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Policy for Priority Result Reporting

Purpose/Introduction

The Quest Diagnostics Priority Result Reporting Policy describes the reporting of test results, as designated by the Chief Laboratory Officer and Best Practice Team Medical Advisors, which may require attention by the healthcare provider prior to regular delivery of results. The priority result reporting described in this policy is in addition to the regular reporting procedure for all test results (such as printed reports delivered by mail). The provider who requested the test is responsible for providing 24-hour reliable contact information for the purpose of priority reporting. The person notified should be the ordering provider or her/his authorized representative as permitted or required by state and federal law, and has the responsibility of interpreting the result in the context of the patient's clinical condition and to take immediate action, if needed. If the person notified is not qualified to make these decisions, he/she has the responsibility to communicate the information to a qualified person immediately.

Priority Level Definitions

Priority-1 test results include, but are not limited to, results considered "critical" according to the Clinical Laboratory Amendments of 1988 (CLIA; CFR 493.1109f) and the College of American Pathologists (CAP) Laboratory Accreditation Program and so designated by the Chief Laboratory Officer or designee. Because test results cannot be fully interpreted without knowledge of the patient's current clinical condition and treatment, we will use reasonable efforts to promptly communicate Priority-1 results at any hour of the day, 7 days/week so that the healthcare provider can determine the clinical implications and possible need for immediate attention. Priority-2 test results are those that may require attention prior to the receipt of routine laboratory reports. We will use reasonable efforts to promptly communicate these results the same day (up to 7pm) or the next morning (after 7am), 7 days/week. Tests marked Priority 2WD are called between 7 am and 7 pm weekdays. For facilities that are known to us as a nursing home or hospital, we will use reasonable efforts to promptly communicate these results at any hour of the day, 7 days/week. Priority-3 reporting applies only to customers whose sole means of obtaining Quest Diagnostics laboratory results is the printed report (i.e., receiving only mailed or courierdelivered reports) and to clients who have requested Priority-3 reporting in writing during the previous 12 months. These are test results that may require attention before receipt of the printed report and will be called during weekday working hours. The attached Priority Value Table will not be modified (changed, deleted from, or added to) without the signed written request of the client.

Quest Diagnostics Priority Result Reporting Policy (client synopsis) (Appendix 5)

Version 10.0 Revised 6/04/12

Quest Diagnostics National Priority Value Tables by Testing Department

Chemistry / Special Chemistry

Analyte

Ammonia [umol/L] Amylase [U/L] Bilirubin, total [mg/dL] Bilirubin, total [mg/dL] BUN[mg/dL] Calcium, Total [mg/dL] Calcium, Ionized [mg/dL] CK ­ MB

Priority 3 (called 7am ­ 7pm M ­ F)

(For clients without electronic reporting)

Priority 2 (called 7am ­ 7pm 7 days) Age

All

Priority 1 (called 24 hrs 7 days) Age

18 y

Age

Low

High

Low

High

300

Low

High

> 200 15.0

2y >2y All

12.1 ­ 14.9 > 20.0 100

2y

All All All > positive cutoff value (varies with assay) 1000 6000

6.0 3.2

13.0 > 6.9

CK [U/L] CK [U/L] Complement levels Creatinine [mg/dL] Galactose, urine [mg/dL] Galactose ­ 1 ­ Phosphate [mg/dL packed RBC] Glomerular Basement Membrane Antibody IgG [AI] (Bioplex assay) Glomerular Basement Membrane Antibody IgG [Units] (Inova assay, Nichols Valencia patients only) Glucose, serum [mg/dL] *Glucose results are flagged P1 ­ P2 regardless of ordered test (OGTT, random glucose, serum or plasma, etc.). When these results are called to the client, the report title of the test result should be made known to the client. Glucose, CSF, [mg/dL] Iron (serum) [mcg/dL] Lipase [U/L] 12 y 500 <2y None detected

18 y > 18 y

All 2y 2y

8.00 > 70 > 5.0 All All > 8.0 > 40

All

400-499

All

< 40

500

All All 180

<30

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Quest Diagnostics National Priority Value Tables by Testing Department

Chemistry / Special Chemistry

Analyte

Magnesium serum or plasma [mg/dL] Phosphate (as phosphorous) serum or plasma [mg/dL] Potassium serum or plasma [mmol/L] Sodium serum or plasma [mmol/L] Troponin (I or T) TSH [mIU/L] Uric Acid, [mg/dL] Viscosity (serum) [relative to water] 1y All 50.00 >14.0 All 3.0

