Attachment II Performance Work Statement Newborn Screening Services for NMC Portsmouth.pdf

DHA PWS Template V13 November 16, 2021

Department of Defense Defense Health Agency

Performance Work Statement

Newborn Screening Services

Naval Medical Center Portsmouth (NMCP)

PART 1

1.0 GENERAL INFORMATION

1.1 This is a non-personal services contract to provide state mandated Newborn Screening Services (NBS) in support of Naval Medical Center Portsmouth, Virginia (NMCP).

1.2 Description of services/introduction: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform required Newborn Screening Services, as defined in this PWS except for those items specified as government furnished property and services. The contractor shall perform to the standards in this contract.

1.3 Background: On May 2021, Naval Medical Center Portsmouth awarded contract N6264521D5006 to the Virginia Department of General Services (VDGS) for Newborn Screening Services. The period of performance of the contract is 01 May 2021 through 30 April 2026. Naval Medical Center Portsmouth has contracted with College of American Pathologist (CAP) certified laboratories to provide high complexity testing not performed at NMCP. As part of the Department of Defense healthcare system, Naval Medical Center Portsmouth is required to comply with military, federal, and state public health regulations regarding newborn screening. Ensuring early detection of congenital and metabolic disorders is critical for readiness and the long-term health of military families.

1.4 Scope: The contractor shall provide newborn screening services for Naval Medical Center Portsmouth, VA. The Government reserves the right to add additional Military Treatment Facilities where Virginia State services may be required, as necessary, via bilateral modification. The contractor shall be responsible for delivering newborn screening services that adhere to all federal, state, and local regulations, laws, and ordinances. Furthermore, the contractor shall uphold all accreditations and certifications as listed in Section 5.5 of the Performance Work Statement. Services shall include the performance of laboratory analytical testing, as defined by the Laboratory's reference test manual, and timely reporting of screening results. The reporting of analytical test results and consultative services are required to assimilate the full scope of its laboratory operations to Naval Medical Center Portsmouth Laboratory Medicine Services.

1.5 Period of Performance (PoP): The contractor shall begin services per the Performance Work Statement on 01 May 2026. The Period of Performance has a Base Period of 01 May 2026 through 30 April 2027, including four optional periods/years.

Option Period 1: 01 May 2027 through 30 April 2028 Option Period 2: 01 May 2028 through 30 April 2029 Option Period 3: 01 May 2029 through 30 April 2030 Option Period 4: 01 May 2030 through 30 April 2031

1.6 Administrative specifications

1.6.1 Place of performance: The contractor shall perform newborn screening testing services through its designated reference laboratory.

Specimens collected by the Military Treatment Facility - Naval Medical Center Portsmouth shall be received for initial processing and forwarded to the contractor’s designated reference laboratory for newborn screening testing. The Government reserves the right to add additional Military Treatment Facilities where Virginia State services may be required, as necessary, via bilateral modification. All testing and result reporting shall be performed at the reference laboratory located at:

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Virginia Department of General Services Virginia Division of Consolidated Laboratory Services (DCLS) 600 North 5th Street Richmond, Virginia 23219

1.6.2 Recognized Federal holidays: The contractor is required to conduct business on Federally recognized holidays.

1.6.3 Hours of operation: The contractor is responsible for conducting business 24 hours a day, 7 days a week. The contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons.

1.7 Quality

1.7.1 Quality Control (QC): The contractor shall develop and maintain an effective QC program to ensure services are performed in accordance with this PWS. The contractor shall develop and implement procedures to identify, prevent, and ensure nonrecurrence of defective services. The contractor’s QC program is the means by which the work complies with stated requirements. After acceptance of the Quality Control Plan (QCP) the contractor shall receive the CO’s acceptance in writing of any proposed change to his QC system. See Part 7, Technical Exhibit 1 - CDRL A001.

1.7.2 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 provides a systematic method for the Government to evaluate performance and 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).

1.8 Contractor personnel

1.8.1 The Government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn is responsible to the Government.

1.9 Reporting

1.9.1 Contractor Manpower Reporting (CMR): RESERVED.

1.9.2 Non-Disclosure Agreement (NDA): All contractor personnel who will obtain access to proprietary, classified, or confidential information or any information release of which is protected or governed by law or regulation associated with DHA acquisitions shall be required to complete and sign a DHA contractor NDA (DHA Form 49) prior to beginning work on the subject contract. The contractor shall execute an NDA on behalf of the company and shall ensure that all staff assigned to, including all subcontractors and consultants, or other personnel performing on contract/Task order execute an NDA protecting the procurement sensitive information of the Government and the proprietary information of other contractors. The NDA shall be executed not later than first day of employment and to be renewed upon exercising a contract option period. Assignment of staff who has not executed this statement or failure to adhere to this statement shall constitute default on the part of the contractor. The contractor shall maintain originally signed NDAs of individual employees and provide copy to the COR.

