RFQ_Section_J_-_Attachments_I_-_VII.pdf

NIHES201800011

ATTACHMENT I – IDIQ GENERAL STATEMENT OF WORK

LABORATORY ANIMAL DIAGNOSTIC TESTING SERVICES

NATIONAL INSTITUTES OF ENVIRONMENTAL HEALTH SCIENCES

RESEARCH TRIANGLE PARK, NC

1.0. BACKGROUND: The National Institute of Environmental Health Sciences (NIEHS), located in Research

Triangle Park, North Carolina, is one (1) of 27 research institutes and centers that comprise the National Institutes of

Health (NIH), U.S. Department of Health and Human Services (DHHS). The mission of the NIEHS is to discover how the environment affects people in order to promote healthier lives. The Branches & Laboratories at NIEHS fall under the Intramural Research and the National Toxicology Program (NTP) Divisions. The Comparative Medicine

Branch (CMB) ensures the judicious and humane use of rodents for biomedical research that benefits human and animal health. The CMB maintains the animal facility for the NIEHS and is responsible for the health and well-being of the research animal population. The health and well-being of these animals are a critical factor in many research projects. Laboratory animals are susceptible to many different diseases, which may be symptomatic or subclinical but still have profound effects on research. Some of these diseases can be zoonotic (contagious to humans). Diagnosis of these animal diseases is very important in maintaining the quality of the NIEHS research animals as well as ensuring the safety of the researcher and animal care staff. The Quality Assurance Laboratory

(QAL) within CMB is responsible for monitoring the health status of incoming and resident animal colonies and making appropriate decisions based on the results of this monitoring. The QAL is also responsible for the NIEHS animal health surveillance program. Sentinel animals are used most often monitor the animal population. Monitoring may include a complete necropsy, examination for ecto- and endoparasites, microbial identification, Polymerase

Chain Reaction (PCR) and analysis of rodent blood or serum for response of the immune system to pathogens

(serological assay). QAL is responsible for reporting the health status of the animal or tissue specimens back to the appropriate veterinarian(s) and researchers. The primary scope of the contract will be to perform diagnostic testing services as part of the animal health surveillance program. Identification of unknown bacterial or fungal isolates using Matrix Assisted Laser Desorption/Ionization – Time of Flight (MALDI-TOF) spectrophotometry or partial genomic sequencing of biological samples may also be requested. Other assays, such as Western Blot or

Immunofluorescent Antibody (IFA) may be requested to confirm initial, equivocal, serological results. As such, testing services of a commercial laboratory are needed to conduct the diagnostic testing on rodent blood/sera, rodent tissues, rodent fecal specimens or other biological samples (e.g., cell cultures, viral vectors, isolated proteins, etc.).

2.0. SCOPE: This Statement of Work (SOW) will be used to execute a broad range of laboratory animal diagnostic testing services under the resultant Multiple Award Indefinite Delivery, Indefinite Quantity (IDIQ) contract. During the contract period, the Government will identify tasks required to complete each specific project. Task orders with more specific details will be placed as needed by the NIEHS. Specific performance dates and quantities will be specified on each individual task order. This is a non-personal services contract. The Government will not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the contractor who, in turn is responsible to the Government. The

Contractor, in turn, shall be accountable to the Government for contractor personnel, subcontractors, or contract service providers.

3.0. OBJECTIVES: The basic service objective is to provide animal diagnostic testing services through a readily available source (laboratory) for diagnostic testing services as a part of the QAL overall diagnostic and health monitoring programs at NIEHS. The Contractor shall receive the biological samples, perform requested testing on these samples and shall provide results to the Government via e-mail, telephone or other electronic source (e.g., online access).

4.0. TASKS: The Contractor shall perform animal diagnostic testing services in accordance with standard laboratory practices using state of the art microbiological procedures. The number of tests requested per sample will depend upon species and the animal's history.

4.1. General Tasks:

(a) The Contractor’s lab shall be fully equipped to provide state-of-the-art serological testing, PCR assays, MALDI-TOF spectrophotometry and partial genomic sequencing prior to bidding on this contract. All equipment used in the testing procedures shall be maintained in good working order. Calibration of all devices and testing equipment shall be done with sufficient frequency as to ensure accurate results. No additional instrumentation shall be purchased with the contract funds.

(b) Contractor shall be capable of performing diagnostic testing services for all agents listed in the list of laboratory animal diagnostic tests and perform MALDI-TOF spectrophotometry and partial genomic sequencing of submitted biological sample for the purpose of microbe identification, in accordance with standard laboratory practices and state of the art microbiological procedures. The number of tests requested per sample will depend upon the nature of the individual sample.

(c) All work under this contract shall be monitored by the Contracting Officer Representative (COR) whose position is defined elsewhere in the contract.

