5 - LICENSING Flashcards
(34 cards)
1
Q
- 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
A
Clinical Laboratory
2
Q
tests included in the clinical laboratory
A
- Anatomic Pathology
- Clinical Chemistry
- Clinical Microscopy
- Endocrinology
- Hematology
- Immunology & Serology
- Microbiology
- Toxicology
- Molecular and Nuclear Diagnostics
3
Q
Provider of:
1. License to Operate (LTO)
2. Permit to Construct (PTC)
3. Certificate of Registration
A
Department of Health
4
Q
- Formal authorization to perform laboratory tests
- Ensure that the clinical laboratory is compliant with the requirements of DOH
- Valid for 1 year
A
License to Operate (LTO)
5
Q
Given to applicants who wish to establish / construct or alter / renovate a clinical laboratory
A
Permit to Construct (PTC)
6
Q
Permit for research and teaching laboratories
A
Certificate of Registration
7
Q
Accrediting Organizations
A
- Health Facilities and Services Regulatory Bureau
- Center for Health Development
- National Reference Laboratory
8
Q
A DOH-licensed laboratory should:
A
- 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
9
Q
Line agency / unit of the Health Regulation Team of DOH that focuses on the regulation of health facilities and services
A
Health Facilities and Services Regulatory Bureau
10
Q
- 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
A
Functions of Health Facilities and Services Regulatory Bureau
11
Q
- Line agency / unit of DOH under the Field Implementation & Coordination Team
- One for each region
A
Center for Health Development
12
Q
- 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
A
Functions of Center for Health Development
13
Q
- Highest level of laboratory in the country
- Responsible for facilitating NEQAS to ensure compliance of all laboratories to the standards set in the Philippines
A
National Reference Laboratory
14
Q
- 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
A
Functions of National Reference Laboratory
15
Q
Requirements for Licensing Reference
A
AO 2021-0037 Annex A
16
Q
Requirements for Licensing Sections
A
- Physical Plant
- Personnel
- Equipment / Instruments / Reagents / Glassware / Supplies
- Service Delivery
- Information Management
- Quality Improvement
- Referral of Laboratory Examinations
- Environmental Management
17
Q
- Compliance to the local and national regulations for constructing / maintaining / repairing a clinical laboratory
- Compliance with the required space and minimum area requirements
A
Physical Plant
18
Q
- 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)
A
Personnel
19
Q
- 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
A
Equipment / Instruments / Reagents / Glassware / Supplies
20
Q
- 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
A
Service Delivery
21
Q
- Administrative Policies and Procedures
- Communication and Records Management
1. Includes maintaining the confidentiality of all records
A
Information Management
22
Q
- Use of a system for continuous quality improvement activities
- Required participation in Internal Quality Assurance Program and External Quality Assurance Program
A
Quality Improvement
23
Q
- 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
A
Referral of Laboratory Examinations
24
Q
- 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
A
Environmental Management
25
Violations and Penalties
Section IX of AO 37-2021
26
any act against the general, specific and procedural guidelines provided by the AO and other related issuances and laws
Violation
27
# Non-Institution-Based Clinical Laboratory
1st offense
Stern warning
28
# Non-Institution-Based Clinical Laboratory
2nd offense
30,000 pesos
29
# Non-Institution-Based Clinical Laboratory
3rd offense
50,000 pesos
30
# Non-Institution-Based Clinical Laboratory
4th offense
Revocation of DOH-LTO
31
Penalty for Institution-Based Clinical Laboratory
Will follow penalties for hospitals
32
# RA 4688 (Section 4)
Imprisonment
One month to one year
| may be either or both
33
# RA 4688 (Section 4)
Fine
1,000 to 5,000 pesos
| may be either or both
34
Operating a CL with no PTC and LTO
* Cease-and-desist order
* Fine: 50,000 pesos
