Week 4: The Clinical Laboratory And Its Law Flashcards
Also known as Clinical Laboratory Act of 1966
REPUBLIC ACT NO. 4688
When was RA no.4688 created?
June 18, 1966
AN ACT REGULATING THE OPERATION AND
MAINTENANCE OF CLINICAL LABORATORIES AND REQUIRING THE REGUSTRATION OF THE SAME WITH THE DEPARTMENTS OF HEALTH, PROVIDING PENALTY AND VIOLATION THEREOF, AND FOR OTHER PURPOSES
REPUBLIC ACT NO. 4688/CLINICAL LABORATORY
ACT OF 1966
A type of classification of clinical laboratories based on the roles or image projected by the clients.
CLASSIFICATION BASED ON SERVICE CAPACITY
Working are for medical technologist
CLINICAL LABORATORY
Clinical laboratory practitioner
CLINICAL LABORATORY STAFF
One of the inherent qualities of a registered medical technologist who is working in a clinical laboratory
COMPENTENCY
An act regulating the operation and maintenance of clinical laboratories and requiring registration of the same with the Department of Health
REPUBLIC ACT NO. 4688
UNDER WHAT ADMINISTRATIVE ORDER NO. OF THE REVISED RULES AND REGULATIONS GOVERNING THE LICENSING AND REGULATION OF LABORATORIES IN THE PHILIPPINES, CAN CLINICAL LABORATORIES BE CLASSIFIED BASED ON?
ADMINISTRATIVE ORDER NO. 2007-0027
Give the 4 classification of clinical laboratories
- BASED ON OWNERSHIP
- BASED ON FUNCTION
- BASED ON INSTITUTIONAL CHARACTER
- BASED ON SERVICE CAPACITY
- Clinical laboratories may be considered GOVERNMENT-OWNED or PRIVATE.
- Government owned laboratories are those which are maintained, partially or wholly, by either the national or local government.
- Private laboratories are established, operated, and maintained by individual, corporation, or association without any affinity with the government.
BASED ON OWNERSHIP
2 types of Laboratory Based on Function
CLINICAL PATHOLOGY FUNCTION and ANATOMIC PATHOLOGY FUNCTION
clinical chemistry, hematology, immunohematology, microbiology, immunology, clinical microscopy, serology, endocrinology, molecular biology, cytogenetic, toxicology, and therapeutic drug monitoring.
CLINICAL PATHOLOGY FUNCTION
surgical, immunology, histopathologic cytologic, autopsy procedure, forensic, and molecular pathologic techniques
ANATOMIC PATHOLOGY FUNCTION
Institute based clinical laboratory and Free-standing laboratory
BASED ON INSTITUTIONAL CHARACTER
This clinical laboratory operates within the premises and as part of institution such as hospital, clinic, school, or medical facility. E.g. Department of Pathology of the National Kidney and Transplant Institute.
Institute based clinical laboratory
Has no affinity with any other institution. For instances, the Hi-Precision Diagnostic laboratory is considered free-standing
Free-standing laboratory
Primary, Secondary, Tertiary and Limited-service capability
BASED ON SERVICE CAPABILITY
– provides the following minimum service capabilities:
I. Routine Hematology: CBC
II. Qualitative Platelet Determination
III. Routine Urinalysis, Fecalysis
IV. Blood typing – Hospital-based
Primary Category
- provides the following minimum service
capabilities of primary lab + the ff:
I. Routine Clinical Chemistry
II. Quantitative Platelet Determination
III. Cross matching, Gram Staining, KOH - Hospital-based
Secondary Category
provides the following minimum service capabilities of secondary lab + the ff:
I. Special chemistry
II. Special hematology, including coagulation procedures
III. Immunology
IV. Microbiology – culture and sensitivity
● Aerobic and Anaerobic – hospital-based
● Aerobic or Anaerobic – non-hospital-based
Tertiary Category
provides lab test required for a particular service in institutions such as but not limited to, dialysis center & hygiene clinics
Limited-service capability (institution-based)
A laboratory that offers highly specialized laboratory services that are usually not provided by a general clinical laboratory.
