Sources Sought-36C24726Q0872.pdf

Sources Sought Notice

*= Required Field Sources Sought Notice

SUBJECT* CPRR Base + options-Augusta VA Medical Center

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE* 30084

SOLICITATION NUMBER* 36C24726Q0872

RESPONSE DATE/TIME/ZONE 08-26-2026 0800 EASTERN TIME, NEW YORK, USA

ARCHIVE 15 DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS N

SET-ASIDE

PRODUCT SERVICE CODE* Q301

NAICS CODE* 541380

CONTRACTING OFFICE ADDRESS Department of Veterans Affairs

VISN 7 Network Contracting Office LaVista Business Park - Bldg A 2008 Weems Road Tucker GA 30084

POINT OF CONTACT*

Davida Lee Davida.Lee@va.gov

PLACE OF PERFORMANCE

ADDRESS Augusta VA Medical Center 1 Freedom Way Augusta, GA 30904

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

This is not a solicitation announcement. This is a sources sought synopsis for market research purposes

ONLY. The purpose of this synopsis is to gain knowledge of potential qualified vendors that can provide the following:

FDA approved automated integrated track system, including chemistry analyzers, immunoassay analyzers, 2 centrifuges, decapper, and input module. In order to reduce the risk of paying additional “add-on” costs associated with a bundle price when test volumes increase, the VA requires vendor financial proposals to be structured as follows:

*CPRR to include reagents, controls, calibrators, consumables and accessories.

*Fixed rental for instruments, all automation components and middleware, complete system installation and integration, on-going service for each and water system hardware and service, complete training for personnel for the term of the agreement

This requirement is relative to NAICS 541380 (Testing Laboratories and Services) (size standard of

$19.0 Million). Responses to this synopsis will be used by the Government to make appropriate acquisition decisions. After review of the responses to this source sought synopsis, a solicitation announcement may be published in SAM.gov. Responses to this sources sought synopsis are not considered adequate responses to the solicitation announcement. All interested offerors will have to respond to the solicitation announcement in addition to responding to this source sought announcement. The Department of Veterans Affairs, Network 07 Contract Office, is seeking sources to provide:

Cost Per Reportable Result Service for the Augusta, GA VA Medical Center

If you are interested and can provide the required supplies, please provide the requested information as indicated below.

All RFI’s must provide the following information in this format:

1. Company Name:

Address:

Phone Number:

2. Point of Contact:

Email:

Phone Number:

3. Company Unique Entity ID (Found at SAM.GOV)

4. Company Business Size (Large, SDVOSB, Small etc.)

All RFI’s must provide the answers to the following questions:

(1) Is your company considered small under the NAICS code identified under this RFI?

(2) Please provide general pricing for your /solutions for market research purposes.

(3) Please submit your capabilities regarding the Performance Work Statement to establish capabilities for planning purposes.

Responses to this notice shall be submitted via email to: Thomas.Nicholls@va.gov

Telephone responses will not be accepted. Responses must be received no later than 08/26/2026 at

08:00 AM EST. If a solicitation is issued, it shall be announced later, and all interested parties must respond to that solicitation announcement separately from the responses to this request for information.

Responses to this notice are not a request to be added to a prospective bidders list or to receive a copy of the solicitation.

Statement of Work

Charlie Norwood VA Medical Center

Augusta GA 30901

Cost Per Reportable Results (CPRR)

1. GENERAL INFORMATION

Introduction

1.1 The contractor shall provide the Charlie Norwood Veterans’ Hospital (VA), Pathology and

Laboratory Medicine Service an FDA approved automated integrated track system, including chemistry analyzers, immunoassay analyzers, 2 centrifuges, decapper, and input module. In order to reduce the risk of paying additional “add-on” costs associated with a bundle price when test volumes increase, the VA requires vendor financial proposals to be structured as follows:

*CPRR to include reagents, controls, calibrators, consumables and accessories.

*Fixed rental for instruments, all automation components and middleware, complete system installation and integration, on-going service for each and water system hardware and service, complete training for personnel for the term of the agreement.

In addition, the contractor shall provide an integrated system and deionized water system for

Charlie Norwood Veterans’ Hospital to be included in this agreement. The successful contractor is expected to meet the needs of today and have the flexibility to easily adapt to future test menus and volumes. See attachments for test volumes at each facility.

