An accountable care organization (ACO) is a group of doctors, hospitals and health care providers who work together to provide higher-quality coordinated care to their patients, while helping to slow health care cost growth. It is characterized by a payment and care delivery model that seeks to tie provider reimbursements to quality metrics and reductions in the total cost of care for an assigned population of patients.
The ACO may use a range of payment models capitation, fee-for-service or bundled payments, etc.). The ACO is accountable to the patients and the third-party payer for the quality, appropriateness and efficiency of the health care provided. According to the Centers for Medicare and Medicaid Services (CMS), an ACO is “an organization of health care providers that agrees to be accountable for the quality, cost, and overall care of Medicare beneficiaries who are enrolled in the traditional fee-for-service program who are assigned to it.”
The success of the ACO model in fostering clinical excellence while simultaneously controlling costs depends on its ability to “incentivize hospitals, physicians, post-acute care facilities, and other providers involved to form linkages and facilitate coordination of care delivery, according to A National Strategy to put Accountable Care into Practice. Health Affairs by Dr. Mark McClellan, former administrator of the Centers for Medicare & Medicaid Services (CMS) and former commissioner of the U.S. Food and Drug Administration (FDA). By increasing care coordination, ACOs can help reduce unnecessary medical care and improve health outcomes, leading to a decrease in utilization of acute care services.
Healthcare quality delivered by an ACO is defined by CMS via five domains. They are “patient/caregiver experience, care coordination, patient safety, preventative health, and at-risk population/frail elderly health.”
An ACO’s patient population will primarily consist of Medicare beneficiaries. In larger and more integrated ACOs, the patient population may also include those who are homeless and uninsured. Patients may play a role in the healthcare they receive from their ACOs by participating in their ACO’s decision-making processes.
Anatomic pathology is about diagnosing disease through the examination of organs and tissue samples by using a microscope, or through molecular, biochemical or immunological means.
It differs from clinical pathology, where diseases are diagnosed through analyzing bodily fluids in a lab.
In anatomic pathology, a physician trained in pathology examines surgical specimens (e.g., from a biopsy). This contrasts from clinical pathology, where blood, throat cultures, and urine as sent to a lab for analysis to determine whether a patient either has or is at risk for several biological diseases.
The American Board of Pathology is one of the primary certification organizations for anatomic pathologists. To be certified in anatomic pathology, a physician must complete four years of medical school and three years of residency. To be certified in both anatomic and clinical pathology, a physician must do four years of residency.
Anatomic pathologists typically work in hospitals, and pathology in general is most times practiced in hospitals and academic medical centers, where research is being conducted.
ARUP Laboratories is a nonprofit national clinical and anatomic pathology reference laboratory, and an enterprise of the University of Utah and its Department of Pathology. Based in Salt Lake City, UT, it was founded in 1984. Currently its Chief Executive Officer is Edgar Braendle, MD, PhD.
With more than 3,000 employees, ARUP Lab offers in excess of 3,000 tests and test combinations, ranging from routine screening tests to highly esoteric molecular and genetic assays.
Rather than competing with its clients for physician office business, ARUP Lab supports clients’ existing test menus by offering highly complex and unique lab tests, with accompanying consultative support, to enhance their abilities to provide laboratory services.
ARUP offers diagnostic laboratory testing services to thousands of clients, including academic hospitals, children’s hospitals, multihospital groups, major commercial laboratories, group purchasing organizations, military and government facilities, and major clinics, in all 50 states. It is the reference lab of choice for more than 50 percent of the nation’s university medical centers, pediatric hospitals, and teaching hospitals.
ARUP’s clients include more than half of the nation’s university teaching hospitals and children’s hospitals, as well as regional hospital networks, multihospital groups, major commercial laboratories, group purchasing organizations, military and government facilities, and major clinics.
ARUP Lab is home to more than 60 individual labs specializing in all aspects of clinical and anatomic pathology. The test menu encompasses more than 3,000 tests, including highly specialized and esoteric tests. Comprehensive testing is offered in the areas of pathology, allergy and immunology, chemistry, cytogenetics, endocrinology, fetal risk assessment, genetics, hematology, hepatitis and HIV, infectious diseases, neurology, oncology, genetics, molecular oncology, anatomic pathology, pediatrics, and pain management, among others.
ARUP Lab performs 99 percent of all testing onsite in one central location, operating 24 hours per day, 7 days a week, and processing an average of 45,000–50,000 specimens of blood, body fluid, and tissue biopsies per day.
ARUP is a CLIA-certified diagnostic lab with more than 25 years of experience successfully supporting clinical trials. ARUP has more than 90 medical experts available for client consultation. These professionals hold faculty appointments at the University of Utah School of Medicine; many participate in care teams at the Huntsman Cancer Hospital and Primary Children’s Hospital.
ASCP stands for American Society of Clinical Pathologists. It is a professional association based in Chicago, Illinois encompassing 130,000 pathologists and laboratory professionals.
Founded in 1922, the ASCP provides programs in education, certification and advocacy on behalf of patients, pathologists and lab professionals. In addition, the ASCP publishes numerous textbooks, newsletters and other manuals, and publishes two industry journals: American Journal of Clinical Pathology, the leading clinically oriented peer-reviewed pathology and laboratory medicine research journal, and Labmedicine, a monthly periodical dedicated to providing the entire laboratory community with continuing education, career development and information about emerging technologies. ASCP also publishes Critical Values, a quarterly news magazine.
ASCP provides pathologists, medical affiliates, medical students and laboratory professionals with educational resources and professional development tools including continuing medical education, ASCP certification, networking opportunities, and representation in Washington about issues related to pathology professionals such as increasing laboratory standards, improving healthcare and reaching patients in need.
The ASCP Board of Certification (BOC), with accreditation from the American National Standards Institute, is the oldest and largest certification agency for pathologists and laboratory professionals. The BOC has certified more than 450,000 people since it was founded in 1928 and represents the gold standard for certification of pathologists’ assistants and laboratory professionals.
ASCP supports ongoing learning needs while also helping professionals meet institutional, licensure and MOC or CMP requirements. ASCP is accredited with Commendation by the Accreditation Council for Continuing Medical Education (CME) to provide CME for physicians and continuing medical laboratory education (CMLE) for lab professionals.
Educational programs include online self-studies and assessments, live teleconferences and webcasts and workshops and conferences.
ASCP also offers a variety of activities and tools designed to help pathologists meet Part II and Part IV Maintenance of Certification (MOC) requirements from the American Board of Pathology, and help laboratory professionals meet Certification Maintenance Program (CMP) requirements. In addition to providing tools to obtain CE credits, ASCP’s new online member portal, is available to help professionals navigate the MOC or CMP process.
ASCP certification is the recognition by the American Society for Clinical Pathology Board of Certification that an individual has met certain established requirements for laboratory professionals. The ASCP Board of Certification is an independent certification agency that develops relevant standards and procedures to assure the competence of medical laboratory personnel.
The ASCP BOC acknowledges the importance of impartiality in conducting certification and qualification activities. It manages conflict of interest and ensures objectivity by representative membership on its Board of Governors from other associations and societies.
Certifications and qualification are offered in a number of disciplines and technical areas. Individuals who sit for either a certification are required to meet certain academic and clinical requirements, and achieve a predetermined acceptable performance or competence level. Certification examinations are of fixed-length and time, are criterion referenced and use computer adaptive testing.
The disciplines and technical areas covered by ASCP certification include:
- Technician certifications of histotechnician and phlebotomy, donor phlebotomy and medical laboratory technician
- Technologist certifications of medical laboratory scientist, cytotechnologist, histotechnologist, and technologist in blood banking, chemistry, cytogenetics, hematology, microbiology and molecular biology
- Specialist certification in blood banking, chemistry, cytotechnology, hematology, and microbiology, and pathologist assistant
- Diplomate in laboratory management
ASCP certification is time-limited for three years. To remain valid, practitioners must demonstrate their competence by completion of documented educational activities.
ASCP certification is accepted by all U.S. states and territories and the cities of Abu Dhabi and Dubai for licensure purposes, provided the individual meets all other licensure requirements.
The BOC offers certification study guides, content outlines, and suggested reading lists as resources for taking each certification examination. Online practice tests are also available as a study aid for many of the BOC examinations.
ASCP’s 2013 Wage Survey of U.S. Clinical Laboratories found that certified laboratory professionals earn more than their non-certified counterparts.
Bundled payment, also known as episode-based payment, episode payment, episode-of-care payment, case rate, evidence-based case rate, global bundled payment, global payment, package pricing, or packaged pricing, is defined as the reimbursement of health care providers (such as hospitals and physicians) “on the basis of expected costs for clinically-defined episodes of care.” It has been described as “a middle ground” between fee-for-service reimbursement (in which providers are paid for each service rendered to a patient) and capitation (in which providers are paid a “lump sum” per patient regardless of how many services the patient receives).
Advocates of bundled payments note that unlike fee-for-service, bundled payment discourages unnecessary care, encourages coordination across providers, and potentially improves quality. Unlike capitation, bundled payment does not penalize providers for caring for sicker patients. Bundling payment provides additional advantages to providers and patients alike, through removing inefficiency and redundancy from patient-care protocols; e.g. duplicate testing, delivering unnecessary care, and failing to adequately provide postoperative care.
This method of payment is also said to provide transparency for consumers by fixing pricing and publishing cost and outcomes data. Patients would be able to choose a provider based on a comparison of real data, not word of mouth. Bundled payments may also encourage economies of scale – especially if providers agree to use a single product or type of medical supply – as hospitals or integrated health systems can often negotiate better prices if they purchase supplies in bulk.
On the other hand, the scientific evidence in support of it has been described as “scant.” It does not discourage unnecessary episodes of care; for example, physicians might hospitalize some patients unnecessarily.
Providers may seek to maximize profit by avoiding patients for whom reimbursement may be inadequate (e.g., patients who do not take their drugs as prescribed), by overstating the severity of an illness, by giving the lowest level of service possible, by not diagnosing complications of a treatment before the end date of the bundled payment, or by delaying post-hospital care until after the end date of the bundled payment.
Meanwhile, early evidence indicates that Medicare’s bundled-payment pilot, the Bundled Payment Care Initiative, has helped participating providers improve the quality of care while better managing healthcare costs. Should more detailed findings confirm these outcomes, Medicare could decide to expand the range of clinical services it wants covered by a bundled-payment arrangement.
Capitation is a payment arrangement for health care service providers. It pays a physician or group of physicians a set amount for each enrolled person assigned to them, per period of time, whether or not that person seeks care. These providers generally are contracted with a type of health maintenance organization (HMO) known as an independent practice association (IPA), which enlists the providers to care for HMO-enrolled patients. State-run Medicaid contracts are also being converted to capitation.
The amount of remuneration is based on the average expected health care utilization of that patient, with greater payment for patients with significant medical history. Rates are also affected by age, race, sex, type of employment, and geographical location, as these factors typically influence the cost of providing care.
There are several different types of capitation, ranging from relatively modest per member per month (pmpm) case management payments to primary care physicians, to pmpm payments covering all professional services, to pmpm payments covering the total risk for all services: professional, facility, pharmaceutical, clinical laboratory, durable medical equipments, etc. There are innumerable variations on these basic capitation types, depending on the particular services the parties decide to “carve out” and handle on either a fee-for-service basis or by delegation to a separate benefit management company.
