INTENT TO SOLE SOURCE Attachment SOW-Salient Characteristics (W81K0225QA082).pdf

Continuation of Description

STATEMENT OF WORK CHEMISTRY IMMUNOASSAY REAGENTS

1. GENERAL REQUIREMENTS:

1.1. SCOPE OF WORK: The Contractor shall provide continued support of Roche Total Laboratory Automation line and 3 Cobas Pro lines for Madigan Army Medical Center (MAMC), Joint Base Lewis McChord, WA (inclusive of instruments, ancillary equipment, maintenance, services, repairs, support, and parts as required in order to maintain the systems in optimal operating condition, and any installation and removal). The Contractor shall perform to the standards of this Statement of Work (SOW). Contractor will only need to enter JBLM to troubleshoot or perform maintenance of analyzer. Supplies may be delivered via third party (FEDEX or UPS).

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

1.2.1. The Contractor shall provide a Quality Control (QC) Plan that contains, as a minimum, the items listed in 1.2.1.1 (below) to the Contracting Officer and Contract Officers Representative (COR) for acceptance not later than 21 calendar 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.

1.2.4.3. During the installation and validation of the equipment and tests to be performed, the Contractor will schedule meetings with technical experts of the Laboratory to discuss milestones and to provide updates on completion date. Following the completion of the installation of the new equipment and validation of the tests to be performed, the Contractor will meet with technical experts from the Laboratory at times mutually agreeable to discuss areas of interest to the Laboratory or hospital staff.

1.2.4.3.1. The Contractor shall provide at no additional cost to the Government the ability to request visits from medical and/or scientific advisors /specialists to discuss with the Laboratory and/or hospital staff areas of interest, to include but not limited to, new tests of interest, application of current tests in specific specialty areas (e.g., Cardiology, Endocrinology, Nephrology, etc.), etc.

1.3. HOURS OF OPERATION:

1.3.1. Normal Hours of Operation. Monday through Friday between the hours of 0730 - 1630 Pacific time.

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. Federal Holidays. The following Federal 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 if the above Federal holidays fall on a Saturday, the holiday 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 addition to and 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 COR or his/her designated representative.

1.7. UPGRADE OF EQUIPMENT. Subject to mutual agreement between the Government and the Contractor, equipment/instrumentation may be upgraded within the specifications of the contract as new technology may become available or if workload exceeds the equipment's/instrument's current capacity. Additionally, the Government will delete/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.

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): 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, and Defense Health Agency 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.

2.1.7. 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 DHA- Defense Health Agency

JC - Joint Commission

OSHA - Occupational Safety and Health Administration PMS Preventive Maintenance Services

PRS Performance Requirements Summary

QA - Quality Assurance

QA&I - Quality Assessment & Improvement

QC - Quality Control

SOW - Statement of Work

3. GOVERNMENT-FURNISHED 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.

SPECIFIC TASKS

5.1. DESCRIPTION

5.1.1. The Contractor shall provide a fully automated system that includes: discrete random access chemistry/immunochemistry analyzer system capable of performing all of the required assays listed in Appendix 1, pre-analytical processing and sorting, post-analytical storage, and the ability to connect to hematology, coagulation, urinalysis, and additional testing platforms (See paragraph 5.2 below). The chemistry/immunochemistry analyzer system will be from a single Contractor. For certain specific esoteric tests (e.g., drugs of abuse, methotrexate, Glucose-6-phosphate Dehydrogenase (G6PD), etc.), the Contractor may subcontract for the specific reagents, calibrators and controls, but not instrumentation. The system shall provide redundancy (to ensure continuous operations), training, supplies, reagents, unscheduled maintenance, and preventive maintenance for the equipment.

All equipment displays and supporting literature must be in the English language. 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 CLIA /NCCLS/DPALS QM guidelines and 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 Tests or Optional Tests listed on Appendix 1. Costs shall be amortized over the total number of tests described in this SOW and factored into the cost per patient reportable or patient billable.

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

- Any and all analyzers

- Peripherals (e.g. instrument specific computer terminals and CPUs, printers, etc.)

