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NURSING*RADTECH*DENTISTRY*CRIMINOLOGY*MIDWIFERY*MEDTECH

LET*PSYCHOMET*RESPIRATORY THERAPY*CIVIL SERVICE*NAPOLCOM


NCLEX*DHA*HAAD* PROMETRIC* UK-CBT

MEDICAL TECHNOLOGY LAWS WITH LABORATORY MANAGEMENT


Charles Urias Arconado, RMT,9th Placer

QUICK FACTS

1. CMO no. 14 s. 2006 consists of policies, standards and guidelines for medical technology education.
2. A Medical Technology student graduate at the age of 20 can take the board exam.
3. TAT (Turn Around Time) starts upon the receipt of the request.
4. A Medical Technologist shouted and insulted his co-worker infront of the interns; he violated the Code of Ethics.
5. Upon your arrival at the laboratory, you’ve noticed that one of the lights is busted, you have to make an incident
report about it.
6. Revocation of license is associated with unanimous vote.
7. Suspension of license is associated with majority vote.
8. The one who approved the Board of Examiners is the President of the Philippines.
9. The implementation of RA 5527 was in June 21, 1969.

MEDICAL TECHNOLOGY LAWS

RA 5527 - The Philippine Medical Technology Act of 1969


AMENDMENTS:
 RA 6138 (3 sections) August 31, 1970
- the first amendment of RA 5527 (overall)
 PD 498 (11 sections) June 28, 1974
– the first amendment of RA 5527 under Martial Law
- “The Greatest Amendment”
 PD 1534 (3 sections) June 11, 1978

 RA 6138 - 16, 21, 22


 PD 498 - 2, 3, 4, 7, 8, 11, 13, 16, 17, 21, 29
 PD 1534 - 3, 8, 13

Important selected sections:


SECTION 2 ~ Definition of Terms - As used in this Act, the following terms shall mean:
a. Practice of Medical Technology - A person shall be deemed to be in the practice of medical technology within the
meaning of this Act, who shall for a fee, salary or other compensation or reward paid or given directly or indirectly
through another, renders any of the following professional services for the purpose of aiding the physician in the
diagnosis, study and treatment of diseases and in the promotion of health in general:

1. Examination of tissues, secretions and excretions of the human body and body fluids by various electronic,
chemical, microscopic, bacteriologic, hematologic, serologic, immunologic, nuclear, and other laboratory
procedures and techniques either manual or automated;
2. Blood banking procedures and techniques;
3. Parasitologic, Mycologic and Microbiologic procedures and techniques;
4. Histopathologic and Cytotechnology; provided that nothing in this paragraph shall inhibit a
duly registered medical laboratory technician from performing histopathologic techniques and procedures.
5. Clinical research involving patients or human beings requiring the use of and/or application of medical
technology knowledge and procedures;
6. Preparations and standardization of reagents, standards, stains and others, provided such reagents, standards,
stains and others are exclusively for the use of their laboratory;
7. Clinical laboratory quality control;
8. Collection and preservation of specimens;

Provided, That any person who has passed the corresponding Board examination for the practice of a profession
already regulated by existing law, shall not be subject to the provisions of the last four preceding paragraphs if
the performance of such acts or services is merely incidental to his profession.

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

c. 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 havingpassed the prescribed course (Bachelor of Science in Medical Technology/Bachelor of Science in
Hygiene) of training and examination isregistered under the provision of this Act.

d. Medical Laboratory Technicians - A person certified and registered with the Board as qualified to assist a
medical technologist and/or qualified pathologist in the practice of medical technology as defined in this Act.

e. Accredited Medical Technology Training Laboratory - A clinical laboratory, office, agency, clinic, hospital or
sanitarium duly approved by the Department of Health2 or its authorized agency.

f. 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.

g. Council - The council of medical technology education established under this Act.

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

SECTION 14 ~ Inhibition Against the Practice of Medical Technology.- No person shall practice or offer to
practice medical technology as defined in this Act without having previously obtained a valid certificate of registration
from the Board provided that registration shall not be required of the following:
a. Duly registered physicians.
b. Medical technologist from other countries called in for consultation or as visiting or exchange professors to colleges or
universities: Provided, they are only practicing the said function.
c. Medical technologists in the service of the United States Armed Forces stationed in the Philippines rendering services as
such for members of the said forces only.

I. THE TRAINING: Council of Medical Technology Education / Technical Panel


SECTION 3 ~ Council of Medical Technology Education, Its Composition
COUNCIL OF MT EDUCATION
1. Chairman – CHED (7 years)
2. Vice-chairman – PRC Chairperson (5 years)
Members: (2-4 years)
• PAMET
• PASMETH
• PSP
• DOH
• Deans of colleges and universities

SECTION 4 ~ Compensation and Traveling Expenses of Council Members


SECTION 5 ~ 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 to be allowed to take up the medical technology course in
each school, taking into account the student-instructor ratio and the availability of facilities for instruction.
c. To approve medical technology schools meeting the requirements and recommend closure of those found to be
substandard.
d. To require all medical technology schools to submit an annual report, including the total number of students
and instructors, list of facilities available for instruction, a list of their recent graduates and new admissions, on or

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before the month of June.


e. To inspect, when necessary, the different medical technology schools in the country in order to determine
whether a high standard of education is maintained in said institutions.
f. To certify for admission in to an undergraduate internship students who have satisfactorily completed three
years of the medical technology course or its equivalent and to collect from said student 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.