Priority 3 (called 7am ­ 7pm M ­ F)

(For clients without electronic reporting)

Priority 2 (called 7am ­ 7pm 7 days) Age Low High

Priority 1 (called 24 hrs 7 days) Age

All All All All All

Age

Low

High

Low

0.7 1.0 2.7 120

High

6.1

6.2 160 Positive > cutoff value

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Quest Diagnostics National Priority Value Tables by Testing Department

Hematology / Coagulation / Urinalysis

Analyte

Blasts, absolute number [/uL] Cerebrospinal fluid (CSF)

Priority 3 (called 7am ­ 7pm M ­ F)

(For clients without electronic reporting)

Priority 2 (called 7am ­ 7pm 7 days)

Priority 1 (called 24 hrs 7 days)

Age

Low

High

Age

All

Low

High

Blasts >0 (new patient only)

Age

All All

Low

High

50,000 on any patient Any abnormal per local Med. Director

Coagulation Factors VIII & IX, Activity [%] Coagulation Factor XIII, Activity [%] Coagulation Factor VIII, IX and XI Inhibitor [Bethesda Unit] Cryoglobulin [%] Fibrinogen Clotting Activity, Clauss Method [mg/dL] Heparin, unfractionated [IU/mL] Heparin, low molecular weight [IU/mL] Heparin ­ Induced Platelet Antibody Serotonin Release Assay [%] Von Willebrand Factor Protease Cleaving Activity [%] Glucose (Urinalysis) Hemoglobin [g/dL] Hemoglobin [g/dL] Malaria parasites or other organisms (Babesia, Ehrlichia, Trypanosomes etc.) [also appears in Microbiology section] 16 y 3+ or higher

All All All All All All All All All All

<5 < 20 >2 >3 < 50 > 1.10 > 2.0 Positive 20 30

12 y > 12 y All

7.0 ­ 8.9 6.1 ­ 7.0 Positive for any blood parasites other than P falciparum < 1,000 > 30,000

12 y > 12 y All

< 7.0 6.0

22.5 22.5

Positive for verified P falcparum or unspeci-ated Plasmodium sp." that are possibly P. falciparum

WBC, absolute number [/uL] Neutrophils, absolute number [/uL] Band neutrophils [/uL] Partial Thromboplastin Time,(aPTT) [sec.] Platelet Count [/uL] Prothrombin Time-International Normalized Ratio (PT-INR) Reducing Substance (Urinalysis,Clinitest) All All All All 2y 20,000 ­ 50,000 > 10,000 60 ­ 89 1,000,000 ­ 1,999,999 4.0 ­ 4.9 Positive

All All

All All All

< 400 90 < 20,000 2,000,000 8.0

All

5.0 ­ 7.9

All

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Quest Diagnostics National Priority Value Tables by Testing Department

Microbiology / Serology

Analyte

Aspergillus (galactomannan) antigen, serum or bronchoalveolar lavage Bacillus anthracis, culture, nucleic acid, or antigen test Bacterial meningitis antigens, CSF Bordetella pertussis, culture, nucleic acid, or antigen Bordetella parapertussis, culture, nucleic acid, or antigen Brucella sp., culture, nucleic acid or antigen test Chlamydia trachomatis, culture, nucleic acid or antigen test Clostridium difficile toxin A, B, A+B or toxigenic culture, stool (Note: nontoxigenic strains should not be called) Corynebacterium diphtheriae, nasopharynx culture Cryptococcus antigen, serum or CSF Culture: blood, CSF, any tissue or sterile body fluid (excluding urine) Enterobacteriaceae isolates, Carbapenemase producing (Hodge test positive) E coli O157, culture, stool Francisella tularensis, culture, nucleic acid, or antigen test Gram or other stain of direct specimen or antigen detection (blood, CSF, sterile body fluid) Nucleic acid detection (blood, CSF, sterile body fluid), qualitative FIRST DETECTION ONLY Gram or other stain of direct specimen or antigen or nucleic acid detection (tissue) Histoplasma, Blastomyces, Coccidiodes, Paracoccidiodes, or Cryptoccocus All Positive for HBV, HCV, HIV Positive or detected Positive All FINAL: positive any organism Positive for Carbapenemase Positive All All Positive Positive for any microorganism

Positive for any micro-organism except HBV, HCV, HIV

Priority 3 (called 7am ­ 7pm M ­ F)

(For clients without electronic reporting)

