Technical Update • August 2015 - Cleveland Clinic Laboratories

Cleveland Clinic Laboratories

Technical Update ? August 2015

Cleveland Clinic Laboratories is dedicated to keeping you updated and informed about recent testing changes. That's why we are happy to provide this technical update on a monthly basis. Recently changed tests are bolded, and could include revisions to methodology, reference range, days performed or CPT code. For your convenience, tests are listed alphabetically and the order and billing codes are provided. If you wish to compare the new information with previous test information, refer to the Test Directory, which can be accessed at . Deleted tests and new tests are listed separately. Please update your database as necessary. For additional detail, contact Client Services at 216.444.5755 or 800.628.6816 or via email at clientservices@.

Fee CPT Stability DaSypsePcSeipmTrRefeoecsernitfamCeDlRMroeeIimedsnenqc/tfpcNRuhooeorioneernmdpwRteeioomananlrTtunotetie(oeeggnssnddeytt) NaBOmilrledineCgrhCCaoonddgeee

Test UpPdaagtee #

Summary of Changes by Test Name

4 4 18 4 16

4 18 19

5, 19 5 5 5, 6 6 6 19 6, 7, 18 7 7 19 19

10% Neutral Buffered Formalin Acetylcholine Receptor Modulating Ab Adenovirus 40-41 Antigens by EIA Alcohols Alpha Globin (HBA1 & HBA2) Deletion/Duplication Aluminum Aminolevulinic Acid (ALA) Urine Anaplasma phagocytophilum (HGA) Antibodies, IgG and IgM Babesia Microti IgG & IgM Abs BCR/ABL Kinase Domain Mutation Analysis Bilirubin, Total Blastomyces Antigen C Telopeptide, Beta Cross Linked Cadmium Exposure Panel, OSHA Cannabinoids, Serum Cocaine & Benzoylecgonine, Quant

Complement Factor B Cryptococcus Antibody Cyclic AMP, Plasma Cyclic AMP, Nephrogenous

9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 |

1

Fee CPT Stability DaSypsePcSeipmTrRefeoecsernitfamCeDlRMroeeIimedsnenqc/tfpcNRuhooeorioneernmdpwRteeioomananlrTtunotetie(oeeggnssnddeytt) NaBOmilrledineCgrhCCaoonddgeee

Test UpPdaagtee #

Summary of Changes by Test Name

19

Cyclic AMP, Urine

7

Cytomegalovirus DNA Detection &

Quantitation by PCR

7

Disopyramide

18

Ethosuximide

8

Ethyl Glucuronide, Urine reflex to

Confirm/Quant

8

FISH for 22q11.2 Del, VCF, DiGeorge

16

FISH for Aggressive B-cell Lymphoma

8

FISH for BCL2 (18q21), Tissue

8

FISH for BCL6 (3q27), Tissue

9

FISH for IGH/MYC/CEP8, Tissue

9

FISH for MYC (8q24), Tissue

9

FISH Neuroblastoma 2p24 MYCN Amp

9

FTA Antibodies, CSF

9

Galactose-1-Phosphate

10

Galactose-1-Phosphate, Uridyl Transferase

10

GLA Gene Testing in Fabry Disease

10

Hemoglobin A1C

19

Hemoglobin, Serum

10

Hemoglobinopathy Evaluation

19

Hirsutism Evaluation Panel

19

Histoplasma Antigen by EIA, Body Fluids

19

Histoplasma Antigen by EIA, Serum

17

Histoplasma capsulatum Antigen

18

HIV PhenoSense GT

19

HLA-A

19

HLA-B

18

Human Anti-Mouse Abs

4

ICD-10 codes

10

Islet Cell Antibody

10

Kappa, Free, Serum

11

Kappa/Lambda, Free, Serum

11

Lactate Dehydrogenase

11

Lambda, Free, Serum

11

Leptin

11

Listeria Antibody

19

Macroprolactin

19

Malaria Antibody, IgG

11

Methanol

11

Neisseria gonorrhoea Antibodies, Total

11

Neuron Specific Enolase, CSF

19

Neuronal Nuclear Ab IgG by IFA, Reflex & IB

12

Neuronal Nuclear Abs IgG by Immunoblot

9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 |

2

Fee CPT Stability DaSypsePcSeipmTrRefeoecsernitfamCeDlRMroeeIimedsnenqc/tfpcNRuhooeorioneernmdpwRteeioomananlrTtunotetie(oeeggnssnddeytt) NaBOmilrledineCgrhCCaoonddgeee

