Attachment 1 Fume Hood PWS_ 22-R-0007.pdf

PERFORMANCE WORK STATEMENT (PWS)

Inspection, Testing and Certification of Fume Hoods, Biosafety Cabinets, and

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PART 1

GENERAL INFORMATION

1. GENERAL: This is a non-personal service 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. The United States (U.S.) Government shall not exercise supervision or control over the Contractor’s employees performing the tasks herein. Such contract employees shall be accountable solely to the Contractor who, in turn shall be responsible to the U.S. Government.

1.1 Description of Services/Introduction: The contractor shall provide all necessary trained/Original Equipment Manufacturer (OEM) certified experienced personnel, labor, tools, specialized tools, diagnostic equipment, material, supplies, transportation, travel costs, parts and equipment, excluding expendable items to perform services referenced in para. 1.5 of this performance work statement (PWS).

1.2 Background: Irwin Army Community Hospital utilizes fume hoods, biosafety cabinets and cleanrooms for sterile compounding of medications and handling possible infectious organisms. In order to perform these functions the equipment and rooms must be tested and certified for safety and maximum performance.

1.3 Objectives: Equipment will be tested and certified in accordance to original equipment manufacturer (OEM). Pharmacy compound room and Biological Safety Cabinet (BSC) testing and certification will follow standards United States Pharmacopeia (USP) 797, USP 800, National Sanitation Foundation/American National Standards Institute (NSF/ANSI) 49, Occupational Safety and Health Administration (OSHA), National Institutes of Health/Centers for Disease Control (NIH/CDC), Department of the Army Pamphlet 385-69, Joint Commission Standards.

1.4 Scope: The Contractor shall furnish all certified field services personnel, labor, travel, and equipment required perform all work necessary to test and certify the equipment and rooms located at Irwin Army Community Hospital at Fort Riley, Kansas as outlined below. This is a Firm Fixed Price (FFP) Service Contract with a Base Year and two (3) Option Year(s).

1.5 Equipment Listing:

Table 1 Manufacturer Nomenclature Serial

Number Location

Labconco Cabinet, Biological Safety Class II 140998216D

Environmental Health (Caldwell)

BLDG 7665

Labconco Cabinet, Biological Safety Class II 121168107

Main Pharmacy room number:

1A139/1H139

Labconco Cabinet, Biological Safety Class II 121168329C Clinical Pathology room number: 2A159/2H314

Labconco Cabinet, Biological Safety Class II 121168336C Clinical Pathology room number: 2A159/2H314

Labconco Laboratory Hood, Chemical Fume 140491151D Clinical Pathology room number: 2A157/2H301

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Labconco Laboratory Hood, Chemical Fume

140187192C Main Pharmacy room number: 1A139/1H139

Labconco Laboratory Hood, Chemical Fume, Ductless 150407326C Operative Service room number: 2B199

Sakura Finetek Autopsy/Dissection Station 054531 Clinical Pathology room number: 2A157/2H301

Nuaire Compounding Aseptic Isolator 207451080221 Main Pharmacy room number: 1A139/1H135

1.6 General Information:

1.6.1 Quality Control Plan (QCP): The Contractor shall develop, implement, and maintain a QCP and program to ensure all work described in this contract is performed at or above the standard defined in the Performance Requirements Summary (PRS). The QCP is developed by the contractor for its internal use to ensure that it performs and delivers high-quality service. The contractor’s QCP is the means by which the contractor ensures all work complies with the requirements of the contract. The QCP identifies and corrects potential and actual problem areas throughout the entire scope of the contract.

1.6.1.1 The contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The QCP shall be submitted with the Offer. The final QCP is due within thirty (30) days of contract award. After acceptance of the QCP, the contractor shall receive the contracting officer’s (KO) acceptance in writing of proposed changes to the QC procedures. The contractor shall submit QCP changes within five (5) days to the KO and Contracting Officer’s Representative (COR) for review and approval prior to implementation.

1.6.1.2 The Quality Control Plan shall address as a minimum:

1.6.1.2.1 Inspection Program. Included shall be a quality control inspection program covering all general and specific tasks included in the contract scope of work. It shall specify tasks or areas to be inspected on a scheduled or unscheduled basis, the manner in which inspections are to be conducted, the titles of the individuals who will perform the inspections, and the percentage of the work that will be inspected on a recurring basis. In developing this inspection program, the Contractor shall identify the key activities and associated characteristics in each process that have a significant influence on specific services and provide for methods for evaluation of the selected characteristics.

1.6.1.2.2 Deficiency Identification. The QCP shall include a method of identifying deficiencies in the quality of services performed before the level of performance becomes unacceptable as defined in the PRS.

This shall contain processes for corrective action without dependence upon Government direction.

