PMTP Finals

An essential component of health institutions that provides accurate and reliable information to medical doctors for the diagnosis, prognosis, treatment, and management of diseases.

Clinical Library

Focuses on areas such as clinical chemistry, immunohematology, blood banking, medical microbiology, immunology and serology, hematology, clinical microscopy, and others. It is concerned with the diagnosis and treatment of diseases performed through laboratory testing of blood and other body fluids.

Clinical Pathology

Focuses on areas such as histopathology, immunohistopathology, cytology, autopsy, and forensic pathology. It is concerned with the diagnosis of diseases through microscopic examination of tissues and organs.

Anatomic Pathology

clinical laboratory within the premises of an institution

Institutional - based

a clinical laboratory that is not part of an institution

Free standing

Clinical laboratories that are owned wholly or partially by the national or local government.

Government-owned

Clinical laboratories owned, etablished, and operated by an individual corporation, institution, association, or organization

Privately - owned

Routine hematology, urinalysis, fecalysis, and Gram staining.

Primary Category

Services in the primary category + routine chemistry, blood typing, ad cross matching

Secondary category

primary & secondary + donor selection & blood collection, special chemistry, and special hematology procedures.

Tertiary Category

government hospital designated by the DOH to provide certain special diagnostic functions and services for certain diseases.

National Reference Category

“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.

Republic Act 4688

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: 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 1

• 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 laboratory medicine and authorized by the Secretary of Health, such authorization to be renewed annually. 

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 authorized physician, as provided for in the preceding paragraph.

SECTION 2

 Any person, firm, or corporation who violates any provisions 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 by a fine of not less than one thousand pesos nor more than five thousand pesos, or both such fine and imprisonment, at the discretion of the court.

SECTION 4

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

SECTION 5

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

SECTION 6

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

SECTION 7

This Act shall take effect upon its approval

SECTION 8

•  “Rules and Regulations Governing the Establishment, Operation and Maintenance of Clinical Laboratories in the Philippines”

Administrative Order No. 59 s. 2001

This Administrative Order shall be known as the “Rules and Regulations Governing the Establishment, Operation, and Maintenance of Clinical Laboratories in the Philippines.”

Section 1: Title

These rules and regulations are issued to implement R.A. 4688: Clinical Laboratory Law consistent with E.O. 102 series 1999: Redirecting the Functions and Operations of the Department of Health. The Department of Health (DOH), through the Bureau of Health Facilities and Services (BHFS) in the Health Regulation Cluster, shall exercise the regulatory functions under these rules and regulations.

Section 2: Authority

These rules and regulations are promulgated to protect and promote the health of the people by ensuring the availability of clinical laboratories that are properly managed with adequate resources, with effective and efficient performance through compliance with quality standards.

Section 3: Purpose

These regulations shall apply to all entities performing the activities and functions of clinical laboratories which shall include the examination and analysis of any or all samples of human and other related tissues, fluids, secretions, radioactive, or other materials from the human body for the determination of the existence of pathogenic organisms, pathologic processes, or conditions in the person from whom such samples are obtained.

These regulations do not include government laboratories doing laboratory examinations limited to acid-fast bacilli microscopy, malaria screening, and cervical cancer screening, provided their services are declared as an extension of a licensed government clinical laboratory.

• Section 4: Scope

Classification of Laboratories

Section 5

Hematology, Clinical Chemistry, Microbiology, Parasitology, Mycology, Clinical Microscopy, Immunology and Serology, Immunohematology, Toxicology and Therapeutic Drug Monitoring, and other similar disciplines.

Clinical Pathology

 Surgical Pathology, Immunihistopathology, Cytology, Autopsy, and Forensic Pathology

Anatomic Pathology

lab that operates within a hospital

Hospital-based-laboratory

lab that operates on its own.

