Beth Israel Deaconess Medical Center
Laboratory Manual
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Beth Israel Deaconess Medical Center Laboratory Manual |
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Introduction: The clinical laboratories at Beth Israel Deaconess Medical Center accept specimens, perform tests, report results, and bill for tests in accordance with federal Medicare regulations. The laboratories encourage physicians to order tests individually, based on medical necessity.
Individual tests versus test panels: Although individual test ordering is routine, some tests are more appropriately ordered in sets (test panels). This may be either because the indication for the test routinely encompasses multiple assays (panel test), or because an abnormal result will routinely requires additional testing for a complete medical evaluation (panel test with reflex testing ).
HCFA (Medicare) and BIDMC panels: In a few situations, the ordering of specific collections of tests (test panels) has been approved by HCFA (Medicare). BIDMC Clinical Laboratories routinely offers the HCFA-approved lipid profile (cholesterol, HDL, and triglycerides) on our menu. In addition, BIDMC offers a set of test panels for the convenience of its physician clients. Note that, just as with tests ordered individually, documentation of medical necessity for the test panel is required. All panels offered at BIDMC are described in the subsequent pages of this document.
Ability to order tests individually: Test panels have been created in order to facilitate evaluations and shorten the period of time involved in pursuing laboratory diagnoses. However, any individual test in a test panel may be ordered by itself.
Medical Center approval: This policy on the use of test panels at BIDMC was reviewed and approved by the Core Clinical Services Committee at its January 27, 2009 meeting. In addition, the committee approved any panels offered by our reference lab vendors.
I. Medicare-approved profiles:
The following collection of tests is accepted as medically necessary
by HCFA when ordered for evaluation of the relevant organ or disease, and is
offered at BIDMC.
| Profile name | Test components | Comments |
| Lipid profile (panel) | Cholesterol, HDL cholesterol, triglycerides, (calculated) LDL cholesterol |
The LDL is calculated, at no charge, from the cholesterol, HDL cholesterol and triglycerides. For those samples with triglycerides >400 mg/dL, see Lipid Profile (reflex) under Section II below (Test Panels Specific for Beth Israel Deaconess Medical Center) |
II. Test panels specific for Beth Israel Deaconess
Medical Center:
The laboratories offer
collections of tests to facilitate specific evaluations. Such panels are marked
on laboratory requisitions by their name followed by the descriptor
"panel". The test profiles are defined below. Note that any individual
test in a panel may also be ordered by itself In specific circumstances
described below, the laboratories perform subsequent testing based on the
results of the first test(s) (reflex).
| Profile name | Test components | Comments |
| Albumin/creatinine ratio, urine (aka Microalbumin) (panel) | Urine albumin; urine creatinine; calculated albumin/creatinine ratio (calculation at no charge). Applies to random and timed collections. | Reference: Bennett PH et al: Screening and management of microalbuminuria in patients with diabetes mellitus. Am J Kid Dis 1995; 25: 107-112. Ginsberg JM. Use of single voided urine samples to estimate quantitative proteinuria, NEJM 1983; 309: 15434-1546. |
| All 24-hour urine collections |
Add creatinine to any test requested from a
24-hour collection |
To verify the adequacy of the
collection |
| Antibody screen, red blood cell (reflex) | Initial test screen for red cell antibodies; if present, identification | |
| Antibody titer, red blood cell (panel) | Quantitation of clinically significant antibodies in a pregnant woman to predict severity of hemolytic disease of the newborn; includes interpretation by transfusion medicine specialist | |
