Statement_of_Objectives_Jun_29.pdf

W81K0018Q0046 Urinalysis Analyzers

STATEMENT OF OBJECTIVES

The successful offeror shall furnish all equipment, reagents, consumables, controls, and any necessary services (e.g. maintenance of furnished equipment) to the Brooke Army Medical

Center, Fort Sam Houston, Texas for the purpose of Urinalysis testing under a Cost-Per-

Reportable (CPR) Agreement. All equipment and reagents/ consumables shall be supplied and serviced through the Contractor to include all parts, equipment, supplies, and other services required to ensure BAMC is able to meet its objectives as listed herein.

This requirement should include training, supplies, reagents, unscheduled maintenance for the equipment and telephonic assistance for three (3) fully automated desktop machines and six (6) semi-automated desktop machines. Contractor shall include delivery, installation, all calibrators/standards, reagents/reagent packs, and quality control materials necessary to perform the initial method validation per CLIA/ NCCLS QM guidelines and analyzer removal at the termination of the contract.

Period of Performance:

Base: 1 October 2018 – 30 September 2019

Option 1: 1 October 2019 – 30 September 2020

Option 2: 1 October 2020 – 30 September 2021

Option 3: 1 October 2021 – 30 September 2022

Option 4: 1 October 2022 – 30 September 2023

Sub-factor 1. Instruments/Equipment and Reagents/Consumables

1.1 ANALYZER PERFORMANCE OBJECTIVES

1.1.2 The contractor must provide the following at a minimum for operations at the BAMC laboratory.

1.2.2 The analyzer systems must be capable of interfacing with the laboratory’s Laboratory

Information System (LIS) Composite Health Care System (CHCS). The contractor must have an established driver compatible for interfacing with CHCS. The interface between CHCS and the analyzers must be bi-directional.

1.1.3 The analyzers system must include a data management system for control of the operation of the analyzer systems, 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.

1.1.4 N/A.

1.1.5 A description of the records to be kept to document inspections and corrective 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.

1.1.6 N/A.

1.1.7 N/A.

1.1.8 The analyzer systems must come equipped with an un-interrupted power supply capable of providing all necessary electrical power to all components of the urinalysis system for a minimum of thirty (30) minutes.

1.1.9 N/A.

1.1.10 The analyzer systems shall have the ability to test multiple analytes from a single tube.

1.1.11 Lab Layout: The offeror shall provide a diagram or other graphical representation demonstrating how its proposed equipment fits within the dimensions in Appendix 2 Current

Configuration with its submission.

1.1.12 Individual fully automated analyzers shall have fully automated, discrete random access capabilities within the same instrument.

1.1.13 For fully automated analyzers, there shall (must) be a single point of specimen entry for the routine analysis of all required tests. There shall (must) be an optional separate specimen point of entry for STAT specimens.

1.1.14 The instruments provided will be capable of the following:

• Instrument with throughput not less than 50 complete urinalysis including microscopic per hour.

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

• Recognize CHCS generated bar-code labels on primary sample tubes.

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

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

1.1.16 Minimum actual through-put shall be 50 complete urinalysis with microscopic examination per hour.

1.1.17 All analyzer/data management system displays and supporting literature shall be in the

English language.

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

1.1.19 N/A.

1.1.20 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.

1.1.21 The analyzer shall (must) have the on-board ability to maintain reagents at the proper storage temperatures for the assays listed in Appendix 1 Mandatory Tests and Estimated

Patients per year. All assays must be FDA approved.

1.2. REAGENT PERFORMANCE OBJECTIVES

Table - Required Microscopic/Chemistry Analyte tests

1.2.0 The Table above identifies the Urine chemistry analyte tests and the Urine microscopic analyte tests that shall run on the analyzers. The analyzers must be able to perform all the analyte tests identified in the Table. These analytes are all required to be ran on each run of a single sample.

1.2.1 The analyzer must have the ability to maintain reagents on-board at the proper storage temperature.

1.2.2 Reagents/consumables must meet the requirements of the BAMC mission, workload and test menu outlined in Appendix 1 Mandatory Tests and Estimated Patients per Year.

1.2.3 The tests must be approved by the FDA.

1.2.4 Reagents must have a shelf life of at least six (6) months.

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

The reagents/ reagent packs will be provided as follows:

1.2.6 Be provided by the manufacturer of the equipment.

1.2.7 Be marked with the required storage temperature.

1.2.8 Reagents must be shipped in a manner that will preserve the proper storage temperature during transportation and be delivered on time at the appropriate storage temperature.

1.2.9 The contractor shall provide the reagents/reagent packs, calibrators/standards, user-replaceable maintenance items and analyzer specific tools/supplies.

1.2.10 Emergency orders will be delivered within 24 hours after the order is placed by 1400

Monday through Thursday.