1.1.1 Background:

1.1.2 The Charlie Norwood VA Medical Center is a two division multi-bed facility, encompassing acute medical, surgical, psychiatric, and long-term care. The hospital is located in

Augusta, Georgia and provides primary, secondary, and some tertiary care. It is the intent of the

Charlie Norwood VA Medical Center to establish a contract for a highly automated, compact modular system which monitors microbial growth continuously from blood samples and other normally sterile body fluid samples.

1.2 Acronyms:

1.2.1. STAT – Statim (immediately)

1.2.2. FDA – Food and Drug Administration

1.2.3. CAP - College American Pathologist

1.2.4. CV – Coefficient of Variation

1.2.5. QC Program – Quality Control Program

1.2.6. VISTA – Veterans Information Systems and Technology Architecture

1.2.7. HIPAA – Health Insurance Portability and Accountability Act

1.2.8. CLSI – Clinical Lab Standard Institute

1.2.9. CDR – Contract Discrepancy Report

1.2.10. CAD - Computer Aided Design

1.2.12. CNVAMC – Charlie Norwood VA Medical Center

1.3 Publications and Forms:

1.31. VA Directive 6500, Information Security Program

1.4. OPERATION:

1.4.1. DAYS AND HOURS OF OPERATION:

24 hours a day 7 days a week including Federal Holidays.

Federal Holidays

New Year’s Day - January 1st

Martin Luther King’s Birthday - 3rd Monday in January

President’s Day - 3rd Monday in February

Memorial Day - Last Monday in May

Independence Day - July 4th

Labor Day - 1st Monday in September

Columbus Day - 2nd Monday in October

Veteran’s Day - November 11th

Thanksgiving Day - Last Thursday in November

Christmas Day - December 25th

Period of Performance: One Base Year with four one-year option periods.

Base Year: October 1, 2026 – September 30, 2027

Option Year 1: October 1, 2027 – September 30, 2028

Option Year 2: October 1, 2028 – September 30, 2029

Option Year 3: October 1, 2029 – September 30, 2030

Option Year 4: October 1, 2030 – September 30, 2031

2. PERSONNEL:

2.1. Qualification:

2.1.1. Contractor’s service representatives shall be factory trained and have a minimum of 2 years’ experience working on contracted equipment.

2.1.2. All contractors’ representatives shall be sufficiently fluent in the English language to effectively communicate with Charlie Norwood VA Medical Center’s representatives.

3. SCOPE OF WORK

3.1. General: The offeror shall provide to Charlie Norwood Veterans’ Hospital all supplies and services as described herein to perform Clinical Chemistry and Immunochemistry testing.

3.1.1. Cost per Reportable Result: CPRR is an all-inclusive price. The contractor is required to furnish all reagents and supplies necessary to operate the contractor’s equipment for the testing menu as defined: including calibrators, serum indices, linearity materials, consumables, and any accessories required for operating all analyzers and equipment.

Once service is determined to be required, technical on-site support must be provided under the terms of the Federal Supply Schedule, including emergency repairs within 24 hours of notification.

3.1.2. Testing Menu: Vendor shall meet the test menu demands as defined in Attachment 1.

Test menu requirement may be met by using, within reasonable limits, alternate FDA approved reagents adapted to the proposed analytical solution. Annual test volumes provided with this contract are based upon prior history and are not guaranteed at a minimum. New test will be added, as requested, to the menu with all the reagents for test validation supplied at no additional cost. Specimen integrity checks shall be made on all specimens and no additional charge.

3.1.3. Charlie Norwood Veterans’ Hospital: See attachments for individual test volumes.

3.1.4. Additional Requirements: The vendor must write the SOP (Standard Operating

Procedures) for the test menu provided in the Charlie Norwood Veterans’ Hospital template format.

4. Requirements of Services to be provided:

4.1. Basic Requirement:

4.1.1. The system must contain random access technologies that improve workflow. The system must be callable on site to accommodate anticipated increases in workload and to acquire improved technology. The system must fit in with the current space available.

4.2. Chemistry Analytical Systems for Charlie Norwood Veterans’ Hospital:

4.2.1. Expected throughput: Ability to manage testing workflow of hospital. Analytical configuration of chemistry platforms must provide for backup analyzer(s) with equivalent menus utilizing the same reagent formulation to ensure correlation among instruments. Analyzers for the Charlie Norwood Veterans’ Hospital must have a combined minimum throughput of 1000 tests per hour to meet current practice.

