A01_PWS_10Jan.pdf

PERFORMANCE WORK STATEMENT (PWS)

Stable Isotope Compounding Services

USARIEM

SECTION 1 PURPOSE

1.1. Introduction: The Military Performance Division of the US Army Research Institute of Environmental Medicine (USARIEM) conducts research aimed at physical performance optimization, injury reduction/bone health, military biomechanics, cognitive/neurological performance, injury epidemiology, and deployment health and protection. The below services requirement supports research in the area of injury reduction/bone health.

1.2. Mission: Located in Natick, Massachusetts, USARIEM is an internationally recognized center of excellence for Warfighter performance science and its useful applications. USARIEM’s mission is to protect, sustain, and maximize the health and performance of military personnel through basic and applied research. Musculoskeletal injuries are one of the most prevalent and costly injuries in service members.

1.3. Background: USARIEM is part of the U.S. Army Medical Research and Materiel Command (USAMRMC). USARIEM is dedicated to Warfighter health and performance research with the focus on environmental medicine, physiology, physical and cognitive performance, and nutrition.

1.4. Scope: In order to better understand the effects of exercise and nutrition on skeletal and mineral metabolism, USARIEM has the requirement for a services contract for Stable Isotope Compounding Services.

1.5. Objective: The objective of this service contract is to have a licensed and accredited pharmacy compound sterile isotopes (provided by USARIEM) to be used in support of in vivo research protocols on the effects of nutrition and/or exercise on musculoskeletal and mineral metabolism. These isotopes are to be dispensed to USARIEM staff in individual dose vials which are certified as sterile, and fungal and endotoxin free, while meeting USARIEM determined potency requirements.

SECTION 2 GENERAL REQUIREMENT

2.1. Performance

2.1.1. Place of Performance

The contractor will perform all required tasks at the Contractor’s facility

2.1.2. Period of Performance. This contract is for one (1) twelve (12) months Base Period and four (4) twelve (12) months Option Periods. The periods of performance for this contract are as follows:

Base Year 2 March 2018 – 1 March 2019 Option Year 1 2 March 2019 – 1 March 2020 Option Year 2 2 March 2020 – 1 March 2021 Option Year 3 2 March 2021 – 1 March 2022 Option Year 4 2 March 2022 – 1 March 2023

2.2 Type of Services

2.2.1 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.

2.2.2 Severable / Non-Severable Services

This award identifies services that are severable in nature.

2.2.3 Inherently Governmental Functions

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

2.2.4 Acquisition Functions Closely Associated with Inherently Governmental Functions Not Applicable for this requirement.

2.3. Contract Management

2.3.1. 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.

2.4. Reports

2.4.1. 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.

2.4.2. Certificate of analysis for sterility, fungal and endotoxin testing for each compounded lot (Deliverable 5). The contractor shall provide documentation with detail of testing results for applicable contract line item number (CLIN). The reports are due prior to dispensing each lot, but no later than 21 days after compounding the lot.

2.4.3. Contract Manpower Reporting (Deliverable 1). 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 USARIEM 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/.

Register under the "All Other Defense Components" module. The US Army Research Institute of Environmental Medicine (USARIEM) Unit Identification Code (UIC) is W03WAA. The Federal Supply Code (FSC) is AN11.

2.4.4 Contractor Performance Assessment Reporting System (CPARS).

Not Applicable for this requirement.

2.4.5 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 http://www.ecmra.mil/ http://www.ecmra.mil/

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. All ODCs exceeding $3,000 requires that the contractor conduct appropriate competition and obtain approval from the COR prior to purchase.

Equipment purchases are not authorized under this contract. The Wide Area Workflow – Receipt and Acceptance application is the required method of submission.

SECTION 3 PERFORMANCE REQUIREMENTS

3.1. The contractor shall provide all necessary personnel required to perform services in support of USARIEM study requirements as listed above. The contractor shall provide Stable Isotope Compounding Support Services. The following section specifies the Performance Objectives and Performance Elements for the contract.

3.2.1 Specific Requirements:

Services include compounding of sterile stable isotope solutions to be administered to volunteers intravenously (IV) by USARIEM personnel.

3.2.2 The contractor shall accomplish sterile isotope compounding of approximately 40 doses per year prepared in two separate lots of 20 doses (vials) with a beyond use / expiration date of 180 days from the day of compounding. The exact number of lots will depend on volunteer enrollment and may therefore increase or decrease.

3.2.3 The contractor shall demonstrate adherence to all guidelines and regulations governing the preparation for sterile IV solutions for use in human research volunteers.

They must provide proof of sterility (USP <71>), fungal specific sterility, and endotoxin (USP<85>) testing of the isotope solutions for each lot prior to dispensing.

3.3.4 All compounding must be done in compliance with USP <795> and USP <797> standards, as well as all state and Federal requirements as applicable. All aseptic compounding must occur in an ISO 5 primary engineering control (PEC) room located inside of an ISO 7 Buffer Room. The sterile lab, must be maintained, certified and validated in compliance with USP <797> standards.

