Attachment 1 Statement of Work (SOW) Hematology Analyzer Reagents dtd 20230202.docx

STATEMENT OF WORK

HEMATOLOGY REAGENTS

1. GENERAL REQUIREMENTS:

1.1. SCOPE OF WORK: The Contractor shall provide Hematology Reagents used in support of Madigan Army Medical Center, Joint Base Lewis McChord, WA. The Contractor shall be responsible for furnishing maintenance, services, repairs, training and parts for a fully automated Complete Blood Counter (CBC) analyzer system and Erythrocyte Sedimentation Rate (ESR) analyzer system (inclusive of instruments and ancillary equipment as required in order to maintain the systems in optimal operating condition, and any installation and removal, at no extra cost to the Government). The Contractor shall perform to the standards of this Statement of Work (SOW).

NOTE: The entire analyzer system will be serviced and supplied through a single Contractor (to whom the contract is awarded), including any parts, equipment, or supplies not manufactured, provided or serviced by the Contractor.

1.2. QUALITY CONTROL (QC) and QUALITY ASSURANCE (QA):

1.2. The Contractor shall provide a Quality Control (QC) Plan that contains, as a minimum, the items listed in 1.2.2 (below) to the Contracting Officer and Contract Officers Representative (COR) for acceptance not later than 10 days AFTER the start of the contract (see Exhibit 1). The Contracting Officer will notify the Contractor of acceptance or required modifications to the plan. The Contractor shall make appropriate modifications and obtain acceptance of the plan by the Contracting Officer.

1.2.1.1. The QC Plan shall include:

1.2.1.1.1. A description of the inspection system to cover all incidental support and maintenance services listed on the Performance Requirements Summary (PRS) listed in Exhibit 1. Description shall include specifics as to the areas to be inspected on both a scheduled and unscheduled basis, frequency of inspections, and the title and organizational placement of the inspectors. Additionally, control procedures for any Government provided keys or lock combinations shall be included.

1.2.1.1.2. A description of the methods to be used for identifying and preventing equipment failure and/or defects.

1.2.1.1.3. A description of the records to be kept to document inspections and corrective or preventive actions taken. NOTE: The records of inspections shall be kept and made available to the Government throughout the contract performance period and for the period after contract completion until final settlement of any claims, if any, under this contract.

1.2.2. Quality Assurance (QA). For those tasks listed on the PRS (Exhibit 1), the COR will follow the methods of surveillance specified in this contract. Government personnel will record surveillance observations, as needed, and provide to the Contractor. The receipt of the observation does not necessarily constitute concurrence with the observation, only acknowledgment that the Contractor has been made aware of the defective performance. Government surveillance may include observations/tasks not listed in the PRS. Such surveillance will be done according to standard inspection procedures or other contract provisions. Any action taken by the Contracting Officer as a result of surveillance will be according to the terms of this contract.

1.2.3. Equipment Troubleshooting. When the Government performs troubleshooting with the Contractor, the Contractor shall replace all reagents, calibrators, controls and any other materials used at no additional cost to the Government IAW Paragraphs 5.4.2.1 and 5.4.2.2. (below).

1,2,4. Performance Evaluation Meetings.

1.2.4.1. The Contracting Officer may require the Contractor to meet with the Contracting Officer and/or COR, as deemed necessary.

1.2.4.2. The Contractor may request a meeting with the Contracting Officer, when the Contractor believes such a meeting is necessary. If required, written minutes of any such meetings shall be recorded in the contract and signed by the Contractor and the Contracting Officer. If the Contractor does not concur with any portion of the minutes, such nonconcurrence shall be provided in writing to the Contracting Officer within 10 calendar days following receipt of the minutes.

1.3. HOURS OF OPERATION:

1.3.1. Normal Hours of Operation. Monday through Friday between the hours of 0730 – 1630 Pacific Standard Time (PST).

1.3.1.1. Holidays. Routine equipment servicing and reagent delivery will not be required on standard Federal Holidays. If an emergency arises, equipment servicing and reagent delivery will be provided in accordance with Section 5.4.3 of this SOW.

1.3.2. The Contractor shall provide equipment maintenance service/direct customer service and support, 24 hours/7 days a week, to include hotline telephone service, and direct connect remote instrument diagnostic capability to assist operators in correcting equipment operation problems.

1.3.3. Legal Holidays. The following legal holidays will be observed by the Government:

New Year’s Day

1 January

Martin Luther King’s Birthday

Third Monday in January

President’s Day

Third Monday in February

Memorial Day

Last Monday in May

Juneteenth

19 June

Independence Day

4 July

Labor Day

First Monday in September

Columbus Day

Second Monday in October

Veteran’s Day

11 November

Thanksgiving Day

Fourth Thursday in November

Christmas Day

25 December

NOTE: Any of the above holidays falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday. Any holidays that are declared by Presidential Executive Order shall be observed in the same manner as the holidays listed above.