1.6.1.2.3 Deficiency Correction. The program shall contain process control and process performance measurement procedures that shall include how the Contractor shall implement preventive corrective actions. The Contractor shall demonstrate that it has designed quality into the delivery of services thereby mitigating the risk(s) associated with delivery of deficient or nonconforming services.

1.6.1.2.4 Documentation and Enforcement. The QCP shall include a method of documenting and enforcing quality control operations of both prime contractor and subcontractor work; including inspection and testing.

1.6.1.2.5 Trend Analysis. The QCP shall include a method of performing trend analysis and assessments through the use of metrics.

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1.6.1.2.6 Surveillance Methods. The QCP shall contain specific surveillance techniques for all contract services. The surveillance methods shall be comprehensive and adaptable to the reporting system of the plan.

1.6.2 Quality Assurance (QA): The government shall evaluate the contractor’s performance under this contract in accordance with (IAW) the Quality Assurance Surveillance Plan. This plan is primarily focused on what the Government must do to ensure that the contractor has performed IAW the performance standards and contract quality requirements are met. Contract quality requirements” means the technical requirements in the contract relating to the quality of the product or service and those contract clauses prescribing inspection, and other quality controls incumbent on the contractor, to ensure the product or service conforms to the contractual requirements. It defines how the performance standards will be applied, the frequency of surveillance, the performance threshold, and deductions, if applicable.

1.6.3 Recognized Holidays: Normal working hours are between 7:30am to 4:30pm Monday through Friday excluding the Federal and Legal Public Holidays listed below. The Contractor is not required to work on the below listed Holidays.

New Year’s Day .......................................................... 1st of January Martin Luther King, Jr.’s Birthday rd Monday in January President’s Day rd Monday in February Memorial Day .............................................................. Last Monday in May Juneteenth .................................................................... 19th of June Independence Day ....................................................... 4th of July Labor Day st Monday in September Columbus Day nd Monday in October Veteran’s Day .............................................................. 11th of November Thanksgiving Day th Thursday in November Christmas Day ............................................................. 25th of December

1.6.3.1 Training Holidays: When a holiday falls on a Saturday, the preceding Friday will be observed as the holiday. When a holiday falls on a Sunday except for Independence Day, the following Monday will be observed as the holiday.

1.6.4 Hours of Operation: The contractor is responsible for conducting business between the hours of 7:30am to 5:00pm Monday through 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. For other than firm fixed price contracts, the contractor will not be reimbursed when the government facility is closed for the above reasons. 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.

1.6.5 Place of Performance: The work to be performed under this contract will be performed at Irwin Army Community Hospital (IACH), 650 Huebner Rd, Fort Riley, KS 66442 and Caldwell Clinic Bldg 7665, Fort Riley, KS 66442.

1.6.6 Type of Contract: The Government anticipates the award of a Firm-Fixed Price (FFP) type contract.

1.6.7 Access and General Protection Policy and Procedures:

1.6.7.1 FPCON : In addition to the changes otherwise authorized by the changes of clause of contract, should the US Government Force Protection Condition (FPCON) at any individual installation change, the Government may require changes in contractor security matters or process in accordance with DoDI 2000.16.

During FPCONs Charlie and Delta, only contract services that have been deemed “mission essential” by the Government will continue. Contract services will resume when the FPCON is reduced to Bravo or lower.

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1.6.7.1.1 HPCON: The contractor shall be responsible for adhering to the installation’s Health Protection Condition (HPCON) guidance regarding the COVID-19 precautionary measures.

1.6.7.2 Physical Security: The contractor shall be responsible for safeguarding all government equipment, information, and property provided for contractor use.

1.6.7.3 Escorts: Reserved.

1.6.7.4 Personnel Security Clearance Requirements: Reserved.

1.6.7.4.1 Reserved.

1.6.7.5 Background Checks: The Contractor shall ensure contractor employees and subcontractor employees performing services under this contract have passed a security check conducted by the State Police Department of their U.S. residence. Security checks that have been completed as part of a personnel security clearance background investigation, or a previous background check that was a condition of employment, meet this requirement. Documentation of these checks will be made available to the KO or COR upon request. The Government retains the right to exclude any employee from performance of duties under this contract if a background security check reveals an employee is a security risk. The exclusion of an employee for security reasons will not relieve the Contractor from performance of services required under this contract. If the Government determines additional background checks are required, at a minimum, and upon request from the Government, the Contractor shall provide to the KO or COR, the following information on any contractor or subcontractor employee performing services under this contract:

• Full birth name

• Married name (if applicable)

• SSN or local equivalent (ID card number)

• Date of birth

• Place of birth (city, country)

1.6.7.5.1 Background Check Notification Requirements: If a background check on any employee or subcontractor employee performing services under this contract, whether the check was conducted as a condition of employment or as part of the contract with the Government, reveals any information from any source (including host country law enforcement) of criminal activity by Contractor employees, subcontractors, or subcontractor employees, the Contractor shall immediately notify the KO and COR of that information. The Contractor shall make notification of:

(1) Traffic violations, other than parking, will be reported to the KO or COR only if the contract is for drivers for the Government;

(2) Any suspicious activity by Contractor employees, subcontractors, or subcontractor employees the Contractor believes may pose a risk to U.S. or host nation national security or imminent risk of deadly bodily harm to any person; and

(3) Any actions taken against Contractor employees, subcontractors, or subcontractor employees pursuant to this requirement.

