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PMLS1: Nature of the Clinical Laboratory Cheat Sheet by

Nature of the Clinical Laboratory

The Clinical Laboratory

Clinical laboratory
essential component of health instit­utions
main task: provide accurate and reliable inform­ation to medical doctors for the diagnosis, prognosis, treatment, and management of diseases
involved in: research, community outreach program, survei­llance, infection control in the hospital and community settings, inform­ation dissem­ina­tion, and evaluation of the applic­ability or current and innovative diagnostic techno­logies
place where specimens (e.g., blood and other body fluids, tissues, feces, hair, nails) collected from indivi­duals are processed analyzed, preserved, and properly disposed.
vary according to size, function, and the complexity of tests performed
Laboratory Test Results
basis for 70% of all decisions performed by medical doctors
Medical Techno­log­ist­/Cl­inical Laboratory Scientist
serves as the integral partner of medical doctors
important member of the health care delivery system
plays a very signif­icant role in the perfor­mance of laboratory testing and ensuring the reliab­ility of test results
Assays in the past: manual, taxing, labor-­int­ensive, and time-c­ons­uming
Presently, with the advent of automa­tion: less laborious, with shortened turn around time (TAT)
Possible cause of changes in the future: shifting demogr­aphics, emergence of new and re-eme­rgence of infectious and non-in­fec­tious diseases, demand for more efficient and effective workflow, and new government instit­utional policies

CCL: According to Functions

Clinical Pathology
focuses in the areas of clinical chemistry, immuno­hem­ato­logy, and blood banking, medical microb­iology, toxico­logy, therap­eutic drug monitory, and endocr­inology
concerned in the diagnosis and treatment of the diseases performed through laboratory testing of blood and other body fluids
Anatomic Pathology
focuses in the areas of histop­ath­ology, immuno­his­top­ath­ology, cytology, autopsy, and forensic pathology
concerned with the diagnostic of diseases through micros­copic examin­ation of tissues and organs

CCL: According to Instit­utional Charac­ter­istics

operates within the premises or part of an instit­ution (e.g., hospital, school, medical clinic, medical facility for overseas workers and seafarers, birthing home, psychi­atric facility, and drug rehabi­lit­ation center)
most common example: Hospit­al-­based clinical labora­tories
not part of an establ­ished instit­ution
Example: free-s­tanding out-pa­tient clinical laboratory

CCL: According to Ownership

owned, wholly or partially, by national or local government units
Examples: clinical and anatomical labora­tories of DOH-run government hospitals (San Lazaro Hospital, Jose R. Reyes Memorial Medical Center, University of the Philip­pin­es-­Phi­lippine General Hospital and local govern­men­t-run hospit­al-­based clinical labora­tories of the Ospital ng Maynila Medical Center, Sta. Ana Hospital, and Bulacan Medical Center)
owned, establ­ished, and operated by an indivi­dual, corpor­ation, instit­ution, associ­ation, or organi­zation
Examples: St. Luke's Medical Center, Makati Medical Center, and MCU-FDTMF Hospital

CCL: According to Service Capability

Primary category
licensed to perform routine laboratory testing (e.g., routine urinalysis and routine stool examin­ation)
routine hematology or complete blood count: hemogl­obin, hemato­crit, WBC and RBC count, WBC differ­ential count and qualit­ative platelet count, blood typing, and Gram staining (if hospit­al-­based)
Equipment: micros­copes, centri­fuge, and hematocrit centrifuge
Space requir­ement: at least 10 square meters
Secondary category (Hospital and non-ho­spi­tal­-based)
licensed to perform laboratory tests being done by the primary category clinical labora­tories along with routine clinical chemistry tests
routine chemical chemistry tests: blood glucose concen­tra­tion, blood urea nitrogen, blood uric acid, blood creati­nine, choles­terol determ­ina­tion, and qualit­ative platelet count
If hospit­al-­based: Gram stain, KOH mount, and cross-­mat­ching
Minimum requir­ement: 20 square meters floor area
Personnel requir­ement: depends on the workload
Equipment: micros­cope, centri­fuge, Hematocrit centri­fuge, semi-a­uto­mated chemistry analyzers, autoclave, incubator, and oven
Tertiary category (Hospital and non-ho­spi­tal­-based)
licensed to perform all the laboratory tests performed in the secondary category laboratory
Immunology and serology: NS1-Ag for dengue, rapid plasma reagin, and Treponema pallidum particle agglut­ination tests
Microb­iology, bacter­iology, and mycology: differ­ential staining techni­ques, culture and identi­fic­ation of bacteria and fungi from specimens, and antimi­crobial suscep­tib­ility testing
Special clinical chemistry: clinical enzymo­logy, therap­eutic drug monito­ring, and markers for certain diseases
Special hemato­logy: bone marrow studies, special staining for abnormal blood cells, and red cell orphology
Immuno­hem­atology and blood banking: blood donation program, antibody screening and identi­fic­ation, and prepar­ation for blood components
Minimum floor requir­ement: at least 60 square meters
Equipment: micros­cope, centri­fuge, Hematocrit centri­fuge, semi-a­uto­mated chemistry analyzers, autoclave, incubator, oven, automated chemistry analyzer, biosafety cabinet class II, and serofuge
National Reference Laboratory
laboratory in a government hospital designated by the DOH
provide special diagnostic functions and services for certain diseases
Functions: Referral services, provision of confir­matory testing, assistance for research activi­ties, implem­ent­ation of External Quality Assurance Programs (EQAP) of the govern­ment, resolution of conflicts regarding test results of different labora­tories, and training of medical techno­logists on certain specia­lized procedures that requires standa­rdi­zation