Test UpPdaagtee #

Summary of Changes by Test Name

17, Nonalcoholic Steatohepatitis (NASH)

18

FibroSURE

19

Nuclear Ab IgG by IFA, IgG

12

Opiates Confirmation, Quantitation,

Serum/Plasma

19

Organic Acids, Plasma

12

OSHA Zinc Protoporphyrins

12

OVA1? Test

12

P53 Mutation Analysis

13

Paraneoplastic Syndrome Ab Panel

with Reflex

13

PDGFRB/TEL Translocation (5;12) for

Chronic Myelomonocytic Leukemia, FISH

18

pH, Fecal

13

Plasma Thymidine Determination

18

Procainamide/NAPA

13

PRO-PredictR Metabolites

13

Protriptyline

13, Purine Profile, Urinary 14

14

Reducing Substances, Stool

14

Respiratory Chain Complexes, Fibroblast

14

Reticulin Antibody, IgA with reflex to Titer

14

Rett Syndrome

14

ssDNA Antibody, IgG

14

T cell V-Beta by Flow Cytometry

14

Tapentadol & Metabolite Confirm/

Quantitation, Urine

18

Teichoic Acid Antibodies

18

THC Metabolites, Serum/Plasma

15, Thiopurine Methyltransferase (TPMT) 18

15

Urticaria-Induced Basophil Activation

15

Varicella Zoster by PCR

15

VW Multimer Panel

16

ZAP-70 Analysis by Flow Cytometry

9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 |

3

Standardization of Fixatives to 10% Neutral Buffered Formalin

Standardization in medicine is now well recognized as an important tool in helping to enhance patient management. At the Cleveland Clinic Laboratories, we recognize the need for standardizing multiple variables, including pre-analytic variables such as tissue fixation. Variables associated with tissue fixation include time to fixation, type of fixative, and duration of tissue fixation. This standardization protocol has come to play even a bigger role in ancillary studies, such as immunohistochemistry and molecular testing, to insure consistent and reproducible results. For the purpose of supplying and using the same type of fixative with all of our clients and across all Cleveland Clinic Laboratories locations, we are switching your current supply of Acid Alcohol 10% Formalin to 10% Neutral Buffered Formalin. This switch should have no effect on your storage protocols or safety procedures. Please contact Client Services by calling 800.628.6816 for the new 10% Neutral Buffered Formalin and remove and dispose of any old supplies in your current inventory.

ICD-10 Update

As of October 1, 2015: ICD-10 will be in effect and mandatory. The federal government, through the Centers for Medicare & Medicaid Services, is driving the health care industry to upgrade diagnosis and procedure coding standards from ICD-9 to ICD-10. ICD-10 will require additional documentation specificity to support patient care. Due to the increased specificity, the 18,000 ICD-9 codes will translate into 140,000 IDC-10 codes. Cleveland Clinic Laboratories is dedicated to providing high quality testing and excellence in service for you and your patients throughout this transition. Therefore, it is important to remember to provide the appropriate ICD-10 code on and after October 1, 2015 to ensure that your practice remains compliant with this mandate and avoids any reimbursement or billing issues. To order new requisitions, please contact Client Services at 800.628.6816.

Test Changes

Test Name Acetylcholine Receptor Modulating Ab Alcohols

Aluminum

Order Code ACEMOD ALCOS

ALUM

Billing Code 76084

Change

Specimen Requirement: 0.5 mL serum from a serum separator tube; Minimum: 0.3 mL; Remove serum from cells ASAP; Refrigerated CPT: 83516

Effective Date 9/3/15

90156

Specimen Requirement: 2 mL serum from a red top tube; Do not use serum separator tubes; Separate serum from cells ASAP or within 2 hours of collection; Submit specimen in a tightly capped standard transfer tube; Refrigerated

*OR* 2 mL plasma from an EDTA lavender top tube; Do not use plasma separator tubes; Separate plasma from cells ASAP or within 2 hours of collection; Submit specimen in a tightly capped standard transfer tube; Refrigerated

*OR* 2 mL plasma from a potassium oxalate/sodium fluoride gray top tube; Do not use plasma separator tubes; Separate plasma from cells ASAP or within 2 hours of collection; Submit specimen in a tightly capped standard transfer tube; Refrigerated

Stability: (after separation from cells) Ambient: 1 week Refrigerated: 2 weeks Frozen: 1 month

8/17/15

75004

Specimen Requirement: 2 mL serum from a no additive navy blue top tube; Minimum: 0.5 mL; Carefully clean skin with an alcohol swab prior to collection. Use powder less gloves. Do not use serum separator tubes; Remove serum from cells ASAP and aliquot into a trace metal free transport tube (ARUP #43116). These transport tubes are available by calling Client Services at 800.628.6816 or 216.444.5755.

