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Dear Providers,

East Side Clinical Laboratory is taking further steps to prevent the spread of COVID-19. Minimizing the risk of transmission among staff and between staff and patients as well as protecting people who are at higher risk for adverse health complications is of utmost concern to us.

In light of these concerns, we have implemented the following change to our practice to mitigate the impact of COVID -19:

We will not be providing nasal/throat swab collections (e.g. for influenza, group A strep, throat culture testing) at our Patient Service Centers or Independent Physician Offices during the ongoing COVID19 pandemic.

Note: Patients visiting a patient service center must wear a mask or face covering and must not be experiencing COVID -19 symptoms. Patients may not take their mask or face covering off while in our Patient Service Centers. We do not offer swab collection for COVID-19 testing.

Our mission is to provide the highest quality laboratory testing to our patients and clinical providers to aid in the diagnosis and treatment of disease.

For the safety of our patients and our staff, we cannot perform any specimen collections that would require patients to remove their masks or face coverings.

Thank you,

Walther M. Pfeifer, MD, FCAP Laboratory Director East Side Clinical Laboratory

Austin, TX – September 2, 2020

Today, Sonic Healthcare USA (Sonic) was awarded a contract from the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics Advanced Technology Platforms (RADx-ATP) initiative. The contract involves funding to expeditiously ramp up COVID-19 testing to 166,000 tests per day at nine of Sonic’s network of high-throughput laboratory testing locations, giving Sonic the capacity to service geographies across the United States.

Sonic was also selected by the U.S. Department of Health and Human Services (HHS) as one of two commercial laboratories to receive critical laboratory equipment to support the expansion of COVID-19 testing. Through these investments, aggressive expansion has begun at the following Sonic COVID-19 testing locations: American Esoteric Laboratories (AEL), located in Memphis, TN, Clinical Pathology Laboratories (CPL), located in Austin, TX and WestPac Labs located in Santa Fe Springs, CA. The added capacities will be coming online beginning this week.

While the NIH contract amplifies Sonic’s existing COVID-19 testing effort for all populations, a significant component includes improving testing access for underserved communities. Sonic has been supporting these populations directly and in partnership with local government and public health agencies. Funding from the RADx initiative will be used to develop comprehensive access with measurable coverage assessment for these populations. The RADx initiative complements Sonic’s current commitment to prioritize services to the most vulnerable and high-risk patients. Servicing these populations will continue to be a central part of our testing strategy.

“In response to the urgent pandemic demands, the partnership with the NIH and HHS, provides us access to technologies, instrumentation and resources necessary to rapidly increase the scope and expedite the timeline of our current capacity expansion plans,” said Dr. Jerry Hussong, MD, MBA, the Chief Executive Officer of Sonic HealthcareUSA. “The new testing capacity will increase patient access to COVID-19 diagnostic testing across the country with timely result delivery,” added Dr. Hussong.

This project is supported by the NIH Rapid Acceleration of Diagnostics (RADx) program and has been funded in whole or in part with federal funds from the National Institutes of Health Office of the Director, Department of Health and Human Services, under Contract No. 75N92020C00027.

Lyme Modified Two-Tier Test (MTTT)

Effective Monday, August 17, 2020, East Side Clinical Laboratory will offer testing for Lyme disease with the Modified Two-Tier Testing (MTTT) methodology. It is intended to be used in symptomatic patients suspected of having Lyme disease.

MTTT is a FDA cleared sensitive and specific alternative to Standard Two-Tier Testing (STTT) for Lyme disease. Unlike the STTT, the MTTT utilizes ELISA in both the first and second tiers, and does not utilize immunoblotting (Western Blot or Line Blot methods), detecting more acute Lyme disease cases compared with the traditional testing methods.

The first-tier is an ELISA which screens for B.burgdorferi VlsE/pepC10 IgG/IgM antibodies, with positives reflexing to the second tier.

The second-tier is an ELISA utilizing B.burgdorferi WCS (Whole Cell Sonicate antigens), comprised of specific assays for IgG and IgM, in which all results are individually reported with an Index Value, followed by comments and interpretations.