1.4. CONSERVATION OF UTILITIES. During maintenance, the Contractor shall make sure employees practice utilities conservation. The Contractor shall be responsible for operating under conditions that prevent the waste of utilities to include:

1.4.1. Lights shall be used only in areas where work is actually being performed.

1.4.2. Employees shall not adjust mechanical equipment controls for heating, ventilation, and air conditioning systems.

1.4.3. Water faucets or valves shall be turned off when not in use.

1.4.4. Environmental and Hazardous Materials Handling. If the disposal of any waste or byproduct of the analyzers cannot be safely dumped into each of the facility’s drain system, the Contractor must provide guidelines for safely disposing these wastes or byproducts in accordance with local and national guidelines.

1.5. RECORDS. The Contractor shall maintain all records necessary to comply with regulatory requirements and Food and Drug Administration (FDA) standards. The Contractor shall be responsible for creating, maintaining, and disposing of only those Government required records that are specifically cited in this SOW or required by the provisions of a mandatory directive listed in section 5.4, Applicable Publications and Forms. If requested by the Government, the Contractor shall provide the original record or a reproducible copy of any such record within 5 working days of receipt of the request.

1.6. REMOVAL OF EQUIPMENT. The Contractor shall not remove any equipment from the Government work site without prior approval of the Department Chief (DC) or his/her designated representative.

1.7. 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 may become 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.

1.8. SPECIAL WORKING CONDITIONS. All equipment, parts, materials, and incidental services supplied by the Contractor shall conform to the applicable Safety and Health Standards as indicated in the current code of federal Regulations, Title 29, Chapter XVII, paragraph 1910, Occupational Safety Health Act of 1970.

1.9. CONTRACTOR PERSONNEL.

1.9.1. Contractor Employees. The Contractor shall not employ persons for work on this contract if such 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 installations and their population.

1.9.1.1. Contractor employees shall present a neat appearance and be easily recognized as Contractor employees. Contractor personnel shall either wear a distinguishable uniform or badge on the exterior of their clothing while performing any service at any Government facility.

1.9.1.2. The Contractor shall not employ any person who is an employee of the US Government. Additionally, the Contractor shall not employ any person who is an employee of the Department of Defense, either military or civilian, unless such person seeks and receives approval according to DOD 5500.7R, “Joint Ethics Regulation”. The Contractor shall not employ any person who is an employee of the Department of Defense, if such employment would be contrary to local policies.

2. DEFINITIONS/ACRONYMS.

2.1. DEFINITIONS. Following is a list of basic definitions. .

2.1.1. CONTRACTING OFFICER: The ONLY person with the authority to enter into, administer, change, and/or terminate contracts and make related determinations and findings.

2.1.2. CONTRACTING OFFICER'S REPRESENTATIVE (COR): This may also include a designated Point of Contact (POC). A Government employee selected and designated in writing by the Contracting Officer to act as his/her designated representative in administering a contract. NOTE: The COR is not authorized to make any changes to the terms and conditions of the contract.

2.1.3. QUALITY ASSESSMENT AND IMPROVEMENT. Those actions taken by the Government to check services to determine if they meet the requirements of the CLIA/DoD CLIP ’88 & ’03, CAP, JCAHO, U.S. Army Medical Command and U.S. Navy Bureau of Medicine quality assurance and risk management programs, and ensure compliance with the terms and conditions of the contract

2.1.4. QUALITY CONTROL. Those actions taken by a Contractor to control the performance of services to ensure that they meet the requirements of the contract.

2.1.5. SERVICES: Includes incidental maintenance services and support performed and materials furnished or utilized to maintain the equipment.

2.1.6. QUALITY IMPROVEMENT (QI): Those actions taken by the Government, in accordance with MAMC DPALS Quality Plan, relevant CSLI standards for quality, AR 40-68, to assure services meet the requirements of the SOW.

2.2. ACRONYMS/ABBREVIATIONS. Following is a list of basic acronyms/abbreviations used in the contract.

AR

Army Regulation

BUMED

U.S. Navy Bureau of Medicine and Surgery

CAP

College of American Pathologists

COR

Contracting Officer's Representative

DA

Department of the Army

DN

Department of the Navy

DoD CLIP

Department of Defense Clinical Laboratory Improvement Program

HIPAA

Health Insurance Portability & Accountability Act of 1996

MAS

Minimum Acceptable Standards

MEDCOM

U.S. Army Medical Command

JC

Joint Commission

OSHA

Occupational Safety and Health Administration

PMS

Preventive Maintenance Services

PRS

Performance Requirements Summary

POC

Point of Contact (See Contracting Officer’s Representative defined above)

QA&I

Quality Assessment & Improvement

QC

Quality Control

SOW

Statement of Work

3. GOVERNMENTFURNISHED FACILITIES, EQUIPMENT, MATERIAL, AND SERVICES. The Government will provide, without additional cost to the Contractor, the facilities, equipment, materials, and services listed below.

