Attachment 1 SOW Sysmex Hematology Analyzer.pdf

673d Medical Group Laboratory

STATEMENT OF WORK (SOW)

FOR THE

HEMATOLOGY ANALYSIS

Sysmex XN3100

JOINT BASE ELMENDORF-RICHARDSON, AK

673MDSS/SGSL

May 2024

TABLE OF CONTENTS

SectionTitle

1.0 Description of Services

2.0 Government and Contractor Furnished

Property and Services

3.0 General Information

SECTION 1

DESCRIPTION OF SERVICES

1.1 Scope of Work: Multiple hematology analyzers capable of performing on-board standard hematology, integrated units. Each analyzer must be adapted for and must meet the specific testing workload and workflow for the Joint Base Elmendorf-Richardson (JBER) 673d Medical Group. The analyzers shall be capable of performing testing with minimal to no manual preparation of samples by technicians. Automatic repeat testing from the original sample tube is required. The analyzers must be capable of bar code reading and sample level sensing, to include clot detection. The analyzers will accommodate a variety of sample tubes to include primary collection tubes and micro sample tubes. The system will utilize random access sampling to allow for Short Turn-Around Time (STAT) or As Soon As Possible (ASAP) sample loading.

1.2 The analyzers must have the capability of auto verification resulting.

1.3 The analyzers must have an integrated slide maker/stainer plus an attached automated digital cell identification analyzer. The slide maker stainer shall be fully automated, mixing, aspirating and making a wedge type smear – based on patient hematocrit information to optimize the smear such that cells are distributed evenly, labeling and staining the smears.

1.4 The analyzer operating system shall include the capability to track and store, at a minimum, 90 days of calibration, quality control (QC) and patient result data and provide for visual display of graphs and curves for QC data. The analyzer must have the ability to read/write quality control, calibrations, and patient results to Digital Video Recorder (DVR) for peer group correlation/review purposes. The operating system shall interface with the customer’s laboratory information system (LIS) via RS 232C bidirectional interface and accommodate American Standard Code for Information Interchange (ASCII) query capability to process specimen identification and work orders from the LIS. The operating system must meet the USAF cyber security requirements (i.e. Windows, etc.). The fully operational interface (both hardware and software) shall be immediately available for implementation to the MHS Genesis computerized hospital information system.

1.5 The analyzers must meet all necessary power and waste requirements as dictated by the current laboratory workspace.

SECTION 2

GOVERNMENT AND CONTRACTOR FURNISHED PROPERTY AND SUPPLIES

2. The Contractor will provide:

2.1 The 673d Medical Group with two (2) redundant Hematology Analyzers with an integrated slide maker/stainer plus an attached automated digital cell identification analyzer capable of performing on-board standard hematology testing with the following capabilities (to include standard Hematology test panels but not limited to):

2.1.1. Complete Blood Count (CBC), CBC with differentials, Body Fluid counts, reticulocyte panels, nucleated Red Blood Cell (nRBC) measurements, Hemoglobin and Hematocrit (H&H) analysis, and RBC indices calculations.

2.1.2. The analyzer(s) will have the capabilities of: priority run interruptions, STAT 30-minute turnaround time, onboard calibrators and controls which can run automatically at preselected intervals, performing linearity, precision and verification studies, onboard sample aliquots which can be used for reruns and panic repeats without operator intervention, pediatric (micro samples) low volume capabilities, minimum throughput of 100 samples/day and 3300 tests/month.

2.1.3. Instrument must have an integrated slide making-staining unit which function as part of the line where the operator does not have to manually transfer samples and/or rack from the analyzer to the smear preparation unit. Integrated slide maker/stainer must be able to determine via interface which samples require a slide to be prepared and must be capable of labeling the slide with the unique identifier number and date to comply with regulatory requirements.

2.1.4. The integrated cell image analyzer must provide complete automation of the manual WBC differential process allowing a more standardized differential result and extensive network connectivity to enhance the level of service provided to clinicians and patients.