Under capitation, physicians are given incentive to consider the cost of treatment. Pure capitation pays a set fee per patient, regardless of their degree of infirmity, and gives physicians an incentive to avoid the most costly patients. Providers who work under these plans focus on preventive health care, as there is greater financial reward in prevention of illness than in treatment of the ill. Such plans avert providers from the use of expensive treatment options.
Follow the 2014 lead of Oregon’s Medicaid reforms involving a capitation payment model, other states are also forming accountable care organizations that use the capitation model. For clinical laboratories and pathology groups, the expansion of enrollment in Medicaid creates opportunities for labs to provide more testing.
On the other hand, it still remains to be seen if capitated and bundled payments associated with these innovative Medicaid programs further erode the finances of the clinical laboratories and anatomic pathology groups that provide services to the Medicaid beneficiaries enrolled in these programs.
CLIA certification is the requirement under the Clinical Laboratory Improvement Amendments of 1988 that all entities that perform even one test, including waived tests, on … “materials derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, human beings” meet certain Federal requirements. If an entity performs tests for these purposes, it is considered under CLIA to be a laboratory and must register with the CLIA program.
The CLIA certification application collects information about a medical laboratory’s operation, which is necessary to determine the type of certificate to be issued and the fees to be assessed.
All types of CLIA certifications are effective for two years, and the different types of certificates are:
- Certificate of Waiver – Issued to a laboratory that performs only CLIA waived tests
- Certificate for Provider Performed Microscopy (PPM) procedures – Issued to a laboratory in which a physician, midlevel practitioner or dentist performs specific microscopy procedures during the course of a patient’s visit. A limited list of microscopy procedures is included under this certificate type and these are categorized as moderate complexity.
- Certificate of Registration – Issued to a laboratory to allow the laboratory to conduct nonwaived (moderate and/or high complexity) testing until the laboratory is surveyed (inspected) to determine its compliance with the CLIA regulations. Only laboratories applying for a certificate of compliance or a certificate of accreditation will receive a certificate of registration.
- Certificate of Compliance – Issued to a laboratory after an inspection by the state Department of Health that finds the laboratory to be in compliance with all applicable CLIA requirements
- Certificate of Accreditation – Issued to a laboratory on the basis of the laboratory’s accreditation by an accreditation organization approved by CMS. This type of certificate is issued to a laboratory that performs nonwaived (moderate and/or high complexity) testing.
There are six CMS-approved accreditation or organizations:
- American Osteopathic Association
- American Society of Histocompatibility and Immunogenetics
- College of American Pathologists (CAP)
- Joint Commission on Accreditation of Healthcare Organizations
Laboratories that apply for accreditation by one of the CMS-approved accreditation organizations must also apply to CMS for a COA at the same time. Laboratories must apply for the highest-level CLIA certification that covers the tests they perform.
Any laboratory located in a state that has a CMS-approved laboratory program is exempt from CLIA certification. Currently, there are two states with approved programs: Washington and New York (partial exemption).
If CMS or the State Agency receives a complaint against a laboratory, the laboratory may receive an unannounced on site survey, even though it only perform waived tests or PPM procedures.
The following exceptions to CLIA certification apply regardless of a laboratory’s location:
- Any laboratory that only performs testing for forensic purposes
- Research laboratories that test human specimens but do not report patient-specific results for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, individual patients
- Laboratories certified by the Substance Abuse and Mental Health Services Administration (SAMHSA), in which drug testing is performed that meets SAMHSA guidelines and regulations. However, a CLIA certification is needed for all other testing conducted by a SAMHSA-certified laboratory.
As defined by the Clinical Laboratory Improvement Amendments of 1988 (CLIA), waived tests are categorized as “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result”. The Food and Drug Administration (FDA) determines the criteria for tests being simple with a low risk of error and approves manufacturer’s applications for test system waiver.
Tests waived by CLIA also:
- Pose no reasonable risk of harm to the patient if the test is performed incorrectly
- Are cleared by the FDA for home use
- Are considered non-technical requiring little or no difficulty
If a lab is conducting only waived testing, it must have a valid Certificate of Waiver (COW) from CLIA and the lab will not be routinely inspected for laboratory compliance. However, COW labs may be randomly inspected as part of a compliance investigation to ensure that they are only performing waived testing.
Although CLIA waived tests must be simple and have a low risk for erroneous results, this does not mean waived tests are completely error-proof. Errors can occur anywhere in the testing process, particularly when the manufacturer’s instructions are not followed and when testing personnel are not familiar with all aspects of the test system.
Some waived tests have potential for serious health impacts if performed incorrectly. For example, results from waived tests can be used to adjust medication dosages, such as prothrombin time testing in patients undergoing anticoagulant therapy and glucose monitoring in diabetics. In addition, erroneous results from diagnostic tests, such as those for human immunodeficiency virus (HIV) antibody, can have unintended consequences. To decrease the risk of erroneous results, the test needs to be performed correctly, by trained personnel and in an environment where good laboratory practices are followed.
Many waived tests are not done according to designed protocols, with more than 50% of such tests reportedly done incorrectly, and result in medical errors, some with fatal consequences.
The lengthy list of CLIA waived tests can be found here.
A clinical laboratory is a laboratory where tests are done on clinical specimens in order to get information about the health of a patient as pertaining to the diagnosis, treatment, and prevention of disease.
Laboratory medicine is generally divided into two sections, each of which being subdivided into multiple units. These two sections are:
- Anatomic pathology: Units included here are histopathology, cytopathology, and electron microscopy. Other disciplines pertaining to this section include anatomy, physiology, histology, pathology, and pathophysiology.
- Clinical pathology, which includes:
- Clinical Microbiology: This encompasses five different sciences. These include bacteriology, virology, parasitology, immunology, and mycology.
- Clinical Chemistry: Units under this section include instrumental analysis of blood components, enzymology, toxicology and endocrinology.
- Hematology: This section consists of automated and manual analysis of blood cells.
- Genetics is also studied along with a subspecialty known as cytogenetics.
- Reproductive biology: Semen analysis, Sperm bank and assisted reproductive technology.
Credibility of medical laboratories is paramount to the health and safety of the patients relying on the testing services provided by these labs. The international standard in use today for the accreditation of medical laboratories is ISO 15189.
Accreditation is done by the Joint Commission, College of American Pathologists, AAB (American Association of Bioanalysts), and other state and federal agencies. CLIA 88, the Clinical Laboratory Improvement Amendments, also dictate testing and personnel.
In addition, many clinical laboratories have adopted quality management programs such as Six Sigma and Lean quality to improve clinical quality, reduce turnaround time, cut costs, and boost productivity. Lean and Six Sigma are both process improvement methodologies. At a very basic level, Lean is about speed and efficiency, while Six Sigma is about precision and accuracy, leading to data-driven decisions. Lean and Six Sigma methods are finding numerous applications in anatomic pathology laboratories and pathology group practices.
Outpatient clinical laboratory services are paid based on the Medicare Part B Clinical Laboratory Fee Schedule (CLFS) in accordance with Section 1833(h) of the Social Security Act. Payment is the lesser of the amount billed, the local fee for a geographic area, or a national limit. In accordance with the statute, the national limits are set at a percent of the median of all local fee schedule amounts for each laboratory test code. Each year, fees are updated for inflation based on the percentage change in the Consumer Price Index. However, legislation by Congress can modify the update to the fees.
Co-payments and deductibles do not apply to services paid under the Medicare clinical laboratory fee schedule.
Each year, new laboratory test codes are added to the clinical laboratory fee schedule and corresponding fees are developed in response to a public comment process. Also, for a cervical or vaginal smear test (Pap smear), the fee cannot be less than a national minimum payment amount, initially established at $14.60 and updated each year for inflation.
Critical access hospitals are paid for outpatient laboratory services on a reasonable cost basis, instead of by the fee schedule. Hospitals with fewer than 50 beds in qualified rural areas—those with population densities in the lowest quartile of all rural areas—are paid based on a reasonable cost basis for outpatient clinical laboratory tests for cost reporting periods between July 2004 and July 2006.
The Protecting Access to Medicare Act of 2014 (PAMA) that became law on April 1, 2014, required labs to report such data and the test volumes associated with that data, beginning on Jan. 1, 2016.
On Jan. 1, 2017, CMS will use the market data to set prices for the Part B Clinical Laboratory Fee Schedule. As currently written, PAMA specifies that CMS cannot cut the price of a specific lab test by more than 10% in each of 2017, 2018, and 2019, nor by more than 15% in each of 2020, 2021, and 2022. There is no limit on price reductions outlined in the law for years following 2022.
The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). These regulations include federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease.
In total, CLIA covers approximately 251,000 laboratory entities. The Division of Laboratory Services, within the Survey and Certification Group, under the Center for Clinical Standards and Quality (CCSQ) has the responsibility for implementing the CLIA Program.
The objective of the CLIA program is to ensure quality laboratory testing. All clinical laboratories must be properly certified to receive Medicare or Medicaid payments.
CLIA regulations require clinical laboratories to be certificated by their state as well as the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing. Laboratories can obtain multiple types of CLIA certificates, based on the kinds of diagnostic tests they conduct.
Three federal agencies are responsible for CLIA: The Food and Drug Administration (FDA), Center for Medicaid Services (CMS) and the Center for Disease Control (CDC). Each agency has a unique role in assuring quality laboratory testing.
- Categorizes tests based on complexity
- Reviews requests for Waiver by Application
- Develops rules/guidance for CLIA complexity categorization
- Issues laboratory certificates
- Collects user fees
- Conducts inspections and enforces regulatory compliance
- Approves private accreditation organizations for performing inspections, and approves state exemptions
- Monitors laboratory performance on Proficiency Testing (PT) and approves PT programs
- Publishes CLIA rules and regulations
- Provides analysis, research, and technical assistance
- Develops technical standards and laboratory practice guidelines, including standards and guidelines for cytology
- Conducts laboratory quality improvement studies
- Monitors proficiency testing practices
- Develops and distributes professional information and educational resources
- Manages the Clinical Laboratory Improvement Advisory Committee (CLIAC)
Clinical pathologists work in hospital labs and pathology groups to practice as consultant physicians, developing and applying knowledge of tissue and laboratory analyses to assist in the diagnosis and treatment of individual patients. As scientists, they use the tools of laboratory science in clinical studies, disease models, and other experimental systems, to advance the understanding and treatment of disease.
Clinical pathologists in a pathology group administer a number of visual and microscopic tests and an especially large variety of tests of the biophysical properties of tissue samples involving automated analyzers and cultures. Sometimes the general term “laboratory medicine specialist” is used to refer to those working in clinical pathology, including medical doctors, PhDs and doctors of pharmacology.
According to the world’s largest professional membership organization for clinical pathologists and laboratory professionals, the American Society for Clinical Pathology (ASCP), “Pathologists are problem-solvers, fascinated by the process of disease and eager to unlock medical mysteries, like AIDS and diabetes, using the tools of laboratory medicine and its sophisticated instruments and methods. Pathologists make it possible to apply scientific advances to improve the accuracy and efficiency of medical diagnosis and treatment.”
Becoming a pathologist entails one of the lengthiest education and training tracks of all physicians. Requirements include four years of undergraduate study, plus four years of medical school, plus a minimum of four to five years of post-graduate training in pathology residency.
