PWS - BeLPT.pdf

DHA PWS Template V13 November 16, 2021

Department of Defense Defense Health Agency

Performance Work Statement

Beryllium Lymphocyte Proliferation Test (BeLPT) Services

Naval Health Clinic Hawaii

Makalapa Laboratory

November 16, 2021

PART 1

1.0 GENERAL INFORMATION

1.1 This is a non-personal services contract to provide Beryllium Lymphocyte Proliferation Test (BeLPT) Services.

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 Beryllium Lymphocyte Proliferation Test (BeLPT) Services as defined in this Performance Work Statement (PWS) except for those items specified as government furnished property and services. The contractor shall perform to the standards in this PWS.

1.3 Background: Occupational Safety and Health Administration (OSHA) mandates the medical surveillance of workers exposed to Beryllium. Naval Health Clinic (NHC) Hawaii Occupational Health Department requires Beryllium Lymphocyte Proliferation Testing (BeLPT) for at-risk employees as part of this medical surveillance.

1.4 Objectives: The objective of this contract is to acquire Beryllium Lymphocyte Proliferation Test (BeLPT) services to support NHC Hawaii Makalapa Laboratory in fulfilling OSHA-mandated medical surveillance of workers exposed to Beryllium. These services must be accurate, timely, and compliant with all applicable regulations.

1.5 Scope: This PWS covers the performance of BeLPT testing services for blood samples submitted by NHC Hawaii Makalapa Laboratory to the contractor, including sample processing, testing, result interpretation, and reporting. The scope also includes ensuring compliance with all relevant shipping regulations and maintaining patient data confidentiality.

1.6 Period of Performance (PoP):

Base From: 02/01/2026 To: 01/31/2027 Option 1 From: 02/01/2027 To: 01/31/2028 Option 2 From: 02/01/2028 To: 01/31/2029 Option 3 From: 02/01/2029 To: 01/31/2030 Option 4 From: 02/01/2030 To: 01/31/2031

1.7 Administrative specifications

1.7.1 Place of performance:

Contractor Facility

1.7.2 Recognized Federal holidays:

New Year’s Day January 1st

November 16, 2021

MLK Memorial Day 3rd Monday in January President’s Day 3rd Monday in February Memorial Day Last Monday in May Juneteenth Day June 19th Independence Day July 4th Labor Day 1st Monday in September Columbus Day 2nd Monday in October Veteran’s Day November 11th Thanksgiving Day 4th Thursday in November Christmas Day December 25th

1.7.3 Hours of operation: The Contractor is responsible for conducting business Monday thru Friday except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. 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.

1.7.4 Emergency Services: On occasion, services may be required to support an activation or exercise of contingency plans outside the normal duty hours.

1.8 Quality

1.8.1 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. A comprehensive written QCP shall be submitted to the CO and COR within 30 days after contract award. 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.

1.8.2 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).

1.9 Key personnel (Contractor): The contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the CO. The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. The contract manager or alternate shall be available between 7:00 a.m. to 4:00 p.m, Monday thru Friday except Federal holidays or when the government facility is closed for administrative reasons.

1.10 Reporting

November 16, 2021

1.10.1 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.

1.10.2 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.

These meetings shall be at no additional cost to the government.

1.11 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.

November 16, 2021

PART 2

2.0 DEFINITIONS, ACRONYMS, AND APPLICABLE

PUBLICATIONS/INSTRUCTIONS

2.1 Definitions:

2.1.1 Beryllium Lymphocyte Proliferation Test (BeLPT): The testing of blood samples to determine beryllium sensitivity by measuring lymphocyte proliferation.

2.1.2 Client: Naval Health Clinic (NHC) Hawaii Makalapa Laboratory

2.1.3 Contracting Officer (KO): 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.

2.2 Applicable Publications, DHA Administrative Instructions (AI), etc.

2.2.1 OSHA Standards for Beryllium Exposure: https://www.osha.gov/beryllium

2.2.2 HIPAA Regulations: https://www.hhs.gov/hipaa/for-professionals/privacy/laws-regulations/index.html

2.2.3 IATA Shipping Regulations for Biological Specimens:

https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/2022-06/Transporting-Infectious- Substances-Safely.pdf

2.2.4 DHA-Procedural Instruction 8140.01, Acceptable Use of DHA IT:

https://www.health.mil/-/media/Files/MHS/Policy-Files/SIGNED--DHAPI-814001-Acceptable- Use-of-DHA-Information-Technology-IT.ashx https://www.osha.gov/beryllium https://www.hhs.gov/hipaa/for-professionals/privacy/laws-regulations/index.html https://www.hhs.gov/hipaa/for-professionals/privacy/laws-regulations/index.html https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/2022-06/Transporting-Infectious-Substances-Safely.pdf https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/2022-06/Transporting-Infectious-Substances-Safely.pdf https://www.health.mil/-/media/Files/MHS/Policy-Files/SIGNED--DHAPI-814001-Acceptable-Use-of-DHA-Information-Technology-IT.ashx https://www.health.mil/-/media/Files/MHS/Policy-Files/SIGNED--DHAPI-814001-Acceptable-Use-of-DHA-Information-Technology-IT.ashx

November 16, 2021

PART 3

3.0 CONTRACTOR FURNISHED ITEMS AND SERVICES

3.1 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: provide Beryllium Lymphocyte Proliferation Test (BeLPT) Services.

