Valued Westpac Lab Client and Care Provider,

5th Generation Troponin T Test (Test Code C175)

WestPac Lab 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 greater than or equal to 14 ng/L for Females, greater than or equal to 22 ng/L for Males, and greater than or equal to 19 ng/L for not specified.
Only Li-Heparin Plasma Specimens: Test is not FDA approved on serum. Serum specimens will be rejected.

HIV DUO

WestPac Lab has replaced the “HIV-1/2 Ag/Ab 4Th Gen“ with the “HIV DUO assay” (Roche, HIV DUO) The HIV DUO assay also detects both HIV antibodies and antigen but also has a built in confirmatory test to differentiate the antibodies detected. Positive results are repeated and confirmed immediately and will be reported as “repeatedly reactive”. No additional antibody differentiation required (no send out reflex will be performed). A separate blood sample is still required for qualitative or quantitative PCR to establish definitive diagnosis and viral titer.

STAT Policy Change

Providers should only order STAT if they are able to receive the results in the next 2-6 hours and expect patient management to change in the next 12 hours based on the results. Alternatively, all assays on our STAT menu are finalized by next morning at 8am when ordered as routine test.

STAT results will be available through EMR, Fax, printing, etc.; however, a client service representative will no longer call normal or slightly abnormal results as of March 20th. Critical and alert values will be communicated as soon as results are finalized. Please be ready to receive such calls in a timely manner. Please indicate on the requisition form the phone number you would like us to call if no one is at your office. If you wish to continue to receive phone calls on all of your STAT results, please contact your client service representative.

Also, please be aware that when STAT testing is requested, the laboratory needs to divert resources from normal procedures, which may affect turnaround times for routine specimens. We reserve the right to add a stat fee charge to provide this expedited service. Thank you for your consideration and cooperation in using healthcare resources mindfully.

If you have any questions, please reach out to Dr. Zoltan Nagymanyoki M.D, Ph.D., MBA, medical director at znagymanyoki@westpaclab.com.

Valued Westpac Lab Client and Care Provider,

PC update with SPS is required for Atlas users before February 14th!

At this time we have been informed that Microsoft Corp. is removing Internet Explorer from their products as of mid-February. As the present Atlas silent printing solution, MeadCo Print Control, is dependent on Internet Explorer, Atlas has developed an alternative called SPS, which will work with alternative browsers such as Google Chrome. We have begun coordinating deployment of SPS to the PCs WestPac manages. For client owned PCs, Westpac is going to deploy an Atlas logon message providing the client users with the instructions needed to install SPS on their own PCs. Please follow the instructions provided by Atlas and install SPS before February 14.

Failure to install SPS on PCs may lead to issues with printing out requisitions, results and specimen labels, among other printed outputs from Atlas.

Thank you for your collaboration in advance.

If you have any questions, please reach out to Steve Foroutan Information Technology Manager via email at sforoutan@sonichealthcareusa.com or Dr. Zoltan Nagymanyoki M.D, Ph.D., MBA, medical director at znagymanyoki@westpaclab.com. 

Valued Westpac Lab Client and Care Provider,

NEW TSH normal ranges:

We would like to inform you that our TSH normal ranges are revised based on a 24,000 patient data set. Please find the new TSH normal ranges below. New TSH normal ranges are effective as of January 1, 2023.

NEW Thyroid panel with TSH:
In addition, we have created a new Thyroid panel with TSH to assist with the evaluation of thyroid diseases. Test code E028 includes T3 uptake, Total T4, Free T4, and TSH.

The new test code is different from prior test code E446 by replacing Free Thyroxine Index by direct measurement of Free T4.

T4 circulates in the bloodstream as an equilibrium mixture of free and serum bound hormone. Free T4 (fT4) is the unbound and biologically active form, which represents only 0.03 % of the total T4. The remaining T4 is inactive and bound to serum proteins such as thyroxine binding globulin, TBG (75 %), pre-albumin (15 %), and albumin (10 %).

