Draft SOW_Chem IA_04142022.docx
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- 6640--Chemistry & Immunoassay Analyzer CPRR VISN
- Solicitation number
- 36C26122R0037
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Statement of Work (SOW) April 8, 2022
1. INTRODUCTION
VISN 21 – VA Sierra Pacific Healthcare System has a requirement for a Cost Per Reportable Results (CPRR) Indefinite Delivery, Indefinite Quantity (IDIQ) contract for clinical laboratory and immunoassay analyzers. The contractor agrees to provide a price schedule that shall encompass Cost Per Reportable Results (CPRR) Pricing structures only, in accordance with the terms and conditions of the SOW to the Veterans Integrated Service Network 21 (VISN 21), identified as the Government herein. The services and prices are specified in the sections entitled Schedule of Supplies/Services of this contract.
Period of Performance: five (5) years
Place of Performance: The scope of this contract covers the entire area of responsibility (AOR) of VISN 21, including any clinic. The Government will be free to add onto this IDIQ for any Community-Based Outpatient Clinic (CBOCs), clinics, etc. The addresses and locations may change, but the requirement applies to VISN 21.
1.1 Participating Facilities: Points of contact per facility are listed below.
STATION 459 PACIFIC ISLANDS
VA Pacific Islands Health Care System Department of Laboratory Service (113) 459 Patterson Road, Room 2-A03 Honolulu, Hawaii 96819 Point of contact: Jodi Liao - (808) 433-7619 - (Jodi.Liao@va.gov)
STATION 570 VA CENTRAL CA HEALTHCARE SYSTEM
VA Central CA Healthcare System 2615 E. Clinton Ave Fresno, CA 93703 Point of contact: William Walsh – (559) 225-6100 ext. 5719 – (William.Walsh5@va.gov)
STATION 612 NORTHERN CALIFORNIA HEALTH CARE SYSTEM
VA Sacramento Medical Center 10535 Hospital Way Mather, Ca 95655 Point of contact: Martha A Goodwin – (916) 843-7235 – (Martha.Goodwin@va.gov)
Martinez CBOC 150 Muir Road Martinez, CA 94553 Point of contact: Martha A Goodwin – (916) 843-7235 – (Martha.Goodwin@va.gov)
Redding CBOC 3455 Knighton Road Redding, CA 96002 Point of contact: Martha A Goodwin – (916) 843-7235 – (Martha.Goodwin@va.gov)
STATION 640 VA PALO ALTO HEALTHCARE SYSTEM
Chemistry B100-F4-160 VA Palo Alto HCS Building 50 Warehouse 3801 Miranda Ave, Palo Alto, CA 94304 POC: Lana Hur – (650) 493-5000 ext 66722 - (lana.hur@va.gov)
Livermore VA CBOC Building 65 Warehouse 4951 Arroyo Road Livermore, CA 94550 POC: Lana Hur – (650) 493-5000 ext 66722 - (lana.hur@va.gov)
STATION 654 VA SIERRA NEVADA HEALTH CARE SYSTEM
VA Sierra Nevada Health Care System 975 Kirman Avenue Reno, NV 89502 Point of contact: Tamara Mosley – (775) 784-3948 – (Tamara.Mosley@va.gov)
STATION 662 VA SAN FRANCISCO
VA Medical Center 4150 Clement Street San Francisco, CA 94121 Point of contact: Kristopher Taylor – (415) 750-2276 – (kristopher.taylor@va.gov)
Oakland CBOC 2221 Martin Luther King Way Oakland, CA 94612 Point of contact: Kristopher Taylor – (415) 750-2276 – (kristopher.taylor@va.gov)
STATION 593 VA SOUTHERN NEVADA HCS
| Medical Center – Las Vegas |
| 6900 N. Pecos Rd, North Las Vegas NV 89086 |
1.2 NCO 21 has provided estimated volumes of tests performed in Attachment A – Volume Estimates and Individual Test Pricing for each individual medical center and outpatient clinic laboratory. The Government estimates the volumes listed in the attached spreadsheet per facility but does not guarantee volumes as listed. Volumes may fluctuate up or down during the term of the IDIQ.
