Directory of Laboratory Services

Transcription

1 Directry f Labratry Services Interpace Diagnstics Crpratin TEL: CO-SOP-1007

2 Directry f Labratry Services Table f Cntents List f Testing Services... 3 Acceptable specimen criteria... 3 Rejectin criteria... 3 Specimen Cllectin Requirements... 4 Specimen Labeling Requirement... 4 Vlume/Specimen Requirements... 5 Cntrl Prep... 5 Thyrid Testing... 6 Cytlgy Testing... 6 Pancreas Testing... 6 Histlgy Testing... 8 CEA/Amylase Testing... 8 Ordering Tests... 9 Specimen Packaging... 9 Shipping Specimens t Interpace Diagnstics Billing Infrmatin Specimen Viability Service (SVS) Imprtant Cntact Infrmatin Interpace Diagnstics 2515 Liberty Avenue Pittsburgh, PA Interpace Diagnstics CO-SOP-1007 Page 2 f 13

3 List f Testing Services Directry f Labratry Services Interpace Diagnstics ffers multiple tests available in all states unless therwise mentined. ThyGenX /ThyraMIR Fr Thyrid cytlgy slides available in all states except NY. Cytlgy: Fr Thyrid ndule FNA available in all states except RI. Fr Pancreatic Cyst FNA available in all states except NY, FL, and RI. PancraGen Mlecular Analysis GNAS Mutatin BarreGen Mlecular Analysis Interpace Mlecular Analysis AccuCEA and Amylase Chemistry testing Acceptable specimen criteria fr testing: ThyGenX /ThyraMIR Dedicated FNA bipsy f the thyrid in RNARetain nly Cytlgy slides with Papaniclau r Diff-Quik stain Cytlgy testing All bdy fluids, masses and ERCP brushes PancraGen Mlecular Analysis Pancreaticbiliary fluid Pancreaticbiliary cytlgy brushings Cntrl: Buccal Brush r Whle Bld in EDTA/ACD GNAS Perfrmed upn request n pancreatic cyst fluid samples nly BarreGen Mlecular Analysis Histlgy slides with frmalin and ther rutine fixatives Paraffin embedded tissue and cell blcks 10% buffered frmalin, B6, parafrmaldehyde and mst cmmn fixatives accepted Interpace Mlecular Analysis Cyt-centrifugatin supernatants (pancreatic mass r pancreaticbiliary ductal brushing) Cytlgy slides with Papaniclau r Diff-Quik stain Paraffin embedded tissue and cell blcks 10% buffered frmalin, B6, parafrmaldehyde and mst cmmn fixatives accepted Other specimen types - cntact Interpace Diagnstics Client Services department if yu have a questin regarding submissin f ther specimen types AccuCEA and Amylase Chemistry testing All bdy fluids Specimen Viability Service (SVS) Specimen strage service prvided by Interpace Diagnstics at n cst fr clients t maintain specimens fr pssible future testing. Rejectin criteria: All Tests Frzen specimens C-mingled specimens Unlabeled r mislabeled specimens Missing, incmplete, incrrect r illegible test requisitins Leaking r brken specimen vial Imprper specimen type Cltted bld (fr cntrls) in red tp tube 2017 Interpace Diagnstics CO-SOP-1007 Page 3 f 13

