Clinical Pathology Laboratories has validated a new qualitative method for detection of Group B Streptococcus (GBS), Streptococcus agalactiae, by Real-Time Polymerase Chain Reaction (PCR) to improve sensitivity and timeliness over culture-based test methods.

The American College of Obstetricians and Gynecologists (ACOG) curates guidelines for prophylaxis and treatment of GBS maternal colonization and neonatal disease and the American Society for Microbiology (ASM) maintains guidelines for laboratory practices related to detection of GBS. The ACOG and ASM guidelines note:^{1, 2}

• GBS is the leading cause of newborn infection.
• Maternal colonization of genitourinary and gastrointestinal tracts is the primary risk factor for neonatal GBS disease.
• All pregnant women should be screened for GBS colonization between 36 0/7 and 37 6/7
  weeks gestation.
• A single swab should be used to sample lower vagina and then rectum without use of
  a speculum.
• Swabs should be submitted to the laboratory within 24 hours of collection.

While culture-based methods are considered the historical standard, ASM and CDC include provisions for using PCR/NAAT for GBS screening. After broth enrichment, PCR has sensitivity given as >96%. Recent studies report variable sensitivities for culture, but this may be as low as 53 to 70%. Additionally, PCR-based testing has shorter turnaround time (TAT), 36-48 hours including enrichment.^{3, 4}

GBS Test Offering

Effective October 9, 2023, two orderable test codes for GBS detection by PCR are offered by CPL. GBS by PCR reflex to antimicrobial sensitivity testing should be limited to use in penicillin-allergic patients only. These tests are considered replacements for GBS screening by culture.

Key Notes

• GBS by PCR TAT is 36-48 hours vs. 2-3 days for culture-based screening.
• The sample type and collection devices remain the same with a single vaginal/rectal swab submitted in transport media.
• Swabs are inoculated in LIM enrichment broth and incubated 18-24 hours as required by ASM guidelines.²
• The CPL assay includes an internal control to prevent false-negative results.
• This is a custom designed TaqMan real-time PCR assay on the Thermofisher Quantstudio platform validated by CPL.

References

1. Prevention of Group B Streptococcal Early-Onset Disease in Newborns. Committee Opinion No. 797. American College of Obstetricians and Gynecologists. Obstetrics and Gynecology 2020 Feb;135(2):e51-72.
2. Filkins L et al. for ASM. Guidelines for Detection and Identification of Group B Streptococcus. J Clin Microbiol. 2020 Dec 17;59(1):e01230-20.
3. Shin JH, Pride DT. 2019. Comparison of three nucleic acid amplification tests and culture for detection of group B Streptococcus from enrichment broth. J Clin Microbiol 57:e01958-18. https://doi.org/10.1128/JCM.01958-18. 
4. H. Dele Davies, Mark A. Miller, Sebastian Faro, Dan Gregson, Sue C. Kehl, Jeanne A. Jordan, Multicenter Study of a Rapid Molecular-Based Assay for the Diagnosis of Group B Streptococcus Colonization in Pregnant Women, Clinical Infectious Diseases, Volume 39, Issue 8, 15 October 2004, Pages 1129–1135, https://doi.org/10.1086/424518.

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Clinical Pathology Laboratories (CPL) is committed to providing effective, appropriate, and timely patient care by ensuring that our testing reflects medical standards and current guidance. In an audit of our hematology processes, we identified a quality improvement opportunity concerning ordering, timeliness, and resource utilization for the complete blood count (CBC) Unit Code 1007, CBC WITH MANUAL DIFFERENTIAL and Unit Code 1001, MANUAL DIFFERENTIAL. These Unit Codes require a manual WBC differential on a CBC, even if not indicated for qualitative or quantitative abnormalities identified by analyzer expert systems or department procedures. WBC differentials performed by automated instrumentation at CPL offer higher precision, superior turnaround time, and improved clinical sensitivity in distinguishing normal from abnormal samples when compared to manual testing.

Effective July 10, 2023, Unit Code 1007, CBC WITH MANUAL DIFFERENTIAL and Unit Code 1001, MANUAL DIFFERENTIAL will be designated as CBC W/AUTO DIFF RFLX SMEAR REVIEW and AUTO DIFF REFLEX SMEAR REVIEW, respectively. The hematology lab will perform and report an automated WBC differential, unless automated flagging or procedure determine that a manual differential is required. When the data identifies an abnormality requiring a smear review, a manual differential will be performed and any morphologic abnormalities will be reported. If the findings meet laboratory-established criteria for pathologist review, the slide will be reviewed by a hematopathologist who will report significant findings, provide interpretation, and recommend further studies as appropriate. This change will improve timely reporting of essential and complete hematology data. The laboratory welcomes clinician requests for smear reviews to address clinical or analytic concerns. For more information, please contact your local CPL office and/or account representative.

References:

1. Pierre RV. Peripheral blood film review. Clin Lab Med. 2002; 22(1):279-297.
2. M. E. Kurt-Mangold et al. Clinical Utility of Ordered Pathology Blood Smear Reviews - an Overused Resource? Clin. Lab. 2018; 64.
3. B. Bain Diagnosis from Blood Smear N Engl J Med 2005; 353:498-507

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CPL now supplies the Vacuette gel separator tubes from Greiner for serum collections. In response to supply chain issues, we have validated the Vacuette gel tube with clot activator as equivalent to the Vacutainer Serum Separator (SST) tube (also known as “Tiger top” tubes) from Becton-Dickinson. In our evaluation, we have further determined that the tube tends to slide more freely in and out of needle holders for ease of use. In the future, your request for collection supplies may be filled with either tube, but over time expect to transition to the Vacuette collection tube.

Below is an image of the Vacuette gel separator tube you may receive when an order is placed for SST or Tiger-top tubes.

The tube volume is 8.0 mLs, has a red cap with a yellow ring and is comparable to the BD Vacutainer tube (volume 8.5 mLs).

Specimen Handling Instructions:

Invert 5-10 times immediately after collection. Incomplete or delayed mixing may result in delayed clotting or post-clotting fibrin formation. Tubes must be allowed to clot upright for 30 minutes and centrifuged within 2 hours of collection.

Supply Ordering Instructions:

Please order as normal, however, list individual counts versus tray counts so orders may be filled appropriately.

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Effective May 8th, 2023, Clinical Pathology Laboratories (CPL) is pleased to announce a change in the method and analytic platform for Thyroglobulin Antibody (Anti-Tg) and Thyroid Peroxidase Antibody (Anti-TPO). The new methodology is electrochemiluminescence immunoassay (ECLIA).

The change in instrumentation and methodology will result in changes to reference range and the clinical reporting range of the two assays.

Reference Range Changes:

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Clinical Pathology Laboratories (CPL) has validated the Diasorin LIAISON® Meridian H. pylori Stool Antigen(HPSA) test to replace the TechLab® H. pylori CHEKTM test.

• The Diasorin LIAISON® Meridian HPSA test and TechLab® H. pylori CHEKTM test are FDA approved.
  • Diasorin LIAISON® Meridian HPSA is a chemiluminescent immunoassay (CLIA) method.
  • TechLab® H. pylori CHEKTM is an enzyme immunoassay (EIA) method.
• The Diasorin® and TechLab® methods are analytically equivalent according to CDC and CPL evaluations.
• CPL has confirmed the Diasorin® method to be highly sensitive and specific.

Specimen Acceptability

The Diasorin LIAISON® Meridian HPSA test specimen requirements are:

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Effective March 27, 2023, Clinical Pathology Laboratories (CPL) will adjust the reference range for urinalysis red blood cell count (RBC) as given in the chart below. This change will align CPL’s reference range with that suggested by American Urological Association (AUA) and Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) guidelines concerning microhematuria. The guidelines state:

“Clinicians should define microhematuria as ≥3 red blood cells per high-power field on microscopic evaluation of a single, properly collected urine specimen.”

Please use the link below to view the AUA/SUFU Guideline:

Microhematuria: AUA/SUFU Guideline (2020) - American Urological Association

Reference Range Change:

Microhematuria is defined as red blood cells in a urine sample that are only detected microscopically. Causes of microhematuria include, but are not necessarily limited to, the following:

• Urinary tract infection
• Menstruation
• Certain medications
• Vigorous exercise
• Benign prostatic hyperplasia
• Urolithiasis
• Intrinsic renal disease
• Urethral strictures
• Urinary bladder, renal or prostatic neoplasms including malignancy

References

Barocas DA, Boorjian SA, Alvarez RD, Downs TM, Gross CP, Hamilton BD, Kobashi KC, Lipman RR, Lotan Y, Ng CK, Nielsen ME, Peterson AC, Raman JD, Smith-Bindman R, Souter LH. Microhematuria: AUA/SUFU Guideline. J Urol. 2020 Oct;204(4):778-786. doi: 10.1097/JU.0000000000001297. Epub 2020 Jul 23. PMID: 32698

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Clinical Pathology Laboratories (CPL) has implemented the Gulf Coast Scientific^TM PyloPlus® Urea Breath Test (UBT) for detection of Helicobacter pylori to replace the Meridian/Otsuka^TM BreathTek® UBT. The Meridian/Otsuka^TM assay has been discontinued by the manufacturer. CPL’s validation has determined that:

• The PyloPlus® UBT and BreathTek® UBT use the same methodology, infrared spectrophotometry of CO2 isotopes in breath samples before and after ingestion/metabolism of 75mg of ¹³C Urea in a citric acid solution.
• The performance characteristics of the PyloPlus® UBT and BreathTek® UBT tests are equivalent.
• As results are qualitative (Positive/Negative), the result reporting and reference interval
  are unchanged.
• There are minor changes to the collection kit and instructions. Those are given in detail below.

Effective March 1, 2023, distribution will begin transitioning to PyloPlus® UBT collection kits. Clients may be supplied with the PyloPlus® or BreathTek® UBT collection kits depending on availability of supplies. During this transition, the BreathTek® UBT collection devices will be run on the Meridian/Otsuka platform and incoming PyloPlus® UBT will be run on the Gulf Coast Scientific spectrophotometer platform without delays to testing. CPL has validated PyloPlus® UBT for the following tests.

Pediatric Specimens

Gulf Coast Scientific^TM PyloPlus® UBT is an FDA-cleared test on adult patients 18 years or older. CPL
has validated the method for pediatric patients, <18 years of age. For pediatric samples, there will be an added message on the report indicating that the performance characteristics of the assay have been validated by CPL which is authorized to perform high-complexity laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Please review your report for specific method notes.

Gulf Coast Scientific^TM PyloriPlus® UBT Procedure

1. Materials provided in each PyloPlus Kit:

1. One pouch of ¹³C-urea powder
2. One packet of citric acid flavoring
3. Test Instructions
4. One Quick Reference Instructions (QRI)
5. Two breath collection bags, one blue bag for the BASELINE sample and one red bag for the POST sample
6. One drinking straw
7. One sample transport bag

2. Materials needed, but not provided

1. A 15 minute timer
2. Potable water
3. Cup able to measure 100mL of water

3. Patient Preparation

1. The patient should have fasted at least 1 hour before administering the PyloPlus Kit.
2. Antimicrobials/antibiotics, Proton Pump Inhibitors (PPI), Bismuth preparations and Histamine Receptor antagonists (HRA) are also known to suppress H. pylori and may produce false-negative results. Any positive, while on those preparations should be considered a true positive. Upon the advice of their provider, patients should refrain from taking:
   1. Antibiotics (e.g., Flagyl, Metronidazole): 2 weeks
   2. PPI’s (e.g., Nexium, Prevacid, Zegerid and Prilosec): 2 weeks
   3. Bismuth preparations (e.g., Pepto-Bismol, Kaopectate and Pink Bismuth): 2 weeks
   4. HRA ’s (e.g., Pepcid, Zantac, Axid, Tagamet): 2 days

4. Step-By-Step Procedure

1. Time intervals listed in the following step-by-step procedure are critical.
2. Verify that the patient has been prepared for the test as specified above. If the patient is not appropriately prepared, contact the ordering clinician for further instructions.
3. Open the PyloPlus Kit, which should contain all the materials listed in 2.1. Label each breath collection bag to maintain patient identification using a felt tip permanent marker. Include the specimen date and time of collection.
4. Collect the BASELINE breath sample according to the following steps:
   1. Pick up the blue breath collection bag.
   2. Remove the twist-off cap from the mouthpiece of the breath collection bag.
   3. Instruct the patient to: (1) breathe normally; (2) take a deep breath then hold their breath for 10 seconds; (3) partially exhale into the room, before fully exhaling into the mouthpiece of the bag.
   4. Replace the cap firmly on the mouthpiece of the bag.
   5. NOTE: if the patient has not held their breath for 10 seconds, or does not fill the bag completely, there is a possibility a test result will not be obtained.
   6. NOTE: The bag is not fully closed if the cap does not click into place. Not fully closing the bag may cause the breath sample to leak, invalidating the result.
5. Prepare the ¹³C-urea solution no more than 50 minutes before administering it to the patient. Urea slowly decomposes in water.
   1. Pick up the citric acid flavoring packet and tear open. Place contents of flavoring packet into ¹³C-urea pouch by tearing open the pouch and carefully pouring contents of the flavoring packet into the open ¹³C-urea pouch.
   2. Add approximately 100 mL drinking water (about 1/3 full) to the ¹³C-urea pouch.
   3. Close the Ziplock feature of the ¹³C-urea pouch securely and shake the mixture for 30 seconds.
   4. Instruct the patient to drink all of the drug solution with the straw provided directly from the ¹³C-urea pouch, without stopping. Advise the patient NOT to ‘rinse’ the inside of their mouth with the drug solution before swallowing. Discard the straw after the patient has finished drinking the drug solution.
6. Set the timer for 15 minutes. The patient should sit quietly and should not eat, drink, or smoke during the 15- minute interval.
7. After 15 minutes have elapsed, pick up the red (pink) breath collection bag. Collect the POST-SAMPLE breath sample according to the instructions above.

References:

PyloPlus® UBT Kit for PyloPlus® UBT System Breath Test for Detection of H. pylori. Package Insert. Gulf Coast Scientific^TM. REV_B

Printable Version

Clinical Pathology Laboratories (CPL) is experiencing a national shortage of the Meridian/Otsuka Urea Breath Test (UBT) for Helicobacter pylori detection. Collection kits are on backorder and requests for resupply may not be possible for a short period of time. In addition, certain patient service centers (PSC’s) may not have collection supplies. Testing will continue to be performed at CPL subject to UBT kit availability. CPL is validating an alternative UBT method and collection device, and expects to reestablish client and PSC supply very quickly. Further details will follow.

In the interim, please consider:

1. Contact your account executive for collection device availability and anticipated resupply with the current or new device.
2. Have patients call their local PSC prior to scheduling testing to assure that collection supplies are available on site.
3. Consider H. pylori Stool Antigen (HPSA) test as an alternative for the diagnosis of H. pylori infection. While the collection of HPSA requires submission of a stool sample and may be more challenging for some patients, published data shows excellent sensitivity and specificity.

NOTE: CPL has found that >90% of patients co-collected with UBT and Stool Antigen testing have concordant results.

Please contact your local Account Executive with any questions.

Printable Version

Dear Valued Client,

Clinical Pathology Laboratories announces the addition of Drs. Vivian Hathuc and Hong Jiang to our team of diagnostic pathologists and laboratory leaders. We are excited to bring them aboard and intend to introduce them to the medical community at the earliest opportunity.

Dr. Hathuc will join CPL from her current role as assistant professor of pathology and associate residency program director at St. Louis University School of Medicine in Missouri. Dr. Hathuc completed her residency in Anatomical and Clinical Pathology at Wake Forest University and served two fellowships at University of Michigan—Surgical Pathology and Hematopathology. She has experience with and is published in cutaneous lymphoproliferative disorders. 

Dr. Jiang will join CPL from her current role at Dahl-Chase Cancer Center in Maine. She completed an Anatomical Pathology residency at the National Institutes of Health in Bethesda, Maryland where she was chief resident. This was followed by fellowships in Surgical Pathology at the Mayo Clinic in Rochester, Minnesota and Dermatopathology at the University of Virginia. Prior to pathology training, Dr. Jiang completed Dermatology residency and a masters program in Immunology in China.

As the pathology team is recruited and on-boarded, we continue to invest in the surgical pathology capabilities at CPL. We have validated a large menu of antibodies for immunohistochemistry studies, offer chromogenic and fluorescence in-situ hybridization studies and, with our Sonic Reference Laboratory partner, have somatic mutation and microsatellite instability testing available in Austin. With our fellow Sonic laboratories, ProPath in Dallas and LMC in Las Vegas, the antibody libraries are exhaustive and the experience and expertise in PD-L1 and other prognostic or companion markers is among the largest in the country. In cytopathology, we have invested in new PCR platforms for scalability, productivity, throughput and exceptional turnaround time for the ancillary testing that accompanies the more than 1600 Paps tests that we serve to the Women’s Health program every day.  

We are streamlining laboratory services that support the triple aim of better patient experience, better health of populations and a sustainable cost. We embrace our obligation to collaborate with the medical community to continuously improve our services and the health of our communities.

Please do not hesitate to contact your sales and service teams directly with any further questions.

Sincerely,

Mark Silberman, MD
President

Clinical Pathology Laboratories

Printable Version

Date: August 12, 2022

To: CPL Client

From: Compliance Department

Re: Annual Notice to Physicians

Clinical Pathology Laboratories (CPL) is providing annual notification to our clients of the Medicare policies governing the ordering and reimbursement of laboratory tests. CPL is committed to promoting awareness of and adherence to these policies. In accordance with the Office of the Inspector General’s (OIG) Compliance Program Guide for Clinical Laboratories, we are providing the following information about Medicare requirements:

Medicare Medical Necessity Policy

Medicare will only pay for tests that meet the Medicare definition of “medical necessity”. Medicare may deny payment for a test that the physician believes is appropriate, such as a screening test, which does not meet the Medicare definition of medical necessity.

Medicare Laboratory National Coverage Determinations (NCDs) and Local Coverage Determinations (NCDs)

Coverage determination policies define medical conditions through the inclusion of a list of ICD (diagnosis) codes for which these tests are covered or reimbursed by Medicare. HIPAA regulations require ICD codes to be present on each claim filed. These codes must also be documented in the patient’s medical record.

NCDs: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/LabNCDsICD10.html

LCDs: https://www.novitas-solutions.com Novitas Solutions Jurisdiction H

Frequency Limitations for Laboratory Tests

Certain laboratory tests have specific frequency limitation requirements. The limitations may apply to tests from the laboratory NCDs and LCDs.

Medicare Preventive Screening Laboratory Tests

Certain preventive screening laboratory tests are covered services for Medicare beneficiaries. Benefit coverage is specific for each service, diagnosis codes, coverage requirements, and frequency limitations.

https://www.cms.gov/Medicare/Prevention/PrevntionGenInfo/medicare-preventive-services/MPS-QuickReferenceChart-1.html

American Medical Association (AMA) Organ or Disease-Oriented Panels

The AMA panels were developed for coding purposes only and should not be interpreted as clinical parameters. Organ and disease-oriented panels will only be paid by Medicare when all tests within the panel are deemed medically necessary by Medicare.

https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c16.pdf

Section 90.2 – Organ or Disease-Oriented Panels

Reflex Testing

Reflex testing occurs when initial test results indicate that a second related test is medically appropriate or required by state, regulatory, or accreditation standards. Most tests can be ordered without a reflex. Find details at https://www.cpllabs.com/test-directory

Advance Beneficiary Notice of Non-Coverage (ABN)

• Limited Coverage – An ABN is required if the diagnosis is not covered

• Frequency Limit - An ABN is required at each encounter for frequency limited tests

• Non-Coverage – An ABN is required for experimental or research use tests or tests designated by Medicare as non-covered

https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs.html

Manual 100-04 Medicare Claims Processing Manual

Chapter 30 Financial Liability Protections

Section 50 Form CMS-R-131 Advance Beneficiary Notice of Non-Coverage (ABN)

2022 Medicare Clinical Laboratory Fee Schedule (CLFS)

Current and previous fee schedules are found at:

https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Clinical-Laboratory-Fee-Schedule-Files.html

Additional details can be found at PAMA regulations.

https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/PAMA-Regulations.html

Medicare Part B National Correct Coding Initiative (NCCI) Edits

The Medicare NCCI was implemented to promote national correct coding methodologies and to control improper coding leading to inappropriate payment.

https://www.cms.gov/Medicare/Coding/NationalCorrectCodInitEd/index.html

CMS Signature Requirements

According to CMS' guidance on laboratory services documentation requirements, unsigned requisitions alone do not support physician intent to order. Physicians should sign all orders for diagnostic services to avoid potential denials.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/LabServices-ICN909221-Text-Only.pdf

Contact Information

The Medical Directors and other pathologists are available to discuss appropriate testing and test ordering. Please call (512) 339-1275 or (800) 595-1275 for assistance.

