welcome manual - Castle Medical
Transcription
welcome manual - Castle Medical
WELCOME MANUAL molecular diagnostics | toxicology services CEO A WELCOME MESSAGE FROM OUR Welcome to the Castle Family! I would first like to take a moment to personally thank you for choosing Castle Medical as your wellness partner. We promise to do everything in our power to make sure that this is the best decision you have ever made. As a world-class healthcare organization we provide exceptional service and strive to deliver a superior quality of care. Although we understand that anyone can say this, the reality is that we back it up. Since our inception in 2004, our goal and vision has never waned; to bring truth and common sense to healthcare. While we are closer to realizing this goal more than we were yesterday, there is still a long way to go to bring about real change to the healthcare industry. Castle Medical was founded on the belief that if you follow a positive pattern of behavior, your results will always be consistent with your output. With this in mind, we implore all of our employees to follow our canons; be authentic, be creative, be accountable, be fun, be thankful, be of service, take action, be tenacious. If you ever feel that any of our employees are not acting with one of these in mind, please let us know and we will take action immediately. We aspire to be the most innovative, customer-centric, moving at the speed-of-light organization, while never losing sight of our origins. Our team is aligned to inspire real change and we are extremely excited that you will be a part of our vision to overhaul the healthcare system, one happy patient at a time. Finally, it is no secret that we are an award winning company with an award winning attitude. Most recently we were honored by Inc. Magazine as the #1 Fastest Growing Healthcare Organization on their annual Inc. 5000 list. We have also been recognized by The Atlanta Journal-Constitution as Atlanta’s Top Workplaces, as well as received other prestigious awards for which we are both honored and proud to have hanging on our walls. What this tells us is that while our employees love working for us, just as importantly, our customers love working with us. Warmest regards, Scott M. Damron 1 CASTLE MEDICAL Corporate Contact Information , LLC Main Number: 678-486-7340 Toll Free: 855-8CASTLE Fax Number: 678-486-7350 Toll Free: 855-9CASTLE Laboratory - [email protected] Chief Toxicologist Thomas David Lead Toxicologist (Urine) (227853) (227853) DEPARTMENTS 678-486-7340 ext 604 [email protected] Yan Zou, Ph.D. 678-486-7340 ext 611 [email protected] Lead Toxicologist (Blood/Saliva) Rahul Nahire, Ph.D. 678-486-7340 ext 618 [email protected] Lead Geneticist (DNA) Alex Schmidt 678-486-7340 ext 641 [email protected] Molecular Biologist Varsha Meghnani, Ph.D. 678-486-7340 ext 657 [email protected] General Counsel: Scott Damron 678-486-7340 ext 606 [email protected] General Operations: Jennifer Blair 678-486-7340 ext 603 [email protected] Marketing & Design: Daniel Battaglia 678-486-7340 ext 621 [email protected] Client Billing: Gina Stieber Sue Mayberry Lucy Perkins 678-486-7340 ext 627 678-486-7340 ext 632 678-486-7340 ext 609 [email protected] [email protected] [email protected] Analyzer: Charles Minando 678-486-7340 ext 610 [email protected] IT Support: Alisa Bucy 678-486-7340 ext 631 [email protected] Management & Operations Client Service Representative by State: Saeeda Bah 678-486-7340 ext 644 [email protected] Isaiah Wilson 678-486-7340 ext 612 [email protected] Rose Butt AR, IA, IL, IN, KS, LA, MI, MN, MO, MS, NE, OH, OK 678-486-7340 ext 634 [email protected] Kathryn Brown 678-486-7340 ext 626 [email protected] AL, CT, DE, DC, KY, MA, ME, MD, NC, NH, NJ, NY, PA, RI, TN, VA, VT, WV FL, GA, SC AZ, CA, CO, ID, MT, ND, NM, NV, OR, SD, TX, UT, WA, WI, WY 2 OUR COMPREHENSIVE SERVICES Toxicology Services Departments Include: 1. Pain Management 2. Work-Place Drug Testing 3. Forensic Toxicology 4. Therapeutic Drug Monitoring Castle Medical has committed itself to fully serve the pain management specialty area with state-of-the art toxicology labs headquartered in Atlanta, Georgia. While our focus is on drugs of abuse testing, our duty is to physicians and their patients, and although we have put together the industry’s most comprehensive and functional testing panels, we offer a plethora of toxicology testing services from which physicians may choose in order to tailor programs to their patients’ specific needs. With expert staffing and premium toxicology services, our scientific testing laboratories provide fast and accurate results for submitted specimens. Departments Include: 1. Pharmacogenetics 2. Genetics 3. Oncology 4. Infectious Diseases Molecular Diagnostics CORE DME: (Pharmacogenetics) Our Core DME panel tests for genes affecting the metabolism of several classes of drugs. The tested genes include: CYP2D6, CYP2C9, CYP2C19, CYP2B6, CYP3A4, and CYP3A5. In addition to this, other genes like OPRM1, SLCO1B1 and COMT which contribute to drug response and clearance are also tested in this panel.This panel will provide prescribers critical information regarding a patient’s metabolic phenotype. The metabolic rate of an individual in terms of TCAs, opiates, oncological, cardiovascular, and psychotropic drugs may be ascertained and the most effective dosage may be prescribed for optimal therapeutic use. Chemo DME: (Pharmacogenetics) This panel tests for the TPMT, DPYD, and UGT1A1 genes. These genes are responsible for the body’s metabolism of several commonly prescribed chemotherapeutic drugs. Utilizing this panel will enhance a physician’s ability to predict adverse side effects that range from diarrhea to organ failure and facilitate the optimal, targeted personalized therapy for oncological purposes. Warfarin: (Pharmacogenetics) This panel is designed exclusively to test for genes associated with warfarin, also known as Coumadin, response. The genes included are VKORC1, GGCX, CYP4F2, and CACNA1C. The results can help assess the best dosage for a patient in order to prevent severe risk and side effects to the patient. This provides physicians with the means to provide targeted therapy based on individualized, genetic information. MTHFR and Homocysteinemia: (Genetics) MTHFR gene encodes for methylenetetrahydrofolate reductase enzyme that plays a critical role in vitamin-B, folate and homocysteine (a potentially toxic amino acid) metabolism. Genetic variations in the MTHFR gene can cause the enzyme to work less efficiently and can lead to elevated homocysteine levels. Enhanced plasma homocysteine has been identified as a risk factor for occlusive disease in the coronary, cerebral and peripheral arteries and for venous thrombosis. It has also been related to the occurrence of neural tube defects and other pregnancy complications. Such genetic variations are common - around 12% of Caucasians are affected by just one of the many possible MTHFR variants. In addition to the MTHFR genetic test, we also offer a blood test to detect elevated homocysteine levels as a confirmatory test for MTHFR functional deficiency. BRCA Variant Testing: (Oncology) - Coming Soon BRCA1 and BRCA2 are tumor suppressor genes, which means that they help repair DNA damage and destroy cells with irreparable DNA before they can become cancerous. People with non-functional variants of BRCA1 or BRCA2 are at an increased risk of developing several types of cancer - especially breast and ovarian cancer. Knowledge of a patient’s BRCA1/2 status can help them make preventative choices, as was the case with Angelina Jolie’s double mastectomy. Durable Medical Equipment Our Durable Medical Equipment (DME) company, Drawbridge Medical specializes in supporting pain physicians with the industry’s best braces, pumps and other products to empower patients’ to live again. With our no-hassle, all reward guarantee we’re confident patients will feel the difference. Castle Billing Solutions A billing solutions service that provides financial benefits to every physician. 