120782 O5 Industrial Lab Response.pdf

Industrial Laboratories 6116 E Warren Ave, Denver, CO 80222

STATE OF NEBRASKA

RESPONSE TO SOLICITATION

120782 O5 Equine Urine and Blood Analysis

CORPORATE OVERVIEW

Bidder Identification and Information / Office Location Financial Statements Change of Ownership Insurance Requirements Relationships with the State Employee Relations to State Contract Performance Corporate Experience Personnel and Management Approach

Work Plan Key Personnel

Drug Testing services team Subcontractors

TECHNICAL PROPOSAL

Sample Collection/Processing/Shipment

Collection Supplies Delivery and Shipping of Supplies Training

Personnel Key Contacts AORC Membership

Facilities Accreditation

ISO/IEC 17025 (A2LA)

RMTC Accreditation

Quality Assurance and Quality Control Internal Blind Analyses EQAP Participation False Positive / False Negative Findings Passed Sample Exchange

Standard Operating Procedures

Sample Management / Sample Retention Scope of Testing

Statement of Work to be Performed Standard Post-Race Screening Analysis Extraction Scheme Vet’s List / Work samples Out of Competition Cobalt Testing Hair Testing TCO2 Analysis Necropsy Samples Elective Testing – Targeted Analysis for Administered Substances Contraband Research And Development

Turn-around Time Screening Results Confirmation Results Request for Extension Special Testing Data Packages

Reports / Communications / Support Screening Reports Positive Reports (Certificate of Analysis) Data Packets Testimony

SUMMARY

CORPORATE OVERVIEW

Industrial Labs has been conducting analytical testing since 1948 and animal drug testing since 1953. We have worked with many diverse clients to provide drug testing services. In addition to the testing services that we provide to our contract clients, we also conduct testing for various private organizations. We are experienced in testing pigeon races, dog pulls, bucking bull competitions, horse pulls, livestock fairs, chariot racing, and sled dog races. Additionally, we provide pre-purchase testing to enforce private sales agreements.

We take pride in outstanding customer service for every client regardless of size, by responding to specific and individual needs, as well as, providing guidance as needed, and by providing superior analytical testing that ensures compliance with the elected and enforced rules and legally defensible findings.

BIDDER IDENTIFICATION AND INFORMATION / OFFICE LOCATION

Company Information:

The Industrial Laboratories Company, Inc. (Industrial Laboratories)

6116 E Warren Ave

Denver, CO 80222

303-287-9691 www.industriallabs.net

The company’s reception area and telephone lines are regularly staffed Monday through Friday, from 8:00 AM to 5:00 PM, MDT/MST.

For questions related to this quote, please contact:

Mr. Seth Wong, President: swong@industriallabs.net

720.214.2014

For questions related to goods and services to be provided, please contact:

Mrs. Petra Hartmann, Director, Drug Testing Services: phartmann@industriallabs.net

720.210.2020

Industrial Laboratories is a C-corporation incorporated in the State of Colorado and currently employs just over sixty employees. Industrial Laboratories only employs individuals permitted to work in the US, is an Equal Opportunity Employer and does not discriminate based on race, color, religion, national origin, ancestry, sex, sexual orientation, or handicap in any matter relating to employment. All employees sign a non-conflict of interest statement upon employment. The key point of contact for this contract is Petra Hartmann, Director, Drug Testing Services.

Our laboratory is accredited for veterinary drug testing to both the ISO17025-2017 quality standard through the American Association of Laboratory Accreditation (A2LA) and by the Racing Medication and Testing Consortium (RMTC).

http://www.industriallabs.net/ mailto:swong@industriallabs.net mailto:phartmann@industriallabs.net

Our proposal includes information on sample collection supplies, sample courier service from the racetrack to the laboratory, testing programs utilizing liquid chromatography-tandem mass spectrometry (LC-MS/MS) for both screening and confirmation, as well as sample handling & storage, facility, and reporting information.

FINANCIAL STATEMENTS

Industrial Laboratories is a private entity and thus its financial statements are not available to entities outside of its shareholders. The lab has been in business since 1945 and under its current group of shareholders since 1994. This 79-year history is testament to Industrial Lab’s financial health and well-being. The company has weathered many economic downturns and changes within its business landscape. The company has the commitment of its shareholders to ensure that the company will continue its long-standing history and commitment to clients and the company’s president is available to, potentially, discuss any other concerns the State may have.

CHANGE OF OWNERSHIP

Industrial Labs affirms that no change in ownership or control of the company is anticipated during the twelve (12) months following the solicitation response due date.

Should any unforeseen changes occur in the future, Industrial Labs will comply with all requirements to notify the State promptly and provide the necessary details.

INSURANCE REQUIREMENTS

Industrial Labs meet all of the insurance requirements and will submit the necessary forms upon contract award and prior to commencement of work, in the event that Industrial Laboratories were to win the RFP

RELATIONSHIPS WITH THE STATE

Industrial Laboratories has been providing equine drug testing analysis in blood and urine for the Nebraska State Racing Commission since 2020. The testing services were successfully transitioned to Industrial Laboratories in 2020, ensuring seamless continuity of operations. We value the opportunity to maintain our partnership with the State and remain committed to delivering reliable and accurate testing services.

In the last three years (2022-2024), Industrial Labs has detected 52 suspicious findings with 16 of those detections resulting in an Adverse Finding. Given the opportunity Industrial Labs will continue to work toward maintaining integrity in racing in the State of Nebraska.

