Medtech Law
Medtech Law
JOHN SNOW Investigated the cholera 26th Medical Laboratory of 6th US Army:
outbreak in London. introduced MT practice in the Philippines
BEGINNING OF THE PRACTICE OF 208 Quiricada St., Sta. Cruz, Manila: 1st
MEDICAL TECHNOLOGY IN THE clinical laboratory; location of the present
PHILIPPINES (19TH CENTURY) Manila Public Health Laboratory
Army surgeons established the Philippine With Dr. Alfredo revived the training of
Tropical Disease Board to study the disease medical technicians to high school and
occurrence in the Philippines. paramedical graduates
1898 - epidemic typhoid fever occurred Training has no certificates and definite-
helps American scientists to further period
understand disease causation and developed
new approaches in terms of isolation, 1954: Dr. Alfredo instructed Dr. Sta Ana to
diagnosis, and control. prepare a training program syllabus based
on a 6-month laboratory training with a
Filipinos don't have the training and skills certificate issued upon
about laboratory works.
Dr. Tirso Briones joined the 2 doctors in the Roda at the Public Health Laboratory in
training program Quiricada Street in Sta. Cruz, Manila which
still stands to this day.
MRS. WILLA HILGERT HEDRICK
The MANILA SANITARIUM and HOSPITAL
American medical practitioner and a BEGAN in July 1929 as a clinic managed by
missionary of the Seventh-Day Adventist Dr. Horace A. Hall, a medical missionary.
Church to the Philippines
During WWII 1947-1949, building was
Founder of Medical Technology course and renovated
introduced to Manila Sanitarium and
Hospital (now Manila Adventist Medical PROFESSIONAL ETHICS
Center) at Pasay City and Philippines.
In the world of professional practice in the
Union College (now Adventist University Philippines, a medical technologist is
of the Philippines) at Baesa, Caloocan City mandated to observe the Code of
(now Silang, Cavite) (1954) Professional Ethics at all times.
The opening of Suez Canal facilitated the CHED MEMORANDUM ORDER FOR
dissemination of information from West to MEDICAL TECHNOLOGY EDUCATION AND
the East. POLICIES
f. To have custody of all the records of the k. To authorize any officer of the Commission
various Boards, including examination to administer oaths
papers, minutes of deliberation, records of
administrative causes and investigations and l. To supervise foreign nationals who are
examination results for control and authorized by existing laws to practice their
disposition professions either as holders of a certificate of
registration and a professional identification
g. To determine and fix the amount of fees to card or a temporary special permit in the
be charged and collected for examination, Philippines
registration, registration without
examination, professional identification card, m. to monitor the performance of schools in
certification, docket, appeal, replacement, and licensure examinations and publish the
accreditation, including surcharges and other results thereof in a newspaper of national
fees not specified under the provisions of circulation
Republic Act 4065 as amended by Republic
Act 6511 or to charge and collect reasonable n. To adopt and institute a comprehensive
fees at the rates higher than the rates rating system for universities, colleges, and
provided thereunder subject to the approval training institutes based on the passing ratio
by the Office of the President and overall performanceof students in board
examination.
h. To appoint subject to the Civil Service laws,
rules, and regulations, officials and employees o. To exercise administrative supervision over
of the Commission necessary for the effective the various professional regulatory boards
performance of its functions and and its members
responsibilities
p. To adopt and promulgate such rules and
i. To submit and recommend to the President regulations as may be necessary to effectively
of the Philippines the names of implement policies with respect to the
licensed/registered professionals for regulation and practice of the professionals.
appointment as members of the various
Professional Regulatory Boards from among q. To implement the program for the full
those nominated to fill up vacancies pursuant computerization of all licensure examinations
to the provisions of Executive Order No. 496, given by the various professional regulatory
Series of 1991 boards including the registration of
professionals not later than the year 2003 and
other operations of the Commission.
r. To investigate or upon the filing of a verified regulatory laws, decrees, executive orders,
complaint, any member of the Professional and other administrative issuances.