- Uninterruptable Power Sources (UPS)

- Water purification system

- Robotic Automation Systems

- Automated Pre-analytical Processing Systems

- Automated Post-analytical systems

5.1.1.2. The analyzer systems 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. Additionally, the installation of equipment may need to be performed in a phase process at no additional cost to the government.

5.1.3. Method Validation will be conducted entirely by the Contractor 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. Method Validation will include but not be limited to, reference range verification, demonstration of linearity with limit of quantitation verification (LOQ), limit of detection verification (LOD), reportable range, correlation with current methods (comparison of methods study), validation of analytical measurement range (AMR), validation of clinical reportable range (CRR), validation of imprecision (within day and between day) and accuracy (recovery study), plasma/serum correlation studies, 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. The Method Validation will be completed and approved by the Laboratory Director prior to reporting of patient results. Payment 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 EP Evaluator(r) as a statistical evaluation software 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, to include third party reagents and controls as indicate by the Government and agreed upon by the Contractor. These materials will not be used in the analysis of specimens for patient care. When new tests or new Generations of reagents are available/added, the Contractor will perform all necessary validation studies and supply all necessary reagents, calibrators, linearity materials.

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 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 an electronic 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.

5.1.4.1. User daily required maintenance shall not exceed 20 minutes per analyzer.

5.1.5. The Contractor shall provide electronic copies of all safety data sheets (SDS) for each item delivered under this contract that is considered to be HAZARDOUS MATERIAL by the United States. 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.

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.

The water system needs to be self-contained, require minimal maintenance, and have the smallest space requirements as is possible. The Contractor will be responsible for all maintenance and parts for the water system provided by the Contractor.

5.1.7. The Contractor shall provide the reagents and shall coordinate 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.

5.1.9. At the execution of every option year, the contractor will perform a business review that encompasses every tested analyte to ensure proper pricing is applied.

5.2. AUTOMATION LINE - The contractor will support (to include instruments, ancillary equipment, maintenance, services, repairs, support, and parts as required in order to maintain the systems in optimal operating condition, and any installation and removal) the automation line in use at

MAMC.

5.2.1 The Contractor shall (must) update the automation line with current components available regardless if the current components are customer options or mandatory per the contractor.

5.2.1.1 Automation line must include, at a minimum, 3 centrifuges, specimen integrity, aliquotter, barcode marker, temporary storage, and an output unit.

5.2.1.2 Automation line must be bidirectional and able to connect to Sysmex hematology analyzers and Diagnostica Stago analyzers.

5.2.1.3 Must be able to purchase entire automation line and post analytical unit for the sum of 1 dollar to be exercised immediately upon award.

5.2.2 CHEMISTRY AND IMMUNOCHEMISTRY ANALYZERS - The contractor shall (must) provide individual analyzers that are fully automated, have discrete random access capabilities for chemistry, immunometric, potentiometric, and colorometric assays within the same instrument, i.e. not separate chemistry, immunometric, potentiometric, and colorometric analyzers.

5.2.2.1. The total number of analyzers shall be determined by the minimum throughput, available menu requirements, patient acuity and be able to continually operate for 12-hrs without having to stop to load reagents or consumables. Consumables shall (must) be able to be loaded without taking the analyzer off line, i.e. stopping the analyzer or placing the analyzer in a paused state.

5.2.2.2. Minimum actual through-put shall: 500 tests per hour for immunometric assays, 1600 tests per hour for enzymatic/rate and colorimetric /photometric assays and 2000 tests per hour for ISE assays.

5.2.2.3. Each analyzer shall be a random access, discrete analyzer system with STAT interrupt capability and a primary tube sampling system capable of handling 100mm x 16mm, 100mm x 13mm, 75mm x 13mm, 64mm x 10.25 and 46mm x 10mm (microtainer) test tubes with standard or Hemaguard caps and screw caps. The analyzer will be capable of accommodating both Becton-Dickinson and Greiner tubes.

5.2.2.4. Analyzer throughput shall be measured as a function of number of STAT panels (see Table 5.1.) fully completed in 30-minutes.

