Attachment 1 PWS 02Mar06 W911RX26QA017.pdf

Performance Work Statement (Includes associated Performance Requirements Summary (PRS)

For Inspection, Testing and Certification of Fume Hoods, Biosafety Cabinets, and Clean Rooms 10 May 2026

Part 1 General Information

1. General: This is a non-personal service(s) contract under which the personnel rendering the service(s) 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.

1.1. Description of Services/Introduction: This is a non-personal services requirement for on-site semi-annual inspection, testing and certification of fume hoods, biosafety cabinets (BSC), and testing of the clean/compounding rooms at Irwin Army Community Hospital and Environmental Services.

1.2. Background: The facilities BSC’s, fume Hoods, autopsy/grossing hood, isolators and cleanrooms must be tested and certified to stay in compliance of Federal regulations.

1.3. Scope: The Contractor shall provide all necessary trained/OEM certified experienced personnel, labor, tools, specialized tools, diagnostic equipment, material, supplies, transportation, and travel costs required to perform the testing and certification of fume hoods, biological safety cabinets, grossing hood, compounding isolator. Contractor shall also provide testing, viable/non-viable surface and air sampling, particle counts and identification of any samples of microorganisms found.

1.4. Objectives:

• Certification of Fume Hoods

• Certification of Biological Safety Cabiniets

• Certification of Isolator

• Certification of Grossing Hood

• Certification of Clean Rooms

1.5. General Information:

1.5.1. Quality Control: Quality control is the responsibility of the Contractor. The Contractor is responsible for the delivery of quality services/supplies to the Government. The Contractor shall inform the COR in writing of issues or potential issues that might affect the performance within 1 week of identifying those issues.

1.5.2. Quality Assurance: The Government will evaluate the Contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan is primarily focused on what the Government must do to ensure that the Contractor has performed in accordance with the performance standards.

It defines how the performance standards will be applied, the frequency of surveillance, and the acceptable quality levels (performance thresholds).

1.5.3. Recognized Holidays: The following provides information on recognized holidays for the purpose of the PWS. If submittal of any documentation (e.g. deliverables, submittals, etc.) deadlines fall on a holiday, the closest workday prior to the holiday will apply as the deadline for submittal.

1.5.3.1. U.S. Holidays: Work shall not be performed on U.S. federally recognized holidays occurring during the normal workweek unless otherwise directed by the Contracting Officer. When a U.S. holiday occurs on a Saturday or a Sunday, the holiday is observed on the preceding Friday or following Monday, respectively.

New Year’s Day ............................................................................. January 1st

M. L. King Memorial Day ............................................................... 3rd Monday in Jan Presidents’ Day .............................................................................. 3rd Monday in February

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

1.5.4. Operating Hours: The Government facility office hours, facility operating hours, and the Contractor support hour requirements often coincide, however, they may differ. Please refer to the following.

1.5.4.1. Government Facility Office Hours: The Government facility office hours are Monday through Friday 7:30am to 5:00pm, except U.S. Holidays identified in paragraph 1.5.3.1 above or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings.

1.5.4.2. Contractor Support Hours: The Contractor shall provide support between the hours of 7:30am to 5:00pm. The Contractor shall maintain an adequate workforce at all times, for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce is essential.

1.5.5. Training Holidays: These are typically combined with regular holiday leave schedules (for example, Christmas half days or day on day off schedules). Training holidays may affect access to military operated facilities. If scheduled work or access to facilities is required, coordination with occupants will be necessary or the work in affected facilities shall be rescheduled after the training holiday. However, announced training holidays or exodus of military personnel may provide the Contractor with an opportunity for unrestricted access to facilities and areas. The Contractor shall take full advantage of such opportunities by planning maintenance or actions that are better accomplished when such areas are vacant.

1.5.6. Place of Performance: The work to be performed under this contract will be performed at Irwin Army Community Hospital, Bldg 650 and Environmental Health Bldg 7665, Fort Riley Kansas.

1.6. Access and General Protection/Security Policy and Procedures: Access to U.S. installations, buildings and controlled areas is limited to personnel who meet security criteria and are authorized to have access to those specific areas. Failure to submit required information/data and obtain required documentation or clearances will be grounds for denying access to U.S. installations, buildings and controlled areas. The Contractor shall ensure that any subcontractors used in performance of this contract comply with these requirements and that all employees, of both the Contractor and any subcontractor utilized by the Contractor, are made aware of and comply with these requirements.

