MedTech Laws

• AO No. 2007-027 • AO No. 49-B Series of 1988

Administrative Orders under RA 4688

4 clinical laboratories

A certified pathologist is authorized to manage/supervise or be an associate in notmore than _____

Accredited Medical Technology Training Laboratory

A clinical laboratory, office, agency, clinic, hospital sanitarium duly approved by the Department of Health or its authorized agency.

Pathologist

A duly registered physician who is specially trained in methods of laboratory medicine, of the gross and microscopic study and interpretation of tissues, secretions and excretions of the human body and its functions in order to diagnose disease, follows its course, determine the effectivity of treatment, ascertain cause of death and advance medicine by means of research.

National Reference Laboratory

A laboratory in a government hospital which had been designated by the DOH to provide special functions and services for specific disease areas: • Provision of referral services such as confimatory testing, surveillance, resolution of conflicting results , training, research, EQAS, evaluation of diagnostic kits and reagents

Medical Technologist

A person who engages in the work of medical technology under the supervision of a pathologist or licensed physician authorized by the department of health in places where there is no pathologist and who having passed a prescribed course (Bachelor of Science in Medical Technology/Bachelor of Science in Hygiene) of training and examination is registered under the provision of this Act.

Medical Technician

A person who not being a graduate of Bachelor of Science in Medical Technology/Bachelor of Science in Hygiene, but having passed the corresponding civil service examination, performs the work of medical technology under the supervision of a registered medical technologist and/or qualified pathologist.

only one hospital laboratory

A physicial may be authorized to head _____________

Scope and Coverage - This AO applies to all entities performing the activities and functions of clinical laboratories - Excludes government laboratories doing laboratory examinations limited to: • AFB microscopy • Malarial screening • Cervical cancer screening

AO No 2007-027 Section III

Revised Rules and Regulations Governing the Licensure and Regulation Regarding the Clinical Laboratories of the Philippines

AO No. 2007-027 is otherwise known as:

Revised Rules and Regulations Governing the Registration, Operation and Maintenance of Clinical Laboratories in the Philippines

AO No. 49-B Series of 1988 is otherwise known as:

requesting physician and pathologist

All laboratory request shall be considered as consultations between:

1 year

All laboratory requests and reports shall be kept on file for at least ________

• RA 6138 • PD 498 • PD 1534

Amendments made on RA 5527

Recognized School of Medical Technology"

Any school, college or university which offers a course in Medical Technology approved by the Department of Education in accordance with the requirements under this Act, upon recommendation of the council of medical technology education.

June 21, 1969

Approval date of RA 5527

• Clinical Pathology • Anatomic Pathology

Classification by Function

• Institution-based • Free-standing

Classification by Institutional Character

• Government • Private

Classification by Ownership

• General Clinical Laboratory • Special Clinical Laboratory

Classification by Service Capability

June 21, 1969

Date RA 5527 was made into law/ Approval date

• Molecular Pathology • Immunohistopathology • Cytology • Surgical Pathology • Autopsy • Forensic Pathology

Disciplines under Anatomic Pathology

• Clinical Chemistry • Hematology • Immunohematology • Microbiology • Immunology • Clinical Microscopy • Endocrinology • Molecular Biology • Cytogenetics • Toxicology • Therapeutic Drug Monitoring

Disciplines under Clinical Pathology

September 20, 1964

First PAMET National Convention

• Primary • Secondar • Tertiary • Limited Service Capability (institution-based)

General Clinical Laboratory

• LTO is issued in name of licensee and non-transferable • It is valid for 1 year • LTO of non-hospital based must stipulate: • Name of CLinical Laboratory • Name/s of the owner or operator • Head of the Laboratory • Service Capability • Period of Validity • License number • Location wherein the laboratory procedures are to be performed • must be displayed at all times at a prominent place • Hospital-based is not required to obtain a separate license (licensed through One-Stop-Shop Licensure for Hospitals) • Clinical Labs and satellite services within same compound have 1 LTO; separate compound requires separate LTO • Mobile Labs are licensed as part of main clinical laboratory; collect specimens only; only allowed to operate within 100 km radius from main lab • Changes shall be reported to CHD within 2 weeks from initial date of implementation; failure to report leads to suspension/revocation

