Clinical Genomics Test Requisition Form - Page 1 of 5 (Exome Sequencing and Microarray)

Transcription

1 Cliical Geomics Test Requisitio Form - Page 1 of 5 (Exome Sequecig ad Microarray) COMPLETE ENTIRE FORM TO AVOID DELAYS patiet iformatio Date of Birth (MM/DD/YY) Date of Death (If applicable) Phoe Number/ Aliso Viejo, CA USA Toll Free: Fax: ambryge.com Address City State Zip Biological Sex F M Ethicity: Africa America Asia Caucasia Hispaic Jewish (Ashkeazi) Portuguese Other: specime iformatio*(for phlebotomy service, select all services you are requestig) Type(s) Blood (EDTA preferred) Saliva (Oly available for orders ot icludig mtdna) DNA, Source: Cultured CVS Cultured amiocytes Other: Persoal history of allogeic boe marrow or peripheral stem cell trasplat Curret diagosis of heme maligacy, Type: Collectio Date Specime ID Medical Record # *Blood or saliva from patiets with active/recet hematological disease will udergo additioal review ad may ot be accepted i some cases. For these, cultured fibroblasts or fresh/fresh froze ormal tissue are preferred. See ambryge.com/specime-requiremets for details. Phlebotomy Services Request: Phlebotomy draw Isurace preverificatio first Sed kit to patiet^ ^As the patiet's cliicia, I am uaware of ay potetial for complicatio or difficulty i drawig blood for the listed patiet(s). I uderstad that the phlebotomist has full authority to refuse to draw ay patiet if the safety of the phlebotomist ad/or patiet(s) are i questio. orderig physicia/sedig facility (Each listed perso will receive a copy of the report) Facility Name (Facility Code) Address City State /Coutry Zip Phoe Orderig Licesed Provider Name (Last, First)(Code) NPI# Phoe Fax/ additioal results recipiets Geetic Couselor or Other Medical Provider Name (Last, First) (Code) Phoe/Fax/ cofirmatio of iformed coset ad medical ecessity for geetic testig The udersiged perso (or represetative thereof) esures he/she is a licesed medical professioal authorized to order geetic testig ad cofirms that the patiet has give appropriate coset. I cofirm that testig is medically ecessary ad that test results may impact medical maagemet for the patiet. I agree to allow Ambry Geetics to facilitate the provisio of pre-test geetic couselig services by a third party service, Iformed DNA (uless otherwise oted), as required by the patiet s isurace provider (uless this box is checked ). Furthermore, all iformatio o this TRF is true to the best of my kowledge. My sigature applies to the attached letter of medical ecessity. Sigature Required for Processig Medical Professioal Sigature: Date: isurace billig (Iclude copy of both sides of isurace card) Patiet Relatio to Policy Holder? Self Spouse Child Isurace Compay Name ad DOB of Policy Holder (if ot self) Policy # HMO Auth # Out Of Pocket: Ambry Geetics will start testig immediately. We will attempt to cotact the patiet if: Out-of-pocket amout is greater tha $100 (default) There is ay out-of-pocket amout Do ot iitiate testig util patiet is cotacted ad approves paymet terms regardig out-of-pocket Patiet agrees to cotact regardig out-of-pocket amout by: Phoe (icludes texts) - cofirm mobile # istitutioal billig Facility Name Sed ivoice to facility address above Address Cotact Name Phoe Number patiet paymet /Fax Check (Payable to Ambry Geetics) Credit Card (Call ) Patiet Ackowledgemet: I ackowledge that the iformatio provided by me is true ad correct. For direct isurace billig: I authorize my isurace beefits to be paid directly to Ambry Geetics Corporatio (Ambry), authorize Ambry to release medical iformatio cocerig my testig to my isurer, to be my desigated represetative for purposes of appealig ay deial of beefits as eeded ad to request additioal medical records for this purpose. I uderstad that I am fiacially resposible for ay amouts ot covered by my isurer ad resposible for sedig Ambry moey received from my health isurace compay. For patiet paymet by credit card: I hereby authorize Ambry Geetics Corporatio to bill my credit card as idicated above. I order to expedite cosideratio for eligibility for Ambry s E.P.I.C. Program, please provide the total aual gross household icome: $ ad the umber of family members i the household supported by the listed icome:. I authorize Ambry Geetics Corporatio to verify the above iformatio for the sole purpose of assessig fiacial eed, icludig the right to seek supportig documetatio. for y residets: I am a New York residet ad I give Ambry Geetics permissio to store my sample for loger tha 60 days. NOTE: If left blak, coset is iterpreted as NO. Sigature Required For Isurace/Self-Pay Patiets ad NY Sample Storage Coset: Date:

2 Cliical Geomics Test Requisitio Form - Page 2 of 5 ONLY COMPLETE FOR EXOMENEXT-TRIO ORDERS IF FAMILY MEMBERS WILL BE SUBMITTED. All family member specimes must be received withi 4 weeks of order. Otherwise test will be ru as Probad oly. trio member #1 iformatio Date of Birth (MM/DD/YY) Date of Death (If applicable) Phoe Number/ Biological Sex: F M Ethicity: Africa America Asia Caucasia Hispaic Jewish (Ashkeazi) Portuguese Other: Address: Same as Probad Address City State Zip Relatioship to probad specime iformatio*(for phlebotomy service, select all services you are requestig) Type(s) Blood (EDTA preferred) Saliva DNA, Source: Other: Persoal history of allogeic boe marrow or peripheral stem cell trasplat Curret diagosis of heme maligacy, Type: Collectio Date Specime ID Medical Record # *Blood or saliva from patiets with active/recet hematological disease will udergo additioal review ad may ot be accepted i some cases. For these, cultured fibroblasts or fresh/fresh froze ormal tissue are preferred. See ambryge.com/specime-requiremets for details. Phlebotomy Services Request: Phlebotomy draw Isurace preverificatio first Sed kit to patiet^ ^As the patiet's cliicia, I am uaware of ay potetial for complicatio or difficulty i drawig blood for the listed patiet(s). I uderstad that the phlebotomist has full authority to refuse to draw ay patiet if the safety of the phlebotomist ad/or patiet(s) are i questio. cliical iformatio Is Family Member affected with the same pheotype as the probad? Yes No Partially Possibly Describe: secodary fidigs Secodary fidigs results are available for each family member sequeced as part of the trio. Check below to opt-out of the ACMG Recommeded List of secodary fidigs. If left uchecked, secodary fidigs will be reported. (For expaded secodary fidigs optios ad pricig please complete the ExomeNext Expaded Secodary Fidigs Request Form ). Opt-out: I choose to declie the ACMG Recommeded List of secodary fidigs. trio member #2 iformatio Date of Birth (MM/DD/YY) Date of Death (If applicable) Phoe Number/ Biological Sex: F M Ethicity: Africa America Asia Caucasia Hispaic Jewish (Ashkeazi) Portuguese Other: Address: Same as Probad Address City State Zip Relatioship to probad specime iformatio*(for phlebotomy service, select all services you are requestig) Type(s) Blood (EDTA preferred) Saliva DNA, Source: Other: Persoal history of allogeic boe marrow or peripheral stem cell trasplat Curret diagosis of heme maligacy, Type: Collectio Date Specime ID Medical Record # *Blood or saliva from patiets with active/recet hematological disease will udergo additioal review ad may ot be accepted i some cases. For these, cultured fibroblasts or fresh/fresh froze ormal tissue are preferred. See ambryge.com/specime-requiremets for details. Phlebotomy Services Request: Phlebotomy draw Isurace preverificatio first Sed kit to patiet^ ^As the patiet's cliicia, I am uaware of ay potetial for complicatio or difficulty i drawig blood for the listed patiet(s). I uderstad that the phlebotomist has full authority to refuse to draw ay patiet if the safety of the phlebotomist ad/or patiet(s) are i questio. cliical iformatio Is Family Member affected with the same pheotype as the probad? Yes No Partially Possibly Describe: secodary fidigs Secodary fidigs results are available for each family member sequeced as part of the trio. Check below to opt-out of the ACMG Recommeded List of secodary fidigs. If left uchecked, secodary fidigs will be reported. (For expaded secodary fidigs optios ad pricig please complete the ExomeNext Expaded Secodary Fidigs Request Form ). Opt-out: I choose to declie the ACMG Recommeded List of secodary fidigs. Note: Additioal relatives may be submitted for co-segregatio aalysis, free of charge. Please complete "Cliical Geomics Family Member TRF" if additioal relatives will be icluded.

