AO-2021-0037 Flashcards
“An Act Regulating the Operation and
Maintenance of Clinical Laboratories and Requiring the Registration of the Same with the
Department of Health, Providing Penalty forthe Violation Thereof,and for Other Purposes,”
Republic Act No. 4688
which is to
guarantee access to quality and affordable health products, devices, facilities and services.
Republic Act No. 11223 or the Universal Health Care Act
refers to any natural juridical person, government
instrumentalities/agencies, partnership, corporation or agency seeking a license to
operate and maintain a clinical laboratory.
Applicant
the checklist which prescribes the minimum standards and
requirements for licensure of a clinical laboratory
Assessment Tool
a formal authorization issued
by the DOH to an individual, partnership, corporation, association or any government
agency/unit seeking to perform laboratory tests in compliance with the requirements
prescribed in this Order.
Department of Health - License to Operate (DOH-LTO) —
a facility that is involved in the (a) pre-analytical, (b)
analytical, (c) and post-analytical procedures, where tests are done on specimens from
the human body to obtain information about the health status of a patient for the
prevention, diagnosis and treatment of diseases.
Clinical Laboratory (CL)
a permit issued by DOH
through HFSRB or Center for Health Development-Regulation, Licensing and
Enforcement Division (CHD-RLED) to an applicant who will establish and operate a
hospital or other health facility, upon compliance with required documents prior to the
actual construction of the said facility.
Department of Health - Permit to Construct (DOH-PTC)
a program where participating CL are
given unknown samples for analysis. These samples should be treated as ordinary
human specimens for the usual processing and examination
External Quality Assessment Program (EQAP)
refer to applications by newly constructed health facilities, or those
with changes in the circumstances of the facility, such as, but not limited to, change of
ownership, transfer of site, increase in beds or for additional services beyond their
service capability and major alterations or renovations. W
Initial Application —
a laboratory testing unit capable of performing
limited CL diagnostic procedures. It moves from one testing site to another,and it has a
DOH-licensed CL asits main laboratory.
Mobile Clinical Laboratory (MCL)
n EQAP activity conducted
by the National Reference Laboratories to assess the quality of performance and
accuracy of the results of laboratories.
national External Quality Assessment Scheme (NEQAS) —
the highest level of laboratory in the country
performing highly complex procedures, including confirmatory testing, that is not
commonly performed by the lower level of laboratory. I
National Reference Laboratory (NRL)
— refers to a doctor’s office/clinic wherein CL
examinations are performed for the purpose of monitoring the doctor’s patients only,
wherein NO official results shall be issued. In this Order, POL within the premises of a
DOH-regulated facility shall be under the supervision of the CL.
Physician’s Office Laboratory (POL)
refers to diagnostic testing done at or near the site of
patient care rather than in the CL. It may be in the emergency room, operating suites,
wards, and ambulances
Point of Care Testing (POCT)
— refers to an extension of the main CL located
within the facility’s compound or premises. It shall have the same service capability as
the main laboratory
Satellite Clinical Laboratory (SCL)
