SOW - Animal Health_Diagnostic Testing - 2026.pdf

STATEMENT OF WORK

National Institutes of Health

Division of Veterinary Resources Diagnostic Research Services Branch

Animal Health & Diagnostic Testing Services

I. Statement of Work

A. Background Information

The purpose of this acquisition is to obtain the services of a commercial laboratory for serological analysis, PCR, and related assays of animal sera and tissues used to monitor the health of NIH animal colonies. The National Institutes of Health (NIH) has numerous facilities for maintaining research animals. The health of these animals is 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 NIH research animals as well as ensuring the safety of the researcher and animal care giver. NIH veterinarians oversee the care and use of these animals. They are responsible for monitoring the health status of the animal colonies and making appropriate decisions based on the results of this monitoring. The animals used as sentinels for colony health status are submitted to the Diagnostic and Research Services Branch (DRSB) of the Division of Veterinary Resources (DVR), ORS, OD for evaluation. This evaluation may include, as appropriate, a complete necropsy, examination for parasites, bacterial cultures as well as Polymerase Chain Reaction (PCR) and/or serological assays. Animals or samples from animals which appear ill or die are also submitted to DVR for diagnostic services. DVR is responsible for providing the results of health surveillance and diagnostic testing to the appropriate veterinarian(s), managers and researchers. The scope of this contract will be to perform health surveillance and diagnostic testing necessary to complete the animal health monitoring process. Serological and PCR testing will be requested primarily as the methods of health surveillance testing. Hematology and clinical chemistry analysis may be requested on a limited basis. PCR testing may also be requested for confirmation of an agent’s presence in an animal facility. Bacterial agent identification may be requested selectively for confirmation of bacterial culture results. Other assays, such as Western Blot or Immunofluorescent Antibody (IFA) may be requested to confirm initial equivocal serological results.

B. Objectives

The purpose of the proposed contract is to provide a readily available source of serology assay testing services, PCR and other assays to meet the needs of the DVR and the NIH.

The overall objective is to provide serological testing and PCR assays for the diagnostic and health monitoring programs of the institutes at the NIH.

The specific objective is to have a Contractor receive serology samples, perform testing on these samples and report the results back within 3 workdays to the Contracting Officer’s Representative (COR) and designated personnel. The COR or COR’s designee will then disseminate the results to the appropriate veterinarian and animal facility manager. PCR assay submissions shall be tested and the results provided to the COR within 7 working days. Hematology & Blood Chemistry submissions shall be tested and results reported to the COR and lab manager within 2 working days.

C. Period of Performance:

Base Year: July 1, 2026 – June 30, 2027 Option 1: July 1, 2027 – June 30, 2028 Option 2: July 1, 2028 – June 30, 2029 Option 3: July 1, 2029 – June 30, 2030 Option 4: July 1, 2030 – June 30, 2031

II. Services to Be Performed

A. General Requirements

(1) Independently, and not as an agent of the Government, the Contractor shall furnish all necessary labor, materials, supplies, equipment, and services (except as otherwise specified herein) and perform the work set forth below.

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

B. Specific Requirements

(1) The Contractor shall, as a minimum, perform serological assays by appropriate methods such as Multiplex Fluorescent Immunoassay (MFI), IFA, Enzyme-Linked Immunosorbent Assay (ELISA), Hemagglutination Inhibition (HAI), as appropriate.

Western Blot methodology should be available for confirmatory testing. Should new testing technology become available during the course of this offering, it will be incorporated through modification of the Contract. The Contractor shall perform PCR assays for a variety of agents. The Contractor shall perform Hematology and Blood Chemistry analysis for a variety of analytes. Bacterial agent identification may be requested selectively for confirmation of bacterial culture results.

(2) The Contractor shall propose groupings of pathogens (hereafter referred to as panels) to facilitate the submission of sera for testing and to enable NIH users to develop a standard surveillance routine for their facilities. An NIH user, therefore, will request a specific panel rather than individually list all the pathogens. The Contractor shall propose the same panels as offered to the general public and may develop new panels specifically for the NIH. Once implemented, the COR must be given 60 days notice prior to any changes in the composition of these panels.

