ATCH 1 - Statement of Work Automated Urinalysis System Revised 20May2024.pdf

STATEMENT OF WORK

FOR

David Grant Medical

Center

(DGMC)

Cost Per Reportable (CPR) Automated Urinalysis System

Revised: 20 May 2024

TABLE OF CONTENTS

Section

1. Description of Services

2. General Information

3. Available Services

4. Technical Requirements

5. Definitions/Acronyms/Publications/HIPAA

6. Attachments/Technical Exhibit Listing

7. Fac i l i ty Modi f i ca t ions

8. DHA Medical Device Equipment Cybersecurity/Risk Management Framework

Requirements

PART 1

1.0 DESCRIPTION OF SERVICES

1.1. Description of Services: David Grant Medical Center requires a fully automated urinalysis system, to include both a urine chemistry analyzer and urine particle analyzer, that is capable of performing all of its necessary urinalysis testing assays. The analyzer must provide digital image analysis with minimal to no need for manual urine sediment microscopy.

1.2 Scope: The Contractor shall provide all management, tools, parts, materials (including all reagents, quality control materials, and consumable parts and accessories), equipment, travel, and labor necessary to provide the instrumentation described in Part 4 for the Clinical Lab located at David Grant Medical Center, Travis AFB. In addition, the Contractor shall include all site preparation, construction, extended installation, incidental services, labor, shipping, supplies, materials the Contractor will be responsible for to provide a fully operational turn-key system, meeting all minimum requirements and essential characteristics for each respective analyzer per the Statement of Work. Services include instrument use, preventive maintenance, troubleshooting guidance, 24/7 telephone service as well as response by a technical expert provided by the contractor 7 days per week from 0000 to 2359, including Federal Holidays and calibration services, not included in routine maintenance, at frequencies specified in the manufacturer’s service and operations manuals, and any required intervening repair service requirements for the entire contract period, including options if exercised. Expedited shipping options, to include overnight, should emergent supply needs arise. All patient and testing information must be accessible and accurate. All services provided shall be performed in accordance with all applicable laws, regulations, standards, local instructions, and commercial practices. All components outlined in this SOW, to include analyzers, associated peripherals, and data management systems will be serviced and supplied through a single Contractor (to whom the contract is awarded), including any parts, equipment, or supplies not manufactured, provided, or serviced by the Contractor.

1.3 Objectives:

1.3.1 Must provide a fully automated urinalysis system, allowing for all urinalysis testing to be performed using one single stand-alone system. System must include a digital image analysis platform, capable of capturing high-quality urine particle images for operator classification.

1.3.2 Must be capable of performing all required Urinalysis testing assays outlined in Part 6, Attachment 2 of this SOW. All testing provided will be FDA approved for use.

1.3.3 Must have a current Authorization to Operate (ATO) for networked information technology to receive, process, store, display, or transmit Defense Health Agency (DHA) information or be in the process of attaining ATO. All aspects of the contractor’s system, to include both the analyzer itself and any associated components, software, and hardware, must have a current ATO authorization or be in the process of attaining ATO. The vendor is required to maintain ATO authorization for all aspects of the provided system for the entire duration of the contract.

1.3.4 Must be compatible with Military Health System and the Genesis Electronic Healthcare Record Platform.

1.3.5 Test performance and results will be 24/7 with no downtime.

1.3.6 All periodic preventive maintenance specified as not performed by end-user is upkept by the contractor and always performed within its recommended timeframe.

1.3.7 Performance of preventive maintenance, calibration, and quality will not render the department incapable of performing or resulting any testing.

1.3.8 Testing must be provided in a Cost Per Reportable (CPR) billing format.

1.4 Period of Performance (PoP): Base Year (12 Months) and four (4) (12 Months) option periods

PART 2

2.0 GENERAL INFORMATION

2.1 Contractor Identification

2.1.1 Contractor personnel performing services in a contractor capacity in a government facility are required to possess and wear an identification badge that displays his or her name and the name of their company.