8/17/15

9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 |

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Test Changes (Cont.)

Test Name Babesia Microti IgG & IgM Abs

BCR/ABL Kinase Domain Mutation Analysis Bilirubin, Total

Order Code BMICGM

KINASE TBIL

Billing Code 81936

Change

Special Information: Useful if Giemsa stain is negative, but high suspicion of babesiosis exists. Will not detect B. duncani or strain M0-1. Elevated antibody levels to B. microti indicate exposure to the organism. Human babesiosis infection is transmitted by the bite of an infected ixodes tick or less frequently from transfusion with blood from an infected donor. Definitive diagnosis is made by identifying intraerythrocytic organisms in peripheral blood. In patients with low parasitemia, antibody detection by IFA is recommended.

Specimen Requirement: 1 mL serum from a serum separator tube; Minimum: 0.1 mL; Remove serum from cells ASAP or within 2 hours of collection; Refrigerated

*OR* 1 mL serum from a red top tube; Minimum: 0.1 mL; Remove serum from cells ASAP or within 2 hours of collection; Refrigerated

*OR* 1 mL plasma from an EDTA lavender top tube; Minimum: 0.1 mL; Remove plasma from cells ASAP or within 2 hours of collection; Refrigerated

*OR* 1 mL plasma from a sodium or lithium heparin green top tube; Minimum: 0.1 mL; Remove plasma from cells ASAP or within 2 hours of collection; Refrigerated

*OR* 1 mL plasma from an ACD yellow top tube; Minimum: 0.1 mL; Remove plasma from cells ASAP or within 2 hours of collection; Refrigerated

Stability: (After separation from cells) Ambient: 48 hours Refrigerated: 2 weeks Frozen: 1 year (avoid repeated freeze/thaw cycles)

Days Performed: Monday, Wednesday, Saturday

Reported: 2?6 days

Effective Date 9/24/15

84529

Special Information: If BCR/ABL1 transcripts are not detected by qualitative RT-PCR, the sequence analysis portion of the test is not performed. The lab will order BCR/ABL Kinase Domain RT-PCR (KDPCR) and result. KINASE will then be credited and resulted as "see BCR/ABL Kinase Domain RT-PCR result from (specimen collection date and time)"

8/6/15

35008

Reference Range:

0?30 days: Results are flagged as abnormal due to the agerelated nature of reference intervals in this patient population. Clinician review of acceptable bilirubin levels and risk categories is recommended using age-related or other pertinent reference information (e.g. Bhutani nomograms). Urgent Range: > 15.0 mg/dL

1?11 months: 0.0?1.5 mg/dL 1?99 years: 0.0?1.5 mg/dL

8/27/15

Blastomyces Antigen BLAS

89393

Specimen Requirement: 2 mL serum from a serum separator tube; Minimum: 1.2 mL; Refrigerated

*OR* 2 mL plasma from an EDTA lavender top tube; Minimum: 1.2 mL; Refrigerated

*OR* 2 mL plasma from a sodium or lithium heparin green top tube; Minimum: 1.2 mL; Refrigerated

*OR* 2 mL Bronchioalveolar lavage (BAL) in a sterile container; Minimum: 0.5 mL; Refrigerated

*OR* 2 mL cerebrospinal fluid (CSF) in a sterile container; Minimum: 0.8 mL; Refrigerated

(continued on page 6)

8/27/15

9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 |

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Test Changes (Cont.)

