Primary_Barrier_Solicitation_071919_.docx

Standard Form (SF) 1449, Solicitation/Contract Order for Commercial Items to be completed at time of award.

Addendum - Continuation of SF-1449 (Blocks 19-24)

Base Period September 1, 2019 through August 31, 2020

001. The Contractor shall provide regular service to consist of performing (1) on-site certification/testing of the equipment and systems listed below in items 001.1 through 001.116 during the contract period. In addition, for items 001.3 through 001.8, the Contractor shall provide repair as indicated in Section C, Statement of Work.

CLIN Description Estimated Quantity Unit

001.1 Chemical Fume Hoods 1,100 Each

001.4 Class II, Type A 2,600 Each

Biological Safety Cabinets

001.6 Class II, Type C 2 Each

001.11 Autoclaves 5 Each

001.12 Utility Systems

Exhaust units

001.12.5 Magnehelic HEPA Filters 325 Each

002 Provide decontamination 4,100 Hours Services of systems, components and rooms at times other then required for CLIN 001 above

cover labor for inspections, miscellaneous partial test requests such as face velocity checks, etc., that the Project Officer may deem necessary between annual maintenance inspections

Option Year I Period September 1, 2020 through August 31, 2021

007. The Contractor shall provide regular service to consist of performing (1) on-site certification/testing of the equipment and systems listed below in items 007.1 through 007.116 during the contract period. In addition, for items 007.3 through 007.8, the Contractor shall provide repair as indicated in Section C, Statement of Work.

CLIN Description Estimated Quantity Unit

007.1 Chemical Fume Hoods 1180 Each

007.4 Class II, Type A 2,675 Each

Biological Safety Cabinets

007.6 Class II, Type C 2 Each

007.11 Autoclaves 5 Each

007.12 Utility Systems

Exhaust units

007.12.5 Magnehelic HEPA Filters 335 Each

008 Provide decontamination 4,200 Hours Services of systems, components and rooms at times other then required for CLIN 001 above

cover labor for inspections, miscellaneous partial test requests such as face velocity checks, etc., that the Project Officer may deem necessary between annual maintenance inspections

Option Year II Period September 1, 2021 through August 31, 2022

013. The Contractor shall provide regular service to consist of performing (1) on-site certification/testing of the equipment and systems listed below in items 013.1 through 013.116 during the contract period. In addition, for items 013.3 through 013.8, the Contractor shall provide repair as indicated in Section C, Statement of Work.

CLIN Description Estimated Quantity Unit

013.1 Chemical Fume Hoods 1,190 Each

013.4 Class II, Type A 2,700 Each

Biological Safety Cabinets

013.6 Class II, Type C 2 Each

013.11 Autoclaves 5 Each

013.12 Utility Systems

Exhaust units

013.12.5 Magnehelic HEPA Filters 345 Each

014 Provide decontamination 4,300 Hours services of systems, components and rooms at times other then required for CLIN 001 above

cover labor for inspections, miscellaneous partial test requests such as face velocity checks, etc., that the Project Officer may deem necessary between annual maintenance inspections

Option Year III Period September 1, 2022 through August 31, 2023

019. The Contractor shall provide regular service to consist of performing (1) on-site certification/testing of the equipment and systems listed below in items 019.1 through 019.116 during the contract period. In addition, for items 019.3 through 019.8, the Contractor shall provide repair as indicated in Section C, Statement of Work.

CLIN Description Estimated Quantity Unit

019.1 Chemical Fume Hoods 1,200 Each

019.4 Class II, Type A 2,750 Each

Biological Safety Cabinets

019.6 Class II, Type C 2 Each

019.11 Autoclaves 5 Each

019.12 Utility Systems

Exhaust units

019.12.5 Magnehelic HEPA Filters 355 Each

020 Provide decontamination 4,300 Hours Services of systems, components and rooms at times other then required for CLIN 001 above

cover labor for inspections, miscellaneous partial test requests such as face velocity checks, etc., that the Project Officer may deem necessary between annual maintenance inspections

Option Year IV Period September 1, 2023 through August 31, 2024

025. The Contractor shall provide regular service to consist of performing (1) on-site certification/testing of the equipment and systems listed below in items 025.1 through 025.116 during the contract period. In addition, for items 025.3 through 025.8, the Contractor shall provide repair as indicated in Section C, Statement of Work.

