Overview of the Clinical Lab Flashcards
Is a facility for the biological, microbiological serological, chemical immunohematological, hematological, biophysical, cytological pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of human beings.
Clinical Laboratory Improvement Amendments (CLIA) of 1988
An Act Regulating the Operation and Maintenance of Clinical Laboratories and Requiring the Registration of the Same with the Department of Health, Providing Penalty for the Violation Thereof and for other Purposes
Republic Act No. 4688 Clinical Laboratory Act of 1966
Revised Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines.
DOH Administrative Order No. 2007-0027
A facility where tests are done on specimens from the human body to obtain information about the health status of a patient for the prevention, diagnosis, and treatment of diseases;
The Clinical Laboratory
A facility where tests are done on specimens from the human body to obtain information about the health status of a patient for the prevention, diagnosis, and treatment of diseases;
The Clinical Laboratory
THE TESTING PROCESS
Collection of the specimen
Testing of the specimen
Releasing of the lab results
Other Functions of clinical lab
Provides consultative advisory services covering all aspects of laboratory investigation including the interpretation of results and advice on the further appropriate investigation or system.
occurs first in the laboratory process.
Pre-analytical
“testing phase” – monitor, evaluate, and maintain this phase for an accurate and precise result.
Analytical
The post-analytic phase is the final phase of the laboratory process.
This phase culminates in the production of a final value, result, or the case of histology, a diagnostic pathology report.
Post-analytical
Determine the phase
Selection of the assay/test relative to the patient needs
Pre
Determine the phase
Implementation of assay/test selection
Pre
Determine the phase
Patient identification and preparation
Pre
Determine the phase
Specimen collection (blood collection)
Pre
Determine the phase
Specimen transport, preparation, storage
Pre
Determine the phase
Monitoring of specimen condition.
Pre
Enumerate all the pre analytical variables
Selection of the assay/test relative to the patient needs
Implementation of assay/test selection
Patient identification and preparation
Specimen collection (blood collection)
Specimen transport, preparation, storage
Monitoring of specimen condition.
Enumerate all the analytical variables
Instrument selection
Equipment selection
Assay/test validation
Laboratory staff competence
External and Internal quality control
Quality control test- run the machine for testing.
Determine the phase
Instrument selection
anal
Determine the phase
Equipment selection
anal
Determine the phase
Assay/test validation
anal
Determine the phase
Laboratory staff competence
anal
Determine the phase
External and Internal quality control
anal
Determine the phase
Quality control test- run the machine for testing.
anal
TAT stands for
Turn around time
Enumerate all the post-analytical variables
TAT
Accuracy and transcription and filing of test results.
Content and format of lab report
Timeliness in communicating test critical values to patient and physician.
*critical value – the value of something that is far away or less than the normal range value.
Determine the phase
TAT
post
Determine the phase
Accuracy and transcription and filing of test results.
post
Determine the phase
Content and format of lab report
post
Determine the phase
Timeliness in communicating test critical values to patient and physician.
post
Determine the phase
*critical value – the value of something that is far away or less than the normal range value.
post
A laboratory testing unit that moves from the testing site to another testing site or has a temporary testing location. It shall have a base laboratory.
The Mobile Clinical Laboratory
Annual Physical Exam for their employees
*Health Caravan
offers a variety of testing, and is also involved in Health Caravan, so, it’s considered Mobile Clinical Lab. (example of mobile clinical lab)
“Health First” of UNILAB
Any testing site that performs laboratory examinations under the administrative control of a licensed laboratory but performed outside the physical confines of that laboratory.
The Satellite Testing Site
An individual doctor’s office or clinic wherein laboratory examinations are performed:
THE PHYSICIAN’S OFFICE LABORATORY
A diagnostic testing at or near the site of patient care rather than in the clinical laboratory. It includes bedside testing, outpatient, and home care.
Point of Care Testing (POCT)
A laboratory in a government hospital designated by the DOH to provide special functions and services for specific disease areas. It may or may not be a part of a general Clinical Laboratory.
