MediaLab_ Performance Work Statement.pdf

PERFORMANCE WORK STATEMENT (PWS)

FOR USE OF Cloud-Based Software for the Lab

1. GENERAL: The Department of Pathology and Area Laboratory Services is requesting a site license for cloud-based software in line with FedRAMP moderate authorization for up to

150 users across ten (10) clinical sites to be used at Dwight D. Eisenhower Army Medical

Center (DDEAMC), Fort Eisenhower, GA.

1.2 Background: Cloud-based software manages for clinical laboratories, document control, inspection readiness, compliance education, laboratory personnel documentation and Continuing

Education (CE) requirements.

1.3 Objectives: The procurement of cloud-based software will enhance and sustain the

Department of Pathology’s inspection readiness, compliance education and document control requirements. Overall, this software enables the department to organize and facilitate our accreditation with The Joint Commission, the College of American Pathologists and the

Association for the Advancement of Blood and Biotherapies.

1.4 Period of Performance: This contract entails a 5-year software subscription starting from the date of execution of the license. This contract will include one base year and four Option

Years (OYs).

Base Year: 21 August 2026 through 20 August 2027

Option Year One (1): 21 August 2027 through 20 August 2028

Option Year Two (2): 21 August 2028 through 20 August 2029

Option Year Three (3): 21 August 2029 through 20 August 2030

Option Year Four (4): 21 August 2030 through 20 August 2031

1.5 Quality Control: The contractor shall develop and maintain an effective quality control program (QCP) to ensure services are performed in accordance with this PWS. The contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The contractor’s quality control program is how they assure that work complies with the requirement of the contract. The QCP is to be delivered within 30 days after the contract has been awarded. After acceptance of the quality control plan the contractor shall receive the contracting officer’s acceptance in writing of any proposed change to his QC system.

1.6 Quality Assurance: The government shall evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan. 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 minimum acceptable defect rate(s).

According to the Inspection of Services clause, the U.S. Government will evaluate the contractor's performance under this contract. For those tasks listed on the performance requirements summary (PRS), the contracting officer’s representative (COR) or evaluators will follow the methods of surveillance specified in this contract. U.S. Government personnel will record all surveillance observations. The initialing of the observation does not necessarily constitute concurrence with the observation, only acknowledgment that he or she has been made aware of the defective performance. U.S. Government surveillance of tasks not listed in the PRS or by methods other than those listed in the PRS (such as provided for by the Inspection of

Services clause) may occur during the performance period of this contract. Such surveillance will be done according to standard inspection procedures or other contract provisions. Any action taken by the contracting officer because of surveillance will be according to the terms of this contract.

1.6.1 Performance Evaluation Meetings: The contracting officer may require the contract manager to meet with the contracting officer, contract administrator, COR, and other U.S.

Government personnel as deemed necessary. The contractor may request a meeting with the contracting officer when he or she believes such a meeting is necessary. Written minutes of any such meetings shall be recorded in the contract and signed by the contract manager and the contracting officer or contract administrator. If the contractor does not concur with any portion of the minutes, such nonoccurrence shall be provided in writing to the contracting officer within 10 calendar days following receipt of the minutes.

1.7 Records: The contractor shall be responsible for creating, maintaining, and disposing of only those U.S. Government required records. For the purposes of this contract, required records include documentation management, incident and event management, competency assessment, personnel documentation, continuing education, and analytics and performance management. If requested by the U.S. Government, the contractor shall provide the original record or a reproducible copy of any such record within 5 working days of receipt of the request. A copy of all maintenance and validation records will be left by the technician in a folder by the analyzer.

1.8 HOURS OF OPERATION:

1.8.1 Normal Hours of Operation: The contractor shall perform the services required under this contract during the following hours: Monday through Friday between the hours of 0730 – 1630

EST except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings.

