wk6 clinical lab law Flashcards
primary purpose of a clinical laboratory is
to be able to
determine the character and quantity of the various chemical
substances in the blood and other body fluids, tissue, secretions,
and excretions.
R.A 4688 was approved and promulgated for its purpose on
preventing the operation and maintenance of substandard,
improperly managed and poorly equipped clinical laboratories
june 18, 1966
The implementing guidelines of R.A 4688 are contained in
administrative order No. 59 S. 2001
These rules and regulations are issued to implement R.A 4688: Clinical
Laboratory Law consistent with
E.O. 102 s. 1999:
shall exercise the regulatory functions under
these rules and regulations.
The Department of Health
(DOH), through the Bureau of Health Facilities and Services (BHFS) in the
Health Regulation Cluster,
classification of lab by function
clinical and anatomic
classification of lab by institution character
hospital-based lab and non-hospital-based lab
classification of lab by service capability
primary secondary and teritary
An approved permit to construct and design lay-out of a clinical
laboratory shall be secured from the prior to submission of an
application for a Petition to Operate
BHFS
A clinical laboratory shall operate with a valid license issued by
?????? based on compliance with the minimum licensing requirements
BHFS/CHD,
(BHFS)
the Bureau of Health Facilities and Services
CHD
Center for Health Development
No clinical laboratory shall be constructed unless plans have been
approved and construction permit issued by the
BHFS
Application for Permit to Construct. the following are the
documents required:
7.1.1 Letter of Application to the Director of Bureau of Health Facilities
and Services (BHFS)
7.1.2 Four sets of Site Development Plans and Floor Plans approved by
an architect and/or engineer
7.1.3 DTI/SEC Registration (for PRIVATE clinical laboratory)
APPLICATION OF NEW LICENSE
A duly notarized application from “Petition to Establish,
Operate, and Maintain a Clinical Laboratory”
, shall be filed
by the owner or his duly authorized representative at the BHFS
RENEWAL OF LICENSE
A duly notarized application from “Petition to Establish,
Operate, and Maintain a Clinical Laboratory”
, shall be filed
by
the owner or his duly authorized representative at the Center
for Health Development (CHD)
Application for renewal of a license shall be filed within
90 days
before the expiry date of the license
All fees shall be paid to the cashier of the
BHFS/CHD
A penalty of ??? for late
renewal shall be charged in
addition to the renewal fee
for all categories if the
application is filed during
the ?????
A penalty of one thousand
pesos (P1, 000.00) for late
renewal shall be charged in
addition to the renewal fee
for all categories if the
application is filed during
the next two (2) months
after expiry date.
An application received
???? shall be
fined ??? for each month
Thereafter in addition to the
An application received
more than two (2) months
after expiry date shall be
fined one hundred pesos
(P100.00) for each month
thereafter in addition to the
1, 000.00 penalty.
Each license shall make available to the ???? or his duly authorized representative(s) at any reasonable
time, the premises and facilities where the laboratory examinations are
being performed for inspection.
Director of the BHFS/CHD
Clinical laboratories shall be inspected
every two (2) years or as
necessary.
All clinical laboratories shall make available to the ??? his duly authorized representative(s) records for
monitoring.
Director of
the BHFS or
The license shall be issued by the ???????? or their
authorized representative, if the application is found to be
meritorious.
Director of the CHD
The owner or authorized representative of any clinical laboratory desiring to transfer
a licensed clinical laboratory to another location shall inform the CHD in writing at least ??? before actual transfer.
The owner or authorized representative of any clinical laboratory desiring to transfer
a licensed clinical laboratory to another location shall inform the CHD in writing at least 15
days before actual transfer.
Any change affecting the substantial conditions of the license to operate a laboratory
shall be reported within??? in writing by the person(s) concerned, to the ??? for
notation and approval Failure to do so will cause the revocation of the license of the
clinical laboratory.
Any change affecting the substantial conditions of the license to operate a laboratory
shall be reported within 15 days in writing by the person(s) concerned, to the BHFS/CHD for
notation and approval Failure to do so will cause the revocation of the license of the
clinical laboratory.
The License to operate a clinical laboratory shall be
suspended or revoked by the ???? upon violation
of ???
thereto.
The License to operate a clinical laboratory shall be
suspended or revoked by the Secretary of Health upon violation
of R.A. 4688 or the Rules and Regulations issued in pursuance
thereto.
T???? are authorized to report to the CHD and BHFS the existence of unlicensed clinical laboratories or any private party performing laboratory examinations without proper license and/or violations
to these rules & regulations.
The Provincial, City and Municipal Health Officers are
authorized to report to the CHD and BHFS the existence of
unlicensed clinical laboratories or any private party performing
laboratory examinations without proper license and/or violations
to these rules & regulations.
Any person who operates a clinical laboratory without the proper license from the Department of
Health shall upon conviction be subject to imprisonment for ????? or a fine of not less than ??????? or both at the discretion of
the court. Provided, however, that if the offender is a firm or a corporation, the Managing Head and/or
owner/s thereof shall be liable to the penalty imprisoned herein.
Any person who operates a clinical laboratory without the proper license from the Department of
Health shall upon conviction be subject to imprisonment for not less than 1 month but not more than 1
year or a fine of not less than P1, 000.00 and not more than P5, 000.00 or both at the discretion of
the court. Provided, however, that if the offender is a firm a corporation, the Managing Head and/or
owner/s thereof shall be liable to the penalty imprisoned herein.
The Clinical Laboratory shall be managed by a ???
The Clinical Laboratory shall be managed by a licensed
physician certified by the Philippine Board of Pathology.
In areas where pathologists are not available, a physician with ?????, may
manage a ???
The ???shall certify such training
In areas where pathologists are not available, a physician
with three (3) months of training in clinical laboratory
medicine, quality control, and laboratory management, may
manage a primary/secondary category clinical laboratory.
The BHFS shall certify such training
The working space for all categories of clinical
laboratories (both hospital and non-hospital-based)
shall have at least the following measurements:
primary 10
secondary = 20
teritary = 60
2 quality control programs
- quality assurance program
- external quality control program
All clinical laboratories shall participate in an External Quality
Assurance Program given by designated
national Reference Laboratories
and/or other recognized reference laboratorie
All laboratory reports on various examinations of specimens shall bear the name
of the
egistered medical technologist and the pathologist and be duly
signed by both
.All laboratory records shall be kept on file for at least ???
There shall be a system of accurate recording to ensure quality
results.
1 year
3.1 Records of anatomic and forensic pathology shall be kept
???in the laboratory
3.1 Records of anatomic and forensic pathology shall be kept
permanently in the laboratory
Professional services rendered to the patient in the performance
of special procedures or examinations shall be charged
separately
and not included in the laboratory fee
