Revised_Final_RFP_A13_v1.docx

NBACC FFRDC RFP—Attachment 13

LISTING OF APPLICABLE DIRECTIVES

FOR A

National Biodefense Analysis and Countermeasures Center Operating Contract, a Federally Funded Research and Development Center

For

The Department of Homeland Security

Attachment 13, Section J

NBACC/FFRDC—APPLICABLE PUBLICATIONS AND FORMS

1.0 GENERAL:

A not all inclusive listing of Publications Laws and Directives and forms are listed below. The Directives and publications contain other references and requirements within. The publications and forms that are listed have been coded as mandatory (M) or advisory (A). The Contractor is obligated to follow those publications and use those forms coded as mandatory to the extent specified in other sections of this Statement of Work. After Contract Award all Federal, State, Local, Department of Homeland Security, Department of Defense, and U.S. Army regulations that apply to the Services required by the NBACC/FFRDC operation shall be complied with. The Contractor shall be guided by those publications or use those forms coded advisory to the extent necessary to accomplish the contract requirements. At the start of the contract, the Contractor shall obtain all the necessary and required publications and forms listed from the DHS/S&T Contracting Officer’s Representative, the Government Data Center or the web sites listed below. It shall be the Contractor's responsibility to establish follow-on requirements for supplements or amendments to listed publications that may be issued during the life of the contract. The Contractor may establish a publications account at the US Army http://www.usapa.army.mil/ Publishing Directorate. The Contractor shall immediately implement changes to mandatory publications. The Contractor shall advise the Contracting Officer of any change that will cause an increase in contract cost, prior to implementation. Baseline services shall be performed using existing DHS and Army COR approved Standard Operating Procedures (SOPs) along with other directives cited in this part. The Contractor shall review all SOPs within the first 90 days of performance and shall be provided an opportunity to re-write and re-publish existing SOPs to meet the Contractor’s methods, procedures and policy of performance. All rewritten SOPs must comply with all mandatory laws and directives and are subject to Approval by the DHS/S&T COR, the Government PM and the DHS Procuring Contracting Officer (PCO).

1.1 ANIMAL CARE AND USE LAWS AND REGULATIONS:

All animal husbandry services shall be carried out in strict accordance with the laws and regulations set out in this Attachment 5. No deviation may be made from those directives listed as “Mandatory” without approved waivers as may be obtained under the directives. The animal care SOPs that are required to be written by the NBACC FFRDC Contractor shall be drafted and provided to the Chief COR for review, comment and return for publication prior to the time the NBACC FFRDC is required to establish an animal holding and husbandry program within the new NBACC facility.

1.2 OBTAINING FULL TEXT COPIES OF PUBLICATIONS, DIRECTIVES, MANUALS, GUIDES AND SOPS INCLUDED, INCORPORATED OR REFERENCED IN THIS CONTRACT:

The contract incorporates several of the above-cited writings by reference. These documents are included by reference with the same force and effect as if they were given in full text. Upon request, the COR or Contracting Officer will make the full texts available, provide a media disc with the data or advise the contractor where the document is available on line. Good sites for electronic access are these addresses:

· www.arnet.gov

· www.usapa.army.mil.

1.3 ARMY AND DHS PUBLICATIONS AND BLANK FORMS:

The Contractor will use the Internet addresses included in the RFP for obtaining U.S. Government, DHS and Army Regulations, Forms and Directives. Any item not available in the net/on line site will be provided by the COR as requested or the contractor will be informed where the item is available.

1.4 COMMERCIAL PUBLICATIONS:

Procurement of commercial publications, necessary for performance on this contract, shall be the responsibility of the Contractor.

1.5 REGULATIONS

http://www.defenselink.mil/dodgc/defense_ethics/ethics_regulation/

http://www.nal.usda.gov/awic/legislat/21cfr97.htm

M

http://www.dtic.mil/whs/directives/corres/html/302037.htm

http://www.dtic.mil/whs/directives/corres/html/32162.htm

http://www.nap.edu/catalog/4988.html

http://www.aaalac.org/resources/theguide.cfm

http://www.usda.gov/wps/portal/usdahome http://www.ccac.ca/

M

M

http://www.researchtraining.org/referencedocuments/animalrefs/iacuc/AVMA%20Panel%202000%20Report.pdf

M

http://www.aalas.org/

A

http://www.osha.gov/

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M

M

May 2005 M

May 2005 M

M

M

(42 USC 241)

http://www.fda.gov/opacom/laws/phsvcact/sec241.htm

(42 USC 283e) http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=browse_usc&docid=Cite:+42USC283e