1.6.7.5.2 Remedies. In addition to other remedies available to the Government, the Contractor’s failure to comply with the requirements of this paragraph my result in requiring the Contractor to remove a Contractor employee or employees from the performance of the contract.

1.6.7.5.3 Subcontracts. The Contractor shall include the substance of this paragraph and the preceding paragraph in all subcontracts.

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1.6.7.6 Uncleared Contractor Common Access Card (CAC) Credentialing and Access Procedures.

1.6.7.6.1 Contractor Common Access Card (CAC) Eligible Requirements: Reserved.

1.6.7.6.1.1 Federal Installation/Facility Access: Reserved.

1.6.7.6.2 Contractor Non-CAC Eligible Requirements for DOD Facility and Installation Access.

Contractor and all associated sub-contractors employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (TSDB) (Army Directive 2014-05/AR 190-13), applicable installation, facility and area commander installation/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.

1.6.7.6.2.1 Contractor personnel or any representatives of the Contractor entering Fort Riley shall abide by all security regulations in AR 380-5 and shall be subject to security checks.

1.6.7.6.2.2 Installation Access. All Contractor furnished vehicles and equipment must enter the installation through the authorized access points to Ft. Riley and enter Camp Funston via the main access road (12th St Entry Control Point. All Contractor personnel driving contractor furnished vehicles shall maintain and have on their person, a valid state driver’s license, current vehicle registration and proof of insurance card.

Contractor and Contractor personnel shall comply with Ft Riley Regulation 190-5, Traffic Supervision and Installation Traffic Codes, for the registration of Contractor owned vehicles and shall ensure that their employees comply with Ft Riley Regulation 190-5 for the registration of privately owned vehicles.

Passenger(s) in any of the vehicles will be required to show a valid photo ID/State driver’s license to enter the installation. Contractor shall also have in hand the contract to provide to security personnel if requested for verification.

1.6.7.6.2.3 Vehicle Identification. All Contractor and Subcontractor owned vehicles and equipment used in performance of this contract shall bear the Contractor or Subcontractor’s Name, and Logo if used, while working on Fort Riley. As a minimum, The company name and area code phone number, and Logos if used, shall be applied to both sides of the vehicles and equipment.

1.6.7.7 Access to Government Information Systems: Reserved.

1.6.7.8 Key Control: Reserved.

1.6.7.9 Lock Combinations: Reserved.

1.6.8 Post Award Conference/Contract Periodic Progress Meetings: The Contractor shall attend the post award conference convened by the contracting activity or contract administration office IAW Federal Acquisition Regulation (FAR) Subpart 42.5. The KO, COR, with other Government personnel, as appropriate, may meet periodically with the Contractor to review the Contractor's performance. At these meetings the KO 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.

1.6.9 Contracting Officer Representative (COR): The COR will be identified by separate letter. The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions: ensure 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

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Contractor's performance and notifies both the KO 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 order.

1.6.10 Reserved:

1.6.11 Reserved:

1.6.12 Identification of Contractor Employees: Contractor employees shall identify themselves as Contractor personnel and shall avoid representing themselves as Government employees. This identification includes meeting attendance, answering Government telephones, email communications, and working in other situations where Contractor status is not obvious. Contractor personnel identification shall be easily identifiable through the display of badges, name tags, lanyards, etc. Contractor personnel are not required to obtain Government badges or identification in the performance of this requirement.

1.6.12.1 Badging of Contractor Employees: Reserved.

1.6.12.2 Uniform: No specific uniform is required. However, use the following guidelines regarding dress code. All Contractor personnel, when located on government installations or property, shall be well groomed, well mannered, and properly dressed. Well-groomed personnel shall be neat and clean in appearance. Proper attire shall not include shorts, or any variation of shorts, spandex pants, tank tops, sleeveless apparel without a jacket, t-shirts, or similar casual attire.

