Chapter 1 Flashcards
Clinical laboratory testing plays a crucial role in-
Detection, diagnosis, & treatment of disease
After collecting & examining a specimen, lab professionals-
Analyze & communicate results to physicians or other primary care providers
ASCP stands for-
American Society for Clinical Pathology
ASCP created-
Board of Registry (BOR)
The Board Of Registry (BOR) is now known as-
Board Of Certification (BOC)
When did BOR become BOC?
1928
What does BOC do?
Certify lab professionals
An individual who passed the BOR’s registry exam was referred to as-
A medical technologist
What is the acronym for a medical technologist?
MT (ASCP)
When was the American Society of Clinical Laboratory Technicians formed?
1933
What is the American Society of Clinical Lab Technicians now known as?
American Society for Clinical Lab Science (ASCLS)
When did new categories of lab professionals join generalist medical technologists in performing daily work of the clinical laboratory?
During the 1960s
The category of MLT was developed as-
A 2-year associates degree program
What specialty categories were created? (5)
-chemistry
-microbiology
-hematology
-immunology
-blood banking
Additional certifications available- (5)
-phlebotomy
-cytotechnology
-histotechnology
-lab safety
-molecular pathology/biology
When did lab professionals gain professional recognition?
September 2009
Generalists are now referred to as-
Medical Lab Scientists (MLS)
Similar technician-level designation continued to be designated as-
Medical Lab Technicians (MLTs)
Appropriate professional credentialing-
MLS (ASCP) & MLT (ASCP)
Continuing education is now a requirement for-
Certified professionals to maintain certification
Another category of specialty certification-
Pathologists’ Assistant
MLAs are critically important to-
Medical field & lab science
MLAs play an important role in-
Helping lab tests get processed
It is important that the lab serves to educate-
The physician & other healthcare providers
Why is it important that the lab serves to educate the physician & other healthcare providers?
So info available through the reported test results can be used appropriately
When tests are being ordered, the clinical lab should- (4)
-Assume a role of leadership & education in assisting the phlebotomist to understand
-serve the best interest of the patient
-improve the clinical decision-making for physicians
-consider the costs involved
When the results of these tests are used appropriately, clinical decision making will be improved in the context of-
-patient’s clinical case
-physical examination findings
-medical history
Most clinical labs are operated under-
The direction of a pathologist or PhD
A lab has a supervisor/manager who is responsible for-
The technical aspects of managing the lab
A business manager may be hired to-
Handle administrative details
Administrative techs, regardless of the job title, is ensuring-
That all federal, state, & local regulatory mandates are being followed by the lab
The responsibilities of MLSs & MLTs vary, but may include- (3)
-performing some of the same lab assays
-supervising other staff
-teaching
Because of in-depth knowledge of technical aspects, principles of methodology & instrumentation used for various lab assays, lab professionals are-
Able to interpret & correlate data
MLSs & MLTs collect blood in-
Smaller facilities
Phlebotomists collect blood specimens in-
Large hospitals
CLIA stands for-
Clinical Lab Improvement Amendments
The goal of CLIA-
To ensure that lab results reported are high quality regardless of where testing is done (small labs, physician’s office, large reference lab, or patient’s home)
CLIA defines responsibilities of-
Persons working in each testing site where tests of moderate/high complexity are done
There are no CLIA regulations for-
Testing personnel who work at sites performing only waived tests
For tests of high complex category, personnel requirements are-
More stringent
Tests performed by the lab- (4)
-waived tests
-moderately complex tests
-highly complex tests
-provider-performed microscopy (PPM)
Criteria for classification include- (5)
-risk of harm to patient
-risk of erroneous result
-type of testing method used
-degree of independent judgement & interpretation needed
-availability of particular test in question for home use
Waived test is defined as-
Those cleared by the US FDA for home use
Tests cleared by the US FDA for home use employ-
Methodologies unlikely to cause erroneous results & pose no reasonable risk of harm to the patient if the test is performed incorrectly
Waive tests include- (2)
-Dipstick urinalysis
-blood glucose
The organization of a particular clinic lab depends on- (3)
-its size
-number of tests done
-facilities available
Larger labs tend to be-
Decompartmentalized; a separate area is designated for each of the various divisions
The current trend is to have more “open” design or a core lab where-
Hematology, urinalysis, hemostasis/coagulation, & clinical chemistry share workspace
Cross training is important in-
A core lab model
Other specialized divisions present in large labs- (3)
-cytogenetic
-toxicology
-flow cytometry
A working clinical lab is traditionally organized into several major scientific disciplines-
-Blood banking/transfusion medicine
-clinical chemistry
-hematology & hemostasis
-immunology & serology
-microbiology
-urinalysis
Core lab configuration combines- (3)
-hematology
-hemostais & blood coagulation
-clinical chemistry
Each specialty department focuses on-
A different area of lab medicine
3 primary accrediting organizations-
-Commission on Office Lab Accreditation (COLA)
-College of American Pathologists (CAP)
-The Joint Commission (TJC)
COLA helps labs-
Stay in compliance with the new CLIA regulations
Cap is an internationally recognized program & the only one of its kind that-
Uses teams of practicing lab professionals as inspectors
TJC has been evaluating & accrediting hospital lab services since-
1979
TJC has been evaluating & accrediting free-standing labs since-
1995
POCT is the decentralization of testing away from the traditional lab setting can greatly increase-
The interaction of lab personnel with patients & members of the healthcare team
Informed consent-
The patient is aware of, understands, & agrees to the nature of testing to be done & what will be done with the results reported
Implied consent-
When a patient enters the hospital to the many routine procedures that will be performed while the patient is there
Ex. of a test that carries implied consent
Venipuncture
Patients must sign specific consent for more complex procedures, such as- (4)
-bone marrow aspiration
-lumbar puncture for collection of cerebrospinal fluid
-fine-needle biopsy
-non urgent transfusion of blood or its components
Patients should be given sufficient info about-
The reasons why the informed consent is needed & must be given the opportunity to ask questions
When should a guardian’s consent be obtained? (5)
-when the patient is a minor
-legally not competent
-physically unable to write
-hearing impaired
-doesn’t speak English as the first language
Any results obtained for specimens from patients must be kept-
Strictly confidential
HIPAA-
Health Insurance Portability & Accountability Act
HIPAA requires-
Any info about the patient including the measurements being done, must also be kept in confidence
The only person who should have access to info about a patient-
Authorized personnel
Any release of patients info to non-health care persons can be done only when-
Authorized by the patient
Communications from LIS should meet-
HIPAA compliances for encryption & methodology
HIPAA rules apply to any health info that can be linked to the patient by- (4)
-name
-social security number
-employee number
-hospital ID number
A new final rule by CMS grants patients direct access to-
Their lab results
The new final rule doesn’t require-
That labs interpret test results for patients
Labs may continue to refer patients with questions about tests results to-
Their ordering or treating health care provider
Required when specimens are involved in possible medicolegal situations-
Certain specimen-handling policies
Maintaining the chain of custody-
For evidence to be admissible, the moment the specimen is collected & transported to the lab, to the analysis itself, & the reporting of the results must be documented
Personal ethics are based on-
Values or ideas & customs that are held in high regard by an individual or group of people
Ethics also encompasses the principles of conduct of-
A group or individuals, such as professional ethics
ASCLS endorses a professional code of ethics which states-
All lab professionals have a responsibility for proper conduct toward the patient, their colleagues, * the profession & the society