5.2.2.5. The 30-min STAT panel includes the assays listed in Table 5.1. These assays shall (must) be analyzed from the same specimen with a maximum turn-around-time (automated pre-analytical processing to certification) of 30 minutes.

5.2.2.6. The analyzers shall (must) include the current e801 analyzers.

5.2.3.1. POST-ANALYTICAL STORAGE - The contractor will support (to include instruments, ancillary equipment, maintenance, services, repairs, support, and parts as required in order to maintain the systems in optimal operating condition, and any installation and removal) the post-analytical storage in use at MAMC.

5.2.3.2. Post analytical storage must be bidirectional.

5.2.3.3. Post analytical must be able to remove sample from storage, place sample back onto automation line, place sample back onto analytical instrument, and return to storage without any manual manipulation.

Table 5.1. - Assays that must be completed from the same specimen within 30 minutes as a STAT panel.

Alanine Amino Transferase (ALT) Creatinine Kinase, Total (CK)

Aspartate Amino Transferase (AST)

Bilirubin (Direct/Conjugated) Glucose

Bilirubin (Total) Chorionic Gonadotropin (hCG)

NT-pro BNP Potassium

Procalcitonin

Calcium (Total) Protein, Total

Carbon Dioxide (CO2) Sodium

Chloride Troponin T, high sensitivity

Creatinine, enzymatic Urea Nitrogen

Phosphorous Magnesium

Amylase Lipase

Table 5.2 -Assays That Must be Approved for Use With Plasma Samples

Acetaminophen Cortisol; Total Lactate Dehydrogenase

(LDH)

Alanine Amino Transferase (SGPT)

C-Reactive Protein

(CRP)

Myoglobin

Albumin C-Reactive Protein, High Sensitive

Phosphorus Inorganic (Phosphate)

(HS-CRP)

Alcohol (Ethanol) Creatinine Potassium

Alkaline Phosphatase Creatinine Kinase (CK) Total

Protein, Total

Amylase Digoxin Salicylate

Aspartate Amino Transferase

Gentamicin Sodium

(SGOT)

Bilirubin (Direct) Glucose Theophylline

Bilirubin (Total) Glutamyl transferase, Gamma (GGT)

Troponin

Calcium (Total) Gonadotropin, Chorionic (hCG)

Urea Nitrogen

Carbamazepine Homocysteine Vancomycin

Carbon Dioxide

(CO2)

Lactate (Lactic Acid) Cholesterol

Chloride Low Density Lipoprotein (LDL-

High Density Lipoprotein (HDL)

Magnesium Direct) Progesterone

Uric Acid Estradiol Thyroid Specific Hormone (TSH)

Vitamin D Iron fT4

Prolactin Transferrin

Table 5.3 - Listing of Assays That Must be Approved for Use With Urine Samples

Calcium (Total) Potassium

Creatinine Protein, Total

Microalbumin (Quantitative) Phosphorus Inorganic (Phosphate)

Urea Nitrogen Sodium

Amylase Glucose

Chloride Magnesium

Uric acid

Amphetamines

Barbiturates

Benzodiazepine

Fentanyl

PCP

THC

Buprenorphine

Cocaine

Meth

Opiates

Oxycodone

Table 5.4 - Listing of Assays That Must be Approved for Use With CSF and Body Fluid Samples

Glucose Protein

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

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

5.2.6. 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. The Contractor is responsible to ensure the UPS remains operable throughout the length of the contract.

5.2.7. 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.

5.2.8. The analyzer systems shall provide open channels to accommodate third party assays listed in Appendix 2. The Contractor shall provide consumables, reagent containers, etc. in sufficient quantities and quality to perform these assays.

5.2.9. The analyzer systems shall (must) be seismically mounted. The Contractor will coordinate with the Government's Facility Services ahead of installation to identify specific requirements after award of contract. See3.1 above.

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.

All assays must be FDA approved.

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 or specimen dilutions.

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 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 kit should decrease.