The determination of free T4 has the advantage of being independent of changes in the concentrations and binding properties of these binding proteins; additional determination of a binding parameter (T-uptake, TBG) is therefore unnecessary. Therefore free T4 is a useful tool in clinical routine diagnostics for the assessment of the thyroid status. It should be measured together with TSH if thyroid disorders are suspected and is also suitable for monitoring thyrosuppressive therapy.

If you have any questions, please reach out to Dr. Zoltan Nagymanyoki M.D, Ph.D., MBA, medical director via email at znagymanyoki@westpaclab.com.

Valued Westpac Lab Client and Care Provider,

WestPac lab is pleased to offer Monkeypox PCR testing at our Sonic Reference Laboratory.

Collection kits with two swabs are now available for request. Please contact your account service representative or call the lab at 562.906.5227 to request supplies.

MONKEYPOX VIRUS PCR (U590)

The information provided below is current as of July 5th, 2022.

Under the guidance of the US Center for Disease Control and Prevention (CDC), WestPac LAbs is closely monitoring the outbreak caused by monkeypox virus (MPXV). To date, over 900 human infections have been confirmed in the US, involving over 28 states.

Sonic Healthcare USA was selected by the CDC as one of 5 laboratories to develop a FDA-approved, high-complexity NAAT (RT-PCR) molecular assay to identify MPXV. Test development is actively underway, and once the validation is complete, we will update providers on additional testing guidelines.

Monkeypox: Interim Guidance from the CDC for Healthcare Providers

• Caused by Monkeypox virus
  • Two clades: Central African (CAC) & West African (WAC). WAC is less virulent, and it is the clade circulating in the 2022 US outbreak.
  • Orthopox genus, which includes variola/smallpox, cowpox. MPXV is NOT related to varicella/chickenpox/shingles.
  • Demonstrates extraordinary resistance to drying, heat, and pH, which leads to environmental persistence. Materials with MPXV may remain infectious for months to years.
• Incubation 6-13 days, up to 21 days.
• Signs/Symptoms
  • Fever, headache, swollen lymph nodes (which may differentiate it from smallpox), respiratory symptoms, and GI symptoms, including diarrhea.
  • Characteristic Rash 
    • May look like pimple or blister.
    • Appears on face, inside of mouth, genitals, and other body parts.
• Laboratory findings – leukocytosis, elevated AST & ALT, low BUN, low albumin.
• Differential diagnosis - Smallpox, chickenpox/shingles, measles, bacterial skin infections, scabies, medication allergies, HSV, and syphilis.
• Spread
  • Direct contact with the rash, respiratory secretions during prolonged face to face contact, intimate contact, fomites, placental transfer, animals handling.
  • Possible for up to several weeks.
• Prevention
  • Avoid contact, good hygiene, PPE.
  • Vaccine – JYNNEOS/Imvanex: inactive virus, FDA approved.
• Complications – bacterial infection, sepsis, dehydration, diarrhea, encephalitis.
• Treatment – For select cases, smallpox anti-viral (TPOXX/tecovirimat) may be indicated, especially for highly vulnerable populations.

Diagnostic/Laboratory Testing Guidelines

• Collect at least two swabs from the same lesion.
• Swab or brush lesion vigorously with two separate sterile swabs. Use a sterile nylon, polyester, or Dacron swab with a plastic, wood, or thin aluminum shaft. Do not use other types of swabs.
• If possible, sample paired specimens from multiple lesions on different parts of the body and with differing appearances. CDC suggests 2-3 lesions total.
• Place swabs in individual sterile containers. CDC can now accept the following specimens:
  • Dry lesion swab
  • Lesion swabs in viral transport media (VTM)
  • Lesion crusts
• Refrigerate (2–8°C) or freeze (-20°C or lower) specimens within an hour after collection.
• The laboratory must receive lesion swabs in VTM and lesion crusts within 7 days of specimen collection.
• Specimens that are greater than 8°C upon receipt will be rejected. Ship on dry ice as category B.
• Send all required material to:
  • California Department of Health, unless authorized to send them directly to CDC.
  • Alternatively, providers may send specimens to WestPac Labs, and the material will be forwarded for MPXV testing at California Department of Health.

