36C25919Q0191-005.docx

STATEMENT OF WORK

1. SCOPE:

VISN 19 Medical Centers and Community Outpatient Clinics (CBOCs) need a standard Hematology Analyzer(s) to conduct a variety of tests on a Cost-Per-Reportable-Result (CPRR) basis for our patient population. The Contractor shall provide analyzers and supplies to each facility in accordance with the Statement of Work (SOW). Participating VISN 19 Medical Centers and CBOCs are located as follows:

0. Grand Junction VAMC 2121 North Avenue Grand Junction, Colorado 81501

0. VA Montana Healthcare System 1892 Williams Street, off Hwy 12 West, Ft. Harrison (Helena), Montana 59636

0. VA Healthcare Center 1766 Majestic Lane, Billings, Montana 59102

0. VA SLC Health Care System 500 Foothill Drive, Salt Lake City, Utah 84148

1.5 Cheyenne VAMC 2360 E. Pershing Blvd Cheyenne, Wyoming 82001

1.9 Eastern Oklahoma VA Health Care System, 1011 Honor Heights Dr., Muskogee, OK 74401 (including Ernest Childers Outpatient Clinic, Tulsa, OK)

1. DEFINITION:

2.1 Cost-Per-Reportable-Result: The per reportable result price shall include costs covering (a) equipment use, (b) all reagents, calibrators, controls and their inter-laboratory QC comparison program, supplies, consumable/disposable items, parts, probes, needles, printers, Uninterrupted Power Supply (UPS), 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 shall also encompass all costs associated with dilution and 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, normal range, and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI). (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. (e) All packaging and shipping of reagents and supplies.

3. GENERAL REQUIREMENTS:

3.1 The Contractor(s) shall provide all supplies and services as described in the SOW.

3.2 Offered models of clinical laboratory hematology analyzers shall produce accurate and reproducible assays on biological and other specimens by established in vitro diagnostic methods. Model shall provide accurate test assay result for sample up to the manufacturer's defined maximum test per hour without excessive malfunctions, breakdowns, or service calls.

3.3 Offered equipment shall be new state-of-the-art equipment. All Contractors must submit an offer for new equipment, not previously used. Remanufactured and discontinued models will not be accepted. The models being offered must be in current production as of the date this offer is submitted.

3.4 The Contractor shall provide all upgrades to the equipment hardware and operating system software, at no additional cost to the Government. These enhancements shall be delivered and installed at each participating VISN 19 medical facility within 60 days of issuance to the commercial market.

3.5 Contractor offered equipment shall perform satisfactorily at any laboratory temperature between 50 and 90 degrees Fahrenheit and relative humidity between 15 and 85 percent.

3.6 Contractor’s offered hematology analyzer system shall conform to the VA facilities existing space. Equipment must be compatible to VA utilities systems of electricity, water, and power. A (UPS) uninterruptible power supply will be provided and maintained by contractor for each analyzer and equipment if required.

3.7 Contractor shall provide a printer for both primary and back-up analyzer and provide replacement printer as needed.

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 required to establish instruments for operation for performance of acceptance testing based on the test menu of each laboratory. This applies to all equipment including additional equipment added by modification and replacement equipment. The Contractor shall assist with the performance, to the satisfaction of the Government, all validation studies including: precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specificity at no cost to the Government. The Contractor shall perform all the statistical analysis described in the Method Performance/Validation section above and provide a hard-copy of the data in an organized, clearly comprehensible format. This applies to all equipment to include relocated, additional or replacement equipment.

3. All necessary maintenance to keep equipment in manufacturer's operating conditions, both preventive maintenance, and emergency repairs

4. Training for VISN 19 personnel operating equipment

5. The contractor is required to provide delivery, installation and removal of equipment at no additional charge.

SYSTEMS:

1. Contractor Data Management System- For the purposes of this requirement, this is a separate component or module that electronically connects the testing instrumentation to a data management system, results and workflow of typically 2 or more pieces of instrumentation. (Not to be confused with a computer that is required to operate the testing instrumentation or an instrument manager/middleware for interfacing equipment with the hospital information system. This may be proprietary to the equipment manufacturer or manufactured by a 3rd party. This will be included in the CPRR CBC pricing quoted).

a. Sufficient memory to store patient information and 50,000 test records with downloading capability to a 140-2 FIPS compliant external medium for long term storage of patient records and other information.

b. Patient status display for technologist review and workflow management for all integrated testing instrumentation.

c. Ability to retransmit patient records to universal interface system in case of interface outage.

d. Technology to automatically repeat testing based on customer configurable testing criteria (repeat testing).

e. Technology to automatically direct additional specimen testing based on customer-configurable testing criteria (reflex technology).

f. Contractor shall collaborate with each lab to write/develop protocols to establish customer configurable rules to enhance workflow management and productivity.

g. Contractor shall assist customer with optimizing operation and utilization of the data management system to fully integrate desired testing instrumentation enhancing productivity and management of workflow.