You may also contact our Compliance Department at compliancedept@cpllabs.com.

Please review this notice with all appropriate staff.

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Effective January 9, 2023, Clinical Pathology Laboratories (CPL) is pleased to announce a change in the method and analytic platform for Vitamin D, 25 OH (Hydroxyvitamin D). This change provides increased efficiency, optimized handling of low-volume specimens, and improved turnaround time and test capacity.

The new methodology is competitive electrochemiluminescence binding assay with cross-reactivity to Dihydroxyvitamin D blocked by a specific monoclonal antibody. CPL has extensively validated the method including correlation with the laboratory’s Hydroxyvitamin D by liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. In addition, the new method has been standardized against and is traceable to the National Institute of Standards and Technology Standard Reference Material 2972.

The change in instrumentation and methodology will not affect the current interpretive ranges used by CPL.

The new methodology will allow for an analytical measuring range of 6 - 120 ng/mL without dilution, and clinical reporting range up to 240 ng/mL with an automatic dilution by the instrumentation. The current methodology has an analytical measuring range of 4 - 150 ng/mL. 99.9 % of results fall within the 6 - 240 ng/mL range.

Vitamin D is a fat-soluble hormone precursor that is biologically inert and must undergo two successive hydroxylations in the liver and kidney to form the 1,25-Dihydroxyvitamin D form that affects calcium metabolism and bone mineralization. The determination of the vitamin D sufficiency status is performed using a 25-Hydroxyvitamin D (Vitamin D, 25 OH) assay while 1,25-Dihydroxyvitamin D assessment is primarily indicated for evaluation of hypercalcemia and for assessing patients with renal failure.

The two main forms of Vitamin D are D2 and D3. Vitamin D2 cannot be synthesized by the human body and must be taken in with food or supplements. In contrast, Vitamin D3 is produced in the skin by exposure to sunlight. Vitamin D deficiency can lead to bone-malformation (rickets), underutilization of dietary calcium, muscle weakness, and reduced bone mass.

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Dear Valued Client,

Clinical Pathology Laboratories is excited to announce the addition of Dr. Kim Monnin and Dr. Zhenjian Cai to our distinguished Pathology staff. Dr. Cai will join CPL from his current service as faculty in the Department of Pathology at the University of Texas Health Science Center/McGovern Medical School. He serves full-spectrum anatomic and surgical pathology, specializing in gastrointestinal pathology and hepatology. Dr. Monnin is currently serving as Medical Director of Hematopathology at CPL, providing anatomic and clinical pathology professional service and supervision of the Hematology and Flow Cytometry laboratories. She brings continuity in medical services and a deep understanding of the outpatient and hospital medical community and patient populations.

Dr. Monnin completed Fellowships in Hematopathology at the University of New Mexico and Surgical Pathology at the University of Iowa. She is certified in Anatomic and Clinical Pathology with a subspecialty certification in Hematopathology. She is native to Austin, Texas, and has served this medical community since 2012.

Dr. Cai completed a Fellowship in GI Pathology at Mount Sinai/Icahn School of Medicine in New York and a residency in Anatomic and Clinical Pathology at Case Western Reserve, where he served as Chief Resident. He is board certified in Anatomic and Clinical Pathology. At UTHSC in Houston, he is the interim director of the GI/Liver service.

As we implement our new pathology strategy, CPL maintains a comprehensive anatomic and clinical pathology facility. Our anatomic pathology is further nested with full-service on-site flow cytometry, microbiology, hematology, and clinical chemistry. CPL offers an extensive immunohistochemistry menu for both the outpatient and hospital setting on multiple shifts, offers stat services, and hosts state-of-the-art digital platforms. We integrate cytopathology with surgical pathology, which is staffed 24/7 to include grossing on three shifts. We perform more than 1600 Paps/day with next-day TAT in the majority of cases. We offer both PCR and TMA methods for HPV and perform thousands of out-of-vial tests for STIs each day. Our testing is performed in our 100,000+ SF facility in Austin, supported by more than 40 couriers and 180 phlebotomists. We are streamlining laboratory services that support the triple aim, including better health for patients and populations at a sustainable cost. We believe efficiency, scalability, integration, and value are essential to delivering meaningful, impactful laboratory intelligence.

Please do not hesitate to contact your sales and service teams directly with any further questions.

Sincerely,

Mark Silberman, MD
President

Clinical Pathology Laboratories

Printable Version

Dear Valued Client,

Clinical Pathology Laboratories is pleased to announce the addition of Dr. Christine Burgess and Dr. Shannon Kratzer to our Pathology staff. Incorporating Drs. Burgess and Kratzer into our laboratory team ensures continuity in medical services and reinforces CPL and Sonic Healthcare’s vision of Medical Leadership. Our Medical Leaders interpret diagnostic clinical and anatomic pathology testing, engage in clinical consultation, supervise laboratory departments, and assure quality, accuracy and timeliness in delivery of medical intelligence.

Dr. Burgess is Fellowship trained in Clinical Microbiology and Hematopathology from Emory University and is board certified in Clinical Pathology with a subspecialty certification in Hematopathology. She is native to Austin, Texas and has serviced this medical community since 2007. Dr. Burgess will continue to lead as our Medical Director for Chemistry, Hematopathology, Microbiology, and Molecular.

Dr. Kratzer completed a Fellowship in Cytopathology from Indiana University and is board certified in Anatomic and Clinical Pathology with a subspecialty certification in Cytopathology. He has served this laboratory since 1998. Dr. Kratzer will continue to lead our Women’s Health initiative with a strong focus on Breast Pathology and Gynecologic Cytopathology with expertise in gynecological disorders.

Aside from clinical service and supervision, Drs. Burgess and Kratzer are essential subject matter experts in disease states, diagnostics and clinical requirements as CPL formulates its strategic goals. They fortify our focus on Value-Based Medicine programs, Population Health Management, and Diagnostic Centers of Excellence. Their addition to the team demonstrates our commitment to providing outstanding anatomic and clinical pathology services to our medical communities by building a best-in-class pathology cohort.

CPL looks forward to continuing to enhance our premier clinical and anatomic pathology services for our clients and their patients. Do not hesitate to contact your sales and service teams directly with any further questions.

Sincerely,

Mark Silberman, MD
President
Clinical Pathology Laboratories

Printable Version

Clinical Pathology Laboratories is proud to announce the availability of enhanced reports for allergy testing, effective 12/08/2022. CPL has validated a report routine that automatically generates and stores the enhanced report for the subset of testing on an accession that includes any allergen specific IgE testing, including regional panels, food panels, pediatric panels or individually ordered allergens. The reports are available in CPL’s Atlas laboratory portal. In addition, certain electronic medical records are programmed to receive encoded, embedded PDF documents and may be able to download the enhanced report. For more information about how to receive this service, please contact your account executive.

Additional information about the report:

• These are specialized allergen specific IgE reports, enhanced to optimize data display. In the enhanced report, allergens are grouped based on clinical relatedness.
• For enabled PDF readers, highlighted allergen names provide links to additional educational content hosted at www.allergyinsider.com/allergeninfo. This is hosted by ThermoFisher Phadia Scientific, the manufacturer of the allergen specific IgE testing platform. The linked content provides information on clinical implications, common symptoms, and cross-reactivities. CPL does not have editorial control over linked content.
• Additional testing performed on the patient accession are not given in this enhanced report.

The information from the enhanced report and linked content does not constitute medical advice. A clinical diagnosis should be made only by the clinician after all clinical and laboratory findings have been evaluated in context of the patient’s history, allergen exposure and symptoms. ImmunoCAP™ Specific IgE Allergen codes are specific for ImmunoCAP products. The comments generated herein are copyright protected and may only be used together with ImmunoCAP results. No liability is accepted with the use of the comments.

Please contact your local sales representative for more information and how to receive the new enhanced reporting.

Please see the sample report in printable version below.

Printable Version

As part of our comprehensive plan for molecular testing for sexually transmitted infections in reproductive and sexual health, Clinical Pathology Laboratories (CPL) will be transitioning Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) testing to the Roche COBAS® 6800/8800 platform.

CPL has validated the Roche platform and determined that:

• The Roche® method is an FDA-approved nucleic-acid amplification technology (NAAT).
  • The Roche® method is qualitative real-time polymerase chain reaction (PCR). (The prior method uses qualitative target capture and Transcription-Mediated Amplification (TMA), an alternate NAAT method).
• The Roche® method is considered analytically equivalent to other NAAT methods according to CDC and CPL evaluations.
• The Roche® method has been confirmed to be highly sensitive and specific.
• The collection instructions and handling of the Roche collection swab and the prior method are similar, and the stability is equivalent.

With this notification, client training, and user experience, CPL is working to ensure seamless transition to the Roche collection device.

Phase 3: Swab Specimens

Effective January 9, 2023. Clinical Pathology Laboratories will be transitioning from the Hologic Aptima® testing platform to the Roche COBAS® 6800 and 8800 for the detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) for swab specimens.

As part of the transition, select test or panel names will be edited to NAAT (nucleic-acid amplification technology) which includes both polymerase chain reaction (PCR) and transcription-mediated amplification (TMA) target amplification technologies. Order codes will remain the same for the tests affected in this phase.

Change in Collection Device

Beginning in January, distribution will begin transitioning from Aptima® Unisex Swab (Blue Aptima) and Aptima® Multitest (Orange Aptima) collection devices to COBAS® PCR media Dual-Swab collection devices.

Important Note: During and after the transition, if CPL receives Aptima collection devices they will continue to be run on the Hologic platform without delays to testing. Please contact your local CPL facilities for supplies. For more information about this transition, your CPL Account Representative is briefed and prepared to address your questions or concerns.

Important Note: Effective 1/9/2023, CPL will accept Roche COBAS® PCR media Dual-Swab for Bacterial Vaginosis by PCR (Order code 3920) and Candida by PCR (Order code 3914) in addition to the currently accepted Hologic Aptima, Eswab, or liquid-based cytology collection devices.

The following order codes will be affected by Phase 3 of the transition:

Distribution

Your CPL Account Representative will provide supplies to include the new collection devices as previously. There will be no change in the ordering or distribution process.

As a reminder, CPL has previously implemented the following changes related to molecular testing:

Phase 1: Urine

Effective September 1, 2022. See previously published client communication https://www.cpllabs.com/wh-testing-roche-cobas

Phase 2: ThinPrep® and SurePath™

Effective October 17, 2022. See previously published client communication https://www.cpllabs.com/wh-testing-roche-cobas-ph2.

FDA Approved/Cleared Status

The performance characteristics for the Roche COBAS® CT/NG and TV test have been evaluated and approved by the FDA for COBAS® PCR Dual-Swab collection devices from endocervical, vaginal, anorectal, and oropharyngeal sources for CT/NG and endocervical and vaginal sources for TV. CPL has verified these performance characteristics.

CT/NG and TV tests from male penile urethral/meatal swabs using the COBAS® PCR media Dual-Swab collection devices will be performed using a laboratory-developed test based on Roche COBAS® CT/NG and TV method. As a laboratory-developed assay, this testing will include an LDT disclaimer Indicating that the performance characteristics of the assay have been validated by the performing laboratory as authorized for high complexity laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Please review your report for specific method notes.

Please contact your CPL Account Representative should you have any questions regarding these changes.

References:

1. cobas CT/NG Qualitative nucleic acid test for use on the cobas 6800/8800 Systems. Package Insert. Roche Diagnostics. 07998007001-04EN.
2. cobas TV/MG Qualitative nucleic acid test for use on the cobas 6800/8800 Systems. Package Insert. Roche Diagnostics. 08308535001-03EN

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Dear Valued Client,

As part of Sonic Healthcare USA's strategic vision, we are pleased to announce the appointment of Mark Silberman, MD, as the President of Clinical Pathology Laboratories (CPL). Dr. Silberman has served CPL as the Laboratory Director since 2007. 

Dr. Silberman's appointment reinforces CPL and Sonic Healthcare's vision of active and involved medical leadership, focusing on best practices with a strong emphasis on standardization, quality metrics, and laboratory effectiveness to align the laboratory with the aim of improved healthcare in our communities. With this focus, CPL is dedicated to processes that continue to establish and support Value-Based Medicine, Population Health Management, and Diagnostic Centers of Excellence, and we are investing in digital technologies and solutions for healthcare insights. This leadership change demonstrates our commitment to providing outstanding anatomic and clinical pathology services to our medical communities.

In addition to Dr. Silberman's appointment, CPL is building a select group of pathologists and scientists who share the vision of our value proposition in addition to the diagnostic excellence that they will bring to our medical communities and patients. We will be communicating new pathologist appointments in the near future.

With Dr. Silberman's appointment as President, Bobby Smithson is transitioning to the role of Chief Operating Officer. Bobby has been with CPL since 2007 and has a distinguished laboratory career spanning over 30 years in diagnostic medicine.

Bobby's enduring commitment to providing quality care to CPL's many patients and providers has been the cornerstone of success for CPL. Bobby's leadership through the pandemic and beyond demonstrates a tireless and comprehensive commitment to excellence in operational, quality, medical, business, and compliance facets of laboratory medicine. His transparent leadership style has provided vision, clarity, and effectiveness to CPL's operations. As Chief Operating Officer, Bobby will play an essential role in leadership continuity and operational direction for CPL.

Through this leadership change, CPL looks forward to continuing to enhance our premier clinical and anatomic pathology services for our clients and their patients. Do not hesitate to contact your sales and service teams directly with any further questions.

Sincerely,

Jerry Hussong, MD, MBA

Chief Executive Officer

Sonic Healthcare USA

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Effective December 12, 2022, Clinical Pathology Laboratories (CPL) is pleased to announce the consolidation of components of TORCH testing onto a single test system. This consolidation increases efficiency, optimizes handling of low volume specimens, and offers improved turnaround time and throughput.

As a result of this instrumentation change, providers will see changes in methodology, reference ranges, and reporting units used to describe Non-reactive (Negative), Borderline (Equivocal), and Reactive (Positive ) results. It is important to keep in mind that values determined on patient samples by different methodologies cannot be directly compared to one another.

The new method utilizes the electrochemiluminescence immunoassay (ECLIA) methodology.

The tests in a TORCH panel are used to help diagnose infections that could cause harm to a baby during pregnancy. The CPL TORCH Panels include testing for:

• Toxoplasmosis: This infection is caused by a parasite commonly picked up from cat stools. Fetuses may be affected in utero via transplacental infection to produce congenital toxoplasmosis. If untreated, it can cause blindness, deafness, seizures, and intellectual disability.
• Rubella: Also called German measles, this is a viral infection that can easily be passed from person to person through sneezing or coughing. Rubella is less common today because standard MMR vaccination offers protection against it, however, the virus may be passed to the fetus, which can cause miscarriage, premature birth, or congenital rubella syndrome.
• Cytomegalovirus (CMV): CMV is a type of herpes virus and is the most common congenital infection in babies. Mothers can get CMV by sexual contact or contact with bodily fluids, such as saliva from a person who has CMV. CMV can have long-term consequences in babies, including problems with vision, hearing, and mental development.
• Herpes simplex virus (HSV): Pregnant people can can acquire genital herpes simplex virus through sexual contact with an infected individual or through reactivation of latent virus. Virus can be passed to the developing fetus transplacentally or during delivery. Congenital HSV can cause low birth weight, miscarriage, and preterm birth. Perinatal infection may cause lesions that affect skin, eyes, and mouth, or in rare cases, can cause serious brain and organ damage.

Order Codes Affected:

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When collecting Pap or sexually transmitted infection (STI) testing specimens, use of warm water is preferred over any lubricant. If lubricants must be used, apply no more than a pea size amount to the outer curve of the speculum, avoiding any application near the edges or lip of the speculum, and smoothly insert without withdrawing and reinserting. Be vigilant for and avoid lubricant contaminating or coating the sampling area.

Recommended Lubricants

The following lubricants are compatible with Hologic Aptima® and Roche cobas® molecular platforms. In addition, those provided in this recommended list have decreased interference with the Hologic Thinprep® Pap smear method.

Lubricants Not Recommended

Please avoid using any products including lubricants, creams, gels, and hygiene products containing CARBOMERS prior to collection of urogenital NAAT testing specimens. The lubricants that should be avoided prior to urogenital specimen collection are given below.

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Dear CPL Client,

We are happy to announce that effective November 7, 2022, Clinical Pathology Laboratories will provide computer-guided screening for all liquid-based pap tests. The Thinprep® Imaging System was FDA approved in June 2003, and the Becton-Dickinson FocalPoint™ GS Imaging System was FDA approved in December 2008. CPL has extensive experience with this technology dating from 2006 for Thinprep® and 2010 for FocalPoint™. With Dual Review technique, the Thinprep® Imaging System scans every cell in the Pap slide for prioritized screening by the cytologist. Dual Review is shown to provide increased sensitivity and specificity, as well as improved disease detection over manual review.1-3 The FocalPoint™ GS Imaging System comprises computerized Pap prescreening with a risk ranking method to focus cytologist review on cells and cases at increased risk for significant epithelial lesions. Use of this system increased sensitivity for low- and high-grade squamous intraepithelial lesions without increasing equivocal diagnoses.

Both imaging technologies improve detection of small isolated dysplastic cells which may be missed by manual review alone. In addition, imaging technologies offer improved turn-around time and cytologist productivity to mitigate the impact of a shrinking workforce. Uniformly applying computer-assisted screening will benefit patients and their physicians, while streamlining laboratory workflow.

This transition will require a change in CPT codes. There may be an adjustment to laboratory charges. Please contact your account representative with any questions or concerns you may have.

* For more information, please review test catalog at https://www.cpllabs.com/test-directory/ or contact your account executive.

References:

1. Dziura B., et al. Performance of an imaging system vs. manual screening in the detection of squamous intra epithelial lesions of the uterine cervix. Acta Cytol. 2006;50(3):309-11.
2. Lozano R., et al. Comparison of computer-assisted and manual screening of cervical cytology. Gynecol Oncol. 2007;104(1):134-8. doi:10.1016/j.ygyno.2006.07.025.
3. Miller, F., et al. Implementation of the ThinPrep imaging system in a high-volume metropolitan laboratory. Diagn Cyto-pathol. 2007;35(4):213-7. doi:10.1002/dc.20627.
4. Chivukula, M., et al. Introduction of the ThinPrep Imaging System (TIS): experience in a high volume academic prac-tice. CytoJournal. 2007;4:6. doi:10.1186/1742-6413-4-6.
5. Ha, S., et al. Effectiveness of the ThinPrep imaging system in the detection of abnormal cervicovaginal cytology: a practical experience in Korea. Acta Cytol. 2013;57(2):159-63. doi: 10.1159/000345103.
6. Wong R, Levi AW, Harigopal M, Schofield K, Chhieng DC. The positive impact of simultaneous implementation of the BD FocalPoint GS Imaging System and lean principles on the operation of gynecologic cytology. Arch Pathol Lab Med. 2012;136(2):183-189.
7. Wilbur DC, Black-Schaffer WS, Luff RD. The Becton Dickinson FocalPoint GS Imaging System: clinical trials demonstrate significantly improved sensitivity for the detection of important cervical lesions. Am J Clin Pathol. 2009;132(5):767-775.

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As part of our comprehensive plan for Women’s Health testing, CPL will be transitioning Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) testing to the Roche COBAS® 6800/8800 platform. The transition will take place in several phases based on specimen type:

• Phase 1: Urine specimens
• Phase 2: Liquid-based Pap specimens (Thinprep® and Surepath™)
• Phase 3: Swab specimens

The laboratory has validated the Roche platform and determined that:

• The Roche® and Hologic® methods are both FDA-approved nucleic-acid amplification technologies (NAAT).
  • The Roche® method is a qualitative real-time polymerase chain reaction (PCR).
  • The Hologic® method is qualitative target capture and Transcription-Mediated Amplification assay (TMA).
• The Roche® and Hologic® methods are analytically equivalent according to CDC and CPL evaluations.
• The Roche® method confirms as a highly sensitive and specific assay.
• The stability and handling of fresh and transferred urine with both systems are equivalent so client impact is expected to be negligible.

CPL will make every effort to assure that this transition causes no disruption of service. We believe that this transition will improve the pre-analytical and analytical processes by increasing process uniformity and instrumentation redundancy.

Phase 2: PreservCyt(ThinPrep)® and SurePath™ specimens

Effective October 17, 2022, Clinical Pathology Laboratories will be transitioning from the Hologic Aptima® testing platform to the Roche COBAS® 6800 and 8800 for the detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) for PreservCyt (Thinprep)® and SurePath™ specimens. There will be no changes to the collection devices for this phase of the transition. However, the following changes to methodologies are included.