The American Board of Pathology certifies clinical pathologists, and recognizes the following secondary specialties of clinical pathology:
- Chemical pathology, also called clinical chemistry
- Blood banking / transfusion medicine
- Clinical microbiology
- Molecular genetics pathology
Clinical pathologists work in close collaboration with clinical scientists (clinical biochemists, clinical microbiologists, etc.), medical technologists (MTs), clinical laboratory scientists (CLS), hospital administrators, and referring physicians to ensure the accuracy and optimal utilization of laboratory testing.
Clinical pathology is one of the two major divisions of pathology, the other being anatomic pathology. Often, pathologists practice both anatomical and clinical pathology, a combination sometimes known as general pathology.
According to the ASCP, “there are approximately 12,000 board certified pathologists in the U.S. who practice their specialty in community, university, and government hospitals and clinics, in independent laboratories, or in private offices, clinics, and other health care facilities.”
Clinical pathology is a medical specialty that is concerned with the diagnosis of disease based on the laboratory analysis of bodily fluids, such as blood, urine, and tissue homogenates or extracts using the tools of chemistry, microbiology, hematology and molecular pathology. This specialty requires a medical residency.
Clinical pathologists often direct all of the special divisions of the laboratory, which may include the blood bank, clinical chemistry and biology, toxicology, hematology, immunology and serology, and microbiology. Clinical pathology also involves maintenance of laboratory information systems, research, and quality control.
According to the American Association of Medical Colleges, “The practice of pathology is most often conducted in community hospitals or in academic medical centers, where patient care, diagnostic services, and research go hand in hand. Creation of new knowledge is the lifeblood of pathology and many academic pathologists devote significant time in their career to research.”
The world’s largest professional membership organization for clinical pathologists and laboratory professionals, the American Society for Clinical Pathology (ASCP), says, “Pathologists are problem-solvers, fascinated by the process of disease and eager to unlock medical mysteries, like AIDS and diabetes, using the tools of laboratory medicine and its sophisticated instruments and methods. Pathologists make it possible to apply scientific advances to improve the accuracy and efficiency of medical diagnosis and treatment.”
Becoming a pathologist entails one of the lengthiest education and training tracks of all physicians. Requirements include four years of undergraduate study, plus four years of medical school, plus a minimum of four to five years of post-graduate training in pathology residency. The annual salary for clinical pathologists ranges from $183,000 to $360,000.
The American Board of Pathology certifies clinical pathologists, and recognizes the following secondary specialties of clinical pathology:
- Chemical pathology, also called clinical chemistry
- Blood banking / transfusion medicine
- Clinical microbiology
- Molecular genetics pathology
Tools of clinical pathology include macroscopic examination, microscopes, microscopical examination, analyzers, centrifuges and cultures.
The ASCP has more than 100,000 members worldwide, and “provides excellence in education, certification and advocacy on behalf of patients, pathologists and laboratory professionals across the globe.”
A companion diagnostic device can be an in vitro diagnostic device or an imaging tool that provides information that is essential for the safe and effective use of a corresponding therapeutic product. The use of an IVD companion diagnostic device with a particular therapeutic product is stipulated in the instructions for use in the labeling of both the diagnostic device and the corresponding therapeutic product, as well as in the labeling of any generic equivalents and biosimilar equivalents of the therapeutic product.
Because the companion diagnostic test is designed to be paired with a specific drug, the development of both products requires close collaboration between experts in both the Food and Drug Administration (FDA)’s device center, which evaluates the test to determine whether it may be cleared or approved, and FDA’s drug center, which evaluates the drug to determine whether it may be approved.
The process works best when development of the test begins before the drug enters clinical trials, increasing the likelihood that the participants in the trials are the patients most likely to benefit from the treatment.
Companion diagnostics can provide information such as the following:
- Test results that identify a population in which the therapeutic product will achieve greater (or little) effectiveness
- Test results that identify a patient population that should not receive a particular therapeutic product due to the possibility for therapy-related serious adverse events
- Test results that identify the characteristics of a disease, condition, or disorder to specifically determine what type of treatment is appropriate
- Test results that are the basis for selecting a safe and efficacious therapeutic dose.
Development of companion diagnostics has been supported by regulatory agencies, such as the FDA. The biopharmaceutical industry has also embraced the co-development of companion diagnostics, with companies either partnering on their development or pursuing in-house programs.
Genetic Engineering & Biotechnology News notes that a frequently cited example of a successful personalized therapeutic and companion diagnostic pair is Genentech’s antibody-based drug, Herceptin® (trastuzumab), which treats patients with cancers that overexpress the HER2 receptor (such as breast cancer), and the companion diagnostic test, HercepTest. The diagnostic test was developed to select patients that will benefit from treatment with Herceptin, a blockbuster drug.
The virus that causes a respiratory disease called coronavirus disease (COVID-19). SARS-CoV-2 is a member of a large family of viruses called coronaviruses. These viruses can infect people and some animals. SARS-CoV-2 was first known to infect people in 2019. The virus is thought to spread from person to person through droplets released when an infected person coughs, sneezes or talks. It may also be spread by touching a surface with the virus on it and then touching one’s mouth, nose, or eyes. Research is being done to treat COVID-19 and to prevent infection with SARS-CoV-2. Also called severe acute respiratory syndrome coronavirus 2.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the strain of coronavirus that causes coronavirus disease 2019 (COVID-19), the respiratory illness responsible for the COVID-19 pandemic. Colloquially known as simply the coronavirus, it was previously referred to by its provisional name, 2019 novel coronavirus (2019-nCoV), and has also been called human coronavirus 2019 (HCoV-19 or hCoV-19)
SARS-CoV-2 is a new type of coronavirus that can affect people. It was first detected in December 2019, in Wuhan City, Hubei Province, China. In 80% of cases, it produces only mild respiratory symptoms.
The virus is known as Coronavirus SARS-CoV-2 and the disease that it causes is COVID-19.
Rapid antigen tests are commonly used in the diagnosis of respiratory pathogens, including influenza viruses and respiratory syncytial virus (RSV). The FDA has granted emergency use authorization (EUA) for antigen tests that can identify SARS-CoV-2.
An antigen test reveals if a person is currently infected with a pathogen such as the SARS-CoV-2 virus. Once the infection has gone, the antigen disappears.
This COVID-19 test detects certain proteins in the virus. Using a long nasal swab (nasopharyngeal swab) or throat swab to get a fluid sample, antigen tests can produce results in minutes.
Molecular diagnostics is a collection of techniques used to analyze biological markers in the genome and proteome—the individual’s genetic code and how their cells express their genes as proteins—by applying molecular biology to medical testing. The technique is used to diagnose and monitor disease, detect risk, and decide which therapies will work best for individual patients.
As the primary clinical manifestation of COVID-19 is a respiratory illness, PCR tests are generally used to test samples obtained from the upper or lower respiratory tract. Appropriate upper respiratory sample types include a nasopharyngeal swab or a throat swab.
Currently there are two types of diagnostic tests— molecular tests, such as RT-PCR tests, that detect the virus’s genetic material, and antigen tests that detect specific proteins from the virus.
The COVID-19 RT-PCR test is a real-time reverse transcription polymerase chain reaction (rRT-PCR) test for the qualitative detection of nucleic acid from SARS-CoV-2 in upper and lower respiratory specimens (such as nasopharyngeal or oropharyngeal swabs, sputum, lower respiratory tract aspirates, bronchoalveolar lavage, and nasopharyngeal wash/aspirate) collected from individuals suspected of COVID-19 by their healthcare provider (HCP), as well as upper respiratory specimens (such as nasopharyngeal or oropharyngeal swabs, nasal swabs, or mid-turbinate swabs) collected from any individual, including for testing of individuals without symptoms or other reasons to suspect COVID-19 infection.
Polymerase chain reaction (PCR) is a method widely used to rapidly make millions to billions of copies of a specific DNA sample, allowing scientists to take a very small sample of DNA and amplify it to a large enough amount to study in detail. PCR was invented in 1984 by the American biochemist Kary Mullis at Cetus Corporation.
RT-PCR is a laboratory-based technique used for detecting and comparing the levels of ribonucleic acid (RNA) and the surface proteins in a sample, particularly samples with limited quantities of RNA.
A rapid diagnostic test (RDT) is a medical diagnostic test that is quick and easy to perform. RDTs are suitable for preliminary or emergency medical screening and for use in medical facilities with limited resources. They also allow point-of-care testing in primary care for things that formerly only a laboratory test could measure. They provide same-day results within 2 hours, typically in approximately 20 minutes.
Simple/Rapid tests are designed for use where a preliminary screening test result is required and are especially useful in resource-limited countries.
Rapid diagnostic tests (RDTs) most often use a dipstick or cassette format, and provide results in about 20 minutes. A blood specimen collected from the patient is applied to a sample pad on the test card along with certain reagents.
The Current Procedural Terminology (CPT)® code set is a medical code set maintained by the American Medical Association through the CPT Editorial Panel. The CPT (copyright protected by the AMA) describes medical, surgical, and diagnostic services and is designed to communicate uniform information about medical services and procedures among physicians, coders, patients, accreditation organizations, and payers for administrative, financial, and analytical purposes.
CPT codes are a critical part of the laboratory billing process. They are similar to ICD-9 and ICD-10 coding, except that it identifies the services rendered rather than the diagnosis on the claim. CPT is currently identified by the Centers for Medicare and Medicaid Services (CMS) as Level 1 of the Healthcare Common Procedure Coding System (HCPCS).
The AMA’s CPT Editorial Panel engages in an ongoing process improvement effort that frequently includes re-examination of the CPT Category I and Category III criteria.
CPT Category I codes are the codes most used in clinical lab and pathology group billing. They are the five-digit numeric codes included in the main body of CPT. These codes represent procedures that are consistent with contemporary medical practice and are widely performed. Codes assigned to this category have met certain criteria including:
- Procedure or service approved by the Food and Drug Administration (FDA)
- Procedure or service commonly performed by health care professionals nationwide
- Procedure or service’s clinical efficacy is proven and documented
The use of the code is mandated by almost all health insurance payment and information systems, including the Centers for Medicare and Medicaid Services (CMS) and HIPAA, and the data for the code sets appears in the Federal Register.
After a clinical laboratory service is provided, diagnosis and procedure codes such as CPT codes are assigned to assist the insurance company in determining coverage and medical necessity of the services. Once the procedure and diagnosis codes are determined, the lab bill enters the laboratory collections/revenue cycle management phase.
Diagnostic technology involves tests, assays and equipment that allow clinical labs to diagnose diseases. New diagnostic technologies are currently transforming both infectious disease testing and cancer testing. Rapid molecular tests, for example, make it possible for medical labs to deliver an accurate answer back to a referring physician in just hours—compared to the several days that are required for most long-standing microbiology test procedures.
Even more disruptive technologies include digital pathology and MALDI-TOF mass spectrometry. Digital pathology is an image-based information environment that is enabled by computer technology to allow for the management of information generated from a digital slide. Digital pathology is enabled in part by virtual microscopy, which is the practice of converting glass slides into digital slides that can be viewed, managed, and analyzed on a computer monitor. With the advent of Whole-Slide Imaging, the field of digital pathology has exploded and is currently regarded as one of the most promising avenues of diagnostic medicine in order to achieve even better, faster and cheaper diagnosis, prognosis and prediction of cancer and other important diseases.
