New lab order for: Nallie Sams

^{Idina Health Network Services}^{Immunodeficiency lab requisition form}

Lab Address

^{Please submit the following Req Forms}

^{LAB USE ONLY}

^{6776 Southwest Freeway, Suite #620

Houston, Tx 77074

Lab Director: Albert Chen M.D.

Phone: 281.378.2116

Fax: 281.466.2483}


	^{Letter of medical necessity (Signed by physician)}

^{Informed consent form (Signed by physician)}

^{SOAP & Progress Note (Signed by physician)}

^{Summary of Active Medications}

^{^{Scanned insurance card copy}}

^{Primary Immunodeficiency Testing Requisition Form}
^{Patient Information}

^Ethnicity

African American	Asian	Caucasian	Hispanic	Jewish(Ashkenazi)	Portuguese	Other

^{Patient Insurance Information}	^{Specimen Information}

Insurance	Self-Pay	Client Bill

Date sample collected

	Buccal Swab
	Other(specify source)

^{Ordering License Physician/Sending Facility Information} ^{(Each listed person will receive a copy of the report)}

^{Statement of Medical Necessity}

^{By submission of this test requisition and accompanying sample(s), I: (i) authorize and direct to perform the testing indicated; (ii) certify that the person listed
as the ordering provider is authorized by law to order the test(s) requested; (iii) certify that any custom panel and/or ordered test(s) requested on this test
requisition form are reasonable and medically necessary for the diagnosis and/or treatment of a disease, illness, impairment, symptom, syndrome or
disorder; (iv) the test results will determine my patient's medical management and treatment decisions of this patient's condition on this date of service;
(v) have obtained this patient's and relatives', when applicable, written informed consent to undergo any genetic testing requested; and (vi) that the full and
appropriate diagnosis code(s) are indicated to the highest level of specificity.}

^{Provider digital signature appears below. Digital signature or free-hand signature shows authorization.}

^{Indication for Testing} ^{(Check all that apply)}

	Diagnostic		Family Hx		Positive or normal control

Other:

Will the patient management be changed depending on the test results?

	Yes		No		Stat Test Date Needed, if Known

^{Clinical Presentation}

Behavior	Conditions	Pedigree/Family Hx	Phenotype	Physical	Symptoms

^{There are many presentations which may not seem like a direct association for disease. Please List the most suspected presentations and attach detailed medical records and/or pedigree.}