As part of the transition, test names will be edited to NAAT (nucleic acid amplification technology) which includes both polymerase chain reaction (PCR) and transcription mediated amplification (TMA) target amplification technologies. Order codes will remain the same for the tests affected in this phase. The following order codes will be affected by Phase 2 of the transition:

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As part of our comprehensive plan for Women’s Health testing, CPL will be transitioning Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) testing to the Roche COBAS® 6800/8800 platform. The transition will take place in several phases based on specimen type:

• Phase 1: Urine specimens
• Phase 2: Liquid-based Pap specimens (Thinprep® and Surepath™)
• Phase 3: Swab specimens

The laboratory has validated the Roche platform and determined that:

• The Roche® and Hologic® methods are both FDA-approved nucleic-acid amplification technologies (NAAT).
  • The Roche® method is qualitative real-time polymerase chain reaction (PCR).
  • The Hologic® method is qualitative target capture and Transcription-Mediated Amplification assay (TMA).
• The Roche® and Hologic® methods are analytically equivalent according to CDC and CPL evaluations.
• The Roche® method confirms as a highly sensitive and specific assay.
• The stability and handling of fresh and transferred urine with both systems are equivalent so client impact is expected to be negligible.

CPL will make every effort to assure that this transition causes no disruption of service. We believe that this transition will improve the pre-analytical and analytical processes by increasing process uniformity and instrumentation redundancy.

Phase 1: Urine Specimens

Effective September 1, 2022, Clinical Pathology Laboratories will be transitioning from the Hologic Aptima® testing platform to the Roche COBAS® 6800 and 8800 for the detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) for urine specimens. This transition phase will include the following changes to methodologies and collection devices.

Order codes and test names will remain the same for the test affected in this phase. The following order codes will be affected by Phase 1 of the transition:

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As part of our ongoing commitment to improving the diagnosis of kidney disease, CPL is pleased to offer eGFR by creatinine and cystatin C (eGFR-cr-cys). The cystatin C assay is a particle enhanced immunoturbidimetric assay which is FDA-cleared for in vitro quantitative determination of cystatin C in human serum.

In accordance with the NKF-ASN Task Force guidelines, CPL has adopted the 2021 eGFR-creatinine-cystatin C equation for adult patients (age ≥ 18 years). For pediatric patients, NKF hosts a calculator that includes additional biometric information (https://www.kidney.org/professionals/kdoqi/gfr_calculatorped).

Chronic kidney disease (CKD) is a worldwide health problem with significant impact on cardiovascular and overall morbidity and mortality. Glomerular filtration rate (GFR) is critical to provide an accurate diagnosis of CKD as an aid to guide management and predict prognosis. GFR may be directly measured by the clearance of either exogenous or endogenous (e.g., timed creatinine clearance) filtration markers.

For most clinical circumstances, estimating GFR from serum creatinine (eGFR-cr) is appropriate for staging and tracking the progression of CKD. However, the influence of factors including age, muscle mass, diet, and tubular secretion on creatinine may render eGFR-cr inaccurate in some clinical circumstances.

Cystatin C is a low molecular weight cysteine protease inhibitor produced at a constant rate by all nucleated cells, nearly eliminating differences due to muscle mass or gender. Elimination is almost entirely by glomerular filtration, making cystatin C serum concentration inversely correlated with glomerular filtration rate (GFR). Compared with creatinine, several reports have shown that eGFR based on cystatin C is more specific and closely associated with clinical outcomes in CKD. Moreover, the recently published landmark study by the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) demonstrated that new eGFR equations based on both creatinine and cystatin C (eGFR-cr-cys) are more accurate than eGFR equations utilizing creatinine alone.

Based on these findings, the National Kidney Foundation and American Society of Nephrology (NKF-ASN) Task Force recommended national efforts to facilitate routine and timely use of cystatin C to confirm eGFR in adults who are at risk for or have CKD.

According to Kidney Disease Improving Global Outcomes (KDIGO) practice guidelines, confirmation by eGFR-creatinine-cystatin C is warranted in specific circumstances when decisions depend on more accurate knowledge of GFR. KDIGO provides guidance to confirm CKD as below.

Test Information

References

1. 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.
2. Inker LA, et al. New creatinine- and cystatin C–based equations to estimate GFR without race. N Engl J Med. 2021 Sep 23.
3. KDIGO 2012 clinical practice guideline for the evaluation and management of chronic kidney disease. Kidney Int Suppl. 2013; 3: 1-150.

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Informed by guidance from the CDC and other public health authorities, Clinical Pathology Laboratories (CPL) is closely monitoring the outbreak caused by monkeypox virus (MPXV). As of July 14, 2022, more than 1000 infections are confirmed in the US, identified in 42 states. Sonic Healthcare USA has been approved by the CDC to offer their FDA-approved, amplified nucleic acid (RT-PCR) molecular test to identify MPXV. Sonic Reference Laboratory (SRL) has completed validation of the CDC MPXV assay. CPL has established test code 7410 to refer Monkeypox RT-PCR testing to SRL.

Monkeypox Background:

• Etiology: Monkeypox virus
  • Two clades: Central African (CAC) & West African (WAC). WAC is less virulent group circulating in the US.
  • Orthopoxvirus genus: includes smallpox and cowpox. MPXV is not related to varicella/chickenpox/shingles.
  • Virus characteristics: Extraordinary resistance to drying, heat, and pH, which leads to environmental persistence. Materials contaminated with MPXV may remain infectious for months to years.
• Incubation: 6-13 days, may be up to 21 days.
• Signs and Symptoms:
  • Systemic symptoms: Fever, headache, lymphadenopathy, respiratory symptoms, and GI symptoms, including diarrhea.
  • Characteristic Rash:
    • May look like pimple or blister.
    • May appear on face, in mouth, on genitals, or on other body parts (for more information, and examples, see https://www.cdc.gov/poxvirus/monkeypox/symptoms.html).
• Spread:
  • Direct contact with the rash, respiratory secretions during prolonged face-to-face contact, intimate contact, fomites, placental transfer, animal handling.
  • Possible for up to several weeks.
• Clinical differential diagnosis: Rash: Chickenpox/shingles, measles, bacterial skin infections, scabies, medication allergies, HSV, and syphilis. Proctitis/urethritis: STIs.
• Complications: Bacterial infection, sepsis, dehydration, diarrhea, encephalitis.

Diagnostic Testing:

Sonic Healthcare uses the CDC-developed Non-smallpox Orthopoxvirus RT-PCR assay. The CDC assay does not differentiate monkeypox virus from such other Orthopoxvirus such as Vaccinia, Cowpox or other animal poxviruses, but in the absence of recent vaccinia vaccination, a positive result is most consistent with monkeypox virus. Results should be used with clinical presentation, epidemiological data, other diagnostic test results, and vaccination and exposure history. Other viral or infectious rashes may need to be considered (e.g. varicella zoster virus, herpes simplex virus); other STIs may be in the differential diagnosis of monkeypox.

• See below for collection instructions.
• Positive specimens will be referred to CDC for monkeypox virus characterization.
• Test results are reported to public health authorities as required.

Diagnostic Criteria and Classification for Monkeypox Cases:

Suspect Case:

• New characteristic rash* OR
• Meets an epidemiologic criterium (see below) with high clinical suspicion for MPX.

Probable Case:

• No suspicion of other recent Orthopoxvirus exposure (e.g. Vaccinia vaccination) AND
• Presence of Orthopoxvirus DNA by polymerase chain reaction of a clinical specimen
• Note: CPL offers the CDC-approved Orthopoxvirus PCR Assay. Positive tests results from Sonic Reference Lab will represent a “probable case.” Positive cases are referred to CDC for confirmatory MPXV testing.

Confirmed Case:

• Demonstration of MPX DNA by PCR testing of a clinical specimen.

Epidemiologic Criteria:

• Within 21 days prior of a characteristic illness onset:
  • Contact with a person having a similar rash or one who received a diagnosis of confirmed or probable monkeypox OR
  • Close physical contact in a social network experiencing MPX disease spread OR
  • Travel outside the US to a country with confirmed cases of or endemic MPX OR
  • Close contact with dead or live animals or pets associated with African reservoir species or animal products derived from reservoir species.

Exclusion Criteria (case is excluded if):

• An alternative diagnosis can fully explain the illness OR
• An individual with symptoms consistent with monkeypox does not develop a rash within 5 days of illness onset OR
• A case where high-quality testing is negative for Orthopoxvirus or MPXV.

The outbreak caused by MPXV is rapidly evolving, and we will continue to monitor the situation and update you as new information becomes available.

Test Information:

References:
1. Case Definitions† for Use in the 2022 Monkeypox Response. Centers for Disease Control and Prevention website.
Accessed June 2022. https://www.cdc.gov/poxvirus/monkeypox/clinicians/case-definition.html

2. U.S. Monkeypox Outbreak 2022: Situation Summary. Centers for Disease Control and Prevention website. Accessed June 2022.

3. Brown K, Leggat PA. Human Monkeypox: Current State of Knowledge and Implications for the Future. Trop Med Infect
Dis. 2016;1(1):8. Published 2016 Dec 20. doi:10.3390/tropicalmed1010008

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Effective 07/18/2022, CPL will adjust the reference range for blood lead to <3.5 ug/dL for children less than 6 years of age and, as a part of this transition, will report blood lead results to a precision of one decimal point. The reference range adjustment is based on communications to the medical community from the US Centers for Disease Control and Prevention (US CDC) as of October 2021. As background to that guidance, CDC notes:

• No safe blood lead level (BLL) in children exists. Even low levels cause harm.
• The updated reference range is based on the 97.5th percentile of blood lead distribution in U.S. children aged 1–5 years from National Health and Nutrition Examination Survey (NHANES) data set (2015–2016 and 2017–2018 survey cycles).
• The updated reference range to <3.5 ug/dL provides additional opportunity to address low-level exposures and public health disparities in lead exposure in children.

CDC recommends that the reduced threshold be used to empower public health and practitioners to determine whether medical or environmental follow-up actions should be initiated, and it should be used to prioritize communities with the greatest need for primary prevention of exposure and adverse impact. Sources of lead exposure in the US continue to be lead-based paint, contaminated soil, and certain municipal water and plumbing systems. Additionally, this may be associated with certain toys, candies imported from other countries, home remedies, jobs and hobbies involving lead-based products or close proximity to airports with exposure to aviation fuel. The CDC provides extensive guidance on exposure reduction (https://www.cdc.gov/nceh/lead/faqs/lead-faqs.htm).

Affected Order Codes:

* Note: Results reported to single decimal place with change to reference ranges (XX.x ug/dL).

References:

https://www.cdc.gov/nceh/lead/advisory/acclpp/actions-blls.htm

https://www.cdc.gov/mmwr/volumes/70/wr/mm7043a4.htm

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Effective August 8, 2022:

Clinical Pathology Laboratories is pleased to announce the implementation of the new Inova Diagnostics NOVA View indirect immunofluorescence (IFA) platform for the detection and titer of anti-nuclear antibodies (ANA) to assist in the diagnosis of systemic autoimmune rheumatic diseases (SARD). The NOVA View system includes an automated IFA microscopy technology to assess patient reactivity to the HEp-2 human epidermoid carcinoma cultured cell line. The platform applies digital image capture with FDA-approved proprietary mathematical algorithms that stores individual pixels of intranuclear light intensity. The system generates preliminary screen result interpretation, a digital estimate of end-point titer and a computer-assisted IFA pattern interpretation. The American College of Rheumatology supports the immunofluorescence antinuclear antibody (ANA) test using Human Epithelial type 2 (HEp-2) substrate, as the gold standard for ANA testing. ACR notes that alternate bead-based or solid phase methods should demonstrate comparable sensitivity to IFA. The NOVA View platform includes changes to initial screen dilution, cellular substrate and reported patterns as given below.

Notes on ANA testing:

• Up to 100-150 autoantigens are present in HEp-2 cell lines while multiplex or solid-phase immunoassays detect only auto-antibodies directed against the limited number (typically 8-10) of antigens incorporated in the assay.
• The individual antibodies directed to nuclear autoantigens may be more or less frequently associated with specific SARDs. Those disease associations are given in Table 1 below.
• Individual specific autoantibodies may be qualitatively or semi-quantitatively identified using multiplex bead-based immunoassays, solid-phase immunoassays, complementary IFA (e.g. Crithidia lucida) or radio-immunoassay methods. CPL offers a variety of ANA panels with reflex or non-reflex nuclear antibodies as given in the test menu at the end of this announcement.
• Specific ANA patterns by IFA may be associated with individual antibodies to specific nuclear autoantigens as given in Table 2 below.
• The International Consensus on ANA Patterns (ICAP; 12th International Workshop 2014) established a framework for consensus on nomenclature and classification of prevalent HEp-2 IFA patterns (See www.anapatterns.org).

Table 1: List of most frequent clinically relevant autoantigen targets and prevalence in autoimmune disease:

Notes: SLE (systemic lupus erythematosus), MCTD (mixed connective tissue disease), PSS (progressive systemic sclerosis), CREST (calcinosis, Raynaud, esophageal dysmotility, sclerodactyly, telangiectasia syndrome), PM (polymyositis), DM (dermatomyositis)

Table 2: Associations of HEp-2 IFA patterns with antibodies to specific nuclear antigens

** Cytoplasmic, non-nuclear fluorescence

Change in Screening Dilution:

• The NOVA View platform is FDA approved for an initial screen dilution of 1:80. ANA detection at 1:40 is prevalent in healthy populations (19.5%) and non-autoimmune mimics of SARDs (26.4%; using the Immuno Concepts Hep-2000 method).¹¹ Screen thresholds at 1:80 reduce the number of false-positive tests, opportunity for misdiagnosis of connective tissue disorders and consumption of resources without substantially decreasing sensitivity (97.3% vs. 96.4% sensitivity).¹¹
• EULAR/ACR classification criteria use ANA positive at >=1:80 an IFA method or equivalent as an obligatory entry criterion for the diagnosis of SLE.

Change in Substrate and Detection System:

• The NOVA View platform uses an optimally fixed HEp-2 cell line. The HEp-2 substrate replaces the prior HEp-2000 cell line which is genetically transfected with multiple copies of the SS-A DNA sequences. Optimal fixation preserves immunoreactivity for SS-A antigen, avoiding the need for transfection with 60-kDa SSA/Ro, which “caused difficulty in reading patterns.”¹²
• The NOVA View reagent employs IgG conjugate rather than polyspecific conjugate in accordance with Clinical Laboratory Standard Institute guidelines to eliminate false-positive results due to nonspecific low titer IgM autoantibodies. These may be common in older healthy adults.

Change in Staining Pattern Reporting:

• The change in substrate eliminates the previously reported SS-A staining pattern.
• Reported patterns will include homogenous, dense fine speckled, centromere, coarse speckled, discrete nuclear dots, nucleolar, nuclear envelope, and cytoplasmic reticular.

References:

1. ACR Position Statement: https://www.rheumatology.org/Portals/0/Files/Methodology%20of%20Testing%20 Antinuclear%20Antibodies%20Position%20Statement.pdf
2. Manoussakis MN, et al. Sjögren's syndrome associated with systemic lupus erythematosus: clinical and laboratory profiles and comparison with primary Sjögren's syndrome. Arthritis Rheum. 2004 Mar;50(3):882-91. 
3. Chen CY, et al. Use of a new fluorescence immunoassay to detect anti-dsDNA antibodies is more correlated with disease activity and complement than the ELISA method in SLE patients. Lupus. 2003;12(4):266-73.
4. Smeenk RJT et al. dsDNA autoantibodies. In Peter JB, Shoenfeld Y, eds. Autoantibodies. Amsterdam: Elsevier Science BV. 1996:227-36.
5. Peng SL et al. Splicesomal snRNPs Autoantibodies. In Peter JB, Shoenfeld Y, eds. Autoantibodies. Amsterdam: Elsevier Science BV. 1996:774-82.
6. Reichlin M et al. SS-A (Ro) autoantibodies. In Peter JB, Shoenfeld Y, eds. Autoantibodies. Amsterdam: Elsevier Science BV. 1996:783-88.
7. Gordon P, et al. Anti-52 kDa Ro, anti-60 kDa Ro, and anti-La antibody profiles in neonatal lupus. J Rheumatol. 2004
   Dec;31(12):2480-7.
8. Vazquez-Abad D et al. Topoisomerase-I (Scl-70) autoantibodies. In Peter JB, Shoenfeld Y, eds. Autoantibodies. Amsterdam: Elsevier Science BV. 1996:830-35.
9. Russo K, et al. Circulating anticentromere CENP-A and CENP-B antibodies in patients with diffuse and limited systemic sclerosis, systemic lupus erythematosus, and rheumatoid arthritis. J Rheumatol. 2000 Jan;27(1):142-8.
10. Maddison PJ. Aminoacyl-tRNA histidyl (Jo-1) synthetase autoantibodies. In Peter JB, Shoenfeld Y, eds. Autoantibodies. Amsterdam: Elsevier Science BV. 1996:31-35.
11. Vasdev V, et al. Assessment of ideal serum dilution for screening of antinuclear antibodies by an indirect immunofluorescence method in diagnosis of autoimmune disorders. Med J Armed Forces India. 2022 Jan;78(1):54-60.
12. Susan S. Copple, et al, Screening for IgG Antinuclear Autoantibodies by HEp-2 Indirect Fluorescent Antibody Assays and the Need for Standardization, American Journal of Clinical Pathology, Volume 137, Issue 5, May 2012, Pages 825–830

**This order code is included in the following order codes: 4521, 3549, 4278, 4296, 2677, 2304, 2306, 391, 3597, and 9190

As of late May 2022, several cases of monkeypox in the United States are confirmed or under investigation by state public health departments or the US Centers for Disease Control and Prevention (CDC).  Monkeypox is a viral illness that occasionally infects humans in Central and West Africa. It is usually spread by contact with African animals or animal products infected with the virus but can sometimes spread from person to person through large respiratory droplets or contact with body fluids or through intimate physical/sexual contact. CDC provides guidance to the medical community to evaluate possible cases of monkeypox: 

At risk patients: 

• Those with recent travel to Central or West African countries or certain parts of Europe where monkeypox has been reported,
• Those in contact with a person with confirmed or suspected monkeypox, or
• Intimate sexual contact with those at risk.

Clinical features: 

• A rash comprising deep-seated, firm, and well-circumscribed vesicles or pustules that umbilicate or progress over time to scabs.
• Presenting symptoms of fever, chills, distinctive rash, or lymphadenopathy.
• Note: The rash may be confused secondary syphilis, herpes, chancroid, and varicella zoster among others.

Testing: 

• CPL does not offer testing for monkeypox, which is a select agent under federal monitoring
  • https://www.selectagents.gov/sat/list.htm
• To arrange testing, providers must:
  • Consult state or county health department.
  • If state/county resources cannot be reached, contact the CDC through the CDC Emergency Operations Center (770-488-7100) as soon as monkeypox is suspected.
  • Send specimens through state health department

For more information, see: https://www.cdc.gov/poxvirus/monkeypox/response/2022/index.html 

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Effective May 02, 2022:

Clinical Pathology Laboratories is pleased to announce the conversion of troponin testing from the current troponin T assay to the enhanced generation 5 cardiac troponin T (Roche, cTnT GEN5) for the comprehensive evaluation of AMI. The new assay is a high-sensitivity cardiac troponin that enables more sensitive and precise detection at low troponin concentrations.  

Troponin T (TnT) is a component of the contractile apparatus of the striated musculature. Although the function of TnT is the same in all striated muscles, the cardiac isoform of TnT originating exclusively from the myocardium (cardiac TnT, molecular weight 39.7 kDa) clearly differs from skeletal muscle TnT. As a result of its high tissue-specificity, cardiac troponin T (cTnT) is a cardio-specific, highly sensitive marker for myocardial damage.

Rapid, precise, and accurate detection of clinical, imaging, electrophysiological, and biomarker findings are the foundation for the diagnosis of acute myocardial infarction (AMI). Although current cardiac-specific assays are effective, they are often limited by decreased sensitivity and impression.

The Universal Definition of Myocardial Infarction (UDMI) recommends as an “optimal precision” the coefficient of variation (CV) at the 99th percentile upper reference limit to be less than 10%. The Roche Generation 5 Cardiac Troponin T meets the UDMI criteria for “guideline acceptable” precision and the International Federation of Clinical Chemistry (IFCC) definition of a high sensitivity assay.  

Important points:

• Units of Measure: Results are currently reported in ug/L. The new troponin 5th generation will be reported in ng/L.    
• Sex-Specific Reference Ranges: < 14 ng/L for females, < 22 ng/L for males, and < 19 ng/L for not specified.
• Critical Value Has Changed: The new critical value for the 5th generation troponin assay will be ≥14 ng/L for Females, ≥ 22 ng/L for Males, and ≥ 19 ng/L for not specified.
• Only Li-Heparin Plasma Specimens: Test is not FDA approved on serum. Serum specimens will be rejected.