Report CARD
- Recommend required subjects
- Certify students for internship
- Accreditation of schools of MT and training clinical lab.
- Refresher course program (formulate and recommend)
- Determine the number of students to be admitted in the school

SECTION 6 ~ Minimum Required Course


CMO no. 14 s. 2006 – 6 months internship
SECTION 13 ~ Accreditation of Schools of Medical Technology and of Training Laboratories

II. THE PRACTICE: Medical Technology Board


SECTION 7 ~ Board of Examiners for Medical Technology
COMPOSITION OF THE MEDTECH BOARD
1. Chairman: Pathologist (Marilyn Barza)
2. Members : 2 RMTs (Marilyn Atienza and Marian Tantingco)
“House Bill #3502”
• Replace the position of the pathologist
SECTION 8 ~ Qualifications of Examiners
PAMET will assign the members
PSP will assign the chairman
*PAMET and PSP  PRC  President of the Philippines
QUALIFICATIONS:
• Filipino (Natural born/Naturalized citizen)
• Good moral character
• At least 10 years of professional experience
• Not affiliated with MT schools at least 2 years
 Direct affiliation – employment
 Indirect affiliation – blood types (relative)
SECTION 9 ~ Executive Officer of the Board
PRC Chairperson
SECTION 10 ~ Compensation of Members of the Board of Examiners for Medical Technology
SECTION 11 ~ Functions and Duties of the Board (Sections 20-26, 27, 29)
a. Administer the provisions of this Act;
b. Administer oaths in connection with the administration of this Act;
c. Issue, suspend and revoke certificates of registration for the practice of medical technology and medical
laboratory technician;
d. Look into conditions affecting the practice of medical technology in the Philippines and, whenever necessary,
adopt such a measure may be deemed proper for the maintenance of good ethic and standards in the practice of
medical technology;
e. Investigate such violations of this Act or of the rules and regulations issued thereunder as may come to the
knowledge of the Board and, for this purpose issue subpoena and subpoena duces tecum to secure appearance
of witnesses and production of documents in connection with charges presented to the Board; and
f. Draft such rules and regulations as may be necessary to carry out the provisions of this Act: Provided, that the
same shall be issued only after the approval of the President of the Philippines;
g. To determine the adequacy of the technical staff of all clinical laboratories and blood banks before they could

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be licensed with the Department of Health in accordance with R.A. No. 4655 and 1517;
h. To prescribe the qualifications and training of medical technologists as to special fields of the profession and
supervise their specialty examination conducted by the professional organization of medical technologists
accredited by the Professional Regulation Commission;
i. To classify and prescribe the qualification and training of the technical staff of clinical laboratories as to: Medical
Technology; Medical Technologist; Senior Medical Technologist; Medical Technologist and Medical Laboratory
Technician.
SECTION 12 ~ Removal of Board Members
SECTION 20 ~ Oath Taking
SECTION 21 ~ Issuance of Certificate of Registration  ID
- 4 Signatures [Chairman, (2) Members, PRC Chairperson]
SECTION 22 ~ Fees
SECTION 23 ~ Refusal to Issue Certificate
I - Incurable communicable disease
C – Criminal offense not less than 6 years
U – Unsound mind
L – Less than 21 years
SECTION 24 ~ Administrative Investigation – Revocation or Suspension of Certificates
HEARING (Investigation)
MedTech Board will do the Tribunal and it is composed of 1 legal officer and 2 MTB members
2 out of 3 votes – Majority vote
3 out of 3 votes – Unanimous vote
*GROUNDS FOR SUSPENSION AND REVOCATION
• 3P’s
Practicing without Pathologist
Practicing without license
Practicing using other MT license
• 3F’s
Faking lab result
Fail to display COR in the lab
Faking COR
• Negligence
• Malpractice
• Degrading act
SECTION 25 ~ Appeal
FROM SUSPENSION TO REVOCATION
---did not surrender license within 30 days
Appeal within 15 days at the PRC, after 15 days, decision will be final
SECTION 26 ~ Reinstatement, Reissue, or Replacement of Certificates
SECTION 28 ~ Roster of Medical Technologists
SECTION 29 ~ Penal Provisions

III. THE EXAMINATION: MT Licensure Examination


SECTION 15 ~ Examination
SECTION 16 ~ Qualification of Examination
a. Is in good health and is of good moral character;
b. Has completed a course of at least four (4) years leading to the degree of Bachelor of Science in Medical Technology or
Bachelor of Science in Public Health conferred by a recognized school, college or university in accordance with this Decree
or having graduated from some other profession and has been actually performing medical technology for the last five (5)
years prior to the date of the examinations, if such performance began prior to June 21, 1969.
SECTION 17 ~ Scope of Coverage and Examination
MTB  (10 days) PRC  Pres.
SECTION 18 ~ Report of Rating
SECTION 19 ~ Ratings in the Examination
GWA = 75% above (reported as 2 decimal points)
** not failed 60% of the subjects
**no less than 50% in any of the 4 major subjects
SECTION 27 ~ Foreign Reciprocity
*Foreigners are allowed to take the board exam if and only if there is an agreement with their country. (3 years residency)

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*Non-MedTech graduate working for 8 years in lab or MT graduate working for 3 years in lab are allowed to take the
board exam and be given a license (before submission of RA 5527)
*Last day of submission 20 days before the exam

RA 4688 - Clinical Laboratory Act of 1966


*Latest implementing rules (AO no. 27 s. 2007)
 Clinical Pathology Laboratory
 Anatomic Pathology Laboratory
 Scope
Scope of 4688
• Clinical government extension laboratory is exempted to follow the rule of 4688 (barangay, government)
Example of tests: Malarial Screening, TB Screening, Cervical Cancer Screening
 Classification of Lab
- Institutional Character
- Function
- Service capabilities (Primary, Secondary, and Tertiary Laboratory)
SERVICES:
1. Routine Hematology, Urinalysis, Fecalysis
2. Blood Typing (hospital based)
3. Qualitative Platelet Count
4. Routine Chemistry
5. Crossmatching, KOH, Gram Staining (hospital based)
6. Quantitative Platelet Count
7. Special tests in Hematology and Chemistry
8. Immunology and Microbiology
*PRIMARY LABORATORY – 1, 2, 3
*SECONDARY – 1, 2, 3, 4, 5, 6
*TERTIARY – 1, 2, 3, 4, 5, 6, 7, 8
Limited Services – convenience
- within a medical facility
- e.g. Hemodialysis (CBC, BUN, Creatinine)
 Supervision – Pathologist (4 clinical laboratories and 1 blood bank) or Physician
*Physician with training in Lab Management and Lab QA/QC in DOH can supervise a lab
- 3 months training
- 1 clinical lab = Primary or Secondary
 Prescribed number of MT
*License Requirements:
 Where? BHFS (specific) or DOH
 When? (renewal ) 90 days before expiration
 Validity = 1 year and expire on the last day of the year
 Inspection = 2 years except for spot inspection
*Fail to display certificate upon inspection is punishable by 1 year or 12 months
 Changes in the laboratory = 15 days
 NRLs
*Lab Requests and Reports:
 Consultation between the Pathologist and Physician
*All reports must be signed by the Pathologist before releasing EXCEPT in cases of emergency
*Records:
 Clinical Pathology Lab Reports – 1 year
 Anatomic Pathology Lab Reports – indefinitely