3 BILLING COMING SOON! DRUGS WE TEST FOR CURRENT TOTAL: 120+ THE COMPREHENSIVE PANEL THE FOLLOWING IS AVAILABLE IN 4 DRUGS WE TEST FOR CURRENT TOTAL: 120+ 5 THE COMPREHENSIVE PANEL THE FOLLOWING IS AVAILABLE IN DRUGS WE TEST FOR CURRENT TOTAL: 120+ THE COMPREHENSIVE PANEL THE FOLLOWING IS AVAILABLE IN 6 DRUGS WE TEST FOR CURRENT TOTAL: 120+ THE COMPREHENSIVE PANEL THE FOLLOWING IS AVAILABLE IN 7 DRUGS WE TEST FOR 4-OH Phenytoin 6-MAM (Heroin) 6-β-Naltrexol 7-OH-Mitragynine 25I-NBOMe Actiq (Fentanyl) Adderall (Amphetamine) Alpha PVP Alprazolam (4-HydroxyAlprazolam) Ambien (Zolpidem) Amitriptyline Amphetamine Aricept (Donepezil) Ativan (Lorazepam) Avinza (Morphine) Benzoylecgonine (Cocaine) Buprenex (Buprenorphine) Buprenorphine Butalbital Carisoprodol Chlordiazepoxide (Librium) Clonazepam (7-AminoClonazepam) Cocaine (Benzoylecgonine) Codeine Cognex (Tacrine) Concerta (Methylphenidate) Cotinine (Nicotine) Cyclobenzaprine (Flexeril) D-Methamphetamine D-Amphetamine Dalmane (HydroxyethylFlurazepam) Darvocet (Propoxyphene) Darvon (Propoxyphene) Demerol (Meperidine) Desoxyn (Methamphetamine) Dexedrine (Amphetamine) Diazepam Dilaudid (Hydromorphone) Dilantin (Phenytoin) Dihydrocodeine (Trezix) Dolophine (Methadone) Donepezil (Aricept) Duragesic (Fentanyl) Duramorph (Morphine) Ecstasy (MDMA) Elavil (Amitriptyline) Endocet (Oxycodone) Ethyl Glucuronide Ethyl Sulfate Exalgo (Hydromorphone) Exelon (Rivastigmine) Fentanyl Fentora (Fentanyl) Fioricet (Butalbital) Fiorinal (Butalbital) Flexeril (Cyclobenzaprine) Flurazepam (HydroxyethyFlurazepam) Gabapentin (Neurontin) Halcion (Triazolam) Heroin (6-MAM) A-Z Hydrocet (Hydrocodone) Hydrocodone Hydromorphone Hydrostat IR (Hydromorphone) HydroxyethyFlurazepam (Flurazepam) JWH-018 -Synthetic Cannabinoids (K2/Spice) JWH-073-Synthetic Cannabinoids (K2/Spice) Kadian (Morphine) Klonopin (Clonazepam) Kratom (Mitragynine) L-Methamphetamine L-Amphetamine Librium (Chlordiazepoxide) Lacosamide Lorazepam Lorcet (Hydrocodone) Lortab (Hydrocodone) Lunesta (Zopiclone/Eszopiclone) Lyrica (Pregabalin) Marijuana (THCA) Maxidone (Hydrocodone) MDMA (Ecstasy) MDPV (Methylenedioxypyrovalerone) Memantine (Namenda) Meperidine Meprobamate (Miltown) Methadone Methadose (Methadone) Methamphetamine (Desoxyn) Methylone Methylone-Cathinones Methylphenidate Midazolam (Versed) Miltown (Meprobamate) Mitragynine (Kratom) Morphine MMC (Mephedrone) MS Contin (Morphine) MSIR (Morphine) Naloxone Namenda (Memantine) Neurontin (Gabapentin) Nicotine Norco (Hydrocodone) Norcodeine Norhydrocodone Normorphine Noroxycodone Nordiazepam Nortriptyline Nucynta (Tapentadol) Numorphan (Oxymorphone) Opana (Oxymorphone) Oramorph (Morphine) Oxazepam Oxy IR (Oxycodone) Oxycodone Oxycontin (Oxycodone) Oxymorphone PCP Percocet (Oxycodone) Percodan (Oxycodone) Percolone (Oxycodone) Phenobarbital Phenytoin (Dilantin) Pregabalin (Lyrica) Propoxyphene Quetiapine (Seroquel) Ranitidine (Zantac) Reprexain (Hydrocodone) Restoril (Temazepam) Ritalin (Methylphenidate) Rivastigmine (Exelon) Rohypnol (Flunitrazepam) Roxanol (Morphine) Roxicodone (Oxycodone) Serax (Oxazepam) Seroquel (Quetiapine) Sertraline (Zoloft) Soma (Carisoprodol) Sonata (Zaleplon) Suboxone (Buprenorphine/ Naloxone) Subutex (Buprenorphine) Tacrine (Cognex) Tapentadol (Nucynta) Temazepam THCA (Marijuana) Tramadol Trezix (Dihydrocodeine) Triazolam (Halcion) Tussionex (Hydrocodone) Tylenol #3 (Codeine) Tylenol #4 (Codeine) Ultracet (Tramadol) Ultram (Tramadol) Valium (Diazepam) Versed (Midazolam) Vicodin (Hydrocodone) Vicoprofen (Hydrocodone) Xanax (4-HydroxyAlprazolam) Zaleplon (Sonata) Zantac (Ranitidine) Zohydro (Hydrocodone) Zoloft (Sertraline) Zolpidem (Ambien) Zolpidem Phenyl COOH Zonisamide Zopiclone/Eszopiclone (Lunesta) A-Z NOTE: Our testing capabilities are always expanding. Please check with your representative if a specific drug is not listed here as it may have recently been added to our list of drugs. 8 NEW REQUISITION FORM N649601 N649601 PLACE OVER CAP OF SPECIMEN DATE: ___________ COLLECTOR INITIALS: ___________ TIME: ___________ PATIENT INITIALS: ___________ 1 2 CASTLE MEDICAL, LLC 5700 Highlands Parkway, Suite 100 Smyrna, Georgia 30082 phone: 678-486-7340 toll free: 855-822-7853 fax: 678-486-7350 toll free: 855-922-7853 email: labsupport @ c a s t l e m e d i c a l . c o m REQUESTING PHYSICIAN 6 PATIENT INFORMATION MEDICAL NECESSITY : ICD-9 DIAGNOSIS CODES Last: ______________________________ First: ________________________________ MI: ______ S. S. # : __________________________ D.O.B. ______ /______ /________ SEX: M F Address: _________________________________________________________ See Attached City: ____________________________ State: _____________ Zip Code: ___________________ Phone: (____) ________ - ___________ Email: _________________________________________ ____ The information I have provided on this form is accurate. I authorize Castle Medical to release the results of this testing to the treating physician or facility. I hereby authorize my insurance or other payment benefits to be paid directly to Castle Medical for services I received. I acknowledge that Castle Medical may be an out-of-network provider with my insurer. I am also aware that in some circumstances my insurer might send the payment directly to me. I agree to endorse the insurance check and forward to Castle Medical within fifteen days of receipt. I acknowledge that I am responsible for all co-pays and deductibles not covered by insurance or other payors. Patient Signature: ____________________________________ Date: _________________ _ 3 PRIMARY INSURANCE INFORMATION a 8 SELF PAY: 9 723.1 729.1 V58.69 OTHER OTHER OTHER Physician Signature: ________________________________ Date: ____ /____ /______ I hereby authorize the laboratory tests selected below and acknowledge that the test(s) ordered are medically necessary. 7 SPECIMEN SOURCE D&L ISOMERS BATH SALTS (urine only) BUPRENORPHINE COCAINE _____________________________ ETG / ETS (Alcohol Metabolite) (urine only) _____________________________ MARIJUANA _____________________________ METHADONE No Drugs Prescribed See Attached MUSCLE RELAXANTS POINT-OF-CARE RESULTS POS (+) NICOTINE (urine only) 5 OXYCODONE BARBITURATES (BAR) PHENCYCLIDINE BENZODIAZEPINES (BZO) PROPOXYPHENE BUPRENORPHINE (BUP) SYNTH. CANNABINOIDS COCAINE (COC) TRICYCLICS Z-DRUGS ECSTACY (MDMA) MARIJUANA (THCA) c 8 PROPOXYPHENE (PPX) (PXP) TRICYCLIC ANTIDEPRESSANTS (TCA) Temperature must be read within 4 minutes and fall between the range of 32.5 - 37.7 ºC (90.5 - 98.8 ºF). Results outside range check this box. SALIVA x x x (K2 | SPICE) (urine only) x x MODERATE x x x x x x x x x x x x x x x x x x x LOW x CUSTOM x x x x x x x x x x x PRE-CUSTOMIZED PANELS OPIATES (OPI) (MOP) PHENCYCLIDINE (PCP) BLOOD b 8 METHADONE (MTD)(MAD) OXYCODONE (OXY) x x x x x x x OPIATES - NEG ( ) AMPHETAMINE (AMP) HIGH x x x BENZODIAZEPINES _____________________________ URINE REQUESTED TEST(S) : QUANTITATIVE CONFIRMATION OF DRUGS BY LC/MS/MS BARBITURATES CURRENT MEDICATIONS : SHADE ALL THAT APPLY Methylphenidate Morphine MS-Contin MSIR Neurontin Norco Norephedrine Nortriptyline Nucynta Opana Oxazepam Oxycodone OxyContin Oxy IR Oxymorphone Percocet Phenobarbital Phentermine Plegine Pregabalin PPA Restoril Ritalin Roxicodone Serax Sertraline Soma Sonata Suboxone Subutex Sudafed Tapentadol Temazepam Tramadol Tylenol #3, #4 Ultram Valium Vicodin Vicoprofen Vick’s Inhaler Xanax Zolpidem 719.41 ANTIEPILEPTICS Member ID # : __________________________ Group ID #: _____________________ Adderall Adipex Alprazolam Ambien Amitriptyline Ativan Buprenorphine Butalbital Carisoprodol Clonazepam Codeine Cyclobenzaprine Dalmane Demerol Desipramine Desoxyn Dexedrine Diazepam Didrex Dilaudid Dolophine Duragesic Elavil Endocet Ephedrine Fentanyl Flexeril Fioricet Flunitrazepam Flurazepam Gabapentin Hydrocodone Hydromorphone Imipramine Kadian Klonopin Lorazepam Lortab Lunesta Lyrica Meperidine Methadone 724.5 Medical necessity is defined as accepted health care services and supplies provided by health care entities, appropriate to the evaluation and treatment of a disease, condition, illness or injury and consistent with the applicable standard of care. AMPHETAMINES CLIENT BILL: Insurance Company Name: ____________________________ See Attached 4 724.4 Check One: COMPREHENSIVE PANEL REQUIRED: ENCLOSE A COPY OF THE FRONT & BACK OF PATIENT’S INSURANCE CARD(S) INSURANCE: 724.2 _____________________________________________ ____________________________________________ _____________________________________________ ____________________________________________ REQUESTED TEST(S) NOT LISTED _____________________________________________ ____________________________________________ _____________________________________________ ____________________________________________ d 8 ADDITIONAL TESTING OPTIONS White - Castle Copy Yellow - Physician