RFQ 21Q0032- Attach 1 - SOW -15 MAR 21.pdf

STATEMENT OF WORK

FOR

CLINICAL LABORATORY

CHEMISTRY AND IMMUNOASSAY

TESTING SYSTEM

AT 374 MDG, YOKOTA AIR BASE, JAPAN

374 MDSS/SGSL

Yokota Air Base

15 March 2021

STATEMENT OF WORK (SOW) FOR

CLINICAL LABORATORY CHEMISTRY AND IMMUNOASSAY TESTING SYSTEM

1. SCOPE. The Contractor shall provide one (1) fully automated random access chemistry analyzer, capable of performing the chemistry and immunoassay tests listed in Table A1, with a minimum throughput of 150 tests per hour, all sample and calibrator dilutions must be performed automatically. The Contractor shall provide all training, supplies, reagents, unscheduled maintenance, and preventive maintenance for the equipment.

All costs will be calculated on reagent rental basis based on the number of patients listed for each Mandatory Test or Desired Test listed in Table A1. Costs shall be amortized over the total number of tests described in this SOW and factored into the cost per reportable or patient billable.

1.1. DELIVERY OF EQUIPMENT:

1.1.1. The Analyzers must be delivered to the location as indicated below within (2)-two weeks 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.

1.2. PRIMARY LOCATION OF COMPLETE SYSTEM:

1.2.1. The system shall be delivered and installed at:

374th Medical Group Clinical Laboratory Building 4408 Unit 5071

Yokota Air Base, Japan 96328-5071

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

Clinical Laboratory Flight Commander 374th Medical Group Tel: 011-81-42-552-2510 Ext. 5-3551

1.3. SAFETY DATA SHEETS (SDS): The Contractor shall provide safety data sheets (SDS) for each item delivered under this contract that is considered to be HAZARDOUS MATERIAL by its representative government.

The SDS shall contain information on the hazards associated with each specific chemical or material. The SDS shall be printed in the English language and shall contain as a minimum 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.

1.4. CLASSIFICATION:

1.4.1. 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 Clinical Laboratory Improvement Amendment (CLIA), Clinical and Laboratory Standards Institute (CLSI), and College of American Pathologists (CAP) quality management 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.)

1.4.2. Within 10 working days after contract award, the Contractor shall coordinate and conduct a post award site visit to the 374th Medical Group Laboratory for the purpose of coordinating a schedule for equipment installation.

1.4.3. 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.

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

1.4.5. The electrical requirement for this equipment must be 220V/50Hz.

1.4.6. English programs, keyboards, and displays, are required for all instruments and printer.

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

1.5. ANALYZER:

1.5.1. 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 data management system’s quality control program 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.

1.5.2. The analyzer will utilize the following operational types: Batch, random access, discrete, and continuous random access. The analyzer must have the on-board ability to maintain reagents at the proper storage temperatures for the assays listed in Table A1 below. All assays must be Food and Drug Administration (FDA) approved.

1.5.3. The analyzer will be equipped with STAT (or immediately) interrupt capability and a primary tube sampling system capable of handling 75 mm x 13 mm or 100 mm x 13 mm standard or Hemaguard (or equivalent) test tube sizes, including pediatrics and micro container, manufactured by BD and Greiner (current DoD supplier).

1.5.4. The analyzer shall not require a plumbed water source.

1.5.5. Water sources must remain sealed to prevent contamination. Water exposed to contaminants or requiring periodic decontamination processes are not acceptable.

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

1.5.7. 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.

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

1.5.9. The analyzer systems shall be 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 at least 15 to 20 minutes.

1.5.10. The analyzer shall be capable of maintaining calibration curves for all of the assays, listed in Table A1 below, simultaneously. The assays listed in Table A1 must be able to be maintained and run on the analyzer at all times.

1.6. REAGENTS:

1.6.1. The Contractor shall provide the reagents and shall coordinate exact quantities and the shipment schedule with the Government Representative (GR) prior to shipment.

1.6.1.1. The workload listed in Table A1 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.

1.6.1.1.1. The actual workload may fluctuate in the basic year of the contract due to changes in the distribution of patient care. Table A1 provides the estimated workload for contract. All workload numbers represent total estimated patient reportable/billable results for the indicated year.

1.6.1.1.2. 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.

1.6.2. All assays listed in Table A1 must be approved by the FDA for serum and/or plasma samples unless noted as “Cerebrospinal Fluid (CSF)” or “Urine” tests. Those assays noted with “CSF” or “Urine” must be FDA approved to be run on CSF or Urine.

1.6.3. All reagents need not be maintained on an analyzer at the same time, but the analyzers provided must have the capability to add/change out reagents/reagent packs with only a minimal calibration/quality control requirement.

