Draft Performance Work Statement dated 22JUN2024.pdf

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NOTICE OF INTENT TO SOLE SOURCE AND SYNOPSIS - RALS Software License at BJACH
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This document is a Draft Performance Work Statement (PWS) for a service contract to provide an Information Technology (IT) connectivity solution for test result entry from Point of Care (POC) NOVA Glucose Analyzers into the MHS Genesis/Cerner system at Bayne Jones Army Community Hospital.

The key requirements are: the system must be Risk Management Framework (RMF) approved, have all functionality delivered on one screen, provide vendor neutral interfaces to all Glucose POC Devices, have a single LIS interface, provide bi-directional connectivity to all devices, have all results on a single shared server, and be approved for Authority to Operate (ATO) before contract award. The contractor shall provide RALS software licenses, educational materials, IT connectivity solution implementation, equipment replacement, and 24/7 telephone support. The contract period is from 1 October 2024 to 30 September 2029, with a potential 6-month extension. The North American Industry Classification System (NAICS) code is 541512 - Custom Computer Programming Services.

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Performance Work Statement Bayne-Jones Army Community Hospital (BJACH) Fort Johnson, Louisiana

Dated: 22 June 2024

Part 1

General Information

1. General: This is a non-personal service(s) contract under which the personnel rendering the service(s) 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.

1.1 Description of Services/Introduction: This is a non-personal service(s) contract to provide an Information Technology (IT) connectivity solution for the test results of Point of Care (POC) NOVA Glucose Analyzers entry into the MHS Genesis/Cerner at Bayne Jones Army Community Hospital.

1.2 Background: RALS software license is needed to support data from the I-STAT, Nova Glucose meter and other POC analyzers.

1.3 Scope: The Contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items necessary to perform services as described in the PWS and associated contract

1.4 Objectives:

• System must be Risk Management Framework (RMF) approved.

• All functionality delivered on one screen.

• Vendor neutral interfaces to all Glucose POC Devices

• Single LIS Interface

• Bi-Directional connectivity to all devices

• All results on a single shared server.

• Approved ATO before contract is awarded.

1.5 General Information:

1.5.1 Quality Control Plan (QCP): The Contractor shall develop and maintain a QCP to ensure services are performed in accordance with (IAW) this PWS. The Contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The Contractor's QCP is the means by which it assures that the work provided complies with the requirements of the contract.

The Contractor’s Proposed QCP shall be submitted to the Contracting Officer (KO) through the Contracting Officer’s Representative (COR) for review 10 days after date of contract award (Deliverable #1).

The Government will review and either notify the Contractor in writing of acceptance of the plan or return their comments to the Contractor within 10 days. If the Government has provided comments, the Contractor shall then have 3 days to submit a Final QCP.

After receipt of the Final QCP, the Contractor may receive the Contracting Officer’s acceptance in writing. Any proposed changes to the accepted QCP are required to be resubmitted for acceptance by the Contracting Officer no later than 10 days prior to the anticipated change and before implementation by the Contractor. The timeline noted above will apply for review and acceptance for proposed changes. At a minimum, the QCP must include and answer the following to be acceptable:

(a) A description of the inspection system to cover all incidental support and maintenance services listed on the Performance Requirements Summary (PRS).

Description shall include specifics as to the areas to be inspected on both a scheduled and unscheduled basis, frequency of inspections, and the title and organizational placement of the inspectors. Additionally, control procedures for any Government provided keys or lock combinations shall be included.

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

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

(d) How the Contractor will identify, investigate, and correct any non-conforming performance and prevent similar deficiencies in the future; and

(e) How the Contractor will file and save all Quality Control related documents for the life of the contract plus 5 years.

1.5.1.1 An Analysis of Quality Control and Timeliness of Submittals (i.e. deliverables) shall be provided to the COR within 30 days upon completion of each option period or Task Order (Deliverable #2).