Copy URINE SCREENING Pink - Patient Copy URINE VALIDITY V1.0 NEW REQUISITION FORM CHEAT SHEET N649601 CASTLE MEDICAL, LLC 5700 Highlands Parkway, Suite 100 Smyrna, Georgia 30082 ___________ ___________ STEP 2.1 PEEL STICKER. PLACE OVER CONTAINER PLACE OVER Make sure to have Patient Initial and then Sign under Patient Signature N 649601 CAP OF CUP ___________ ___________ DATE: COLLECTOR INITIALS: phone: 678-486-7340 toll free: 855-822-7853 fax: 678-486-7350 toll free: 855-922-7853 email: labsupport@ c a s t l e m e d i c a l . c o m PATIENT INITIALS: (See STEP 2) at the same time. Peel sticker and place over specimen. TIME: 1 REQUESTING PHYSICIAN STEP 1. REQUESTING PHYSICIAN Relates to patient/test Please check the appropriate name(s) of the physician(s) requesting the test(s). Relates to physician/order LabForms 888-200-5114 2 6 REQUIRED: ENCLOSE A COPY OF THE FRONT & BACK OF PATIENT’S INSURANCE CARD(S) MEDICAL NECCESITY - ICD DIAGNOSIS CODES STEP PATIENT INFORMATION (ITEMS IN RED ARE REQUIRED) PATIENT 2. INFORMATION STEP 6. ICD-9 DIAGNOSIS CODES Last: __________________________ First: _________________________ Middle A. Last Name B. First Name C. Social Security # Initial: _______ In order to prove medical necessity the physician 729.1 V58.69 OTHER OTHER must provide a reason for why the test is being performed. S. S. # : __________________________ D. Date of Birth E.D.O.B. Sex ______/______/________ SEX: M 724.2 F Address: _________________________________________________________ See Attached Physician Signature: _______________________________ Date: ___ /____ /______ G. Phone & Email Address H. Patient Signature & Date (See STEP 2.1 ABOVE) Patient Signature: ___________________________________________ Date: _________________________ appropriate specimen source (Urine, Blood or Saliva). PANEL HIGH TEST(S) MODERATE STEPCOMPREHENSIVE 8a. REQUESTED AMPHETAMINES x x BARBITURATES x x BENZODIAZEPINES x x LOW x CUSTOM x D&L ISOMERS If a quantitative confirmation test is being requested we have a x x ANTIEPILEPTICS few options for the physician to choose from: Member ID # : __________________________ Group ID #: _____________________ CURRENT MEDICATIONS STEP Actiq 4. CURRENT Lorazepam MEDICATIONS Temazepam Vicodin Lorcet Adderall Tramadol Vicoprofen Lortab Adipex Tylenol #3 Vick’s Inhaler Please shade in (be sure to fill entire bubble provided) Lunesta Xanax Alprazolam Tylenol #4 Lyrica ________________ Ambien Ultracet ALL MEDICATIONS currently prescribed to patient. If _a___specific Maxidone ____________________ Amitriptyline Ultram medication is not available please checkValium blank boxes and Meperidine ____________________ Ativan Avinza medication. Methadone write-in No Drugs Prescribed Methylphenidate Buprenex Morphine See Attached Buprenorphine MS-Contin Butalbital If No Prescriptions have been 5 MSIR Carisoprodol POINT-OF-CARE RESULTS prescribed please check the Neurontin Clonazepam POS (+) NEG (-) Norco Codeine “NO DRUGS PRESCRIBED” AMPHETAMINE (AMP) Norephedrine Cyclobenzaprine box. Nortriptyline Dalmane BARBITURATES (BAR) Nucynta Darvon BENZODIAZEPINES (BZO) Numorphan Demerol If you have obtainedOpana a copy of the Please check the results of Desipramine ALL TESTED DRUGS from BUPRENORPHINE (BUP) DesoxynMedicationOramorph patient’s List, you can Oxazepam Dexedrine the Point-of-Care cup test. attach it to the requisition form COCAINE (COC) Oxycodone Diazepam OxyContin Dilaudid and select “SEE ATTACHED.” ECSTACY (MDMA) Oxy IR Dolophine Oxymorphone Duragesic MARIJUANA (THCA) Percocet Duramorph EXAMPLES: Percodan Elavil METHADONE (MTD)(MAD) Percolone Embeda Adderall - ACCEPTABLE Phenobarbital Endocet OPIATES (OPI) Phentermine Ephedrine Adderall - NOT ACCEPTABLE Pregabalin Fentanyl OXYCODONE (OXY) Adderall - NOT ACCEPTABLE TEMPERATURE READING PPA Fentora Restoril Flexeril Adderall - NOT ACCEPTABLE IfPHENCYCLIDINE sample is(PCP) outside of range Ritalin Fioricet please be sure to check the Roxanol Fiorinal PROPOXYPHENE (PPX) (PXP) Roxicodone Flunitrazepam box provided below. Serax Flurazepam TRICYCLIC ANTIDEPRESSANTS (TCA) Sertraline Gabapentin Soma Hydrocodone Temperature must be read within 4 Sonata Hydromorphone minutes and fall between the range Suboxone Hydrostat IR of 32.5 - 37.7 ºC (90.5 - 98.8 ºF). Subutex Imipramine Results outside range check this box. Sudafed Kadian Tapentadol Klonopin a test please be sure toBLOOD check the SALIVA STEP 7 Before SPECIMEN SOURCE: URINE REQUESTED TEST(S)selecting URINE QUANTITATIVE CONFIRMATION OF DRUGS BY LC/MS/MS INSURANCE: SELF CLIENT BILL: B. INSURANCE: Patient’s insurance provider will bePAY: billed for services rendered C. SELF PAY: Patient will be billed directly by Castle Medical Insurance Company Name: _____________________________________________ D. CLIENT BILL: Clinic will be billed directly by Castle Medical WC/AUTO/LOP: 4 723.1 OTHER I hereby authorize the laboratorydefault tests selected below and acknowledge the test(s) We have provided common codes,thatbut theyordered are medically necessary. should only be selected if/when they match the medical record for the patient. The information I have provided on this form is accurate. I authorize Castle Medical to release the results of this testing to the treating physician or facility. I hereby authorize my insurance or other payment benefits to be paid directly to Castle Medical for services I received. I acknowledge that Castle Medical may be an out-of-network provider with my insurer. I am also aware that in some circumstances my insurer might send the payment directly to me. I agree to endorse the insurance check and forward to Castle Medical within fifteen days of receipt. I acknowledge that I am responsible for all co-pays and deductibles not covered by insurance or other payors. 7 719.41 medical record. Phone: (____) ________ - ___________ Email: _________________________________________ ____ 3 724.5 Medical necessity is defined as accepted health care services and supplies provided by health care entities, appropriate to the evaluation and treatment of a disease, condition, illness or injury and consistent withprovided the applicableinstandard of care. Please be sure to use the code the patient’s F. Address: If you leave this area blank you must check “See City: ____________________________ State: _____________ Zip Code: ___________________ Attached” and provide Demographic Documentation PRIMARY INSURANCE INFORMATION STEP 3. INSURANCE INFORMATION 724.4 Comprehensive Panel: The comprehensive panel is available for x BATH SALTS the most common drugs ordered. x x BUPRENORPHINE High Risk Patient: A full panel of drugs tested.x x COCAINE x Moderate Risk Patient: A less conservative comprehensive panel. x ETG / ETS (Alcohol Metabolite) MARIJUANA Low Risk STEP 5. POC RESULTS Patient: A basicx x panel of commonly prescribed drugs. METHADONE x x x x OPIATES x x x x OXYCODONE x x x x PHENCYCLIDINE x x PROPOXYPHENE x x x x Custom Panel: If the physician/clinic would like to create (or has a x x x MUSCLE RELAXANTS custom panel on file) please check the select which drugs are being x NICOTINE requested for the custom panel under the CUSTOM section. x SYNTH. CANNABINOIDS (K2 | SPICE) 8 TRICYCLIC ANTIDEPRESSANTS x x Z-DRUGS x x ADD TO PANEL REQUESTED TEST(S) NOT LISTED TEST(S) STEP 8. ADDITIONAL STAND-ALONE _____________________________________________ ____________________________________________ _____________________________________________ ____________________________________________ 8b: Pre-Customized Panels: Select from your customized panels. ADDITIONAL TESTING OPTIONS 8c: Requested Tests Not HORMONES d SCREENING Listed: Order test(s) not listed onVALIDITY req. form. / Urine Validity 8 : Urine Screening EPITESTOSTERONE PROGESTERONE ALDOSTERONE VITAMIN D DHEA DHEA-S ESTRADIOL ESTRIOL FREE TESTOSTERONE _____________________________________ White - Castle Copy Yellow - Physician Copy TSH TOTAL TESTOSTERONE T3 T4 FREE T3 _____________________________________ Pink - Patient Copy V1.0 10 RECOMMENDED PAIN MANAGEMENT CODES Pain Management ICD-9 Codes Backache NOS - 724.5 Brachial Neuritis NOS - 723.4 Carpal Tunnel Syndrome - 354 Cervicalgia - 723.1 Joint Pain – Lower Leg - 719.46 Spasm of Muscle - 728.85 Lumbar Disc Displacement - 722.10 Lumbosacral/Thoracic Neuritis NOS - 724.4 Lumbosacral Spondylosis - 721.3 Myalgia and Myositis NOS - 729.1 Pain in Limb - 729.5 Poslaminect Synd-Lumbar - 722.83 Lumb/Lumbosac Disc D - 722.52 Lumbago - 724.2 