1.6.1. Visitor Access Pass Information: The Contractor technician shall obtain a visitors pass at the Fort Riley Visitors Center before gaining access to the installation. Contractor shall consider possible wait times and arrive in time to perform scheduled service. Address and contact information are listed below.

Fort Riley Visitors Center 885 Henry Drive Fort Riley, Kansas. 66442 Phone Number: 785-239-2982 Website: https://home.army.mil/riley/index.php/about/visitor-info

1.6.2. Vehicle Registration: The Contractor shall ensure its personnel comply with the local installation requirements for vehicle registration and operation on the Installation. Any vehicle operated by Contractor personnel on the military installation must have the minimum liability coverage required by the state in which the performance is located.

https://home.army.mil/riley/index.php/about/visitor-info

1.6.3. Background Checks: Contractor and all associated Sub-contractors’ employees shall comply with applicable installation, facility, and area Commander installation/facility access and local security policies and procedures. The Contractor shall also provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, or the Security Office. Contractor workforce must comply with all personal identity verification requirements 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) change.

1.6.3.1. Contractor personnel and property can be subject to search and seizure upon entering the confines of Fort Riley Army Installation and while on the installation in accordance to AR 190-13 (The Army Physical Security Program). If the Force Protection Condition (FPCON) at any individual facility or installation changes, the Government may require changes in Contractor security matters or processes.

1.6.3.2. The Government is not liable for any costs associated with performance delays due solely to a firm’s failure to comply with Installation Access Control System (IACS) processing requirements.

1.6.4 Individual Termination or Expiration of Employment: The Contractor shall collect the installation access passes the same day employment of an individual has expired or has been terminated and shall return them to the issuing office within one week.

1.6.4.1. Contract Termination or Cancellation: Upon termination or cancellation of this contract, the Contractor shall collect all outstanding installation access passes and return them to the issuing office within one week.

1.6.5. Personnel Security Clearance Requirements: Reserved.

1.6.6. Physical Security: The Contractor shall safeguard all Government equipment, information, and property provided for Contractor use. At the close of each work period, Government facilities, equipment, and materials shall be secured IAW the Army Physical Security Program (AR 190-13).

1.6.7. Operations Security (OPSEC) Requirements: Contractor personnel shall adhere to facility security policies and restrictions. The Contractor shall immediately report suspicious activities to security personnel.

1.7. Key Control: Reserved.

1.8. Post Award Conference/Periodic Progress Meetings: The Contractor shall attend a post award conference convened by the contracting activity or contract administration office before the contract service begins. The Contracting Officer, COR, and other Government personnel, as appropriate, may meet periodically with the Contractor to review the Contractor's performance. At these meetings the Contracting Officer will apprise the Contractor of how the Government views the Contractor's performance and the Contractor shall 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.

1.8.1. The Contractor shall attend, participate in, and furnish input to scheduled and unscheduled meetings, conferences, and briefings that relate to the functions and services herein as required by the Government to provide effective communication and impart necessary information. The Contract Manager or designated representative shall attend meetings as requested by the Government. Meeting attendees shall at times include Contractor managerial, supervisory, and other personnel knowledgeable of the subject matter. Meetings may start or end outside of regular duty hours.

1.9. Contracting Officer’s Representative (COR): Refer to Part 2 of this PWS for the definition of a COR. As determined by the Contracting Officer, a COR will be appointed and identified by letter of designation, a copy of which will be provided to the Contractor by the Contracting Officer. The designation letter 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. The COR monitors all technical aspects of the contract and assists in contract administration. The COR is not authorized to obligate the Government. If the work is not written in the contract, the COR is not authorized to request new work. The COR is authorized to perform the following functions: assure that the Contractor performs the technical requirements of the contract, perform inspections necessary in connection with contract performance, maintain written and oral communications with the Contractor concerning technical aspects of the contract, issue written interpretations of technical requirements, including Government drawings, designs, specifications, monitor Contractor's performance and notifies both the Contracting Officer and Contractor of any deficiencies, coordinate availability of Government property, and coordinate site entry of Contractor personnel.

