Reflex Test Protocols Reflex tests fall into 2 categories: standard industry practice (example: sensitivities, interpretations, and confirmations) and institutional practice based on staff clinical practice Tests that are reflexed should be reasonable and medically necessary. The medical community should approve reflex protocols. The physician must have the option of selecting a reflex protocol or a single test. Blood Transfusion Services Antibody Screen Antibody Screen Positive screen Antibody identification Cold agglutinin screen Cold agglutinin screen Positive (>1+) Cold agglutinin titer Direct antiglobulin test Direct antiglobulin test IgG positive and transfused w/in 3 Eluate mo Fetal Screen Fetal screen Positive Kleihauer-Betke Core Lab - Chemistry Thyroid Screen TSH TSH>5.00 Free T4 TSH<0.40 Free T4. T3 Monitoring L-T4 Therapy TSH TSH<0.05 Free T4 Thyroglobulin Thyroglobulin Specimen received and test requested Thyroglobulin Antibodies Direct LDL Lipid Panel with calculated LDL Triglycerides >399 Direct (measured LDL) Free testosterone Total testosterone, sex hormone binding globulin (SHBG), albumin, free testosterone (calculated), % free testosterone (calculated). Albumin <3.5 Notes: The albumin is needed for the calculation but will not be reported. All other values will be reported. If the total testosterone is outside of the measurement range, free testosterone and % free testosterone will not be reported. Free testosterone measured by equilibrium dialysis Core Lab - Emergency Department Urinalysis Macroscopic urinalysis 1+, 2+, 3+ for blood protein, Microscopic leukocytes Troponin-l Troponin-l Borderline or positive Troponin-T Rapid Influenza screen Rapid flu screen Admission samples Confirmation in main Microbiology Rapid Influenza screen Rapid flu screen Negative on Pediatric case and at Viral Panel in main Microbiology request of MD Rapid Strep A Antigen Strep screen Presumptive negative Confirmation on second swab in main Microbiology Cytology Test ordered on Requisition Initial Test Performed Criteria for Reflex Test Ordered by Reflex Pap Smear Liquid-based PAP Atypical cytology HPV test Anal Pap Smear Liquid-based PAP Atypical cytology HPV test Diabetes Hemoglobin A1C Hemoglobin A1C >4.50% or <14.50% Calculated mean blood glucose MGH Approved by Medical Policy Aug, 2016
Health Centers Chelsea and Revere Urinalysis UA-Macroscopic Any of the following Urine Sediment Protein:1+ or more Blood: Trace or more Leukocyte esterase: Positive CBC MCHC>38.0 Manual hematocrit Differential Manual Differential Manual - Clinical requests pathologist review - Blasts seen - Unusual abnormal white cells Rapid Influenza screen Rapid flu screen Admission samples Confirmation in main Microbiology Rapid Influenza screen Rapid flu screen Negative on Pediatric case and at Viral Panel in main Microbiology request of MD Rapid Strep A Antigen Strep screen Presumptive negative Confirmation on second swab in main Microbiology Core Lab - Hematology Hemoglobin electrophoresis Hemoglobin fractionation Test performed No concurrent CBC Pathologist review of results. Pathologist review of peripheral blood smear if abnormal findings seen on hemoglobin electrophoresis. CBC Sickle screen Sickle screen Previous positive Test result Hemoglobin electrophoresis Urinalysis Macroscopic urinalysis Positive WBC screen occult blood Microscopic or >TRACE albumin (i.e., 1+ or more) CBC CBC Instrument flag PLT first time <50,000 PLT review on smear Manual Platelet Instrument flag RBC > 7.0 million/ul Manual hematocrit; other RBC parameters not reported MCHC > 38.0 Manual hematocrit Differential Differential-automated Instrument flag Differential or automated differential with manual review Differential-manual Differential-manual Clinician request Pathologist review Blasts seen for first time on the patient Unusual abnormal white cells PT PT >138 and/or reason to query accuracy of result e.g. low fibrinogen Manual PT (and fibrinogen when initial PT >138) interfering substance (lipemia, gross hemolysis) Instrument flag MGH Approved by Medical Policy Aug, 2016
Hematology Pathology Bone Marrow Exam Specimen received and test request Pathologist review of blood smear (from CBC ordered <24 hours prior to bone marrow sample or slide from CBC with manual differential/special slide ordered < 7 days prior to bone marrow) Flow cytometry for hematologic malignancy Specimen received and test request CBC with differential, special slide and pathologist review. CSF Flow Cytometry Ordered CSF Total Nucleated TNC> 5/µL or history of CSF flow cytometry Cell Count (TNC) Chart review for history of hematologic malignancy Lymphoma staging bone marrow Morphologic examination by a hematopathologist Flow cytometry IHC as needed Bone marrow examination for suspected acute leukemia Morphologic examination by a