Spinal Stenosis-Limbar - 724.02 Therapeutic Drug Monitor - V58.83 The following ICD-9 codes (categories 303, 304 and 305) require a fifth-digit sub-classification. The fifth-digits are as follows: 0 – unspecified 1 – continuous 2 – episodic 3 – in remission Pain Management ICD-10 Codes Additional descriptive codes available. Refer to your ICD-10 book for proper coding. M54.89 - Other dorsalgia M54.9 - Dorsalgia, unspecified M54.12 - Radiculopathy, cervical region M54.13 - Radiculopathy, cervicothoracic region G56.00 - Carpal tunnel syndrome, unspecified upper limb M54.2 - Cervicalgia M25.569 - Pain in unspecified knee M62.40 - Contracture of muscle, unspecified site M62.838 - Other muscle spasm M51.26 - Other intervertebral disc displacement, lumbar region M51.27 - Other intervertebral disc displacement, lumbosacral region M54.14 - Radiculopathy, thoracic region M54.15 - Radiculopathy, thoracolumbar region M54.16 - Radiculopathy, lumbar region M54.17 - Radiculopathy, lumbosacral region M47.817 - Spondylosis without myelopathy or radiculopathy, lumbosacral region M60.9 - Myositis, unspecified M79.1 - Myalgia M79.7 - Fibromyalgia M79.609 - Pain in unspecified limb M96.1 - Postlaminectomy syndrome, not elsewhere classified M51.36 - Other intervertebral disc degeneration, lumbar region M51.37 - Other intervertebral disc degeneration, lumbosacral region M54.5 - Low Back Pain M48.06 - Spinal Stenosis, Lumbar Region Z51.81 - Encounter for therapeutic drug level monitoring RECOMMENDED ABUSE DEPENDENCY CODES Acute Alcohol Intoxication - 303.0 Other and Unspecified Alcohol Dependence - 303.9 Opioid Type Dependence - 304.0 Sedative, Hypnotic or Anxiolytic Dependence -304.1 Cocaine Dependence - 304.2 Amphetamine and other Psychostimulant Dependence - 304.4 Hallucinogen Dependence - 304.5 Other Specified Drug Dependence - 304.6 Combinations of Opioid Type Drug with any other drug dependence - 304.7 Combinations of Drug Dependence Excluding Opioid Type Drug - 304.8 Unspecified Dependence - 304.9 Alcohol Abuse - 305.0 Cannabis Abuse - 305.2 Hallucinogen Abuse - 305.3 Sedative, Hypnotic or Anxiolytic Abuse - 305.4 Opioid Abuse - 305.5 Cocaine Abuse -305.6 Amphetamine or Related Acting Sympathomimetic Abuse -305.7 Antidepressant Type Abuse - 305.8 Other Mixed or Unspecified Drug Abuse -305.9 11 F10.229 - Alcohol dependence with intoxication, unspecified F10.20 - Alcohol dependence, uncomplicated F10.21 - Alcohol dependence, in remission F11.20 - Opioid dependence, uncomplicated F11.21 - Opioid dependence, in remission F13.20 - Sedative, hypnotic or anxiolytic dependence, uncomplicated F13.21 - Sedative, hypnotic or anxiolytic dependence, in remission F14.20 - Cocaine dependence, uncomplicated F14.21 - Cocaine dependence, in remission F15.20 - Other stimulant dependence, uncomplicated F15.21 - Other stimulant dependence, in remission F16.20 - Hallucinogen dependence, uncomplicated F16.21 - Hallucinogen dependence, in remission F19.20 - Other psychoactive substance dependence, uncomplicated F19.21 - Other psychoactive substance dependence, in remission F10.10 - Alcohol abuse, uncomplicated F12.10 - Cannabis abuse, uncomplicated F12.90 - Cannabis use, unspecified, uncomplicated F16.10 - Hallucinogen abuse, uncomplicated F13.10 - Sedative, hypnotic or anxiolytic abuse, uncomplicated F11.10 - Opioid abuse, uncomplicated F14.10 - Cocaine abuse, uncomplicated F15.10 - Other stimulant abuse, uncomplicated F19.10 - Other psychoactive substance abuse, uncomplicated F18.10 - Inhalant abuse, uncomplicated The above ICD-10 codes might require a 6th additional character. Refer to your ICD-10 book for proper coding. URINE SPECIMEN CUP SAMPLE INSTRUCTIONS 1. Tighten the lid of the specimen container. It will make a CLICK sound when tightened. Please make sure there is at least 30 mL of urine in the container. NOTE: Failure to obtain this minimum requirement will result in a rejected sample. 2. Place a label from the requisition form over the top of the container and secure to the sides of the cup. This label serves to both identify the specimen and prevent leakage. Make sure the label is marked according to the requisition form instructions. 3. Place the sealed specimen container into the zippered portion of the specimen bag and seal. Fold the completed white copy of the Laboratory Requisition and a copy of the patient’s insurance card (if applicable) along with any other supporting documentation and place in the outer pocket of the specimen bag. 4. Place an absorbent pad inside the large plastic Clinical Pack. Seperate the absorbent pad so that the specimen(s) can be placed inside of the pad. 6. Contact FedEx (1-800-463-3339) to schedule a pickup or contact Castle Medical directly at (678) 486-7340 to schedule your pickup. 5. Package sealed specimen bags inside the large plastic Clinical Pack from FedEx and seal. Seal the Clinical Pack by removing the adhesive strip and folding over. Place the Clinical Pack inside the FedEx box and place the prepaid label on the outside of the box by removing the backing portion of the label. 12 URINE TRANSPORT VIAL SAMPLE INSTRUCTIONS IMPORTANT INFORMATION NO PEE LEFT BEHIND: You must always work with one sample at a time to ensure that you do not mix one patient’s sample with another patient’s information. 1 To open collection cup, tear shrink banding along perforations, which are marked with printed arrows. 5 9 13 Carefully transfer patient’s urine using the beaker into vial. Take completed copy of requisition and add additional documents (if necessary) and insert into rear pocket. 2 Remove vials and bag from collection cup. 6 Snap vial closed completely and fold lid tab down to lock vial. Make sure you hear a “CLICK.” 10 Remove release liner from bag and seal. 3 7 Give collection cup to patient and have them fill with urine. NOTE: This cup may also be used as a beaker. Place security seal sticker from patient’s requisition form over top of vial. 4 Single Sample – Tear shrink band along perforations. 8 Insert vial(s) into front pocket of Specimen bag. ORAL FLUID (SALIVA) SAMPLE INSTRUCTIONS A. Oral Fluid Collection Procedure The QuantiSAL saliva Collection Device with Volume Adequacy Indicator is used for the oral fluid collection. Authorized personnel at the collection site should peel the pad package and remove the collector. The collector is placed under the tongue with the mouth closed. The collector device should not be moved during sampling for accurate and consistent absorption of the drugs present in saliva. When indicator window turns blue, the collector is removed. The transport tube containing 3 mL of non-azide preservative buffer is positioned upright and uncapped, and the collector is inserted into the transport tube until it snaps firmly into place for transportation. B. Fill out the requisition form appropriately and be sure to select “SALIVA” as specimen source. C. Shipping and Handling Instructions 1. Tighten the lid of the specimen tube. It will make a “click” when it is tightened. Also, make sure there is at least 5 mL of Blood in the tube for testing. For saliva samples ensure that the seal is tight and firm. 2. Place a label from the requisition form over the top of the tube, and secure it to the sides. This label serves to both identify the specimen and prevent leakage. Make sure the label is marked according to the requisition form instructions. 3. Place the sealed specimen tube into the zippered portion of the specimen bag and seal. Fold the completed white copy of the Laboratory Requisition and a copy of the patient’s insurance card, if applicable, along with any other supporting documentation, and place it in the outer pocket of the specimen bag. 4. Place an absorbent pad inside the large plastic Clinical Pack. Separate the absorbent pad so that the specimens can be placed inside of the pad. 5. Package sealed specimen bags inside the large plastic Clinical Pack from FedEx and seal. Seal the Clinical Pack by removing the adhesive strip and folding over. 6. Contact FedEx (1-800-463-3339) to schedule a pickup or contact Castle Medical directly at (678) 486-7340 to schedule your pickup. 