MALDI-TOF (matrix assisted laser desorption ionization-time of flight) mass spectrometry allows clinical laboratories to identify small aerobic gram-positive bacilli more accurately, faster, and in a more cost-effective manner than ever. It enables the analysis of biomolecules (biopolymers such as DNA, proteins, peptides and sugars) and large organic molecules (such as polymers, dendrimers and other macromolecules), which tend to be fragile and fragment when ionized by more conventional ionization methods.
Even as pathologists are working to develop more sensitive and accurate diagnostic tests for cancer, similar efforts are underway in radiology and imaging. In fact, one research team has developed a self-assembling nanoparticle that can adhere to cancer cells, thus making them visible in MRI scans and possibly eliminate the need for invasive tissue biopsies.
Researchers have developed a self-assembling nanoparticle that targets cancer cells and makes them visible on magnetic resonance imaging (MRI) scans. The new nanoparticle improves MRI scanning efficacy by “specifically seeking out receptors that are found in cancerous cells,” according to researchers. Were this development to become a reality, it has the potential to alter anatomic pathology’s role in diagnosing cancer.
A diagnostic test is any kind of medical test performed to aid in the diagnosis or detection of disease. For example, such a test may be used to confirm that a person is free from disease, or to fully diagnose a disease, including to sub-classify it regarding severity and susceptibility to treatment. Diagnostic tests help physicians make clinical decisions for patient care.
Some diagnostic tests are parts of a physical examination that require only simple tools in the hands of a skilled practitioner, and can be performed in an office environment. Some other tests require elaborate equipment used by medical technologists in clinical laboratories, or the use of a sterile operating theater environment.
Some tests require samples of tissue or body fluids to be sent off to a pathology lab for further analysis. Some simple chemical tests, such as urine pH, can be measured directly in the doctor’s office.
The validity of such test results produced in each laboratory is entirely dependent on the measures employed before, during, and after each assay. Consistency in the production of good results requires an overall program that includes quality assurance, quality control, and quality assessment.
Diagnostic tests can be classified into three categories: invasive, minimally invasive and non-invasive.
Every test that shows an association between test results and the target disease is potentially useful. If it is not on its own thought to be useful, then a combination of it with other test results and/or data can potentially lead to a post-test probability that is thought to be high enough to rule the diagnosis in or low enough to rule the diagnosis out.
Companion diagnostics have also been developed to preselect patients for specific treatments based on their own biology, where such targeted therapy may hold promise in personalized treatment of diseases such as cancer.
Growing acceptance of companion diagnostics is a trend with the potential to greatly increase the value that clinical pathology laboratory testing delivers to physicians, patients, and payers. It has become increasingly common for pharmaceutical companies to make agreements with in vitro diagnostics (IVD) manufacturers to develop a companion diagnostic test specifically for a therapeutic drug under development by that pharmaceutical company.
As most pathologists and clinical managers know, use of a companion diagnostic test is expected to add precision to the physician’s decision to prescribe therapeutic drugs.
An electronic health record (EHR) is a digital version of a patient’s paper chart. EHRs are real-time, patient-centered digital medical records that make information available instantly and securely to authorized users. While an EHR does contain the medical and treatment histories of patients, an EHR system is built to go beyond standard clinical data collected in a provider’s office and can be inclusive of a broader view of a patient’s care.
- Contain a patient’s medical history, diagnoses, medications, treatment plans, immunization dates, allergies, radiology images, and laboratory and test results
- Allow access to evidence-based tools that providers can use to make decisions about a patient’s care
- Automate and streamline provider workflow
One of the key features of an EHR is that health information can be created and managed by authorized providers in a digital format capable of being shared with other providers across more than one health care organization. EHRs are built to share information with other health care providers and organizations – such as clinical laboratories, specialists, medical imaging centers, pharmacies, emergency facilities, and school and workplace clinics – so they contain information from all clinicians involved in a patient’s care.
According to HealthIT.gov, “A greater and more seamless flow of information within a digital health care infrastructure, created by electronic health records (EHRs), encompasses and leverages digital progress and can transform the way care is delivered and compensated. With EHRs, information is available whenever and wherever it is needed.
“EHRs give providers reliable access to a patient’s complete health information. This comprehensive picture can help providers diagnose patients’ problems sooner.”
EHRs can reduce errors, improve patient safety, and support better patient outcomes because they don’t just contain or transmit information; they “compute” it, for example, cross-referencing prescribed medications, alerting physicians to patient allergies and so on.
The Health Information Technology for Economic and Clinical Health (HITECH) Act, a component of the American Recovery and Reinvestment Act of 2009, represents the nation’s first substantial commitment of federal resources to support the widespread adoption of EHRs. This legislation includes incentives to encourage use of EHRs and other health information technology, based on a concept called “Meaningful Use.”
Meaningful Use requires the use of an EHR as well as a demonstration that it is used to meet objective and measurable requirements. It also includes the standardization of data formats, a requirement that patients are able to easily access and download their digital medical records and images for their own use, expansion of the scope of quality metrics tracking to include specialists and to reflect outcomes, as well as care coordination.
Additional criteria will focus on the sustainability of the program through improvements in quality, safety and efficiency that improve health outcomes.
Elizabeth Holmes is the convicted former CEO at Theranos, a now-defunct blood test company.
Holmes was a charming and charismatic leader, poised to change the world of clinical laboratory testing. Her legacy, however, will instead be one of enamoring well-recognized investors with her personality while the technology behind her company ultimately proved lacking.
Her downfall was stunning. In 2014, Holmes was reported to have 18 U.S. patents and 66 non-U.S. patents in her name, and she was listed as a co-inventor on more than 100 patent applications. She was the youngest self-made female billionaire on the 2014 Forbes 400 list, with an estimated net worth of $4.6 billion. Yet by early 2016, Forbes updated her net worth to zero.
She founded Theranos in 2003 at age 19 while she was a chemical engineering major at Stanford University. She subsequently dropped out of Stanford as a sophomore to focus on her startup.
Theranos’ technology was based on her invention and patent for a way to run 30 common clinical laboratory tests on blood obtained via a fingerstick using microfluidics technology – a much faster and cheaper method than traditional lab testing techniques.
By 2014, the company offered 200 tests, was licensed to operate in every state in the U.S., and was valued at nearly $10 billion.
While some observers predicted Holmes’s innovations would dominate the clinical lab test market, an in-depth investigative report by The Wall Street Journal in October 2015 revealed aspects of Theranos that the secretive company has kept from public view. This reporting started the chain of events that would lead to Theranos’s downfall.
As a result of regulator scrutiny, in July 2016, the Medicare program handed down stringent sanctions to Theranos for problems at the company’s lab, including a two-year prohibition on Holmes owning any CLIA-certified laboratory.
Then, in March 2018, the U.S. Security and Exchange Commission (SEC) filed charges that focused on Theranos and Holmes allegedly raising more than $700 million from investors by exaggerating or making false statements about the company’s technology and financial performance.
To settle the SEC’s charges, Holmes agreed to pay a $500,000 fine and surrender almost 19 million shares of Theranos stock and voting control of the company, the SEC said. Also, she was barred from running a public company for 10 years. At the time, Holmes did not admit to nor deny the charges.
Later in 2018, the federal prosecutors charged Holmes on various counts of conspiracy and wire fraud charges. Following the indictments, Holmes stepped down as CEO. Theranos dissolved in September 2018.
Holmes went on trial in fall 2021 after multiple delays due to the COVID-19 pandemic and her pregnancy. On January 3, 2022, she was found guilty on three counts of defrauding investors and one count of wire fraud. She is scheduled to be sentenced in September 2022.
Esoteric testing allows the analysis of rare substances or molecules that are not performed in a routine clinical lab. Many large commercial lab companies outsource complex tests to reference and esoteric testing labs. However, as technology continues to expand laboratory testing, tests that are considered esoteric today may become routine in just a few years. This is often the result of work performed by dedicated research and development scientists.
These tests are ordered when a physician requires additional detailed information, outside routine lab testing, to complete a diagnosis, establish a prognosis or choose and monitor a therapeutic regimen. Esoteric testing generally requires sophisticated instruments and materials as well as specialized personnel to perform and analyze results. The tests are typically outsourced to independent, specialized clinical reference laboratories because it is not cost effective for hospitals and physician office laboratories to perform the tests in-house.
These tests are ordered less frequently than routine tests and are generally priced higher than the routine tests. Esoteric testing is typically related to the medical fields such as endocrinology, genetics, immunology, microbiology, molecular diagnostics, oncology, serology and toxicology. Molecular diagnostics is the fastest growing segment of esoteric clinical testing.
The American Chemical Society publishes the Directory of Rare Analyses (DORA) which catalogues rarely ordered clinical tests and provides details on the labs performing them.
The challenges for labs performing such tests include not only finding qualified medical technologists, but also paying them the higher salaries they command because of the scarcity of their skill sets. In addition, materials used in these tests can also be costly, particularly because they are not usually purchased in large enough quantities to qualify for economies of scale.
Labs that perform these tests have capabilities including:
• Complex anatomic pathology with board-certified pathologist
• Bone markers
• Genetic analysis
• HLA testing
• Functional assays of the immune system
In the U.S., labs that perform these tests range from ARUP Laboratories, Mayo Medical Laboratories, Quest Diagnostics Incorporated, and Laboratory Corporation of America to a growing number of specialty esoteric testing laboratories that offer proprietary esoteric assays. Examples of such specialty testing lab companies include Myriad Genetics, Genomic Health, and Foundation Medicine.
An Emergency Use Authorization (EUA) in the United States is an authority granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA).
The Emergency Use Authorization (EUA) authority allows the FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies.
During the COVID-19 pandemic, the FDA has issued many EUAs for tests as well as treatments, including convalescent plasma.
Fee-for-service has long been the primary payment model for clinical laboratories and pathology groups. Fee-for-service (FFS) is a payment model in which services are paid for as itemized in the provider’s invoice. It gives an incentive for physicians to provide more treatments because payment is dependent on the quantity of care, rather than quality of care. Similarly, patients are incentivized to welcome any medical service that might not be necessary. Insurance companies shield themselves against ruin by setting cover limits for every beneficiary.
FFS raises costs, discourages the efficiencies of integrated care, and a variety of reform efforts have been attempted, recommended, or initiated to reduce its influence (such as moving towards bundled payments and capitation).
Medicare Parts A (hospital insurance) and B (optional insurance that covers physician, outpatient hospital, home health, laboratory tests, durable medical equipment, designated therapy, outpatient prescription drugs, and other services not covered by Part A) are FFS programs. Medicare processes over one billion FFS claims per year.
As part of the ongoing drive to cut healthcare costs, this model is gradually being phased out by payers and healthcare organizations in favor of value-based payment models, such as pay-for-performance programs and accountable care organizations that are intended to cap costs and spread financial risk among providers, while encouraging coordination of care, disease prevention and better management of chronic conditions. This is seen as a threat to the survival of clinical labs, which expect to see far fewer tests ordered by healthcare providers.
The Clinical Laboratory Management Association is working to help labs navigate these changes. “As fee-for-service reimbursement gives way to bundled reimbursement and per-member-per-month payment, labs will only be successful if they add value to physicians by helping them diagnose disease earlier and more accurately,” says CLMA President Paul Epner.