(21 CFR 56)

http://www.unmc.edu/irb/source_documents/21CFR56.htm

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a. Biosafety Program (Safety Program Manual

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b. Bloodborne Pathogens Program/Exposure Control Plan (Safety Program Manual)

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c. Chemical Hygiene Program (Safety Program Manual)

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d. Hazard Communication (HAZCOM) Program (Safety Program Manual)

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e. Respiratory Protection Program (Safety Program Manual)

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i. Primary Containment for Biohazards: Selection, Installation, and Use of Biological Safety Cabinets, 2nd Ediation, U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention and National Institutes of Health.

http://www.cdc.gov/od/ohs/pdffiles/BSC-3.pdf

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ii. Biosafety in Microbiological and Biomedical Laboratories (BMBL), NIH/CDC (available on-line:

http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm

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iii. OSHA Occupational Exposure to Bloodborne Pathogens Standard Title 29 CFR Part 1910.1030. http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10051

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iv. Possession, Use, and Transfer of Select Agents and Toxins; Final Rule 42 CFR 73 http://www.cdc.gov/od/sap/pdfs/42_cfr_73_final_rule.pdf

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v. Agricultural Bioterrorism Protection Act of 2002;

Possession, Use, and Transfer of Biological Agents and Toxins; Final Rule 7 CFR Part 331 and 9 CFR Part 121 http://www.aphis.usda.gov/programs/ag_selectagent/index.html

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vi. USAMRIID Regulation 385-9, Biosafety Level 2 Operations http://chembioeis.detrick.army.mil/docs/final/section2.pdf

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vii. USAMRIID Regulation 385-69, Biocontainment Laboratory Operations

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viii. DHS Management Directives, “Biosafety” “Care and Use of Animals” and “Protection of Human Subjects” (when promulgated).

M

M

a. Possession, Use, and Transfer of Select Agents and Toxins; Final Rule 42, CFR 73 http://www.cdc.gov/od/sap/pdfs/42_cfr_73_final_rule.pdf

M

b. Agricultural Bioterrorism Protection Act of 2002; Possession, Use, and Transfer of Biological Agents and Toxins; Final Rule 7 CFR Part 331 and 9 CFR Part 121.

M

c. U.S. Department of Health and Human Services, Centers for Disease Control and Prevention (CDC) Publication 93-8395, “Biosafety in Microbiological and Biomedical Laboratories (BMBL) http://www.cdc.gov/od/ohs/pdffiles/4th BMBL.pdf

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d. Department of Defense (DoD) Directive 5210.88, Safeguarding Select Agents and Toxins http://www.dtic.mil/whs/directives/corres/pdf/d521088_021104/d521088p.pdf

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e. DoD Directive 5210.88, Safeguarding Biological Select Agents and Toxins

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f. DoD Instruction 5210-xx, Minimum Security Standards for Safeguarding Biological Select Agents and Toxins (draft)

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g. Headquarters, Department of the Army (HQ, DA) Interim Guidance Measure #1, Establishing the Army Biological Surety Program

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h. HQ, DA Interim Guidance Measure #2, Establishing the Army Biological Personnel Reliability Program

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i. U.S. Army (USA) Regulation 600-85, Alcohol and Drug Abuse Prevention and Control Program http://www.usapa.army.mil/pdffiles/r600_85.pdf

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j. USA Regulation 525-13, Antiterrorism http://www.fas.org/irp/doddir/army/usfk525-13.htm

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k. USA Regulation 50-X, Army Biosurety Program (draft)

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l. USA Regulation 190-X, Army Military Police Biological Agent Security Program (draft) http://www.usapa.army.mil/pdffiles/r190_9.pdf

M

m. USAMRIID SOP SO-05-01, Escort of Non-Approved Personnel into BSL-3 and BSL-4 Biocontainment Laboratories and Selected BSL-2 Laboratories

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n. USAMRIID SO-01-03, Access Determinations During In-Processing

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o. USAMRIID Regulation 190-10, Security, Command Physical Security Plan

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p. USAMRIDD Regulation 385-70, Emergency Preparedness Plan

M

q. USAMRIID Regulation 500-10, Emergency Management Plan

M

r. DHS Management Directives on Select Agent and Toxin Security (upon entry into force)

M

s. Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Public Law 107-188;

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t. The Biological Weapons Anti-Terrorism Act of 1989, Public Law 101-298 of May 22, 1990

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u. The USA Patriot Act of 2001, Public Law 107-56, Section 817

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a. Environmental Protection Agency (EPA) 40 CFR Part 261—Identification and Listing of Hazardous Waste http://www.epa.gov/epaoswer/other/mineral/100285.pdf

M

b. Maryland Occupational Safety and Health http://www.dllr.state.md.us/labor/mosh.html.

