2-Exhibit A - Statement of Objectives Heme Final.docx

Statement of Work For University Medical Center of El Paso

4815 Alameda Ave. El Paso, Texas 79905

Hematology

1. Scope of Work (SOW):

The contactor shall provide all personnel, equipment, tools, materials, startup reagents, supervision, transportation, service/operator's manuals and other items and services necessary for the installation of the Hematology Analyzer(s) and ancillary equipment in the Laboratory in full support of the validation and implementation of clinical testing. Hematology testing would be under a Cost Per Reportable Result (CPRR) Agreement. This CPRR Agreement includes Instrumentation, Ancillary Equipment, Water Systems, Middleware (Hardware and Software including Consulting Services required in developing, validating, and implementing features), Training, Maintenance, Service, Repairs, Parts, Labor, Materials, and Inventory Management System for all required supplies, installation, continued maintenance support, and removal of equipment when the contract ends at University Medical Center, El Paso, TX and outlying clinic locations where instrumentation is placed (listed elsewhere in this SOW).

Middleware should be included where a set of laboratory-established algorithms are applied to stop auto validation of any result not meeting the criteria of the algorithm. Criteria include but are not limited to sample integrity flags, delta checks, immediate/critical action values, and results that are appear incompatible with pathophysiological processes (i.e., absurd results).

Results must be held at the vendor middleware interface level for tech- review and appropriate follow-up action. Middleware must be housed on a Virtual Server/physical and have the capability to link to outside clinic facilities to provide same middleware service as the main lab. Middleware must have the capability to link to Softlab with reimbursement for interface. Contractor shall comply with current National Electric Code (NEC), National Fire Protection Association (NFPA) standards, and all Environmental and Safety codes, CAP, CLIA, FDA, laws and regulations.

1.2 Description of Work:

The Contractor shall provide Hematology testing as a Cost Per Reportable Result (CPRR) agreement to include equipment, reagents, tools, materials, training, water purification system, automation to create peripheral smears when flagged by the instrumentation (e.g., instrument specific computer terminals and CPUs, printers, etc.). Uninterruptable Power Supply (UPS), Robotic Automation Systems, Automated Pre-analytical Processing Systems, Bidirectional Track, and Automated Post-analytical system and services necessary to meet the Hematology testing and analysis requirements for University Medical Center, El Paso, TX and its outlying clinics UMC Far East Emergency, UMC Far West Clinic, UMC Surgical Hospital and UMC Ysleta Clinic. The main analyzers shall be located in the Main Laboratory of University Medical Center, El Paso, TX Alberta Ave El Paso, TX 79905 and lower-volume testing analyzers will be located at the UMC clinics. Contractor shall include/provide delivery, installation, all calibrators, standards, reagents/reagent packs, and quality control materials necessary to meet requirements for validation, implementation, and clinical testing needs of the institution, providers, and patients.

The offerors product solution shall provide testing redundancy (to ensure continuous operations), training for testing and supervisory personnel, operational supplies, support and/or guidance for scheduled/preventative as well as unscheduled maintenance for all equipment.

The vendor will support Initial Method Validations per Clinical Laboratory Improvement Amendments (CLIA)/National Committee for Clinical Laboratory Standards (NCCLS)/Department of Pathology guidelines, to include method correlation, linearity verification to maximum dilution, precision, carry-over, sensitivity, specificity, interference studies, normal/reference range validation, and blood collection tube validation, initially and with each new assay and/or conversion. The contractor will work with the laboratory director and/or technical director to develop validation study criteria prior to the start of validation testing. Subsequent to validations, the contractor shall provide review to the Director for acceptability and approval of all assays prior to proceeding with Clinical Testing in real-time for all Hematology instrumentation. The contract includes analyzer decontamination when necessary and removal of all instruments at the termination of the contract. The hematology analytical systems shall provide users with rapid, reliable test results that meet the needs of our patient care operations. The Contractor shall be responsible for maintenance service, on-site repair and parts as required in order to maintain a minimum 99% uptime for all instrumentation. All testing materials to include reagents, equipment, consumables and products associated with testing, must be FDA approved for the platforms. All costs will be calculated on a cost per reportable result based on estimated patient volume and test type listed in Appendix A with a projected volume increase of 2% per year throughout the contract.

