Cleveland Clinic Laboratories

Transcription

1 Cleveland Clinic Laboratories Technical Update February 2016 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 clevelandcliniclabs.com. Deleted tests and new tests are listed separately. Please update your database as necessary. For additional detail, contact Client Services at or or via at clientservices@ccf.org. Component Change(s) Specimen Requirement Test Update Page # Special Information Test Discontinued New Test Name Change Billing Code Order Code Days Performed/Reported Reference Range Methodology Stability Summary of Changes by Test Name 3 Angiotensin Converting Enzyme 3 Angiotensin Converting Enzyme, CSF 10 Bacterial Vaginosis Scored Gram Stain & Candida Smear 3 Bioavailable Testosterone/SHBG, Adult Male 3 Blood Parasites 3 Body Fluid, Misc. Test 10 BRAF Gene Analysis 3 Buprenorphine and Metabolites, Quant, serum/plasma 3 CEA, Fluid 11 Chloramphenicol 3 Complement Component Level 3A 3 Complement Component Level 4A 3 Digoxin, Free 3 F-2 Isoprostane/Creatinine Ratio 11 HIV-1 Qualitative Test by PCR 4 Immunoglobulin A Subclasses 1 & 2 4 JAK2 Exon Sequencing 11 KIT Gene Analysis 11 KRAS Gene Analysis 4 Lactate Dehydrogenase, CSF CPT Fee 9500 Euclid Avenue Cleveland, Ohio clevelandcliniclabs.com 1

2 Component Change(s) Specimen Requirement Test Update Page # Special Information Test Discontinued New Test Name Change Billing Code Order Code Days Performed/Reported Reference Range Methodology Stability Summary of Changes by Test Name 4 Miscellaneous GC Screen 4 Nitrogen, Total, Feces 5, 11 Osmolality, Body Fluid 5 Oxcarbazepine 5 Porphobilinogen Screen 5 Raji Cell immune Complex Assay 5 Sulfonylurea Hypoglycemia Panel, Quantitative, Urine 5 Uric Acid, Body Fluid 6 West Nile Virus Antibody Panel CSF 6, 7 West Nile Virus Antibody Panel Serum 7 West Nile Virus IgG, CSF 8 West Nile Virus IgG, Serum 8, 9 West Nile Virus IgM, CSF 9 West Nile Virus IgM, Serum CPT Fee Our New Financial System Goes Live on February 1 Our new financial system, powered by TELCOR, goes live on February 1. Some new features of this system are the ability to pay bills online via a patient web portal, new formats for both patient and client statements, and a new auto-faxing system that will send an alert to physician offices for missing information. For more information, please see our Billing page at clevelandcliniclabs.com/contact-us/business-office Euclid Avenue Cleveland, Ohio clevelandcliniclabs.com 2

