Attachments 1 PWS and Attachment 2 Estimated Workload Data.pdf

DHA PWS Template V13 November 16, 2021

Department of Defense Defense Health Agency

Performance Work Statement

Wet Chemistry and Immunoassay Platform Lease and Cost Per Reportable Result (CPRR) Testing Services

6th Medical Group, MacDill AFB, FL

Solicitation Number:

Version: 1

Date: 8 July 2025

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PART 1

1.0 GENERAL INFORMATION

1.1 This is a non-personal services contract to provide Wet Chemistry/Immunology Platform cost-per-reportable-result (CPRR) services utilizing one new mid-volume integrated Chemistry / Immunology platform or one new mid-volume Chemistry platform and one new Immunoassay (special chemistry) platform in support of the 6th Medical Group, MacDill Air Force Base (AFB), Florida.

1.2 Description of services/introduction: This requirement is to provide cost-per-reportable-results (CPRR) clinical laboratory reagents and consumables. The contractor shall provide one new mid-volume integrated Chemistry / Immunology platform or one new mid-volume chemistry platform and one new Immunoassay (special chemistry) platform. The contractor shall provide accessories technology, testing methodologies, quality control, training, technical support and maintenance. The chemistry platforms must perform the required in-house laboratory tests that are ordered on a routine or emergent basis. Clinical diagnostic testing is vital in the detection, diagnosis and monitoring of diseases and are essential in the treatment of pathologic processes. It is vital that test samples have expeditious turnaround times for the critical diagnosis of acute diseases and chronic diseases.

The contractor shall provide all equipment, perform installation qualification, operational qualifications, performance qualifications, software and hardware installation, quality control, and maintenance. The contractor shall provide all accessories, workstation, monitor, water purification system, and uninterruptible power supply (UPS), as required, for this cost-per-reportable-results (CPRR) reagents and consumables to perform clinical chemistry laboratory testing services as defined in the Performance Work Statement (PWS).

The contractor shall provide all personnel, supplies, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform wet Chemistry and Immunoassay Platform Services, as defined in this Performance Work Statement (PWS) except for those items specified as government furnished. The contractor shall perform to the standards in this PWS.

1.3 Background: The mission of the 6th MDG is a straightforward one: “Mission Focused – To Prevent, Heal, and Deploy!” The 6th MDG provides comprehensive health care to the Department of Defense (DoD’s) largest single-unit catchment area, supporting over 265,000 eligible beneficiaries.

This acquisition is a follow-on to the Firm-Fixed Price (FFP) contract FA481422P0033 for Chemistry Analyzer and Immunoassay System with type-one reagent grade water system, maintenance, and reagents in support of the 6th MDG, MacDill AFB, FL.

1.4 Objectives: The 6th MDG has a requirement for a non-personal services contract to provide wet chemistry/Immunology cost-per-reportable- result (CPRR) services. The general requirements for the contractor are:

- Provide suitable equipment that fits the space constraints mentioned with the PWS

- Supply all materials and reagents to meet the demand signal identified within the PWS

- Perform all required preventative maintenance to minimize down time of the instrument

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- Include process to timely address unscheduled maintenance issues

1.5 Scope: Services includes furnishing and installing one new mid-volume integrated Chemistry / Immunology platform or one new mid-volume chemistry platform and one new Immunoassay (special chemistry) platform. The contractor shall provide all requirements, as defined in the PWS.

Additionally, services includes calibration, diagnostic instrument and water filtration system, and all reagents analysis for wet chemistry laboratory testing, to include preventive maintenance and corrective maintenance for the chemistry platforms and all system components, telephonic technical support with on-site technical support dispatched, provide hardware and software updates, as necessary, at no additional cost to the Government, and provide regularly scheduled preventive maintenance, corrective maintenance, inspection, analyzer calibration every six (6) months or annually, as per manufacturer’s recommendation at no additional cost to the Government. The chemistry platforms shall be capable of performing at the minimum, but not limited to, the clinical laboratory testing, as listed in the PWS.

The contractor shall maintain the instrument and all system components within the original equipment manufacturers (OEM) specifications in accordance with the United States, State, and Local law and regulations, Defense Health Agency (DHA) regulations, instructions, and the Joint Commission (TJC) requirements, and the College of American Pathologists’ requirements. The contractor must maintain any networkable systems such that they meet DHA cyber security requirements. The contractor shall ensure the chemical platforms are compatible with the Medical Group’s laboratory information system (LIS) which is the MHS Genesis and must include all normal ranges, reference intervals and units of measurement for each assay.

1.5.1 Preventive maintenance and corrective maintenance, as required, includes making repairs, adjustments, calibrations, hardware and software manipulation and/or upgrades or other actions taken to return the chemistry platforms to original manufacturers specifications following a failure, damage, or other incident that causes the chemistry platforms to no longer perform within the original specifications.