Types of Analyzers at each location:
| LOCATION |
| Chemistry |
| Immunoassay |
| Automation |
STATION 459 PACIFIC ISLANDS
| Honolulu, Hawaii 96819 |
| X |
| X |
| X |
STATION 570 VA CENTRAL CA HEALTHCARE SYSTEM
| Fresno, CA 93703 |
| X |
| X |
STATION 612 NORTHERN CALIFORNIA HEALTH CARE SYSTEM
| Mather, Ca 95655 (Medical Center) |
| X |
| X |
| X |
| Martinez, CA 94553 CBOC |
| X |
| X |
| Redding, CA 96002 CBOC |
| X |
| X |
STATION 640 VA PALO ALTO HEALTHCARE SYSTEM
| Palo Alto, CA 94304 |
| X |
| X |
| X |
| Livermore, CA 94550 CBOC |
| X |
STATION 654 VA SIERRA NEVADA HEALTH CARE SYSTEM
| Reno, NV 89502 |
| X |
| X |
| X |
STATION 662 VA SAN FRANCISCO
| Oakland, CA 94612 CBOC |
| X |
| San Francisco, CA 94121 |
| X |
| X |
| X |
STATION 593 VA SOUTHERN NEVADA HCS
| Las Vegas |
| X |
| X |
| X |
2. Required Specifications
2.1 General
· 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 perform the complete profile as described below and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (Hereafter referenced as CLIA) and the Clinical and Laboratory Standards Institute (Hereafter referenced as CLSI). Equipment shall be new, state of the art, and not recertified nor refurbished. Equipment shall be acquired for each of the clinical laboratories located at the following NCO 21 facilities: See Section 1.7.
· 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. 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 Contracting Officer Representatives (Hereafter referenced as COR). These individuals shall be identified upon award of the delivery order/s.
· 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.
· Industry Standards – Unless otherwise stated, all equipment shall be held to current industry standards for such equipment as present within the current market for Chemistry, Immunoassay, and automation equipment, supplies and services.
· Only instruments which are FDA approved will be considered. Instruments shall be operational and must interface with VA Laboratory Computer systems and upgrades.
· Test methods shall be FDA approved. Vendors with limited recalls due to product failures are preferred.
2.2 Definitions
Cost-Per-Reportable-Result (CPRR) – Contractors are required to provide a price for a reportable patient result. The per reportable result price shall include costs covering (a) equipment use, (b) all reagents, standards, controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the contractor’s equipment and necessary for the generation of a patient reportable result. This does not include those items approved for exclusion by the government such as printer paper, labels etc. This per patient reportable result price will also encompass all costs associated with dilution, repeat and confirmatory testing required to produce a single patient reportable result. It will also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by National Committee for Clinical Laboratory Standards (NCCLS). (c) All necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs and (d) training for Government personnel. Contractors are required to provide delivery, installation and removal of equipment at no additional charge.
Clinical Laboratory Chemistry Analyzer - Automated system for the robotic specimen handling and accurate analysis, data review, and reporting of human chemistry testing.
Clinical Laboratory Immunoassay Analyzer – Automated system for the robotic specimen handling and accurate analysis, data review, and reporting of human immunoassay testing.
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 be compatible with the primary analyzer, and shall meet all of 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.
Back-up analyzer – Equipment required to support the operations of the NCO laboratories when the primary analyzer(s) is not operational/functional. However, this equipment may also be used in conjunction with the Primary Analyzer to meet NCO program requirements as determined by the NCO, such as but not limited to “the simultaneous operation of both instruments to run additional testing as needed to meet program requirements.” This category of equipment must be capable of operation during periods of time when the primary instrumentation is not available for use. As such, the requirements for consumable supplies, i.e. reagents, quality control material, calibrators, etc., shall be reasonably comparable and system performance shall be corollary to the successful operation of the primary instrumentation. The back-up analyzer shall be of the same volume and speed rating as the Primary Analyzer or a comparable alternative that will allow the facility to continue operation at appropriate levels.
Business Associate Agreement (Hereafter referenced as BAA) -¬ A business associate is an entity, including an individual, company, or organization that, on behalf of the VHA facility, 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 everyone 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.
Community Based Outpatient Clinic (Hereafter referenced as CBOC) – CBOC’s are smaller facilities with smaller throughput than their larger parent facilities. Specific CBOC laboratories with test volumes listed in Attachment A – Volume Estimates and Individual Test Pricing will require equipment placements.
