Urinalysis Analyzer SOW.docx

STATEMENT OF WORK

URINALYSIS REAGENTS

1. GENERAL REQUIREMENTS:

1.1. SCOPE OF WORK: The Contractor shall provide Urinalysis Reagents used in support of the urinalysis mission at Madigan Army Medical Center, Joint Base Lewis McChord, WA. The Contractor shall be responsible for furnishing a fully automated Urinalysis analyzer system (inclusive of instruments, ancillary equipment (computer, external drives, printer, UPS, sturdy wheeled table, etc.), maintenance, services, repairs, support, and parts as required in order to maintain the systems in optimal operating condition at no extra cost to the Government. The Contractor shall perform to the standards of this Statement of Work (SOW).

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. 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). 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, 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.

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

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. 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.

1.5. 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.

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, 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

QA

Quality Assurance

QA&I

Quality Assessment & Improvement

QC

Quality Control

SOW

Statement of Work

3. SPECIFIC TASKS

3.1. DESCRIPTION

3.1.1. The Contractor shall provide a fully automated, Urinalysis analyzer systems capable of providing a complete chemistry and sediment analysis to include all of the required assays as listed in Table 1. The analyzer system will be from a single contractor. The system, as defined in 3.1.1.1 shall provide redundancy (to ensure continuous operations). The Contractor shall provide the system, initial training for 2 key operators and 40 on-site personnel, supplies, reagents, unscheduled maintenance, and preventive maintenance for the system. 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 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 or Desired 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.

SEDIMENTANALYTES

ANALYTE

ANALYTE

Red Blood Cells (RBC)

Unclassified Crystal

White Blood Cells (WBC)

Triple Phosphate Crystal

White Blood Cell Clumps

Calcium Oxalate Crystal

Bacteria

Uric Acid Crystal

Budding Yeast

Calcium Carbonate Crystal

Hyphenated Yeast )

Calcium Phosphate Crystal

Squamous Epithelial cells

Leucine Crystal

Transitional Epithelial Cell

Tyrosine Crystal

Renal Tubular Epithelial cell

Cystine Crystal

Oval Fat Bodies

Amorphous Sediment

Mucus

Non-specific Epithelial cell

Red Blood Cell Clumps

Unclassified Cast

Sperm

Hyaline Cast

Waxy Cast

Epithelial Cast

White Blood Cell Cast

Cellular cast

Red Blood Cell Cast

Broad Cast

Granular Cast

Fatty Cast

CHEMISTRY ANALYTES

Color

Ph

Clarity

Specific Gravity

3.1.1.1. Any and all analyzers will include a fully automated urine chemistry analyzer, sediment analyzer coupled with an automated digital imaging analyzer equipped with integrated barcode readers, and tube rack based sample processors that are physically connected to each other.

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

- Floor standing model with reagent storage/tables/cart or a movable pedestal (floor stand) with shelf for supplies and computer peripherals (CPU, printer, etc.).

3.1.1.2. The analyzer system will be located at:

Madigan Army Medical Center 9040 Jackson Drive Tacoma, WA 98431

3.1.2. 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.

3.1.3. 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.

3.1.3.1. 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 analytical measurement range (AMR), 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.

3.1.3.1.1. 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.

3.1.3.2. 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 as determined by the Laboratory Director (e.g. EP Evaluator®), to provide technical assistance for the method validation studies. The assigned Technical Service Representative will be responsible for the entire Method Validation.

3.1.3.3. 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.

3.1.3.4. 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.

3.1.4. The Contractor shall provide 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.

3.1.5. 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 and meet all regulatory agency (e.g., CAP, TJC, etc.) requirements. The MSDS 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.

3.1.6. 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.

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

3.2. ANALYZERS.

3.2.1. Analyzers shall have fully automated, discrete random access capabilities with the ability to scale-up to meet future testing/ workflow needs.

3.2.1.1. There shall (must) be a single point of specimen entry for the routine analysis of all required tests. There shall (must) be an optional separate specimen point of entry for STAT specimens.