1.10. Key Personnel: The following personnel are considered key personnel by the Government: The Contractor shall provide a Program/Contract Manager who shall be responsible for the performance of the work.

The name of this person and an Alternate Program/Contract Manager, who shall act for the Contractor when the Program/Contract Manager is absent. The Contract Manager and Alternate Contract Manager shall have full authority to act for the Contractor on all contract matters relating to daily operation of this contract.

1.11. Identification of Contractor Employees: All Contractor personnel attending meetings, answering Government telephones, and working in other situations where their contractor status is not obvious to third parties must identify themselves, to include proper marking of signature blocks in correspondence, to avoid creating an impression in the minds of members of the public that they are Government officials. The Contractor shall ensure that all documents or reports, produced by Contractors are suitably marked as Contractor products or that Contractor participation is appropriately disclosed.

1.11.1. Contractor Identification Badges: Contractor personnel shall be easily identifiable through the display of badges IAW Contractor Identification (AE Reg. 27-715). Contractor personnel performing services at Irwin Army Community Hospital will have an identification badge which shall be displayed on their outer garment at all times.

The badge shall include, at a minimum, the employees’ name, employee’s title, and contractors’ name.

1.13. Hospital Access: Contractor’s service representative shall report to the Clinical Engineering Branch, building 650, Room 0B110 to sign in and receive a temporary badge. The Contractor’s representative shall report back to Clinical Engineering before leaving the facility.

1.14. Other Direct Costs (ODCs): Reserved

1.15. Data Rights: Reserved

1.16. Non-Disclosure Requirements: Reserved

1.17. Protection of Government and Contract Information: Per Public Use Notice of Limitations stated by Defense imagery Management operations Center and contained at www.dimoc.mil/resources/limitations/ , the Contractor shall not cite any information (e.g., contract information, pictures, locations, etc.) obtained through this contract on any digital marketing tools to include its company website.

1.18. Non-Disclosure Statements: Reserved.

1.19. 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 OCI as defined in FAR Subpart

9.5. The Contractor shall notify the Contracting Officer 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 Contracting Officer to avoid or mitigate any such OCI. The Contractor’s OCI Mitigation Plan will be determined to be acceptable solely at the discretion of the Contracting Officer. In the event the Contracting Officer unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, the Contracting Officer 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.

1.20. Phase In /Phase Out Period: Reserved.

http://www.dimoc.mil/resources/limitations/

1.21. Safety: The following provides information pertaining to Safety and Accident Prevention:

1.21.1. The Contractor shall comply with all Federal and State requirements governing safety and health protection on construction sites and other applicable occupational safety codes.

1.22. Environmental Compliance: Reserved.

1.23. Required Training: The following provides information on training requirements.

1.23.1. Anti-Terrorism (AT) Level I Training: All Contractor employees, including subcontractor employees, who are employed under the contract, shall complete AT Level I Training within 30 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 to the Contracting Officer, if a COR is not assigned) within 35 days after completion of this training by all employees and subcontractor personnel. AT Level I awareness training is available at https://jko.jten.mil.

1.23.2. OPSEC Training: Per AR 530-1, the Contractor employees must complete Level 1 OPSEC Awareness training. All Contractor employees, including subcontractors, shall complete Level I OPSEC training within 30 days of employment under this contract and annually thereafter. Verification of the training shall be provided to the COR within 5 after completion of the training. OPSEC Level I training is available at http://www.cdse.edu/catalog/elearning/GS130.html.

1.23.3. 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 days after the contract is awarded and within 30 days after new employees commence contract performance, with the results reported to the COR within 35 days after the contract is awarded and within 35 days after new employees commence contract. Verification of the training shall be provided to the COR within 35 after completion of the training. Training slides can be found on the Army OneSource we site:

http://www.myarmyonesource.com/familyprogramsandservices/iwatchprogram/default.aspx

1.23.4. Information Assurance (IA) Training: Reserved.

1.23.5. Personally Identifiable Information (PII): Reserved.

1.24. Notice to Proceed: Reserved.

PART 2

DEFINITIONS & ACRONYMS

2. Definitions and Acronyms

2.1. Definitions: Although not inclusive of every term used within this PWS, the following provides a list of definitions used throughout this PWS and commonly used in the acquisition field.