1.2.11 The Government retains the right to modify the quantity of each reagent/reagent pack based on changing patient population and test requests.

1.2.12 All reagents shall be FDA-approved and should exhibit at least 90% sensitivity and 90% specificity.

1.2.13 Reagents used for troubleshooting analytical systems shall be reimbursed (or replaced) by the Contractor at no additional cost.

1.2.14 Delivery of the reagents will be on an “As Needed” basis by the individual delivery orders issued by the contracting officer. The Contracting Office or their representative shall be the only entity authorized to issue orders against the resulting contract.

1.2.15 Delivery of reagents will not exceed 7 calendar days from the date of request.

1.2.16 The contractor shall be responsible for the collection and transportation of equipment upon termination of the contract. This shall be performed within fourteen days of contract completion.

1.2.17 Contractor shall provide Safety Data Sheets (SDS) for each item delivered under this contract that is considered to be HAZARDOUS MATERIAL by the United States. The SDS shall contain information on the hazards associated with each specific chemical or material. The SDS shall contain, as a minimum, the following information: identification of the hazardous material and the specific hazard, the required practices for the safe use of the product, first aid precautions and what to do in the event of a spill or other mishap or accident.

1.2.18 N/A.

1.2.19 The workload listed in Appendix 1 Mandatory Tests and Estimated Patients per year 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.

1.2.20 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 i n correcting equipment operation problems.

1.2.21 Maintenance services shall be performed in accordance with the manufacturer's standards/procedures. 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.

1.2.22 The contractor shall notify the Point of Contact of the exact date and time for maintenance at least two (2) days prior to the scheduled maintenance.

1.2.23 The contractor's qualified service technician shall be onsite to provide routine services, service requiring immediate repair and one (1), two (2) or four (4) scheduled services for maintenance (as specified i n the Contractor's instrument maintenance manual), safety and calibration as required by this performance based work statement. The contractor will take every reasonable action to have the equipment repaired and operational within 48 hours after initial response by the contractor.

1.2.24 The Contractor shall perform routine repair service between 8:00 AM and 4:15 PM

Monday through Friday, excluding Federal Holidays. Contractor response time shall be within

48 clock hours after telephonic notification excluding weekends and Federal Holidays.

1.2.25 Repair completion time for a routine repair service shall not be more than 96 clock hours after telephonic notification excluding weekends and Federal Holidays.

1.2.26 Upon analyzer failure between 0730-1630 Monday-Fridays, the Contractor's qualified service technician shall be on-site to provide unlimited emergency service (service requiring immediate repair; an unscheduled maintenance/service requirement) within 24 hours.

1.2.27 Should the analyzers at BAMC become inoperable, the Contractor's technical repair specialist should be on-site within eight (8) hours of initial notification and the repair of the analyzer completed within one (1) working day of initial notification. If deemed necessary after consultation with the contractor, if analyzer cannot be repaired within one (1) working day of the initial notification, contractor will work with BAMC for determining the identification of alternative sources of testing. The Contractor will pay all costs associated with the provision of this service, for as long as the analyzer remains inoperable.

1.2.28 If the equipment is determined to be out of service for longer than 48 hours (from the time of service technician's arrival on the site), the contractor shall notify the Lab Manager as to the reason(s) (i.e. non- availability of parts, etc.) for non-operability.

1.2.29 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 maintenance tasks, at no additional cost to the Government.

Sub-factor 2. Maintenance/Service

2. MAINTENANCE AND SERVICE:

2.1.0 Maintenance services on leased analyzers are at no additional cost to the Government.

These services are done by the vendor to ensure its equipment is fully operational and in compliance with FDA requirements for use. These are not services provided on Government owned equipment.

2.1.1 At the start of the contract, the Contractor shall have a contract representative and alternate responsible for scheduling and coordination of service calls. The name and phone number of the designated individual and alternate shall be provided to the Chief, Medical

Maintenance Branch.

2.1.2 Contractor shall deliver all new equipment to the Property Management Section at the beginning of the contract. Clinical Engineering Section will perform acceptance inspection and establish maintenance records for equipment. These records will be maintained for the duration of the contract period. Clinical Engineering will maintain historical data that shows the acceptance inspection and services performed on the equipment by Medical Maintenance and/or the MFG as long as the equipment is in the Government Facility.

2.1.3 Any and all equipment contracts to include, lease, cost per test, loan, etc., must be reviewed and approved by the Chief, Clinical Engineering and reviewed by the PBO for purposes of maintenance and accountability, whether accomplished by in-house maintenance or contract personnel.

2.1.4 The BAMC Medical Maintenance Branch will first evaluate any equipment malfunction and facilitate repairs (screening process). If a service call is necessary, the Contractor shall provide unlimited service calls. Only the Medical Maintenance Branch will determine if the required repair service is emergency or routine.