14 SAMPLE RESULTS CASTLE MEDICAL, LLC 5700 HIGHLANDS PKWY SUITE 100, SMYRNA, GA 30082-5142 PHONE: 678-486-7340 or 855-822-7853 FAX: 678-486-7350 or 855-922-7853 EMAIL: [email protected] DIRECTOR: DR. JOHN D. ROBACK, MD., PH.D. TECHNICAL SUPERVISOR: DR. JAMES RITCHIE, PH.D. Client: CASTLE MEDICAL, LLC Client #: 1 Chart #: Doctor: Patient: TESTER, FIRST DOB: 01/01/1919 Gender: F Specimen Type: URINE Prescribed Medications: Ambien (Zolpidem) Percocet (Oxycodone) CONFIRMATION RESULTS SUMMARY Prescribed: Zolpidem Oxycodone Oxymorphone Not-Prescribed: THCA Buprenorphine Norbuprenorphine Ethyl Glucuronide Ethyl Sulfate Results in ng/ml <RL 300 126 841 >2000 630 1540 1230 Lab Acc#: 1409122000 Collected: 09/11/14 03:00 Accessioned: 09/12/14 14:36 Reported on: 05/13/15 15:50 MSK Reportable Limit (RL) in ng/ml Interpretation 20 50 50 INCONSISTENT CONSISTENT CONSISTENT 15 5 10 250 250 INCONSISTENT INCONSISTENT INCONSISTENT INCONSISTENT INCONSISTENT <RL: Less than reportable limit. The drug was either not detected or detected at levels too low to be accurately quantitated. >: The drug was detected but at very high levels. Levels are too high to quantitate. NT: Not Tested. Remarks: The presence of Norbuprenorphine is consistent with Buprenorphine medication. THCA is a metabolite of THC (Marijuana). EthylGlucuronide and EthylSulfate are metabolites of EthylAlcohol. Comments: - Pregnancy test is performed by Qualitative detection of HCG in urine SPECIMEN VALIDITY TESTING TEST RESULTS Creatine 25.0 pH 5.6 Specific Gravity 1.0042 Nitrites 2 Oxidants/Bleach 250 FLAG NORMAL NORMAL NORMAL NORMAL NORMAL The results given are for clinical diagnostic purposes only. 15 EXPECTED RESULTS >20 mg/dL 4.5 - 9.0 1.003 - 1.025 <7.5 mg/dL <500 mcg/ml IMMUNOASSAY SCREEN REPORT DRUG RESULTS Oxycodone POSITIVE Methadone NEGATIVE Amphetamines NEGATIVE Opiates NEGATIVE Cocaine Metabolite NEGATIVE Benzodiazepines NEGATIVE THC POSITIVE Barbiturates NEGATIVE Pregnancy Test NEGATIVE CASTLE MEDICAL, LLC (855)822-7853 Page 1 SAMPLE RESULTS Client: CASTLE MEDICAL, LLC Client #: 1 Chart #: Doctor: Patient: TESTER, FIRST DOB: 01/01/1919 Gender: F Specimen Type: URINE Lab Acc#: 1409122000 Collected: 09/11/14 03:00 Accessioned: 09/12/14 14:36 Reported on: 05/13/15 15:50 MSK CONFIRMATION RESULTS USING LC/MS/MS Drug Tested Results ng/ml RL AMPHETAMINES Amphetamine MDA MDMA (Ecstasy) Methamphetamine Phenobarbital <RL <RL <RL <RL 200 100 100 200 <RL <RL 200 200 BENZODIAZEPINES NEW 4-HydroxyAlprazolam 7-AminoClonazepam Chlordiazepoxide Diazepam Flunitrazepam HydroxyethylFlurazepam Lorazepam Midazolam Nordiazepam Oxazepam Temazepam Triazolam <RL <RL <RL <RL <RL <RL <RL <RL <RL <RL <RL <RL 20 20 20 20 20 20 20 20 20 20 20 20 OTHER ILLICITS Benzoylecgonine (Cocaine) PCP THCA Results ng/ml RL OPIATES/OPIOIDS BARBITURATES Butalbital Drug Tested <RL <RL 841 100 25 15 6-MAM Buprenorphine Carisoprodol Codeine DesmethylTapentadol Dextromethorphan Dextrorphan Dihydrocodeine EDDP Fentanyl Gabapentin Hydrocodone Hydromorphone Meperidine Meprobamate Methadone Morphine Naloxone Norbuprenorphine Norfentanyl Normeperidine Norpropoxyphene O-DesmethylTramadol Oxycodone Oxymorphone Pregabalin Propoxyphene Tapentadol Tramadol The results given are for clinical diagnostic purposes only. Drug Tested Results ng/ml RL ANTIDEPRESSANTS <RL >2000 4 5 <RL <RL <RL <RL <RL <RL <RL <RL <RL <RL <RL <RL <RL <RL <RL 100 50 50 50 50 50 50 100 50 50 20 <RL 4 10 <RL <RL <RL 300 126 <RL Ritalinic Acid <RL Sertraline Zopiclone/Eszopiclone 50 50 50 50 100 50 100 <RL 50 <RL 20 <RL Zolpidem 20 <RL 20 <RL 50 BATH SALTS MDPV MEPHEDRONE <RL METHYLONE <RL Alpha-PVP ALCOHOL 50 Ethyl Sulfate 50 <RL Nortriptyline 50 100 <RL Methylphenidate Zaleplon 50 <RL Imipramine 50 50 <RL Desipramine Z-DRUGS 300 <RL Cyclobenzaprine 2 <RL 630 Amitriptyline <RL Ethyl Glucuronide 1540 1230 50 50 10 250 250 50 <RL <RL <RL <RL 100 100 50 100 CASTLE MEDICAL, LLC (855)822-7853 Page 2 16 DNA REQUISITION FORM 5700 Highlands Parkway, Suite 100 Smyrna, Georgia 30082 678-486-7340 or 855-822-7853 678-486-7350 or 855-922-7853 DNA@ castlemedical.com D00001 Sex: : See Attached The information I have provided on this form is accurate. I authorize Castle Medical to release the results of this testing to the treating physician or facility. I hereby authorize my insurance or other payment benefits to be paid directly to Castle Medical for services I received. I acknowledge that Castle Medical may be an out-of-network provider with my insurer. I am also aware that in some circumstances my insurer might send the payment directly to me. I agree to endorse the insurance check and forward to Castle Medical within fifteen days of receipt. I acknowledge that I am responsible for all co-pays and deductibles not covered by insurance or other payors. WC/Auto/LOP: Insurance: Client Bill: Self Pay: Specimen Source Buccal Swab ______________ ______________ D00001 Time: ___________ Collector Initials: ___________ Date: ___________ Patient Initials: _____________ ICD - Diagnosis Codes ______________ ______________ ______________ ______________ ______________ ______________ Core DME Panel : Tested genes include CYP2D6, CYP2C9, CYP2C19, CYP3A4, and CYP3A5. These genes affect the metabolism of a wide variety of drugs, including several TCAs, benzodiazepines, opiates/opioids, muscle relaxants, and others. ChemoDME Panel : Tested genes include TPMT, DPYD, and part of the UGT family. These genes control the metabolism of several chemotherapeutic agents. Warfarin Panel : Tested genes include VKORC1, GGCX, CYP4F2, CACNA1C and CYP2C9. These genes are associated with warfarin response. MTHFR : Affects vitamin B12 and folate metabolism. Medications of Interest Acenocoumarol Alprazolam Amitriptyline Amoxapine Amphetamine Apixaban Aripiprazole Asenapine Atomoxetine Azathioprine Buprenorphine Buspirone Capecitabine Carbamazepine Carisoprodol Celecoxib Chlorpromazine Citalopram Clomipramine Clonazepam Clopidogrel Clozapine Codeine Cyclobenzaprine Cyclophosphamide Desipramine Desvenlafaxine Diazepam Diclofenac Disulfiram Doxepin Duloxetine Escitalopram Esomeprazole Fenoprofen Fentanyl Flecainide Fluoxetine Flurbiprofen Flunitrazepam Fluorouracil Fluvoxamine Guanfacine Haloperidol Hydrocodone Ibuprofen Iloperidone Imipramine Indomethacin Irinotecan Isophosphamide Ketoprofen Lansoprazole Levomilnacipran Lisdexamfetamine White - Castle Copy 17 Lorazepam Lurasidone Mefenamic Acid Meloxicam Mercaptopurine Methadone Methylphenidate Metoprolol Midazolam Mirtazapine Modafinil Yellow - Physician Copy Nabumetone Naproxen Nortriptyline Olanzapine Omeprazole Oxazepam Oxycodone Paliperidone Pantoprazole Paroxetine Phenprocoumon Pink - Patient Copy Phenytoin Piroxicam Prasugrel Propafenone Quetiapine Risperidone Rivaroxaban Sertraline Sulindac Tacrolimus Tamoxifen Tapentadol Tegafur Temazepam Ticagrelor Ticlopidine Thioguanine Tramadol Trazodone Triazolam Trimipramine Venlafaxine Vilazodone Voriconazole Vortioxetine Warfarin Ziprasidone Zolpidem Zuclopenthixol See Attached No Drugs Prescribed DNA REQUISITION FORM CHEAT SHEET 5700 Highlands Parkway, Suite 100 Smyrna, Georgia 30082 678-486-7340 or 855-822-7853 678-486-7350 or 855-922-7853 DNA@ castlemedical.com D00001 STEP 1. REQUESTING PHYSICIAN Please check the appropriate name(s) of the physician(s) requesting the test(s). STEP 2. PATIENT INFORMATION A. Last Name B. First Name D. Middle Initial : D. Social Security # E. Date of Birth F. Sex Sex: G. Address: If you leave this area blank you must check “See Attached” and provide Demographic Documentation WC/Auto/LOP: Insurance: STEP 5. INSURANCE See Attached H. Phone & Email Address Select the insurance/billing type Client Bill : patient/clinic. Self Pay: associated with the The information I have provided on this form is accurate. I authorize Castle Medical to release the results of this testing to the treating physician or facility. I hereby authorize my insurance or other payment benefits to be paid directly to Castle Medical for services I received. I acknowledge that Castle Medical may be an out-of-network provider send the payment withsure my insurer. I am also aware that and in some circumstances my insurer might Please make that the patients signs dates the requisition form and initials in thedirectly space to me. Iin agree endorse the insurance check and forward to Castle Medical within fifteen days of receipt. I provided thetopeel sticker (see next step). acknowledge that I am responsible for all co-pays and deductibles not covered by insurance or other payors. STEP 3. PATIENT SIGNATURE AND DATE STEP 4. Time: ___________ PATIENT INITIALS Collector Initials: ___________ D00001 The patient will need to write their initials on the peel sticker. Please make sure this is completed Date:information ___________ Patient Initials: _____________ when they are filling out their above. Once completed, pleast remove the peel sticker and place on top of collection tube. Specimen Source STEP 6. SPECIMEN TYPE Select “Buccal another Buccal SwabSwab” unless ______________ type of collection device has been used to collect sample. ______________ ICD - Diagnosis Codes STEP 7. DIAGNOSIS CODES ______________ ______________ In order to prove medical necessity the ______________ ______________ physician must provide a reason for why the test is being performed. ______________ ______________ STEP 8. TEST(S) REQUESTED genes include CYP2D6, CYP2C9, CYP2C19, CYP3A4, and CYP3A5. Core DME Panel : Tested These genes affect the metabolism of a wide variety of drugs, including several TCAs, benzodiazepines, opiates/opioids, muscle relaxants, and others. ChemoDME • CORE DME Panel : Tested genes include TPMT, DPYD, and part of the UGT family. These genes control the metabolism of several chemotherapeutic agents. • CHEMO DME • WARFARIN Warfarin Panel : Tested genes include VKORC1, GGCX, CYP4F2, CACNA1C and CYP2C9. These genes are associated with warfarin response. Please select the type of test requested by the physician. The options available are: • MTHFR MTHFR : Affects vitamin B12 and folate metabolism. Medications of Interest STEP 9. MEDICATIONS OF INTEREST Vilazodone Acenocoumarol Buspirone Codeine Esomeprazole Hydrocodone Lorazepam Nabumetone Phenytoin Tapentadol Alprazolam Cyclobenzaprine Fenoprofen Ibuprofen Lurasidone Naproxen Piroxicamwe have Tegafur Selecting fromCapecitabine this list is no longer a requirement. In our current reporting format, we provide all the information compiled Voriconazole about Vortioxetine Temazepam Amitriptyline Carbamazepine Cyclophosphamide Fentanyl Iloperidone Mefenamic Acid Nortriptyline Prasugrel relevant medications without Desipramine regard to marked medications. If your medication of interest is not on our report, please contact Warfarin Amoxapine Carisoprodol Imipramine Meloxicam Olanzapine Propafenone Ticagrelor Flecainide [email protected] and we'll be happy Fluoxetine to look into it.Indomethacin Ziprasidone Amphetamine Celecoxib Desvenlafaxine Mercaptopurine Omeprazole Quetiapine Ticlopidine Zolpidem Apixaban Chlorpromazine Diazepam Flurbiprofen Irinotecan Methadone Oxazepam Risperidone Thioguanine Tramadol Zuclopenthixol Aripiprazole Citalopram Diclofenac Flunitrazepam Isophosphamide Methylphenidate Oxycodone Rivaroxaban Trazodone Asenapine Clomipramine Disulfiram Fluorouracil Ketoprofen Metoprolol Paliperidone Sertraline Triazolam Atomoxetine Clonazepam Doxepin Fluvoxamine Lansoprazole Midazolam Pantoprazole Sulindac Trimipramine See Attached Azathioprine Clopidogrel Duloxetine Guanfacine Levomilnacipran Mirtazapine Tacrolimus Paroxetine Venlafaxine Buprenorphine Clozapine Escitalopram Haloperidol Lisdexamfetamine Modafinil Tamoxifen Phenprocoumon No Drugs Prescribed STEP 10. PHYSICIAN SIGNATURE Please make sure that the Physician who is requesting the test(s) signs and dates the requisition form. White - Castle Copy Yellow - Physician Copy Pink - Patient Copy 18 DNA COLLECTION PROCEDURE /2!COLLECT B OC-100 ENGLISH Procedure for oral sample collection kit: For In Vitro Diagnostic Use 1 2 10 x Collection precautions: Ensure the sponge tip does NOT come into contact with any surface prior to collection. Donor should not eat, drink, smoke or chew gum for 30 minutes before collecting oral sample. 1 Intended use: This product is designed for the collection of human oral samples. Contents: Kit contains liquid. 10 x 2 1 2 Storage: 15E30°C 10 x 2 PATIENT CAN NOT EAT, DRINK, CHEW GUM OR SMOKE 30 MINUTES PRIOR TO TEST. 3 4 5 SWAB MUST STAY ON EACH SIDE OF MOUTH FOR AT LEAST 30 SECONDS. 10 x 3 4 5 Hold the tube upright to prevent the liquid inside the tube from spilling. Unscrew the blue cap from the collection tube without touching the sponge. 10 x Summary and explanation of the kit: ORAcollect is a self-collection kit that provides the materials and instructions for collecting human oral samples. Label legend: 4 10 x Gently repeat rubbing motion on the opposite side of the mouth along the lower gums for an additional 10 times. Warning and precautions: Choking hazard. Caution should be used when inserting sponge into the mouth. Wash with water if liquid comes in contact with eyes or skin. Do not ingest. See MSDS at www.dnagenotek.com 3 Open package and remove collector without touching sponge tip. Place sponge as far back in the mouth as comfortable and rub along the lower gums (see close up image) in a back and forth motion. Gently rub the gums 10 times. If possible, avoid rubbing the teeth. 3 10 x 4 5 Turn the cap upside down, insert the sponge into the tube and close cap tightly. B Catalog number 2 In vitro diagnostic medical device " CE Marking 10 x + 10 xManufacturer . Authorized Representative E Storage instructions 10 x Industrial Design Patent & 3 Collect sample by (Use by) 4 For donor collection instructions in other languages, see http://dnagenotek.com/ DNA_Genotek_Support_Lit_UI_OC-100.html 5 Invert the capped tube and shake vigorously 10 times. 10 x Made in Canada + DNA Genotek Inc. Ottawa, ON, Canada K2K 1L1 Tel.: 613.723.5757 [email protected] www.dnagenotek.com 19 Superior samples • Proven performance U.S. Patent No. 7,482,116; European Patent No. 1 513 952 and patents pending; . Emergo Europe Molenstraat 15, 2513 BH The Hague, The Netherlands Tel: (+31) (0) 70 345-8570 Fax: (+31) (0) 70 346-7299 © 2011 DNA Genotek Inc., all rights reserved. PD-PR-172 Issue 2/2011-03 2" 1 DNA COLLECTION PROCEDURE /2!COLLECT Background B OC-100 For In Vitro Diagnostic Use OraCollect is an easy, minimally-invasive DNA collection technique that is stable for long periods at room temperature before and after collection. The collection sponge is attached to a reversible cap, minimizing the risk of contamination. To reduce the chances of sample rejection due to contamination or low DNA yield, please follow these instructions carefully, especially steps 1 and 7. Please do not refrigerate collection kits at any time, as this can decrease DNA yield. Store kits at ambient temperature and out of direct sunlight. We strongly prefer that clients send both a requisition form and a sample tube for each test ordered. For example, when requesting both the Core DME panel and MTHFR testing, please send two requisitions and two sample Collection precautions: tubes. We are often able to run multiple tests from the same sample, but this requires a good dealtipofdoes extra Ensure the sponge NOT come into processing and may cause delays in the release of results. contact with any surface prior to collection. Procedure 1 Donor should not eat, drink, smoke or chew gum for 30 minutes before collecting oral sample. 1. Ensure that the donor does not eat, drink, smoke, or chew gum for at least 30 minutes before collection. During Intended use: This product is designed for the the collection procedure, the sponge tip should never come into contact with any surface than inside of collectionother of human oralthe samples. the collection tube and the inside of the donor’s mouth. Collectors must wear a fresh pair of disposable gloves for 10 x Contents: Kit contains liquid. each collection to reduce the risk of contamination. Warning and precautions: Choking hazard. Cautioncontact should be with used when inserting sponge minimize the sample. into the mouth. 2. Observe and instruct the donor during collection to ensure compliance, but The collector may assist donors that are unable to comply with instructions. If you ever suspect that a sample has Wash with water if liquid comes in contact been contaminated or mislabeled, discard the kit and start again. 1 2 with eyes or skin. Do not ingest. See MSDS at www.dnagenotek.com 3. Open the collection kit and remove the collection unit without touching the sponge or the shaft. Be extra Storage: 15E30°C cautious to only handle the outside of the tube. 10 x 4. The goal of this collection kit is to soak up saliva, not to scrape cells off of the focus on areas where saliva pools naturally. 1 10 x Summary and explanation of the kit: cheeks or gums. Have the patient ORAcollect is a self-collection kit that provides the materials and instructions for collecting human oral samples. 