1.5.2 The contractor shall accomplish and provide telephone support during normal business hours 0730 and 1630. The contractor shall provide preventive maintenance, corrective maintenance, inspection, and unlimited emergency responses by the Contractor’s certified Field Service Engineers/technicians for the instrument. All maintenance provisions shall apply to hardware, firmware, and software, as appropriate, unless otherwise stated.

1.5.3 The contractor shall provide unscheduled support/service coverage between the hours of 0730 and 1630 (Eastern Standard Time), Monday through Friday, excluding United States Federal Government holidays, which are identified in 1.7.2.

1.5.4 Should the contractor choose to subcontract any services within this PWS, the subcontractor must also meet all requirements herein. If, at any point, the subcontractor(s) does not meet the requirements, the contractor shall be held accountable and may be requested to realign the method of completing those specific services via a different subcontractor.

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1.5.4.1 Service contract covering the term of this contract are the responsibility of the contractor, if required.

1.6 Period of Performance (PoP): The Period of Performance (PoP) consists of a base period of 4 June 2026 - 30 September 2026; four 12-month option periods; one 8-month option period; and the potential to extend services for an additional six months in accordance with FAR 52.217-8, Option to Extend Services.

1.6.1 Transition: Transition-in period

1.6.1.1 Transition-in period: Full performance start date is 4 June 2026. Transition-in performance is defined as a 6-month overlap between the current instrument and the incoming instrument.

During the transition-in period, the contractor shall prepare to meet all contract requirements and ensure all key operators and staff at the 6th MDG are functionally trained and qualified on the full performance date of the instrument. The contractor shall perform and pay for all correlation and validation testing to ensure that the instrument can perform all required tests, as detailed in the PWS.

Correlation and Validation must be completed within 60 days of installation. The contractor shall ensure that the instrument(s) meet all Clinical Laboratory Improvement Amendments (CLIA) and Clinical and Laboratory Standards Institute (CLSI) requirements and shall ensure the instrument is fully operational for patient testing. The contractor shall provide the support, the instrument manual, and supplies necessary to complete the validation process through the Joint Commission and the College of American Pathologists.

1.7 Administrative specifications

1.7.1 Place of performance: The work shall be performed at the 6th Medical Group (MDG) 3250 Zemke Avenue, MacDill AFB, FL 33621.

1.7.2 Recognized Federal holidays: Services will not be performed on 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

1.7.3 Hours of operation: The contractor is responsible for conducting business Monday through Friday between the hours of 0730 and 1630, except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. The contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons.

1.7.4 Reserved.

1.8 Reserved.

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1.9 Reserved.

1.10 Quality

1.10.1 Quality Control (QC): The contractor shall develop and maintain an effective QC program to ensure services are performed in accordance with this PWS. 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 shall submit the OC program to the COR for acceptance no later than 30 days after contract award. The COR will notify the contractor of acceptance or required modifications to the plan within 30 days of receiving the QC program. The contractor shall make appropriate modifications and obtain acceptance of the QC program by the COR within 15 days. A comprehensive written QC program shall be submitted to the CO and COR within 5 working days when changes are made thereafter. 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.

Any changes to the QC plan shall be submitted and approved in 10 business days.

The QC program shall include the following:

A description of the inspection system to cover all services listed in the PWS. 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 combination should be included.

A description of the methods to be used for identifying and preventing defects in the quality of service performed.

A description of the records to be kept to document inspections and corrective or preventive actions taken.

All records of inspections performed shall be retained and made available to the Government upon request throughout the contract period of performance, and for the period after contract completion until final settlement of any claims under this contract.

List of Research WEB sites that may be needed in reference to DOD, DHA, and other Instructions/ Memos:

DoD 8570.01-M: http://www.dtic.mil/whs/directives/corres/pdf/857001m.pdf ADA Section 508: http://www.ada.gov/2010_regs.htm

1.10.2 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).

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1.11 Contractor personnel

1.11.1 Reserved.

1.11.2 All contractor personnel requiring admission onto base must coordinate a date and time with the 6th MDG laboratory leadership to have a pass issued. All contractor personnel requiring access to the base must present a valid driver’s license, vehicle registration and vehicle insurance to visitor’s center to obtain a daily pass to the base.

1.11.3 Physical Security: The contractor shall be responsible for safeguarding all government equipment, information and property provided for contractor use. At the close of each work period, government facilities, equipment, and materials shall be secured.

1.11.4 Reserved.

1.11.5 Reserved.

1.12 Reserved.

1.13 Reserved.

1.14 Reporting

1.14.1 Reserved.

1.14.2 Reserved.

1.14.3 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; coordinate availability of government furnished property; and provide site entry of contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the contractor, states the responsibilities and limitations of the COR, especially regarding changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting contract.

