Chapter 1 Flashcards
Clinical laboratory testing plays a crucial role in
the detection, diagnosis, and treatment of disease.
➢After collecting and examining a specimen,
laboratory professionals analyze and communicate results to physicians or other primary care providers.
Employment in the profession is
expected to grow faster than average.
The American Society for Clinical Pathology
ASCP
ASCP
The American Society for Clinical Pathology
ASCP
The American Society for Clinical Pathology (ASCP) created the Board of Registry (BOR) in 1928 to certify laboratory professionals. Individuals who passed the BOR’s registry exam were referred to as “medical technologists,” identified by the acronym “MT (ASCP).” https://www.ascp.org/content
ASCLT
n 1933, the American Society of Clinical Laboratory Technicians (ASCLT) was formed. Today, this organization is known as the American Society for Clinical Laboratory Science (ASCLS). Established to give greater autonomy and control over direction of profession. https://www.ascls.org/
ASCLT
American Society of Clinical Laboratory Technicians
American Society of Clinical Laboratory Technicians
ASCLT
NAACLS
In 1973 the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS) was formed. https://www.naacls.org/about.aspx
NAACLS
National Accrediting Agency for Clinical Laboratory Sciences
National Accrediting Agency for Clinical Laboratory Sciences
NAACLS
During the 1960s, new categories of laboratory professionals joined generalist medical technologists in performing the daily work of the clinical laboratory
. The category of medical laboratory technician (MLT) was developed as a 2-year associate’s degree program.
Specialist categories in chemistry, microbiology, hematology, and blood banking were created
Specialists certified in cytotechnology, histotechnology, laboratory safety, and molecular pathology/molecular biology have evolved as well.
Technicians certified as donor phlebotomists or phlebotomy.
technicians are part of the laboratory team.
Pathologists’ assistants are another category of specialty certification.
Certification as a Diplomat in Laboratory Management is available.
Additional individual professional certification and licensure
Numerous states and US territories currently require licensu
New York Hawaii California ◦ Florida ◦ Georgia. ◦ Louisiana ◦
Montana Nevada North Dakota Tennessee. West Virginia
Professional recognition in 2009
◦ Generalists became referred to as medical laboratory scientists (MLSs).
◦ The similar technician-level designation continued to be designated as medical laboratory technicians (MLTs).
◦ The appropriate professional credentialing is MLS(ASCP) and MLT(ASCP). ◦ Continuing education is a requirement for certified professionals to maintain
certification.
In 2012 a post-baccalaureate degree, the doctorate in clinical laboratory science (DCLS), was approved in the United States
o This credential is beyond that of the entry-level generalist and represents the terminal advanced-practice degree in the profession.
o NAACLS categorizes the responsibilities of the DCLS into five areas: – **patient care management
**education **research applications **health care policy development **health care
services delivery and access
o https://shp.rutgers.edu/clinical-lab-and-imaging-sciences/doctorate- of-clinical-lab-science/
oThe laboratory serves to educate
the physician and other health care providers so that the information available through the reported test results can be used appropriately.
oWhen tests are ordered, the clinical laboratory should assume a
oWhen tests are ordered, the clinical laboratory should assume a role of leadership and education in assisting the physician to serve the best interest of the patient, improve the clinical decision-making process for the physician, and consider the costs involved. oTypically only a small percentage of available tests are routinely ordered. oTests improve clinical decision-making.
Pathologist or PhD as director
Clinical laboratory personnel
◦ Laboratory supervisor or manager
◦ Responsible for the technical aspects of managing the laboratory
◦ Additionally, a business manager may handle administrative details.
◦ Ensures all federal, state, and local regulatory mandates are followed by the laboratory
◦ Technologists, technicians, and specialists
Duties of technologists, technicians, and specialists
Duties of technologists, technicians, and specialists
◦ The responsibilities of MLS and MLT laboratorians vary but may include performing some of the same laboratory assays, supervising other staff, teaching, or research.
◦ Because of in-depth knowledge of technical aspects, principles of methodology, and instrumentation used for the various laboratory assays, the laboratory professional is able to correlate and interpret the data.