1.9.3 Government’s COR: 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 CO 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 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 contract.

1.9.4 Post award conference/periodic progress meetings: The contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with FAR Subpart 42.5. The CO, COR, and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings the CO will apprise the contractor of how the government views the contractor's performance and the contractor will 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.

1.10 Contractor Identification

1.10.1 Contractor personnel performing services in a contractor capacity in a Government facility are required to possess and wear an identification badge that displays his or her name and the name of their company. All contractor personnel shall identify themselves as contractor support personnel in all forms of communication with all entities with whom DHA/Deputy Assistant Director for Acquisition (DAD- A)/Head of the Contracting Activity (HCA) has business dealings. The contractor shall: Answer all telephone calls and have a personalized voice message with an introductory statement that includes the fact that the person is contractor support personnel. Ensure all those with whom the person interacts in any face-to-face dealings while supporting the DAD-A understands that the person is contractor support personnel. Include a title block in all emails that states the fact that the person is contractor support personnel. Ensure all those with whom the person interacts in any face-to-face dealings while supporting DHA/DAD-A/HCA understands that the person is contractor support personnel.

1.10.2 Contractor personnel will be required to attend meetings or otherwise communicate with Government and/or other contract representatives to meet the requirements of this order. Contractor personnel shall make their contractor status known during introductions.

1.10.3 Contractor personnel, while performing in a contractor capacity, are prohibited from using their retired or reserve component military rank or title in any written or verbal communications associated with the contracts in which they provide services.

PART 2

2.0 DEFINITIONS, ACRONYMS, AND APPLICABLE PUBLICATIONS/INSTRUCTIONS

2.1 Definitions:

2.1.1 Category D: Information Technology (IT) and Telecommunications Services (called D-Services)

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2.1.2 Category R: Support (Professional/Administrative/Management) Services (called R-Services)

2.1.3 Contracting Officer (CO): A person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings.

2.1.4 Contracting Officer’s Representative (COR): An individual, including a contracting officer’s technical representative (COTR), designated and authorized in writing by the CO to perform specific technical or administrative functions. This individual does NOT have authority to change the terms and conditions of the contract.

2.1.5 Nonpersonal services contract: a contract under which the personnel rendering the services 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.

2.1.6 Quality Assurance Surveillance Plan (QASP): An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance. The Government may either prepare the QASP or require the offerors to submit a proposed quality assurance surveillance plan for the Government’s consideration in development of the Government’s plan.

2.1.7 Additional Definitions: None

2.2 Acronyms:

AIS Automated Information System APL Approved Products List APL AQL Acceptable Quality Level ARRT Acquisition Requirements Roadmap Tool ATO Authority to Operate B2B Business-2-Business CAC Common Access Card CAP Cloud Access Point CAP College of American Pathologists CCEVS Common Criteria Cybersecurity Evaluation and Validation Scheme CDI Covered Defense Information CE Computer Environment CDRL Contract Data Requirement List CIO Chief Information Officer CJCSM Chairman of the Joint Chiefs of Staff Manual CLIA Clinical Laboratory Improvement Amendments CMMC Cybersecurity Maturity Model Certification CMR Contractor Manpower Reporting CNSSI Committee on National Security Systems Instruction CO Contracting Officer(s) CONUS Continental United States (excludes Alaska and Hawaii) COR Contracting Officer Representative COTR Contracting Officer's Technical Representative CSP Cloud Service Provider CSSP Cyber Security Service Provider CUI Controlled Unclassified Information DAD-A Deputy Assistant Director for Acquisition

