Author: Admin

May 2023: COVID-19 Testing – CPT Code Update

Immediate Test Change

COVID-19 Testing – CPT Code Update

Effective May 11, 2023.

In accordance with recent guidance provided by the Department of Health and Human Services on May 9, 2023, the CPT code associated with COVID-19 testing will change.

Beginning May 11, 2023, the CPT code is changing as a result of the end of the COVID-19 Public Health Emergency.

The new CPT code will display in the Test Directory starting May 11, 2023.

COVID-19 Testing

New CPT Code
87635 (previous: U0003)

Additional Information
For more information, please refer to HHS’s Fact Sheet: End of the COVID-19 Public Health Emergency.

Special Communications
Immediate Test Changes
News & Updates

May 2023: Changes to Legionella Diagnostic Testing (LEGPCR)

Clinical Updates

Changes to Legionella Diagnostic Testing (LEGPCR)

Effective May 2, 2023.

Improvements to Cleveland Clinic Laboratories’ Legionella PCR assay will result in the discontinuation of most Legionella cultures.

Beginning May 2, 2023, Legionella pneumophila PCR (LEGPCR) will include additional DNA targets for Legionella, including species other than Legionella pneumophila, and a target specific for Legionella pneumophila serogroup 1.

This assay design is modeled after the U.S. Centers for Disease Control & Prevention’s assay.1

Legionella pneumophila PCR (LEGPCR)

Specimen Requirements
Lower respiratory samples, including bronchoalveolar lavage (BAL) and sputa, will continue to be the acceptable specimen types for PCR.

Results
Possible interpretations of test results include:

  • Legionella pneumophila Serogroup 1 Detected
  • Legionella pneumophila (not Serogroup 1) Detected
  • Legionella species (not pneumophila) Detected

Additional Updates
Beginning May 23, 2023, routine culture for Legionella spp. (LEGCUL) will be discontinued, but culture will reflexively be performed on any sample with detectable Legionella DNA by PCR.

Note: There is no change to Legionella urine antigen (LEGUAG) testing.

Reference

1 Benitez AJ, Winchell JM. Clinical application of a multiplex real-time PCR assay for simultaneous detection of Legionella species, Legionella pneumophila, and Legionella pneumophila serogroup 1. J Clin Microbiol. 2013 Jan;51(1):348-51. doi: 10.1128/JCM.02510-12. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3536254/pdf/zjm348.pdf

Special Communications
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April 2023: Updates to H. pylori Urea Breath Test

Immediate Test Change

Updates to H. pylori Urea Breath Test (HPYLBR)

Effective May 2, 2023.

Updated Test

Helicobacter pylori Breath Test (HPYLBR)

Effective May 2, 2023, the Immunopathology Laboratory section of Cleveland Clinic Laboratories will provide a new H. pylori urea breath test.

The qualitative test, based on infrared spectroscopy using 13C, is an aid in diagnosing active infection with Helicobacter pylori and post-treatment monitoring in adult and pediatric patients ages 3-17 years old.

Changes to Specimen Collection

Specimens must be collected with the Meridian Bioscience collection kit; otherwise, testing will be canceled.

Collection Kits

The BreathID® Hp® Two test requires specimen collection with the BreathID® IDkit Hp® Two kit.

One box contains five kits. Each kit contains:

  • (1) Blue baseline breath collection bag
  • (1) Grey post-ingestion breath collection bag
  • 75mg 13C-urea tablet
  • 4.3g package of Citrica (citric acid)
  • Straw
  • Drinking cup
  • User guide
  • (4) Labels
  • Sample transport bag
  • Package insert

Order BreathTek® Urea Breath Test Kits
Collection Instructions

Test Overview

Test Name

Helicobacter pylori Breath Test

Test Code

HPYLBR

CPT Code

83013

Methodology

13C Infrared Spectroscopy

Specimen Type

1 baseline (blue) and 1 post-dose (gray) breath sample bag collected with a BreathID® IDkit Hp® One kit

Stability

Ambient
14 days

Refrigerated
Unacceptable

Frozen
Unacceptable

Reference Range

Negative

Clinical Information

The Urea Breath Test is used as an aid in the diagnosis of current infection with Helicobacter pylori.

