MT 27: RA 4688

Lesson 5

CLINICAL LABORATORY ACT OF 1966

RA 4688 is also known as the...?

JUNE 18, 1966

RA 4688 was approved on..?

RA 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

TITLE

What is section 1 of RA 4688?

Section 1 (TITLE)

Any person, firm or corporation, operating and maintaining a clinical laboratory in which body fluids, tissues, secretions, excretions and radioactivity from beings or animals are analyzed for the determination of the presence of pathogenic organisms, processes and/or conditions in the persons or animals from which they were obtained, shall register and secure a license ANNUALLY at the OFFICE OF THE SECRETARY OF HEALTH.

ANNUALLY,  OFFICE OF THE SECRETARY OF HEALTH

Section 1: TITLE

Any person, firm or corporation, operating and maintaining a clinical laboratory in which body fluids, tissues, secretions, excretions and radioactivity from beings or animals are analyzed for the determination of the presence of pathogenic organisms, processes and/or conditions in the persons or animals from which they were obtained, shall register and secure a license ___ at the _____

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

government regional or central laboratories

Government hospital laboratories doing routine or minimum laboratory examinations shall be exempt from the provisions of this section (RA 4688) if their services are extensions of _____ ____ or ____ ____

AUTHORITY

What is section 2 of RA 4688?

Licensed physician or someone authorized by the Secretary of Health

According to Section 2, who is the head of the laboratory

FALSE, they must be duly qualified in laboratory medicine

ANY licensed physician can be the head of the laboratory (TRUE/FALSE)

Annually

Anyone who is authorized by the Secretary of Health is renewed ____?

No license

SECTION 2 (AUTHORITY):
___ ___ 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, direction, and supervision of an authorized physician.

authorized physician

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, direction and

supervision of an _____?

BUREAU OF HEALTH FACILITIES AND SERVICES

BHFS means..?

DOH

______ under the BHFS in the Health Regulation Cluster shall exercise the regulatory functions under the rules and regulations

PURPOSE

What is section 3 of RA 4688?

Secretary of health through BRL

• shall be charged with the responsibility of strictly enforcing the provisions of this Act

• shall be authorized to issue such rules and regulations as may be necessary to carry out its provisions.

provisions

Secretary of health through BRL shall be charged with the responsibility of strictly enforcing the ____ of RA 4688

rules and regulations

Secretary of health through BRL shall be authorized to issue such ___ and ___ as may be necessary to carry out its provisions.

SCOPE

What is section 4 of RA 4688?

Punishments in cases of violations against RA 4688

a) imprisonment for not less than 1 month but not more than 1 year, or;

b) fine of not less than P1000 nor more than P5000, or;

c) both fine and imprisonment, at the discretion of the court.

Not less than 1 month but not more than 1 year

Punishments in cases of violations against RA 4688 includes imprisonment for not less than _____ but not more than ____

Not less than 1000 pesos nor more than 5000 pesos

Punishments in cases of violations against RA 4688 includes a fine of not less than ____ nor more than ____

court

Punishments in cases of violations against RA 4688 includes both the fine and imprisonment, at the discretion of the ____

POLICIES

What is section 6 of RA 4688?

50,000 pesos or so

authorized to be appropriated, out of any funds in the National Treasury not otherwise appropriated, to carry into effect the provisions of this Act. (ACCORDING TO SECTION 6)

National Treasury

50,000 pesos or so authorized to be appropriated, out of any funds in the ___ ___ not otherwise appropriated, to carry into effect the provisions of this Act. (ACCORDING TO SECTION 6)

CLASSIFICATION OF LABORATORIES

What is section 5 of RA 4688?

ANATOMIC PATHOLOGY, CLINICAL PATHOLOGY

Classification of Laboratories by FUNCTION

HOSPITAL-BASED,
NON-HOSPITAL-BASED

Classification of Laboratories by INSTITUTIONAL CHARACTER

PRIMARY,
SECONDARY,
TERTIARY

Classification of Laboratories by SERVICE CAPABILITY

SURGICAL PATHOLOGY,
IMMUNOHISTOPATHOLOGY,
CYTOLOGY,
AUTOPSY,
FORENSIC PATHOLOGY

What tests do an Anatomic Pathology Laboratory perform?

