PWS for W81XWH20Q0021 -- USAPHC.docx

PERFORMANCE WORK STATEMENT (PWS)

Title: American Industrial Hygiene Association- Laboratory Accreditation Program (AIHA-LAP) and Proficiency Testing Samples

Requiring Activity Name: U.S. Army Public Health Center (APHC)

1. INTRODUCTION

The American Industrial Hygiene Association Laboratory Accreditation Program (AIHA-LAP,LLC)) provides Industrial Hygiene accreditation for laboratory performing industrial hygiene analyses. This accreditation is vital to provide certification and verification of the quality of the Laboratory Sciences Directorate’s (LAB) industrial hygiene analyses in its mission to support the soldiers, civilians, and military family members in the Army community. The continuation of this accreditation and proficiency testing (PT) program is vital in sustaining the U.S. Army Public Health Center (APHC)’s ability to meet the analytical needs of our clients.

2. PURPOSE AND BACKGROUND

The mission of the APHC is to “Enhance Army readiness by identifying and assessing current and emerging health threats; developing and communicating public health solutions; and assuring the quality and effectiveness of the army’s public health enterprise.” As part of the APHC mission, the LAB performs sample analyses of Industrial Hygiene samples and Environmental Lead in Army operating environments and military bases to ensure the safety and security of all who work there. The APHC is seeking accreditation for Industrial Hygiene samples the LAB performs. The accreditation meet the requirements of DA PAM 40-11 Preventive Medicine, Federal and State Laws, and other DOD regulations. American Industrial Hygiene Accreditation-Laboratory Accreditation Program (AIHA-LAP) provides evaluation and accreditation of occupational health testing laboratories to ensure the quality of analytical data used for regulatory purposes meets the requirements of various programs, regulators and state agencies. Enrollment and analysis of PT samples provided by American Industrial Hygiene Association Proficiency Analytical Testing Programs, LLC (AIHA PAT programs) is a requirement to participate in this accreditation program.

3. SCOPE

The Contractor shall possess the following capabilities:

· Provide Environmental Lead Proficiency Testing samples for paint chips, wipes, and soil;

• Provide assessor(s) possessing technical knowledge and experienced in the parameters requiring accreditation.

4. PERIOD OF PERFORMANCE

The periods of performance for this contract are as follows:

5. WORK SCHEDULE AND LOCATION

5.1. Work Location

The Contractors shall work at their facility and at the APHC Laboratory for the onsite audit portion of the requirement.

6. PERFORMANCE REQUIREMENTS

6.1. Objectives

Objective 1– Accredit the APHC LAB for the parameters and methods requested by the APHC.

Objective 2 – Provide the various Industrial Hygiene (IH) and Environmental Lead Proficiency Testing samples to meet the AIHA-LAP accreditation requirements for the calendar year.

6.2. Specific Tasks / Requirements

Objective 1: Key Task 1 – Review the quality documentation from the APHC LAB in preparation for the onsite audits.

Objective 1: Key Task 2 – Provide qualified AIHA-LAP certified auditor(s) to perform the required onsite audits.

Objective 1: Key Task 3 – Assess the laboratories by Subject Matter Experts for the laboratory’s particular field of testing using appropriate comprehensive checklists.

Objective 1: Key Task 4 - Review documentation, observe performance of each test procedure on the scope, and interview laboratory personnel to determine compliance and deficiencies.

Objective 1: Key Task 5 – Provide a final out-brief at the onsite assessment to the APHC Lab.

Objective 1: Key Task 6- Forward a final detailed written report (Deliverable 1) to the quality manager and Contracting Officer’s Representative (COR) within 30 calendar days of audit completion.

Objective 1: Key Task 7 - Provide documentation of AIHA-LAP accreditation (to include certificate and scope) (Deliverable 2) to the APHC upon AIHA-LAP acceptance of any corrective actions from APHC following completion of the assessment.