1.14.4 Post award conference/periodic progress meetings: The contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with FAR Subpart 42.5. The CO, COR, and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. 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.

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Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.

1.15 Contractor Identification

1.15.1 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. All contractor personnel shall identify themselves as contractor support personnel in all forms of communication with all entities with whom DHA/Deputy Assistant Director for Acquisition (DAD-A)/Head of the Contracting Activity (HCA) has business dealings. The contractor shall: Answer all telephone calls and have a personalized voice message with an introductory statement that includes the fact that the person is contractor support personnel. Ensure all those with whom the person interacts in any face-to-face dealings while supporting the DAD-A understands that the person is contractor support personnel. Include a title block in all emails that states the fact that the person is contractor support personnel. Ensure all those with whom the person interacts in any face-to-face dealings while supporting DHA/DAD-A/HCA understands that the person is contractor support personnel.

1.15.2 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.

1.15.3 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.

1.15.4 Contractor personnel requiring access to the military base and/or Government facility must adhere to all applicable base regulations, policies, and procedures, to include showing proper identification, observing and complying with safety standards and security protocols while on Government property.

1.16 Contractor Access to Health Affairs (HA)/DHA Network(s)

1.16.1 FSO/Company's Security POC shall notify the DHA Personnel Security Office after being awarded a contract that requires access to a DoD system (If applicable, if not delete 1.16.1 and 1.16.2 and replace to 1.16 Reserved). Contractor personnel requiring access to the HA/DHA networks for performance of their tasks require a background investigation and the security awareness training. The contractor shall be prepared for this process as it could take two (2) or more weeks. The FSO/Security POC shall submit a Standard Form (SF) 85/86 to DHA's Personnel Security Office for a background investigation.

1.16.2 Company's FSO/Security POC must notify the Personnel Security Office when the contractor has submitted the SF-85/86. The FSO/Security POC, or the COR must notify the DHA Personnel Security Office in writing of a contractor's termination from the contract, including the termination date.

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1.17 Personnel Security

1.17.1 The contractor shall comply with DoD 8570.01-M, “Information Assurance Workforce Improvement Program, CH4” November 10, 2015 as amended; 8500.01, “Cybersecurity”, dated March 14, 2014; DoD Manual (DoDM) 6025.18, “Implementation of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule Compliance in DoD Health Care Programs” dated March 3, 2019, Department of Defense Instruction (DoDI) 6025.18 “HIPAA Privacy Rule Compliance in DoD Health Care Programs”, dated March 13, 2019; and DoDM

5200.02 “Procedures for the DoD Personnel Security Program (PSP),” incorporation change 3, effective September 24, 2020.

1.17.1.1 Reserved.

1.17.1.2 Reserved.

1.17.1.3 Reserved.

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PART 2

2.0 DEFINITIONS, ACRONYMS, AND APPLICABLE PUBLICATIONS/INSTRUCTIONS

2.1 Definitions:

2.1.1 Category D: Information Technology (IT) and Telecommunications Services (called D- Services)

2.1.2 Category R: Support (Professional/Administrative/Management) Services (called R-Services)

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

2.1.4 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.

2.1.5 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.

2.1.6 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.

2.1.7 Clinical Laboratory Improvement Amendments (CLIA). This activity requires that any facility performing examinations of human specimens (e.g., tissue, blood, urine, etc.) for diagnosis, prevention, or treatment purposes to be certified by the Secretary of the Department of Health and Human Services (DHHS).

2.1.8 Calibration: This activity is the process of testing and adjusting an instrument or test system to establish a correlation between the measurement response and the concentration or amount of the substance that is being measured by the test procedure to ensure consistent, standardized performance or output as per the original equipment manufacturer recommendations.

2.1.9 Calibration Verification Inspection: This refers to assaying of materials of known concentration in the same manner as patient samples to substantiate the instrument or test system’s calibration throughout the reportable range for patient test results.

2.1.10 Contractor Performance Assessment Reporting System (CPARS): Web enabled application that collects and manages the library of automated CPARs.

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2.1.11 Corrective Maintenance: Repair, adjustment, calibration, software manipulation and upgrades or other action taken to return a piece of equipment to original equipment manufacturer’s specifications following a failure, damage, or other incident that causes the product to no longer perform within the original specifications.

2.1.12 Inspections: The activity of doing functional testing and safety inspections of a medical device at regular intervals to ensure that the equipment is safe for use in accordance with manufacturer’s recommended procedures.

2.1.13 Medical Treatment Facility (MTF) or Patient Care Facility: All gross square footage for building with a primary function of delivering Government health care services. (i.e. hospital or clinic, including all activities providing outpatient and/or inpatient health services for authorized patient care)

2.1.14 Original Equipment Manufacturer (OEM): The company which has created a specific model of product/device.

2.1.15 Preventive Maintenance: Preventive maintenance is used to describe those periodic and “as required” services necessary to maintain equipment in an operating condition which minimizes corrective maintenance, including but not limited to calibration, adjustment, lubrication, updating software for security, safety or system functionality issues, as well as that testing required to maintain a safe environment of care which includes electrical safety testing, output testing, replacement of batteries and other components on a scheduled basis (which becomes corrective maintenance if the component fails due to lack of preventive maintenance).

