Policy for Priority Result Reporting

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1 Policy for Priority Result Reporting Purpose/Introduction The Quest Diagnostics Priority Result Reporting Policy describes the reporting of test results assigned a variable level of Priority (P1, P2, or P3) depending on thresholds established and amended by medical consensus and approval of the Chief Laboratory Officer. 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 requests the test is responsible for providing 24-hour reliable contact information for the purpose of priority reporting. Information may only be provided to someone who indicates they have the authority to accept the communication. We will notify the ordering provider or authorized representative as permitted or required by state and federal law. Thereafter, the provider or authorized representative 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, they have a responsibility to communicate the information to a qualified person immediately. Priority Level Definitions Priority-1 test results are reported 24 hours/day and 7 days/week and include results considered critical according to the Clinical Laboratory Improvement Amendments of 1988 (CLIA; CFR f) and the CAP Laboratory Accreditation Program. Priority-2 test results are reported 9am to 7pm, 7 days/week and include results that may require attention prior to the receipt of routine laboratory reports. Tests marked Priority 2WD are called during office hours, between 9 am and 4 pm weekdays, or other hours if known to our Client Services team. 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 test results are only verbally communicated to clients with no electronic means of receiving patient reports (e.g., mailed or courier-delivered reports), or clients who have requested P3 reporting in writing. These are test results are generally reported during regular client office hours, e.g. 9am 5pm. The attached Priority Value Table will not be modified (changed, deleted from, or added to) without the signed written request of the client. Sincerely, Stephen C. Suffin, M.D. Quest Diagnostics Vice President & Chief Laboratory Officer Quest Diagnostics Priority Result Reporting Policy (client synopsis) Version 12.0 revised 7/01/14

2 Chemistry / Special Chemistry Priority 1 (called 24 hrs 7 days) Priority 2 (called 9am 7pm 7 days) Ammonia [umol/l] 18 y >200 Amylase [U/L] 300 Bilirubin, total [mg/dl] 2 y y Bilirubin, total [mg/dl] >2 y >20.0 BUN [mg/dl] 100 Calcium, total [mg/dl] Calcium, ionized [mg/dl] 3.2 >6.9 CK MB CK [U/L] 18 y >positive cutoff value (varies with assay) 1000 >18 y 6000 Creatinine [mg/dl] 8.00 Galactose, urine [mg/dl] 2 y >70 Galactose 1 Phosphate [mg/dl packed RBC] 2 y >5.0 Glomerular Basement Membrane Antibody IgG [AI] (Bioplex assay) Glomerular Basement Membrane Antibody IgG [Units] (Inova assay) Glucose, serum [mg/dl] * Glucose results are flagged P1 P3 regardless of ordered test (OGTT, random glucose, serum or plasma). When results are called to the client, the report title of the test result should be made known to the client. >8.0 >40 Glucose, CSF, [mg/dl] <30 < Iron (serum) [mcg/dl] 12 y 500 Lipase [U/L] 180 Magnesium, serum or plasma [mg/dl] Phosphate (as phosphorous), serum or plasma [mg/dl] 1.0 Potassium, serum or plasma [mmol/l] Sodium, serum or plasma [mmol/l] Page 1 of 12

3 Chemistry / Special Chemistry Priority 1 (called 24 hrs 7 days) Priority 2 (called 9am 7pm 7 days) Transferrin, Beta-2 Troponin (I or T) [ng/ml] >cutoff value (Detected) TSH [miu/l] 1 y Uric Acid [mg/dl] >14.0 Viscosity, serum [relative to water] 3.0 Page 2 of 12