Objective 2: Key Task 1 – Provide the following Proficiency Testing Samples based on the AIHA-PAT published Proficiency Testing schedule with any applicable instructions per set:

· 2 Rounds of Diffusive 3M Proficiency Testing samples

· 4 Rounds of Industrial Hygiene Metals Proficiency Testing samples

· 4 Rounds of Industrial Hygiene Organics Proficiency Testing samples

· 4 Rounds of Environmental Lead Dust Wipes Proficiency Testing samples

· 4 Rounds of Environmental Lead in Paint Proficiency Testing samples

· 4 Rounds of Environmental Lead in Soil Proficiency Testing samples

Objective 2: Key Task 2 – Provide APHC with the results and acceptable ranges (Deliverable 3) of each set of Proficiency Testing samples.

Objective 2: Key Task 3 – Ship Proficiency Testing samples to the following address to maintain integrity of the samples and preservation requirements:

6.3. Management Reports and Plans

Contract Manpower Reporting Application (CMRA) (Deliverable 4). This is a mandatory requirement IAW Army Federal Acquisition Regulation Supplement (AFARS) 5137.91, Accounting for Contract Services.

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: http://www.ecmra.mil.

Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning with 2013. Contractors may direct questions to the help desk at:

http://www.ecmra.mil/.

7. DELIVERABLES

The contractor shall complete and submit deliverables in accordance with the “Deliverables Table” below. Unless specified in the PWS within the description of the deliverable, all deliverables will be made to the COR electronically.

DELIVERABLES TABLE

7.1. Reports and Documents

Reports and documents delivered by the contractor in the performance of this contract shall be considered Technical Data. All documentation shall reflect the latest version of the work product or activity, unless specifically directed otherwise by the Government. All documentation shall be prepared in accordance with (IAW) standard industry practices, ensuring electronically produced documents which reflect logical flow of material, tables of contents indexes and page numbering. Where applicable, the contractor’s attention is called to the availability of commercial, industry, federal, and military guides, instructions, and standards for many of the topics addressed in this PWS and under this contract.

7.2. Inspection and Acceptance

The COR delegated oversight of specific technical, functional and oversight responsiblities is responsible for inspection and acceptance of all services, incoming shipments, documents, and services.

Certification by the Government of satisfactory services provided is contingent upon the Contractor performing in accordance with the performance standards contained in the Performance Work Statement and all terms and conditions of this order, including all modifications.

7.3. COR Information

TBD

8. PERFORMANCE REQUIREMENTS SUMMARY MATRIX

The Government intends to utilize a Quality Assurance Surveillance Plan (QASP) to monitor the quality of the Contractor’s performance in relation to performance objectives. The Government will finalize the QASP immediately following award, and the COR will provide a copy of the final QASP to the contractor. The QASP is a living document and may be updated by the Government as necessary.

The Government will use the following performance requirements to measure the performance of the contractor. The contractor shall meet the Performance Objective(s) and Acceptable Quality Level(s) within the “Performance Requirements Summary Matrix” (PRS Matrix).

PERFORMANCE REQUIREMENTS SUMMARY MATRIX

8. TRAVEL/TEMPORY DUTY (TDY)

The COR is the CONUS travel order approval authority as designated in writing by the KO. All CONUS travel requirements (including plans, agenda, itinerary, or dates) shall be pre-approved by the COR and is on a strictly cost reimbursable basis. The Contractor shall be authorized travel expenses consistent with the substantive provisions of the JTR and the limitation of funds specified in this contract. Costs for travel shall be billed in accordance with the regulatory implementation of Public Law 99-234 and FAR 31.205-46 Travel Costs, subject to local policy and procedures.

8.1. Travel Arrangements

Arrangements for and costs of all travel, transportation, meals, lodging, and incidentals are the responsibility of the Contractor. The Contractor shall remain current on applicable regulations, policies, and procedures that may impact processes for travel and modify their processes accordingly. No later than 30 calendar days prior to scheduled CONUS travel date, the Contractor will prepare the estimate in an official memorandum format. The estimate shall include airline ticket costs, car rental, per diem, registration fees and any other allowable costs associated with the travel request. All travel and transportation shall utilize commercial sources and carriers provided the method used for the appropriate geographical area that results in reasonable charges to the government. The Government will not pay for economy plus, business class or first-class travel. The COR will provide the Contractor a signed approval of Government Contractor Official Travel Letter of Identification before the Contractor is authorized to travel CONUS. Estimated travel is indicated below:

8.2. Travel Claim Procedures, Approval, and Reimbursement

Travel shall be reimbursed after the KO has determined fair and reasonable cost reimbursement IAW the JTR and FAR Part 31.205-46. The Contractor shall submit an estimate (Deliverable 5) for travel to COR no later than 30 calendar days prior to the first day of travel; in order for the Contractor to obtain economical travel arrangement and cost. The contractor shall provide a Trip Report (Deliverable 6) following each trip.