Nonhospital-based laboratory

Primary -

1. Routine Hematology (Complete Blood Count or CBC) – includes Hemoglobin Mass Concentration, Erythrocyte Volume Fraction (Hematocrit), Leucocyte Number Concentration (WBC count), and Leucocyte Type Number Fraction (Differential Count), Qualitative Platelet Determination 

2. Routine Urinalysis 

3. Routine Fecalysis 

4. Blood typing – hospital-based 

5.  Quantitative platelet determination – hospital-based

services in primary category plus:

1. Routine Clinical Chemistry – includes Blood Glucose Substance Concentration, Blood Urea Nitrogen Concentration, Blood Uric Acid Substance Concentration, Blood Creatinine Concentration, Blood Total Cholesterol Concentration 

2. Cross-matching 

Secondary

provides the secondary service capabilities plus 

1.  Special Chemistry

2. Special Hematology

3. Immunology/Serology

4. Microbiology

Tertiary

1. An approved permit to construct and design the layout of a clinical laboratory shall be secured from the BHFS prior to submission of an application for a Petition to Operate. 

2. No clinical laboratory shall be constructed unless plans have been approved and a construction permit issued by the BHFS. 

3. A clinical laboratory shall operate with a valid license issued by BHFS/CHD, based on compliance with the minimum licensing requirements (Annex A). 

4. The clinical laboratory shall be organized and managed to provide effective and efficient laboratory services. 

5. The clinical laboratory shall provide adequate and appropriate safety practices for its personnel and clientele.

Section 6: Policies

1. Application for Permit to Construct

2. Application for a new license

3. Application for renewal of license

Section 7: Requirements and Procedures for Application of Permit to Construct and License to Operate

1. The following are the documents required: a. Letter of Application to the Director of BHFS b. Four (4) sets of Sited Developmental Plans and Floor Plans approved by an architect and/or Engineer. c. DTI/SEC Registration (for private clinical laboratory) . 

Application for Permit to Construct

A duly notarized application form “Petition to Establish, Operate and Maintain a Clinical Laboratory”, shall be filed by the owner or his duly authorized representative at the BHFS.

Application for a new license

A duly notarized application form “Application for Renewal of License to Establish, Operate and Maintain a Clinical Laboratory” shall be filed by the owner or his duly authorized representative at the respective CHD.

Application for renewal of license

Renewal of License:

Application for renewal of the license shall be filed within 90 days before the expiry date of the license described as follows:

NCR - Jan to March

1, 2, 3, & CAR - Feb to April

4, 5, & 6 - March to May

7, 8, & 9 - April to June

10, 11, 12, CARAGA & ARMM - May to July

Valid license issued by BHFS/CHD based on compliance with minimum licensing requirements.

License to Operate

Adequate and appropriate safety practices for personnel and clientele in the clinical laboratory.

Safety Practices

A notarized form filed by the owner or authorized representative to renew the license of a clinical laboratory.

Application for renewal of license

The process of renewing the license to operate a clinical laboratory, which must be done within 90 days before the expiry date of the license.

Renewal of License

Non-refundable fees charged for the application for a permit to construct, a license to operate a government and private clinical laboratory, and for the application for renewal of license to operate.

Permit and License Fees

Fines imposed for late renewal of license, with an additional penalty for applications received more than two months after the expiry date.

Penalties

The process of examining the premises, facilities, and records of a clinical laboratory by the Director of the BHFS/CHD or their authorized representative(s).

Inspection

Regular monitoring of clinical laboratories to ensure compliance with rules and regulations, with records made available for review by the Director of the BHFS/CHD or their authorized representative(s).

Monitoring

The granting of a license to operate a clinical laboratory by the Director of the CHD or their authorized representative, if the application is found to be meritorious.

Issuance of License

The conditions and requirements that must be met by the owner or authorized representative of a clinical laboratory to maintain the license, including reporting any changes and placing the license in a conspicuous location within the laboratory.

Terms and conditions of License

Actions or omissions that are considered violations of the rules and regulations for operating a clinical laboratory, including operating without a certified pathologist or registered medical technologist, refusing inspection, and gross negligence.

SECTION 8: Violations

 authorized to report to the CHD and BHFS the existence of unlicensed clinical laboratories or any private party performing laboratory examinations without proper license and/or violations of these rules and regulations.