◦ Although MLS and MLT may collect blood specimens or process them, phlebotomists collect blood specimens in larger hospitals.
Goals were to ensure high quality of lab results.
CLIA requirements for personnel
◦ Define the responsibilities, educational requirements, training, and experience of employees performing tests of moderate or high complexity.
◦ There are no CLIA regulations for testing personnel who work at sites performing only waived tests or provider-performed microscopy testing.
◦ Requirements are more stringent for those performing tests of the highly complex category.
Clinical Laboratory Improvement Amendments (CLIA) of 1988
Levels of general laboratory testing include waived tests, moderately complex tests, and highly complex tests.
The criteria for classification include:
◦ Risk of harm to the patient
◦ Risk of an erroneous result
◦ Type of testing method used
◦ Degree of independent judgment and interpretation needed ◦ Availability of the test in question for home use
Waived tests
Cleared by the US Food and Drug Administration for home use
◦ Use simple methodologies unlikely to cause erroneous results and pose no reasonable risk of harm to the patient if performed incorrectly
◦ Examples: dipstick urinalysis and blood glucose
Provider-performed microscopy (PPM)
◦ Must be personally performed by the practitioner (defined as a physician, a midlevel practitioner under the supervision of a physician, or a dentist)
◦ Must be categorized as moderately complex
◦ The primary instrument for performing the test is the microscope (limited to
brightfield or phase-contrast microscopy). ◦ The specimen is labile.
◦ Control materials are not available.
◦ Specimen handling is limited.
oThe organization of a particular clinical laboratory depends on its size, the number of tests done, and the facilities available.
◦ Larger laboratories tend to be departmentalized; a separate area is designated for each of the various divisions. Cytogenetics, toxicology, flow cytometry, and other specialized divisions (such as molecular diagnostics) are present in larger laboratories.
oThe trend is to have a more “open” design or a core laboratory where hematology, urinalysis, hemostasis/coagulation, and clinical chemistry share work space.
oCross-training is important in a core laboratory model.
oA working clinical laboratory is traditionally organized into several major scientific disciplines:
:blood banking/transfusion medicine, clinical chemistry (may include toxicology), flow cytometry, hematology and hemostasis, immunology and serology, microbiology, and urinalysis.
oThe core laboratory configuration combines routine
hematology, hemostasis and blood coagulation, and clinical chemistry.
oEach specialty department focuses on a different area of
laboratory medicine.
oMany medium to large size laboratories have developed a central testing area with a cluster of instruments devoted to high volumes of test samples.
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oExpanded directions of laboratory testing include molecular diagnostics, an application of biotechnology.
◦ Applies the principles of basic molecular biology to the study of human diseases
◦ Provides information related to molecular genetics research as real-time information for applications such as gene therapy, genetic screening, stem cell research, cloning, and cell culture
Modern health care organizations have many different configurations, depending on the geographic region and market, mix of patients, overall size, and affiliations.
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◦ The size of health care organizations ranges from the very large tertiary care–level teaching hospitals, to community hospitals, to freestanding specialty clinics or phlebotomy drawing stations.
◦ A common organizational structure for a hospital includes the chief executive officer and the board of trustees, who set policy and guide the organization.
◦ The chief operating officer is responsible for implementing policies and daily activities.
oOther high-level positions can include the chief financial officer, chief information officer, and chief technology officer, depending on the size of a health care organization.
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oA variable number of vice presidents (VPs) have several departments reporting to them.
oOrganizations usually have VPs of nursing, clinical services, general services, and human resources.
oThe VP of clinical services oversees the managers of the clinical laboratory as well as radiology and pharmacy.
There are three primary laboratory accrediting organizations:
Commission on Office Laboratory Accreditation (COLA)
College of American Pathologists (CAP): an internationally recognized program that utilizes teams of practicing laboratory professionals as inspectors
The Joint Commission (TJC) has been evaluating and accrediting hospital laboratory services since 1979 and freestanding laboratories since 1995.
