Attachment 1 Hematology - SOW 11 June 2024.pdf

STATEMENT OF WORK

FOR

David Grant Medical

Center

(DGMC)

Cost Per Reportable (CPR)

Automated Hematology System

Revised Date: 11 June 2024

TABLE OF CONTENTS

Section

1. Description of Services

2. General Information

3. Available Services

4. Technical Requirements

5. Definitions/Acronyms/Publications/HIPAA

6. Attachments/Technical Exhibit Listing

7. Hematology Analyzer System Installation

8. DHA Medical Device Equipment Cybersecurity/Risk Management Framework Requirements

PART 1

1.0 DESCRIPTION OF SERVICES

1.1. Description of Services: David Grant Medical Center requires a fully automated Hematology System that can perform all its necessary hematology testing assays. The Laboratory requires a solution for complete blood count (CBC) testing, body fluid testing, a slide maker/stainer, and a slide reader.

1.2 Scope: The Contractor shall provide all management, tools, parts, materials (including all reagents, quality control materials, and consumable parts and accessories), equipment, travel, and labor necessary to provide the instrumentation described in Part 4 for the Clinical Lab located at David Grant Medical Center, Travis AFB. In addition, the Contractor shall include all site preparation, extended installation, incidental services, labor, shipping, supplies, materials the Contractor will be responsible for to provide a fully operational turn-key system, meeting all minimum requirements and essential characteristics for each respective analyzer per the Statement of Work. Services include instrument use, preventive maintenance, troubleshooting guidance, 24/7 telephone service as well as response by a technical expert provided by the contractor 7 days per week from 0000 to 2359, including Federal Holidays and calibration services, not included in routine maintenance, at frequencies specified in the manufacturer’s service and operations manuals, and any required intervening repair service requirements for the entire contract period, including options if exercised. Expedited shipping options, to include overnight, should emergent supply needs arise. All patient and testing information must be accessible and accurate. All services provided shall be performed in accordance with all applicable laws, regulations, standards, local instructions, and commercial practices.

1.3 Objectives:

1.3.1 Must provide a fully automated hematology system, allowing for all Hematology testing to be performed using one single stand-alone system. System must include two cell counter analyzer modules, body fluid module, reticulocyte module, slide maker module, and slide reader/photo imaging module.

1.3.2 Must be capable of performing all required hematology testing assays outlined in Part 6 Attachment 2, encompassing both complete cell count and body fluid testing assays. All tests must be FDA approved.

1.3.3 Must have a current Authorization to Operate (ATO) or be in the process of acquiring ATO for networked information technology to receive, process, store, display, or transmit Defense Health Agency (DHA) information. All aspects of the contractor’s system, to include both the analyzer itself and any associated components, software, and hardware, must have a current ATO authorization or be in the process of acquiring ATO. The vendor is required to maintain ATO authorization for all aspects of the provided system for the entire duration of the contract.

1.3.4 Must be compatible with Military Health System and the Genesis Electronic Healthcare Record Platform.

1.3.5 Test performance and results will be 24/7 with no downtime.

1.3.6 All periodic preventive maintenance specified as not performed by end-user is upkept by the contractor and always performed within its recommended timeframe.

1.3.7 Performance of preventive maintenance, calibration, and quality will not render the department incapable of performing or resulting any testing.

1.3.8 Testing must be provided in a Cost Per Reportable (CPR) billing format.

1.4 Period of Performance (PoP):

Base Year: 1 Sep 24 - 31 Aug 25 OY1: 1 Sep 25 - 31 Aug 26 OY2: 1 Sep 26 - 31 Aug 27 OY3: 1 Sep 27 - 31 Aug 28 OY4: 1 Sep 28 - 31 Aug 29 6 Mo Ext: 1 Sep 29 – 28 Feb 30

PART 2

2.0 GENERAL INFORMATION

2.1 Contractor Identification

2.1.1 Contractor personnel performing services in a contractor capacity in a government facility are required to possess and wear an identification badge that displays his or her name and the name of their company.

2.1.2 Contractor personnel will be required to attend meetings or otherwise communicate with Government and/or other contract representatives to meet the requirements of this order. Contractor personnel shall make their contractor status known during introductions.

2.1.3 Contractor personnel, while performing in a contractor capacity, are prohibited from using their retired or reserve component military rank or title in any written or verbal communications associated with the contracts in which they provide services.

2.2 Place of Performance: The work shall be performed at David Grant Medical Center, Travis AFB.

2.3 Mission/Emergency Essential. The services outlined in this SOW are considered mission/ emergency essential. Inability to secure services on a timely manner can preclude use of medical equipment, cause compliance violations, and impair the provision of patient care.

2.4 Hours of Operation: Hematology operates 24/7, 365 days a year to include Federal Holidays.

2.5 Recognized Federal Holidays:

New Years Day Labor Day Martin Luther King Jr.’s Birthday Columbus Day President’s Day Veteran’s Day Memorial Day Thanksgiving Day Juneteenth Day Christmas Day Independence Day

2.6 Contractor Communication

2.6.1 Government’s COR: The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions: assure that the contractor performs the technical requirements of the contract; perform inspections necessary in connection with contract performance; maintain written and oral communications with the contractor concerning technical aspects of the contract; issue written interpretations of technical requirements, including Government drawings, designs, specifications; monitor contractor's performance and notifies both the CO and contractor of any deficiencies; and provide site entry of contractor personnel. The COR is not authorized to change any of the terms and conditions of the resulting contract.