CLIN Description Estimated Quantity Unit

025.1 Chemical Fume Hoods 1,225 Each

025.4 Class II, Type A 2,800 Each

Biological Safety Cabinets

025.6 Class II, Type C 2 Each

025.11 Autoclaves 5 Each

025.12 Utility Systems

Exhaust units

025.12.5 Magnehelic HEPA Filters 365 Each

026 Provide decontamination 4,300 Hours Services of systems, components and rooms at times other then required for CLIN 001 above

cover labor for inspections, miscellaneous partial test requests such as face velocity checks, etc., that the Project Officer may deem necessary between annual maintenance inspections

PRIMARY BARRIER EQUIPMENT & DECONTAMINATION SERVICES WORK STATEMENT

The following format is used for this statement of work:

1. Introduction

2. Scope

3. Performance Requirements/Work Areas

4. Work Manner and Time

5. Reports

6. Staffing

7. Performance Objectives

8. Performance Evaluation Management Plan

1. Introduction

The National Institutes of Health (NIH) is the US Federal Government’s focal point for medical research. As such, it is the largest biomedical research complex in the United States. Included in this complex are research laboratories at all Biosafety Levels up to and including Biosafety Levels 3 and 4, animal care and use facilities, a clinical research facility, administrative offices, and industrial shops and services. These activities are located on the main NIH campus in Bethesda, MD, the Baltimore/Washington area, the Rocky Mountain Laboratories in Montana, and the Integrated Research Facility in Frederick, MD. The NIH Division of Occupational Health and Safety (DOHS) is responsible for conducting a comprehensive intramural safety program to create and maintain a safe and healthful environment for NIH patients, employees, visitors, and guest workers.

2. Scope

2.1 General

This contract is for use by the entire NIH community with orders being issued by OLAO acquisitions. NIH authorized ordering officials are expected to place orders against this contract directly with the contractor in accordance with the terms and conditions, herein.

2.2 Types of Work

The contractor shall be responsible for the following types of work under this contract and for the instrumentation identified herein:

1. Monitoring

2. Certification

3. Preventive Maintenance

4. Repair

5. Decontamination

6. Neutralization

7. Inspection/Assembly/Disassembly

2.3 Contract Coverage

Only instruments/equipment identified herein are covered by the terms and conditions of this contract. Stored instruments/equipment is not covered under this contract.

2.4 Resources

The contractor shall be responsible for, independently, and not as an agent of the Government, furnishing all necessary personnel, labor, special tools, engineering upgrades, facilities, diagnostic equipment, parts, materials (except filters), and supplies to provide required technical support and expertise for on-site preventive maintenance, inspection, certification, decontamination, and repair of Government owned instruments, equipment and laboratory areas identified herein.

2.5 Government Furnished Equipment (GFE)/Information (GFI) Facilities

a. The contractor shall maintain an inventory accounting system for GFE. The contractor shall provide the COR with the information necessary to manage GFE under this SOW. All Government Property should be maintained per FAR Clause 52.245-1-Government Property

b. The contractor will have access to use five (5) Government owned Certek HR 1414 Formaldehyde Gaseous Decontamination Machines and two (2) Nextek 5K Formaldehyde Gaseous Decontamination Machines located at Building 28, Rocky Mountain Lab; six (6) Certek/Nextek HR 1414 Formaldehyde Gaseous Decontamination Machines at the Frederick Integrated Research Facility and two (2) Government owned Certek HR 1414 Formaldehyde Gaseous Decontamination Machines located on the NIH Main Campus for use to decontaminate HVAC HEPA filter housings and small rooms as appropriate. The contractor will have access to use, if required by the Government, one (1) Government owned ClorDiSys Minidox-M Chlorine Dioxide Decontamination System located at Building 28, Rocky Mountain Lab, and one (1) Government owned ClorDiSys Minidox-M Chlorine Dioxide Decontamination System located at the Frederick Integrated Research Facility.

c. Upon completion of development, tablets will be supplied for secure data entry by technicians. Each tablet will be equipped with a power supply, rugged case and stylus. Tablets will be supplied for technicians working at Building 33 on the Main Campus in Bethesda, the Integrated Research Facility, Frederick, MD and Rocky Mountain Laboratory in Hamilton, MT.

d. All network accessible equipment (pc’s, tablets, printers/copiers) are securely configured by ORS/ITB before use. Tablets will be supplied with secure wireless access to the NIH CERTS application.

e. On-site space for administrative staff and technicians will be provided with desktop workstations, as necessary, wired and wireless network connectivity, NIH helpdesk support to troubleshoot PC-related problems, laser printer/copier access, and shredder to allow the disposal of Privacy Act Materials. Some GFI may include PII.

f. Contractor is expected to maintain an accurate and up to date inventory of all government supplied equipment in its possession. The contractor shall be responsible for equipment that are lost, stolen or damaged while the equipment is in the possession of Contractor personnel.