(d) The Contractor shall provide submission forms and instructions for preparation and packaging of biological samples submitted for testing.

(e) The Government will prepare and package in all samples as instructed by the contractor.

(f) The Government will deliver the shipping container(s) to an acceptable overnight delivery service used by the Contractor.

(g) The shipping container(s) will be delivered to the Contractor by express overnight delivery service at the

Contractor’s own expense.

(h) Upon receipt of the samples, the Contractor shall log all sample information into a database at the

Contractor’s laboratory. The Contractor shall provide the Government with a web-based portal to confirm sample receipt.

(i) Results of all testing shall be recorded in a database at the Contractor’s Laboratory within the deadlines outlined below. The Contractor shall provide the Government with a web-based portal to access results.

(j) The Contractor shall also provide results in an electronic form to be delivered by email to the COR within the deadlines outlined below.

(k) The Contractor shall immediately notify the COR if sample results are delayed beyond the stated reporting timelines and provide an estimated completion time. Extensions to reporting requirements may only be granted by written consent (email acceptable) of the COR.

(l) The COR may also request that the questionable sample(s) be sent at the Contractor’s expense to another laboratory specified by the Government for confirmatory testing.

(m) In the event of a pathogen outbreak affecting the NIEHS research animal population, the Contractor shall be able to perform or assist in research to help elucidate the cause, pathogenesis, and epidemiology of the causative agent as requested by the COR.

(n) In the event of a disease outbreak in which a large number of samples may need to be tested for an individual agent, the Contractor shall provide NIEHS an additional price discount on the individual serology or PCR assay. The sample number range for the proposed discount will be included in the

Contract Pricing Matrix and any additional discounts shall be listed in the price quote at the task order level.

(o) After completion of the serological, PCR or genomic sequencing, the test samples (if sufficient quantity remains) shall be stored for six (6) months at -70°C. During this period, stored samples shall be returned to the COR (or authorized designee) if so requested. After six months, the samples may be discarded.

4.2. Serological Testing:

(a) The Contractor shall, as a minimum, be prepared to perform serological assays by appropriate methods such as Multiplex Fluorescent Immunoassay (MFIA), Immunofluorescent Antibody (IFA), Enzyme-Linked

Immunosorbent Assay (ELISA), or Hemagglutination Inhibition (HAI), as appropriate. IFA and/or Western

Blot methodology should also be available for confirmatory testing. Should new, more sensitive or efficient testing methodology become available or new pathogenic agents discovered during the course of this offering, it will be incorporated through modification of the Contract.

(b) The Contractor shall use the primary method of testing serological assays in their own laboratory as stated in their evaluated technical submission.

(c) If serological assays for new or emerging pathogens are made available by the Contractor during the contract period, testing for these agents can be performed under the contract and listed on reports and invoices under “Individual Serological Assay – (agent name)”. Billing shall also occur at the same rate as all other individual serological assays.

(d) Results of all serological tests shall be reported within 3 working days after receipt of the samples by the

Contractor.

4.3. Polymerase Chain Reaction (PCR) Assays:

(a) The Contractor shall be prepared to perform PCR assays for all agents listed in the list of laboratory animal diagnostic tests – “Individual PCR Assays”.

(b) The Contractor shall specify in their proposal if a particular assay is performed using traditional methods including gel electrophoresis for product visualization or fluorescent detection methods such as quantitative, real-time PCR (qRT-PCR).

(c) The Contractor shall clearly list in their proposal any PCR assays they are unable to perform in their own laboratory.

(d) The Contractor shall provide in their proposal the validated limit of detection (LOD) or limit of quantification (LOQ) for each agent tested.

(e) If PCR assays for new or emerging pathogens are made available by the Contractor during the contract period, testing for these agents can be performed under this contract and listed on reports and invoices under

“Individual PCR Assay – (agent name)” and billed at the same cost as all other individual PCR assays.

(f) Results of routine PCR tests shall be reported to the COR within 5 working days after receipt of samples by the Contractor.

(g) In the event of a pathogen outbreak, the COR may request expedited processing of specimens for PCR deemed critical by the COR. The COR will notify the Contractor regarding sample number and tests required prior to shipment. These samples shall be processed by the Contractor and resulting data transmitted to the COR within 3 working days.

4.4. Matrix Assisted Laser Desorption/Ionization – Time of Flight (MALDI-TOF) Spectrophotometry:

(c) The Contractor shall be prepared to perform MALDI-TOF spectrophotometry services for the purpose of identifying bacterial or fungal agents submitted by the Government.

(d) If the Contractor is unable to identify the bacterial or fungal agent at the Genus level via MALDI-TOF spectrophotometry, the Contractor shall perform partial genomic sequencing as described in the following section 6) Genomic Sequencing for the purpose of identification at no additional charge.