EMPLOYEE RELATIONS TO STATE

Industrial Labs declares that no individuals named in our solicitation response are or were employees of the State within the past five (5) months. This statement confirms that no such relationships exist or have existed during the specified timeframe.

Additionally, Industrial Labs declares that no employees of any agency of the State of Nebraska are currently employed by or subcontracted to Industrial Labs as of the solicitation response submission due date. This statement confirms that no such relationships exist, and there are no potential conflicts of interest to disclose.

CONTRACT PERFORMANCE

Industrial Labs declares that it has not had any contracts terminated for default during the past ten

(10) years. There have been no instances in which Industrial Labs received a notice to stop performance due to non-performance or poor performance, nor has the company been determined to be in default through litigation or otherwise.

Additionally, Industrial Labs has not experienced contract termination for convenience, non-performance, non-allocation of funds, or any other reason during the past ten (10) years.

This declaration reflects our commitment to fulfilling contractual obligations with the highest standards of quality and professionalism.

Should you require any additional details or supporting documentation, please feel free to contact us.

CORPORATE EXPERIENCE

The following is a list of clients that have contracted Industrial Laboratories’ services for equine drug testing in the past 5 years. We also encourage you to contact our clients for any additional clarification, references, and testament to our successful drug testing program. Industrial Laboratories has not had a contract terminated before the end of the contract period due to performance issues, quality issues, or problems with our testimony or legal documents. All our clients are similar in the scope of services that we provide.

State of Arkansas – Arkansas Racing Commission (Currently Horse racing, previously also dog racing)

1515 West 7th Street, Suite 505 Litle Rock, AR Dr. Joe Lokanc, Chief Veterinarian, Joseph.Lokanc@dfa.arkansas.gov

(630) 632-1601

Industrial Laboratories was an official testing laboratory for the State of Arkansas from 1971 to 1995 and has recently been selected as the primary laboratory again, beginning with the 2021 racing season.

State of Arizona – Department of Racing (Currently Horse racing, previously also dog racing) 1110 West Washington Street, Suite 260 Phoenix, AZ 85007 Dr. Susan Gale (480)-266-9852, sgale@azgaming.gov

Industrial Laboratories has been an official testing laboratory for the State of Arizona since 1991.

State of Colorado – Division of Racing Events (Currently Horse racing, previously also dog racing) 1881 Pierce Street, Room 108 Lakewood, CO 80214

(303) 866-6597

Industrial Laboratories has continuously served as the official testing laboratory for the State of Colorado since 1953.

State of Delaware - Department of Agriculture (Harness racing) Harness Racing Commission 2320 S. DuPont Hwy.

DuPont, DE 19901

(302) 698-4599 Ms. Lauren Saveikis, Chief Investigator, lauren.saveikis@delaware.gov

Industrial Laboratories has been an official testing laboratory for the State of Delaware (Standardbred) since 2021.

Horseracing Integrity and Safety Authority/Horseracing Integrity and Welfare Unit (HISA/HIWU) 4801 Main Street, Suite 350 Kansas City, MO 64112

(816) 285-1425

Industrial Laboratories has been working with HISA/HIWU since the inception of the organization in 2023.

State on Indiana Indiana Horse Racing Commission 1302 N. Meridian, Suite 175 Indianapolis, IN 46202

(317) 233-3119 Ms. Deena Pitman, dpitman@ihrc.IN.gov

Industrial Laboratories has been the official testing laboratory for Indiana since 2016.

State of Iowa - Iowa Racing and Gaming Commission (Currently Horse racing, previously also dog racing) 1300 Des Moines St., Suite 100 Des Moines, IA 50309-5508 Ms. Tina Eick, Director of Operations, tina.eick@iowa.gov

(515) 281-3451 mailto:dpitman@ihrc.IN.gov mailto:dpitman@ihrc.IN.gov

Industrial Laboratories has been the official testing laboratory for Iowa since 2018.

Commonwealth of Kentucky Kentucky Horse Racing and Gaming Corporation 4063 Iron Works Parkway, Building B Lexington, KY 40511 Ms. Jamie Eads, Executive Director, Jamie.Eads@ky.gov 859-246-2040

Industrial Laboratories is the primary testing laboratory for Kentucky as of 2024. Industrial Laboratories was the primary testing laboratory for Kentucky from 2018 to 2021 as well.

State of Louisiana Louisiana State Racing Commission 320 N Carrollton Ave, Suite 2-B New Orleans, LA 70119 Stephen J Landry, Executive Director, slandry@lrc.state.la.us

(504) 483-4000

Industrial Laboratories was awarded the Louisiana contract in October 2023.

State of Maryland Maryland Racing Commission 10th Floor 501 St. Paul Place Baltimore, MD 21202 Mr. Mike Hopkins, Executive Director, mike.hopkins@maryland.gov

(410) 333-6267

Industrial Laboratories has been testing Maryland samples since 2021.

Commonwealth of Massachusetts Massachusetts Gaming Commission (Horse and Harness racing) 101 Federal Street, 12th Floor Boston, Massachusetts 02110 Dr. Alex Lightbown, Director, alexandra.lightbown@massgaming.gov

(617) 979-8436

Industrial Laboratories has been the official testing laboratory for Massachusetts since 2016.

State of Michigan Michigan Gaming Commission (Horse and Harness Racing) Cadillac Place 3062 West Grand Blvd.

