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2C MIDTERMS > MTLBE 4 5 > Flashcards

MTLBE 4 5 Flashcards

1
Q

Clinical laboratories are regulated by the _________________________________

A

Department of Health

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2
Q

is the law regulating the operation and maintenance of clinical laboratories and requiring the registration of the same with the DOH, through the HFSRB

A

RA 4688

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3
Q

is a facility where tests are done on specimens taken form the human body to obtain information about the health status of a patient for the prevention, diagnosis, and treatment of diseases

A

Clinical Laboratory

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4
Q

labs that are operated and maintained, partially or wholly, by the national government, local government unit, or any other political unit or any department, division, board, or agency

A

GOVERNMENT CLINICAL LABORATORIES

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5
Q

owned, established, and operated by an individual, corporation, association, or organization

A

PRIVATE CLINICAL LABORATORIES

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6
Q

include Clin chem, Hema, immunohema, Microbio, Immuno, Clin mic, and other tests

A

Clinical Pathology

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7
Q

includes surgical pathology, immunohistopathology, cytology, autopsy, forensic pathology and molecular pathology

A

Anatomic Pathology

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8
Q

Clin Lab according to ownership

A

government and private clin lab

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9
Q

Clin Lab according to function

A

Clinical Pathology and Anatomic Pathology

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10
Q

Clin Lab according to Institutional Character

A

Institution based clinical lab and Freestanding Laboratories

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11
Q

are those that operate with the premises and as part of an institution, such as but not limited to a hospital, medical clinic, school, medical facility for overseas workers and seafarers, birthing home, psychiatric facility, drug rehabilitation

A

Institution-based Clinical Laboratory

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12
Q

are those that are not part of any institution

A

Freestanding Laboratories

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13
Q

laboratories that offer basic and routine laboratory examinations

A

General Clinical Laboratories

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14
Q

refers to a clin lab that offers the following minimum service capabilities:
Routine Hematology, Qualitative platelet determination, Routine Urinalysis, Routine Fecalysis, Blood typing

A

PRIMARY CATEGORY

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15
Q

refers to a clin lab that offers the following minimum service capabilities:
Routine Clinical Chemistry, Quantitative platelet determination, Cross-matching (for hosp), Gram Staining (for hosp), KOH (for hosp)

A

SECONDARY CATEGORY

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16
Q

refers to a clin lab that offers the following minimum service capabilities:
Special chemistry, Special hematology, Immunology, Microbiology

A

TERTIARY CATEGORY

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17
Q

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

A

Limited Service Capability

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18
Q

offer highly specialized laboratory services that are usually not provided by a general clinical laboratory, These services include: Assisted reproduction technology, Molecular and cellular technology, molecular biology, molecular pathology, forensic pathology, anatomic pathology

A

Special Clinical Laboratories

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19
Q

Is a document issued by the DOH to an individual, agency, partnership, or a corporation that operates clinical laboratory upon compliance with the requirements set forth by the law.

A

License, or License to Operate (LTO)

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20
Q

Laboratories exempted from taking a license and registration

A

malarial screening, Acid-fast bacilli microscopy, test for STI, Cervical cancer screening using PAP smears

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21
Q

LTO is valid for _____ year and must be renewed _________

A

1 year, annually

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22
Q

mobile clinical laboratory are allowed to operate within ______ radius from its main laboratory only

A

100kms

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23
Q

is an individual doctor’s office/clinic wherein laboratory examinations are performed

A

Physician’s Office Laboratory

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24
Q

is a specialized facility that moves from one testing site to another or has a temporary testing location

A

Mobile Clinical Laboratory testing unit

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25
Q

Clinical laboratories conducting mobile collection are required to secure a _______________________________

A

Remote Collection Permit for Clinical Laboratory or RCP CL

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26
Q

is a diagnostic test at or near the site of patient care rather than in the clinical laboratory

A

Point of Care Testing

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27
Q

Every clinical laboratory must be headed by a ___________________, certified either as a _________________, an _____________________, or both by the _____________________

A

pathologist, clinical pathologist, anatomic pathologist, Philippine Board of Pathology

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28
Q

A single laboratory test is estimated to be processed within _____

A

10 mins

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29
Q

Manual testing; __tests/RMT/ 8hours

A

50

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30
Q

Manual testing; __tests/RMT/ 12hours

A

75

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31
Q

Automated testing; __tests/RMT/ 8hours

A

100

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32
Q

Automated testing; __tests/RMT/ 12hours

A

150

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33
Q

The application for registration and issuance of an LTO is filed with the ______ or through the _____________ of the DOH that has the jurisdiction over the existing or proposed clinical laboratory

A

HFSRB, Center for Health Development (CHD)

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34
Q

is a laboratory in a government hospital which has been designated by the DOH to provide special functions and services for specific disease areas

A

National Reference Laboratory

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35
Q

Anatomic pathology for cardiac diseases.

