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ASSIGNMENT

IN

COMMUNITY AND PUBLIC HEALTH

Submitted by:

PARAMIO, MERELL CRISTYN B.

Submitted to:

MRS. SERGIA CACATIAN

Submitted on:

JANUARY 6, 2020
QUESTIONS

1. DESCRIBE THE QUALIFICATIONS AND FUNCTIONS OF THE PERSONNEL

EMPLOYED IN A CLINICAL LABORATORY

The Clinical Laboratory personnel requirements are found in Subpart M of the Code of

Federal Regulations. This subpart addresses qualifications and responsibilities for

Provider Performed Microscopy (PPM), moderate complexity, and high complexity

laboratories. Laboratories performing only waived testing do not have specific personnel

qualifications.

PPM classification has requirements for the laboratory director and testing personnel.

Moderate complexity classification has requirements for the laboratory director, clinical

consultant, technical consultant, and testing personnel.

High complexity classification has requirements for the laboratory director, clinical

consultant, technical supervisor, general supervisor, and testing personnel.

Requirements for a Moderate Complexity Lab

A moderate complexity laboratory is required to have personnel who meet the following

qualifications (in most situations, the laboratory director is qualified to full multiple

roles)

Laboratory Director

Must possess a current license as a laboratory director issued by the state in which the

laboratory is located, if such licensing is required.


Be a doctor of medicine or osteopathy licensed to practice medicine or osteopathy in the

state in which the laboratory is located and be certified in anatomic, clinical pathology, or

both by the American Board of Pathology or the American Osteopathic Board of

Pathology, or possess qualifications that are equivalent.

Hold an earned doctoral degree in a chemical, physical, biological, or clinical laboratory

science from an accredited institution and:

Be certified by the American Board of Medical Microbiology, the American Board of

Clinical Chemistry, the American Board of Bio analysts, or the American Board of

Medical Laboratory Immunology, or

Have at least one-year experience directing or supervising non-waived testing.

Have earned a master’s degree in a chemical, physical, biological, or clinical laboratory

science or medical technology from an accredited institution and:

Have at least one year of laboratory training or experience or both in non-waived testing,

and

In addition, have at least one year of supervisory laboratory experience in non-waived

testing.

Qualified under state law to direct a laboratory in the state in which the laboratory is

located (on or before February 28, 1992).


Technical Consultant

The laboratory must have a technical consultant qualified by education and either training

or experience to provide technical consultation for each of the specialties and

subspecialties tested in the laboratory.

The qualifications include:

Have earned a high school diploma or equivalent, and have documentation of training

appropriate for the testing performed prior to analyzing patient specimens. Such training

must ensure that the individual has:

The skills required for proper specimen collection, including patient preparation, if

applicable, labeling, handling, preservation or fixation, processing or preparation,

transportation and storage of specimens, and

The skills required for implementing all standard laboratory procedures, and

The skills required for performing each test method and for proper instrument use, and

The skills required for performing preventive maintenance, troubleshooting, and

calibration procedures related to each test performed, and

A working knowledge of reagent stability and storage, and

The skills required to implement quality control policies and procedures of the

laboratory, and

An awareness of the factors that influence test results, and the skills required to assess and verify

the validity of patient test results through the evaluation of quality control sample values prior to

reporting patient test.


2. DISCUSS THE BASIC FUNCTIONS OF THE HEMATOLOGY CHEMISTRY (?),

BLOOD BANKING, MICROBIOLOGY, URINALYSIS AND SEROLOGY.

I. HEMATOLOGY - Hematology, also spelled hematology, is the branch of

medicine concerned with the study of the cause, prognosis, treatment, and

prevention of diseases related to blood. It involves treating diseases that affect the

production of blood and its components, such as blood cells, hemoglobin, blood

proteins, bone marrow, platelets, blood vessels, spleen, and the mechanism of

coagulation. Such diseases might include hemophilia, blood clots, other bleeding

disorders and blood cancers such as leukemia, multiple myeloma, and lymphoma.