The Provincial, City, and Municipal Health Officers

The process of investigating complaints or charges against a clinical laboratory or its personnel to determine if violations have occurred.

Investigation of Charges or Complaints

The authority to modify, suspend, or revoke a license for false statements, violations, or failure to comply with the terms and conditions of the license.

Modification and Revocation of License

These rules and regulations shall supersede all other previous official issuances hereof.

• Section 11: Repealing Clause

A list of licensed clinical laboratories shall be published annually in a newspaper of green circulation

• Section 12: Publication and List of Licensed Clinical Laboratories

These rules and regulations shall take effect 15 days after its publication in the Official Gazette, or in a newspaper of general circulation

• Section 13: Effectivity

what are the Technical Standards and Minimum Requirements?

1. STAFFING

2. PHYSICAL FACILITIES

3. EQUIPMENT/ INSTRUMENT

4. GLASSWARES/ REAGENT/ SUPPLIES

5.  WASTE MANAGEMENT

6. QUALITY CONTROL PROGRAM

   6.1. Internal Quality Control Program

   6.2. EXTERNAL QUALITY CONTROL PROGRAM

7. REPORTING

8. RECORDING

9. LABORATORY FEES

The annual publication of a list of licensed clinical laboratories in a newspaper of general circulation.

Publication and List of Licensed Clinical Laboratories

Standards and requirements for staffing, physical facilities, equipment/instruments, glassware/reagents/supplies, and waste management in clinical laboratories.

Technical Standards and Minimum Requirements

A program implemented in clinical laboratories to ensure the accuracy and reliability of test results.

Quality Control Program

A component of the quality control program that includes continuous competency assessment, standard laboratory methods, maintenance of equipment, and use of quality control reference materials.

Internal Quality Control Program

A component of the quality control program that involves participation in an external quality assurance program provided by designated national reference laboratories or recognized reference laboratories.

External Quality Control Program

The process of releasing laboratory results to the requesting physician, which includes the inclusion of the names of registered medical technologists and the pathologist on laboratory reports.

Reporting

The system of accurately documenting and storing requests and reports of all specimens submitted and examined in the laboratory.

Recording

The charges for laboratory examinations, which should be within the prevailing rates and consider the cost of testing and quality control.

Laboratory Fees

Assemblies of professionals within a specific specialization or professional field that provide opportunities for professional growth, networking, education, and recognition.

Benefits of membership Professional Organizations

An organization that accredits curricular programs in educational institutions.

Accrediting Organization

An organization that provides certification examinations for professionalism.

Credentialing/Certifying Organization

Organizations that contribute to the development of a specific group of professionals.

Professional Societies

Publications containing scholarly studies on specific professional fields, usually prepared by professionals in the field and peer-reviewed by experts.

Professional Journals

The Philippine Association of Medical Technologists, the national professional organization for Medical Technology in the Philippines.

PAMET

It is a non-stock, non-profit organization

PAMET

Organized its first national convention and election of officers on September 20, 1964, at the Far Eastern University

PAMET

It was founded on September 15, 1963, through Crisanto G. Almario “Father of PAMET” at the Public Health Laboratory

PAMET

symbolizes the continuous involvement where practice and education must always be integrated in PAMET insignia.

CIRCLE

the trilogy of love, respect, and integrity.

TRIANGLE

symbolize the science of the Medical Technology profession.

Microscope & Snake

the color of health

GREEN

the year of the first PAMET election

1964

Symbols representing the continuous involvement, love, respect, integrity, and the science of the Medical Technology profession in PAMET.

PAMET Insignias

He succeeded in working for the bill (House Bill No. 7682) for the Medical Technologists in the country through the help of Congressman Jose Moreno and Congresswoman Magnolia Antonio.

• Charlemagne Tamondong (1963-1967)

He worked for the building and recognition of PAMET for public acceptance and good social standing.