3.2.1.2. The analyzer(s) must provide final results without operator re-classification of urine particles.

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

· Instrument with throughput not less than 50 complete urinalysis including sediment analysis per hour.

· Sample size is no more than 3mls in all modes.

· Possesses a touch screen/flat screen monitor for operator interface.

· Possesses a single TCP/IP port to connect to the Laboratory Information System.

· Comes equipped to perform continuous, random and statistical analysis; capable of real time or (on-line) Quality Control.

· Capable of handling 16mm X 100mm disposable plastic tube in the standard specimen rack.

· Chemical analysis that includes color, clarity, specific gravity, glucose, protein, nitrite, leukocyte esterase, blood, bilirubin, urobilinogen, and ketones.

· Capable of performing automatic color correction to compensate for darkly colored urines and correct result for applicable parameters.

· Must be able to remove common interferences through a warming function, reagents that dissipates amorphous urate and phosphate material or other technology.

· Capable of producing microscope quality like images.

· Analyze urine sediment particles in their near-native state so as not to physically or biochemically alter their morphology

· Capable of performing auto-validation for Red Blood Cells, White Blood Cells, Casts, Bacteria, and Epithelial Cells.

· Provide retrievable results of urine sediment specific to each sample. Must use a 2D compatible digital barcode reader to provide a positive identification for all specimen tube IDs in the form of an image. Tube rack and specimen IDs must be read twice prior to aspiration.

· Positive sample tube identification (sample tube bar-code must be read before, during and after aspiration).

· Positive tube rack position identification (tube rack and position bar-code read at time of aspiration).

3.2.3. The analyzer system shall provide users with rapid, reliable test results that are critical for patient care. The analyzer system shall (must) be capable of performing in low, medium, and high volume work periods to produce results that are accurate and precise throughout the manufacturer’s stated linearity/analytic measurement range.

3.2.4. 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.

3.2.5. 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.

3.3. REAGENTS.

3.3.1. 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.

3.3.1.1. 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.

· Reagents must have a shelf life not less than of 3 months upon receipt at the Receiving Activity (consignee), or as stated within the individual line item (i.e. Delivery Ticket, Invoice).

· Controls will have shelf life of not less than 4 weeks.

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

· All test kits will be provided as follows:

· Be provided by the manufacturer of the equipment.

· Delivered on time (see 5.11.3.3.1), at the appropriate storage temperature, and marked with any required temperature controls as necessary.

· Routine or scheduled orders will arrive within one week before or after the scheduled date of delivery. Emergency orders will be delivered within 24 hours after the order is placed.

· Be compatible with all reagent packs used with the Analyzers.

· 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 reagents provided will be identical to those used in the FDA 510K approval application. 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.

3.3.1.1.1. 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 within the Regional Health Command - Pacific. 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.

3.3.1.1.2. 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.

3.4. ANCILLARY MAINTENANCE AND SERVICE

3.4.1. 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.

3.4.1.1. 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.

3.4.1.2. 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.

3.4.1.3. 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.

3.4.2. 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.

3.4.2.1. 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.

3.4.2.2. 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.

3.4.2.3. 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.

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

3.4.2.4. 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.

3.4.2.4.1. The Contractor shall notify the COR or ACOR of the exact date and time for performance of a preventive maintenance service no less than 10 days prior to the scheduled preventive maintenance services.

3.4.2.5. 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.

5.4.2.6. 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

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

3.4.3. SERVICE:

3.4.3.1. 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.

3.4.3.2. 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.

3.4.3.3. 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.

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

3.4.3.5. 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.

3.4.3.6. Should both analyzers become inoperable, the technical repair specialist shall be on-site within 4 hours.

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

3.4.3.7. 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.

3.4.3.7.1. 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.

3.4.3.8. 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) (e.g., non-availability of parts, etc.) for non-compliance.

3.4.3.9. 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.

3.5. TRAINING:

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

3.5.1.1 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.

3.5.2. 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.

3.5.3. 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, troubleshooting procedures, performance of operator-level periodic preventive maintenance procedures, and use of the data management/quality control software.

