PWS_Medical Labs_2024 v1.pdf.docx

PERFORMANCE WORK STATEMENT (PWS) MA ARNG Blood and Urine Laboratories

1. GENERAL

1.1. SCOPE: The contractor shall provide all personnel, equipment, tools, facilities, materials, supervision, and quality control necessary, except as specified in Paragraph 3.0 as Government Furnished, to perform Blood and Urine Laboratories for MA ARNG personnel, as defined in this PWS.

1.1.1. Background: Massachusetts Army National Guard’s Medical Command (MA ARNG MEDCOM) requires vendor-supported laboratory diagnostics in order for Soldiers to meet requirements for duty. Performance shall be in accordance with the requirements outlined in Section 5 below.

1.2. Period of Performance (PoP): The Period of Performance shall be 30 SEP 2024 – 29 SEP 2025

1.3. General Information:

1.3.1. 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

1.3.2. The Contracting Officer may notify the Contractor of required modifications to the plan during the period of performance. The Contractor then shall coordinate suggested modifications and obtain acceptance of the plan by the Contracting Officer. Any modifications to the program during the period of performance shall be provided to the Contracting Officer for review no later than 10 working days prior to effective date of the change. The QCP shall be subject to the Governments review and approval. The Government may find the QCP "unacceptable” whenever the Contractors procedures do not accomplish quality control objective(s). The Contractor shall revise the QCP within 10 working days from receipt of notice that QCP is found "unacceptable."

1.3.3. Quality Assurance (QA): The Government will evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). Government personnel will record all surveillance observations. When an observation indicates defective performance, the COR will require the Contract Administrator to initial the observation. The initialing of the observation does not necessarily constitute concurrence with the observation, only the acknowledgment that they have been made aware of the defective performance. 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).

1.3.4. Recognized Holidays: The following are recognized United States (US) holidays. The contractor shall not perform services on these days:

New Year’s Day: January 1st Martin Luther King, Jr.’s Birthday: January 8th President’s Day: February 17th Memorial Day: May 26th Juneteenth National Independence Day: June 19th Independence Day: July 4th Labor Day: September 1st Columbus Day: October 13th Veteran’s Day: November 11th Thanksgiving Day: November 27th Christmas Day: December 25th

1.3.5. Place and Performance of Services: The contractor shall provide services at their facility. The MA ARNG will schedule each SMs treatment with the contactor. If the facility is closed due to local or national emergency, administrative closings, or similar Government-directed closings, the contact shall reschedule service at the earliest possible time.

1.3.6. 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.

1.3.7. Protection of Personally Identifiable Information (PII)/Health Information Portability and Accountability Act (HIPAA). 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. Additionally, the HIPAA Privacy Rule creates national standards to protect individuals’ medical records and other personal health information. All contract employees shall complete HIPAA certification course on a yearly basis. The contractor shall submit certificates of completion for each affected contractor and subcontractor employee, to the COR, or to the KO if a COR is not assigned, within 15 calendar days after completion of training. HIPAA training is available at http://www.health.mil/Training-Center/Joint-Knowledge- Online-JKO (https://jkodirect.jten.mil/Atlas2/page/login/Login.jsf)

1.3.8. Special Qualification: Contractors must ensure that any personnel performing under a contract are fully trained, licensed, certified and qualified to provide services.

1.3.9. Post Award Conference/Periodic Progress Meetings: The contractor agrees to attend any post award conference convened by the KO in accordance with FAR Subpart 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.

1.3.10. 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.

1.3.11. 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.

1.3.12. 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.

1.3.13. 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.

2. 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. Contracting Officer (KO): A person with 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.

2.1.3. Contracting Officer Representative (COR): An employee of the U.S. Government designated by the KO to monitor contractor performance. Such appointment will be in writing and will state the scope of authority and limitations. This individual has authority to provide technical direction to the Contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

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

2.1.5. 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.

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

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

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

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

2.1.10. 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:

DFARS Defense Federal Acquisition Regulation Supplement

Physical evaluation board

PII

Personally Identifiable Information

PIPO

Phase In/Phase Out

PHA

Periodic health assessment

POC

Point of Contact

7.

3. GOVERNMENT-FURNISHED PROPERTY

3.1. Government Furnished Property, Material, Equipment and Services (GFP/M/E/S): No GFP is to be used in the conduct of services on this contract.

4. Contractor Furnished Property, Materials, and Equipment (CFP/M/E):

4.1. General: Contractor shall provide all necessary supplies, equipment, and credentialed/privileged personnel needed to perform lab services.

