29 Questions
What is the significance of the LTO in a clinical laboratory setup?
It is a temporary permit required for the operation of a laboratory.
Why is an ideal laboratory setup important?
To facilitate efficient testing processes and accurate results.
What is the minimum floor area requirement for a secondary clinical laboratory?
25 sq. meters
Can the License to Operate (LTO) be temporarily lent to a newly established clinical laboratory?
No
Is a satellite clinical laboratory exempted from obtaining a license if it is in a different location from its central laboratory?
No, it still requires a separate license.
Who must be professionally in-charge of a registered clinical laboratory?
A licensed physician
What is the penalty for violations related to operating and maintaining a clinical lab?
Imprisonment less than 1 month
Who is authorized to issue rules and regulations regarding clinical lab operations?
Secretary of Health
Under what condition is a government hospital lab exempted from registering and securing a license at the office of the Secretary of Health?
If their services are extensions of government regional or central lab
What is the required amount for the registration fee of a clinical lab?
$50,000
When was this regulation approved?
June 18, 1966
What action will be taken if a clinical lab fails to correct deficiencies after due notice?
Investigate the complaint and verify guilt
When will the regulations come into effect?
15 days after publication in the official Gazette
What is the consequence of declaring a rule invalid?
Repeal or amendment of inconsistent rules
Who is authorized to investigate complaints against clinical labs or their personnel?
Any person or interested party
Which document governs the establishment and operation of clinical labs in the Philippines?
Admin O #59 s. 2001
How long is the period of suspension that can be imposed for violating the regulations?
Indefinite period
What is the main purpose of the Rules and Regulations governing the accreditation of Clinical Laboratories for the training of Medical Technologist Interns?
To ensure that only accredited Clinical Laboratories can train Medical Technologist Interns.
Who is responsible for the regulatory authority over the accreditation of Clinical Laboratories for the training of Medical Technologist Interns?
Department of Health through the Bureau of Research and Laboratories
What is one of the requirements for a Clinical Laboratory to be accredited for training Medical Technologist Interns?
Reporting a volume of exams performed in the previous year/section.
Who is authorized to sign the application for accreditation for a Clinical Laboratory?
The owner or an authorized representative.
What happens if a Clinical Laboratory applies for renewal of accreditation 100 days after expiration?
They face a non-refundable penalty.
What action must be taken by Health Officers if they discover an unaccredited Clinical Laboratory training Medical Technologist Interns?
Report it to Regional Health Office, Provincial, or Municipal officers.
What program should the lab have for staff development?
Staff development and continuing education
Which of the following is a requirement for equipment in the lab?
Calibration, preventive maintenance, and repair program
What is necessary for glass wares, reagents, and supplies in the lab?
Being stored under specific conditions
Which signature is required on all lab results?
Both the pathologist's facsimile signature and RMT's name
Which QA program should the lab participate in?
External Quality Assurance Program administered by NRL
What is the responsibility of the Board of Pathology Head?
Technical supervision of the lab activities
Test your knowledge on clinical laboratory laws by answering questions related to laboratory setup, revised rules, and regulations. Identify the acronyms commonly used in the field and assess your understanding of key concepts.
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