Coagulation Statement Of Work.odt

STATEMENT OF WORK FOR

CLINICAL LABORATORY HEMOSTASIS TESTING SYSTEM

For United States Naval Hospital Guam

SCOPE:

The contractor shall provide two (2) fully automated coagulation analyzers capable of performing routine hemostasis assays listed in the attachment, with a minimum throughput of 180 tests per hour. The contractor shall provide all training, supplies, reagents, unscheduled maintenance, and preventive maintenance for the equipment.

DELIVERY OF EQUIPMENT:

The Analyzers must be delivered to the location as indicated below, within 90 days after contract award. Equipment setup, on-site training, method validation studies, and analytical measurement range/linearity verification, must be completed by vendor personnel within a period of time to ensure that equipment is fully operational on the date agreed to by mutual agreement between the contractor and the government. During the initial implementation, an English-speaking technical representative must be available telephonically 24 hours/ 7 days a week. All equipment displays and supporting literature must be in the English language.

Bldg 50 Farenholt Road Ste 1Y02 Agana Heights, Guam 96910

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

USNH GUAM LABORATORY POC

Vincent, Coto

LTJG, MSC, USN

Division Officer, Laboratory

U.S. NMRTC GUAM

PSC 455 Box 208

FPO, AP 96540

COMM: (671) 344-7156

Email: jayson.p.ravago.mil@health.mil

MATERIAL SAFETY DATA SHEETS (MSDS): The contractor shall provide material safety data sheets (MSDS) for each item delivered under this contract that is considered to be HAZARDOUS MATERIAL by its representative government. The MSDS shall contain information on the hazards associated with each specific chemical or material. The MSDS shall be printed in the English language and shall contain as a minimum the following information: identification of the specific hazard, the required practice for the safe use of the product, first aid procedures, and what to do in the event of a spill or other mishap or accident.

CLASSIFICATION

This equipment 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 guidelines and analyzer removal at the termination of the contract. For the purposes of this SOW the analyzer system includes at a minimum:

Analyzer

Peripherals (e.g. Uninterruptable Power Sources (UPS), instrument specific computer terminals and CPUs, printer capable of accepting 8.5”x11” paper and that meets U.S. specifications for toners and drums, etc.)

Within 10 working days after contract award, the contractor shall coordinate and conduct a post award site visit for the purpose of coordinating a schedule for equipment installation.

The contractor shall provide one (1) paper and one (1) CD 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 equipment that is serviced and maintained by the contractor.

The contractor shall be responsible for the collection and transportation of equipment upon expiration or termination of the contract.

The electrical requirement for this equipment must be 200V/60Hz.

English programs, keyboards, displays, on each instrument and printer.

The printer shall be able to accept 8.5”x11” paper and that meet U.S. specifications for toners and drums. It shall also be set to English.

ANALYZER.

The analyzer system 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 analyzer will utilize the following access modes: continuous reagent, consumable and sample loading capability. All assays must be FDA (Food and Drug Administration) approved.

The analyzer will be equipped with 2-5 STAT priority positions.

The analyzer must produce no, or minimal, liquid waste that will not require an eternal water source or drains.

The analyzer must not require changes to the facility infrastructure (i.e. plumbing) beyond electrical.

The analyzer systems will provide users with rapid, reliable test results that are critical for patient care. These analyzer systems 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.

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

The analyzer systems must come equipped with an un-interruptible power supply capable of providing all necessary electrical power to each analyzer system, to include the data management system, for 15 to 20 minutes.

The analyzer must be capable of maintaining calibration curves for all of the assays listed in the attachment. The assays listed must be able to be maintained and run on the analyzer at all times.

The contractor shall provide the reagents and shall coordinate exact quantities and shipment schedule with the Contracting Officer’s Representative (COR) prior to shipment.

The workload listed in the attachment 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 to troubleshooting.

The actual workload may fluctuate due to changes in the distribution of patient care. The attachment provides the estimated workload for the contract. All workload numbers represent total estimated patient reportable/billable results for the indicated year.

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.

1.4 REAGENTS

All assays listed in the attachment must be approved by the FDA for plasma samples

The contractor will optimize the specific arrangement of the reagents 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 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.

The contractor shall provide an estimate of the yearly quantities of reagent/reagent packs, calibrators/standards, and quality control materials required to perform the volume of tests for each assay as provided in the attachments.