3. Performance Requirements/Work Areas

3.1 Performance Requirements

Each performance requirement will contain the following three elements. In each case when taken together, these elements constitute a performance requirement. Any non-acceptable service such as failure to achieve a performance requirement shall be promptly rectified by the contractor at no additional cost to the government.

Performance Objective - A statement of the outcome or results expected in a specific task area. These objectives may be identified in the basic contract for each task area.

Performance Measure - The critical few characteristics or aspects of achieving the objective that will be monitored by the Government, those things about which the Government will be gathering data.

Performance Expectations - The targeted level for range of levels of performance for each performance measure. These expectations may be identified in the basic contract.

3.2. Equipment and Systems to be serviced

The following types of equipment and containment system components shall be serviced under this contract:

- Class I Biological Safety Cabinets

- Class II, Type A Biological Safety Cabinets

- Class II, Type B Biological Safety Cabinets

- Class II, Type C Biological Safety Cabinets (non-ducted)

- Class III Biological Safety Cabinets

- Air exhaust and supply plenum HEPA filters

- Autoclave vent/vent stack HEPA filters

- Breathing air/vacuum/CO2/oxygen HEPA filters

- Magnehelic HEPA equivalent filters

- HEPA filtered vacuum cleaners and HEPA filtered powered exhaust units (asbestos barrier filters)

- Chemical Fume Hoods

- Calibration of Chemical Fume Hood Alarms

- Local Exhaust Systems (i.e., downdraft tables and sinks, slot hoods, and miscellaneous systems)

- Laminar Flow Clean Benches

- Laminar Flow Patient Isolator HEPA filters

- HEPA filtered Animal Care Modules (including, but not limited to, animal racks and turbo units)

- Autoclaves

3.3. Service/Annual Certifications

Independently and not as an agent of the Government, the contractor shall perform annual certification for specified equipment. Annual certification includes all scheduled service provided by the Contracting Officers Representative (COR). Annual certification for each piece of equipment shall be performed once each fiscal year and within one year of the previous certification. Any exceptions requiring more frequent certifications other than annually must be approved by the COR prior to any work being performed. However, certifications associated with the Clinical Center Pharmacy and animal facility pharmacies shall be performed on a six (6) month basis. All of these services shall be initiated by the contractor and include all necessary work to complete the certifications as follows:

3.3.1. Service/Annual Certification for Class II, Type A, B and C Biological Safety Cabinets

a. Perform field testing in accordance with "NSF International/American National Standard 49-2016 (NSF/ANSI 49-2016)" or most recent version, on newly installed and moved units and annually thereafter, except for the following Worker Comfort and Safety Tests: lighting intensity, vibration, noise level, and electrical leakage.

b. Provide and install motors, switches, fluorescent light tubes, blowers, static pressure plates in blowers, solid state blower speed controllers, microprocessor control boards, ballasts for fluorescent lights, circuit breakers, fuse holders, ground fault interrupters, window clamps, and other similar components as required by the COTR. All replacement parts shall be equal to the equipment manufacturer’s specifications

c. Perform leveling of cabinets

d. Repair and install, HEPA filters and remove and dispose of used HEPA filters (NIH is responsible for disposal of filters in Class IIB cabinets)

e. Perform gaseous decontamination and neutralization of equipment prior to repairing or replacing components located in contaminated plenums. Gaseous decontamination and neutralization of equipment shall also be performed prior to certification on all Type B cabinets used with biological hazards and Type A and Type C cabinets used with vaccinia, EBV, TB, slow viruses or other BSL3 and BSL 4 agents. Primary gaseous decontamination agent used is paraformaldehyde. The Government reserves the right to change the gaseous decontaminant agent to be used if required. Gaseous chlorine dioxide or hydrogen peroxide is possible gaseous decontamination options, but their use will be solely at the direction of the Government. As such, the contractor shall have the means and experience to perform these alternative methods if required. Decontamination methods used, including alternative methods, shall be EPA registered methods under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

f. Test, adjust, and repair cabinet alarms and replace those which cannot be brought into proper calibration

3.3.2. Annual Service for Laminar Flow Clean Benches

a. Leak test and repair HEPA filter systems

b. Install, remove and dispose of HEPA filters

c. Provide all applicable components and labor referred to in paragraph 3.3.1.b and according to manufacturer’s specification

d. Perform all applicable tests referred to in 3.3.1.a

3.3.3. Service/Annual Certification for Class I Biological Safety Cabinets

a. Perform all applicable tests and service for HEPA filters for Class I cabinetry that are referred to in Article 3.3.1.a

b. Repair and install HEPA filters and remove and dispose of used HEPA filters.

