CLINICAL LABORATORY AND ITS LAWS Flashcards
CLASSIFICATION BASED ON OWNERSHIP
Government-owned
Private owned
CLASSIFICATION BASED ON FUNCTION
CLINICAL PATHOLOGY FUNCTION
CLINICAL ANATOMIC FUNCTION
Clinical chemistry, hematology, immunohematology, microbiology, immunology, clinical microscopy, serology, endocrinology, molecular biology, cytogenetics, toxicology and therapeutic drug monitoring.
CLINICAL PATHOLOGY FUNCTION
surgical, immunology, histopathologic, cytologic autopsy procedure, forensic and molecular pathologic techniques.
CLINICAL ANATOMIC FUNCTION
CLASSIFICATION BASED ON INSTITUTIONAL CHARACTER
Institution-based clinical laboratory
Free standing clinical laboratory
laboratories operates within the premise and as part of an institution, such as hospital, clinic, school or a medical facility.
Institution-based clinical laboratory
Laboratories with no affinity with any other institutions
Free standing clinical laboratory
CLASSIFICATION BASED ON SERVICE CAPACITY
Primary clinical Laboratories
Secondary clinical laboratories
Tertiary clinical laboratories
offer standard laboratory procedure, such as, hematology, urinalysis, fecalysis and blood typing.
Primary clinical Laboratories
provide the minimum service capabilities of a primary laboratory with added services such as routine chemistry analysis, cross matching, gram staining and KOH.
Secondary clinical laboratories
provide the service capabilities of a secondary laboratory with the addition of the following services, special chemistry procedures, special hematology including coagulation procedure, immunology and culture and sensitivity
Tertiary clinical laboratories
Those that handle organisms which are classified by the WHO as risk group 1
Unlikely to cause human disease.
Wear a standard PPE such as gloves, mask and laboratory gown
Special containment systems are not required
BIOSAFETY LEVEL 1 LABORATORIES
Handle a broad spectrum of moderaterisk agents, associated with human disease with different degrees of severity.
Process human derived specimens such as blood, body fluids, tissues and some human cell lines with organism causing the disease is unknown.
Standard PPE, with secondary barriers such as sink, waste decontamination facilities ( ex: autoclave) to reduce transmission of biohazard waste and a biosafety cabinet
BIOSAFETY LEVEL 2 LABORATORIES
Handle Risk group 3 organisms- indigenous or exotic agents with the potential to be transmitted via respiratory routes and can cause severe or fatal infection
All procedure should be done in a biosafety cabinet with a gas-tight aerosol generation chamber.
Access to the laboratory is controlled to prevent potentially infectious aerosols from escaping to the environment
BIOSAFETY LEVEL 3 LABORATORIES
Handles extremely dangerous and exotic agents that can be transmitted through the air, no available vaccine or therapeutic cure.
Personnel are required to wear full body, air supplied positive pressure suits.
Provide a specialized ventilation and waste management system, and operates in a separate building.
BIOSAFETY LEVEL 4 LABORATORIES
Not associated with disease in healthy adult or animals
RG1
Bacillus subtilis, Escherichia coli-K-12, adeno-associated virus type 1-4
RG1
Associated with disease which is rarely serious and for which preventative or therapeutics often available
RG 2
Measle virus, Salmonellaw Toxoplasma spp, Hepa B virus
RG 2
associated with serious or lethal human disease for which preventative or therapeutic may be available
RG3
M. tuberculosis, SARS-associated coronavirus, Hantaan virus
RG 3
associated with lethal human disease for which preventatve or therapeutics are not readily available
RG4
Ebola virus
Marburg virus
RG 4
Clinical laboratory should be headed by a registered medical technologist and managed by a pathologist who is duly certified by Phil. Board of Pathology.
The number of staff in a laboratory depends on the workload and the services provided by the establishment.
Administrative Order No. 2007- 0027 (Clinical Laboratory Staff)
Also known as the “Clinical Laboratory Act of 1966”,
Approved on June 18, 1966
To regulate the operation and maintenance of clinical laboratories, require the registration with Department of Health (DOH), providing penalty for the violation and other purposes.
Republic Act No. 4688 (Clinical Laboratory Act of 1966) -
- Approved by Dr. Clemente Gatmaitan.
Consist of 24 sections
Administrative Order No. 201, S. 1973
Amended subsection (a) of Sec. 11 of AO No. 201, s. 1973 that prescribes the requirements for clinical laboratories.