2.1.16 Quality Assurance (QA): Actions, including inspections, performed by the Government to determine whether products and services conform to contract requirements.

2.1.17 Quality Assurance Evaluator (QAE): A Government employee responsible for performing quality assurance functions for a contracted service.

2.1.18 Quality Control (QC): Actions, including inspections and preparation of inspection records, performed by the Contractor to ensure that products and services conform to contract requirements.

2.2 Acronyms:

AIS Automated Information System APL Approved Products List APL AQL Acceptable Quality Level ARRT Acquisition Requirements Roadmap Tool ATO Authority to Operate B2B Business-2-Business CAC Common Access Card CAP Cloud Access Point CCEVS Common Criteria Cybersecurity Evaluation and Validation Scheme CDI Covered Defense Information

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CE Computer Environment CDRL Contract Data Requirement List CIO Chief Information Officer CJCSM Chairman of the Joint Chiefs of Staff Manual CLIA Clinical Laboratory Improvement Amendments CLSI Clinical and Laboratory Standards Institute CMMC Cybersecurity Maturity Model Certification CMR Contractor Manpower Reporting CNSSI Committee on National Security Systems Instruction CO Contracting Officer(s) CONUS Continental United States (excludes Alaska and Hawaii) COR Contracting Officer Representative CPRR Cost Per Reportable Results COTR Contracting Officer's Technical Representative CSP Cloud Service Provider CSSP Cyber Security Service Provider CUI Controlled Unclassified Information DAD-A Deputy Assistant Director for Acquisition DC3 DoD Cyber Crime Center DD Form 254 Department of Defense Contract Security Requirement List (if applicable) DB Design-Build DBB Design-Bid-Build DFARS Defense Federal Acquisition Regulation Supplement DHA Defense Health Agency DISA Defense Information System Agency DoD Department of Defense DoDD Department of Defense Directive DoDI Department of Defense Instruction DSAs Data Sharing Agreements DSAA Data Sharing Agreement Application DMZ Demilitarized Zone DoDM Department of Defense Manual DPCLO DHA Privacy and Civil Liberties Office DUA Data Use Agreement eMSM Enhanced Multi-Service Markets EULA End User License Agreement EVM Earned Value Management FAR Federal Acquisition Regulation FCI Federal contract information FE Facilities Enterprise FedRAMP Federal Risk Authorization and Management Program FISMA Federal Information Security Modernization Act FRCS Facility Related Control Systems FSO Facilities Security Officer HA Health Affairs HIPAA Health Insurance Portability and Accountability Act

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HCA Head of the Contracting Activity HIT Health Information Technology IGCE Independent Government Cost Estimate IA Information Assurance IO Initial Outfitting I/O In/Out Processing Portal IPv Internet Protocol Version IS Information System ISP Internet Service Provider IT Information Technology ISCM Information Security Continuous Monitoring IV&V Independent Verification & Validation MedCOI Medical Community of Interest MHS Military Health System MIL-STD Military Standard MTFs Military Treatment Facilities NCR National Capitol Region NDA Non-Disclosure Agreement NIAP National Information Assurance Partnership NIST National Institute of Standards and Technology OCONUS Outside Continental United States (includes Alaska and Hawaii) ODC Other Direct Costs OPM Office of Personal Management OSD Office of the Secretary of Defense P-ATO Personal Authorization to Operate P&R Personnel and Readiness PGI Procedures, Guidance and Information PDT Project Delivery Team PHI Protected Health Information PII Personally Identifiable Information PIT Platform Information Technology PK Public Key PKI Public Key Infrastructure POA&M Plan of Action and Milestones POC Point of Contact PMO Program Management Office PoP Period of Performance PP Personal Property PPSM Ports, Protocols, and Services Management PRS Performance Requirements Summary PSP Personnel Security Program PWS Performance Work Statement QA Quality Assurance QAP Quality Assurance Program QASP Quality Assurance Surveillance Plan QC Quality Control

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QCP Quality Control Plan RFP Request for Proposal RFQ Request for Quotation RMF Risk Management Framework SP Special Publication SPRS Supplier Performance Risk System SRM Sustainment, Restoration and Modernization SRG Security Requirements Guides STIG Security Technical Implementation Guides TOS Terms of Service US United States UFC Unified Facilities Criteria VPN Virtual Private Network XML Extensible Markup Language

2.3 Applicable Publications, DHA Administrative Instructions (AI), etc. None

2.3.1 1910.1450, Occupational Safety and Health Standards, Code of Federal Regulations.