| Anti-neutrophil cytoplasmic antibody (ANCA) (panel, reflex) | Antibodies to neutrophil enzymes; specimens with positive or equivocal results tested for anti-myeloperoxidase and anti-proteinase 3 (p29) antibodies | |
| Anti-nuclear antibody screen and titer (ANA) (reflex) | Initial test: ANA screen; if positive, then ANA titer | Quismorio FP: Clinical application of serologic abnormalities in systemic lupus eruthematosis. Chapter 50, in Dubois Lupus Erythematosus, Ed: Wallace & Hahn 5th ed (Williams & Wilkins) 1997). |
| Anti-streptolysin-O antibody evaluation (reflex) | Initial test: Anti-streptolysin-O screen; if positive, then anti-streptolysin-O titer |
| Bartonella antibody (panel) | Bartonella antibody IgG, Bartonella antibody IgM | |
| Bone marrow examination (panel) | Bone marrow aspirate and biopsy examination, including Wright-Giemsa and iron stains; plus CBC and differential if current results not already available in the patient’s record | |
| Borrelia burgdorferi (Lyme) antibody (reflex) | Enzyme immunoassay for IgG /IgM antibodies. If equivocal or positive western blot will be performed as a reflex test. | |
| Chlamydia trachomatis antibody panel (panel) | C. pneumoniae IgG; C. pneumoniae IgM; C. pneumoniae IgA; C. trachomatis IgG; C. trachomatis IgM; C. trachomatis IgA; interpretation | |
| Chromosome analysis, amniotic fluid (panel) | Tissue culture; chromosome analysis; additional karyotyping, cell counts, and/or FISH as indicated. | |
| Chromosome analysis, bone marrow or leukemic peripheral blood (panel) | Tissue culture; chromosome analysis; additional karyotyping, cell counts, and/or FISH as indicated. | |
| Chromosome analysis, chorionic villus (panel) | Tissue culture; chromosome analysis; additional karyotyping, cell counts, and/or FISH as indicated. | |
| Chromosome analysis, cord blood (panel) | Tissue culture; chromosome analysis; additional karyotyping, cell counts, and/or FISH as indicated. | |
| Chromosome analysis, non-leukemic peripheral blood (panel) | Tissue culture; chromosome analysis; additional karyotyping, cell counts, and/or FISH as indicated. | |
| Chromosome analysis, tissue (panel) | Tissue culture; chromosome analysis; additional karyotyping, cell counts, and/or FISH as indicated. | |
| Cold agglutinin evaluation (reflex) | Run a Direct Coombs test [DAT]
first. If negative, no further testing. If positive, cold
agglutinin screen is performed; if positive, perform a cold agglutinin
titer. |
Patients with positive cold agglutinin screens also have a positive DAT. The DAT is a much less labor intensive test and easier to perform. |
| Cryoglobulin panel (aka cold precipitable proteins (panel) | Cryoglobulins; cryofibrinogens | |
| Cryptococcal antigen screen, CSF (reflex) (panel) | Initial test: qualitative test for Cryptococcal antigen; if positive, titration. A culture is also performed on all CSF with orders for Cryptococcal antigen. | |
| Cryptococcal antigen screen, serum (reflex) | Initial test: qualitative test for Cryptococcal antigen; if positive, titration. | |
| Cytomegalovirus early antigen (panel) | CMV early antigen; CMV viral culture | |
| Cytomegalovirus IgG/IgM antibody panel
(panel) |
Cytomegalovirus IgG antibodies;
Cytomegalovirus IgM antibodies |
|
| Direct Coombs test with evaluation
(panel) |
Direct Coombs test; written interpretation of
results by transfusion medicine physician |
|
| Epstein Barr virus antibody panel
(panel) |
Viral capsid antigen, IgG; viral capsid
antigen, IgM; EBV EBNA |
|
| Glucose-6-phosphate dehydrogenase (G6PD)
screen (panel) |
G6PD determination; hemoglobin concentration;
reticulocyte count |
Hemoglobin concentration is necessary to
normalize results. Elevated reticulocyte count may falsely normalize the
G6PD level. |
| Gram Stain, showing gram positive rods
(reflex) |
Initial result: gram positive rods; reflex
Modified Acid Fast Stain for Nocardia AND culture |
Approved at the 6/23/09 CCSC
Meeting |
| HCV Antibody test (reflex) |
Reflex to RIBA for low level
positive samples |
The 2003 CDC guidelines for testing