Limitations

Despite very high specificity, false positive results may occur due to other gastric organisms, such as H. heilmanni, as well as in patients with hypo- or achlorhydria.

False-negative results may occur in patients who have received antibiotics, proton pump inhibitors, or bismuth preparations.

Clinical correlation is required.

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2024 Cleveland Clinic Multispecialty Pathology Symposium – Register Now!

Clinical Updates

2024 Cleveland Clinic Multispecialty Pathology Symposium

January 26-28, 2024  |  Wynn Las Vegas

Overview

This pathology symposium will focus on practical discussions of commonly encountered problems in surgical pathology. The goal is to provide useful tips that the speakers utilize in their own practice at the microscope. We aim to address and discuss common problems and avoid an undue focus on esoterica.

In this course, renowned subspecialists who are highly sought-after for their teaching skills will cover a broad spectrum of cases, including genitourinary pathology, thoracic pathology, gastrointestinal and soft tissue pathology, gynecologic cancer, and breast pathology.

Practicing pathologists, fellows, and residents who attend will maintain, develop, and increase their knowledge, competence, and professional performance, with the intent to improve diagnosis and positively impact patient care.

Target Audience: Pathologists, Pathology Residents & Fellows

This activity has been approved for AMA PRA Category 1 credit™.

Register Now!

Symposium Co-Directors

Sanjay Mukhopadhyay, MD

Sean Williamson, MD

Sean Williamson, MD

Faculty Presenters

John Goldblum, MD

John Goldblum, MD

Amy Joehlin-Price, MD

Amy Joehlin-Price, MD

Andrew Sciallis, MD

Andrew Sciallis, MD

Agenda

Friday

Friday, January 26, 2024

7:00 am           Registration, Continental Breakfast, and Exhibits

8:00 am           Welcoming Remarks – Sean Williamson, MD, and Sanjay Mukhopadhyay, MD

 

Genitourinary Pathology

8:10 am           Pattern Based Approach to Renal Cell Tumors – Sean Williamson, MD

9:00 am           What’s New in Prostate Cancer Pathology? – Sean Williamson, MD

9:45 am           Question & Answer Period

10:00 am         Refreshment Break and Exhibits

 

GI and Soft Tissue Pathology

10:30 am         Barrett’s Esophagus and BE-related Dysplasia: A Practical Approach to the Most Common Problems – John Goldblum, MD

11:15 am         IBD and IBD-related Dysplasia with a Focus on Unusual Variants of Ulcerative Colitis – John Goldblum, MD

12:00 pm         Question & Answer Period

 

12:15 pm         Lunch served at Wynn Las Vegas

 

Pulmonary Pathology

1:15 pm           The New, the Exciting, and the Annoying. Updates in Lung Cancer in 2023 – Sanjay Mukhopadhyay, MD

2:00 pm           What I Learned from Mistakes in Thoracic Pathology – Sanjay Mukhopadhyay, MD

2:45 pm           Questions & Answer Period

3:00 pm           Refreshment Break and Exhibits

 

Gynecologic Pathology

3:30 pm           Practical Staging in Endometrial Cancer: Important Details Made Easier – Amy Joehlin-Price, MD

4:15 pm           Classifying High Grade Endometrial Cancer: When Histotype Matters and Why – Amy Joehlin-Price, MD

5:00 pm           Question & Answer Period

 

5:15 pm           Adjourn

Saturday

Saturday, January 27, 2024

7:15 am           Continental Breakfast and Exhibits

 

Breast Pathology

8:00 am           Problematic Intraductal Breast Lesions – Andrew Sciallis, MD

8:45 am           Papillary Neoplasms of the Breast – Andrew Sciallis, MD

9:30 am           Question & Answer Period

 

9:45 am           Refreshment Break and Exhibits

 

Pulmonary Pathology

10:15 am         10 Lung Tumors You Must Have in Your Toolbox – Sanjay Mukhopadhyay, MD

11:00 am         Mesothelioma and Thymoma: Tips and Tricks to Simplify Your Life – Sanjay Mukhopadhyay, MD

11:45 am         Question & Answer Period

 

12:00 pm         Lunch – On Your Own

 