Suite L-700 Detroit, MI 48202 Mrs. Heather Gaunt

(313) 456-4130

Industrial Laboratories was the official testing laboratory for Michigan since 2017 until their closure in 2024.

State of Minnesota Minnesota Racing Commission (Horse and Harness racing) P.O. Box 630 1100 Canterbury Road Shakopee, MN 55379 Dr. Lynn Hovda, Chief Veterinarian, Lynn.hovda@state.mn.us

(612) 860-5806 (cell)

Industrial Laboratories has been the official testing laboratory for Minnesota since 2008.

State of New Jersey New Jersey Racing Commission

CN-088

140 E. Front St.

Trenton, NJ 08625 Dr. Kathleen Picciano, Kathleen.Picciano@njoag.gov

(609) 292-0613

Industrial Laboratories has been the official testing laboratory for New Jersey since 2021.

State of New Mexico New Mexico Racing Commission 4900 Alameda Blvd. NE Albuquerque, NM 87113 Mr. Ismael (Izzy) Trejo, Executive Director, Ismael.Trejo@rc.nm.gov Office: 505.222.0714

Industrial Laboratories has been the official testing laboratory for New Mexico since 2018

State of North Dakota North Dakota Racing Commission (Horse racing) 500 N 9th Street Bismarck, ND 58501-4509 Mr. Bruce Johnson, Executive Director, johnsonbruce@nd.gov 701-328-4290

Industrial Laboratories has been the official testing laboratory for North Dakota for over twenty years.

State of Oklahoma Oklahoma Horse Racing Commission (Horse racing) 2401 NW 23rd Street, Suite 78 Oklahoma City, OK 73107 Dr. John Chancey, Executive Director, jchancey@ohrc.gov

(405) 943-6472

Industrial Laboratories has been the official testing laboratory for Oklahoma since 2006.

Commonwealth of Virginia Virginia Racing Commission (Horse racing) 10700 Horsemens Road New Kent, VA 23124 Ms. Ada Caruthers, Equine Medical Director, ada.caruthers@vrc.virginia.gov

(804) 966-7404

Industrial Laboratories has been the official testing laboratory for Virginia since 2018.

State of Washington Washington Horse Racing Commission 6326 Martin Way, Suite 209 Olympia, WA 98516-5578 360-459-6462 Mrs. Amanda Benton, Executive Director amanda.benton@whrc.wa.gov

Industrial Laboratories has been the official testing laboratory for Washington since 2021.

State of West Virginia West Virginia Horse Racing Commission (Horse racing) State Capital Complex West Wing, Room 317 Charleston, WV 25305-3327 Mr. Joe Moore, Executive Director, joe.k.moore@wv.gov

(304) 558-2150

Industrial Laboratories has been the official testing laboratory for West Virginia since 2015 State of Wyoming Wyoming Gaming Commission Energy II Building 951 Werner Court, Suite 335 Casper, WY 82601

(307) 265-4015 Mr. Charles Moore, Executive Director, Charles.moore@wyo.gov

Industrial Laboratories has been the official testing laboratory for Wyoming since 2021.

PERSONNEL AND MANAGEMENT APPROACH

WORK PLAN

Timeline Description of Task and position that will Implement task

Prior to Racing

Season

Supplies for collecting samples sent to Racetrack. Implemented by DTS Logistics Staff

Start of Race Days

Samples collected by Racetrack. Implemented by designated staff at test barn

Beginning of testing

Samples shipped to Industrial Laboratories. Implemented by FedEx

Next Business Day After

Shipment

Samples registered in LIMS. Implemented by Sample Accessioners. Samples have Chain of Custody assigned to Secure Storage.

TCO2 testing starts. Implemented by Racing Analysts. After testing, samples have Chain of Custody assigned to Secure Storage.

Cobalt testing (if any) will be Aliquoted and sent to UK VDL for testing.

Implemented by Sample Accessioners, FedEx, and UK VDL.

Target Screen Analysis starts. Implemented by Racing Analysts. After testing, samples have Chain of Custody assigned to Secure Storage.

Coolers / Additional

Supplies to Track

Cooler(s) that were sent to Industrial Laboratories are cleaned and sent back to racetrack for future race days to be sent to the lab. (Any supply requests from the racetrack will be sent as well) Implemented by DTS Logistics Staff.

Supply Shipment Sample Collection

Sample Shipment

Sample Received Sample Testing Results Entered Report Sent

Racetrack

WORK PLAN

RACEHORSE-RELATED ANALYTICAL TESTING

Within 5 Business

Days of Receipt

All initial testing is complete, results reviewed and reported. Implemented by Senior Staff.

After testing, if negative, samples have Chain of Custody assigned to Secure Negative Storage.

Within 5 Business

Days of Receipt

Any samples flagged as Suspect are pulled for confirmation testing.

Implemented by Racing Chemist.

Samples have a Chain of Custody assigned to Secure Suspect Storage.

Within 10 Business

Days of Receipt

All confirmation testing done, results reviewed and reported. Implemented by Senior Staff.

After testing, Positive samples have Chain of Custody assigned to Secure Positive Storage, and Negative samples have Chain of Custody assigned to Secure Negative Storage.

30 Days After Receipt

Sample assigned to Negative Storage can be disposed of. Implemented by Sample Accessioner

90 Days After Receipt

Samples assigned as Suspect, but confirmed No Violation can be disposed

of. Implemented by Sample Accessioner

3-5 Years After Receipt

Samples confirmed as Positive, can now be disposed of. Implemented by Sample Accessioner

KEY PERSONNEL

Short biographies of our senior staff follow. Resumes are provided as a separate attachment.