3.1. FACILITIES. The Government will furnish the facilities for set-up and operation of the Contractor equipment analyzers required in support the SOW. The Contractor shall not alter the facilities without written approval of the Contracting Officer. The Contractor shall return the facilities to the Government in the same condition as received, fair wear and tear and approved modifications excepted. These facilities shall be used for performance of this contract only.

3.2. EQUIPMENT. No equipment will be provided.

3.3. MATERIALS. No materials will be provided.

3.4. SERVICES. The Government will provide the following services at no cost to the Contractor:

3.4.1. The Government will provide the normal range of facility utilities (e.g. electricity, water, heating, refuse collection, etc.) and other utilities necessary for the full functionality of the equipment/instrumentation.

3.4.2. Security: Police and Fire Protection, as is provided other personnel.

3.4.3. Emergency Healthcare for Contractor employees. The MTF will provide emergency health care for injuries or life threatening medical emergencies occurring while on duty. The Contractor shall reimburse the Government for such services as billed by the MTF, unless the Contractor employee is otherwise authorized to receive such services at no cost (e.g., is retired military or is a military dependent).

4. CONTRACTOR FURNISHED PROPERTY

4.1. General. Except for those Government-furnished items and services specified in section 3, the Contractor shall furnish all items, equipment, and incidental support and maintenance services required under this contract.

4.2. Transportation. Transportation in support of any equipment and incidental support and maintenance services is the responsibility of the Contractor. The Government will not provide transportation.

4.3. Nametags. The Contractor shall furnish a nametag for each contract employee. The nametag will contain the name of the company and the employee.

5. SPECIFIC TASKS

5.1. DESCRIPTION

5.1.1. The Contractor shall support a FDA approved, fully automated, scalable, discrete random access hematology analyzer capable of providing a complete blood count (CBC), body fluid counts with two part differential, erythrocyte sedimentation rate (ESR) analyzer and all of the required assays as listed in Table 1. The entire analyzer system will be serviced and supported through a single Contractor (to whom the contract is awarded), including any parts, equipment, or supplies not manufactured, provided or serviced by the Contractor. The system, as defined in 5.1.1.1 shall provide redundancy (to ensure continuous operations). The Contractor shall provide support for the system, training, supplies, reagents, unscheduled maintenance, and preventive maintenance for the system. All equipment displays and supporting literature must be in the English language. If new equipment is required, the contractor shall include delivery, installation, all calibrators/standards, reagents/reagent packs, and quality control materials necessary to perform the specified assays, initial Method Validations per the Clinical Laboratory Standards Institute (CLSI) guidelines and the DPALS Quality Manual (QM). The Contractor will also provide analyzer removal at the termination of the contract. All costs will be calculated on a cost per patient reportable or patient billable basis based on the number of patients listed for each Mandatory Test listed on Appendix 1. Costs shall be amortized over the total number of tests described in this SOW and factored into the cost per reportable or patient billable.

Table 1.

5.1.1.1. For the purposes of this SOW the analyzer system includes at a minimum:

- Any and all analyzers

- Peripherals (e.g. Uninterruptable Power Sources (UPS), instrument specific computer terminals and CPUs, etc.)

- Robotics/Automation System (“walk-away” automation is preferred) to include Automated Pre-analytical Processing System (e.g. Automated Slide Maker, Automated Slide Stainer etc.)

- Integrated automated digital cell morphology analyzer.

- Pedestal (floor stand) capable of supporting the complete analyzer system.

5.1.1.2. The analyzer system will be located at:

Madigan Army Medical Center 9040A Fitzsimmons Drive Tacoma, WA 98431

5.1.2. 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 if necessary.

5.1.3. If necessary, Method Validation will be conducted in accordance with method validation protocols established by the Department of Pathology’s Quality Management Program (these protocols are in concordance with applicable standards as described by the Clinical Laboratory Standards Institute (CLSI) and/or required by the College of American Pathologists (CAP)). Relevant guidelines listed in Appendix 2 (below) are the minimum guidelines that will be referenced when conducting method validation. Additional guidelines may be required, depending on regulatory requirements.

5.1.3.1. If necessary, Method Validation will include but not be limited to, normal range verification, demonstration of linearity, reportable range, correlation with current methods (comparison of methods study), validation of precision (replication study) and accuracy (recovery study), and establishment of initial control ranges using control materials, to include third party controls, as designated by the Laboratory Director.