4.2.2. Specimen integrity evaluation on all samples as needed to no additional cost.

4.2.3. Can repeat and reflex test, auto-rerun and auto-dilute.

4.2.4. Acceptable reagent capacity – Minimum 60 reagent positions per chemistry analyzer to meet current practice

4.2.5. Integrated high laboratory grade water system with provision for uninterrupted water supply during maintenance/change over. (E.g. de-ionized water used for all analytic platforms).

Maintenance and service (including all emergency services) to be provided 24/7 at no additional cost to the facility. Per The Joint Commission: Vendor will be responsible for covering all costs associated with maintaining the water systems and providing water to the analyzers that require it for the duration of the contract. Also, the vendor will assume all costs for the acquisition and storage of water. The acquisition must include water quality indicators, back up water system and 24-hour emergency repairs. The DI water system must meet CLIA safety standards.

4.2.6. STAT test results are available in <10 minutes from the time loaded on the analyzer to the time results are available. Stat loading available on instruments with polarization of STAT over routine testing. STAT testing should have the ability to jump in front of all routines and not wait on samples previously loaded.

4.2.7. Minimal calibration requirements for all tests; ensure ease of calibration with extended calibration stability and minimal calibration frequency. Please list calibration frequency for all assays. Calibrators should be liquid and ready to use, direct from storage.

4.2.8 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.

4.2.9 Quality methods with CV acceptability on College American Pathologist (CAP)

Proficiency testing evaluations.

4.2.10 Quality control frequency not to exceed once/24 hours/instrument platform. Minimum quality control frequency for NA/K/CL does not exceed once/24 hours/instrument platform.

4.2.11 Reagent must be able to be loaded while instrument is in operation without waiting for them to come to room temperature.

4.3. The analyzers must have a comprehensive QC Program for all tests which includes at minimum the following options:

4.3.1. QC files may be edited or corrected for errors manually

4.3.2. On-board quality control data storage and reporting capabilities

4.3.3. Ability to view and print daily and monthly QC results

4.3.4. Ability to view and print Levy Jennings graphs

4.3.5. On-line documentation of out-of-range QC

4.3.6. Read barcoded QC

4.3.7. Westgard rules built in

4.3.8. Open channel availability for adaptation of commercially available reagents not produced by vendor, without charge from vendor for use.

4.3.9. Minimum number of factories recalls of reagents and instrumentation. Please include all factory recalls for the last 18 months.

4.3.10. Minimum daily, weekly, and monthly maintenance downtime. Please provide total maintenance times, including washes and wait times for daily, weekly, and monthly maintenance. Please include any hands-on, automated non-maintenance activities.

4.3.11. Intuitive inventory manager on board to be able to assess user’s use of reagents and provide recommended re-supply levels.

4.3.12. Vendor to provide all utility requirements to operate all equipment.

4.3.13. Vendor to provide average number of service calls per year per analyzer.

4.3.14. Analyzer to accommodate a universal carrier system and multiple tube types.

4.3.15. Instrument sample clot detection. Please describe how analyzer detects.

4.3.16. Test menu as defined in attachments.

4.4. Immunochemistry Analytical Systems for Charlie Norwood Veterans’ Hospital:

4.4.2. Expected throughput: Ability to manage high a volume laboratory with minimal number of analyzers, configured to fit into existing allotted space. Analyzers for the Charlie

Norwood Veterans’ Hospital must have a combined minimum throughput of 600 tests per hour to meet current practice.

4.4.3. Acceptable reagent capacity – Minimum 48 reagent positions per chemistry analyzer to meet current practice

4.4.4. Minimum of two Immunochemistry analyzers, with same reagent platform, provided for

Charlie Norwood Veterans’ Hospital.

4.4.5. Reagents must be able to be loaded while instruments are in operation without waiting for them to come to room temperature.

4.4.6. Full spectrum of current immunochemistry test menu – see menu requirements and test counts in attachments.

4.4.7. Stat immunoassay reaction times not to exceed 10 minutes, to meet or exceed current turnaround times.

4.4.8. Immunoassay reaction times are not to exceed 30 minutes to meet or exceed current practice.

4.4.9. Minimal daily, weekly, and monthly maintenance downtime. Please provide total maintenance times, including washes and wait time, for daily, weekly, and monthly maintenance.