Regulatory Boards for neglect of duty,
incompetence, unprofessional, unethical, REGIONAL OFFICES - the Commission is
immoral, or dishonorable conduct, a hereby authorized to create regional offices as
commission of irregularities in the licensure may be necessary to carry out their functions
examinations which taint or impugn the mandated under this Act.
integrity and authenticity of the results of the
said examination and, if found guilty, to SECTION 9: POWERS, FUNCTIONS, AND
revoke or suspend their certificates of RESPONSIBILITIES OF THE VARIOUS
registration and professional licenses/ PROFESSIONAL REGULATORY BOARDS
identification cards and to recommend to the a. To regulate the practice of the
President of the Philippines their suspension professions in accordance with the
or removal from office as the case may be provisions of their respective
professional regulatory laws
s. To issue summons, subpoena, and b. To monitor the conditions affecting
subpoena duces tecum in connection with the the practice of the profession or
investigation of cases against officials and occupation under their respective
employees of the Commission and the jursidictions and whenever necessary,
members of the Professional Regulatory adopt such measures as may be
Boards; deemed proper for the enhancement
of the profession or occupation
t. To hold in contempt an erring party or c. To delegate the hearing or
person only upon application with a court of investigation of administrative cases
competent jurisdiction filed before them except in cases
where the issue or question involved
u. To initiate an investigation, upon complaint strictly concerns the practice of the
under oath by an aggrieved party, of any profession or occupation, in which
person, whether a private individual or case, the hearing shall be presided
professional, local/foreign, who practices the over by at least one member of the
regulated profession or occupation without Board concerned assisted by a
being authorized by law. Legal/Hearing officer of the
Commission
v. to prepare an annual report of d. To conduct, through the Legal Officers
accomplishments on the programs, projects, of the Commission, summary
and activities of the Commission during the proceedings on minor violations of
year for submission to Congress after the their respective regulatory laws,
close of its calendar year and make violations of the rules and regulations
appropriate recommendations on issues issued by the boards to implement
and/or problems affecting the Commission, their respective laws
the Professional Regulatory Board, and the e. Subject to final approval by the
various professions under its jurisdiction, and Commission, to recommend
registration without examination and
w. To perform such other functions and duties the issuance of corresponding
as may be necessary to carry out the certificate of registration and
provisions of this Act, the various professional professional identification card
f. After due process, to suspend, revoke, ▹ the amount necessary tocarry out the initial
or reissue, re-instate certification of implementation of this Act shall be charged
registration or licenses for causes against the current year’s appropriations of
provided by law the PRC. Thereafter, such sums as may be
g. To prepare, adopt, and issue the necessary for the continued implementation
syllabi or tables of specifications of of this Act shall be included in the succeeding
the subjects for examinations in General Appropriations Act
consultation with the academe
h. To prepare an annual report of SECTION 14: AUTHORITY TO USE INCOME
accomplishments on programs, ▹in addition to the annual appropriations of
projects, and activities of the Board the Commission provided under the annual
during the year of submission to the General Appropriations Act, the Commission
Commission after the close of each is hereby authorized to use its income not
calendar year and make appropriate exceeding the amount of 45 million pesos a
recommendations on issues or year for a period of 5 years after the
problems affecting the profession to effectivity of this Act.
the Commission
SECTION 15: PENALTIES FOR
SECTION 10: COMPENSATION OF THE MANIPULATION AND OTHER CORRUPT
MEMBERS OF THE PROFESSIONAL PRACTICES IN THE CONDUCT OF
REGULATORY BOARDS PROFESSIONAL EXAMINATIONS
▹ MEMBERS - two salary grades ower than
the salary grade of the Commissioners SECTION 16: PENALTIES FOR VIOLATIONS
OF SECTION 7
SECTION 11: PERSONS TO TEACH
SUBJECTS FOR LICENSURE EXAMINATION SECTION 17: IMPLEMENTING RULES AND
ON ALL PROFESSIONS REGULATIONS
▹ all subjects for licensure examinations shall ▹ within 90 days after the approval of this Act,
be taught by persons who are holders of valid the PRC, together with representatives of the
certificates of registration and valid various PRB and accredited professional
professional licenses of the progression and organizations, the DBM and the CHED shall
who comply with the other requirements of prepare and promulgate the necessary rules
the CHED and regulations needed to implement the
provisions of this Act
SECTION 12: ASSISTANCE OF LAW
ENFORCEMENT AGENCY SECTION 18: TRANSITORY PROVISIONS
▹ any law enforcement agency shall, upon call ▹ the incumbent Commissioners -