(3) The Contractor shall provide submission forms, collection supplies (including but not limited to swabs, tubes, blood spot cards, and environmental test media), and instructions for preparation of serological and PCR samples and packaging of the same. The Contractor shall arrange to pick up the samples from a designated location as provided by the COR. The Contractor shall be responsible for transporting the samples to the testing laboratory and maintaining the samples at that location. The sample information shall be logged into a computerized database at the contract laboratory by the Contractor. The Contractor shall begin testing the samples no later than the next working day after the arrival of the samples in the Contractor’s laboratory. Results of testing shall be recorded in a database and reports generating these results shall be published in an electronic form to be delivered by e-mail or another electronic medium no later than 3 working days after receipt of the serology samples from the Government. The COR and lab manager shall be notified by email or phone of all significant positive results as soon as they are available. The COR or lab manager may request re-testing of any unexpected or equivocal results using either the original or a confirmatory procedure. The COR or lab manager may also request that the questionable sample be sent to another laboratory for retesting at the Contractor’s expense. The Contractor shall perform all requested PCR assays and report the results within seven working days following the receipt of the specimen by the contracting laboratory.

(4) The Contractor’s lab shall be fully equipped (laboratory and computer equipment) to provide serological testing and PCR assays at the time of proposal submission. No instrumentation shall be purchased with the contract funds. Equipment used in these serological and PCR testing procedures shall be maintained in proper working condition. Calibration of all devices and testing equipment shall be performed with sufficient frequency as to ensure accurate results. Positive and negative controls should be routinely utilized as appropriate for all assays.

(5) The COR or lab manager may request expedited processing of any specimens deemed critical by the COR. For these serology samples the Contractor shall process and report test results telephonically or electronically by e-mail within one workday of receipt of the specimen. The COR or lab manager may request expedited processing of PCR assays. These samples shall be processed by the Contractor and result data transmitted to the COR and lab manager within three workdays.

(6) After completion of the serological and PCR assays the test sample (if sufficient sample remains) shall be stored for six months at – 700C. During this period stored samples shall be returned to the COR (or authorized designee) or additional testing shall be performed if requested. After six months the samples may be discarded.

(7) In the event of an outbreak at the NIH of rodent disease caused by an unknown agent(s), the Contractor shall perform or assist in research to help elucidate the cause, pathogenesis, and epidemiology of the causative agent as requested by the COR or lab manager. In this event or in the event of an outbreak of a known rodent agent the Contractor may be requested to handle a greatly increased number of samples for that particular agent. The Contractor shall process these samples and report the results by email transmission within two workdays of receipt of the sera samples and three workdays of receipt of the PCR samples by the Contractor from the Government.

(8) The Contractor shall provide a training program for their employees involved with this contract. Employees shall be trained to perform the testing procedures indicated in this contract. Also, training shall be provided on new techniques which have been approved by the COR. The purpose of rodent health monitoring shall be explained to the employees. Information about rodent infectious agents and their impact on research shall be presented to the employees. A copy of the training program shall be furnished to the COR.

(9) The COR may visit the Contractor's place of work to inspect and review the serological testing and PCR procedures covered in this contract. The COR may tour the facility with a representative of the Contractor. The COR has the option to observe all of the procedures mentioned in this contract while visiting the Contractor.

(10) The government may require that the Contractor send a representative to the NIH

Bethesda campus to make a presentation on this testing program and/or answer questions from the NIH user community. The requirement will not exceed one visit per year.

(11) It is anticipated that this contract will generate approximately 350,000 individual test results per annum. DVR maintains a database used to collate and disseminate these results to the various NIH facilities. The Contractor shall provide the results to DVR electronically in a form that can be easily downloaded into the DVR database.

Historically, this has been accomplished by an e-mail with a downloadable file attached. Advances in IT technology may lead to alternative ways to accomplish this task. The Contractor shall have IT personnel available to work with NIH IT professionals to ensure that this critical interface is functional and efficient.

(12) The Contractor shall maintain an electronic copy of this data for the life of the contract.

(13) Key personnel designated by the Contractor shall include:

a. A Project Supervisor responsible for overseeing all serological and PCR testing related to the contract and personnel. This individual shall have a Ph.D. in microbiology or DVM/VMD from an accredited college of veterinary medicine and be board certified by the American College of Laboratory Animal Medicine. This individual shall have a minimum of five years in laboratory rodent serology testing and PCR assays.

b. The Laboratory Supervisors who are responsible for supervising the laboratory personnel performing the assays may also serve as the principal point of contact for the COR and/or his/her designee. These individuals shall have a minimum of a bachelor’s degree and one year’s supervisory experience with either rodent serologic or molecular diagnostics (PCR) testing.

STATEMENT OF WORK - Testing for FY2025

The following tables give the number of assays requested under the current contract in FY2025 and are presented to give an estimate of the level of work expected in FY2026 and beyond.