1.5.1.2 The Contractor shall inform the COR of issues or potential issues that might affect the performance within 24 hours of identifying those issues. Verbal reports shall be followed up by written reports within 7 days (Deliverable #3).

1.5.2 Quality Assurance: The Government will evaluate the Contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP).

This plan is primarily focused on what the Government must do 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 acceptable quality levels (performance thresholds).

1.5.3 Recognized Holidays: The following provides information on recognized holidays for the purpose of the PWS. If submittal of any documentation (e.g.

deliverables, submittals, etc.) deadlines fall on a holiday, the closest work day prior to the holiday will apply as the deadline for submittal.

1.5.3.1 U.S. Holidays: Work shall not be performed on U.S. federally recognized holidays occurring during the normal workweek unless otherwise directed by the Contracting Officer. When a U.S. holiday occurs on a Saturday or a Sunday, the holiday is observed on the preceding Friday or following Monday, respectively.

New Year’s Day January 1st M. L. King Memorial Day 3rd Monday in Jan

Presidents Day 3rd Monday in February Memorial Day last Monday in May

Juneteenth June 19th Independence Day July 4th

Labor Day 1st Monday in September Columbus Day 2nd Monday in October

Veteran’s Day November 11th Thanksgiving Day 4th Thursday in November

Christmas Day December 25th

1.5.4 Operating Hours: The Government facility office hours, facility operating hours, and the Contractor support hour requirements often coincide, however, they may differ.

Please refer to the following.

1.5.4.1 Government Facility Office Hours: The Government facility office hours are 0800-1630 and Monday through Friday except U.S. Holidays identified in paragraph

1.5.3.1 above or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings.

1.5.4.2 Government Facility Operating Hours: The Government facility is open for operations during the recognized U.S. Holidays identified in paragraph 1.6.3.1 above.

The Government facility may close due to local or national emergencies, administrative closings, or similar Government directed facility closings and will be communicated by the Contracting Officer to the Contractor.

1.5.4.3 Contractor Support Hours: The Contractor shall provide support between the hours of 0800-1630 and the days of Monday through Friday except the closure of the facility during local or national emergencies, administrative closings, or similar Government directed facility closings. The Contractor shall maintain an adequate workforce at all times, for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce is essential.

1.5.4.3.1 Contractor Work Plan: The Contractor shall prepare and maintain a Work Plan. The plan, as a minimum, shall identify regularly scheduled work (to include location, work to be completed, timeline, etc.) The Contractor’s proposed Work Plan shall be submitted to the Contracting Officer via the COR for review within 10 days after date of contract award (deliverable #4). The Government will review and either accept or return their comments to the Contractor within 10 days. The Contractor shall then have 3 days to submit a Final Work Plan. Any proposed change to the accepted Final Work Plan is required to be resubmitted via the COR for review and acceptance by the Contracting Officer at a minimum thirty (30) days prior to implementation. The timeline noted above shall apply for review and acceptance for proposed changes.

1.5.5 Training Holidays: Fort Johnson has historically granted military personnel training holidays as compensation for time that they spent in field training. These are typically combined with regular holiday leave schedules (for example, Christmas half days or day on day off schedules). Training holidays may affect access to military operated facilities. If scheduled work or access to facilities is required, coordination with occupants will be necessary or the work in affected facilities shall be rescheduled after the training holiday. However, announced training holidays or exodus of military personnel may provide the Contractor with an opportunity for unrestricted access to facilities and areas. The Contractor shall take full advantage of such opportunities by planning maintenance or actions that are better accomplished when such areas are vacant.