c. Repair and install cabinet alarms and replace defective alarms which cannot be brought into proper calibration

d. Provide all applicable components and labor referred to in paragraph 3.1.b

3.3.4. Service/Annual Certification for Class III Biological Safety Cabinets

a. Perform on-site certification/test which includes decontamination and neutralization of cabinet and leak testing and repairing of HEPA filters in accordance with certification procedures in III.B.6 of the "Laboratory Safety Monograph, A Supplement to the NIH Guidelines for Recombinant DNA Research". The substitution for Halogen shall be one that is recognized by the biohazard cabinetry industry (at the present time, helium is acceptable). The leak test shall include repairing leaks and re-testing until all leaks are eliminated. The Class III cabinet system shall be leak tested and certified completely under a separate charge for each unit.

b. Measure exhaust quantity of the cabinet

c. Test Ground fault interrupters

d. Test for ground continuity

e. Test and replace cabinet gloves (gloves will be provided by NIH)

f. Install new HEPA filters and remove and dispose of used HEPA filters

g. Test, adjust and repair cabinet alarms and replace defective alarms which cannot be brought into proper calibration

h. Determine airflow in accordance with manufacturer specifications.

3.3.5. Service/Annual Certification for HEPA Filtered Animal Care Modules

a. Leak test and repair HEPA filter systems

b. Install, remove and dispose of HEPA filters

c. Provide all applicable components and labor referred to in paragraph 3.3.1.b

3.3.6. Service/Annual Certification for Laminar Flow Patient Isolator HEPA Filters and Isolator Booths

a. Test, repair, install, remove and dispose of HEPA filters

b. Test alarms and note failures on the Contractor’s Service Report

c. Report alarm failures to the COR by phone from the location of the equipment

3.3.7. Validation/Service Certification for Autoclaves

Certify, as required by the COR, autoclaves according to the "Laboratory Safety Monograph, A Supplement to the NIH Guidelines for Recombinant DNA Research"

3.3.8. Annual Certification for Utility System Parts Consisting of: Exhaust and Supply Air Plenum HEPA Filters, Autoclave Vent/Stack HEPA Filters, Vacuum Line//Breathing Air/Carbon Dioxide/Oxygen Building Services HEPA Filters, Miscellaneous Vent/Stack HEPA Filters

Certification includes leak test, repair, maintenance, decontamination, removal, installation and disposal of HEPA filters

3.3.9. Annual Certification of Chemical Fume Hoods, Local Exhaust Systems (i.e., Downdraft Tables and Sinks, Slot Hoods, and any other local exhaust system)

Perform certification according to the "NIH Certification of Chemical Fume Hoods (Attachment 2)", "Iodination Hood Certification Procedure (Attachment 3)", and the "NIH Procedure for Local Exhaust Ventilation (Attachments 4-8 & 10)"

3.3.10. Calibration of Chemical Fume Hood Alarms

Perform calibration to alarm manufacturers specifications when found to be out of calibration during Certification of Chemical Fume Hoods.

3.3.11. Miscellaneous Services

a. Provide and install windows in Class II Types A and B Biological Safety Cabinets (charged on a unit basis).

b. Decontaminate equipment, systems and laboratories or other large spaces as required by special program (charges will be on a labor hour basis). These services shall be performed at the specific request of the COR or the COR’s designated representative and charged on an labor hour basis.

c. Inspect, assemble, disassemble, and partially test equipment, or systems at the request of the COR or the COR’s designated representative (charged on a labor hour basis).

d. Perform other required tasks related to maintenance and testing of the primary barrier equipment at the NIH.

3.4. Emergency Services

Independently and not as an agent of the Government, the contractor shall perform emergency services as follows:

3.4.1. NIH Locations, Bethesda, MD and facilities in the Baltimore/Washington Metropolitan Area

a. Required services, other than the scheduled annual certifications

b. Certifications for new equipment or facilities

c. Emergency requests shall be responded to, on-site, within two (2) working days after receipt of request

d. Emergency requests shall be kept in an NIH Emergency Service Call Log and in a location readily available to the COR

e. The NIH Emergency Service Call Log shall include, at a minimum, the date and time of the request; the date and time the request was picked-up by the contractor; the name, phone number, building and room number of the requestor; the nature of the request; the date scheduled; and the date the work is completed. If the work is not completed at the time of the first visit, the reason shall be put in a comment section of the NIH Emergency Service Call Log; required parts on order; the date order was placed; the source of the parts; when parts were received.

f. Any pertinent update information regarding parts shall be included in the comments section of the NIH Emergency Service Call Log

g. More information may be required in the log during the course of the contract

h. When deemed necessary by the COR, the contractor shall provide emergency service after normal working hours or on weekends in extreme emergency cases or when the area involved needs to be unoccupied. All preparation will be coordinated between the COR and the on-site supervisor.