(e) Results of Matrix Assisted Laser Desorption/Ionization – Time of Flight (MALDI-TOF) spectrophotometry shall be reported to the COR within 5 working days after receipt of samples by the Contractor.

4.5. Partial Genomic Sequencing:

(a) The Contractor shall be prepared to perform partial genomic sequencing analysis of standard bacterial gene targets such as 16s rRNA, rpoB, or gyrA on submitted bacterial samples for the purpose of organism identification.

(b) The Contractor shall provide an electronic copy of the generated sequence if requested by the COR.

(c) Results of partial genomic sequencing analysis shall be reported within 15 working days after receipt of samples by the Contractor.

4.6. Other Procedural Requirements: In addition to the above, the Contractor shall provide the following:

(a) The Contractor shall provide a training program for employees involved with the contract. A copy of the training program shall be provided in the proposal and furnished to the COR when changes occur.

(b) The COR and/or an authorized representative may make an annual visit to the Contractor’s place of work at the Government’s expense to inspect and review all procedures covered in the contract. The COR shall tour the facility with a representative of the Contractor. The COR may observe all procedures mentioned in the contract while visiting the Contractor’s facility.

(c) In the event of a disease outbreak affecting the NIEHS research animal population, the Contractor shall be able to perform or assist in research to help elucidate the cause, pathogenesis, and epidemiology of the causative agent as requested by the COR.

(d) Site Visit: As part of Quality assurance, the COR and/or an authorized representative may make an annual visit to the Contractor’s place of work at the Government’s expense to inspect and review the serological testing and PCR procedures covered in the contract. The COR shall tour the facility with a representative of the Contractor. The COR may observe all of the procedures mentioned in the contract while visiting the

Contractor’s facility.

4.7. Deliverables: In addition to the required reports set forth elsewhere in the contract and in the deliverable schedule, the Contractor shall prepare and submit regular recurring Technical Reports. The Contractor shall describe information about the activities undertaken during the reporting period and shall provide information on planned activities for future reporting periods. The frequency and specific content of these reports shall be in accordance with deliveries/delivery schedules mentioned below.

(a) Monthly Reports: The Contractor shall provide the COR with a detailed description of the services provided during the previous calendar month. The monthly report will be sent within 10 working days of the end of the reporting period. At a minimum, these tabulated reports will include the following information.

Case or

Report #

Date

Received Service Provided Quantity Purchase Order #

Individual Serological Assay – (Agent Name)

Individual PCR Assay – (Agent Name)

Mouse Serology Panel 1, 2 or 3

Rat Serology Panel 1 or 2

Fecal PCR Panel

Environmental PCR Panel

Biological PCR Panel

MALDI-TOF Microbial ID

Sequence Analysis for Microbial ID

• Only specific services performed during the preceding month need to be listed on the monthly report.

• Under the “Services Provided” column, individual serological or PCR assays will be listed as separate line items. For example, if 10 samples were submitted for Mouse Parvovirus testing and 8 of those same samples were also tested for Mouse Norovirus, they would be listed as follows:

Case or

Report #

Date

Received Service Provided Quantity Purchase Order #

Individual Serological Assay - Mouse

Parvovirus

Individual Serological Assay - Mouse

Norovirus

• Under the “Services Provided” column, serological panels (e.g., Mouse 1, 2 or 3; Rat 1 or 2) will be listed as separate line items.

• Samples tested under an outbreak will include “(Outbreak)” in the services provided description after the agent name.

(b) Yearly Reports: The Contractor shall provide the COR with a detailed description of all services provided during the previous contract year (base and all options) and will be due within 30 days of the end of the contract year. At a minimum, these tabulated reports will include the following information.

Service Provided Total Quantity Purchase Order # Purchase Order $

Individual Serological Assay – (Agent Name)

Individual PCR Assay – (Agent Name)

Mouse Serology Panel 1, 2 or 3

Rat Serology Panel 1 or 2

Fecal PCR Panel

Environmental PCR Panel

Biological PCR Panel

MALDI-TOF Microbial ID

Sequence Analysis for Microbial ID

• Individual Serological and PCR Assays will be listed as separate line items for each agent tested.

• Only specific services performed will be listed.