Contracting Officer – means a person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings on behalf of the Government. Note: The only individual who can legally bind the Government.

Contracting Officer's Representative (COR) – As defined in DFARS 202.101, means an individual designated and authorized in writing by the Contracting Officer to perform specific technical or administrative functions. DoD Instruction (DoDI) 5000.72, Part II Definitions states the following when defining a COR: “Defined in subpart

202.101 of Reference (f). Any individual delegated responsibilities pursuant to subpart 1.602-2 of Reference (e), regardless of local terminology, must be certified in accordance with this instruction. For example, local https://jko.jten.mil/ http://www.cdse.edu/catalog/elearning/GS130.html http://www.myarmyonesource.com/familyprogramsandservices/iwatchprogram/default.aspx terminology can be COR, Contracting Officer’s technical representative, technical point of contact, technical representative, alternate COR, administrative COR, assistant COR, line-item manager, task order manager, quality assurance personnel, quality assurance evaluator, or COR management.” In addition, Army Regulation 70-13, Chapter 2, paragraph 2-2g, states, in part, the following when providing other surveillance support personnel to assist the COR when needed, “…These other surveillance support personnel may serve as on-site representatives of the COR in performance of actual contract surveillance if they meet all COR requirements and have been appointed by the Contracting Officer as alternate CORs.”

Contractor – means 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.

Contractor-acquired Property - means property acquired, fabricated, or otherwise provided by the Contractor for performing a contract and to which the Government has title.

Day – means, unless otherwise specified, a calendar day.

Defective Service – means a service output that does not meet the standard of performance associated with the Performance Work Statement.

Deliverable – means anything that can be physically delivered but may include non-manufactured things such as meeting minutes or reports.

Government-furnished Property – As reflected in FAR 52.245-1, Government-furnished Property “means property in the possession of, or directly acquired by, the Government and subsequently furnished to the Contractor for performance of a contract. Government-furnished property includes, but is not limited to, spares and property furnished for repair, maintenance, overhaul, or modification. Government-furnished property also includes contractor-acquired property if the contractor-acquired property is a deliverable under a cost contract when accepted by the Government for continued use under the contract

Government Property - means all property owned or leased by the Government.Government property includes both Government-furnished and Contractor-acquired property. Government property includes material, equipment, special tooling, special test equipment, and real property. Government property does not include intellectual property and software.

Property Administrator - means an authorized representative of the Contracting Officer appointed in accordance with agency procedures, responsible for administering the contract requirements and obligations relating to Government property in the possession of a Contractor.

High Level Objective (HLO) – means a key overarching result-based objective for a project necessary to achieve the project’s vision. HLOs are similar to Level 2 in a Work Breakdown Structure. Each HLO may contain several statements to flesh out the areas necessary to meet the objective.

Physical Security – means that part of security concerned with physical measures designed to safeguard personnel; to prevent unauthorized access to equipment, installations, material, and documents; and to safeguard against espionage, sabotage, damage, and theft.

Quality Assurance – (or Government contract quality assurance) means the various functions, including, inspection, performed by the Government to determine whether a Contractor has fulfilled the contract obligations pertaining to quality and quantity.

Quality Assurance Surveillance Plan (QASP) – means the key Government-developed surveillance process document and is applied to Performance-Based Service Contracting (PBSC). The QASP is used for managing Contractor performance assessment by ensuring that systematic quality assurance methods validate that Contractor quality control efforts are timely, effective, and are delivering the results specified in the contract or task order. The QASP directly corresponds to the performance objectives and standards (i.e., quality, quantity, timeliness) specified in the Performance Work Statement (PWS). It provides specific details on how the

Government will survey, observe, test, sample, evaluate, and document Contractor performance results to determine if the Contractor has met the required standards for each objective in the PWS. The QASP, with very few if any exceptions, is an internal to Government document.

Quality Control – means all necessary measures taken by the Contractor to assure that the quality of an end product or service shall meet contract requirements.

Statement – means the specific results-based activities required to satisfy HLOs. A statement contains a result, the context of the statement, and the required action(s). Statements focus on “what” is to be accomplished;

however, they are not prescriptive in describing “how” the outcome is to be achieved. Each HLO may have several statements to flesh out the areas necessary to meet the objective. Statements are similar to Level 3 in a Work Breakdown Structure.

