QUALITY CONTROL AND QUALITY ASSURANCE phases important for viva or interview

QUALITY CONTROL :- These are three types

1) Preanalytical Phase :-

• Requisition appropriately filled out

• Patient preparation

• Patient identification

• Sample identification; three identifiers must be used

• Correct sample collection techniques; venipuncture performed correctly, etc.

• Correct storage and transportation of sample

• Correct storage of testing kits and quality control materials

• Appropriate training of personnel

• Preparation of standard operating procedures and policy

• manuals for reference

Retention of current package inserts for correct instructions.

2) Analytical Phase:-

• Valid test kit; not expired and stored correctly

• Instrument properly maintained and calibrated

• Proper mixing/preparation of quality control samples

• Proper mixing/preparation of patient samples Following manufacturer instructions exactly as written for CLIA-waived tests

• Proper documentation of quality control results; verification of acceptable QC values before patient sample is analyzed

• Order/perform confirmatory tests as recommended by manufacturer

3) Postanalytical Phase:-

• Appropriate documentation of patient results

• Appropriate units reported with test results

Results transmitted to health-care provider in timely manner

• All critical results called immediately

Include correct reference ranges with laboratory results

• Report all test results to authorities as required by law

•Properly dispose of used testing materials

Sterilization used in Microbiology Are?

However, it is impossible and impractical to sterilize our environment in the laboratory, which would involve the elimination of all

microorganisms. 

1) Sanitization:  reduces the number of

microorganisms on a surface with cleaning. Heat or chemicals are often used for sanitization in the health care environment .

2) Disinfection:  is the process by which

a medical assistant applies a chemical to a surface to kill the pathogenic microorganisms that may be present.Sanitization is often performed before an item is disinfected.

Eg: (equipment are disinfected on a regular basis. Skin may also be disinfected, as it is impossible to sterilize the skin by eliminating all the microorganisms. Seventy percent

isopropyl alcohol or povidone-iodine solutions are used for skin disinfection. Work surfaces and equipment are often disinfected in the laboratory with a freshly  prepared 10% bleach solution.

)

☆ Asepsis means that a surface is without infection. In the medical environment, there are two types of asepsis.

3) A) Surgical asepsis .

 

    B) Medical asepsis  .

i) • Temperature: The optimum temperature for each  microorganism will vary. Human pathogens tend to prefer our body temperature, so they grow best at approximately 98.6°F.

ii) • pH: A neutral pH is best suited for most microorganisms. This is why many disinfectants and cleaning agents are basic or acidic, as they will kill the microorganisms by making their environment inhospitable.

iii) • Darkness: and moisture: Most microorganisms like darkness or dim light, and they all need moisture to survive.

iv) • Nutrition: The type of nutrition varies depending on the type of microorganism, but they all need something in their environment to use as a food source.

V) Oxygen: Aerobic microorganisms need oxygen present for survival. Anaerobic microorganisms are best suited for environments that have an absence or low

levels of oxygen.

Types of Microorganisms

Types of Microorganisms:

☆ bacteria, viruses, fungi, protozoa, and parasites are capable of causing disease in the human body. These disease-causing organisms are known as pathogens. An

infection is the invasion of the body by pathogens that then cause disease symptoms .

1) Bacteria:  Bacteria are single-celled organisms that have a cell wall in addition to the cell membrane that our human cells possess. (This is an important property

when identifying different types of bacteria with special stains ). Of all the bacteria

known to exist, approximately 4% are known to cause disease in humans.

• An initial step of the identification process is to examine a sample under the microscope so that the bacteria can be classified according to one of three basic shapes,

i) Cocci are three type---> a) staphylococci b) Streptococci c) Diplococci .

Eg: Diseases caused by cocci include streptococcal sore throat, pneumonia, abscesses, food poisoning, gon-

orrhea, and meningitis.

ii) bacilli : Bacilli cause diseases such as botulism, tetanus, diphtheria,  tuberculosis, and salmonella food poisoning. E. coli is a

normal bacilli that is present on our skin and in our intestines, but if we come in contact with a specific strain, E. coli O157:H7, it may lead to serious food poisoning, and may even be fatal.

iii) Spirilla:  but the infections may be quite serious when they occur. Treponema pallidum is a spirillum that causes syphilis, and cholera is caused by another type of spirillum. 

