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MTLBE 4 5 Flashcards

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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
Clinical laboratories conducting mobile collection are required to secure a _______________________________
Remote Collection Permit for Clinical Laboratory or RCP CL
26
is a diagnostic test at or near the site of patient care rather than in the clinical laboratory
Point of Care Testing
27
Every clinical laboratory must be headed by a ___________________, certified either as a _________________, an _____________________, or both by the _____________________
pathologist, clinical pathologist, anatomic pathologist, Philippine Board of Pathology
28
A single laboratory test is estimated to be processed within _____
10 mins
29
Manual testing; __tests/RMT/ 8hours
50
30
Manual testing; __tests/RMT/ 12hours
75
31
Automated testing; __tests/RMT/ 8hours
100
32
Automated testing; __tests/RMT/ 12hours
150
33
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
HFSRB, Center for Health Development (CHD)
34
is a laboratory in a government hospital which has been designated by the DOH to provide special functions and services for specific disease areas
National Reference Laboratory
35
Anatomic pathology for cardiac diseases.
Philippine National Heart Center (PNHC)
36
Hematology, coagulation tests, immunopathology, and urinalysis for renal diseases.
National Kidney and Transplant Institute (NKTI)
37
Clinical chemistry and pathology for pulmonary diseases.
Lung Center of the Philippines (LCP)
38
HIV, syphilis, hepatitis B, and hepatitis C tests.
STD/AIDS Cooperative Central Laboratory (SACCL)/San Lazaro Hospital (SLH)
39
Testing for tropical and infectious diseases like dengue, tuberculosis, malaria, and rabies.
Research Institute for Tropical Medicine (RITM)
40
Confirmatory drug tests, water testing, and toxicology.
East Avenue Medical Center (EAMC)
41
Only a _________ and a registered _________________ are authorized to sign official laboratory reports.
pathologist, medical technologist (RMT)
42
_____________ are considered consultations from the physician to the pathologist, and the resulting report serves as the official consultation report.
Laboratory requests
43
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.
Secretary of Health
44
Anyone violating R.A. No. 4688 or its rules may face imprisonment from _______________________, a fine between __________________________________, or both, as decided by the court.
not less than one month to not more than one year, not less than one thousand and not more than five thousand pesos
45
The ____________________________________ or the___________________________________ or their representatives will investigate complaints against a clinical laboratory.
Health Facilities and Services Regulatory Bureau (HFSRB) , CHD Director (Center for Health Development)
46
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.
CHD Director
47
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 _____________________
10, final and binding
48
Approved on August 22, 2007 “Revised Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories” The current implementing rule of RA 4688
AO No. 2007-0027
49
Handles specimen collection and handling
Pre-Analytical Processes
50
Deals with reporting the results and disposal of the waste products
Post-Analytical Processes
51
Encompasses testing procedures, instrumentation, equipment, reagents, quality control, personnel and facilities
Analytical Processes
52
order mandating the minimum technical working area of laboratories
Department Memorandum No. 148 s. 2003
53
Requires a minimum technical working area of at least 10 square meters
Primary Clinical Laboratory
54
Requires a minimum technical working area of at least 20 square meters
Secondary Clinical Laboratory
55
Requires a minimum technical working area of at least 60 square meters
Tertiary Clinical Laboratory
56
schedule for application for NCR
Jan to Mar
57
schedule for application for region 1, 2, 3, and CAR
Feb to Apr
58
schedule for application for region 4, 5, 6
March to May
59
schedule for application for region 7, 8 ,9
Apr to Jun
60
schedule for application for region 10, 11, 12, CARAGA, and ARMM
May to July
61
An analytical test performed outside the laboratory by healthcare providers
POINT OF CARE TESTING (POCT)
62
National Blood Services Act of 1994
Republic Act No. 7719
63
NATIONAL BLOOD SERVICES ACT OF 1994 Enacted into Law :
April 2, 1994
64
refers to the human blood used transfusion
Blood
65
Include whole blood, packed red blood cells, granulocytes, platelets,
Blood Products
66
Blood collected within 24 hours; stored in a blood plasma component of donor blood.
Fresh Whole Blood (FWB)
67
Also known as red cell concentrate; separated by gravity or centrifugation; stored at +2°C to +6°C
Packed Red Blood Cells
68
Red cells washed with 0.9% sterile isotonic saline; depleted of plasma, platelets, and leukocytes
Washed Red Cells
69
Made from granulocytes collected through apheresis.
Granulocyte Concentrate
70
Red cells with most plasma and leukocytes removed using a third-generation filter.
Leukocyte-Depleted Red Cell:
71
Also called random donor platelets; stored at +20°C to +24°C with continuous agitation; derived from whole blood.
Platelet Concentrate
72
Contains cryoglobulin fraction; prepared by further processing FFP; refrozen within one hour after preparation.
Cryoprecipitate
73
Also known as cryo-poor plasma; supernate plasma removed during cryoprecipitate preparation; contains most clotting factors
Cryosupernate
74
Non-cellular fluid portion of blood; separated within six to eight hours of collection; rapidly frozen and maintained
Fresh Frozen Plasma (FFP)
75
Operated and maintained by national, local government, or other government agencies
Government BSFs
76
Operated and maintained by national, local government, or other government agencies.
Government BSFs
77
Owned, established, and operated by individuals, corporations, associations, or organizations.
Private BSFs
78
These facilities are located within a hospital. They usually serve patients directly through the hospital's blood transfusion service
Hospital-based BSFs
79
These can be either government-owned or privately owned, and they are located outside the premises of a
Non-hospital-based BSF
80
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.
Blood Station (BS)
81
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.
Blood Collection Unit (BCU)
82
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
Blood Bank (BB)
83
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.
Blood Bank and other investors (BB)
84
What are the transfusion transmissible infections (TTIs) screened by BCs?
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
Testing of TTIs are done only in ________
Blood Centers
86
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
R.A. 11166, Philippine HIV and AIDS Policy Act of 2018
87
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
physician
88
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.
physician
89
Hospital-based blood stations managed and supervised by a _________________
pathologist
90
A Blood Service Facility must have at least ___ MedTech for every shift
1
91
An official permit issued by the DOH to an individual, corporation, partnership, or association to a BCU or BS
Authority to Operate (ATO)
92
a formal authority issued by the DOH to an individual, corporation, partnership, or association to a BB or BC
License to Operate (LTO)
93
RA 7719 was approved on
on May 15, 1994 by President Fidel V. Ramos

2C MIDTERMS (14 decks)

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