Subcontractor – means one that enters into a contract with a prime Contractor. The Government does not have privity of contract with the subcontractor.

Workday - The number of hours per day the Contractor provides services in accordance with the contract.

Work Week - Monday through Friday, unless otherwise specified.

2.2. Acronyms: Although not inclusive of every term used within this PWS, or that may be included in an acquisition, the following provides a list of acronyms commonly used in the acquisition field.

ACOR Alternate Contracting Officer's Representative AFARS Army Federal Acquisition Regulation Supplement AHA Activity Hazard Analysis AOR Area of Responsibility AR Army Regulation AT Anti-terrorism ATCTS Army Training Certification Tracking System CAC Common Access Card CCE Contracting Center of Excellence CFR Code of Federal Regulations CONUS Continental United States (excludes Alaska and Hawaii) COR Contracting Officer’s Representative COTS Commercial-Off-the-Shelf DA Department of the Army DD250 Department of Defense Form 250 (Receiving Report) DD254 Department of Defense Contract Security Requirement List DFARS Defense Federal Acquisition Regulation Supplement DMDC Defense Manpower Data Center DoD Department of Defense FAR Federal Acquisition Regulation FRG Federal Republic of Germany GFP Government Furnished Property HIPAA Health Insurance Portability and Accountability Act of 1996 IA Information Awareness IAC Installation Access Control IACO Installation Access Control Office ID Identification IGCE Independent Government Cost Estimate IT Information Technology JTR Joint Travel Regulation JPAS Joint Personnel Adjudication System KO Contracting Officer OCI Organizational Conflict of Interest

OCONUS Outside Continental United States (includes Alaska and Hawaii) ODC Other Direct Costs OPSEC Operations Security PA Property Administrator PII Personally Identifiable Information PIPO Phase In/Phase Out POC Point of Contact PRS Performance Requirements Summary PWS Performance Work Statement QA Quality Assurance QAP Quality Assurance Program QASP Quality Assurance Surveillance Plan QC Quality Control QCP Quality Control Program RA Requiring Activity RCO Regional Contracting Office SIGE Safety and Health Protection Plan TE Technical Exhibit USAG United States Army Garrison UOM Unit of Measure

PART 3

GOVERNMENT PROPERTY (GP) AND SERVICES

3. Government Property and Services

3.1. Perosnnel: The Government will make available the following Government Points of Contact for questions and to set up service appointments.

COR: Michelle Trussell Alteranate COR: Michael Cossey Officer in Charge (OIC): WO1 Ean Butler Non-Commissioned Officer in Charge (NCOIC): SFC Anthony Boheler

3.2. Facilities: All rooms where the equipment is located will be made available to the Contractor.

3.3. Utilities: Reserved.

3.4. Equipment: The Government will grant access to the equipment listed in the table below, so that the Contractor can perform the services required under this contract.

Equipment Listing

Manufacturer Nomenclature Serial Number Location

Labconco Laboratory Hood, Chemical Fume, Ductless 150407326C

Operative Service Room:

2B199

Labconco Cabinet, Biological Safety, Class II 121168107

Main Pharmacy Room:

1A139/1H139

Labconco Cabinet, Biological Safety, Class II 121168336C

Clinical Pathology Room:

2A159/2H301

Labconco Cabinet, Biological Safety, Class II 121168329C

Clinical Pathology Room:

2A159/2H314

Labconco Laboratory Hood, Chemical Fume 140491151D

Clinical Pathology Room# 2A157/2H301

Labconco Laboratory Hood, Chemical Fume 140187192C

Main Pharmacy Room:

1A139/1H139

Labconco Cabinet Biological Safety, Class II 140998216D

Environmental Health (Caldwell) BLDG 7665

Sakura Finetek Autopsy/Grossing Hood 05431 Clinical Pathology Room:

2A157/2H301

Nuaire Glove Box, Isolation/Containment 20745108221

Main Pharmacy Room:

1A139/1H135

3.5. Testing Failure: The Government is responsible for correcting the issues found during certification testing.

The requalification test cost will be the responsibility of the Government.