2.3 Chemistry Instrumentation:
The instrumentation offered shall provide the following capabilities:
| 1 | Provide clinical chemistry analyzer(s) with sufficient capacity and throughput to meet the volume and service demands as defined in the Test Menu (Attachment A – Volume Estimates and Individual Test Pricing. The vendor shall provide analyzer test throughput specifications for each proposed site installation. |
| 2 | Provide chemistry analyzers with consistent assay test methodologies for the purpose load balancing (workload) and back up purposes as indicated in the equipment list. |
| 3 | Closed Tube Sampling Capability. Instrumentation must have cap piercing or alternately offer a de-capping mechanism if no closed tube sampling is available. An external de-capping device is acceptable. Automated recapping of sample tubes for storage is preferred. |
| 4 | Complete test menu as specified on Attachment A or provide options such as third party reagent vendors to be used as “user defined assays” on the primary analyzer, if not available from the vendor. The offeror that is able to provide the most comprehensive test menu, instead of referring to “user defined assays” or third-party vendors, will be given additional consideration. If a second or backup analyzer is specified on the attachment, the backup or secondary analyzer must be manufactured by the same vendor receiving the award and must use the same reagents for each test to allow for standardized test builds. Placing a third-party vendor’s analyzer to meet test menu requirements is not acceptable. |
| 5 | Analyzer shall have automation and front-loading capabilities. |
| 6 | Chemistry analyzers connected to an automated track system must also be compatible with Immunoassay analyzers connected to the track system. Analyzers that are not connected to an automated track system must be physically connected and integrated Chemistry and Immunoassay systems (no separate units). |
| 7 | Walkaway capability. Reagents proposed for each analyzer must ensure that there is at least 24 hours of operational time before requiring replacement. Preference will be given to QC material that can be stored on board longer than 24 hours. |
| 8 | On board automatic dilutions with no technologist intervention or be able to automatically extend the dynamic range of the assay without technologist intervention. |
| 9 | Large onboard reagent capacity. The chemistry analyzer must have an onboard reagent capacity to perform all tests on the Test Menu (Attachment A – Volume Estimates and Individual Test Pricing with a minimal amount of reagent swapping. A minimal amount of reagent swapping is defined as less than 5 assays in the menu on Attachment A – Volume Estimates and Individual Test Pricing. The onboard capacity reagent volume should support a 24-hour walkaway capability. |
| 10 | Shall be space efficient and can be installed within the existing floor space with no reconstruction or minimal construction. There will be an opportunity for offerors to visit each site to evaluate space needs; or floorplans will be made available upon request. The equipment proposed must accommodate workflow to ensure easy access to other parts/departments of the laboratory and construction shall be at the vendor’s expense. |
11. Perform the creatinine, hemoglobin A1C and cholesterol assay testing using a method referenced to an international standard (e.g., WHO standard). If the methodology changes and warrants patient re-baselining, the vendor shall provide necessary services and materials.
| 12 | Must have minimal reagent preparation and equilibration. 90% of the vendor’s reagents must be fully liquid and ready to use without reconstitution. Minor reagents transfer for activation is acceptable. |
| 13 | Shall have the capability to add additional assays as they become available. |
| 14 | Must use Ion Selective Electrode (ISE) technology for the measurement of electrolytes. An enzymatic method for CO2 will be acceptable if an ISE method is not available. |
| 15 | Shall be capable of flagging expiring reagents and calibrations. Must allow quality control (QC) data viewing and report extraction (e.g., Levey Jennings charts, running means & SD’s, etc.), have the ability to retrieve historic QC, reagent, control, and calibrator data for troubleshooting. Preference will be given to databases that store this information for longer periods of time. |
| 16 | Shall have bidirectional interface capabilities. |
| 17 | Must have a minimum of 20 facilities reporting in peer groups for QC programs and the College of American Pathologists (CAP) Proficiency Test Program. Ability to export and upload QC data in real time to peer group program. |
| 18 | Analyzer shall have the capability to perform serum indices, defined as the qualitative assessment of lipemia, icterus, and hemolysis. |
| 19 | Ability to detect fibrin or clots and short samples during sample aspiration. |
| 20 | Ability to generate Critical and/or abnormal result flags. |
| 21 | Analyzer shall have test methods and /or procedures equivalent to standard reference methods, with high preference for international standardization when possible. |
| 22 | Ability to accept multiple tube sizes, such as 13X100mm, 13X75mm, 16X100mm. |
| 23 | Each analyzer or data manager shall have the ability to store and retrieve patient data for at least 30 days. |
| 24 | Shall have the ability to prioritize STAT testing over routine testing. Preference will be given to systems that can prioritize STAT samples with the least amount of technologist intervention. |
| 25 | Vendor shall maintain an adequate replacement part inventory locally to minimize downtime associated with transporting parts to analyzer site. An adequate inventory would include parts that are known/could need to be changed frequently and should be kept either on-site or locally in a storage facility. Sufficient parts for routine maintenance shall be kept onsite. |
| 26 | If the analyzers require a water system, the vendor shall install and maintain an appropriately sized water system for the duration of the contract at the vendor’s expense. The water system is to provide an acceptable quality and quantity of water to the analyzers according to the required specifications. |
27. Equipment shall be provided with an Uninterruptible Power Supply (UPS). If possible, provide a single UPS with the capacity to maintain continuous operations for 2 hours.