RA 7719 - National Blood Services Act of 1994

RA 1517 RA 7719

--Guidelines establishing commercial BB --Phase-out commercial BB


--“Old Blood Banking Law” --non-profit

*Voluntarism

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*Classification of BB (AO no. 8 s. 2008)


*Important provisions
 Section 7 – Phase-out of Commercial Blood Banks
 Section 8 – Non-Profit Operation
 Section 9 – Regulation of Blood Services
*Penalties
 Over-pricing – revocation of license to operate
• 1-6 mos. in prison
• 5,000 – 50,000 fine
 No license
 12-20 years in prison
 50,000 – 500,000 fine
 Transfusing (or failing to discard) contaminated blood units
*Fail to dispose blood bag unit that is contaminated within 48 hours, the staff will be imprisoned for 10 years.
BLOOD SERVICE FACILITIES
- Blood Station – compatibility testing (WB and pRBC)
- Blood Collection Unit – recruit, screen, collect
- Blood Bank – compatibility testing to all blood products, screening, Coombs test, investigate
- Blood Center – centralized processing
- centralized testing
- collect blood to donor
*License to operate Blood Service Facilities is valid for 3 years (renew license 60 days before expiration).
BLOOD SERVICE FACILITY IS SUPERVISED BY:
- Pathologist
- Hematologist
- MD = 6 months training in DOH and he/she can only supervise Blood Station

RA 9165 - Comprehensive Dangerous Drugs Act of 2002


 Classification of Drug Testing Laboratories
- Institutional character
- Service capabilities
Screening Drug Testing Laboratory Confirmatory Drug Testing Laboratory
Qualitative Testing (+/-) Both Qualitative and Quantitative Testing

Immunochromatography GC-MS

Validity: 1 Year 2 years

Floor Area: 20 sq. m. 60 sq. m.

Work Area: 10 sq. m. 30 sq. m.

- Mandatory and random drug testing


MANDATORY DRUG TESTING RANDOM DRUG TESTING
Charged with criminal offense Students
Driver’s license Officials
Enforcers of law Employees
Firearm license
Government officials

- Drug analysts
Qualified Drug Analyst:
 RMT
 Pharmacist
 Chemist
 Chemical Engineer
- Training
- Reference lab for drug testing
- CHAIN OF CUSTODY – tracking where about of the samples
- CHALLENGE TEST:

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Spx (+)  Court Order  Submit Original Spx  EAMC (repeat test)
Specimen Retention:
- 5 days for (-) specimen
- 15 days for (+) specimen

TERMINOLOGIES:
Clandestine laboratory – secret lab / manufacturing facilities
Den / Dive / Resort – storage facilities / warehouse
Coddler – protector
PDEA – Philippine Drug Enforcement Agency

PENAL PROVISIONS
ILLICIT DRUGS PENALTY
10 grams of: opium, morphine, heroin, cocaine,
marijuana resin oil, designer drugs Life imprisonment
500,000 – 10,000,000
50 grams of shabu

500 grams of marijuana

VIOLATIONS ILLICIT DRUGS PRECURSOR SUBSTANCE


Importing, Selling, Trading,
Transporting, Distributing,
Maintaining Den, Manufacturing Life Imprisonment 12 - 20 years imprisonment
500,000 – 10,000 fine 100,000 – 500,000 fine

RA 5527 RA 4688 RA 7719 RA 9165


The Philippine Clinical Laboratory National Blood Comprehensive
Medical Act of 1966 Services Act of Dangerous Drugs
Technology Act of 1994 Act of 2002
1969
APPROVAL June 21, 1969 June 18, 1966 May 5, 1994 June 7, 2002

VALIDITY OF 3 years 1 year 3 years SDTL – 1 year


LICENSE CDTL – 2 years

SUPERVISION Pathologist Pathologist Pathologist SDTL - Pathologist,


MD (w/ training) Hematologist MD (training done
MD (w/ training) at EAMC)

CDTL –
Pathologist,
Licensed Chemist

PENALTIES 6 months – 2 1 – 12 months No license


years (50,000-500,000)
2,000 – 5,000
Overpricing
(5,000-50,000)

Failed to dispose
within 48 hrs.
(10years)

WHERE THEY GET BHFS (DOH) BHFS BHFS


THE LICENSE PRC

RA 8981 - PRC Modernization Act of 2000


Old PRC Law New PRC Law
PD 223 RA 8981

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July 23, 1973 Dec. 5, 2000


3-Man Commission: 3-Man Commission:
 1 Chairman / Commissioner  1 Chairman / Chairperson
 2 Associate Commissioners  2 Commissioners
Appointed by the President Appointed by the President
 9 years  7 years

QUALIFICATIONS:
• At least 40 years old
• With a valid license
• Familiar with the principles and methods of the PRC
• At least 5 years executive / management experience
FUNCTIONS:
• Administer and conduct licensure exam of the various profession
• Authorize to require refresher course
• Monitor the performance of schools in licensure examinations
• Approve and release board exam results and issue certificate of registration (COR)
• Recommend to the President the names of professionals for the appointment of the various boards
PROFESSIONAL REGULATORY BOARD (e.g. MTB)
• Regulate and monitor the practice of their respective professions
• Administer investigation
- The decision of the PRB shall become final after 15 days from the receipt of notice
• Prepare the syllabi of exams
• Prepare questions based on these syllabi
• Score and rate the exam and submit to PRC within 10 days from the last day of exam
• Serve as the CPE council
• CONTINUING PROFESSIONAL EDUCATION
- CPE council - MTB
- CPE providers
- Required number of CPE Units for all professions / 3 years
 60 for BS – Licensed
 30 for BS – Non licensed
- Required number of CPE Units for MT / 3 years
 90 – Licensed
 60 – Non Licensed
 45 – Licensed in province

