RA 4688 Flashcards
What is the role of clinical laboratories in healthcare?
They help detect, diagnose, treat, and monitor diseases.
Why was R.A. 4688 created?
To prevent substandard, poorly managed, and unequipped laboratories from operating.
*approved on June 18, 1966
* ensure that clinical laboratories meet proper standards and provide quality healthcare services.
objective of the clinical laboratory law
- To prescribe minimum standard for clinical laboratories;
- To ensure accuracy and precision of laboratory examinations in order to safeguard public health and safety; and
- To ensure access to quality and affordable health products, devices, facilities and services, especially those commonly used by the poor.
RA 4688 Title
“Rules and Regulations Governing the Establishment Operation and Maintenance of Clinical Laboratories in the Philippines”
What law governs clinical laboratories?
R.A. 4688 (Clinical Laboratory Law)
total of 13 sections
Which executive order helps organize the DOH’s functions?
E.O. 102 (1999)
- reorganized the Department of Health (DOH). The DOH, through a special group called BHFS (Bureau of Health Facilities and Services), is in charge of checking and regulating clinical labs to keep them safe and reliable.
- BHFS is responsible for checking, regulating, and ensuring that healthcare facilities (like hospitals, clinics, and clinical laboratories) follow proper standards.
Who enforces the rules for clinical laboratories?
The Department of Health (DOH) through the Bureau of Health Facilities and Services (BHFS)
What is the main purpose of RA 4688
To promote and protect public health by ensuring clinical labs are properly managed and meet quality standards.
By making sure they have enough resources, follow standards, and perform tests accurately.
What types of facilities must follow these regulations and what kinds of human samples do clinical labs test?
section 4: scope
All clinical laboratories that test human samples for diseases or health conditions.
Blood, urine, tissue, secretions, excretions, radioactive materials, and other body fluids.
Which government labs are excluded from these rule?
Labs that only perform:
Acid-fast bacilli (AFB) microscopy (for tuberculosis)
Malaria screening
Cervical cancer screening
(as long as they are part of a licensed government clinical lab)
[These government labs must be connected to a licensed government clinical laboratory to be exempt from the rules.]
classification of laboratories
section 5
1.ownership
- Government clinical laboratories
- Private clinical laboratories
- function
- Clinical Pathology
- Anatomic Pathology - institutional character
- hospital-based laboratories
- non-hospital-based laboratories/ freestanding lab - service capability
- primary
- secondary
- tertiary
policies
section 6
- An approved permit to construct and design layout of a clinical laboratory shall be secured from the BHFS prior to submission of an application for a Petition to Operate.
- No clinical laboratory shall be constructed unless plans have been approved and construction permit is issued by the BHFS.
- A clinical laboratory shall operate with a valid license issued by BHFS/CHD, based on compliance with the minimum licensing requirements.
- The clinical laboratory shall be organized and managed to provide effective and efficient laboratory services.
- The clinical laboratory shall provide adequate and appropriate safety practices for its
personnel and clients. - An approved permit to construct and design layout of a clinical laboratory shall be secured from the BHFS prior to submission of an application for a Petition to Operate.
- No clinical laboratory shall be constructed unless plans have been approved and construction permit is issued by the BHFS.
- A clinical laboratory shall operate with a valid license issued by BHFS/CHD, based on
compliance with the minimum licensing requirements. - The clinical laboratory shall be organized and managed to provide effective and efficient laboratory services.
- The clinical laboratory shall provide adequate and appropriate safety practices for its personnel and clients.
[Get approval first before building.
No permit = No construction 🚫
No license = No operation 🚫
Labs must be properly managed ✅]
Requirements and Procedures for Application of Permit to Construct and License to Operate
section 7
1️⃣ Applying for a Permit to Build a Clinical Laboratory
Before starting construction, you must:
✔ Write a Letter of Application to the BHFS Director.
✔ Submit 4 copies of site and floor plans (approved by an architect/engineer).
✔ Provide DTI or SEC registration (for private labs).
2️⃣ Applying for a New License to Operate
To officially open the laboratory, you must:
✔ Fill out a notarized application form called “Petition to Establish, Operate, and Maintain a Clinical Laboratory”.
✔ Submit the application to BHFS.
3️⃣ Renewing a License
To continue operating, you must:
✔ Fill out a notarized application form for renewal of the license.
✔ Submit it to the Center for Health Development (CHD) in your region.
renewal of license
permit and license fee
penalties
inspection and monitoring
issuance of license
1️⃣ Renewal of License
Must apply for renewal 90 days before the license expires.