2.6.2 Post award conference/periodic progress meetings: The contractor agrees to attend any post award conference. At these meetings the CO will apprise the contractor of how the government views the contractor's performance and the contractor will apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues.

2.7 Safety: The Contractor will ensure that its staff conduct operations in a matter that meets industry OSHA safety standards for the protection of DoD staff, patients, and public. The Contractor is responsible for unsafe conditions associated with the actions of its personnel.

2.8 Quality:

2.8.1 Quality Control (QC): The contractor shall develop and maintain an effective QC program to ensure services are performed in accordance with this SOW. The contractor shall develop and implement procedures to identify, prevent, and ensure nonrecurrence of defective services. The contractor’s QC program is how the work complies with stated requirements. The contractor’s QCP must be delivered to the CO within 30 days after contract is awarded. After acceptance of the Quality Control Plan (QCP) the contractor shall receive the CO’s acceptance in writing of any proposed change to this QC system. See Part 6, Attachment 3 - CDRL A001.

2.8.2 Quality assurance (QA): The government will evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan provides a systematic method for the Government to evaluate performance and to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

2.9 Delivery: Delivery instructions will be determined after award. Contractor at a minimum must be able to deliver the Automated Hematology Analyzer System within 30 days after award.

PART 3

3.0 AVAILABLE SERVICES

3.1 Services: The Government will provide the following services below:

3.1.1 Security Forces and Fire Protection: Phone numbers: Non-Emergency Fire Department: 424-3683;

Non-Emergency Security Police: 424-3293. Emergencies (call) 911.

3.1.2 Emergency Healthcare. The MTF will provide emergency health care to save loss of life or limb and preserve undue suffering for contract personnel for injuries or illness occurring while on duty in the MTF.

These services will be billed to the contractor at the current full reimbursement rate through TRICARE.

3.1.3 The space designated for the equipment and supplies will be provided at the Clinical Lab located at David Grant Medical Center, Travis AFB.

3.1.4 The government will furnish all required utilities such as water, telephone, electricity, etc. Long distance and Defense Switched Network (DSN) telephone services will be provided for official use only.

PART 4

4.0 TECHNICAL REQUIREMENTS

4.1 Instrumentation: Contractor shall provide a fully automated hematology system that will meet all the requirements below.

4.1.1 Operating ambient temperature will be 15°C - 30°C (59°F - 86°F) and operating reagent temperature will be 15°C - 30°C.

4.1.2 Maintain relative humidity between 30% and 85%.

4.1.3 Atmospheric pressure normal range will be 70-106 kPa.

4.1.4 Will meet following water requirements:

4.1.4.1 Electric conductivity - 1.0 u S/cm or less

4.1.4.2 Supply Pressure - 0.2MPa - 0.4MPa

4.1.4.3 Supply Volume - 20L/h - 50L/h

4.1.5 Waste will not exceed 4 Gal/Hr.

4.1.6 Will operate using 2 minimum dedicated 20-amp lines @ 117vac terminating in NEMA 5-20.

4.1.7 Sample volume requirement may be less than 100 μl up to 125 μl per aspiration to perform full CBC and Differential reportable test profile.

4.1.8 Will be capable of digital data storage for 1,000 patient tests, 200 QC tests, and 4,000 users.

4.1.9 Must include a pre-dilute sample access mode which requires lower sample volume to perform full hematology reportable test profile.

4.1.10 Must offer reagent storage cabinet for reagents and any peripherals associated with analyzers.

4.1.11 Must have walk away shut down and restart capability.

4.1.12 All systems must provide ability to ‘load and go’.

4.1.13 Analyzer software must have pre-defined, editable rule set on board software.

4.1.14 Pre-defined rule set must indicate ISLH specific rules.

4.1.15 Must offer pre-defined and user-definable rules options for body fluid samples.

4.1.16 Software database must hold a minimum of 100,000 analysis data.

4.1.17 Analyzer PC must be able to identify status and issues related to connected analyzers.

4.1.18 Must have a single aspiration pathway eliminating the need for mode-to-mode QC and/or calibration.

4.1.19 Must be able to offer user-definable rerun and reflex testing based on board or middleware rules.

4.1.20 CPU must include a hard drive and power supply back-up.

4.1.21 The computer system must utilize a Windows 10 or newer operating system.

4.1.22 System will use technology, such as fluorescent flow cytometry for WBC, WBC differential, NRBC, reticulocyte and platelet identification and enumeration or equivalent technology.

4.1.23 System should offer fully reportable, FDA cleared immature granulocyte providing a 6-part differential to help reduce manual differentials, or equivalent technology.

4.1.24 System will offer fully reportable, FDA cleared reticulocyte hemoglobin measurement to assist with anemia management.

4.1.25 System will provide fully reportable, FDA cleared Immature Platelet Fraction to assist with thrombocytopenia determinations.

4.1.26 System will offer fully reportable, secondary on-board platelet methodology to reduce manual reviews, or equivalent technology.

4.1.27 Must provide enhanced body fluid testing capability with the lowest possible linearity.

4.1.28 Must be able to analyze and report results from the following type of body fluids: serous, synovial and CSF.

4.1.29 Body Fluid should provide a WBC, RBC and Total nucleated count with a 2-part differential (polymorphonuclear %/# and mononuclear %/#) with everybody fluid analysis to reduce tech intervention.