and reporting antibodies to Hepatitis C Virus recommend that samples with
low level signal to cutoff ratios be confirmed with a second methodology
(RIBA or Viral Load Testing). Our initial experience with our new method (Bayer Centaur, implemented in 2006) confirms that we have a small number of samples in the low positive range (about 0.5% of samples) and that almost half of these samples are negative by RIBA. Given these findings, we believe it to be prudent to reflex to RIBA for all low positive samples. |
| Heavy metal screen, serum
(panel) |
Serum arsenic; serum lead; serum
mercury |
|
| Heavy metal screen, urine
(panel) |
Urine arsenic; urine lead; urine
mercury |
|
| Hemoglobin electrophoresis evaluation
(panel)(reflex) |
Cellulose acetate assay plus CBC with RBC
morphology; if MCV < 80, then HbA2, HbF performed; if abnormal
hemoglobin determined, then confirmation with sickledex or citrate agar
electrophoresis depending on abnormality |
The presence or absence of anemia,
microcytosis, and red cell morphologic changes directs the work-up and
confirms the diagnosis. |
| Hepatitis C Viral Load
(reflex) |
If not detected, will reflex to Hepatitis C
qualitative PCR |
|
| Histoplasma antibodies
(panel) |
Antibody detection by complement fixation,
and by immunodiffusion |
|
| Human immunodeficiency virus 1,2 antibody
(reflex) |
HIV 1 and 2 antibodies by ELISA; if positive,
then confirmed with Western Blot. |
|
| Human leukocyte antigen typing transplant
package (panel) |
HLA class I (A, B, C) alleles; HLA class II
(DR) alleles |
|
| Human T-cell leukemia virus antibody
(reflex) |
Antibodies to HTLV-1/2; if positive, HTLV
Western blot. |
|
| Immunoglobulins, serum
(panel) |
Serum IgG; serum IgA; serum IgM |
Paul ME, Shearer WT: Approach to the
evaluation of the immunodeficient patient, chapter 38, in Clinical
Immunology (Ed Rich) Mosby, 1996. |
| Immunophenotyping (cell surface analysis and
interpretation) (panel) |
Determination of cell surface markers by flow
cytometry; panel of antigens determined in consultation with laboratory
medical director based on clinical indications |
|
| Insulin |
Run a glucose level on every insulin
request. |
A high insulin level, in the face of a low
serum glucose, can cinch the diagnosis of an insulinoma or of unsuspected
administration of exogenous insulin. Unfortunately, what sometimes
happens is that insulin levels are drawn shortly **after** glucose is
administered to relieve a patient's hypoglycemic symptoms. In this
case, the glucose level, which had been low 10 minutes earlier, is now
significantly higher, and the patient's insulin level responds
appropriately by rising. If physicians **assume** that the glucose
level, drawn at approximately the same time (i.e., 10 minutes earlier), is
the same as the glucose level on the sample on which the insulin level is
done, they will be making a serious mistake. The only definitive way
to know the glucose level is to do it on the same sample used for insulin
and to report that glucose along with the insulin level. |
| KOH Smears and Fungal culture except hair, skin and
nails |
KOH and fungal culture |
To increase the sensitivity for detecting fungi in
the sample. The sensitivity of the KOH smear is much lower than
fungal culture |
| Lipid Profile (reflex) |
Cholesterol, HDL cholesterol, triglycerides,
and measured LDL cholesterol |
If a Lipid Profile (Cholesterol, HDL
cholesterol, triglycerides) is ordered, a calculated LDL cholesterol is
expected. For those samples with triglycerides > 400 mg/dL, the
calculation is not valid. Under those circumstances, LDL cholesterol will
be measured (and billed accordingly). In this way, whenever a Lipid
Profile is ordered, the ordering physician will be assured that an LDL
cholesterol will be reported. |
| Lupus anticoagulant screen
(panel)(reflex) |
Initial test: Partial thromboplastin time: If
>4 seconds prolonged, then an inhibitor screen; if results consistent
with inhibitor, then STACLOT-lupus anticoagulant assay; if <4
seconds above upper limit of normal, then PTT-lupus anticoagulant assay,
and if this is abnormal, then STACLOT-lupus anticoagulant
