3-Attachment B Scope of Work.docx

ATTACHMENT B - SCOPE OF WORK

The Utah Department of Agriculture and Food (the “Department”) seeks a laboratory (the “Contracted Laboratory”) to perform drug testing on samples for horse racing in Utah. Comment by Curtis Grow: Do we need to generalize this in case the Commission eventually adds non-quarter horse races in Utah? The SOW references other quarter horse specific items.

Samples taken from horses shall include blood, hair and urine, and should be tested for all drugs commonly abused by horsemen and as listed in the guidelines and schedules referenced in subsection D.3. below.

A. Overall Responsibilities The Contracted Laboratory shall:

1. Provide supplies needed to procure samples;

2. Provide instructions on handling and shipment of specimens to maintain the integrity of the samples;

3. Provide the test results within the guaranteed turnaround time;

4. Provide the results only to the Official Veterinarian and others designated by the Utah Horse Racing Commission in a secure manner;

5. Maintain the security and privacy of all samples sent; and

6. Provide all supplies required for sample collection and shipment, including:

a. Securable, insulated shipping containers of suitable size;

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

c. Ice packs and padding/absorbent fill;

d. Metal strip seals (numbered);

e. Locks (keyed);

f. Shipping labels;

g. Urine collection cups, 1 per sample, 90 mL capacity, sterile, with lids;

h. Urine specimen cups, 2 per sample, 30 mL capacity, sterile, with leak-proof caps;

i. Serum separator tubes, 3 per sample, 8 to 12.5 mL capacity;

j. Needles, multi-draw, 1 per sample, 20-gauge, 1½ inch length;

k. Needle holders;

l. Sample ID tags, sequentially numbered, barcoded, with 8 removable stickers for use on specimen;

m. Containers and paperwork, 1 per sample; and

n. Evidence tape.

The Department’s Testing Veterinarian shall:

1. Send the samples to the Contracted Laboratory.

B. Sample Retention Policies The laboratory shall retain samples as follows:

1. Testing in progress:

a. Blood and Urine

i. secure refrigerator

ii. 10 days maximum

2. Negative samples:

a. Blood

i. secure refrigerator

ii. 30 days

b. Urine

i. secure freezer

ii. 30 days

3. Suspect samples:

a. Blood and Urine

i. secure freezer

ii. 30 days

4. Positive samples:

a. Blood and Urine

i. secure freezer

ii. 1 year C. Required Systems To ensure consistently valid results, the Contracted Laboratory shall employ the following systems designed to minimize or eliminate potential invalid tests:

1. Daily tuning and/or calibration procedures of all instrumentation;

2. Preventative maintenance programs and/or service contracts to minimize breakdown of equipment or potential downtime:

a. All records related to this must be maintained for review;

3. Calibration and certification of pipettes, thermometers, and other measuring equipment;

4. Balance checks and accuracy verification;

5. Temperature monitoring of sample refrigerators and freezers;

6. The use of positive and negative matrix control samples in every analytical batch;

7. All control samples are recorded and traceable;

8. Failure of a positive control sample shall result in rejection of the batch;

9. The analysis shall be repeated, and an investigation into the failure shall be performed and documented;

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

11. 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;

12. The Contracted Laboratory shall participate in proficiency testing programs offered by the Association of Official Racing Chemists (“AORC”) and Racing Medication and Testing Consortium (“RMTC”); Comment by Curtis Grow: This association has three labs in the US listed: Industrial; TVMDL; and Truesdail Laboratories Inc. (Irvine, CA). Comment by Curtis Grow: RMTC lists six accredited labs: Industrial; UC-Davis; Ohio Dept. of Ag; EQIAS in Kentucky; New York Equine Drug Testing; and Pennsylvania Dept. of Ag.

13. Re-checks of random samples for false negative results:

a. The Contracted Laboratory shall engage in a negative sample exchange program with another racing laboratory to ensure the efficacy of screening methods;

14. Internal and External audits of laboratory operations:

a. Internal investigation procedures;

b. Corrective Action Procedures and Root Cause Analysis of all quality-related failures; and

c. Any non-compliant findings result in a Corrective and Preventive Action Report (“CAPA”) and require resolution within 30 days of the documented finding;

15. Documentation of all quality-related systems in the company Quality Manual;

16. There must be availability of written Standard Operating Procedures to all technical staff for training and reference;

17. The continuous training and education of laboratory staff is documented in individual training files;

18. Obtaining quality supplies from reputable vendors;

19. Validating all reference standards used in analysis;

20. Maintaining a documented control system for all chemicals, reagents, standards, etc., to ensure traceability of chemicals used in analysis:

a. Including Certificates of Analysis and/or laboratory purity and identity confirmation for reagents and chemicals;

21. Limit of detection studies for individual methods; and

22. The maintenance of accreditation and adherence to the guidelines set forth in ISO 17025:2017 as evaluated by A2LA, RMTC, ILAC, and AORC. Comment by Curtis Grow: I believe this has been updated to ISO “17025:2017.”

D. Blood and Urine Samples The Contracted Laboratory shall:

1. Target test every blood and urine sample for a comprehensive drug panel that includes the Thoroughbred Owners and Breeders Association (“TOBA”) mandatory and optional drug candidates, all Association of Racing Commissioners International (“ARCI”) Controlled Therapeutic Substances, environmental contaminants and relevant doping agents using a custom target analysis by LC-MS/MS that is a sensitive, accurate, and precise determination of the compounds that occur routinely in racing, as well as drugs that are potent performance enhancers. Comment by Curtis Grow: I’m guessing this is the Thoroughbred Owners and Breeders Association. I cannot find a copy of the current list for these drugs on its website. If it is this association – it may be only available to members.