CLMA has named this program “Increasing Clinical Effectiveness,” or ICE. THE DARK REPORT is one of CLMA’s partners in this effort.
“Our hope is that ICE is a catalyst that helps lab administrators, pathologists, and medical laboratory scientists broaden the focus of their laboratory beyond operational efficiency to include measurable impact on positive patient outcomes,” says Epner.
The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
In June 1906, President Theodore Roosevelt signed into law the Food and Drug Act. The Act prohibited, under penalty of seizure of goods, the interstate transport of food that had been “adulterated.”
The responsibility for examining food and drugs for such “adulteration” or “misbranding” was given to the USDA Bureau of Chemistry. In 1927, the Bureau of Chemistry’s regulatory powers were reorganized under a new USDA body, the Food, Drug, and Insecticide organization. This name was shortened to the Food and Drug Administration (FDA) three years later.
The FDA was empowered by the United States Congress to enforce the Federal Food, Drug, and Cosmetic Act, which serves as the primary focus for the Agency; the FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs.
The FDA is most popularly known for its work in regulating the development of new drugs. Its powers related to clinical laboratories include the Clinical Laboratory Improvement Amendments (CLIA) that regulate laboratory testing and require clinical laboratories to be certificated by their state as well as the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing. Laboratories can obtain multiple types of CLIA certificates, based on the kinds of diagnostic tests they conduct.
The agency also has the authority to issue pre-market clearance of laboratory-developed tests (LDTs) for in vitro diagnostic instrument systems and IVD test kits that a laboratory wishes to sell to other labs. More recently, FDA has decided to launch the regulation of all LDTs, including pre-market review for higher-risk LDTs.
The trend in healthcare and in clinical diagnostics is toward adoption of health information technology (HIT). The Health Information Technology for Economic and Clinical Health Act (HITECH) of 2009, the Affordable Care Act (ACA), and other government regulations were all designed with components that provide incentives for doctors, hospitals, laboratories, and other healthcare providers to adopt the use of electronic medical records (EMR), electronic health records (EHR), laboratory information management systems (LIMS), and other forms of HIT.
There appear to be three major trends in HIT when it comes generally to medical data and specifically to laboratory test data. They are direct patient access, web access and mobile device access.
Another factor in the adoption of HIT is “meaningful use” (MU) guidelines. When incentives were established to get healthcare providers to adopt HIT, part of the definition involved that they adopt “meaningful use” (MU) of HIT. Meaningful Use has several different stages with varying standards adopters have to meet in order to receive the financial incentives or to avoid any penalties. Stage 1 of MU has numerous steps to it, but of significance in terms of adoption trends is the requirement for eligible professionals to “provide more than 10% of all unique patients with timely electronic access to their health information.”
Access must be through a secure channel that encrypts and protects the content. Furthermore, the patient’s information must be available within four business days for EPs and within 36 hours of discharge in hospital settings. Fifty percent of patients must have access with 5% actually viewing, downloading or transmitting to meet the Stage 2 measure.
The demand for HIT has put laboratories on the front lines in adopting laboratory information management systems that can connect with electronic health records either directly or through portals. Although this can place a financial strain on small- to medium-sized laboratories, a number of companies are offering low- cost, customizable modular systems or Web-based services that can expand their current LIMS capabilities into new areas, including to patient portals.
The technical requirements of these modules or web-based portals or services are compliance with CLIA, HIPAA, and HL7 standards, provisions to ensure the privacy and security of personal health information, and the ability to be viewed by a variety of browsers and devices, including mobile applications.
Histology is a branch of anatomy that deals with the study structure of animal and plant tissues that is only discernible with a microscope. It is also called microscopic anatomy, as opposed to gross anatomy, which involves structures that can be observed with the naked eye. The word “histology” is derived from two Greek words: histo, which means “tissue,” and logos, which means “study.”
Histopathology, the microscopic study of diseased tissue, is an important tool used in anatomical pathology, as accurate diagnosis of cancer and other diseases usually requires histopathological examination of samples.
Histological studies are often carried out by examining a thin slice (called a “section”) of tissue under a light microscope or an electron microscope on a prepared slide.
In order to distinguish different biological structures more easily and accurately, histological stains are often used to add colors to, or enhance the colors of, certain types of biological structures to allow them to be more easily differentiated from other types of structures. Staining is employed because biological tissue has little inherent contrast when observed using either light or electron microscopes.
Trained physicians, frequently licensed clinical pathologists, are the personnel who actually perform histopathological examinations and provide diagnostic information based on their observations of the tissues being tested.
The trained personnel who prepare histological specimens for examination may go by a number of titles, including:
- Histology technician (HT)
- Histology technologists (HTL)
- Medical scientists
- Medical laboratory technician
- Biomedical scientist
Their field of study is called histotechnology.
Histology has seen recent changes as technological advances in automation have influenced the field. Automation allows for the reduction of the workload of manual task needed to prepare and track histology specimens. Artificial intelligence also is playing a growing role in supporting the analysis of sections, supporting anatomic pathologists during their examinations of samples.
The International Classification of Diseases (ICD) set code is the international standard diagnostic tool for epidemiology, health management and clinical purposes. ICD codes are maintained by the World Health Organization, the directing and coordinating authority for health within the United Nations System.
The most current version is ICD-10, which replaced ICD-9 on Oct. 15, 2015.
ICD-10 was originally issued in 1992 by the WHO. It has been adopted by most developed nations. Thus, the United States is one of the last developed nations to adopt ICD-10.
ICD-11 is scheduled to be released during 2018. A beta version of ICD-11 has been available online since 2012. Countries around the world that have used ICD-10 for more than two decades are expected to move expeditiously to adopt ICD-11.
The ICD is designed as a health care classification system, providing a system of diagnostic codes for classifying diseases, including nuanced classifications of a wide variety of signs, symptoms, abnormal findings, complaints, social circumstances, and external causes of injury or disease.
ICD codes are used by clinical laboratories for billing purposes, and by physicians, nurses, other providers, researchers, health information managers and coders, health information technology workers, policy-makers, insurers and patient organizations to classify diseases and other health problems recorded on many types of health and vital records, including death certificates and health records.
In addition to enabling the storage and retrieval of diagnostic information for clinical, epidemiological and quality purposes, these records also provide the basis for the compilation of national mortality and morbidity statistics by WHO Member States. Finally, ICD is used for reimbursement and resource allocation decision-making by countries.
Clinical laboratories and pathology groups have a big stake in successful transition to ICD-10. Medicare Part B claims for medical laboratory tests must be submitted with an appropriate ICD code provided by the physicians who ordered the lab tests. Lab test claims without an appropriate ICD code will not be reimbursed by the Medicare program.
In vitro diagnostics (IVDs) are diagnostic tests that that can detect diseases, conditions, or infections. In vitro diagnostics test a sample of tissue or bodily fluids, as opposed to testing inside the body, such as:
- Microbiological culture, which determines the presence or absence of microbes in a sample from the body, usually targeted at detecting pathogenic bacteria
- Genetic testing
- Blood glucose
- Liver function tests
Electrolytes in the blood, such as sodium, potassium, creatinine and urea.
In vitro tests can be classified according to the location of the sample being tested, including blood and urine tests.
Some tests are used health professional settings such as clinical laboratories, and other tests are for consumers to use at home. The expression “in vitro” comes from Latin, literally meaning “within the glass.” The name reflects the fact that historically such tests were conducted in glass vessels, such as test tubes.
Unlike other forms of medical technology, IVDs never interact directly with the human body. Their value stems from the information they provide. This sets IVDs apart from medical devices and pharmaceuticals, and is part of what makes them unique among health technologies.
In the U.S., in vitro diagnostics products are medical devices as defined in section 210(h) of the Federal Food, Drug, and Cosmetic Act, and may also be biological products subject to section 351 of the Public Health Service Act. Like other medical devices, IVDs are subject to premarket and postmarket controls. IVDs are also subject to the Clinical Laboratory Improvement Amendments (CLIA ’88) of 1988.
The IVD industry is growing steadily due to a number factors, such as increased demand for infectious disease testing as new pathogen strains develop each year, such as in seasonal influenza and H1N1, and increased incidences of hospital-acquired infections. Other factors include aging demographics common to all developed nations and the accompanying increased incidence of chronic disease across all age cohorts of the population; advances in DNA sequencing; and growing demand from emerging markets, which are only now becoming able to pay for diagnostic devices.
ISO 15189 (Medical laboratories — Particular requirements for quality and competence) specifies the quality management system requirements particular to medical laboratories. The standard was developed by the International Organisation for Standardizations’s Technical Committee 212 (ISO/TC 212).
ISO 15189 focuses on the continuum of care directly connected with improved patient safety, risk mitigation and operational efficiency.
The International Organization for Standardization has released three versions of the standard. The first two were released in 2003 and 2007. In 2012, the organization released a revised and updated version of the standard, ISO 15189: 2012 (Medical laboratories – Requirements for quality and competence). The standard is often referred to without the version, simply as “ISO 15189.”
ISO/TC 212 assigned ISO 15189 to a working group to prepare the standard based on the details of ISO/IEC 17025:1999 General requirements for the competence of testing and calibration laboratories. This working group included provision of advice to users of the laboratory service, the collection of patient samples, the interpretation of test results, acceptable turnaround times, how testing is to be provided in a medical emergency and the lab’s role in the education and training of health care staff.
While the standard is based on ISO/IEC 17025 and ISO 9001, it is a unique document that takes into consideration the specific requirements of the medical environment and the importance of the clinical laboratory to patient care.
ISO 15189 can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.
Software solutions designed specifically for medical laboratories can aid in achieving ISO 15189 accreditation. In particular, document control software can help by improving turnaround time (TAT) for document reviews, increasing efficiency of staff and improving overall quality.
ISO 15189 is one of the fastest growing international quality standards in the world. Twenty-three countries around the world adopted the standard within a year of publication, and by 2013, the standard was adopted by medical laboratories in over 60 countries.
ISO 15189 accreditation is the gateway to the effective use of the quality management system (QMS) that is an integral part of all ISO standards. These standards range from the basic ISO 9001 to ISO 15189–Medical Laboratories and ISO 17025–Competence of Testing and Calibration Laboratories.
ISO 15189 specifies the quality management system requirements particular to medical laboratories. ISO 15189 is one of the fastest growing international quality standards in the world.
Clinical laboratories and pathology groups experience many benefits by achieving ISO 15189 accreditation. Use of quality management systems by innovative clinical laboratories and pathology groups enables them to drive impressive gains in quality, customer satisfaction, and financial performance. This is a key development at a time when medical laboratory budgets are shrinking and more cuts in lab test prices are expected.
As explained by MedLab, ISO 15189 accreditation also reduces risks, encourages the sharing of best practices and stimulates innovation. For payers and healthcare providers, accreditation is a tool that provides assurance that clinical lab services are safe, reliable and good value for patients. It also provides a mechanism for measuring quality improvements and supporting consistency.
For patients, accreditation gives confidence that the services they receive are competent and safe, which can be a significant selling point for a medical laboratory.
One of the main benefits of ISO 15189 accreditation is that it is globally recognized. A series of Mulitlateral Mutual Recognition Arrangements within the International Laboratory Accreditation Cooperation (ILAC) means that laboratories accredited to ISO 15189 will have their certificates and test reports accepted in over 80 different economies across the world, representing 95% of global GDP.