2) Viruses: Viruses are another common type of patho-genic microorganism. They are the smallest infectious agent, and are not really cells. Viruses are either made  up of RNA or DNA surrounded by a protein capsule,

and require a host cell to survive and replicate. Viruses cannot be observed using a simple microscope such as is found in most laboratories; they require use of an

electron microscope for visualization. They invade the cells of our body, and use our own structures to make more virus particles. Viruses cause many of the diseases

for which we are vaccinated, including measles, mumps, and chickenpox. 

Antiviral medications are available for some viral infections, but because of the way virus particles use human cells, the treatment may

be quite damaging to the host as well as to the virus.  Antibiotics are not effective against viruses.

3) Fungi: Fungi are plant-like organisms that flourish in an environment that is dark and damp. Yeast is a type of fungus, and fungal infections on the body are called  mycotic infections. Athlete’s foot and ringworm are 

examples of fungal infections.

 

4) Parasites:  Parasites are similar to viruses because they require a living host to survive. A genus of bacteria known as Rickettsia is parasitic. Parasites take their nourishment

from the host and require their host cells to reproduce, but they do not utilize the human cell in the same way that a virus does. Malaria is an example of a parasitic disease; the

malaria parasite actually works into the red blood cells of the host and causes the patient to become ill. The word parasite may also be used to refer to larger, multicellular organisms such as tapeworms, which live inside the 

human host and use the body to survive.

5) Protozoa: Protozoa are complex single-cell microorganisms, most of which are nonpathogenic. However, there are a few species that can cause very serious infec-

tions in humans. Protozoa live in the soil and water.

THREE PHASES OF LABORATORY TESTING

THREE PHASES OF LABORATORY TESTING;-

1) Preanalytical :- 

All procedures/processes that occur before the specimen is actually tested. Includes patient preparation,accurate paperwork and data entry, appropriate specimen collection, processing, storage and transportation.

2) Analytical :- 

All procedures/processes involved in the testing of the specimen. This includes the way the testing instrument was prepared and maintained, how the testing supplies were stored, appropriate training of the personnel performing the test, and quality control to ensure that the testing methods are working properly.

 

3) Postanalytical :- 

All procedures/processes that affect how the test results are handled when the analysis has been completed. These may include review and analysis of the results by the person performing the test, appropriate follow-through on extremely high or low results, how the results are recorded (in a computer or on paper, etc.) phone calls, report printing, report sorting, appropriate fax procedures, charting procedures within an

office, physician review procedures, contact with patient if necessary for follow-up.

● quality control (QC):-  

measures, which are in place to validate the test reagents/kits, the testing process, and

training of the laboratory personnel performing the test.

• Postanalytical Phase: 

The postanalytical phase of laboratory testing includes the processes associated with the recording and reporting of laboratory results,

storage and/or disposal of specimens after testing, and provider and patient notification of test results. Even if the other two phases of testing occur without any exceptions, if this phase isn’t handled appropriately, then the overall experience will not be a positive one,

and may negatively affect patient treatment.

LABORATORY DEPARTMENTS

Summary of Laboratory Departments, Common Tests Performed, and Specimen Types: 

Types of Laboratory Department: with definition 

Approx 9 type are present

1) Specimen Processing:   

● Incoming specimens sorted

● Specimens accessioned into computer system

● Specimens labeled and prepared for testing in separate department .

Specimen Types:- All.

2) Hematology : 

● Complete blood count

● Hemoglobin and hematocrit measurements

● Coagulation studies

● Erythrocyte sedimentation rate

● Differential white blood cell count

● Platelet counts

☆Specimen Types:- Whole blood .

3) Clinical Chemistry :  

● Electrolytes

● Glucose

● Blood urea nitrogen

● Creatinine

● Thyroid testing

● Cardiac enzyme testing

● Comprehensive metabolic panel

● Cholesterol/lipid testing

● Many automated chemistry tests and panels

☆ Specimen Types;- Serum, plasma,

urine, cerebrospinal fluid, amniotic fluid.

4) Serology and Immunohematology :   

¤ Various tests looking for antigens and/or antibodies such as:

● RPR

● Mononucleosis testing

● HIV tests

● Chlamydia testing

● Antistreptolysin O test

● Pregnancy testing

● C-reactive protein

● ABO/Rh blood typing

● Antibody screens and crossmatches for transfusions

● Newborn testing

● Prenatal testing

☆ Specimen Types :- Serum, plasma,

whole blood .

5) Urinalysis : 

● Physical appearance of urine

● Urine chemical analysis

● Microscopic urine analysis

☆Specimen Types :- urine.