5.1.3.1.1. If necessary, The Method Validation will be completed and approved by the Laboratory Director prior to reporting of patient results. Payment for services will not begin until the analyzer system has been approved for reporting of patient results.

5.1.3.2. The Contractor shall provide a qualified Technical Service Representative, who possesses a thorough knowledge of method validation and is familiar with the use of statistical evaluation software EP Evaluator®, to provide technical assistance for the method validation studies. The assigned Technical Service Representative will be responsible for the entire Method Validation.

5.1.3.3. All reagents, calibrators and linearity materials used in the Method Validation Study will be provided by the Contractor at no additional cost to the Government. These materials will not be used in the analysis of specimens for patient care.

5.1.3.4. The Government’s Technical Supervisor will obtain patient specimens for use in the Method Validation. In the event that specimen requirements for correlation studies cannot be met (e.g., insufficient number of patients to challenge the extremes of a curve), the Contractor shall assist in procuring additional specimens. These specimens may be obtained from other laboratories or from Contractor sources.

5.1.3.5. Both the Contractor and Contractor personnel at each location shall abide by all Health Insurance Portability & Accountability Act of 1996 (HIPAA) rules and regulations when conducting the Method Validation Study.

5.1.4. The Contractor shall provide two (2) paper and a PDF copy of the Operator’s and Maintenance manuals and a statement of the warranty terms in the English language. The level of detail required of appropriate instrument maintenance manuals extends only to routine maintenance procedures performed by the user. All instrumentation specified is non-Government owned leased equipment that is serviced and maintained by the Contractor.

5.1.5. The Contractor shall provide safety data sheets (SDS) for each item delivered under this contract that is considered to be HAZARDOUS MATERIAL by the United States or the Contractor’s representative Government. The SDS shall contain information on the hazards associated with each specific chemical or material. The SDS shall be printed in the English language and shall contain, as a minimum, identification of:

- The hazardous material

- The specific hazard

- The required practices for the safe use of the product

- First aid procedures

- What to do in the event of a spill or other mishap or accident.

- Information about carcinogens as per CAP requirements

5.1.6. The Contractor shall provide a water system (e.g. filtered, deionized etc.), if required by the analyzer, that shall provide uninterrupted service for a period of time to be determined by the Laboratory Director.

5.1.7. The Contractor shall provide the reagents and shall coordinate exact quantities and shipment schedule with the COR prior to shipment IAW Paragraph 5.3.14, Deliveries (below).

5.1.8. The Contractor shall be responsible for the collection and transportation of equipment upon termination of the contract.

5.2. ANALYZERS.

5.2.1. Individual analyzers shall have fully automated, discrete random-access capabilities within the same instrument.

5.2.1.1. There shall (must) be able to connect to the current Roche chemistry automation line to provide a single point of specimen entry for the routine analysis of all required tests and move specimens bi-directionally. There shall (must) be an optional ability to directly load specimens onto the analyzer for priority analysis of STAT specimens or during times the automation line is unavailable.

5.2.2. The instruments provided will be capable of the following:

5.2.2.1. The system will come equipped to perform continuous, random and statistical analysis; capable of real time or (on-line) Quality Control. Provide QC assessment with comparison to a peer group on a daily, weekly, and monthly basis, to include QC Lot#s, means, ranges, SD, and CVs%. Changing or modifying existing QC parameters can be performed during instrument operation (e.g. “on-the-fly”).

5.2.2.2. Six Part Differential that includes neutrophils, lymphocytes, monocytes, eosinophils and basophils, and immature granulocytes cell-by-cell analyses; reportable range from 0 to 300 Thousand cells/uL and indicators of white cell viability; in absolute and percentage numbers. With accuracy and precision listed in Table 2. The accuracy of the automated differential as compared to manual differentials will be no less than the accuracy of the current system.

Table 2

5.2.2.3. Specimen analysis will provide a technology with demonstrated performance that corrects for interfering substances, such as: NRBCs, platelet aggregation, cold agglutinins, fragmented RBC's, extreme sickle cell, ABN RBC fragility, spherocytosis, leukocytosis (>100,000/µL), bilirubin > 30 mg/dL, and lyse resistant RBC's.

5.2.2.4. Sample size is less than 200 µL (preferred = 175 µL) in all modes with a maximum dead volume of 500 µL.

5.2.2.5. The analyzer system will have an interface that is compatible to the government system Cerner Millennium. The analyzer will be able to recognize a variety of generated bar-code labels (code 128) on primary sample tubes.

5.2.2.6. Hemoglobin will be determined by direct spectrophotometric analysis.

5.2.2.7. Provide for the direct measure of individual leukocyte population (vs. calculated parameters) and will analyze leukocytes in their near-native state so as not to physically or biochemically alter their morphology.