Provided are a portion of our staff’s resumes. Due to the number of employees at Industrial Labs we have provided resumes for Key Personnel and a portion of the staff.

Attachment - Resumes

Petra Hartmann – Laboratory Director – Primary Client Contact

720.214.2020 phartmann@industriallabs.net

Petra is the Director of the Drug-Testing Services Laboratory. She has been involved with the technical aspects of equine and canine drug testing at Industrial Laboratories for over 36 years and has served in a management capacity for over 22 years. In her capacity as Laboratory Director, she is responsible for laboratory staffing, all aspects of testing, monitoring turn-around time compliance, data review, reporting, budgeting and business planning, as well as project management and client services. She additionally maintains responsibility for our quality control and quality assurance programs, including accreditation compliance. Her experience in laboratory operations has assisted IL in developing a systematic and detailed approach to drug testing, and in monitoring the validity of all results and quality control data. She has a Bachelor of Arts degree in Chemistry and a Master of Science degree in Pharmaceutical Sciences with an emphasis on Drug Chemistry. Petra is a Fellow member of the Association of Official Racing Chemists (AORC) and serves on the Executive Board, as well as on the TCO2 Committee and the Reference Materials Management Committee. She is also active in the Racing Medication and Testing Consortium (RMTC) as co-chair of the Scientific Advisory Committee. Petra is a Certifying Scientist for the laboratory and is experienced in and available for expert witness testimony regarding all aspects of analysis.

Timothy Krueger – Senior Chemist – Screening and Confirmation

720.214.2032 tkrueger@industriallabs.net

Tim joined Industrial Laboratories in 2003 and is employed as a Senior Chemist. Tim performs quantitative and qualitative analysis using primarily LC-MS/MS and GC-MS test methods. Tim obtained his Bachelor of Science degree in Biology from Jamestown College in Jamestown, North Dakota in 2003. In his role at the laboratory, Tim actively supports the continuing development of the lab by researching and implementing new test methods, as well as troubleshooting any technical issues. He also functions as a reviewer and is available to provide client support. Tim is a professional member of the AORC.

Dr. Karen L’Empereur – Senior Scientist

Dr. L’Empereur serves as the Senior Scientist for the Drug Testing Services department. Karen obtained her Ph.D. in Analytical Chemistry in 1989 from Colorado State University in Fort Collins, Colorado. Dr. L’Empereur has a wealth of experience with state-of-the-art instrumentation procedures, such as LC-MS, LC-MS/MS, and GC-MS. Her previous experience includes drug analysis, natural products analysis, and she has extensive experience in method development and validation. In her previous professional experience, she has held positions of Quality Manager, Method Development Chemist, and Senior Research Chemist. At Industrial Laboratories she is responsible for our department internal QC program, the development of new drug detection methods, troubleshooting analytical problems, acting as a certifying scientist, and assisting in the development of our professional staff. Karen is an affiliate member of the AORC and has been with Industrial Laboratories since 2015.

Steve Cantrell – Instrumentation Specialist / Chemist

Steve joined Industrial Laboratories in 2015 as an Analytical Chemist. He has a Bachelor of Science degree in Forensic Chemistry with a minor in Chemistry from Pennsylvania State University. He has previous experience in drug testing as a validation and method development chemist and his primary functions include LC-MS/MS management, data review and confirmatory analysis. Steve is an AORC professional member.

Michael Oviatt – Laboratory Manager

720.214.2036 moviatt@industriallabs.net

Michael assumed the role of Analytical Chemist upon joining our team in December 2016. Holding a bachelor's degree in chemistry from Metropolitan State University of Denver, he brings valuable expertise garnered from previous laboratory experience in human drug testing procedures. Michael's proficiency encompasses extraction, confirmation, equipment, and instrument maintenance, as well as data processing. As a professional member of the AORC, Michael takes on significant responsibilities in his capacity. His primary duties involve the management of confirmatory analysis, staff training, implementation of new methods, meticulous maintenance of method documentation, and ensuring strict compliance with accreditation and client requirements. His contributions play a pivotal role in upholding our laboratory's standards of excellence.

Andrea Jones – Laboratory Manager / Administrator

720.214.2033 ajones@industriallabs.net

Andrea became a valued member of our team in the third quarter of 2016, contributing to a diverse range of responsibilities spanning both laboratory operations and administrative functions. Holding a Bachelor of Science degree in Evolutionary Anthropology from the University of Michigan, she brings a wealth of experience in various laboratory procedures, including sample processing, chain of custody, and sample management.

In her current position at the laboratory, Andrea assumes a managerial role overseeing sample receiving, screening analyses, supply management, and actively contributes to sample reporting and invoicing processes. Her multifaceted skill set, and academic background make her a valuable asset to our team.

DRUG TESTING SERVICES TEAM

SUBCONTRACTORS

Industrial Labs utilized the University of Kentucky, Veterinary Diagnostic Laboratory for metals analysis, primarily Cobalt testing. To ensure compliance with the 2023 TOBA/AGS Testing Protocol, we are also testing 10% of your samples for Cobalt. This service is included in the proposed routine pricing.