HOSPITAL-BASED LABORATORY

Laboratory that operates within a hospital

NON-HOSPITAL-BASED LABORATORY

A laboratory that operates on its own

FREE-STANDING LABORATORY

Non-hospital-based laboratory is also known as:

GOVERNMENT,
PRIVATE

Hospital-based laboratories are further divided into two divisions:

A primary laboratory performs minimum services such as

• ROUTINE HEMATOLOGY (CBC),

• ROUTINE CLINICAL MICROSCOPY PROCEDURES (urinalysis and fecalysis),

• BLOOD TYPING

• QUANTITATIVE PLATELET DETERMINATION

Routine hematology (CBC), routine urinalysis, routine fecalysis, blood typing, quantitative platelet determination

A primary laboratory performs minimum services such as

10 sq. m.

Required space for primary laboratories

Equipment and instruments in the primary laboratory

• Clinical centrifuge

• Hemacytometer

• Microhematocrit centrifuge

• Microscope

• Hemoglobinometer

• Differential blood cell counter

ROUTINE CLINICAL CHEMISTRY and CROSS MATCHING

A secondary laboratory provides minimum services of a PRIMARY LAB and the following:

Blood Glucose, Blood Urea Nitrogen (BUN), Blood Uric Acid (BUA), Blood Creatinine, Total Cholesterol

ROUTINE CLINICAL CHEMISTRY Tests conducted in secondary laboratories

20 sq. m.

Required space for secondary laboratories

Equipment and instruments in the secondary laboratory

• Primary

• Refrigerator

• Photometer

• Water bath

• Timer

SPECIAL CLINICAL CHEMISTRY,
SPECIAL HEMATOLOGY,
IMMUNOLOGY AND SEROLOGY,
MICROBIOLOGY

A tertiary laboratory provides minimum services of a SECONDARY LAB and the following:

60 sq. m with separate room for Microbiology

Required space for tertiary laboratories

Equipment and instruments in the tertiary laboratory

• Primary

• secondary

• incubator

• balance, trip/analytical

• serofuge

• autoclave

• drying oven

• biosafety cabinet

AO NO. 274 SERIES OF 1976

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

must be licensed

Responsibilities of the Department of Health and Laboratories:

1. _____ as specified in RA 4688

Position of medical technologist

Responsibilities of the Department of Health and Laboratories:

2. ____ of ____ should be provided for each of the sections of clinical chemistry, clinical microscopy (urinalysis and parasitology), microbiology (bacteriology), hematology, blood banking and serology and histopathology

Adequate laboratory space

The Responsibilities of the Department of Health and Laboratories includes?

3. having adequate ___ ____

sufficient equipment and supplies

The Responsibilities of the Department of Health and Laboratories includes?

4. Sufficient ___ and ____

2 interns

The Responsibilities of the Department of Health and Laboratories includes?

5. _____ at any time in each section

training program for medical technology interns

The Responsibilities of the Department of Health and Laboratories includes?

6. Must have a _____ for ______.

Additional requirements for the training program of medical technology interns

• must be a member of the specialty society in laboratory medicine

• training program should be prepare in coordination with the training officer and must be submitted to the Committee on Affiliation with the contract of affiliation

• Objective measure or evaluation of the baseline skills and knowledge prior to allowing interns to handle actual specimens

specialty society in laboratory medicine

You must be a member of the ____ ____ in ___ ___ in order to have a training program for MT interns and become affiliated

training officer; Committee on Affiliation

Training program should be prepared in coordination with the ____ ____ and must be submitted to the ____ __ ____ with the contract of affiliation

contract of affiliation

Training program should be prepared in coordination with the training officer and must be submitted to the Committee on Affiliation with the ___ of _____.

baseline skills and knowledge

Additional requirements for the training program of MT interns:

Objective measure or evaluation of the ___ ___ and ___ prior to allowing interns to handle actual specimens

The training program for MT interns must include

• Objective of training

• Procedures and methods to be taught

• Principles of the methods

• Right work attitudes and ethical values

• Required quota to develop accuracy and precision

• Objective evaluation of performance in each section

• Time schedule

• Lectures, seminars and conferences

• Methodology of training

FALSE

The training program for MT interns does not strictly need to contain the Time schedule (TRUE/FALSE)

TRUE

The training program for MT interns must contain the Objective evaluation of performance in each section (TRUE/FALSE)

Objective of training, principles of methods, time schedule, methodology of training, right work attitudes and ethical values

Give 5 required contents for the training program of MT interns

FALSE, minimum number

A responsibility of the Department of Health and Laboratories includes the maximum number of examinations or samples of each section to accommodate interns (per annum) [TRUE/FALSE]

3,000 Exams

Clinical chemistry has a minimum number of? (AO no. 274 s. 1976)

Urinalysis, parasitology

Tests under Clinical Microscopy includes

1,500 samples

Clinical microscopy - Complete Urinalysis has a minimum number of?

