PWS_AUTOCLAVES_GLASSWASHER_2025.docx

PERFORMANCE WORK STATEMENT

Preventative Maintenance and Repair of Autoclaves and Glassware Washers DEVCOM Chemical Biological Center (CBC), BioTesting Division (BTD)

General Information

1. General. BioTesting Division (BTD) at Dugway Proving Ground (DPG), part of DEVCOM Chemical Biological Center (CBC), requires procurement of a service contract to provide Preventative Maintenance (PM) and Repair of BTD Autoclaves and Glassware Washers. 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.a. 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 PM and Repair of autoclaves and glassware washers at BTD as defined in this Performance Work Statement (PWS).

1.b. Background. The proposed service contract will assure consistent and calibrated operation of eleven (11) autoclaves and one (1) laboratory glassware washer. BTD is located at Bldg. 2029, DPG. The contract will enable BTD to clean and sterilize test materials and equipment for developmental and operational testing of biological defense systems.

1.c. T&E requirements. More strictly, BTD must perform its testing with high reliability in accordance with (IAW) Test and Evaluation (T&E) requirements of the Department of Defense (DoD) Chemical Biological Defense Program (CBDP). This capability provides the clean and sterilized materials needed to effectively evaluate the performance of referee biological detectors and identification equipment and/or systems under test (SUT) to support national and DoD priorities to counter biological threats and attacks.

1.d. Scope in brief. Contractor shall provide the following for 11 autoclaves and 1 glassware washer: A) monthly PM; B) monthly autoclave biological validation; C) quarterly autoclave calibration and certification; D) unlimited 24-hr emergency repair, and E) annual rebuild of each BTD autoclave (approximately one per month). All service encounters will include a bio-validation assay (see section 2b and section 6) run during a full run check cycle before the autoclave may be put back into service. Monthly service reports, organized by serial number (see equipment list, section 5), will be timely submitted to the COR.

Additionally, in Option Years 1, 2 and 3, BTD shall have the opportunity to fund the complete recovery and rebuild of three inactive pass-through autoclaves (one per year) located in Bldg. 2028. These autoclaves have not been run for many years.

1.e. Period of performance (POP): The proposed contract POP shall be for one (1) Base Year of 6 months, four (4) option years of 12 months, and 1 6 month extension, if needed. The POP reads as follows:

2 Performance requirements

2.a. Preventative maintenance. Monthly on-site PM is performed on all BTD autoclave and glassware washer systems (see equipment list, section 5) to enable operation at peak performance IAW manufacturers’ specifications. PM services typically include inspection, leak testing, lubrication, necessary adjustment of door mechanisms, and preventative replacement of door gaskets. A cycle progression inspection is also performed to note proper actuation of valves. All encounters will conclude with a bio-validation assay on a full run check cycle before the autoclave may be put back into service.

2.b. Monthly biological validation. As per DoD Manual Number 6055.18-M (May 11, 2010) Safety Standards for Microbiological and Biomedical Laboratories, monthly biological performance validation of all BTD autoclaves (see equipment list, section 5) will be performed using a suitable commercial biological indicator kit that is acceptable to the COR (see specific bio-validation guidance, section 6). The assay will be performed using a full run check cycle. These kits test the ability of an autoclave to kill 100% of the challenge Geobacillus stearothermophilus spores packaged into the assay. If the autoclave cannot achieve this result, it cannot be put back into service.

2.c. Quarterly calibration. Quarterly calibration is done with National Institute of Standards and Technology (NIST) traceable heat and pressure probes on each BTD autoclave (see equipment list, section 5) while executing a full run check cycle. This is done to ensure that all autoclave and glassware washer units can achieve defined temperature/pressure targets to match original manufacturer's specifications. Contractor will develop a schedule with COR to ensure that all systems are calibrated every 90 days. Upon completion of the calibration, the autoclave must pass a bio-validation assay on a full run check cycle before the autoclave may be put back into service. Performance certificates shall be affixed to the front of each unit.

2.d. Emergency repair. By request, contractor shall provide unlimited on-site assessments and repair visits. Response time from time of call (BTD to contractor) shall be within 24 hours, or time of email within 48 hours. If a repair is found to be necessary, parts are repaired or replaced. After assessment or repair is complete, each system must operate IAW manufacturer’s specifications as demonstrated by running a bio-validation assay on a full run check cycle.