4.4.10. Quality methods with CV acceptability on CAP Proficiency testing evaluations.

4.4.11. Quality control frequency does not exceed once/24 hours/instrument platform.

4.4.12. Carryover should be minimized on board through technologies decreasing the need for consumables

4.4.13. Vendor to have capability of larger test kits sizes to minimize reagent change outs.

4.4.14. Instruments must have ability to use short samples on track.

4.5. Automation System – Pre/Post Analytic Line Processing for Charlie Norwood

Veterans’ Hospital:

4.5.1. Vendor to supply system that records arrival time, directs the scheduling, routing, and tracking of specimen carriers on the conveyor system from loading to the final disposition.

The information system component of this laboratory automation system must be able to communicate with Hospital Information System to the system manager and shall include and not be limited to: order code or name, tube type, accession number, container id, and receipt date and time.

4.5.2. Vendor to provide non-linear or linear configuration of conveyor system for transportation of specimens to analyzers for optimal space utilization in lab and minimal disruption of current workflow and space. Pre/post analytical processor must fit within currently allocated space. Current space is limited by support columns and access hallways in the laboratory and defined in an area that is 36’x18’ (feet). We will provide CAD layout showing entire area including refrigerator and computer areas.

4.5.3. Vendor to provide input/output station for sorting specimen tubes into appropriate racks based on the tests to be done and archives specimens. System must be able to retrieve specimens from the storage module. Refrigerated Storage system is optional and cost-depending. Storage capability for minimum of 1000 specimens shall be included for online storage. Automated delivery and organization of specimens to outlet station based on bar-coded information. Storage and retrieval modules will handle waste disposal. Should have archive capabilities to locate samples.

4.5.4. Vendor is to provide a Hematology output buffer or add the hematology analyzer to the automation line.

4.5.5. Samples loaded onto the automation line must not require any sorting.

4.5.6. Hemoglobin A1C must be able to be loaded on the automation line without pouring off or pretreatment.

4.5.7. Minimum of 2 self-balancing centrifuges with adjustable spin time and RPM settings.

With the option to bypass the centrifuge without manual intervention, which is important for pre-spun samples.

4.5.8. Automated placement of specimens into and removal from centrifuges with minimum loading and unloading times for maximum productivity.

4.5.9. Charlie Norwood Veterans Hospital requires optimized automated delivery of specimens to Chemistry and Immunochemistry analyzers for parallel processing to provide best turnaround times and meet specimen handling requirements.

4.5.10. Automated system must priority STAT delivery and must be able to bypass routine while specimen traveling on the Automated track.

4.5.11. Uncapping and recapping system in an enclosed environment to prevent distribution of biohazardous aerosols and prevent evaporation.

4.5.12. Vendor to provide a universal carrier for automation lines allowing for multiple tube types and a reduction in racks for the automation line.

4.5.13. Vendor should provide the average number of service calls per year for the automation line.

4.5.14. Vendor to provide all utility requirements to operate all equipment.

4.5.15. Please provide 2 VA hospital references (location and phone number) with same track configuration being proposed for us.

4.6. Middleware-Integrated Data Management for Charlie Norwood Veterans’

Hospital:

4.6.1. The vendor must supply an open middleware solution. The system shall have the ability to interface to the current VA Hospital Information System (VISTA). The middleware will be sample workload management that includes routing, sample prioritization, sorting and archiving based on user defined parameters.

4.6.2. The technology interfaces with VISTA computer system through Data Innovations without an install cost generated by the VA.

4.6.3. The instrument’s computer must read code 128 label.

4.6.4. The system must have the capacity to connect to the current VA LIS system

(VISTA/Oracle Health) through Data Innovations and include a bi-directional LIS host query interfacing for both.

4.6.5. Capability of programming CAP specimens to allow interfacing with the CAP website.

4.6.6. Vendor supplies responses to required documents to add systems to the VA network including but not limited to the Enterprise Risk Analysis (ERA) VA Form 6550, Access

Control List (ACL) Communication Protocol, and MSD2

4.6.7. If the SQL server is included on the computer, it must be the newest vendor allows.

4.6.8. The instrumentation is 508 compliant.

4.6.9. VA form 6500, 6550, Risk Analysis, and MSD2 must be completed and signed by all parties before the contract can be awarded.