1.5.6 Place of Performance: The work to be performed under this contract will be performed at

Bayne Jones Army Community Hospital Department of Pathology 1585 3rd St

Fort Johnson, LA 71459

1.6 Security Requirements: The following information is provided on security related matters.

1.6.1 Security Program: Contractor personnel performing work under this contract must undergo a successful security screening before being provided access to DoD information technology resources, and must maintain the level of security required for the life of the contract. The security requirements are IAW with the DoD Contract Security Classification Specification (DD Form 254), which is currently accessible at the following link: http://www.dtic.mil/whs/directives/forms/eforms/dd0254.pdf

1.6.2 Personnel Security Clearance Requirements: Contractor personnel performing work under this contract must have an active personnel security clearance in the Defense Information System for Security (DISS) at time of the proposal submission, and must maintain the level of security required for the life of the contract. The security requirements are IAW the DoD Contract Security Classification Specification DD Form 254.The Contractor shall ensure that Contractor employees and subcontractor employees performing services under this contract comply with FAR 52.204-2 Security Requirements when the employee has access to information classified “Confidential,” “Secret,” or “Top Secret.” The Contractor shall ensure the employee complies with the DoD Security Agreement (DD Form 441), and the NISPOM rule at 32 Code of Federal Regulation (CFR) Part 117, effective 24 Feb 2021. The NISPOM is the National Industrial Security Program Operating Manual to which contractors must implement and comply.

1.6.3 Installation Access: Access to U.S. installations, buildings and controlled areas is limited to personnel who meet security criteria and are authorized. Failure to submit required information/data and obtain required documentation or clearances will be grounds for denying access to U.S. installations, buildings and controlled areas. The Contractor shall ensure that any subcontractors used in performance of this contract complies with these requirements and that all employees, of both the Contractor and any subcontractor utilized by the Contractor, are made aware of and comply with these requirements.

The Contractor shall be aware of and comply with the requirements associated with Installation Access Control. The Government is not liable for any costs associated with performance delays due solely to a firm’s failure to comply with Installation Access Control System (IACS) processing requirements.

The Contractor shall return installation passes to the issuing IACS office when the contract is completed or when a Contractor employee no longer requires access.

All unescorted visitors to Fort Johnson must be vetted at the Visitors Center, located adjacent to the main gate on Louisiana Avenue (building 5903). Personnel requiring unescorted access will present a state issued Real ID Act compliant driver’s license (check status of your state at: https://www.dhs.gov/real-id-enforcement-brief).

Visitors who do not have a Real ID act compliant driver’s license may use alternate forms of ID to proof their identity. Contact the Fort Johnson Visitor’s Center at (337) 531-7907 to obtain a listing of authorized alternate forms of identity. Each visitor with acceptable screening results will be issued an access control credential for unescorted access to the installation. Personnel with unfavorable screening results may be denied unescorted access to Fort Johnson. Law enforcement data obtained during the vetting process will not be released by personnel at the Visitors Center. A http://www.dtic.mil/whs/directives/forms/eforms/dd0254.pdf waiver process has been established for personnel who are denied unescorted access. Generally, waivers will be processed within five days of completion.

Escorted visitors who are accompanied by Department of Defense-affiliated personnel (active-duty Soldiers, civilian common access card holders, retiree ID card holders, DoD dependent ID card holders, and civilian contractor CAC holders) will not require vetting for access and will only need to produce a valid ID card; these visitors must be in the immediate vehicle of the escorting card holder. DoD affiliated personnel will be responsible for their escorted visitors on the installation. Personnel who are enrolled and vetted through the Rapid Gate program or possess an installation issued ID/Pass do not have escorting privileges.

The Fort Johnson Visitors Center is open 24 hours a day, seven days per week. For additional information concerning access control please contact the Visitors Center at (337) 531-0380/4978/7186.

1.6.3.1 Physical Security: The Contractor shall safeguard 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 IAW the Army Physical Security Program (AR 190-13.”)

1.6.3.2 Operations Security (OPSEC) Requirements: Contractor personnel shall adhere to facility security policies and restrictions. The Contractor shall immediately report suspicious activities to security personnel. Government issued access badges shall not be worn outside designated facilities where visible to the general public.

