment shall be turned over to BVAMC P&LMS for use. 12.9 Vendor shall provide equipment installation and possible reinstallation at minimal costs if the equipment is required to be moved due to construction or laboratory redesign 13. UPGRADES: 13.1 Upgrades or Replacement - Request for instrumentation upgrades or replacement, due to workload increase, excessive instrumentation failures/malfunctions, breakdowns, or service calls will be evaluated as needed/annually with communication to the vendor for modification of the contract. A high incidence of such problems with any equipment/analyzer supplied may indicate probable non-compliance with the terms of this contract and will entitle the facility/clinic to its replacement with another analyzer(s) that can produce the required criteria of this contract satisfactorily to the user. See Equipment Removal Requirement. 13.2 Upgraded Software/ Equipment - The Contractor shall provide all upgrades to the equipment hardware and operating system 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 enhancements shall be provided as they become available and at the same time as they are being provided to commercial customers. This only applies to system upgrades that enhance the model of the equipment being offered, i.e., new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, etc. This does not refer to replacing the original piece of equipment under the contract/order; however, it does refer to significant changes in the hardware operational capability. 14. OWNERSHIP OF EQUIPMENT: Ownership of the equipment shall remain with the contractor. All accessories furnished by the contractor shall accompany the equipment when returned to the contractor upon contract completion, or when replaced as specified herein, at contractor s expense. 15. EQUIPMENT REMOVAL: 15.1 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., as applicable) and shall be responsible for decontamination of the system, packing and shipping required to remove the analyzer. 15.2 The contractor shall remove all equipment within 30 days after notification of the expiration of the terms of this contract but not until the completion of new contractor s equipment installation inclusive of completed cross over studies. 15.3 Contractor shall not remove hard drive(s) from premises. All drives remain the property of VA. All service personnel shall be instructed regarding this requirement. NOTE: Prior to instrument removal, the hard-drive(s) must be removed in the presence of the BVAMC Information Security Officer (ISO) and retained by BVAMC OI&T for destruction according to BVAMC policy/procedure.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/BiVAMC521/BiVAMC521/VA24717N0731/listing.html)
 

Document(s)

Attachment
 

File Name: VA247-17-N-0731 VA247-17-N-0731.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3656719&FileName=VA247-17-N-0731-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3656719&FileName=VA247-17-N-0731-000.docx

 

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

Place of Performance

Address: Birmingham VA Medical Center;700 South 19th Street;Birmingham AL

Zip Code: 35233
 

Record

SN04578447-W 20170715/170713235420-8870e20e9cf3549ae18144c7709ec367 (fbodaily.com)
 

Source

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

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