5.2.2.8. Routine “hands-on” maintenance will be minimized; no “hands-on” maintenance is preferred.

5.2.2.9. Provides surface plots to review WBC differential populations, NRBC and Retic populations.

5.2.2.10. Prepares microscope slides automatically or flags problems for slide prep.

5.2.2.11. Capable of performing automatic NRBC differential and automatic correction of the white blood cell count, and capable of enumerating Nucleated Red Blood Cells (NRBCs) accurately.

5.2.2.12. Capable of performing digital cell morphology in an automated fashion and integrated in the analyzer system.

5.2.2.13. Capable of performing automated cell counts on body fluids (CSF, synovial, pleural and peritoneal) to include white blood cell linearity to a minimum of 5 and red blood cell linearity to a minimum of 500 cells counted. Must (shall) provide at least a two part differential for neutrophil and lymphocyte.

5.2.3. The analyzer system shall provide users with rapid, reliable test results that are critical for patient care.

5.2.4. Minimum actual through-put shall be 125 whole blood counts per hour, and 50 reticulocyte counts per hour with both open mode (manual sampling) and closed mode sampling to include micro sampling for “pedi-tubes” and MAP tubes used for NICU patients.

5.2.5. All analyzer/data management system displays and supporting literature shall be in the English language.

5.2.6. Initial startup from the shutdown state shall (must) not exceed 20 minutes.

5.2.7. Each analyzer system shall (must) come equipped with an un-interruptible power supply (UPS) capable of providing all necessary electrical power to each analyzer system, to include the data management system for 15 to 20 minutes.

5.2.8. The analyzer systems and all reagents shall be approved by the Food & Drug Administration (FDA). All analyzers and associated parts and accessories shall be new. No used, refurbished, or like-new equipment shall be provided in support of this contract at any time.

5.2.9. Capable of handling 75mm X 13mm or 100mm X 13mm standard or Hemaguard (or equivalent) test tubes in the open or closed mode in a single cassette.

5.2.10. Has FDA Clearance on Body Fluids for serous (including pleural, peritoneal and pericardial), synovial (pretreated with hyaluronidase), and cerebrospinal fluid (CSF).

5.2.11. Platelet count by size, impedance, and/or alternate method, auto-verification of results at critical ranges and reportable range from 0 to 3 million cells/uL. Mean platelet volume (MPV). Capable of determining platelet clumping, enlarged platelets, and can differentiate between a large platelet and small red blood cell minimizing the need for a manual differential to confirm.

5.2.12. The analyzer system must be capable to be seismically mounted or secured to the floor to mitigate any damage or harm to humans in the event an earthquake occurs.

5.2.13. The analyzer system must be capable of separating blast cells, abnormal lymphocytes, and normal mature lymphocytes.

5.3. REAGENTS.

5.3.1. The analyzer shall (must) have the on-board ability to maintain reagents at the proper storage temperatures for the assays listed in Appendix 1.

5.3.1.1. The workload listed in Appendix 1 is an estimate based on projected patient workload. Actual workload may vary. The workload numbers represent patient reportable results, and do not include calibrators, controls, or re-runs due troubleshooting.

5.3.1.1.1. The actual workload may fluctuate in the first year of the contract due to changes in the distribution of patient care. In addition, workload may expand in subsequent option years due to fluctuations in patient volume, and with the inclusion of other locations. Appendix 1 provides the estimated workload for Contract Year 1 as well as an estimated workload for each option year. All workload numbers represent total estimated patient reportable/billable results for the indicated year.

5.3.1.1.2. To account for expected fluctuations in workload, the Contractor shall provide a “volume discount” based on exceeding the planned patient load each period of performance. As workload increases, the cost per reportable patient result should decrease. The workload shall be based on the total number of patient reportable results covered under the provisions of this SOW.

5.3.2. The Contractor shall 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 Appendix 1.

5.3.2.1. The Contractor shall provide quality control materials IAW requirements outlined in the Laboratory QA program and approved by the Laboratory Director. This includes third-party controls where requested/required by the laboratory.

5.3.2.2. The Contractor shall ensure that requirements for routine quality control runs (as defined by the Laboratory Director and outlined in the Laboratory QA program), routine calibration, periodic calibration/calibration verification (i.e., each assay must be calibrated or have calibration verification performed at intervals not to exceed a 6-month period of time), and for troubleshooting of out-of-control assays be considered when calculating the yearly requirements.

5.3.2.3. The Contractor shall 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, at the level of use specified in Appendix 1. An operator level maintenance tool/spare parts kit will be provided and replenishment of all expended items will be made by the contractor, at no additional cost to the Government. Replenishment shall be made as needed or on a periodic basis not to exceed the normal preventive maintenance cycle.

