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Client Communication

2022

Test Name:

Candida Vaginitis (CV), TMA

Order Code:

U114

Specimen Requirements:

One vaginal swab collected in Aptima Multitest Collection Kit (orange label)

Transport Temperature:

Room Temperature

Result Fields:

U1140 - CANDIDA SPECIES
U1141 - CANDIDA GLABRATA

Methodology:

Transcription-Mediated Amplification (TMA)

Reference Range:

Not detected

CPT Code:

87481 x 2

Additional Notes:

Collection Instructions: Follow instructions provided in the Aptima Multitest Collection Kit (orange label).

Rejection Criteria: Non-Aptima collection kit. Leaking samples. Uncapped specimens. Broken containers. Transport tube with no swab. Transport tube with 2 swabs. Transport tube containing cleaning swabs. Transport tube submitted with swab inverted. Expired Aptima tubes.

Stability: 30 Days Room Temperature; 30 Days Refrigerated; 60 Days Frozen

Days Performed/
Turn Around Time:

Daily/1-3 Days

Testing Location:

Sunrise Medical Laboratories
250 Miller Pl., Hicksville, NY 11801
CLIA No.: 33D0654120

Test Name:

Bacterial Vaginosis (BV), TMA

Order Code:

U113

Specimen Requirements:

One vaginal swab collected in Aptima Multitest Collection Kit (orange label)

Transport Temperature:

Room Temperature

Result Fields:

U1130 - BACTERIAL VAGINOSIS (BV), TMA

Methodology:

Transcription-Mediated Amplification (TMA)

Reference Range:

Not detected

CPT Code:

81513

Additional Notes:

Collection Instructions: Follow instructions provided in the Aptima Multitest Collection Kit (orange label).

Rejection Criteria: Non-Aptima collection kit. Leaking samples. Uncapped specimens. Broken containers. Transport tube with no swab. Transport tube with 2 swabs. Transport tube containing cleaning swabs. Transport tube submitted with swab inverted. Expired Aptima tubes.

Stability: 30 Days Room Temperature; 30 Days Refrigerated; 60 Days Frozen

Days Performed/
Turn Around Time:

Daily/1-3 Days

Testing Location:

Sunrise Medical Laboratories
250 Miller Pl., Hicksville, NY 11801
CLIA No.: 33D0654120

Test Name:

Vaginitis Total, TMA

Order Code:

U115

Specimen Requirements:

One vaginal swab collected in Aptima Multitest Collection Kit (orange label)

Transport Temperature:

Room Temperature

Result Fields:

U1130 - BACTERIAL VAGINOSIS (BV), TMA
U1140 - CANDIDA SPECIES
U1141 - CANDIDA GLABRATA
U1150 - T. VAGINALIS (TV), TMA

Methodology:

Transcription-Mediated Amplification (TMA)

Reference Range:

Not detected

CPT Code:

81513, 87481 x 2, 87661

Additional Notes:

Collection Instructions: Follow instructions provided in the Aptima Multitest Collection Kit (orange label).

Rejection Criteria: Non-Aptima collection kit. Leaking samples. Uncapped specimens. Broken containers. Transport tube with no swab. Transport tube with 2 swabs. Transport tube containing cleaning swabs. Transport tube submitted with swab inverted. Expired Aptima tubes.

Stability: 30 Days Room Temperature; 30 Days Refrigerated; 60 Days Frozen

Days Performed/
Turn Around Time:

Daily/1-3 Days

Testing Location:

Sunrise Medical Laboratories
250 Miller Pl., Hicksville, NY 11801
CLIA No.: 33D0654120

Test Name:

Vaginitis Plus STI, TMA

Order Code:

U116

Specimen Requirements:

One vaginal swab collected in Aptima Multitest Collection Kit (orange label)

Transport Temperature:

Room Temperature

Result Fields:

U1130 - BACTERIAL VAGINOSIS (BV), TMA
U1140 - CANDIDA SPECIES
U1141 - CANDIDA GLABRATA
U1150 - T. VAGINALIS (TV), TMA
U1160 - C. TRACHOMATIS, UROGEN
U1161 - N. GONORRHOEAE, UROGEN

Methodology:

Transcription-Mediated Amplification (TMA)

Reference Range:

Not detected

CPT Code:

81513, 87481 x 2, 87661, 87491, 87591

Additional Notes:

Collection Instructions: Follow instructions provided in the Aptima Multitest Collection Kit (orange label).

Rejection Criteria: Non-Aptima collection kit. Leaking samples. Uncapped specimens. Broken containers. Transport tube with no swab. Transport tube with 2 swabs. Transport tube containing cleaning swabs. Transport tube submitted with swab inverted. Expired Aptima tubes.