4.6.10. The hardware must meet all VA minimum specifications, and the operating system software version must be currently sold and supported. Windows versions no longer supported (e.g. Windows 10) shall not be proposed.

4.6.11. The vendor must supply necessary servers for a live environment, test environment and hot back up.

4.6.12. Vendor must supply one all-in-one-color printer and printer connection for the middleware solution.

4.6.13. Vendor must supply moving average module in the middleware for chemistry. The vendor must set up and configure the moving averages for the Charlie Norwood Veterans’

Hospital.

4.6.14. The vendor must provide a full and comprehensive rule writing service that facilitates the creation of auto verification. The rules for service shall include reference ranges, critical/rerun creation of auto verification. The rules service shall include reference ranges, critical/rerun ranges, delta checks, reruns, reflex testing, serum indices, QC, instrument exceptions and flags, hold for review, basic and complex calculations. The vendor must write the following specific rules.

(1) HIV rerun and duplicate interpretive rules

(2) Hepatitis reruns and duplicates interpretive rules.

(3) Complex Calculations (Free Testosterone).

(4) Moving averages configuration.

(5) Batch release in Vista.

(6) Lab Intelligence

4.6.15. Ability to manage rules for optimal specimen handling with ability to send automated comments based on the rules to patient host record. Linearity limits, repeats for critical value tests, review for specimen integrity and delta checks on previous patient results are examples of automatic rules functions required.

4.6.16. 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

4.6.17. HL7 instrument interface to send comments to host.

4.6.18. Bidirectional Interface shall be able to interface and automate the chemistry.

Immunochemistry instruments with orders and results separated for optimal transmission capable of automatically uploading test results.

4.6.19. Can Corrective Action be documented in middleware and stored for at least 2 years to satisfy CAP requirements?

4.6.20. Can Levy-Jennings charts be viewed in middleware to prevent having to review QC in each analyzer? Can the Levy Jennings charts be stored for 2 years to satisfy CAP requirements?

4.6.21. Connectivity for troubleshooting access from the manufacturer to the instruments and to the interface manager. Contractor will have knowledge of information Security requirements specific to VA installations and will work with government IT personnel to meet these requirements. Vendors may need to provide servers to accommodate production and test environment.

4.6.22. Prefer middleware to have ability to operate during VISTA downtime to provide a barcode/tracking system for samples coming in with no accession numbers. Can system merge the patient results in middleware to a newly assigned accession number when the

Vista LIS system is operational and results need to be entered?

4.6.23. Vendor must supply a mobile (mounted on wheels) command center monitor at least 42” screen which will allow the technologists to monitor the instruments (split screen) connections

4.6.24. Minimum of 6 thin clients or instrument screen.

4.6.25. Minimum of 6 thin clients with computers and 6 thin client middleware licenses for

Charlie Norwood Veterans hospital

4.6.26. System must have bidirectional interface from instruments to Data Innovations Interface manager to Hospital information System

4.6.27. Data Management with record storage including instrument of record for all patient results

5. Additional Chemistry System requirements:

5.3. Automated HIV assay with a minimal turnaround time to provide prompt reporting of

HIV testing to providers.

5.4. High Sensitivity STAT Troponin assay

5.5. Procalcitonin Assay use with automation (NO third-party assay)

5.6. Tacrolimus may require pretreatment but must not be a third-party assay.

5.7. Enzyme assays should use technology which has the capability to extend linear and reduce dilutions and reruns.

5.8. Hemoglobin A1C assay must require no pretreatment or pour off.

5.9. Hemoglobin A1C samples must be acceptable to load on automation without auto rocker

5.10. Vendor to provide ISE technology.

5.11. Both chemistry and immunoassay instruments must perform accurate automatic dilutions of range results.

5.12. The systems must be able to assess the level of common interferents (hemoglobin, lipemia, and icterus. For each sample without significantly decreasing overall sample throughput. List a sample volume requirement and time to result.

5.13. The vendor shall provide/install any routine and special items required to operate maintain the equipment/analyzer in optimal condition such as but not limited to linearity standards, printers, printer cartridges, water supply, drainage systems, consumable equipment parts, required replacement parts for maintenance or service etc. 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.

5.14. Vendor to provide an excel spreadsheet delineating the following parameters for each assay; calibration frequency, type of calibration, linearity, sample type, time to result, reagent and calibration, reagent and calibration storage requirements and number of tests per kit.

5.15. 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 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. In the event 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.

