A01_PWS_FINAL.docx

PERFORMANCE WORK STATEMENT

CERTIFICATION, MAINTENANCE, REPAIR AND DECONTAMINATION OF BIOSAFETY CABINET AND OTHER ENCLOSURES AT THE EDGEWOOD CHEMICAL BIOLOGICAL CENTER (ECBC)

1.0 Purchase Request: Certification, maintenance, repair and decontamination of biosafety cabinets and other enclosures at ECBC.

2.0 Activity: RDCB-DSR-H

3.0 Technical Point of Contact (POC): TBD

4.0 Administrative Contact: TBD

5.0 Type of Service Required

5.1 Semi-annual test and certification of 77 x Class II biosafety cabinets using procedures specified in National Sanitation Foundation (NSF) 49. Certifiers must be accredited under NSF 49 and company must be accredited to perform field testing of biosafety cabinets under ISO 17025.

5.2 Semi-annual test and certification of 3 x Class I biosafety cabinets, 5 x Class III biosafety cabinets and 15 x other HEPA filtered enclosures (such as clean benches/ PCR workstations, other laminar flow units and HEPA filter leak tests).

5.3 Decontamination, maintenance and repair of 5.1 and 5.2 (parts and labor included except for filters). Decontamination can be formaldehyde or hydrogen peroxide.

5.4 $5,000 budget for unscheduled certifications, repairs not otherwise covered by other 5.3, and unscheduled decontamination using formaldehyde or hydrogen peroxide

5.4 Priority response time for a service call

5.5 Rates for services such as unscheduled certifications including parts, labor and decontamination specified and rates for certification of equipment in a “hot” BSL-3 laboratory will be specified.

5.6 Certifications will be done in accordance with NSF 49 for Class II biosafety cabinets and manufacturer’s specifications for others except for Class III biosafety cabinets which will be certified in accordance with Appendix C.

5.7 Certifications will occur at various buildings at the Edgewood Chemical Biological Center at APG-South in Edgewood, Maryland

6.0 Background: ECBC’s mission is to be the Nation’s premier provider of innovative chemical and biological solutions. As a research, development and engineering center, much of the concepts developed and tested regarding the B (biological) occur in laboratories. The primary means of protecting personnel in the laboratories is through the Biological Safety Cabinet (BSC). Biological safety cabinets must be certified every 6-months, maintenance performed when needed and decontaminated when necessary (for example, before certain maintenance or before HEPA filter change-out). An experienced certifier accredited under the National Sanitation Foundation working under a company that has ISO 17025-2005 approved equipment/ methods to certify biosafety cabinets is required to perform these duties to ensure personnel are protected from the pathogens worked with at ECBC.

7.0 Period of Performance: Base (12 months) with 2 option years (12 months each) and option to extend (6 months)

8.0 Security Requirements.

8.1 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.

8.2 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- Ill) 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.

9.0 Semi-annual certification: Each item specified in Appendix A requires two service visits by the contractor per year. The contractor is responsible for tracking item due dates and for documenting the certification, maintenance or repair. Documentation of completed service will be provided to the COR or Technical POC. Service will include semi-annual certification and any decontamination and repairs (parts and labor)

10. Unscheduled Certifications/ Repairs: When notified of a needed on-site repair from the COR or Technical POC, the contractor will arrive on-site within 5 business days.

11.0 Principle Period of Maintenance (PPOM): Work will be performed 0730-1700, Monday through Friday. Work will not be performed on National Holidays (New Year’s Day, Martin Luther King Jr, President’s Day, Memorial Day, Independence Day, Lab Day, Columbus Day, Veteran’s Day, Thanksgiving, and Christmas Day).

12.0 Previous Contract Number: W91ZLK-16-P-0166

13.0 Contracting Officer’s Representative (COR) or Technical POC: TBD

14.0 Quality Assurance Surveillance Plan (QASP). Separate Document

16.0 APPLICABLE DOCUMENTS.

16.1 Department of Army Pamphlet 385-69: Safety Standards for Microbiological and Biomedical Laboratories, 06 May 2009. (This pamphlet may be obtained from: http://www.apd.army.mil/pdffiles/p385_69.pdf )

16.2 Biosafety in Microbiological and Biomedical Laboratories, 5th Edition, 2009. (This document can be found at: http://www.cdc.gov/biosafety/publications/bmbl5/.)

16.3 C.2.2.1 NSF/ANSI 49, Biosafety Cabinetry: Design, Construction, Performance, and Field Certification, 24 June 2016 (NSF/ANSI available at: http://www.techstreet.com/nsf/products/1893278)

17.0 Safety.

17.1 The contractor shall complete a visitor risk assessment to determine medical surveillance and training requirements prior to entering any ECBC laboratories.

18.0 Security.

18.1 This contract is unclassified and does not contain security requirements or a Contract Security Classification Specification, DD Form 254. However, the Government may require Operations Security (OPSEC) measures (when applicable) to protect sensitive unclassified contract information. If access to unclassified sensitive information (For Official Use Only - FOUO) is authorized, contractor may access only the information related to the subject matter of this contract.