2.Automated Imaging System - Automated digital image analysis system, including an analyzer, personal computer and printer, which locates and pre-classifies white blood cells, pre-characterizes red blood cell morphology and performs platelet counts on peripheral blood smears and body fluids. Needed at these facilities: SLC, OKC, and Cheyenne (Cheyenne would like a quote without also).

a. The instrumentation must be approved by the Food and Drug Administration (FDA) and offered for laboratories. The system shall be networked to automated hematology instrumentation and shall have the following:

b. Bi-directional interfacing of results to VA VISTA laboratory information system.

c. Ergonomic workstation.

d. Ability to create digital slides of a defined area.

e. Ability to continuously load/feed slides.

f. Ability to remotely review images/slides without the use of a USB or toggle key.

g. Ability to retrieve previous patient slides/cells for comparison.

h. Ability to display cell image references on screen for immediate comparison.

i. Ability to add and store comments on any slide.

j. Complete traceability of results at the individual cell level. Automatic dispensing of immersion oil.

k. Ability to share a database when analyzers are on the same network. (Parent facility, outpatient clinic and/or CBOC lab)

l. Hard drive capable of storing up to 4,000 slides (approx. 20GB).

m. Ability to transfer slides to external storage media.

n. Performs automated microscopic differential on peripheral blood with the following:

o. Ability to perform a preliminary WBC differential by pre-classifying into their respective classes.

p. Ability to pre-characterize RBCs based on morphological characteristics.

q. Ability to provide a platelet estimate.

r. Ability to view all 100 cells on a single screen for confirmation of CBC analyzer result.

s. Ability to view cell classes side by side or full screen mode.

t. Ability to edit cell classifications when necessary.

u. Throughput up to 30 slides/hour.

v. Ability to view CBC results and flags while reviewing images.

w. Ability to provide access to scatterplots and histograms from CBC analyzer.

x. Overview of entire sample area in both 10X and 50 X magnifications.

3.8 Primary Processing Automation Line Instrumentation/Track system. Offering for an Integrated Clinical Laboratory Hematology Instrumentation and Robotics System (Automated track or line) the functionality in accordance with the requirements of each respective laboratory, as designated, shall have the following:

a. Sufficient capacity and throughput to meet the volume and service demands.

b. Includes a specimen management system to manage and track sample progress and position.

c. Specimen archival through mapping of specimens to racks; for easy retrieval once moved off-line. (Specimen Management System).

d. The ability, based on test requests, to sort specimens. (Line/track system/ Specimen Management System)

e. The ability to send processed specimens by means of a tracking system to the proper testing instrumentation to maximize efficiency and to maintain and standardize turnaround times of results. (Line/track system/ Specimen Management System)

f. The ability to detect processing errors and provide error notification. (Specimen Management System)

g. The ability to isolate primary analyzers from the processing equipment when necessary. (Specimen Management System)

h. The ability to connect by a line or track system all primary and back-up testing analyzers offered. (Line/Track System).

i. The ability to maintain, sort and store specimens. (Storage or Stockyard)

j. The system must contain computer interface compatible with the current VA laboratory information system and existing universal interface. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system.

k. Barcoding stations located at key points along the line or track system must have the following capabilities:

l. The accuracy of the barcode reading must have less than a 0.5 % failure rate.

m. Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently.

n. Equipment must accept, at a minimum, 10 characters in specimen identifier that is alpha, numeric, and/or alphanumeric concurrently.

SOFTWARE:

Operational Features- Operating system software shall be currently sold and supported. Instrumentation and devices with operating systems such as Windows XP that are no longer supported by the manufacturer shall not be offered.

Ancillary support equipment - The Contractor shall provide, install and maintain any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. carts for non-floor standing instrumentation, cabinetry to support/house the analyzer (if necessary), water systems (including consumable polishers, filters, etc.), and universal interface equipment, etc. In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, tables/stands, etc.

a. The Contractor shall provide any and all necessary software support for insuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself.

b. Information necessary to make the determination for type and amount of interfacing equipment is supplied.

c. If a site already has a universal interface box, the Contractor is responsible for everything leading up to the box including any incremental fee required to add additional equipment (e.g. licenses, ports/cards, cables, software, etc.) to the universal interfacing system.

d. If a site does not have a universal interface instrument manager for the testing instrumentation quoted and one is needed to optimally interface the instrument, then the Contractor is responsible for the acquisition of the universal interface manager, license(s) and everything else needed to connect with VA computerized hospital information system.

e. If there are any software upgrades in the instrument during its lifetime, the Contractor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VA computerized hospital information system.

f. The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and assists in regulatory compliance.

g. Computer disc containing their procedure manual in CLSI format or an on-line procedure manual in the instrument software.