References:  

• Updated CDC recommendation for Serologic Diagnosis of Lyme Disease can be found in MMWR/August 16,2019/Vol. 68/No.32 703 or at
• https:www.cdc.gov/mmwr/volumes/68/wr/mm6832a4.htm?s_cid=6832a4_w

Test Code: 25851

Specimen Requirements: Serum from SST or plain red top tube

Transport Temperature: Refrigerated

Stability: 10 days refrigerated

CPT codes: 88618-If reflexed, add 86617(x2)

Please contact your ESCL account representative with any questions.

Effective July 1, 2020, East Side Clinical Laboratory has discontinued performing Acetest testing for serum and urine ketones due to discontinuation of reagent by the manufacturer and has been replaced with quantitative serum B-Hydroxybutyrate (6942).

The presence and degree of ketosis can be determined by measuring levels of Beta-hydroxybutyrate, which is the ketoacid present in the greatest amount in serum, accounting for 75% of the ketone bodies. During periods of ketosis, the relative percentage of Beta-hydroxybutyrate increases even more over the other two ketoacids (acetoacetate and acetone) and has been shown to be a better index of ketoacidosis including the detection of sub-clinical ketosis.

βHB levels have also been shown to be useful for assessing patients that may require additional insulin therapy following IV insulin drips for DKA. βHB may be helpful for establishing endpoints for IV therapy.

Discontinued tests with order codes:

Replacement test with order codes:

If you have any questions, please call East Side Clinical Laboratory at 800-455-8440

Or contact your East Side Clinical Laboratory representative.

Thank you for allowing us to continue to provide the highest quality laboratory testing services to you and your patients.

Effective April 30, 2020, East Side Clinical Laboratory (ESCL) will update reference ranges for the Complete Blood Count (CBC).

The new adult reference ranges reflect a Sonic Healthcare USA consensus which align with those of other large reference laboratories and hospital systems. The pediatric reference ranges align with those published by the American Association for Clinical Chemistry [Pediatric Reference Intervals, 7^th ed. (2011)] and American Society for Clinical Pathology [Practical Diagnosis of Hematologic Disorders, 4^th ed. (2006)].  The new reference ranges are not expected to significantly shift the percentage of patients flagged as having abnormal results; however, a shift of up to 5% in the number of patients with abnormal results for selected components such as hemoglobin may be seen.

Over the next 3 months, ESCL will make additional changes to CBC reporting that are aligned with accepted laboratory standards.  These include the following changes (implemented in the order listed):

• Reporting absolute WBC counts (absolute neutrophil count, absolute lymphocyte count, etc.) with respective reference ranges.

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

• Discontinuing reporting of reference ranges for relative (%) WBC differential counts as they are not the recommended method of reporting.

For questions related to CBC reference range changes, please contact your ESCL account representative.

March 16, 2020

East Side Clinical Laboratory, Inc. is pleased to announce that testing for SARS-Cov-2/COVID-19 is available as of March 10th, 2020.

Due to strong market demand and limited supply nationwide, priorities will be given to high risk patients in accordance to CDC guidelines and endemic regions and clusters.

Test Information:
Test Code: COVIDHR - 17100
Test Name: SARS-COV-2 (COVID-19) BY RT-PCR, HIGH RISK

Ordering Recommendations:
Ordering provider to determine patient risk level based on CDC Guidelines and clinical judgement.

• Sonic has created an orderable code to triage patients, prioritize testing and coordinate with public health authorities:
     o SARS-COV-2 (COVID-19) - High Risk: Patients who are symptomatic, exhibiting respiratory illness (cough, fever, and dyspnea) AND have traveled to a COVID-19 endemic area, have been in close contact with a known COVID-19 patient or are otherwise considered High Risk exposure from an epidemiological perspective.
• Criteria to Guide Evaluation of PUI (Persons Under Investigation) for COVID-19: The CDC currently states Clinicians should use their judgment to determine if a patient has signs and symptoms compatible with COVID-19 and whether the patient should be tested. Decisions on which patients receive testing should be based on the local epidemiology of COVID-19, as well as the clinical course of illness.
• Clinicians are strongly encouraged to test for other causes of respiratory illness, including infections such as influenza.