18.2 The contractor shall not use foreign nationals on this contract unless approved by the Contracting Officer with Security Office concurrence. When requesting approval, the contractor shall furnish the following eleven items: Full Name; Date of Birth; Place of Birth; Citizenship; Registration Number; Type of Visa; Clear Copy of Picture Identification of Visa/Green Card/Permanent Resident Card; Port of entry; Title of Position to be filled; Abbreviated Curriculum Vitae; and Sole Source Justification of Employment to the Contract Specialist. These items will be reviewed by the Security Office with subsequent approval by the Contracting Officer. Previously approved foreign nationals must be re-approved if the nature of their work under this contract differs from that performed under the prior year’s contract.

18.3 The contractor shall ensure that foreign nationals approved for support of this effort will not have access to military technical or critical unclassified information. (The contractor may conduct a search through the Defense Technical Information Center to determine whether information is designated as military technical or critical unclassified information. Additional information is available from the Military Critical Technologies List (http://www.dtic.mil/mctl/).

18.4 Should the government determine that the technology has developed to a point where the information warrants protection, a DD Form 254 and an approved classification guide will be issued.

18.5 In accordance with restrictions required by Executive Order 12470, as amended, the Arms Export Control Act (Title 22, USC (Sec 275)), the International Traffic in Arms Regulation (ITAR), and/or Department of Defense (DoD) Directive 5230.25, Withholding of Unclassified Technical Data from Public Disclosure, foreign nationals shall not work on this contract without the express permission of the Contracting Officer.

18.6 A violation of administrative security procedures or export control regulations that would subject critical unclassified information to possible compromise by foreign visitors or foreign national employees shall immediately be reported to the cognizant facility security office and government security authorities.

18.7 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.

18.8 Contractor and all associated subcontractor employees shall comply with adjudication standards and processes using the National Crime Information Center Interstate Identification Index (NCICIll) 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.

Appendix A – Items to be certified

Appendix B –

CERTIFICATION PROCEDURES FOR CLASS III BIOSAFETY CABINETS

CLASS III BIOSAFETY CABINET CERTIFICATION WORK STATEMENT

The Class III BSC certification procedure consists of eight steps:

1) General Information

2) Class III BSC pressure gauges verification.

3) Intake and exhaust HEPA filters integrity test.

4) Class III BSC pressure leak test.

5) Working pressure and alarm check verification.

6) Gloveport breach containment verification.

7) ) Airlock interlock system operation

8) Complete test report and add certification stickers.

1. General Information.

The certifier should arrange for decontamination of the Class III BSC with the POC before arrival.

Measure room pressure in relation to adjacent room/hallway. Obtain information about building number, room number, Class III BSC model number and serial number, and lab POC.

2. Class III BSC pressure gauges verification.

Using the Class III BSC pressure test port, verify that pressure gauges in the Class III BSC are providing accurate readings, compare the pressure reading with the Class III BSC pressure gauges reading and verify if the gauges are in good working condition. If readings from Class III BSC gauges are within the calibrated instrument reading +/- 0.2 [in-wg], the Class III BSC pressure gauge verification is completed, continue to step (2).

If the pressure readings from Class III BSC gauges are not within the calibrated instrument pressure reading +/- 0.2 [in-wg], then Class III BSC gauges calibration is required; the certification cannot continue until Class III BSC pressure gauges are fixed.

3. Intake and exhaust HEPA filters Integrity test.

Test HEPA filters integrity using procedure indicated in NSF/ANSI 49, Annex F.5. Refer to Annex F.5.4 for acceptance criteria.

4. Pressure leak test.

The pressure leak test duration is 10 minutes, the test is performed with the gloves in place. The effect of gloves volume change due to pressure change is considered minimum for a 10 [min] test. This will allow to test the gloves for leaks as well. If the Class III BSC leak rate is more that the acceptable rate, then gloveport covers could be considered to isolate possible gloves leakage.

The procedure to leak test the Class III BSC is:

a. Gradually close intake and exhaust valves to maintain a negative pressure of approx. -2.0 [in- wg]. Special attention shall be taken during this process to avoid negative pressure below -5.0 [in-wg]. The intake valve should be completely closed before closing the exhaust valve.

b. Close the exhaust valve.

c. If negative pressure is lower than -2.0 [in-wg], slowly release Class III BSC pressure by slightly opening the intake valve until the pressure gauge reads approximately -2.0 [in-wg].

d. Wait approximately 30 [sec] to allow for Class III BSC pressure stabilization.

e. Using a calibrated instruments, record the initial time, Class III BSC pressure, internal air temperature, and room barometric pressure.

f. Wait 10 min and record the final time, Class III BSC pressure, internal air temperature, and room barometric pressure.

g. If temperature and/or barometric pressure has changed during the 10 [min] test, determine the pressure change by using the formula:

DP= (13.5955 x BP2+P2) x (T1+459.67)/(T2+459.67) - (13.5955 x BP1+P1)

Where:

· P1= Initial Pressure [in-wg]

· P2= Final Pressure [in-wg]

· T1= Initial Temperature [oF]

· T2= Final Temperature [oF]

· BP1= Initial Barometric Pressure [in-Hg]

· BP2= Final Barometric Pressure [in-Hg]

· DP= Pressure Change [in-wg] Note: If Class III BSC internal air temperature cannot be determine, then measurement of the temperature of the room area next to the Class III BSC will be acceptable only for temperature changes less than 1.0 [F], for greater temperature changes repeat the test.

h. Acceptance Criteria: If pressure change DP is greater than 0.25 [in- wg], then the test has failed and leaks shall be repaired, if pressure change is less than 0.25 [in-wg], then the test passed.