3.9 Equipment must meet the volume and turnaround time requirements, if specified, of the using facilities. See the Facilities’ Specific Requirements.

3.10 Assays: Contractor’s hematology system shall be capable of performing the following Hematology Assays:

1. White Blood Cell count, (Cheyenne, Loveland, Sheridan, OKC/LAW, Fort Harrison, Grand Junction, Billings, Muskogee, SLC)

1. Red Blood Cell count, (Cheyenne, Loveland, Sheridan, OKC/LAW, Fort Harrison, Grand Junction, Billings, Muskogee, SLC)

1. Hemoglobin, (Cheyenne, Loveland, Sheridan, OKC/LAW, Fort Harrison, Grand Junction, Billings, Muskogee, SLC)

1. Hematocrit, (Cheyenne, Loveland, Sheridan, OKC/LAW, Fort Harrison, Grand Junction, Billings, Muskogee, SLC)

1. Indices= MCV, MCH, MCHC, (Cheyenne, Loveland, Sheridan, OKC/LAW, Fort Harrison, Grand Junction, Billings, Muskogee, SLC)

1. Platelet count, (Cheyenne, Loveland, Sheridan, OKC/LAW, Fort Harrison, Grand Junction, Billings, Muskogee, SLC)

1. Immature Platelet Fraction (Cheyenne, Loveland, Sheridan, Fort Harrison, Grand Junction, Billings, SLC) Not needed at Muskogee, OKC/LAW

1. Neutrophil percentage, (Cheyenne, Loveland, Sheridan, OKC/LAW, Fort Harrison, Grand Junction, Billings, Muskogee, SLC)

1. Lymphocyte percentage, (Cheyenne, Loveland, Sheridan, OKC/LAW, Fort Harrison, Grand Junction, Billings, Muskogee, SLC)

1. Monocyte percentage, (Cheyenne, Loveland, Sheridan, OKC/LAW, Fort Harrison, Grand Junction, Billings, Muskogee, SLC)

1. Eosinophil percentage, (Cheyenne, Loveland, Sheridan, OKC/LAW, Fort Harrison, Grand Junction, Billings, Muskogee, SLC)

1. Basophil percentage, (Cheyenne, Loveland, Sheridan, OKC/LAW, Fort Harrison, Grand Junction, Billings, Muskogee, SLC)

1. Neutrophil Absolute value, (Cheyenne, Loveland, Sheridan OKC/LAW, Fort Harrison, Grand Junction, Billings, Muskogee, SLC)

1. Lymphocyte Absolute Value, (Cheyenne, Loveland, Sheridan, OKC/LAW, Fort Harrison, Grand Junction, Billings, Muskogee, SLC)

1. Monocyte Absolute Value, (Cheyenne, Loveland, Sheridan, OKC/LAW, Fort Harrison, Grand Junction, Billings, Muskogee, SLC)

1. Eosinophil Absolute Value, (Cheyenne, Loveland, Sheridan, OKC/LAW, Fort Harrison, Grand Junction, Billings, Muskogee, SLC)

1. Basophil Absolute Value, (Cheyenne, Loveland, Sheridan, OKC/LAW, Fort Harrison, Grand Junction, Billings, Muskogee, SLC)

1. Red Cell Distribution Width-SD, (Cheyenne, Loveland, Sheridan, OKC/LAW, Fort Harrison, Grand Junction, Billings, Muskogee, SLC)

1. Red Cell Distribution Width-CV, (Cheyenne, Loveland, Sheridan, OKC/LAW, Fort Harrison, Grand Junction, Billings, Muskogee, SLC)

1. Mean Platelet Volume, (Cheyenne, Loveland, Sheridan, OKC/LAW, Fort Harrison, Grand Junction, Billings, Muskogee, SLC)

1. Reticulocyte percentage, (Cheyenne, Loveland, Sheridan, OKC/LAW, Fort Harrison, Grand Junction, Muskogee, SLC)

1. Reticulocyte Absolute Value, (Cheyenne, Loveland, Sheridan, OKC/LAW, Fort Harrison, Grand Junction, Muskogee, SLC)

1. Retic Hemoglobin (Cheyenne, Loveland, Fort Harrison, Sheridan, Grand Junction, SLC)

1. Immature Reticulocyte Fraction (Cheyenne, Loveland, Fort Harrison, Sheridan, Grand Junction, SLC) Not needed at Muskogee or OKC/LAW