2.1.2 Contractor personnel will be required to attend meetings or otherwise communicate with Government and/or other contract representatives to meet the requirements of this order. Contractor personnel shall make their contractor status known during introductions.

2.1.3 Contractor personnel, while performing in a contractor capacity, are prohibited from using their retired or reserve component military rank or title in any written or verbal communications associated with the contracts in which they provide services.

2.2 Place of Performance: The work shall be performed at David Grant Medical Center, Travis AFB.

2.3 Mission/Emergency Essential. The services outlined in this SOW are considered mission/ emergency essential. Inability to secure services on a timely manner can preclude use of medical equipment, cause compliance violations, and impair the provision of patient care.

2.4 Hours of Operation: Urinalysis Services are 24/7, 365 days a year to include Federal Holidays.

2.5 Recognized Federal Holidays:

New Year’s Day Labor Day Martin Luther King Jr.’s Birthday Columbus Day President’s Day Veteran’s Day Memorial Day Thanksgiving Day Juneteenth Day Christmas Day Independence Day

2.6 Contractor Communication

2.6.1 Government’s COR: The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions: assure that the contractor performs the technical requirements of the contract; perform inspections necessary in connection with contract performance; maintain written and oral communications with the contractor concerning technical aspects of the contract; issue written interpretations of technical requirements, including Government drawings, designs, specifications; monitor contractor's performance and notifies both the CO and contractor of any deficiencies; and provide site entry of contractor personnel. The COR is not authorized to change any of the terms and conditions of the resulting contract.

2.6.2 Post award conference/periodic progress meetings: The contractor agrees to attend any post award conference. At these meetings the CO will apprise the contractor of how the government views the contractor's performance and the contractor will apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues.

2.7 Safety: The Contractor will ensure that its staff conduct operations in a matter that meets industry OSHA safety standards for the protection of DoD staff, patients, and public. The Contractor is responsible for unsafe conditions associated with the actions of its personnel.

2.8 Quality:

2.8.1 Quality Control (QC): The contractor shall develop and maintain an effective QC program to ensure services are performed in accordance with this SOW. The contractor shall develop and implement procedures to identify, prevent, and ensure nonrecurrence of defective services. The contractor’s QC program is the means by which the work complies with stated requirements. The contractor’s QCP must be delivered to the CO within 30 days after contract is awarded. After acceptance of the Quality Control Plan (QCP) the contractor shall receive the CO’s acceptance in writing of any proposed change to his QC system. See Part 6, Attachment 3 - CDRL A001.

2.8.2 Quality assurance (QA): The government will evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan provides a systematic method for the Government to evaluate performance and to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

2.9 Delivery: Delivery instruction will be determined after award. Contractor at a minimum must be able to deliver within 30 days after award.

PART 3

3.0 AVAILABLE SERVICES

3.1 Services: The Government will provide the following services below:

3.1.1 Security Forces and Fire Protection: Phone numbers: Non-Emergency Fire Department: 424-3683;

Non-Emergency Security Police: 424-3293. Emergencies (call) 911.

3.1.2 Emergency Healthcare. The MTF will provide emergency health care to save loss of life or limb and preserve undue suffering for contract personnel for injuries or illness occurring while on duty in the MTF.

These services will be billed to the contractor at the current full reimbursement rate through TRICARE.

3.1.3 The space designated for the equipment and supplies will be provided at the Clinical Lab located at David Grant Medical Center, Travis AFB.

3.1.4 The government will furnish all required utilities such as water, telephone, electricity, etc. Long distance and Defense Switched Network (DSN) telephone services will be provided for official use only.

PART 4

4.0 TECHNICAL REQUIREMENTS

4.1 Instrumentation: Contractor shall provide a fully automated Urinalysis system that will meet all the requirements below. The urinalysis system will provide urine chemistry, urine particle counting, and digital imaging capabilities.