Stability: 30 Days Room Temperature; 30 Days Refrigerated; 60 Days Frozen

Days Performed/
Turn Around Time:

Daily/1-3 Days

Testing Location:

Sunrise Medical Laboratories
250 Miller Pl., Hicksville, NY 11801
CLIA No.: 33D0654120

Test Name:

HSV 1 and 2 MRNA, TMA

Order Code:

U117

Specimen Requirements:

One male or female anogenital lesion swab collected in Aptima Multitest Collection Kit (orange label)

Transport Temperature:

Room Temperature

Result Fields:

U1170 - HSV-1 RNA, TMA

U1171 - HSV-2 RNA, TMA

Methodology:

Transcription-Mediated Amplification (TMA)

Reference Range:

Not detected

CPT Code:

87529 x 2

Additional Notes:

Collection Instructions: Follow instructions provided in the Aptima Multitest Collection Kit (orange label). Remove the swab from the packaging and swab any visible lesions. Withdraw the swab without touching the skin. Immediately place the swab into the transport tube so that the tip of the swab is visible below the tube label. Carefully break the swab shaft at the score line against the side of the tube and discard the top portion of the swab shaft. Tightly screw the cap onto the tube.

Rejection Criteria: Non-Aptima collection kit. Leaking samples. Uncapped specimens. Broken containers. Transport tube with no swab. Transport tube with 2 swabs. Transport tube containing cleaning swabs. Transport tube submitted with swab inverted. Expired Aptima tubes.

Stability: 30 Days Room Temperature; 30 Days Refrigerated; 60 Days Frozen

Days Performed/
Turn Around Time:

Daily/1-3 Days

Testing Location:

Sunrise Medical Laboratories
250 Miller Pl., Hicksville, NY 11801
CLIA No.: 33D0654120

Effective 12/05/2022, this test offering will be discontinued. Refer to new test U117 HSV 1 and 2 MRNA, TMA.

Effective 12/05/2022, this test offering will be discontinued. Refer to alternate test U104 Trichomonas Vaginalis, Amplified.

Effective December 18, 2022, Sunrise Medical Laboratories will discontinue accepting EDTA Lavender-top tubes for venous blood lead testing. We ask that you only submit lead-free Tan top tubes or trace element-free Royal Blue top EDTA tubes for venous blood lead testing. Until such time, specimens received in non-metal free EDTA vials are viable, however if results are elevated a qualifier will be added to the report due to the potential for spurious contamination from the non-metal free vial. Capillary specimens used in pediatric populations can continue to be collected in the lavender microtainer tubes for blood lead screening purposes.

Sunrise Medical Laboratories is pleased to provide outstanding patient care by minimizing the risk of falsely elevated results and frequent redraws that can occur when samples for trace elements testing are not collected in certified metals-free collection tubes.

Test update pertains to the following Sunrise Medical Laboratories test offerings:

  • LEAD,BLOOD (VENOUS)
  • LEAD,CAPILLARY
  • LEAD, INDUSTRIAL EXPOSURE PANEL

Please contact Sunrise Medical Laboratories for supply requests and any further information at 800.782.0282

Please be advised for the referral test offerings listed below, major shipping providers such as FedEx, UPS, and other local couriers that Sunrise utilizes will not pick up or deliver specimens on Thursday, November 24, 2022, in observance of Thanksgiving Day. Referral test pick-up and delivery will resume on Friday November 25, 2022. This does not apply to the Sunrise Medical Lab Couriers who will be available for routine specimen pick-ups.

Please take note of the following special instructions to ensure specimen integrity.

It is highly recommended that you not draw specimens for the reference tests listed below from Tuesday, November 22rd through Thursday, November 24th. These specimens will not maintain their integrity through the Thanksgiving Day holiday:

  • T, B and NK Lymphocyte Enumeration Panel
  • Lymphocyte Subset Panel Testing (CD3, CD4, CD8)
  • HNK1 (CD57)
  • BCR/ABL1 Mutation
  • Neutrophil Oxidative Burst
  • JAK2 Gene V617F Mutation, JAK2 with Reflex to Exon12, MPL, CALR
  • Respiratory Viral Culture
  • HLA-B27 Antigen
  • Folate RBC
  • AFB Culture; Mycobacterium/AFB Stain
  • HSV Culture with Reflex to Typing

Sunrise Medical Laboratories thanks you for allowing us to continue to provide the highest quality laboratory testing to you and your patients. We wish you a safe, healthy and happy holiday.

For questions, contact Sunrise Medical Laboratories Customer Service Department at 800.782.0282.

Updates are in yellow:

Test Name:

Nicotine And Metabolites, Serum or Plasma

Order Code:

L624

Specimen Requirements:

Plain red, green (sodium heparin) or lavender (EDTA). Separate serum or plasma from cells ASAP or within 2 hours of collection. Transfer 4 mL serum or plasma to a standard transport tube. (Min: 1 mL)

Transport Temperature:

Refrigerated

CPT Code:

80323 (Alt Code G0480)

Rejection Criteria: 

Plasma or whole blood collected in lt. blue (sodium citrate) or SST. Specimens exposed to repeated freeze/thaw cycles. Hemolyzed specimens.