^{Panel ID: FT-TP01366 - Comprehensive Primary Immunodeficiency - 471 Genes}

^{ACD, ACP5, ACTB, ADA, ADA2, ADAM17, ADAMTS13, ADAR, AICDA, AIRE, AK2, AP1S3, AP3B1, AP3D1, APOL1, ARMC4, ARPC1B, ATM, ATP6AP1,
B2M, BACH2, BCL10, BCL11B, BLM, BLNK, BLOC1S3, BLOC1S6, BRCA2, BRIP1, BTK, C1QA, C1QB, C1QC, C1R, C1S, C2, C3, C4BPA, C5, C6, C7, C8A, C8B, C8G, C9, CARD11, CARD14, CARD9, CARMIL2, CASP10, CASP8, CAVIN1, CCBE1, CCDC103,
CCDC114, CCDC39, CCDC40, CCDC65, CCNO, CD19, CD247, CD27, CD3D, CD3E, CD3G, CD40, CD40LG, CD46, CD55, CD59, CD70, CD79A, CD79B, CD81, CD8A, CDCA7, CEBPE, CENPF, CFAP298, CFB, CFD, CFH, CFHR1, CFHR2, CFHR3, CFHR4, CFHR5,
CFI, CFP, CFTR, CHD7, CIITA, CLCN7, CLEC7A, CLPB, COG6, COLEC11, COPA, CORO1A, CR2, CREBBP, CSF2RA, CSF2RB, CSF3R, CTC1, CTLA4, CTPS1, CTSC, CXCR4, CYBA, CYBB, DCLRE1B, DCLRE1C, DDX58, DGKE, DHFR, DKC1, DNAAF1, DNAAF2,
DNAAF3, DNAAF4, DNAAF5, DNAH1, DNAH11, DNAH5, DNAI1, DNAI2, DNAJC21, DNAL1, DNASE1L3, DNASE2, DNMT3B, DOCK2, DOCK8, DRC1, DTNBP1, ELANE, EPG5, ERCC2, ERCC3, ERCC4, ERCC6L2, ETV6, EXTL3, F11, F13A1, F13B, F5, F7, F8, F9,
FAAP24, FADD, FANCA, FANCB, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCI, FANCL, FANCM, FAS, FASLG, FAT4, FCGR3A, FCN3, FERMT3, FGA, FGB, FOXN1, FOXP3, FPR1, G6PC, G6PC3, G6PD, GAS8, GATA1, GATA2, GFI1, GINS1, GP1BA, GP1BB,
GP9, GTF2H5, HAX1, HELLS, HPS1, HPS3, HPS4, HPS5, HPS6, HYDIN, HYOU1, ICOS, IFIH1, IFNAR2, IFNGR1, IFNGR2, IGHM, IGLL1, IKBKB, IKZF1, IL10, IL10RA, IL10RB, IL12RB1, IL17F, IL17RA, IL17RC, IL1RN, IL2, IL21, IL21R, IL2RA,
IL2RG, IL36RN, IL7R, INO80, INSR, INVS, IRAK1, IRAK4, IRF2BP2, IRF3, IRF7, IRF8, ISG15, ITCH, ITGAM, ITGB2, ITK, JAGN1, JAK1, JAK2, JAK3, KDM6A, KMT2D, KRAS, LAMTOR2, LAT, LCK, LIG1, LIG4, LPIN2, LRBA, LRRC6, LRRC8A,
LYST, MAGT1, MALT1, MAN2B1, MANBA, MAP3K14, MASP1, MASP2, MBL2, MC2R, MCM4, MEFV, MKL1, MLPH, MOGS, MPL, MPO, MRE11, MS4A1, MSH6, MSN, MTHFD1, MVK, MYD88, MYH9, MYO5A, MYSM1, NBAS, NBN, NCF1, NCF2, NCF4, NCSTN, NFAT5,
NFKB1, NFKB2, NFKBIA, NHEJ1, NHP2, NKX2-5, NLRC4, NLRP1, NLRP12, NLRP3, NME8, NOD2, NOP10, NRAS, NSMCE3, OFD1, ORAI1, OSTM1, OTULIN, PALB2, PARN, PCCA, PCCB, PEPD, PGM3, PI4KA, PIGA, PIH1D3, PIK3CD, PIK3R1, PLCG2, PLEKHM1,
PLG, PMM2, PMS2, PNP, POLA1, POLE, POLE2, PRF1, PRKCD, PRKDC, PROC, PROS1, PSENEN, PSMB8, PSTPIP1, PTEN, PTPRC, RAB27A, RAC2, RAD50, RAD51C, RAG1, RAG2, RANBP2, RASGRP1, RBCK1, RBM8A, RECQL4, RELB, RFX5, RFXANK, RFXAP,
RHOH, RMRP, RNASEH2A, RNASEH2B, RNASEH2C, RNF168, RNF31, RNU4ATAC, RORC, RPGR, RPL11, RPL15, RPL26, RPL35A, RPL36, RPL5, RPS10, RPS15, RPS15A, RPS17, RPS19, RPS24, RPS26, RPS27A, RPS28, RPS29, RPS7, RPSA, RSPH1, RSPH3,
RSPH4A, RSPH9, RTEL1, RUNX1, SAMD9, SAMD9L, SAMHD1, SBDS, SEMA3E, SERPING1, SH2D1A, SH3BP2, SKIV2L, SLC29A3, SLC35A1, SLC35C1, SLC37A4, SLC39A4, SLC46A1, SLC7A7, SLX4, SMARCAL1, SMARCD2, SNX10, SP110, SPAG1, SPINK5, SRP54,
SRP72, STAT1, STAT2, STAT3, STAT5B, STIM1, STK4, STN1, STX11, STXBP2, TAP1, TAP2, TAPBP, TAZ, TBK1, TBX1, TCF3, TCIRG1, TCN2, TERC, TERT, TFRC, THBD, TICAM1, TINF2, TIRAP, TLR3, TMC6, TMC8, TMEM173, TNFAIP3, TNFRSF11A,
TNFRSF13B, TNFRSF13C, TNFRSF1A, TNFRSF4, TNFSF11, TNFSF12, TPP1, TPP2, TRADD, TRAF3, TRAF3IP2, TREX1, TRNT1, TTC37, TTC7A, TYK2, UNC119, UNC13D, UNC93B1, UNG, USB1, USP18, VPS13B, VPS45, WAS, WDR1, WIPF1, WRAP53, XIAP,
XK, ZAP70, ZBTB24, ZMYND10, ZNF341P}

