Author: Admin

Download Secure Messaging Instructions (.pdf)

February 2022: Epic Beaker LIS Go-Live at Cleveland Clinic

On Saturday, February 26, 2022, Cleveland Clinic Laboratories will transition to the Epic Beaker laboratory information system (LIS).

Beaker replaces Sunquest and CoPath, allowing pathology and laboratory medicine test orders, results, and laboratory data to coexist within one platform at Cleveland Clinic.

Clients anticipated to be affected by this change have already been notified by a CCL representative.

If you or your organization has not been contacted, no action is required at this time.

Following the February 26 go-live:
If you experience issues placing orders or receiving test results, please contact your CCL Account Manager immediately or call Client Services at 800.628.6816 for assistance.

New! Secure Messaging

Following the implementation of Beaker, Cleveland Clinic Laboratories will begin sending daily client reports via Secure Messaging. This new system enables safe, protected transferring of sensitive information.

Recipients can only read a Secure Message by logging into the Secure Messaging portal. Reports will be available within the Secure Messaging portal for ten days. Requests for information older than ten days can be placed through Technical Sales Support.

January 2022: Changes to Specimen Requirements, Reference Ranges, and More

Special Communication

January 2022: Changes to Specimen Requirements, Reference Ranges, and More

All changes effective February 22, 2022.

Changes to Specimen Requirements

AMYISO

Amylase Isoenzymes (AMYISO)

Alternative Specimen Requirements

Specimen Type:
Plasma

Volume:
1 mL

Minimum Volume:
0.5 mL

Collection Container:
Light Green Lithium Heparin PST
Note: Plasma specimens in Sodium Heparin tubes are no longer acceptable.

Transport Temperature:
Refrigerated

Additional Information:
Remove plasma ASAP or within 2 hours of collection.

BHCG

Beta hCG Quant Tumor Marker (BHCG)

Alternative Specimen Requirements

Specimen Type:
Plasma

Volume:
1 mL

Minimum Volume:
0.4 mL

Collection Container:
Light Green Lithium Heparin PST
Note: Plasma specimens in Sodium Heparin tubes are no longer acceptable.

Transport Temperature:
Refrigerated

Additional Information:
Separate plasma from cells within 2 hours of collection and transfer to a standard aliquot tube.

CTELO

C Telopeptide, Beta Cross Linked (CTELO)

Alternative Specimen Requirements

Specimen Type:
Plasma

Volume:
1 mL

Minimum Volume:
0.5 mL

Collection Container:
Lavender K₂EDTA

Transport Temperature:
Refrigerated

Additional Information:
Morning fasting specimen preferred.

Patient Prep:
For patients receiving therapy with high biotin doses (e.g. greater than 5 mg/day), the specimen should not be drawn until at least 8 hours after the last biotin administration.

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

HIVNGS

HIV 1 Drug Resistance by Next Generation Sequencing (HIVNGS)

Specimen Requirements

Specimen Type:
Plasma

Volume:
3 mL

Minimum Volume:
2.5 mL

Collection Container:
Lavender K₂EDTA

Transport Temperature:
Frozen

Additional Information:
Separate plasma from cells within 24 hours and transfer plasma to a standard aliquot tube. Please submit the most recent viral load and test date, if available.

T3U

T3, Uptake (T3U)

Alternative Specimen Requirements

Specimen Type:
Plasma

Volume:
1 mL

Minimum Volume:
0.5 mL

Collection Container:
Light Green Lithium Heparin PST
Note: Plasma specimens in Sodium Heparin tubes are no longer acceptable.

Transport Temperature:
Refrigerated

Additional Information:
Separate plasma from cells ASAP or within 2 hours of collection and transfer to a standard aliquot tube.