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 Effective April 25, 2022: 

Clinical Pathology Laboratories is pleased to announce that Interleukin-6 (IL-6) analysis will now be performed in-house using the Roche Elecsys Immunoassay. The Roche assay is approved for Emergency Use Authorization by the US FDA. 

The Roche Elecsys IL‑6 electrochemiluminescent immunoassay (eCLIA) is an in vitro diagnostic test for the quantitative determination of Interleukin‑6 (IL-6) in human serum. The assay is used to assist in identifying severe inflammatory response in patients with confirmed COVID-19 illness to aid in determining the risk of intubation with mechanical ventilation, in conjunction with clinical findings and the results of other laboratory testing. Additionally, IL-6 assessment may be informative of a systemic inflammatory response to conditions such as infection, sepsis, lupus or rheumatoid arthritis or to evaluate diabetes, stroke, cardiovascular disease, autoimmunity and cancer.

Changes in reporting:

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Effective 4/6/2021, CPL will perform all antibody testing for the Nucleocapsid antigen of SARS-CoV-2 (the causative agent of COVID-19) using the Roche Elecsys Anti-SARS-CoV-2 chemiluminescent immunoassay (unit code 7304). This is a sandwich immunoassay format designed to select for high-affinity total anti-COVID-19 antibody (IgG, IgA and IgM). The IgG-only COVID-19 Nucleocapsid antigen immunoassay will be discontinued (unit code 7301).

The Elecsys SARS-CoV-2 Nucleocapsid total antibody assay is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. As previously, this test should not be used to diagnose acute SARS-CoV-2 infection for which PCR testing is available. The assay can detect seropositivity in 60.2% of patients within the first week after PCR confirmation and sensitivity rises to 99.5% by day 14. Specificity is among the highest of immunoassays at 99.8%, and there is no cross-reactivity with ordinary endemic common-cold coronavirus species (HKU1, NL63, OC43, etc). For testing performed beyond 100 days, the Elecsys total-antibody assay remains persistently positive, whereas the IgG-only antibody assays show decreased sensitivity for prior COVID-19 infection.

Reference: 

Mohanraj D et al. Comparative assessment of SARS-CoV-2 serology in healthcare workers with Abbott Architect, Roche Elecsys and The Binding site ELISA immunoassays. medRxiv 2021.03.19.21253518; doi: https://doi.org/10.1101/2021.03.19.21253518

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Dear Client,

Clinical Pathology Laboratories, Inc. (CPL), is a committed partner in providing effective, appropriate patient care by ensuring that our testing reflects current medical standards and guidelines.

In our review process, we have identified a quality improvement opportunity concerning ordering patterns and specimen requirements for our Unit Code 6089, Urine Culture, Work Up All Organisms. This Unit Code requests urine culture to identify all organisms and perform antibiotic susceptibilities on each significant organism. While we understand that this request may be appropriate for some clinical scenarios and specialties, such as infectious disease or urology practices, we have identified a pattern that suggests some clinics are requesting this Unit Code by default or are routinely using this for evaluation of uncomplicated urinary tract infections. This practice may identify clinically irrelevant organisms and promote the use of clinically inappropriate antibiotic therapy, not conforming to standards of antimicrobial stewardship.

The Microbiology Department at CPL follows guidelines provided by American Society of Microbiology (ASM), Clinical and Laboratory Standards Institute (CLSI), and Infectious Diseases Society of America (IDSA) guidelines for organism identification and susceptibility testing. To promote adherence to these guidelines, CPL will initiate the following steps to ensure that Unit Code 6089, Urine Culture, Work Up All is limited to specimens from the appropriate clinical presentation:

• Unit Code 6089 will be inactivated by June 1, 2022 with a replacement code that will require physician acknowledgment documentation for use.
• After June 1, 2022, requests for service using Unit Code 6089 will be fulfilled with Unit Code 6049, Standard Urine Culture.
• Specimen requirements for the replacement code will include catheterized urine specimens, suprapubic aspirates, cytoscopic specimens, or urine collected from patients with indwelling stents, urinary foreign bodies, clinically infected calculi, complicated UTIs, or post-prostatic massage.  Specimens should be collected and then transferred to a gray-top urine transport tube.

Unit Code 6049, Standard Urine Culture, is appropriate for symptomatic men and women, suspicious for uncomplicated urinary tract infection. The Microbiology department follows CLSI and ASM guidelines to identify urinary pathogens in pure culture or present at a significant level in mixed cultures. Additionally, Group B Streptococcus is identified at any colony count and in any background in women of child bearing age. A final culture result of “normal genital flora” is based on identification of mixtures of Lactobacillus, coagulase negative Staphylococcus or other skin contaminants in the absence of urinary pathogens. For further questions, please contact your account executive. We appreciate your support of Clinical Pathology Laboratories.

Christine Burgess, MD, MPH 
Director, Microbiology

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Date: December 1, 2021

To: CPL Client

From: Compliance Department

Re: Annual Notice to Physicians

Clinical Pathology Laboratories (CPL) is providing annual notification to our clients of the Medicare policies governing the ordering and reimbursement of laboratory tests. CPL is committed to promoting awareness of and adherence to these policies. In accordance with the Office of the Inspector General’s (OIG) Compliance Program Guide for Clinical Laboratories, we are providing the following information about Medicare requirements:

Medicare Medical Necessity Policy

Medicare will only pay for tests that meet the Medicare definition of “medical necessity”. Medicare may deny payment for a test that the physician believes is appropriate, such as a screening test, which does not meet the Medicare definition of medical necessity.

Medicare Laboratory National Coverage Determinations (NCDs) and Local Coverage Determinations (NCDs)

Coverage determination policies define medical conditions through the inclusion of a list of ICD (diagnosis) codes for which these tests are covered or reimbursed by Medicare. HIPAA regulations require ICD codes to be present on each claim filed. These codes must also be documented in the patient’s medical record.

NCDs: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/LabNCDsICD10.html

LCDs: https://www.novitas-solutions.com Novitas Solutions Jurisdiction H

Frequency Limitations for Laboratory Tests

Certain laboratory tests have specific frequency limitation requirements. The limitations may apply to tests from the laboratory NCDs and LCDs.

Medicare Preventive Screening Laboratory Tests

Certain preventive screening laboratory tests are covered services for Medicare beneficiaries. Benefit coverage is specific for each service, diagnosis codes, coverage requirements, and frequency limitations.

https://www.cms.gov/Medicare/Prevention/PrevntionGenInfo/medicare-preventive-services/MPS-QuickReferenceChart-1.html

American Medical Association (AMA) Organ or Disease-Oriented Panels

The AMA panels were developed for coding purposes only and should not be interpreted as clinical parameters. Organ and disease-oriented panels will only be paid by Medicare when all tests within the panel are deemed medically necessary by Medicare.

https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c16.pdf

Section 90.2 – Organ or Disease-Oriented Panels

Reflex Testing

Reflex testing occurs when initial test results indicate that a second related test is medically appropriate or required by state, regulatory, or accreditation standards. Most tests can be ordered without a reflex. Find details at https://www.cpllabs.com/test-directory

Advance Beneficiary Notice of Non-Coverage (ABN)

• Limited Coverage – An ABN is required if the diagnosis is not covered

• Frequency Limit - An ABN is required at each encounter for frequency limited tests

• Non-Coverage – An ABN is required for experimental or research use tests or tests designated by Medicare as non-covered

https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs.html

Manual 100-04 Medicare Claims Processing Manual

Chapter 30 Financial Liability Protections

Section 50 Form CMS-R-131 Advance Beneficiary Notice of Non-Coverage (ABN)

2021 Medicare Clinical Laboratory Fee Schedule (CLFS)

Current and previous fee schedules are found at:

https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Clinical-Laboratory-Fee-Schedule-Files.html

Additional details can be found at PAMA regulations.

https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/PAMA-Regulations.html

Medicare Part B National Correct Coding Initiative (NCCI) Edits

The Medicare NCCI was implemented to promote national correct coding methodologies and to control improper coding leading to inappropriate payment.

https://www.cms.gov/Medicare/Coding/NationalCorrectCodInitEd/index.html

CMS Signature Requirements

According to CMS' guidance on laboratory services documentation requirements, unsigned requisitions alone do not support physician intent to order. Physicians should sign all orders for diagnostic services to avoid potential denials.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/LabServices-ICN909221-Text-Only.pdf

Contact Information

The Medical Directors and other pathologists are available to discuss appropriate testing and test ordering. Please call (512) 339-1275 or (800) 595-1275 for assistance.

You may also contact our Compliance Department at compliancedept@cpllabs.com.

Please review this notice with all appropriate staff.

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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 Clinical Pathology Laboratories: 

• All high-throughput SARS-CoV-2 molecular assays performed at Clinical Pathology 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.

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As of August 2021 more than 37 million Americans have been infected with COVID-19. A significant number of these patients either continue to experience clinical symptoms or develop new symptoms 4 weeks and later after a COVID-19 infection, including patients with initial mild or asymptomatic infections. Post-COVID conditions present with a wide range of physical and mental health consequences and may be referred to as long COVID, post-acute COVID-19, or chronic COVID, among other names.

The most commonly reported symptoms include:

A recent study conducted by the CDC reported patients experiencing ongoing or "long-haul" symptoms after COVID-19 illness were more likely to report pain, challenges with physical activities, and "substantially worse health" compared with people needing rehabilitation because of cancer1.

It should be noted that currently there is no clearly delineated consensus case-definition for long COVID. The criteria adopted are based on literature and case-reports, so estimates of the scope of the problem among different studies vary. However, based on conservative estimates it is likely that millions of patients may experience post-acute sequela of COVID, which will require proper evaluation and management2. Because of test constraints early in the pandemic, some COVID patients do not have molecular, antigen or serologic confirmation of infection. As a consequence, prior positive COVID test results are not absolutely required to establish a conclusion of long COVID.

Post-COVID conditions may include cardiovascular, pulmonary, renal, dermatologic, rheumatologic, endocrine, neurologic, hematologic, urologic, or psychiatric manifestations or signs. Patients with ongoing or new symptoms might be considered for basic panels of laboratory tests (including testing for non-COVID conditions that may be contributing to illness) to assess for conditions that may respond to treatment, until more information and evidence is available for specific laboratory tests for post-COVID conditions. However, it should be noted that according to current CDC interim guidance there is no laboratory test that can definitively distinguish post-COVID conditions from other etiologies, in part due to the heterogeneity of post-COVID conditions. Before ordering laboratory tests for post-COVID conditions, the goals of these tests should be clear to the healthcare professional and to the patient. Laboratory testing should be guided by patient history, physical examination, and clinical findings.

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Key Points

No laboratory test can definitively distinguish post-COVID conditions from other etiologies

Consider testing symptomatic patients with a basic panel of laboratory tests to assess for treatable conditions

COVID PCR, Antigen, or Antibody laboratory tests are not required to establish a diagnosis of post-COVID conditions but can help assess for current or previous COVID-19 infection

Consider the possibility of SARS-CoV-2 reinfection, especially in persons with new or worsening post-COVID conditions

References:

1Rogers-Brown JS, Wanga V, Okoro C, et al. Outcomes Among Patients Referred to Outpatient Rehabilitation Clinics After COVID-19 diagnosis — United States, January 2020–March 2021. MMWR Morb Mortal Wkly Rep 2021;70. DOI: http://dx.doi.org/10.15585/mmwr.mm7027a2

2Nalbandian, A., Sehgal, K., Gupta, A. et al. Post-acute COVID-19 syndrome. Nat Med 27, 601–615 (2021). https://doi.org/10.1038/s41591-021-01283-z

https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/post-covid-index.html

https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/post-covid-conditions.html

https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/post-covid-assessment-testing.html

In response to recommendations from the National Kidney Foundation and American Society of Nephrology (NKF-ASN) Task Force on estimated glomerular filtration rate (eGFR), effective 12/13/2021, CPL 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. 

The Task Force (TF) was established in 7/2020 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 associated with lower rates of nephrology referral, dialysis options and transplantation for Black vs. non-Blacks. The NKF-ASN TF committed to a GFR estimate approach that recognized the ambiguity of racial distinction and the substantial diversity in the US and one that promoted equity without creating new or worsening preexisting disparities.    

As a part of the TF, the CKD Epidemiology Collaboration conducted a meta-analysis of 10 previously published studies and validated a new single equation for eGFR based on creatinine in a dataset of 12 studies. This new equation is the CKD-EPI Creatinine Refit Equation (CKD-EPIcr_R). The equation balances performance equally between Black and non-Black study participants. 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).

 The TF notes that measured GFR (usually creatinine clearance) may have a certain degree of inaccuracy (incomplete collection, medications, etc) and recommends that clinical decision-making be based on trends in eGFR values.  Assessment for albuminuria, as recommended in the Kidney Disease Improving Global Outcomes (KDIGO) guidelines should be considered essential to assessment of kidney disease. 

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).  

Note: Effective 02/21/2021, the creatinine method will be updated to the enzymatic method, recommended by NKF guidelines to improve precision and accuracy, particularly at medical decision points. Reference intervals are not affected. Referred and local STAT testing may retain the Jaffee method.

Please contact your Account Representative should you have any questions regarding the changes described above. 

Affected Tests and Order Codes: 

Additional references are given below: 

• 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.

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Effective November 22, 2021, Clinical Pathology Laboratories (CPL) will discontinue reference intervals and flagging for the relative percentage WBC differentials for unit codes 1000, 1001, 1007, 1013, 1015, and 1365. This is the final planned CBC reporting update. 

Under most circumstances, clinically relevant WBC elevations and decreases are defined by absolute counts rather than relative percentages. Current recommendations from the College of American Pathologists (CAP) and the Clinical and Laboratory Standards Institute (CLSI), recommend that absolute counts of the WBC differential be reported and used for patient management.   

Important notes:

• Current state-of-the-art CBC instrumentation assesses many 1000’s of WBC’s in automated differentials to provide higher accuracy and precision with shorter turn-around-time for the significant majority of samples.
• The analyzer algorithms interpret signals from WBC, RBC and platelet channels to alert laboratory scientists of an abnormal pathological specimen for manual assessment of smear morphology.
• On smear review, the laboratory has specific criteria to replace automated WBC differential with manual differential and morphology.
• In the event of a manual differential, the laboratory will also provide the more precise automated absolute WBC differential count for clinical use.
• After slide review, the technologist will note if criteria are met for pathologist slide review.

Please contact your Account Representative should you have any questions regarding the changes described above. 

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The U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), launched a new COVID-19 Uninsured Program Portal, allowing health care providers who have conducted COVID-19 testing or provided treatment for uninsured COVID-19 individuals on or after February 4, 2020 to submit claims for reimbursement.

Clinical Pathology Laboratories (CPL) will file claims to any third party payer. Please include patient demographics and insurance information as applicable. If you have determined that the patient is uninsured, CPL will file the appropriate claim when the following information is received:

• Patient name, date of birth, gender and address.
• Patient Social Security Number and/or Driver’s License Number (and issuing state).

HRSA will cover ALL COVID testing sent to CPL including:

If ordering in Atlas on an uninsured patient, place the order as Insurance Bill.

1. Select COVID-19 HRSA Uninsured Testing and Treatment Fund as the insurance type.
2. Enter patients Driver’s License Number in as the Policy Number.
3. Enter the two-letter state abbreviation as the Group Number.
4. If the patient does not have a Driver’s License, place their Social Security Number as the Policy Number.
5. For patients who confirm that they are uninsured but do not have a Driver’s License and do not want to give their Social Security Number, enter 999999 as the Policy Number.

For testing to be eligible for reimbursement by HRSA, claims submitted must include one of the following Diagnosis Codes:

Please contact your Account Representative should you have any questions.

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Effective August 2, 2021, Clinical Pathology Laboratories is pleased to announce a change in instrumentation/ methodology and reference range for AFP Tumor Marker with transition to the Roche Cobas electrochemiluminescence immunoassay (ECLIA) method. Previously, Serum AFP Tumor testing was performed on the Beckman Coulter DxI by paramagnetic particle chemiluminescent immunoassay.

Alpha fetoprotein, an albumin-like glycoprotein with a molecular weight of 70000 daltons, is formed in the yolk sac, fetal/neonatal and regenerating liver cells, and the fetal gastrointestinal tract. 70-95 % of patients with primary hepatocellular carcinoma have elevated AFP values. Assessment of AFP levels are essential for classifying and following certain germ cell neoplasms.

Validation studies with the prior method show strong correlation with a negative bias of 19% that is accommodated by a reference interval adjustment. With the change in reference interval and method, the laboratory will retain the prior method and will archive tested specimens for 30 days to facilitate reestablishment of a baseline if clinically indicated. Additionally, the following note will be applied to communicate this change:

Note: New methodology is Roche Cobas chemiluminescent immunoassay associated with reference interval change. Specimen is retained in laboratory for 30 days for comparative testing if clinically required. Please contact laboratory to reassess with prior method.

Changes in reporting:

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Effective August 2, 2021, Clinical Pathology Laboratories is pleased to announce a change in instrumentation/ methodology and reference range for Serum Myoglobin with transition to the Roche Cobas electrochemiluminescence immunoassay (ECLIA) method. Previously, Serum Myoglobin testing was performed on the Beckman Coulter DxI by paramagnetic particle chemiluminescent immunoassay.

The determination of myoglobin in serum is an important factor in the diagnosis of acute myocardial infarction (AMI), early reinfarction and successful reperfusion following lysis therapy.

Changes in reporting:

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Clinical Pathology Laboratories, Inc. (CPL) recently underwent a post-payment Medical Review relating to Medicare beneficiaries who had a claim including procedure code G0480 - Drug test definitive. The review resulted in several denied claims due to insufficient documentation of medical necessity. CPL wishes to share some takeaways from the review relating to documentation and medical necessity requirements for definitive urine drug tests (UDTs).

Key takeaways:  

• The clinician’s rationale of the medical necessity for the definitive UDT, including the drugs or drug classes to be tested, must be documented in the patient’s medical record.
• All documentation must be maintained in the patient’s medical record and made available to the Medicare contractor upon request.

What are the documentation requirements for definitive UDTs?  

• The medical record documentation and test order must indicate the medical necessity for performing a definitive UDT.
• All tests must be ordered in writing by the treating provider and all drugs/drug classes to be tested must be indicated in the order.
• The record must show that an inconsistent positive finding was noted on the presumptive testing or that there was no available, commercially or otherwise, presumptive test.
• For symptomatic patients, multiple drug ingestion, or patients with unreliable history: the presumptive findings, definitive drug tests ordered, and reasons for testing must be documented in the patient’s medical record.
• For the diagnosis and treatment for substance abuse or dependence: the patient’s medical record must include an appropriate testing frequency based on the stage of screening, treatment, or recovery; the rationale for the drugs/drug classes ordered; and the results.
• For the treatment for patients on chronic opioid therapy: the documentation should minimally include patient history, physical examination, and previous laboratory findings; current treatment plan; prescribed medication(s); and risk assessment plan. The frequency of testing beyond the baseline presumptive UDT must be substantiated by documentation in the patient’s medical record, including a complete clinical assessment of the individual’s risk potential for abuse and diversion using a validated risk assessment interview or questionnaire and should include the patient’s response to prescribed medications and the side effects of medications.

When are definitive UDTs reasonable and necessary?  

• To identify a specific substance/metabolite inadequately detected by a presumptive UDT;
• To definitively identify specific drugs in a large family of drugs;
• To identify a specific substance/metabolite that is not detected by presumptive UDTs;
• To identify drugs when a definitive concentration of a drug is needed to guide management;
• To identify a negative or confirm a positive presumptive UDT result that is inconsistent with a patient’s self-report, presentation, medical history, or current prescribed pain medication plan;
• To rule out an error as the cause of a presumptive UDT result;
• To identify non-prescribed medication or illicit use for ongoing safe prescribing of controlled substances; and
• To use in differential assessment of medication efficacy, side effects, or drug-drug interactions.

Recommendations:  

• Ensure the documentation in the patient’s medical record supports services billed to the Medicare program.
• Remain current with Medicare requirements and educational information referenced in the various publications available to Medicare providers at the Novitas Solutions, Inc. website at www.novitas-solutions.com.
• Attend Provider Outreach and Education seminars to remain current on Medicare updates.
• For additional general education or information pertaining to Medicare, contact the Provider Outreach and Education Department at Education@novitas-solutions.com.

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Effective July 6, 2021, Clinical Pathology Laboratories (CPL) will discontinue reference intervals for the relative percentage WBC differentials for unit codes 1000, 1001, 1007, 1013, and 1015. Additionally, unit codes 1011, 1014, 1016, 1017 and 1050 will be retired as redundant. See below for recommended replacement unit codes which will provide equivalent or comparable testing to those that are being discontinued. These are the final planned CBC reporting updates.