RA 8504 – Philippine AIDS Prevention and Control Act of 1998


- Prevention and control of HIV/AIDS
- Protecting positive individuals
- HIV/AIDS info. and educ. program
- HIV/AIDS Monitoring System
 HIV Testing:
- Considers compulsory EXCEPT:
Charged with criminal offense
Donors
Necessary to resolve family issues
 Protection of HIV positive individuals:
- Considers compulsory HIV testing as unlawful
- Any act of discrimination is unlawful
- Social and health services must not be deprived
- Treating records as confidential
 Who can get the result?
- Patient
- Parent (minor)
- Legal guardian
- DOH

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RA 7170 – Organ Donation Act of 1991


Date of enactment: Jan. 7, 1992
Deceased Donors:
1. Testator – Donor (Donor’s Card)
2. Non-testator – Spouse, Children (>18 years old), Parent, Siblings (>18 years old), Guardian at the time of death

Qualification: >18 years old with sound mind

 Legatee – potential recipient

RA 6969 - Toxic Substances, Hazardous Wastes and Nuclear Waste Control Act of 1990
 This act seeks to protect the public health and environment from unreasonable risks posed by these substances
 Authorized agencies: DENR (Department of Environment and Natural Resources) and PNRI (Philippine
Nuclear Research Institute)

LAW TITLE DATE OF APPROVAL


RA 5527 The Philippine Medical Technology June 21, 1969
Act of 1969
RA 4688 (AO no. 27 s. 2007) Clinical Laboratory Act of 1966 June 18, 1966

RA 7719 (AO no. 8 s. 2008) National Blood Services Act of 1994 May 5, 1994

RA 9165 Comprehensive Dangerous Drugs June 7, 2002


Act of 2002
RA 8981 PRC Modernization Act of 2000 December 5, 2000

RA 8504 Philippine AIDS Prevention and February, 13, 1998


Control Act of 1998
RA 7170 Organ Donation Act of 1991 January 7, 1992

RA 6969 Toxic Substances, Hazardous


Wastes and Nuclear Waste Control
Act of 1990
RA 10069 *May 7 is declared as the “Health 2012
Worker’s Day”
RA 10586 Anti-drunk and Drugged Driving Act
of 2013
RA 9288 Newborn Screening Act of 2004 April 7, 2004
RA 7722 Higher Education Act of 1994 May 18, 1994
CMO no. 14 series of 2006 Policies, Standards and Guidelines
for Medical Technology Education
CMO no. 6 series of 2008 Guidelines for the Accreditation of
Clinical Laboratories Involved in the
Training of Medical Laboratory
Science / Medical Technology
Interns

OTHER SIGNIFICANT INFORMATION:


1. MSUD, the most common inborn errors of metabolism in the Philippines, joins the list of the five
disorders in the newborn screening panel: congenital hypothyroidism, congenital adrenal hyperplasia,
galactosemia, G6PD deficiency, and phenylketonuria.

2.

Beloved PAMET
From various lands races and places
with grateful hearts we blend our voices
This day to our beloved. PAMET
from whence unity and love cometh.

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We join together in brotherhood


to live up to thine ideals we should
In fields of advancement and learning
Thy noble goals maybe our bearing.
Loyal and true we'll be to thee
Beloved PAMET this we say,
for service to God and humanity
With joy we sing for thee till eternity.

Music: Francis Jerota Pefanco


Lyrics: Hector Gentapanan Gayares, Jr.

3. PAMET PRESIDENT: Mr. Ronaldo E. Puno

4. PANUNUMPA NG PROPESYONAL
Ako, si (Pangalan), ng (Tirahan) ay taimtim na nanunumpa na itataguyod ko at ipagtatanggol ang
Saligang Batas ng Pilipinas, na ako ay tunay na mananalig at tatalima rito; na susundin ko ang mga batas, mga
utos na legal, at mga atas na ipinahayag ng mga sadyang itinakdang may kapangyarihan ng Republika ng
Pilipinas; at kusa kong babalikatin ang pananagutang ito, na walang ano mang pasubali o hangaring umiwas.
Taimtim pa rin akong manunumpa na sa lahat ng panahon at pook na kinaroroonan ay mahigpit akong
manghahawakan sa mga etikal at tuntuning propesyonal ng mga (Propesyon) sa Pilipinas, at marapat kong
gagampanan ng buong husay sa abot ng aking makakaya ang mga tungkulin at pananagutang iniatang sa isang
itinakdang (Propesyon).
Kasihan Nawa ako ng Diyos.

5. PRC OFFICIALS
PRC Chairman Hon. Teofilo S. Pilando, Jr.
PRC Commissioners Hon. Angeline T. Chua Chiaco
Hon. Yolanda D. Reyes

6. The Secretary of Health (Filipino: Kalihim ng Kalusugan) is the Cabinet of the Philippines member in charge of
the Department of Health. The current Secretary is Janette Garin.

7. CODE OF ETHICS
As I enter into the practice of Medical Technology, I shall:
 Accept the responsibilities inherent to being a professional.
 Uphold the law and shall not participate in illegal work.
 Act in a strict spirit of fairness to all and in a spirit of brotherhood toward other members of the profession.
 Accept employment from more than one employer only when there is no conflict of interest.
 Perform my task with full confidence, absolute reliability and accuracy.
 Share my knowledge and expertise with my colleagues.
 Contribute to the advancement of the professional organization and other allied health organizations.
 Restrict my praises, criticisms, views and opinions within constructive limits.
 Treat any information I acquired in the course of my work as strictly confidential.
 Uphold the dignity and respect of my profession and conduct myself a reputation of reliability, honesty and
integrity.
 Be dedicated to the use of clinical laboratory science to promote life and benefit mankind.
 Report any violations of the above principles of the professional conduct to authorized agency and
to the ethics committee of the organization.
To these principles, I hereby subscribe and pledge to conduct myself at all times in a manner befitting the
dignity of my profession.
Note:
~The Ethics Committee of PAMET (Philippine Association of Medical Technologists) is the one who regulates
the Code of Ethics.
~The original Code of Ethics was established in August 9, 1968.
~The revised Code of Ethics was established in March 7, 1997.
~The word “precision” is NOT stated in the Code of Ethics!

