Specimen Rejection Criteria for Facility Collected Samples

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Purpose

The Laboratory can provide accurate results only if the specimens provided are fresh, properly obtained, labeled and transported. Specimens must also be from sites appropriate for the test ordered and accompanied by a physician’s order and supporting diagnosis for the testing. On occasion it becomes necessary to reject a specimen. This notice outlines some of the problems that can occur and the Laboratory’s rejection criteria for Facility obtained samples.

Rejection Criteria

There are four basic factors that serve as a foundation for accepting or rejecting specimens:

  1. Specimen labeling and collection problems
  2. Requisitioning difficulties
  3. Specimen integrity problems
  4. Results integrity problems
Blood Collection Problems
  • Clotted samples for whole blood or plasma tests
  • Gross hemolysis
  • IV fluid contamination
  • Incorrect collection tube or container
  • Improperly labeled or unlabeled sample
  • Date and time of collection absent on the order and sample
Urine Collection Problems
  • Urine contaminated with stool
  • Improperly labeled or unlabeled sample
  • Date and time of collection absent on the order or sample
Culture Collection Problems
  • Specimen received damage or leaking
  • Grossly contaminated specimen
  • Improper culture collection materials submitted Improperly labeled or unlabeled sample
  • Date and time of collection absent on the order or sample

When it is necessary for the Laboratory to reject a sample, the Laboratory will notify the Facility of the reason for rejection and request a proper recollection of the sample.

3/5/2020 NICL Laboratories, Ltd All Rights Reserved

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Collection Devices for Chlamydia / GC / Trichomonas by Nucleic Acid Amplification

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FOR GENITAL SPECIMENS

Aptima Unisex Swab Specimens Collection Kit (White Label)

Collection tube with 2 swabs
FEMALE:

Endocervical specimen collected on Aptima Unisex Swab submitted in transport tube. NOTE: Prior to female endocervical specimen collection, excess mucus must be removed with white cleaning swab provided in unisex swab collection kit. Discard white cleaning swab.

MALE:

Urethral swab collected on Aptima Unisex Swab submitted in transport tube. Discard white cleaning swab.

FOR URINE SPECIMENS

Aptima Urine Specimen Collection Kit (Yellow Label)

Aptima Urine Specimen Transport Tube
FEMALE/MALE:
  • The patient should not have urinated for at least one hour prior to specimen collection.
  • Collect first 20 – 30 ml of voided urine (not midstream) in sterile, plastic preservative-free container. Minimum volume is 20ml. Maximum volume 60ml (NOTE: collection of larger volumes may result in dilution which may, in turn, reduce test sensitivity).
  • Transfer approximately 2 ml of urine into the Aptima Urine Specimen transport tube using the disposable pipette provided. Ensure fluid level is between the black lines on the urine specimen transport tube label. Do not overfill or underfill (testing will not be performed if the urine fluid level is not in between the two black lines on the transport tube). Urine specimens must be transferred into the Aptima Urine Specimen transport tube within 24 hours of collection and before being tested.

NOTE: Neisseria gonorrhoeae and chlamydia by nucleic acid amplification and trichomonas vaginalis naa testing are performed on the same Aptima tube and urine replicates are not required. The unisex swab cannot be used for testing males for trichomonas vaginalis. Please submit the urine swab.

NOTE: If other urine tests are requested, they must be submitted in separate plastic containers according to their individual requirements.

9/3/2019 NICL Laboratories, Ltd All Rights Reserved

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Your Patient May NOT Need a Transfusion

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Understanding Postural Pseudoanemia

Simple changes in posture can cause wide fluctuations in hemoglobin (Hgb) and hematocrit (Hct), due to the redistribution of fluid between the intravascular and interstitial spaces. Plasma volume shifts significantly when a person changes position; after a postural change, restoration of equilibrium may take as long as 20 minutes(1). Standing up from a seated or supine position leads to rapid hemoconcentration as gravity causes blood to pool in the lower extremities, causing a hydrostatic shift of plasma fluid into the surrounding tissues. However, variations in lab values also occur with more moderate positional changes, such as going from sitting to a supine position. When a person is lying down, Hgb and Hct values can decrease by approximately 10%, as there is more volume in the intravascular space, leading to an apparent hemodilution. The changes occur in the fluid fraction and not in the red cell mass; therefore, the term postural pseudoanemia is used, as this state does not represent a true pathologic anemia.

A patent’s measured hematocrit may seem to have decreased significantly from a prior value, but this may simply be due to a change in the patient’s position between the two time points of the blood draw. This may alarm the physician, causing them to be concerned for acute anemia. They may then order an unnecessary ancillary tests as well as unnecessary blood transfusions. Therefore, it is important to understand when and how the phlebotomy occurred during each setting in order to better assess the need for a transfusion in a patient based largely on hemoglobin and hematocrit lab values, especially in the absence of other clinical signs or symptoms pointing to a need to transfuse.

Nurses and phlebotomists should aim to standardize patient position before venous blood collection, to minimize spurious lab test results. Because this may not always be possible, patient posture should be stabilized to one position for about 20 minutes before a blood draw. Physicians should take care to consider pre-analytical and other variables when receiving test results that do not match with the patient conditions, and communication between healthcare providers can help mitigate the alarm caused by unexpected laboratory findings.

Nurses and phlebotomists should include the following important parameters in their notes:

  1. Time of day the specimen was drawn
  2. The patient’s position
  3. Any other significant details related to the phlebotomy

References:
(1) Jacob G et al. Postural Pseudoanemia: Posture-Dependent Change in Hematocrit. Mayo Clin Proc. 2005. 80(5):611-614.
(2) Lippi G, et al. Postural change during venous blood collection is a major source of bias in clinical chemistry testing. Clinica Chimica Acta. 2015. 440: 164–168.
(3) Lima-Oliveira G et al. Patient posture for blood collection by venipuncture: recall for standardization after 28 years. Rev Bras Hematol Hemoter. 2017;3 9(2):127–132.

Clinica Chimica Acta. 2015. 440: 164-168
Rev Bras Hematol Hemoter. 2017;3 9(2):127–132

Katsikas 6/14/2018 NICL Laboratories, Ltd All Rights Reserved

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Procalcitonin – for Detection of Severe Infection and Sepsis

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NICL Laboratories is pleased to add Procalcitonin to our in-house esoteric testing menu. This test will be available seven (7) days per week.

Procalcitonin (PCT) is the precursor to calcitonin, and a specific marker for detection of severe bacterial infection and sepsis. Noninfectious inflammations need to be extremely severe for an increase in PCT to occur, making it a better indicator for sepsis than other inflammatory markers, such as cytokines, acute phase reactants, and interleukins. The elevations of PCT are also more sustained than most other markers and will also occur in neutropenic patients. This will reduce false negative results.

PCT begins to rise 2 to 4 hours after onset of severe infection or sepsis and peaks in 12-24 hours. The rise also parallels the severity of the infection/inflammation, as higher levels are found in the more severe infections, and the levels will fall as the inflammation subsides. PCT has a half life of 24-35 hours, making serial testing a useful tool for monitoring the patient’s inflammation or response to therapeutics. As PCT levels will decline as the inflammation subsides, it is also useful for identification of a secondary infection. If serial testing is indicated, the same sample type and testing location are recommended.

It should be noted that the sensitivity and specificity of PCT for sepsis ranges from 60% to 100%, and heterophile antibodies may interfere with all immunometric assays of this sort.

Interpretations

  • In adults, PCT levels less than 0.5 ng/mL represent a low risk of severe sepsis or septic shock, but cannot exclude local infection or systemic infection in early stages of less than 6 hours.
  • PCT levels between 0.2 and 2.0 ng/mL do not exclude an infection, because localized infections without systemic signs may be seen in these situations.
  • PCT levels greater than 2.0 ng/mL are highly suggestive of system bacterial infection or sepsis, or a very severe localized infection such as pneumonia, meningitis, or peritonitis.
  • PCT can also rise in non-infectious situations, such as major burns, severe trauma, acute multi-organ failure or with major abdominal surgery or cardiothoracic surgery, or prolonged or cardiogenic shock, but will generally begin to fall in 24 to 48 hours in these situations.
  • Autoimmune diseases, chronic inflammation, viral infections, and mild localized infections rarely lead to levels greater than 0.5 ng/mL.
  • Renal failure or insufficiency may also influence PCT values, and may confound diagnosis when present.
  • PCT can also be used to differentiate a viral from a bacterial infection.

If there is any disagreement between the laboratory results and the clinical signs, additional testing may be necessary.

5/30/2018 NICL Laboratories, Ltd All Rights Reserved

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Specimen Collection Cups/Devices

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NICL Laboratories provides two types of specimen collection cups/devices:

Complete UA Kit

URINALYSIS and URINE CULTURE AND SENSITIVITY

One device (shown to the left) is a combination collection and transport kit. This kit should be used only for Urinalysis testing and for the preservation of a quality specimen for Culture and Sensitivity. The urine is collected in the sterile blue capped cup and using the integrated transfer device, transferred to red/yellow top tube for urinalysis and if required, the gray top for culture. The transfer to the gray top tube should also be performed if a Urinalysis with Reflex to Culture and Sensitivity is requested. Please remember to properly label all specimens. Specimens transferred into the tubes are stable for 48 hours.

When requesting supplies from the lab, please refer to this device as the Complete UA Kit.

Sterile Cups

STOOL, SPUTUM and URINE CHEMISTRY TESTS

The second specimen collection device is the orange capped sterile cup. This device (shown to the left) should be used for the collection of stool, sputum or urine chemistry tests including urine microalbumin. Please remember to properly label the container.

When requesting supplies from the lab, please refer to this device as Sterile Cups.

10/12/2017 NICL Laboratories, Ltd All Rights Reserved

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Rapid Molecular Testing for Positive Blood Cultures

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NICL Laboratories will be providing new rapid molecular tests to aid in diagnosis of blood stream infections which could lead to sepsis. These new tests, called the Verigene® Blood Culture Nucleic Acid BC-GP or BC-GN, are for detection and identification of gram positive and gram negative organisms, respectively. These tests are also capable of detection of drug resistance markers. The test(s) will be automatically performed when a blood culture becomes positive.

Once a blood culture has been shown to be positive, a gram stain is performed to determine whether the organism is gram positive or gram negative, or if both are present. A sample is then submitted to the Verigene system for BC-GP (Gram Positive) or BC-GN (Gram Negative) organism identification. The results are available in approximately 3 hours. This will reduce the time for identification of the organism and resistance markers for 90% of organisms by nearly two days. The lists below indicate the organisms and resistance markers that can be detected.

Studies have shown that delayed administration of appropriate antibiotics is associated with a decrease in survival rate for each hour that the appropriate antimicrobial treatment is delayed*1. Rapid molecular testing of blood cultures has been shown to reduce this time and is associated with significant institutional cost savings*2.

The laboratory will continue to provide complete susceptibility profiles for blood culture isolates using conventional culture methods, to identify organisms not detected by this method, differentiate mixed culture growth, and to associate antimicrobial resistance marker genes to a specific organism.

*1.Bauer et al.2010. Clin Infect Dis, 51:1074-80

*2.Ly et al. 2008. Clin Risk Manag, 4:637-40

Bacterial Genera, Species and Resistance Markers

GRAM POSITIVE ORGANISMS

Organisms
  • Staphylococcus spp
  • Staphylococcus aureus
  • Staphulococcus epidermidis
  • Stahylococcus lugdunensis
  • Streptococcus spp
  • Streptococcus pneumonia
  • Streptococcus pyogenes
  • Streptococcus agalactiae
  • Streptococcus anginosus group
  • Enterococcus faecalis
  • Enterococcus faecium
  • Listeria spp
Resistance Markers
  • mecA gene, conferring methicillin resistance
  • vanA and vanB genes, conferring vancomycin resistance

GRAM NEGATIVE ORGANISMS

Organisms
  • Acinetobacter spp
  • Citrobacter spp
  • Enterobacter spp
  • Proteus spp
  • Escherichia coli
  • Klebsiella pneumonia
  • Klebsiella oxytoca
  • Pseudomonas aeruginosa
Resistance Markers
  • CTX-M (blaCTX-M)
  • KPC (blaKPC)
  • NDM (blaNDM)
  • VIM (blaVIM)
  • IMP (blaIMP)
  • OXA (blaOXA)

9/8/2017 NICL Laboratories, Ltd All Rights Reserved

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Reticulocyte Hemoglobin Equivalent (Ret-He)

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NICL Laboratories reports a Reticulocyte hemoglobin equivalent (Ret-He) with the Reticulocyte panel, along with the absolute count, percent, and immature recticulocyte fraction.

RET-He measures the hemoglobin content of reticulocytes and is a way of diagnosing and monitoring iron deficiency anemia. Red blood cells have a 120-day lifetime. Detecting iron deficiencies and changes in the iron status of erythropoiesis is only possible relatively late using hematological parameters such as HGB, MCV, MCH, or by reviewing hypochromic red blood cells.

Reticulocytes, the precursors of mature red blood cells, move into the blood stream from the bone marrow and usually mature over the course of about two days. Measuring the number of reticulocytes has been the measure of “quantity” in erythropoiesis in the marrow. Measuring the hemoglobin content of the reticulocytes means that you can also look at the current iron supply to erythropoiesis and judge the “quality” of the cells. It allows you detect changes in iron status far earlier than through the hemoglobin content of mature red blood cells.

There are other conventional biochemical markers for assessing the iron status, such as serum iron, transferrin, or ferritin.   These, however, may be altered during inflammation in the course of an acute phase response, as well as in the presence of many other severe diseases.  This can make a clinical interpretation of the results difficult or impossible.

Low ferritin levels indicate a lack of iron, but normal or elevated levels do not let you draw any conclusions as to the bioavailability of the iron. In the presence of liver damage or chronic diseases such as rheumatoid arthritis, tumors or chronic kidney disease, ferritin can also be elevated in the case of functional iron deficiency. Iron stores can be filled in functional iron deficiency, but the iron is not sufficiently released to the blood flow and therefore not bioavailable for the erythropoiesis. Measuring the hemoglobin content of the reticulocytes as a direct assessment of the iron actually used for the biosynthesis of hemoglobin can indicate whether there is enough iron available for erythropoiesis even in these cases. It is a snapshot of the “quality” of erythropoiesis and is an important tool for diagnosing and monitoring iron deficiency in a matter of days rather than weeks.

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STAT Eligible Testing

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In consideration of the increased acuity of patients now seen in our facilities and in our ongoing efforts to ensure prompt response and quality patient care, NICL Laboratories is providing the following information regarding STAT testing.

By definition, STAT laboratory tests and services are those that are needed immediately in order to manage medical emergencies. STAT test requests are given the highest priority for processing, analysis and reporting. In order to effectively apply resources to meet the needs of genuine medical emergencies, only the test listed below will be offered for STAT priority. All requests for STAT eligible tests must be substantiated by appropriate medical necessity. All results for STAT eligible tests will be called and faxed to the ordering facility. In accordance with Joint Commission requirements the laboratory requires the full name of the individual who receives the STAT test results.

Only the following tests can be ordered STAT:

ChemistryHematology
Basic Metabolic Panel Comprehensive Metabolic Panel Renal Function Panel
BUN
Creatinine
Electrolytes
Glucose
Potassium
Magnesium
Amylase
BNP (B-type natriuretic peptide) Troponin I		CBC w/o differential CBC w/differential
Hemoglobin and Hematocrit Platelets
PT/INR
PTT D-dimer
TherapeuticOther
Digoxin
Dilantin
Phenobarbital
Valproic Acid		Blood Culture (draw only)

Tests not listed as STAT eligible may be scheduled for routine early AM collection. Please contact the laboratory to schedule these collections and have a requisition prepared and/or specimen collected for the phlebotomist’s arrival.

Be advised that facilities requiring same day collection will incur a handling charge. You will be notified of any future modifications to our procedure for STAT services. If you have any questions, please do not hesitate to contact your Customer Service Representative or contact the Laboratory.

6/1/2016 NICL Laboratories, Ltd All Rights Reserved

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Diagnosis of Clostridium Difficile Infection

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Guidelines have emerged to increase the sensitivity of assays for Clostridium difficile (C. difficile).  The primary two guidelines in the U.S. support the use of testing for a common antigen known as glutamate dehyrogenase (GDH) as a primary screen.1,2  GDH has been shown to have sensitivity levels equivalent to molecular methods.  It is produced by non-toxic strains, however, making the testing for the toxin also necessary.

NICL Laboratories will be performing C. difficile testing using an algorithm.  This algorithm will consist of a combination test which includes an Enzyme immunoassay test for the antigen GDH and C. difficile toxin (CDT).  If both tests are negative, the patient will be considered negative for C. difficile Toxin A/B.  If both tests are positive, the patient will be considered positive for C.difficile Toxin A/B. When the results disagree, this combination test will be followed, with a test for the toxin gene using a real-time polymerase chain (PCR) based qualitative test.  The test targets C. difficile Toxin A gene (tcdA), and Toxin B gene (tcdB).  This algorithm appears in teal blue in the chart below.

The laboratory will also be providing a Lactoferrin immunochromatographic assay for detecting the presence of WBCs in stool, to rule out inflammation.   This additional testing, which appears in green in the chart below, will be performed only upon request.

The new test code for C. difficile, including the nucleic acid probe confirmation is 27449.  This testing will continue to be available on a daily basis.  The test code for Lactoferrin for detecting white blood cells in stool is 13630.

NOTE: This testing will only be performed on uniform (liquid or soft) stool specimen.  Solid or hard formed samples will be rejected.

1 Cohen,et al. Clinical Practice Guidelines for Clostridium difficile infection in adults: 2010 update by the Society of Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA).  Infection Control and Hospital Epidemiology. 2010

2American Society for Microbiology. 20103Noren, Torbjorn, Alriksson, Ingegard, Andersson, Josefin, Akerlund, Thomas, Unemo, Magnus   Rapid and Sensitive LoopMediated Isothermal Amp0lification Test for Clostridium difficile Detection Challenges Cytotoxin B Cell Test and Culture as Gold Standard, Journal of Clinical Microbiology, Feb 2011, p 710-711

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