3.6. INFORMATION MANAGEMENT.

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

3.6.2 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.

3.6.2.1 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.

3.6.2.2 The QC software shall provide the capability to write user defined Westgard QC Rules. In addition it shall integrate with the result manager for autoverification 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.

3.6.3 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.

3.6.3.1 All software shall be the most current version, be fully supported by the software manufacturer and be current with all security updates. Software updates will be provided at no additional cost to the government throughout the term of the contract.

3.6.3.2 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).

3.6.3.3 The results management application shall manage patient data, sample and QC results by offering archiving, status, calculation of results and long-term results storage.

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

3.7. DELIVERY OF EQUIPMENT:

3.7.1. The Analyzers shall (must) be delivered to the location as indicated below within 30 calendar days after contract award. Equipment setup, on-site training, method validation studies, and analytical measurement range/linearity verification, shall (must) be completed by Contractor personnel. During the initial implementation, a dedicated technical representative must be available on site throughout the entire implementation period. Substitutions must be coordinated with the COR.

3.7.2. PRIMARY LOCATIONS OF COMPLETE SYSTEMS:

3.7.2.1. The system shall be delivered and installed at:

Madigan Army Medical Center Department of Pathology 9040 Jackson Dr Tacoma, WA 98431

3.7.2.2. Exact installation locations at the primary locations shall be coordinated by the Contractor with the point of contacts listed below:

4. INFORMATION SECURITY

4.1. TELECOMMUNICATION

4.1.1. All Contractor systems that communicate with Department of Defense (DoD) systems shall interconnect through established Virtual Private Network (VPN) Business to Business (B2B) gateway. The VPN B2B type required shall be determined only after an official VPN B2B request submission to appropriate approving agencies. The required VPN B2B type and procedure for establishing that type will be disclosed to the contractor upon discovery at a time after contract award. All software must be able to pass Government testing and review and be awarded a Authority To Operate (ATO) from DHA. Submission of the ATO request must be completed within six (6) months of contract award.

4.1.2. The Contractor shall follow Army Regulation 25-1, “Army Knowledge Management and Information Technology, AR 25-2, “Information Assurance (IA)”, and DoD 6025.18-R, DoD Health Information Privacy Regulation.

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

4.1.4. The Contractor shall comply with DoD guidance regarding allowable ports, protocols and risk mitigation strategies and will provide, maintain and configure VPN concentrator that complies with DoD security standards.

4.1.5. All costs for VPN hardware and software shall be incurred by the Contractor.

4.1.6. The Contractor shall initiate, maintain, and document personnel security investigations appropriate to the Business Associate Representative’s responsibilities and required access to MEDCOM Sensitive Information (SI) as determined by the site Chief Information Officer.

4.1.7. The Contractor shall validate that systems authenticate users through the use of the Common Access Card (CAC) or CAC alternative as a part of a two-factor authentication mechanism on the business partner side of the VPN. The Contractor shall also identify the exact location from which remote operational control will take place from, the encryption that will be used, and how the vendor's technical users will maintain secure logon.

4.2 DEFENSE HEALTH AGENCY (DHA) CYBER LOGISTICS (CYBERLOG) CYBERSECURITY/ RISK MANAGEMENT FRAMEWORK (RMF) REQUIREMENTS

4.2.1 The Contractor shall provide an up to date operating system that includes all software patches and updates for all programs installed on the operating system. The operating system and all the programs on the operating system must stay up to date with all software patches and updates throughout its lifecycle.

4.2.2 The Contractor shall include all costs to achieve the initial Authority to Operate (ATO) and maintain it during the lifecycle.

4.2.3 The Contractor shall pass pre-validation technical screening (vulnerability scans utilizing NESSUS, Security Content Automation Protocol (SCAP) scans, and Security Technical Implementation Guides (STIGs) checklists) within 6 months of the contract award.