2.e. Annual autoclave rebuild. “Rebuild” in this context means that all autoclave wearable components are inspected or replaced annually (approximately one autoclave per month). This includes inspection or replacement of all check valves, steam traps, door switches, pressure switches, temperature switches, proximity switches, pin traps, and actuating valves, whether solenoid, pneumatic, or pilot, plus annual cleaning/descaling of sterilizer chambers. As a result, the autoclaves are maintained for peak laboratory performance and safety. All encounters will include a passing bio-validation on a full run check cycle before the autoclave may be put back into service.

2.f. Rebuild and recovery of inactive autoclaves. BTD may, in Option Years 1, 2 and/or 3, choose to fund the complete rebuild and recovery of three inactive pass-through autoclaves (one per year) located in Bldg. 2028. These autoclaves have not been run for many years and their rebuild and recovery will be a major technical task requiring many weeks of labor and new replacement parts. After each repair, the autoclave must pass a bio-validation assay on a full run check cycle before it can be certified and added back into service.

2.g. Service Reports. Service reports, organized by instrument serial number, will be submitted monthly to the COR to include all service encounters, all quarterly calibrations, all bio-validations (spore viabilities), and all emergency service calls. Performance checkoffs of PM, bio-validations and quarterly calibrations will be attached to the front of each unit for user awareness.

3. General Requirements.

3.a. Non-Personal Services. The government shall neither supervise contractor employees nor control the method by which the contractor performs the required tasks. Under no circumstances shall the government assign tasks to, or prepare work schedules for, individual contractor employees. It shall be the responsibility of the contractor to manage its employees and guard against any actions that give the perception of providing personal services. If the contractor believes that any actions constitute, or are perceived to constitute personal services, it shall be the contractor's responsibility to notify the contracting officer (KO) immediately.

3.b. Business Relations. The contractor shall successfully integrate and coordinate all activity needed to execute the requirement. The contractor shall manage the timeliness, completeness, and quality of problem identification. The contractor shall provide corrective action plans, proposal submittals, timely identification of issues, and effective management of subcontractors. The contractor shall endeavor to be responsive to BTD laboratory personnel and seek to ensure customer satisfaction and professional and ethical behavior of all contractor personnel.

3.c. Contract Management. The contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the requirement. The contractor must maintain continuity between the support operations at BTD and contractor's corporate offices.

3.d. Contract Administration. The contractor shall establish processes and assign appropriate resources to effectively administer the requirement. The contractor shall have a single designated point of contact (POC) between the Government and Contractor personnel assigned to support contract tasks. The contractor shall assign work effort and maintain proper and accurate time keeping records of personnel assigned to work on the requirement.

3.e. Personnel Administration. The contractor shall provide the following management and support as required. The contractor shall provide for employees during designated government non-workdays or other periods where the contractor shall maintain currency of their employees by providing initial and refresher training as required to meet PWS requirements. The contractor shall make necessary travel arrangements for employees and provide necessary infrastructure to support contract tasks. The contractor shall provide administrative support to employees in a timely fashion (time keeping, leave processing, pay, emergency needs).

3.f. Subcontract Management. Contractor shall be responsible for any subcontract management necessary to integrate work performed on this requirement and shall be responsible and accountable for subcontractor performance. Contractors may add subcontractors to their team upon notification of COR or KO.

3.g. Location and Hours of Work. Accomplishment of the requirements contained in this PWS requires work at BTD, DPG, and any of its additional facilities. Normal workdays are Monday through Thursday, ten (10) hours per day, forty (40) hours per week, 0700 to 1730, except US federal holidays or when the government facility is closed due to inclement weather, administrative closings, lapses in federal appropriations or security conditions due to local or national emergencies. The COR or designated technical contact are expected to be available during core hours.

3.h. Contractor Personnel, Disciplines, and Specialties. The contractor shall accomplish the assigned work by employing and utilizing qualified personnel with appropriate combinations of education, training, and experience. The contractor shall provide the necessary resources and infrastructure to manage, perform, and administer the contract. The contractor must maintain an adequate workforce for the performance of all tasks defined within this PWS when the government facility is not closed for the above reasons. When hiring personnel, contractor shall keep in mind that stability and continuity of the workforce is essential.