2.3.2 DoD Instruction 8510, Risk Management Framework (RMF) for DoD Information Technology

(IT)

2.3.3 NIST SP 800-37, Rev. 2, Risk Management Framework (RMF) for Information Systems and Organization: A System Life Cycle Approach for Security and Privacy, December 2018, as amended.

2.3.4 NIST SP 800-53, Rev 5, Security and Privacy Controls for Information Systems and Organizations, as amended.

2.3.5 DoD Instruction 6025.18-R, DoD Health Information Privacy Regulation, dated 13 March

2.3.6 DoD Instruction 8580.02, Security of Individually Identifiable Health Information in DoD Health Care Programs, dated 12 August 2015

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PART 3

3.0 GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

The Requiring Activity Authority has assessed the need for Government Furnished Property, Equipment, and Services and determined:

3.1 Services: The Government:

Will NOT provide Government Furnished Services in support of this contract/task order. As a result, this paragraph is Not Applicable.

WILL provide Government Furnished Services required in support of this contract/task orders.

These Services are described below: N/A

3.2 Facilities: The Government:

Will NOT provide Facilities in support of this contract/task order. As a result, this paragraph is Not Applicable.

WILL provide Facilities in support of this contract/task orders. The Government provided Facilities are described below: 6th Medical Group (MDG), 3250 Zemke Ave, MacDill AFB, FL 33621. The Government will provide adequate space, environment, all utilities, electrical power, and data connections for the proper operation and maintenance of the required chemistry platforms, as well as proper storage environment for all related reagents and warehouse facilities to properly receive ongoing shipments of reagents and/or parts.

3.3 Utilities: The Government:

Will NOT provide Utilities in support of this contract/task order. As a result, this paragraph is

WILL provide Utilities in support of this contract/task orders. The Government provided Utilities are described below: All utilities required for performance of these services will be provided by the government.

3.4 Equipment: The Government:

Will NOT provide Equipment in support of this contract/task order. As a result, this paragraph is

WILL provide Equipment in support of this contract/task orders. The Government provided Equipment is described below:

3.5 Materials: The Government:

Will NOT provide Materials in support of this contract/task order. As a result, this paragraph is

IS providing Materials in support of this contract/task orders. The Government-provided

Materials are described below: N/A

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PART 4

4.0 CONTRACTOR FURNISHED ITEMS AND SERVICES

4.1 Services: The Contractor:

Will NOT provide Contractor Furnished Services in support of this contract/task order. As a result, this paragraph is Not Applicable.

WILL provide Contractor Furnished Services required in support of this contract/task orders.

These Services are described below: As defined under Section 5 of this PWS.

4.2 General: The contractor shall furnish all supplies, equipment, and services required to perform work listed under Section 5 of this PWS.

4.3 Secret Facility Clearance: N/A

4.4 Materials: The contractor shall provide all consumables necessary to perform the established workload provided in the PWS (e.g., calibrators, reagent packs, manufacturer specific Quality Control Material (if required), replacement parts, etc.).

4.5 Equipment: The contractor shall provide all equipment necessary to perform the services under Section 5 of this PWS.

4.6 Facilities: N/A

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PART 5

5.0 SPECIFIC TASKS

5.1 WET CHEMISTRY PLATFORM

5.1.1 Task Description and Deliverables:

The contractor shall provide one new mid-volume integrated Wet Chemistry/Immunology platform or one new mid-volume Wet Chemistry platform and one new Immunoassay (special chemistry) platform. All platform and accessories technology, testing methodologies, quality control and reagents used onboard the platform shall be approved by and compliant with the United States (U.S.)

Food and Drug Administration (FDA) requirements. The platform and reagents shall be in compliance with the 1910.1450 Occupational Safety and Health Administration (OSHA), Code and Federal Regulations.

The platform and all equipment and accessories shall be new from the manufacturer. Any used or refurbished platform, equipment, or accessories obtained from a third (3rd) party source shall not be accepted by the Government. The contractor shall be responsible for the return of used or refurbished platform, equipment, or accessories at no cost to the Government.

All equipment and accessories shall be installed and validated in accordance with (IAW) the Clinical Laboratory Improvement Amendments (CLIA) and Clinical and Laboratory Standards Institute (CLSI) standards by the contractor and all minor electrical and plumbing to be included during the installation process (i.e., water sources, filtration systems, and electrical panel requirements).

The contractor shall provide all necessary training required to operate the instrument to all laboratory personnel at time of delivery. Training and associated expenses (room, board, and airfare) for 2 key operator(s) per instrument for the base year of the contract and 1 key operator per instrument for each option year shall be included.

The contractor shall provide one new mid-volume integrated Chemistry / Immunology platform or one new mid-volume chemistry platform and one new Immunoassay (special chemistry) platform that shall meet the requirements defined in the PWS.