4 Rejectin criteria test specific: Directry f Labratry Services ThyGenX /ThyraMIR Thyrid specimens in media ther than RNARetain are nt acceptable FFPE thyrid specimens FNA specimens >6 weeks frm date f cllectin Cytlgy testing Specimens >14 days frm date f cllectin PancraGen Mlecular Analysis Fluids diluted in any slutin. Bleached, decalcified r tissue fixed histlgy slides in Zenker s and Buin s fixative Specimens will be discarded after 45 days frm date f cllectin BarreGen Mlecular Analysis Bleached, decalcified r tissue fixed histlgy slides in Zenker s and Buin s fixative Interpace Mlecular Analysis Cytlgy brushings may be placed in apprved preservative r media. CytLyt and ther rutine cytlgy media are acceptable, as per Test Requisitin Frm. CytRich Red and acetic acid are nt acceptable. Bleached, decalcified r tissue fixed histlgy slides in Zenker s and Buin s fixative AccuCEA and Amylase Chemistry testing Specimens >28 days frm date f cllectin Specimen Cllectin Requirements Patient Preparatin: N special preparatin r timing is required fr cllectin f specimens. Cntrl Preparatin: Fr pancreas specimens, buccal brushes are required and used t cllect nrmal cntrl samples. Fr instructins, please refer t the Cntrl Prep sectin. If there are any questins regarding specimen cllectin, handling, r shipping, cntact Interpace Diagnstics Client Services at Specimen Labeling Requirement Cmplete and crrect labeling f specimens ensures prper identificatin and integrity f patient samples and accurate test reprting. All specimen cntainers must be labeled with at least tw patient identifiers. One must be the patient s full name as it appears n the test requisitin, and the ther identifier may be the date f birth and gender, scial security number, medical recrd number, r specimen accessin number (Pathlgy Department). Micrscpe slides must be labeled with the submitting Pathlgy Department s accessin number. A cpy f the pathlgy r cytlgy reprt must be prvided fr crss-checking the Test Requisitin Frm with patient name, date f cllectin and with the Pathlgy Department s accessin number Interpace Diagnstics CO-SOP-1007 Page 4 f 13

5 Vlume/Specimen Requirements Directry f Labratry Services VOLUME/SPECIMEN REQUIREMENTS FOR ALL SPECIMEN TYPES TEST REQUESTED SAMPLE VOLUME/REQUIREMENT ThyGenX /ThyraMIR 1 dedicated FNA pass in RNARetain r cytlgy slides Thyrid Cytlgy*** 1 IDX Specimen Cllectin Kit AccuCEA, Amylase*, PancraGen, Cytlgy** 800 µl (0.8 ml) AccuCEA, Amylase*, PancraGen 600 µl (0.6 ml) AccuCEA, Amylase*, Cytlgy ** 600 µl (0.6 ml) AccuCEA * Only 200 µl (0.2 ml) Amylase* Only 200 µl (0.2 ml) Cytlgy** 200 µl (0.2 ml) PancraGen Only 200 µl (0.2 ml) BarreGen 1 FFPE blck r 1 H&E and 8 unstained recuts Metastases vs. Primary Tumrs (MvP) 1 FFPE blck r 1 H&E and 8 unstained recuts Tissue Identity (TI) 1 FFPE blck r 1 H&E and 8 unstained recuts *Specimens submitted that d nt meet vlume requirements will be tested using a dilutin prtcl r the rdering physician may be cntacted fr testing pririty. ** Cytlgy testing is nt available n pancreatic specimens submitted frm NY, FL r RI. *** Cytlgy testing is nt available n thyrid specimens submitted frm RI. All ther testing is accepted fr all states unless therwise stated abve. Cntrl Prep A cntrl sample is nt required fr ThyGenX /ThyraMIR testing. One cntrl sample is required with the submissin f a sample fr PancraGen, Cytlgy, Cyt-centrifugatin Supernatant Pancreaticbiliary specimens, and Metastases vs. Primary Tumrs (MvP). It is recmmended fr all BarreGen and Tissue Identity (TI) specimens. The fllwing are acceptable cntrls: Buccal Brush Scraping A buccal brush scraping is used as a cntrl (nrmal cellular material) fr all specimens. These brushes are supplied in the Interpace Specimen Cllectin Kit in a frsted plastic cntainer, which is t be reused fr shipment back t Interpace Diagnstics. Preparatin f the patient is required fr cllectin f this sample: Scrape superficial layer f buccal mucsa fr 10 secnds using the sterile cytlgy brush prvided in the Interpace Specimen Cllectin Kit. D nt rinse r add preservatives. Place the entire brush back int the cntainer and clse. Prperly label the cntainer and place in the bihazard bag with the sample t be tested. Ship vernight. Bld Bld may be used as the nrmal cntrl material if a buccal brush scraping is nt available. Apprximately 1.0mL f anti-cagulated peripheral bld is sufficient fr analysis. Use ne lavender tp (EDTA as anticagulant) bld cllectin tube r ne yellw tp (ACD slutin A r B) bld cllectin tube. Mix bld well in tube. D nt use tubes with any ther types f additives r anti-cagulants. Label tube apprpriately with patient identifiers and the date and time f cllectin. Ship vernight 2017 Interpace Diagnstics CO-SOP-1007 Page 5 f 13