The application period depends on your region:
NCR → January to March
Regions 1, 2, 3, CAR → February to April
Regions 4, 5, 6 → March to May
Regions 7, 8, 9 → April to June
Regions 10, 11, 12, CARAGA, ARMM → May to July
2️⃣ Permit and License Fees
There is a non-refundable fee for:
✅ Permit to construct a lab
✅ License to operate a lab
✅ Renewing a license
Fees must be paid at BHFS/CHD following DOH’s official rates.
3️⃣ Penalties for Late Renewal
₱1,000 penalty if renewal is late (within 2 months after expiry).
Extra ₱100 per month after 2 months.
4️⃣ Inspections & Monitoring
BHFS/CHD inspectors can check labs anytime.
Labs must be inspected every 2 years or when necessary.
Records should be available for monitoring compliance.
5️⃣ Issuance of License
CHD Director (or representative) issues the license if requirements are met.
License is valid for 1 year and must be renewed annually.
terms and conditions of license
The license is granted upon compliance with the licensing requirements
* It is NON-TRANSFERABLE
* The owner or authorized representative of any clinical lab desiring to transfer a licensed clinical lab to another location shall inform the CHD in writing at least 15 days before the actual transfer. It is also subject for re-inspection and shall comply with the licensing requirements.
* An extension laboratory shall have a separate license
* Any change affecting the substantial condition of the LTO a lab shall be reported within 15 days in writing by the person concerned to the BHFS/CHD for notation and approval. Failure to do so will cause the revocation of the license of the clinical laboratory.
* The clinical laboratory licensed must be placed in a conspicuous location within the laboratory.
violations
🚫 Operating a lab without a certified pathologist or registered medical technologist.
🚫 Changing ownership, location, or staff without informing BHFS/CHD.
🚫 Refusing inspections from BHFS/CHD officials.
🚫 Gross negligence (serious carelessness in lab operations).
🚫 Any action harmful to the public.
Investigation of Charges or Complaints
How Complaints Are Investigated:
Punishment for Operating Without a License:
Closure of Illegal Labs:
section 9
🕵️ How Complaints Are Investigated:
BHFS/CHD (health authorities) will investigate if a lab or its staff is violating the law.
If found guilty, the lab’s license and the responsible person’s authority may be suspended or revoked.
Authorities can also take legal action (criminal charges).
⚖ Punishment for Operating Without a License:
Imprisonment: 1 month to 1 year
Fine: ₱1,000 to ₱5,000
Both (depending on the court’s decision).
If the offender is a company, the owner or manager will be punished.
🚫 Closure of Illegal Labs:
Labs operating without a valid license will be closed immediately by BHFS/CHD.
Authorities can ask police help to shut down illegal labs.
No court order can stop the DOH from closing a lab that violates the law.
Modification and Revocation of
License
When Can a Lab’s License Be Taken Away?
Process Before Revocation:
Immediate Action for Serious Violations:
section 10
🚨 When Can a Lab’s License Be Taken Away?
If the lab lied on its application.
If inspections show violations of the rules.
If the lab fails to follow the law or terms of its license.
📢 Process Before Revocation:
The lab must be informed before any action is taken.
An investigation will be conducted before suspending or revoking the license.
⚠ Immediate Action for Serious Violations:
If the lab keeps breaking rules or puts public health at risk, the license can be revoked immediately.
Repealing clause
section 11
- These rules and regulations shall supersede all other previous official
issuances hereof.
[These new rules replace all older rules and regulations about the same topic = ensures that only the latest version of the rules is followed]
Publication of List of Licensed Clinical Laboratories
section 12
- Every year, a list of officially licensed clinical laboratories is published in a widely read newspaper.
The list is also available online at http://ncroffice.doh.gov.ph/RLED/Details. - Helps the public identify legal and licensed labs.
- Prevents people from using unlicensed or illegal laboratories.
[A public list of approved labs is released every year to ensure transparency and safety.]
Effectivity
section 13
The new rules will officially start 15 days after they are published in:
- The Official Gazette (a government publication)
- A widely read newspaper.
*gives time for people to become aware of the new rules before they take effect.
what are the technical standards and minimum standards
staffing
physical facilities
equipment/ instruments
glassware/ reagents/ supplies
- provide adequate and appropriate glass wares, reagents and supplies necessary to undertake the required services.
waste management
- adequate and efficient disposal of waste following the guidelines of the DOH and the local government.
quality control program
reporting
recording
laboratory fees
operated and maintained, partially or wholly, by the national government, local government unit, or any other political unit or any department, division, board or agency.
government clinical laboratories
owned, established, and operated by an individual, corporation, association, or organization.
private clinical laboratories
difference between Clinical Pathology and Anatomic Pathology
- Clinical Pathology:
- clinical chemistry
- hematology
- immunohematology
- microbiology
- immunology
- clinical microscopy
- histopathology
- cytology,
- toxicology
- molecular biology
- cytogenetics
- toxicology
- therapeutic drug monitoring
- Anatomic Pathology [CAS.MIF]
- cytology
- autopsy
- surgical pathology
- molecular pathology
- immunohistopathology
- forensic pathology
[differences:
🔬 Clinical Pathology – Focuses on body fluids (like blood, urine, and saliva). It uses laboratory tests to check for diseases.