Stability:

After separation from cells: 1 Week Ambient; 2 Weeks Refrigerated; 3 Years Frozen

Days Performed/
Turn Around Time:

Daily/2-5 Days

Testing Location:

ARUP Laboratories
500 Chipeta Way, Salt Lake City, UT 84108-1221

 

Please be advised for the referral test offerings listed below, major shipping providers such as FedEx, UPS, and other local couriers that Sunrise utilizes will not pick up or deliver specimens on Monday, September 5, 2022, in observance of Labor Day. Referral test delivery will resume on Tuesday September 6, 2022. This does not apply to the Sunrise Medical Lab Couriers as they will be available for routine specimen pick-ups.

Please take note of the following special instructions to ensure specimen integrity.

It is highly recommended not to draw specimens for the reference tests listed below from Friday, September 2nd through Monday, September 5th . These time sensitive specimens will not maintain their integrity through the Labor Day holiday:

  • T, B and NK Lymphocyte Enumeration Panel
  • Lymphocyte Subset Panel Testing (CD3, CD4, CD8)
  • HNK1 (CD57)
  • BCR/ABL1 Mutation
  • Neutrophil Oxidative Burst
  • JAK2 Gene V617F Mutation, JAK2 with Reflex to Exon12, MPL, CALR
  • Respiratory Viral Culture
  • HLA-B27 Antigen
  • Folate RBC
  • AFB Culture; Mycobacterium/AFB Stain
  • HSV Culture with Reflex to Typing

For questions, contact Sunrise Medical Laboratories Customer Service Department at 1-800-782-0282.

Changes in specimen requirements and CPT codes:

Test Name:

Natural Killer Cell and Natural Killer T-Cell Panel 

Order Code:

V116

Specimen Requirements:

Dedicated 4 mL whole blood collected in an EDTA (Lavender Top) Tube. Heparin (Green Top) Tube is no longer acceptable.

Transport Temperature:

Critical Room Temperature

CPT Code:

86356 x 3; 86357; 86359

Rejection Criteria: 

Refrigerated and frozen samples are unacceptable. Clotted or hemolyzed specimen.

Stability:

48 Hours Room Temperature

Days Performed/
Turn Around Time:

Daily / 2-4 Days

Testing Location:

ARUP Laboratories
500 Chipeta Way, Salt Lake City, UT 84108-1221

 

Effective July 25, 2022, Sunrise Medical Laboratories is pleased to announce the availability of Monkeypox Virus by PCR testing.

Monkeypox Virus PCR test methodology is real-time PCR utilizing the CDC Non-variola Orthopoxvirus Real-Time PCR Primer and Probe Set. The assay detects non-variola Orthopoxvirus DNA in clinical specimens. Although this assay does not differentiate monkeypox virus from other Orthopoxvirus including vaccinia, cowpox, camelpox, ectromelia or gerbilpox virus a positive result with this assay in the United States is most likely due to monkeypox virus; however, potential exposure to other Orthopoxviruses should be considered.

The test results are intended to be utilized in conjunction with clinical presentation, epidemiological data, other diagnostic test results, and vaccination and exposure history. As monkeypox virus infections can present with rashes/lesions similar to that of varicella zoster virus, herpes simplex virus, and other sexually transmitted infections, consider testing for other pathogens as clinically indicated.

Test Name: Monkeypox Virus by PCR
Order Code:

F970

Specimen Requirements:

Swabs from skin lesion

Preferred Container: Sterile leak-proof screw cap tube preferably with O-ring or gasket seal

Alternate Container: Swabs in viral transport medium (VTM) 

Sample Volume: Two swabs

Refer to collection instructions below.

Transport Temperature: Frozen
Results Fields:

F9700 - MONKEYPOX VIRUS, PCR (LOINC: 100434-0)

F9701 - Specimen Type (LOINC: 31208-2)

F9704 - Source Site (LOINC: 39111-0)

F9702 - Symptomatic (nr) (LOINC: 95419-8)

F9703 - Symptom Onset Date (nr) (LOINC: 11368-8)

Note: Source Site is a NEW reportable AOE (Ask-order-entry prompt); free-text. (Example response: Left Hand, Abdomen, Leg, etc)

Specimen is a reportable prompt (AOE). **Preferred responses are one of the following:

  • Biopsy
  • Scab Specimen (Crust)
  • Dry Lesion Swab
  • Nodule
  • Touch Prep
  • Vesicle Fluid
  • Wet Lesion Swab
  • Not Specified

Symptomatic and Symptom Onset Date are Optional non-reportable prompts.

Methodology: Real-Time Polymerase Chain Reaction (RT-PCR)
Reference Range: Not Detected
CPT Code: 87593
Collection Instructions:

Updated as of 08/24/2022

Collect two swabs from each lesion. Swab 2-3 lesions from different parts of the body or lesions with differing appearance. Do NOT collect and submit swabs from more than 3 lesions. Vigorously swab or brush active lesion with two separate sterile synthetic swabs (e.g. Dacron, polyester, or nylon) with a plastic shaft and breakpoint close to the tip. Do NOT use cotton swabs. Break off or cut the tip of each swab into a sterile tube or tube with 1 mL of VTM. Each swab should be placed in a separate tube. Parafilm may be used to ensure a leak-proof lid if the tube does not have an O-ring or gasket seal. The length of the swabs after breaking or cutting should be no longer than 35mm (1.5 in.). Do NOT add transport media to specimens intended to be shipped as dry swabs. Refrigerate or freeze specimen immediately after collection. Freezing is strongly recommended. To maintain optimum specimen viability, transport the specimen to the laboratory as soon as possible.