FY2025 SEROLOGY TESTS

MICE

Item

AGENT

Quantity of Assays

Requested

A Sendai Virus 4290

B Pneumonia Virus of Mice (PVM) 4,290

C Mouse Hepatitis Virus (MHV) 6,169

D Mice Minute Virus (MMV, MVM) 6,051

E Mouse parvovirus (MPV 1-5) 6,061

F Theiler murine encephalomyelitis virus

(GDVII/TMEV)

6,045

G Epizootic Diarrhea of Infant Mice (EDIM) 6,045

H Lymphocytic Choriomeningitis Virus (LCMV) 4,391

I Ectromelia Virus 4,290

J Mouse Adenovirus 1 (MAV 1) 3,263

K Mouse Adenovirus 2 (MAV 2) 3,263

L Mouse Cytomegalovirus (MCMV) 2,380

M Parvovirus (NS-1) 6,050

N Polyoma Virus 3,206

O Reovirus (REO) 4,290

P Mycoplasma pulmonis 4,290

Q Mouse Norovirus (MNV) 6,053

R Filobacterium rodentium (CAR bacillus) 2,323

S Hantaviruses (Hantaan & Seoul) 1,854

T Clostridium piliforme (Agent of Tyzzer's Disease) 2,324

U Lactose Dehydrogenase Elevating Virus (LDV) 1,847

V Mouse Thymic Virus (MTV) 1,852

Assays

Requested

W Encephalitozoon cuniculi 2,323

X K virus 1,852

Y Mouse Kidney Parvo Virus (MKPV) 106

Total Samples = 6,202 Total Assays=

94,914

RAT

Assays

Requested

A Filobacterium rodentium (CAR bacillus) 198

B Toolan’s H1 451

C Hantaviruses (Hantaan & Seoul) 198

D Mouse Adenovirus (MAV 1) 198

E Mouse Adenovirus (MAV 2) 198

F Parvovirus (NS-1) 451

G Kilham Rat Virus (KRV) 451

H Lymphocytic Choriomeningitis Virus (LCMV) 271

I Pneumonia Virus of Mice (PVM) 327

J Rat Coronavirus (RCV/SDAV) 451

K Reovirus (REO) 271

L Rat Parvovirus (RPV) 451

M Rat Minute Virus (RMV) 451

N Pneumocystis carinii (PCAR) (RRV) 451

O Rat Theilovirus (RTV) 451

Assays

Requested

P Sendai 327

Q Mycoplasma pulmonis 327

R Clostridium piliforme (Agent of Tyzzer's Disease) 198

S Encephalitozoon cuniculi 80

T Rat Rotavirus (IDIR) 80

U Rat polyomavirus 2 (RPyV2) 208

Total Samples = 453 Total Assays=

6,489

GUINEA PIG

Assays

Requested

A Para influenza virus (CavPI3) 31

B Encephalitozoon cuniculi 31

C Lymphocytic Choriomeningitis Virus (LCMV) 31

D Pneumonia Virus of Mice (PVM) 31

F Sendai 31

H Guinea pig adenovirus (GAV) 31

I Mouse Adenovirus (MAV 2) 3

J Clostridium piliforme (Agent of Tyzzer's Disease) 31

K GP cytomegalovirus (GPCMV) 31

GUINEA PIG

Assays

Requested

Total Samples = 31 Total Assays=

RABBIT

Assays

Requested

A Filobacterium rodentium (CAR bacillus) 21

B Encephalitozoon cuniculi 21

C Clostridium piliforme (Agent of Tyzzer's Disease) 21

D Rotavirus 21

E Treponema 21

Total Samples = 21 Total Assays=

HAMSTER

Assays

Requested

A Lymphocytic Choriomeningitis Virus (LCMV) 7

B Simian Virus 5 7

C Clostridium piliforme (Agent of Tyzzer's Disease) 7

HAMSTER

Assays

Requested

D Sendai 7

E Encephalitozoon cuniculi 7

F Pneumonia Virus of Mice (PVM) 7

G Reovirus (REO) 7

Total Samples = 7 Total Assays=

FY2025 PCR PANEL TESTS

Quantity of Assays Requested

A Lymphocytic Choriomeningitis Virus (LCMV) 262

B Mouse Adenovirus (MAV1) 480

C Mouse Adenovirus (MAV2) 480

D Mouse Hepatitis Virus (MHV) 1743

E Mouse Norovirus (MNV) 1743

F Ectromelia (mousepox) 262

G MPV 1750

H MVM 1750

I MRV (EDIM) 1593

J PVM 262

K Reovirus Type 1, 2, 3 262

L Sendai 262

M Theiler murine encephalomyelitis virus

(GDVII/TMEV)

