Table of Contents. May 2013

Transcription

1 May 2013 Table of Contents Revision Message! Please note: 3/20/2013 communication revision for and 91451, Synthetic Cannabinoid Panels - line added. Please note: 3/20/2013 communication revision for Synthetic Cannabinoid Metabolites Screen - Basic, Urine - effective date change to 4/15/2013. Please note: 3/20/2013 communication revision for 7079 Lupus Anticoagulant Evaluation with Reflex - CPU mapping added and additional information added for clarification NEW TESTS Please Note: Not all test codes assigned to each assay are listed in the table of contents. Please refer to the complete listing on the page numbers indicated. Test Code Test Name Effective Date Page # FISH, Multiple Myeloma, 1q21 3/18/ FISH, Multiple Myeloma, IGH/MAFB, t(14;20) 3/18/ FISH, Myeloid Neoplasms, MECOM (EVI1), 3q26.2 3/18/ Sensory Motor Neuropathy Complete Antibody Panel 5/6/ Sensory Neuropathy Complete Antibody Panel 5/6/ SHOX (GHD) DNA Sequencing and Deletion 5/6/ Alpha-Fetoprotein and Acetylcholinesterase, Amniotic Fluid with Reflex to Fetal Hemoglobin Chlamydia/N. gonorrhoeae and T. vaginalis RNA, Qualitative TMA, Pap Vial 5/13/ /13/ Synthetic Cannabinoid Panel 1, Urine 5/13/ Synthetic Cannabinoid Panel 2, Urine 5/13/ DLO Page 1 of 30 May 2013

2 TEST CHANGES Please Note: Not all test codes assigned to each assay are listed in the table of contents. Please refer to the complete listing on the page numbers indicated. Test Code Former Test Code Test Name Effective Date Page # HE4, Ovarian Cancer Monitoring 5/6/ Lupus Anticoagulant Evaluation with Reflex 5/6/ Alkaline Phosphatase Isoenzymes 5/13/ Delta-Aminolevulinic Acid, 24 Hr Urine 5/13/ Delta-Aminolevulinic Acid, Random Urine 5/13/ HPV (Human Papillomavirus) Genotypes 16 and 18 5/13/ DISCONTINUED TESTS Please Note: Not all test codes assigned to each assay are listed in the table of contents. Please refer to the complete listing on the page numbers indicated. Test Code Test Name Effective Date Page # IgA Fibronectin Aggregates and Serum IgA Panel 5/6/ IgA Fibronectin Aggregates, ELISA 5/6/ Synthetic Cannabinoid Metabolites Screen, Urine 5/13/ Lyme Disease Antibodies (IgG,IgM), IBL (SF) 5/20/ SEND OUTS Please Note: Not all test codes assigned to each assay are listed in the table of contents. Please refer to the complete listing on the page numbers indicated. Test Code Former Test Code Test Name Effective Date Page # 3493 Bumetanide 5/6/ Chlorothiazide (U) 5/6/ Chlorthalidone, Urine 5/6/ Diuretics Panel, Urine 5/6/ DLO Page 2 of 30 May 2013

3 Summary of Changes Test Name 21 IgA Fibronectin Aggregates and Serum IgA Panel 21 IgA Fibronectin Aggregates, ELISA 21 Synthetic Cannabinoid Metabolites Screen, Urine 21 Lyme Disease Antibodies (IgG,IgM), IBL (SF) 15 HE4, Ovarian Cancer Monitoring 15 Lupus Anticoagulant Evaluation with Reflex 16 Alkaline Phosphatase Isoenzymes 17 Delta-Aminolevulinic Acid, 24 Hr Urine 17 Delta-Aminolevulinic Acid, Random Urine 18 HPV (Human Papillomavirus) Genotypes 16 and 18 Test Code(s) 18 Bumetanide Chlorothiazide (U) Chlorthalidone, Urine Diuretics Panel, Urine Diuretics Screen, Urine X X X X X X X X X X X 7079 X X 231 X 219 X X 6301 X X 20 Diuretics Confirmation, Urine %91596 DLO Page 3 of 30 May 2013

