Exhibit A - PWS - Medical Laboratory Testing Service - 12-07-2021.docx

PERFORMANCE WORK STATEMENT (PWS)

FOR

Medical Laboratory Testing Services

1.0 General:

1.1 Scope: The contractor shall provide all personnel, equipment, tools, materials, supervision, and quality control necessary, except as specified in Paragraph 3.0 as Government Furnished, to perform Medical Laboratory Testing Services, as defined in this PWS.

1.1.1 Reserved

1.2 Background: Individual medical preparedness is vital for the Maine Army National Guard (MEARNG) to be a viable deployable force for Federal mission and State emergency responses. Laboratory testing is just one of the functions of individual medical readiness. Laboratory testing has become more frequent and larger in scope over the years, due to increase in deployments and local missions. The workload has now become a requirement for states to have done prior to sending soldiers to MOB platforms and for baseline and routine health and wellness assessments of our soldiers.

1.3 Period of Performance (PoP): The Period of Performance shall be one Base Year from 2 March 2022 to 1 March 2023 and two 12-month option years.

1.4 General Information:

1.4.1 Place and Performance of Services: The Government will perform the collection of all specimens at the government location. The contractor shall perform laboratory testing at the contractor laboratory site. The contractor shall be available to pick up samples within 24 hours of notification and provide services between hours of 0800 and 1700, except on recognized US holidays or when the Government facility/installation is closed due to local or national emergencies, administrative closings, or similar Government-directed facility/installation closings. The services would be Monday through Friday and pre-scheduled drill weekends of unit training assembly’s usually the first weekend of every month. The contractor shall at all times maintain an adequate work force for the uninterrupted performance of all tasks defined within this PWS when the Government facility/installation is not closed for the above reasons. When hiring personnel, the contractor shall keep in mind that the stability and continuity of the work force are essential.

Government sites are located at:

MEDCOM

194 Winthrop Street Camp Keyes Bldg. 7 Augusta, Me 04330

Augusta Amory 179 Western Avenue Augusta, Me 04330

Regional Training Institute (RTI) 289 Hildreth Street, North Bangor, Me 04401

Brunswick Readiness Center 11 Ordnance Road Brunswick, Me 04011

Northern Maine Readiness Center 6 Edgemont Drive Presque Isle, Me 04769

Army Aviation Flight Facility (AASF) 92 Hayes Street Bangor, Me 04401

1.4.1.1 Telework: Reserved

1.4.1.2 Unscheduled gate closures by the Security Police may occur at any time causing all personnel entering or exiting a closed installation to experience a delay. This cannot be predicted or prevented. Contractors are not compensated for unexpected closures or delays. Vehicles operated by contractor personnel are subject to search pursuant to applicable regulations. Any moving violation of any applicable motor vehicle regulation may result in the termination of the contractor employee’s installation driving privileges.

1.4.1.3 The contractor’s employees shall become familiar with and obey the regulations of the installation; including fire, traffic, safety and security regulations while on the installation. Contractor employees should only enter restricted areas when required to do so and only upon prior approval. All contractor employees shall carry proper identification with them at all times, and shall be subject to such checks as may be deemed necessary. The contractor shall ensure compliance with all regulations and orders of the installation, which may affect performance. The Government reserves the right to direct the removal of an employee from Government property or revoke access to Government systems for misconduct, security reasons, or any overt evidence of communicable disease. Removal of contractor employees for reasons stated above does not relieve the Contractor from responsibility for total performance of this contract.

1.4.2 Recognized Holidays: The following are recognized United States (US) holidays. The contractor shall note perform services on these days:

1.4.2.1 New Year’s Day: January 1st

1.4.2.2 Martin Luther King, Jr.’s Birthday

1.4.2.3 President’s Day

1.4.2.4 Memorial Day

1.4.2.5 Juneteenth National Independence Day: June 19th

1.4.2.6 Independence Day: July 4th

1.4.2.7 Labor Day

1.4.2.8 Columbus Day

1.4.2.9 Veteran’s Day: November 11th

1.4.2.10 Thanksgiving Day

1.4.2.11 Christmas Day: December 25th

1.4.3 Quality Control (QC): The contractor shall develop and maintain an effective QC Plan (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 QCP is the means by which it assures itself that its work complies with the requirements of the contract. As a minimum, the contractor shall develop QC procedures that address the areas identified in Technical Exhibit 1, Performance Requirements Summary (PRS). A final QCP shall be submitted to the Contracting Officer Representative (COR) NLT 10 days after contract award. After acceptance of the QCP, the contractor shall obtain the Contracting Officer’s (KO’s) acceptance in writing of any proposed changes to its QCP.