3.4.2. Rocky Mountain Laboratories, Hamilton, Montana

b. Certifications for new equipment or facilities

c. Emergency requests shall be responded to, on-site, within two (2) working days after receipt of request, except for Building 28 Integrated Research Facility.

Emergency requests in Building 28 shall be responded to, on-site within eight (8) hours after receipt of request.

d. Emergency requests shall be kept in an NIH Emergency Service Call Log and in a location readily available to the COR

e. The NIH Emergency Service Call Log shall include, at a minimum, the date and time of the request; the date and time the request was picked-up by the contractor; the name, phone number, building and room number of the requestor; the nature of the request; the date scheduled; and the date the work is completed. If the work is not completed at the time of the first visit, the reason shall be put in a comment section of the NIH Emergency Service Call Log; required parts on order; the date order was placed; the source of the parts; when parts were received.

f. Any pertinent update information regarding parts shall be included in the comments section of the NIH Emergency Service Call Log

h. When deemed necessary by the COR, the contractor shall provide emergency service after normal working hours or on weekends in extreme emergency cases or when the area involved needs to be unoccupied. All preparation will be coordinated between the COR and the on-site supervisor.

3.4.3. Frederick Integrated Research Facility, Fort Detrick, Frederick, Maryland

b. Certifications for new equipment or facilities

c. Emergency requests shall be responded to, on-site, within eight (8) hours after receipt of request.

d. Emergency requests shall be kept in an NIH Emergency Service Call Log and in a location readily available to the COR

e. The NIH Emergency Service Call Log shall include, at a minimum, the date and time of the request; the date and time the request was picked-up by the contractor; the name, phone number, building and room number of the requestor; the nature of the request; the date scheduled; and the date the work is completed. If the work is not completed at the time of the first visit, the reason shall be put in a comment section of the NIH Emergency Service Call Log; required parts on order; the date order was placed; the source of the parts; when parts were received.

f. Any pertinent update information regarding parts shall be included in the comments section of the NIH Emergency Service Call Log

h. When deemed necessary by the COR, the contractor shall provide emergency service after normal working hours or on weekends in extreme emergency cases or when the area involved needs to be unoccupied. All preparation will be coordinated between the COR and the on-site supervisor.

3.4.4 Research Laboratories in Foreign Countries

a. Required service other than scheduled annual certifications

b. Certification for new equipment or facilities which are of an urgent nature

c. Emergency requests shall be responded to, on-site, within fifteen (15) working days after receipt of request

d. The contractor will be reimbursed for travel costs (transportation, food and lodging) by the Government at Government per diem rates. The contractor shall schedule flights that will be as cost effective as possible for the Government. All receipts regarding travel, i.e., copy of plane ticket, taxis, parking, hotel and other transportation shall accompany the invoice for the month the trip was made. The cost for performing the required tasks on each piece of equipment shall be the same as the NIH Baltimore/Washington cost.

3.5. Location of Services

Services required by this contract shall primarily be performed on the NIH campus in Bethesda, Maryland. Other facilities that will be covered include: the NIH Animal Center, Poolesville, Maryland; the National Institute of Aging, Gerontology Research Center, Baltimore, Maryland; and other NIH owned, and leased facilities located in the suburban Maryland metropolitan area. Work will also be performed at the Rocky Mountain Laboratory in Hamilton, Montana, and the Integrated Research Facility, at Fort Detrick in Frederick, Maryland.

Approximately 60% of the estimated work under this contract will be at the NIH Bethesda, Maryland location; 10% at other facilities in the Baltimore/Washington area; and 15% at the Rocky Mountain facility, and 15% at the Integrated Research Facility.

4. Work Manner and Time

4.1. Manner and Time to Perform Services

The offeror shall provide on-site supervision to accomplish coordination and continuity of regular and emergency services and assignment of new work received from the COR.