GI and Soft Tissue Pathology

1:30 pm           Common Problems in Diagnosis and Terminology in Colorectal Polyps – John Goldblum, MD

2:15 pm           The Trouble with Fat: How to Handle the Most Common Lipomatous Tumors – John Goldblum, MD

3:00 pm           Question & Answer Period

 

3:15 pm           Refreshment Break and Exhibits

 

Genitourinary Pathology

3:45 pm           What’s New in Bladder Cancer Pathology? – Sean Williamson, MD

4:30 pm           Common Challenges in Testicular Tumors – Sean Williamson, MD

5:15 pm           Question & Answer Period

 

5:30 pm           Adjourn

Sunday

Sunday, January 28, 2024

7:15 am           Continental Breakfast and Exhibits

 

Gynecologic Pathology

8:00 am           Ovarian Frozen Section Pathology: How What You Say Affects What They Do – Amy Joehlin-Price, MD

8:45 am           Vulvar Squamous Cell Carcinoma: Why We’re Making It More Complicated and How to Think about It Simply – Amy Joehlin-Price, MD

9:30 am           Question & Answer Period

 

9:45 am           Refreshment Break and Exhibits

 

Breast Pathology

10:15 am         Challenging Spindle Cell Lesions of the Breast – Andrew Sciallis, MD

11:00 am         Fibroepithelial Lesions of the Breast: An Overview – Andrew Sciallis, MD

11:45 am         Question & Answer Period

 

12:00 pm         Closing Remarks – Sean Williamson, MD, and Sanjay Mukhopadhyay, MD

 

12:15 pm         Adjourn

Special Communications
Immediate Test Changes
News & Updates

December 2022: Changes to Acceptable Tube Type for Azole Anti-Fungal Therapeutic Drug Monitoring

Special Communication

December 2022: Changes to Acceptable Specimen Containers for Azole Anti-Fungal Therapeutic Drug Monitoring

Effective December 20, 2022

Plasma collected in Green Lithium Heparin Tubes will no longer be accepted for azole anti-fungal therapeutic drug monitoring tests.

Please collect samples for Azole Anti-Fungal Therapeutic Drug Monitoring tests in Red (serum) No Additive Tubes, centrifuge, and transfer the serum to an aliquot tube.

Tests Affected:

  • Fluconazole (FLUC)
  • Isavuconazole (ISACON)
  • Itraconazole (ITRAC)
  • Posaconazole (POSACN)
  • Voriconazole (VORCON)

Updated Specimen Requirements

Specimen Type:
Serum

Volume:
0.5 mL

Collection Container:
Red (Serum) No Additive Tube

Transport Temperature:
Refrigerated

Do not use gel separator tubes.

Special Communications
Immediate Test Changes
News & Updates

Pathology Insights: Tumors of the Lung with Sanjay Mukhopadhyay, MD

Pathology Insights Video Series

Tumors of the Lung

Presented by Sanjay Mukhopadhyay, MD

In this video, an expert pulmonary pathologist and director of Cleveland Clinic’s Pulmonary Pathology service briefly covers all lung tumor types – including all the subtypes of lung cancer – listed in the new (2021) World Health Organization classification. Dr. Mukhopadhyay then describes the primary pathologic features of these tumors with high-quality pathology images provided in most cases.

This video should be helpful for patients, surgeons, pulmonologists, oncologists, pathologists, residents, and medical students.

As part of our educational mission for our clients and communities, Cleveland Clinic Laboratories presents the Pathology Insights video series.
These short videos break down information about interesting pathology cases to better inform doctors, laboratory staff, patients, or anyone interested in the field of pathology. Each episode features important cases, methods, and practices that are personally presented by our staff pathologists.

August 2022: Changes to C Telopeptide, Beta Cross Linked (CTELO)

Special Communication

August 2022: Changes to C Telopeptide, Beta Cross Linked (CTELO)

Effective September 6, 2022

C Telopeptide, Beta Cross Linked (CTELO)

Specimen Requirements

Changes to Specimen Requirements

Specimen Type:
Serum

Volume:
1 mL

Minimum Volume:
0.5 mL

Collection Container:
Gold Serum Separation Tube (SST)

Transport Temperature:
Frozen, critical

A morning fasting specimen is preferred.