5. PROGRAM MANAGEMENT

5.1. GENERAL. The Contractor shall provide comprehensive Program/Project Management services.

5.2. Program Manager (PM). The Contractor shall provide a dedicated PM, who shall be responsible for the initial instrument implementation, instrument upgrades, implementation of new methods or procedures and optimization of workflow processes and procedures.

5.2.1. The PM, and an alternate who shall act for the Contractor when the PM is absent, shall be designated in writing to the Contracting Officer and Contracting Officer Representative (COR) within 10 days of contract award.

5.2.2. The PM and alternate PM shall have full authority to act for the Contractor on all contract matters relating to daily operation of this contract.

5.2.3. The PM and/or alternate shall be actively engaged in all aspects of this SOW.

5.2.4. The Contractor shall provide an Information Technology Project Manager for implementation of the instrument interface and middleware.

5.2.4.1. The IT PM shall have demonstrated working knowledge of Information Security Requirements specific to DoD installations.

5.2.4.2. The IT PM shall have a demonstrated working knowledge and competency in the installation, troubleshooting and development of the instrument interface requirements as they relate to the government’s LIS.

5.2.5. The PM or alternate PM shall be available during normal duty hours to meet on the installation with Government personnel (designated by the Contracting Officer) to discuss problem areas. After normal duty hours, the manager or alternate shall be available within 48 hours.

5.2.6. The PMs (both PM and IT PM) shall hold current certification as a Project Management Professional (PMP) through a nationally recognized accrediting agency (e.g. The Project Management Institute). Certificates shall be provided to the Government upon appointment to this contract.

5.2.7. The PM and IT PM shall not have other assigned Sales, Field Services or Technical Service responsibilities.

5.3. Specific instrument layout and selection of pre-analytic, post-analytic and track delivery systems will be determined by a detailed, comprehensive workflow analysis.

5.3.1. The workflow analysis shall be conducted IAW commonly accepted industry standards for maximizing efficiency.

5.3.2. The workflow analysis shall focus on maximizing efficiency, menu and throughput, and minimizing turn-around-times.

(End Performance Based Work Statement)

Appendix 1 Mandatory Tests and Estimated Patients/Year

APPENDIX 2 - Relevant CLSI Standards Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard (AUTO01-A) Laboratory Automation: Bar Codes for Specimen Container Identification; Approved Standard (AUTO02-A2) Laboratory Automation: Communications With Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard—Second Edition (AUTO03-A2) Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard (AUTO04-A) Laboratory Automation: Data Content for Specimen Identification; Approved Standard (AUTO07-A) Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard (AUTO09-A) Autoverification of Clinical Laboratory Test Results; Approved Guideline (AUTO10-A) IT Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard (AUTO11-A) Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline— Third Edition (C28-A3) Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition (EP05-A2) Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline (EP06-A) Interference Testing in Clinical Chemistry; Approved Guideline—Second Edition (EP07-A2) Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline—Second Edition (EP09-A2) Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures; Approved Guideline-Third Edition (EP10-A3) Laboratory Statistics — Standard Deviation; A Report (EP13-R) Evaluation of Matrix Effects; Approved Guideline—Second Edition (EP14-A2) User Verification of Performance for Precision and Trueness; Approved Guideline-Second Edition (EP15-A2) Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline (EP17-A) Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline—Second Edition (EP18-A2) Estimation of Total Analytical Error for Clinical Laboratory Methods; Approved Guideline (EP21-A) Determination of Serum Iron, Total Iron-Binding Capacity and Percent Transferrin Saturation; Approved Standard (H17-A) Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems; Approved Standard—Second Edition (LIS01-A2) Specification for Transferring Information Between Clinical Laboratory Instruments and Information Systems; Approved Standard—Second Edition (LIS02-A2) Standard Guide for Selection of a Clinical Laboratory Information Management System (LIS03-A) Standard Practice for Reporting Reliability of Clinical Laboratory Information Systems (LIS06-A) Standard Specification for Use of Bar Codes on Specimen Tube in the Clinical Laboratory (LIS07-A) Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems (LIS08-A) Standard Guide for Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked Architecture (LIS09-A)