1.6.4. The Contractor will 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 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 to be specified at the time of installation).

1.6.5. 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 Table A1.

1.6.5.1. The Contractor shall ensure that requirements for routine quality control runs, 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 or manufacturer required time period), and for troubleshooting of out-of-control assays be considered when calculating the yearly requirements.

1.6.5.1.1. Quality Control Material and Performance perform within the manufacturer’s stated/published package inserts.

1.6.5.2. 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 Table A1.

1.6.6. Reagents must have a minimum shelf life of three months (unless specific manufacturer expiration dates cannot reach the 3 month target in which case they must have a minimum shelf life of 45 days) upon receipt by the Government, or, 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.

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

1.6.7.1. Inclusive of an English language package insert.

1.6.7.2. Be provided by the manufacturer of the equipment.

1.6.7.3. Be marked with the required storage temperature.

1.6.7.4. Be ready for use, not requiring additional reconstitution.

1.6.7.5. Be maintained at the proper storage temperature during transportation from the Contractor’s storage facility to the Government acceptance site and be delivered on time at the appropriate storage temperature.

1.6.8. 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.

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

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

1.6.9. 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.

Table A1 – Listing of Required Assays and Estimated Annual Patient Testing Volume (Does not include calibrators, controls or standards)

TEST NAME ANNUAL TEST NAME ANNUAL

Acetaminophen 170 Potassium (K+) 2400 Albumin 2100 Lactate 100 Alcohol 290 Lactate Dehydrogenase (LDH) 370 Alkaline Phosphatase (ALP) 2100 Lipase 350 Alanine Aminotransferase (ALT) 2100 Magnesium 240 Amylase 200 Sodium (Na+) 2400 Aspartate Aminotransferase 2100 Phosphorus 470 HCG (quantitative) 475 Protein-CSF 25 Bilirubin-Conjugated 950 Salicylate 160 SARS-CoV-2 Antigen 1200 Bilirubin-Unconjugated 950 Total Bilirubin 1900 Cholesterol 1300 Total Protein 1900 Creatine Kinase (CK) 430 Triglycerides 1240 Creatine Kinase-MB (CK-MB) 100 Thyroid Stimulating Hormone (TSH) 1200 Creatinine 2400 Troponin I (cTnI) 250 Creatinine, Urine 160 Urine Albumin 160 C-Reactive Protein (CRP) 450 Urine Protein 160 Calcium 2400 Urea 2400 Chloride (Cl-) 2400 Uric Acid 180 ECO2 2400 Vancomycin 100 Free Thyroxin (Free T4) 480 Hgb A1C 580 Gentamicin 70 direct High-Density Lipoprotein (dHDL) 1300 Gamma-Glutamyl Transferase (GGT) 380 direct Low-Density Lipoprotein (dLDL) 1300 Glucose 3000 Glucose-CSF 25

1.7. MAINTENANCE AND SERVICE:

1.7.1. 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 1 (below) are the minimum guidelines that will be referenced when conducting method validation. Additional guidelines may be required, depending on regulatory requirements.

17.1.1. 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 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.

1.7.1.2. A Method Validation must be submitted at the time of solicitation. 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.

1.7.1.3. 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.

1.7.1.4. 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.

1.7.1.5. 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.

1.7.1.6. 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.

1.7.2. 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.

1.7.2.1. 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.

1.7.2.2. 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 will 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.

1.7.2.3. 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 in accordance with paragraph 1.7.2. of this SOW.

1.7.2.4. 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.

1.7.2.5. 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) as described in paragraph 1.7.6.6. and 1.7.6.7. below.

1.7.2.6. 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.

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

1.7.2.8. 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.

1.7.3. 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 U.S. Government.

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

1.7.5. 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.

1.7.5.1. 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.

1.7.5.2. The use of two-way radios, as well as smoking, is prohibited within the 374th Medical Group and its clinics.

1.7.5.3. Prior to performing Scheduled Maintenance and Unscheduled Repair Services work, the Contractor's representative shall report to and obtain from the Biomedical Equipment Technician (BMET) department, at the MTF, a Visitors Badge. The badge must be returned to the BMET department prior to departing the MTF.

1.7.5.4. 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 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

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

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

1.7.5.7. Safety Inspections shall be performed at least annually in accordance with NFPA 99, Chapter 7. This regulation can be reviewed in the BMET department.

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

1.7.6. SERVICE:

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

1.7.6.2. 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.

1.7.6.3. 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.

1.7.6.4. Scheduled routine services shall be performed between 0730-1630 Monday-Friday, excluding Federal Holidays/Family days.

1.7.6.5. 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 instrument maintenance manual), safety and calibration as required by this SOW. The Contractor shall make best efforts to have equipment repaired and operational within 48 hours after initial response by the Contractor.