3.3.5 The pharmacy must demonstrate accreditation by the Pharmacy Compounding Accreditation Board (PCAB) and hold a state Board of Pharmacy license in Massachusetts. The pharmacy must also be located within driving distance to Natick, MA (</= 50 miles) to allow USARIEM personnel to pick up isotope solutions at the pharmacy.

3.3.6 USARIEM will provide the isotope, isotope certificate of analysis, and specific instructions for compounding to the contractor.

3.3.7. Compound and aliquot sterile stable calcium isotopes, provided by USARIEM, into 2 solution lots per year of at least 10 doses per lot, consistent with the USARIEM provided specifications and concentration and volume ranges, with expiration dates of 180 days from date of compounding. (Deliverable 2)

3.3.7.1 Ship a 250 microliter sample of each manufactured lot to an analytical laboratory of USARIEMs choice for potency analysis. (Deliverable 3)

3.3.7.2 Each lot must meet the potency tolerances (+/- 5% for calcium isotope concentrations) as described within each task order. (Deliverable 4)

3.3.7.3 Each lot must meet or exceed, and provide documentation and/or certification for the following USP standards for sterile injectables (Deliverable 5):

3.3.7.3.1 Sterility testing.

3.3.7.3.2 Fungal testing.

3.3.7.3.3 Endotoxin testing.

OPTION 1: one additional lot OPTION 2: one additional lot

3.3.8. Dispense single doses, approximately 32 per year, to USARIEM research study staff in sterile rubber stoppered vials with volumes consistent with USARIEM provided specifications.

OPTION 1: at least 10 additional doses OPTION 2: at least 10 additional doses

3.4. Performance Requirement 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

# PWS Ref. Performance Objective Acceptable Quality Level Performance Measurement Frequency

1. Contractor Manpow er Reporting

Submitted annually. 100% Complete 100% inspection Annual

2. PWS 3.3.7 Compound and aliquot sterile stable calcium isotopes, provided by USARIEM, into 2 solution lots of at least 10 doses per lot, consistent w ith the USARIEM provided specif ications and concentration and volume ranges, w ith expiration dates of 180 days from date of compounding

100% complete Report, each lot End of contract

3. PWS 3.3.7.1 Ship one 250 microliter sample from each compounding lot for potency testing to facility determined by

USARIEM

100% complete Report, each lot Upon lot competition

4. PWS 3.3.7.2 Each lot must meet the potency tolerances (+/- 5% for calcium isotope concentrations) as described w ithin each task order.

Concentrations +/- 5% of the specif ications as measured by USARIEM chosen laboratory

Report, each lot Upon receipt

5. PWS 3.3.7.3 Each lot must meet and provide documentation and/or certif ication for the follow ing USP standards for sterile injectables

100% passing 100% inspection, each batch

Prior to lot acceptance

6. PWS

3.3.7.3.1

Product meets United States Pharmacope (USP) <71> requirements for sterility testing

100% passing sterility tests Report, each batch

Prior to lot acceptance

7. PWS

3.3.7.3.2

Product meets United States Pharmacope (USP) requirements for fungal sterility testing

100% passing fungal sterility tests

Report, each batch

Prior to lot acceptance

8. PWS

3.3.7.3.3

Product meet United States Pharmacope (USP) <85> requirements for endotoxin testing

100% passing endotoxin tests Report, each batch

Prior to lot acceptance

9. PWS 3.3.8 Dispense single doses, approximately 32 per year, to USARIEM research study staff in sterile rubber stoppered vials w ith volumes consistent with USARIEM provided specif ications.

100% complete 100% inspection End of contract

Types of Surveillance Methods of Surveillance Customer Complaints Management Information Systems Random Sampling Observation of Task Attributes 100% Inspection Observation of Performance Periodic Surveillance

SECTION 4 DELIVERABLES

4.1. Deliverables. The contractor shall provide the following deliverable as listed.

Item PWS Ref Title Distribution E H Initial Subsequent Deliverable 1 CMR KO, COR 1 1 N/A October 31st of each f iscal year

Deliverable 2 3.3.7 Compounding sterile isotopes

KO, COR 1 4 N/A 15 days from receipt of samples or receipt of task order

Deliverable 3 3.3.7.1 Ship 250 microliter aliquot of each lot to analytical lab

KO, COR 1 4 N/A 3 days from completion of compounding

Deliverable 4 2.4.2, 3.3.7.2, 3.3.7.3.1-3, 3.3.8

Isotope doses available for dispensing, w ith potency and sterility testing results

KO, COR 1 4 N/A 21 days from completion of compounding

SECTION 5 APPLICABLE DIRECTIVES, REGULATIONS, AND POLICIES

5.1. Environmental Requirements

5.1.1. Mandatory Compliance. Occupational Safety and Health Act and AR 200-1 Environmental Protection and Enhancement.

5.1.2. Non Mandatory Documents. Additional DoD and Army environmental program and regulations are available on-line at http://aec.army.mil.