1.7 Post Award Conference/Periodic Progress Meetings: The Contractor shall attend any post award conference convened by the contracting activity or contract administration office in accordance with FAR Subpart 42.5. The Contracting Officer, COR, and other Government personnel, as appropriate, may meet periodically with the Contractor to review the Contractor's performance. At these meetings the Contracting Officer will apprise the Contractor of how the Government views the Contractor's performance and the Contractor shall apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the Government.

1.7.1 The Contractor shall attend, participate in, and furnish input to scheduled and unscheduled meetings, conferences, and briefings that relate to the functions and services herein as required by the Government to provide effective communication and impart necessary information. The Contract Manager or designated representative shall attend meetings as requested by the Government. Meeting attendees shall at times include Contractor managerial, supervisory, and other personnel knowledgeable of the subject matter. Meetings may start or end outside of regular duty hours.

1.8 Contracting Officer’s Representative (COR): Refer to Part 2 of this PWS for the definition of a COR. As determined by the Contracting Officer, a COR will be appointed and identified by letter of designation, a copy of which will be provided to the Contractor by the Contracting Officer. The designation letter states the responsibilities and limitations of the COR, especially with regard to 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 order. The COR monitors all technical aspects of the contract and assists in contract administration. The COR is not authorized to obligate the Government. If the work is not written in the contract, the COR is not authorized to request new work. 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 Contracting Officer and Contractor of any deficiencies, coordinate availability of Government property, and coordinate site entry of Contractor personnel.

1.9 Key Personnel: The following personnel are considered key personnel by the Government: Program/Contract Manager/Alternate Program/Contract Manager, Quality Control Manager, Systems Administrator, etc. The Contractor shall provide a Program/Contract Manager who shall be responsible for the performance of the work.

The name of this person and an Alternate Program/Contract Manager, who shall act for the Contractor when the Program/Contract Manager is absent, along with a Curriculum Vitae (CV) for each of these individuals, shall be provided in writing to the Contracting Officer no later than 5 days after contract award. The Contract Manager and Alternate Contract Manager shall have full authority to act for the Contractor on all contract matters relating to daily operation of this contract. The Contract Manager or Alternate Contract Manager shall be available between 0800 to 1630, Monday through Friday.

Qualifications for all key personnel are listed below:

a. Contract Manager and Alternate Contract Manager: The CV provided by the Contract Manager and Alternate Contract Manager must demonstrate successful completion of 24 semester hours in mathematical, engineering, and quantitative analysis courses; 15 or more years cost analysis experience; and familiarity with Defense Department Data Sources (e.g. cost and software data reporting, Earned Value Management (EVM), etc.) or must demonstrate a minimum of 5 years’ experience within the past 10, working as a Program Manager.

b. Quality Control Manager: The Quality Control Manager must demonstrate a minimum of 5 years’ experience, within the past 10, working as a Quality Control Manager.

c. Systems Administrator: The Systems Administrator must demonstrate a minimum of 5 years’ experience, within the past 10, working as a Systems Administrator.

d. Special Qualifications: The Contractor shall ensure all employees possess and maintain current Information Assurance Technician (IAT) Level I professional certification during the execution of this contract.

1.10 Identification of Contractor Employees: All Contractor personnel attending meetings, answering Government telephones, and working in other situations where their Contractor status is not obvious to third parties must identify themselves, to include proper marking of signature blocks in correspondence, to avoid creating an impression in the minds of members of the public that they are Government officials. The Contractor shall ensure that all documents or reports, produced by Contractors are suitably marked as Contractor products or that Contractor participation is appropriately disclosed.

1.11 Contractor Identification Badges: Contractor personnel shall be easily identifiable through the display of badges IAW Contractor Identification (AE Reg. 27-715). (For services at Child, Youth, and School Services where children are present, recommend personnel wear identification when children are present.) The Contractor (to include subcontractors) shall provide each of their employees an easily readable identification badge. The badge must include the employee’s name, the contractor’s company name, the functional area of assignment, and a recent color photograph of the employee.