4 New Test Offerings The following tests will be available through DLO on the dates indicated below. Clinical Significance Effective Date 3/18/2013 Test Code CPT Codes (x2), FISH, Multiple Myeloma, 1q21 Chromosomal abnormalities are detected in 80-85% of myeloma patients. One or more extra copies of 1q21 has been associated with poor prognosis in patients with newly diagnosed myeloma, whether as a sole abnormality or in combination with other nonrandom abnormalities. Prognostic factors such as this are helpful to clinicians in determining therapy and predicting long-term survival. Preferred: 3 ml (1 ml minimum) bone marrow collected in culture transport medium Instructions Acceptable: 1-3 ml bone marrow collected in a sodium heparin (green, tan or royal blue-top) tube 3-5 ml whole blood with greater than 20% plasma cells collected in a sodium heparin (green, tan or royal blue-top) tube In rare cases of plasma cell leukemia, peripheral blood, typically with greater than 20% plasma cells, is an acceptable specimen. For blood sample, please submit 3-5 ml in sodium heparin (green, royal blue or tan-top) tube. Clinical history and reason for referral are required with test order. Prior therapy and transplant history should be provided with test order. Specimen viability decreases in transit. Send specimen to testing lab for viability determination. **DO NOT REJECT** Reference Range Room temperature Room temperature and Refrigerated: See Instructions Frozen: Unacceptable Accompanies report Fluorescence in situ hybridization (FISH) Quest Diagnostics Nichols Institute, San Juan Capistrano Result Code: Type: Result Name: FISH, Multiple Myeloma, 1Q (NR) AOE Specimen Type/Source/Vol (NR) AOE Clinical Indication: (NR) AOE Referring Physician: (NR) AOE Referring Physician Phone (NR) AOE Client/Phone # DLO Page 4 of 30 May 2013

5 (NR) AOE Client Accession # (NR) AOE Patient ID: Clinical Significance Effective Date 3/18/2013 Test Code CPT Codes (x2), FISH, Multiple Myeloma, IGH/MAFB, t(14;20) The IGH-MAFB probe set is used to detect the t(14;20)(q32;q12) in patients with high-risk plasma cell myeloma (PCM). This translocation is strongly associated with del(13q), hypodiploidy, and gain of 1q. However, patients with t(14;20) and monoclonal gammopathy, MGUS, or smoldering PCM, may have stable disease for years before progressing. Preferred: 3 ml (1 ml minimum) bone marrow collected in culture transport medium Instructions Reference Range Acceptable: 1-3 ml bone marrow collected in a sodium heparin (green, tan or royal blue-top) tube 3-5 ml whole blood collected in a sodium heparin (green, tan or royal blue-top) tube Clinical history and reason for referral are required with test order. Prior therapy and transplant history should be provided with test order. Specimen viability decreases in transit. Send specimen to testing lab for viability determination. **DO NOT REJECT** Room temperature Room temperature and Refrigerated: See Instructions Frozen: Unacceptable Accompanies report Fluorescence in situ hybridization (FISH) Quest Diagnostics Nichols Institute, San Juan Capistrano Result Code: Type: Result Name: FISH, Multiple Myeloma, IGH/MAFB, T(14 20) (NR) AOE Specimen Type/Source/Vol (NR) AOE Clinical Indication: (NR) AOE Referring Physician: (NR) AOE Referring Physician Phone (NR) AOE Client/Phone # (NR) AOE Client Accession # (NR) AOE Patient ID: DLO Page 5 of 30 May 2013

6 Clinical Significance Effective Date 3/18/2013 Test Code CPT Codes (x3), FISH, Myeloid Neoplasms, MECOM (EVI1), 3q26.2 Disruption of the human entropic virus integration site (EVI1 or MECOM) gene located at chromosome band 3q26.2 is associated with myeloid neoplasms and is indicative of a poor prognosis. EVI1 rearrangements are especially frequent in myeloid blast crisis that evolves through tyrosine kinase inhibitors. It has been associated with dysplasia of megakaryocytes and alters differentiation of other myeloid cells. Associated rearrangements include inv(3)(q21q26), t(3;3)(q21;q26), t(3;21)(q26;q22) and t(3;12)(q26;p13). Preferred: 3 ml (1 ml minimum) bone marrow collected in culture transport medium Instructions Acceptable: 1-3 ml bone marrow collected in a sodium heparin (green-top, tan-top or royal blue-top) tube 3-5 ml whole blood with greater than 20% plasma cells collected in a sodium heparin (green-top, tan-top or royal blue-top) tube In rare cases of plasma cell leukemia, peripheral blood, typically with greater than 20% plasma cells, is an acceptable specimen. For blood sample, please submit 3-5 ml in sodium heparin (green, tan or royal blue-top) tube. Clinical history and reason for referral are required with test order. Prior therapy and transplant history should be provided with test order. Specimen viability decreases in transit. Send specimen to testing lab for viability determination. **DO NOT REJECT** Reference Range Room temperature Room temperature and Refrigerated: See instructions Frozen: Unacceptable Accompanies report Fluorescence in situ hybridization (FISH) Quest Diagnostics Nichols Institute, San Juan Capistrano Result Code: Type: Result Name: FISH, Myeloid Neoplasms, MECOM (EVI1), 3Q (NR) AOE Specimen Type/Source/Vol (NR) AOE Clinical Indication: (NR) AOE Referring Physician: DLO Page 6 of 30 May 2013