(c) Final Report: A formal, comprehensive, final report, that can be understood by non-technical personnel shall be submitted on the last business day of the Period of Performance to the COR. The report shall include a summation of the results furnished to the CMB, NIEHS. The report shall include any problems in testing that were incurred during the contract, the number of positive samples detected for each agent. This report shall include all necessary tables, charts, drawings and data sheets. The report shall include, at a minimum:

a. Preface: Brief Introduction.

b. Acknowledgements: Name, title, and responsibilities of each key staff member on the project; of

Subcontractors and of consultants; as well as recognition of committee members; etc.

c. Project Summary: The text should include, but need not be limited to:

• The purpose of the project

• Background including discussion of issues and pertinent historical facts and other information essential to full understanding of the project

• Methodology designed and used, and its execution, including any major difficulties and their resolution

• Appropriate other aspects of the total contract efforts

• A summary of the salient results achieved during the performance period

• Conclusions

d. Recommendations, with supporting rationale, as appropriate to the Government and/or the private sector.

e. An assessment of the degree of success in achieving the goals of the project.

f. As it relates to Green requirements, the Contractor shall include details on their use of green purchasing in their task, process, packaging, marking, delivery, training, and environmentally preferable products.

g. Appendices.

5.0. KEY PERSONNEL: The following will be considered key personnel by the Government:

5.1. Project Supervisor. This individual shall be responsible for overseeing all aspects of this contract including serological and PCR testing, MALDI-TOF spectrophotometry, genomic sequence analysis, reporting and contract personnel.

• Educational requirements: This individual shall have a Ph.D. in microbiology, or DVM/VMD from an accredited school of veterinary medicine and be board certified by the American College of Laboratory

Animal Medicine (ACLAM).

• Experience: This individual shall have a minimum of five (5) years in laboratory rodent serology testing, PCR assays, MALDI-TOF spectrophotometry, and genomic sequencing.

5.2. Serology Laboratory Supervisor. This individual is responsible for supervision of personnel performing serological assays and will serve as the principle contact with the COR for serological assays.

• Educational requirement: This individual shall have a minimum of a Bachelor’s degree.

• Experience: This individual shall have a minimum of two (2) years supervisory experience in laboratory serology testing.

5.3. PCR Laboratory Supervisor. This individual is responsible for supervision of personnel performing PCR assays and partial genomic sequence analysis and will serve as the principle contact with the COR for PCR assays and sequencing.

• Educational requirement: This individual shall have a minimum of a Bachelor’s degree.

• Experience: This individual shall have a minimum of two (2) years supervisory experience in laboratory

PCR testing.

5.4. Spectrophotometry Laboratory Supervisor. This individual is responsible for supervision of personnel performing MALDI-TOF spectrophotometry testing and will serve as the principle contact with the COR for this testing.

• Educational requirement: This individual shall have a minimum of a Bachelor’s degree.

• Experience: This individual shall have a minimum of two (2) years supervisory experience in MALDI-TOF spectrophotometry.

5.5. Laboratory Technicians. These individuals shall be responsible for performing all testing.

• Educational requirement: Individuals must be a high school graduate and have completed a minimum of one year of college.

• Experience: These individuals must have a minimum of six months experience performing serologic or

PCR assays.

5.6. Billing Specialist. This individual shall be responsible for processing and transmittal of invoices to the COR for approval.

• Educational requirements: This individual must be a high school graduate.

• Experience: This individual shall have 6 months experience in word processing and spreadsheet or optional billing invoice preparation software.

6.0. COMPLIANCE (508 Compliance (36 CFR Part 1194 - Information and Communication Technology

Standards and Guidelines Compliance)): If deliverables includes features and functions in addition to those identified as requirements, these features and functions also need to conform to relevant Section 508 technical provisions, functional performance criteria, and information, documentation and support.

• Section 508 Information: http://www.section508.gov/

• Guide to the Section 508 Standards: https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards/guide-to-the-section-508-standards

• Making Files Accessible: http://www.hhs.gov/web/section-508/making-files-accessible/index.html

NOTE: If the deliverable includes features and functions in addition to those identified as requirements, these features and functions also need to conform to relevant Section 508 technical provisions, functional performance criteria, and information, documentation, and support.

7.0. QUALITY CONTROL: The Government is committed to a highly interactive relationship between quality control by the contractor and quality assurance by the government. This relationship shall be achieved through an effective prevention based quality control program dedicated to ensuring the best possible products and services to end users. As part of quality control, the Contractor shall submit a Quality Control Plan (QCP) which at a minimum shall include a self-inspection plan, an internal staffing plan, and an outline of the procedures that the contractor shall use to maintain quality, timeliness, responsiveness, customer satisfaction, and any other requirements set forth in this SOW. The QCP shall be updated five (5) days after contract award. The QCP shall document how the contractor intends on meeting and complying with the quality standards established in this SOW. The contractor’s

QCP shall be maintained throughout the life of the contract and shall include the contractor’s procedures to routinely evaluate the effectiveness of the plan to ensure the contractor is meeting the performance standards and requirements of the contract.

8.0. GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES: This section identifies those items such as property, information and/or services that will be provided for the contractor’s use (without cost to the contractor): N/A

9.0. CONTRACTOR FURNISHED ITEMS AND RESPONSIBILITIES: The Contractor shall furnish all supplies, equipment, and services required to perform work under this contract that are not listed under section 8 of this SOW.