Under most circumstances, clinically relevant WBC elevations and decreases are defined by absolute counts rather than relative percentages. Current recommendations from the College of American Pathologists (CAP) and the Clinical and Laboratory Standards Institute (CLSI), recommend that absolute counts of the WBC differential be reported and used for patient management.

Important notes:

• Current state-of-the-art CBC instrumentation assesses many 1000’s of WBC’s in automated differentials to provide higher accuracy and precision with shorter turn-around-time for the significant majority of samples.
• The analyzer algorithms interpret signals from WBC, RBC and platelet channels to alert laboratory scientists of an abnormal pathological specimen for manual assessment of smear morphology.
• On smear review, the laboratory has specific criteria to replace automated WBC differential with manual differential and morphology.
• In the event of a manual differential, the laboratory will also provide the precise automated absolute WBC differential count for clinical use.
• After slide review, the technologist will note if criteria are met for pathologist slide review.

Please contact your CPL Account Representative should you have any questions regarding the changes described above.

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Laboratory Services Documentation Requirements | What You Need to Know 

The laboratory industry has experienced an increasing number of reimbursement recoupments by payors who have determined that a test requisition that is not signed by the ordering practitioner is not sufficient to establish the practitioner’s intent to order the testing.  As a valued client of Clinical Pathology Laboratories it is important for us to continue to work together to assure that we have sufficient documentation to support intent to order.  

Most payers are now demanding your office notes or other medical documentation to support claims for testing when the test requisition is not signed. While there is still some uncertainty as to whether a “physician signature” on a test requisition, by itself, will be sufficient to support all claims, it is clear that if we have your signature on test requisition forms, we will likely reduce significantly the number of occasions when we need to subsequently request medical record documentation from you or your staff to support our claims.   

It is important that the following be utilized when ordering laboratory services: 

Payor Documentation Requirements: 

• Signed manual requisition
  • All manual requisitions have a place for the physician’s signature
• Signed Electronic (EHR) order
  • Please include ordering physician e-signature section on the form (In the event that the electronic requisition does not display the ordering clinician’s e-signature, the hard-copy e-requisition accompanying the specimen must be signed.)

In the Event of a Payor Audit: 

• Unsigned physician orders or unsigned requisitions alone do not support physician intent to order.
• Unsigned orders could potentially result in burdensome documentation requests for you and your practice after the fact.
• Attestation statements are unacceptable for unsigned physician orders or requisitions.

To minimize resources required for you and your team after services are ordered, please ensure your laboratory orders include your manual or e-signature on the requisition.  

Thank you again for your partnership, understanding and compliance with these payor mandates.  Please contact your local sales representative directly with any further questions. 

References: CMS: Complying with Laboratory Services Documentation Requirements (December 2020)

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/LabServices-ICN909221-Text-Only.pdf

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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

Due to a nationwide shortage, Clinical Pathology Laboratories (CPL) has been informed that the current 3.2% sodium citrate Vacutainer® collection tube supplied by Becton-Dickinson is currently not available to resupply clients and collection centers. The Greiner Bio-One Vacuette® collection tube has been identified as a clinically identical replacement device, and the laboratory has placed a large order and initiated acceptance studies. We expect to be able to restock and respond to supply requests for collection tubes on 5/14/2021. Until then, the laboratory will make every effort to identify residual collection tubes available in our and our partner inventories, will conserve the residual tubes that we have on hand, will identify alternate tube stocks and may request that elective testing be rescheduled until after supply is reestablished. 

We apologize for the inconvenience that this may cause. Please contact your Account Representative should you have any questions. CPL is in regular communication with Becton-Dickinson and Greiner as they work to stabilize production of collection devices and establish additional manufacturing capability. 

References:
www.cdc.gov/mmwr/preview/mmwrhtml/rr6302a1.htm

www.cdc.gov/std/general/DCL-Diagnostic-Test-Shortage.pdf

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Effective April 19, 2021, Clinical Pathology Laboratories (CPL) will begin reporting absolute WBC counts with age- and gender-stratified reference ranges, in addition to the relative percentage WBC differential for the unit codes listed below. This change will also include reporting absolute immature granulocyte count (IG#) in addition to the relative immature granulocyte percentage (IG%). This is the second of several planned CBC reporting updates.

Under most circumstances, clinically relevant WBC elevations and decreases are defined by absolute counts rather than relative percentages. Current recommendations from the College of American Pathologists (CAP) and the Clinical and Laboratory Standards Institute (CLSI), recommend that absolute counts of the WBC differential be reported and used for patient management.

Important notes:

• Current state-of-the-art CBC instrumentation assesses many 1000’s of WBC’s in automated differentials to provide higher accuracy and precision with shorter turn-around-time for the significant majority of samples.
• The analyzer algorithms interpret signals from WBC, RBC and platelet channels to alert laboratory scientists of an abnormal pathological specimen for manual assessment of smear morphology.
• On smear review, the laboratory has specific criteria to replace automated WBC differential with manual differential and morphology.
• In the event of a manual differential, the laboratory will also provide the precise automated absolute WBC differential count for clinical use.
• After slide review, the technologist will note if criteria are met for pathologist slide review.

Over the course of the year, CPL will make additional changes to CBC reporting to more closely align with widely accepted laboratory standards. These include the following changes (implemented in the order listed):

• Discontinuing reference intervals for the relative WBC differentials as these will be superfluous.
• Retiring unit codes 1011, 1014, 1016, 1017 (these orderable codes currently provide absolute WBC counts for subsets of the WBC differential and will become redundant).

Please contact your CPL Account Representative should you have any questions regarding the changes described above.

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Effective April 5, 2021, the “information blocking” prohibition of the Cures Act disallows healthcare providers, including laboratories, from engaging in any practice that is “likely to interfere with access, exchange or use of electronic health information”. In practice, this requires that electronic health information (EHI) such as laboratory test results should be made available to a patient as soon as they are finalized. Prior to the Cures act requirement, CPL delayed release of most test results to patients for 72 hours to allow providers an opportunity to review the laboratory record in advance of patient interaction. Under the Cures Act, routine/blanket delays are no longer allowed. The few exceptions that permit temporary delay include the “preventing harm exception”. Under this exception, the risk of harm must be:

1. Determined on an individualized basis by a provider with a prior relationship with the patient, and
2. That provider determines that immediate access is reasonably likely to endanger the life or physical safety of the patient or another person.

Under the requirement of the Cures Act, all finalized laboratory results (to include blood testing, microbiology, biopsies, cytology and genetic studies) will be made immediately available to patients who have registered for the laboratory portal or who request the results by other electronic means unless the provider specifically attaches an order to hold results as follows:

The request to hold results will temporarily prevent transmission to the laboratory patient portal. All requests will be routinely reviewed by the laboratory, and the provider will be contacted to determine the minimum hold time required to satisfy the requirements of the exception. The provider should document the reason to hold results in their own medical record. The laboratory is required to audit use of the hold code to monitor utilization and prevent routine/blanket use. Further changes to the use of this hold code or the documentation associated with the code may be required as additional information becomes available.

More information is available at: www.healthit.gov/topic/information-blocking 

Please contact your Account Representative should you have any questions regarding the changes described above.

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Effective April 19, 2021, Clinical Pathology Laboratories (CPL) will change the herpes simplex virus (HSV) testing methodology from culture to transcription mediated amplification (TMA). Test code 6069 will include report fields for HSV typing as that is intrinsic to the method. Test code 6068 will be deleted as redundant.

TMA with the Aptima HSV 1 & 2 Assay on the Hologic Panther System will offer:

• Faster turnaround time
• Improved sensitivity
• Subtype testing on every sample

HSV infection with type 1 (HSV-1) or type 2 (HSV-2) is among the most prevalent sexually transmitted infections in the United States, with a seroprevalence of 58% for HSV-1 and 17% for HSV-2 among people 14 to 49 years old. HSV-1 most often causes oral herpes and HSV-2 most often causes genital herpes, however HSV-1 is increasingly responsible for genital infections.

Following infection, lesions first appear between days 2 and 14 (most often between days 4 and 7). Virus is detectable by either viral culture or nucleic acid amplification test (NAAT) when lesions are present. However, viral culture has lower sensitivity that decreases as the lesions heal and is particularly lower for recurrent lesions. NAAT based assays are 2 to 4-times more sensitive and therefore preferred for diagnosing infection.

Diagnosing infection and determining HSV type can indicate the relative risk of recurrence, transmission risks, and prognosis. Therefore, typing will be performed and reported on all samples. While establishment of the HSV type may be epidemiologically useful for patient counseling, it does not generally affect the choice of treatment. A negative result does not necessarily indicate absence of infection since viral shedding is intermittent. This testing does not detect Varicella Zoster virus (VZV) which may produce similar clinical findings. If VZV is a clinical consideration, separate VZV testing may be performed on the same sample.

This change in methodology may result in a pricing adjustment. Please contact your Account Representative for new pricing information.

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Effective March 15, 2021, Clinical Pathology Laboratories (CPL) will be transitioning to a new urinalysis platform. The Sysmex UN-Series is an integrated urinalysis solution used for the in vitro analysis of human urine.  The series is designed to perform urine sediment testing by utilizing the Siemens CLINITEK Novus Automated Urine Chemistry Analyzer, UF-5000^TM Automated Urine Particle Analyzer, the UD-10TM Automated Urine Particle Digital Imaging Device, and Urinalysis Data Manager (UDM^TM). 

Operational improvements of this system include flow cytometry analysis of both formed and cellular elements to provide an additional screening tool for operators and a STAT/Manual Mode option that reduces the minimum required specimen volume from 7 mL to 4 mL.

Reflex criteria from urine chemistry to sediment analysis will include (additional charges will apply):

• Positive BLOOD
• APPEARANCE is anything except clear
• Positive LEUKOCYTE ESTERASE
• Positive NITRITE
• Positive PROTEIN

Patient final report changes going forward will include:

• NONE SEEN to be reported for hyaline casts and bacteria when no particles are present upon analysis
• Reporting units for crystals and casts to be removed from the report to streamline report interpretation for clinicians

Under most circumstances, clinically relevant crystal reporting in urines is performed through qualitative analysis and reported as such. This modification aligns testing at CPL with widely-accepted clinical industry standards. 

Unit code methodology statements will be updated accordingly in the test catalog to include relevant instrument descriptions.

Please contact your Account Representative should you have any questions regarding the changes described above.

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Date: October 1, 2020

To: CPL Client

From: Compliance Department

Re: Annual Notice to Physicians

Clinical Pathology Laboratories (CPL) is providing annual notification to our clients of the Medicare policies governing the ordering and reimbursement of laboratory tests. CPL is committed to promoting awareness of and adherence to these policies. In accordance with the Office of the Inspector General’s (OIG) Compliance Program Guide for Clinical Laboratories, we are providing the following information about Medicare requirements:

Medicare Medical Necessity Policy

Medicare will only pay for tests that meet the Medicare definition of “medical necessity”. Medicare may deny payment for a test that the physician believes is appropriate, such as a screening test, which does not meet the Medicare definition of medical necessity.

Medicare Laboratory National Coverage Determinations (NCDs) and Local Coverage Determinations (NCDs)

Coverage determination policies define medical conditions through the inclusion of a list of ICD (diagnosis) codes for which these tests are covered or reimbursed by Medicare. HIPAA regulations require ICD codes to be present on each claim filed. These codes must also be documented in the patient’s medical record.

NCDs: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/LabNCDsICD10.html

LCDs: https://www.novitas-solutions.com Novitas Solutions Jurisdiction H

Frequency Limitations for Laboratory Tests

Certain laboratory tests have specific frequency limitation requirements. The limitations may apply to tests from the laboratory NCDs and LCDs.

Medicare Preventive Screening Laboratory Tests

Certain preventive screening laboratory tests are covered services for Medicare beneficiaries. Benefit coverage is specific for each service, diagnosis codes, coverage requirements, and frequency limitations.

https://www.cms.gov/Medicare/Prevention/PrevntionGenInfo/medicare-preventive-services/MPS-QuickReferenceChart-1.html

American Medical Association (AMA) Organ or Disease-Oriented Panels

The AMA panels were developed for coding purposes only and should not be interpreted as clinical parameters. Organ and disease-oriented panels will only be paid by Medicare when all tests within the panel are deemed medically necessary by Medicare.

https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c16.pdf

Section 90.2 – Organ or Disease-Oriented Panels

Reflex Testing

Reflex testing occurs when initial test results indicate that a second related test is medically appropriate or required by state, regulatory, or accreditation standards. Most tests can be ordered without a reflex. Find details at https://www.cpllabs.com/test-directory

Advance Beneficiary Notice of Non-Coverage (ABN)

• Limited Coverage – An ABN is required if the diagnosis is not covered

• Frequency Limit - An ABN is required at each encounter for frequency limited tests

• Non-Coverage – An ABN is required for experimental or research use tests or tests designated by Medicare as non-covered

https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs.html

Manual 100-04 Medicare Claims Processing Manual

Chapter 30 Financial Liability Protections

Section 50 Form CMS-R-131 Advance Beneficiary Notice of Non-Coverage (ABN)

2020 Medicare Clinical Laboratory Fee Schedule (CLFS)

During the period beginning on May 1, 2020 and ending on December 31, 2020, the Medicare programs under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) shall be exempt from reduction under any sequestration order issued before, on, or after the date of enactment of the CARES Act. Sequestration also will be extended through fiscal year 2030.

Current and previous fee schedules are found at:

https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Clinical-Laboratory-Fee-Schedule-Files.html

Additional details can be found at PAMA regulations.

https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/PAMA-Regulations.html

Medicare Part B National Correct Coding Initiative (NCCI) Edits

The Medicare NCCI was implemented to promote national correct coding methodologies and to control improper coding leading to inappropriate payment.

https://www.cms.gov/Medicare/Coding/NationalCorrectCodInitEd/index.html

Contact Information

The Medical Directors and other pathologists are available to discuss appropriate testing and test ordering. Please call (512) 339-1275 or (800) 595-1275 for assistance.

You may also contact our Compliance Department at compliancedept@cpllabs.com.

Please review this notice with all appropriate staff.

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The Advanced Beneficiary Notice of Non-coverage (ABN), Form CMS-R-131 helps Medicare Fee-For-Service (FFS) beneficiaries make informed decisions about items and services Medicare usually covers, but may not. An ABN is issued by providers to Medicare beneficiaries in situations where Medicare payment is expected to be denied.  

Due to COVID-19 concerns, Centers for Medicare & Medicaid Services (CMS) had extended the deadline to use ABN form CMS-R-131, with an expiration date of 03/2020, through the end of 2020. 

However, the renewed ABN, with an expiration date of 06/30/2023, will be mandatory to use starting 1/1/2021. The ABN update includes a revised footer and expiration date, but no other changes to the form have been made. The new ABN should have the following footer:

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0938-0566. The time required to complete this information collection is estimated to average 7 minutes per response, including the time to review instructions, search existing data resources, gather the data needed, and complete and review the information collection. If you have comments concerning the accuracy of the time estimate or suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Baltimore, Maryland 21244-1850.

____________________________________________________________________________________________________________________

Form CMS-R-131 (Exp. 06/30/2023)         Form Approved OMB No. 0938-0566

If your current ABN forms have an expiration date of 03/2020, please discard them and contact your CPL Account Representative for new forms. ABN Forms with a 03/2020 expiration date will be ineligible to use after 1/1/2021.

As always, you may utilize CPL’s Atlas ordering system to generate a pre-populated ABN or visit www.cpllabs.com/clinicians/medicare-medical-necessity to access a quick ABN to verify Medicare Medical Necessity.

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Effective January 4th, 2021, CPL will adjust reference intervals for the complete blood count (CBC). Laboratory reference intervals derive from a number of sources, including: guidance from expert organizations or public health authorities (e.g. Glucose, A1c, Lipids, eGFR), formalized reference range studies (e.g. PTT, PT), verification of manufacturer reference ranges (e.g. tumor markers, growth factors), correlation with reference or specialty laboratories, and evaluation of medical literature among others. With a primary focus on pediatric hematology reference intervals and given the limited availability of pediatric volunteers, CPL assessed the CBC data in pediatric patients filtered for routine health examination without abnormal findings, correlated with aligned initiatives in other Sonic Healthcare USA divisional laboratories (ICD codes Z00.129 and Z00.000; more than 80,000 patient specimens evaluated after filtering), reviewed pediatric hematology literature and assessed reference intervals employed at pediatric hospitals and a national reference laboratory. 

Nearly all components of the CBC are subjected to adjustment of the reference intervals, with the magnitude of adjustment varying for a given age or gender bracket. For neonates up to 1 year of age, reference intervals are traceable to Dallman, PR as given in Lanzkowsky’s Manual of Pediatric Hematology and Oncology (see references); for children 2 years of age and up, reference intervals are derived from the normal ICD code filtered pediatric population as given above.  Affected reports are notified to the provider with the following method note:

NOTE: new reference ranges are given for multiple components of complete blood count effective 1/4/2021. The analytic method is unchanged. Please review patient results and reference intervals carefully. 

The reference interval changes will affect the following unit codes: 

• 1000 - CBC with automated WBC differential with platelets
• 1005 - White blood cell count
• 1007 - CBC with manual differential
• 1010 - Red blood cell count
• 1011 - CBC with absolute neutrophil count
• 1013 - CBC with automated differential and MPV
• 1014 - CBC with absolute WBC differential count
• 1016 - CBC with manual differential and absolute WBC differential count
• 1017 - CBC with absolute WBC differential count and MPV
• 1025 - Hemoglobin
• 1030 - Hematocrit
• 1041 - CBC without differential WBC count with platelets
• 1045 - Platelet count

Areas not affected: CBC method, analytic platform, patient results, critical and alert analytes and thresholds, and CPT coding. 

Please contact your Account Representative for more information about this change.
 

References:

Dallman PR, Siimes MA. Percentile curves for hemoglobin and red cell volume in infancy and childhood. J Pediatr. 1979 Jan;94(1):26-31. doi: 10.1016/s0022-3476(79)80344-3. PMID: 758417.

Dallman PR.  Blood and blood-forming tissues . In: Rudolph AM, ed.  Pediatrics . 16th ed. East Norwalk, Conn: Appleton & Lange; 1977: 1178.

Lanzkowsky, Philip; Lipton, Jeffrey; and Fish, Jonathan D. Lanzkowsky's Manual of Pediatric Hematology and Oncology (6th ed.). San Diego, California: Academic Press. 
https://doi.org/10.1016/C2013-0-23320-1 

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Due to a national backorder of reagent, test code 3880 - Stool Pathogen Panel by PCR will be temporarily suspended. All of our reference laboratories have been contacted and have already discontinued or will be discontinuing the assay until further notice. An update will be provided when testing resumes. 

Alternate tests to consider are: 

Please contact your Account Representative with any questions or concerns.

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With the ongoing COVID-19 pandemic testing consuming numerous resources, the laboratory industry and its technology vendors are experiencing critical shortages of consumables and reagents. The Hologic Yellow Aptima Urine test system for Chlamydia trachomatis (CT), Neisseria gonorrhea (NG) and Trichomonas vaginalis (TV) is in nationwide backorder, and supplies available to CPL are limited and intermittently resupplied. To supplement collection supplies and reagents, CPL has validated the Roche COBAS 6800/8800 method for CT, NG and TV. The details of the analysis are as follows: 

• Roche method is qualitative real-time polymerase chain reaction (PCR)
• Hologic method is target capture and Transcription-Mediated Amplification (TMA)
• The Roche and Hologic methods are both FDA-approved nucleic-acid amplification technologies (NAAT)
• The Roche and Hologic methods are considered as analytically equivalent by CDC
• Fresh urine must be transferred to either the Hologic or Roche tube with fill between the guide marks within 24 hours of void

Given the nature of the test shortage, CPL will substitute Roche PCR for Hologic TMA testing as required to meet appropriate turnaround requirements utilizing the original order codes (unit codes). Affected test codes subject to substitution are given in the chart below:

Additional notes:

• This announcement only applies to urine testing. The SimpleSwab and liquid-based Pap specimens are not affected by this test shortage
• The CT/NG/TV report format is suitable to accept Roche PCR results with comments applied to testing that is redirected as follows:
  • Roche: Note: Testing is performed with Roche COBAS 6800/8800 method using real-time polymerase chain reaction (PCR) method
  • Hologic: Note: Assay methodology is nucleic acid amplification by transcription mediated amplification (TMA) utilizing the Aptima Combo 2 Assay
• With nationwide test shortages, CDC offers guidance on STI testing to ensure appropriate utilization. See URL: www.cdc.gov/std/general/DCL-Diagnostic-Test-Shortage.pdf

We apologize for the inconvenience that this may cause. Please contact your Account Representative should you have any questions. CPL is in regular communication with Hologic as they ramp up production of collection devices and establish additional manufacturing capability.