Companies with U.S. Government contracts will require their employees to wear these badges visibly when performing work at Government workplaces unless this would be impractical because of mission or safety considerations. The Contractor shall collect all ID Badges upon completion of the contract or termination of employee. A listing of issued ID cards shall be furnished to the Contracting Officer prior to the contract performance date and updated as needed to reflect Contractor personnel changes.

1.12 Data Rights: The Government has unlimited rights to all documents and materials produced under this contract. All documents and materials, to include the source codes of software, produced under this contract shall be Government owned and are the property of the Government with all rights and privileges of ownership and copyright belonging exclusively to the Government. These documents and materials may not be used or sold by the Contractor without written permission from the Contracting Officer.

All materials supplied to the Government shall be the sole property of the Government and may not be used for any other purpose. This right does not abrogate any other Government rights.

1.13 Non-Disclosure Requirements: Performance under this contract may require the Contractor to access data and information proprietary to a Government agency, another

Government Contractor, or of such nature that its dissemination or use other than as specified in this work statement would be adverse to the interests of the Government or others. The Contractor and Contractor personnel shall not divulge, or release data or information developed, or obtained under performance of this PWS, except to authorized Government personnel or upon written approval of the Contracting Officer.

The Contractor shall not use, disclose, or reproduce proprietary data, which bears a restrictive legend, other than as specified in this PWS. All documentation showing individual names or other personal information shall be controlled and protected under the provisions of the Privacy Act of 1974, Public Law 93-579, 5 United States Code (U.S.C.) Section 552a.

1.14 Protection of Government and Contract Information: Per Public Use Notice of Limitations stated by Defense imagery Management operations Center and contained at www.dimoc.mil/resources/limitations/ , the Contractor shall not cite any information (e.g., contract information, pictures, locations, etc.) obtained through this contract on any hard copy or digital marketing tools to include its company website.

1.15 Non-Disclosure Statements: The Contractor shall provide signed non-disclosure agreements to the Government no later than 10 days (deliverable # 5) prior to commencement of work under the contract. Disclosure of information by Contractor personnel may result in removal of Contractor personnel from performance under this contract.

1.16 Organizational Conflict of Interest (OCI): Contractor and subcontractor personnel performing work under this contract may receive, have access to or participate in the development of proprietary or source selection information (e.g., cost or pricing information, budget information or analyses, specifications or work statements, etc.) or perform evaluation services which may create a current or subsequent OCI as defined in FAR Subpart 9.5. The Contractor shall notify the Contracting Officer immediately whenever it becomes aware that such access or participation may result in any actual or potential OCI and shall promptly submit a plan to the Contracting Officer to avoid or mitigate any such OCI (deliverable #6). The Contractor’s OCI Mitigation Plan will be determined to be acceptable solely at the discretion of the Contracting Officer. In the event the Contracting Officer unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, the Contracting Officer may affect other remedies as he or she deems necessary, including prohibiting the Contractor from participation in subsequent contracted requirements which may be affected by the OCI.

http://www.dimoc.mil/resources/limitations/

PART 2

DEFINITIONS & ACRONYMS

2. Definitions and Acronyms

2.1 Definitions: Although not inclusive of every term used within this PWS, the following provides a list of definitions used throughout this PWS and commonly used in the acquisition field.

Contracting Officer – means a person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings on behalf of the Government. Note: The only individual who can legally bind the Government.

Contracting Officer's Representative (COR) – As defined in DFARS 202.101, means an individual designated and authorized in writing by the Contracting Officer to perform specific technical or administrative functions. DoD Instruction (DoDI) 5000.72, Part II Definitions states the following when defining a COR: “Defined in subpart 202.101 of Reference (f). Any individual delegated responsibilities pursuant to subpart 1.602-2 of Reference (e), regardless of local terminology, must be certified in accordance with this instruction. For example, local terminology can be COR, Contracting Officer’s technical representative, technical point of contact, technical representative, alternate COR, administrative COR, assistant COR, line item manager, task order manager, quality assurance personnel, quality assurance evaluator, or COR management.” In addition, Army Regulation 70-13, Chapter 2, paragraph 2-2g, states, in part, the following when providing other surveillance support personnel to assist the COR when needed, “…These other surveillance support personnel may serve as on-site representatives of the COR in performance of actual contract surveillance if they meet all COR requirements and have been appointed by the Contracting Officer as alternate CORs.”

