Chapter 5: Licensing

Clinical Laboratory

A facility that is involved in the pre-analytical, analytical, 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

License to Operate

Formal authorization to perform laboratory tests

License to Operate

Ensures that the clinical laboratory is compliant with the requirements of DOH

one (1) year

validity of LTO

Permit to Construct

Given to applicants who wish to establish/construct or alter/renovate a clinical laboratory

Permit to Construct

a Pre-requisite for LTO

Certificate of Registration

Permit for research and teaching laboratories

Annex B1

What annex of AO2021-0037 does the assessment tool for licensing a general clinical laboratory belong to?

Health Facilities and Services Regulatory Bureau

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

they set minimum standards for regulation of health facilities and services

Health Facilities and Services Regulatory Bureau

they disseminate regulatory policies and standards for information and compliance

Health Facilities and Services Regulatory Bureau

they issue permits to construct, License to Operate and Certificate of Accreditation

Health Facilities and Services Regulatory Bureau

they monitor of health facilities and services to ensure continuous compliance of health facilities with regulatory standards

Health Facilities and Services Regulatory Bureau

they provide technical assistance, consultation and advisory services to stakeholders regarding health facilities regulation

Health Facilities and Services Regulatory Bureau

they conduct research relative to regulation of health facilities and services

Health Facilities and Services Regulatory Bureau

they conduct fact-finding on complaints against health facilities and services

Health Facilities and Services Regulatory Bureau

they act on complaints against hospitals and other health facilities

Center for Health Development

Line agency/unit of DOH under Field Implementation & Coordination Team

Center for Health Development

they strictly enforce the provisions of AO 2021-0037

Center for Health Development

they 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

Center for Health Development

they provide consultation and technical assistance to stakeholders in line with the regulation of CL

Center for Health Development

they respond promptly to complaints relative to the operation of CL under the jurisdiction

National Reference Laboratory

Highest level of laboratory in the country

National Reference Laboratory

they a responsible for facilitating **NEQAS** to ensure compliance of all laboratories to the standards set in the Philippines

National Reference Laboratory

they provide laboratory reference/referral services for confirmatory testing

National Reference Laboratory

they train laboratory personnel and recognize other training institutions

National Reference Laboratory

they maintain the National External Quality Assessment Scheme (NEQAS)

National Reference Laboratory

they perform technical evaluation of reagents and diagnostic kits

8 sections

How many sections should a Clinical lab have for licensing?

Pathologist

who is the head of the Laboratory

* Laboratory technician
* Laboratory aide
* Encoder
* Receptionist

Who are the support staffs?

Equipment Instruments Reagents Glassware Supplies

this falls under what section?

* Availability of operational equipment

Equipment Instruments Reagents Glassware Supplies

this falls under what section?

* Performance of calibration, preventive maintenance, and repair programs

Equipment Instruments Reagents Glassware Supplies

this falls under what section?

* contingency plans in case of equipment breakdown and malfunction

Equipment Instruments Reagents Glassware Supplies

this falls under what section?

* Use of FDA-approved and NRL- validated devices, reagents, and test kits

Physical Plant

this falls under what section?

* Compliance with the local and national regulations for constructing/maintaining/ repairing a clinical laboratory

Physical Plant

this falls under what section?

* Compliance with the required space and minimum area requirement

Service Delivery

this falls under what section?

* Compliance with the allowed services for each classification

Information Management

this falls under what section?

* Administrative Policies and Procedures

Information Management

this falls under what section?

* Communication and Records Management

Quality Improvement

this falls under what section?

* Use of a system for continuous quality improvement activities

Quality Improvement

this falls under what section?

* Required participation in Internal Quality Assurance Program and External Quality Assessment Program

Memorandum of Agreement

Partnerships with a referral laboratory should be made through a ___________________

100 km or 100,000 m

Operation of mobile clinical laboratory (MCL) shall only be ____________ from the address of the
main laboratory

Section 9 / IX

Under what section of AO 2021-0037 does the Violations and Penalties belong to?

Stern warning

For a non-institution based CL, what is the penalty for their 1st offense?

30,000 pesos

For a non-institution-based CL, what is the penalty for their 2nd offense?

50,000 pesos

For a non-institution based CL, what is the penalty for their 3rd offense?

Revocation of DOH-LTO

For a non-institution based CL, what is the penalty for their 4th offense?

* 1 month to 1 year imprisonment
* 1,000 to 5,000 pesos fine

For institution based CL, what is/are the penalties for those who have violated AO 2021-0037?

* Cease-and-desist order
* 50,000 pesos fine

Operating a CL with no PTC and LTO will have a penalty of?

SACNTIONED

Tell whether the action will be sanctioned or the DOH-LTO will be revoked:

* Refusal to allow HFSRB/CHD-RLED authorized personnel to conduct inspection or monitoring visits

SACNTIONED

Tell whether the action will be sanctioned or the DOH-LTO will be revoked:

* Refusal or nonparticipation of any CL in an External Quality Assessment Program (EQAP)

SACNTIONED

Tell whether the action will be sanctioned or the DOH-LTO will be revoked:

* Absence of action to improve the unsatisfactory or failed EQAP administered by a designated NRL

SACNTIONED

Tell whether the action will be sanctioned or the DOH-LTO will be revoked:

* Deviation from the standard test procedures including use of expired reagents

SACNTIONED

Tell whether the action will be sanctioned or the DOH-LTO will be revoked:

* Issuance of a laboratory report without the approval of the head of the laboratory

SACNTIONED

Tell whether the action will be sanctioned or the DOH-LTO will be revoked:

* Transferring laboratory results done by another laboratory to the resulting form of the referring laboratory

SACNTIONED

Tell whether the action will be sanctioned or the DOH-LTO will be revoked:

* Performing laboratory procedures beyond their
authorized service capability

SACNTIONED

Tell whether the action will be sanctioned or the DOH-LTO will be revoked:

* Giving and receiving any commission, bonus, kickback or rebate or engaging in any split-fee arrangement

SACNTIONED

Tell whether the action will be sanctioned or the DOH-LTO will be revoked:

* Violation of provisions in the Republic Act No. 10173 or the Data Privacy Act of 2021

REVOCATION OF DOH-LTO

Tell whether the action will be sanctioned or the DOH-LTO will be revoked:

* Permitting unauthorized or unregistered personnel to perform technical procedures and access to laboratory records/data

REVOCATION OF DOH-LTO

Tell whether the action will be sanctioned or the DOH-LTO will be revoked:

* Lending or using the name of the DOH-licensed CL or the head of the laboratory or medical technologist to an unlicensed CL

REVOCATION OF DOH-LTO

Tell whether the action will be sanctioned or the DOH-LTO will be revoked:

* Unauthorized use of the name and signature of the pathologist and RMT to secure LTO

REVOCATION OF DOH-LTO

Tell whether the action will be sanctioned or the DOH-LTO will be revoked:

* Issuance of fraudulent laboratory results, or tests not actually done or inaccurate results

REVOCATION OF DOH-LTO

Tell whether the action will be sanctioned or the DOH-LTO will be revoked:

* Change in the ownership, location, and head of the laboratory or laboratory personnel without informing the HFSRB/CHD-RLED

REVOCATION OF DOH-LTO

Tell whether the action will be sanctioned or the DOH-LTO will be revoked:

* Any material false statement in the application of LTO