hematopathologist Flow cytometry IHC as needed hematologic malignancy Clinician requests policy override Pancytopenia or question of MDS Flow, morphology and or IHC positive for lymphoma No evidence of marrow involvement by lymphoma based on flow, morphology or IHC Diagnosis AML APML (If reflex criteria not met, flow cytometry will not be performed by default, but clinician may request override) Routine cytogenetics Cytogenetics with stimulation Cytogenetics not performed (test cancelled by Hematopathology). Molecular Add-on tests SNaPshot, FLT3, NPM1, CEBPA SNaPshot, FLT3, PML-RARA B-ALL MDS MPN or MDS/MPN overlap CMML Other BCR-ABL qualitative SNaPshot JAK2 V617F and SNaPshot SNaPshot, NPM1, FLT3 Discuss with clinician MGH Approved by Medical Policy Aug, 2016
Immunology Protein electrophoresis on serum or CSF Protein electrophoresis on agarose gel Presence of 1 or more abnormal bands in the gamma globulin zone Immunofixation to characterize abnormal bands with physician Protein electrophoresis on serum or CSF Protein electrophoresis on serum, urine, CSF Urine Bence Jones proteins Protein electrophoresis on agarose gel Protein electrophoresis on agarose gel Agarose gel electrophoresis and immunoelectrophoresis Presence of abnormal banding and altered immunoglobulin profile Test performed Abnormal band on agarose gel not identified by immunoelectrophoresis review Immunofixation to characterize abnormal bands and, as needed, free kappa and lambda light chains by nephelometry with physician review Physician review Immunofixation to characterize abnormal bands and, as needed, free kappa and lambda light chains by nephelometry with physician review ANA Titre and pattern Physician review Viscosity Antinuclear antibody ANA screen Presence of staining of substrate nuclei or cytoplasm Quantitation of serum IgG, IgA, IgM by nephelometry If lgg>7 g/dl, lga >3 g/dl, or lgm immunoglobulins >5 g/dl Quantitation of serum lgg lgg by nephelometry <500 mg/dl and adult patient Immunofixation electrophoresis, and, as needed, free kappa and lambda light chains by nephelometry and physician review of findings Cryocrit Cryoprecipitable protein Cryoprecipitable protein present If not previously tested within 6 months to 1 year, cryoprecipitable protein is identified by immunodiffusion, immunofixation, and physician review ENA panel (Ro/La/Sm/RNP/Jo/Sci-70) ELISA If ELISA positive for any antigens in ENA panel Perform ANA test on Hep2 cells if not already performed within last 2 months MGH Approved by Medical Policy Aug, 2016
Microbiology Routine culture on CSF Culture Cloudy fluid Gram stain Lower respiratory culture Culture Evaluation of specimen quality Gram stain Lower female tract culture Culture Diagnosis of bacterial vaginosis Gram stain made by gram stain not culture. Culture performed for yeast and GC Gram stain Gram stain Presence of potential pathogens observed TB, fungal or anaerobic cultures and/or smears Brain abscess Routine culture Specimen site Anaerobic culture Gram stain routine culture Bacterial cultures Routine Culture Isolation of clinically significant organisms requiring susceptibility Isolation of methicillin resistant Staph aureus from blood, body fluid, or wound Staphylococci from blood, body fluid, or wound that require confirmation of methicillin test Isolation of certain gram negative bacilli resistant to 3rd generation cephalosporins MGH Approved by Medical Policy Aug, 2016 Susceptibility testing Vancomycin MIC to check for VISA or VRSA Confirmatory test for the presence or absence of the MecA gene or the gene product PBP 2a for certain staphylococci Confirmatory test for presence of extended-spectrum B- lactamases Mycobacterial culture Mycobacterial culture Isolation of clinically significant Susceptibility testing organisms Mycobacterial culture from Mycobacterial culture Body site AFB smear normally sterile body site AFB Mycobacterial culture Test order AFB smear HSV Culture on CSF HSV PCR Lyme serology Lyme serology by EIA Positive Immunoblot IgG and IgM Syphilis antibody screen (ELISA) Syphilis antibody screen (ELISA) Positive Syphilis antibody screen (ELISA) RPR, RPR titer, alternative treponemal specific testing if Ova & Parasites or Blood parasites Viral antigen O&P or Blood Parasite Respiratory pool with 7 viral antigens Isolation of clinically significant parasite Positive for specific virus in pool Viral respiratory culture Respiratory pool with 7 viral antigens Antigens are recommended test Complete viral culture on nonrespiratory Viral culture and CMV shell vial Shell vial culture is recommended tissue culture test HSV(PCR) M. pneumoniae (PCR) Hep C Virus (PCR) Hepatitis C genotyping HIV serology and viral load Pneumocystis exam Viral hepatitis serology Lyme immunoblot Anaerobic culture Anaerobic culture Gram stain Gram stain results dictate