M

c. American Conference of Governmental Industrial Hygienists (ACGIH) TLVs and BEIs (2002) http://www.acgih.org/home.htm

M

d. American Industrial Hygiene Association ANSI/AIHA Z9.5-1992-American National Standard for Laboratory Ventilation http://www.aiha.org/ANSICommittees/html/z9minutesmay98.htm

M

e. American National Standards Institute Z358.1-1998—Emergency Eyewash and Shower Equipment http://public.ansi.org/ansionline/Documents/Standards Activities/American National Standards/Procedures, Guides, and Forms/ANS Procedures - Historical/ANSIPRO1998.pdf

M

f. American National Standards Institute Z87.1-1999—American National Standard Practice for Occupational and Educational Eye and Face Protection http://public.ansi.org/ansionline/Documents/News and Publications/Brochures/1999 Annual Report.pdf

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g. American Society of Heating, Refrigerating, and Air Conditioning Engineers, Inc.: ASHRAE 62.1-2013-Ventilation for Acceptable Indoor Air Quality https://www.ashrae.org/standards-research--technology/standards--guidelines

M

h. Code of Maryland Regulations 9.12.33—Access to Information about Hazardous and Toxic Guidelines http://www.dsd.state.md.us/comar/idq_files/search.idq

M

i. Occupational Safety and Health Administration Standard 29 CFR 1904—Occupational Injuries and Illnesses Recording and Reporting http://www.osha.gov/pls/oshaweb/owastand.display_standard_group?p_toc_level=1&p_part_number=1904

M

j. Occupational Safety and Health Administration Standard 29 CFR 1910.132—Personal Protective Equipment, General Requirements http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=9777

M

k. Occupational Safety and Health Administration Standard 29 CFR 1910.133—Personal Protective Equipment, Eye and Face Protection http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=9778

M

l. Occupational Safety and Health Administration Standard 29 CFR 1910.134—Personal Protective Equipment, Respiratory Protection http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=12716

M

m. Occupational Safety and Health Administration Standard 29 CFR 1910.138—Personal Protective Equipment, Hand Protection http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=9788

M

n. Occupational Safety and Health Administration Standard 29 CFR 1910.151—Medical Services and First-Aid http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=9806

M

o. Occupational Safety and Health Administration Standard 29 CFR 1910.1000, Air Contaminants http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=9991

M

p. Occupational Safety and Health Administration Standard 29 CFR 1910.1020—Access to Employee Exposure and Medical Records http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10027

M

q. Occupational Safety and Health Administration Standard 29 CFR 1910.1200—Hazard Communication http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10099

M

r. Occupational Safety and Health Administration Standard 29 CFR 1910.1450—Occupational Exposure to Hazardous Chemicals in Laboratories http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10106

M

s. Occupational Safety and Health Administration Standard 29 CFR 1910, Subpart Z—Toxic and Hazardous Substances;

http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10147

M

t. USAMRIID Regulation 385-15, Respiratory Protection Program

M

u. USAMRIID Regulation 385-29, HAZCOM

M

v. USAMRIID Regulation 385-30, Chemical Hygiene Program

M

w. USAMRIID SOP FC-02-01-00, Disposal of Chemicals and Empty Chemical Containers

M

x. U.S. Environmental Protection Agency Standard 40 CFR 260—Hazardous Waste Management System: General.

http://www.ehso.com/ehso.php?URL=http%3A%2F%2Fwww.access.gpo.gov/nara/cfr/waisidx_02/40cfr260_02.html

M

y. U.S. Environmental Protection Agency Standard 40 CFR 261—Identification and Listing of Hazardous Waste.

http://www.access.gpo.gov/nara/cfr/waisidx_03/40cfr260_03.html

M

The following regulatory agencies govern the proper packaging and shipment of biological materials:

M

i. Public Health Service 42 CFR Part 72. Interstate Shipment of Etiologic Agents. A copy of the current regulation may be obtained from the Internet at http://www.cdc.gov/od/ohs

M

ii. Department of Transportation. 49 CFR Parts 171-178 Hazardous Materials Regulations http://www.cdc.gov/od/ohs/pdffiles/DOTHazMat8-14-02.pdf

M

iii. United States Postal Service. 39 CFR Part 111. Mailability of Etiologic Agents. Codified in the Domestic Mail Manual 124.38: Etiologic Agent Preparations.

http://www.access.gpo.gov.