6) Microbiology/Parasitology :

● Identification of pathogenic microorganisms

● Streptococcal screens

● Antibiotic sensitivity testing

☆ Specimen Types :- Blood, urine, wound

specimens, tissue,stool, cerebrospinal

fluid, sputum, urethral and vaginal

discharge, nails,skin scrapings.

7) Cytology : 

● Examination of various specimens for abnormal cells Chromosomal studies

Pap smears .

☆ Specimen Types :-  Urine, skin, tissue

specimens, sputum .

8) Coagulation : 

● Testing for presence or absence of adequate clotting factors

☆ Specimen Types:- Whole blood.

9) Histology/Pathology : 

● Examination for abnormal form and structure in tissues

☆ Specimen Types:Tissue/organs,

biopsy specimens from various parts

of the body, preserved and fresh

specimens examined .

1) • Specimen Processing: The area of the laboratory where all incoming specimens are sorted, accessioned into the computer system of the laboratory, and appropriately labeled for transport to their respective

departments for testing. The specimen processing department may also prepare specimens for transport to reference laboratories.

2) • Hematology: Whole blood testing, which focuses on the formed elements (the blood cells) in the blood.Coagulation testing is also performed in this department.

3) • Clinical Chemistry: Testing performed on plasma or serum (the liquid portion of the blood) and includes analysis of the substances dissolved in the bloodstream. Most testing is automated, and many of the tests are performed as panels or groups of tests.

4) • Serology/Immunohematology: Testing that focuses primarily on the presence of antigens or antibodies  on cells or in the liquid portion of the blood. Blood typing and antibody screens and crossmatches for transfusions may also be performed in this department.

5) • Urinalysis: The physical appearance of urine is assessed, and urine chemical and microscopic analysis is performed.

6) • Microbiology/Parasitology: Identification of pathogenic microorganisms and antibiotic sensitivity testing.

7) • Cytology: Examination of various specimens for abnormal cells, chromosomal studies, Pap smears.

8) • Coagulation: Specimens testing for the presence of various clotting factors.

9) • Histology/Pathology: Tissue samples examined for abnormal function and form.

THE CLINICAL LABORATORY

THE CLINICAL LABORATORY

Definition: A clinical laboratory is any place where specimens from the human body may be collected, processed, examined, or analyzed.

Types of Clinical Laboratory:   

1) Physician office laboratories (POLs).

2) Hospital laboratory

3) Reference laboratory

1)Definition: Physician office laboratories (POLs) are clinical laborato-ries within physician offices where laboratory testing is 

carried out on specimens obtained from the practices’ own patients. 

2) Definition: Hospital laboratories generally offer laboratory testing that meets the needs of their respective institution.For instance, if a hospital specializes in a certain type

of surgical procedure or treatment, the hospital laboratory will offer extensive testing in that specialty area,in addition to the standard tests required to monitor

the health of the other patients in the hospital.

3) Definition: Reference laboratories perform more tests annually than either POLs or the hospital laboratories, processing perhaps thousands of specimens per day. These tests include those that are performed at hospital laboratories,but reference laboratories may offer specialized testing that is not performed at either hospital laboratories or POLs. Specimens may be sent to a reference laboratory from all over the country.

Test performed in different clinical laboratory Explained  :

1) Physician office laboratories (POLs) : These ambulatory (outpatient) laboratories

generally perform low complexity tests that are designated as Clinical Laboratory Improvement Amendment–waived (CLIA-waived) tests by the U.S. Food and Drug Administration (FDA). 

☆ These tests may include the following:

• Rapid microbiology testing for the presence of group A Streptococcus and influenza

• Urine analysis

• Pregnancy testing

• Tests such as those for mononucleosis, Helicobacter pylori, and HIV

• Coagulation testing to monitor patients who are taking anticoagulants

• Glucose levels and other tests used to monitor diabetic patients

• Fecal occult blood tests for the presence of blood in the stool

• Cholesterol testing .

2) Hospital Laboratories : 

☆ Tests performed at a hospital laboratory may include the following:

• Electrolytes

• Kidney function tests

• Liver function analysis

• Blood typing and crossmatches for transfusions

• Identification of microorganisms and antibiotic sensitivity testing.

• Urine analysis

• Coagulation testing

• Cardiac enzyme assays

• Complete blood counts (CBCs) and other hematology testing Hospital laboratories may also offer another method for testing samples, called point-of-care testing

(POCT). Point-of-care tests are actually performed at the patient’s bedside rather than in the laboratory, using a portable instrument that gives immediate results.

3) Reference laboratories : 

   ☆ CLIA-waived tests Moderate- and high-complexity tests . Microscopic examinations.