3 Test Changes Angiotensin Converting Enzyme ACE Special Information: Grossly hemolyzed samples will be rejected. Specimen Requirement: 1mL serum from a serum separator tube; Grossly hemolyzed samples will be rejected; Refrigerated 1/11/16 Angiotensin Converting Enzyme, CSF CACE Special Information: Hemolyzed samples will be rejected. 1/11/16 Bioavailable Testosterone/SHBG, Adult Male BTESTM Test name: Previously Bioavail Testo/SHBG, Adult male Specimen Requirement: 2mL serum from a serum separator tube; Minimum: 0.6mL; Collect between 6-10am; Refrigerated *OR* 2mL plasma from a lithium heparin green top tube; Minimum: 0.6mL; Collect between 6-10am; Refrigerated 3/22/16 Blood Parasites BLDPAR Special Information: Indicate travel history on the requisition. Peripheral blood should be drawn prior to the onset of chills, if possible. Transport to Main campus within 4 hours. Use STAT courier when necessary. Rapid results can be critical to establishing appropriate therapy. Order will include a rapid screening immunochromatographic assay, microscopy (thick and thin smears) and pathologist review of all microscopic results. Preliminary results will be reported within hours. 4/7/16 Body Fluid, Misc. Test Buprenorphine and Metabolites, Quant, serum/plasma FMISCT Special Information: Please identify the test to be performed. This test is to be utilized for any body fluid test request which is defined for other specimen types.cpt codes and price will vary depending on the specimen source and test requested. Ambient: Varies Refrigerated: Varies Frozen: Varies SBUP Norbuprenorphine, Serum/Plasma (NORBUP): 0-99 Years: 1 ng/ml Buprenorphine Serum/Plasma (BUPREN): 0-99 Years: 1 ng/ml Days reported: 2-6 days 3/30/16 2/16/16 CEA, Fluid CEAFL For Interfaced Clients Only: Test build will need to be modified Specimen Requirement: 1mL Cerebrospinal fluid (CSF) in a clean container; Centrifuge to remove cellular material; Refrigerated *OR* 1mL pericardial fluid in a clean container; Centrifuge to remove cellular material; Refrigerated *OR* 1mL peritoneal fluid in a clean container; Centrifuge to remove cellular material; Refrigerated *OR* 1mL pleural fluid in a clean container; Centrifuge to remove cellular material; Refrigerated *OR* 1mL pancreatic fluid in a clean container; Centrifuge to remove cellular material; Refrigerated Refer to 2/16/16 Complement Component Level 3A Complement Component Level 4A COMP3A Test Name: Previously Complement Component 3A 2/16/16 COMP4A Test Name: Previously Complement Component 4A 2/16/16 Digoxin, Free DIGFR CPT: 80163x1 3/30/16 F2 Isoprostane/ Creatinine Ratio F CPT: 82542x1, 82570x1 1/18/ Euclid Avenue Cleveland, Ohio clevelandcliniclabs.com 3

4 Immunoglobulin A Subclasses 1 & 2 IGA Immunoglobulin A (IGA12A) 0-30 days: 1-7 mg/dl 1 month: 1-53 mg/dl 2 months: 3-47 mg/dl 3 months: 5-46 mg/dl 4 months: 4-72 mg/dl 5 months: 8-83 mg/dl 6 months: 8-67 mg/dl 7-8 months: mg/dl 9-11 months: mg/dl 1 year: mg/dl 2 years: mg/dl 3 years: mg/dl 4 years: mg/dl 5-7 years: mg/dl 8-9 years: mg/dl >= 10 years: mg/dl Reference ranges for IgA, Subclass 1 and IgA, Subclass 2 will remain unaffected. 2/16/16 JAK2 Exon Sequencing JAKNON CPT: 81403x1, G0452x1 1/11/16 Lactate Dehydrogenase, CSF Miscellaneous GC Screen CSFLDH For Interfaced Clients Only: Test build will need to be modified Order Code: Previously CLDH Special Information: Refer to aruplab.com/bodyfluids for clinical indications and interpretive information Specimen Requirement: 1mL cerebrospinal fluid (CSF); Minimum: 0.2mL; Centrifuge to remove cellular material; Refrigerated Refer to report Days reported: 2-3 days MISCGC Clinical Information: Because of the labile nature of the organism, a negative culture does not rule out N. gonorrhoeae infection. Specimens are screened for N. gonorrhoeae only. Overgrowth by normal microbiota may make it impossible to rule out N. gonorrhoeae. False negative results may occur with delayed transport. Special Information: Molecular assays are the most sensitive method for diagnosis of N. gonorrhoeae infection. Culture is recommended if the relevant specimen type is not validated for a molecular assay or if susceptibility testing is desired (susceptibility testing must be requested). In legal cases related to sexual abuse, culture may be needed. Urine is not recommended for culture of N. gonorrhoeae from women. Urine has reasonable sensitivity for men if a first morning-voided specimen (not mid-stream) is obtained. Specimen Requirement: 1 throat swab; In a sterile container. Order must specify screen for Neisseria gonorrhoeae. Specimen must not be refrigerated. If the specimen is directly inoculated on Martin Lewis medium, it should be transported to the laboratory in a CO2 biobag.; Ambient *OR* 0.5mL or 1 genital swab; 0.5mL or 1 swab of body fluid, discharge, pus, genital trace, etc. sent in sterile container or sterile culturette.; Ambient 3/30/16 3/31/16 Nitrogen, Total, Feces NITF Days performed: Tuesday, Friday 1/18/ Euclid Avenue Cleveland, Ohio clevelandcliniclabs.com 4