1.7.6.6. Upon analyzer failure, the Point of Contact or assigned technician for the Clinical Laboratory shall establish telephonic contact within 60 minutes to the Contractors 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.

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

1.7.6.8. 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.

1.7.6.9. In the event the automated random access chemistry analyzer is available for upgrade, the Contractor shall notify the Government within ten (10) calendar days of knowing the fact and coordinate the installation schedule with the Government.

1.8. TRAINING:

1.8.1. The Contractor will provide initial on-site operator training to all technicians assigned to the 374th Medical Group Clinical Laboratory prior to initiation of use of the analyzer for patient testing. In addition, the Contractor will provide training for two (2) primary operators, at the Contractor’s training site, prior to delivery and installation of the analyzer.

1.8.2. The Contractor shall provide two training slots per contract year, at the Contractor’s training site, at no additional cost to the Government.

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

1.9. INFORMATION MANAGEMENT:

1.9.2. The analyzer system shall be capable of interfacing with the military hospital computer system, i.e., the Composite Health Care System (CHCS) and/or future military approved Laboratory Information System (LIS). The Contractor shall have an established driver compatible for interfacing the analyzer with the CHCS or other LIS. The interface between CHCS or other LIS and the analyzer shall be bi- directional.

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

1.9.4. 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.

1.9.4.1. 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.

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

1.9.5. Data Management system shall 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.

1.9.5.1. 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.

1.9.5.2. 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 LIS.

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

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

2. GENERAL REQUIREMENTS.

2.1. CONTRACTOR PERSONNEL:

2.1.1. Contract Manager. 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 (CO).

2.1.1.1. 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.

2.1.1.2. 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 CO) to discuss problem areas. After normal duty hours, the manager or alternate shall be available within 72 hours.

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

2.1.2.1. 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.

2.2. Physical Security. The Contractor shall be responsible for safeguarding all government property provided for Contractor use or access.

2.3. HOURS OF OPERATION:

2.3.1. 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.

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

2.3.2. 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.

2.3.3. 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 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.

2.4. Records. The Contractor shall maintain all records necessary to comply with regulatory requirements and 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. 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.

2.5. Removal of Equipment. The Contractor shall not remove any equipment from the Government work site without prior approval of the GR or his/her designated representative.

3. GOVERNMENT-FURNISHED FACILITIES, EQUIPMENT, MATERIAL, AND SERVICES.

3.1. General. The Government will provide, without cost to the Contractor, the facilities, equipment, materials, and services listed below.

3.1.1. 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 CO. 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.

3.1.2. Equipment. No equipment will be provided

3.2. Materials. No materials will be provided.

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

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 and services required under this contract.

4.2. Transportation. Transportation is the responsibility of the Contractor. The Government will not provide transportation.

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

4.4. SAFETY DATA SHEETS (SDS): The Contractor shall provide SDS for each item delivered under this contract that is considered to be HAZARDOUS MATERIAL by its representative government. The SDS shall contain information on the hazards associated with each specific chemical or material. The SDS shall be printed in the English language and shall contain as a minimum 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.

4.5. INFORMATION SECURITY:

4.6. SPECIAL REQUIREMENTS FOR PROTECTED HEALTH INFORMATION:

4.6.1. 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:

4.6.2. Notify the MTF HIPAA Security Manager.

4.6.3. Follow all Department of Defense (DoD) requirements for secure disposal, destruction, and/or sanitization of all equipment that contained PHI.

5. REGULATORY REQUIREMENTS.

5.1. 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 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:

5.2. 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.

5.3. Publications:

5.3.1. 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.

APPENDIX 1

Relevant CLSI Standards (refer to the most current edition of each guideline)

Auto-verification of Clinical Laboratory Test Results; Approved Guideline (AUTO10-A) Body Fluid Analysis for Cellular Composition; Approved Guideline (H56-A)

Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline— Third Edition (C28-A3)

Determination of Serum Iron, Total Iron-Binding Capacity and Percent Transferrin Saturation; Approved Standard (H17-A)

Estimation of Total Analytical Error for Clinical Laboratory Methods; Approved Guideline (EP21-A) Evaluation of Matrix Effects; Approved Guideline—Second Edition (EP14-A2)

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)

IT Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard (AUTO11-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: Data Content for Specimen Identification; Approved Standard (AUTO07-A) Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard (AUTO01-A)

Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard (AUTO04-A)

Laboratory Statistics — Standard Deviation; A Report (EP13-R)

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)

Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline (EP17-A)

Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard—Third Edition (H15-A3)

Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard (AUTO09-A)

Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline—Second Edition (EP18-A2)

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 Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked Architecture (LIS09-A)

Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems (LIS08-A) 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)

User Verification of Performance for Precision and Trueness; Approved Guideline-Second Edition (EP15-A2)