28. The contractor has the capability to establish a remote connection for the purpose of instrument troubleshooting, software updates, and delivering test volumes for invoice generation.
29. Calibration frequency not to exceed once per 24 hours per instrument for ISE.
30. Long calibration stability preferred for all other testing.
31. Shall have the ability to pre-calibrate new lots of reagents prior to use.
32. Quality control testing requirement frequency not to exceed once per 24 hours per instrument.
33. Ability to lock out/suppress test analytes if there are QC failures.
34. No requirements for sample pre-treatment.
35. Preference will be given to chemistry STAT test results that can be available within 15 minutes from the time it is loaded on the analyzer to the time results are available.
Test volumes are listed by facility in Attachment A – Volume Estimates and Individual Test
2.4 Immunoassay Instrumentation
The instrumentation offered shall provide the following capabilities:
1 Provide immunoassay analyzers with consistent methodology for load balancing (workload) and back up purposes as indicated in the equipment list. If a second or backup analyzer is specified on the attachment, the backup or secondary analyzer must be manufactured by the same vendor receiving the award and must use the same reagents for each test to allow for standardized test builds. Placing a third-party vendor’s analyzer to meet test menu requirements is not acceptable.
| 2 | Ability to aspirate the sample and release the tube, so additional testing can be run without delays. |
| 3 | Perform the Prostate Specific Antigen (PSA) assay testing with consistency for patient testing using the hybritech method or the WHO standard with optional free PSA. If the methodology changes warrant patient re-baselining, the vendor shall provide necessary services and materials. |
| 4 | Perform Free T4 using a two-step method to reduce bias from euthyroid sick patients or with patients with familial dysalbuminemic hyperthyroxinemia for consistency and patient testing. |
| 5 | Provide analyzer(s) with sufficient capacity and throughput to meet the volume and service demands as defined in the Test Menu (Attachment A – Volume Estimates and Individual Test Pricing. The vendor shall provide analyzer test throughput specifications for each proposed site installation. |
| 6 | The analyzer must be compatible with the automation line for connectivity (only for those sites choosing automation) |
| 7 | The analyzer shall be able to connect to the provided data management system along with the Chemistry analyzers in order to consolidate lab test results and allow the ability to schedule repeat testing directly from the Data Management System. |
| 8 | Each analyzer or data manager shall have the ability to store and retrieve patient data for at least 30 days. |
| 9 | Analyzer and or data management system shall have Reagent and Control lot monitoring capabilities. |
| 10 | Shall be capable of flagging expiring reagents and calibrations. Must allow quality control (QC) data viewing and report extraction (e.g., Levey Jennings charts, running means & SD’s, etc.), have the ability to retrieve historic QC, reagent, control, and calibrator data for troubleshooting. Preference will be given to databases that store this information for longer periods of time. |
| 11 | The analyzer onboard reagent storage must accommodate those tests specified on the data usage spreadsheet (Attachment A – Volume Estimates and Individual Test Pricing). |
| 12 | The analyzer shall have bidirectional interface capability. |
| 13 | The analyzer shall contain electronic trouble shooting software for instrument errors. |
| 14 | Analyzer shall have minimal reagent preparation. 90% of reagents, calibrators, and controls (if available), are liquid ready-to-use with minimal to no equilibration time from storage prior to use on the analyzer. |
| 16 | Analyzer shall have Fibrin and/or clot detection, in addition to short sample detection. |
| 17 | Shall have Critical and/or Abnormal result flagging. |
| 18 | Analyzer shall be provided with an Uninterruptible Power Supply (UPS) |
| 19 | Analyzer shall have test methods and /or procedures equivalent to standard reference methods. |
| 20 | Vendor shall maintain an adequate replacement parts inventory locally to minimize downtime associated with transporting parts to analyzer site. A listing will be provided to the facility upon request. |
