Lesson 1-1

How does the HIPAA affect workers in the laboratory?

1. Patient information stored in computers must be password protected. 2. Computer monitors must be positioned so non-authorized personnel cannot view the screen. 3. All patient information must remain private and confidential and must be shared only with authorized persons to facilitate and improve patient care.

Define waived test

A category of test defined under CLIA '88 as being simple to perform and having an insignificant risk for error.

Define anticoagulant

A chemical or substance that prevents blood coagulation.

How do laboratories become accredited?

A facility desiring accreditation invites the accrediting agency to inspect its facility and evaluate its performance to determine if established standards are being met.

Define phlebotomist

A healthcare worker trained in blood collection.

Define pathologist

A physician specially trained in the nature and cause of disease.

Define accreditation

A voluntary process in which an independent agency grants recognition to institutions or programs that meet or exceed established standards of quality.

Define AABB

American Association of Blood Banks. The international association that sets blood bank standards, accredits blood banks, and promotes high standards of performance in the practice of transfusion medicine.

Define reference laboratory

An independent regional laboratory that offers routine and specialized testing services to hospitals and physicians.

Name five benefits of electronic health records

Better coordination of patient care, Improved follow-up after hospitalization, Maintain comprehensive information about patient's health in one file, Provide a secure way to share patient information, and Motivate patient to comply with recommendations.

Name five procedures performed in the hematology department.

Blood cell counts, hemoglobin counts, hematocrit, examinations of blood smears, and coagulation tests.

What is the purpose of CLIA '88?

CLIA '88 specifies minimum standards for all clinical laboratories. The objective of CLIA '88 is to ensure quality laboratory testing.

What federal agency is responsible for implementing CLIA '88?

CMS (formerly known as HCFA) is responsible for implementing CLIA '88.

Define CDC

Center for Disease Control. Central laboratory for the national public health system.

Define CMS

Centers for Medicare and Medicaid Services. The agency within DHHS responsible for implementing CLIA '88.

What are the five certificates issued under CLIA '88?

Certificate of Waiver, Registration Certificate, Certificate of Compliance, Certificate of Accreditation, and Certificate for PPMP.

Define CLIA '88

Clinical Laboratory Improvement Amendments of 1988. A federal act that specifies minimum performance standards for clinical laboratories.

Define CLSI

Clinical and Laboratory Standards Institute. An international, non-profit organization that establishes guidelines and standards of best current practice for clinical laboratories; formerly National Committee of Clinical Laboratory Standards (NCCLS)

What is the function of a clinical laboratory?

Clinical laboratories perform chemical and microscopic tests on body fluids and tissues to aid in diagnosis of diseases

Define Blood Bank

Clinical laboratory department where blood components are tested and stored until needed for transfusion; immunohematology department; transfusion services; also the refrigerated unit used for storing blood components.

Define CAP

College of American Pathologists. The organization that offers accreditation to clinical laboratories.

Explain the job functions of the technical supervisor/laboratory manager.

Handles the day-to-day operation of the laboratory, sets personnel standards, and supervises employee performance. Is normally a medical laboratory scientist (MLS) with a B.S. or M.S. and years of laboratory experience.

Define HCFA

Health Care Financing Administration; former name of Centers for Medicare and Medicaid Administration (CMS).

Define HIPPA

Health Insurance Portability and Accountability Act. A 1996 act of Congress, a part of which guarantees protection of privacy of an individual's health information.

Define quality assessment

In the lab, a program that monitors the total testing process with the aim of providing the highest quality patient care.

What is contained in the SOP manual?

It contains the up-to-date instructions for all procedures performed in the laboratory.

Define JC

Joint Commission. An independent agency that accredits hospitals and large healthcare facilities; formerly known as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO).

Define LRN

Laboratory Response Network. A national network of public and private laboratories coordinated by the CDC with the ability for rapid response to threat to public health.

Name seven major departments found in a hospital laboratory

Microbiology, Chemistry, Blood Bank, Immunology, Hematology, Lab support services (specimen collection and processing), and Laboratory Information Systems

Define NCCLS

National Committee for Clinical Laboratory Standards; former name of Clinical and Laboratory Standards Institute.

List five locations of clinical laboratory facilities other than in hospitals.

Physician offices, State and federal government facilities (public health), Universities, Research institutions or facilities, and Reference laboratories

Define POL

Physician-Office Laboratory. A small medical laboratory located within a physician office, group practice, or clinic.