4 Hematology / Coagulation / Urinalysis Priority 1 (called 24 hrs 7 days) Priority 2 (called 9am 7pm 7 days) Blasts, absolute number [/ul] Cerebrospinal fluid (CSF) 50,000 on any patient Any abnormal per local Medical Director Coagulation Factors VIII & IX, Activity [%] <5 Coagulation Factor XIII, Activity [%] <20 Coagulation Factor VIII, IX and XI Inhibitor [Bethesda Unit] Blasts >0 (new patient only) >2 Cryoglobulin [%] 3 Fibrinogen Clotting Activity, Clauss Method [mg/dl] <50 Heparin [IU/mL] >2.0 Heparin-Induced Platelet Antibody Serotonin Release Assay [%] 20 ADAMTS13 Activity reflex to Inhibitor (Von Willebrand Factor Protease Cleaving Activity) [%] Glucose, urine (Urinalysis) Hemoglobin [g/dl] Malaria parasites or other organisms (Babesia, Ehrlichia, Trypanosomes etc.) [also appears in Microbiology section] y < y >12 y >12 y for P. falciparum or unspeciated Plasmodium species that are possibly P. falciparum WBC, absolute number [/ul] <1,000 for blood parasites other than P. falciparum Neutrophils, absolute number [/ul] <400 >30,000 Band neutrophils, absolute number [/ul] >10,000 Partial Thromboplastin Time, (aptt) [sec.] Platelet Count, absolute number [/ul] <20,000 2,000,000 Prothrombin Time - International Normalized Ratio (PT-INR) 16 y 20,000 50, or higher 1,000,000 1,999, Reducing Substance (Urinalysis, Clinitest) 2 y Page 3 of 12

5 Microbiology / Serology Priority 1 (called 24 hrs 7 days) Priority 2 (called 9am 7pm 7 days) Aspergillus galactomannan antigen, serum or bronchoalveolar lavage Bacillus anthracis, culture, nucleic acid, or antigen test Bacterial meningitis antigens, CSF Detected 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 and GDH Antigen positive, or positive PCR, cytotoxicity assay or toxigenic culture (Note: non-toxigenic strains should not be called) Corynebacterium diphtheriae, nasopharynx culture Cryptococcus antigen, serum or CSF Detected Culture: blood, CSF, any tissue or sterile body fluid (excluding urine) PRELIM: positive any organism <13 y Detected FINAL: positive any organism 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 or quantitative FIRST DETECTION ONLY Gram or other stain of direct specimen or antigen or nucleic acid detection (tissue) for any microorganism for any microorganism except HBV, HCV, HIV except for skin or wound for HBV, HCV, HIV or Detected Page 4 of 12

6 Microbiology / Serology Priority 1 (called 24 hrs 7 days) Priority 2 (called 9am 7pm 7 days) Histoplasma, Blastomyces, Coccidiodes, Paracoccidiodes, Cryptoccocus neoformans or Cryptococcus gattii 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.) MRSA culture: Patients in institutional settings ONLY for P. falciparum or unspeciated Plasmodium species that are possibly P. falciparum for blood parasites other than P. falciparum MRSA, PCR or other nucleic acid test Detected Mucormycosis/Zygomycosis involving sinonasal 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 Resistant 2 <13y Nocardia species Norovirus PCR or Antigen Pneumocystis jiroveci (carinii), stain or antigen or nucleic acid test Respiratory syncytial virus (RSV), culture, nucleic acid or antigen test Rotavirus, antigen test Shiga Toxin, EIA Detected 3 y >3 y Page 5 of 12

7 Microbiology / Serology Priority 1 (called 24 hrs 7 days) Priority 2 (called 9am 7pm 7 days) 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 acid test <1 y Ureaplasma urealyticum, culture, respiratory <1 y Vancomycin Intermediate or Resistant Staphylococcus aureus (VISA or VRSA) Vancomycin I or R VRE culture VRE PCR or nucleic acid test Detected Yersinia pestis, culture, nucleic acid, or antigen test Page 6 of 12