🩸 Anatomic Pathology – Focuses on tissues and organs. It examines samples under a microscope to look for diseases like cancer.
Clinical Pathology = Fluids & Lab Tests
Anatomic Pathology = Tissues & Microscopes
*Cells can be studied in both Clinical Pathology and Anatomic Pathology, but in different ways]
hospital-based laboratories vs non-hospital-based laboratories
🔹 Hospital-Based Laboratory
A laboratory that is inside a hospital and mainly serves the hospital’s patients.
✅ Example: A blood test lab in a hospital that checks patients’ sugar levels or infections.
🔹 Non-Hospital-Based (Freestanding) Laboratory
A laboratory that operates independently and is not inside a hospital. It serves the general public and private patients.
✅ Example: A diagnostic clinic where people go for medical tests like X-rays, blood tests, or urine tests, even if they are not admitted to a hospital.
👉 Easy way to remember:
Hospital-Based = Inside hospital, for hospital patients 🏥
Freestanding = Outside hospital, for everyone 🚶
service capability for each classification
PRIMARY
- routine hematology
- routine fecalysis
- blood typing
- quantitative platelet determination
SECONDARY
- PRI
- routine clinical chemistry
- crossmatching
TERTIARY
- SEC
-special chem
- special hematology
- immunoserology
- microbiology
Who Reports Violations?
Provincial, city, and municipal health officers must report:
✔ Unlicensed clinical labs
✔ Private individuals performing lab tests without a license
✔ Any lab violating these rules
Staffing Requirements for Clinical Laboratories
- Who manages the lab?
A licensed physician who is certified by the Philippine Board of Pathology.
If no pathologist is available, a physician with at least 3 months of training in lab medicine, quality control, and lab management can manage Primary or Secondary category labs. - Medical Technologists (MedTechs):
The lab must have enough registered medical technologists to handle the workload.
A MedTech must always be available during operating hours. - Training & Education:
The lab must provide continuous training and staff development to improve the skills and knowledge of the personnel.
Physical Facility Requirements for Clinical Laboratories
General Requirements:
Minimum Space Requirements:
General Requirements:
The lab must be clean, safe, well-ventilated, and well-lit.
The working space should be big enough to allow smooth workflow.
There must be a reliable water supply.
Minimum Space Requirements:
Primary Lab → 10 sq. meters
Secondary Lab → 20 sq. meters
Tertiary Lab → 60 sq. meters (must include a separate, enclosed, and well-ventilated microbiology room)
Equipment Requirements for Clinical Laboratories
The lab must have enough equipment and the right types to perform all required tests.
All equipment must meet safety standards.
If the lab offers extra tests, it must have the proper equipment for those procedures.
(table in ppt)
Quality Control Program for Clinical Laboratories
- Internal Quality Control (Inside the Lab)
✅ Staff should be regularly trained and tested.
✅ Use proper testing methods, chemicals, and equipment.
✅ Maintain and monitor all machines regularly.
✅ Use quality control samples to verify accuracy. - External Quality Control (Checked by Outside Experts)
✅ Labs must join external quality tests conducted by National Reference Laboratories.
✅ A satisfactory performance rating is needed to renew the lab’s license.
✅ Labs that refuse to join external tests may have their license suspended or revoked.
- Reporting
- Recording
- Laboratory Fees
for Clinical Laboratories
REPORTING (How Lab Results Are Given)
✅ Lab test results are part of a discussion between the doctor and the pathologist.
✅ All test results must have the names and signatures of a registered medical technologist and a pathologist.
✅ No one in the lab can give out results without the pathologist’s approval, except in emergencies.
RECORDING (Keeping Track of Test Results)
✅ Every test request and result must be properly recorded.
✅ There should be a system for filing, storing and accession of all reports.
✅ Test records must be kept for at least 1 year.
✅ Anatomic and forensic pathology records must be kept permanently.
LABORATORY FEES (Cost of Tests)
✅ Fees should be reasonable and based on usual rates in the area.
✅ The cost of lab tests and the professional fees of doctors are charged separately.