Rejection Criteria: 

Swabs from more than 3 lesions. Single swab. Cotton swabs. Swabs with wooden or metal shafts. Swabs in transport media other than VTM. Out of stability specimens. Ambient specimens.

Stability: 7 days Refrigerated; 1 month Frozen.
Frequency / Expected Turnaround Time: Monday – Friday / 2-3 days.
Turn-around time may vary with changes in capacity and market demands.
Testing Location: Sonic Reference Laboratories (SRL)
3800 Quick Hill Rd., Bldg 3, Ste 101, Austin, TX 78728
CLIA 45D2083658

 

Effective July 25, 2022, Sunrise Medical Laboratories is pleased to announce the availability of Monkeypox Virus by PCR testing.

Monkeypox Virus PCR test methodology is real-time PCR utilizing the CDC Non-variola Orthopoxvirus Real-Time PCR Primer and Probe Set. The assay detects non-variola Orthopoxvirus DNA in clinical specimens. Although this assay does not differentiate monkeypox virus from other Orthopoxvirus including vaccinia, cowpox, camelpox, ectromelia or gerbilpox virus a positive result with this assay in the United States is most likely due to monkeypox virus; however, potential exposure to other Orthopoxviruses should be considered.

The test results are intended to be utilized in conjunction with clinical presentation, epidemiological data, other diagnostic test results, and vaccination and exposure history. As monkeypox virus infections can present with rashes/lesions similar to that of varicella zoster virus, herpes simplex virus, and other sexually transmitted infections, consider testing for other pathogens as clinically indicated.

Test Name: Monkeypox Virus by PCR
Order Code: 20590
Specimen Requirements:

Swabs from skin lesion

Preferred Container: Sterile leak-proof screw cap tube preferably with O-ring or gasket seal

Alternate Container: Swabs in viral transport medium (VTM) 

Sample Volume: Two swabs

Refer to collection instructions below.

Transport Temperature: Frozen
Results Fields:

20590 - MONKEYPOX VIRUS, PCR (LOINC: 100434-0)

20594 - Source Site (LOINC: 39111-0)

20591 - Specimen (LOINC: 31209-2)

20592 - Symptomatic (nr) (LOINC: 95419-8)

20593 - Symptom Onset Date (nr) (LOINC: 11368-8)

Note: Source Site is a NEW reportable AOE (Ask-order-entry prompt); free-text.

Specimen is a reportable prompt (AOE).

**Preferred responses are one of the following:

  • Biopsy
  • Crust
  • Dry Lesion Swab
  • Nodule
  • Touch Prep
  • Vesicle Fluid
  • Wet Lesion Swab
  • Not Specified

Symptomatic and Symptom Onset Date are Optional non-reportable prompts.

Methodology: Real-Time Polymerase Chain Reaction (RT-PCR)
Reference Range: Not Detected
CPT Code: 87593
Collection Instructions:

Updated as of 08/24/2022

Collect two swabs from each lesion. Swab 2-3 lesions from different parts of the body or lesions with differing appearance. Do NOT collect and submit swabs from more than 3 lesions. Vigorously swab or brush active lesion with two separate sterile synthetic swabs (e.g. Dacron, polyester, or nylon) with a plastic shaft and breakpoint close to the tip. Do NOT use cotton swabs. Break off or cut the tip of each swab into a sterile tube or tube with 1 mL of VTM. Each swab should be placed in a separate tube. Parafilm may be used to ensure a leak-proof lid if the tube does not have an O-ring or gasket seal. The length of the swabs after breaking or cutting should be no longer than 35mm (1.5 in.). Do NOT add transport media to specimens intended to be shipped as dry swabs. Refrigerate or freeze specimen immediately after collection. Freezing is strongly recommended. To maintain optimum specimen viability, transport the specimen to the laboratory as soon as possible.

Rejection Criteria: 

Swabs from more than 3 lesions. Single swab. Cotton swabs. Swabs with wooden or metal shafts. Swabs in transport media other than VTM. Out of stability specimens. Ambient specimens.

Stability: 7 days Refrigerated; 1 month Frozen.
Frequency / Expected Turnaround Time: Monday – Friday / 2-3 days.
Turn-around time may vary with changes in capacity and market demands.
Testing Location: Sonic Reference Laboratories (SRL)
3800 Quick Hill Rd., Bldg 3, Ste 101, Austin, TX 78728
CLIA 45D2083658

 

2021

On November 30, 2021, the U.S. SARS-CoV-2 Interagency Group (SIG), which includes the Centers for Disease Control and Prevention (CDC), the National Institutes of Health, the Food and Drug Administration (FDA), and Health and Human Services (HHS), classified the Omicron variant as a Variant of Concern. The current understanding of the Omicron VOC at this time is as follows: 

  • Preliminary data from South Africa suggest that the mutations to the receptor binding protein of the variant virus will confer increased infectivity.
  • Preliminary studies indicate that there are no unusual symptoms associated with Omicron variant infection, and as with other variants, some patients are asymptomatic. Symptoms may be milder in persons who have been vaccinated or previously infected with SARS CoV-2.
  • The presence of mutations in the SARS-CoV-2 virus in a patient sample has the potential to impact test performance. The impact of mutations on a test's performance is influenced by several factors, including the sequence of the variant, prevalence of the variant in the population, and the design of the test including the analytic target. Indeed, tests which interrogate for a single target are particularly vulnerable.