Other specialty organizations, including the American Association of Blood Banks, American Society of Histocompatibility and Immunogenetics, and American Osteopathic Association, accredit additional facilities.
Commission on Office Laboratory Accreditation
COLA
COLA
Commission on Office Laboratory Accreditation
College of American Pathologists
College of American Pathologists (CAP): an internationally recognized program that utilizes teams of practicing laboratory professionals as inspectors
College of American Pathologists
CAP
CAP
College of American Pathologists
College of American Pathologists (CAP) is
an internationally recognized program that utilizes teams of practicing laboratory professionals as inspectors
The Joint Commission (TJC) is
has been evaluating and accrediting hospital laboratory services since 1979 and freestanding laboratories since 1995.
The Joint Commission
TJC
TJC
The Joint Commission
Other specialty organizations, including the American Association of Blood Banks, American Society of Histocompatibility and Immunogenetics, and American Osteopathic Association, accredit additional facilities.
American Association of Blood Banks,
American Society of Histocompatibility and
Immunogenetics, and
American Osteopathic Association,
accredit additional facilities.
In addition to CLIA’88, other state and federal regulations regulate chemical waste disposal, use of hazardous chemicals, and issues of laboratory safety, including handling of biohazardous materials and application of Standard Precautions.
◦ External controls include standards mandated by public health laws and reporting requirements through the Centers for Disease @Control and Prevention (CDC) and through certification @and @licensure requirements issued by the US Food and Drug (FDA).@
◦ State regulations are imposed by Medicaid agencies, state environmental laws, and state public health laws and licensure laws.
◦ Local regulations include those determined by building codes and fire prevention codes.
Alternate Sites of Testing
Point-of-Care Testing
Reference Laboratories
Physician Office Laboratories
Informed consent
◦ Informed consent means
that the patient is aware of, understands, and agrees to the nature of the testing to be done and what will be done with the results reported.
Confidentiality
◦ 1996: Health Insurance Portability and Accountability Act (HIPAA)
◦ Any results obtained for specimens from patients and any information about the patient must be kept strictly confidential.
New patient access regulations
◦ A new final rule by the Centers for Medicare and Medicaid Services (CMS) grants patients direct access to their laboratory results.
◦ The new final rule does not require that laboratories interpret test results for patients.
◦ Laboratories may continue to refer patients with questions about test results back to their ordering or treating health care providers.
A new final rule by the Centers for Medicare and Medicaid Services (CMS) grants patients direct access to their laboratory results.
◦ The new final rule does not require that laboratories interpret test results for patients.
◦ Laboratories may continue to refer patients with questions about test results back to their ordering or treating health car
Centers for Medicare and Medicaid Services (CMS)
CMS)
Centers for Medicare and Medicaid Services
CMS
Chain of custody
◦ When specimens are involved in possible medicolegal situations, certain specimen-handling policies are required.
◦ For evidence to be admissible, each step of the analysis, beginning with the moment the specimen is collected and transported to the laboratory, to the analysis itself and the reporting of the results, must be documented; this process is known as “maintaining the chain of custody.”
Other legal considerations
◦ Health care organizations and their employees are obliged to provide an acceptable standard of care, defined as the degree of care a reasonable person would take to prevent an injury to another.
Medical Ethics
o Personal ethics are based
o Personal ethics are based on values or ideals and customs that are held in high regard by an individual or group of people.
o Ethics also encompasses the principles of conduct of a group or individual, such as professional ethics.
o ASCLS endorses a professional Code of Ethics, which states that all laboratory professionals have a responsibility for proper conduct toward the patient, colleagues and the profession, and society.
o In addition, ASCLS has a Pledge to the Profession. https://www.ascls.org/about-us/code-of-ethics
Patient Safety
oA study of laboratory errors showed that 98% of the errors in the diagnostic process occur in the preanalytic phase.
oHaving recognized the role of preanalytical errors, the Joint Commission National Patient Safety Goals has several goal areas that have specific applications for clinical laboratories.
oCommunications and mitigating patient risk are two main areas of patient safety.