Test Name Blastomyces Antigen (continued from page 5)

C Telopeptide, Beta Cross Linked Cadmium Exposure Panel, OSHA

Cocaine & Benzoylecgonine, Quant

Order Code CTELO CADEXR

COCAIN

Billing Code

Change

*OR* 2 mL serum from a red top tube; Minimum: 1.2 mL; Refrigerated

*OR* 2 mL random urine in a sterile container; Minimum: 0.5 mL; Refrigerated

Stability: Ambient: 2 days Refrigerated: 2 weeks Frozen: Not available

Days Performed: Monday?Friday

Reported: 4?7 days

84398

Specimen Requirement: 1 mL serum from a serum separator tube; Minimum: 0.4 mL; Collect before 10 a.m.; Patient should be fasting; Frozen

*OR* 1 mL serum from a red top tube; Minimum: 0.4 mL; Collect before 10 a.m.; Patient should be fasting; Frozen

81903

For Interfaced Clients Only: Test build for this assay will need to be modified

Components: Cadmium, Blood Cadmium, Ur Ratio to CRT Cadmium Ur, per volume Beta-2 Microglobulin Ratio to CRT Beta-2 Microglobulin, Ur (?g/L) Creatinine, Urine?per volume pH, Ur

Specimen Requirement: 7 mL whole blood in an EDTA navy blue top tube; Minimum: 0.5 mL; Collect both whole blood and urine sample on the same day; Refrigerated

*AND*

30 mL random urine in a clean trace metal free container; Minimum: 12 mL; Pour off three aliquots from random specimen. For B-2-Microglobulin pour off 3 mL urine; Minimum: 3 mL; Adjust pH to 6?8 using 1 M HCl or 5% NaOH, label for B-2Microglobulin testing and freeze ASAP. Refrigerate other two aliquots; label one 7 mL aliquot for Cadmium; Minimum: 0.5 mL; and one 2 mL aliquot for Creatinine; Minimum: 0.5 mL

Reference Range: Cadmium, Blood: 0.0?5.0 ?g/L Creatinine, Urine?per volume: Not established Cadmium, Ur, per volume: 0.0?2.6 ?g/L Cadmium, Ur Ratio to CRT: 0.0 3.0 ?g/g crt Beta-2 Microglobulin Ur: 0?300 ?g/L Beta-2 Microglobulin Ratio to CRT: 0?300 ?g/g crt

76518

For Interfaced Clients Only: The test build for this assay will need to be modified

Includes: Cocaine Benzoylecgonine

Clinical Information:

Reporting Limit: Cocaine: 30 ng/mL Benzoylecognine: 30 ng/mL

Critical Value?High: Cocaine: 500 ng/mL Benzoylecognine: 500 ng/mL

(continued on page 7)

Effective Date 9/27/15 9/22/15

8/17/15

9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 |

6

Test Changes (Cont.)

Test Name

Cocaine & Benzoylecgonine, Quant

(continued from page 6)

Order Code

Billing Code

Change

Specimen Requirement: 5 mL serum from a red top tube; Minimum: 2 mL; Refrigerated

*OR* 5 mL plasma from a sodium or lithium heparin green top tube; Minimum: 2 mL; Refrigerated

Stability: Ambient: 3 days Refrigerated: 2 weeks Frozen: 6 months

Days Performed: Sunday?Saturday

Reported: 6?7 days

Effective Date

Complement Factor B

Cryptococcus Antibody

C3PA

75061

CRYPAB

89349

Cytomegalovirus DNA Detection & Quantitation by PCR

CMVQNT

90605

Disopyramide

DISOP

34032

Days Performed: Monday, Wednesday, Friday

Reported: 5?8 days

Special Information: Cryptococcal antibody testing is not recommended for the diagnosis of acute cryptococcal infection. Cryptococcus Antigen Detection testing (test code CAD) is the preferred method.

Special Information: If EDTA plasma was not separated from red cells within 6 hours of collection and transported refrigerated then the manufacturer's requirements for the IVD reagent system have not been met and the following statements apply. "This test was developed and its performance characteristics determined by Cleveland Clinic's Robert J. Tomsich Pathology and Laboratory Medicine Institute (RT-PLMI). It has not been cleared or approved by the FDA. RT-PLMI is regulated under CLIA as qualified to perform high complexity testing. This test is used for clinical purposes. It should not be regarded as investigational or for research."