Pathologist may be authorized to manage and supervise and/or an associate pathologist of NOT MORE THAN THREE (3) CLINICAL LAB and/or BLOOD BANKS CONTINOUSLY LOCATED IN PARTICULAR AREAS.
Localities without qualified pathologist, a qualified physician under Section 7 (b) may head ONLY one clinical laboratory.
Administrative Order No. 290, S. 1976
Section 4,5 and 6 pertain to the purpose, scope and classification of clinical laboratory, which are classified into functions ( clinical pathology, hospital based and non hospital based) and services ( primary, secondary and tertiary)
Section 7, provides the requirements and procedures in applying for clinical laboratory license.
Section 8 discuss the violations of some provisions
Section 9 investigate the complains and some cases related to clinical lab LTO.
Section 10 describe the revocation of license if there is a gross violation of any provision
ADMINISTRATIVE ORDER NO. 59, S. 2001
Includes the classification based on institutional character, hospital and non hospital based laboratories
Differentiates the institution based laboratory and free standing laboratory
ADMINISTRATIVE ORDER NO. 48, S. 2003
Set the revised rules and regulations regarding the establishments, operation and maintenance of clinical laboratories.
Provisions on the rationale, scope and coverage and objectives
Provisions on the classes of clinical laboratories, guidelines, violations, penalties schedules of fees, investigation of complains; penalty, appeal; repealing clause and separability clause
ADMINISTRATIVE ORDER NO. 2007-0027
Amended certain provisions of AO 2007-0027.
Order that exempt the National Tuberculosis Reference Laboratories (NTRL) and Regional TB reference Laboratory performing TB culture from securing a license to operate as clinical laboratory provided they have adhered to the program, policies and international standards and requirements of the National Reference Laboratories.
ADMINISTRATIVE ORDER NO. 2007-0027-A
Implementation of internal and external quality control program as the requirements for licensing clinical laboratories, in which a clinical laboratories are required to have a QUALITY ASSURANCE PROGRAM.
The External Quality Assessment Program (EQAP) requires laboratory to participate in the National External Assessment Program ( NEAP
DEPARTMENT MEMORANDUM ORDER NO. 2009-0086
Requires a clinical laboratory to participate in the National External Assessment Scheme (NEQAS) administered by the designated reference laboratories.
Ordered that starting 2013 and upon filing the application for renewal of the license to operate for 2014, the NEQAS Certificate of Participation Proficiency Training is included as an initial requirement for the issuance of license to operate a clinical laboratory.
DEPARTMENT MEMORANDUM ORDER NO. 2009-0086-A
laboratory for dengue, influenza, tuberculosis and other mycobacteria, malaria and other parasites, bacterial enteric diseases, measles and viral exanthema, mycology, enterovirus, antimicrobial resistance and emerging diseases, and NRL for confirmatory testing of blood units.
RESEARCH INSTITUTE FOR TROPICAL MEDICINE (RITM)
reference laboratory for HIV/AIDS, hepatitis, syphilis and other sexually transmitted infections. (STI’s)
SAN LAZARO HOSPITAL (NRL-SLH/SACCL)
for environmental and occupational health, toxicology and micronutrient assay
EAST AVENUE MEDICAL CENTER
for hematology, immunohematology, immunopathology and anatomic pathology.
NATIONAL KIDNEY AND TRANSPLANT INSTITUTE (NKTI)
for biochemistry
LUNG CENTER OF THE PHILIPPINES
- support the primary objective of health laboratory services of the Secretary of Health.
the designated laboratory by the Secretary of Health are capable of handling and teaching medical technolpgy interns,
prescribes the required sections of training laboratories and the number of specimen per section that should be handled by interns
Administrative Order No. 274, s. 1976
- prescribes rules and regulations regarding the accreditation of clinical laboratories as teaching and training grounds.
the purpose of this administrative order is to upgrade the laboratory services that medical technology interns provide.
DOH through the Bureau of Research and Laboratory (BRL) is empowered to monitor and approve the accreditation of clinical laboratories for medtech interns
Administrative Order No. 118-B, s. 1992
the CHED extends the expiration of accreditation in clinical laboratories.
this extension was given to allow ample time in transferring the accreditation program of teaching and training clinical laboratories from DOH to CHED
CHED memorandum Order No. 6, s. 2008