5.16. 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 operatory of QC failures and document out of range QC.

5.17. Upgraded Software/Equipment: The contractor shall not provide a bridged solution while awaiting FDA approval to upgrades the equipment hardware and operating system software. All instrumentation and reagents requested shall be FDA approved at the time of award.

5.18. Remote Instrument Monitor: Contactor shall provide remote access method to meet HIPAA and VA confidentiality requirements for customer support staff and remote diagnostic services.

5.18.1. The vendor must have/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 records must provide satisfactory documentation of receiving HIPAA training and complying with all HIPAA and patient confidentiality requirements.

5.18.2. An approved remote network communication system must be provided that continuously collects and monitors performance data of the analytical systems following all policies and procedures outlined in VA Directive 6500, Information Security Program, and its handbooks to ensure appropriate security controls are in place.

5.19. New Test Methods: Vendor/technical support specialist shall perform all validation studies including installation/set-up, correlation studies

(evaluation/comparison data sufficient to satisfy CAP/CLSI standards) and normal range studies at no initial charge.

6. Maintenance and Service Support Requirements:

6.1. Minimal Hands-on System Maintenance required, including limited reagent preparation time/steps prior to use. List reagent/calibration prep for assays. List out consumables.

6.2. Computer Patient Data Handling: No hardware containing any VA patient information is to be removed from any location, without the approval and removal of data by the VA information technology department. Failure to comply with this VA requirement may result in prosecution.

6.3. Preventive 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. Minimum of 3 per year per instrument unless documentation for volume performed denoted not required for optimum quality of operation.

6.4. Emergency Repair: Emergency repairs shall be performed after notification that the equipment in inoperative. The contractor shall provide the government with a designated point of contact and shall make arrangement to enable its maintenance representative to receive such notification. The contactor shall perform emergency repair service within 24 hours of time of notification of the malfunction.

6.5. Maintenance Support: Service repair person locally based within Charlie Norwood

Veterans’ Hospital geographical area.

6.6. Operator Procedure Manual: Operator and Service manuals along with CLSI compliant procedures must be furnished for each instrument model supplied, unless provided electronically on board the instrument. Vendor to write Standard Operating Procedures for each assay in the JAVAH template, to ensure that procedures are totally available prior to implementation.

7. Training and Technical Services Training:

7.1. The contractor shall include off-site (manufacturer facility) training for two operating personnel for each instrument installed and all automation system components at the time of installation of the contractor’s equipment and each year thereafter that the contract remains in effect. User training is to include all costs of off-site training, i.e., transportation (air and ground), room and board. In addition, 2 training slots per year will be provided each year of the contract.

7.2. On-site training by vendor shall also be supplied to all laboratory staff as needed.

7.3. 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.

7.4. 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.

7.5. The contractor, at his/her discretion, may make additional training available to his/her facility on terms and conditions mutually agreed upon by the agency and the contractor.

8. Installation and Initial Set Up:

8.1. 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.

8.2. SPACE REQUIREMENTS, SYSTEM SPECIFICATIONS, ETC.: Configuration of the proposed equipment must be able to conform to the space previously allotted for this function. System specifications must all be disclosed in the proposed space. Crossover from current to the new instrumentation must be performed timely with no interruption in patient care laboratory service. Installation must not require extensive renovations to allocated space at CNVAMC.

8.3. OWNERSHIP OF EQUIPMENT: Ownership of 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 orders, at termination and/or replacement of equipment, shall remove the equipment. The contractor shall disconnect the analyzer(gas, water, air, etc.) and shall be responsible for decontamination of the system, packing, and shipping required to remove the analyzer within (10) calendar days.

8.4. STANDARD AND ACCEPTANCE OF PERFORMANCE: This paragraph

establishes a standard of performance that must be met before and equipment listed on the deliver order is accepted by the government. This also includes replacement, substitute machines and/or machines that are added or field modified after a system has completed a successful performance period.

8.4.1. The performance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the contractor’s technical specification or as quoted in any contract at an effectiveness level of 99% or more.

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.

8.4.2. During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work will 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.

8.4.3. The government will maintain appropriate 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 performance period. Operations use time and downtime shall be measured in hours and whole minutes.

8.5. GOVERNMENT’s RESPONSIBILITY: The user will perform routine maintenance and cleaning as required in the manufacturer’s operation and maintenance instructions.