1.4.4 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 is primarily focused on what the Government will 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 acceptable quality level(s) or defect rate(s).

1.4.5 Installation Access and Security Requirements. The contractor shall comply with all applicable installation/facility access and local security policies and procedures, which may be obtained from the COR. The contractor and all associated subcontractor employees shall 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. The contractor shall ensure compliance with all personal identity verification requirements as directed by Department of Defense (DoD), Headquarters Department of Army (HQDA) and/or local policy (see PWS 6.0). Should the Force Protection Condition (FPCON) change, the Government may require changes in contractor security matters or processes.

1.4.5.1 Reserved:

1.4.5.2 For contractors that do not require a CAC, but require access to a DoD facility or installation: Contractor and all associated sub-contractors employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification (NCIC-III) and Terrorist Screening Database (TSDB) (Army Directive 2014-05), and applicable installation, facility and area commander installation/facility access, and local security policies and procedures (provided by a Government representative).

1.4.5.3 Awareness Training (AT) Level 1: All contractor employees, including subcontractor employees, requiring access to Army installations, facilities, and controlled access areas shall complete AT Level 1 training within 30 calendar days after contract start date and within 30 calendar days of new employees commencing performance. The contractor shall submit certificates of completion for each affected contractor and subcontractor employee to the COR within 15 calendar days after completion of training by each employee or subcontractor personnel. AT Level 1 awareness training is available at the following website: https://jko.jten.mil/courses/atl1/launch.html.

1.4.5.4 Reserved.

1.4.5.5 Communications Security/Information Technology (COMSEC/IT) Security. All communications with DoD organizations are subject to COMSEC review. All telephone communications networks are continually subject to intercept by unfriendly intelligence organizations. DoD has authorized the military departments to conduct COMSEC monitoring and recording of telephone calls originating from, or terminating at, DoD organizations. Therefore, the contractor is advised that any time contractor personnel place or receive a call they are subject to COMSEC procedures. The contractor shall ensure wide and frequent dissemination of the above information to all employees dealing with DoD information. The contractor shall abide by all Government regulations concerning the authorized use of the Government's computer network, including the restriction against using the network to recruit Government personnel or advertise job openings.

1.4.5.6 Reserved

1.4.5.7 Reserved

1.4.5.8 Reserved

1.4.5.9 Reserved.

1.4.5.10 Protection of Personally Identifiable Information (PII). The contractor shall protect all PII encountered in the performance of services in accordance with Defense Federal Acquisition Regulation Supplement (DFARS) 224.103 Personally Identifiable Information and Department of Defense Directive (DoDD) 5400.11, Department of Defense Privacy Program, and DoD 5400.11-R. If a PII breach results from the contractor’s violation of the aforementioned policies, the contractor shall bear all notification costs, call-center support costs, and credit monitoring service costs for all individuals whose PII has been compromised.

1.4.5.11 Reserved

1.4.5.12 Reserved

1.4.5.13 Reserved

1.4.5.14 Reserved

1.4.6 Physical Security. The contractor shall safeguard all Government property provided for contractor use. At the close of each work period, Government facilities, equipment and materials shall be secured.

1.4.6.1 Reserved

1.4.7 Special Qualifications: The contractor shall ensure all employees possess all required licenses and any other certifications to operate in a laboratory environment, during the performance of this contract. This does not include education or other qualifications for the position in which the contractor employee is performing, dress codes, or other information. (NOTE: The Government does not provide training to contractors. Contractors must ensure that any personnel performing under a contract are fully trained, licensed, certified, and otherwise qualified to provide services.)

1.4.8 Post Award Conference/Periodic Progress Meetings: The contractor agrees to attend any post award conference convened by the KO in accordance with FAR 42.5. The KO, COR and other Government personnel, as appropriate, may meet periodically with the contractor to review the contactor’s performance. At these meetings, the KO 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. The contractor shall resolve outstanding issues raised by the Government. Contractor attendance at these meetings shall be at no additional cost to the Government.

