5 - LICENSING Flashcards
- Facility that is involved in pre-analytical, analytical, & 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, & treatment of diseases
Clinical Laboratory
tests included in the clinical laboratory
- Anatomic Pathology
- Clinical Chemistry
- Clinical Microscopy
- Endocrinology
- Hematology
- Immunology & Serology
- Microbiology
- Toxicology
- Molecular and Nuclear Diagnostics
Provider of:
1. License to Operate (LTO)
2. Permit to Construct (PTC)
3. Certificate of Registration
Department of Health
- Formal authorization to perform laboratory tests
- Ensure that the clinical laboratory is compliant with the requirements of DOH
- Valid for 1 year
License to Operate (LTO)
Given to applicants who wish to establish / construct or alter / renovate a clinical laboratory
Permit to Construct (PTC)
Permit for research and teaching laboratories
Certificate of Registration
Accrediting Organizations
- Health Facilities and Services Regulatory Bureau
- Center for Health Development
- National Reference Laboratory
A DOH-licensed laboratory should:
- Continuously comply with its rules and regulations, licensing standards and requirements
- Participate in EQAP that may be administered by a designated NRL or other local and international EQAP approved by the DOH surveys and other activities that will be required from them by the DOH
- In times of Pandemic and Public Health Event, be mandated to submit timely reports and data
Line agency / unit of the Health Regulation Team of DOH that focuses on the regulation of health facilities and services
Health Facilities and Services Regulatory Bureau
- Set minimum standards for regulation of health facilities and services
- Disseminate regulatory policies and standards for information and compliance
- Issue permits to construct, License to Operate, and Certificate of Accreditation
- Monitoring of health facilities and services to ensure continuous compliance of health facilities with regulatory standards
- Provide technical assistance, consultation, and advisory services to stakeholders regarding health facilities regulation
- Conduct research to regulation of health facilities and services
- Act on complaints against hospitals and other health facilities
Functions of Health Facilities and Services Regulatory Bureau
- Line agency / unit of DOH under the Field Implementation & Coordination Team
- One for each region
Center for Health Development
- Strictly enforce the provisions of AO 2021-0037
- Submit quarterly report on Suspension / Revocation / Cease and Desist Order issued on CL not later than the 15th day of the following month after the covered quarter
- Provide consultation and technical assistance to stakeholders in line with the regulation of CL
- Respond promptly to complaints relative to the operation of CL under its jurisdiction
Functions of Center for Health Development
- Highest level of laboratory in the country
- Responsible for facilitating NEQAS to ensure compliance of all laboratories to the standards set in the Philippines
National Reference Laboratory
- Provide laboratory reference / referral services for confirmatory testing
- Train laboratory personnel and recognize other training institutions
- Maintain the National External Quality Assessment Scheme (NEQAS)
- Perform technical evaluation of reagents and diagnostic kits
Functions of National Reference Laboratory
Requirements for Licensing Reference
AO 2021-0037 Annex A
Requirements for Licensing Sections
- Physical Plant
- Personnel
- Equipment / Instruments / Reagents / Glassware / Supplies
- Service Delivery
- Information Management
- Quality Improvement
- Referral of Laboratory Examinations
- Environmental Management
- Compliance to the local and national regulations for constructing / maintaining / repairing a clinical laboratory
- Compliance with the required space and minimum area requirements
Physical Plant
- Head of Pathology – Pathologist
- Registered Medical Technologist
- Support Staff
1. Laboratory technician
2. Laboratory aide
3. Encoder
4. Receptionist - POCT coordinator and operator (if applicable)
Personnel
- Availability of operational equipment
- Performance of calibration, preventive maintenance, and repair programs
- Contingency plans in case of equipment breakdown and malfunction
- Inventory and proper storage of reagents, glassware, and supplies
- Use of FDA-approved and NRL-validated devices, reagents, and test kits
Equipment / Instruments / Reagents / Glassware / Supplies
- Compliance with the allowed services for each classification
- Operation of mobile clinical laboratories (MCL) shall only be 100km from the address of the main laboratory
Service Delivery
- Administrative Policies and Procedures
- Communication and Records Management
1. Includes maintaining the confidentiality of all records
Information Management
- Use of a system for continuous quality improvement activities
- Required participation in Internal Quality Assurance Program and External Quality Assurance Program
Quality Improvement
- Partnership with a referral laboratory through a Memorandum of Agreement
- Referral of tests may be made if:
1. The test is not part of the service capability of the laboratory
2. There is an equipment breakdown or other similar instances
Referral of Laboratory Examinations
- Proper maintenance and monitoring of physical facilities
- Proper disposal procedure for infections / toxic / hazardous waste
- No smoking policy
- Contingency plans for accidents and emergencies
- Policy for biosafety and biosecurity
- Policy guidelines on infection prevention and control
Environmental Management
Violations and Penalties
Section IX of AO 37-2021
any act against the general, specific and procedural guidelines provided by the AO and other related issuances and laws
Violation
Non-Institution-Based Clinical Laboratory
1st offense
Stern warning
Non-Institution-Based Clinical Laboratory
2nd offense
30,000 pesos
Non-Institution-Based Clinical Laboratory
3rd offense
50,000 pesos
Non-Institution-Based Clinical Laboratory
4th offense
Revocation of DOH-LTO
Penalty for Institution-Based Clinical Laboratory
Will follow penalties for hospitals
RA 4688 (Section 4)
Imprisonment
One month to one year
may be either or both
RA 4688 (Section 4)
Fine
1,000 to 5,000 pesos
may be either or both
Operating a CL with no PTC and LTO
- Cease-and-desist order
- Fine: 50,000 pesos