The accreditation to ISO 15189 is in addition to CLIA ‘88 accreditation and does not replace it.
Anyone can self‐declare competence in offering ISO 15189 accreditations. However, organizations such as the American Association of Laboratory Accreditation (A2LA), the College of American Pathologists (CAP) are among the leading accreditors for ISO 15189 in the U.S.
Accreditation is also done by the Joint Commission, College of American Pathologists, AAB (American Association of Bioanalysts), and other state and federal agencies.
A2LA offers accreditation to clinical testing laboratories in 34 specialties and subspecialties. A2LA is also the only accreditor in the United States that is recognized internationally.
The CAP says it is the largest and most experienced accreditor in the world in the specialty of medical laboratory accreditation, leading and enhancing laboratory accreditation for more than 50 years. Pathologists from CAP have been instrumental in crafting the ISO 15189 standard.
The laboratory benefit management program is a controversial program created by UnitedHealthcare in 2014, which “is designed to help improve quality of care and manage appropriate utilization for outpatient laboratory services,” according to UHC.
The pilot launch was for laboratory services ordered by Florida network providers for fully insured UnitedHealthcare Commercial members in Florida, excluding Neighborhood Health Partnership.
All outpatient laboratory services for members who are part of the Laboratory Benefit Management Program are subject to new requirements including advance notification and new medical policies.
Beacon Laboratory Benefit Solutions, Inc. (BeaconLBS®), which specializes in laboratory services management, administers the Laboratory Benefit Management Program for UHC.
Under the program, physicians serving UHC’s commercial patients in Florida must notify UHC when ordering any of 80 clinical laboratory tests. Pre-authorization is also required for certain tests.
The program has generated widespread resistance from Florida physicians, who protest that it will cause unnecessary delays for patient treatment, and undue burdens for doctors ordering tests. In addition to problems with lab test pre-notification algorithms within the BeaconLBS system, other problems cited by physicians include the exclusion of all but 13 Florida labs from the BeaconLBS “laboratory of choice network.”
Physicians claimed that this disrupts longstanding clinical relationships between physicians and their preferred labs. It also means that patients who have been served for years by their physicians’ preferred labs must now visit one of the 13 labs in the BeaconLBS network.
Pathologists are particularly concerned that BeaconLBS requires them to get a second review when ordering certain tests and to ensure that subspecialist pathologists who review tests have specific certifications, according to the College of American Pathologists. After CAP asked UHC to reconsider these two requirements, UHC left these requirements in place.
UHC is Florida’s second largest health insurer with approximately a 14% share of the market.
A laboratory developed test (LDT) is a type of in vitro diagnostic (IVD) procedure that an individual lab develops for its own use only.
In academic medical center laboratories, these proprietary clinical laboratory tests often are created to address an unmet clinical need.
Currently, LDTs are regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). They are generally not reviewed by the Food and Drug Administration (FDA), although proposed legislation before Congress seeks to change that arrangement.
LDTs can only be offered and used by a single clinical laboratory; otherwise, they require FDA authorization before they can be manufactured or used outside of the lab they were developed in.
LDTs have played an important role in promoting the rapid development of new testing technologies. There has, however, been concern expressed by the FDA that the lack of oversight for these tests causes patients to get unnecessary treatments.
These tests played an important role in the early response to the SARS-CoV-2 pandemic. Many COVID-19 tests started as LDTs that then obtained Emergency Use Authorization (EUA) from the FDA.
The FDA has argued that due to advances in technology and business models, LDTs have evolved and proliferated significantly since the FDA first obtained authority to regulate all in vitro diagnostics in 1976. Some LDTs are now more complex, have a nationwide reach, and present higher risks, such as detection of risk for breast cancer and Alzheimer’s disease. In such cases, LDTs are similar to other IVDs that have undergone pre-market review.
In 2010, the FDA announced its intention to reconsider its policy of enforcement for LDTs. Four years later, the agency notified Congress of its intent to issue a draft oversight framework for LDTs based on risk to patients rather than whether they were made by a conventional manufacturer or a single laboratory. This draft oversight framework included pre-market review for higher-risk LDTs, like those used to guide treatment decisions, including the many companion diagnostics that have entered the market as LDTs. In addition, under the draft framework, the FDA would continue to exercise enforcement discretion for low-risk LDTs and LDTs for rare diseases, among others.
Those statements set the stage for more recent developments in how LDTs are regulated. In 2021, the Verifying Accurate Leading-Edge IVCT Development Act (VALID Act) was proposed by a bipartisan group of lawmakers. If the VALID Act becomes law, the FDA will have clear authority to regulate LDTs and generally will require these tests to have FDA approval before being marketed or used. CLIA’s influence over LDTs would wane under the VALID Act.
A substantial portion of laboratory leaders and pathologists believe that passing the VALID Act will stifle innovation in the field of clinical lab testing due to the costs and resources associated with FDA review. Proponents of the VALID Act argue that FDA pre-market approval is needed for all IVD tests because they are similar to medical devices and thus require extensive data collection.
As of August 2022, the VALID Act had been appended to a larger Senate bill that focused on FDA user fees. A vote is still pending on the larger bill. The House version of the VALID Act remained an ind
A laboratory information management system (LIMS) is a computer program or information management system designed to handle the workflow and data tracking of laboratory information. Although there are subtle differences within the industry, the term LIMS is often used interchangeably with laboratory information system (LIS). For many years the clinical diagnostic lab—and healthcare in general— depended upon paper orders and requisitions and results reporting.
In February 2014 the Department of Health and Human Services (HHS) issued an amendment to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) known as the “Final Rule” that significantly increases patient access and empowerment. The Final Rule gives patients (or their authorized representative) the right to access test reports directly from a laboratory without first receiving authorization from a healthcare provider. It does not require laboratories to interpret test results, just to provide them.
Moreover, the Final Rule eliminates an exception under HIPAA that exempted CLIA-certified or CLIA-exempt laboratories from providing individuals access to their own health information.
Under the Final Rule, patients can still receive test reports from their doctors if they choose, but now they have the option to obtain results from the laboratory. Surveys indicate that the vast majority of patients want that access. The burden of providing it and providing it in a way that is meaningful and reliable, is on the shoulders of the healthcare industry and the clinical laboratories.
A modern LIMS has numerous components, including computerized provider order entry (CPOE), rules-making ability, barcoding, direct interfaces with laboratory instrumentation and the LIMS, EMR, EHRs, patient portals, and potential for adding rich content and patient-oriented data interpretation.
With over a quarter-million different laboratories, numerous different lab types, and the multiple complicated connections a LIMS needs to make between physicians, hospitals, clinics, insurers, and patients, connectivity and standardization is not a simple matter.
The federal government in general, and specifically through legislation such as the Patient Protection and Affordable Care Act (ACA) and the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009, have provided incentives and penalties for all healthcare providers, including laboratories, to adopt electronic health information technology (HIT) that is interoperable and accessible.
A quality management system (QMS), as required by ISO 15189:2012, is a compilation of organizational documents that establishes the policies and procedures needed to direct and control an organization with regard to quality. It relates to general management activities, the provision and management of resources, the pre‐examination, examination and post‐examination processes and evaluation and continual improvement.
A QMS captures the requirements of an organization and structurally provides a roadmap that explains who, what, when, where and how sustainable and repeatable outcomes will be achieved.
A quality management system consists of policies, procedures, SOPs and records, all of which provide proof of goals, assign responsibility, describe how those responsibilities are be performed and provide evidence of past accounts or occurrences of compliance.
It is a system by which an organization aims to reduce and eventually eliminate nonconformance to specifications, standards, and customer expectations in the most cost effective and efficient manner.
Use of quality management systems by innovative clinical laboratories and pathology groups enables them to drive impressive gains in quality, customer satisfaction, and financial performance. This is a key development at a time when medical laboratory budgets are shrinking and more cuts in lab test prices are expected.
On all fronts of laboratory medicine, requirements are becoming more stringent. Each year, labs find themselves held to higher standards for compliance with both Clinical Laboratory Improvement Act (CLIA) requirements and Medicare accreditation guidelines. This situation will become further complicated as clinical labs face the need to also meet the requirements of accountable care organizations (ACOs) and similar models of integrated clinical care. Early adopters are responding to these marketplace dynamics by making strategic use of a QMS to boost the performance of their clinical laboratory organizations. As they do, they often gain a competitive advantage.
When the federal government signed into law the Health Information Technology for Economic and Clinical Health (“HITECH”) Act as part of ARRA, which was, in part, designed to create incentives for the use of health information technology, it based many of the incentives on “Meaningful Use.”
The requirements are intended to progress through three different stages over several years.
Stage 1, Meaningful Use: Sets a baseline for electronic data capture and medical information sharing. Requires the use of an electronic health record (EHR) as well as a demonstration that it is used to meet objective and measurable requirements. There are 15 required core objectives and a menu of other objectives, several of which must be met in order to meet the thresholds of quality measurements in order to receive the financial incentives referenced in the regulations promulgated by the HITECH Act. For the most part these were implemented in 2011 through 2013.
Stage 2, Meaningful Use: Stage 2 focuses on “increasing the electronic capture of health information in a structured format, as well as increasing the exchange of clinically relevant information between providers of care at care transitions.”
Stage 2 set forth three broad requirements. First was the standardization of data formats, which is intended to simplify how healthcare information is captured and shared across disparate IT systems, i.e., improved interoperability.
Second, it required that patients are able to easily access and download their digital medical records and images for their own use.
Third, it expanded the scope of quality metrics tracking to include specialists and to reflect outcomes, as well as care coordination.
As part of Stage 2, healthcare entities must satisfy a lengthy list of measure criteria.
Stage 3, Meaningful Use: Stage 3 requirements were released in 2015. These criteria focus on the sustainability of the program through improvements in quality, safety and efficiency that improve health outcomes, and include:
- 8 objectives for eligible professionals, eligible hospitals, and CAHs: In Stage 3, more than 60 percent of the proposed measures require interoperability, up from 33 percent in Stage 2
- Public health reporting with flexible options for measure selection
- Meaningful Use clinical quality measures reporting aligned with the CMS quality reporting programs
- Finalize the use of application program interfaces (APIs) that enable the development of new functionalities to build bridges across systems and provide increased data access. This will help patients have unprecedented access to their own health records, empowering individuals to make key health decisions.
Medical imaging is the technique and process of creating visual representations of the interior of a body for clinical analysis and medical intervention. It seeks to reveal internal structures hidden by the skin and bones, as well as to diagnose and treat disease. It also establishes a database of normal anatomy and physiology to make it possible to identify abnormalities. Although imaging of removed organs and tissues can be performed for medical reasons, such procedures are usually considered part of pathology instead of medical imaging.
As a discipline and in its widest sense, it is part of biological imaging and incorporates radiology which uses the imaging technologies of X-ray radiography, magnetic resonance imaging, medical ultrasonography or ultrasound, endoscopy, elastography, tactile imaging, thermography, medical photography and nuclear medicine functional imaging techniques as positron emission tomography.
The type of imaging used depends on symptoms and the part of the body being examined. They include:
- CT scans
- Nuclear medicine scans
- MRI scans
In the clinical context, “invisible light” imaging is generally equated to radiology or “clinical imaging,” and the medical practitioner responsible for interpreting (and sometimes acquiring) the images is a radiologist. “Visible light” imaging involves digital video or still pictures that can be seen without special equipment. Dermatology and wound care are two modalities that use visible light imagery.