^{Indication(s) for Testing - ICD-10 Codes}

^{INFECTIOUS DISEASES}

	^B20	^{Human immunodeficiency virus[HIV] disease}
	^B59	^{Pneumocystosis}

^{MALIGNANT NEOPLASMS OF LYMPHOID HEMATOPOIETIC AND RELATED TISSUE}

	^C80.2	^{Malignant neoplasm associated with transplanted organ}
	^C88.8	^{Other malignant immunoproliferative diseases}
	^C94.40	^{Acute panmyelosis with myelofibrosis not having achieved remission}
	^C94.41	^{Acute panmyelosis with myelofibrosis in remission}
	^C94.42	^{Acute panmyelosis with myelofibrosis in relapse}
	^C94.6	^{Myelodysplastic disease not classified}

^{MYELODYSPLASTIC SYNDROMES}

	^D46.22	^{Refractory anemia with excess of blasts 2}
	^D47.1	^{Chronic myeloproliferative disease}
	^D47.9	^{Neoplasm of uncertain behavior of lymphoid hematopoietic and related tissue unspecified}
	^D47.Z1	^{Post-transplant lymphoproliferative disorder (PTLD)}
	^D47.Z9	^{Other specified neoplasms of uncertain behavior of lymphoid hematopoietic and related tissue}

^{APLASTIC AND OTHER ANEMIAS AND OTHER BONE MARROW FAILURE SYNDROMES}

	^D61.09	^{Other constitutional aplastic anemia}
	^D61.810	^{Antineoplastic chemotherapy induced pancytopenia}
	^D61.811	^{Other drug-induced pancytopenia}
	^D61.818	^{Other pancytopenia}

^{OTHER DISORDERS OF BLOOD AND BLOOD-FORMING ORGANS}

	^D70.0	^{Congenital agranulocytosis}
	^D70.1	^{Agranulocytosis secondary to cancer chemotherapy}
	^D70.2	^{Other drug-induced agranulocytosis}
	^D70.4	^{Cyclic neutropenia}
	^D70.8	^{Other neutropenia}
	^D70.9	^{Neutropenia unspecified}
	^D71	^{Functional disorders of polymorphonuclear neutrophils}
	^D72.0	^{Genetic anomalies of leukocytes}
	^D72.810	^{Lymphocytopenia}
	^D72.818	^{Other decreased white blood cell count}
	^D72.819	^{Decreased white blood cell count unspecified}
	^D73.81	^{Neutropenic splenomegaly}
	^D75.81	^{Myelofibrosis}
	^D76.1	^{Hemophagocytic lymphohistiocytosis}
	^D76.2	^{Hemophagocytic syndrome infection-associated}
	^D76.3	^{Other histiocytosis syndromes}