4.1.1 All tests must be FDA approved.

4.1.2 System will allow for testing of the following:

4.1.2.1 The urine chemistry module will perform the following testing: Bilirubin, Blood, Clarity, Color, Glucose, Ketone, Leukocyte Esterase, Nitrite, pH, Protein, Specific Gravity, and Urobilinogen.

4.1.2.2 The urine particle counter will provide either a quantitative or semi-quantitative measurement for the following parameters: Bacteria, Epithelial Cells, Hyaline Casts, Red Blood Cells (RBCs), and White Blood Cells (WBCs).

4.1.2.3 The system will be capable of detecting the following:

4.1.2.3.1 Urine Crystals to include Bilirubin Crystals, Cholesterol Crystals, Cystine Crystals, Leucine Crystals, Tyrosine Crystals, Calcium Oxalate Crystals, Triple Phosphate Crystals, Calcium Carbonate Crystals, Calcium Phosphate Crystals, Ammonium Biurate Crystals, Struvite Crystals, and Uric Acid Crystals.

4.1.2.3.2 Both cellular and acellular casts to include Granular Casts, Hyaline Casts, WBC Casts, RBC Casts, Fatty Casts, Epithelial Cell Casts, and Waxy Casts.

4.1.2.3.3 Sperm

4.1.2.3.4 Both Hyphenated and Budding yeast.

4.1.2.3.5 Mucus

4.1.2.3.6 Parasites, to include Trichomonas Vaginalis, Enterobius Vermicularis, and Schistosoma Haematobium.

4.1.3 Instrument shall be capable of completing testing using 5 mL of specimen in automated mode and 2 mL of specimen in manual mode.

4.1.4 Must be able to result at least 50 tests per hour.

4.1.5 Instrument must provide true walk-away final results without operator re- classification or photo image review required at the instrument for standardization.

4.1.6 Must utilize flow cytometry methodology or digital flow morphology.

4.1.7 The system will operate on a single automated line, which will incorporate all modules and analyzers included within the urinalysis system.

4.1.7.1 The system will operate through a single point of specimen management.

4.1.8 The system will have a mechanism to dissipate amorphous material.

4.1.9 The system will have a mechanism to prevent strip jamming.

4.1.10. Must have the following additional features:

4.1.10.1 Built-in barcode scanner

4.1.10.2 Traditional QC with target values assigned to QC materials.

4.1.10.3 Numeric or pass/fail QC.

4.1.10.4 Stops patient testing if QC fails or expires.

4.1.10.5 Abnormal and critical ranges flag the operator.

4.1.10.6 Canned or free text user comments.

4.1.10.7 Accepts patient ID or accession number.

4.1.10.8 Automated Check for low sample level using built-in liquid-level sensing.

4.1.10.9 Auto-Check for humidity exposure

4.1.11 The Urinalysis system will not introduce any contaminants to urine specimens ran through it.

Urine specimens, following performance on the contractor’s urinalysis system, will be usable for further testing outside the system.

4.2 Operator Training: Contractor shall provide initial and recurring training to technicians on instrument use, maintenance, and troubleshooting. Initial training will be provided to all technicians in person on-site by a representative. Recurring training shall include a web-based training program available on demand, and quarterly onsite training. The cost of all training, training materials, transportation, lodging, and meals for onsite representatives shall be included in the contract. The web-based training program must allow for an unlimited number of trainees to have personalized training plans that are accessed and tracked online. Web- based training shall include instructions for operation and maintenance of all included equipment. At least quarterly, the contractor will coordinate with the FRED and provide a representative to provide hands-on analyzer training to conduct onsite training for one day. Contractor shall provide comprehensive written operating instructions for all aspects of equipment functions (i.e.

routine specimen analysis, calibrations, etc.) and training materials to DGMC equipment operators on the daily, weekly, monthly, and as required maintenance when required or requested by the laboratory staff.

The service technician must be able to provide additional training in person as needed.

4.3 Instrument Installation and Validation: The contractor will install, validate, and correlate analyzers per College of American Pathologist guidelines with results approved by Laboratory Medical Director and

Chemistry Technical Supervisor. Contractor shall set up and validate custom auto-verification rules in middleware based on DGMC laboratory specific requirements. Contractor also provides all validation reagent, calibrators, controls, and consumables needed to perform these tasks during the validation period.