2.1.5 The contractor shall be responsible for furnishing maintenance, services, repairs and parts as required in order to maintain the system is operating in the proper working condition in accordance with the Original Equipment Manufacture’s (OEM) specifications.

2.1.6 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.

2.1.7 The contractor shall provide a full unscheduled maintenance service for the performance period at no additional cost. Service shall include repair and replacement of defective parts, complete maintenance program (as required by the manufacturer's manuals), and hotline telephone service to assist operators in troubleshooting problems.

2.2 REPAIR:

2.2.1 Upon notification of equipment failure, the Contractor shall respond to telephonic requests for unscheduled repair within one (1) working day. Should the analyzer become inoperable, the

Contractor’s technical specialist must be on-site within eight (8) hours of initial notification.

2.2.2 All work shall be performed in a professional manner by an authorized service representative who should have two (2) years of maintenance experience on the contracted equipment. 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.

2.2.3 Contractor shall respond within 48-hours, during normal duty hours of 8:00 AM and 4:00

PM excluding Federal Holidays.

FEDERAL HOLIDAYS:

New Year’s Day, January 1

Martin Luther King's Birthday, 3rd Monday in January

Washington's Birthday, 3rd Monday in February

Memorial Day, last Monday in May

Independence Day, July 4

Labor Day, 1st Monday in September

Columbus Day, 2nd Monday in October

Veteran's Day, November 11

Thanksgiving Day, 4th Thursday in November

Christmas Day, December 25

2.2.4 The government and the contractor’s service representative shall exchange any hazard communication information before the commencement of any repair.

2.2.5 When required, the contractor’s service representative will comply with the Office of

Safety and Health Administration lockout/tag out standards while performing maintenance on equipment.

2.2.6 Upon completion of services by the contractor’s service representative, a written service report shall be provided to the maintenance manager or the AOD. The service report shall provide detailed information regarding the cause of the equipment malfunction and corrective action taken. Include, at a minimum, 1) the time required to complete the work 2) price of labor

(hourly rate) 3) list of parts replaced with part numbers and prices for each part 4) Nomenclature and Serial Number 5) Date 6) Name of the Technician.

2.2.7 In the event all information is not available to the contractor's service representative when services are performed, the initial service report shall include all available information. The contractor shall provide the balance of the required information to the maintenance manager no later than 10 days after services are completed.

2.2.8 In the event of calibration, after performing Calibration/Verification/Certification services, the contractor’s service representative will affix and/or update DD Form 2163 (Medical

Equipment Verification/Certification). The contractor shall complete DD Form 2163 in accordance with the instructions provided in Technical Bulletin (TB) 38-750-2, or by the maintenance activity’s internal SOP.

2.2.9 If the contractor's calibration equipment produces a printed summary of the calibration procedure used, attach the printed summary to the DD Form 2164. Ensure that the heading of the DD Form 2164 is filled out and that the form is properly signed.

2.2.10 Contractor’s service representative will be factory trained and have a minimum of two years of experience working on the contracted equipment.

2.3 SERVICE

2.3.1 The Medical Maintenance Branch will first evaluate any equipment malfunction and facilitate repairs (screening process). If a service call is necessary, the Contractor shall provide unlimited service calls. Only the Medical Maintenance Branch will determine if the required repair service is emergency or routine.

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

2.3.3 Method Validation will be conducted in accordance with method validation protocols established by the Department of Pathology’s Quality Management Program (these protocols are in concordance with applicable standards as described by the Clinical Laboratory Standards

Institute (CLSI) and/or required by the College of American Pathologists (CAP)). Relevant guidelines listed in Appendix 2 Current Configuration (below Paragraph 4 and after Appendix 1) are the minimum guidelines that will be referenced when conducting method validation.

Additional guidelines may be required, depending on regulatory requirements.

2.3.4 Method Validation will include but not be limited to, normal range verification, demonstration of linearity, reportable range, correlation with current methods (comparison of methods study), validation of analytical measurement range (AMR), validation of precision

(replication study) and accuracy (recovery study), and establishment of initial control ranges using control materials, to include third party controls, as designated by the Laboratory Director.

2.3.5 The Method Validation will be completed, reviewed, and approved by the Section 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.

2.3.6 The Contractor shall provide a qualified Technical Service Representative, who possesses a thorough knowledge of method validation and is familiar with the use of statistical evaluation software as determined by the Laboratory Director (e.g. EP Evaluator®), to provide technical assistance for the method validation studies. The assigned Technical Service Representative will be responsible for the entire Method Validation and establish appropriate reporting parameters for each reportable result consistent with BAMC patient population and existing reporting criteria. In addition, periodically required to evaluate percent Microscopics required for goal of <=30% Microscopics required.