Guidelines for LTO

• Laboratories for Academic and Research Purposes • Laboratories within clinics

LTO Exemptions

conspicuous place within the laboratory

License of clinical laboratory must be placed in ____________

emergencies

NO person in the clinical laboratory shall issue a report without directive from the pathologist except during:

32

No. of sections of RA 5527

• June 11, 1978 • Sections: 3,8,13

PD 1534

• June 28, 1974 • Sections: 2,3,4,7,8,11,13,16,17,21,29

PD 498

• Bedside testing • Outpatient Care • Home care

POCT includes:

Critical Values

Panic values orginallydescribed by Lundberg as " life-threatening" unless something is done promptly and for which some corrective action could be undertaken

• Imprisonment of not less than 1 month • Fine not less than 5000 pesos • Managing head/ Owner shall be liable

Penalty in RA 4688

• Routine hematology (CBC: Hb, Hct, WBC and Diff count) • Qualitative Platelet Determination • Routine Urinalysis • Routine Fecalysis • Blood Typing

Primary Laboratory Services

Blood Bank Law of 1956

RA 1517 is otherwise known as:

June 16, 1956

RA 1517 was approved on:

Clinical Laboratory Act of 1966

RA 4688 is otherwise known as:

June 18, 1966

RA 4688 was approved on:

Philippine Medical Technology Act of 1969

RA 5527

• August 31, 1970 • Sections: 16, 21, 22

RA 6138

1:2

Ratio of medical technologist to medical technicians

permanently

Records of anatomic and forensic pathology should be kept _____________

• LTO is renewed 90 days prior to actual expiration date • Discount: first day of October until last day of November • Late renewal: Find of 1000 (first 2 months) Plus 100.00 for each month

Renewal Guidelines of LTO

sta'tim - immediately

STAT is abbreviation for:

• Routine CC (Blood glucose, BUN, BUA, Crea, Total Cholesterol) • Quantitative Platelet determination • Cross matching • Gram staining • KOH

Secondary Laboratory Services

Title

Section 1

Compensation of the Members of the Board of Examiners for Medical Technology • 10 pesos - each applicant examined • 5 pesos - each applicant granted a COR without examination

Section 10

Functions and Duties of the Board (a) Administer the provisions of this Act; (b) Administer oaths (c) Issue, suspend and revoke certificates (d) Look into conditions affecting the practice of medical technology in the Philippines (e) Investigate such violations of this Act (f) Draft such rules and regulations

Section 11

Removal of Board Members 1. Neglect of duty 2. Incompetency 3. Malpractice 4. Unprofessional, unethical, immoral or dishonorable conduct * President has power to remove or suspend such member and appoint a temporary member in his place

Section 12

Accreditation of Schools of Medical Technology and of Training Laboratories • DepED - approve schools of MT • DOH through Bureau of Research and Laboratories or BHFS - approve training laboratories

Section 13

Inhibition Against the Practice of Medical Technology • Must have valid COR from passing MT Board exam • COR shall not be required: • Duly registered physician catering to own patients • Medtech from other countries called in for consultation as visitng or exchange professors to colleges or universities • Medtech in the service of United States Armed Forces stationed in the Philippines rendering service as such for members of the said forces only

Section 14

Examination • March and September • Written notice shall be published in at least 3 newspapers with national circulation at least 30 days prior to examination

Section 15

Qualification for Examination 1. In good health 2. Of good moral character 3. Completed 4 years of BSMT or BSPH 4. Non MT- practiced MT for 5 years before exam if performance began before June 21, 1969

Section 16

Scope of Coverage & Examination 20% • Clinical Chemistry • Microbiology and Parasitology • Hematology • Blood Banking and Serology 10% • Clinical Microscopy • Histopathologic Techniques, Cytotechnology, Medical Technology Laws and Ethics