Republic Act No. 4688

June 18, 1966

Sections of the Clinical Laboratory

Clinical laboratory
made up of different sections cohesively and compre­hen­sively performing different activities and procedures for each specimen collected from patient to produce reliable test results
Clinical laboratory personnel: pathol­ogists, medical techno­log­ist­s/c­linical laboratory scient­ists, medical techni­cians, phlebo­tom­ists, and other laboratory personnel
Clinical Chemistry
intended for testing blood and other body fluids to quantify essential soluble chemicals including waste products useful for diagnosis of certain diseases
Most common body fluids: blood and urine
Test Performed: fasting blood sugar (FBS), glycos­ylated hemoglobin (HbA1c - diabetes), total choles­terol - HDL and LDL, trigly­cerides (TAG) - cardio­vas­cular diseases, blood uric acid (BUA), blood urea nitrogen (BUN), creatinine - diseases involving the kidney, total protein (TP), albumin, electr­olytes (sodium, potassium, chloride), clinical enzymology (amino­tra­nsf­erase and creatine kinase)
One of the busiest sections of the clinical laboratory
charac­terized as state-­of-art, fully automated facility
Endocr­ino­logy: hormone in blood and urine
Thyroid hormone tests: thyroid stimul­ating hormone (TSH), T3 and T4 (triio­dot­hyr­onine and thyroxine)
Other tests: estrogen, prolactin, and testos­terone
Other labora­tories: Toxicology and Drug Testing
Important activi­ties: Internal Quality Assurance (IQA), Continuous Quality Improv­ement (CQA), and partic­ipation in National External Quality Assurance Program (NEQAP)
Four major sections: bacter­iology, mycoba­cte­rio­logy, mycology, and virology
focused on the identi­fic­ation on bacteria and fungi on specimens received
Specimens: blood and other body fluids, stool, tissues, and swabs
Tests: micros­copic visual­ization of microo­rga­nisms after staining, isolation, and identi­fic­ation of bacteria (aerobes and anaerobes) and fungi using varied culture media and different bioche­mical tests (antigen typing and antiba­cterial suscep­tib­ility testing)
Other activi­ties: prepar­ation of culture media and stains, quality assurance and control, infection control, and biosafety and proper waste disposal
Mycoba­cte­rio­logy: identi­fic­ation of mycoba­cterium (e.g., Mycoba­cterium tuberc­ulosis)
Hematology and Coagul­ation Studies
enumer­ation of cells in the blood and other body fluids (CSF and pleural fluid)
Examin­ations: CBC, hemogl­obin, hemato­crit, WBC differ­ential count, red cell morpho­logy, total cell count and differ­ential count, blood smear prepar­ation, and staining for other body fluids
Coagul­ation studies: focuses on blood testing for determ­ination of various coagul­ation factors
Bone marrow examin­ation: performed in automated hematology analyzers
Clinical Microscopy
First Area: allotted to routine and other special examin­ations of urine (macros­copic examin­ation: determine the color, transp­arency, specific gravity, and pH level and micros­copic examin­ation: detect the presence of abnormal cells and/or parasites as well as to quantify red cells and WBC and other chemicals found in urine
Second Area: examin­ation of stool or routine fecalysis
Routine fecalysis: identi­fic­ation of parasitic worms and ova
Blood Bank/I­mmu­noh­ema­tology
screening for all antibodies and identi­fic­ation of antibodies and blood components used for transf­usion
Tests: blood typing and compat­ibility testing
most critical in the clinical laboratory
Hospit­al-­based clinical labora­tories: blood donation activities (donor recrui­tment and screening, bleeding of donor, and post-d­onation care
Immunology and Serology
analyses of serum antibodies in certain infectious diseases (primarily viral agents)
Tests: Hepatitis B profile tests, serolo­gical tests for syphilis
Antibody screening tests: test for hepatitis C and dengue fever
Automated analyzers are also used in this section for different serolo­gical tests
Anatomic Pathology: Section of Histop­ath­olo­gy/­Cyt­ology
Activi­ties: tissue processing (removed surgic­ally: biopsy­/au­topsy), cutting into sections, staining, and prepar­ation for micros­copic examin­ation by a pathol­ogist
Specia­lized Sections of the Labora­tory: Immuno­his­toc­hem­istry
combines anatom­ical, clinical, and bioche­mical techniques where antibodies (monoc­lonal and polycl­onal) bounded to enzymes and fluore­scent dyes are used to detect presence of antigens and tissue
useful in the diagnosis of some types of cancers by detecting the presence of tumor-­spe­cific antigens, oncogenes, and tumor suppressor genes.
assess the responses of patients to cancer therapy as well as diagnosis for certain neurod­ege­ner­ative disorders
Molecular Biology and Biotec­hnology
uses different enzymes and other reagents, DNA and RNA are identified and sequenced to detect any pathologic condit­ion­s/d­isease processes
Most common technique: polymerase chain reaction (PCR) - contri­buted to scientific advanc­ements in laboratory research; useful for clinical techniques (screening genetic indicators of disease & diagnosis of cancer and infectious diseases

