PMODULE 1 DORADO, R.A.

INTRODUCTION TO CLINICAL CHEMISTRY

Laboratory Medicine Special Chemistry

 refers to the discipline involved in the selection,
provision, and interpretation of diagnostic testing that
uses samples from patients. Those active in the field
participate in:
 analytical testing
 research
 administration
 teaching activities, and
 clinical service to varying degrees.
Clinical Chemistry
 quantitative science that is concerned with
measurement of amounts of biologically important
substances (called analytes) in body fluids. The
methods to measure these substances are carefully
designed to provide accurate assessments of their
concentration. The results of clinical chemistry tests
are compared to reference intervals or a medical
decision level (MDL) to provide diagnostic and clinical
meaning for the values.
HISTORY
 The first laboratory attached to a hospital was
established in 1886 in Munich, Germany, by Hugo
Wilhelm von Ziemssen.
 In the United States, the first clinical laboratory was
The William Pepper Laboratory of Clinical Medicine,
established in 1895 at the University of Pennsylvania
in Philadelphia.
 The first Clinical Laboratory in the Philippines was
established in QUIRICADA ST., Sta. CRUZ, MANILA
(MANILA PUBLIC HEALTH). The lab offered training
programs to high school graduates as early as
FEBRUARY,1944.
USES OF TESTING IN THE CLINICAL LABORATORY
 Confirming a clinical suspicion (which could include
making a diagnosis)
 Excluding a diagnosis
 Assisting in the selection, optimization, and
monitoring of treatment
 Providing a prognosis
 Screening for disease in the absence of clinical signs or
symptoms
 Establishing and monitoring the severity of a
physiologic disturbance
 elaborate techniques such as electrophoresis, and
manual testing methods.
Clinical Endocrinology
 the study of hormones, and diagnosis of endocrine
disorders.
Toxicology
 the study of drugs of abuse and other chemicals.
Therapeutic Drug Monitoring
 measurement of therapeutic medication levels to
optimize dosage.
Urinalysis
 chemical analysis of urine for a wide array of diseases,
along with other fluids such as CSF and effusions
Fecal Analysis
 mostly for detection of gastrointestinal disorders.
WHAT ARE THE DIFFERENT TYPES OF LABORATORY TESTS?
Clinical chemistry uses chemical processes to measure
levels of chemical components in body fluids and tissues. The
most common specimens used in clinical chemistry are:
 blood, and
 urine.
Many different tests exist to detect and measure
almost any type of chemical component in blood or urine.
Components may include:
 blood glucose
 electrolytes
 enzymes
 hormones
 lipids (fats)
 other metabolic substances, and
 proteins.
FLUIDS TYPICALLY USED FOR CLINICAL CHEMISTRY TESTS
 Blood (whole blood, serum or plasma)
 Urine Cerebrospinal fluid (CSF)
 Amniotic fluid
 Saliva
 Synovial fluid (fluid that is found in joint cavities)
 Pleural fluid (from the sac surrounding the lungs)
 Pericardial fluid (from the sac surrounding the heart)
 Peritoneal fluid (also called ascitic fluid; from the
abdomen)

ETHICAL ISSUES IN CLINICAL CHEMISTRY AND MOLECULAR

DIAGNOSTICS
 Confidentiality of genetic information
 Confidentiality of patient medical information
 Allocation of resources
 Codes of conduct
 Publishing issues
 Conflicts of interest

CLINICAL CHEMISTRY SUB-SPECIALTIES

General or Routine Chemistry
 commonly ordered blood chemistries (e.g., liver and
kidney function tests).
COMMON ANALYTES IN THE CLINICAL CHEMISTRY LABORATORY PANEL ANALYTES PURPOSE OF
Clinical chemistry is the branch of laboratory medicine TESTING
that focuses primarily on molecules. The tests in a clinical Lipid Profile -Total Cholesterol For the assessment
chemistry laboratory measure concentration of biologically -LDL Cholesterol of:
important ions (salts and minerals), small organic molecules and -HDL Cholesterol -any cardiovascular
-Triglycerides related disorders
large macromolecules (primarily proteins). *hypertension
*atherosclerosis
Basic -Sodium (Na) For the assessment
-Potassium (K) of:
Metabolic -Chloride (Cl) -fluid balance
Panel -Carbon Dioxide (CO2) -electrolyte balance
-Glucose -glucose level
-Creatinine -kidney function
-Chloride (Cl)
-Urea (blood urea nitrogen;
BUN)
Comprehensive -Sodium (Na) For the assessment
-Potassium (K) of:
Metabolic -Chloride (Cl) -fluid balance
Panel -Carbon Dioxide (CO2) -electrolyte balance
-Glucose -glucose level
-Creatinine -kidney function
-Urea -liver functions
-Calcium
-Total Protein
-Albumin
-Alanine
-Aminotransferase (ALT)
-Aspartate
-Aminotransferase (AST)
-Alkaline
-Phosphatase (AlkP)
-Total Bilirubin

Liver Function -Albumin Total Protein For the assessment

-Alkaline Phosphatase of:
Tests -Alanine -liver disorders
-Aminotransferase (ALT) *hepatitis
-Aspartate *HDN
-Aminotransferase (AST) *liver cancer
-Total Bilirubin *gallstones
-Direct Bilirubin
Electrolyte -Sodium (Na) To assess:
-Potassium (K) -fluid balance
Panel -Chloride (Cl) -electrolyte balance
-Carbon Dioxide (CO2)
 MODULE 1 DORADO, R.A.