1.8.2 The contractor shall provide direct customer service and support during normal business hours.

1.8.3 Recognized Holidays:

Services shall not be required on Federal holidays or the day of observance of federally established holidays and local base holidays. In general, federal holidays falling on a Saturday are observed on the preceding Friday whereas holidays falling on a Sunday are observed on the following Monday. Additional federal holidays as authorized by the President of the United

States and/or executive orders shall be considered part of standard Federal Government holidays.

• Government Escort. If no Government employee is unavailable to provide required escort services during routine maintenance or system outages, the

COR shall assume escort responsibilities or provide alternate escort arrangements. The Contractor shall not remain on site without a required escort and shall follow all instructions issued by the KO or COR.

• In the event of a Government shutdown, the Contractor shall contact the COR to receive guidance. The Contracting Officer may issue a Stop-Work Order in accordance with FAR 52.242-15 if services under this contract are deemed non-essential.

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

Dwight D. Eisenhower Army Medical Center (DDEAMC)

Building 300 East Hospital Road

Fort Gordon, GA 30805-5650

2. CONSERVATION OF UTILITIES: N/A

3. CONTRACTOR PERSONNEL:

3.1 Contract Manager. The contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person, and an alternate or alternates, who shall act for the contractor when the manager is absent, shall be designated in writing to the contracting officer.

3.2 The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract.

3.3 The contract manager or alternate shall be available during normal duty hours (0730-1630

Eastern Standard Time Zone (EST)) within 24hrs to meet on the installation with U.S. Government personnel (designated by the contracting officer) to discuss problem areas. After normal duty hours, the manager or alternate shall be available within 48 hours.

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

3.5 Contractor personnel shall present a neat, business-like appearance and be easily recognized as contractor employees. Contractor personnel shall either wear a distinguishable uniform or badge on the exterior of their clothing while performing any service at any U.S. Government facility.

3.6 The contractor shall not employ any person who is an employee of the U.S. Government if employing that person would create a conflict of interest. Additionally, the contractor shall not employ any person who is an employee of the Department of Defense, either military or civilian, unless such person seeks and receives approval according to DOD 5500.7R, “Joint Ethics

Regulation”. The contractor shall not employ any person who is an employee of the Department of Defense if such employment would be contrary to local policies.

3.7 The contractor is cautioned that off-duty active military personnel hired under this contract may be subject to permanent change of station, change in duty hours, or deployment. Military

Reservists and National Guard members may be subject to recall to active duty. The abrupt absence of these personnel could adversely affect the contractor's ability to perform; however, their absence at any time shall not constitute an excuse for nonperformance under this contract.

4. SECURITY REQUIREMENTS:

4.1 Access and General Protection/Security and Procedures: This standard language text is for contractor employees with an area of performance within an Army controlled installation, facility or area. Contractor and all associated sub-contractors’ employees shall comply with applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative). The contractor shall also provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services or Security

Office. Contractor workforce must comply with all personal identity verification requirements directed by DOD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

Contractor personnel performing work under this contract must have regulatory requirements as defined by NIST SP 800-53, Control PS-3 (Personnel Screening). For a Moderate baseline, personnel must undergo background checks and suitability screening (typically a Tier 1 or Tier 2 investigation, leading to a Public Trust position).

4.2 Contractor Employees Who Require Access to Government Information Systems. All contractor employees with access to a government info system must be registered in the ATCTS

(Army Training Certification Tracking System) at commencement of services and must successfully complete the DOD Information Assurance Awareness prior to access to the information systems and then annually thereafter.

4.3 Physical Security: The contractor shall be responsible for safeguarding all U.S. Government property provided for contractor use or access.

4.4 Contracting Officer Representative (COR): The (COR) will be identified by separate letter.

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 Contracting Officer 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 order.

4.6 Organizational Conflict of Interest: 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 Organizational Conflict of Interests (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. The

Contractor’s mitigation plan will be determined to be acceptable solely at the discretion of the

Contracting Officer and 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.