1. Immature Granulocyte absolute value, (Cheyenne, Loveland, Sheridan, Fort Harrison, Grand Junction, Billings, SLC) Not needed at OKC/Lawton, Muskogee

1. Immature Granulocyte percentage. (Cheyenne, Loveland, Sheridan, Fort Harrison, Grand Junction, Billings, SLC). Not needed at OKC/Lawton, Muskogee

1. Automated Cell Count on various body fluids, including but not limited to Cerebral Spinal, Pleural, Peritoneal and Synovial Fluids, shall include WBC, RBC and Total Nucleated Cell (TNC) counts. (Cheyenne, Fort Harrison, SLC needs body fluid and CSF) Not required for Billings, Loveland, Sheridan, Muskogee, OKC, Grand Junction

3.11 Equipment Configuration: Contractor owned hematology systems must meet the following global criteria for all VISN 19 Lab Services:

1. Auto-sampler Fully automated sample processor that is part of the testing instrumentation. The processor accepts multiple samples for continual uninterrupted testing to allow for “walk-away” sampling and testing.

1. Primary tube cap piercing sampling

1. Open and closed mode sampling

1. Bar-code capability for samples, reagents and controls.

1. Bi-directional interface for Data Innovations and Cerner with VISTA.

1. Ability to recall and re-transmit test results to host computer

1. Easily accommodate STAT tests.

1. Ability to analyze small volume samples.

1. On-board Reagent Inventory including an alert when consumables and supplies are insufficient to process requested tests.

1. On-board user-friendly Quality Assurance program.

1. Long shelf life for reagents and controls, including on-board stability.

1. Minimal, user-friendly maintenance procedures.

1. Assay procedures in CLSI (Clinical Laboratory Standards Institute) formerly NCCLS format and on diskette or on Internet (secured).

1. Operators Manual also on disc or print.

1. Software is upgradeable (provide list of versions).

1. Software upgrades automatic at no cost to user, and include training if needed.

1. UPS provided by contractor, and maintained.

1. Minimal interference from lipemia, icterus, and cold agglutinins.

1. Modem or Remote access for aid in troubleshooting.

1. Upon completion of installation at each participating VISN 19 Medical Center, the contractor shall perform all validation procedures including linearity, precision, correlation, and reference range studies at contractor’s expense.

1. All analyzers must use the same reagents, calibrators, and controls for primary and back-up analyzers.

1. All back-up analyzers must provide the same reference ranges as the primary analyzer.

4. MANDATORY REQUIREMENTS:

4.1 The vendor will provide each participating facility with Food and Drug Administration (FDA) approved analyzer/equipment, reagents, controls (both whole blood and body fluid), calibrators, disposables, any consumable part (inclusive of replacement parts per manufacturers maintenance guidelines, cap piercing needles, specimen racks, sample holders, etc.), necessary for analyzing/testing on both the primary and back up analyzers. All linearity material and any commercial system correlation samples needed shall be provided to meet College of American Pathologists (CAP) and the Joint Commission requirements.

4.2 Contractor shall specify calibration frequency and if calibration is performed by the user or the vendor’s Field Service Representative.

4.3 Contractor shall provide three levels of whole blood commercial quality controls to be analyzed on each primary and back-up analyzer for every eight hours of operational shift or per the requirement of each facility/clinic. Contractor shall provide two levels of commercial body fluid quality control to be analyzed as needed by operational shifts if warranted. Contractor shall state control stability and expected frequency of adjustments of ranges within lot numbers (to include both whole blood and body fluids).

4.4 The Contractor shall provide manufacturer verified documentation of sample stability for specimens up to 48 hours after collection.

4.5 The system shall have the capability to set-up decision rules/flagging criteria for specimens requiring manual review. The decision rules/flagging criteria may also be applicable to slide maker/stainer and may be user defined.

4.6 The Contractor is to define the actual hands on maintenance time required for daily, weekly, monthly, and as needed maintenance. The vendor is to include the analyzer time required to perform each maintenance task. Vendor shall list which tasks are user level and which tasks are service level.

4.7 The vendor must provide a comprehensive Quality Control (QC) program included in the CPRR price, which includes the following options:

a. QC files that can be edited or corrected for errors

b. Have on-board quality control data storage and reporting capabilities

c. Ability to view/print daily, monthly QC results and Levy-Jennings graphs

d. Ability to visually alert operator of QC failures.

e. Quality Assurance program that has peer participation of at least 50 participants. Peer data reports available online.