BASED ON SERVICE CAPABILITY (SPECIALIZED CLINICAL LABORATORY)
- Handle organisms that are unlikely to cause human diseases.
- Personnel are expected to wear the standard PPE such as mask, gloves, and laboratory gown.
Biosafety level 1
Bacillus subtilis, Escherichia coli, Adeno-associated virus, Baculovirus, Saccharomyces cerevisae
RG-1 organisms
- Handle a broad spectrum of moderate risk agents or organisms, associated with human diseases with different degrees of severity
- Personnel who works at this type of laboratory normally process human derived specim en such as blood, body fluids, tissues and to extend human cells. Aside from wearing PPE, the personnel have a second barriers such as sink, waste decontamination facilities (autoclave) and biosafety cabinet
Biosafety level 2
- Handle organisms that are considered indigenous or exotic agents with potential to be transmitted via respiratory routes.
- All procedures in processing should be done in a biosafety cabinet with a gas tight aerosol generation chamber.
Biosafety level 3
Staphylococcus aureus, Herpes simplex virus, Salmonella spp, Measles, Enterovirus,
RG-2 organisms
Mycobacterium tuberculosis, HIV, HBV, MERS, Vibrio
cholera
RG-3 organisms
Ebola virus, Marbug virus, Lassa virus, Hendra virus, Nipah virus, Flavivirus, Influenza, Yellow fever, Smallpox, Hemorrhagic fever
RG-4 organisms
- Handle extremely dangerous and exotic agents that can be transmitted through air, have no available vaccine or therapeutic cure
- Personnel who works under this laboratory is required to wear a full-body, air supplied positive pressure suits.
Biosafety level 4
- A clinical laboratory should be headed by a registered medical technologist and managed by a pathologist (clinical or anatomical pathologist) who is duly certified by the Philippine Board of Pathology.
- The number of medical technologist staff in a laboratory depends on the workload and the services provided by the establishment.
A.O NO. 2007-0027 (CLINICAL LABORATORY STAFF)
- Approved on June 18, 1966
- The act was put into effect to regulate the operation and maintenance of clinical laboratories and to require their registration with the Department of Health.
R.A NO. 4688 CLINICAL LABORATORY ACT OF 1966
Amended subsection (a) of section 11 of A.O No. 201 s. 1973 that describes the requirements for clinical laboratories E.g. pathologist may be authorized to manage and supervise and/or an associate pathologist of not more than three clinical laboratories and/or blood banks continuously located in particular area.
A.O NO. 290 s. 1976
Describes the rules and regulations regarding implementation of internal and external quality control programs as the requirements for licensing of the clinical laboratories in which a clinical laboratory required to have a quality assurance program.
DEPARTMENT MEMORANDUM ORDER NO. 2009-0086
covers the inputs, processes, and outputs
including the continuous quality improvement program.
Internal quality control
requires a clinical laboratory to participate in the National External Assessment Program (NEAP)
External quality assessment program
NEAP
National External Assessment Program
EQAP
External Quality Assessment Program
This memorandum order contains all the designated reference laboratories for EQAP
DEPARTMENT MEMORANDUM ORDER NO. 2009-0086
national reference laboratory for dengue, influenza, tuberculosis, and other mycobacteria, malaria, and other parasites, bacterial enteric disease, measles,
emerging diseases, and NRL for confirmatory testing of blood units.
RITM
national reference laboratory for HIV/AIDS, hepatitis,
syphilis, and other sexually transmitted infections
SAN LAZARO HOSPITAL
NRL for environmental and occupational
health; toxicology, and micronutrient assay
EAST AVENUE MEDICAL CENTER
NRL for hematology including immunohematology, immunopathology and anatomic pathology
NATIONAL KIDNEY AND TRANSPLANT INSTITUTE
NRL for biochemistry
LUNG CENTER OF THE PHILIPPINES