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DC3 DoD Cyber Crime Center DD Form 254 Department of Defense Contract Security Requirement List (if applicable) DB Design-Build DBB Design-Bid-Build DFARS Defense Federal Acquisition Regulation Supplement DHA Defense Health Agency DISA Defense Information System Agency DoD Department of Defense DoDD Department of Defense Directive DoDI Department of Defense Instruction DSAs Data Sharing Agreements DSAA Data Sharing Agreement Application DMZ Demilitarized Zone DoDM Department of Defense Manual DPCLO DHA Privacy and Civil Liberties Office DUA Data Use Agreement eMSM Enhanced Multi-Service Markets EULA End User License Agreement EVM Earned Value Management FAR Federal Acquisition Regulation FCI Federal contract information FE Facilities Enterprise FedRAMP Federal Risk Authorization and Management Program FISMA Federal Information Security Modernization Act FRCS Facility Related Control Systems FSO Facilities Security Officer HA Health Affairs HIPAA Health Insurance Portability and Accountability Act HCA Head of the Contracting Activity HIT Health Information Technology IGCE Independent Government Cost Estimate IA Information Assurance IO Initial Outfitting I/O In/Out Processing Portal IPv Internet Protocol Version IS Information System ISP Internet Service Provider IT Information Technology ISCM Information Security Continuous Monitoring IV&V Independent Verification & Validation MedCOI Medical Community of Interest MHS Military Health System MIL-STD Military Standard MTFs Military Treatment Facilities NCR National Capitol Region NDA Non-Disclosure Agreement NIAP National Information Assurance Partnership NIST National Institute of Standards and Technology OCONUS Outside Continental United States (includes Alaska and Hawaii) ODC Other Direct Costs OPM Office of Personal Management

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OSD Office of the Secretary of Defense P-ATO Personal Authorization to Operate P&R Personnel and Readiness PGI Procedures, Guidance and Information PDT Project Delivery Team PHI Protected Health Information PII Personally Identifiable Information PIT Platform Information Technology PK Public Key PKI Public Key Infrastructure POA&M Plan of Action and Milestones POC Point of Contact PMO Program Management Office PoP Period of Performance PP Personal Property PPSM Ports, Protocols, and Services Management PRS Performance Requirements Summary PSP Personnel Security Program PWS Performance Work Statement QA Quality Assurance QAP Quality Assurance Program QASP Quality Assurance Surveillance Plan QC Quality Control QCP Quality Control Plan RFP Request for Proposal RFQ Request for Quotation RMF Risk Management Framework SP Special Publication SPRS Supplier Performance Risk System SRM Sustainment, Restoration and Modernization SRG Security Requirements Guides STIG Security Technical Implementation Guides TOS Terms of Service US United States UFC Unified Facilities Criteria VPN Virtual Private Network XML Extensible Markup Language

PART 3

3.0 GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

The Requiring Activity Authority has assessed the need for Government Furnished Property, Equipment, and Services and determined:

3.1 Services: The Government:

☒ Will NOT provide Government Furnished Services in support of this contract/task order. As a result, this paragraph is Not Applicable.

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☐ WILL provide Government Furnished Services required in support of this contract/task orders. These Services are described below:

3.2 Facilities: The Government:

☒ Will NOT provide Facilities in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐ WILL provide Facilities in support of this contract/task orders. The Government provided Facilities are described below:

3.3 Utilities: The Government:

☒ Will NOT provide Utilities in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐ WILL provide Utilities in support of this contract/task orders. The Government provided Utilities are described below:

3.4 Equipment: The Government:

☒ Will NOT provide Equipment in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐ WILL provide Equipment in support of this contract/task orders. The Government provided Equipment is described below

3.5 Materials: The Government:

☒ Will NOT provide Materials in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐ IS providing Materials in support of this contract/task orders. The Government-provided Materials are described below:

PART 4

4.0 CONTRACTOR FURNISHED ITEMS AND SERVICES

4.1 Services: The Contractor:

☒ Will NOT provide Contractor Furnished Services in support of this contract/task order. As a result, this paragraph is Not Applicable.

☐ WILL provide Contractor Furnished Services required in support of this contract/task orders. These Services are described below:

4.2 General: The contractor shall furnish all supplies, equipment, facilities and services required to perform work listed under Section 5 of this PWS.

4.3 Materials: The contractor shall provide all testing cards, transport carriers/envelopes, courier services, and final reports.

4.4 Equipment: The contractor shall provide appropriate sample transport containers.

PART 5

5.0 SPECIFIC TASKS

5.1 Specimen Collection Material Supply and Specimen Transport

5.1.1 The contractor shall provide requisition forms, special instructions, current list of tests with reference ranges, list of specimen requirements, filter paper collection cards, shipping envelopes, and transmittal forms.

5.1.2 The MTF will provide the contractor with the filter paper card collected from all newborns by heel-stick between 24-48 hours of age.

5.1.3 The contractor is responsible for providing courier services to pick up samples at the NMCP laboratory and deliver them to VDGS for testing. Specimens shall be picked up once per day, seven (7) days a week (including holidays) by courier and transported to the contractor’s facility for analysis. The courier, Accurate Courier Express, Inc., will pick up the samples, which are then carried to a central hub.

The central hub is located at 550 Wood Lake Circle Suite C, Chesapeake, VA 23320. Once all samples have been collected, the courier service shall deliver the specimens to DCLS (Refer to 1.6.1), the same evening. The specimens shall be processed by the following day due to evening delivery.