^{POSTSURGICAL MALABSORPTION & CONNECTIVE TISSUE RELATED DISORDER}

	^T86.00	^{Unspecified complication of bone marrow transplant}
	^T86.01	^{Bone marrow transplant rejection}
	^T86.02	^{Bone marrow transplant failure}
	^T86.03	^{Bone marrow transplant infection}
	^T86.09	^{Other complications of bone marrow transplant}
	^T86.10	^{Unspecified complication of kidney transplant}
	^T86.11	^{Kidney transplant rejection}
	^T86.12	^{Kidney transplant failure}
	^T86.13	^{Kidney transplant infection}
	^T86.19	^{Other complication of kidney transplant}
	^T86.20	^{Unspecied complication of heart transplant}
	^T86.21	^{Heart transplant rejection}
	^T86.22	^{Heart transplant failure}
	^T86.23	^{Heart transplant infection}
	^T86.290	^{Cardiac allograft vasculopathy}
	^T86.298	^{Other complications of heart transplant}

	^T86.30	^{Unspecified complication of heart-lung transplant}
	^T86.31	^{Heart-lung transplant rejection}
	^T86.32	^{Heart-lung transplant failure}
	^T86.33	^{Heart-lung transplant infection}
	^T86.39	^{Other complications of heart-lung transplant}
	^T86.40	^{Unspecified complication of liver transplant}
	^T86.41	^{Liver transplant rejection}
	^T86.42	^{Liver transplant failure}
	^T86.43	^{Liver transplant infection}
	^T86.49	^{Other complications of liver transplant}
	^T86.5	^{Complications of stem cell transplant}
	^T86.810	^{Lung transplant rejection}
	^T86.811	^{Lung transplant failure}
	^T86.812	^{Lung transplant infection}
	^T86.818	^{Other complications of lung transplant}
	^T86.819	^{Unspecified complication of lung transplant}

	^T86.830	^{Bone graft rejection}
	^T86.831	^{Bone graft failure}
	^T86.832	^{Bone graft infection}
	^T86.838	^{Other complications of bone graft}
	^T86.839	^{Unspecified complication of bone graft}
	^T86.850	^{Intestine transplant rejection}
	^T86.851	^{Intestine transplant failure}
	^T86.852	^{Intestine transplant infection}
	^T86.858	^{Other complications of intestine transplant}
	^T86.859	^{Unspecified complication of intestine transplant}
	^T86.5	^{Complications of stem cell transplant}
	^T86.890	^{Other transplanted tissue rejection}
	^T86.891	^{Other transplanted tissue failure}
	^T86.892	^{Other transplanted tissue infection}
	^T86.898	^{Other complications of other transplanted tissue}
	^T86.899	^{Unspecified complication of other transplanted tissue}

	^T86.90	^{Unspecfied complication of unspecified transplanted organ and tissue}
	^T86.91	^{Unspecified transplanted organ and tissue rejection}
	^T86.92	^{Unspecified transplanted organ and tissue failure}
	^T86.93	^{Unspecified transplanted organ and tissue infectiont}
	^T86.99	^{Other complications of unspecified transplanted organ and tissue}

^{DISORDERS INVOLVING THE IMMUNE MECHANISM}

	^D80.0	^{Hereditary hypogammaglobulinemia}
	^D80.1	^{Nonfamilial hypogammaglobulinemia}
	^D80.2	^{Selective deficiency of immunoglobulin A [IgA]}
	^D80.3	^{Selective deficiency of immunoglobulin G [IgG] subclasses}
	^D80.4	^{Selective deficiency of immunoglobulin M [IgM]}
	^D80.5	^{Immunodeficiency with increased immunoglobulin M [IgM]}

	^D80.6	^{Antibody deficiency with near-normal immunoglobulins or with hyperimmunoglobulinemia}
	^D80.7	^{Transient hypogammaglobulinemia of infancy}
	^D80.8	^{Other immunodeficiencies with predominantly antibody defects}
	^D80.9	^{Immunodeficiency with predominantly antibody defects unspecified}
	^D81.0	^{Severe combined immunodeficiency [SCID] with reticular dysgenesis}
	^D81.1	^{Severe combined immunodeficiency [SCID] with low T- and B-cell numbers}
	^D81.2	^{Severe combined immunodeficiency [SCID] with low or normal B-cell numbers}
	^D81.4	^{Nezelof's syndrome}
	^D81.6	^{Major histocompatibility complex class I deficiency}
	^D81.7	^{Major histocompatibility complex class II deficiency}
	^D81.89	^{Other combined immunodeficiencies}
	^D81.9	^{Combined immunodeficiency unspecified}
	^D82.0	^{Wiskott-Aldrich syndrome}
	^D82.1	^{Di George's syndrome}
	^D82.2	^{Immunodeficiency with short-limbed stature}
	^D82.3	^{Immunodeficiency following hereditary defective response to Epstein-Barr virus}

