Att.1- URINALYSIS SOW.docx

STATEMENT OF WORK

STATEMENT OF WORK

URINALYSIS INSTRUMENTATION

1. GENERAL REQUIREMENTS:

1.1. SCOPE OF WORK: The Contractor shall provide the lease of three (3) fully automated Urinalysis analyzer systems in support of William Beaumont Army Medical Center, Fort Bliss, TX (inclusive of instruments, ancillary equipment, maintenance, services, repairs, support, and parts as required in order to maintain the systems in optimal operating condition, and any installation and removal). This will include the following two areas: William Beaumont Army Medical Center Main Hospital, and Mendoza Clinic (SFCC). The Contractor shall perform to the standards of this Statement of Work (SOW).

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

1.2.1. The Contractor shall provide a Quality Control (QC) Plan that contains, as a minimum, the items listed in (below) to the Contracting Officer and Contract Officers Representative (COR) for acceptance not later than 21 calendar days AFTER the start of the contract (see Exhibit 1). The Contracting Officer will notify the Contractor of acceptance or required modifications to the plan. The Contractor shall make appropriate modifications and obtain acceptance of the plan by the Contracting Officer.

1.2.1.1. The QC Plan shall include:

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

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

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

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

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

1,2,4. Performance Evaluation Meetings.

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

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

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

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

1.3. HOURS OF OPERATION:

1.3.1. Normal Hours of Operation. Monday through Friday between the hours of 0730 – 1630 Mountain time for the Mendoza clinic. 24/7 Sunday-Saturday for WBAMC Main Hospital Center.

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 PWS.

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

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

NOTE: Any if the above Federal holidays fall on a Saturday, the holiday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday. Any holidays that are declared by Presidential Executive Order shall be observed in addition to and in the same manner as the holidays listed above

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

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

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

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

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

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

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

1.7. UPGRADE OF EQUIPMENT. Subject to mutual agreement between the Government and the Contractor, equipment/instrumentation may be upgraded within the specifications of the contract if workload exceeds the equipment’s/instrument’s current capacity. Additionally, the Government will delete/add reagent allocations through the life of this contract as a result of workload volume variations or changes to clinical practice standards. Any such change to the reagents shall be mutually agreed upon by the contractor and the Government through a bilateral modification.

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

1.9. CONTRACTOR PERSONNEL.

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

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

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

1.9.1.3. All contractor employees, minus maintenance, must be registered with the SYMPLR© system for access at WBAMC. With SYMPLR© access vendor representative will have a badge. Contractors must check in with SYMPLR© upon arrival to the facility and report to PMO to check in. There the contractor will have PMO escort the contractor personally or will contact the main laboratory to have an escort come down to receive them. All contracting personnel must be escorted at all times and will not be permitted on premises without an escort. SYMPLR© access will not be paid for by the government and access is by individual not by company.

1.9.1.4. Contractor maintenance personnel must check in with Medical Maintenance. Medical Maintenance will issue them a temporary badge and check them in. The Contractor will then be escorted by medical maintenance to the lab or medical maintenance will contact the main lab for the escort. At no time will Contractor Maintenance Personnel be without an escort in the WBAMC facility.

1.9.1.5. WBAMC Contractor Maintenance policy may change to the SYMPLR© system for login. The COR will notify the vendor when and if this happens. SYMPLR© access will not be paid for by the government and access is by individual not by company.

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, TJC, 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 WBAMC 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.

MAS

Minimum Acceptable Standards

PMS

Preventive Maintenance Services

PRS

Performance Requirements Summary

QC

SOW

Statement of Work

WBAMC

William Beaumont Army Medical Center

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

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

3.2. EQUIPMENT.

3.2.1. Vendor will supply a minimum of (2) two Automated Urinalysis analyzers for William Beaumont Army Medical Center, new hospital location. If the minimum required analyzers are not enough to meet the workload demands the vendor, an additional Urinalysis analyzer will be supplied by the vendor.