7 (NR) AOE (NR) AOE (NR) AOE (NR) AOE Referring Physician Phone Client/Phone #: Client Accession # Patient ID: Clinical Significance Test Code CPT Codes Reject Criteria Instructions Reference Range Sensory Motor Neuropathy Complete Antibody Panel Sensory-motor neuropathies may occur by various mechanisms including autoantibodies to neuronal structures, antibody cross-reactivity or local immune complex deposition as seen in autoimmune disease with primarily non-neuronal targets, and systemic immune complex deposition disease. Motor-sensory neuropathy may be associated with monoclonal gammopathy , 86255, 82595, 86334, (x3), 86431, (x2), 86038, (x3), 83516, (x9) 19.2 ml (8.2 ml minimum) serum collected in a red-top tube (no gel) Serum separator tube for Cryoglobulin; gross hemolysis; gross lipemia; icteric samples; received frozen; microbially contaminated serum; specimen containing visible particles; heat inactivated samples should not be used. See individual assays. Overnight fasting is preferred. Avoid hemolysis. Avoid lipemia. Avoid freezing and thawing Refrigerated Room temperature: 24 hours Refrigerated: 72 hours Frozen: Unacceptable See individual assays See individual assays Assay Category ASR Class 1 Quest Diagnostics Nichols Institute, San Juan Capistrano Note: For mapping, please access NSDB If the MAG Ab (IgM), WB result is positive then both MAG-SGPG Ab (IgM), EIA and MAG Ab (IgM), EIA will be performed at an additional charge (CPT code(s): (x2)) If the Hu Ab, IFA, Serum result is positive, then Hu Ab, Western Blot, Serum will be performed at an additional charge (CPT code(s): 84181) If the Hu Ab, IFA, Western Blot, Serum result is positive, then Hu Ab, Titer, Serum will be performed at an additional charge (CPT code(s): DLO Page 7 of 30 May 2013

8 86256) If the Cryoglobulin Screen is positive, then Cryoglobulin Reflex will be performed at an additional charge (CPT code(s): 86334, 86329) If the ANA Screen, IFA result is positive, then ANA IFA pattern and titer will be performed at an additional charge (CPT code(s): 86039) If the ANCA Screen, IFA result is positive, then P-ANCA, C-ANCA and Atypical P-ANCA IFA pattern and titer will be performed at an additional charge (CPT code(s): (x3)) If the TTG (IgA) result is positive (>8), then Endomysial Ab screen will be performed at an additional charge (CPT code(s): 86255) If Endomysial Screen result is positive, then Endomysial Ab Titer will be performed at an additional charge (CPT code(s): 86256) If IgA, Serum result is abnormal, then TTG (IgG) will be performed at an additional charge (CPT code(s): 83516) Test Code CPT Codes Reject Criteria Instructions Reference Range Sensory Neuropathy Complete Antibody Panel 84181, 86255, 82595, 86334, (x3), 86431, (x2), 86038, (x3), 83516, (x3) 18.2 ml (7.2 ml minimum) serum collected in a red-top tube (no gel) Serum separator tube for Cryoglobulin; gross hemolysis; gross lipemia; icteric samples; received frozen; microbially contaminated serum; specimen containing visible particles; heat inactivated samples should not be used See individual assays. Overnight fasting is preferred. Avoid hemolysis. Avoid lipemia. Avoid freezing and thawing. Refrigerated Room temperature: 24 hours Refrigerated: 72 hours Frozen: Unacceptable See individual assays See individual assays Assay Category ASR Class 1 Quest Diagnostics Nichols Institute, San Juan Capistrano Note: For mapping, please access NSDB If the MAG Ab (IgM), WB result is positive then both MAG-SGPG Ab (IgM), EIA and MAG Ab (IgM), EIA will be performed at an additional charge (CPT code(s): (x2)) If the Hu Ab, IFA, Serum result is positive, then Hu Ab, Western Blot, Serum will be performed at an additional charge (CPT code(s): DLO Page 8 of 30 May 2013

