PWS_Laboratory Services.pdf

Ver. June 2021

PERFORMANCE WORK STATEMENT (PWS)

FOR

Medical Laboratory Testing and Analysis Services

1.0 General: The Medical Laboratory Testing and Analysis contract provides services to the New Hampshire Army National Guard's (NHARNG) Office of the State Surgeon and Medical Readiness Detachment to support medical readiness requirements prescribed in Army Regulation (AR) 40-66 and AR 40-501.

1.1 Scope: The contractor shall provide all personnel, equipment, tools, materials, supervision, and quality control necessary, except as specified in Paragraph 3.1 as Government Furnished, to provide Medical Laboratory Testing and Analysis Services, as defined in this PWS.

1.2 Background: The New Hampshire Army National Guard, Office of the State Surgeon and Medical Readiness Detachment, Concord, NH has a need for Medical Laboratory Testing and Analysis Services. These services will be acquired by placing task orders against a BPA.

1.3 The period of performance for this contractor shall be 01 August 2022 to 31 July 2023.

Base: 1 August 2022 to 31 July 2023 Option Year 1: 1 August 2023 to 31 July 2024 Option Year 2: 1 August 2024 to 31 July 2025 Option Year 3: 1 August 2025 to 31 July 2026 Option Year 4: 1 August 2026 to 31 July 2027

1.4 General Information:

1.4.1 Place and Performance of Services: The contractor shall provide services between the hours of 0730-1630 on Sunday through Saturday, 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 contractor will pick-up patient samples at Building M, 1 Minuteman Way, Concord, NH 03301.

1.4.2 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.

1.4.3 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.

1.4.5 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.

1.4.6 Recognized Holidays: The following are recognized United States (US) holidays.

The contractor shall not 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

1.5.1 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.

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

1.5.3 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.

1.5.4 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.

1.5.5 iWATCH Training: The contractor and all associated subcontractors with an area of performance within an Army-controlled installation, facilities or area shall brief all employees on the local iWATCH program (training standards provided by the requiring activity Antiterrorism Officer (ATO)). This local developed training shall be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the COR or the KO. This training shall be completed within 30 calendar days of contract award and within 30 calendar days of new employees commencing performance. The contractor shall report completion for each contractor employee and subcontractor employee to the COR within 15 calendar days after completion of training.

1.5.6 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.

1.5.7 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.

1.5.8 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.

1.5.9 The contactor shall prohibit the use of the Government issued keys/key cards by any persons other than the contractor’s employees. The contractor shall prohibit the opening of locked areas by contractor employees to permit entrance of persons other than contactor employees engaged in the performance of services in those areas, or personnel authorized entrance by the KO.

1.5.10 Lock Combinations: The contractor shall establish and implement methods of ensuring that no lock combinations are revealed to unauthorized persons. The contractor shall ensure that lock combinations are changed when personnel having access to the combinations no longer have a need to know such combinations.

1.5.11 Special Qualifications:

1.5.12 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.

1.5.13 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.

1.5.14 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.

1.5.15 The contractor shall retrieve all identification media (including vehicle passes) from its employees who depart employment for any reason. The contractor shall return all identification media (i.e., badges and vehicles passes) to the KO within 14 days of an employee’s departure.

1.5.16 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.

1.5.17 RESERVED

1.5.18 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.

2.0 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:

AEI Army Enterprise Infostructure AR Army Regulation AT/OPSEC Antiterrorism/Operational Security BI Background Investigation CM Contract Manager

COR Contracting Officer Representative DA Department of the Army DD254 Department of Defense Contract Security Classification Specification DFARS Defense Federal Acquisition Regulation Supplement DoD Department of Defense DSCA Defense Counterintelligence and Security Agency FAR Federal Acquisition Regulation GFP/M/E/S Government Furnished Property/Material/Equipment/Services HQDA Headquarters, Department of the Army HSPD Homeland Security Presidential Directive IA Information Assurance IS Information System(s) KO Contracting Officer NGB National Guard Bureau OCI Organizational Conflict of Interest PII Personally Identifiable Information PIPO Phase In/Phase Out POC Point of Contact PRS Performance Requirements Summary PWS Performance Work Statement QA Quality Assurance QASP Quality Assurance Surveillance Plan QC Quality Control QCP Quality Control Program SCR Service Contract Reporting SSN Social Security Number TE Technical Exhibit USD(I) Under Secretary of Defense for Intelligence

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: The Government will furnish the necessary workspace for the contractor to perform services outlined in this PWS to include desk space, telephones, computers and other items necessary to maintain an office environment.