	^D82.4	^{Hyperimmunoglobulin E [IgE] syndrome}
	^D82.8	^{Transient hypogammaglobulinemia of infancy}
	^D80.8	^{Immunodeficiency associated with other specified major defects}
	^D82.9	^{Immunodeficiency associated with major defect unspecied}
	^D83.0	^{Common variable immunodeficiency with predominant abnormalities of B-cell numbers and function}
	^D83.1	^{Common variable immunodeciency with predominant immunoregulatory T-cell disorders}
	^D83.2	^{Common variable immunodeficiency with autoantibodies to B- or T-cells}
	^D83.8	^{Other common variable immunodeficiencies}
	^D83.9	^{Common variable immunodeficiency unspecified}
	^D84.0	^{Lymphocyte function antigen-1 [LFA-1] defect}
	^D84.1	^{Defects in the complement system}
	^D84.8	^{Other specified immunodeficiencies}
	^D84.9	^{Immunodeficiency unspecified}
	^D89.3	^{Immune reconstitution syndrome}
	^D89.810	^{Acute graft-versus-host disease}
	^D89.811	^{Chronic graft-versus-host disease}

	^D89.812	^{Acute on chronic graft-versus-host disease}
	^D89.813	^{Graft-versus-host disease unspecified}
	^D89.82	^{Autoimmune lymphoproliferative syndrome [ALPS]}
	^D89.89	^{Other specified disorders involving the immune mechanism not elsewhere classified}
	^D89.9	^{Disorder involving the immune mechanism unspecified}

^MALNUTRITION

	^E40	^Kwashiorkor
	^E41	^{Nutritional marasmus}
	^E42	^{Marasmic kwashiorkor}
	^E43	^{Unspecied severe protein-calorie malnutrition}

^{HYPERTENSIVE & KIDNEY RELATED DISEASES}

	^I12.0	^{Hypertensive chronic kidney disease with stage 5 chronic kidney disease or end stage renal disease}
	^I13.11	^{Hypertensive heart and chronic kidney disease without heart failure with stage 5 chronic kidney disease or end stage renal disease}
	^I13.2	^{Hypertensive heart and chronic kidney disease with heart failure and with stage 5 chronic kidney disease or end stage renal disease}
	^N18.5	^{Chronic kidney disease stage 5}
	^N18.6	^{End stage renal disease}

^{ENCOUNTER FOR OTHER POSTPROCEDURAL AFTERCARE}

	^Z48.21	^{Encounter for aftercare following heart transplant}
	^Z48.22	^{Encounter for aftercare following kidney transplant}
	^Z48.23	^{Encounter for aftercare following liver transplant}
	^Z48.2	^{Encounter for aftercare following lung transplant}
	^Z48.280	^{Encounter for aftercare following heart-lung transplant}
	^Z48.290	^{Encounter for aftercare following bone marrow transplant}
	^Z48.298	^{Encounter for aftercare following other organ transplant}

^{ENCOUNTER FOR CARE INVOLVING RENAL DIALYSIS}

	^Z49.01	^{Encounter formatting and adjustment of extracorporeal dialysis catheter}
	^Z49.02	^{Encounter for fitting and adjustment of peritoneal dialysis catheter}
	^Z49.31	^{Encounter for adequacy testing for hemodialysis}
	^Z99.2	^{Dependence on renal dialysis}

^{TRANSPLANTED ORGAN AND TISSUE STATUS}

	^Z94.0	^{Kidney transplant status}
	^Z94.1	^{Heart transplant status}
	^Z94.2	^{Lung transplant status}
	^Z94.3	^{Heart and lungs transplant status}
	^Z94.4	^{Liver transplant status}

	^Z94.81	^{Bone marrow transplant status}
	^Z94.82	^{Intestine transplant status}
	^Z94.83	^{Pancreas transplant status}
	^Z94.84	^{Stem cells transplant status}
	^Z94.89	^{Other transplanted organ and tissue status}

^{Additional ICD-10 Codes, if needed}

^{Informed Consent}

^{For the purposes of this consent, "I", "my", and "your" will refer to me or to my child, including my unborn child, if my child is the person for whom the
healthcare provider has ordered testing.