Laboratory evaluation of SARS-CoV-2, including the Omicron Variant of Concern, at Sunrise Medical Laboratories:

  • All high-throughput SARS-CoV-2 molecular assays performed at Sunrise Medical Laboratories are designed to interrogate for multiple targets of the viral genome and have received emergency-use authorization by the FDA.
  • Based on in silico analysis, all molecular assays are expected to detect the Omicron variant of concern.
  • For some assays, including the Thermo Fisher Taq Path PCR assay, a specific deletion in the spike (S) gene (Δ69-70) in the Omicron variant results in an S-gene dropout, also referred to as an S-gene target failure (SGTF).
    • The S-gene target failure pattern may be identified in the Omicron variant (BA.1 sub-lineage), but this pattern is also seen in previously identified variants (e.g., Alpha).
    • Since these tests are designed to detect multiple genetic targets, the overall test sensitivity is not significantly impacted.
    • The S-gene target failure pattern provides a signal that the Omicron variant (BA.1) may be present and that the isolate may be suitable for sequencing and/ or other public health considerations.
    • The S-gene target failure pattern does not necessarily mean that an individual with SARS-CoV-2 has the Omicron variant.
  • For clients who have concerns about antigen or other point of care assays that they provide, the assay manufacturer can be contacted for information about expected analytical performance impact.
References: 
  • New SARS-CoV-2 Variant of Concern Identified: Omicron (B.1.1.529) Variant. Health Alert Network 00459. December 1, 2021.
  • SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests. U.S. Food and Drug Administration. December 6, 2021.
  • Technical Brief: Predicted Impact of Variants on Abbott SARS-CoV-2/COVID-19 Diagnostic Tests. Abbott. November 26, 2021
  • Impact of SARS-CoV-2 mutations (including Omicron) on the cobas® SARS-CoV-2 and cobas® SARS-CoV-2 & Influenza A/B Tests for use on the cobas® 6800/8800 Systems and the cobas® SARS-CoV-2 and cobas® SARS-CoV-2 & Influenza A/B Tests for use on the cobas® Liat® System. Roche Client Bulletin. November 30, 2021.
  • Thermo Fisher Scientific Confirms Detection of SARS-CoV-2 in Samples Containing the Omicron Variant with its TaqPath COVID-19 Tests. Thermo Fisher Client Bulletin. November 29, 2021.

Effective Monday, December  6, 2021, Sunrise Medical Laboratories will adopt the single CKD-EPI Refit equation to replace the separately reported eGFR – Black and eGFR – Non-Black calculations for all serum creatinine measures in response to recommendations from the National Kidney Foundation and American Society of Nephrology (NKF-ASN) Task Force on estimated glomerular filtration rate (eGFR). 

The Task Force was established in July 2020 to consider inequity in diagnosis, management and outcomes of Chronic Kidney Disease (CKD) in Black patients including recognition and management of kidney-disease risk factors, comorbidities, and progression to kidney failure.  Additionally, the deliberations were informed by the significantly higher prevalence of hypertension and decline in measured GFR at an earlier age and steeper slope for Black versus non-Blacks associated with lower rates of nephrology referral, dialysis options and transplantation. 
With input from more than 90 experts in the field and public members, the Task Force recommended: 

  1. Immediate implementation of the new 2021 CKD-EPIcr_R calculation for eGFR based on creatinine, to replace separately reported race-based eGFR’s. 
  2. National efforts to facilitate routine and timely use of cystatin C, to confirm eGFR in adults who are at risk for or have CKD. Cystatin C can be used alone or paired with simultaneous creatinine measure for the most accurate eGFR (eGFRcr-cys_R).

To facilitate transition and inform patients, NKF offers an eGFR Summary for Ordering Clinicians https://www.kidney.org/sites/default/files/02-10-8361_icb_egfr_summary_flyer.pdf

Additional References: 

  • Delgado C et al. A Unifying Approach for GFR Estimation: Recommendations of the NKF- ASN Task Force on Reassessing the Inclusion of Race in Diagnosing Kidney Disease. Am J Kidney Dis. 2021 Sep 22:S0272-6386(21)00828-3. 
  • Inker LA, Eneanya ND,Coresh J, et al. New creatinine- and cystatin C-based equations to estimate GFR without race. N Engl J Med. 2021 Sep 23.doi: 10.1056/NEJMoa2102953. Online ahead of print.

For questions, contact Sunrise Medical Laboratories Customer Service Department at 1-800-782-0282.  