1.6.13 Contractor Travel: Reserved.

1.6.14 Other Direct Costs (ODC): Reserved.

1.6.15 Data Rights: Reserved.

1.6.16 Non-Disclosure Requirements: Performance under this contract may require the Contractor to access data and information proprietary to a Government agency, another Government Contractor, or of such nature that its dissemination or use other than as specified in this work statement would be adverse to the interests of the Government or others. Neither the Contractor, nor Contractor personnel, shall divulge, nor release data or information developed, or obtained under performance of this work statement, except to authorize Government personnel or upon written approval of the KO. The Contractor shall not use, disclose, or reproduce proprietary data, which bears a restrictive legend, other than as specified in this PWS. All documentation showing individual names or other personal information shall apply, and shall be controlled and protected under the provisions of the Privacy Act of 1974, Public Law 93-579, 5 United States Code (U.S.C.) Section 552a.

1.6.16.1 Non-Disclosure Statements: Reserved.

1.6.16.2 Advertisement and Social Media: The Contractor shall NOT post information to public website or social media locations, personal or professional, that in any way disclose names, locations, hotel data, participants, discussions, pictures, etc. before, during or after the contract period of performance without the express consent of the Government. The use of propaganda violates DOD Commercial Use of Imagery Guidelines stated at (http://www.defenseimagery.mil/products/DODimagery/commercialuse.html). The http://www.defenseimagery.mil/products/dodimagery/commercialuse.html

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Contractor shall not cite any information (e.g., contract information, pictures, locations, etc.) obtained through this contract on any marketing tools to include its company website.

1.6.16.3 INFORMATION ASSURANCE: At no time will the Contractor or associated sub-contractor employees transmit government documents or information over using methods that do not meet the security requirements specified in the National Institute of Standards and Technology (NIST) Special Publication (SP) 800-171, "Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations" such as personal electronic mail accounts, public digital data storage sites (cloud storage), social media platforms or instant messaging. Approved government sites such as U.S. Army Aviation and Missile Research Development and Engineering Center (ARMDEC) Safe Exchange at https://safe.amrdec.army.mil/SAFE/About.aspx, or All Partners Access Network (APAN) at https://community.apan.org/, or other transmission means determined by the government must be used.

1.6.17 Organizational Conflict of Interest (OCI): Contractor and subcontractor personnel performing work 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 Organizational Conflict of Interests (OCI) 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 and in the event the KO unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, the KO may affect 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.

1.6.17.1 Hiring Off-Duty Active Military. The Contractor should use caution when hiring off-duty active military personnel under this contract. Those individuals may be subject to permanent change of station (PCS) orders, change in duty hours, or deployment. Military Reservists and National Guard members may be subject to call to active duty. The abrupt absence of these personnel could adversely affect the Contractor's ability to perform. The absence of the described personnel at any time shall not constitute an excuse for nonperformance under this task order.

1.6.18 Phase-in/Phase-Out (PIPO) Period: Reserved.

1.6.19 General Training Requirements:

1.6.19.1 Anti-Terrorism (AT) Level I Training. The Contractor shall complete AT Level I Training within 30 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever applies, or 30 calendar days after employment of new personnel, all Contractor employees, including subcontractor employees, who are employed under the contract shall complete AT Level I awareness training within 30 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever applies. The contractor shall submit certificates of completion for each affected Contractor employee and subcontractor employee to the COR or KO within ten (10) calendar days after completion of training by all employees and subcontractor personnel. For Common Access Card (CAC) holders, AT Level I awareness training is available at https://jkodirect.jten.mil, course number “JS-US007-14”. For non-CAC holders, AT Level I awareness training is available at http://jko.jten.mil/courses/atl1/launch.html (this standalone version is intended for non-CAC users without a JKO account only). Training must have been completed within the last 12 months and maintained yearly thereafter. If training cannot be conducted on the website, the Contractor will coordinate with the local AT Officer at their assigned location for classroom training by a Level 2 trained AT Officer and a copy of either the training certificate or the training attendance roster signed by the AT Officer will be maintained by the Contractor. Verification of the training will be provided to the COR or KO within ten (10) calendar days after completion of the training.

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1.6.19.2 OPSEC Awareness: If the Contractor, or a subcontractor, or employees of either disclose any information that disrupts or harms the Government's operations or activities, then the Government retains the right to exclude any employee from performance of duties under this contract. The exclusion of an employee for security reasons will not relieve the Contractor from performance of services required under this contract. By way of example, personnel shall not sketch or take photos of government facilities or activities, unless related to service to be provided. All government paper products and removable digital storage material that is received, generated, or stored during the contract will be destroyed completely when no longer needed to preclude recognition of information.