3.6. Materials: Reserved.

3.7. Training: Reserved.

3.8. Common Access Cards (CAC): Reserved.

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4. Contractor Furnished Property and Services

4.1. General: 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. For example:

a) Contractor service technicians that are certified and licensed to perform testing and certification of the equipment listed in the PWS.

b) Controlling Environment Testing Association (CETA) certified/licensed Contractor service technician able to perform testing and certification of the clean rooms, and buffers.

c) Tools

d) Contractor technician shall ensure the testing equipment shall meet calibration requirements in accordance with manufacturer recommendations.

4.1.1. The performance of all services shall meet or exceed the specifications of the OEM. During the contracting timeframe, 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, and CETA. Contactor will be knowledgeable of any changes within the USP 797, USP 800, NSF/ANSI 49, OSHA, NIH/CDC, and 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 be based on the manufacturer’s guidelines for the BSC or the engineering design guidelines for the compounding rooms.

4.2. Secret Facility Clearance: Reserved.

4.3. Materials: Reserved.

4.4. Vehicles and Equipment: Reserved.

4.5. Background Checks): Reserved.

PART 5

SPECIFIC TASKS

5.1. Basic Services: The Contractor shall perform inspection and testing of the equipment and clean rooms referenced in PWS section 3 para. 3.4.

5.2. Tasks: The Contractor shall perform testing of the fume hoods, BSC’s, and clean rooms to include testing of the clean room HEPA filtration system. Testing and certification shall be completed one week prior to the expiration date of the prior certification.

5.2.1. Fume hood, biological safety cabinet, compounding isolator, and grossing hood 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 air and surface 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).

5.2.2. 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 counting (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, Contractor shall provide certification documentation to the Government Point of Contact (GPOC) provided at the time of service.

5.5. Irwin Army Community Hospital Included Services:

5.5.1. 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 surface sampling per USP <797> Room viable/nonviable air sampling per USP <797> Temperature testing Humidity testing.

Terminal HEPA filter volume testing.

Terminal HEPA integrity testing Report Generation Initial reports set up Service call truck charge

5.5.2. Laboratory:

Biological safety cabinet certification.

Fume hood certification.

Grossing hood certification Service call truck charge

5.5.3. Caldwell Clinic (Environmental Services)

Balance enclosure certification w/ exhaust HEPA Fume hood certification.

Service call truck charge.

5.6. Service Report: The service report shall be received no more than 48 hours after 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. The report will include a statement of compliance or non-compliance regarding the requirements and guidelines outlined in the PWS.

Nome, 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 standards were 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 (SOP’s) supplied by the client. 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 hard copy of the current calibration documentation for each piece of equipment.

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.

5.6.1. Lab results of samples taken at the time of service are not required to be provided within the 48-hour period. Results will be made available to the Government no more than two weeks after samples are sent for identification.

5.7. Forms: After performing on-site inspection, testing, and certification services, the Government technician or Contractor will affix and/or update DDForm 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.

5.8. 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.

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

5.10. Invoicing and Payment: The Contractor shall submit itemized invoices no more than 30 days after service completion. Invoice shall be submitted to on Procurement Integrated Enterprise Environment (PIEE) subsection Invoicing, Receipt, Acceptance, and Property Transfer (iRAPT). Information regarding invoicing is available on Procurement Integrated enterprise Environment (PIEE) at https://piee.eb.mil. Subsection Invoicing, Receipt, Acceptance, and Property Transfer (iRAPT). Payment will be made by the Defense Finance and Accounting Service (DFAS), PART 6

APPLICABLE PUBLICATIONS

6. Applicable Publications (Current Editions): The following publications, manuals, regulations, etc. are mentioned in this PWS and are listed below.

