May 2021: National Supply Shortage of Light Blue Coagulation Tubes

Special Communication

Light Blue Coagulation Tubes: National Supply Shortage – Update

There is a severe nationwide shortage of light blue sodium citrate blood collection tubes used for coagulation laboratory tests such as prothrombin time (PT), activated partial thromboplastin time (aPTT), fibrinogen, and D-dimer.

Currently, no other substitute tube is readily available for coagulation testing.

Given coagulation testing’s critical role in many areas of medicine and surgery, Cleveland Clinic is implementing several supply conservation measures, including:

  • Using a “no additive” tube as a waste tube (instead of a light blue tube) when collecting other blood specimens. 
  • Restricting light blue tubes for use in the ED only for coagulation testing rather than in a routine rainbow draw.

For Ordering Providers:

If a patient is not on anticoagulants or is not going to surgery:

Reconsider the need for routine coagulation testing or consider extending the interval between daily coagulation testing orders. 

If a patient is undergoing treatment with direct oral anti-Xa anticoagulants, such as apixaban or rivaroxaban:

Consider not ordering PT and APTT (they are usually normal in these patients and not helpful in anticoagulant management).  

Due to the severe nationwide shortage, the Robert J. Tomsich Pathology & Laboratory Medicine Institute has updated specimen collection quantity guidelines for 1.8 mL, 2.7 mL, and 3.5 mL light blue sodium citrate coagulation tubes. Refer to the table below for details.

Test Name

Order Code

# of 1.8 mL light blue tubes needed

# of 2.7 mL light blue tubes needed

# of 3.5 mL light blue tubes needed

Platelet Aggregation

12

8

7

Aspirin/Clopidogrel Resistance (Aggregation) Panel

4

3

3

Hypercoagulation Diagnostic Interpretive Panel

5

4

3

Lupus Anticoagulant Diagnostic Interpretive Panel

5

4

3

Platelet Function Screen

4

3

3

PTT Incubated Mixing Study

4

3

3

Cleveland Clinic Laboratories will communicate further updates when available.  Please continue to check our website or contact Client Services at 800.628.6816 for assistance.

Pathology Insights – Diagnosis of CD30+ T-cell Lymphoproliferative Disorders with Genevieve Crane, MD, PhD

Pathology Insights Video Series

Diagnosis of CD30+ T-cell Lymphoproliferative Disorders

Presented by Genevieve Crane, MD, PhD

The diagnosis of CD30+ T-cell lymphoproliferative disorders, including ALK+ and ALK-negative forms of anaplastic large cell lymphoma, can present challenges. These entities show overlapping morphologic and immunohistochemical features but can vary widely in terms of clinical aggression.

Dr. Genevieve Crane, Staff Hematopathologist at Cleveland Clinic, discusses clinical presentation, morphologic features, and emerging prognostic markers that may aid in diagnosis and clinical management.

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.

April 2021: Changes to AIDYSA, ENCSER, PARNEO, LAMBRT, & MYGRAV Panels

Special Communication

Changes to AIDYSA, ENCSER, PARNEO, LAMBRT, & MYGRAV Panels

Changes to Reference Ranges

Effective May 11, 2021.

These changes will affect interfaced clients.

Autoimmune Dysautonomia Evaluation, Serum (AIDYSA)

Remove:
• (MUSBND) ACh Receptor (Muscle) Binding Ab
• (PARGAD) GAD65 Ab Assay
• (VGKC) Neuronal (V-G) K+ Channel Ab
• N-Type Calcium Channel Ab
• P/Q-Type Calcium Channel Ab
• Striational (Striated Muscle) Ab
• Reflex (MUSMOD) Muscle modulating antibody
• Reflex (CASRFX) CASPR2-IgG CBA
• Reflex (CRMPSX) CRMP-5-IgG
• Reflex (LG1RFX) LGI1-IgG CBA
• Reflex (PURK2X) Purkinje Cell Cytoplasmic Ab Type 2