9 84181) If the Hu Ab, IFA, Western Blot, Serum result is positive, then Hu Ab, Titer, Serum will be performed at an additional charge (CPT code(s): 86256) If the Cryoglobulin Screen is positive, then Cryoglobulin Reflex will be performed at an additional charge (CPT code(s): 86334, 86329) If the ANA Screen, IFA result is positive, then ANA IFA pattern and titer will be performed at an additional charge (CPT code(s): 86039) If the ANCA Screen, IFA result is positive, then P-ANCA, C-ANCA and Atypical P-ANCA IFA pattern and titer will be performed at an additional charge (CPT code(s): (x3) If the TTG (IgA) result is positive (>8), then Endomysial Ab will be performed at an additional charge (CPT code(s): 86255) If Endomysial Screen result is positive, then Endomysial Ab Titer will be performed at an additional charge (CPT code(s): 86256) If IgA, Serum result is abnormal, then TTG (IgG) will be performed at an additional charge (CPT code(s):83516) Clinical Significance Test Code CPT Codes 81405, Reject Criteria Instructions SHOX (GHD) DNA Sequencing and Deletion Detects deletions and sequence variations in the SHOX gene 10 ml whole blood collected in an EDTA (lavender-top) tube 2 ml pediatric specimen Received frozen Please label each specimen tube with two forms of patient identification. These forms of identification must also appear on the requisition form. Sample must be shipped same day and arrive at Athena on a weekday. Specimens should not be collected or sent on Friday or Saturday. Note: This test requires inform consent Reference Range Assay Category Refrigerated Room temperature: Unacceptable Refrigerated: 72 Hours Frozen: Unacceptable No deletions detected, no sequence variation detected Multiplex ligation-dependent probe amplification (MLPA), Polymerase chain reaction (PCR) and DNA sequencing ASR Class I Athena Diagnostics INC. DLO Page 9 of 30 May 2013

10 Result Code: Result Name: Interpretation Technical Results Methods Comments References Summary Interpretation Technical Results Methods Comments References Interpretation Technical Results Methods Comments References Alpha-Fetoprotein and Acetylcholinesterase, Amniotic Fluid with Reflex to Fetal Hemoglobin Clinical Significance Effective Date 5/13/2013 Test Code CPT Codes 82106, Instructions Alpha-fetoprotein (AFP) utility in the early detection of fetal open neural tube defects (NTD) has been widely confirmed. The severity of a neural tube defect can range from moderate, such as spina bifida, to severe and non-lifecompatible, such as anencephaly. Acetylcholinesterase(AChE) is an enzyme that hydrolyzes the neurotransmitter acetylcholine. In a fetus with an open neural tube defect, AChE leaks directly into the amniotic fluid from fetal CSF, causing unexpectedly high levels of amniotic fluid AChE. However, a major cause of borderline amniotic fluid AFP elevations and/or false positive AChE results is contamination of the sample with fetal blood. Therefore, reflex testing for the presence of fetal hemoglobin (HbF) should be performed on samples with elevated AFP results, and in particular when acetylcholinesterase is weak positive or not detected at all. It is important to remember that many fetal anomalies, including neural tube defects and ventral wall defects, may also lead to fetal bleeding. 2.4 ml (1.2 ml minimum) amniotic fluid collected in a serum separator tube Avoid contaminating the fluid with blood. Gestational age (13-24 weeks) must be provided for interpretation of results. Indicate gestational age, collection date, clinical indications and the AFP and MoM results, if DLO Page 10 of 30 May 2013