The offeror shall be responsible for scheduling annual certification and emergency work with the principal user with coordination through the COR regarding these services. The offeror shall determine whether decontamination of equipment is necessary prior to commencement of work. The contractor will be informed by the COR as to under what circumstances equipment shall be routinely decontaminated prior to certification.

The contractor’s on-site supervisor shall be responsible for daily coordination with the COR to receive new work assignments, such as new equipment to be certified and rooms or equipment to be decontaminated. Any service required other than the annual certification shall be considered emergency service. The priority given to these emergency service assignments shall be as follows: First priority will be assigned to activities involving patient care in the NIH Clinical Center; second priority will be assigned to activities involving BSL 4 facilities; third priority will be assigned to activities involving BSL 3 facilities; fourth priority will be assigned to activities involving the animal program; and all others will be determined by the order in which they are requested. Deviation from this order or priority given to new work can be determined only by the COR.

4.1.1. Contractor’s Service Report

Copies of the Contractor’s Service Report of the previous day’s work shall be given to the COR on a daily basis or as the work is completed. Unless otherwise instructed by the COR, site specific (NIH Main Campus, Rocky Mountain Laboratory, and Frederick Integrated Research Facility), hard copies of all reports shall be maintained on site by the contractor and available for review.

4.1.2. Work Hours

Services shall be performed during normal working hours, 7:30 a.m. to 5:00 p.m. Monday through Friday, local time, excluding Federal holidays, except as specifically approved by the COR. The on-site supervisor hours of service shall be from 8:30 a.m. to 5:00 p.m.

4.1.3. Monthly Meeting

The contractor shall conduct a monthly meeting with the COR, no later than the 15th of the following month, in which the contractor shall provide a short-written explanation of overdue equipment cited in the comments section of the Contractor’s Service Report. Documentation to back-up the explanations shall be available to the COR upon request. With the exception of the first month of the contract, the contractor shall produce two (2) lists:

- List of equipment which was due to be certified the previous month with last date of previous certification

- List of equipment which is to be certified for the current month with last date of certification

4.1.4. Safety Precautions and Compliance

The contractor shall comply with the appropriate laboratory practices described in the following documents:

- Biosafety in Microbiological and Biomedical Laboratories, 5th edition, CDC-NIH, December 2009 (or most current edition)

- NIH Chemical Hygiene Plan, 2018 (or most current edition)

The contractor shall observe the necessary safety precautions throughout the performance of this contract. At a minimum, the contractor shall provide his personnel with clean outer garments, such as lab coats or overalls, to be worn while performing duties. Any additional personal protective equipment required for the safe performance of work shall be determined and provided by the contractor.

5. Reports

5.1. Daily Service Reports

Service Reports shall be furnished by the contractor and bear the NIH/DOHS logo (logo to be provided by NIH). The format and content of the report may be changed by the contractor during the course of the contract with the approval of the COR.

5.1.1. HEPA Filtered Service Reports

The service reports shall include all pertinent information regarding certification/repair of equipment. The reports shall also include, but not be limited to the following:

- Decontamination of Biological Safety Cabinets

- Initial Velocity Readings

- Pressure Leak Tests

- Leveling of Cabinets

- NIH Inventory Number, manufacturer, manufacturer Serial Number, building and room number, telephone number of user, name of laboratory and Institute

- Record of all repair work and parts replacement accomplished including labor hours

- Dates of Service

5.1.2. Chemical Fume Hood and Local Exhaust System Service Reports

The contractor shall utilize forms provided by the COR for Chemical Fume Hood and local Exhaust System Service Reports or the contractor may provide his own Chemical Fume Hood Report with the required information. These reports shall be delivered to the COR the workday following certification.

5.1.3 Pharmacy and Designated Drug Preparation Areas Service Reports

For NIH Pharmacies and designated drug preparation areas, at completion of daily work a hard copy of results (certifications/repairs) are to be left with the individual Pharmacy areas representative. Within five days of completion of work on an individual piece of equipment in the Pharmacy areas, a hard copy of the reports that has been reviewed and signed by the contractor on-site supervisor or their designate, is to be delivered to the Pharmacy facility.

5.2. Monthly Data Entry Work Summary and Status Reports

All required data for services shall be entered in the NIH CERTS Primary Barrier Equipment database by the contractor and a hard copy of the Monthly Data Entry Work Summary and Status Report provided to the COR. Access to the CERTS database system and training on the CERTS system will be provided at contract award.