or request of the Commission or of any Chairperson
Professional Regulatory Board, render ▹ 2 incumbent Associate Commissioners -
assistance in enforcing the regulatory law of Commissioners
the profession including the rules and ▹ incumbent Executive Director - Assistant
regulations promulgated there under by Commissioner
prosecuting the violators thereof in
accordance with law and the rules of court SECTION 19:
AO 27 s. 2007
CLASSIFICATION OF CLINICAL
LABORATORIES
OWNERSHIP a. Government
b. Private
INSTITUTIONAL a. Institutional-based
CHARACTER b. Freestanding
TERTIARY CATEGORY
▹ ANATOMIC PATHOLOGY - surgical
a. Secondary category lab
● Immunology
exams
● Histopathologic
b. Special chemistry
● Cytology
c. Special hematology
● Autopsy procedure
d. Immunology and
● Forensic
serology,
● Molecular pathologic techniques
e. Microbiology - Aerobic &
▹ RISK GROUP 1 - agents that are not
anaerobic
associated with diseases in healthy adult
MIN. SPACE REQUIRED: 60 sq.m
humans
▹ PPE is expected to wear
▹ PERSONNEL are supervised by a
MINIMUM PRIMARY CATEGORY SCIENTIST which previous training in
FACILITIES a. Clinical centrifuge microbiology or related field
REQUIRED b. Hemocytometer ▹PATHOGEN TYPE - agents that present
c. Microhematocrit minimal potential hazard to personnel and
centrifuge the environment
d. Microscope with OIO, EXAMPLES
e. Hemoglobinometer or ▹ Bacillus subtilis
its equivalent ▹ E. coli K12 & E. coli
f. Differential blood cell ▹ Adeno-associated virus (AAV)
counter or its equivalent
BIOSAFETY LEVEL 2
SECONDARY CATEGORY ▹ containment, moderate risk, disease of
a. Primary lab varying severity
equipment/instruments ▹ RISK GROUP 2 - agents that are not
b. Refrigerator associated with diseases that are rarely
c. Photometer or its serious and for which preventive or
equivalent therapeutic interventions are often available
d. Water bath or its ▹ PERSONNEL - processes human derived
equivalent specimens such as blood, body fluids, tissues
e. Time or its equivalent and to some extent, human cell lines in which
the organism causing the disease is unknown
TERTIARY CATEGORY ▹ PPE, SECONDARY BARRIERS LIKE sink,
a. Secondary lab ▹waste decontamination facilities to reudce
equip/instruments the transmission of biohazard waste &
b. Incubator biosafety cabinet
c. Analytical balance ▹ PATHOGEN TYPE - agents associated with
d. Rotator human disease and pose moderate hazards to
e. Serofuge or its personnel and the environment
equivalent EXAMPLES
f. Autoclave ▹ Influenza
g. Drying oven ▹ HIV
h. Biosafety cabinet or its ▹ Lyme disease
equivalent ▹ Staph aureus
▹ Salmonella sp
WORLD HEALTH ORGANIZATION ▹ Herpes simplex virus
CLASSIFICATION ▹ Adenovirus
▹ It recognizes four levels of laboratories
depending on their capacity BIOSAFETY LEVEL 3
▹ high containment, aerosol transmission,
BIOSAFETY LEVEL 1 serious/potentially lethal disease
▹ No containment, defined organisms, and ▹ RISK GROUP 3 - agents that are not
unlikely to cause disease associated with serious/lethal human
diseases for which preventive/therapeutic
interventions may be available REPUBLIC ACT NO. 4688
▹ PATHOGEN TYPE - indigenous/exotic
agents with potential to be transmitted via SECTION 1 ▹ any person, firm or corporation,
respiratory routes and that can cause severe operating and maintaining a clinical
or sometimes fatal infection laboratory in which body fluids, tissues,
▹ EQUIPMENT/INSTRUMENTS - biosafety secretions, excretions, and radioactivity from
cabinet with gas-tight aerosol generation beings or animals are analyzed for the
chamber determination of the presence of pathologic
EXAMPLES organisms, processes and/or conditions in
▹ Mycobacterium tuberculosis the persons or animals from which they were
▹ Bacillus anthracis obtained, shall REGISTER AND SECURE A
▹ HIV LICENSE ANNUALLY AT THE OFFICE OF
THE SECRETARY OF HEALTH: provided that
BIOSAFETY LEVEL 4 government hospital laboratories doing
▹ max containtment, “exotic” high risk agents, routine or minimum laboratory examinations
life-threatening disease shall be exempt from the provisions of this
▹ RISK GROUP 4 - extremely dangerous and section if their services are extensions of
exotic agents that can transmitted through government regional or central laboratories.
the air; have usually not available vaccine or
therapeutic cure SECTION 2 ▹It shall be unlawful for any
▹ PATHOGEN TYPE - dangerous and exotic person to be professionally in-charge of a
agents that pose a high risk of registered clinical laboratory unless he is a
aerosol-transmitted laboratory infections and LICENSED PHYSICIAN DULY QUALIFIED IN
life-threatening disease LABORATORY MEDICINE AND
▹ PERSONNEL - required to wear full-body, AUTHORIZED BY THE SECRETARY OF
air-supplies positive-pressure suits HEALTH such authorization to be renewed
▹ EQUIPMENT/INSTURMENTS - specialized annually
ventilation and waste management system; ▹ No license shall be granted or renewed by
facility operates in a separate building the Secretary of Health for the operation and
EXAMPLES maintenance of a clinical laboratory unless
▹ Ebola virus such laboratory is under the administration,
▹ Marbug virus direction and supervision of an authorized
▹ Lassa virus physician, as provided for in the preceding
paragraph.