3.2.2. The contractor shall also provide (1) one Automated Urinalysis analyzer for the Mendoza Clinic (SFCC), FT Bliss.

3.3. MATERIALS. No materials will be provided.

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

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

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

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

4. CONTRACTOR FURNISHED PROPERTY

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

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

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

5. SPECIFIC TASKS

5.1. DESCRIPTION

5.1.1. The Contractor shall provide a fully automated system that includes: urinalysis analyzer systems capable of performing all of the required assays listed in Appendix 1 through continuous random access and/or stat operations and the ability to connect to the laboratory information system bi-directionally. The system shall provide redundancy (to ensure continuous operations), training, supplies, reagents, unscheduled maintenance, and preventive maintenance for the equipment. All equipment displays and supporting literature must be in the English language. Contractor shall include delivery, installation, all calibrators/standards, reagents/reagent packs, and quality control materials necessary to perform the specified assays, initial Method Validations per CLIA/NCCLS/DPALS QM guidelines and analyzer removal at the termination of the contract. All costs will be calculated on a cost per test based on the number of patients listed for each Mandatory Tests on Appendix 1. Costs shall be amortized over the total number of tests described in this SOW and factored into the cost per kit.

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

· All analyzers

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

· Uninterruptable Power Sources (UPS)

5.1.1.2. The analyzer systems will be located at:

William Beaumont Army Medical Center 18511 Highlander Medics St.

El Paso, TX 79918

5.1.1.3. Validation, Verification, and Correlation of equipment is not required location at WBAMC.

5.1.1.4. The contractor shall provide automated urinalysis capabilities to SFCC. Facility will be given a single, desktop analyzer in order to meet space restrictions. The analyzers must be capable of performing all of the required assays listed in Appendix 1 for each area. Contractor shall include delivery, installation, all calibrators/standards, reagents/reagent packs, and quality control materials necessary to perform the specified assays, initial Method Validations per CLIA/NCCLS/DPALS QM guidelines and analyzer removal at the termination of the contract.

5.1.1.5. The analyzer systems will be located at:

Mendoza Clinic (SFCC) 11335 SSG Sims St.

East Ft. Bliss, TX 79916

5.1.2.1. Validation, Verification, and Correlation of equipment is not required at WBAMC.

5.1.3. 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. The Laboratory is undergoing complete renovations so this is critical to ensure electrical, drainage, etc. needs are identified early. Additionally, the installation of equipment may need to be performed in a phase process at no additional cost to the government.

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

5.1.4.1. Method Validation will include but not be limited to, reference range verification, demonstration of linearity with limit of quantitation verification (LOQ), limit of detection verification (LOD), reportable range, correlation with current methods (comparison of methods study), validation of analytical measurement range (AMR), validation of clinical reportable range (CRR), validation of imprecision (within day and between day) and accuracy (recovery study), and establishment of initial control ranges using control materials, to include third party controls, as designated by the Laboratory Director.

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

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

5.1.4.3. All reagents, calibrators and linearity materials used in the Method Validation Study will be provided by the Contractor at no additional cost to the Government, to include third party reagents and controls as indicated by the Government and agreed upon by the Contractor. These materials will not be used in the analysis of specimens for patient care. When new tests or new Generations of reagents are available/added, the Contractor will be on-site or remotely assist with all necessary bi-annual validation studies and supply all necessary reagents, calibrators, linearity materials.

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

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

5.1.4.

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

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

5.1.5.2. Weekly and monthly maintenance shall require minimal user action.

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

· The hazardous material

· The specific hazard

· The required practices for the safe use of the product

· First aid procedures

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

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

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

5.2 WBAMC Main Hospital Laboratory. The contractor will provide fully automated, bi-directional urinalysis analyzers with: 1) Urine Chemistry testing; 2) Urine Sediment Microscopy/Morphology; 3) minimal significant effects from interfering substances; 4) Use of single aspiration needle for both open and close mode sampling.

