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CLINICAL

LABORATORY
LAWS

REPUBLIC ACT NO. 4688

An act regulating the operation and
maintenance of clinical laboratories
and requiring the registration of the
same with the department of health
providing penalty for the violation
thereof, and for other purposes.

SECTION 1
 Any person, operating and maintaining a
clinical laboratory shall register and secure a
license annually at the office of the secretary
of health: provided, that government hospital
laboratories doing routine or minimum
laboratory examinations shall be exempt
from the provisions of this section if their
services are extensions of government
regional or central laboratories.

. SECTION 2  It shall be unlawful for any person to be professionally in-charge of a registered clinical laboratory unless he is a licensed physician duly qualified in the laboratory medicine and authorized by the Secretary of Health. such authorization to be renewed annually.

as provided for in the preceding paragraph. No license shall be granted or renewed by the Secretary of Health for the operation and maintenance of a clinical laboratory unless such laboratory is under the administration. direct and supervision of an authorized physician. .

through the bureau of research and laboratories shall be charged with the responsibility of strictly enforcing the provisions of this Act and shall be authorized to issue such rules and regulations as maybe necessary to carry out its provisions. SECTION 3  The Secretary of Health. .

at the discretion of the court. . or by a fine of not less than one thousand pesos nor more than five thousand pesos. SECTION 4  Any person. firm or corporation who violates any provision of this Act or the rules and regulations issued there under by the Secretary of Health shall be punished with imprisonment for not less than one month but not more than one year. or both such fine and imprisonment .

SECTION 5  If any section or part of this act shall be adjudged by any court of competent jurisdiction to be invalid. . impair. or invalidate the remainder thereof. the judgment shall not affect.

is hereby authorized to be appropriated. to carry into effect the provisions of this Act. out of many funds in the National Treasury not otherwise appropriated. SECTION 6  The sum of fifty thousand pesos. . or so much thereof as may be necessary.

. SECTION 7  All Acts or parts of Acts which are inconsistent with the provisions of this Act are hereby repealed.

1966 . SECTION 8  This Act shall take effect upon its approval. Approved: June 18.

274 SERIES OF 1976 27 January 1976 .ADMINISTRATIVE ORDER NO.

SUBJECT: Rules and Regulations Governing Affiliation of Medical Technology Schools. Colleges and Universities in Government Hospitals under the Department of Health. .

Responsibilities of the Department of Health and Laboratories .

4688.Laboratories designated by the Secretary of Health where medical technology interns may Affiliate must meet the following requirements: 1. 2.A. blood banking. microbiology. The laboratory should be duly licensed as specified by the law on clinical laboratories. and serology and histopathology. clinical microscopy. hematology. The position of medical technologist should be provided for each of the sections of clinical chemistry. R. .

5. Each section of the laboratory can be utilized for training only if it can accommodate at least 2 interns at any one time. There should be sufficient equipment and supplies necessary depending on the volume and type of examinations as well as the number of interns to be trained by the laboratory. .3. 4. There should be an adequate laboratory space to accommodate both the staff and the medical technology interns.

) The person responsible for this program should be a member of the specialty society in laboratory medicine b.) The training program should be prepared in coordination with the training officer of the hospital or health region and submitted to the Committee on Affiliation with the contract of Affiliation. The laboratory should have a training program for medical technology interns. a.6. .

(8)lectures. (7)time schedule. d. (5)required quota of tests to be performed to develop accuracy and precision. (3)principles that go with the method. (9) methodology of training.c. (2) methods or procedures to be taught. (4) right work attitudes and ethical values. .) The program should include the (1) objective training. seminars and conferences.) The program should provide for an objective measure or evaluation of the baseline skills and knowledge prior to allowing or utilizing interns to handle actual specimens from patients. (6)objective evaluation performance in each section.

7. The minimum number of examinations or samples of each section to accommodate interns areas follows: a. Clinical Chemistry – 3000 exam/annum b. Parasitology(direct fecal smear and concentration test or katothick smear) – 1500 sample/annum . Urinalysis (complete analysis) – 1500 samples/annum 2. Clinical microscopy 1.