• Training: The Contractor shall provide a training program for employees involved with the contract. A copy of the training program shall be furnished to the COR.

• Facilities & Equipment: The Contractor’s lab shall be fully equipped (laboratory and computer equipment) to perform serological testing and PCR assays prior to bidding on this contract. Equipment used in these http://www.section508.gov/ https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards/guide-to-the-section-508-standards https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards/guide-to-the-section-508-standards https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards/guide-to-the-section-508-standards http://www.hhs.gov/web/section-508/making-files-accessible/index.html testing procedures shall be maintained in good working order. Calibration of all devices and testing equipment shall be done with sufficient frequency as to ensure accurate results.

10.0. HOURS OF OPERATION: Normal business hours are Monday-Friday, excluding Federal holidays and core hours at NIEHS typically fall between: 8:00 am – 5:00 pm.

11.0. PLACE OF PERFORMANCE: Each delivery order will specify the specific delivery location.

12.0. PERIOD OF PERFORMANCE: The contract has a five (5) year ordering period. Individual task orders issued cannot exceed a 12-month period.

13.0. SAFETY AND HEALTH: The Contractor shall comply with all applicable USNRC, Federal, North Carolina

State, Occupational Safety and Health Administration (OSHA) standards and local laws and regulations concerning the environmental, occupational safety and health, and hazardous material. The contractor shall ensure employees have all required training and certifications related to OSHA requirements. The documentation shall be readily available for the Contracting Officer to review at any time during the life of the contract.

14.0. DATA RIGHTS: The Government has unlimited rights to all documents/material produced under this contract to the extent permitted by the data rights clauses. The parties mutually acknowledge their understanding that this is the government’s intent. All documents and materials produced under this task order shall be government owned and are the property of the government with all rights and privileges of ownership/copyright belonging exclusively to the government. These documents and materials may not be used or sold by the contractor without written permission from the contracting officer. All materials supplied to the Government will be the sole property of the government and may not be used for any other purpose. This right does not abrogate any other government rights.

ATTACHMENT II

DELIVERABLE SCHEDULE

Deliverable Frequency Medium/Format Submit To

Completed Test Results • Completed within days of sample receipt

- Serology – 3 days

- PCR – 5 days

- MALDI-TOF – 5 days

- Genomic Sequencing – 15 days

Electronically (email) COR

Monthly Reports Monthly Electronically (email) COR

Annual Reports Annually Electronically (email) COR

Final Report End of the Contract period Electronically (email) COR

Commercial Product Catalog Annually Electronically (email) COR

A List of Supervisory Personnel authorized to act on behalf of the Contractor with Contact Information

Contract start or as changes occur Electronically (email) COR

Training Program With proposal or as changes occur Electronically (email) COR

ATTACHMENT III

QUALITY ASSURANCE REQUIREMENT SUMMARY

Task Deliverable Performance Indicator Acceptable Quality Level Monitoring Method

Serological Testing Tests results on submitted samples

Processed and delivered by specified times

100% testing on rodent blood or sera

COR oversight and feedback from end user

PCR Testing Test results on submitted samples

Processed and delivered by specified times

100% testing on PCR Assays and Identification of Agents

COR oversight and feedback from end user

MALDI-TOF

Spectrophotometry

Test results on submitted samples

Processed and delivered by specified times

100% testing on MALDI-

TOF and Identification of

Agents

COR oversight and feedback from end user

Genomic Sequence

Identification of Agents

Test results on submitted samples

Processed and delivered by specified times

100% testing on genomic sequencing and Identification of Agents

COR oversight and feedback from end user

Timeliness in Delivery of

Testing Results

Telephonic, electronic and/or written tests results

Samples/items tested and delivered as requested

100% items tested and delivered

COR oversight, review, and acceptance – only minor edits required

Timeliness in Delivery of

Written Reports (Monthly, Yearly & Final)

