Attachment A - Lab Flow Hood Maintenance PWS v2.docx

PERFORMANCE WORK STATEMENT (PWS)

Laminar Flow Hoods and Cabinet Equipment Test and Certification Biomedical Engineering Services (BES) Part 1 General Information

1. GENERAL: This is a non-personnel services contract to provide testing and re-certifications for 130 Laboratory Biological Safety Cabinets and Laminar Flow Hoods. The Government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the contractor who, in turn is responsible to the Government.

1.1 Description of Services/Introduction: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform testing and re-certifications for 130 Laboratory Biological Safety Cabinets and Laminar Flow Hoods as defined in this Performance Work Statement except for those items specified as government furnished property and services. The contractor shall perform to the standards in this contract. Brooke Army Medical Center (BAMC), Logistics Division is responsible for this contract and on-site services will be performed throughout BAMC and at the DoD Food Analysis & Diagnostic Laboratory (FADL) at FT. Sam Houston.

1.2 Background: There are 130 Laboratory Biological Safety Cabinets and Laminar Flow Hoods located at BAMC and the FADL. They are required to be tested and re-certified on an annual and semi-annual basis which will be based on a schedule provided by Biomedical Engineering Services.

1.3 Objectives: The purpose is to provide the best maintenance for medical equipment in accordance with the manufacturer's maintenance manuals, specification, and quality control policies and procedures governed by the BAMC Biomedical Engineering Services (BES) and the respective using activity. Information concerning the systems to be serviced is furnished from the best available sources.

Scope:

1.3.1 Scheduled Services (Re-Certifications): Scheduled services include actions relating to the preventive maintenance, testing, operation verification and certification of the system and its components. The contractor shall perform annual and semi-annual testing and re-certifications according to the standards outline in Part 1.3.

1.3.2 Unscheduled Services: Reserved.

1.4 Period of Performance: The period of performance shall be for one (1) Base Year of 12 months and four (4) 12-months option years. The Period of Performance reads as follows:

Base Year: 1 Oct 25 – 30 Sep 26 Option Year 1: 1 Oct 26 – 30 Sep 27 Option Year 2: 1 Oct 27 – 30 Sep 28 Option Year 3: 1 Oct 28 – 30 Sep 29 Option Year 4: 1 Oct 29 – 30 Sep 30 FAR 52.217-8: 1 Oct 30 – 31 Mar 31

1.5 General Information

1.5.1 Quality Assurance: The government shall evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan. 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 minimum acceptable defect rate(s).

1.6.3 Recognized Holidays: The contractor is not required to perform services on the holidays listed below. But if any of the holidays listed is not a holiday that the contractor considers a holiday, services can be performed without any added costs only with the Contracting Officer’s Representative (COR) authorization.

1.6.4 Hours of Operation: BAMC and FADL normal operating hours are Monday thru Friday, 0730hrs to 1630hrs, except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. Any services outside normal operating hours must be coordinated with the COR.

1.6.5 Place of Performance: The work to be performed under this contract will be performed at BAMC and the FADL.

1.6.6 Type of Contract: The government will award a Firm Fixed Price contract.

1.6.7 Security Requirements: Contractor personnel performing work under this contract must have either an access base pass or a DBIBS ID card submitted by the COR, or Subject Matter Expert (SME) and approved by 502nd Security Forces Squadron, Fort Sam Houston, TX at time of the proposal submission, and must maintain the level of security required for the life of the contract.

1.6.7.1 PHYSICAL Security: The contractor shall be responsible for safeguarding 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.

1.6.7.2 Key Control. NA

1.6.7.2.1. NA

1.6.7.2.2. NA

1.6.7.3 NA

1.6.8 Special Qualifications: The field service technician shall be authorized, certified, and trained in the testing and re-certification of Laboratory Biological Safety Cabinets and Laminar Flow Hoods. Additionally, the service technician shall have a minimum of two years’ experience within the last 36 months, to be provided to the COR upon request.

1.6.9 Post Award Conference/Periodic Progress Meetings: The Contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation Subpart 42.5. 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 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.

1.6.10 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: 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 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.

Ms. Kathy Clayton, Contracting Officer’s Representative, BAMC Phone# 210-539-1164, Email: kathy.g.clayton.civ@mail.mil

Mr. Gerd Schwalbe, Electronic Technician, BAMC, SME Phone# 210-539-9843-4962, Email: gerd.k.schwalbe.civ@mail.mil

1.6.11 Data Rights: The Government has unlimited rights to all documents/material produced under this contract. All documents and materials, to include the source codes of any software, produced under this contract shall be Government owned and are the property of the Government with all rights and privileges of ownership/copyright belonging exclusively to the Government. These documents and materials may not be used or sold by the contractor without written permission from the Contracting Officer. All materials supplied to the Government shall be the sole property of the Government and may not be used for any other purpose. This right does not abrogate any other Government rights.

1.6.12 Organizational Conflict of Interest: 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 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 mitigation plan will be determined to be acceptable solely at the discretion of the Contracting Officer and in the event the Contracting Officer unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, the Contracting Officer may effect 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.

PART 2 DEFINITIONS & ACRONYMS

2. DEFINITIONS AND ACRONYMS:

2.1. DEFINITIONS:

2.1.1. CONTRACTOR. A supplier or vendor awarded a contract to provide specific supplies or service to the government. The term used in this contract refers to the prime.

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

2.1.3. CONTRACTING OFFICER'S REPRESENTATIVE (COR). An employee of the U.S. Government appointed by the contracting officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the Contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

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

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

2.1.9. QUALITY ASSURANCE Surveillance Plan (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

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

2.1.11. SUBCONTRACTOR. One that enters into a contract with a prime contractor. The Government does not have privity of contract with the subcontractor.