4.8 A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system.

4.9 The accuracy of the barcode reading must have less than a 0.5% failure rate.

4.10 Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently.

4.11 Equipment must accept, at a minimum, characters in specimen identifier that is alpha and/or numeric depending on site that may be enabled concurrently.

4.12 The ability to continuously load patient specimens.

4.13 The ability to support walk-away testing and detect and alert operator of short samples and/or insufficient reagent volume.

4.14 Minimal daily, monthly, and periodic maintenance.

4.15 Ability to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage.

4.16 Bar coding of reagents to include product, lot number and expiration date.

4.17 On board reagent inventory management to include tracking of “on-board” stability of reagents.

4.18 On board reagent stability, sufficient to accommodate both high and low volume use. Contractor to provide expiration dates of at least three (3) months for reagents.

4.19 Capability to detect and alert operator of out of range quality control results via flagged results on QC printout and visual alerts on display monitor.

Technical Features- The testing instrumentation must be approved by the Food and Drug Administration (FDA).

Upgrades - The Contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and the state-of-the-art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to “system upgrades” that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided; however, it does refer to significant changes in the hardware operational capability. In addition, it does not negate upgrade to replace existing equipment when proposed equipment fails to meet lab testing demand.

Interface Requirements- The Contractor shall be responsible for providing all hardware required for the connection, implementation, and operation of the interface to the universal interface and any incremental fee that is required each time an instrument is added to an existing universal interface system. Note: Laboratory Instrumentation uses network wiring to connect to the universal interface (Data Innovations of Dawning). The universal interface is on the medical VLAN and uses the network wiring to connect to the network. No patient data leaves the VA.

5. TRANSITION:

5.1 The Contractor shall remove all equipment within 90 days of the expiration of the term of the contract but not until the completion of the new Contractor’s equipment installation inclusive of completed cross over studies. Each facility, per their protocol, will be responsible for the removal/erasing of the hard drive at analyzer removal/upgrade.

Transition from prior contractor:

(a) Upon award, the transition period for the awarded contractor to have all Hematology equipment and peripherals installed and operational at the effected facility shall be 30 calendar days after award. During this same period all initial training of VA personnel in the operation and maintenance of said equipment shall also be complete.

(b) Contractors shall provide with quotes a plan for transitioning services from the incumbent contractor to the new awarded contractor. Contractor's submitted transition plan shall not exceed 30 calendar days for installation and training of VA personnel. Failure of the contractor to conform to the transition period shall be considered as sufficient cause to terminate for cause. The VA shall have sole discretion in the decision to terminate for failure to comply.

(c) No later than 45 calendar days after award, the Contractor shall have completed full transition of all services under this agreement to include all correlation studies, validations, etc., and shall have full and sole responsibility for services.

5.2 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 manufacturers claimed specifications. The total equipment, per specifications, in each of the laboratories will not negatively impact the functionality and operations of the laboratory or pose a safety hazard. It shall not require infrastructure changes. The Contractor shall be responsible for visiting and assessing, along with representatives from Laboratory, Bio-Med, and Clinical Engineering, the space/utilities available in each laboratory in order to determine specific site prep requirements including but not limited to:

a. Space availability

b. Power availability, including special receptacle requirements

c. Other utility availability water, drains, etc., as required

d. Increase heat load affecting air conditioning

e. Specialized ventilation, if required

f. Special finishes required

g. Carts for non-floor standing instrumentation

5.3 Implementation/transition timeframe - The implementation of the services/requirements described in this SOW shall be completed no later than 90 days after award. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. Contractor shall not be penalized for implementation timelines that extend beyond the 90-day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government.

Upon award, the transition period to have all equipment and peripherals installed and operational shall be from date of award through days. During this same period, all initial training of VA personnel in the operation and maintenance of said award shall also be completed.

Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor’s submitted plan shall not exceed days for the transition of all services including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations. Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate.

At the end of days from award Contractor shall have full and sole responsibility for services.

6. ANALYZER

6.1 The capability of performing analysis on 100% of the tests.

6.2 Sufficient capacity and throughput to meet the volume and service demands based on each laboratory’s hours of operation.

6.3 Instrumentation proposed for a Medical Center and their associated outpatient clinic laboratories shall be FDA approved for reporting the same CBC and automated differential parameters.

6.4 A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory.

6.5 A separate monitor/screen for each analyzer, unless integrated into one system.

6.6 All monitors/screens will clearly display information in all light conditions.

6.7 A printer that has the capability of printing a patient report with patient demographic information that includes minimally the patient’s name and accession or unique identifier number (UID).