3 Cliical Geomics Test Requisitio Form - Page 3 of 5 idicatios for testig ICD-10 code(s): probad's primary idicatio for testig please also provide cliic otes ad pedigree probad s cliical overview (Check all that apply) Audiologic/Otolarygologic Cardiovascular Craiofacial Detal Dysmorphic Features Dermatologic Edocrie Fetal (Please complete ad attach " Exome Preatal Questioaire") Gastroitestial Geitouriary Growth Disorders: Udergrowth Overgrowth Failure to thrive Hematologic Immuologic/Ifectious/Allergy Metabolic/Biochemical Movemet Disorder Musculoskeletal/Structural Multiple Cogeital Aomalies Neurologic Seizures/Epilepsy Autism Spectrum Disorder Developmetal Delay/Itellectual disability Ataxia/Spasticity Psychiatric Abormal brai MRI Obstetric Ocologic Ophthalmologic Pulmoary Real Toe abormalities Hypotoia Hypertoia additioal cliical details Autism: o autistic behaviors autistic behaviors (describe): Dysmorphic Features (describe): Cogeital Aomalies (describe): History of Seizures Yes No diagosed epilepsy Seizure type(s): Progressive disease Yes No Previous Studies MRI/CT studies (fidigs): Chromosome aalysis: Microarray aalysis: Other molecular studies: Growth Idices (curret): Head circumferece: % Weight: % Height: % Differetial diagosis/gees of iterest: family history (Please attach pedigree) Is ayoe i the family affected with a similar pheotype as the probad? NO YES, please list exact relatioship to probad, symptoms ad age of oset of symptoms: Is there ay cosaguiity (coceptio betwee blood relatives) i the family? NO YES If yes please describe:

4 Cliical Geomics Test Requisitio Form - Page 4 of 5 Please check the box ext to the test(s) beig ordered below. If this TRF is set to Ambry without or ahead of the sample, it will be treated as a preverificatio. If test ordered is differet tha the test preverified, we will hoor what is o the TRF order form with the sample. For multiple test orders, testig will be ru cocurretly (multiple tests iitiated at the same time) uless otherwise specified. To order reflexive testig (secod test starts pedig first test outcome), please clearly idicate the order of reflexive tests i the otes sectio or ext to the test check box. For reflex test orders, ay positive fidigs (pathogeic/likely pathogeic) i the first test will be reported out to the cliicia, ad the requested secod test will be caceled; all other fidigs will automatically reflex (icludig VUS). Check to order Karyotype Test Name Test Code Karyotype 3660 Karyotype, rule out mosaic Chromosomal Microarray Aalysis 3662 SNP Array 5490 Paretal targeted microarray Exome Sequecig 5495 ExomeNext-Probad 9993 ExomeNext-Probad plus mtdna^ 9994 ExomeNext-Trio 9995 ExomeNext-Trio plus mtdna^ 9996 ExomeNext-Rapid* 9999R Order through AP** ExomeNext-Select 9500 Descriptio Chromosome aalysis (requires greetop sodium-hepari tube) Chromosome aalysis (requires greetop sodium-hepari tube) Chromosomal microarray (>2.6 millio copy umber probes ad 750,000 SNP probes) Paid optio. Oly available followig SNP Array (5490) completed at Ambry. Icidetal fidigs urelated to the variat(s) detected i the probad, will NOT be reported. Name of probad tested at Ambry: Probad oly exome sequecig Probad oly exome sequecig plus mtdna sequecig Trio exome sequecig Cadidate (Novel) Geetic Etiologies: Opt-out Trio exome sequecig plus mtdna sequecig Cadidate (Novel) Geetic Etiologies: Opt-out Rapid Trio exome sequecig plus mtdna sequecig Cadidate (Novel) Geetic Etiologies: Opt-out Up to 500 gee custom exome sequecig test ^Mitochodrial (mtdna) testig caot be performed o saliva samples. ^^Secodary Fidigs: If box is left uchecked, the ACMG recommeded list of Secodary Fidigs will be reported. Secodary Fidigs are ot available for ExomeNext-Select orders. *Istitutioal billig or patiet paymet oly **AP is AmbryPort, our olie portal ambryge.com/ap sigle site aalysis (Please iclude a copy of relative's report) Gee(s): Mutatio(s): Relative Name: Relatioship to Relative: Accessio # (If tested at Ambry): Positive cotrol sample: will be provided already at Ambry ot available for preatal specimes oly: materal cell cotamiatio (Both test codes required for fetal specimes) 1260 MCC for amiotic fluid culture or CVS (ru cocurretly with test) 1262 MCC Referece for materal blood sample (No Charge) other order Please visit ambryge.com/tests for details. Test Code: Test Name: Notes: orderig checklist (Required*) Probad specime Cliical Geomics TRF with patiet & cliicia sigatures Cliical history (attach cliic otes) Medical Necessity Form (isurace orders oly) (see page 5) Copy of Isurace Card (isurace orders oly) *Orders with missig requiremets will be placed o hold util all requiremets are received. orderig checklist (Highly Recommeded) Family member specimes** Family history or pedigree Previous test results **Please sed all first degree ad other iformative relatives withi 4 weeks of the order. cotact iformatio For ExomeNext preverificatio requests please sed the Medical Necessity Form ad Cliical Geomics TRF to preverificatio@ambryge.com or fax to All other documets ca be secure uploaded at ambryge.com/secure-upload, or faxed to AmbryPort is a ew secure cliet portal that allows order submissio, test status updates, isurace authorizatio status ad report dowloads. All required documets ca be completed ad directly uploaded through AmbryPort durig the orderig process or after order submissio. Please visit portal.ambryge.com/sigup to sig up.

5 ExomeNext Medical Necessity Form - Page 5 of 5 REQUIRED FOR INSURANCE ORDERS ONLY This form is required if you are orderig Exome testig ad wish to have the patiet s isurace billed. Please complete ad submit with the TRF ad a copy of cliical otes. This form replaces the Letter of Medical Necessity. 1. Has the patiet had previous Whole Exome Sequecig (WES) performed? Yes, date performed: No 2. Does this patiet have a cliical presetatio cosistet with the followig (select all that apply): Multiple abormalities affectig urelated orga systems (please specify): OR two of the followig: Abormality affectig a sigle orga system(specify): Sigificat itellectual disability, symptoms of a complex eurodevelopmetal disorder (i.e. self-ijurious behavior, reverse sleep-wake cycle, or seizure/epilepsy), or severe europsychiatric coditio (e.g. schizophreia, bipolar, Tourette sydrome) Family history strogly implicatig a geetic etiology (please specify fidigs ad relatioships) Period of uexplaied developmetal regressio (urelated to autism or epilepsy) 3. Are the results of this WES test expected to directly ifluece this patiet s medical maagemet recommedatios ad cliical outcome? Yes (please describe): No 4. Please describe the geetic tests that would be idicated if WES were NOT performed (i.e., sigle gee tests, gee paels, etc.): Chromosomal microarray Sigle gee test(s): Multigee pael(s): Other geetic test(s): 5. Please describe follow-up procedures & frequecy that would be eeded if WES were NOT performed (i.e., lumbar pucture, imagig studies, brai MRI, etc.): Imagig study: Surgery: Biopsy: Other: _v