PWS_Autoclaves.pdf

Edgewood Chemical Biological Center – Bio Testing Division (ECBC-BTD) - Dugway Autoclaves

Performance Work Statement (PWS)

Vision: To procure a service contract that assures consistent and calibrated operation of 20 (twenty) autoclaves for the Edgewood Chemical Biological Center – Bio Testing Division (ECBC-BTD), located at ECBC Dugway Campus, Bldg. 2029, Dugway Proving Ground, UT 84022-5004.

1. Introduction. The developmental and operational testing of biological defense systems at the ECBC-BTD at Dugway Proving Ground (DPG) requires the ability to sterilize test materials and test equipment. ECBC-BTD has a requirement to sustain its autoclave systems. Several manufacturers and service companies employ autoclave technicians who can meet this requirement and provide routine maintenance, repair and performance validation.

1.1 Mission. The ability to sterilize equipment and biological test materials with high reliability in accordance with (IAW) the requirements of the biological defense Testing and Equipment program. This capability provides the sterilization needed to effectively evaluate the performance of referee biological detection and identification equipment and/or systems under test to support National and Department of Defense (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 Biomedial Laboratories 11 May 10

1.1.1.2 ECBC-BTD SOP

1.1.1.3 ECBC-BTD SOP RNB-485

1.2 Scope. A commercial service contract which the Contractor shall provide the following for all twenty autoclaves: quarterly preventative maintenance (PM), quarterly certification, unlimited 24-hr emergency repairs, monthly biological validations (autoclaves only), modification of autoclave control panels to enable digital data tracking; and the rebuild of one autoclave. All validation and certification encounters will include a full run check cycle.

All encounters will be followed up with a service report in accordance with (IAW) exhibit line item number (ELIN) A001.

1.2.1. Quarterly PM on All Autoclaves. To enable operation at peak performance IAW manufacturers’ specifications. Upon completion of PM, service reports, sorted by serial number, shall be submitted to Contracting Officer’s Representative (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 proof of certification stickers 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 (ECBC-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 Biomedial Laboratories, 11 May 10 and ECBC-BTD SOP, see section 5) will be performed using a full run cycle for each autoclave on the equipment list (section 4). Upon completion of bio-validation, spore viability reports, sorted by serial number, shall be submitted to COR IAW ELIN A004.

1.2.5. Digital Data Tracking System Modifications. Autoclave control panel modifications (i.e., Digital Data Tracking System) shall be made for each autoclave (see equipment list, section 4) as specified in section 3.5. Upon completion of each autoclave modification, service reports, sorted by serial number, shall be submitted to COR IAW ELIN A005.

1.2.6 Rebuild Autoclave. Rebuild one Steris model autoclave, as specified in section 3.6.

Upon completion of autoclave rebuild, a service report shall be submitted to COR IAW ELIN A006.

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 purchasing contracting officer (PCO) 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 ECBC-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 ECBC-BTD Dugway Proving Ground and any of its additional facilities.

Normal workdays are Monday through Thursday except US Federal Holidays. ECBC-BTD workers typically work ten (10) hours per day, forty (40) hours per week, 0700 to 1730.

The technical point of contact and COR are expected to be available during core hours.

3. Performance Requirements

3.1. Preventative Maintenance. Quarterly on-site PM of all ECBC-BTD autoclave 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 3 quarters, 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 ECBC-BTD autoclave systems (see equipment list, section 4) with heat and pressure probes National Institute of Standards and Technology (NIST) traceable to American National Standards Institute (ANSI) standards (or validated by NIST traceable calibrator with current NIST certificate) to ensure all autoclave 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 ECBC-BTD autoclave systems (see equipment list, section 4). After service is complete, each system must operate to manufacturers’ specifications. Response time from time-of-call (ECBC-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 ECBC-BTD internal SOP, section 5). Kits will test for autoclave efficacy in killing bacterial spores of Geobacillus stearothermophilus. Service to include validation of spore kill for each autoclave unit per month IAW ELIN A004.

3.5. Modify Controls to Include Digital Data Tracking System. Contractor will modify each ECBC-BTD autoclaves (see equipment list, section 4), as applicable, with suitable digital data tracking system interfaced between control board and printer so that cycle data can be captured onto portable memory storage device(s) for archival purposes. Contractor must be able to provide modification data to the Government upon request by COR throughout the duration of the contract IAW ELIN A008.

3.6. Rebuild Autoclave. Rebuild autoclave model below IAW manufacturer specifications.

Upon completion of each autoclave rebuild a service report will be submitted to the COR

IAW A006:

ECBC-BTD

Building/Room Model Serial #

Additional identifying features

2029/504

Steris model R3043-S-1 (currently outfitted with Steris VHP M100-AB bio decontamination system with Allen-Bradley controls)

R8314308-07 Room 504 #3; pass-through from room 913 (BSL-3) to room

504 (BSL-2)

1. Rebuild of Autoclave to be done with sterilizer in current location

2. All plumbing to be replaced with new brass fittings

3. All plumbing should be installed IAW BSL‐3 lab installation

4. Rip out VHP generator and associated fittings

5. Make sure all caustic chemicals are removed/decontaminated

6. Ensure integrity of excess autoclave chamber ports

7. Replace current steam regulator with new steam regulator

8. Steam Traps replaced with new thermostatic steam traps

9. Replace pressure relief valves to match vessel pressure rating

10. Re‐insulate vessel

11. Clean Chamber

12. Replace Vacuum Pump

13. Complete rebuild of both chamber doors

14. Solenoid pneumatic control valves must include illuminated coils for easy trouble-shooting

15. Replace current controls (both sides) with color touch screen controllers optimized for BSL‐3 activities

16. Controller must include a minimum of 25 programmable cycles

17. Control must have three levels of user access, Administrator, Supervisor, and

Operator

18. Control system must have temperature accuracy of ± 0.5 degrees Celsius

19. Control must utilize temperature sensors with an accuracy of ± 0.5 degrees Celsius

20. Control should include a print on paper cycle printer

21. Rebuilt autoclave should include digital data tracking system interfaced between control board and printer so cycle data can be captured onto portable memory storage device.