Separate specimens must be submitted when multiple tests are ordered.

Collection Information:
Allow the tube to sit for 15-20 minutes at room temperature to form a clot. Centrifuge and separate serum from cells ASAP or within 2 hours of collection. Transfer serum to a standard aliquot tube.

Alternative Specimen

Alternative Specimen Type:
Plasma

Volume:
1 mL

Minimum Volume:
0.5 mL

Collection Container:
Lavender K2EDTA Tube

Transport Temperature:
Frozen, critical

Do not draw serum gel tubes for this test.

Collection Information:
Centrifuge and separate plasma from cells ASAP or within 2 hours of collection. Transfer plasma to a standard aliquot tube.

Reference Ranges

Changes to Reference Ranges

Male

6 Months to 6 Years:
500 – 1700 pg/mL

7 to 9 Years:
522 – 1682 pg/mL

10 to 12 Years:
553 – 2071 pg/mL

13 to 15 Years:
485 – 2468 pg/mL

16 to 17 Years:
276 – 1546 pg/mL

18 to 29 Years:
238 – 1019 pg/mL

30 to 39 Years:
225 – 936 pg/mL

40 to 49 Years:
182 – 801 pg/mL

50 to 59 Years:
161 – 737 pg/mL

60 to 69 Years:
132 – 752 pg/mL

70 to 99 Years:
118 – 776 pg/mL

Special Communications
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September 2022: Best Practice for Detecting Hyperhomocysteinemia – Homocysteine Testing—Not MTHFR Genotyping

Best Practice for Detecting Hyperhomocysteinemia: Homocysteine Testing—Not MTHFR Genotyping

There is no conclusive evidence supporting the clinical value of MTHFR polymorphism genotyping.

Practice guidelines from multiple professional societies agree that MTHFR polymorphism genotyping should not be ordered as part of clinical evaluation.

If there is a clinical concern regarding hyperhomocysteinemia, Cleveland Clinic Laboratories recommends Homocysteine testing (HOMCYS) in place of MTHFR genotyping. Homocysteine testing is less expensive, generates a result more quickly, and provides additional actionable information for patient management.

Best Practice

If there is a clinical concern regarding hyperhomocysteinemia (HCC), Cleveland Clinic Laboratories recommends Homocysteine testing (HOMCYS) in place of MTHFR genotyping

Homocysteine (HOMCYS)

Upcoming Changes

November 15, 2022: MTHFR genotyping (MTHFRM) will no longer be available as a send-out test, even if ordered as a miscellaneous test.

March 16, 2021: Homocysteine testing (HOMCYS) will replace MTHFR genotyping at Cleveland Clinic.

HOMCYS Test Overview

Homocysteine (HOMCYS) Test Details

Test Name

Homocysteine

Test Code

HOMCYS

CPT Code

83090

Performing Laboratory

Cleveland Clinic Laboratories

FDA Compliance

In Vitro Diagnostic (IVD)

Methodology

Enzymatic

Days Performed

Sun – Sat

Turnaround Time

8 hours

Specimen Requirements

Type:
Plasma

Volume:
1 mL

Specimen Container:
Light Green Lithium Heparin Plasma Separator Tube (PST)

Transport Temperature:
Refrigerated

Place specimen on ice after draw.

Alternative Specimen Requirements

Type:
Serum

Volume:
1 mL

Specimen Container:
Gold Serum Separation Tube (SST)

Transport Temperature:
Refrigerated

Place specimen on ice after draw.

Special Instructions

• Centrifuge and separate plasma/serum from cells less than one hour after collection.

• If collected in a non-gel separator tube, centrifuge and transfer plasma/serum to a CCL tube and refrigerate.

Stability

Ambient:
4 days

Refrigerated:
4 weeks

Frozen:
10 months

Reference Interval

18-99 Years – Normal:
<15.1 umol/L

MTHFR: Lack of Evidence

Lack of Evidence for MTHFR Polymorphism Genotyping

Recommendation: Test Plasma Homocysteine Levels

Download this Overview (PDF)

There is no conclusive evidence supporting the clinical value of MTHFR polymorphism genotyping.