Contractor – means a supplier or vendor awarded a contract to provide specific supplies or service to the Government. The term used in this contract refers to the prime.

Contractor-acquired Property - means property acquired, fabricated, or otherwise provided by the Contractor for performing a contract and to which the Government has title.

Day – means, unless otherwise specified, a calendar day.

Defective Service – means a service output that does not meet the standard of performance associated with the Performance Work Statement.

Deliverable – means anything that can be physically delivered, but may include non-manufactured things such as meeting minutes or reports.

Government-furnished Property – As reflected in FAR 52.245-1, Government-furnished Property “means property in the possession of, or directly acquired by, the Government and subsequently furnished to the Contractor for performance of a contract. Government-furnished property includes, but is not limited to, spares and property furnished for repair, maintenance, overhaul, or modification. Government-furnished property also includes contractor-acquired property if the contractor-acquired property is a deliverable under a cost contract when accepted by the Government for continued use under the contract

Government Property - means all property owned or leased by the Government.

Government property includes both Government-furnished and Contractor-acquired property. Government property includes material, equipment, special tooling, special test equipment, and real property. Government property does not include intellectual property and software.

Property Administrator - means an authorized representative of the Contracting Officer appointed in accordance with agency procedures, responsible for administering the contract requirements and obligations relating to Government property in the possession of a Contractor.

High Level Objective (HLO) – means a key overarching result-based objective for a project necessary to achieve the project’s vision. HLOs are similar to Level 2 in a Work Breakdown Structure. Each HLO may contain several statements to flesh out the areas necessary to meet the objective.

Physical Security – means that part of security concerned with physical measures designed to safeguard personnel; to prevent unauthorized access to equipment, installations, material, and documents; and to safeguard against espionage, sabotage, damage, and theft.

Quality Assurance – (or Government contract quality assurance) means the various functions, including, inspection, performed by the Government to determine whether a Contractor has fulfilled the contract obligations pertaining to quality and quantity.

Quality Assurance Surveillance Plan (QASP) – means the key Government-developed surveillance process document and is applied to Performance-Based Service Contracting (PBSC). The QASP is used for managing Contractor performance assessment by ensuring that systematic quality assurance methods validate that Contractor quality control efforts are timely, effective, and are delivering the results specified in the contract or task order. The QASP directly corresponds to the performance objectives and standards (i.e., quality, quantity, timeliness) specified in the Performance Work Statement (PWS). It provides specific details on how the Government will survey, observe, test, sample, evaluate, and document Contractor performance results to determine if the Contractor has met the required standards for each objective in the PWS. The QASP, with very few if any exceptions, is an internal to Government document.

Quality Control – means all necessary measures taken by the Contractor to assure that the quality of an end product or service shall meet contract requirements.

Statement – means the specific results-based activities required to satisfy HLOs. A statement contains a result, the context of the statement, and the required action(s).

Statements focus on “what” is to be accomplished; however they are not prescriptive in describing “how” the outcome is to be achieved. Each HLO may have several statements to flesh out the areas necessary to meet the objective. Statements are similar to Level 3 in a Work Breakdown Structure.

Subcontractor – means one that enters into a contract with a prime Contractor. The Government does not have privity of contract with the subcontractor.

Work Day - The number of hours per day the Contractor provides services in accordance with the contract.

Work Week - Monday through Friday, unless otherwise specified.

2.2 Acronyms: Although not inclusive of every term used within this PWS, or that may be included in an acquisition, the following provides a list of acronyms commonly used in the acquisition field.