AO NO. 2007-0027
▹ CLINICAL LABORATORY STAFF SECTION 3▹ the SECRETARY OF HEALTH,
▹ the revised rules and regulations of through the Bureau of Research and
governing the licensing and regulation of Laboratories shall be charged with the
clinical laboratory should be responsibility of strictly enforcing the
▹ HEADED by a REGISTERED MEDICAL provisions of this Act and shall be authorized
TECHNOLOGIST and to issue such rules and regulations as may be
▹ MANAGED by a PATHOLOGIST who is duly necessary to carry out its provisions
certified by a Philippine Board of Pathology SECTION 4▹any person, firm, or corporation
▹ The number of Medtech staff in a lab who violates any provisions of this Act or the
depends on the workload and the services rules and regulations issued thereunder by
provided by the institution. the Secretary of Health shall be punished with
IMPRISONMENT FOR NOT LESS THAN ONE ▹ Designation of national reference
MONTH BUT NOT MORE THAN ONE YEAR, laboratories and transfer of corresponding
OR BY A FINE OF NOT LESS THAN 1,000 equipment, instruments, supplies, specimens,
NOR MORE THAN 5,000, OR BOTH SUCH and records form the bureau of Research and
FINE AND IMPRISONMENT, at the discretion laboratories to the designated national
of the court reference laboratories.
SECTION 5 ▹ if any section of part of this Act
shall be adjudged by any court of competent NATIONAL REFERENCE LABORATORY
jurisdiction to be invalid, the judgement shall ▹ A laboratory in a government hospital that
not affect, impair or invalidate the remainder has been designed by the DOH to provide
thereof special functions and services such as the
following:
SECTION 6▹ the sum of 50,000 or so must a. Confirmatory testing
thereof as may be necessary, is hereby b. Surveillance
authorized to be appropriated, out of any c. Resolution of conflicts
funds in the National Treasury not otherwise d. Training and research
appropriated, to carry into effect the e. Evaluation of kits & reagents
provisions of this Act. f. External quality assessment program
Delusions
SALIVA SPECIMEN
TYPES OF SPECIMEN COLLECTION the selection of the ASP subject to the
1. SINGLE approval of the Dangerous Drug
▹ entirely placed in a single 60mL bottle Board
2. SPLIT PROFICIENCY TESTING
▹ specimen is collected at same time, but ▹ NRL shall conduct a continuing assessent of
placed in 2 separate containers at least 30mL the proficiency of Screening and Confirmatory
each labs.
▹ A laboratory that faisl to ass proficiency test
INVALID URINE SPECIMEN conducted by the NRL shall be given another
● Adulterated, substituted & diluted test not earlier than 1 month after the failed
● Improperly collected, handled & test
stored ▹However, failure to pass proficiency test
● Improperly documented shall result in the suspension of its
accreditation
WAYS OF TAMPERING SPECIMEN ▹ SUSPENSION SHALL BE LIFTED ONLY -
● Dilution after passing the 2ND proficiency test
● Adulteration ▹ Failure to pass the second proficiency test
● Substitution shall result in the revocation of its
accreditation
SPECIMEN DONOR IDENTIFICATION
● Photo ID (driver’s license, employee CLIENT/DONOR OF DRUG TESTING
ID, passport, etc) LABORATORIES
● Identification by authorized agency
MANDATORY DRUG RANDOM DRUG
representative TESTING TESTING
● Any other ID allowed by agency’s
workplace drug testing plan Driver’s license Students of secondary &
tertiary
STORAGE OF LABORATORY RESULTS AND
Firearm’s license Officers and employees
SPECIMENS of public and private
● Retention of Records for a Minimum offices whether
period Prescribed by the DOH domestic/overseas
● Screening laboratory must keep
specimen with negative result for a Military, police and
other law enforcers
minimum of 5 days upon receipt of
result. Criminal offense;
● In case the result is not retrieved by penalty of
the Client/Donor the laboratory has imprisonment of not
the option to discard the specimen less than 6 years and 1
day
after 5 days
Candidate for public
INFORMATION TECHNOLOGY office (national/local)
REQUIREMENTS
● The laboratory shall have access to 1 Persons
apprehended/arrested
duly authorized Application Service
for violating the
Provider (ASP) provisions
● DOH shall formulate the Terms of