M

iv. Occupational Health and Safety Administration (OSHA) 29 CFR Part 1910.1030. Occupational Exposure to Bloodborne Pathogens http://www.osha.gov

M

v. Dangerous Goods Regulations (DGR). International Air Transport Association (IATA) http://www.iata.org or http://www.who.org

M

M

i. Importation of Etiologic Agents of Human Disease. 42 CFR Part 71 Foreign Quarantine. Part 71.54 Etiologic Agents, Hosts, and Vectors http://www.washingtonwatchdog.org/documents/cfr/title42/part71.html

M

ii. Importation of Etiologic Agents of Livestock, Poultry, and Other Animal Diseases. 9 CFR Parts 92, 94, 95, 96, 122, and 130 http://www.access.gpo.gov/nara/cfr/waisidx_03/9cfrv1_03.html

M

iii. Importation of Plant Pests. 7 CFR Part 330. Federal Plant Pest Regulations; General; Plant Pests; Soil; Stone and Quarry Products; Garbage.

http://www.washingtonwatchdog.org/documents/cfr/title7/part330.html

M

iv. Transfer of Select Biological Agents of Human Disease. Possession, Use, and Transfer of Select Agents and Toxins; Final Rule 42 CFR 73; and Agricultural Bioterrorism Protection Act of 2002; Possession, Use, and Transfer of Biological Agents and Toxins; 7 CFR Part 331 and 9 CFR Part 121

M

v. Export of Etiologic Agents of Humans, Animals, Plants, and Related Materials. Department of Commerce. 15 CFR Parts 730 to 799.

http://www.washingtonwatchdog.org/documents/cfr/title15/index.html

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a. Occupational Safety and Health Administration Standard 29 CFR 1904.6 Recording and Reporting Occupational Injuries and Illnesses http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=9637

M

b. Occupational and Safety and Health Administration Standard 29 CFR 1910.1020—Access to Employee Exposure and Medical Records http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10027

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c. Occupational Safety and Health Administration Standard 29 CFR 1910.1030—Bloodborne Pathogen Standard http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10052

M

d. USAMRIID Regulation 385-16—Bloodborne Pathogens Exposure Control Plan

M

e. USMEPCOM Regulation 40-9—Bloodborne Pathogen Program http://www.mepcom.army.mil/pubs/pdf/regs/r-0040-009.pdf

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http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm

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http://www4.nationalacademies.org/news.nsf/isbn/0309089778?OpenDocument

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http://www.army.mil/usapa/epubs/pdf/r420_90.pdf

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http://www.dhs.gov/publication/management-directives-volume-0000-general-management-and-administration

2.0 BIO-THREAT CHARACTERIZATION PROGRAM (BTCP) RESEARCH CHARTERS/STANDARD OPERATING PROCEDURES (SOPS)/REQUIRED “M” DIRECTIVES:

2.1 Animal Care/IACUC:

a. BTCP IACUC Charter—Required to establish an animal care and use committee for review of all animal research

b. BTCP IACUC Policy and Guidelines Manual—Outlines the scope and the operations of the BTCP IACUC.

c. Standard Operating Procedures (SOPs)—SOPs that are necessary for operation of the animal facility. (To be drafted by the NBACC FFRDC, reviewed and approved by the DHS/S&T Contracting Officer’s Representative and placed in final form and implemented by the NBACC FFRDC Contractor at the new NBACC facility.)

The following table provides a listing of items that require the generation/maintenance of a Standard Operating Procedure that will be applied for the operation of the NBACC facility:

Standard Operating Procedure Topics:

Rodent Cage and Water Bottle Changes

Handling of Non-Human Primates

Procedures Following Exposure to Non-Human Primates

Non-Human Primate Psychological Well-Being Program Baseline

Husbandry Procedures for Indoor Housed NHP

Daily Feeding of Standard Diet to Non-Human Primates

Receipt of Non-Human Primates

Husbandry Procedures for Rabbits

Husbandry Procedures for Guinea Pigs

Husbandry Procedures for Conventional Rodents

Processing and Disposal of Dead Small Animals

Use of CO2 Rodent Euthanasia Chamber

Caring for Pinworm Positive Rodents

Feeding and Bedding Storage

Two Forcep Technique

Standard Operating Procedure Topics:

Requirements and Procedures for Facility Access Authorization

Receiving an Animal

SOP Review Process

Transport Requirements and Procedures

Procedures for Fasting Request

Requesting, Processing and Procuring Animals from Non-Approved Sources

Accident Reporting and Investigation Program

On-Call Personnel Schedule

Animal Census Procedures

Facility Drop Box

Generation of Cage Cards

Identification of Unidentified Cages

Processing Relocation/Ownership Transfer Request

SOP Training Program

Euthanasia Request

Request forms for CO2 Rodent Euthanasia Chamber

Animals Arriving From Outside Investigators

Receipt of Standard and Non-Standard Animal Orders

Preparation of Temporary Cage Cards

Overcrowded Animal Cages

Placing Animal Orders

Processing Animal Records

Processing Replacement Animal Orders

Removing Animals from Census

Reconciling Animal Orders

Animal Ordering Fees

Resident Murine (Mouse and Rat) Sentinel Placement and Identification Procedures

Procedures for Scheduled Testing of Resident Mouse and Rat Sentinel Rodents

Sentinel Soiled Bedding Procedures

Cage Changing - One Person

Facility Maintenance for Clean Quarantine

Standard Operating Procedure Topics:

Receipt/Removal of Samples in an ABSL-3/4 area

Training Requirements for Working in an ABSL-3/4

The Use of Fax and Phones in ABSL-3/4 Areas

Removing Dead Animals from ABSL-3/4 areas

Lockout/ Tagout Procedures

Verification of Temp and Relative Humidity

Operation and Maintenance of the Cage and Rack Washer

Operation of the Biosafety Cabinet

Operation of the Floor Scrubber

Manual Verification of Environmental Conditions in Facilities

Verification of Light Intensity

Monitoring and Control of Temperature, Humidity, Lighting, and Room Air Changes for Animal Rooms

Operation of Temperature and Humidity Indicator

Operation and Maintenance of Room Fogger

Working Safely in a Biological Safety Cabinet

Operation and Maintenance of the Room Fogger With Chlorine Dioxide

Personal Health and Safety

Procedures for Spills Clean-up

Sanitizing the Surgical Suite

Approved Chemicals

Handling Procedures for Potentially Infectious Medical Waste (PIMW)

Floor Sanitization Procedure

Detergents and Disinfectants

Sanitation of Procedure Room

Vermin Monitoring and Control

Chemical and Biological Monitoring of Facilities and Equipment

Waste Handling

Packaging and Autoclaving Items for Use in Animal Rooms

Room Sanitation Procedures

Verification of Sanitation

Methods for Providing Documentation of Sterility of Items After Autoclaving

Daily Health Checks and Room Monitoring

Standard Operating Procedure Topics:

Non-Human Primate Health Surveillance

Annual Health Surveillance of Covered Species

NHP Sampling Protocol Following Human Exposure

ACS Veterinary Protocol Review Process

Identifying Animals that have been Surgically Manipulated

Tail Clip Procedures

Retro Orbital Bleeding Procedures

Anal Tape Testing of Rodents

Fecal Sample Collection Procedures

Skin Scraping of Rodents

Animal Necropsy Procedures

Pathology Reports

Bone Marrow Smear Prep

Creation of Animal Medical Records

Husbandry Procedures for Indoor Housed NHP

Procedures for the Animal Kitchen and Food Storage

Login Procedures for Submitted Samples

Serum Extraction From Blood Sample

Storage Procedures for Blood Serum

Processing, Packing, and Shipping of Samples

Operation and Maintenance of the AO TS Meter

ADAMS Micro-Hematocrit Reader

Manually Determining Hematocrit

CRITOCAPS Micro-Hematocrit Capillary Tube Reader

Performing a Total Protein Measurement

Monitoring the Sanitation and Sterilizations Levels of Equipment and the Means by Which Results are Verified

Methods for Monitoring Salmonella, Shigella, and Yarsinia in NHP and the Means by Which Results are verified

Performing a HEMA-3

Preparing a Wedge- Type Blood Smear

Performing a Fecal Floation Procedure to Identify Parasitic Organisms

Performing an Anal Tape Examination for Pimworm Spp. in Rodents

Standard Operating Procedure Topics:

Performing Heartworm Antibody Tests

Performing an Ectoparasite Examination on a Hair Tape Sample

Laboratory Result Reporting Procedures

Fur Taping for Mites

Health and Safety Guidelines mandated for the Clinical Labs as Part

Animal Housing, Movement, and Transfer

Operation and Maintenance of the Dump Station

Procedures for Clean Cage Wash Area

Procedures for Soiled Cage Wash Area

Sanitizing the Surgical Suite

Ordering Supplies

Receiving Supplies

Ordering Animals

Weekends and Holiday Schedule

Operation of Autoclaves

Operation for L & A High Pressure Washing Machines

Ultrasonic cleaner tank

Operation for Large autoclaves

Roles and Responsibilities of the Quality Assurance Unit

Document Numbering System

Document Preparation and Control

Master Schedule

Controlled Document Issuance

Training Policy

Retention of Raw Data and Study Documentation

Issuance of Study Protocol

Preparation and Issuance of Final Study Report

Quality Assurance Unit Inspection and Audit Procedures

General Equipment Qualification Guidelines

Laboratory Deviation Reporting

Cage sanitation procedures

Reissue and use of controlled substances

Instruction regarding moribund or dead animals

Reissue and use of controlled substances

Tagging system for animals

Primate Quarantine or Isolation

Health Certificate Issuance

Surgical and Post-Surgical Protocol for Animals; ex rodents

Disposition of research animals

3.0 LABORATORY STANDARD OPERATING PROCEDURES (SOPs):

Standard Operating Procedure Topics:

Implementation and Responsibilities of the NHP Psychological Well-being Program

Documentation Procedures for the NHP Psychological Well-Being Program

Authorization for Access to Animal Care Services Facilities

Photographing and Videotaping Research Animals etc

Request for Visitor(s) and Minors to Observe Animal Research

Contacting Investigators for Animal Health Emergencies

Drug Ordering

Duplication of Cage Cards

Pathogen Control

Surcharges

Unidentified Animals or Cages of Animals

Animal Relocation

Animal Euthanasia Request by Investigators

Autoclave Testing/verification

Mission Statement-Abuse Policy

Procedure for handling animal care and use complaints

Biological Waste Disposal

Primate Enrichment Procedures-IACUC Guidelines

Laboratory SOPs are SOPs necessary to safely conduct in vivo and in vitro research within the BTCP facility. They include other operational guides for personnel and security. These SOPs and their contents are considered “M” directives at this time. The contractor shall be afforded a opportunity to rewrite the SOPs to conform to Contractors performance procedures within 90 days of award as set forth in the contract. Compliance with M directives and laws is required. Rewrite of SOPs is subject to coordination and approval by the DHS/S&T Contracting Officer’s Representative or DHS Contracting Officer. The following tables provide a listing of Laboratory SOP Topics:

a. QUALITY ASSURANCE SOP TOPICS:

Standard Operating Procedure Topics:

Quality Assurance Manual

Writer's Guide

Document Control

Acceptance of Work

Purchasing and Receipt

ID of Critical Items

Notebooks

Vendor Assessment

Customer Feedback & Satisfaction

Procedure Deviations

Nonconformance

Corrective Action

Preventive Action

Record Control

Customer Feedback & Satisfaction

Procedure Deviations

Nonconformance

Corrective Action

Preventive Action

Record Control

Internal Audit

Management Review

Customer Feedback & Satisfaction

Calibration

Method Validation

Accessioning Plan

Supply Inventory Control

Test Item Control - "Chain of Custody"

Continual Improvement

Casework Reporting

Electronic Data Control

Sample Testing Planning—“Analysis Plan”

Training

b. ADMINISTRATIVE/HUMAN RESOURCES:

Standard Operating Procedure Topic:

Orientation for BTCP Employees

c. SAFETY:

Standard Operating Procedure Topic:

Waste Disposal

Disinfectants

Laboratory Maintenance

Shipping

Biological Environmental Surveillance

Medical Surveillance

Contamination Control

PPE

Safety Inspections

Etiologic Agent Registration

Etiologic Agent Inventory

Biological Spills

Paraformaldehyde Decontamination

Chemicals

Incident Response and Reporting

Biohazard Protocol Registration

d. EQUIPMENT—OPERATIONS AND MAINTENANCE SOPS:

Standard Operating Procedure Topic:

Autoclave: O & M

BSC: O & M.