5. DEFINITIONS/ACRONYMS:

5.1 DEFINITIONS. Following is a list of basic definitions.

5.2 CONTRACTING OFFICER: A person with the authority to enter, administer, and/ or terminate contracts and make related determinations and findings.

5.3 CONTRACTING OFFICER'S REPRESENTATIVE (COR): A U.S. Government employee selected and designated in writing by the Contracting Officer to act as his/her designated representative in administering a contract.

5.4 QUALITY ASSESSMENT AND IMPROVEMENT. Those actions taken by the U.S.

Government to check services to determine if they meet the requirements of the CLIA/DoD CLIP

’88 & ’03, CAP, JCAHO, U.S. Army Medical Command, quality assurance and risk management program and ensure compliance with the terms and conditions of the contract

5.5 QUALITY CONTROL. Those actions taken by a contractor to control the performance of services to ensure that they meet the requirements of the contract.

5.6 SERVICES: Includes services performed and materials furnished or utilized in the performance of those services

5.7 QUALITY IMPROVEMENT (QI): Those actions taken by the U.S. Government, in accordance with AR 40-68, to assure services meet the requirements of the Performance Work

Statement (PWS).

5.8 ACRONYMS/ ABBREVIATIONS. Following is a list of basic acronyms/abbreviations used in the contract.

ACOR Alternate Contracting Officer's Representative

AFARS Army Federal Acquisition Regulation Supplement

AR Army Regulation

CCE Contracting Center of Excellence

CFR Code of Federal Regulations

CONUS Continental United States (excludes Alaska and Hawaii)

COR Contracting Officer Representative

COTR Contracting Officer's Technical 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

HIPAA Health Insurance Portability and Accountability Act of 1996

KO Contracting Officer

OCI Organizational Conflict of Interest

OCONUS Outside Continental United States (includes Alaska and Hawaii)

ODC Other Direct Costs

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

TE Technical Exhibit

6. U.S. GOVERNMENT FURNISHED FACILITIES, EQUIPMENT, MATERIAL, AND

SERVICES:

6.1 EQUIPMENT. No equipment will be provided

6.2 MATERIALS. No materials will be provided.

6.3 SERVICES. The U.S. Government will not provide services.

6.4 UTILITIES. The U.S. Government will provide the standard range of utilities, electricity, water, heating, refuse collection, etc., as is provided other personnel as required.

6.5 Security Police and Fire Protection, as is provided by DDEAMC.

6.6 Emergency Healthcare for Contractor employees. The MTF will provide emergency healthcare for injuries occurring while on duty. The contractor shall reimburse the U.S.

Government for such services.

7. CONTRACTOR FURNISHED PROPERTY:

7.1 General. Except for those U.S. Government furnished items and services specified in section

3, the Contractor shall furnish all items and services required under this contract.

7.2 Transportation. Transportation is the responsibility of the Contractor. The U.S. Government will not provide transportation.

7.3 Nametags. The contractor shall furnish a nametag to each contract employee. The nametag will contain the name of the company and the employee.

7.4 CONTRACTOR MANAGEMENT REPORTING (CMR): The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract via a secure data collection site. The contractor is required to completely fill in all required data fields using the SAM.gov website (https://sam.gov).

Reporting inputs will be for the labor executed during the period of performance during each

Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year.

8. SPECIFIC TASKS:

8.1 DESCRIPTION: The contractor shall provide and permitting a full cloud service access across up to 150 users. This subscription must grant full cloud service access across ten (10) clinical sites, which initially include the DDEAMC Main Lab, Connelly Health Clinic, Blood Donor Center, Rodriguez Army Clinic Lab, and SOUTHCOM Clinical Labs, plus their respective inspection sites. The software must feature an Intelligent Quality Engine (IQE) and a module for electronically storing education and certification documents. The subscription must also include all necessary technical support, unscheduled maintenance, and software updates.

8.1.1 The Contracting Officer will coordinate a site visit to the DDEAMC Department of

Pathology (Building 300, Room 1F-08). The purpose of this visit is to survey and assess the current laboratory configuration, environmental controls, and available utilities to ensure suitability for instrument placement.