Criteria to Guide Evaluation of Monkeypox Cases

Printable Version

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 WestPac Labs:

• All high-throughput SARS-CoV-2 molecular assays performed at WestPac Labs 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.

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

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.

Dear Valued Client,

Westpac Labs would like to provide you information regarding laboratory testing if you encounter suspected cases of the 2019 Novel Coronavirus (2019-nCoV), originating in Wuhan, China. On January 21st,the first case of 2019-nCoV pneumonia was documented in the United States in a 30 year old male returning from Wuhan, China to Seattle Washington... Read More

Effective Monday, September 16, 2019 WestPac Labs Inc, will be making the following updates:

• Laboratory Updates
• Critical and Alert Value List Updates
• Measles IgG Assay Reference Range Updates

Please click here for more detailed information.

January 1, 2019 will bring a greatly anticipated change to our organization.  It is our pleasure to announce that our name will change to WestPac Labs, Inc. This change replaces the following company names, as they will no longer be used:

• Central Coast Pathology Laboratory
• Physician’s Automated Laboratory
• West Pacific Medical Laboratory

This change will unify our California operations to provide the best quality care for the medical communities that we serve. It also reflects our ongoing efforts to maintain and improve upon our service levels to our clients and patients throughout California.

Please be assured that with these changes, a steady constant is our outstanding team of approximately 500 employees and the affiliated pathology groups that live and work in Kern County, The Central Coast, Santa Barbara, and Southern California. All are dedicated to continuing to provide excellent care to our clients, partners, friends and family in the areas we are fortunate to serve.

Under the unified WestPac Labs, Inc. brand, our infrastructure and patient access will extend from San Diego through Los Angeles, Bakersfield and San Luis Obispo to just north of San Francisco. Our new single website will allow these geographic areas to identify their local Patient Service Centers which will improve efficiencies for clients and patients.

We look forward to continuing to serve our patients, clients, and partners for many years to come under our new brand of WestPac Labs, Inc.

If you have additional questions please see our name change FAQs

The FDA Warns: BIOTIN May Interfere with Laboratory Testing

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

The level of biotin typically found in multivitamin tablets does not interfere with laboratory testing.

Affiliated Pathologists of the Central Coast (APCC) is a healthcare organization providing Anatomic and Clinical Pathology services to other healthcare organizations of the California Central Coast. APCC partners with Central Coast Pathology Laboratory and is happy to introduce John Blaustein, M.D. Dr. Blaustein will be providing Hematopathology services for APCC.

In addition to Dr. Blaustein, APCC consists of Dr. R.E. Rocha, Dr. J.B. Hannah, Dr. C.L. Douglas, Dr. B. Firetag, Dr. B. Singer and Dr. Z. Nagymanyoki. Dr. Blaustein is board-certified in Anatomic and Clinical Pathology, with a subspecialty in Hematopathology. After receiving his M.D. degree from the University of Texas, he completed his residency in Anatomic and Clinical Pathology at the University of New Mexico. Subsequently, Dr. Blaustein completed a Hematopathology fellowship at the University of Vermont. Dr. Blaustein’s first position was as Assistant Professor of Pathology at the Wayne State School of Medicine at Harper Hospital. Dr. Blaustein relocated to California where he worked as a Hematopathologist at Kaiser Permanente’s main referral hospital in Los Angeles. Dr. Blaustein later accepted a position at Santa Barbara Cottage Hospital where he was a staff Pathologist for over 27 years. Dr. Blaustein has published a number of articles in peer reviewed journals and has co-authored a Hematology App (Atlas and Glossary for Hematology).

Dr. Blaustein is available to clinicians for ongoing communications or to answer any questions. He can be reached on his cell phone at 805.338.5463 for ongoing communication or to answer any questions.