PURPOSE OF THIS TEST

The purpose of this test is (a) to see if I may have a genetic variant or chromosome rearrangement causing a genetic disorder; or (b) to evaluate the
chance that I will develop or passon a genetic disorder in the future. If I already know the specific gene variant(s) or chromosome rearrangement that
causes the genetic disorder in my family, I agree to inform the laboratory of this information.

WHAT TYPE OF TEST RESULTS CAN I EXPECT FROM GENETIC TESTING?

1. Positive: A change in your DNA was found, which is very likely the cause of your features/symptoms. This is the most straightforward test result, which
can be used as the basis to test other family members to determine their chances of having either the disease or a child with the disease.

2. Negative: No variants were found to explain your symptoms. This does not mean that you do not have a genetic condition. It is still possible that there is a
genetic variant not found by the test that was ordered. Your healthcare provider or genetic counselor may discuss more testing either now or in the future.

3. Variant of Uncertain Significance (VUS): A change in a gene was found. However, we are not sure whether this variant is the cause of your symptoms/-
features. More information is needed. We may suggest testing other family members to help gure out the meaning of the test result.

4. Unexpected Results: In rare instances, this test may reveal an important genetic change that is not directly related to the reason for ordering this test. For
example, this test may nd you are at risk for another genetic condition I am not aware of or it may indicate differences in the number or rearrangement of sex
chromosomes. We may disclose this information to the ordering healthcare provider if it likely aects medical care. Because medical and scientic knowledge
is constantly changing, new information that becomes available may supplement the information Elite Clinical Laboratory used to interpret my results.
Healthcare providers can contact Elite Clinical Laboratory at any time to discuss the classication of an identied variant.
WHAT IS TRIO/DUO-BASED GENETIC TESTING?

For some genetic tests, including samples from the biological parents and/or other biological relatives along with the patient's sample can help with
the interpretation of the test results. These tests are often referred to as "trio tests" since they typically include samples from the patient and both
parents. Samples from relatives should be submitted with the patient�s sample. Clinical information must be provided for the patient and any relative
who submits a sample.
I understand that Elite Clinical Laboratory will use the relative sample(s) when needed for the interpretation of my test results and that my test report
may include clinical and genetic information abouta relative when it is relevant to the interpretation of the test results. I further understand that
relatives will not receive an independent analysis of data nor a separate report.
RISKS AND LIMITATIONS OF GENETIC TESTING

1. In some cases, testing may not identify a genetic variant even though one exists. This may be due to limitations in current medical knowledge or
testing technology.

2. Accurate interpretation of test results may require knowing the true biological relationships in a family. I understand that if I fail to accurately state
the biological relationships in my family, it could lead to incorrect interpretation of the test results, incorrect diagnoses, and/or inconclusive test results.
If genetic testing reveals that the true biological relationships in a family are not as I reported them, including non-paternity (the reported father is not
the biological father) and consanguinity (the parents are related by blood), I agree to have these ndings reported to the healthcare provider who
ordered the test.

3. Although genetic testing is highly accurate, inaccurate results may occur. These reasons include, but are not limited to mislabeled samples, inaccurate reporting of clinical/medical information, rare technical errors, or other reasons.

4. I understand that this test may not detect all of the long-term medical risks that I might experience. The result of this test does not guarantee my
health and that additional diagnostic tests may still need to be done.