1.4.9 Contract Manager (CM): The contactor shall designate a CM who shall ensure performance under this contract. The name of this person, and an alternate who shall act for the contractor when the CM is absent, shall be designated in writing to the KO. The CM or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. The CM shall work through the COR to resolve issues, receive technical instructions, and ensure adequate performance of services. The CM shall ensure that contractor employees do not perform any services outside the scope of the contract without an official modification issued by the KO. The CM shall ensure contractor employees understand that services performed outside the scope of the contract are performed wholly at the expense of the contractor.

1.4.10 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 are required to identify themselves as such to avoid creating an impression that they are Government employees. The contractor shall ensure that all documents or reports produced by contractor personnel are suitably marked as contractor products or that contractor participation is appropriately disclosed. The contractor’s status as a “contractor” shall be predominantly displayed in all correspondence types (to include signature blocks on e-mail) and dealings with Government or non-Government entities. Contractor personnel shall wear identification badges distinguishing themselves as such. The badges shall have the company name, employee name and the word “contractor” displayed.

1.4.11. Combating Trafficking in Persons: The United States Government has adopted a zero tolerance policy regarding trafficking in persons. Contractors and contractor employees shall not engage in severe forms of trafficking in persons during the period of performance of the contract; procure commercial sex acts during the period of performance of the contract; or use forced labor in the performance of the contract. The Contractor shall notify its employees of the United States Government’s zero tolerance policy, the actions that will be taken against employees for violations of this policy. The contractor shall take appropriate action, up to and including termination, against employees or subcontractors that violate the US Government policy as described at FAR 22.17.

1.4.12 Contractor Travel: Travel Costs incurred by contractors are not reimbursable under the subject contract, and should be incorporated into FFP pricing along with any other direct and indirect costs.

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

1.4.14 Organizational Conflicts of Interest (OCI): The contractor and subcontractor personnel performing services 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 OCIs, as defined in FAR Subpart 9.5. The contractor shall notify the KO 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 KO to avoid or mitigate any such OCI. The contractor’s mitigation plan will be determined to be acceptable solely at the discretion of the KO. In the event the KO unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, the KO may impose 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.

1.4.15 Reserved

2.0 Definitions and Acronyms:

2.1 Definitions:

2.1.1 Contractor: 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.

2.1.2 Defective Service: A service output that does not meet the standard of performance associated with the PWS.

2.1.3 Deliverable: Anything that can be physically delivered and includes non-manufactured things such as meeting minutes or reports.

2.1.4 Key Personnel: Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of a contract by the PWS. When key personnel are used as an evaluation factor in best value procurement, an offer can be rejected if it does not have a firm commitment from the persons that are listed in the proposal.

2.1.5 Physical Security: Actions that prevent the loss or damage of Government property.

2.1.6 Quality Assurance: The Government procedures to verify that services being performed by the Contractor are performed according to acceptable standards.

2.1.7 Quality Assurance Surveillance Plan (QASP): An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

2.1.8 Quality Control: All necessary measures taken by the Contractor to ensure that the quality of an end product or service shall meet contract requirements.

2.1.9 Subcontractor: One that enters into a contract with a prime contractor. The Government does not have privity of contract with the subcontractor.

2.2 Acronyms:

3.0 Government Furnished Property, Material, Equipment and Services (GFP/M/E/S): The Government will provide the property, material, equipment, and/or services listed below solely for the purpose of performance under this contract:

3.1 Property None

3.2 Materials: None

3.3 Equipment: None

3.4 Services: None

3.5 Utilities: None

4.0 Contractor Furnished Property, Materials, and Equipment (CFP/M/E): MEARNG expect contractors to supple the government with required collection tubes, collection bio bags, and all associated supplies needed for blood draws. Also require locked collection boxes for outside building for off hour pick-ups.

4.1 General: Except for those items specifically stated to be Government-Furnished in Paragraph 3.0, the contractor shall furnish everything required to perform these services as indicated in Paragraph 1.1.

4.1.2 Personal Protective Equipment (PPE): Contractor shall furnish and assure healthcare workers are provided with the appropriate PPE such as, but, not limited to: gloves, protective eyewear, etc., where there is a potential for exposure to blood or other potentially infectious materials.

5.0 Requirements: The contractor shall:

5.1 All clinical laboratory services shall be performed by a laboratory licensed through the U.S. Department of Health and Human Services (DHHS) pursuant to the terms of the Clinical Laboratories Improvement Act of 1967 (42 U.S.C. 263a).