The COR will verify the travel receipts are valid and match the travel requirements identified in the PWS. The Contractor shall provide a trip report (Deliverable 6) to include costs associated with the travel to the COR within ten (10) calendar days after the completion of travel trip. All travel costs shall be billed within 30 days after travel is complete unless an approval for later billing is approved by COR or KO. All travel cost reimbursement requests must detail all authorized expenses associated with the travel and all receipts including ticket stubs (booked airline, hotel receipts, etc.) shall be provided to substantiate claims for costs of all expense items in excess of $75.00.

9. GOVERNMENT FURNISHED PROPERTY

N/A

10. Contract Management

10.1. Government Management

The Contracting Officer’s Representative (COR) for this contract will be appointed by the Contracting Officer (KO). The COR will serve as the primary point of contact for all activities and issues that occur under this contract. Only the KO has the authority to enact changes to this award.

10.2. Contractor Management

The contractor shall designate a single Program Manager (PM) to be the contractor’s authorized point of contact (POC) with the COR. The PM will be responsible for formulating and enforcing performance standards, assigning contractor schedules, reviewing performance quality, communicating policies, purposes, and goals to subordinates. This will include coordination with the KO and the COR to resolve any issues that may arise, trends relating to the contract, or proposed changes or modifications to the contract.

10.3. Contractor Organization

The contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the requirement. The contractor shall ensure that all contractor personnel are advised of their chain of command and who they should contact if they have questions.

10.4. Subcontract management

N/A

11. COMPLIANCE DOCUMENTS

11.1. General Compliance

11.1.1. Federal Law

The services provided under this contract must be conducted in accordance with all Federal law, Department of Defense (DOD), Department of the Army (DA) and Medical Command (MEDCOM) laws and command laws, regulations, policies, and procedures that govern the conduct of regulated research.

Federal regulations governing regulations for human subject’s protection are found in 45 CFR 46. The International Convention on Harmonization Guidelines for Good Clinical Practice is the standard governing the conduct of research trials. References for military regulations and policies governing regulated research may be found at https://mrmc.amedd.army.mil/rodorphrpo.asp.

11.1.2. DoD Compliance Documents

A complete list of Department of Defense compliance documents providing specifications, standards, or guidelines can be found at http://www.dtic.mil/whs/directives/corres/dir.html

A complete list of Department of Defense compliance documents providing specifications, standards, or guidelines can be found at http://www.dtic.mil/whs/directives/corres/dir.html

a) Army Regulation 340-21, Army Privacy Program. http://www.army.mil/usapa/epubs/340_Series_Collection_1.html

b) Army Regulation 25-2, Information Assurance.

c) Title 21, CFR Part 11 Electronic Records: Electronic Signature. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11

11.2. Medical and Laboratory Compliance

11.2.1. Army Regulation 340-21, Army Privacy Program

Compliance information regarding Army Privacy program may be found at: http://www.army.mil/usapa/epubs/340_Series_Collection_1.html

12. OTHER TERMS, CONDITIONS, AND PROVISIONS

12.1. Non-Personal Services

This PWS identifies services that are strictly non-personal in nature, as defined by Federal Acquisition Regulation (FAR) Part 37, Service Contracting. To ensure there is no appearance of any personal services, the Government shall neither supervise contractor personnel nor control the method by which the contractor performs the required tasks. Under no circumstances shall the Government assign tasks or prepare work schedules for individual contractor personnel. It shall be the responsibility of the contractor to manage its personnel and to guard against any actions that give the perception of personal services. If the contractor believes that any actions constitute, or are perceived to constitute personal services, it shall be the contractor's responsibility to notify the Contractor Officer (KO) immediately.