The contractor shall possess an Authority to Operate (ATO) or must be able to obtain an ATO upon receipt of award in order to connect with DHA network and be capable of connecting to MHS Genesis Health Record for bidirectional transfer of patient lab orders and results.

5.1.2 Essential Characteristics:

5.1.2.1 The platform must not exceed 11 feet long, 5 feet width, and 5 feet high to fit in the allocated space area.

5.1.2.2 Tests: The Platforms, at a minimum, must be able to perform the following tests from primary collection tubes:

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Albumin (ALB) Alcohol/Ethanol

(ALC/ETOH)

Alkaline Phosphatase

(ALK/ALKP)

Alanine Aminotransferase (ALT) Aspartate Aminotransferase

(AST)

Direct Bilirubin (dBILI)

Total Bilirubin (TBILI) Blood Urea Nitrogen (BUN) Bicarbonate (ECO2)

Calcium (CA) Cholesterol (CHOL) Chloride (CL)

Creatinine (CREAT) Gamma-Glutamyl Transferase (GGT)

Glucose (GLUC)

Hemoglobin A1C (HbA1C) High Density Lipoprotein

(HDL)

High Sensitive C-Reactive Protein (HSCRP)

Potassium (K) Phosphate (PHOS) Magnesium (MG)

Sodium (NA) Triglyceride (TRIG) Total Protein (TP)

Total Prostate-Specific Antigen

(TPSA)

3rd generation Thyroid- Stimulating Hormone (TSH)

Free Thyroxine (FT4)

5.1.2.3 Perform more than 25 HbA1Cs per hour without pretreatment and aliquoting sample from original collection tube. The HbA1C test must be able to be run in a full HbA1C sample rack.

5.1.2.4 Contractor shall provide a self-contained type-one reagent grade water system adequate to support the platform for operation, liquid ready to use reagents and no required temperature equilibration or reconstitution.

5.1.2.5 Reagent cartridge must be >200 tests capacity for Comprehensive Metabolic panels with no disposable cuvettes for regular chemistry testing platform.

5.1.2.6 Platform must have load on the fly capabilities for reagents, samples, bulk solutions and consumables without having to stand-by the instrument or wait for temperature equilibration for these functions. Instrument must be able to repeat and reflex test, auto-rerun and auto-dilute.

5.1.2.7 Platform shall feature error-proof reagent and commodity design with built in safeguards to prevent reagent mix-ups, probe crashes.

5.1.2.8 Platform shall prevent the user from performing tests on a reagent that has not been calibrated.

5.1.2.9 Platform shall alert user if a reagent has exceeded on-board stability or has exceeded the lot expiration date.

5.1.2.10 Except for electrolytes and up to three additional analytes, the frequency of calibration of both regular chemistry and immunoassay (special chemistry) must occur no sooner than 7 days.

5.1.2.11 Platform must have an audible alarm and/or visual alerts to prompt user to perform calibration.

5.1.2.12 Quality control frequency must not exceed once per 8 hours and IAW CAP requirements.

5.1.2.13 Platform must have QC notification capability to alert the user when QC is not acceptable and/or not performed.

5.1.2.14 The platform must have easy access (front and/or top of platform) for part replacement.

5.1.2.15 The systems shall be able to assess the level of common indices (hemoglobin, lipemia, icterus) for each sample. If additional materials are needed, the extra materials shall be included in the cost.

5.1.2.16 Platform shall be able to perform quality controls using third party quality control material.

5.1.2.17 Platform shall be able to detect clots and have an auto-clearing mechanism.

5.1.2.18 Immunoassay platform shall be capable of running STAT samples and auto reflex testing.

5.1.2.19 Platform shall accommodate a throughput of up to 100 tests per hour random access for running any combination of samples at any time. In addition, must have rapid kinetics for improved turnaround time.

5.1.3 Reagents, Consumables, and Controls

The contractor shall provide all necessary reagents, consumables, calibrators, and quality control material to support the clinical diagnostic testing conducted by the Laboratory at the 6th MDG.

Additionally, services shall include recurring shipment of reagents, consumables, and materials at no additional cost to the Government.

Reagent packs must be able to be loaded without taking the instrument into a stand-by mode or offline entirely, i.e., reagents and consumables.

Multiple quality control materials must be available to provide measurements for all parameters on the system through the analytic measurement range.

The contractor shall perform all instrument calibrations and provide all calibration and quality control materials at no cost to the Government. If extensive reagent/calibrator, quality control material is exhausted during troubleshooting, it is the contractor' s responsibility to replenish that supply to the Government.

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5.1.3.1 Reagent Consumables: Contractor shall provide any corresponding liquid reagent ready to use w/o temperature equilibration to perform each test.

5.1.4 Peer Group Data: The contractor must provide six sigma data (peer group data) on chemistry testing which is verified by 3rd party source, using Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP) guidelines.