5. I agree to provide an additional sample if the initial sample is not adequate.
PATIENT CONFIDENTIALITY AND GENETIC COUNSELING

It is recommended that I receive genetic counseling before and after having this genetic test. I can nd a genetic counselor in my area at www.nsgc.org.
Further testing or additional consultations with a healthcare provider may be necessary.
To maintain condentiality, test results will only be released to the referring healthcare provider, the ordering laboratory, to me, to other healthcare
providers involved in my care, diagnosis and treatment, or to others with my consent or as permitted or required by law. Federal laws prohibit unauthorized disclosure of this information. More information can be found at: www.genome.gov/10002077
INTERNATIONAL SAMPLES

If I reside outside the United States, I attest that by providing a sample for testing, I am not knowingly violating any export ban or other legal restriction
in the country of my residence.
SAMPLE RETENTION

After testing is complete, my sample may be de-identified and be used for test development and improvement, internal validation, quality assurance,
and training purposes. Elite Clinical Laboratory will not return DNA samples to you or to referring healthcare providers, unless specific prior arrangements have been made.
I understand that samples from residents of New York State will not be included in the de-identified research studies described
in this authorization and will not retain them for more than 60 days after test completion, unless specifically authorized by my selection. The authorization is optional,
and testing will be unafected if I do not check the box for the New York authorization language. Elite Clinical Laboratory will not
perform any tests on the biological sample other than those specifically authorized.
DATABASE PARTICIPATION

De-identified health history and genetic information can help healthcare providers and scientists understand how genes afect human health. Sharing this
de-identified information helps healthcare providers to provide better care for their patients and researchers to make new discoveries. Elite Clinical Laboratory
shares this type of information with healthcare providers, scientists, and healthcare databases. Elite Clinical Laboratory will not share any personally identifying
information and will replace the identifying information with a unique code not derived from any personally identifying information. Even with a unique code,
there is a risk that I could be identified based on the genetic and health information that is shared. Elite Clinical Laboratory believes that this is unlikely, though
the risk is greater if I have already shared my genetic or health information with public resources, such as genealogy websites.
EXOME/GENOME SEQUENCING SECONDARY FINDINGS

Applicable Only for Full Exome Sequencing and Genome Sequencing Tests. � Does not pertain to Xpanded� or Slice tests
As many dierent genes and conditions are analyzed in an exome or genome sequencing test, these tests may reveal some findings not directly related
to the reason for ordering the test. Such findings are called "incidental" or "secondary" and can provide information that was not anticipated.
Secondary findings are variants, identified by an exome or genome sequencing test, in genes that are unrelated to the individual's reported clinical features.
The American College of Medical Genetics and Genomics (ACMG) has recommended that secondary findings identied in a specific subset of medically
actionable genes associated with various inherited disorders be reported for all probands undergoing exome or genome sequencing. Please refer to
the latest version of the ACMG recommendations for reporting of secondary findings in clinical exome and genome sequencing for complete details
of the genes and associated genetic disorders. Reportable secondary findings will be confirmed by an alternate test method when needed.
WHAT WILL BE REPORTED FOR THE PATIENT? - All pathogenic and likely pathogenic variants associated with specific genotypes identified in the
genes (for which a minimum of 10X coverage was achieved by exome sequencing or a minimum of 15X coverage was achieved by genome sequencing), as recommended by the ACMG.
WHAT WILL BE REPORTED FOR RELATIVES? - The presence or absence of any secondary finding(s) reported for the proband will be provided for all
relatives analyzed by an exome or genome sequencing test.
LIMITATIONS
- Pathogenic and/or likely pathogenic variants may be present in a portion of the gene not covered by this test and therefore are not
reported. The absence of reportable secondary findings for any particular gene does not mean there are no pathogenic and/or likely pathogenic variants
in that gene. Pathogenic variants and/or likely pathogenic variants that may be present in a relative, but are not present in the proband, will not be identified, or reported.
Only changes at the sequence level will be reported in the secondary findings report. Larger deletions/duplications, abnormal methylation, triplet repeat or other expansion variants,
or other variants not routinely identified by clinical exome and genome sequencing will not be reported.
FINANCIAL AGREEMENT AND GUARANTEE
- For insurance billing, I understand and authorize Elite Clinical Laboratory to bill my health insurance plan on
my behalf, to release any information required for billing, and to be my designated representative for purposes of appealing any denial of benefits. I irrevocably
assign to and direct that payment be made directly to I understand that my out-of-pocket costs may be different than the estimated amount indicated to me
by Elite Clinical Laboratory as part of a benet investigation. I agree to be nancially responsible for any and all amounts as indicated on the explanation of
benets issued by my health insurance plan. If my insurance provider sends a payment directly to me for services performed by Elite Clinical Laboratory on
my behalf, I agree to endorse the insurance check and forward it to Elite Clinical Laboratory within 30 days of receipt as payment towards Elite Clinical
Laboratory claim for services rendered.
MEDICARE