The total number of analyzers shall be determined by the minimum throughput, available menu requirements, patient acuity and be able to continually operate for 12-hrs without having to stop to load reagents or consumables. See equipment minimum requirements paragraph 3.2 Equipment.

5.2.11 Minimum actual through-put shall be: 1) up to 80 full Urinalysis including sediment Microscopy per hour; 2) have an ideal minimum sample volume. 3) Be able to provide automated Quality Control.

5.2.12 Each analyzer shall be a continuous random access analyzer system with STAT prioritization capability.

5.2.13 Be able to recognize LIS generated bar-code labels (both code 39 and 128) on primary sample tubes.

5.2.14 Have an offering of stable reagents with beneficial shelf-life/storage stabilities for both opened and unopened containers.

5.2.15 Ability to interconnect multiple analyzers as one and used simultaneously as independent analyzers.

5.2.16 Specimen Storage: The analyzer needs to be able to analyze samples with limited flags or failures due to various conditions or substances such as turbidity, mucus, bloody samples.

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

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

5.2.19 Each analyzer system must come equipped with an un-interruptible power supply (UPS) capable of providing all necessary electrical power to each analyzer system for 15 to 20 minutes. The Contractor is responsible to ensure the UPS remains maintained and operable throughout the length of the contract. The power cord for the UPS must be a minimum of 11 foot in length for the WBAMC Main Hospital due to overhead ceilings outlets.

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

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

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

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

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

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

5.2.26 The Thin Client shall provide a dynamic interface with other analyzers that are not physically attached to the automation line. These analyzers may, or may not be from the same vendor. This interface at a minimum shall provide information as to the presence of specimens on the analyzer, and may act as a conduit for results management.

5.2.27 Remote diagnostics and troubleshooting shall be available using a maintenance application program that allows technical and service specialists at the Contractors technical support center or a field representative to remotely access the instruments to diagnose a problem.

5.2.28 The Contractor will provide a middleware solution and full IT support as defined below at no addition cost to the Government throughout the life of the contract. Middleware capabilities shall include, at a minimum, the following features:

5.2.29 The capability to write user defined auto-verification/auto-result validation rules that can hold transmission of results for review by the user.

5.2.30 The capability to validate user defined auto-verification/result validation rules.

5.2.31 Support patient delta checks as part of the auto-verification process.

5.2.32 Establish Moving Averages (Average of Normals) protocols to identify trends that may affect patient results.

5.2.33 Store patient results for a minimum of 12-months to facilitate auto-verification/auto-result.

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

5.2.35 The Contractor shall provide consumables, reagent containers, etc. in sufficient quantities and quality to perform these assays.

5.2.36 URINALYSIS ANALYZERS (Mendoza) - - The contractor shall must provide an individual fully automated, bi-directional urinalysis analyzer with: 1) Urine Chemistry testing; 2) Urine Sediment Microscopy/Morphology; 3) minimal significant effects from interfering substances; 4) Use of single aspiration needle for both open and close mode sampling. The total number of analyzers shall be determined by the minimum throughput, available menu requirements, patient acuity and be able to continually operate for 12-hrs without having to stop to load reagents or consumables. See equipment minimum requirements paragraph 3.2 Equipment.

5.2.37 Minimum actual through-put shall be: 1) up to 80 full Urinalysis including sediment Microscopy per hour; 2) have an ideal minimum sample volume. 3) Be able to provide automated Quality Control.

5.2.38 Each analyzer shall be a continuous random access analyzer system with STAT prioritization capability.

5.2.39 Be able to recognize LIS generated bar-code labels (both code 39 and 128) on primary sample tubes.

5.2.40 Have an offering of stable reagents with beneficial shelf-life/storage stabilities for both opened and unopened containers.

