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

operation and maintenance of clinical laboratories, requiring the registration

An act regulating the _________ and_______ of the same with the Department of Health, providing penalty for the violation thereof, and for other purposes

Government hospital laboratories, extensions of government regional or central laboratories

_________ doing routine or minimum laboratory examinations shall be exempt from the provisions of this section if their services are _________

SECTION 1

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 pathologic 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

SECTION 2

Head of the laboratory:

-licensed physician duly qualified in laboratory medicine

-authorized by the Secretary of Health and to be renewed annually

licensed physician duly qualified in laboratory medicine

authorized by the Secretary of Health and to be renewed annually

Head of the laboratory:

No license; unless such laboratory is under the administration, direction and supervision of an authorized physician.

_______ shall be granted or renewed by the Secretary of Health for the operation and maintenance of a clinical laboratory ______

June 18, 1966

When was RA NO. 4688 approved?

Secretary of Health (through the Bureau of Research and Laboratories)

• 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

SECTION 3

• Secretary of Health (through the Bureau of Research and Laboratories):

• 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

SECTION 4

Punishments in cases of violations against the provisions of this Act:

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

2. fine of not less than P1000 nor more than P5000, or;

3. both fine and imprisonment, at the discretion of the court.

1 month, 1 year

Punishments in cases of violations against the provisions of this Act:

a.) imprisonment for not less than ____ but not more than _____ or;

P 1,000 ; P5,000

SECTION 4

Punishments in cases of violations against the provisions of this Act:

b.) fine of not less than _____ nor more than ______ , or;

fine and imprisonment

SECTION 4

Punishments in cases of violations against the provisions of this Act:

c.) both ______ and ______, at the discretion of the court.

P50,000

_____ 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. 

ADMINISTRATIVE ORDER 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

_________ as specified in R. A. 4688

Adequate laboratory space

Responsibilities of the Department of Health and Laboratories

1. Must be licensed as specified in R. A. 4688

2. Position of medical technologist 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

3. ____________

Sufficient equipment and supplies

Responsibilities of the Department of Health and Laboratories

4. _________________

2 interns at any time in each section

Responsibilities of the Department of Health and Laboratories

5.___________

Must have a training program for medical technology interns.

Responsibilities of the Department of Health and Laboratories

6.________________

Must be a member of the specialty society in laboratory medicine.

Responsibilities of the Department of Health and Laboratories

6. Must have a training program for medical technology interns.

a. _______________________________________________________

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

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

Committee on Affliation

Responsibilities of the Department of Health and Laboratories

6. Must have a training program for medical technology interns.

b. Training program should be prepared in coordination with the training officer and must be submitted to the ________________________ with the contract of affiliation

baseline skills, knowledge

Responsibilities of the Department of Health and Laboratories

6. Must have a training program for medical technology interns.

   c. Objective measure or evaluation of the ______________ and _____________ prior to allowing interns to handle actual specimens

Responsibilities of the Department of Health and Laboratories

6. Must have a training program for medical technology interns.

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

   d. Includes:

   1. _________________________________________

   2. _________________________________________

   3. _________________________________________

   4. _________________________________________

   5. _________________________________________

   6. _________________________________________

   7. _________________________________________

   8. _________________________________________

   9. _________________________________________

3,000

Responsibilities of the Department of Health and Laboratories:

7. Minimum number of examinations or samples of each section to accommodate interns (per annum):

1. Clinical Chemistry – ______________

1,500 samples

Responsibilities of the Department of Health and Laboratories:

7. Minimum number of examinations or samples of each section to accommodate interns (per annum):

   2. Clinical Microscopy

   1. Urinalysis (complete urinalysis) – ________________

   2. Parasitology (direct fecal smear and concentration test or Kato thick smear) – ______________

800 samples

1000 samples

Responsibilities of the Department of Health and Laboratories:

7. Minimum number of examinations or samples of each section to accommodate interns (per annum):

   3. Microbiology

   a. Gram staining, acid test staining – ________

   b. Isolation and identification of organisms – _________

1,200 samples

800 samples

Responsibilities of the Department of Health and Laboratories:

7. Minimum number of examinations or samples of each section to accommodate interns (per annum):

   4. Hematology

   a. Peripheral blood study (hemoglobin, white cell count, Schilling, hematocrit and red cell morphology or CBC) –_______

   b. Sedimentation rate, platelet count, bleeding and clotting time, malarial smears and other tests- ________

900 Tests

600 Tests

300 Tests

300 Tests

Responsibilities of the Department of Health and Laboratories:

7. Minimum number of examinations or samples of each section to accommodate interns (per annum):

   5. Blood Banking and Serology

   a. Blood typing - _____

   b. Complete cross-matching - _____

   c. Serology

   • VDRL ( Venereal Disease Research Laboratory Test) - _______

   • Widal Test - _______

500 test

Responsibilities of the Department of Health and Laboratories:

7. Minimum number of examinations or samples of each section to accommodate interns (per annum):

   6. Histopathology & Cytology = ________

another half

For each additional intern, _________ of the requirement shall be added

1 member

10

Responsibilities of the Department of Health and Laboratories:

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

monitor attendance

behavaior

performance

Responsibilities of the Department of Health and Laboratories:

9. Staff and personnel of the laboratory must be assisted by a laboratory instructor to __________________, ____________, _______________ including guidance in readings and application to the theoretical knowledge

10 medical technology interns

1:10

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.

interns

Responsibilities of the Department of Health and Laboratories:

13. Priority is given to _______ residing within the area or region of the hospital.

affiliation fees

budgetary outlay

Accreditation Committee

NOTE: Quarterly reports on the ________________ and ________________ 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.

Approval from DepEd and the Board of Medical Technology

Compliance with the provisions of RA 5527 and PD 498

1. Responsibilities of the Affiliating Universities/Schools/Colleges of Medical Technology

• Requirements before applying for affiliation:

1. _______________________________________________

2. _______________________________________________

1. Provide a laboratory instructor

• Universities, schools and colleges shall:

1. ____________________________

Pay or replace damage, breakage of losses

• Universities, schools and colleges shall

2. ______________________________________ by the medical technology interns of laboratory property, equipment or supplies

completed the theoretical aspect

• Universities, schools and colleges shall:

3. Make sure that all interns before the start of internship must __________________________________

P35

monthly

first five days of the month

• Universities, schools and colleges shall:

4. Pay the hospital amount of _________ for each intern ____________. Payment is done within the ___________________________

(6 copies)

renewed every school year

• Universities, schools and colleges shall

  5. Make a request of affiliation _________________ to the Chief of Hospital and must be ________________________

laboratory instructor

students

• Universities, schools and colleges shall

6.See to it that ________and ________ observe and avide rules and regulations

proper uniforms

laboratory gown.

• Universities, schools and colleges shall

7. See to it that students and instructor are in ________ and provided with a ________

Pathologist

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

_________:prepares the training program in coordination with the training officer

2 months

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

1. 12 months internship:

   1. Clinical Chemistry – __________

2 months

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

2. 12 months internship

b.) Clinical Microscopy (Urinalysis and Parasitology) – __________

2 months

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

2. 12 months internship

c. Microbiology (Bacteriology) – __________

2 months

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

2. 12 months internship

d. Hematology – __________

1 month

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

2. 12 months internship

e. Blood Banking and Serology – __________

1 month

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

2. 12 months internships

f. Histopathology – __________

8 weeks

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

2. 12 months internships

The remaining _______ will be assigned in any section

Evaluate

Changes

Problems

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

3. Monthly conference:

______ implementation of the program

_______ of the program

_______ of the implementation

Cooperation

harmonious working relations

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

4._______ and _______ among staff and interns

ADMINISTRATIVE ORDER NO. 118-B SERIES NO. OF 1992

Rules and Regulations Governing the Accreditation of Clinical Laboratories for Training of Medical Technology Interns

Name of establishment

◦Place, municipality and province

◦Name, citizenship, home address of the head

◦Name, citizenship, home address of the owner

◦Copy of a valid permit

◦Training program for medical technology interns

Basic Accreditation Requirements

1. _____________________________________

2. _____________________________________

3. _____________________________________

4. _____________________________________

5. _____________________________________

6. _____________________________________

7. Volume of examinations performed in the previous year for each section

P500.00

Accreditation Fees:

Initial application:_______

P250

Accreditation Fees:

Renewal: _______

P200.00

Accreditation Fees:

Penalty:____________ (filed within 90 days after expiration)

Director of Bureau of Research and Laboratories:

Inspection:

• ________________________________________: inspect the premises and facilities

Directors of Regional Health Offices, Provincial, City and Municipal Health Officers

Accreditation Fees:

• Each laboratory must prepare all the necessary records

• ________________________________________________________________: report to the BRL the existence of unaccredited clinical laboratories training medical technology interns

inform BRL in writing within 15 days after transfer

1. Terms and Conditions:

• Transfer location: __________________________________________________

suspension or revocation of certificate

1. Terms and Conditions:

• Penalty: _______________________________

2 years

• Expiration of Accreditation Certificate

________ after the date of approval (indicated at the upper right corne

60 days before expiration

1. Renewal:

• __________ before expiration

a)Training interns without a pathologist or medical technologist

b)False statement in the application

c)Failure to correct deficiencies within a reasonable time

d)Refusal to allow inspection

e)Repeated failure to submit an annual report

1. Violations:

1. ____________________________

2. ____________________________

3. ____________________________

4. ____________________________

5. ____________________________

Clinical Pathology

Classification of Laboratories

1. Classification by Function

1. ________________

Anatomic Pathology

Classification by Function

2. ____________

3. ◦ Surgical Pathology

4. ◦Immunohistopathology

5. ◦Cytology

6. ◦Autopsy

7. ◦ Forensic Pathology

Hospital-based laboratory

Non-hospital-based-laboratory

1. Classification by Institutional Character

1. ________________________: laboratory that operates within the hospital

2. ________________________: laboratory that operates at its own

Routine Hematology (CBC):