2. Urine samples shall be both base and enzyme hydrolyzed prior to extraction. There shall be no rotation of routine coverage – it shall be performed on every sample submitted.

3. Included in the routine screen are:

a. All ARCI and RMTC Controlled Therapeutic Medications, including: Comment by Curtis Grow: The following are listed on the ARCI list and the RMTC list, but do not appear on this list: Cetirizine; Cimetidine; Dantrolene; and Detomidine.

i. Acepromazine and metabolite, 2-1-hydroxyethylpromazine sulfoxide;

ii. Albuterol;

iii. Betamethasone;

iv. Butorphanol;

v. Cetirizine;

vi. Cimetidine;

vii. Clenbuterol;

viii. Dantrolene;

ix. Detomidine;

x. Dexamethasone;

xi. DMSO;

xii. Furosemide;

xiii. Glycopyrrolate;

xiv. Guaifenesin;

xv. Isoflupredone;

xvi. Lidocaine and metabolites, 3-hydroxylidocaine and monoethylglycinexylidide;

xvii. Mepivacaine and metabolite, hydroxy mepivacaine;

xviii. Methocarbamol;

xix. Methylprednisolone;

xx. Omeprazole sulfide;

xxi. Prednisolone;

xxii. Procaine penicillin;

xxiii. Ranitidine;

xxiv. Triamcinolone acetonide;

xxv. Xylazine and metabolite;

xxvi. Flunixin;

xxvii. Ketoprofen; and xxviii. Phenylbutazone.

b. All TOBA Mandatory Drugs: Comment by Curtis Grow: Same comment as above on the Thoroughbred Owners and Breeders Association.

i. RCI Class 1 Drugs: (18 mandatory drugs): alfentanil, amphetamine, apomorphine, carfentanil, benzoylecgonine, morphine, dermorphin, etorphine, despropionylfentanyl, hydromorphone, levorphanol, meperidine, normeperidine, mephentermine, methamphetamine, ritalinic acid, oxymorphone, and sufentanil (plus 30 other Class 1 drugs);

ii. RCI Class 2 Drugs: (25 mandatory drugs): nortriptyline, buprenorphine, buspirone, caffeine, meprobamate, hydroxy carisoprodol, chlorpromazine, desipramine, dezocine, nordiazepam, oxazepam, temazepam, ephedrine, phenylpropanolamine, fluoxetine, fluphenazine, desipramine, lidocaine, mepivacaine, modafinil, nalbuphine, nalorphine, nortriptyline, propionylpromazine, and tramadol (plus 52 other Class 2 drugs);

iii. RCI Class 3 Drugs: (43 mandatory drugs): acepromazine, albuterol, boldenone, bumetanide, butorphanol, clenbuterol, cobalt, deracoxib, detomidine, etodolac, fenoprofen, flufenamic acid, flurbiprofen, formoterol, furosemide, gabapentin, glycopyrrolate, guanabenz, ipratropium, ketorolac, metaproterenol, methyltestosterone, metoprolol, nabumetone, nandrolone, pentazocine, phenylpropanolamine, pirbuterol, piroxicam, procaine, promazine, propranolol, pyrilamine, ractopamine, sildenafil, stanozolol, tenoxicam, terbutaline, testosterone, tetrahydrogestrinone, theophylline, trenbolone, xylazine (plus 41 other Class 3 drugs); and

iv. RCI Class 4 Drugs: (19 mandatory drugs): betamethasone, dantrolene, dexamethasone, diclofenac, diflunisal, firocoxib, flumethasone, flunixin, ibuprofen, isoflupredone, ketoprofen, meclofenamic acid, methocarbamol, methylprednisolone, naproxen, phenylbutazone, prednisolone, prednisone, triamcinolone acetonide (plus 28 other Class 4 drugs).

E. The Contracted Laboratory shall

1. Prepare quantitative control samples, so that the lab can obtain an estimated level of any threshold drug that is present in the screening test. Samples that appear to be greater than the permitted threshold are marked for re-analysis using specific, quantitative methods. Samples that contain these medications at levels below the threshold can be reported back to designated Commission contacts for research purposes.

2. Monitor every blood sample for the presence of furosemide and an estimated level can be determined based on screening test data to allow for efficient detection of threshold violations. Any sample from a horse entered on furosemide that appears to have a level greater than the official threshold of furosemide is marked for re-analysis and submitted for confirmatory testing, including specific gravity testing to verify urine dilution. Horses not entered on furosemide, but suspect for its presence, shall be confirmed and reported as a violation.

3. Test every blood sample for the following corticosteroids on a routine basis: betamethasone, dexamethasone, flumethasone, isoflupredone, methylprednisolone, triamcinolone acetonide, prednisolone, and prednisone, as well as other corticosteroid drugs which are not permitted at any level.

F. Hair Testing The Contracted Laboratory shall:

1. Adhere to AQHA Protocol Comment by Curtis Grow: Here are a couple of links to information on hair testing on AQHA. https://www.aqha.com/-/hair-testing and https://www.aqha.com/-/hair-testing-meeting?inheritRedirect=true

I could not find a copy of the standards or protocol that the links mention. Industrial, TVMDL, and UC-Davis were the three labs attending the meetings where the AQHA decided to standardize these.

G. Price List Please include a price list for blood, urine, and hair tests.

Attachment B - Scope of Work Page 2 of 2