2.1.5. System must provide the ability to connect directly to a digital cell imaging device. This will reduce technologist handling of samples tubes, blood, and slides to diminish errors and exposure to biohazards while improving turn-around times.

2.1.6. The Contractor shall have a quality control program that compares facility data to peers using the same lot and provide a monthly report of such data and include automatic enrollment in a Quality Assurance program that has peer participation. Reports of peer data will be current and available within 2 weeks of the data submission for hard copy review.

2.1.7. The contractor will complete and provide all correlation, precision, linearity, normal range, and any other required validation studies within 60 business days from installation. The information and data must be provided to the Hematology management staff electronically and in a binder.

2.2. The Contractor shall supply all reagents, consumables, calibrators, quality controls, and supplies required when ordered by the Government. The ordered supply level will be based on the needs of the institution.

Calibration intervals will be specifically matched to testing performed by each Government institution.

Orders are placed by the Government on an as-needed basis.

2.2.1. Reagents:

2.2.1.1. All reagents should be “ready-to-use” and require no user performed reagent preparation for any standard testing method.

2.2.1.2. Reagents must have a bar-code identification containing the lot number, expiration date, and unique identification code.

2.2.1.3. Bulk deliveries of reagents shall contain the same lot number for each reagent delivered.

2.2.1.4. If needed all reagent kits must contain all calibrators/quality controls (QC) necessary to calibrate/QC each reagent lot.

2.2.1.5. Reagents and consumables will be shipped to 673

MDSS/SGSL

5955 Zeamer Avenue

JBER, AK 99506

2.3. The Contractor will provide written procedures for Government personnel to perform daily and weekly maintenance procedures that facilitate and maintain routine day-to-day operations.

2.4. The Contractor will provide two hard copies of the manufacturer’s manual(s) for use in the event that the automated management system is non-functional.

2.5. If the analyzer(s) incorporates a water system for operation, the Contractor will provide the de-ionized water supply equipment, hardware, and connection items to support proper operation of the analyzer(s).

2.6. The Government will provide:

2.6.1. An adequate work environment to include proper heat, light, ventilation, and electrical outlets for use by the analyzer(s) and Contractor personnel when servicing the equipment.

2.6.2. A laboratory coat and gloves when the Contractor personnel are working in a potentially infectious area of the laboratory.

SECTION 3

GENERAL INFORMATION

3. Training: The Contractor will provide training of Government personnel as required for proper operation of the analyzer. If training is off-site, airfare, lodging, meals, and local transportation are at the Contractor’s expense. The Contractor shall not be responsible for any negligence of the Government, its officers, agent, servants, and employees who have been adequately trained with regard to any claims, loss, damage, injury and liability resulting from the use of the Contractor’s analyzer. Due to the high turn-over rate of military staff, the Contractor will provide Government personnel training as follows:

673d Medical Group will be allotted 2 training slots per year in the contract base year, then 1 additional training slot per option year executed.

3.1. Service and/or Maintenance Agreement:

3.1.1. The service and/or maintenance agreement shall provide for maintenance of the analyzers in a manner that is equivalent to the industry standard and will ensure optimum operation of the analyzers. This shall include preventive and emergency service. The Contractor shall respond to emergency service calls within one (1) hour by phone, and if required, arrive on-site within 24 hours or at a mutually agreed upon time.

3.1.2. The Contractor shall provide 24/7 telephone access to a troubleshooting service. The Contractor shall perform emergency and scheduled maintenance required for optimum operation of the analyzer.

Routine contractor maintenance will be scheduled and provided during normal business hours; Monday through Friday 0700 AM-1600 PM local time, for the 673d Medical Group.

3.1.3. The Contractor shall coordinate preventive maintenance scheduling through the Government institution as necessary. To schedule call 673d Medical Group Lab Phone at (907) 580-6552. Routine or preventive maintenance will be scheduled during daytime business hours, Monday through Friday, between 0700 AM and 1600 PM Alaska Time. Emergency service can be coordinated outside of normal business hours. No preventive maintenance or consumable deliveries shall be made on Saturdays, Sundays, or federal holidays. If weather conditions exist that prevent a service technician from responding within 24 hours for on-site repairs, Clinical Laboratory staff must be notified within 2 hours of the scheduled time the service technician is to arrive.