ACOR Alternate Contracting Officer's Representative

AE Army in Europe

AFARS Army Federal Acquisition Regulation Supplement

AHA Activity Hazard Analysis

AOR Area of Responsibility

AR Army Regulation

AT Anti-terrorism

ATCTS Army Training Certification Tracking System

CAC Common Access Card

CCE Contracting Center of Excellence

CFE Conventional Forces Europe

CFR Code of Federal Regulations

CONUS Continental United States (excludes Alaska and Hawaii)

COR Contracting Officer’s Representative

COTS Commercial-Off-the-Shelf

DA Department of the Army

DD250 Department of Defense Form 250 (Receiving Report)

DD254 Department of Defense Contract Security Requirement List

DFARS Defense Federal Acquisition Regulation Supplement

DMDC Defense Manpower Data Center

DoD Department of Defense

FAR Federal Acquisition Regulation

FRG Federal Republic of Germany

GFP Government Furnished Property

HLO High Level Objective

HIPAA Health Insurance Portability and Accountability Act of 1996

IA Information Awareness

IAC Installation Access Control

IACO Installation Access Control Office

ID Identification

IGCE Independent Government Cost Estimate

IT Information Technology

JTR Joint Travel Regulation

JPAS Joint Personnel Adjudication System

KO Contracting Officer

OCI Organizational Conflict of Interest

OCONUS Outside Continental United States (includes Alaska and Hawaii)

ODC Other Direct Costs

OPSEC Operations Security

PA Property Administrator

PII Personally Identifiable Information

PIPO Phase In/Phase Out

POC Point of Contact

PRS Performance Requirements Summary

PWS Performance Work Statement

QA Quality Assurance

QAP Quality Assurance Program

QASP Quality Assurance Surveillance Plan

QC Quality Control

QCP Quality Control Program

RA Requiring Activity

RCO Regional Contracting Office

SIGE Safety and Health Protection Plan

TE Technical Exhibit

USAG United States Army Garrison

USAREUR United States Army Europe UOM Unit of Measure

PART 3

SPECIFIC TASKS

3.1 Basic Services: The contractor shall provide the point of care software license to provide an Information Technology (IT) connectivity solution for test result entry into the MHS Genesis system. IT solutions must be able to support data from the I-STAT, Nova StatStrip Glucose meter and AVOXIMETER 4000. The Contractor shall provide all educational materials & literature, Inpatient IT connectivity solution with MHS Genesis, equipment replacement, and system implementation.

5.2 Tasks: Tasks consist of the following:

(a) Software shall collect test results from devices used every day at the point of care (POC) and provide access from anywhere/anytime with full functionality.

(b) Software shall manage all QCs in a single system and can lockout the system when QC expires.

(c) Software shall manage all operators’ competency in a single system and can lockout the system when competency expires.

(d) Software shall ensure point of care testing (POCT) Admin see or track what users are doing through the network.

(e) The contractor shall provide method validation for data transfer to ensure all patient data and test results transferred from the POC instrument to the MHS Genesis system are accurate.

(f) The contractor shall provide telephone support to the operators for instrument management and troubleshooting 7 days a week, 24 hours a day.

(g) The contractor shall provide all data and material to verify the analytical measurement range.

(h) The contractor shall provide at least one electronic quiz of competency assessment to each individual operator per fiscal year (BJACH currently has approx.180 operators) without extra cost to the government.

(i) The Contractor shall provide initial on-site operator training to two (2) primary operators assigned to the Government site (i.e., BJACH Laboratory staff) prior to initiation of use of the software for patient testing at no cost to the Government. The training shall encompass basic operation, maintenance and troubleshooting.

PART 4

APPLICABLE PUBLICATIONS

4. Applicable Publications (Current Editions): The following publications, manuals, regulations, etc. are mentioned in this PWS and are listed below.