6.1.1 Department of Defense Contract Security Classification Specification (DD Form 254)

6.1.2 Department of Defense Security Agreement (DD Form 441)

6.1.3 National Industrial Security Program Operating Manual (DoD 5220.22-M)

6.1.4 Installation Access Control (AE Reg 190-16)

6.1.5 The Army Physical Security Program (AR 190-13)

6.1.6 Contractor Identification (AE Reg 27-715)

6.1.7 U.S. Army Corps of Engineers Safety and Health Requirements Manual (EM 385-1-1)

6.1.8 Information Assurance Workforce Improvement Program (DoD 8570-M)

6.1.9 Information Assurance Training Certification and Workforce Management Directive (DoDD 8570.01)

6.1.10 Information Assurance (AR 25-2)

6.1.11 Electromagnetic Compatibility Directive (2004/108/EC)

6.1.12 Policies and Procedures for Property Accountability (AR 735-5)

6.1.13 Pharmaceutical Compounding-Sterile Preparations (USP 797)

6.1.14 Hazardous Drugs-Handling in Healthcare Settings (USP 800)

6.1.15 Biosafety Cabinetry: Design, Construction. Performance, and Field Certification (NSF/ANSI 49)

6.1.16 Maintenance Management Procedures for Medical Equipment (TB 38-750-2) https://piee.eb.mil/

PART 7

ATTACHMENT AND TECHNICAL EXHIBIT LISTING

7. Attachment and Technical Exhibit List

7.1 Technical Exhibit A – Performance Requirements Summary

TECHNICAL EXHIBIT A

Performance Requirements Summary (PRS)

PERFORMANCE OBJECTIVE STANDARD PERFORMANCE

THRESHOLD

ACCEPTABLE

QUALITY LEVELS

(AQLs)

METHOD OF

SURVEILLANCE

PRS#1 - PWS para (1.1 ) The contractor shall provide on-site inspection, testing and certification of fume hoods, BSC’s, and testing of the clean/compounding rooms.

Services will be performed on a semi-annual basis.

100% 100% Inspection

PRS#2 - PWS para (1.6) Access to U.S. installations, buildings and controlled areas is limited to personnel who meet security criteria and are authorized to have access to those specific areas.

Failure to submit required information/data and obtain required documentation or clearances will be grounds for denying access to U.S.

installations, buildings and controlled areas.

100% 100% Inspection

PRS#3 - PWS para (1.6.1) The Contractor technician shall obtain a visitors pass at the Fort Riley Visitors Center

The contractor shall go to the address listed in paragraph 1.6.1 to get the visitors’ pass.

100% 100% Inspection

PRS#4 - PWS para ( 1.6.2) The Contractor shall ensure its personnel comply with the local installation requirements for vehicle registration and operation on the Installation.

Any vehicle operated by Contract personnel on the military installation must have the minimum liability coverage required by the state in which the performance is located.

100% 100% Inspetion

PRS#5 -PWS para (1.8.1) The Contractor shall attend, participate in, and furnish input to scheduled and unscheduled meetings, conferences, and briefings that relate to the functions and services as required by the Government to provide effective communication and impart necessary information.

Meeting attendees shall at times include Contractor managerial, supervisory, and other personnel knowledgeable of the subject matter. Meetings may start or end outside of regular duty hours.

PRS#6 – PWS para (4.1.1) 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, and CETA

Contactor will be knowledgeable of any changes within the guidelines and able to certify compound rooms and BSC according to those guidelines.

100% 100% Inspection

PRS#7 – PWS para (5.2) Testing and certification shall be completed one

The Contractor shall perform testing of the fume hoods, BSC’s, and clean rooms to include testing of the clean room HEPA filtration system.

week prior to the expiration date of the prior certification.

PRS#8 – PWS para (5.2.1) Fume hood, biological safety cabinet, compounding isolator, and grossing hood testing shall include the items listed in 5.2.1.

Testing shall include Inflow velocity measurements, Downflow velocity measurements, HEPA filter integrity testing, Smoke pattern testing, Site installation testing and alarm calibration, Viable air and surface sampling

100% 100% Inspection

PRS#9 – PWS para (5.2.2) Compounding room testing shall include the items listed in the 5.2.2 of the PWS.

Testing shall include airflow test-turbulent airflow, unidirectional airflow, room pressurization, airflow displacement, HEPA filter installation leak test, airborne non-viable particle counting (surface and air)

PRS#10 – PWS para (5.3) Deficiencies noted shall be reported immediately to Clinical Engineering 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.

100% 100% Inspection

PRS#11 – PWS para (5.5.6) Contractor shall provide service report.

Service report shall be provided no more than 48 hours after service completion.

95% Periodic Inspection

PRS#12 – PWS para (5.10) The Contractor shall submit itemized invoices.

Invoices shall be submitted after the completion of services.

95% Periodic Inspection