4.2. Equipment. Medical providers shall meet all OSHA, HIPAA, ADA, radiological, and Privacy Act standards to ensure a safe and productive workspace for provision of contracted services.

4.3. contractor-provided facilities shall meet all OSHA, HIPAA and Privacy Act standards to ensure a safe and productive workspace for services under the Individual Readiness Requirements.

5. PERFORMANCE REQUIREMENTS 5.1. REQUIREMENTS:

5.1.1. Blood and urine specimens requiring laboratory work will be collected and stored by MA ARNG MEDCOM in accordance with all local, state, industry, and federal regulations.

5.1.2. Vendor must provide all necessary supplies and equipment for blood and urine specimen collection and transportation.

5.1.3. Vendor must have a physical location in MA and have drop-off locations with-in 30 miles of MEDCOM Building 1507, 59 Grenier St. Hanscom AFB, MA 01731.

5.1.4. Vendor must have clinical service centers that provide phlebotomy and lab services on behalf of MA ARNG MEDCOM throughout the New England and New York area.

5.1.5. Vendor shall pick-up specimens at agreed-upon date and location 7 days a week. Samples must be received at the vendor lab the same day they are picked up. Primary locations for pick up will either be MEDCOM Building 1507, 59 Grenier St. Hanscom AFB, MA 01731 (Sunday – Saturday) and/or Joint Base Cape Cod (Friday – Sunday). Additional pick-up locations may be added within MA as needed per mission requirements. The vendor agrees that no third parties will be used for pickup services as this disrupts chain of custody.

5.1.6. Vendor will provide a lockable drop box for afterhours lab pickup at each location.

5.1.7. Vendor currier must be able to pass a background check in order to gain access to Joint Base Cape Cod and HANSCOM AFB.

5.1.8. MA ARNG MEDCOM COR will coordinate with vendor for required laboratory tests and specimen pick up. Coordination can be via phone, fax, or vendor portals. The vendor portal should be the primary method of ordering and receiving labs. Paper order and fax should only be used as a backup.

5.1.9. Vendor must provide tests required in accordance with the schedule below. The MA ARNG MEDCOM requirement is not limited to the tests below. These are the most common labs needed and provided annually. MA ARNG MEDCOM ARNG will need full access to vendors lab catalog.

5.1.10. Laboratory results shall be communicated to MA ARNG MEDCOM personnel via vendor portal or faxed to MA ARNG Medical Detachment at 339-202-0119 attention to 1SG John Porreca.

5.2. Contractor shall be licensed on any services rendered and equipment operated during exams.

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

Title 29, Code of Federal Regulations, Part 1910:

Occupational Safety and Health Standards

regs/regulations/standardnumber/1910/1910TableofCo ntents

Title 29, Code of Federal Regulations, Part 1960:

Safety and Health Provisions for Federal Employees

Threshold Limit Values (TLV’s) and Biological Exposure Indices (BEI’s), American Conference of Governmental Industrial Hygienists (ACGIH), Cincinnati, Ohio.

Department of Defense 6055.05M, Occupational Medical Surveillance

Army Regulation 11-34, The Army Respiratory Protection Program

Department of the Army Pamphlet 40-506, The Army Vision Conservation and Readiness Program 15 July 2009

DoDM 5200.2 Regulation

5200.02 Procedures for the

DoD Personnel Security Program (PSP)

Army Directive 2014-05 Policy and Implementation Procedures for Common Access Card Credentialing and Installation Access for Uncleared Contractors

ir.aspx

AR 190-13

The Army Physical Security Program

x

Homeland Security Presidential Directive (HSPD)-12 Policy for a Common Identification Standard for Federal Employees and Contractors

DoDD 5400.11 Department of Defense Privacy Program

DoD 5400.11-R Department of Defense Privacy Program

DoDD 8140.01 Cyberspace Workforce Management

DoD 8570.01-M Information Assurance Workforce Improvement Program 12/19/2005 (Change 4:

11/10/2015) Mandatory http://www.dtic.mil/whs/directives/corres/pub1.html

AR 25-2

Information Assurance

AR 40-35 Dental Readiness And Community Oral Health Protection

6.1 Applicable Forms: Forms applicable to the PWS are listed below:

DD 1172-2

Application for Identification Card/DEERS Enrollment

x.htm

I-9 Employment Eligibility Verification

/sites/default/files/file s/form/i- 9.pdf

DD 441

Department of Defense Security Agreement

DD 250

Material Inspection and Receiving Report

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).

Quality Levels

(AQL)

Surveillance Method / By Whom

TECHNICAL EXHIBIT 2

Deliverables Schedule

PWS Reference /Deliverable Title

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