References:
www.cdc.gov/mmwr/preview/mmwrhtml/rr6302a1.htm 
www.cdc.gov/std/general/DCL-Diagnostic-Test-Shortage.pdf

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Effective October 7, 2020, Clinical Pathology Laboratories (CPL) will offer the Roche cobas® SARS-CoV-2 & Influenza A/B multiplex assay. The Roche assay is the first in the US to be authorized under the FDA’s Emergency Use Authorization process. The assay uses highly sensitive high-throughput real-time RT-PCR technology for simultaneous detection and reporting of SARS-CoV-2 (the causative agent of COVID-19), influenza A, and/or influenza B in upper respiratory specimens. Nucleic acid from one or more of these organisms may be detectable in respiratory specimens during the acute (symptomatic) phase of a viral illness, and testing for SARS-CoV-2 specifically should be offered to individuals suspected of a respiratory viral infection consistent with COVID-19 by a healthcare provider. 

As the US heads into the fall, CPL is pleased to offer simultaneous testing for influenza and COVID-19 associated viruses out of a single collection. In the 2019-2020 flu season, the CDC estimates that 39-56 million Americans contracted flu, and more than 400,000 required hospitalization. The Johns Hopkins Coronavirus Resource Center reports close to 
7 million COVID-19 cases since January 2020 with daily cases recently peaking at approximately 70,000/day in the US.  According to the American Society of Microbiology, coinfection with multiple respiratory viruses is possible. More importantly, both COVID-19 and influenza are spread by virus-laden respiratory droplets; both infect lower and upper respiratory epithelium; and both cause fever, cough, anosmia and other respiratory symptoms. However, these do not share the same anti-viral therapy, availability of vaccine or implications for public health. Distinction between these viruses may be clinically highly important. Further test details are given below.

Please contact your Account Representative should you have any questions.

References:
https://coronavirus.jhu.edu/map.html

https://www.cdc.gov/flu/about/burden/preliminary-in-season-estimates.htm

https://asm.org/Articles/2020/July/COVID-19-and-the-Flu 

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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.

With the ongoing COVID-19 pandemic testing consuming numerous resources, the laboratory industry and its technology vendors are experiencing critical shortages of consumables used across a variety of molecular diagnostic platforms. In particular, the pipette tips used in the automation of numerous robotic fluid transfers are in backlog while manufacturing facilities are brought online to meet CPL’s requirements in Women’s Health nucleic acid-amplification testing (NAAT). In this context CPL, will need to urgently migrate certain HPV testing from polymerase chain reaction (PCR, offered by Roche) performed on DNA to transcription mediated amplification (TMA, offered by Hologic) performed on mRNA. The literature and CPL medical leadership support the conclusion that the two technologies are virtually equivalent from a clinical perspective. 

Given the immediate nature of the supply shortage, CPL will substitute HPV mRNA analysis for HPV DNA analysis as required to meet appropriate turnaround requirements. For short backlogs, specimens will be protected and archived until adequate supplies are available. Affected test codes subject to substitution are given in the chart below:

The HPV DNA report format is suitable to acceptable HPV mRNA results with comments applied to all affected testing as follows:

Note: Testing is performed on Hologic Panther platform (using mRNA TMA method) in place of Roche Cobas platform (using DNA PCR method) due to national supply shortage of test consumables. 

• Results reported under HPV 18 represent a Hologic combination of HPV Genotype 18 and 45 reactivity.
• Results reported under HPV, HR, other genotypes are interpreted as positive if Hologic High-Risk HPV reagent is positive but Genotypes 16 and 18/45 are negative.

Testing methodology is transcription-mediated amplification (TMA) for E6/E7 mRNA transcript using the Hologic Aptima assay. The test detects Genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68. A positive HPV screen result indicates the presence of at least one High-Risk HPV type. HPV 16 and 18/45 are individually assessed and reported. 

A negative result does not rule out the presence of HPV not included in the high risk set, current or future dysplasia, a low level of infection, interfering substances or specimen sampling error. For negative screen results, genotyping is not indicated.

We apologize for the inconvenience that this may cause. Please contact your Account Representative should you have any questions.

References:
https://www.nytimes.com/2020/07/23/health/coronavirus-testing-supply-shortage.html

https://www.beckershospitalreview.com/supply-chain/shortage-of-pipette-tips-is-slowing-us-covid-19-testing-2.html

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Effective July 14, 2020, positive COVID-19 PCR results will no longer be called as alert values.

Due to rapidly increasing numbers of positive COVID PCR test results, notifications of abnormal redundant tests appear to be a disrupting influence on providers and may result in clinicians missing essential alerts for newly diagnosed conditions.

Because of rising test utilization and positivity rates in our communities, outpatient care settings are often busy and therefore follow-up of positive COVID-19 test results are consuming key office personnel. Automated systems notifying providers about abnormal test results in integrated electronic medical record systems or through our Atlas web-based platform offer a potential solution and the resultant acknowledgement will translate into timely actions to address these alerts. Additionally, CPL provides individual-level tracking of COVID-19 results through our InNote product, prompting abnormal test result notifications within the patients’ electronic medical record.

Patients also have the option of retrieving their lab results through our secure, web-based Patient Portal, SonicMyAccess: https://www.cpllabs.com/patients/patient-portals-records-requests/.

The benefits of sending automated patient COVID-19 lab result notifications include:

• Increase Your Standard of Care – Keep in touch with patients more frequently without monopolizing office staff time
• Reduce Inbound Calls – Secure result delivery, decreasing inbound inquiries and increasing office staff productivity
• Improve Patient Satisfaction – Through SonicMyAccess, patients are automatically notified of new test results and have access to relevant Educational Content, resulting in informed patients
• Reduce Communication Expenses – Leverage our Patient Portal to alleviate your staff from manually calling, faxing, emailing or mailing results, freeing up key resources to focus on patient care

We are certain that this change will have a positive impact on your practice and will allow you more time to focus on the overall health of your patients. We thank you for your continued partnership and business as we navigate this pandemic together.

Please contact your Account Representative for more information about this change.

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Effective July 20th, 2020, Clinical Pathology Laboratories (CPL) will discontinue the use of specific Women’s Health-associated unit codes as displayed below. These codes were evaluated and determined to be unnecessary, redundant, or not clinically useful. We have provided recommendations for replacement unit codes which will provide equivalent or comparable testing to those that will be discontinued. This is the first of several steps CPL will take to simplify and streamline ordering in Women’s Health over the next several months.

Please contact your Account Representative should you have any questions regarding these changes.

For interface build information, contact the CPL Database Department at dbclinical@cpllabs.com.

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Dear Valued Clients,

On June 4, 2020, the U.S. Department of Health and Human Services (HHS) published new requirements for patient data collection and reporting for COVID-19 test results. 

The following data are required to be collected by all laboratories performing COVID-19 testing:

• Full Name
• Date of Birth
• Gender
• Race
• Ethnicity
• Address including zip code

In addition, the following questions need to be answered at the time of test ordering:

1. First Test  Yes | No | Unknown
2. Employed in healthcare? Yes | No | Unknown
3. Symptomatic as defined by CDC?  Yes | No | Unknown
   • If yes, then Date of Symptom Onset mm/dd/yy
4. Hospitalized?  Yes | No | Unknown
5. ICU?  Yes | No | Unknown
6. Resident in congregate care setting? (including nursing homes, residential care for people with intellectual and development disabilities, psychiatric treatment facilities, group homes, board and care homes, homeless shelter, foster care or other settings) Yes | No | Unknown
7. Pregnant? Yes | No | Unknown

These new reporting requirements are intended to enhance the ability to monitor disease prevalence and trends by initiating epidemiologic case investigations, and assisting with contact tracing. The new guidance standardizes reporting for public health officials and provides them access to comprehensive and real-time data in their response to COVID-19. 

Clinical Pathology Laboratories (CPL) has modified its paper and electronic COVID-19 test requisitions to comply with these requirements. If you use an EMR to order COVID-19 tests, we will be contacting your office to update the electronic interface to accommodate these requirements. If your EMR has any of these demographics, speak with your Account Representative and/or EMR vendor to ensure that these demographics are being sent. We deeply appreciate your support and cooperation to complete this important effort.

The use of CPL-provided requisitions or patient history forms will expedite collection of data for clients who are unable to provide the data via AOE’s or electronic interfaces. Reporting of these new data elements should begin immediately and we appreciate your assistance in providing this new information with all COVID-19 laboratory orders.

The deadline to comply with these new requirements is August 1, 2020.  

Additional Frequently Asked Questions: 
www.hhs.gov/sites/default/files/laboratory-data-reporting-for-covid-19-testing-faqs.pdf

Complete Report requirement List Available at the link below:
www.hhs.gov/sites/default/files/covid-19-laboratory-data-reporting-guidance.pdf

Printable Version

Coronaviruses (CoVs) are a family of enveloped positive-strand RNA viruses that can infect humans and many different species of birds and mammals, including camels, cattle, cats, and bats. The family of viruses can cause respiratory illness ranging from the common cold to more severe respiratory diseases such as Middle East Respiratory Syndrome and Severe Acute Respiratory Syndrome. The most recently identified severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the causative agent of Coronavirus Disease 2019 (COVID-19). Since its emergence at the end of 2019 in Wuhan City, China, the virus has caused an ongoing global outbreak of COVID-19 and a major global public health emergency. The number of patients infected globally by the SARS-CoV-2 virus are increasing rapidly. As of June 24th, 2020, at least 9.24 million confirmed cases and more than 477,000 deaths in over 210 countries are reported. In the US, 123,000 deaths and at least 2.39 million confirmed and presumptive cases of COVID-19 have been reported.

Characteristics of the COVID-19:

• Transmitted via respiratory droplets similar to influenza virus. 

• Has an incubation period of 2-14 days following exposure with most showing symptoms in 5 days. 

• Manifestations range from mild disease with fever, dry cough, shortness of breath, and pulmonary infiltrates to critical illness with respiratory failure, shock, or multi-organ failure.

Methodologies:

Roche COBAS Real-Time RT-PCR: This assay uses the FDA Emergency Use Authorization (EUA) authorized Roche COBAS 2019 Novel Coronavirus (SARS-CoV-2) Real-Time Reverse Transcriptase (RT)-PCR assay intended for the qualitative detection of nucleic acids from SARS-CoV-2 in clinician-instructed self-collected nasal swab specimens (collected on site), and clinician-collected nasal, nasopharyngeal, and oropharyngeal swab specimens from individuals who meet COVID-19 clinical and/or epidemiological criteria. For more information, see:
Fact Sheet for Healthcare Providers: www.fda.gov/media/136047/download
Fact Sheet for Patients: www.fda.gov/media/136048/download  

Roche COBAS Real-Time RT-PCR with specimen pooling: This assay uses the FDA Emergency Use Authorization (EUA) authorized Roche COBAS 2019 Novel Coronavirus (SARS-CoV-2) Real-Time Reverse Transcriptase (RT)-PCR assay. Negative results should be treated as presumptive and, if inconsistent with clinical signs and symptoms or necessary for patient management, pooled samples should be tested individually. Negative results do not preclude SARS-CoV-2 infection and must not be used as the sole basis for patient management decisions. Negative results must be considered in the context of a patient’s recent exposures, history, presence of clinical signs and symptoms consistent with COVID-19. For more information, see:
Fact Sheet for Healthcare Providers: www.fda.gov/media/136047/download 
Fact Sheet for Patients: www.fda.gov/media/136048/download

Thermo-Fisher Real-Time RT-PCR: This assay uses the FDA Emergency Use Authorization (EUA) authorized Thermo Fisher TaqPath COVID-19 Real-Time Reverse Transcriptase (RT)-PCR Diagnostic intended for the qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens (such as nasopharyngeal, oropharyngeal, nasal, and mid-turbinate swabs, and nasopharyngeal aspirate) and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider. For more information, see:
Fact Sheet for Healthcare Providers: www.fda.gov/media/136111/download   
Fact Sheet for Patients: www.fda.gov/media/136114/download

Transcription-Mediated Amplification (TMA): This assay uses the FDA Emergency Use Authorization (EUA) authorized Hologic Aptima SARS-CoV-2 Transcription Mediated Amplification and Dual Kinetic Assay.  It is a nucleic acid amplification test intended for the qualitative detection of RNA from SARS-CoV-2 isolated and purified from nasopharyngeal (NP), nasal, mid-turbinate and oropharyngeal (OP) swab specimens, nasopharyngeal wash/aspirate or nasal aspirates obtained from individuals meeting COVID-19 clinical and/or epidemiological criteria. intended for the qualitative detection of nucleic acids from SARS-CoV-2 in clinician-instructed self-collected nasal swab specimens (collected on site), and clinician-collected nasal, nasopharyngeal, and oropharyngeal swab specimens from individuals who meet COVID-19 clinical and/or epidemiological criteria. For more information, see:
Fact Sheet for Healthcare Providers: www.fda.gov/media/138095/download
Fact Sheet for Patients: www.fda.gov/media/138098/download

CDC’s clinical criteria for COVID-19 testing is frequently updated as additional information becomes available. The most recent information on COVID-19 can be found at: www.cdc.gov/coronavirus/2019-ncov/downloads/priority-testing-patients.pdf. CDC currently provides guidance for testing in five categories with the most recent information found below:

• Testing individuals with signs or symptoms consistent with COVID-19.
• Testing asymptomatic individuals with recent known or suspected exposure to SARS-CoV-2 to control transmission.
• Testing asymptomatic individuals without known or suspected exposure to SARS-CoV-2 for early identification in special settings.
• Testing to determine resolution of infection (i.e., test-based strategy for Discontinuation of Transmission-based Precautions, HCP Return to Work, and Discontinuation of Home Isolation).
• Public health surveillance for SARS-CoV-2.

Test Information

Specimen Requirements 

Testing

COMPLIANCE STATEMENT: The SARS-CoV-2 test is intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal and oropharyngeal swab samples from patients who meet COVID-19 clinical and/or epidemiological criteria. For lower respiratory tract specimens, the assay is submitted for authorization by FDA under an Emergency Use Authorization (EUA). Testing methodology is nucleic acid amplification technology (NAAT) by real-time RT-PCR or transcription mediated amplification (TMA). The methodology employed is noted in the analysis report. If received as separate collection devices, nasopharyngeal and oropharyngeal specimens are combined for analysis. Additional specimens may be split to a separate accession for analysis and reporting as this test includes a single unit of service.

Test results must be correlated with clinical presentation and evaluated in the context of other laboratory and epidemiologic data. Test performance can be affected because the epidemiology and clinical spectrum of infection caused by SARS-CoV-2 is not fully known. For example, the optimum types of specimens to collect and when during the course of infection these specimens are most likely to contain detectable viral RNA may not be known.

The real-time RT-PCR and TMA tests have not been Food and Drug Administration (FDA) cleared but have been authorized by FDA under an Emergency Use Authorization (EUA). The tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of SARS-CoV-2 under Section 564(b)(1) of the Act, 21 U.S.C. section 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Clinical Pathology Laboratories are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. section 263a, to perform high complexity tests.

COVID-19 Specimen Transport Media and Swabs

Printable Version

CDC PUI Form

Effective June 1st, 2020, Clinical Pathology Laboratories will implement the BioRad BioPlex Multiplex Flow Immunoassay to replace traditional ELISA methodology for the following disease state antibody profiles:

• Antiphospholipid antibody syndrome (APS) or lupus anticoagulant
  • Cardiolipin IgA, IgG and IgM Antibody
  • Beta-2 Glycoprotein 1 IgG and IgM Antibody
• Celiac disease or gluten-sensitive enteropathy

  • Deamidated Gliadin Peptide (DGP) IgA and IgG Antibody

  • Tissue Transglutaminase (tTG) IgA and IgG Antibody

• Vasculitis (Wegener granulomatosis, microscopic polyangiitis, Churg-Strauss, others)
  • Myeloperoxidase (MPO) Antibody
  • Serine Proteinase 3 (PR3) Antibody
• Rheumatoid arthritis
  • Cyclic Citrullinated Peptide (CCP) Antibody

The Multiplex Flow Immunoassay comprises collections of polystyrene bead populations distinguished from one another by fluorescence spectra and covalently bound antigen analyzed in a flow cytometry-like detector. This permits simultaneous analysis of multiple antibodies or biomolecules with higher precision and reproducibility than earlier ELISA technology. Aside from distinct units of measure and different cutoffs, the method offers simplified interpretations of Negative or Positive in addition to the raw index values to replace prior interpretations of Indeterminate, Weak Positive, Strong Positive, etc. All assays show the following stability: room temperature 1 day; refrigeration 1 week; frozen 1 month. Additional notes by disease state are given below:

• Antiphospholipid antibody syndrome (APS):
  • Meets criteria set for test performance in Antiphospholipid Antibody testing as expressed in Eleventh International Congress on antiphospholipid antibodies (Sydney APS Laboratory Testing Criteria).
  • To achieve optimal specificity, antibody cutoff is set at 95-99th percentile of normal controls.
• Celiac disease or gluten-sensitive enteropathy
  • Clinical sensitivity/specificity for celiac disease:
    • tTG IgA: 94.3% sensitive/98.8% specific; DGP IgA: 86.6% sensitive/96.9% specific.
    • tTG IgG 44.6% sensitive/95.7% specific; DGP IgG 84.7% sensitive/96.9% specific.
    • tTG IgA antibodies correlate closely with the activity of disease and are useful for diet monitoring.
    • IgG antibodies are more useful and informative in patients with selective IgA deficiency. Consider reflex testing (IgA reflex to celiac antibodies; unit code 4739).
• Vasculitis (Wegener granulomatosis, microscopic polyangiitis, Churg-Strauss, others)
  • MPO shows 95% overall agreement with a prior ELISA method and 93.3% positive agreement with pANCA pattern on indirect immunofluorescence assay (IFA).
  • PR3 shows 95% agreement with prior ELISA and 95% positive agreement with cANCA pattern on IFA.
• Rheumatoid arthritis
  • CCP antibody: 83.1% sensitive (known RA patients), 97.8% specific.
  • With higher specificity than typically seen with rheumatoid factor (RF) assays, positive CCP antibody results are associated with a higher positive predictive value (PPV) for rheumatoid arthritis.

Assay report details are given below:

Additional Test Information:

Printable Version

Effective May 11, 2020, Clinical Pathology Laboratories (CPL) will offer SARS-CoV-2 total antibody assay using the Roche COBAS Electrochemiluminescence Immunoassay (ECLIA) method. The immunoassay is designed to detect IgG, IgA and IgM antibodies to recombinant nucleocapsid protein of SARS-CoV-2 in serum intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown how long antibodies persist following infection and if the presence of antibodies confers protective immunity. It is important to note that negative results do not rule out acute SARS-CoV-2 infection, particularly in those who have been in recent contact with the virus. Testing with a nucleic acid amplification test (NAAT; RT-PCR, TMA, others) should be considered to evaluate for active infection in these individuals. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.

This test has not been Food and Drug Administration (FDA) cleared or approved but has been authorized by FDA under an Emergency Use Authorization (EUA). This test has been authorized only for the detection of antibodies against SARS-CoV-2, not for any other viruses or pathogens. The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of SARS-CoV-2 under Section 564(d)(1) of the Act, 21 U.S.C. section 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Clinical Pathology Laboratories is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. section 263a, to perform high complexity tests. This assay is not for the screening of donated blood.

Fact Sheet for Healthcare Providers: www.cpllabs.com/COVID19_TotalAntibody_FactSheet_HealthcareProvider

Fact Sheet for Patients: www.cpllabs.com/COVID19_TotalAntibody_FactSheet_Patient

Please contact your Account Representative should you have any questions.

Printable Version

Effective April 28, 2020, Clinical Pathology Laboratories (CPL) will offer IgG serology for SARS-CoV-2, the causative agent of COVID-19 clinical illness. The Abbott Architect chemiluminescent microparticle immunoassay (CMIA) is designed to detect IgG antibodies to the nucleocapsid protein of SARS-CoV-2 in serum from patients who have signs and symptoms of infection, are suspected of coronavirus disease (COVID-19) or have been infected by SARS-CoV-2. It is important to note that negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Testing with a nucleic acid amplification test (NAAT; RT-PCR, TMA, others) should be considered to evaluate for active infection in these individuals. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.

This test has not been Food and Drug Administration (FDA) cleared or approved but has been authorized by FDA under an Emergency Use Authorization (EUA). This test has been authorized only for the detection of IgG antibodies against SARS-CoV-2 and not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of In-Vitro Diagnostic tests for detection and/or diagnosis of SARS-CoV-2 under Section 564(d)(1) of the Act, 21 U.S.C. section 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Clinical Pathology Laboratories is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. section 263a, to perform high complexity tests. This assay is not for the screening of donated blood.