6 Directry f Labratry Services Histlgy Slides Include ne sectin with nn-neplastic tissue (per shipping instructins) if available. Thyrid Testing Specimen Prep fr ThyGenX /ThyraMIR Cllect a dedicated FNA bipsy and express it int the prvided preservative slutin cntained in the Interpace Specimen Cllectin Vials bx. Invert vial 2-3 times. FNAs frm the same ndule can be expressed int the same vial f preservative slutin. FNAs frm different ndules needs t be expressed int separate vials, and the lcatin f each ndule shuld be nted n the requisitin frm AND labeled n the vial crrespndingly. If sending cytlgy slides please marked with areas f interest Specimen Strage and Packaging Specimens may be stred at ambient temperature up t six (6) weeks in RNARetain (prvided preservative) slutin until shipped Use the Interpace Specimen Transprt Kit t ship the specimens Cytlgy Testing Endcrine: Thyrid FNA smears and CytLyt are accepted fr cytlgy testing. Specimens shuld be cllected with the Interpace Cytpathlgy + Mlecular Kit. Specimens shuld be sent t us immediately after cllectin. Cytlgy testing is perfrmed by ne f ur renwned affiliates. GI: All bdy fluids, masses and ERCP brushes are accepted fr cytlgy testing. Specimens shuld be sent in the Interpace Specimen Cllectin Kit r PreservCyt Cllectin Kit and shipped with 2 frzen bricks. Specimens shuld be sent t us immediately after cllectin. As with every lab, cytlgy analysis is affected by the nature f the fluid specimens. Many pancreaticbiliary fluid specimens are acellular r nly cntain cellular debris. The lnger a specimen is stred, the higher the risk f cellular degradatin. Cytlgy testing is nt available fr specimens submitted frm New Yrk, Flrida and Rhde Island. Preparatin f fluid cytlgy specimens is perfrmed at Allegheny General Hspital, Pittsburgh, PA. Pancreas Testing Specimen Prep fr Pancreatic Cyst Fluid Specimens (PancraGen ) Cllect fr pancreatic cyst fluid specimens nly. Place pancreatic cyst fluid specimen in prvided plyprpylene 2 ml tubes cntained in the Interpace Specimen Cllectin Kit prvided by Interpace Diagnstics. Imprtant Nte: Preservatives and buffers shuld nt be added t these fluid aspirates. If multiple fluid specimens are cllected frm different lesins/cysts fr the same patient: Place specimens in separate tubes and label prperly (each tube with 2017 Interpace Diagnstics CO-SOP-1007 Page 6 f 13