Define POCT

Point-of-Care-Testing. Testing outside of the traditional laboratory setting; aka bedside testing, off-site testing, near-patient testing, or alternative-site testing.

Define SOP

Standard Operating Procedure. An established procedure to be followed for a given operation in a given situation with the purpose of ensuring said procedure is always carried out correctly and in the same manner.

Define COLA

The agency that offers accreditation to physicians office laboratories, hospitals, clinics, and other healthcare facilities; formerly known as the Commission on Office Laboratory Accreditation.

Define microbiology

The branch of biology dealing with microbes.

Define immunology

The branch of medicine encompassing the study of immune processes and immunity.

Define clinical chemistry

The laboratory section that uses chemical principles to analyze blood and other body fluids.

Define serum

The liquid obtained from blood that has been allowed to clot.

Define plasma

The liquid portion of blood in which the white blood cells are suspended; the straw-colored liquid remaining after blood cells are removed from anti-coagulated blood.

Define accessioning

The process by which specimens are logged in, labeled, and assigned a specific identification code.

Define coagulation

The process of forming a fibrin clot.

Define serology

The study of antigens and antibodies in serum using immunological methods; laboratory testing based on the immunological properties of serum.

Define bacteriology

The study of bacteria.

Define hematology

The study of blood and the blood-forming tissues.

Define mycology

The study of fungi.

Define parasitology

The study of parasites.

Define pathology

The study of the causes and effects of diseases.

Define epidemiology

The study of the factors that cause disease and determine disease frequency and distribution.

Define Immunohematology

The study of the human blood groups; in the clinical laboratory, often called blood banking or transfusion services.

Define virology

The study of viruses.

Who is responsible for creating the laboratory's SOP manual?

The technical supervisor/laboratory manager is responsible for the information and keeping the manual up-to-date.

Explain the job functions of the laboratory director

Ultimate responsibility for all laboratory operations; may be a pathologist, a qualified M.D., or a doctoral scientist.

What are waived tests?

Waived tests are those that are determined by CDC or FDA to be so simple that there is insignificant risk for error.

What are the activities permitted by a CLIA '88 Registration Certificate?

permits the laboratory to (temporarily) conduct moderate- or high-complexity laboratory testing (or both) until the laboratory is determined by survey to be in compliance with CLIA regulations.

What are the activities permitted by a CLIA '88 Certificate for PPMP?

permits the laboratory to perform waived tests and allows a physician, midlevel practitioner, or dentist to perform microscopy procedures but no other tests of complexity.

Define FDA

Food and Drug Administration. The division of the DHHS responsible for protecting the public health by ensuring the safety and efficacy of foods, drugs, biological products, medical devices, and cosmetics.

Name six tests performed in the chemistry department.

Glucose, Electrolytes, Cholesterol, Enzymes, Drug levels, and Hormone levels.

Define DHHS

Department of Health and Human Services. The governmental agency that oversees public healthcare matters; also called HHS.

Define EHR

Electronic Health Records. A comprehensive, portable, electronic, patient health record.

Define EMR

Electronic Medical Record. A digital form of a patient chart created in a physician's office or a hospital where a patient is receiving treatment.

Define PT

Proficiency Testing. A program in which a laboratory's accuracy in performing analyses is evaluated at regular intervals and compared to the performance of similar laboratories.

What is the advantage of proficiency testing?

Proficiency testing programs evaluate a laboratory's performance for accuracy and compare it to that of other laboratories. This allows the laboratory to have confidence in testing methods and to identify deficient areas.

Define PPMP

Provider-Performed Microscopy Procedure. A certificate category under CLIA '88 that permits a laboratory to perform waived test and also permits specified practitioners to perform on-site microscopy procedures.

Explain the job functions of the department head/general supervisor.

Responsible for work within a specific department and for training and evaluating employee performance. Is normally a medical laboratory scientist (MLS) with a B.S. and experience/expertise related to the particular laboratory section. May have an additional specialty certification in that area.

What are the activities permitted by a CLIA '88 Certificate of Compliance?

issued to a laboratory holding a Certificate of Registration after an inspection finds the laboratory to be in compliance with all applicable CLIA regulations.

What are the activities permitted by a CLIA '88 Certificate of Accreditation?

issued to a laboratory that has been accredited by a CMS-approved accrediting organization.

What are the activities permitted by a CLIA '88 Certificate of Waiver?

permits a laboratory to perform CLIA-waived tests only.