Clinical Laboratories Flashcards
An act regulated the operation and maintenance of clinical laborayories and requiring the registration of the same with the department of health, providing penalty for the violation thereof, and for other purposes
R.A. No. 4688
Duly qualified in laboratory medicine and authorized by the Secretary of Health
Licensed physician
Any person who violates this Act shall be punished with
1 month to 1 year imprisonment or a fine of 1k to 5k or both
RA. No. 4688 was approved on
June 18, 1966
New rules and regulations governing the regulation of clinical laboratories in the Philippines
DOH Administrative Order No. 2021-0037
R.A. No. 4688 s. 1966 was mandated through
Bureau of Medical Services
Bureau of Medical Services is now known as the
Health Facilities and Services Regulatory Bureau
Revised rules and regulations governing the licensure and regulation of clinical laboratories in the Philippines
A.O No. 2007-0027 dated August 22, 2007
Rules and regulations governing the licensure of Primary Care Facilities in the Philippines
A.O. No. 2020-0047
Universal Health Care Act
R.A. No. 11223
BARMM
Bangsamoro Autonomous Region in Muslim Mindanao
HFSRB
Health Facilities and Services Regulatory Bureau
Bangsamoro Organic Act
R.A No. 11054
Refers to any natural juridical person, government instrumentalities/agencies, partnership, corporation or agency seeking a license to operate and maintain a clinical laboratory
Applicant
The checklist which prescribes the minimum standards and requirements for licensure of a clinical laboratory.
Assessment tool
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.
Clinical Laboratory
A formal authorization issued by the DOH to an individual partnership, corporation, association, or any government agency / unit seeking to perform laboratory tests in compliance with the requirements prescribed in this order
DOH-LTO
A permit issued by DOH to an applicant who will establish and operate a hospital or other health facility; It is a prerequisite for License to Operate.
DOH-PTC
A program where participating CL are given unknown samples for analysis. These samples should be treated as ordinary human specimens for the usual processing and examination. The quality of performance of the CL shall be assessed through the closeness of its results through a pre determined value or reference value generated by the participating CL through peer group analysis
EXTERNAL QUALITY ASSESSMENT PROGRAM (EQAP)
A laboratory testing unit capable of performing limited CL diagnostic procedures. It moves from one testing site to another, and it has a DOH-license CL as its main laboratory
MOBILE CLINICAL LABORATORY
An EQAP activity conducted by the National Reference Laboratories to assess the quality performance and accuracy of the results of laboratories.
NATIONAL EXTERNAL QUALITY ASSESSMENT SCHEME (NEQAS)
Refers to a Doctor’s office/clinic wherein CL examination are performed for the purpose of monitoring the Doctor’s patient only, wherein NO official results shall be issued.
PHYSICIAN’S OFFICE LABORATORY (POL)
Refers to diagnostic testing done at or near the site of patient care rather than the CL. It may be in the emergency room, operating suites, wards, and ambulances
POINT-OF-CARE TESTING (POCT)
Refers to an extension of the main CL located within the facilities, compound or premises. It shall have the same service capability as the main laboratory.
SATELLITE CLINICAL LABORATORY (SCL)
Refers to CL tests that are either sent out or outsourced to other DOH licensed CL withthe same or higher service capability
REFERRAL TEST
Classification by Ownership
• Government
• Private
Classification by Institutional Character
• Institution-based
• Non-institution-based
Classification by Function
• Clinical Pathology
• Anatomic Pathology
• Molecular Pathology
Also known as Guidelines in the Application for Department of Health Permit to Construct (DOH-PTC)
A.O. NO. 2016-0042
Guidelines on the Anual Cut-off Dates for Receipt of Complete Applications for Regulatory Authorizations Issued by the Department of Health
A.O. NO. 2019-0004
April 30, 2019
DOH A.O. NO. 2021-0037 was adopted on?
June 11, 2021
Sgd. Francisco T. Duque III, MD, MSc.
“Implementation of External Quality Assessment as a Regulatory Requirement for Licensing of Clinical Laboratories”
DOH DPEARTMENT MEMORANDUM NO. 2009-0086-B
DOH D.M. NO. 2009-0086 was issued on
September 8, 2014
Sgd. ATTY. NICOLAS B. LUTERO III, CESO III
Certificate issued after submission of test results.
Certificate of Participation
Certificate issued after passing the prescribed rating set by respective NRL providers.
Certificate of Proficiency