4.1.30 Must have a separate mode on system for the analysis of body fluids.

4.1.31 System should have the lowest possible linearity on WBC-BF and Total Nucleated Count-BF linearity (Analytical Measurement Range) on all body fluids of 0.000 - 10.000 x 10^3 / μl and a Reportable Range (Limit of Quantitation) of 0.003 - 10.000 x 10^3 / μl.

4.1.32 Must achieve RBC-BF linearity (Analytical Measurement Range) on all body fluids of

0.000 - 5.000 x 10^6 / μl and a Reportable Range (Limit of Quantitation) of 0.002 - 5.000 x 10^6 / μl.

4.1.33 Must be able to qualitatively indicate (via suspect flag) cell abnormalities with body fluid samples.

4.1.34 Must be able to report RBC & WBC data to three decimal places.

4.1.35 Must provide a NRBC count with every CBC analysis.

4.1.36 Must achieve WBC linearity (Analytical Measurement Range) of 0.0

- 440.00 x 10^3 / μl and a Reportable Range (Limit of Quantitation) of 0.03 - 440.00 x 10^3 / μl.

4.1.37 System should directly measure HCT or equivalent technology.

4.1.38 Must achieve HCT linearity (Analytical Measurement Range) of 0.0 - 75.0% and a Reportable Range (Limit of Quantitation) of 0.1 - 75.0%.

4.1.39 Must achieve PLT linearity (Analytical Measurement Range) of 0 - 5000 x 10^3 / μl and a Reportable Range (Limit of Quantitation) of 2 - 5000 x 10^3 / μl.

4.1.40 System should offer on-board dual technologies - including a fluorescent measurement - for the measurement and reporting of platelets, or equivalent technology.

4.1.41 Must use non-cyanide reagent for Hgb.

4.1.42 Must have no significant intralipid interference up to a concentration of 30.320 OD for WBC.

4.1.43 Must combine flagging information from multiple channels to optimize diagnostic information.

4.1.44 Must offer customizable suspect flags settings capable of making small adjustments to optimize review rates.

4.1.45 Must provide reportable RDW, SD and CV.

4.1.46 Reagent packs must perform at least 400 to 500 tests per container.

4.1.47 Reagent containers must have at least 60 days open stability on all reagents.

4.1.48 Multi Level controls should include all instrument measurements for all whole blood parameters on system.

4.1.49 Control should have the longest possible expiration date to minimize changes to controls.

4.1.50 QC peer group data must have real time electronic data upload capability to analyze quality control.

4.1.51 Instrument should provide reagent concentrate and dilution system to reduce reagent changes and inventory.

4.1.52 Must offer on board reagent monitoring.

4.1.53 Must offer reagent inventory management.

4.1.54 Should have reagent management technology, such as RFID, standard with reagent system.

4.1.55 Must provide 24-hour, 7-days/week access to QC peer review data (IQAP).

4.1.56 Must have the following additional features:

4.1.56.1 Color touch screen.

4.1.56.2 Built-in barcode scanner.

4.1.56.3 Traditional QC with target values assigned to QC materials.

4.1.56.4 Numeric or pass/fail QC.

4.1.56.5 QC prompting, or QC lock out.

4.1.56.6 Abnormal and critical ranges flagged by color highlighting.

4.1.56.7 Canned or free text user comments.

4.1.56.8 Accepting patient ID or accession number.

4.1.56.9 On-screen training mode.

5.1.56.10 Correlation mode.

5.1.56.11 QC program must be flexible for optimum QC data interpretation and manipulation.

4.1.56.12 An expiration date tracking system is a must. It must have lot traceability for all QC material.

4.1.56.13 Must have FDA approval for testing.

4.2 Automation Line: Will provide an automation line that meets the following requirements.

4.2.1 Single point of sample management.

4.2.2 Point-in-space instrument connectivity.

4.2.3 STAT loading/prioritized processing.

4.2.4 Full range of pre- and post-analytic module offerings.

4.2.5 Comprehensive analyzer connections.

4.2.6 Automatic dilution, rerun, and reflex testing.

4.2.7 RFID sample tracking.

4.2.8 Operating temperature between 60-86ºF (16-30ºC).

4.2.9 Relative Humidity: Maximum: 80% at 86ºF (30ºC).

4.2.10 All analyzers must be compatible with automation line.

4.2.11 System should be able to provide a fully integrated instruments capable of workload balancing and maximizing efficiency by operating two analyzers simultaneously.

4.2.12 Must offer the option of automatic rerun/reflex testing on a different, connected analyzer.

4.2.13 System should provide the option of an integrated slidemaker/stainer.

4.2.14 Must also allow scalability option to add modules, as needed, to meet future testing needs.

4.2.15 Must be capable of including a multiple connected and integrated slidemaker/stainer modules, if needed to meet workflow needs.

4.2.16 System would offer option for concentrated reagent dilution system to reduce reagent handling and inventory.

4.2.17 System should include an integrated slide making staining unit and function as part of the line where operator does not have to manually transfer samples and/or rack from analyzer analysis to smear preparation unit.

4.2.18 Must offer flexibility to operate in automation mode (rack) or manual mode (microtainer samples).

4.2.19 Slide maker stainer must have the ability to reduce hazardous waste by recycling stain and methanol.

4.2.20 Must provide automated cleaning mode where operator involvement is minimal <15 minutes per 24 hours.

4.2.21 Must include an open reagent system that provides options for laboratory for different types of stain and buffers to use for system.