WestPac Labs. is committed to promoting awareness and adherence to all federal laws and regulations.  In accordance with the Office of Inspector General's (OIG) recommendation, this notice will provide our physician clients valuable information.  The information contained within is intended to aid physician clients and the laboratory comply with the regulations and mitigate risks for all parties. 

PECOS - Medicare Ordering and Referring Information                                    

As of 2014, Medicare requires all physicians or other eligible non-physician practitioners (NPP) to enroll in or have a valid opt-out record with the Center for Medicare and Medicaid Services’ Provider Enrollment, Chain and Ownership System (PECOS) in order to order/refer items or services for Medicare beneficiaries.  Information on the requirement and how to enroll is available at: 

http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/MedicareProviderSupEnroll/index.html

Medical Necessity

Tests that are medically necessary for the diagnosis or treatment of a Medicare patient are covered and will be reimbursed.  Screening or Investigational Use Only tests are not generally covered by Medicare, with some exceptions.  An approved panel must only be ordered when every test in that panel is medically necessary.  If all components of the panel are not medically necessary, individual tests or a less inclusive panel containing only the medically necessary tests should be ordered.  The OIG takes the position that a physician who orders medically unnecessary tests for which Medicare reimbursement is claimed may be subject to civil penalties.  As a Medicare participating provider, Physician’s Automated Laboratory, Inc. has a responsibility to make good faith efforts to ensure that all tests requested are performed and billed in a manner consistent with all federal and state laws and regulations. 

Billing Information

Section 4317 of the Balanced Budget Act of 1997 requires that the physician or other authorized ordering party submit diagnosis information on the laboratory order for submission of a Medicare claim.  The diagnosis information provided should accurately describe the patient’s condition on the date of service as documented in the patient’s medical record. The laboratory requires the following information to enable the billing department to bill Medicare, Medicaid or other commercial insurance: 

• patients full name
• patient’s complete address, including city state and zip code
• patient’s date of birth and gender
• patient’s insurance (a copy of the patient’s current insurance card is requested)
• ordering physician’s full name
• valid diagnosis code(s) for each test, and
• valid ABN, when mandated by Medicare NCD/LCD policy.

2018 Medicare Clinical Laboratory Fee Schedule

Outpatient clinical laboratory services are paid based on a fee schedule in accordance with Section 1833(h) of the Social Security Act.  Payment is the lesser of the amount billed, the local fee for geographic area, or a national limit.  Co-payments and deductibles do not apply to services paid under the Medicare Clinical Laboratory Fee Schedule.  Medi-Cal reimbursement will be equal to, or less than, Medicare reimbursement.

The 2018 Medicare Clinical Laboratory Fee Schedule can be viewed at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Clinical-Laboratory-Fee-Schedule-Files-Items/18CLAB.html?DLPage=1&DLEntries=10&DLSort=2&DLSortDir=descending

American Medical Association (AMA) Organ and Disease Oriented Panels

AMA panels were developed for coding purposes only and should not be interpreted as clinical parameters. Each component in an AMA-defined panel must be considered medically necessary when ordering. 

Custom Profiles

WestPac Labs. does not encourage the use of custom profiles, however, in instance where clients insist on customization, the client is advised that custom profiles require a signed Physician Acknowledgement Form (PAF) upon inception with annual renewal thereafter.  Custom profiles will not be created without completion of this form nor will they remain active without annual renewal.  The PAF details CPT codes and the Medicare and Medi-Cal reimbursement paid for each component of the profile.  Please be advised that ordering custom profiles may result in the ordering of tests which are not covered, reasonable or necessary and the OIG takes the position that an individual who knowingly causes a false claim to be submitted may be subject to sanctions or remedies available under civil, criminal an administrative law.

Medical Laboratory  National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs).

