Panel Notification

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This notice contains important information regarding test panels and profiles that you may order from or through NICL.   Please be reminded that you should only order those tests which are medically necessary for the diagnosis and treatment of your patients and that ordering medically unnecessary tests that are billed to Medicare or Medicaid for reimbursement may subject you to civil penalties.  You have the option to order all tests individually.

The table below includes the panel order codes, the individual components, CPT codes[1] and names, and the 2022 Medicare reimbursement rates for currently offered Organ and Disease Panels.

Order Code
CPT Name
CPT[1]		Components Included2022 Medicare Reimbursement
20004Electrolyte Panel80051Sodium Potassium Chloride, Carbon Dioxide$7.01
20167Hepatic Function Panel80076Total Protein, Albumin, Total Bilirubin, Direct Bilirubin, Akaline Phosphatase, AST, ALT$8.17
20163Basic Metabolic Panel80048Glucose, Urea Nitrogen, Creatinine, Sodium, Potassium, Chloride, Carbon Dioxide, Calcium$8.46
20165Renal Function Panel80069Albumin, Calcium, Carbon Dioxide, Chloride, Creatinine, Glucose, Phosphorus, Potassium, Sodium, Urea Nitrogen$8.68
20164Comprehensive Metabolic Panel80053Glucose, Urea Nitrogen, Creatinine, Solium, Potassium, Chloride, Carbon Dioxide, Calcium, Total Protein, Albumin, Total Bilirubin, Alkaline, Phosphatase, AST, ALT$10.56
20062Lipid Panel20062Triglycerides, Total Cholesterol, HDL Cholesterol$13.39
129380Zonisamide (Zonegran®)80203  1
86001  2		Zonisamide
Phoma SPP IGG		$13.25
$7.82
47000Protein Elect. & Total84155  1
84165  1		Protein
Protein Elecrtroph Serum		$3.67
$10.74
71750Immunofixation Eval Serum84155  1
84165  1		Protein
Protein Elecrtroph Serum		$3.67
$10.74
7510Primidone (Mysoline®)80184  1
80188  1		Phenobarbital
Primidone		$15.30
$16.59
2310Alkaline Phosphatase ISO84075  1
84080  1		Alk Phosphatase
Alk Phosphatase, ISO		$5.18
$14.78

[1] The CPT codes and related information provided in the table are based on AMA guidelines and are for informational purposes only.  CPT coding is the sole responsibility of the billing party.  Please direct any questions regarding code to the payer being billed.

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Vancomycin Resistant Enterococci

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Enterococci

  • Enterococci are part of normal gastrointestinal and genital tract flora.
  • Enterococci are gram positive cocci included in the Streptococci group D species; they are widely distributed in nature, animals and humans.
  • Among the 17 species currently recognized, E. faecalis and E. faecium are the most prominent in humans.
  • Infections that can be caused by enterococci include: UTI, bacteremia, wound, abdominal-pelvic infections and endocarditis.
  • Vancomycin is an important antibiotic used alone or in combination with other antibiotics for the treatment of serious infections caused by enterococci.

Resistance to Vancomycin

  • Vancomycin resistant enterococci (VRE) are multidrug resistant strains which present a serious difficulty in treating patients.
  • The resistance to vancomycin is induced by a genetic mechanism; the “VAN A gene” confers high-level resistance to vancomycin; it is plasmid mediated and can be transferred to other microorganisms such as Staphylococcus aureus. This may increase a possible emergence of VRSA (vancomycin resistant Staphylococcus aureus).
  • The patients can be “colonized” (carrying VRE without symptoms of infection), or “infected” (the presence of the VRE accompanied by clinical symptoms). They are both sources for nosocomial infection.
  • The most frequent sites for colonization are: stool, perineal, anus, axilla, umbilicus, wounds, foley catheter, and colostomy sites.

Epidemiology

  • Most infections and colonizations with VRE are attributed to the patient’s endogenous flora.
  • VRE can be spread by direct patient to patient contact or indirectly via hands of personnel, contaminated environmental surface or patient care equipment.

Prevention

  • Since vancomycin use has been reported consistently as a risk factor for colonization and infection with VRE, a restriction in the use of vancomycin should be imposed (see Hospital Infection Control Practices Advisory Committee recommendations).
  • It is strongly recommended for each facility to develop its own policies regarding the prevention and control of nosocomial transmission of VRE (isolation, culture survey, education program) according to the Hospital Infection Control Practices Advisory Committee (a copy is available from NICL).
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Outbreak Protocols

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Outbreaks can happen in any facility, at any time.  We all know that, but when it’s your facility, it can be very stressful.  These are guidelines to help you when you have been told that there is an outbreak in your facility.

(1) Don’t panic!

(2) Give NICL Laboratories a call at (847) 509-9779.  Speak to the Microbiology Supervisor, the Laboratory Technical Operations Manager, or your Customer Service Representative, or send them an email.  NICL Laboratories is experienced with handling outbreaks and can help you and the Public Health Departments to gather the required information.

(3) Have the following information ready:

  • If IDPH (Illinois Department of Public Health) or your local health department has contacted the facility about an outbreak scenario, please provide the Contact Individual’s name to NICL so that we can secure the instructions for the particular outbreak.
  • Patient names and dates of birth
  • Case number assigned

(4) The Health Department may ask you to screen the other patients on the floor where there is an outbreak and/or to screen the employees that take care of the patients on that floor or unit.

(5) As soon as you let us know, we can create our Plan of Action, which may include:

  • Delivering more collection kits
  • Ordering more test kits/materials
  • Change of testing frequency
  • Add testing personnel
  • Coordinate specimens that need to be sent to IDPH, CCPH (Cook County Public Health), other health departments, or even the CDC (Centers for Disease Control)
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HIV Antigen & Antibody COMBO Screen

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The HIV Ag/Ab Combo, 4th generation assay is an in vitro diagnostic immunoassay for the simultaneous qualitative detection of human immunodeficiency virus p24 antigen and antibodies to human immunodeficiency viruses type 1 (including group “O”) and type 2, in serum.  This assay is intended to be used as an aid in the diagnosis of HIV infection in pediatric and adult populations, including pregnant women.  This new assay replaces the current HIV 1/O/2 antibody assay. The current HIV Antibody screen reported by NICL Laboratories reports all of the above except the p24 antigen.   Adding p24 antigen to the screen allows for earlier detection of infection.

Human immunodeficiency virus type 1 has been identified as the primary cause of acquired immunodeficiency syndrome.  This retrovirus, a member of the lentivirinae subfamily, is spread by sexual contact, exposure to infected blood or blood products, and perinatal transmission.  In 1986, human immunodeficiency virus type 2 was isolated from AIDS patients in West Africa.  These viruses share epitopes of the core proteins, but exhibit little or no cross-reactivity between the envelope glycoproteins.

Comparison of the nucleic acid sequences for HIV-1 and HIV-2 shows approximately 60% homology in the conserved genes, such as gag and pol (encoding core proteins), and 30 to 40% homology in less conserved regions (encoding envelope proteins).  HIV-1 has been subdivided into group M (subtypes A-H) and group O.

The route of transmission of HIV-1 and HIV-2 are the same; however, the transmission and the viral replication rate are much lower in HIV-2 infections.  Clinical studies have shown that in HIV-2 infections there is a slower disease progression than in HIV-1 infections.  In HIV-2 infections there is a slower rate in the decline of CD4 T cells and reduced viremia.  Individuals infected with HIV-2 generally have a better clinical outcome.

A reactive result using the Siemens Atellica CHIV assay does not distinguish HIV-1 p24 antigen, HIV-1 antibody, HIV-2 antibody, and HIV-1 group O antibody.  Specimens that are initially reactive should be retested in duplicate.  Repeat reactivity is highly predictive of the presence of antibody to HIV-1 and HIV-2 in specimens from people at risk for HIV infection.  Specimen that show a repeat positive will be followed-up with appropriate supplemental tests for HIV-1 and HIV-2 antibody and/or p24 antigen testing.   NICL Laboratories will reflex a confirmatory test which will also differentiate between HIV-1 and HIV-2.

Reference: Siemens Atellica CHIV instructions for use

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In-Service Lectures

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NICL Laboratories provides scheduled lectures and question-and-answer sessions to clients on  relevant topics, including:

Infection Control Report

  • Facility-specific statistics on infection instances and types
  • Report overview and discussion

Laboratory Results

  • Reporting of Laboratory Values
  • Discussion on handling abnormal laboratory result

Review of the Advanced Standing Order System

  • Laboratory forms and computer printouts
  • Maintenance of the ASOS system/ordering laboratory test(s)
  • Chart Audit and review procedure

Specimen Collection / Infection Control

  • Procedures for collection of specimens for microbiology
  • Optimum times for routine specimen collection
  • Transcaddy specimen collection systems

Bloodborne Pathogens

  • Discussion on OSHA’s Bloodborne Pathogen Standard
  • Exposure Control Plan
  • Identification of potentially infectious items and materials
  • Methods for preventing transmission of disease
  • Universal Precautions

Handwashing for Infection Control

  • Discussion of epidemic transmission of microbes
  • Handwashing indications – CDC Guidelines
  • Handwashing techniques – CDC Guidelines
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Antimicrobial Stewardship and the War on Sepsis

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NICL Laboratories is introducing new technology to Microbiology in May 2022. The new technology is MALDI-TOF or matrix assisted laser desorption/ionization-time of flight, and it will be performed on the Bruker Sirius ONE MALDI Biotyper® CA System.

This technology uses high mass spectrometric resolution to rapidly and accurately identify microorganisms in a matter of minutes after isolation of the organism.

RAPID IDENTIFICATION

Turnaround time for this method is equivalent to a gram stain, but unlike a gram stain it provides definitive identification (ID) of the microorganism with over 98% certainty. The accuracy of this methodology is comparable to nucleic acid sequencing, but it is more cost effective and easily accessible, as it doesn’t require nucleic acid specific testing materials or kits and a longer time to results. If the organism requires specific resistance classification the report will indicate so, and a preliminary identification will be reported, with the organism and resistance reported later.

Included in this method’s compendium are organisms such as Candida auris, a deadly yeast, which is primarily only identifiable via this method. Historically, Candida auris has been transferred to a reference laboratory for identification, adding up to 48 hours to turnaround time.


Blood Cultures and Sepsis

The MBT Sensityper® test will also be available, and when used with the Bruker MALDI Biotyper® allows for identification of the organism directly from a positive blood culture bottle. When the bottle is flagged as positive, this method will allow us to provide a sample for identification on the MALDI in 15 to 20 minutes. This will effectively reduce the turnaround time for organism ID from a blood culture by up to 48 hours.

NICL Laboratories also has a PCR method available for a small menu of organisms, to provide antimicrobial susceptibility test results within a few hours of organism isolation and identification, and it can now be performed in a more selective manner, based upon the organism identified.


Antimicrobial Stewardship

Rapid organism identification from a culture bottle or a culture plate will provide for focused antimicrobial treatment and intervention. Coupled with NICL Laboratories annual MASTR™ report, the Bruker MALDI Biotyper® will assist the Infection Surveillance personnel in appropriate antimicrobial utilization. It will also provide for early determination of contamination, reducing the use of needless treatments.

Use of Broad Spectrum Antimicrobials and intravenous (IV) antimicrobials is very expensive. The use of PIC line and Midline catheters adds to the cost. The cost of use of Daptomycin over the period of a month can cost $9-10,000 and other drugs can cost as much as $33,000 for a one-month Medicare A stay. There is also risk attached to the use of these IV methods as they relate to nosocomial infections.

Use of this technology has an added benefit in that the microtiter wells on the plates used for organism ID can now be used to add a larger menu of antimicrobials for each organism identified, and for some antimicrobials, to provide a greater range of microtiters. BRUKER MALDI Biotyper® will help us to provide you with improved antimicrobial stewardship and patient outcomes.

Sepsis impact on Reimbursement

Hospital Acquired Conditions (HAC) such as sepsis, may impact a facility’s reimbursement. Every year the worst performing 25% are penalized by losing up to 1% of their Medicare payments. Targeted treatment may assist in reducing sepsis, and early successful treatment of other nosocomial infections, which will not only improve patient care and outcome, but it can also significantly impact the financial bottom line.

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D-Dimer

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NICL Laboratories performs D-dimer testing utilizing the INNOVANCE™ D-dimer assay.

The D-Dimer assay is intended for use as an aid in the diagnosis of venous thromboembolism (VTE) [deep vein thrombosis (DVT) or pulmonary embolism (PE)]. Non-elevated levels almost always indicate absence of VTE. Very rarely some patients with distal DVT may yield D-dimer results below the recommended cut-off of 0.50 mg/L FEU. Elevated levels are seen in VTE. However, elevated levels can be caused by other conditions so the results of this test should always be interpreted in conjunction with the patient’s medical history, clinical presentation and other findings.

D-dimer levels may be elevated in advanced age, coronary disease, cancer, hematoma, disseminated intravascular coagulation (DIC), diabetes, stress and hospitalization. D-dimer levels may be decreased in patients on anticoagulant therapy.

The measurement of D-dimer should NOT be used for the diagnosis of VTE in patients with:

  • Sepsis, severe infections, pneumonia, severe skin infections
  • Therapeutic dose anticoagulant therapy for more than 24 hours
  • Fibrinolytic therapy within previous 7 days
  • Trauma or surgery within previous 4 weeks
  • Disseminated malignancies
  • Aortic aneurysm
  • Liver cirrhosis
  • Pregnancy

Decision threshold: As an aid in the diagnosis of VTE (DVT or PE): Less than (<) 0.50 mg/L FEU

Please note that this test’s greatest diagnostic utility is its negative predictive value.

INNOVANCE™ D-Dimer is an immunoturbidometric assay employing a highly sensitive and specific monoclonal antibody for the quantitation of D-dimer in human plasma. It has a broad linear reportable range. The method has a high sensitivity of 97%, specificity of 42% and negative predictive value of 98%. The high sensitivity of the assay assures excellent accuracy and precision of D-dimer results. It has minimal susceptibility to interfering substances, particularly rheumatoid factor, lipemia and bilirubin.

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

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E. Meningoseptica

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Previously known as Flavobacterium meningosepticum, and more recently as Chryseobacterium meningosepticum, Elizabethkingia meningoseptica is a gram-negative bacterium found in soil and water. Although it is rarely isolated from clinical specimens, this organism is resistant to several classes of antimicrobials and is capable of causing infection in blood, cerebrospinal fluid, skin and soft tissue, the respiratory system, and other body sites. Nosocomial transmission of E. meningoseptica among immunocompromised adults in intensive care units has been reported. Further, long-term acute care hospitals with mechanically ventilated patients could serve as an important transmission setting for E. meningoseptica. This multidrug-resistant bacterium could pose additional risk when patients are transferred between long-term acute care facilities and other hospitals.

Please articulate and reinforce your established policies of infection control: handwashing and disinfection practices, isolation policies, the use of gowns and gloves, the proper disposal of body fluids and body fluid– contaminated items, and the use of sterile water for cleaning of respiratory equipment and any other devices that come into contact with mucous membranes or nonintact skin of patients. Additionally, adherence to the current CDC guidelines for prevention of Ventilator-Associated Pneumonia (VAP) is important for reducing these types of infections in the long-term acute care facility.

References:

Weaver, KN et al. Acute Emergence of Elizabethkingia meningoseptica Infection among Mechanically Ventilated Patients in a Long-Term Acute Care Facility. Infection Control and Hospital Epidemiology 2010, Vol. 31 (No. 1), pp. 54-58.

Walkey, AJ et al. Epidemiology of Ventilator-Associated Pneumonia in a Long-Term Acute Care Hospital. Infection Control and Hospital Epidemiology 2009, Vol. 30 (No. 4), pp 319-324.

Tablan OC, et al.; Centers for Disease Control and Prevention (CDC); Healthcare Infection Control Practices Advisory Committee. Guidelines for preventing health-care–associated pneumonia, 2003: recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee. MMWR Recomm Rep 2004; 53(RR-3):1-36.

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

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Therapeutic Monitoring of Vancomycin

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Vancomycin level monitoring is a topic under constant consideration.

Vancomycin trough levels are the preferred test, though Vancomycin peak levels (drawn 3 hours after the dose), may be useful in rare situations when calculation of kinetic parameters are necessary. Vancomycin trough levels should be collected just prior to the 3rd or 4th dose (within 30 minutes prior to administration). Baseline creatinine levels should be measured prior to the start of therapy and weekly during therapy, unless renal function indicates more frequent testing.

Indications for Monitoring

Indications for monitoring include patients with therapy anticipated to be greater than three (3) to five (5) days, infants and children with serious infections, cerebrospinal fluid shunt infections, meningitis, patients with rapid clearance of drug, in selected dialysis patients, and in cases of deteriorating or unstable renal function. In these patients a trough level is recommended, rather than a peak level, as vancomycin is distributed slowly into the peripheral tissues, making it difficult to determine a true peak level.

Therapeutic Ranges

Therapeutic ranges for Vancomycin differ dependent upon the infection.

In those circumstances where levels between 15 and 20 mg/L are indicated, renal function must be monitored closely. The pharmacist should be consulted whenever levels exceed 20 mg/L.

Risk Factors

Risks factors of supratherapeutic dosing (levels over 20 mg/L) are the incremental risks of nephrotoxicity and ototoxicity. Levels below the therapeutic range increase the risk of treatment failure as well as the risk of resistance to the drug.

Reference:
Rybak, Michael, Lomaestro John, Rotschaer, John C, Moellering Jr, Robert, Craig, William, Billeter, Marianne, Dalovisio, Joseph R, Levine, Donald P, Therapeutic monitoring of vancomycin in adult patients: A consensus review of the American Society of Health-System Pharmacists the Infectious Diseases Society of America and the Society of Infectious Diseases Pharmacists. Am J Health Cyst Pharm – Vol. 66 Jan, 2009

3/5/2020 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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