6. Staffing

6.1 Qualified Personnel

The contractor shall provide full-time service personnel who have had training and experience in the maintenance, certification, and decontamination of the types of equipment and facilities as described herein. Resumes for all staff to be assigned to the contract shall be provided which reflect education, background, experience, certifications and specific scientific or technical accomplishments. special emphasis will be placed on demonstrated experience and knowledge performing the same type of services specified in the Statement of Work at Biosafety Level (BSL) 3, Animal Biosafety Level (ABSL) 3, ABSL 4, and BSL 4 facilities. Any requests for substitution or replacement of key personnel or changes in duties from those cited in the contractor’s original proposal shall be submitted in writing to the COR for approval. Approval by the COR shall be required for any request for substitutions or replacement of personnel or changes in duties throughout the duration of the contract. All personnel assigned to the Bethesda Washington/Baltimore, Rocky Mountain Laboratory and Frederick Integrated Research Facility shall be 100% dedicated to the NIH contract.

The contractor shall provide a full-time, on-site supervisor for the NIH Bethesda Washington/Baltimore area locations. The supervisor shall be an NSF Accredited Biohazard Cabinet Field Certifier and any temporary or permanent substitution for the on-site supervisor shall meet the same requirement and shall require the approval of the COR. The on-site supervisor must have demonstrated knowledge and experience working with clinical and biomedical research facilities with laboratories and animal care and use areas up to and including BSL 3 and ABSL 3. Demonstrated knowledge and experience working with biomedical research facilities with laboratories at ABSL 4 and BSL 4 would be a plus but is not required for this position.

The contractor shall provide a full-time on-site supervisor for the Rocky Mountain Laboratory located in Hamilton, MT. The supervisor shall be an NSF Accredited Biohazard Cabinet Field Certifier and any temporary or permanent substitution for the on-site supervisor shall meet the same requirement and shall require the approval of the COR. The on-site supervisor must have demonstrated knowledge and experience working with biomedical research facilities with laboratories and animal handling areas up to and including BSL 3, ABSL 3, BSL 4 and ABSL 4. In addition to the on-site supervisor, the contractor shall provide a full-time technician for the Rocky Mountain Laboratory who has had training and experience in the maintenance, certification, and decontamination of the types of equipment and facilities as described herein. Identification of additional backup personnel is a plus.

The contractor shall provide a full-time, on-site supervisor for the Frederick Integrated Research Facility. The supervisor shall be an NSF Accredited Biohazard Cabinet Field Certifier and any temporary or permanent substitution for the on-site supervisor shall meet the same requirement and shall require the approval of the COR. The on-site supervisor must have demonstrated knowledge and experience working with biomedical research facilities with laboratories and animal handling areas up to and including BSL 3, ABSL 3, BSL 4 and ABSL 4. In addition to the on-site supervisor, the contractor shall provide a full-time technician for the Frederick Integrated Research Facility who has had training and experience in the maintenance, certification, and decontamination of the types of equipment and facilities as described herein. Identification of additional backup personnel is a plus.

6.2 Key personnel

Key personnel for the contract are contract program manager, and all on-site supervisors. All key personnel assigned to the Bethesda Washington/Baltimore, Rocky Mountain Laboratory and Frederick Integrated Research Facility shall be 100% dedicated to the NIH contract.

6.3 Mandatory Training

All contractors and subcontractors enrolled in the NIH Biological Surety Program and/or NIH Select Agent Program must complete initial training based on the areas in which they will be accessing and annual refresher training thereafter.

All Key Personnel assigned to the Bethesda Washington/Baltimore, Rocky Mountain Laboratory and Frederick Integrated Research Facility must be able to meet the requirements described in the following Document:

NIH Biological Surety Program (APR 2017) www.ors.od.nih.gov/sr/dohs/safety/Pages/publications.aspx

6.4 NIH Information and Physical Access Security.

1. Baseline Security Requirements

0. Applicability. The requirements herein apply whether the entire contract or order (hereafter “contract”), or portion thereof, includes either or both of the following:

0. Access (Physical or Logical) to Government Information: A Contractor (and/or any subcontractor) employee will have or will be given the ability to have, routine physical (entry) or logical (electronic) access to government information.

0. Operate a Federal System Containing Information: A Contractor (and/or any subcontractor) will operate a federal system and information technology containing data that supports the HHS mission. In addition to the Federal Acquisition Regulation (FAR) Subpart 2.1 definition of “information technology” (IT), the term as used in this section includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources.