(AO no. 274 s. 1976)

1,500 samples

Clinical microscopy - Parasitology has a minimum number of?

direct fecal smear and concentration test or Kato thick smear

Examples of tests under Parasitology (Clinical Microscopy section)

Kato thick smear

Concentration test under Parasitology is aka?

Gram staining, acid test, and isolation and identification of organisms

tests under the microbiology section

800 samples

Microbiology - Gram staining & acid staining has a minimum number of?

1000 samples

Microbiology - Isolation and identification of organisms has a minimum number of?

Peripheral blood study, sedimentation rate, platelet count, bleeding and clotting time, malarial smears, and other tests

Tests under the Hematology section

hemoglobin, white cell count, Schilling, hematocrit and red cell morphology or CBC

Examples of Peripheral blood study under the Hematology section

1,200 samples

The Peripheral blood study under the Hematology section has a minimum

800 samples

Sedimentation rate, platelet count, bleeding and clotting time, malarial smears and other tests under the Hematology section has a minimum of?

blood typing, complete cross-matching, serology (VDRL and Widal Test)

Tests under the Blood Banking and Serology section

900 tests

blood typing under the Blood Banking and Serology section has a minimum of?

600 tests

Complete cross matching under the Blood Banking and Serology section has a minimum of?

venereal disease research laboratory (VDRL) test, Widal test

types of serology tests under the Blood banking and serology

300 tests

Serology - Widal Test under the Blood Banking and Serology section has a minimum of?

300 tests

Serology - Venereal Disease Research Laboratory (VRDL) test under the Blood Banking and Serology section has a minimum of?

500 tests

Histopathology & Cytology has a minimum of?

2 interns

Histopathology & Cytology has a minimum of how many interns?

intern; half

For each additional ____, another ___ of the requirement shall be added

at least 1 member

Responsibilities of the Department of Health and Laboratories:

8. At least ____ member of the professional staff to every group of interns not exceeding 10 in each section should be provided

not exceeding 10 in each section

At least 1 member of the professional staff to every group of interns not exceeding ___ in each section should be provided.

attendance, behavior, and performance

Responsibilities of the Department of Health and Laboratories

9. Staff and personnel of the laboratory must be assisted by a laboratory instructor to monitor ___ ___ ___ including guidance in readings and application to the theoretical knowledge

10 medical technology interns

Responsibilities of the Department of Health and Laboratories

10. No more than ___________________________ shall be allowed to train during the night shift in understaffed hospitals. No intern is to be assigned without the regular professional staff on duty at all times.

Intern’s affiliation fee; laboratory needs

Responsibilities of the Department of Health and Laboratories

11. ______________ for the laboratory must be spent for __________________ utilized exclusively for training and not for payment of furniture or appliances.

Director of the hospital

Responsibilities of the Department of Health and Laboratories

12. ______________________ is responsible for the admission of the number of interns approved by the Committee.

area or region

Responsibilities of the Department of Health and Laboratories

13. Priority is given to interns residing within the ___ or ___ of the hospital.

affiliation fees and budgetary outlay

Responsibilities of the Department of Health and Laboratories

Quarterly reports on the ________________ and ________________ showing the proposed amount for each personnel must be submitted to the Secretary of Health thru the Accreditation Committee together with the report of the status/or problems of the Affiliation Program

Secretary of Health

Responsibilities of the Department of Health and Laboratories

Quarterly reports on the affiliation fees and budgetary outlay showing the proposed amount for each personnel must be submitted to the _____ thru the Accreditation Committee together with the report of the status/or problems of the Affiliation Program

Requirements before applying for affiliation of Universities/Schools/Colleges of Medical Technology?

1. Approval from DepEd and the Board of Medical Technology

2. Compliance with the provisions of RA 5527 and PD 498

DepEd and the Board of Medical Technology

One of the Requirements before applying for affiliation of Universities/Schools/Colleges of Medical Technology is the approval from ___ and ____ ?

RA 5527 and PD 498

One of the Requirements before applying for affiliation of Universities/Schools/Colleges of Medical Technology is the Compliance with the provisions of ___ and ___

Universities, schools and colleges shall

1. Provide a laboratory instructor

2. Pay or replace damage, breakage of losses by the medical technology interns of laboratory property, equipment or supplies

3. Make sure that all interns before the start of internship must have completed the theoretical aspect

4. Pay the hospital the amount of P35 for each intern monthly.

5. Make a request of affiliation (6 copies) to the Chief of Hospital and must be renewed every school year

6. See to it that laboratory instructor and students observe and abide rules and regulations

7. See to it that students and instructor are in proper uniforms and provided with a laboratory gown.