4.1.1 Department Of Defense Contract Security Classification Specification (DD Form 254)

4.1.2 Department of Defense Security Agreement (DD Form 441)

4.1.3 National Industrial Security Program Operating Manual (DoD 5220.22-M)

4.1.4 Installation Access Control (AE Reg 190-16)

4.1.5 The Army Physical Security Program (AR 190-13)

4.1.6 Contractor Identification (AE Reg 27-715)

4.1.7 U.S. Army Corps of Engineers Safety and Health Requirements Manual (EM 385-1-1)

4.1.8 Information Assurance Workforce Improvement Program (DoD 8570-M)

4.1.9 Information Assurance Training Certification and Workforce Management Directive (DoDD 8570.01)

4.1.10 Information Assurance (AR 25-2)

4.1.11 Electromagnetic Compatibility Directive (2004/108/EC)

4.1.12 Policies and Procedures for Property Accountability (AR 735-5)

PART 5

ATTACHMENT AND TECHNICAL EXHIBIT LISTING

5. Attachment and Technical Exhibit List

5.1 Technical Exhibit A – Performance Requirements Summary

5.2 Technical Exhibit B – Deliverables Schedule

TECHNICAL EXHIBIT A

Performance Requirements Summary (PRS)

PERFORMANCE

REQUIREMENT

PERFORMANCE

STANDARD

PERFORMANCE LEVEL SURVEILLANCE

METHOD

1. QC/Competency lockout when QC or/and operator’s competency expires. SOW section 5.2.b. & 5.2.c.

Software locks out the system when QC or/and operator’s competency expires

Zero Deviation from Standard

100% Inspection

2. Method Validation for data transfer. SOW section 5.2.e

Method Validation for data transfer will be conducted in accordance with method validation protocols established by the Department of Pathology's Quality

100% accuracy in each performance period.

3. Contractor shall provide telephone support.

SOW section 5.2.f.

Provides telephone support 7 days a week, 24 hours a day.

99% based on the number of calls placed each month.

Periodic Inspection

4. The contractor shall provide all data and material to verify analytical measurement range. SOW section 5.2.g

Provides data and for verification of measurements range as required.

100% Compliance

5. Contractor shall provide electronic quiz of competency assessment to operators.

SOW section 5.2.h.

Provides one electronic quiz for each individual operator’s competency assessment per fiscal year without extra cost to the government.

6. Provide initial on-site operator training to primary operators.

SOW section 5.2.i.

Provide initial on-site operator training to two (2) primary operators assigned to the Government site (i.e., BJACH Laboratory staff) prior to initiation of use of the software for patient testing at no cost to the Government.

TECHNICAL EXHIBIT B

DELIVERABLES SCHEDULE

Deliverable Frequency # of Copies Medium/Format Submit To #1

Quality Control Plan (paragraph 1.5.1)

Once within 10 days after contract award and no later than 30 days prior to any anticipated changes.

One each to the Contracting Officer

Electronic delivery via email using Microsoft Office Word or Power Point 2013

To the Contracting Officer through the Contracting Officer’s Representati ve (COR)

#2

Analysis of Quality Control and Timeliness of Submittals (paragraph 1.5.1.1)

Once within 30 days upon completion of each option period or Task Order

One each to the COR

Electronic delivery via email using Microsoft Office

To the COR

#3

Written reports for issues that might affect the performance (paragraph 1.5.1.2)

Once within 7 days after verbal report

One each to the COR

Electronic delivery via email using Microsoft Office

To the COR

#4

Contractor Work Plan(Paragraph 1.5.4.3.1)

Once within 10 days after contract award and no later than 30 days

Officer

Electronic delivery via email using Microsoft Office

Officer through the

COR

Deliverable Frequency # of Copies Medium/Format Submit To #5

Non-disclosure statement (Paragraph 1.15)

Once within 10 days after contract award and no later than 30 days

Officer

Electronic delivery via email using Microsoft Office

Officer

#6 Organizational Conflict of Interest (OCI) (Paragraph 1.16) immediately whenever it becomes aware of any actual or potential OCI

One each to the Contracting Officer

Electronic delivery via email using Microsoft Office

Officer

File details come from the government source that posted it. Updated .