8 TDM / Toxicology Priority 1 (called 24 hrs 7 days) Priority 2 (called 9am 7pm 7 days) Acetaminophen [mg/l] 50 Acetone [mg/dl] 50 Amikacin, random [mg/l] >30.0 Amikacin, peak [mg/l] >30.0 Amikacin, trough [mg/l] >8.0 Amitriptyline + Nortriptyline, total [mcg/l] Amobarbital [mg/l] Arsenic, blood [mcg/l] >60 Butalbital [mg/l] >10.0 Cadmium, blood [mcg/l] Cadmium, 24hr urine [mcg/l] >10.0 Caffeine [mg/l] 50.0 <1 y y Carbamazepine, total [mg/l] Carboxyhemoglobin [% of total Hgb] Chloramphenicol, random [mg/l] >25.0 Chloramphenicol, peak [mg/l] >25.0 Chloramphenicol, trough [mg/l] >20.0 Chlordiazepoxide and Metabolite and Desmethylchlordiazepoxide, total [mg/l] >5.0 Chlorpromazine [ng/ml] y Chlorpromazine [ng/ml] 750 <18 y Clomipramine and Metabolite, total [ng/ml] 600 Clozapine [ng/ml] 900 Clorazepate as Nordiazepam [mg/l] >2.0 Cobalt, blood [mcg/l] 400 Cobalt, urine [mcg/l] 250 Cyanide [mg/l] Cyclosporine, trough [mcg/l] Desethylamiodarone [mcg/ml] >2.5 Desipramine [mcg/l] Diazepam and Nordiazepam, total [mg/l] Digoxin [mcg/l] Page 7 of 12

9 TDM / Toxicology Priority 1 (called 24 hrs 7 days) Priority 2 (called 9am 7pm 7 days) Disopyramide [mg/l] Doxepin + Nordoxepin, total [mcg/l] Ethanol [mg/dl] 250 Ethosuximide [mg/l] Ethylene glycol [mg/l] 100 Flecainide [mg/l] 1.0 Fluoxetine [mcg/l] >469 Fluphenazine [mcg/l] Norfluoxetine [mcg/l] >446 Gentamicin, random [mg/l] >10.0 Gentamicin, peak [mg/l] >10.0 Gentamicin, trough [mg/l] >2.0 Haloperidol, serum [ng/ml] >20 Ibuprofen [mg/l] Imipramine or Desipramine, total [mcg/l] Isopropanol [mg/dl] 50 Lead, blood [mcg/dl] <18 y 45 <6 y y >40 Lead, 24hr urine [mcg/l] 120 Levetiracetam, peak [mg/l] >70 Levetiracetam, trough [mg/l] >37 Lidocaine [mg/l] Lithium [mmol/l] Meconium Drug Testing (confirmation) Mephobarbital [mg/l] Mercury, blood [mcg/l] >13 Mercury, urine, 24 hr [mcg/l] Mercury, urine, random [mcg/g creatinine] Mesoridazine [mg/l] >1.4 Methanol [mg/dl] 5 Methemoglobin [% of total Hgb] Methotrexate at 24 h [µmol/l] 5.00 Methsuximide, as Normethsuximide [mg/l] >40.0 Page 8 of 12

10 TDM / Toxicology Priority 1 (called 24 hrs 7 days) Priority 2 (called 9am 7pm 7 days) Mexiletine [mg/l] Mycophenolic Acid [mcg/ml] < >3.5 Mycophenolic Acid Glucoronide [mcg/ml] <35.0 Nortriptyline [mcg/l] Phenobarbital [mg/l] Phenytoin [mg/l] Phenytoin, free [mg/l] >3.0 Primidone [mg/l] > Procainamide [mg/l] Procainamide + NAPA, total [mg/l] >30.0 Protriptyline [mcg/l] > Propafenone [mg/l] >2.0 Quinidine [mg/l] Salicylates [mg/l] 400 Sirolimus (Rapamycin) [mcg/l] < Tacrolimus (FK 506) [mcg/l] < >20.0 Theophylline [mg/l] <6 m >10.0 Theophylline [mg/l] 6 m m Thioridazine [mg/l] >2.6 Tobramycin, random [mg/l] >10.0 Tobramycin, peak [mg/l] >10.0 Tobramycin, trough [mg/l] >2.0 Thallium, blood [mcg/l] Thallium, urine, 24 hr [mcg/l] Trazodone [mcg/l] >2,100 Valproic Acid [mg/l] Vancomycin, random [mg/l] Vancomycin, peak [mg/l] Vancomycin, trough [mg/l] 80.0 >20.0 Zonisamide [mg/l] >40 Page 9 of 12