| 21 | If the analyzers require a water system, the vendor shall install and maintain an appropriately sized water system for the duration of the contract at the vendor’s expense. The water system is to provide an acceptable quality and quantity of water to the analyzers according to the required specifications. |
| 22 | Preference will be given to assays that avoid using known interfering substances such as biotin. If assays use biotin the specific information must be provided on potential impact to patient results. |
| 23 | Analyzers should be capable of performing a wide range of infectious disease testing. Including, but not limited to HIV, Hepatitis B, and Hepatitis C testing (refer to attachment A). Preference will be given to analyzers that prevent sites from managing multiple immunoassay contracts to provide this testing. |
24. High/Ultra-sensitive reagent-based assays shall be utilized, alleviating interferences.
25. Immunoassay high/ultra-sensitive PSA and TSH tests, prefer incubation times not to exceed 20 minutes to maintain or improve turnaround times.
26. STAT Immunoassay incubation times not to exceed 10 minutes, to meet chest pain center accreditation requirements and maintain or improve current turnaround times.
27. Prefer immunoassay incubation times not to exceed 30 minutes, to meet or exceed current turnaround times.
28. A Troponin which meets the IFCC definition of high sensitivity i.e., can be detected in at least 50% of normal reference population.
29. Disposable sample pipette tips to eliminate carryover risks.
| 2.5 | Power for Chemistry and Immunoassay: |
| 1. | Individual components shall not require more than 30 amps, 110V or 220V. It is acceptable for peripheral equipment such as the monitor, computer, and printer, to be plugged into separate outlets or UPS |
| 2. | Shall provide back-up UPS power for each analyzer/component. |
| 3. | Shall be installed within the existing power capability that exists for each laboratory, regarding both emergency and normal power. |
2.6 Automation for Chemistry and Immunoassay:
| 1. | Analyzers shall be capable of adding automation connectivity for future requirements during the term of the delivery order/s. Any additions will be negotiated and require the signature of the CO and delivery order/s contract holder. |
| 2. | The automation system will perform centrifugation, sorting, and load balancing to the analyzers, decapping, recapping or sealing the specimen, and placing the specimen into a refrigerated storage unit. It is preferable but not required that an automated specimen disposal feature is available. |
| 3. | Ability to store a minimum of 5000 or more samples in an online refrigerated storage unit for more than 24 hours. Add on test requests will be processed with the refrigerated storage unit reintroducing the sample back on the line for testing with minimal operator intervention. |
| 4. | The Automation centrifuge must have adequate Relative Centrifugal Force (RCF) to accommodate a six minute or less centrifugation time to provide sufficient separation of serum or plasma from its cellular constituents for testing with analyzers connected to the automated track or if taken off the track for testing or to be sent out to a referral lab. |
| 5. | Specimens shall be mapped by the automation software to allow quick automated retrieval from the refrigerated storage unit. |
| 7. | Ability for the automation and analyzers to be installed within the existing floor space. Individual laboratory floorplans will be made available upon request. |
| 8. | Ability to simultaneously accept pre-spun and non-spun samples for processing. |
| 9. | The automation system shall be compatible with the chemistry and immunoassay instrumentation selected on this solicitation. The automation system must process those samples with the required tests listed on Attachment A for both Chemistry and Immunoassay. Additional consideration will be given to the vendor that can provide an automation system that is able to process those tests listed as “preferred but not required”. |
| 10. | Vendor is to provide and install a suitable compressed air system sufficient for the automation system if needed. |
12. Automation with input sorting technology (such as a hopper) and the ability to aliquot are preferred characteristics.