4.2.22 Must provide automated troubleshooting and recovery feature in software for better uptime.

4.2.23 Must have ability to automatically distinguish STAT from routine smears to improve smear TAT.

4.2.24 Must offer flexibility to add more than 1 module onto the line, as necessary, to meet laboratory workflow needs and/or provide capacity and redundancy.

4.2.25 Must be intelligent and prepare smears for samples that trigger based on specific analysis result and/or user-defined rule set.

4.2.26 Must be able to automatically make 2 smears on request or 2 or more slides on demand.

4.2.27 Must positively identify sample prior to aspiration and smear preparation.

4.2.28 System will provide the ability to connect directly to a digital imaging device to reduce technologist handling of sample tubes, blood, and slides.

4.3 Data Management System: Contractor will provide a data management system that meets the following requirements:

4.3.1 Enables you to manage test results, patient information, and quality control (QC) data from all connected instruments via a single, centralized workstation.

4.3.2 Data storage for up to 30,000 samples and QC records per interfaced instrument.

4.3.3 Supports simultaneous connections with multiple lab information systems (LIS), including those in different hospitals.

4.3.4 Links automation systems, 32 different instrument connections, and 15 concurrent user sessions.

4.3.5 Integrates and streamlines workflow between hematology, automation, and CellaVision® DM96 and DM1200 Digital Morphology Systems or Scopio for automated digital microscopy using the advanced hematology solution.

4.3.6 Verifies test results collected from analyzers automatically, allowing your staff to focus on only critical results that require immediate attention.

4.3.7 Prioritizes results management for critical patients using customizable, color-coded alerts.

4.3.8 Applies consistent processes automatically to verify normal ranges, QC, delta checks, and instrument flags to help ensure that the right results are released, and the wrong ones are stopped.

4.3.9 Gives you the assurance that every result is automatically examined from multiple angles in a consistent manner.

4.3.10 Helps you deliver higher quality results in less time. With a single click, you can select a test result and directly access the QC information.

4.3.11 Lists all patient samples processed within two QC results.

4.3.12 Shows QC per instrument, across multiple instruments, or per test, across multiple QC levels and instruments, in tabular or graphical formats.

4.3.13 Screens results based on normal ranges, QC Westgard checks, delta checks, and instrument flags.

4.3.14 Provides a graphical view of patient moving averages so you can easily see when QC averages are drifting into a danger zone.

4.3.15 Configuration must have Workstations Up to 15 concurrent user sessions.

4.3.16 Configuration must have instruments Up to 32 devices.

4.3.17 Must have multiple LIS connections.

4.3.18 Must have two LAS connections.

4.3.19 Manages work-order query from instruments.

4.3.20 Acts as a work-order buffer for automation systems.

4.3.21 Uses multiple communication protocols (ASTM, Spec 79, HL7, LMX).

4.3.22 Review/Edit options of Review; all; review none; review by exception.

4.3.23 Review options: Range (definable by age, sex, species, location, etc.).

4.3.24 Provides customizable review of delta checks, QC violations, and instrument flags.

4.3.25 Provides dispositioning options for result entry, result validations, result rerunning, result omitting, result editing, manually entering differential results, and adding comments to results.

4.3.26 Provides the following Quality Control capabilities:

4.3.26.1 Display options for order of results, viewing hematology cytograms, and color codings.

4.3.26.2 Provides quality control data organizable by method, instrument, species, lot, or moving average.

4.3.26.3 Data displayed as results or Levy-Jennings plots.

4.3.26.4 Provides Westgard rules for quality control data (1-2s, 1-3s, 10-x, 2-2s, 4-1s, R-4s).

4.3.26.5 Add comments during quality control review.

4.3.26.6 Support for using comparators (<,>).

4.3.26.7 Omit data from statistical calculations.

4.3.26.8 Configurable interval for automatic QC exports.

4.3.26.9 QC lot auto-creation.

4.3.27 Provides a Search/Query function that allows for specimen searching using Sample ID, Physician name or ID, Patient name or ID, Instrument or instrument group, test, sample status, location, data, time, lab-specific commonly used queries via user-defined buttons, and user definable queries.

4.3.28 Provides security capabilities. These include setting multiple standard and user-defined access levels, as well as Defining menu options for each access level.

4.3.29 User interface Standard Windows navigation via drop-down menus and icons.

4.3.30 Simplified order entry for LIS backup.

4.3.31 Multilanguage support.

4.3.32 Reporting Custom report formats for headers, footers, column headings, and test display order.

4.3.33 Must provide result auto-verification capability, allowing for a customizable ruleset for the automatic verification of results that pass designated requirements.