6.8 To assure proper instrument operation, the contractor shall supply an uninterruptible power supply (UPS) with each instrument/piece of equipment. Each UPS shall meet and support the specific electrical needs for the equipment to which it is connected within each laboratory, to include a built-in surge suppressor and line conditioner. This includes UPS units for automation lines, specimen management systems, slide maker, slide stainer and all other instrumentation provided. Each UPS must provide electrical power for a minimum of 15 minutes after electrical power fails and the system must allow for an automatic controlled shutdown to prevent damage to the instrument and data records.

6.9 For each analyzer that utilizes/requires high quality of water, i.e. reagent grade water, etc. for dilution of concentrated reagents, Contractor shall provide a water system capable of generating the required quality, pressure and volume of water to meet manufacturer’s specifications and sustain instrument operations to support maximum through put, as part of the all-inclusive CPRR pricing. This includes, but is not limited to, pre-filter, softeners, service and repairs, maintenance agreement, etc. and any items necessary for feed (i.e., source) water prior to processing by the water system. Needed for OKC.

6.10 An auto sampling system that includes cap piercing closed tube aspiration, auto-loader, and auto-mixing.

6.11 Primary tube sampling from various manufacturers and sizes of evacuated tubes.

6.12 Audible notification of sample aspiration error.

6.13 Ability to sample in both open and closed mode.

6.14 Manual sampling mode that reads barcode label.

6.15 Displays minimal background counts and technology based histogram “flags” minimized and flexible for user designated modifications (as reflected by percent manual differentials in user groups).

6.16 Contractor Quality Assurance Program to include peer group specific monthly QC analysis provided to each laboratory.

CHARACTERISTICS:

1. The analyzer includes an integrated slide maker/stainer (not needed in Loveland, Billings)

2. The vendor may provide innovative technology for slide review/interpretation that can be interfaced with the existing hardware. Automated manual Differential review digital cell morphology. not for Loveland).

3. The analyzer has the technology for IPF and RET-He. Not needed for Muskogee, OKC/Lawton

4. The analyzer has single aspiration pathway which negates mode-to-mode comparisons and separate QC files for manual mode analysis.

5. Calibrations performed by Field Service Representatives.

7. Consumables, Inventory Control Reagents, Supplies and Disposables:

The Contractor shall maintain on Government provided space a continuously stocked inventory of reagents, calibrators, controls, supplies, disposables and any other material required to properly perform tests on the offered equipment. The Contractor shall pay all routine shipping fees for supplies, consumables, and equipment to perform testing at initial installation and with routine supply delivery. These items shall be of the highest quality ensuring sensitivity, specificity and tested to assure precision and accuracy. The quality of the products shall be sufficient to satisfy proficiency testing standards of the College of American Pathologists (CAP) and the Joint Commission on Accreditation of Health Care Organizations. In the event the consumables are found to be defective and unsuitable for use with the contractor's equipment, or the contractor has failed to comply with the requirements for routine supply delivery, the contractor shall deliver the consumable supplies within a period of twenty-four (24) hours after receipt of the verbal order for priority delivery from the Government activity. If either circumstance has occurred, the contractor shall deliver to the requesting VISN 19 facility 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 will be honored by the contractor until the arrival at the Government site of the monthly standing order/routine supplies delivery. Failure to reserve adequate inventory may result in default.

8. WASTE/DECONTAMINATION

8.1 Safety features to avoid unnecessary exposure to biohazardous and chemical materials. The exposure to and the volume of biohazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling.

8.2 Mandatory inclusion of preventative maintenance and/or decontamination procedural guidelines for the disinfection of analyzers used in clinical laboratory testing of specimens suspected or confirmed to be infected with highly pathogenic organisms.

8.3 Characterization of waste – The Contractor shall provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges in accordance with the requirements of the Code of Federal Regulations Title 40 “Protection of the Environment” Part 261 et seq. and applicable state and local requirements. Documentation shall include a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations, Safety Data Sheets (SDS) meeting the requirements of the Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA), the analytical process used to determine the hazardous nature and characteristics of the waste, and the analytical test results. Testing of hazardous waste is to be done in accordance with testing protocol specified for each individual waste as described in the Code of Federal Regulations Title 40 to make a determination if the waste is a hazardous waste or otherwise regulated.