Changes to Reference Ranges

AMYISO

Amylase Isoenzymes (AMYISO)

Total Amylase

13-99 Years:
28 – 100 U/L

Pancreatic Amylase

18-99 Years:
13 – 53 U/L

BTSTFC

Bioavailable Testosterone/SHBG, Female & Child (BTSTFC)

Sex Hormone Binding Globulin – Female

18-49 Years:
25 – 122 nmol/L

50-99 Years:
17 – 125 nmol/L

Sex Hormone Binding Globulin – Male

18-49 Years:
17 – 56 nmol/L

50-99 Years:
19 – 76 nmol/L

CKISO

CK Isoenzymes (CKISO)

Creatine Kinase – Female

18 Years and Older:
26 – 192 U/L

Creatine Kinase – Male

18 Years and Older:
39 – 308 U/L

CTELO

C Telopeptide, Beta Cross Linked (CTELO)

Female, Premenopausal:
25 – 573 pg/mL

SCHIST

Schistosoma IgG Ab (SCHIST)

Less than 9 U:
Negative – No significant level of Schistosoma IgG antibody detected.

9 – 11 U:
Equivocal – Recommend repeat testing in 2-4 weeks with a fresh sample.

Greater than 11 U:
Positive – IgG antibodies to Schistosoma detected, which may suggest current or past infection.

Changes to Test Build

CYP2C19 – Cytochrome P450 2C19 (2C19CY)

Components Affected

Add component CYP2C19 Phenotype

Test Discontinuations

von Willebrand Disease, Type 2A (VWF) Sequencing Exon 28 with Reflex to 9 Exons (VWFE28)

Reason for Discontinuation:
No longer offered by vendor

Alternative Test:
von Willebrand Disease (VWF) Sequencing (VWFSEQ) – Available 02/26/22

NAbFeron Ab (NABFAB)

Reason for Discontinuation:
No longer offered by vendor

December 2021: Test Delay – HIV-1 Antibody Confirmation by Western Blot (HIV1CO)

Immediate Test Change

Test Delay – HIV-1 Antibody Confirmation by Western Blot (HIV1CO)

Delayed Test

HIV-1 Antibody Confirmation by Western Blot (HIV1CO)

Effective December 14, 2021.

HIV-1 by Western Blot (HIV1CO) testing performed by CCL’s partnered reference laboratory is experiencing extended test delays caused by a nationwide shortage of testing kits.

These delays are anticipated to affect HIV1CO testing until February 2022.

Alternative Test

HIV-1/2 Antibody Confirmatory (HIV12M)

Test name:
HIV-1/2 Ab Confirmatory

Order code:
HIV12M

Specimen type:
Serum

Collection container:
Gold Serum Separation Tube (SST)

Alternative specimen type:
Plasma

Alternative collection container:
Lavender K₂EDTA Tube

Transport temperature:
Refrigerated

October 2021: Limited Availability of Amies Dual Swabs, ESwabs™

Special Communication

Limited Availability of Amies Dual Swabs, ESwabs™

Intermittent supply chain interruptions are anticipated for Amies Dual Swabs and ESwabs™ through early 2022.

As a result, ordering quantities are limited.

There may also be delays in fulfilling requests for these items, or an approved alternative swab may be provided instead.

If you have any questions, please contact your CCL Account Manager or Client Services.

October 2021: TFTEST – Temporary Change in Performing Send-out Laboratory

Immediate Test Change

TFTEST – Temporary Change in Performing Send-out Laboratory

November 4, 2021 – Update: Testosterone, Total and Free, Serum (TFTEST) has resumed being performed by Mayo Clinic Laboratories, the test’s original standard reference laboratory.

This change occurs automatically for TFTEST samples received by Mayo Clinic. Samples received prior to November 4, 2021, will be resulted from the temporary reference laboratory, Quest Diagnostics.

Refer to the details provided below for further information.

Testosterone, Total and Free, Serum (TFTEST) – Temporary Changes

Effective October 25, 2021.

Original Communication:

Beginning October 25, 2021, Testosterone, Total and Free, Serum (TFTEST) will be temporarily sent to an alternate reference laboratory (Quest Diagnostics).

This will occur automatically for new TFTEST samples received by Cleveland Clinic Laboratories.