Austin, TX – April 19, 2021

Sonic Healthcare USA (Sonic), a leading provider of laboratory services in the United States, was recently included as a laboratory testing partner for the Rockefeller Foundation’s K-12 National Testing Action Program (NTAP). The NTAP program introduces school districts in the United States to leading testing companies supporting COVID-19 testing for K-12 students.

Over the last year, Sonic has been one of the leading commercial laboratories performing COVID-19 testing throughout its network of clinical laboratories and pathology practices in the United States. Sonic continues to focus on and support specific underserved patient populations and government-funded programs in partnership with local government and public health agencies to improve testing access for these communities.

Sonic is expanding testing capacity for K-12 testing programs at the following laboratory locations: American Esoteric Laboratories, located in Memphis, TN; Bernhardt Laboratories, located in Jacksonville, FL; Clinical Labs of Hawaii, located in Honolulu, HI; Clinical Pathology Laboratories, located in Austin, TX; East Side Clinical Laboratory, located in Providence, RI; GPA Laboratories, located in Greensboro, NC; LMC Pathology Services, located in Las Vegas, NV; Seacoast Pathology, located in Exeter, NH; Sunrise Medical Laboratories, located in Hicksville, NY; and WestPac Labs, located in Santa Fe Springs, CA.

“We are honored and privileged to be included amongst the leading companies supporting COVID-19 testing efforts,” said Jerry Hussong, MD, MBA, Chief Executive Officer, Sonic Healthcare USA. “Supporting the reopening of schools is paramount to COVID-19 recovery efforts; it is our social responsibility to collaborate with public health officials, school officials, and other leading private and public sector organizations. Collectively, we can quickly respond to the needs of our local communities,” added Dr. Hussong.

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 eight operating divisions and nearly eight thousand US- based employees, 330 Pathologists and serving over 30 million patients per year. Sonic Healthcare USA operates under 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.

MEDIA CONTACTS:

Sonic Healthcare USA

Dr. Jerry Hussong, MD, MBA

Chief Executive Officer

jhussong@sonichealthcareusa.com

512.531.2216

2020

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.

Sonic Healthcare USA Announces Testing Availability for COVID-19

 

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.

 

Sonic Healthcare USA Media Contact

Chief Executive Officer
Dr. Jerry Hussong, MD, MBA
jhussong@sonichealthcareusa.com 
512.531.2216

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.

 

Sonic Healthcare USA Media Contact

Chief Executive Officer
Dr. Jerry Hussong, MD, MBA
jhussong@sonichealthcareusa.com 
512.531.2216

 

2019

Effective July 1, 2019, Sunrise Medical Laboratories will introduce a new stool collection device, the Apacor Mini ParaSep for Ova & Parasite testing.

 

Mini Parasep® SF Patient Care Single Vial Device

  • Contains a formalin free alcohol based stool preservative
  • Maintains morphological features of intestinal parasites
  • Uses a smaller amount of stool for collection in one device
  • Allows for wet mount preparations, trichrome staining for trophozoites and ELISA testing for Giardia and Cryptosporidium from one sample
  • Replaces the Formalin and PVA Para-Paks

 

Additional Information

  • Testing performed Monday through Friday
  • Analytic time 24-72 hours after receipt
  • Samples transported room temperature (15-25°C) or refrigerated (2-8°C)
  • After inoculation, sample stable in collection device for 7 days
  • Empty collection devices and leaking samples will be rejected

 

Test Codes

  • Ova & Parasite one sample ............Test Code 403
  • Ova & Parasite two samples ........Test Code 4032
  • Ova & Parasite three samples ......Test Code 4033
  • Ova & Parasite comprehensive* .....Test Code 405
    *Includes O&P, Giardia and Cryptosporidium ELISA testing

 

For questions contact: Sunrise Laboratories Microbiology Department at1.800.782.0282 ext. 1110

Before applying a tourniquet, make sure you’re following the proper order of venipuncture. There are several steps to take before a tourniquet should be used. These include:

  • Confirming with the patient the amount of blood that will be drawn.
  • Putting together any equipment that may be necessary.
  • Washing hands and putting on gloves.
  • Positioning the patient correctly.
  • Finding the appropriate vein for a blood draw.

 

Once these steps have been taken, you can apply the tourniquet. It’s always a good idea to let your patient know what you’re doing while you’re doing it. This helps put them at ease. When you’re ready, put on the band using the following steps:

  1. Place the band at the back of the patient’s arm. The tourniquet needs to be flat on the patient's arm. A tourniquet should be placed 3 to 4 inches above the site of collection.
  2. Be sure not to pinch the skin or make it too tight. (When it’s tied too tight the vein can collapse.)
  3. Make a loop with the tourniquet around the patient’s arm and cross the ends.
  4. Taking one end, loop it around the cross-section, and underneath.
  5. The loop and natural compression of the cross-section will apply enough pressure to hold the band in place.
  6. Ask them if the band is too tight. If it is, you may need to start the process over.
  7. In many cases, if the vein is visible, you may not need a tourniquet at all.
  8. Remove the tourniquet as soon as blood flow is established.

Purpose To provide a brief introduction to Histology, and a clearer understanding of the process, highlighting common errors made when submitting samples.