Priority 2 (called 7am ­ 7pm 7 days) Age Low High

Priority 1 (called 24 hrs 7 days) Age

All All All

Age

Low

High

Low

High

Positive Positive Positive

All All

Positive Positive All Positive

< 13 y All

Positive Positive

All

Positive All All Detected PRELIM: positive any organism

All

All

All

All except for skin or wound

All

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Quest Diagnostics National Priority Value Tables by Testing Department

Microbiology / Serology

Analyte

neoformans isolated and/or detected by microscopy, nucleic acid or antigen tests Influenza A and/or B (includes positive H1N1 test results), culture, nucleic acid, or antigen test Legionella sp., culture, nucleic acid, or antigen test Malaria parasites or other organisms (Babesia, Ehrlichia, Trypanosomes etc.) [also appears in Hematology section] All Positive

Priority 3 (called 7am ­ 7pm M ­ F)

(For clients without electronic reporting)

Priority 2 (called 7am ­ 7pm 7 days) Age Low High

Priority 1 (called 24 hrs 7 days) Age Low High

Age

Low

High

All All

Positive Positive for any blood All parasites other than P falciparum

Positive for verified P falcparum or unspeci-ated Plasmodium sp." that are possibly P. falciparum

MRSA culture: Patients in institutional settings ONLY MRSA, PCR or other nucleic acid test Mucormycosis/Zygomycosis involving sino nasal area Mycobacteria all sp., stain or direct specimen nucleic acid test for M tuberculosis, initial detection Mycobacteria all sp., culture, initial detection and final identification. Mycobacteria tuberculosis, susceptibilities, resistant to 2 or more drugs Neisseria gonorheoeae, culture or nucleic acid test Nocardia species Pneumocystis jiroveci (carinii), stain or antigen test Respiratory syncytial virus (RSV), culture, nucleic acid or antigen test Rotavirus, antigen test Shiga Toxin, EIA Stool Culture, Shigella sp., Listeria sp., Salmonella sp., Campylobacter sp., Vibrio sp., and/or Yersinia enterocolitica Streptococcus, Group A, wound culture Streptococcus, Group B, culture or nucleic

All

Positive All All Detected Positive All Positive

All All < 13y All All >3y Positive 3y All All All

Positive Resistant 2 Positive Positive Positive Positive Positive Detected Positive

All <1y

Positive Positive

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Quest Diagnostics National Priority Value Tables by Testing Department

Microbiology / Serology

Analyte

acid test Ureaplasma urealyticum, culture, respiratory Vancomycin Intermediate or Resistant Staphylococcus aureus (VISA or VRSA) VRE culture VRE PCR or nucleic acid test Yersinia pestis, culture, nucleic acid, or antigen test All Positive All Detected All Positive <1y All Positive Vancomycin I or R

Priority 3 (called 7am ­ 7pm M ­ F)

(For clients without electronic reporting)

Priority 2 (called 7am ­ 7pm 7 days) Age Low High

Priority 1 (called 24 hrs 7 days) Age Low High

Age

Low

High

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Quest Diagnostics National Priority Value Tables by Testing Department

TDM / Toxicology

Analyte

Acetaminophen [mg/L] Acetone [mg/dL] Amikacin, random [mg/L] Amikacin, peak [mg/L] Amikacin, trough [mg/L] Amitriptyline + Nortriptyline total [mcg/L] Amobarbital [mg/L] Arsenic, Blood [mcg/L] Butalbital [mg/L] Cadmium, Blood [mcg/L] Cadmium, 24hr Urine [mcg/L] Caffeine [mg/L] Carbamazepine, total [mg/L] Carboxyhemoglobin [% of total Hgb] Chloramphenicol, random [mg/L] Chloramphenicol, peak [mg/L] Chloramphenicol, trough [mg/L] Chlordiazepoxide and Metabolite and (Desmethylchlordiazepoxide), total [mg/L] Chlorpromazine [ng/mL] Chlorpromazine [ng/mL] Clomipramine and Metabolite, total [ng/mL] Clorazepate as Nordiazepam [mg/L] Clozapine [ng/mL] Cobalt, Blood [mcg/L] Cobalt, Urine [mcg/L] Cyanide [mg/L] Cyclosporine, as Trough [mcg/L] Desethylamiodarone [mcg/mL] Desipramine [mcg/L] Diazepam and Nordiazepam, total [mg/L] Digitoxin [mcg/L] Digoxin [mcg/L] All All All All 301 ­ 599 2.1 ­ 2.9 36 ­ 44 2.1 ­ 2.9 All All All 250 0.5 ­ 0.9 400 ­ 599 All All All All All All All 1.0 600 > 2.5 600 3.0 45 3.0 All > 2.0 All All 900 400 1y All All All All All All 18 y < 18 y 30.1 ­ 49.9 12.1 ­ 19.9 15 ­ 19 > 25.0 > 25.0 > 20.0 > 5.0 300 ­ 749 80 ­ 749 All All All 750 750 600 <1y 40.0 ­ 49.9 All 10.0 ­ 29.9 All All All All All > 30.0 > 30.0 > 8.0 300 ­ 599 12.1 ­ 19.9 All > 60 All All All All All All > 10.0 30.0 > 10.0 50.0 20.0 20 All 600 ­ 999 All All 1000 20.0