2 3 5. Ask the patient if he or she is experiencing dry mouth. If the patient has trouble Label producing legend: saliva, ask him or her to think about food before collecting. If the patient’s mouth is still dry, apply a small amount of pure sugar to the B Catalog number tip of the tongue – this won’t affect the test’s results. Do not use candy, as the dyes2 can interfere with the test. In vitro diagnostic medical device " CE Marking 10along x + the 10 xlower 6. Insert the sponge into the lower cheek as shown in the collection kit and rub gums with only Manufacturer . Authorized Representative light pressure. E Storage instructions 7. Rub slowly, no fewer than 10 times, for a total of at least 30 seconds. Avoid rubbing teeth if possible. Repeat & Collect sample by (Use by) the process on the other side of the mouth with the other side of the sponge, for a total of at least one minute of For donor collection collection. Spending at least one entire minute on collection is essential for achieving usable DNAinstructions yields. in other Industrial Design Patent 1 2 3 4 languages, see http://dnagenotek.com/ DNA_Genotek_Support_Lit_UI_OC-100.html 8. Hold the tube upright and unscrew the cap from the tube, taking care not to touch the sponge tip or shaft. x and 10tighten. x Invert the cap, replace it with the sponge end inside the10 tube, 9. Hold the closed tube cap-side-down and shake vigorously 15 times, watching for leakage. This important step makes sure that cells are completely immersed in the liquid that will preserve them. 10. Affix an identifying label to the tube that contains at least the patient’s name, date ofCanada birth, and date of collecMade in + DNA Genotek Inc. tion. The specimen is now stable at ambient temperature for at least one month and can be shipped without Ottawa, ON, Canada K2K 1L1 special concern. Do not refrigerate the sample or store it in direct sunlight. Tel.: 613.723.5757 [email protected] www.dnagenotek.com side pouch. Your 11. Put the tubes in the specimen collection bag and attach the requisition in the sample is now ready for shipping or pickup. Superior samples • Proven performance 20 CASTLE MEDICAL, LLC Patient: NEWREPORT, FAKEPATIENT DOB: 01/02/1803 Gender: N/P Client: CASTLE MEDICAL, LLC Client #: 1 Doctor: ROY CLARK MD Chart #: 5700 HIGHLANDS PKWY SUITE 100 SMYRNA, GA 30082-5142 PHONE: 678-486-7340 or 855-822-7853 FAX: 678-486-7350 or 855-922-7853 EMAIL: [email protected] DIRECTOR: JOHN D. ROBACK, MD, PH.D. TECHNICAL SUPERVISOR: JAMES RITCHIE, PH.D. LISH edure for oral sample collection kit: package and remove collector without touching Summary GeneticOpen Quick Look Results 2Testing 4 sponge tip. Place sponge as far3 back in the mouth as normalthe lower gums (see close CYP2C9 comfortable and rub along CYP2C19 *1/*1 *1/*1 up image) in a back and forth motion. Gently rub the Genotype: gums *1/*310 times. If possible, avoid rubbing Genotype: the teeth. *1/*1 10 x normal 10 x Genotype: normal *1/*1 *4-like/*5 10 x Phenotype: Poor Metabolizer Enzyme Function: Enzyme Function: Enzyme Function: Moderate loss of enzyme function 3 Acenocoumarol Phenprocoumon 1 Warfarin ANTICONVULSANTS Phenytoin 1 Normal enzyme function 4 TRICYCLIC ANTIDEPRESSANTS Trimipramine 1 BENZODIAZEPINES Diazepam 1 CARDIOVASCULAR (P) Clopidogrel MUSCLE RELAXANTS (P) Carisoprodol NSAIDs Celecoxib NSAIDs Hold the tube upright to prevent the liquid inside Diclofenac 1 (P) Nabumetone 2, 3 Flurbiprofen the tube from spilling. Unscrew the blue cap from Ibuprofen OPIATES/ OPIOIDS sponge. Indomethacin the collection tube without touching the Methadone 2, 3 Ketoprofen 2, 3 Mefenamic Acid Meloxicam 1 PROTON PUMP Naproxen INHIBITORS Piroxicam (P*) Esomeprazole 1 (P*) Lansoprazole 1 (P*) Omeprazole 1 (P*) Pantoprazole 4 5 SSRIs Citalopram 1 Escitalopram 1 Sertraline 2, 3 TRIAZOLE ANTIFUNGALS Voriconazole 10 x TRICYCLIC ANTIDEPRESSANTS Amitriptyline 1 Doxepin 1 Trimipramine 1 10 x 4 Severe loss of enzyme function USE MORE FREQUENT SERUM MONITORING MAY CAUSE SERIOUS ADVERSE EFFECTS 5 Phenytoin 1 Sertraline 2, 3 BENZODIAZEPINES Diazepam 1 3 CYP2D6 Phenotype: Extensive Metabolizer of the mouth along the lower gums for an additional 10 times. ANTICOAGULANTS ANTICONVULSANTS SSRIs 0x Specimen Type: BUCCAL SWAB Phenotype: Intermediate Metabolizer USE WITH CAUTION rubbing motion on the opposite side USE AS DIRECTED MAYGently CAUSErepeat ADVERSE EFFECTS 2 5 Lab Accession: 1507021067 Accessioned: 07/02/15 17:30 Collected: 07/02/15 Reported on: 07/10/15 by: ALEX 5 Turn the cap upside down, insert the sponge into the tube and close cap tightly. ADHD THERAPY Amphetamine Atomoxetine ANTIARRHYTHMIC Flecainide Propafenone ANTIHYPERTENSION Metoprolol NSAIDs (P) Nabumetone 2, 3 OPIATES/ OPIOIDS (P) Codeine Hydrocodone Methadone 2, 3 (P) Tramadol TRICYCLIC ANTIDEPRESSANTS Amitriptyline 1 Clomipramine Desipramine Doxepin 1 Imipramine 1 Nortriptyline Trimipramine 1 TYPICAL /ATYPICAL ANTIPSYCHOTICS Aripiprazole 1 Chlorpromazine Haloperidol 1 Iloperidone 1 Olanzapine 3 Risperidone Zuclopenthixol OTHER ANTIDEPRESSANTS Amoxapine Vortioxetine SNRIs Duloxetine Venlafaxine SSRIs Escitalopram 1 Fluoxetine Fluvoxamine Paroxetine Sertraline 2, 3 10 x 5 Invert the capped tube and shake vigorously 10 times. These drugs have more than one major pathway. It is recommended to check all relevant enzymes before making dosage decisions. These drugs have more than one minor pathway. It is recommended to check all relevant enzymes before making dosage decisions. 3 The major metabolic pathways for these drugs are not tested. Phenotypic variation will have a less pronounced effect. (P )These drugs are prodrugs, meaning that they are inactive until they are metabolized. Poor or intermediate metabolizers may experience reduced therapeutic effect. (P*)These prodrugs are activated by stomach acid rather than enzymes. For the purposes of this report, they may be considered as if they were not prodrugs. For a more detailed list of drug metabolism pathways, including minor pathways and supporting references, please see www.castlemedical.com/DNA. 1 2 10 x U.S. Patent No. 7,482,116; European Patent No. 1 513 952 and patents pending; . Emergo Europe Molenstraat 15, 2513 BH The Hague, The Netherlands Tel: (+31) (0) 70 345-8570 Fax: (+31) (0) 70 346-7299 This specimen was analyzed using qPCR of DNA extracted samples for gene mutations that lead to loss or gain of enzyme function.This test was developed and its performance characteristics determined by Castle Medical LLC. It has not been cleared or approved by the FDA. The laboratory is regulated and accredited by CLIA and the College of American Pathologists (CAP) as qualified to perform high-complexity testing. This test is used for clinical DNA Genotek Inc., all research. rights reserved. purposes. It should not©be2011 regarded as investigational or for For a list of all alleles detected, see www.castlemedical.com/DNA. 21 PD-PR-172 Issue 2/2011-03 2" CASTLE MEDICAL, LLC (855)822-7853 Page 1 CASTLE MEDICAL, LLC 5700 HIGHLANDS PKWY SUITE 100 SMYRNA, GA 30082-5142 PHONE: 678-486-7340 or 855-822-7853 FAX: 678-486-7350 or 855-922-7853 EMAIL: [email protected] DIRECTOR: JOHN D. ROBACK, MD, PH.D. TECHNICAL SUPERVISOR: JAMES RITCHIE, PH.D. Patient: NEWREPORT, FAKEPATIENT DOB: 01/02/1803 Gender: N/P Client: CASTLE MEDICAL, LLC Client #: 1 Doctor: ROY CLARK MD Chart #: Lab Accession: 1507021067 Accessioned: 07/02/15 17:30 Collected: 07/02/15 Reported on: 07/10/15 by: ALEX Specimen Type: BUCCAL SWAB Supplementary Information - Known Inducers and Inhibitors CYP2C9 INHIBITORS Amiodarone Capecitabine Cotrimoxazole Diltiazem Etravirine Fluconazole Fluoxetine Fluvastatin Fluvoxamine Ketoconazole Metronidazole Miconazole Oxandrolone Rosuvastatin Sertraline Sulfinpyrazone Tigecycline Verapamil Voriconazole Zafirlukast CYP2C19 INDUCERS Aprepitant Bosentan Carbamazepine Hyperforin - (St. Johnʼs Wort) Phenobarbital Rifampin INHIBITORS Allicin (garlic derivative) Armodafinil Carbamazepine Cimetidine Cyclosporine Esomeprazole Etravirine Felbamate Fluconazole Fluoxetine Fluvoxamine Human growth hormone (rhGH) Ketoconazole Miconazole Moclobemide Nicardipine Omeprazole Oral contraceptives Ticlopidine Voriconazole CYP2D6 INDUCERS Acetylsalicylic acid (low-dose aspirin) Artemisinin Dexamethasone Rifampin INHIBITORS Amiodarone Bupropion Celecoxib Cimetidine Cinacalcet Cyclosporine Diltiazem Diphenhydramine Duloxetine Febuxostat Fluoxetine Gefitinib Hydralazine Hydroxychloroquine Imatinib Methadone Moclobemide Nicardipine Norfloxacin Paroxetine Phenelzine Quinidine Ranitidine Ritonavir Saquinavir Sertraline Terbinafine Ticlopidine