5 Osmolality, Body Fluid FLOSM For Interfaced Clients Only: Test build will need to be modified Order Code: Previously FOSM Clinical Information: Osmolality is an index of the solute concentration. It is determined by the number and not by the nature of the particles in solution. Dissolved solutes change the physical properties of solutions; they increase the osmotic pressure and decrease freezing point. Body fluids have the same osmolality as a corresponding serum specimen taken at the same time. "True body fluids" include: ascitic, cerebrospinal, hydrocele, edema, pericardial, pleural, spermatocele and synovial fluids. Secretions not in equilibrium with the extra-cellular fluids of the body include gastric juice, saliva and sweat. Serum osmolality is normally between 275 to 295 mosm/kg; it increases with dehydration and decreases with overhydration. Urine osmolality reflects the ability of the kidney to maintain tonicity and water balance. The normal kidney can concentrate urine to 800 to 1,400 mosm/kg, and with excess fluid intake, a minimal osmolality of 40 to 80 mosm/kg can be obtained. Specimen Requirement: 1mL body fluid in a sterile container; Minimum: 1mL; Indicate body fluid type/source. Centrifuge to remove any cellular material; Frozen. Days Reported: 2-3 days CPT: 83930x1 4/7/16 Oxcarbazepine OXCARB Years: >40 ug/ml Porphobilinogen Screen Raji Cell Immune Complex Assay UPBG Ambient: Stable protected and unprotected from light for 24 hours Refrigerated: 1 week Frozen: 1 month RAJI Specimen Requirement: 1mL serum from a serum separator tube; Allow complete clotting of red blood cells (up to 1 hour), then separate serum from cells within 30 minutes and freeze immediately; Frozen. *OR* 3mL serum from a red top tube; Allow complete clotting of red blood cells (up to 1 hour), then separate serum from cells within 30 minutes and freeze immediately. 2/9/16 2/16/16 Sulfonylurea Hypoglycemia Panel, Quantitative, Urine USULFO Test Name: Previously Sulfonylurea Hypoglycemics, Urine 2/16/16 Uric Acid, Body Fluid FLURIC Specimen Requirement: 1mL drain in a clean container; Minimum: 0.2 ml; Indicate source. Centrifuge to remove cellular material. *OR* 1mL peritoneal fluid in a clean container; Minimum: 0.2mL; Centrifuge to remove cellular material; Refrigerated *OR* 1mL pleural fluid in a clean container; Minimum: 0.2mL; Centrifuge to remove cellular material; Refrigerated *OR* 1mL synovial fluid in a clean container; Minimum 0.2mL; Centrifuge to remove cellular material; Refrigerated Refer to 2/16/ Euclid Avenue Cleveland, Ohio clevelandcliniclabs.com 5

6 West Nile Virus Antibody Panel CSF West Nile Virus Antibody Panel Serum CNILE Clinical Information: This test is intended to be used as a semiquantitative means of detecting West Nile virus-specific IgG and IgM in CSF specimens in which there is a clinical suspicion of West Nile virus infection. This test should not be used solely for quantitative purposes, nor should the results be used without correlation to clinical history or other data. Because other members of the Flaviviridae family, such as St. Louis encephalitis virus, show extensive cross-reactivity with West Nile virus, serologic testing specific for these species should be considered. The detection of antibodies to West Nile virus in cerebrospinal fluid may indicate central nervous system infection. However, consideration must be given to possible contamination by blood or transfer of serum antibodies across the blood brain barrier. Specimen Requirement: 2.0mL Cerebrospinal fluid (CSF) in sterile container; Minimum: 0.3mL; Refrigerated. Ambient: 8 Hours Refrigerated: 2 Weeks Frozen: 1 Year (Avoid repeated freeze/thaw cycles) West Nile Virus, IgG, CSF: 1.29 IV or less: Negative No significant level of West Nile virus IgG antibody detected IV: Equivocal Questionable presence of West Nile virus IgG antibody detected. Repeat testing in days may 1.50 IV or greater: Positive Presence of IgG antibody to West Nile virus detected, suggestive of current or past infection. West Nile Virus, IgM, CSF: 0.89 IV or less: Negative No significant level of West Nile virus IgM antibody detected IV: Equivocal Questionable presence of West Nile virus IgM antibody detected. Repeat testing in days may 1.11 IV or greater: Positive Presence of IgM antibody to West Nile virus detected, suggestive of current or recent infection. Days Performed: Sunday, Tuesday, Friday Reported: 2-7 Days NILE Special Information: Parallel testing is preferred and convalescent specimens must be received within 30 days from receipt of the acute specimens. Mark specimen plainly as acute or convalescent. Clinical Information: Detect presence of IgG and IgM antibodies in individuals with a clinical suspicion of West Nile Virus. This test is intended to be used as a semiquantitative means of detecting West Nile virus-specific IgG and IgM in serum specimens in which there is a clinical suspicion of West Nile virus infection. This test should not be used solely for quantitative purposes, nor should the results be used without correlation to clinical history or other data. Because other members of the Flaviviridae family, such as St. Louis encephalitis virus, show extensive cross-reactivity with West Nile virus, serologic testing specific for these species should be considered. Seroconversion between acute and convalescent sera is considered strong evidence of current or recent infection. The best evidence for infection is a significant change on two appropriately timed specimens, where both tests are done in the same laboratory at the same time. Specimen Requirement: 1mL serum from an SST tube; Minimum: 0.15mL; Refrigerated. (continued on page 7) 9500 Euclid Avenue Cleveland, Ohio clevelandcliniclabs.com 6