7 Directry f Labratry Services crrespnding specimen lcatin r pass) s that there is clear distinctin between the specimen tubes. Aspirated fluid cllected at different times shuld nt be placed int the same tube as well. Indicate the number f specimen vials and whether vials are frm the same r multiple cyst/s in the specimen infrmatin sectin n the Test Requisitin Frm. Testing requires submissin f a nrmal cntrl. Specimen Strage If there will be a delay in shipping, hld specimens refrigerated at 2-8 C until specimen can be shipped vernight. D nt freeze the aspirate. Specimen Prep fr Cyt-centrifugatin Supernatant Pancreaticbiliary Specimens Cllect fr cytlgy, pancreatic mass, r ERCP biliary brush specimens by standard FNA and cytlgy prcedures. Place up t 50 ml f either supernatant fluid r residual fluid frm a liquid cytlgy preparatin such as ThinPrep r SurePrep int supernatant cllectin tube prvided by Interpace Diagnstics. D nt mix supernatants frm different specimens in the same shipping tube. Use additinal tubes if mre than ne specimen is submitted and label each tube with specific cllectin site t distinguish the specimens. Place DO NOT DISCARD sticker nt vial with cytlgy specimen (when sending t Cytlgy Labratry fr prcessing). Cntact Client Services fr rdering infrmatin. Testing requires submissin f a nrmal cntrl. Specimen Strage and Packaging Specimens may be stred refrigerated at 2-8 C until shipped. Use the Interpace Specimen Cllectin Kit t ship the specimens. Specimen Prep fr Interpace Mlecular Testing Cllect fr pancreatic masses, cytlgy, ERCP biliary r pancreas brush specimens. Cytlgy Slides Cytlgy slides, including thse with little cellular material, are acceptable fr analysis. Acceptable fixatives include ethanl, methanl and mst cmmn cytlgy fixatives. Slides stained with Papaniclau f Diff-Quik with cverslips remved are preferred. Interpace Diagnstics can remve cverslip. Hematxylin/Esin stained slides are prblematic due t interference f the analysis by the Hematxylin dye. Please cntact Interpace Diagnstics if n ther materials are available r if there are questins. Send slides with mst representative cells. Please indicate n the requisitin if slide is frm a smear, cell blck, r ThinPrep. Ensure that slides are labeled fr prper identificatin. Pathlgist may mark area(s) f interest n the underside f stained slide(s) using a permanent marker. Specimen Strage The slides may be stred at rm temperature prir t shipment. Cytlgy Brushing Cellular material remaining n a cytlgy brush head after preparatin f smears shuld be prcessed as fllws: Detach prtin f brush head r entire brush head and place int an empty 2 ml plyprpylene screw cap tube cntained in the Interpace Specimen Cllectin Kit. Or After brushing has been placed int vial f cytlgy fixative fr cytlgy evaluatin, vigrusly agitate fr 10 secnds. Aliqut ml int empty screw cap vial Interpace Diagnstics CO-SOP-1007 Page 7 f 13

8 Directry f Labratry Services Fr ptimal results, it is recmmended t use the supplied media frm the Interpace PreservCyt Cllectin kit if using a preservative r buffer. CytRich Red and acetic acid are nt acceptable. Place ne brush head per tube. Use additinal tubes if mre than ne brush head is submitted, and label specifically t distinguish between the cllectin sites. Specimen Strage Specimens may be stred refrigerated at 2-8 C until shipped. Histlgy Testing Use fr PancraGen, BarreGen, Metastases vs. Primary Tumrs (MvP), and Tissue Identity (TI) specimens Specimen Prep fr Histlgy Histlgy Slides Cut nine (9) histlgy sectins (4-5 micrns thick) frm paraffin blcks. Ribbning (placing serial cpies f the same tissue sectin next t each ther) multiple tissue sectins nt a single glass slide is encuraged. Psitive charged slides nt required. One re-cut per blck shuld be stained with Hematxylin/Esin and cver slipped. D nt stain r cver slip the remaining 8 re-cut sectins. Decalcified, bleached, r Zenker s r Buin s fixed tissues are nt acceptable fr testing. Pathlgist may mark area(s) f interest n the underside f stained slide using permanent marker. Unstained slides must be deparaffinized and care shuld be taken t avid ver-baking the specimen. Interpace Diagnstics can prvide this service. Specimen Strage and Packaging The stained and unstained re-cuts may be stred indefinitely at rm temperature prir t shipment and may be shipped at ambient (rm) temperature. Use Interpace Diagnstics Histlgy/Cytlgy Cllectin Kit and cntents fr packaging and shipment f glass micrscpe slides f tissue sectins r cells fr diagnsis. Slides shuld be placed int the prvided rigid plyprpylene slide hlders. D nt use cardbard slide mailers. These hld fur t five micrscpe slides. If a lesser amunt f slides is packaged, use included materials t reduce mvement f slides. D nt allw slides t tuch. PancraGen and BarreGen testing requires submissin f a nrmal cntrl. Paraffin Blcks Paraffin blcks are accepted, but testing will be delayed due t slide prcessing. Interpace Diagnstics can prvide this service. Slide prcessing will entail the fllwing: Nine (9) sectins (4 5 micrns thick). Recuts will be reduced if minimal cells available. One slide will be stained with Hematxylin/Esin and cver slipped. The remaining re-cuts will nt be stained r cver slipped Specimen Strage and Packaging The Paraffin blcks may be stred indefinitely at rm temperature prir t shipment. CEA and Amylase Testing All bdy fluids are accepted fr AccuCEA and Amylase testing D nt submit fluids diluted in any slutin. All specimens fr AccuCEA and Amylase testing shuld be sent in the Interpace Specimen Cllectin Kit and shipped with 2 frzen bricks. Frzen specimens are unacceptable fr AccuCEA and Amylase testing Interpace Diagnstics CO-SOP-1007 Page 8 f 13

