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MTLB211 > Week 4: The Clinical Laboratory And Its Law > Flashcards

Week 4: The Clinical Laboratory And Its Law Flashcards

1
Q

Also known as Clinical Laboratory Act of 1966

A

REPUBLIC ACT NO. 4688

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2
Q

When was RA no.4688 created?

A

June 18, 1966

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3
Q

AN ACT REGULATING THE OPERATION AND
MAINTENANCE OF CLINICAL LABORATORIES AND REQUIRING THE REGUSTRATION OF THE SAME WITH THE DEPARTMENTS OF HEALTH, PROVIDING PENALTY AND VIOLATION THEREOF, AND FOR OTHER PURPOSES

A

REPUBLIC ACT NO. 4688/CLINICAL LABORATORY
ACT OF 1966

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4
Q

A type of classification of clinical laboratories based on the roles or image projected by the clients.

A

CLASSIFICATION BASED ON SERVICE CAPACITY

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5
Q

Working are for medical technologist

A

CLINICAL LABORATORY

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6
Q

Clinical laboratory practitioner

A

CLINICAL LABORATORY STAFF

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7
Q

One of the inherent qualities of a registered medical technologist who is working in a clinical laboratory

A

COMPENTENCY

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8
Q

An act regulating the operation and maintenance of clinical laboratories and requiring registration of the same with the Department of Health

A

REPUBLIC ACT NO. 4688

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9
Q

UNDER WHAT ADMINISTRATIVE ORDER NO. OF THE REVISED RULES AND REGULATIONS GOVERNING THE LICENSING AND REGULATION OF LABORATORIES IN THE PHILIPPINES, CAN CLINICAL LABORATORIES BE CLASSIFIED BASED ON?

A

ADMINISTRATIVE ORDER NO. 2007-0027

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10
Q

Give the 4 classification of clinical laboratories

A
  1. BASED ON OWNERSHIP
  2. BASED ON FUNCTION
  3. BASED ON INSTITUTIONAL CHARACTER
  4. BASED ON SERVICE CAPACITY
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11
Q
  • Clinical laboratories may be considered GOVERNMENT-OWNED or PRIVATE.
  • Government owned laboratories are those which are maintained, partially or wholly, by either the national or local government.
  • Private laboratories are established, operated, and maintained by individual, corporation, or association without any affinity with the government.
A

BASED ON OWNERSHIP

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12
Q

2 types of Laboratory Based on Function

A

CLINICAL PATHOLOGY FUNCTION and ANATOMIC PATHOLOGY FUNCTION

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13
Q

clinical chemistry, hematology, immunohematology, microbiology, immunology, clinical microscopy, serology, endocrinology, molecular biology, cytogenetic, toxicology, and therapeutic drug monitoring.

A

CLINICAL PATHOLOGY FUNCTION

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14
Q

surgical, immunology, histopathologic cytologic, autopsy procedure, forensic, and molecular pathologic techniques

A

ANATOMIC PATHOLOGY FUNCTION

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15
Q

Institute based clinical laboratory and Free-standing laboratory

A

BASED ON INSTITUTIONAL CHARACTER

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16
Q

This clinical laboratory operates within the premises and as part of institution such as hospital, clinic, school, or medical facility. E.g. Department of Pathology of the National Kidney and Transplant Institute.

A

Institute based clinical laboratory

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17
Q

Has no affinity with any other institution. For instances, the Hi-Precision Diagnostic laboratory is considered free-standing

A

Free-standing laboratory

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18
Q

Primary, Secondary, Tertiary and Limited-service capability

A

BASED ON SERVICE CAPABILITY

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19
Q

– provides the following minimum service capabilities:
I. Routine Hematology: CBC
II. Qualitative Platelet Determination
III. Routine Urinalysis, Fecalysis
IV. Blood typing – Hospital-based

A

Primary Category

20
Q
  • provides the following minimum service
    capabilities of primary lab + the ff:
    I. Routine Clinical Chemistry
    II. Quantitative Platelet Determination
    III. Cross matching, Gram Staining, KOH - Hospital-based
A

Secondary Category

21
Q

provides the following minimum service capabilities of secondary lab + the ff:
I. Special chemistry
II. Special hematology, including coagulation procedures
III. Immunology
IV. Microbiology – culture and sensitivity
● Aerobic and Anaerobic – hospital-based
● Aerobic or Anaerobic – non-hospital-based

A

Tertiary Category

22
Q

provides lab test required for a particular service in institutions such as but not limited to, dialysis center & hygiene clinics

A

Limited-service capability (institution-based)

23
Q

A laboratory that offers highly specialized laboratory services that are usually not provided by a general clinical laboratory.