0. Safeguarding Information and Information Systems. In accordance with the Federal Information Processing Standards Publication (FIPS)199, Standards for Security Categorization of Federal Information and Information Systems, the Contractor (and/or any subcontractor) shall:

1. Protect government information and information systems in order to ensure:

0. Confidentiality, which means preserving authorized restrictions on access and disclosure, based on the security terms found in this contract, including means for protecting personal privacy and proprietary information;

0. Integrity, which means guarding against improper information modification or destruction, and ensuring information non-repudiation and authenticity; and

0. Availability, which means ensuring timely and reliable access to and use of information.

1. Provide security for any Contractor systems, and information contained therein, connected to an HHS network or operated by the Contractor on behalf of HHS regardless of location. In addition, if new or unanticipated threats or hazards are discovered by either the agency or contractor, or if existing safeguards have ceased to function, the discoverer shall immediately, within one (1) hour or less, bring the situation to the attention of the other party.

1. Adopt and implement the policies, procedures, controls, and standards required by the HHS Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain the HHS Information Security Program security requirements, outlined in the HHS Information Security and Privacy Policy (IS2P), by contacting the CO/COR or emailing fisma@hhs.gov.

1. Comply with the Privacy Act requirements and tailor FAR clauses as needed.

0. Information Security Categorization. In accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories, Appendix C, and based on information provided by the ISSO, CISO, or other security representative, the risk level for each Security Objective and the Overall Risk Level, which is the highest watermark of the three factors (Confidentiality, Integrity, and Availability) of the information or information system are the following:

Based on information provided by the ISSO, Privacy Office, system/data owner, or other security or privacy representative, it has been determined that this solicitation/contract involves:

[ ] No PII [X] Yes PII

Personally, Identifiable Information (PII). Per the Office of Management and Budget (OMB) Circular A-130, “PII is information that can be used to distinguish or trace an individual's identity, either alone or when combined with other information that is linked or linkable to a specific individual.” Examples of PII include, but are not limited to the following: social security number, date and place of birth, mother‘s maiden name, biometric records, etc.

PII Confidentiality Impact Level has been determined to be: [X] Low [ ] Moderate [ ] High

0. Protection of Sensitive Information. For security purposes, information is or may be sensitive because it requires security to protect its confidentiality, integrity, and/or availability. The Contractor (and/or any subcontractor) shall protect all government information that is or may be sensitive in accordance with OMB Memorandum M-06-16, Protection of Sensitive Agency Information by securing it with a FIPS 140-2 validated solution.

0. Confidentiality and Non-disclosure of Information. Any information provided to the contractor (and/or any subcontractor) by HHS or collected by the contractor on behalf of HHS shall be used only for the purpose of carrying out the provisions of this contract and shall not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government records and shall ensure that all work performed by its employees and subcontractors shall be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any HHS records may be made available or disclosed shall be notified in writing by the Contractor that information disclosed to such employee or subcontractor can be used only for that purpose and to the extent authorized herein.

The confidentiality, integrity, and availability of such information shall be protected in accordance with HHS and NIH policies. Unauthorized disclosure of information will be subject to the HHS/NIH sanction policies and/or governed by the following laws and regulations:

1. 18 U.S.C. 641 (Criminal Code: Public Money, Property or Records);

1. 18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information); and

1. 44 U.S.C. Chapter 35, Subchapter I (Paperwork Reduction Act).

0. Internet Protocol Version 6 (IPv6). All procurements using Internet Protocol shall comply with OMB Memorandum M-05-22, Transition Planning for Internet Protocol Version 6 (IPv6). .

0. Government Websites. All new and existing public-facing government websites must be securely configured with Hypertext Transfer Protocol Secure (HTTPS) using the most recent version of Transport Layer Security (TLS). In addition, HTTPS shall enable HTTP Strict Transport Security (HSTS) to instruct compliant browsers to assume HTTPS at all times to reduce the number of insecure redirects and protect against attacks that attempt to downgrade connections to plain HTTP. For internal-facing websites, the HTTPS is not required, but it is highly recommended.

0. Contract Documentation. The Contractor shall use provided templates, policies, forms and other agency documents to comply with contract deliverables as appropriate.

0. Standard for Encryption. The Contractor (and/or any subcontractor) shall:

8. Comply with the HHS Standard for Encryption of Computing Devices and Information to prevent unauthorized access to government information.

8. Encrypt all sensitive federal data and information (i.e., PII, protected health information [PHI], proprietary information, etc.) in transit (i.e., email, network connections, etc.) and at rest (i.e., servers, storage devices, mobile devices, backup media, etc.) with FIPS 140-2 validated encryption solution.

8. Secure all devices (i.e.: desktops, laptops, mobile devices, etc.) that store and process government information and ensure devices meet HHS and NIH-specific…