Fact Sheet for Healthcare Providers: www.cpllabs.com/COVID19_IgGAssay_FactSheet_HealthcareProvider

Fact Sheet for Patients: www.cpllabs.com/COVID19_IgGAssay_FactSheet_Patient

Please contact your Account Representative should you have any questions.

Printable Version

Sonic Healthcare USA Announces Testing Availability for COVID-19

Austin, Texas – March 13th, 2020

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.

The information provided below is current as of March 9, 2020.

Under the guidance of the US Centers for Disease Control and Prevention (CDC), Sonic Healthcare USA (SHUSA) laboratories are closely monitoring the Coronavirus 2019 (COVID-19) outbreak caused by SARS-CoV-2. To date, over 100,000 human infections have been confirmed, and almost 4,000 patients have died.

Affected Geographic Areas with Widespread or Sustained Community Transmission:

• China

• Iran

• Italy

• Japan

• South Korea

Imported cases have been identified in the U.S. According to the CDC:

• Some international destinations now have apparent community spread with the virus that causes COVID-19, as do some parts of the United States. Community spread means some people have been infected and it is not known how or where they became exposed.   
• The virus is thought to spread mainly from person-to-person.
  • Between people who are in close contact with one another (within about 6 feet).
  • Through respiratory droplets produced when an infected person coughs or sneezes.
• No vaccine or specific treatment for COVID-19 is currently available. 
• Care is supportive.

Interim Guidance from the CDC for Healthcare Providers:

• Infection control procedures are necessary to prevent infections from spreading during healthcare delivery. COVID-19 Infection Control recommendations provided by the CDC may be accessed at: https://www.cdc.gov/coronavirus/2019-nCoV/hcp/infection-control.html
• For initial diagnostic testing for SARS-CoV-2, CDC recommends collecting and testing upper respiratory tract specimens (nasopharyngeal AND oropharyngeal swabs). 
• In considering whether a patient represents a person under investigation (PUI) for COVID-19, healthcare providers should immediately notify infection control personnel at their healthcare facility and their local or state health department. Use links below:
  • Local health department: https://www.naccho.org/membership/lhd-directory 
  • State health department: https://www.cste.org/page/StateEpi 
  • PUI documentation: https://www.cdc.gov/coronavirus/2019-ncov/downloads/pui-form.pdf 
• Laboratory testing for other pathogens from PUIs (including testing for influenza, RSV, respiratory pathogen panel, etc.) should not be delayed. In order to provide adequate infection control, please notify Clinical Pathology Laboratories in advance of sending specimens from a PUI for COVID-19. A separate specimen(s) will be required.

Criteria to Guide Evaluation of Patients Under Investigation (PUI) for COVID-19

• As the availability of diagnostic testing for COVID-19 increases through clinical laboratories performing molecular diagnostic (nucleic acid-amplification tests) tests authorized by the US FDA under an Emergency Use Authorization (EUA), testing will be offered to a wider group of symptomatic patients. 
• 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. Most patients with confirmed COVID-19 have developed a fever and/or symptoms of acute respiratory illness (e.g., cough, difficulty breathing). Clinicians are strongly encouraged to test for other causes of respiratory illness, including infections such as influenza.
• Epidemiologic factors that may help guide decisions on whether to test include: any persons, including healthcare workers, who have had close contact with a laboratory-confirmed COVID-19 patient within 14 days of symptom onset, or a history of travel from a geographic area with the ongoing transmission (see list above) within 14 days of symptom onset.
• State and local health authorities may assist or guide clinicians in PUI identification, evaluation, and testing.  
• Clinicians will also be able to access laboratory testing through public health laboratories in their jurisdictions.

For additional information, please use links given below:

• Clinical criteria: https://www.cdc.gov/coronavirus/2019-nCoV/clinical-criteria.html
• Evaluation of exposed staff:  https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-risk-assesment-hcp.html 
• Infection control in healthcare settings: https://www.cdc.gov/coronavirus/2019-ncov/infection-control/control-recommendations.html 

The COVID-19 outbreak is rapidly evolving, and we will continue to monitor the situation and update you as new information becomes available.

- Pathologist Executive Leadership Council, Sonic Healthcare USA

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.

Effective March 16, 2020, Clinical Pathology Laboratories (CPL) will update reference ranges for the complete blood cell (CBC) count. This is the first of several planned CBC updates.

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)] using similar Sysmex technology and a large pediatric population. In aggregate the new reference ranges are not expected to significantly shift the percentage of patients flagged as having abnormal values, however clinicians may see a shift of up to 5% in the number of patients with abnormal results for select components such as hemoglobin.

Over the course of the year, CPL will make additional changes to CBC reporting to more closely align with widely accepted laboratory standards. These include the following changes (implemented in the order listed):

• Reporting absolute WBC counts (e.g., absolute neutrophil count, absolute lymphocyte count, etc.) with appropriate reference ranges, in addition to the relative percentage WBC differential for all unit codes. This change will also include reporting absolute immature granulocyte count (IG#) in addition to the relative immature granulocyte percentage (IG%).

Under most circumstances, clinically relevant WBC elevations and declines are defined by absolute counts, not by relative percentages. Current recommendations from 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 differentials as they are superfluous.
• Retiring unit codes 1011, 1014, 1016, 1017 (these orderable codes currently provide absolute WBC counts for subsets of the WBC differential and will become redundant).

As a reminder, with the latest CBC instrumentation, automated WBC differentials are superior to manual WBC differentials in terms of accuracy, precision, turn-around-time, and clinical sensitivity in distinguishing normal from abnormal samples. The instruments have complex flagging systems that alert technologists to abnormal morphology that requires a manual slide review and replacement of the automated differential with a manual differential. After slide review, the technologist will note if criteria are met for pathologist slide review.

Please contact your Account Representative should you have any questions regarding the changes described above.

ORDER UNIT CODES: 1000, 1001, 1005, 1007, 1010, 1011, 1013, 1014, 1015, 1016, 1017, 1025, 1030, 1041, 1045, 1047, 1050, 1051, 1365

Download Full List of CBC Count the Reference Ranges

Effective March 16, 2020, Clinical Pathology Laboratories will implement a new DiaSorin LIAISON® Chemiluminescent immunoassay for Borrelia burgdorferi (Lyme Disease) to replace the Immunetics ELISA method. The LIAISON® assay format includes the entire VIsE (the variable major protein-like sequence surface protein) antigen complex in a reagent format that provides greater specificity for Lyme Disease. The prior assay utilized the C6 antigen, a portion of the VIsE antigen. In laboratory validation studies, manufacturer instruction for use and literature review, the Diasorin LIAISON® assay shows lower false positive rate and decrease in overall positivity rates relative to prior methods.

Background information: 

• The LIAISON® assay provides presumptive qualitative detection of IgG and IgM antibodies to VlsE protein antigen of Borrelia burgdorferi in human serum.
• This assay should be used only on samples from patients with signs and symptoms that are consistent with Lyme disease.
• Positive or equivocal results should be supplemented by testing with Immunoblot confirmatory testing.
• Positive Immunoblot confirmatory testing provides evidence of exposure to Borrelia burgdorferi and can be used to support a clinical diagnosis of Lyme disease.
• Negative results by LIAISON® Borrelia burgdorferi assay do not completely exclude Lyme disease as early stages of infection or treatment for Lyme disease may be associated with low or undetectable antibody levels. If clinical suspicion remains high, repeat serologies or other testing should be considered.

Additional Test Information:

Please contact your Account Representative should you have any questions.

Printable Version

Effective 3/02/2020, CPL will adopt the Martin-Hopkins method for calculated low-density lipoprotein cholesterol (calc. LDL-C). The method replaces the traditional Friedewald formula, which employed a ratio of 5 for triglyceride: very low-density lipoprotein (TRIG/VLDL) in order to compute LDL from total cholesterol, HDL cholesterol and triglycerides according to the following formula:

Calc. LDL-C = CHOL. – (HDL-C) – (TRIG/5)

While Friedewald has been the mainstay in LDL-C estimation for more than 40 years, it has been recognized that the equation tends to underestimate directly measured LDL-C when TRIG is significantly elevated. In an evaluation of more than 1 million patients from the Very Large Database of Lipids (VLDL dataset), Martin and colleagues validated a novel equation which replaced the fixed ratio of 5 for VLDL-C with a factor that varied from approximately 3 to 12 based on a patient's individual non-HDL-C and TRIG values.

Calc. LDL-C = CHOL. – (HDL-C) – (TRIG/NOVEL FACTOR)

With implementation of the novel factor, Martin-Hopkins shows higher accuracy as triglycerides trend higher and non-HDL cholesterol and LDL-C trend lower. Improved accuracy for lower values of estimated LDL is increasingly important in the 2018 American Heart Association/American College of Cardiology (AHA/ACC) guidance which recommends that many patients be managed at an LDL threshold of 70 mg/dL. The net effect of the transition to Martin-Hopkins will be overall increased calculated LDL-C for patients who have elevated Triglycerides (150-400 mg/dL) and low non-HDL cholesterol. Of note, the reference intervals and guidance from expert groups are not changed. See image below.

As previously noted, the new estimate will not be performed for elevated triglycerides that exceed 400 mg/dL. In this case, directly measured LDL (test code 4228) is recommended. Please contact your CPL Account Representative for more details. 

REFERENCES:
Martin SS, Blaha MJ, Elshazly MB, et al. Comparison of a Novel Method vs the Friedewald Equation for Estimating Low-Density Lipoprotein Cholesterol Levels From the Standard Lipid Profile. Jama. 2013;310(19):2061. doi:10.1001/jama.2013.280532.

Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA / ACC / AACVPR / AAPA / ABC / ACPM / ADA / AGS / APhA / ASPC / NLA / PCNA Guideline on the Management of Blood Cholesterol A Report of the American College of Cardiology / American Heart Association Task Force on Clinical Practice Guidelines WRIT.; 2018. doi:10.1161/CIR.0000000000000625.

Printable Version

The information provided below is current as of February 27, 2020.

Under the guidance of the US Centers for Disease Control and Prevention (CDC), Sonic Healthcare USA (SHUSA) laboratories are closely monitoring the Coronavirus 2019 (COVID-19) outbreak caused by SARS-CoV-2 (previously known as 2019-nCoV). To date, over 80,000 human infections have been confirmed.  More than 2500 patients have died.

Affected Geographic Areas with Widespread or Sustained Community Transmission:

• China
• Iran
• Italy
• Japan
• South Korea
   

Imported cases have been identified in seven states in the US: Washington, California, Arizona Texas, Wisconsin, Massachusetts, and Illinois.
 

According to the CDC:

• At least one person-to-person transmission in the U.S. has been reported.
• No vaccine or specific treatment for COVID-19 is currently available.
• Care is supportive.
   

Interim Guidance from the CDC for Healthcare Providers:

• Infection control procedures are necessary to prevent infections from spreading during healthcare delivery. COVID-19 Infection Control recommendations provided by the CDC may be accessed at: https://www.cdc.gov/coronavirus/2019-nCoV/hcp/infection-control.html
• For patients being evaluated with fever and acute respiratory illness, a detailed travel history is essential. The Criteria to Guide Evaluation of Patients Under Investigation (PUI) for COVID-19 are provided in the chart below. This information may also be accessed at: https://www.cdc.gov/coronavirus/2019-nCoV/hcp/clinical-criteria.html
• In the event of a PUI for COVID-19, healthcare providers should immediately notify both infection control personnel at their healthcare facility and their local or state health department.
• In coordination with local or state health departments, the CDC’s Emergency Operations Center (770-488-7100) will assist local/state health departments to collect, store, and ship specimens appropriately to CDC, including during after hours or on weekends/holidays.
• While COVID-19 testing can currently only be conducted at the CDC, laboratory testing for other pathogens from PUIs (including testing for influenza, RSV, etc.) should not be delayed. In order to provide adequate infection control, please notify Clinical Pathology Laboratories in advance of sending specimens from patients under investigation for COVID-19.
   

Criteria to Guide Evaluation of Patients Under Investigation (PUI) for COVID-19

For additional information, please visit https://www.cdc.gov/coronavirus/2019-nCoV/clinical-criteria.html

The outbreak caused by COVID-19 is rapidly evolving, and we will continue to monitor the situation and update you as new information becomes available.

Effective February 10, 2020, Clinical Pathology Laboratories will implement the Roche COBAS c502 immunoturbidometric assay for Beta-2-Microglobulin (B2M) to replace the Siemens Immulite 2000 method. In validation studies and literature review, the new assay demonstrates up to a 20% positive bias relative to the prior assay. As a result and in accordance with the package insert, CPL will:

• Adjust reference intervals to those given in the chart below:

• We will retain B2M specimens for 30 days from implementation until March 10th and offer to reestablish baselines until April 10th 2020 at clinician request. Tested specimens will be archived frozen, and will be available to compare Roche Cobas results to the prior method (Siemens Immulite) at no additional charge. After March 10th 2020, specimens will be retained refrigerated for 7 days.

Additional Test Information:

Please contact your Account Representative should you have any questions regarding re-baselining and testing details.

Printable Version

Date: August 1, 2019

To: CPL Client

From: Compliance Department

Re: Annual Notice to Physicians

Clinical Pathology Laboratories (CPL) is providing annual notification to our clients of the Medicare policies governing the ordering and reimbursement of laboratory tests. CPL is committed to promoting awareness of and adherence to these policies. In accordance with the Office of the Inspector General’s (OIG) Compliance Program Guide for Clinical Laboratories, we are providing the following information about Medicare requirements:

Medicare Medical Necessity Policy

Medicare will only pay for tests that meet the Medicare definition of “medical necessity”. Medicare may deny payment for a test that the physician believes is appropriate, such as a screening test, but which does not meet the Medicare definition of medical necessity.

Medicare Laboratory National Coverage Determinations (NCDs) and Local Coverage Determinations (NCDs)

Coverage determination policies define medical conditions through the inclusion of a list of ICD (diagnosis) codes for which these tests are covered or reimbursed by Medicare. HIPAA regulations require ICD codes to be present on each claim filed. These codes must also be documented in the patient’s medical record.

NCDs: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/LabNCDsICD10.html

LCDs: https://www.novitas-solutions.com Novitas Solutions Jurisdiction H

Frequency Limitations for Laboratory Tests

Certain laboratory tests have specific frequency limitation requirements. The limitations may apply to tests from the laboratory NCDs and LCDs.

Medicare Preventive Screening Laboratory Tests

Certain preventive screening laboratory tests are covered services for Medicare beneficiaries. Benefit coverage is specific for each service, diagnosis codes, coverage requirements, and frequency limitations.

https://www.cms.gov/Medicare/Prevention/PrevntionGenInfo/medicare-preventive-services/MPS-QuickReferenceChart-1.html

American Medical Association (AMA) Organ or Disease-Oriented Panels

The AMA panels were developed for coding purposes only and should not be interpreted as clinical parameters. Organ and disease-oriented panels will only be paid by Medicare when all tests within the panel are deemed medically necessary by Medicare.

https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c16.pdf

Section 90.2 – Organ or Disease-Oriented Panels

Reflex Testing

Reflex testing occurs when initial test results indicate that a second related test is medically appropriate or required by state, regulatory, or accreditation standards. Most tests can be ordered without a reflex. Find details at https://www.cpllabs.com/test-directory

Advance Beneficiary Notice of Non-Coverage (ABN)

• Limited Coverage – An ABN is required if the diagnosis is not covered

• Frequency Limit - An ABN is required at each encounter for frequency limited tests

• Non-Coverage – An ABN is required for experimental or research use tests or tests designated by Medicare as non-covered

https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs.html

Manual 100-04 Medicare Claims Processing Manual

Chapter 30 Financial Liability Protections

Section 50 Form CMS-R-131 Advance Beneficiary Notice of Non-Coverage (ABN)

2019 Medicare Clinical Laboratory Fee Schedule (CLFS)

Effective January 1, 2019, CLFS rates are based on weighted median private payor rates as required by the Protecting Access to Medicare Act (PAMA) of 2014. Current and previous fee schedules can be found at:

https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Clinical-Laboratory-Fee-Schedule-Files.html

Additional details can be found at PAMA regulations.

https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/PAMA-Regulations.html

Medicare Part B National Correct Coding Initiative (NCCI) Edits

The Medicare NCCI was implemented to promote national correct coding methodologies and to control improper coding leading to inappropriate payment.

https://www.cms.gov/Medicare/Coding/NationalCorrectCodInitEd/index.html

Contact Information

The Medical Directors and other pathologists are available to discuss appropriate testing and test ordering. Please call (512) 339-1275 or (800) 595-1275 for assistance.

You may also contact our Compliance Department at compliancedept@cpllabs.com.

Please review this notice with all appropriate staff.

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Effective November 11, 2019, Clinical Pathology Laboratories (CPL) will convert the current test system for Hepatitis, HIV, and Tacrolimus from the Abbott Architect to the Roche Cobas e801 and e602 platforms utilizing an electrochemiluminescent immunoassay (ECLIA) methodology. The assays and unit codes listed below will be moving. There will be no changes to unit codes associated with this conversion.

As a result of this conversion, the following changes to reporting will be occurring:

• Clinical Pathology Laboratories will no longer be reporting Hepatitis C Index Values, as index values are no longer recommended by the CDC in the determination of follow-up testing. Per the updated CDC guidelines, HCV RNA is the recommended confirmatory test for HCV. For more information visit the CDC website at http://www.cdc.gov/hepatitis/hcv/guidelinesc.htm
• Clients may see a fewer “Equivocal” results due to increased specificity on the Roche Cobas e801/e602 platform and the absence of “Equivocal” as a reportable result for some analytes.
  • The following analytes will see fewer Equivocals due to increased sensitivity of the Roche Cobas:
    • Hepatitis A IgM
    • Hepatitis B surface Antibody
    • Hepatitis B surface Antigen
  • The following analytes will no longer report any results as “Equivocal”:
    • Hepatitis B core IgM
    • Hepatitis B core Total
    • Hepatitis C

Please contact your CPL Account Representative should you have any questions regarding this change.

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Effective 10/14/2019, a new formulation of Sex Hormone Binding Globulin (SHBG) reagent is implemented by the test manufacturer to correct long-term drift in assay recovery. Validation studies of the new SHBG formulation shows recovery 18% lower than the prior assay. The shift tends to increase the calculated free and bioavailable testosterone an average of 12% for adult males and 16% for adult females. The manufacturer does not provide guidance to adjust reference intervals for SHBG. Additionally, there is no specific recommendation to alter the calculated free or bioavailable testosterone reference ranges. The free and bioavailable testosterone are calculated from total testosterone and adjusted for SHBG and albumin binding according to Vermeulen¹, and the reference ranges represent a collaboration with Sonic Reference Laboratory (SRL) who offer LC-MS based measurement of total testosterone, suitable for women and children. The following graph shows the shift in free testosterone as a function of SHBG (prior assay) and total testosterone when calculated using the method of Vermeulen:

CPL is assessing free and bioavailable testosterone in the patient population to determine suitability of established reference ranges.

1: “A Critical Evaluation of Simple Methods for the Estimation of Free Testosterone in Serum”, Vermeulen, A, Verdonck, L., Kaufman, J.M., Journal of Clinical Endocrinology & Metabolism, 84:10, October 1999, 3666-3672.  

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Effective 10/28/2019, Clinical Pathology Laboratories (CPL) will no longer accept the blue Hologic Unisex Swab Collection Kit for rectal or pharyngeal samples. From this date forward, the orange Hologic Multitest Swab Collection Kit (also known as “SimpleSwab”) will be the only acceptable collection device for the following C. trachomatis (CT) and/or N. gonorrhoeae (NG) tests:

DISCONTINUED:	RECOMMENDED:

Between now and 10/28/2019, submission of specimens using either of these collection kits will be accepted, but please be aware that specimens collected after 10/28/2019 should only be submitted using the orange Multitest Collection Kit Swabs. The blue Unisex Swabs are still required for endocervical and male urethral samples, particularly as the device includes a female cleaning swab.

Please contact your Account Representative or your local CPL supply department to to obtain the orange Multitest swabs as needed for the changes described above. 

NOTE: This change is being made as a result of recent FDA clearance of the Multitest Swab Collection Kit for this testing which was formerly performed on the Unisex Swab based on validations conducted by CPL.

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CPL requests that all cytology and histology specimen containers be labeled with two patient identifiers at the time of collection. In clinical practice, patient safety protocols require a minimum of 2 patient identifiers to be used to definitively identify and match patient information. This practice is required for all primary specimen containers and submitted slides.