Methodology

Methodology
The assays performed by both reference laboratories employ the same method, but there will be two main changes to the results:

1. Units of reporting for free testosterone will change from ng/dL to pg/mL.

Conversion factors:

Testosterone, free (ng/dL) x 10 = Testosterone, free (pg/mL)
Testosterone, free (pg/mL) / 10 = Testosterone, free (ng/dL)

2. Reference intervals for both free and total testosterone will be different.

Mayo Medical Laboratories: complete reference intervals
Quest Diagnostics: refer to the table below

Quest Diagnostics: Reference Intervals for Testosterone, Total (ng/dL)

Age

0-1 day

1-10 days

11-30 days

31 days – 2 months

3-4 months

5-6 months

7-11 months

12 months – 5 years

6-7 years

8-10 years

11 years

12-13 years

14-17 years

> 17 years

Male

17-61

<188

Not given

72-344

<202

<60

<17

<26

<43

<261

<421

<1001

250-1100

Female

16-44

<25

Not given

<18

<13

<14

<12

<21

<36

<41

2-45

Quest Diagnostics: Reference Intervals for Testosterone, Free (pg/mL)

Age

0-4 years

5-9 years

10-13 years

14-17 years

18-69 years

70-89 years

>89 years

Male

Not given

<5.4

0.7-52.0

18.0-111.0

35.0-155.0

30.0-135.0

Not given

Female

Not given

0.2-5.0

0.1-7.4

0.5-3.9

0.1-6.4

0.2-3.7

Not given

Specimen Requirements

Specimen Type
Serum

Collection Container
Red BD Hemogard™ Serum Tube (No Additive)

Volume
1.8 mL

Minimum Volume
0.9 mL

Do not draw serum gel tubes for this test.

Turnaround Time

Turnaround Time
Turnaround time for samples sent to the temporary performing laboratory (Quest Diagnostics) is estimated at 10 to 14 days.

TFTEST samples collected prior to October 25 will be resulted from the current reference laboratory (Mayo Medical Laboratories) but will have a delayed turnaround time of approximately 14 days.

September 2021: New Test – Beta(β)-D-Glucan Assay

Clinical Update

New Test: Beta(β)-D-Glucan Assay

In-house Beta(β)-D-Glucan (BDG) testing is now available.

The assay diagnoses certain systemic fungal infections, such as Candidemia, and assists in the prognostication and monitoring response to anti-fungal therapy in hospitalized patients.

This FDA-approved test is a protease zymogen-based colorimetric assay (FUNGITELL® ASSAY) based on a modification of the Limulus Amebocyte Lysate (LAL) pathway in which BDG, where present in the sample, binds Factor G. Activated Factor G turns a proclotting enzyme to clotting enzyme. The latter cleaves an artificial chromogenic substrate (a short peptide) to generate a color. The reaction occurs at 37°C and is kinetically read by a spectrophotometer to generate a standard curve and sample readouts that are subsequently converted to BDG concentrations in pg/ml.

It is important to note that certain fungi, such as the genus Cryptococcus that produces very low levels of BDG, may not result in serum BDG levels sufficiently elevated to be detected by the assay. Infections with fungi of the order Mucorales, such as Absidia, Mucor, and Rhizopus, that are not known to produce BDG can also yield non-detectable serum BDG levels. In addition, the yeast phase of Blastomyces dermatitidis produces little BDG and may not be detected by the assay. Furthermore, positive BDG results have been seen in hemodialysis patients, those who received certain fractionated blood products (such as albumin, IVIg), and those exposed to glucan-containing gauze or surgical sponges.

The sample should be centrifuged within 2 hours of collection to separate the serum from the cells.

Separated samples or serum should be stored refrigerated pending delivery to the testing laboratory.

Heel and fingerprick collections are unacceptable.

Test Name
(1,3) B-D Glucan

Test Code
BDGLUC

CPT Code
87449

Methodology
Protease zymogen-based colorimetric assay (FUNGITELL® ASSAY)

Specimen Requirements
Type: Serum
Volume: 0.5 mL
Container: Gold BD Hemogard™ Serum Separation Tubes (SST)™
Transport Temperature: Refrigerated

Stability
Ambient: Unacceptable
Refrigerated: 7 days
Frozen: 1 year

Reference Range
Negative; <60 pg/mL

Reportable Range
31 to 500 pg/mL

Days Performed
Monday, Wednesday, Friday

September 2021: Ziad Peerwani, MD Appointed as Medical Director of Cleveland Clinic Laboratories

Clinical Update

Ziad Peerwani, MD Appointed as Medical Director of Cleveland Clinic Laboratories

Ziad Peerwani, MD has been appointed as the new Medical Director for Cleveland Clinic Laboratories, effective September 1, 2021.