5.1.1 Contractor shall be licensed by the State of Maine to provide the specific services required with a minimum of three (3) years of clinical laboratory experience.

5.1.2 Contractor will provide instruction to Medical Readiness Unit on how to label the collection tubes, what tubes will be used for each specific individual test, and lastly how to fill out the contractors’ requisition (lab order) forms. This is all to ensure prompt and accurate lab testing of samples collected for processing.

5.1.3 Contractor will provide monthly invoices for services rendered through Procurement Integrated Enterprise Environment (PIEE), Wide Area Workflow (WAWF), no-later-than ten calendar days after the previous month end.

5.1.4 Analyze and result samples with standard of 99.5% tested with no more than 2% error.

5.1.5 Contractor will record the results and reports to Medical readiness unit within 48 hours of specimen pick up.

5.1.6 Bloodborne Pathogens Regulatory Compliance: All healthcare workers shall comply with the requirements of 29 CFR 1910.1030 Bloodborne Pathogens standard.

5.1.7 Equipment Regulatory Compliance: Instrumentation shall meet or exceed appropriate performance standards, and calibration accuracy in accordance with local, state, and federal regulation. Supporting documentation indicting equipment compliance shall be provided when requested.

5.2.1 Laboratory Service: Contractor shall retrieve specimen samples from designated location identified in paragraph 1.4.1 within 24 hours of notification from the government of request for lab service, conduct laboratory testing of specified samples and provide laboratory test service, conduct laboratory testing of specified samples and provide laboratory test results of the government within 48 hours of receipt of specified samples.

Service

5.2.40 . The contractor shall ensure all laboratory facilities used to perform this requirement of this contract meet the maintain all certifications(s), accreditation(s), license(s) ect. required when executing performance under this contract.

5.2.41 Contractor shall ensure licensed medical technicians perform the screening/testing elements.

5.2.42. Contractor shall ensure each healthcare worker complies with the requirements of 29 CFR 1910.1030 Blood Borne Pathogens Standard.

5.2.43 Infectious Waste Transportation and Disposal: Transportation and disposal of all infectious waste shall be in accordance with local, state, and federal regulation.

5.2.44. Designated Courier/Driver. The contractor shall provide the name fo designated couriers/drivers as prescribed in paragraph 1.4.5. The vehicle shall be utilized to transport the laboratory specimen with temperature-controlled coolers.

5.2.45 Test requiring refrigerated specimens shall be maintained the correct temputure during transporation and will arrive refrigerated at the temperature at the contractor facility.

5.2.46. Any specimens that have been broken, leaked or otherwise compromised during transit shall be reported to the COR immediately upon unpacking at the contractor’s site. The contractor shall be required to pick up new specimen(s) at no additional cost to the Government.

5.2.47. The Contractor shall ensure work meets quality and timeliness requirements specified in this contract, to include scheduling change(s) of technicinans, and courier services

6.0 Applicable Publications: Publications applicable to this PWS are listed below:

Publication (Chapter/Page)

Federal Acquisition Regulation

Defense Federal Acquisition Regulation Supplement

AFI 10-245 Antiterrorism

Index/#/?view=pubs&orgID=10141&catID=1&series=-1&modID=449&tabID=131

TECHNICAL EXHIBIT 1

Performance Requirements Summary (PRS)

This PRS includes performance objectives the Government will use to determine contractor performance and will compare contractor performance to the Acceptable Quality Level (AQL).

TECHNICAL EXHIBIT 2

Deliverables Schedule

Submission

COR

TECHNICAL EXHIBIT 3

Estimated Workload Data

This information is provided for historical background only. It is not a guarantee of workload quantities.

Workload is variable and based on the number of MEARNG soldiers who are attending medical readiness events or deployment soldier readiness processing events during the training year as well as approximately 30 soldiers every other Friday receiving routing medical readiness care for Chapter two physical and AGR periodic health assessments. These numbers will vary by event. Currently, the MEARNG has approximately 1876 soldiers.

The table below projects approximately: When and how many soldiers are to be seen during medical event periods. Not all these soldiers will need lab work it varies from year to year and age. This table does include the soldiers seen every other Friday at Camp Keyes Medical clinic - MEDCOM.

Regional Training Institute (RTI)

Regional Training Institute (RTI)

Brunswick Readiness Center

Augusta Armory

Augusta Armory

Camp Keyes, Augusta, ME

Ver. June 2021