Appendix A Lists of Tests and TaE

Neutrophil (10˄3/µL) +/-3 SD Neutrophil (%) Lymphocyte (10˄3/µL) +/-3 SD Lymphocyte (%) Monocyte (10˄3/µL) +/-3 SD Monocyte (%) Eosinophil (10˄3/µL) +/-3 SD Eosinophil (%) Basophil (10˄3/µL) +/-3 SD Basophil (%)

2.0 Hematology Instrument

The contractor shall provide Hematology equipment that is fully automated, a quantitative automated hematology analyzer for in vitro diagnostic use in determining whole blood diagnostic parameters and body fluid diagnostic parameters. Instrument must have NRBC testing on every CBC to reduce the need of reflex testing or performing automated/manual differentials. The instrument should not need to correct WBC when NRBC when they are detected and should have an automated IG count and percentage with every automated differential to reduce manual review rates. The instruments must have the flexibility for routine and STAT testing. The analyzer must be able to load samples, reagents, consumables and empty waste while the analyzer is running and also must have automatic rerun capability to extended times or higher/lower dilutions and auto reflex to rerun as needed. Instrument should have the capability but not limitation to stain platelets to reduce interferences between RBC and WBC fragments. Instrument would need to have the capability for onboard decision rules, network printer, and status alert lights. Examination of the numerical and/or morphological findings of the complete blood count by the physician are useful in the diagnosis of disease states such as anemias, leukemia’s, allergic reactions, viral, bacterial, and parasitic infections. The system shall be capable of performing all of the required tests and assays listed in Appendix A, pre-analytical processing, sorting, and post-analytical storage. All equipment displays and supporting literature must be in the English language. The specifications of the system must be able to perform patient testing using whole blood to perform the following fully automated tests and provide histograms: White Blood Cell count (WBC), Red Blood Cell count (RBC), Hematocrit (HCT), Hemoglobin (HGB), Mean Corpuscular Volume (MCV), Mean Corpuscular Hemoglobin (MCH), Mean Corpuscular Hemoglobin Concentration (MCHC), Platelet count (PLT) , Nucleated Red Blood Cell (NRBC) %, Red Cell Distribution Width (RDW-CV), Red Cell Distribution Width (RDW-SD)Mean Platelet Volume (MPV), Neutrophil (NEUT) absolute (#), percent (%); Lymphocyte (LYMPH) #, %; Monocyte (MONO) #, %; Eosinophil (EO) #, %; Basophil (BASO) #, %; Immature Granulocytes (IG) %, Reticulocyte (RET) %, Immature Reticulocyte Fraction (IRF), Reticulocyte Hemoglobin (RET-He), IPF, WBC-BF, RBC-BF, MN, PMN, TC-BF#.

2.1 Instrument Throughput

Instrument should be able to process up to 100 CBC+Diff samples/hour per module and up smear up to 40 peripheral samples/hour per module 24/7.

2.2Sample Aspiration Volume and sample aspiration capabilities Instrument should have the capability of aspirating whole blood of a minimum of 165 µl, Pre-dilute 70 µl, and Body Fluids of 90 µl. The system must have the capability of being able to perform dilutions on whole blood and body fluids. Also the system must be able to perform fully automated testing on body fluids with no additional dilutions required prior to testing. Retic parameters must be a one-step method and not require any additional dilutions prior to testing.

2.3 Sample Linearity

Sample Linearity should include but not limited a minimum to criteria in Apppendix B for both low and High values:

Appendix B WBC: 0.050 – 440.00 x10˄3/µl RBC: 0.005 – 8.50 x10˄6/µl PLT: 0.00 – 5,000 x10˄3/µl WBC-BF: 0.000 – 6.000 x10˄3/µl RBC –BF: 0.000 – 5.000 x10˄6/µl

2.4 Calibration and Quality Control

Contractor shall provide/manufacture calibration material that that will help maintain top instrument performance at a minimum bi-annually and provide/manufacture quality control capable of detecting any instrument malfunction that may require service and instrument re-calibration. Vendor Quality control must be a complete tri-level QC product for all CBC, Diff, PLT, and Retic parameters. Vendor must also provide/manufacture a bi-level quality control product for body fluid channel. Instrument must have capability for comprehensive QC filing for current and new lot. It must also have a web based inter laboratory quality assessment program along with a web based quality monitor that consolidates the platform for quality control monitoring. Quality Control program would need to have configurable Westgard/multi- rules.