1.6.19.3 Information Assurance (IA) Training: Reserved.

1.6.19.4 Information Assurance (IA)/Information Technology (IT) Training: Reserved.

1.6.19.5 Threat Awareness Reporting Program (TARP Training): Within 30 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever applies, or 30 calendar days after employment of new personnel, all Contractor employees, including subcontractor employees, who are employed under the contract and require a security clearance, shall complete TARP training within 30 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever applies. The Contractor shall submit certificates of completion for each affected Contractor employee and subcontractor employee to the COR within ten (10) calendar days after completion of training by all employees and subcontractor personnel. TARP training is available at the Army Learning Management System (ALMS) https://www.lms.army.mil/. Training must have been completed within the last 12 months and maintained yearly thereafter. If training cannot be conducted on the website, the Contractor will coordinate with the local Counter Intelligence (CI) Officer at their assigned location for classroom training and a copy of either the training certificate or the training attendance roster signed by the CI Officer will be maintained by the Contractor. Verification of the training will be provided to the Contracting Officer (KO) or Contracting Officer Representative (COR) within ten

(10) calendar days after completion of the training.

1.6.19.6 iWATCH Training: 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 30 calendar days of new employees commencing performance, with the results reported to the COR and the Contracting Office NLT 30 calendar days after contract award. See Exhibit A iWATCH Training.

1.6.19.7 OPSEC Training: All Contractor employees and sub-Contractor employees performing services under this contract will complete Level I OPSEC training within 30 calendar days of employment under this contract. OPSEC Level I training is available at https://jkodirect.jten.mil, course number “EUC-ECJ6- 110-N-LB”. Training must have been completed within the last 12 months and maintained yearly thereafter. If training cannot be conducted on the website, the Contractor will coordinate with the local OPSEC Officer at their assigned location for classroom training by a Level 2 trained OPSEC Officer and a copy of either the training certificate or the training attendance roster signed by the OPSEC Officer will be maintained by the Contractor. Verification of the training will be provided to the COR or KO upon request.

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PART 2

DEFINITIONS & ACRONYMS

2. DEFINITIONS AND ACRONYMS:

2.1 Definitions:

2.1.1 Contractor. The total contractor organization or a separate entity of it; such as an affiliate, division, or plant that performs its own purchasing.

2.1.2 Contracting officer (KO). A person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings.

2.1.3 Contracting Officer’s Representative (COR). An individual designated and authorized in writing by the contracting officer to perform specific technical or administrative functions.

2.1.4 Defective Service. A service output that does not meet the standard of performance associated with the Performance Work Statement.

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

2.1.6 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 Key Personnel listed in 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.

2.1.7 Performance Work Statement (PWS). A statement of work for performance-based acquisitions that describes the required results in clear, specific, and objective terms with measurable outcomes.

2.1.8 Physical Security. Protection of the perimeter area, government property, and assets that prevent the loss or damage of Government property.

2.1.9 Quality Assurance. The various functions, including inspection, performed by the government to determine whether a Contractor has fulfilled the contract obligations pertaining to quality and quantity.

2.1.10 Quality Assurance Surveillance Plan (QASP). A plan describing how the agency will survey, observe, test, sample, evaluate and document the Contractor’s performance in meeting critical performance standards identified in the contract.

2.1.11 Quality Control (QC). Tasks performed by the Contractor to improve the quality of the organization’s output.

2.1.12 Shall. An imperative command; has a duty to or is required to. Denotes that a regulation must be followed unless the contracting officer has obtained a deviation.

2.1.13 Subcontractor. Any supplier, distributor, vendor, or firm that furnishes supplies or services to or for a prime contractor or another subcontractor.

2.1.14 Work Day. The number of hours per day the Contractor provides services in accordance with the contract.

2.1.15 Work Week. Monday through Friday, unless specified otherwise.

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2.2 Acronyms:

ALMS Army Learning Management System ANSI American National Standards Institute AOR Area of Responsibility AR Army Regulation ATCTS Army Training Certification Tracking System AT Anti-Terrorism CAC Common Access Card CFR Code of Federal Regulations CI Counter Intelligence CLIN Contract Line Item Number CONUS Continental United States (excludes Alaska and Hawaii) COR Contracting Officer Representative DD Form 254 Department of Defense Contract Security Requirement List DOD Department of Defense DODD Department of Defense Directive DODI Department of Defense Instruction FAR Federal Acquisition Regulation FHP Force Health Protection FCG Foreign Clearance Guide FY Fiscal Year GFE Government Furnished Equipment GFP Government Furnished Property IA Information Assurance IACH Irwin Army Community Hospital IAW In Accordance With IT Information Technology JPAS Joint Personnel Adjudication System JTR Joint Travel Regulation KO Contracting Officer KS Contract Specialist LOA Letter of Authorization NCIC-III National Crime Information Center Interstate Identification Index NIST National Institute of Standards and Technology ODC Other Direct Costs OCI Organizational Conflict of Interest OCONUS Outside Continental United States (includes Alaska and Hawaii) ODC Other Direct Costs OSHA Occupational Safety and Health Administration OPSEC Operation Security PIPO Phase In/Phase Out PRS Performance Requirements Summary PWS Performance Work Statement QA Quality Assurance QASP Quality Assurance Surveillance Plan QCP Quality Control Program RA Requiring Activity SCR Service Contract Reporting SOP Standard Operating Procedures SPOT Synchronized Predeployment and Operational Tracker TE Technical Exhibit TSDB Terrorist Screening Data Base U.S.C. United States Code