5.3.3. Reagents shall (must) have a minimum shelf life of three (3) months, and controls will have a minimum shelf life of four (4) weeks upon receipt by the Government. If this shelf life requirement cannot be met, the Contractor shall (must) identify the guaranteed shelf life after receipt that can be accommodated in their response to the Request for Proposal/Request for Quote.

5.3.3.1. Reagents needed to operate the instrument on a monthly basis must fit in a 3’ x 2’ x 3’ (L x W x H) space.

5.3.4. The Contractor shall sequester the required quality control materials and test reagents to ensure no more than one lot change per contract year (preferably can remain on the same lot for the entire year).

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

5.3.5.1. Be provided by the manufacturer of the equipment.

5.3.5.2. Be marked with the required storage temperature.

5.3.5.3. Inclusive of an English language package inserts.

5.3.5.4. If the bulk reagents are produced overseas, they will be manufactured in conformance with ISO or CE standards AND must be equal to or better than the U.S. products in quality/manufacturing. Documentation of item equivalency must be provided.

5.3.5.5. 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.

5.3.6. The Contractor shall provide the reagents/reagents packs, calibrators/standards, quality control materials, user-replaceable maintenance items, and analyzer specific tools/supplies as outlined in the Schedule of Supplies/Services.

5.3.7. Deliveries. Deliveries of required items shall be per monthly or quarterly standing orders. Any supplies that are placed on back order shall be clearly identified on the shipping documents and shall be delivered in a timely manner, not to exceed ten (10) working days. In the instance a backorder exceeds 10 working days, the Contractor shall provide testing services through local sub-contract at their cost.

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

5.3.7.2. Emergency orders shall be delivered within 24 hours after the order is placed and be of the same lot number of calibrators/standards, reagents/reagent packs, or quality control materials currently in use for the assay(s) for which supplies are being requested.

5.3.8. Preservation and packing - Preservation and packing shall be performed in accordance with the best commercial practice and in such a manner to afford adequate protection against any 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 deliveries will be made Tuesday through Thursday, to exclude Federal Holidays.

5.4. ANCILLARY MAINTENANCE AND SERVICE

5.4.1. ANCILLARY MAINTENANCE. The Contractor shall be responsible for furnishing maintenance, services, repairs, and parts as required in order to maintain the systems in optimal operating condition.

5.4.1.1. The Contractor shall maintain all equipment installed under this contract except for repairs necessitated by willful damage or negligence on the part of the Government.

5.4.1.2. The Contractor shall 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 shall 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 determination of time frames for performance of the above periodic services.

5.4.1.3. The Contractor shall provide a full unscheduled and preventive maintenance service for the lease period at no additional cost. Service shall include repair and replacement of defective parts, complete maintenance program (as required by the manufacturer’s maintenance manuals), and hotline telephone service, to assist operators in troubleshooting problems in accordance with paragraph 5.4.3.1. of this SOW.

5.4.2. REPAIR. Upon notification of equipment failure, the Contractor’s qualified service technician shall establish telephonic contact within 60 minutes of the Government notification to the Contractors Customer Service “Hotline” and shall be on-site to provide unlimited emergency service (service requiring immediate repair) within four (4) hours of establishing telephonic contact. The equipment shall be repaired and operational within 48 hours after initial response by the Contractor. Should both instruments become inoperable, the Contractor’s technical specialist must be on-site within four (4) hours of initial notification. If the equipment cannot be repaired, a replacement instrument shall be provided within 72 hours. The Contractor shall provide replacement parts as necessary for operator level maintenance.

5.4.2.1. The Contractor shall provide all reagents, calibrators, controls and any other materials necessary to troubleshoot the reasons for the analyzer failure at no additional cost.

5.4.2.2. The Contractor shall replace all reagents, calibrators, controls and any other materials used by the Government to trouble shoot the instrument failure prior to notification of the contractor.

5.4.2.3. 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 shall be required to correct the deficiency to a fully operational status in accordance with manufacturer specifications at no additional cost to the Government.

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

5.4.2.4. 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, 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.

5.4.2.4.1. The Contractor shall notify the COR or ACOR of the exact date and time for performance of a preventive maintenance service within ten (10) days prior to the scheduled preventive maintenance services.

5.4.2.5. The use of two-way radios, as well as smoking, is prohibited within Madigan Army Medical Center and its clinics.

5.4.2.6. Prior to performing Scheduled Maintenance and Unscheduled Repair Services work, the Contractor's representative shall report to and obtain from the Equipment Management Branch, at the MTF a Visitors Badge. The badge must be returned to the Equipment Management Branch prior to departing the MTF.