Priority 3 (called 7am ­ 7pm M ­ F)

(For clients without electronic reporting)

Priority 2 (called 7am ­ 7pm 7 days) Age Low High

Priority 1 (called 24 hrs 7 days) Age

All All

Age

Low

High

Low

High

50 50

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Quest Diagnostics National Priority Value Tables by Testing Department

TDM / Toxicology

Analyte

Disopyramide [mg/L] Doxepin + Nordoxepin, total [mcg/L] Ethanol [mg/dL] Ethosuximide [mg/L] Ethylene glycol [mg/L] Flecainide [mg/L] Fluoxetine [mcg/L] Fluphenazine [mcg/L] Norfluoxetine [mcg/L] Gentamicin, random [mg/L] Gentamicin, peak [mg/L] Gentamicin, trough [mg/L] Haloperidol, Serum [ng/mL] Ibuprofen [mg/L] Imipramine or Desipramine, total [mcg/L] Isopropanol [mg/dL] Lead, blood [mcg/dL] Lead, 24hr Urine [mcg/L] Levetiracetam, peak [mg/L] Levetiracetam, trough [mg/L] Lidocaine [mg/L] Lithium [mEq/L] Mephobarbital [mg/L] Mercury, Blood [mcg/L] Mercury, Urine, 24 hr [mcg/L] Mercury, Urine, Random [mcg/g creatinine] Mesoridazine [mg/L] Methanol [mg/dL] Methemoglobin [% of total Hgb] Methotrexate at 24 h [µmol/L] Methsuximide, as Normethsuximide [mg/L] Mexiletine [mg/L] Mycophenolic Acid [mcg/mL] All All 0.5 - 1.0 2.0 ­ 4.9 > 3.5 All 12.0 ­ 69.9 All All All All All All All 5.1 ­ 5.9 1.6 ­ 1.9 40.1 ­ 59.9 > 13 36 ­ 149 36 ­ 149 > 1.4 All All All All All All < 0.5 5 70.0 5.00 > 40.0 5.0 All All 150 150 6y > 40 <6y All All All 20 ­ 44 120 > 70 > 37 All All All 6.0 2.0 60.0 All All 75 ­ 99 301 ­ 599 All All All All All All > 469 18 ­ 49 > 446 > 10.0 > 10.0 > 2.0 All > 20 All All All < 18 y 100 600 50 45 All 50 All 101 ­ 149

Priority 3 (called 7am ­ 7pm M ­ F)

(For clients without electronic reporting)

Priority 2 (called 7am ­ 7pm 7 days) Age Low High

Priority 1 (called 24 hrs 7 days) Age

All All All All All All

Age

All All

Low

High

5.1 ­ 6.9 300 ­ 599

Low

High

7.0 600 250 150 100 1.0

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Quest Diagnostics National Priority Value Tables by Testing Department

