MTLAWS pt.1 [Midterms]

Clinical Laboratory Act, National Blood Services Act, Blood Bank laws

June 18, 1966

when was Clinical Laboratory Act of 1966 approved

RA 4688

The Clinical Laboratory Act of 1966

The Clinical Laboratory Act of 1966

An act regulating the operation and maintenance of Clinical Laboratories and requiring the registration of the same with the Department of Health, providing penalty for the violation thereof and for other purposes.

AO No. 2007-0027

Revised rules and regulations governing the registration, operation, and maintenance of clinical laboratories in the Philippines

10

How many days to make an appeal of decisions in the office of DOH Sec

August 22, 2007

when was AO 2007-0027 implemented

Bureau of Health Facilities and Services

where does the LTO of clinical laboratories applied thru

October 1 to November 30

when can non-hospital based labs apply for renewal

• name of lab

• bear name and signature of RMT and pathologist

ano dapat nilalaman ng reports ng lab

AO No 2005-0027

Rules and regulations governing the regulation of HIV laboratories

August 15, 2005

when was AO 2005-0027 implemented

AO 2007-0027 (A)

exemption of National Tuberculosis Reference Laboratory and Regional TB Ref Labs from licensing

August 28, 2008

when was AO 2007-0027 (A) implemented

San Lazaro Hospital

what is the name of the hospital for the NRL of HIV/AIDS

AO 393-E s. 2000

Designation of National Reference Laboratories (NRL)

November 14, 2000

when was AO 393-E s. 2000 implemented

Research Institute for Tropical Medicine (Muntinlupa)

national reference laboratory

bacteria, parasite, fungi, virus; national reference laboratory for confirmatory testing of blood units

STD/AIDS Cooperative Central Laboratory (Santa Cruz)

national reference laboratory

HIV/AIDS, Hepatitis, SY and other STIs

East Avenue Medical Center (Quezon City)

national reference laboratory

Environmental & OccupationalHealth, Toxicology & Micronutrient Assay

National Kidney and Transplant Institute (Quezon City)

national reference laboratory
Hematology including Immunohematology, Immunopathology and Anatomic Pathology

Lung Center of the Philippines (Quezon City)

national reference laboratory
Chemistry

Department Memorandum 2009-0086

Implementation of external quality assessment program as regulatory requirement for licensing of clinical laboratories

AO 274 s. 1976

Designated to support the primary objective of health laboratory services of the Department of Health

AO 48 s. 2003

Third classification of clinical laboratories (institutional character)

February 3, 2009

when was Department Memorandum 2009-0086 implemented?

Hematology

Proficiency testing areas:
primary, secondary & tertiary clinical labs

Clinical Chemistry

Proficiency testing areas:

tertiary clinical labs

HIV/AIDS, Hepa B & C

Proficiency testing areas:
all labs with such tests

Water proficiency testing

Proficiency testing areas:
all screening & confirmatory water testing labs

Drug proficiency testing

Proficiency testing areas:
screening & confirmatory DTLs

• AFB microscopy

• cervical cancer screening

• malaria screening

what laboratory examinations are excluded in government laboratories and considered as an extension of licensed government clinical lab instead

Critical values

panic values that needs for some corrective action

Inspection Tool

checklist used by regulatory officer

License

document issued by DOH to applicant upon compliance

Mobile Clinical Laboratory

moves from testing site but affiliated with base lab

Physician Office Laboratory

what is the meaning of POL

Center for Health Development

what is the meaning of CHD

Satellite Testing Site

any testing site that performs lab exams outside the physical confines of the base lab

STAT Tests

urgent tests and to be released within one hour after procedure

Routine Test

basic, commonly requested tests

Monitoring Examinations

series of tests on patients

Point of Care Testing

testing at or near the site of the patient

• Routine hematology (CBC) – Hb, Hct, WBC& Differential count

• Qualitative platelet determination

• Routine urinalysis

• Routine fecalysis

• Blood typing (Hospital-based)

mga test sa primary clinical laboratory

• Routine clinical chemistry – includes blood glucose, BUN, BUA, Crea &total cholesterol

• Quantitative platelet determination

• Cross matching (Hospital-based)

• Gram staining (hospital based)

• KOH (hospital based)

mga test sa secondary clinical laboratory

• special chemistry

• special hematology

• immunology/serology

• Microbiology (C/S)

• Limited Service Capability

mga test sa tertiary clinical laboratory

• Assisted Reproduction Technology Labs

• Molecular and Cellular Technology

• Molecular Biology

• Molecular Pathology

• Forensic Pathology

• Anatomic Pathology

mga test sa special clinical laboratory

Clinical labs operated and maintained for research and teaching purposes

what kind of lab are exempted but needs to be registered with Bureau of Health Facilities and Services

Special clinical labs

what kind of clinical labs are required to register with Bureau of Health Facilities and Services without being licensed

National Reference Laboratory

what laboratory is designated by DOH and shall be covered by license of the clinical lab of the hospital

Physician Office Laboratory

what laboratory requires license if doing any or all of the following:

• issue official lab results

• perform more than monitoring exams

• cater not only to physician’s own patients

• capability to perform HIV testing

• drinking water analysis

what are the two things that shall be specifically indicated in the LTO

within 100 kms radius

gano kalayo lang pwede kolektahing specimen ng mobile labs

Hospital-based

• processed under the One-Stop-Shop Licensure System for Hospitals

Non-hospital based

beginning first day of October until end of November of current year (discount on renewal fee)