4.3.34 DMS must have an active ATO for the entire duration of this contract.

4.4 Methods of Monitoring: System will fulfill the following additional requirements:

4.4.1 Must meet maintenance requirements as defined by Manufacturer specifications.

4.4.2 Software must function as defined as defined by Manufacturer specifications.

4.4.3 Must provide secure internet-based system monitoring.

4.4.4 Must offer remote diagnostics capability.

4.4.5 Must provide internet-based interlaboratory quality assurance program.

4.4.6 Must provide automatic notification and documentation of required calibration verification events.

4.4.7 Must provide evidence-based calibration and calibration verification methodology.

4.4.8 Must provide option of manufacturer-assisted calibration verification, either onsite or remotely.

4.4.9 Must provide evidence-based service maintenance methodologies.

4.4.10 Must provide predictive maintenance capabilities.

4.4.11 Must provide rapid, disruption-free and minimal waste generation during automation system installation.

4.4.12 Must provide option of automatic reagent ordering program.

4.5 Operator Training: Contractor shall provide initial and recurring training to technicians on instrument use, maintenance, and troubleshooting. Initial training will be provided to all technicians in person on-site. Recurring training can include a web-based training program available on demand, and quarterly onsite training if necessary. The web-based training program must allow for a staff of 17 to have personalized training plans that are accessed and tracked online; with ability to have training accounts reset for new employees. Web- based training shall include instructions for operation and maintenance of all included equipment. At least quarterly, the contractor will provide a representative to provide hands-on analyzer training to conduct onsite training for one day. Contractor shall provide comprehensive written operating instructions for all aspects of equipment functions (i.e. routine specimen analysis, calibrations, etc.) and training materials to DGMC equipment operators on the daily, weekly, monthly, and as required maintenance when required or requested by the laboratory staff. The service technician must be able to provide additional training in person as needed.

4.6 Instrument Installation and Validation: The Contractor will install, validate and correlate analyzers per College of American Pathologist guidelines at the company’s expense with results approved by Laboratory Medical Director and Hematology Technical Supervisor. Contractor shall set up and validate custom auto-verification rules in middleware based on DGMC laboratory specific requirements. Vendor also provides all validation reagent, calibrators, controls, and consumables needed to perform these tasks during the validation period.

4.7 Initial Inspection: All contractor owned equipment will be inspected and approved by the Biomedical Equipment Maintenance Section prior to use in the Medical Treatment Facility. Contact Program Manager to schedule inspection.

4.8 Shipping Options and Supplies:

4.8.1 The contractor will provide expedited shipping options should emergent needs arise for any supplies provided by the contractor. All supplies and materials necessary for operation of the instrument and performance of all patient testing will be always available to the DGMC lab. If order is placed within the overnight cutoff specified by the vendor, said supply item will arrive within 24 hours to the facility.

4.8.2 The Contractor must provide an estimate of the yearly quantities of reagent/reagent packs, calibrators/standards, and quality control materials required to perform the volume of patient.

reportable tests for each assay as provided in Part 6 Attachment 2 of this SOW.

4.8.3 The Contractor must consider requirements for routine quality control runs (as defined by the Laboratory Director), routine calibration, periodic calibration/calibration verification in accordance with departmental policy and/or the CAP and troubleshooting of out-of-control assays when calculating the requirements.

4.8.4 The Contractor must estimate the volume of user-replaceable maintenance items that will be required to support the analyzer, and any analyzer specific tools/supplies necessary to perform operator-level periodic maintenance tasks. An operator level maintenance tool/spare parts kit will be provided, and replenishment of all expended items made by the contractor at no additional cost to the Government. Replenishment shall be made as needed on a periodic basis not to exceed the normal preventive maintenance cycle.

4.8.5 All reagents must have a minimum unopened shelf life of two (2) months, and controls must have a minimum unopened shelf life of at least two (2) months upon receipt by the Government.

4.8.6 All reagents provided shall be identical to those used in the FDA 510K approval application. All reagents/reagent packs shall be provided as follows:

4.8.6.1 Be provided by the manufacturer of the equipment.

4.8.6.2 Be marked with the required storage temperature.

4.8.6.3 Inclusive of an English language package inserts.

4.8.6.4 If bulk reagents are produced overseas, documentation of item equivalency must be provided.

4.8.6.5 Preservation and packing must be performed in accordance with the best commercial practice and in such a manner to afford adequate protection against damage during shipment from source to destination. All packaging and shipping information shall be clearly marked as to contents on both the shipping documents and the shipping container/box. All routine deliveries will be made Monday through Thursday, to exclude Federal Holidays.

4.8.6.6 Reagents/materials must be maintained at the proper storage temperature during transportation from the Contractor's storage facility to the Government acceptance site and be delivered on time at the appropriate storage temperature.

4.8.6.7 The Contractor will provide, upon shipment, an electronic tracking mechanism whereby the Government is able to identify the shipping status of any materials. Deliveries of required items must be in monthly drop shipments. Orders must arrive no later than one week from the requested date of delivery. Any supplies that are placed on back order shall be communicated electronically to the Government, clearly identified on the shipping documents and delivered in a timely manner, not to exceed ten (10) working days. In the instance a back-order exceeds 10 working days, the Contractor must provide testing services through local sub-contract at their cost.

4.8.6.8 An alternate quality control material must be provided by the contractor if the new lot of controls cannot be delivered one week prior to the expiration date of the lot currently in use.

4.8.6.9 Routine or scheduled orders will arrive no earlier than one week before or later than one week after the scheduled date of delivery. Emergency orders will be delivered within 24 hours after the order is placed.

4.8.6.10 The Contractor shall provide linearity materials for all testing that spans the vendor's published analytical measuring range (AMR) every six-months and as needed to verify repairs per the College of American Pathologist (CAP) inspection criteria.

4.8.6.11 All reagents must be stored at room-temperature or refrigerated. At least 95% of reagents must require no preparation or wait time before being loaded on the analyzer.