5.2.41 Ability to interconnect multiple analyzers as one and used simultaneously as independent analyzers.

5.2.42 Specimen Storage: The analyzer needs to be able to analyze samples with limited flags or failures due to various conditions or substances such as turbidity, mucus, bloody samples.

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

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

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

5.2.46 Each analyzer system must come equipped with an un-interruptible power supply (UPS) capable of providing all necessary electrical power to each analyzer system for 15 to 20 minutes. The Contractor is responsible to ensure the UPS remains maintained and operable throughout the length of the contract. The power cord for the UPS must be a minimum of 11 foot in length for the WBAMC Main Hospital due to overhead ceilings outlets.

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

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

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

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

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

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

5.2.53 The Thin Client shall provide a dynamic interface with other analyzers that are not physically attached to the automation line. These analyzers may, or may not be from the same vendor. This interface at a minimum shall provide information as to the presence of specimens on the analyzer, and may act as a conduit for results management.

5.2.54 Remote diagnostics and troubleshooting shall be available using a maintenance application program that allows technical and service specialists at the Contractors technical support center or a field representative to remotely access the instruments to diagnose a problem.

5.2.55 The Contractor will provide a middleware solution and full IT support as defined below at no addition cost to the Government throughout the life of the contract. Middleware capabilities shall include, at a minimum, the following features:

5.2.56 The capability to write user defined auto-verification/auto-result validation rules that can hold transmission of results for review by the user.

5.2.57 The capability to validate user defined auto-verification/result validation rules.

5.2.58 Support patient delta checks as part of the auto-verification process.

5.2.59 Establish Moving Averages (Average of Normals) protocols to identify trends that may affect patient results.

5.2.60 Store patient results for a minimum of 12-months to facilitate auto-verification/auto-result.

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

5.2.62 The Contractor shall provide consumables, reagent containers, etc. in sufficient quantities and quality to perform these assays.

5.3. REAGENTS.

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

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

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

5.3.4. The analyzer shall be capable of maintaining calibrations for all of the assays listed in Appendix 1 simultaneously.

5.3.5. The assays listed in Appendix 1 shall be available for processing on the analyzer at all times.

5.3.6. Reagents shall have a minimum shelf life of three (3) months upon receipt by the Government, or, if this shelf life requirement cannot be met, the Contractor shall (must) identify the guaranteed shelf life after receipt that can be accommodated in their response to the Request for Proposal.

5.3.7. Controls will have shelf life of 4-12 weeks.

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

5.3.9. All test kits will be provided as follows:

5.3.9.1. Inclusive of an English language package inserts.

5.3.9.2. Be provided by the manufacturer of the equipment.

5.3.9.3. Delivered on time (see 5.3.10.3.1), at the appropriate storage temperature, and marked with any required temperature controls as necessary.

5.3.9.3.1. Routine or scheduled orders will arrive within one week before or after the scheduled date of delivery.

5.3.9.3.2. Emergency orders will be delivered within 24 hours after the order is placed.

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

5.3.9.5. 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.

5.3.9.6. The Contractor shall provide the reagents as outlined in the Schedule of Supplies/Services. Delivery of the reagents will be as scheduled/required by the individual delivery orders issued by the contracting officer.

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

5.3.9.8. The Contractor shall provide quality control materials sufficient to run every 8-hours and to be used as needed for troubleshooting. This includes third-party controls where requested/required by the laboratory. These controls and calibrators should be at no cost to the government.

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

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

5.3.9.11. 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/ parts kit will be provided and replenishment of all expended items will be made by the contractor, at no additional cost to the Government. Replenishment shall be made as needed or on a periodic basis not to exceed the normal preventive maintenance cycle.

5.3.10. Calibration frequency for all assays shall not be less than twice a year (every 6 months) under routine operations. This calibration frequency does not include calibrations required following instrument repair or servicing (e.g., field service type maintenance or service, major changed in instrument components that affect readout, QC troubleshooting, etc.) or other instances as described in the Laboratory QA Program or approved by the Laboratory Director.