5.4.2.7. 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 (i.e., preventive maintenance service, or unscheduled repair service)

· Location of services performed

· Duration of performance (hours)

· List of parts replaced or other actions taken to restore operability of the instrument

· Name of technician

5.4.2.8. The Government will and the Contractor shall exchange hazard communication information before the commencement of any repair.

5.4.2.9. When required, the Contractor shall comply with the Occupational Safety and Health Administration lockout and tagout procedures while performing maintenance on electrical equipment.

5.4.2.10. Safety Inspections shall be performed at least annually in accordance with NFPA 99, Chapter 7. This regulation can be reviewed in full text at the Equipment Management Branch.

5.4.2.11. Preventive maintenance inspections and calibrations shall (must) be performed in accordance with Contractor’s guidance as specified in the Contractor’s instrument maintenance manual.

5.4.2.13. When appropriate, the Contractor’s representative shall attach and complete a DD Form 2163 (sticker), entitled “Medical Equipment Verification/Certification” to the equipment upon completion of calibration services. The COR shall provide the DD Form 2163 to the Contractors’ representative. If the DD Form 2163 is already attached to the equipment, the Contractors' representative shall update the existing DD Form 2163. Procedures for updating the 2163 will be provided by the COR.

5.4.3. SERVICE:

5.4.3.1. The Contractor shall provide direct customer service 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 problems.

5.4.3.2. The Contractor shall perform Preventive Maintenance Services (PMS), safety tests, calibrations, and unscheduled repair services in accordance with procedures and practices prescribed by the manufacturer of the equipment.

5.4.3.3. The Contractor shall provide a full unscheduled and PMS throughout the contract. PMS shall be at no additional cost to the Government 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 analyzer system, including replacement parts, replacement part shipment costs, and service technician travel costs for performance of maintenance services.

5.4.3.4. Scheduled routine services shall be performed between 0730-1630 Monday-Friday, excluding Federal Holidays.

5.4.3.5. The Contractor’s qualified service technician shall be on site to provide routine services; service requiring immediate repair; and one (1), two (2) or four (4) scheduled services for preventive maintenance (as specified in the Contractor’s instrument maintenance manual), safety and calibration as required by this statement of work. The equipment shall be repaired and operational within 48 hours after initial response by the Contractor.

5.4.3.6. Upon analyzer or ancillary equipment failure (slide maker/stainer, computer, UPS, etc.) failure, the Contractor’s qualified service technician shall be on-site to provide unlimited emergency service (service requiring immediate repair; an unscheduled maintenance/service requirement). The Contractor’s qualified service technician shall establish telephonic contact within 60 minutes of the Government notification to the Contractors Customer Service “Hotline” and shall be on-site to provide unlimited emergency service (service requiring immediate repair) within four (4) hours of establishing telephonic contact. The equipment shall be repaired and operational within 48 hours after initial response by the Contractor.

5.4.3.6.1. The Contractor shall provide all reagents, calibrators, controls and any other materials necessary to troubleshoot the reasons for the analyzer failure at no additional cost.

5.4.3.6.2. The Contractor shall replace all reagents, calibrators, controls and any other materials used by the Government to trouble shoot the instrument failure prior to notification of the Contractor.

5.4.3.6.3. The Contractor’s qualified service technician shall ensure all repairs are completed and the analyzer is fully operational prior to departing the lab. In addition 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.

5.4.3.7. Emergency Services and unscheduled services outside regular working hours, on weekends, and on Federal Holidays shall be listed as a separate line item. These services shall be conducted in the same manner as all other emergency services as described in 5.4.3.6. Estimated emergency visits per year are six (6).

5.4.3.8. Should both analyzers become inoperable, the technical repair specialist shall be on-site as described in 5.4.3.6.

5.4.3.8.1. The Contractor’s qualified service technician shall be on-site to provide unlimited emergency service as described in 5.4.3.6.

5.4.3.8.2. 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 arrange the pickup and delivery of critical specimens to a College of American Pathologists accredited clinical laboratory.

5.4.3.8.3. During any period when both analyzers are inoperable, the Contractor shall pay all costs associated with the provision of alternative testing, including those for delivery of hardcopy patient results by express courier, directly to the laboratory, for as long as both analyzers remain inoperable.

5.4.3.8.4. Hardcopy patient results shall provide all information as required in the Laboratory QA Plan and approved by the Laboratory Director. This information shall include, but not be limited to positive patient identification, laboratory results and the testing laboratory’s reference range for the test being performed.

5.4.3.9. If the equipment is out of service for longer than 48 hours (from the time of service technician’s arrival on site), the Contractor shall notify the Chief, Clinical Engineering Branch and the COR in writing as to the reason(s) (i.e., non-availability of parts, etc.) for non-compliance.