Section 17

Report of Rating - Within 120 days after date of completion of examination - Submitted to Commissioner of Civil Service, who shall submit to President of Philippines for approval - 12 months refresher course - after third take

Section 18

Ratings in the Examination - General average of 75% - No rating below 50% in any major subject - No failure in at least 60% of the subjects computed according to their relative weights

Section 19

Definition of Terms

Section 2

Oath taking - All successful examinees shall take a professional oath before the Board or before any person authorized to administer oaths

Section 20

Issuance of Certificate of Registration - passed MT Board Exam - 21 years old - Fee of COR: 115 pesos; 3 years from birthday - Prior to June 21, 1969, MT without COR can practice: • Foreigner - 3 years • Non-MT - 8 years - Medical Technicians: • GWA: 70-74.9% • 10 years of being medical technicians • Fee of COR: 50 pesos - COR: signed by members of the board and Chairperson of PRC

Section 21

Fees • 50 pesos - each applicant for examination • 25 pesos - COR without prior examination • 10 pesos - issuance of new certificate to replace lost, destroyed, mutilated certificate

Section 22

Refusal to Issue Certificate • Convicted by court • Immoral or dishonorable conduct • Unsound mind • Incurable, communicable disease

Section 23

Administrative Investigation-Revocation or Suspension of Certificates • Conducted by at least 2 members of Board and 1 legal officer • Revocation - unanimous vote • Suspension - majority vote; must not exceed 2 years • Surrender COR within 30 days

Section 24

Appeal • Civil Service Commissioner - decision is final 30 days after promulgation unless appealed to President of the Philippines

Section 25

Reinstatement, Reissue or Replacement of Certificates

Section 26

Foreign Reciprocity - Foreigner shall be admitted to exam or given COR as long as his country permi•ts Filipino MTs to practice

Section 27

Roster of Medical Technologists • prepared annually by Secretary of Board: • Name • Address • Date of registration or issuance of COR • Removed from roster after 5 years • mailed to each person included • Filedin Office of the President and DOH

Section 28

Penal Provisions - not less than 2000 pesos not more than 5000 pesos - Imprisonment for not less than 6 months nor more than 2 years: (a) Any person who shall practice Medical Technology in the Philippines without being registered (b) without the necessary supervision of a qualified pathologist or physician authorized by the Department of Health; (c) Any medical technologist who shall knowingly made a fraudulent laboratory report; (d) Any duly registered medical technologist who shall refuse or fail, after due warning by the Board to display his certificate of registration in the place where he works; (e) Any person presenting or attempting to use as his own, the certificate of registration of another; (f) Any person who shall give any false or fraudulent device of any kind to the Board of any member thereof obtaining a certificate of registration as Medical Technologist; (g) Any person who shall impersonate any registrant of a fake or the same name; (h) Any person who shall attempt to use a revoked or suspended certificate of registration; (i) Any person who shall in connection with his name otherwise, assume, use or advertise any title or description tending to convey the impression that he is a Medical Technologist without holding a valid certificate of registration; (j) Any person who shall violate any provision of this Act; or (k) Any person or corporate body who shall violate the rules and regulations

Section 29

Council of Medical Technology Education, Its Composition • Chairman: Secretary of Education or Director of Private Education • Vice Chariman: Chairman of PRC • Members: 1. Board of Examiners 2. Rep. of PASMETH 3. Rep of PAMET 4. President of PSP 5. Dean of Institute of Hygiene in UP

Section 3

Separability Clause

Section 30

Repealing Clause

Section 31

Effectivity

Section 32

Compensation and Traveling Expenses of Council Members Chairman: 50 pesos per diem Members: 25 pesos

Section 4

Functions of the Council of Medical Technology Education (a) To recommend the minimum required curriculum for the course of medical technology. (b) To determine and prescribe the number of students (c) To approve medical technology schools (d) To require all medical technology schools to submit an annual report (e) To inspect, when necessary, the different medical technology schools (f) To certify for admission into an undergraduate internship students who have satisfactorily completed three years of the medical technology course or its equivalent and to collect from said students the amount of five pesos each which money accrue to the operating fund of the council. (g) Formulate and recommend approval of refresher course for applicants who shall have failed the Board Examination for the third time. (h) To promulgate and prescribe and enforce necessary rules and regulations for the proper implementation of the foregoing functions.