Isolation and identification of organisms – 1000 samples/annum d. acid test staining. white cell count. hematocrit. and red cell morphology or CBC – 1200 samples/annum 2. schilling. Gram – staining. Peripheral blood study to include hemoglobin. bleeding and clotting time. Hematology 1.c. Microbiology 1.800 samples/annum 2. platelet count. and other tests – 800 samples/annum . Sedimentation rate. malarial smears.

Serology VDRL – 300 tests/annum Widal test – 300 tests/annum f. Typing – 900 tests/annum 2. Blood Banking and Serology 1.e. Complete cross-matching – 600 tests/annum 3. Histopathology– 500 tissues/annum Cytology – 500 tissues/annum .

At least one member of the professional staff of the laboratory to every group of interns not exceeding 10 in each section should be provided 9. The staff and personnel of the laboratory will be assisted by a laboratory instructor experienced in actual laboratory work from the sending University or College to assist especially to monitor individual attendance . behavior. .8. performance of the students including guidance in readings and application to the theoretical knowledge taken up in school to actual practice.

No intern is to be assigned without the regular professional staff of the laboratory on duty at the same time.10. . No more than 10 medical technology shall be allowed to train during the night shift in understaffed hospitals and so certified by the director of the same. such interns should have medical technologist work with them. The allotment derived from the intern’s affiliation fee for the laboratory must be spent for the laboratory needs utilized exclusively for training and not for payment of furniture or appliances of the laboratory. 11.

The director of the hospital is responsible for the admission of the number of interns approved by the Committee. 13. He should not enter into any contract of affiliation with any college.12. .Priority should be given to interns residing within the area or region of the hospital. university or school for medical technology if any of the conditions set forth in this Administrative Order are not complied with.

Responsibilities of the Affiliating Universities/Scho ols/ Colleges/ of Medical Technology .

498. 5527 and Presidential Decree No. Approval from the Department of Education and the Board of Medical Technology. Compliance with the provisions of R. . 2.A.Requirements before applying for Affiliation to any clinical laboratory of DOH: 1.

Provide a laboratory instructor experienced in actual laboratory work to monitor individual attendance. behavior and performance of the students including guidance in readings and application of theoretical knowledge obtained from school to actual practice and to assist the pathologist and professional staff in implementing the approved training program for the duration of the training of interns. schools. . and colleges shall: 1.These universities.

breakage or losses by the medical technology interns of laboratory property.2. 4. . 3. equipment supplies. Payment is done within the first five days of the month. Pay or replace damage. See to it that all medical technology interns before beginning the internship of any section must have completed the theoretical aspect of that particular section. Pay the hospital 35 pesos for each intern each month.

Contracts shall be subject for renewal every school year by the Chief Hospital. through the chairman. Accreditation Committee on Training and Student Affiliation. . Make a request for affiliation to the Chief of the hospital accomplishing the appropriate standard form of contract of affiliation (6 copies) and coursed through paper channels to the Secretary of Health.5.

and regulations of the hospital and that discipline is maintained at all times. See to it that the laboratory instructor and students observe and abide with the policies.6. . See to it that the students and instructor are in their proper uniforms and provided with laboratory gowns. rules. 7.

Schools and Colleges of Medical Technology and the Laboratories.Joint Responsibilities of Affiliating Universities. .

school or college assigned to the laboratory for the duration of the internship of their respective students.1. . staff and personnel of the laboratory and the laboratory instructor of each university. The training program shall be prepared by the pathologist-in-charge of the laboratory in coordination with the training officer of the hospital. Its implementation shall be the joint responsibility of the pathologist.

Hematology – 2 months e. The internship schedule shall be properly apportioned to the different section of the laboratory service as follows: a. Blood Banking and Serology – 1 month f. Clinical chemistry – 2 ½ months b.2. Histopathology – 1 month . Microbiology(bacteriology) – 2 ½ months d. Clinical microscopy ( Urinalysis and Parasitology) – 3 months c.

3. A monthly conference should be held to evaluate the implementation of the program and institution of changes by the pathologist. laboratory instructor and staff of the laboratory and for problems that might arise during the implementation. 4. Maintenance of cooperation and harmonious working relations at all times among the students and staff of the hospital. . This Administrative Order supersedes all issuances on this matter and shall take effect immediately.

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