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clinical laboratory act of 1966
RA 4688
june 18, 1966
june 18, 1966
an act regulating the operation and maintenance of clinical laboratories and requiring the registration of the same with the department of heath thereof, and for other purposes
RA 4688 title
universal health care
offers health care to all and establish referral system to decongest higher/tertiary hospitals
clinical laboratory
a facility where tests are done on specimen taken from human body to obtain information about health status of a patient for prevention, diagnosis, and treatment of disease
clinical chemistry, hematology, immunohematology, microbiology, immunology, clinical microscopy, histopathology, cytology, toxicology, endocrinology, molecular biology, cytogenetics
disciplines in clinical laboratory
government, private
classification of laboratory based on ownership
government laboratory
operated by the national government or local government unit
private laboratory
owned and established by an individual, corporation, association or organization
clinical pathology, anatomic pathology
classification of laboratory based on function
clinical chemistry, hematology, immunohematology, microbiology, molecular biology, clinical microscopy, cytogenetic, toxicology, therapeutic drug monitoring
clinical pathology
surgical pathology, cytology, immunohistopathology, autopsy, forensic pathology, molecular pathology
anatomic pathology
institution based, free standing
classification of laboratories based on institutional character
institution based
operates within the premise of institution such as hospital, school, clinic, medical facility
free standing
not associated with a hospital or other health organization
primary, secondary, tertiary
classification of laboratory based on service capacity
urinalysis, fecalysis, fecal occult blood test, pregnancy test, wet smear for T. vaginalis
services provided by primary lab in clinical microscopy section
fast and random blood sugar, oral glucose tolerance test, lipid profile, creatinine, blood uric acid, blood urea nitrogen
services provided by primary lab in clinical chemistry section
complete blood count
services provided by primary lab in hematology section
dengue, syphilis, hepatitis, HIV screening
services provided by primary lab in Immunology/Serology section
TB tests (direct sputum smear, nucleic acid amplification)
services provided by primary lab in microbiology section
serum electrophoresis, alanine aminotransferase, aspartate aminotransferase, serum glutamic-oxaloacetic transaminase
services provided by secondary lab given those of primary in clinical chemistry section
coagulation studies (prothrombin time, activated partial thromboplastin time)
services provided by secondary lab given those of primary in hematology section
gram staining, KOH
services provided by secondary lab given those of primary in microbiology section
arterial blood gas analysis
services provided by tertiary lab given those of secondary in clinical chemistry section
tumor marker, thyroid function test, hepatitis profile test
services provided by secondary lab given those of secondary in immunology/serology section
culture sensitivity
services provided by secondary lab given those of secondary in microbiology section
assisted in production technology, molecular and cellular technology, molecular biology, molecular pathology, forensics pathology, anatomic pathology
special clinical laboratory
biosafety level 1 laboratory
handles agent that unlikely to cause diseases, personnel required to wear standard PPE such as masks, gloves, laboratory gown
biosafety level 2 laboratory
handles broad spectrum of moderate risk agent associated with diseases with different degrees of severity
biosafety level 3 laboratory
handles indigenous or exotic agents with potential to be transmitted via respiratory routes
biosafety level 4 laboratory
handles extremely dangerous or exotic agent that can be transmitted through air with no available vaccine or therapeutic care
license to operate
issued by BHFS
issue official lab result/receipt, perform other test other than monitoring, cater to other patients
physician office laboratory issued license if:
point-of-care testing
Diagnostic tests done at bedside or near patient care
pathologist
head of laboratory
medical technologist
staff
well lighted, well ventilated, with supply of water
physical facilities
10m square
primary lab size
20m square
secondary lab size
60m square
tertiary lab size
mobile laboratory
permitted to collect specimen only
100km radius
operation of mobile laboratory
october-november
renewal of LTO of non-hospital based laboratory
5 days
processing of LTO should be ___ after expiration
research institute for tropical medicine
national reference laboratory for microbiology
san lazaro hospital
national laboratory for HIV/AIDS, hepatitis, syphilis, and other STIs
east avenue medical center
national reference laboratory for environmental and occupational health, toxicology, and micronutrient assay
national kidney and transplant institute
national reference laboratory for hematology including immunohematology, immunopathology, and anatomic pathology
lung center of the philippines
national reference laboratory for biochemistry
administrative order no. 201 s. 1973
Revised rules & requirements governing the registration, operation, maintenance of clinical laboratories in the Philippines
october 26, 1973
when was AO no. 201 s 1973 approved
administrative order no. 290 s. 1976
Amending Section II Subsection A of Administrative Order No. 201, Series of 1973 Concerning Requirements for a Clinical Laboratory
August 5, 1976
when was AO no. 290 s. 1976 approved
administrative order no. 59 s. 2001
Rules and Regulations Governing the Establishment, Operation and Maintenance of Clinical Laboratories in the Philippines
november 19, 2001
when was AO no. 59 s. 2001
administrative order no. 48 s. 2003
Classification of Clinical Laboratory Based on Institutional Character
may 23, 2003
when was AO no. 48 s. 2003 approved
administrative order no. 2007-0027
Revised Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines
august 22, 2007
when was AO no. 2007-0027 approved
administrative order no. 2007-0027-a
Amendment to Administrative Order No. 2007 – 0027 “Revised Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines”
august 28, 2008
when was AO no. 2007-0027-a approved