5.1.5 Product Recalls: The contractor shall provide a copy of the number of product recalls for the requested tests identified in Section 5.1.2.2 within the last 12 months and within 14 days from the date of initiating recall. All requested assays must be FDA approved.

5.1.6 Equipment Support / Scheduled Maintenance:

5.1.6.1 Computer software must include integrated on-board operational manual support to include management of quality control data, training, maintenance, and troubleshoot tips.

5.1.6.2 The contractor shall provide a written operational manual.

5.1.6.3 The manufacturer shall provide an Uninterrupted Power Supply (UPS) for each platform capable to complete testing in progress as well as protection against electrical fluctuations.

5.1.6.4 The contractor shall be responsible for all Annual Preventative Maintenance (PMs) and repairs at no additional cost to the Government. The PM work must meet or exceed the manufacturer's recommendations.

5.1.6.5 All Preventative Maintenance and repairs must be coordinated with the Medical Maintenance Office in room 1J31 at (813) 827-9620 during normal business hours. When personnel arrive, they must check in with the Medical Maintenance Office first, and then will be escorted to the facility management office to get a visitor's badge.

5.1.6.6 The Contractor shall maintain the wet chemistry analyzer within the OEM’s specifications and shall make no modifications to the original design. The Contractor shall furnish and install all software and equipment modifications per the OEM’s specifications and standards. Modifications can be scheduled during the next PMI or as a service call during the term of the contract.

5.1.6.7 Contractor shall provide, in writing, the name and direct toll-free telephone number(s), and email address(es) of a primary and alternate, English-speaking, individual to act as their representative for the scheduling and coordination of service calls. The contractor’s POC must be available for service calls between the hours of 0730 and 1630 ET Monday through Friday, excluding Government holidays.

5.1.6.8 The contractor shall provide any routine and special items required to operate and maintain the equipment in optimal condition such as: linearity materials for initial integration, printers, consumable equipment parts, and required replacement parts for maintenance or service.

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5.1.6.9 Spare Part/Test Equipment Requirements: Prior to performing any maintenance on the system, the contractor must provide proof of access to the original equipment m anufacturer's spare parts and the recommended test equipment required for preventive maintenance inspections (PMIs), to include calibration and corrective maintenance.

The contractor shall validate assays on the new instrument. Correlation between current instrument and new instrument must be provided for approval/implementation by the Laboratory Medical Director. Evidence of validation shall be in accordance with Clinical and Laboratory Standards Institute (CLSI), EP9-A22, Method Comparison and Bias Estimation Using Patient Samples.

Contractor shall supply all uninterrupted power source units required for uninterrupted performance of the wet chemistry analyzer.

Contractor shall ensure maintenance support to all software, hardware and firmware through the contract period plus all option years to include all upgrades, patches and versions which may or may not require a new authority to operate (ATO).

5.1.7 Corrective Maintenance: The contractor shall provide for any corrective maintenance services, as necessary, to maintain the chemistry platform within the original manufacturer’s specification, and in accordance with any applicable FDA and/or Joint Commission requirements.

Corrective maintenance shall include repairs for the chemistry platform, to include problems resulting from, but not limited to, unintentional damage, operator error, normal wear and tear, component part failures, environmental issues (e.g., water damage), etc.

5.1.7.1 The contractor shall provide on-site repair support to correct all malfunctions which may occur. All tools, test equipment, parts, and supplies necessary to return the system to original manufacturer’s specifications shall be the responsibility of the contractor. If the chemistry platform needs to be removed from the MTF, a loaner chemistry platform must be provided by the contractor, at the cost of the contractor, prior to the removal of the defective chemistry platform. All corrective maintenance performed shall be documented and made available for Government review upon request. The chemistry platform shall not need more than two (2) annual unscheduled field service visits per year.

5.1.7.2 Within one (1) hour of notification by the BMET TL, Contractor technical personnel shall respond by telephone within the same day. If the equipment cannot be restored to the operating condition via telephone technical support, the Contractor personnel shall arrive onsite within eight (8) hours to complete the requested services or repair(s)once notified of unscheduled maintenance or repairs. The onsite response time is measured from the time the Contractor is originally called, not from the time the Contractor returns the call. Onsite responses will only be rendered under this contract during the hours of 0730-1630 Eastern Time (ET) (Monday through Friday). All repairs shall be completed by no later than (NLT) 1630 ET the next weekday from initial notification.

5.1.7.3 Repair by exchange: All “repair by exchange” shall be approved in advance by the COR and/or BMET TL. Replacement(s) shall be sent to the MTF within 24 hours of malfunction/damage disposition. Replacement(s) must be the exact same part/model number, generation, and quality of equipment as the previous system prior to damage.