This testing is best performed using Inductively Coupled Plasma Mass Spectrometry (ICP-MS), a technology mainly used in the environmental field for metals testing. Currently, the annual sample throughput for Cobalt is insufficient to justify purchasing a specialized piece of equipment, expenses greater than $200,000. To maintain a competitive market price, we thus propose to use the University of Kentucky Veterinary Diagnostic Laboratory (UK VDL) for Cobalt and random Arsenic testing using a validated ICP-MS procedure in place at their facility in Lexington. UK VDL has served as an official laboratory for cobalt testing for Industrial Labs. The laboratory has more than five (5) years of experience in the analysis of official pari-mutuel samples for Cobalt testing and is accredited to the standards of the American Association of Veterinary Laboratory Diagnosticians (AAVLD).

University of Kentucky Veterinary Diagnostic Laboratory

1490 Bull Lea Rd.

Lexington, KY 40511

Phone: (859) 257-8283 Fax: (859) 255-1624 https://vdl.uky.edu/testinformation?keywords=sequine

TECHNICAL PROPOSAL

SAMPLE COLLECTION/PROCESSING/SHIPMENT

Industrial Laboratories will bear all costs associated with shipping supplies to the racetracks, the return shipment of empty coolers back to the track, and the expedited transportation of samples to the laboratory.

Based on your specific racing schedules, we propose to use either Federal Express priority overnight shipping services or Airspace for your samples.

There are several discernible differences between FedEx and Airspace shipping services. The FedEx process necessitates a test barn staff member to deliver the cooler to a nearby FedEx facility or wait fora driver during a longer pickup window, whereas Airspace facilitates the collection of the cooler directly from the test barn at a designated time, typically two hours following the last post time. Notably, Airspace operates on an on-demand basis, available round-the-clock, seven days a week, whereas FedEx provides priority overnight shipping exclusively from Monday to Friday. The added level of service that Airspace provides does result in an increased cost.

When the samples are ready for shipment, they are carefully placed in the provided cooler labeled with “exempt animal specimen” stickers and packed with sufficient https://vdl.uky.edu/testinformation?keywords=sequine ice packs and padding to ensure sample integrity is maintained through the short transit from racetrack to lab. If requested, Industrial Laboratories will supply a comprehensive workflow on how to pack samples into the provided coolers to ship to the lab to ensure that samples are not damaged in transit.

Once the cooler has arrived at the lab, the cooler will be inspected for any tampering, this will be noted on a “Sample Check-in Form”, and the samples will be removed from the cooler to be registered into our Laboratory Information Management System (LIMS).

COLLECTION SUPPLIES

Industrial Laboratories will provide the Commission and its staff with supplies and guidance to help produce quality samples for an accurate and efficient testing program. A superior testing program starts with a collection process that yields high quality test samples. Our supplies are carefully chosen to ensure legal defensibility and samples of the highest integrity.

DELIVERY AND SHIPPING OF SUPPLIES

All collection and shipping supplies will be maintained at the tracks and all supplies for the season will, pending availability, be sent in a single shipment prior to the beginning of the season, no later than 2 days prior to the start of racing. Generally, Industrial Laboratories employs a system of shipping in bulk directly from our vendors to the tracks, although we maintain emergency inventory at the laboratory to prevent back-ordered supplies from impacting or interfering with sample collection. If the test barn staff needs additional supplies, they can call, e-mail, or insert a supply order form into the cooler with the samples to notify us of such a demand. When urgent requests are made the lab can provide rapid response from our in-house stock, although larger quantities will need to be ordered through our vendors.

We can provide the test barns with the following collection supplies:

Securable, insulated shipping containers of suitable size

Ziplock bags, both gallon and quart-sized, for sample packaging to provide extra leak protection

Metal strip seals (numbered)

Locks (keyed)

Urine collection poles

Urine collection cups, 1 per sample, 120 mL capacity, sterile, with lids

Urine specimen cups, 2 per sample, 30 mL or 60mL capacity, sterile, with leak-proof caps

Serum separator tubes, 3 per sample, 8.5 mL capacity, Vacutainer brand

Needles, multi-draw, 1 per sample, 20-gauge, 1 ½ inch length or 18-gauge, 1 ½ inch length

Needle holders

Sample ID tags, sequentially numbered, barcoded, with 8 removable stickers for use on specimen containers and paperwork, 1 per sample.

Evidence tape strips, in bundles or rolls, in sufficient quantity to use approx. 4-6 inches per specimen container.

Sample Submission forms to chain of custody documentation.

Below are example photos and descriptions of collection supplies:

All of our supplies provide the necessary design to meet Industrial Laboratories' Minimum Sample Volume Requirements outlined below.

TRAINING

If desired, Industrial Laboratories can provide familiarization of Industrial Labs’ supplies, shipping, and answer questions in person with test barn staff. To properly facilitate this process, the lab is willing to send two staff members to visit, meet with collection staff, review processes and answers questions related to specific supplies as well as review the shipping process and ensure all questions are answered.

If an in-person meeting with test barn is not of interest or possible, Industrial Labs is glad to provide written guidelines for sample collection and shipping that can be referenced by test barn staff, if this fits within your documentation scheme.

PERSONNEL

KEY CONTACTS

Upon contract award, we will provide you with contact information for key personnel for use during non-laboratory hours.

Petra Hartmann (primary), 720.214.2020, phartmann@industriallabs.net

Tim Krueger, 720.214.2032, tkrueger@industriallabs.net

Michael Oviatt, 720.214.2036, moviatt@industriallabs.net

Andrea Jones, 720.214.2033, ajones@industriallabs.net

AORC MEMBERSHIP

Our drug testing team (6) has active members of the AORC. We assure you that at least one senior staff member will retain professional membership for the duration of the contractual agreement.