• Failure to submit duly accomplished form

• Payment of proper fee on or before expiration date

grounds for the automatic cancellation of LTO

• imprisonment not less than 1 month

• fine P1,000-P5,000

• IF a corporation or managing head or owner is liable

penalty in violating RA 4688

Clinical centrifuge

Hemacytometer

Microhematocrit centrifuge

Microscope with OIL

Hemoglobinometer or equivalent

Differential counter or equivalent

Equipment/Instruments in a primary clinical laboratory

Refrigerator

Photometer or its equivalent

Waterbath or its equivalent

Timer or its equivalent

Equipment/Instruments in a secondary clinical laboratory

Incubator

Balance

Rotator

Serofuge or its equivalent

Autoclave

Drying oven

Biosafety cabinet (BSC) or equivalent

Equipment/Instruments in a tertiary clinical laboratory

Refusal to participate in EQAS-NRL

one of the basis for suspension/revocation of license

FALSE

TRUE OR FALSE

Anatomic and forensic pathology reports are kept for at least 1 year only

RA 7719 - National Blood Services Act of 1994

what law is an act promoting voluntary blood donation and regulating blood banks

RA 7719

National Blood Services Act of 1994

Blood/ Blood Product

Human blood, processed or unprocessed.

Blood Bank

Institution responsible for collecting, processing, and storing blood.

Commercial Blood Bank

A blood bank operating for profit (to be phased out)

Hospital-based blood bank

blood bank within a hospital, performing compatibility testing

Voluntary blood donor

an individual donating blood without monetary compensation

National Voluntary Blood Services Program

• A nationwide program implemented by DOH, PNRC, PBCC.

• Funded by the Government, PCSO, PAGCOR, Duty-Free Philippines, and private donors.

• Aims to ensure an adequate and safe blood supply for all regions.

Within 2 years

how long should the commercial blood banks to be phased out

licensed physicians

who manages blood banks

• Blood bags

• Testing reagents

• Blood screening and storage equipment.

Blood banks and hospitals under NVBSP can import tax-free:

FALSE

TRUR OR FALSE

DOH did not set maximum allowable fees for blood processing

• overcharging for blood

• operating a blood bank without a license

• Transfusing contaminated blood

what are the violations under RA 7719

• suspension or revocation of license

• fine of P5,000-P50,000

• imprisonment of 1-6 months

what are the possible penalties for overcharging for blood

• fine of P50,000 to P500,000

• imprisonment of 12-20 years

what are the possible penalties for operating a blood bank without a license

• 10 years imprisonment

• additional criminal charges under the Revised Penal Code

what are the possible penalties for transfusing contaminated blood

RA 1517 Blood Bank Act

what is the repealing clause/act of RA 7719 National Blood Services Act of 1994

May 15, 1994

when was RA 7719 signed into law

President Fidel V. Ramos

who signed RA 7719 into law

• RA 7719 (National Blood Services Act of 1994)

• RA 1517 (Regulating the Collection, Processing, and Sale of Human Blood)

what laws regulates the utilization, transfer, and processing of blood in the Philippines

• Philippine National Red Cross

• Philippine Blood Coordinating Council

what are the two key organizations in National Blood Services

Apolinario Mabini

who founded the National Association of The Red Cross

February 17, 1899

when was National Association of the Red Cross founded

Manuel Quezon

The Philippine Red Cross was recognized during the administration of _______

1900

when was Filipino Red Cross Society Recognized

Dr. Horacio Yanzon

who is the first filipino Red Cross manager

RA 95

what law is signed by President Manuel Roxas making Mrs. Aurora Aragon Quezon the chairman

Mrs. Aurora Aragon Quezon

who is the chairman mentioned in RA 95

RA 10072

what RA is signed by President Gloria Macapagal Arroyo

Philippine Red Cross

a non-profit humanitarian organization which provides the following services:

• Blood Services

• Disaster Management

• Safety, Health & Social Services

• Red Cross Youth & Volunteer Services

Philippine Blood Coordinating Council

• A multi-sectoral organization promoting voluntary blood donation.

• Ensures safe, quality blood for transfusion.

• Advocates for rational use of blood products.

• Improves blood banking procedures and policies.

• Encourages international collaboration in blood banking and transfusion.

RA 1517

Regulates collection, processing, and sale of human blood.

AO No. 36 (1994)

what administrative order implements RA 7719

AO No. 1 (1995)

what administrative order establishes National Voluntary Blood Services Unit (NVBSU).

AO No. 17-A (1998)

what administrative order is responsible for licensing requirements for blood banks.

AO No. 2010-0001

what administrative order is the Guidelines for Philippine National Blood Services.

• Blood Station (BS)

• Blood Collection Unit (BCU)

• Blood Bank Center (BBC)

Classifications of Blood Service Facilities in terms of by service capability

Blood Station

• Collect blood donations from voluntary donors.

• Ensures proper handling, labeling, and storage of collected blood.

• Conducts basic testing such as blood typing and screening for infectious diseases.

• Distributes stored blood to hospitals and higher-level blood banks.

Blood Collection Unit

• Responsible for collecting blood donations from voluntary donors. (pareho lang sa BS)

• Educates potential donors about blood donation benefits.

• Conducts blood typing and screening for infectious diseases. (pareho lang sa BS)

• Coordinates with higher-level blood banks for further processing and distribution.