Specimen containers should be labeled with:

• Full patient name (both first and last name)
• A second identifier such as Date of Birth (DOB), hospital or clinic number, patient ID number, accession number, requisition number, or any other unique number for the patient
• Source of specimen must be noted on the specimen container and/or submitted slides

Slides and/or smears submitted with patient material affixed should be labeled in pencil with:

• Patient full name
• Specimen source or site
• If preparing both fixed and unfixed (air-dried) slides, mark the slides accordingly with clear indication of the air-dried (unfixed) slides

The primary specimen container is the innermost container received by the laboratory that actually holds the specimen, such as a tissue vial or slide.

• Patient’s correctly spelled first and last name
• Patient’s date of birth
• Patient ID number, if applicable
• Hospital, clinic or accession number, if applicable
• Account name, address, phone, and account number
• Requesting physician’s name
• Source of specimen corresponding to specimen container
• Note: If multiple tissue specimens are collected on the on same patient – ensure the specimens are listed on the requisition in order and the containers correlate with the requisition (A, B, C). A source should be listed for each specimen.
• Patient clinical history 

Proper sample identification is critical to specimen integrity from the time of collection, to laboratory processing, testing and result reporting. 

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Opiate and prescription medication abuse constitutes a continuing public health crisis in the United States. According to recent estimates by the CDC, more than 90 Americans die each day from opiate overdose,¹ and current estimates place the total economic burden of prescription opiate medication misuse alone at $78.5 billion a year.² To monitor patient compliance with prescribed medications and to identify recent use of non-prescribed medications or illicit substances, Clinical Pathology Laboratories (CPL) in partnership with Sonic Reference Laboratory (SRL), A Sonic Healthcare Company, will begin to offer in-house Drug Monitoring Profiles designed for patients who have been prescribed pain management or other controlled substance prescription medications starting on July, 15 2019. 

CPL and SRL’s Drug Monitoring program includes testing for 30 different classes of drugs with screening performed by liquid chromatography-tandem mass spectrometry (LC-MS/MS) or immunometric techniques and with reflex or directly ordered confirmation performed by high-resolution LC-MS/MS. Individual classes range from one to many individual tests (see attached Drug Monitoring Attachment). In addition to individual classes, providers may choose profiles as appropriate to meet the needs of their patient compliance monitoring: 

Further notes about this service:

1. Natural cannabinoids, nicotine, and non-opioid analgesics (e.g. acetaminophen) can be ordered separately with any one of the panels above. These medications may be outside of the specifications of many monitoring programs. 

2. Short acting sedatives (Zolpidem, Zaleplon, Zopiclone) can be ordered separately with any one of the panels above. These are best assessed with use of a frozen specimen as they have decreased refrigerated stability. 

3. For medication review in context of test results, please submit a list of prescribed medications. The Drug Monitoring Attachment can be used to document medications in addition to requesting specific Drug Monitoring Profiles or classes to be tested. 

4. All specimens are also subjected to validity testing to assess for adulteration. Please review report notes carefully. 

5. An enhanced report is available summarizing the medication list, all positive results and salient negative results (inconsistent negative – if a medication list is provided) at the top of the report with the results a complete analysis in the body of the report. Where possible, the enhanced report will include historical results. This report can be provided under separate cover. Please review this with your CPL Account Representative. 

 REFERENCES 

1. Rudd RA, Seth P, David F, Scholl L. Increases in Drug and Opioid-Involved Overdose Deaths — United States, 2010–2015. MMWR Morb Mortal WklyRep. 2016;65. doi:10.15585/mmwr.mm655051e1. 
2. Florence CS, Zhou C, Luo F, Xu L. The Economic Burden of Prescription Opioid Overdose, Abuse, and Dependence in the United States, 2013. MedCare. 2016;54(10):901-906. doi:10.1097/MLR.0000000000000625. 

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Printable Drug Monitoring Attachement

Effective July 1, 2019, Clinical Pathology Laboratories will change the current reagents and instrumentation for lymphocyte subset analysis and enumeration to the Beckman Coulter AQUIOS CL Flow Cytometry System using AQUIOS Tetra-1 and Tetra-2+ Panels.
NOTE: Adult reference ranges and specimen stability will be updated concurrent with this change.

Fluorochrome

The AQUIOS CL is a fully automated flow cytometry system based on precise volumetric sampling to produce efficient, high-throughput lymphocyte subset analysis. In the clinical diagnosis and management of immune deficiency diseases, accuracy and precision in the enumeration of relative (percent) and absolute lymphocyte subsets is critical. The volumetric AQUIOS CL method eliminates the need for and variability produced by the introduction of fluorescent beads to the specimen. The platform is validated for identification and enumeration of T, B, and NK lymphocytes in whole blood.

*Unchanged from previous version

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Effective March 4, 2019

Clinical Pathology Laboratories (CPL) will change current immunochemistry instrumentation and reagents to Roche COBAS® Electrochemiluminescent (eCLIA) methodology for the following assays:

• Adrenocorticotropic hormone (ACTH)
• C-peptide
• Dehydroepiandrosterone sulfate (DHEA-S)
• Human growth hormone (HGH)
• Insulin-like growth factor 1 (IGF-1)
• Insulin-like growth factor binding protein 3 (IGF-BP3)
• Intact parathyroid hormone (iPTH)

The Roche assays provide improved precision and sensitivity, partially due to high-specificity biotin-streptavidin interactions in the immunoassay.1 As a result of this change all related reference ranges, specimen requirements, analytic measuring ranges and interferences were reviewed. The reference ranges for all analytes are modified in the validation process, with gender and age-stratification applied as appropriate. For certain assays, previously supplied Tanner charts are not currently available; instead, providers may reference granular gender- and age-stratified normal ranges. The Tanner charts may be reestablished for specific analytes with literature review and after accumulation of population data and analysis.

The reference interval changes have been distributed to the interfaced laboratory users group in a separate communication. If you or your practice requires a chart of the reference intervals across gender or age, please contact your CPL Account Representative.

Laboratory reports will be appended with a notice of the change in reference range and method as a part of this transition. As always, please review your laboratory results in the context of the provided reference interval and flagging.

Please contact your CPL Account Representative should you have any questions regarding this change.

¹ Assays may be susceptible to interference by high doses (e.g. >5 mg/day) of biotin. Patients should avoid high dose biotin supplements for at least 8 hours prior to phlebotomy.

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Dear CPL Client,

We have just received a notice from Beckman-Coulter, the manufacturer of our Thyroglobulin Antibody assay reagent, that a possibility exists for decreased sensitivity for Thyroglobulin Antibody detection in a subset of patient samples tested with specific lot numbers of reagent. CPL was provided with the impacted lot numbers to test patients during the time period of 11/4/2018 to 2/19/2019. CPL immediately replaced this reagent lot with a new formulation not affected by this issue.

With potentially decreased sensitivity for TG Antibody, the impacted results may be inconsistent with clinical presentation, other laboratory tests, or imaging results. If you suspect that this issue impacted your patients’ results, please contact your CPL Account Representative to review and arrange for reassessment. For clinical questions regarding this testing, please contact customer service at 800.633.4757.

We regret the inconvenience that this may cause you and your patients.

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Effective December 10, 2018,

Clinical Pathology Laboratories (CPL) will no longer offer Helicobacter pylori (H. pylori) serology testing in support of the current diagnostic guidelines for H. pylori. The Effective December 10, 2018, Clinical Pathology Laboratories (CPL) will no longer offer Helicobacter pylori (H. pylori) serology testing in support of the current diagnostic guidelines for H. pylori.

The discontinued tests are as follow:

CPL recommends the following alternative assays:

To better support high quality patient care, CPL will inactivate the serology test codes for H. pylori listed above and recommend active infection assays. These changes are consistent with the current diagnostic guidelines of the American College of Gastroenterology (ACG) and the American Gastroenterology Association (AGA) that recommend either the urea breath test or the stool antigen test as preferred testing modalities for active H. pylori infection. These alternative noninvasive testing methods demonstrate higher clinical utility, sensitivity and specificity.

Serologic evaluation of patients to determine the presence or absence of H. pylori infection is no longer considered clinically useful. As a result, many insurance providers are no longer providing coverage to patients for serologic testing. Antibody tests cannot distinguish between active and past infection with adequate sensitivity and specificity. Despite older literature suggesting that IgG serology can be used as a test of cure after 18 months, this has shown to be inaccurate. Both the urea breath test and stool antigen test are FDA cleared for use as a test of eradication.

Please contact your CPL Account Representative should you have any questions regarding this change.

Choosing Wisely: Fifteen Things Physicians and Patients Should Question, 2016; American Society for Clinical Pathology (ASCP)

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Laboratory tests such as immunoassays use antibodies to detect and quantitate analytical compounds and often use a biotin linker to enhance sensitivity and accuracy. High dose biotin taken within 1 or 2 days or lower dose biotin taken within a few hours prior to sampling may affect the accuracy of laboratory testing for those assays that include a biotin component. 

As a consequence, the US Food and Drug Administration (FDA) has issued a Safety Communication: The FDA Warns that Biotin May Interfere with Lab Tests (https://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm586505.htm). 

What does this mean for patients and providers?

• Patients on high dose supplements of biotin, such as hair/nail/skin supplements, should refrain from taking them in the 24 hours prior to laboratory testing.
• These supplements may or may not indicate they contain biotin prominently.
• Patients taking prescribed megadose regiments (>150 mg biotin) should refrain from taking the supplement for 24-48 hours prior to laboratory testing, upon the advice of their physician.
• Patients and physicians should review any lab test result that does not match the clinical presentation and consider if biotin interference is present. 

 Background information:

• Biotin, or vitamin B7, is often found in multi-vitamins, prenatal vitamins, and dietary supplements, which may not be clear from the name of the supplement.
• Patients and clinicians should be aware that a number of immunoassay lab tests, including but not limited to cardiovascular diagnostic tests, thyroid tests, and certain other hormone tests, may be affected by biotin interference.
• The US recommended daily allowance (US RDA) for biotin is 0.03 mg.

1. The amount of biotin often found in multivitamins does not typically cause significant interference.
2. Supplements containing high biotin levels including those marketed for hair, skin, and nail benefits may contain 5-20 mg of biotin (200-600 times US RDA).
3. Biotin levels higher than the recommended daily allowance may cause significant interference with affected lab tests. 

 References:

• The FDA Warns that Biotin May Interfere with Lab Tests: FDA Safety Communication. Date Issued: 11/28/2017 https://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm586505.htm
• Kummer, S et al. Biotin Treatment Mimicking Graves’ Disease. NEJM 2016; 375:704-706.
• Paxton, Anne. Beauty fad’s ugly downside: test interference. CAP Today. September 2016.

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Effective September 10, 2018

Clinical Pathology Laboratories (CPL) will no longer offer BNP (order code 5585). Consider NT-proBNP (order code 5722) as replacement. NT-proBNP offers better stability and reduced interference to common Neprilysin inhibitors.

Atrial- and brain-type natriuretic peptides (ANPs and BNPs) are produced in cardiac tissues in response to ventricular dysfunction and atrial distension.

NT-proBNP aids in the:

• Diagnosis and prognosis of individuals suspected of having congestive heart failure
• Risk stratification of patients with acute coronary syndrome and congestive heart failure
• Assessment of increased risk of cardiovascular events and mortality in patients at risk for heart failure who have stable coronary artery disease

NT-proBNP, in contrast to Brain Natriuretic Peptide (BNP), is:

• Unaffected by the new class of Neprilysin Inhibitors (e.g. Entresto)
• Suitable as a biomarker for congestive heart failure
• Stable when collected, stored and transported at ambient, refrigerated and frozen temperatures

The table below demonstrates NT-proBNP performance characteristics by age range.

If you have concerns about patients with known BNP baselining, please contact your CPL Account Representative.

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Date: June 4, 2018

To: CPL Client

From: Compliance Department

Re: Annual Notice to Physicians

Clinical Pathology Laboratories (CPL) is providing annual notification to our clients of the Medicare policies governing the ordering and reimbursement of laboratory tests. CPL is committed to promoting awareness of and adherence to these policies. In accordance with the Office of the Inspector General’s (OIG) Compliance Program Guide for Clinical Laboratories, we are providing the following information about Medicare requirements.

Medicare Medical Necessity Policy

Medicare will only pay for the tests that meet the Medicare definition of “medical necessity”. Medicare may deny payment for a test that the physician believes is appropriate, such as a screening test, but which does not meet the Medicare definition of medical necessity. 

Medicare Laboratory National Coverage Determinations (NCDs) and Local Coverage Determinations (NCDs)

Coverage determination policies define the medical conditions through the inclusion of a list of ICD (diagnosis) codes for which these tests are covered or reimbursed by Medicare. HIPAA regulations require ICD code(s) to be present on each claim filed. These codes must also be documented in the patient’s medical records.

NCDs: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/LabNCDsICD10.html

LCDs: https://www.novitas-solutions.com Novitas Solutions Jurisdiction H

Frequency Limitations for Laboratory Tests

Certain laboratory tests have specific frequency limitation requirements. The limitations may apply to tests from the laboratory NCDs and LCDs.

Medicare Preventive Screening Laboratory Tests

Certain preventive screening laboratory tests are covered services for Medicare beneficiaries. Benefit coverage is specific for each service, covered diagnosis codes(s), coverage requirements, and frequency limitations.

https://www.cms.gov/Medicare/Prevention/PrevntionGenInfo/medicare-preventive-services/MPSQuickReferenceChart-1.html

American Medical Association (AMA) Organ or Disease-Oriented Panels The (AMA) panels were developed for coding purposes only and should not be interpreted as clinical parameters. Organ and disease-oriented panels will only be paid by Medicare when all tests within the panel are deemed medically necessary by Medicare. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c16.pdf

Section 90.2 – Organ or Disease Oriented Panels

Reflex Testing

Reflex testing occurs when initial test results are positive or outside normal parameters and indicate that a second related test is medically appropriate or required by state, regulatory or accreditation standards. 
Advance Beneficiary Notice of Non-Coverage (ABN)

• Limited Coverage – An ABN is required if the diagnosis is not covered
• Frequency Limit - An ABN is required at each encounter for frequency limited tests
• Non-Coverage – An ABN is required for experimental or research use tests or tests designated by Medicare an non-covered

https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs.html Manual 100-04 Medicare Claims Processing Manual

Chapter 30 Financial Liability Protections Section 50 Form CMS-R-131 Advance Beneficiary Notice of Non-Coverage (ABN) 2018 Medicare Clinical Laboratory Fee Schedule Effective January 1, 2018, CLFS rates are based on weighted median private payor rates as required by the Protecting Access to Medicare Act (PAMA) of 2014 https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Clinical-LaboratoryFee-Schedule-Files.html Additional details can be found at PAMA regulations. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/PAMARegulations.html Medicare Part B National Correct Coding Initiative (NCCI) Edits The Medicare NCCI was implemented to promote national correct coding methodologies and to control improper coding leading to inappropriate payment. https://www.cms.gov/Medicare/Coding/NationalCorrectCodInitEd/index.html
Contact Information The Medical Directors and other pathologists are available to discuss appropriate testing and test ordering. Please call 512.339.1275 or 800.595.1275 for assistance. You may also contact our Compliance Department at compliancedept@cpllabs.com. Please review this notice with all appropriate staff. 

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Effective June 18, 2018, Clinical Pathology Laboratories (CPL) will no longer offer in-house testing for Cancer Antigen 27.29 (CA 27.29) due to manufacturer reagent unavailability. Cancer Antigen (CA 15-3), order code 4827, testing is routinely performed in-house and may be considered an appropriate alternative.

Both CA 27.29 and CA 15-3 are mucin antibodies which detect soluble forms of MUC-1, a transmembrane mucin which can become overexpressed in epithelial cancer cells. Analytic antibodies for CA 27.29 partially overlap the binding sites used for CA 15-3 testing, yielding clinically similar results. According to Centers for Medicare and Medicaid Services (CMS) policy, CA 27.29 is equivalent to CA 15-3 in its usage in management of patients with breast cancer. Serial tumor marker testing must be used in conjunction with other clinical methods for monitoring breast cancer. If medically necessary for monitoring, clinicians should consistently use either CA 15-3 or CA 27.29, not both. CPL will offer rebaselining for initial transition from CA 27.29 to CA 15-3 from June 18, 2018 to August 31, 2018.

Please contact your Account Executive should you have any questions regarding rebaselining and testing details.

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Effective 06/18/2018, Clinical Pathology Laboratories (CPL) will replace current drug of abuse (DAU) screening and screening with reflex confirmation profiles.

The new profiles provide:

• Reformulation and recombination of classes for profile testing, more relevant to current societal trends
• Standardization of drug thresholds to high sensitivity cutoff values
• Addition of the following analytes in specific profiles for testing:
  • Fentanyl  
  • Buprenorphine
  • 6-Acetylmorphine
  • MDMA (Ecstasy)
• Expansion of testing for adulterants with disqualifying comments added to specimens determined to be altered
• Expansion of interpretive notes on reports regarding the method, cutoff values, and specific drugs that may or may not be detected by the screening method

Additional information for the newly added analytes:

• Fentanyl: a potent synthetic opioid usually not detectable by standard opiate testing
• Buprenorphine: a semisynthetic opioid receptor partial agonist, used in place of or with methadone for detoxification or opioid replacement therapy
• 6-Acetylmorphine: a heroin metabolite, produced very quickly from the short-lived parent and detectable in the urine for approximately 8 hours after use
• MDMA (Ecstasy): a sympathomimetic stimulant related to amphetamine with significantly fewer CNS stimulant properties than methamphetamine 

 Testing to be eliminated from the screening and screen/reflex profiles:

• Methaqualone (Quaaludes): this drug was discontinued in the US in 1985; screening programs very rarely produce positive results, most of which are determined to be false positives
• Propoxyphene (Darvon): this drug was discontinued in the US in 2010 due to cardiac arrhythmias

The following order codes will be discontinued:

3202, 3203, 3204, 3205, 3206, 3210, 3211, 3212, 3220, 3225, 3250, 3251, 3255, 3258, 3270, 3272, 3285, 3290, 3295, 3296, 5813, 5867, 5869, and 5910.

Order code 3254, formerly known as DRUG ABUSE PANEL 10 WITH OXYCODONE will be modified as represented in the chart on reverse side.

The testing represents conventional drug of abuse screening using immunoassay (IA) methods and, where requested, reflex confirmation by chromatography with mass spectrometry. This IA technology is designed to react at a certain threshold to particular members of a drug class. For some classes certain compounds will not measure above the screen threshold. Additionally, chemically related compounds may trigger a "false positive" screen.

Confirmatory testing is performed for positive screens at an additional charge for those profiles designated “W/CONFIRM” on reverse side. Positive screens are reflexed and performed by a different technology, either gas chromatography with mass spectrometry (GC-MS) or liquid chromatography-mass spectrometry (LC-MS or LC-MS/MS if tandem). The confirmatory testing provides higher sensitivity testing with lower thresholds, definitive analyte identification and quantitation without analytic false positives. 

Additional test information:

Limited Coverage Test for Medicare. Advance Beneficiary Notice of Non-Coverage (ABN) required if diagnosis not covered. Frequency Limit Test for Medicare. Advance Beneficiary Notice of Non-Coverage (ABN) is always required. There must be documentation, by the clinician, in the patient’s medical record, to support the medical necessity and frequency of drug testing on an individual basis.

Please contact your CPL Account Representative should you have any questions regarding this change. 

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Effective March 26, 2018, Clinical Pathology Laboratories will change the current instrumentation for Insulin testing from Siemens Immulite to Roche Cobas e602 using Electrochemiluminescence Immunoassay (ECLIA) technology. As a result of this change, all related reference ranges were reviewed and modified as listed below.

Note: Reference ranges for timed specimens are given presuming a 75 gm oral glucose. The Random reference range presumes standard overnight fast as well.

Additional Test Information:

Please contact your Account Executive should you have any questions regarding this change. 

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Effective April 2, 2018, Clinical Pathology Laboratories is pleased to announce a change in methodology and reference range for Thyroxine Binding Capacity (TBC) and a change in reference range for total thyroxine (T4) with transition to the Roche Cobas electrochemiluminescence immunoassay (ECLIA) method. Traditionally, the excess TBC of serum was indirectly assayed with a T3-resin uptake (T3RU). The Roche ECLIA method is a direct measure of TBC which will also allow a calculated T-Uptake in percentage. Free thyroxine index (FTI), an estimate of the free fraction of T4, is calculated using the TBC and Total T4.

T-Uptake:

• Increased in hyperthyroidism or with decreased unsaturated Thyroid Binding Globulin (TBG)
• Decreased in hypothyroidism or with increased unsaturated TBG

TBC:

• Decreased in hyperthyroidism or with decreased unsaturated TBG
• Increased in hypothyroidism or with increased unsaturated TBG

FTI:

• Historically, FTI was the product of total T4 and T3RU divided by 100
• Using Roche, FTI is the ratio: T4/TBC

Changes in Reporting:

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