The Professional AORC members of our team are:

1. Petra Hartmann

2. Tim Krueger

3. Steve Cantrell

4. Michael Oviatt

The Affiliate AORC members of our team are:

1. Dr. Karen L’Empereur mailto:phartmann@industriallabs.net mailto:tkrueger@industriallabs.net mailto:moviatt@industriallabs.net mailto:ajones@industriallabs.net

2. Seth Wong

Pending AORC membership applications:

1. Andrea Jones

2. Bridget Robinson

3. Lynsey Douglass

4. Lisa Hardy

5. Logan Drill

6. Michelle Samaras

7. Nicole Pike

The AORC is an international group of racing chemists that work exclusively in the field of pari-mutuel drug testing and collaborate to further the science of testing performance animals. The group was formed in Chicago, Illinois in 1947 and today has active members in more than twenty-six countries across the globe. The objectives of the organization are shown on the AORC website as:

Petra Hartmann recently became a fellow-level member of the organization. Our professional AORC members include Tim Krueger, Steve Cantrell, and Michael Oviatt. Dr. L’Empereur is an affiliate member.

According to the AORC Constitution and Bylaws, the membership classifications are defined as follows, Affiliate membership:

Professional membership:

Fellow membership:

Petra Hartmann served as the President of the AORC Americas Section which encompasses members in the US, Canada, and South America for a two-year term which concluded in April 2018.

Petra also served on the national Executive Board of the AORC as a Non-Ex Officio member and participated in two Committees: Reference Standard Best Practices and TCO2 testing methodologies.

We attend US-based conferences, as well as the bi-annual international meeting, to remain informed about drug findings and new methods in place at racing laboratories across the world.

FACILITIES

Industrial Laboratories has been in business since 1945 and has more than seventy years of experience in animal drug testing. Throughout our extensive career, we have worked with many diverse clients to provide drug testing services. Currently, our clients range from very small organizations that send 5 samples once per year, to large racing jurisdictions that send several thousand blood and urine samples over the course of the year.

Industrial Laboratories occupies a 30,000 square-feet facility. We moved into our current facility in late 2021. There are 42 full-time employees in the Drug Testing Services Department.

Access to the Industrial Laboratories and the various laboratories is controlled by electronic key fob.

Each employee is given a personalized access fob that allows them entrance to the building and applicable labs. The access fob is controlled by computer software that monitors employees’ entrances and exits. Fob permissions can be changed by the system administrator at any time to prevent access.

Industrial Laboratories Drug Testing Services’ samples are controlled and secured within a locked walk-in refrigeration unit. Only DTS staff have access to these samples. Additionally, security cameras monitor the drug sample storage facility. Positive samples are kept in locked freezers in a separately secured DTS zone. Security cameras also monitor the remainder of Industrial Laboratories’ facilities. When the building is not occupied, the Industrial Laboratories’ facility is monitored by an alarm company. If the alarm is triggered, police are dispatched to the laboratory and the on-call staff member is notified.

Samples are secured by restricting access and employing locked storage facilities (both refrigerated short-term storage and frozen long-term storage). Any time a sample is accessed for testing by an approved IL employee, it is noted in the Laboratory Information Management System (LIMS). Positive samples are additionally secured with sealed evidence bags for long-term frozen storage.

Industrial Laboratories utilizes several different methods to ensure that its’ data and instrumentation are backed up regularly and securely. Industrial Labs backs up all data through the CrashPlan Pro backup system, a cloud-based backup system. This ensures that whenever a change is made to a file, that file is then remotely saved with the amended change. Additionally, IL backs up data on a regular basis through a tangible hard drive that is removed from the premises to ensure the previous weeks’ data is stored in a safe facility separate from our laboratory in the event of a catastrophic incident. Furthermore, Industrial Laboratories backs up all data to an additional external hard drive on a quarterly basis. Industrial Laboratories methods, sequences, and data generated are all backed up per this procedure and thus can provide immediate support and minimize service interruption in the event of a catastrophic failure. The company is secured through a 24-hour alarm system that notifies senior management in the event of catastrophic failure. Our critical equipment is available in duplicate, to provide back-up, and we maintain agreements with various vendors for emergency repair.

ACCREDITATION

Industrial Labs has been a supporter of laboratory accreditation dating back to the 1990’s, when we were among the first racing laboratories to seek accreditation to the International Standards Organization (ISO) standards in 1995. Accreditation assures our clients of the existence of a strong management system that is dedicated to the accuracy and quality of our testing through the implementation of documented and controlled processes, the existence of well-trained staff, the use of suitable technical methods, and the existence of internal and external proficiency programs.

We are accredited by both the American Association for Laboratory Accreditation (A2LA) and the Racing Medication and Testing Consortium (RMTC).

ISO/IEC 17025 (A2LA)

Industrial Laboratories is accredited to ISO/IEC 17025 by the American Association of Laboratory Accreditation, the premier third-party nonprofit accrediting body. The following is a list of all our certificates for accreditation and the relevant Chemistry scope which is the accreditation for our Drug Testing Services Department. Our next audit is scheduled for February 2025 which will cover both ISO/IEC 17025 standards and RMTC/HEAL requirements.

Upon completion of the audit, we will provide the NGRC with a list of any identified deficiencies along with a summary of our corrective actions to address them.