13. The contractor has the capability to establish a remote connection for the purpose of instrument troubleshooting, software updates, and delivering test volumes for invoice generation.
| 14. Ability to make bar code labeled aliquot tubes that mirror the primary tube labeling for |
| offline processing. |
15. De-capper shall have the ability to remove different cap types (e.g. hemogard, screw caps, rubber stoppers). This is necessary to maintain employee safety by reducing the exposure to body fluids and maintain workflow and turnaround time.
16. Uncapping and recapping/sealer system in an enclosed environment to prevent distribution of bio-hazardous aerosols.
2.7 Data Management for Chemistry and Immunoassay:
| 1. | The Data Manager will display real-time list of pending results that can be sorted by STAT vs. Routine. |
| 2. | Ability to consolidate lab test results from Chemistry and Immunoassay testing analyzers and transmit the consolidated results to the Lab Information System. |
| 3. | Monitor Quality Control Results for all connected instruments. |
| 4. | Has the capability to perform real-time moving averages and stop patient result uploading if QC or averages exceed established limits. |
| 5. | Ability to perform rerun testing or add on testing thru the Data Management system. |
| 6. | Ability to install validation rules for auto validation purposes on vendor middleware. |
| 7. | Preferred offer will have remote display and interaction with analyzers for operations, to include error messages and reagent inventories. |
| 8. | Updates to Data Management software are provided at no additional charge when they become available. |
| 9. | Shall provide license(s) and hardware if needed for Data Innovations or other middleware at no additional charge to the VA. |
| 10. | The contractor has the capability to establish a remote connection for the purpose of instrument troubleshooting, reagent management, software updates, and delivering test volumes for invoice generation. In order to accomplish this the contractor must have an ISA/MOU is established with the VA OI&T (Office of Information and Technology) to allow for the implementation of remote diagnostics connectivity. All connectivity hardware and installation is provided by the vendor. |
11. Listed as preferred but not required: Will automatically calculate and report to the LIS both Free and BioAvailable Testosterone, using values from Total Testosterone, Albumin, and Sex Binding Globulin Hormone.
12. Shall have the capability to transmit QC data to an external real-time QC service.
2.8 Software for Chemistry and Immunoassay:
| 1. | Shall have QC monitoring software. |
| 2. | Shall have online help and maintenance tracking capabilities and have service/downtime record for troubleshooting information. |
| 3. | Software upgrades shall be compatible and require no or minimal changes to existing Laboratory Information System (LIS) |
3. Installation/Site Preparation:
1. Site preparation specifications for each facility shall be furnished in writing by the Contractor as a Site Preparation Report after award of the delivery order/s. The report shall be provided to the Contracting Officer no later than one week after award of the delivery order/s and all other site reports shall be provided at least forty-five (45) days before installation of all other sites. Contractor shall visit each site and propose the location of equipment and determine specific site prep requirements (before the bid) including but not limited to:
· Space availability
· Power availability
· Availability of waste drainage systems
· Increase heat load affecting air conditioning
· Specialized ventilation if required
· Special finishes required
· Carts for non-floor standing instrumentation
All proposed equipment must fit in the available lab space without construction modifications. Minimal construction may be considered if approved by the engineering department at the site. If site visit is not acceptable, bidding contractor will be provided with floor plans, requirements, measurements.
Mather: New laboratory will be renovated during the life of this contract and the initial installation of instrumentation will need to be moved to a temporary location, and then to a final location (and revalidated). All bids should include the costs for the moves for moving the equipment at Mather to a temporary location, and then to a final location.