LABORATORY MANAGEMENT

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I. Management Process

A. Management of Planning

Henri Fayol
- proposed that the management process is a continuum of functions that the manager must perform to
ensure smooth operations of an organization.

Peter Ducker
- established the four basic management operations:
1. Planning
2. Organization
3. Directing
4. Controlling
Four main function
Planning - “work out in advance”
- thinking and analyzing portion of the management process
Organizing - gather together the necessary resources and people
- develop an organizational structure for putting the plan into action
Directing - leading where one sees the day-to-day tasks necessary to ensure smooth running of lab
Controlling - measurement and feedback mechanism of objectives
- checking up the goals established during the planning phase
- determines the success or failure and identify needed for modification

MANAGEMENT APPROACH
• Scientific Approach
• Systematic approach
• Phases of Management
• Bureaucratic Approach
• Rule centered
• Behavioral Approach
• Performance and Interpersonal approach
• System Approach
• Continuous process of interacting itself and environment
• Organization as an OPEN SYSTEM

What are the skills of Manager?


• Robert Katz:
1. Technical skill = Lab procedure
2. Human skill= interpersonal skill
3. Conceptual skill = knowledge

Setting goals and objectives


- it is imperative to distinguished goals and objectives.
GOALS – are broad long-term ambitions of the organization
OBJECTIVES – are specific short-term standards that allow the manager to achieve goals.
4 BASIC CHARACTERISTICS OF A GOOD OBJECTIVE
1. It is clearly defined and understood
2. It is obtainable and realistic
3. It has strict time period in which it is to be accomplished
4. It is measurable
Indeed must be SMART!

Principles of Leadership
1. Command responsibility

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a. Respondent superior – the leader is responsible for the action of his subordinates
b. Respondent inferior – the individual is responsible for his own actions
2. Unity of command – is having only one superior or one boss

Pygmalion effect
- which holds that people are expected to act in the way they are expected to act by their leaders.

McGregor Theory
 Theory X – managers believe that people are inherently lazy and dislike work, with no ambition and must be
coerced into performing their duties by constant supervision.
 Theory Y – managers believe that work is a natural part of life and people have high degree of ingenuity and
creativity
- Self learners
- Seek responsibility for their performance
- Exercise self-control
Theory Z
States that the managers assumed that people are self-controlled and self-regulated, characteristics of
workers contained in theory Y and that productivity and rewards are not the only objectives but issues such
as the quality work is crucial to their motivation

Leadership Styles
1. Autocratic – self centered
2. Democratic – shared authority
3. Bureaucratic – structure oriented
4. Laissez faire – permissive type
5. Charismatic- attraction seeker

Management of Change
• Comprehensive, cyclic, and structured approach for transitioning individuals, groups, and organizations from the
current state to a future state with intended business benefits

Process of Change
• Formulating the change
• Planning the change
• Implementing the change
• Managing the change
• Sustaining the change

ADDITIONAL NOTES:
1. Purpose - Not to show how precisely we can predict the future, but rather to uncover the things we must do
today in order to have future
2. Strategies - Strategies donate a general program of action implying commitment of emphasis and resources
to attain broad objectives.
3. Policies - are general statements of understanding which guide, or channel thinking and action in decision
making.

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4. Procedures - are plans that is establish a required method of handling future activities
- are truly guides to action, rather than to thinking, and they detail the exact manner in which a certain
activity must be accomplished
5. Rules - are required actions chosen from among alternatives. It requires that a specific and definite action can
be taken or not with respect to a situation
6. Programs - are complex goals, policies, procedures, task, assignments, steps to be taken, resources to be
employed and other elements necessary to carry out a given course of action
7. Budget - is a statement of expected results expressed in numerical terms
8. Departmentalization – grouping together of related activities to expedite the production process
- Involves concept of specialization
9. Decentralization - Process of having the decision-making process close to those who are actually performing
the work
10. Scalar Principle - involves concept of chain-of-command and career ladder.
11. Span control - number of individuals one person can effectively supervise within the limits of specific work
conditions
12. Exception principle - allows the manager and staff to do their job without having to check with a
supervisor about every details
13. Staffing - the setting of a long term goals and objectives for the number and types of personnel needed to
meet the labor requirements of the laboratory
14. Scheduling - matching the people presently working in the laboratory with current workload requirements
15. Division of work – willingness to work
16. Authority and responsibility – is the right to be respected by the people; One should be responsible in
doing the task assigned to him/her.
17. Chain of command – Scalar arrangement of persons to whom responsibility passes in a hierarchical level
18. Centralization – the leader has the power to fully control the people under him
19. Communication – ability to communicate effectively ( supervisor-subordinate )
20. Stability – is to maintain position and not to be dismiss without reason
21. Remuneration of personnel – refers to the salary or fringe benefits
22. Equity and justice – everybody must be treated equally
23. Esprit d’ corps – establishing a spirit of camaraderie and cooperation; establishing a good working
relationship.

II. Quality Assessment

• A quality management system can be defined as “coordinated activities to direct and control an
organization with regard to quality.”
-ISO
-CLSI

Quality Concepts
“Quality is like love, one knows what it is, but no one knows exactly how to describe or measure it”.
- To develop a plan to assess and ensure the quality of the services delivered by the laboratory, the manager
must have a full understanding of both the history and philosophy of quality as well as knowledge of specific
statistical technique and their application to the laboratory.