Add to Panel:
• (CASRFX) CASPR2-IgG CBA
• (CRMPSX) CRMP-5-IgG
• (LG1RFX) LGI1-IgG CBA
• (PURK2X) Purkinje Cell Cytoplasmic Ab Type 2

Autoimmune Encephalopathy Evaluation, Serum (ENCSER)

Remove:
• (GANG3) AChR Ganglionic Neuronal Ab, S
• N-Type Calcium Channel Ab
• P/Q-Type Calcium Channel Ab
• Reflex (MUSMOD) Muscle modulating antibody

Paraneoplastic Autoantibody Evaluation, Serum (PARNEO)

Remove:
• Striational (Striated Muscle) Ab
• N-Type Calcium Channel Ab
• Reflex (MUSMOD) Muscle modulating antibody

Add:
• Reflex (ACMFCS) AChR Modulating Flow Cytometry, S

Test Discontinuations

Effective May 11, 2021.

Myasthenia Gravis/Lambert-Eaton Syndrome (LAMBRT)

Reason:
Discontinued by reference lab (Mayo Clinic Laboratories)

Alternative Test:
Myasthenia Gravis (MG)/Lambert-Eaton Syndrome (LES) Evaluation, Serum (MGLESE)

Myasthenia Gravis Evaluation, Adult (MYGRAV)

Reason:
Discontinued by reference lab (Mayo Clinic Laboratories)

Alternative Test:
Myasthenia Gravis Evaluation with Muscle-Specific Kinase (MuSK) Reflex, Serum (MYSGRV)

Pathology Insights – Two Diagnoses in One Bone Marrow with Megan Nakashima, MD

Pathology Insights Video Series

Two Diagnoses in One Bone Marrow

Presented by Megan Nakashima, MD

Analysis of a bone marrow requires both careful morphologic examination as well as appropriate ancillary studies.

Dr. Megan Nakashima, Staff Hematopathologist at Cleveland Clinic, discusses a complicated bone marrow case involving a patient with thrombocytopenia, monocytosis, and diarrhea. After requiring the incorporation of molecular and immunophenotypic information, two diagnoses are reached.

In addition to this case, Dr. Nakashima reviews relevant changes in the WHO 2016 classification of myeloid and associated neoplasms.

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.

Restrictions to PSA and β-HCG, Plasma Add-On Orders

Special Communication

Restrictions to PSA and β-HCG, Plasma Add-On Orders

Due to a potential for falsely-increased results from carryover on analytical laboratory instrumentation, add-on orders for PSA and β-HCG, Plasma are restricted.

Tests affected:

Please refer to the Test Directory for more information.

• PSA (PSA)

• PSA, Free (PSATF)

• PSA, Screening (PSAS1)

• Beta HCG, Quantitative, Blood (HCGQT)

• Beta HCG, Quant Tumor Marker (BHCG)

Pathology Insights – Diagnosing Microinvasive Breast Cancer with Miglena Komforti, DO

Pathology Insights Video Series

Diagnosing Microinvasive Breast Cancer in a Background of Intraductal Carcinoma

Presented by Miglena Komforti, DO

In the breast, the pathologic diagnosis of a small focus of invasion can be quite challenging.

Dr. Miglena Komforti discusses the histopathologic findings, ancillary immunohistochemical stains, and clinical significance of microinvasive cancer of the breast.

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.

February 2021: Inhibin B – Changes to Reference Ranges

Special Communication

Inhibin B – Changes to Reference Ranges

Effective February 16, 2021, methodology and reference intervals for Inhibin B (INHIBB) will change.

Test results obtained with the new ANSH Ultra-Sensitive Inhibin B ELISA method and the previous Beckman Coulter Inhibin G Gen II ELISA method cannot be used interchangeably.