Laboratory Testing Cycle

Laboratory Testing Cycles
encomp­asses all activities starting from the medical doctor writing a laboratory request up to the time (called the turnaround time [TAT]) the results are generated and become useful inform­ation for the treatment of patients
Three phases: pre-an­alytic, analytic, and post analytic
Pre-an­alytic phase: receipt of laboratory request, patient prepar­ation, specimen collec­tion, and proper transport and processing of specimen to the clinical laboratory
Analytic phase: actual testing of the submit­ted­/co­llected specimen
Equipment and instru­ments: reagents and internal quality control program
Post-a­nalytic phase: transm­ission of test results to the medical doctor for interp­ret­ation, TAT, and applic­ation of doctor's recomm­end­ations; diagnosis and treatments are based in the generated data
Medical Techno­log­ist­/Cl­inical Laboratory Scientist
Must have clear unders­tanding of the testing cycle to avoid erroneous test results
variables may affect the tests results: prepar­ation of the request slip for the patient
variables that may cause errors: physio­logical factors, diet, medica­tions, alcohol and caffeine intake, exercise, underlying disease condit­ions, identi­fic­ation of patients and labeling of specimens, antico­agulant used, and volume of specimen collected vis-a-vis volume of antico­agulant
Post-a­nalytic phase: control of the variables of TAT and transc­ription errors (e.g., wrong value used, result given to the wrong patient).

Quality Assurance in the Clinical Laboratory

Quality Assurance
encomp­asses all activities performed by laboratory personnel to ensure reliab­ility of test results
organized, system­atic, well-p­lanned, and regularly done with the results properly documented and consis­tently reviewed
Two Major Components
Internal Quality Assurance System (IQAS) and External Quality Assurance System (EQAS)
Internal Quality Assurance System (IQAS)
day-to-day activities that are undertaken in order to control factors or variables that may affect test results
Regular review and audit of test results: done to identify weaknesses and conseq­uently perform corrective actions
External Quality Assurance System (EQAS)
system for checking perfor­mance among clinical labora­tories and is facili­tated by designated external agencies
National Reference Labora­tories (NRL): DOH-de­sig­nated EQAS
Unknown sample with known test results -> clinical laboratory for testing -> results returned to external facility -> compared to the known result (deter­mines the perfor­mance of the labora­tory)
Certif­icate of Perfor­mance
given to the partic­ipating clinical laboratory
Designated NRL-EQAS
National Kidney and Transplant Institute (NKTI) - Hematology and Coagul­ation
Research Institute of Tropical Medicine (RITM) - Microb­iology (ident­ifi­cation and antibiotic suscep­tib­ility testing) and Parasi­tology (ident­ifi­cation of ova and quotation malaria)
Lung Center of the Philip­pines (LCP) - Clinical chemistry (for testing 10 analytes, namely glucose, creati­nine, total protein, albumin, blood urea nitrogen, uric acid, choles­terol, sodium, potassium, and chlorine
East Avenue Medical Center (EAMC) - Drug of abuse (metha­mph­etamine and cannab­inoids)
San Lazaro Hospital STD-AIDS Cooper­ative Center Laboratory (SACCL) - Infectious immunology hepatitis B surface antigen (HBsAg), human immuno­def­iciency virus (HIV), Hepatitis C virus (HCV)


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