4.9 Accessibility and Accuracy: All patient and testing information must be accessible and accurate.

4.10 Regulatory Standards: All services provided shall be performed in accordance with all applicable laws, regulations, standards, local instructions, and commercial practices.

4.11 Service Reporting: Contractor shall furnish a legible service report to the Medical Equipment Repair Center (MERC) personnel, signed off by the department, including the date, time, company name and service representative, contract number, description of malfunction, description of any services performed, and any recommendations necessary to maintain equipment in the best operating condition.

4.12 Report Availability: In addition to furnishing the service reports, the Contractor will store these reports and make them available to the Government at any point during the life of the contract.

4.13 Troubleshooting, Repair, and Maintenance: Troubleshooting guidance and 24/7 telephone service, including on-call emergency repair by a technical expert, will be provided by the contractor 7 days per week from 0500 to 2300, including Federal Holidays and calibration services, not included in routine maintenance, at frequencies specified in the manufacturer’s service and operations manuals, and any required intervening repair service requirements for the entire contract period, including options if exercised. The DGMC lab will be able to reach a live technical support representative within 30 minutes from initial dialing of technical support number. Timelines for Service Technician are listed in 4.13.6.

4.13.1 The Contractor will maintain all equipment installed under this contract except for repairs necessitated by willful damage or negligence on the part of the Government. This includes emergency repairs as well as Preventive Maintenance Services (PMS), safety tests, calibrations/calibration verifications, and unscheduled repair services in accordance with procedures and practices prescribed by the manufacturer of the equipment.

4.13.2 The Contractor must provide a full unscheduled (when equipment breaks down unexpectedly) and PMS throughout the contract. PMS must be inclusive of all costs for the performance of scheduled periodic maintenance (as required by the Contractor's instrument maintenance manuals), unscheduled maintenance and repair of the analyzers and any associated equipment provided by the Contractor as part of the analyzers, including replacement parts, replacement part shipment costs, and service technician travel costs for performance of maintenance services.

4.13.3 Scheduled routine PMS must be performed between 0730-1630 PST Monday-Friday, excluding Federal Holidays.

4.13.4 The Contractor must provide all personnel, equipment, tools, materials, supervision, parts, transportation, and other items and services necessary to perform all required repairs and scheduled preventive maintenance/safety inspections and calibrations of equipment. The performance of scheduled periodic preventive maintenance, safety checks, and calibrations that are not normally performed at the operator level must be performed by Contractor service personnel in accordance with requirements as specified in the Contractor's instrument maintenance manual. Completion of installation of the analyzers will establish time-zero for determining the time frame for performance of periodic services.

4.13.5 Upon notification of equipment failure, the Contractor's qualified service technician must establish telephonic contact within 30 minutes of the Government's notification to the Contractors Customer Service "Hotline."

4.13.6 For equipment supporting the Core Laboratory, the service technician must be on-site to provide unlimited service within twelve (12) hours of establishing telephonic contact. The equipment shall be repaired and operational within 48 hours after initial on-site response by the Contractor. Should the hematology system become inoperable, the Contractor's service technician must be on-site within four

(4) hours of initial notification. The repair of at least one (1) analyzer must be completed within eight (8) hours of initial notification. If deemed necessary, after consultation with the COR, if at least one analyzer cannot be repaired within eight (8) hours of the initial notification, the Contractor shall, where requested, arrange the pickup and delivery of critical specimens to a College of American Pathologists-accredited clinical laboratory, with priority testing service provided for STAT/ASAP specimens. The Contractor shall pay all costs associated with the provision of this alternative testing, including those for delivery of hard copy patient results by express courier, directly to the laboratory, for as long as all analyzers remain inoperable. The Contractor shall provide replacement parts used, as necessary, claimed from local operator-level maintenance kits.

4.13.7 The Contractor must provide all reagents, calibrators, controls and any other materials necessary to troubleshoot analyzer failure at no additional cost.

4.13.8 The Contractor must replace all reagents, calibrators, controls and any other materials used by the Government to troubleshoot instrument failure prior to notification of the contractor.

4.13.9 The Contractor's qualified service technician must ensure all repairs are completed and the analyzer is fully operational prior to departing the laboratory. If repairs cannot be completed the same day, the service technician must contact the COR to discuss the situation and provide an estimated date/time of completion. Once complete, the service technician or Customer Service "Hotline" will verify the repairs corrected the problem and the analyzer is operational in a follow-up call. This call will be made in a timely fashion (not to exceed 24 hours) after the service technician departs the lab.

4.13.10 The Government will make the equipment available to the Contractor for servicing at such time and duration necessary to perform needed repairs.

4.13.11 All work shall be performed in a professional manner by an authorized service representative. If any deficiencies are found due to negligence of the service representative, the Contractor is required to correct the deficiency to a fully operational status in accordance with manufacturer specifications at no additional cost to the Government.

4.13.12 All correspondence, service reports, and invoicing shall be in English.

4.13.13 Preventive maintenance services shall be performed in accordance with the manufacturer's standards/procedures. A preventive maintenance service shall include, but is not limited to, safety, calibration or calibration verification (as appropriate), complete operational testing, lubrication, adjustments, and cleaning of equipment to which the operator does not have access. This also includes the installation of all non-operator parts required to ensure proper operation.

4.13.14 The Contractor shall notify the COR of the exact date and time for performance of a preventive maintenance service no later than ten (10) days prior to the scheduled preventive maintenance services.