2.5 Instrument Middleware

Contractor must provide a data management (physical or virtual) and processing solution that delivers auto-validation support with customizable workflow rules with multi-site/ multi-LIS environment. Turnaround Time status indicators, with sample location tracking and validation solution software. The middleware workflow solution would be HIPPA compliant, protect health information access control, automatic security patches, directory services for user management, disaster recovery, and a database backup recovery (Cloud based or server). On board standard operating procedures would guides techs through complex workflows when auto validation is not possible. Middleware rules would include but limited to SOP for WBC rules to detect Blasts, Left shifts, Atypical Lymphs, WBC/RBC/PLT critical, WBC/RBC/PLT linearity high or low, Critical WBC abs count, deltas, instrument errors, Retics, etc. Middleware should be compatible with softlab and have the capability of holding and releasing results into softlab LIS. Middleware should have directory password services management for role specific access, and software security monitoring. Middleware should have multi-site/multi-LIS environment that allows for standardization across multiple sites and allow customizable workflow screens. Middleware should also have agile software updates along with 24/7 technical support with an assigned project management and specialized consultation services at the time of implementation for any follow up consultation. Middleware should come with analyzer connections necessary to connect equipment to middleware, unlimited users for the middleware, software updates, database/application support, sample space storage, and unlimited online training for new employees. Also middleware should have a configuration tool and auto-verification packet with prewritten rules that help new customers setup rules for testing. Establish Moving Averages (Average of Normals) protocols to identify trends that may affect patient results. An LIS allowance would need to be placed in the contract to help aid in the licensing connection fee from the vendor middleware to UMC Soflab LIS for the main lab and all of it outlining clinics. Middleware should have windows 10 compatibility with the ability to update to any window based software the Lab LIS would need for software compatibility and connectivity.

2.6 Reagent Management

The analyzer must have a reagent barcode reader and the reagent bar-coding tracking should include material name, lot number, expiration date, vial size and onboard volume. Instrument would need have an Inventory management solution and a color coding container system to help reduce operator reagent error loading. The contractor shall deliver reagents no later than seven calendar days following request for products/supplies. Standing Order schedules for routine delivery of supplies to be defined by the Laboratory with no additional charges for revisions. Contractor shall assign a Point of Contact for the Laboratory to order through. The contractor shall sequester the required calibrator, quality control material, and reagents to ensure no more than (6) lot changes per contract year. The analyzer shall have the on-board ability to maintain reagents at the proper storage temperatures for the assays listed in Statement of Objectives. All assays must be FDA approved for the specified testing.

2.6.1 SHIPPING AND HANDLING:

The contractor shall provide all manufacturer brand reagent and controls necessary to meet the average monthly test volume. These reagents and controls must be provided on a mutually-agreed, pre- determined shipping schedule for the assigned monthly sample volume at no additional cost. Adjustment to any monthly shipment of reagent and controls in order to allow for adequate inventory must be allowed. A schedule of routine shipments shall be provided along with a shipping mode based on geographical location. All shipments of reagents/control materials will have the same lot numbers and expiration dates; the expiration date will be at least 6 months after the date of delivery and the shipment must arrive by the 15th day of the month. The mode of shipment used shall be appropriate for the product being shipped to arrive within manufacturer's specifications. The shipment of temperature controlled products that are restricted from shipping over weekends and holidays shall be sent to arrive during normal business hours.

2.7 Water Filtration system

If a DI water system is needed for the instrumentation the contractor would provide allowance for the DI water filtration system.