A

Philippine National Heart Center (PNHC)

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36
Q

Hematology, coagulation tests, immunopathology, and urinalysis for renal diseases.

A

National Kidney and Transplant Institute (NKTI)

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37
Q

Clinical chemistry and pathology for pulmonary diseases.

A

Lung Center of the Philippines (LCP)

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38
Q

HIV, syphilis, hepatitis B, and hepatitis C tests.

A

STD/AIDS Cooperative Central Laboratory (SACCL)/San Lazaro Hospital (SLH)

39
Q

Testing for tropical and infectious diseases like dengue, tuberculosis, malaria, and rabies.

A

Research Institute for Tropical Medicine (RITM)

40
Q

Confirmatory drug tests, water testing, and toxicology.

A

East Avenue Medical Center (EAMC)

41
Q

Only a _________ and a registered _________________ are authorized to sign official laboratory reports.

A

pathologist, medical technologist (RMT)

42
Q

_____________ are considered consultations from the physician to the pathologist, and the resulting report serves as the official consultation report.

A

Laboratory requests

43
Q

The ____________________, through the HFSRB (Health Facilities and Services Regulatory Bureau), is responsible for enforcing the clinical laboratory law and can issue necessary rules and regulations.

A

Secretary of Health

44
Q

Anyone violating R.A. No. 4688 or its rules may face imprisonment from _______________________, a fine between __________________________________, or both, as decided by the court.

A

not less than one month to not more than one year, not less than one thousand and not more than five thousand pesos

45
Q

The ____________________________________ or the___________________________________ or their representatives will investigate complaints against a clinical laboratory.

A

Health Facilities and Services Regulatory Bureau (HFSRB) , CHD Director (Center for Health Development)

46
Q

After investigation, if a laboratory or its staff are found guilty of violating R.A. 4688 or its rules, the ___________________ may suspend, cancel, or revoke its License to Operate (LTO) and may also seek law enforcement assistance to close the laboratory, without barring further criminal charges.

A

CHD Director

47
Q

Decisions made by the HFSRB/CHD can be appealed to the Office of the Health Secretary within ___ days of receiving the decision notice.
The HFSRB will provide the decision, along with relevant documents and transcripts, for review. The decision of the Health Secretary is _____________________

A

10, final and binding

48
Q

Approved on August 22, 2007
“Revised Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories”
The current implementing rule of RA 4688

A

AO No. 2007-0027

49
Q

Handles specimen collection and handling

A

Pre-Analytical Processes

50
Q

Deals with reporting the results and disposal of the waste products

A

Post-Analytical Processes

51
Q

Encompasses testing procedures, instrumentation, equipment, reagents, quality control, personnel and facilities

A

Analytical Processes

52
Q

order mandating the minimum technical working area of laboratories

A

Department Memorandum No. 148 s. 2003

53
Q

Requires a minimum technical working area of at least 10 square meters

A

Primary Clinical Laboratory

54
Q

Requires a minimum technical working area of at least 20 square meters

A

Secondary Clinical Laboratory

55
Q

Requires a minimum technical working area of at least 60 square meters

A

Tertiary Clinical Laboratory

56
Q

schedule for application for NCR

A

Jan to Mar

57
Q

schedule for application for region 1, 2, 3, and CAR

A

Feb to Apr

58
Q

schedule for application for region 4, 5, 6

A

March to May

59
Q

schedule for application for region 7, 8 ,9

A

Apr to Jun

60
Q

schedule for application for region 10, 11, 12, CARAGA, and ARMM

A

May to July

61
Q

An analytical test performed outside the laboratory by healthcare providers

A

POINT OF CARE TESTING
(POCT)

62
Q

National Blood Services Act of 1994

A

Republic Act No. 7719

63
Q

NATIONAL BLOOD SERVICES ACT OF 1994
Enacted into Law :

A

April 2, 1994

64
Q

refers to the human blood used transfusion

A

Blood

65
Q

Include whole blood, packed red blood cells, granulocytes,
platelets,

A

Blood Products

66
Q

Blood collected within 24 hours; stored in a blood
plasma component of donor blood.