a. Monthly Report

b. Yearly Report

c. Final Report

Accuracy of written report 100% accuracy of final written report

COR’s oversight, review and acceptance

ATTACHMENT IV

LIST OF LABORATORY ANIMAL DIAGNOSTIC TESTS

Individual Serological Assay Agent Abbreviation Species

Cilia Associated Respiratory Bacillus CARB M, R

Clostridium piliforme TYZ M, R

Ectromelia Virus ECTR M

Encephalitozoon cuniculi ECUN M, R

Hantaan Virus HANT M, R

Infectious Diarrhea of Infant Rats IDIR R

Kilham Rat Virus KRV R

Lactate Dehydrogenase-Elevating Virus LDEV (LDV) M

Lymphocytic Choriomeningitis Virus LCMV M, R

Minute Virus of Mice MVM (MMV) M

Mouse Adenovirus - Strain 1 MAD1 (FL) M

Mouse Adenovirus - Strain 2 MAD2 (K87) M

Mouse Cytomegalovirus MCMV M

Mouse Hepatitis Virus MHV M

Mouse Norovirus MNV M

Mouse Parvovirus MPV (1-5) M

Mouse Rotavirus (Enzootic Diarrhea of Infant Mice) MRV/EDIM M

Mouse Thymic Virus MTV (MTLV) M

Mycoplasma arthritidis M arthriditis M, R

Mycoplasma pulmonis M pulmonis M, R

Parvovirus NS-1 Protein NS-1 (Parvo) M, R

Pneumocystis carinii P carinii R

Pneumonia Virus of Mice PVM M, R

Pneumonitis Virus K Virus M

Polyoma Virus POL M

Rat Coronavirus RCA/SDAV R

Rat Cytomegalovirus RCMV R

Rat Minute Virus RMV R

Rat Parvovirus RPV R

Rat Polyomavirus 2 RPyV2 R

Rat Theilovirus RTV R

Reovirus (Type 3) REO3 M, R

Sendai Virus SEN M, R

Theiler's Encephalomyelitis Virus TMEV or GDVII M

Toolan's H-1 Virus H1 R

ATTACHMENT IV

LIST OF LABORATORY ANIMAL DIAGNOSTIC TESTS CONTINUED

Serological Panels Species Agents Included In Panels

Mouse Serology Panel 1

M

EDIM

MHV

MNV

MPV (1-5)

MVM

NS-1 (Parvo)

EDIM M pulmonis

PVM

REO3

SEND

TMEV

MHV

Mouse Serology Panel 2 M MNV

MPV (1-5)

MVM

NS-1 (Parvo)

EDIM M pulmonis

PVM

REO3

SEND

TMEV

CARB LDEV

MHV ECTR MAD1

Mouse Serology Panel 3 M MNV

MPV (1-5)

ECUN

HANT

MAD2

MCMV

MVM K Virus MTV

NS-1 (Parvo) LCMV POL

H-1 REO3

RMV

RPV

RTV

SEND

KRV

Rat Serology Panel 1 R M pulmonis

NS-1 (Parvo)

PVM

RCV/SDAV

H-1 REO3

RMV

RPV

RTV

SEND

CARB

ECUN

HANT

LCMV

P. carinii

KRV

Rat Serology Panel 2 R M pulmonis

NS-1 (Parvo)

RCV/SDAV

Individual PCR Assay Agent Abbreviation

Bordetella bronchiseptica B. bronchiseptica

Bordetella hinzii/pseudohinzii B. hinzii/pseudohinzii

Campylobacter spp. Campylobacter spp.

Cilia Associated Respiratory Bacillus CARB

Citrobacter rodentium C. rodentium

Clostridium piliforme C. piliforme

Clostridium perfringens C. perfringens

Corynebacterium bovis C. bovis

Corynebacterium kutscheri C. kutscheri

Cryptosporidium spp. Cryptosporidium spp.

Ectromelia Virus ECTR

Encephalitozoon cuniculi ECUN

Hantaan Virus HANT

Helicobater spp. (speciation included) HELICO

Infectious Diarrhea of Infant Rats IDIR

Kilham Rat Virus KRV

Klebsiella oxytoca K. oxytoca

Klebsiella pneumoniae K. pneumoniae

Lactate Dehydrogenase-Elevating Virus LDEV (LDV)

Lymphocytic Choriomeningitis Virus LCM/LCMV

Minute Virus of Mice MVM (MMV)

Mouse Adenovirus - Strain 1 & 2 MAD (FL & K87)

Mouse Astrovirus ASTRV

Mouse Cytomegalovirus MCMV

Mouse Hepatitis Virus MHV

Mouse Norovirus MNV

Mouse Parvovirus MPV

Mouse Rotavirus (Enzootic Diarrhea of Infant Mice) MRV/EDIM

Mouse Thymic Virus MTV (MTLV)

Mycoplasma arthritidis M arthriditis

Mycoplasma pulmonis M pulmonis

Mycoplasma spp. Mycoplasma spp.

Pasteurella pneumotropica P pneumotropica

Pneumocystis carinii P. carinii

Pneumocystis muris P. murins

Pneumonia Virus of Mice PVM

Pneumonitis Virus K Virus

Pseudomonas aeruginosa P. aeruginosa

Polyoma Virus POL

Rat Coronavirus RCA/SDAV

Rat Minute Virus RMV

Rat Parvovirus RPV

Rat Polyomavirus 2 RPyV2

Rat Theilovirus RTV

Reovirus (Types 1-4) REO

Rodent Fur Mite (speciation included) Rodent Fur Mite

Rodent Pinworm (speciation included) Rodent Pinworm

Salmonella spp. Salmonella spp.