Diagnostic radiography designates the technical aspects of medical imaging and in particular the acquisition of medical images. The radiographer or radiologic technologist is usually responsible for acquiring medical images of diagnostic quality, although some radiological interventions are performed by radiologists. While radiology is an evaluation of anatomy, nuclear medicine provides functional assessment.
According to the New England Journal of Medicine, medical imaging is one of the top development in diagnostic technology that “changed the face of clinical medicine” during the last millennium. Today, imaging and radiation therapy are cornerstones of quality care.
Medical imaging can be performed in hospitals or in independent community clinical laboratories or medical imaging centers.
A medical laboratory or clinical laboratory is a laboratory where tests are done on clinical specimens in order to get information about the health of a patient as pertaining to the diagnosis, treatment, and prevention of disease.
Distribution of clinical laboratories in health institutions varies greatly from one place to another.
The staff of medical laboratories may include:
- Clinical biochemist
- Pathologist’s assistant (PA)
- Medical laboratory scientist (MT, MLS or CLS)
- Medical laboratory technician (MLT)
- Medical laboratory assistant (MLA)
- Phlebotomist (PBT)
In many countries, there are two main types of labs that process the majority of medical specimens. Hospital laboratories are attached to a hospital, and perform tests on patients. Private (or community) laboratories receive samples from general practitioners, insurance companies, clinical research sites and other health clinics for analysis.
These can also be called reference laboratories where more unusual and obscure tests are performed. These include Mayo Medical Laboratories, ARUP Laboratories, Quest Diagnostics and LabCorp. For extremely specialized tests, samples may go to a research laboratory. Many samples are sent between different labs for uncommon tests. It is more cost effective if a particular laboratory specializes in a rare test, receiving specimens (and money) from other labs, while sending away tests it cannot perform.
Laboratories today are held together by a system of software programs and computers that exchange data about patients, test requests, and test results known as a laboratory information system or LIS. The LIS is interfaced with the hospital information system.
This system enables hospitals and labs to order the correct test requests for each patient, keep track of individual patient or specimen histories, and help guarantee a better quality of results as well as printing hard copies of the results for patient charts and doctors to check.
Credibility of medical laboratories is paramount to the health and safety of the patients relying on the testing services provided by these labs. The international standard in use today for the accreditation of medical laboratories is ISO 15189. In the United States, under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), accreditation of medical laboratories is done by the Joint Commission, College of American Pathologists, AAB (American Association of Bioanalysts), and other state and federal agencies. CLIA 88 or the Clinical Laboratory Improvement Amendments also dictate testing and personnel.
A medical laboratory scientist (MLS) (also referred to as a medical technologist, a clinical scientist, or clinical laboratory technologist) is a healthcare professional who performs chemical, hematological, immunologic, microscopic, and bacteriological diagnostic analyses on body fluids such as blood, urine, sputum, stool, cerebrospinal fluid (CSF), peritoneal fluid, pericardial fluid, and synovial fluid, as well as other specimens. Medical laboratory scientists work in clinical laboratories as well as hospitals, physician’s offices, reference labs, biotechnology labs and non-clinical industrial labs.
In the United States, a medical laboratory scientist (MLS), medical technologist (MT) or clinical laboratory scientist (CLS, California only) typically earns a bachelor’s degree in clinical laboratory science, biomedical science, medical technology or in a life / biological science (biology, biochemistry, microbiology, etc.), in which case certification from an accredited training program is also required. Medical technologists who are certified and in good standing by a number of certification bodies, including the National Medical Laboratory Science Council or the American Society for Clinical Pathology (ASCP) are entitled to use the credential “MLS” after their names.
Subspecialties also requiring a four-year degree include cytotechnologists, who study cells and cellular anomalies, and histotechnologists, who work on the detection of tissue abnormalities and the treatment for the diseases causing the abnormalities.
In addition, there are also medical laboratory technicians (MLTs) who earn two-year degrees plus certification.
In the United States, the Clinical Laboratory Improvement Amendments (CLIA ’88) define the level of qualification required to perform tests of various complexity. Clinical laboratory scientists, medical technologists and medical laboratory scientists are the highest level of qualification, and are generally qualified to perform the most complex clinical testing including HLA testing (also known as tissue typing) and blood type reference testing.
Most medical technologists are generalists, skilled in all areas of the clinical laboratory. However some are specialists, qualified by unique undergraduate education or additional training to perform more complex analyses than usual within a specific field. Specialties include clinical biochemistry, hematology, coagulation, microbiology, bacteriology, toxicology, virology, parasitology, mycology, immunology, immunohematology (blood bank), histopathology, histocompatibility, cytopathology, genetics, cytogenetics, electron microscopy, and IVF labs.
Medical technologists with such a specialty may use additional credentials, such as “SBB” (Specialist in Blood Banking) from the American Association of Blood Banks, or “SH” (Specialist in Hematology) from the ASCP.
In the United States, Medical Laboratory Scientists can be certified and employed in infection control. These professionals monitor and report infectious disease findings to help limit iatrogenic and nosocomial infections. They may also educate other healthcare workers about such problems and ways to minimize them.
Medicare Part B medical insurance helps pay for some services and products not covered by Part A (hospital insurance) for Americans aged 65 and older who have worked and paid into the system. It also provides health insurance to younger people with disabilities.
Part B coverage begins once a patient meets his or her deductible ($147 in 2013), then typically Medicare covers 80% of approved services, while the remaining 20% is paid by the patient, either directly or indirectly by private Medigap insurance.
For clinical labs and pathology groups, Part B covers laboratory and diagnostic tests. Laboratory tests include certain blood tests, urinalysis, tests on tissue specimens, and some screening tests. They must be provided by a laboratory that meets Medicare requirements.
Complex rules are used to manage the benefit, and advisories are periodically issued which describe coverage criteria. On the national level these advisories are issued by CMS, and are known as National Coverage Determinations (NCD). Local Coverage Determinations (LCD) apply within the multi-state area managed by a specific regional Medicare Part B contractor, and Local Medical Review Policies (LMRP) were superseded by LCDs in 2003.
Medicare Part B payments make up about 15% of the revenue of the two biggest national lab companies. By contrast, it is common for community labs to have between 30% and 65% of their revenue come from Medicare Part B payments.
Part B coverage can also be provided by private insurers through Medicare Advantage Plans. Enrollment in private Medicare Advantage plans has more than doubled since 2006, according to the New York Times. As these plans gain popularity, clinical labs and pathology groups continue to find themselves without access to patients they once served. Medicare beneficiaries now enrolled in Advantage plans comprise nearly one-third of all Medicare beneficiaries.
Generally speaking, growth in Medicare Advantage enrollment favors the national labs, with private insurers providing them exclusive network contracts. This means less market access to these patients by community labs.
A nanotainer is the proprietary name for a tiny vial, less than half an inch tall, intended to hold a few drops of blood as part of the self-described “disruptive” blood testing technology invented by Theranos.
Theranos claimed that its proprietary technology allows it to run as many as 200 blood tests on just a couple of drops of blood, drawn via finger prick instead of a needle, that are contained in the Nanotainer.
However, when the federal Food and Drug Administration conducted unannounced inspections of Theranos facilities in August and September 2015, it reported that the nanotainer is a Class II Medical Device, for which manufacturers must use special labels, meet performance standards, and conduct post-market surveillance. FDA noted that Theranos was using the device without its clearance or approval.
Theranos argued that the nanotainer is a Class I device, for which there are no regulatory requirements However, the FDA documented a number of complaints from its inspections, including that a the Nanotainer had a design evaluation that didn’t ensure the device “conforms to defined user needs and intended uses.” Additionally, the nanotainer “was not validated under actual or simulated use conditions,” and the risk analysis for the device hasn’t been adequately documented. FDA also said there were inadequate procedures for logging customer complaints, and that complaints that Theranos’ technology didn’t work weren’t reviewed or investigated.
Theranos had become involved in legal proceedings in 2014 following objections filed to Theranos’ trademark application by Becton Dickinson, which holds a trademark for the name “Microtainer.”
Theranos responded by filing papers asking that the U.S. District Court for the Northern District of California rule that “nanotainer” does not infringe the “microtainer” trademark used by Becton Dickinson. The parties arbitrated and settled their dispute on Sept. 28, 2015 with apparently no money changing hands.
However, in October 2015, Theranos founder Elizabeth Holmes announced that the company was no longer using the nanotainer except for one FDA-cleared test, HSV-1, for which it earned FDA clearance in July. For more than 240 other blood tests, she said, Theranos was performing traditional venipunctures with test tubes and standard analysis technology.
As of late 2015, Theranos had released no data or peer-reviewed studies to prove its claims for the nanotainer or its blood analysis technology. After becoming the target of a major expose by the Wall Street Journal,, CMS sanctions and numerous lawsuits in 2016, the company announced that it was leaving the clinical lab business to focus on device development instead.
A pathology group is an organization of clinical pathologists working on the diagnosis of disease based on laboratory analysis of bodily fluids such as blood and urine, as well as tissues, using the tools of chemistry, clinical microbiology, hematology and molecular pathology. Clinical pathologists work in close collaboration with medical technologists, hospital administrations, and referring physicians.
The business model of a pathology group has traditionally been as a private group practice, including solo practitioner, medical group partnership, professional corporation (PC), limited liability company (LLC), and similar professional business organizations. It is common for pathology groups to have contracts with one or more hospitals to provide anatomic pathology professional services and clinical pathology professional services.
Pathology itself is a significant component of the causal study of disease and a major field in modern medicine and diagnosis. The term pathology may be used broadly to refer to the study of disease in general, incorporating a wide range of bioscience research fields and medical practices, or more narrowly to describe work within the contemporary medical field of “general pathology,” which includes a number of distinct but inter-related medical specialties which diagnose disease mostly through the analysis of tissue, cell, and body fluid samples.
Pathologists in hospital labs and pathology groups practice as consultant physicians, developing and applying knowledge of tissue and laboratory analyses to assist in the diagnosis and treatment of individual patients. As scientists, they use the tools of laboratory science in clinical studies, disease models, and other experimental systems, to advance the understanding and treatment of disease.
Clinical pathologists in a pathology group administer a number of visual and microscopic tests and an especially large variety of tests of the biophysical properties of tissue samples involving automated analyzers and cultures. Sometimes the general term “laboratory medicine specialist” is used to refer to those working in clinical pathology, including medical doctors, PhDs and doctors of pharmacology.
Immunopathology, the study of an organism’s immune response to infection, is sometimes considered to fall within the domain of clinical pathology.
Becoming a pathologist entails one of the lengthiest education and training tracks of all physicians. Requirements include four years of undergraduate study, plus four years of medical school, plus a minimum of four to five years of post-graduate training in pathology residency.
Personalized medicine or PM is a medical model that proposes the customization of healthcare, with medical decisions, practices, and/or products being tailored to the individual patient. In this model, diagnostic testing is often employed for selecting appropriate and optimal therapies based on the context of a patient’s genetic content or other molecular or cellular analysis.
The use of genetic information has played a major role in certain aspects of PM. and the term was first coined in the context of genetics, though it has since broadened to encompass all sorts of personalization measures.