A

BASED ON SERVICE CAPABILITY (SPECIALIZED CLINICAL LABORATORY)

24
Q
  • Handle organisms that are unlikely to cause human diseases.
  • Personnel are expected to wear the standard PPE such as mask, gloves, and laboratory gown.
A

Biosafety level 1

25
Q

Bacillus subtilis, Escherichia coli, Adeno-associated virus, Baculovirus, Saccharomyces cerevisae

A

RG-1 organisms

26
Q
  • Handle a broad spectrum of moderate risk agents or organisms, associated with human diseases with different degrees of severity
  • Personnel who works at this type of laboratory normally process human derived specim en such as blood, body fluids, tissues and to extend human cells. Aside from wearing PPE, the personnel have a second barriers such as sink, waste decontamination facilities (autoclave) and biosafety cabinet
A

Biosafety level 2

27
Q
  • Handle organisms that are considered indigenous or exotic agents with potential to be transmitted via respiratory routes.
  • All procedures in processing should be done in a biosafety cabinet with a gas tight aerosol generation chamber.
A

Biosafety level 3

28
Q

Staphylococcus aureus, Herpes simplex virus, Salmonella spp, Measles, Enterovirus,

A

RG-2 organisms

29
Q

Mycobacterium tuberculosis, HIV, HBV, MERS, Vibrio
cholera

A

RG-3 organisms

30
Q

Ebola virus, Marbug virus, Lassa virus, Hendra virus, Nipah virus, Flavivirus, Influenza, Yellow fever, Smallpox, Hemorrhagic fever

A

RG-4 organisms

31
Q
  • Handle extremely dangerous and exotic agents that can be transmitted through air, have no available vaccine or therapeutic cure
  • Personnel who works under this laboratory is required to wear a full-body, air supplied positive pressure suits.
A

Biosafety level 4

32
Q
  • A clinical laboratory should be headed by a registered medical technologist and managed by a pathologist (clinical or anatomical pathologist) who is duly certified by the Philippine Board of Pathology.
  • The number of medical technologist staff in a laboratory depends on the workload and the services provided by the establishment.
A

A.O NO. 2007-0027 (CLINICAL LABORATORY STAFF)

33
Q
  • Approved on June 18, 1966
  • The act was put into effect to regulate the operation and maintenance of clinical laboratories and to require their registration with the Department of Health.
A

R.A NO. 4688 CLINICAL LABORATORY ACT OF 1966

34
Q

Amended subsection (a) of section 11 of A.O No. 201 s. 1973 that describes the requirements for clinical laboratories E.g. pathologist may be authorized to manage and supervise and/or an associate pathologist of not more than three clinical laboratories and/or blood banks continuously located in particular area.

A

A.O NO. 290 s. 1976

35
Q

Describes the rules and regulations regarding implementation of internal and external quality control programs as the requirements for licensing of the clinical laboratories in which a clinical laboratory required to have a quality assurance program.

A

DEPARTMENT MEMORANDUM ORDER NO. 2009-0086

36
Q

covers the inputs, processes, and outputs
including the continuous quality improvement program.

A

Internal quality control

37
Q

requires a clinical laboratory to participate in the National External Assessment Program (NEAP)

A

External quality assessment program

38
Q

NEAP

A

National External Assessment Program

39
Q

EQAP

A

External Quality Assessment Program

40
Q

This memorandum order contains all the designated reference laboratories for EQAP

A

DEPARTMENT MEMORANDUM ORDER NO. 2009-0086

41
Q

national reference laboratory for dengue, influenza, tuberculosis, and other mycobacteria, malaria, and other parasites, bacterial enteric disease, measles,
emerging diseases, and NRL for confirmatory testing of blood units.

A

RITM

42
Q

national reference laboratory for HIV/AIDS, hepatitis,
syphilis, and other sexually transmitted infections

A

SAN LAZARO HOSPITAL

43
Q

NRL for environmental and occupational
health; toxicology, and micronutrient assay

A

EAST AVENUE MEDICAL CENTER

44
Q

NRL for hematology including immunohematology, immunopathology and anatomic pathology

A

NATIONAL KIDNEY AND TRANSPLANT INSTITUTE

45
Q

NRL for biochemistry

A

LUNG CENTER OF THE PHILIPPINES

MTLB211 (8 decks)

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