2.3.7 All reagents, calibrators and linearity materials used in the Method Validation Studies 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.

2.3.8 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.

2.3.9 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.

2.3.10 The Contractor shall provide two (2) paper and two (2) 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.

2.3.11 The Contractor shall provide safety data sheets (SDS) for each item delivered under this contract that is considered to be HAZARDOUS MATERIAL by the United States or the

Contractor’s representative Government. The SDS shall contain information on the hazards associated with each specific chemical or material and meet all regulatory agency (e.g., CAP, TJC, etc.) requirements. The MSDS shall be printed in the English language and shall contain, as a minimum, identification of:

- The hazardous material

- The specific hazard

- The required practices for the safe use of the product

- First aid procedures

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

2.3.12 The Contractor shall provide a water system (e.g. filtered, deionized etc.), if required by the analyzer, that shall provide uninterrupted service for a period of time to be determined by the Laboratory Medical Director.

2.3.13 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).

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

Sub-factor 3. Delivery/Installation

3. Delivery/Installation

3. The Analyzers shall (must) be delivered to the location as indicated below within 30 calendar days after contract award. Equipment setup, on-site training, method validation studies, and analytical measurement range/linearity verification, shall (must) be completed by Contractor personnel within a period of time to ensure that equipment is fully operational on or before

September 30, 2018. During the initial implementation, a dedicated technical representative must be available on site throughout the entire implementation period and at go-live.

Substitutions must be coordinated with the COR.

Offerors shall provide milestones with their submissions depicting significant events from time of contract award to the "Go Live Date".

The system shall be delivered and installed at:

Brooke Army Medical Center –Core Chemistry Lab (4th floor)

3551 Roger Brooke Drive

San Antonio, Texas 78234

Core Chemistry: one fully automated desktop machine and one semi‐automated desktop machine (back‐up).

Emergency Department STAT Lab (1st floor)

3551 Roger Brooke Drive

San Antonio, Texas 78234

Emergency Lab: one fully automated desktop machine and one semi‐automated desktop machine (back‐up).

CPT Jennifer M. Moreno Primary Care Clinic

3100 Schofield Road

Fort Sam Houston, Texas 78234

Moreno Clinic: one fully automated desktop machine and one semi‐automated desktop machine (back‐up).

Schertz Medical Home

6051 FM 3009, Suite 210

Schertz, Texas 78154

Schertz Medical Home: one semi‐automated desktop machine

SPC Taylor J. Burke Clinic

5026 Camp Bullis Road

Camp Bullis, Texas 78257

Camp Bullis Clinic: one semi‐automated desktop machine

Westover Medical Home

10010 Rogers Crossing

San Antonio, Texas 78251

Westover Clinic: one semi‐automated desktop machine

Sub-factor 4. Training

4. TRAINING:

4.1.1 The Contractor shall provide initial on-site operator training to all technicians assigned to the Government site (i.e., BAMC Dept of Pathology Laboratory staff) prior to initiation of use of the analyzer for patient testing. In addition, the Contractor shall provide training for two (2) primary operators, per analyzer at the Contractor’s training site, prior to delivery and installation of the analyzer.

4.1.2 The on-site operator training shall be provided by qualified Contractor trained personnel using Contractor owned instrumentation in a mobile environment. The training shall encompass basic operation, maintenance and troubleshooting.

4.1.3 The Contractor shall provide two training slots per analyzer per contract year, at the

Contractor’s training site, at no additional cost (including transportation airfare, rental car, etc.)

to the Government.

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

4.1.5 The on-site operator training shall be provided by qualified Contractor-trained personnel using Contractor owned instrumentation in a mobile environment. The training shall encompass basic operation, maintenance and advanced troubleshooting.

4.1.6 All training manuals/guides, instructional literature, and any other related written/electronic material shall be in the English language. Training shall include basic operation of the analyzers, troubleshooting procedures, performance of operator-level maintenance procedures, and use of the data management/quality control software.

Appendix 1

Mandatory Tests and Estimated Patients/Year

Appendix 2 (current configurations)

Chemistry Moreno

ED Stat Lab Schertz

Camp Bullis Westover

Water Source Distance: 3 feet

Electricity Distance: 1 foot

Electricity Distance: 1 foot Electricity Distance: 1 foot Electricity Distance: 1 foot

Water Drainage Distance: 6 feet

Water Drainage Distance: 8 feet

Electricity Distance: 1 foot Electricity Distance: 1 foot

Electricity Distance: 1 foot

Water Drainage Distance: 10 feetWater Drainage Distance: 20 feet

Water Drainage Distance: 24 feet

Electricity Distance: 1 foot

Water Source Distance: 6 feet

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