Beginning February 16 through May 16, 2021, specimens will be analyzed with both methods to establish a new baseline for individual patient results. Results from the previous method and reference intervals will be posted in a comment on the patient’s chart.

This change increases the detection of inhibin B in all clinically relevant cases and expands the testing range to improve sensitivity.

Additional details are available in the February 2021 Technical Update.

Changes to Reference Ranges

Effective February 16, 2021.

Inhibin B (INHIBB)

Female

1 day – 12 years:
1 – 182 pg/mL

13 – 41 years (regular cycle, follicular phase):
8 – 223 pg/mL

42 – 51 years (regular cycle, follicular phase):
1 – 107 pg/mL

51 – 76 years (postmenopausal):
1 – 11 pg/mL

Male

< 15 days:
68 – 373 pg/mL

15 days – 6 months:
42 – 516 pg/mL

7 months – 7 years:
24 – 300 pg/mL

8 – 30 years:
47 – 383 pg/mL

31 – 72 years:
10 – 357 pg/mL

Methodology

ANSH ultrasensitive Inhibin B ELISA method
formerly Beckman Coulter Inhibin B Gen II ELISA method

Pathology Insights – Diagnosis of Metastatic Renal Cancer with Sean Williamson, MD

Pathology Insights Video Series

Diagnosis of Metastatic Renal Cancer

Presented by Sean Williamson, MD

Pathologic diagnosis can be challenging in the setting of poorly-differentiated and metastatic renal cancer.

Dr. Sean Williamson, Director of Genitourinary Pathology at Cleveland Clinic, discusses immunohistochemical and molecular testing used to help confirm the diagnosis.

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.

November 2020: Temporarily Unavailable – Stool Gastrointestinal Panel by PCR

Special Communication

Temporarily Unavailable: Stool Gastrointestinal Panel by PCR

Beginning November 13, 2020, Stool Gastrointestinal Panel by PCR (STGIPR) testing is temporarily unavailable to order from CCL.

Cleveland Clinic Laboratories is experiencing severe supply constraints for Stool Gastrointestinal Panel by PCR (STGIPR) testing. These shortages impact laboratories nationwide, resulting in the inability to identify a reference laboratory to forward this testing.

Alternative Testing Options

The tests listed below cover the range of pathogens detected in the Stool Gastrointestinal Panel by PCR (STGIPR) test. Depending on clinical circumstances and judgment, various combinations of these tests may serve as an appropriate substitution for STGIPR:

Test Code

Components

Performing Lab

STLPCR

Salmonella spp., Shigella spp., Campylobacter jejuni/coli, and Shiga-toxin (stx1 and stx2) genes

CCL

OVAPSC

Giardia lamblia and Cryptosporidium species

CCL

CRYSPO

Cryptosporidium, Cyclospora, and Cystoisospora sp.

CCL

OVAP

Cryptosporidium and Giardia

CCL

CDPCR

C. difficile toxin B gene

CCL

EROTA

Rotavirus antigen

CCL

VIBCUL

Vibrio

CCL

YERCUL

Yersinia

CCL

NORPCR

Norovirus 1 & 2

ARUP

SADNO

Adenovirus antigen

Focus

COVID-19: Supply Constraints Affecting Enteric Bacterial Panel by PCR Testing

Special Communication

Supply Constraints Affecting Enteric Bacterial Panel by PCR Testing

Due to supply constraints related to COVID-19, supplies for Enteric Bacterial Panel by PCR (STLPCR) testing are in extremely limited supply.

While supplies are constrained, culture and antigen testing will be used in place of PCR testing to interrogate specimens for the same pathogens as STLPCR: Campylobacter, Salmonella, Shigella, and Shiga toxin-producing E. coli (STEC/EHEC).

Cleveland Clinic Laboratories will temporarily cancel and credit any STLPCR test requests, then substitute clinically-equivalent culture and antigen testing.

The associated CPT codes for these substitutions are:

• 87449 (x 2)
• 87045