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PART 3

GOVERNMENT FURNISHED PROPERTY AND SERVICES

3.1. Government Furnished Property:

3.1.1 The equipment covered under this contract will be made available to the Contractor for the purpose of scheduled services.

3.1.2 All rooms where the equipment is located will be made available to the Contractor

3.1.3 The Government shall make available the following Government points of contact for questions and to set up service appointments.

Primary POC: Michelle Trussell POC: Michael Cossey Officer in Charge: CW3 David Turner Non-Commissioned Officer in Charge: SFC Hai Vu Truong

PART 4

CONTRACTOR FURNISHED FACILITIES AND EQUIPMENT

4.1. Contractor Furnished Facilities and Equipment – General

4.1.1 Only the property and services referenced in Section 3 (Government Furnished Property) shall be provided to the Contractor to perform required services. All other property and services required in the performance of this contract shall be furnished by the contractor.

4.1.1.1 Contractor responsibilities include:

• OEM certified and licensed technicians capable of performing the testing and certification of the equipment listed in this PWS.

• Controlling Environment Testing Association (CETA) certified/licensed technician capable of performing testing and certification of the clean rooms, and buffers.

• Tools

• Contractor technician shall ensure that testing equipment shall meet calibration requirements in accordance with manufacturer recommendations.

4.1.2 The performance of all services shall meet or exceed the specifications of the (OEM). Pharmacy compound room and BSC testing and certification will follow standards USP 797, USP 800, NSF/ANSI 49, OSHA, NIH/CDC, Department of the Army Pamphlet 385-69, and Joint Commission Standards.

4.1.3 During the contracting time frame, pharmacy compound room and BSC testing and certification will follow the guidance of the most current approved version of USP 797, USP 800, NSF/ANSI 49, OSHA, NIH/CDC, CETA and the manufacturer's specifications. Contractor will be knowledgeable of changes within the USP 797, USP 800, NSF/ANSI 49, OSHA, NIH/CDC, CETA and able to certify compound rooms and BSC according to those guidelines. If the guidance varies between certifying guidelines, the pharmacy will instruct which guidelines to follow the most stringent guidelines will be followed unless the pharmacy chooses a lesser standard because of manufacturer or engineering limitations. If the compound rooms or the BSC’s were not engineered to meet those guidelines, the certification will based on the manufacturer’s guidelines for the BSC or the engineering design guidelines for the compound room.

4.1.4 Invoicing and Payment: Payment will be made by Defense Finance and Accounting Service, Indianapolis, after receipt of services. Contractor submits their 2-n-1 invoice in the Procurement Integrated

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Enterprise Environment (PIEE) DFAS Indianapolis. Government Payment will only be authorized for services actually rendered. Advance payments under this contract are not authorized. Information regarding invoicing is available on the Internet at https://piee.eb.mil.

PART 5

SPECIFIC TASKS

5. Specific Tasks: Contractor shall perform inspection of the equipment and clean rooms referenced PWS section 1 para. 1.1, Table 1. Pharmacy compound room and BSC testing and certification Inspection shall meet Joint Commission standards and will follow latest approved standards USP 797, UDP 800, NSF/ANSI 49, OSHA, NIH/CDC, and OEM specifications.

5.1 Testing: Contractor shall perform testing of the fume hoods, biosafety cabinets and clean rooms to include testing of clean room high efficiency particulate air (HEPA) filtration system. Testing and certification shall be completed one week prior to previous certification expiration date.

5.1.1 BSC Testing shall include the following:

• Inflow velocity measurements – ensures proper inflow is maintained for operator protection and environmental protection.

• Downflow velocity measurements – documents the air in the work area is unidirectional and functioning as designed, preventing cross contamination, and providing product protection from the environment.

• HEPA filter integrity testing – documents leakage or defects and ensures HEPA filters provide required filtration to prevent both product and environmental contamination.

• Smoke pattern testing – qualitatively verifies airflow directions using a small source of visible fog.

• Site installation testing and alarm calibration – confirms alarm performance and assesses installation of units for NSF and OSHA compliance.

• Viable sampling shall be done following the most current USP 797 guidelines, to include growth medium, incubation periods, temperatures and identifications of all air growth to the genres level (level 1) and identification of surface growth that exceeds the acceptable level to the genres level (level 1).