TDM / Toxicology

Analyte

Mycophenolic Acid Glucoronide [mcg/mL] Nortriptyline [mcg/L] Phenobarbital [mg/L] Phenytoin [mg/L] Phenytoin, free [mg/L] Primidone [mg/L] Procainamide [mg/L] Procainamide + NAPA total [mg/L] Protriptyline [mcg/L] Propafenone [mg/L] Quinidine [mg/L] Salicylates [mg/L] Sirolimus (Rapamycin) [mcg/L] Immunoassay Tacrolimus (FK 506) [mcg/L] Theophylline [mg/L] Theophylline [mg/L] Thioridazine [mg/L] Tobramycin, random [mg/L] Tobramycin, peak [mg/L] Tobramycin, trough [mg/L] Thallium, Blood [mcg/L] Thallium, Urine, 24 hr [mcg/L] Trazodone [mcg/L] Valproic Acid [mg/L] Vancomycin, random [mg/L] Vancomycin, peak [mg/L] Vancomycin, trough [mg/L] Zonisamide [mg/L] 6m All All All All All All All All All All All All 20.1 ­ 39.9 > 2.6 > 10.0 > 10.0 > 2.0 6 ­ 79 6 ­ 199 > 2,100 100.1 ­ 149.9 40.1 ­ 79.9 40.1 ­ 79.9 > 20.0 > 40 All All All All 150.0 80.0 80.0 80.0 All All 80 200 All All 3.0 ­ 4.9 35.0 > 20.0 All 5.1 ­ 9.9 All 261 ­ 499 All All 12.1 ­ 15.0 12.0 ­ 13.9 All All All 250 ­ 499 40.1 ­ 59.9 35.1 ­ 39.9

Priority 3 (called 7am ­ 7pm M ­ F)

(For clients without electronic reporting)

Priority 2 (called 7am ­ 7pm 7 days) Age

All

Priority 1 (called 24 hrs 7 days) Age

All All All All All All All All All All All All All <6m 6m <3.0 < 3.0 > 10.0 40.0

Age

Low

High

Low

< 35.0

High

Low

High

500 60.0 40.0 > 3.0 > 15.0 14.0 > 30.0 > 500 > 2.0 10.0 400

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Quest Diagnostics National Priority Value Tables by Testing Department

Genetic Testing

Analyte Ashkenazi Jewish Panel (8 test or 11 test) Bloom Syndrome DNA Mutation Analysis Canavan Disease Mutation Analysis Cystic Fibrosis Screen Familial Dysautonomia Mutation Analysis Fanconi's Anemia DNA Mutation Analysis Gaucher Disease, DNA Mutation Analysis Glycogen Storage Disease Type Ia Mutation Analysis Maple Syrup Disease (MSUD) Mutation Analysis (Ashkenazi Jewish) Mucolipidosis Type IV Mutation Analysis Niemann-Pick Disease Mutation Analysis Spinal Muscular Atrophy (SMA) Mutation Analysis Tay-Sachs Disease Mutation Analysis Amniotic fluid open neural tube defect screen XSense, Fragile X with Reflex Maternal Serum Biochemical Screening MOM value 2.0 MOM Gray zone, pre-mutation or affected result MSS Interpretation- Screen positive for ONTD, Down syndrome and/or trisomy 18 or High risk for Down syndrome and/or trisomy 18 Note: Homozygous disease states are directly called by the Genetic Counseling Team in accordance with Quest Diagnostics Nichols Institute Policies. Heterozygous for mutation or not interpretable Priority 3 (called 7am ­ 7pm M ­ F)

(For clients without electronic reporting)

Priority 2WD (called 7am ­ 7pm weekdays ONLY) Age Low High

Priority 1 (called 24 hrs 7 days) Age Low High

Age

Low

High

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Quest Diagnostics National Priority Value Tables by Testing Department

Pathology / Hematopathology

Analyte

Gyn Cytology (Pap)

Priority 3 (called 7am ­ 7pm M ­ F)

(For clients without electronic reporting)

Priority 2 (called 7am ­ 7pm 7 days) Age Low High

Priority 1 (called 24 hrs 7 days) Age Low High

Age

Low

High

· HSV, if pregnancy indicated in LIS · Adenocarcinoma in situ · Suspicious for malignancy · Positive for malignancy** · Suspicious for malignancy · Positive for malignancy** · Positive for acute leukemia (initial or recurrence) · POC without identifiable placental villi or fetal parts · Suspicious for malignancy** · Positive for malignancy** · Significant unexpected surgical pathology findings as determined by pathologist · First time diagnosis of acute promyelocytic leukemia · Frozen section results · Presence of adipose tissue in an endometrial biopsy

Non ­ Gyn Cytology Hematopathology (including Flow Cytometry, FISH, and Molecular) Tissue Biopsy

** Excluding squamous/basal cell skin carcinomas and/or re­excision of known recently diagnosed malignancy but includes cases in which biopsy is a follow-up to cytologic report. It is not intended that pre-malignant conditions such as CIN3, high grade PIN, complex endometrial hyperplasia, etc. be considered "Suspicious for Malignancy" unless the pathologist has made an additional comment to that effect. The BU Medical Director may add additional case findings to the list (e.g., bcc/scc with positive margins on an excisional biopsy).

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Priority Value Tables

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