assay |
Ref: Triplett: Thromb Haemost 1993; 70:787;
Triplett: Clin Lab Sci 1997; 10: 223. |
| Multiple Sclerosis (MS)
Profile |
MS PROFILE (Oligoclonal
Bands) IgG INDEX AND SYNTHESIS RATE |
|
| Mycobacterium tuberculosis direct molecular
amplification (Gen Probe) test (panel) |
Direct molecular probe for MTB; plus
mycobacterial culture. |
|
| Narcolepsy Panel |
Perform low resolution typing for
DR/DQ. If either DR2 or DQ6 is identified, high resolution typing
will be performed for each locus. |
|
| Osmotic fragility, red blood cell
(reflex) |
Initial test: Osmotic fragility; if negative,
then osmotic fragility, incubated. |
In some patients the increase in osmotic fragility is only apparent after incubation of red
cells. |
| Parainfluenza antibodies
(panel) |
Antibodies to parainfluenza 1, parainfluenza
2, and parainfluenza 3 |
|
| Parvovirus B19 antibody, IgG and IgM
(panel) |
Parvovirus B19 antibody, IgG; Parvovirus B19
antibody, IgM |
|
| PBG screen (reflex) |
Reflex positives for confirmation
and quantitation by HPLC. |
Our in house method is a screening
assay, and a definitive method is needed to confirm the finding and
quantify the amount. |
| Platelet estimate
(reflex) |
Added by the laboratory when automated
instrument results for platelet count indicate the need for microscopic
confirmation; if smear does not confirm automated count, platelet count by
phase microscopy is performed and reported. |
|
| Postpartum RhoGAM screen
(reflex) |
Qualitative determination of fetal
Rh-positive cells in Rh-negative maternal circulation; if fetal cells
present, Kleihauer-Betke test is performed. |
|
| Prenatal type and screen (panel)
(reflex) |
ABO type, Rh type,antibody screen; if
antibody screen positive, antibody identification is
performed. |
|
| Protein C evaluation
(panel)(reflex) |
Initial test: Functional Protein C
assay. If it is normal/increased, no further tests performed.
If decreased, the comment “warfarin, pregnancy, and hormone
replacement may lower Protein C assay” will be added, and the Protein C
antigen assay performed. |
|
| Protein electrophoresis, serum
(panel)(reflex) |
Initial test: Serum protein electrophoresis
(PEP); if abnormal band questioned, then immunofixation electrophoresis
(IFE) and quantitation of IgG, IgA, and IgM |
|
| Protein electrophoresis, urine
(panel)(reflex) |
Initial test: Urine protein electrophoresis
(PEP); if abnormal band questioned, then immunofixation electrophoresis
(IFE) |
| Protein S evaluation (panel)(reflex) | Initial test: Functional Protein
S assay. If it is normal/increased, no additional tests
performed. If decreased, the comment “warfarin, pregnancy, and
hormone replacement may lower Protein S” will be added, and the
Protein S antigen assay performed. |
|
| Protein/creatinine ratio urine (panel) | Urine protein, urine creatinine; calculated protein/creatinine ratio (calculation at no charge). Applies to random and timed collections. | |
| Quad screen (panel) | Alpha-fetal protein (maternal
screening), human chorionic gonadotropin, inhibin, and unconjugated
estriol |
The four analyte (quad) screen is
preferred to the three analyte (triple) screen as it detects more cases of
fetal Down Syndrome. |
| Red blood cell typing, ABO & Rh (panel) | ABO blood group; Rh blood group | Routine test combination, and mandated by the AABB prior to transfusion (ref Technical Manual, 12th edition, AABB, Bethesda, MD, 1996) |
| Respiratory viral antigen
screen, DFA (panel) |
Direct detection of influenza A
and B, parainfluenza 1, 2 and 3, adenovirus and respiratory syncytial
virus. A viral culture will be set up at the same time. |
|
| Respiratory virus antibody screen
(panel) |
Antibodies to: influenza A and B;
parainfluenza 1,2,and 3; |
|
| RPR evaluation
(reflex) |
Initial test: RPR; if positive,
quantitation and particle agglutination via the Massachusetts Department
of Public Health at no charge to the patient |
|
| Sickle-dex Testing (reflex) |
If this primary screening is positive for Hemoglobin
S, then we need to confirm the presence of Hb S by electrophoresis.
|
This is a regulatory requirement from The College of
American Pathologists. |
| Specific anti-nuclear antibodies
(panel) |
Anti-dsDNA (aka anti-native
DNA); anti Sm+RNP ; anti-Ro + La |
Quismorio FP: Clinical application of serologic abnormalities in systemic lupus eruthematosis. Chapter 50, in Dubois Lupus Erythematosus, Ed: Wallace & Hahn 5th ed (Williams & Wilkins) 1997). |
| Spice Testing
(panel) |
Black pepper
Chili pepper
Cinnamon Curry Dill Ginger Green pepper Mustard Oregano Parsley Thyme Vanilla |
Approved at the 6/23/09 CCSC
Meeting |
| T subset analysis |
Flow cytometric determination of CD4 (% +
absolute), CD8 (% + absolute), and CD3 (% + absolute) counts along with
CD4/CD8 (helper/suppressor) ratio. |
|
| Thyroglobulin |
Run anti-thyroglobulin antibodies
on all thyroglobulin requests. |
Thyroglobulin antibody
measurement is indicated since presence of these antibodies can influence
the thyroglobulin assay results. If anti-thyroglobulin antibodies are
detected, thyroglobulin results should not be trusted, due to possible
interference with the assay. |
| Total B Cells |
CD19 % & Absolute; CD20 % and Absolute; CBC; WBC
DIFFERENTIAL |
Clinicians need absolute counts to monitor Rituxan
therapy. Absolute counts require WBC from CBC and % lymphocytes from
differential to calculate. |
| Total T Cells |
CD 3% and Absolute; CBC; WBC
DIFFERENTIAL |
Clinicians need absolute counts to monitor OKT3 and
ATG therapy |
| Total NK Cells |
CD 56% and Absolute |
Clinicians need both % and absolute counts
reported. Absolute counts are calculated using the WBC from the CBC
and % lymphocytes from the differential. |
| Toxoplasma IgG and IgM antibody panel
(panel) (reflex) |
Toxoplasma antibody, IgG; toxplasma antibody,
IgM If IgM is positive or equivocal on a pregnant woman, reflex confirmation (sendout) will be performed in accordance with FDA guidelines. |
This was in a FDA Public Health Advisory
(7/25/97). “The FDA is advising physicians that they should not use the result from any one Toxo IgM commercial kit as the sole determinate of recent Toxoplasma infection when screening a pregnant patient.” |
| Triple screen
(panel) |
Alpha-fetal protein (maternal
screening), human chorionic gonadotropin, and unconjugated
estriol |
|
| Type and antibody screen
(panel)(reflex) |
ABO blood group; Rh blood group;
antibody screen; if screen positive, then antibody
identification |
"If the antibody screen is positive, the antibody(ies) must be identified. . ." (ref Technical Manual, 12th edition, AABB, Bethesda, MD, 1996) |
| Type and crossmatch
(panel)(reflex) |
ABO type; Rh type; antibody
screen (if positive, then antibody identification);
crossmatch(es) |
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| Urinalysis,
complete (panel)(reflex) |
Dipstick; if dipstick positive
for hemoglobin, leukocyte esterase (to detect WBCs), nitrite (to detect
bacteria), or protein, reflex microscopic sediment exam is
performed. |
Approved by the CCSC Spring 2002. Reference: Wenz B, Lampasso JA: Eliminating unnecessary urine microscopy. Am J Clin Pathol 1989; 92:78-81. |
| von Willebrand’s disease screen
(panel) |
Factor VIII; Vwf antigen; vWF ristocetin
cofactor |
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Urine culture (CVS, catheter, cystoscopy) On prostatic massage urine, a GC culture is added |
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| Suprapubic or Kidney urine culture (anaerobic transport) |
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| Throat culture |
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| Respiratory secretions (sputum/BAL) culture |
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| Legionella culture |
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| Blood culture |
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| Stool culture (Salmonella, Shigella, Campylobacter routinely sought; E. coli 0157-07 routinely on bloody stool, otherwise on request; Vibrio, Yersinia, Plesiomonas, Aeromonas on request only) |
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| Wound (superficial) culture (aerobic swab) |
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| Wound (deep) culture (anaerobic transport) |
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| R/O Group A Streptococcus & Staph aureus (Toxic Shock) (genital) |
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| R/O Group B Strep (anorectal/vaginal) |
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| R/O GC (non-genital sources) |
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| R/O GC (genital source) |
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R/O Chlamydia (genital source) NOTE: rape cases require culture, non-genital sources require culture or DFA |
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| Genital culture |
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| Mycoplasma culture (genital) (urine or swab in transport medium) |
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| Intra-Uterine device (IUD) culture |
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| R/O Bacterial vaginosis (Gardnerella, Mobiluncus, Bacteroides) |
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| Pleural/Peritoneal/Amniotic/Pericardial fluid culture |
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| Synovial fluid culture |
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| CSF culture |
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| Bile culture |
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| Peritoneal dialysis culture |
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| Sterile tissue biopsy culture (e.g. brain, lung, liver,
etc) |
X |
X |
X |
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| Abscess contents/syringe aspirate culture |
X |
X |
X |
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| Nares culture (R/O Staph) |
NA |
X |
NA |
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| Eye culture |
On request |
X |
NA |
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| Ear culture |
On request |
X |
NA |
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| Scalp culture |
On request |
X |
NA |
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| Axilla/Inguinal fold culture (R/O Staph) |
On request |
X |
NA |
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| Bone marrow/Bone marrow harvest |
On request |
X |
On request |
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| Intravenous catheter tip |
NA |
X |
NA |
NOTES:
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| Fungal culture, nail |
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| Fungal culture, other sources |
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| Fungal smear (skin, nails) |
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| Fungal smear (sterile source) |
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| R/O Yeast (genital, oral, stool) |
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| Fungal/AFB blood culture |
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| MYCOBACTERIOLOGY | |||
| TEST ORDERED |
AFB SMEAR |
AFB CULTURE |
FUNGAL
CULTURE |
| AFB/TB culture | X (not routinely done on
urine, bone marrow, stool, or CSF.) On request with approval |
X |
On request |
| AFB/Fungal blood culture | NA |
X |
X |
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| Routine O&P |
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| Giardia/Cryptosporidum Ag |
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| R/O Microsporidium |
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| R/O Cyclospora |
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NOTE: Routine O&P is not likely to detect Cryptosporidium, Microsporidium, or Cyclospora. The Giardia antigen test enhances the sensitivity of detection for Giardia cysts compared to a routine O&P. For detection of Giardia trophozoites, a routine O&P is required.
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TEST ORDERED |
ROUTINE VIRAL CULTURE |
RAPID SHELL VIRAL CMV CULTURE |
DIRECT INFLUENZA A/B |
DIRECT RSV ANTIGEN TEST
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HSV/VZA DFA |
| Viral culture (amniotic fluid, samples from neonates, transplant recipients) |
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| Viral culture (other sources) |
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Direct Influenza A/B(2) |
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| Direct RSV Antigen
Test |
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| HSV/VZV DFA |
On request (collect
appropriate sample) |
X | |||
| Respiratory Viral Antigen Screen
DFA |
X |
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Reviewed/Revised
10/29/2009