5.4.3.10. The Contractor shall provide all necessary user-replaceable maintenance items required to support the analyzer and any analyzer specific tools/supplies necessary to perform operator-level periodic maintenance tasks, at no additional cost to the Government.

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

5.5. TRAINING:

5.5.1. The Contractor shall provide initial on-site operator training to all technicians assigned to the Government site (i.e., MAMC Dept of Pathology Laboratory staff) prior to initiation of use of the analyzer for patient testing. In addition, the Contractor shall provide training for two (2) primary operators, per analyzer at the Contractor’s training site, prior to delivery and installation of the analyzer.

5.5.1.1 The on-site operator training shall be provided by qualified Contractor trained personnel using Contractor-owned instrumentation in a mobile environment. The training shall encompass basic operation, maintenance and troubleshooting.

5.5.2. The Contractor shall provide two training slots per analyzer per contract year, at the Contractor’s training site, at no additional cost (including transportation airfare, rental car, per diem, etc.) to the Government. The Contractor may charge the Government only for training services exceeding the basic requirement for a given contract year.

5.5.3. The Contractor shall provide on-site training for 8 technicians annually at no additional cost to the Government or individual trainee.

5.5.3.1 The on-site operator training shall be provided by qualified Contractor-trained personnel using Contractor-owned instrumentation in a mobile environment. The training shall encompass basic operation, maintenance and advanced troubleshooting.

5.5.4. All training manuals/guides, instructional literature, and any other related written/electronic material shall be in the English language. Training shall include basic operation of the analyzers, trouble shooting procedures, performance of operator-level periodic preventive maintenance procedures, and use of the data management/quality control software.

5.6. INFORMATION MANAGEMENT.

5.6.1. The analyzer system shall (must) be capable of interfacing with the military hospital computer system, i.e., the Cerner Millennium. The Contractor shall (must) have an established driver compatible for interfacing the analyzer with the Cerner Millennium. The interface between Cerner Millennium and the analyzer shall (must) be bi-directional.

5.6.2. The analyzer system shall (must) include a data management system for control of the operation of the analyzer system, management of the quality control program, management of the on-instrument useful life of the reagents/reagent packs, and management of patient results; and a printer for the production of hard copy patient reports and other reports generated via the analyzer system’s data management system. The Data Management system shall have a comprehensive, fully-integrated Quality Control (QC) software module that stores and evaluates quality control results. Results can be viewed in a variety of formats including Levy-Jennings charts, moving patient averages, and statistical summaries. The application shall validate QC results by checking them against user selected rules and automatically alert the operator when a rule violation has occurred.

5.6.2.1. The QC software shall have a large capacity to store graphics and results, cumulative patient reports and quality control files with statistics - all available to user.

5.6.2.2. The QC software shall provide the capability to write user defined Westgard QC Rules. In addition it shall integrate with the result manager for auto verification of results, allow viewing and maintaining of QC data across multiple levels and lots for connected analyzers, provide a mechanism to maintain an action log of comments from QC review, provide real-time access to QC charts, graphs (Levy-Jennings) and provide the ability to add comments, and eliminate data point(s) from statistics. The QC software shall (must) include the ability to apply Westgard quality control result decision rules in real-time, with the ability of the user to individually select the rules to be applied.

5.6.3. Data Management system shall (must) have a user friendly "Windows Based" interface that shall include a data management system for operational control of the analyzer system, management of the QC program, on-instrument useful life of the reagents/reagent packs, and management of patient results.

5.6.3.1. The software shall provide a single operator interface for workload management, data management, and instrument operational status monitoring. The software controls the operations of the analyzer, monitors the lot number expiration date of on-board reagents and control materials. This shall be accomplished via communication connections between the automation, analyzers, and hospital Laboratory Information System (LIS).

5.6.3.2. The results management application shall manage patient data, sample and QC results by offering archiving, status, calculation of results and long-term results storage of at least a years’ worth of patient results.

5.6.3.3 The software shall provide proactive monitoring of key instrument parameters to allow for predictive diagnostics.

5.6.3.4. The Data Management system shall (must) use Microsoft Windows 10 that includes the most current version with all the security updates.

5.6.4. The Contractor shall provide a Thin Client-type data management system that allows for remote operational control of the analyzer system, management of the quality control program, on-instrument useful life of the reagents/reagent packs, and management of patient results.

5.6.4.1. The Thin Client shall provide a dynamic display sample status, allow for dynamic/real-time review and management of the quality control program, review of on-instrument useful life of the reagents/reagent packs, and management of patient results instrument. In addition, the status of automation components and communications shall be able to be monitored from a single remote interface.

5.6.4.2. The Thin Client shall provide a dynamic interface with other analyzers that are not physically attached to the automation line. These analyzers may, or may not be from the same vendor.