(1) Quality Control


- this refers to standards and techniques that measures the quality of the product in isolation
from the needs of the customer or patient.
- this relies heavily on quantitative statistical methods that focus on the final product as defined
by standards set by producer.
- this is also refers to specific activities directed toward monitoring the individual elements of care
- quality control in a laboratory medicine has been defined as the study of those errors, which are
responsibility of the laboratory and the procedures used to minimize them.
Quality control programs
- have been an integral part of the inspection system by the BIRL, Department of health.

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- the supervising pathologist should insure that the quality control program is organized for
periodic review or every major portion of the clinical laboratories and that the program can be documented
for the inspector.

QUALITY CONTROL
in the laboratory can be divided into major types
1. Internal Quality control
 Precision of laboratory tests
 Based on the results of control specimen/patient’s specimen
2. External Quality control
 Accuracy of laboratory tests
 Proficiency testing/EQAP (D.M. #86 s. 2000)
 Interlaboratory performance

(2) Quality Assurance


Overall activities conducted by the institution that are directed toward assuring the quality of
services provided.
QA focused on the recipient. Furthermore, QA focuses on the monitoring of outcomes or
indicators of care.
(3) TQM
A quality management program that includes each component in the creation process from the
acquisition of supplies to active follow-up after the product or service has been received by a delighted customer.
• JCI, ISO - organizations that conduct continuous performance improvement program
(4) QAI
- this is a quality management program that focuses on the success of the organization in
designing and achieving its sets of goals and objectives.
- JACHO established nine dimensions of performance that must be included and measured in the
design of the organization’s quality assessment and performance improvement plan such as:
 Efficacy
 Appropriateness
 Availability
 Timeliness
 Effectiveness
 Continuity
 Safety
 Efficiency
 Care and respect

WESTGARD RULES
James O. Westgard
He propounded the MULTI-RULE SYSTEM in the evaluation of the quality control data in
the medical laboratory particularly the multi-ranged controls used in clinical chemistry.

(1) 1 2S RULE – the run is accepted when both control result are within 2SD limits from the
mean value
(2) 2 3S RULE – the run is considered out of control when one of the control results
exceeds the 3SD limits
(3) 2 2S RULE – the run is rejected when both controls exceeds the mean value 2SD or the
mean 2SD limits
(4) R 4S RULE – the run is rejected when both controls exceed mean value 2SD limits and
one exceeds the mean 2SD limit or when the range of a group of controls exceeds 4SD
(5) 4 1S RULE – the run is rejected when four consecutive control results exceed the mean
1SD or the mean 1SD
(6) 10x RULE – the run is rejected when at least 10 consecutive control results fall on the
same side of mean

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BASIC QUALITY CONTROL STATISTICS


1) ACCURACY – closeness of a result to the actual value.
2) PRECISION – repeatability of test result
3) DATA POPULATION – it defines the items being studied at particular time
4) POPULATION SAMPLE – a part of population that is used to analyze the cha. Of
that population
5) MEAN – arithmetic ave. for all data contained in a sample population
6) SD – measurement of precision or the tendency of values in each population
7) CV – standard deviation expressed as a percentage

SENSITIVITY vs. SPECIFICITY


 Sensitivity = proportion with specific disease that gives a POSITIVE test result
- (+) disease; (+) test result
 Specificity = proportion of cases with no disease that gives a NEGATIVE test result
- (-) disease; (-) test results

Running Controls
• QC materials?
• Standard solution
• Contains a known concentration of analyte and used to calibrate an assay method or to verify
instruments calibration
• Blank solution
• Used to read out any absorbance caused by reagent or specimen
• Types:
• Test/serum blank
• Reagent blank
• Water blank

Characteristics of a Good Control Solution


• Stable for at least one year
• Same matrix as human samples
• Should span the clinically important range of the analyte
• Packed in convenient containers

When to run controls?


• At the beginning of shift
• When results are abnormally high/low
• After preventive and calibration maintenance
• When opening a new lot of reagent
• If not confident with the patient’s result

• In general, monitoring of analytic methods is done by assaying stable control samples and comparing the
observed values with the expected values

LABORATORY EVALUATION METHOD


1. LEVEY JENNING CHART
A control chart used to plot quality control values against previously set limits to determine if a
procedure is in or out of control
2. YOUDEN PLOT
A technique used to demonstrate and compare the performance of a laboratory on paired
samples with other laboratories using a common control lots or survey material
3. MULTI RULE ANALYSIS
a set of rules such as WESTGARD rules that are used for accepting or rejecting a control run

EXAMINATION OF CONTROL CHARTS


(1) Skewed curves
deviations from the symmetrical bell shaped appearance of a frequency polygon

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(2) TREND
a systematic drift in one direction away from the established mean
(3) DISPERSION
control or sample values that are widely scattered in an unusual and unexplained pattern around
the control chart
(4) SHIFT
A sudden switch of data points to another area of the control chart away from previous mean

CONCEPT ERROR
1. RANDOM ERROR
- an error that may occur at any time and place within the production process
- indicate inaccuracy
- need only to be closely monitored for possible occurrence
2. SYSTEMATIC ERROR
- an error that occur in a constant direction or pattern
- indicate imprecision
- occur in predictable direction
- need immediate remedial action
MISTAKES
- in addition to analytical factors that introduce bias and random variability into the analytical procedure,
laboratory analyses are also subject to MISTAKES.
SOME TYPES OF LABORATORY MISTAKES
1. Obtaining the specimen from the wrong patient
2. Specimen mix up
• Specimens labeled with wrong accession number
• Sera transferred to mislabeled tubes
• An improper cup number was recorded when a specimen was removed from the auto analyzer samples
wheel to insert an emergency specimen and all specimen on the wheel assigned false values
3. Incorrect chart readings
• Incorrect reading of auto analyzer peak
• Incorrect read off from the standard curve
• Read off from the standard curve assigned to wrong specimen
4. Dilution and calculation errors
• Analyst forgot to correct results for dilution
• Samples diluted be first shift technologist were analyzed by a second shift technologist who was not
informed of the prior dilution
• A newly employed analyst thought a 1 to 2 dilution meant 1 volume of serum and 2 volume of diluents
rather than 1 volume of each
5. Reagents and standards solution
• Distilled water rather than buffer was used to prepare a reagent
• pH meter standardized with wrong buffer
• Reagent contamination
• New reagent used without checking against old reagent
6. Instrument problems
• Slow clock used for a times reaction
• Recorder not properly warmed up; blank reading unstable
• Broken balance used to weigh out standards
7. Others
• Specimen left at room temperature by first shift technologist to be analyzed by second shift technologist ;
second technologist did not report for work and specimens were not analyzed until the next day
• Analyst calculated results mentally rather than drawing a standard curve or calculating a factor, the
results were grossly incorrect
• Initial computer print out was incorrect, and subsequent corrected print out was ignored