11 Genetic Testing Analyte Ashkenazi Jewish Panel (4, 11, or 18 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 Tay-Sachs Disease Mutation Analysis Amniotic fluid open neural tube defect screen XSense, Fragile X with Reflex Maternal Serum Biochemical Screening SMA Carrier Screen SMA Diagnostic Test Achondroplasia Mutation Alpha-1 Antitrypsin (AAT) Mutation Analysis Alpha-Globin Common Mutation Analysis Alpha-Globin Gene Deletion or Duplication Beta Globin Gene Dosage Analysis Beta-Globin Complete CAH (21-Hydroxylase Deficiency) Common Mutations Cystic Fibrosis D1152H Mutation Analysis Cystic Fibrosis Gene Deletion or Duplication Dihydrolipoamide Dehydrogenase Deficiency Dihydropyrimidine Dehydrogenase (DPD) Gene Mutation Analysis Factor V Leiden Factor XI Mutation Analysis (Ashkenazi Jewish) Familial Hyperinsulinism Priority 2WD (called 9am 5pm Mon-Fri ONLY) Result Heterozygous for Mutation or Not Interpretable Note: Homozygous disease states are handled by the Genetic counseling team in accordance with SOP # 245SM029 MOM value 2.0 MOM Gray zone, pre-mutation or full mutation affected result MSS Interpretation- Screen positive for ONTD, Down syndrome and/or trisomy 18 or High risk for Down syndrome and/or trisomy 18 One copy of the SMN1 gene detected One copy of the SMN1 gene detected positive Homozygous positive and positive for z and s for MED, FILL, SEA, THAI, ALPHA 20.5; for at least 2 gene deletions Deletion of 2, 3 or 4 alpha globin genes positive positive positive positive positive Heterozygous and homozygous positive Homozygous positive Page 10 of 12

12 Genetic Testing Analyte Familial Mediterranean Fever Mutation Analysis Galactosemia Mutation Analysis Huntington Disease Mutation Analysis Joubert Syndrome Long Chain Acyl-CoA Dehydrogenase (LCHAD) Mutation Analysis Medium Chain Acyl-CoA Dehydrogenase (MCAD) Mutation Analysis MEN2 and FMTC Mutations, Exons 10, 11, Nemaline Myopathy Phenylketonuria (PKU) Mutation Analysis Prader-Willi/Angelman Syndrome, DNA Methylation Analysis Prothrombin (Factor II) 20210G>A Mutation Analysis Rett Syndrome Mutation Analysis Rett Syndrome Rearrangement (Deletion or uplication TPMT Genotype UGT1A1 Gene Polymorphism (TA Repeat) Usher Syndrome Type IF Usher Syndrome Type III Walker-Warburg Syndrome Y Chromosome Microdeletion, DNA Analysis Priority 2WD (called 9am 5pm Mon-Fri ONLY) Result positive positive Affected, intermediate positive positive positive positive positive Homozygous positive positive positive Intermediate metabolizer, poor metabolizer Homozygous for the ta7 polymorphism positive Page 11 of 12

13 Pathology / Hematopathology Priority 1 (called 24 hrs 7 days) Ordered Test Interpretation Interpretation Priority 2 (called 9am 7pm 7 days) Herpes changes, if pregnancy indicated in LIS Gyn Cytology (Pap) Adenocarcinoma in situ Suspicious for malignancy for malignancy** Non Gyn Cytology Suspicious for malignancy for malignancy** Hematopathology (including Flow Cytometry, FISH, and Molecular) First time diagnosis of acute promyelocytic leukemia for acute leukemia (initial or recurrence) Tissue Biopsy Frozen section results Presence of adipose tissue in an endometrial biopsy POC without identifiable placental villi or fetal parts Suspicious for malignancy** for malignancy** Significant unexpected surgical pathology findings as determined by pathologist ** Excluding squamous/basal cell skin carcinomas and/or re-excision of known recently diagnosed malignancy but includes cases in which biopsy is a follow-up to cytology 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. Page 12 of 12

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