Reference/Request for Proposal for
VALIDITY OF THE TEST RESULT
▹ 1 year period from the date of issue CONFIRMATORY LABORATORY - absence of
GC-MS nor HPLC-MS
▹ HPLC with photo diode array is nor more
SCREENIN CONFIRMATORY
G LAB LAB than 2 years
▹ TLC (Thin Layer Chromatography)
REQUIRED Document Certification for
DOC FOR ation of Quality Standard RA 10586
ACCREDIT Quality System from a “ANTI-DRUNK AND DRUGGED DRIVING
ATION Control DOH-recognized
ACT OF 2013”
Program certifying body
▹DATE OF EFFECTIVITY: MAY 27, 2013
VALIDITY 1 year 2 years ▹PRESIDENT: Benigno S. Aquino III
OF THE
COA ● ALCOHOL - alcoholic beverages
classified into beer, wine, and distilled
VIOLATIONS spirits, the consumption of which
1. Issuance of false/fraudulent drug test produces intoxication
results ● BREATH ANALYZER - equipment
2. Failure to protect the confidentiality which can determine the blood
3. Failure to participate/pass the alcohol concentration level of a
proficiency testing person through testing of his breath
4. Conviction of the owner/manager of a ● CHEMICAL TESTS - breath, saliva,
laboratory urine, or blood tests to determine the
5. Failure to refer the positive screening blood alcholo concentration level
test (confirmatory lab) and/or positive indication of
6. Any other cause which materially dangerous drugs and similar
affects the ability of the lab to ensure substances in a perosn’s body
the full reliability and accuracy of ● DRIVING UNDER THE INFLUENCE
drug test and the accurate reporting OF ALCOHOL - act of operating a
of results motor vehicle while the driver’s blood
7. Failure on the part of the medical alcohol concentration level has, after
facility to submit documentation of being subjected to a breath analyzer
Quality Control Program (screening test, reached the level of intoxication,
lab) and Certification of Quality as established jointly by DOH,
Standard System from a NAPOLCOM, & DOTC
DOH-recognized certifying body ● FIELD SOBRIETY TEST - to
(confirmatory lab) within 6 months standardized tests to initially asses
8. Refusal to allow survey (Bureau or and determine intoxication, such as
CHD) the horizontal gaze nystagmus, the
9. Contrary to the accepted clinical walk-and-turn, the one-leg stand, and
laboratory practices other similar tests as determined
jointly by the DOH, NAPOLCOM &
TRANSITORY PROVISIONS DILG
▹ NRL - toxicology of the DOH is established
and operational SECTION 6
▹ Dangerous Drugs-Board-Laboratory shall ▹ Drug testing will only be conducted for
act as the NRL those driving under the influence (DUI)
▹ over-speeding, weaving, lane straddling,
swerving VIII. REPUBLIC ACT 7722
AN ACT CREATING THE COMMISSION ON
SECTION 7: MANDATORY ALCOHOL AND HIGHER EDUCATION, APPROPRIATING
CHEMICAL TESTING OF DRIVERS FUNDS FOR OTHER PURPOSES
INVOLVED IN MOTOT VEHICULAR
ACCIDENTS CHED
▹ Vehicular accident = loss of human life/ ▹ CREATED: MAY 18, 1994 through the
physical injuries passage of RA no. 7722, or the Higher
▹SUBJECTED TO: Chemical tests, drug Education Act of 1994.
screening test, and if necessary, a drug ▹ designed to act as a collegial body in
confirmatory test (RA NO. 9165) formulating plans, policies, and strategies
relating to higher education and the operation
PENALTIES FOR DRIVING UNDER THE of CHED.
INFLUENCE (DUI) RANGE FROM
- 3 months in prison & fine of PHP EDCOM REPORT
20,000 ▹ Pointed the seriousness of the present
- Perpetual revocation of the driver’s education system
license, a fine of PHP 500,000 and ▹ was translated into the enactment of RA
longer prison term 7722; creating the CHED in 1995, to supervise
the tertiary degree programs.
CHED
▹part of the broad agenda of reforms on the
country’s education system by the
Congressional Commission of Education
(EDCOME) in 1992
▹ Part of this reform was the tri focalization of
the education sector into 3 governing bodies:
1. CHED for tertiary and graduate
education
2. DepEd for basic education
3. Tech. educ. & Skills Development
(TESDA) for technical-vocational and
middle-level education
EFFLUENT
▹ discharge from known sources passed into a
body of water/land, or wastewater flowing
out of a manufacturing plant, industrial plant
including domestic, commercial and
recreational facilities