8.4 The determination and description shall address the following:

Waste toxicity (Reference 40 CFR §261.11 and 40 CFR §261.24) Waste ignitability (Reference 40 CFR §261.21) Waste corrosivity (Reference 40 CFR §261.22) Waste reactivity (Reference 40 CFR §261.23) Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR §261.31) Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40 CFR §261.33) Solid Waste (Reference 40 CFR §261.2) Exclusions (Reference 40 CFR §261.4)

8.5 The Contractor will provide written instructions and training material to ensure VHA laboratory staff are trained as needed to properly operate devices with special emphasis to managing and disposing of hazardous waste in accordance with EPA and state requirements. Additionally, the training provided by the contractor must fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices.

8.6 Contractor shall provide a description of all wastes the process or equipment may discharge so that the facility can determine whether the discharge meets Local Publicly Owned Treatment Works (POTW), State and Federal discharge requirements. At a minimum, the characteristics of ignitability, corrosivity, reactivity and toxicity as defined in 40 CFR §261 must be determined and documented. Any mercury containing reagents must be identified in any concentrations. All test results shall be provided. All listed chemicals (F, U, K and P) found in 40 CFR §261 shall be provided in product information and their concentrations documented. For those materials with a positive hazardous waste determination, a mechanism for the laboratory to meet local discharge requirements (i.e. mercury, thimerosol and formaldehyde) must be developed and SDS sheets must be provided in advance for review. At a minimum, documentation shall include, but not be limited to the concentration/measures of the elements and parameters listed below and must be included with vendor response:

5.20.5.6.3

pH

5.20.5.6.15 Flash point (to higher than 200°F)

BOD; biochemical oxygen demand

8.7 The documentation the contractor provides will be used to work with the VAMC and the public and/or private organization (e.g., POTW) to determine whether or not the waste from each device can legally be disposed of via the sewerage system

9. Method Performance/Validation Requirements

9.1 Method performance/comparison shall be at the expense of the Contractor, shall include linearity material and reagents, and be consistent with current CLSI guidelines and related documents, College of American Pathologists (CAP) standards and Federal regulations.

9.2 Correlation studies for each analyte/matrix as appropriate based on individual lab test menu. A minimum of 20 samples spanning the reportable range shall be run by the present and the proposed method. In systems where multiple sampling modes exist, mode to mode correlation studies must also be performed. Contractor shall analyze results and provide statistical data to support acceptance of the new method for above studies. Statistics shall consist of at least mean, bias, slope, y-intercept, correlation coefficient, ROC analysis, and meet current standards defined by CLSI. Additional requirements apply and are described at the end of this section, for the laboratories receiving automated digital imaging technology systems.

Analytical Measurement Range (AMR) Validation shall be performed on proposed instrument(s) for each parameter to validate the reportable range. The material must have values, which are near the low, mid, and high values of the AMR and be of appropriate matrix for the clinical specimens assayed by that method. A minimum 5-point linearity analysis that adheres to the Beer-Lambert Law and spans the entire range shall be performed as a minimum.

Precision study using normal and abnormal control material. This shall consist of a within run precision study of 10 normal and 10 abnormal controls and a day-to-day precision study of normal controls and abnormal controls for 10 days (may be run twice a day) for a total of 20 values per level of control. Intra-VISN facility variations should be kept to an absolute minimum.

Sensitivity. Sensitivity may be validated concurrently with correlation studies. Mathematical calculations to determine efficiency, sensitivity, false positive rate and false negative rate are applied.

Specificity Studies. A review of product literature and assay inserts to determine any adverse effects for increased bilirubin, hemolysis, lipemia, or other interrupting substances.

Carryover Studies. Successful carryover studies shall be completed by the contractor on all analyzers during installation. These studies shall be performed using either contractor developed program(s) or program(s) developed by a third party (CAP/CLSI). The programs shall be provided to each laboratory at no charge. This applies to the testing instrumentation and slide maker/stainers.

Verification of the effectiveness of manufacturer’s mixing method(s) to ensure all specimens are thoroughly mixed immediately prior to analysis. (Validation performed must be adequate to meet CAP Hematology checklist requirements, including the supporting documentation)

9.3 Validation/Evaluation of Digital Imaging Technology Systems

9.4 The evaluation of the digital imaging system will consist of comparing leukocyte differentials obtained by the reference method (technologists manually counted differentials utilizing light microscopy) with those obtained by the new method. A minimum of 200 samples should be used for peripheral blood. 20 samples should be adequate for other body fluids. The comparison will include accuracy, short-term precision and clinical sensitivity and specificity. Manufacturer’s recommended guidelines will be followed. A brief summary is described below.

9.5 Accuracy-the accuracy evaluation involves comparison of the results for each leukocyte class. The regression analysis shall be calculated with the mean value for respective sample and performed according to any statistical textbook.