2.1.12. WORK DAY. The number of hours per day the Contractor provides services in accordance with the contract.

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

2.2. ACRONYMS:

PART 3

GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

3. GOVERNMENT FURNISHED ITEMS AND SERVICES:

3.1. Services: The Government may provide a BES technician to observe a quality assurance test, in accordance with the QASP, prior to the departure of the contractor’s service technician.

3.2 Facilities: The Government will provide access to the devices and systems requiring services.

3.3 Utilities: The Government will provide all necessary utilities, including power to the devices, required to perform the service. The Contractor shall instruct employees in utilities conservation practices. The contractor shall be responsible for operating under conditions that preclude the waste of utilities, which include turning off the water faucets or valves after using the required amount to accomplish cleaning vehicles and equipment.

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4. CONTRACTOR FURNISHED ITEMS AND RESPONSIBILITIES:

4.1 General: The Contractor shall furnish all supplies, equipment, facilities and services required to perform work under this contract that are not listed under Section 3 of this PWS.

4.2. Materials. The Contractor shall provide parts and materials required to perform the services outlined in this PWS.

4.4. Equipment. The Contractor shall provide equipment required to perform services and quality assurance test outlined in this PWS.

PART 5 SPECIFIC TASKS

5. Specific Tasks:

5.1. Basic Services. The contractor shall provide testing and re-certification of Laboratory Biological Safety Cabinets and Laminar Flow Hoods.

5.2. Scheduled Services. Scheduled services are those actions relating to the preventive maintenance, testing, operation verification and certification of the system and its components. The contractor shall perform annual and semi-annual testing and re-certification of 130 Laboratory Biological Safety Cabinets and Laminar Flow Hoods which will be based on a schedule provided by Biomedical Engineering Services. The contractor shall perform all testing and re-certifications according to manufacturer specifications and the published standards outline in paragraph 1.3. The contractor will adhere to the following when performing scheduled services:

a. Contractor must coordinate expected arrival date and time with COR.

b. All scheduled services (Testing and Re-certification) must be completed by the 15th business day of the month.

c. Update DD Form 2163, Medical Equipment Verification and Certification sticker on the medical device as needed. The DD Forms are available in the Biomedical Engineering Services upon request. If field service technician has any question contact COR.

d. Prepare and provide a maintenance service report for all services rendered. Service reports must be received by the COR NLT 72 hours from completion of work.

5.3. Unscheduled Service. Reserved.

5.4. CONTRACTOR MANAGEMENT REPORTING (CMR): NA, this is now part of SAM.gov registration.

PART 6 APPLICABLE PUBLICATIONS

6. APPLICABLE PUBLICATIONS (CURRENT EDITIONS)

6.1. The Contractor must abide by all applicable regulations, publications, manuals, and local policies and procedures.

6.1 The contractor shall perform all testing and re-certifications according to manufacturer specifications and the following published standards:

The knowledge of the field service technician shall not relieve the Contractor of the requirement for visiting the location of the systems listed and to be thoroughly familiarized with all components associated with the item(s) and conditions under which the work is to be performed.

AR 385-10, “The Army Safety Program,” 24 February 2017 AR 40-61, “Medical Logistics Policies,” 28 January 2005 AR 40-2, “Composition, Mission, and Functions of the Army Medical Department,”24 May 2019 AR 1130-51, “Security of Unclassified Army Resources (Sensitive and Nonsensitive),” 27 June 2019 AR 710-2, “Supply Policy Below the National Level,” 28 March 2008 AR 735-5, “Property Accountability Policies,” 9 November 2016 AR 750-43, “Army Test, Measurement, and Diagnostic Equipment,” 24 January 2014 DHA AI 6430.11, “Healthcare Technology Management Biomedical Equipment Program,” 14 October 2021 DoD 8510.01, “Risk Management Framework for DoD Information Technology,”12 March 2014 SB 8-75-11, “Army Medical Department Supply Information,” 20 November 2018 TB 38-750-2, “Maintenance Management Procedures for Medical Equipment,” 12 April 1987 W81K0024P0155 TB 43-180, “Calibration and Repair Requirements for the Maintenance of Army Materiel,” 1 May 2022 TB MED 750-1, “Operating Guide for Medical Equipment Maintenance,” 1 April 1998 NFPA 99, “Health Care Facilities Code,” 2021 Edition

PART 7 ATTACHMENT/TECHNICAL EXHIBIT LISTING

7. Attachment/Technical Exhibit List:

7.1. Attachment 1/Technical Exhibit 1 – Performance Requirements Summary

7.2. Attachment 2/Technical Exhibit 2 – Deliverables Schedule

7.3. Attachment 3 – Equipment List

7.1 TECHNICAL EXHIBIT 1

Performance Requirements Summary The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. 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”) Method of Surveillance

PRS # 1.

The contractor shall provide fully certified contractor personnel.

PRS # 2

The contractor shall provide a service report within 72 hours.

Inspection.

PRS # 3

The contractor shall provide scheduled services by the 15th business day of the scheduled month.

Inspection.

7.2 TECHNICAL EXHIBIT 2 DELIVERABLES SCHEDULE

Gerd.k.schwalbe.civ@mail.mil Hard Copy address:

Brooke Army Medical Center 3551 Roger Brooke Drive, Fort Sam Houston, TX 78234 ATTN: Biomedical Engineering, Room TC-L28

are required.

Gerd.k.schwalbe.civ@mail.mil

7.3 ATTACHMENT EQUIPMENT LIST