5.1.7.4 Response Time: Within one (1) hour of notification, Contractor technical personnel shall respond by telephone within the same day. If the equipment cannot be restored to the operating condition via telephone technical support, the Contractor personnel shall arrive onsite within one business day to complete the requested services or repair(s)once notified of unscheduled maintenance or repairs. The onsite response time is measured from the time the Contractor is originally called, not from the time the Contractor returns the call. Onsite responses will only be rendered under this contract during the hours of 0730 and 1630 Eastern Time (ET) (Monday through Friday). All repairs shall be completed by no later than (NLT) 1630 ET the next business day from initial notification.

5.1.7.5 Total annual platform and hands on technician time should not exceed 60 hours for Chemistry and 50 hours for Immunoassay.

5.1.7.6 Total combined daily maintenance should not exceed 15 minutes.

5.1.7.7 Total combined weekly maintenance should not exceed 25 minutes hands-on time.

5.1.7.8 Total combined monthly maintenance should not exceed 60 minutes hands-on time.

5.1.8 Documentation: The contractor shall monitor and document system performance, noting dates and times of notification of maintenance requests, type of request (emergency or routine Preventive Maintenance Inspection (PMI)), response times and completion of work. Records of performance shall be maintained and available for review by the Government.

At the completion of each PMI and emergency service call, the contractor shall provide the 6th MDG laboratory with an electronic service report to include:

Type of service; PMI, emergency service call.

Description of all services rendered during the visit.

Listing of any discrepancies that may still exist with any item on the contract.

Complete listing of replacement parts used by part number.

Completed service report shall be turned into the laboratory prior to the Contractor departing 6th MDG.

Furnish printed report of calibration and quality control results.

5.1.9 The Contractor Point of Contact (POC): The Contractor shall provide, in writing, the name and direct toll-free telephone number(s), and email address(es) of a primary and alternate, English-speaking, individual to act as their representative for the scheduling and coordination of service calls. The contractor’s POC must be available for service calls between the hours of 0730 and 1630 ET, Monday through Friday, excluding Government holidays.

5.1.10 Telephone Assistance: The Contractor shall provide telephone assistance between the hours of 0730 and 1630 ET, Monday through Friday, excluding Government holidays, for the chemistry platform covered under this contract. Telephone assistance shall be toll free to the Government and shall be made by a qualified repair technician. The contractor shall only accept calls from

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5.1.11 General Requirements: If the Contractor claims any service calls are a result of the Government, to include problems resulting from, but not limited to, unintentional damage, operator error, normal wear and tear, component part failures, environment issues (e.g., water damages), etc., the damages must be shown immediately to the 6th MDB laboratory leadership for verification before making repairs and to prevent further unintentional damages.

5.1.12 DELIVERABLES/SCHEDULE for Reagents and Consumables:

a) Cost Per Reportable Results (CPRR) Terms

i. The Government activity defines Cost per Reportable Results (CPRR) as actual inpatient or outpatient results reported to a provider.

ii. The CPRR for each of the analytes and volumes listed in Part 7, Attachment 2, must be inclusive of all reagents, standards, quality control, calibrators, linearity material and sample repeats for the committed year and include equipment usage, maintenance (both preventative maintenance and emergency repairs), accessories (probes/lamps, etc.), and consumables as calculated for the test volume, service, training, and shipping. Pricing must be established based on total estimated annual volume for each option year (if option year is applicable). This per patient reportable result shall also encompass all costs associated with dilution, repeat and confirmatory testing required to produce a single patient reportable result. It shall also include materials for calibration and correlation studies prescribed the Clinical Laboratory Standards Institute (CLSI-formerly NCCLS).

iii. Contractor provides a project manager to perform/oversee system installation, correlation and validation of the new systems. Contractor also provides all validation reagents/materials needed to complete system validation with a 30-day timeframe.

iv. The Government activity shall agree to print patient reportable results reports from the analyzers or the CHCS laboratory Information System on the first day of each calendar month and submit this report by the 5th business day of each month for billing purposes.

5.1.13 Administrative Support:

5.1.13.1 The contractor must deliver and complete the initial validation/comparison studies for each platform in accordance with College of American Pathologists regulations and any other state requirements, provide to the 6th Medical Group Laboratory a complete record of validation(s) upon complete installation of the platform. Platform installation shall be complete within 45 days of contract award. In addition to all requirements set by College of American Pathologists, the validation must include the following: analytical accuracy, analytical precision (including within run and day to day precision), reportable range, and pipette carry over (study or documentation).

5.1.13.2 The contractor shall administer all corrective action for failed performance during initial validation until rectified and IAW the College of American Pathologists requirements.

5.1.13.3 The contractor shall pay for all validation samples (i.e. Maine Standards or other commercial standards).

5.1.13.4 The Contractor shall customize the software to meet specific customer requirements at no additional cost.

5.1.13.5 The contractor shall…