7 West Nile Virus Antibody Panel Serum (continued from page 6) Ambient: 48 hours Refrigerated: 2 weeks Frozen: 1 year (avoid repeated freeze/thaw cycles) West Nile Virus, IgG, Serum: 1.29 IV or less: Negative No significant level of West Nile virus IgG antibody detected IV: Equivocal Questionable presence of West Nile virus IgG antibody detected. Repeat testing in days may 1.50 IV or greater: Positive Presence of IgG antibody to West Nile virus detected, suggestive of current or past infection. West Nile Virus, IgM, Serum: 0.89 IV or less: Negative No significant level of West Nile virus IgM antibody detected IV: Equivocal Questionable presence of West Nile virus IgM antibody detected. Repeat testing in days may 1.11 IV or greater: Positive Presence of IgM antibody to West Nile virus detected, suggestive of current or recent infection. Days Performed: Sunday, Tuesday, Friday Reported: 2-7 Days West Nile Virus IgG, CSF CWESTG Clinical Information: This test is intended to be used as a semiquantitative means of detecting West Nile virus-specific IgG in CSF specimens in which there is a clinical suspicion of West Nile virus infection. This test should not be used solely for quantitative purposes, nor should the results be used without correlation to clinical history or other data. Because other members of the Flaviviridae family, such as St. Louis encephalitis virus, show extensive cross-reactivity with West Nile virus, serologic testing specific for these species should be considered. The detection of antibodies to West Nile virus in cerebrospinal fluid may indicate central nervous system infection. However, consideration must be given to possible contamination by blood or transfer of serum antibodies across the blood-brain barrier. Specimen Requirement: 2mL Cerebrospinal fluid (CSF) in a sterile container; Minimum: 0.15mL; Refrigerated. Ambient: 8 Hours Refrigerated: 2 Weeks Frozen: 1 Year (avoid repeated freeze/thaw cycles) 1.29 IV or less: Negative - No significant level of West Nile virus IgG antibody detected IV: Equivocal - Questionable presence of West Nile virus IgG antibody detected. Repeat testing in days may 1.50 IV or greater: Positive - Presence of IgG antibody to West Nile virus detected, suggestive of current or past infection. Days Performed: Sunday, Tuesday, Friday Reported: 2-7 days 9500 Euclid Avenue Cleveland, Ohio clevelandcliniclabs.com 7