 

Transport

  • Specimens can be transported and stored at room temperature or refrigerated.

 

Transport Medium

  • Formalin - most routine cases
  • Sterile Container - If sample is shared with micro. (nails, iud)
  • POC - For chromosome analysis or hematology (gout tophi, "GOUT")

 

Test Code

  • 601 THROUGH 618
  • 614 - POC
  • 6019 - PROSTATE
  • 92417 - DERM, IN-HOUSE
  • 66212 - MID-ATLANTIC

 

Lab Department

  • Histology

 

Methodology

  • Vacuum Infiltration Processing (VIP)

 

Sample Type

  • Human Tissue
     

Post-Collection Stability

Fixation is done at the time of specimen collection. In some cases, such as POC for chromosome analysis, the sample is kept in the refrigerator upon receipt.

 

Turn-Around Time

48 hours, if no additional stains or processes are required by the pathologist to aid in diagnosis

 

List Price

For any other pricing questions, please forward to the Sales Department.

 

Contacts

For technical questions, please contact:

Victoria, Ext. 1018

Haiedeh, Ext. 1108, or

Donna, Ext. 1011

 

For result follow-up, slide request, test add-on, to speak to a pathologist, or any other non-technical question, please contact Pathology Support:

Ellen (Lead Pathology Coordinator), Ext. 1197

Tyesha (“TYE”), Ext. 1179, or

Allyson, Ext. 1178

Sunrise Medical Laboratories is pleased to announce the introduction of QuantiFERON-TB Gold Plus assay which offers optimized analyses with tuberculosis (TB)-specific antigens that elicit both CD4+ and CD8+ T-cell responses. The new 4-tube collection sets enable a more comprehensive assessment of cell-mediated immune response to TB infection.

 

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.

 

For unincubated(Test code 21202) processing, send tubes to the lab at room temperature within 16 hours of collection.

 

For pre-incubated(Test code 21203) processing, incubate the tubes upright at 37C for 16-24 hours and centrifuge for 15 minutes at 2000-3000g. Refrigerate tubes at 2-8C.

 

The 1-tube assay(Test code 12024) requires 6ml (5ml minimum) of whole blood collected in a Hemoguard green lithium heparin tube. Invert tube gently several times. Specimen must remain at room temperature for a minimum of 15 minutes after collection before being refrigerated. Refrigerate the specimen within 3 hours of draw and transport tube to the lab the same day it is collected.

If you have any questions, please contact Customer Service at 1.800.782.0282.

Purpose

  • The D-DIMER assay is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and as an aid in the diagnosis of deep venous thrombosis (DVT) in outpatients suspected of PE or DVT.
  • Elevated levels of D-Dimer are found in clinical conditions such as DVT, PE and disseminated intravascular coagulation (DIC). D-Dimer levels also rise during the normal pregnancy but very high levels are associated with complications.
  • A negative D-Dimer result, when combined with a clinical assessment of low pretest probability, has been shown to have a high negative predictive value for DVT or PE.

 

Test Code

  • 503

 

CPT Code

  • 85379

 

Sample Type 

  • Citrate Plasma

 

Rejection Criteria  

  • Hemolyzed sample, clotted sample

 

Lab Department 

  • Hematology (Coagulation)

 

Collection Device 

  • Light blue top tube - sodium citrate

 

TAT 

  • 24 hours

 

Stability Post Collection

  • Whole blood is stable at room temp. for 4 hours.
  • Room temp. plasma is stable for 8 hours.
  • Frozen plasma is stable for 3 days.

 

Methodology

  • Turbimetric - this assay is based on the change in turbidity of a microparticle suspension that is measured by photometry.

 

Critical Results

  • Any D-Dimer>0.55 ug/ml FEU is considered critical and the client will be notified.

 

List Price 

  • Refer to Antrim. For any other pricing questions, please forward to the Sales Department. 

 

Contacts

  • For technical questions, please contact Paul Doherty, extension 1131

 

Collection Instructions

  1. Nine parts of freshly drawn venous blood are collected into one part 3.2% trisodium citrate.
  2. The tube should be gently inverted several times immediately after being drawn. Collection Instructions
  3. The specimen should be centrifuged at 2500 rpms or above for 15 minutes, or stat spin for five minutes at 5,000 to 6,000 rpm.
  4. Under filled or overfilled tube will be rejected.
  5. Frozen whole blood tube will be rejected.

 

2018

  • 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.

Patient and specimen identification is critical for accurate result reporting. Healthcare accrediting agencies (i.e., CAP) address this patient safety concern by requiring that requisitions and specimen containers be labeled with at least two unique patient identifiers. Examples of acceptable patient identifiers include:
 

  1. Patient first and last name Mandatory
  2. Patient date of birth
  3. Patient Medical Record Number
     

Both identifiers must appear on the specimen container and the accompanying requisition. To aid in timely and accurate test results, we kindly ask physicians and staff to provide the following information:
 

Specimen Label:

Please include the following:

  • Patient Name (first and last) Mandatory
  • Second Identifier (DOB, MRN, etc) Mandatory
  •  Date of Collection
     

Laboratory Requisition:

Please include the following:

  • Requesting Physician Name (first and last) Mandatory
  • Full Patient Name (first and last) Mandatory
  • Patient Date of Birth Mandatory
  • Patient Sex Mandatory
  • Date of Collection (if specimen is submitted to lab) Mandatory
  • Source of Specimen (if specimen is submitted to lab) If Applicable, Mandatory
  • Submitting Diagnosis or ICD-10 code (relevant to the type of specimen submitted and patient condition)
  • Other Relevant Information (additional clinical, billing, and insurance information, etc.)