III. LIS (Laboratory Information System)

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• network of computers
• incorporate all aspects of the informational needs of laboratory and its customers
• from the intake of requests and processing of workflow to the delivery of results

COMPONENTS OF COMPUTER
1. hardware - physical components of the computer
• Input
• Output
• storage
2. software - instructions in human language into machine language

1. Information system - collection and integration of various pieces of hardware and software and the human
resources that meet data collection, storage, processing and report generations needs of an organization
2. Network - The set of interconnected computers that through hardware and software technology work
cooperatively for the purpose of information and application program exchange

IV. Safety Management

The practice of safety should be uppermost in the minds of all persons working in the laboratory.
The role of the individual
1. Must always be responsible for his/her safety
2. Must follow the rules and use equipment properly
3. Ensure that the workplace is safe
The role of the employer
1. Make sure that the employees have proper training, support, equipment, workload, resources and
environment
2. Ensure that the workplace is safe
Structural Requirements:
Safety factors should considered in the design and layout of the building
1. Entrance and exit route
2. Blockage of hallways and doors
3. Location of springklers and fire extinguishers
4. Storage of flammable materials
5. Ventilation system
The following must be considered in the floor plan layout and workplace design
1. Separate clinical and administrative offices from areas with hazardous materials
2. There should be a system in the delivery and storage of potentially hazardous materials
3. There should be a proper ventilation system
4. Accessibility of special safety equipment fume hoods and first aid stations
HAZARDS IN THE LABORATORY
I. Biological Hazards
II. Sharp Hazards
III. Chemical Hazards
IV. Radioactive Hazards
V. Electrical Hazards
VI. Fire/Explosive Hazards
VII. Physical Hazards
I. Biological Hazards
- infectious materials
- caused by microorganisms
- to prevent infection, one must how organisms are transmitted
Chain of Infection
1. Source – location of potentially harmful organism
Prevention:
- Handwashing
- Biohazardous waste disposal

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- Decontamination
2. Transmission
- direct contact
- inhalation of infected materials
- ingestion
Prevention:
- Handwashing
- Personal protective equipment
- aerosol prevention
- sterile equipment
3. Host
- becomes another source
Prevention:
- standard precaution
- immunization
- OSHA guidelines
- healthy lifestyle
Blood borne pathogens – any material that could possibly become contaminated with blood; must be
treated as having potential to carry a pathogen transmitted by blood
Methods of compliance / Protective Measure and Procedure
1. Adoption of universal precaution policy
2. Engineering and work practice controls
3. Personal protective equipment
4. Housekeeping techniques
Universal Precaution
• Barrier protection
• Gloves
• Face Protection
• Protective Body clothing
• Wash hands
• Avoid accidental injuries
• Proper disposal
Engineering and Work practice controls
1. There must be hand-washing facilities in the workplace
2. Eating, drinking, applying cosmetics are not allowed in the laboratory
PPE
1. Gloves
2. Eye and face protection
3. Protective body clothing
Housekeeping Technique
1. Maintain cleanliness in the worksite
2. Follow OSHA’s guidelines in cleaning and decontaminating work surfaces.
3. Follow guidelines in collection, storage and disposal of waste and sharps
Sharp Hazards
- needles, lancets, broken glassware
Possible injuries: cuts, puncture or blood borne exposure
Chemical Hazards
Right to know regulations
1. OSHA – the agency responsible for developing and enforcing regulations governing safety in the workplace.
2. Material Safety Data Sheets – a document required by OSHA detailing safety information about each hazardous
substance
Information included in an MSDS
a. Physical and mechanical characteristics
b. Fire and explosion potential
c. Reactivity potential
d. Health Hazards

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e. Methods for safe handling


Physical and Health Hazards
PHYSICAL HAZARDS – explosives, compressed gas, flammable
HEALTH HAZARDS - toxic agents, reproductive toxin, carcinogenic, hepatotoxin, nephrotoxin, neurotoxin
1. PPE – equipment such as eyeglasses, gloves, apron or full protective suits necessary to eliminate any hazards
2. Time weighted average – the level of exposure to a specific chemical agent that a worker may experience during
a normal 8-hour workday
3. Short term exposure limit – the maximum exposure a person may receive for a short period
4. Ceiling – the level above which no exposure is permitted at any time
Protective measure s to safeguard a person dealing with hazardous materials
1. Structural or building layout
2. Protective barriers or shield
3. Personal Protective equipment
4. Emergency and First aid supplies
Chemical spills
1. If there’s skin contact – flush the area with large amount of water
2. Remove contaminated clothing
Chemical Labeling
1. Poisonous
2. Corrosive
3. Carcinogenic
4. Flammable
Chemical Handling
a. Chemicals should never be mixed together
b. Chemicals should be added in the order specified in the instruction
c. Prepare reagents under fume hood
d. Do not pipet by mouth
Chemical Storage
The most important rule is to make sure that any chemicals or wastes stored together are compatible with
each other!
Never store the following types of wastes near each other:
• Acids and bases
• Organics and acids
• Cyanide, sulfide, or arsenic compounds and acids
• Alkali or Alkali earth metals, alkyllithiums etc. and aqueous waste
• Powdered or reactive metals and combustible materials
• Mercury or silver and ammonium containing compounds
RADIOACTIVE COMPOUNDS
- radioisotopes are used in the procedure
- the amount of radioactivity present in the laboratory is very small and not dangerous, however
the effects of radiation are cumulative related to the amount of exposure
- Person exposed to the radioactive hazards are required to wear a film badge.
Electrical Hazards
2 Major Hazards in the laboratory
1. Physical harm from shocks or burns when a person comes into contact with an electrical sources
2. Dangers from fire caused by heat and sparks generated by malfunctioning wiring or equipment
Recommended Safeguards from NFPA
1. Extension cords adapters should not be used
2. Equipment should not be operated with wet hands
3. Report dangerous conditions such as frayed cords and overloaded circuits to the appropriate persons
4. Circuit breakers should be labeled and conveniently located
5. Electrical equipment should not be used in areas with flammable materials
6. There should be a constant electrical safety checks
Recommended procedures in dealing with electrical accidents
1. Never directly touch a person who is in contact with a live wire or equipment
2. Unplug the electrical source