Centers for Medicare and Medicaid Services (CMS) has established National Coverage Determinations (NCD) that place restrictions on certain tests for Medical Necessity or Utilization.  California Medicare carrier Noridian, has published Local Coverage Determinations (LCD) for certain tests.  These polices define the medical conditions for which these tests are covered or reimbursed by Medicare.  For these tests, the ordering provider is required to provide diagnostic information that supports the medical necessity for the test. 

LCDs may be viewed at: https://www.cms.gov/medicare-coverage-database/indexes/lcd-state-index.aspx

NCDs may be viewed at: https://www.cms.gov/medicare-coverage-database/indexes/lab-ncd-index.aspx

Advance Beneficiary Notice of Noncoverage (ABN)

Not all laboratory services are covered by Medicare. For statutorily excluded services, the laboratory may bill Medicare patients directly. For certain other laboratory tests, an Advance Beneficiary Notice of Noncoverage (ABN) is used to document that the patient has been made aware that Medicare may not pay for services and has agreed to pay the laboratory in the event payment is denied. A separate ABN must be used for each encounter.  ABN’s must be collected prior to services being rendered.  Client-collected ABN's must be attached to the requisition when samples are submitted to the laboratory.  The laboratory will be responsible for collecting the ABN from the patient only when there is a face to face interaction between the patient and the laboratory.  More information is available at:  https://www.cms.gov/Medicare/Medicare-General-Information/BNI/ABN.html

Medicare Preventive Screening Laboratory Tests

Certain preventive screening laboratory tests are covered benefits for Medicare patients.

Benefit coverage is specific for each service, covered diagnosis codes, coverage requirements, and frequency limitations.  A full list of tests may be viewed at:  https://www.cms.gov/Medicare/Prevention/PrevntionGenInfo/medicare-preventive-services/MPS-QuickReferenceChart-1.html

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 for patient care.  There are two types of reflex testing protocols – required and optional reflex tests.

(a) Required Reflex Tests

Laboratory tests which, if positive, require additional separate follow-up testing in order to have clinical value.  Reflex tests required by state, regulatory or accreditation standards are also considered to be of this type.

(b) Optional Reflex Tests

Laboratory tests where the initial test results may have clinical value without the additional reflex testing.

Clinical Consultant/Medical Director

The Laboratory Medical Director is available to provide guidance as requested.

Performing Laboratory                    Director Name                   Director Contact Information___

Bakersfield Laboratory:                         James Hannah, MD            (661) 325-0744       jhannah@westpaclab.com

Central Coast Laboratory:                    Brandi Firetag, MD              (805) 541-6033       bfiretag@westpaclab.com

West Pacific Medical Laboratory:     Ronald Rocha, MD              (562) 906-5227       rrocha@westpaclab.com

Supply Provision

The laboratory provides supplies that are used solely to collect, transport, process, or store specimens referred to our laboratory.  Supplies are filled according to utilization. 

Attachments

The pages that follow will provide you and your staff with additional resources.  Please take a moment to review and/or disseminate this information accordingly.  We value your business and appreciate the opportunity to serve your laboratory needs in conjunction with these initiatives. 

Laboratory tests where the initial test results may have clinical value without the additional reflex testing.

Clinical Consultant/Medical Director

The Laboratory Medical Director is available to provide guidance as requested.

Performing Laboratory                    Director Name                   Director Contact Information___

Bakersfield Laboratory:                                   James Hannah, MD               (661) 325-0744      jhannah@pallab.org

Central Coast Pathology Laboratory:       Michael V. Frost, MD              (805) 541-6033      mfrost@ccpathology.com

West Pacific Medical Laboratory:               Ronald Rocha, MD                 (562) 906-5227       rrocha@ccpathology.com

Supply Provision

The laboratory provides supplies that are used solely to collect, transport, process, or store specimens referred to our laboratory.  Supplies are filled according to utilization. 

Attachments

The pages that follow will provide you and your staff with additional resources.  Please take a moment to review and/or disseminate this information accordingly.  We value your business and appreciate the opportunity to server your laboratory needs in conjunction with these initiatives. 

• AMA Defined Organ or Disease Oriented Panels
• Reflex Tests