Clinical Laboratory Law

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62 Terms

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clinical laboratory act of 1966

RA 4688

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june 18, 1966

june 18, 1966

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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

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universal health care

offers health care to all and establish referral system to decongest higher/tertiary hospitals

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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

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clinical chemistry, hematology, immunohematology, microbiology, immunology, clinical microscopy, histopathology, cytology, toxicology, endocrinology, molecular biology, cytogenetics

disciplines in clinical laboratory

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government, private

classification of laboratory based on ownership

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government laboratory

operated by the national government or local government unit

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private laboratory

owned and established by an individual, corporation, association or organization

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clinical pathology, anatomic pathology

classification of laboratory based on function

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clinical chemistry, hematology, immunohematology, microbiology, molecular biology, clinical microscopy, cytogenetic, toxicology, therapeutic drug monitoring

clinical pathology

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surgical pathology, cytology, immunohistopathology, autopsy, forensic pathology, molecular pathology

anatomic pathology

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institution based, free standing

classification of laboratories based on institutional character

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institution based

operates within the premise of institution such as hospital, school, clinic, medical facility

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free standing

not associated with a hospital or other health organization

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primary, secondary, tertiary

classification of laboratory based on service capacity

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urinalysis, fecalysis, fecal occult blood test, pregnancy test, wet smear for T. vaginalis

services provided by primary lab in clinical microscopy section

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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

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complete blood count

services provided by primary lab in hematology section

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dengue, syphilis, hepatitis, HIV screening

services provided by primary lab in Immunology/Serology section

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TB tests (direct sputum smear, nucleic acid amplification)

services provided by primary lab in microbiology section

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serum electrophoresis, alanine aminotransferase, aspartate aminotransferase, serum glutamic-oxaloacetic transaminase

services provided by secondary lab given those of primary in clinical chemistry section

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coagulation studies (prothrombin time, activated partial thromboplastin time)

services provided by secondary lab given those of primary in hematology section

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gram staining, KOH

services provided by secondary lab given those of primary in microbiology section

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arterial blood gas analysis

services provided by tertiary lab given those of secondary in clinical chemistry section

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tumor marker, thyroid function test, hepatitis profile test

services provided by secondary lab given those of secondary in immunology/serology section

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culture sensitivity

services provided by secondary lab given those of secondary in microbiology section

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assisted in production technology, molecular and cellular technology, molecular biology, molecular pathology, forensics pathology, anatomic pathology

special clinical laboratory

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biosafety level 1 laboratory

handles agent that unlikely to cause diseases, personnel required to wear standard PPE such as masks, gloves, laboratory gown

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biosafety level 2 laboratory

handles broad spectrum of moderate risk agent associated with diseases with different degrees of severity

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biosafety level 3 laboratory

handles indigenous or exotic agents with potential to be transmitted via respiratory routes

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biosafety level 4 laboratory

handles extremely dangerous or exotic agent that can be transmitted through air with no available vaccine or therapeutic care

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license to operate

issued by BHFS

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issue official lab result/receipt, perform other test other than monitoring, cater to other patients

physician office laboratory issued license if:

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point-of-care testing

Diagnostic tests done at bedside or near patient care

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pathologist

head of laboratory

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medical technologist

staff

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well lighted, well ventilated, with supply of water

physical facilities

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10m square

primary lab size

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20m square

secondary lab size

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60m square

tertiary lab size

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mobile laboratory

permitted to collect specimen only

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100km radius

operation of mobile laboratory

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october-november

renewal of LTO of non-hospital based laboratory

45
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5 days

processing of LTO should be ___ after expiration

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research institute for tropical medicine

national reference laboratory for microbiology

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san lazaro hospital

national laboratory for HIV/AIDS, hepatitis, syphilis, and other STIs

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east avenue medical center

national reference laboratory for environmental and occupational health, toxicology, and micronutrient assay

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national kidney and transplant institute

national reference laboratory for hematology including immunohematology, immunopathology, and anatomic pathology

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lung center of the philippines

national reference laboratory for biochemistry

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administrative order no. 201 s. 1973

Revised rules & requirements governing the registration, operation, maintenance of clinical laboratories in the Philippines

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october 26, 1973

when was AO no. 201 s 1973 approved

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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

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August 5, 1976

when was AO no. 290 s. 1976 approved

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administrative order no. 59 s. 2001

Rules and Regulations Governing the Establishment, Operation and Maintenance of Clinical Laboratories in the Philippines

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november 19, 2001

when was AO no. 59 s. 2001

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administrative order no. 48 s. 2003

Classification of Clinical Laboratory Based on Institutional Character

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may 23, 2003

when was AO no. 48 s. 2003 approved

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administrative order no. 2007-0027

Revised Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines

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august 22, 2007

when was AO no. 2007-0027 approved

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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”

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august 28, 2008

when was AO no. 2007-0027-a approved