8 West Nile Virus IgG, Serum West Nile Virus IgM, CSF WESTG Special Information: Parallel testing is preferred and convalescent specimens must be received within 30 days from receipt of the acute specimens. Mark specimen plainly as "acute" or "convalescent". Clinical Information: This test is intended to be used as a semiquantitative means of detecting West Nile virus-specific IgG in serum specimens in which there is a clinical suspicion of West Nile virus infection. This test should not be used solely for quantitative purposes, nor should the results be used without correlation to clinical history or other data. Because other members of the Flaviviridae family, such as St. Louis encephalitis virus, show extensive cross-reactivity with West Nile virus, serologic testing specfic for these species should be considered. Seroconversion between acute and convalescent sera is considered strong evidence of current or recent infection. The best evidence for infection is a significant change on two appropriately timed specimens, where both tests are done in the same laboratory at the same time. Specimen Requirement: 1mL serum from an SST tube; Minimum: 0.15mL; Separate serum from cells ASAP or within 2 hours of collection; Refrigerated. Ambient: 48 hours Refrigerated: 2 weeks Frozen: 1 year (avoid repeated freeze/thaw cycles) 1.29 IV or less: Negative - No significant level of West Nile virus IgG antibody detected IV: Equivocal - Questionable presence of West Nile virus IgG antibody detected. Repeat testing in days may 1.50 IV or greater: Positive - Presence of IgG antibody to West Nile virus detected, suggestive of current or past infection. Days performed: Sunday, Tuesday, Friday Day reported: 2-5 days CWESTM Clinical Information: This test is intended to be used as a semiquantitative means of detecting West Nile virus-specific IgM in CSF specimens in which there is a clinical suspicion of West Nile virus infection. This test should not be used solely for quantitative purposes, nor should the results be used without correlation to clinical history or other data. Because other members of the Flaviviridae family, such as St. Louis encephalitis virus, show extensive cross-reactivity with West Nile virus, serologic testing specific for these species should be considered. The detection of antibodies to West Nile virus in cerebrospinal fluid may indicate central nervous system infection. However, consideration must be given to possible contamination by blood or transfer of serum antibodies across the blood-brain barrier. Specimen Requirement: 2mL Cerebrospinal fluid (CSF) in a sterile container; Minimum: 0.15mL; Refrigerated. Ambient: 8 hours Refigerated: 2 weeks Frozen: 1 year (avoid repeated freeze/thaw cycles) (continued on page 9) 9500 Euclid Avenue Cleveland, Ohio clevelandcliniclabs.com 8

9 West Nile Virus IgM, CSF (continued from page 8) West Nile Virus IgM, Serum 0.89 IV or less: Negative - No significant level of West Nile virus IgM antibody detected IV: Equivocal - Questionable presence of West Nile virus IgM antibody detected. Repeat testing in days may 1.11 IV or greater: Positive - Presence of IgM antibody to West Nile virus detected, suggestive of current or recent infection. Days performed: Sunday, Tuesday, Friday Days reported: 2-7 days WESTM Special Information: Parallel testing is preferred and convalescent specimens must be received within 30 days from receipt of the acute specimens. Mark specimens plainly as "acute" or "convalescent". Clinical Information: This test is intended to be used as a semiquantitative means of detecting West Nile virus-specific IgM in serum specimens in which there is a clinical suspicion of West Nile virus infection. This test should not be used solely for quantitative purposes, nor should the results be used without correlation to clinical history or other data. Because other members of the Flaviviridae family, such as St. Louis encephalitis virus, show extensive cross-reactivity with West Nile virus, serologic testing specific for these species should be considered. Seroconversion between acute and convalescent sera is considered strong evidence of current or recent infection. The best evidence for infection is a significant change on two appropriately timed specimens, where both tests are done in the same laboratory at the same time. Specimen Requirement: 1mL serum from an SST tube; Minimum: 0.15mL; Separate serum from cells ASAP or within 2 hours of collection; Refrigerated. Ambient: 48 hours Refrigerated: 2 weeks Frozen: 1 year (avoid repeated freeze/thaw cycles) 0.89 IV or less: Negative - No significant level of West Nile virus IgM antibody detected IV: Equivocal - Questionable presence of West Nile virus IgM antibody detected. Repeat testing in days may 1.11 IV or greater: Positive - Presence of IgM antibody to West Nile virus detected, suggestive of current or recent infection. Days performed: Sunday, Tuesday, Friday Days reported: 2-7 days 9500 Euclid Avenue Cleveland, Ohio clevelandcliniclabs.com 9