4.13.15 Prior to performing Scheduled Maintenance and Unscheduled Repair Services work, the Contractor's representative shall comply with current vendor reporting procedures at David Grant Medical Center.

4.13.16 Within one (1) working day after completion of a repair, the Contractor's representative shall furnish the COR one (1) copy of a service report for all services performed with a copy to the Equipment Management Branch and the Laboratory Representative for the MTF. The report shall be in English and shall contain, as a minimum, the following information: Nomenclature and serial number, date, description of services performed, duration, location, list of parts or other actions taken to restore operability, and name of technician.

4.14 Charges for Service: The Contractor shall bill for services rendered in accordance with the CLIN Structure and Approved Price List.

4.15 Uptime: Systems must function with a 100% up-time and ability to perform patient testing 100% of the time. This pertains to having dual platforms. If there is a single platform, up-time and patient testing must be at 99%.

4.16 Standards of Performance: The analyzer must meet the characteristics of performance for precision and accuracy defined by 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).

4.17 Standardized Offerings: Must provide standardized offerings (Standing orders for reagents and controls).

4.18 Alerts: The analyzer must have a method of audibly or visually alerting the operator for sudden out of range quality control.

4.19 Quality Control Fail-Safe: The analyzer must prevent results from entering the patient record in the event of failed quality control.

4.20 Dimensions: The analyzers and automation solution must fit within a 15 ft X 4 ft space while allowing for multiple operator movement, reagent storage, and bench space. Further, the analyzer must be able to navigate through doorways that are 42in wide by 83in tall.

4.21 Reagent Handling: All reagents must be stored at room-temperature, refrigerated, or frozen. At least 95% of reagents must require no preparation or wait time before being loaded on the analyzer.

4.22 Removal of Equipment: Should the equipment or any component listed herein require repair at the contractor’s plant, contractor shall obtain a signed authorization from the COR authorizing removal of government equipment. Contractor shall not remove any equipment until loaner/replacement installed on-site. Contractor shall be responsible for damage or loss of equipment while in contractor’s possession.

4.23 Upgrade of Equipment: Subject to mutual agreement between the Government and the Contractor, instrumentation may be upgraded within the specifications of the contract as new technology becomes available. Additionally, the Government will add reagents through the life of this contract as a result of advances in technology or changes to clinical practice standards. Any such change to the reagents shall be mutually agreed upon by the contractor and the Government through a bilateral modification.

4.24 Testing Availability: The contractor will provide a minimum volume of the testing amounts described in Part 6, attachment 2. The contractor will offer options to add more hematology testing if more is needed beyond this estimated volume.

4.25 Weight: Weight will not exceed 1,089kg (2,400 lb.).

PART 5

5.0 DEFINITIONS/ACRONYMS/PUBLICATIONS/HIPAA

Definitions:

Contracting Officer (CO): A person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings.

Contracting Officer’s Representative (COR): An individual, including a contracting officer’s technical representative (COTR), designated and authorized in writing by the CO to perform specific technical or administrative functions. This individual does NOT have authority to change the terms and conditions of the contract.

Nonpersonal services contract: a contract under which the personnel rendering the services are not subject, either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees.

Quality Assurance Surveillance Plan (QASP): An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance. The Government may either prepare the QASP or require the offerors to submit a proposed quality assurance surveillance plan for the Government’s consideration in development of the Government’s plan.

Acronyms:

AFB Air Force Base ATO Authorization To Operate CAP College of American Pathologists CBC Completed Blood Count CLIA Clinical Laboratory Improvement Act CLSI Clinical and Laboratory Standards Institute COR Contracting Officer Representative COR Contracting Officer

CSI Construction Specifications Institute CV Coefficient Variation DGMC David Grant Medical Center DHA Defense Health Agency DMS Data Management System DOD Department of Defense FDA Food and Drug Administration HCT Hematocrit Test IQAP Interlaboratory Quality Assurance Program

International Society for Laboratory ISLH Hematology IT Internet Technology LIS Laboratory Information System MERC medical Equipment Repair Center MTF Military Treatment Facility NEMA National Electrical Manufacturers Association NRBC Nucleated Red Blood Cells

Occupational Safety and Health OSHA Administration PMS Preventive Maintenance Services POP Period of Performance

QASP Quality Assurance Surveillance Plan QC Quality Control QCP Quality Control Plan RBC Red Blood Cell RDW Red Cell Distribution Width RFID Radio Frequency Identification RFP Request for Proposal RFQ Request for Quote SOW Statement of Work SD Standard Deviation

APPLICABLE PUBLICATIONS

The Contractor must abide by all applicable regulations, publications, manuals, and local policies and procedures outlined in the SOW.

Applicable Publications

Applicable Publications (Current Editions): The Contractor shall abide by all applicable regulations, publications and manuals. Following is a list of basic publications applicable to the SOW. The most current version of the publication applies. Publications not on the internet or MTF policies and procedures can be obtained from the MTF. Current issues of publications and links to other service publications can be accessed at the following websites:

http://www.apd.army.mil/ http://www.defenselink.mil/pubs http://www.dtic.mil/whs/directives/ http://www.e-publishing.af.mil

Contractors are obligated to follow these codes as mandatory only to the extent that they apply to the contract.

Supplements, amendments, or changes to these mandatory publications may be issued during the life of the contract.

Advisory publications may be used for information and guidance but are not binding for compliance.