Dr. Peerwani was most recently CEO of Union71, based in Abu Dhabi, where he oversaw 17 laboratories, outpatient phlebotomy services, and the performance of more than 15 million lab tests per year.

“We look forward to the experience Dr. Peerwani brings to leading and growing our outreach laboratory services,” says Brian Rubin, MD, PhD, Chair of Cleveland Clinic’s Robert J. Tomsich Pathology & Laboratory Medicine Institute.

Ziad Peerwani, MD

About Dr. Peerwani:

In August 2020, Dr. Peerwani was appointed to carve out all laboratory services from SEHA, the government-owned health care system in Abu Dhabi, into an independent company while minimizing the impact on patient care and operations.

After successfully establishing the new business—Union71—Dr. Peerwani was appointed as its first CEO on October 4, 2020. During Union71’s first year, Dr. Peerwani stabilized and grew the laboratory while substantially outperforming Year 1 projections. Eventually, in March 2021, Union71 merged into PureHealth, with Dr. Peerwani supporting another transition.

Before serving as Union71’s CEO, Dr. Peerwani was Chairman of Pathology & Laboratory Medicine at Tawam Hospital, the regional cancer center for SEHA. He was also the section chief of hematopathology and flow cytometry, providing the majority of clinical sign-out over the years.

Prior to joining Tawam in 2014, Dr. Peerwani practiced general anatomic and clinical pathology at Baylor Scott & White All Saints Medical Center — Fort Worth.

Dr. Peerwani completed his residency and fellowship in Anatomic Pathology, Clinical Pathology, and Hematopathology at Cleveland Clinic.

Pathology Insights – Mammary Myofibroblastoma: A Practical Approach with Miglena Komforti, DO

Pathology Insights Video Series

Mammary Myofibroblastoma: A Practical Approach to Pathologic Diagnosis on Core Needle Biopsy

Presented by Miglena Komforti, DO

Myofibroblastoma is an uncommon benign neoplasm of the breast.

Dr. Miglena Komforti, a staff member of Cleveland Clinic’s Breast Pathology Section, discusses the histopathologic findings, ancillary immunohistochemical stains, molecular alterations, and clinical significance of mammary myofibroblastoma.

**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 2021: Changes to Specimen Requirements, Reference Ranges, and Test Builds

Special Communication

August 2021: Changes to Specimen Requirements, Reference Ranges, and Test Builds

All changes effective August 16, 2021.

Changes to Specimen Requirements

GALIGE

Allergen, Food, Alpha-Gal IgE (GALIGE)

Specimen Requirements

Specimen Type:
Serum

Volume:
0.25 mL

Minimum Volume:
0.25 mL

Collection Container:
Gold Serum Separation Tube (SST)

Transport Temperature:
Refrigerated

Additional Information:
Separate serum from cells ASAP or within 2 hours of collection.

MACPRO

Macroprolactin (MACPRO)

Specimen Requirements

Specimen Type:
Serum

Volume:
1 mL

Minimum Volume:
0.5 mL

Collection Container:
Gold Serum Separation Tube (SST)

Transport Temperature:
Frozen

Additional Information:
Allow specimen to clot completely at room temperature. Separate serum from cells and transfer into a standard aliquot tube.

Alternative Specimen Requirements

Specimen Type:
Plasma

Volume:
1 mL

Minimum Volume:
0.5 mL

Collection Container:
Lavender K₂EDTA Tube or Light Green Lithium Heparin Plasma Separator Tube (PST)

Transport Temperature:
Frozen

Additional Information:
Separate plasma from cells and transfer into a standard aliquot tube.