5.2 Compounding rooms will be certified according to the latest approved version of USP 797, USP 800, NSF/ANSI 49, OSHA, NIH/CDC, and CETA. Testing shall include:

• Airflow test - turbulent airflow

• Unidirectional airflow

• Room pressurization

• Airflow Displacement

• HEPA Filter Installation Leak Test

• Airborne Non-Viable Particle Count (surface and air)

5.3 Testing Failure: Deficiencies noted shall be reported immediately to Logistics and Chief of Pharmacy for proper corrective actions. The Government is responsible for correcting issues found during certification testing. The requalification test cost will be the responsibility of the Government.

5.4 Certification: When inspections and tests conform to OEM, Army Regulatory and Joint Commission Standards, the Contractor shall provide certification documentation to the Government Point of Contact (GPOC) provided at the time of service.

5.5 Parts Replacement: Contractor shall have a sufficient supply of parts available to complete service.

Parts shall meet or exceed OEM standards.

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5.6 Irwin Army Community Hospital included services:

5.6.1 Pharmacy:

• Biological Safety Cabinet Certification Class II B2

• Laminar Flow Hood Certification

• Compounding Aseptic Isolator Certification

• Hood/Isolator Particle Count Classification

• Hood/Isolator Viable Air Sampling per USP<797>

• Hood/Isolator Viable Surface Sampling per USP<797>

• Standard Airflow Smoke Pattern Testing

• Room Air Exchanges per Hour

• Room Differential Pressure Testing

• Room Particle Count Classification

• Room Viable/Nonviable Air Sampling per USP<797>

• Room Viable/Nonviable Surface Sampling per USP<797>

• Temperature Testing

• Humidity Testing

• Terminal HEPA Filter Volume Testing

• Terminal HEPA Integrity Test

• Report Generation

• Initial Report Set Up

• Service Call Truck Charge

5.6.2 Laboratory

• Biological Safety Cabinet Certification

• Fume Hood Certification

• Grossing Station Certification

• Service Call Truck Charge

5.6.3 Caldwell Clinic

• Balance Enclosure Certification w/Exhaust HEPA

• Fume Hood Certification

• Service Truck Charge

5.7 Service Report: Upon completion of any on-site services by the contractor’s service representative, a written service report shall be provided to the Clinical Engineering staff. In the event all information is not available to the contractor’s service representative when services are performed, the initial service report shall include all available information.

5.7.1 The formal report shall be received within 48 hours of service completion. Report shall include:

• Equipment identification data: system nomenclature, room number, location, model and serial number.

• Documentation of test results in an informative and comprehensive report shall be provided as a formal completion to the certification process.

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• Name, address and contact information for the certifying organization also listing key personnel with appropriate accreditations.

• Confirming remark that the most current version of regulations and guidelines was referenced for this certification and the actual date the certification was completed.

• Simple and clear method of identification of the approximate location of the collected data in relation to the physical layout of the equipment or facility tested, including specific and clear nomenclature for the data locations.

• Explanation of test procedure used for data collection and justification for any deviations from established industry practices encountered during the certification process.

• Collected data will be compared to expected values or specific equipment performance criteria established in Standard Operating Procedures supplied by the Government. In the absence of client SOPs, the certifying organizations SOPs or industry accepted standards, recommended practices and manufacturer’s specifications would be used.

• Provide a list of equipment utilized in data collection to include make, model, serial number, and calibration date and when requested a facsimile of the current calibration documentation for each piece of equipment, when applicable.

• Test equipment used for certification of sterile compounding facilities should be calibrated on a calibration frequency not to exceed 12 months or more frequently if recommended by the manufacturer. Calibration certificates should be provided upon request by the customer for all calibrated test equipment.

5.8 Forms: After performing on-site Inspection, Testing, and Certification services, the Government technician or contractor will affix and/or update DD Form 2163 (Medical Equipment Verification/Certification) in accordance with the instructions provided in TB 38-750-2, or by the clinical engineering activity’s internal SOP. The documentation shall be included with equipment shipment when equipment is returned to contractor for service.

5.9 Damage: The Contractor is not responsible for the sustainment of MD/MDS listed when damage resulted from acts of God, or Government neglect/misuse/abuse, or when services were conducted by personnel other than the contractor.

5.10 Compliance: The Contractor shall comply with applicable federal, state, and local laws and regulations.

5.11 Services Outside of the Scope: The Contractor may perform only services covered in the scope of the task order. Any requests for services outside of the terms and conditions of the task order are not authorized for action by the Contractor. The Contracting Officer maintains the sole authority to determine scope.