 

The above mandatory fields are necessary even when patients are sent to Sunrise Medical Laboratories Patient Service Centers. Please ensure that specimen information on the container label matches the information on the laboratory requisition.

 

Thank you for your assistance. Your efforts will ensure accurate and timely delivery of your results.

 

Sunrise is pleased to offer a new, more convenient way to order your supplies. You can now place orders using a web portal, customized to your needs. All orders will be fulfilled by the Sunrise supply team. Your Sunrise Medical Laboratories dedicated Customer Service team is available to assist you. 

 

There are two ways to access the portal:

  1. Use the following link to gain direct access to portal: https://clients.sunriselab.com

  2. Go to www.sunriselab.com, and under “Quick Links” (on the right side of the screen) click, “Client Supply Request Portal” 

 

Once inside the portal, just enter your account number and requester name, then follow the training instructions. 

 

Complete the following steps to create a new supply request:

  1. Click Create Request. The Request dialog box is displayed.
  2. Enter data in the following applicable boxes and elements for the type of request:

 

Elements

Description

Requester

Enter the name of the person reporting the issue, requesting supplies, or requesting assistance, or enter the person to contact.

Telephone Number

Enter the phone number of the requester.

Instructions

Enter special instructions that relate to the delivery of the requested supplies, if applicable.

 

When you create a supply request, the available supply items are displayed on the Favorites and Other tabs. The Favorites tab displays supply items that are most frequently requested by your organization. The Other tab displays all other supply items available for request.

 

Complete the following steps to add items to the list of requested items:

  1. Locate the item on the Favorites or Other tab. Click the image of the item to view additional details.
  2. In the Quantity box, enter the number needed for the item. Notice the unit of measure (UOM) of the item, and ensure that you order the correct number of items.
  3. Click Add. The item is displayed on the list of requested items.
  4. Repeat Steps 1 through 3 for additional items, as needed.
  5. To remove an item from the list, click Remove.
  6. Click Confirm. The Confirmation dialog box is displayed.
  7. If edits are required, click Back to return to the Request dialog box and make the necessary changes.
  8. Click Submit

 

 

Complete the following steps to access your organization’s history and request details:

1. From the Supply Requests tab, the default view is displayed with all supply requests created in the last seven days.

2. Enter a start date and end date, and then select a status from the following status options:

  • Request number
  • Name of the requester
  • Requester’s phone number
  • Date and time the request was created
  • Status of the request
  • Items and quantities requested
  • Instructions

3. Click View Details to view the details of that request. The Request Detail dialog box is displayed with the following details, if applicable:

4. Click Back to return to the request view.

 

To contact us, please call 800.782.0282 

Attention Loudoun Medical Group clients: Effective Monday, February 5, 2018, the following urinalysis testing will be performed by the LMG Laboratory.

  • K313 Urinalysis with Reflex Microscopy
  • K314 Urinalysis with Microscopy
  • K315 Urinalysis with Reflex Microscopy and Culture
  • K318 Urogram
  • K316 Urine Microscopy

 

SPECIMEN HANDLING:

  • K313, K314, K316, K318 – Aliquot urine to Urinalysis Preservative Conical Tube
  • K315 - Aliquot urine to Urinalysis Preservative Conical Tube and Urine C&S Preservative Tube

 

The BD order numbers are as follows:

 

364953- C&S transfer straw kit: Transfer straw and 4.0mL, 13mm x 75mm Plus plastic C&S preservative tube (qty: 50/case)

 

364943- Urinalysis Transfer Straw Kit: 8mL draw PLUS Plastic conical bottom tube with preservative (qty: 200/case)

This communication is to describe a change concerning how Sunrise Medical Laboratories handles Medicare Z00.00 denials, which we instituted last Fall.

 

Specifically:

  • Z00.00 is a code that is never covered by Medicare for laboratory testing. If you submit this code, the patient will ultimately receive a full-price invoice from Sunrise Medical Laboratories.
  • In instances where Z00.00 is initially submitted, but the patient’s condition also supports additional codes that were not submitted, then you must submit a letter from your office on your practice letterhead containing the following:
  1. Patient’s name and the collection date
  2. Your Sunrise account number
  3. States, “Please remove Dx code Z00.00 from this patient encounter and replace it with _________________________________, which (is)(are) applicable to the patient and supported by the patient’s medical records, and submit to Medicare.
  4. The printed name, title and signature of the individual in your office who is requesting the change. No request will be honored without this.

 

Please fax the letter to Sunrise Billing at 888.798.6744.