RA NO. 4688, AO NO. 59s. 2001 Flashcards
What does Republic Act No. 4688 regulate?
The operation, maintenance, and registration of clinical laboratories in the Philippines.
What must all clinical laboratories in the Philippines do according to Section 1 of R.A. 4688?
Register and secure a license annually at the office of the Secretary of Health.
Who can be in charge of a clinical laboratory as per Section 2?
A licensed physician duly qualified in laboratory medicine and authorized by the Secretary of Health.
What is the consequence of violating the provisions of R.A. 4688 under Section 4?
Punishment with imprisonment for 1 month to 1 year, or a fine of ₱1,000 to ₱5,000, or both.
What is the title of Administrative Order No. 59 s. 2001?
Rules and Regulations Governing the Establishment, Operation, and Maintenance of Clinical Laboratories in the Philippines.
What does Section 5 of R.A. 4688 state about the validity of the act?
If any part of the Act is judged invalid, the judgment does not affect the rest of the Act.
How much is appropriated to implement the provisions of R.A. 4688 as per Section 6?
₱50,000 from the National Treasury.
When was R.A. 4688 approved?
June 18, 1966.
What is the purpose of the rules in Administrative Order No. 59 s. 2001 as per Section 3?
To protect and promote health by ensuring properly managed clinical laboratories with effective performance.
What does Section 2 of Administrative Order No. 59 s. 2001 pertain to?
The authority to implement R.A. 4688, as well as E.O. 102 s. 1999.
What laboratories are excluded from the scope of Section 4 of A.O. No. 59 s. 2001?
Government laboratories limited to acid-fast bacilli microscopy, malaria screening, and cervical cancer screening.
What are the classifications by function in Section 5 of A.O. No. 59 s. 2001?
Clinical Pathology and Anatomic Pathology.
What are the classifications by institutional character under Section 5?
Hospital-based and non-hospital-based laboratories.
What services must a primary laboratory provide as per Section 5?
Routine Hematology, Urinalysis, Fecalysis, Blood Typing, and Quantitative Platelet Determination.
What services must a secondary laboratory provide as per Section 5?
Primary laboratory services and Routine Clinical Chemistry and Crossmatching.
What additional services must a tertiary laboratory provide as per Section 5?
Special Chemistry, Special Hematology, Immunology/Serology, and Microbiology.
What is required before constructing a clinical laboratory as per Section 6 of A.O. No. 59 s. 2001?
An approved permit to construct and design layout from BHFS.
What documents are required to apply for a permit to construct a clinical laboratory?
A letter of application, four sets of site development and floor plans, and DTI/SEC registration for private laboratories.
How often must a clinical laboratory’s license be renewed as per Section 7?
Every year
What is the penalty for late renewal of a clinical laboratory license?
₱1,000 if filed within 2 months after expiration, with an additional ₱100 per month beyond that.
How often must clinical laboratories be inspected according to Section 6?
Every 2 years or as necessary.
What happens to clinical laboratories that refuse to be inspected as per Section 8?
Their licenses may be suspended or revoked.
What must a clinical laboratory make available for inspection?
Premises, facilities, and records of laboratory examinations.
Who is responsible for reporting unlicensed clinical laboratories?
Provincial, City, and Municipal Health Officers.
What is required in laboratory reports under Section 7 of A.O. No. 59 s. 2001?
The name and signature of the registered medical technologist and the Pathologist.
What must be included in a clinical laboratory’s internal quality control program?
Competency assessment for personnel, standard laboratory methods, equipment maintenance, and quality control reference materials.
What is the purpose of the External Quality Control Program under Section 6?
Participation in a National Reference Laboratory’s program is necessary for license renewal.
How long should clinical laboratory records be kept as per Section 8?
For at least 1 year; anatomic and forensic pathology records must be kept permanently.
What must clinical laboratories comply with regarding waste management?
Adequate and efficient disposal of waste per DOH guidelines.
How must laboratory fees be determined according to Section 9?
Based on prevailing rates and quality control of laboratory procedures.
What must a clinical laboratory do before transferring to a new location?
Notify the CHD at least 15 days before transfer and comply with licensing requirements for the new location.
What are the conditions for modifying or revoking a laboratory’s license as per Section 10?
Violations of the terms, material false statements, or public health interests.
What must be reported if a clinical laboratory changes ownership or location?
The changes must be reported to BHFS/CHD within 15 days.
What is the penalty for operating a clinical laboratory without a proper license?
Imprisonment for 1 to 12 months, or a fine of ₱1,000 to ₱5,000, or both.
How long must a clinical laboratory file reports?
At least 1 year for general records; permanently for anatomic and forensic pathology.
How must laboratory results be released?
Only with the directive of the Pathologist, except in emergencies.
What constitutes a violation under Section 8 of A.O. No. 59 s. 2001?