RMTC ACCREDITATION

This certificate is Industrial Laboratories’ accreditation to the Racing Medication Testing Consortium

(RMTC)

QUALITY ASSURANCE AND QUALITY CONTROL

Industrial Laboratories ensures the validity and quality of its data through strict quality protocols. To support the company’s quality initiative, IL employs a Quality Assurance and Control Team consisting of Joanne Compton, Director of Quality Assurance and the lab’s Quality Control Officer, Ms. Maria Bialecki. Maria is dedicated to monitoring and continuously improving quality in our company. Some of her duties include helping manage the drug testing laboratory with accreditation initiatives, performing internal audits of all laboratory areas, and monitoring our internal and external quality control program. The Quality Officer also maintains the company’s calibration system, which ensures that pipettes, balances, and thermometers, etc., are accurate.

Additionally, Maria maintains and continually monitors laboratory documentation, such as the Quality Manual and the standard operating procedure manuals.

Industrial Laboratories participates in external proficiency testing programs provided by both the AORC and the RMTC. Additionally, Industrial Laboratories receives external proficiency samples through American Proficiency Institute for Total Carbon Dioxide testing and Specific Gravity. We have superior records of performance in both programs. As per the requirements of our accreditation, we will provide the State with proficiency testing results within 2 weeks of our receipt of the final results.

We also conduct internal proficiency testing programs on an ongoing basis, and we engage in a sample exchange program with HIWU, which involves testing samples that have been declared negative to ensure that our screening program is optimized always. This has been a very valuable program.

More than 10% of our routine screening samples are quality assurance samples. On average, we analyze approximately 2500 individual QA samples in our screening program on an annual basis.

Over the course of three years, we have analyzed well over 8000 QA samples. The performance of each sample is tracked in a positive control log and a negative test result leads to re-analysis and a formal Corrective and Preventative Action to determine the root cause of the failure.

Confirmation analysis contains a minimum of one positive and one negative control, and quantitative confirmations use 5-7 quantitative calibrators, consisting of matrix blanks supplemented with known amounts of reference standards, as well as blanks, and a positive control supplemented at the threshold level. Last year IL confirmed more than 1000 medication violations.

Quality control samples for threshold violations are monitored in control charts which are used for measurement uncertainty calculations.

All quality assurance samples are reviewed by a senior staff member immediately upon completion of the test and are tracked and monitored by the Laboratory Director and Quality Manager.

Being accredited by both A2LA and RMTC assures all our clients that we have documented quality programs in place, and a designated, qualified Quality Assurance / Quality Control Officer on staff that has the authority to execute the duties of the position.

INTERNAL BLIND ANALYSES

Dr. Karen L’Empereur oversees our laboratory’s internal blind sample program. Dr. L’Empereur prepares blind samples for both blood and urine and introduces them into the routine operations to determine the efficacy of the test and the performance of staff. Substances are chosen from a list of pre-determined compounds at relevant concentrations. This list is reviewed and updated on a yearly basis. Generally, candidate drugs are chosen based on two factors; the RCI and RMTC Controlled Therapeutic Medication list, and the TOBA “mandatory drugs”. Industrial Laboratories can issue an annual report that includes a summary of blind sample analysis, results, any corrective action reports resulting from incorrect blind sample results, as well as reports from external programs, such as negative exchange programs, AORC-EQAP and the RMTC-EQAP.

Given the substantial volume blind samples processed over the previous 90days, we invite NRGC to review these documents during an on-site visit to our facility or via teleconference. Multiple screen checks are incorporated into screening batches for blood, urine, and ELISA, resulting in the processing of hundreds of internal blind samples annually.

EQAP PARTICIPATION

We participate in proficiency testing programs offered by the AORC, the RMTC, and HIWU and our record has been superior. If awarded the contract, we agree to provide all official results from external programs within 2 weeks of receipt of finalized results at the laboratory. Please see the reports of our most recent proficiency test results in Attachment “Proficiency Results” following this proposal.

As our long-standing and continuous accreditation status shows, our auditors have verified our proficiency testing results. We invite you to review all records related to our performance at our facility in Denver, Colorado.

FALSE POSITIVE / FALSE NEGATIVE FINDINGS

Industrial Laboratories has successfully completed all proficiency tests. Our internal QC activity consists of internal blinds and daily quality control samples which have demonstrated that we have no confirmed false positives as part of this program. False negatives occur infrequently, the root cause of which have been identified as process issues, such as mis-spiking the sample with a concentration too low for routine detection in research samples. Documentation regarding our process and results are available for viewing at our facility.

Once our results have been issued, we typically are not informed of any subsequent actions taken by the client unless a hearing is scheduled. In cases where analytic findings would be dismissed due to the issues mentioned, these matters would be thoroughly reviewed and addressed through our quality assurance processes. Appropriate corrective actions would be implemented to mitigate future occurrences.

PASSED SAMPLE EXCHANGE

We currently engage in a monthly passed sample exchange with HIWU as well as other jurisdictions on a random basis. This program, before HIWU, has existed for approximately the last five years and we are only aware of one occurrence that indicated our screen missed a drug. The compound in question was budesonide, which was not targeted by our test at the time and the drug was detected by Florida in one of our samples. We immediately added the drug to our screen and have not encountered any other reports of false negatives.

In summary, please know that quality assurance and quality control are fundamentals of our analysis. To ensure the constant validity of our results, we employ various systems designed to minimize or eliminate potential pitfalls. Our quality systems include:

1. Daily tuning and/or calibration procedures of all instrumentation. Preventative maintenance programs and/or service contracts to minimize breakdown of equipment or potential downtime. All records related to this are maintained for review. Calibration and certification of pipettes, thermometers, and other measuring equipment. Balance checks and accuracy verification. Temperature monitoring of sample refrigerators and freezers.

