Chapter 2: AO no. 2021-0037 Flashcards
It refers to any natural juridical person, government instrumentalities/agencies, partnership, corporation, or agency seeking a license to operate and maintain a clinical laboratory.
Applicant
The checklist which prescribes the minimum standards and requirements for licensure of a clinical laboratory.
Assessment tool
A facility that is involved in the (a) pre-analytical, (b) analytical, (c) and post-analytical procedures, 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.
These tests include, but are not limited to, the following disciplines:
- Anatomic pathology
- Clinical chemistry
- Clinical microscopy
- Endocrinology
- Hematology
- Immunology and serology
- Microbiology
- Toxicology
- Molecular and nuclear diagnostics
Clinical Laboratory
A formal authorization issued by the DOH to an individual, partnership, corporation, association, or any government agency/unit seeking to perform laboratory tests in compliance with the requirements prescribed in this Order.
Department of Health - Permit to Construct (DOH-PTC)
A program where participating CL are given unknown samples for analysis.
These samples should be treated as ordinary human specimens for the usual processing and examination.
External Quality Assessment Program (EQAP)
A laboratory testing unit capable of performing limited CL diagnostic procedures. It moves from one testing site to another, and it has a DOH-licensed CL as its main laboratory.
Mobile Clinical Laboratory (MCL)
It refers to applications by newly constructed health facilities, or those with changes in the circumstances of the facility, such as, but not limited to, change of ownership, transfer of site, increase in beds, or additional services beyond their service capability and major alterations or renovations.
Initial application
An EQAP activity was conducted by the National Reference Laboratories to assess the quality of performance and accuracy of the results of laboratories.
National External Quality Assessment Scheme (NEQAS)
The highest level of laboratory in the country performs highly complex procedures, including confirmatory testing, that are not commonly performed by the lower-level of laboratory.
National Reference Laboratory (NRL)
It refers to diagnostic testing done at or near the site of patient care rather than in the CL.
It may be in the emergency room, operating suites,
wards, and ambulances.
Point of Care Testing (POCT)
It refers to a doctor’s office/clinic wherein CL examinations are performed for the purpose of monitoring the doctor’s patients only, wherein NO official results shall be issued.
Physician’s Office Laboratory (POL)
It refers to an extension of the main CL located within the facility’s compound or premises. It shall have the same service capability as the main laboratory.
Satellite Clinical Laboratory (SCL)
It refers to CL tests that are either sent out or outsourced to other DOHlicensed CLs with the same or higher service capability
Referral test
What are the TWO classifications by OWNERSHIP?
- Government
- Private
It is established, and operated with funds through donation, principal, investment, or other means, by any individual, corporation, association, or organization
Private
It is operated and maintained, partially or wholly, by the national government, a local government unit (provincial, city, or municipal), any other political unit, or any department, division, board, or agency thereof.
Government
What are the TWO classifications by Institutional Character?
- Institution-based
- Non-institution based
A laboratory that is located within the premises and operates as part of a DOH-licensed health facility
Institution-based
A laboratory that operates independently and is not attached to any DOH-licensed health facility.
Non-institution based
What are the THREE classifications by Function?
- Clinical Pathology
- Anatomic Pathology
- Molecular Pathology
It deals with the chemical and cellular analyses of blood and other body fluids.
- Clinical chemistry
- Clinical microscopy
- Toxicology
- Therapeutic drug monitoring
- Immunology and serology
- Hematology and coagulation
- Identification and examination of microbes and parasites
- Bacteriology
- Parasitology
- Mycology & Virology
Clinical Pathology
It provides processing and examination of surgical specimens as to the physical appearance and microscopic structure of tissues
- Surgical pathology
- Cytopathology,
- Immunohistochemical techniques
- Autopsies
- Forensic pathology.
Anatomic Pathology
It deals with the analysis of certain genes, proteins, and other molecules in samples from organs, tissues, or bodily fluids in order to diagnose disease and/or to guide the prevention and treatment of disease based on the principles, techniques, and tools of molecular biology as they are applied to diagnostic medicine in the laboratory
Molecular Pathology
Give at least procedural guidelines.
- Permit to construct
- License to operate
- Certificate of registration
- Validity
- Fees
- Monitoring