9 Ordering Tests Directry f Labratry Services Physicians may rder ThyGenX /ThyraMIR, PancraGen, AccuCEA, Amylase, and Cytlgy, r request specimen strage by cmpleting the apprpriate Interpace Diagnstics requisitin frm. The physician must sign and date the apprpriate requisitin frm and it must be included in the specimen shipment t Interpace Diagnstics. Incmplete infrmatin n the frm may cause a testing delay. Interpace Diagnstics des nt accept standing rders. If yu have questins regarding any test rdering, please cntact Client Services at Please nte: PancraGen mlecular test requests are nt accepted n the fluid chemistry r strage test frm. Test Requisitin Frms Test Requisitin Frms are available by cntacting Client Services at r n the Interpace Diagnstics website at Cmpletin f all fields is required. Please be sure all fields have been cmpleted prir t submitting t Interpace Diagnstics. Please cmplete and submit a separate Test Requisitin Frm fr each patient. Required Dcuments and Reprts Ship specimen(s) with the fllwing dcumentatin: Cmpleted Test Requisitin Frm Patient billing demgraphics Imaging r Endscpy reprt (when apprpriate and if available) Cytlgy/Pathlgy reprt (when apprpriate and if available) If Imaging r Endscpy and Cytlgy/Pathlgy reprt are nt available at time f submissin, please send as sn as available. Specimen Packaging Interpace Specimen Cllectin/Transprt Kits Interpace Specimen Cllectin/Transprt Kits are prvided free f charge fr yur cnvenience and t ensure apprpriate materials are used fr specimen cllectin and shipping. These are t be used nly fr submitting specimens t Interpace Diagnstics. T request an initial r replacement supply f Interpace Specimen Cllectin/Transprt Kits call Client Services at Orders are filled and shipped via FedEx Grund (tw t-three business days) within ne business day f request. Overnight delivery shipping is prvided upn request. Packaging fr ThyGenX /ThyraMIR Specimens Use Interpace Specimen Transprt Kit and cntents fr packaging and shipment. Place specimen vial in a specimen cllectin bag and seal. If placing mre than ne vial in a specimen cllectin bag please clearly label each specimen If sending cytlgy cllectin kit nly, use a single kit per ndule sampling. Refrigeratin is nt required fr string r shipping specimen. Clse kit by tucking flaps int the uter cardbard bx. Put cllectin kit in the FedEx Clinical Pak (shipping bag), remve adhesive strip prtectr, and seal tightly. Call FedEx at (800) t schedule specimen pickup. Packaging fr Pancreatic Cyst Fluid Specimens (PancraGen, Cytlgy, AccuCEA, Amylase testing) Use Interpace Specimen Cllectin Kit and cntents fr packaging and shipment. Once specimens are in a bihazard bag: 2017 Interpace Diagnstics CO-SOP-1007 Page 9 f 13