additional media for optimal organism recovery Routine culture on specimen from Culture Specimen obtained surgically and OR coming from the OR Culture of blood or normally sterile Routine culture for yeast and Yeast growth sites Blood culture Stool examination for O&P (Ova and Parasites) bacteria Blood culture followed by gram stain if growth is detected Direct immunofluorescent assay for Giardia and Cryptosporidium Presence of gram-positive or negative bacteria or yeast Submission of completed patient history form needed Parasite identification Parasite count Hatching test Any one of the following: Adenovirus Parainfluenza 1,2,3 Influenza A & B RSV All of the following listed above. CMV shell vial culture Pathologist review with interpretation Gram stain Gram stain Antifungal susceptibility on yeast isolates Multiplex molecular test for organism identification and detection of resistance markers Permanent stained smear, concentration with wet mount
HCV Genotyping (added 1/06) HIV Genotyping (added 1/06) or NAAT for Giardia, Cryptosporidium and Entamoeba histolytica No Hepatitis C Viral Load performed at MGH within previous 30 days. No HIV viral load performed at HCV Quantitative Viral Load HIV Quantitative Viral Load MGH within previous 30 days Malaria Screen BINAX rapid screen Positive BINAX test Thick and thin smear for confirmation, parasite burden, and speciation Clostridium difficile toxin assay Ehrlichia-PCR (or synonym) Anaplasma-PCR (or synonym) Ehrlichia/ Anaplasma PCR (or synonym) Herpes simplex virus (HSV) culture or direct fluorescence antibody detection (DFA) Influenza PCR or Respiratory syncytial virus (RSV) PCR Nucleic acid amplification test (NAAT) for Chlamydia trachomatis or Neisseria gonorrhoeae Combination assay for GDH and Toxins A&B Ehrlichia/ Anaplasma molecular detection Indeterminate result NA HSV DFA Negative HSV DFA HSV culture PCR for Influenza A, Influenza B and RSV NAAT for both Chlamydia trachomatis and Neisseria gonorrhoeae Test order for any of these viruses NAAT test order for either Chlamydia trachomatis or Neisseria gonorrhoeae PCR assay for toxigenic C. difficile NA PCR for Influenza A, Influenza B and RSV will performed in all cases NAAT for both Chlamydia trachomatis and Neisseria gonorrhoeae Molecular Pathology Test ordered Initial Test Performed Criteria for Reflex Test Ordered by Reflex A pathologist review and written interpretation accompany all results of molecular pathology tests. MGH Approved by Medical Policy Aug, 2016
Special Coagulation Lupus anticoagulant Screen Positive Screen Lupus anticoagulant confirmation; anticardiolipin antibody added even if lupus anticoagulant is negative. Factor VIII, IX, XI to rule-out factor inhibitor causing false positive results Protein C Protein C functional <70% activity Antigenic Protein C, Factor VII if indicated to distinguish between hereditary and acquired etiologies. Antithrombin III Functional Antithrombin III <70% activity Antigenic Antithrombin III Protein S Functional Protein S <70% activity Free Protein S antigen, fibrinogen and functional FVIII activity Activated protein C resistance or Activated protein C resistance 2.1 Factor V Leiden by DNA assay Factor V Leiden Prolonged PT Evaluation (mixing studies) Prolonged PTT Evaluation (mixing studies) PT, removal of heparin if PTT also prolonged, mixing study PTT, removal of heparin, mixing study Mixing study normal, prolonged, or "fades" Mixing study normal, prolonged, or "fades" Lupus anticoagulant Factor assays, lupus anticoagulant, and/or factor inhibitor tests if indicated Factor assays if mix is normal; lupus anticoagulant if mix is prolonged, factor VIII if mix "fades"; all three tests if mix results inconclusive; factor inhibitor tests if indicated Multiple individual hypercoagulation tests As ordered Patient not on coumadin or other reason for not performing tests. If missing a test from the usual screen (activated protein C resistance, protein C, protein S, antithrombin, Lupus anticoagulant, Anticardiolipin, prothrombin G20120A), it will be included Reptilase time Reptilase time > 24 seconds Fibrinogen Degradation Products Factor V, factor II, or factor x As ordered The medical record indicates the clinician wanted factor V Leiden, prothrombin G20210A ("factor II"), or a chromogenic factor X or antifactor Xa (or D Dimer), Fibrinogen The appropriate test will be performed as indicated by the patient's medical record A written pathologist's interpretation accompanies all results of complex coagulation tests, including mixing studies, hypercoagulation studies, antiphospholipid antibody studies, factor assays, von Willebrand tests, platelet aggregation studies, and in some cases anti-factor Xa assays (heparin, low-molecular weight heparin, and Fondaparinux drug levels). MGH Approved by Medical Policy Aug, 2016