Section 5

Minimum Required Course • 4 years, 12 month internship • Subjects (Misc): • Spanish • General Zoolgy • Botany • Clinical Laboratory • Cytotechnology

Section 6

Medical Technology Board/ Board of Examiners Chairman: Pathologist; nominated by PSP Members: 2 Medical Technologists; nominated by PAMET • Appointed by President of the Philippines • Term - 3 years • In case of death, disability or removal of a member, his successor shall only serve the balance of his term

Section 7

Qualifications of Examiners 1. Filipino citizen 2. Of good moral character 3. Qualified pathologist 4. In the practice of laboratory medicine or medtech for at least 10 years ( Pathologist) 5. Not a member of the aculty of any MT school for at least 2 years * For the first 3 years following approval of this act, the requirements mentioned in 4 will be reduced to 8 years

Section 8

Executive Officer of the Board - Commissioner of Civil Service - Chairperson: Alicia dela-Rosa Bala * Secretary of the Board of Examiners shall keep a register of all persons to whom certificates of registration have been granted.

Section 9

Definition of Terms

Section IV

Classification of Clinical Laboratories A. By Ownership B. By Function C. By Institutional character D. By Service Capability

Section V

Guidelines

Section VI

• Section 3 - PD 498 and RA 1534 • Section 8 - PD 498 and RA 1534 • Section 13 - PD 498 and RA 1534 • Section 16 - PD 498 and RA 6138 • Section 21 - PD 498 and RA 6138

Sections that were amended twice

• Assisted Reproduction Technology • Molecular and Cellular Pathology • Molecular and Cellular Biology • Forensic Pathology • Anatomic Pathology

Special Clinical Laboratory services

• Special Chemistry • Special Hematology • Immunology/Serology • Microbiology (C/S)

Tertiary Laboratory Services

Board

The Board of Examiners for Medical Technology established under this Act.

Council

The council of medical technology education established under this Act.

Mobile Clinical Laboratory

a laboratory testing unit that moves from testing site to another testing site, or has a temporary testing location. It shall have a base laboratory

Special Clinical Laboratory

a laboratory that offers highly specialized laboratory services that are usually not provided by a general clinical laboratory

Satellite Testing Site

any testing site that performs laboratory examinations under the administrative control of a licensed laboratory, but performed outside the physical confines of that laboratory

Limited Service Capability

provides laboratory tests required for a particular service in institutions such as but not limited to dialysis centers and social hygiene clinics

STAT

tests done on urgent cases, the results of which shall be released immediately within 1 hour after the procedure

October 1, 1945

• Dr. Alfredo Pio de Roda organized the Public Heal Laboratory • Quiricada Street, Sta. Cruz, Manila

External Quality Assessment Program

• It is a program where participating laboratories are given unknown samples for analysis. • These samples are to be treated as ordinary human specimens for the usual processing and examination • The quality of performance of the laboratory shall be assessed through the closeness of its results to the pre-determined value or to the reference value generated by the participating laboratories through peer group analysis

June 22, 1973

• PD 223 • Profession Regulation Commission

July 21, 2016

• RA 10912 • Continuing Professional Development Act of 2016

June 16, 1956

• RA 1517 • Blood Bank Law of 1956

June 18, 1966

• RA 4688 • Clinical Laboratory Law of 1966

June 21, 1969

• RA 5527 • Philippine Medical Technology Act of 1969

January 23, 1972

• RA 6425 • Dangerous Drug Act of 1972

May 5, 1994

• RA 7719 • National Blood Services Act of 1994

February 13, 1998

• RA 8504 • Philippine AIDS Prevention and Control Act of 1998

December 5, 2000

• RA 8981 • PRC Modernization Act of 2000

January 23, 2002

• RA 9165 • Comprehensive Dangerous Drug Act of 2002

April 7, 2004

• RA 9288 • Newborn Screening Act of 2004