The user will maintain appropriate daily records to satisfy the requirements of this paragraph.

8.6. INSTALLATION PROCEDURES:

8.6.1. 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’s biomedical engineer. 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 complete.

In the event that progress of the installation is interrupted through no fault of the contractor, the continuous installation referenced in the proceeding paragraphs may be terminated until such time as the cause of the delay has been eliminated, and then shall be resumed within 24 hours after the contractor has been notified that work may again proceed.

8.6.2. Upon completion of installation the equipment shall be turned over to the hospital for use. Final acceptance of the equipment and installation will be based upon an inspection and test to be performed within ten (10) calendar days from the date of installation. If equipment passes inspection or if acceptance inspection is not conducted within ten (10) calendar days from installation, the government will accept installation with guarantee date commencing ten (10) calendar days after installation.

8.6.3. Vendor shall provide equipment installation and possible reinstallation at no cost if equipment is required to be moved due to construction or laboratory redesign.

9. SPECIFICS CONTRACT CRITERIA

9.1. Test menu: The Vendor must meet the test needs of the lab in its entirety. If a test is missing, the vendor must provide an acceptable substitute included in the contract.

Failure to provide a high priority test will eliminate the vendor from consideration. (see attachment A: Test Menu)

9.2. Structure: The Vendor will provide mirrored systems to be run in parallel. All tests do not have to be run on each system however STAT tests such as BMP, Cardiac testing, and high-volume therapeutic drugs must be run on both systems.

9.3. Automated workflow- the Vendor must provide an automated workflow system capable of processing spun and unspun blood. The system must be able to store and retrieve samples for add-on and repeat testing without the technician physically touching the tube.

10. Special Requirements for Awarded Contractor:

10.1. Vendor must meet, or improve each of the laboratory’s existing turn-around times as a minimum, by any change in instrumentation. Proposal should include automated pre-analytical specimen processing for Charlie Norwood Veterans’ Hospital. Method

Performance/Comparison shall be at the expense of the vendor and shall include linearity material and reagents and also be consistent with current CLSI Standards and related documents, CAP Standards and Federal Regulations for the following:

10.1.1. 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, and meet current standards defined by CLSI.

10.1.2. Linearity studies shall be performed on new contracted instruments for each analyte to determine reportable range with data reduction in accordance with CLSI guidelines.

10.1.3. Precision study 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 and a day-to-day precision study of normal and abnormal controls.

10.1.4. Sensitivity: Sensitivity may be validated concurrently with the linearity verifications.

10.1.5. Specificity studies: Adverse effects for increased bilirubin, hemolysis, lipemia, or other interfering substances including blood and urine container are evaluated for interfering substances for each method performed.

10.2. 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 for each lab. One of the following protocols should be used:

10.2.1. A verification of the manufacturer’s suggested reference range may be performed as long as the suggested range is based on a comparable population of test subjects.

The manufacturer must provide specific information defining how the suggested range was determined. A minimum of 30 female and 30 male reference individuals must be used to verify the manufacturer’s range. Any apparent outliers should be discarded, and new specimens obtained to provide a statistically valid verification.

10.2.2. If the suggested manufacturer’ range is not appropriate for the patient population, a reference range must be established and may require additional reference individuals.

10.2.3. If a laboratory is currently using the proposed instruments/reagent system, the “in-use” reference range can be transferred to the “new” system if a method comparison study between the two systems proves to be acceptable. If comparison studies are not acceptable, then an alternative test must be provided.

10.3. Therapeutic range validation studies must be performed by vendor for applicable analytics.

10.4. All technical procedures must be provided electronically by vendor in CLSI format, using software compatible with the laboratory’s computer system, for local modification (editable) to meet CAP requirements.

10.5. Carryover studies must be performed, as applicable, as part of the initial evaluation of the instrument. Vendor shall provide interpretation of raw data for each instrument installed and validate no carryover exists within the test platforms.

10.6. 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 (ie, vendor is to provide all manpower and reagents/supplies to do correlation studies).

11. Invoicing

11.1. Invoices shall be submitted electronically in arrears and in accordance with FAR clause 52.212-4 (g) and 52.323-34. Please reference the Purchase Order

11.2. Payment will be made upon receipt of a properly prepared, itemized invoice, validated by the COR, and submitted electronically.