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):

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.

5.0 Requirements:

5.1 Laboratory Service Regulatory Compliance: All clinical laboratory services shall be performed by a laboratory licensed through the U.S. Department of Health and Human Services (DHHS), Health Care Financing Administration pursuant to the terms of the Clinical Laboratories Improvement Act of 1967 (42 U.S.C. 263a) and the College of American Pathologies. Laboratory services shall be performed by personnel certified under the American Society of Clinical Pathology.

5.2 Hazardous Waste Regulatory Compliance: All infectious waste shall be disposed of in accordance with local, state, and federal regulation and disposed of by the contractor

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

5.4 Laboratory services: The contractor shall provide necessary supplies (tubes, caps and bio bags) and conduct and perform services being requested in this PWS for the following types of testing analysis:

Basic Metabolic Panel (8) Blood Type CBC With Differential/Platelet CBC/Diff Ambiguous Default CBC-Complete Blood Count (HGB/HCT, WBC, Platelet count) Chlamydia (Urinalysis) Complete Cholesterol (Total cholesterol, LDL,HDL, and Triglycerides) Creatine Kinase,Total Drug and Alcohol Test Fasting blood glucose and A1C Glucose Glucose-6-phosphate dehydrogenase (G6PD) Gonorrhea (Urinalysis) HCV Antibody RFX to Quant PCR Hematocrit Hemoglobin HEP B Surface Antibody HEP B Surface Antigen Hepatic Function Panel (7)

Hepatitis C (HCV) Hgb Frac. Profile Hgb Solubility Hgb+Hct LDL Cholesterol (Direct) Lipid (LP) Panel Lipid Panel w/ Chol/HDL Ratio Lipid Panel w/Glucose

LP+1AC+PSA

LP+Glu+PSA+UA/M+Hct LP+Glu+PSA+UA/M+Hct LP+Glu+PSA+UA/M+Hgb PA+Hct LP+Glu+PSA+UA/M+Sickle+Hct+...

LP+Glu+RPR+UA+Sickle+CBC/Plt LP+Glu+UA/M+Hct LP+Glu+UA/M+Hgb PA+Hct LP+Glu+UA/M+Sickle+Hct+G6PD...

LP+Glu+UA+Sickle+Hct LP+UA/M+Hct LP+UA/M+Sickle+Hct Measles/Mumps/Rubella Immunity Occult Blood, Fecal, IA Platelet Count Pregnancy Testing (Urinalysis) Price Per Pick Up Trip (unlimited samples) Prostate Specific Antigen Test (PSA) PSA, Serum Rfx ProstaSURE(TM) RPR (Rapid Plasma Reagin) Sickle Cell Testing Occult Blood, Fecal, IA Thyroid-Stimulating Hormone (TSH) Thyroxine (T4) Free, Direct, S Tuberculin Purified Protein Derivative (PPD) Uric Acid Urinalysis, Complete Urine Culture, Routine Urine specific gravity and urine Microscopic Other tests, as needed

5.4.2 The contractor shall be able to pick up test labs on Sunday through Saturday. The contractor shall pick up patient samples within 8 hours of notification. Samples will be picked up at the Medical Readiness Detachment (Bldg M) contractor provided drop box.

5.4.3 The contractor shall be able to return all test results no later than five (5) days after pickup. Results shall be made available to government POCs through access to web-based portal.