2. The use of positive and negative matrix control samples in every analytical batch. All control samples are recorded and traceable. Failure of a positive control samples will result in rejection of the batch. The analysis will be repeated, and an investigation into the failure will be performed and documented.

3. Certifying scientist review of all data generated, prior to release of any results.

4. Participation in available proficiency programs, and cooperation with other laboratories to refine methodologies and reduce inter-laboratory differences, as well as the analysis of internal and external blind samples, when available. IL participates in proficiency testing programs offered by the AORC and RMTC. Proficiency testing by the AORC includes the analysis of six blind samples submitted annually. IL has a 100% compliance rate using our instrumental screening methods for proficiency testing. The RMTC proficiency program is administered twice per year to accredited laboratories, and we have participated in all proficiency rounds available to us, with a 100% pass rate.

5. Re-checks of random samples for false negative results. IL engages in a negative sample exchange program with another racing laboratory to ensure the efficacy of our screening methods. By comparing results to those obtained by another laboratory's screening program we can determine if we have any gaps in drug coverage. We have engaged in this exchange for the last 4 years, and we have only had one instance when the other laboratory detected a substance that was not covered in our screen, a Class 4 drug ("Budesonide"), which has since been added to our target screen.

6. Internal and External audits of laboratory operations. Internal investigation procedures.

Corrective Action Procedures and Root Cause Analysis of all quality-related failures. Internal audits are performed by our quality department and are documented for review by our external auditors. Any non-compliant findings result in a Corrective and Preventative Action Report (CAPA) and require resolution within 30 days of the documented finding.

7. Documentation of all quality-related systems in a company Quality Manual.

8. The availability of written Standard Operating Procedures to all technical staff for training and reference. Validation of all methods used for routine analysis in a manner that is compliant with industry standards.

9. The continuous training and education of our staff is documented in individual training files.

10. Obtaining quality supplies from reputable vendors. Validating all reference standards used in analysis. Maintaining a documented control system for all chemicals, reagents, standards, etc., to ensure traceability of chemicals used in analysis. Certificates of Analysis and/or laboratory purity and identity confirmation for reagents and chemicals.

11. Limit of detection studies for individual methods.

12. The maintenance of accreditation and adherence to the guidelines set forth in ISO 17025:2005 as evaluated by A2LA, RMTC, ILAC, and AORC.

Industrial Laboratories maintains accurate records of samples and all processes associated with the receipt, testing, storage, and disposal of samples. Hardcopy records are maintained in secure document storage for seven (7) years. Electronic records are maintained in accordance with accreditation requirements.

The following hardcopy records relate to official samples and are available upon request:

1. Chain of Custody Form - documents individual samples, including temperature, condition of sample and packaging, integrity, seal and lock conditions, person opening the cooler or packaging and receiving samples.

2. LIMS Records – Laboratory Information Management System accessioning and tracking records that follow a sample through the testing process and sample storage areas. Records are kept of all persons handling a sample and can be printed for data packages.

3. Temperature Records - document daily temperatures of all equipment used for storage of samples.

4. Control Sample Logs - document the preparation of positive control samples, including drug identity, person preparing the control, and laboratory receipt numbers of reference materials.

5. Primary Control Number Logs - document the date of receipt for laboratory reagents and supplies, identifies person receiving supplies, storage conditions and location, expiration dates, and certificate of analysis availability.

6. Secondary Control Number Logs - document the preparation of reagents and standards, including date and person involved in the preparation, and primary control numbers of all reagents used in the preparation.

STANDARD OPERATING PROCEDURES

Standard Operating Procedures (SOP’s) are controlled documents and maintained by our Quality Department. Laboratory staff can access the most current version of all SOPs in both hardcopy and electronic form. Documents are reviewed and signed by laboratory management, who also review the documentation regularly for needed updates. Changes to documents are tracked in the document history section and previous versions of all SOP’s are archived for a minimum of seven (7) years.

SAMPLE MANAGEMENT / SAMPLE RETENTION

Upon receipt from the racetrack, samples are inspected and if deemed acceptable for testing they are registered in our Laboratory Information Management System (LIMS). Once registered, a chain of custody record is automatically created for each individual sample. This record is updated with each movement of the sample throughout the testing process. The internal chain of custody record includes which sample matrix is being accessed, by whom, when, where, and why the sample was accessed. The internal CoC is maintained from receipt through to disposal of the sample.

All testing is conducted using an aliquot from the primary sample. The primary samples are maintained in secured temperature-controlled units that are only accessible by applicable DTS employees.

Negative (passed) samples will be retained for a minimum of 90 days. During the first 30 days following sample receipt, the samples will be stored under secure refrigerated conditions, followed by storage in frozen conditions for the remaining 60 days.

Suspicious, but subsequently passed, samples will be retained for a minimum of 90 days.

During the first 30 days following sample receipt, the samples will be stored under secure refrigerated conditions, followed by storage in frozen conditions for the remaining 60 days.

Positive (failed) samples shall be retained in frozen storage for 1 year (365 days). Samples will be disposed after authorization from NRGC.

SCOPE OF TESTING

STATEMENT OF WORK TO BE PERFORMED

Industrial Laboratories agrees to maintain all necessary personnel, equipment, facilities and supplies to perform analyses on samples submitted by the Nebraska Racing and Gaming Commission.