11.3. A properly prepared invoice will contain:

11.3.1. Invoice Number and Date

11.3.2. Contractor’s Name and Address

11.3.3. Accurate Purchase Order Number

11.3.4. Dates delivery

11.3.5. Location of delivery

11.3.6. Total amount due

12. Quality Assurance Surveillance Plan (QASP)

REQUIRED SERVICE

PERFORMAN

CE

STANDARD

MONITORING

METHOD

RESULTS FOR

MEETING OR NOT

MEETING

THE

PERFORMANCE

STANDARDS

1. Contractor shall provide all technical support for installation of analyzers to bring the system to a fully operational status.

Ensure proper installation and operation.

Section 8 of the

SOW

Office Chief and/or Contract

Officers Representative

(COR) observation.

If contractor not able to meet all requirements this will result in an

Unsatisfactory

Performance Rating.

2. A continuous high level of quality testing and service will be assessed by the number of product recalls, discontinued tests, and number of instrument breakdowns.

Quality Service performance standard. Section

8.4 of the SOW

Inspection/ Observation

Customer complaints investigated and documented; contractor advised of results. 100% compliance required.

If contractor not able to meet all requirements this will result in an

Unsatisfactory

Performance Rating

3. Service calls, repairs, and preventative maintenance procedures completed with minimal interruption to ability of patient testing. Service report furnished upon completion of repairs.

Quality

Maintenance performance standard. Section

6 of the SOW

Inspection/ Observation

Customer complaints investigated and documented; contractor advised of results. 100% compliance required.

If contractor not able to meet all requirements this will result in an

Unsatisfactory

Performance Rating

REQUIRED SERVICE

PERFORMAN

CE

STANDARD

MONITORING

METHOD

RESULTS FOR

MEETING OR NOT

MEETING

THE

PERFORMANCE

STANDARDS

4. Monthly invoices (with supporting documentation) submitted in accordance with contract terms.

Quality

Timeliness performance standard.

Invoices submitted within

60 days of service. Section

11 of the SOW.

Audit of invoices and supporting documentation.

100% compliance required. If contractor not able to meet all requirements this will result in an

Unsatisfactory

Performance Rating

13. INCENTIVES AND DISINCENTIVES

There are no incentives or disincentives. The Government shall use the scoring methods above for continuing contract performance.

14. METHODS OF QUALITY ASSURANCE SURVEILLANCE

14.1. Various methods exist to monitor performance. The COR may use any surveillance methods listed below in the administration of this QASP.

14.1.1. DIRECT OBSERVATION: The COR can perform periodically or through

100% surveillance.

14.1.2. PERIODIC INSPECTION. The COR evaluates outcomes on a periodic basis.

Inspections may be scheduled daily, weekly, monthly, quarterly, or annually or use unscheduled inspections.

14.1.3. USER SURVEY: This method combines elements of validated user complaints and random sampling. Random survey is conducted to solicit user satisfaction. The COR may also generate inspections and sampling.

14.1.4. VALIDATED USER/CUSTOMER COMPLAINTS. This method relies on the patient to identify deficiencies. Complaints are then investigated and validated.

14.1.5. 100% INSPECTION. The COR may evaluate all outcomes.

14.1.6. RANDOM SAMPLING. This is designed to evaluate performance by randomly selecting and inspecting a sample of cases.

14.1.7. Progress reports or status meetings. The COR will analyze contractor's progress reports. (Evaluate cost, schedule, etc.)

15. RATINGS

15.1. Metrics and methods are designed to determine if performance exceeds, meets, or does not meet a given standard and acceptable quality level. A rating scale shall be used to determine a positive, neutral or negative outcome. The following ratings shall be used: 100% is positive, 95% is neutral, and 90% is negative.

16. DOCUMENTING PERFORMANCE

16.1. ACCEPTABLE PERFORMANCE (100% RATING)

The Government shall document positive performance. Any report may become a part of the supporting documentation for any contractual action.

16.2. UNACCEPTABLE PERFORMANCE (90% RATING)

16.2.1. When unacceptable performance occurs, the COR shall inform the contractor.

This will normally be in writing unless circumstances necessitate verbal communication. In any case the COR shall document the discussion and place it in the COR file.

16.2.2. When the COR determines formal written communication is required, the

COR shall prepare a Contract Discrepancy Report (CDR), and present it to the contractor and a copy to the Contracting Officer.

16.2.3. Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the Contracting Officer.