PART 7

ATTACHMENT/TECHNICAL EXHIBIT LISTING

7. Attachment/Technical Exhibit List:

7.1 Attachments:

7.1.1 Attachment 1 – Performance Requirements Summary

7.1.2 Attachment 2 – Deliverables Schedule

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TECHNICAL EXHIBIT A

Title if Used

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ATTACHMENT 1

Performance Requirements Summary The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The standard should relate to timeliness, quality, or quantity (metrics) of service required by the Contractor is stated in the PWS verbiage. 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)

Standard Performance Threshold (This is the maximum error rate. It could possibly be “Zero deviation from standard”)

Incentive (Positive and/or Negative)

1. Combating Trafficking in Persons FAR 52.222-50 c

The Contractor shall Notify its employees of

a. The United States Government's zero tolerance policy described in paragraph

(b) of this clause The actions that will be taken against employees for violations of this policy. Such actions may include, but are not limited to, removal from the contract, reduction in benefits, or termination of employment.

100% Compliance Contractor compliance rate shall be utilized as objective evidence of contract compliance and documented into the CPAR system;

contractor shall re-perform the service

PRS # 1.

Equipment and Clean Rooms PWS para 1.5 and 5.1

Contractor shall perform testing, and certification for the rooms and equip. listed in PWS.

100% Compliance Non-conforming services will result in non-conforming reports issued to Contractor and potential negative FAPIIS report.

PRS #2

Invoicing PWS para. 4.1.4.

Contractor shall submit 2-n-1 invoice to PIEE

100% Compliance Non-conforming services will result in non-conforming reports issued to Contractor and potential negative FAPIIS report.

PRS #3

Testing and Certification Regulations PWS para. 5

Contractor shall comply to standards and regulations referenced in this PWS

100% Compliance Non-conforming services will result in non-conforming reports issued to Contractor and potential negative FAPIIS report.

PRS #4

Biological Safety Cabinets and Fume Hoods

Tests to be performed will include the tests listed in this PWS

100% Compliance Non-conforming services will result in non-conforming reports issued to Contractor and

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PWS para. 5.1.1, 5.2, 5.6.1, 5.6.2., 5.6.3.

potential negative FAPIIS report.

PRS #5

Service Report PWS para. 5.7

Service Report shall include information listed in 5.7.1 of this

PWS

100% Compliance Non-conforming services will result in non-conforming reports issued to Contractor and potential negative FAPIIS report.

PRS #6

Certification Documentation PWS para.

5.4

Contractor shall supply certification documentation as required

100% Compliance Non-conforming services will result in non-conforming reports issued to Contractor and potential negative FAPIIS report.

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ATTACHMENT 2

Deliverables Schedule

Deliverable Frequency # of Copies Medium/Format Submit To

QCP

[PWS para. 1.6.1]

Initial: Within 30 days of contract award.

Updates: within 5 days.

1 copy is required. Microsoft Office Outlook Email CONTRACTING

OFFICER:

CHRISTOPHER

.A.RICHIE.CIV@AR

MY.MIL

CONTRACT

SPECIALIST:

TRAVIS.E.ENGLE.CI

V@ARMY.MIL

CONTRACTING

OFFICER’S

REPRESENTATIVE

(COR):

MICELLE.C.TRU

SSELL.CIV@MAI

L.MIL

Anti-Terrorism Certificates

[PWS para.1.6.19.1]

Initial: Within 30 days of contract award.

Updates: annually thereafter.

[Same as above.] [Same as above.] [Same as above.]

OPSEC Certificates

[PWS para. 1.6.19.7]

[Same as above.] [Same as above.] [Same as above.] [Same as above.]

TARP Certificates

[PWS para.1.6.19.5]

[Same as above.] [Same as above.] [Same as above.] [Same as above.]

Maintenance Report Within 48 hours after of Semi-annual Maintenance

1 Email COR

Certification documents for all equipment in rooms stated in the PWS 5.4.

Within 48 hours after of Semi-annual Maintenance

1 Email COR

Certification documents for test measurement diagnostic equipment at IACH (TMDE) PWS Para 5.7.1.

Within 48 hours after of Semi-annual Maintenance

1 Email COR mailto:Christopher%20.a.richie.civ@army.mil mailto:Christopher%20.a.richie.civ@army.mil mailto:Christopher%20.a.richie.civ@army.mil mailto:travis.e.engle.civ@army.mil mailto:travis.e.engle.civ@army.mil

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Deliverable Frequency # of Copies Medium/Format Submit To Airborne Partial count Certification for Clean rooms PWS Para 5.2.1.

Within 30 days after of Semi-annual Maintenance

1 Email COR

Viable sampling certification for air and surface sampling for cabinets. PWS Para 5.1.1.

Within 30 days after of Semi-annual Maintenance