Operating without a certified pathologist, change of personnel or location without notification, refusal of inspection, and gross negligence.
How often must the list of licensed clinical laboratories be published?
Annually, in a newspaper of general circulation.
What should a clinical laboratory’s quality assurance program include?
Both internal and external quality control procedures.
What must be included in the staffing of a clinical laboratory?
A licensed physician and a sufficient number of registered medical technologists.
What must the physical facilities of a clinical laboratory include?
Adequate lighting, ventilation, cleanliness, and safety, with sufficient space for operations.
How many square meters must a primary clinical laboratory have?
At least 10 square meters.
What types of equipment must a clinical laboratory provide?
Appropriate equipment for all the activities and laboratory examinations being performed.
What is the minimum space requirement for a secondary clinical laboratory?
At least 20 square meters.
What is the minimum space requirement for a tertiary clinical laboratory?
At least 60 square meters.
What is required for a laboratory to maintain its license according to Section 9 of A.O. No. 59 s. 2001?
Compliance with licensing requirements, and the license must be placed in a conspicuous location within the laboratory.
What happens if a clinical laboratory changes its substantial conditions without informing BHFS/CHD?
The laboratory’s license may be revoked.
What happens if a clinical laboratory refuses to participate in the External Quality Assurance Program?
Its license can be suspended or revoked.
Who is authorized to inspect clinical laboratories?
The Director of BHFS/CHD or their duly authorized representatives.
What must be done before opening a clinical laboratory?
Secure a license from BHFS/CHD and comply with all requirements including a permit to construct.
How often should clinical laboratories participate in the External Quality Assurance Program?
Regularly, as a requirement for license renewal.
What should laboratory staff undergo to ensure compliance with quality standards?
Continuous competency assessments and training programs.
What must be available in a clinical laboratory in terms of supplies?
Adequate and appropriate glassware, reagents, and supplies for all laboratory procedures.
What is the role of the National Reference Laboratories in clinical laboratory operations?
They provide External Quality Assurance Programs to assess laboratory performance.
What constitutes “gross negligence” in the operation of a clinical laboratory?
Any act or omission detrimental to the public’s health and safety.
What must be done to renew a clinical laboratory’s license?
Submit a notarized application form “Application for Renewal of License” within 90 days before the license expires.
How long must anatomic and forensic pathology records be kept?
Permanently in the laboratory.
What happens to a laboratory’s license if its ownership changes?
The change must be reported to BHFS/CHD, or the license may be revoked.
What must a clinical laboratory do if it transfers to a new location?
Notify BHFS/CHD at least 15 days before the transfer and undergo a re-inspection.
What happens if a clinical laboratory is found to have made a false statement in its license application?
Its license may be suspended, revoked, or modified.
What is the penalty for clinical laboratories operating without a valid license?
Imprisonment for 1 to 12 months, or a fine between ₱1,000 and ₱5,000, or both.
How often must clinical laboratory records be made available for inspection?
At any reasonable time, upon request from BHFS/CHD representatives.
What actions are grounds for suspension or revocation of a clinical laboratory license?
Violations of R.A. 4688 or any associated rules and regulations.
What are the qualifications for a physician managing a clinical laboratory?
A licensed physician certified by the Philippine Board of Pathology, or with three months’ training in laboratory medicine where pathologists are unavailable.
What are the responsibilities of the Secretary of Health regarding clinical laboratories?
Enforcing the provisions of R.A. 4688 and issuing necessary rules and regulations.
What must be included in laboratory reports?
The name of the registered medical technologist and the Pathologist, both duly signed.
What happens if a clinical laboratory’s license is revoked or canceled?
The laboratory will be summarily closed, and law enforcement may assist in its closure.
What happens if a clinical laboratory continues to operate after its license is revoked?
It may face criminal prosecution, and its closure cannot be stopped by a restraining order.
What must be done when a laboratory report is issued in emergency cases?
The report can be released under the authorization of the Pathologist.
What actions should a laboratory take for proper waste disposal?
Follow the Department of Health and local government guidelines for waste management.
How long should clinical laboratory records be kept for routine procedures?
At least 1 year for routine laboratory records.
What should a clinical laboratory do if an inspection identifies violations?
Correct the violations to avoid suspension or revocation of its license.
What are the staffing requirements for hospital-based clinical laboratories?
At least one registered medical technologist per shift must be available to cover the laboratory operations.
What constitutes a “non-hospital-based laboratory”?
A laboratory that operates independently of a hospital.
What does Section 13 of Administrative Order No. 59 s. 2001 specify?
The rules and regulations take effect 15 days after publication in the Official Gazette or a newspaper of general circulation.
What should be included in the site and floor plans when applying for a permit to construct a clinical laboratory?
The plans must be approved by an architect or engineer.
What happens if a clinical laboratory is found guilty of the charges after investigation?
Its license may be suspended, canceled, or revoked, and legal actions may be taken.