Segmented Filamentous Bacterium (SFB) SFB

Individual PCR Assay Agent Abbreviation

Sendai Virus SEND

Spironucleus muris S. muris

Staphylococcus aureus S. aureus

Streptococcus pneumoniae S. pneumoniae

Theiler's Encephalomyelitis Virus TMEV or GDVII

Toolan's H-1 Virus H1

LIST OF LABORATORY ANIMAL DIAGNOSTIC TEST CONTINUNED

Group PCR Assays Agents Included In Panels

EDIM MVM

TMEV

Rodent

Pinworms

HELICO

Mouse Fecal PCR Panel MHV

MNV

MPV

EDIM MVM

TMEV

Rodent

Pinworms

Rodent Fur

Mites

HELICO

Environmental PCR Panel MHV

MNV

MPV

ECTR MAD (FL &

K87)

MCMV

MHV

MNV

MPV (1-5)

MTV

MVM

Mycoplasma spp.

M. pulmonis

POL

REO3

EDIM

Biological PCR Panel HANT

K virus

SEND

TMEV

LCMV

LDEV

Other Specialized Service

MALDI-TOF Microbial Identification

Sequence analysis for microbial Identification

ATTACHMENT V

CONTRACT PRICING LIST

Test Unit Year 1 Year 2 Year 3 Year 4 Year 5

Individual Serology Assay Single assay $__________ $__________ $__________ $__________ $__________

Serological Panels

Mouse Panel 1 Single panel $__________ $__________ $__________ $__________ $__________

Mouse Panel 2 Single panel $__________ $__________ $__________ $__________ $__________

Mouse Panel 3 Single panel $__________ $__________ $__________ $__________ $__________

Rat Panel 1 Single panel $__________ $__________ $__________ $__________ $__________

Rat Panel 2 Single panel $__________ $__________ $__________ $__________ $__________

Individual PCR Assay Single assay $__________ $__________ $__________ $__________ $__________

PCR Panels

Fecal PCR Panel Single panel $__________ $__________ $__________ $__________ $__________

Environmental PCR Panel Single panel $__________ $__________ $__________ $__________ $__________

Biological PCR Panel Single panel $__________ $__________ $__________ $__________ $__________

MALDI-TOF Microbial Identification Single assay $__________ $__________ $__________ $__________ $__________

Sequence Analysis for Microbial Identification Single assay $__________ $__________ $__________ $__________ $__________

Outbreak Testing

Individual Serology Assay

25-50 samples/submission Single assay $__________ $__________ $__________ $__________ $__________

51-100 samples/submission Single assay $__________ $__________ $__________ $__________ $__________

> 100 samples/submission Single assay $__________ $__________ $__________ $__________ $__________

Individual PCR Assay

25-50 samples/submission Single assay $__________ $__________ $__________ $__________ $__________

51-100 samples/submission Single assay $__________ $__________ $__________ $__________ $__________

> 100 samples/submission Single assay $__________ $__________ $__________ $__________ $__________

ATTACHMENT VI

SAMPLE TASK ORDER (STO) STATEMENT OF WORK

FOR PRICE EVALUATION PURPOSES ONLY

1.0. INTRODUCTION: The Contractor perform animal diagnostic testing services in accordance with standard laboratory practices using state of the art microbiological procedures. The Contractor shall receive the biological samples, perform requested testing on these samples and shall provide results to the Government via e-mail, telephone or other electronic source (e.g., online access).

2.0. TASKS: Under this STO, the Contractor shall perform the following tests using the methods described in the

General SOW:

Services Species Agents Included Qty Unit Unit Price Total Price

Individual Serological Assay - Clostridium piliforme M 20 Each $________ $__________

Mouse Serology Panel 2 M M pulmonis 10 Each $________ $__________

Rat Serology Panel 2 R Pneumocystis carinii 15 Each $________ $__________

Individual PCR Assay - Klebsiella pneumoniae 10 Each $________ $__________

Group PCR Assay – Biological PCR Panel Mycoplasma spp. 25 Each $________ $__________

Rat Serology Panel 1 R RCV/SDAV 25 Each $________ $__________

STO Total $ ___________

3.0. GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES: See contract SOW.

4.0. CONTRACTOR FURNISHED ITEMS AND RESPONSIBILITIES: See contract SOW.

5.0. DELIVERY PERIOD: See contract SOW.

6.0. HOURS OF OPERATION: See contract SOW.

7.0. PLACE OF PERFORMANCE: See contract SOW.

8.0. NOTE: The terms and conditions of the basic contract and contract SOW apply to this task order.

ATTACHMENT VII

HISTORICAL DATA

IDIQ Contract HHSN273201400002I Mod (11/13/2017-11/12/2018)