10 New Tests Test Name Order Code Billing Code Test Information Effective Date Bacterial Vaginosis Scored Gram Stain & Candida Smear BVCNSM Special Information: This test is constructed for the diagnosis of bacterial vaginosis (BV) and confirmation of the presence of yeasts, primarily Candida species, in women clinically suspected to have vulvovaginal candidiasis. If it is unclear that the patient has bacterial vaginosis, candidiasis or Trichomonas, then the recommended test is the Affirm (VAGDNA). This test is a probe test intended for use in patients with clinical signs and symptoms of vaginitis. The test detects Candida species, Trichomonas vaginalis and Gardnerella vaginalis nucleic acid in vaginal fluid specimens. Clinical criteria for the diagnosis of bacterial vaginosis (BV) include 1) thin, homogeneous vaginal discharge, 2) clue cells (vaginal squamous epithelial cells coated with bacteria that mask the cell border), 3) increased vaginal ph (>4.5), and 4) fishy odor of vaginal excretions enhanced by adding KOH. Women with BV may report no signs or symptoms. BV is not fully understood, but the condition is associated with a reduction in normal Lactobacillus flora and an increase in other bacteria including Gardnerella vaginalis, Mobiluncus and Bacteroides. BV has been associated with increased susceptibility to sexually transmitted diseases (HIV, HSV, gonorrhea, chlamydia) and obstetric complications (miscarriage, preterm birth, postpartum endometritis). Clinical Information: Determination of a score for the relative amounts of microbial morphologies observed in a Gram stain of vaginal fluid is the definitive method for diagnosing bacterial vaginosis. A predominance of medium to large gram positive bacilli is suggestive of lactobacilli (score 0-3) is consistent with normal vaginal flora. A predominance of gram negative or gram variable rods is suggestive of Gardnerella vaginalis, Mobiluncus and Bacteriodes sp (score 7-10) is consistent with bacterial vaginosis. An intermediate score (4-6) suggests a transition from normal vaginal flora. Additionally this method is used for the confirmation of vulvovaginal candidiasis. Exudative material on a swab should be submitted for microscopic examination to detect the presence of yeasts. Specimen Requirement: Unspecified vaginal swab; Ambient Ambient: 1 week Refrigerated: 1 week Frozen: Unacceptable Methodology: Gram Stain Days Performed: Sunday-Saturday Reported: 1 day CPT: 87205x1 Price: $ /18/16 BRAF Gene Analysis BRAFGN This test was previously documented in the 2016 January Technical Update. CPT: 80210, G0452 Price: Test will be Client Bill Only 3/13/ Euclid Avenue Cleveland, Ohio clevelandcliniclabs.com 10

11 New Tests (Cont.) Test Name Order Code Billing Code Test Information Effective Date HIV-1 Qualitative Test by PCR HIV1QL Clinical Information: The HIV-1 qualitative RT-PCR assay (HIV1QL) is most useful for the testing of neonates wherein immunoglobin from the mother interferes with serological testing. It is also useful in the earliest phases of HIV infection (i.e. the window period) and for patients with equivocal serologic studies. This assay is an advance over the previous version, which detected only integrated HIV DNA. The current assay detects both integrated viral DNA, as well as viral RNA, the latter of which may be present in higher copy numbers. Specimen Requirement: 4mL whole blood from EDTA (Lavender) tube; Minimum: 2mL; Whole blood must be transported at 2-25 C within 24 hours of collection. Do not freeze specimen. Frozen specimens will be rejected; Ambient Ambient: Whole blood must be transported at 2-25 C within 24 hours of collection Refrigerated: 5 days Frozen: Unacceptable Methodology: Polymerase Chain Reaction (PCR) Days Performed: Twice a week Reported: 5-7 days CPT: 87535x1 Price: $ /1/16 KIT Gene Analysis KITGN This test was previously documented in the 2016 January Technical Update. CPT: 81272, 81273, G0452 Price: Test will be Client Bill Only KRAS Gene Analysis KRASGN This test was previously documented in the 2016 January Technical Update. CPT: 81275,81276, G0452 Price:Test will be Client Bill Only 3/10/16 3/10/16 Fee Increases Test Name Order Code Billing Code List Fee CPT Code Effective Date Osmolality, Body Fluid FLOSM $94.00 (nondiscountable) /7/16 Discontinued Tests Test Name Order Code Billing Code Test Information Effective Date Chloramphenicol CLORAM Test discontinued. 4/4/ Euclid Avenue Cleveland, Ohio clevelandcliniclabs.com 11