1.Hemoglobin

2.Hematocrit

3.WBC Count

4.Differential Count

5.Platelet Count (Qualitative)

• Routine Urinalysis

• Routine Fecalysis

• Blood Typing

• Quantitative platelet determination

Classification by Service Capability

• Primary Services

Primary

• Routine Clinical Chemistry

1. Blood Glucose

2. Blood Urea Nitrogen (BUN)

3. Blood Uric Acid

4. Blood Creatinine

5. Total Cholesterol

• Cross-matching

Classification by Service Capability

• Secondary Services

• Primary

• Secondary

• Special Chemistry

• Special Hematology

• Immunology/Serology

• Microbiology

Classification by Service Capability

• Tertiary Services

10 sq.m.

Classification by Service Capability

• Primary Space

20 sq. m.

Classification by Service Capability

• Secondary Space

60 sq. m. (to include a separate, enclosed and adequately ventilated room for Microbiology)

Classification by Service Capability

• Tertiary Space

• Clinical centrifuge

• Hemacytometer

• Microhematocrit centrifuge

• Microscope

• Hemoglobinometer

• Differential blood cell counter

Classification by Service Capability

• Primary Equipment/ Instruments

• Primary

• Refrigerator

• Photometer

• Water bath

• Timer

Classification by Service Capability

• Secondary Equipment / Instruments

• Primary

• Secondary

• Incubator

• Balance, trip/analytical

• Serofuge

• Autoclave

• Drying oven

• Biosafety cabinet

Classification by Service Capability

• Tertiary Equipment / Instruments

Letter of application

Requirements and Procedures for Application of Permit to Construct and License to Operate

• Application for permit to construct

1. ___________ to the Director of Bureau of Health Facilities and Services (BHFS)

4 sets of Site Development Plans and Floor Plans (approved by an architect or engineer)

Requirements and Procedures for Application of Permit to Construct and License to Operate

• Application for permit to construct

2. _____________________

DTI/SEC registration (for private laboratories)

Requirements and Procedures for Application of Permit to Construct and License to Operate

• Application for permit to construct

3. __________________________

Notarized application form

Application for new license

January to March

Application for renewal of license

• Region

  • NCR

• Schedule of application for renewal of license

  ________

February to April

Application for renewal of license

• Region

  • 1, 2, 3, CAR

• Schedule of application for renewal of license

  ________

March to May

Application for renewal of license

• Region

  • 4, 5, 6

• Schedule of application for renewal of license

  ________

April to June

Application for renewal of license

• Region

  • 7, 8, 9

• Schedule of application for renewal of license

  ________

Non-refundable

cashier of BHFS/ Centers for Health Development (CHD)

Requirements and Procedures for Application of Permit to Construct and License to Operate

1. Permit and license fees

• ________________________

• Must be paid to the ___________________________________________

P 1,000

Requirements and Procedures for Application of Permit to Construct and License to Operate

1. Penalties

• ________ for late renewal after 2 months from expiry date

Director of BHFS/CHD

Requirements and Procedures for Application of Permit to Construct and License to Operate

1. Inspection & Monitoring

• _____________________

Director of CHED

Requirements and Procedures for Application of Permit to Construct and License to Operate

1. Issuance of License

• _____________________

Nontransferable

Requirements and Procedures for Application of Permit to Construct and License to Operate

1. Terms and Conditions

• _____________________

• Extension laboratory has a separate license

• License must be displayed in a visible location or area of the laboratory

Refusal to allow inspection

Gross negligence

Any act or omission detrimental to the public

1. Violations

• Operation of laboratory without a pathologist or medical technologist

• Change of ownership, location head of laboratory or personnel without informing the BHFS and/or the CHD

• __________________________

• __________________________

• __________________________

Secretary of Health

Provincial, City and Municipal Health Officers

Requirements and Procedures for Application of Permit to Construct and License to Operate

NOTE:

1. ___________: may suspend or revoke the operation of laboratory

2. ___________: report the existence of unlicensed laboratories

Internal QC

External QC

1. ____________: provide appropriate and standard methods, reagents, etc.

2. ____________: given by a National Reference Laboratory

Quality Control

main purpose is to detect and repair performance – remove sporadic spikes – to the prior chronic level, either by prompt action to restore the status quo or, preferably, by preventing the damage from occurring in the first place

quality of reagents

Purposes/Objectives of QC:

1. to check for the ______________________

2. to check for the ______________________

3. to check for ______________________

Intralab QC (Internal QC)

Involves the analysis of control samples together with the patient specimen