10 Directry f Labratry Services Place bihazard bag cntaining specimens and dcumentatin int the styrfam shipping cntainer. Up t three (3) bihazard bags frm different cases may be shipped in ne shipping cntainer. Place 2 frzen bricks int the shipping cntainer. Place styrfam lid n the shipping cntainer and clse kit by tucking flaps int the uter cardbard bx. Put cllectin kit in the FedEx Clinical Pak (shipping bag), remve adhesive strip prtectr, and seal tightly. Call FedEx at (800) t schedule specimen pickup. Packaging fr Cyt-centrifugatin Supernatant Pancreaticbiliary Specimens and Cytlgy Brush Specimens Use Interpace Specimen Cllectin Kit and cntents fr packaging and shipment. Once specimens are in a bihazard bag: Place bihazard bag cntaining specimens and dcumentatin int the styrfam shipping cntainer. Up t tw (2) bihazard bags frm different cases may be shipped in ne shipping cntainer. Place 2 frzen bricks int the shipping cntainer. Place styrfam lid n the shipping cntainer and clse kit by tucking flaps int the uter cardbard bx. Put cllectin kit in the FedEx Clinical Pak (shipping bag), remve adhesive strip prtectr, and seal tightly. Call FedEx at (800) t schedule specimen pickup. Packaging fr BarreGen, MvP and Tissue Identity Specimens Use Interpace Histlgy/Cytlgy Cllectin Kit and cntents fr packaging and shipment f glass micrscpe slides f tissue sectins r cells fr diagnsis. Slides shuld be placed int the prvided rigid plyprpylene slide hlders. D nt use cardbard slide mailers. These hld five (5) micrscpe slides. Place slide hlders and/r blcks int the fam insert and put back int shipping cntainer. Up t fur (4) slide hlders (fr a ttal f 20 slides) and three (3) blcks can fit int the fam insert. D nt allw slides t tuch. Refrigeratin is nt required fr string r shipping specimen. Clse kit by tucking flaps int the uter cardbard bx. Put cllectin kit in the FedEx Clinical Pak (shipping bag), remve adhesive strip prtectr, and seal tightly. Call FedEx at (800) t schedule specimen pickup. Shipping Specimens t Interpace Diagnstics Specimens shuld be shipped via FedEx Pririty Overnight delivery t Interpace Diagnstics using prepaid, pre-addressed labels prvided by Interpace Diagnstics. Ship T: Interpace Diagnstics 2515 Liberty Avenue Pittsburgh, PA Ph: Or: Hld At FedEx Interpace Diagnstics Internatinal Dr, Carg 2 Craplis, PA Ph: We accept specimens fr testing Mnday thrugh Friday frm 8:00 AM t 5:00 PM EST. Specimens sent by FedEx n Fridays and checked n the FedEx Airbill fr Saturday Delivery are received n Saturdays fr testing n the next business day. The client is respnsible fr cntacting FedEx t ship the specimens Interpace Diagnstics CO-SOP-1007 Page 10 f 13