The contractor shall ensure that requirements for routine quality control runs, routine calibration, periodic calibration/calibration verification and for troubleshooting out-of-control assays.

Quality Control material and performance perform within the manufacturer’s stated/published package inserts.

The contractor will also 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 the attachment.

Reagents must have a minimum shelf life of six months upon receipt by the Government. If this shelf life requirement cannot be met, the contractor must identify the guaranteed shelf life after receipt that can be accommodated in their response to the Solicitation for Bid.

Inclusive of an English language package insert.

Regents must be provided by the manufacturer of the equipment.

Reagents must be marked with the required storage temperature.

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.

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

Routine orders shall arrive within 5-10 calendar days of order placement.

The contractor shall make best efforts to deliver the reagents in the same lot or generation to avoid frequent calibration.

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.

METHOD VALIDATION

Method Validation will be conducted in accordance with method validation protocols established by the Laboratory’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.

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

1.5.3 The Method Validation will be completed and approved by the Laboratory Medical 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.

The contractor shall provide a qualified Technical Service Representative, who possesses a thorough knowledge of method validation. The assigned Technical Service Representative will be responsible for the entire Method Validation.

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.

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.

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

MAINTENANCE

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

1.6.2 The contractor is required to maintain all equipment installed under this contract except for repairs necessitated by willful damage or negligence on the part of the U.S. Government.

1.6.3 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 will be performed by contractor service personnel in accordance with requirements as specified in the contractor’s instrument maintenance manual.

1.6.4 The contractor shall provide a full unscheduled and preventive maintenance service 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.

1.6.5 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 attachment. 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.

1.6.6 The contractor shall provide Recall Information and Product Notifications in a timely manner via email and/or regular post office mail.

REPAIR:

1.7.1 Upon notification of equipment failure, the contractor’s qualified service technician shall establish elephonic contact within 60 minutes of the Government notification to the Contractors Customer Service “Hotline” and shall be on-site to provide unlimited emergency service.

1.7.2 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.

1.7.3 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.

1.7.4 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.

1.7.5 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 U.S. Government.

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

1.7.7 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.

The contractor shall notify the Point of Contact of the exact date and time for performance of a preventive maintenance service within ten (10) calendar days prior to the scheduled preventive maintenance services.

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

1.7.10 Within one (1) working day after completion of a repair, the contractor’s representative shall furnish the Point of Contact (POC) one (1) copy of a service report for all services performed. The service 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 or unscheduled repairs)

1.7.10.4 Location of services performed

1.7.10.5 Duration of performance (hours)

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

Name of technician

1.7.11 The Government and the contractor shall exchange hazard communication information before the commencement of any repair.

1.7.12 When required, the contractor shall comply with the Occupational Safety and Health Administration lockout and tag out procedures while performing maintenance on electrical equipment.

1.7.13 Preventive maintenance inspections and calibrations must be performed in accordance with contractor’s guidance as specified in the contractor’s instrument maintenance manual.

SERVICE:

1.8.1 The contractor shall provide direct customer service and support, 24 hours/7 days a week, to include hotline telephone service and on-call emergency repair service support, to assist operators in correcting equipment operation problems.

1.8.2 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.

1.8.3 The contractor shall provide a full unscheduled, preventive maintenance or scheduled periodic maintenance service (as required by the contractor’s instrument maintenance manuals) for the analyzer and any associated equipment provided by the contractor as part of the analyzer system at no additional cost to the Government.

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

1.8.5 The contractor’s qualified service technician shall be on site to provide routine services. Service requiring immediate repair and scheduled services for preventive maintenance (as specified in the instrument maintenance manual), safety and calibration as required by this statement of work. The contractor shall make best efforts to have equipment repaired and operational within 48 hours after initial response by the contractor.

1.8.6 Upon analyzer failure, the Point of Contact or assigned technician for the Clinical Laboratory shall establish telephonic contact within 60 minutes to the contractor’s Customer Service “Hotline”. The contractor shall be on-site to provide service (service requiring immediate repair) within 24 hours of establishing telephonic contact. The contractor shall make best efforts to have equipment repaired and operational within 48 hours after initial response by the contractor.

1.8.7 The contractor shall provide routine calibration services for those calibration procedures that are outside the scope of user responsibility.

1.8.8 The Contractor shall provide all necessary 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 no additional cost to the Government.