The laboratory work that goes into the study of blood is frequently performed by a

medical technologist or medical laboratory scientist. Many hematologists work as

hematologist-oncologists, also providing medical treatment for all types of cancer.

The term is from the Greek, haima meaning "blood," and -λoγία meaning study.

II. CLINICAL CHEMISTRY- Clinical chemistry is the area of chemistry that is

generally concerned with analysis of bodily fluids for diagnostic and therapeutic

purposes. It is an applied form of biochemistry.

III. BLOOD BANKING- A blood bank is a center where blood gathered as a result

of blood donation is stored and preserved for later use in blood transfusion. The

term "blood bank" typically refers to a division of a hospital where the storage of

blood product occurs and where proper testing is performed. However, it


sometimes refers to a collection center, and indeed some hospitals also perform

collection.

IV. URINALYSIS-This standard test is usually performed on admission to a hospital

or as part of an annual physical. It may also be done if you have symptoms

relating to abdominal pain or blood in the urine. One to two ounces of urine are

required.

V. SEROLOGY-Serology is the scientific study of serum and other body fluids. In

practice, the term usually refers to the diagnostic identification of antibodies in

the serum. Such antibodies are typically formed in response to an infection,

against other foreign proteins, or to one's own proteins. Serological tests may be

performed for diagnostic purposes when an infection is suspected, in rheumatic

illnesses, and in many other situations, such as checking an individual's blood

type. Serology blood tests help to diagnose patients with certain immune

deficiencies associated with the lack of antibodies, such as X-linked

agammaglobulinemic. In such cases, tests for antibodies will be consistently

negative. Serological methods are diagnostic methods that are used to identify

antibodies and antigens in patients sample which is serum and plasma. There are

some classical serological methods like Agglutination and Precipitation that are

used to identify infectious diseases and human blood grouping typing.


3. DESCRIBE THE APPROPRIATE COLLECTION AND HANDLING OF

SAMPLES ANALYZED IN THE INDIVIDUAL CLINICAL LABORATORY

SECTION

Most often, all that is required is a blood sample. However, samples of urine, saliva,

sputum, feces, semen, and other bodily fluids and tissues also can be tested. Today's

technologies allow testing on an impressively wide variety of samples collected from the

human body.

For some, minor surgery and anesthesia give the health practitioner access to the required

sample. For some samples, they can be obtained as the body naturally eliminates them.

Others are quick and easy to acquire because they reside in the body's orifices.

You may notice on this web site that some tests can be performed on more than one type

of sample. For example, glucose testing can be performed on both blood and urine

samples. However, the sample used for testing is often determined by the purpose of the

particular test: a blood glucose test is used to help diagnose diabetes and monitor blood

glucose levels in diabetics while urine glucose is one of the substances tested when a

urinalysis is performed, such as when a urinary tract infection or kidney disorder is

suspected. Sometimes there are options for the type of sample, such as with HIV antibody

testing (blood, urine, and oral fluid screening tests are available), and in other situations,

one particular type of sample is required.


Samples those are easy to obtain

Some samples are collected by simply running a swab over the affected area. Procedures

of this type can be performed in a clinic, in your doctor's office, or at the hospital

bedside. The sample may be sent to a laboratory for analysis (although a few tests can

provide in-office results in just a few minutes). Throat, nasal, vaginal, and superficial

wound cultures, for example, are obtained in this way. The procedures, while they may

sometimes be uncomfortable, are generally quick, relatively painless, and have no after-

effects.

4. IDENTIFY THE MOST COMMON TEST PERFORMED IN INDIVIDUAL

CLINICAL LABORATORY AND THEIR FUNCTIONS.

Common Lab Tests:

Here is a list of the most common tests ordered and their purposes. Except where noted,

all tests are done using a blood sample.

 ANTINUCLEAR ANTIBODY-This test helps to diagnose lupus and to rule out certain

other autoimmune diseases.

 BASIC METABOLIC PANEL-A group of 7-8 tests used as a screening tool to check

for conditions like diabetes and kidney disease. You may be asked to fast for 10 to 12

hours prior to the test. Determines general health and screens for disorders such as

anemia or infections, as well as nutritional status and toxic substance exposure.