11 Billing Infrmatin Directry f Labratry Services Interpace Diagnstics will bill third party payers directly fr insured patients, wherever permitted by gvernment regulatins, payer billing plicies, r cntractual arrangements, as lng as the fllwing infrmatin is prvided: Patient Demgraphic Infrmatin (ie. Name, Date f Birth, Address, etc) Insurance Infrmatin (ie. Insurance Name, Plicy ID, Grup Number, etc) Specimen Cllectin Lcatin (ie. Outpatient, Inpatient, Ambulatry Surgical Center, etc) If the Specimen Cllectin Lcatin is Inpatient, the Discharge Date must als be prvided. Submitting Diagnsis The diagnsis cde r written narrative prvided shuld be cnsistent with the patient s medical recrds. The infrmatin abve may be prvided n the test requisitin r n a patient infrmatin sheet (face sheet) r by attaching a gd quality phtcpy f the patient s insurance cards (frnt and back). If this infrmatin is nt prvided, it may result in a client bill. Our Client Services Department can assist with questins regarding billing requirements Mnday thrugh Friday, 8:00am t 8:00pm EST, and can be reached at Additinal Infrmatin fr Medicare Patients: If mlecular testing is rdered mre than 14 days after patient discharge frm hspital (r specimen cllectin date fr utpatients) Medicare will be billed. If the test rder is PancraGen the rdering physician must identify and indicate factr(s) that affected the time f rdering mlecular testing. Factrs indicated must be cnsistent with the patient s medical recrds. Specimen Viability Service (SVS) Interpace Diagnstics ffers the Specimen Viability Service fr the purpse f maintaining pancreaticbiliary fluids, ERCP brush specimens, the accmpanying cntrl specimens (buccal brush r whle bld sample) and extracted DNA under apprpriate cnditins t ensure their viability fr analysis by the PancraGen mlecular test. Based n the results f an internal stability study f pancreaticbiliary fluids, it was determined that these specimens are nly viable fr a defined perid f time fllwing cllectin (with strage under the cnditins f the Specimen Viability Service). SVS Specimen Submissin Custmers shuld use an Interpace Specimen Cllectin Kit t cllect and ship the specimens (using prepaid, pre-addressed FedEx label) t Interpace Diagnstics. Specimens must be labeled apprpriately as is required fr all clinical specimens with at least tw patient identifiers t include name, SSN/MRN, gender, and/r date f birth. These specimen label identifiers must match the infrmatin n the Requisitin fr First-Line Testing r Strage Frm. Specimens submitted fr Strage nly require a cmpleted Strage Frm. An aliqut f specimens submitted fr Fluid Chemistry testing and/r Cytlgy will autmatically be placed int strage fr pssible future testing. SVS Inventry Reprts Client Services will ntify each physician n a weekly basis f their current inventry f specimens Interpace Diagnstics CO-SOP-1007 Page 11 f 13

12 Directry f Labratry Services SVS Specimen Optins The client has the ptin, at any time, t d ne f the fllwing: If the custmer requests that Interpace Diagnstics perfrm PancraGen testing, a cmpleted Test Requisitin must be sent t Interpace Diagnstics prir t the scheduled date f discard (Specimens fr PancraGen will be discarded after 45 days) as specified by this plicy. If the custmer requests that Interpace Diagnstics frward the specimen t anther labratry fr testing, Interpace Diagnstics will frward the specimen upn receipt f the shipping infrmatin frm the submitting physician at n charge t the custmer. If the custmer requests that Interpace Diagnstics return the specimen, Interpace Diagnstics will return the specimen t the institutin frm which the specimen was shipped at n charge t the custmer. If the custmer shuld indicate that the specimen is t be dispsed f, Interpace Diagnstics will handle the prper dispsal f the specimen. Nte: the specimen will be discarded if n instructin is received frm the rdering physician prir t Day Interpace Diagnstics CO-SOP-1007 Page 12 f 13

13 Directry f Labratry Services Imprtant Cntact Infrmatin General Inquiries: PancraGen : (800) ThyGenX /ThyraMIR : (844) BarreGen : (844) Client Services fax: (412) r (888) Client Services client_services@interpacedx.cm Client billing questins: (877) r InterpaceDiagnstics@mylabbill.cm Patient billing questins: (877) r InterpaceDiagnstics@mylabbill.cm Hurs f peratin: Mnday-Friday 8:00am 8:00pm EST Website: blank test requisitins available Labratry address: 2515 Liberty Ave., Pittsburgh, PA T schedule a FedEx pick-up: (800) FedEx Accunt # Accreditatin: CLIA ID# 39D CAP # Interpace Diagnstics CO-SOP-1007 Page 13 f 13