A

Fresh Whole Blood (FWB)

67
Q

Also known as red cell concentrate; separated by
gravity or centrifugation; stored at +2°C to +6°C

A

Packed Red Blood Cells

68
Q

Red cells washed with 0.9% sterile isotonic saline; depleted
of plasma, platelets, and leukocytes

A

Washed Red Cells

69
Q

Made from granulocytes collected through
apheresis.

A

Granulocyte Concentrate

70
Q

Red cells with most plasma and leukocytes
removed using a third-generation filter.

A

Leukocyte-Depleted Red Cell:

71
Q

Also called random donor platelets; stored at +20°C to
+24°C with continuous agitation; derived from whole blood.

A

Platelet Concentrate

72
Q

Contains cryoglobulin fraction; prepared by further
processing FFP; refrozen within one hour after preparation.

A

Cryoprecipitate

73
Q

Also known as cryo-poor plasma; supernate plasma removed
during cryoprecipitate preparation; contains most clotting factors

A

Cryosupernate

74
Q

Non-cellular fluid portion of blood; separated
within six to eight hours of collection; rapidly frozen and maintained

A

Fresh Frozen Plasma (FFP)

75
Q

Operated and maintained
by national, local
government, or other
government agencies

A

Government BSFs

76
Q

Operated and maintained
by national, local
government, or other
government agencies.

A

Government BSFs

77
Q

Owned, established,
and operated by
individuals,
corporations,
associations, or
organizations.

A

Private
BSFs

78
Q

These facilities are located
within a hospital. They
usually serve patients
directly through the
hospital’s blood
transfusion service

A

Hospital-based
BSFs

79
Q

These can be either
government-owned or
privately owned, and
they are located outside
the premises of a

A

Non-hospital-based
BSF

80
Q

Provides basic blood services, including:
Advocacy and promotion of voluntary blood donation.
Provision of blood products: Whole blood and packed
red cells.
Storage, issuance, transport, and distribution of whole
blood and blood components.
Compatibility testing of blood (if hospital-based),
ensuring safe transfusions.

A

Blood Station (BS)

81
Q

Focuses on blood collection and donor management, including:
Advocacy and promotion of voluntary blood donation.
Recruitment, retention, and care of voluntary blood donors.
Screening and selection of donors to ensure safety.
Health education and counseling services related to blood
donation.
Collection of blood through mobile or facility-based units from
qualified voluntary donors.

A

Blood Collection Unit (BCU)

82
Q

a. Advocacy and Promotion of voluntary blood donation and a
healthy lifestyle.
b. Storage and issuance of whole blood and blood components
obtained from a BC.
c. The following services shall also be provided:
Compatibility testing of red cell units
Direct Coombs test
Red cell antibody screening
Investigation of transfusion reactions
Assist the Hospital Blood Transfusion Committee (HBCT) in the
conduct of post-transfusion surveillance, or hemovigilance

A

Blood Bank (BB)

83
Q

managed and supervised by a pathologist certified as such by Philippine
Board of Pathology or by a hematologist certified as such by the
Philippine Board of Hematology, and with experience in a blood service
facility.

A

Blood Bank and other investors (BB)

84
Q

What are the transfusion transmissible infections (TTIs)
screened by BCs?

A
  1. Human immunodeficiency virus (HIV) (determination of anti-HIV 1/2)
  2. Hepatitis B (determination of HBsAg)
  3. Hepatitis C (determination of anti-HCV)
  4. Malaria
  5. Syphilis
85
Q

Testing of TTIs are done only in ________

A

Blood Centers

86
Q

under ___________________________, otherwise known as the __________________________________, a second testing for HIV may be requested by a recipient of a blood unit as a matter of right

A

R.A. 11166, Philippine HIV and AIDS Policy Act of 2018

87
Q

Non-hospital-based blood stations managed and supervised by __________ with at least three months formal training in basic blood banking provided by a DOH recognized training provider

A

physician

88
Q

Non-hospital-based BCUs, and BS/BCUs managed and supervised by a ________________ with formal training in basic blood banking provided by a DOH-recognized training provider.

A

physician

89
Q

Hospital-based blood stations managed and supervised by a _________________

A

pathologist

90
Q

A Blood Service Facility must have at least ___ MedTech for every shift

A

1

91
Q

An official permit issued by
the DOH to an individual,
corporation, partnership, or
association to a BCU or BS

A

Authority to Operate (ATO)

92
Q

a formal authority issued
by the DOH to an
individual, corporation,
partnership, or
association to a BB or BC

A

License to
Operate (LTO)

93
Q

RA 7719 was approved on

A

on May 15, 1994 by President Fidel V. Ramos

2C MIDTERMS (14 decks)

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