• In accordance with public health guidance, clinicians should prioritize testing to following groups:
  1. Hospitalized patients who have signs and symptoms compatible with COVID-19 in order to inform decisions related to infection control.
  2. Other symptomatic individuals, such as older adults and individuals with chronic medical conditions and/or an immunocompromised state that may put them at higher risk for poor outcomes (e.g., diabetes, heart disease, receiving immunosuppressive medications, chronic lung disease, chronic kidney disease).
  3. Any person, including healthcare personnel, who within 14 days of symptom onset had close contact with a suspected or laboratory-confirmed COVID-19 patient, or who had a history of travel from affected geographic areas.

Specimen Requirements:
Sample Type:
• Upper Respiratory Tract: Nasopharyngeal Swab
Container Type: *Prefer dedicated collection device
• Nasopharyngeal swab: Viral or Universal Transport Media (VTM, UTM, VCM, UTM-RT, or M4) with Swab(s).

Must be ordered independent of other testing and include CDC PUI Form.

Handling Instructions:
Nasopharyngeal Swab: Insert a swab into the nostril parallel to the palate. Leave the swab in place for a few seconds to absorb secretions. Place swab immediately into sterile tube containing 2- 3 mL of viral transport media.
Transport: Critical Refrigerated
Unsuitable Specimens: Ambient specimens. Swabs not in viral transport media. Calcium alginate swabs. Swabs with wooden shafts. eSwab, any device refrigerated more than 72 hours post collection.

Testing Capacity:
Testing is performed seven days a week.
• Expected TAT is 1-3 days.
   o TAT may vary with changes in capacity and market demands.

CPT Codes: U0001 – Real-Time Polymerase Chain Reaction (RT-PCR)
LOINC Codes: SARS-CoV-2 Interpretation (94306-8), Naso and Oro SARS-CoV-2 (94316-7), Nasopharyngeal SARS-CoV-2 (94316-7)

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Austin, Texas – March 13th, 2020

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

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

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

About Sonic Healthcare USA

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

Austin, Texas – March 6th, 2020

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

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

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

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

Read the ACLA Statement on COVID-19 Testing

About Sonic Healthcare USA

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

Issued December 10, 2019: The previous protocol for urine cultures being processed by East Side Clinical Laboratory was to re-incubate for an additional 24 hours if no growth was observed initially on day 1.  Current understanding of urinary pathogens has now rendered this re-incubation unnecessary.  Most causative agents of UTI’s can be identified by routine urine culture, which has been published as not benefitting from 48 hours of incubation.  East Side Clinical Laboratory will continue to re-incubate cultures from catheterized specimens, children 10 years of age or younger, or if a clinician suspects a fastidious pathogen that requires additional incubation.

Our goal at East Side Clinical Laboratory is to ensure that patients receive results in a timely manner without compromising testing.  By reporting urine cultures in 24 hours, we ensure results are communicated timely to guide treatment decisions.  Additional incubation on routine urine cultures will not be performed unless specifically requested.

For more information regarding the change in protocol, please contact your ESCL representative or the ESCL Microbiology Supervisor (Kelly Messier, 401-455-8427). 

Thank you for allowing us to continue to provide the highest quality laboratory testing services to you and your patients.

REFERENCES:

• Wilson ML, Gaido L.  Laboratory Diagnosis of Urinary Tract Infections in Adult Patients. Clinical Infectious Diseases. 15 Apr 2004,38(8):1150-1158. DOI 10.1086/383029.
• Shoskes D. The American Urological Association Educational Review Manual in Urology. Third Edition. Chapter 23: Urinary Tract Infections. 2011.
• Ulett KB, Benjamin Jr WH, Zhuo F, et al. Diversity of Group B Streptococcus Serotypes Causing Urinary Tract Infection in Adults. ASM Journal of Clinical Microbiology. July 2009,47(7):2055-2060. DOI 10.1128/JCM.00154-09

• Patients on high dose supplements of biotin (minimum 5-10 mg/day), such as hair/nail/ skin supplements, should refrain from taking them in the 24 hours prior to laboratory test.
• Supplements may or may not prominently indicate they contain biotin.
• Patients taking prescribed megadose regimens (>150 mg biotin, usually prescribed for multiple sclerosis) should refrain from taking the supplements for 2-3 days prior to laboratory testing, after consulting with their physician.