5.3. Mandatory Compliance. Adherence to all guidelines and regulations governing the preparation for sterile IV solutions for use in human research volunteers. The contracted pharmacy must provide proof of sterility (USP <71>), fungal specific sterility, and endotoxin (USP<85>) testing of the isotope solutions for each lot prior to dispensing. All compounding must be done in compliance with USP <795> and USP <797> standards, as well as all state and Federal requirements as applicable. All aseptic compounding must occur in an ISO 5 primary engineering control (PEC) room located inside of an ISO 7 Buffer Room. The sterile lab, must be maintained, certified and validated in compliance with USP <797> standards. Additionally, the pharmacy http://aec.army.mil/ must demonstrate accreditation by the Pharmacy Compounding Accreditation Board (PCAB) and hold a state Board of Pharmacy license in Massachusetts.

5.3.1 Protection of Human Subjects and Adherence to Ethical Standards in Department of Defense (DoD)-Supported Research

The Contractor shall adhere to all applicable DoD regulations pertaining to Human Subjects Protection and Ethical Standards. Specifically, 32 Code of Federal Regulations (CFR) 219, National Defense, Protection of Human Subjects; Department of Defense (DoD) Instruction 3216.02, Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research, dated November 2011; Army Regulation (AR) 70-25 (under revision): Use of Volunteers as Subjects of Research, Headquarters, Department of the Army, dated 25 January 1990. Applicable US CFR regulations are:

Title 21, CFR Part 50 Protection of Human Subjects, Title 21 CFR Part 56, Institutional Review Boards; Title 21 CFR Part 812, Investigational Device Exemptions, April 1, 2014; Title 32 CFR Part 219, Protection of Human Subjects; Title 45 CFR 46, Protection of Human Subjects, April 1, 2014.

SECTION 6 DEFINITIONS

6.1. DEFINITIONS

6.1.1. 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.

6.1.2. CONTRACTING OFFICER. A person with authority to enter into, administer, and/or terminate contracts, and make related determinations and findings on behalf of the government. The Contracting Officer is the only individual who can legally bind the government.

6.1.3. CONTRACTING OFFICER'S REPRESENTATIVE (COR). An employee of the U.S. Government appointed by the contracting officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations.

This individual has authority to provide technical direction to the contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

6.1.4. DEFECTIVE SERVICE. A service output that does not meet the standard of performance associated with the Performance Work Statement.

6.1.5. DELIVERABLE. Anything that can be physically delivered, but may include non-manufactured things such as meeting minutes or reports.

6.1.6. PHYSICAL SECURITY. Actions that prevent the loss or damage of Government property.

6.1.7. QUALITY ASSURANCE. The government procedures to verify that services being performed by the contractor are performed according to acceptable standards.

6.1.8. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

6.1.9. QUALITY CONTROL. All necessary measures taken by the contractor to assure that the quality of an end product or service shall meet contract requirements.

6.1.10. SUBCONTRACTOR. One that enters into a contract with a prime contractor.

The Government does not have privity of contract with the subcontractor.

6.1.11. WORK DAY. The number of hours per day the contractor provides services IAW the contract.

6.1.12. WORK WEEK. Monday through Friday, unless specified otherwise.

ACRONYMS LIST

Acronym Definition AFARS Army Federal Acquisition Regulation Supplement

AKO Army Knowledge Online AOR Area Of Responsibility

ATCTS Army Training Certification Tracking System CFR Code of Federal Regulations COR Contracting Officer Representative

DFARS Defense Federal Acquisition Regulation Supplement DoD Department of Defense EIT Electronic and Information Technology

FAR Federal Acquisition Regulation FBI Federal Bureau of Information FSC Federal Supply Code FSS Federal Supply Schedule GFE Government Furnished Equipment GFI Government Furnished Information

GSA General Services Administration ID Identification IPT Integrated Product/Process Team IT Information Technology IV Intravenous KO Contracting Officier

NCIC-III National Crime Information Center Interstate Identification Index NLT No Later Than OCI Organizational Conflict of Interest

OPSEC Operational Security PCAB Pharmacy Compounding Accreditation Board PEC Primary Engineering Control PMO Project Management Office PRS Performance Requirements Summary PWS Performance Work Statement QASP Quality Assurance and Surveillance Plan QCP Quality Control Plan SOP Standing Operating Procedure

U.S.C. United States Code UIC Unit Identification Code US United States

USAMRAA United States Army Medical Research Acquisitions Activity

USAMRMC United States Army Medical Research and Materiel Command USARIEM United States Research Institute of Environmental Medicine

USP United Sates Pharmacopeia WAWF Wide Area Work Flow