11 available, on the test request form. Reference Range Always Message Room temperature Room temperature: 14 days Refrigerated: 21 days Frozen: 1 year Accompanies Report If you have questions concerning this report, please feel free to call our Prenatal Screening Program Center at , ext or AFP: Chemiluminescent, Radial Immunodiffusion, Gel Electrophoresis Quest Diagnostics Nichols Institute, San Juan Capistrano %232BRQEZ -Alpha-Fetoprotein, Amniotic Fluid Result Code: Type: Result Name: Alpha-Fetoprotein Multiple of the Median AOE LMP or LMP EDD AOE US Date or US EDD AOE Weeks of Gestation Calculated Gestational Age By LMP or US AOE Date of Draw %4929ARQEZ - Acetylcholinesterase Result Code: Result Name: Acetylcholinesterase This is a true reflex test; see below for mapping %36208ARQEZ - Fetal Hemoglobin, Amniotic Fluid Result Code: Result Name: Fetal Hemoglobin, Amniotic Fluid If Alpha-Fetoprotein, Amniotic fluid is Positive, Fetal Hemoglobin, Amniotic Fluid is performed at an additional charge (CPT code 83033) Clinical Significance Chlamydia/N. gonorrhoeae and T. vaginalis RNA, Qualitative TMA, Pap Vial Effective Date 5/13/2013 Test Code CPT Codes 87491, 87591, Specimen Requirements Diagnosis of the three most common sexually transmitted infections. 0.5 ml SurePath preservative fluid collected in Aptima Vaginal Collection Kit (orange label) DLO Page 11 of 30 May 2013

12 Instructions SurePath fluid must be transferred to APTIMA STM within 4 days of collection. Transfer 0.5 ml of SurePath preservative fluid into APTIMA Vaginal Collection Tube (orange label) or APTIMA Specimen Transfer tube (green label). Ship to lab. Room temperature Room temperature and Refrigerated: 14 days Frozen: Not Established C. trachomatis RNA, TMA Not detected Reference Range N. gonorrhoeae RNA, TMA Not detected T. vaginalis RNA, TMA Not detected % Chlamydia trachomatis/neisseria gonorrhoeae RNA, TMA, Pap Vial This test was performed using the APTIMA COMBO2 Assay (GEN- PROBE). Always Message The performance characteristics of this assay when used to test SurePath specimens have been determined by Quest Diagnostics Nichols Institute, San Juan Capistrano. Performance characteristics refer to the analytical performance of the test. % Trichomonas vaginalis RNA, Qualitative TMA, Pap Vial This test was performed using the APTIMA Trichomonas vaginalis Assay (Gen-Probe). The performance characteristics of this assay when used to test SurePath specimens have been determined by Quest Diagnostics Nichols Institute, San Juan Capistrano. Performance characteristics refer to the analytical performance of the test. Transcription-Mediated Amplification (TMA) Quest Diagnostics Nichols Institute, San Juan Capistrano SJC CPU Mapping %91632RQEZ - Chlamydia trachomatis/n. gonorrhoeae RNA, TMA Result Code: Result Name: C. trachomatis RNA, TMA N. gonorrhoeae RNA, TMA %91639RQEZ - Trichomonas vaginalis RNA, Qualitative TMA Result Code: Result Name: T. vaginalis RNA, QL TMA DLO Page 12 of 30 May 2013

13 Clinical Significance Effective Date 5/13/2013 Test Code CPT Codes Reference Range Synthetic Cannabinoid Panel 1, Urine Synthetic Cannabinoids refer to a wide variety of herbal mixtures that produce experiences similar to marijuana (cannabis) that are marketed as legal alternatives to that drug. Sold under names, including "K2," "fake weed," "Yucatan Fire," "Skunk," "Moon Rocks," and "Spice," they are labeled "not for human consumption". Synthetic Cannabinoids are psychoactive designer drugs made with dried, shredded plant materials and chemical additives that induce psychoactive effects. 5 ml (1 ml minimum) urine collected in a plastic, leakproof container Room temperature Room temperature, Refrigerated and Frozen: 7 days Negative Liquid Chromatography, Tandem Mass Spectrometry Quest Diagnostics Nichols Institute, Chantilly Result Code: Result Name: JWH 018 N (4 hydroxypentyl) metabolite JWH 018 N (5 hydroxypentyl) metabolite JWH 073 N (3 hydroxybutyl) metabolite JWH 073 N (4 hydroxybutyl) metabolite Includes: JWH-018 N-(4-hydroxypentyl) metabolite JWH-018 N-(5-hydroxypentyl) metabolite JWH-073 N-(3-hydroxybutyl) metabolite JWH-073 N-(4-hydroxybutyl) metabolite Synthetic Cannabinoid Panel 2, Urine Effective Date 5/13/2013 Test Code CPT Codes ml (1 ml minimum) urine collected in a plastic, leakproof container Room temperature Room temperature, Refrigerated and Frozen: 7 days Reference Range Negative Liquid Chromatography, Tandem Mass Spectrometry Quest Diagnostics Nichols Institute, Chantilly Result Code: Result Name: DLO Page 13 of 30 May 2013