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

3.3 Secret Facility Clearance: N/A

3.4 Materials: The contractor shall furnish all materials, supplies, and equipment necessary to meet the requirements under this PWS, including but not limited to: blood collection tubes, reagents, shipping containers, and laboratory supplies.

3.5 Equipment: The contractor shall furnish all equipment necessary to meet the requirements under this PWS, including but not limited to: laboratory equipment for BeLPT testing, computers, and communication equipment.

3.6 Facilities: The contractor shall furnish all facilities, space, etc. necessary to meet the requirements under this PWS, including a CLIA-certified laboratory space suitable for performing BeLPT testing.

November 16, 2021

PART 4

4.0 SPECIFIC TASKS

4.1 BeLPT Testing and Analysis: The contractor shall perform BeLPT testing on blood samples submitted by NHCH Makalapa Laboratory, ensuring accurate and reliable results that meet established medical and laboratory standards.

4.1.1 Deliverables: NHC Hawaii will draw blood samples into sterile hepranized vacutainers.

Tubes will be labeled as “LPT-Beryllium” with the following information:

• Patient name

• Date of blood draw

NHC Hawaii will submit a requisition with the name of the patient, date of birth, sex, and blood collection date and time of each sample.

NHC Hawaii will ship the specimens via priority overnight courier to reach the contractor within 24-48 hours after the blood draw. NHC Hawaii is responsible for payment of the overnight courier expenses. NHC Hawaii will ensure that specimens comply with all Federal and IATA shipping regulations.

4.1.2 Sample Acceptance: The contractor shall accept blood samples Monday through Saturday, excluding Federal Holidays, and shall have a process for notifying NHCH of any sample rejections within 24 hours of receipt. The contractor may reject a specimen under the following conditions:

4.1.2.1 Leakage or breakage

4.1.2.2 Unclear labeling

4.1.2.3 Insufficient information about the specimen, no name on the requisition, or incomplete reporting information.

4.1.3 Result Reporting: The contractor shall provide accurate and interpretable BeLPT results to the Client's Occupational Health Department via fax (808-471-1437) within 14 calendar days of sample receipt. Results must include tabulation and interpretation of test data, adhering to established medical and laboratory standards.

4.2 Communication and Scheduling:

4.2.1 Sample Scheduling: The contractor shall maintain a system for scheduling sample submissions. NHC Hawaii will contact 800-550-6227 or fax 303-270-2175 with the anticipated number of samples and the date of shipment. Tests can be scheduled up to 30 days in advance of shipping. NHC Hawaii may also use the on-line scheduling calendar to schedule tests. NHC Hawaii will contact the contractor Beryllium Program Representative for information.

4.3 Quality Control and Assurance: The contractor shall implement and maintain a comprehensive Quality Control Plan (QCP) that ensures the accuracy, reliability, and timeliness

November 16, 2021 of BeLPT testing services. The QCP shall include, but not be limited to, procedures for sample handling, instrument calibration, data validation, and corrective action.

4.4 Data Security and Confidentiality: The contractor shall maintain a secure and confidential system for the storage and transmission of patient data, complying with HIPAA regulations and DHA security policies.

November 16, 2021

PART 5

5.0 INFORMATION TECHNOLOGY & SECURITY

5.1 All work under this contract is unclassified.

5.2 The TIER level and position sensitivity designation for positions under this contract is: TIER II: Non-critical sensitive position.

5.3 Personally Identifiable Information (PII)/Protected Health Information (PHI), Procurement, and Federal information requirements: User will need to include all PII/PHI, and Federal information requirements to include DoDI 5400.11, DoD Privacy and Civil Liberties Programs if applicable) (Refer to Clause Section, Attachments 1 and 2 of DHA Procedures, Guidance and Information 224.90, Personally Identifiable Information (PII), PHI), and Federal Information Requirement) (Adherence to DHA Administrative Instruction-110, Safeguarding Procurement Sensitive Information, is required.)

5.3.1. Data Sharing Agreements (DSAs): Contractors requiring access to PII, which includes PHI, or access to de-identified data, are subject to the DHA Privacy and Civil Liberties Office (DPCLO) (Privacy Office) Data Sharing Program. This program requires DHA to enter into DSAs with parties outside the MHS who use or create MHS data. A DHA contract may use the term Data Use Agreement (DUA) rather than DSA. DSAs assure that outside parties protect MHS data in accordance with the Privacy Act and the HIPAA Rules. To apply for a DSA, the contractor submits a Data Sharing Agreement Application (DSAA) to the DHA DPCLO. The contractor submits the DSAA even if a subcontractor will be the party accessing MHS data.

After review and approval of the DSAA, the Privacy Office provides a DSA to the contractor for execution.

5.3.2. Processing Procurement Sensitive Information: All individuals shall seek guidance from the KO regarding the coordination of documents, dissemination, and transmission of procurement sensitive information. Procurement sensitive information shall not be transmitted electronically unless encryption is utilized. Depending on a particular procurement, other restrictions may apply.