LABORATORY SAFETY, BIOSAFETY AND WASTE MANAGEMENT

Safety procedure manuals must be readily available
in the laboratory that describe the safety policies mandated
by the Centers for Disease Control and Prevention (CDC) and
the Occupational Safety and Health Administration (OSHA),
and strict adherence to these guidelines by laboratory
personnel is essential. The manual must be updated and
reviewed annually by the laboratory director. The Clinical
and Laboratory Standards Institute (CLSI) provides the
guidelines for writing these procedures and policies.
A) LABORATORY SAFETY AND REGULATIONS
Public Law 91-596, better known as the Occupational
Safety and Health Act (OSHA)
 was enacted by the U.S. Congress in 1970. The goal
of this federal regulation was to provide all
employees (clinical laboratory personnel included)
with a safe work environment.
Bloodborne Pathogens [29 CFR 1910.1030]
 applies to all exposure to blood or other potentially
infectious materials in any occupational setting.
Hazard Communication [29 CFR 1910.1200]
 subpart to OSHA’s Toxic and Hazardous Substances
regulations, intended to ensure that the hazards of
all chemicals used in the workplace have been
evaluated and that this hazard information is
successfully transmitted to employers and their
employees who use the substances. Informally
referred to as the OSHA “HazCom Standard”.
Occupational Exposure to Hazardous Chemicals in
Laboratories [29 CFR 1910.1450]
 second subpart to OSHA’s Toxic and Hazardous
Substances regulations, also known as the “OSHA
Lab Standard.” It was intended to address the
shortcomings of the Hazard Communication
Standard regarding its application peculiar to the
handling of hazardous chemicals in laboratories,
whose multiple small-scale manipulations differ
from the industrial volumes and processes targeted
by the original HazCom Standard.
C) SAFETY AWARENESS FOR CLINICAL LABORATORY
PERSONNEL
a) SAFETY RESPONSIBILITY
Employer’s Responsibilities
 Establish laboratory work methods and safety
policies.
 Provide supervision and guidance to employees.
 Provide safety information, training, PPE, and
medical surveillance to employees.
 Provide and maintain equipment and laboratory
facilities that are free of recognized hazards and
adequate for the tasks required.
Employee’s Responsibilities
 Know and comply with the established laboratory
safe work practices.
 Have a positive attitude toward supervisors,
coworkers, facilities, and safety training.
 Be alert and give prompt notification of unsafe
conditions or practices to the immediate supervisor
and ensure that unsafe conditions and practices are
corrected.
 Engage in the conduct of safe work practices and use
of PPE.
b) SIGNAGE AND LABELING
National Fire Protection Association (NFPA)
 developed a standard hazard identification system
(diamond-shaped, color-coded symbol), which has
been adopted by many clinical laboratories. At a
glance, emergency personnel can assess health
hazards (blue quadrant), flammable hazards (red
quadrant), reactivity/stability hazards (yellow
quadrant), and other special information (white
quadrant). In addition, each quadrant shows the
magnitude of severity, graded from a low of 0 to a
high of 4, of the hazards within the posted area.

B) OTHER REGULATIONS AND GUIDELINES

Clinical and Laboratory Standards Institute (CLSI, formerly
National Committee for Clinical Laboratory Standards
[NCCLS])
 provides excellent general laboratory safety and
infection control guidelines in their documents
GP17-A2 (Clinical Laboratory Safety; Approved
Guideline, Second Edition) and M29A3 (Protection of
Laboratory Workers from Occupationally Acquired
Infections; Approved Guideline, Third Edition).
The Joint Commission (TJC; formerly the Joint Commission
on Accreditation of Health Care Organizations [JCAHO])
 publishes a yearly accreditation manual for hospitals
and the Accreditation Manual for Pathology and
Clinical Laboratory Services, which includes a
detailed section on safety requirements.
College of American Pathologists (CAP)
 publishes an extensive inspection checklist
(Laboratory General Checklist) as part of their
Laboratory Accreditation Program, which includes a
section dedicated to laboratory safety.
 A) SAFETY EQUIPMENT C) CHEMICAL SAFETY
 All laboratories are required to have safety showers, Hazard Communication
eyewash stations, and fire extinguishers and to  in the August 1987 issue of the Federal Register,
periodically test and inspect the equipment for OSHA published the new Hazard Communication
proper operation. Standard (Right to Know Law, 29 CFR 1910.1200).
 Safety showers must deliver 30 to 50 gallons of
water per minute at 20 to 50 pounds per square inch
(psi) and be located in areas where corrosive liquids
are stored or used.
 Eyewash stations must be accessible (i.e., within 100
feet or 10 s travel) in laboratory areas presenting
chemical or biological exposure hazards.
 Other items that must be available for personnel
include fire blankets, spill kits, and first aid supplies.
 Mechanical pipetting devices must be used for
manipulating all types of liquids in the laboratory,
including water.
 Mouth pipetting is strictly prohibited.
Chemical Fume Hoods
 required to contain and expel noxious
and hazardous fumes from chemical
reagents.
Biosafety Cabinets Fume Hoods (BSCs)
 remove particles that may be harmful to
the employee who is working with
potentially infectious biologic
specimens.
 The Centers for Disease Control and
Prevention (CDC) and the National
Institutes of Health have described four
levels of biosafety, which consist of
combinations of laboratory practices and
techniques, safety equipment, and
laboratory facilities.

High-efficiency Particulate Air (HEPA), also known

as High-efficiency Particulate Absorbing and High-
efficiency Particulate Arrestance
 an efficiency standard of air filter.

Chemical Storage Equipment Safety equipment

 available for the storage and handling of
hazardous chemicals and compressed
gases.
PPE and Hygiene

B) BIOLOGIC SAFETY
 Spills
 Bloodborne Pathogens
 Airborne Pathogens
 Shipping