PROLM

Prolactin, Dilution Study (PROLM)

Specimen Requirements

Specimen Type:
Serum

Volume:
1 mL

Minimum Volume:
1 mL

Collection Container:
Gold Serum Separation Tube (SST)

Transport Temperature:
Frozen

Additional Information:
Allow specimen to clot completely at room temperature. Separate serum from cells and transfer into a standard aliquot tube.

Alternative Specimen Requirements

Specimen Type:
Plasma

Volume:
1 mL

Minimum Volume:
1 mL

Collection Container:
Lavender K₂EDTA Tube or Light Green Lithium Heparin Plasma Separator Tube (PST)

Transport Temperature:
Frozen

Additional Information:
Separate plasma from cells and transfer into a standard aliquot tube.

Changes to Reference Ranges

GALIGE

Allergen, Food, Alpha-Gal IgE (GALIGE)

Less than 0.10:
No significant level detected (Class Score 0)

0.10-0.34:
Clinical relevance undetermined (Class Score 0/1)

0.35-0.70:
Low (Class Score 1)

0.71-3.50:
Moderate (Class Score 2)

3.51-17.50:
High (Class Score 3)

17.51-50.00:
Very high (Class Score 4)

50.01-100.00:
Very high (Class Score 5)

Greater than 100.00:
Very high (Class Score 6)

IBDSER

IBD Serology Disease Panel (IBDSER)

Saccharomyces cerevisiae Antibody, IgA

20.0 Units or less:
Negative

20.1-24.9 Units:
Equivocal

25.0 Units or greater:
Positive

Saccharomyces cerevisiae Antibody, IgG

20.0 Units or less:
Negative

20.1-24.9 Units:
Equivocal

25.0 Units or greater:
Positive

ANCA IFA Titer

Less than 1:20

ANCA IFA Pattern

None detected

MACPRO

Macroprolactin (MACPRO)

Prolactin

Male
2.1-17.7 ng/mL

Female, 1-9 years
2.1-17.7 ng/mL

Female, 10 years and older
2.8-29.2 ng/mL

Monomeric, Prolactin

Male
2.1-13.3 ng/mL

Female, 1-9 years
2.1-13.3 ng/mL

Female, 10 years and older
2.8-19.5 ng/mL

Percent
Greater than 50%

OXLATE

Oxalate (OXLATE)

Normal
< or = 2.0 umol/L

PROLM

Prolactin, Dilution Study (PROLM)

Prolactin

Male
2.1-17.7 ng/mL

Nonpregnant Female, 1-9 years
2.1-17.7 ng/mL

Nonpregnant Female, 10 years and older
2.8-29.2 ng/mL

UNICOT

Nicotine & Metabolites, Urine (UNICOT)

Nicotine
15 ng/mL

Cotinine (metabolite)
15 ng/mL

3-OH-Cotinine (metabolite)
50 ng/mL

Anabasine (tobacco biomarker)
5 ng/mL

Changes to Test Build

GALIGE

Allergen, Food, Alpha-Gal IgE (GALIGE)

Components Affected

Allergen, Food, Alpha-Gal IgE

Reflex: Allergen Interp, Immunocap Score IgE

IBDSER

IBD Serology Disease Panel (IBDSER)

Components Affected

S. cerevisiae Antibody, IgA

S. cerevisiae Antibody, IgG

Inflammatory Bowel Disease Interp

ANCA IFA Titer

ANCA IFA Pattern

EER Inflammatory Bowel Diseases

MACPRO

Nicotine & Metabolites, Urine (UNICOT)

Components Affected

Remove Nornicotine, Urine

Test Discontinuations

HIV-1 Genotype (HIVGEN)

Reason for Discontinuation:
No longer offered by the vendor

Alternative Test:
HIV 1 Drug Resistance by Next Generation Sequencing (HIVNGS)

Anti-Neut Cyto Ab with Reflex to Titer and MPO/PR3 Ab (NCYTO)

Reason for Discontinuation:
No longer offered by the vendor

Alternative Test:
Neutrophil Cytoplasmic Antibody (ANCA)

Any additional information will be included in a future Technical Update. If you have any questions about these changes, please contact Client Services for assistance.