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

5.3.11.1. Be provided by the manufacturer of the equipment.

5.3.11.2. Be marked with the required storage temperature.

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

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

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

5.3.13. Deliveries.

5.3.14. Deliveries of required items shall be per monthly standing orders as agreed upon between the Contractor and the Government. The Contractor needs to specify the last date that a standing order can be modified for a single delivery and/or all subsequent orders. Orders shall arrive on the date agreed upon and if the scheduled date is a Federal Holiday (listed above), the delivery will be scheduled for the day following the Federal Holiday. Any supplies that are placed on back order shall be clearly identified on the shipping documents and shall be delivered in a timely manner, not to exceed ten (10) working days. In the instance a back-order exceeds 10 working days, the Contractor shall provide testing services through local sub-contract at their cost.

5.3.14.1. Emergency orders shall be delivered within 24 hours after the order is placed and be of the same lot number of calibrators/standards, reagents/reagent packs, or quality control materials currently in use for the assay(s) for which supplies are being requested. Contractor will notify the Government via email and telephonic message when an order is not available or capable to be shipped within these timelines.

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

5.3.14.3. Preservation and packing - Preservation and packing shall be performed in accordance with the best commercial practice and in such a manner to afford adequate protection against any damage during shipment from source to destination. All packaging and shipping information shall be clearly marked as to contents on both the shipping documents and the shipping container/box. All deliveries will be made Tuesday through Thursday, to exclude Federal Holidays.

5.4. ANCILLARY MAINTENANCE AND SERVICE

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

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

5.4.1.2. The Contractor shall provide all personnel, equipment, tools, materials, supervision, parts, transportation, and other items and services necessary to perform all required repairs and scheduled preventive maintenance/safety inspections and calibrations of equipment. The performance of scheduled periodic preventive maintenance, safety checks, and calibrations that are not normally performed at the operator level shall be performed by Contractor service personnel in accordance with requirements as specified in the Contractor’s instrument maintenance manual. The Contractor shall provide routine calibration services for those calibration procedures that are outside the scope of user responsibility. Completion of installation of the analyzers will establish time zero for determination of time frames for performance of the above periodic services.

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

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

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

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

5.4.2.3. All work shall be performed in a professional manner by an authorized service representative. If any deficiencies are found due to negligence of the service technician, the Contractor shall be required to correct the deficiency to a fully operational status in accordance with manufacturer specifications at no additional cost to the Government.

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

5.4.2.4. Preventive maintenance services shall be performed in accordance with the manufacturer’s standards/procedures. A preventive maintenance service shall include, but is not limited to, safety, calibration, complete operational testing, lubrication, adjustments, and cleaning of equipment to which the operator does not have access. This also includes the installation of all non-operator parts required to ensure proper operation.

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

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

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

5.4.2.7. Within 2 business days after completion of a repair, the Contractor’s service technician shall furnish via email the COR one (1) copy of a service report for all services performed with a copy to the Equipment Management Branch and the Laboratory Representative for the MTF. The report shall be in English and shall contain, as a minimum, the following information:

· Nomenclature and serial number

· Date

· Description of services performed (i.e., preventive maintenance service, or unscheduled repair service)

· Location of services performed

· Duration of performance (hours)

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

· Name of technician

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

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

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

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

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

5.4.3. SERVICE:

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

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

5.4.3.3. The Contractor shall provide a full unscheduled and PMS throughout the contract. PMS shall be at no additional cost to the Government inclusive of all costs for the performance of scheduled periodic maintenance (as required by the Contractor’s instrument maintenance manuals), unscheduled maintenance and repair of the analyzers and any associated equipment provided by the Contractor as part of the analyzer system, including replacement parts, replacement part shipment costs, and service technician travel costs for performance of maintenance services.

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

5.4.3.5. The Contractor’s qualified service technician shall be on site to provide routine services; service requiring immediate repair; and one (1), two (2) or four (4) scheduled services for preventive…