3.0 Integrated Slide Processing System

The instrument shall include a cell image analysis capability for peripheral smears. This system would be an automated digital cell morphology system providing complete automation of the manual WBC differential process, RBC morphology, and Platelet estimation and analysis. The cell image automation system should have the capability of being able to interpret instrument/middleware rules and flags that would reflex samples for an automated differential. The system would have the capability for automatic cell location and pre-classification functions for performing differentials. Instrument would have light indicators to aid techs in replacing reagents. The instrument would be covered by 24/7 technical/remote support and instrument service available if needed. The peripheral blood smear and stain system should be able to produce a minimum of 40 slides per hour.

4.0 Hematology Automation

Contractor must have instrumentation that is compatible with the Roche Cobas 8100 automation Line. Hematology automation should have a conveyor extension, and turn unit capable to fitting onto the Roche Automation platform to go around fixed objects and allow flexibility. Hematology automation would have barcode readers to track and follow samples across the line. The automation would have the capability of reading patient samples with a receive function and capability to send the receive information to the Softlab lab LIS system. Automation would have a tube sorter option for hands free pre- and post- analytical lavender top management. The tube sorter should have the capability of holding a minimum of 500 tubes at room temperature. The automation would have a bi-directional lane that would have the capability of sending samples back for re-run, pull samples for manual review, or send back to the automatic slide maker for a peripheral smear. Hematology automation would have 24/7 technical/remote support with onsite instrument service available if needed. The automation preventive maintenance down time shall not exceed 30 minutes. All IPUs and hardware must have windows 10 compatibility with the ability to update to any window based software the Lab LIS would need for software compatibility and connectivity. This would also include all instrument hardware and software updates. Instrument automation allowance would need to be placed on the contract for any fees incurred to connect the vendor instrumentation onto the ROCHE Cobas 8100 automation line.

5.0 Instrument footprint and quantity

The total number of analyzers shall be determined by the minimum throughput in Appendix B, patient volumes, ability to continually operate for 12-hrs without having to stop to load reagents or consumables, and must fit within available space without any structural changes to existing floor plans. This is inclusive of secondary/external equipment that is not a component of primary testing, processing, or storage, such as compressors or ventilation systems to drive pre-analytical processes. In the event that secondary or external equipment is not included in the primary system layout due to laboratory space and/or contributory distractors to patient testing/care such as heat and/or noise, the vendor shall provide this information and any associated specifications. Instrument redundancy would need to be in place for continuous result reporting when one of the instruments is down for UMC main lab. Each instrument would need to have its own operation system/unit for instrument management.

5.1 Instrument Quantity

All analyzer shall be at random/open access, discrete analyzer system with STAT interrupt capability and a primary tube sampling system capable of handling 75mm x 13mm, and 46mm x 10mm (microtainer) test tubes with standard or Hemogard caps and screw caps. The analyzer shall be capable of accommodating both Becton-Dickinson, Starstedt, and Greiner tubes type validations.

5.2Instrument Performance These analyzer systems shall be capable of performing in low, medium, and high volume work periods to produce results that are accurate and precise.

6.0 Maintenance and Service

The Contractor shall be responsible for furnishing maintenance, services, repairs, and parts as required in order to maintain the systems at all locations at a 99% uptime guaranteed. The Contractor shall provide all reagents, calibrators, controls and any other materials necessary to troubleshoot and remedy the reasons for the analyzer failure or malfunction at no additional cost to UMC.

6.1 Customer Support

The Contractor shall provide direct customer service for all sites and support, 24 hours/7 days a week, to include hotline telephone service (provided in English) and on-call emergency repair service support, to assist operators in correcting equipment operation and IT issues. Engineering Service will be provided when issue is not able to be resolved over the phone.