12.2. Severable / Non-Severable Services

This award identifies services that are severable in nature.

12.3. Inherently Governmental Functions

This requirement has been reviewed and contains no services that are inherently governmental functions.

12.4. Organizational Conflict of Interest

U.S. Army Public Health Center (APHC) has categorized all service procurements into one of the following three categories as defined below, for the purpose of identifying, avoiding, or mitigating Organizational Conflicts of Interest (OCI) in accordance with (IAW) Federal Acquisition Regulation (FAR) Subpart 9.5. These categories are defined as follows:

Category 1: Command Wide Internal Support: Services which, by their very nature, give the Contractor access to non-public procurement sensitive data about the contract requirements, other contractors’ proprietary information, or put the contractor in a position to influence the award decision on a contract in which they are participating. Services would be characterized as having access to Command Wide procurement sensitive information, or work that could likely have an influence over follow-on awards or contracts with subordinate directorates/Commands.

Category 2: Program Management Support: Services which assist APHC in planning and managing an organization’s activities and programs. These include, for example: requirements analysis, acquisition support, budget planning and management, business process reengineering, program planning and execution support, and independent technical management support. Services would be characterized as having access to only Directorate or Subordinate Command level procurement sensitive information or work that would have little influence on follow-on requirements or requirements of other directorates/Subordinate Commands.

Category 3: Product Support. Services or end items required to meet the mission requirements of the organization’s activities and programs. These include, for example: concept exploration and development, system design, system development and integration, COTS procurement and integration, internal development testing, deployment, installation, operations, and maintenance. Services can be characterized as having little or no access to procurement sensitive information other than the immediate requirement and little chances of follow-on work that can be influenced by the immediate requirement.

12.5. Invoices

The contractor shall submit invoices monthly to Wide Area Work Flow (WAWF) with sufficient documentation to provide certification of invoice.

The contractor is responsible for properly preparing and forwarding to the appropriate Government official, the invoice and receiving report for payment. The contractor shall attach back up information to receiving reports for direct labor and Other Direct Costs (ODCs). Direct labor backup information shall reflect the person’s name, job title and quantity of hours worked for each pay period at a minimum. Backup information for ODCs shall list all elements of costs, such as travel breakout backup, including itinerary, dates of travel, name of employees traveling plus per diem costs shall accompany the receiving report. Equipment purchases are not authorized under this contract. The Wide Area Workflow – Receipt and Acceptance application is the required method of submission.

Where applicable, contractor will include additional ODC invoice details as required per protocol for any volunteer payments in support of this PWS.

12.6. Dissemination of Information/Publishing

There shall be no dissemination or publication, except within and between the Contractor and any Sub Contractors or specified Integrated Product/Process Team (IPT) members who have a need to know, of information developed under this order or contained in the reports to be furnished pursuant to this order without prior written approval of the COR or the Contracting Officer.

12.7. Contractor Identification

The Contractor shall ensure that Contractor personnel identify themselves as Contractors when attending meetings, answering Government telephones, providing any type of written correspondence, or working in situations where their actions could be construed as official Government acts. Contractors may not use or allude to former or current military rank during the performance of this work.

12.8. Attendance at Meetings

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

12.9. Data Rights

All data received, processed, evaluated, loaded, and created as a result of this contract shall remain the sole property of the Government and shall be returned to the Government at the conclusion of the contract, unless the KO grants a specific exception.

12.10. Anti-Terrorism and Operational Security

12.10.1. AT Level I Training (Deliverable 7).

All contractor employees, including subcontractor employees, requiring access to Army installations, facilities, and controlled access areas shall complete AT Level I awareness training 7 days prior to start date of on-site audit...

The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee to the COR or to the contracting officer, if a COR is not assigned, within 30 calendar days after completion of training by all employees and subcontractor personnel. AT Level I awareness training is available at the following website: http://jko.jten.mil.

12.10.2. Access and general protection/security policy and procedures.

This standard language is for contractor employees with an area of performance within an Army-controlled installation, facility, or area. Contractor and all associated subcontractor employees shall provide all information required for background checks to meet installation access requirements to be accomplished by the installation Provost Marshal Office, Director of Emergency Services, or Security Office.

