2020

Dear Valued Clients,

On June 4, 2020, the U.S. Department of Health and Human Services (HHS) published new requirements for patient data collection and reporting for COVID-19 test results. 

The following data are required to be collected by all laboratories performing COVID-19 testing:

  • Full Name
  • Date of Birth
  • Gender
  • Race
  • Ethnicity
  • Address including zip code

In addition, the following questions need to be answered at the time of test ordering:

  1. First Test  Yes | No | Unknown
  2. Employed in healthcare? Yes | No | Unknown
  3. Symptomatic as defined by CDC?  Yes | No | Unknown
    • If yes, then Date of Symptom Onset mm/dd/yy
  4. Hospitalized?  Yes | No | Unknown
  5. ICU?  Yes | No | Unknown
  6. Resident in congregate care setting? (including nursing homes, residential care for people with intellectual and development disabilities, psychiatric treatment facilities, group homes, board and care homes, homeless shelter, foster care or other settings) Yes | No | Unknown
  7. Pregnant? Yes | No | Unknown

These new reporting requirements are intended to enhance the ability to monitor disease prevalence and trends by initiating epidemiologic case investigations, and assisting with contact tracing. The new guidance standardizes reporting for public health officials and provides them access to comprehensive and real-time data in their response to COVID-19. 
Clinical Pathology Laboratories (CPL) has modified its paper and electronic COVID-19 test requisitions to comply with these requirements. If you use an EMR to order COVID-19 tests, we will be contacting your office to update the electronic interface to accommodate these requirements. We deeply appreciate your support and cooperation to complete this important effort.

Reporting of these new data elements should begin immediately and we appreciate your assistance in providing this new information with all COVID-10 laboratory orders.

The deadline to comply with these new requirements is August 1, 2020.  

Additional Frequently Asked Questions: 
www.hhs.gov/sites/default/files/laboratory-data-reporting-for-covid-19-testing-faqs.pdf

Complete Report requirement List Available at the link below:
www.hhs.gov/sites/default/files/covid-19-laboratory-data-reporting-guidance.pdf

 

Printable Version

Coronaviruses (CoVs) are a family of enveloped positive-strand RNA viruses that can infect humans and many different species of birds and mammals, including camels, cattle, cats, and bats. The family of viruses can cause respiratory illness ranging from the common cold to more severe respiratory diseases such as Middle East Respiratory Syndrome and Severe Acute Respiratory Syndrome. The most recently identified severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the causative agent of Coronavirus Disease 2019 (COVID-19). Since its emergence at the end of 2019 in Wuhan City, China, the virus has caused an ongoing global outbreak of COVID-19 and a major global public health emergency. The number of patients infected globally by the SARS-CoV-2 virus are increasing rapidly. As of June 24th, 2020, at least 9.24 million confirmed cases and more than 477,000 deaths in over 210 countries are reported. In the US, 123,000 deaths and at least 2.39 million confirmed and presumptive cases of COVID-19 have been reported.

Characteristics of the COVID-19:

  • Transmitted via respiratory droplets similar to influenza virus. 

  • Has an incubation period of 2-14 days following exposure with most showing symptoms in 5 days. 

  • Manifestations range from mild disease with fever, dry cough, shortness of breath, and pulmonary infiltrates to critical illness with respiratory failure, shock, or multi-organ failure.

Methodologies:

Roche COBAS Real-Time RT-PCR: This assay uses the FDA Emergency Use Authorization (EUA) authorized Roche COBAS 2019 Novel Coronavirus (SARS-CoV-2) Real-Time Reverse Transcriptase (RT)-PCR assay intended for the qualitative detection of nucleic acids from SARS-CoV-2 in clinician-instructed self-collected nasal swab specimens (collected on site), and clinician-collected nasal, nasopharyngeal, and oropharyngeal swab specimens from individuals who meet COVID-19 clinical and/or epidemiological criteria. For more information, see:
Fact Sheet for Healthcare Providers: www.fda.gov/media/136047/download
Fact Sheet for Patients: www.fda.gov/media/136048/download  

Roche COBAS Real-Time RT-PCR with specimen pooling: This assay uses the FDA Emergency Use Authorization (EUA) authorized Roche COBAS 2019 Novel Coronavirus (SARS-CoV-2) Real-Time Reverse Transcriptase (RT)-PCR assay. For specimen pooling, the assay is submitted for authorization by FDA under an Emergency Use Authorization (EUA). Negative results should be treated as presumptive and, if inconsistent with clinical signs and symptoms or necessary for patient management, pooled samples should be tested individually. Negative results do not preclude SARS-CoV-2 infection and must not be used as the sole basis for patient management decisions. Negative results must be considered in the context of a patient’s recent exposures, history, presence of clinical signs and symptoms consistent with COVID-19. For more information, see:
Fact Sheet for Healthcare Providers: www.fda.gov/media/136047/download 
Fact Sheet for Patients: www.fda.gov/media/136048/download

Thermo-Fisher Real-Time RT-PCR: This assay uses the FDA Emergency Use Authorization (EUA) authorized Thermo Fisher TaqPath COVID-19 Real-Time Reverse Transcriptase (RT)-PCR Diagnostic intended for the qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens (such as nasopharyngeal, oropharyngeal, nasal, and mid-turbinate swabs, and nasopharyngeal aspirate) and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider. For more information, see:
Fact Sheet for Healthcare Providers: www.fda.gov/media/136111/download   
Fact Sheet for Patients: www.fda.gov/media/136114/download

Transcription-Mediated Amplification (TMA): This assay uses the FDA Emergency Use Authorization (EUA) authorized Hologic Aptima SARS-CoV-2 Transcription Mediated Amplification and Dual Kinetic Assay.  It is a nucleic acid amplification test intended for the qualitative detection of RNA from SARS-CoV-2 isolated and purified from nasopharyngeal (NP), nasal, mid-turbinate and oropharyngeal (OP) swab specimens, nasopharyngeal wash/aspirate or nasal aspirates obtained from individuals meeting COVID-19 clinical and/or epidemiological criteria. intended for the qualitative detection of nucleic acids from SARS-CoV-2 in clinician-instructed self-collected nasal swab specimens (collected on site), and clinician-collected nasal, nasopharyngeal, and oropharyngeal swab specimens from individuals who meet COVID-19 clinical and/or epidemiological criteria. For more information, see:
Fact Sheet for Healthcare Providers: www.fda.gov/media/138095/download
Fact Sheet for Patients: www.fda.gov/media/138098/download

CDC’s clinical criteria for COVID-19 testing is frequently updated as additional information becomes available. The most recent information on COVID-19 can be found at: www.cdc.gov/coronavirus/2019-ncov/downloads/priority-testing-patients.pdf. CDC currently provides guidance for testing in five categories with the most recent information found below:

  • Testing individuals with signs or symptoms consistent with COVID-19.
  • Testing asymptomatic individuals with recent known or suspected exposure to SARS-CoV-2 to control transmission.
  • Testing asymptomatic individuals without known or suspected exposure to SARS-CoV-2 for early identification in special settings.
  • Testing to determine resolution of infection (i.e., test-based strategy for Discontinuation of Transmission-based Precautions, HCP Return to Work, and Discontinuation of Home Isolation).
  • Public health surveillance for SARS-CoV-2.

 

Test Information

Test Code / Name:

7305 SARS-COV-2 BY NUCLEIC ACID AMPLIFICATION (NAAT)

Important Information:

All specimens must be accompanied by demographic information to include address with zip code, race and ethnicity. This is required by the CARES Act and federal regulation and is requested by state and local health authorities for public health and contact tracing purposes. In addition, limited clinical data are requested for testing. The clinical data are used for epidemiology and public health purposes. These may be used by the laboratory to determine testing priority and suitability for pooled analysis. Contact your account representative for further information on prioritization of testing.

COVID-19 Requisition: www.cpllabs.com/COVID19_Req

COVID-19 History Form: www.cpllabs.com/COVID19_History_Form

The source must be clearly indicated on the specimen and test requisition.

 

Specimen Requirements 

Preferred Sample:
  • Upper Respiratory Tract: Nasopharyngeal, oropharyngeal, nasal mid-turbinate or anterior nares swabs
Acceptable Sample:
  • Nasopharyngeal wash/aspirate 
  • Lower Respiratory Tract
    -    Sputum
    -    Bronchoalveolar Lavage OR Tracheal Aspirate
Container Type:

Nasopharyngeal swabs: Viral or Universal Transport Media (VTM-M4, VTM-M4RT, UTM-RT, BD UTV, Puritan UniTranz-RT (UT-100), Sonic VTM), ESwab (white, blue or green top), nuclease free water or glass sterile saline tube inside U50 with swab(s) in collection container.

Sputum: Sterile cup.

Bronchoalveolar lavage/tracheal aspirate: Sterile cup.

For initial diagnostic testing for COVID-19, CDC recommends collecting an upper respiratory tract specimen.

Collection Instructions:

Nasopharyngeal Swab:

Tilt patient’s head back 70 degrees and insert swab into nostril parallel to palate. (Swab should reach depth equal to distance from nostrils to outer opening of the ear). Leave swab in place for several  seconds to absorb secretions. Slowly remove swab while rotating it. Place tip of swab into the transport media and snap off the applicator stick. Ensure cap is properly sealed and refrigerate (critical). 

NOTE: Do not use calcium alginate swabs or swabs with wooden shafts, as they may contain substances that inactivate some viruses and inhibit PCR testing. For further instructions with graphics, see URL: 
www.cpllabs.com/COVID19_Nasal_Collection

Other specimens:
Oropharyngeal (OP) swab:
collected by a healthcare professional
Nasal mid-turbinate swab: collected by healthcare professional or onsite self-collection
Anterior nare swab: collected by healthcare professional or onsite self-collection

Sputum:

Have the patient rinse the mouth with water and then expectorate deep cough sputum directly into a sterile, leak-proof, screw-cap sputum collection cup or sterile dry container. Do not induce sputum

Bronchoalveolar Lavage, Tracheal Aspirate:

Collect 2-3 mL into a sterile, leak-proof, screw-cap sputum collection cup or sterile dry container.

All specimens should be refrigerated at 2-8°C and shipped overnight on ice pack. If specimen will not reach the laboratory within 72 hours of collection (48 hours for ESwab collection devices), freeze and ship on dry ice.

Transport Temperature:

Critical Refrigerate

Specimen Stability:

Refrigerated: 72 Hours (48 Hours for ESwab collection systems)

Frozen (-20°C or below): 1 Week

Rejection Criteria:

Room temperature specimens, swabs not in viral transport media, calcium alginate swabs and swabs with wooden shafts WILL NOT be accepted.

 

Testing

Expected Turn Around:

1 - 5 Days (NOTE: High Risk testing takes priority and may impact TAT accordingly)

Testing Frequency:

Daily
CPT:

87635 (NOTE: CPT for Medicare is U0003)

Methodology:

Real-Time Polymerase Chain Reaction (RT-PCR) OR 
Real-Time Polymerase Chain Reaction (RT-PCR) with specimen pooling OR Transcription Mediated Amplification (TMA).  See report for method.

COMPLIANCE STATEMENT: The SARS-CoV-2 test is intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal and oropharyngeal swab samples from patients who meet COVID-19 clinical and/or epidemiological criteria. For lower respiratory tract specimens, the assay is submitted for authorization by FDA under an Emergency Use Authorization (EUA). Testing methodology is nucleic acid amplification technology (NAAT) by real-time RT-PCR or transcription mediated amplification (TMA). The methodology employed is noted in the analysis report. If received as separate collection devices, nasopharyngeal and oropharyngeal specimens are combined for analysis. Additional specimens may be split to a separate accession for analysis and reporting as this test includes a single unit of service.

Test results must be correlated with clinical presentation and evaluated in the context of other laboratory and epidemiologic data. Test performance can be affected because the epidemiology and clinical spectrum of infection caused by SARS-CoV-2 is not fully known. For example, the optimum types of specimens to collect and when during the course of infection these specimens are most likely to contain detectable viral RNA may not be known.

The real-time RT-PCR and TMA tests have not been Food and Drug Administration (FDA) cleared but have been authorized by FDA under an Emergency Use Authorization (EUA). The tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of SARS-CoV-2 under Section 564(b)(1) of the Act, 21 U.S.C. section 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Clinical Pathology Laboratories are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. section 263a, to perform high complexity tests.

 

COVID-19 Specimen Transport Media and Swabs

Printable Version

CDC PUI Form

Effective June 1st, 2020, Clinical Pathology Laboratories will implement the BioRad BioPlex Multiplex Flow Immunoassay to replace traditional ELISA methodology for the following disease state antibody profiles:

  • Antiphospholipid antibody syndrome (APS) or lupus anticoagulant
    • Cardiolipin IgA, IgG and IgM Antibody
    • Beta-2 Glycoprotein 1 IgG and IgM Antibody
  • Celiac disease or gluten-sensitive enteropathy
    • Deamidated Gliadin Peptide (DGP) IgA and IgG Antibody

    • Tissue Transglutaminase (tTG) IgA and IgG Antibody

  • Vasculitis (Wegener granulomatosis, microscopic polyangiitis, Churg-Strauss, others)
    • Myeloperoxidase (MPO) Antibody
    • Serine Proteinase 3 (PR3) Antibody
  • Rheumatoid arthritis
    • Cyclic Citrullinated Peptide (CCP) Antibody

The Multiplex Flow Immunoassay comprises collections of polystyrene bead populations distinguished from one another by fluorescence spectra and covalently bound antigen analyzed in a flow cytometry-like detector. This permits simultaneous analysis of multiple antibodies or biomolecules with higher precision and reproducibility than earlier ELISA technology. Aside from distinct units of measure and different cutoffs, the method offers simplified interpretations of Negative or Positive in addition to the raw index values to replace prior interpretations of Indeterminate, Weak Positive, Strong Positive, etc. All assays show the following stability: room temperature 1 day; refrigeration 1 week; frozen 1 month. Additional notes by disease state are given below:

  • Antiphospholipid antibody syndrome (APS):
    • Meets criteria set for test performance in Antiphospholipid Antibody testing as expressed in Eleventh International Congress on antiphospholipid antibodies (Sydney APS Laboratory Testing Criteria).
    • To achieve optimal specificity, antibody cutoff is set at 95-99th percentile of normal controls.
  • Celiac disease or gluten-sensitive enteropathy
    • Clinical sensitivity/specificity for celiac disease:
      • tTG IgA: 94.3% sensitive/98.8% specific; DGP IgA: 86.6% sensitive/96.9% specific.
      • tTG IgG 44.6% sensitive/95.7% specific; DGP IgG 84.7% sensitive/96.9% specific.
      • tTG IgA antibodies correlate closely with the activity of disease and are useful for diet monitoring.
      • IgG antibodies are more useful and informative in patients with selective IgA deficiency. Consider reflex testing (IgA reflex to celiac antibodies; unit code 4739).
  • Vasculitis (Wegener granulomatosis, microscopic polyangiitis, Churg-Strauss, others)
    • MPO shows 95% overall agreement with a prior ELISA method and 93.3% positive agreement with pANCA pattern on indirect immunofluorescence assay (IFA).
    • PR3 shows 95% agreement with prior ELISA and 95% positive agreement with cANCA pattern on IFA.
  • Rheumatoid arthritis
    • CCP antibody: 83.1% sensitive (known RA patients), 97.8% specific.
    • With higher specificity than typically seen with rheumatoid factor (RF) assays, positive CCP antibody results are associated with a higher positive predictive value (PPV) for rheumatoid arthritis.

Assay report details are given below:

Test(s) Order Code

CPT Code

Ref. Range, UnitsInterpretation
Cardiolipin IgA Antibody
Cardiolipin IgG Antibody
Cardiolipin IgM Antibody
Beta-2 Glycoprotein 1 IgG Antibody
Beta-2 Glycoprotein 1 IgM Antibody
4793
4791
4792
3416
3417
86147
86147
86147
86146
86146
<20 APL-U/mL
<20 GPL-U/mL
<20 MPL-U/mL
<20 U/mL
<20 U/mL
Negative/Positive
Negative/Positive
Negative/Positive
Negative/Positive
Negative/Positive
DGP IgA Antibody
DGP IgG Antibody
tTG IgA Antibody
tTG IgG Antibody
4719
4718
4725
4720
83516
83516
83516
83516
<15 U/mL
<15 U/mL
<15 U/mL
<15 U/mL
Negative/Positive
Negative/Positive
Negative/Positive
Negative/Positive
MPO Antibody
PR3 Antibody
4965
4967
83516
83516
<1.0 AI
<1.0 AI
Negative/Positive
Negative/Positive
CCP Antibody539086200<3.0 U/mLNegative/Positive

Additional Test Information:

Order Codes:See table above
Specimen Requirements:0.5 mL serum from SST
Transport Temperature:Refrigerated
Stability (collection to initiation of testing):24 hours Room Temperature; 7 days Refrigerated; 1 month Frozen
Performed:Monday through Friday; PM Shift
Analytic Time:1 Day
Specimen Retention:7 Days
CPT Codes:See table above

 

Printable Version

Effective May 11, 2020, Clinical Pathology Laboratories (CPL) will offer SARS-CoV-2 total antibody assay using the Roche COBAS Electrochemiluminescence Immunoassay (ECLIA) method. The immunoassay is designed to detect IgG, IgA and IgM antibodies to recombinant nucleocapsid protein of SARS-CoV-2 in serum intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown how long antibodies persist following infection and if the presence of antibodies confers protective immunity. It is important to note that negative results do not rule out acute SARS-CoV-2 infection, particularly in those who have been in recent contact with the virus. Testing with a nucleic acid amplification test (NAAT; RT-PCR, TMA, others) should be considered to evaluate for active infection in these individuals. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.

This test has not been Food and Drug Administration (FDA) cleared or approved but has been authorized by FDA under an Emergency Use Authorization (EUA). This test has been authorized only for the detection of antibodies against SARS-CoV-2, not for any other viruses or pathogens. The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of SARS-CoV-2 under Section 564(d)(1) of the Act, 21 U.S.C. section 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Clinical Pathology Laboratories is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. section 263a, to perform high complexity tests. This assay is not for the screening of donated blood.

Fact Sheet for Healthcare Providers: www.cpllabs.com/COVID19_TotalAntibody_FactSheet_HealthcareProvider

Fact Sheet for Patients: www.cpllabs.com/COVID19_TotalAntibody_FactSheet_Patient

Please contact your Account Representative should you have any questions.

TEST INFORMATION:
Test Code / Name:7304   Anti-SARS-CoV-2 
SPECIMEN REQUIREMENTS:
Preferred Sample:

2 mL serum from SST

Allow SST to clot in an upright position for at least 30 minutes, then centrifuge sample within 2 hours of collection. Refrigerate.

For phlebotomy service to a recently symptomatic patient, please have patient present at least 3 days beyond end of symptoms, at least 10 days from symptom onset for phlebotomy.  

Please instruct all patients ordered for COVID-19 antibody to wear a facemask for phlebotomy.

Acceptable Sample:

2 mL serum from a plain red top tube

Allow sample to clot in an upright position for at least 60 minutes, then centrifuge sample and transfer serum to a plastic transport tube within 2 hours of collection. Clearly label tube as serum from a plain red top tube.

Transport Temperature:Refrigerated
Specimen Stability:3 Days Room Temperature; 7 Days Refrigerated; 28 Days Frozen
Rejection Criteria:1 freeze/thaw cycle or heat inactivated serum
TESTING:
Expected Turn Around: 3 Days
Testing Frequency:Monday through Friday
CPT:86769
Methodology:   Electrochemiluminescence Immunoassay (ECLIA)

 

Printable Version

 

The U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), launched a new COVID-19 Uninsured Program Portal, allowing health care providers who have conducted COVID-19 testing or provided treatment for uninsured COVID-19 individuals on or after February 4, 2020 to submit claims for reimbursement.

Clinical Pathology Laboratories (CPL) will file claims to any third party payer. Please include patient demographics and insurance information as applicable. If you have determined that the patient is uninsured, CPL will file the appropriate claim when the following information is received:

  • Patient name, date of birth, gender and address.
  • Patient Social Security Number and/or Driver’s License Number (and issuing state).

HRSA will cover ALL COVID testing sent to CPL including:

CPL Test CodeTest NameCPT Code
7300, 7305, 7581COVID-19 PCRU0003 or 87635 or U0002
7301SARS-CoV-2 IgG86769
7304SARS-CoV-2 Abs, Total86769

If ordering in Atlas on an uninsured patient, place the order as Insurance Bill.

  1. Select COVID-19 HRSA Uninsured Testing and Treatment Fund as the insurance type.
  2. Enter patients Driver’s License Number in as the Policy Number.
  3. Enter the two-letter state abbreviation as the Group Number.
  4. If the patient does not have a Driver’s License, place their Social Security Number as the Policy Number.
  5. For patients who confirm that they are uninsured but do not have a Driver’s License and do not want to give their Social Security Number, enter 999999 as the Policy Number.

For testing to be eligible for reimbursement by HRSA, claims submitted must include one of the following Diagnosis Codes:

Diagnosis CodeDescription
Z03.818Encounter for observation for suspected exposure to other biological agents ruled out (possible exposure to COVID-19)
Z20.828Contact with and (suspected) exposure to other viral communicable (confirmed exposure to COVID-19)
Z11.59Encounter for screening for other viral diseases (asymptomatic)

Please contact your Account Representative should you have any questions.

Printable Version

 

Effective April 28, 2020, Clinical Pathology Laboratories (CPL) will offer IgG serology for SARS-CoV-2, the causative agent of COVID-19 clinical illness. The Abbott Architect chemiluminescent microparticle immunoassay (CMIA) is designed to detect IgG antibodies to the nucleocapsid protein of SARS-CoV-2 in serum from patients who have signs and symptoms of infection, are suspected of coronavirus disease (COVID-19) or have been infected by SARS-CoV-2. It is important to note that negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Testing with a nucleic acid amplification test (NAAT; RT-PCR, TMA, others) should be considered to evaluate for active infection in these individuals. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.

This test has not been Food and Drug Administration (FDA) cleared or approved but has been authorized by FDA under an Emergency Use Authorization (EUA). This test has been authorized only for the detection of IgG antibodies against SARS-CoV-2 and not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of In-Vitro Diagnostic tests for detection and/or diagnosis of SARS-CoV-2 under Section 564(d)(1) of the Act, 21 U.S.C. section 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Clinical Pathology Laboratories is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. section 263a, to perform high complexity tests. This assay is not for the screening of donated blood.

Fact Sheet for Healthcare Providers: www.cpllabs.com/COVID19_IgGAssay_FactSheet_HealthcareProvider

Fact Sheet for Patients: www.cpllabs.com/COVID19_IgGAssay_FactSheet_Patient

Please contact your Account Representative should you have any questions.

 

TEST INFORMATION:
Test Code / Name:7301   SARS-CoV-2 IgG
SPECIMEN REQUIREMENTS:
Preferred Sample:

2 mL serum from SST

Allow SST to clot in an upright position for at least 30 minutes, then centrifuge sample within 2 hours of collection. Refrigerate.

For phlebotomy service to a recently symptomatic patient, please have patient present at least 3 days beyond end of symptoms, at least 7 days from symptom onset for phlebotomy.

Please instruct all patients ordered for COVID-19 antibody to wear a facemask for phlebotomy.

Acceptable Sample:

2 mL serum from a plain red top tube

Allow sample to clot in an upright position for at least 60 minutes, then centrifuge sample and transfer serum to a plastic transport tube within 2 hours of collection. Clearly label tube as serum from a plain red top tube.

Transport Temperature:Refrigerated
Specimen Stability:2 Days Room Temperature; 7 Days Refrigerated; 1 Month Frozen
Rejection Criteria:2 freeze/thaw cycles, heat inactivated specimens, pooled specimens, grossly hemolyzed specimens, obvious microbial contamination specimens.
TESTING:
Expected Turn Around: 2 Days
Testing Frequency:Monday through Friday
CPT:86769
Methodology:   Chemiluminescent Microparticle Immunoassy (CMIA) 

 

Printable Version

Sonic Healthcare USA Announces Testing Availability for COVID-19

 

Austin, Texas March 13th, 2020

 

Sonic Healthcare USA has worked closely with its scientific partners and medical and operational leadership to bring up testing to ensure timely availability for patients in all geographies served by our laboratories. "We are closely monitoring capacity and are coordinating with our clinical laboratories to distribute testing that mitigates high demands from endemic regions and clusters in the United States," said Jerry Hussong, MD, MBA, the Chief Executive Officer of Sonic Healthcare USA.

Sonic has taken comprehensive measures to expand testing capacity, while maintaining high quality testing and meeting required turnaround times. As a result, Sonic is bringing up multiple testing platforms and methodologies.

Dr. Hussong added, "In response to this public health emergency, Sonic Healthcare USA pledges to do its part and is actively monitoring the situation. Our commitment is to ensure testing is available as this pandemic evolves." The well-being of our patients and employees is our highest priority, and we continue to be committed to the medical communities we serve.

 

About Sonic Healthcare USA

Sonic Healthcare USA is a subsidiary of Sonic Healthcare Limited, one of the world's largest medical diagnostic companies, providing laboratory services to medical practitioners, hospitals and community health services, with operations in eight countries, on three continents and providing care to over 100 million patients each year. Sonic Healthcare USA is a leading provider of state-of-the-art laboratory services and pathology practices throughout the USA with nine operating divisions and nearly eight thousand US-based employees. Sonic Healthcare USA utilizes a federated business model that emphasizes medical leadership and community-based testing services to provide outstanding quality and service to the doctors and patients that they serve. For more information, visit the Sonic Healthcare website at www.sonichealthcareusa.com.

 

Sonic Healthcare USA Media Contact

Chief Executive Officer
Dr. Jerry Hussong, MD, MBA
jhussong@sonichealthcareusa.com 
512.531.2216

The information provided below is current as of March 9, 2020.

 

Under the guidance of the US Centers for Disease Control and Prevention (CDC), Sonic Healthcare USA (SHUSA) laboratories are closely monitoring the Coronavirus 2019 (COVID-19) outbreak caused by SARS-CoV-2. To date, over 100,000 human infections have been confirmed, and almost 4,000 patients have died.

 

Affected Geographic Areas with Widespread or Sustained Community Transmission:

 

  • China
  • Iran

  • Italy

  • Japan

  • South Korea

 

Imported cases have been identified in the U.S. According to the CDC:

 

  • Some international destinations now have apparent community spread with the virus that causes COVID-19, as do some parts of the United States. Community spread means some people have been infected and it is not known how or where they became exposed.   
  • The virus is thought to spread mainly from person-to-person.
    • Between people who are in close contact with one another (within about 6 feet).
    • Through respiratory droplets produced when an infected person coughs or sneezes.
  • No vaccine or specific treatment for COVID-19 is currently available. 
  • Care is supportive.

 

Interim Guidance from the CDC for Healthcare Providers:

 

  • Infection control procedures are necessary to prevent infections from spreading during healthcare delivery. COVID-19 Infection Control recommendations provided by the CDC may be accessed at: https://www.cdc.gov/coronavirus/2019-nCoV/hcp/infection-control.html
  • For initial diagnostic testing for SARS-CoV-2, CDC recommends collecting and testing upper respiratory tract specimens (nasopharyngeal AND oropharyngeal swabs). 
  • In considering whether a patient represents a person under investigation (PUI) for COVID-19, healthcare providers should immediately notify infection control personnel at their healthcare facility and their local or state health department. Use links below:
  • Laboratory testing for other pathogens from PUIs (including testing for influenza, RSV, respiratory pathogen panel, etc.) should not be delayed. In order to provide adequate infection control, please notify Clinical Pathology Laboratories in advance of sending specimens from a PUI for COVID-19. A separate specimen(s) will be required.

 

Criteria to Guide Evaluation of Patients Under Investigation (PUI) for COVID-19

  • As the availability of diagnostic testing for COVID-19 increases through clinical laboratories performing molecular diagnostic (nucleic acid-amplification tests) tests authorized by the US FDA under an Emergency Use Authorization (EUA), testing will be offered to a wider group of symptomatic patients. 
  • Clinicians should use their judgment to determine if a patient has signs and symptoms compatible with COVID-19 and whether the patient should be tested. Decisions on which patients receive testing should be based on the local epidemiology of COVID-19, as well as the clinical course of illness. Most patients with confirmed COVID-19 have developed a fever and/or symptoms of acute respiratory illness (e.g., cough, difficulty breathing). Clinicians are strongly encouraged to test for other causes of respiratory illness, including infections such as influenza.
  • Epidemiologic factors that may help guide decisions on whether to test include: any persons, including healthcare workers, who have had close contact with a laboratory-confirmed COVID-19 patient within 14 days of symptom onset, or a history of travel from a geographic area with the ongoing transmission (see list above) within 14 days of symptom onset.
  • State and local health authorities may assist or guide clinicians in PUI identification, evaluation, and testing.  
  • Clinicians will also be able to access laboratory testing through public health laboratories in their jurisdictions.

   

For additional information, please use links given below:

 

The COVID-19 outbreak is rapidly evolving, and we will continue to monitor the situation and update you as new information becomes available.

 

- Pathologist Executive Leadership Council, Sonic Healthcare USA

Austin, Texas  March 6th, 2020

This week, Academic and Commercial Reference Laboratory Executives met with Vice President, Mike Pence and members of the White House's Coronavirus Task Force to collectively discuss diagnostic testing availability for COVID-19. 

Jerry Hussong, MD, MBA, the Chief Executive Officer of Sonic Healthcare USA (Sonic), was among those who met on behalf of the American Clinical Laboratory Association (ACLA) with key government officials, the CDC, and the FDA.  At the meeting, key stakeholders discussed the role of state and local public health and commercial laboratories, hospitals, and academic medical centers to increase access to testing for the Coronavirus.  "Our main goal, as a commercial laboratory, is to ensure those patients in need or at high-risk can access testing. By working together, we can accelerate those efforts with a coordinated and comprehensive approach," said Dr. Hussong.

Dr. Hussong added, "Sonic Healthcare is working with its Medical, Scientific and Operational Leadership to make patient testing available through its network of commercial laboratories in the United States and will follow the FDA guidelines for Emergency Use Authorizations (EUAs)."  The FDA has recently updated its policy, thus providing an expedited pathway for the availability of diagnostics for COVID-19.

Sonic Healthcare will continue to lead and collaborate with colleagues, government officials, and our local medical communities in response to this immediate public health crisis.

Read the ACLA Statement on COVID-19 Testing

 

About Sonic Healthcare USA

Sonic Healthcare USA is a subsidiary of Sonic Healthcare Limited, one of the world's largest medical diagnostic companies, providing laboratory services to medical practitioners, hospitals and community health services, with operations in eight countries, on three continents and providing care to over 100 million patients each year. Sonic Healthcare USA is a leading provider of state-of-the-art laboratory services and pathology practices throughout the USA with nine operating divisions and nearly eight thousand US-based employees. Sonic Healthcare USA utilizes a federated business model that emphasizes medical leadership and community-based testing services to provide outstanding quality and service to the doctors and patients that they serve. For more information, visit the Sonic Healthcare website at www.sonichealthcareusa.com.

 

Sonic Healthcare USA Media Contact

Chief Executive Officer
Dr. Jerry Hussong, MD, MBA
jhussong@sonichealthcareusa.com 
512.531.2216

Effective March 16, 2020, Clinical Pathology Laboratories (CPL) will update reference ranges for the complete blood cell (CBC) count. This is the first of several planned CBC updates.

The new adult reference ranges reflect a Sonic Healthcare USA consensus which align with those of other large reference laboratories and hospital systems. The pediatric reference ranges align with those published by the American Association for Clinical Chemistry [Pediatric Reference Intervals, 7th Ed. (2011)] using similar Sysmex technology and a large pediatric population. In aggregate the new reference ranges are not expected to significantly shift the percentage of patients flagged as having abnormal values, however clinicians may see a shift of up to 5% in the number of patients with abnormal results for select components such as hemoglobin.

Over the course of the year, CPL will make additional changes to CBC reporting to more closely align with widely accepted laboratory standards. These include the following changes (implemented in the order listed):

  • Reporting absolute WBC counts (e.g., absolute neutrophil count, absolute lymphocyte count, etc.) with appropriate reference ranges, in addition to the relative percentage WBC differential for all unit codes. This change will also include reporting absolute immature granulocyte count (IG#) in addition to the relative immature granulocyte percentage (IG%).

Under most circumstances, clinically relevant WBC elevations and declines are defined by absolute counts, not by relative percentages. Current recommendations from the College of American Pathologists (CAP) and the Clinical and Laboratory Standards Institute (CLSI), recommend that absolute counts be the preferred method for reporting the WBC differential.

  • Discontinuing reporting of reference ranges for relative WBC differentials as they are superfluous.
  • Retiring unit codes 1011, 1014, 1016, 1017 (these orderable codes currently provide absolute WBC counts for subsets of the WBC differential and will become redundant).

As a reminder, with the latest CBC instrumentation, automated WBC differentials are superior to manual WBC differentials in terms of accuracy, precision, turn-around-time, and clinical sensitivity in distinguishing normal from abnormal samples. The instruments have complex flagging systems that alert technologists to abnormal morphology that requires a manual slide review and replacement of the automated differential with a manual differential. After slide review, the technologist will note if criteria are met for pathologist slide review.

Please contact your Account Representative should you have any questions regarding the changes described above.

 

ORDER UNIT CODES: 1000, 1001, 1005, 1007, 1010, 1011, 1013, 1014, 1015, 1016, 1017, 1025, 1030, 1041, 1045, 1047, 1050, 1051, 1365

 

Download Full List of CBC Count the Reference Ranges

 

Effective March 16, 2020, Clinical Pathology Laboratories will implement a new DiaSorin LIAISON® Chemiluminescent immunoassay for Borrelia burgdorferi (Lyme Disease) to replace the Immunetics ELISA method. The LIAISON® assay format includes the entire VIsE (the variable major protein-like sequence surface protein) antigen complex in a reagent format that provides greater specificity for Lyme Disease. The prior assay utilized the C6 antigen, a portion of the VIsE antigen. In laboratory validation studies, manufacturer instruction for use and literature review, the Diasorin LIAISON® assay shows lower false positive rate and decrease in overall positivity rates relative to prior methods.

Background information: 

  • The LIAISON® assay provides presumptive qualitative detection of IgG and IgM antibodies to VlsE protein antigen of Borrelia burgdorferi in human serum.
  • This assay should be used only on samples from patients with signs and symptoms that are consistent with Lyme disease.
  • Positive or equivocal results should be supplemented by testing with Immunoblot confirmatory testing.
  • Positive Immunoblot confirmatory testing provides evidence of exposure to Borrelia burgdorferi and can be used to support a clinical diagnosis of Lyme disease.
  • Negative results by LIAISON® Borrelia burgdorferi assay do not completely exclude Lyme disease as early stages of infection or treatment for Lyme disease may be associated with low or undetectable antibody levels. If clinical suspicion remains high, repeat serologies or other testing should be considered.

Additional Test Information:

Specimen Requirements:0.5 mL serum from SST
Transport Temperature:Refrigerated
Stability (collection to initiation of testing):7 Days Refrigerated; 1 Month Frozen
Performed:Monday through Friday
Analytic Time:1 Day
Specimen Retention:1 Week
CPT Codes:86618

 

Please contact your Account Representative should you have any questions.

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Effective 3/02/2020, CPL will adopt the Martin-Hopkins method for calculated low-density lipoprotein cholesterol (calc. LDL-C). The method replaces the traditional Friedewald formula, which employed a ratio of 5 for triglyceride: very low-density lipoprotein (TRIG/VLDL) in order to compute LDL from total cholesterol, HDL cholesterol and triglycerides according to the following formula:

Calc. LDL-C = CHOL. – (HDL-C) – (TRIG/5)

While Friedewald has been the mainstay in LDL-C estimation for more than 40 years, it has been recognized that the equation tends to underestimate directly measured LDL-C when TRIG is significantly elevated. In an evaluation of more than 1 million patients from the Very Large Database of Lipids (VLDL dataset), Martin and colleagues validated a novel equation which replaced the fixed ratio of 5 for VLDL-C with a factor that varied from approximately 3 to 12 based on a patient's individual non-HDL-C and TRIG values.

Calc. LDL-C = CHOL. – (HDL-C) – (TRIG/NOVEL FACTOR)

With implementation of the novel factor, Martin-Hopkins shows higher accuracy as triglycerides trend higher and non-HDL cholesterol and LDL-C trend lower. Improved accuracy for lower values of estimated LDL is increasingly important in the 2018 American Heart Association/American College of Cardiology (AHA/ACC) guidance which recommends that many patients be managed at an LDL threshold of 70 mg/dL. The net effect of the transition to Martin-Hopkins will be overall increased calculated LDL-C for patients who have elevated Triglycerides (150-400 mg/dL) and low non-HDL cholesterol. Of note, the reference intervals and guidance from expert groups are not changed. See image below.

Martin Hopkins vs. Conventional Method for Elevated Triglycerides (150-400 mg/dL) and Normal Triglycerides (<150 mg/dL)

As previously noted, the new estimate will not be performed for elevated triglycerides that exceed 400 mg/dL. In this case, directly measured LDL (test code 4228) is recommended. Please contact your CPL Account Representative for more details. 


REFERENCES:
Martin SS, Blaha MJ, Elshazly MB, et al. Comparison of a Novel Method vs the Friedewald Equation for Estimating Low-Density Lipoprotein Cholesterol Levels From the Standard Lipid Profile. Jama. 2013;310(19):2061. doi:10.1001/jama.2013.280532.

Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA / ACC / AACVPR / AAPA / ABC / ACPM / ADA / AGS / APhA / ASPC / NLA / PCNA Guideline on the Management of Blood Cholesterol A Report of the American College of Cardiology / American Heart Association Task Force on Clinical Practice Guidelines WRIT.; 2018. doi:10.1161/CIR.0000000000000625.

 

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The information provided below is current as of February 27, 2020.

 

Under the guidance of the US Centers for Disease Control and Prevention (CDC), Sonic Healthcare USA (SHUSA) laboratories are closely monitoring the Coronavirus 2019 (COVID-19) outbreak caused by SARS-CoV-2 (previously known as 2019-nCoV). To date, over 80,000 human infections have been confirmed.  More than 2500 patients have died.

 

Affected Geographic Areas with Widespread or Sustained Community Transmission:

  • China
  • Iran
  • Italy
  • Japan
  • South Korea
     

Imported cases have been identified in seven states in the US: Washington, California, Arizona Texas, Wisconsin, Massachusetts, and Illinois.
 

According to the CDC:

  • At least one person-to-person transmission in the U.S. has been reported.
  • No vaccine or specific treatment for COVID-19 is currently available.
  • Care is supportive.
     

Interim Guidance from the CDC for Healthcare Providers:

  • Infection control procedures are necessary to prevent infections from spreading during healthcare delivery. COVID-19 Infection Control recommendations provided by the CDC may be accessed at: https://www.cdc.gov/coronavirus/2019-nCoV/hcp/infection-control.html
  • For patients being evaluated with fever and acute respiratory illness, a detailed travel history is essential. The Criteria to Guide Evaluation of Patients Under Investigation (PUI) for COVID-19 are provided in the chart below. This information may also be accessed at: https://www.cdc.gov/coronavirus/2019-nCoV/hcp/clinical-criteria.html
  • In the event of a PUI for COVID-19, healthcare providers should immediately notify both infection control personnel at their healthcare facility and their local or state health department.
  • In coordination with local or state health departments, the CDC’s Emergency Operations Center (770-488-7100) will assist local/state health departments to collect, store, and ship specimens appropriately to CDC, including during after hours or on weekends/holidays.
  • While COVID-19 testing can currently only be conducted at the CDC, laboratory testing for other pathogens from PUIs (including testing for influenza, RSV, etc.) should not be delayed. In order to provide adequate infection control, please notify Clinical Pathology Laboratories in advance of sending specimens from patients under investigation for COVID-19.
     

Criteria to Guide Evaluation of Patients Under Investigation (PUI) for COVID-19

Clinical FeaturesEpidemiological Risk
Fever or signs/symptoms of lower respiratory illness (e.g. cough or shortness of breath)Any person, including health care workers, who has had close contact with a laboratory-confirmed COVID-19 patient within 14 days of symptom onset
Fever and signs/symptoms of a lower respiratory illness (e.g., cough or shortness of breath)A history of travel from Hubei Province, China within 14 days of symptom onset
Fever and signs/symptoms of a lower respiratory illness (e.g., cough or shortness of breath) requiring hospitalization

A history of travel from mainland China 

within 14 days of symptom onset

 

For additional information, please visit https://www.cdc.gov/coronavirus/2019-nCoV/clinical-criteria.html

 

The outbreak caused by COVID-19 is rapidly evolving, and we will continue to monitor the situation and update you as new information becomes available.

Effective February 10, 2020, Clinical Pathology Laboratories will implement the Roche COBAS c502 immunoturbidometric assay for Beta-2-Microglobulin (B2M) to replace the Siemens Immulite 2000 method. In validation studies and literature review, the new assay demonstrates up to a 20% positive bias relative to the prior assay. As a result and in accordance with the package insert, CPL will:

  • Adjust reference intervals to those given in the chart below:
Testing PlatformAgeReference Range
Siemens ImmuliteAll< 2.6 mg/L

 

Roche c502

< 60 Years0.8 - 2.4 mg/L
≥ 60 Years≤ 3.0 mg/L
  • We will retain B2M specimens for 30 days from implementation until March 10th and offer to reestablish baselines until April 10th 2020 at clinician request. Tested specimens will be archived frozen, and will be available to compare Roche Cobas results to the prior method (Siemens Immulite) at no additional charge. After March 10th 2020, specimens will be retained refrigerated for 7 days.

Additional Test Information:

Specimen Requirements:0.5 mL serum from SST
Transport Temperature:Refrigerated
Stability (collection to initiation of testing):3 days Room Temperature; 7 days Refrigerated; 6 months Frozen
Performed:Monday through Friday
Analytic Time:1 day
Specimen Retention:30 days through 3/10/2020, then 7 days
CPT Codes:82232

Please contact your Account Representative should you have any questions regarding re-baselining and testing details.

 

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2019

Effective November 11, 2019, Clinical Pathology Laboratories (CPL) will convert the current test system for Hepatitis, HIV, and Tacrolimus from the Abbott Architect to the Roche Cobas e801 and e602 platforms utilizing an electrochemiluminescent immunoassay (ECLIA) methodology. The assays and unit codes listed below will be moving. There will be no changes to unit codes associated with this conversion.

AssayUnit Code(s)
Hepatitis A IgM2727, 272501
Hepatitis B core IgM4644
Hepatitis B core Total4655, 2729, 2730
Hepatitis B surface Antibody2737, 2738
Hepatitis B surface Antigen2736, 2739
Hepatitis C 4557, 4651, 4675, 4677
HIV 1/23540
Tacrolimus4272

As a result of this conversion, the following changes to reporting will be occurring:

  • Clinical Pathology Laboratories will no longer be reporting Hepatitis C Index Values, as index values are no longer recommended by the CDC in the determination of follow-up testing. Per the updated CDC guidelines, HCV RNA is the recommended confirmatory test for HCV. For more information visit the CDC website at http://www.cdc.gov/hepatitis/hcv/guidelinesc.htm
  • Clients may see a fewer “Equivocal” results due to increased specificity on the Roche Cobas e801/e602 platform and the absence of “Equivocal” as a reportable result for some analytes.
    • The following analytes will see fewer Equivocals due to increased sensitivity of the Roche Cobas:
      • Hepatitis A IgM
      • Hepatitis B surface Antibody
      • Hepatitis B surface Antigen
    • The following analytes will no longer report any results as “Equivocal”:
      • Hepatitis B core IgM
      • Hepatitis B core Total
      • Hepatitis C

Please contact your CPL Account Representative should you have any questions regarding this change.

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Effective 10/14/2019, a new formulation of Sex Hormone Binding Globulin (SHBG) reagent is implemented by the test manufacturer to correct long-term drift in assay recovery. Validation studies of the new SHBG formulation shows recovery 18% lower than the prior assay. The shift tends to increase the calculated free and bioavailable testosterone an average of 12% for adult males and 16% for adult females. The manufacturer does not provide guidance to adjust reference intervals for SHBG. Additionally, there is no specific recommendation to alter the calculated free or bioavailable testosterone reference ranges. The free and bioavailable testosterone are calculated from total testosterone and adjusted for SHBG and albumin binding according to Vermeulen1, and the reference ranges represent a collaboration with Sonic Reference Laboratory (SRL) who offer LC-MS based measurement of total testosterone, suitable for women and children. The following graph shows the shift in free testosterone as a function of SHBG (prior assay) and total testosterone when calculated using the method of Vermeulen:

SHBG Image

CPL is assessing free and bioavailable testosterone in the patient population to determine suitability of established reference ranges.

 

Order Codes:4933 (SHBG), 4937 (Testosterone, free/total), 4143 (Testosterone, Bioavailable, free and total), 2991 (Transgender hormone profile)
Test Method:Roche COBAS electrochemiluminescent immnoassay
Specimen Requirements:2 mL serum
Transport Temperature/StabilityRefrigerated, 5 days
Performed:Monday through Friday
Analytic Time:1 Day
Reference Ranges:

Various

CPT Codes:84270, 84403


1: “A Critical Evaluation of Simple Methods for the Estimation of Free Testosterone in Serum”, Vermeulen, A, Verdonck, L., Kaufman, J.M., Journal of Clinical Endocrinology & Metabolism, 84:10, October 1999, 3666-3672.  

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Effective 10/28/2019, Clinical Pathology Laboratories (CPL) will no longer accept the blue Hologic Unisex Swab Collection Kit for rectal or pharyngeal samples. From this date forward, the orange Hologic Multitest Swab Collection Kit (also known as “SimpleSwab”) will be the only acceptable collection device for the following C. trachomatis (CT) and/or N. gonorrhoeae (NG) tests:

Unit CodeTest Name
3755CT/NG, Rectal and Pharyngeal (submit two swabs, sources marked)
3770

CT/NG, Rectal or Pharyngeal (submit one swab, source marked)

 

DISCONTINUED:RECOMMENDED:
Hologic Unisex Swab Collection Kit

Hologic Multitest Swab Collection Kit (also known as “SimpleSwab”)

Between now and 10/28/2019, submission of specimens using either of these collection kits will be accepted, but please be aware that specimens collected after 10/28/2019 should only be submitted using the orange Multitest Collection Kit Swabs. The blue Unisex Swabs are still required for endocervical and male urethral samples, particularly as the device includes a female cleaning swab.

Please contact your Account Representative or your local CPL supply department to to obtain the orange Multitest swabs as needed for the changes described above. 

NOTE: This change is being made as a result of recent FDA clearance of the Multitest Swab Collection Kit for this testing which was formerly performed on the Unisex Swab based on validations conducted by CPL.

Order Codes:3755, 3770, 3771, 3772
Test Method:Transcription-mediated amplification (TMA)
Specimen Requirements:Rectal / Pharyngeal specimen obtained with Hologic Multitest Swab
Specimen Rejection Criteria:Hologic Unisex Swab
Transport Temperature/StabilityRefrigerated or room temperature, 2 months
Performed:Monday through Friday
Analytic Time:1 - 2 Days
Reference Range:

Negative

CPT Codes:87491, 87591

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CPL requests that all cytology and histology specimen containers be labeled with two patient identifiers at the time of collection. In clinical practice, patient safety protocols require a minimum of 2 patient identifiers to be used to definitively identify and match patient information. This practice is required for all primary specimen containers and submitted slides.

Specimen containers should be labeled with:

  • Full patient name (both first and last name)
  • A second identifier such as Date of Birth (DOB), hospital or clinic number, patient ID number, accession number, requisition number, or any other unique number for the patient
  • Source of specimen must be noted on the specimen container and/or submitted slides

Slides and/or smears submitted with patient material affixed should be labeled in pencil with:

  • Patient full name
  • Specimen source or site
  • If preparing both fixed and unfixed (air-dried) slides, mark the slides accordingly with clear indication of the air-dried (unfixed) slides

The primary specimen container is the innermost container received by the laboratory that actually holds the specimen, such as a tissue vial or slide.

  • Patient’s correctly spelled first and last name
  • Patient’s date of birth
  • Patient ID number, if applicable
  • Hospital, clinic or accession number, if applicable
  • Account name, address, phone, and account number
  • Requesting physician’s name
  • Source of specimen corresponding to specimen container
  • Note: If multiple tissue specimens are collected on the on same patient – ensure the specimens are listed on the requisition in order and the containers correlate with the requisition (A, B, C). A source should be listed for each specimen.
  • Patient clinical history 

Proper sample identification is critical to specimen integrity from the time of collection, to laboratory processing, testing and result reporting. 

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Opiate and prescription medication abuse constitutes a continuing public health crisis in the United States. According to recent estimates by the CDC, more than 90 Americans die each day from opiate overdose,and current estimates place the total economic burden of prescription opiate medication misuse alone at $78.5 billion a year.To monitor patient compliance with prescribed medications and to identify recent use of non-prescribed medications or illicit substances, Clinical Pathology Laboratories (CPL) in partnership with Sonic Reference Laboratory (SRL), A Sonic Healthcare Company, will begin to offer in-house Drug Monitoring Profiles designed for patients who have been prescribed pain management or other controlled substance prescription medications starting on July, 15 2019. 

CPL and SRL’s Drug Monitoring program includes testing for 30 different classes of drugs with screening performed by liquid chromatography-tandem mass spectrometry (LC-MS/MS) or immunometric techniques and with reflex or directly ordered confirmation performed by high-resolution LC-MS/MS. Individual classes range from one to many individual tests (see attached Drug Monitoring Attachment). In addition to individual classes, providers may choose profiles as appropriate to meet the needs of their patient compliance monitoring: 

Profile NameScreen CodeScreen/Reflex CodeClassesComponents
Drug Monitoring Profile 1246524669Classic opiates, oxycodone, fentanyl, benzodiazepines, amphetamines, designer amphetamines, gabapentin/pregabalin, ethanol and typical illicits
Drug Monitoring Profile 22467246815Profile 1 + meperidine, methadone, tapentadol, tramadol, naloxone/naltrexone/butorphanol, buprenorphine.
Drug Monitoring Profile 32469247116Profile 2 + skeletal muscle relaxants.
Drug Monitoring Profile 42472247323Profile 3 + barbiturates, cathinones (bath salts), dextromethorphan, D-type illicits (DMT, MEO- DMT), K-type illicits (Kava, Kratom), ketamine and synthetic cannabinoids.
Comprehensive Drug Monitoring Profile2451245226Profile 4 + anticonvulsants, antidepressants, antipsychotics.

Further notes about this service:

  1. Natural cannabinoids, nicotine, and non-opioid analgesics (e.g. acetaminophen) can be ordered separately with any one of the panels above. These medications may be outside of the specifications of many monitoring programs. 

  2. Short acting sedatives (Zolpidem, Zaleplon, Zopiclone) can be ordered separately with any one of the panels above. These are best assessed with use of a frozen specimen as they have decreased refrigerated stability. 

  3. For medication review in context of test results, please submit a list of prescribed medications. The Drug Monitoring Attachment can be used to document medications in addition to requesting specific Drug Monitoring Profiles or classes to be tested. 

  4. All specimens are also subjected to validity testing to assess for adulteration. Please review report notes carefully. 

  5. An enhanced report is available summarizing the medication list, all positive results and salient negative results (inconsistent negative – if a medication list is provided) at the top of the report with the results a complete analysis in the body of the report. Where possible, the enhanced report will include historical results. This report can be provided under separate cover. Please review this with your CPL Account Representative. 

 REFERENCES 

  1. Rudd RA, Seth P, David F, Scholl L. Increases in Drug and Opioid-Involved Overdose Deaths — United States, 2010–2015. MMWR Morb Mortal WklyRep. 2016;65. doi:10.15585/mmwr.mm655051e1. 
  2. Florence CS, Zhou C, Luo F, Xu L. The Economic Burden of Prescription Opioid Overdose, Abuse, and Dependence in the United States, 2013. MedCare. 2016;54(10):901-906. doi:10.1097/MLR.0000000000000625. 

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Printable Drug Monitoring Attachement

Effective July 1, 2019, Clinical Pathology Laboratories will change the current reagents and instrumentation for lymphocyte subset analysis and enumeration to the Beckman Coulter AQUIOS CL Flow Cytometry System using AQUIOS Tetra-1 and Tetra-2+ Panels.
NOTE: Adult reference ranges and specimen stability will be updated concurrent with this change.

Fluorochrome

 FITCRD1ECDPC5
AQUIOS Tetra-1CD45CD4CD8CD3
AQUIOS Tetra-2+CD45CD16+56CD19CD3

 

The AQUIOS CL is a fully automated flow cytometry system based on precise volumetric sampling to produce efficient, high-throughput lymphocyte subset analysis. In the clinical diagnosis and management of immune deficiency diseases, accuracy and precision in the enumeration of relative (percent) and absolute lymphocyte subsets is critical. The volumetric AQUIOS CL method eliminates the need for and variability produced by the introduction of fluorescent beads to the specimen. The platform is validated for identification and enumeration of T, B, and NK lymphocytes in whole blood.

Order Codes:4870, 5664, 4875, 4873, 4865, 4813, 4594, 3735*
Test Method:AQUIOS Tetra-1 and Tetra-2+ Lymphocyte Subset Analysis
Specimen Requirements:4 mL EDTA Whole Blood*
Specimen Rejection Criteria:Hemolysis, Refrigerated Samples, Frozen Samples, and Heparin Samples*
Transport Temperature/StabilityCritical Room Temperature* up to 2 days
Performed:Monday - Sunday*
Analytic Time:1 day*
Reference Ranges (18YRS):

CD3% 58.0-84.0%

CD3 ABS 850-2240 cells/μL

CD4% 34.0-65.0%

CD4 ABS 520-1470 cells/μL

CD8% 13.0-38.0%

CD8 ABS 205-920 cells/μL

CD19% 6.0-25.0%

CD19 ABS 87-507 cells/μL

CD16+56% 4.0-27.0%

CD16+56 ABS 74-562 cells/μL

CPT Codes:86360, 86359, 86357, 86355*

 

*Unchanged from previous version

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Effective March 4, 2019

Clinical Pathology Laboratories (CPL) will change current immunochemistry instrumentation and reagents to Roche COBAS® Electrochemiluminescent (eCLIA) methodology for the following assays:

  • Adrenocorticotropic hormone (ACTH)
  • C-peptide
  • Dehydroepiandrosterone sulfate (DHEA-S)
  • Human growth hormone (HGH)
  • Insulin-like growth factor 1 (IGF-1)
  • Insulin-like growth factor binding protein 3 (IGF-BP3)
  • Intact parathyroid hormone (iPTH)

The Roche assays provide improved precision and sensitivity, partially due to high-specificity biotin-streptavidin interactions in the immunoassay.1 As a result of this change all related reference ranges, specimen requirements, analytic measuring ranges and interferences were reviewed. The reference ranges for all analytes are modified in the validation process, with gender and age-stratification applied as appropriate. For certain assays, previously supplied Tanner charts are not currently available; instead, providers may reference granular gender- and age-stratified normal ranges. The Tanner charts may be reestablished for specific analytes with literature review and after accumulation of population data and analysis.

The reference interval changes have been distributed to the interfaced laboratory users group in a separate communication. If you or your practice requires a chart of the reference intervals across gender or age, please contact your CPL Account Representative.

Laboratory reports will be appended with a notice of the change in reference range and method as a part of this transition. As always, please review your laboratory results in the context of the provided reference interval and flagging.

Please contact your CPL Account Representative should you have any questions regarding this change.

Assays may be susceptible to interference by high doses (e.g. >5 mg/day) of biotin. Patients should avoid high dose biotin supplements for at least 8 hours prior to phlebotomy.

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Dear CPL Client,

We have just received a notice from Beckman-Coulter, the manufacturer of our Thyroglobulin Antibody assay reagent, that a possibility exists for decreased sensitivity for Thyroglobulin Antibody detection in a subset of patient samples tested with specific lot numbers of reagent. CPL was provided with the impacted lot numbers to test patients during the time period of 11/4/2018 to 2/19/2019. CPL immediately replaced this reagent lot with a new formulation not affected by this issue.

With potentially decreased sensitivity for TG Antibody, the impacted results may be inconsistent with clinical presentation, other laboratory tests, or imaging results. If you suspect that this issue impacted your patients’ results, please contact your CPL Account Representative to review and arrange for reassessment. For clinical questions regarding this testing, please contact customer service at 800.633.4757.

We regret the inconvenience that this may cause you and your patients.

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2018

Effective December 10, 2018,

Clinical Pathology Laboratories (CPL) will no longer offer Helicobacter pylori (H. pylori) serology testing in support of the current diagnostic guidelines for H. pylori. The Effective December 10, 2018, Clinical Pathology Laboratories (CPL) will no longer offer Helicobacter pylori (H. pylori) serology testing in support of the current diagnostic guidelines for H. pylori.

The discontinued tests are as follow:
Order CodeTest Name
4565H. pylori IgG, Qualitative 
4496H. pylori Antibody Reflex Quantitative
4611H. pylori IgA Antibody
4672H. pylori IgG Antibody
4607H. pylori IgM Antibody
4449H. pylori IgG/IgA Antibodies
4609H. pylori IgG, IgM, IgA Quantitative
CPL recommends the following alternative assays:
Order CodeTest Name
4499H. pylori Antigen, Stool
5591H. pylori (Breath)
5653H. pylori (Breath), Pediatric 

 

To better support high quality patient care, CPL will inactivate the serology test codes for H. pylori listed above and recommend active infection assays. These changes are consistent with the current diagnostic guidelines of the American College of Gastroenterology (ACG) and the American Gastroenterology Association (AGA) that recommend either the urea breath test or the stool antigen test as preferred testing modalities for active H. pylori infection. These alternative noninvasive testing methods demonstrate higher clinical utility, sensitivity and specificity.

Serologic evaluation of patients to determine the presence or absence of H. pylori infection is no longer considered clinically useful. As a result, many insurance providers are no longer providing coverage to patients for serologic testing. Antibody tests cannot distinguish between active and past infection with adequate sensitivity and specificity. Despite older literature suggesting that IgG serology can be used as a test of cure after 18 months, this has shown to be inaccurate. Both the urea breath test and stool antigen test are FDA cleared for use as a test of eradication.

Please contact your CPL Account Representative should you have any questions regarding this change.

Choosing Wisely: Fifteen Things Physicians and Patients Should Question, 2016; American Society for Clinical Pathology (ASCP)

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Effective September 10, 2018

Clinical Pathology Laboratories (CPL) will no longer offer BNP (order code 5585). Consider NT-proBNP (order code 5722) as replacement. NT-proBNP offers better stability and reduced interference to common Neprilysin inhibitors.

Atrial- and brain-type natriuretic peptides (ANPs and BNPs) are produced in cardiac tissues in response to ventricular dysfunction and atrial distension.

NT-proBNP aids in the:

  • Diagnosis and prognosis of individuals suspected of having congestive heart failure
  • Risk stratification of patients with acute coronary syndrome and congestive heart failure
  • Assessment of increased risk of cardiovascular events and mortality in patients at risk for heart failure who have stable coronary artery disease

NT-proBNP, in contrast to Brain Natriuretic Peptide (BNP), is:

  • Unaffected by the new class of Neprilysin Inhibitors (e.g. Entresto)
  • Suitable as a biomarker for congestive heart failure
  • Stable when collected, stored and transported at ambient, refrigerated and frozen temperatures

The table below demonstrates NT-proBNP performance characteristics by age range.

 MaleFemale
Age in Years45-5455-6465-74> 7545-5455-6465-74> 75
% Sensitivity88.269.691.786.590.589.394.381.8
% Specificity93.387.886.788.985.579.957.887.9
% Prevalence1.86.26.89.81.33.46.69.7
% NPV99.899.299.398.899.999.599.397.8
Order Code/ Test Name:5722  NT- proBNP
Test Method:Electrochemiluminesence Immunoassay (ECLIA)
Specimen Requirements:2 mL serum. Allow Serum Separator Tube (SST) to clot in an upright position for at least 30 minutes, then centrifuge sample within 2 hours of collection. Refrigerate (2-8 °C) Note: Samples should not be collected from patients receiving therapy with high Biotin doses (> 5 mg/day) until at least 8 hours following the last Biotin administration.
Specimen Rejection Criteria:Grossly hemolyzed specimens will be rejected
Transport Temperature:Refrigerated (2 - 8 °C)
Stability (collection to initiation of testing):

Ambient: (15 - 25 °C) 3 days

Refrigerated: (2 - 8 °C) 6 days

Frozen: (≤ -20 °C) 1 month

Performed:Monday through Friday
Analytic Time:1 day
Reference Range:

< 50 years: 450 pg/mL or less

50-75 years: 900 pg/mL or less

> 75 years: 1800 pg/mL or less

CPT Code:83880

 

If you have concerns about patients with known BNP baselining, please contact your CPL Account Representative.

Printable Version

Date: June 4, 2018

To: CPL Client

From: Compliance Department

Re: Annual Notice to Physicians

Clinical Pathology Laboratories (CPL) is providing annual notification to our clients of the Medicare policies governing the ordering and reimbursement of laboratory tests. CPL is committed to promoting awareness of and adherence to these policies. In accordance with the Office of the Inspector General’s (OIG) Compliance Program Guide for Clinical Laboratories, we are providing the following information about Medicare requirements.

Medicare Medical Necessity Policy

Medicare will only pay for the tests that meet the Medicare definition of “medical necessity”. Medicare may deny payment for a test that the physician believes is appropriate, such as a screening test, but which does not meet the Medicare definition of medical necessity. 

Medicare Laboratory National Coverage Determinations (NCDs) and Local Coverage Determinations (NCDs)

Coverage determination policies define the medical conditions through the inclusion of a list of ICD (diagnosis) codes for which these tests are covered or reimbursed by Medicare. HIPAA regulations require ICD code(s) to be present on each claim filed. These codes must also be documented in the patient’s medical records.

NCDs: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/LabNCDsICD10.html

LCDs: https://www.novitas-solutions.com Novitas Solutions Jurisdiction H

Frequency Limitations for Laboratory Tests

Certain laboratory tests have specific frequency limitation requirements. The limitations may apply to tests from the laboratory NCDs and LCDs.

Medicare Preventive Screening Laboratory Tests

Certain preventive screening laboratory tests are covered services for Medicare beneficiaries. Benefit coverage is specific for each service, covered diagnosis codes(s), coverage requirements, and frequency limitations.

https://www.cms.gov/Medicare/Prevention/PrevntionGenInfo/medicare-preventive-services/MPSQuickReferenceChart-1.html

American Medical Association (AMA) Organ or Disease-Oriented Panels The (AMA) panels were developed for coding purposes only and should not be interpreted as clinical parameters. Organ and disease-oriented panels will only be paid by Medicare when all tests within the panel are deemed medically necessary by Medicare. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c16.pdf

Section 90.2 – Organ or Disease Oriented Panels

Reflex Testing

Reflex testing occurs when initial test results are positive or outside normal parameters and indicate that a second related test is medically appropriate or required by state, regulatory or accreditation standards. 
Advance Beneficiary Notice of Non-Coverage (ABN)

  • Limited Coverage – An ABN is required if the diagnosis is not covered
  • Frequency Limit - An ABN is required at each encounter for frequency limited tests
  • Non-Coverage – An ABN is required for experimental or research use tests or tests designated by Medicare an non-covered

https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs.html Manual 100-04 Medicare Claims Processing Manual

Chapter 30 Financial Liability Protections Section 50 Form CMS-R-131 Advance Beneficiary Notice of Non-Coverage (ABN) 2018 Medicare Clinical Laboratory Fee Schedule Effective January 1, 2018, CLFS rates are based on weighted median private payor rates as required by the Protecting Access to Medicare Act (PAMA) of 2014 https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Clinical-LaboratoryFee-Schedule-Files.html Additional details can be found at PAMA regulations. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/PAMARegulations.html Medicare Part B National Correct Coding Initiative (NCCI) Edits The Medicare NCCI was implemented to promote national correct coding methodologies and to control improper coding leading to inappropriate payment. https://www.cms.gov/Medicare/Coding/NationalCorrectCodInitEd/index.html
Contact Information The Medical Directors and other pathologists are available to discuss appropriate testing and test ordering. Please call 512.339.1275 or 800.595.1275 for assistance. You may also contact our Compliance Department at compliancedept@cpllabs.com. Please review this notice with all appropriate staff. 

Printable Version

Effective June 18, 2018, Clinical Pathology Laboratories (CPL) will no longer offer in-house testing for Cancer Antigen 27.29 (CA 27.29) due to manufacturer reagent unavailability. Cancer Antigen (CA 15-3), order code 4827, testing is routinely performed in-house and may be considered an appropriate alternative.

Both CA 27.29 and CA 15-3 are mucin antibodies which detect soluble forms of MUC-1, a transmembrane mucin which can become overexpressed in epithelial cancer cells. Analytic antibodies for CA 27.29 partially overlap the binding sites used for CA 15-3 testing, yielding clinically similar results. According to Centers for Medicare and Medicaid Services (CMS) policy, CA 27.29 is equivalent to CA 15-3 in its usage in management of patients with breast cancer. Serial tumor marker testing must be used in conjunction with other clinical methods for monitoring breast cancer. If medically necessary for monitoring, clinicians should consistently use either CA 15-3 or CA 27.29, not both. CPL will offer rebaselining for initial transition from CA 27.29 to CA 15-3 from June 18, 2018 to August 31, 2018.

Please contact your Account Executive should you have any questions regarding rebaselining and testing details.

Order Code/Test Name:4827 Cancer Antigen 15-3
Test Method:Electrochemiluminesence Immunoassay (ECLIA)
Specimen Requirements:2 mL serum. Allow SST to clot in an upright position for at least 30 minutes, then centrifuge sample within 2 hours of collection. Refrigerate. Note: Do not collect samples from patients receiving therapy with high biotin doses (>5 mg/day) until at least 8 hours following the last biotin administration.
Transport Temperature:Refrigerated
Stability (collection to initiation of testing):

Ambient: (15 - 25 °C) 2 days

Refrigerated: (2 - 8 °C) 5 days

Frozen: (≤ -20 °C) 3 months

Performed:Monday through Friday PM Shift
Analytic Time:1 day
Reference Range:≤25 U/mL
CPT Code:

86300  (LOINC code:  6875-9)

Limited Coverage Test for Medicare. Advance Beneficiary Notice of Non-Coverage (ABN) required if diagnosis not covered

Printable Version

Effective 06/18/2018, Clinical Pathology Laboratories (CPL) will replace current drug of abuse (DAU) screening and screening with reflex confirmation profiles.

The new profiles provide:

  • Reformulation and recombination of classes for profile testing, more relevant to current societal trends
  • Standardization of drug thresholds to high sensitivity cutoff values
  • Addition of the following analytes in specific profiles for testing:
    • Fentanyl  
    • Buprenorphine
    • 6-Acetylmorphine
    • MDMA (Ecstasy)
  • Expansion of testing for adulterants with disqualifying comments added to specimens determined to be altered
  • Expansion of interpretive notes on reports regarding the method, cutoff values, and specific drugs that may or may not be detected by the screening method
Test NameOrder CodeTests Detected
Drug of Abuse, 8 Analytes No Confirmation3305Amphetamines, Barbituates, Benzodiazepines, Cannabionoids, Cocaine, Opiates, Phenyclidine
Drug of Abuse, 8 Analytes w/ Confirmation3306Amphetamines, Barbituates, Benzodiazepines, Cannabionoids, Cocaine, Opiates, Phenyclidine
Drug of Abuse, 9 Analytes No Confirmation3316Amphetamines, Barbituates, Benzodiazepines, Cannabionoids, Cocaine, Opiates, Phenyclidine, EtOH
Drug of Abuse, 9 Analytes w/ Confirmation3315Amphetamines, Barbituates, Benzodiazepines, Cannabionoids, Cocaine, Opiates, Phenyclidine, EtOH
Drug of Abuse, 10 Analytes No Confirmation3307Amphetamines, Barbituates, Benzodiazepines, Cocaine, Opiates, Phenyclidine, Methadone, Buprenorphine
Drug of Abuse, 10 Analytes w/ Confirmation3308Amphetamines, Barbituates, Benzodiazepines, Cocaine, Opiates, Phenyclidine, Methadone, Buprenorphine
Drug of Abuse, 11 Analytes No Confirmation3317Amphetamines, Barbituates, Benzodiazepines, Cannabionoids, Cocaine, Opiates, Phenyclidine, Methadone, Buprenorphine
Drug of Abuse, 11 Analytes w/ Confirmation3254Amphetamines, Barbituates, Benzodiazepines, Cannabionoids, Cocaine, Opiates, Phenyclidine, Methadone, Buprenorphine
Drug of Abuse, 12 Analytes No Confirmation3310Amphetamines, Barbituates, Benzodiazepines, Cannabionoids, Cocaine, Opiates, Phenyclidine, Methadone, Buprenorphine, EtOH
Drug of Abuse, 12 Analytes w/ Confirmation3311Amphetamines, Barbituates, Benzodiazepines, Cannabionoids, Cocaine, Opiates, Phenyclidine, Methadone, Buprenorphine, EtOH
Drug of Abuse,  13Analytes No Confirmation3312Amphetamines, Barbituates, Benzodiazepines, Cannabionoids, Cocaine, Opiates, Phenyclidine, Methadone, Buprenorphine, Fentanyl, 6-Acetylmorphine, MDMA/Ecstasy
Drug of Abuse, 13 Analytes w/ Confirmation3309Amphetamines, Barbituates, Benzodiazepines, Cannabionoids, Cocaine, Opiates, Phenyclidine, Methadone, Buprenorphine, Fentanyl, 6-Acetylmorphine, MDMA/Ecstasy
Drug of Abuse, 14 Analytes No Confirmation3313Amphetamines, Barbituates, Benzodiazepines, Cannabionoids, Cocaine, Opiates, Phenyclidine, Methadone, Buprenorphine, Fentanyl, 6-Acetylmorphine, MDMA/Ecstasy. EtOH
Drug of Abuse, 14 Analytes w/ Confirmation3314Amphetamines, Barbituates, Benzodiazepines, Cannabionoids, Cocaine, Opiates, Phenyclidine, Methadone, Buprenorphine, Fentanyl, 6-Acetylmorphine, MDMA/Ecstasy. EtOH

 

Additional information for the newly added analytes:

  • Fentanyl: a potent synthetic opioid usually not detectable by standard opiate testing
  • Buprenorphine: a semisynthetic opioid receptor partial agonist, used in place of or with methadone for detoxification or opioid replacement therapy
  • 6-Acetylmorphine: a heroin metabolite, produced very quickly from the short-lived parent and detectable in the urine for approximately 8 hours after use
  • MDMA (Ecstasy): a sympathomimetic stimulant related to amphetamine with significantly fewer CNS stimulant properties than methamphetamine 

 Testing to be eliminated from the screening and screen/reflex profiles:

  • Methaqualone (Quaaludes): this drug was discontinued in the US in 1985; screening programs very rarely produce positive results, most of which are determined to be false positives
  • Propoxyphene (Darvon): this drug was discontinued in the US in 2010 due to cardiac arrhythmias

The following order codes will be discontinued:

3202, 3203, 3204, 3205, 3206, 3210, 3211, 3212, 3220, 3225, 3250, 3251, 3255, 3258, 3270, 3272, 3285, 3290, 3295, 3296, 5813, 5867, 5869, and 5910.

Order code 3254, formerly known as DRUG ABUSE PANEL 10 WITH OXYCODONE will be modified as represented in the chart on reverse side.

The testing represents conventional drug of abuse screening using immunoassay (IA) methods and, where requested, reflex confirmation by chromatography with mass spectrometry. This IA technology is designed to react at a certain threshold to particular members of a drug class. For some classes certain compounds will not measure above the screen threshold. Additionally, chemically related compounds may trigger a "false positive" screen.

Confirmatory testing is performed for positive screens at an additional charge for those profiles designated “W/CONFIRM” on reverse side. Positive screens are reflexed and performed by a different technology, either gas chromatography with mass spectrometry (GC-MS) or liquid chromatography-mass spectrometry (LC-MS or LC-MS/MS if tandem). The confirmatory testing provides higher sensitivity testing with lower thresholds, definitive analyte identification and quantitation without analytic false positives. 

Additional test information:

Order Unit Code/Test Name:See table 
Test Method:Immunoassay Screen 
Specimen Requirements:50 mL Random Urine. No Preservative. Refrigerate.
Transport Temperature:Refrigerated
Stability (collection to initiation of testing):

Ambient, 15-25°C: 1 week

Refrigerated, 2-8°C: 1 week

Performed:Monday through Friday / PM Shift
Analytic Time:1 day
Reference Range:Negative 
CPT Code:80307

 

Limited Coverage Test for Medicare. Advance Beneficiary Notice of Non-Coverage (ABN) required if diagnosis not covered. Frequency Limit Test for Medicare. Advance Beneficiary Notice of Non-Coverage (ABN) is always required. There must be documentation, by the clinician, in the patient’s medical record, to support the medical necessity and frequency of drug testing on an individual basis.

Please contact your CPL Account Representative should you have any questions regarding this change. 

Printable Version

Effective March 26, 2018, Clinical Pathology Laboratories will change the current instrumentation for Insulin testing from Siemens Immulite to Roche Cobas e602 using Electrochemiluminescence Immunoassay (ECLIA) technology. As a result of this change, all related reference ranges were reviewed and modified as listed below.

Order CodeInsulin ValueSiemens Reference Range µIU/mLRoche Reference Range µIU/mL
2760Random4-132-21
2749Fasting4-132-21
27561/2 hour12-5822-133
27571 hour17-4633-104
27641 1/2 hour15-4429-99
27582 hour13-4225-93
27593 hourNot establishedNot established
27614 hourNot establishedNot established
27625 hourNot establishedNot established
27636 hourNot establishedNot established

Note: Reference ranges for timed specimens are given presuming a 75 gm oral glucose. The Random reference range presumes standard overnight fast as well.

Additional Test Information:

Specimen Requirements:2 mL serum from SST
Specimen Rejection Criteria:Hemolysis, Allow only 1 Freeze/Thaw Cycle
Transport Temperature:Refrigerated
Stability (collection to initiation of testing):24 Hours Room Temperature; 4 Days Refrigerated; 1 Month Frozen
Performed:Monday through Friday
Analytic Time:1 Day
Specimen Retention:1 Week 
CPT Code:83525

Please contact your Account Executive should you have any questions regarding this change. 

Printable Version

Effective April 2, 2018, Clinical Pathology Laboratories is pleased to announce a change in methodology and reference range for Thyroxine Binding Capacity (TBC) and a change in reference range for total thyroxine (T4) with transition to the Roche Cobas electrochemiluminescence immunoassay (ECLIA) method. Traditionally, the excess TBC of serum was indirectly assayed with a T3-resin uptake (T3RU). The Roche ECLIA method is a direct measure of TBC which will also allow a calculated T-Uptake in percentage. Free thyroxine index (FTI), an estimate of the free fraction of T4, is calculated using the TBC and Total T4.

T-Uptake:

  • Increased in hyperthyroidism or with decreased unsaturated Thyroid Binding Globulin (TBG)
  • Decreased in hypothyroidism or with increased unsaturated TBG

TBC:

  • Decreased in hyperthyroidism or with decreased unsaturated TBG
  • Increased in hypothyroidism or with increased unsaturated TBG

FTI:

  • Historically, FTI was the product of total T4 and T3RU divided by 100
  • Using Roche, FTI is the ratio: T4/TBC

Changes in Reporting:

AssayTest CodePrior Reference RangeNew Reference RangeNotes
ThyroxineT428194.5-12.0 ug/dL4.5-10.5 ug/dL 
T-Uptake%281724.3-39.0 %24.3-39.0%Mathematically derived from TBC
Thyroxine Binding CapacityTBC28171New0.8-1.3 (no units)Directly proportional to unsaturated thyroxine binding capacity.
Corrected T4FTI28201.5-3.80 (no units)4.2-11.6 ug/dLRatio of T4/TBC. Thyroid I and II Profiles (profile codes 117 and 119) contain Thyroxine (T4), T-Uptake, Corrected T4 (FTI) 
Order Unit Codes and Test Names:2817 T-Uptake / 2819 Thyroxine (T4)
Specimen Requirements:2 mL serum. Allow SST to clot in an upright position for at least 30 minutes, then centrifuge sample within 2 hours of collection. Refrigerate. Note: Do not collect samples from patients receiving therapy with high biotin doses (>5 mg/day) until at least 8 hours following the last biotin administration. 
Transport Temperature:Refrigerated
Stability (collection to initiation of testing):

Ambient, 15-25°C: 1 day

Refrigerated, 2-8°C: 7 days

Frozen, (-15)- (-25)°C: 1 month

Performed:Monday through Friday / PM Shift
Analytic Time:1 day
CPT Code:T-Uptake: 84479 / Thyroxine (T4): 84436

 

Printable Version

Laboratory tests such as immunoassays use antibodies to detect and quantitate analytical compounds and often use a biotin linker to enhance sensitivity and accuracy. High dose biotin taken within 1 or 2 days or lower dose biotin taken within a few hours prior to sampling may affect the accuracy of laboratory testing for those assays that include a biotin component. 

As a consequence, the US Food and Drug Administration (FDA) has issued a Safety Communication: The FDA Warns that Biotin May Interfere with Lab Tests (https://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm586505.htm)

What does this mean for patients and providers?

  • Patients on high dose supplements of biotin, such as hair/nail/skin supplements, should refrain from taking them in the 24 hours prior to laboratory testing.
  • These supplements may or may not indicate they contain biotin prominently.
  • Patients taking prescribed megadose regiments (>150 mg biotin) should refrain from taking the supplement for 24-48 hours prior to laboratory testing, upon the advice of their physician.
  • Patients and physicians should review any lab test result that does not match the clinical presentation and consider if biotin interference is present. 

 Background information:

  • Biotin, or vitamin B7, is often found in multi-vitamins, prenatal vitamins, and dietary supplements, which may not be clear from the name of the supplement.
  • Patients and clinicians should be aware that a number of immunoassay lab tests, including but not limited to cardiovascular diagnostic tests, thyroid tests, and certain other hormone tests, may be affected by biotin interference.
  • The US recommended daily allowance (US RDA) for biotin is 0.03 mg.
  1. The amount of biotin often found in multivitamins does not typically cause significant interference.
  2. Supplements containing high biotin levels including those marketed for hair, skin, and nail benefits may contain 5-20 mg of biotin (200-600 times US RDA).
  3. Biotin levels higher than the recommended daily allowance may cause significant interference with affected lab tests. 

 References:

Printable Version