14 JWH 018 N (4 Hydroxypentyl) Metabolite JWH 018 N (5 Hydroxypentyl) Metabolite JWH 073 N (3 Hydroxybutyl) Metabolite JWH 073 N (4 Hydroxybutyl) Metabolite AM 2201 N (4 Hydroxypentyl) Metabolite JWH 019 N (5 Hydroxyhexyl) Metabolite JWH 250 N (4 Hydroxypentyl) Metabolite Includes: AM-2201 N-(4-hydroxypentyl) metabolite JWH-018 N-(4-hydroxypentyl) metabolite JWH-018 N-(5-hydroxypentyl) metabolite JWH-019 N-(5-hydroxyhexyl) metabolite JWH-073 N-(3-hydroxybutyl) metabolite JWH-073 N-(4-hydroxybutyl) metabolite JWH-250 N-(4-hydroxypentyl) metabolite DLO Page 14 of 30 May 2013

15 Test Changes The following test changes will be effective on the dates indicated below. Please note that only the information that is changing appears in this update. Former test names and test codes have been italicized. Test Code Reject Criteria Instructions Reference Range HE4, Ovarian Cancer Monitoring 0.5 ml (0.3 ml minimum) serum Gross hemolysis; lipemia; icteric specimens; presence of fibrin, red blood cells, or other particulate matter; obvious microbial contamination Sample collected in a red-top tube must be allowed to clot for at least 30 minutes but no longer than 1 hour Frozen Room temperature: 48 hours Refrigerated: 72 hours Frozen: 28 days Female Premenopausal < or = 70 pmol/l Female Postmenopausal < or = 140 pmol/l Chemiluminescent Microparticle Immunoassay (CMIA) This test previously performed at Quest Diagnostics Nichols Institute Valencia, will now be performed at Quest Diagnostics Nichols Institute, San Juan Capistrano. Lupus Anticoagulant Evaluation with Reflex Test Code 7079 Reject Criteria Received thawed (CHY); Hemolysis Quest Diagnostics Nichols Institute, San Juan Capistrano CPU Mapping SJC: %7079ARQEZ - Lupus Anticoagulant Result Code: Result Name: Lupus Anticoagulant PTT LA Screen %7079CRQEZ - drvvt Screen Result Code: Result Name: drvvt Screen This is a true reflex test; see below for mapping %36573RQEZ - Hexagonal Phase Confirm DLO Page 15 of 30 May 2013

16 Result Code: Result Name: Hexagonal Phase Confirm %15111RQEZ - DRVVT Confirm Result Code: Result Name: drvvt Confirm %B19791RQEZ - drvvt 1:1 Mix Result Code: Result Name: drvvt 1:1 Mix drvvt MIX Interpretation %883ARQEZ - Thrombin Clotting Time Result Code: Result Name: Thrombin Clotting Time Addition of reflex criteria If the PTT-LA test is prolonged (>40 seconds), the Hexagonal Phase Confirm is performed at an additional charge. (CPT: 85598) If the Hexagonal Phase Confirm is positive or weakly positive a Thrombin Clotting Time will be performed at an additional charge. (CPT: 85670) (Please refer to the 883 and %883 (In-house) - Thrombin Clotting Time article below) If the drvvt screen is prolonged (>45 seconds), the drvvt Confirm is performed at an additional charge. (CPT: 85597) If the drvvt Confirm is positive, a drvvt 1:1 Mix will be performed at an additional charge. (CPT: 85613) Tests Affected Test Codes: Name: Antiphospholipid Syndrome Diagnostic Panel Lupus Anticoagulant & Antiphospholipid Confirmatory Panel (on Coumadin) w/o Consultation Alkaline Phosphatase Isoenzymes Effective Date 5/13/2013 Test Code 231 Quest Diagnostics Nichols Institute, San Juan Capistrano %234RQEZ - Alkaline Phosphatase Result Code: Result Name: Alkaline Phosphatase %91641RQEZ - Alkaline Phosphatase Isoenzymes Result Code: Result Name: DLO Page 16 of 30 May 2013