Requested

N Beta Strep Grp A 535

O Beta Strep Grp B 535

P Beta Strep Grp C 535

Q Beta Strep Grp G 535

R Campylobacter coli 226

S Campylobacter jejuni 226

T Filobacterium rodentium (CAR bacillus) 262

U Citrobacter rodentium 466

V Bordetella hinzii 226

W Bordetella bronchiseptica 226

X Clostridium piliforme 457

Y Corynebacterium spp. (HAC2) 226

Z Corynebacterium bovis 271

AA Corynebacterium kutscheri 246

BB Helicobacter 1823

CC Klebsiella oxytoca 533

DD Klebsiella pneumoniae 533

EE Mycoplasma pulmonis 567

FF Rodentibacter heylii 1645

GG Rodentibacter pneumotropicus 1645

HH Pseudomonas aeruginosa 446

II Salmonella 578

JJ Staphylococcus aureus 444

KK Staphylococcus xylosus 226

LL Proteus mirabilis 226

MM Streptobacillus moniliformis 246

Requested

NN Streptococcus pneumoniae 317

OO Cryptosporidium 226

PP Entamoeba muris 1556

QQ Giardia 228

RR Fur mites 2797

SS Pinworms 2950

TT Pneumocystis 226

UU Spironucleus muris 1576

V V Tritrichomonas muris 446

WW Demodex 226

XX Chilomastix 2

YY Ornithonyssus 226

ZZ Hantaan virus 262

AAA Mouse Kidney Parvovirus (MKPV) 251

BBB Polyoma virus 11

CCC Lactose Dehydrogenase Elevating Virus (LDV) 11

DDD Mouse Cytomegalovirus (MCMV) 11

EEE K virus 11

FFF Mouse Thymic Virus (MTV) 11

GGG Encephalitozoon cuniculi 11

Total Samples = 3,123 Total PCR Assays= 36,076

Requested

A Rat Parvovirus (Toolan’s H-1) 113

B Rat Parvovirus (KRV) 113

C Rat Parvovirus (RPV) 113

D Rat Parvovirus (RMV) 113

E Rat Coronavirus (RCV, SDAV) 112

F Theilovirus (RTV) 113

G Adenovirus Type 1 (FL) (MAV 1) 31

H Adenovirus Type 2(K87) (MAV 2) 31

I Reovirus Type 1, 2, 3 30

J PVM 30

K Sendai 30

L Seoul (Hantavirus) 30

M Helicobacter 128

N Mycoplasma pulmonis 33

O Streptobacillus moniliformis 33

P Rodentibacter heylii 127

Q Rodentibacter pneumotropicus (Jawetz) 127

R Clostridium piliforme 31

S Filobacterium rodentium (CAR bacillus) 30

T Pseudomonas aeruginosa 31

U Salmonella 36

V Campylobacter coli 30

W Campylobacter jejuni 30

X Bordetella bronchiseptica 30

Y Corynebacterium kutscheri 30

Z Staphylococcus aureus 31

FY2025 INDIVIDUAL PCR TESTS

SPECIES

Assays

Requested

A Mouse 3115

Requested

AA Streptococcus pneumoniae 45

BB Klebsiella pneumoniae 33

CC Klebsiella oxytoca 33

DD Streptococcus, β-hemolytic (Groups A, B, C, G) 46

EE Proteus mirabilis 30

FF Fur mites 215

GG Pinworm 216

HH Giardia 30

II Spironucleus muris 115

JJ Cryptosporidium 30

KK Entamoeba 112

LL Pneumocystis 30

MM Tritrichomonas muris 31

NN Demodex 30

OO Ornithonyssus 30

PP Boone Cardiovirus (BCV) 31

QQ Staphylococcus xylosus 30

RR Rat polyomavirus 2 (RPyV2) 30

Total Samples = 231 Total PCR Assays= 2,703

FY2025 INDIVIDUAL PCR TESTS

SPECIES

Assays

Requested

B Rat 87

C Guinea pig 229

D Hamster 143

E Non-Human Primate 9

F IMPACT 456

G Other (zebrafish, amphibian, rabbit, sand rat, Peromyscus, woodchuck, etc.)

Total PCR Assays= 4,503