THE LEVEL OF BIOTIN TYPICALLY FOUND IN MULTIVITAMIN TABLETS DOES NOT INTERFERE WITH LABORATORY TESTING. *Patients and physicians should review any lab test result that does not match the clinical presentation and consider if biotin interference is present.

Effective November 4, 2019, East Side Clinical Laboratory will no longer offer Helicobacter pylori (H. pylori) serology testing based upon changes in H. pylori testing guidelines of the American College of Gastroenterology and the American Gastroenterology Association. The discontinued antibody tests below will be inactivated in our compendium and will not be orderable. Serological antibody results have poor positive predictive value (PPV) and are no longer considered clinically useful. The alternative noninvasive testing methods demonstrate higher clinical utility, sensitivity, and specificity.

A positive H. pylori IgG, IgA, or IgM result cannot be used to predict the presence of active disease. Since antibodies to H. pylori remain detectable for years following resolution of infection, serologic testing cannot be used to distinguish active from past infection or to document eradication of the organism following successful treatment.

Many insurance companies are no longer reimbursing patients for whom H. pylori serologic testing was performed, as they consider such testing “not medically necessary”. As an alternative, providers are encouraged to collect samples for Urea Breath Test or Stool Antigen Test. Both assays are FDA cleared for use to detect H. pylori infection, and as a test of eradication. Clients should order collection kits as needed with instructions for use.

Discontinued Test With Order Codes:

Recommended Tests With Order Codes

If you have any questions please call East Side Clinical Laboratory at 800.455.8440 or contact your East Side Clinical Laboratory representative.

Effective September 15, 2019 East Side Clinical Laboratories will offer a new collection device, the APTIMA Multitest Orange Swab for Bacterial Vaginosis, Candida, Gonorrhea (GC), Chlamydia (CT) and Trichomonas (Trich) Amplification Testing. This swab can be used in place of the white label APTIMA swab (with the exception of endocervical and male urethral samples).

APTIMA Multitest Orange Swab Utilization

Specimen Information

Effective January 1, 2019, East Side Clinical Laboratory (ESCL) will discontinue offering combined testing for high and low risk Human Papillomavirus (HPV). Low Risk HPV will no longer be performed. This change is due to the implementation of newer analytic methods and testing algorithms.

The following tests/order codes will be deleted with this update:

HPV low risk will be removed from the following test codes with this update:

As an alternative, ESCL offers Roche high risk HPV testing with genotyping information. Amongst high risk HPV infections, genotypes 16 and 18 are most strongly associated with cervical cancer and severe Dysplasia/CIN3.

For high risk testing with genotype information, we offer the following:

High risk HPV:

• Co-testing is endorsed by the American Congress of Obstetricians and Gynecologists (ACOG) and other authorities for woman 30-65 years of age

   

• Algorithms adopted by the American Society for Colposcopy and Cervical Pathology (ASCCP) recommend high risk HPV genotyping for types 16 or 18 as an immediate alternative to a return visit for a  pelvic examination and repeat co-testing for those patients found to be high risk HPV positive and PAP negative(see algorithms at www.asccp.org/Guidelines)
• Genotyping for 16 and 18 can be used to refine management of women 21-29 years of age in certain clinical scenarios

For questions related to HPV testing options, please contact your ESCL account representative.

East Side Clinical Laboratory is pleased to announce the introduction of the QuantiFERON-TB Gold Plus assay which offers optimized analysis with tuberculosis (TB)-specific antigens that elicit both CD4+ and CD8+ T-cell responses. The new 4-tube collection set enables a more comprehensive assessment of cell-mediated immune responses to TB infection

Clients should begin to order QFT - 4 tube kits but may continue to send the 3-tube collection kits until January 1, 2019 when the 3-tube version will be discontinued.

The 4-tube assay requires the same pre-analytical processing steps as the current 3 tube QuantiFERON Gold assay. Immediately after filling the tubes with 1ml blood, shake 10 times just firmly enough to coat the inner surface of the tubes without disrupting the gel.

Please use test code 9884 when ordering the 4-tube assay. Tubes should remain at room temperature for same day transport to ESCL

For questions related to TB GOLD Plus testing, please contact your ESCL account representative.

Thank you for choosing East Side Clinical Laboratory