LMI notes.pdf - LMI 100: LABORATORY MANAGEMENT TRINITY...

LMI_100: LABORATORY MANAGEMENT [TRINITY UNIVERSITY OF ASIA]
CBSP & NPJM
Lesson 5: Licensing
AO 2021-0031, Annex B1
Assessment Tool for Licensing a General Clinical Lab.
Staffing Pattern for RMT Analysis
1. Clinical Laboratory for Clinical and Anatomic
Pathology
2. Clinical Laboratory for Anatomic Pathology – At
least one RMT per section
3. Clinical Laboratory for Molecular Pathology –
will depend on the service offered
Note: please refer to MTLBIOE lesson/transes for more detailed
reference.
RA 4688: Clinical Laboratory Laws of 1966
Administrative Order 2021-0037
*Download the PDF file in TLC
INTRODUCTION
Clinical Laboratory
- A facility that is involved in the (a) pre-analytical ,
(b) analytical , and (c) 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.
- It does not process/analyze samples from animals
[veterinary laboratory]
- It doesn’t aim for data for research. [research lab]
- Its aim is for human use.
- These tests include, but are not limited to, the
following disciplines:
o Anatomic pathology
o Clinical Chemistry
o Clinical Microscopy
o Endocrinology
o Hematology
o Immunology and Serology
o Microbiology-
o Toxicology
o Molecular and Nuclear Diagnosis
- It is the executive department of the Philippine
government when it comes to the health sector.
1. License to Operate (LTO)
- Formal authorization to perform a laboratory test
- Ensures that a clinical laboratory is compliant
with the requirements of DOH
- Valid for 1 Year
2. Permit to Construct (PTC)
- Given to applicants who wish to
establish/construct or alter/renovate a clinical
laboratory.
- Pre-requite for LTO
3. Certificate of Registration
- Permit for research and teaching laboratories
- Given to institution who want to do research and
train students.
Health Facilities and Services Regulatory Bureau
[HFSRB]
- Agencies of DOH
- Line agency/unit of the Health Regulation Team
of DOH that focuses on the regulation of Health
Facilities and services.
Functions od HFSRB:
1. Set minimum standards for regulation of health
facilities and services.
2. Disseminate regulatory policies and standards for
information and compliance
3. Issue PTC, LTO. Certificate of Accreditation
*Certificate of Accreditation – focus on quality,
continuous improvement quality system… measuring and
apprising the level of quality of different laboratories.
4. Monitoring of health facilities and services to
ensure continuous compliance of health facilities
with regulatory standards.
5. Provide technical assistance, consultation and
advisory services to stakeholders regarding
health regulation
6. Conduct research relative to regulation of health
facilities and services
7. Conduct fact-finding on complaints against
health facilities and services
8. Act on complaint against hospitals and other
health facilities
Clinical Laboratory
Department of Health (DOH)
ACCREDITING ORGANIZATIONS