Contractor workforce must comply with all personal identity verification requirements (CFR clause 52.204-9, Personal Identity Verification of Contract Personnel) as directed by DoD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

12.10.3. For contractors that do not require CAC, but require access to a DoD facility or installation.

Contractor and all associated subcontractor employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (Army Directive 2014-05/AR 190-13); applicable installation, facility and area commander installation and facility access and local security policies and procedures (provided by Government representative); or, at OCONUS locations, in accordance with status-of-forces agreements and other theater regulations.

12.10.4 iWATCH Training. This standard language is for contractor employees with an area of performance within an Army-controlled installation, facility, or area.

The contractor and all associated subcontractors shall brief all employees on the local iWATCH program (training standards provided by the requiring activity ATO). This locally developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the COR. This training shall be completed within 30 calendar days of contract award and within 15 calendar days of new employees commencing performance, with the results reported to the COR NLT 30 calendar days after contract award.

12.11. Sexual Harassment / Assault Response and Prevention (SHARP) (Deliverable 8) The contractor shall comply with OTSG/MEDCOM Policy Memo 16-033, Policy for Reporting Incidents of Sexual Assault and Sexual Harassment under the Sexual Assault Prevention and Response Program (SHARP). The SHARP reporting requirements apply only to knowledge obtained by contractor personnel while performing services under this contract.

The contractor shall require all contractor personnel with knowledge of an incident of sexual assault or sexual harassment occurring on a Government facility, to include a Government leased facility, where the contractor is providing services under this contract, to report the incident to the contractor who shall immediately (within 24 hours) report the incident in writing to the Government's COR or Contracting Officer. All incidents shall be reported whether they involve contractor personnel or Government personnel, or other individuals.

12.12. Compliance with Relevant DoD, Service, and Institutional Policy Regulations.

The Contractor shall comply with HIPAA and all relevant DoD/USG regulations for collection, storage, and transfer of sensitive data and PHI. In addition, the Contractor will comply with all requirements for communication of findings and publication in the scientific peer reviewed literature (e.g. Public Affairs clearance and Operational Security clearance for dissemination).

12.13. Personally Identifiable Information (PII) and Protected Health Information (PHI) The contractor shall comply with the DHA Procedures, and Information (PGI) 224 – Protection of Privacy and Freedom of Information, revised 17 May 2015. The contractor may access PII in the course of task response to the requirements of this contract, as such the contractor shall comply with the document entitled “Personally Identifiable Information (PII), Protected Health Information (PHI) and Federal Information Requirements”.

The Contractor shall establish appropriate administrative, technical, and physical safeguards to protect any and all Government data. The Contractor shall also ensure the confidentiality, integrity, and availability of Government data in compliance with all applicable laws and regulations, including data breach reporting and response requirements, in accordance with DFAR Subpart 224.1 (Protection of Individual Privacy), which incorporates by reference DoDD 5400.11, “DoD Privacy Program,” May 8, 2007, and DoD 5400.11-R, “DoD Privacy Program,” May 14, 2007. The contractor shall also comply with federal laws relating to freedom of information and records management. The Contractor shall comply with all requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) (Pub. L. 104-191), as implemented by the HIPAA Privacy and Security Rules codified at 45 CFR Parts 160 and 164, and as further implemented within the Military Health System (MHS) by DoD 6025.18-R, "DoD Health Information Privacy Regulation," January 24, 2003, and DoD 8580.02-R, “DoD Health Information Security Regulation, July 12, 2007.

IT services that collect, maintain, use, or disseminate personally identifiable information must be managed in a manner that protects privacy, in accordance with section 552a of Title 5, U.S.C. (Reference (aa)), DoD 5400.11 (Reference (ab)) and DoD 5400.11-R (Reference (ac)). DoDI 5400.16 (Reference (ad)) established the guidance for development, review, and approval of Privacy Impact Assessments, in accordance with chapter 36 of Title 44, U.S.C. (Reference (ae)).

13. ATTACHMENTS

Attachment 1 – Acronyms List

ATTACHMENT 1 – ACRONYMS LIST