 COMPLETE BLOOD COUNT-This group of 14 tests gives your doctor information

about your kidneys, liver, electrolyte levels, acid/base balance, blood sugar, blood

proteins

 COMPREHENSIVE METABOLIC PANEL-Your doctor may order this test to

determine the cause of inflammation, or to help diagnose and follow the course of joint or

muscle pain.

 SEDIMENTATION RATE-Used to determine whether flu-like symptoms are due to

influenza A or B, or to other causes. Testing may be done using a nasopharyngeal swab,

nasal aspirate or wash, or a throat swab.

 FLU TEST-Used to identify blood glucose level, and to screen for, diagnose, and

monitor diabetes, pre-diabetes, and hypoglycemia. If you are diabetic, glucose levels

should be monitored up to several times a day.

 GLUCOSE LEVEL-Typically performed to confirm and monitor pregnancy, or if

symptoms suggest issues of concern. Urine sample is collected in the morning or a blood

sample is drawn.

 HCG-Used to monitor a person’s diabetes and to aid in treatment decisions, this test is

usually performed with the first diagnosis and then 2 to 4 times per year

 HEMOGLOBIN A1C-This test determines if you are infected with HIV. It should be

performed three to six months after you think you may have been exposed to the virus.

 HIV ANTIBODY TEST-Your liver is the second largest organ in your body. It converts

the food you eat into energy and nutrients and filters waste from your blood. The liver
panel checks the health of your liver and can help diagnose liver damage or disease. This

test can be used to diagnose hepatitis or other liver-related conditions.

 LIVER FUNCTION PANEL-Your liver is the second largest organ in your body. It

converts the food you eat into energy and nutrients and filters waste from your blood. The

liver panel checks the health of your liver and can help diagnose liver damage or disease.

This test can be used to diagnose hepatitis or other liver-related conditions.

 LIPID PANEL-This group of tests can determine risk of coronary heart disease, and

may be a good indicator of whether someone is likely to have a heart attack or stroke, as

caused by blockage of blood vessels.

 LYME ANTIBODY-If you show symptoms of Lyme disease, your doctor may order

this test to see if you have been exposed to Borelli burgdorferi, the bacterium that causes

Lyme disease.

 MICROALBUMIN-This test is performed annually after a diagnosis of diabetes or

hypertension to screen for a possible kidney disorder. It can be done using a random,

timed, overnight, or 24-hour urine sample

 MONONUCLEOSIS TEST-If you have symptoms of mononucleosis, including fever,

sore throat, swollen glands, and fatigue, your doctor may order this test to make a

diagnosis. Should be performed annually for women who are over the age of 18 and/or

sexually active, to screen for cervical cancer and certain vaginal or uterine infections.

Cells are removed from the cervical area for testing.


 PAP SMEAR-Should be performed annually for women who are over the age of 18

and/or sexually active, to screen for cervical cancer and certain vaginal or uterine

infections. Cells are removed from the cervical area for testing.

 PROSTATE SPECIFIC ANTIGEN-This test is to screen for and monitor prostate

cancer.

 PROTHROMBIN TIME-Used to check how well prescribed blood-thinning

medications (anti-coagulants) are working, or to help detect and diagnose a bleeding

disorder.

 PARTIAL THROMBOPLASTIN TIME-This test is most often ordered to help

evaluate your risk of excessive bleeding prior to a surgical procedure, or to monitor

heparin anticoagulant therapy.

 SEMEN ANALYSIS-This test can be used to learn about the health of your reproductive

organs. It can also be performed after a vasectomy to determine if the operation was

successful. A semen sample is collected in a sterile, wide-mouth container provided by

the lab.

 THYROID STIMULATING HORMONE-This test is performed to screen for and

diagnose thyroid disorders, or to monitor treatment of hypothyroidism.

 URINALYSIS-This standard test is usually performed on admission to a hospital or as

part of an annual physical. It may also be done if you have symptoms relating to

abdominal pain or blood in the urine. One to two ounces of urine are required.

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