Any mutual agreed timelines will be documented and signed by Contractor (as designated via Section 1 of this SOW) and CO.

4.4 Initial Inspection: All contractor owned equipment will be inspected and approved by the Biomedical Equipment Maintenance Section prior to use in the Medical Treatment Facility. Contact Program Manager to schedule inspection.

4.5 Shipping Options and Supplies:

4.5.1 The contractor will provide expedited shipping options, to include overnight or next day, should emergent needs arise for any supplies provided by the contractor. If supplies for emergent needs are ordered prior to overnight shipping cutoff it is expected that item will arrive within 24 hours of order being placed. All supplies and materials necessary for operation of the instrument and performance of all patient testing will be available to the DGMC lab at all times.

4.5.2 The Contractor must 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 Part 6 Attachment 2 of this SOW.

4.5.3 The Contractor must consider requirements for routine quality control runs (as defined by the Laboratory Director), routine calibration, periodic calibration/calibration verification in accordance with departmental policy and/or the CAP and troubleshooting of out-of-control assays when calculating the requirements.

4.5.4 The Contractor must 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. An operator level maintenance tool/spare parts kit will be provided, and replenishment of all expended items made by the contractor. Replenishment shall be made as needed on a periodic basis not to exceed the normal preventive maintenance cycle.

4.5.5 Reagents must have a minimum unopened shelf life of two (2) months, and controls must have a minimum unopened shelf life of at least two (2) months upon receipt by the Government.

4.5.6 The Contractor shall sequester quality control materials and test reagents where possible in order to minimize the amount of lot variations sent to the laboratory.

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

4.5.7.1 Be provided by the manufacturer of the equipment.

4.5.7.2 Be marked with the required storage temperature.

4.5.7.3 Inclusive of an English language package inserts.

4.5.7.4 If bulk reagents are produced overseas, documentation of item equivalency must be provided.

4.5.7.5 Preservation and packing must be performed in accordance with the best commercial practice and in such a manner to afford adequate protection against 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 routine deliveries will be made Monday through Thursday, to exclude Federal Holidays.

4.5.7.6 Reagents/materials must 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.

4.5.7.7 The Contractor will provide, upon shipment, an electronic tracking mechanism whereby the Government is able to identify the shipping status of any materials. Deliveries of required items must be in monthly drop shipments. Orders must arrive no later than one week from the requested date of delivery. Any supplies that are placed on back order shall be communicated electronically to the Government, clearly identified on the shipping documents, and delivered in a timely manner, not to exceed ten (10) working days. In the instance a backorder exceeds 10 working days, the Contractor must provide testing services through local sub-contract at their cost.

4.5.7.8 An alternate quality control material must be provided by the contractor if a new lot of controls cannot be delivered one week prior to the expiration date of the lot currently in use.

4.5.7.9 Routine or scheduled orders will arrive no earlier than one week before or later than one week after the scheduled date of delivery. Emergency orders will be delivered within 24 hours after the order is placed, as long as order is placed prior to Overnight/Next Day cutoff.

4.5.7.10 The Contractor shall provide 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.

4.5.7.11 All reagents must be stored at room-temperature, refrigerated, or frozen. At least 95% of reagents must require no preparation or wait time before being loaded on the analyzer. If the vendor cannot meet this preparation requirement, the vendor will disclose what percentage of reagents require preparation and/or wait time at time of RFP.

4.6 Accessibility and Accuracy: All patient and testing information must be accessible and accurate.

4.7 Regulatory Standards: All services provided shall be performed in accordance with all applicable laws, regulations, standards, local instructions, and commercial practices.

4.8 Service Reporting: Contractor shall furnish a legible service report to the Medical Equipment Repair Center (MERC) personnel, signed off by the department, including the date, time, company name and service representative, contract number, description of malfunction, description of any services performed, and any recommendations necessary to maintain equipment in the best operating condition.