DEPARTMENT OF DEFENSE (DoD) REGULATIONS/MANUALS

INSTRUCTIONS/DIRECTIVES

PUB NO. TITLE

DoDD 5500.7 Standards of Conduct DoDI 5400.7-R Freedom of Information Act DoD 6025.18-R Health Information Privacy Regulation Jan 03 DoDD 8500.1 Information Assurance DoD 8580.02-R HIPAA Security Rule DODI 3020.37 Continuation of Essential DOD Contractor Services During Crises AFI 33-332 Air Force Privacy and Civil Liberties Program DHA-IPM 18-013 Interim Procedures 18-013 Risk Management Framework (Cyber RMF) DHA-IPM 18-013 Interim Procedures 18-013 Risk Management Framework (Cyber Services)

AIR FORCE INSTRUCTIONS/MANUALS

Publications Code:

AFI--Air Force Instruction AFMAN--Air Force Manual AFP--Air Force Pamphlet AF Form--Air Force Form DD Form--Department of Defense Form MDGI - Medical Group Instruction

Pre-Market Approval Section 510(k) of the Food, Drug and Cosmetic Act requires In Vitro device manufacturers to register with the FDA at least 90 days in advance of their intent to market a medical device. This is known as Premarket Notification - also called PMN or 510(k). Must be in compliance with Section 510(k) of the Federal Food, Drug, and Cosmetic Act for those medical device products intended to be delivered to the Government. Only devices that have received Premarket Notification Approval from the U.S. Food and Drug Administration (FDA) shall be considered for award under this solicitation.

PART 6

6.0 ATTACHMENTS/TECHNICAL EXHIBIT LISTING

PART 6, ATTACHMENT 1

PERFORMANCE REQUIREMENTS SUMMARY

The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

Performance Objective

Ref Performance Threshold

Method of Surveillance

Procedure

(PRS) # 1

The contractor shall provide a Coagulation system that functions with a 99% up-time and ability to perform patient testing 99% of the time.

SOW

Part 4, Section 4.15

99% Uptime 100% Inspection 100% evaluation of any instrument downtime resulting in complete or partial loss of testing capability.

(PRS) # 2

Must have technical support available 24/7, 365 days per year.

SOW

Part 4, Section 4.13

100% Availability within 30 Mins always.

100% Inspection 100% investigations of any instance in which the DGMC Laboratory is unable to reach a live technical support representative within 30 minutes from initial dialing of technical support number.

(PRS) # 3

Analyzer meets characteristics of performance for precision and accuracy as defined by 1988 CLIA and CLSI.

SOW

Part 4, Section 4.16

100% Met 100% Inspection 100% inspection of any failure to meet precision and accuracy assessments.

(PRS) # 4

Maintain records of maintenance and instrument service.

SOW

Part 4, Section

4.11 - 4.12

100% Record Upkeep

100% Inspection 100% Inspection of all service reports following receipt of service from Contractor.

(PRS) # 5

All supplies and materials available for the laboratory.

SOW

Part 4, Section 4.8

100% Availability

100% Inspection 100% inspection of any instance in which the DGMC laboratory loses any testing capability due to inaccessibility of supplies or materials.

(PRS) #6

Maintain training requirements annually for each piece of equipment.

SOW

Part 4, Section 4.5

90%, Ensuring an alternative is given when normal means of training are not available

Periodic Inspection

Periodic surveillance of laboratory personnels’ competency with equipment.

(PRS) #7

Preventive maintenance specified as not performed by end-user is upkept by the contractor and always performed within its recommended timeframe.

SOW

Part 1, Section 1.3.6

100% Performed On Time

100% Inspection Periodic surveillance of preventative maintenance records, ensuring the timely performance of preventative maintenance within the manufacturers recommended timeframe.

PART 6, ATTACHMENT 2

ESTIMATED WORKLOAD DATA

ITEM TEST NAME ESTIMATED ANNUAL

QUANTITY

1 CBC with Differential 28,110

2 CBC (Without Differential) 1,348

3 Reticulocyte Count 237

4 Body Fluid Cell Count with Differential 269

PART 6, ATTACHMENT 3

DELIVERABLES SCHEDULE

Deliverable Frequency Medium/Format Submit To Applicable to:

Mission Essential Plan

Delivered within 30 days after award

DGMC COR & 60

CONS/CO

All

Implementation plan and Schedule

Delivered within 30 days after award

DGMC COR & 60

CONS/CO

All

CDRL A001 -

Quality Control Plan

DD Form 1423-1

Within 30 days of task order award

Contractor’s discretion CDRL A001 to CO All

PART 7

7.0 HEMATOLOGY ANALYZER INSTALLATION

7.1 Facility modification for the Hematology Analyzer System is not anticipated. However, if required, prior to any facility modifications, the Contractor will present the final plans and cost estimates with a detailed statement of work to Facility Management (FM) office for review. These shall be presented in accordance with the Construction Specifications Institute (CSI) 50-division format with standardized divisions with all costs broken out. The final quotation shall include all site preparation, construction, extended installation, incidental services, labor, shipping, supplies, materials the Contractor will be responsible for to provide a fully operational turn-key system, meeting all minimum requirements and essential characteristics specified in the Statement of Work (SOW). Contractor will also provide visual representations (red-line drawings, drafts, diagrams, mock-ups, screenshots, etc.) to FM for review.