1.8.9 The U.S. government will make the equipment available to the contractor for servicing at such time and duration necessary to perform needed repairs.

TRAINING:

The contractor will provide initial on-site operator training to all technicians assigned to the Naval Hospital Guam Laboratory prior to initiation of use of the analyzer for patient testing. In addition, the contractor will provide training for at least one primary operator at the contractor’s training site prior to delivery and installation of the analyzer.

The contractor shall provide at least one training slots per contract year at the contractor’s training site at no additional cost to the government. This training shall include transportation to and from the training site and also include room and board.

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.

INFORMATION MANAGEMENT.

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

The analyzer shall utilize a windows based operating system. The system must be Windows 7 or later.

The analyzer system shall 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.

1.7.4 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.

1.7.5 The QC software shall provide the capability to write user defined Westgard QC Rules. 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.

1.7.6 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.

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.

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).

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

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

GENERAL REQUIREMENTS

CONTRACTOR PERSONNEL:

The contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person, and an alternate or alternates, who shall act for the contractor when the manager is absent, shall be designated in writing to the contracting officer.

The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract.

The contract manager or alternate shall be available during normal duty hours within 48 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 72 hours.

Contractor Employees. The contractor shall not employ persons for work on this contract if such employee is identified to the contractor by the contracting officer as a potential threat to the health, safety, security, general well- being or operational mission of the installations and their population.

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

PHYSICAL SECURITY. The contractor shall be responsible for safeguarding all government property provided for contractor use or access.

HOURS OF OPERATION:

Normal Hours of Operation. The contractor shall perform the services required under this contract during the following hours: Monday through Friday between the hours of 0730 - 1630.

Holidays. Routine equipment servicing and reagent delivery will not be required on standard Federal Holidays.

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.

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. 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.

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.

GOVERNMENT-FURNISHED FACILITIES, EQUIPMENT, MATERIAL, AND SERVICES

GENERAL. The Government will provide, without cost to the contractor, the facilities, equipment, materials, and services listed below.

FACILITIES. The Government will furnish the facilities for set-up and operation of the analyzer. 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.

EQUIPMENT. No equipment will be provided

MATERIALS. No materials will be provided.

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

Transportation. Transportation is the responsibility of the contractor. The government will not provide transportation.

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

MATERIAL SAFETY DATA SHEETS (MSDS): The contractor shall provide material safety data sheets (MSDS) for each item delivered under this contract that is considered to be HAZARDOUS MATERIAL by its representative government. The MSDS shall contain information on the hazards associated with each specific chemical or material. The MSDS shall be printed in the English language and shall contain as a minimum the following information: identification of the specific hazard, the required practice for the safe use of the product, first aid procedures, and what to do in the event of a spill or other mishap or accident.

SPECIAL REQUIREMENTS FOR PROTECTED HEALTH INFORMATION.

Whenever a contract is awarded that requires the vendor to collect, use, copy, access or store Protected Health Information (PHI) in commercial office space, the Contractors shall (must):

Notify the MTF HIPAA Security Manager.

Follow all DUA and DoD requirements for secure disposal, destruction, and/or sanitization of all equipment that contained PHI.

REGULATORY REQUIREMENTS.

GENERAL. Applicable documents - The latest practicable national (US) technical regulations are applicable for the manufacturing of the system. Contractor will comply with all U.S. laws pertaining to medical equipment. Contractor will also comply with all Department of Defense (DOD), Department of Air Force regulations and policies pertaining to medical equipment. Publications and forms not on the internet can be obtained from the MTF. These regulations include, but are not limited to, the following:

The Publications have been coded as mandatory or advisory. The contractor is obligated to follow those coded as mandatory only to the extent that they apply to this contract. Supplements, amendments, or changes to these mandatory publications may be issued during the life of the contract. Advisory publications may be used for information and guidance but are not binding for compliance.

Mandatory:

Public Law 91-596 29 Dec 70 Occupational Safety and Health Administration

Public Law 104-191 (Aug 1996) Health Insurance Portability and Accountability Act of 1996 Current Edition Joint Commission for Accreditation of Healthcare Organizations (JCAHO)

AFIP PAMPHLET 40-24; Clinical Laboratory Improvement Program (CLIP) policy mandated by DODI 6440.2 NFPA 99, Chapter 7.