4.9 Report Availability: In addition to furnishing the service reports, the Contractor will store these reports and make them available to the Government at any point during the life of the contract.

4.10 Troubleshooting, Repair, and Maintenance: troubleshooting guidance and 24/7 telephone service, including on-call emergency repair by a technical expert, will be provided by the contractor 7 days per week from 0000 to 2359, including Federal Holidays and calibration services, not included in routine maintenance, at frequencies specified in the manufacturer’s service and operations manuals, and any required intervening repair service requirements for the entire contract period, including options if exercised. The DGMC lab will be able to reach a live technical support representative within 30 minutes from initial dialing of technical support number.

4.10.1 The Contractor will maintain all equipment installed under this contract except for repairs necessitated by willful damage or negligence on the part of the Government. This includes emergency repairs as well as Preventive Maintenance Services (PMS), safety tests, calibrations/calibration verifications, and unscheduled repair services in accordance with procedures and practices prescribed by the manufacturer of the equipment.

4.10.2 The Contractor must provide a full unscheduled (maintenance that occurs due to unexpected outages/issues) and PMS throughout the contract. PMS must 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 analyzers, including replacement parts, replacement part shipment costs, and service technician travel costs for performance of maintenance services.

4.10.3 Scheduled routine PMS must be performed between 0730-1630 PST Monday-Friday, excluding Federal Holidays.

4.10.4 The Contractor must 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 must 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 determining the time frame for performance of periodic services.

4.10.5 Upon notification of equipment failure, the Contractor's qualified service technician must establish telephonic contact within 30 minutes of the Government's notification to the Contractors Customer Service "Hotline."

4.10.6 For equipment supporting the Core Laboratory, the service technician must be on-site to provide unlimited service within twelve (12) hours of establishing telephonic contact. The equipment shall be repaired and operational within 48 hours after initial on-site response by the Contractor. Should both urinalysis analyzers become inoperable, the Contractor's service technician must be on-site within four (4) hours of initial notification. The repair of at least one (1) analyzer must be completed within eight (8) hours of initial notification. If deemed necessary, after consultation with the COR, if at least one analyzer cannot be repaired within eight (8) hours of the initial notification, the Contractor shall, where requested, arrange the pickup and delivery of critical specimens to a College of American Pathologists-accredited clinical laboratory, with priority testing service provided for STAT/ASAP specimens. The Contractor shall pay all costs associated with the provision of this alternative testing, including those for delivery of hard copy patient results by express courier, directly to the laboratory, for as long as all analyzers remain inoperable. The Contractor shall provide replacement parts used, as necessary, claimed from local operator level maintenance kits.

4.10.7 The Contractor must provide all reagents, calibrators, controls, and any other materials necessary to troubleshoot analyzer failure.

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

4.10.9 The Contractor's qualified service technician must ensure all repairs are completed and the analyzer is fully operational prior to departing the laboratory. If repairs cannot be completed the same day, the service technician must contact the COR to discuss the situation and provide an estimated date/time of completion. Once complete, the service technician or Customer Service "Hotline" will verify the repairs corrected the problem and the analyzer is operational in a follow-up call. This call will be made in a timely fashion (not to exceed 24 hours) after the service technician departs the lab.

4.10.10 The Government will make the equipment available to the Contractor for servicing at such time and duration necessary to perform needed repairs.

4.10.11 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 is required to correct the deficiency to a fully operational status in accordance with manufacturer specifications.

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

4.10.13 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, or calibration verification (as appropriate), 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.

4.10.14 The Contractor shall notify of the exact date and time for performance of a preventive maintenance service no later than ten (10) days prior to the scheduled preventive maintenance services.

4.10.15 Prior to performing Scheduled Maintenance and Unscheduled Repair Services work, the Contractor's representative shall comply with current vendor reporting procedures at David Grant Medical Center.