5.2.1 The samples are to be delivered to DCLS within the 2-day (24-48 hours) transit goal established by

VDGS.

5.2.2 Samples are to be transported in the authorized transport envelope provided by VDGS to ensure the integrity of the specimens, avoiding excessive temperatures and moisture.

5.3 Screening Tests

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5.3.1 Sample Testing: The Reference Laboratory will comply with reporting test results within the specified time frame in accordance with the nature of the testing, following all regulatory requirements for reporting of patient results.

5.3.2 The contractor shall provide the MTF Newborn screening services to include laboratory testing for the detection of a core set of conditions and report results for additional disorders detected by this testing.

The conditions to be tested shall include those on the Recommended Uniform Screening Panel (which is hereby incorporated as reference and can also be found at https://www.hrsa.gov/advisory-committees/heritable-disorders/rusp), as recommended by the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children with the approval of United States Department of Health and Human Services and as approved by state law. Any conditions that are added to the Recommended Uniform Screening Panel throughout this contract period shall be added to the set of conditions screened under this contract as they are able to be incorporated and validated by the contractor. The contract may be modified if the cost of screening increases to include those conditions and or/if testing technologies change and/or improve.

5.4 Result Reporting: Test results shall be reported within the specified times established by the Reference Laboratories. Critical value test results shall be reported immediately by telephone. Hard copy results will be faxed, mailed or sent via a secure Internet report, in compliance with HIPPA guidelines.

Consult laboratories on test result by telephone as needed.

5.5 Special Qualifications: The contractor shall possess the following:

• Accredited by the College of American Pathologists (CAP).

• Clinical Laboratory Improvement Amendments

• Certified Laboratory with capability of performing all testing indicated by the VA Newborn Screening Program.

• Maintain all accreditations, licenses and certifications required for a Certified Clinical Diagnostic Laboratory to perform medical testing throughout the life of the contract. Documentation of all accreditations, licenses, and certification must be available upon request.

• Compliance with all Federal Regulations for providing Medical Laboratory Testing including PHI and HIPPA regulations.

• Commission on Laboratory Accreditation of the College of American Pathologists.

https://www.hrsa.gov/advisory-committees/heritable-disorders/rusp https://www.hrsa.gov/advisory-committees/heritable-disorders/rusp

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PART 6

6.0 INFORMATION TECHNOLOGY & SECURITY

6.1 All work under this contract is unclassified.

6.2 The TIER 1 or TIER 2 levels and position sensitivity designation for positions under this contract is:

Reserved.

6.3 Personally Identifiable Information (PII)/Protected Health Information (PHI), Procurement, and Federal information requirements: Reserved.

6.4 Training: Reserved.

6.5 Cybersecurity Requirements for Non-DoD IT or Covered Contractor IS: Reserved.

6.6 Risk Management Framework (RMF) for DoD IT: Reserved.

6.7. Facility Related Control Systems: Reserved.

6.8. System Communications: Reserved.

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PART 7, ATTACHMENT 1

PERFORMANCE REQUIREMENTS SUMMARY

The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

Performance Objective (The Service required—usually a shall statement from Part 5)

PWS Reference Acceptable Quality Level (AQL) (This is the maximum error rate. It could possibly be “Zero deviation from standard”)

Method of Surveillance

Performance Requirements Summary (PRS) # 1.

The contractor shall provide all materials for the collection and transport of samples

PWS part 5 section 5.1 99% Monitoring of orders and receipt of supplies.

PRS # 2

The contractor is responsible for providing courier services to pick up samples at NMCP laboratory and deliver them to VDGS for testing.

PWS part 5 section 5.2 99% Weekly spot checks of pending tests as well as monthly NBS report card.

PRS # 3

The Reference Laboratory will comply with reporting test results within the specified time frame in accordance with the nature of the testing, following all regulatory requirements for reporting of patient results.

PWS part 5 section 5.3 99% Random sampling

PRS # 4

Test results shall be reported within the specified times established by the Reference Laboratories. Critical value test results shall be reported immediately by telephone.

PWS part 5 section 5.4 99% Random sampling

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PART 7, ATTACHMENT 6

ESTIMATED WORKLOAD DATA

ITEM NAME ESTIMATED QUANTITY

1 Supplies 200 cards per month

2 Courier service 7 days / week

3 Testing 200 per month

4 Reports 200 per month

PART 7, TECHNICAL EXHIBIT 1

DELIVERABLES SCHEDULE

Deliverable Frequency Medium/Format Submit To Applicable to:

CDRL A001 –

Quality Control Plan

Within 30 days of task order award

Contractors’ discretion

CDRL A001 to CO All, See PWS 1.7.1