THE NATIONAL REFERENCE LABORATORY
NRL. for Environmental and Occupational Health, Toxicology and Micronutrient Assay with location
East Avenue Medical Center, Diliman, Quezon City
RL for Hematology, including Immunohematology with location
National Kidney and Transplant Institute, Diliman, Quezon City
RL for HIV-AIDS. Hepatitis, and Sexually Transmitted Diseases (Venereal Diseases) with location
San Lazaro Hospital, Santa Cruz, Manila
HIV and AIDS
Human Immunodeficiency Virus
Acquired Immunodeficiency Syndrome
group of signs and syndromes associated with each other.
syndrome
NRL for Anatomic Pathology and Biochemistry with location
Lung Center of the Philippines, Quezon City
NRL for Dengue, Influenza, TB and other Mycobacteria, Malaria and other Parasites, Bacterial Enteric Diseases, Measles and other Viral Exanthems, Mycology, Enteroviruses, Antimicrobial Resistance and Emerging Diseases for Confirmatory Testing of Blood Donors and Units
Research Institute for Tropical Medicine
The basic commonly requested tests in the laboratory the results of which are not required to be released immediately upon completion it shall follow the usual procedures and systems in the laboratory
Routine Tests
Tests done on urgent cases the results of which shall be released immediately within an hour or less after the procedure STAT “sta’tim” - immediately”
The STAT Tests
Classification of Clinical Laboratories
By Ownership
By Function
By Institutional Character
By Service Capability
Classification by Ownership
Government and Private
operated and maintained, partially or wholly, by the national government, a local government unit (provincial city, or municipal, or any other political unit or department. division board or agency.
Government
owned, established and operated by any individual, corporation, association, or organization.
Private
Example of private laboratories
The Medical City, St. Paul Hospital, St. Luke’s Medical Hospitals
Example of government laboratories
Philippine General Hospital, Cagayan Valley Medical Center, Tuguegarao City People’s General Hospital, Rural Health Unit
Classification by Function
Anatomic Pathology
Clinical Pathology
includes clinical chemistry, hematology, and immunohematology. microbiology immunology, clinical microscopy. endocrinology, molecular biology. cytogenetics, toxicology, therapeutic drug monitoring, and similar disciplines.
Clinical Pathology
includes surgical pathology, immunohistopathology, and cytology.
Anatomic Pathology
Classification by Institutional Character
Institution-Based
Free-Standing
a laboratory that does not form part of any other institution
Free-Standing
examples of Free-Standing labs
Immaculate Heart Diagnostic Laboratory. Trimedica Laboratory
Example of Institution-Based labs
CVMC Department of Laboratory, RPGMC
a laboratory that operates within the premise and as part of an institution, such as but not limited to hospital, medical clinic, school, a medical facility for overseas workers and
Institution-Based
Routine Hematology (Complete Blood Count) - includes the hemoglobin mass concentration, erythrocyte volume fraction, leukocyte number concentration, and leukocyte type number fraction;
Qualitative platelet count;
Routine Urinalysis;
Routine Fecalysis;
Quantitative platelet count and Blood Typing - if hospital-based
Primary Category
Routine Clinical Chemistry - includes blood glucose concentration, blood urea nitrogen, blood uric acid, blood creatinine, and total cholesterol;
Cross-matching, Gram-staining, and Potassium Hydroxide Test - if hospital based
Example - Tuguegarao City People’s General Hospital, Holy Infant Hospital Department of Laboratory, Clinica de Leon Laboratory
Secondary Category
Special chemistry;
Special hematology, including coagulation procedures;
Immunology:
Microbiology - culture and sensitivity testing (aerobic and anaerobic if hospital-based); aerobic or anaerobic if non-hospital-based
Example - CVMC Department of Laboratory, RPGMC Department of Pathology and Laboratory, Saint Paul Hospital Laboratory
Limited Service Capability - provides the laboratory tests required for a particular service in institutions such as but not limited to dialysis centers and social hygiene clinics
Tertiary Category
Classification by Sevice Capability
General and Special Clinical Laboratory