4.10.16 Within one (1) working day after completion of a repair, the Contractor's representative shall furnish the COR one (1) copy of a service report for all services performed with a copy to the Equipment Management Branch and the Laboratory Representative for the MTF. The report shall be in English and shall contain, as a minimum, the following information: Nomenclature and serial number, date, description of services performed, duration, location, list of parts or other actions taken to restore operability, and name of technician.

4.11 Charges for Service: The Contractor will bill for services according to the Contract and Approved Price List.

4.12 Uptime: Systems must function with a 100% up-time and ability to perform patient testing 100% of the time. This pertains to having dual platforms. If there is a single platform, up-time and patient testing must be at 98%.

4.13 Standards of Performance: The analyzer must meet the characteristics of performance for precision and accuracy defined by 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).

4.14 Standardized Offerings: Must provide standardized offerings (Standing orders for reagents and controls).

4.15 Alerts: The analyzer must have a method of audibly or visually alerting the operator for sudden out of range quality control.

4.16 Quality Control Fail-Safe: The analyzer must prevent results from entering the patient record in the event of failed quality control.

4.17 Dimensions: The entire urinalysis solution, including all analyzer/modules, will fit on top of a 7 ft x 3 ft tabletop while allowing for multiple operator movement, reagent storage, and bench space. Further, the analyzer must be able to navigate through doorways that are 42” wide by 83” tall. Tabletop that the analyzers will be on must be provided by Contractor.

4.18 Reagent Handling: All reagents must be stored at room-temperature, refrigerated, or frozen. At least 95% of reagents must require no preparation or wait time before being loaded on the analyzer.

4.19 Removal of Equipment: Should the equipment or any component listed herein require repair at the contractor’s plant, contractor shall obtain a signed authorization from the COR authorizing removal of government equipment. Contractor shall not remove any equipment until loaner/replacement installed on-site. Contractor shall be responsible for damage or loss of equipment while in contractor’s possession.

4.20 Upgrade of Equipment: Subject to mutual agreement between the Government and the Contractor, instrumentation may be upgraded within the specifications of the contract as new technology becomes available. Additionally, the Government will add reagents through the life of this contract as a result of advances in technology or changes to clinical practice standards. Any such change to the reagents shall be mutually agreed upon by the contractor and the Government through a bilateral modification.

4.21 Testing Availability: The contractor will provide a minimum volume of the testing amounts described in Part 6, Attachment 2. The contractor will offer options to add more testing if more is needed beyond this estimated volume.

PART 5

DEFINITIONS/ACRONYMS/PUBLICATIONS/HIPAA

Contracting Officer (CO): A person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings.

Contracting Officer’s Representative (COR): An individual, including a contracting officer’s technical representative (COTR), designated, and authorized in writing by the CO to perform specific technical or administrative functions. This individual does NOT have authority to change the terms and conditions of the contract.

Nonpersonal services contract: a contract under which the personnel rendering the services are not subject, either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees.

Quality Assurance Surveillance Plan (QASP): An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance. The Government may either prepare the QASP or require the offerors to submit a proposed quality assurance surveillance plan for the Government’s consideration in development of the Government’s plan.

Acronyms:

AFB Air Force Base ATO Authorization To Operate CAP College of American Pathologists CLIA Clinical Laboratory Improvement Act CLSI Clinical and Laboratory Standards Institute COR Contracting Officer Representative COR Contracting Officer CSI Construction Specifications Institute DGMC David Grant Medical Center DHA Defense Health Agency DMS Data Management System DOD Department of Defense FDA Food and Drug Administration IQAP Interlaboratory Quality Assurance Program IT Internet Technology LIS Laboratory Information System MERC Medical Equipment Repair Center MTF Military Treatment Facility

OSHA

Occupational Safety and Health Administration

PMS Preventive Maintenance Services POP Period of Performance SOW Statement of Work QASP Quality Assurance Surveillance Plan QC Quality Control QCP Quality Control Plan RFID Radio Frequency Identification RFP Request for Proposal RFQ Request for Quote

APPLICABLE PUBLICATIONS

The Contractor must abide by all applicable regulations, publications, manuals, and local policies and procedures outlined in the SOW.