• Charlemagne Tamondong (1963-1967)

He worked for the passage of Senate Bill No. 996. He signed into law the President of the Philippines, His Excellency, President Ferdinand E. Marcos into Republic Act No.005527 or the Medical Technology Act of 1969, on June 21, 1969.

• Nardito D. Moraleta (1967-1970)

• He worked for the registration of PAMET with the Securities and Exchange Commission Octoberober 14, 1969 (Registration No. 395 70). 

• Nardito D. Moraleta (1967-1970)

• He worked for the registration of PAMET and its membership to the International Association of Medicalical Laboratory Technologists (IAMLT in Europe) on May 28, 1970.

• Nardito D. Moraleta (1967-1970)

• He worked for the amendments and approval of the   PAMET   Constitution and   By-Laws approved at the 1969 National Convention of PAMET at UST.

• Nardito D. Moraleta (1967-1970)

• He worked for the Standardization of the Medical Technology Curriculum in all Schools of Medical Technology in the Philippines through the Medical Technology Council in 1970.

• Nardito D. Moraleta (1967-1970)

He worked for the publication of the first official newspaper of the association—the “PAMETNews”

• Nardito D. Moraleta (1967-1970)

He worked for the approval of Presidential Decree No. 498 which was signed by His Excellency, President Ferdinand E. Marcos on June 28, 1974. This is an amendment to R.a No. 00527.

• Felix Asprer (1970-1971 & 1973-1977)

• He had the Philippines  Association of   Medical Technologists Integrated   (accredited as a bonafide professional organization for Medical Technologists) with the Professional Regulation Commission on May 24, 1975.

• Felix Asprer (1970-1971 & 1973-1977)

• He worked for the amendments to the Teves Law (about salaries of medical professionals) which was in the third reading in the Senate when Martial Law was proclaimed, so the said project died

• Bernardo T. Tabaosares (1971-1973)

• One of his pet projects was approved by His Excellency, President Ferdinand Marcos through the help of the Presidential Assistant, Guillermo de Vega proclaiming the third week of September as the MedTech Week. 

• Bernardo T. Tabaosares (1971-1973)

• Worked for the approval of the Profession Tax through the BIR - that all registered medical technologists should pay a professional tax in the amount of seventy-five pesos yearly.

• Angelina R. Jose (Jan. 1973-Sept. 1973)

• Saw to it that monthly medical missions were made as part of the association’s services to the poor and unfortunate people in our country.

• Venerable C.V. Oca (1977-1982)

• A series of seminars are being conducted monthly;y with different prominent speakers to update the profession and the medical technologists who were in the active practice of their profession.

• Venerable C.V. Oca (1977-1982)

Introduced PAMET to different companies and well-known organizations both local and international (mostly at her financial expense) which gained PAMET recognition from these companies and organizations.

• Carmencita P. Arcadera (1982-1992)

• Worked for the membership of PAMET with the ASEAN Association of Medical Laboratory Technologists (AAMLT).

• Carmencita P. Arcadera (1982-1992)

• Worked for the publication of the official newspaper of the association “Lab News” and the official journal of the association “Phil. Journal of Medical Technology”.

• Marilyn R. Atienza (1993-1996)

• She worked for the membership of PAMET to the ASEAN Association of Southeast Asia Medical Laboratory Science (AAMLS).

• Marilyn R. Atienza (1993-1996)

• Worked on the revision of the MedTech Code of Ethics on March 7, 1997.

• Norma Nunez Chang (1997-2000)

• Worked for the amendments of R.A 00557 at the Congress of the Philippines. 

• Maintained a close link with other professional associations by being an active member of the Council of Health Agencies of the Philippines (CHAP), the Council of Professional Health Association (COPHA), and the Philippine Foundation of Professional Associations (PFPA).

• Worked for the welfare and protection of medical technologists by continuing professional education, community services, and global competitiveness.

• Worked for the approval of the 2002 PAMET Constitution and By-Laws

• Worked for the job fair activity for the newly registered medical technologists.

• Agnes B. Medenilla (2001-2002; 2005-2006)