Personalized medicine is not limited to pharmaceutical therapy. Advances in computational power and medical imaging are paving the way for personalized medical treatments that consider a patient’s genetic, anatomical and physiological characteristics.
Several terms, including “precision medicine,” “targeted medicine” and “pharmacogenomics” are sometimes used interchangeably with “personalized medicine.”
According to the FDA, the term is often described as providing ‘the right patient with the right drug at the right dose at the right time.’ More broadly, PM may be thought of as the tailoring of medical treatment to the individual characteristics, needs, and preferences of a patient during all stages of care, including prevention, diagnosis, treatment, and follow-up.
Advances in genetic and molecular knowledge about different diseases are widely expected to generate more opportunities for PM products and services. Clinical laboratories and pathology groups are continually developing new capabilities in molecular diagnostics, such as the analysis of DNA, RNA, and the human proteome.
Reimbursement policies will have to be redefined to fit the changes that PM will bring to the healthcare system. Some of the factors that will be considered are the level of efficacy of various genetic tests in the general population, cost-effectiveness relative to benefits, how to deal with payment systems for extremely rare conditions, and how to redefine the insurance concept of “shared risk” to incorporate the effect of the newer concept of “individual risk factors.”
Pharmacogenomics is the study of how genes affect a person’s response to drugs. This relatively new field combines pharmacology (the science of drugs) and genomics (the study of genes and their functions) to develop effective, safe medications and doses that will be tailored to a person’s genetic makeup. Medical professionals and administrators hope this will save lives while also enhancing the practice of personalized medicine, in which drugs and drug combinations are optimized for each individual’s unique genetic makeup.
Many drugs that are currently available are “one size fits all,” but they don’t work the same way for everyone. Whether used to explain a patient’s response or lack thereof to a treatment, or act as a predictive tool, personalized medicine hopes to achieve better treatment outcomes, greater efficacy, minimization of the occurrence of drug toxicities and adverse drug reactions (ADRs). Adverse drug reactions are a significant cause of hospitalizations and deaths in the United States.
With the knowledge gained from the Human Genome Project, researchers are learning how inherited differences in genes affect the body’s response to medications. These genetic differences will be used to predict whether a medication will be effective for a particular person and to help prevent adverse drug reactions.
The field of pharmacogenomics is still in its infancy. Its use is currently quite limited, but new approaches are under study in clinical trials. In the future, pharmacogenomics will allow the development of tailored drugs to treat a wide range of health problems, including cardiovascular disease, Alzheimer disease, cancer, HIV/AIDS, and asthma.
The term pharmacogenomics is often used interchangeably with pharmacogenetics. Although both terms relate to drug response based on genetic influences, pharmacogenetics focuses on single drug-gene interactions, while pharmacogenomics encompasses a more genome-wide association approach, incorporating genomics and epigenetics while dealing with the effects of multiple genes on drug response.
On April 1, 2014, President Barack Obama signed H.R. 4302: Protecting Access to Medicare Act (PAMA) of 2014. The law’s primary purpose was to extend the Sustainable Growth Rate (SGR) formula for 12 months.
Along with the SGR extension, PAMA addressed a grab bag of Medicare-related issues.
Under PAMA, many clinical laboratory organizations will see a substantial decline over the coming years in the prices paid to them for the highest-volume lab tests reimbursed under Medicare Part B. The law specifies that the federal Centers for Medicare & Medicaid Services (CMS) can begin enacting those price cuts in 2017.
Six aspects of PAMA specifically apply to clinical laboratories:
- Setting prices with market data: Certain labs are required, as of Jan. 1, 2016, to report private-payer payment rates and volumes for their tests.
- New category – Advanced diagnostics tests (ADTs): For certain tests developed and performed by single laboratories, the initial payment rate for ADTs will be set at the “actual list charge.” If the charge exceeds private-payer rates by more than 130%, CMS can recoup the overpayment.
- Setting prices for new tests and expert advisory panel: To ensure transparent and reliable decisions about pay rates and coverage, CMS will assemble a panel of outside advisors, including clinicians and other technical experts. Also, CMS must follow either the crosswalk or gapfill process to determine the initial payment rates and explain, in a transparent manner, how the calculations were made.
- Changes in how Medicare handles lab test codes: For new lab tests, CMS will use temporary HCPCS codes to enable payment prior to a permanent HCPCS or CPT code.
- Coverage requirements and decisions: In support of fair and open coverage decisions for a lab test when a local coverage determination is needed, MACs must now follow a defined development and appeals process.
- Oversight of the process to create coverage guidelines and set lab test prices: Two levels of oversight are written into the law: one by the U.S. Government Accountability Office (GAO), the other by the Office of Inspector General (OIG) of Department of Health and Human Services (DHHS).
An antibody or serology test is a blood test that looks for signs of a previous COVID-19 infection. It detects antibodies, which are proteins in the blood that fight off infection. Antibody testing has a lot of promise because it will help us understand the pervasiveness of COVID-19 in our communities.
A COVID-19 antibody test, also known as a serology test, is a blood test that can detect if a person has antibodies to SARS-CoV-2, the virus that causes COVID-19. COVID-19 antibody tests can help identify people who may have been infected with the SARS-CoV-2 virus or have recovered from the COVID-19 infection.
An antibody test can’t determine whether you’re currently infected with the COVID-19 virus.
Six Sigma, like Lean, is used to improve the quality and efficiency of operational processes. During the past decade, these process improvement techniques increasingly have been applied outside of the manufacturing sector, for example, in healthcare.
While Lean focuses on identifying ways to streamline processes and reduce waste, Six Sigma aims predominantly to make processes, such as those used in clinical laboratories and pathology group labs, more uniform and precise through the application of statistical methods.
Along with Lean, this process improvement technique has become popular with labs as a way to streamline laboratory processes, reduce costs, increase productivity, and improve quality in a time when labs are increasingly pressured by downward price trends for lab tests. At the same time, labs are able to increase value offered to “customers,” that is, patients.
The principles of a Six Sigma-based system were originally developed by Bill Smith of Motorola in 1986 as a way of eliminating defects in manufacturing, where a defect is understood to be a product or process that fails to meet customers’ expectations and requirements. The name refers to a quality level defined as the near-perfect defect rate of 3.4 defects per million opportunities. As a process improvement strategy, it gained much attention through its association with General Electric and its former CEO Jack Welsh.
Six Sigma also involves the training and certification of designated process specialists (called black belts, green belts, or other similar titles) within organizations to help guide Six Sigma improvement efforts. Other distinctive features include the expectation that process quality improvements be translated into financial metrics to assess value and the active involvement of top management in all initiatives.
Six Sigma is often combined with Lean management techniques to produce a methodology that relies on a collaborative team effort to improve performance by systematically removing waste (Lean) as well as defects, overproduction, waiting, non-utilized talent, transportation, inventory, motion and extra-processing (Six Sigma).
Theranos was a failed blood analysis company that became notorious for gaining a $10 billion valuation without actually having proven, functional technology.
Theranos was founded by entrepreneur Elizabeth Holmes. Its name is a combination of therapy and diagnosis. Holmes founded the company in 2003, dropping out of Stanford University as a sophomore to do so.
The company announced that it would leave the clinical laboratory business in 2016 after becoming the target of a major expose by the Wall Street Journal, CMS sanctions, and numerous lawsuits. Theranos was ultimately dissolved in 2018 by David Taylor, its CEO at the time.
Theranos claimed it could perform hundreds of laboratory tests using a finger-stick collection and a micro-specimen vial instead of a needle and several vacutainers of blood. The company said it could return results in four hours for about half of the typical Medicare Part B lab test fees. This would have been exponentially less painful, faster, and cheaper than conventional blood testing performed by clinical laboratories. Theranos partnered with Walgreens in late 2013, with 41 Walgreens testing centers participating in this partnership at one point.
Theranos problems began with an in-depth investigative report by The Wall Street Journal in October 2015. This report was the result of information provided by whistleblowers whose concerns were ignored by both Holmes and Theranos’s President and Chief Operating Officer, Ramesh “Sunny” Balwani.
The Journal’s report revealed aspects of Theranos that the secretive company had kept from public view. Based on interviews with several employees and others with knowledge of events at Theranos, the Journal disclosed that the company ran only a handful of tests using its proprietary technology, relying on traditional testing for most of its specimen work. Following this exposé, Theranos quickly lost its role as the darling of the media and Silicon Valley.
In July 2016, the U.S. Centers for Medicare and Medicaid Services applied the most stringent sanctions it could to Theranos for problems it reported at the company’s lab in Newark, Calif., including a two-year prohibition on Holmes owning any CLIA-certified lab.
As a result of in-depth investigations, the U.S. Security and Exchange Commission (SEC) filed charges on March 14, 2018, stating that Theranos, Holmes, and Balwani allegedly raised more than $700 million from investors through an elaborate, years-long scheme that involved exaggerating or making false statements about the company’s technology, business, and financial performance.
To settle the SEC’s charges, Holmes agreed to pay a $500,000 fine and to surrender almost 19 million shares of Theranos stock and voting control of the company, the SEC said. Also, she was barred from running a public company for 10 years. At the time, Holmes did not admit to nor deny the charges. Balwani said he would contest the charges.
Three months later, the federal U.S. Department of Justice filed indictments against Holmes and Balwani.
Holmes’ trial was delayed multiple times due to the COVID-19 pandemic and her pregnancy. On January 3, 2022, Holmes was found guilty on three counts of defrauding investors and one count of wire fraud. She is scheduled to be sentenced in September 2022.
Balwani’s trial concluded on July 7, 2022, with him being found guilty on two counts of conspiracy and ten counts of wire fraud. Balwani is scheduled to be sentenced in November 2022.
Value-based reimbursement is the payment model for medical services that is gradually replacing the traditional fee-for-service model for payers and healthcare organizations. The goal is to cut rising healthcare costs by switching from a model based on quantity to value-based reimbursement, which is based on quality.
Value-based reimbursement is considered a way to cap costs and spread financial risk among providers, while encouraging coordination of care, disease prevention and better management of chronic conditions. This is seen as a threat to the survival of clinical labs, which expect to see far fewer tests ordered by healthcare providers.
In partnership with THE DARK REPORT, the Clinical Laboratory Management Association is working to help labs navigate these revenue-threatening changes. “As fee-for-service reimbursement gives way to bundled reimbursement and per-member-per-month payment, labs will only be successful if they add value to physicians by helping them diagnose disease earlier and more accurately,” says CLMA President Paul Epner.
Medicare, the largest payer in the U.S., has recently been ordered by the Department of Health and Human Services to link 30 percent of fee-for-service payments to quality or value through alternative payment models, such as accountable care organizations (ACOs) or bundled payment arrangements by the end of 2016, and tying 50 percent of payments to these models by the end of 2018.
An ACO, for example is a group of doctors, hospitals and health care providers who work together to provide higher-quality coordinated care to their patients, while helping to slow health care cost growth. In addition to this, through the widespread use of health information technology, the health care data needed to track these efforts is now available.
HHS also set a goal of tying 85 percent of all traditional Medicare payments to quality or value by 2016 and 90 percent by 2018 through programs such as the Hospital Value Based Purchasing and the Hospital Readmissions Reduction Programs. This is the first time in the history of the Medicare program that HHS has set explicit goals for alternative payment models and value-based payments.
Don’t Be at the Mercy of the Tumultuous Healthcare Revolution
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