8.2. MAINTENANCE AND SERVICE:

8.2.1 MAINTENANCE: The contractor shall be responsible for furnishing maintenance, services, repairs, and parts as required to maintain the system in optimal operating condition.

8.2.2 The contractor shall provide all services and personnel necessary to maintain server availability, perform scheduled software updates, and execute necessary system maintenance.

https://www.google.com/url?q=https%3A%2F%2Fsam.gov

Contractor personnel shall perform all system updates, security patches, and routine maintenance in accordance with system documentation and industry best practices. Services shall include troubleshooting, resolving system errors, and providing remote technical support to assist system users.

8.2.3 All work shall be performed in a professional manner by an authorized service representative.

If any deficiencies are found due to negligence of the service representative, the contractor shall be required to correct the deficiency to a fully operational status in accordance with manufacturer specifications at no additional cost to the U.S. Government.

8.2.4 The contractor shall notify the Point of Contact of the exact date and time for performance of a preventive maintenance service within ten (10) business days prior to the scheduled preventive maintenance services.

8.2.5 Smoking is prohibited within DDEAMC and its clinics.

8.3 TRAINING:

8.3.1 Training shall include basic operation, troubleshooting procedures, performance of operator-level periodic preventive maintenance procedures, and use of the data management/ quality control software.

8.3.2 Employee Training. All contractor training will be furnished by the contractor at no expense to the U.S. Government.

8.4 DELIVERY OF EQUIPMENT: N/A

8.5 LOCATIONS OF COMPLETE SERVICES:

8.5.1. Dwight David Eisenhower Army Medical Center (DDEAMC):

Software shall be utilized at:

DDEAMC

ATTN: MCHF-PAT

Building 300, East Hospital Rd

Fort Gordon, GA 30805-5650

8.5.2. Point of Contact

Contracting Officer’s Representative (COR)

Department of Pathology, Quality Assurance Manager

Tel: (706) 787-4765; DSN: 773-4765

9. APPLICABLE TECHNICAL ORDERS, SPECIFICATIONS, REGULATIONS, AND

MANUALS:

9.1 GENERAL. Applicable documents - The latest local and national (US) technical regulations are applicable for the manufacturing of the system. In case of differences between local and national regulations, the regulations containing the most stringent requirements shall govern.

Contractor will comply with all U.S. laws pertaining to medical equipment. Contractor will also comply with all Department of Defense (DOD), Department of Army (DA), US Army Medical

Command (USAMEDCOM), Southern Regional Medical Command and Dwight David

Eisenhower Army Medical Center regulations and policies pertaining to medical equipment.

9.2. The Publications have been coded as mandatory or advisory. The contractor is obligated to follow those coded as mandatory only to the extent that they apply to this contract. Supplements, amendments, or changes to these mandatory publications may be issued during the life of the contract. Advisory publications may be used for information and guidance but are not binding for compliance.

9.3 Publications: N/A

9.3.1 Mandatory:

Public Law 91-596 29 Dec 70 Occupational Safety and Health Administration

Public Law 104-191 (Aug 1996) Health Insurance Portability and Accountability Act of 1996

The Joint Commission (Jan 2026). Accreditation 360

Manual

AR 40-1 Composition, Mission, and Functions of the Army Medical Department

AR 40-3 Medical, Dental, and Veterinary Care, 21 July 2016 Edition

AR 40-400 Patient Administration

AR 40-68 Clinical Quality Management, 22 May 2009

AR 25-22 Army Privacy and Civil Liberties Program

AR 25-2 (Army Cybersecurity)

AR 380-49 (Industrial Security Program)

DoD Manual 5200.02 (Procedures for the DoD Personnel Security Program)

DoD Manual 6440.02 (Clinical Laboratory Improvement Program (CLIP) Procedures, August

2020 Change 1)

FM 1-02.1 (Operational Terms)

DA PAM 25-40 Army Publishing Directorate (APD)