| 2. | Equipment shall be new, state of the art, and not recertified or refurbished. |
| 3. | 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 contract and required to establish instruments for operation for performance of acceptance testing. |
| 4. | 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 additional cost to the Government. |
| 5. | The Contractor shall perform all of the statistical analysis for the instrument validation and report data in a format that meets regulatory requirements. |
4. Service and Maintenance
| 1. | The Contractor shall provide equipment repair and preventative maintenance on all primary and back-up instrumentation and any incremental support equipment, e.g., water system, covered under the delivery order/s award, and UPS. |
| 2. | Support Services: Contractor shall provide telephone assistance 24-hours/day, 365 days per year with a call back response of 2 hours. Following determination that service is required, technical on–site support shall be provided under the terms of the contract and provide for emergency repairs 365 days per year within twenty-four (24) hours of the time of notification of the malfunction for medical center labs. For CBOC labs, during normal operating hours, within twenty-four (24) hours of the time of notification of the malfunction. If both primary(s) and backup analyzers are not able to perform a test listed as STAT, Contractor shall have defined, approved contingency plan to ensure continuation of testing. The Contractor shall provide maintenance (labor and parts) 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. |
3. The contractor shall furnish a malfunction incident report to the installation upon completion of each repair call. The report shall include, as a minimum, the following: (a) date and time notified; (b) date and time of arrival; (c) serial number, type and model number(s) of equipment; (d) time spent for repair; (e) description of malfunction and repair; and (f) proof of repair that includes documentation of quality control being performed and within range, as applicable. Must notify the site management if repair is significant enough to require calibration and/or validation following the repair and vendor shall perform calibration and/or validation.
4. Maintenance plan: Contractor shall provide manufacturer’s daily, weekly, monthly, quarterly and periodic maintenance plan, outlining time required for hands on and automated tasks.
5. Daily maintenance: Instrumentation shall require minimal hands-on daily maintenance.
6. Preventative Maintenance: Contractor shall provide regular, scheduled maintenance coordinated with the site management 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.
7. Emergency Repair: 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. The Contractor shall provide all parts and labor needed to repair the malfunction. Travel, per diem and other expenses associated with the repair shall be borne by the Contractor. The Contractor shall furnish a malfunction incident report to the installation upon completion of each maintenance call. The report shall include, as a minimum, the following: (a) date and time of arrival. (b) Serial number type and model numbers(s) of equipment (c) time spent for repair, (d) description of malfunction and (e) proof of repair.
8. Maintenance Support: Service repair person locally based within the geographical area.
9. Maintenance Credit for Equipment Malfunction: If a machine remains inoperative due to a malfunction through no fault or negligence of the government for more than 24 hours, 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. 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.
10. 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.
11. 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.
12. Upgrades or Replacement: Request for instrumentation upgrades or replacement, due to workload increase, menu changes, technological upgrades, excessive instrumentation failures/malfunctions, breakdowns, or service calls will be evaluated as needed/annually with communication to the Contractor for modification of the contract. A high incidence of 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. Removal of instrument by the Contractor shall be performed within 60 days after request.
5. Training
1. 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 this 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 at a minimum for one operator per installed analyzer per year at the discretion of the Government for each model of instrumentation or automation 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. Onsite Training: During the validation process of the installation, the vendor shall provide technical resources to train operators on all shifts of operation. This can be accomplished by holding training sessions for multiple employees on each shift.
3. In addition to the training above the following shall be provided:
(1) Advanced training, either off-site or in-house, shall be provided on instrument troubleshooting, advanced middleware rules writing, data analytics, report writing and customization
(2) On-site refresher training in renewal option years of the contract shall also be made available annually.
4. In addition, the Contractor shall provide supplemental on-site operator training to government personnel, without additional charge to the government, upon installation of upgraded equipment hardware or operating system software connected with the operation of an instrument that has already been installed.
6. Upgrade/Updates
1. The Contractor shall provide updates 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 upgrades 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 updates” that enhance the model of equipment being offered, i.e., new version of software, correction of hardware defect, update 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 delivery order/s; however, it does refer to significant changes in the hardware operational capability. Should any facility decide to upgrade their current equipment, i.e., replace existing equipment with newer models, the CO and Contractor may do so under a signed supplemental agreement.
7. Information Technology
· A VA Directive 6550 – Appendix A shall be completed for each analyzer offered under the solicitation.
· Primary and back-up instrument interfacing is required at all sites. The current type of interface system is Data Innovations.
| • | The Contractor shall be responsible for providing all hardware and software licenses required for the connection, and implementation of the analyzer’s interface to the Laboratory’s Universal Interface. |
| • | The Contractor shall provide all necessary software support for ensuring 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. |
· The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and shall assist in regulatory compliance, e.g., electronic procedure manual
· The contractor shall have the capability to establish a remote connection for the purpose of instrument troubleshooting, reagent management, software updates, and delivering test volumes for invoice generation. In order to accomplish this the contractor must have an ISA/MOU is established with the VA OI&T (Office of Information and Technology) to allow for the implementation of remote diagnostics connectivity. All connectivity hardware and installation is provided by the vendor.