5. Operational pressure and alarm check verification.

The Class III BSC must be set to its working pressure; the Class III BSC pressure can be adjusted by changing the intake valve position. As the valve is moved closer to the close position, the pressure within the Class III BSC will increase.

The Class III BSC working pressure is normally set at -1.0 [in-wg], the alarm is set to activate at -

0.5 [in-wg] of pressure. If the Class III BSC pressure cannot be set at - 1.0 [in-wg], other working pressure and alarm set point can be selected but the minimum acceptable Class III BSC pressure is -0.25 [in-wg].

Record the Class III BSC working pressure and verify that the alarm activates at the set point by means of slowly reducing Class III BSC pressure when closing the Class III BSC exhaust valve, do not close exhaust valve completely. If test is successful, set the Class III BSC pressure to its original condition, if alarm does not activate, the Class III BSC failed the test.

6. Gloveport breach containment verification.

A temporary opening can be produced by an accidental gloveport breach during gloves change out procedure. Temporary openings in a gloveport must maintain an inward flow of at least 100 linear feet per minute (lfpm).

The airflow amount through a gloveport is determined by the position of the Class III BSC exhaust valve.

The airflow through the gloveport will not be measured directly on an opened gloveport but instead will be estimated by measuring the Class III BSC intake airflow.

a. Determine average Class III BSC intake flow Q1.

· Adjust Class III BSC intake valve to full open position.

· Using a calibrated instrument, determine the average velocity (V) [fpm] at the Class III BSC inlet connection.

· Measure Class III BSC intake diameter (d1) in inches and determine the intake area using: A1 = π*(d1)2/576 [ft2]

· Then obtain the average Class III BSC intake flow. Q1 = V*A1 [cfm]

b. Determine gloveport area.

1. For round gloveports measure the inside diameter (d2) in inches and calculate the area using: A2 = π*(d2)2/576 [ft2]

2. For oval gloveports measure axis (a) and (b) in inches and calculate the area using: A2 = π*a*b/576 [ft2]

c. Assuming the Class III BSC intake flow Q1 is equal to the gloveport intake flow, calculate the gloveport intake airflow velocity.

The calculated gloveport intake airflow velocity is: V2 = Q1/A2 [fpm]

d. Verify that gloveport intake velocity V2 is greater than 100 [fpm] and less than 150 [fpm].

100 [fpm] < V2 < 150 [fpm] Adjust exhaust valve as needed until required flow is obtained. If possible mark exhaust valve final position.

e. Adjust intake valve to Class III BSC operational pressure of 1.0 [in-wg].

7. Airlock interlock system operation Verify proper operation of the airlock interlock system by opening one door and checking the opposite door is locked. Both the inner and outer doors shall be verified.

8. Complete test report and add certification stickers.

Complete test report including all testing results and add certification stickers.

Class III Biosafety Cabinet Certification Check List

· Room Pressure

· Class III BSC Pressure Gauge Verification

· Set inlet valve to Class III BSC pressure to approximately -1.0 [in-wg]

· Connect calibrated instrument tubing to test port and measure pressure

· Verify that both pressure readings are within +/- 0.2 [in-wg]

· Intake and Exhaust HEPA Filters Integrity Test

· Set inlet valve to Class III BSC pressure to approximately -1.0 [in-wg]

· Connect calibrated instrument tubing to test port and measure pressure

· Verify that both pressure readings are within +/- 0.2 [in-wg]

· Pressure leak Test

· Turn off Class III BSC lights

· Close inlet valve

· Close exhaust valve

· Set Class III BSC pressure to approximately -2.0 [in-wg]

· Wait 30 [sec]

· Record initial time, pressure, barometric pressure, and temperature

· Wait 10 [min]

· Record final time, pressure barometric pressure, and temperature

· Calculate pressure change

· Verify calculated pressure change is less than 0.25 [in-wg]

· Alarm Verification

· Verify alarm activates at -0.5 [in-wg]

· Gloveport Breach

· Adjust Class III BSC intake valve to full open position

· Determine average velocity at the Class III BSC air intake connection

· Calculate Class III BSC intake area and determine intake flow (cfm)

· Record Class III BSC air intake flow

· Determine gloveport area

· Calculate gloveport intake airflow velocity (using Class III BSC intake flow)

· Verify that Class III BSC intake velocity is: 100 [fpm] < V < 150 [fpm]

· Operational Pressure

· Set Class III BSC pressure to -1.0 [in-wg]

· Verify Airlock Interlock System operation

· Fill survey form (provided by ECBC Safety & Health Office), sign add stickers to Class III BSC