A completed Advance Beneficiary Notice (ABN) is required for Medicare patients.

DIGITAL PATIENT LETTER CONSENT

* Applicable Only for Commercial Insurance

* Estimate is provided by your health insurance company and therefore NO estimate will be sent for any orders placed with federal or state-funded
insurance plans (e.g. Medicare, Medicaid, Tricare, etc.), institutional bill, or patient bill (self-pay).
To provide you with the estimated out-of-pocket expenses related to your test, Elite Clinical Laboratory will send you an email and/or text with the link
to access your personalized Digital Patient Letter.

In order to send this information, we need your consent and agreement to the following items:

1. can use your email address or mobile phone number solely for the purpose of Elite Clinical Laboratory sending your estimatedfinancial obligation.
Text message data rates may apply. is not responsible for undelivered messages due to incorrect or illegible contact information.
2. will send you an email and/or text message containing a link to view your personalized Patient Letter that includes the test out-of-pocket estimate. The link
is time-sensitive and will only be available for 72 hours from the time the message is sent. In order to view the estimate, you must click the link in the message.
3. If you take no action, Elite Clinical Laboratory will assume that you agree to move ahead with testing and will bill your health insurance. You can
approve testing with insurance, switch to self-pay, or cancel the test via the link within the given 72-hour window. In turn, Elite Clinical Laboratory if
receives your sample(s) and the billing method hasn't been changed, or the test hasn't been cancelled, we will move ahead with testing as ordered, and
you will be responsible for any out-of-pocket costs for the completion of the test(s).}

^{STOP Patient Signature}

^{I hereby assign all rights and benets under my health plan and all rights and obligations that I and my dependents have under my health plan to
Elite Clinical Laboratory its assigned aliates and authorized representatives for laboratory services furnished to me by Elite Clinical Laboratory
I irrevocably designate, authorize and appoint Elite Clinical Laboratory or its assigned aliates and their authorized representatives as my true
and lawful attorney-in-fact for the purpose of submitting my claims, obtain a copy of my health plan document, Summary Plan Description, disclosure, appeal,
litigation or other remedies in accordance with the benets and rights under my health plan and in accordance with federal or state
laws. If my health plan fails to abide by my authorization and makes payment directly to me, I agree to endorse the insurance check and forward it
to Elite Clinical Laboratory immediately upon receipt. I hereby authorize Elite Clinical Laboratory its assigned aliates and authorized representatives to contact
me or my health Plan/administrator for billing or payment purposes by phone, text message, or email with the contact
information that I have provided to Elite Clinical Laboratory, in compliance with federal and state laws. Elite Clinical Laboratory, its assigned
aliates and their authorized representatives may release to my health plan administrator, my employer, and my authorized representative my
personal health information for the purpose of procuring payment of Elite Clinical Laboratory and for all the laboratory services. I understand
the acceptance of insurance does not relieve me from any responsibility concerning payment for laboratory services and that I am nancially
responsible for all charges whether or not they are covered by my insurance.}

^{STOP ORDERING PHYSICIAN SIGN HERE}

^{I attest that this test is medically necessary for the diagnosis or detection of a disease or disorder and that the results will be used in medical management and care decisions for the patient.
Furthermore, all information on this Requisition Form is true to the best of my knowledge. I agree to provide
the Care Plan notes and Letter of Intent for this order if the insurance requests the lab to gather the medical necessity for any reason}