Specimen Requirement: 2 mL plasma from an EDTA lavender top tube; Minimum: 1 mL; Centrifuge, aliquot and refrigerate ASAP. Plasma must be separated from whole blood within 6 hours of collection by centrifugation. Transfer plasma to a sterile, screwcapped polypropylene tube; Refrigerated

*OR* 2 mL plasma from an EDTA pink top tube; Minimum: 1 mL; Centrifuge, aliquot and refrigerate ASAP. Plasma must be separated from whole blood within 6 hours of collection by centrifugation. Transfer plasma to a sterile, screw-capped polypropylene tube; Refrigerated

Specimen Requirement: 1 mL serum from a red top tube; Minimum: 0.5 mL; Do not use serum separator tubes; Separate serum from cells within 2 hours of collection; Please provide the following information, if available:

1. Dose?List drug amount and include the units of measure 2. Route?List the route of administration (IV, oral, etc.) 3. Dose Frequency?Indicate how often the dose is administered (per day, per week, as needed, etc.) 4. Type of Draw?Indicate the type of blood draw (Peak, Trough, Random, etc.)

Transport Refrigerated

*OR* 1 mL plasma from an EDTA lavender top tube; Minimum: 0.5 mL; Do not use plasma separator tubes; Separate plasma from cells within 2 hours of collection; Please provide the following information, if available: 1. Dose?List drug amount and include the units of measure 2. Route?List the route of administration (IV, oral, etc.) 3. Dose Frequency?Indicate how often the dose is administered (per day, per week, as needed, etc.) 4. Type of Draw?Indicate the type of blood draw (Peak, Trough, Random, etc.)

Transport Refrigerated

Reference Range: 2.0?5. 0 ?g/mL Toxic: > 6.0 ?g/mL

8/17/15 7/16/15 9/29/15

8/17/15

9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 |

7

Test Changes (Cont.)

Test Name Ethyl Glucuronide, Urine reflex to Confirm/Quant FISH for 22q11.2 Del, VCF, DiGeorge

FISH for BCL2 (18q21), Tissue

FISH for BCL6 (3q27), Tissue

Order Code UEGLUC DGEORG

TBCL2F TBCL6F

Billing Code 89509

Change

Days Performed: Sunday?Saturday Reported: 2?5 days CPT: 80302

Effective Date 9/3/15

82932

For Interfaced Clients only: Test build for this assay will need to be modified

Special Information: Patients residing in New York State must sign an informed consent form. TESTING ALGORITHM: This test only includes a charge for professional interpretation of results and does not include charges for probe application or analysis. Charges will be incurred for application of all probes applied. Analysis charges will be incurred based on the number of cells analyzed per probe set. If no cell are available for analysis, no analysis charges will be incurred.

Specimen Requirement: 5 mL whole blood in a sodium heparin green top tube; Minimum: 2 mL; Provide reason for referral with specimen; Ambient

*OR* 20?25 mL amniotic fluid in a sterile container; Collect specimen in sterile syringe, discard first 2 mL and send remainder in sterile container. Collect during 14?18 weeks gestation. Provide gestational age at time of amniocentesis and reason for referral with specimen; Refrigerated

*OR* 30 mg chorionic villus in transport medium; Refrigerated

*OR* 4 mm skin biopsy in a sterile container; Use Hank's balanced salt solution, Ringer's solution or normal saline in container. Do not handle specimen with hands; Refrigerated

Days Performed: Sunday?Saturday

Reported: 3?8 days

CPT: 88271x2, 88275

8/3/15

84408

Test Name: Previously FISH for BCL2 Translocations

Specimen Requirement: Four electrostatically charged slides with unstained 4 ?m formalin fixed tissue sections; Tissue must contain representative tumor; B5 or Prefer fixative is not acceptable; Ambient

*OR* One paraffin block, formalin fixed, containing representative tissue in a clean container; B5 or Prefer fixative is not acceptable; Ambient

Days Performed: 3 days per week

Reported: 7 days (excludes Cleveland Clinic observed holidays)

CPT: 88377

9/23/15

87605

Test Name: Previously FISH for BCL6 Translocations

Specimen Requirement: One paraffin block, formalin fixed, containing representative tissue in a clean container; B5 or Prefer fixative is not acceptable; Ambient

*OR* Four electrostatically charged slides with unstained 4 ?m formalin fixed tissue sections; Tissue must contain representative tumor; B5 or Prefer fixative is not acceptable; Ambient

Days Performed: 3 days per week

Reported: 7 days (excludes Cleveland Clinic observed holidays)

CPT: 88377

9/23/15

9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 |

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