5.3.2. The analyzer shall (must) be capable of maintaining calibration curves for all of the assays listed in Appendix 1 simultaneously.

5.3.3. The assays listed in Appendix 1 shall (must) be present on the analyzer at all times.

5.3.4. The assays listed in Table 5.2 shall (must) be approved by the FDA for plasma as well as serum samples. In addition, the Contractor shall clearly demonstrate an acceptable correlation, as defined in section 5.1.3. between plasma and serum values during the initial set up and correlation studies.

5.3.5. The analyzers provided shall (must) have the capability to add/change out reagents/reagent packs with only a minimal calibration/quality control requirement (i.e., shall (must) allow the user to calibrate any assay, remove the assay reagents/reagent packs for a period of undetermined time, and then reload the reagents/reagent packs to run the assay without the need for recalibration in most instances, thereby allowing the user to meet work test scheduling requirements specific to the location).

5.3.6. The assays listed in Table 5.3 shall (must) be approved by the FDA for urine samples.

5.3.7. The assays listed in Table 5.4 shall (must) be approved by the FDA for CSF and Body Fluid samples.

5.3.8. The Contractor shall optimize the specific arrangement of the reagents/reagent packs for assays that are routinely maintained on the analyzer during the initial installation of the analyzer and when a new assay is added to the test menu. The Contractor shall (must) ensure that all required reagents/reagents packs are accounted for in the loading plan for the assays that are routinely maintained on the analyzer (assays to be routinely maintained on each of the analyzers will be specified at the time of installation).

5.3.9. The Contractor shall provide an estimate of the yearly quantities of reagent/reagent packs and calibrators/standards required to perform the volume of patient reportable tests for each assay as provided in Appendix 1.

5.3.9.1. The Contractor shall pre-program and adjust program as necessary for all quality control, maintenance, calibrator material in vendor provided racks or testing containers.

5.3.9.1.1 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), specimen dilutions, and for troubleshooting of out-of-control assays be considered when calculating the yearly requirements.

5.3.9.2 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.

5.3.10. Reagents shall (must) have a minimum shelf life of three (3) months upon receipt by the Government, or, 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.

5.3.11. The Contractor shall sequester the test reagents and ensure that no more than three (3) lot changes for reagents occurs per contract year.

Assays shall (must) be stable enough to maintain a single control run per 24 hours of testing. Calibration frequency for all assays outlined in Table 5.1 shall not be less than once every twenty (20) days under routine operations. This calibration frequency does not include calibrations required following instrument repair or servicing (e.g., field service type maintenance or service, major changed in instrument components that affect readout, QC troubleshooting, etc.) or other instances as described in the Laboratory QA Program or approved by the Laboratory Director.

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

5.3.12.1. Be provided by the manufacturer of the equipment.

5.3.12.2. Be marked with the required storage temperature.

5.3.12.3. 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.

5.3.13. 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.

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

5.3.14. Deliveries. Deliveries of required items shall be requested by the government on a as needed basis. 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 back-order exceeds 10 working days, the Contractor shall provide testing services through local sub-contract at their cost.

5.3.14.1. 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. Contractor will notify the Government via email and telephonic message when an order is not available or capable to be shipped within these timelines.

5.3.14.2. For all orders, standing or emergency, the Contractor shall notify via email the designated points of contact that orders have shipped and provide a tracking number.

5.3.15. 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 at MAMC 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 at MAMC 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 2 business days after completion of a repair, the Contractor's representative shall furnish via email 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 failure, the Contractor's qualified service technician shall be on-site at MAMC 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 at MAMC 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 at MAMC 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 at MAMC 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 year.

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

5.5.3.1 The on-site operator training at MAMC 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., Cerner Millenium (MHS GENESIS). The Contractor shall (must) have an established driver compatible for interfacing the analyzer with the Cerner. The interface between Cerner 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. The Government utilizes Bio-Rad quality control materials. The software program shall have the capability to incorporate Bio-Rad's on-line/on-board QC analysis package, Unity(TM) Interlaboratory Program and Unity QC Data Management Solutions.

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.