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

Publication

(Chapter/Page) Date of

Publication Mandatory or

Advisory Website

Federal Acquisition Regulation https://www.acquisition.gov/?q=browsefar Defense Federal Acquisition Regulation

Supplement http://www.acq.osd.mil/dpap/dars/dfarspgi/current/index.html or https://www.acquisition.gov/dfars Joint Travel Regulation (JTR) https://www.defensetravel.dod.mil/site/travelreg.cfm

DoDM 1000.13-M-V1 DoD Identification (ID) Cards (Enclosure 2, paragraph 3.b)

01/23/2014 (Change 1:

07/28/2020) http://www.esd.whs.mil/Directives/issuances/dodm

Federal Information Processing Standards (FIPS) Publication 201-2

Personal Identity Verification (PIV) of Federal Employees and Contractors

(paragraph 9)

August 2013 http://nvlpubs.nist.gov/nistpubs/FIPS/NIST.FIPS.201-2.pdf

DoDM 5200.2 Procedures for the DoD Personnel Security Program (PSP)

04/03/2017 https://www.esd.whs.mil/Directives/issuances/dodm/

DoDI 5200.46 DoD Investigative and Adjudicative Guidance for Issuing the Common Access Card (CAC)

09/09/14 (Change 1:

05/04/2018) https://www.esd.whs.mil/Directives/issuances/dodi/

Homeland Security Presidential Directive

(HSPD)-12

Policy for a Common Identification Standard for Federal Employees and Contractors

08/27/2004 https://www.dhs.gov/homeland-security-presidential-directive-12

DoDI 5400.11 Department of Defense Privacy and Civil

Liberties Programs

01/29/2019 https://www.esd.whs.mil/Directives/issuances/dodi/

DoD 5400.11-R Department of Defense Privacy Program

05/14/2007 https://www.esd.whs.mil/Directives/issuances/dodm/

DoDD 8140.01 Cyberspace Workforce Management

10/05/2020 https://www.esd.whs.mil/Directives/issuances/dodd/

DoD 8570.01-M Information Assurance Workforce Improvement

Program

12/19/2005 (Change 4:

11/10/2015) https://www.esd.whs.mil/Directives/issuances/dodm/

DoD 5220.22-M National Industrial Security Program Operating

Manual (NISPOM)

02/28/2006 (Change 2:

05/18/2016) https://www.esd.whs.mil/Directives/issuances/dodm/

DODI 6025.19 Individual Readiness https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/do di/602519p.pdf

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

Installation Access for Uncleared Contractors

03/07/2014 https://armypubs.army.mil/ProductMaps/PubForm/ArmyDir.aspx

AR 25-2

Information Assurance

04/04/2019 http://armypubs.army.mil/ProductMaps/PubForm/AR.aspx

AR 40-68 Clinical Quality Management https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/r40_68.pdf AR 40-501 Standards of Medical Fitness https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/ARN8673_

AR40_501_FINAL_WEB.pdf

AR 530-1

Operations Security 09/26/2014 http://armypubs.army.mil/ProductMaps/PubForm/AR.aspx

AR 525-13

Antiterrorism

12/09/2019 http://armypubs.army.mil/ProductMaps/PubForm/AR.aspx

AR 381-12

Threat Awareness and Reporting Program

(TARP)

(Section II, ¶ 2-4.b)

06/01/2016 http://armypubs.army.mil/ProductMaps/PubForm/AR.aspx

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).

Performance Objective

Performance Standard Acceptable Quality Levels (AQL)

Surveillance Method / By Whom

5.4.2 Timely Pickups &

Drop-off Times & Location

Compliance

Contractor shall be available for pickups/drop offs at designated hours, and pick up samples NLT 8 hours after placement of pickup call

No more than one instance monthly of late pickup or unavailability of dropoff

Periodic Inspection / COR

5.4.3 Results Delivery

Lab tests results shall be returned electronically to the Gov’t POCs NLT 5 days from pickup date.

No more than one instance monthly of late results delivery

Periodic Inspection / COR

TECHNICAL EXHIBIT 2

Deliverables Schedule

PWS Reference / Deliverable Title

Frequency Number of Copies

Medium/Format Submit To

1.5.1 Final QCP Within 10 days of contract

award

1 Electronic Submission

COR

1.5.4 AT Level 1

Awareness Training

Certificates

Provide within 15 calendar days after employee completes training.

1 Electronic Submission

COR

1.5.14 Identification

Media

Return within 14 days of employee’s departure from contract performance.

Original(s) Hard Copy COR

5.4.3 Contractor

report on data entry

No later than the 5th of each month.

1 Electronic Submission

COR