DRAFT_PWS Autoclaves 2020.01.23.docx

Performance Work Statement (PWS)

CCDC Chemical Biological Center (CBC), Bio Testing Division (BTD) Preventative Maintenance and Repair of Autoclaves and Glassware Washers

Vision: To procure a service contract that assures consistent and calibrated operation of twenty (20) autoclaves and one (1) laboratory glassware washer for BTD, located at Bldg. 2029, Dugway Proving Ground, UT 84022-5004.

1. Introduction. BTD requires the ability to clean and sterilize test materials and test equipment for developmental and operational testing of biological defense systems. More strictly, BTD has a requirement to sustain its autoclaves and glassware washer. Several manufacturers and service companies employ technicians who can meet this requirement and provide routine maintenance, repair and performance validation of these critical systems.

1.1 Mission. The ability to clean and sterilize equipment and biological test materials with high reliability in accordance with (IAW) the requirements of the biological defense Testing and Evaluation program. This capability provides the clean materials and sterilization needed to effectively evaluate the performance of referee biological detection and identification equipment and/or systems under test to support national and DoD priorities to counter biological threats and attacks.

1.1.1 Applicable Documents.

1.1.1.1 DoD 6055_18-M Safety Standards for Microbiological and Biomedical Laboratories 11 May 2010

1.1.1.2 Internal BTD SOP

1.1.1.3 CBC-BTD SOP RNB-485

1.2 Scope. To procure a commercial service contract in which the Contractor shall provide the following for 20 autoclaves and 1 glassware washer: quarterly preventative maintenance (PM), quarterly certification, unlimited 24-hr emergency repairs, and monthly biological validations (autoclaves only). All validation and certification encounters will include a full run check cycle. All encounters will be followed up with a service report submitted to the COR IAW exhibit line item number (ELIN) A001.

1.2.1. Quarterly PM on all autoclaves and one glassware washer. To enable operation at peak performance IAW manufacturers’ specifications. Upon completion of PM, service reports, sorted by serial number, shall be submitted to COR IAW ELIN A001.

1.2.2. Quarterly On-Site Calibrations and Certifications. To validate operation using full run cycles on each unit item (see equipment list, section 4) to manufacturer's specifications. Upon completion of certification, performance certificates, sorted by serial number, shall be submitted to COR and copies affixed to the front of each unit IAW ELIN A002.

1.2.3. Unlimited On-Site Assessments and Repair Visits. Response time from time-of- call (BTD to contractor) shall be within 24 hours. After assessment/repair service is complete, each system must operate IAW manufacturer’s specifications. Upon completion of service, service reports, sorted by serial number, shall be submitted to COR IAW ELIN A003.

1.2.4. Monthly Biological Validations. Biological validations (as per DoD 6055_18-M, Safety Standards for Microbiological and Biomedical Laboratories, 11 May 2010 and BTD SOP, see section 5) will be performed using a full run cycle for each autoclave or glassware washer on the equipment list (section 4). Upon completion of autoclave bio-validation, spore viability reports, sorted by serial number, shall be submitted to COR IAW ELIN A004.

2. General Requirements

2.1 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 are in the nature of personal services, or give the perception that personal services have been provided. 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 (CO) immediately.

2.2 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 CBC-BTD laboratory personnel and seek to ensure customer satisfaction and professional and ethical behavior of all contractor personnel.

2.3 Contract Administration and Management

2.3.1 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.

2.3.2 Contract Administration. The contractor shall establish processes and assign appropriate resources to effectively administer the requirement. The contractor shall respond to Government requests for contractual actions in a timely fashion. The contractor shall have a single designated point of contact between the Government and Contractor personnel assigned to support contracts or task orders. The contractor shall assign work effort and maintain proper and accurate time keeping records of personnel assigned to work on the requirement.

2.3.3 Personnel Administration. The contractor shall provide the following management and support as required. The contractor shall provide for employees during designated Government non-work days or other periods where Government offices are closed due to weather, lapses in federal appropriations, or security conditions. The contractor shall maintain currency of their employees by providing initial and refresher training as required to meet PWS requirements. Training materials will be provided to the COR IAW ELIN A007. The contractor shall make necessary travel arrangements for employees. The contractor shall 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).

2.4 Subcontract Management. The 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. The prime contractor will manage work distribution to ensure there are no Organizational Conflict of Interest considerations. Contractors may add subcontractors to their team after notification to the PCO or COR. Cross teaming may or may not be permitted.

2.5 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 match personnel skills to the work or task with a minimum of under/over employment of resources. The contractor shall ensure the labor categories, labor rates, and man-hours utilized in the performance of this service contract will be kept to the minimum necessary to accomplish the task. The Contractor shall provide the necessary resources and infrastructure to manage, perform, and administer the contract.

2.6 Location and Hours of Work. Accomplishment of the results contained in this PWS requires work at BTD, Dugway Proving Ground, and any of its additional facilities. Normal workdays are Monday through Thursday except US Federal Holidays. BTD employees typically work ten (10) hours per day, forty (40) hours per week, 0700 to 1730. Technical points of contact and the COR are expected to be available during core hours.

3. Performance Requirements

3.1. Preventative Maintenance. Quarterly on-site PM of all BTD autoclave and glassware washer systems (see equipment list, section 4) to enable operation at peak performance IAW manufacturers’ specifications as described in device manual(s). No exceptions. Over the course of each 4 quarters on the contract, PM services will typically include inspection, leak testing, lubrication, adjustment of door mechanisms, preventative replacement of door gaskets, annual cleaning/descaling of sterilizer chambers and replacement (as necessary) of components as applicable:

Solenoid valves, pneumatic valves, steam valves or other valves, filters, traps and/or other components such as pressure relief valves, water filters, steam regulators, and/or pneumatic cylinders.