Applicable Publications

Applicable Publications (Current Editions): The Contractor shall abide by all applicable regulations, publications, and manuals. Following is a list of basic publications applicable to the SOW. The most current version of the publication applies. Publications not on the internet or MTF policies and procedures can be obtained from the MTF. Current issues of publications and links to other service publications can be accessed at the following websites:

http://www.apd.army.mil/ http://www.defenselink.mil/pubs http://www.dtic.mil/whs/directives/ http://www.e-publishing.af.mil

Contractors are obligated to follow these codes as mandatory only to the extent that they apply to the 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.

DEPARTMENT OF DEFENSE (DoD) REGULATIONS/MANUALS

INSTRUCTIONS/DIRECTIVES

PUB NO. TITLE

DoDD 5500.7 Standards of Conduct DoDI 5400.7-R Freedom of Information Act DoD 6025.18-R Health Information Privacy Regulation Jan 03 DoDD 8500.1 Information Assurance DoD 8580.02-R HIPAA Security Rule DODI 3020.37 Continuation of Essential DOD Contractor Services During Crises AFI 33-332 Air Force Privacy and Civil Liberties Program DHA-IPM 18-013 Interim Procedures 18-013, Risk Management Framework DHA Contracting Requirements for Medical Device and Equipment Cybersecurity/Risk Management Framework

AIR FORCE INSTRUCTIONS/MANUALS

Publications Code:

AFI--Air Force Instruction AFMAN--Air Force Manual AFP--Air Force Pamphlet AF Form--Air Force Form DD Form--Department of Defense Form MDGI – Medical Group Instruction

Pre-Market Approval Section 510(k) of the Food, Drug and Cosmetic Act requires In Vitro device manufacturers to register with the FDA at least 90 days in advance of their intent to market a medical device. This is known as Premarket Notification - also called PMN or 510(k). Must be in compliance with Section 510(k) of the Federal Food, Drug, and Cosmetic Act for those medical device products intended to be delivered to the Government. Only devices that have received Premarket Notification Approval from the U.S. Food and Drug Administration (FDA) shall be considered for award under this solicitation.

CYBERSECURITY/RISK MANAGEMENT FRAMEWORK

Contractor will ensure all Medical Device Equipment is in compliance with applicable requirements in DHA Cybersecurity and Risk Management Framework as referenced in “DHA Medical Device Equipment Cybersecurity – Service Maintenance Agreement Contracting Requirements” and “DHA

Medical Device Equipment Cybersecurity – Risk Management Framework Contracting Requirements”.

Attachment 4 and 5 Facilities/Cybersecurity Requirements.

PART 6

6.0 ATTACHMENTS/TECHNICAL EXHIBIT LISTING

ATTACHMENT 1

PERFORMANCE REQUIREMENTS SUMMARY

Performance Objective

Ref Performance Threshold

Method of Surveillance

Procedure

PRS # 1

The Contractor shall provide a Urinalysis system that functions with a 99% up-time and ability to perform patient testing 99% of the time

PWS

Part 4, Section 4.12

99% or higher up-time.

100% Inspection 100% evaluation of any instrument downtime resulting in complete or partial loss of testing capability. Cumulative length of downtime will be compared to cumulative uptime to calculate percentage uptime.

PRS # 2

Must have technical support available 24/7, 365 days per year.

Part 4, Section 4.10

100% availability within 30 minutes at all times.

100% Inspection 100% investigation of any instance in which the DGMC laboratory is unable to reach a live technical support representative within 30 minutes from initial dialing of technical support number.

PRS # 3

Analyzer meets characteristics of performance for precision and accuracy defined by 1988 CLIA and CLSI.

Part 4, 4.13

100% 100% Inspection 100% inspection of any failure to meet precision and accuracy assessments.

PRS # 4

Maintain records of maintenance and instrument service.

Part 4, Section 4.10.16

100% Record Upkeep

100% Inspection 100% inspection of all service reports following receipt of service from contractor.