22. New controls must provide interlock between hot and cold areas

23. Rebuild door interlock system

24. Replace Jacket and Chamber pressure gauges

25. HEPA inlet air filtration system should be installed on sterilizer

26. Replace Heat Exchanger

27. Replace Door Bearings

3.7 Service Reports and/or Certificates. Proof of certification stickers will be adhered 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 Lists:

4.1 Autoclave Models.

Building/Room Model Serial # Additional identifying features

1 2028/902 Primus F 17289 #1 pass-through

2 2028/902 Primus F 17288 #2 pass-through

3 2028/902 Primus F 17287 #3 pass-through

4 2028/906 Systec DX-150-2D D2028 Attached to WSLAT chamber

5 2028/906 Systec DX-150-2D D2029 Attached to WSLAT chamber

6 2028/906 Systec DX-150-2D D2030 Attached to WSLAT chamber

7 2029/218 Tuttnauer 5596SP-IR 2608055 #1; kitchen

8 2029/218 Steris SV3033 131702-07 #2; kitchen

9 2029/218 Primus PSS5-B-MSSD 17120 #3; kitchen

10 2029/218 Primus PSS5-B-MSSD 17121 #4; kitchen

11 2029/504 Steris SV3053 0135000-04 #1; pass-through from room 912 (BSL-3) to room 504 (BSL-2)

12 2029/504 Steris SV3053 0134900-18 #2; pass-through from room 912 (BSL-3) to room 504 (BSL-2)

13 2029/504

Steris (currently outfitted with Steris VHP M100-AB bio decontamination system with Allen-Bradley controls)

0100909-01 #3; pass-through from room 913 (BSL-3) to room 504 (BSL-2)

14 2029/600 Steris SV3053 0132202-10 This autoclave is in the 700 hallway

15 2029/910 Amsco, model: FINN-AQUA, unit #: B300899-652

0135596-05 This autoclave is located in the same room that encloses the CAC chamber

16 LSTF Annex/AC2/1413 Primus model F

17 LSTF Annex/AC2/1413 Primus model F

LSTF Annex/AC1 1501/1601/1600

Primus model L Pass-through

LSTF Annex/AC1 1501/1601/1600

Primus model L Pass-through

20 2032/north end Primus C 1955 C9415.1256

5. Bio Validation Guidance:

5.1 ECBC-BTD SOP Guidance. The following guidance is derived from ECBC-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 Autoclave. Performance is to be done every month or after any maintenance has been performed on ECBC-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 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 Test Sensors. A total of four test sensors will be used per autoclave bio-validation test.

5.4.1 Sensor 1. The first sensor (sensor 1) will be a positive control (and is not autoclaved). The three remaining sensors will be deployed as described below.

5.4.2 Sensor 2. Sensor 2 will be placed in a heat-resistant (to 135°C) biohazard autoclave bag (24 x 36 inches, VWR cat no. 14220-070). It will be placed at the rear of the chamber.

5.4.3 Sensor 3. Sensor 3 will be placed in the center of the autoclave chamber.

5.4.4 Sensor 4. Sensor 4 will be placed in a heat-resistant biohazard autoclave bag toward the front of the autoclave.

5.4.4.1 It is essential that bags and sensors be evenly distributed throughout the autoclave chamber. Many autoclaves feature a single platform; in this case, one bag will be placed in the back and one bag will be placed in the front, with an un-bagged sensor in between them. ECBC-BTD, however, has a number of very large autoclaves. In these cases, it will be necessary to arrange the two bags and three sensors in as balanced a manner as possible, taking into account the vertical distance from floor to ceiling within the autoclave chamber.

5.5 Standardized Bag Size, Contents and Opening. In order for bio-validations to be similar-to-identical from bio-validation to bio-validation, the bags will be packed minimally (in addition to the bio sensor) to half-full with simulated laboratory trash. This will consist of crumpled up paper towels, 1 pair of used latex or nitrile laboratory gloves, an empty one gallon plastic bleach bottle, bits of cardboard and/or laboratory plastic (pipettes, pipette tips, microfuge tubes, test tubes, 96-well plates, etc., as available), and 5 mL water. A 5-inch opening will be created at the top of the bag, using string and/or tape to ensure that steam efficiently penetrates to the interior contents of the bag.

5.6 Cycle Time. Validate at a minimum cycle time of 30 minutes and cycle temperature of 132°C (270°F). It is permissible to walk back the conditions to shorter times and lower temperatures so long as the autoclave continues to successfully pass monthly bio-validation challenges.

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

5.6.2 Documentation of Cycle Times. All cycles and validations will be documented by the contractor in a validation report, to be submitted to the COR, to include whether or not the bio validation passed (100% spore kill) or failed (1 or more viable spores indicates failure).

5.6.3 Use of Autoclave after Cycle Time. 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 ECBC- BTD operation.