Chapter I
GENERAL PROVISIONS
Article 1. Scope and regulated entities
1. This Circular provides guidelines for management of medical testing and tasks of positions involved in medical testing.
2. Tests mentioned in this Circular include tests on hematology, blood transfusion, biochemistry, microbiology, parasitology, anapathology, immunology, medical genetics, molecular biology, endocrinology, allergology, oncology, cytology and other tests (hereinafter referred to as “tests”).
3. This Circular applies to health facilities and other facilities involved in medical testing.
Article 2. Definitions
For the purposes of this Circular, the terms below shall be construed as follows:
1. “point of care testing or near patient testing” means a test carried out by a health worker outside a laboratory environment and applied at an emergency or screening facility to serve patient monitoring and primary healthcare.
2. “quick test or rapid test” means a test that gives results within a short period of time after it is done and is often used in point of care testing.
Article 3. Forms of organizations involved in testing
1. Laboratory departments in charge of each type of test.
2. Laboratory departments and centers in charge of various tests.
3. Laboratory departments in cooperation with other paraclinical departments.
4. Independent laboratories licensed to operate as prescribed in Article 28 of the Government’s Decree No. 109/2016/ND-CP dated July 01, 2016.
5. Medical stations of communes, clinics and other forms prescribed by law.
The forms mentioned in Clauses 1, 2, 3 and 4 of this Article are referred to as laboratory departments.