9.6 Short-Term Imprecision-the short-term variation is the standard deviation, for each cell class, between slide A and slide B. See NCCLS H20A1

9.7 Clinical Sensitivity and Specificity- clinical sensitivity and specificity shall be calculated for distributional and morphological results separately. Refer to the Full Study document for peripheral blood.

The Contractor shall assist/perform all of the statistical analysis described in the Method Performance/Validation section above and provide a hard-copy of the data in an organized, clearly comprehensible format. Contractor Technical Specialist (or equivalent) will present and discuss all correlation and statistical analysis results with the Hematology Supervisor and designated staff at each participating lab.

9.8 Reference Range- A reference range must be determined for each test following CLSI guidelines. Samples used for the reference range study must be representative of the patient population being tested. Reference range assessment must be performed for each lab. One of the following protocols shall be used:

9.9 A verification of the manufacturer’s suggested reference range may be performed as long as the suggested range is based on a comparable population of test subjects. The manufacturer shall provide specific information defining how the suggested range was determined. A minimum of 20 reference individuals shall be used to verify the manufacturer’s range. Any apparent outliers should be discarded and new specimens obtained to provide a statistically valid verification.

9.10 If the suggested manufacturer’s range is not appropriate for the patient population, a reference range shall be established. Establishing a reference must follow CLSI guidelines. This requires a minimum of 120 reference individuals to be used to establish a reference range. The reference interval should be determined using the nonparametric method.

9.11 If a laboratory is currently using the proposed instrument/reagent system, the “in-use” reference range can be transferred to the “new” system if a method comparison study between the two systems proves to be acceptable. If comparison studies are not acceptable, one of the two above items must be performed.

10. Training.

10.1 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 service. This key operator training for 2 operators for each piece of equipment, shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide training for minimally one (1) operator per laboratory per year at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the Government and the Contractor. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant at the contractor’s expense.

In addition to the training above the following shall be provided:

10.2 Basic operator training for equipment shall be provided by Contractor on-site for all operators on all shifts, as applicable to each individual laboratory’s testing schedule and hours of operation.

10.3 Advanced training shall be provided on instrument troubleshooting, advanced middleware rules writing, data analytics, report writing and customization, on site or at contractor’s facility. Contractor shall provide an electronic version of each test procedure written in CLSI format or access to downloadable versions of test procedures (in WORD), which are easily editable/adaptable into local laboratory policy format. Procedures submitted in Adobe shall be converted by the Contractor for ease of use by the laboratory.

(a) With the exception of the specific training requirements stated herein, which shall have precedence; Contractor shall provide initial in-depth training for two key operators at each VA site and for each individual instrument provided, all expenses paid. Provide annual training for one VA equipment operator, per each instrument, for each participating VISN 19 medical center at contractor’s expense.

(b) Provide on-site Contractor operator training for all personnel who will run instrument with training provided for all applicable shifts.

11. Equipment Preventative Maintenance/Repair Service.

11.1 The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all primary and back-up instrumentation, processing automation line instrumentation (to include all components) and any incremental support equipment, e.g. water system, UPS Uninterruptible power supply, etc. offered according to the following terms:

A technical assistance center shall be available by telephone 24 hours per day, 7 days per week with a maximum call back response time of 1 hour (60minutes).

Equipment repair service shall be provided 24/7 for medical center based laboratories and 5 days per week during core business hours for outpatient clinic laboratories for Hematology instrumentation, automation systems, ancillary support equipment, etc. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours for outpatient clinic labs. Service coverage may differ for the Digital Imaging Systems. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel.

Equipment repair response time (on-site arrival) shall be no more than 24 hours. This applies to all labs regardless of the number of primary and back-up analyzers.

11.2 A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following:

1. Date and time notified

1. Date and time of arrival

1. Serial number, type and model number of equipment.

d. Time spent for repair, and proof of calibration or calibration verification following repair or replacement of major components/systems to ensure compliance with current CAP accreditation requirements and CLSI guidelines.

11.3 Proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

Each notification for an emergency repair service call shall be treated as a separate and new service call.

11.4 Preventative maintenance will be performed as frequently as published in manufacturer’s operator’s manual and within 2 weeks of the scheduled due date.

11.5 A service report shall be furnished to the Laboratory upon completion of each PM. The report shall include, as a minimum, the following:

Date and time notified Date and time of arrival Serial number, type and model number of equipment Time spent for repair, and Proof of calibration or calibration verification following service to ensure compliance with current CAP accreditation requirements and CLSI guidelines.

Proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

11.6 Maintenance and Repairs: