Parkview Labs News:

September 2020

Covid - 19 on the New Roche 6800  

Effective September 1, 2020, routine COVID-19, PCR testing (EPIC Test Code LAB14290) was moved from Quest Diagnostics to Parkview Regional Medical Center.  Testing is performed on the Roche Cobas 6800 using an assay that has received Emergency Use Authorization (EUA) from the FDA for the detection of the SARS CoV-2 virus.  Specimen requirements remain unchanged.  Please refer questions about this testing change to Dr. Xiaoying Wan, Molecular Technical Director, at 266-1639 or Ann Vick, Laboratory Chemistry Specialist, at 266-1587



Discontinuing Testing
 

Quantitative Biopsy Culture, LAB271, will no longer be available to order effective immediately. Replacement test recommendation is a standard semiquantitative bacterial culture. Please see Anaerobic Bacteria Culture, LAB233, for semi-quantitative bacterial culture. Specimens inappropriate for anaerobic culture or received in aerobic transport media will be cultured aerobically only. For any questions, please contact Landers Barber at 266-1593.


August 2020

SARS-CoV-2 (COVID-19)

 On August 20, the Respiratory Biofire Panel will include a target for SARS-CoV-2 (COVID-19). Testing will be performed at PRMC by the Microbiology lab, using the BioFire RP2.1 assay on the PCR FilmArray Torch. The test has been authorized by the FDA under an Emergency Use Authorization (EUA). A fact sheet will be available for distribution to healthcare providers and patients in the Parkview Health Laboratories Test Directory at http:\\lab.parkview.com.  The specimen type is nasopharyngeal swab placed in viral transport media (M4RT or red top Xpert Swab with pink fluid). Saline collections will not be accepted. Please consult Lab Test Directory for more details


Interleukin-6 (IL-6)


Effective August 11, 2020, Interleukin-6 (IL-6) (EPIC Test Code LAB3180) measurement will be performed by Parkview Health Laboratories at Parkview Regional Medical Center.  Testing will be performed using electrochemiluminesence (ECLIA) on Roche Cobas instrumentation using an assay that has received Emergency Use Authorization (EUA) clearance from the FDA to support care of patients with COVID-19 infection.  Please refer questions about this new test offering to Dr. Qi Wang, Chemistry Technical Director, at 266-1641 or Ann Vick, Laboratory Chemistry Specialist, at 266-1587

July 2020

Candia auris

Due to the emerging multi-drug resistant yeast, Candida auris, Infection Prevention/Control has requested a way to screen for C. auris. The new C. auris screen will include two new types of media: Salt Sabouraud Dex with Dulcitol broth and CHROMagar Candida agar. This new procedure will help eliminate most colonizing bacteria and other yeasts.  The new test will be available starting August 3, 2020. 

Epic code: LAB317                Soft Code: CXAUR

Clostridium difficile (C-diff)

Testing for GI pathogens will look differently starting August 4.  The GI Biofire Panel will no longer offer a C.diff result.  Testing specifically for Cdiff will go through the Cdiff Pathway.  See the Laboratory Test Directory on Team Parkview for more details. The new Cdiff testing protocol will be live August 4, 2020.

Test

Epic Code

Soft Code

Specimen Type

GI Biofire w/o C.diff

LAB2885

GIBIO

Loose, raw stool in a cup & a fecal eSwab

C.diff Pathway

LAB3080

CDGTO

Loose, raw stool in a cup

 
If you have any questions or concerns for either of the changes above please contact Landers Barber, Lab Microbiology Lead at 266-1593.


Respiratory Biofire Panel
Beginning Monday, July 27, the Respiratory Biofire Panel will include a target for
SARS-CoV-2 (COVID-19). Testing will be performed at PRMC by the Microbiology lab, using the BioFire RP2.1 assay on the PCR Film Array Torch. The test has been authorized by the FDA under an Emergency Use Authorization (EUA). A fact sheet will be available for distribution to healthcare providers and patients in the Parkview Health Laboratories Test Directory at http:\\lab.parkview.com.  The specimen type is nasopharyngeal swab placed in viral transport media (M4RT or red top Xpert Swab with pink fluid). Saline collections will not be accepted. Please consult Lab Test Directory for more details.If you have any questions or concerns please contact Landers Barber, Lab Microbiology Lead at 266-1593.FLOW 


Flow Cytometry Name Changes
 
With My Chart and the patients seeing their lab results, we are changing some of the names of the reports.  There was a concern about the patients reading Leukemia or Lymphoma.

Accession

Current Name:

Name Changed to:

FA

Flow Cytometry Acute Panel

    (no change)

Flow Cytometry Acute Panel

FB

Chronic Lymphocyte Leukemia (CLL) Panel

Flow Cytometry BM/Blood Lymphocyte Panel

FL

Lymphoma Evaluation Panel

Flow Cytometry Tissue/Fluid Lymphocyte Panel

If you have any questions or concerns please contact Lisa Derck, Lab Specialist at 266-6085.


 
June 2020

Covid Antibody Testing Update
Antibody testing for SARS-CoV-2 is now being offered by Parkview Health Laboratories at Parkview Regional Medical Center (PRMC) using the Roche anti-SARS-CoV-2, Total assay.  This FDA EUA cleared test offers a specificity of 99.8% and sensitivity near 100% when testing >14 days post-PCR confirmation. Testing requires serum and is orderable using EPIC test code IMO5257.
CDC interim guidelines for COVID-19 Antibody Testing state that, “currently, there is no identified advantage of assays whether they test for IgG, IgM and IgG, or total antibody.”  The full interim guidelines may be viewed at https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antibody-tests-guidelines.html. Based on the CDC interim guidelines, all requests for COVID-19 Antibody Testing, including IgG and/or IgM specific requests, will be reported using the Roche anti-SARS-CoV-2 assay. 
The current version of the Parkview Health COVID-19 Antibody Testing Guideline Statement may be viewed at https://parkviewhealth.sharepoint.com/sites/IP/COVID19/Forms/Clinical.aspx?id=%2Fsites%2FIP%2FCOVID19%2FOPG%2006-03-2020-1%20Updated%20COVID-19%20Antibody%20Testing%20Guideline%20Statement%2Epdf&parent=%2Fsites%2FIP%2FCOVID19.
Please refer questions about this new testing to Dr. Qi Wang, Chemistry Technical Director, at 266-1641 or Ann Vick, Laboratory Chemistry Specialist, at 266-1587.
 
Reporting Error for Tissue Transglutaminase
Parkview Health Laboratories recently identified an error in the cut-off value utilized for interpretation of Tissue Transglutaminase (tTG) IgG results.  This error resulted in the reporting of results that were incorrectly flagged as abnormally high (positive).  If you have received an abnormal (positive) result that you believe to be inconsistent with the patient’s history and find that retesting is indicated, tTG IgG repeat testing is available at no charge by contacting the laboratory Client Response Center at 266-1500.  Results reported after June 1, 2020 are unaffected by the error.  Questions about this issue may be referred to Dr. Qi Wang, Chemistry Technical Director, at 266-1641 or Ann Vick, Laboratory Chemistry Specialist, at 266-1587.

May 2020


Discontinue QGold Testing

The Parkview Test Utilization Committee reviewed issues found in the results for M. tuberculosis by means of Quantiferon Gold testing.  It was decided to discontinue this testing due to a large volume of indeterminate findings.
PHL Code:  QGOLD
On May 26, 2020, Parkview Health Laboratories will change the lower glucose critical flag from <40 mg/dl to <54 mg/dl for inpatients greater than 1 day of age.  The upper critical flag for inpatients and all critical flags for outpatients remain unchanged.  The glucose reference range remains unchanged.  This change is being made to align critical value notifications with the American Diabetes Association (ADA) definition of Level 2 hypoglycemia.  Please refer questions about this change to Dr. Qi Wang, Chemistry Technical Director, at 266-1641 or Ann Vick, Lab Chemistry Specialist, at 266-1587.

April 2020

Coagulation Reference Range Changes 5/6, 2020.

March 2020

This change is coordinated with the removal of amylase from many EPIC order sets.  Please refer questions about these panel changes to Dr. Qi Wang, Chemistry Technical Director, at 266-1641 or Ann Vick, Lab Chemistry Specialist, at 266-1587.
Additional information regarding Choosing Wisely Recommendations may be found at https://www.ascp.org/content/get-involved/choosing-wisely.  
February 2020
Beginning on February 19th, Pathology Reports will be named intuitively & can be viewed in the Path/Cyto Filter.  
 
The Lab Results Tree will also be updated to allow Pathology Reports to be located more easily & intuitively. 
 


Beginning February 12, 2020, the test set DAT with Reflex Elution (EPIC Test Code: LAB3172) will be performed by Parkview Health Laboratories at Parkview Regional Medical Center. This cascade of testing will aid in the diagnosis of autoimmune hemolytic anemia.  The specimen requirement for this test set is one pink tube. Please refer questions about this test set to Blood Bank Medical Director Dr. Craig McBride at 266-1637 or Blood Bank Specialist Annie Ilnicki at 266-6085. 
 
Methodology Changes for the Strep A
Strep A by isothermal nucleic acid amplification (NAA) will be replacing the Rapid Strep A test on February 19, 2020.  The new Strep A by NAA is a rapid, instrument-based, molecular diagnostic test utilizing isothermal DNA amplification technology for the qualitative detection of Streptococcus pyogenes, collected from throat swab specimens. 
 
It is intended to aid in the rapid diagnosis of Group A Streptococcus bacterial infections.  This assay meets the FDA requirements for no culture confirmation for negative results. There is no need to perform a culture on negative results for patients <18 years old, as the result is a true negative.  This new test will be performed at all the hospital labs, as well as the Ohio draw sites.
 
Please review included documentation*, and contact Dr. Craig McBride at 266-1637 or Landers Barber at 266-1593 with any further questions.

January 2020
The Myelin Basic Proteins, from the MS Panel are being delayed due to reagent issues. The specimens sent will be held to be ran after reagent issue resolved. All other tests in the MS Panel are being resulted.  Please contact the Carey Jacquay for any further questions at 266-1505.  
 
October 9, 2019
H-Pylori Stool
Effective November 4, 2019, Helicobacter pylori Stool Antigen (EPIC Test Code LAB2596) will be performed by Parkview Health Laboratories at Parkview Regional Medical Center Helicobacter pylori IgG (EPIC Test Code IMO28) testing will be discontinued.  These changes are being made to better comply with current testing guidelines from the American College of Gastroenterology for the diagnosis and monitoring of Helicobacter pylori infection.  Please refer questions about these test changes to Dr. Qi Wang, Chemistry Technical Director, at 266-1641 or Ann Vick, Laboratory Chemistry Specialist, at 266-1587.
Kappa/Lambda
Effective October 30, 2019, serum free kappa and lambda light chain with ratio (EPIC Test Code LAB2545) testing will be performed by Parkview Health Laboratories at Parkview Regional Medical Center.  Specimen requirements and reference ranges remain the same as those for the testing currently sent to Quest Diagnostics.  Testing will be performed using the Freelite assay on the Roche Cobas c502.  Please refer any questions about this test change to Dr. Qi Wang, Chemistry Technical Director, at 266-1641 or Ann Vick, Laboratory Chemistry Specialist, at 266-1587.
 
August 22, 2019
Beginning September 18, 2019, PSA, Free and Total (EPIC Test Code: LAB171) testing will be performed by Parkview Health Laboratories at PRMC.  Specimen requirements remain the same as those for the testing currently sent to Quest Diagnostics.  Testing will be performed using electrochemiluminesence immunoassay (ECLIA) technology on the Roche Cobas e801.  The following result interpretation is provided.   The diagnostic usefulness of % Free PSA has not been established in patients with total PSA below 2.6 ng/mL.  In men with total PSA values above 10.0 ng/mL, prostate cancer risk is determined by total PSA alone.  In patients with total PSA concentrations of 4-10 ng/ml the probability of finding prostate cancer on needle biopsy by age in years is:
      
%FREE PSA    PROBABILITY IN CANCER BY AGE IN YRS
   50-59 YRS      60-69 YRS   >=70 YRS
 
<=10            49%            58%              65%
11-18           27%            34%              41%
19-25           18%            24%              30%
>25              9%           12%              16%
August 13, 2019
June 12, 2019
Beginning June 19, 2019, monoclonal (M-spike) proteins identified on serum protein electrophoresis (EPIC Test Code LAB119) and serum immunofixation electrophoresis (EPIC Test Code LAB174) will be reported on their own result line instead of within an interpretive comment.  This change is being made to allow for easier viewing and trending within EPIC.  Please refer questions about this reporting change to Dr. Qi Wang, Chemistry Technical Director, at 266-1641 or Ann Vick, Laboratory Chemistry Specialist, at 266-1587.
May 30, 2019
Troponin T, 5th Generation
 
Effective Tuesday, June 11, 2019, Parkview Health Laboratories will transition from the current Troponin T assay to a high-sensitive, Troponin T, Generation 5 assay (EPIC Test Code: LAB3111).  Reporting will be in whole numbers utilizing units of ng/L.  Gender specific reference ranges of (Female) 0-10 ng/L and (Male) 0-15 ng/L will be utilized.  Values above 100 ng/L are considered to be critical and will be called.  PST (light green) plasma specimen requirements remain the same.  Please refer questions to Dr. Qi Wang, Chemistry Technical Director, at 266-1641 or Ann Vick, Laboratory Chemistry Specialist, at 266-1587.
 
Algorithm for use with Troponin T, Generation 5
To determine if a patient may have had a myocardial infarction, Troponin T, Generation 5 will be performed at zero and 2 hours.
 
If both the zero hour and 2-hour result is < 10 ng/L for women or < 15 ng/L for men and the 2-hour change is:
May 29, 2019
May 14, 2019
Coagulation Reference Range Changes
April 26, 2019
Ova and Parasite Evaluation, Test Code OVP, is no longer be available.
An MISC for each test will need to be ordered in EPIC for the following tests:
February 12, 2019
February 4, 2019
On Tuesday, February 12, 2019, the Parkview Health Laboratories will change the Calcium reference ranges.
The new ranges will be: <1 year of age:  8.7-10.5 mg/dL
                                                  1-4 years of age: 8.5-10.6 mg/dL
                                                  4-20 years of age 8.9-10.4 mg/dL
                                                  >20 years 8.5-10.3 mg/dL
Please contact Dr. Karen Wan, Pathologist, at 266-1639, or Richard Brown, Laboratory Chemistry Specialist, at 266-6083.
January 17, 2019
January 16, 2019
January 8, 2019
January 3, 2019
Changing Containers
From now thru February 1st Parkview Health Laboratory will be switching out the collection specimens for the Gastrointestinal Panel (Test Code: GIBIO).
November 30, 2018
Biotin and laboratory testing
June 1, 2018
April 30, 2018
March 26, 2018
The AABB consensus on CMV testing is that Leukocyte reduction by any method capable of achieving a residual leukocyte count < 5 x 106 allows for the reduction of transfusion-transmitted CMV to a level at least equivalent to the level occurring with the use of CMV-seronegative components transfused to CMV-seronegative recipients.
March 9, 2018
February 28, 2018
Parkview Health Laboratories will now include an Oxycodone screen in the Urine Drug Screen, Clinical. Laboratory code: UDS Epic Code/Test: LAB2673 – Drug Screen Urine
February 12, 2018
October 2017
June 2017
April 18, 2017
March 14, 2017
March 9, 2017
Click here for complete list of changes;
January 31, 2016
On February 28, 2017, Parkview Health Laboratories will begin converting Chemistry testing from the Siemens Dimension platform to the Roche Cobas platform. 
The rollout of the Roche instruments will occur in 4 phases:
                Feb 28, PRMC and PVH will go live on the Roche instruments.
                March 14, PHH and PWB will go live.
                May 2, PWH and PWR will go live.
                May 23, PNH and PLH will go live.
During this period of time, there will be limited standardization of reference ranges between the Laboratories.
The reference range changes are in the process of being evaluated and will be posted as soon as they are established.
The most significant change will be the use the current Troponin I to the Roche Troponin T assay.  The diagnostic criteria for Troponin T is:
 
Troponin T
   < 0.01 ng/ml - Does not indicate cardiac damage
   0.01 - 0.09 ng/ml - Abnormal, undetermined significance, repeat testing and     
                                   further testing  may be indicated according to clinical findings
 
  > 0.09 ng/mL - Consistent with myocardial infarction, if clinical characteristics 
                            correlate
 
Troponin I and Troponin T values are not interchangeable. It is recommended that if a patient is transported to a facility using the other Troponin, that the timing for serial determinations be reset.
Jennifer Marino, Roche Diagnostics Corporation Medical and Scientific Liaison, is available to answer questions concerning the conversion to Troponin T, Jennifer is working with nursing and physician groups to communicate the changes.   
 
For further information or questions, please contact Karen Wan, Laboratory Pathologist, 266-1639, or Richard Brown, Laboratory Chemistry Specialist, 266-6083.
 
New Testing
December 19, 2016
Teichoic Acid - Discontinued
MSH6 Mutation, One Exon, HNPCC - Discontinued (Now Order Quest 93945)
BRCAvantageTM, Single Site - Discontinued (Now Order Quest 93945)
Heavy Metal Screen, Whole Blood (Now Order Quest 7655)
November 11, 2016
October 10, 2016
June 30, 2016
June 20, 2016
Device Correction Notification:
June 1, 2016
May 31, 2016
New In-House Molecular Tests for GI Pathogens and Meningitis/Encephalitis
May 23, 2016
For those patients eighteen and older, a Group A Strep Culture (Soft Code: CXGRA) or Throat Culture (Soft Code: CXTHR) may be ordered separately if desired.
May 19, 2016
         PCT <=0.5 ng/ml = Low risk for progression to severe systemic infection(severe sepsis/septic shock.
CAUTION: PCT levels below 0.5 ng/ml do not exclude infection, because localized infections (without systemic signs) may be associated with such low levels. If PCT is measured very early after a bacterial challenge (usually <6 hours), these values may still be low. In this case, PCT should be re-assessed 6-24 hours later.
        
       PCT >0.5 to <=2 ng/ml= Moderate risk for progression to severe systemic infection (severe sepsis/septic shock).
The patient should be closely monitored both clinically and by re-assessing PCT within 6-24 hours.
       PCT >2 ng/ml = High risk for progression to severe systemic infection (severe sepsis/septic shock).
May 6, 2016
April 28, 2016
March 18, 2016
To be consistent with best practice, Parkview Laboratories are discontinuing the Thyroid Profile and Thyroid Profile with TSH tests on 4-5-16. All the tests included in these profiles are available individually. Orders previously placed for these profiles will be converted into the TSH with reflex Free T4. Questions can be directed to Dr. Steven Wang, Medical Director, at 266-1630.
    < 0.01 ng/mL Does not indicate cardiac damage
  
       0.01-0.09 ng/ml- Abnormal, undetermined significance, repeat testing and further 
                                   testing may  be indicated according to clinical findings                 
    > 0.09 ng/ml- Consistent with myocardial infarction, if clinical characteristics correlate
 
Vitamin B12
 
Scope of Biotin Interference on Roche System

 

 

EPIC Code:  IM0442
 
In the future the testing for M. tuberculosis will be:
 
The T-SPOT. TB test detects the immune response of T cells that have been stimulated by M tuberculosis antigens.  The test utilizes M tuberculosis-specific antigens that are absent from BCG strains and most non-tuberculosis mycobacteria.   The T-SPOT.TB test is an indirect test for M tuberculosis infection (including disease) and is intended for use in conjunction with risk assessment, radiography and other medical and diagnostic evaluations.
PHL Code:  SPOT
EPIC Code:  IM0178

 

Glucose Changes Critical Flag

 

 

Changes effective 5/6/2020 after 10am:
Prothrombin time reference range: 9.6 – 11.7 seconds (currently: 9.4-11.3).  
APTT reference range: 22.1 – 31.4 seconds (currently 22.7-31.7).
The unfractionated heparin therapeutic range remains unchanged.
Questions: contact Dr. Yi Zhuang at 266-1644
Effective March 24, 2020, serum amylase will be removed from the lab trauma (EPIC code LAB2650) and sepsis (EPIC code LAB2428) panels.  This is being done at the recommendation of the Parkview Health Test Utilization Committee in following the ASCP Choosing Wisely Recommendations.  
Intuitively Named Pathology Reports
DAT w/ Reflex Elution

 
Please refer any questions about this test change to Dr. Qi Wang, Chemistry Technical Director, at 266-1641 or Ann Vick, Laboratory Chemistry Specialist, at 266-1587.
Beginning September 3, 2019, Tacrolimus (Prograf) testing (EPIC Test Code IMO477) will be performed using an electrochemiluminescence immunoassay methodology on Roche Cobas instrumentation.  This is a change from the homogeneous particle-enhanced turbidimetric immunoassay method that is used currently.  Because of this, there may be some variation from prior evaluations.  Specimen requirements remain unchanged.  Please refer questions about this method change to Dr. Qi Wang, Chemistry Technical Director, at 266-1641 or Ann Vick, Laboratory Chemistry Specialist, at 266-1587.

<4 ng/L
Cardiac injury is not indicated
> 4 ng/L and <10 ng/L
The result is abnormal.  Cannot rule out myocardial injury.  Repeat test in 2 hours.
> 10 ng/L
Suspicious for myocardial infarction (MI).  Recommend clinical correlation.
 
If either the zero hour or the 2-hour result is >10 ng/L for women or >15 ng/L in men and the 2-hour change is:
<4 ng/L
The result is abnormal.  Mostly suggestive of chronic myocardial injury or possible late MI.
> 4 ng/L and <10 ng/L
The result is abnormal.  Cannot rule out MI.  Repeat testing in 2 hours.
> 10 ng/L
Consistent with MI if clinical characteristics correlate.
 
 
Beginning Wednesday, May 29, 2019, Parkview Health Laboratories will offer a new Vitamin B12 reflex HCYS and MMA test (EPIC Test Code: LAB3133), in addition to the current Vitamin B12 test.  Vitamin B12 values of 150-400 pg/mL will automatically reflex Homocysteine and Methylmalonic Acid testing.  This test may be indicated for the detection of subclinical or early Vitamin B12 deficiency.  Please refer questions to Dr. Qi Wang, Chemistry Technical Director, at 266-1641 or Ann Vick, Laboratory Chemistry Specialist, at 266-1587.
 
 
Changes effective 05/15/19 after 10am. Prothrombin time reference ranges: 9.4-11.3 seconds (currently: 9.2-11.2). APTT reference range: 22.7-31.7 seconds (currently 23.7-32.2).
The unfractionated heparin therapeutic range remains unchanged.
 
Questions may be directed to Dr. X. Wan at 266-1639 or Lisa Derck at 266-6085
 
  • 2679 Ova and Parasite: Concentrate and Permanent Smear
  • 5676 Microsporidia Exam
  • 10018 Cyclospora and Isospora Exam
  • 14348 Cryptosporidium Antigen, DVA
The laboratory is in the process of building each test in EPIC. If you have any questions please contact Carey Jacquay, Lab Manager Blood Bank/Microbiology/Sendouts at 260-266-1505
Beginning February 26th  a change will be made, when Group B screens are ordered. The provider must choose “YES” or “NO” to penicillin allergies to move forward with the order. This will allow the laboratory to proceed with appropriate susceptibility testing. Any questions can be directed to Carey Jacquay, Lab Manager Microbiology/Blood Bank/Sendout Testing, at 260-266-1505, or Landers Barber, Lab Lead Microbiology at 260-266-1593.
On Wednesday, March 6, 2019, the Parkview Health Laboratories will begin calculating the eGFR using the CKD-EPI equation.
The reference range remains >60, but patient results will be reported as numeric values up to 120 mL/min/1.73m.
The equation still applies only to those >18 years of age.
There might be a slight one-time shift in eGFR value with the transition to the CKD-EPI equation.
Please contact Dr. Qi Wang, Pathologist, at 266-1641, or Richard Brown, Laboratory Chemistry Specialist, at 266-6083.
January 28, 2019
On Tuesday, February 26, 2019, the Parkview Health Laboratories will change the Glucose reference range for all patients >1 day of age to 70-99 mg/dL.
Please contact Dr. Karen Wan, Pathologist, at 266-1639, or Richard Brown, Laboratory Chemistry Specialist, at 266-6083.
 

Beginning January 28, 2019, Parkview Health Laboratories will report Anion Gap with all lab orders containing an electrolyte panel.  Anion Gap will be reported with a normal reference range of 9-16 mmol/L.  Please refer questions to Ann Vick, Lab Chemistry Specialist, at 266-1587 or Dr. Qi Wang, Chemistry Technical Director, at 266-1641.

On Tuesday, January 29, 2018, the Parkview Health Laboratories will change the TSH reference range to 0.25-4.50 uIU/mL.
Please contact Dr. Karen Wan, Pathologist, at 266-1639, or Richard, Brown, Laboratory Chemistry Specialist, at 266-6083.

Hepatitis B Surface Antibody Results
Effective January 10, 2019, Hepatitis B Surface Antibody (HBsAb) results will contain both a quantitative value and a qualitative interpretation. 
This change is being made to allow providers to better correlate HBsAb results to WHO and CDC recommendations for interpretation of HBsAb immunity. 
Please refer questions to Ann Vick, Chemistry Specialist, at 266-1587 or Dr. Qi Wang, Chemistry Technical Director, at 266-1641.
 
Currently receiving the Green Capped Carey Blair Vial  
Sometime between now and February 1st will begin receiving the new
Orange Capped Fecal Swab Kit 
 
Parkview health will be requesting that patients discontinue high dose Biotin use for 48 hours prior to certain laboratory chemistry testing. Biotin peaks in the blood stream between 1-2 hours after ingestion, and begins to rapidly clear from the body, so in more urgent situations, testing at 8 hours of discontinuation may be considered since the interference will be less than 15%. (The half-life of Biotin varies from 8-18 hours.) 
Biotin (a.k.a Vitamin B7 or Vitamin H) is found in over-the-counter multivitamins (low-doses) and hair/skin/nail care products. Biotin is also used in certain reagents that generate patient test results, so an excess of the OTC products (an unusually high dose) can cause a false result to be reported by the Laboratory.
When a patient is taking a multivitamin as directed on the package, he/she does not need to wait to have your blood drawn. Typical daily multivitamin (30-60 mcg of biotin) pose no risk of interference, in the Roche assays.
When a patient is taking a supplement for hair, skin, or nail care as directed on the package, he/she needs to wait 48 hours after the dose to get your blood drawn.
When a patient is taking Biotin, Vitamin B7, or Vitamin H by prescription from a physician, he/she needs to wait 48 hours after the dose to get your blood drawn.
 
o   Patients taking vitamin supplements containing high doses of biotin (>5 mg/day) may have falsely increased test results generated.
o   Patients taking vitamin supplements containing doses of >5 mg/day may have falsely decreased test results generated.
Please contact Dr. Karen Wan, Pathologist, at 266-1639, or Richard, Brown, Laboratory Chemistry Specialist, at 266-6083.
 
Cortisol Testing Changes
On June 6, 2018, the reference range for the Cortisol, 8AM Cushings, the reported portion of the Dexamethasone Suppression Cushing’s test, will change from the current 0.0-0.5 ug/dL to 0.0-1.8 ug/dL.
 
Coagulation Reference Range Changes, effective after 10 am. on Tuesday May 8, 2018.
   Prothrombin time reference range: 9.2 – 11.2 seconds (currently: 9.2-11.1).   Epic Test code: Lab320
  APTT reference range: 23.7-32.2 seconds (currently 23.6-32.6). Epic Test code: Lab325
The unfractionated heparin therapeutic range remains unchanged. For any questions please contact Dr. Karen Wan at 266-1639
 
 
Our blood supplies provide only products that are prestorage leukoreduced. These products have been termed “CMV-safe” and are an approved product for adult patients who are at risk for transfusion-transmitted CMV infection. It is not necessary to note “CMV reduced-risk” or “CMV-negative” on blood product orders.
 
Parkview Health Laboratories will continue to supply CMV-seronegative red blood cells and platelets for neonates and recipients of intrauterine transfusion only.
 
The daily recommended allowance for Biotin is 0.03 mg However, supplements containing high biotin levels may contain up to 20 mg of biotin for hair, skin, and nail benefits, and physicians may recommend up to 300 mg per day for conditions such as multiple sclerosis.
Patients taking Biotin at doses > 5 mg/day will see interference in IA tests that use biotin in the reaction. The chart below lists the Roche IA tests currently in use at Parkview Health Laboratories with the method used on the Roche instruments.
IA tests using a competitive reaction will show a falsely elevated result.
IA tests using a competitive reaction will show a falsely decreased result.
The degree of interference is dependent on the amount of biotin taken.
 
This screening assay utilizes a cut-off of 100 ng/mL for the detection of oxycodone and oxymorphone.  This screen should be used for medical purposes only.  Alternate confirmatory testing is available, as needed.  Additional details may be found in the lab test directory at http://lab.parkview.com.  For any questions please contact Dr. Karen Wan at 266-1639 or Richard Brown at 266-6083.
On Monday, February 12, 2018, the Parkview health Laboratories will change the Calcium reference range for adults to 8.5-10.3 mg/dl.
Please contact Dr. Karen Wan, Pathologist, at 266-1639, or Richard, Brown, Laboratory Chemistry Specialist, at 266-6083.
Beginning Oct 31, 2017, Parkview Health System Laboratories will implement a new Erythrocyte Sedimentation Rate Analyzer, the Alcor iSED. The iSED ESR analyzer is fully automated. following a three-minute mix cycle, the ESR result is available in 20 seconds.
This photometric rheoscope technology is unaffected by variables commonly associated with traditional ESR testing, such as mixing, temperature, timing compared to other Westergren methods. This technology is less likely to be affected by the low hematocrit levels as compared to other methodologies.
Thus, if the ESR is being used to follow the progress of a patient’s inflammatory disease, during treatment, there may be some variation from prior evaluations, and the patient may need to have a new baseline established.
Specimen collection criteria remains unchanged. Sample stability remains at 24 hours, refrigerated.
The male reference range will be revised. <=50 years of age: 0-15mm/hr (current 0-20mm/hr); >50 yrs. of age: 0-20mm/hr (current 0-25mm/hr). Female ranges do not change (<50 yrs = 0-20mm/hr, >50 yrs = 0-30mm/hr) .
Dr. Zhuang, Hematology Medical Director, 266-1644.
Parkview Health Laboratories has begun using a new manufacturer for our O&P kits.  With this change, you will notice that the light blue cap vial is now a gray cap vial.  Please utilize the new gray cap vial just as you would the old blue cap vial.  The pink and white caps vials will remain the same in color.  You will start to see this change with any new O&P kits that you request.  Please continue to use any current kits that you may have as long as they are not expired.  For any further questions, please contact Karen Irven at 260-266-1593.
Coagulation reference range changes, effective 5-17-2017 (after 10am). Prothrombin time reference range 9.2 – 11.1 seconds. APTT reference range 23.6 – 32.6 seconds. The unfractionated heparin therapeutic range remains unchanged.
If you have any questions, please contact Dr. Karen Wan at 266-1639.
Effective March 15, 2017, the Trauma Panel will include a Blood Alcohol (Ethanol) for all patients 12 years and older.  Orders on patients younger than 12 years of age will not include a blood alcohol.  For questions, please contact Dr. Karen Wan, Laboratory Pathologist, 266-1630, or Richard Brown, Laboratory Chemistry Specialist, 266-6083.
On March 21, 2017, four of Parkview Health Laboratories locations will begin reporting patient results for Chemistry testing using the Roche Cobas analyzers.
PRMC, PVH, PHH, and PWB will make this switch at 9AM. The other laboratory locations (PWH, PWR, PLH, and PNH) will move to the Roche analyzers over the next 3 months.  In addition to the change from Troponin I to Troponin T, there are some tests that have reference ranges that will change from what is currently being reported. The updated ranges are attached.
For questions, contact Dr. Karen Wan, Laboratory Pathologist, 266-1630, or Richard Brown, Laboratory Chemistry Specialist, 266-6083.
January 16, 2017
Effective January 24, 2017, Parkview Health Laboratories will begin offering Mycobacterium tuberculosis, PCR testing in house.  This test detects Mycobacterium tuberculosis complex DNA in raw expectorated sputum or concentrated sputum sediment prepared from induced or expectorated sputum. In specimens where Mycobacterium tuberculosis complex (MTB-complex) is detected, the test also detects the rifampin-resistance associated mutations of the rpoB gene.  This test is intended for use with specimens from patients for whom there is clinical suspicion of tuberculosis (TB) and who have received no anti-tuberculosis therapy, or less than three days of therapy. This test should always be used in conjunction with Acid Fast Bacilli culture, not as a replacement for the culture.  For any questions please contact Dr. Karen Wan at 266-1639, or Ann Vick at 266-1521.
Change in Microalbumin Testing
 
To be consistent with best practice, Parkview Laboratories are discontinuing the random Microalbumin, Semi-Quantitative dipstick test (MicralTM) on December 1, 2016.
The test will be replaced by the random Microalbumin, Quantitative Urine test (Test Code - UMALR) which includes a Microalbumin/Creatinine ratio.
Questions can be directed to Dr. Yi Zhuang, Medical Director, at 266-1644 or Lisa Derck at 266-6085
 
Red Blood Cell Folate Test Discontinued
Folate deficiency in the US  is exceedingly rare since FDA-mandatory folic acid supplementation  in grain beginning in the 1990’s. One recent estimate is ~0.1%.  Studies on the Parkview patient population show that less than 1% have abnormal serum or RBC folate levels.
A recent large scale review and a large study at Mayo Clinic support that serum folate and RBC folate are equivalent in the assessment and diagnosis of folate deficiency.
Effective 12-1-2016, RBC  folate testing will no longer be offered in house at Parkview Health Laboratories, but will be available as a send out test. The panels VBFOL  (vitamin B12, RBC folate and serum folate) and VBFLS (vitamin B12 with serum folate) will be inactivated.  Each test will be orderable as individual tests.
Ref: Am J Clin Nutr 2013;98:1041-7, Clin Chem Lab Med 2013;51(3):555-69, Red Cell Folate Testing. Mayo Hot Topics; Nov 2010.
For any questions please contact Dr. Craig McBride at 266-1637, or Rick Brown at 266-6083
 
Clostridium difficile Testing Criteria
The Microbiology Lab uses a sensitive and specific molecular amplification test to detect Clostridium difficile infection (CDI). Due to the sensitive nature of the test, it is not necessary to submit more than one specimen per week; specimens received in the lab within 7 days of previous testing will be rejected. CDI testing should be limited to those patients having clinically significant diarrhea (>=3 unformed stools within 24 hours). Formed stools will be rejected by the laboratory to help eliminate false positive results. Performing a test of cure is not recommended, as patients may remain positive after CDI has resolved. Stools collected within 10 days of a previous positive result will be rejected by the laboratory. If diarrhea returns after symptoms had previously resolved, testing is appropriate as treatment failure is possible.
For any questions please contact Dr. Craig McBride at 266-1637, or Karen Irven at 266-1593

Siemens, the manufacturer of our Vitamin D assay, has recently updated the Instructions for Use (IFU) for their 25-OH Vitamin D assay due to discrepancies in values when testing is performed on plasma versus serum. 
 
Because of this, effective immediately, plasma is no longer an acceptable alternate or add-on specimen for 25-OH Vitamin D testing.  This effects test code VD251 - Vitamin D, 25 Hydroxy
Coagulation test: D-Dimer result comment revision:
The D-Dimer test result comment has been revised to reflect manufacturer’s disclaimer regarding specificity and sensitivity claims. No changes have been made to reference range or interpretation.
New Comment: In excluding deep vein thrombosis (DVT) and pulmonary (PE): In a non-high clinical probability population, using a cutoff of 0.5 mg/L FEU, a normal (<0.5 mg/L FEU) result excludes deep vein thrombosis (DVT) and pulmonary (PE) effectively. (Negative predictive value is 96-100% and 97.5-100% respectively). In detecting DVT and PE: using a cutoff of 0.5 mg/L FEU, the sensitivity is 96-100% and 93.3-100% respectively and the specificity is 34.5% and 39.6% respectively.
 
 
Siemens Healthcare Diagnostics has announced that N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interfere with some reagents used on Parkview Health Laboratories instruments, causing falsely depressed results.
N-Acetylcysteine (NAC) interferes with Triglycerides reagent.
Metamizole interfere with Triglycerides, HDL and Uric Acid reagents.
Venipuncture should occur prior to N-Acetylcycteine (NAC) or Metamizole administration to due to the potential for falsely depressed results.
Please direct questions to Richard Brown, Chemistry Specialist, at 266-1521, or Dr Steven Wang, Clinical Pathologist, at 266-1640.
 
Cryptococcal Antigen Assay
Beginning June 16th  Cryptococcal Antigen Assay will be done by lateral flow methodology which will allow the Microbiology Department to run this test on all shifts.
This test may be run on CSF (Epic: Cryptococcal Antigen Screen Spinal Fluid) or serum (Cryptococcal Antigen Screen Serum) and will replace the current latex agglutination method (Epic: Cryptococcal Antigen Screen).
 
The Microbiology Department is now running two new molecular panels:
GI Panel
Epic Name: Gastrointestinal Pathogen Panel by BioFire PCR
Specimen: Stool placed in Cary Blair Vial (green top stool vial—HEMM #91915) within two hours. No endoscopy stool aspirates or rectal swabs.
TAT: Within 24 hours after receipt in the Microbiology Lab
Enteric Pathogens detected by PCR:
Bacteria: Campylobacter (C. jejuni/C. coli/C. upsaliensis), Clostridium difficile toxin A/B, Plesiomonas shigelloides, Salmonella, Vibrio (V. parahaemolyticus/V.vulnificus/V. cholerae), Yersinia enterocolitica, Diarrheagenic E. coli (Enteroaggregative E. coli (EAEC), Enteropathogenic E. coli (EPEC), Enterotoxigenic (ETEC) heat-labile (lt) and heat-stable (st) Enterotoxins , Shiga-like toxin-producing E. coli (STEC) including E. coli O157, Shigella/Enteroinvasive E. coli (EIEC).
Viruses: Adenovirus F 40/41, Astrovirus, Norovirus GI/GII, Rotavirus A, Sapovirus (Genogroups I, II, IV and V).
Parasites: Cryptosporidium, Cyclospora cayetanensis, Entamoeba histolytica, Giardia lamblia
Meningitis/Encephalitis Panel
Epic Name: Meningitis Encephalitis Pathogen Panel by BioFire PCR
Specimen: CSF from tap (no shunt fluid)
TAT: Within 4 hours after receipt in the Microbiology Lab
Meningitis/Encephalitis Pathogens detected by PCR:
Bacteria: Escherichia coli, Haemophilus influenzae, Listeria monocytogenes, Neisseria meningitidis, Streptococcus agalactiae, Streptococcus pneumoniae
Viruses:  Cytomegalovirus (CMV), Enterovirus, Herpes simplex virus 1 (HSV 1), Herpes simplex virus 2 (HSV 2), Human herpes virus 6 (HHV 6), Parechovirus, Varicella-zoster virus (VZV)
Fungi: Cryptococcus neoformans/gattii

Parkview Health Laboratories presently reflexes a Group A Strep Culture on all negative Rapid Strep A results. Beginning May 31st we will begin reflexing cultures on only those patients less than eighteen years of age. 

On June 1, 2016, PRMC Chemistry will begin Procalcitonin (PCT) testing. The specimen requirement will be 1 ml plasma from Lithium Heparin (Mint Green top PST) tube. Testing will be performed Monday-Sunday on all shifts.
The reference ranges are:
 
For questions, contact Janet Benoit, Laboratory Technical Manager, at 266-1505, Richard Brown, Laboratory Chemistry Specialist, at 266-1521, or Dr. Steven Wang, Laboratory Pathologist, at 266-1640.
 
Changes effective 5-17-16, Prothrombin time reference range 9.4-11.6 seconds, APTT reference range 23.8-33.8 seconds, INR upper reportable range >8.9.  If you have any questions please contact Dr. Cindy Nie at 266-1641.
On May 17, 2016, the CK and reflex CKMB will be removed from the Cardiac Stat Panel (test code CARDC). The CK or the CKMB (which includes CK & CKMB) can be ordered as needed. For questions, contact Janet Benoit, Laboratory Technical Manager, at 266-1505, Richard Brown, Laboratory Chemistry Specialist, at 266-1521, or Dr Steven Wang, Laboratory Pathologist, at 266-1640.
On February 28, 2017, Parkview Health Laboratories will begin converting Chemistry testing from the Siemens Dimension platform to the Roche Cobas platform.
The rollout of the Roche instruments will occur in 4 phases:
                Feb 28, PRMC and PVH will go live on the Roche instruments.
                March 14, PHH and PWB will go live.
                May 2, PWH and PWR will go live.
                May 23, PNH and PLH will go live.
During this period of time, there will be limited standardization of reference ranges between the Laboratories.
The reference range changes are in the process of being evaluated and will be posted as soon as they are established.
The most significant change will be the use the current Troponin I to the Roche Troponin T assay.
The diagnostic criteria for Troponin T is:
 
                Troponin T
                 0.01-0.09 ng/ml- Abnormal, undetermined significance, repeat testing and further testing may  be indicated according to clinical findings                 >0.09 ng/ml- Consistent with myocardial infarction, if clinical characteristics correlate
For further information or questions, please contact Karen Wan, Laboratory Pathologist, 266-1639, or Richard Brown, Laboratory Chemistry Specialist, 266-6083.
On February 28, 2017, Parkview Health Laboratories will begin converting Chemistry testing from the Siemens Dimension platform to the Roche Cobas platform.
The rollout of the Roche instruments will occur in 4 phases:
                Feb 28, PRMC and PVH will go live on the Roche instruments.
                March 14, PHH and PWB will go live.
                May 2, PWH and PWR will go live.
                May 23, PNH and PLH will go live.
During this period of time, there will be limited standardization of reference ranges between the Laboratories.
The reference range changes are in the process of being evaluated and will be posted as soon as they are established.
The most significant change will be the use the current Troponin I to the Roche Troponin T assay.
The diagnostic criteria for Troponin T is:
    Troponin T
For further information or questions, please contact Karen Wan, Laboratory Pathologist, 266-1639, or Richard Brown, Laboratory Chemistry Specialist, 266-6083.

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