Incubator O & M

CFH: O&M

Class III BSC: O&M

Centrifuge O & M

Analytical Balances O & M

Equipment Maintenance Process

Calibration Process

Pipetting Device: O&M

Microscope: O&M

RPE: O&M

Microplate Washer: O&M

Microplate Reader: O&M

e. LABORATORY:

Standard Operating Procedure Topic:

Preparation of Bacillus Spores

Wet Mount for Spore Detection

Personnel Notification Procedures for Arrival of Casework

Chain of Custody

Sample Receipt

Security of Samples

Accessioning of Samples

Presumptive Identification of Bacillus anthracis by Gamma Phage Lysis Assay

Culture and Identification of Bacillus anthracis

Culture of Samples for Bacteria

Gram Staining Procedure

India Ink Staining

Enumeration of Cells and Spores

Preparation of BA Vegetative Cells for Molecular Controls

Handling and Use of Petri Dishes in NBFAC Laboratories

Preparation of Bacillus Spores

Sterility Testing

PCR for pX01 & pX02

Preparation of Sterile Distilled Water Dilution Blanks in NBFAC Laboratories

Verification of Decontamination by VHP

Detection of Viable B anthrasis Analysis Plan

Motility Assay Using Semi-Solid Agar in Tubes

f. SECURITY:

Standard Operating Procedure Topic:

Laboratory Access Request

Laboratory Escorting

Intrusion Detection System

Changing Cipher Codes

Key and Code Control

Laboratory Visitors

Security Incidents and Emergency Response

g. IBC—Policies and Charters are required for use of recombinant material within the NBACC facility.

1. BTCP IBC Charter

2. BTCP IBC Policy and Guideline Manual

3. SOPs

h. INSTITUTIONAL REVIEW BOARD (IRB)—Policies and Charters necessary for the use of human tissue or human subjects within the new facility. This would also include administration of IND drugs or vaccines, if protocol is sponsored by DHS.

1. BTCP IRB Charter

2. BTCP IRB Policy and Guideline Manual

3. SOPs

4.0 Background Information:

4.1 Safety and Security-Related Regulations and Guidelines Applicable to BTCP:

a. Bloodborne Pathogens:

· Occupational Safety and Health Administration Standard 29 CFR 1904.6- Recording and Reporting Occupational Injuries and Illnesses.

· Occupational Safety and Health Administration Standard 29 CFR 1910.1020- Access to Employee Exposure and Medical Records.

· Occupational Safety and Health Administration Standard 29 CFR 1910.1030- Bloodborne Pathogen Standard.

b. Animal Care/IACUC:

a. The Animal Welfare Act of 1966 (P.L. 89-544) and subsequent amendments, as promulgated in USDA regulations 9 CFR Chapter 1, Subchapter A, Animal Welfare. Parts 1, 2, and 3. USDA-APHIS-AC Unit 84, 4700 River Rd., Riverdale, MD 20737, 301/734-7833. www.aphis.usda.gov/ac/awa.html

b. AAALAC International Position Statements.

c. Biosafety in microbiological and biomedical laboratories.

DHHS Pub. No. (CDC) 93-8395, May 1999. Division of Safety, NIH, Bldg. 31, Rm. 1C02, Bethesda, MD 20892. 301/496-2801. www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm

d. d. Criteria for a recommended standard occupational exposure to waste anesthetic gases and vapors; DHEW Pub. No. (NIOSH) 77-140, March 1977.

e. www.cdc.gov/niosh/77-140.html

f. Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching. Federation of Animal Science Societies, First Revised Edition, January 1999. (Adopted January 1999) FASS, 111 North Dunlap Avenue, Savoy, IL 61987. 217/356-3182.

g. Guidelines for Animal Surgery in Research and Teaching, Am J Vet Res, 1993, 54:1544-1559. AVMA, 930 N. Meacham Rd., Schaumburg, IL 60196. 800/248-2862.

h. Guidelines for construction and equipment of hospital and medical facilities. AIA Press, 1993. AIA Press, 1735 New York Ave., NW, Washington, DC. 202/626-7332.

i. Guidelines for the Care and Use of Mammals in Neuroscience and Behavioral Research (NRC 2003). http://www.nap.edu/catalog/10732.html

j. Guidelines for the prevention and treatment of B Virus infection in exposed persons. Clinical Infectious Diseases, 1995, 20:421-439.

k. Guidelines for Research Involving Recombinant DNA Molecules April 1988 (63 FR 26018) as amended. http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html

l. Institutional Administrator's Manual for Laboratory Animal Care and Use. DHHS Pub., (NIH) No. 88-2959, 1988. Office of Laboratory Animal Welfare, National Institutes of Health, RKL I, Suite 360, MSC 7982, 6705 Rockledge Drive, Bethesda, MD 20892-7982. olaw@od.nih.gov

m. Institutional Animal Care and Use Committee Guidebook.