8. Ancillary Support Equipment
1. The Contractor shall provide, install and maintain, as indicated, any and all ancillary support equipment to fully operate the analyzer or automation as defined in these specifications, e.g., cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, etc.), compressed air, and universal interface equipment, UPS, 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.
9. Packaging and Marking
1. All supplies shall be adequately packaged to prevent damage during shipping, handling and storage. Bags or packages shall be whole, intact, and not otherwise torn or damaged. The Contractor shall be required to replace unacceptable or damaged products at the Contractor’s expense.
2. All items shall be marked clearly with the delivery order number, purchase order number, and delivery location within the hospital i.e., Laboratory Services/113.
10. Installation/Implementation
1. PHASE-IN/PHASE OUT REQUIREMENTS - Due to the length of time required to implement the requirements.
2. Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 180 days after the award of the delivery order/s. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. Contractors shall not be penalized for implementation timelines that extend beyond the 180-day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government (i.e., construction/ remodeling of facilities). Upon award of a delivery order/s, the transition period for the awarded Contractor to have all equipment and peripherals installed and operational shall be 120 days from the date of award through 180 days. This requirement includes the implementation of autoverification and the transmission of QC data to an external real-time QC service. During this same period, all initial training of VA personnel in the operation and maintenance of said award shall also be completed with exceptions due to delays at the fault of the Government.
3. The new contractor/vendor must be able to coordinate with the laboratory and install the new equipment while the old contractor’s equipment is still in operation in order to prevent any lapse of service for laboratory testing.
4. At the end of 180 days from award of the Contract, the awarded Contractor shall have full and sole responsibility for services under the awarded delivery order/s.
5. Within one week from the date of award of the delivery order/s, the CO, CORs and the Contractor shall establish a kickoff meeting to discuss implementation.
6. Acceptance and Performance – This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the delivery order/s 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. Acceptance will occur once the analyzers/equipment have met the standard performance for a period of 30 consecutive calendar days by operating in conformance with the Contractor’s technical specification or as quoted in the contract at an effectiveness level of 90% or more.
7. Start-Up Reagents - The Contractor shall provide all reagents, calibrators, controls, consumable items, disposable items, parts, accessories, and any other item included on the list of supplies defined in the contract and required to establish instruments for operation for performance of acceptance testing. The Contractor shall perform, to the satisfaction of the Government, all validation studies including precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, carryover studies, verification of reference interval, and determination of sensitivity and specificity at no cost to the Government.
8. 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.
9. If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the Government may request a replacement or terminate the delivery order/s in accordance with the provisions of FAR 8.406-4 “Termination for cause.” (The Contractor shall receive revenue for tests reported during the 90-day acceptance period.).
10. 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.
11. 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.
12. 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.
11. Replacement of Malfunctioning Equipment
1. During the term of the delivery order/s, should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the designated representative of the Government to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer’s instructions, shall be solely that of the Contractor. Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the agreement.
12. Delivery
1. The Contractor shall deliver all supplies and services identified in the schedule to the locations identified in Section 1.7.
2. The delivery location is subject to change as required by the designated authority or authorized personnel at the receiving facility. The Contracting Officer Representative (COR) shall be required to notify the Contractor when delivery locations have been changed.
3. All deliveries shall be made during normal working hours from 8:00 a.m. to 4:00 p.m. and a copy of the packing list/slip shall be provided at time of delivery. The packages packing list/slip shall contain the complete purchase order number, delivery order number, shipping address, delivery location, items/quantity ordered, and items/quantity shipped.
4. Standard orders shall be delivered within no more than 4 working days after receipt or placement of order. Emergency deliveries may be necessary on rare occasions. During these occasions, deliveries shall be made within one (1) working day if the order is place before 10:30 am. Otherwise, the emergency deliveries shall be made no later than two (2) working days from the time the order was placed. Emergency deliveries shall be made at no additional cost to the government.
13. Government’s Responsibility
1. The user shall 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.
14. Ownership of Equipment
1. 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 at the expense of the Contractor. The Contractor shall disconnect the analyzer (gas, water, air, etc.) and shall be responsible for all packing and shipping required to remove the analyzer.
15. Equipment Removal
1. Following the expiration of this contract, the Contractor shall remove all equipment…
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