PRS #5

All supplies and materials available.

Part 4, 4.5.1

100% Availability

100% Inspection 100% inspection of any instance in which the DGMC laboratory loses any testing capability due to inaccessibility of supplies or materials.

PRS #6

Maintain training requirements annually for each piece of equipment.

Part 4, Section 4.2

90%, ensuring an alternative is given when normal means of training are not available

Periodic Inspection

Periodic surveillance of laboratory personnels’ competency with equipment.

PRS #7

Preventive maintenance is upkept by the contractor and always performed within its recommended timeframe.

Part 1, Section 1.3.6

100% performed on time

100% Inspection Periodic surveillance of preventative maintenance records, ensuring the timely performance of preventative maintenance within the manufacturers recommended timeframe.

PART 6, ATTACHMENT 2

ESTIMATED WORKLOAD DATA

ITEM TEST NAME ESTIMATED ANNUAL

QUANTITY

1 Urinalysis with Microscopy

(Microscopy is performed with every urine sample)

PART 6, ATTACHMENT 3

DELIVERABLES SCHEDULE

Deliverable Frequency Medium/Format Submit To Applicable to:

Mission Essential Plan

Delivered Within 30 days after award

DGMC COR &

60 CONS/CO

All

Implementation plan and Schedule

Delivered Within 30 days after award

DGMC COR &

60 CONS/CO

All

CDRL A001 –

Quality Control Plan

Within 30 days of contract award

Contractor’s discretion

CDRL A001 to CO All

PART 7

7.0 FACILITY MODIFICATIONS/INSTALLATION

7.1 Contractor shall provide a fully operational turn-key system, meeting all minimum requirements and essential characteristics for each respective analyzer per the Statement of Work. Prior to any such facility modifications, the Contractor will present the final plans and cost estimates with a detailed statement of work to Facility Management (FM) office for review. These shall be presented in accordance with the Construction Specifications Institute (CSI) 50-division format with standardized divisions with all costs broken out. The final quotation shall include all site preparation, construction, extended installation, incidental services, labor, shipping, supplies, materials the Contractor will be responsible for to provide a fully operational turn-key system, meeting all minimum requirements and essential characteristics for each respective analyzer. Contractor will also provide visual representations (red-line drawings, drafts, diagrams, mock-ups, screenshots, etc.) to FM for review. Contractor shall provide all licenses required to complete this project as outlined and all associated fees and payments. Upon review and concurrence, all plans and documentation and any associated billable costs will be sent to Contracting Officer for final approval.

7.2 During the site survey/visit, the Contractor shall be responsible for determining all site-specific requirements necessary to ensure proper installation and operation of the system within required space per equipment specifications. It shall be the Contractor's responsibility to determine any information necessary to accomplish the installations.

7.3 Vendors are advised that there will be an opportunity, during solicitation, to visit the site and should bring all needed personnel to prepare their site preparation offer.

7.4 All work and material will follow the Whole Building Design Guide (WBDG.org), Unified Facilities Criteria 4-510-01, Change 3, Design: Military Medical Facilities, OSHA and the NFPA. Where there is any conflict in standards or codes the stricter of the two shall be followed. It is the responsibility of the contractor and any subcontractor to provide workmanship, parts, and materials in accordance with this scope of work. Associated with this shall be the workmanship of all work performed to adhere and conform to industry standards and common practices of the trades and professions.

7.5 Review of the facility modifications by the FM office in no way constitutes acceptance and/or approval. The Contracting office has the final authority.

PART 8

8.0 CYBERSECURITY/RISK MANAGEMENT FRAMEWORK

8.1 Contractor will ensure all Medical Device Equipment is in compliance with applicable requirements in DHA Cybersecurity and Risk Management Framework as referenced in “DHA Medical Device Equipment Cybersecurity – Service Maintenance Agreement Contracting Requirements” and “DHA Medical Device Equipment Cybersecurity – Risk Management Framework Contracting Requirements.”