Verapamil INDUCERS No verified inducers known The use of medications and other chemicals that induce and inhibit enzymes can lead to a temporary change in metabolizer phenotype. The use of inhibitors will reduce a patientʼs metabolic activity in that enzyme, while the use of inducers will increase it. Inducers and inhibitors can change the dosage of medications required in achieve therapeutic effect. Please refer to www.castlemedical.com/DNA for more complete list and reference citations. This list, which will appear in every report, will help warn physicians about potential drug interactions. Please feel free to contact the DNA department at [email protected] or (678) 486-7340 x. 641. This specimen was analyzed using qPCR of DNA extracted samples for gene mutations that lead to loss or gain of enzyme function.This test was developed and its performance characteristics determined by Castle Medical LLC. It has not been cleared or approved by the FDA. The laboratory is regulated and accredited by CLIA and the College of American Pathologists (CAP) as qualified to perform high-complexity testing. This test is used for clinical purposes. It should not be regarded as investigational or for research. For a list of all alleles detected, see www.castlemedical.com/DNA. CASTLE MEDICAL, LLC (855)822-7853 22 ONLINE SUPPLY ORDERING 1. Visit www.castlemedical.com/order 2. Select the Supply Order Form by clicking in the center of the box or the hyperlink text below the image. 3. A new pop-up window will open. Follow the easy-to-use order form and select the appropriate supplies as needed, including: • • • • • 23 DNA Kits P.O.C. (Point-Of-Care) Cups Clinical Packs Swabs Specimen Bags ONLINE RESULT INQUIRY 1. Visit www.castlemedical.com and click the Login button at the top right corner of your screen. 2. Enter your unique login credentials to access your reports. 3. At the next screen click on Result Inquiry. 4. You can search results by: a. First & Last Name b. Order Date or Collection Date c. Both Name & Date for More Specific Results 5. Once you have entered the pertinent information click Start Search to begin the search process. 6. You will now be able to see: a. Patient Name b. Test Date c. Sample Collection Date for the Patient d. The Accession # e. Date of Birth f. Client that Ordered the Result 7. To view the results of a specific patient click on their name (either first or last). Note: If a report is Pending please be advised that a certifying scientist is working on results and it will be considered “incomplete”until further notice. 24 ONLINE WEB ORDERING 1. Visit www.castlemedical.com and click the Login button at the top right corner of your screen. 2. If you have not received login credentials for your client(s) patient results, please contact Customer Service as they can provide you with a unique login. 3. Select New Test Order from the navigation pane on the left hand side of your screen. This will bring up a new tab called Orders. 4. If a patient has received Castle Medical services in the past, you can search by Patient’s first and last name and then click search. If you cannot locate a patient using this method please continue to Step 5. 5 Select Click Here To Add A New Patient. 5 25 ONLINE WEB ORDERING 5. This will take you to the Patient Information tab. Please be sure to fill out all required fields in green. 6. Once finished entering the patient information, click Save & Continue at the bottom of the page. 7 You will now be directed to the Insurance Info Tab. Here you can click the Same as patient option if you would like to populate the patient’s info from the previous page. 7a To lookup patient’s insurance provider click “Lookup Insurance Code”and type insurance name. Select insurer with same address listed on the back of the card. 7b If Castle Medical is billing the client for services, please select Bill Client. A client-bill agreement must be on file to select this option. 7c 7 7a 7b 7c 8 If the patient is a self-pay patient please select Bill Patient. If you select this option you can continue to Step 9. 8 Please note that there are two sections; primary insurance and secondary insurance. If a patient only provides a primary insurance card, you will only need to fill out the primary section. If two cards are provided, please be sure to fill out primary insurance information on the left and secondary info on the right. 9. Click Save/Continue once completed. 26 ONLINE WEB ORDERING 9. On the Specimen Info tab, please be sure to fill-in all required items marked in green. For Source, the options are as follows: Urine, Blood or Saliva. Please be sure to click Save/Continue. 10. On the Test Info tab, you will be required to enter the type of test you would like Castle to run. You will have the option to add a Test By Code, search by Test Name or input Special Test Instructions. 11. Once you have added all tests to the list click, Save & Continue. Note: If a Test Order Questionairre appears, please select Cancel to proceed to the next page. 12. Next, you will need to enter Diagnosis Info. You can enter as many diagnosis codes as are considered medically necessary. 27 ONLINE WEB ORDERING 13. If you need to lookup the diagnosis code for the patient click the Search By Description button and enter the patient diagnosis, select the correct diagnosis from the list. 14. Click the Finish Button. 15. The Prescribed Medication page will pop-up. Be sure to select all prescriptions that the patient is currently prescribed. 15a 15a If prescribed medication is unknown or no medication is prescribed, please select appropriate boxes. 16. After clicking Save from this screen an electronic requisition and four (4) labels will automatically print. 17. Be sure to take the labels and: a . Place one (1) on top of the lid. b. Place one (1) on the side of the cup. c . Place the remaining (2) on any additional documentation. 18. Please be sure that both Patient and Physician sign the printed electronic requisition before sending. 19. Once all orders have been entered, click the “order log” button under the menu. Select the date of the log that corresponds with the samples that are being sent and click “Start Search.” Click the print button at the bottom of the page. sample electronic requisition 28 the importance of MEDICAL NECESSITY Medical necessity is defined as accepted health care services and supplies provided by health care entities, appropriate to the evaluation and treatment of a disease, condition, illness or injury and consistent with the applicable standard of care. COMMON DIAGNOSES THAT PROVE MEDICAL NECESSITY Reporting poor pain control despite high doses of med. Family history of substance abuse Patient has history of abuse Taking prescription narcotics from multipe providers Patient has drug dependence issues Report of selling prescription drugs Unapproved use of drug to treat non-pain symptoms Suspicion of continued substance abuse Patient has an unreliable history Obtaining drugs from a non-medical source Borrowing medications from someone else Suspected drug abuse Patients that may present high risk or synergentic interactions with prescribed medications History of moderate to high alcohol use Drug hoarding (taking less than prescribed) Preliminary screen inconsistent with self-report Treatment for chronic opioid therapy Frequent prescription losses Unspecified drug dependence questions to ask yourself... 1. Is your medical record proving proper medical necessity? If you don’t know the what, and you don’t know the why, then your medical record just won’t fly. 2. Are you documenting why the test(s) are being ordered for your patient(s)? PLE SAM 3. Are you documenting what tests are being ordered? urinetheknow 29 W the If you don’t know the what, and you don’t know the why, then your medical record just won’t fly. test CAN YOU ANSWER THE FOLLOWING QUESTIONS? WHY ARE YOU TESTING? Patient has an unreliable history WHAT ARE YOU TESTING? SCREENING? Suspected drug abuse CONFIRMATION? Patient has history of abuse Suspicion of continued substance abuse Present high risk or synergistic interactions with prescribed medications Treatment for chronic opioid therapy BOTH? the Wtest TESTING FOR: MDMA • PCP • TCAs THC • Alcohol Amphetamines Barbiturates Buprenorphine Benzodiazepines Cocaine • Opiates Methamphetamines Methadone Oxycodone WHEN ARE YOU TESTING? The patient’s diagnosis will determine how often they should be treated. 30 urinegoodcompany