Year/Ceiling Task Order # Date Status Total

Base/$100,000.00

HHSN27300001 12/4/2013 Released $1,143.00

HHSN27300002 12/5/2013 Released $637.50

HHSN27300003 12/11/2013 Released $3,643.25

HHSN27300004 12/12/2013 Released $15,039.00

HHSN27300005 3/19/2014 Released $0.00

HHSN27300006 3/19/2014 Canceled $0.00

HHSN27300007 3/19/2014 Canceled $0.00

HHSN27300008 3/19/2014 Canceled $20,266.50

HHSN27300009 7/11/2014 Released $25,000.00

HHSN27300010 9/3/2014 Released $5,000.00

HHSN27300011 10/17/2014 Released $4,925.00

HHSN27300012 10/20/2014 Released $1,475.00

HHSN27300013 10/28/2014 Released $1,265.00

Total $78,394.25

Year 1/$100,000.00

HHSN27300014 12/4/2014 Released $1,508.72

HHSN27300015 12/18/2014 Released $27,676.40

HHSN27300016 4/30/2015 Released $25,000.00

HHSN27300017 7/21/2015 Released $25,000.00

HHSN27300018 11/5/2015 Canceled $0.00

Total $79,185.12

Year 2/$100,000.00

HHSN27300019 11/13/2015 Released $25,000.00

HHSN27300020 1/26/2016 Canceled $0.00

HHSN27300021 3/7/2016 Released $25,000.00

HHSN27300022 6/21/2016 Canceled $0.00

HHSN27300023 Released $25,000.00

HHSN27300024 11/4/2016 Released $25,000.00

Total $100,000.00

Year 3

(Ceiling $100,000.00)

HHSN27300025 11/7/2016 Released $25,000.00

HHSN27300026 2/22/2017 Released $25,000.00

HHSN27300027 6/6/2017 Released $25,000.00

HHSN27300028 8/2/2017 Not Released $0.00

HHSN27300029 8/18/2017 Released $25,000.00

Total $100,000.00

Year 4/$100,000.00

HHSN27300030 12/18/2017 Released $25,000.00

HHSN27300031 3/5/2018 Released $25,000.00

HHSN27300032 4/27/2018 Released $50,000.00

Total $100,000.00

Contract/$500,000.00 Total Used $457,579.37

ATTACHMENT VII

HISTORICAL DATA CONTINUED

IDIQ Contract HHSN273201400003I Mod (11/06/2017-11/05/2018)

Year Task Order # Date Status Total

Base/$100,000.00

HHSN27300001 7/6/2018 Released $1,143.00

HHSN27300002 12/5/2013 Released $13,672.00

HHSN27300003 12/13/2013 Released $20,168.00

HHSN27300004 4/18/2014 Released $25,000.00

Total $59,983.00

Year 1/$100,000.00

HHSN27300005 7/11/2014 Released $2,377.50

HHSN27300006 12/6/2014 Released $25,000.00

HHSN27300007 12/6/2014 Released $25,000.00

Total $52,377.50

Year 2/$100,000.00

HHSN27300008 5/13/2015 Released $25,000.00

HHSN27300009 3/8/2016 Canceled $25,000.00

HHSN27300010 7/29/2016 Released $25,000.00

Total $75,000.00

Year 3/$100,000.00

HHSN27300011 11/7/2016 Released $25,000.00

HHSN27300012 4/9/2018 Released $25,000.00

Total $50,000.00

Year 4/$100,000.00

HHSN27300013 7/17/2017 Released $25,000.00

HHSN27300014 12/18/2017 Released $25,000.00

Total $50,000.00

Contract/$500,000.00 Total Used $237,360.50

ATTACHMENT VII

HISTORICAL DATA CONTINUED

NOTE: Based off of historical data, the following are estimated quantities projected for each year of the contract

Test Unit Year 1

Individual Serology Assay Single assay 500

Serological Panels

Mouse Panel 1 Single panel 2,000

Mouse Panel 2 Single panel 700

Mouse Panel 3 Single panel 250

Rat Panel 1 Single panel 50

Rat Panel 2 Single panel 50

Individual PCR Assay Single assay 2,000

PCR Panels

Fecal PCR Panel Single panel 40

Environmental PCR Panel Single panel 100

Biological PCR Panel Single panel 200

MALDI-TOF Microbial Identification Single assay 200

Sequence Analysis for Microbial Identification Single assay 50

Outbreak Testing

Individual Serology Assay

25-50 samples/submission Single assay Unknown

51-100 samples/submission Single assay Unknown

> 100 samples/submission Single assay Unknown

Individual PCR Assay

25-50 samples/submission Single assay Unknown

51-100 samples/submission Single assay Unknown

> 100 samples/submission Single assay Unknown