17 Intestine Isoenzyme Placental Isoenzyme Bone Isoenzyme Liver Isoenzyme Update report format Effective Date 5/13/2013 Test Code 219 Delta-Aminolevulinic Acid, 24 Hr Urine Preferred: 24-hour urine, no preservative Instructions Acceptable: Urine preserved with 25 ml 6N HCl or 10 ml concentrated glacial acetic acid, preservative added after collection, and catherized urine in a sterile, plastic, screw-cap container. Collect without preservative. Refrigerate during and after collection. Wrap container in aluminum foil to protect from light. Please specify on the request form and on the urine container the total 24-hour urine volume. This test previously performed at Quest Diagnostics Nichols Institute, San Juan Capistrano, will now be performed at Quest Diagnostics Nichols Institute, Chantilly. Effective Date 5/13/2013 Test Code 6301 Instructions Delta-Aminolevulinic Acid, Random Urine Wrap container in aluminum foil to protect from light. Do not use preservatives. Do not use first morning void, late evening specimen (after 8 p.m.), or specimen after excessive fluid intake. Keep refrigerated and transport refrigerated (cold packs). Acceptable: Urine preserved with 1 ml concentrated glacial acetic acid or 1 ml 6N HCl, protected from light, catherized urine in sterile, plastic, screw-cap container. This test previously performed at Quest Diagnostics Nichols Institute, San Juan Capistrano will now be performed at Quest Diagnostics Nichols Institute, Chantilly. DLO Page 17 of 30 May 2013

18 HPV (Human Papillomavirus) Genotypes 16 and 18 Effective Date 5/13/2013 Test Code Quest Diagnostics Nichols Institute, San Juan Capistrano Result Code: Result Name: HPV16 DNA, Invader(R) HPV18 DNA, Invader(R) Update report format. Test Send Outs (Referrals) Due to these assays being performed by outside vendors, we are unable to use our normal method of communication. Some of the changes listed in this document may be effective in less than 30 days. Please note the individual effective dates below, as these changes may require IMMEDIATE ACTION. Test Code 3493 Bumetanide The vendor is discontinuing this test code. No recommended alternative. Chlorothiazide (U) Test Code 6080 The vendor is discontinuing this test code: The recommended alternative is: Chlorothiazide Test Code 3193 Chlorthalidone, Urine The vendor is discontinuing this test code. The recommended alternatives are: Chlorthalidone, Blood Chlorthalidone DLO Page 18 of 30 May 2013

19 Test Code Diuretics Panel, Urine The vender is discontinuing this test code. The recommended alternatives are: Diuretics Screen, Urine Diuretics Confirmation, Urine Test Code Reject Criteria Units Of Measure Diuretics Screen, Urine 2 ml (0.8 ml minimum) urine collected in a plastic urine container Received room temperature Refrigerated Room temperature: Unacceptable Refrigerated: 14 days Frozen : 28 days ng/ml High Performance Liquid Chromatography/Tandem Mass Spectrometry Result Code: Result Name: Chlorothiazide Hydrochlorothiazide Acetazolamide Hydroflumethiazide Triamterene Chlorthalidone Furosemide Metolazone Indapamide Torsemide Bumetanide Canrenone DLO Page 19 of 30 May 2013

20 Test Code %91596 Reject Criteria Units Of Measure Diuretics Confirmation, Urine 1 ml (0.4 ml minimum) urine collected in a plastic urine container Received room temperature Refrigerated Room temperature: Unacceptable Refrigerated: 14 days Frozen: 28 days ng/ml High Performance Liquid Chromatography/Tandem Mass Spectrometry Result Code: Result Name: Chlorothiazide Hydrochlorothiazide Acetazolamide Hydroflumethiazide Triamterene Chlorthalidone Furosemide Metolazone Indapamide Torsemide Bumetanide Canrenone DLO Page 20 of 30 May 2013

21 Discontinued IgA Fibronectin Aggregates and Serum IgA Panel Test Code No recommended alternative. IgA Fibronectin Aggregates, ELISA Test Code No recommended alternative. Effective Date 5/13/2013 Test Code Synthetic Cannabinoid Metabolites Screen, Urine This test code is being discontinued. The recommended alternative is Synthetic Cannabinoid Panel 1, Urine, in the New Test Offerings Section. Please note: this code is contained in custom panels Lyme Disease Antibodies (IgG,IgM), IBL (SF) Effective Date 5/20/2013 Test Code No recommended alternative. DLO Page 21 of 30 May 2013