6.2 Engineering Services

The Contractor shall provide repair service response within 1 hour and technician arrives within 12 hours after notification for routine (i.e., issues that do not result in complete / and 4 hours after emergency failures. The Contractor’s qualified service technician shall be on site to provide routine services; safety checks, service requiring immediate repair; scheduled services for preventive maintenance, and calibration as specified in the Contractor’s instrument maintenance manual. The equipment shall be repaired and operational within 24 hours after initial documented request by the Laboratory to include weekends and holidays. Contractor shall provide two (2) paper and two (2) electronic copies of the Operator’s and Maintenance manuals and a statement of the warranty terms in the English language for each location. The level of detail required of appropriate instrument maintenance manuals extends only to routine maintenance procedures performed by the user. All instrumentation specified is leased equipment that is provided, serviced, and maintained by the Contractor. Contractor shall provide adequate service support for the following areas; decontamination, relocation, installation management, Lab Process consultants for pre and post workflow analysis, IT Project management for IT implementations and on-going initiatives. Contractor shall provide One (1) Base year with six (6) Option Years. Receive two (2) preventative maintenance visits each year with 48 hour notice prior to arrival. The contractor shall be responsible for all parts required to maintain a serviceable system. The contractor shall provide the customer with service required to maintain the instrument, contractor provided computer, and software at its full capabilities for the term of this agreement at the business hours agreement stated below. If a replacement system is needed before the end of the term, the contractor will provide a replacement at no cost to University Medical Center. The system replacement will take place after the manufacturer has exhausted its troubleshooting options through its service escalation process. When necessary repairs, maintenance or service are completed, the contractor's representative will supply the laboratory with a written report explaining the repairs/maintenance performed prior to departing the facility. Additionally, the contractor's representative must check out with the Supervisor or charge and provide a documentation of all work accomplished. The contractor shall maintain the work area in a clean condition by the end of the contract performance period. Contractor shall dispose of all waste at an off-base permitted disposal site.

6.3 ENVIRONMENTAL COMPLIANCE:

The contractor shall be responsible for the removal and disposal of any hazardous waste products generated by the contractor. The contractor shall prepare all disposal manifests for hazardous wastes or chemicals. Contractor shall obtain signatures from the Base Environmental office of any hazardous waste disposal prior to removal of items off the UMC.

6.4 GENERAL INFORMATION:

When the contractor representative is working in a potential infectious area of the laboratory, they must wear a lab jacket/coat and gloves which will be provided. The contractor must provide all instrument freight charges incurred to have the instrument delivered for installation.

6.5 APPEARANCE:

Contractor's personnel shall present a neat appearance and be easily recognized. This may be accomplished by wearing distinctive clothing bearing the name of the company or by wearing appropriate badges, which contain the company and employee's name. The wear of open-toed shoes is prohibited for infection control purposes.

7.0 Telecommunications

Systems that provide the ability to control instrument software from remote locations are required. All Contractor systems that communicate with the UMC systems shall interconnect through the established portals, Virtual Private Network (VPN), and/or Business to Business (B2B) gateway. For all Web applications, Contractors shall connect to a UMC system approved route. All software must be able to pass IT requirement testing and review and be awarded a Certificate of Networthiness (CoN) from NETCOM. Submission of the CoN must be completed within six (6) months of contract award.

7.1 Internet Service Provider

In accordance with contract requirements, Contractors shall connect to the B2B gateway via a Contractor procured Internet Service Provider (ISP) connection. The Contractor shall assume all responsibility for establishing and maintaining their connectivity to the B2B gateway. This shall include acquiring and maintaining the circuit to the B2B gateway and acquiring a Virtual Private Network (VPN) device compatible with the MHS VPN device. All costs for VPN hardware and software shall be incurred by the Contractor.

7.2 BUSINESS TO BUSINESS (B2B) PARTNERS AND 3rd PARTY VENDORS – The Contractor shall establish appropriate administrative, technical, and physical safeguards to protect any and all data, to ensure the confidentiality, integrity, and availability of UMC data. As a minimum, this shall include provisions for personnel security, electronic security and physical security as listed in the sections that follow. Vendors must insure ability to conform to all standards set forth by UMC Risk Management Framework.

8.0 Training

The Contractor shall provide training for Six (6) operators total at the Contractor’s training site, prior to delivery and installation of the analyzer and two (2) slots annually thereafter with each option year at no additional cost to the UMC. The Contractor shall provide initial on-site operator training to all technicians assigned to the UMC lab site prior to initiation of use of the analyzer for patient testing. Periodic Advanced Operator Training/Education must be offered for all levels of staffing (i.e. Manager/Supervisor, Operations-Technical, and Information Systems). Contractor shall provide Information Technology type training (e.g. Rules Writing) for one (1) operators or IT personnel per year starting with Base Year and annually thereafter with each option year. Periodic Advanced Operator Training/Education must be offered for all levels of staffing (i.e. Manager/Supervisor, Operations-Technical, and Information Systems).