3.1.4. If on-site service is required, the Contractor shall arrive on-site within 24-hours from the time of the service call if the analyzer is inoperable; within 48-hours if the analyzer is o p e r a t i n g , but with difficulty;

and within 3 workdays, if the system is exhibiting minor problems which do not inhibit analyzer operation or patient result quality.

3.1.5. The Contractor shall be responsible for cleanup of any and all areas where maintenance has been performed.

3.1.6. The Contractor shall furnish all software upgrades at no additional cost to the Government.

3.1.7. All non-consumable parts and service for the analyzer are the responsibility of the Contractor. Any parts removed or replaced from the equipment shall remain property of the Contractor. After receipt of replacement parts, the Government shall return all defective parts as instructed by the Contractor via surface carrier. Shipping expense of all parts is the responsibility of the Contractor.

3.1.8. The Contractor shall not be responsible for malfunctions as the result of wear and tear due to non-performance of routine operator maintenance and cleaning or external damage caused by the Government to any piece of equipment.

3.1.9. All Contractor employees must check in and check out within the standard operating procedures for each Government institution. Any Contractor visits for maintenance and repairs for the 673d Medical Group analyzers must be coordinated with each the Biomedical Equipment Repair Technician (BMET) office at (907)580-6397. All equipment must be returned to fully operational condition before a laboratory technician accepts the work. The laboratory technician will inspect the work for completion and sign a work order prior to the service repair technician’s departure. Immediately following each preventive maintenance or repair visit, the Contractor’s service technician will submit a written report to the BMET office explaining the repairs and/or maintenance performed.

3.2. Records

3.2.1. In the event of any changes or revision in test methodology, the Contractor shall provide such changes in writing to the Government within five (5) days after publication of changes.

3.2.2. The Contractor shall be responsible for creating, maintaining, and disposing of only those records specifically required by provisions of mandatory directives, specifically but not limited to those identified by the College of American Pathologists (CAP) accreditation guidelines.

3.2.3. If requested by the Government, the Contractor will provide the original record, or a reproducible copy of any such record within two (2) working days of receipt of the request.

3.3. Contractor Personnel

3.3.1. The Contractor shall provide a point of contact (POC) that shall be responsible for the performance of service work on the analyzers. The Contractor shall designate this individual, in writing, and provide contact information to the Government before the contract start date. An alternate POC may be designated, but the Contractor must identify those times when the alternate shall be the primary POC. The Contractor’s POC must be able to read, write, speak, and understand English fluently.

3.3.2. The Contractor shall obtain all necessary licenses and/or permits required to perform his/her work on the analyzer as identified by the analyzer’s manufacturer.

3.3.3. The Contractor shall take all reasonable precaution necessary to protect persons and property from injury or damage during the performance of this contract.

3.3.4. The Contractor shall not employ persons for work on this contract if the employee is identified to the Contractor by the Contracting Officer as a potential threat to the health, safety, security, general well-being or operational mission of the installation and its population.

3.3.5. Contractor personnel shall present a professional appearance and be easily recognized as Contractor employees. Contractor personnel shall abide by all installation traffic laws, rules and regulations.

3.3.6. Contractor employees that perform equipment repairs and preventive maintenance on the analyzer are required to be company trained prior to starting work under the conditions of this agreement.

3.4. Licensing and Certification: The Contractor shall provide evidence of reapplication for any state license, Clinical Laboratory Improvement Amendments (CLIA) certification, or clinical pathology certifications such as those issued by CAP to the Government within 60 days prior to license expiration.

The Contractor shall provide a copy of the renewed licenses or certificates to the Government prior to expiration.

3.5. Security

3.5.1. The Contractor shall ensure all personnel employed in the performance of this contract, or any representative of the Contractor entering the Government installation, abides by all applicable security regulations (AFI 31-204, Air Force Motor Vehicle Traffic Supervision, Chapters 2 & 3).