3.2. Certification. Quarterly performance testing and certification of all BTD autoclave and glassware washer systems (see equipment list, section 4) with National Institute of Standards and Technology (NIST) heat and pressure probes traceable to American National Standards Institute (ANSI) standards (or validated by NIST traceable calibrator with current NIST certificate) to ensure all autoclave and glassware washer units are able to achieve defined temperature/pressure targets. Temperature calibrations must be accurate to ±0.25°C. Pressure calibrations must be accurate to within 0.025%. Contractor will develop schedule with COR to ensure that all systems are certified every 90 days IAW ELIN A002.

3.3. Emergency repair. Unlimited on-site assessment and repair of all BTD autoclave and glassware washer systems (see equipment list, section 4). After service is complete, each system must operate to manufacturers’ specifications. Response time from time-of-call (BTD to contractor) shall be within 24 hours.

3.4. Bio-Validation. Monthly biological performance validation of all ECBC-BTD autoclaves (see equipment list, section 4) using suitable commercial biological indicator kit acceptable to COR (as per guidance provided by BTD internal SOP, section 5). Kits will test for autoclave efficacy in killing of bacterial spores of Geobacillus stearothermophilus. Service to include validation of spore kill for each autoclave unit per month IAW ELIN A004.

3.5. Service Reports and/or Certificates. Proof of certification will be attached to the front of each unit. Service reports will be submitted to COR upon completion of all quarterly PM service encounters, all quarterly certifications, all emergency service calls, and all bio-validations IAW ELIN A001, A002, A003, and A004.

4.0 Equipment List:

4.1 Autoclave and glassware washer models

1501/1601/1600

1501/1601/1600

5. Bio Validation Guidance:

5.1 BTD Internal SOP Guidance. The following guidance is derived from BTD SOP (SOP RNB-485) which describes a procedure for the monthly required validation of all autoclaves. Adherence to this guidance allows 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.

5.2 Biological Validation of Autoclaves. 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.

NOTE: Biological indicators (spores of Geobacillus stearothermophilus, the most thermal-hardy spores on earth) will be processed within the recommended timeframe after completion of the validation autoclave cycle. 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.

5.3 Biological 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 will be approved by the COR.

5.4 A total of four (4) assays will be used per bio-validation test. Dry cycles employ a brown cap indicator tube (catalog no. 1292). Wet cycles use a blue cap indicator tube (catalog no. 1291).

5.4.1 The first assay is a positive control (not autoclaved; it will demonstrate growth of the test spores, because not subjected to sterilization). The three remaining Test Packs will be deployed as described below:

5.4.2 Assays 2-4 are equally distributed throughout the autoclave chamber.

5.4.3 One assay will be 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 an assay 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.

5.0 Cycle Time (dry materials). For autoclaves processing dry materials, e.g., trash, validation is performed at a minimum cycle time of 30 minutes and a cycle temperature of 132°C (270°F). A pre-vacuum (prevac) cycle begins the run to evacuate steam almost to zero (within 5 inches Hg). This allows steam to penetrate into all dry materials and bagged goods, as pulsing steam enters the chamber until the target temperature is achieved (temperature setting can be changed). This pattern of steam penetration and steam evacuation occurs four times in succession to achieve total penetration.

5.1 Cycle Time (wet materials). For autoclaves processing liquid materials (growth media, buffers, spent liquid culture) the parameters are different. There is no prevac cycle or rapid steam evacuation, else the liquid would boil off. Boil-over occurs if the pressure is released too quickly during exhaust phase. To prevent boil-over during the exhaust phase, the chamber pressure is released slowly. The bio validation Test Packs are different as well (blue caps) and the autoclave runs at a cooler temperature (121°C).

5.1.1 Cycle Time Completion. Once the cycle is complete and sensors have cooled enough for safe handling, follow the procedure for incubation of autoclaved spores as per assay product user manual.

5.1.2 Documentation of 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).

5.1.3 Use of Autoclave after bio-validation cycle. Once validated, the autoclaves can resume normal operations by laboratory staff.

5.7 Bio-Validation after PM Service/Repair. Upon completion of any autoclave PM service or repair, a bio-validation must be run before placing the autoclave back into BTD operation.

6.0 Security Requirements:

AT Level l training. This standard language is for contractor employees with an area of performance within an Army controlled installation, facility or area. All contractor employees, to include subcontractor employees, requiring access to Army installations, facilities and controlled access areas 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 is applicable. 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 30 calendar days after completion of training by all employees and subcontractor personnel. AT Level I awareness training is available at the following website: https://jko.jten.mil/courses/atl1/launch.html.

iWATCH Training. This standard language is for contractor employees with an area of performance within an Army controlled installation, facility or area. The contractor and all associated subcontractors shall brief all employees on the local iWATCH program (training standards provided by the requiring activity Anti-Terrorism Officer [ATO]). This local 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 CO. 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 NLT 30 calendar days after contract award.

Access and general protection/security policy and procedures. This standard language is for contractor employees with an area of performance within an Army controlled installation, facility, or area. Contractor and all associated subcontractors employees shall provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services or Security Office. Contractor workforce must comply with all personal identity verification requirements (FAR clause 52.204-9, Personal Identity Verification of Contractor Personnel) 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) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

For contractors that do not require a CAC, but require access to a DoD facility or installation. Contractor and all associated subcontractor employees shall comply with adjudication standards and processes 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.