3.i. Recognized Holidays. The contractor is not required to perform services on federal holidays.

New Year’s Day Martin Luther King Jr. Birthday President’s Day Memorial Day Junteenth Independence Day Labor Day Columbus Day Veteran’s Day Thanksgiving Day Christmas Day

3.j. 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.

Definitions and Acronyms

4 Definitions and Acronyms:

4.a. 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.

4.b. Contracting Officer (KO). 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 KO is the only individual who can legally bind the government.

4.c. Contracting Officer's Representitive (COR). An employee of the US government appointed by the KO to assist in administering the contract. The COR will be identified by separate letter, a copy of which is sent to the contractor, stating the scope of the COR’s authority and limitations. This individual provides technical direction to the contractor so 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.

The COR also performs inspections as necessary to assess contract performance, maintains written and oral communications with the contractor and the KO concerning technical aspects of the contract, issues written interpretations of technical requirements, including government drawings, designs, specifications, monitors contractor's performance and notifies both the KO and contractor of any deficiencies; coordinates availability of government furnished property, and provides site entry to contractor personnel.

4.d. Defective Service. A service output that does not meet the standard of performance associated with the PWS.

4.e. Deliverable. Anything that can be physically delivered but may include non-manufactured things such as monthly service reports.

4.f. Quality Assurance. The government procedures to verify that services being performed by the contractor are performed according to acceptable standards.

4.g. Quality Assurance Surveillance Plan (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

4.h. Quality Control. All necessary measures taken by the contractor to assure that the quality of an end product or service shall meet contract requirements.

4.i. Subcontractor. One that enters into a contract with the prime contractor. The government does not have privity of said contract with the subcontractor.

4.j. Acronyms:

5. Autoclave and Dishwasher EQUIPMENT LIST (BioTesting Division)

Room 1413

Room 1413

1501, 1601

1501, 1601,

6. Bio-Validation Guidance:

6.1. DoD Guidance. Monthly biological validation is required of all DoD laboratory autoclaves, including all BTD autoclaves. This is mandated by DoD Manual 6055.18-M (May 11, 2010) Safety Standards for Microbiological and Biomedical Laboratories. Adherence to this guidance demands all autoclaves to function as designed and provide the appropriate level of sterilization and/or decontamination of test materials. Autoclaves neutralize infectious substances and sterilize contaminated equipment before washing, re-use, storage or disposal.

Biological validation employs a bacterial indicator, the spores of Geobacillus stearothermophilus. These spores are the most thermal-hardy life forms found on earth, i.e., they are the most difficult biological entities to kill with high heat at high pressure. If an autoclave can kill 100% of the indicator spores tested, then it is defined as functioning at operational efficiency. A passing bio-validation is the result of 100% spore kill; a failed bio-validation is a result that has detected the presence of even 1 viable spore in the challenge sample.

Biological Validation of Autoclaves. Bio-validation is to be done every month or after any maintenance has been performed on BTD autoclaves. Autoclaves will not be used until the validation incubation period or other activity measure results in an indication of negative spore growth.

Bio-validation Test Kits. Scientifically reputable and commercially available biological autoclave performance test kits will be used. The commercial supplier and type of kit to be employed by the contractor must be approved by the COR.

A total of four (4) assays will be used per bio-validation test. The first assay is a positive control (not autoclaved; it will demonstrate growth of the test spores, because they are not subjected to sterilization). The three remaining Test Packs will be equally distributed throughout the autoclave chamber.

One assay is placed in the back of the chamber and a second will be placed at the front, with a third Test Pack in-between. BTD has a number of very large pass-through autoclaves. In this case, it is necessary to arrange the three Test Packs in a balanced manner. The bottom of the chamber directly over the drain is the coolest spot during any autoclave run. Therefore, if a test pack is placed in this position and passes the bio validation test (= no growth), then all locations in the autoclave will necessarily pass the test also, because hot air rises.

Documentation of the bio-validation. All validations will be documented by the contractor on a paper sheet posted at each autoclave to include whether or not the bio validation passed (100% spore kill) or failed (1 or more viable spores indicates failure). Bio-validation results must be captured as well in the monthly service reports to be submitted to the COR. Once validated, the autoclaves can resume normal operations by laboratory staff.