9.0 Administrative Requirements

Within 10 working days after contract award, Contractor shall coordinate and conduct a post award site visit for the purpose of coordinating schedule for equipment installation. Additionally, the installation of equipment may need to be performed in a phase process at no additional cost to UMC.

9.1 SDS Sheets

The Contractor shall provide safety data sheets (SDS) for each item delivered under this contract considered to be HAZARDOUS MATERIAL by UMC. The SDS shall contain information on the hazards associated with each specific chemical or material. The SDS shall be printed in English and shall contain at minimum the following information: identification of specific hazard, the required practice for safe use of the product, first aid procedures, and what to do in the event of a spill or other mishap or accident.

10.0 Delivery and Installation of Equipment:

The Analyzers shall be delivered to the location(s) as indicated below.

· University Medical Center (Main Lab) 4815 Alameda Ave El Paso Texas

· UMC Far East (FEED) 1521 Joe Battle Blvd, El Paso Texas

· UMC Northeast ED(NEED) 9839 Kenworthy St El Paso Texas

· UMC Ysleta Clinic 300 S Zaragoza Rd El Paso Texas

· UMC West Clinic 6600 N Desert Blvd El Paso Texas

· UMC Surgical Hospital 1416 George Dieter Dr El Paso Texas

· University Medical Center (Stat Lab) 4815 Alameda Ave El Paso Texas

Timelines to be established no later than the post-award conference. Equipment setup, on-site training, review and set up of initial Method Validations per CLIA/NCCLS/UMC/TTUHSC guidelines, to include method correlation, linearity verification to maximum dilution, precision, carry-over, normal reference range validation, serum/plasma and blood collection tube validation, shall be started by within 90 days of contract award to ensure that equipment is fully operational within determined timeline. During the initial implementation, a dedicated technical representative must be available onsite throughout the entire implementation period and during go-live. Expected completion of installation and implementation is 90 days. The instrument must be on site at least 90 days prior to the old analyzer being removed to ensure all system/method validation studies are completed to provide continuous patient care services. All tested analytes shall fall within TaE provided by CAP in order to be considered ok for patient testing as listed in Appendix A.

10.1 PRIMARY LOCATIONS OF COMPLETE SYSTEMS

UMC Surgical Hospital 1416 George Dieter Dr El Paso Texas University Medical Center (Stat Lab) 4815 Alameda Ave El Paso Texas

11.0 Hours of Operation

· University Medical Center (Main Lab) Mon-Sun 0000-2400

· UMC Far East (FEED) Mon-Sun 0000-2400

· UMC Northeast ED(NEED) Mon-Sun 0000-2400

· UMC Ysleta Clinic Mon-Fri 0800-1800

· UMC West Clinic Mon-Fri 0800-1800

· UMC Surgical Hospital Mon-Sun 0000-2400

· University Medical Center (Stat Lab) Mon-Sun 0000-2400

Appendix B Volumes for 2025

Appendix C Relevant CLSI Standards Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard (AUTO01-A) Laboratory Automation: Bar Codes for Specimen Container Identification; Approved Standard (AUTO02-A2) Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard—Second Edition (AUTO03-A2) Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard (AUTO04-A) Laboratory Automation: Data Content for Specimen Identification; Approved Standard (AUTO07-A) Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard (AUTO09-A) Auto verification of Clinical Laboratory Test Results; Approved Guideline (AUTO10-A) IT Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard (AUTO11-A) Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline— Third Edition (C28-A3) Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition (EP05-A2) Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline (EP06-A) Interference Testing in Clinical Chemistry; Approved Guideline—Second Edition (EP07-A2) Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline—Second Edition (EP09-A2) Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures; Approved Guideline-Third Edition (EP10-A3) Laboratory Statistics — Standard Deviation; A Report (EP13-R)