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3. Separate the victim from the live wire by using nonconductors like wood and plastic
4. Protect victim from clinical shock by covering him with coat until help arrives
FIRE/EXPLOSIVE HAZARDS
What to do in case of fire
Rescue – rescue anyone in immediate danger
Alarm – activate the institutional fire alarm system
Contain – close all doors and potentially affected areas
Extinguish – attempt to extinguish the fire, if possible
Fire Fighting Strategies
1. Construction
a. Building structure
b. Fire resistant construction material
c. Lay out plan for entrance and exits
d. Storage of flammable materials
Flammable chemicals should be stored in safety cabinets and explosion proof refrigerators. Gas cylinders
should be located away from heat
2. Fire Fighting Equipment
a. Fire resistant building materials
b. Automatic sprinklers
c. Self closing doors
d. Fire gydrants
e. Fire extinguisher
f. Fire blankets
g. Materials that can be used to prevent fire
Types of fire and fire extinguisher
CLASS FIRE TYPE / CATEGORY EXTINGUISHING MATERIAL

Class A Common combustible materials (wood, Water


paper, clothing)

Class B Flammable organic chemicals (gas, alcohol, Dry chemical, CO2


solvent)

Class C Electrical Dry chemical, CO2

Class D Combustible chemicals / metals Sand or dry powder

Class E Cannot be extinguished Dry chemicals

2. Training and practice


- orientation and service training
- Fire drills
VIII. Physical Hazards
General precaution
1. Avoid running in the workplace
2. Watch for wet floors
3. Keep long hair pulled back
4. Avoid dangling jewelry
5. Use closed-toe shoes
Management of safety Laboratory
A. Responsibility
Safety committee – assigned to overall development and monitoring of safety management program
Safety officer – in charge with the implementation and day-to-day management of the safety program
B. The safety management program

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(1) Policy and procedures


- all laboratories should have safety manuals
(2) Communications
- to make sure that the person working a hazardous substance has the information, proper training to
perform the job
(3) Disaster plan
- emergency plan should be established for fire evacuation and spills
(4) Safety audits and inspections
- safety inspection and drill should be conducted periodically
(5) Accident investigation and accident prevention
- there should be reporting system for accidents in lab
Safety equipment should be available in the laboratory – shower, eyewash fountains, fire extinguisher,
fume hood, fire alarm

The following items should be available.


- first aid kit, chemical spill control kit, fire blankets, safety goggles, face shields, gloves.
Laboratory Safety Management
SOLID WASTE
- any solid, liquid, semi-solid or contained gaseous material that is discarded, abandoned, recycled, or is
an inherently waste-like material
Non-hazardous wastes
- are those that pose no immediate threat to human health and the environment
ex. Household garbage
Biodegradable waste – originates from plant or animal sources, which may be broken down by other living
organisms
Non-biodegradable – cannot be broken down by other living organisms
Hazardous waste – pose potential threat to human health or the environment when improperly treated, stored,
transported and disposed.
1. Ignitability
a. Liquids w/ flash point below 60 degC
b. Cause fire through friction, absorption of moisture or spontaneous chemical changes
c. Ignitable compressed gasses
d. Oxidizers
2. Corrosivity
- pH < 2 or 12.5
- liquid that will corrode steel faster than ¼ inch a year
3. Reactivity
- reacts violently with water
- capable of undergoing violent chemical change
- Ex. Alkali metals, peroxides, cyanide, & sulfide
4. Toxicity
- solid waste whose leachate contains any of the toxic heavy metals, pesticides or organics in
concentration equal to or greater than the regulatory level
- Ex. Benzene, chloroform, lead
Special Waste
- any solid waste that is not regulated as hazardous but requires special handling and disposal to protect
human health and environment
- they are regulated with specific guidelines
1. Biological medical waste
2. Petroleum products – oil
3. Light ballasts
4. Asbestos
5. Lead acid & nickel/ cadmium batteries
6. Radioactive

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Medical Waste
• Any solid waste that is generated in the diagnosis, treatment, or immunization of human beings or animals
• blood-soaked bandages
• Culture dishes and other glassware
• discarded surgical gloves/ surgical instruments
• Discarded needles used to give shots or draw blood
• Cultures, stocks, swabs used to inoculate cultures
• Removed body organs
• Discarded lancets
Proper Disposal of Laboratory Waste
Laboratory Wastes
1. Chemical waste –
A. If the chemical waste is not hazardous – dispose in trash or in sink
B. Regulated hazardous waste
1. If the waste can be neutralized or destroyed neutralize first, then dispose in the sink
2. If the can not be neutralized – collect in hazardous waste containers, then contact licensed disposal company
3. Radioactive Waste
A. If the half life of the radioactive waste is < 90 days
- decay in storage
- dispose in trash or in sink
B. Half life - > 90 days
- contact licensed disposal company
3. Biological Waste
A. Sharps – contact licensed disposal company
B. Animal carcasses – should be incinerated
C. Infectious waste – blood, blood products, pathology waste products and microbiological waste.
- should be autoclaved or incinerated before the waste is disposed in color coded container with
biohazard symbol, or in sink

DIAMOND LABEL (NFPA 704)

• BLUE-biohazard/health hazard
• RED- flammables
• YELLOW- reactive
• WHITE- other information about the substance

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