2nd Edition, 2002. Office of Laboratory Animal Welfares/Applied Research Ethics National Association. http://www.grants.nih.gov/grants/olaw/guidebook.pdf

n. Laboratory Animal Management: Rodents. 1996.

National Research Council. (Adopted September 1998) Laboratory Animal Management: Dogs. 1994. National Research Council. (Adopted September 1998) ILAR, 2101 Constitution Ave., MH 372. Washington, DC 20418. 202/334-2590. http://www.nap.edu/books/0309049369/html/index.html

o. Occupational Health and Safety Administration Standards 29 CFR 1910.1030 - Bloodborne pathogens. (Adopted September 1998) http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id=10051

p. Occupational Health and Safety Administration Standards 29 CFR 1910.1450 - Occupational exposure to hazardous chemicals in laboratories. (Adopted September 1998) http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id=10106

q. Occupational Health and Safety in the Care and Use of Research Animals 1997. National Research Council, National Academy of Sciences. (Adopted September 1997) National Academy Press, 2101 Constitution Ave., NW, Lockbox 285, Washington, DC 20055. 800/624-6242. http://www.nap.edu/catalog/4988.html

r. Public Health Service Policy on Humane Care and Use of Laboratory Animals. Reprinted 2000. Office of Laboratory Animal Welfare, National Institutes of Health, RKL I, Suite 1050, MSC 7982, 6705 Rockledge Drive, Bethesda, MD 20892-7982. http://grants.nih.gov/grants/olaw/references/phspol.htm

s. Report of the American College of Laboratory Animal Medicine on Adequate Veterinary Care in Research, Testing, and Teaching. 1996. (Adopted September 1996) ACLAM, 200 Summerwinds Drive, Cary, NC 27511. http://www.aclam.org/pub_adquate_care.html

t. Report of the AVMA Panel on Euthanasia; JAVMA, volume 218, no. 5, pages 669-696, March 1, 2001 (et seq.). AVMA, 930 N. Meacham Rd., Schaumburg, IL 60196. 800/248-2862. http://www.avma.org/resources/euthanasia.pdf

u. The Psychological Well-Being of Nonhuman Primates.

National Academy Press, Washington, DC, 1998. (Adopted January 1999) National Academy Press, 2101 Constitution Ave., NW, Lockbox 285, Washington, DC 20055. 800/624-6242. http://pompeii.nap.edu/books/0309052335/html/index.html

v. Health Research Extension Act, Section 495 (Animals in Research) (PL 99-158). PHS Policy on Humane Care and Use of Laboratory Animals as revised 1986 and the NIH Guide for the Care and Use of Laboratory Animals, revised 1985 (NIH Publication 86-23).

c. IRB

a. The Declaration of Helsinki (1964). Recommendations guiding physicians in clinical research adopted by the World Medical Assembly, amended 1975 and 1983. http://www.cirp.org/library/ethics/helsinki/.

b. Ethical Principles in the Conduct of Research with Human Participants (1973). Adopted by the American Psychological Association (APA), amended 1992. http://www.apa.org/ethics/code.html.

c. Code of Federal Regulations, Title 45 CFR Part 46, Final Regulations for the Protection of Human Research Participants. Revised June 18, 1991, as the "Common Rule," Federal Policy for the Protection of Human Subjects; Notices and Rules. http://www.gpoaccess.gov/cfr/index.html

d. The Belmont Report - Ethical Considerations and Principles for the Protection of Human Subjects of Research (April 18, 1979). Adopted by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. http://ohsr.od.nih.gov/guidelines/belmont.html

d. NBACC Accreditation Guidelines:

ISO 17025--International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC), 17025:1999, First Edition, General requirements for the competence of testing and calibration laboratories.

ACLD/LAB-International--American Society of Crime Laboratory Directors/Laboratory Accreditation Board, 6.001.Sr.2004 – Rev.0, March 2004, Supplemental Requirements for the Accreditation of Forensic Science Testing and Calibration Laboratories.

NBFAC (ISO 17025 applicable approved Standard Operating Procedures (SOP’s)):

Listing of Applicable SOPs are provided below:

Standard Operating Procedures:

Standard Operating Procedures:

e. Manuals:

i. Respiratory Protection Program (Safety Program Manual

5.0 ADDITIONAL U. S. ARMY DIRECTIVES:

http://www.army.mil/usapa/epubs/

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