nature of clinical laboratory Flashcards
Most critical section
Blood Bank/Immunohematology
platelets
thrombocytes
white blood cells
leukocytes
red blood cells
erythrocytes
blood testing for determination of various coagulation factors
coagulation studies
enumeration of cells in the blood & other body fluids (eg: CSF, pleural, etc.)
Hematology
Identifies bacteria & fungi on specimen
Microbiology
Testing of blood & other body fluids to
quantify essential soluble chemicals including waste products for the diagnosis of certain diseases
clinical chemistry
governing affiliation of MT schools, colleges & universities in government hospitals under the DOH
AO 247, s. 1976
for the accreditation of training labs for MT interns
AO 21, s. 1979
for the accreditation of clinical labs for training of MT interns
AO 118-B, s. 1992
revised fees for lab diagnostic procedures performed in the BRL
AO 14-A, s. 1997
the national policy
on cyto-screening in cervical cancer
control program designation of MTs as
cyto-screeners
AO 19-A, s. 1998
the national policy
on cyto-screening in cervical cancer
control program designation of MTs as
cyto-screeners
AO 19-A, s. 1998
decentralization of some regulatory functions of the Bureau of Health Facilities and Services on Clinical Laboratories & HIV testing labs to the centers for health development in the transition phase
AO 7-C, s. 2001
NS1-Ag for dengue
Immunology & serology
the national policy
on cyto-screening in cervical cancer
control program designation of MTs as
cyto-screeners
AO 19-A, s. 1998
decentralization of some regulatory functions of the Bureau of Health Facilities and Services on Clinical Laboratories & HIV testing labs to the centers for health development in the transition phase
AO 7-C, s. 2001
NS1-Ag for dengue
Immunology & serology
rapid plasma reagin
Immunology & serology
treponema pallidum
particle agglutination
tests
Immunology & serology
differential staining
techniques
Microbiology, bacteriology, &
mycology
culture & identification of
bacteria & fungi from
specimens
Microbiology, bacteriology, &
mycology
antimicrobial
susceptibility testing
Microbiology, bacteriology, &
mycology
clinical enzymology
Special clinical chemistry
markers for certain
diseases
Special clinical chemistry
therapeutic drug
monitoring
Special clinical chemistry
bone marrow studies
Special hematology
special staining for
abnormal cells
Special hematology
red cell orphology
Special hematology
blood donation program
Immunohematology & blood
banking
antibody screening &
identification
Immunohematology & blood
banking
preparation of blood
components
Immunohematology & blood
banking
lab in a government hospital
designated by the DOH to provide
special diagnostic functions &
services for certain diseases
National Reference Laboratory
perform all lab tests in secondary category plus:
Tertiary Category
perform lab tests done by the primary category with routine clinical chemistry tests
Secondary category
perform basic routine lab testing
Primary category
owned, established &
operated by an individual,
corporation, institution, association,
or organization
Privately
owned,
wholly/partially, by national/local
government units (usually by DOH)
Government
operates within the premises or part
of an institution
Institution based/Hospital-based
microscopic examination of tissues &
organs
Anatomical Pathology
testing of
blood & other bodily fluids
Clinical Pathology
“Rules and Regulation Governing the Establishment, Operation, and Maintenance of Clinical Laboratories in the Philippines”
Section 1: Title
CLINICAL LABORATORY LAWS
RA 4688
JUNE 18, 1966
• Implements RA 4688 • DOH, through the Bureau of Health Facilities and Services (BHFS) shall exercise the regulatory functions under these rules & regulations
Section 2: Authority
To protect & promote health of the people by ensuring availability of clinical labs that are properly managed with adequate resources, with effective & efficient performance through compliance with quality standards
Section 3: Purpose
- Apply to all entities performing the activities & functions of clinical labs (analysis & examination of all samples of human tissues & body fluids)
- except for government labs doing lab examinations limited to acid fast bacilli microscopy, malaria screening & cervical cancer screening
Section 4: Scope
• Permit to construct is given by BHFS prior to submission of Petition to Operate • license to operate is issued by BHFS/CHD
Section 6: Policies
• Inspection shall be done by director of BHFS/CHD every two years or as necessary
Section 7: Requirements &
Procedures for Application of Permit
to Construct & License to Operate
• Operation of a clinical lab without a certified pathologist or registered MT • change of ownership, location, head of laboratory or personnel without informing the BHFS/CHD • refusal to allow inspection of the clinical lab by the person/s authorized by the BHFS during reasonable hours • gross negligence • any act/omission detrimental to the public
Section 8: Violations
• Done by BHFS/CHD • violation of RA 4688 will mean suspension, cancelation or revocation of the license as well as the authority of the offending person/s • operation without proper license shall be subjected to imprisonment for 1 month - 1 year, or fine of P1000.00 - P5000.00, or both
Section 9: Investigation of
Charges/Complaints
• A license may be revoked, suspended or modified in full or in part for any material false statement by the applicant, or as shown by the record of inspection or for a violation of, or failure to comply any of the terms and conditions & provisions of these rules & regulations.
Section 10: Modification &
Revocation of License
Rules & regulations shall
supersede all other previous
official issuance hereof.
Section 11: Repealing Clause
A list of licensed clinical labs
must be published annually in a
newspaper or general
circulation.
Section 12: Publication of List of
Licensed Clinical Labs
Rules & regulations shall take
effect 15 days after its
publication in a newspaper or
general circulation.
Section 13: Effectivity