If there is a clinical concern regarding hyperhomocysteinemia, Cleveland Clinic Laboratories recommends Homocysteine (HOMCYS) testing.

• Multiple practice guidelines agree that MTHFR polymorphism genotyping should not be ordered as part of a clinical evaluation.

• A cheaper, faster, and more accurate way to test for hyperhomocysteinemia is to measure plasma homocysteine levels.

• If plasma homocysteine levels are high, patients can supplement with vitamins such as B6, B12, folate, and folic acid.

• If plasma homocysteine levels are normal, no treatment is indicated—even if there is an MTHFR variant.

Plasma homocysteine levels determine clinical management, regardless of the MTHFR genotype result.

Professional Societies with MTHFR Polymorphism Testing Guidelines:

After reviewing these guidelines,
Cleveland Clinic’s RT-PLMI Section of Molecular Pathology, Genomic Medicine Institute, and Laboratory Stewardship Committee agreed to discontinue MTHFR polymorphism genotyping.

Background

The MTHFR gene (OMIM: 607093) on 1p36.22 encodes the 5,10-methylenetetrahydrofolate reductase enzyme, which converts 5,10-methylenetetrahydrofolate to 5-methyltetrahydrofolate, the primary circulatory form of folate. This enzyme is also involved in the metabolism of the amino acid, homocysteine. A deficiency of the enzyme can lead to HHC.

Polymorphisms are common variants within a gene that do not necessarily affect its function, unlike pathogenic or disease-causing variants. Two commonly tested polymorphic variants in MTHFR are:

c.665C>T* (p.Ala222Val)
*Historically referred to as C677T, the ‘thermolabile’ variant

c.1286A>C (p.Glu429Ala)

These variants are so common that approximately 25% of individuals with Hispanic ancestry and 15% of North Americans with European ancestry have two copies of c.665C>T.

The presence of two copies of c.665C>T (homozygosity) may result in decreased MTHFR enzyme activity and mild HHC. Neither of these MTHFR polymorphisms causes severe MTHFR deficiency (<20% enzyme activity).

References

1. Lack of Evidence for MTHFR Polymorphism Testing. ACMG Practice Guideline. Genet Med. 2013;15(2):153-6.
2. Inherited Thrombophilias in Pregnancy. ACOG Practice Bulletin. No. 197. American College of Obstetricians and Gynecologists. Obstet Gynecol. 2018;132:e18–34.
3. Levin BL, Varga E. MTHFR: Addressing Genetic Counseling Dilemmas Using Evidence-Based Literature. J Genet Counsel. 2016;25:901-11.
4. Choosing Wisely® Initiative https://www.choosingwisely.org/
5. Eng, C. A Genetic Test You Don’t Need: Testing MTHFR is usually unnecessary. Cleveland Clinic Health Essentials. https://health.clevelandclinic.org/a-genetic-test-you-dont-need/. Accessed November 19, 2020.

Updating Best Practices

Updating Best Practices

Cleveland Clinic Laboratories encourages providers to incorporate Homocysteine testing (HOMCYS) into their practice in place of MTHFR genotyping.

November 15, 2022: MTHFR genotyping will no longer be available as a send-out test, even if ordered as a miscellaneous test.

March 16, 2021: MTHFR genotyping will no longer be performed in-house at Cleveland Clinic.

Special Communications
Immediate Test Changes
News & Updates

Pathology Insights: Update on Small Round Cell Tumors with Scott Kilpatrick, MD

Pathology Insights Video Series

Update on Small Round Cell Tumors with Scott Kilpatrick, MD

Presented by Scott Kilpatrick, MD

In this video, Scott Kilpatrick, MD, Director of Orthopedic Pathology at Cleveland Clinic, provides historical context and WHO updates on the evolving classification of undifferentiated round cell sarcomas, including Ewing sarcoma and the so-called Ewing family of sarcomas.

As part of our educational mission for our clients and communities, Cleveland Clinic Laboratories presents the Pathology Insights video series.
These short videos break down information about interesting pathology cases to better inform doctors, laboratory staff, patients, or anyone interested in the field of pathology. Each episode features important cases, methods, and practices that are personally presented by our staff pathologists.